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From: TSS ()
Subject: Re: BSE August 2006 Update on Feed Enforcement Activities to Limit the Spread of CVM UPDATE
Date: August 26, 2006 at 9:54 am PST

In Reply to: BSE August 2006 Update on Feed Enforcement Activities to Limit the Spread of CVM UPDATE posted by TSS on August 25, 2006 at 4:36 pm:

Controlling Risk From Bovine Spongiform Encephalopathy (BSE) BSE Milestones

1986 ............................

BSE is diagnosed in cattle in the UK.

1996 ............................

Variant Cruetzfeldt-Jakob Disease (vCJD) is diagnosed in humans in the UK,
and is epidemiologically linked to BSE.

1997 ............................

FDA adopted BSE feed rule.

2003 ............................

First BSE-infected cow is discovered in the United States.

2004 ............................

FDA and USDA issued advanced notice of proposed rulemaking concerning
regulatory measures that would strengthen the BSE feed rule.

2005 ............................

Second BSE-infected cow is discovered in the United States.

2005 ............................

FDA issued proposed amendment to BSE feed regulation to prohibit use of
certain high-risk cattle materials in food or feed of all animals.

THE CHALLENGE

The discovery of a second BSE-infected cow in the United States, during FY
2005, added to CVM’s challenge to
strengthen controls that will prevent the spread of BSE through feed. (The
first infected cow was discovered in December 2003.) BSE is a chronic,
degenerative, always fatal neurological disease affecting the central
nervous system of cattle.

FY 2005 Performance Goals

a Collect and analyze samples of domestic and imported feeds and feed
ingredients to monitor for the presence of prohibited animal proteins (in
conjunction with the Office of Regulatory Affairs [ORA]).

a Enforce the feed rule by conducting annual, targeted BSE inspections of
all known renderers and feed mills processing products containing prohibited
material (in conjunction with ORA).

a Allocate resources to extend BSE inspections into targeted segments of
industries (e.g., animal feed salvaging, distributors, retailers,
transporters, on-farm mixers, and ruminant feeds) subject to the BSE feed
regulation but previously minimally inspected (in conjunction with ORA).

a Allocate resources to accomplish up to 8,760 BSE inspections; 3,760
inspections will be conducted by FDA investigators, and up to 5,000
inspections (4,100 planned State contract inspections and 900 partnership
inspections) will be conducted by the States (in conjunction with ORA).

X Develop and initiate validation of an improved method for detecting
prohibited animal proteins in feed using Real-Time PCR (Polymerase Chain
Reaction) that will allow for the identification of up to four different
prohibited species in a single reaction. Adapt the Real-Time PCR methodology
to identify prohibited animal proteins in rendered materials from the
European Union as well as materials rendered in the United States.

The PCR method has not been completed. We were unable to satisfactorily work
out problems with the four species in one tube with a contracting firm in a
timely fashion. Therefore, we are moving toward development of a real-time
method with single species in a tube. Currently, we are conducting an
exhaustive in-house testing of this method prior to beginning a validation
study.

BSE belongs to a family of diseases known as transmissible spongiform
encephalopathies (TSEs) that include several ruminant and non-ruminant
animal diseases. Laboratory and epidemiological evidence strongly suggests
that people can contract a human TSE, variant Cruetzfeldt-Jakob Disease
(vCJD), by consuming food from BSE-infected cattle. In the absence of
adequate controls, BSE could spread among the cattle population through feed
ingredients derived from infected cattle.

FY 2005 Accomplishments

We continued to provide the expert scientific knowledge and review on BSE
for the Agency. Much of our effort during the year focused on follow-up
action related to the second BSE case, assistance to the Federal government
in efforts related to the international marketing of U.S. beef, and steps
toward strengthening our BSE feed regulation. We made significant progress
in developing analytical methods that will enhance efficient, effective
compliance with the regulation. Following are highlights of some of our
achievements during the year just ended, as we focus on the FDA strategic
priorities of protecting consumer and animal health, and efficient risk
management.

RESPONDING TO THE SECOND BSE CASE IN THE UNITED STATES

In June 2005, the U.S. Department of Agriculture informed FDA that a cow in
Texas tested positive for BSE. The animal’s carcass was disposed of by
incineration, and did not enter the human food or animal feed chains.
Although the animal posed no risk to the animal feed supply, FDA, along with
USDA’s Animal and Plant Health Inspection Service, the Texas Animal Health
Commission, and the Texas Feed and Fertilizer Control Service, conducted a
feed investigation with two main objectives.

The first objective was to identify all protein sources in the animal’s feed
history that could potentially have been the source of the BSE agent. The
investigation found that no feed products used on the farm since 1997 had
been formulated to contain prohibited mammalian protein. The second
objective was to verify that cattle of interest leaving the herd after 1997
were rendered at facilities that were in compliance with FDA’s 1997
regulation that prohibits most mammalian protein in the feed for ruminants
(the BSE feed rule). This part of the investigation involved visits to nine
slaughter plants and eight rendering plants. The investigation found that
all rendering plants were operating in compliance with the BSE feed rule. A
review of the inspection history of each of these rendering firms found no
previous violations.

STRENGTHENING THE BSE FEED REGULATION

As the fiscal year came to a close, FDA proposed new measures to help
further protect consumers against the agent thought to cause BSE. The Agency
proposed to amend the BSE feed regulation to prohibit from use in the food
or feed of all animals certain cattle materials that have the highest risk
of carrying the BSE-infectious agent. The materials include:

*

the brains and spinal cords from cattle 30 months of age and older;
*

the brains and spinal cords from cattle of any age not inspected and
passed for human consumption;
*

the entire carcass of cattle not inspected and passed for human
consumption if the brains and spinal cords have not been removed;
*

tallow that is derived from the materials prohibited by this proposed
rule if the tallow contains more than 0.15 percent insoluble impurities; and
*

mechanically separated beef that is derived from the materials prohibited by
the proposed rule.

All of the proposed prohibitions, except for those related to tallow, have
applied to ruminant feed since the regulation’s adoption in 1997.

The removal of high-risk materials from all animal feed – including pet
food – will protect against the transmission of the agent of BSE that could
occur either through cross-contamination of ruminant feed with non-ruminant
feed or feed ingredients during feed manufacture and transport, or through
intentional or unintentional misfeeding of non-ruminant feed to ruminants on
the farm. Although overall compliance with the BSE feed rule has been high,
inspections have revealed some instances of cross-contamination and failure
to label prohibited materials properly. Financial incentives for misfeeding
exist in some circumstances. Regulatory action has been taken where problems
were found, but preemptive action to avoid violations seems prudent.

We believe that the additional measures will make an already small risk even
smaller. The proposed changes to the regulation build on a series of
firewalls that include the BSE feed regulation, which prohibits the use of
certain mammalian-origin proteins in ruminant feed (e.g., for cattle and
sheep), but allows these materials to be used in feed for non-ruminant
species.

STRENGTHENING THE BSE FEED REGULATION INSPECTIONAL EFFORTS

Inspections

Utilizing resources allocated by CVM in FY 2005 to the Office of Regulatory
Affairs, FDA exceeded its goal and conducted 4,001 inspections. The States,
based on available inventory of firms conducted an additional 3,309
inspections for a total of 7,310. The inspections conducted by FDA and the
States included the inspection, analysis, and follow-up of all 580 firms
known to process products containing prohibited material. That total also
included as many inspections of related industry firms (e.g., animal feed
salvagers, distributors, and retailers) as could feasibly be accomplished.
We also worked with ORA in the collection, analysis and follow-up of 838
domestic and 458 imported product samples. In summary, we believe that the
FY 2005 performance goals related to BSE inspections were accomplished.

Training

CVM continued to provide BSE inspection training to FDA investigators as
well as State inspectors during the fiscal year. We conducted several
one-day training courses across the country, including courses in Florida,
North Carolina, Idaho, and Oklahoma. CVM also had opportunities in other
settings, including meetings of State feed control officials, to assist in
training or to provide an update on BSE activities.

INTERNATIONAL BSE ACTIVITIES

We have provided personnel and expertise on BSE and animal feed issues to
the U.S. Department of Agriculture in support of its efforts to reopen
foreign markets for U.S. beef. Center representatives met during FY 2005
with numerous groups from foreign governments to discuss the BSE inspection
program and our feed regulations. Most of these meetings were stimulated by
the decisions of a number of nations, following the discovery of the first
BSE-infected cow in the U.S., to stop purchasing beef originating from the
United States. These countries have been evaluating the regulation of beef
and animal feed in the United States, to guide their decisions on reopening
their markets to

U. S. beef. During FY 2005, we met in the United States with delegations
from Korea, Taiwan, Ireland, and a number of Eastern European countries, and
we accompanied U. S. delegations on trips to Canada, Japan, Korea, and
China.

DEVELOPING ANALYTICAL METHODS FOR DETECTING PROHIBITED MATERIALS

The availability of practical, validated methods to detect protein from
different animal species could improve effectiveness and efficiency in the
enforcement of the BSE feed regulation. Methods to detect mammalian protein
have been available for some time, but because not all mammalian proteins
are prohibited from ruminant feed, methods are needed to identify protein
from prohibited species such as cattle. The development and use of such
methods would be consistent with the FDA strategic plan priority of
targeting limited resources for maximum protection.

Real-Time PCR Methods

During FY 2005, we continued the development of real-time polymerase chain
reaction (PCR) methods for identification of appropriate species – bovine,
sheep/goat, and deer/elk. (“Real-time” means that we can detect the presence
of prohibited material as the reaction is taking place, so we do not have to
further process the sample.) The method will detect prohibited materials
prepared by either U.S. or European Union rendering processes. After
discussions with analysts in FDA’s Office of Regulatory Affairs who conduct
PCR analyses of animal feed, we modified our research on the real-time PCR
method. We are working now to simplify the entire procedure from start to
finish, thus making it very user friendly. We have identified primers4 for
the appropriate species and are working on combining all components of the
procedure, excluding the actual instrumentation part, into a single package.
Once we have completed the in-house evaluation of this revised PCR method,
we will conduct a validation study in preparation for use in the field. The
Agency is currently using a traditional PCR method (not a real-time PCR) to
support positive findings of animal protein by the microscopy method.

Commercial Diagnostic Kits

Commercially available diagnostic test kits marketed for the detection of
ruminant proteins in animal feed can be important tools for surveillance and
quality assurance. FDA does not have preclearance authority over such kits,
but undertook evaluation of two of the kits in FY 2004, to assess the
accuracy of claims made. We completed the evaluation of a third such kit in
FY 2005. Like the two diagnostic tests previously evaluated, this test was
much less sensitive than the methods the Agency uses (microscopy and PCR)
for analysis of animal feed. We also identified labeling issues that need to
be addressed. An evaluation of a fourth commercially available diagnostic
test will be initiated in FY 2006.

4 PCR primers are short sections of DNA that mark the beginning and end of
the section of the DNA template that is being copied by the PCR process. If
they are specific to a known sequence of DNA nucleotides, PCR primers can
identify the species from which the tested material is derived.


snip...end

http://www.fda.gov/cvm/FY2005AnnualReport.htm#BSE


TSS

----- Original Message -----
From: "Terry S. Singeltary Sr."
To:
Sent: Tuesday, August 08, 2006 9:21 PM
Subject: BSE Ruminant and Mammalian mad cow protein in commerce USA 2000 -
2006 compliments FDA/USDA/TSS et al 'THE BIGGER PICTURE'


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

Subject: BSE Ruminant and Mammalian mad cow protein in commerce USA 2000 -
2006 compliments FDA/USDA/TSS et al 'THE BIGGER PICTURE'
Date: August 8, 2006 at 6:43 pm PST
BSE Ruminant and Mammalian mad cow protein in commerce USA 2000 - 2006
compliments FDA/USDA/TSS et al 'THE BIGGER PICTURE'


30936 Federal Register / Vol. 62, No. 108 / Thursday, June 5, 1997 / Rules
and Regulations

21 CFR Part 589

Substances Prohibited From Use in

Animal Food or Feed; Animal Proteins

Prohibited in Ruminant Feed; Final Rule

http://www.fda.gov/cvm/Images/6597bse.pdf


BSE/Ruminant Feed Ban Inspections

FOOD AND DRUG ADMINISTRATION

COMPLIANCE PROGRAM GUIDANCE MANUAL

http://www.fda.gov/ohrms/dockets/98fr/03d-0498-gdl0001.pdf


1999 - 2000 CVM BSE

CVM Update
(THIS IS NOT A JOKE...TSS)
May 13, 1999

BSE FEED REGULATION TEAM TO RECEIVE VICE PRESIDENTIAL AWARD

On May 14, the Food and Drug Administration (FDA)/Association of American
Feed Control Officials (AAFCO) Bovine Spongiform Encephalopathy Feed
Regulation Team will be honored with Vice President Al Gore's Hammer Award.
The BSE Feed Regulation Team is comprised of employees from FDA's Center for
Veterinary Medicine (CVM) and Office of Regulatory Affairs (ORA), and AAFCO,
an organization that includes officials from all States and the Federal
government who are responsible for enforcing the laws regulating the
production, labeling, distribution, and/or sale of animal feeds.

The Award will be presented by Yetta Lyle who will be representing the Vice
President's National Partnership for Reinventing Government at CVM's 1999
Honor Awards Ceremony. The Awards ceremony will be held from 9:30 - 11:30
a.m., at the Gaithersburg Hilton Hotel, Grand Ballroom, 620 Perry Parkway,
in Gaithersburg, MD. The 17 team members who spearheaded the effort will be
honored.

The award citation reads, "For making a significant contribution to reducing
the possibility of bovine spongiform encephalopathy (BSE, or 'mad cow
disease') becoming established and spread in the U.S." The Team used an
innovative education-oriented partnership program to enforce a FDA
regulation designed to control BSE. Compliance rates for the first
inspections of all but one industry segment equaled or exceeded 75 percent.
Compliance rates at follow-up inspections should approach the goal of 100
percent compliance, based on the enforcement strategy developed and updated
jointly by the partners. Independent research has shown that major industry
adjustments have been made to facilitate compliance with the regulations.
FDA and State inspectors have conducted an unprecedented number of
education-oriented inspections; a reinvented approach to doing inspections
that has resulted in 70 percent savings in the cost of inspections,
amounting to $1.3 million in Fiscal Year 1999.

The Hammer Award is the down-to-earth symbol of the National Partnership for
Reinventing Government, a five-year old, major initiative to make the
government work better for less. The program honors Federal employees and
their partners who have joined forces to streamline procedures, put
consumers first, and help build a better and more cost-effective government.

In addition to a plain carpenter's hammer, the award includes a ribbon and
the Vice President's note of appreciation, all set in an aluminum frame.
Also, every Team member will receive a personal certificate of appreciation
with Al Gore's signature and a lapel hammer pin.


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

Issued by:
FDA, Center for Veterinary Medicine,
Office of Management and Communications, HFV-12
7519 Standish Place, Rockville, MD 20855
Telephone: (301) 827-3800 FAX: (301) 827-4065
Internet Web Site: http://www.fda.gov/cvm


http://www.fda.gov/cvm/CVM_Updates/HAMMERUP.html


PRODUCT
Loweís 40% Hog Concentrate - swine feed for mixing grower and
finisher rations, in 50-pound bulk bags.
Recall #V-057-0.
CODE
All codes between August 1, 1999 and November 23, 1999.
MANUFACTURER
Lowe's Feed & Grain, Inc., Bowling Green, Kentucky.
RECALLED BY
Manufacturer, by letter dated November 18, 1999, and by
telephone. Firm-initiated recall complete.
DISTRIBUTION
Ohio.
QUANTITY
12.46 tons were distributed.
REASON
Product contained protein derived from mammalian tissue and
according to regulation must bear the statement "Do not feed to
cattle or other ruminants" on the label. This regulation is
designed to prevent the establishment and amplification of BSE
through feed. This statement does not appear on the label.


http://www.fda.gov/bbs/topics/ENFORCE/ENF00623.html

2001


October 30, 2001

RUMINANT FEED (BSE) ENFORCEMENT ACTIVITIES


http://www.fda.gov/cvm/CVM_Updates/bseoctup.htm


October 10, 2001

FDA HOLDING PUBLIC HEARING ON RUMINANT FEED (BSE) RULES

The Food and Drug Administration (FDA) is holding a public hearing to
solicit information and views on its present animal feeding regulation
"Animal Proteins Prohibited in Ruminant Feed" -- Code of Federal
Regulations, Title 21, Part 589.2000. The purpose of the rule is to help
prevent the establishment and amplification of bovine spongiform
encephalopathy (BSE) in U.S. cattle herds through feed and thereby help
minimize any risks from BSE to animal or human health.

FDA recognizes that new information has emerged on BSE and variant
Creutzfeldt-Jakob Disease (vCJD) since the rule went into effect in 1997.
Therefore, FDA is requesting information and views from individuals and
organizations on the present rule and whether changes in the rule or other
additional measures are necessary. The Agency is particularly interested in
soliciting comments and views from individuals, industry, consumer groups,
health professionals, and researchers with expertise in BSE and related
animal and human diseases. ...snip

http://www.fda.gov/cvm/CVM_Updates/part15.htm

September 25, 2001

BSE INSPECTION CHECKLIST AVAILABLE ON THE CVM INTERNET HOME PAGE


FDA's Center for Veterinary Medicine (CVM) has made available the Bovine
Spongiform Encephalopathy (BSE) Inspection Checklist on the Center's Home
Page on the Internet. This checklist is to be used by Federal and State
inspectors to determine compliance with FDA's ruminant feed (BSE)
regulations, Code of Federal Regulations, Title 21, Part 589.2000.
This rule, that prohibits the use of most mammalian protein in feeds for
ruminant animals, was implemented to prevent the establishment and
amplification of BSE through feed in the United States. The rule became
effective on August 4, 1997. Inspections of over 10,000 renderers, feed
mills, ruminant feeders, and others (such as protein blenders) have been
conducted to determine compliance with the BSE feed regulations. The
majority of these inspections (around 80%) were conducted by State officials
and the remainder by FDA. A checklist has been used to record information on
the compliance with the rules. The checklist that is being made available on
the CVM Home Page is a revised version intended for use in future
inspections.

http://www.fda.gov/cvm/CVM_Updates/bsecheck.htm

CVM Update
July 7, 2001

RUMINANT FEED (BSE) ENFORCEMENT ACTIVITIES


http://www.fda.gov/cvm/CVM_Updates/bse72001.htm

CVM Update
March 23, 2001

RUMINANT FEED (BSE) ENFORCEMENT ACTIVITIES

http://www.fda.gov/cvm/CVM_Updates/bsemar3.htm

CVM Update
January 10, 2001

UPDATE ON RUMINANT FEED (BSE) ENFORCEMENT ACTIVITIES

http://www.fda.gov/cvm/CVM_Updates/bseup.htm

RECALLS AND FIELD CORRECTIONS: VETERINARY MEDICINE - CLASS
II_______________________
PRODUCT
Red Cell, Iron Rich Homogenized, Yucca Flavored Vitamin-Iron-Mineral
Supplement for all classes of horses. For Animal Use Only. NET
CONTENTS: 1 GALLON. HORSE HEALTH Products, A Division
of Farnam Companies, Inc. PO Box 34820, Phoenix AZ 85067-4820,
Recall # V-002-2.
Redglo, EQUICARE (brand), Homogenized Energy Building Liquid Multi-
Vitamin Supplement for Horses. EQUICARE PRODUCTS, A
Division of Farnam Companies, Inc., PO Box 34820, Phoenix, AZ,
Recall # V-003-2.
CODE
All codes.
RECALLING FIRM/MANUFACTURER
Farnam Companies, Inc., Phoenix, Arizona, sent a recall letter dated
March 8, 2001, to all distributors via regular first class mail. Firm
initiated recall is ongoing.
REASON
The products contain protein material derived from
bovine mammalian tissues; however, the bags are not labeled with the
required BSE cautionary statement.
VOLUME OF PRODUCT IN COMMERCE
14,000 to 15,000 gallons.
DISTRIBUTION
Nationwide.http://www.fda.gov/bbs/topics/ENFORCE/2001/ENF00719.html


RECALL NUMBER, PRODUCT AND CODE:
Ruminant Custom Mix Feeds:
V-388-1 "Beef Feed" manufactured with Buckeye 40% Beef
Finisher Pellets, Item 40950.
V-389-1 "Rita's Goat Feed" manufactured with Buckeye 39% Lamb
Conc. Pellets, Item 41250.
V-390-1 "Calf-Beef/Dairy Feed" manufactured with Buckeye 32%
Golden Expectation Pellets, Item 42150
V-391-1 "Feed with Vitamin A" manufactured with Buckeye
Vitamin A-30, Item 1614
V-392-1 "Feed/A-D-E Premix" manufactured with Buckeye A-D-E
Mix, Item 152850
V-409-1 "Calf Feed" manufactured with Buckeye 32% Calf Grower
Concentrate, Item 42350

Non-Ruminant Custom Mix Feeds:
V-393-1 "40% Poultry Feed" manufactured with Buckeye 40%
Poultry Concentrate Crumbles, Item 12100
V-394-1 "40% Hog Feed" manufactured with Buckeye 40% Gro'Em
Lean, Item 20550
V-395-1 "Horse Premium Mixer" manufactured with Buckeye 32%
Premium Mixer Pellets, Item 38000
Code: All bulk custom mix feeds manufactured prior to April 20, 2001.
The customer invoices indicate the type of Buckeye supplement used in the
bulk feed.
REASON:
The bulk custom mix feeds were prepared with ruminant feed supplements
recalled by Buckeye Nutrition due to contamination with protein derived
from mammalian tissues. The non-ruminant bulk custom mix feeds were not
labeled with the required BSE caution statement "Do Not Feed to Cattle or
Other Ruminants."
MANUFACTURER/RECALLING FIRM:
Ferrin Cooperative Equity Exchange, Inc., Carlyle, Illinois
RECALLED BY:
The firm , by letter beginning on June 28, 2001.
FIRM INITIATED RECALL:
Ongoing.
DISTRIBUTION:
IL
QUANTITY:
169 tons of ruminant feeds and 27 tons of non-ruminant feeds

END OF ENFORCEMENT REPORT FOR October 10,
2001.


####

http://www.fda.gov/bbs/topics/ENFORCE/2001/ENF00714.html


RECALL NUMBER, PRODUCT AND CODE:
Recall # Product
V-397-1 Hyland Floating Fishfood, in 50 pound bags
V-398-1 Endurance Plus Extrude Horse Feed, in 50 pound bags
V-399-1 Seminole Ultra Bloom Horse Feed, in 50 pound bags
V-400-1 Wheat Flakes, extruded product in bulk, not bagged
V-401-1 Corn Flakes, extruded product in bulk, not bagged
V-402-1 Capt. Crunch, extruded product in bulk, not bagged
V-403-1 Green Corn Puffs, extruded product in bulk, not bagged
V-404-1 Orange Corn Puffs, extruded product in bulk, not
bagged
V-405-1 Whole Kernel Corn, in 50 pound bags, unlabeled
V-406-1 Soybean Meal, in bulk, not bagged, unlabeled
ALL CODES
REASON:
The animal feed products may contain proteins derived from mammalian
tissues.
The products are not labeled with the required BSE caution statement "Do Not
Feed to Cattle or Other Ruminants."
MANUFACTURER/RECALLING FIRM:
The Hyland Company, Ashland, Kentucky
RECALLED BY:
Manufacturer, by telephone on July 25, 2001, and letters on July 31, 2001.
FIRM INITIATED RECALL:
Complete
DISTRIBUTION:
KY, GA, NC, FL WV
QUANTITY:
568 tons


END OF ENFORCEMENT REPORT FOR August 29, 2001.

####


http://www.fda.gov/bbs/topics/ENFORCE/2001/ENF00708.html

RECALL NUMBER, PRODUCT AND CODE:
V-385-1 - Rock-N-Rooster Competition Blend, lots:
K01611 K01719 K01912 K01916 K02012 K02015
K02214 K02310 K02314 K02318 K02519 K02615
K02917 K03018 K03114 K03215 K03316 K03413
K10116 K10119 K10219 K10313 K10417 K10610
K10714 K10914 K11115 K11214 K11412 K11512
K02019 K02813 K03516 K10616 K11515
V-386-1 - Rock-N-Rooster Premium Five-Grain Scratch, lots:
K01611 K01715 K01718 K01812 K01912 K01916
K02012 K02015 K02019 K02117 K02214 K02310
K02318 K02513 K02518 K02710 K02719 K02813
K02910 K02917 K03011 K03018 K03114 K03215
K03413 K03418 K03516 K03517 K10012 K10013
K10115 K10119 K10219 K10310 K10312 K10410
K10611 K10614 K10616 K10713 K10810 K10812
K10914 K10919 K11012 K11114 K11115 K11216
K11213 K11214 K11315 K11412 K11419 K11512
K01918 K02314 K02814 K03316 K101121
K10510 K10819 K11211 K11515
V-387-1 - Rock-N-Rooster Maintainer, lots:
K01611 K01719 K01812 K01912 K01916 K01918
K02015 K02117 K02314 K02318 K02513 K02519
K02813 K02814 K02917 K03011 K03018 K03114
K03316 K03413 K03418 K03514 K03516 K03517
K10116 K10119 K10219 K10312 K10417 K10512
K10617 K10714 K10810 K11012 K11115 K11211
K11315 K11512 K11515 K02012 K02615 K03215
K10012 K10616 K11214
REASON:
The product contained prohibited material; however, the bags were not
labeled
with the required BSE cautionary statement.
MANUFACTURER/RECALLING FIRM:
Southern States Cooperative, Inc., Richmond, Virginia
RECALLED BY:
The recalling firm ceased distribution on June 6, 2001, and notified feed
mill
distributors and distribution points by e-mail on June 6 and 7, 2001, to
stop
sale and notify their retail customers of the stop sale and provide further
instructions for relabeling of any of the affected inventory. The firm sent
labels with the cautionary statement to their consignees.
FIRM INITIATED RECALL:
ONGOING
DISTRIBUTION:
KY, VA, MD, WV, NC, SC, GA, AL, DE, FL, MS and TN
QUANTITY:
962 tons


END OF ENFORCEMENT REPORT FOR August 1, 2001.


http://www.fda.gov/bbs/topics/ENFORCE/2001/ENF00704.html


RECALL NUMBER, PRODUCT AND CODE:
V-353-1 through V-370-1,
Chicken feed products:
Recall # Tag # Product
V-353-1 587 B. Challenger Scratch Feed
V-354-1 588 B. 18% Gamebird Conditioner
V-355-1 2060 B. Kickin' Chicken Premium Game Cock Feed
V-356-1 2066 B. Kickin' Chicken Premium Gamebird 16%
V-357-1 586 B. Scratch Grain
V-358-1 2051 B. Pit Performer 17%
V-359-1 575 B. Classic Yard Feed
V-360-1 576 Eliminator Maintainer
V-361-1 578 Eliminator Conditioner
V-362-1 586 Producer Scratch Grain
V-363-1 4587 Producer 12% Gamebird Yard Feed
V-364-1 2065 Cleveland Trophy Cock Feed
V-365-1 80181AAA Consolidated Hen Scratch
V-366-1 2051 B&B Maintenance 12
V-367-1 2052 B&B Conditioner 14
V-368-1 2050 B&B Scratch 10
V-369-1 4590 Kingsport Original Prater Mix
V-370-1 2062 PC 10 (unlabeled bags)
ALL CODES
The "B" indicates that the Burkmann Feeds brand name is listed on the tag
labels. The suspect products are also bagged and distributed under the
following private labels:
Producer Feeds, Louisville, Kentucky
Kingsport Milling, Kingsport, Tennessee
Consolidated Nutrition, L.C., Omaha, Nebraska
B&B Feeds, Knoxville, Tennessee
Eagle Roller Mill Co., Inc., Shelby, North Carolina
Central Farm Supply of Kentucky, Inc., Louisville, Kentucky
REASON:
The chicken feed products may contain proteins derived from mammalian
tissues.
The products are not labeled with the required BSE caution statement "Do Not
Feed to Cattle or Other Ruminants."
MANUFACTURER/RECALLING FIRM:
Burkmann Feeds, London, Kentucky
RECALLED BY:
On May 5, 2001, the firm mailed recall letters with attached BSE
sticker-labels
to all customers outside the state of Kentucky. The recall notices were
hand-
delivered to customers within the state of Kentucky by Burkmann's Sales
Representatives. Customers were asked to complete and return a recall
response
form that was included with each letter documenting the numbers of bags and
varieties of products for which the customers affixed the BSE
sticker-labels.
The firm expanded their recall on May 10, 2001, and mailed recall letters
with
BSE labels and response forms to the affected customers.
FIRM INITIATED RECALL:
Ongoing
DISTRIBUTION:
KY, GA, NC, TN, VA
QUANTITY:
933 tons
_______________________________
RECALL NUMBER, PRODUCT AND CODE:
V-377-1, Renner’s brand 45% meat and bone meal, packed in 100 pound bags.
REASON:
The product contained protein material derived from bovine mammalian
tissues;
however, the bags are not labeled with the required BSE cautionary
statement.
MANUFACTURER/RECALLING FIRM:
F. W. Renner & Sons, Inc., Canton, Ohio
RECALLED BY:
The recalling firm contacted the consignees by telephone on June 19, 2001.
FIRM INITIATED RECALL:
Complete
DISTRIBUTION:
OH
QUANTITY:
2,500 lbs
_______________________________
RECALL NUMBER, PRODUCT AND CODE:
V-378-1 to V-384-1, RenPro 58% (brand name) swine and poultry feeds in bulk,
as
follows:
V-378-1 - Poultry Layer #215 - guaranteed analysis 15% crude protein, 3%
crude
fat, and 3.5% crude fiber.
V-379-1 - Poultry Layer #216 - guaranteed analysis 16% crude protein, 3%
crude
fat, and 3.5% crude fiber.
V-380-1 - Poultry Layer #217 - guaranteed analysis 17% crude protein, 3%
crude
fat, and 3.5% crude fiber.
V-381-1 - Poultry Layer #218 - guaranteed analysis 18% crude protein, 3%
crude
fat, and 3.5% crude fiber.
V-382-1 - Poultry Layer #219 - guaranteed analysis 19% crude protein, 3.5%
crude
fat, and 4% crude fiber.
V-383-1 - Poultry Prelay #115 - guaranteed analysis 16% crude protein, 3%
crude
fat, and 5% crude fiber.
V-384-1 - Poultry Developer #110 - guaranteed analysis 14% crude protein, 3%
crude fat, and 5.5% crude fiber.
MANFACTURER:
Esbenshade Mills, Mount Joy, PA
RECALLED BY:
On 5/24/01, the manufacturer notified their customers of the labeling
requirement via letter.
FIRM INITIATED RECALL:
Complete
DISTRIBUTION:
PA
QUANTITY:
None. The product turn over is two weeks or less.


END OF ENFORCEMENT REPORT FOR July 25, 2001.


http://www.fda.gov/bbs/topics/ENFORCE/2001/ENF00703.html

RECALL NUMBER, PRODUCT AND CODE:
V-371-1, Tender Lean/Shelled Corn Cattle Feed Mix, a custom
animal feed mix, packed in 80 LB bags. CODES: None. The bags are
unlabeled. The feed was manufactured on 5/14/2001.
REASON:
The cattle feed (for ruminant animals)may contain protein derived from
mammalian tissues.
MANUFACTURER/RECALLING FIRM:
Champaign Landmark, Inc., Urbana, Ohio
RECALLED BY:
On 5/24/2001, the firm's Feed Manager personally visited the sole
farmer/consignee, at which time, he hand-delivered the firm's recall
letter.
FIRM INITIATED RECALL:
Complete
DISTRIBUTION:
Ohio
QUANTITY:
2,000 LBS


END OF ENFORCEMENT REPORT FOR July 11, 2001.


http://www.fda.gov/bbs/topics/ENFORCE/2001/ENF00701.html

RECALL NUMBER, PRODUCT AND CODE:
V-352-1, Bulk Lamb Meal, All lots of bulk lamb meal shipped by the recalling
firm
REASON:
The product is not labeled with the required caution statement “Do not feed
to
Cattle or other Ruminants.”
MANUFACTURER/RECALLING FIRM:
International Proteins Corporations (IPC), St. Paul MN
RECALLED BY:
Recalling Firm, Revised labeling by letter on April 17, 2001.
FIRM INITIATED RECALL:
Ongoing.
DISTRIBUTION:
MN, IL, MO, AR and TX
QUANTITY
3,094 tons

END OF ENFORCEMENT REPORT FOR July 04, 2001.


http://www.fda.gov/bbs/topics/ENFORCE/2001/ENF00700.html


PODUCT:
Bulk Lamb Meal. Recall Number V-052-1.
CODES:
All lots of bulk lamb meal shipped by the recalling firm.
MANUFACTURER:
International Proteins Corporations (IPC), St. Paul, Minnesota.
RECALLED BY:
Manufacturer, sent revised labeling in a letter on April 17, 2001. Firm
initiated recall is ongoing.
DISTRIBUTION:
MN, IL, MO, AK, TX.
QUANTITY:
3,094 tons.
REASON:
The product is not labeled with the required caution statement "Do Not Feed
to
Cattle or Other Ruminants."


END OF ENFORCEMENT REPORT FOR June 20, 2001.


http://www.fda.gov/bbs/topics/ENFORCE/2001/ENF00698.html

RECALLS AND FIELD CORRECTIONS: VETMED -- CLASS IIPRODUCT & 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.

http://www.fda.gov/bbs/topics/ENFORCE/2001/ENF00696.htmlhttp://www.fda.gov/bbs/topics/ENFORCE/2001/ENF00694.html
RECALLS AND FIELD CORRECTIONS: VETERINARY MEDS -- CLASS II
PRODUCT:
Buckeye 26% Hi Fat Swine Mix, Sandy Lake 40% Hog Supplement, 100 lb.
containers,
flexible plastic burlap bags. Recall #V-026-1.
CODE:
None are used.
MANUFACTURER:
Sandy Lake Mills, Sandy Lake, PA.
RECALLED BY:
Manufacturer, by telephone and visit. Firm initiated recall complete.
DISTRIBUTION:
Pennsylvania.
QUANTITY:
Seven containers, each weighing 100 pounds.
REASON: The product contains prohibited material (ruminant
animal proteins) used as an ingredient in the finished product swine feed.
The
product is not labeled with the required caution statement "Do Not Feed to
Cattle or Other Ruminants."
________
PRODUCT:
Custom Vaquero Supplement for Cattle identified by Purina Mills. Recall
#V-027-
1.
CODE:
7V87.
MANUFACTURER:
Purina Mills, Inc., Gonzalez, Texas.
RECALLED BY:
Manufacturer, contacted the one consignee on January 17, 2001.
DISTRIBUTION:
Texas.
QUANTITY:
44,355 pounds.
REASON:
The ruminant feed product contains meat and bone meal (MBM) of bovine
origin.http://www.fda.gov/bbs/topics/ENFORCE/2001/ENF00692.html PRODUCT:
a) Manna Pro Floating Fish Food for Catfish . Recall #V-028-1;
b) Manna Pro Floating Fish Food - 26% For All Freshwater Fish.
Recall #V-029-1.
Both are packaged in 50 pound, plastic-lined, paper sacks.
CODE:
a) 10160164, 12090164, 01050264, 03020264, and 03140264;
b) 09110164, 09190164, 09230164, 10090164, 10160164, 11170164,
12090164 and 3200264.
MANUFACTURER:
Doane Pet Care, Brentwood, Tennessee.
RECALLED BY:
Manufacturer, by telephone on March 26, 2001. Firm-initiated recall
complete.
DISTRIBUTION:
California, Pennsylvania, Ohio, Kansas, Colorado, Georgia, and Florida.
QUANTITY:
27,300 pounds of Catfish Food and 86,100 pounds of Freshwater Fish.
REASON:
The products, which contain meat by-products, were shipped without the
required BSE warning
label.http://www.fda.gov/bbs/topics/ENFORCE/2001/ENF00691.html


PRODUCT:
Buckeye 40% Poultry Concentrate. Recall #V-016-1.
CODES:
The bags are uncoded. Firm is recalling product manufactured since
December 1998; however, they are only completing field corrections on
product manufactured within the last six months (November 2000).
MANUFACTURER:
Yachere Feed, Inc. Rockwood, Pennsylvania.
RECALLED BY:
Manufacturer, by visit on 3/19/01 and 3/20/01. Firm-initiated recall
complete.
DISTRIBUTION:
Pennsylvania.
QUANTITY:
Nine containers, each weighing 100 pounds.
REASON:
The animal feed contains product derived from mammalian tissues and
must bear the statement "Do not feed to cattle or other ruminants"
on the label to prevent the establishment and amplification of BSE
through feed. This statement does not appear on the label.
________
PRODUCT:
"Our Own Pig & Hog Grower" hog feed, packaged in 50 pound bags, with
paperboard tags sewn onto the bags. Recall #V-017-1.
CODES:
The bags are uncoded.
MANUFACTURER:
The Perry Coal and Feed Company, Perry, Ohio.
RECALLED BY:
Manufacturer, by telephone on March 22, 2001. Firm-initiated
recall complete.
DISTRIBUTION:
Ohio.
QUANTITY:
Approximately 350 pounds of hog feed (7/50 pound bags).
REASON:
The animal feed contains protein derived from mammalian tissues
and must bear the statement "Do not feed to cattle or other
ruminants" on the label to prevent the establishment and
amplification of BSE through feed. This statement does
not appear on the label.


http://www.fda.gov/bbs/topics/ENFORCE/2001/ENF00690.html


RECALLS AND FIELD CORRECTIONS: VETENIARY MED -- CLASS II

PRODUCT:
Custom Mixed Poultry Feed, bagged and sold as bulk,
unlabeled poultry feed. Recall #V-014-1.
CODE:
The bags are uncoded.
MANUFACTURER:
Western Reserve Farm Coop., Middlefield, Ohio.
RECALLED BY:
Manufacturer, by telephone on February 28, 2001.
Firm-initiated recall complete.
DISTRIBUTION:
Ohio.
QUANTITY:
Approximately 820 pounds.
REASON:
The animal feed contains product derived from mammalian
tissues and must bear the statement “Do not feed to cattle
or other ruminants” on the label to prevent the establishment
and amplification of BSE through feed. This statement does not
appear on the label.
________
PRODUCT:
Custom Mixed Poultry Feed, packaged in unlabeled 100
pound bags and sold in bulk. Recall #V-015-1.
CODE:
The bags are uncoded.
MANUFACTURER:
Medina Landmark, Inc., Medina, Ohio.
RECALLED BY:
Manufacturer, by telephone on March 5, 2001.
Firm-initiated recall complete.
DISTRIBUTION:
Ohio.
QUANTITY:
Approximately 900 pounds of feed (9/100 pound bags).
REASON:
The animal feed contains product derived from mammalian
tissues and must bear the statement “Do not feed to cattle
or other ruminants” on the label to prevent the establishment and
amplification of BSE through feed. This statement does
not appear on the label.


END OF ENFORCEMENT REPORT FOR APRIL 11, 2001.

http://www.fda.gov/bbs/topics/ENFORCE/2001/ENF00688.html


2002


To help prevent the establishment and amplification of

BSE through feed in the United States, FDA implemented

a final rule that prohibits the use of most mammalian

protein in feeds for ruminant animals. This rule, Title

21 Part 589.2000 of the Code of Federal Regulations, became

effective on August 4, 1997. To date, active monitoring

by the U.S. Department of Agriculture (USDA) has found

no cases of bovine spongiform encephalopathy (BSE) in

U.S. cattle. This is an update on FDA enforcement activities

regarding the ruminant feed (BSE) regulation.

FDA’s enforcement plan for the ruminant feed regulation

includes education, as well as inspections, with FDA

taking compliance actions for intentional or repeated noncompliance.

FDA’s Center for Veterinary Medicine (CVM)

has assembled data from the inspections that have been

conducted AND whose final inspection report has been

submitted to CVM (i.e., “inspected/reported”) as of March

11, 2002. There is a lag time between the completion of

an inspection and the submission of a final inspection report

to CVM. This lag period includes the time required to

conduct quality assurance on the report and to evaluate

the findings before a final report is submitted.

As of March 11, CVM had received inspection reports

covering inspections (both initial inspections and re-inspections)

of 10,458 different firms. The majority of these in-

RUMINANT FEED (BSE) ENFORCEMENT ACTIVITIES

http://www.fda.gov/cvm/Documents/MayJune.pdf


July/August 2002

The following individuals/firms received warning

letters for violations related to 21 CFR Part 589.2000 –

Animal Proteins Prohibited in Ruminant Feed. This regulation

is intended to prevent the establishment and

REGULATORY ACTIVITIES

by Karen A. Kandra

amplification of Bovine Spongiform Encephalopathy

(BSE):

• Jeffrey T. Buck, Owner, All American Feed & Tractor,

Sandpoint, ID

• Kenneth M. Van Dyke, President, Van Dyke Grain

Elevators, Inc., North Plains, OR

• Philip C. Anderson, General Manager, Darling International,

Inc., Tacoma, WA

Violations included failure to maintain sufficient

records and written procedures to prevent cross-contamination;

failure to keep written procedures for cleaning

out or flushing equipment after mixing feeds containing

prohibited material; failure to provide written

procedures for separating products that contain or

may contain prohibited material from ingredients

used in ruminant feeds, from the time of receipt until

the time of shipment; and, failure to label meat

and bone meal with the required cautionary statement

“Do Not Feed to Cattle or Other Ruminants.”


snip...

http://www.fda.gov/cvm/Documents/JulyAugust.pdf

November 12, 2002

MATERIAL FROM CWD-POSITIVE ANIMALS SHOULD NOT BE USED FOR ANIMAL FEED

This CVM Update has been _withdrawn_ by Draft Guidance for Industry #158:
Use of Material from Deer and Elk in Animal Feed | doc| | pdf |, May 14,
2003

See CVM Update Draft Guidance on Use of Material from Deer and Elk in Animal
Feed Available for Comment; CVM Updates on Deer and Elk in Animal Feed
Withdrawn.


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


http://www.fda.gov/cvm/CVM_Updates/CWdup.htm


2003D-0186
Guidance for Industry: Use of Material From Deer and Elk In Animal Feed

EMC 1
Terry S. Singeltary Sr.
Vol #:
1

http://www.fda.gov/ohrms/dockets/dailys/03/Jun03/060903/060903.htm

CVM Update
Clarification of FDA Position on Use In Animal Feed of Material From Certain
Free Range Deer and Elk

This CVM Update has been withdrawn by Draft Guidance for Industry #158: Use
of Material from Deer and Elk in Animal Feed | doc| | pdf |, May 14, 2003.

See CVM Update Draft Guidance on Use of Material from Deer and Elk in Animal
Feed Available for Comment; CVM Updates on Deer and Elk in Animal Feed
Withdrawn.


http://www.fda.gov/cvm/CVM_Updates/CWDNOV21.htm

CONTAINS NON-BINDING RECOMMENDATIONS

158

Guidance for Industry

Use of Material from Deer and Elk in Animal Feed

Comments and suggestions regarding this guidance should be sent to the
Division of

Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers
Lane,

Room 1061, Rockville, MD 20852. Comments may also be submitted
electronically on

the Internet at http://www.fda.gov/dockets/ecomments. Once on this Internet
site, select

"[03D-0186][Use of Material from Deer and Elk in Animal Feed]" and follow
the

directions. All written comments should be identified with Docket No.
03D-0186.

For questions regarding this guidance, contact Burt Pritchett, Center for
Veterinary

Medicine (HFV- 222), Food and Drug Administration, 7500 Standish Place,
Rockville,

MD 20855, 301-827-0177. E-mail: bpritche@cvm.fda.gov

Additional copies of this guidance document may be requested from the
Communications

Staff (HFV-12), Center for Veterinary Medicine, Food and Drug
Administration, 7500

Standish Place, Rockville, MD 20855, and may be viewed on the Internet at

http://www.fda.gov/cvm.

U.S. Department of Health and Human Services

Food and Drug Administration

Center for Veterinary Medicine

September 15, 2003

CONTAINS NON-BINDING RECOMMENDATIONS

1

158

Guidance for Industry1

Use of Material from Deer and Elk in Animal Feed

I. Introduction

FDA’s guidance documents, including this guidance, do not establish legally

enforceable responsibilities. Instead, guidances describe the Agency’s
current

thinking on a topic and should be viewed only as recommendations, unless

specific regulatory or statutory requirements are cited. The use of the word

“should” in Agency guidances means that something is suggested or

recommended, but not required.

Under FDA’s BSE feed regulation (21 CFR 589.2000) most material from deer
and elk is

prohibited for use in feed for ruminant animals. This guidance document
describes FDA’s

recommendations regarding the use in all animal feed of all material from
deer and elk that

are positive for Chronic Wasting Disease (CWD) or are considered at high
risk for CWD.

The potential risks from CWD to humans or non-cervid animals such as poultry
and swine

are not well understood. However, because of recent recognition that CWD is
spreading

rapidly in white-tailed deer, and because CWD’s route of transmission is
poorly

understood, FDA is making recommendations regarding the use in animal feed
of rendered

materials from deer and elk that are CWD-positive or that are at high risk
for CWD.

II. Background

CWD is a neurological (brain) disease of farmed and wild deer and elk that
belong in the

animal family cervidae (cervids). Only deer and elk are known to be
susceptible to CWD

by natural transmission. The disease has been found in farmed and wild mule
deer,

white-tailed deer, North American elk, and in farmed black-tailed deer. CWD
belongs to

a family of animal and human diseases called transmissible spongiform
encephalopathies

1 This guidance has been prepared by the Division of Animal Feeds in the
Center for Veterinary Medicine

(CVM) at the Food and Drug Administration.

This guidance represents the Food and Drug Administration’s current

thinking on the use of material from deer and elk in animal feed. It does
not

create or confer any rights for or on any person and does not operate to
bind

FDA or the public. You can use an alternative approach if the approach

satisfies the requirements of applicable statutes or regulations. If you
want to

discuss an alternative approach, contact the FDA staff responsible for

implementing this guidance. If you cannot identify the appropriate FDA

staff, call the appropriate number listed on the title page of this
guidance.

CONTAINS NON-BINDING RECOMMENDATIONS

2

(TSEs). These include bovine spongiform encephalopathy (BSE or “mad cow”
disease)

in cattle; scrapie in sheep and goats; and classical and variant
Creutzfeldt-Jakob diseases

(CJD and vCJD) in humans. There is no known treatment for these diseases,
and there is

no vaccine to prevent them. In addition, although validated postmortem
diagnostic tests

are available, there are no validated diagnostic tests for CWD that can be
used to test for

the disease in live animals.

III. Use in animal feed of material from CWD-positive deer and elk

Material from CWD-positive animals may not be used in any animal feed or
feed

ingredients. Pursuant to Sec. 402(a)(5) of the Federal Food, Drug, and
Cosmetic Act,

animal feed and feed ingredients containing material from a CWD-positive
animal would

be considered adulterated. FDA recommends that any such adulterated feed or
feed

ingredients be recalled or otherwise removed from the marketplace.

IV. Use in animal feed of material from deer and elk considered at high risk
for CWD

Deer and elk considered at high risk for CWD include: (1) animals from areas
declared

by State officials to be endemic for CWD and/or to be CWD eradication zones;
and (2)

deer and elk that at some time during the 60-month period immediately before
the time of

slaughter were in a captive herd that contained a CWD-positive animal.

FDA recommends that materials from deer and elk considered at high risk for
CWD no

longer be entered into the animal feed system. Under present circumstances,
FDA is not

recommending that feed made from deer and elk from a non-endemic area be
recalled if a

State later declares the area endemic for CWD or a CWD eradication zone. In
addition,

at this time, FDA is not recommending that feed made from deer and elk
believed to be

from a captive herd that contained no CWD-positive animals be recalled if
that herd is

subsequently found to contain a CWD-positive animal.

V. Use in animal feed of material from deer and elk NOT considered at high
risk

for CWD

FDA continues to consider materials from deer and elk NOT considered at high
risk for

CWD to be acceptable for use in NON-RUMINANT animal feeds in accordance with

current agency regulations, 21 CFR 589.2000. Deer and elk not considered at
high risk

include: (1) deer and elk from areas not declared by State officials to be
endemic for

CWD and/or to be CWD eradication zones; and (2) deer and elk that were not
at some

time during the 60-month period immediately before the time of slaughter in
a captive

herd that contained a CWD-positive animal. ...snip ;


http://www.fda.gov/cvm/Guidance/guide158.pdf


CVM Update
April 15, 2002

RUMINANT FEED (BSE) ENFORCEMENT ACTIVITIES

http://www.fda.gov/cvm/CVM_Updates/bseap02.htm


RECALLS AND FIELD CORRECTIONS: VETERINARY MEDICINE -- CLASS II
_____________________________
PRODUCT
Land O'Lakes Farmland Feed 32% Grow Big Floater, For Catfish Grown In Ponds
or Artificial Culture Systems, packaged in 50-lb. bags, product #1960014,
contains animal protein products. Recall # V-003-3.
CODE
None.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Land O'Lakes Farmland Feed LLC, Arden Hills, MN, by fax on
August 21, 2002.
Manufacturer: Land O'Lakes Farmland Feed LLC, Kansas City, KS. FDA initiated
recall is complete.
REASON
Label lacks BSE warning statement.
VOLUME OF PRODUCT IN COMMERCE
Approx. 18,872/50-lb. bags.
DISTRIBUTION
KS, TX, CO, NE, IL, MO, IA, OK and SD


http://www.fda.gov/bbs/topics/enforce/2002/ENF00765.html

RECALLS AND FIELD CORRECTIONS: VETERINARY MEDICINE--CLASS II
_____________________________
PRODUCT
12% Horse Feed, packaged under the Griffith & Sons label, in 100 lb bags.
Recall # V-001-3.
CODE
The bags are not coded. All of their 12% Horse Feed product manufactured and
distributed from 5/14/2002 to 6/21/2002 is subject to this recall.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Griffith & Sons Feed and Farm Supply, Staffordsville, KY, by
telephone and visits on June 21, 2002.
Manufacturer: Griffith & Sons Feed and Farm Supply, Staffordsville, OH. Firm
initiated recall is complete.
REASON
The Horse Feed product contains beef protein and is not labeled with the
required BSE cautionary statement.
VOLUME OF PRODUCT IN COMMERCE
1,200 lbs (12 / 100 lb bags).
DISTRIBUTION
OH.


END OF ENFORCEMENT REPORT FOR OCTOBER 09, 2002

####

http://www.fda.gov/bbs/topics/enforce/2002/ENF00764.html

RECALLS AND FIELD CORRECTIONS: VETERINARY MEDICINE -- CLASS II
_______________________
PRODUCT
Product is flavor enhancer intended for use in pet food, labeled in part:
"8280 FLAVOR GENERATOR #1" packaged in 1,000 and 2,000 pound bags.
Recall # V-163-2.
CODE
All lots shipped prior to 04/09/02.
RECALLING FIRM/MANUFACTURER
Roche Vitamins, Inc., Fort Worth, TX, by telephone on April 5, 2002.
FDA initiated recall is complete.
REASON
Product contains beef protein but is not labeled with the warning
statement regarding prohibited for use as feed for ruminants.
VOLUME OF PRODUCT IN COMMERCE
680,200 lbs.
DISTRIBUTION
KS, CA, KY and IN.
http://www.fda.gov/bbs/topics/enforce/2002/ENF00762.html

RECALLS AND FIELD CORRECTIONS: VETERINARY MEDICINE -- CLASS
II_______________________
PRODUCT
Homestead Poultry Starter Grower Medicated 55 lb. bags. Recall # V-154-2.
CODE
Not coded.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Shur-Gain USA Inc., Elma, NY, by visit on June 24, 2002.
Manufacturer: Shur-Gain, St. Marys, Ontario, Canada.
FDA initiated recall is complete.
REASON
Contains ruminant proteins but lacks caution statement.
VOLUME OF PRODUCT IN COMMERCE
31 bags.
DISTRIBUTION
NY.
END OF ENFORCEMENT REPORT FOR AUGUST 14, 2002

####

http://www.fda.gov/bbs/topics/enforce/2002/ENF00756.html RECALLS AND FIELD
CORRECTIONS: VETERINARY MEDICINE -- CLASS II
_______________________
PRODUCT
UNLABELED hog feed in 100 lb. bags containing assorted grains (primarily
corn), and Miller's Hog Supplement 36% protein.
UNLABELED dairy feed in 100 lb. bags, contains assorted grains (primarily
corn), soybeans and molasses. Recall # V-142-2.
CODE
Not CODEd.
RECALLING FIRM/MANUFACTURER
Recalling Firm: R. B. Crowell & Sons/Thompson Grain, Inc., Manchester,
NY, by telephone on May 7 and 8, 2002.
Manufacturer: John R. Power, Palmyra, NY.
State initiated recall is complete.
REASON
Unlabeled animal feeds/possible cross contamination.
VOLUME OF PRODUCT IN COMMERCE
.75 tons per month.
DISTRIBUTION
NY.
_______________________
PRODUCT
Cereal Food Fines - Bulk PRODUCT. Recall # V-145-2.
CODE
All PRODUCT prior to October 2, 2001.
RECALLING FIRM/MANUFACTURER
Souder Feed & Grain Carlisle, PA, by letters dated October 9, 2001.
State initiated recall is ongoing.
REASON
PRODUCT doesn't bear caution statement - do not feed to
cattle or other ruminants.
VOLUME OF PRODUCT IN COMMERCE
6,141 tons.
DISTRIBUTION
MO, NY and PA.http://www.fda.gov/bbs/topics/enforce/2002/ENF00747.html
RECALLS AND FIELD CORRECTIONS: VETERINARY MEDICINE -- CLASS II
_______________________
PRODUCT
BioFlavor F2425, BioFlavor F21002 and BioFlavor C20058. The product,
packaged in 50 lb. bags, is labeled in part, " *** PALATABILITY ENHANCER
INTENDED FOR CAT FOOD USE AT LESS THAN 10% *** INGREDIENT LISTING: ***
Beef Broth *** ". Recall # V-140-2
CODE
Product Codes
F2425 107B-RB-1
107B-RB-2
149C
201D
202C
205D
210A
F21002 143B
143D
146D
144B
144D
139D
142D
150D
151D
152C
152D
201C
205C
206C
208A
211A
C20058 143D
144C
146C
208B
RECALLING FIRM/MANUFACTURER
Recalling Firm: Bioproducts, Inc., Fairlawn, OH, by telephone and letter
on April 5, 2002.
Manufacturer: Bioproducts, Inc., Aurora, MO.
Firm initiated recall is ongoing.
REASON
Animal feed product with beef protein does not contain required BSE
statement on labels.
VOLUME OF PRODUCT IN COMMERCE
354,150 lbs.
DISTRIBUTION
TX, KS, MO and MI.
_______________________
PRODUCT
Steamed Bonemeal in 50-lb. bags, product code C# 13581, packaged under
two different labels: Premium Steamed Bonemeal Manufactured by Buchheit
Premium Feeds, Perryville, MO, and Steamed Bonemeal Manufactured for
Siemer's Enterprises Inc., Teutopolis, IL.
Recall # V-141-2.
CODE
Not coded.
RECALLING FIRM/MANUFACTURER
Buchheit, Inc., Perryville, MO, by telephone on May 14, 2002.
FDA initiated recall is ongoing.
REASON
Label lacks BSE warning statement.
VOLUME OF PRODUCT IN COMMERCE
Approx. 902/50-lb. bags.
DISTRIBUTION
MO and IL.


END OF ENFORCEMENT REPORT FOR JUNE 5, 2002

####

http://www.fda.gov/bbs/topics/enforce/2002/ENF00746.html PRODUCT
The following 10 animal feed products were subject to this recall:
1- Sexton Brothers MIXED FEED-WM, Recall # V-019-2
2- Sexton Brothers 9% SWEET FEED, Recall # V-020-2
3- Sexton Brothers 13% SWEET FEED, Recall # V-021-2
4- Sexton Brothers WHEAT, Recall # V-022-2
5- Sexton Brothers 44% SOYBEAN MEAL, Recall # V-023-2
6- Sexton Brothers 14% GOAT FEED, Recall # V-024-2
7- Sexton Brothers WHEAT MIDDS, Recall # V-025-2
8- Sexton Brothers SHELLED CORN, Recall # V-026-2
9- Sexton Brothers OATS, Recall # V-027-2
10-Sexton Brothers 17% GOAT FEED, Recall # V-028-2
The feed products were packaged in 50 LB bags, under the Willard
Milling Company label.
CODE
No codes.
All recalled products that were distributed prior to July
30, 2001 are affected by this recall.
RECALLING FIRM/MANUFACTURER
Willard Milling, Inc. Willard, KY, by letter and telephone on July 30,
2001. State initiated recall is complete.
REASON
Products may contain protein derived from mammalian tissues.
VOLUME OF PRODUCT IN COMMERCE
Approx. 140 tons
DISTRIBUTION
OH, KY, IN, and WV.


END OF ENFORCEMENT REPORT FOR January 23, 2002


####


http://www.fda.gov/bbs/topics/enforce/2002/ENF00727.html

PRODUCT
The following custom mixed animal feeds are recalled ---
a) [non-ruminant]: Horse Feed, Hog Feed, and 14% Pig Feed.
Recall # V-157-2;
b) [ruminant]: Dairy Feed, Steer Feed, New Goat Feed, Cattle Feed, and
Beef Feed. Recall # V-158-2.
CODE
The product is coded only with the manufacturing date and invoice
numbers. All feed products manufactured and shipped since July 9, 2001
are affected by this recall.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Shepard Grain Company, Inc., Urbana, OH, by telephone on
January 11, 2002.
Manufacturer: Shepard Grain Company, Inc., W. Liberty, OH.
FDA initiated recall is complete.
REASON
Ruminant and non-ruminant animal feeds contain BSE prohibited material,
and are either misbranded or adulterated.
VOLUME OF PRODUCT IN COMMERCE
41,129 LBS (20.5 tons).
DISTRIBUTION
OH.


END OF ENFORCEMENT REPORT FOR AUGUST 28, 2002


http://www.fda.gov/bbs/topics/enforce/2002/ENF00758.html

2003

AS at August 8, 2006, the following rules to further enhance safety from
feed containing mad cow ingredients were never implemented, just more lies
and broken promises to cater to the industry. ...


Bovine Spongiform Encephalopathy

Bovine Spongiform Encephalopathy (BSE), commonly called “Mad Cow Disease” is
the name for a slowly progressive, degenerative, fatal disease affecting the
central nervous system of adult cattle. Since 1990, the U.S. Department of
Agriculture (USDA) has conducted aggressive surveillance of the highest risk
cattle going to slaughter in the United States, in which 10,000- 20,000
animals per year have been tested. To date, the only cow that has been found
to be affected with BSE was the one diagnosed with BSE in December 2003.

The exact cause of BSE is not known but it is generally accepted by the
scientific community that infectious forms of a type of protein, prions,
normally found in animals cause BSE. In cattle with BSE, these abnormal
prions initially occur in the small intestines and tonsils, and are found in
central nervous tissues, such as the brain and spinal cord, and other
tissues of infected animals experiencing later stages of the disease.

CVM and Ruminant Feed (BSE) Inspections

To prevent the establishment and amplification of Bovine Spongiform
Encephalopathy (BSE) through animal feed in the United States, FDA
implemented a final rule that prohibits the use of most mammalian protein in
feeds for ruminant animals. This rule, 21 CFR Part 589.2000 of the Code of
Federal Regulations, became effective on August 4, 1997(here called the
BSE/Ruminant Feed regulation.) Inspections of renderers, feed mills,
ruminant feeders, protein blenders, pet food manufacturers, pet food
salvagers, animal feed distributors and transporters, ruminant feeders, and
others have been conducted to determine compliance with the BSE/Ruminant
Feed regulations.


UPDATE: BSE Found in Washington State

USDA Reports Cow Tested Positive for BSE – FDA Sends Investigators
On December 23, 2003, the U.S. Department of Agriculture (USDA) announced
that a Holsteincow in the State of Washingtonhad tested presumptively
positive for bovine spongiform encephalopathy (BSE or “mad cow disease”).
Following this announcement, FDA dispatched several teams of investigators
to trace back and trace forward the potential involvement of any
FDA-regulated commodities. USDA, which is responsible for the safety of
certain meat and poultry products as well as animal health, led the
investigation of this BSE case.

FDA’s primary responsibility related to this investigation involved animal
feed, which most experts believe is the main way in which BSE is amplified
throughout cattle herds. BSE does not spread naturally from adult cow to
adult cow. FDA worked closely with USDA and state officials in this intense
investigation.

FDA’s “animal feed” rule, in place since 1997, is designed to prevent the
spread of BSE further throughout cattle herds. This regulation prohibits the
feeding of most mammalian protein to ruminant animals such as cows, sheep
and goats - the route of disease transmission that led to the epidemic of
BSE in the United Kingdom, beginning in the 1980’s.

A study published in 2001 by the HarvardCenterfor Risk Analysis identified
FDA’s animal feed rule as one of the primary safeguards against the
amplification of BSE in the U.S.cattle herd if a case were ever to occur in
the U.S.

FDA has vigorously enforced this rule. More than 99 percent of these
facilities are currently in compliance with the provisions of this rule to
protect the U.S.food supply and its cattle from the agent that causes BSE.

This one case of BSE does not mean that the U.S.food supply is any less safe
today than it was yesterday. Concerning the safety of milk, the scientific
data indicate that milk from BSE cows does not transmit BSE. National and
international public health organizations have consistently stated that milk
and milk products are safe regardless of whether the country producing them
has had cases of BSE.

On December 27, 2003, FDA announced that its investigators and inspectors
from the states of Washington and Oregon had located all of the
potentially-infectious product rendered from the one cow that tested
positive for BSE in Washington State. The rendering plants that processed
all the non-edible material from the BSE cow placed a voluntary hold on all
of the potentially-infectious product, none of which left the control of the
companies and entered commercial distribution. The firms, located in
Washington State and Oregon, assisted and cooperated fully with FDA’s
investigation.

FDA Emergency Operations Center

The FDA Emergency Operations Center (EOC), a branch of the OCM, is the
single point of coordination for the FDA's response to any BSE emergency.
The FDA EOC is the physical facility that serves as the central point for
the Agency's response activity. During a BSE emergency, the FDA EOC will
coordinate and report on all response activity and interagency
communication. The FDA EOC monitors BSE emergencies; triages complaints and
alerts; issues assignments to the field; coordinates responses; and
communicates with other federal, state, and local agencies as they request
technical and material support from the FDA.

The FDA EOC maintains contact with the Department of Health and Human
Services (HHS) Secretary's Command Center (SCC), CDC EOC, USDA/FSIS Office
of Food Security and Emergency Preparedness, and other EOCs, as appropriate.
The FDA EOC will continue to direct and monitor all FDA response activities
throughout the life cycle of an emergency.

New Measures to Prevent BSE

Several new public health measures will be implemented by FDA to strengthen
significantly the multiple existing firewalls that protect Americans from
exposure to the agent thought to cause bovine spongiform encephalopathy
(BSE, also known as mad cow disease) and that help prevent the spread of BSE
in U.S.cattle.

The existing multiple firewalls, developed by both the U.S.Department of
Agriculture (USDA) and HHS, have been extremely effective in protecting the
American consumer from exposure to BSE. The first firewall is based on
import controls started in 1989. A second firewall is surveillance of the
U.S.cattle population for the presence of BSE, a USDA firewall that led to
the finding of the BSE cow in December. The third firewall is FDA's 1997
animal feed ban, which is the critical safeguard to help prevent the spread
of BSE through cattle herds by prohibiting the feeding of most mammalian
protein to ruminant animals, including cattle.

The fourth firewall, recently announced by USDA, makes sure that no bovine
tissues known to be at high risk for carrying the agent of BSE enter the
human food supply regulated by USDA. The fifth firewall is effective
response planning to contain the potential for any damage from a BSE
positive animal, if one is discovered. This contingency response plan, which
had been developed over the past several years, was initiated immediately
upon the discovery of a BSE positive cow in Washington State December 23.

The new safeguards are science-based and further bolster these already
effective safeguards.

Specifically, HHS intends to ban from human food (including dietary
supplements), and cosmetics a wide range of bovine-derived material so that
the same safeguards that protect Americans from exposure to the agent of BSE
through meat products regulated by USDA also apply to food products that FDA
regulates.

FDA will also prohibit certain currently allowed feeding and manufacturing
practices involving feed for cattle and other ruminant animals. These
additional measures will further strengthen FDA's 1997 "animal feed" rule.

To implement these new protections, FDA will publish two interim final rules
that will take effect immediately upon publication, although there will be
an opportunity for public comment after publication.

The first interim final rule will ban the following materials from
FDA-regulated human food, (including dietary supplements) and cosmetics:

Any material from "downer" cattle. ("Downer" cattle are animals that cannot
walk.)
Any material from "dead" cattle. ("Dead" cattle are cattle that die on the
farm (i.e. before reaching the slaughter plant);
Specified Risk Materials (SRMs) that are known to harbor the highest
concentrations of the infectious agent for BSE, such as the brain, skull,
eyes, and spinal cord of cattle 30 months or older, and a portion of the
small intestine and tonsils from all cattle, regardless of their age or
health; and
The product known as mechanically separated beef, a product which may
contain SRMs. Meat obtained by Advanced Meat Recovery (an automated system
for cutting meat from bones), may be used since USDA regulations do not
allow the presence of SRMs in this product.
The second interim final rule is designed to lower even further the risk
that cattle will be purposefully or inadvertently fed prohibited protein. It
was the feeding of such protein to cattle that was the route of disease
transmission that led to the BSE epidemic in United Kingdomcattle in the
1980's and 1990's.

This interim final rule will implement four specific changes in FDA's
present animal feed rule. The rule:

Will eliminate the present exemption in the feed rule that allows mammalian
blood and blood products to be fed to other ruminants as a protein source.
Recent scientific evidence suggests that blood can carry some infectivity
for BSE.
Will also ban the use of "poultry litter" as a feed ingredient for ruminant
animals. Poultry litter consists of bedding, spilled feed, feathers, and
fecal matter that are collected from living quarters where poultry is
raised. This material is then used in cattle feed in some areas of the
country where cattle and large poultry raising operations are located near
each other. Poultry feed may legally contain protein that is prohibited in
ruminant feed, such as bovine meat and bone meal. The concern is that
spillage of poultry feed in the chicken house occurs and that poultry feed
(which may contain protein prohibited in ruminant feed) is then collected as
part of the "poultry litter" and added to ruminant feed.
Will ban the use of "plate waste" as a feed ingredient for ruminants. Plate
waste consists of uneaten meat and other meat scraps that are currently
collected from some large restaurant operations and rendered into meat and
bone meal for animal feed. The use of "plate waste" confounds FDA's ability
to analyze ruminant feeds for the presence of prohibited proteins,
compromising the Agency's ability to fully enforce the animal feed rule.
Will further minimize the possibility of cross-contamination of ruminant and
non-ruminant animal feed by requiring equipment, facilities or production
lines to be dedicated to non-ruminant animal feeds if they use protein that
is prohibited in ruminant feed. Currently, some equipment, facilities and
production lines process or handle prohibited and non-prohibited materials
and make both ruminant and non-ruminant feed -- a practice which could lead
to cross-contamination.
To accompany these new measures designed to provide a further layer of
protection against BSE, FDA plans to step up its inspections of feed mills
and renderers. FDA will itself conduct 2,800 inspections and will make its
resources go even further by continuing to work with state agencies to fund
3,100 contract inspections of feed mill and renderers and other firms that
handle animal feed and feed ingredients. Through partnerships with states,
FDA will also receive data on 700 additional inspections, for a total of
3,800 state contract and partnership inspections in 2004 alone, including
annual inspections of 100 percent of all known renderers and feed mills that
process products containing materials prohibited in ruminant feed.

UPDATE: The FDA also notes that in response to finding a BSE positive cow in
Washington state on December 23, it inspected and traced products at 22
facilities related to that positive cow or products from the cow, including
feed mills, farms, dairy farms, calf feeder lots, slaughter houses, meat
processors, transfer stations, and shipping terminals. Moreover, FDA
conducted inspections at the rendering facilities that handled materials
from the positive cow, and they were found to be fully in compliance with
FDA's feed rule.

To further strengthen protections for Americans, FDA/HHS intends to work
with Congress to consider proposals to assure that these important
protective measures will be implemented as effectively as possible.

FDA is also continuing its efforts to assist in the development of better
BSE science, to achieve the same or greater confidence in BSE protection at
a lower cost. For example, to enhance the ability of the USpublic health
system to detect prohibited materials in animal feed, FDA will continue to
support the development and evaluation of diagnostic tests to identify
prohibited materials. These tests would offer a quick and reliable method of
testing animal feeds for prohibited materials and for testing other products
for contamination with the agent thought to cause BSE.

Warning Letters Issued for Violations of BSE Regulations

On May 6, 2003, the FDA’s Minneapolis District Office issued a Warning
Letter to the President of Barr Animal Foods, Greenwood, Wisconsin. The FDA
conducted an inspection of the firm on April 8, 2003. The inspection
disclosed that the firm was not labeling their 50 pound blocks of frozen
beef and bulk loads of beef bone chips and rendering waste, intended for
animal feed with the required cautionary statement.

On August 25, 2003, the FDA’s Chicago District Office issued a Warning
Letter to the president of Lincoln Land Livestock Co., Inc., Mascoutah,
Illinois. On April 14 - 15, 2003, FDA conducted inspection of the animal
feed handling facility. The investigator found that products that contained
or may contain prohibited material failed to bear the caution statement, “Do
not feed to cattle or other ruminants.” The inspection also disclosed that
the firm did not 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.

On November 7, 2002, the FDA’s Dallas District Office issued a Warning
Letter to the President and Manager of Sunnymead Ranch, Inc., Idalou, Texas.
An FDA inspection of this feed mill found significant deviations from 21 CFR
589.2000. FDA’s inspection revealed that the firm manufactures feed for
sheep, that may contain residues of prohibited material. The sheep feed is
mixed in the same equipment that is used for mixing chicken feed containing
bovine meat and bone meal. In addition, the firm failed 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. The Warning Letter cautioned, “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.”

On May 22, 2003, the FDA’s New Orleans District Office issued a Warning
Letter to the Manager and Owner of Millstone Agri Distributors, Maryville,
Tennessee. An FDA inspection of the firm on February 13, 2003, found
significant deviations from the requirements of Title 21, Code of Federal
Regulations (21 CFR), Part 589.2000 - Animal Proteins Prohibited in Ruminant
Feed.

FDA’s investigation found the following violations of 21 CFR 589.2000:

Failure to separate the receipt, processing, and storage of products
containing prohibited material from products not containing prohibited
material;
Failure to establish written procedures, including clean-out and flushing
procedures, to avoid commingling and cross-contamination of common
equipment;
Failure to maintain records sufficient to track prohibited materials
throughout the receipt, processing, and distribution of products;
Failure to provide for measures to avoid commingling or cross-contamination
of feeds intended for ruminants and feeds intended for non-ruminants that
may contain prohibited materials;
Failure to label non-ruminant products with the required cautionary
statement “Do not Feed to Cattle or Other Ruminants.” The investigation
specifically found that dog food containing prohibited material was added as
an ingredient to the product “Premium Rooster Kicker.” The failure of these
feeds to bear the required BSE warning statement causes them to be
misbranded.
Consent Decree of Permanent Injunction Against X-Cel Feeds, Inc. Feed
Manufacturer Enjoined for Violations of the 1997 Animal Feed Rule

On July 11, 2003, FDA announced the filing of a Consent Decree of Permanent
Injunction against X-Cel, Feeds Inc., and individual officers based on
violations of the Federal Food, Drug, and Cosmetic Act.


X-Cel, a feed manufacturer headquartered in Tacoma, Washington, failed to
comply with FDA regulations (the 1997 Animal Feed Rule) designed to prevent
the establishment and spread of Bovine Spongiform Encephalopathy (BSE, also
known as "Mad Cow Disease") should it ever be found in the United States and
FDA regulations concerning the manufacture of medicated feeds.


The Department of Justice, Civil Division, Office of Consumer Litigation and
the United States Attorney's Office of the Western District of Washington
filed the Consent Decree in the United States District Court of the Western
District in Tacoma, Washington. It permanently enjoins X-Cel from
manufacturing animal feeds in violation of the Federal Food, Drug, and
Cosmetic Act and requires the firm, its officers, and employees to take
specific steps to avoid future violations including, implementing clean-out
procedures, obtaining protein supplier certifications and implementing
standard operating procedures for compliance until it satisfies FDA that it
has corrected its problems. ...


http://www.fda.gov/ora/about/enf_story/archive/2003/ch5/cvm1.htm

CVM Update
September 30, 2003

Update On Ruminant Feed (BSE) Enforcement Activities


http://www.fda.gov/cvm/CVM_Updates/BSEInspec03.htm

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.


http://www.fda.gov/bbs/topics/enforce/2003/ENF00796.html

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

###

http://www.fda.gov/bbs/topics/enforce/2003/ENF00781.html

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.

END OF ENFORCEMENT REPORT FOR APRIL 23, 2003

###

http://www.fda.gov/bbs/topics/enforce/2003/ENF00792.html

_______________________________
PRODUCT
Steamed bone meal under the following labels:
1) Upco Steamed Bone Meal for Dogs, Cats, and Horses, packaged in 1-lb.
laminated pouches. 2) Benepet Steamed Bone Meal for Dogs, Cats, and Horses,
packaged in a 1-lb. plastic jar. Recall # V-295-3.
CODE
Upco brand: 010584, 012214, 012431,020672, 021124, 021834, 030616, 030901,
031293, 031301, 031401, 031981, 032382, 032626, 033136, 040171, 041316,
051635, 051991, 052320, 060505, 061115, 061783, 071006, 072328, 080212,
080826, 081621, 082217, 082274, 082683, 083095, 092381, 101613, 102772,
111087, 111201, 111694, 112112.
Benepet brand: 011004, 012435, 021191, 021374, 022111, 032203, 032821,
041432, 042611, 051181, 051992, 060371, 061129, 061203, 080816, 081185,
082802, 090422, 092295, 111202, 120572, 120612.
RECALLING FIRM/MANUFACTURER
Ameri-Pac, Inc., St. Joseph, MO, via telephone on June 27, 2003 and by
letter dated July 24, 2003. FDA initiated recall is complete.
REASON
Label lacks the cautionary statement "Do Not Feed to Cattle or Other
Ruminants."
VOLUME OF PRODUCT IN COMMERCE
23.3 tons Upco brand and 6.7 tons Benepet brand.
DISTRIBUTION
MO.

http://www.fda.gov/bbs/topics/enforce/2003/ENF00816.html

RECALLING FIRM/MANUFACTURER
Liver Powder, Super Gallo (brand), 16 oz. bag. Recall # V-005-4.
CODE
All codes.
RECALLING FIRM/MANUFACTURER
Thomas Veterinary Drug, Tolleson, AZ, by letter, on September 20, 2002.
Kentucky State initiated recall is complete.
REASON
Product is not labeled "Do not feed to cattle or other ruminants".
VOLUME OF PRODUCT IN COMMERCE
320.
DISTRIBUTION
AR, NC, WV, KY, LA, TN, HI, CA and AL.

http://www.fda.gov/bbs/topics/enforce/2003/ENF00828.html


2004


SELECTED FY 2004 ACCOMPLISHMENTS

USING RISK-BASED MANAGEMENT PRACTICES

Bovine Spongiform Encephalopathy (BSE)

• For fiscal year 2004, inspected over 6,806 renderers, feed mills, and
other firms,

including on-farm mixers and ruminant feeders, to determine compliance with
the

BSE feed regulations. At the end of the FY 2004, 17 firms were classified as
being

out of compliance at the time of their last inspection. Re-inspections of
these

facilities determined to be out of compliance with the BSE regulation are
still ongoing;

• FDA and state investigators specifically inspected a high-interest subset
of 645 firms

as part of our annual BSE performance goal feed inspections obligation. This
subset

represented 100 percent of all known renderers and feed mills processing
products

containing prohibited material;

• In July 2004, co-published with USDA an advanced notice of proposed
rulemaking

(ANPRM) requesting comments and scientific information on several additional

regulatory measures that would strengthen the feed regulation;

230

• Developed a real-time Polymerase Chain Reaction (PCR) based method capable
of

detecting cattle, swine, sheep, goats, horses, or deer material along with
poultry,

goose, and turkey for use in analyzing samples of animal feeds and feed
ingredients

in support of the animal protein prohibition;

• Evaluated two commercially available diagnostic test marketed to detect
mammalian

proteins in animal feed and feed ingredients;

• Issued 10 Warning Letters for animal proteins prohibited in ruminant feed,
and 15

class II recalls involving 15 firms and 25 products in response to
violations of the

BSE rule;

snip...full text ;


http://www.fda.gov/oc/oms/ofm/budget/2006/PDFs/Summary/Pages226thru251.pdf

Completed 50 feed recall events. Thirty-tree of the 50 recall events were
feed related. Fifteen of the 33 recalls were related to BSE feed regulation;


http://www.fda.gov/cvm/CVMAccomp.htm

CVM Update
November 23, 2004

November 2004 Update on Ruminant Feed (BSE) Enforcement Activities


http://www.fda.gov/cvm/CVM_Updates/bseup112304.htm

CVM Update
July 29, 2004

July 2004 Update on Ruminant Feed (BSE) Enforcement Activities


http://www.fda.gov/cvm/CVM_Updates/bse72004up.htm


FDA Strategic Goal: Improving Product Quality, Safety, and Availability
through Better Manufacturing and Product Oversight
Bovine Spongiform Encephalopathy (BSE)
FDA animal feed experts joined the USDA team to provide technical expertise
in an audit conducted by the Canadian Food Inspection Agency in response to
the detection of two cases of BSE in Canada in 2004. Records were reviewed,
meetings were held and facilities across Canada were inspected. USDA issued
a report of its findings on February 25, 2005.
Issued 10 Warning Letters for animal proteins prohibited in ruminant feed,
and 15 class II recalls involving 15 firms and 25 products in response to
violations of the BSE rule.
Provided BSE inspection training to FDA investigators as well as state
inspectors during the fiscal year.
Provided personnel and expertise on BSE and animal feed issues to the U.S.
Department of Agriculture in support of its efforts to reopen foreign
markets for U.S. beef.
Continued the development of a real-time Polymerase Chain Reaction (PCR)
based method capable of detecting cattle, swine, sheep, goats, horses, or
deer material along with poultry, goose, and turkey for use in analyzing
samples of animal feeds and feed ingredients in support of the animal
protein prohibition. "Real-time" means that we can detect the presence of
prohibited material as the reaction is taking place, so we do not have to
further process the sample.
Completed the evaluation of a third commercially available diagnostic test
marketed for the detection of ruminant proteins in animal feed. Like the
other diagnostic tests previously evaluated, this test was much less
sensitive than the methods the Agency uses (microscopy and PCR) for analysis
of animal feed.
FDA implemented an advanced analytical procedure for detection of prohibited
material in animal feed into an assignment issued for 900 domestic and 900
import feed samples. This novel approach combines light microscopy with
polymerase chain reaction (PCR) to determine and detect DNA from ruminants
and non-ruminant mammalian species, supporting the BSE/Ruminant Feed Ban.
(Field Activity)
Following the finding of a BSE positive animal in Texas, FDA, USDA/APHIS,
the Texas Animal Health Commission, and the Texas Feed and Fertilizer
Control Service successfully conducted a feed investigation with two main
objectives. The first objective was to identify all protein sources in the
animal's feed history that could potentially have been the source of the BSE
agent. The second objective was to verify that cattle leaving the herd after
1997 that were identified by USDA/APHIS as animals of concern, such as
progeny and feed cohorts, were rendered at facilities in compliance with the
BSE/ruminant feed ban regulation. (Field Activity)
Awarded contracts with state and local governments to perform BSE, feed
manufacturers and illegal tissue residue inspections. Auditor training was
conducted for feed contracts. (Field Activity)
Reviewed and awarded Cooperative Agreement grants for BSE infrastructure
improvement in eight states. The Agency and the States maintained and
continued to develop new partnerships (e.g., BSE inspections) that have
contributed to the exchange of inspection and sampling data and have
facilitated the receipt of training and distribution of equipment to the
states. (Field Activity)
snip... full text ;

http://www.fda.gov/oc/oms/ofm/budget/2007/HTML/4AnimalDrugs.htm

CVM Update

July 9, 2004

FDA and USDA Request Comments and Scientific Information on Possible New BSE
Safeguards


Today, the Food and Drug Administration (FDA) and the U.S. Department of
Agriculture (USDA) announced that they will publish an advance notice of
proposed rulemaking ( ANPRM ) -- that requests comments and scientific
information on several additional measures related to animal feed under
consideration to help prevent the spread of bovine spongiform encephalopathy
(BSE, also known as “Mad Cow Disease”) in the United States. Some of these
measures include:

removing specified risk materials (SRMs) from all animal feed, including pet
food, in order to control the risks of cross contamination throughout feed
manufacture and distribution and on the farm due to misfeeding;

requiring dedicated equipment or facilities for handling and storing feed
and ingredients during manufacturing and transportation, to prevent cross
contamination;

prohibiting the use of all mammalian and poultry protein in ruminant feed,
to prevent cross contamination; and

prohibiting materials from non-ambulatory disabled cattle and dead stock
from use in all animal feed.

FDA has tentatively concluded that it should propose to remove SRMs from all
animal feed and is currently working on a proposal to accomplish this goal.
Comments on the issues raised by FDA in the ANPRM are due to FDA 30 days
after they publish in the Federal Register.

FDA’s 1997 ruminant feed rule has been a critical safeguard to stop the
spread of BSE through the U.S. cattle population by prohibiting the feeding
of most mammalian protein to cattle and other ruminant animals.

After a BSE-positive cow was detected in late December 2003, FDA announced
its plans to publish interim final rules on BSE that would take effect
immediately upon publication. For animal feed, FDA stated that the rule
would eliminate the present exemption in the ruminant feed rule that allows
mammalian blood and blood products to be fed to other ruminants as a protein
source, ban the use of "poultry litter" as a feed ingredient for ruminant
animals, and ban the use of "plate waste" as a feed ingredient for
ruminants. In addition, FDA said that to further minimize the possibility of
cross-contamination of ruminant and non-ruminant animal feed, the rule would
require equipment, facilities, or production lines to be dedicated to
non-ruminant animal feeds if they use protein that is prohibited in ruminant
feed.

On February 4, 2004 , shortly after FDA announced its plans to publish
interim final rules on BSE, an International Review Team (IRT) convened by
USDA issued a report and additional actions to protect the public against
BSE.

The proposed actions were significantly different from those FDA announced
in late January. Some of those proposals would make some of FDA’s actions
unnecessary. Rather than publishing a regulation that would take effect
automatically, USDA and FDA are soliciting public comment on the IRT’s
suggestions, as well as other measures designed to protect North America
against BSE. By seeking comment on the IRT’s recommendations, the agencies
hope to put into effect the most comprehensive, science-based improvements
possible.

http://www.fda.gov/cvm/CVM_Updates/bseanprm.htm

CVM Update
April 22, 2004

April 2004 Update on Ruminant Feed (BSE) Enforcement Activities

http://www.fda.gov/cvm/CVM_Updates/bse42004.htm

CVM Update
February 6, 2004

Update on Ruminant Feed (BSE) Enforcement Activities

http://www.fda.gov/cvm/CVM_Updates/BSE0206up.htm

RECALLS AND FIELD CORRECTIONS: VETERINARY MEDICINE-CLASS II
_______________________________
PRODUCT
Grand Vite, Nutritional Supplement, in tubs. 5, 10 and 25 pounds. Designed
for horses only. Recall # V-006-4.
CODE
Lot 1473.
RECALLING FIRM/MANUFACTURER
Grand Meadows, Inc., Orange, CA, by facsimile, on September 3, and September
5, 2003. FDA initiated recall is complete.
REASON
Product contains prohibited animal protein and is not labeled to prevent
feeding to ruminants.
VOLUME OF PRODUCT IN COMMERCE
131 packages of 5, 10 and 25 pounds.
DISTRIBUTION
Nationwide.

_______________________________
PRODUCT
a) Halter 15% Pig Meal, in 50 pound paper bags.
Recall # V-008-4;
b) Halter 18% Layer Pellet, in 50 pound paper bags.
Recall # V-009-4.
CODE
No codes.
RECALLING FIRM/MANUFACTURER
Halter Feed & Grain Inc., Massillon, OH, by telephone and letter on December
3, 8, and 10, 2003. FDA initiated recall is ongoing.
REASON
Animal feed that contains protein derived from mammalian tissue was not
labeled with the required BSE caution statement, "Do not feed to cattle and
other ruminants".
VOLUME OF PRODUCT IN COMMERCE
80 bags (4 tons).
DISTRIBUTION
OH.

END OF ENFORCEMENT REPORT FOR January 14, 2004

###


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

http://www.fda.gov/bbs/topics/enforce/2004/ENF00830.html

PRODUCT
ZuPreem Feline Diet, 14.0 oz cans for Non-Domesticated
Carnivores in the families Fedlidae, Canidea, and Hyenadea.
Recall # V-115-4.
CODE
6910 S1 SF01 military time of production: 06:05.
RECALLING FIRM/MANUFACTURER
Menu Foods, Inc., Pennsauken, NJ, by telephone on February 2, 2004. FDA
initiated recall is complete.
REASON
LACF Feiline Diet for non-domestic carnivores does not carry the BSE warning
statement.
VOLUME OF PRODUCT IN COMMERCE
1,620 cases.
DISTRIBUTION
KS.

_______________________________
PRODUCT
Product is a horse supplement packed into a 5 lb. Plastic
container with a yellow/green/red/brown label printed in
part "FORMULA: Each 5 pounds contains: Chondroitin Sulfate
27,000 mg D-Glucosamine HCL 100,000 mg Collagen hydrolyzed
27,000 MSM (methysulfonylmethane) 2,500 mg. Carti-Flex
COMPLEX net wt. 5 lbs, a concentrated natural joint
supplement containing Glucosamine HCL, Chondroitin sulfate,
Hydrolixed collagen and MSM". Recall # V-116-4.
CODE
All codes without the required cautionary statement are under recall.
RECALLING FIRM/MANUFACTURER
Interfarma Corporation, Miami, FL, by letters on February 4, 2004. FDA
initiated recall is ongoing.
REASON
This animal feed product does not contain the required BSE cautionary
statement: "Do Not Feed to Cattle or Other Ruminants".
VOLUME OF PRODUCT IN COMMERCE
80 cases 4-5 lb. Containers per case.
DISTRIBUTION
Venezuela, Nicaragua and Guatemala.

END OF ENFORCEMENT REPORT FOR MARCH 24, 2004

###


http://www.fda.gov/bbs/topics/enforce/2004/ENF00840.html

PRODUCT
Custom deer feed made for a Wisconsin farm. The product was in bags holding
about 40 pounds each. Recall # V-122-4.
CODE
1-30-04 on the product invoice and mixing record.
RECALLING FIRM/MANUFACTURER
Crivitz Feed Mill, Crivitz, WI, by telephone on February 20, 2004. Wisconsin
State initiated recall is complete.
REASON
The recalled deer feed contained steamed bone meal which is prohibited
material in feed for ruminants.
VOLUME OF PRODUCT IN COMMERCE
515 pounds.
DISTRIBUTION
WI.

>

END OF ENFORCEMENT REPORT FOR APRIL 7, 2004

###


http://www.fda.gov/bbs/topics/enforce/2004/ENF00842.html


PRODUCT
Custom dairy cattle feed made for two customers. Recall # V-123-4.
CODE
None.
RECALLING FIRM/MANUFACTURER
Maribel Grain Co., Maribel, WI, by visit on February 25, 2004. Firm
initiated recall is complete.
REASON
Possible cross contamination of cattle feed by steamed bone meal which is
prohibited material.
VOLUME OF PRODUCT IN COMMERCE
2,040 pounds.
DISTRIBUTION
WI.
______________________________


PRODUCT
B & G Seed Co., PIG GROWER, 50 lbs. Recall # V-126-4.
CODE
All.
RECALLING FIRM/MANUFACTURER
B & G Seed Company, Inc., Hull, GA, by telephone on March 30, 2004. Firm
initiated recall is ongoing.
REASON
Feed contains meat & bone meal (prohibited material), without the mandatory
ruminant warning on the label.
VOLUME OF PRODUCT IN COMMERCE
25/50 lb. bags.
DISTRIBUTION
GA.


http://www.fda.gov/bbs/topics/enforce/2004/ENF00843.html

_______________________________
PRODUCT
Cloverbelt 38% (38% protein concentrate for use in animal feed) in bulk.
Recall # V-127-4.
CODE
The recall product is a bulk feed commingled in a bin prior to sale - no lot
number.
RECALLING FIRM/MANUFACTURER
Cloverbelt Lumber & Feed Co., Conrath, WI, by telephone on February 23,
2004. Firm initiated recall is complete.
REASON
Possible cross contamination of the 38% protein concentrate with prohibited
material (bone meal).
VOLUME OF PRODUCT IN COMMERCE
18 tons.
DISTRIBUTION
WI.

END OF ENFORCEMENT REPORT FOR APRIL 28, 2004

###


http://www.fda.gov/bbs/topics/enforce/2004/ENF00845.html


PRODUCT
a) Bulk whole corn. Recall # V-150-4;
b) Bulk rolled corn. Recall # V-151-4;
c) Bulk rolled corn with added fat. Recall # V-152-4.
CODE
No coding information is used.
RECALLING FIRM/MANUFACTURER
Fresno Farming LlC, Traver, CA, by letters on June 30, 2004. Firm initiated
recall is ongoing.
REASON
Corm for feed may be contaminated with ruminant meat and bone meal.
VOLUME OF PRODUCT IN COMMERCE
Unknown.
DISTRIBUTION
Unknown.
____________________________


http://www.fda.gov/bbs/topics/enforce/2004/ENF00857.html

_______________________________
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.

PRODUCT
a) Premier Catfish Food, packaged in 50 pound bags (white paper
with an orange label). Recall #V-190-4;
b) Happy Fisherman Fish Food, pellet form, 50 pound bags.
Recall # V-191-4.
CODE
a) T1 Best By 08/27/05;
b) T21 Best By 11 DEC 05 and T11 Best By 02 OCT 05.
RECALLING FIRM/MANUFACTURER
Sunshine Mills, Inc., Tupelo, MS, by telephone beginning on April 14, 2004.
Firm initiated recall is complete.
REASON
The catfish food contains prohibited material (meat & bone meal) but does
not contain the cautionary statement, "Do not feed to cattle or other
ruminants" on the label.
VOLUME OF PRODUCT IN COMMERCE
1,092 ‚ 50 pound bags.
DISTRIBUTION
TX and MO.

http://www.fda.gov/bbs/topics/enforce/2004/ENF00869.html

RECALLS AND FIELD CORRECTIONS: VETERINARY MEDICINE - CLASS II
_______________________________
PRODUCT
Product is custom made steer/cattle feed packaged in 100 lb. poly bags. The
product has no labeling. Recall # V-001-5.
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 80 1û2 tons of steer/cattle feed.
DISTRIBUTION
OH.

_______________________________
PRODUCT
Product is custom made sheep/goat feed packaged in 100 lb. poly bags. The
product has no labeling. Recall # V-002-5.
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 8 tons.
DISTRIBUTION
OH.

_______________________________
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

###

http://www.fda.gov/bbs/topics/enforce/2004/ENF00870.html

RECALLS AND FIELD CORRECTIONS: VETERINARY MEDICINE -- CLASS II
_______________________________
PRODUCT
a) Hi-Tek Rations Horse Nuggets***Performance***
Net Wt. 40 lb (18.14 kg). Recall # V-006-5;
b) Hi-Tek Rations***Aqua-Tek***Quality Floating
Fish Food***Net Wt. 50 Lbs (22.68kg). Product
is packed in paper bags in amounts specified.
Recall # V-007-5.
CODE
a) Lot # 073128;
b) Lot #071202.
RECALLING FIRM/MANUFACTURER
HI-TEK Rations, Inc., Dublin, GA, by letter on September
17, 2004. Firm initiated recall is ongoing.
REASON
Product may contain prohibited ruminants; however, label does not have
required caution statement.
VOLUME OF PRODUCT IN COMMERCE
10 tons.
DISTRIBUTION
AL, GA, NC, SC, WV.


http://www.fda.gov/bbs/topics/enforce/2004/ENF00880.html


2005

VM Update
December 5, 2005

November 2005 Update on Feed Enforcement Activities to Limit the Spread of
BSE

http://www.fda.gov/cvm/CVM_Updates/BSE1105.htm

CVM Update
June 20, 2005

June 2005 Update on Feed Enforcement Activities to Limit the Spread of BSE

http://www.fda.gov/cvm/CVM_Updates/bse0605.htm

CVM Update
March 17, 2005

March 2005 Update on Feed Enforcement Activities to Limit the Spread of BSE

http://www.fda.gov/cvm/CVM_Updates/BSE0305.htm

PRODUCT
a) Bulk nonmedicated custom swine and poultry feeds,
Recall # V-006-6;
b) Bulk medicated swine and poultry feeds, Recall # V-007-6
CODE
N/A
RECALLING FIRM/MANUFACTURER
Gold Eagle Cooperative, Goldfield, IA, by telephone or visit beginning
August 30, 2005. Firm initiated recall is complete.
REASON
Swine and poultry feeds which may contain prohibited material are not
labeled with the warning statement not to feed to cattle or other ruminants.
VOLUME OF PRODUCT IN COMMERCE
Approx. 15,323.68 tons of nonmedicated and medicated feed
DISTRIBUTION
IA, GA, MD, and MN


http://www.fda.gov/bbs/topics/enforce/2005/ENF00925.html

RECALLS AND FIELD CORRECTIONS: VETERINARY MEDICINE -- CLASS II
______________________________
PRODUCT
Hydrolyzed Feather Meal, 50 lb. bags, Recall # V-109-5
CODE
Lot number: 11579
RECALLING FIRM/MANUFACTURER
Recalling Firm: Griffin Industries, Inc., Cold Springs, KY, by telephone on
September 2, 2005.
Manufacturer: Griffin Industries, Inc., Henderson, KY. Firm initiated recall
is ongoing.
REASON
Product may contain prohibited material and is not identified with the
cautionary statement: "Do not feed to cattle or other ruminants".
VOLUME OF PRODUCT IN COMMERCE
863/50 lb. bags
DISTRIBUTION
IN

END OF ENFORCEMENT REPORT FOR SEPTEMBER 28, 2005

###


http://www.fda.gov/bbs/topics/enforce/2005/ENF00919.html

2006

CVM Update
May 9, 2006

April 2006 Update on Feed Enforcement Activities to Limit the Spread of BSE

http://www.fda.gov/cvm/CVM_Updates/BSE0506.htm


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

New Orleans District
297 Plus Park Blvd.
Nashville, TN 37217

Telephone: 615-781-5380
Fax: 615-781-5391


May 17, 2006

WARNING LETTER NO. 2006-NOL-06

FEDERAL EXPRESS
OVERNIGHT DELIVERY

Mr. William Shirley, Jr., Owner
Louisiana.DBA Riegel By-Products
2621 State Street
Dallas, Texas 75204

Dear Mr. Shirley:

On February 12, 17, 21, and 22, 2006, a U.S. Food & Drug Administration
(FDA) investigator inspected your rendering plant, located at 509 Fortson
Street, Shreveport, Louisiana. The inspection revealed significant
deviations from the requirements set forth in Title 21, Code of Federal
Regulations, Part 589.2000 [21 CFR 589.2000], Animal Proteins Prohibited in
Ruminant Feed. This regulation is intended to prevent the establishment and
amplification of Bovine Spongiform Encephalopathy (BSE). You failed to
follow the requirements of this regulation; products being manufactured and
distributed by your facility are misbranded within the meaning of Section
403(a)(1) [21 USC 343(a)(1)] of the Federal Food, Drug, and Cosmetic Act
(the Act).

Our investigation found you failed to provide measures, including sufficient
written procedures, to prevent commingling or cross-contamination and to
maintain sufficient written procedures [21 CFR 589.2000(e)] because:

You failed to use clean-out procedures or other means adequate to prevent
carryover of protein derived from mammalian tissues into animal protein or
feeds which may be used for ruminants. For example, your facility uses the
same equipment to process mammalian and poultry tissues. However, you use
only hot water to clean the cookers between processing tissues from each
species. You do not clean the auger, hammer mill, grinder, and spouts after
processing mammalian tissues.

You failed to maintain written procedures specifying the clean-out
procedures or other means to prevent carryover of protein derived from
mammalian tissues into feeds which may be used for ruminants.

As a result . the poultry meal you manufacture may contain protein derived
from mammalian tissues prohibited in ruminant feed. Pursuant to 21 CFR
589.2000(e)(1)(i), any products containing or may contain protein derived
from mammalian tissues must be labeled, "Do not feed to cattle or other
ruminants." Since you failed to label a product which may contain protein
derived from mammalian tissues with the required cautionary statement. the
poultry meal is misbranded under Section 403(a)(1) [21 USC 343(a)(1)] of the
Act.

This letter is not intended as an all-inclusive list of violations at your
facility. As a manufacturer of materials intended for animal feed use, you
are responsible for ensuring your overall operation and the products you
manufacture and distribute are in compliance with the law. You should take
prompt action to correct these violations, and you should establish a system
whereby violations do not recur. Failure to promptly correct these
violations may result in regulatory action, such as seizure and/or
injunction, without further notice.

You should notify this office in writing within 15 working days of receiving
this letter, outlining the specific steps you have taken to bring your firm
into compliance with the law. Your response should include an explanation of
each step taken to correct the violations and prevent their recurrence. If
corrective action cannot be completed within 15 working days, state the
reason for the delay and the date by which the corrections will be
completed. Include copies of any available documentation demonstrating
corrections have been made.

Your reply should be directed to Mark W. Rivero, Compliance Officer, U.S.
Food and Drug Administration, 2424 Edenborn Avenue, Suite 410, Metairie,
Louisiana 70001. If you have questions regarding any issue in this letter,
please contact Mr. Rivero at (504) 219-8818, extension 103.

Sincerely,

/S

Carol S. Sanchez
Acting District Director
New Orleans District


http://www.fda.gov/foi/warning_letters/g5883d.htm


MAD COW FEED RECALL USA EQUALS 10,878.06 TONS NATIONWIDE
Sun Jul 16, 2006 09:22
71.248.128.67


RECALLS AND FIELD CORRECTIONS: VETERINARY MEDICINE -- CLASS II
______________________________
PRODUCT
a) PRO-LAK, bulk weight, Protein Concentrate for Lactating Dairy Animals,
Recall # V-079-6;
b) ProAmino II, FOR PREFRESH AND LACTATING COWS, net weight 50lb (22.6 kg),
Recall # V-080-6;
c) PRO-PAK, MARINE & ANIMAL PROTEIN CONCENTRATE FOR USE IN ANIMAL
FEED, Recall # V-081-6;
d) Feather Meal, Recall # V-082-6
CODE
a) Bulk
b) None
c) Bulk
d) Bulk
RECALLING FIRM/MANUFACTURER
H. J. Baker & Bro., Inc., Albertville, AL, by telephone on June 15, 2006 and
by press release on June 16, 2006. Firm initiated recall is ongoing.
REASON
Possible contamination of animal feeds with ruminent derived meat and bone
meal.
VOLUME OF PRODUCT IN COMMERCE
10,878.06 tons
DISTRIBUTION
Nationwide

END OF ENFORCEMENT REPORT FOR July 12, 2006

###

http://www.fda.gov/bbs/topics/enforce/2006/ENF00960.html


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


END OF ENFORCEMENT REPORT FOR AUGUST 2, 2006

###


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


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


END OF ENFORCEMENT REPORT FOR AUGUST 2, 2006

###


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


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

###


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


WE know now, and we knew decades ago, that 5.5 grams of suspect feed in
TEXAS was enough to kill 100 cows.


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

http://www.thelancet.com/journal/journal.isa


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.


http://www.bseinquiry.gov.uk/files/ws/s145d.pdf


2

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.


http://www.bseinquiry.gov.uk/files/ws/s147f.pdf


Re: BSE .1 GRAM LETHAL NEW STUDY SAYS via W.H.O. Dr Maura Ricketts

[BBC radio 4 FARM news]


http://www.maddeer.org/audio/BBC4farmingtoday2_1_03.ram


http://www.fda.gov/ohrms/dockets/ac/03/slides/3923s1_OPH.htm


2) Infectious dose:

To cattle: 1 gram of infected brain material (by oral ingestion)


http://www.inspection.gc.ca/english/sci/bio/bseesbe.shtml


Terry S. Singeltary Sr.

P.O. Box 42

Bacliff, Texas USA 77518


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

03-025IFA
03-025IFA-2
Terry S. Singeltary


Page 1 of 17

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

Sent: Thursday, September 08, 2005 6:17 PM

To: fsis.regulationscomments@fsis.usda.gov

Subject: [Docket No. 03-025IFA] FSIS Prohibition of the Use of Specified
Risk Materials for Human Food and Requirements

for the Disposition of Non-Ambulatory Disabled Cattle

Greetings FSIS,

I would kindly like to submit the following to [Docket No. 03-025IFA] FSIS
Prohibition of the Use of Specified Risk Materials for Human Food and

Requirements for the Disposition of Non-Ambulatory Disabled Cattle

THE BSE/TSE SUB CLINICAL Non-Ambulatory Disabled Cattle

Broken bones and such may be the first signs of a sub clinical BSE/TSE
Non-Ambulatory Disabled Cattle ;

SUB CLINICAL PRION INFECTION

MRC-43-00

Issued: Monday, 28 August 2000

NEW EVIDENCE OF SUB-CLINICAL PRION INFECTION: IMPORTANT RESEARCH

FINDINGS RELEVANT TO CJD AND BSE


Terry S. Singeltary Sr.

P.O. Box 42

Bacliff, Texas USA 77518

9/13/2005

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


Board Number: I-12
Title: Risk Factors for Animal Drug and Feed Products, Manufacturing
Processes and Facilities: Analysis of Recalls, 2000 – 2005

V. Wiles , E. A. Grove , K. B. Ekelman , CVM, FDA, Rockville, MD

Background: The Center for Veterinary Medicine (CVM) is developing a
risk-based inspection system to help ensure that regulatory resources are
focused on the animal feed and drug products, manufacturing processes and
facilities that pose the greatest risks to animal and human health. To help
identify risk factors for animal feed and drug products, manufacturing
processes and facilities, we analyzed 203 firm-initiated recalls of animal
drug and feed products from fiscal years 2000 through 2005. A recall is a
firm\'s removal or correction of a marketed product that FDA considers to be
in violation of the laws it administers.


Methods: We reviewed records for 203 firm-initiated recalls of animal drug
and feed products from fiscal years 2000 to 2005 to identify the types of
errors associated with recalled animal drug and feed products and to
determine which recalled products and errors were associated with the
highest levels of health hazards. The relative level of health hazard
attributed to each recalled product by FDA is reflected in an assigned
recall classification number (i.e., I, II, or III).


Results: Of the 203 firm-initiated recalls of animal drug and feed products
from fiscal years 2000 through 2005, 103 (approximately 51%) were for
non-medicated feeds, 33 (approximately 16%) were for medicated feeds, and 64
(approximately 32%) were for animal drugs. For recalls of non-medicated
feeds, 18% were classified as posing a high level of health hazard (recall
classification I) and 76% were classified as posing a moderate health hazard
(recall classification II). For recalls of medicated feeds, 13% were
classified as posing a high level of health hazard and 53% were classified
as posing a moderate level of health hazard. For recalls of animal drugs, 5%
were classified as posing a high level of health hazard and 42% were
classified as posing a moderate level of health hazard. The most common
errors identified for recalls of non-medicated feeds were those related to
the BSE rule. The most common errors identified for recalls of medicated
feeds were incorrect levels of drugs in feeds or feeding medicated feeds to
species or ages for which the drugs in the feeds were not approved. Other
errors associated with recalls of non-medicated and medicated feeds included
chemical or microbiological contamination, labeling errors, and general
manufacturing errors. The most common errors associated with recalls of
animal drugs were due to concerns about the drugs’ stability, sterility and
labeling.


Conclusions: CVM is using information from the analysis of the animal feed
and drug products associated with 203 firm-initiated recalls from fiscal
years 2000 through 2005 to help rank the relative risks from the products,
manufacturing processes and facilities.


Category: I. Risk Management, Risk Assessment,and Risk Communication for
Medical Products and Foods

http://www.accessdata.fda.gov/scripts/oc/scienceforum/sf2006/search/preview.cfm?abstract_id=838&backto=category


BAB = BORN AFTER BAN

BARB = BORN AFTER RUMINANT BAN

MAMB = BORN AFTER MAMMALIAN BAN

http://www.inspection.gc.ca/english/anima/heasan/disemala/bseesb/200503canada/fig3desce.html

NEW TSE TERM FOR FDA = BAWB I.E. 'BORN AFTER WHAT BAN' ;-(TSS)


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