Greetings and happy turkey day to all you gobblers,
re-the big bird and TSEs i.e. mad bird disease ;
Un document de 1991 indiqué dans la liste BSE-L par Terry S. Singeltary
A CONTRIBUTION TO THE NEUROPATHOLOGY OF THE RED-NECKED OSTRICH (STRUTHIO CAMELUS) - SPONGIFORM ENCEPHALOPATHY
http://www.bseinquiry.gov.uk/files/sc/Seac10/tab06.pdf
>>>Cargill Inc, the second-largest U.S. feed maker with annual production of about 8 million tons, also said it had no plans to stop using MBM in feeds for non-ruminant species.<<<
>>>So , Have they Stopped?<<<
your kidding right?
we are still feeding cows to cows in 2005 for Pete's sake, and have been since the beginning of the infamous partial and voluntary r-t-r ban was issued 8-4-97. ...
Public Health Service
Food and Drug Administration
Minneapolis District Office
Central Region
212 Third Avenue South
Minneapolis, MN 55401
Telephone: (612) 758-7119
FAX: (612) 334-4142
June 9, 2005
WARNING LETTER
CERTIFIED MAIL
RETURN RECEIPT REQUESTED
Refer to MIN 05-15
Michael J. Langenhorst
President
Anamax Corporation
P.O. Box 10067
Green Bay, WI 54307
Dear Mr. Langenhorst:
Our inspection of your rendering plant located at 505 Hardman Avenue South, South St. Paul, Minnesota, from January 12-20, 2005, 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). Because you failed to follow the requirements of this regulation, products being manufactured and distributed by your facility are adulterated within the meaning of Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. 342(a)(4)], and misbranded within the meaning of Section 403(a)(1) of the Act [21 U.S.C. 343(a)(1)].
Our investigation found that you failed to provide for measures to prevent commingling or cross-contamination and to maintain sufficient written procedures [21 CFR 589.2000(e)] in that:
1. You failed to use clean-out procedures or other means adequate to prevent carryover of protein derived from mammalian tissues into feeds that may be used for ruminants.
2. 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 that may be used for ruminants.
Our investigation also found that you failed to label products that may contain protein derived from mammalian tissues with the statement, "Do not feed to cattle or other ruminants." For example, your Feather Meal and Stabilized Poultry By-Product Meal lack this statement, even though the absence of sufficient measures to avoid commingling or cross-contamination may result in these products containing protein derived from mammalian tissues. Because your products do not bear this caution statement, they are misbranded under Section 403(a)(1) of the Act [21 U.S.C. 343(a)(1)).
The above is not intended as an all-inclusive list of violations. As a manufacturer of materials intended for animal feed use, you are responsible for ensuring that your overall operation and the products you manufacture and distribute are in compliance with the law.
You should acknowledge this letter within 15 working days of receiving and include any additional corrective actions concerning your facility. We have received your letter dated January 31, 2005, which replies to the Form FDA-483 issued on January 20, 2005, and your letter dated February 25, 2005, that states all corrections have been implemented. The corrections you have reported appear to be adequate but will be evaluated further during our follow-up inspection.
Your response should be directed to Compliance Officer Jane E. Nelson at the address on the letterhead. If you have any questions regarding this letter, you may phone Ms. Nelson at (612) 758-7119.
Sincerely,
/S/
W. Charles Becoat
Director
Minneapolis District
http://www.fda.gov/foi/warning_letters/g5373d.htm
Public Health Service
Food and Drug Administration
San Francisco District
1431 Harbor Bay Parkway
Alameda. CA 94502-7070
Telephone : 510-337-6700
VIA FEDERAL EXPRESS
Our Reference: 3004508183
April 6, 2005
Priscilla D. Shaw
Owner
A&A Services
92-353 Laaloa St.
Kapolei, HI 96707
WARNING LETTER
Dear Ms. Shaw:
On January 10 and 11, 2005, we inspected your animal feed distribution operation located at 92-353 Laaloa St., Kapolei, HI 96707, 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).
Products that contain or may contain protein derived from mammalian tissues and that are intended for use in animal feed (prohibited material) must be labeled with the cautionary statement, "Do not feed to cattle or other ruminants" [21 C.F.R. 589.2000(d)(1) and (cx1)(i)]. Our inspection found that you are not labeling the products you are distributing to swine farms, which contain food waste from restaurants and hospital cafeterias, with this caution statement. As a result, these products are misbranded within the meaning of Section 403(a)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 343(a)(1)).
Our inspection also found that you use the same containers to hold both prohibited materials [redacted] waste to be used for feed for non-ruminants and non-prohibited materials [redacted] waste to be used for feed for ruminants). However, you failed to provide written procedures specifying clean-out procedures or other measures to avoid cross-contamination of the feed products to be used for ruminants [21 C.F.R. 589.2000(e)(1)(iv)]. You also failed to make copies of distribution records available for FDA inspection and copying (21 C.F.R. 589.2000(c)(1)(ii)].
At the conclusion of the inspection, these and other observations were listed on Form FDA 483, Inspectional Observations, which was issued to and discussed with you at the close of the inspection . A copy of this form is enclosed for your ready reference.
The above is not meant to be an a11-inclusive list of deficiencies at your facility. It is your responsibility to ensure that all of your products 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 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. If corrective actions cannot be completed in fifteen (15) days, state the mason for the delay and the date by which the corrections will be completed. Include copies of any available documentation demonstrating that corrections have been made.
Your reply should be directed to Paul A. Peterson, Compliance Officer, Food and Drug Administration, 1431 Harbor Bay Parkway, Alameda, CA 94502. If you have any questions regarding any issue in this letter, you may contact Mr. Peterson at (510) 337-6856.
Sincerely,
/S/
Barbara J. Cas
District Director
San Francisco District
http://www.fda.gov/foi/warning_letters/g5272d.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
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
Anamax Corporation
6/09/05
Minneapolis District Office Animal Proteins Prohibited in Ruminant Feed [PDF]
HTML:
No
Menu Foods, Inc.
5/19/04
New Jersey District Office Animal Proteins Prohibited in Ruminant Feed [PDF]
[HTML]
No
Millstone Agri Distributors
5/22/03
Nashville District Office Animal Proteins Prohibited in Ruminant Feed [PDF]
[HTML]
No
Specialty Brands, Inc.
6/15/04
Dallas District Office Animal Proteins Prohibited in Ruminant Feed [PDF]
[HTML]
No
Zephyr Feed Company
5/28/03
Florida District Office Animal Proteins Prohibited in Ruminant Feed [PDF]
[HTML]
No
All American Feed & Tractor
4/01/02
Seattle District Office Animal Proteins Prohibited in Ruminant Feed/Adulterated [PDF]
[HTML]
No
Brown Cattle Company
1/12/05
Dallas District Office Animal Proteins Prohibited in Ruminant Feed/Adulterated [PDF]
[HTML]
No
Chapman Ranch
6/10/04
Dallas District Office Animal Proteins Prohibited in Ruminant Feed/Adulterated [PDF]
[HTML]
No
Fresno Farming LLC
6/23/04
San Francisco District Office Animal Proteins Prohibited in Ruminant Feed/Adulterated [PDF]
[HTML]
No
Sunnymead Ranch, Inc.
11/07/02
Dallas District Office Animal Proteins Prohibited in Ruminant Feed/Adulterated [PDF]
[HTML]
No
Van Dyke Grain Elevators Inc
4/17/02
Seattle District Office Animal Proteins Prohibited in Ruminant Feed/Adulterated [PDF]
[HTML]
No
W.W. Cattle Company
2/07/05
Dallas District Office Animal Proteins Prohibited in Ruminant Feed/Adulterated [PDF]
[HTML]
No
Halter Feed & Grain, Inc.
4/08/04
Cincinnati District Office Animal Proteins Prohibited in Ruminant Feed/Adulterated/Misbranded [PDF]
[HTML]
No
Horn's Feed Mill, Inc.
9/26/03
Chicago District Office Animal Proteins Prohibited in Ruminant Feed/Adulterated/Misbranded [PDF]
[HTML]
No
Parrish & Heimbecker Limited
11/18/04
Seattle District Office Animal Proteins Prohibited in Ruminant Feed/Adulterated/Misbranded [PDF]
[HTML]
No
A&A Services
4/06/05
San Francisco District Office Animal Proteins Prohibited in Ruminant Feed/Misbranded [PDF]
[HTML]
No
B & G Seed Company
6/10/04
Atlanta District Office Animal Proteins Prohibited in Ruminant Feed/Misbranded [PDF]
[HTML]
No
Bakery Trading Company
7/29/02
Kansas City District Office Animal Proteins Prohibited in Ruminant Feed/Misbranded [PDF]
[HTML]
No
Bardstown Mill, Inc.
4/08/04
Cincinnati District Office Animal Proteins Prohibited in Ruminant Feed/Misbranded [PDF]
[HTML]
No
Barr Animal Foods
5/06/03
Minneapolis District Office Animal Proteins Prohibited in Ruminant Feed/Misbranded [PDF]
[HTML]
No
Darling International, Inc.
5/07/02
Seattle District Office Animal Proteins Prohibited in Ruminant Feed/Misbranded [PDF]
[HTML]
No
Illini Feeds, Inc.
7/12/04
Chicago District Office Animal Proteins Prohibited in Ruminant Feed/Misbranded [PDF]
[HTML]
No
Lincoln Land Livestock Co., Inc.
8/25/03
Chicago District Office Animal Proteins Prohibited in Ruminant Feed/Misbranded [PDF]
[HTML]
No
Premium Nutritional Products, Inc.
4/15/04
Kansas City District Office Animal Proteins Prohibited in Ruminant Feed/Misbranded [PDF]
[HTML]
No
Sunshine Mills, Inc.
12/09/04
New Orleans District Office Animal Proteins Prohibited in Ruminant Feed/Misbranded [PDF]
[HTML]
No
http://www.accessdata.fda.gov/scripts/wlcfm/subject.cfm?FL=
Central Ohio Farmers Cooperative, Inc.
5/24/01
Cincinnati District Office Animal Protein Prohibited in Ruminant Feed [PDF]
No
Material Resources, LLC
5/04/01
Chicago District Office Animal Protein Prohibited in Ruminant Feed [PDF]
No
Western Reserve Farm Cooperative
3/21/01
Cincinnati District Office Animal Protein Prohibited in Ruminant Feed [PDF]
No
River Valley Co-Op
3/22/01
Cincinnati District Office Animal Proteins Prohibeted in Ruminant Feed [PDF]
No
Adrian Elevator, Inc.
5/03/01
Minneapolis District Office Animal Proteins Prohibited in Ruminant Feed [PDF]
No
Alaska Garden and Pet Supply, Inc.
4/27/01
Seattle District Office Animal Proteins Prohibited in Ruminant Feed [PDF]
No
Carrollton Farmers Exchange
7/12/01
Cincinnati District Office Animal Proteins Prohibited in Ruminant Feed [PDF]
[HTML]
No
Centerburg Mill and General Store, Inc
3/23/01
Cincinnati District Office Animal Proteins Prohibited in Ruminant Feed [PDF]
No
Centerburg Mill and General Store, Inc.
5/23/01
Cincinnati District Office Animal Proteins Prohibited in Ruminant Feed [PDF]
No
Countryline Co-Op, Inc.
5/14/01
Cincinnati District Office Animal Proteins Prohibited in Ruminant Feed [PDF]
No
Dorset Milling
4/16/01
Cincinnati District Office Animal Proteins Prohibited in Ruminant Feed [PDF]
No
Earl B. Olson Feed Mill
4/23/01
Minneapolis District Office Animal Proteins Prohibited in Ruminant Feed [PDF]
No
Faler Feed Store, Inc.
3/21/01
Cincinnati District Office Animal Proteins Prohibited in Ruminant Feed [PDF]
No
Farmers Mill & Elevator Company
3/30/01
Atlanta District Office Animal Proteins Prohibited in Ruminant Feed [PDF]
No
Greeley Elevator Company
4/04/01
Denver District Office Animal Proteins Prohibited in Ruminant Feed [PDF]
No
Himmelspach, William W.
8/08/01
Seattle District Office Animal Proteins Prohibited in Ruminant Feed [PDF]
[HTML]
No
Integral Fish Foods, Inc.
6/12/01
Denver District Office Animal Proteins Prohibited in Ruminant Feed [PDF]
No
Jefferson Milling Company
4/16/01
Cincinnati District Office Animal Proteins Prohibited in Ruminant Feed [PDF]
No
Lime Creek Ag Services, Inc.
4/25/01
Minneapolis District Office Animal Proteins Prohibited in Ruminant Feed [PDF]
No
Material Resources LLC
5/04/01
Chicago District Office Animal Proteins Prohibited in Ruminant Feed [PDF]
No
Medina Landmark, Inc.
3/23/01
Cincinnati District Office Animal Proteins Prohibited in Ruminant Feed [PDF]
No
Perry Coal and Feed Company
4/16/01
Cincinnati District Office Animal Proteins Prohibited in Ruminant Feed [PDF]
No
Rietdyk's Milling Company
3/05/01
Seattle District Office Animal Proteins Prohibited in Ruminant Feed [PDF]
No
River Valley Co-Op
5/22/01
Cincinnati District Office Animal Proteins Prohibited in Ruminant Feed [PDF]
No
Round Lake Farmers Coop.
5/30/01
Minneapolis District Office Animal Proteins Prohibited in Ruminant Feed [PDF]
No
Rudy, Inc.
5/22/01
Cincinnati District Office Animal Proteins Prohibited in Ruminant Feed [PDF]
No
Rudy, Inc.
3/22/01
Cincinnati District Office Animal Proteins Prohibited in Ruminant Feed [PDF]
No
Sandy Lake Mills
4/09/01
Philadelphia District Office Animal Proteins Prohibited in Ruminant Feed [PDF]
No
Shields Feed and Supply Company
3/07/01
New Orleans District Office Animal Proteins Prohibited in Ruminant Feed [PDF]
No
Stewart's Farm Supply
3/21/01
Cincinnati District Office Animal Proteins Prohibited in Ruminant Feed [PDF]
No
Superior Feeds
6/06/01
Seattle District Office Animal Proteins Prohibited in Ruminant Feed [PDF]
No
The Scoular Company
5/30/01
Minneapolis District Office Animal Proteins Prohibited in Ruminant Feed [PDF]
No
University of Minnesota
5/10/01
Minneapolis District Office Animal Proteins Prohibited in Ruminant Feed [PDF]
No
Valley Feed Mill, Inc.
5/22/01
Cincinnati District Office Animal Proteins Prohibited in Ruminant Feed [PDF]
No
Wallowa County Grain Growers, Inc.
5/17/01
Seattle District Office Animal Proteins Prohibited in Ruminant Feed [PDF]
No
Wallowa County Grain Growers, Inc.
5/17/01
Seattle District Office Animal Proteins Prohibited in Ruminant Feed [PDF]
No
Wilcox Farms, Inc.
9/14/01
Seattle District Office Animal Proteins Prohibited in Ruminant Feed [PDF]
[HTML]
No
Yachere Feed, Inc.
4/09/01
Philadelphia District Office Animal Proteins Prohibited in Ruminant Feed [PDF]
No
Z & W Mill, Inc.
3/27/01
Denver District Office Animal Proteins Prohibited in Ruminant Feed [PDF]
No
Agri-Mark Farmers Co-op, Inc.
8/16/01
Cincinnati District Office Animal Proteins Prohibited in Ruminant Feed/Adulterated [PDF]
[HTML]
No
Copley Feed & Supply
8/17/01
Cincinnati District Office Animal Proteins Prohibited in Ruminant Feed/Adulterated [PDF]
[HTML]
No
Dixon Feeds, Inc.
10/24/01
Seattle District Office Animal Proteins Prohibited in Ruminant Feed/Adulterated [PDF]
[HTML]
No
Farnam Companies, Inc.
7/20/01
Kansas City District Office Animal Proteins Prohibited in Ruminant Feed/Adulterated [PDF]
[HTML]
No
Finlayson Ag Center
11/08/01
Minneapolis District Office Animal Proteins Prohibited in Ruminant Feed/Adulterated [PDF]
[HTML]
No
The Hyland Co., Inc.
8/21/01
Cincinnati District Office Animal Proteins Prohibited in Ruminant Feed/Adulterated [PDF]
[HTML]
No
Buckeye Feed Mills, Inc.
9/20/01
Cincinnati District Office Animal Proteins Prohibited in Ruminant Feed/Adulterated/Misbranded [PDF]
[HTML]
No
The Feed Bucket
12/11/01
Atlanta District Office Animal Proteins Prohibited in Ruminant Feed/Adulterated/Misbranded [PDF]
[HTML]
No
Minister Farmers Cooperative Exchange, Inc.
4/10/01
Cincinnati District Office Animal Proteins Prohibited in Ruminant Feed/Feed Mill [PDF]
No
Champaign Landmark, Inc.
3/05/01
Cincinnati District Office Animal Proteins Prohibited in Ruminant Feed/Misbranded [PDF]
No
F.W. Renner & Sons, Inc.
8/27/01
Cincinnati District Office Animal Proteins Prohibited in Ruminant Feed/Misbranded [PDF]
[HTML]
No
Tyson Foods
2/12/02
Seattle District Office Animal Proteins Prohibited in Ruminant Feed/Misbranded [PDF]
[HTML]
No
http://www.accessdata.fda.gov/scripts/wlcfm/subject_archive.cfm?FL=A
and these are just the tip of the iceburg;
Mad Cow Disease: An Evaluation of a Small Feed Testing Program FDA
Implemented in 2003 With Recommendations for Making the Program a Better
Oversight Tool. GAO-06-157R, October 11
http://www.gao.gov/cgi-bin/getrpt?GAO-06-157R
TSS
----- Original Message -----
From: "Terry S. Singeltary Sr." <[email protected]>
To: <[email protected]>
Sent: Friday, October 28, 2005 9:36 AM
Subject: Hydrolyzed Feather Meal, 50 lb. bags, Recall # V-109-5 "Do not feed
to cattle or other ruminants" USA
##################### Bovine Spongiform Encephalopathy
#####################
From: TSS ()
Subject: Hydrolyzed Feather Meal, 50 lb. bags, Recall # V-109-5 "Do not feed
to cattle or other ruminants" USA
Date: October 27, 2005 at 7:33 pm PST
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
RECALLS AND FIELD CORRECTIONS: VETERINARY MEDICINE -- CLASS II
______________________________
PRODUCT
Triple Play Blocks with Rumensin, medicated feed blocks for beef animals,
sheep and goats, Recall # V-106-5
CODE
No product labeling or lot coding
RECALLING FIRM/MANUFACTURER
A-C Feed Ltd, Winters, TX, by telephone and by letter beginning June 2,
2005. Firm initiated recall is complete.
REASON
Distribution of a medicated free choice feed block for which there is no New
Animal Drug Application on file.
VOLUME OF PRODUCT IN COMMERCE
70.41 tons of Triple Play Blocks and 704.1 pounds of Rumensin 80
DISTRIBUTION
TX
______________________________
PRODUCT
a) Procaine Penicillin - 10, Type B Medicated Feed,
containing penicillin (from 10 g/lb. procaine
penicillin), 6.0 g/lb., packaged in 50-lb. bags.
Recall # V-107-5;
b) Deccox 10X, Type B Medicated Feed, containing
decoquinate, 2,271 mg/lb., packaged in 10-lb.
and 50-lb. bags. Recall # V-108-5
CODE
a) All product that is not labeled with the warning;
b) All product that does not include sheep (as well as
cows and goats) producing milk for food in the
warning statement
RECALLING FIRM/MANUFACTURER
International Nutrition, Inc., Omaha, NB, by telephone on August 3, 2005 and
by fax on August 4, 2005. Firm initiated recall is ongoing.
REASON
a) Labels lacked required warning to not feed to
chickens or turkeys producing eggs for human consumption;
b) Labels lacked required warning to not feed to sheep
producing milk for food. Cows and goats were properly
listed on the label.
VOLUME OF PRODUCT IN COMMERCE
111/50-lb. bags Procaine Penicillin -- 10;
19887/50-lb. bags and 3,710/10-lb.s Deccox 10X
DISTRIBUTION
KS, NE, MN, IA, CO, MO, and AZ
END OF ENFORCEMENT REPORT FOR SEPTEMBER 14, 2005
###
http://www.fda.gov/bbs/topics/enforce/2005/ENF00917.html
Greetings,
i am still concerned that the FDA et al seems to have stopped posting
updates on ruminant feed ban violations??? here are the last ones posted;
BSE -- CVM Updates
June 2005 Update on Feed Enforcement Activities to Limit the Spread of
BSE (June 20, 2005)
March 2005 Update on Feed Enforcement Activities to Limit the Spread
of BSE (March 17, 2005)
November 2004 Update on Ruminant Feed (BSE) Enforcement Activities
(November 23, 2004)
FDA Evaluates Test Kits to Detect Animal Proteins in Animal Feed
(November 4, 2004)
July 2004 Update on Ruminant Feed (BSE) Enforcement Activities (July
29, 2004)
FDA and USDA Request Comments and Scientific Information on Possible
New BSE Safeguards (July 9, 2004)
April 2004 Update on Ruminant Feed (BSE) Enforcement Activities (April
22, 2004)
Update on Ruminant Feed (BSE) Enforcement Activities (February 6,
2004)
Guidance for Investigators on Ruminant Feed (BSE) Inspections
Available (November 10, 2003)
Information about Ruminant Feed (BSE) Inspections Available (October
10, 2003)
Update On Ruminant Feed (BSE) Enforcement Activities (September 30,
2003)
NEW VERSION OF BSE INSPECTION CHECKLIST RELEASED (April 22, 2002)
RUMINANT FEED (BSE) ENFORCEMENT ACTIVITIES (April 15, 2002)
RUMINANT FEED (BSE) ENFORCEMENT ACTIVITIES (October 30, 2001)
FDA HOLDING PUBLIC HEARING ON RUMINANT FEED (BSE) RULES (October 10,
2001 )
BSE INSPECTION CHECKLIST AVAILABLE ON THE CVM INTERNET HOME PAGE
(September 25, 2001)
RUMINANT FEED (BSE) ENFORCEMENT ACTIVITIES (July 7, 2001 )
CVM PROVIDES INFORMATION ABOUT RUMINANT FEED (BSE) INSPECTIONS (April
19, 2001 )
RUMINANT FEED (BSE) ENFORCEMENT ACTIVITIES (March 23, 2001 )
UPDATE ON RUMINANT FEED (BSE) ENFORCEMENT ACTIVITIES (January 10,
2001 )
BSE FEED REGULATION TEAM TO RECEIVE VICE PRESIDENTIAL AWARD (May 13,
1999 )
FDA GUIDANCE ON BSE FEED REGULATION AVAILABLE (July 14, 1998 )
SATELLITE TELECONFERENCE ON FEED RULES ANNOUNCED (May 15, 1998 )
FDA GUIDANCE ON RUMINANT FEED RULES AVAILABLE (March 26, 1998)
INFORMATION FOR DAIRY AND BEEF PRODUCERS -- PROTEIN FEED RULES
(January 22, 1998)
DEADLINE FOR RUMINANT FEED RULE (October 9, 1997)
REQUEST FOR COMMENT ON RUMINANT FEED DRAFT RULE -- MAMMALIAN PROTEINS
PROHIBITED IN RUMINANT FEED (April 15, 1997)
FDA PROPOSES PRECAUTIONARY BAN AGAINST RUMINANT-TO-RUMINANT FEEDING
(January 2, 1997)
BSE "Fact Sheet"
Web Page Updated by mdt - June 21, 2005, 9:20 AM ET
http://www.fda.gov/cvm/bse_updates.htm
From: TSS ()
Subject: 15,323 TONS OF POTENTIAL TAINTED TSE RUMINANT PROTEIN WITHOUT MAD COW FEED WARNING IN CIRCULATION 4 STATES
Date: November 10, 2005 at 2:05 pm PST
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
From: TSS ()
Subject: Mad Cow Disease: An Evaluation of a Small Feed Testing Program FDA Implemented in 2003 GAO-06-157R, October 11
Date: November 9, 2005 at 12:22 pm PST
GAO
GAO-06-157R FDA Feed Testing Program
October 11, 2005
The Honorable Saxby Chambliss
Chairman
The Honorable Tom Harkin
Ranking Democratic Member
Committee on Agriculture, Nutrition, and Forestry
United States Senate
The Honorable Thad Cochran
United States Senate
The Honorable Richard J. Durbin
United States Senate
Subject: Mad Cow Disease: An Evaluation of a Small Feed Testing Program FDA
Implemented in 2003 With Recommendations for Making the Program a Better
Oversight Tool
In 1997, the Food and Drug Administration (FDA) banned the use of most proteins
derived from mammals (referred to as prohibited material) in feed intended for cattle
and other ruminants.1 The feed-ban rule is one of the primary actions taken by the
federal government to protect U.S. cattle from bovine spongiform encephalopathy
(BSE),2 commonly known as mad cow disease, which is believed to be spread through
feed that contains malformed protein found in certain tissue—particularly brain and
central nervous system tissue—of BSE-infected animals.3 Earlier this year, mad cow
disease was found for the first time in a 12-year old animal born and raised in the United
States.
In January 2002, we reported on the effectiveness of federal actions to prevent the
introduction and spread of BSE in the United States and identified a number of areas
where improvements were needed to strengthen FDA’s oversight of firms in the feed
1Ruminants are animals with four-chambered stomachs, including, but not limited to, cattle, buffalo, sheep,
goats, deer, elk, and antelope. For the purpose of this report, "cattle" refers to cattle and all other
ruminant animals and "cattle feed" refers to feed for cattle and other ruminant animals.
2
21 C.F.R. §589.2000.
3
Adding protein (derived from animals or plants) to feed is a common nutritional practice used to speed
animal growth.
United States Government Accountability Office
Washington, DC 20548
2 GAO-06-157R FDA Feed Testing Program
industry.4 In February 2005, we issued a follow-up report that examined the
effectiveness of FDA’s actions since the 2002 report to ensure industry compliance with
the feed-ban rule and protect U.S. cattle from BSE.5 Our report concluded that while
FDA has taken a number of positive steps, its processes still have room for improvement.
Our February 2005 report also noted that FDA had begun a small, discrete feed testing
program in August 2003. We reported that we would provide information on this new
feed testing program, which FDA described as a unique effort, once FDA provided us
with data on the feed tests. FDA later gave us the information we required to examine
those feed testing activities. Accordingly, this report assesses FDA’s small feed testing
program and examines the extent to which this feed testing program helps FDA better
assure industry compliance with the feed-ban rule. This report is the final component of
our follow-up work on FDA’s BSE prevention efforts.
FDA established the feed testing program in an assignment memorandum issued in
August 2003, entitled Assignment Memorandum—Sample Assignment for Domestic
Products, which contained instructions for implementing the program. The purpose of
the feed testing program was to collect and analyze cattle and other types of animal feed
and feed ingredients to determine whether feed that could be fed to cattle might contain
material prohibited by FDA’s feed-ban rule. Under the program, FDA collected 641 feed
samples through the end of fiscal year 2004 and planned to collect 900 feed samples
during fiscal year 2005.
The 2003 guidance gave FDA’s district offices responsibility for collecting samples and
submitting them to an FDA laboratory where analysts test the samples using a procedure
called feed microscopy—a visual (microscopic) examination for potentially prohibited
material, such as particles of bone, hair, or muscle fiber from certain animals. If an
analyst detects what appears to be prohibited material, the findings are confirmed by a
second analyst. According to FDA officials, some samples were tested using a more
specialized method called polymerase chain reaction (PCR), a test that FDA has been
piloting, which can differentiate ruminant DNA from other animal DNA.6
The guidance noted that because FDA had designated a number of cattle-derived
exemptions to the feed-ban rule, including blood, milk protein, and plate waste, the
laboratory tests could not definitively determine violations but, rather, could identify
potential violations. The guidance directs the districts to conduct follow-up reviews on
each potential violation to determine whether the facility represented by the sample
actually violates the feed ban. On the basis of the follow-up reviews, the districts assign
final compliance determinations—that the facility where the sample was collected has
complied with or has violated the feed-ban rule.
In June 2005, FDA issued a directive that all feed sample analysis and follow-up actions
4GAO, Mad Cow Disease: Improvements in the Animal Feed Ban and Other Regulatory Areas Would
Strengthen U.S. Prevention Efforts, GAO-02-183 (Washington, D.C.: Jan. 25, 2002).
5
GAO, Mad Cow Disease: FDA’s Management of the Feed Ban Has Improved, but Oversight Weaknesses
Continue to Limit Program Effectiveness, GAO-05-101, (Washington, D.C.: Feb. 25, 2005).
6The PCR test works by aiding in the differentiation of mitochondrial DNA between animal species.
3 GAO-06-157R FDA Feed Testing Program
be recorded in FDA’s central data system—the Field Accomplishments and Compliance
Tracking System (FACTS)—and that districts complete follow-up reviews of potential
violations within 30 working days. In July 2005, FDA issued a revised assignment
memorandum that, among other things, enhances the testing protocol by adopting the
PCR test for sample retesting and directs districts to provide sufficient narrative
explanation in FACTS to explain their final determination on samples that laboratories
identify as potential violations.
For the purpose of this report, we use the term "feed testing program" to distinguish the
samples FDA collected for the feed-testing assignments from samples FDA and states
collected in conjunction with routine BSE inspections. We included only the samples
that FDA collected for the assignments. To examine the extent to which FDA’s feed
testing program provides better assurance of industry compliance with the feed-ban rule,
we reviewed FDA’s data on 1,206 samples collected through June 2005. We identified
989 feed samples collected by FDA’s district offices and analyzed by FDA laboratories
between August 2003 and June 2005, under the feed testing assignment/program
implemented under the August 2003 guidance document. We compared sample
collection, analysis, and follow-up with the program instructions in the August 2003
assignment memorandum. In order to assess FDA’s timeliness in analyzing feed samples
and to determine results of these analyses, we analyzed data on feed sample collection
and laboratory analysis maintained in FACTS on the 989 feed samples. In order to assess
the types of follow-up activities carried out by the districts and the basis for their final
determinations on potential violations, we obtained and analyzed additional electronic
files from FDA districts and discussed those activities and determinations with officials
in the 19 FDA district offices. We also obtained detailed district-specific data and
information on sample collection, follow-up, and enforcement activities in interviews
with the officials in the 19 FDA district offices and discussed this information with FDA
headquarters officials. To assess the reliability of the FACTS data, we analyzed the feed
sample records in this database as of June 7, 2005. We analyzed the data to identify
problems with completeness, accuracy, or timeliness of data entry, and reviewed system
documentation on controls. We determined that the data were sufficiently reliable for
the purposes of this report. The testing program data assessed for this report, including
documentation in FACTS, spreadsheets maintained by individual district offices,
documents describing district follow-up actions for individual samples, and all written
guidance documents, were provided in response to our specific requests for all such
documentation and data related to the feed testing program. Finally, we examined the
feed testing program guidance that FDA provided in the June 2005 field management
directive and the July 2005 assignment memorandum and compared it with the
instructions and guidance FDA provided in the August 2003 memorandum. We
performed our work from February through August 2005 in accordance with generally
accepted government auditing standards. Our work included an assessment of FDA’s
feed testing program data reliability and internal controls.
Results in Brief
The feed testing program is a small part of FDA’s BSE oversight effort and is one of
several methods FDA uses to monitor for compliance with the feed-ban rule. However,
4 GAO-06-157R FDA Feed Testing Program
several weaknesses in the design and implementation of the feed testing program need to
be addressed to improve its effectiveness. Specifically, under the program guidance,
• FDA did not require districts to document their follow-up reviews or the basis for
their final determinations on samples that the laboratories identified as
potentially containing banned protein products. Although the districts may have
conducted rigorous follow-up and exercised sound judgment, the basis for their
decisions cannot be reviewed and confirmed.
• For nearly half the 989 samples, FDA took longer than 30 days from the date the
sample was collected until the date the laboratory completed its analysis—
including 21 samples that took longer than 100 days. This extended period does
not include the time FDA’s districts would have spent following up on samples
that indicated potential violations. FDA and industry agree that cattle feed is
consumed very quickly. By the time FDA conducted its follow up to determine
whether a violation had occurred, the feed may have been consumed.
• FDA managers in headquarters did not adequately oversee the feed testing
program. Specifically, FDA managers did not receive periodic reports or have
other oversight controls in place to assure that the program was implemented
correctly. Moreover, FDA did not identify intended program goals and, as a
result, does not know whether or to what extent the feed testing program is
contributing to the agency’s BSE oversight efforts.
FDA’s June 2005 directive and July 2005 revised instructions—issued nearly 2 years into
the program—includes (1) a requirement that follow-up actions and compliance
determinations be fully documented in FDA’s centralized FACTS compliance tracking
system with sufficient explanation to allow the reader to understand the basis for the
decision and (2) a time limit for districts to complete follow-up reviews.
To ensure that the feed testing program contributes to FDA’s BSE oversight efforts, we
are recommending that FDA (1) fully implement the June 2005 field management
directive and July 2005 assignment memorandum, (2) assure that districts and
laboratories adhere to time limits on collecting samples, completing sample analysis, and
carrying out follow-up activities to minimize cattle’s exposure to potentially
contaminated feed, and (3) require sufficient oversight by headquarters managers to
assure the program is achieving its intended goals.
In commenting on a draft of this report, FDA expressed concern that GAO was issuing a
report that focused on one small aspect of FDA’s BSE oversight efforts. We agree that it
is a small component of FDA’s overall efforts, but it vies for FDA’s limited BSE oversight
resources. Furthermore, as we pointed out in our more comprehensive February 2005
report, we looked at this small program separately because FDA did not provide program
data in time for its inclusion in the broader report. FDA also disagreed with two of our
recommendations in a draft of this report: that it set a time period for laboratories to
complete sample analyses and that headquarters managers exercise sufficient oversight
to assure the program operates as intended. FDA indicated that it had some target
timeframes for laboratories. Because we could not pinpoint where delays were
occurring, we revised our recommendation to address the need to minimize overall
time—from sample collection through analysis and follow-up activities—in order to
minimize cattle’s exposure to potentially dangerous feed. With regard to our
recommendation for better management oversight, FDA disagreed with our assertion
that the program was not sufficiently monitored and noted the activities its managers
have undertaken. We modified that recommendation to clarify what we believe is
needed in terms of management oversight.
SNIP...FULL TEXT 29 PAGES ;
http://www.gao.gov/new.items/d06157r.pdf
Mad Cow Disease: An Evaluation of a Small Feed Testing Program FDA Implemented in 2003 With Recommendations for Making the Program a Better Oversight Tool. GAO-06-157R, October 11
http://www.gao.gov/cgi-bin/getrpt?GAO-06-157R
Docket No, 04-047-l Regulatory Identification No. (RIN) 091O-AF46 NEW BSE SAFEGUARDS (comment submission)
https://web01.aphis.usda.gov/regpublic.nsf/0/eff9eff1f7c5cf2b87256ecf000df08d?OpenDocument
Docket No. 03-080-1 -- USDA ISSUES PROPOSED RULE TO ALLOW LIVE ANIMAL
IMPORTS FROM CANADA
https://web01.aphis.usda.gov/BSEcom.nsf/0/b78ba677e2b0c12185256dd300649f9d?OpenDocument&AutoFramed
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
PDF]Freas, William TSS SUBMISSION
File Format: PDF/Adobe Acrobat -
Page 1. J Freas, William From: Sent: To: Subject: Terry S. Singeltary
Sr. [[email protected]] Monday, January 08,200l 3:03 PM freas ...
http://www.fda.gov/ohrms/dockets/ac/01/slides/3681s2_09.pdf
Asante/Collinge et al, that BSE transmission to the 129-methionine
genotype can lead to an alternate phenotype that is indistinguishable
from type 2 PrPSc, the commonest _sporadic_ CJD;
http://www.fda.gov/ohrms/dockets/ac/03/slides/3923s1_OPH.htm
Docket No, 04-047-l Regulatory Identification No. (RIN) 091O-AF46 NEW BSE SAFEGUARDS (comment submission)https://web01.aphis.usda.gov/regpublic.nsf/0/eff9eff1f7c5cf2b87256ecf000df08d?OpenDocument[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 Cattle03-025IFA03-025IFA-2Terry S. SingeltaryPage 1 of 17From: Terry S. Singeltary Sr. [[email protected]]Sent: Thursday, September 08, 2005 6:17 PMTo: [email protected]: [Docket No. 03-025IFA] FSIS Prohibition of the Use of Specified Risk Materials for Human Food and Requirementsfor the Disposition of Non-Ambulatory Disabled CattleGreetings 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 andRequirements for the Disposition of Non-Ambulatory Disabled CattleTHE BSE/TSE SUB CLINICAL Non-Ambulatory Disabled CattleBroken bones and such may be the first signs of a sub clinical BSE/TSE Non-Ambulatory Disabled Cattle ;SUB CLINICAL PRION INFECTIONMRC-43-00Issued: Monday, 28 August 2000NEW EVIDENCE OF SUB-CLINICAL PRION INFECTION: IMPORTANT RESEARCHFINDINGS RELEVANT TO CJD AND BSEA team of researchers led by Professor John Collinge at the MedicalResearch Council Prion Unit1 report today in the Proceedings of theNational Academy of Sciences, on new evidence for the existence of a?sub-clinical? form of BSE in mice which was unknown until now.
snip...full text;
9/13/2005
http://www.fsis.usda.gov/OPPDE/Comments/03-025IFA/03-025IFA-2.pdf
TSS
Link: FULL TEXT GAO MAD COW FEED USA REPORT 2005
http://www.gao.gov/new.items/d06157r.pdf
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TSS