Wednesday, July 16, 2008

Implementation of 2008 Feed Ban Enhancements Questions and Answers July 15, 2008

July 15, 2008

Implementation of 2008 Feed Ban Enhancements

Since the April 25, 2008 publication of the BSE final rule, Substances Prohibited from Use in Animal Food or Feed, the Food and Drug Administration (FDA) has received numerous questions pertaining to the implementation of the rule. FDA's Center for Veterinary Medicine (CVM) has posted answers to some of the most frequently asked questions concerning the feed ban. Any additional questions on this subject may be directed to:

Shannon Jordre
Division of Compliance (HFV-230)
Office of Surveillance and Compliance
Center for Veterinary Medicine
U.S. Food and Drug Administration
MPN IV Bldg., Room 113
7519 Standish Place
Rockville, MD 20855-2773
Telephone: (240) 276-9229
FAX: (240) 276-9241

Final Rule, Docket No. FDA-2002-N-0031 (formerly 2002N-0273), CVM 200646. Substances Prohibited From Use in Animal Food or Feed. Pages 22719-22758 [FR Doc. 08-1180] April 25, 2008 [TXT] [PDF] [PRE-PUB] Effective date April 27, 2009

http://www.fda.gov/OHRMS/DOCKETS/98fr/08-1180.htm


Feed Ban Enhancement: Implementation Questions and Answers, July 15, 2008

Feed Ban Enhancement: Implementation Questions and Answers July 15, 2008

The 2008 Regulation

1. Q: What changes were made to FDA’s animal feed regulations?

A: The changes to the regulations provide additional protections against bovine spongiform encephalopathy (BSE, “mad cow disease”). FDA added a new section 589.2001 to the regulations which prohibits the use of high-risk cattle material in feed for all animal species. This section builds on the 1997 BSE feed regulation at 589.2000, which remains in effect but which applies only to feed for cattle and other ruminants. Specifically, the new section 589.2001 defines the following as cattle material prohibited in animal feed (CMPAF):

the entire carcass of BSE-positive cattle

the brains and spinal cords from cattle 30 months of age and older

the entire carcass of cattle not inspected and passed for human consumption, unless the cattle are less than 30 months of age or the brains and spinal cords have been effectively removed

tallow derived from BSE-positive cattle

tallow derived from CMPAF that contains more than 0.15% insoluble impurities

mechanically separated beef derived from CMPAF

2. Q: Were any changes made to section 589.2000?

A: Yes. The definition of protein derived from mammalian tissue was changed to exclude tallow containing no more than 0.15% insoluble impurities. This means that tallow containing more than 0.15% insoluble impurities may no longer be fed to cattle and other ruminants. [See Comment 33 and 589.2000(a)(1) page 22756]

3. Q: What is the impact of the new regulation on feed manufacturers?

A: The primary impact of the 2008 rule will be on the rendering industry due to a number of specific requirements for renderers. However, feed manufacturers may be impacted by the requirement in the new rule that animal feed and feed ingredients shall not be manufactured from, processed with, or otherwise contain CMPAF. In addition, the change to section 589.2000 means that feed manufacturers will need to make sure that tallow used in ruminant feed contains not more than 0.15% insoluble impurities.

4. Q: Will the FDA provide a period of time after the effective date (like that given for the 1997 rule) to educate renderers about new requirements under the 2008 rule?

A: No. The 12-month implementation period is intended to provide sufficient time for the industry to become familiar with the requirements of the rule.

5. Q: Does the definition of CMPAF apply to material derived from livestock other than cattle?

A: No. The new rule applies only to cattle (consistent with USDA regulations, this means bos taurus, bos indicus, and bison bison) and not to other livestock species such as sheep, swine, or horses. The rule may have an indirect impact on how renderers handle other species, depending on how individual rendering companies respond to the rule.

Exclusions

6. Q: Will FDA list specific exclusions from the rule such as poultry fat, pork fat, recycled restaurant grease (from food offered for human consumption), and blood products to help prevent market disruptions?

A: No. This rule is clear in defining CMPAF and does not restrict the use of any other products in animal feed.

Implementation

7. Q: When does the new regulation go into effect?

A: The regulation becomes effective on April 27, 2009, one year after publication in the Federal Register. The 12-month implementation period allows time for the livestock, meat, rendering, and animal feed industries to adapt their practices to comply with the new regulation.

8. Q: What about feed manufactured before April 27, 2009 that contains CMPAF?

A: After April 27, 2009 it will not be legal to introduce into interstate commerce feed or feed ingredients containing CMPAF. Because the rule does not provide a grace period for using up feed made with CMPAF, it is expected that renderers and feed manufacturers will discontinue use of materials containing CMPAF in time to ensure that feed in distribution after the deadline is free of CMPAF.

9. Q: When will more detailed guidance be available for renderers, feed manufacturers and livestock producers?

A: We have started the process of developing guidance, but it will take some time to go through the formal process.

Disposal of CMPAF

10. Q: Can older dead stock cattle and byproducts from meat packing plants that slaughter older cattle still be used in animal feed for non-ruminants?

A: Yes, as long as the material is free of CMPAF.

11. Q: What is going to happen to the CMPAF that can no longer be used in animal feed?

A: A number of methods are currently available for disposing of CMPAF, including landfill, incineration, composting, alkaline hydrolysis, and burial. Another disposal option is to first render CMPAF to stabilize the material and reduce the volume, and then dispose of the rendered material by means other than use in animal feed. Whatever methods are used to dispose of CMPAF, they must comply with state and local requirements.

12. Q: Can ash from the incineration of CMPAF be used in feed?

A: No. The rule prohibits the use of CMPAF in animal feed and does not contain any provisions allowing for inactivation of BSE infectivity.

13. Q: Can CMPAF be rendered for use as fertilizer?

A: This rule does not place any restrictions on the use of CMPAF as fertilizer.

By-products from slaughter establishments

14. Q: How will renderers be assured that cattle offal received from slaughter facilities does not contain CMPAF?

A: Renderers must have records that demonstrate that establishments supplying cattle material to the renderer have adequate procedures in place to exclude CMPAF. These records will be considered sufficient if they include certification or other documentation from the supplier that material supplied to the renderer does not contain CMPAF, or documentation of another method acceptable to FDA, such as third-party certification. [See Section C page 22735]

15. Q: What does an acceptable certification consist of?

A: Certification is acceptable, provided it includes a description of the supplier’s segregation procedures, documentation that the supplier confirms that its segregation procedures were in place prior to supplying any cattle material to the renderer, and records of the renderer’s periodic review of the suppliers’ certification or documentation of another method acceptable to FDA, such as a third party certification, for verifying that suppliers have effectively excluded CMPAF. [Section C page 22735]

16. Q: The rule requires periodic review of the suppliers’ certification. How often is periodic?

A: The rule does not specify a frequency.

17. Q: A firm’s written procedures are typically proprietary, so how extensive does the description of procedures need to be?

A: The rule does not specify how detailed the description must be. However, with respect to cattle materials obtained from establishments which have segregated CMPAF, such records must demonstrate that those establishments supplying cattle materials to the renderer have adequate procedures in place to effectively exclude CMPAF.

18. Q: How does FDA expect renderers to review the suppliers’ certification or other documentation? Will certification renewal be adequate? Does FDA expect renderers to audit supplier documents and procedures – such access will most likely be denied and FDA has limited authority over such suppliers?

A: The rule does not specify the requirements of a review.

19. Q: Who is responsible if it is determined that CMPAF was not excluded from slaughter offal used to produce MBM for animal feed use?

A: Although all parties are expected to exercise due diligence in excluding CMPAF, the rule places the responsibility on the renderer.

20. Q: Will a renderer be responsible for a recall if a supplier of raw material did not remove CMPAF?

A: If it is determined that material rendered for animal feed use contains CMPAF and a recall is necessary, the renderer would be responsible for conducting the recall. However, establishing liability for the cost of the recall should not be different than for other customer/supplier business relationships.

21. Q: How will the new rule be enforced at small slaughtering facilities?

A: Inspections will not be conducted at any slaughter establishments, regardless of size. Inspections will be conducted at rendering facilities to verify that the renderer has determined that CMPAF is being excluded from inedible raw materials supplied by slaughter establishments.

22. Q: Are all specified risk materials (SRMs) required to be separated, or just the brains and spinal cords from cattle over 30 months?

A: The rule requires separation of those materials defined by the rule as CMPAF. In a slaughter facility, this means the brain and spinal cord from any animal over 30 months of age. As explained in the preamble to the 2008 rule, FDA does not believe it is necessary to prohibit from use in feed for non-ruminants any other tissues defined elsewhere (e.g. by OIE or USDA) as SRMs.

23. Q: Does the rule require suppliers of raw material to renderers to be trained and certified on handling their CMPAF?

A: No. FDA intends to provide outreach explaining the requirements of the rule, but does not intend to provide training to the private sector.

24. Q: What items specifically will not be accepted by renderers as a result of this new rule?

A: The rule does not prohibit a renderer from accepting any of the items they may currently be accepting; the rule prohibits the rendering of CMPAF for use in animal feed. Individual rendering establishments will determine what they choose to accept for further processing. A renderer may choose to collect CMPAF for disposal, as a service to slaughter establishments.

25. Q: Will the FDA develop a standard report to be used in recording CMPAF and/or non-CMPAF material from various sources? It would be helpful if all suppliers and all renderers use the same form for supplier certification.

A: No. FDA will not be developing a standard form, but the rule does not prevent a standard form from being used if industry chooses to develop one.

State-Inspected and Custom Slaughter Facilities

26. Q: Are cattle that are slaughtered in state-inspected facilities eligible for rendering for feed use?

A: Yes. 21 FR 589.2001(b)(2) defines “cattle not inspected and passed for human consumption” as cattle that did not pass antemortem inspection by the appropriate regulatory authority. In a state-inspected slaughter facility the state is the appropriate regulatory authority and animals that pass antemortem inspection may be rendered for use in animal feed provided that other requirements of the rule, such as removal of brain and spinal cord from animals over 30 months of age, are met.

27. Q: Can cattle offal from uninspected (custom) slaughter be rendered for feed use?

A: Yes. Cattle slaughtered under custom slaughter meet the definition of “cattle not inspected and passed for human consumption”. Therefore, offal from custom slaughter operations may be rendered for feed use if the brain and spinal cord from cattle older than 30 months are excluded from the offal. Just as they would for an inspected slaughter establishment, renderers receiving material from a custom slaughter operation would need records that demonstrate that the establishment has adequate procedures in place to exclude CMPAF. [See comments 38 and 57]

Determining Age of Cattle

28. Q: How will renderers determine and document the age of cattle not inspected and passed for human consumption (e.g., dead stock cattle) that are collected to be rendered for feed use?

A: Renderers are required to maintain written procedures for specifying how they either remove brain and spinal cord from cattle not inspected and passed for human consumption, or how they separate such animals based on whether they are 30 months of age or older. Written procedures must be made available for FDA inspection. FDA intends to provide guidance on this issue. [See 589.2001(c)(2)(ii) and comments 30 and 40]

29. Q: What are acceptable procedures for determining the age of cattle?

A: As discussed in the preamble to this rule, FDA received a number of suggestions for ways to determine the age of cattle, including animal identification systems, dairy herd records, dentition, body weight, or feedlot origin. The rule requires only that renderers have written procedures explaining how they determine the age of cattle they process as well as records documenting their compliance with the requirement. It does not mandate the use of a specific method of determining the age of the cattle. FDA intends to provide guidance on this issue. [See 589.2001(c)(2)(ii) and comments 30 and 40]

30. Q: Can renderers accept farmer statements based on production records?

A: Yes, as long as the records meet the requirements in 589.2001(c)(3)(i) (A) or (B).

31. Q: What kinds of written documentation for age verification will be acceptable? Will a handwritten note, signed and dated by the owner, suffice?

A: Nothing in the rule prevents this form of documentation if it meets the requirements in 589.2001(c)(3)(i) (A) or (B).

32. Q: Will renderers be held liable for mistakes in statements of age?

A: Although all parties are expected to exercise due diligence in complying with the rule, the rule places the responsibility on the renderer. The renderer is expected to have procedures in place that will minimize the potential for mistakes. For example, a renderer may wish to use dentition to confirm that the producer’s statement is correct. [See comment 28, comment 40; also 589.2001(c)(2)(ii) and 589.2001(c)(3)(i)]

33. Q: Will dentition be accepted as a determinant of age of cattle?

A: Nothing in the rule prevents the use of dentition as a method for determining the age of cattle. We are aware that under USDA procedures for using dentition, cattle are considered to be 30 months of age or older if at least one of the second set of permanent incisors has erupted through the gum line. [See Comment 40]

34. Q: Will renderers be required to provide training on using dentition to determine the age of cattle?

A: No.

35. Q: Can a renderer accept an annual statement of age (such as an affidavit) from a feedlot certifying that dead stock coming from their facility are all under 30 months of age?

A: Nothing in the rule prevents this type of documentation if it meets the requirements in 589.2001(c)(3)(i) (A) or (B).

Removing brain and spinal cord from dead stock cattle

36. Q: How will FDA determine that renderers are adequately removing brain and spinal cord, and will FDA have a zero tolerance for central nervous system tissue?

A: FDA has a variety of means for determining whether renderers are in compliance with the requirements in the 2008 rule, including reviewing renderers’ written procedures, and observing the procedures being used while the facility is operating. With respect to adequacy of brain and spinal cord removal, the rule contains no provision allowing residual brain and spinal cord tissue in material from cattle 30 months of age or older. FDA intends to provide guidance on this issue. [See 589.2001(c)(2)(ii), 589.2001(c)(3)(i), 589.2001(e)]

37. Q: What methods are acceptable for removing brain and spinal cord from dead cattle over 30 months of age?

A: The rule does not specify what method or methods may be used. FDA intends to provide guidance on this issue. [See Comment 18]

38. Q: Can renderers use vacuum as a means of removal of brain and spinal cord from dead cattle?

A: Yes, provided the renderer has determined that the method is effective.

39. Q: Can renderers use direct removal (using saw to open scull and splitting carcass) from dead cattle?

A: Yes, provided the renderer has determined that the method is effective.

40. Q: Does the definition of CMPAF include the dorsal root ganglia?

A: No.

41. Q: Can the vertebral column be rendered for animal feed use if the spinal cord is removed?

A: Yes. [See Comment 31]

42. Q: Can renderers that harvest skeletal muscle and hides from dead cattle (4-D operations) continue to remove skeletal muscle from cattle carcasses to supply to mink farms and/or greyhound kennels?

A: Yes. Skeletal muscle contains no CMPAF and therefore could be removed from the carcass and used in feed for non-ruminant animals, including food for pets or mink. However, under the rule 4-D operations meet the definition of a renderer and are therefore required to ensure that CMPAF from the remainder of the carcass is properly excluded from animal feed. Such operations are also required to have written procedures in place describing the processes they use to comply with the rule. [See Comment 30]

43. Q: What does “or otherwise effectively excluded from animal feed” mean?

A: The phrase was intended to describe operations where the animal feed (e.g., skeletal muscle for pets or mink) is removed from the CMPAF (i.e. the remainder of the carcass containing the brain and spinal cord), as opposed to operations that remove the CMPAF (brain and spinal cord) so that the remaining material may be used in animal feed. “Removal of brain and spinal cord” does not accurately describe the first type of operation. [See 589.2001(c)(2)(ii) and comments 30 and 40.]

44. Q: Can renderers collect offal from 4-D operations and other renderers?

A: Yes. Both parties would have the same obligations to ensure that CMPAF is excluded from animal feed. [See Comments 30 and 57]

Dedicated equipment/transportation

45. Q: Can the same receiving and processing equipment be used for CMPAF and non-CMPAF materials?

A: No. The rule requires the use of either separate equipment or separate containers for CMPAF that has been separated from non-CMPAF materials. [See 589.2001(c)(2)(iii)(A) & (B)]

46. Q: On a truck, do dead cattle over 30 months of age have to be physically separated from dead cattle under 30 months of age?

A: No. The rule only requires separate equipment or containers once the CMPAF has been separated from non-CMPAF.

47. Q: Can CMPAF be hauled on the same truck as slaughter offal intended to be used in animal feed if it is in a separate container or compartment?

A: Yes, provided there is no cross-contamination between containers or compartments.

Tallow

Table 1

Source of Tallow Insoluble Impurities

Level Feed Use Caution Statement Required Regulation

any source (non-CMPAF or CMPAF) = 0.15% allowed in all animal feeds None 21 CFR 589.2000 and 589.2001

non-CMPAF 0.15% allowed in all but ruminant feeds “do not feed to cattle or other ruminants” 589.2000

CMPAF 0.15% not allowed in animal feed “do not feed to animals” 589.2001

48. Q: Where did the 0.15% insoluble impurity standard come from?

A: The 0.15% level is an internationally recognized standard for trade in tallow. The World Organization for Animal Health (OIE), in the BSE Chapter of the Terrestrial Animal Health Code, has defined protein free tallow as tallow containing no more than 0.15% insoluble impurities.

49. Q: Does all tallow (animal fat originating from cattle) need to contain no more than 0.15% insoluble impurities to be used as a feed ingredient?

A: Tallow containing more than 0.15% insoluble impurities may not be used in ruminant feed but may be used in feed for non-ruminants. Tallow is prohibited in all animal feed only if it contains more than 0.15% insoluble impurities and is derived from rendering CMPAF. See Table 1.

50. Q: Is the caution statement needed on tallow containing more than 0.15% insoluble impurities?

A: Yes. Tallow must bear the caution statement “do not feed to cattle or other ruminants if it contains more than 0.15% insoluble impurities. If it is derived from rendering CMPAF and contains more than 0.15% insoluble impurities, it must bear the caution statement “do not feed to animals”. See Table 1.

51. Q: Does the 0.15% impurity standard apply to recycled restaurant grease?

A: FDA intends to provide guidance that will address this question.

52. Q: Can tallow derived from CMPAF containing more than 0.15% insoluble impurities be blended to meet the 0.15% insoluble impurities limit?

A: There is no provision in the rule to allow blending to be used to meet the 0.15% insoluble impurity limit.

53. Q: Will clean-out/flush-out or sequencing procedures be required if common pipelines are used to load-out fats having levels of impurities above and below 0.15%?

A: Tallow obtained from rendering CMPAF is itself CMPAF if it contains more than 0.15% insoluble impurities. Equipment or containers for such tallow must therefore be separate from equipment or containers used for ingredients for animal feed. In addition, the change to section 589.2000 means that tallow containing more than 0.15% insoluble impurities is mammalian protein prohibited for use in ruminant feed. Section 589.2000 requires that renderers provide for measures to avoid comingling or cross-contamination by either maintaining separate equipment or facilities, or by using cleanout procedures or other means adequate to prevent carryover. Therefore, separation or other means such as cleaning, flushing, or sequencing is needed between tallow containing more than 0.15% insoluble impurities, and tallow that may be used in feed for ruminants.

54. Q: Is there an analytical method for determining the amount of insoluble impurities in tallow?

A: Yes. The rule specifies that insoluble impurities must be measured by the method entitled “Insoluble Impurities” (AOCS Method Ca 3a-46), American Oil Chemist’s Society (AOCS), 5th Edition, 1997, or another method equivalent in accuracy, precision, and sensitivity to this method. A copy of the method may be obtained from the AOCS (http://www.aocs.org/), or viewed at the FDA Center for Food Safety and Applied Nutrition’s Library or at the National Archives and Records Administration. [See 589.2001(b)(1)(vi)(B)]

55. Q: What is the analytical variation (AV) for samples analyzed using the AOCS method? AAFCO does not list an acceptable analytical variation (AV) for insoluble impurities. Will acceptable variation for comparing results from different labs be developed? Will FDA verify suitability of labs, methods used, and results?

A: At this time, FDA is not aware that an AV has been established. FDA welcomes any information indicating that variation in test results is presenting difficulties in establishing that tallow meets the impurity standard. Firms using methods other than the AOCS method must have data or other information showing that the method is equivalent in accuracy, precision, and sensitivity to the AOCS method.

Import and Export of Animal Proteins

56. Q: Are animal proteins being imported into the US from other countries required to have CMPAF removed?

A: Yes, unless the exporting country has been designated as exempt from the requirement. The rule contains a provision allowing countries to apply for such an exemption. Any country seeking such a designation would have to provide sufficient scientific evidence to support its claimed BSE risk status. [See 589.2001(b)(1)(vi)(C) and 589.2001(f)]

57. Q: Will CMPAF removal also be required for ruminant protein meals destined for export?

A: Feed containing CMPAF intended for export is not deemed to be adulterated or misbranded if it complies with the requirements of section 801(e)(1) of the Federal Food, Drug, and Cosmetic Act.

Compliance

58. Q: Will FDA clarify consequences for failure in age determination or brain/spinal cord removal?

A: FDA’s enforcement response for failing to comply with this rule will be consistent with enforcement responses used for non-compliance with other FDA regulations. These consequences could include opportunity to make immediate correction, warning letter, seizure, injunction and criminal penalties.

59. Q: Will FDA continue to use the designations NAI, VAI and OAI to categorize renderer compliance with the new rule?

A. Yes.

Recall

60. Q: Will a recall be required if it is determined that a renderer did not properly remove brain and spinal cord from dead cattle, or a slaughter establishment did not properly segregate CMPAF from slaughter offal, even if all parties involved made good faith efforts to comply?

A: Decisions to require recalls are made on a case-by-case basis.

61. Q: Would recalls concerning CMPAF be Class II or Class III?

A: Classification of a recall depends on the circumstances of an individual case. Records

62. Q: How long are records required to be kept?

A: The rule requires that records be kept for one year. [See 589.2001(e)]

63. Q: Are electronic records acceptable for meeting the one year record-keeping requirement, or is it necessary to maintain the original documents?

A: Documents may be stored electronically. However, as with hard copies, electronic records must still be made available for inspection and copying, if necessary, at the time and location of the inspection.

64. Q: What does “track CMPAF to ensure the materials are not introduced into animal feed” mean? Are renderers responsible beyond giving up control of the material?

A: FDA intends provide guidance on this issue.

Marking

65. Q: What are the marking requirements in the new rule?

A: The rule requires that once CMPAF has been separated from other cattle materials, renderers mark CMPAF with an agent that can be readily detected on visual inspection. This requirement is intended to prevent cross-contamination, and as explained in the preamble to the 2008 rule, is also intended to provide a readily detectable method by which all persons in the animal feed chain can be made aware that the product is prohibited material or contains prohibited material. [See Requirements B(1) page 22735]

66. Q: If CMPAF is rendered to obtain tallow, shouldn’t the finished meal be marked/dyed rather than the raw CMPAF? Marking the raw CMPAF will cause the tallow to be marked as CMPAF when, if it contains less than 0.15% insoluble impurities, it is not CMPAF.

A: FDA intends to provide guidance on this issue.



http://www.fda.gov/cvm/bse_QA.htm


http://www.fda.gov/cvm/CVM_Updates/CVMupdate_Feedban.htm



Greetings,

IT would seem very disturbing that in July 2008, we are still even talking about these failed rules and regulations. no mad cows in the USA, no cjd in humans in the USA, and we have the safest beef in the world. not!

TSS



NEW SOLUTIONS: A Journal of Environmental and Occupational Health Policy

Issue: Volume 18, Number 2 / 2008 Pages: 145 - 156 URL: Linking Options

Mad Cows and Computer Models: The U.S. Response to BSE

Frank Ackerman and Wendy A. Johnecheck

Abstract:

The proportion of slaughtered cattle tested for BSE is much smaller in the U.S. than in Europe and Japan, leaving the U.S. heavily dependent on statistical models to estimate both the current prevalence and the spread of BSE. We examine the models relied on by USDA, finding that the prevalence model provides only a rough estimate, due to limited data availability. Reassuring forecasts from the model of the spread of BSE depend on the arbitrary constraint that worst-case values are assumed by only one of 17 key parameters at a time. In three of the six published scenarios with multiple worst-case parameter values, there is at least a 25% probability that BSE will spread rapidly. In public policy terms, reliance on potentially flawed models can be seen as a gamble that no serious BSE outbreak will occur. Statistical modeling at this level of abstraction, with its myriad, compound uncertainties, is no substitute for precautionary policies to protect public health against the threat of epidemics such as BSE.

http://baywood.metapress.com/app/home/contribution.asp?referrer=parent&backto=issue,5,18;journal,1,41;linkingpublicationresults,1:300327,1



Owner and Corporation Plead Guilty to Defrauding Bovine Spongiform Encephalopathy (BSE) Surveillance Program

An Arizona meat processing company and its owner pled guilty in February 2007 to charges of theft of Government funds, mail fraud, and wire fraud. The owner and his company defrauded the BSE Surveillance Program when they falsified BSE Surveillance Data Collection Forms and then submitted payment requests to USDA for the services. In addition to the targeted sample population (those cattle that were more than 30 months old or had other risk factors for BSE), the owner submitted to USDA, or caused to be submitted, BSE obex (brain stem) samples from healthy USDA-inspected cattle. As a result, the owner fraudulently received approximately $390,000. Sentencing is scheduled for May 2007.

snip...

Topics that will be covered in ongoing or planned reviews under Goal 1 include:

soundness of BSE maintenance sampling (APHIS),

implementation of Performance-Based Inspection System enhancements for specified risk material (SRM) violations and improved inspection controls over SRMs (FSIS and APHIS),

snip...

The findings and recommendations from these efforts will be covered in future semiannual reports as the relevant audits and investigations are completed.

4 USDA OIG SEMIANNUAL REPORT TO CONGRESS FY 2007 1st Half

http://www.usda.gov/oig/webdocs/sarc070619.pdf



-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 Meats 2 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



Thu Dec 6, 2007 11:38

FDA IN CRISIS MODE, AMERICAN LIVES AT RISK

http://www.cidrap.umn.edu/cidrap/content/fs/food-disease/news/dec0407fda.html



FDA SCIENCE AND MISSION AT RISK

http://www.fda.gov/ohrms/dockets/ac/07/briefing/2007-4329b_02_01_FDA%20Report%20on%20Science%20and%20Technology.pdf



In 2007, in one weekly enforcement report, the fda recalled 10,000,000+ pounds of BANNED MAD COW FEED, 'in commerce', and i can tell you that most of it was fed out ;

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 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

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



Subject: MAD COW FEED RECALL USA SEPT 6, 2006 1961.72 TONS IN COMMERCE AL, TN, AND WV Date: September 6, 2006 at 7:58 am PST

snip... see listings and references of enormous amounts of banned mad cow protein 'in commerce' in 2006 and 2005 ;

see full text ;

Friday, April 25, 2008

Substances Prohibited From Use in Animal Food or Feed [Docket No. 2002N-0273] (Formerly Docket No. 02N-0273) RIN 0910-AF46

http://madcowfeed.blogspot.com/2008/04/substances-prohibited-from-use-in.html



Missouri Firm Recalls Cattle Heads That Contain Prohibited Materials

Recall Release CLASS II RECALL FSIS-RC-021-2008 HEALTH RISK: LOW

Congressional and Public Affairs (202) 720-9113 Amanda Eamich

WASHINGTON, June 26, 2008 – Paradise Locker Meats, a Trimble, Mo., establishment, is voluntarily recalling approximately 120 pounds of fresh cattle heads with tonsils not completely removed, which is not compliant with regulations that require the removal of tonsils from cattle of all ages, the U.S. Department of Agriculture’s Food Safety and Inspection Service announced today.

Tonsils are considered a specified risk material (SRM) and must be removed from cattle of all ages in accordance with FSIS regulations. SRMs are tissues that are known to contain the infective agent in cattle infected with BSE, as well as materials that are closely associated with these potentially infective tissues. Therefore, FSIS prohibits SRMs from use as human food to minimize potential human exposure to the BSE agent.

The products subject to recall include: Boxes of “BEEF HEAD, PARADISE LOCKER MEATS.” Each shipping package bears the establishment numbers “EST. 31865” inside the USDA mark of inspection.

These products were sent to retail establishments and restaurants in the Kansas City, Kansas, area.

The problem was discovered through routine FSIS inspection that verified there had been incomplete removal of the tonsils by the recalling establishment.

Media and consumers with questions about the recall should contact company Production Supervisor Louis Fantasma at (816) 370-6328.

Consumers with food safety questions can “Ask Karen,” the FSIS virtual representative available 24 hours a day at AskKaren.gov. The toll-free USDA Meat and Poultry Hotline 1-888-MPHotline (1-888-674-6854) is available in English and Spanish and can be reached from l0 a.m. to 4 p.m. (Eastern Time) Monday through Friday. Recorded food safety messages are available 24 hours a day. #

http://www.fsis.usda.gov/News_&_Events/Recall_021_2008_Release/index.asp



Texas Firm Recalls Cattle Heads That Contain Prohibited Materials

Recall Release CLASS II RECALL FSIS-RC-020-2008 HEALTH RISK: LOW

Congressional and Public Affairs (202) 720-9113 Peggy Riek

WASHINGTON, June 26, 2008 – Beltex Corporation, doing business as Frontier Meats, a Fort Worth, Texas, establishment, is recalling approximately 2,850 pounds of fresh cattle heads which may contain specified risk materials (SRMs), the U.S. Department of Agriculture’s Food Safety and Inspection Service announced today.

SRMs are tissues that are known to contain the infective agent in cattle infected with BSE, as well as materials that are closely associated with these potentially infective tissues. Therefore, FSIS prohibits SRMs from use as human food to minimize potential human exposure to the BSE agent.

The products subject to recall include: Cases of "BEEF WHOLE HEAD." Each shipping package bears the establishment number "EST. 7041B" inside the USDA mark of inspection, as well as a package code of "51904" or "63922."

The company is recalling all products packed between May 31, 2007, and June 24, 2008. These products were distributed to retail establishments and lunch carts in the Dallas-Ft. Worth, Texas, area.

The problem was discovered by the State of Texas officials during a routine inspection at a retail establishment.

Media and consumers with questions about the recall should contact the company Sales Department at (817) 624-1136.

Consumers with food safety questions can “Ask Karen,” the FSIS virtual representative available 24 hours a day at AskKaren.gov. The toll-free USDA Meat and Poultry Hotline 1-888-MPHotline (1-888-674-6854) is available in English and Spanish and can be reached from l0 a.m. to 4 p.m. (Eastern Time) Monday through Friday. Recorded food safety messages are available 24 hours a day.

#

http://www.fsis.usda.gov/News_&_Events/Recall_020_2008_Release/index.asp



Thursday, June 26, 2008

Texas Firm Recalls Cattle Heads That Contain Prohibited Materials

http://madcowfeed.blogspot.com/2008/06/texas-firm-recalls-cattle-heads-that.html



Tuesday, May 27, 2008

FDA BSE/Ruminant Feed Inspections Firms Inventory Report Texas Legend Ranch OAI 05/10/2008

http://madcowfeed.blogspot.com/2008/05/fda-bseruminant-feed-inspections-firms.html



SPECIFIED RISK MATERIALS SRMs

http://madcowspontaneousnot.blogspot.com/2008/02/specified-risk-materials-srm.html



SRM MAD COW RECALL 406 THOUSAND POUNDS CATTLE HEADS WITH TONSILS KANSAS

http://cjdmadcowbaseoct2007.blogspot.com/2008/04/srm-mad-cow-recall-406-thousand-pounds.html



Tuesday, July 1, 2008

Missouri Firm Recalls Cattle Heads That Contain Prohibited Materials SRMs

http://madcowfeed.blogspot.com/2008/07/missouri-firm-recalls-cattle-heads-that.html


Wednesday, July 9, 2008 [Docket No. FDA-2008-N-0369] Ruminant Feed Ban Support Project; ``Response to RFA-FDA-08-008''

http://madcowfeed.blogspot.com/2008/07/docket-no-fda-2008-n-0369-ruminant-feed.html



MAD COW DISEASE terminology UK c-BSE (typical), atypical BSE H or L, and or Italian L-BASE

http://bse-atypical.blogspot.com/2008/03/mad-cow-disease-terminology-uk-c-bse.html



Please remember, the last two mad cows documented in the USA i.e. Alabama and Texas, both were of the 'atypical' BSE strain, and immediately after that, the USDA shut down the testing from 470,000 to 40,000 in the U.S. in 2007 out of about 35 million cattle slaughtered. also, science is showing that some of these atypical cases are more virulent to humans than the typical UK BSE strain ;

***Atypical forms of BSE have emerged which, although rare, appear to be more virulent than the classical BSE that causes vCJD.***

Progress Report from the National Prion Disease Pathology Surveillance Center

An Update from Stephen M. Sergay, MB, BCh & Pierluigi Gambetti, MD

April 3, 2008

http://www.aan.com/news/?event=read&article_id=4397&page=72.45.45



In this context, a word is in order about the US testing program. After the discovery of the first (imported) cow in 2003, the magnitude of testing was much increased, reaching a level of >400,000 tests in 2005 (Figure 4). Neither of the 2 more recently indigenously infected older animals with nonspecific clinical features would have been detected without such testing, and neither would have been identified as atypical without confirmatory Western blots. Despite these facts, surveillance has now been decimated to 40,000 annual tests (USDA news release no. 0255.06, July 20, 2006) and invites the accusation that the United States will never know the true status of its involvement with BSE.

In short, a great deal of further work will need to be done before the phenotypic features and prevalence of atypical BSE are understood. More than a single strain may have been present from the beginning of the epidemic, but this possibility has been overlooked by virtue of the absence of widespread Western blot confirmatory testing of positive screening test results; or these new phenotypes may be found, at least in part, to result from infections at an older age by a typical BSE agent, rather than neonatal infections with new "strains" of BSE. Neither alternative has yet been investigated.

http://www.cdc.gov/ncidod/EID/vol12no12/06-0965.htm



Cases of atypical BSE have only been found in countries having implemented large active surveillance programs. As of 1st September 2007, 36 cases (16 H, 20 L) have been described all over the world in cattle: Belgium (1 L) [23], Canada (1 H)15, Denmark (1 L)16, France (8 H, 6 L)17, Germany (1 H, 1 L) [13], Italy (3 L)18, Japan (1 L) [71], Netherlands (1 H, 2 L)19, Poland (1 H, 6 L)20, Sweden (1 H)21, United Kingdom (1 H)22, and USA (2 H)23. Another H-type case has been found in a 19 year old miniature zebu in a zoological park in Switzerland [56]. It is noteworthy that atypical cases have been found in countries that did not experience classical BSE so far, like Sweden, or in which only few cases of classical BSE have been found, like Canada or the USA.

And last but not least, similarities of PrPres between Htype BSE and human prion diseases like CJD or GSS have been put forward [10], as well as between L-type BSE and CJD [17]. These findings raise questions about the origin and inter species transmission of these prion diseases that were discovered through the BSE active surveillance.

full text 18 pages ;

http://www.vetres.org/index.php?option=article&access=standard&Itemid=129&url=/articles/vetres/pdf/2008/04/v07232.pdf



EFSA Scientific Report on the Assessment of the Geographical BSE-Risk (GBR) of the United States of America (USA)

Summary of the Scientific Report

The European Food Safety Authority and its Scientific Expert Working Group on the Assessment of the Geographical Bovine Spongiform Encephalopathy (BSE) Risk (GBR) were asked by the European Commission (EC) to provide an up-to-date scientific report on the GBR in the United States of America, i.e. the likelihood of the presence of one or more cattle being infected with BSE, pre-clinically as well as clinically, in USA. This scientific report addresses the GBR of USA as assessed in 2004 based on data covering the period 1980-2003.

The BSE agent was probably imported into USA and could have reached domestic cattle in the middle of the eighties. These cattle imported in the mid eighties could have been rendered in the late eighties and therefore led to an internal challenge in the early nineties. It is possible that imported meat and bone meal (MBM) into the USA reached domestic cattle and leads to an internal challenge in the early nineties.

A processing risk developed in the late 80s/early 90s when cattle imports from BSE risk countries were slaughtered or died and were processed (partly) into feed, together with some imports of MBM. This risk continued to exist, and grew significantly in the mid 90’s when domestic cattle, infected by imported MBM, reached processing. Given the low stability of the system, the risk increased over the years with continued imports of cattle and MBM from BSE risk countries.

EFSA concludes that the current GBR level of USA is III, i.e. it is likely but not confirmed that domestic cattle are (clinically or pre-clinically) infected with the BSE-agent. As long as there are no significant changes in rendering or feeding, the stability remains extremely/very unstable. Thus, the probability of cattle to be (pre-clinically or clinically) infected with the BSE-agent persistently increases.

http://www.efsa.europa.eu/en/science/tse_assessments/gbr_assessments/573.html


http://www.efsa.europa.eu/etc/medialib/efsa/science/tse_assessments/gbr_assessments/573.Par.0004.File.dat/sr03_biohaz02_usa_report_v2_en1.pdf


Wednesday, June 11, 2008

OIE Recognition of the BSE Status of Members RESOLUTION No. XXI (Adopted by
the International Committee of the OIE on 27 May 2008)

http://usdavskorea.blogspot.com/2008/06/oie-recognition-of-bse-status-of.html


http://organicconsumers.org/forum/index.php?showtopic=1566


PLEASE NOTE IN REFERENCE TO THE LATEST LONG TERM USDA DOWNER COW SCHOOL LUNCH PROGRAM CASE STUDY FOR VCJD IN CHILDREN UK AND USA

Creutzfeldt-Jakob Disease (Variant) and Bovine Spongiform Encephalopathy (Prion Diseases) Description Since 1996, strong evidence has accumulated for a causal relationship between ongoing outbreaks, primarily in Europe, of a disease in cattle called bovine spongiform encephalopathy (BSE, or "mad cow disease") and a disease in humans called variant Creutzfeldt-Jakob disease (vCJD). Both disorders, which are caused by an unconventional transmissible agent, are invariably fatal brain diseases with incubation periods typically measured in years (1). Transmission of the BSE agent to humans, leading to vCJD, is believed to occur via ingestion of cattle products contaminated with the BSE agent; the specific foods associated with this transmission are unknown. However, a recently published case-control study involving 132 vCJD cases in the United Kingdom (UK) showed evidence of an increased risk for vCJD associated with the frequency of consuming beef products likely to contain mechanically recovered meat and head meat (such as burgers, meat pies, and sausages) (2). Bioassays and molecular tests have enabled identification of what World Health Organization consultants have classified as "high-infectivity" and "lower infectivity" tissues of cattle with BSE (3). The high-infectivity tissues include the brain, spinal cord, retina, optic nerve, and dorsal root and trigeminal ganglia, suggesting that these tissues can pose a relatively high risk of transmission. The lower infectivity tissues include peripheral nerves (e.g., sciatic and facial nerves), tonsils, nictitating membrane (third eye lid), distal ileum, bone marrow, and possibly thigh muscle. The latter tissue from one cow with BSE transmitted disease to highly BSE-sensitive transgenic mice at a rate indicative of trace levels of infectivity.

http://wwwn.cdc.gov/travel/yellowBookCh4-VariantPrions.aspx

Thursday, February 21, 2008
TRANSCRIPT: Technical Briefing - Hallmark/Westland Meat Packing Company - (02/21/08)
Release No. 0054.08

http://downercattle.blogspot.com/2008/02/transcript-technical-briefing.html

FULL HISTORY OF USDA CERTIFIED DEAD STOCK DOWNER COW SCHOOL LUNCH PROGRAM

http://downercattle.blogspot.com/


Over the next 8-10 weeks, approximately 40% of all the adult mink on the farm died from TME. Since previous incidences of TME were associated with common or shared feeding practices, we obtained a careful history of feed ingredients used over the past 12-18 months. The rancher was a "dead stock" feeder using mostly (>95%) downer or dead dairy cattle and a few horses. Sheep had never been fed.

http://www.bseinquiry.gov.uk/files/mb/m09/tab05.pdf


CJD TEXAS (cjd clusters)

http://cjdtexas.blogspot.com/



USA WRITTEN CJD QUESTIONNAIRE ???

http://cjdquestionnaire.blogspot.com/



The statistical incidence of CJD cases in the United States has been revised to reflect that there is one case per 9000 in adults age 55 and older. Eighty-five percent of the cases are sporadic, meaning there is no known cause at present.

http://www.cjdfoundation.org/fact.html



Thursday, July 10, 2008
A Novel Human Disease with Abnormal Prion Protein Sensitive to Protease update July 10, 2008

http://cjdmadcowbaseoct2007.blogspot.com/2008/07/novel-human-disease-with-abnormal-prion.html



Thursday, July 10, 2008
A New Prionopathy update July 10, 2008

http://cjdmadcowbaseoct2007.blogspot.com/2008/07/new-prionopathy-update-july-10-2008.html



NOT to forget the 5 cases of the NOR-98 atypical scrapie documented in the USA in 2007, in five different states. WHICH pathologically looks like some sub-types of sporadic CJD, of which Stanely Prusiner warns of a public health risk ;

***The pathology features of Nor98 in the cerebellum of the affected sheep showed similarities with those of sporadic Creutzfeldt-Jakob disease in humans.

http://www.prion2007.com/pdf/Prion%20Book%20of%20Abstracts.pdf


Here we report that both Nor98 and discordant cases, including three sheep homozygous for the resistant PrPARR allele (A136R154R171), efficiently transmitted the disease to transgenic mice expressing ovine PrP, and that they shared unique biological and biochemical features upon propagation in mice. These observations support the view that a truly infectious TSE agent, unrecognized until recently, infects sheep and goat flocks and may have important implications in terms of scrapie control and public health.

Edited by Stanley B. Prusiner, University of California, San Francisco, CA, and approved September 12, 2005 (received for review March 21, 2005)

http://www.pnas.org/cgi/content/abstract/0502296102v1


Tuesday, June 3, 2008 SCRAPIE USA UPDATE JUNE 2008 NOR-98 REPORTED PA

http://nor-98.blogspot.com/2008/06/scrapie-usa-update-june-2008-nor-98.html


NOR-98 ATYPICAL SCRAPIE 5 cases documented in USA in 5 different states USA 007

http://nor-98.blogspot.com/2008/04/seac-spongiform-encephalopathy-advisory.html


http://nor-98.blogspot.com/


SCRAPIE USA

http://scrapie-usa.blogspot.com/


Monday, June 30, 2008

Risk behaviors in a rural community with a known point-source exposure to chronic wasting disease

please see additional comments and other studies ;

http://chronic-wasting-disease.blogspot.com/2008/06/risk-behaviors-in-rural-community-with.html

http://organicconsumers.org/forum/index.php?showtopic=1659

CWD

http://chronic-wasting-disease.blogspot.com/


JOURNAL OF NEUROLOGY

MARCH 26, 2003

RE-Monitoring the occurrence of emerging forms of Creutzfeldt-Jakob disease in the United States

Email Terry S. Singeltary:

[log in to unmask]

I lost my mother to hvCJD (Heidenhain Variant CJD). I would like to comment on the CDC's attempts to monitor the occurrence of emerging forms of CJD. Asante, Collinge et al [1] have reported that BSE transmission to the 129-methionine genotype can lead to an alternate phenotype that is indistinguishable from type 2 PrPSc, the commonest sporadic CJD. However, CJD and all human TSEs are not reportable nationally. CJD and all human TSEs must be made reportable in every state and internationally. I hope that the CDC does not continue to expect us to still believe that the 85%+ of all CJD cases which are sporadic are all spontaneous, without route/source. We have many TSEs in the USA in both animal and man. CWD in deer/elk is spreading rapidly and CWD does transmit to mink, ferret, cattle, and squirrel monkey by intracerebral inoculation. With the known incubation periods in other TSEs, oral transmission studies of CWD may take much longer. Every victim/family of CJD/TSEs should be asked about route and source of this agent. To prolong this will only spread the agent and needlessly expose others. In light of the findings of Asante and Collinge et al, there should be drastic measures to safeguard the medical and surgical arena from sporadic CJDs and all human TSEs. I only ponder how many sporadic CJDs in the USA are type 2 PrPSc?

http://www.neurology.org/cgi/eletters/60/2/176#535


sporadic CJD, the big lie

http://lists.ifas.ufl.edu/cgi-bin/wa.exe?A2=ind0705&L=sanet-mg&T=0&P=25276


THE PATHOLOGICAL PROTEIN

Hardcover, 304 pages plus photos and illustrations. ISBN 0-387-95508-9

June 2003

BY Philip Yam

CHAPTER 14 LAYING ODDS

Answering critics like Terry Singeltary, who feels that the U.S. under- counts CJD, Schonberger conceded that the current surveillance system has errors but stated that most of the errors will be confined to the older population.

http://www.thepathologicalprotein.com/


The Lancet Infectious Diseases 2003; 3:463
DOI:10.1016/S1473-3099(03)00715-1

Newsdesk

Tracking spongiform encephalopathies in North America

Xavier Bosch

“My name is Terry S Singeltary Sr, and I live in Bacliff, Texas. I lost my mom to hvCJD (Heidenhain variant CJD) and have been searching for answers ever since. What I have found is that we have not been told the truth. CWD in deer and elk is a small portion of a much bigger problem.”

...snip

adding that, “the cases that we know about are reassuring, because they do not suggest the appearance of a new variant of CJD in the USA or atypical features in patients that might be exposed to CWD. However, until we establish a system that identifies and analyses a high proportion of suspected prion disease cases we will not know for sure”. The USA should develop a system modelled on that established in the UK, he points out....

snip...END

http://download.thelancet.com/pdfs/journals/1473-3099/PIIS1473309903007151.pdf


Diagnosis and Reporting of Creutzfeldt-Jakob Disease Singeltary, Sr et al. JAMA.2001; 285: 733-734. Vol. 285 No. 6, February 14, 2001 JAMA

Diagnosis and Reporting of Creutzfeldt-Jakob Disease

To the Editor: In their Research Letter, Dr Gibbons and colleagues1 reported that the annual US death rate due to Creutzfeldt-Jakob disease (CJD) has been stable since 1985. These estimates, however, are based only on reported cases, and do not include misdiagnosed or preclinical cases. It seems to me that misdiagnosis alone would drastically change these figures. An unknown number of persons with a diagnosis of Alzheimer disease in fact may have CJD, although only a small number of these patients receive the postmortem examination necessary to make this diagnosis. Furthermore, only a few states have made CJD reportable. Human and animal transmissible spongiform encephalopathies should be reportable nationwide and internationally.

Terry S. Singeltary, Sr Bacliff, Tex

1. Gibbons RV, Holman RC, Belay ED, Schonberger LB. Creutzfeldt-Jakob disease in the United States: 1979-1998. JAMA. 2000;284:2322-2323. FREE FULL TEXT

http://jama.ama-assn.org/cgi/content/extract/285/6/733?maxtoshow=&HITS=10&hits=10&RESULTFORMAT=&fulltext=singeltary&searchid=1&FIRSTINDEX=0&resourcetype=HWCIT


http://jama.ama-assn.org/cgi/content/full/285/6/733?maxtoshow=&HITS=10&hits=10&RESULTFORMAT=&fulltext=singeltary&searchid=1&FIRSTINDEX=0&resourcetype=HWCIT


2 January 2000 British Medical Journal U.S. Scientist should be concerned with a CJD epidemic in the U.S., as well

http://www.bmj.com/cgi/eletters/320/7226/8/b#6117


15 November 1999 British Medical Journal vCJD in the USA * BSE in U.S.

http://www.bmj.com/cgi/eletters/319/7220/1312/b#5406


Tuesday, April 29, 2008

Interference at the EPA - Science and Politics at the U.S. Environmental Protection Agency

please see full text ;

http://sciencebushwhacked.blogspot.com/


BSE INQUIRY DFAs

http://bseinquiry.blogspot.com/

Sunday, May 18, 2008 BSE Inquiry DRAFT FACTUAL ACCOUNT DFA BSE Inquiry DRAFT FACTUAL ACCOUNTS DFA's

http://bseinquiry.blogspot.com/2008/05/bse-inquiry-draft-factual-account-dfa.html

Sunday, May 18, 2008 BSE, CJD, and Baby foods (the great debate 1999 to 2005)

http://bseinquiry.blogspot.com/2008/05/bse-cjd-and-baby-foods-great-debate.html

Sunday, May 18, 2008 MAD COW DISEASE BSE CJD CHILDREN VACCINES

http://bseinquiry.blogspot.com/2008/05/mad-cow-disease-bse-cjd-children.html


SEAC Draft minutes of the 100th meeting held on 25th April 2008

http://seac992007.blogspot.com/2008/07/seac-draft-minutes-of-100th-meeting.html


Docket APHIS-2006-0041 Docket Title Bovine Spongiform Encephalopathy; Minimal-Risk Regions; Importation of Live Bovines and Products Derived from Bovines Commodities Docket Type Rulemaking Document APHIS-2006-0041-0001 Document Title Bovine Spongiform Encephalopathy; Minimal-Risk Regions; Importation of Live Bovines and Products Derived From Bovines Public Submission APHIS-2006-0041-0006 Public Submission Title Comment from Terry S Singletary Sr Views Add Comments How To Commentsnip...MY personal belief, since you ask, is that not only the Canadian border, but the USA border, and the Mexican border should be sealed up tighter than a drum for exporting there TSE tainted products, until a validated, 100% sensitive test is available, and all animals for human and animal consumption are tested. all we are doing is the exact same thing the UK did with there mad cow poisoning when they exported it all over the globe, all the while knowing what they were doing. this BSE MRR policy is nothing more than a legal tool to do just exactly what the UK did, thanks to the OIE and GW, it's legal now. and they executed Saddam for poisoning ??? go figure....

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

http://www.regulations.gov/fdmspublic/component/main?main=DocumentDetail&d=APHIS-2006-0041-0006

ONE FINAL COMMENT PLEASE, (i know this is long Dr. Freas but please bear with me)THE USA is in a most unique situation, one of unknown circumstances with human and animal TSE. THE USA has the most documented TSE in different species to date, with substrains growing in those species (BSE/BASE in cattle and CWD in deer and elk, there is evidence here with different strains), and we know that sheep scrapie has over 20 strains of the typical scrapie with atypical scrapie documented and also BSE is very likely to have passed to sheep. all of which have been rendered and fed back to animals for human and animal consumption, a frightening scenario. WE do not know the outcome, and to play with human life around the globe with the very likely TSE tainted blood from the USA, in my opinion is like playing Russian roulette, of long duration, with potential long and enduring consequences, of which once done, cannot be undone.These are the facts as i have come to know through daily and extensive research of TSE over 9 years, since 12/14/97. I do not pretend to have all the answers, but i do know to continue to believe in the ukbsenvcjd only theory of transmission to humans of only this one strain from only this one TSE from only this one part of the globe, will only lead to further failures, and needless exposure to humans from all strains of TSE, and possibly many more needless deaths from TSE via a multitude of proven routes and sources via many studies with primates and rodents and other species. ...

Terry S. Singeltary Sr. P.O. Box 42 Bacliff, Texas USA 77518snip... 48 pages...

http://www.regulations.gov/fdmspublic/ContentViewer?objectId=09000064801f3413&disposition=attachment&contentType=msw8



The statistical incidence of CJD cases in the United States has been revised to reflect that there is one case per 9000 in adults age 55 and older. Eighty-five percent of the cases are sporadic, meaning there is no known cause at present.

http://www.cjdfoundation.org/fact.html

Saturday, March 22, 2008
10 Million Baby Boomers to have Alzheimer's in the coming decades 2008 Alzheimer's disease facts and figures

http://betaamyloidcjd.blogspot.com/2008/03/association-between-deposition-of-beta.html

re-Association between Deposition of Beta-Amyloid and Pathological Prion Protein in Sporadic Creutzfeldt-Jakob Disease

http://betaamyloidcjd.blogspot.com/2008/04/re-association-between-deposition-of.html


HUMAN and ANIMAL TSE Classifications i.e. mad cow disease and the UKBSEnvCJD only theory JUNE 2008

http://cjdmadcowbaseoct2007.blogspot.com/2008/06/human-and-animal-tse-classifications-ie.html


Terry S. Singeltary Sr.

P.O. Box 42

Bacliff, Texas USA 77518

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