[Federal Register: January 18, 2008 (Volume 73, Number 13)] [Rules and Regulations] [Page 3379-3385] From the Federal Register Online via GPO Access [wais.access.gpo.gov] [DOCID:fr18ja08-2]
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DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service
9 CFR Parts 93, 94, and 95
[Docket No. APHIS-2006-0026] RIN 0579-AC45
Bovine Spongiform Encephalopathy; Minimal-Risk Regions; Identification of Ruminants, and Processing and Importation of Commodities
AGENCY: Animal and Plant Health Inspection Service, USDA.
ACTION: Final rule.
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SUMMARY: We are amending the regulations regarding the importation of animals and animal products to remove several restrictions regarding the identification of animals and the processing of ruminant materials from regions that present a minimal risk of introducing bovine spongiform encephalopathy into the United States. We are removing these restrictions because they are not necessary to prevent the introduction of bovine spongiform encephalopathy into the United States.
DATES: Effective Date: February 19, 2008.
FOR FURTHER INFORMATION CONTACT: For information regarding ruminant products, contact Dr. Karen James-Preston, Director, Technical Trade Services, Animal Products, National Center for Import and Export, VS, APHIS, 4700 River Road, Unit 38, Riverdale, MD 20737-1231; (301) 734- 4356. For information concerning live ruminants, contact Dr. Freeda Isaac, Director, AOVSA, National Center for Import and Export, VS, APHIS, 4700 River Road, Unit 39, Riverdale, MD 20737-1231; (301) 734- 8364.
SUPPLEMENTARY INFORMATION:
Background
The Animal and Plant Health Inspection Service (APHIS) of the United States Department of Agriculture regulates the importation of animals and animal products into the United States to guard against the introduction of animal diseases not currently present or prevalent in this country. The regulations in 9 CFR parts 93, 94, and 95 prohibit or restrict the importation into the United States of specified animals and animal products to prevent the introduction into the United States of various animal diseases, including bovine spongiform encephalopathy (BSE). In a final rule published in the Federal Register on January 4, 2005 (70 FR 460-553, Docket No. 03-080-3), we amended the regulations regarding the importation of animals and animal products to establish a category of regions that present a minimal risk of introducing BSE into the United States via live ruminants and ruminant products and byproducts, and added Canada to this category. We also established conditions for the importation of certain live ruminants and ruminant products and byproducts from such regions. These regulations are in 9 CFR parts 93, 94, 95, and 96. On November 28, 2005, we published in the Federal Register an interim rule (70 FR 71213-71218, Docket No. 03-080-8) that (1) broadened who is authorized to break the seals on a means of conveyance carrying certain ruminants from Canada and (2) amended the provisions regarding the transiting through the United States of certain ruminant products from Canada to allow for limited direct transloading of the products from one means of conveyance to another in the United States. On March 14, 2006, we published in the Federal Register a technical amendment (71 FR 12994-12998, Docket No. 03-080-9) that clarified our intent with regard to certain provisions in the January 2005 final rule and corrected several inconsistencies within the rule. On August 9, 2006, we published in the Federal Register a proposed rule \1\ (71 FR 45439-45444, Docket No.
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APHIS-2006-0026) to amend the regulations in 9 CFR parts 93, 94, and 95 to remove several restrictions regarding the identification of ruminants and the processing of ruminant materials from BSE minimal- risk regions, as well as BSE-based restrictions on gelatin derived from bovine hides. ---------------------------------------------------------------------------
\1\ To view the proposed rule and the comments we received, go to http://www.regulations.gov/fdmspublic/component/main?main=DocketDetail&d=APHIS-2006-0026 .
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We solicited comments concerning our August 2006 proposed rule (referred to below as the ``proposed rule'') for 60 days ending October 10, 2006. In a document published in the Federal Register on November 9, 2006 (71 FR 65758-65759, Docket No. APHIS-2006-0026), we reopened and extended the deadline for comments until November 24, 2006. We received 10 comments in response to our proposed rule. They were from organizations representing U.S. producers of livestock and livestock products, renderers, and other members of the public. The comments dealt with live animals as well as animal products. We discuss the comments below by topic.
Changes to This Final Rule Based on a September 2007 Final Rule
On September 18, 2007, we published in the Federal Register a final rule (72 FR 53113-53379, Docket No. APHIS-2006-0041; effective November 19, 2007) that established conditions for the importation into the United States from BSE minimal-risk regions of certain bovines and bovine commodities that had not been made eligible for importation by our January 2005 final rule. Some of the changes we made to the regulations in our September 2007 final rule affected regulatory text we had proposed to change in our August 2006 proposed rule, either by rewording text, deleting provisions that would have been changed by our August 2006 proposed rule, or redesignating CFR paragraph references. Consequently, we have made changes to this final rule to reflect the changes made by our September 2007 final rule. In our discussion of this final rule, we identify where those changes occur.
Comments Received in Response to Our August 2006 Proposed Rule
Identification of Live Ruminants Exported to the United States From BSE Minimal-Risk Regions
One of the changes to the regulations we proposed in our August 2006 proposed rule was a broadening of the options of acceptable forms of individual identification of bovines, sheep, and goats exported to the United States from BSE minimal-risk regions (currently only Canada). Under the current regulations in Sec. 93.436, live bovines imported from a BSE minimal-risk region must be individually identified by means of an official eartag of the country of origin. The eartag must be determined by the APHIS Administrator to meet standards equivalent to those for official eartags in the United States, as defined in 9 CFR part 71, and to be traceable to the premises of origin. There is a similar requirement for sheep and goats in Sec. 93.419. However, because Sec. 93.419 refers specifically to sheep and goats from Canada, that section requires that sheep and goats from Canada be individually identified by an official Canadian Food Inspection Agency eartag. In our proposed rule, we proposed to allow for means of individual identification other than eartags for the imported bovines, sheep, and goats. We proposed to provide that the animals must be officially identified with individual identification before the animals' arrival at the port of entry into the United States. We proposed to define officially identified to mean ``individually identified by means of an official identification device or method.'' In Sec. 93.400 of the current regulations, official identification device or method is defined as a means of officially identifying an animal or group of animals using devices or methods approved by the Administrator, including, but not limited to, official tags, tattoos, and registered brands when accompanied by a certificate of inspection from a recognized brand inspection authority. We proposed to add a sentence at the end of that definition to make it clear that, for animals intended for importation into the United States, the particular device or method of identification must have been approved by the Administrator for that type of import before the animal is exported to the United States. Several commenters expressed concern that our proposed change regarding animal identification would hinder the ability to conduct rapid traceback of cattle to their herd of origin in the event BSE is diagnosed in an animal imported from a BSE minimal-risk region. One of the commenters recommended that the identification requirements in the current regulations be retained. Another commenter recommended that the regulations explicitly require that all cattle from a BSE minimal-risk region be individually identified with a device or method that is visible and readable and that includes a unique animal identification number that enables traceback to the herd of origin. We agree with the commenters that the individual identification of cattle--and sheep and goats--imported from a BSE minimal-risk region must be unique to individual animals and allow for rapid traceback of an animal to its herd of origin. The intent of the change we proposed was not to remove that requirement from the regulations, but simply to allow, in addition to eartags, other forms of individual identification that meet those criteria. That is the reason we proposed to provide in the definition of official identification device or method that the identification used must have been approved by the Administrator for that type of import before the animal is exported to the United States. To ensure that there is no misunderstanding of our intent, in this final rule we are specifying in Sec. 93.436(a)(2) and (b)(3) that, before arrival at the port of entry into the United States, each bovine imported into the United States from a BSE minimal-risk region must be officially identified with unique individual identification that is traceable to the premises of origin of the animal.\2\ In Sec. 93.419(c), we are including a similar identification requirement for sheep and goats imported from Canada. ---------------------------------------------------------------------------
\2\ Note: Paragraphs (a)(2) and (b)(3) of Sec. 93.436 were designated as paragraphs (a)(3) and (b)(4), respectively, in our proposed rule, but are redesignated in this final rule to reflect the changes made in our September 2007 final rule. ---------------------------------------------------------------------------
In our August 2006 proposed rule, we proposed to replace the word ``eartag'' with the term ``official identification'' in what, at that time, were paragraphs (b)(8) and (b)(11) of Sec. 93.436. However, our September 2007 final rule removed Sec. 93.436(b)(8) and (b)(11). In addition to addressing the issue of the types of allowable individual identification, two commenters expressed support for identification provisions of the current regulations that we did not propose to change. These are: (1) The provision that no person may alter, deface, remove, or otherwise tamper with the official identification while the animal is in the United States or moving into or through the United States, except that the identification may be removed at slaughter; and (2) the requirement that cattle imported from a BSE minimal-risk region for other than immediate slaughter be identified, before export to the United States, with a permanent mark that indicates the country of origin.
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Gelatin
In Sec. 94.19(f)(2) of our proposed rule, we proposed to allow the importation into the United States of gelatin derived from the hides of bovines from BSE minimal-risk regions, provided the gelatin has not been commingled with materials ineligible for entry into the United States. In accordance with the regulations as amended by our September 2007 final rule, gelatin imported into the United States from a BSE minimal-risk region must either (1) be derived from the bones of bovines subject to a ruminant feed ban equivalent to the requirements established by the U.S. Food and Drug Administration at 21 CFR 589.2000 and from which specified risk materials were removed (Sec. 94.19(f)), or (2) be imported for use in human food, human pharmaceutical products, photography, or some other use that will not result in the gelatin coming into contact with ruminants in the United States (Sec. 94.18(c)). A number of commenters supported allowing the importation of gelatin derived from the hides of bovines from BSE minimal-risk regions. One commenter stated that it does not make sense to allow the importation of gelatin derived from hides of bovines from BSE minimal- risk regions at the same time the regulations restrict the importation of gelatin derived from bones. We disagree that it does not make sense to allow the importation of gelatin derived from hides. Bovine hides have not demonstrated BSE infectivity, even in infected animals, and the safety of bovine hides with regard to BSE is recognized internationally. The World Organization of Animal Health (commonly referred to as the OIE) supported that conclusion in its recommendation that gelatin derived exclusively from the hides of bovines not be subject to import restrictions (OIE Terrestrial Animal Health Code (the Code), 2006, Article 2.3.13.1). The European Commission Scientific Steering Committee reached a similar conclusion regarding the lack of BSE infectivity in hide-derived gelatin, provided contamination with potentially infected materials is avoided (European Commission's Updated Opinion on the Safety with Regard to TSE Risk of Gelatine Derived from Ruminant Bones or Hides, December 2002). In contrast, gelatin derived from the bones of bovines from BSE minimal-risk regions can pose a risk of infectivity unless the risk mitigation measures in Sec. Sec. 94.18(c) and 94.19(f), described above, are taken. The higher BSE risk of bone-derived gelatin is recognized internationally. The OIE Code contains BSE risk mitigation guidelines for gelatin derived from bovines (Article 2.3.13.15). The European Commission Scientific Steering Committee concluded in its Updated Opinion that ``the risk of transmissible spongiform infectivity is much higher with bones, as compared to hides.'' Therefore, we are making no changes based on this comment.
Processing of Non-Ruminant Material in BSE Minimal-Risk Regions
The current regulations in Sec. 95.4(c) allow the importation of certain materials derived from nonruminants from BSE minimal-risk regions only if all steps of processing and storing the material are carried out in a facility that has not been used for the processing and storage of materials derived from ruminants that have been in any region listed in Sec. 94.18(a) of the regulations. The regions listed in Sec. 94.18(a) include BSE minimal-risk regions, as well as regions in which BSE exists and regions that present an undue risk of introducing BSE into the United States. In our proposed rule, we proposed to amend Sec. 95.4(c) so that nonruminant materials processed or stored in BSE minimal-risk regions would no longer need to be processed or stored in facilities separate from those used to process or store materials derived from ruminants from BSE minimal-risk regions. Several commenters supported the proposed change to Sec. 95.4(c). One commenter stated that our intent regarding the proposed change to Sec. 95.4(c) was not easily understandable from the wording we used in the regulatory text of the proposed rule. In Sec. 95.4(c)(2) and (3) of the proposed rule, we made reference to regions listed in Sec. 94.18(a)(1), (a)(2), and (a)(3). Those paragraphs list the following types of regions: Sec. 94.18(a)(1) lists regions in which BSE exists; Sec. 94.18(a)(2) lists regions that, because of import requirements less restrictive than those that would be acceptable for import into the United States and/or because of inadequate surveillance, present an undue risk of introducing BSE into the United States; and Sec. 94.18(a)(3) lists BSE minimal-risk regions (currently only Canada). The commenter stated that the regulations would be clearer if, when referring to Sec. 94.18(a)(1), (a)(2), and (a)(3), we also indicated the BSE category of regions listed in those paragraphs. Because in Sec. 95.4(c) as proposed we reference paragraphs that contain lists that can be easily described, we agree it would be useful to the reader if those references included a description of the content of each of those paragraphs. Therefore, we are including such descriptions in Sec. 95.4(c)(2) and (c)(3) in this rule.
Tallow
One commenter addressed the provisions in Sec. 95.4 regarding the importation of tallow. The commenter stated that APHIS should follow the OIE guideline of allowing the importation from BSE minimal-risk regions of tallow with no more than 0.15 percent impurities. We did not propose to make any changes to the regulations regarding the importation of tallow from BSE minimal-risk regions. However, the commenter is correct that the wording in Sec. 95.4 regarding tallow differs from the OIE guidelines in one respect. One of the criteria in Sec. 95.4 for the importation of tallow derived from bovines from BSE minimal-risk regions is that the tallow be composed of less than 0.15 percent insoluble impurities. This differs slightly from the OIE guidelines, which recommend allowing the importation of tallow with a maximum level of insoluble impurities of 0.15 percent in weight. The intent of our January 2005 final rule, as indicated on page 501 of the preamble to that rule, was to allow the importation of tallow composed of a maximum level of insoluble impurities of 0.15 percent in weight. However, the amendatory text of that rule incorrectly used the phrase ``less than 0.15 percent.'' Therefore, to make the wording of the regulations consistent with our stated intent, in this rule we are amending Sec. 95.4 to require that bovine-derived tallow imported from a BSE minimal-risk region be composed of a maximum level of insoluble impurities of 0.15 percent in weight.
Other Comments
In our proposed rule, we proposed to specify in Sec. 94.19(f)(1) (redesignated as Sec. 94.19(g)(1) in our September 2007 final rule) as one of the conditions for the importation of gelatin derived from the bones of bovines from BSE minimal-risk regions that the gelatin not have been commingled with materials ineligible for entry into the United States. Other than that, we did not propose to change the provisions regarding gelatin derived from bones. One commenter, however, objected to the current regulations that allow the importation of bone-derived gelatin from BSE minimal-risk regions (currently only Canada). The commenter contended that the current regulations
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are erroneously based on the determination that Canada is a BSE minimal-risk region, and that Canada should instead be considered a country of undetermined BSE risk according to OIE recommendations. For similar reasons, a commenter opposed our proposal to no longer require that nonruminant materials processed or stored in BSE minimal- risk regions be processed or stored in facilities separate from those used to process or store materials derived from ruminants from BSE minimal-risk regions. The commenter expressed concern regarding what the commenter termed the ``undetermined prevalence'' of BSE in Canada and the detection of BSE in cows that were born after Canada implemented its feed ban. The commenter stated that APHIS should reconsider the proposed change on the basis that BSE infectivity is known to have circulated in Canada as recently as 2002. We are making no changes based on these comments. APHIS recognized Canada as a BSE minimal-risk region in our January 2005 final rule that was published following notice-and-comment rulemaking. We did not propose to revisit that determination in our August 2006 proposed rule and do not consider such a change to the BSE risk status of Canada to be scientifically supportable or appropriate. One of the conditions for being recognized by APHIS as a BSE minimal-risk region is that the region have in place and maintain risk mitigation measures adequate to prevent widespread exposure and/or establishment of the disease. In classifying Canada as a BSE minimal-risk region in our January 2005 final rule, we determined that such mitigation measures are in place and are maintained in Canada. We do not consider the diagnosis of BSE in several cows born after the establishment of the Canadian feed ban to be unexpected. Experience worldwide has demonstrated that, even in countries with an effective feed ban in place, BSE has occurred in cattle born after a feed ban was implemented. No regulatory effort can ensure 100 percent compliance. Isolated incidents, such as feed made from nonprohibited material being contaminated with prohibited material during processing, can occur due to human error. However, such isolated incidents are not epidemiologically significant and do not contribute to further spread of BSE, especially when considered in light of the entire risk pathway and its attendant risk mitigations. One commenter made the general request that APHIS delete from the regulations the provisions regarding imports from BSE minimal-risk regions until further research and surveillance is done regarding all transmissible spongiform encephalopathies. The commenter did not address any specific provision of our proposal, and we are making no changes based on the comment. One commenter requested that APHIS not require that products imported from a BSE minimal-risk region under the provisions of Sec. 95.4 be accompanied by original signed certification, provided certain specified risk mitigation measures are in place. We consider the issue raised by the commenter to be outside the scope of the proposed rule, and are making no changes based on the comment. However, we will take the commenter's request into consideration in assessing the need for future rulemaking. Several commenters expressed general opposition to the importation of ruminants from Canada, but did not specifically address provisions of the proposed rule. We are making no changes based on those comments.
Additional Nonsubstantive Changes
In addition to those discussed above, we are making several other nonsubstantive changes in this final rule to be consistent with wording changes and paragraph redesignations made in our September 2007 final rule.
Adoption of the Proposed Rule With Changes
Therefore, for the reasons given in the proposed rule and in this document, we are adopting the proposed rule as a final rule, with the changes discussed in this document.
Executive Order 12866 and Regulatory Flexibility Act
This rule has been reviewed under Executive Order 12866. The rule has been determined to be not significant for the purposes of Executive Order 12866 and, therefore, has not been reviewed by the Office of Management and Budget. The Regulatory Flexibility Act requires agencies to evaluate the potential effects of their proposed and final rules on small businesses, small organizations, and small governmental jurisdictions. We have prepared a final regulatory flexibility analysis, which is set forth below. In a final rule published in January 2005, we established a category of regions that present a minimal risk of introducing BSE into the United States via live ruminants and ruminant products and byproducts, and added Canada to that category. We also established conditions for the importation of certain live ruminants and ruminant products and byproducts from such regions. A final rule published in September 2007 included conditions for the importation of additional commodities from BSE minimal-risk regions. In this rule, we are removing certain restrictions on imports from BSE minimal-risk regions that concern animal identification, the derivation of bovine gelatin, and the processing of ruminant and nonruminant materials. We have determined these restrictions are not necessary to prevent the introduction of BSE into the United States. Instead of limiting the type of allowable individual identification on bovines, sheep, and goats imported from a BSE minimal-risk region to an official eartag of the country of origin, we are allowing unique individual identification of animals by means other than eartags, provided the APHIS Administrator has approved the manner of identification for the type of animal intended for importation and the identification is traceable to the premises of origin of the animal. Instead of limiting the importation of bovine-derived gelatin from BSE minimal-risk regions to gelatin derived from bones, we are allowing the importation of hide-derived gelatin, provided certain conditions are met. We are also allowing nonruminant material that is processed in BSE minimal-risk regions--such as processed animal protein, tankage, offal, certain tallow, processed fats and oils, and derivatives of processed animal protein, tankage, and offal--to be processed in facilities that also process material derived from ruminants from the minimal-risk region. We address below the potential economic effect of each of these changes.
Animal Identification
Giving owners of bovines, sheep, and goats in BSE minimal-risk regions the option of individually identifying animals being exported to the United States by means other than eartags is not expected to affect U.S. small entities. This amendment simply acknowledges that there are effective means of individual identification other than eartags, as long as the chosen device or method has been approved by the APHIS Administrator before the animal is exported to the United States. The unique individual identification must be traceable to the premises of origin of the animal (as is required of the eartags currently used), a disease control
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measure that will benefit all U.S. cattle producers, the majority of which are small entities.
Hide-Derived Gelatin
This amendment, by allowing the importation of gelatin derived from bovine hides in addition to gelatin derived from bovine bones, could affect U.S. entities by providing an additional source of gelatin imported from Canada. Gelatin is derived from collagen, an insoluble fibrous protein that is the principal constituent of connective tissues and bones. The main raw materials used in gelatin production are cattle bones, cattle hides, and porkskins. Gelatin recovered from bone is used primarily in photographic applications. Porkskin is currently the most significant raw material source for production of edible gelatin in North America. Cattle hides are the least used raw material for gelatin in North America today. Cattle hides sourced by member companies of the Gelatin Manufacturers Institute of America for the production of gelatin for food use are purchased from a small number of tanneries in the United States. We do not have information about the quantity of hide-derived gelatin that would be imported from Canada because of this rule, nor do we have an estimate of the number of U.S. small entities that would be affected. Production of animal hides is classified by the North American Industry Classification System (NAICS) under ``Animal (except Poultry) Slaughtering'' (NAICS 311611), for which the small entity definition is businesses with not more than 500 employees. In the initial regulatory flexibility analysis we conducted for our August 2006 proposed rule, we requested information that would allow us to better understand the number and size of entities that might be affected by allowing hide-derived bovine gelatin to be imported from BSE minimal-risk regions (currently only Canada), but we received no information of this type.
Nonruminant Material
This amendment removes the requirement that nonruminant material that is processed in BSE minimal-risk regions be processed in a facility that does not also process material derived from ruminants from the minimal-risk region. If this amendment results in changes in the amounts of nonruminant material imported by the United States, then U.S. entities could be affected. Affected nonruminant material may include processed animal protein, tankage, offal, certain tallow, processed fats and oils, and derivatives of processed animal protein, tankage, and offal. Facilities that produce these commodities are classified under ``Rendering and Meat By-product Processing'' (NAICS 311613), for which the small entity definition is businesses with not more than 500 employees. We do not have a basis for estimating the change in imports of Canadian nonruminant materials that might result from this rule, nor do we know the number or size of U.S. entities that will be affected. In our initial regulatory flexibility analysis, we requested information from the public regarding the number of small entities that might be affected and the likely magnitude of the effect, but we received no information of this type. We do not foresee any significant economic effects on small entities because of this rule. There are no significant alternatives to this rule that would accomplish the stated objectives. Without the rule, unnecessary restrictions on certain exports to the United States from BSE minimal-risk regions will continue. With the rule, animal exporters in BSE minimal-risk regions will have the option of individually identifying bovines, sheep, and goats being exported to the United States by means other than eartags; U.S. entities will be allowed to import hide-derived, in addition to bone-derived, gelatin from BSE minimal-risk regions; and ruminant and nonruminant materials that are processed in the same facility in a BSE minimal-risk region will be allowed to be exported to the United States.
Executive Order 12988
This final rule has been reviewed under Executive Order 12988, Civil Justice Reform. This rule: (1) Preempts all State and local laws and regulations that are inconsistent with this rule; (2) has no retroactive effect; and (3) does not require administrative proceedings before parties may file suit in court challenging this rule.
Paperwork Reduction Act
This rule contains no new information collection or recordkeeping requirements under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.).
List of Subjects
9 CFR Part 93
Animal diseases, Imports, Livestock, Poultry and poultry products, Quarantine, Reporting and recordkeeping requirements.
9 CFR Part 94
Animal diseases, Imports, Livestock, Meat and meat products, Milk, Poultry and poultry products, Reporting and recordkeeping requirements.
9 CFR Part 95
Animal feeds, Hay, Imports, Livestock, Reporting and recordkeeping requirements, Straw, Transportation.
0 Accordingly, we are amending 9 CFR parts 93, 94, and 95 as follows:
PART 93--IMPORTATION OF CERTAIN ANIMALS, BIRDS, FISH, AND POULTRY, AND CERTAIN ANIMAL, BIRD, AND POULTRY PRODUCTS; REQUIREMENTS FOR MEANS OF CONVEYANCE AND SHIPPING CONTAINERS
0 1. The authority citation for part 93 continues to read as follows:
Authority: 7 U.S.C. 1622 and 8301-8317; 21 U.S.C. 136 and 136a; 31 U.S.C. 9701; 7 CFR 2.22, 2.80, and 371.4.
0 2. Section 93.400 is amended by revising the definition of official identification device or method and adding a definition of officially identified, in alphabetical order, to read as follows:
Sec. 93.400 Definitions.
* * * * * Official identification device or method. A means of officially identifying an animal or group of animals using devices or methods approved by the Administrator, including, but not limited to, official tags, tattoos, and registered brands when accompanied by a certificate of inspection from a recognized brand inspection authority. For animals intended for importation into the United States, the device or method of identification used must have been approved by the Administrator for that type of import before the animal is exported to the United States. * * * * * Officially identified. Individually identified by means of an official identification device or method. * * * * *
Sec. 93.405 [Amended]
0 3. In Sec. 93.405, paragraph (a)(4) is amended by removing the word ``eartag'' and adding in its place the words ``official identification''.
0 4. Section 93.419 is amended by revising paragraph (c) and paragraphs (e)(2), (e)(5), (e)(7)(i), and (e)(7)(iii) to read as follows:
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Sec. 93.419 Sheep and goats from Canada.
* * * * * (c) Any sheep or goats imported from Canada must not be pregnant, must be less than 12 months of age when imported into the United States and when slaughtered, must be from a flock or herd subject to a ruminant feed ban equivalent to the requirements established by the U.S. Food and Drug Administration at 21 CFR 589.2000, and, before the animal's arrival at the port of entry into the United States, must be officially identified with unique individual identification that is traceable to the premises of origin of the animal. No person may alter, deface, remove, or otherwise tamper with the official identification while the animal is in the United States or moving into or through the United States, except that the identification may be removed at the time of slaughter. The animals must be accompanied by the certification issued in accordance with Sec. 93.405 that states, in addition to the statements required by Sec. 93.405, that the conditions of this paragraph have been met. Additionally, for sheep and goats imported for immediate slaughter, the certificate must state that the conditions of paragraphs (d)(1) through (d)(3) of this section have been met, and, for sheep and goats imported for other than immediate slaughter, the certificate must state that the conditions of paragraphs (e)(1) and (e)(2) of this section have been met. * * * * * (e) * * * * * * * * (2) The animals may be moved from the port of entry only to a feedlot designated in accordance with paragraph (e)(7) of this section and must be accompanied from the port of entry to the designated feedlot by APHIS Form VS 17-130 or other movement documentation deemed acceptable by the Administrator, which must identify the physical location of the feedlot, the individual responsible for the movement of the animals, and the individual identification of each animal, which includes the official identification required under paragraph (c) of this section and any other identification present on the animal, including registration number, if any: * * * * * (5) The animals must be accompanied to the recognized slaughtering establishment by APHIS Form VS 1-27 or other documentation deemed acceptable by the Administrator, which must identify the physical location of the recognized slaughtering establishment, the individual responsible for the movement of the animals, and the individual identification of each animal, which includes the official identification required under paragraph (c) of this section and any other identification present on the animal, including registration number, if any; * * * * * (7) * * * (i) Will not remove official identification from animals unless medically necessary, in which case new official identification will be applied and cross referenced in the records; * * * * * (iii) Will maintain records of the acquisition and disposition of all imported sheep and goats entering the feed lot, including the official identification number and all other identifying information, the age of each animal, the date each animal was acquired and the date each animal was shipped to slaughter, and the name and location of the plant where each animal was slaughtered. For Canadian animals that die in the feedlot, the feedlot will remove the official identification device if affixed to the animal, or will record any other official identification on the animal and place the official identification device or record of official identification in a file with a record of the disposition of the carcass; * * * * *
0 5. Section 93.436 is amended by revising paragraphs (a)(2) and (b)(3) to read as set forth below.
Sec. 93.436 Ruminants from regions of minimal risk for BSE.
* * * * * (a) * * * (2) Before the animal's arrival at the port of entry into the United States, each bovine imported into the United States from a BSE minimal-risk region must be officially identified with unique individual identification that is traceable to the premises of origin of the animal. No person may alter, deface, remove, or otherwise tamper with the official identification while the animal is in the United States or moving into or through the United States, except that the identification may be removed at slaughter; * * * * * (b) * * * (3) Before the animal's arrival at the port of entry into the United States, each bovine imported into the United States from a BSE minimal-risk region must be officially identified with unique individual identification that is traceable to the premises of origin of the animal. No person may alter, deface, remove, or otherwise tamper with the official identification while the animal is in the United States or moving into or through the United States, except that the identification may be removed at slaughter; * * * * *
PART 94--RINDERPEST, FOOT-AND-MOUTH DISEASE, FOWL PEST (FOWL PLAGUE), EXOTIC NEWCASTLE DISEASE, AFRICAN SWINE FEVER, CLASSICAL SWINE FEVER, AND BOVINE SPONGIFORM ENCEPHALOPATHY: PROHIBITED AND RESTRICTED IMPORTATIONS
0 6. The authority citation for part 94 continues to read as follows:
Authority: 7 U.S.C. 450, 7701-7772, 7781-7786, and 8301-8317; 21 U.S.C. 136 and 136a; 31 U.S.C. 9701; 7 CFR 2.22, 2.80, and 371.4.
0 7. In Sec. 94.19, paragraph (f) is revised to read as follows:
Sec. 94.19 Restrictions on importation from BSE minimal-risk regions of meat and edible products from ruminants.
* * * * * (f) Gelatin other than that allowed importation under Sec. 94.18(c). The gelatin is derived from: (1) The bones of bovines subject to a ruminant feed ban equivalent to the requirements established by the U.S. Food and Drug Administration at 21 CFR 589.2000 and from which SRMs were removed, and the gelatin has not been commingled with materials ineligible for entry into the United States; or (2) The hides of bovines, and the gelatin has not been commingled with materials ineligible for entry into the United States. * * * * *
PART 95--SANITARY CONTROL OF ANIMAL BYPRODUCTS (EXCEPT CASINGS), AND HAY AND STRAW, OFFERED FOR ENTRY INTO THE UNITED STATES
0 8. The authority citation for part 95 continues to read as follows:
Authority: 7 U.S.C. 8301-8317; 21 U.S.C. 136 and 136a; 31 U.S.C. 9701; 7 CFR 2.22, 2.80, and 371.4.
0 9. Section 95.4 is amended as follows: 0 a. Paragraph (c)(2) is revised to read as set forth below. 0 b. Paragraphs (c)(3) through (c)(7) are redesignated as paragraphs (c)(4) through (c)(8), respectively. 0 c. A new paragraph (c)(3) is added to read as set forth below.
[[Page 3385]]
0 d. Newly redesignated paragraph (c)(7) is revised to read as set forth below. 0 e. Paragraph (g)(2) is revised to read as set forth below.
Sec. 95.4 Restrictions on the importation of processed animal protein, offal, tankage, fat, glands, certain tallow other than tallow derivatives, and blood and blood products due to bovine spongiform encephalopathy.
* * * * * (c) * * * (2) In regions listed in Sec. 94.18(a)(1) or (a)(2) of this subchapter as regions in which BSE exists or that present an undue risk of introducing BSE into the United States, all steps of processing and storing the material are carried out in a facility that has not been used for the processing and storage of materials derived from ruminants that have been in any region listed in Sec. 94.18(a) of this subchapter. (3) In regions listed in Sec. 94.18(a)(3) of this subchapter as BSE minimal-risk regions, all steps of processing and storing the material are carried out in a facility that has not been used for the processing and storage of materials derived from ruminants that have been in any region listed in Sec. 94.18(a)(1) or (a)(2) of this subchapter as a region in which BSE exists or a region that presents an undue risk of introducing BSE into the United States. * * * * * (7) Each shipment to the United States is accompanied by an original certificate signed by a full-time, salaried veterinarian of the government agency responsible for animal health in the region of export certifying that the conditions of paragraphs (c)(1) through (c)(4) of this section have been met; except that, for shipments of animal feed from a region listed in Sec. 94.18(a)(3) of this subchapter, the certificate may be signed by a person authorized to issue such certificates by the veterinary services of the national government of the region of origin. * * * * * (g) * * * (2) The tallow is composed of a maximum level of insoluble impurities of 0.15 percent in weight; * * * * *
Done in Washington, DC, this 14th of January 2008. Kevin Shea, Acting Administrator, Animal and Plant Health Inspection Service. [FR Doc. E8-883 Filed 1-17-08; 8:45 am]
BILLING CODE 3410-34-P
http://a257.g.akamaitech.net/7/257/2422/01jan20081800/edocket.access.gpo.gov/2008/E8-883.htm
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 [wais.access.gpo.gov] [DOCID:fr09ja07-21]
http://www.regulations.gov/fdmspublic/component/main?main=DocumentDetail&o=09000064801f8152
BSE; MRR; IMPORTATION OF LIVE BOVINES AND PRODUCTS DERIVED FROM BOVINES [Docket No. APHIS-2006-0041] RIN 0579-AC01 Date: January 9, 2007 at 9:08 am PST
http://www.regulations.gov/fdmspublic/component/main?main=DocumentDetail&o=09000064801f3412
APHIS-2006-0041-0006 TSE advisory committee for the meeting December 15, 2006
http://www.regulations.gov/fdmspublic/ContentViewer?objectId=09000064801f3413&disposition=attachment&contentType=msw8
Response to Public Comments on the Harvard Risk Assessment of Bovine Spongiform Encephalopathy Update, October 31, 2005
INTRODUCTION
The United States Department of Agriculture’s Food Safety and Inspection Service (FSIS) held a public meeting on July 25, 2006 in Washington, D.C. to present findings from the Harvard Risk Assessment of Bovine Spongiform Encephalopathy Update, October 31, 2005 (report and model located on the FSIS website:
http://www.fsis.usda.gov/Science/Risk_Assessments/index.asp
Comments on technical aspects of the risk assessment were then submitted to FSIS. Comments were received from Food and Water Watch, Food Animal Concerns Trust (FACT), Farm Sanctuary, R-CALF USA, Linda A Detwiler, and Terry S. Singeltary. This document provides itemized replies to the public comments received on the 2005 updated Harvard BSE risk assessment. Please bear the following points in mind:
snip...see full text 33 pages ;
http://www.fsis.usda.gov/PDF/BSE_Risk_Assess_Response_Public_Comments.pdf
From: Terry S. Singeltary Sr. [flounder9@verizon.net] Sent: Monday, July 24, 2006 1:09 PM To: FSIS RegulationsComments Subject: [Docket No. FSIS-2006-0011] FSIS Harvard Risk Assessment of Bovine Spongiform Encephalopathy (BSE)
Page 1 of 98
8/3/2006
Greetings FSIS,
I would kindly like to comment on the following ;
FULL TEXT ;
http://www.fsis.usda.gov/OPPDE/Comments/2006-0011/2006-0011-1.pdf
ANIMAL HEALTH REPORT 2006 (BSE h-BASE EVENT IN ALABAMA, Scrapie, and CWD)
http://animalhealthreport2006.blogspot.com/
Tuesday, January 1, 2008
BSE OIE USDA
http://madcowtesting.blogspot.com/2008/01/bse-oie-usda.html
IN A NUT SHELL ;
(Adopted by the International Committee of the OIE on 23 May 2006)
11. Information published by the OIE is derived from appropriate declarations made by the official Veterinary Services of Member Countries.The OIE is not responsible for inaccurate publication of country disease status based on inaccurate information or changes in epidemiological status or other significant events that were not promptly reported to then Central Bureau............
http://www.oie.int/eng/Session2007/RF2006.pdf
SO, the OIE BSE MRR status, is based on whatever information and data the given BSE countries give them to go by.
LIKE i have stated time and time again, OIE BSE MRR policy is bought and paid for by your local cattle dealer.
THE BSE MRR policy is nothing more than a legal tool to trade TSE globally.
I urge that the BSE MRR policy be repealed, and the BSE GBR risk assessments be upgraded to include all strains of TSE, including the USA H-BASE, but to even go further, and include all TSE in ALL species. ...TSS
SEE FULL TEXT ;
http://madcowtesting.blogspot.com/
Terry S. Singeltary Sr. P.O. Box 42 Bacliff, Texas USA 77518
Friday, January 18, 2008
Tuesday, January 1, 2008
BSE OIE USDA
Subject: OIE BSE RECOMMENDATION FOR USA, bought and paid for by your local cattle dealers i.e. USDA Date: May 14, 2007 at 9:00 am PST
OIE BSE RECOMMENDATION FOR USA, bought and paid for by your local cattle dealers i.e. USDA
STATEMENT BY DR. RON DEHAVEN REGARDING OIE RISK RECOMMENDATION
March 9, 2007
“In October 2006, the U.S. Department of Agriculture submitted an application and supporting documents to the World Organization for Animal Health (OIE) to formally request country classification for bovine spongiform encephalopathy (BSE) risk. The OIE undertakes a thorough review process before recommending a risk classification, and then provides an opportunity for all delegate countries to review the recommendations and present comments prior to final adoption of a country’s classification at the OIE’s General Assembly meeting in May.
“While we recognize that a final classification decision will not be made by the OIE until May, we feel it is important to be responsive to questions we are now being asked about the risk classification recommended for the United States. The OIE Scientific Commission has endorsed the recommendation from an OIE expert panel that the United States be classified as “controlled risk” for BSE.
“The controlled risk classification recognizes that OIE-recommended, science-based mitigation measures are in place to effectively manage any possible risk of BSE in the cattle population. This recommendation provides strong support that U.S. regulatory controls are effective and that U.S cattle and products from cattle of all ages can be safely traded in accordance with international guidelines, due to our interlocking safeguards.
“The OIE risk classification process is an essential step in promoting trade and understanding of this disease. We appreciate OIE’s review of our application, as well as its leadership in developing sound, science-based guidelines that will help countries standardize regulations and import requirements. We look forward to the final adoption of this classification, which will be announced at the OIE meeting in May.”
# http://www.aphis.usda.gov/newsroom/content/2007/03/OIE_statement3-9-07.shtml
Sample Size Estimate for BSE Ongoing Surveillance
July 20, 2006
Purpose, rationale, and objectives of surveillance
Animal and public health concerns about bovine spongiform encephalopathy (BSE) have led to the establishment of active surveillance programs among other regulatory measures to monitor and prevent disease. Active surveillance for BSE was initiated in the United States in 1990. In response to identification of a BSE-affected imported dairy cow in December 2003, the U.S. Enhanced BSE Surveillance Program was implemented in June 2004. Through these efforts, two cases of BSE were identified through March 2006. Both cases were in beef cattle over 10 years old (born before the feed ban of 1997), one located in Texas and one in Alabama.
Based on data collected in the United States over the last 7 years, including over a half million samples from the Enhanced Surveillance program, the USDA has developed an estimate of prevalence of BSE among U.S. cattle that was extremely low, projected at less than one case per million animals in the standing adult cattle population at the 95 percent confidence level (APHIS 2006a). In addition, the USDA demonstrated that surveillance efforts to date far exceed the World Organization for Animal Health (OIE) “type A” surveillance recommendations. Prevalence is expected to decline as long as mitigation efforts that maintain low risk for introduction and spread of the BSE agent among U.S. cattle are equivalent to or better than those evaluated by the Harvard Risk Assessment (Cohen et al., 2001, 2003).
The principal purposes of ongoing BSE surveillance are:
1. To continue to monitor the BSE status of U.S. cattle.
2. To provide mechanisms for detection of BSE prevalence if it were to increase above 1 infected animal per million adults.
In addition, we aim to meet the objective of conducting ongoing surveillance at a level that meets or exceeds OIE surveillance recommendations. We believe this objective is reached by the following sampling strategy, which is sufficient to detect BSE at 1 infected animal per 1,000,000 adult cattle in the population with a high degree of confidence.
Sample Size to Meet OIE Surveillance Recommendations
APHIS is committed to maintaining BSE surveillance that at least meets OIE guidelines. The OIE surveillance guidelines for BSE recommend a target number of surveillance points for Type A surveillance based on the size of a country’s cattle population. These points are accrued over 7 consecutive years, and are weighted according to the surveillance stream and age of the animal sampled. For a large cattle population, using the design prevalence of 1 case per 100,000 adult cattle and 95 percent confidence, 300,000 total points over 7 years, or 42,857 points per year, are required for Type A surveillance (OIE 2005).
The four surveillance streams identified in the OIE Code are clinical suspects; casualty slaughter; fallen stock; and healthy slaughter. OIE guidelines recommend sampling from at least three of the four surveillance streams. BSE surveillance efforts in the United States have always focused on the three surveillance streams where BSE is more likely to be found – clinical suspects, casualty slaughter, and fallen stock. During the 7 consecutive years prior to March 17, 2006, the United States collected 735,213 BSE samples from these surveillance streams and accumulated 2,973,804 OIE points (APHIS 2006b).
As shown in the calculation below, if the ongoing surveillance plan continues similar sample numbers from these surveillance streams, approximately 10,500 cattle per year would be sufficient to meet the OIE minimum number of sample points for Type A surveillance.
2,973,804 points ÷ 735,213 samples = 4.1 points per sample and 42,857 points required per year ÷ 4.1 points per sample = 10,453 samples per year
Sample Size for BSE Prevalence Estimates
The OIE minimum number of samples as outlined would be sufficient for a design prevalence of 1 case per 100,000 adult cattle. However, in the interest of maintaining confidence in previous BSE prevalence estimates, a more sensitive design prevalence of 1 case per 1 million adult cattle will be adopted for ongoing surveillance. The BSurvE model (Wilesmith et al., 2004) can be used to help estimate the number of samples necessary to achieve this level of detection. This model determines sample point values based on a particular population’s demographics.
The point tables described by OIE surveillance guidelines were designed using the BSurvE model to represent a conservative scenario (e.g., low point value and greater number of samples) of the characteristics of the cattle populations of all of its member countries. These demographic characteristics describe a hypothetic population that culls cattle very rapidly (mean age of approximately 4 years) and results in point values that are lower than the BSurvE model would calculate for cattle in most countries. In the United States, however, demographic data indicate 25 percent of the adult cattle population of approximately 42 million are dairy production type and 75% are percent beef cattle (NASS 2005). While the U.S. dairy population undergoes rapid culling similar to the characteristics used to develop the OIE table, beef cattle generally remain in the herd to a much older age until they no longer produce calves. Because actual U.S. data are available regarding population characteristics, it is appropriate to base the sample size estimates on the points calculated through BSurvE given U.S. demographics (these points are hereafter referred to as “analytical points”). The higher average age at which beef cattle are culled influences the BSurvE output and results in substantially higher point values. Hence, sample values calculated with BSurvE from actual U.S. data result in higher point values than the conservative OIE estimates. Each analytical point calculated by BSurvE corresponds to a single nontargeted sample (Wilesmith et al., 2004).
According to OIE, BSurvE and Cannon and Roe (1982) calculations, the required number of non-targeted samples needed to detect a prevalence of 1 case per million adult cattle with 95% confidence (given a population size of 42 million adult cattle) is 3,000,000, 2,995,730, and 2,891,389, respectively. Conservatively using the value of 3 million, we calculate that we will need to accumulate 428,571 analytical points (with negative results) per year across a period of 7 years to meet this objective. 3,000,000 analytical points ÷ 7 years = 428,571 analytical points per year The prevalence analysis conducted on U.S. surveillance data collected from March, 1999 through March 2006 reports 6,745,010 points resulting from 735,213 samples. The average sample was worth 9.5 analytical points.1 6,745,010 analytic points ÷ 735,213 samples = 9.5 analytic points per sample If USDA maintained an equivalent mix of surveillance streams during ongoing surveillance, then approximately 45,113 samples per year would be required to meet this objective. 428,571 analytical points per year ÷ 9.5 analytical points per sample = 45,113 samples per year However, greater than one half million of the samples from Enhanced Surveillance were collected from fallen stock – the surveillance stream that produced the lowest point values. Sampling efforts can be focused on higher value surveillance streams – clinical suspects and casualty slaughter – with a limited number of samples obtained from the fallen stock surveillance stream. This will substantially increase the average point value per sample. Therefore, we estimate that 40,000 samples collected from these three surveillance streams – with a focus on clinical suspects and casualty slaughter - will exceed the number of points necessary to maintain confidence that prevalence is less than one infected animal per million adult cattle. Further, since the data are analyzed over 7 consecutive years, the estimate of sample size may be adjusted each year as appropriate to assure a robust prevalence estimate.
References: APHIS (Animal and Plant Health Inspection Service) (2006a). An Estimate of the Prevalence of BSE in the United States. USDA: APHIS: VS: Centers for Epidemiology and Animal Health, National Surveillance Unit. Accessed May 5, 2006, online at http://www.aphis.usda.gov/newsroom/hot_issues/bse/content/printable_version/BSEprevalenceestimate4- 26-06.pdf APHIS (Animal and Plant Health Inspection Service) (2006b). Summary of BSE Enhanced Surveillance in the United States. USDA: APHIS: VS: Centers for Epidemiology and Animal Health, National Surveillance Unit. Accessed May 5, 2006, online at http://www.aphis.usda.gov/newsroom/hot_issues/bse/content/printable_version/SummaryEnhancedBS E-Surv4-26-06.pdf Cannon RM, Roe RT (1982). Livestock Disease Surveys: A Field Manual for Veterinarians, Australian Bureau of Animal Health, Canberra. Cohen JT, Duggar K, Gray G, Kreindel S, Abdelrahman H, HabteMariam T, Oryang D, Tameru B (2001, 2003). Evaluation of the Potential for Bovine Spongiform Encephalopathy in the United States. Harvard Center for Risk Analysis/Harvard School of Public Health and Center for Computational Epidemiology, College of Veterinary Medicine, Tuskegee University. November 2001, (revised October 2003). Available at http://www.aphis.usda.gov/lpa/issues/bse/madcow.pdf. NASS (2005) Cattle, National Agricultural Statistics Service, USDA. Washington, D.C. Released January 28, 2005, by the National Agricultural Statistics Service (NASS), Agricultural Statistics Board, U.S. Department of Agriculture. Available December 15, 2005, at: http://usda.mannlib.cornell.edu/reports/nassr/livestock/pct-bb/catl0101.txt OIE (Office International des Epizooties) (2005). Appendix 3.8.4: Surveillance for bovine spongiform encephalopathy. In: Terrestrial animal health code, 14th ed., Paris, 2005. Wilesmith J, Morris R, Stevenson M, Cannon R, Prattley D, and Benard H (2004). Development of a Method for the Evaluation of National Surveillance Data and Optimization of National Surveillance Strategies for Bovine Spongiform Encephalopathy. European Union TSE Community Reference Laboratory, Veterinary Laboratories Agency, Weybridge, England.
http://www.aphis.usda.gov/peer_review/downloads/BSE_sample_size_ongoing_surv_after.pdf
does not compute. fuzzy math. full formula below. ...TSS
-MORE
Office of the United States Attorney District of Arizona
FOR IMMEDIATE RELEASE For Information Contact Public Affairs
February 16, 2007 WYN HORNBUCKLE Telephone: (602) 514-7625 Cell: (602) 525-2681
CORPORATION AND ITS PRESIDENT PLEAD GUILTY TO DEFRAUDING GOVERNMENT’S MAD COW DISEASE SURVEILLANCE PROGRAM
PHOENIX -- Farm Fresh Meats, Inc. and Roland Emerson Farabee, 55, of Maricopa, Arizona, pleaded guilty to stealing $390,000 in government funds, mail fraud and wire fraud, in federal district court in Phoenix.U.S. Attorney Daniel Knauss stated, “The integrity of the system that tests for mad cow disease relies upon the honest cooperation of enterprises like Farm Fresh Meats. Without that honest cooperation, consumers both in the U.S. and internationally are at risk. We want to thank the USDA’s Office of Inspector General for their continuing efforts to safeguard the public health and enforce the law.” Farm Fresh Meats and Farabee were charged by Information with theft of government funds, mail fraud and wire fraud. According to the Information, on June 7, 2004, Farabee, on behalf of Farm Fresh Meats, signed a contract with the U.S. Department of Agriculture (the “USDA Agreement”) to collect obex samples from cattle at high risk of mad cow disease (the “Targeted Cattle Population”). The Targeted Cattle Population consisted of the following cattle: cattle over thirty months of age; nonambulatory cattle; cattle exhibiting signs of central nervous system disorders; cattle exhibiting signs of mad cow disease; and dead cattle. Pursuant to the USDA Agreement, the USDA agreed to pay Farm Fresh Meats $150 per obex sample for collecting obex samples from cattle within the Targeted Cattle Population, and submitting the obex samples to a USDA laboratory for mad cow disease testing. Farm Fresh Meats further agreed to maintain in cold storage the sampled cattle carcasses and heads until the test results were received by Farm Fresh Meats.
Evidence uncovered during the government’s investigation established that Farm Fresh Meats and Farabee submitted samples from cattle outside the Targeted Cattle Population. Specifically, Farm Fresh Meats and Farabee submitted, or caused to be submitted, obex samples from healthy, USDA inspected cattle, in order to steal government moneys.
Evidence collected also demonstrated that Farm Fresh Meats and Farabee failed to maintain cattle carcasses and heads pending test results and falsified corporate books and records to conceal their malfeasance. Such actions, to the extent an obex sample tested positive (fortunately, none did), could have jeopardized the USDA’s ability to identify the diseased animal and pinpoint its place of origin. On Wednesday, February 14, 2007, Farm Fresh Meats and Farabee pleaded guilty to stealing government funds and using the mails and wires to effect the scheme. According to their guilty pleas:
(a) Farm Fresh Meats collected, and Farabee directed others to collect, obex samples from cattle outside the Targeted Cattle Population, which were not subject to payment by the USDA;
(b) Farm Fresh Meats2 and Farabee caused to be submitted payment requests to the USDA knowing that the requests were based on obex samples that were not subject to payment under the USDA Agreement; (c) Farm Fresh Meats completed and submitted, and Farabee directed others to complete and submit, BSE Surveillance Data Collection Forms to the USDA’s testing laboratory that were false and misleading;
(d) Farm Fresh Meats completed and submitted, and Farabee directed others to complete and submit, BSE Surveillance Submission Forms filed with the USDA that were false and misleading;
(e) Farm Fresh Meats falsified, and Farabee directed others to falsify, internal Farm Fresh Meats documents to conceal the fact that Farm Fresh Meats was seeking and obtaining payment from the USDA for obex samples obtained from cattle outside the Targeted Cattle Population; and
(f) Farm Fresh Meats failed to comply with, and Farabee directed others to fail to comply with, the USDA Agreement by discarding cattle carcasses and heads prior to receiving BSE test results.
A conviction for theft of government funds carries a maximum penalty of 10 years imprisonment. Mail fraud and wire fraud convictions carry a maximum penalty of 20 years imprisonment. Convictions for the above referenced violations also carry a maximum fine of $250,000 for individuals and $500,000 for organizations. In determining an actual sentence, Judge Earl H. Carroll will consult the U.S. Sentencing Guidelines, which provide appropriate sentencing ranges. The judge, however, is not bound by those guidelines in determining a sentence. Sentencing is set before Judge Earl H. Carroll on May 14, 2007. The investigation in this case was conducted by Assistant Special Agent in Charge Alejandro Quintero, United States Department of Agriculture, Office of Inspector General. The prosecution is being handled by Robert Long, Assistant U.S. Attorney, District of Arizona, Phoenix.
CASE NUMBER: CR-07-00160-PHX-EHC RELEASE NUMBER: 2007-051(Farabee) # # #
http://www.usdoj.gov/usao/az/press_releases/2007/2007-051(Farabee).pdf
how many others were doing this ???
National Veterinary Services Laboratory (NVSL) Immunohistochemistry (IHC) Testing Summary
The BSE enhanced surveillance program involves the use of a rapid screening test, followed by confirmatory testing for any samples that come back "inconclusive." The weekly summary below captures all rapid tests conducted as part of the enhanced surveillance effort. It should be noted that since the enhanced surveillance program began, USDA has also conducted approximately 9,200 routine IHC tests on samples that did not first undergo rapid testing. This was done to ensure that samples inappropriate for the rapid screen test were still tested, and also to monitor and improve upon IHC testing protocols. Of those 9,200 routine tests, one test returned a non-definitive result on July 27, 2005. That sample underwent additional testing at NVSL, as well as at the Veterinary Laboratories Agency in Weybridge, England, and results were negative. To view the IHC testing numbers from 1990 through 2004, click on the following link:
http://www.aphis.usda.gov/lpa/issues/bse/surveillance/figure2f.html
http://www.aphis.usda.gov/lpa/issues/bse_testing/test_results.html
BSE test options were limited
USDA: In 9,200 cases only one type of test could be used
WASHINGTON (AP)--The U.S. Department of Agriculture acknowledged Aug. 17 that its testing options for bovine spongiform encephalopathy were limited in 9,200 cases despite its effort to expand surveillance throughout the U.S. herd.
In those cases, only one type of test was used--one that failed to detect the disease in an infected Texas cow.
The department posted the information on its website because of an inquiry from The Associated Press.
Conducted over the past 14 months, the tests have not been included in the department's running tally of BSE tests since last summer. That total reached 439,126 on Aug. 17.
"There's no secret program," the department's chief veterinarian, John Clifford, said in an interview. "There has been no hiding, I can assure you of that."
Officials intended to report the tests later in an annual report, Clifford said.
These 9,200 cases were different because brain tissue samples were preserved with formalin, which makes them suitable for only one type of test--immunohistochemistry, or IHC.
In the Texas case, officials had declared the cow free of disease in November after an IHC test came back negative. The department's inspector general ordered an additional kind of test, which confirmed the animal was infected.
Veterinarians in remote locations have used the preservative on tissue to keep it from degrading on its way to the department's laboratory in Ames, Iowa. Officials this year asked veterinarians to stop using preservative and send fresh or chilled samples within 48 hours.
The department recently investigated a possible case of BSE that turned up in a preserved sample. Further testing ruled out the disease two weeks ago.
Scientists used two additional tests--rapid screening and Western blot--to help detect BSE in the country's second confirmed case, in a Texas cow in June. They used IHC and Western blot to confirm the first case, in a Washington state cow in December 2003.
"The IHC test is still an excellent test," Clifford said. "These are not simple tests, either."
Clifford pointed out that scientists reran the IHC several times and got conflicting results. That happened, too, with the Western blot test. Both tests are accepted by international animal health officials.
Date: 8/25/05
http://www.hpj.com/archives/2005/aug05/aug29/BSEtestoptionswerelimited.cfm
-------- Original Message -------- Subject: USA BIO-RADs INCONCLUSIVEs Date: Fri, 17 Dec 2004 15:37:28 -0600 From: "Terry S. Singeltary Sr." To: susan_berg@bio-rad.com
Hello Susan and Bio-Rad,
Happy Holidays!
I wish to ask a question about Bio-Rad and USDA BSE/TSE testing and there inconclusive. IS the Bio-Rad test for BSE/TSE that complicated, or is there most likely some human error we are seeing here?
HOW can Japan have 2 positive cows with No clinical signs WB+, IHC-, HP- , BUT in the USA, these cows are considered 'negative'?
IS there more politics working here than science in the USA?
What am I missing?
-------- Original Message -------- Subject: Re: USDA: More mad cow testing will demonstrate beef's safety Date: Fri, 17 Dec 2004 09:26:19 -0600 From: "Terry S. Singeltary Sr." snip...end
Experts doubt USDA's mad cow results
snip...END
WELL, someone did call me from Bio-Rad about this, however it was not Susan Berg. but i had to just about take a blood oath not to reveal there name. IN fact they did not want me to even mention this, but i feel it is much much to important. I have omitted any I.D. of this person, but thought I must document this ;
Bio-Rad, TSS phone conversation 12/28/04
Finally spoke with ;
Bio-Rad Laboratories 2000 Alfred Nobel Drive Hercules, CA 94547 Ph: 510-741-6720 Fax: 510-741-5630 Email: XXXXXXXXXXXXXXXXXX
at approx. 14:00 hours 12/28/04, I had a very pleasant phone conversation with XXXX XXXXX about the USDA and the inconclusive BSE testing problems they seem to keep having. X was very very cautious as to speak directly about USDA and it's policy of not using WB. X was very concerned as a Bio-Rad official of retaliation of some sort. X would only speak of what other countries do, and that i should take that as an answer. I told X I understood that it was a very loaded question and X agreed several times over and even said a political one.
my question;
Does Bio-Rad believe USDA's final determination of False positive, without WB, and considering the new atypical TSEs not showing positive with -IHC and -HP ???
ask if i was a reporter. i said no, i was with CJD Watch and that i had lost my mother to hvCJD. X did not want any of this recorded or repeated.
again, very nervous, will not answer directly about USDA for fear of retaliation, but again said X tell me what other countries are doing and finding, and that i should take it from there. "very difficult to answer"
"very political"
"very loaded question"
outside USA and Canada, they use many different confirmatory tech. in house WB, SAF, along with IHC, HP, several times etc. you should see at several talks meetings (TSE) of late Paris Dec 2, that IHC- DOES NOT MEAN IT IS NEGATIVE. again, look what the rest of the world is doing. said something about Dr. Houston stating; any screening assay, always a chance for human error. but with so many errors (i am assuming X meant inconclusive), why are there no investigations, just false positives? said something about ''just look at the sheep that tested IHC- but were positive''. ...
TSS
-------- Original Message -------- Subject: Your questions Date: Mon, 27 Dec 2004 15:58:11 -0800 From: To: flounder@wt.net
Hi Terry:
............................................snip Let me know your phone number so I can talk to you about the Bio-Rad BSE test. Thank you
Regards
Bio-Rad Laboratories 2000 Alfred Nobel Drive Hercules, CA 94547 Ph: 510-741-6720 Fax: 510-741-5630 Email: =================================
END...TSS
######### https://listserv.kaliv.uni-karlsruhe.de/warc/bse-l.html ##########
Executive Summary
In June 2005, an inconclusive bovine spongiform encephalopathy (BSE) sample from November 2004, that had originally been classified as negative on the immunohistochemistry test, was confirmed positive on SAF immunoblot (Western blot). The U.S. Department of Agriculture (USDA) identified the herd of origin for the index cow in Texas; that identification was confirmed by DNA analysis. USDA, in close cooperation with the Texas Animal Health Commission (TAHC), established an incident command post (ICP) and began response activities according to USDA’s BSE Response Plan of September 2004. Response personnel removed at-risk cattle and cattle of interest (COI) from the index herd, euthanized them, and tested them for BSE; all were negative. USDA and the State extensively traced all at-risk cattle and COI that left the index herd. The majority of these animals entered rendering and/or slaughter channels well before the investigation began. USDA’s response to the Texas finding was thorough and effective.
http://www.aphis.usda.gov/lpa/issues/bse/epi-updates/bse_final_epidemiology_report.pdf
Report on Food & Drug Administration Dallas District Investigation of Bovine Spongiform Encephalopathy Event in Texas 2005
Executive Summary:
On June 24, 2005, USDA informed FDA that a cow in Texas tested positive for Bovine Spongiform Encephalopathy (BSE). Information provided by APHIS was that the BSE positive cow was born and raised in a herd in Texas and was approximately 12 years old. The animal was sampled for BSE at a pet food plant in Texas on November 15, 2004, as part of USDA’s enhanced surveillance program.
http://www.fda.gov/cvm/texasfeedrpt.htm
Texas even had a 'secret' test that showed that mad cow positive;
experimental IHC test results, because the test was
not a validated procedure, and because the two
approved IHC tests came back negative, the results
were not considered to be of regulatory significance
and therefore were not reported beyond the
laboratory.
• A Western blot test conducted the week of
June 5, 2005, returned positive for BSE.
http://www.usda.gov/documents/vs_bse_ihctestvar.pdf
48 hr BSE confirmation turnaround took 7+ months to confirm this case, so the BSE MRR policy could be put into place. ...TSS
THIS highly suspect stumbling and staggering Texas Mad Cow got not test at all, went straight to render ;
FOR IMMEDIATE RELEASE Statement May 4, 2004 Media Inquiries: 301-827-6242 Consumer Inquiries: 888-INFO-FDA
Statement on Texas Cow With Central Nervous System Symptoms On Friday, April 30 th , the Food and Drug Administration learned that a cow with central nervous system symptoms had been killed and shipped to a processor for rendering into animal protein for use in animal feed.
FDA, which is responsible for the safety of animal feed, immediately began an investigation. On Friday and throughout the weekend, FDA investigators inspected the slaughterhouse, the rendering facility, the farm where the animal came from, and the processor that initially received the cow from the slaughterhouse.
FDA's investigation showed that the animal in question had already been rendered into "meat and bone meal" (a type of protein animal feed). Over the weekend FDA was able to track down all the implicated material. That material is being held by the firm, which is cooperating fully with FDA.
Cattle with central nervous system symptoms are of particular interest because cattle with bovine spongiform encephalopathy or BSE, also known as "mad cow disease," can exhibit such symptoms. In this case, there is no way now to test for BSE. But even if the cow had BSE, FDA's animal feed rule would prohibit the feeding of its rendered protein to other ruminant animals (e.g., cows, goats, sheep, bison).
FDA is sending a letter to the firm summarizing its findings and informing the firm that FDA will not object to use of this material in swine feed only. If it is not used in swine feed, this material will be destroyed. Pigs have been shown not to be susceptible to BSE. If the firm agrees to use the material for swine feed only, FDA will track the material all the way through the supply chain from the processor to the farm to ensure that the feed is properly monitored and used only as feed for pigs.
To protect the U.S. against BSE, FDA works to keep certain mammalian protein out of animal feed for cattle and other ruminant animals. FDA established its animal feed rule in 1997 after the BSE epidemic in the U.K. showed that the disease spreads by feeding infected ruminant protein to cattle.
Under the current regulation, the material from this Texas cow is not allowed in feed for cattle or other ruminant animals. FDA's action specifying that the material go only into swine feed means also that it will not be fed to poultry.
FDA is committed to protecting the U.S. from BSE and collaborates closely with the U.S. Department of Agriculture on all BSE issues. The animal feed rule provides crucial protection against the spread of BSE, but it is only one of several such firewalls. FDA will soon be improving the animal feed rule, to make this strong system even stronger.
####
http://www.fda.gov/bbs/topics/news/2004/NEW01061.html
r i g h t ?
10,000,000+ LBS. of PROHIBITED BANNED MAD COW FEED I.E. MBM IN COMMERCE USA 2007
Date: March 21, 2007 at 2:27 pm PST
RECALLS AND FIELD CORRECTIONS: VETERINARY MEDICINES -- CLASS II ___________________________________
PRODUCT
Bulk cattle feed made with recalled Darling’s 85% Blood Meal, Flash Dried, Recall # V-024-2007 CODE Cattle feed delivered between 01/12/2007 and 01/26/2007
RECALLING FIRM/MANUFACTURER
Pfeiffer, Arno, Inc, Greenbush, WI. by conversation on February 5, 2007. Firm initiated recall is ongoing.
REASON
Blood meal used to make cattle feed was recalled because it was cross-contaminated with prohibited bovine meat and bone meal that had been manufactured on common equipment and labeling did not bear cautionary BSE statement.
VOLUME OF PRODUCT IN COMMERCE
42,090 lbs. DISTRIBUTION WI
___________________________________
PRODUCT
Custom dairy premix products: MNM ALL PURPOSE Pellet, HILLSIDE/CDL Prot-Buffer Meal, LEE, M.-CLOSE UP PX Pellet, HIGH DESERT/ GHC LACT Meal, TATARKA, M CUST PROT Meal, SUNRIDGE/CDL PROTEIN Blend, LOURENZO, K PVM DAIRY Meal, DOUBLE B DAIRY/GHC LAC Mineral, WEST PIONT/GHC CLOSEUP Mineral, WEST POINT/GHC LACT Meal, JENKS, J/COMPASS PROTEIN Meal, COPPINI – 8# SPECIAL DAIRY Mix, GULICK, L-LACT Meal (Bulk), TRIPLE J – PROTEIN/LACTATION, ROCK CREEK/GHC MILK Mineral, BETTENCOURT/GHC S.SIDE MK-MN, BETTENCOURT #1/GHC MILK MINR, V&C DAIRY/GHC LACT Meal, VEENSTRA, F/GHC LACT Meal, SMUTNY, A-BYPASS ML W/SMARTA, Recall # V-025-2007 CODE The firm does not utilize a code - only shipping documentation with commodity and weights identified.
RECALLING FIRM/MANUFACTURER
Rangen, Inc, Buhl, ID, by letters on February 13 and 14, 2007. Firm initiated recall is complete. REASON Products manufactured from bulk feed containing blood meal that was cross contaminated with prohibited meat and bone meal and the labeling did not bear cautionary BSE statement.
VOLUME OF PRODUCT IN COMMERCE
9,997,976 lbs.
DISTRIBUTION ID and NV
END OF ENFORCEMENT REPORT FOR MARCH 21, 2007
http://www.fda.gov/bbs/topics/enforce/2007/ENF00996.html
OR THE OTHER BSE INCONCLUSIVE THAT SAT ON A SHELF FOR 4 MONTHS WHILE THE USDA BSE MRR POLICY WAS PUT IN MOTION, simply because this guy forgets to send sample in, ooops ;
"I would note that the sample was taken in April, at which time the protocols allowed for a preservative to be used. The sample was not submitted to us until last week because the veterinarian set aside the sample after preserving it and simply forgot to send it in.
http://www.usda.gov/wps/portal/usdahome?contentidonly=true&contentid=2005/07/0280.xml
THE TEXAS GONZALES/PURINA INCIDENT SHOWED THAT 5.5 GRAMS OF RUMINANT PROTEIN WAS FED TO CATTLE ;
FOR IMMEDIATE RELEASE P01-05 January 30, 2001 Print Media: 301-827-6242 Broadcast Media: 301-827-3434 Consumer Inquiries: 888-INFO-FDA
FDA ANNOUNCES TEST RESULTS FROM TEXAS FEED LOT
Today the Food and Drug Administration announced the results of tests taken on feed used at a Texas feedlot that was suspected of containing meat and bone meal from other domestic cattle -- a violation of FDA's 1997 prohibition on using ruminant material in feed for other ruminants. Results indicate that a very low level of prohibited material was found in the feed fed to cattle.
FDA has determined that each animal could have consumed, at most and in total, five-and-one-half grams - approximately a quarter ounce -- of prohibited material. These animals weigh approximately 600 pounds.
It is important to note that the prohibited material was domestic in origin (therefore not likely to contain infected material because there is no evidence of BSE in U.S. cattle), fed at a very low level, and fed only once. The potential risk of BSE to such cattle is therefore exceedingly low, even if the feed were contaminated.
According to Dr. Bernard Schwetz, FDA's Acting Principal Deputy Commissioner, "The challenge to regulators and industry is to keep this disease out of the United States. One important defense is to prohibit the use of any ruminant animal materials in feed for other ruminant animals. Combined with other steps, like U.S. Department of Agriculture's (USDA) ban on the importation of live ruminant animals from affected countries, these steps represent a series of protections, to keep American cattle free of BSE."
Despite this negligible risk, Purina Mills, Inc., is nonetheless announcing that it is voluntarily purchasing all 1,222 of the animals held in Texas and mistakenly fed the animal feed containing the prohibited material. Therefore, meat from those animals will not enter the human food supply. FDA believes any cattle that did not consume feed containing the prohibited material are unaffected by this incident, and should be handled in the beef supply clearance process as usual.
FDA believes that Purina Mills has behaved responsibly by first reporting the human error that resulted in the misformulation of the animal feed supplement and then by working closely with State and Federal authorities.
This episode indicates that the multi-layered safeguard system put into place is essential for protecting the food supply and that continued vigilance needs to be taken, by all concerned, to ensure these rules are followed routinely.
FDA will continue working with USDA as well as State and local officials to ensure that companies and individuals comply with all laws and regulations designed to protect the U.S. food supply.
http://www.fda.gov/bbs/topics/NEWS/2001/NEW00752.html
P04.27
Experimental BSE Infection of Non-human Primates: Efficacy of the Oral Route
Holznagel, E1; Yutzy, B1; Deslys, J-P2; Lasmézas, C2; Pocchiari, M3;Ingrosso, L3;Bierke, P4; Schulz-Schaeffer, W5; Motzkus, D6; Hunsmann, G6; Löwer, J11Paul-Ehrlich-Institut, Germany;2Commissariat à l´Energie Atomique, France;3Instituto Superiore di Sanità, Italy;4Swedish Institute for Infectious Disease control, Sweden;5Georg August University, Germany;6German Primate Center, Germany
Background:
In 2001, a study was initiated in primates to assess the risk for humans to contract BSE through contaminated food. For this purpose, BSE brain was titrated in cynomolgus monkeys.
Aims:
The primary objective is the determination of the minimal infectious dose (MID50) for oral exposure to BSE in a simian model, and, by in doing this, to assess the risk for humans.
Secondly, we aimed at examining the course of the disease to identify possible biomarkers.
Methods:
Groups with six monkeys each were orally dosed with lowering amounts of BSE brain: 16g, 5g, 0.5g, 0.05g, and 0.005g. In a second titration study, animals were intracerebrally (i.c.) dosed (50, 5, 0.5, 0.05, and 0.005 mg).
Results:
In an ongoing study, a considerable number of high-dosed macaques already developed simian vCJD upon oral or intracerebral exposure or are at the onset of the clinical phase. However, there are differences in the clinical course between orally and intracerebrally infected animals that may influence the detection of biomarkers.
Conclusions:
Simian vCJD can be easily triggered in cynomolgus monkeys on the oral route using less than 5 g BSE brain homogenate. The difference in the incubation period between 5 g oral and 5 mg i.c. is only 1 year (5 years versus 4 years). However, there are rapid progressors among orally dosed monkeys that develop simian vCJD as fast as intracerebrally inoculated animals. The work referenced was performed in partial fulfilment of the study "BSE in primates" supported by the EU (QLK1-2002-01096).
http://www.prion2007.com/pdf/Prion%20Book%20of%20Abstracts.pdf
From: TSS (216-119-144-34.ipset24.wt.net) Subject: 1 in 2 CHANCE OF GETTING BSE AKA MAD COW BY THE ORAL ROUTE (PRIMATE STUDY) Date: January 27, 2005 at 7:03 am PST
Risk of oral infection with bovine spongiform encephalopathy agent in primates
Corinne Ida Lasmézas, Emmanuel Comoy, Stephen Hawkins, Christian Herzog, Franck Mouthon, Timm Konold, Frédéric Auvré, Evelyne Correia, Nathalie Lescoutra-Etchegaray, Nicole Salès, Gerald Wells, Paul Brown, Jean-Philippe Deslys Summary The uncertain extent of human exposure to bovine spongiform encephalopathy (BSE)--which can lead to variant Creutzfeldt-Jakob disease (vCJD)--is compounded by incomplete knowledge about the efficiency of oral infection and the magnitude of any bovine-to-human biological barrier to transmission. We therefore investigated oral transmission of BSE to non-human primates. We gave two macaques a 5 g oral dose of brain homogenate from a BSE-infected cow. One macaque developed vCJD-like neurological disease 60 months after exposure, whereas the other remained free of disease at 76 months. On the basis of these findings and data from other studies, we made a preliminary estimate of the food exposure risk for man, which provides additional assurance that existing public health measures can prevent transmission of BSE to man.
BSE bovine brain inoculum
100 g 10 g 5 g 1 g 100 mg 10 mg 1 mg 0·1 mg 0·01 mg
Primate (oral route)* 1/2 (50%)
Cattle (oral route)* 10/10 (100%) 7/9 (78%) 7/10 (70%) 3/15 (20%) 1/15 (7%) 1/15 (7%)
RIII mice (ic ip route)* 17/18 (94%) 15/17 (88%) 1/14 (7%)
PrPres biochemical detection
The comparison is made on the basis of calibration of the bovine inoculum used in our study with primates against a bovine brain inoculum with a similar PrPres concentration that was
inoculated into mice and cattle.8 *Data are number of animals positive/number of animals surviving at the time of clinical onset of disease in the first positive animal (%). The accuracy of
bioassays is generally judged to be about plus or minus 1 log. ic ip=intracerebral and intraperitoneal.
Table 1: Comparison of transmission rates in primates and cattle infected orally with similar BSE brain inocula
Published online January 27, 2005
http://www.thelancet.com/journal/journal.isa
It is clear that the designing scientists must
also have shared Mr Bradley’s surprise at the results because all the dose
levels right down to 1 gram triggered infection.
http://www.bseinquiry.gov.uk/files/ws/s145d.pdf
6. It also appears to me that Mr Bradley’s answer (that it would take less than say 100 grams) was probably given with the benefit of hindsight; particularly if one considers that later in the same answer Mr Bradley expresses his surprise that it could take as little of 1 gram of brain to cause BSE by the oral route within the same species. This information did not become available until the "attack rate" experiment had been completed in 1995/96. This was a titration experiment designed to ascertain the infective dose. A range of dosages was used to ensure that the actual result was within both a lower and an upper limit within the study and the designing scientists would not have expected all the dose levels to trigger infection. The dose ranges chosen by the most informed scientists at that time ranged from 1 gram to three times one hundred grams. It is clear that the designing scientists must have also shared Mr Bradley’s surprise at the results because all the dose levels right down to 1 gram triggered infection.
http://www.bseinquiry.gov.uk/files/ws/s147f.pdf
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.
According to the Procedure Manual for BSE Surveillance, dated October 2004, the target population includes:
Central nervous system (CNS) signs and/or rabies negative - sample animals of any age (emphasis added):
a. Diagnostic laboratories –samples submitted due to evidence of CNS clinical signs.
Rabies Negative Samples
USDA/OIG-A/50601-10-KC Page 19 USDA/OIG-A/50601-10-KC Page 20
b. Public health laboratories – rabies negative cases.
c. Slaughter facilities – CNS ante mortem condemned at slaughter, sampled by FSIS.
d. On-the-farm – CNS cattle that do not meet the criteria for a foreign animal disease investigation.
For FYs 2002, 2003, and 2004 (through February 2004), NVSL received 170, 133, and 45 rabies-negative samples, respectively. Between June 1, 2004, and May 29, 2005, the number of samples received for testing increased to 226 rabies suspect samples. The collection sites submitting these samples follow.
Number of Rabies Suspect Submissions *
Slaughter Plant 0
Renderer 2
On-Farm 11
Public Health Lab 94
Diagnostic Lab 81
3D-4D 8
Other 4
Collection Site
Total
200
* 26 were tested but not counted by APHIS towards meeting the target goals because the obex was not submitted.
We obtained a copy of a memorandum, dated July 13, 2004, that APHIS sent to diagnostic and public health laboratories providing them instructions on submitting samples for cattle showing signs of CNS diseases, but testing negative for rabies. The letter was sent to about 170 State veterinary diagnostic and public health laboratories and discussed the need to submit specimens to NVSL of all adult cattle (emphasis added) that showed signs of CNS diseases, but tested negative for rabies. This directive did not specify the age of the cattle. The Procedure Manual for BSE Surveillance, dated October 2004, specified samples of cattle of any age should be submitted.
We contacted laboratories in six States to determine if it was standard procedure to submit all negative rabies samples to NVSL. We found that, because of the lack of specificity in the APHIS letter and inadequate followup by APHIS, there were inconsistencies in the age of cattle samples submitted for BSE testing. For those States contacted, the following samples were submitted versus tested as negative for rabies.
USDA/OIG-A/50601-10-KC Page 21
Rabies Negative Tests Not Sent for BSE Testing Since June 1, 2004 State Negative Rabies Tests
Not Sent for BSE Testing Pennsylvania a/
15 18 Kansas b/
69 16 Wisconsin c/
1 11 South Dakota d/
0 7 Arizona e/
5 0 Mississippi e/
4 0 Total
Sent for BSE Testing
33
85
12
7
5
4
146
94
52
a/ A Pennsylvania laboratory official said only rabies negative cattle over 20 months of age were submitted for BSE testing. The laboratory did not submit 18 samples for BSE testing because the animals were less than 20 months of age.
b/ Kansas laboratory officials said early in the expanded surveillance program, there was confusion as to the cattle ages that should be submitted for BSE testing. They did not know if cattle should be submitted that were above 20 months or 30 months of age. Of the 16 animals not submitted for BSE testing, 14 were under 20 months of age from early in the expanded surveillance program. The other two animals were not tested due to internal laboratory issues. The Kansas and Nebraska area office officials contacted the laboratory and told the officials to submit rabies negative cattle of any age for BSE testing. The laboratory now submits all rabies negative cattle for BSE testing.
c/ A Wisconsin laboratory official said only rabies negative cattle samples 30 months of age or older are submitted for BSE testing. Of the 11 animals not submitted for BSE testing, 8 were less than 30 months of age. Wisconsin laboratory officials were not certain why the other three samples were not submitted.
d/ Laboratory officials from South Dakota said they did not receive notification from APHIS regarding the submission of rabies negative cases for BSE testing. The section supervisor and laboratory director were not aware of any letter sent to the laboratory. The section supervisor said most bovine rabies tests at the laboratory are performed on calves. We confirmed the laboratory’s address matched the address on APHIS’ letter distribution list. However, there was no evidence that the South Dakota area office contacted the laboratory. The laboratory was not listed on the documentation from the APHIS regional office detailing the area office contacts with laboratory personnel. We contacted the South Dakota area office and were advised that while some contact had been made with the laboratory, the contact may have involved Brucellosis rather than BSE. On May 4, 2005, the area office
33 Report from the Secretary’s Advisory Committee on Foreign Animal and Poultry Diseases, February 13, 2004.
advised us they recently contacted the laboratory regarding the submission of rabies negative samples for BSE testing.
e/ Arizona and Mississippi laboratory officials said they submitted all rabies negative samples for BSE testing regardless of the age of the animal.
An NVSL official stated that APHIS is not concerned with rabies negatives samples from cattle less than 30 months of age. This position, however, is contrary to APHIS’ published target population.
Our prior audit recognized the significant challenge for APHIS to obtain samples from some high-risk populations because of the inherent problems with obtaining voluntary compliance and transporting the carcasses for testing. USDA issued rules to prohibit nonambulatory animals (downers) from entering the food supply at inspected slaughterhouses. OIG recommended, and the International Review Subcommittee33 emphasized, that USDA should take additional steps to assure that facilitated pathways exist for dead and nonambulatory cattle to allow for the collection of samples and proper disposal of carcasses. Between June 1, 2004, and May 31, 2005, the APHIS database documents 27,617 samples were collected showing a reason for submission of nonambulatory and 325,225 samples were collected with reason of submission showing "dead."
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
USDA/OIG-A/50601-10-KC Page 22 USDA/OIG-A/50601-10-KC Page 23
34 FSIS regulations do not specifically address the designation of an establishment’s "official" boundaries; however, FSIS Notices 29-04 (dated May 27, 2004) and 40-04 (dated July 29, 2004) make it clear that FSIS inspection staff are not responsible for sampling dead cattle that are not part of the "official" premises.
35 APHIS’ area office personnel stated that it was their understanding that some establishments in the State were not presenting cattle that died or were down on the transport vehicle to FSIS for ante mortem inspection. The dead and down cattle were left in the vehicle, if possible. In rare circumstances, dead cattle may be removed from the trailer by plant personnel to facilitate the unloading of other animals.
36 A May 20, 2004, Memorandum between the Administrators of APHIS and FSIS.
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."
USDA/OIG-A/50601-10-KC Page 24
37 FSIS Notice 40-04, dated July 29, 2004.
38 FSIS Notice 29-04, dated May 27, 2004.
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."
We obtained 123 APHIS sampling agreements and contracts with firms and plotted their locations within the United States (see exhibit F). We also analyzed the samples tested to the BSE sampling goals allocated to each State under the prior surveillance program. This analysis showed that there are
USDA/OIG-A/50601-10-KC Page 26
39APHIS noted that sites with agreements do not necessarily reflect the entire universe of collection sites and at some sites APHIS collects samples with no payment involved and no agreement in place. OIG agrees that not all collection sites are reflected in our presentation of the 123 sites with reimbursable agreements. OIG believes obtaining sampling agreements is one of the primary methods available to increase sample numbers in areas with sampling gaps.
sampling gaps in two large areas of the United States where APHIS did not have contracts with collection sites. These two areas are shown in the following chart (Montana, South Dakota, North Dakota and Wyoming – Group 1 and Louisiana, Oklahoma, Arkansas, and Tennessee – Group 2): State
Original Sampling Goal Based on (268,500 sampling goal)
Samples collected as of May 31, 2005
No. of BSE Sampling Agreements/ Contracts39 snip...see chart in pdf full text link. ...tss
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.
snip...
USDA Testing Protocols and Quality Assurance Procedures
In November 2004, USDA announced that its rapid screening test produced an inconclusive BSE test result. A contract laboratory ran its rapid screening test on a brain sample collected for testing and produced three high positive reactive results. As required, the contract laboratory forwarded the inconclusive sample to APHIS’ National Veterinary Services Laboratories (NVSL) for confirmation. NVSL repeated the rapid screening test, which again produced three high positive reactive results. Following established protocol, NVSL ran its confirmatory test, an immunohistochemistry (IHC) test, which was interpreted as negative for BSE.
Faced with conflicting results between the rapid screening and IHC tests, NVSL scientists recommended additional testing to resolve the discrepancy but APHIS headquarters officials concluded that no further testing was necessary since testing protocols were followed and the confirmatory test was negative. In our discussions with APHIS officials, they justified their decision to not do additional testing because the IHC test is internationally recognized as the "gold standard" of testing. Also, they believed that
USDA/OIG-A/50601-10-KC/ Page iv
conducting additional tests would undermine confidence in USDA’s testing protocols.
OIG obtained evidence that indicated additional testing was prudent. We came to this conclusion because the rapid screening tests produced six high positive reactive results, the IHC tests conflicted, and various standard operating procedures were not followed. Also, our review of the relevant scientific literature, other countries’ protocols, and discussions with experts led us to conclude that additional confirmatory testing should be considered in the event of conflicting test results.
To maintain objectivity and independence, we requested that USDA’s Agricultural Research Service (ARS) perform the Office International des Epizooties (OIE) Scrapie-Associated Fibrils (SAF) immunoblot test. The additional testing produced positive results. To confirm, the Secretary of Agriculture requested that an internationally recognized BSE laboratory in Weybridge, England (Weybridge) perform additional testing. Weybridge conducted various tests, including their own IHC tests and three Western blot tests. The tests confirmed that the cow was infected with BSE. The Secretary immediately directed USDA scientists to work with international experts to develop new protocols that include performing dual confirmatory tests in the event of an inconclusive BSE screening test.
We attribute the failure to identify the BSE positive sample to rigid protocols, as well as the lack of adequate quality assurance controls over its testing program. Details of our concerns are discussed in Findings 3 and 4.
snip...
Section 2. Testing Protocols and Quality Assurance Controls In November 2004, USDA announced that its rapid screening test, Bio-Rad Enzyme Linked Immunosorbent Assay (ELISA), produced an inconclusive BSE test result as part of its enhanced BSE surveillance program. The ELISA rapid screening test performed at a BSE contract laboratory produced three high positive reactive results.40 As required,41 the contract laboratory forwarded the inconclusive sample to the APHIS National Veterinary Services Laboratories (NVSL) for confirmatory testing. NVSL repeated the ELISA testing and again produced three high positive reactive results.42 In accordance with its established protocol, NVSL ran its confirmatory test, an immunohistochemistry (IHC) test, which was interpreted as negative for BSE. In addition, NVSL performed a histological43 examination of the tissue and did not detect lesions44 consistent with BSE. Faced with conflicting results, NVSL scientists recommended additional testing to resolve the discrepancy but APHIS headquarters officials concluded no further testing was necessary because testing protocols were followed. In our discussions with APHIS officials, they justified their decision not to do additional testing because the IHC is internationally recognized as the “gold standard.” Also, they believed that conducting additional tests would undermine confidence in USDA’s established testing protocols. However, OIG obtained evidence that indicated additional testing was prudent to ensure that USDA’s testing protocols were effective in detecting BSE and that confidence in USDA’s testing procedures was maintained. OIG came to this conclusion because the rapid tests produced six high positive reactive results, confirmatory testing conflicted with the rapid test results, and various standard operating procedures were not followed. Also, our review of scientific literature, other country protocols, as well as discussions with internationally recognized experts led us to conclude that confirmatory testing should not be limited when conflicting test results are obtained. To maintain objectivity and independence in our assessment, we requested the USDA Agricultural Research Service (ARS) perform the Office International des Epizooties (OIE) Scrapie-Associated Fibrils (SAF) 40 ELISA test procedures require two additional (duplicate) tests if the initial test is reactive, before final interpretation. If either of the duplicate tests is reactive, the test is deemed inconclusive. 41 Protocol for BSE Contract Laboratories to Receive and Test Bovine Brain Samples and Report Results for BSE Surveillance Standard Operating Procedure (SOP), dated October 26, 2004. 42 The NVSL conducted an ELISA test on the original material tested at the contract laboratory and on two new cuts from the sample tissue. 43 A visual examination of brain tissue by a microscope. 44 A localized pathological change in a bodily organ or tissue.
immunoblot.45 ARS performed the test at the National Animal Disease Center because NVSL did not have the necessary equipment46 (ultracentrifuge) to do the test. APHIS scientists observed and participated, as appropriate, in this effort. The additional tests conducted by ARS produced positive results. To confirm this finding, the Secretary requested the internationally recognized BSE reference laboratory in Weybridge, England, (Weybridge) to perform additional confirmatory testing. Weybridge conducted various tests, including their own IHC methods, as well as three Western blot methods. The tests confirmed that the suspect cow was infected with BSE. Also, Weybridge confirmed this case as an unequivocal positive case of BSE on the basis of IHC. As a result of this finding, the Secretary immediately directed USDA scientists to work with international experts to develop a new protocol that includes performing dual confirmatory tests in the event of another inconclusive BSE screening test. Finding 3 Rigid Protocols Reduced the Likelihood BSE Could be Detected APHIS relied on a single test method, as well as a histological examination of tissue for lesions consistent with BSE, to confirm the presence of BSE even though discrepant test results indicated further testing may be prudent. When IHC test results were interpreted as negative, APHIS concluded the sample tested negative for BSE. Subsequent independent tests initiated by OIG using a different testing method, as well as confirmatory testing by Weybridge, determined that the suspect sample was a positive case of BSE. APHIS Declares BSE Sample Negative Despite Conflicting Results When the tissue sample originally arrived at NVSL in November 2004 from the contract lab, NVSL scientists repeated the ELISA screening test and again produced three high positive reactive results. NVSL scientists cut out two sections of the brain sample for IHC testing. One section was used for an experimental procedure that was not part of the confirmatory testing protocol, and the other cut was for normal IHC testing using scrapie for a positive control.47 According to NVSL scientists, the experimental test results were inconclusive but the IHC test was interpreted as negative. The NVSL scientists were concerned with the inconsistencies and conducted 45 The OIE SAF immunoblot is an internationally recognized confirmatory test, often referred to as a Western blot test. There are different types of Western blots; the OIE SAF immunoblot includes enrichment steps taken with the sample prior to the standard Western blot steps. 46 APHIS has now ordered the necessary equipment for NVSL. USDA/OIG-A/50601-10-KC Page 32
47 A positive control is a sample that is known to contain a given disease or react in the test. The sample then can be used to make sure that the test for that disease works properly. In the case of BSE, tissue infected with either scrapie or BSE can serve as a positive control for an IHC test for BSE since both are different forms of the same disease (transmissible spongiform encephalopathy or TSE).
another IHC test using BSE as a positive control.48 The test result was also interpreted as negative. Also, according to the NVSL scientists, the histological examination of the tissue did not detect lesions consistent with BSE. After the second negative IHC test, NVSL scientists supported doing additional testing. They prepared a plan for additional tests; if those tests had been conducted, BSE may have been detected in the sample. The additional tests recommended by NVSL scientists, but not approved by APHIS Headquarters officials, were the IHC using other antibodies (IHC testing using different antibodies ultimately produced positive results); IHC testing of additional regions of the brain (the cerebellum tested positive); regular and enriched (OIE-like) Western blots (the obex and cerebellum tested positive); and variable rapid tests (the obex and cerebellum tested positive with two different rapid tests). NVSL officials also recommended that the sample be sent to Weybridge for confirmatory testing (to conduct IHC and OIE Western blot tests). In June 2005, Weybridge conducted IHC testing with three different antibodies, including the antibody used in the United States (tested positive), the OIE Western blot (tested positive), a modified commercial kit Western blot (negative) and the NaPTA49 Western blot (tested positive). We obtained information as to the differing protocols used by other countries. We found that while APHIS determined that additional testing was unnecessary after the IHC test, other countries have used multiple tests to confirm positives. In Japan, for example, all reactive screening test samples are examined by both IHC and a Western blot (different from the OIE SAF immunoblot). In the United Kingdom (U.K.), IHC and Western blot (different from the OIE SAF immunoblot) tests are used for all animals that test positive with a screening test. When IHC and the Western blot fail to confirm a positive rapid test, the U.K. resorts to a third test, the OIE SAF immunoblot. With these procedures in place, both Japan and the U.K. have found BSE cases that were rapid test reactive, IHC negative, and finally confirmed positive with a Western blot. Evidence Indicated Additional Testing Would Be Prudent We also spoke with an internationally recognized BSE expert regarding the advisability of limiting confirmatory testing when conflicting results are obtained. This official expressed concern about limiting confirmatory tests to the IHC despite its status as one of the “gold standard” tests. He advised that the IHC is not one test; it is a test method that can vary significantly in sensitivity from laboratory to laboratory. New antibodies can improve or
USDA/OIG-A/50601-10-KC Page 33
48 The NVSL uses scrapie as the positive control as part of its normal IHC testing procedures. Due to the conflicting results between the ELISA and IHC tests, the NVSL conducted another IHC test with BSE as the positive control. Subsequently, the NVSL modified the Confirming Inconclusive Results from BSE Testing Laboratories at the NVSL SOP to show that all IHC tested BSE inconclusive samples from contract laboratories will use BSE as the positive control. 49 Sodium phosphotungstic acid.
USDA/OIG-A/50601-10-KC Page 34
reduce sensitivity, as can variations in many of the reagents50 used. He explained that his laboratory had experienced cases where an initial confirmatory IHC test was challenged by either a more extensive IHC test or “…applying a more sensitive immunoblot.” He emphasized the importance of having additional confirmatory testing to resolve discrepant results since there are many variables, and most of the variability appears to be due to test performance of the laboratory. OIG became concerned that APHIS relied on its confirmatory test methods when rapid screening tests produced high positive reactive results six times.51 Also, we found that APHIS did not pursue and/or investigate why the ELISA produced high reactive positives. An official from the manufacturer of the ELISA test kit told us that they requested, but did not receive, information on the inconclusive reported by USDA in November 2004. These officials requested this information in order to understand the reasons for the discrepant results. The Bio-Rad ELISA rapid screening test is internationally recognized as a highly reliable test and is the rapid screening test used for USDA’s surveillance effort. According to APHIS officials, they felt it would be inappropriate to collaborate on the one sample because Bio-Rad is a USDA-APHIS regulated biologics company and only one of several competing manufacturers. To maintain confidence in USDA’s test protocols, it would have been a prudent course of action for USDA to determine why such significant differing results were obtained. The fact that they did not pursue this matter caused concerns relating to testing quality assurance procedures. In this regard, we found lack of compliance with SOPs relating to laboratory proficiency and quality assurance (see Finding 4), and, in this case, the storage of sampled material and reporting of test results. We found that the NVSL did not prepare a report to document its confirmatory testing of the November 2004 sample. The SOP52 states that the BSE network laboratory initiating the inconclusive will receive a report of the case. NVSL officials could not explain why a final report had not been prepared. We also found that the inconclusive sample was frozen prior to IHC confirmatory testing. APHIS protocols state that samples are not to be frozen prior to laboratory submission. The OIE Manual of Diagnostic Tests and Vaccines for Terrestrial Animals states that the tissues for histological or IHC examination are not to be frozen as this will provide artefactual53 lesions that may compromise the identification of vacuolation,54 and/or target site location. Although the sample was frozen, APHIS did not conduct a Western 50 A substance used in a chemical reaction to detect, measure, examine, or produce other substances. 51 The six high positive reactive results were from three tests of the submitted sample (multiple runs of the same test). 52 Confirming Inconclusive Results from Bovine Spongiform Encephalopathy Testing Laboratories at the NVSL SOP, dated August 13, 2004. 53 A structure or feature not normally present but visible as a result of an external agent or action, such as one seen in a microscopic specimen after fixation. 54 A small space or cavity in a tissue.
USDA/OIG-A/50601-10-KC Page 35
blot test on the sample. An NVSL official said freezing the sample does not make it unsuitable for IHC. APHIS determined that the sample was suitable for IHC and therefore, in accordance with its SOP, did not conduct a Western blot test. APHIS also handled the December 2003 BSE positive differently than the November 2004 sample. For the December 2003 BSE positive sample, APHIS conducted several confirmatory tests in addition to the IHC testing and histological examination (unlike the November 2004 sample tests, both of these were interpreted as positive). ARS performed two Western blots (Prionics Check Western blot and an ARS developed Western blot). When we questioned why the samples were handled differently, APHIS officials stated that the Western blots were done because the IHC in December 2003 was positive. The additional testing was done to further characterize the case, because it was the first U.S. case; the additional testing was not done to decide whether the case was positive or negative. We discussed our concerns with limiting confirmatory testing, particularly given conflicting results, with the APHIS Administrator and staff in May 2005. He explained that international standards recognized more than one “gold standard” test. In setting up its testing protocols, USDA had chosen one as the confirming test, the IHC test, and stayed with it. APHIS protocols only allow a Western blot in cases where the sample has become unsuitable for IHC tests (e.g., in cases where the brainstem architecture is not evident). International standards, he continued, accept a tissue sample as negative for BSE if its IHC test is negative. Once the test is run in accordance with protocols, additional tests undermine the USDA testing protocol and the surveillance program. He concluded that since APHIS’ protocols accepted the IHC test as confirming the presence or absence of BSE, no further testing was necessary. According to protocol, the tissue sample was determined to have tested negative for BSE. On June 24, 2005, USDA announced that the additional testing by the BSE reference laboratory in England confirmed the presence of BSE in the tissue sample. To obviate the possibility that a future sample would be declared negative and then found positive, the Secretary of Agriculture announced a change to APHIS’ testing protocols that same day. He called for “dual confirmatory tests in the event of another ‘inconclusive’ [reactive] BSE screening test.” He also indicated that he would reinforce proper procedures so that samples will not be frozen, and to spot-check the laboratories to see that they complete reports as required. APHIS issued a SOP on the new confirmatory testing protocols on November 30, 2005.
http://www.usda.gov/oig/webdocs/50601-10-KC.pdf
For the period of time from January 1, 2005, until October 15, 2005, there were 23 instances of discrepancies in results from 35 flocks. Of those 23 instances, 14 were caused by laboratory error (paperwork or sample mix-up), 3 results from field error, 5 were not completely resolved, and 1 originated from the use of a non-approved laboratory for the first test. As a result of inconsistencies, one laboratory’s certification was revoked by APHIS-VS.
http://www.usaha.org/committees/reports/2005/report-scr-2005.pdf
Suppressed PEER REVIEW of the Harvard BSE study of October 31, 2002
http://www.fsis.usda.gov/oa/topics/BSE_Peer_Review.pdf
THE SEVEN SCIENTIST REPORT ***
http://www.fda.gov/ohrms/dockets/dockets/02n0273/02n-0273-EC244-Attach-1.pdf
Subject: [Docket No. FSIS-2006-0011] FSIS Harvard Risk Assessment of Bovine Spongiform Encephalopathy (BSE)
http://www.fsis.usda.gov/OPPDE/Comments/2006-0011/2006-0011-1.pdf
[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
9/13/2005
http://www.fsis.usda.gov/OPPDE/Comments/03-025IFA/03-025IFA-2.pdf
Docket Management Docket: 02N-0273 - Substances Prohibited From Use in
Animal Food or Feed; Animal Proteins Prohibited in Ruminant Feed
Comment Number: EC -10
Accepted - Volume 2
http://www.fda.gov/ohrms/dockets/dailys/03/Jan03/012403/8004be07.html
PART 2
http://www.fda.gov/ohrms/dockets/dailys/03/Jan03/012403/8004be09.html
Date: Thu, 1 Mar 2007 14:57:20 -0600 Reply-To: Sustainable Agriculture Network Discussion Group Sender: Sustainable Agriculture Network Discussion Group From: "Terry S. Singeltary Sr." <[log in to unmask]> Subject: Re: O.I.E. SELLS THERE SOUL TO THE DEVIL AND WILL REPEAT WHAT THE U.K. DID, POISON THE WORLD LEGALLY WITH MAD COW DISEASEs
http://lists.ifas.ufl.edu/cgi-bin/wa.exe?A2=ind0703&L=sanet-mg&P=498
THE OIE has now shown they are nothing more than a National Trading Brokerage for all strains of animal TSE.
AS i said before, OIE should hang up there jock strap now, since it appears they will buckle every time a country
makes some political hay about trade protocol, commodities and futures. IF they are not going to be science based, they
should do everyone a favor and dissolve there organization. ...
Page 95 of 98
8/3/2006
WHAT ABOUT RISK FACTORS TO HUMANS FROM ALL OTHER TSEs, WITH RELATIONS TO SRMs ???
a.. BSE OIE
see full text ;
http://p079.ezboard.com/fwolftracksproductionsfrm2.showMessage?topicID=470.topic
IT'S as obvious as day and night, either Larry, Curley, and Mo have been at the helm of the
USDA/APHIS/FSIS/FDA/CDC/NIH et al for many many years, or the incompetence of these agencies are so inept,
either through ignorance and or just too overweight with industry reps., they then should be all done away with and a
single agency brought forth, and if not, how will you correct this ongoing problem ?
GWs and his sleeping partners at the OIE, gave birth to the BSE MRR policy, the legal. trading of all strains of TSE globally ...
http://www.fsis.usda.gov/OPPDE/Comments/2006-0011/2006-0011-1.pdf
http://lists.ifas.ufl.edu/cgi-bin/wa.exe?A2=ind0612&L=sanet-mg&T=0&P=20678
http://lists.ifas.ufl.edu/cgi-bin/wa.exe?A2=ind0611&L=sanet-mg&T=0&I=-3&P=3381
IN A NUT SHELL ;
(Adopted by the International Committee of the OIE on 23 May 2006)
11. Information published by the OIE is derived from appropriate declarations made by the official Veterinary Services of Member Countries. The OIE is not responsible for inaccurate publication of country disease status based on inaccurate information or changes in epidemiological status or other significant events that were not promptly reported to the Central Bureau,
http://www.oie.int/eng/Session2007/RF2006.pdf
AS I SAID, bought and paid for by your local cattle dealer i.e. USDA. The status of USA for BSE that is to be announced in May 2007 by OIE, has already been decided, and it's a big fat lie. This is like letting a known, and convicted criminal, prosecute themselves. They will find themselves innocent every time. It's a win/win situation for the industry, and the consumer cr@ps out again, snake eyes, you loose. ...
National Center for Import and Export Sanitary International Standards Team World Organization for Animal Health - (OIE)
Draft Proposals October 2006 Comments Submitted to OIE Proposed for Adoption at General Session May 2007
Draft Proposals October 2006
Bovine Spongiform Encephalopathy (pdf) (rtf)
http://www.aphis.usda.gov/NCIE/oie/pdf_files/tahc-bse-75-oct06.pdf
http://www.aphis.usda.gov/NCIE/oie/rtf_files/tahc-bse-75-oct06.rtf
Comments Submitted to OIE
Bovine Spongiform Encephalopathy (pdf) (rtf)
http://www.aphis.usda.gov/NCIE/oie/pdf_files/tahc-bse-75-oct06_cmt.pdf
http://www.aphis.usda.gov/NCIE/oie/rtf_files/tahc-bse-75-oct06_cmt.rtf
Proposed for Adoption at General Session May 2007
Bovine Spongiform Encephalopathy (pdf)
http://www.aphis.usda.gov/NCIE/oie/pdf_files/tahc-bse-75-mar07.pdf
Monthly Test Results APHIS reports ongoing surveillance totals monthly. The BSE ongoing surveillance program will sample approximately 40,000 animals each year. Under the program, USDA will continue to collect samples from a variety of sites and from the cattle populations where the disease is most likely to be detected, similar to the enhanced surveillance program procedures.
BSE Ongoing Surveillance Program Cumulative Total
From Sep 1, 2006: 46,673
Month Number of Tests
Sep 2007 3,832 Aug 2007 5,433 Jul 2007 4,267 Jun 2007 4,106 May 2007 5,217 Apr 2007 5,104 Mar 2007 4,130 Feb 2007 2,937 Jan 2007 3,075 Dec 2006 2,477 Nov 2006 2,235 Oct 2006 2,068 Sep 2006 1,792
snip...end
http://www.aphis.usda.gov/newsroom/hot_issues/bse/surveillance/ongoing_surv_results.shtml
let's see now, from a USA cattle herd of some 95 million head, the expanded 2004 BSE cover-up that suddenly halted after the finding of the 2 BASE cases i.e. atypical h-BSE documented in Alabama and Texas, this after rendering another stumbling and staggering mad cow in Texas that was suspect BSE, but _no_ test at all was given, and after suspect BSE samples sat stored on some shelf somewhere for months and months, while the OIE BSE MRR was being born, etc, etc, the USA total figures for BSE testing in this day and time, regardless of the figures the OIE recommend, are terribly flawed, to say the least. ...
Monitoring the occurrence of emerging forms of Creutzfeldt-Jakob disease inthe United States
http://cjdusa.blogspot.com/
BSE (Mad Cow) Update:Do Reports of sCJD Clusters Matter?
snip... see full text ;
http://cjdtexas.blogspot.com/
CJD QUESTIONNAIRE
http://cjdquestionnaire.blogspot.com/
SCRAPIE USA
http://scrapie-usa.blogspot.com/
NOR-98 ATYPICAL SCRAPIE CASES USA
http://nor-98.blogspot.com/
CREUTZFELDT JAKOB DISEASE MAD COW BASE UPDATE USA
http://cjdmadcowbaseoct2007.blogspot.com/
BSE BASE MAD COW TESTING TEXAS, USA, AND CANADA, A REVIEW OF SORTS
http://madcowtesting.blogspot.com/
MADCOW USDA the untold story
http://madcowusda.blogspot.com/
USA NVCJD BLOOD RECALLS ONLY ;
http://www.google.com/search?hl=en&q=CJD+BLOOD+RECALLS+TSS&btnG=Search
vCJD case study highlights blood transfusion risk
http://vcjdblood.blogspot.com/
Transmissible Mink Encephalopathy TME
http://transmissible-mink-encephalopathy.blogspot.com/
CHRONIC WASTING DISEASE
http://chronic-wasting-disease.blogspot.com/
SEAC 99th meeting on Friday 14th December 2007
http://seac992007.blogspot.com/
Terry S. Singeltary Sr. P.O. Box 42 Bacliff, Texas USA 77518
OIE BSE RECOMMENDATION FOR USA, bought and paid for by your local cattle dealers i.e. USDA
STATEMENT BY DR. RON DEHAVEN REGARDING OIE RISK RECOMMENDATION
March 9, 2007
“In October 2006, the U.S. Department of Agriculture submitted an application and supporting documents to the World Organization for Animal Health (OIE) to formally request country classification for bovine spongiform encephalopathy (BSE) risk. The OIE undertakes a thorough review process before recommending a risk classification, and then provides an opportunity for all delegate countries to review the recommendations and present comments prior to final adoption of a country’s classification at the OIE’s General Assembly meeting in May.
“While we recognize that a final classification decision will not be made by the OIE until May, we feel it is important to be responsive to questions we are now being asked about the risk classification recommended for the United States. The OIE Scientific Commission has endorsed the recommendation from an OIE expert panel that the United States be classified as “controlled risk” for BSE.
“The controlled risk classification recognizes that OIE-recommended, science-based mitigation measures are in place to effectively manage any possible risk of BSE in the cattle population. This recommendation provides strong support that U.S. regulatory controls are effective and that U.S cattle and products from cattle of all ages can be safely traded in accordance with international guidelines, due to our interlocking safeguards.
“The OIE risk classification process is an essential step in promoting trade and understanding of this disease. We appreciate OIE’s review of our application, as well as its leadership in developing sound, science-based guidelines that will help countries standardize regulations and import requirements. We look forward to the final adoption of this classification, which will be announced at the OIE meeting in May.”
# http://www.aphis.usda.gov/newsroom/content/2007/03/OIE_statement3-9-07.shtml
Sample Size Estimate for BSE Ongoing Surveillance
July 20, 2006
Purpose, rationale, and objectives of surveillance
Animal and public health concerns about bovine spongiform encephalopathy (BSE) have led to the establishment of active surveillance programs among other regulatory measures to monitor and prevent disease. Active surveillance for BSE was initiated in the United States in 1990. In response to identification of a BSE-affected imported dairy cow in December 2003, the U.S. Enhanced BSE Surveillance Program was implemented in June 2004. Through these efforts, two cases of BSE were identified through March 2006. Both cases were in beef cattle over 10 years old (born before the feed ban of 1997), one located in Texas and one in Alabama.
Based on data collected in the United States over the last 7 years, including over a half million samples from the Enhanced Surveillance program, the USDA has developed an estimate of prevalence of BSE among U.S. cattle that was extremely low, projected at less than one case per million animals in the standing adult cattle population at the 95 percent confidence level (APHIS 2006a). In addition, the USDA demonstrated that surveillance efforts to date far exceed the World Organization for Animal Health (OIE) “type A” surveillance recommendations. Prevalence is expected to decline as long as mitigation efforts that maintain low risk for introduction and spread of the BSE agent among U.S. cattle are equivalent to or better than those evaluated by the Harvard Risk Assessment (Cohen et al., 2001, 2003).
The principal purposes of ongoing BSE surveillance are:
1. To continue to monitor the BSE status of U.S. cattle.
2. To provide mechanisms for detection of BSE prevalence if it were to increase above 1 infected animal per million adults.
In addition, we aim to meet the objective of conducting ongoing surveillance at a level that meets or exceeds OIE surveillance recommendations. We believe this objective is reached by the following sampling strategy, which is sufficient to detect BSE at 1 infected animal per 1,000,000 adult cattle in the population with a high degree of confidence.
Sample Size to Meet OIE Surveillance Recommendations
APHIS is committed to maintaining BSE surveillance that at least meets OIE guidelines. The OIE surveillance guidelines for BSE recommend a target number of surveillance points for Type A surveillance based on the size of a country’s cattle population. These points are accrued over 7 consecutive years, and are weighted according to the surveillance stream and age of the animal sampled. For a large cattle population, using the design prevalence of 1 case per 100,000 adult cattle and 95 percent confidence, 300,000 total points over 7 years, or 42,857 points per year, are required for Type A surveillance (OIE 2005).
The four surveillance streams identified in the OIE Code are clinical suspects; casualty slaughter; fallen stock; and healthy slaughter. OIE guidelines recommend sampling from at least three of the four surveillance streams. BSE surveillance efforts in the United States have always focused on the three surveillance streams where BSE is more likely to be found – clinical suspects, casualty slaughter, and fallen stock. During the 7 consecutive years prior to March 17, 2006, the United States collected 735,213 BSE samples from these surveillance streams and accumulated 2,973,804 OIE points (APHIS 2006b).
As shown in the calculation below, if the ongoing surveillance plan continues similar sample numbers from these surveillance streams, approximately 10,500 cattle per year would be sufficient to meet the OIE minimum number of sample points for Type A surveillance.
2,973,804 points ÷ 735,213 samples = 4.1 points per sample and 42,857 points required per year ÷ 4.1 points per sample = 10,453 samples per year
Sample Size for BSE Prevalence Estimates
The OIE minimum number of samples as outlined would be sufficient for a design prevalence of 1 case per 100,000 adult cattle. However, in the interest of maintaining confidence in previous BSE prevalence estimates, a more sensitive design prevalence of 1 case per 1 million adult cattle will be adopted for ongoing surveillance. The BSurvE model (Wilesmith et al., 2004) can be used to help estimate the number of samples necessary to achieve this level of detection. This model determines sample point values based on a particular population’s demographics.
The point tables described by OIE surveillance guidelines were designed using the BSurvE model to represent a conservative scenario (e.g., low point value and greater number of samples) of the characteristics of the cattle populations of all of its member countries. These demographic characteristics describe a hypothetic population that culls cattle very rapidly (mean age of approximately 4 years) and results in point values that are lower than the BSurvE model would calculate for cattle in most countries. In the United States, however, demographic data indicate 25 percent of the adult cattle population of approximately 42 million are dairy production type and 75% are percent beef cattle (NASS 2005). While the U.S. dairy population undergoes rapid culling similar to the characteristics used to develop the OIE table, beef cattle generally remain in the herd to a much older age until they no longer produce calves. Because actual U.S. data are available regarding population characteristics, it is appropriate to base the sample size estimates on the points calculated through BSurvE given U.S. demographics (these points are hereafter referred to as “analytical points”). The higher average age at which beef cattle are culled influences the BSurvE output and results in substantially higher point values. Hence, sample values calculated with BSurvE from actual U.S. data result in higher point values than the conservative OIE estimates. Each analytical point calculated by BSurvE corresponds to a single nontargeted sample (Wilesmith et al., 2004).
According to OIE, BSurvE and Cannon and Roe (1982) calculations, the required number of non-targeted samples needed to detect a prevalence of 1 case per million adult cattle with 95% confidence (given a population size of 42 million adult cattle) is 3,000,000, 2,995,730, and 2,891,389, respectively. Conservatively using the value of 3 million, we calculate that we will need to accumulate 428,571 analytical points (with negative results) per year across a period of 7 years to meet this objective. 3,000,000 analytical points ÷ 7 years = 428,571 analytical points per year The prevalence analysis conducted on U.S. surveillance data collected from March, 1999 through March 2006 reports 6,745,010 points resulting from 735,213 samples. The average sample was worth 9.5 analytical points.1 6,745,010 analytic points ÷ 735,213 samples = 9.5 analytic points per sample If USDA maintained an equivalent mix of surveillance streams during ongoing surveillance, then approximately 45,113 samples per year would be required to meet this objective. 428,571 analytical points per year ÷ 9.5 analytical points per sample = 45,113 samples per year However, greater than one half million of the samples from Enhanced Surveillance were collected from fallen stock – the surveillance stream that produced the lowest point values. Sampling efforts can be focused on higher value surveillance streams – clinical suspects and casualty slaughter – with a limited number of samples obtained from the fallen stock surveillance stream. This will substantially increase the average point value per sample. Therefore, we estimate that 40,000 samples collected from these three surveillance streams – with a focus on clinical suspects and casualty slaughter - will exceed the number of points necessary to maintain confidence that prevalence is less than one infected animal per million adult cattle. Further, since the data are analyzed over 7 consecutive years, the estimate of sample size may be adjusted each year as appropriate to assure a robust prevalence estimate.
References: APHIS (Animal and Plant Health Inspection Service) (2006a). An Estimate of the Prevalence of BSE in the United States. USDA: APHIS: VS: Centers for Epidemiology and Animal Health, National Surveillance Unit. Accessed May 5, 2006, online at http://www.aphis.usda.gov/newsroom/hot_issues/bse/content/printable_version/BSEprevalenceestimate4- 26-06.pdf APHIS (Animal and Plant Health Inspection Service) (2006b). Summary of BSE Enhanced Surveillance in the United States. USDA: APHIS: VS: Centers for Epidemiology and Animal Health, National Surveillance Unit. Accessed May 5, 2006, online at http://www.aphis.usda.gov/newsroom/hot_issues/bse/content/printable_version/SummaryEnhancedBS E-Surv4-26-06.pdf Cannon RM, Roe RT (1982). Livestock Disease Surveys: A Field Manual for Veterinarians, Australian Bureau of Animal Health, Canberra. Cohen JT, Duggar K, Gray G, Kreindel S, Abdelrahman H, HabteMariam T, Oryang D, Tameru B (2001, 2003). Evaluation of the Potential for Bovine Spongiform Encephalopathy in the United States. Harvard Center for Risk Analysis/Harvard School of Public Health and Center for Computational Epidemiology, College of Veterinary Medicine, Tuskegee University. November 2001, (revised October 2003). Available at http://www.aphis.usda.gov/lpa/issues/bse/madcow.pdf. NASS (2005) Cattle, National Agricultural Statistics Service, USDA. Washington, D.C. Released January 28, 2005, by the National Agricultural Statistics Service (NASS), Agricultural Statistics Board, U.S. Department of Agriculture. Available December 15, 2005, at: http://usda.mannlib.cornell.edu/reports/nassr/livestock/pct-bb/catl0101.txt OIE (Office International des Epizooties) (2005). Appendix 3.8.4: Surveillance for bovine spongiform encephalopathy. In: Terrestrial animal health code, 14th ed., Paris, 2005. Wilesmith J, Morris R, Stevenson M, Cannon R, Prattley D, and Benard H (2004). Development of a Method for the Evaluation of National Surveillance Data and Optimization of National Surveillance Strategies for Bovine Spongiform Encephalopathy. European Union TSE Community Reference Laboratory, Veterinary Laboratories Agency, Weybridge, England.
http://www.aphis.usda.gov/peer_review/downloads/BSE_sample_size_ongoing_surv_after.pdf
does not compute. fuzzy math. full formula below. ...TSS
-MORE
Office of the United States Attorney District of Arizona
FOR IMMEDIATE RELEASE For Information Contact Public Affairs
February 16, 2007 WYN HORNBUCKLE Telephone: (602) 514-7625 Cell: (602) 525-2681
CORPORATION AND ITS PRESIDENT PLEAD GUILTY TO DEFRAUDING GOVERNMENT’S MAD COW DISEASE SURVEILLANCE PROGRAM
PHOENIX -- Farm Fresh Meats, Inc. and Roland Emerson Farabee, 55, of Maricopa, Arizona, pleaded guilty to stealing $390,000 in government funds, mail fraud and wire fraud, in federal district court in Phoenix.U.S. Attorney Daniel Knauss stated, “The integrity of the system that tests for mad cow disease relies upon the honest cooperation of enterprises like Farm Fresh Meats. Without that honest cooperation, consumers both in the U.S. and internationally are at risk. We want to thank the USDA’s Office of Inspector General for their continuing efforts to safeguard the public health and enforce the law.” Farm Fresh Meats and Farabee were charged by Information with theft of government funds, mail fraud and wire fraud. According to the Information, on June 7, 2004, Farabee, on behalf of Farm Fresh Meats, signed a contract with the U.S. Department of Agriculture (the “USDA Agreement”) to collect obex samples from cattle at high risk of mad cow disease (the “Targeted Cattle Population”). The Targeted Cattle Population consisted of the following cattle: cattle over thirty months of age; nonambulatory cattle; cattle exhibiting signs of central nervous system disorders; cattle exhibiting signs of mad cow disease; and dead cattle. Pursuant to the USDA Agreement, the USDA agreed to pay Farm Fresh Meats $150 per obex sample for collecting obex samples from cattle within the Targeted Cattle Population, and submitting the obex samples to a USDA laboratory for mad cow disease testing. Farm Fresh Meats further agreed to maintain in cold storage the sampled cattle carcasses and heads until the test results were received by Farm Fresh Meats.
Evidence uncovered during the government’s investigation established that Farm Fresh Meats and Farabee submitted samples from cattle outside the Targeted Cattle Population. Specifically, Farm Fresh Meats and Farabee submitted, or caused to be submitted, obex samples from healthy, USDA inspected cattle, in order to steal government moneys.
Evidence collected also demonstrated that Farm Fresh Meats and Farabee failed to maintain cattle carcasses and heads pending test results and falsified corporate books and records to conceal their malfeasance. Such actions, to the extent an obex sample tested positive (fortunately, none did), could have jeopardized the USDA’s ability to identify the diseased animal and pinpoint its place of origin. On Wednesday, February 14, 2007, Farm Fresh Meats and Farabee pleaded guilty to stealing government funds and using the mails and wires to effect the scheme. According to their guilty pleas:
(a) Farm Fresh Meats collected, and Farabee directed others to collect, obex samples from cattle outside the Targeted Cattle Population, which were not subject to payment by the USDA;
(b) Farm Fresh Meats2 and Farabee caused to be submitted payment requests to the USDA knowing that the requests were based on obex samples that were not subject to payment under the USDA Agreement; (c) Farm Fresh Meats completed and submitted, and Farabee directed others to complete and submit, BSE Surveillance Data Collection Forms to the USDA’s testing laboratory that were false and misleading;
(d) Farm Fresh Meats completed and submitted, and Farabee directed others to complete and submit, BSE Surveillance Submission Forms filed with the USDA that were false and misleading;
(e) Farm Fresh Meats falsified, and Farabee directed others to falsify, internal Farm Fresh Meats documents to conceal the fact that Farm Fresh Meats was seeking and obtaining payment from the USDA for obex samples obtained from cattle outside the Targeted Cattle Population; and
(f) Farm Fresh Meats failed to comply with, and Farabee directed others to fail to comply with, the USDA Agreement by discarding cattle carcasses and heads prior to receiving BSE test results.
A conviction for theft of government funds carries a maximum penalty of 10 years imprisonment. Mail fraud and wire fraud convictions carry a maximum penalty of 20 years imprisonment. Convictions for the above referenced violations also carry a maximum fine of $250,000 for individuals and $500,000 for organizations. In determining an actual sentence, Judge Earl H. Carroll will consult the U.S. Sentencing Guidelines, which provide appropriate sentencing ranges. The judge, however, is not bound by those guidelines in determining a sentence. Sentencing is set before Judge Earl H. Carroll on May 14, 2007. The investigation in this case was conducted by Assistant Special Agent in Charge Alejandro Quintero, United States Department of Agriculture, Office of Inspector General. The prosecution is being handled by Robert Long, Assistant U.S. Attorney, District of Arizona, Phoenix.
CASE NUMBER: CR-07-00160-PHX-EHC RELEASE NUMBER: 2007-051(Farabee) # # #
http://www.usdoj.gov/usao/az/press_releases/2007/2007-051(Farabee).pdf
how many others were doing this ???
National Veterinary Services Laboratory (NVSL) Immunohistochemistry (IHC) Testing Summary
The BSE enhanced surveillance program involves the use of a rapid screening test, followed by confirmatory testing for any samples that come back "inconclusive." The weekly summary below captures all rapid tests conducted as part of the enhanced surveillance effort. It should be noted that since the enhanced surveillance program began, USDA has also conducted approximately 9,200 routine IHC tests on samples that did not first undergo rapid testing. This was done to ensure that samples inappropriate for the rapid screen test were still tested, and also to monitor and improve upon IHC testing protocols. Of those 9,200 routine tests, one test returned a non-definitive result on July 27, 2005. That sample underwent additional testing at NVSL, as well as at the Veterinary Laboratories Agency in Weybridge, England, and results were negative. To view the IHC testing numbers from 1990 through 2004, click on the following link:
http://www.aphis.usda.gov/lpa/issues/bse/surveillance/figure2f.html
http://www.aphis.usda.gov/lpa/issues/bse_testing/test_results.html
BSE test options were limited
USDA: In 9,200 cases only one type of test could be used
WASHINGTON (AP)--The U.S. Department of Agriculture acknowledged Aug. 17 that its testing options for bovine spongiform encephalopathy were limited in 9,200 cases despite its effort to expand surveillance throughout the U.S. herd.
In those cases, only one type of test was used--one that failed to detect the disease in an infected Texas cow.
The department posted the information on its website because of an inquiry from The Associated Press.
Conducted over the past 14 months, the tests have not been included in the department's running tally of BSE tests since last summer. That total reached 439,126 on Aug. 17.
"There's no secret program," the department's chief veterinarian, John Clifford, said in an interview. "There has been no hiding, I can assure you of that."
Officials intended to report the tests later in an annual report, Clifford said.
These 9,200 cases were different because brain tissue samples were preserved with formalin, which makes them suitable for only one type of test--immunohistochemistry, or IHC.
In the Texas case, officials had declared the cow free of disease in November after an IHC test came back negative. The department's inspector general ordered an additional kind of test, which confirmed the animal was infected.
Veterinarians in remote locations have used the preservative on tissue to keep it from degrading on its way to the department's laboratory in Ames, Iowa. Officials this year asked veterinarians to stop using preservative and send fresh or chilled samples within 48 hours.
The department recently investigated a possible case of BSE that turned up in a preserved sample. Further testing ruled out the disease two weeks ago.
Scientists used two additional tests--rapid screening and Western blot--to help detect BSE in the country's second confirmed case, in a Texas cow in June. They used IHC and Western blot to confirm the first case, in a Washington state cow in December 2003.
"The IHC test is still an excellent test," Clifford said. "These are not simple tests, either."
Clifford pointed out that scientists reran the IHC several times and got conflicting results. That happened, too, with the Western blot test. Both tests are accepted by international animal health officials.
Date: 8/25/05
http://www.hpj.com/archives/2005/aug05/aug29/BSEtestoptionswerelimited.cfm
-------- Original Message -------- Subject: USA BIO-RADs INCONCLUSIVEs Date: Fri, 17 Dec 2004 15:37:28 -0600 From: "Terry S. Singeltary Sr." To: susan_berg@bio-rad.com
Hello Susan and Bio-Rad,
Happy Holidays!
I wish to ask a question about Bio-Rad and USDA BSE/TSE testing and there inconclusive. IS the Bio-Rad test for BSE/TSE that complicated, or is there most likely some human error we are seeing here?
HOW can Japan have 2 positive cows with No clinical signs WB+, IHC-, HP- , BUT in the USA, these cows are considered 'negative'?
IS there more politics working here than science in the USA?
What am I missing?
-------- Original Message -------- Subject: Re: USDA: More mad cow testing will demonstrate beef's safety Date: Fri, 17 Dec 2004 09:26:19 -0600 From: "Terry S. Singeltary Sr." snip...end
Experts doubt USDA's mad cow results
snip...END
WELL, someone did call me from Bio-Rad about this, however it was not Susan Berg. but i had to just about take a blood oath not to reveal there name. IN fact they did not want me to even mention this, but i feel it is much much to important. I have omitted any I.D. of this person, but thought I must document this ;
Bio-Rad, TSS phone conversation 12/28/04
Finally spoke with ;
Bio-Rad Laboratories 2000 Alfred Nobel Drive Hercules, CA 94547 Ph: 510-741-6720 Fax: 510-741-5630 Email: XXXXXXXXXXXXXXXXXX
at approx. 14:00 hours 12/28/04, I had a very pleasant phone conversation with XXXX XXXXX about the USDA and the inconclusive BSE testing problems they seem to keep having. X was very very cautious as to speak directly about USDA and it's policy of not using WB. X was very concerned as a Bio-Rad official of retaliation of some sort. X would only speak of what other countries do, and that i should take that as an answer. I told X I understood that it was a very loaded question and X agreed several times over and even said a political one.
my question;
Does Bio-Rad believe USDA's final determination of False positive, without WB, and considering the new atypical TSEs not showing positive with -IHC and -HP ???
ask if i was a reporter. i said no, i was with CJD Watch and that i had lost my mother to hvCJD. X did not want any of this recorded or repeated.
again, very nervous, will not answer directly about USDA for fear of retaliation, but again said X tell me what other countries are doing and finding, and that i should take it from there. "very difficult to answer"
"very political"
"very loaded question"
outside USA and Canada, they use many different confirmatory tech. in house WB, SAF, along with IHC, HP, several times etc. you should see at several talks meetings (TSE) of late Paris Dec 2, that IHC- DOES NOT MEAN IT IS NEGATIVE. again, look what the rest of the world is doing. said something about Dr. Houston stating; any screening assay, always a chance for human error. but with so many errors (i am assuming X meant inconclusive), why are there no investigations, just false positives? said something about ''just look at the sheep that tested IHC- but were positive''. ...
TSS
-------- Original Message -------- Subject: Your questions Date: Mon, 27 Dec 2004 15:58:11 -0800 From: To: flounder@wt.net
Hi Terry:
............................................snip Let me know your phone number so I can talk to you about the Bio-Rad BSE test. Thank you
Regards
Bio-Rad Laboratories 2000 Alfred Nobel Drive Hercules, CA 94547 Ph: 510-741-6720 Fax: 510-741-5630 Email: =================================
END...TSS
######### https://listserv.kaliv.uni-karlsruhe.de/warc/bse-l.html ##########
Executive Summary
In June 2005, an inconclusive bovine spongiform encephalopathy (BSE) sample from November 2004, that had originally been classified as negative on the immunohistochemistry test, was confirmed positive on SAF immunoblot (Western blot). The U.S. Department of Agriculture (USDA) identified the herd of origin for the index cow in Texas; that identification was confirmed by DNA analysis. USDA, in close cooperation with the Texas Animal Health Commission (TAHC), established an incident command post (ICP) and began response activities according to USDA’s BSE Response Plan of September 2004. Response personnel removed at-risk cattle and cattle of interest (COI) from the index herd, euthanized them, and tested them for BSE; all were negative. USDA and the State extensively traced all at-risk cattle and COI that left the index herd. The majority of these animals entered rendering and/or slaughter channels well before the investigation began. USDA’s response to the Texas finding was thorough and effective.
http://www.aphis.usda.gov/lpa/issues/bse/epi-updates/bse_final_epidemiology_report.pdf
Report on Food & Drug Administration Dallas District Investigation of Bovine Spongiform Encephalopathy Event in Texas 2005
Executive Summary:
On June 24, 2005, USDA informed FDA that a cow in Texas tested positive for Bovine Spongiform Encephalopathy (BSE). Information provided by APHIS was that the BSE positive cow was born and raised in a herd in Texas and was approximately 12 years old. The animal was sampled for BSE at a pet food plant in Texas on November 15, 2004, as part of USDA’s enhanced surveillance program.
http://www.fda.gov/cvm/texasfeedrpt.htm
Texas even had a 'secret' test that showed that mad cow positive;
experimental IHC test results, because the test was
not a validated procedure, and because the two
approved IHC tests came back negative, the results
were not considered to be of regulatory significance
and therefore were not reported beyond the
laboratory.
• A Western blot test conducted the week of
June 5, 2005, returned positive for BSE.
http://www.usda.gov/documents/vs_bse_ihctestvar.pdf
48 hr BSE confirmation turnaround took 7+ months to confirm this case, so the BSE MRR policy could be put into place. ...TSS
THIS highly suspect stumbling and staggering Texas Mad Cow got not test at all, went straight to render ;
FOR IMMEDIATE RELEASE Statement May 4, 2004 Media Inquiries: 301-827-6242 Consumer Inquiries: 888-INFO-FDA
Statement on Texas Cow With Central Nervous System Symptoms On Friday, April 30 th , the Food and Drug Administration learned that a cow with central nervous system symptoms had been killed and shipped to a processor for rendering into animal protein for use in animal feed.
FDA, which is responsible for the safety of animal feed, immediately began an investigation. On Friday and throughout the weekend, FDA investigators inspected the slaughterhouse, the rendering facility, the farm where the animal came from, and the processor that initially received the cow from the slaughterhouse.
FDA's investigation showed that the animal in question had already been rendered into "meat and bone meal" (a type of protein animal feed). Over the weekend FDA was able to track down all the implicated material. That material is being held by the firm, which is cooperating fully with FDA.
Cattle with central nervous system symptoms are of particular interest because cattle with bovine spongiform encephalopathy or BSE, also known as "mad cow disease," can exhibit such symptoms. In this case, there is no way now to test for BSE. But even if the cow had BSE, FDA's animal feed rule would prohibit the feeding of its rendered protein to other ruminant animals (e.g., cows, goats, sheep, bison).
FDA is sending a letter to the firm summarizing its findings and informing the firm that FDA will not object to use of this material in swine feed only. If it is not used in swine feed, this material will be destroyed. Pigs have been shown not to be susceptible to BSE. If the firm agrees to use the material for swine feed only, FDA will track the material all the way through the supply chain from the processor to the farm to ensure that the feed is properly monitored and used only as feed for pigs.
To protect the U.S. against BSE, FDA works to keep certain mammalian protein out of animal feed for cattle and other ruminant animals. FDA established its animal feed rule in 1997 after the BSE epidemic in the U.K. showed that the disease spreads by feeding infected ruminant protein to cattle.
Under the current regulation, the material from this Texas cow is not allowed in feed for cattle or other ruminant animals. FDA's action specifying that the material go only into swine feed means also that it will not be fed to poultry.
FDA is committed to protecting the U.S. from BSE and collaborates closely with the U.S. Department of Agriculture on all BSE issues. The animal feed rule provides crucial protection against the spread of BSE, but it is only one of several such firewalls. FDA will soon be improving the animal feed rule, to make this strong system even stronger.
####
http://www.fda.gov/bbs/topics/news/2004/NEW01061.html
r i g h t ?
10,000,000+ LBS. of PROHIBITED BANNED MAD COW FEED I.E. MBM IN COMMERCE USA 2007
Date: March 21, 2007 at 2:27 pm PST
RECALLS AND FIELD CORRECTIONS: VETERINARY MEDICINES -- CLASS II ___________________________________
PRODUCT
Bulk cattle feed made with recalled Darling’s 85% Blood Meal, Flash Dried, Recall # V-024-2007 CODE Cattle feed delivered between 01/12/2007 and 01/26/2007
RECALLING FIRM/MANUFACTURER
Pfeiffer, Arno, Inc, Greenbush, WI. by conversation on February 5, 2007. Firm initiated recall is ongoing.
REASON
Blood meal used to make cattle feed was recalled because it was cross-contaminated with prohibited bovine meat and bone meal that had been manufactured on common equipment and labeling did not bear cautionary BSE statement.
VOLUME OF PRODUCT IN COMMERCE
42,090 lbs. DISTRIBUTION WI
___________________________________
PRODUCT
Custom dairy premix products: MNM ALL PURPOSE Pellet, HILLSIDE/CDL Prot-Buffer Meal, LEE, M.-CLOSE UP PX Pellet, HIGH DESERT/ GHC LACT Meal, TATARKA, M CUST PROT Meal, SUNRIDGE/CDL PROTEIN Blend, LOURENZO, K PVM DAIRY Meal, DOUBLE B DAIRY/GHC LAC Mineral, WEST PIONT/GHC CLOSEUP Mineral, WEST POINT/GHC LACT Meal, JENKS, J/COMPASS PROTEIN Meal, COPPINI – 8# SPECIAL DAIRY Mix, GULICK, L-LACT Meal (Bulk), TRIPLE J – PROTEIN/LACTATION, ROCK CREEK/GHC MILK Mineral, BETTENCOURT/GHC S.SIDE MK-MN, BETTENCOURT #1/GHC MILK MINR, V&C DAIRY/GHC LACT Meal, VEENSTRA, F/GHC LACT Meal, SMUTNY, A-BYPASS ML W/SMARTA, Recall # V-025-2007 CODE The firm does not utilize a code - only shipping documentation with commodity and weights identified.
RECALLING FIRM/MANUFACTURER
Rangen, Inc, Buhl, ID, by letters on February 13 and 14, 2007. Firm initiated recall is complete. REASON Products manufactured from bulk feed containing blood meal that was cross contaminated with prohibited meat and bone meal and the labeling did not bear cautionary BSE statement.
VOLUME OF PRODUCT IN COMMERCE
9,997,976 lbs.
DISTRIBUTION ID and NV
END OF ENFORCEMENT REPORT FOR MARCH 21, 2007
http://www.fda.gov/bbs/topics/enforce/2007/ENF00996.html
OR THE OTHER BSE INCONCLUSIVE THAT SAT ON A SHELF FOR 4 MONTHS WHILE THE USDA BSE MRR POLICY WAS PUT IN MOTION, simply because this guy forgets to send sample in, ooops ;
"I would note that the sample was taken in April, at which time the protocols allowed for a preservative to be used. The sample was not submitted to us until last week because the veterinarian set aside the sample after preserving it and simply forgot to send it in.
http://www.usda.gov/wps/portal/usdahome?contentidonly=true&contentid=2005/07/0280.xml
THE TEXAS GONZALES/PURINA INCIDENT SHOWED THAT 5.5 GRAMS OF RUMINANT PROTEIN WAS FED TO CATTLE ;
FOR IMMEDIATE RELEASE P01-05 January 30, 2001 Print Media: 301-827-6242 Broadcast Media: 301-827-3434 Consumer Inquiries: 888-INFO-FDA
FDA ANNOUNCES TEST RESULTS FROM TEXAS FEED LOT
Today the Food and Drug Administration announced the results of tests taken on feed used at a Texas feedlot that was suspected of containing meat and bone meal from other domestic cattle -- a violation of FDA's 1997 prohibition on using ruminant material in feed for other ruminants. Results indicate that a very low level of prohibited material was found in the feed fed to cattle.
FDA has determined that each animal could have consumed, at most and in total, five-and-one-half grams - approximately a quarter ounce -- of prohibited material. These animals weigh approximately 600 pounds.
It is important to note that the prohibited material was domestic in origin (therefore not likely to contain infected material because there is no evidence of BSE in U.S. cattle), fed at a very low level, and fed only once. The potential risk of BSE to such cattle is therefore exceedingly low, even if the feed were contaminated.
According to Dr. Bernard Schwetz, FDA's Acting Principal Deputy Commissioner, "The challenge to regulators and industry is to keep this disease out of the United States. One important defense is to prohibit the use of any ruminant animal materials in feed for other ruminant animals. Combined with other steps, like U.S. Department of Agriculture's (USDA) ban on the importation of live ruminant animals from affected countries, these steps represent a series of protections, to keep American cattle free of BSE."
Despite this negligible risk, Purina Mills, Inc., is nonetheless announcing that it is voluntarily purchasing all 1,222 of the animals held in Texas and mistakenly fed the animal feed containing the prohibited material. Therefore, meat from those animals will not enter the human food supply. FDA believes any cattle that did not consume feed containing the prohibited material are unaffected by this incident, and should be handled in the beef supply clearance process as usual.
FDA believes that Purina Mills has behaved responsibly by first reporting the human error that resulted in the misformulation of the animal feed supplement and then by working closely with State and Federal authorities.
This episode indicates that the multi-layered safeguard system put into place is essential for protecting the food supply and that continued vigilance needs to be taken, by all concerned, to ensure these rules are followed routinely.
FDA will continue working with USDA as well as State and local officials to ensure that companies and individuals comply with all laws and regulations designed to protect the U.S. food supply.
http://www.fda.gov/bbs/topics/NEWS/2001/NEW00752.html
P04.27
Experimental BSE Infection of Non-human Primates: Efficacy of the Oral Route
Holznagel, E1; Yutzy, B1; Deslys, J-P2; Lasmézas, C2; Pocchiari, M3;Ingrosso, L3;Bierke, P4; Schulz-Schaeffer, W5; Motzkus, D6; Hunsmann, G6; Löwer, J11Paul-Ehrlich-Institut, Germany;2Commissariat à l´Energie Atomique, France;3Instituto Superiore di Sanità, Italy;4Swedish Institute for Infectious Disease control, Sweden;5Georg August University, Germany;6German Primate Center, Germany
Background:
In 2001, a study was initiated in primates to assess the risk for humans to contract BSE through contaminated food. For this purpose, BSE brain was titrated in cynomolgus monkeys.
Aims:
The primary objective is the determination of the minimal infectious dose (MID50) for oral exposure to BSE in a simian model, and, by in doing this, to assess the risk for humans.
Secondly, we aimed at examining the course of the disease to identify possible biomarkers.
Methods:
Groups with six monkeys each were orally dosed with lowering amounts of BSE brain: 16g, 5g, 0.5g, 0.05g, and 0.005g. In a second titration study, animals were intracerebrally (i.c.) dosed (50, 5, 0.5, 0.05, and 0.005 mg).
Results:
In an ongoing study, a considerable number of high-dosed macaques already developed simian vCJD upon oral or intracerebral exposure or are at the onset of the clinical phase. However, there are differences in the clinical course between orally and intracerebrally infected animals that may influence the detection of biomarkers.
Conclusions:
Simian vCJD can be easily triggered in cynomolgus monkeys on the oral route using less than 5 g BSE brain homogenate. The difference in the incubation period between 5 g oral and 5 mg i.c. is only 1 year (5 years versus 4 years). However, there are rapid progressors among orally dosed monkeys that develop simian vCJD as fast as intracerebrally inoculated animals. The work referenced was performed in partial fulfilment of the study "BSE in primates" supported by the EU (QLK1-2002-01096).
http://www.prion2007.com/pdf/Prion%20Book%20of%20Abstracts.pdf
From: TSS (216-119-144-34.ipset24.wt.net) Subject: 1 in 2 CHANCE OF GETTING BSE AKA MAD COW BY THE ORAL ROUTE (PRIMATE STUDY) Date: January 27, 2005 at 7:03 am PST
Risk of oral infection with bovine spongiform encephalopathy agent in primates
Corinne Ida Lasmézas, Emmanuel Comoy, Stephen Hawkins, Christian Herzog, Franck Mouthon, Timm Konold, Frédéric Auvré, Evelyne Correia, Nathalie Lescoutra-Etchegaray, Nicole Salès, Gerald Wells, Paul Brown, Jean-Philippe Deslys Summary The uncertain extent of human exposure to bovine spongiform encephalopathy (BSE)--which can lead to variant Creutzfeldt-Jakob disease (vCJD)--is compounded by incomplete knowledge about the efficiency of oral infection and the magnitude of any bovine-to-human biological barrier to transmission. We therefore investigated oral transmission of BSE to non-human primates. We gave two macaques a 5 g oral dose of brain homogenate from a BSE-infected cow. One macaque developed vCJD-like neurological disease 60 months after exposure, whereas the other remained free of disease at 76 months. On the basis of these findings and data from other studies, we made a preliminary estimate of the food exposure risk for man, which provides additional assurance that existing public health measures can prevent transmission of BSE to man.
BSE bovine brain inoculum
100 g 10 g 5 g 1 g 100 mg 10 mg 1 mg 0·1 mg 0·01 mg
Primate (oral route)* 1/2 (50%)
Cattle (oral route)* 10/10 (100%) 7/9 (78%) 7/10 (70%) 3/15 (20%) 1/15 (7%) 1/15 (7%)
RIII mice (ic ip route)* 17/18 (94%) 15/17 (88%) 1/14 (7%)
PrPres biochemical detection
The comparison is made on the basis of calibration of the bovine inoculum used in our study with primates against a bovine brain inoculum with a similar PrPres concentration that was
inoculated into mice and cattle.8 *Data are number of animals positive/number of animals surviving at the time of clinical onset of disease in the first positive animal (%). The accuracy of
bioassays is generally judged to be about plus or minus 1 log. ic ip=intracerebral and intraperitoneal.
Table 1: Comparison of transmission rates in primates and cattle infected orally with similar BSE brain inocula
Published online January 27, 2005
http://www.thelancet.com/journal/journal.isa
It is clear that the designing scientists must
also have shared Mr Bradley’s surprise at the results because all the dose
levels right down to 1 gram triggered infection.
http://www.bseinquiry.gov.uk/files/ws/s145d.pdf
6. It also appears to me that Mr Bradley’s answer (that it would take less than say 100 grams) was probably given with the benefit of hindsight; particularly if one considers that later in the same answer Mr Bradley expresses his surprise that it could take as little of 1 gram of brain to cause BSE by the oral route within the same species. This information did not become available until the "attack rate" experiment had been completed in 1995/96. This was a titration experiment designed to ascertain the infective dose. A range of dosages was used to ensure that the actual result was within both a lower and an upper limit within the study and the designing scientists would not have expected all the dose levels to trigger infection. The dose ranges chosen by the most informed scientists at that time ranged from 1 gram to three times one hundred grams. It is clear that the designing scientists must have also shared Mr Bradley’s surprise at the results because all the dose levels right down to 1 gram triggered infection.
http://www.bseinquiry.gov.uk/files/ws/s147f.pdf
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.
According to the Procedure Manual for BSE Surveillance, dated October 2004, the target population includes:
Central nervous system (CNS) signs and/or rabies negative - sample animals of any age (emphasis added):
a. Diagnostic laboratories –samples submitted due to evidence of CNS clinical signs.
Rabies Negative Samples
USDA/OIG-A/50601-10-KC Page 19 USDA/OIG-A/50601-10-KC Page 20
b. Public health laboratories – rabies negative cases.
c. Slaughter facilities – CNS ante mortem condemned at slaughter, sampled by FSIS.
d. On-the-farm – CNS cattle that do not meet the criteria for a foreign animal disease investigation.
For FYs 2002, 2003, and 2004 (through February 2004), NVSL received 170, 133, and 45 rabies-negative samples, respectively. Between June 1, 2004, and May 29, 2005, the number of samples received for testing increased to 226 rabies suspect samples. The collection sites submitting these samples follow.
Number of Rabies Suspect Submissions *
Slaughter Plant 0
Renderer 2
On-Farm 11
Public Health Lab 94
Diagnostic Lab 81
3D-4D 8
Other 4
Collection Site
Total
200
* 26 were tested but not counted by APHIS towards meeting the target goals because the obex was not submitted.
We obtained a copy of a memorandum, dated July 13, 2004, that APHIS sent to diagnostic and public health laboratories providing them instructions on submitting samples for cattle showing signs of CNS diseases, but testing negative for rabies. The letter was sent to about 170 State veterinary diagnostic and public health laboratories and discussed the need to submit specimens to NVSL of all adult cattle (emphasis added) that showed signs of CNS diseases, but tested negative for rabies. This directive did not specify the age of the cattle. The Procedure Manual for BSE Surveillance, dated October 2004, specified samples of cattle of any age should be submitted.
We contacted laboratories in six States to determine if it was standard procedure to submit all negative rabies samples to NVSL. We found that, because of the lack of specificity in the APHIS letter and inadequate followup by APHIS, there were inconsistencies in the age of cattle samples submitted for BSE testing. For those States contacted, the following samples were submitted versus tested as negative for rabies.
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Rabies Negative Tests Not Sent for BSE Testing Since June 1, 2004 State Negative Rabies Tests
Not Sent for BSE Testing Pennsylvania a/
15 18 Kansas b/
69 16 Wisconsin c/
1 11 South Dakota d/
0 7 Arizona e/
5 0 Mississippi e/
4 0 Total
Sent for BSE Testing
33
85
12
7
5
4
146
94
52
a/ A Pennsylvania laboratory official said only rabies negative cattle over 20 months of age were submitted for BSE testing. The laboratory did not submit 18 samples for BSE testing because the animals were less than 20 months of age.
b/ Kansas laboratory officials said early in the expanded surveillance program, there was confusion as to the cattle ages that should be submitted for BSE testing. They did not know if cattle should be submitted that were above 20 months or 30 months of age. Of the 16 animals not submitted for BSE testing, 14 were under 20 months of age from early in the expanded surveillance program. The other two animals were not tested due to internal laboratory issues. The Kansas and Nebraska area office officials contacted the laboratory and told the officials to submit rabies negative cattle of any age for BSE testing. The laboratory now submits all rabies negative cattle for BSE testing.
c/ A Wisconsin laboratory official said only rabies negative cattle samples 30 months of age or older are submitted for BSE testing. Of the 11 animals not submitted for BSE testing, 8 were less than 30 months of age. Wisconsin laboratory officials were not certain why the other three samples were not submitted.
d/ Laboratory officials from South Dakota said they did not receive notification from APHIS regarding the submission of rabies negative cases for BSE testing. The section supervisor and laboratory director were not aware of any letter sent to the laboratory. The section supervisor said most bovine rabies tests at the laboratory are performed on calves. We confirmed the laboratory’s address matched the address on APHIS’ letter distribution list. However, there was no evidence that the South Dakota area office contacted the laboratory. The laboratory was not listed on the documentation from the APHIS regional office detailing the area office contacts with laboratory personnel. We contacted the South Dakota area office and were advised that while some contact had been made with the laboratory, the contact may have involved Brucellosis rather than BSE. On May 4, 2005, the area office
33 Report from the Secretary’s Advisory Committee on Foreign Animal and Poultry Diseases, February 13, 2004.
advised us they recently contacted the laboratory regarding the submission of rabies negative samples for BSE testing.
e/ Arizona and Mississippi laboratory officials said they submitted all rabies negative samples for BSE testing regardless of the age of the animal.
An NVSL official stated that APHIS is not concerned with rabies negatives samples from cattle less than 30 months of age. This position, however, is contrary to APHIS’ published target population.
Our prior audit recognized the significant challenge for APHIS to obtain samples from some high-risk populations because of the inherent problems with obtaining voluntary compliance and transporting the carcasses for testing. USDA issued rules to prohibit nonambulatory animals (downers) from entering the food supply at inspected slaughterhouses. OIG recommended, and the International Review Subcommittee33 emphasized, that USDA should take additional steps to assure that facilitated pathways exist for dead and nonambulatory cattle to allow for the collection of samples and proper disposal of carcasses. Between June 1, 2004, and May 31, 2005, the APHIS database documents 27,617 samples were collected showing a reason for submission of nonambulatory and 325,225 samples were collected with reason of submission showing "dead."
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
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34 FSIS regulations do not specifically address the designation of an establishment’s "official" boundaries; however, FSIS Notices 29-04 (dated May 27, 2004) and 40-04 (dated July 29, 2004) make it clear that FSIS inspection staff are not responsible for sampling dead cattle that are not part of the "official" premises.
35 APHIS’ area office personnel stated that it was their understanding that some establishments in the State were not presenting cattle that died or were down on the transport vehicle to FSIS for ante mortem inspection. The dead and down cattle were left in the vehicle, if possible. In rare circumstances, dead cattle may be removed from the trailer by plant personnel to facilitate the unloading of other animals.
36 A May 20, 2004, Memorandum between the Administrators of APHIS and FSIS.
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."
USDA/OIG-A/50601-10-KC Page 24
37 FSIS Notice 40-04, dated July 29, 2004.
38 FSIS Notice 29-04, dated May 27, 2004.
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."
We obtained 123 APHIS sampling agreements and contracts with firms and plotted their locations within the United States (see exhibit F). We also analyzed the samples tested to the BSE sampling goals allocated to each State under the prior surveillance program. This analysis showed that there are
USDA/OIG-A/50601-10-KC Page 26
39APHIS noted that sites with agreements do not necessarily reflect the entire universe of collection sites and at some sites APHIS collects samples with no payment involved and no agreement in place. OIG agrees that not all collection sites are reflected in our presentation of the 123 sites with reimbursable agreements. OIG believes obtaining sampling agreements is one of the primary methods available to increase sample numbers in areas with sampling gaps.
sampling gaps in two large areas of the United States where APHIS did not have contracts with collection sites. These two areas are shown in the following chart (Montana, South Dakota, North Dakota and Wyoming – Group 1 and Louisiana, Oklahoma, Arkansas, and Tennessee – Group 2): State
Original Sampling Goal Based on (268,500 sampling goal)
Samples collected as of May 31, 2005
No. of BSE Sampling Agreements/ Contracts39 snip...see chart in pdf full text link. ...tss
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.
snip...
USDA Testing Protocols and Quality Assurance Procedures
In November 2004, USDA announced that its rapid screening test produced an inconclusive BSE test result. A contract laboratory ran its rapid screening test on a brain sample collected for testing and produced three high positive reactive results. As required, the contract laboratory forwarded the inconclusive sample to APHIS’ National Veterinary Services Laboratories (NVSL) for confirmation. NVSL repeated the rapid screening test, which again produced three high positive reactive results. Following established protocol, NVSL ran its confirmatory test, an immunohistochemistry (IHC) test, which was interpreted as negative for BSE.
Faced with conflicting results between the rapid screening and IHC tests, NVSL scientists recommended additional testing to resolve the discrepancy but APHIS headquarters officials concluded that no further testing was necessary since testing protocols were followed and the confirmatory test was negative. In our discussions with APHIS officials, they justified their decision to not do additional testing because the IHC test is internationally recognized as the "gold standard" of testing. Also, they believed that
USDA/OIG-A/50601-10-KC/ Page iv
conducting additional tests would undermine confidence in USDA’s testing protocols.
OIG obtained evidence that indicated additional testing was prudent. We came to this conclusion because the rapid screening tests produced six high positive reactive results, the IHC tests conflicted, and various standard operating procedures were not followed. Also, our review of the relevant scientific literature, other countries’ protocols, and discussions with experts led us to conclude that additional confirmatory testing should be considered in the event of conflicting test results.
To maintain objectivity and independence, we requested that USDA’s Agricultural Research Service (ARS) perform the Office International des Epizooties (OIE) Scrapie-Associated Fibrils (SAF) immunoblot test. The additional testing produced positive results. To confirm, the Secretary of Agriculture requested that an internationally recognized BSE laboratory in Weybridge, England (Weybridge) perform additional testing. Weybridge conducted various tests, including their own IHC tests and three Western blot tests. The tests confirmed that the cow was infected with BSE. The Secretary immediately directed USDA scientists to work with international experts to develop new protocols that include performing dual confirmatory tests in the event of an inconclusive BSE screening test.
We attribute the failure to identify the BSE positive sample to rigid protocols, as well as the lack of adequate quality assurance controls over its testing program. Details of our concerns are discussed in Findings 3 and 4.
snip...
Section 2. Testing Protocols and Quality Assurance Controls In November 2004, USDA announced that its rapid screening test, Bio-Rad Enzyme Linked Immunosorbent Assay (ELISA), produced an inconclusive BSE test result as part of its enhanced BSE surveillance program. The ELISA rapid screening test performed at a BSE contract laboratory produced three high positive reactive results.40 As required,41 the contract laboratory forwarded the inconclusive sample to the APHIS National Veterinary Services Laboratories (NVSL) for confirmatory testing. NVSL repeated the ELISA testing and again produced three high positive reactive results.42 In accordance with its established protocol, NVSL ran its confirmatory test, an immunohistochemistry (IHC) test, which was interpreted as negative for BSE. In addition, NVSL performed a histological43 examination of the tissue and did not detect lesions44 consistent with BSE. Faced with conflicting results, NVSL scientists recommended additional testing to resolve the discrepancy but APHIS headquarters officials concluded no further testing was necessary because testing protocols were followed. In our discussions with APHIS officials, they justified their decision not to do additional testing because the IHC is internationally recognized as the “gold standard.” Also, they believed that conducting additional tests would undermine confidence in USDA’s established testing protocols. However, OIG obtained evidence that indicated additional testing was prudent to ensure that USDA’s testing protocols were effective in detecting BSE and that confidence in USDA’s testing procedures was maintained. OIG came to this conclusion because the rapid tests produced six high positive reactive results, confirmatory testing conflicted with the rapid test results, and various standard operating procedures were not followed. Also, our review of scientific literature, other country protocols, as well as discussions with internationally recognized experts led us to conclude that confirmatory testing should not be limited when conflicting test results are obtained. To maintain objectivity and independence in our assessment, we requested the USDA Agricultural Research Service (ARS) perform the Office International des Epizooties (OIE) Scrapie-Associated Fibrils (SAF) 40 ELISA test procedures require two additional (duplicate) tests if the initial test is reactive, before final interpretation. If either of the duplicate tests is reactive, the test is deemed inconclusive. 41 Protocol for BSE Contract Laboratories to Receive and Test Bovine Brain Samples and Report Results for BSE Surveillance Standard Operating Procedure (SOP), dated October 26, 2004. 42 The NVSL conducted an ELISA test on the original material tested at the contract laboratory and on two new cuts from the sample tissue. 43 A visual examination of brain tissue by a microscope. 44 A localized pathological change in a bodily organ or tissue.
immunoblot.45 ARS performed the test at the National Animal Disease Center because NVSL did not have the necessary equipment46 (ultracentrifuge) to do the test. APHIS scientists observed and participated, as appropriate, in this effort. The additional tests conducted by ARS produced positive results. To confirm this finding, the Secretary requested the internationally recognized BSE reference laboratory in Weybridge, England, (Weybridge) to perform additional confirmatory testing. Weybridge conducted various tests, including their own IHC methods, as well as three Western blot methods. The tests confirmed that the suspect cow was infected with BSE. Also, Weybridge confirmed this case as an unequivocal positive case of BSE on the basis of IHC. As a result of this finding, the Secretary immediately directed USDA scientists to work with international experts to develop a new protocol that includes performing dual confirmatory tests in the event of another inconclusive BSE screening test. Finding 3 Rigid Protocols Reduced the Likelihood BSE Could be Detected APHIS relied on a single test method, as well as a histological examination of tissue for lesions consistent with BSE, to confirm the presence of BSE even though discrepant test results indicated further testing may be prudent. When IHC test results were interpreted as negative, APHIS concluded the sample tested negative for BSE. Subsequent independent tests initiated by OIG using a different testing method, as well as confirmatory testing by Weybridge, determined that the suspect sample was a positive case of BSE. APHIS Declares BSE Sample Negative Despite Conflicting Results When the tissue sample originally arrived at NVSL in November 2004 from the contract lab, NVSL scientists repeated the ELISA screening test and again produced three high positive reactive results. NVSL scientists cut out two sections of the brain sample for IHC testing. One section was used for an experimental procedure that was not part of the confirmatory testing protocol, and the other cut was for normal IHC testing using scrapie for a positive control.47 According to NVSL scientists, the experimental test results were inconclusive but the IHC test was interpreted as negative. The NVSL scientists were concerned with the inconsistencies and conducted 45 The OIE SAF immunoblot is an internationally recognized confirmatory test, often referred to as a Western blot test. There are different types of Western blots; the OIE SAF immunoblot includes enrichment steps taken with the sample prior to the standard Western blot steps. 46 APHIS has now ordered the necessary equipment for NVSL. USDA/OIG-A/50601-10-KC Page 32
47 A positive control is a sample that is known to contain a given disease or react in the test. The sample then can be used to make sure that the test for that disease works properly. In the case of BSE, tissue infected with either scrapie or BSE can serve as a positive control for an IHC test for BSE since both are different forms of the same disease (transmissible spongiform encephalopathy or TSE).
another IHC test using BSE as a positive control.48 The test result was also interpreted as negative. Also, according to the NVSL scientists, the histological examination of the tissue did not detect lesions consistent with BSE. After the second negative IHC test, NVSL scientists supported doing additional testing. They prepared a plan for additional tests; if those tests had been conducted, BSE may have been detected in the sample. The additional tests recommended by NVSL scientists, but not approved by APHIS Headquarters officials, were the IHC using other antibodies (IHC testing using different antibodies ultimately produced positive results); IHC testing of additional regions of the brain (the cerebellum tested positive); regular and enriched (OIE-like) Western blots (the obex and cerebellum tested positive); and variable rapid tests (the obex and cerebellum tested positive with two different rapid tests). NVSL officials also recommended that the sample be sent to Weybridge for confirmatory testing (to conduct IHC and OIE Western blot tests). In June 2005, Weybridge conducted IHC testing with three different antibodies, including the antibody used in the United States (tested positive), the OIE Western blot (tested positive), a modified commercial kit Western blot (negative) and the NaPTA49 Western blot (tested positive). We obtained information as to the differing protocols used by other countries. We found that while APHIS determined that additional testing was unnecessary after the IHC test, other countries have used multiple tests to confirm positives. In Japan, for example, all reactive screening test samples are examined by both IHC and a Western blot (different from the OIE SAF immunoblot). In the United Kingdom (U.K.), IHC and Western blot (different from the OIE SAF immunoblot) tests are used for all animals that test positive with a screening test. When IHC and the Western blot fail to confirm a positive rapid test, the U.K. resorts to a third test, the OIE SAF immunoblot. With these procedures in place, both Japan and the U.K. have found BSE cases that were rapid test reactive, IHC negative, and finally confirmed positive with a Western blot. Evidence Indicated Additional Testing Would Be Prudent We also spoke with an internationally recognized BSE expert regarding the advisability of limiting confirmatory testing when conflicting results are obtained. This official expressed concern about limiting confirmatory tests to the IHC despite its status as one of the “gold standard” tests. He advised that the IHC is not one test; it is a test method that can vary significantly in sensitivity from laboratory to laboratory. New antibodies can improve or
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48 The NVSL uses scrapie as the positive control as part of its normal IHC testing procedures. Due to the conflicting results between the ELISA and IHC tests, the NVSL conducted another IHC test with BSE as the positive control. Subsequently, the NVSL modified the Confirming Inconclusive Results from BSE Testing Laboratories at the NVSL SOP to show that all IHC tested BSE inconclusive samples from contract laboratories will use BSE as the positive control. 49 Sodium phosphotungstic acid.
USDA/OIG-A/50601-10-KC Page 34
reduce sensitivity, as can variations in many of the reagents50 used. He explained that his laboratory had experienced cases where an initial confirmatory IHC test was challenged by either a more extensive IHC test or “…applying a more sensitive immunoblot.” He emphasized the importance of having additional confirmatory testing to resolve discrepant results since there are many variables, and most of the variability appears to be due to test performance of the laboratory. OIG became concerned that APHIS relied on its confirmatory test methods when rapid screening tests produced high positive reactive results six times.51 Also, we found that APHIS did not pursue and/or investigate why the ELISA produced high reactive positives. An official from the manufacturer of the ELISA test kit told us that they requested, but did not receive, information on the inconclusive reported by USDA in November 2004. These officials requested this information in order to understand the reasons for the discrepant results. The Bio-Rad ELISA rapid screening test is internationally recognized as a highly reliable test and is the rapid screening test used for USDA’s surveillance effort. According to APHIS officials, they felt it would be inappropriate to collaborate on the one sample because Bio-Rad is a USDA-APHIS regulated biologics company and only one of several competing manufacturers. To maintain confidence in USDA’s test protocols, it would have been a prudent course of action for USDA to determine why such significant differing results were obtained. The fact that they did not pursue this matter caused concerns relating to testing quality assurance procedures. In this regard, we found lack of compliance with SOPs relating to laboratory proficiency and quality assurance (see Finding 4), and, in this case, the storage of sampled material and reporting of test results. We found that the NVSL did not prepare a report to document its confirmatory testing of the November 2004 sample. The SOP52 states that the BSE network laboratory initiating the inconclusive will receive a report of the case. NVSL officials could not explain why a final report had not been prepared. We also found that the inconclusive sample was frozen prior to IHC confirmatory testing. APHIS protocols state that samples are not to be frozen prior to laboratory submission. The OIE Manual of Diagnostic Tests and Vaccines for Terrestrial Animals states that the tissues for histological or IHC examination are not to be frozen as this will provide artefactual53 lesions that may compromise the identification of vacuolation,54 and/or target site location. Although the sample was frozen, APHIS did not conduct a Western 50 A substance used in a chemical reaction to detect, measure, examine, or produce other substances. 51 The six high positive reactive results were from three tests of the submitted sample (multiple runs of the same test). 52 Confirming Inconclusive Results from Bovine Spongiform Encephalopathy Testing Laboratories at the NVSL SOP, dated August 13, 2004. 53 A structure or feature not normally present but visible as a result of an external agent or action, such as one seen in a microscopic specimen after fixation. 54 A small space or cavity in a tissue.
USDA/OIG-A/50601-10-KC Page 35
blot test on the sample. An NVSL official said freezing the sample does not make it unsuitable for IHC. APHIS determined that the sample was suitable for IHC and therefore, in accordance with its SOP, did not conduct a Western blot test. APHIS also handled the December 2003 BSE positive differently than the November 2004 sample. For the December 2003 BSE positive sample, APHIS conducted several confirmatory tests in addition to the IHC testing and histological examination (unlike the November 2004 sample tests, both of these were interpreted as positive). ARS performed two Western blots (Prionics Check Western blot and an ARS developed Western blot). When we questioned why the samples were handled differently, APHIS officials stated that the Western blots were done because the IHC in December 2003 was positive. The additional testing was done to further characterize the case, because it was the first U.S. case; the additional testing was not done to decide whether the case was positive or negative. We discussed our concerns with limiting confirmatory testing, particularly given conflicting results, with the APHIS Administrator and staff in May 2005. He explained that international standards recognized more than one “gold standard” test. In setting up its testing protocols, USDA had chosen one as the confirming test, the IHC test, and stayed with it. APHIS protocols only allow a Western blot in cases where the sample has become unsuitable for IHC tests (e.g., in cases where the brainstem architecture is not evident). International standards, he continued, accept a tissue sample as negative for BSE if its IHC test is negative. Once the test is run in accordance with protocols, additional tests undermine the USDA testing protocol and the surveillance program. He concluded that since APHIS’ protocols accepted the IHC test as confirming the presence or absence of BSE, no further testing was necessary. According to protocol, the tissue sample was determined to have tested negative for BSE. On June 24, 2005, USDA announced that the additional testing by the BSE reference laboratory in England confirmed the presence of BSE in the tissue sample. To obviate the possibility that a future sample would be declared negative and then found positive, the Secretary of Agriculture announced a change to APHIS’ testing protocols that same day. He called for “dual confirmatory tests in the event of another ‘inconclusive’ [reactive] BSE screening test.” He also indicated that he would reinforce proper procedures so that samples will not be frozen, and to spot-check the laboratories to see that they complete reports as required. APHIS issued a SOP on the new confirmatory testing protocols on November 30, 2005.
http://www.usda.gov/oig/webdocs/50601-10-KC.pdf
For the period of time from January 1, 2005, until October 15, 2005, there were 23 instances of discrepancies in results from 35 flocks. Of those 23 instances, 14 were caused by laboratory error (paperwork or sample mix-up), 3 results from field error, 5 were not completely resolved, and 1 originated from the use of a non-approved laboratory for the first test. As a result of inconsistencies, one laboratory’s certification was revoked by APHIS-VS.
http://www.usaha.org/committees/reports/2005/report-scr-2005.pdf
Suppressed PEER REVIEW of the Harvard BSE study of October 31, 2002
http://www.fsis.usda.gov/oa/topics/BSE_Peer_Review.pdf
THE SEVEN SCIENTIST REPORT ***
http://www.fda.gov/ohrms/dockets/dockets/02n0273/02n-0273-EC244-Attach-1.pdf
Subject: [Docket No. FSIS-2006-0011] FSIS Harvard Risk Assessment of Bovine Spongiform Encephalopathy (BSE)
http://www.fsis.usda.gov/OPPDE/Comments/2006-0011/2006-0011-1.pdf
[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
9/13/2005
http://www.fsis.usda.gov/OPPDE/Comments/03-025IFA/03-025IFA-2.pdf
Docket Management Docket: 02N-0273 - Substances Prohibited From Use in
Animal Food or Feed; Animal Proteins Prohibited in Ruminant Feed
Comment Number: EC -10
Accepted - Volume 2
http://www.fda.gov/ohrms/dockets/dailys/03/Jan03/012403/8004be07.html
PART 2
http://www.fda.gov/ohrms/dockets/dailys/03/Jan03/012403/8004be09.html
Date: Thu, 1 Mar 2007 14:57:20 -0600 Reply-To: Sustainable Agriculture Network Discussion Group Sender: Sustainable Agriculture Network Discussion Group From: "Terry S. Singeltary Sr." <[log in to unmask]> Subject: Re: O.I.E. SELLS THERE SOUL TO THE DEVIL AND WILL REPEAT WHAT THE U.K. DID, POISON THE WORLD LEGALLY WITH MAD COW DISEASEs
http://lists.ifas.ufl.edu/cgi-bin/wa.exe?A2=ind0703&L=sanet-mg&P=498
THE OIE has now shown they are nothing more than a National Trading Brokerage for all strains of animal TSE.
AS i said before, OIE should hang up there jock strap now, since it appears they will buckle every time a country
makes some political hay about trade protocol, commodities and futures. IF they are not going to be science based, they
should do everyone a favor and dissolve there organization. ...
Page 95 of 98
8/3/2006
WHAT ABOUT RISK FACTORS TO HUMANS FROM ALL OTHER TSEs, WITH RELATIONS TO SRMs ???
a.. BSE OIE
see full text ;
http://p079.ezboard.com/fwolftracksproductionsfrm2.showMessage?topicID=470.topic
IT'S as obvious as day and night, either Larry, Curley, and Mo have been at the helm of the
USDA/APHIS/FSIS/FDA/CDC/NIH et al for many many years, or the incompetence of these agencies are so inept,
either through ignorance and or just too overweight with industry reps., they then should be all done away with and a
single agency brought forth, and if not, how will you correct this ongoing problem ?
GWs and his sleeping partners at the OIE, gave birth to the BSE MRR policy, the legal. trading of all strains of TSE globally ...
http://www.fsis.usda.gov/OPPDE/Comments/2006-0011/2006-0011-1.pdf
http://lists.ifas.ufl.edu/cgi-bin/wa.exe?A2=ind0612&L=sanet-mg&T=0&P=20678
http://lists.ifas.ufl.edu/cgi-bin/wa.exe?A2=ind0611&L=sanet-mg&T=0&I=-3&P=3381
IN A NUT SHELL ;
(Adopted by the International Committee of the OIE on 23 May 2006)
11. Information published by the OIE is derived from appropriate declarations made by the official Veterinary Services of Member Countries. The OIE is not responsible for inaccurate publication of country disease status based on inaccurate information or changes in epidemiological status or other significant events that were not promptly reported to the Central Bureau,
http://www.oie.int/eng/Session2007/RF2006.pdf
AS I SAID, bought and paid for by your local cattle dealer i.e. USDA. The status of USA for BSE that is to be announced in May 2007 by OIE, has already been decided, and it's a big fat lie. This is like letting a known, and convicted criminal, prosecute themselves. They will find themselves innocent every time. It's a win/win situation for the industry, and the consumer cr@ps out again, snake eyes, you loose. ...
National Center for Import and Export Sanitary International Standards Team World Organization for Animal Health - (OIE)
Draft Proposals October 2006 Comments Submitted to OIE Proposed for Adoption at General Session May 2007
Draft Proposals October 2006
Bovine Spongiform Encephalopathy (pdf) (rtf)
http://www.aphis.usda.gov/NCIE/oie/pdf_files/tahc-bse-75-oct06.pdf
http://www.aphis.usda.gov/NCIE/oie/rtf_files/tahc-bse-75-oct06.rtf
Comments Submitted to OIE
Bovine Spongiform Encephalopathy (pdf) (rtf)
http://www.aphis.usda.gov/NCIE/oie/pdf_files/tahc-bse-75-oct06_cmt.pdf
http://www.aphis.usda.gov/NCIE/oie/rtf_files/tahc-bse-75-oct06_cmt.rtf
Proposed for Adoption at General Session May 2007
Bovine Spongiform Encephalopathy (pdf)
http://www.aphis.usda.gov/NCIE/oie/pdf_files/tahc-bse-75-mar07.pdf
Monthly Test Results APHIS reports ongoing surveillance totals monthly. The BSE ongoing surveillance program will sample approximately 40,000 animals each year. Under the program, USDA will continue to collect samples from a variety of sites and from the cattle populations where the disease is most likely to be detected, similar to the enhanced surveillance program procedures.
BSE Ongoing Surveillance Program Cumulative Total
From Sep 1, 2006: 46,673
Month Number of Tests
Sep 2007 3,832 Aug 2007 5,433 Jul 2007 4,267 Jun 2007 4,106 May 2007 5,217 Apr 2007 5,104 Mar 2007 4,130 Feb 2007 2,937 Jan 2007 3,075 Dec 2006 2,477 Nov 2006 2,235 Oct 2006 2,068 Sep 2006 1,792
snip...end
http://www.aphis.usda.gov/newsroom/hot_issues/bse/surveillance/ongoing_surv_results.shtml
let's see now, from a USA cattle herd of some 95 million head, the expanded 2004 BSE cover-up that suddenly halted after the finding of the 2 BASE cases i.e. atypical h-BSE documented in Alabama and Texas, this after rendering another stumbling and staggering mad cow in Texas that was suspect BSE, but _no_ test at all was given, and after suspect BSE samples sat stored on some shelf somewhere for months and months, while the OIE BSE MRR was being born, etc, etc, the USA total figures for BSE testing in this day and time, regardless of the figures the OIE recommend, are terribly flawed, to say the least. ...
Monitoring the occurrence of emerging forms of Creutzfeldt-Jakob disease inthe United States
http://cjdusa.blogspot.com/
BSE (Mad Cow) Update:Do Reports of sCJD Clusters Matter?
snip... see full text ;
http://cjdtexas.blogspot.com/
CJD QUESTIONNAIRE
http://cjdquestionnaire.blogspot.com/
SCRAPIE USA
http://scrapie-usa.blogspot.com/
NOR-98 ATYPICAL SCRAPIE CASES USA
http://nor-98.blogspot.com/
CREUTZFELDT JAKOB DISEASE MAD COW BASE UPDATE USA
http://cjdmadcowbaseoct2007.blogspot.com/
BSE BASE MAD COW TESTING TEXAS, USA, AND CANADA, A REVIEW OF SORTS
http://madcowtesting.blogspot.com/
MADCOW USDA the untold story
http://madcowusda.blogspot.com/
USA NVCJD BLOOD RECALLS ONLY ;
http://www.google.com/search?hl=en&q=CJD+BLOOD+RECALLS+TSS&btnG=Search
vCJD case study highlights blood transfusion risk
http://vcjdblood.blogspot.com/
Transmissible Mink Encephalopathy TME
http://transmissible-mink-encephalopathy.blogspot.com/
CHRONIC WASTING DISEASE
http://chronic-wasting-disease.blogspot.com/
SEAC 99th meeting on Friday 14th December 2007
http://seac992007.blogspot.com/
Terry S. Singeltary Sr. P.O. Box 42 Bacliff, Texas USA 77518
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