Docket No. FSIS-2006-0011E - Harvard Risk Assessment of BSE

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----- 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/FrameRed ... -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/ ... 5557-1284r


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 ... IF-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 ... IF-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/docket ... -vol45.pdf

http://www.fda.gov/ohrms/dockets/docket ... -vol40.pdf

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

http://www.fda.gov/ohrms/dockets/docket ... tach-1.pdf

https://web01.aphis.usda.gov/regpublic. ... enDocument

http://www.fda.gov/ohrms/dockets/docket ... -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/2 ... 00968.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/2 ... 00964.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/2 ... 00963.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/2 ... 00963.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/2 ... 00963.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/2 ... 00960.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 ... 5IFA-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 ... 4be07.html

PART 2


http://www.fda.gov/ohrms/dockets/dailys ... 4be09.html


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


https://web01.aphis.usda.gov/BSEcom.nsf ... AutoFramed


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

https://web01.aphis.usda.gov/regpublic. ... enDocument


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/ts ... s/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/ts ... s/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/ts ... s/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,

snip...

snip...full text 98 pages ;

http://www.fsis.usda.gov/OPPDE/Comments ... 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 8:34 PM
Subject: Re: Docket No. FSIS-2006-0011E - Harvard Risk Assessment of Bovine Spongiform Encephalopathy (BSE) Update; Notice of Availability and Technical Meeting


##################### Bovine Spongiform Encephalopathy #####################

>>>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 ; <<<


no i dont' have a crystal ball, the facts speak for themselves, and yes,
they are laughing all the way to the bank, as i said. ...TSS


US Feed Ban May Be Too Costly To Industry
Today 9/12/2006 7:36:00 PM

US Feed Ban May Be Too Costly To Industry




WASHINGTON (Dow Jones)--The U.S. Food and Drug Administration may have
underestimated the cost to industry of the government's plan to improve the
way mad-cow disease contamination is kept out of livestock feed, Steve
Sundlof, director of the FDA Center for Veterinary Medicine, said Tuesday.


Sundlof, in an interview with Dow Jones Newswires, said FDA is now going
back over its proposal that seeks to force renderers to remove the brain and
spinal cord from all deadstock cattle processed for livestock feed.


The FDA had presumed that the rendering industry would not be hindered
greatly when the new feed rule proposal was devised, Sundlof said.


"What we heard back, was that no, that's probably not the case," Sundlof
said. Instead, only a minority of companies "would be willing to separate
the brain and spinal cord out."


Officials have been taken aback by the industry's response.


The FDA is reviewing previous assumptions and new data from representatives
of an industry that provides billions of pounds of protein for the livestock
feed industry. The delay, he said, may push publication of the final rule
back to "later this year," or beyond that.


The FDA unveiled its proposal to reform the U.S. feedban rule - set in 1997
to try to keep mad-cow disease from spreading in herds if it ever appeared
in the U.S. - about a year ago and gave the public 75 days to submit
comments.


Many of the 850 responses FDA received said the agency's plan would have a
stronger detrimental impact than the government anticipated.


"A lot of comments said that we underestimated considerably the economic
impact associated with what we proposed," Sundlof said.


Tom Cook, president of the National Renderers Association, said FDA's
proposal would "take the incentive away for rendering of a significant
portion of material that needs to be rendered."


He is talking about cattle that die on the farm and are carted off by
renderers. Many, he said, would stop collecting the carcasses if FDA's
current proposal is implemented.


"Animals that are picked up on the farm represent 2-4 billion pounds of raw
material a year," Cook said. "If the renderers can't afford to pick it up
... they're not going to do it anymore."


The FDA banned the practice of feeding bovine material to cattle in 1997
because mad-cow disease, or bovine spongiform encephalopathy, is believed to
be spread among cattle if they ingest infected material. Other livestock,
though, could continue to be fed all bovine material, including what is
considered risky material for BSE infection.


The first BSE-infected cow was found in the U.S. in December 2003. Since
then, two more cases in cows have been discovered.


In October 2005, FDA unveiled a plan to require that brains and spinal cords
be removed from all deadstock cattle before they are rendered for feed for
any animals. The FDA said that simply trying to keep bovine material out of
cattle feed was not good enough.


"Cross-contamination" of feed for cattle and feed for other livestock that
contained bovine material is a risk that should be avoided, FDA reasoned in
its proposal.


The FDA said "it may not be possible to verify that there is zero carryover
of feed or feed ingredients in equipment."


That proposal, though, may be so costly that it would remove a cheap protein
source from feed manufacturers who rely on rendering cattle carcasses that
aren't fit for human consumption.


"Many renderers believe this restriction on dead stock will be the beginning
of untenable economic pressure on dead stock collection that could
eventually lead to the end of the service for all species," the National
Renderers

Association said in a written submission to FDA.


FDA officials continue to review the economics of the proposed changes to
the U.S. feedban, Sundlof said. "So, we expect it will be some time before
we issue a final rule."


Source: Bill Tomson; Dow Jones Newswires; 202-646-0088;
[email protected]


http://www.cattlenetwork.com/content.as ... ntid=67844


STRICTLY PRIVATE AND CONFIDENTIAL 25, AUGUST 1995

snip...

To minimise the risk of farmers' claims for compensation from feed
compounders.

To minimise the potential damage to compound feed markets through adverse
publicity.

To maximise freedom of action for feed compounders, notably by
maintaining the availability of meat and bone meal as a raw
material in animal feeds, and ensuring time is available to make any
changes which may be required.

snip...

THE FUTURE

4..........

MAFF remains under pressure in Brussels and is not skilled at
handling potentially explosive issues.

5. Tests _may_ show that ruminant feeds have been sold which
contain illegal traces of ruminant protein. More likely, a few positive
test results will turn up but proof that a particular feed mill knowingly
supplied it to a particular farm will be difficult if not impossible.

6. The threat remains real and it will be some years before feed
compounders are free of it. The longer we can avoid any direct
linkage between feed milling _practices_ and actual BSE cases,
the more likely it is that serious damage can be avoided. ...

SEE full text ;

http://www.bseinquiry.gov.uk/files/yb/1 ... 002001.pdf


TSS





----- Original Message -----
From: "Terry S. Singeltary Sr." <[email protected]>
To: <[email protected]>
Sent: Tuesday, September 12, 2006 10:58 AM
Subject: Docket No. FSIS-2006-0011E - Harvard Risk Assessment of Bovine
Spongiform Encephalopathy (BSE) Update; Notice of Availability and Technical
Meeting


##################### 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

snip...end
 

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