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From: TSS ()
Subject: Milk Replacers and Bovine Spongiform Encephalopathy in Calves, Japan
Date: February 27, 2008 at 7:14 pm PST

Volume 14, Number 3–March 2008


Milk Replacers and Bovine Spongiform Encephalopathy in Calves, Japan

Toshiyuki Tsutsui,* Takehisa Yamamoto,* Sayaka Hashimoto,† Takashi Nonaka,*
Akiko Nishiguchi,*and Sota Kobayashi*
*National Institute of Animal Health, Ibaraki, Japan; and †Headquarters,
Fertilizer and Feed Inspection Services, Saitama, Japan

Suggested citation for this article

To the Editor: Milk replacers produced from a specific feed factory in Japan
were suspected of being associated with a cluster of bovine spongiform
encephalopathy (BSE) infection in calves. We conducted a case–control study
to test this association.


Figure. Number of cases of bovine spongiform encephalopathy by calves' birth
year, Japan.

In Japan, BSE infection has been confirmed in 32 calves as of the end of May
2007; 13 of these calves were born between December 1995 and August 1996.
One BSE-infected calf was born in 1992 and had an atypical BSE phenotype
(1). Because no BSE-infected calves were born in 1997 and 1998, we
considered that those born in 1995 and 1996 formed an independent temporal
cluster (Figure). Epidemiologic investigation showed that all 13 calves were
fed milk replacers produced by a specific factory. Ten calves were born in
Hokkaido, and 3 were born in the Kanto region, which is ˜800 km away from

In the case–control study, all farms where the 13 BSE-infected calves were
born and raised for at least 1 year were defined as case farms. Control
farms were defined as dairy farms where no BSE calves had been reported.
Candidates for control farms comprised 200 randomly selected farms, which
were located in 23 prefectures where the milk replacers were distributed. We
used a national cattle identification database for random selection.
Veterinary officers from the local government interviewed farmers in
November and December 2006 and requested that they complete a questionnaire
on farming practices in 1996, including herd size and use of milk replacers
and calf concentrates. For the case farms, information previously obtained
from outbreaks was used. Of the 200 potential control farms, 154 farms were
used as controls. Forty-six farms were excluded; 24 farmers did not respond
or could not specify the use of milk replacers; and 22 farms had either
closed or farmers did not respond for miscellaneous reasons.

Among the 154 control farms, 36 farms (23%) used the milk replacers from the
specific factory, 89 farms (58%) used other milk replacers, and 29 farms
(19%) did not use milk replacers. Since 1 case farm lacked documented
evidence about the use of the specific milk replacers, we conservatively
assumed that 12 of 13 case farms used the specific milk replacers. We
estimated the odds ratio for this risk factor by using logistic regression
analysis. Our results indicated that the use of the milk replacers produced
by the specific factory was associated with BSE infection (odds ratio [OR]
39.3, 95% confidence interval [CI] 4.9–312.9, p = 0.0005).

The milk replacers produced by the specific factory contained tallow that
was produced at domestic rendering factories and imported from the
Netherlands. Milk replacers were fed to calves during a relatively short
period after birth (an average of 79 and 68 days, for case and control
farms, respectively). If 1 production lot of milk replacer became
accidentally contaminated with BSE, the exposure would occur in newborn
calves within a relatively short period. This contamination may explain why
11 of 13 BSE-infected calves were born within a 2-month period from February
10, 1996, to April 8, 1996.

In Hokkaido, 9 of 10 BSE-infected calves were fed calf concentrates produced
in the same feed factory. This proportion was higher than that of the 50
control farms in Hokkaido (22/50, Fisher exact test, p = 0.013). The calf
concentrates might have become contaminated with meat-and-bone meal (MBM)
because this factory used MBM for other animal feed. Multivariate logistic
regression analysis, including this factor and that for the specific milk
replacers, did not indicate significant association between the specific
calf concentrates and occurrence of BSE (calf concentrates: OR 3.2 [CI
0.8–13.0], p = 0.14; milk replacers: OR 21.7 [CI 2.5–192.6], p = 0.006). The
factory that provided the specific concentrates belonged to a company
affiliated with the company that produced the milk replacers in question.
Given the fact that farmers tend to use milk replacers and calf concentrates
from the same company, association of the calf concentrates with the BSE
infection may have been masked by the use of specific milk replacers.
However, our study is limited by the small number of BSE cases and
investigation of events that occurred 10 years ago.

A possible causal association between the feeding of potentially
contaminated milk replacers to calves and the occurrence of BSE has been
suggested by several epidemiologic studies (2–5). However, no report shows
experimental transmission of BSE by use of tallow or milk replacers (6).
This lack of evidence in the literature may suggest that the risk of
contracting BSE from processed tallow or milk replacers is low (7). If MBM
is excluded as a source of infection, other transmission mechanisms, such as
the feeding of animal fat, may become more important.

This research was conducted under a research project for using advanced
technologies in agriculture, forestry, and fisheries.


Hagiwara K, Yamakawa Y, Sato Y, Nakamura Y, Tobiume M, Shinagawa M, et al.
Accumulation of mono-glycosylated form-rich, plaque-forming PrPsc in the
second atypical bovine spongiform encephalopathy case in Japan. Jpn J Infect
Dis. 2007;60:305–8.
Paisley LG, Hostrup-Pedersen J. A quantitative assessment of the risk of
transmission of bovine spongiform encephalopathy by tallow-based calf
milk-replacer. Prev Vet Med. 2004;63:135–49.
Clauss M, Sauter-Louis C, Chaher E, Pottgiesser S, Goebel S, Selhorst T, et
al. Investigation of the potential risk factors associated with cases of
bovine spongiform encephalopathy in Bavaria, Germany. Vet Rec.
Jarrige N, Ducrot C, Cazeau G, Morignat E, La Bonnardiere C, Calavas D.
Case–control study on feed risk factors for BSE cases born after the feed
ban in France. Vet Res. 2007;38:505–16.
Pottgiesser C, Ovelhey A, Ziller M, Kramer M, Selhorst T, Conraths FJ.
Potential risk factors associated with bovine spongiform encephalopathy in
cattle from Scheswing-Holstein, Germany. J Vet Med B Infect Dis Vet Public
Health. 2006;53:306–11.
Taylor DM, Woodgate SL, Atkinson MJ. Inactivation of the bovine spongiform
encephalopathy agent by rendering procedures. Vet Rec. 1995;137:605–10.
European Food Safety Authority. Opinion of the Scientific Panel on
Biological Hazards of the European Food Safety Authority on the "assessment
of the human and animal BSE risk posed by tallow with respect of residual
BSE risk." The EFSA Journal. 2005;221:1–47 [cited 2007 May 9].

Available from


Figure. Number of cases of bovine spongiform encephalopathy by calves' birth
year, Japan.

Suggested Citation for this Article

Tsutsui T, Yamamoto T, Hashimoto S, Nonaka T, Nishiguchi A, Kobayashi S.
Milk replacers and bovine spongiform encephalopathy in calves, Japan
[letter]. Emerg Infect Dis [serial on the Internet]. 2008 Mar [date cited].
Available from

Report on Food & Drug Administration Dallas District Investigation of
Bovine Spongiform Encephalopathy Event in Texas 2005

Executive Summary:


Feed Investigation:

As information was learned about the index herd, FDA Investigators working
with TAHC officials conducted multiple interviews with the producer of the
animal regarding possible feeds, feed sources, animal husbandry practices,
and other events which may have changed normal feeding practices over the
course of the index animal’s life in the herd and any other information
which may have been helpful in identifying the possible sources of feed for
this animal and herd. FDA corroborated this information through interviews
at the retail feed supply stores where the producer purchased feeds.

Follow-up at these retail feed supply stores identified 21 possible feed
products the producer may have used during the history of the herd. Fifteen
purchased feed products were identified, along with hay, native grass, rice
straw, soybean meal, milk replacer/colostrum and bagged corn. These products
were identified as originating from nine different manufacturers. Each of
these manufacturers was inspected by FDA Dallas District and TFFCS

Feed #19 - Milk Replacer
Since 2000, Infrequent use
Dehydrated colostrums, whey

see full text ;

again, the false claims of the infamous 8/4/97 were made here. fact is, it
was nothing but ink on paper. ...tss

ALABAMA atypical BSE h-BASE case feed history ???

To ensure that adequate feed controls were in place in the feed facilities
in the immediate geographic area of the index farm, FDA conducted a feed
investigation into local feed mills that may have supplied feed to the index
animal after the 1997 feed ban. This investigation found that all local feed
mills that handle prohibited materials have been and continue to be in
compliance with the FDA’s feed ban.

i beg to differ.

and this is just what i found on a quick search, tons and tons. .....tss


Date: September 6, 2006 at 7:58 am PST


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.



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


Dairy and poultry feeds were possibly contaminated with ruminant based


477.72 tons



MS, AL, GA, AND TN 11,000+ TONS

Date: August 16, 2006 at 9:19 am PST



Bulk custom dairy pre-mixes, Recall # V-120-6



Ware Milling Inc., Houston, MS, by telephone on June 23, 2006. Firm
initiated recall is complete.


Possible contamination of dairy animal feeds with ruminant derived meat and
bone meal.


350 tons


AL and MS



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


All products manufactured from 02/01/2005 until 06/20/2006


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.


Poultry and fish feeds which were possibly contaminated with ruminant based
protein were not labeled as "Do not feed to ruminants".


7,541-50 lb bags


AL, GA, MS, and TN



TONS Products manufactured from 02/01/2005 until 06/06/2006

Date: August 6, 2006 at 6:16 pm PST


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;
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;
net wt 50 Lbs, Recall # V-110-6;
Recall # V-111-6;
Recall # V-112-6


Product manufactured from 02/01/2005 until 06/06/2006


Alabama Farmers Cooperative, Inc., Decatur, AL, by telephone, fax, email and
visit on June 9, 2006. FDA initiated recall is complete.


Animal and fish feeds which were possibly contaminated with ruminant based
protein not labeled as "Do not feed to ruminants".


125 tons


AL and FL



Our investigation also found that you hold animals on your farm under
conditions that are so inadequate that diseased animals and/or medicated
animals bearing potentially harmful drug residues are likely to enter the
food supply. For example, you failed to maintain treatment records for bull
calves fed medicated milk replacer, lack a system for assuring that the milk
replacer is used in a manner not contrary to label instructions, and lack a
system for assuring the medicated animals have been withheld from slaughter
for appropriate periods of time to permit depletion of potentially hazardous
drug residues from edible tissues. Foods from animals held under such
conditions are adulterated under Section 402(a)(4) of the Act [21 U.S.C.
Section 342(a)(4)].

Vol. 9 No. 2 April 2004
Table of Contents - Page 3
Dairy Review


What Do These Changes Mean To Producers?
Livestock producers who have been feeding any of the
now prohibited blood products, poultry litter or plate waste
will now have to find alternative protein sources to feed.
The new changes also may impact calf health on some
farms. Prohibition of products derived from ruminant blood
and blood products will include colostrum replacers and
supplements and milk replacer supplements made from bovine
serum or plasma. While colostrum supplements derived from
milk or colostrum will still be available, there is evidence that
the IgG absorption from these products is less than that from
supplements derived from bovine plasma. Some of the
products that will no longer be available include Lifeline™,
Acquire™, Secure!™, NutraPro B™, and Gammulin™.
Producers using these products will need to find alternative
products and focus more attention on quality colostrum
management to ensure healthy calves.
It is important to note that tallow and animal fat are not
prohibited under the new BSE feed rule. The rendering process
effectively separates fat from protein, and since the prion
believed to cause BSE is a protein, feeding tallow is not
considered a risk for spreading.


PLEASE NOTE, these changes above that were promised, were never kept. ...TSS


Monday, Jan. 26, 2004
FDA Press Office

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

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
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

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

"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
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


Blood-borne contamination may be a special problem where spray-dried blood
is being used as a milk replacer for calves, as it is
thought that young animals are especially susceptible to infection.

Certainly, blood and blood proteins should not be used as feed without
conclusive evidence that they are safe.


Paul W. Brown, M.D.
Medical Director, USPHS, and Senior Investigator, NIH (retired)
Consultant, TSE Risk Management
7815 Exeter Rd.
Bethesda, MD 20814
Fax 301-652-4312

Neil R. Cashman MD
Professor, Department of Medicine (Neurology)
Diener Chair of Neurodegenerative Diseases
Centre for Research in Neurodegenerative Diseases
6 Queen's Park Crescent West
Toronto Ontario M5S3H2
Ph: 416-978-1875
Fax: 416-978-1878

Linda A. Detwiler, DVM
Consultant, TSE Risk Management
225 Hwy 35
Red Bank, NJ 07701
Ph 732-741-2290
Fax 732-741-7751

Laura Manuelidis, MD
Professor and Head of Neuropathology,
Department of Surgery and Faculty of Neurosciences
Yale Medical School
333 Cedar St.
New Haven, CT 06510
Tel: 203-785-4442

Jason C. Bartz, Ph.D.
Assistant Professor
Department of Medical Microbiology and Immunology
Creighton University
2500 California Plaza
Omaha, NE 68178
(402) 280-1811 voice
(402) 280-1875 fax

Robert B. Petersen, Ph.D.
Associate Professor of Pathology and Neuroscience
Case Western Reserve University
5-123 Wolstein Building
2103 Cornell Road
Cleveland, OH 44106-2622
Phone 216-368-6709
FAX 360-838-9226

Robert G. Rohwer, Ph.D.
Director, Molecular Neurovirology Laboratory
Veterans Affairs Medical Center
Medical Research Service 151
Assoc. Professor of Neurology
School of Medicine
University of Maryland at Baltimore
10 N. Greene St.
Baltimore, MD 21201
ph. 410-605-7000 x6462
Fax 410-605-7959

FDA Proposed Rule December 20, 2005

APHIS-2006-0041-0006 TSE advisory committee for the meeting December 15,




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