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From: TSS ()
Subject: Docket No. FSIS-2006-0011E - Harvard Risk Assessment of Bovine Spongiform Encephalopathy (BSE) Update; Notice of Availability and Technical Meeting
Date: September 12, 2006 at 8:49 am PST

[Federal Register: September 12, 2006 (Volume 71, Number 176)]
[Notices]
[Page 53649-53650]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr12se06-33]

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

DEPARTMENT OF AGRICULTURE

Food Safety and Inspection Service

[Docket No. FSIS-2006-0011E]


Harvard Risk Assessment of Bovine Spongiform Encephalopathy (BSE)
Update; Notice of Availability and Technical Meeting

AGENCY: Food Safety and Inspection Service, USDA.

ACTION: Notice of availability; reopening and extension of comment
period.

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

SUMMARY: The Food Safety and Inspection Service (FSIS) is reopening and
extending the comment period for the 2005 updated Harvard Risk
Assessment of bovine spongiform encephalopathy (BSE). The original
comment period closed on August 11, 2006. The Agency is taking this
action in response to a comment that was submitted after the Agency
held its July 25, 2006, technical meeting to provide information on the
updated risk assessment model and report.

DATES: Comments are due by October 27, 2006.


snip...

http://www.fsis.usda.gov/Frame/FrameRedirect.asp?main=http://www.fsis.usda.gov/OPPDE/rdad/FRPubs/2006-0011E.htm

Greetings FSIS,

I must comment please, on ;

Docket No. FSIS-2006-0011E - Harvard Risk Assessment of Bovine Spongiform Encephalopathy (BSE) Update; Notice of Availability and Technical Meeting


I hope that you don't need more time to let industry reps try and water this thing down as much as possible (just my opinion). HOWEVER, if you just look at was was promised to us on SRMs before, and then the after product, only then will you see just how industry friendly these regulations are. let's first take a look at
what was first promised ;


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


YEP, were still waiting. WHILE were still waiting, the agent is still amplifying and spreading through these...... how are they called ;

Expanded "Mad Cow" Safeguards Announced
to Strengthen Existing Firewalls Against BSE Transmission

or

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.


LET US LOOK at these 'expanded, existing, firewalls, and just HOW MUCH POTENTIAL MAD COW FEED they are speaking of IN COMMERCE IN 2006 ALONE. for those that think i exploit these as.... how was it put to me recently on me posting these recalls as only a 'potential hazard' and that the feed in question was not obvious from 'BSE covert animals' and that would only be true IF there were a BSE surveillance system in the USA that was set up to FIND BSE cases. I think it has well been astablished that this is not the case. IN fact Paul Brown said about the enfamous June 2004 Enhanced BSE cover-up ;

CDC DR. PAUL BROWN TSE EXPERT COMMENTS 2006

The U.S. Department of Agriculture was quick to assure the public earlier this week that the third case of mad cow disease did not pose a risk to them, but what federal officials have not acknowledged is that this latest case indicates the deadly disease has been circulating in U.S. herds for at least a decade.

The second case, which was detected last year in a Texas cow and which USDA officials were reluctant to verify, was approximately 12 years old.

These two cases (the latest was detected in an Alabama cow) present a picture of the disease having been here for 10 years or so, since it is thought that cows usually contract the disease from contaminated feed they consume as calves. The concern is that humans can contract a fatal, incurable, brain-wasting illness from consuming beef products contaminated with the mad cow pathogen.

"The fact the Texas cow showed up fairly clearly implied the existence of other undetected cases," Dr. Paul Brown, former medical director of the National Institutes of Health's Laboratory for Central Nervous System Studies and an expert on mad cow-like diseases, told United Press International. "The question was, 'How many?' and we still can't answer that."

Brown, who is preparing a scientific paper based on the latest two mad cow cases to estimate the maximum number of infected cows that occurred in the United States, said he has "absolutely no confidence in USDA tests before one year ago" because of the agency's reluctance to retest the Texas cow that initially tested positive.

USDA officials finally retested the cow and confirmed it was infected seven months later, but only at the insistence of the agency's inspector general.

"Everything they did on the Texas cow makes everything USDA did before 2005 suspect," Brown said. ...snip...end


http://www.upi.com/ConsumerHealthDaily/view.php?StoryID=20060315-055557-1284r


AND NOT TO FORGET what the OIG has said time and time again over the years;


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


03-025IF 03-025IF-631 Linda A. Detwiler [PDF]

http://www.fsis.usda.gov/OPPDE/Comments/03-025IF/03-025IF-631.pdf

Specified Risk Materials (SRMs)

I am in full support of the interim final rule which prohibits SRMs from

being included in food for human consumption. In addition to the list of

tissues published in this rule, I am requesting that additional tissues be

added to the list. These would include dura

("sheath") covering the spinal cord and the ENTIRE INTESTINE (from pylorus

to rectum). The scientific justification is provided below. THESE SRMs

should also be prohibited from ANY FDA regulated food or product intended

for human consumption, including but not limited to flavorings, extracts,

etc. ...

Dr. Linda Detwiler comments in full;

http://www.fsis.usda.gov/OPPDE/Comments/03-025IF/03-025IF-634.pdf


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

http://www.fda.gov/ohrms/dockets/dockets/02n0273/02n-0273-c000534-01-vol45.pdf

http://www.fda.gov/ohrms/dockets/dockets/02n0273/02n-0273-c000490-vol40.pdf

THE SEVEN 1/2 SCIENTIST REPORT *** ;-)

http://www.fda.gov/ohrms/dockets/dockets/02n0273/02n-0273-EC244-Attach-1.pdf

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

http://www.fda.gov/ohrms/dockets/dockets/02n0273/02n-0273-c000383-01-vol35.pdf

SO, let me exploit these FACTS again. I mean these feeders are still laughing all the way to the bank, while spreading the mad cow agent to hell and back in the USA ;


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

PRODUCT
a) EVSRC Custom dairy feed, Recall # V-130-6;
b) Performance Chick Starter, Recall # V-131-6;
c) Performance Quail Grower, Recall # V-132-6;
d) Performance Pheasant Finisher, Recall # V-133-6.
CODE
None
RECALLING FIRM/MANUFACTURER
Donaldson & Hasenbein/dba J&R Feed Service, Inc., Cullman, AL, by telephone
on June 23, 2006 and by letter dated July 19, 2006. Firm initiated recall is
complete.
REASON
Dairy and poultry feeds were possibly contaminated with ruminant based
protein.
VOLUME OF PRODUCT IN COMMERCE
477.72 tons
DISTRIBUTION
AL
______________________________
PRODUCT
a) Dairy feed, custom, Recall # V-134-6;
b) Custom Dairy Feed with Monensin, Recall # V-135-6.
CODE
None. Bulk product
RECALLING FIRM/MANUFACTURER
Recalling Firm: Burkmann Feed, Greeneville, TN, by Telephone beginning on
June 28, 2006.
Manufacturer: H. J. Baker & Bro., Inc., Albertville, AL. Firm initiated
recall is complete.
REASON
Possible contamination of dairy feeds with ruminant derived meat and bone
meal.
VOLUME OF PRODUCT IN COMMERCE
1,484 tons
DISTRIBUTION
TN and WV


http://www.fda.gov/bbs/topics/enforce/2006/ENF00968.html

Subject: MAD COW FEED RECALLS ENFORCEMENT REPORT FOR AUGUST 9, 2006 KY, LA,
MS, AL, GA, AND TN 11,000+ TONS
Date: August 16, 2006 at 9:19 am PST

RECALLS AND FIELD CORRECTIONS: VETERINARY MEDICINE - CLASS II
______________________________
PRODUCT
Bulk custom made dairy feed, Recall # V-115-6
CODE
None
RECALLING FIRM/MANUFACTURER
Hiseville Feed & Seed Co., Hiseville, KY, by telephone and letter on or
about July 14, 2006. FDA initiated recall is ongoing.
REASON
Custom made feeds contain ingredient called Pro-Lak which may contain
ruminant derived meat and bone meal.
VOLUME OF PRODUCT IN COMMERCE
Approximately 2,223 tons
DISTRIBUTION
KY

______________________________
PRODUCT
Bulk custom made dairy feed, Recall # V-116-6
CODE
None
RECALLING FIRM/MANUFACTURER
Rips Farm Center, Tollesboro, KY, by telephone and letter on July 14, 2006.
FDA initiated recall is ongoing.
REASON
Custom made feeds contain ingredient called Pro-Lak which may contain
ruminant derived meat and bone meal.
VOLUME OF PRODUCT IN COMMERCE
1,220 tons
DISTRIBUTION
KY

______________________________
PRODUCT
Bulk custom made dairy feed, Recall # V-117-6
CODE
None
RECALLING FIRM/MANUFACTURER
Kentwood Co-op, Kentwood, LA, by telephone on June 27, 2006. FDA initiated
recall is completed.
REASON
Possible contamination of animal feed ingredients, including ingredients
that are used in feed for dairy animals, with ruminant derived meat and bone
meal.
VOLUME OF PRODUCT IN COMMERCE
40 tons
DISTRIBUTION
LA and MS

______________________________
PRODUCT
Bulk Dairy Feed, Recall V-118-6
CODE
None
RECALLING FIRM/MANUFACTURER
Cal Maine Foods, Inc., Edwards, MS, by telephone on June 26, 2006. FDA
initiated recall is complete.
REASON
Possible contamination of animal feed ingredients, including ingredients
that are used in feed for dairy animals, with ruminant derived meat and bone
meal.
VOLUME OF PRODUCT IN COMMERCE
7,150 tons
DISTRIBUTION
MS

______________________________
PRODUCT
Bulk custom dairy pre-mixes, Recall # V-119-6
CODE
None
RECALLING FIRM/MANUFACTURER
Walthall County Co-op, Tylertown, MS, by telephone on June 26, 2006. Firm
initiated recall is complete.
REASON
Possible contamination of dairy animal feeds with ruminant derived meat and
bone meal.
VOLUME OF PRODUCT IN COMMERCE
87 tons
DISTRIBUTION
MS

______________________________
PRODUCT
Bulk custom dairy pre-mixes, Recall # V-120-6
CODE
None
RECALLING FIRM/MANUFACTURER
Ware Milling Inc., Houston, MS, by telephone on June 23, 2006. Firm
initiated recall is complete.
REASON
Possible contamination of dairy animal feeds with ruminant derived meat and
bone meal.
VOLUME OF PRODUCT IN COMMERCE
350 tons
DISTRIBUTION
AL and MS

______________________________
PRODUCT
a) Tucker Milling, LLC Tm 32% Sinking Fish Grower, #2680-Pellet,
50 lb. bags, Recall # V-121-6;
b) Tucker Milling, LLC #31120, Game Bird Breeder Pellet,
50 lb. bags, Recall # V-122-6;
c) Tucker Milling, LLC #31232 Game Bird Grower,
50 lb. bags, Recall # V-123-6;
d) Tucker Milling, LLC 31227-Crumble, Game Bird Starter, BMD
Medicated, 50 lb bags, Recall # V-124-6;
e) Tucker Milling, LLC #31120, Game Bird Breeder, 50 lb bags,
Recall # V-125-6;
f) Tucker Milling, LLC #30230, 30 % Turkey Starter, 50 lb bags,
Recall # V-126-6;
g) Tucker Milling, LLC #30116, TM Broiler Finisher,
50 lb bags, Recall # V-127-6
CODE
All products manufactured from 02/01/2005 until 06/20/2006
RECALLING FIRM/MANUFACTURER
Recalling Firm: Tucker Milling LLC, Guntersville, AL, by telephone and visit
on June 20, 2006, and by letter on June 23, 2006.
Manufacturer: H. J. Baker and Brothers Inc., Stamford, CT. Firm initiated
recall is ongoing.
REASON
Poultry and fish feeds which were possibly contaminated with ruminant based
protein were not labeled as "Do not feed to ruminants".
VOLUME OF PRODUCT IN COMMERCE
7,541-50 lb bags
DISTRIBUTION
AL, GA, MS, and TN

END OF ENFORCEMENT REPORT FOR AUGUST 9, 2006

###


http://www.fda.gov/bbs/topics/ENFORCE/2006/ENF00964.html


Subject: MAD COW FEED RECALL MI MAMMALIAN PROTEIN VOLUME OF PRODUCT IN
COMMERCE 27,694,240 lbs
Date: August 6, 2006 at 6:14 pm PST
PRODUCT
Bulk custom dairy feds manufactured from concentrates, Recall # V-113-6
CODE
All dairy feeds produced between 2/1/05 and 6/16/06 and containing H. J.
Baker recalled feed products.
RECALLING FIRM/MANUFACTURER
Vita Plus Corp., Gagetown, MI, by visit beginning on June 21, 2006. Firm
initiated recall is complete.
REASON
The feed was manufactured from materials that may have been contaminated
with mammalian protein.
VOLUME OF PRODUCT IN COMMERCE
27,694,240 lbs
DISTRIBUTION
MI


END OF ENFORCEMENT REPORT FOR AUGUST 2, 2006

###


http://www.fda.gov/bbs/topics/enforce/2006/ENF00963.html


Subject: MAD COW FEED RECALL AL AND FL VOLUME OF PRODUCT IN COMMERCE 125
TONS Products manufactured from 02/01/2005 until 06/06/2006
Date: August 6, 2006 at 6:16 pm PST
PRODUCT
a) CO-OP 32% Sinking Catfish, Recall # V-100-6;
b) Performance Sheep Pell W/Decox/A/N, medicated,
net wt. 50 lbs, Recall # V-101-6;
c) Pro 40% Swine Conc Meal -- 50 lb, Recall # V-102-6;
d) CO-OP 32% Sinking Catfish Food Medicated,
Recall # V-103-6;
e) "Big Jim's" BBB Deer Ration, Big Buck Blend,
Recall # V-104-6;
f) CO-OP 40% Hog Supplement Medicated Pelleted,
Tylosin 100 grams/ton, 50 lb. bag, Recall # V-105-6;
g) Pig Starter Pell II, 18% W/MCDX Medicated 282020,
Carbadox -- 0.0055%, Recall # V-106-6;
h) CO-OP STARTER-GROWER CRUMBLES, Complete
Feed for Chickens from Hatch to 20 Weeks, Medicated,
Bacitracin Methylene Disalicylate, 25 and 50 Lbs,
Recall # V-107-6;
i) CO-OP LAYING PELLETS, Complete Feed for Laying
Chickens, Recall # 108-6;
j) CO-OP LAYING CRUMBLES, Recall # V-109-6;
k) CO-OP QUAIL FLIGHT CONDITIONER MEDICATED,
net wt 50 Lbs, Recall # V-110-6;
l) CO-OP QUAIL STARTER MEDICATED, Net Wt. 50 Lbs,
Recall # V-111-6;
m) CO-OP QUAIL GROWER MEDICATED, 50 Lbs,
Recall # V-112-6
CODE
Product manufactured from 02/01/2005 until 06/06/2006
RECALLING FIRM/MANUFACTURER
Alabama Farmers Cooperative, Inc., Decatur, AL, by telephone, fax, email and
visit on June 9, 2006. FDA initiated recall is complete.
REASON
Animal and fish feeds which were possibly contaminated with ruminant based
protein not labeled as "Do not feed to ruminants".
VOLUME OF PRODUCT IN COMMERCE
125 tons
DISTRIBUTION
AL and FL


END OF ENFORCEMENT REPORT FOR AUGUST 2, 2006

###


http://www.fda.gov/bbs/topics/enforce/2006/ENF00963.html


Subject: MAD COW FEED RECALL KY VOLUME OF PRODUCT IN COMMERCE ?????
Date: August 6, 2006 at 6:19 pm PST
PRODUCT
Bulk custom made dairy feed, Recall # V-114-6
CODE
None
RECALLING FIRM/MANUFACTURER
Burkmann Feeds LLC, Glasgow, KY, by letter on July 14, 2006. Firm initiated
recall is ongoing.
REASON
Custom made feeds contain ingredient called Pro-Lak, which may contain
ruminant derived meat and bone meal.
VOLUME OF PRODUCT IN COMMERCE
?????
DISTRIBUTION
KY
END OF ENFORCEMENT REPORT FOR AUGUST 2, 2006

###


http://www.fda.gov/bbs/topics/enforce/2006/ENF00963.html


CJD WATCH MESSAGE BOARD
TSS
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


Subject: MAD COW FEED BAN WARNING LETTER ISSUED MAY 17, 2006
Date: June 27, 2006 at 7:42 am PST
Public Health Service
Food and Drug Administration

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

[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

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

Docket Management Docket: 02N-0273 - Substances Prohibited From Use in

Animal Food or Feed; Animal Proteins Prohibited in Ruminant Feed

Comment Number: EC -10

Accepted - Volume 2


http://www.fda.gov/ohrms/dockets/dailys/03/Jan03/012403/8004be07.html

PART 2


http://www.fda.gov/ohrms/dockets/dailys/03/Jan03/012403/8004be09.html


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 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


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



EFSA Scientific Report on the Assessment of the Geographical BSE-Risk (GBR) of Canada

Adopted July 2004 (Question N° EFSA-Q-2003-083)


[Last updated 08 September 2004]
[Publication Date 20 August 2004]


http://www.efsa.europa.eu/en/science/tse_assessments/gbr_assessments/564.html


EFSA Scientific Report on the Assessment of the Geographical BSE-Risk (GBR) of Mexico

Adopted July 2004 (Question N° EFSA-Q-2003-083)


[Last updated 08 September 2004]
[Publication Date 20 August 2004]


http://www.efsa.europa.eu/en/science/tse_assessments/gbr_assessments/565.html


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

Adopted July 2004 (Question N° EFSA-Q-2003-083)


[Last updated 08 September 2004]
[Publication Date 20 August 2004]


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


I THINK that the FSIS, USDA, APHIS, FDA, and everyone else envolved in this mess has had plenty of time to get this right, i mean just look at the feed ban violations alone in 2006, let alone all years preveously, since the partial and voluntary Aug. 4, 1997 ban was put into place. IN my opinion, these industry friendly regulations and the agencies that put them into place, or not, have all failed the public terribly. just how bad will only be known in the years and decades to come, for there failure has exposed us all to the mad cow agent, in more ways than one. the incubation period is the only saving grace. maybe we will all die from something else before clinical disease appears, maybe not. and even if the agent only appears to infect and kill only a few in the years and decades to come, it
will not make right, what every federal agency failed to do, and that is protect the consumer. ONLY by Gods grace and a mircale will this disease disappear anytime soon, and I pray that it does. However, it will not be from anything that any of these industry friendly agencies have done, because what they have done is fail from day one with BSE regulations, and they still fail today. YOUR only fooling yourself with the infamous Enhanced June 2004 BSE surveillance system. THOSE test and protocols for them were flawwed from day one, and everyone around the globe (except USDA/APHIS/FSIS) knows it. I call for a redo of that same program, only this time lets use the most sensitive testing, lets use proper protocol, and lets not cherry pick the cows that are to be tested, or not. you cannot render a stumbling and staggering suspect mad cow before any test at all, that's not fare either. no more suspect BSE samples sitting on the shelves for 4 to 7+ months, and it should not take an act of Congress to finally get them confirmed. FINALLY, THE BSE MRR POLICY MUST BE REPEALED, AND THE BSE GBR RISK ASSESSMENTS MUST BE ADHERED TO, and strengthened to include all TSE. anything less is not acceptable and will only amplify and spread the BSE/TSE agent. ...


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


----- Original Message -----
From: "Terry S. Singeltary Sr."
To:
Sent: Saturday, August 26, 2006 12:05 PM
Subject: [Docket No. FSIS-2006-0011] FSIS Harvard Risk Assessment of Bovine Spongiform Encephalopathy (BSE) {TSS}


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

Sent: Monday, July 24, 2006 1:09 PM

To: FSIS RegulationsComments

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

Page 1 of 98

8/3/2006

Greetings FSIS,

I would kindly like to comment on the following ;

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

Sent: Monday, July 24, 2006 1:09 PM

To: FSIS RegulationsComments

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

Page 1 of 98

8/3/2006

Greetings FSIS,

I would kindly like to comment on the following ;

[Federal Register: July 12, 2006 (Volume 71, Number 133)]

[Notices]

[Page 39282-39283]

From the Federal Register Online via GPO Access [wais.access.gpo.gov]

[DOCID:fr12jy06-35]

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

DEPARTMENT OF AGRICULTURE

Food Safety and Inspection Service

[Docket No. FSIS-2006-0011]

Harvard Risk Assessment of Bovine Spongiform Encephalopathy (BSE)

Update; Notice of Availability and Technical Meeting

AGENCY: Food Safety and Inspection Service, USDA.

ACTION: Notice of availability and announcement of technical meeting.

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

SUMMARY: The Food Safety and Inspection Service (FSIS) is announcing

the availability of an updated risk assessment model and report for

BSE. The previous risk assessment, released in October 2003, was

revised to incorporate information available through December 2003,

including the discovery of a BSE-infected cow in Washington State. The

revised risk assessment model evaluates the impact of measures

implemented after the discovery of the BSE-positive cow and

recommendations made by an international BSE panel. FSIS will also hold

a technical meeting to discuss the updated risk assessment model and

report.

DATES: The public meeting will be held on July 25, 2006, from 1 p.m. to

4 p.m. Comments on the updated Harvard Risk Assessment must be received

by August 11, 2006.

snip...END

http://a257.g.akamaitech.net/7/257/2422/01jan20061800/edocket.access.gpo.gov/2006/E6-10928.htm

MY comments/questions are as follows ;

1. SINCE the first Harvard BSE Risk Assessment was so flawed and fraught with error after the PEER REVIEW

assessment assessed this fact, how do you plan on stopping this from happening again, will there be another peer

review with top TSE Scientist, an impartial jury so-to-speak, to assess this new and updated Harvard BSE/TSE risk

assessment and will this assessment include the Atypical TSE and SRM issues ?

*** Suppressed peer review of Harvard study October 31, 2002 ***

http://www.fsis.usda.gov/oa/topics/BSE_Peer_Review.pdf

2. WITH A RECENT NATION WIDE MAD COW FEED BAN RECALL in the past few months that consisted of

some 10,878.06 TONS, then another Mad Cow feed ban warning letter in May, IT should seem prudent to ask why our

feed bans continue to fail in 2006, and continue to fail today ?

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.

Page 2 of 98

8/3/2006

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

Subject: MAD COW FEED BAN WARNING LETTER ISSUED MAY 17, 2006

Date: June 27, 2006 at 7:42 am PST

Public Health Service

Food and Drug Administration

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).

Page 3 of 98

8/3/2006

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

3. WHY still now only partial ruminant feed ban, with the fact that now we seem to have 3 cases of nvCJD to humans

i.e. humanbovineTSE that were responsible from blood, and the fact the last 2 mad cows documented in the USA were

that of an Atypical strain, would it not seem prudent to remove blood as well from ruminant feed ?

Page 4 of 98

8/3/2006

WOULD it not seem prudent to improve and expand the SRM list now? as per your own thinking ;

> 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.

FULL text ;

Research Project: Study of Atypical Bse

Location: Virus and Prion Diseases of Livestock

Project Number: 3625-32000-073-07

Project Type: Specific C/A

Start Date: Sep 15, 2004

End Date: Sep 14, 2007

Objective:

The objective of this cooperative research project with Dr. Maria Caramelli from the Italian BSE Reference Laboratory in Turin, Italy, is to

conduct comparative studies with the U.S. bovine spongiform encephalopathy (BSE) isolate and the atypical BSE isolates identified in Italy.

The studies will cover the following areas: 1. Evaluation of present diagnostics tools used in the U.S. for the detection of atypical BSE cases. 2.

Molecular comparison of the U.S. BSE isolate and other typical BSE isolates with atypical BSE cases. 3. Studies on transmissibility and tissue

distribution of atypical BSE isolates in cattle and other species.

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

Page 5 of 98

8/3/2006

HOWEVER, JAPAN has already shown infectivity in tissues other than CNS in there atypical TSE in cattle, so why should we wait,

and expose many to this agent needlessly, since the last two mad cows in the USA were also atypical TSE ?

PrPSc distribution of a natural case of bovine spongiform encephalopathy

Yoshifumi Iwamaru, Yuka Okubo, Tamako Ikeda, Hiroko Hayashi, Mori- kazu Imamura, Takashi Yokoyama and Morikazu Shinagawa

Priori Disease Research Center, National Institute of Animal Health, 3-1-5 Kannondai, Tsukuba 305-0856 Japan gan@affrc.go.jp

Abstract

Bovine spongiform encephalopathy (BSE) is a disease of cattle that causes progressive neurodegeneration of the central nervous system. Infectivity of BSE agent is

accompanied with an abnormal isoform of prion protein (PrPSc).

The specified risk materials (SRM) are tissues potentially carrying BSE infectivity. The following tissues are designated as SRM in Japan: the skull including the brain and

eyes but excluding the glossa and the masse- ter muscle, the vertebral column excluding the vertebrae of the tail, spinal cord, distal illeum. For a risk management step, the

use of SRM in both animal feed or human food has been prohibited. However, detailed PrPSc distribution remains obscure in BSE cattle and it has caused controversies

about definitions of SRM. Therefore we have examined PrPSc distribution in a BSE cattle by Western blotting to reassess definitions of SRM.

The 11th BSE case in Japan was detected in fallen stock surveillance. The carcass was stocked in the refrigerator. For the detection of PrPSc, 200 mg of tissue samples

were homogenized. Following collagenase treatment, samples were digested with proteinase K. After digestion, PrPSc was precipitated by sodium phosphotungstate (PTA).

The pellets were subjected to Western blotting using the standard procedure. Anti-prion protein monoclonal antibody (mAb) T2 conjugated horseradish peroxidase was used

for the detection of PrPSc.

PrPSc was detected in brain, spinal cord, dorsal root ganglia, trigeminal ganglia, sublingual ganglion, retina. In addition, PrPSc was also detected in the peripheral nerves

(sciatic nerve, tibial nerve, vagus nerve).

Our results suggest that the currently accepted definitions of SRM in BSE cattle may need to be reexamined.

T. Kitamoto (Ed.)PRIONSFood and Drug Safety================

ALSO from the International Symposium of Prion Diseases held in Sendai, October 31, to November 2, 2004;

Bovine spongiform encephalopathy (BSE) in Japan

snip...

"Furthermore, current studies into transmission of cases of BSE that are atypical or that develop in young cattle are expected to

amplify the BSE prion"

NO. Date conf. Farm Birth place and Date Age at diagnosis

1. 8. 2003.10.6. Fukushima Tochigi 2001.10.13. 23

2. 9. 2003.11.4. Hiroshima Hyogo 2002.1.13. 21

Test results

# 8b, 9c cows Elisa Positive, WB Positive, IHC negative, histopathology negative

b = atypical BSE case

c = case of BSE in a young animal

b,c, No PrPSc on IHC, and no spongiform change on histology

International Symposium of Prion Diseases held in Sendai, October 31, to November 2, 2004.

Page 6 of 98

8/3/2006

Tetsuyuki Kitamoto Professor and Chairman Department of Prion Research Tohoku University School of Medicine 2-1

SeiryoAoba-ku, Sendai 980-8575, JAPAN TEL +81-22-717-8147 FAX +81-22-717-8148 e-mail; kitamoto@mail.tains.tohoku.ac.jp

Symposium Secretariat Kyomi Sasaki TEL +81-22-717-8233 FAX +81-22-717-7656 e-mail: kvomi-sasaki@mail.tains.tohoku.ac.ip

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

Atypical Proteinase K-Resistant Prion Protein (PrPres) observed in an Apparently Healthy 23-Month-Old Holstein Steer

Jpn. J. Infect. Dis., 56, 221-222, 2003

Laboratory and Epidemiology Communications

Atypical Proteinase K-Resistant Prion Protein (PrPres) Observed in an Apparently Healthy 23-Month-Old Holstein Steer

Yoshio Yamakawa*, KenŐichi Hagiwara, Kyoko Nohtomi, Yuko Nakamura, Masahiro Nishizima ,Yoshimi Higuchi1, Yuko Sato1,

Tetsutaro Sata1 and the Expert Committee for BSE Diagnosis, Ministry of Health, Labour and Welfare of Japan2

Department of Biochemistry & Cell Biology and 1Department of Pathology, National Institute of Infectious Diseases, Tokyo 162-

8640 and 2Miistry of Health, Labour and Welfare, Tokyo 100-8916

Communicated by Tetsutaro Sata

(Accepted December 2, 2003)

*Corresponding author: Mailing address: Department of Biochemistry and Cell Biology, National Institute of Infectious Diseases,

Toyama 1-23-1, Shinjuku-ku, Tokyo 1628640, Japan. Tel: +81-3-5285-1111, Fax: +81-3-5285-1157, E-mail: yamakawa@nih.go.jp

Since October 18, 2001, 'bovine spongiform encephalopathy (BSE) examination for all cattle slaughtered at abattoirs in the

country' has been mandated in Japan by the Ministry of Health, Labour and Welfare (MHLW). 'Plateria' ELISA-kit (Bio-Rad

Laboratories, Hercules, Calif., USA) is routinely used at abattoirs for detecting proteinase K (PK)-resistant prion protein (PrPSc) in

the obex region. Samples positive according to the ELISA screening are further subjected to Western blot (WB) and histologic and

immunohistochemical examination (IHC) at the National Institute of Infectious Diseases (NIID) or Obihiro University. If PrPSc is

detected either by WB or by IHC, the cattle are diagnosed as BSE. The diagnosis is approved by the Expert Committee for BSE

Diagnosis, MHLW. From October 18, 2001 to September 30, 2003, approximately 2.5 million cattle were screened at abattoirs. A

hundred and ten specimens positive according to ELISA were subjected to WB/IHC. Seven showed positive by both WB and IHC,

all exhibiting the typical electrophoretic profile of a high content of the di-glycosylated molecular form of PrPSc (1-3) and the

distinctive granular deposition of PrPSc in neuronal cells and neuropil of the dorsal nucleus of vagus.

An ELISA-positive specimen from a 23 month-old Holstein steer slaughtered on September 29, 2003, in Ibaraki Prefecture (Ibaraki

case) was sent to the NIID for confirmation. The animal was reportedly healthy before slaughter. The OD titer in ELISA was

slightly higher than the 'cut-off' level given by the manufacturer. The histology showed no spongiform changes and IHC revealed

no signal of PrPSc accumulation typical for BSE. However, WB analysis of the homogenate that was prepared from the obex

region and used for ELISA revealed a small amount of PrPSc with an electrophoretic profile different from that of typical BSEassociated

PrPSc (1-3). The characteristics were (i) low content of the di-glycosylated molecular form of PrPSc, (ii) a faster

migration of the non-glycosylated form of PrPSc on SDS-PAGE, and (iii) less resistance against PK digestion as compared with

an authentic PrPSc specimen derived from an 83-month-old Holstein (Wakayama case) (Fig. 1). Table 1 summarizes the relative

amounts of three distinctive glycoforms (di-, mono, non-glycosylated) of PrPSc calculated by densitometric analysis of the blot

shown in Fig. 1. As 2.5 mg wet weight obex-equivalent homogenate of the Ibaraki case (Fig. 1, lane 4) gave slightly stronger band

intensities of PrPSc than an 8 mg wet weight obex-equivqlent homogenate of a typical BSE-affected Wakayama case (Fig. 1, lane

2), the amount of PrPSc accumulated in the Ibaraki case was calculated to be 1/500 - 1/1000 of the Wakayama case. In the

Ibaraki case, the PrPSc bands were not detectable in the homogenates of the proximal surrounding region of the obex. These

findings were consistent with the low OD value in ELISA, i.e., 0.2 -0.3 for the Ibaraki case versus over 3.0 for the Wakayama case.

The DNA sequence of the PrP coding region of the Ibaraki case was the same as that appearing in the database (GenBank

accession number: AJ298878). More recently, we encountered another case that resembled the Ibaraki case. It was a 21-

monthold Holstein steer from Hiroshima Prefecture. WB showed typical BSE-specific PrPSc deposition though IHC did not detect

positive signals of PrPSc (data not shown).

Page 7 of 98

8/3/2006

Though the clinical onset of BSE is usually at around 5 years of age or later, a 20-month-old case showing the clinical signs has

been reported (4). Variant forms of BSE similar to our cases, i.e., with atypical histopathological and/or biochemical phenotype,

have been recently reported in Italy (5) and in France (6). Such variant BSE was not associated with mutations in the prion protein

(PrP) coding region as in our case (5,6).

The Ministry of Agriculture, Forestry and Fisheries of Japan (MAFF) announced a ban of feeding ruminants with meat bone meal

(MBM) on September 18, 2001, and a complete ban was made on October 15 of the same year. According to the recent MAFF

report, the previous seven cases of BSE in Japan were cattle born in 1995 - 1996 and possibly fed with cross-contaminated feed.

However, the two cattle in this report were born after the complete ban. Whether contaminated MBM was implicated in the present

cases remains to be investigated.

REFERENCES

Collinge, J., Sidle, K. C. L., Meads, J., Ironside, J. and Hill, A. F. (1996): Molecular analysis of prion strain variation and the

aetiology of 'new variant' CJD. Nature, 383, 685

690. Bruce, M. E., Will, R. G., Ironside, J. W., McConnell, I., Drummond, D., Suttie, A., McCardle, L., Chree, A., Hope, J., Birkett,

C., Cousens, S., Fraser, H. and Bostock, C. J. (1997): Transmissions to mice indicate that 'new variant' CJD is caused by the BSE

agent. Nature, 389, 498-501. Hill, A. F., Desbruslais, M., Joiner, S., Sidle, K. C. L., Gowland, I. and Collinge, J. (1997): The same

prion strain causes vCJD and BSE. Nature, 389, 448-450. Matravers, W., Bridgeman, J. and Smith, M.-F. (ed.)(2000): The BSE

Inquiry. p. 37. vol. 16. The Stationery Office Ltd., Norwich, UK. Casalone, C., Zanusso, G., Acutis, P. L., Crescio, M. I., Corona,

C., Ferrari, S., Capobianco, R., Tagliavini, F., Monaco, S. and Caramelli, M. (2003): Identification of a novel molecular and

neuropathological BSE phenotype in Italy. International Conference on Prion Disease: from basic research to intervention

concepts. Gasreig, Munhen, October 8-10. Bicaba, A. G., Laplanche, J. L., Ryder, S. and Baron, T. (2003): A molecular variant of

bovine spongiform encephalopatie. International Conference on Prion Disease: from basic research to intervention concepts.

Gasreig, Munhen, October 8-10. Asante, E. A., Linehan, J. M., Desbruslais, M., Joiner, S., Gowland, I., Wood, A. L., Welch, J.,

Hill, A. F., Lloyd, S. E., Wadsworth, J. D. F. and Collinge, J. (2002). BSE prions propagate as either variant CJD-like or sporadic

CJD-like prion strains in transgenic mice expressing human prion protein. EMBO J., 21, 6358-6366.

9/13/2005

Page 12 of 17

SEE SLIDES IN PDF FILE;

http://www.nih.go.jp/JJID/56/221.pdf

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

4. WHAT does USDA/FDA ET AL intend to do about the risks of atypical BSE/TSE in cattle now that infectivity

shows in tissue samples other than CNS in Japan, the fact now that the last Texas mad cow and that last mad cow in

Alabama were indeed of the atypical strain, the fact that the studies long ago in Mission, Texas of USA sheep scrapie

transmission to the USA bovine, which proved an 'atypical tse' in the USA bovine, the fact also that USDA/FDA are

still floundering on the last SRM regulations, but with the BASE strain now in cattle that is not similar to nvCJD, but

very similar to the sporadic CJD, and sporadic CJD has tripled in the last few years in the USA. WHAT do you plan to

do to protect human health from these atypical strains of TSE, in relations to SRMs ?

5. THE 2004 Enhanced BSE surveillance program, that tested all those cows, but then we found just how terribly

flawed the program was, from testing protocols, to testing the most likely to have BSE i.e. high risk, to the

geographical distribution of the testing and high risk areas, to letting the tissue samples of one mad cow sit on a shelf

Page 8 of 98

8/3/2006

for 7+ months and then having to have an act of Congress to ever get that cow finally confirmed, to that other Texas

mad cow they decided to not even bother testing at all, just rendered that very suspect cow, to suspect to test evidently,

back to that Alabama mad cow that they could only give a guess as to age with dentition where we all know that the

age of that cow was so close to 10 years it could have been 9 years 7 months to 10 years 3 months, thus possibly being

an BAPB i.e. USA 'born after partial ban', to all those rabies suspect cows that did not have rabies, and DID NOT get

tested for BSE/TSE in that June 2004 enhanced surveillance program, even though the common lay person knows the

suspect rabies negative cows are suppose to be BSE/TSE tested, how does one correct all these blatant failures and will

they be corrected?

snip...

6. WHAT happened to the test results and MOUSE BIO-ASSAYS of those imported sheep from Belgium

confiscated and slaughtered from the Faillace's, what sort of TSE did these animals have ?

snip...

7. WHY is it that the Farm of the Mad Sheep of Mad River Valley were quarantined for 5 years, but none of these

farms from Texas and Alabama with Atypical TSE in the Bovine, they have not been quarantined for 5 years, why

not, with the real risk of BSE to sheep, whom is to say this was not BSE ?

snip...

8. Scrapie in sheep and goat, CWD in deer and elk, are both running rampant and have been for decades, you cannot

and have not controled it, what do you plan to do about that, anything different since everything else has failed so far ?

snip...

WITH ANIMAL TSE in the USA rampant (the USA is the most documented Nation in the world with the most species

with TSE, all of which have been rendered and fed back to animals for human and animal consumption for decades),

with atypical TSE now in the USA, when will you start testing all animals susceptible to a TSE ?

I find it deeply disturbing that now USDA et al in fact are cutting BSE/TSE testing in the USA bovine down to 40,000 a year for the

following reasons ;

BSE monitoring in bovine animals EU Jan 1 to June 6 2006 COMPARED to USA (how not to find BSE)

COMPARING APPLES TO ORANGES I.E. USA TESTING FIGURES FOR BSE TO CATTLE RATIO

before June 2004 Enhanced BSE surveillance, during June 2004 Enhanced BSE cover-up, and

Page 25 of 98

8/3/2006

AFTER, which was proposed this week to be around 40,000 annually from here on out, in a cattle

population for USA of about 100 million every year.

THEN COMPARE TO E.U. COUNTRIES TESTING FIGURES FOR BSE TO CATTLE RATIO.

PLEASE note besides the total tests *** country, I have added total cattle population along

with some additional information on some countries below. While you are analyzing the additional

information, check out some of the imports to USA from documented BSE countries and please note,

among other things, the infamous, non-species coding system for feed, mbm, and such.

Seems those USA BSE triple firewalls have been seeping all along.

AFTER analyzing for yourself, then ask yourself, who is fooling whom? ...TSS

snip...

SEE FAILURES ;

PLEASE NOTE, while your are analyzing this information, please note just how terribly flawed

the June 2004 Enhanced BSE surveillance program was in the USA, all those cattle tested are

meaningless. 1st off, the following does not make any sense to me and even at that, why so

many ?

It should be noted that since the enhanced surveillance program began, USDA has also conducted approximately 9,200

routine

IHC tests on samples that did not first undergo rapid testing. This was done to ensure that samples inappropriate for the

rapid screen

test were still tested, and also to monitor and improve upon IHC testing protocols. Of those 9,200 routine tests, one test

returned a

non-definitive result on July 27, 2005.

http://www.aphis.usda.gov/lpa/issues/bse_testing/test_results.html

CAN you imagine how many might have been positive, IF proper BSE testing protocols were used.

WE know the infamous IHC gold standard for BSE the USDA et al boast about so much, is not as

gold as they claim. COME to find out, it is the least likely to find BSE, and maybe that is why it was

so gold to the USDA. IT also reminds me of the other infamous 'gold standard' the USDA preach about

all the time ;

*** Suppressed peer review of Harvard study October 31, 2002 ***

http://www.fsis.usda.gov/oa/topics/BSE_Peer_Review.pdf

WE found out just how inept the program was from the TEXAS mad cow that

USDA et al tried to cover-up, but got caught by the Honorable Phyllis Fong of the OIG.

SEE FAILURES ;

Page 72 of 98

8/3/2006

snip...

TO REDUCE TESTING OF BSE IN THE USA TO ONLY 40,000 A YEAR, is simply not scientific regardless of

what the OIE BSE testing protocol calls for. ALL one has

to do is look at the countries above that all went down with BSE, that all went by the infamous OIE BSE testing

protocols. THEN and only then, after the USA finally fumbled the 'BSE FREE' golden egg and accidently had to

document a case or two of mad cow, low and behold, what next? yep, you guessed it, time to move the goal post in the

middle of the football game, GWs and his sleeping partners at the OIE, gave birth to the BSE MRR policy, the legal

trading of all strains of TSE globally was born. ...

BILLING CODE: 3410-34-P

DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

9 CFR Parts 93, 94, 95, and 96

[Docket No. 03-080-3]

RIN 0579-AB73

Bovine Spongiform Encephalopathy; Minimal-Risk Regions and Importation of Commodities

AGENCY: Animal and Plant Health Inspection Service, USDA.

ACTION: Final rule.

snip...full text 98 pages ;

http://www.fsis.usda.gov/OPPDE/Comments/2006-0011/2006-0011-1.pdf


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



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