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From: TSS (216-119-144-94.ipset24.wt.net)
Subject: US guideline aims to keep BSE agent out of animal feed (NOT)
Date: October 16, 2004 at 8:27 am PST

-------- Original Message --------
Subject: US guideline aims to keep BSE agent out of animal feed
Date: Sat, 16 Oct 2004 10:21:54 -0500
From: "Terry S. Singeltary Sr."
Reply-To: Bovine Spongiform Encephalopathy
To: BSE-L@UNI-KARLSRUHE.DE

US guideline aims to keep BSE agent out of animal feed

Amy L. Becker * Staff Writer

Oct 15, 2004 (CIDRAP News) The US Food and Drug Administration (FDA)
has announced a new guideline to prevent the use of cattle infected with
bovine spongiform encephalopathy (BSE) in any animal feed.

The use of any cattle parts in cattle feed has been banned since 1997,
but the Sep 30 recommendation, which took effect immediately, goes
further. It says that animal feed and feed ingredients with material
obtained from a BSE-positive animal are considered adulterated and
cannot be fed to any other animals.

"FDA recommends that any such adulterated feed or feed ingredients be
recalled or otherwise removed from the marketplace," the guideline says.
The FDA recommendation is not binding, and the agency said it would
continue to accept comments on it.

The FDA had also previously banned high-risk cattle tissues, or
"specified risk materials" (SRMs), from human food, food supplements,
and cosmetics. SRMstissues most likely to harbor the BSE agent in an
infected animalinclude the brain, skull, eyes, spinal cord, vertebral
column, and certain nerve bundles in cattle 30 months or older, plus the
tonsils and small intestine of all cattle.

Cattle can contract the prion disease BSE, one of several transmissible
spongiform encephalopathies, by eating feed containing material from
infected cattle. To prevent this, in 1997 the FDA banned the use of
ruminant animals in feed for ruminants. The rendering of cattle into
feed for nonruminant animals such as pigs and chickens remains a common
practice, but it has come under heightened scrutiny since the discovery
of one cow with BSE in Canada and one in the United States in 2003. The
concern is that contaminated material could be fed to cattle through
cross-contamination in feed plants or if feed intended for other animals
is given to cattle.

The latest recommendation is another government step to close gaps in
BSE prevention, said Will Hueston, DVM, PhD, director of the University
of Minnesota's Center for Animal Health and Food Safety in St. Paul.
Hueston was also part of an international review team (IRT) that
assessed BSE cases in the United States and Canada.

Canada and the United States may be close to taking what some view as a
key step in that process: banning SRMs from all animal feed.

FDA announced last July its intention to propose such a ban. Roughly
1,400 individuals and 100 industry groups sent letters during a
subsequent comment period, Linda Grassie, the communications director
for the FDA Center for Veterinary Medicine, said today.

Though a proposal is expected, Grassie said she doesnt know when it
will be issued.

Canada is also expected to take its rules a step further soon. The
Canadian government announced in July that it would ban the use of SRMs
in animal feed. One reason for the delay in implementing the Canadian
ban is the problem of determining how to safely dispose of those body
parts, officials said.

Officials reiterated that message recently in response to a new round of
questions raised by media reports over tracing of animal feed suspected
of containing materials from the BSE-infected cow found in Canada last
year.

Testing backlogs led to the infected animal being rendered, Sergio
Tolusso, feed program director for the Canadian Food Inspection Agency,
told Meatingplace.com last week. Investigators traced the feed, visited
200 farms and found several cases where cattle encountered the feed,
intended only for pigs and chickens. Three cattle farms were quarantined
and 63 cattle destroyed, according to the Canadian Broadcasting
Corporation.

Hueston said that ideally, Canada and the United States would develop
complementary response systems.

On both sides of the border were trying to close the gaps, he said.
But determining how much risks those gaps in rules represent and what to
do about tricky problems such as handling SRM disposal is still hotly
debated, he said.

The challenge becomes that there are lots of ways for the material to
get back into cattle feed, Hueston said.

See also:

Sept 30 FDA guidance on use of material from BSE-positive cattle in
animal feed
http://www.fda.gov/cvm/guidance/guide174.doc

Jul 9 Canadian announcement about SRMs in animal feed
http://www.inspection.gc.ca/english/corpaffr/newcom/2004/20040709e.shtml

Jul 9 CIDRAP News story, "FDA sets BSE-related rules but delays action
on feedtss


http://www.cidrap.umn.edu/cidrap/content/hot/bse/news/oct1504bse.html

Greetings,

> (FDA) has announced a new guideline to prevent the use of cattle
> infected with bovine spongiform encephalopathy (BSE) in any animal feed.


> The use of any cattle parts in cattle feed has been banned since 1997,
> but the Sep 30 recommendation, which took effect immediately, goes
> further. It says that animal feed and feed ingredients with material
> obtained from a BSE-positive animal are considered adulterated and
> cannot be fed to any other animals.
>

what a load. anything other than _mandatory_ will not work.

the 8/4/97 voluntary and partial ruminant to ruminant feed ban
was a joke, and it was/is no laughing matter, but the industry
is still laughing all the way to the bank...


Public Health Service
Food and Drug Administration

Dallas District
4040 North Central Expressway
Dallas, Texas 75204-3145


June 15, 2004

Ref: 2004-DAL-WL-18

WARNING LETTER

CERTIFIED MAIL
RETURNED RECEIPT REQUESTED

Mr. Patrick ORay, CEO & President
Specialty Brands, Inc.
P.O. Box 51467
Ontario, CA 91761-1057

Dear Mr. ORay:

An inspection of your food manufacturing facility located at 601 E. 3rd
Street, Lampasas, Texas, was conducted on February 26 and March 1, 2004
by Investigators from the Food and Drug Administration (FDA). The
inspection found significant deviations from the requirements set forth
in Title 21, Code of Federal Regulations, Section 589.2000 - Animal
Proteins Prohibited in Ruminant Feed (21 CFR 589.2000). This regulation
is intended to prevent the establishment and amplification of Bovine
Spongiform Encephalopathy (BSE).

Our inspection revealed that your firm sells its reduction stream waste
for use as animal feed and that it contracted with [redacted] to dispose
of this manufacturing process stream waste. [redacted] used this process
stream waste as animal feed for ruminants.

At the close of the inspection, a list of inspectional observations (FDA
483) was issued to your firm and discussed with Mr. Anthony E. Rocz,
Plant Manager. The following violation was observed during the inspection:

Products that contain protein derived from mammalian tissues and that
are intended for use in animal feed must be labeled with the cautionary
statement, Do not feed to cattle or other ruminants, as required by 21
CFR 589.2000(d)(1). For example, your firm manufactures Mexican
specialty food products such as tortillas, taquitos, and burritos that
contain beef. The production process stream waste includes ground corn,
product shells, and filling material, it is then placed in a
transportable bin for disposal by feeding to livestock. This
transportable waste bin did not bear the cautionary statement Do Not
Feed to Cattle or Other Ruminants.

Because your manufacturing stream waste did not bear this cautionary
statement, these products are misbranded within the meaning of section
403(a)(1) of the Federal Food, Drug, and Cosmetic Act.

You should know that this serious violation of the law may result in FDA
taking regulatory action without further notice to you. These actions
include, but are not limited to, seizure and/or injunction.

We are in receipt of a letter from Mr. Anthony E. ROCZ, Plant Manager,
dated March 2, 2004, in which he stated that your factory was under a
contract with [redacted] to remove and dispose of the production stream
waste generated at the factory since April 15, 2003. Our investigators
conveyed to Specialty Brands, Inc., on February 24, 2004, that the
disposal container was not properly labeled to indicate that the
material is not to be fed to cattle or other ruminants in accordance
with the BSE regulation. On February 26, 2004, our investigators
returned to your plant and conveyed to Mr. Rocz that earlier that
morning they observed cattle consuming the manufacturing stream waste
supplied by your firm to [redacted] The practice of supplying process
stream waste to [redacted] was indefinitely suspended on February 26,
2004. At that time, an alternative waste removal service was obtained to
dispose of the process stream waste in a sanitary landfill facility and
each load would be logged, a manifest detailing the pounds of process
waste disposed would be generated, and a certification of proper
disposal is to be provided for the record. This alternative stream waste
disposal process appears to be acceptable. Your letter also states that
your corporate Food Safety and Quality Assurance department is in the
process of drafting a corporate wide policy to ensure that all of your
factories are in compliance with the BSE regulation.

It is necessary for you to take prompt action on this matter now. Please
notify this office in writing within fifteen (15) working days from the
date you receive this letter of the specific actions you have taken to
prevent the recurrence of the violations, and when those actions were
taken or will be taken at your other corporate facilities having similar
disposal plans. Your reply should be sent to Edwin Ramos, Compliance
Officer, at the above stated address. If you have any questions
concerning this letter, you may contact Mr. Ramos at 214-253-5218.

Sincerely,

/s/

Michael A. Chappell
Dallas District Director

cc:
Specialty Brands, Inc.
Mr. Anthony E. Rocz, Plant Manager
601 E Third Street
Lampasas, TX 76550-2903

http://www.fda.gov/foi/warning_letters/g4898d.htm

Public Health Service
Food and Drug Administration

Dallas District
4040 North Central Expressway
Dallas, Texas 75204-3145


June 10, 2004

Ref: 2004-DAL-WL-17

WARNING LETTER

CERTIFIED MAIL
RETURNED RECEIPT REQUESTED

Mr. Jack Chapman, Owner
Chapman Ranch
11071 CR 1255
Lampasas, TX 76550

Dear Mr. Chapman:

An inspection of your ruminant feeding operation located at 11071 CR
1255, Lampasas, Texas, was conducted on February 26 and March 1, 2004 by
Investigators from the Food and Drug Administration (FDA). The
inspection found significant deviations from the requirements set forth
in Title 21, Code of Federal Regulations, Section 589.2000 - Animal
Proteins Prohibited in Ruminant Feed (21 CFR 589.2000). This regulation
is intended to prevent the establishment and amplification of Bovine
Spongiform Encephalopathy (BSE).

Our inspection revealed that you feed prohibited material, as defined by
21 CFR 589.2000(a), to ruminants. This prohibited material consists of
manufacturing process stream waste from [redacted] a manufacturer of
products such as fully cooked tacos, burritos, and taquitos that contain
beef. This manufacturing process stream waste contains meat products
that have been cooked and offered for human food but that have not been
further heat processed for feed. This failure to further heat process
the material causes the feed to be adulterated under section
402(a)(2)(C)(i) because it contains an unapproved food additive (i.e.,
the meat products that have not been further heat processed for feed).

At the close of the inspection, copies of the BSE Guidance documents 69,
70 and 76 were provided to you and further discussed. Also, you
previously received a copy of 21 CFR 589.2000, the BSE regulation, which
was again explained in more specific detail. You should know that this
serious violation of the law may result in FDA taking regulatory action
without further notice to you. These actions include, but are not
limited to, seizure and/or injunction.

It is necessary for you to take action on this matter now. Please send a
written response to this office within fifteen (15) working days from
the date you receive this letter. Your response should specifically
identify the actions you are taking to correct the violations and
provide specific timeframes for achieving compliance. Also, as part of
your written response, you should provide information regarding the
current feeding practices followed at your facility and information
pertaining to the planned marketing of your animals. Your reply should
be sent to Edwin Ramos, Compliance Officer, at the above stated address.
If you have any questions concerning this letter, you may contact Mr.
Ramos at 214-253-5218.

Sincerely,

/s/

Michael A. Chappell
Dallas District Director

horizonal rule

http://www.fda.gov/foi/warning_letters/g4899d.htm


Public Health Service
Food and Drug Administration

Atlanta District Office
60 8th Street, N.E.
Atlanta, Georgia 30309


June 10, 2004

VIA FEDERAL EXPRESS

WARNING LETTER
(04-ATL-13)

M. Dennis Burroughs
President
B & G Seed Company
591 Beck Road
Hull, Georgia 30646

Dear Mr. Burroughs:

An inspection of your feed mill was conducted by a Food and Drug
Administration (FDA) investigator on March 30, 2004. Our investigator
determined that you manufacture various products, including ruminant
feeds, which are animal feeds within the meaning of section 201(w) of
the Federal Food, Drug, and Cosmetic Act (the Act}. The inspection
revealed significant deviations from the requirements set forth in Title
21, Code of Federal Regulations (21 CFR), Part 589.2000
--Animal-Proteins Prohibited in Ruminant Feed. This regulation is
intended to prevent the establishment and amplification of Bovine
Spongiform Encephalopathy (BSE). The deviations cause the feed being
manufactured and distributed by your facility to be misbranded within
the meaning of sections 403(a)(1) of the Act.

The inspection revealed that not all of your feeds that contain protein
derived from mammalian tissues and that are intended for use in animal
feed (prohibited material) were labeled with the statement Do not feed
to cattle or other ruminants, as required by 21 CFR 589.2000(d)(1) and
(c)(1)(i). An example is your B & G Pig Grower. In addition, you have
routinely provided scrap or salvage dog food containing prohibited
material to be used as pig feed that was not labeled with the required
statement. In the case of bulk feed ingredients, the statement could
appear on the placard and invoice that accompany the shipment. The lack
of the required statement causes these feeds to be misbranded as defined
in section 403(a)(1) of the Act.

Our investigator also noted that you had failed to provide for adequate
measures to avoid commingling or cross-contamination of products that
contain or may contain prohibited material into feeds that may be used
for ruminants, as required under 21 CFR 589.2000(e)(1)(iii). You also
failed to establish written procedures for separating products which may
contain prohibited material from all other protein products from the
time of receipt until the time of shipment, as required under 21 CFR
589.2000(e)(1)(iv).

The above is not intended as an all-inclusive list of violations at your
firm. As a manufacturer of animal feeds, you are responsible for
ensuring that your overall operation and the products you manufacture
and distribute are in compliance with the law. We have included a copy
of the FDA Guidance for Industry 68 - Small Entities Compliance Guide -
Protein Blenders, Feed Manufacturers, and Distributors.

You should take prompt action to correct the above violations, and you
should establish procedures whereby such violations do not recur.
Failure to promptly correct these violations may result in regulatory
action without further notice, such as seizure and/or injunction.

You should notify this office, in writing, within fifteen (15) working
days of the receipt of this letter of the steps you have taken to bring
your firm into compliance with the law. Your response should include an
explanation of each step being taken to correct the violations and
prevent their recurrence. We do note that you initiated some corrective
actions during the inspection, including a feed recall and printing new
labels. If corrective action cannot be completed within 15 working days,
state the reason for the delay and date by which the corrections will be
completed. Include copies of any available documentation demonstrating
that corrections have been made. Your response should be directed to
Philip S. Campbell, Compliance Officer, at the address noted in the
letterhead.

Sincerely,

/s/

Mary Woleske, Director
Atlanta District

http://www.fda.gov/foi/warning_letters/g4900d.htm


Public Health Service
Food and Drug Administration

San Francisco District
1431 Harbor Bay Parkway
Alameda, CA 94502-7070
Telephone: 510/337-6700


VIA HAND DELIVERY

Our Reference No. 1000123954

June 23, 2004

Ronald M. Foster, Manager
Randall C. Boyce, Manager
Trevor O. Foster, Manager
George P. Foster, Manager
Fresno Farming LLC
P.O. Box 457
1000 Davis Street
Livingston, California

WARNING LETTER

Dear Mssrs. Foster, Boyce, Foster, and Foster:

The U.S. Food and Drug Administration (FDA) conducted an inspection of
your medicated animal feed mill operation, Fresco Farming LLC, located
in Traver, California from April 14, 2004 through May 6, 2004, and found
significant deviations from the requirements set forth in Title 21, Code
of Federal Regulations, Section 589.2000 (21 C.F.R. 589.2000) - Animal
Proteins Prohibited in Ruminant Feed. The regulation is intended to
prevent the establishment and amplification of Bovine Spongiform
Encephalopathy (BSE). Because you failed to follow this rule, products
you manufactured and distributed are adulterated within the meaning of
Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act)
because they were prepared, packed, or held under insanitary conditions
whereby they may have been rendered injurious to health.

Our inspection found the following violations of 21 C.F.R. 589.2000:

1. Failure to provide for measures to avoid commingling or
cross-contamination of products that contain or may contain protein
derived from mammalian tissues into animal protein or feeds that may be
used for ruminants to comply with 21 C.F.R. 589.2000(e)(1)(iii).

* Your firm uses a vacuum system to clean up spilled product in the
tunnel area. This tunnel area houses the two receiving conveyor
systems and the elevators for the two conveyor systems. When
product, including ruminant meat and bone meal, is spilled onto
the floor of this area, the spilled product is vacuumed up by the
vacuum system and, via a discharge hose, was placed into a
conveyor system that your firm had designated as free of ruminant
meat and bone meal. Your firm admitted that it was unaware of the
vacuum system discharging into the conveyor systems designated as
free of ruminant meat and bone meal and that this had been in
place since April 2003. Your firm remedied this problem during
FDAs April/May 2004 inspection by removing the discharge hose
connection to the conveyer system that your firm had designated as
free of ruminant meat and bone meal .
* Your firm uses a dust collection system that pulls dust from
systems that receive both ruminant meat and bone meal and feed
ingredients intended for ruminants. This dust system then
discharged collected product back into the two conveyor systems
via a cross connection, thereby making it likely that ruminant
meat and bone meal became commingled with ruminant feed
ingredients. Your firm admitted that it was unaware of the cross
connection and that it had been in place since April 2003. Your
firm removed the cross connection during FDAs April/May 2004
inspection.

2. Failure to maintain written procedures specifying the clean-out
procedure or other means, and specifying the procedures for separating
products that contain or may contain protein derived from mammalian
tissue from all other protein products from the time of receipt until
the time of shipment, to comply with 21 C.F.R. 589.2000(e)(1)(iv). This
observation was also noted during FDAs July/August 2003 inspection of
your firm.

* There are no written procedures for separating products that
contain prohibited material from ingredients used in ruminant
feeds from the time of receipt until the time of shipment.
* The written procedure for cleaning out or flushing equipment after
mixing feeds containing prohibited material was not adequate to
prevent contamination of ruminant feed with prohibited material.

3. Failure to maintain records sufficient to track materials that
contain protein derived from mammalian tissues throughout their receipt,
processing, and distribution to comply with 21 C.F.R. 589.2000(e)(1)(i).
This observation was also noted during FDAs July/August 2003 inspection
of your firm.

* Specifically, your firm has failed to develop and implement
complete written procedures to separate ruminant meat and bone
meal from feed ingredients intended for ruminants from the time of
receipt until the time of distribution. The written procedures
that do exist fail to address the use of equipment common to
ruminant meat and bone meal and ruminant feed ingredients.

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

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

Please send your reply to the U.S. Food and Drug Administration,
Attention: Ms. Harumi Kishida, Compliance Officer, 1431 Harbor Bay
Parkway, Alameda, California 94502-7070. If you have questions regarding
this letter, please contact Ms. Kishida at (510) 337-6824.

Sincerely,

/s/

CD Moss, Acting DD for
Barbara J. Cassens
District Director
San Francisco District

cc:
VIA CERTIFIED MAIL
RETURN RECEIPT REQUESTED
C. Michael Blasco, Feed Mill Manager
Fresno Farming LLC
P.O. Box 430
Traver, California 93673

http://www.fda.gov/foi/warning_letters/g4849d.htm


Public Health Service
Food and Drug Administration

Chicago District
550 West Jackson Blvd., 15th Floor
Chicago, Illinois 60661
Telephone: 312-353-5863


July 12, 2004

WARNING LETTER
CHI-16-04

CERTIFIED MAIL
RETURN RECEIPT REQUESTED

Mr. Donald E. Hamilton, President/Owner
Illini Feeds, Inc.
P.O. Box 86, 1145 State Hwy. 94
Aledo, Illinois 61231

Dear Mr. Hamilton:

On February 19 and 20, 2004, the Food and Drug Administration (FDA)
conducted an inspection of your animal feed handling facility located at
1145 State Highway 94, Aledo, Illinois. The inspection found significant
deviations from the requirements set forth in Title 21, Code of Federal
Regulations, Part 589.2000 (21 CFR 589.2000) - Animal Proteins
Prohibited in Ruminant Feed. This regulation is intended to prevent the
establishment and amplification of Bovine Spongiform Encephalopathy
(BSE). The deviations cause the swine feed manufactured by your facility
to be misbranded within the meaning of Section 403(a)(1) of the Federal
Food, Drug, and Cosmetic Act (the Act).

Our investigation found that salvaged pet food containing prohibited
material was added as an ingredient to the swine products manufactured
at your facility. During the inspection, our investigator found that you
failed to label your non-ruminant products with the required caution
statement - Do not feed to cattle or other ruminants. [21 CFR
589.2000(d)(1)]

The above is not intended to be an all-inclusive list of violations. As
a manufacturer of materials intended for use in animal feed, you are
responsible for assuring that your overall operation and the products
you manufacture and distribute are in compliance with the law.

You should take prompt action to correct this violation, and you should
establish a system whereby such violations do not recur. Failure to
promptly correct this violation may result in regulatory action without
further notice, such as seizure and/or injunction.

During the inspection, you told the investigator that you would put the
required cautionary statement on your products that contain prohibited
material, and maintain tracking documents for all incoming ingredients,
including animal proteins prohibited in ruminant feed. Please notify
this office in writing within 15 working days of receiving this letter
of any further steps you have taken to assure that your firm is in
compliance with the law. Your response should also include an
explanation of each step taken to correct the violations, and prevent
their recurrence. Please include copies of any available documentation
such as written procedures, corrected labeling, etc., demonstrating that
corrections have been made. If corrections cannot be completed within 15
working days, state the reason for the delay and the date by which the
corrections will be completed.

Your reply should be directed to Paul A. Boehmer, Compliance Officer, at
the above address.

Sincerely,

/s/

Scott J. MacIntire
District Director

http://www.fda.gov/foi/warning_letters/g4840d.htm


Public Health Service
Food and Drug Administration

Chicago District
550 West Jackson Blvd., 15th Floor
Chicago, Illinois 60661
Telephone: 312-353-5863


June 15, 2004

WARNING LETTER

CERTIFIED MAIL
RETURN RECEIPT REQUESTED

Mr. David W. Bernauer
CEO and Chairman of the Board
Walgreen co.
200 Wilmot Rd.
Deerfield, IL 60015

Dear Mr. Bernauer:

Inspection of your firms warehouse at 5100 Lake Terrace N.E., Mt.
Vernon, Illinois, by the Illinois Department of Public Health and the
U.S. Food and Drug Administration (FDA) on February 25, 26, and 27, and
March 2, 2004, documented numerous insanitary conditions which caused
the food and drug products stored there to become adulterated.

Our inspection showed that the food and drug products stored and held at
your facility violated the Federal Food, Drug, and Cosmetic Act (the
Act), rendering them adulterated. These adulterated fwd and drug
products: a) consisted in whole or in part of filthy substances,
including rodent fecal pellets, rodent hair, and insects, in violation
of Section 402(a)(3) of the Act [21 U.S.C. 342(a)(3)]; and/or b) had
been held under insanitary conditions whereby they have become
contaminated with rodent filth, in violation of Sections 402(a)(4) and
501(a)(2)(a) of the Act [21 U.S.C. 342(a)(4), 351(a)(2)(a)].

Evidence of rodent activity documented throughout the old and new
warehouse included dead mice in traps, excreta pellets, and gnawed paper
material observed in, on, and near food and drugs stored in the
warehouse. Rodents gnaw holes were observed into several packaged food
products with rodent hairs at gnaw holes into products. Many more fecal
pellets were on food and drug packages and still more were found near
the stored foods, drugs, and cosmetics in the warehouse.

Other conditions observed during the inspection that could be
contributing factors to rodent infestation include damaged and/or poorly
fitting rail and truck dock doors, gaps around a conduit entry into the
building, and the structural condition of the concrete and expansion
gaps at floor/wall/support beam junctions in various areas of the
warehouse allowing the entry or harborage of pests. Additionally, the
investigators observed cobwebs, dead insects, dust, debris, product
spillage, and papers in the warehouse, indicating a general lack of good
sanitation practices.

Also, products that contain or may contain animal protein prohibited
ruminant feed (BSE material) failed to bear the caution statement, Do
not feed to cattle or other ruminants. Specifically, pet food products
were salvaged, repackaged, and donated to [redacted] and other similar
organizations in the area, without the proper labeling and agreement
that they would not be used for ruminants. Please refer to Title 21,
Code of Federal Regulations, Section 589.2000, concerning these
requirements.

Our laboratory confirmed the findings of rodent excreta, rodent hairs on
product gnaw holes, and rodent gnawed fibers (packaging material)
sampled from the warehouse during the inspection.

The above listed violations are not intended to be all-inclusive. It is
your responsibility to assure adherence with each requirement of the Act
and its implementing regulations. The investigators reported that you
destroyed food products that showed evidence of contamination and began
to take some steps to correct the insanitary conditions in your
facility. We request that you take prompt action to correct all violations.

Please provide this office, within 15 working days of receipt of this
letter, a detailed response stating the actions you plan to take and
have taken to correct and prevent the recurrence of these objectionable
conditions. Provide the time within which corrections will be completed,
reasons why any corrective action cannot be completed, and documentation
to show that corrections have been made. Failure to take prompt action
to correct all violations may result in regulatory action without
further notice. Such action includes seizure and/or injunction.

Your reply should be directed to Paul A. Boehmer, Compliance Officer, at
the Chicago District Office.

Sincerely,

/s/

Scott J. MacIntire
District Director

cc:
Stephen J. Lawrence,
Distribution Center Manager
Walgreen Co.
5100 Lake Terrace NE
Mount Vernon, IL 62864-9665

http://www.fda.gov/foi/warning_letters/g4853d.htm

RECALLS AND FIELD CORRECTIONS: VETERINARY - CLASS II

_______________________________

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
Corn 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


Greetings list members,

> VOLUME OF PRODUCT IN COMMERCE
> UNKNOWN.
>
> DISTRIBUTION
> UNKNOWN.

gotta love those USDA BSE/TSE triple fire walls ;-).....TSS

Docket No. 2003N-0312 Animal Feed Safety System [TSS SUBMISSION]

http://www.fda.gov/ohrms/dockets/dockets/03n0312/03N-0312_emc-000001.txt

Docket Management Docket: 02N-0273 - Substances Prohibited From Use in

Animal Food or Feed; Animal Proteins Prohibited in Ruminant Feed

Comment Number: EC -10

Accepted - Volume 2


http://www.fda.gov/ohrms/dockets/dailys/03/Jan03/012403/8004be07.html

PART 2


http://www.fda.gov/ohrms/dockets/dailys/03/Jan03/012403/8004be09.html


TSS





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