Final Feed Investigation Summary - California BSE Case - July 2012
On Tuesday, April 24, 2012, the California Department of Food and
Agriculture (CDFA) and the U.S. Food and Drug Administration (FDA) were informed
by the CDFA Animal Health Safety Service (AHSS) Division that a brain sample
collected from a dead cow at the Baker Commodities rendering transfer station in
Hanford, California tested positive for L-type atypical bovine spongiform
encephalopathy (BSE). While cases of classical BSE have been clearly linked to
the use of contaminated meat and bone meal (MBM) as an ingredient in cattle
feed, the origin of atypical strains of BSE is unknown. Given the scientific
uncertainty about the origin of the L-type strain of BSE, FDA and CDFA conducted
a feed investigation to try to determine if any feed supplied to the index
premises since the birth of the index cow could have been manufactured with or
cross-contaminated by ingredients that are prohibited for use in feed for
ruminant animals.
FDA published BSE feed regulations in 1997 and 2008 to protect against
cattle exposure to the BSE agent through animal feed. The 1997 “feed ban” (21
CFR 589.2000) prohibits feeding mammalian protein, with certain exceptions such
as for milk products and blood products, to ruminants. The 2008 “enhanced feed
rule” (21 CFR 589.2001) addresses concerns that the 1997 rule might not
completely eliminate the potential for cattle to be exposed to infectivity as a
result of cross-contamination during feed manufacturing or distribution, or as a
result of on-farm misfeeding of swine feed, poultry feed, or pet food to cattle.
To further reduce the BSE risks associated with cross-contamination and on-farm
misfeeding, the 2008 rule banned the use of the highest risk cattle tissues -
the brain and spinal cord from cattle 30 months of age and older - in all animal
feed.
To investigate whether the BSE positive cow in California had access to
feed ingredients containing bovine origin MBM, the CDFA and the FDA visited the
index dairy farm where they evaluated the dairy farm’s compliance with BSE feed
regulations, obtained the feeding history of the index cow since her birth in
September 2001 to the present, and identified all feed suppliers to those
premises where the cow had resided since birth. An inspection for compliance
with 21 CFR 589.2000 and 589.2001 (a BSE inspection) was then conducted at each
of the feed suppliers identified. In addition, inspection reports from all
previous inspections at the identified feed firms were reviewed to determine
each firm’s history of using prohibited material in feed manufacturing, as well
as each firm’s history of compliance with FDA’s BSE feed regulations. Particular
attention was focused on controls in place at each facility to prevent cross
contamination.
Review of the BSE inspection histories found that compliance with BSE feed
regulations was excellent. None of the facilities had used prohibited material
in their feed manufacturing during the entire period of interest. All historical
BSE inspections at the 12 feed suppliers were NAI (no action indicated) for all
inspections conducted over the period of interest. One facility had minor
violations (VAI, or voluntary action indicated) for medicated feed good
manufacturing practices (GMP) deficiencies. Prior to the period of interest, one
firm was OAI for an April 2000 inspection because the firm had inadequate
cleanout procedures and failed to label product potentially containing
prohibited material with the required caution statement “do not feed to cattle
or other ruminants”. The next inspection of that facility, in May 2001 (6 months
before the date of birth of the index cow), found that the facility no longer
used prohibited material.
Although none of the facilities had used prohibited material in their feed
manufacturing during the entire period of interest, one facility distributed
prohibited material but did not use it to manufacture feeds. This facility
maintained separation between its manufactured feed and products for
distribution that contained prohibited material. Six facilities used only
vegetable origin protein sources such as whole and rolled corn, soybean meal,
canola meal, distillers dried grain, corn gluten, wheat, almond hulls, rolled
barley, cottonseed, sunflower meal, and beet pulp. Five facilities used blood
meal (one of the five used only porcine origin blood meal). Two used feather
meal, two used fish meal, and one used porcine origin MBM. One facility
processed and manufactured with poultry waste. Three facilities distributed pet
food or sold it to retail customers. All three of these facilities kept the pet
food in an area of the facility separated from feed manufacturing, with posted
signs saying “do not feed to cattle or other ruminants.”
The reporting form used to conduct BSE inspections requires the
investigator to verify that facilities that do not use prohibited material have
safeguards in place to assure that the facility does not receive prohibited
material. All 12 firms had procedures in place for obtaining written
certification or other assurances from suppliers that products contained no
prohibited material. Written procedures at each facility also required that
plant personnel review labels of incoming product for prohibited ingredients.
The inspection reports showed that each feed supplier also had appropriate
procedures for ensuring that vehicles used to haul incoming or outgoing product
had either not previously hauled product containing prohibited material, or had
been properly cleaned.
This feed investigation found that no feed suppliers to the index premises
processed with prohibited material during the period of interest, that all feed
facilities obtained appropriate assurances from their suppliers that incoming
ingredients did not contain prohibited material, and that vehicle inspections
and/or driver certifications were used by all facilities to ensure that products
were not transported in vehicles that had hauled product containing prohibited
material in the previous load. Based on these findings, the feed investigation
team did not identify any conditions where feed ingredients supplied to the
index premises had been manufactured with prohibited material, or where feed
suppliers to the index premises did not have adequate safeguards in place to
prevent cross-contamination during feed manufacture, storage, or
transportation.
California 2004
USA BSE/TSE TRIPLE FIREWALLS SEEPING IN 2004...TSS
Public Health Service Food and Drug Administration
San Francisco District 1431 Harbor Bay Parkway Alameda, CA 94502-7070
Telephone: 510/337-6700
VIA HAND DELIVERY
Our Reference No. 1000123954
June 23, 2004
Ronald M. Foster, Manager Randall C. Boyce, Manager Trevor O. Foster,
Manager George P. Foster, Manager Fresno Farming LLC P.O. Box 457 1000 Davis
Street Livingston, California
WARNING LETTER
Dear Mssrs. Foster, Boyce, Foster, and Foster:
The U.S. Food and Drug Administration (FDA) conducted an inspection of your
medicated animal feed mill operation, Fresco Farming LLC, located in Traver,
California from April 14, 2004 through May 6, 2004, and found significant
deviations from the requirements set forth in Title 21, Code of Federal
Regulations, Section 589.2000 (21 C.F.R. 589.2000) - Animal Proteins Prohibited
in Ruminant Feed. The regulation is intended to prevent the establishment and
amplification of Bovine Spongiform Encephalopathy (BSE). Because you failed to
follow this rule, products you manufactured and distributed are adulterated
within the meaning of Section 402(a)(4) of the Federal Food, Drug, and Cosmetic
Act (the Act) because they were prepared, packed, or held under insanitary
conditions whereby they may have been rendered injurious to health.
Our inspection found the following violations of 21 C.F.R. 589.2000:
1. Failure to provide for measures to avoid commingling or
cross-contamination of products that contain or may contain protein derived from
mammalian tissues into animal protein or feeds that may be used for ruminants to
comply with 21 C.F.R. 589.2000(e)(1)(iii).
* Your firm uses a vacuum system to clean up spilled product in the tunnel
area. This tunnel area houses the two receiving conveyor systems and the
elevators for the two conveyor systems. When product, including ruminant meat
and bone meal, is spilled onto the floor of this area, the spilled product is
vacuumed up by the vacuum system and, via a discharge hose, was placed into a
conveyor system that your firm had designated as free of ruminant meat and bone
meal. Your firm admitted that it was unaware of the vacuum system discharging
into the conveyor systems designated as free of ruminant meat and bone meal and
that this had been in place since April 2003. Your firm remedied this problem
during FDA s April/May 2004 inspection by removing the discharge hose connection
to the conveyer system that your firm had designated as free of ruminant meat
and bone meal . * Your firm uses a dust collection system that pulls dust from
systems that receive both ruminant meat and bone meal and feed ingredients
intended for ruminants. This dust system then discharged collected product back
into the two conveyor systems via a cross connection, thereby making it likely
that ruminant meat and bone meal became commingled with ruminant feed
ingredients. Your firm admitted that it was unaware of the cross connection and
that it had been in place since April 2003. Your firm removed the cross
connection during FDA s April/May 2004 inspection.
2. Failure to maintain written procedures specifying the clean-out
procedure or other means, and specifying the procedures for separating products
that contain or may contain protein derived from mammalian tissue from all other
protein products from the time of receipt until the time of shipment, to comply
with 21 C.F.R. 589.2000(e)(1)(iv). This observation was also noted during FDA s
July/August 2003 inspection of your firm.
* There are no written procedures for separating products that contain
prohibited material from ingredients used in ruminant feeds from the time of
receipt until the time of shipment. * The written procedure for cleaning out or
flushing equipment after mixing feeds containing prohibited material was not
adequate to prevent contamination of ruminant feed with prohibited material.
3. Failure to maintain records sufficient to track materials that contain
protein derived from mammalian tissues throughout their receipt, processing, and
distribution to comply with 21 C.F.R. 589.2000(e)(1)(i). This observation was
also noted during FDA s July/August 2003 inspection of your firm.
* Specifically, your firm has failed to develop and implement complete
written procedures to separate ruminant meat and bone meal from feed ingredients
intended for ruminants from the time of receipt until the time of distribution.
The written procedures that do exist fail to address the use of equipment common
to ruminant meat and bone meal and ruminant feed ingredients.
The above is not intended to be an all-inclusive list of deficiencies at
your facility. As a manufacturer of materials intended for use as animal feed,
you are responsible for assuring that 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 such violations do not recur. Failure to promptly correct these
violations may result in regulatory action without further notice, such as
seizure and/or injunction.
You should notify this office in writing within fifteen (15) working days
of receiving this letter of the steps you have taken to bring your firm into
compliance with the law. Your response should include an explanation of each
step being taken to correct the violations and prevent their recurrence. If
corrective actions cannot be completed in fifteen (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 that corrections
have been made.
Please send your reply to the U.S. Food and Drug Administration, Attention:
Ms. Harumi Kishida, Compliance Officer, 1431 Harbor Bay Parkway, Alameda,
California 94502-7070. If you have questions regarding this letter, please
contact Ms. Kishida at (510) 337-6824.
Sincerely,
/s/
CD Moss, Acting DD for Barbara J. Cassens District Director San Francisco
District
cc: VIA CERTIFIED MAIL RETURN RECEIPT REQUESTED C. Michael Blasco, Feed
Mill Manager Fresno Farming LLC P.O. Box 430 Traver, California 93673
a review of the staggering amount of banned mad cow protein in commerce in
the USA since the partial and voluntary FDA ban of August 4, 1997. ...
2011
Ohio Department of Agriculture and Ohio Department of Health
Governor
John R. Kasich
Lieutenant Governor
Mary Taylor
ODA Director
James Zehringer
ODH Director
Theodore E. Wymyslo, M.D.
DT: July 14, 2011
TO: Health Commissioners, Directors of Environmental Health and Interested
Parties
RE: Recall Announcement (ODA/ODH) 2011-076
Valley Farm Meats (DBA Strasburg Provision, Inc) Issues Precautionary
Recall for Beef Products Due to Possible Contamination with Prohibited
Materials
[STRASBURG, Ohio] – Valley Farm Meats (DBA Strasburg Provision, Inc) of
Strasburg, OH announces a voluntary recall of an unknown amount of beef products
that may contain the spinal cord and vertebral column, which are considered
specified risk materials (SRMs). SRMs must be removed from cattle over 30 months
of age in accordance with federal and state regulations. SRMs are tissues that
are known to contain the infective agent in cattle infected with Bovine
Spongiform Encephalopathy (BSE), as well as materials that are closely
associated with these potentially infective tissues. Therefore, federal and
state regulations prohibit SRMs from use as human food to minimize potential
human exposure to the BSE agent.
The products subject to recall include all beef products slaughtered and
processed by or purchased from Valley Farm Meats retail store, 1317 N. Wooster
Ave NW, Strasburg, OH 44680 or purchased from Ed Lind Livestock and Poultry,
3333 Church Rd B, Medina, Ohio 44256. These products were produced between
01/28/2011 and 07/05/2011 and offered for sale from 01/28/2011 through
07/11/2011.
The package labels or beef carcasses may bear the Ohio mark of inspection
and “Est. 80”, however products processed through Ed Lind Livestock and Poultry
may not contain such markings. The problem was discovered through routine
inspection activities by the Ohio Department of Agriculture’s Division of Meat
Inspection. The Department has received no reports of illnesses associated with
consumption of this product.
The United States Department of Agriculture’s Food Safety and Inspection
Service classifies this type of potential contamination as a low health risk,
however individuals concerned about an illness should contact a health care
provider. Because of potential product contamination, Valley Farm Meats urges
its customers who have purchased the suspect product(s) not to eat them and to
return them to the company. Customers may bring those designated packages to
Valley Farm Meats, 1317 N Wooster Avenue NW, Strasburg, OH 44680 during regular
business hours or call the company’s owner, Paul Berry at 330-878-5557.
North Dakota Firm Recalls Whole Beef Head Products That Contain Prohibited
Materials
Recall Release CLASS II RECALL FSIS-RC-023-2010 HEALTH RISK: LOW
Congressional and Public Affairs (202) 720-9113 Catherine Cochran
WASHINGTON, April 5, 2010 - North American Bison Co-Op, a New Rockford,
N.D., establishment is recalling approximately 25,000 pounds of whole beef heads
containing tongues that may not have had the tonsils completely removed, which
is not compliant with regulations that require the removal of tonsils from
cattle of all ages, the U.S. Department of Agriculture's Food Safety and
Inspection Service (FSIS) announced today.
Tonsils are considered a specified risk material (SRM) and must be removed
from cattle of all ages in accordance with FSIS regulations. SRMs are tissues
that are known to contain the infective agent in cattle infected with Bovine
Spongiform Encephalopathy (BSE), as well as materials that are closely
associated with these potentially infective tissues. Therefore, FSIS prohibits
SRMs from use as human food to minimize potential human exposure to the BSE
agent.
The product subject to recall includes: Various weight cases of "Beef Heads
KEEP FROZEN." Each case bears the establishment number "EST. 18859" inside the
USDA mark of inspection and a case code number "16999." "North Dakota Natural
Beef" is printed in the bottom left-hand corner of each label.
The recalled products were produced between June 25, 2009, and February 19,
2010. These products were shipped to distribution centers in Md., Mich., and
Minn. for further sale.
The problem was discovered during FSIS inspection activities at the
establishment. FSIS routinely conducts recall effectiveness checks to verify
recalling firms notify their customers of the recall and that steps are taken to
make certain that the product is no longer available to consumers.
Media with questions about the recall should contact Philip Wicke, Vice
President of Operations, at (701) 356-7723. Consumers with questions about the
recall should contact Jeremy Anderson, Director of Customer Service, at (952)
545-2495.
Consumers with food safety questions can "Ask Karen," the FSIS virtual
representative available 24 hours a day at AskKaren.gov. The toll-free USDA Meat
and Poultry Hotline 1-888-MPHotline (1-888-674-6854) is available in English and
Spanish and can be reached from l0 a.m. to 4 p.m. (Eastern Time) Monday through
Friday. Recorded food safety messages are available 24 hours a day. #
Missouri Firm Recalls Cattle Heads That Contain Prohibited Materials
Recall Release CLASS II RECALL FSIS-RC-021-2008 HEALTH RISK: LOW
Congressional and Public Affairs (202) 720-9113 Amanda Eamich
WASHINGTON, June 26, 2008 – Paradise Locker Meats, a Trimble, Mo.,
establishment, is voluntarily recalling approximately 120 pounds of fresh cattle
heads with tonsils not completely removed, which is not compliant with
regulations that require the removal of tonsils from cattle of all ages, the
U.S. Department of Agriculture’s Food Safety and Inspection Service announced
today.
Tonsils are considered a specified risk material (SRM) and must be removed
from cattle of all ages in accordance with FSIS regulations. SRMs are tissues
that are known to contain the infective agent in cattle infected with BSE, as
well as materials that are closely associated with these potentially infective
tissues. Therefore, FSIS prohibits SRMs from use as human food to minimize
potential human exposure to the BSE agent.
The products subject to recall include: Boxes of “BEEF HEAD, PARADISE
LOCKER MEATS.” Each shipping package bears the establishment numbers “EST.
31865” inside the USDA mark of inspection.
These products were sent to retail establishments and restaurants in the
Kansas City, Kansas, area.
The problem was discovered through routine FSIS inspection that verified
there had been incomplete removal of the tonsils by the recalling
establishment.
Media and consumers with questions about the recall should contact company
Production Supervisor Louis Fantasma at (816) 370-6328.
Consumers with food safety questions can “Ask Karen,” the FSIS virtual
representative available 24 hours a day at AskKaren.gov. The toll-free USDA Meat
and Poultry Hotline 1-888-MPHotline (1-888-674-6854) is available in English and
Spanish and can be reached from l0 a.m. to 4 p.m. (Eastern Time) Monday through
Friday. Recorded food safety messages are available 24 hours a day. #
SEE FULL TEXT HERE ;
Tuesday, July 1, 2008
Missouri Firm Recalls Cattle Heads That Contain Prohibited Materials
SRMs
Sunday, October 18, 2009
Wisconsin Firm Recalls Beef Tongues That Contain Prohibited Materials SRM
WASHINGTON, October 17, 2009
Thursday, October 15, 2009
Nebraska Firm Recalls Beef Tongues That Contain Prohibited Materials SRM
WASHINGTON, Oct 15, 2009
Thursday, June 26, 2008
Texas Firm Recalls Cattle Heads That Contain Prohibited Materials
Friday, August 8, 2008
Texas Firm Recalls Cattle Heads That Contain Prohibited Materials SRMs
941,271 pounds with tonsils not completely removed
Saturday, April 5, 2008
SRM MAD COW RECALL 406 THOUSAND POUNDS CATTLE HEADS WITH TONSILS
KANSAS
Wednesday, April 30, 2008
Consumption of beef tongue: Human BSE risk associated with exposure to
lymphoid tissue in bovine tongue in consideration of new research findings
Wednesday, April 30, 2008
Consumption of beef tongue: Human BSE risk associated with exposure to
lymphoid tissue in bovine tongue in consideration of new research findings
Friday, October 15, 2010
BSE infectivity in the absence of detectable PrPSc accumulation in the
tongue and nasal mucosa of terminally diseased cattle
SPECIFIED RISK MATERIALS SRMs
oh God, this is going to be long. there are too many mad cow feed ban
warning letters and recalls of mad cow feed in commerce to list all of them here
now, but here are a few 1000s+ tonnages of banned mad cow protein in commerce
since the partial and voluntary mad cow feed ban was put into place August 4,
1997. this is not all by any means, just a few old warning letters in my files.
remember, .005 gram is lethal. let’s start from 2007, the last year that the FDA
et al publically published the mad cow feed ban warning letters, and then we
will go back year by year, to August 4, 1997, when the partial and voluntary mad
cow feed ban was put into effect...or rather inked on paper, because that’s
about all that happened...TSS
2007
10,000,000+ LBS. of PROHIBITED BANNED MAD COW FEED I.E. BLOOD LACED MBM IN
COMMERCE USA 2007
Date: March 21, 2007 at 2:27 pm PST
RECALLS AND FIELD CORRECTIONS: VETERINARY MEDICINES -- CLASS II
PRODUCT
Bulk cattle feed made with recalled Darling's 85% Blood Meal, Flash Dried,
Recall # V-024-2007
CODE
Cattle feed delivered between 01/12/2007 and 01/26/2007
RECALLING FIRM/MANUFACTURER
Pfeiffer, Arno, Inc, Greenbush, WI. by conversation on February 5, 2007.
Firm initiated recall is ongoing.
REASON
Blood meal used to make cattle feed was recalled because it was cross-
contaminated with prohibited bovine meat and bone meal that had been
manufactured on common equipment and labeling did not bear cautionary BSE
statement.
VOLUME OF PRODUCT IN COMMERCE
42,090 lbs.
DISTRIBUTION
WI
___________________________________
PRODUCT
Custom dairy premix products:
MNM ALL PURPOSE Pellet, HILLSIDE/CDL Prot- Buffer Meal, LEE, M.-CLOSE UP PX
Pellet, HIGH DESERT/ GHC LACT Meal, TATARKA, M CUST PROT Meal, SUNRIDGE/CDL
PROTEIN Blend, LOURENZO, K PVM DAIRY Meal, DOUBLE B DAIRY/GHC LAC Mineral, WEST
PIONT/GHC CLOSEUP Mineral, WEST POINT/GHC LACT Meal, JENKS, J/COMPASS PROTEIN
Meal, COPPINI - 8# SPECIAL DAIRY Mix, GULICK, L-LACT Meal (Bulk), TRIPLE J -
PROTEIN/LACTATION, ROCK CREEK/GHC MILK Mineral, BETTENCOURT/GHC S.SIDE MK-MN,
BETTENCOURT #1/GHC MILK MINR, V&C DAIRY/GHC LACT Meal, VEENSTRA, F/GHC LACT
Meal, SMUTNY, A- BYPASS ML W/SMARTA, Recall # V-025-2007
CODE
The firm does not utilize a code - only shipping documentation with
commodity and weights identified.
RECALLING FIRM/MANUFACTURER
Rangen, Inc, Buhl, ID, by letters on February 13 and 14, 2007. Firm
initiated recall is complete.
REASON
Products manufactured from bulk feed containing blood meal that was cross
contaminated with prohibited meat and bone meal and the labeling did not bear
cautionary BSE statement.
VOLUME OF PRODUCT IN COMMERCE
9,997,976 lbs.
DISTRIBUTION
ID and NV
END OF ENFORCEMENT REPORT FOR MARCH 21, 2007
2006
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
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
###
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
###
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
###
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
###
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
###
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
2005
Subject: MAD COW FEED BAN WARNING LETTER December 21, 2005
Date: January 10, 2006 at 7:18 am PST Public Health Service Food and Drug
Administration
Kansas City District Southwest Region 11630 West 80th Street Lenexa, Kansas
66214-3340
December 21, 2005
CERTIFIED MAIL RETURN RECEIPT REQUESTED
WARNING LETTER
Ref. KAN 2006-08
Mr. Paul Rasmussen, President Gold Eagle Cooperative Board of Directors
1145 Birch Ave Corwith, IA 50430
Dear Mr. Rasmussen:
An investigator from our office conducted two inspections of your animal
feed manufacturing operations at 415 N. Locust St., Goldfield, Iowa on August 23
and August 25 -26, 2005. During these inspections, a significant deviation from
the requirements set forth in Title 21, Code of Federal Regulations (CFR), Part
589 .2000 [21 CFR 589 .2000] - Animal Proteins Prohibited in Ruminant Feed, was
identified . The regulation is intended to prevent the establishment and
amplification of Bovine Spongiform Encephalopathy (BSE). Our investigation found
a failure to label one of your products, "ISLACT - IS LACTATION," a swine feed,
with the statement "Do Not Feed to Cattle or Other Ruminants," as required by 21
CFR 589 .2000(d) . Although your swine feed is not formulated with protein
derived from mammalian tissues as defined in 21 CFR 589 .2000(a)(1), which is
prohibited in ruminant feed, your production practices may cause the finished
product to contain such material. Our investigator found that your firm does not
have a strategy for sequencing feeds and does not flush or otherwise clean
shared production equipment between the manufacture of poultry feed formulated
with protein derived from mammalian tissues and swine feed formulated without
such material . As a result, swine feed may acquire protein derived from
mammalian tissue from poultry feed residue remaining on the shared production
equipment. Your failure to label your "ISLACT - IS LACTATION" swine feed with
the statement "Do Not Feed to Cattle or Other Ruminants" causes it to be
misbranded under section 403(a)(1) of the Act.
The above is not intended to be an all-inclusive list of deficiencies at
your facility. As a manufacturer of animal feed, you are responsible for
ensuring that your overall operation and the products you manufacture and
distribute comply with the law.
You should take prompt action to correct this violation and establish a
system whereby such violations do not recur. Failure to promptly correct this
violation may result in regulatory action, such as seizure and/or injunction,
without further notice.
You should notify this office in writing of the steps you have taken to
bring your firm into compliance with the law within fifteen (15) working days of
receiving this letter. Your response should include an explanation of each step
being taken to correct the violation and prevent its recurrence. If corrective
action cannot be completed within fifteen (15) working days, state the reason
for the delay and the date by which the corrections will be completed. Please
include copies of any available documentation demonstrating that corrections
have been made.
Please send your reply to the Food and Drug Administration, Attention:
Ralph Gray, Compliance Officer, 11630 West 80th Street, Lenexa, KS 66214-3340.
Sincerely, /s/
C.R. Pendleton for John W. Thorsky District Director Kansas City District
2005
-------- Original Message --------
Subject: MAD COW FEED BAN WARNING LETTER Petrolia TEXAS
Date: Tue, 8 Feb 2005 08:30:48 –0600
From: "Terry S. Singeltary Sr."
Reply-To: Bovine Spongiform Encephalopathy
##################### Bovine Spongiform Encephalopathy
#####################
Public Health Service Food and Drug Administration
Dallas District 4040 North Central Expressway Dallas, Texas 75204-3145
January 12, 2005
Ref: 2005-DAL-WL-11
WARNING LETTER
CERTIFIED MAIL RETURNED RECEIPT REQUESTED
Mr. William L. Brown, Owner Brown Cattle Company 1 Feed Lot Road P.O. Box
281 Petrolia, TX 76377
Dear Mr. Brown:
An inspection of your ruminant feeding operation located at 1 Feed Lot
Road, Petrolia, Texas, was conducted on August 24 and September 8, 2004 by an
Investigator from the Food and Drug Administration (FDA). The inspection found
significant deviations from the requirements set forth in Title 21, Code of
Federal Regulations, Part 589.2000 - Animal Proteins Prohibited in Ruminant Feed
(21 CFR 589.2000). This regulation is intended to prevent the establishment and
amplification of Bovine Spongiform Encephalopathy (BSE).
Our inspection revealed that you feed prohibited material, as defined by 21
CFR 598.2000(a), to ruminants. This prohibited material consists of human food
processing waste, which is derived from corn dog manufacturing and contains hot
dogs and corn dogs. Inspected meat products that have been cooked and offered
for human food and further heat processed for animal feed are not prohibited
material. This is more fully described in Guidance for Industry 76, which was
previously provided to your firm. The human food processing waste you are using
has not been further heat processed. The failure to further heat process this
material causes the feed to be adulterated within the meaning of Section
402(a)(2)(C)(i) of the Federal, Food, Drug, and Cosmetic Act.
During our previous inspection on January 17, 2002, copies of the BSE
Guidance documents 69, 70 and 76 and 21 CFR 589.2000, the BSE regulation, were
provided to and discussed with you.
Failure to correct these violations may result in FDA taking regulatory
action without further notice including, but not limited to, seizure and/or
injunction.
It is necessary for you to take action on this matter now. Please notify
this office in writing within fifteen (15) working days from the date you
received this letter. Your response should specifically identify the actions you
are taking to correct the violations and provide specific timeframes for
achieving compliance. Also, as part of your written response, you should provide
information regarding the current feeding practices followed at your facility
and information pertaining to the planned marketing of your animals. Your reply
should be sent to Edwin Ramos, Compliance Officer, at the above stated address.
If you have any questions concerning the stated matters, you may contact Mr.
Ramos at 214-253-5218.
Sincerely,
/s/
Michael A. Chappell
Dallas District Director
TSS
######### https://listserv.kaliv.uni-karlsruhe.de/warc/bse-l.html
##########
2004
-------- Original Message --------
Subject: ''HOLY MAD COW'', USA NOW POSTING MAD COW FEED BAN WARNING LETTERS
AGAIN WITH SICK SICK COWS
Date: Tue, 20 Apr 2004 08:31:34 –0500
From: "Terry S. Singeltary Sr."
Reply-To: Bovine Spongiform Encephalopathy
To: BSE-L@uni-karlsruhe.de
######## Bovine Spongiform Encephalopathy #########
Public Health Service Food and Drug Administration
Cincinnati District Office Central Region 6751 Stager Drive Cincinnati, OH
45237-3097 Telephone: (513) 679-2700 FAX: (513) 679-2771
VIA FEDERAL EXPRESS
April 8, 2004
Mr. Thomas S. Hurst, Jr., Owner Bardstown Mill, Inc. 204 W. Muir St
Bardstown, KY 40004
WARNING LETTER CIN-04-20830
On January 7,21-22, 2004, a Food and Drug Administration investigator
conducted an inspection of your feed mill located at 204 W. Muir St., Bardstown,
KY 40004. The inspection revealed significant deviations from the requirements
set forth in Title 21, Code of Federal Regulations, Part 589.2000 - Animal
Proteins Prohibited in Ruminant Feed. This regulation is intended to prevent the
establishment and amplification of Bovine Spongiform Encephalopathy (BSE).
Our inspection found your firm failed to label feeds or mark the invoices
of feeds that contain, or may contain, prohibited materials with the required
cautionary statement Do Not Feed To Cattle Or Other Ruminants . We suggest this
statement be distinguished by different type size or color or other means of
highlighting the statement so it is easily noticed by the purchaser.
The deviations from the BSE regulations, as noted above, cause products
being manufactured and distributed by your facility to be misbranded within the
meaning of Section 403(a)(1) of the Federal Food Drug and Cosmetic Act (the
Act).
This letter is not intended to be an all-inclusive list of deficiencies at
your facility. As a manufacturer of materials intended for animal feed use, you
are responsible for assuring that your overall operation and the products you
manufacture and distribute are in compliance with the law. We have enclosed a
copy of the FDA s Small Entity Compliance Guide to assist you with complying
with the regulation. 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 without
further notice. Such actions include seizure and/or injunction.
You should notify this office in writing within fifteen (15) working days
of the receipt of this letter of the steps you have taken to bring your firm
into compliance with the law. Your response should include an explanation of
each step being taken to correct the CGMP 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 that corrections
have been made.
Your response should be directed to Stephen J. Rabe, Compliance Officer at
the address listed above.
Sincerely,
/s/
Carol A. Heppe District Director Cincinnati District
Attachment: Small Entity Compliance Guide
Public Health Service Food and Drug Administration
Cincinnati District Office Central Region 6751 Steger Drive Cincinnati, OH
45237-3097 Telephone: (513) 679-2700 FAX: (513) 679-2771
April 8, 2004
WARNING LETTER via Federal Express
CIN-04-201679
Ralph K. Halter, President Halter Feed & Grain, Inc. 11501 Baywood
Street Robertsville, OH 44670
Dear Mr. Halter:
An inspection of your unlicensed feed mill, Halter Feed & Grain, Inc.,
located at 405 Tremont Ave. SW, Massilon, OH 44646, conducted by Food and Drug
Administration investigators, on 11/21 - 12/03/2003, found 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). Such deviations cause
products being manufactured and distributed by your facility to be adulterated
within the meaning of Section 402(a)(4) and misbranded within the meaning of
Section 403(f) of the Federal Food, Drug, and Cosmetic Act (the Act).
Our investigator found the following violations of 21 CFR 589.2000:
1) failure to label products that contain or may contain prohibited
materials with the caution statement - Do not feed to cattle or other
ruminants , as required by 21 CFR 589.2000(d)(1);
2) failure to establish and maintain written procedures, including
clean-out and flushing procedures, to avoid commingling and cross-contamination
of common equipment, as required by 21 CFR 589.2000(e)(1)(iv);
3) failure to maintain records sufficient to track prohibited materials
throughout their distribution in that you do not always document the customer
name or address for the sale and distribution of feeds containing meat and bone
meal, as required by 21 CFR 589.2000(d)(1).
The above is not intended as an all-inclusive list of CGMP violations. As a
manufacturer of materials intended for animal feed use, you are responsible for
assuring that your overall operation and the products you manufacture and
distribute are in compliance with the law.
You should notify this office, in writing, within fifteen (15) working days
of the receipt of this letter of the present operational status of this
facility. We understand that this facility may have been put out of production
by a fire that occurred on January 16, 2004. Since there is the possibility that
the facility will again be operational, you should include an explanation of
each step that will be taken to correct the violations and prevent their
recurrence.
Your response should be directed to Charles S. Price Compliance Officer,
U.S. Food and Drug Administration, 6751 Steger Drive, Cincinnati, OH 45237-3097.
If you have any questions regarding this letter, you may call Mr. Price at
telephone (513) 679-2700 extension 165.
Sincerely,
/s/
Carol A. Heppe District Director Cincinnati District
cc: George H. Snyder, Manager Halter Feed & Grain, Inc. P.O. Box 821
Massillon, OH 44648
snip...rest was antibiotic warning letters cause the animals were too sick
to slaughter...tss
Public Health Service Food and Drug Administration
Dallas District 4040 North Central Expressway Dallas, Texas 75204-3145
June 15, 2004
Ref: 2004-DAL-WL-18
WARNING LETTER
CERTIFIED MAIL RETURNED RECEIPT REQUESTED
Mr. Patrick O Ray, CEO & President Specialty Brands, Inc. P.O. Box
51467 Ontario, CA 91761-1057
Dear Mr. O Ray:
An inspection of your food manufacturing facility located at 601 E. 3rd
Street, Lampasas, Texas, was conducted on February 26 and March 1, 2004 by
Investigators from the Food and Drug Administration (FDA). The inspection found
significant deviations from the requirements set forth in Title 21, Code of
Federal Regulations, Section 589.2000 - Animal Proteins Prohibited in Ruminant
Feed (21 CFR 589.2000). This regulation is intended to prevent the establishment
and amplification of Bovine Spongiform Encephalopathy (BSE).
Our inspection revealed that your firm sells its reduction stream waste for
use as animal feed and that it contracted with [redacted] to dispose of this
manufacturing process stream waste. [redacted] used this process stream waste as
animal feed for ruminants.
At the close of the inspection, a list of inspectional observations (FDA
483) was issued to your firm and discussed with Mr. Anthony E. Rocz, Plant
Manager. The following violation was observed during the inspection:
Products that contain protein derived from mammalian tissues and that are
intended for use in animal feed must be labeled with the cautionary statement,
Do not feed to cattle or other ruminants, as required by 21 CFR
589.2000(d)(1). For example, your firm manufactures Mexican specialty food
products such as tortillas, taquitos, and burritos that contain beef. The
production process stream waste includes ground corn, product shells, and
filling material, it is then placed in a transportable bin for disposal by
feeding to livestock. This transportable waste bin did not bear the cautionary
statement Do Not Feed to Cattle or Other Ruminants.
Because your manufacturing stream waste did not bear this cautionary
statement, these products are misbranded within the meaning of section 403(a)(1)
of the Federal Food, Drug, and Cosmetic Act.
You should know that this serious violation of the law may result in FDA
taking regulatory action without further notice to you. These actions include,
but are not limited to, seizure and/or injunction.
We are in receipt of a letter from Mr. Anthony E. ROCZ, Plant Manager,
dated March 2, 2004, in which he stated that your factory was under a contract
with [redacted] to remove and dispose of the production stream waste generated
at the factory since April 15, 2003. Our investigators conveyed to Specialty
Brands, Inc., on February 24, 2004, that the disposal container was not properly
labeled to indicate that the material is not to be fed to cattle or other
ruminants in accordance with the BSE regulation. On February 26, 2004, our
investigators returned to your plant and conveyed to Mr. Rocz that earlier that
morning they observed cattle consuming the manufacturing stream waste supplied
by your firm to [redacted] The practice of supplying process stream waste to
[redacted] was indefinitely suspended on February 26, 2004. At that time, an
alternative waste removal service was obtained to dispose of the process stream
waste in a sanitary landfill facility and each load would be logged, a manifest
detailing the pounds of process waste disposed would be generated, and a
certification of proper disposal is to be provided for the record. This
alternative stream waste disposal process appears to be acceptable. Your letter
also states that your corporate Food Safety and Quality Assurance department is
in the process of drafting a corporate wide policy to ensure that all of your
factories are in compliance with the BSE regulation.
It is necessary for you to take prompt action on this matter now. Please
notify this office in writing within fifteen (15) working days from the date you
receive this letter of the specific actions you have taken to prevent the
recurrence of the violations, and when those actions were taken or will be taken
at your other corporate facilities having similar disposal plans. Your reply
should be sent to Edwin Ramos, Compliance Officer, at the above stated address.
If you have any questions concerning this letter, you may contact Mr. Ramos at
214-253-5218.
Sincerely,
/s/
Michael A. Chappell Dallas District Director
cc: Specialty Brands, Inc. Mr. Anthony E. Rocz, Plant Manager 601 E Third
Street Lampasas, TX 76550-2903
Public Health Service Food and Drug Administration
Dallas District 4040 North Central Expressway Dallas, Texas 75204-3145
June 10, 2004
Ref: 2004-DAL-WL-17
WARNING LETTER
CERTIFIED MAIL RETURNED RECEIPT REQUESTED
Mr. Jack Chapman, Owner Chapman Ranch 11071 CR 1255 Lampasas, TX 76550
Dear Mr. Chapman:
An inspection of your ruminant feeding operation located at 11071 CR 1255,
Lampasas, Texas, was conducted on February 26 and March 1, 2004 by Investigators
from the Food and Drug Administration (FDA). The inspection found significant
deviations from the requirements set forth in Title 21, Code of Federal
Regulations, Section 589.2000 - Animal Proteins Prohibited in Ruminant Feed (21
CFR 589.2000). This regulation is intended to prevent the establishment and
amplification of Bovine Spongiform Encephalopathy (BSE).
Our inspection revealed that you feed prohibited material, as defined by 21
CFR 589.2000(a), to ruminants. This prohibited material consists of
manufacturing process stream waste from [redacted] a manufacturer of products
such as fully cooked tacos, burritos, and taquitos that contain beef. This
manufacturing process stream waste contains meat products that have been cooked
and offered for human food but that have not been further heat processed for
feed. This failure to further heat process the material causes the feed to be
adulterated under section 402(a)(2)(C)(i) because it contains an unapproved food
additive (i.e., the meat products that have not been further heat processed for
feed).
At the close of the inspection, copies of the BSE Guidance documents 69, 70
and 76 were provided to you and further discussed. Also, you previously received
a copy of 21 CFR 589.2000, the BSE regulation, which was again explained in more
specific detail. You should know that this serious violation of the law may
result in FDA taking regulatory action without further notice to you. These
actions include, but are not limited to, seizure and/or injunction.
It is necessary for you to take action on this matter now. Please send a
written response to this office within fifteen (15) working days from the date
you receive this letter. Your response should specifically identify the actions
you are taking to correct the violations and provide specific timeframes for
achieving compliance. Also, as part of your written response, you should provide
information regarding the current feeding practices followed at your facility
and information pertaining to the planned marketing of your animals. Your reply
should be sent to Edwin Ramos, Compliance Officer, at the above stated address.
If you have any questions concerning this letter, you may contact Mr. Ramos at
214-253-5218.
Sincerely,
/s/
Michael A. Chappell Dallas District Director
horizonal rule
Public Health Service Food and Drug Administration
Atlanta District Office 60 8th Street, N.E. Atlanta, Georgia 30309
June 10, 2004
VIA FEDERAL EXPRESS
WARNING LETTER (04-ATL-13)
M. Dennis Burroughs President B & G Seed Company 591 Beck Road Hull,
Georgia 30646
Dear Mr. Burroughs:
An inspection of your feed mill was conducted by a Food and Drug
Administration (FDA) investigator on March 30, 2004. Our investigator determined
that you manufacture various products, including ruminant feeds, which are
animal feeds within the meaning of section 201(w) of the Federal Food, Drug, and
Cosmetic Act (the Act}. The inspection revealed significant deviations from the
requirements set forth in Title 21, Code of Federal Regulations (21 CFR), Part
589.2000 --Animal-Proteins Prohibited in Ruminant Feed. This regulation is
intended to prevent the establishment and amplification of Bovine Spongiform
Encephalopathy (BSE). The deviations cause the feed being manufactured and
distributed by your facility to be misbranded within the meaning of sections
403(a)(1) of the Act.
The inspection revealed that not all of your feeds that contain protein
derived from mammalian tissues and that are intended for use in animal feed
(prohibited material) were labeled with the statement Do not feed to cattle or
other ruminants, as required by 21 CFR 589.2000(d)(1) and (c)(1)(i). An example
is your B & G Pig Grower. In addition, you have routinely provided scrap or
salvage dog food containing prohibited material to be used as pig feed that was
not labeled with the required statement. In the case of bulk feed ingredients,
the statement could appear on the placard and invoice that accompany the
shipment. The lack of the required statement causes these feeds to be misbranded
as defined in section 403(a)(1) of the Act.
Our investigator also noted that you had failed to provide for adequate
measures to avoid commingling or cross-contamination of products that contain or
may contain prohibited material into feeds that may be used for ruminants, as
required under 21 CFR 589.2000(e)(1)(iii). You also failed to establish written
procedures for separating products which may contain prohibited material from
all other protein products from the time of receipt until the time of shipment,
as required under 21 CFR 589.2000(e)(1)(iv).
The above is not intended as an all-inclusive list of violations at your
firm. As a manufacturer of animal feeds, you are responsible for ensuring that
your overall operation and the products you manufacture and distribute are in
compliance with the law. We have included a copy of the FDA Guidance for
Industry 68 - Small Entities Compliance Guide - Protein Blenders, Feed
Manufacturers, and Distributors.
You should take prompt action to correct the above violations, and you
should establish procedures whereby such violations do not recur. Failure to
promptly correct these violations may result in regulatory action without
further notice, such as seizure and/or injunction.
You should notify this office, in writing, within fifteen (15) working days
of the receipt of this letter of the steps you have taken to bring your firm
into compliance with the law. Your response should include an explanation of
each step being taken to correct the violations and prevent their recurrence. We
do note that you initiated some corrective actions during the inspection,
including a feed recall and printing new labels. If corrective action cannot be
completed within 15 working days, state the reason for the delay and date by
which the corrections will be completed. Include copies of any available
documentation demonstrating that corrections have been made. Your response
should be directed to Philip S. Campbell, Compliance Officer, at the address
noted in the letterhead.
Sincerely,
/s/
Mary Woleske, Director Atlanta District
TSS
-------- Original Message --------
Subject: MAD COW FEED BAN WARNING LETTERS JULY 20, 2004 USA
Date: Tue, 20 Jul 2004 09:14:11 –0500
From: "Terry S. Singeltary Sr."
Reply-To: Bovine Spongiform Encephalopathy
To: BSE-L@uni-karlsruhe.de
######## Bovine Spongiform Encephalopathy #########
USA BSE/TSE TRIPLE FIREWALLS SEEPING IN 2004...TSS
Public Health Service Food and Drug Administration
San Francisco District 1431 Harbor Bay Parkway Alameda, CA 94502-7070
Telephone: 510/337-6700
VIA HAND DELIVERY
Our Reference No. 1000123954
June 23, 2004
Ronald M. Foster, Manager Randall C. Boyce, Manager Trevor O. Foster,
Manager George P. Foster, Manager Fresno Farming LLC P.O. Box 457 1000 Davis
Street Livingston, California
WARNING LETTER
Dear Mssrs. Foster, Boyce, Foster, and Foster:
The U.S. Food and Drug Administration (FDA) conducted an inspection of your
medicated animal feed mill operation, Fresco Farming LLC, located in Traver,
California from April 14, 2004 through May 6, 2004, and found significant
deviations from the requirements set forth in Title 21, Code of Federal
Regulations, Section 589.2000 (21 C.F.R. 589.2000) - Animal Proteins Prohibited
in Ruminant Feed. The regulation is intended to prevent the establishment and
amplification of Bovine Spongiform Encephalopathy (BSE). Because you failed to
follow this rule, products you manufactured and distributed are adulterated
within the meaning of Section 402(a)(4) of the Federal Food, Drug, and Cosmetic
Act (the Act) because they were prepared, packed, or held under insanitary
conditions whereby they may have been rendered injurious to health.
Our inspection found the following violations of 21 C.F.R. 589.2000:
1. Failure to provide for measures to avoid commingling or
cross-contamination of products that contain or may contain protein derived from
mammalian tissues into animal protein or feeds that may be used for ruminants to
comply with 21 C.F.R. 589.2000(e)(1)(iii).
* Your firm uses a vacuum system to clean up spilled product in the tunnel
area. This tunnel area houses the two receiving conveyor systems and the
elevators for the two conveyor systems. When product, including ruminant meat
and bone meal, is spilled onto the floor of this area, the spilled product is
vacuumed up by the vacuum system and, via a discharge hose, was placed into a
conveyor system that your firm had designated as free of ruminant meat and bone
meal. Your firm admitted that it was unaware of the vacuum system discharging
into the conveyor systems designated as free of ruminant meat and bone meal and
that this had been in place since April 2003. Your firm remedied this problem
during FDA s April/May 2004 inspection by removing the discharge hose connection
to the conveyer system that your firm had designated as free of ruminant meat
and bone meal . * Your firm uses a dust collection system that pulls dust from
systems that receive both ruminant meat and bone meal and feed ingredients
intended for ruminants. This dust system then discharged collected product back
into the two conveyor systems via a cross connection, thereby making it likely
that ruminant meat and bone meal became commingled with ruminant feed
ingredients. Your firm admitted that it was unaware of the cross connection and
that it had been in place since April 2003. Your firm removed the cross
connection during FDA s April/May 2004 inspection.
2. Failure to maintain written procedures specifying the clean-out
procedure or other means, and specifying the procedures for separating products
that contain or may contain protein derived from mammalian tissue from all other
protein products from the time of receipt until the time of shipment, to comply
with 21 C.F.R. 589.2000(e)(1)(iv). This observation was also noted during FDA s
July/August 2003 inspection of your firm.
* There are no written procedures for separating products that contain
prohibited material from ingredients used in ruminant feeds from the time of
receipt until the time of shipment. * The written procedure for cleaning out or
flushing equipment after mixing feeds containing prohibited material was not
adequate to prevent contamination of ruminant feed with prohibited material.
3. Failure to maintain records sufficient to track materials that contain
protein derived from mammalian tissues throughout their receipt, processing, and
distribution to comply with 21 C.F.R. 589.2000(e)(1)(i). This observation was
also noted during FDA s July/August 2003 inspection of your firm.
* Specifically, your firm has failed to develop and implement complete
written procedures to separate ruminant meat and bone meal from feed ingredients
intended for ruminants from the time of receipt until the time of distribution.
The written procedures that do exist fail to address the use of equipment common
to ruminant meat and bone meal and ruminant feed ingredients.
The above is not intended to be an all-inclusive list of deficiencies at
your facility. As a manufacturer of materials intended for use as animal feed,
you are responsible for assuring that 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 such violations do not recur. Failure to promptly correct these
violations may result in regulatory action without further notice, such as
seizure and/or injunction.
You should notify this office in writing within fifteen (15) working days
of receiving this letter of the steps you have taken to bring your firm into
compliance with the law. Your response should include an explanation of each
step being taken to correct the violations and prevent their recurrence. If
corrective actions cannot be completed in fifteen (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 that corrections
have been made.
Please send your reply to the U.S. Food and Drug Administration, Attention:
Ms. Harumi Kishida, Compliance Officer, 1431 Harbor Bay Parkway, Alameda,
California 94502-7070. If you have questions regarding this letter, please
contact Ms. Kishida at (510) 337-6824.
Sincerely,
/s/
CD Moss, Acting DD for Barbara J. Cassens District Director San Francisco
District
cc: VIA CERTIFIED MAIL RETURN RECEIPT REQUESTED C. Michael Blasco, Feed
Mill Manager Fresno Farming LLC P.O. Box 430 Traver, California 93673
Public Health Service Food and Drug Administration
Chicago District 550 West Jackson Blvd., 15th Floor Chicago, Illinois 60661
Telephone: 312-353-5863
July 12, 2004
WARNING LETTER CHI-16-04
CERTIFIED MAIL RETURN RECEIPT REQUESTED
Mr. Donald E. Hamilton, President/Owner Illini Feeds, Inc. P.O. Box 86,
1145 State Hwy. 94 Aledo, Illinois 61231
Dear Mr. Hamilton:
On February 19 and 20, 2004, the Food and Drug Administration (FDA)
conducted an inspection of your animal feed handling facility located at 1145
State Highway 94, Aledo, Illinois. The inspection found 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). The deviations cause the swine feed
manufactured by your facility to be misbranded within the meaning of Section
403(a)(1) of the Federal Food, Drug, and Cosmetic Act (the Act).
Our investigation found that salvaged pet food containing prohibited
material was added as an ingredient to the swine products manufactured at your
facility. During the inspection, our investigator found that you failed to label
your non-ruminant products with the required caution statement - Do not feed to
cattle or other ruminants. [21 CFR 589.2000(d)(1)]
The above is not intended to be an all-inclusive list of violations. As a
manufacturer of materials intended for use in animal feed, you are responsible
for assuring that your overall operation and the products you manufacture and
distribute are in compliance with the law.
You should take prompt action to correct this violation, and you should
establish a system whereby such violations do not recur. Failure to promptly
correct this violation may result in regulatory action without further notice,
such as seizure and/or injunction.
During the inspection, you told the investigator that you would put the
required cautionary statement on your products that contain prohibited material,
and maintain tracking documents for all incoming ingredients, including animal
proteins prohibited in ruminant feed. Please notify this office in writing
within 15 working days of receiving this letter of any further steps you have
taken to assure that your firm is in compliance with the law. Your response
should also include an explanation of each step taken to correct the violations,
and prevent their recurrence. Please include copies of any available
documentation such as written procedures, corrected labeling, etc.,
demonstrating that corrections have been made. If corrections cannot be
completed within 15 working days, state the reason for the delay and the date by
which the corrections will be completed.
Your reply should be directed to Paul A. Boehmer, Compliance Officer, at
the above address.
Sincerely,
/s/
Scott J. MacIntire District Director
Public Health Service Food and Drug Administration
Chicago District 550 West Jackson Blvd., 15th Floor Chicago, Illinois 60661
Telephone: 312-353-5863
June 15, 2004
WARNING LETTER
CERTIFIED MAIL RETURN RECEIPT REQUESTED
Mr. David W. Bernauer CEO and Chairman of the Board Walgreen co. 200 Wilmot
Rd. Deerfield, IL 60015
Dear Mr. Bernauer:
Inspection of your firm s warehouse at 5100 Lake Terrace N.E., Mt. Vernon,
Illinois, by the Illinois Department of Public Health and the U.S. Food and Drug
Administration (FDA) on February 25, 26, and 27, and March 2, 2004, documented
numerous insanitary conditions which caused the food and drug products stored
there to become adulterated.
Our inspection showed that the food and drug products stored and held at
your facility violated the Federal Food, Drug, and Cosmetic Act (the Act),
rendering them adulterated. These adulterated fwd and drug products: a)
consisted in whole or in part of filthy substances, including rodent fecal
pellets, rodent hair, and insects, in violation of Section 402(a)(3) of the Act
[21 U.S.C. 342(a)(3)]; and/or b) had been held under insanitary conditions
whereby they have become contaminated with rodent filth, in violation of
Sections 402(a)(4) and 501(a)(2)(a) of the Act [21 U.S.C. 342(a)(4),
351(a)(2)(a)].
Evidence of rodent activity documented throughout the old and new warehouse
included dead mice in traps, excreta pellets, and gnawed paper material observed
in, on, and near food and drugs stored in the warehouse. Rodents gnaw holes were
observed into several packaged food products with rodent hairs at gnaw holes
into products. Many more fecal pellets were on food and drug packages and still
more were found near the stored foods, drugs, and cosmetics in the warehouse.
Other conditions observed during the inspection that could be contributing
factors to rodent infestation include damaged and/or poorly fitting rail and
truck dock doors, gaps around a conduit entry into the building, and the
structural condition of the concrete and expansion gaps at floor/wall/support
beam junctions in various areas of the warehouse allowing the entry or harborage
of pests. Additionally, the investigators observed cobwebs, dead insects, dust,
debris, product spillage, and papers in the warehouse, indicating a general lack
of good sanitation practices.
Also, products that contain or may contain animal protein prohibited
ruminant feed (BSE material) failed to bear the caution statement, Do not feed
to cattle or other ruminants. Specifically, pet food products were salvaged,
repackaged, and donated to [redacted] and other similar organizations in the
area, without the proper labeling and agreement that they would not be used for
ruminants. Please refer to Title 21, Code of Federal Regulations, Section
589.2000, concerning these requirements.
Our laboratory confirmed the findings of rodent excreta, rodent hairs on
product gnaw holes, and rodent gnawed fibers (packaging material) sampled from
the warehouse during the inspection.
The above listed violations are not intended to be all-inclusive. It is
your responsibility to assure adherence with each requirement of the Act and its
implementing regulations. The investigators reported that you destroyed food
products that showed evidence of contamination and began to take some steps to
correct the insanitary conditions in your facility. We request that you take
prompt action to correct all violations.
Please provide this office, within 15 working days of receipt of this
letter, a detailed response stating the actions you plan to take and have taken
to correct and prevent the recurrence of these objectionable conditions. Provide
the time within which corrections will be completed, reasons why any corrective
action cannot be completed, and documentation to show that corrections have been
made. Failure to take prompt action to correct all violations may result in
regulatory action without further notice. Such action includes seizure and/or
injunction.
Your reply should be directed to Paul A. Boehmer, Compliance Officer, at
the Chicago District Office.
Sincerely,
/s/
Scott J. MacIntire District Director
cc: Stephen J. Lawrence, Distribution Center Manager Walgreen Co. 5100 Lake
Terrace NE Mount Vernon, IL 62864-9665
USA BSE GBR SHOULD BE GBR III, but someone dropped the ball...
TSS
######### http://mailhost-alt.rz.uni-karlsruhe.de/warc/bse-l.html
##########
-------- Original Message --------
Subject: MAD COW WARNING LETTER 700 lbs. Steer feed and 1,500 lb. Pig sow
fed Products may contain MAMMALIAN TISSUES USA
Date: Mon, 18 Oct 2004 11:32:17 –0500
From: "Terry S. Singeltary Sr."
Reply-To: Bovine Spongiform Encephalopathy
To: BSE-L@UNI-KARLSRUHE.DE
##################### Bovine Spongiform Encephalopathy
#####################
PRODUCT
a) Product is 9 Mile Steer Feed, packaged in white poly weaved bags, each
containing 100 lbs. A white label tied to the inlet of each bag with twine
identifies the product. Recall # V-187-4;
b) Product is 9 Mile Pig and Sow Feed, packaged in white poly weaved bags,
each bag containing 100 lbs. A white label tied to the inlet of each bag with
twine identifies the product. Recall # V-188-4.
CODE
The products contain no code date.
RECALLING FIRM/MANUFACTURER
Farmers Elevator, Co., Houston, OH, by telephone and letters dated
September 8, 2004. Firm initiated recall is ongoing.
REASON
Products may contain protein derived from mammalian tissues which is
prohibited in ruminant (steer) feed. FDA regulation, if the feed is intended for
non-ruminants (pigs), the bag labels must bear the statement ìDo not feed to
cattle or other ruminantsî.
VOLUME OF PRODUCT IN COMMERCE
700 lbs. Steer feed and 1,500 lb. Pig and sow fed.
DISTRIBUTION
OH.
################# BSE-L-subscribe-request@uni-karlsruhe.de
#################
-------- Original Message --------
Subject: MAD DEER FEED BAN WARNING LETTER RECALL 6 TONS DISTRIBUTED USA
Date: Wed, 20 Oct 2004 14:53:56 –0500
From: "Terry S. Singeltary Sr."
Reply-To: Bovine Spongiform Encephalopathy
To: BSE-L@UNI-KARLSRUHE.DE
##################### Bovine Spongiform Encephalopathy
#####################
PRODUCT
Product is custom made deer feed packaged in 100 lb. poly bags. The product
has no labeling. Recall # V-003-5.
CODE
The product has no lot code. All custom made feed purchased between June
24, 2004 and September 8, 2004.
RECALLING FIRM/MANUFACTURER
Farmers Elevator Co, Houston, OH, by telephone and letter dated September
27, 2004. Firm initiated recall is ongoing.
REASON
Feed may contain protein derived from mammalian tissues which is prohibited
in ruminant feed.
VOLUME OF PRODUCT IN COMMERCE
Approximately 6 tons.
DISTRIBUTION
OH.
END OF ENFORCEMENT REPORT FOR October 20, 2004
################# BSE-L-subscribe-request@uni-karlsruhe.de
#################
Public Health Service Food and Drug Administration
Seattle District Pacific Region 22201 23rd Drive SE Bothell, WA 9S9214421
Telephone: 425-486-8788 FAX: 425- 483-4996
November 18, 2004
VIA FEDEX
In reply refer to Warning Letter SEA 05-07
William B. Parrish, Chairman of the Board Parrish & Heimbecker Limited
360 Main Street Winnipeg, Manitoba, R3C 323 Canada
WARNING LETTER
Dear Mr. Parrish:
An inspection of your feed mill operation, Conway Feed, Inc., located at
18700 Main Street, Conway, Washington, conducted by a Washington State
Department of Agriculture Investigator, on June 17, 18 and 22, 2004, under
contract with the Food and Drug Administration (FDA), found significant
deviations from the requirements set forth in Title 21, Code of Fedederal
Regulations, Part 589.2000 (21 CFR 589.2000) Animal Proteins Prohibited in
Ruminant Feed. The regulation is intended to prevent the establishment and
amplification of Bovine Spongiform Encephalopathy (BSE). Such deviations cause
products being manufactured and/or distributed by this facility to be
adulterated within the meaning of Section 402(a)(4) and misbranded within the
meaning of Section 403(a) and 403(f) of the Federal Food, Drug and Cosmetic Act
(the Act).
Our investigation found that because you failed to adequately inspect the
label of a raw material, au ingredient with the cautionary statement Do Not Feed
to Cattle or Other Ruminants was used in the manufacture of your finished
product, Game Bird Crum/Pellet. Your final product, however, did not have the
cautionary statement. Because this fish meal may have contained prohibited
animal proteins, any product produced with it must have the cautionary label.
See 21 CFR 589.2000(d)(1).
The investigation also revealed that the label of your Game Bird
Crum/Pellet feed did not list fish meal as an ingredient. According to the
information we collected during the inspection fish meal is routinely added to
this ration. All ingredients are required to be listed on the label in
descending order of predominance by weight. See 21 CFR 501.4(a).
The above is not intended to be an all-inclusive list of deviations from
the regulations. As a manufacturer of materials intended for animal feed use,
you are responsible for assuring that your overall operation and the products
you manufacture and distribute are in compliance with the law. We have enclosed
a copy of the FDA s Small Entity Compliance Guide to assist you with complying
with the regulation.
You should take prompt action to correct these violations, and you should
establish a system whereby such violations do not recur. Failure to promptly
correct these violations may result in regulatory action without further notice,
such as seizure and/or injunction.
You should notify this office in writing within 15 working days of receipt
of this letter, of the steps you have taken to bring your firm into compliance
with the Iaw. Your response should include an explanation of each step being
taken to correct the violations, and prevent their recurrence. If corrective
action cannot be completed in 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 that corrections have been made.
Please send your reply to the Food and Drug Administration, Attention:
Bruce Williamson, Compliance Officer, 22201 23rd Drive SE, Bothell, Washington
98021. If you have questions regarding any issue in this letter, please contact
Mr. Bruce Williamson at (425) 483-4976.
If you have questions regarding any issue in this letter, please contact
Mr. Bruce Williamson at (425) 483-4976.
Sincerely,
/S/
Charles M. Breen District Director
cc: Scott C. McKnight, General Manager Conway Feed Inc. 18700 Main Street
Conway, WA 98238-0576
Enclosure: Form FDA 483 Small Entity Compliance Guide
-------- Original Message --------
Subject: MAD COW FEED BAN WARNING LETTER Animal Proteins Prohibited in
Ruminant Feed/Misbranded DEC. 9, 2004
Date: Tue, 21 Dec 2004 16:04:44 –0600
From: "Terry S. Singeltary Sr."
To: Bovine Spongiform Encephalopathy
CC: cjdvoice@yahoogroups.com
Public Health Service Food and Drug Administration
New Orleans District Southeast Region 6600 Plaza Drive, Suite 400 New
Orleans, Louisiana 70127 Telephone: 504-253-4519 Facsimile: 504-253-4520
December 9, 2004
WARNING LETTER NO. 2005-NOL-07
FEDERAL EXPRESS OVERNIGHT DELIVERY
Mr. Alan O. Bostick, President Sunshine Mills, Inc. 500 6th Street SW Red
Bay, Alabama 35582
Dear Mr. Bostick:
On September 7 and 14, 2004, a United States Food and Drug Administration
(FDA) investigator inspected your animal feed manufacturing facility, located at
2103 South Gloster Street, Tupelo, Mississippi. 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. The regulation is intended to prevent the
establishment and amplification of Bovine Spongiform Encephalopathy (BSE).
Because you failed to follow the requirements of this regulation, products you
manufactured and/or distributed are misbranded within the meaning of Section
403(a)(1) of the Federal Food, Drug, and Cosmetic Act (the Act).
The inspection indicated you manufacture products containing beef meat and
bone meal. Products that contain or may contain protein derived from mammalian
tissues, as defined by 21 CFR 589.2000(a), and are intended for use in animal
feed, must be labeled with the cautionary statement Do not feed to cattle or
other ruminants. This is required by 21 CFR 589.2000(c)(1)(i). Your firm failed
to label your non-ruminant products with this required cautionary statement.
Specifically, the products that contained protein derived from mammalian tissues
but lacked the required statement included your Happy Fisherman and Premier
catfish feeds. Under 21 CFR 589.2000(g)(2), failure of these feeds to bear the
required cautionary statement causes them to be misbranded under Section
403(a)(1) of the Act.
The above is not intended to be an all-inclusive list of deviations from
regulations. As a manufacturer of materials intended for animal feed use, you
are responsible for assuring your overall operation and products you manufacture
and distribute are in compliance with the law. A copy of FDA s Small Entity
Compliance Guide is enclosed to assist you in complying with the regulations.
You should take prompt action to correct these violations and establish a
system whereby such violations do not recur. Failure to promptly correct these
violations may result in regulatory action, such as seizure and/or injunction,
without further notice.
We are aware you sent label corrections for the last shipment of each of
the mislabeled products. You also stated you plan [redacted] However, you should
notify this office in writing, within 15 working days of the receipt of this
letter, of the 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
violations and prevent their recurrence. If corrective action cannot be
completed within 15 working days, state the reason for delay and date by which
corrections will be completed. Include copies of any available documentation
demonstrating corrections have been made.
Please send your reply to the U.S. Food and Drug Administration, Attention:
Nicole F. Hardin, Compliance Officer, at the above address. If you have
questions regarding any issue in this letter, please contact Ms. Hardin at (504)
253-4519.
Sincerely,
/s
H. Tyler Thornburg District Director New Orleans District
Enclosures: FDA Form 483 FDA s Small Entity Compliance Guide 21 CFR
589.2000
cc: [redacted] General Manager Sunshine Mills, Inc. 2103 South Gloster
Street Tupelo, Mississippi 38801
TSS
2003
-------- Original Message --------
Subject: MAD COW FEED BAN WARNING LETTER Animal Proteins Prohibited in
Ruminant Feed/Misbranded
Date: Tue, 23 Sep 2003 15:46:19 –0500
From: "Terry S. Singeltary Sr."
Reply-To: Bovine Spongiform Encephalopathy
To: BSE-L@uni-karlsruhe.de
Public Health Service Food and Drug Administration
DEPARTMENT OF HEALTH & HUMAN SERVICES Food and Drug Administration
Chicago DiStriCt 550 West Jackson Blvd., 15th Floor
August 25,2003
Chicago, Illinois 60661
Telephone: 312-353-5863 WARNING LETTER CH-19-03 CERTIFIED MAIL RETURN
RECEIPT REQUESTED
William H. Jenner, President Lincoln Land Livestock Co., Inc. 436 South
Railway Ave. Maswutah, Illinois 62258
Dear Mr. Jenner: On April 14 and 15,2003, the Food and Drug Administration
(FDA) conducted an inspection at your animal feed handling facility at 436 South
Railway Ave., Mascoutah, Illinois, that, among other things. operates as an own
label distributor of Hot Line brand feeds made for you by The inspection found
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). Such deviations cause products being
handled by your facility to be misbranded within the meaning of Section
403(a)(l) of the Federal Food, Drug, and Cosmetic Act (the Act). The inspection
also found significant deviations from the requirements set forth in 21 CFR 501
- Animal Food Labeling. Our investigator found the following violations during
the inspection: Products that contain or may contain prohibited material fail to
bear the caution statement - Do not feed to cattle or other ruminants as
required by 21 CFR 589.2OOO(c)( l)(i). Specifically, your firm is responsible
for preparing the formulations and labeling for Lincoln Land labeled products
and some of the products lack the above required cautionary statement. Product
ingredients are not listed on the label of the product Hotline Sow 100 by common
or usual name in descending order of predominance by weight as required by 21
CFR 501.4. Also, the ingredient list on the label does not reflect all the
ingredients.
Page 2 During the inspection FDA s investigator also found that you did not
maintain written clean-out procedures to prevent carryover of protein derived
fi-om mammalian tissues to animal protein or feeds that may be used for
ruminants. You had no written procedures that describe the steps used to clean
your truck after hauling bulk meat and bone meal. 21 CFR 589.2000 requires
maintenance of written clean-out procedures. The above is not intended to be an
all-inclusive list of violations. While you handle the animal feed label and
distribution operations, the products man are directed, through contract
arrangement with the above mentioned Your firm, as the handler and labeler of
materials intended for animal feed use, is responsible for controlling your part
of the operation to ensure that the products manufactured are in compliance with
the law. You should take prompt action to correct all of these violations, and
you should establish a system whereby such violations do not recur. Failure to
promptly correct these violations may result in regulatory action without
further notice, such as seizure, and/or injunction. Please provide this office
within 15 working days of receipt of this letter the 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. Please include copies of any available documentation such as written
procedures, corrected labeling, etc. demonstrating that corrections have been
made. If corrections cannot be completed within 15 working days, state the
reason for the delay and the date by which the corrections will be completed.
Your reply should be directed to Paul A. Boehmer, Compliance Officer, at the
above letterhead address. Sincerely, \s\ Arlyn H. Baumgarten District Director
Subject: MAD COW FEED BAN WARNING LETTER (disguised as medicated feed
warning letter)
Date: Tue, 1 Apr 2003 08:39:26 –0600
From: "Terry S. Singeltary Sr."
Reply-To: Bovine Spongiform Encephalopathy
To: BSE-L@uni-karlsruhe.de
######## Bovine Spongiform Encephalopathy #########
Food and Drug Administration Cincinnati District Office Central Region 6751
Steger Drive Cincinnati, OH 45237-3097 Telephone: (513) 679-2700 FAX: (513)
679-2771
March 4, 2003
WARNING LETTER CIN-03-16534 FedEx
William E. Leininger, Director of Operations Buckeye Egg Farm L.P. 11212
Croton Road Croton, OH 43013
Dear Mr. Leininger:
An inspection of your medicated feed mill located at 10750 Croton Road,
Croton, OH 43013, conducted by Food and Drug Administration investigators, on
1/27, 30/2003, found significant deviations from Current Good Manufacturing
Practice (CGMP) regulations for Medicated Feeds (Title 21 CODE OF FEDERAL
REGULATIONS, Part 225). Such deviations cause feeds being manufactured at this
facility to be adulterated within the meaning of section 501(a)(2)(B) of the
Federal Food, Drug, and Cosmetic Act.
Our investigation found:
1. failure to conduct potency assays on at least three representative
samples of each feed required to be manufactured by a licensed feed mill at
periodic intervals during the calendar year [21 CFR 225.58(b)(1); 2. failure to
maintain a daily inventory record for each drug used [21 CFR 225.42(b)(7)]; 3.
failure to calibrate scales and metering devices at least once a year to insure
their accuracy [21 CFR 225,30(b)(4)]; 4. failure to properly identify drugs in
the mixing area to maintain their integrity and identity [21 CFR 225.42(b)(4);
5. failure to use all Type B medicated feed articles in accordance with labeled
mixing directions [21 CFR 225.142]; 6. failure to have a qualified person check,
date, and sign or initial each Master Record File [21 CFR 225.102(b)(l); 7.
failure to identify medicated feed with appropriate labeling which, if adhered
to, will assure the article is safe and effective for its intended purpose [21
CFR 225.80(a)].
In addition to the, deviations described above, our investigators found
that your products, which contain or may contain prohibited materials, fail to
bear the caution statement: "Do not feed to cattle or other ruminants", as
required by 21 CFR 589.2000(d). This causes your medicated feed to be misbranded
within the meaning of section 403(a)(1) of the Federal Food, Drug, and Cosmetic
Act.
Your firm has also failed to maintain a current Drug Establishment
Registration in that your registration expired in April 2001. This causes your
medicated feed to be misbranded within the meaning of section 502(o) of the
Federal Food, Drug, and Cosmetic Act.
The above is not intended as an all-inclusive list of CGMP violations. As a
manufacturer of medicated and non-medicated feeds, you are responsible for
assuring that your overall operation and the products you manufacture and
distribute are in compliance with the law.
You should take prompt action to correct these CGMP violations, and you
should establish procedures whereby such violations do not recur. Failure to
promptly correct these CGMP violations may result in regulatory and/or
administrative sanctions. These sanctions include, but are not limited to,
seizure, injunction, and/or notice of opportunity for a hearing on a proposal to
withdraw approval of your Medicated Feed Mill License under section
512(m)(4)(B)(ii) of the Act and 21 CFR 515.22(c)(2). This letter constitutes
official notice under the law of CGMP violations. Based on the results of the
01/27, 30/2003 inspection, the methods used in, or the facilities and controls
used for, the manufacture, processing, and packing of medicated feeds are
inadequate to assure and preserve the identity, strength, quality, and purity of
the new animal drugs therein. This letter notifies you of our findings and
provides you an opportunity to correct the above deficiencies.
You should notify this office, in writing, within fifteen (15) working days
of the receipt of this letter of the steps you have taken to bring your firm
into compliance with the law. Your response should include an explanation of
each step being taken to correct the CGMP violations and prevent their
recurrence. If corrective action cannot be completed within 30 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 that
corrections have been made.
Your response should be directed to Charles S. Price Compliance Officer,
U.S. Food and Drug Administration, 6751 Steger Drive, Cincinnati, OH 45237-3097.
If you have any questions regarding this letter, you may call Mr. Price at
telephone (513) 679-2700 extension 165.
Sincerely,
/s/
Carol A. Heppe,
District Director
Cincinnati District
>In addition to the, deviations described above, our investigators found
that your products, which contain or may contain prohibited materials, fail to
bear the caution statement: "Do not feed to cattle or other ruminants", as
required by 21 CFR 589.2000(d). This causes your medicated feed to be misbranded
within the meaning of section 403(a)(1) of the Federal Food, Drug, and Cosmetic
Act.<
Greetings list members,
it would seem to me this should have been a separate warning letter on the
issues of 21 CFR 589.2000(d) and not hidden and imbedded in a warning letter
with the title;
Lacks Ruminant Caution/Medicated Feeds/Adulterated/Misbranded
opposed to past titles;
Animal Proteins Prohibited in Ruminant Feed/Adulterated
nice try;-)
TSS
########### http://mailhost.rz.uni-karlsruhe.de/warc/bse-l.html
############
-------- Original Message --------
Subject: 517,990 LBS. OF RUMINANT PROTEIN IN CATTLE FEED DISTRIBUTED AND
MORE ...
Date: Tue, 29 Apr 2003 11:21:52 -0500 From: "Terry S. Singeltary Sr."
Reply-To: Bovine Spongiform Encephalopathy To: BSE-L@uni-karlsruhe.de
RECALLS AND FIELD CORRECTIONS: VETERINARY MEDICINE - CLASS II
______________________________
PRODUCT Unlabeled bulk "Cattle Feed" sold by weight to user/farmers who
pick it up at the firm. Product is a ruminant feed used to feed beef cattle.
Recall # V-046-3. CODE Product is bulk and uncoded. RECALLING FIRM/MANUFACTURER
Zephyr Feed Company, Zephyrhills, FL., by letters on March 19, 2003 and March
26, 2003. FDA initiated recall is ongoing.
REASON Cattle feed was distributed to farmers that may contain prohibited
protein for ruminants.
VOLUME OF PRODUCT IN COMMERCE 517,990 lbs. DISTRIBUTION FL.
RECALLS AND FIELD CORRECTIONS: VETERINARY MEDICINE--CLASS II
_____________________________
PRODUCT Red Rooster Booster, Super Gallo (brand), 60 capsules. Recall #
V-011-3. CODE All codes. RECALLING FIRM/MANUFACTURER Thomas Laboratories,
Tolleson, AZ, by letters on or about November 8, 2002. State initiated recall is
ongoing.
REASON Is not labeled "Do not feed to cattle or other ruminants" and
contains a bovine tissue derivative.
VOLUME OF PRODUCT IN COMMERCE Unknown.
DISTRIBUTION Nationwide.
_____________________________
PRODUCT CATTLE FEED, Flock #999, Date: 12/5/02, Quantity 8000, Load A, Feed
C205, Grower# Z001, Tag C100. Recall # V-012-3. CODE C-205, C-210, C-220, C-302,
C-406 and all other codes manufactured and distributed by Grove River Mills,
Inc., RECALLING FIRM/MANUFACTURER Grove River Mills Inc., Pendergrass, GA, by
telephone and letter on December 9, 2002. Firm initiated recall is ongoing.
REASON Cattle Feed contaminated with prohibited materials.
VOLUME OF PRODUCT IN COMMERCE 235,668 lbs. DISTRIBUTION GA.
END OF ENFORCEMENT REPORT FOR FEBRUARY 5, 2003
another description here;
FEBRUARY 2003
PRODUCT Red Rooster Booster, Super Gallo (brand), 60 capsules.
CODE All codes. RECALLING FIRM/MANUFACTURER Thomas Laboratories, Tolleson,
AZ,
REASON Is not labeled "Do not feed to cattle or other ruminants" and
contains a bovine tissue derivative. VOLUME OF PRODUCT IN COMMERCE Unknown.
DISTRIBUTION Nationwide.
PRODUCT CATTLE FEED, Flock #999, Date: 12/5/02, Quantity 8000, Load A, Feed
C205, Grower# Z001, Tag C100.
CODE C-205, C-210, C-220, C-302, C-406 and all other codes manufactured and
distributed by Grove River Mills, Inc., RECALLING FIRM/MANUFACTURER Grove River
Mills Inc., Pendergrass, GA,
REASON Cattle Feed contaminated with prohibited materials.
VOLUME OF PRODUCT IN COMMERCE 235,668 lbs. DISTRIBUTION GA.
Red Rooster Booster - 60 Capsules $7.95 210-4610-C03
Concentrated nutritional supplement for body building gamebirds.
interesting; Bone Meal with D3 - 25 lb. Powder $69.95 520-0210-P09
hell, no wonder humans are becoming resistant to antibiotics;
Fish Cillin (Ampicillin) 250mg - 30 Capsules
$11.95 00-10136-C01 Thomas Labs
Fish Cillin (Ampicillin) 250mg - 100 Capsules
$29.95 00-10136-C03 Thomas Labs
Fish Cycline (Tetracycline) 250mg - 30 Capsules
$7.95 00-10132-C01 Thomas Labs
Fish Cycline (Tetracycline) 250mg - 100 Capsules
$15.95 00-10132-C03 Thomas Labs
Fish Flex (Cephalexin) 250mg - 30 Capsules
$15.95 00-12136-C01 Thomas Labs
Fish Flex (Cephalexin) 250mg - 60 Capsules
$29.95 00-12138-C02 Thomas Labs
Fish Flex (Cephalexin) 250mg - 100 Capsules
$39.95 00-12138-C03 Thomas Labs
Fish Fungus (Ketoconazole) 200 mg - 30 Tablets
$39.95 00-0024-T01 Thomas Labs
Fish Mox (Amoxicillin) 250mg - 30 Capsules
$7.95 00-10131-C01 Thomas Labs
Fish Mox (Amoxicillin) 250mg - 100 Capsules
$15.95 00-10131-C03 Thomas Labs
Fish Mycin (Erythromycin) 250mg - 30 Tablets
$15.95 00-10902-T01 Thomas Labs
Fish Mycin (Erythromycin) 250mg - 100 Tablets
$29.95 00-10902-T03 Thomas Labs
Terramycin TM-20 - 8 oz. Powder
wonder if these mycin's are any relative of the VANCOMYCIN ???
http://www.thomasveterinarydrug.com/mailorder/catalog/default.php?manufacturers_id=11&sort=1a&page=4
TSS
-------- Original Message --------
Subject: Re: MAD COW FEED BAN WARNING LETTER USA (a real hum dinger)
!
Date: Tue, 24 Jun 2003 16:59:41 -0500
From: "Terry S. Singeltary Sr."
To: Bovine Spongiform Encephalopathy
References: 3EE5D269.9040504@wt.net
i hate to keep kicking a mad cow here, but i thought since the FDA et al
still refuses to tell us about _all_ the ruminant-to-ruminant feed ban
violations, i thought i would go over a few of the old ones i might have missed.
BOY, did i miss one. has all this feed been confirmed to have been recalled? how
much is still out there?
RECALLS AND FIELD CORRECTIONS: VETMED -- CLASS II
________
PRODUCT & CODES:
Animal feed products, packaged in 5, 25, 50, and 55 pound bags, and in
bulk,
intended for both ruminant and non-ruminant animals. The products are as
follows:
Recall # V-195-1 through V-350-1.
RUMINANT FEED PRODUCTS:
RECALL NO. PRODUCT NO. PRODUCT NAME
V-195-1 40150 B. 30% Calf Pellet
V-196-1 40250 B. 16% Calf Pellet
V-197-1 40350 B. 16% Calf Ration
V-198-1 40450 B. 18% Calf Starter
V-199-1 40600 B. 38% Dairy Pellet
V-200-1 40650 B. 38% Dairy Pellet
V-201-1 40750 B. 16% Dairy Feed
V-202-1 40950 B. 40% Beef Pellet
V-203-1 41150 B. 18% Lamb Starter Pellet
V-204-1 41250 B. 39% Lamb Conc. Pellet
V-205-1 41350 B. 14% Lamb & Beef Pellet
V-206-1 41450 B. 16% Goat Feed
V-207-1 42150 B. 32% Expectation Pellet
V-208-1 42250 B. Llama & Alpaca Pellet
V-209-1 42350 B. 32% Calf Grower Pellet
V-210-1 42650 B. Llama & Alpaca Crums
V-211-1 42750 B. 38% Hay Booster 2
V-212-1 42850 B. 25% Pasture Booster
V-213-1 43100 B. 16% Grower/Dev Pellet
V-214-1 43150 B. 16% Grower/Dev Pellet
V-215-1 43700 WH 32% Calf Gro Pellet
V-216-1 43750 WH 32% Calf Gro Pellet
V-217-1 43850 B. 38% Dairy Mix
V-218-1 44250 B. 17% Doe Pellet
V-219-1 44350 B. 21% Buck Pellet
V-220-1 44450 Legends Ranch Pellet
V-221-1 44500 Legends 17% Breeder Pellet
V-222-1 1652 B. Vitamin E-20
V-223-1 1614 B. Vitamin A-30
V-224-1 44550 Legends 17% Breeder Pellet
V-225-1 44650 Legends 13.5% Rut Pellet
V-226-1 44750 Deer Starter (J)
V-227-1 44940 Llama Premix (J) FSC
V-228-1 45150 Empire 25% Calf Pellet
V-229-1 45450 Berry Llama Pellet
V-230-1 45950 50% Beef Conc. (Meal)
V-231-1 46250 B. 12% Sweet Livestock
V-232-1 46350 B. 1440 Bovatec Pellet
V-233-1 46400 Liberty 38% Dairy Pellet
V-234-1 46450 Liberty 38% Dairy Pellet
V-235-1 47150 B. 14% Gold-n-Grower
V-236-1 47250 B. 12% Gold-n-Conditioner
V-237-1 47450 B. 18% Gold-n-Lamb
V-238-1 47800 Homeworth Dairy Pellet
V-239-1 47850 Homeworth Dairy Pellet
V-240-1 47900 B. 36% Hi Fat Dairy Pellet
V-241-1 47950 B. 36% Hi Fat Dairy Pellet
V-242-1 48550 B. 16% Calf Pellet CA
V-243-1 49200 Mastead Dairy Base
V-244-1 49300 KLEJKA Dairy Base
V-245-1 49650 Deer Premix (J) HFB
V-246-1 49750 39% Lamb Premix (J) HFB
V-247-1 49850 Lamb Starter Premix (J) HFB
V-248-1 120850 Brood Cow Deluxe Mineral
V-249-1 152850 B. A-D-E Mix
NON-RUMINANT FEED PRODUCTS:
V-250-1 10150 B. Miracle Starter
V-251-1 10350 B. 21% Broiler Starter
V-252-1 10450 B. Pullet Grower & Developer
V-253-1 10550 B. 18% Layer Breeder Pellets
V-254-1 10750 B. 20% Gold Std. Laying Crum
V-255-1 10950 B. 17% Complete Laying Crums
V-256-1 11050 B. 16% Prosperity Layer Crums
V-257-1 11100 B. 40% Poultry Concentrate
V-258-1 11150 B. 40% Poultry Concentrate
V-259-1 11250 B. 28% Turkey Starter Crums
V-260-1 11350 20% Gig "4" Pellets
V-261-1 11450 B. 16% Prosperity Layer Pellets
V-262-1 11550 18% Game Bird Breeder Pellets
V-263-1 11650 B. 19% Ratite Grower Diet
V-264-1 11750 B. 23% Ratite Breeder Diet
V-265-1 12100 B. 40% Poultry Concentrate Crums
V-266-1 12550 B. 32% Base Poultry Mix
V-267-1 13250 B. 28% Turkey Starter
V-268-1 13450 B. 20% Poultry Grower
V-269-1 14325 B. Game Bird Mix - Coarse
V-270-1 20150 B. 18% Pig Starter Pellets
V-271-1 20250 B. 16% Pig Grower Pellets
V-272-1 20450 B. 14% Porkmaker 100 Pellets
V-273-1 20550 B. 40% Gro 'Em Lean
V-274-1 21850 B. 27% Hi-Fat Swine Base
V-275-1 23000 Mt. Hope Hevy Hog
V-276-1 30050 12% Pleasure Horse - Sweet
V-277-1 30150 Alfa + Performer 10 Sweet
V-278-1 30250 14% Grass + Perf Sweet
V-279-1 30450 12% Wrangler - Complete
V-280-1 30550 B. 12% Pleasure Horse Pellets
V-281-1 30650 B. 32% Gro' N Win Pellets
V-282-1 30750 12% Wrangler Cubes
V-283-1 30950 18% Foal Starter
V-284-1 31050 B. 14% Alfa + Dev Pellets
V-285-1 31150 B. Alfa + Performer 10 Pel
V-286-1 31200 Grass +Performer 14 Pel
V-287-1 31250 Grass +Performer 14 Pel
V-288-1 31350 12% Mustang
V-289-1 31450 Endurance - 101 Extruded
V-290-1 31550 B. Equine Energy - UK
V-291-1 31650 B. 16% Grass + Dev Pellets
V-292-1 31750 16% Grass + Dev Cubes
V-293-1 31850 16% Grass + Dev Sweet
V-294-1 31950 B. 11% Alfa Gro 'N Win Pel
V-295-1 32050 B. Sho' Win Pellets
V-296-1 32250 B. Senior Formula
V-297-1 32350 Oscar Horse Mix
V-298-1 32450 B. Ultimate Finish
V-299-1 32550 Crossfire Horse Feed
V-300-1 32650 B. Equine 16% Growth
V-301-1 32750 B. Reduced Energy Formula
V-302-1 32850 B. Training Formula
V-303-1 32950 B. Cadence Formula
V-304-1 33150 B. Track 12 Horse Feed
V-305-1 33350 Spears 16% GR + Dev Cubes
V-306-1 33400 B. 14% Supreme Horse Pellets
V-307-1 33450 B. 14% Supreme Horse Pellets
V-308-1 33650 B. Race'N Win
V-309-1 33750 B. 14% Prominent Horse Feed
V-310-1 33850 B. Unbeetable Horse Feed
V-311-1 34750 Cargill Senior Horse
V-312-1 34850 Cargill Vitality Gold
V-313-1 35150 Chagrin 12% Sweet Fd
V-314-1 35250 Smith Pure Pleasure
V-315-1 35750 Roundup 10% Horse Pellets
V-316-1 35850 12% Summerglo Horse
V-317-1 36255 B. Grass +Min&VitBase - Mexico
V-318-1 36850 Miller's 12% Horse Feed
V-319-1 37155 B. Gro'Win Base Mix - Mexico
V-320-1 38000 B. 32% Premium Mixer Pellets
V-321-1 38050 B. 32% Premium Mixer Pellets
V-322-1 38100 36% Maintenance Mixer Pellets
V-323-1 38150 36% Maintenance Mixer Pellets
V-324-1 50150 Terramycin Crumbles
V-325-1 60105 16% Rabbit Pellets
V-326-1 60125 16% Rabbit Pellets
V-327-1 60150 B. 16% Rabbit Pellets
V-328-1 60205 18% Rabbit Developer
V-329-1 60250 B. 18% Rabbit Developer
V-330-1 60450 B. 16% Rabbit Maintenance
V-331-1 90150 B. Buckeye Scratch
V-332-1 90225 Gold Standard Scratch
V-333-1 90250 Gold Standard Scratch
V-334-1 90350 Intermediate Scratch
V-335-1 90450 B. Chick Grains
V-336-1 90525 B. Shelled Corn
V-337-1 90550 B. Shelled Corn
V-338-1 90650 B. Cracked Corn
V-339-1 90825 B. Fine Cracked Corn
V-340-1 90850 B. Fine Cracked Corn
V-341-1 91000 Steam Flaked Corn
V-342-1 91050 Steam Flaked Corn
V-343-1 91750 Oats - HP Crimped
V-344-1 91850 B. HP Sweet Crimped Oats
V-345-1 95550 Land O' Lakes Shelled Corn
V-346-1 95650 Land O' Cracked Corn
V-347-1 95850 Land O' Lakes Chick Crack
V-348-1 100850 B. Alfalfa Pellets
V-349-1 101850 Cooked Full Fat Soybean
V-350-1 122200 Magnatone M-4-B Pels Bulk
MANUFACTURER:
Buckeye Feed Mills, Dalton, Ohio.
RECALLED BY:
Manufacturer visited local customers on April 17, 2001. On April 18 and 19,
2001, manufacturer mailed and faxed recall notices. Firm initiated recall is
ongoing.
DISTRIBUTION:
Al, CT, DE, FL, GA, IL, IN, IA, KY, ME, MD, MA, MO, MN, MS, NH, NJ, NY, NC,
OH, OR, PA, RI, TN, VA, WV, and WI.
QUANTITY:
2,790 tons of ruminant feed products and 14,000 tons of non-ruminant feed
products.
REASON:
The animal feed products may contain protein derived from mammalian
tissues.
snip...
END OF ENFORCEMENT REPORT FOR June 6, 2001.
wish someone would give us that update they were speaking of a year or so
ago;
Database Change
IMPORTANT: After March 11, 2002, FDA discontinued the database that was
used to compile these listings. The Agency started a new database on April 15,
2002, and future updates on BSE enforcement and inspectional findings will draw
from it. The format of the information presented here may change, due to design
changes of the new database. The site was to be updated after a period of time
to allow for transition into the new database system. Please note that the
information presently available below is outdated. This site will be updated
very shortly.
i guess figuring the time period on the reply from the FOIA request of
being about a year or so, and still no results, why should this surprise me?
USA/CANADA/MEXICO BSE GBR SHOULD BE CHANGED TO BSE GBR III ASAP!
Subject: Re: MAD COW FEED BAN WARNING LETTER USA (FLOATING CATFISH FOOD MAY
2003) !
Date: June 24, 2003 at 8:03 pm PST
In Reply to: Re: MAD COW FEED BAN WARNING LETTER USA (a real hum dinger) !
posted by TSS on June 24, 2003 at 3:07 pm:
RECALLS AND FIELD CORRECTIONS: VETERINARY MEDICINE -- CLASS II
______________________________
PRODUCT
Consolidated Nutrition 32 % Floating Catfish Food, packaged in 50-lb bags.
Recall # V-100-3.
CODE
Best By MAR 25 04; and Best By APR 16 04, The codes are ink-jetted on the
bags.
RECALLING FIRM/MANUFACTURER
Doane Pet Care Company, Inc., Washington Courthouse, OH, by telephone and
letter on April 16, 2003 and April 17, 2003. FDA initiated recall is
ongoing.
REASON
The fish feed product lacks the required BSE warning statement, and the
nutritional ingredient statement on the label.
VOLUME OF PRODUCT IN COMMERCE
210/50 lb bags.
DISTRIBUTION
OH, PA, and MI.
END OF ENFORCEMENT REPORT FOR MAY 21, 2003
-------- Original Message --------
Subject: MAD COW FEED BAN WARNING LETTER USA (a real hum dinger) !
Date: Tue, 10 Jun 2003 07:43:21 –0500
From: "Terry S. Singeltary Sr."
CC: CJDvoice , bloodcjd@yahoogroups.com
Public Health Service Food and Drug Administration
New Orleano District Nashville Branch Office Plus Park Blvd. Nashville, TN
37217 Tel: 615-781-6388 FAX: 615-781-6383
May 22, 2003
VIA FEDERAL EXPRESS OVERNIGHT DELIVERY
Mr. John F. Turner, Owner, Manager Millstone Agri Distributors 3721 E.
Lamar Alexander Highway Maryville, TN 37804
Warning Letter No 03-NSV-16
Dear Mr. Turner:
An inspection of your animal feed manufacturing operation, located at
Maryville, Tennessee conducted by a U.S. Food and Drug Administration
investigator on February 13, 2003, found significant deviations from the
requirements set forth in Title 21, Code of Federal Regulations (21 CFR.), Part
589.2000 - Animal Proteins Prohibited in Ruminant Feed. The regulation is
intended to prevent the establishment and amplification of Bovine Spongiform
Encephalopathy (BSE). Because you failed to follow this rule, products you
manufactured and distributed are adulterated within the meaning of Sections
402(a)(2)(C) and 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act)
since they contain an unsafe food additive and were prepared, packed, or held
under insanitary conditions . . . whereby [they] may have been rendered
injurious to health. Feed you manuf~tured also was misbranded within the
meaning of Section 403(a)(1) of the Act because of your failure to follow this
rule.
Our investigation found the following violations of 21 C.F.R. 589.2000:
1. Failure to separate the receipt, processing, and storage of products
containing prohibited material from products not containing prohibited material
[21 C.F.R. 589.2000(e)(1)(iv)];
2. Failure to establish written procedures, including clean-out and
flushing procedures, to avoid commingling and cross-contamination of common
equipment [21 C.F.R. 589.2000(e)(1)(iii)(B)];
3. Failure to maintain records sufficient to track prohibited materials
throughout the receipt, processing, and distribution of your products [21 C.F.R.
589.2000(c)(1)(ii)];
4. Failure to provide for measures to avoid commingling or
cross-contamination of feeds intended for ruminants and feeds intended for
nonruminants that may contain prohibited materials [21 C.F.R.
589.2000(c)(1)(iii)]. Specifically, our investigation found that the ruminant
product 10% Beef Conditioned was formulated primarily with screenings and
fines derived from previously manufactured non-ruminant products, Premium
Rooster Kicker in particular, that contain or may contain prohibited material.
Such deviations cause the ruminant product 10% Beef Conditioner being
manufactured at this facility to be adulterated within the meaning of Sections
402(a)(2)(C) and 402(a)(4) of the Act;
5. Failure to label your non-ruminant products with the required cautionary
statement Do not Feed to Cattle or Other Ruminants [21 C.F.R.
589.2000(c)(1)(ii)]. Our investigation specifically found that dog food
containing prohibited material was added as an ingredient to your product
Premium Rooster Kicker. The failure of these feeds to bear the required BSE
warning statement causes them to be misbranded within the meaning of Section
403(f) of the Act.
The above is not intended to be an all-inclusive list of deviations from
the regulations. As a manufacturer of materials intended for animal feed use,
you are responsible for assuring that your overall operation and the products
you manufacture and distribute are in compliance with the law. We have enclosed
a copy of the FDA s Small Entity Compliance Guide to assist you with complying
with the regulations.
You should take prompt action to correct these violations, and you should
establish a system whereby such violations do not recur. Failure to promptly
correct these violations may result in regulatory action without further notice,
such as seizure and/or injunction. You should notify this office in writing
within 15 working days of receipt of this letter of the steps you have taken to
bring your iirm into compliance with the law. Your response should include an
explanation of each step being taken to correct the violations, and prevent
their recurrence. If corrective action cannot be completed in 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 that
corrections have been made.
Your reply should be directed to the attention of Joseph E. Hayes,
Compliance Officer, U.S. Food and Drug Administration, 297 Plus Park Boulevard,
Nashville, TN 37217.
Sincerely,
/s/ Carl E. Draper Director, New Orleans District Office
Subject: Re: USA ruminant-to-ruminant feed ban warning letters ??? (All the
President's yes-men?)
Date: Wed, 29 Jan 2003 15:32:22 –0600
From: "Terry S. Singeltary Sr."
Reply-To: Bovine Spongiform Encephalopathy
To: BSE-L@uni-karlsruhe.de References: <3e21c7b9 .8040309=".8040309" wt.net="wt.net">
######## Bovine Spongiform Encephalopathy #########
Nature 421, 459 (2003); doi:10.1038/421459a
All the President's yes-men?
George W. Bush's administration stands accused of biasing the process by
which the US government obtains scientific advice. There is a strong case to
answer, but the situation is not as unusual as it might at first seem.
The relationship between science and politics is never perfect, but critics
charge that the current US administration has so politicized the provision of
scientific advice that it could permanently undermine public trust.
Just last week, a storm of protest greeted the announcement that Jerry
Thacker, an HIV-positive Christian activist who has referred to AIDS as a "gay
plague", would be appointed to the Presidential Advisory Commission on HIV and
AIDS. Three months before, a committee advising the Department of Health and
Human Services on protecting volunteers in clinical trials was asked to consider
whether embryos should be included within its remit (see Nature 420, 3–4; 2002)
— a move that critics saw as part of a wider anti-abortion agenda.
The controversy extends to committees that review grant applications.
Potential appointees to the panel advising the National Institute for
Occupational Safety and Health, for instance, were asked their views on office
safety standards — just one example, critics allege, of political considerations
impinging on appointments that should depend on scientific merit. The fear is
that scientists will refuse to serve on panels that are seen as rubber stamps
for administration policies, undermining the quality of the advice given to
government agencies and eroding public trust.
Some of the recent developments are disturbing. If the committee on human
research subjects gets bogged down discussing abortion politics instead of how
to protect patients in clinical trials, lives could be put at risk. Members of
committees reviewing grant applications should be selected for their scientific
expertise, not their political views.
But successive US administrations, both Republican and Democrat, have
packed advisory committees with scientists and other experts who share their
political outlook. This only becomes a major issue for the scientific community
when the views in question jar with its majority opinion, or the politicization
is blatant.
Those with long memories say that the present outcry is reminiscent of the
furore inspired by Ronald Reagan's administration in the early 1980s, when it
tried similar tactics with committees advising the Environmental Protection
Agency — then seen as a thorn in the side of the administration's pro-business
policies. This sorry episode alienated environmental scientists, but thankfully
the administration eventually backed off and most of the damage was repaired.
There is some comfort to be gained from the checks and balances inherent to
the system. The degree of transparency in the formulation of science-led policy
in the United States has few parallels in the rest of the world. It is rare
indeed for the public to be able to influence government decisions about who
sits on the panels and what they discuss. And so far, public input seems to be
having a positive effect — last week's storm led Thacker to withdraw from the
HIV panel.
This does not mean that the critics should relax. They should look back at
the actions of previous administrations to determine the extent to which the
current moves represent a departure from accepted practice. The National
Academies' Committee on Science, Engineering, and Public Policy is set to take
up these questions at its next meeting on 19 February, providing a welcome and
timely forum.
Scientists should fight undue attempts by the Bush administration to
politicize the advisory process, and extend the same scrutiny to future
administrations, whatever their political persuasion.
Macmillan MagazinesNature © Macmillan Publishers Ltd 2003 Registered No.
785998 England.
Greetings list members,
< This does not mean that the critics should relax.
o.k., i'm not relaxing and i want _all_ my ruminant-to-ruminant aka mad cow
feed ban violations since May 2002 to date, not just that token one from Texas i
posted today, that they let slip by for whatever reason...
Food and Drug Administration Dallas District 4040 North Central Expressway
Dallas, Texas 75204-3145
November 7, 2002
Re: 2003-DAL-WL- 05 WARNING LETTER CERTIFIED MAIL RETURN RECIEPT REQUESTED
Mr. Ronald A. Christensen President & General Manager Sunnymead Ranch,
Inc. Rt. 1, Box 49 Idalou, TX 79329
Dear Mr. Christensen:
An inspection of your feed mill located at Route 1, Idalou, Texas, was
conducted by Food and Drug Administration (FDA) Investigator Lisa Yoder on
September 9/11, 2002. The inspection found significant deviations from the
requirements set forth in Title 21, Code of Federal Regulations, Part 589.2000 -
Animal Proteins Prohibited in Ruminant Feed (21 C.F.R. 589.2000). This
regulation is intended to prevent the establishment and amplification of Bovine
Spongiform Encephalopathy (BSE). The deviations cause the feed for sheep (a
ruminant animal) manufactured at your facility to be adulterated within the
meaning of Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the
Act).
Animal feeds and feed ingredients containing any mammalian derived protein
(prohibited material), such as bovine meat and bone meal, are considered
potentially injurious to ruminant and public health. Therefore, the use of such
materials in ruminant feed causes the feed to be adulterated under Section
402(a)(4) of the Act.
Our inspection revealed that your firm manufactures feed for sheep, that
may contain residues of prohibited material. Your sheep feed is mixed in the
same equipment that is used for mixing chicken feed containing bovine meat and
bone meal. Your sheep, which are given this feed, are ultimately auctioned for
sale as food for human consumption.
A list of Inspectional Observations (FDA Form 483) was issued to your firm
and discussed with you at the conclusion of the inspection. The following
violations were observed during the inspection:
Failure to use clean-out procedures or other means adequate to prevent
carryover of protein derived from mammalian tissue to animal protein or feeds
that may be used for ruminants, 21 C.F.R. 589.2000(e)(1)(iii)(A) and (B).
Specifically, raw ingredients, such as soybean meal, limestone, dehydrated
alfalfa meal, and meat and bone meal (bovine) pass through shared equipment.
Your firm does not conduct any form of clean-out between delivery of meat and
bone meal and other feed ingredients like alfalfa meal, limestone, and soybean
meal used in both chicken and sheep formulas.
Additionally, there is no clean-out between batches of chicken feed which
contain the meat and bone meal and the sheep feed which is not intended to
contain the meat and bone meal.
Failure to maintain written clean-out procedures to prevent carryover of
protein derived from mammalian tissues to animal protein or feeds that may be
used for ruminants, 21 C.F.R. 589.2000(e)(l)(iv). Specifically, your firm does
not have any written clean-out procedure to prevent cross-contamination between
the sheep feed and the chicken feed nor do they practice/conduct any clean-out
procedures to prevent the cross-contamination between the chicken feed and sheep
feed.
The above is not intended to be an all-inclusive list of deficiencies by
your firm. As a feed manufacturer and ruminant feeder of sheep intended for
slaughter as food, you are responsible for ensuring that your operations are in
full compliance with the law. We have attached a copy of the BSE regulations to
assist you in meeting complete compliance under the law.
We are in receipt of your letter to this office dated September 13, 2002,
in which you state your "intent to not manufacture any sheep feed for the
immediate future." It is unclear to us from your letter whether you intend to
permanently discontinue manufacturing feed for sheep and whether you are now
purchasing ruminant feed from some other source. We cannot stress enough the
seriousness of these deficiencies, and the importance of your firm being in
complete compliance with the BSE regulations in regard to the mixing of ruminant
feed, and feeding and marketing of ruminant animals. Your firm must adhere to
the regulations to assure a safe ruminant feed and meat supply, or establish
complete and separate receiving, mixing, handling, and feeding conveyances and
equipment for ensuring such safety.
In your letter, you also indicated your unfamiliarity with the concept of
"residuals" of prohibited materials being carried over into ruminant feeds, and
you imply that discussions concerning residuals were not held with your firm
during FDA’s previous inspections. For your information, FDA conducted
inspections of your firm on July 27, 1999, and again on December 4, 2001 for
coverage of the BSE regulations. During both inspections, investigators
questioned your plant manager, John Brown, about the activities of your firm
relative to BSE, including specific questions addressing whether your firm was a
feeder of ruminant animals. During both inspections, it was also not conveyed to
our investigators that your firm raises sheep (for slaughter as food) at this
facility or manufactures feed for sheep. Therefore, during each of those
inspections no discussion was held regarding "residuals" of prohibited material
being carried over to ruminant feeds. We have attached copies of the following
FDA guidance documents for your review: FDA Guidance for Industry 68 - Small
Entities Compliance Guide -
Protein Blenders, Feed Manufacturers, and Distributors; Guide 69 - Feeders
of Ruminant Animals With On-Farm Feed Mixing Operations; Guide 70 - Feeders of
Ruminant Animals Without On-Farm Mixing Operations; and Guide 76 - Questions and
Answers BSE Feed Regulation.
You should take prompt action to correct these deviations, and establish
procedures whereby such violations do not recur. Failure to promptly correct
these deviations may result in regulatory action without further notice. Such
action could include, but is not limited to seizure and/or injunction.
You should notify this office in writing within fifteen (15) working days
of receipt of this letter of the specific actions taken to bring your firm in to
compliance with the law. Your response should include an explanation of each
step taken, including any plans to be taken to correct the violations that would
involve the continued use of the common mixing equipment for both sheep and
chicken feeds, and a timeframe for completion of the planned corrections. As
part of your written response, you should provide information regarding the
current feeding practices for sheep being kept at your facility, and information
about the current or planned marketing of such animals for slaughter.
Your written response should be directed to James R. Lahar, Compliance
Officer, at the above address. If you have any questions, you may contact Mr.
Lahar by telephone at (214) 253-5219.
Sincerely,
/s/
Reynaldo R. Rodriguez Jr. for Michael A. Chappell
Dallas District Director
===================================================
Subject: BSE--U.S. 50 STATE CONFERENCE CALL
Jan. 9, 2001 Date: Tue, 9 Jan 2001 16:49:00 –0800
From: "Terry S. Singeltary Sr." Reply-To: Bovine Spongiform Encephalopathy
BSE-L
snip...end
Date: Wed, 29 Jan 2003 12:26:10 -0600
Reply-To: Bovine Spongiform Encephalopathy
Sender: Bovine Spongiform Encephalopathy
From: "Terry S. Singeltary Sr."
Subject: MAD COW/SHEEP FEED BAN WARNING LETTER 'TEXAS' [holy madcow,
must have missed this one 11/7/02]
######## Bovine Spongiform Encephalopathy #########
greetings list members,
i'm still here, but i find it odd that they happen to slide this one by me?
i do not recall this one ever being posted on the TUESDAY warning letters
post??? regardless, i have it now, and so do you. also, this goes to show you of
my concern at the Jan. 9, 2001 BSE Emergency Conference call, when i stated how
shocked i was as to how many folks in the 'industry' knew nothing of the
supposedly 8/4/97 ruminant-to-ruminant voluntary feed ban. either they were
sincere about not knowing about it, or they were just all playing stupid and
simply ignoring it. either way, the consumer will now pay the fiddler for years
to come;
Food and Drug Administration Dallas District 4040 North Central Expressway
Dallas, Texas 75204-3145
November 7, 2002
Re: 2003-DAL-WL- 05 WARNING LETTER CERTIFIED MAIL RETURN RECIEPT REQUESTED
Mr. Ronald A. Christensen President & General Manager Sunnymead Ranch,
Inc. Rt. 1, Box 49 Idalou, TX 79329
Dear Mr. Christensen:
An inspection of your feed mill located at Route 1, Idalou, Texas, was
conducted by Food and Drug Administration (FDA) Investigator Lisa Yoder on
September 9/11, 2002. The inspection found significant deviations from the
requirements set forth in Title 21, Code of Federal Regulations, Part 589.2000 -
Animal Proteins Prohibited in Ruminant Feed (21 C.F.R. 589.2000). This
regulation is intended to prevent the establishment and amplification of Bovine
Spongiform Encephalopathy (BSE). The deviations cause the feed for sheep (a
ruminant animal) manufactured at your facility to be adulterated within the
meaning of Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the
Act).
Animal feeds and feed ingredients containing any mammalian derived protein
(prohibited material), such as bovine meat and bone meal, are considered
potentially injurious to ruminant and public health. Therefore, the use of such
materials in ruminant feed causes the feed to be adulterated under Section
402(a)(4) of the Act.
Our inspection revealed that your firm manufactures feed for sheep, that
may contain residues of prohibited material. Your sheep feed is mixed in the
same equipment that is used for mixing chicken feed containing bovine meat and
bone meal. Your sheep, which are given this feed, are ultimately auctioned for
sale as food for human consumption.
A list of Inspectional Observations (FDA Form 483) was issued to your firm
and discussed with you at the conclusion of the inspection. The following
violations were observed during the inspection:
Failure to use clean-out procedures or other means adequate to prevent
carryover of protein derived from mammalian tissue to animal protein or feeds
that may be used for ruminants, 21 C.F.R. 589.2000(e)(1)(iii)(A) and (B).
Specifically, raw ingredients, such as soybean meal, limestone, dehydrated
alfalfa meal, and meat and bone meal (bovine) pass through shared equipment.
Your firm does not conduct any form of clean-out between delivery of meat and
bone meal and other feed ingredients like alfalfa meal, limestone, and soybean
meal used in both chicken and sheep formulas.
Additionally, there is no clean-out between batches of chicken feed which
contain the meat and bone meal and the sheep feed which is not intended to
contain the meat and bone meal.
Failure to maintain written clean-out procedures to prevent carryover of
protein derived from mammalian tissues to animal protein or feeds that may be
used for ruminants, 21 C.F.R. 589.2000(e)(l)(iv). Specifically, your firm does
not have any written clean-out procedure to prevent cross-contamination between
the sheep feed and the chicken feed nor do they practice/conduct any clean-out
procedures to prevent the cross-contamination between the chicken feed and sheep
feed.
The above is not intended to be an all-inclusive list of deficiencies by
your firm. As a feed manufacturer and ruminant feeder of sheep intended for
slaughter as food, you are responsible for ensuring that your operations are in
full compliance with the law. We have attached a copy of the BSE regulations to
assist you in meeting complete compliance under the law.
We are in receipt of your letter to this office dated September 13, 2002,
in which you state your "intent to not manufacture any sheep feed for the
immediate future." It is unclear to us from your letter whether you intend to
permanently discontinue manufacturing feed for sheep and whether you are now
purchasing ruminant feed from some other source. We cannot stress enough the
seriousness of these deficiencies, and the importance of your firm being in
complete compliance with the BSE regulations in regard to the mixing of ruminant
feed, and feeding and marketing of ruminant animals. Your firm must adhere to
the regulations to assure a safe ruminant feed and meat supply, or establish
complete and separate receiving, mixing, handling, and feeding conveyances and
equipment for ensuring such safety.
In your letter, you also indicated your unfamiliarity with the concept of
"residuals" of prohibited materials being carried over into ruminant feeds, and
you imply that discussions concerning residuals were not held with your firm
during FDA’s previous inspections. For your information, FDA conducted
inspections of your firm on July 27, 1999, and again on December 4, 2001 for
coverage of the BSE regulations. During both inspections, investigators
questioned your plant manager, John Brown, about the activities of your firm
relative to BSE, including specific questions addressing whether your firm was a
feeder of ruminant animals. During both inspections, it was also not conveyed to
our investigators that your firm raises sheep (for slaughter as food) at this
facility or manufactures feed for sheep. Therefore, during each of those
inspections no discussion was held regarding "residuals" of prohibited material
being carried over to ruminant feeds. We have attached copies of the following
FDA guidance documents for your review: FDA Guidance for Industry 68 - Small
Entities Compliance Guide -
Protein Blenders, Feed Manufacturers, and Distributors; Guide 69 - Feeders
of Ruminant Animals With On-Farm Feed Mixing Operations; Guide 70 - Feeders of
Ruminant Animals Without On-Farm Mixing Operations; and Guide 76 - Questions and
Answers BSE Feed Regulation.
You should take prompt action to correct these deviations, and establish
procedures whereby such violations do not recur. Failure to promptly correct
these deviations may result in regulatory action without further notice. Such
action could include, but is not limited to seizure and/or injunction.
You should notify this office in writing within fifteen (15) working days
of receipt of this letter of the specific actions taken to bring your firm in to
compliance with the law. Your response should include an explanation of each
step taken, including any plans to be taken to correct the violations that would
involve the continued use of the common mixing equipment for both sheep and
chicken feeds, and a timeframe for completion of the planned corrections. As
part of your written response, you should provide information regarding the
current feeding practices for sheep being kept at your facility, and information
about the current or planned marketing of such animals for slaughter.
Your written response should be directed to James R. Lahar, Compliance
Officer, at the above address. If you have any questions, you may contact Mr.
Lahar by telephone at (214) 253-5219.
Sincerely,
/s/
Reynaldo R. Rodriguez Jr. for Michael A. Chappell
Dallas District Director
===================================================
Subject: Re: USA ruminant-to-ruminant feed ban warning letters (Advisory
Panels Stacked, Scientists Warn)
Date: Fri, 24 Jan 2003 08:37:49 –0600
From: "Terry S. Singeltary Sr."
To: Bovine Spongiform Encephalopathy References:
<3e075c47 .3080506=".3080506" wt.net="wt.net"> <3e21ba6c .3040900=".3040900" wt.net="wt.net">
<3e23107a .433c64bf=".433c64bf" airtime.co.uk="airtime.co.uk"> 3E232ABD.8000005@wt.net
Advisory Panels Stacked, Scientists Warn
By J.R. Pegg
WASHINGTON, DC, January 23, 2003 (ENS) - American scientists are growing
increasingly worried that the Bush administration is manipulating scientific
advisory committees in order to further its political agenda.
The federal government relies on hundreds of these committees to provide
agencies with unbiased advice based on the best science available as well as to
peer review grant proposals for scientific research.
The Bush administration, many scientists fear, has distorted this process
by putting committee members through political litmus tests, eliminating
committees whose findings looked likely to disagree with its policies, and
stacking committees with individuals who have a vested interest in steering
conclusions to benefit effected industries.
scientist Scientist John Turner holds a beaker containing a solar cell
electrolyzer submerged in an alkaline aqueous solution. (Photo by Richard
Peterson courtesy NREL) "We've seen a consistent pattern of putting people in
who will ensure that the administration hears what it wants to hear," said Dr.
David Michaels, a research professor in the Department of Environmental and
Occupational Health at George Washington University's School of Public Health.
Addressing reporters at a press briefing today in Washington, Dr. Michaels said,
"That doesn't help science, and it doesn't help the country."
The Bush administration says it is doing what every other administration
has done in the past, but many scientists take issue with this defense.
"The Clinton administration did not do this," said Dr. Lynn Goldman, a
pediatrician and professor at the Bloomberg School of Public Health at Johns
Hopkins University. "They did not exclude people based on some sort of litmus
test." Goldman Pediatrician Dr. Lynn Goldman was assistant administrator of the
Office of Prevention, Pesticides and Toxic Substances of the U.S. EPA under the
Clinton administration. (Photo courtesy Johns Hopkins Magazine)
"These are not just the concerns of a few scientists or members of the
public health community but of a broad array of people across the country,"
added Kelly O'Brien, associate executive director of public affairs for the
American Public Health Association (APHA).
The role of these committees is not to tell the administration what they
want to hear, Michaels argues, but to tell them what science has concluded about
the issue under discussion.
"You hire political appointees to move your political agenda forward," he
observes. "But the role of scientific advisory committees is quite different. It
is to give advice to the agencies and to the public on what is the best
science."
"This is a threat to the fundamental principles that we want to make
decisions based on the best available science," Goldberg added.
Americans may be unfamiliar with the role of scientific advisory
committees, but the impact of the advice they give is extensive. Rules and
regulations that govern clean air, clean water, food safety and pesticide use,
among others, have been devised with scientific advice from such committees.
The growing concern from American scientists comes from a slew of examples.
Members of the Center for Disease Control's (CDC) Advisory Committee on
Childhood Lead Poisoning Prevention were replaced last year with individuals
with close ties to the lead industry, including Dr. William Banner, who has
provided written testimony on behalf of lead industry defendants in a lawsuit in
Rhode Island.
Banner is on record as believing that lead is only harmful in levels that
are seven to 10 times higher than the current CDC blood lead levels. The CDC
estimates some 890,000 U.S. children ages one to five have elevated levels of
lead in their blood.
Fifteen of the 18 members of the Advisory Committee to the Director of the
National Health Center for Environmental Health were replaced last year. This
committee assesses the health impact of exposure to environmental chemicals.
Among the new members is the former president of the Chemical Industry Institute
for Toxicology.
Thompson Health and Human Services Secretary Tommy Thompson (Photo courtesy
U.S. Government) Tommy Thompson, Secretary of the Department of Health and Human
Services (HHS), dissolved a committee charged with analyzing the federal system
for protecting human research subjects. A committee tasked with giving the U.S.
Food and Drug Administration advice on oversight of the genetics testing
industry was similarly disbanded.
A respected scientist nominated to serve on an HHS peer review study
section, which is charged with reviewing research grant proposals submitted to
the National Institute for Occupational Safety and Health, was rejected for her
support of an ergonomics rule overturned by the Bush administration last year.
A consultant to the Army Science Board was disapproved for full membership
on the committee because, he was told, he contributed to Senator John McCain's
campaign, an allegation that was false.
A new member of the Food and Drug Administration's Reproductive Health
Drugs Advisory Committee, Dr. David Hager, helped the Christian Medical
Association lobby for a safety review of a drug the committee approved two years
ago. The announcement that Hager, who has very few research credits, had been
put on the committee was released on Christmas Eve.
The trouble with this politicization of the process by which scientists
advise the government, Michaels explained, is that they will directly impact the
government's willingness to act.
"I don't think there is really any danger of a committee coming out and
making a statement so far out of the mainstream that it takes us in a different
direction," he explained. "What these committees will do, and I think this is
what the administration wants, is to essentially throw their hands up and say
there is too much uncertainty. That sort of paralysis is dangerous."
Apple Dr. Martin Apple (Photo courtesy University of Kansas Merrill
Advanced Studies Center) The trust the public has in science, and in the
scientific advice offered by the government for public health issues, could be
gravely affected by these developments, said Dr. Martin Apple, president of the
Council of Scientific Society Presidents.
"Public trust is like Humpty Dumpty," Apple said. "It is difficult to
establish, easy to lose and nearly impossible to restore."
It is not that anyone expects scientific advisory committee members to be
completely unbiased, Goldman said. Rather, it is critical that these committees
are focused only on the science, leaving political, economic and religious bias
out of the equation.
"If you attempt to predetermine the outcome of the scientific discussion by
selecting certain people for science committees or by constructing a consensus
before you bring the group together, then you are distorting the process,"
Goldman added. "For the past several months, again and again with this current
administration, we've seen evidence of this occurring."
Goldman, who served as the assistant administrator for the Office of
Prevention, Pesticide and Toxic Substances within the Environmental Protection
Agency (EPA) from 1993 to 1998, has firsthand experience with the Bush
administration's policy on scientific advisory committees. Goldman and two other
experts on the effects of pesticides on children were invited to speak at an EPA
funded conference that was scheduled for September 2002.
In July 2002, representatives from the pesticides industry wrote to the EPA
to protest the conference and specifically the participation of Goldman and the
other two scientists at the event. The EPA then rescheduled the conference for
June 2003 and has not re invited any of the three.
The overarching concern, Goldman said, is the apparent influence of the
pesticide industry on the EPA.
Waxman Congressman Henry Waxman has represented the Los Angeles area since
1974. (Photo courtesy Office of the Representative) California Representative
Henry Waxman, a Democrat, agreed and sent EPA Administrator Christie Todd
Whitman a letter on December 20, 2002 asking for an explanation by January 6,
2003.
Waxman's spokesperson Karen Lightfoot told ENS that the Congressman has not
received any response from the EPA.
In late October 2002, Waxman and 11 other members of Congress sent a letter
to HHS Secretary Thompson, detailing concern with "a pattern of events …
suggesting that scientific decision making is being subverted by ideology and
that scientific information that does not fit the administration's political
agenda is being suppressed."
HHS did reply to Waxman and his colleagues, but their explanations did not
satisfy the letter writers. A subsequent letter asking for more detailed
information was sent on December 18, 2002.
Lightfoot said there has been no response to the December 18 letter, but
added that Congressman Waxman will closely monitor "this trend of putting
ideology before science."
Groups like the American Public Health Association, which has some 50,000
members, are calling on Congress to further explore just what the Bush
administration is doing with scientific advisory committees. APHA drafted a
series of recommendations, including the reevaluation of newly reconstituted
advisory panels and the creation of criteria to guide the selection of members
on public health advisory committees and peer review research committees at all
levels of government - federal, state and local.
poster Poster for the Scientific Computing Division Advisory Panel convened
by the National Center for Atmospheric Research (Photo courtesy ) There is
concern that if the process continues forward without serious review that many
qualified scientists will decline to involve themselves with future committees.
"Scientists and the federal government in the United States have
established an effective system of providing expert advice," Apple said. "But
the best scientists are only willing to serve on such advisory groups when they
believe that they are unbiased and will produce scientifically sound results.
Once this currency is debased, the best scientists will decline to take the time
out from their lives to participate, and the government will lose an
irreplaceable resource."
"This will cause severe and last damage to the national interest and should
be actively prevented," Apple urged.
There is "no glory" for scientists to take part in the vast majority of
scientific advisory committees, Michaels said. They are only compensated for
travel and accommodations, and the work is often long and tedious.
"It is quite possible that these are isolated, anecdotal incidents,"
Goldman suggested. "But then why hasn't there been an attempt to rectify them?"
Copyright Environment News Service (ENS) 2003. All Rights Reserved.
Terry S. Singeltary Sr. wrote:
> ######## Bovine Spongiform Encephalopathy
> #########
>
> hello Dr. Dealler,
>
> please do not hold your breath for any USA
> ruminant-to-ruminant feed ban warning letters
> since May of 2002 to be released anytime soon,
> this could be fatal for you;-)
> i have not gotten them yet, if any exist.
> but i am trying.
> hopefully GW et al will not think i am one of
> the terrorist, and will allow for this information
> to be released (with no charge attached$$$)...
>
> kindest regards,
> terry
>
> Steve Dealler wrote:
>
>> ######## Bovine Spongiform Encephalopathy
>> #########
>>
>> This was absolutely excellent for Terry to have got this from the
US
>> Government...you should have tried getting this sort of thing from
>> MAFF in the UK
>> at the beginning of the nineties!
>> Steve Dealler
>>
>> "Terry S. Singeltary Sr." wrote:
>>
>>
>>> ######## Bovine Spongiform Encephalopathy
>>> #########
>>>
>>> Greetings List Members,
>>>
>>> as you know, i finally had to request to the FOIA
>>> for the USA madcow feed ban warning letters. so i
thought
>>> some of you may be interested in an update on this
matter.
>>>
>>> so here it is;
>>>
>>> Subject: Request to FDA via FOIA of ALL USA
Ruminant-to-Ruminant Feed
>>> Ban Violations Jan. 2001 to Jan. 2003
>>> Date: Mon, 6 Jan 2003 08:32:43 -0600
>>> From: "Terry S. Singeltary Sr."
>>> Reply-To: Bovine Spongiform Encephalopathy
>>> To: BSE-L
>>>
>>> Food and Drug Administration
>>> Office of Information Resources Management
>>> Division of Freedom of Information (HFI-35)
>>> 5600 Fishers Lane
>>> Rockville, MD 20857
>>>
>>> Or requests may be sent via fax to: (301) 443-1726. If there
are
>>> problems sending a fax, call (301) 443-2414.
>>>
>>> 1/6/03
>>>
>>> Request to FDA via FOIA of ALL USA Ruminant-to-Ruminant Feed
Ban
>>> Violations Jan. 2001 to Jan. 2003
>>>
>>> Greetings FDA and To Whom it may concern,
>>>
>>> i wish to request all ruminant-to-ruminant feed ban violations
from Jan.
>>> 2001 to Jan. 2003. it seems none has been posted since May
2001 on the
>>> FDA site. I also kindly request that all fees be wavered due
to the fact
>>> this is public information, public health is at risk, and
this
>>> will be distributed 'freely' to the public...
>>>
>>> thank you,
>>> kind regards,
>>>
>>> I am sincerely,
>>>
>>> Terry S. Singeltary Sr.
>>> P.O. Box Bacliff, Texas USA 77518
>>> CJD Watch
>>>
==========================================================
>>>
>>> now since then, just this past Friday 1/10/03, i get this
from
>>> FDA;
>>>
>>> REPLY FROM DPH/FDA to TSS;
>>>
>>> PLEASE note, my request was for all R-T-R feed ban
>>> violations from Jan. 2001 to Jan. 2003. BUT in the
>>> reply, they posted Jan. 2002 to Jan. 2003. i called
>>> and this is to be corrected. hopefully this FOIA
>>> request will ignite some enthusiasm from the FDA
>>> into posting to the public any R-T-R MAD COW
>>> FEED BAN violations, since GW et al new policy
>>> on secrecy took effect on this matter in May of 2002
>>> (correcting my below 'since May 2001).
>>>
>>> TSS
>>>
>>> Department of Health & Human Services
>>>
>>> Food and Drug Administration
>>> Rockville MD 20857
>>>
>>> 1/7/03
>>>
>>> In reply refer to;
>>>
>>> xxxxxxx
>>>
>>> Dear Requester,
>>>
>>> The Food and Drug Administration (FDA) has received your
>>> Freedom of Information Act (FOIA) request for records
>>> regarding;
>>>
>>> RUMINANT-TO-RUMINANT FEED - BAN VIOLATIONS 1/02 - 1/03
>>>
>>> We will respond as soon as possible and may charge you a
fee
>>> for processing your request. If you have any questions
>>> about your request, please call Edna G. Wilkerson,
>>> Information Technician, at 301-827-6564 or write to us
>>> at;
>>>
>>> Food and Drug Administration
>>> Division of Freedom of Information
>>> 5600 Fishers Lance, HFI - 35
>>> Rockville, MD 20857
>>>
>>> If you call or write, use the reference number above
>>> which will help us to answer your questions more
quickly...
>>>
===========================================================
>>> now, Sunday, i read this in the Houston Chronicle
1/12/03;
>>>
>>> SENATOR AIMS TO UPGRADE FREEDOM OF INFORMATION
>>>
>>> TEXAS Sen. John Coprnyn says he wants to improve public access
to
>>> government records in Washington, a position that appears to
put
>>> him at odds with the Bush administration.
>>>
>>> Cornyn, a moderate Republican who sits on the Senate
Judiciary
>>> Committee, said he'll work on legislation in the coming weeks
to
>>> improve the Freedom of Information Act.
>>>
>>> "FOIA needs to be strenghened," he said, "We need to quicken
the
>>> turnaround time and create a mechanism that allows an
indepentent,
>>> third party to decide whether a record should be kept
secret."
>>>
>>> Echoing sentiments he expressed while serving as Texas
attorney
>>> general, Cornyn added: "I believe in a system of
governement
>>> that allows consent of the people. And people can't consent if
they
>>> don't what their elected officials are doing."
>>>
>>> Since taking office two years ago, the Bush Administration
has
>>> taken steps to restrict access to governement information, an
effort
>>> that was accelerated in the name of national security
following
>>> the Sept. 11 terrorist attacks......
>>>
>>> Greetings again BSE-L list members,
>>>
>>> how would _USA_ ruminant-to-ruminant feed ban warning
>>> letters have anything to do with terrorism and National
>>> Security?
>>>
snip>>>
>>> Date: Wed, 2 Oct 2002 09:04:42 -0700
>>> Reply-To: Bovine Spongiform Encephalopathy
>>> Sender: Bovine Spongiform Encephalopathy
>>> From: "Terry S. Singeltary Sr."
>>> Subject: MAD COW FEED BAN WARNING LETTERS USA 'update' (where
did
>>> all Terry's MAD COW warning letters go?)
>>>
>>> snip...END...2012...TSS
snip...end...2012...TSS
----- Original Message -----
From: "Terry S. Singeltary Sr." flounder9@VERIZON.NET
To: BSE-L@aegee.org
Sent: Tuesday, November 07, 2006 11:21 AM
Subject: MAD COW FDA FEED WARNING LETTER NO. 2007-NOL-01 October 26, 2006
H.J. Baker & Bro., Inc.
##################### Bovine Spongiform Encephalopathy
#####################
Subject: MAD COW FDA FEED WARNING LETTER NO. 2007-NOL-01 October 26, 2006
H.J. Baker & Bro., Inc.
Date: November 7, 2006 at 9:08 am PST Food and Drug Administration
New Orleans District
404 BNA Drive, Building 200, Suite 500
Nashville, TN 37217
Telephone: 615-366-7801
Facsimile: 615-366-7802
October 26, 2006
WARNING LETTER NO. 2007-NOL-01
FEDERAL EXPRESS
OVERNIGHT DELIVERY
Mr. Christopher V. B. Smith
Corporate President, CEO
H. J. Baker & Bro., Inc.
228 Saugatuck Avenue
Westport, Connecticut 06880
Dear Mr. Smith:
On June 6, 8, 12-15, and 23, 2006, a U.S . Food and Drug Administration
(FDA) investigator inspected your animal feed protein supplement manufacturing
facility, located at 603 Railroad Avenue,Albertville, Alabama. The inspection
revealed significant deviations from the requirements set forth in Title 21,
Code ofFederal 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, resulting in products
being manufactured and distributed by your facility because they are adulterated
within the meaning of Section 402(a)(4) [21 USC 342(a)(4)] of the Federal Food,
Drug, and Cosmetic Act (the Act) and misbranded within the meaning of Section
403(a)(1) [21 USC 343(a)(1)] of the Act.
Our investigation determined adulteration resulted from the failure of your
firm to establish and implement measures sufficient to prevent commingling or
cross-contamination . The adulterated feed was subsequently misbranded because
it was not properly labeled. Specifically, we found :
" Your firm failed to establish and use cleanout procedures or other means
to prevent carry-over of products which contain or may contain protein derived
from mammalian tissues into animal protein or feeds which may be used for
ruminants, as required by 21 CFR 589.2000(e)(1)(iii)(B) .
Specifically, you failed to establish and use such measures for a screw
auger installed in February 2005 . This auger is used to convey both prohibited
and non-prohibited material to bulk storage bins.
In addition, you failed to follow the cleanout procedure your firm had
developed for the receiving systems. Your feed is, therefore, adulterated under
Section 402(a)(4) [21 USC 342(a)(4)] of the Act.
" You failed to label all products which contained or may have contained
prohibited materials with the BSE cautionary statement, "Do not feed to cattle
or other ruminants," as required by 21 CFR 589.2000(e)(1)(i) . Such products are
misbranded under Section 403(3) [21 USC 343(a)(1)] of the Act. These misbranded
products include the three Pro-Pak products mentioned below, as well as
Page 2 - H. J . Baker & Bro., Inc., Albertville, Alabama Warning
Letter No. 2007-NOL-O 1
those bulk loads of individual feed ingredients processed through this
common screw auger and distributed between the time it was installed in February
2005, and June 9, 2006 .
This letter is not intended to serve 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.
We acknowledge your June 16, 2006, voluntary recall of three products you
manufactured from February 2005 to June 2006. The three products recalled were:
Pro-Lak Protein Concentrate for Lactating Dairy Animals; Pro-Amino II for
PreFresh and Lactating Cows; and, Pro-Pak Marine & Animal Protein
Concentrate for Use in Animal Feed.
Recall effectiveness checks and other measures will determine the merit of
this recall . We recognize you now label all products with the required BSE
cautionary statement and we also acknowledge your intent, given verbally to New
Orleans District management of the FDA, to discontinue the production of
supplements which do not contain prohibited materials. In your written response
to this letter, please confirm in writing you have taken these steps.
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, including the steps we acknowledge above and
any additional steps you have taken. 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 Kari L. Batey, Compliance Officer, at the
address above. If you have
questions regarding any issue in this letter, please contact Ms. Batey at
(615) 366-7808.
Sincerely,
,
Carol S . Sanchez
Acting District Director
New Orleans District
Enclosure: Form FDA 483
cc: Craig R. Waterhouse
Plant Manager
H.J. Baker & Bros., Inc.
603 Railroad Avenue
Albertville, Alabama 35951-3419
TSS
MORE 2006 FEED BAN VIOLATIONS BELOW, ''IN COMMERCE'' ;
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
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
###
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
###
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
###
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
###
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
###
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
P.9.21
Molecular characterization of BSE in Canada
Jianmin Yang1, Sandor Dudas2, Catherine Graham2, Markus Czub3, Tim
McAllister1, Stefanie Czub1 1Agriculture and Agri-Food Canada Research Centre,
Canada; 2National and OIE BSE Reference Laboratory, Canada; 3University of
Calgary, Canada
Background: Three BSE types (classical and two atypical) have been
identified on the basis of molecular characteristics of the misfolded protein
associated with the disease. To date, each of these three types have been
detected in Canadian cattle.
Objectives: This study was conducted to further characterize the 16
Canadian BSE cases based on the biochemical properties of there associated
PrPres. Methods: Immuno-reactivity, molecular weight, glycoform profiles and
relative proteinase K sensitivity of the PrPres from each of the 16 confirmed
Canadian BSE cases was determined using modified Western blot analysis.
Results: Fourteen of the 16 Canadian BSE cases were C type, 1 was H type
and 1 was L type. The Canadian H and L-type BSE cases exhibited size shifts and
changes in glycosylation similar to other atypical BSE cases. PK digestion under
mild and stringent conditions revealed a reduced protease resistance of the
atypical cases compared to the C-type cases. N terminal- specific antibodies
bound to PrPres from H type but not from C or L type. The C-terminal-specific
antibodies resulted in a shift in the glycoform profile and detected a fourth
band in the Canadian H-type BSE.
Discussion: The C, L and H type BSE cases in Canada exhibit molecular
characteristics similar to those described for classical and atypical BSE cases
from Europe and Japan. This supports the theory that the importation of BSE
contaminated feedstuff is the source of C-type BSE in Canada. *** It also
suggests a similar cause or source for atypical BSE in these countries.
PRION 2009 CONGRESS BOOK OF ABSTRACTS
O.4.3
Spread of BSE prions in cynomolgus monkeys (Macaca fascicularis) after oral
transmission
Edgar Holznagel1, Walter Schulz-Schaeffer2, Barbara Yutzy1, Gerhard
Hunsmann3, Johannes Loewer1 1Paul-Ehrlich-Institut, Federal Institute for Sera
and Vaccines, Germany; 2Department of Neuropathology, Georg-August University,
Göttingen, Germany, 3Department of Virology and Immunology, German Primate
Centre, Göttingen, Germany
Background: BSE-infected cynomolgus monkeys represent a relevant animal
model to study the pathogenesis of variant Creutzfeldt-Jacob disease
(vCJD).
Objectives: To study the spread of BSE prions during the asymptomatic phase
of infection in a simian animal model.
Methods: Orally BSE-dosed macaques (n=10) were sacrificed at defined time
points during the incubation period and 7 orally BSE-dosed macaques were
sacrificed after the onset of clinical signs. Neuronal and non-neuronal tissues
were tested for the presence of proteinase-K-resistant prion protein (PrPres) by
western immunoblot and by paraffin-embedded tissue (PET) blot technique.
Results: In clinically diseased macaques (5 years p.i. + 6 mo.), PrPres
deposits were widely spread in neuronal tissues (including the peripheral
sympathetic and parasympathetic nervous system) and in lymphoid tissues
including tonsils. In asymptomatic disease carriers, PrPres deposits could be
detected in intestinal lymph nodes as early as 1 year p.i., but CNS tissues were
negative until 3 – 4 years p.i. Lumbal/sacral segments of the spinal cord and
medulla oblongata were PrPres positive as early as 4.1 years p.i., whereas
sympathetic trunk and all thoracic/cervical segments of the spinal cord were
still negative for PrPres. However, tonsil samples were negative in all
asymptomatic cases.
Discussion: There is evidence for an early spread of BSE to the CNS via
autonomic fibres of the splanchnic and vagus nerves indicating that
trans-synaptical spread may be a time-limiting factor for neuroinvasion. Tonsils
were predominantly negative during the main part of the incubation period
indicating that epidemiological vCJD screening results based on the detection of
PrPres in tonsil biopsies may mostly tend to underestimate the prevalence of
vCJD among humans.
P04.27
Experimental BSE Infection of Non-human Primates: Efficacy of the Oral
Route
Holznagel, E1; Yutzy, B1; Deslys, J-P2; Lasmézas, C2; Pocchiari, M3;
Ingrosso, L3; Bierke, P4; Schulz-Schaeffer, W5; Motzkus, D6; Hunsmann, G6;
Löwer, J1 1Paul-Ehrlich-Institut, Germany; 2Commissariat à l´Energie Atomique,
France; 3Instituto Superiore di Sanità, Italy; 4Swedish Institute for Infectious
Disease control, Sweden; 5Georg August University, Germany; 6German Primate
Center, Germany
Background:
In 2001, a study was initiated in primates to assess the risk for humans to
contract BSE through contaminated food. For this purpose, BSE brain was titrated
in cynomolgus monkeys.
Aims:
The primary objective is the determination of the minimal infectious dose
(MID50) for oral exposure to BSE in a simian model, and, by in doing this, to
assess the risk for humans. Secondly, we aimed at examining the course of the
disease to identify possible biomarkers.
Methods:
Groups with six monkeys each were orally dosed with lowering amounts of BSE
brain: 16g, 5g, 0.5g, 0.05g, and 0.005g. In a second titration study, animals
were intracerebrally (i.c.) dosed (50, 5, 0.5, 0.05, and 0.005 mg).
Results:
In an ongoing study, a considerable number of high-dosed macaques already
developed simian vCJD upon oral or intracerebral exposure or are at the onset of
the clinical phase. However, there are differences in the clinical course
between orally and intracerebrally infected animals that may influence the
detection of biomarkers.
Conclusions:
Simian vCJD can be easily triggered in cynomolgus monkeys on the oral route
using less than 5 g BSE brain homogenate. The difference in the incubation
period between 5 g oral and 5 mg i.c. is only 1 year (5 years versus 4 years).
However, there are rapid progressors among orally dosed monkeys that develop
simian v CJD as fast as intracerebrally inoculated animals.
The work referenced was performed in partial fulfillment of the study “BSE
in primates“ supported by the EU (QLK1-2002-01096).
Simian vCJD can be easily triggered in cynomolgus monkeys on the oral route
using less than 5 g BSE brain homogenate.
look at the table and you'll see that as little as 1 mg (or 0.001 gm)
caused 7% (1 of 14) of the cows to come down with BSE;
Risk of oral infection with bovine spongiform encephalopathy agent in
primates
Corinne Ida Lasmézas, Emmanuel Comoy, Stephen Hawkins, Christian Herzog,
Franck Mouthon, Timm Konold, Frédéric Auvré, Evelyne Correia, Nathalie
Lescoutra-Etchegaray, Nicole Salès, Gerald Wells, Paul Brown, Jean-Philippe
Deslys Summary The uncertain extent of human exposure to bovine spongiform
encephalopathy (BSE)--which can lead to variant Creutzfeldt-Jakob disease
(vCJD)--is compounded by incomplete knowledge about the efficiency of oral
infection and the magnitude of any bovine-to-human biological barrier to
transmission. We therefore investigated oral transmission of BSE to non-human
primates. We gave two macaques a 5 g oral dose of brain homogenate from a
BSE-infected cow. One macaque developed vCJD-like neurological disease 60 months
after exposure, whereas the other remained free of disease at 76 months. On the
basis of these findings and data from other studies, we made a preliminary
estimate of the food exposure risk for man, which provides additional assurance
that existing public health measures can prevent transmission of BSE to
man.
snip...
BSE bovine brain inoculum
100 g 10 g 5 g 1 g 100 mg 10 mg 1 mg 0·1 mg 0·01 mg
Primate (oral route)* 1/2 (50%)
Cattle (oral route)* 10/10 (100%) 7/9 (78%) 7/10 (70%) 3/15 (20%) 1/15 (7%)
1/15 (7%)
RIII mice (ic ip route)* 17/18 (94%) 15/17 (88%) 1/14 (7%)
PrPres biochemical detection
The comparison is made on the basis of calibration of the bovine inoculum
used in our study with primates against a bovine brain inoculum with a similar
PrPres concentration that was
inoculated into mice and cattle.8 *Data are number of animals
positive/number of animals surviving at the time of clinical onset of disease in
the first positive animal (%). The accuracy of
bioassays is generally judged to be about plus or minus 1 log. ic
ip=intracerebral and intraperitoneal.
Table 1: Comparison of transmission rates in primates and cattle infected
orally with similar BSE brain inocula
Published online January 27, 2005
Calves were challenged by mouth with homogenised brain from confirmed cases
of BSE. Some received 300g (3 doses of 100g), some 100g, 10g or 1g. They were
then left to develop BSE, but were not subjected to the normal stresses that
they might have encountered in a dairy herd. Animals in all four groups
developed BSE. There has been a considerable spread of incubation period in some
of the groups, but it appears as if those in the 1 and 10g challenge groups most
closely fit the picture of incubation periods seen in the epidemic. Experiments
in progress indicate that oral infection can occur in some animals with doses as
low as 0.01g and 0.001g. .........
It is clear that the designing scientists must also have shared Mr
Bradley's surprise at the results because all the dose levels right down to 1
gram triggered infection.
6. It also appears to me that Mr Bradley's answer (that it would take less
than say 100 grams) was probably given with the benefit of hindsight;
particularly if one considers that later in the same answer Mr Bradley expresses
his surprise that it could take as little of 1 gram of brain to cause BSE by the
oral route within the same species. This information did not become available
until the "attack rate" experiment had been completed in 1995/96. This was a
titration experiment designed to ascertain the infective dose. A range of
dosages was used to ensure that the actual result was within both a lower and an
upper limit within the study and the designing scientists would not have
expected all the dose levels to trigger infection. The dose ranges chosen by the
most informed scientists at that time ranged from 1 gram to three times one
hundred grams. It is clear that the designing scientists must have also shared
Mr Bradley's surprise at the results because all the dose levels right down to 1
gram triggered infection.
2012
***Also, a link is suspected between atypical BSE and some apparently
sporadic cases of Creutzfeldt-Jakob disease in humans. These atypical BSE cases
constitute an unforeseen first threat that could sharply modify the European
approach to prion diseases.
Second threat
snip...
MAD COW USDA ATYPICAL L-TYPE BASE BSE, the rest of the story...
***Oral Transmission of L-type Bovine Spongiform Encephalopathy in Primate
Model
***Infectivity in skeletal muscle of BASE-infected cattle
***feedstuffs- It also suggests a similar cause or source for atypical BSE
in these countries.
***Also, a link is suspected between atypical BSE and some apparently
sporadic cases of Creutzfeldt-Jakob disease in humans.
The present study demonstrated successful intraspecies transmission of
H-type BSE to cattle and the distribution and immunolabeling patterns of PrPSc
in the brain of the H-type BSE-challenged cattle. TSE agent virulence can be
minimally defined by oral transmission of different TSE agents (C-type, L-type,
and H-type BSE agents) [59]. Oral transmission studies with H-type BSEinfected
cattle have been initiated and are underway to provide information regarding the
extent of similarity in the immunohistochemical and molecular features before
and after transmission.
In addition, the present data will support risk assessments in some
peripheral tissues derived from cattle affected with H-type BSE.
2012 CALIFORNIA ATYPICAL L-TYPE BASE BSE MAD COW, SPONTANEOUS AND FEED $$$
Saturday, May 26, 2012
Are USDA assurances on mad cow case 'gross oversimplification'?
SNIP...
What irks many scientists is the USDA’s April 25 statement that the rare
disease is “not generally associated with an animal consuming infected feed.”
The USDA’s conclusion is a “gross oversimplification,” said Dr. Paul Brown,
one of the world’s experts on this type of disease who retired recently from the
National Institutes of Health. "(The agency) has no foundation on which to base
that statement.”
“We can’t say it’s not feed related,” agreed Dr. Linda Detwiler, an
official with the USDA during the Clinton Administration now at Mississippi
State.
In the May 1 email to me, USDA’s Cole backed off a bit. “No one knows the
origins of atypical cases of BSE,” she said
The argument about feed is critical because if feed is the cause, not a
spontaneous mutation, the California cow could be part of a larger outbreak.
SNIP...
in the url that follows, I have posted
SRM breaches first, as late as 2011.
then
MAD COW FEED BAN BREACHES AND TONNAGES OF MAD COW FEED IN COMMERCE up until
2007, when they ceased posting them.
then,
MAD COW SURVEILLANCE BREACHES.
Friday, May 18, 2012
Update from APHIS Regarding a Detection of Bovine Spongiform Encephalopathy
(BSE) in the United States Friday May 18, 2012
Wednesday, May 30, 2012
PO-028: Oral transmission of L-type bovine spongiform encephalopathy
(L-BSE) in primate model Microcebus murinus
Monday, July 23, 2012
The National Prion Disease Pathology Surveillance Center July 2012
Wednesday, June 27, 2012
First US BSE Case Since 2006 Underscores Need for Vigilance
Neurology Today 21 June 2012
Thursday, June 21, 2012
MEATINGPLACE.COM WAVES MAGIC WAND AND EXPECTS THE USDA MAD COW FOLLIES BSE
TO BE GONE
Thursday, June 14, 2012
R-CALF USA Calls USDA Dishonest and Corrupt; Submits Fourth Request for
Extension
R-CALF United Stockgrowers of America
Friday, May 25, 2012
R-CALF USDA’s New BSE Rule Eliminates Important Protections Needed to
Prevent BSE Spread
Monday, June 18, 2012
R-CALF Submits Incomplete Comments Under Protest in Bizarre Rulemaking
“Bovine Spongiform Encephalopathy; Importation of Bovines and Bovine Products”
Saturday, March 5, 2011
MAD COW ATYPICAL CJD PRION TSE CASES WITH CLASSIFICATIONS PENDING ON THE
RISE IN NORTH AMERICA
Wednesday, November 09, 2011
Case report Sporadic fatal insomnia in a young woman: A diagnostic
challenge: Case Report TEXAS
HOW TO TURN A POTENTIAL MAD COW VICTIM IN THE USA, INTO A HAPPENSTANCE OF
BAD LUCK, A SPONTANEOUS MUTATION FROM NOTHING. OR WAS IT $$$
Sunday, February 12, 2012
National Prion Disease Pathology Surveillance Center Cases Examined1
(August 19, 2011) including Texas
snip...
CJD TEXAS 38 YEAR OLD FEMALE WORKED SLAUGHTERING CATTLE EXPOSED TO BRAIN
AND SPINAL CORD MATTER
Irma Linda Andablo CJD Victim, she died at 38 years old on February 6, 2010
in Mesquite Texas
Irma Linda Andablo CJD Victim, she died at 38 years old on February 6, 2010
in Mesquite Texas. She left 6 Kids and a Husband. The Purpose of this web is to
give information in Spanish to the Hispanic community, and to all the community
who want's information about this terrible disease.-
Physician Discharge Summary, Parkland Hospital, Dallas Texas
Admit Date: 12/29/2009 Discharge Date: 1/20/2010 Attending Provider:
Greenberg, Benjamin Morris; General Neurology Team: General Neurology Team
snip...
The husband says that they have lived in Nebraska for the past 21 years.
They had seen a doctor there during the summer time who prescribed her Seroquel
and Lexapro, Thinking these were sx of a mood disorder. However, the medications
did not help and she continued to deteriorate clinically. Up until about 6 years
ago, the pt worked at Tyson foods where she worked on the assembly line,
slaughtering cattle and preparing them for packaging. She was exposed to brain
and spinal cord matter when she would euthanize the cattle. The husband says
that he does not know any fellow workers with a similar illness. He also says
that she did not have any preceeding illness or travel.
snip...
>>> Up until about 6 years ago, the pt worked at Tyson foods where
she worked on the assembly line, slaughtering cattle and preparing them for
packaging. She was exposed to brain and spinal cord matter when she would
euthanize the cattle. <<<
SEE MORE HERE ;
CJD TEXAS 38 YEAR OLD FEMALE WORKED SLAUGHTERING CATTLE EXPOSED TO BRAIN
AND SPINAL CORD MATTER
Sunday, February 12, 2012
National Prion Disease Pathology Surveillance Center Cases Examined1
(August 19, 2011) including Texas
Tuesday, November 08, 2011
Can Mortality Data Provide Reliable Indicators for Creutzfeldt-Jakob
Disease Surveillance? A Study in France from 2000 to 2008 Vol. 37, No. 3-4,
2011
Original Paper
Conclusions:These findings raise doubt about the possibility of a reliable
CJD surveillance only based on mortality data.
price of prion poker goes up again $$$
Monday, June 11, 2012
Guidance for Industry Draft Guidance for Industry: Amendment to “Guidance
for Industry: Revised Preventive Measures to Reduce the Possible Risk of
Transmission of Creutzfeldt-Jakob Disease and Variant Creutzfeldt-Jakob Disease
by Blood and Blood Products”
Sunday, June 3, 2012
A new neurological disease in primates inoculated with prion-infected blood
or blood components
PLEASE REMEMBER ;
The Akron, Ohio-based CJD Foundation said the Center for Disease Control
revised that number in October of 2004 to about one in 9,000 CJD cases per year
in the population group age 55 and older.
HAVE YOU GOT YOUR CJD QUESTIONNAIRE ASKING REAL QUESTIONS PERTAINING TO
ROUTE AND SOURCE OF THE TSE AGENT THAT KILLED YOUR LOVED ONE ???
if not, why not...
Friday, November 30, 2007
CJD QUESTIONNAIRE USA CWRU AND CJD FOUNDATION
Terry S. Singeltary Sr. on the Creutzfeldt-Jakob Disease Public Health
Crisis
full text with source references ;
Sunday, August 21, 2011
The British disease, or a disease gone global, The TSE Prion Disease (SEE
VIDEO)
U.S.A. HIDING MAD COW DISEASE VICTIMS AS SPORADIC CJD ? (see video at
bottom)
WHO WILL FOLLOW THE CHILDREN FOR CJD SYMPTOMS ???
Saturday, May 2, 2009
U.S. GOVERNMENT SUES WESTLAND/HALLMARK MEAT OVER USDA CERTIFIED DEADSTOCK
DOWNER COW SCHOOL LUNCH PROGRAM
OUR SCHOOL CHILDREN ALL ACROSS THE USA WERE FED THE MOST HIGH RISK CATTLE
FOR MAD COW DISEASE FOR 4 YEARS I.E. DEAD STOCK DOWNER CATTLE VIA THE USDA AND
THE NSLP.
WHO WILL WATCH OUR CHILDREN FOR THE NEXT 5+ DECADES ???
DID YOUR CHILD CONSUME SOME OF THESE DEAD STOCK DOWNER COWS, THE MOST HIGH
RISK FOR MAD COW DISEASE ???
you can check and see here ;
Tuesday, June 26, 2012
Creutzfeldt Jakob Disease Human TSE report update North America, Canada,
Mexico, and USDA PRION UNIT as of May 18, 2012
type determination pending Creutzfeldt Jakob Disease (tdpCJD), is on the
rise in Canada and the USA
Wednesday, May 16, 2012
Alzheimer’s disease and Transmissible Spongiform Encephalopathy prion
disease, Iatrogenic, what if ?
Proposal ID: 29403
Wednesday, April 25, 2012
USA MAD COW DISEASE AND CJD THERE FROM SINGELTARY ET AL 1999 – 2012
SUMMARY REPORT CALIFORNIA BOVINE SPONGIFORM ENCEPHALOPATHY CASE
INVESTIGATION JULY 2012
Summary Report BSE 2012
Executive Summary
layperson
Terry S. Singeltary Sr.
P.O. Box 42
Bacliff, Texas USA 77518
