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From: TSS ()
Subject: SENATE BILL REPORT SB 5190 An act relating to adulteration of commercial feed (fine not to exceed $5,000 and up to one year in jail)
Date: March 10, 2005 at 1:36 pm PST

-------- Original Message --------
Subject: SENATE BILL REPORT SB 5190 An act relating to adulteration of commercial feed (fine not to exceed $5,000 and up to one year in jail)
Date: Thu, 10 Mar 2005 15:40:50 -0600
From: "Terry S. Singeltary Sr."
Reply-To: Bovine Spongiform Encephalopathy
To: BSE-L@KALIV.UNI-KARLSRUHE.DE


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

SENATE BILL REPORT
SB 5190
------------------------------------------------------------------------
------------------------------------------------------------------------

As Reported By Senate Committee On:
Agriculture & Rural Economic Development, February 15, 2005

Title: An act relating to adulteration of commercial feed.

Brief Description: Concerning adulterated commercial feed.

Sponsors: Senators Fraser, Schoesler, Rasmussen and Swecker.

Brief History:

Committee Activity: Agriculture & Rural Economic Development: 2/3/05,
2/15/05 [DPS].

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

SENATE COMMITTEE ON AGRICULTURE & RURAL ECONOMIC DEVELOPMENT

Majority Report: That Substitute Senate Bill No. 5190 be substituted
therefor, and the substitute bill do pass.Signed by Senators Rasmussen,
Chair; Shin, Vice Chair; Schoesler, Ranking Minority Member; Delvin,
Jacobsen and Morton.

Staff: Margaret King (786-7416)

Background: The federal Food and Drug Administration has adopted rules
as part of the prevention system for spread of bovine spongiform
encephalopathy (BSE) that prohibits the use of by-products of ruminant
animals as feed supplements for other ruminants. This is commonly
referred to as the ruminant to ruminant feed ban. The Washington State
Department of Agriculture administers the state commercial feed laws
which also includes this federal rule.

It is a misdemeanor to distribute adulterated commercial feed in the
State of Washington. The penalty under current law is a fine of up to
$50 for the first offense and up to $250 for a second offense.

Summary of Substitute Bill: Language is added to include within the
definition of adulterated commercial feed any ruminant feed that
contains any animal protein that is prohibited and listed as unsafe
pursuant to the current federal regulations that are in place under the
Federal Food, Drug, and Cosmetic Act. The penalty for intentionally
violating the provision is increased from a misdemeanor to a gross
misdemeanor. Gross misdemeanors are punishable by a fine not to exceed
$5,000 and up to one year in jail.

Other violations of the feed law are considered as standard misdemeanors
which are punishable by a fine of up $1,000 and up to ninety days in jail.

Substitute Bill Compared to Original Bill: The original bill was not
considered.

Appropriation: None.

Fiscal Note: Not requested.

Committee/Commission/Task Force Created: No.

Effective Date: Ninety days after adjournment of session in which bill
is passed.

Testimony For: The major firewall to protect cows from bovine spongiform
encephalopathy (mad cow disease) is to prohibit feeding cow protein to
cows. Violation of that prohibition should be changed from a misdemeanor
to a gross misdemeanor to send clear message of strong enforcement.
Concerns with original language but change in proposed substitute bill
makes it clear that bill prohibits unsafe ingredients as set forth in
the federal regulations for ruminant feed.

Testimony Against: None.

Who Testified: PRO: Senator Fraser, prime sponsor; Jack Field, WA
Cattlemen's Association; Jim Jesernig, Agri Beef; Ted Wishon, Stevens
County Farm Bureau; Ted Maxwell, WSDA.

http://www.leg.wa.gov/pub/billinfo/2005-06/Htm/Bill%20Reports/Senate/5190.SBR.htm

Will Hueston, a USDA consultant and BSE expert at the University of
Minnesota, says there's little danger to public health. Besides the
surveillance program, he says the source of contagion, feed supplements
that contained cattle parts, has been removed.

DR. WILL HUESTON: We were taking the parts of the cattle that we didn't
eat, that humans don't eat. We were cooking those to remove the fat, and
the material, the protein that was left was ground up and, in fact, used
as a protein supplement.

FRED DE SAM LAZARO: Which is now out of circulation?

DR. WILL HUESTON: -- is now out of circulation.


=========================

> Will Hueston, a USDA consultant and BSE expert at the University of
> Minnesota, says there's little danger to public health. Besides the
> surveillance program, he says the source of contagion, feed
> supplements that contained cattle parts, has been removed.


Public Health Service
Food and Drug Administration

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


January 12, 2005

Ref: 2005-DAL-WL-11

WARNING LETTER

CERTIFIED MAIL
RETURNED RECEIPT REQUESTED

Mr. William L. Brown, Owner
Brown Cattle Company
1 Feed Lot Road
P.O. Box 281
Petrolia, TX 76377

Dear Mr. Brown:

An inspection of your ruminant feeding operation located at 1 Feed Lot
Road, Petrolia, Texas, was conducted on August 24 and September 8, 2004
by an Investigator from the Food and Drug Administration (FDA). The
inspection found significant deviations from
the requirements set forth in Title 21, Code of Federal Regulations,
Part 589.2000 - Animal Proteins Prohibited in Ruminant Feed (21 CFR
589.2000). This regulation is intended to prevent the establishment and
amplification of Bovine Spongiform Encephalopathy (BSE).

Our inspection revealed that you feed prohibited material, as defined by
21 CFR 598.2000(a), to ruminants. This prohibited material consists of
human food processing waste, which is derived from corn dog
manufacturing and contains hot dogs and corn dogs. Inspected meat
products that have been cooked and offered for human food and further
heat processed for animal feed are not prohibited material. This is more
fully described in Guidance for Industry 76, which was previously
provided to your firm. The human food processing waste you are using has
not been further heat processed. The failure to further heat process
this material causes the feed to be adulterated within the meaning of
Section 402(a)(2)(C)(i) of the Federal, Food, Drug, and Cosmetic Act.

During our previous inspection on January 17, 2002, copies of the BSE
Guidance documents 69, 70 and 76 and 21 CFR 589.2000, the BSE
regulation, were provided to and discussed with you.

Failure to correct these violations may result in FDA taking regulatory
action without further notice including, but not limited to, seizure
and/or injunction.

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

Sincerely,

/s/

Michael A. Chappell

Dallas District Director

http://www.fda.gov/foi/warning_letters/g5175d.htm


Public Health Service
Food and Drug Administration

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

February 7, 2005

Ref: 2005-DAL-WL-12

WARNING LETTER

CERTIFIED MAIL
RETURNED RECEIPT REQUESTED

Mr. Dwayne Woody, Owner
W.W. Cattle Company
6391 Old Agnes Road
Poolville, TX 76487

Dear Mr. Woody:

An inspection of your feed manufacturing operation located at 6391 Old
Agnes Road, Poolville, Texas, was conducted on August 27 and September
2, 2004 by an Investigator from the Food and Drug Administration (FDA).
The inspection found significant deviations from the requirements set
forth in Title 21, Code of Federal Regulations, Part 589.2000 - Animal
Proteins Prohibited in Ruminant Feed (21 CFR 589.2000). This regulation
is intended to prevent the establishment and amplification of Bovine
Spongiform Encephalopathy (BSE). Because you failed to follow the
requirements of this regulation, the corn dogs containing cooked meat
and other ingredients used for manufacturing ruminant feed are
adulterated within the meaning of Section 402(a)(2)(C)(i) and misbranded
within the meaning of Section 403(a)(1) of the Federal, Food, Drug and
Cosmetic Act (the Act).

The use of protein derived from mammalian tissues, as defined in 21 CFR
589.2000(a)(1), as an animal feed ingredient or in animal feeds must
comply with the requirements of 21 CFR 589.2000. That regulation
provides that the use of protein derived from mammalian tissues in
ruminant feed is prohibited. The definition of protein derived from
mammalian tissues excludes inspected meat products which have been
cooked and offered for human food, such as the corn dogs you receive,
that have been further heat processed for use in animal feed. This
requirement was previously communicated to you in an April 3, 2001
letter from the Texas State Feed and Fertilizer Control Service. In the
absence of the required further heat processing, such products for use
in ruminant feeds are adulterated under Section 402(a)(2)(C)(i) of the Act.

Our inspection revealed that whole corn dogs which contain protein
derived from mammalian tissues and are sold by your firm to the
[redacted] for use in ruminant feed are not subjected to further
adulterated feed under Section 402(a)(2)(C)(i) of the Act.

In addition, because the whole corn dogs are not subjected to further
heat processing and are thus not exempt from the regulation, they must
bear the caution statement, Do not feed to cattle or other ruminants.
Our inspection revealed that they do not bear this caution statement,
which causes them to be misbranded animal feed under Section 403(a)(1)
of the Act.

Copies of the BSE Guidance documents 69, 70 and 76 were provided to Mr.
Billy J. Brooks, General Manager, and further discussed by personnel
from the Texas Feed and Fertilizer Control Service. Also, you received a
copy of the 21 CFR 589.2000, the BSE regulation which was again
explained in more specific detail. These serious violations 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 a
court injunction against further sale of protein derived from mammalian
tissues for use in ruminant feed or ruminant feed containing such
materials.

It is necessary for you to take action on this matter now. Please notify
this office in writing within fifteen (15) working days from the date
you received this letter. Your response should specifically identify the
actions you are taking to correct the violations that would involve the
continued use of corn dogs to manufacture ruminant feed and provide
specific timeframes for achieving compliance. Your reply should be sent
to Edwin Ramos, Compliance Officer, at the above stated address. If you
have any questions concerning the stated matters, you may contact Mr.
Ramos at 214-253-5218.

Sincerely,
/s/

Michael A. Chappell
Dallas District Director

http://www.fda.gov/foi/warning_letters/g5184d.htm

TSS

Public Health Service
Food and Drug Administration

New Orleans District
Southeast Region
6600 Plaza Drive, Suite 400
New Orleans, Louisiana 70127
Telephone: 504-253-4519
Facsimile: 504-253-4520


December 9, 2004

WARNING LETTER NO. 2005-NOL-07

FEDERAL EXPRESS
OVERNIGHT DELIVERY

Mr. Alan O. Bostick, President
Sunshine Mills, Inc.
500 6th Street SW
Red Bay, Alabama 35582

Dear Mr. Bostick:

On September 7 and 14, 2004, a United States Food and Drug
Administration (FDA) investigator inspected your animal feed
manufacturing facility, located at 2103 South Gloster Street, Tupelo,
Mississippi. The inspection revealed significant deviations from the
requirements set forth in Title 21, Code of Federal Regulations, Part
589.2000 (21 CFR 589.2000) - Animal Proteins Prohibited in Ruminant
Feed. The regulation is intended to prevent the establishment and
amplification of Bovine Spongiform Encephalopathy (BSE). Because you
failed to follow the requirements of this regulation, products you
manufactured and/or distributed are misbranded within the meaning of
Section 403(a)(1) of the Federal Food, Drug, and Cosmetic Act (the Act).

The inspection indicated you manufacture products containing beef meat
and bone meal. Products that contain or may contain protein derived from
mammalian tissues, as defined by 21 CFR 589.2000(a), and are intended
for use in animal feed, must be labeled with the cautionary statement
Do not feed to cattle or other ruminants. This is required by 21 CFR
589.2000(c)(1)(i). Your firm failed to label your non-ruminant products
with this required cautionary statement. Specifically, the products that
contained protein derived from mammalian tissues but lacked the required
statement included your Happy Fisherman and Premier catfish feeds.
Under 21 CFR 589.2000(g)(2), failure of these feeds to bear the required
cautionary statement causes them to be misbranded under Section
403(a)(1) of the Act.

The above is not intended to be an all-inclusive list of deviations from
regulations. As a manufacturer of materials intended for animal feed
use, you are responsible for assuring your overall operation and
products you manufacture and distribute are in compliance with the law.
A copy of FDAs Small Entity Compliance Guide is enclosed to assist you
in complying with the regulations.

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

We are aware you sent label corrections for the last shipment of each of
the mislabeled products. You also stated you plan [redacted] However,
you should notify this office in writing, within 15 working days of the
receipt of this letter, of the steps you have taken to bring your firm
into compliance with the law. Your response should include an
explanation of each step taken to correct violations and prevent their
recurrence. If corrective action cannot be completed within 15 working
days, state the reason for delay and date by which corrections will be
completed. Include copies of any available documentation demonstrating
corrections have been made.

Please send your reply to the U.S. Food and Drug Administration,
Attention: Nicole F. Hardin, Compliance Officer, at the above address.
If you have questions regarding any issue in this letter, please contact
Ms. Hardin at (504) 253-4519.

Sincerely,

/s

H. Tyler Thornburg
District Director
New Orleans District

Enclosures:
FDA Form 483
FDAs Small Entity Compliance Guide
21 CFR 589.2000

cc:
[redacted]
General Manager
Sunshine Mills, Inc.
2103 South Gloster Street
Tupelo, Mississippi 38801

http://www.fda.gov/foi/warning_letters/g5105d.htm

TSS

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 1ű2 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.

_______________________________

END OF ENFORCEMENT REPORT FOR October 20, 2004

http://www.fda.gov/TSS


Public Health Service
Food and Drug Administration

Seattle District
Pacific Region
22201 23rd Drive SE
Bothell, WA 9S9214421
Telephone: 425-486-8788
FAX: 425- 483-4996


November 18, 2004

VIA FEDEX

In reply refer to Warning Letter SEA 05-07

William B. Parrish, Chairman of the Board
Parrish & Heimbecker Limited
360 Main Street
Winnipeg, Manitoba, R3C 323 Canada

WARNING LETTER

Dear Mr. Parrish:

An inspection of your feed mill operation, Conway Feed, Inc., located at
18700 Main Street, Conway, Washington, conducted by a Washington State
Department of Agriculture Investigator, on June 17, 18 and 22, 2004,
under contract with the Food and Drug Administration (FDA), found
significant deviations from the requirements set forth in Title 21, Code
of Fedederal Regulations, Part 589.2000 (21 CFR 589.2000) Animal
Proteins Prohibited in Ruminant Feed. The regulation is intended to
prevent the establishment and amplification of Bovine Spongiform
Encephalopathy (BSE). Such deviations cause products being manufactured
and/or distributed by this facility to be adulterated within the meaning
of Section 402(a)(4) and misbranded within the meaning of Section 403(a)
and 403(f) of the Federal Food, Drug and Cosmetic Act (the Act).

Our investigation found that because you failed to adequately inspect
the label of a raw material, au ingredient with the cautionary
statement Do Not Feed to Cattle or Other Ruminants was used in the
manufacture of your finished product, Game Bird Crum/Pellet. Your final
product, however, did not have the cautionary statement. Because this
fish meal may have contained prohibited animal proteins, any product
produced with it must have the cautionary label. See 21 CFR 589.2000(d)(1).

The investigation also revealed that the label of your Game Bird
Crum/Pellet feed did not list fish meal as an ingredient. According to
the information we collected during the inspection fish meal is
routinely added to this ration. All ingredients are required to be
listed on the label in descending order of predominance by weight. See
21 CFR 501.4(a).

The above is not intended to be an all-inclusive list of deviations from
the regulations. As a manufacturer of materials intended for animal feed
use, you are responsible for assuring that your overall operation and
the products you manufacture and distribute are in compliance with the
law. We have enclosed a copy of the FDAs Small Entity Compliance Guide
to assist you with complying with the regulation.

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

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

Please send your reply to the Food and Drug Administration, Attention:
Bruce Williamson, Compliance Officer, 22201 23rd Drive SE, Bothell,
Washington 98021. If you have questions regarding any issue in this
letter, please contact Mr. Bruce Williamson at (425) 483-4976.

If you have questions regarding any issue in this letter, please contact
Mr. Bruce Williamson at (425) 483-4976.

Sincerely,

/S/

Charles M. Breen
District Director

cc: Scott C. McKnight, General Manager
Conway Feed Inc.
18700 Main Street
Conway, WA 98238-0576

Enclosure: Form FDA 483
Small Entity Compliance Guide

http://www.fda.gov/foi/warning_letters/g5086d.htm


USA BSE/TSE TRIPLE FIREWALLS SEEPING IN 2004...TSS


Public Health Service
Food and Drug Administration

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


VIA HAND DELIVERY

Our Reference No. 1000123954

June 23, 2004

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

WARNING LETTER

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

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

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

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

* Your firm uses a vacuum system to clean up spilled product in the
tunnel area. This tunnel area houses the two receiving conveyor
systems and the elevators for the two conveyor systems. When
product, including ruminant meat and bone meal, is spilled onto
the floor of this area, the spilled product is vacuumed up by the
vacuum system and, via a discharge hose, was placed into a
conveyor system that your firm had designated as free of ruminant
meat and bone meal. Your firm admitted that it was unaware of the
vacuum system discharging into the conveyor systems designated as
free of ruminant meat and bone meal and that this had been in
place since April 2003. Your firm remedied this problem during
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


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
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.

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

==============================================

PRODUCT
Calf Primer II-R (Monensin) sold in bulk. Recall # V-113-4.
CODE
93125 (1-7-04).
RECALLING FIRM/MANUFACTURER
Tennessee Farmers Cooperative, La Vergne, TN, by telephone on January 9,
2004. Firm initiated recall is complete.
REASON
Calf feed, which had a medicated swine feed inadvertently mixed into it,
was distributed.
VOLUME OF PRODUCT IN COMMERCE
28,040 pounds.
DISTRIBUTION
TN.

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

TSS

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

######### https://listserv.kaliv.uni-karlsruhe.de/warc/bse-l.html ##########






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