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From: TSS ()
Subject: Docket: 2003N-0312 - Animal Feed Safety System; ... Request for Comments
Date: August 3, 2006 at 1:06 pm PST


Docket: 2003N-0312 - Animal Feed Safety System: A Comprehensive Risk-Based Safety Program for the Manufacture and Distribution of Animal Feeds; Request for Comments

Temporary Comment Number: 88329

FDA Animal Feed Safety System (AFSS) Public Meeting
Center for Veterinary Medicine
Meeting Room A, 3rd Floor
7519 Standish Place, Rockville, MD 20855
Tuesday, September 12, 2006
9 a.m. to 4:30 p.m.

The Food and Drug Administration (FDA) is holding a public meeting to present work-in-progress on a method for ranking animal feed contaminants by their relative risks to animal and human health. At this meeting, the Agency will describe the methods it plans to use to develop animal and human Health Consequence Scoring for chemical, physical and biological feed contaminants.

The meeting will be held Tuesday, September 12, 2006, in Meeting Room A third floor, at 7519 Standish Place, Rockville, MD 20855. For additional information, please contact Zoe Gill, Center for Veterinary Medicine (HFV-226), Food and Drug Administration, 7519 Standish Place, Rockville, MD 20855, 240-453-6867, Fax 240-453-6882 or email: zoe.gill@fda.hhs.gov.

Prior to the public meeting, the FDA will place two documents in Docket No. 2003N-0312 entitled, “List of Potentially Hazardous Contaminants in Animal Feed and Feed Ingredients” and “Determining Health Consequence Scoring for Feed Contaminants.” The documents will summarize the Agency’s methods for assigning animal and human Health Consequence Scoring to physical, chemical and biological contaminants that may be present in animal feed. Details of these methods will be discussed at the meeting. An agenda for the meeting will also be placed in docket.

You may submit written comments to the Division of Dockets Management (HFA 305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Two copies of written comments are to be submitted, except that individuals may submit one copy. Information on how to submit written or electronic comments can be found at http://www.accessdata.fda.gov/scripts/oc/dockets/comments/FAQ.cfm?AGENCY=FDA#_Toc62455540.

Due to limited meeting space, registration will be required. We strongly encourage early registration. Registration is by telephone, fax or e-mail. Please use the registration form to provide registration information (including name, title, firm name, address, telephone, and fax number) to Nanette Milton, Center for Veterinary Medicine (HFV-200), Food and Drug Administration, 7519 Standish Place, Rockville, MD 20855, 240-453-6840, Fax 240-453-6880 or email: nanette.milton@fda.hhs.gov.

Federal Register Notice

Registration Form

Draft Agenda August 1, 2006

Meeting Materials

List of Potentially Hazardous Contaminants in Animal Feed and Feed Ingredients

Determining Health Consequence Scoring for Feed Contaminants

http://www.fda.gov/cvm/AFSS092006PM.htm

DRAFT LIST OF POTENTIALLY HAZARDOUS CONTAMINANTS IN ANIMAL FEED AND FEED INGREDIENTS


1. BIOLOGICAL CONTAMINANTS


A. Transmissible Spongiform Encephalopathies

i. Bovine spongiform encephalopathy (BSE)

ii. Chronic wasting disease (CWD)

B. Microbiological Contaminants

snip...end


http://www.fda.gov/cvm/Documents/FeedContaminants.pdf

Greetings,


I would kindly like to submit the following to ;


Docket No. 2003N-0312 entitled, “List of Potentially Hazardous Contaminants in Animal Feed and Feed Ingredients”
and “Determining Health Consequence Scoring for Feed Contaminants.”


I am very disturbed that other TSE in the USA are not on this list. The USA has the most
documented TSE in the world, all of which have been fed to humans and animals for human consumption.
CJD has been on the rise in the USA, in fact has tripled over the past years, with 'unknown' strains showing
being documented.


WHAT about Scrapie in sheep and goats, and what about atypical scrapie?

WHAT about the atypical TSE in the bovine in Texas and Alabama I.E. BASE ?

WHAT about TME?

DOES this mean all of the above are not any concern in animal feed?

WHAT about blood?


What about all those broken promises on Expanded "Mad Cow" Safeguards Announced
to Strengthen Existing Firewalls Against BSE Transmission that were promised to consumers
on Monday, Jan. 26, 2004 ;


Press Release

FOR IMMEDIATE RELEASE
Monday, Jan. 26, 2004
FDA Press Office
301-827-6242


Expanded "Mad Cow" Safeguards Announced
to Strengthen Existing Firewalls Against BSE Transmission
HHS Secretary Tommy G. Thompson today announced several new public health measures, to be implemented by the Food and Drug Administration (FDA), to strengthen significantly the multiple existing firewalls that protect Americans from exposure to the agent thought to cause bovine spongiform encephalopathy (BSE, also known as mad cow disease) and that help prevent the spread of BSE in U.S. cattle.

The existing multiple firewalls, developed by both the U.S. Department of Agriculture (USDA) and HHS, have been extremely effective in protecting the American consumer from exposure to BSE. The first firewall is based on import controls started in 1989. A second firewall is surveillance of the U.S. cattle population for the presence of BSE, a USDA firewall that led to the finding of the BSE cow in December. The third firewall is FDA's 1997 animal feed ban, which is the critical safeguard to help prevent the spread of BSE through cattle herds by prohibiting the feeding of most mammalian protein to ruminant animals, including cattle. The fourth firewall, recently announced by USDA, makes sure that no bovine tissues known to be at high risk for carrying the agent of BSE enter the human food supply regulated by USDA. The fifth firewall is effective response planning to contain the potential for any damage from a BSE positive animal, if one is discovered. This contingency response plan, which had been developed over the past several years, was initiated immediately upon the discovery of a BSE positive cow in Washington State December 23.

The new safeguards being announced today are science-based and further bolster these already effective safeguards.

Specifically, HHS intends to ban from human food (including dietary supplements), and cosmetics a wide range of bovine-derived material so that the same safeguards that protect Americans from exposure to the agent of BSE through meat products regulated by USDA also apply to food products that FDA regulates.

FDA will also prohibit certain currently allowed feeding and manufacturing practices involving feed for cattle and other ruminant animals. These additional measures will further strengthen FDA's 1997 "animal feed" rule.

"Today's actions will make strong public health protections against BSE even stronger," Secretary Thompson said. "Although the current animal feed rule provides a strong barrier against the further spread of BSE, we must never be satisfied with the status quo where the health and safety of our animals and our population is at stake. The science and our own experience and knowledge in this area are constantly evolving. Small as the risk may already be, this is the time to make sure the public is protected to the greatest extent possible."

"Today we are bolstering our BSE firewalls to protect the public," said FDA Commissioner Mark B. McClellan, M.D., Ph.D. "We are further strengthening our animal feed rule, and we are taking additional steps to further protect the public from being exposed to any potentially risky materials from cattle. FDA's vigorous inspection and enforcement program has helped us achieve a compliance rate of more than 99 percent with the feed ban rule, and we intend to increase our enforcement efforts to assure compliance with our enhanced regulations. Finally, we are continuing to assist in the development of new technologies that will help us in the future improve even further these BSE protections. With today's actions, FDA will be doing more than ever before to protect the public against BSE by eliminating additional potential sources of BSE exposure."

To implement these new protections, FDA will publish two interim final rules that will take effect immediately upon publication, although there will be an opportunity for public comment after publication.

The first interim final rule will ban the following materials from FDA-regulated human food, (including dietary supplements) and cosmetics:

Any material from "downer" cattle. ("Downer" cattle are animals that cannot walk.)
Any material from "dead" cattle. ("Dead" cattle are cattle that die on the farm (i.e. before reaching the slaughter plant);
Specified Risk Materials (SRMs) that are known to harbor the highest concentrations of the infectious agent for BSE, such as the brain, skull, eyes, and spinal cord of cattle 30 months or older, and a portion of the small intestine and tonsils from all cattle, regardless of their age or health; and
The product known as mechanically separated beef, a product which may contain SRMs. Meat obtained by Advanced Meat Recovery (an automated system for cutting meat from bones), may be used since USDA regulations do not allow the presence of SRMs in this product.
The second interim final rule is designed to lower even further the risk that cattle will be purposefully or inadvertently fed prohibited protein. It was the feeding of such protein to cattle that was the route of disease transmission that led to the BSE epidemic in United Kingdom cattle in the 1980's and 1990's.

This interim final rule will implement four specific changes in FDA's present animal feed rule. First, the rule will eliminate the present exemption in the feed rule that allows mammalian blood and blood products to be fed to other ruminants as a protein source. Recent scientific evidence suggests that blood can carry some infectivity for BSE.

Second, the rule will also ban the use of "poultry litter" as a feed ingredient for ruminant animals. Poultry litter consists of bedding, spilled feed, feathers, and fecal matter that are collected from living quarters where poultry is raised. This material is then used in cattle feed in some areas of the country where cattle and large poultry raising operations are located near each other. Poultry feed may legally contain protein that is prohibited in ruminant feed, such as bovine meat and bone meal. The concern is that spillage of poultry feed in the chicken house occurs and that poultry feed (which may contain protein prohibited in ruminant feed) is then collected as part of the "poultry litter" and added to ruminant feed.

Third, the rule will ban the use of "plate waste" as a feed ingredient for ruminants. Plate waste consists of uneaten meat and other meat scraps that are currently collected from some large restaurant operations and rendered into meat and bone meal for animal feed. The use of "plate waste" confounds FDA's ability to analyze ruminant feeds for the presence of prohibited proteins, compromising the Agency's ability to fully enforce the animal feed rule.

Fourth, the rule will further minimize the possibility of cross-contamination of ruminant and non-ruminant animal feed by requiring equipment, facilities or production lines to be dedicated to non-ruminant animal feeds if they use protein that is prohibited in ruminant feed. Currently, some equipment, facilities and production lines process or handle prohibited and non-prohibited materials and make both ruminant and non-ruminant feed -- a practice which could lead to cross-contamination.

To accompany these new measures designed to provide a further layer of protection against BSE, FDA will in 2004 step up its inspections of feed mills and renderers. FDA will itself conduct 2,800 inspections and will make its resources go even further by continuing to work with state agencies to fund 3,100 contract inspections of feed mill and renderers and other firms that handle animal feed and feed ingredients. Through partnerships with states, FDA will also receive data on 700 additional inspections, for a total of 3,800 state contract and partnership inspections in 2004 alone, including annual inspections of 100 percent of all known renderers and feed mills that process products containing materials prohibited in ruminant feed.

"We have worked hard with the rendering and animal feed production industries to try and achieve full compliance with the animal feed rule," said Dr. McClellan, "and through strong education and a vigorous enforcement campaign, backed by additional inspections and resources, we intend to maintain a high level of compliance."

Dr. McClellan also noted that, in response to finding a BSE positive cow in Washington state December 23, FDA inspected and traced products at 22 facilities related to that positive cow or products from the cow, including feed mills, farms, dairy farms, calf feeder lots, slaughter houses, meat processors, transfer stations, and shipping terminals. Moreover, FDA has conducted inspections at the rendering facilities that handled materials from the positive cow, and they were found to be fully in compliance with FDA's feed rule.

To further strengthen protections for Americans, FDA/HHS intends to work with Congress to consider proposals to assure that these important protective measures will be implemented as effectively as possible.

FDA is also continuing its efforts to assist in the development of better BSE science, to achieve the same or greater confidence in BSE protection at a lower cost. For example, to enhance the ability of our public health system to detect prohibited materials in animal feed, FDA will continue to support the development and evaluation of diagnostic tests to identify prohibited materials. These tests would offer a quick and reliable method of testing animal feeds for prohibited materials and for testing other products for contamination with the agent thought to cause BSE.

FDA has publicly discussed many of the measures being announced today with stakeholders in workshops, videoconferences, and public meetings. In addition, FDA published an Advance Notice of Proposed Rulemaking in November 2002 (available online at http://www.fda.gov/OHRMS/DOCKETS/98fr/110602c.htm concerning possible changes to the animal feed rule.

Comprehensive information about FDA's work on BSE and links to other related websites are available at http://www.fda.gov.

###

http://www.fda.gov/bbs/topics/news/2004/hhs_012604.html

Approach:
This project will be done as a Specific Cooperative Agreement with the Italian BSE Reference Laboratory, Istituto Zooprofilattico Sperimentale del Piemonte, in Turin, Italy. It is essential for the U.S. BSE surveillance program to analyze the effectiveness of the U.S diagnostic tools for detection of atypical cases of BSE. Molecular comparisons of the U.S. BSE isolate with atypical BSE isolates will provide further characterization of the U.S. BSE isolate. Transmission studies are already underway using brain homogenates from atypical BSE cases into mice, cattle and sheep. It will be critical to see whether the atypical BSE isolates behave similarly to typical BSE isolates in terms of transmissibility and disease pathogenesis. If transmission occurs, tissue distribution comparisons will be made between cattle infected with the atypical BSE isolate and the U.S. BSE isolate. Differences in tissue distribution could require new regulations regarding specific risk material (SRM) removal.

http://www.ars.usda.gov/research/projects/projects.htm?ACCN_NO=408490


BASE in cattle in Italy of Identification of a second bovine amyloidotic
spongiform encephalopathy: Molecular similarities with

sporadic Creutzfeldt-Jakob disease


http://www.pnas.org/cgi/content/abstract/0305777101v1

REPORT OF THE COMMITTEE ON SCRAPIE

Chair: Dr. Jim Logan, Cheyenne, WY

Vice Chair: Dr. Joe D. Ross, Sonora, TX

Dr. Deborah L. Brennan, MS; Dr. Beth Carlson, ND; Dr. John R. Clifford, DC; Dr. Thomas F. Conner, OH; Dr. Walter E. Cook, WY; Dr. Wayne E. Cunningham, CO; Dr. Jerry W. Diemer, TX; Dr. Anita J. Edmondson, CA; Dr. Dee Ellis, TX; Dr. Lisa A. Ferguson, MD; Dr. Keith R. Forbes, NY; Dr. R. David Glauer, OH; Dr. James R. Grady, CO; Dr. William L. Hartmann, MN; Dr. Carolyn Inch, CAN; Dr. Susan J. Keller, ND; Dr. Allen M. Knowles, TN; Dr. Thomas F. Linfield, MT; Dr. Michael R. Marshall, UT; Dr. Cheryl A. Miller, In; Dr. Brian V. Noland, CO; Dr. Charles Palmer, CA; Dr. Kristine R. Petrini, MN; Mr. Stan Potratz, IA; Mr. Paul E. Rodgers, CO; Dr. Joan D. Rowe, CA; Dr. Pamela L. Smith, IA; Dr. Diane L. Sutton, MD; Dr. Lynn Anne Tesar, SD; Dr. Delwin D. Wilmot, NE; Dr. Nora E. Wineland, CO; Dr. Cindy B. Wolf, MN.

The Committee met on November 9, 2005, from 8:00am until 11:55am, Hershey Lodge and Convention Center, Hershey, Pennsylvania. The meeting was called to order by Dr. Jim Logan, chair, with vice chairman Dr. Joe D. Ross attending. There were 74 people in attendance.

The Scrapie Program Update was provided by Dr. Diane Sutton, National Scrapie Program Coordinator, United States Department of Agriculture (USDA), Animal and Plant Health Inspection Services (APHIS), Veterinary Services (VS). The complete text of the Status Report is included in these Proceedings.

Dr. Patricia Meinhardt, USDA-APHIS-VS-National Veterinary Services Laboratory (NVSL) gave the Update on Genotyping Labs and Discrepancies in Results. NVSL conducts investigations into discrepancies on genotype testing results associated with the Scrapie Eradication Program. It is the policy of the Program to conduct a second genotype test at a second laboratory on certain individual animals. Occasionally, there are discrepancies in those results. The NVSL conducts follow-up on these situations through additional testing on additional samples from the field and archive samples from the testing laboratories.

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.

To reduce/eliminate these problems, the Program has placed additional quality requirements on the testing laboratories: additional review of final reports, additional coding systems for testing operations, strict follow-up and reports to NVSL on corrective actions, dual data entry systems, and more frequent inspections.

The Agricultural Research Services (ARS) Scrapie Research Update was given by Janet Alverson, USDA- ARS. Dr. Alverson reported on the effect of multiple births and fetal position within the uterus on PrP-Sc accumulation in fetal cotyledons. Fetal cotyledons of fetuses with

resistant genotypes can accumulate PrP-Sc when positioned next to a fetus of susceptible genotype with cotyledons positive for PrP-Sc accumulation.

Scrapie Surveillance Evaluation Working Group Update was presented by Tracey Lynn, Epidemiologist with the National Surveillance Unit, Center for Epidemiology and Animal Health (CEAH). The presentation provided a background on evaluation, a quick review of analyses completed to date by the scrapie surveillance evaluation working group, and some of the preliminary findings. The process of surveillance system evaluation is undertaken to assist a disease control program with identifying possible improvements to their surveillance system, and includes an assessment of the overall utility of the system, identification of potential gaps in coverage, and an evaluation of the overall performance of the system. The scrapie surveillance evaluation working group reviewed the structure and processes of the scrapie surveillance program, as well as various quality and effectiveness measures.

Overall, 98-99% of surveillance samples come from the Regulatory Scrapie Surveillance System (RSSS), so the RSSS system has been the primary focus of the evaluation process. The working group developed a flow chart indicating the flow of sheep through RSSS, which identified potential gaps in surveillance coverage, including custom kill plants and sheep being exported to Mexico. Spatial analyses can assist in identifying areas with high density sheep populations with lower levels of RSSS sampling. Identification compliance is being evaluated by reviewing reports from slaughter plants on the proportion of animals with appropriate identification. Additional analyses remain, including defining the most appropriate economic analyses, and comparing the surveillance system with developing surveillance standards. The working group hopes to have a draft written report for review by the end of the year.

Giving the Update on Scrapie Diagnostics and Susceptibility was Katherine O’Roarke, Research Microbiologist, USDA-ARS. "What’s New in Scrapie" -- Biopsy sampling of the third eyelid or tonsillar lymphoid tissue is a useful live animal test for scrapie. The biopsy sample is examined for accumulation of the abnormal prion protein using immunohistochemistry. A joint project conducted by the Veterinary Laboratory Agencies and the Moredun Institute in the United Kingdom has developed an alternative technique in which tissue is collected from the narrow band of lymphoid tissue near the rectal-anal junction. The morphology of the lymphoid follicles is similar in the tonsil, retropharyngeal lymph nodes, third eyelid, and rectal-anal mucosal tissue. A report on more than 300 sheep in the United Kingdom (UK), prepared by Drs. Lorenzo Gonzalez and Jeffrey Martin, will describe the sensitivity, specificity, and optimal collection interval for this technique in a variety of breeds of British sheep. ARS has done a preliminary evaluation of the technique in US sheep. Samples of third eyelid and rectal-mucosal tissue were collected from 56 sheep. Forty-two (42) sheep had negative biopsies at both sites; most of these sheep have been necropsied and no PrP-d was found in retropharyngeal lymph node or tonsil, showing good agreement with the antemortem biopsies. Fourteen (14) sheep had positive rectal biopsy samples; of those, only 12 had positive eyelid biopsies. These sheep will be monitored for disease development. However, the protocol is identical for all samples and it is probable that these sheep represent false negative third eyelid results. Abstracts of reports on the UK studies indicate that sensitivity of the test was 70% in the UK; similar large scale testing on US sheep is necessary. The biopsy tissue is somewhat difficult to handle in the tissue processing laboratory and adaptation to an ELISA format may improve test performance.

Alexia McKnight, Assistant Professor of Radiology, University of Pennsylvania, reviewed magnetic resonance imaging (MRI) diagnostics before the committee. A synopsis containing references is attached at the end of this report. Dr. McKnight asked the question, "could MRI be a cost-effective screening test, estimated at $25-30 each with results immediately available." The committee feels that it is not practical as compared to other alternatives currently available. However, the committee expressed interest in future reference to this technology.

Dr. Diane Sutton lead the Uniform Methods and Rules (UM&R) and Regulatory Issues Discussion. Several modifications to the UM&R were discussed. Eight issues were identified and communicated to the APHIS scrapie program coordinator. The committee acknowledged that APHIS and the industry is adequately addressing the year-to-year industry concerns.

Dr. Kris Petrini representing the North Central United States Animal Health Association District presented five recommendations to the Committee. During the discussions regarding these recommendations it was evident that all five issues had been addressed during the year at this Committee meeting.

The Committee approved a recommendation that USDA-APHIS-VS continue to provide indemnity funds for animals that have been designated for testing in Flocks Under Investigation as an alternative to third eyelid testing after consultation with the designated Scrapie Epidemiologist (DSE) and the Regional Area Epidemiologist (RAE).

The 2004 Resolutions along with their responses were reviewed by the Committee.

A Resolution concerning premises registration and identification was approved by the Committee and forwarded to the Committee on Nominations and Resolutions.

Committee on Scrapie

Status Report-Fiscal Year 2005: Cooperative State-Federal Scrapie Eradication Program

Submitted by Diane Sutton, DVM and Gary Ross, DVM

National Center for Animal Health Programs, APHIS, USDA

In Fiscal Year 2005 the Scrapie Eradication Program focused on: (1) utilization of a genetic based approach to flock clean-up plans; (2) cleaning up infected and source flocks; (3) tracing and testing exposed animals and flocks; (4) expansion of regulatory slaughter surveillance (RSSS); (5) conducting considtent state reviews, (6) producer education; (7) upgrading of the Scrapie National Generic Database and (8) publishing the updated Scrapie Eradication Uniform Methods and Rules (UM&R). The current Scrapie Eradication UM&R is posted at http://www.aphis.usda.gov/vs/nahps/scrapie/umr-scrapie-erad.pdf.

Consistent State Reviews

States must meet the requirements in 9 CFR 79.6 in order to move sheep and goats in interstate commerce with minimal restrictions. Twenty seven states have enacted the required identification rules, the remaining states have submitted a work plan that describes the steps that will be taken to comply and provided a timeline for completing significant milestones. USDA is conducting onsite scrapie program consistent state reviews and has completed reviews in 12 states. States must be in full compliance by the end of their current rule making cycle. States not in full compliance at that time will be removed from the consistent state list. Removal from the list would create a significant impact on the interstate movement of sheep and goats from those States.

Scrapie Flock Certification Program

As of September 30, 2005, there were 1,961 flocks participating in the Scrapie Flock Certification Program (SFCP). Of these flocks 188 were certified flocks, 1,770 were complete monitored flocks, and 3 were selective monitored flocks (figure 2). There were 209 flocks newly enrolled and 53 newly certified (13 with status dates in FY 2005 and 40 with status dates in previous years) in FY 2005 (figure 3).

Infected and Source Flocks

As of September 30, 2005, there were 105 scrapie infected and source flocks. There were a total of 165** new infected and source flocks reported for FY 2005. The total infected and source flocks that have been released in FY 2005 was 128. The ratio of infected and source flocks cleaned up or placed on clean up plans vs. new infected and source flocks discovered in FY 2005 was 1.03 : 1*. In addition 622 scrapie cases were confirmed and reported by the National Veterinary Services Laboratories (NVSL) in FY 2005, of which 130 were RSSS cases. Fifteen cases of scrapie in goats have been reported since 1990. The last goat case was reported in May 2005. Approximately 5,626 animals were indemnified comprised of 49% non-registered sheep, 45% registered sheep, 1.4% non-registered goats and 4.6% registered goats.

Regulatory Scrapie Slaughter Surveillance (RSSS)

RSSS was designed to utilize the findings of the Center for Epidemiology and Animal Health (CEAH) Scrapie: Ovine Slaughter Surveillance (SOSS) study. The results of SOSS can be found at http://www.aphis.usda.gov/vs/ceah/cahm/Sheep/sheep.htm . RSSS started April 1,

2003. It is a targeted slaughter surveillance program which is designed to identify infected flocks for clean-up. During FY 2005 collections increased by 32% overall and by 90% for black and mottled faced sheep improving overall program effectiveness and efficiency as demonstrated by the 26% decrease in percent positive black faced sheep compared to FY 2004. Samples have been collected from 62,864 sheep since April 1, 2003, of which results have been reported for 59,105 of which 209 were confirmed positive. During FY 2005, 33,137 samples were collected from 81 plants. There have been 130 NVSL confirmed positive cases (30 collected in FY 2004 and confirmed in FY 2005 and 100 collected and confirmed in FY 2005) in FY 2005. Face colors of these positives were 114 black, 14 mottled, 1 white and 1 unknown. The percent positive by face color is shown in the chart below.

Scrapie Testing

In FY 2005, 35,845 animals have been tested for scrapie: 30,192 RSSS; 4,742 regulatory field cases; 772 regulatory third eyelid biopsies; 10 third eyelid validations; and 129 necropsy validations (chart 9).

Animal ID

As of October 04, 2005, 103,580 sheep and goat premises have been assigned identification numbers in the Scrapie National Generic Database. Official eartags have been issued to 73,807 of these premises.

*This number based on an adjusted 12 month interval to accommodate the 60 day period for setting up flock plans.


http://www.usaha.org/committees/reports/2005/report-scr-2005.pdf

Published online before print October 20, 2005

Proc. Natl. Acad. Sci. USA, 10.1073/pnas.0502296102
Medical Sciences

A newly identified type of scrapie agent can naturally infect sheep with resistant PrP genotypes

( sheep prion | transgenic mice )

Annick Le Dur *, Vincent Béringue *, Olivier Andréoletti , Fabienne Reine *, Thanh Lan Laï *, Thierry Baron , Bjørn Bratberg ¶, Jean-Luc Vilotte ||, Pierre Sarradin **, Sylvie L. Benestad ¶, and Hubert Laude *
*Virologie Immunologie Moléculaires and ||Génétique Biochimique et Cytogénétique, Institut National de la Recherche Agronomique, 78350 Jouy-en-Josas, France; Unité Mixte de Recherche, Institut National de la Recherche Agronomique-Ecole Nationale Vétérinaire de Toulouse, Interactions Hôte Agent Pathogène, 31066 Toulouse, France; Agence Française de Sécurité Sanitaire des Aliments, Unité Agents Transmissibles Non Conventionnels, 69364 Lyon, France; **Pathologie Infectieuse et Immunologie, Institut National de la Recherche Agronomique, 37380 Nouzilly, France; and ¶Department of Pathology, National Veterinary Institute, 0033 Oslo, Norway


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

Scrapie in small ruminants belongs to transmissible spongiform encephalopathies (TSEs), or prion diseases, a family of fatal neurodegenerative disorders that affect humans and animals and can transmit within and between species by ingestion or inoculation. Conversion of the host-encoded prion protein (PrP), normal cellular PrP (PrPc), into a misfolded form, abnormal PrP (PrPSc), plays a key role in TSE transmission and pathogenesis. The intensified surveillance of scrapie in the European Union, together with the improvement of PrPSc detection techniques, has led to the discovery of a growing number of so-called atypical scrapie cases. These include clinical Nor98 cases first identified in Norwegian sheep on the basis of unusual pathological and PrPSc molecular features and "cases" that produced discordant responses in the rapid tests currently applied to the large-scale random screening of slaughtered or fallen animals. Worryingly, a substantial proportion of such cases involved sheep with PrP genotypes known until now to confer natural resistance to conventional scrapie. 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.


--------------------------------------------------------------------------------

Author contributions: H.L. designed research; A.L.D., V.B., O.A., F.R., T.L.L., J.-L.V., and H.L. performed research; T.B., B.B., P.S., and S.L.B. contributed new reagents/analytic tools; V.B., O.A., and H.L. analyzed data; and H.L. wrote the paper.

A.L.D. and V.B. contributed equally to this work.

To whom correspondence should be addressed.

Hubert Laude, E-mail: laude@jouy.inra.fr

www.pnas.org/cgi/doi/10.1073/pnas.0502296102


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


12/10/76
AGRICULTURAL RESEARCH COUNCIL
REPORT OF THE ADVISORY COMMITTE ON SCRAPIE
Office Note
CHAIRMAN: PROFESSOR PETER WILDY

snip...

A The Present Position with respect to Scrapie
A] The Problem

Scrapie is a natural disease of sheep and goats. It is a slow
and inexorably progressive degenerative disorder of the nervous system
and it ia fatal. It is enzootic in the United Kingdom but not in all
countries.

The field problem has been reviewed by a MAFF working group
(ARC 35/77). It is difficult to assess the incidence in Britain for
a variety of reasons but the disease causes serious financial loss;
it is estimated that it cost Swaledale breeders alone $l.7 M during
the five years 1971-1975. A further inestimable loss arises from the
closure of certain export markets, in particular those of the United
States, to British sheep.

It is clear that scrapie in sheep is important commercially and
for that reason alone effective measures to control it should be
devised as quickly as possible.

Recently the question has again been brought up as to whether
scrapie is transmissible to man. This has followed reports that the
disease has been transmitted to primates. One particularly lurid
speculation (Gajdusek 1977) conjectures that the agents of scrapie,
kuru, Creutzfeldt-Jakob disease and transmissible encephalopathy of
mink are varieties of a single "virus". The U.S. Department of
Agriculture concluded that it could "no longer justify or permit
scrapie-blood line and scrapie-exposed sheep and goats to be processed
for human or animal food at slaughter or rendering plants" (ARC 84/77)"
The problem is emphasised by the finding that some strains of scrapie
produce lesions identical to the once which characterise the human
dementias"

Whether true or not. the hypothesis that these agents might be
transmissible to man raises two considerations. First, the safety
of laboratory personnel requires prompt attention. Second, action
such as the "scorched meat" policy of USDA makes the solution of the
acrapie problem urgent if the sheep industry is not to suffer
grievously.

snip...

76/10.12/4.6

http://www.bseinquiry.gov.uk/files/yb/1976/10/12004001.pdf

Neurobiology
Adaptation of the bovine spongiform encephalopathy agent to primates and
comparison with Creutzfeldt- Jakob disease: Implications for human health
Corinne Ida Lasmézas*,, Jean-Guy Fournier*, Virginie Nouvel*, Hermann Boe*,
Domíníque Marcé*, François Lamoury*, Nicolas Kopp, Jean-Jacques Hauw§, James
Ironside¶, Moira Bruce, Dominique Dormont*, and Jean-Philippe Deslys*
* Commissariat à l'Energie Atomique, Service de Neurovirologie, Direction
des Sciences du Vivant/Département de Recherche Medicale, Centre de
Recherches du Service de Santé des Armées 60-68, Avenue du Général Leclerc,
BP 6, 92 265 Fontenay-aux-Roses Cedex, France; Hôpital Neurologique Pierre
Wertheimer, 59, Boulevard Pinel, 69003 Lyon, France; § Laboratoire de
Neuropathologie, Hôpital de la Salpêtrière, 83, Boulevard de l'Hôpital,
75013 Paris, France; ¶ Creutzfeldt-Jakob Disease Surveillance Unit, Western
General Hospital, Crewe Road, Edinburgh EH4 2XU, United Kingdom; and
Institute for Animal Health, Neuropathogenesis Unit, West Mains Road,
Edinburgh EH9 3JF, United Kingdom

Edited by D. Carleton Gajdusek, Centre National de la Recherche
Scientifique, Gif-sur-Yvette, France, and approved December 7, 2000
(received for review October 16, 2000)


Abstract

There is substantial scientific evidence to support the notion that bovine
spongiform encephalopathy (BSE) has contaminated human beings, causing
variant Creutzfeldt-Jakob disease (vCJD). This disease has raised concerns
about the possibility of an iatrogenic secondary transmission to humans,
because the biological properties of the primate-adapted BSE agent are
unknown. We show that (i) BSE can be transmitted from primate to primate by
intravenous route in 25 months, and (ii) an iatrogenic transmission of vCJD
to humans could be readily recognized pathologically, whether it occurs by
the central or peripheral route. Strain typing in mice demonstrates that the
BSE agent adapts to macaques in the same way as it does to humans and
confirms that the BSE agent is responsible for vCJD not only in the United
Kingdom but also in France. The agent responsible for French iatrogenic
growth hormone-linked CJD taken as a control is very different from vCJD but
is similar to that found in one case of sporadic CJD and one sheep scrapie
isolate. These data will be key in identifying the origin of human cases of
prion disease, including accidental vCJD transmission, and could provide
bases for vCJD risk assessment.


http://www.pnas.org/cgi/content/full/041490898v1


The EMBO Journal, Vol. 19, No. 17 pp. 4425-4430, 2000
© European Molecular Biology Organization

Evidence of a molecular barrier limiting
susceptibility of humans, cattle and sheep to
chronic wasting disease

G.J. Raymond1, A. Bossers2, L.D. Raymond1, K.I. O?Rourke3,
L.E. McHolland4, P.K. Bryant III4, M.W. Miller5, E.S. Williams6, M.
Smits2
and B. Caughey1,7

1NIAID/NIH Rocky Mountain Laboratories, Hamilton, MT 59840,
3USDA/ARS/ADRU, Pullman, WA 99164-7030, 4USDA/ARS/ABADRL,
Laramie, WY 82071, 5Colorado Division of Wildlife, Wildlife Research
Center, Fort Collins, CO 80526-2097, 6Department of Veterinary Sciences,
University of Wyoming, Laramie, WY 82070, USA and 2ID-Lelystad,
Institute for Animal Science and Health, Lelystad, The Netherlands
7Corresponding author e-mail: bcaughey@nih.gov Received June 7, 2000;
revised July 3, 2000; accepted July 5, 2000.

Abstract

Chronic wasting disease (CWD) is a transmissible
spongiform encephalopathy (TSE) of deer and elk,
and little is known about its transmissibility to other
species. An important factor controlling
interspecies TSE susceptibility is prion protein (PrP)
homology between the source and recipient
species/genotypes. Furthermore, the efficiency with which
the protease-resistant PrP (PrP-res) of one
species induces the in vitro conversion of the normal PrP
(PrP-sen) of another species to the
protease-resistant state correlates with the cross-species
transmissibility of TSE agents. Here we
show that the CWD-associated PrP-res (PrPCWD) of cervids
readily induces the conversion of recombinant cervid PrP-sen
molecules to the protease-resistant state in accordance
with the known transmissibility of CWD between cervids. In contrast,
PrPCWD-induced conversions of human and bovine PrP-sen were
much less efficient, and conversion of ovine PrP-sen was
intermediate. These results demonstrate a barrier at the
molecular level that should limit the susceptibility of these non-cervid
species to CWD.

snip...

Clearly, it is premature to draw firm conclusions about CWD
passing naturally into humans, cattle and sheep, but the present
results suggest that CWD transmissions to humans would be as
limited by PrP incompatibility as transmissions of BSE or sheep
scrapie to humans. Although there is no evidence that sheep
scrapie has affected humans, it is likely that BSE has caused variant
CJD in 74 people (definite and probable variant CJD cases to
date according to the UK CJD Surveillance Unit). Given the
presumably large number of people exposed to BSE infectivity,
the susceptibility of humans may still be very low compared with
cattle, which would be consistent with the relatively inefficient
conversion of human PrP-sen by PrPBSE. Nonetheless, since
humans have apparently been infected by BSE, it would seem prudent
to take reasonable measures to limit exposure of humans
(as well as sheep and cattle) to CWD infectivity as has been
recommended for other animal TSEs.

snip...

http://www.emboj.org/current.shtml


Oral transmission of kuru, Creutzfeldt-Jakob disease, and scrapie to
nonhuman primates.

Gibbs CJ Jr, Amyx HL, Bacote A, Masters CL, Gajdusek DC.

Kuru and Creutzfeldt-Jakob disease of humans and scrapie disease of
sheep and goats were transmitted to squirrel monkeys (Saimiri sciureus) that
were exposed to the infectious agents only by their nonforced consumption of
known infectious tissues. The asymptomatic incubation period in the one
monkey exposed to the virus of kuru was 36 months; that in the two monkeys
exposed to the virus of Creutzfeldt-Jakob disease was 23 and 27 months,
respectively; and that in the two monkeys exposed to the virus of scrapie
was 25 and 32 months, respectively. Careful physical examination of the
buccal cavities of all of the monkeys failed to reveal signs or oral
lesions. One additional monkey similarly exposed to kuru has remained
asymptomatic during the 39 months that it has been under observation.


PMID: 6997404


http://www.ncbi.nlm.nih.gov/entrez/query.fcgicmd=Retrieve&db=PubMed&list_uids=6997404&dopt=Abstract


Subject: SCRAPIE and CWD USA UPDATE July 19, 2006
Date: July 19, 2006 at 12:06 pm PST
SCRAPIE USA UPDATE MAY 31, 2006


Infected and Source Flocks

As of May 31, 2006, there were 93 scrapie infected and source flocks (Figure 3). There were 12 new infected and source flocks reported in May (Figure 4) with a total of 67 flocks reported for FY 2006 (Figure 5). The total infected and source flocks that have been released in FY 2006 are 53 (Figure 6), with 7 flocks released in May. The ratio of infected and source flocks released to newly infected and source flocks for FY 2006 = 0.79 : 1. In addition, as of May 31, 2006, 216 scrapie cases have been confirmed and reported by the National Veterinary Services Laboratories (NVSL), of which 33 were RSSS cases (Figure 7). This includes 33 newly confirmed cases in May 2006 (Figure 8). Eighteen cases of scrapie in goats have been reported since 1990 (Figure 9). The last goat case was reported in March 2006. New infected flocks, source flocks, and flocks released for FY 2006 are depicted in Chart 3. New infected and source statuses from 1997 to 2006 are depicted in Chart 4.

snip...

Scrapie Testing

In FY 2006, 26,185 animals have been tested for scrapie : 22,634 RSSS*; 2063 regulatory field cases; 61 necropsy validations, 5 rectal biopsy and 1427 regulatory third eyelid biopsies (Chart 9). ...

snip...END

http://www.aphis.usda.gov/vs/nahps/scrapie/monthly_report/monthly-report.html

DECLARATION OF EXTRAORDINARY EMERGENCY BECAUSE OF AN ATYPICAL T.S.E. (PRION DISEASE) OF FOREIGN ORIGIN IN THE UNITED STATES

http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?dbname=2000_register&docid=fr20jy00-31

DECLARATION OF EXTRAORDINARY EMERGENCY BECAUSE OF AN ATYPICAL T.S.E (PRION DISEASE) OF FOREIGN ORIGIN IN THE UNITED STATES [2]

http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?dbname=2000_register&docid=fr20jy00-32


Mink pelt production in the United States in 2005 totaled
2.63 million pelts, up 3 percent from 2004. Wisconsin, the largest
mink producing State, produced 778,000 pelts. Utah the second
largest producing State, produced 600,000 pelts.

The number of pelts by color class as a percent of the total U.S.
production in 2005 is as follows: Black at 47.6 percent, Mahogany
at 20.9 percent, Blue Iris at 11.3 percent, Demi/Wild at
6.3 percent, Sapphire at 4.0 percent, and White at 3.8 percent.
The remaining color classes accounted for 6.1 percent.

Value of Pelt Production Up 33 Percent

Mink pelts produced during the 2005 crop year were valued at
$160 million, up 33 percent from $120 million a year ago. The
average price per pelt for the 2005 crop year was $60.90, up from
$47.10 in 2004. .....snip.......end

http://usda.mannlib.cornell.edu/reports/nassr/other/zmi-bb/mink0706.pdf

TME

http://www.aphis.usda.gov/lpa/pubs/fsheet_faq_notice/fs_ahtme.html


Title: Experimental Inoculation of Tme, Scrapie, and Cwd to Raccoons: An Update

Authors

Hamir, Amirali
Miller, Janice - ARS RETIRED
Cutlip, Randall - ARS RETIRED
Stack, Mick - VLA-WEYBRIDGE, UK
Chaplin, Melanie - VLA-WEYBRIDGE, UK
Bartz, Jason - CREIGHTON UNIVERSITY
Jenny, Allen - USDA, APHIS, NVSL
Williams, Elizabeth - UNIVERSITY OF WYOMING


Submitted to: Meeting Abstract
Publication Type: Abstract
Publication Acceptance Date: September 29, 2004
Publication Date: October 14, 2004
Citation: Hamir, A., Miller, J., Cutlip, R., Stack, M., Chaplin, M., Bartz, J., Jenny, A., Williams, E. 2004. Experimental Inoculation of Tme, Scrapie, and Cwd to Raccoons: An Update [abstract]. Animal Prion Diseases and the Americas. P. 79.

Technical Abstract: Raccoons (Procyon lotor) are omnivorous and their diet may include carrion. It is, therefore, possible that in the wild they may get exposed to carcasses of animals with transmissible spongiform encephalopathies (TSEs). To determine the susceptibility of raccoons to transmissible mink encephalopathy (TME), scrapie, and chronic wasting disease (CWD), each of these agents was inoculated intracerebrally into a group of 4 kits. Three uninoculated kits served as controls. All raccoons in the TME-inoculated group developed neurologic signs and were euthanized within 6 months post inoculation (PI). In the scrapie-inoculated group, 3 animals became sick and were euthanized between 18 - 22 PI. Although the fourth raccoon in this group did not show any clinical signs, it was euthanized at 24 months PI. At necropsy all clinically affected raccoons had extensive microscopic lesions of spongiform encephalopathy and protease-resistant prion protein (PrPres) was detected in the CNS by immunohistochemistry and Western blot. In the CWD-inoculated group, 1 raccoon was euthanized at 39 months PI because of severe cystitis. Its brain was negative for PrPres. At present, 5 years PI, the 3 remaining CWD-inoculated raccoons are alive and apparently healthy. They will be kept under observation for further period of 1 year (i.e 6 years PI) when the experiment will be terminated. These preliminary findings demonstrate that TME and scrapie can be transmitted to raccoons within 6 months and 2 years, respectively, whereas CWD cannot. Based on these incubation periods, it may be possible to differentiate these 3 TSEs. Such a laboratory model would be relatively simple, fast and inexpensive for strain-typing of unknown TSEs in the United States. Now that the relative susceptibiity to IC transmission of each TSE has been established, oral transmission studies of TSEs to raccoons are planned.


Last Modified: 07/14/2006


http://www.ars.usda.gov/research/publications/publications.htm?seq_no_115=167761


Research Project: Transmission, Differentiation, and Pathobiology of Transmissible Spongiform Encephalopathies
Location: Virus and Prion Diseases of Livestock

Title: Experimental Transmission of Transmissible Mink Encephalopathy (Tme) to Cattle by Intracerebral Inoculation


Authors

Hamir, Amirali
Kunkle, Robert
Miller, Janice - ARS RETIRED
Greenlee, Justin
Richt, Juergen


Submitted to: International Veterinary Vaccines and Diagnostics Conference
Publication Type: Abstract
Publication Acceptance Date: March 15, 2006
Publication Date: June 25, 2006
Citation: Hamir, A.N., Kunkle, R.A., Miller, J.M., Greenlee, J.J., Richt, J.A. 2006. Experimental Transmission of Transmissible Mink Encephalopathy (Tme) to Cattle by Intracerebral Inoculation [abstract]. 4th International Veterinary Vaccines and Diagnostics Conference. P. 89. Paper No. Po53.

Technical Abstract: To compare clinicopathological findings of transmissible mink encephalopathy (TME) with other transmissible spongiform encephalopathies (TSE, prion diseases) that have been shown to be experimentally transmissible to cattle (sheep scrapie, and chronic wasting disease, CWD), 2 groups of calves (n = 4 each) were intracerebrally inoculated with TME agents from 2 different sources (mink with TME and a bovine with TME). Two uninoculated calves served as controls. Within 15.3 months post inoculation (PI), all animals from both inoculated groups developed clinical signs of central nervous system (CNS) abnormality; their CNS tissues had microscopic spongiform encephalopathy (SE); and PrP**res was detected in their CNS tissues by immunohistochemistry (IHC) and Western blot (WB) techniques. These findings demonstrate that intracerebrally inoculated cattle not only amplify TME PrP**res but also develop clinical CNS signs and extensive lesions of SE. The latter has not been shown with other TSE agents (scrapie and CWD) similarly inoculated into cattle. The findings also suggest that the diagnostic techniques currently used for confirmation of bovine spongiform encephalopathy (BSE) would detect TME in cattle should it occur naturally. However, it would be a diagnostic challenge to differentiate TME in cattle from BSE. Our recent preliminary results indicate that WB may be able to differentiate between bovine TME and BSE.


http://www.ars.usda.gov/research/publications/publications.htm?seq_no_115=191825


Research Project: Transmission, Differentiation, and Pathobiology of Transmissible Spongiform Encephalopathies
Location: Virus and Prion Diseases of Livestock

Title: First and Second Cattle Passage of Transmissible Mink Encephalopathy (Tme) by Intracerebral Inoculation


Authors

Hamir, Amirali
Kunkle, Robert
Miller, Janice - ARS RETIRED
Bartz, J - CREIGHTON UNIVERSITY
Richt, Juergen


Submitted to: Veterinary Pathology
Publication Type: Peer Reviewed Journal
Publication Acceptance Date: August 12, 2005
Publication Date: March 1, 2006
Citation: Hamir, A.N., Kunkle, R.A., Miller, J.M., Bartz, J.C., Richt, J.A. 2006. First and Second Cattle Passage of Transmissible Mink Encephalopathy (Tme) by Intracerebral Inoculation. Veterinary Pathology. 43(2):118-126.

Interpretive Summary: Transmissible mink encephalopathy (TME) is a fatal neurologic disease. It is similar to bovine spongiform encephalopathy (BSE) or mad cow disease. To compare TME infection with other similar diseases in cattle, 2 groups of calves were inoculated in the brain with TME agents from 2 different sources. Two uninoculated calves served as controls. Within 15.3 months post inoculation, animals from both inoculated groups developed clinical signs of central nervous system (CNS) abnormality. Laboratory tests revealed lesions and presence of the TME agent in their tissues. Both findings could not be differentiated from those seen in BSE. Our findings also demonstrated that the laboratory tests that are currently used for BSE surveillance would detect TME in cattle should it occur naturally. However, it would be a diagnostic challenge to differentiate TME in cattle from BSE by clinical signs or laboratory tests that are currently available. Results of this study will have an impact on directing future research on TSEs to search for specific laboratory tests to differentiate BSE from TME in cattle.
Technical Abstract: To compare clinicopathological findings of transmissible mink encephalopathy (TME) with other transmissible spongiform encephalopathies (TSE, prion diseases) that have been shown to be experimentally transmissible to cattle (sheep scrapie, and chronic wasting disease, CWD), 2 groups of calves (n = 4 each) were intracerebrally inoculated with TME agents from 2 different sources (mink with TME and a bovine with TME). Two uninoculated calves served as controls. Within 15.3 months post inoculation (PI), animals from both inoculated groups developed clinical signs of central nervous system (CNS) abnormality; their CNS tissues had microscopic spongiform encephalopathy (SE); and PrPres was detected in their CNS tissues by immunohistochemistry (IHC) and Western blot (WB) techniques. These findings demonstrate that intracerebrally inoculated cattle not only amplify TME PrPres but also develop clinical CNS signs and extensive lesions of SE. The latter has not been shown with other TSE agents (scrapie and CWD) similarly inoculated into cattle. The findings also demonstrate that the diagnostic techniques currently used for bovine spongiform encephalopathy (BSE) surveillance would detect TME in cattle should it occur naturally. However, it would be a diagnostic challenge to differentiate TME in cattle from BSE by clinical signs, neuropathology, or the presence of PrPres by IHC and WB.

http://www.ars.usda.gov/research/publications/publications.htm?SEQ_NO_115=173819


SECTION ONE

EXECUTIVE SUMMARY

http://www.fda.gov/cvm/Documents/bse1.pdf


SECTION TWO

INTRODUCTION AND PROFILE

OF THE MEAT ANIMAL PRODUCING, SLAUGHTERING,

AND RENDERING INDUSTRIES

The U.S. Food and Drug Administration (FDA) is considering regulatory options to reduce

the risk of an outbreak of transmissible spongiform encephalopathies (TSE) in the United States.

In the United Kingdom, one form of TSE, bovine spongiform encephalopathy (BSE), is believed

to be linked to cattle feed containing rendered protein by-products from sheep and goats infected

with scrapie, a disease that is related to BSE.

The FDA regulatory actions will affect a spectrum of agricultural producers including

renderers, slaughterers, animal producers, and animal feed producers. After introducing the FDA

options under consideration (see Section 2.1), this discussion introduces the various industry

components and discusses their composition, size, and scale of economic activity. Among the

affected animal producers are cattle, sheep, and goat producers.

2.1 THE PROPOSED FDA REGULATION

FDA is considering five regulatory options:

# A prohibition on all mammalian protein in ruminant feed.

# A prohibition of all ruminant protein in ruminant feed.

# A prohibition on the inclusion of designated tissues in ruminant feed. This option

specifies that ruminant feed is not generally recognized as safe if it includes (1)

bovine brain, spinal cord, distal ileum, and eyes; (2) any and all protein that is

derived from any portions of the ovine (sheep family), caprine (goat family),

cervine (deer family), and mink; or (3) dead, dying, disabled, or diseased bovine.

# A prohibition on the inclusion of protein derived from sheep (including lamb),

goats, deer, elk, and mink in ruminant feed.

# A prohibition on the inclusion of protein derived from sheep (including lamb) and

goats in ruminant feed.

Under these prohibitions, any component of ruminant feed containing prohibited

ingredients will be considered adulterated within the meaning of the Federal Food, Drug, and

Cosmetic Act. The regulatory options would not place restrictions on the use of ruminant protein

by-products for uses other than as an ingredient in ruminant feed nor would they restrict the use of

ruminant derived fats and tallows.

2.2 PROFILE OF CATTLE RANCHERS

snip...

2.8 PROFILE OF MINK PRODUCERS

Mink are raised for their pelts and oil. Most mink farmers kill and pelt their own animals

once a year near the end of November or in early December. Once the pelts are removed, the fat is

then scrapped from the hide. This fat is used to manufacture mink oil that is sought for cosmetic

uses because of its hypoallergenic qualities and in leather treatments. The total value of mink

production in 1995 was $143 million, an increase of 72 percent from 1994.

In 1995, 446 mink farms produced a total of 2.69 million pelts (NASS, 1996b). Mink

producers vary in size but most are small operations. Mink farming is concentrated in Utah (130

2-11

farms), Wisconsin (77 farms), and Minnesota (52 farms). There has been recent consolidation

within the industry, with the number of farms decreasing by 8 percent from 1993 to 1994 and 3

percent from 1994 to 1995. The market price for mink pelts is subject to wide demand fluctuations

based on fashion and weather.

Once the pelt and fat are removed, the entire carcass is then rendered. Mink carcasses sent

to rendering (minus the pelt and fat) weigh an average of 2.5 pounds, so the total estimated offal

produced per year is 6.7 million pounds. Mink farmers are reported to have difficulty with getting

renderers to pick-up their material because of its low volume and the infrequency of offal

generation.

snip...

http://www.fda.gov/cvm/Documents/bse2.pdf

bse3

http://www.fda.gov/cvm/Documents/bse3.pdf

Re: Docket No. 04-047-1, Federal Measures To Mitigate BSE Risks:
Considerations for Further Action; Proposed Rule

snip...

Further, Wisconsin has over 60 mink ranches, whose main food source is also
meat from dead animals. Many mink ranchers collect and process dead
animals to feed their mink. Prohibiting dead animals from being used in
this manner may force many mink ranchers out of this multi-million dollar
industry.


https://web01.aphis.usda.gov/regpublic.nsf/168556f5aa7a82ba85256ed00044eb1f/3aa42066efdafc2487256f0a006bef00?OpenDocument

Thursday

June 5, 1997

Part II

Department of

Health and Human

Services

Food and Drug Administration

21 CFR Part 589

Substances Prohibited From Use in

Animal Food or Feed; Animal Proteins

Prohibited in Ruminant Feed; Final Rule

http://www.fda.gov/cvm/Images/6597bse.pdf

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 589

[Docket No. 2002N-0273] (formerly Docket No. 02N-0273)
RIN 0910-AF46


Substances Prohibited From Use in Animal Food or Feed

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is proposing to amend
the agency's regulations to prohibit the use of certain cattle origin
materials in the food or feed of all animals. These materials include
the following: The brains and spinal cords from cattle 30 months of age
and older, the brains and spinal cords from cattle of any age not
inspected and passed for human consumption, the entire carcass of
cattle not inspected and passed for human consumption if the brains and
spinal cords have not been removed, tallow that is derived from the
materials prohibited by this proposed rule that contains more than 0.15
percent insoluble impurities, and mechanically separated beef that is
derived from the materials prohibited by this proposed rule. These
measures will further strengthen existing safeguards designed to help
prevent the spread of bovine spongiform encephalopathy (BSE) in U.S.
cattle.

DATES: Submit written or electronic comments by December 20, 2005.
Submit written comments on the information collection provisions by
November 7, 2005.

http://www.fda.gov/OHRMS/DOCKETS/98fr/05-20196.htm

ECONOMIC IMPACTS OF _PROPOSED_

FDA REGULATORY CHANGES TO REGULATION OF ANIMAL FEEDS

DUE TO RISK OF BOVINE SPONGIFORM ENCEPHALOPATHY

FINAL REPORT

Contract No.

223-03-8500

Task Order 3

Submitted to:

Economics Staff

Office of Policy and Planning

Office of the Commissioner

Food and Drug Administration

Rockville, MD 20857

Submitted by:

Eastern Research Group, Inc.

110 Hartwell Ave.

Lexington, MA 02421

July 25, 2005

EXECUTIVE SUMMARY

SECTION ONE

FDA is considering a modification to its rules governing animal feed by supplementing or

expanding the 1997 rule restricting the feeding of mammalian protein (except for porcine and

equine protein) to ruminant animals. In the regulatory option under study in this report, FDA has

defined prohibited cattle material (PCM) and would prohibit it from use in all animal feeds.

PCM consists of the brain and spinal cord of:

• Slaughter cattle 30 months of age or older,

• All non-ambulatory disabled cattle,

• All cattle that died other than from slaughter, and

• Mechanically separated beef from cattle from which prohibited cattle materials (i.e., brain

and spinal cord) were not removed.

These materials are not to be used in animal feed. Additionally, tallow that contains any PCM is

considered PCM. All other tallow must meet purity requirements. No more than 0.15 percent

hexane-insoluble impurities can be contained in tallow used in feed under the option considered.

This study examines the impacts of this regulatory option on the affected agricultural and food

industries. In so doing, it extends previous research performed by ERG on several other

regulatory alternatives FDA is considering. In particular, ERG’s report of August 2004 examined

different versions of an extended feed ban. Those regulatory options would prohibit a larger

volume of cattle material from animal feed.

FDA’s PCM alternative will directly prohibit a small share of animal offal from production of

meat and bone meal (MBM) and tallow. The brain and spinal cord of an average slaughter cow

weighs only 1.3 lbs. Slaughterers and renderers both have or can acquire the capability to remove

such materials from the animals they process. Nevertheless, both slaughterers and renderers will

often remove a larger share of the animal offal because (1) slaughterers generally cannot

distinguish the age of an animal sufficiently early to affect processing, (2) independent renderers

might require that their slaughter clients remove the entire skull for all animals in order to be

sure that no brain materials are included in the offal they pickup, and (3) independent renderers

that pick up deads and downers1 might have to remove the entire spinal column (not just the

spinal cord) if the carcass has deteriorated, as is often the case in summer.

The eventual disposition of PCM under this regulatory structure is uncertain. Some landfills

might accept modest quantities of brain and spinal cords without further processing. More likely,

some new disposal infrastructure will need to evolve in which PCM materials are processed

through chemical digester units or rendered prior to disposal. Newly emergent commercial

entities or existing renderers might fill this gap. Because the volumes of materials generated is

not sufficiently large for efficient processing (relative to the flows for other agricultural materials

1 The term downer is used, although the animal must be humanely euthanized prior to transporting.

1-3

like renderable animal offal), disposal or rendering for disposal charges for these materials will

exceed current costs for rendering. ERG used an assumed charge of $12 per hundredweight for

disposal or rendering for disposal.

Using the assumptions and estimates of the PCM quantities withdrawn from productive use, the

overall impact of the regulatory option on slaughtering and rendering processes is modest. The

amount of material removed from the rendering stream amounts to 0.1 percent of MBM

production and less than 0.1 percent of tallow production.

ERG also estimates the costs of meeting tallow purity requirements and the costs for renderers to

add equipment and labor to remove PCM from cattle prior to processing deads and downers.

Total compliance costs are estimated at $15.9 million, as shown in Table ES-1.

FULL TEXT 45 PAGES ;

http://www.fda.gov/OHRMS/DOCKETS/98fr/02n-0273-bkg0001-44-Ref-25-.pdf

ECONOMIC IMPACTS OF _ALTERNATIVE_

CHANGES TO THE FDA REGULATION OF ANIMAL FEEDS TO

ADDRESS THE RISK OF

BOVINE SPONGIFORM ENCEPHALOPATHY

FINAL REPORT

Contract No.

223-98-8002

Task Order 12

Submitted to

Economics Staff

Office of Policy and Planning

Office of the Commissioner

Food and Drug Administration

Rockville, MD 20857

Submitted by:

Eastern Research Group, Inc.

110 Hartwell Ave.

Lexington, MA 02421

July 25, 2005

EXECUTIVE SUMMARY

FDA considered modifying its rules governing animal feed by supplementing or expanding the

1997 rule restricting the feeding of mammalian protein (except for porcine and equine protein) to

ruminant animals. As one alternative, FDA considered prohibiting the following:

• Specified risk materials (SRM),

• Mechanically separated (MS) beef,

• Materials from dead or non-ambulatory cattle or from cattle that died by means other than

slaughter at an inspected slaughter establishment, and

• Tallow containing more than 0.15 percent hexane-insoluble impurities from inclusion in

any animal feed.

This study examines the impacts of these items on the affected agricultural and food industries.

snip....

FULL TEXT 143 PAGES ;

http://www.fda.gov/OHRMS/DOCKETS/98fr/02n-0273-bkg0001-50-Ref-31.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

Executive Summary

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

Results in Brief This report evaluates elements of the interlocking safeguards in place to protect United States (U.S.) beef from Bovine Spongiform Encephalopathy, widely known as BSE or "mad cow disease." Since 1990, the U.S. Department of Agriculture (USDA), Animal and Plant Health Inspection Service (APHIS), has led a multi-agency effort to monitor and prevent BSE from entering the food supply. After discovering a BSE-positive cow in December 2003, APHIS expanded its BSE surveillance program. To further protect the food supply, USDA banned materials identified as being at risk of carrying BSE (specified risk materials (SRM)), such as central nervous system tissue. As part of this effort, USDA’s Food Safety and Inspection Service (FSIS) required beef slaughter and processing facilities to incorporate controls for handling such materials into their operational plans. Onsite FSIS inspectors also inspect cattle for clinical signs in order to prevent diseased animals from being slaughtered for human consumption. To evaluate the effectiveness of the safeguards, we assessed APHIS’ implementation of the expanded surveillance program, as well as FSIS’ controls to prevent banned SRMs from entering the food supply.

In June 2004, APHIS implemented its expanded surveillance program; participation by industry in this surveillance program is voluntary. As of May 2005, over 350,000 animals were sampled and tested for BSE. To date, two animals tested positive for BSE; one tested positive after implementation of the expanded surveillance program.

USDA made significant efforts to implement the expanded BSE surveillance program. Much needed to be done in a short period of time to establish the necessary processes, controls, infrastructure, and networks to assist in this effort. In addition, extensive outreach and coordination was undertaken with other Federal, State, and local entities, private industry, and laboratory and veterinary networks. This report provides an assessment as to the progress USDA made in expanding its surveillance effort and the effectiveness of its controls and processes. This report also discusses the limitations of its program and data in assessing the prevalence of BSE in the U.S. herd.

Surveillance Goals and Objectives

In March 2004, USDA published its plan to expand the BSE surveillance program. The plan’s goal was to collect samples from as many adult1 cattle from the high-risk population as possible in 12-18 months while ensuring that there was statistically appropriate geographical representation of the adult cattle population in the United States. Overall, USDA designed the program to define whether BSE was actually present in the U.S. cattle population and if so, to what level.

When USDA published its plan, Office of Inspector General (OIG) was examining the pre-expansion program. In anticipation of the coming changes, we reviewed the plan in order to determine if its design would allow the Department to reach statistically valid conclusions about the presence and level of BSE. Since the implementation plan had not been finalized, we provided recommendations for USDA to consider as they moved forward with implementing an expanded surveillance program. In August 2004, we released our report, Animal and Plant Health Inspection Service and Food Safety and Inspection Service, Bovine Spongiform Encephalopathy (BSE) Surveillance Program – Phase I (Report No. 50601-9-KC), which discussed our observations of the challenges USDA faced in meeting its stated goals and made 19 recommendations for USDA to consider as it moved forward with implementation. Our prior report primarily focused on (1) the potential for unwarranted statistical conclusions to be drawn from the data USDA planned to collect, and (2) the challenges in identifying and testing high-risk cattle. In response to our report, APHIS agreed to disclose the limitations of the data and the assumptions made and its impact on any statistical representations regarding the prevalence of BSE in order to obviate misinterpretation.

We reviewed the specific corrective actions APHIS and FSIS agreed to take in response to prior audit recommendations during this audit. In this report, we discuss the specific areas where corrective actions were not fully effective in addressing our concerns in the following areas: obtaining representative samples, identifying and obtaining samples from the high-risk surveillance streams, and completeness and accuracy of program data.

APHIS has provided OIG unpublished drafts of its preliminary analysis, which included various statistical approaches to determining the prevalence of BSE. In general, each approach mitigates some, but not all of the limitations associated with its data and underlying assumptions in the design and implementation of its surveillance program. Some of the approaches also

1 FSIS considers bulls and cows to be mature cattle with cows ordinarily having given birth to one or more calves. FSIS defines SRMs to be present in cattle 30 months of age or older, while APHIS defines its target population for BSE sampling to be over 30 months of age. Dentition is used to estimate the age ranges of cattle. Dentition is the development of teeth and their arrangement in the mouth.

USDA/OIG-A/50601-10-KC/ Page iii

introduce new challenges because any conclusions are extremely sensitive to the accuracy of the underlying data. The accuracy of the underlying data is also critical to the development of a future maintenance surveillance program. We cannot fully assess any of the approaches being considered by APHIS since it has not finalized its analysis. In Finding 1, however, we do offer several observations for APHIS to consider as it develops its conclusions about the prevalence of BSE in the U.S. cattle population.

Inherent Limitations in Identifying and Testing High-Risk Cattle

APHIS obtained significantly more samples for testing than they originally anticipated would be needed to achieve its stated level of confidence in estimating the prevalence of BSE in the U.S. herd. Because of the voluntary nature of its program, however, we could not determine how successful APHIS was in obtaining a representative proportion of high-risk cattle for testing. Our prior report recognized the significant challenges for APHIS to obtain samples from the high-risk population because of the inherent problems with obtaining voluntary compliance and transporting carcasses for testing. APHIS took steps to obtain facilitated pathways, by entering into over 100 agreements, to collect and test brain samples for BSE. However, using USDA published data that estimates the distribution of the cattle population, as well as those that died or became nonambulatory, we could not determine whether APHIS achieved either geographical representation or representation of the desired surveillance stream (clinical suspects, fallen stock, casualty slaughter fallen stock, and routine slaughter). Findings 1 and 2 present the conditions noted that impact this evaluation.

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.

Controls (Firewalls) to Prevent BSE in the Food Supply

USDA instituted proactive procedures to prevent tissues and products that could possibly contain the infective agent for BSE from entering the food supply. FSIS performs inspections on cattle before slaughter (ante mortem) to observe clinical signs that may indicate a central nervous system disorder or other signs that may be associated with BSE. Such animals are condemned and prohibited from slaughter for human consumption. FSIS also identified high-risk beef tissue and products as SRMs, and banned them from the food supply. FSIS inspects slaughter processes to verify that slaughterhouses have incorporated controls for handling SRMs into their operational plans; adequate procedures must be in place for removing, segregating, and disposing of SRMs.

OIG reviewed the SRM plans of several establishments, observed FSIS inspection procedures, and evaluated the effectiveness of controls during the slaughter process. We did not identify SRMs entering the food supply. However, due to the lack of adequate records, we could not determine whether SRM procedures were followed and/or were adequate in 9 of

2 For purposes of this report, the term renderers also includes pet food manufacturers and plants that handle dead, dying, disabled, or diseased livestock.

3 9 CFR 320.5, states that every person that engages in business in or for commerce, as a meat broker, renderer, or animal food manufacturer … shall register with the Administrator [of FSIS].

12 establishments visited during the audit. There is no requirement in the United States for the age of animals to be recorded, therefore, APHIS and FSIS rely on meat establishments to determine the age of cattle slaughtered using documentation or dentition. SRM restrictions apply predominantly to cattle 30 months of age or older. FSIS periodically checks the accuracy of age determinations through dentition; however, we could not determine how often these checks are made. We found that improvements can be made in the following areas.


• FSIS approved an alternate ante mortem inspection procedure that limited the number of cattle subject to inspection. FSIS discontinued this procedure during the audit.


• FSIS does not have an information system capable of readily identifying the scope of, and trends in, noncompliance violations relating to SRMs.


• Most of the establishments reviewed did not have adequate SRM plans, and FSIS did not always identify these deficiencies.

• Several of the establishments did not comply with their SRM plans and/or maintain records to support that they follow their plans.

FSIS has addressed the specific cases of noncompliance identified during the audit. Findings 5 through 9 discuss our assessment of the effectiveness of USDA’s firewalls.

Other Program Administration Issues

FSIS and APHIS did not maintain current and comprehensive listings of renderers2 and related businesses. These entities are required to register with FSIS as a condition of engaging in business.3 As a result, should serious animal diseases be detected in the United States, USDA’s ability to quickly determine and trace the source of infections to prevent the spread of the disease could be impaired. Also, APHIS could not use the registrations to identify potential sources to mitigate geographical gaps in BSE testing. We discuss the details of this issue in Finding 11.

We also determined that an APHIS area office paid costs for sampling and carcass transportation, storage, and disposal that exceeded national cost recovery guidelines and/or that were ineligible for reimbursement. The area office entered into 10 reimbursable agreements before national office cost recovery guidelines had been issued but did not adjust the agreements afterwards although instructed to do so by the national office. Instead, the area office included the questionable costs in amounts proposed (by

USDA/OIG-A/50601-10-KC/ Page vi

third parties) in other allowable cost categories. The area office official stated he changed supporting records because he believed he should honor the prior negotiated costs. As a result, at least $1.2 million of about $11.2 million paid were unsupported program costs. Finding 12 more fully examines the unsupported costs and why they went undiscovered.

The expanded stage of USDA’s BSE surveillance program is nearing its end. Accordingly, it is vital that the conditions summarized above be considered as USDA uses the data gathered to design an effective BSE surveillance maintenance program and to report its assessment of the prevalence of BSE in the U.S. herd. In particular, APHIS must develop testing protocols which are grounded in science and flexible enough to adapt to changing circumstances. For its part, FSIS must ensure that it effectively monitors SRM handling practices to ensure they comply with Federal regulations. Implemented, these management controls will help USDA continue to effectively safeguard the U.S. beef supply for consumers.

snip....

full text 130 pages ;

http://www.usda.gov/oig/webdocs/50601-10-KC.pdf


SEE STEADY INCREASE IN SPORADIC CJD IN THE USA FROM
1997 TO 2004. SPORADIC CJD CASES TRIPLED, and that is
with a human TSE surveillance system that is terrible
flawed. in 1997 cases of the _reported_ cases of cjd
were at 54, to 163 _reported_ cases in 2004. see stats
here;

p.s. please note the 47 PENDING CASES to Sept. 2005

p.s. please note the 2005 Prion D. total 120(8)
8=includes 51 type pending, 1 TYPE UNKNOWN ???

p.s. please note sporadic CJD 2002(1) 1=3 TYPE UNKNOWN???

p.s. please note 2004 prion disease (6) 6=7 TYPE
UNKNOWN???


http://www.cjdsurveillance.com/resources-casereport.html


Finally, with a NATIONWIDE mad cow feed recall going on as we speak of some 10,878.06 TONS, it would seem prudent that that any further strengthening of any rules should include making the old rules enforceable ;

MAD COW FEED RECALL USA EQUALS 10,878.06 TONS NATIONWIDE
Sun Jul 16, 2006 09:22
71.248.128.67


RECALLS AND FIELD CORRECTIONS: VETERINARY MEDICINE -- CLASS II
______________________________
PRODUCT
a) PRO-LAK, bulk weight, Protein Concentrate for Lactating Dairy Animals,
Recall # V-079-6;
b) ProAmino II, FOR PREFRESH AND LACTATING COWS, net weight 50lb (22.6 kg),
Recall # V-080-6;
c) PRO-PAK, MARINE & ANIMAL PROTEIN CONCENTRATE FOR USE IN ANIMAL
FEED, Recall # V-081-6;
d) Feather Meal, Recall # V-082-6
CODE
a) Bulk
b) None
c) Bulk
d) Bulk
RECALLING FIRM/MANUFACTURER
H. J. Baker & Bro., Inc., Albertville, AL, by telephone on June 15, 2006 and by press release on June 16, 2006. Firm initiated recall is ongoing.
REASON
Possible contamination of animal feeds with ruminent derived meat and bone meal.
VOLUME OF PRODUCT IN COMMERCE
10,878.06 tons
DISTRIBUTION
Nationwide

END OF ENFORCEMENT REPORT FOR July 12, 2006

###

http://www.fda.gov/bbs/topics/enforce/2006/ENF00960.html


New Orleans District
297 Plus Park Blvd.
Nashville, TN 37217

Telephone: 615-781-5380
Fax: 615-781-5391

May 17, 2006

WARNING LETTER NO. 2006-NOL-06

FEDERAL EXPRESS
OVERNIGHT DELIVERY

Mr. William Shirley, Jr., Owner
Louisiana.DBA Riegel By-Products
2621 State Street
Dallas, Texas 75204

Dear Mr. Shirley:

On February 12, 17, 21, and 22, 2006, a U.S. Food & Drug Administration (FDA) investigator inspected your rendering plant, located at 509 Fortson Street, Shreveport, Louisiana. The inspection revealed significant deviations from the requirements set forth in Title 21, Code of Federal Regulations, Part 589.2000 [21 CFR 589.2000], Animal Proteins Prohibited in Ruminant Feed. This regulation is intended to prevent the establishment and amplification of Bovine Spongiform Encephalopathy (BSE). You failed to follow the requirements of this regulation; products being manufactured and distributed by your facility are misbranded within the meaning of Section 403(a)(1) [21 USC 343(a)(1)] of the Federal Food, Drug, and Cosmetic Act (the Act).

Our investigation found you failed to provide measures, including sufficient written procedures, to prevent commingling or cross-contamination and to maintain sufficient written procedures [21 CFR 589.2000(e)] because:

You failed to use clean-out procedures or other means adequate to prevent carryover of protein derived from mammalian tissues into animal protein or feeds which may be used for ruminants. For example, your facility uses the same equipment to process mammalian and poultry tissues. However, you use only hot water to clean the cookers between processing tissues from each species. You do not clean the auger, hammer mill, grinder, and spouts after processing mammalian tissues.

You failed to maintain written procedures specifying the clean-out procedures or other means to prevent carryover of protein derived from mammalian tissues into feeds which may be used for ruminants.

As a result . the poultry meal you manufacture may contain protein derived from mammalian tissues prohibited in ruminant feed. Pursuant to 21 CFR 589.2000(e)(1)(i), any products containing or may contain protein derived from mammalian tissues must be labeled, "Do not feed to cattle or other ruminants." Since you failed to label a product which may contain protein derived from mammalian tissues with the required cautionary statement. the poultry meal is misbranded under Section 403(a)(1) [21 USC 343(a)(1)] of the Act.

This letter is not intended as an all-inclusive list of violations at your facility. As a manufacturer of materials intended for animal feed use, you are responsible for ensuring your overall operation and the products you manufacture and distribute are in compliance with the law. You should take prompt action to correct these violations, and you should establish a system whereby violations do not recur. Failure to promptly correct these violations may result in regulatory action, such as seizure and/or injunction, without further notice.

You should notify this office in writing within 15 working days of receiving this letter, outlining the specific steps you have taken to bring your firm into compliance with the law. Your response should include an explanation of each step taken to correct the violations and prevent their recurrence. If corrective action cannot be completed within 15 working days, state the reason for the delay and the date by which the corrections will be completed. Include copies of any available documentation demonstrating corrections have been made.

Your reply should be directed to Mark W. Rivero, Compliance Officer, U.S. Food and Drug Administration, 2424 Edenborn Avenue, Suite 410, Metairie, Louisiana 70001. If you have questions regarding any issue in this letter, please contact Mr. Rivero at (504) 219-8818, extension 103.

Sincerely,

/S

Carol S. Sanchez
Acting District Director
New Orleans District


http://www.fda.gov/foi/warning_letters/g5883d.htm

May 9, 2006

April 2006 Update on Feed Enforcement Activities to Limit the Spread of BSE

To help prevent the establishment and amplification of BSE through feed in the United States, FDA implemented a final rule that prohibits the use of most mammalian protein in feeds for ruminant animals. This rule, Title 21 Part 589.2000 of the Code of Federal Regulations, here called the Ruminant Feed Ban, became effective on August 4, 1997.

This is an update on FDA enforcement activities regarding the ruminant feed ban. FDA's CVM has assembled data from the inspections that have been conducted AND whose final inspection report has been recorded in the FDA's inspection database as of April 29, 2006. As of April 29, 2006, FDA had received over 44,000 inspection reports. The majority of these inspections (around 68%) were conducted by State feed safety officials, with the remainder conducted by FDA officials.

Inspections conducted by FDA or State investigators are classified to reflect the compliance status at the time of the inspection based upon the objectionable conditions documented. These inspection conclusions are reported as Official Action Indicated (OAI), Voluntary Action Indicated (VAI), or No Action Indicated (NAI).

An OAI inspection classification occurs when significant objectionable conditions or practices were found and regulatory sanctions are warranted in order to address the establishment's lack of compliance with the regulation. An example of an OAI inspection classification would be findings of manufacturing procedures insufficient to ensure that ruminant feed is not contaminated with prohibited material. Inspections classified with OAI violations will be promptly re-inspected following the regulatory sanctions to determine whether adequate corrective actions have been implemented.

A VAI inspection classification occurs when objectionable conditions or practices were found that do not meet the threshold of regulatory significance, but do warrant advisory actions to inform the establishment of findings that should be voluntarily corrected. Inspections classified with VAI violations are more technical violations of the Ruminant Feed Ban. These include provisions such as minor recordkeeping lapses and conditions involving non-ruminant feeds.

An NAI inspection classification occurs when no objectionable conditions or practices were found during the inspection or the significance of the documented objectionable conditions found does not justify further actions.
The results to date are reported here both by “segment of industry” and “in total”. NOTE – A single firm can operate as more than one firm type. As a result, the categories of the different industry segments are not mutually exclusive.

RENDERERS

These firms are the first to handle and process (i.e., render) animal proteins and to send these processed materials to feed mills and/or protein blenders for use as a feed ingredient.

Number of active firms whose initial inspection has been reported to FDA – 266


Number of active firms handling materials prohibited from use in ruminant feed – 175 (66% of those active firms inspected)


Of the 175 active firms handling prohibited materials, their most recent inspection revealed that:

2 firms (1.1%) were classified as OAI


4 firms (2.3%) were classified as VAI

LICENSED FEED MILLS

FDA licenses these feed mills to produce medicated feed products. The license is required to manufacture and distribute feed using certain potent drug products, usually those requiring some pre-slaughter withdrawal time. This licensing has nothing to do with handling prohibited materials under the feed ban regulation. A medicated feed license from FDA is not required to handle materials prohibited under the Ruminant Feed Ban.

Number of active firms whose initial inspection has been reported to FDA – 1,092


Number of active firms handling materials prohibited from use in ruminant feed – 430 (39% of those active firms inspected)


Of the 430 active firms handling prohibited materials, their most recent inspection revealed that:

0 firms (0%) were classified as OAI


5 firms (1.2%) were classified as VAI

FEED MILLS NOT LICENSED BY FDA

These feed mills are not licensed by the FDA to produce medicated feeds.

Number of active firms whose initial inspection has been reported to FDA – 5,128


Number of active firms handling materials prohibited from use in ruminant feed – 2,176 (42% of those active firms inspected)

Of the 2,176 active firms handling prohibited materials, their most recent inspection revealed that:

0 firms (0%) were classified as OAI


36 firms (1.7%) were classified as VAI

PROTEIN BLENDERS

These firms blend rendered animal protein for the purpose of producing quality feed ingredients that will be used by feed mills.

Number of active firms whose initial inspection has been reported to FDA -- 340


Number of active firms handling materials prohibited from use in ruminant feed – 162 (48% of those active firms inspected)


Of the 162 active firms handling prohibited materials, their most recent inspection revealed that:

0 firms (0%) were classified as OAI


3 firms (1.9%) were classified as VAI

RENDERERS, FEED MILLS, AND PROTEIN BLENDERS

This category includes only those firms that actually use prohibited material to manufacture, process, or blend animal feed or feed ingredients.

Number of active renderers, feed mills, and protein blenders whose initial inspection has been reported to FDA – 6,558


Number of active renderers, feed mills, and protein blenders processing with prohibited materials – 491 (7.5%

Of the 491 of active renderers, feed mills, and protein blenders processing with prohibited materials, their most recent inspection revealed that:

2 firms (0.4%) were classified as OAI


19 firms (3.9%) were classified as VAI

OTHER FIRMS INSPECTED

Examples of such firms include ruminant feeders, on-farm mixers, pet food manufacturers, animal feed salvagers, distributors, retailers, and animal feed transporters.

Number of active firms whose initial inspection has been reported to FDA – 14,627


Number of active firms handling materials prohibited from use in ruminant feed – 4,314 (29% of those active firms inspected)


Of the 4,314 active firms handling prohibited materials, their most recent inspection revealed that:

3 firms (0.1%) were classified as OAI


117 firms (2.7%) were classified as VAI

TOTAL FIRMS

Note that a single firm can be reported under more than one firm category; therefore, the summation of the individual OAI/VAI firm categories will be more than the actual total number of OAI/VAI firms, as presented below.

Number of active firms whose initial inspection has been reported to FDA – 17,454


Number of active firms handling materials prohibited from use in ruminant feed – 5,103 (29% of those active firms inspected)


Of the 5,103 active firms handling prohibited materials, their most recent inspection revealed that:

5 firms (0.1%) were classified as OAI


126 firms (2.5%) were classified as VAI


--------------------------------------------------------------------------------

Issued by:
FDA, Center for Veterinary Medicine,
Communications Staff, HFV-12
7519 Standish Place, Rockville, MD 20855
Telephone: (240) 276-9300 FAX: (240) 276-9115
Internet Web Site: http://www.fda.gov/cvm

http://www.fda.gov/cvm/CVM_Updates/BSE0506.htm

Subject: 15,323 TONS OF POTENTIAL TAINTED TSE RUMINANT PROTEIN WITHOUT MAD COW FEED WARNING IN CIRCULATION 4 STATES
Date: November 10, 2005 at 2:05 pm PST


PRODUCT
a) Bulk nonmedicated custom swine and poultry feeds,
Recall # V-006-6;
b) Bulk medicated swine and poultry feeds, Recall # V-007-6
CODE
N/A
RECALLING FIRM/MANUFACTURER
Gold Eagle Cooperative, Goldfield, IA, by telephone or visit beginning August 30, 2005. Firm initiated recall is complete.
REASON
Swine and poultry feeds which may contain prohibited material are not labeled with the warning statement not to feed to cattle or other ruminants.
VOLUME OF PRODUCT IN COMMERCE
Approx. 15,323.68 tons of nonmedicated and medicated feed
DISTRIBUTION
IA, GA, MD, and MN

______________________________


http://www.fda.gov/bbs/topics/enforce/2005/ENF00925.html

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. ...

snip...


http://www.fda.gov/bbs/topics/NEWS/2001/NEW00752.html

WE know now, and we knew decades ago, that 5.5 grams of suspect feed in TEXAS was enough to kill 100 cows.


look at the table and you'll see that as little as 1 mg (or 0.001 gm) caused 7% (1 of 14) of the cows to come down with BSE;


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.


snip...


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


2

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


Re: BSE .1 GRAM LETHAL NEW STUDY SAYS via W.H.O. Dr Maura Ricketts

[BBC radio 4 FARM news]

http://www.maddeer.org/audio/BBC4farmingtoday2_1_03.ram

http://www.fda.gov/ohrms/dockets/ac/03/slides/3923s1_OPH.htm


2) Infectious dose:

To cattle: 1 gram of infected brain material (by oral ingestion)

http://www.inspection.gc.ca/english/sci/bio/bseesbe.shtml

Terry S. Singeltary Sr.

P.O. Box 42

Bacliff, Texas USA 77518

[Docket No. 03-025IFA] FSIS Prohibition of the Use of Specified Risk Materials for Human Food and Requirement for the Disposition of Non-Ambulatory Disabled Cattle

03-025IFA
03-025IFA-2
Terry S. Singeltary


Page 1 of 17

From: Terry S. Singeltary Sr. [flounder9@verizon.net]

Sent: Thursday, September 08, 2005 6:17 PM

To: fsis.regulationscomments@fsis.usda.gov

Subject: [Docket No. 03-025IFA] FSIS Prohibition of the Use of Specified Risk Materials for Human Food and Requirements

for the Disposition of Non-Ambulatory Disabled Cattle

Greetings FSIS,

I would kindly like to submit the following to [Docket No. 03-025IFA] FSIS Prohibition of the Use of Specified Risk Materials for Human Food and

Requirements for the Disposition of Non-Ambulatory Disabled Cattle

THE BSE/TSE SUB CLINICAL Non-Ambulatory Disabled Cattle

Broken bones and such may be the first signs of a sub clinical BSE/TSE Non-Ambulatory Disabled Cattle ;

SUB CLINICAL PRION INFECTION

MRC-43-00

Issued: Monday, 28 August 2000

NEW EVIDENCE OF SUB-CLINICAL PRION INFECTION: IMPORTANT RESEARCH

FINDINGS RELEVANT TO CJD AND BSE


Terry S. Singeltary Sr.

P.O. Box 42

Bacliff, Texas USA 77518

9/13/2005

http://www.fsis.usda.gov/OPPDE/Comments/03-025IFA/03-025IFA-2.pdf


========================================================

========================================================

OLD TSS SUBMISSIONS;

Docket No, 04-047-l Regulatory Identification No. (RIN) 091O-AF46 NEW BSE SAFEGUARDS (comment submission)

https://web01.aphis.usda.gov/regpublic.nsf/0/eff9eff1f7c5cf2b87256ecf000df08d?OpenDocument

Docket No. 03-080-1 -- USDA ISSUES PROPOSED RULE TO ALLOW LIVE ANIMAL
IMPORTS FROM CANADA


https://web01.aphis.usda.gov/BSEcom.nsf/0/b78ba677e2b0c12185256dd300649f9d?OpenDocument&AutoFramed


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

PDF]Freas, William TSS SUBMISSION

File Format: PDF/Adobe Acrobat -

Page 1. J Freas, William From: Sent: To: Subject: Terry S. Singeltary

Sr. [flounder@wt.net] Monday, January 08,200l 3:03 PM freas ...

http://www.fda.gov/ohrms/dockets/ac/01/slides/3681s2_09.pdf

Asante/Collinge et al, 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;

http://www.fda.gov/ohrms/dockets/ac/03/slides/3923s1_OPH.htm

Docket Management Docket: 96N-0417 - Current Good Manufacturing Practice
in Manufacturing, Packing, or Holding Dietary Ingredients a
Comment Number: EC -2
Accepted - Volume 7

http://www.fda.gov/ohrms/dockets/dailys/03/Mar03/031403/96N-0417-EC-2.htm


[PDF] Appendices to PL107-9 Inter-agency Working Group Final Report 1-1
File Format: PDF/Adobe Acrobat - View as HTML
Agent, Weapons of Mass Destruction Operations Unit Federal Bureau of
those who provided comments in response to Docket No. ...
Meager 8/18/01 Terry S. Singeltary Sr ...


http://www.aphis.usda.gov/lpa/pubs/pubs/PL107-9_Appen.pdf

Docket No. 2003N-0312 Animal Feed Safety System [TSS SUBMISSION]

http://www.fda.gov/ohrms/dockets/dockets/03n0312/03N-0312_emc-000001.txt

# Docket No: 02-088-1 RE-Agricultural Bioterrorism Protection Act of
2002; [TSS SUBMISSION ON POTENTIAL FOR BSE/TSE & FMD 'SUITCASE BOMBS'] -
TSS 1/27/03 (0)

Docket Management

Docket: 02N-0276 - Bioterrorism Preparedness; Registration of Food Facilities, Section 305
Comment Number: EC-254 [TSS SUBMISSION]

http://www.fda.gov/ohrms/dockets/dockets/02n0276/02N-0276-EC-254.htm


Dockets Entered On October 2, 2003 Table of Contents, Docket #,
Title, 1978N-0301,

OTC External Analgesic Drug Products, ... EMC 7, Terry S. Singeltary Sr.
Vol #: 1, ...

http://www.fda.gov/ohrms/dockets/dailys/03/oct03/100203/100203.htm


Daily Dockets Entered on 02/05/03

DOCKETS ENTERED on 2/5/03. ... EMC 4 Terry S. Singeltary Sr. Vol#: 2.
... Vol#: 1.

03N-0009 Federal Preemption of State & Local Medical Device Requireme. ...


http://www.fda.gov/ohrms/dockets/dailys/03/Feb03/020503/020503.htm


Docket Management

Docket: 02N-0370 - Neurological Devices; Classification of Human Dura Mater

Comment Number: EC -1

Accepted - Volume 1


http://www.fda.gov/ohrms/dockets/dailys/03/Jan03/012403/8004be11.html


http://www.fda.gov/ohrms/dockets/dailys/03/Jan03/012403/8004bdfe.html


http://www.fda.gov/ohrms/dockets/dailys/03/Jan03/012403/8004bdfc.html


Daily Dockets - 04/10/03

... 00D-1662 Use of Xenotransplantation Products in Humans.
EMC 98 Terry S. Singeltary Sr. Vol#: 3. 01F ...
http://www.fda.gov/ohrms/dockets/dailys/03/Apr03/041003/041003.htm - 05-20-2003
- Cached


2003D-0186
Guidance for Industry: Use of Material From Deer and Elk In Animal Feed


EMC 1
Terry S. Singeltary Sr.
Vol #:
1

http://www.fda.gov/ohrms/dockets/dailys/03/Jun03/060903/060903.htm


2003D-0186
Guidance for Industry: Use of Material From Deer and Elk In Animal Feed


EMC 7
Terry S. Singeltary Sr.
Vol #:
1

2003D-0186
Guidance for Industry: Use of Material From Deer and Elk In Animal Feed


EMC 7
Terry S. Singeltary Sr.
Vol #:
1


http://www.fda.gov/ohrms/dockets/dailys/03/oct03/100203/100203.htm

01N-0423 Substances Prohibited from use in animal food/Feed Ruminant

APE 5 National Renderers Association, Inc. Vol#: 2

APE 6 Animal Protein Producers Industry Vol#: 2

APE 7 Darling International Inc. Vol#: 2

EMC 1 Terry S. Singeltary Sr. Vol#: 3

http://www.fda.gov/ohrms/dockets/dailys/01/Oct01/101501/101501.htm

Send Post-Publication Peer Review to journal:


Re: RE-Monitoring the occurrence of emerging forms of Creutzfeldt-Jakob

disease in the United States


Email Terry S. Singeltary:


flounder@wt.net

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

LANCET INFECTIOUS DISEASE JOURNAL


Volume 3, Number 8 01 August 2003


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.


49-year-old Singeltary is one of a number of people who have remained

largely unsatisfied after being told that a close relative died from a

rapidly progressive dementia compatible with spontaneous

Creutzfeldt-Jakob disease (CJD). So he decided to gather hundreds of

documents on transmissible spongiform encephalopathies (TSE) and

realised that if Britons could get variant CJD from bovine spongiform

encephalopathy (BSE), Americans might get a similar disorder from

chronic wasting disease (CWD)the relative of mad cow disease seen among

deer and elk in the USA. Although his feverish search did not lead him

to the smoking gun linking CWD to a similar disease in North American

people, it did uncover a largely disappointing situation.


Singeltary was greatly demoralised at the few attempts to monitor the

occurrence of CJD and CWD in the USA. Only a few states have made CJD

reportable. Human and animal TSEs should be reportable nationwide and

internationally, he complained in a letter to the Journal of the

American Medical Association (JAMA 2003; 285: 733). I hope that the CDC

does not continue to expect us to still believe that the 85% plus of all

CJD cases which are sporadic are all spontaneous, without route or source.


Until recently, CWD was thought to be confined to the wild in a small

region in Colorado. But since early 2002, it has been reported in other

areas, including Wisconsin, South Dakota, and the Canadian province of

Saskatchewan. Indeed, the occurrence of CWD in states that were not

endemic previously increased concern about a widespread outbreak and

possible transmission to people and cattle.


To date, experimental studies have proven that the CWD agent can be

transmitted to cattle by intracerebral inoculation and that it can cross

the mucous membranes of the digestive tract to initiate infection in

lymphoid tissue before invasion of the central nervous system. Yet the

plausibility of CWD spreading to people has remained elusive.


Part of the problem seems to stem from the US surveillance system. CJD

is only reported in those areas known to be endemic foci of CWD.

Moreover, US authorities have been criticised for not having performed

enough prionic tests in farm deer and elk.


Although in November last year the US Food and Drug Administration

issued a directive to state public-health and agriculture officials

prohibiting material from CWD-positive animals from being used as an

ingredient in feed for any animal species, epidemiological control and

research in the USA has been quite different from the situation in the

UK and Europe regarding BSE.


Getting data on TSEs in the USA from the government is like pulling

teeth, Singeltary argues. You get it when they want you to have it,

and only what they want you to have.


Norman Foster, director of the Cognitive Disorders Clinic at the

University of Michigan (Ann Arbor, MI, USA), says that current

surveillance of prion disease in people in the USA is inadequate to

detect whether CWD is occurring in human beings; 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.

Ali Samii, a neurologist at Seattle VA Medical Center who recently

reported the cases of three hunterstwo of whom were friendswho died

from pathologically confirmed CJD, says that at present there are

insufficient data to claim transmission of CWD into humans; adding that

[only] by asking [the questions of venison consumption and deer/elk

hunting] in every case can we collect suspect cases and look into the

plausibility of transmission further. Samii argues that by making both

doctors and hunters more aware of the possibility of prions spreading

through eating venison, doctors treating hunters with dementia can

consider a possible prion disease, and doctors treating CJD patients

will know to ask whether they ate venison.


CDC spokesman Ermias Belay says that the CDC will not be investigating

the [Samii] cases because there is no evidence that the men ate

CWD-infected meat. He notes that although the likelihood of CWD

jumping the species barrier to infect humans cannot be ruled out 100%

and that [we] cannot be 100% sure that CWD does not exist in humans&

the data seeking evidence of CWD transmission to humans have been very

limited.


http://infection.thelancet.com/journal/journal.isa


he complained in a letter to the Journal of the American Medical

Association (JAMA 2003; 285: 733). I hope that the CDC does not

continue to expect us to still believe that the 85% plus of all CJD

cases which are sporadic are all spontaneous, without route or source.<<<

actually, that quote was from a more recent article in the Journal of

Neurology (see below), not the JAMA article...

Full Text

Diagnosis and Reporting of Creutzfeldt-Jakob Disease

Singeltary, Sr et al. JAMA.2001; 285: 733-734.

http://jama.ama-assn.org/cgi/content/full/285/6/733?maxtoshow=&HITS=10&hits=10&RESULTFORMAT=&fulltext=dignosing+and+reporting+creutzfeldt+jakob+disease&searchid=1048865596978_1528&stored_search=&FIRSTINDEX=0&journalcode=jama

BRITISH MEDICAL JOURNAL

SOMETHING TO CHEW ON

BMJ

http://www.bmj.com/cgi/eletters/319/7220/1312/b#EL2

BMJ

http://www.bmj.com/cgi/eletters/320/7226/8/b#EL1

THE PATHOLOGICAL PROTEIN

BY Philip Yam

Yam Philip Yam News Editor Scientific American www.sciam.com
http://www.thepathologicalprotein.com/

IN light of Asante/Collinge et al findings 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;

-------- Original Message -------- Subject: re-BSE prions propagate as

either variant CJD-like or sporadic CJD Date: Thu, 28 Nov 2002 10:23:43

-0000 From: "Asante, Emmanuel A" To:
"'flounder@wt.net'"

Dear Terry,

I have been asked by Professor Collinge to respond to your request. I am

a Senior Scientist in the MRC Prion Unit and the lead author on the

paper. I have attached a pdf copy of the paper for your attention. Thank

you for your interest in the paper.

In respect of your first question, the simple answer is, yes. As you

will find in the paper, we have managed to associate the alternate

phenotype to type 2 PrPSc, the commonest sporadic CJD.

It is too early to be able to claim any further sub-classification in

respect of Heidenhain variant CJD or Vicky Rimmer's version. It will

take further studies, which are on-going, to establish if there are

sub-types to our initial finding which we are now reporting. The main

point of the paper is that, as well as leading to the expected new

variant CJD phenotype, BSE transmission to the 129-methionine genotype

can lead to an alternate phenotype which is indistinguishable from type

2 PrPSc.

I hope reading the paper will enlighten you more on the subject. If I

can be of any further assistance please to not hesitate to ask. Best wishes.

Emmanuel Asante

<> ____________________________________

Dr. Emmanuel A Asante MRC Prion Unit & Neurogenetics Dept. Imperial

College School of Medicine (St. Mary's) Norfolk Place, LONDON W2 1PG

Tel: +44 (0)20 7594 3794 Fax: +44 (0)20 7706 3272 email:

e.asante@ic.ac.uk (until 9/12/02)

New e-mail: e.asante@prion.ucl.ac.uk (active from now)

____________________________________

snip...

full text ;

http://www.fda.gov/ohrms/dockets/ac/03/slides/3923s1_OPH.htm


CJD WATCH

http://www.fortunecity.com/healthclub/cpr/349/part1cjd.htm

CJD WATCH MESSAGE BOARD

http://disc.server.com/Indices/167318.html

TSS





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