##################### Bovine Spongiform Encephalopathy #####################
----- Original Message -----
From: "Terry S. Singeltary Sr." <[email protected]>
To: <[email protected]>
Sent: Tuesday, September 12, 2006 10:54 AM
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. [[email protected]]
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. [[email protected]]
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 [email protected]
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; [email protected]
Symposium Secretariat Kyomi Sasaki TEL +81-22-717-8233 FAX +81-22-717-7656
e-mail: [email protected]
=================================
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*, KenÕichi 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: [email protected]
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 ;
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
#################### https://lists.aegee.org/bse-l.html ####################
----- Original Message -----
From: "Terry S. Singeltary Sr." <[email protected]>
To: <[email protected]>
Sent: Tuesday, September 12, 2006 10:54 AM
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. [[email protected]]
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. [[email protected]]
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 [email protected]
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; [email protected]
Symposium Secretariat Kyomi Sasaki TEL +81-22-717-8233 FAX +81-22-717-7656
e-mail: [email protected]
=================================
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*, KenÕichi 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: [email protected]
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 ;
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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