Greetings,
Since posting this recall below a few days ago ;
Thursday, August 27, 2009 MAD COW FEED RECALL 2009 Product may have contained prohibited materials (208,820 LBS. THAT COULD CONTAINED PRIONS...TSS) without cautionary statement Subject: 2009 Product may have contained prohibited materials (THAT COULD CONTAIN PRIONS...TSS) without cautionary statement on the label
PRODUCT Bulk Whole Barley, Recall # V-256-2009
CODE No code or lot number.
RECALLING FIRM/MANUFACTURER Mars Petcare US, Clinton, OK, by telephone on May 21, 2009. Firm initiated recall is complete.
REASON Product may have contained prohibited materials without cautionary statement on the label.
VOLUME OF PRODUCT IN COMMERCE 208,820 pounds
DISTRIBUTION TX END OF ENFORCEMENT REPORT FOR AUGUST 26, 2009
###
http://www.fda.gov/Safety/Recalls/EnforcementReports/ucm180348.htm
Greetings,
I saw this latest mad cow feed warning letter and notice a few changes. thought it looked a little fishy, so looking further i find it seems that now the FDA et al could not say mad cow or BSE, even if they had a mouth full of it, this is exactly what this warning letter recall is about, recalling potential mad cow feed, that might contain prions, that might get fed to cattle or other ruminants. this is the poorest i have seen yet on a warning letter with lack of information. compare it to the feed ban recall warning letter at the bottom. ALSO, This violator violations were so bad, they required an OAI on 05/28/2009, but you would not have noticed this by it's warning letter. SO, you have 208,820 pounds more of suspect mad cow feed IN COMMERCE, feeding to pets, or maybe cattle, who knows, no warning label on it. NOTHING HAS CHANGED, IT'S ALL STILL VOLUNTARY BSe. ...
I reported this back on Saturday, June 13, 2009 ;
DAL-DO 3007064862 Mars Petcare US #1 Mars Road Clinton OK 73601 OPR PF HP 05/28/2009 OAI Y
snip...
An OAI inspection classification occurs when significant objectionable conditions or practices were found and regulatory sanctions are warranted in order to address the establishment's lack of compliance with the regulation. An example of an OAI inspection classification would be findings of manufacturing procedures insufficient to ensure that ruminant feed is not contaminated with prohibited material. Inspections classified with OAI violations will be promptly re-inspected following the regulatory sanctions to determine whether adequate corrective actions have been implemented
snip...
http://madcowfeed.blogspot.com/2009/06/bse-feed-violations-usa-update-from.html
snip...end
see full text ;
http://madcowfeed.blogspot.com/2009/08/mad-cow-feed-recall-2009-product-may.html
Since posting this, i thought i might get the FDA to clarify this recall. NO CHANCE, TOP SECRET, MUST REQUEST FOIA ;
From: Terry S. Singeltary Sr. [mailto:flounder9@verizon.net] Sent: Thursday, August 27, 2009 1:05 PM To: Pritchett, Burt Subject: hello Mr. Pritchett Sir !!! mad cow feed question
Hello Mr. Pritchett,
I am trying to find out more information on this recall ;
PRODUCT Bulk Whole Barley, Recall # V-256-2009
CODE No code or lot number.
RECALLING FIRM/MANUFACTURER Mars Petcare US, Clinton, OK, by telephone on May 21, 2009. Firm initiated recall is complete.
REASON Product may have contained prohibited materials without cautionary statement on the label.
VOLUME OF PRODUCT IN COMMERCE 208,820 pounds
DISTRIBUTION TX END OF ENFORCEMENT REPORT FOR AUGUST 26, 2009
###
http://www.fda.gov/Safety/Recalls/EnforcementReports/ucm180348.htm
NO doubt, this is a BSE feed ban violation of some sort, but exactly what ???
was the bulk barley mixed with dog food, cat food, fish food, deer or elk food or what ???
this is the poorest i have seen yet on a warning letter with lack of information. compare it to the feed ban recall warning letter at the bottom. ALSO, This violator violations were so bad, they required an OAI on 05/28/2009, but you would not have noticed this by it's warning letter. SO, you have 208,820 pounds more of suspect mad cow feed IN COMMERCE, feeding to pets, or maybe cattle, who knows, no warning label on it. NOTHING HAS CHANGED, IT'S ALL STILL VOLUNTARY BSe. ...
I reported this back on Saturday, June 13, 2009 ;
DAL-DO 3007064862 Mars Petcare US #1 Mars Road Clinton OK 73601 OPR PF HP 05/28/2009 OAI Y
snip...
An OAI inspection classification occurs when significant objectionable conditions or practices were found and regulatory sanctions are warranted in order to address the establishment's lack of compliance with the regulation. An example of an OAI inspection classification would be findings of manufacturing procedures insufficient to ensure that ruminant feed is not contaminated with prohibited material. Inspections classified with OAI violations will be promptly re-inspected following the regulatory sanctions to determine whether adequate corrective actions have been implemented
snip...end
Myself and many others are wondering just exactly what this recall is all about ???
was the OAI related to this recall, or was it a separate offence ???
REASON Product may have contained prohibited materials without cautionary statement on the label.
exactly what are we speaking of Sir ???
thank you,
curious terry here///
FDA REPLY TO TSS ;
----- Original Message -----
From: Pritchett, Burt
To: Terry S. Singeltary Sr.
Sent: Thursday, August 27, 2009 3:26 PM
Subject: RE: hello Mr. Pritchett Sir !!! mad cow feed question
Terry,
That is the extent of the public information on the recall. If you wish to obtain additional information, you should submit a freedom of information act request through our communications staff. You could send an email request to: mhtml:%7B33B38F65-8D2E-434D-8F9B-8BDCD77D3066%7Dmid://00000090/!x-usc:mailto:CVMHomeP@cvm.fda.gov
Burt
--------------------------------------------------------------------------------
O.K. THAT'S JUST WHAT I DID ;
----- Original Message -----
From: Terry S. Singeltary Sr. T
o: mhtml:%7B33B38F65-8D2E-434D-8F9B-8BDCD77D3066%7Dmid://00000090/!x-usc:mailto:CVMHomeP@cvm.fda.gov
Cc: mhtml:%7B33B38F65-8D2E-434D-8F9B-8BDCD77D3066%7Dmid://00000090/!x-usc:mailto:FOIASTAFF@oig.usda.gov ; mhtml:%7B33B38F65-8D2E-434D-8F9B-8BDCD77D3066%7Dmid://00000090/!x-usc:mailto:paffairs@oig.hhs.gov ; mhtml:%7B33B38F65-8D2E-434D-8F9B-8BDCD77D3066%7Dmid://00000090/!x-usc:mailto:HHSTips@oig.hhs.gov ; mhtml:%7B33B38F65-8D2E-434D-8F9B-8BDCD77D3066%7Dmid://00000090/!x-usc:mailto:contactOIG@hhsc.state.tx.us ; mhtml:%7B33B38F65-8D2E-434D-8F9B-8BDCD77D3066%7Dmid://00000090/!x-usc:mailto:phyllis.fong@oig.usda.gov
Sent: Friday, August 28, 2009 12:17 PM
Subject: FOIA REQUEST ON FEED RECALL PRODUCT Bulk Whole Barley, Recall # V-256-2009 DISTRIBUTION TX END OF ENFORCEMENT REPORT FOR AUGUST 26, 2009
Greetings FDA and the Honorable Phyllis Fong et al @ OIG,
FOIA REQUEST PLEASE !
I was told that the only way to find any more information on the following recall, i would have to submit a FOIA ? why, i do not know ?
The last FOIA i worked on took over 6 years ;
http://foiamadsheepmadrivervalley.blogspot.com/
i hope this one does not take this long to get any results ;
----- Original Message -----
From: Pritchett, Burt
To: Terry S. Singeltary Sr.
Sent: Thursday, August 27, 2009 3:26 PM
Subject: RE: hello Mr. Pritchett Sir !!! mad cow feed question
Terry,
That is the extent of the public information on the recall. If you wish to obtain additional information, you should submit a freedom of information act request through our communications staff. You could send an email request to: mhtml:%7B33B38F65-8D2E-434D-8F9B-8BDCD77D3066%7Dmid://00000090/!x-usc:mailto:CVMHomeP@cvm.fda.gov
Burt
================end...TSS
Greetings again FDA, OIG et al,
I am trying to find out more information on this recall ;
PRODUCT Bulk Whole Barley, Recall # V-256-2009
CODE No code or lot number.
RECALLING FIRM/MANUFACTURER Mars Petcare US, Clinton, OK, by telephone on May 21, 2009. Firm initiated recall is complete.
REASON Product may have contained prohibited materials without cautionary statement on the label.
VOLUME OF PRODUCT IN COMMERCE 208,820 pounds
DISTRIBUTION TX END OF ENFORCEMENT REPORT FOR AUGUST 26, 2009
###
http://www.fda.gov/Safety/Recalls/EnforcementReports/ucm180348.htm
IS this is a BSE/TSE feed ban violation of some sort, or exactly what ?
was the bulk barley mixed with dog food, cat food, fish food, deer or elk food or what ?
why no code or lot number ?
how does one expect to regain this banned product from commerce, IF one does not know what product contains said recall product i.e. was the bulk barely actually just bulk barely, or could it have possibly been salvaged pet foods of some sort ?
or, how did "prohibited materials" get into alleged "whole bulk barley" ? (confused)
how many different products is the 'bulk barely' mixed with ?
Myself and many others are wondering just exactly what this recall is all about ?
was the OAI related to this recall, or was it a separate offence ?
this is the poorest i have seen yet on a warning letter with lack of information.
ALSO, This violator violations were so bad, they required an OAI on 05/28/2009, but you would not have noticed this by it's warning letter. SO, you have 208,820 pounds more of suspect mad cow feed IN COMMERCE, feeding to pets, or maybe cattle, who knows, no warning label on it. NOTHING HAS CHANGED, IT'S ALL STILL VOLUNTARY BSe. ...
I reported this back on Saturday, June 13, 2009 ;
DAL-DO 3007064862 Mars Petcare US #1 Mars Road Clinton OK 73601 OPR PF HP 05/28/2009 OAI Y
snip...
An OAI inspection classification occurs when significant objectionable conditions or practices were found and regulatory sanctions are warranted in order to address the establishment's lack of compliance with the regulation. An example of an OAI inspection classification would be findings of manufacturing procedures insufficient to ensure that ruminant feed is not contaminated with prohibited material. Inspections classified with OAI violations will be promptly re-inspected following the regulatory sanctions to determine whether adequate corrective actions have been implemented
snip...end
REASON Product may have contained prohibited materials without cautionary statement on the label.
exactly what are we speaking of here, and in how many different products ???
Thank You,
kindest regards,
Terry S. Singeltary Sr.
Saturday, June 13, 2009 BSE FEED VIOLATIONS USA UPDATE From 01/01/2009 To 06/10/2009
http://madcowfeed.blogspot.com/2009/06/bse-feed-violations-usa-update-from.html
Terry S. Singeltary Sr.
P.O. Box 42
Bacliff, Texas USA 77518
end...TSS
ABOUT 20 MINUTES LATER I GET THIS BACK FROM FDA ;
----- Original Message -----
From: CVM HomePage
To: Terry S. Singeltary Sr.
Cc: Pritchett, Burt
Sent: Friday, August 28, 2009 12:40 PM
Subject: RE: FOIA REQUEST ON FEED RECALL PRODUCT Bulk Whole Barley, Recall # V-256-2009 DISTRIBUTION TX END OF ENFORCEMENT REPORT FOR AUGUST 26, 2009
Dear Terry Singletary:
Thank you for contacting the Center for Veterinary Medicine Home Page.
Please see http://www.fda.gov/RegulatoryInformation/FOI/HowtoMakeaFOIARequest/default.htm for information on how to file a Freedom of Information (FOI) request.
I hope this is helpful.
Sincerely,
CVM Home Page
===========================
O.K., BACK to the drawing board, remember, the last FOIA i requested took 6 plus years, so this was submitted again by fax yesterday FOIA request as follows ;
----- Original Message -----
From: Terry S. Singeltary Sr.
To: TERRY SINGELTARY
Sent: Friday, August 28, 2009 1:10 PM
Subject: FOIA REQUEST ON FEED RECALL PRODUCT Bulk Whole Barley, Recall # V-256-2009 DISTRIBUTION TX END OF ENFORCEMENT REPORT FOR AUGUST 26, 2009
August 28, 2009
FOIA REQUEST ON FEED RECALL PRODUCT Bulk Whole Barley, Recall # V-256-2009 DISTRIBUTION TX END OF ENFORCEMENT REPORT FOR AUGUST 26, 2009
TO:
Food and Drug Administration
Division of Freedom of Information (HFI-35)
Office of Shared Services
Office of Public Information and Library Services
5600 Fishers Lane
Rockville, MD 20857
Or requests may be sent via fax to: fax number 301-443-1726 or 301-443-1719. If experience difficulty sending a fax, please call (301) 443-2414.
FROM:
Terry S. Singeltary Sr.
P.O. Box 42
Bacliff, Texas USA 77518
----- Original Message -----
From: Terry S. Singeltary Sr.
To: mhtml:%7B33B38F65-8D2E-434D-8F9B-8BDCD77D3066%7Dmid://00000090/!x-usc:mailto:CVMHomeP@cvm.fda.gov
Cc: mhtml:%7B33B38F65-8D2E-434D-8F9B-8BDCD77D3066%7Dmid://00000090/!x-usc:mailto:FOIASTAFF@oig.usda.gov ; mhtml:%7B33B38F65-8D2E-434D-8F9B-8BDCD77D3066%7Dmid://00000090/!x-usc:mailto:paffairs@oig.hhs.gov ; mhtml:%7B33B38F65-8D2E-434D-8F9B-8BDCD77D3066%7Dmid://00000090/!x-usc:mailto:HHSTips@oig.hhs.gov ; mhtml:%7B33B38F65-8D2E-434D-8F9B-8BDCD77D3066%7Dmid://00000090/!x-usc:mailto:phyllis.fong@oig.usda.gov
Sent: Friday, August 28, 2009 12:17 PM Subject: FOIA REQUEST ON FEED RECALL PRODUCT Bulk Whole Barley, Recall # V-256-2009 DISTRIBUTION TX END OF ENFORCEMENT REPORT FOR AUGUST 26, 2009
Greetings FDA and the Honorable Phyllis Fong et al @ OIG,
FOIA REQUEST PLEASE !
I was told that the only way to find any more information on the following recall, i would have to submit a FOIA ? why, i do not know ?
The last FOIA i worked on took over 6 years ;
http://foiamadsheepmadrivervalley.blogspot.com/
i hope this one does not take this long to get any results ;
----- Original Message -----
From: Pritchett, Burt
To: Terry S. Singeltary Sr.
Sent: Thursday, August 27, 2009 3:26 PM
Subject: RE: hello Mr. Pritchett Sir !!! mad cow feed question
Terry,
That is the extent of the public information on the recall. If you wish to obtain additional information, you should submit a freedom of information act request through our communications staff. You could send an email request to:
mhtml:%7B33B38F65-8D2E-434D-8F9B-8BDCD77D3066%7Dmid://00000090/!x-usc:mailto:CVMHomeP@cvm.fda.gov
Burt
================end...TSS
Greetings again FDA, OIG et al,
I am trying to find out more information on this recall ;
PRODUCT Bulk Whole Barley, Recall # V-256-2009
CODE No code or lot number.
RECALLING FIRM/MANUFACTURER Mars Petcare US, Clinton, OK, by telephone on May 21, 2009. Firm initiated recall is complete.
REASON Product may have contained prohibited materials without cautionary statement on the label.
VOLUME OF PRODUCT IN COMMERCE 208,820 pounds
DISTRIBUTION TX END OF ENFORCEMENT REPORT FOR AUGUST 26, 2009
###
http://www.fda.gov/Safety/Recalls/EnforcementReports/ucm180348.htm
IS this is a BSE/TSE feed ban violation of some sort, or exactly what ?
was the bulk barley mixed with dog food, cat food, fish food, deer or elk food or what ?
why no code or lot number ?
how does one expect to regain this banned product from commerce, IF one does not know what product contains said recall product i.e. was the bulk barely actually just bulk barely, or could it have possibly been salvaged pet foods of some sort ?
or, how did "prohibited materials" get into alleged "whole bulk barley" ? (confused)
how many different products is the 'bulk barely' mixed with ?
Myself and many others are wondering just exactly what this recall is all about ?
was the OAI related to this recall, or was it a separate offence ?
this is the poorest i have seen yet on a warning letter with lack of information.
ALSO, This violator violations were so bad, they required an OAI on 05/28/2009, but you would not have noticed this by it's warning letter. SO, you have 208,820 pounds more of suspect mad cow feed IN COMMERCE, feeding to pets, or maybe cattle, who knows, no warning label on it. NOTHING HAS CHANGED, IT'S ALL STILL VOLUNTARY BSe. ...
I reported this back on Saturday, June 13, 2009 ;
DAL-DO 3007064862 Mars Petcare US #1 Mars Road Clinton OK 73601 OPR PF HP 05/28/2009 OAI Y
snip...
An OAI inspection classification occurs when significant objectionable conditions or practices were found and regulatory sanctions are warranted in order to address the establishment's lack of compliance with the regulation. An example of an OAI inspection classification would be findings of manufacturing procedures insufficient to ensure that ruminant feed is not contaminated with prohibited material. Inspections classified with OAI violations will be promptly re-inspected following the regulatory sanctions to determine whether adequate corrective actions have been implemented
snip...end
REASON Product may have contained prohibited materials without cautionary statement on the label.
exactly what are we speaking of here, and in how many different products ???
Thank You,
kindest regards,
Terry S. Singeltary Sr.
How to Make a FOIA Request All FOIA requests must be in writing and should include the following information:
A. Requestor's name, address, and telephone number.
Terry S. Singeltary Sr.
P.O. Box 42
Bacliff, Texas USA 77518
XXX-XXX-XXXX
B. A description of the records being sought. The records should be identified as specifically as possible. A request for specific records that are releasable to the public can be processed much more quickly than a request for "all information" on a particular subject. Also fees for a more specific and limited request will generally be less.
SEE ABOVE FOIA SPECIFIC REQUEST OF RECORDS. ...TSS
C. Separate requests should be submitted for each firm or product involved.
DUE TO THE LACK OF INFORMATION IN THE ORIGINAL WARNING LETTER, THIS IS NOT POSSIBLE. ...TSS
D. A statement concerning willingness to pay fees, including any limitations.
I CANNOT PAY ANYTHING. I AM DISABLED AND ON FIXED INCOME. THIS INFORMATION I REQUEST IS FOR ME AND THE PUBLIC. ...TSS
Questions relating to FOI requests may be addressed to the Division of the Freedom of Information Offices at 301-827-6567.
All FOIA requests must be in writing. At this time, FDA does not accept FOIA requests sent via e-mail. Requests should be mailed to the following address:
Food and Drug Administration
Division of Freedom of Information (HFI-35)
Office of Shared Services
Office of Public Information and Library Services
5600 Fishers Lane
Rockville, MD 20857
Or requests may be sent via fax to: fax number 301-443-1726 or 301-443-1719. If experience difficulty sending a fax, please call (301) 443-2414.
FAXED TO FDA AND RECEIVED ON AUGUST 28, 2009
Saturday, August 29, 2009
Thursday, August 27, 2009
MAD COW FEED RECALL 2009 Product may have contained prohibited materials (208,820 LBS. THAT COULD CONTAINED PRIONS...TSS) without cautionary statement
Subject: 2009 Product may have contained prohibited materials (THAT COULD CONTAIN PRIONS...TSS) without cautionary statement on the label
PRODUCT Bulk Whole Barley, Recall # V-256-2009
CODE No code or lot number.
RECALLING FIRM/MANUFACTURER Mars Petcare US, Clinton, OK, by telephone on May 21, 2009. Firm initiated recall is complete.
REASON Product may have contained prohibited materials without cautionary statement on the label.
VOLUME OF PRODUCT IN COMMERCE 208,820 pounds
DISTRIBUTION TX END OF ENFORCEMENT REPORT FOR AUGUST 26, 2009
###
http://www.fda.gov/Safety/Recalls/EnforcementReports/ucm180348.htm
Greetings,
I saw this latest mad cow feed warning letter and notice a few changes. thought it looked a little fishy, so looking further i find it seems that now the FDA et al could not say mad cow or BSE, even if they had a mouth full of it, this is exactly what this warning letter recall is about, recalling potential mad cow feed, that might contain prions, that might get fed to cattle or other ruminants. this is the poorest i have seen yet on a warning letter with lack of information. compare it to the feed ban recall warning letter at the bottom. ALSO, This violator violations were so bad, they required an OAI on 05/28/2009, but you would not have noticed this by it's warning letter. SO, you have 208,820 pounds more of suspect mad cow feed IN COMMERCE, feeding to pets, or maybe cattle, who knows, no warning label on it. NOTHING HAS CHANGED, IT'S ALL STILL VOLUNTARY BSe. ...
I reported this back on Saturday, June 13, 2009 ;
DAL-DO 3007064862 Mars Petcare US #1 Mars Road Clinton OK 73601 OPR PF HP 05/28/2009 OAI Y
snip...
An OAI inspection classification occurs when significant objectionable conditions or practices were found and regulatory sanctions are warranted in order to address the establishment's lack of compliance with the regulation. An example of an OAI inspection classification would be findings of manufacturing procedures insufficient to ensure that ruminant feed is not contaminated with prohibited material. Inspections classified with OAI violations will be promptly re-inspected following the regulatory sanctions to determine whether adequate corrective actions have been implemented
snip...
http://madcowfeed.blogspot.com/2009/06/bse-feed-violations-usa-update-from.html
I SUPPOSE, IF ONE WAITS LONG ENOUGH BEFORE ANNOUNCING RECALL, ONE MIGHT HOPE ALL MAD COW FEED IS FED OUT INTO COMMERCE $$$
#70
GUIDANCE FOR INDUSTRY
SMALL ENTITIES COMPLIANCE GUIDE FOR FEEDERS OF RUMINANT ANIMALS WITHOUT ON-FARM FEED MIXING OPERATIONS
(This version of the guidance replaces the version that was made available in February 1998. This guidance document has been revised to update contact information and provide new requirements regarding the use of tallow in ruminant feed.)
Submit comments on this guidance at any time. Submit written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852. Comments may also be submitted electronically on the Internet at http://www.regulations.gov.
For questions regarding this guidance document, contact Shannon Jordre, Division of Compliance (HFV-230), U.S. Food and Drug Administration, Center for Veterinary Medicine, 7519 Standish Place, MPN-4, Rockville, MD 20855, (240) 276-9229.
Additional copies of this guidance document may be requested from the Communications Staff, HFV-12, Center for Veterinary Medicine, U.S. Food and Drug Administration, 7519 Standish Place, Rockville, MD 20855, and may be viewed on the Internet at
http://www.fda.gov/AnimalVeterinary/default.htm.
U.S. Department of Health and Human Services Food and Drug Administration Center for Veterinary Medicine July 13, 2009
CONTAINS NON-BINDING RECOMMENDATIONS
Guidance for Industry
SMALL ENTITIES COMPLIANCE GUIDE FOR FEEDERS OF RUMINANT ANIMALS WITHOUT ON-FARM FEED MIXING OPERATIONS1
This guidance document represents the Food and Drug Administration’s (FDA’s) current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. You can use an alterative approach if the approach satisfies the requirements of the applicable statutes and regulations. If you want to discuss an alternative approach, contact the FDA staff responsible for implementing this guidance. If you cannot identify the appropriate FDA staff, call the appropriate number listed on the title page of this guidance.
Introduction
On April 25, 2008, FDA published a final rule in the Federal Register, entitled “Substances Prohibited from Use in Animal Food or Feed” (73 FR 22719). See also 73 FR 18626; April 24, 2009. This final rule established a new regulation at 21 CFR 589.2001 entitled, “Cattle Materials Prohibited in Animal Food or Feed to Prevent the Transmission of Bovine Spongiform Encephalopathy”. 21 CFR 589.2001 prohibits the use of certain cattle materials in the feed of all animals and is aimed primarily at rendering operations. This new rule also amended the previously existing BSE regulation, 21 CFR 589.2000 entitled, “Animal Proteins Prohibited in Ruminant Feed“, which addresses only the feeding of ruminant animals.
The Food and Drug Administration (FDA) has prepared this Small Entities Compliance Guide in accordance with section 212 of the Small Business Regulatory Enforcement Fairness Act of 1996. (Public Law 104-121). This guidance document represents the agency's current thinking on compliance with the regulation 21 CFR 589.2000 "Animal Proteins Prohibited in Ruminant Feed", as amended during the recent rule-making process, and how the regulation impacts livestock producers feeding ruminant animals.
FDA’s guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word “should” in Agency guidances means that something is suggested or recommended, but not required.
What Is The Purpose And Scope Of This Regulation, 21 CFR 589.2000?
This regulation is designed to prevent the establishment and amplification of Bovine Spongiform Encephalopathy (BSE), sometimes referred to as “Mad Cow Disease,” through animal feed. The
1 This guidance has been prepared by the Office of Surveillance and Compliance in the Center for Veterinary Medicine.
2
CONTAINS NON-BINDING RECOMMENDATIONS
regulation prohibits the use of certain proteins derived from mammalian tissue in feeding ruminant animals. An example is meat and bone meal derived from cattle. However, certain products are exempt from this regulation.
• The following protein products derived from mammals are exempt:
• Blood and blood products
• Gelatin
• Milk products (milk and milk proteins)
• Pure porcine (pork) or pure equine (horse) protein products
• Inspected meat products, such as plate waste, which have been cooked and offered for human food and further heat processed for animal feed
• The following nonmammalian protein products are exempt:
• Poultry
• Marine (fish)
• Vegetable
• The following products are also exempt because they are not protein or tissue:
• Grease
• Tallow that contains no more than 0.15% insoluble impurities2
• Fat3
• Amino acids
• Vegetable oil
• Dicalcium phosphate
We refer to the exempted products throughout this guide as “nonprohibited material.” We refer to all mammalian protein that is not exempted as “prohibited material.”
Prohibited material and/or feeds containing prohibited material cannot be fed to ruminant animals. “Ruminant animals” are any animals with a four-chambered stomach including cattle, sheep, goats, buffalo, elk, and deer.
Is My Operation Affected By 21 CFR 589.2000?
• This regulation applies to livestock feeding operations that feed ruminants. The regulation applies to "establishments and individuals that are responsible for feeding ruminants" to make it clear that all responsible persons, in both large and small feeding operations, are subject to the regulation.
• Examples include dairies, cattle feed lots, calf and lamb raising operations, cattle, sheep, and goat grazing operations.
2 Tallow is defined by 21 CFR 589.2001(b)(5) as the rendered fat of cattle. Tallow that contains more that 0.15% insoluble impurities is considered to be an animal protein prohibited in ruminant feed in 21 CFR 589.2000(a)(1). Such tallow should be labeled with the cautionary statement “Do Not Feed to Cattle or Other Ruminants.”
3 Excludes tallow that contains more than 0.15% insoluble impurities.
3
CONTAINS NON-BINDING RECOMMENDATIONS
• If a feed product intended for ruminants contains animal protein, the protein can consist only of nonprohibited material.
• The Association of American Feed Control Officials (AAFCO) has identified the following ingredients listed in its Official Publication as prohibited material:
• Meat
• Meat By-Products
• Animal Liver
• Dried Meat Solubles
• Fleshings Hydrolysate
• Meat Meal
• Meat and Bone Meal
• Animal By-Product Meal
• Meat Meal Tankage
• Meat and Bone Meal Tankage
• Hydrolyzed Leather Meal
• Hydrolyzed Hair
• Glandular Meal and Extracted Glandular Meal
• Stock/Broth
• Animal Digest
• Cooked Bone Marrow
• Leather Hydrolysate
• Meat Protein Isolate
• Mechanically Separated Bone Marrow
• Unborn Calf Carcasses
• Bone Meal, cooked
• Bone Meal, steamed
• Dehydrated Garbage
• Dehydrated Food-Waste
• Salvage Pet Food
• Distressed Pet Food
Feed and feed ingredients not containing animal proteins are not subject to the regulation.
• Persons who feed prohibited material to ruminants would be subject to regulatory action under the Federal Food, Drug, and Cosmetic Act. Regulatory action could include seizure of inventory, injunction against feeding prohibited material to ruminants, or prosecution.
Note: If you mix your own feed for your ruminant animals, you are subject to additional requirements. Consult the “Small Entities Compliance Guide for Feeders of Ruminant Animals with On-Farm Feed Mixing Operations,” FDA Guidance for Industry 69.
How Do I Comply With 21 CFR 589.2000?
4
CONTAINS NON-BINDING RECOMMENDATIONS
1. Do not feed products labeled with the caution statement “Do not feed to cattle or other ruminants” to your ruminant animals4.
2. Maintain copies of all purchase invoices for ALL feeds received that contain animal protein.
3. Maintain copies of labeling for ALL feeds received containing animal protein products.
4. Keep invoices and labeling available for inspection and copying.
5. Maintain the records for a minimum of one year.
What Other Information Do I Need To Know To Help Me Comply With 21 CFR 589.2000?
• Renderers, protein blenders, and feed manufacturers are required to label products containing prohibited materials with the cautionary statement Do not feed to cattle or other ruminants.
• If you intend to feed only ruminant animals, products with this caution statement should not be available for use in your operation. If the feed does not bear the caution statement but you suspect that it contains prohibited material, do not use it until you are sure that it does not contain such materials.
• If you intend to use a feed containing prohibited material for nonruminant animals, take steps to ensure that the feed will not be fed to ruminants.
• Labeling And Record Keeping
• For bulk shipments it is common practice to provide labeling information on the invoice. In such cases, retaining the invoice is sufficient documentation.
• If the only labeling for a bulk product is on a placard, the placard for each shipment should be retained.
• Feed may also be received in bags or other containers that have attached labeling. In those instances, the labeling should be removed and retained. However, maintenance of only one such labeling piece from each shipment that represents a different product is necessary.
• If the labeling cannot be removed from the bag or other container, it is acceptable to retain a representative bag or a transposed copy of the labeling information from a container that cannot feasibly be stored.
• The records should be legible and readily retrievable.
4 If the product label bears the “Do Not Feed to Animals” statement, take steps to ensure that it is not fed to animals. This product should not have been introduced into the animal feed chain because it is prohibited from use in any animal feed by another rule titled “SUBSTANCES PROHIBITED FROM USE IN ANIMAL FOOD OR FEED” and codified in 21 CFR 589.2001. This rule published on April 25, 2008, with an effective date of April 27, 2009.
5
CONTAINS NON-BINDING RECOMMENDATIONS
• The one year requirement for maintenance of records means one year from the date of the receipt of the product.
• Inspections
• On-farm inspections will be limited but will be needed on a selective basis to trace prohibited material to verify that it is not being shipped to ruminant producers and fed to ruminant animals. For example, on-farm inspection might be necessary as a follow up to a feed mill inspection, to verify that feed not labeled with the cautionary statement is in fact being fed to nonruminant animals.
http://www.fda.gov/downloads/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/UCM052385.pdf
FDA GUIDANCE FOR INDUSTRY 67 This guide replaces those parts of Guidance for Industry 60, June 17, 1997, that applied to renderers.
http://www.fda.gov/downloads/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/ucm052381.pdf
FDA GUIDANCE FOR INDUSTRY 68 This guide replaces those parts of Guidance for Industry 60, June 17, 1997, that applied to protein blenders, feed manufacturers, and distributors. SMALL ENTITIES COMPLIANCE GUIDE FOR PROTEIN BLENDERS, FEED MANUFACTURERS, AND DISTRIBUTORS This document is intended to provide guidance for “ANIMAL PROTEINS PROHIBITED FROM USE IN RUMINANT FEED,” Title 21, Code of Federal Regulations, Part 589.2000, Effective Date: August 4, 1997.
http://www.fda.gov/downloads/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/ucm052382.pdf
NOTHING BUT INK ON PAPER I TELL YOU !
10,000,000+ LBS. of PROHIBITED BANNED MAD COW FEED I.E. BLOOD LACED MBM IN COMMERCE USA 2007
Date: March 21, 2007 at 2:27 pm PST
RECALLS AND FIELD CORRECTIONS: VETERINARY MEDICINES -- CLASS II
___________________________________
PRODUCT
Bulk cattle feed made with recalled Darling's 85% Blood Meal, Flash Dried, Recall # V-024-2007
CODE
Cattle feed delivered between 01/12/2007 and 01/26/2007
RECALLING FIRM/MANUFACTURER
Pfeiffer, Arno, Inc, Greenbush, WI. by conversation on February 5, 2007.
Firm initiated recall is ongoing.
REASON
Blood meal used to make cattle feed was recalled because it was cross- contaminated with prohibited bovine meat and bone meal that had been manufactured on common equipment and labeling did not bear cautionary BSE statement.
VOLUME OF PRODUCT IN COMMERCE
42,090 lbs.
DISTRIBUTION
WI
___________________________________
PRODUCT
Custom dairy premix products: MNM ALL PURPOSE Pellet, HILLSIDE/CDL Prot- Buffer Meal, LEE, M.-CLOSE UP PX Pellet, HIGH DESERT/ GHC LACT Meal, TATARKA, M CUST PROT Meal, SUNRIDGE/CDL PROTEIN Blend, LOURENZO, K PVM DAIRY Meal, DOUBLE B DAIRY/GHC LAC Mineral, WEST PIONT/GHC CLOSEUP Mineral, WEST POINT/GHC LACT Meal, JENKS, J/COMPASS PROTEIN Meal, COPPINI - 8# SPECIAL DAIRY Mix, GULICK, L-LACT Meal (Bulk), TRIPLE J - PROTEIN/LACTATION, ROCK CREEK/GHC MILK Mineral, BETTENCOURT/GHC S.SIDE MK-MN, BETTENCOURT #1/GHC MILK MINR, V&C DAIRY/GHC LACT Meal, VEENSTRA, F/GHC LACT Meal, SMUTNY, A- BYPASS ML W/SMARTA, Recall # V-025-2007
CODE
The firm does not utilize a code - only shipping documentation with commodity and weights identified.
RECALLING FIRM/MANUFACTURER
Rangen, Inc, Buhl, ID, by letters on February 13 and 14, 2007. Firm initiated recall is complete.
REASON
Products manufactured from bulk feed containing blood meal that was cross contaminated with prohibited meat and bone meal and the labeling did not bear cautionary BSE statement.
VOLUME OF PRODUCT IN COMMERCE
9,997,976 lbs.
DISTRIBUTION
ID and NV
END OF ENFORCEMENT REPORT FOR MARCH 21, 2007
http://www.fda.gov/bbs/topics/enforce/2007/ENF00996.html
NEW URL
http://www.fda.gov/Safety/Recalls/EnforcementReports/2007/ucm120446.htm
Thursday, March 19, 2009 MILLIONS AND MILLIONS OF POUNDS OF MAD COW FEED IN COMMERCE USA WITH ONGOING 12 YEARS OF DENIAL NOW, WHY IN THE WORLD DO WE TO TALK ABOUT THIS ANYMORE $$$
http://madcowfeed.blogspot.com/2009/03/millions-and-millions-of-pounds-of-mad.html
Monday, August 17, 2009 FDA asked to ban poultry litter from feed AGAIN 17 Aug 2009 Ban that Poop!
http://madcowfeed.blogspot.com/2009/08/fda-asked-to-ban-poultry-litter-from.html
Saturday, June 13, 2009
Monitoring the occurrence of emerging forms of Creutzfeldt-Jakob disease in the United States 2003 revisited 2009
http://cjdusa.blogspot.com/2009/06/monitoring-occurrence-of-emerging-forms.html
SEE THE VIDEO NOW AT THE BOTTOM OF THE BLOG BELOW ;
http://creutzfeldt-jakob-disease.blogspot.com/2009/07/usa-hiding-mad-cow-disease-victims-as.html
Tuesday, August 18, 2009
BSE-The Untold Story - joe gibbs and singeltary 1999 - 2009
http://madcowusda.blogspot.com/2009/08/bse-untold-story-joe-gibbs-and.html
Sunday, August 09, 2009
CJD...Straight talk with...James Ironside...and...Terry Singeltary... 2009
http://creutzfeldt-jakob-disease.blogspot.com/2009/08/cjdstraight-talk-withjames.html
Thursday, July 10, 2008
A New Prionopathy update July 10, 2008
snip...
DOES ANYONE BESIDES ME SEE A PATTERN YET ???
Vickey Rimmer, 16, DID NOT DIE FROM nvCJD, she died from a form of sporadic CJD, whatever the hell that is. and there have been 16 year old die from sporadic CJD in the USA as well.
SIMPLY PUT, the ukbsenvcjd only theory was wrong from day one. the elderly are expendable, pets and kids are not.
Science was dictated by 'big buisness' after the Vickey Rimmer case with the ukbsenvcjd only myth.
snip...
Sporadic creutzfeldt-jakob disease in two adolescents
http://jnnp.bmj.com/cgi/content/abstract/jnnp.2006.104570v1
see full text sporadic CJD the big lie;
snip...
IT seems we have come full circle from the 'ORIGINAL 10' i.e. the 1st 10 adolescents in the UKBSEnvCJD only theory. and now we find us at the 1st 10 in USA, or is it the first 10, or the tip of the iceburg, many that went undocumented ???
lets look at the full circle, to date ;
http://cjdmadcowbaseoct2007.blogspot.com/2008/07/new-prionopathy-update-july-10-2008.html
Sunday, August 10, 2008 A New Prionopathy OR more of the same old BSe and sporadic CJD
http://creutzfeldt-jakob-disease.blogspot.com/2008/08/new-prionopathy-or-more-of-same-old-bse.html
full text ;
http://creutzfeldt-jakob-disease.blogspot.com/2009/04/unusually-presenting-case-of-scjdthe.html
Tuesday, July 14, 2009
U.S. Emergency Bovine Spongiform Encephalopathy Response Plan Summary and BSE Red Book Date: February 14, 2000 at 8:56 am PST
WHERE did we go wrong $$$
http://madcowtesting.blogspot.com/2009/07/us-emergency-bovine-spongiform.html
Monday, June 01, 2009 Biochemical typing of pathological prion protein in aging cattle with BSE
SOMETHING TO PONDER ???
O.K. confusious asks, IF all these new atypical BSEs i.e. new strains of mad cow disease is just an 'OLD COW PRION DISEASE', why then can not the 'old human prion disease' such as the sporadic CJD, be from an 'old cow prion disease', same as the nvCJD 'young people mad cow disease' (which also happens in 74 year old), but why cannot the 'old cow prion diseases', i.e. l-BSE, h-BSE, and ibncBSE, cause the 'old people prion disease', which looks like sporadic CJD. seems that is what some of the pathology is showing ???
OH, that probably makes too much sense, and that the only answer could be that it's all just a happenstance of bad luck and or a spontaneous event, that just happens out of the clear blue sky $$$
IF this is the case, then where are all the SPONTANEOUS BSE CASES OF MAD COW DISEASE IN THE U.S.A., AND WHERE HAVE THEY BEEN BURIED IN THE USA OVER THE LAST 25 YEARS ???
http://bse-atypical.blogspot.com/2009/06/biochemical-typing-of-pathological.html
NOW, in 2009, in the USA, these fools want us to believe it's all nothing more than a Spontaneous Generation of Prion Infectivity, and or a familial hereditary mad cow strain in the USA that is BY SOME MIRACLE, not related to feed ;
H- and L-type BSE, collectively known as atypical BSE, differ from classical BSE by displaying a different disease phenotype and they have not been linked to the consumption of contaminated feed. Interestingly, the 2006 U.S. H-type atypical BSE animal had a polymorphism at codon 211 of the bovine prion gene resulting in a glutamic acid to lysine substitution (E211K).
https://ars.usda.gov/research/publications/publications.htm?SEQ_NO_115=226214
SO, by this i gather they have done transmission studies on atypical h type and l type BSE and neither can be transmitted by the oral route ???
or is this just more of the same old BSe, they don't know, but they conclude this with a crystal ball of some sort $$$
I remember this study well, and it was suppose to conclude this year 2009. However, when i ask and ask about this study, it becomes a top secret, everybody has closed lips and will not talk ;
----- Original Message -----
From: Justin Greenlee
To: Terry S. Singeltary Sr.
Sent: Friday, July 31, 2009 3:17 PM
Subject: Re: re-Research Project: Study of Atypical Bse
Sorry for the slow reply- your email got filtered by the FED spam system and I only recently checked for docked messages.
There are no transmission studies that are specifically associated with this project being conducted at the NADC. Probably the easiest way to learn a little bit more about what we’re doing is to give me a call sometime.
Justin
Justin J. Greenlee, DVM, PhD, Diplomate ACVP Virus and Prion Diseases of Livestock Research Unit National Animal Disease Center, USDA, ARS 2300 Dayton Ave, PO BOX 70 Ames, IA 50010
phone (515) 663-7191 FAX (515) 663-7458
On 6/15/09 4:30 PM, "Terry S. Singeltary Sr." <flounder9@verizon.net> wrote:
re-Research Project: Study of Atypical Bse
http://www.ars.usda.gov/research/projects/projects.htm?ACCN_NO=408490
Greetings Sir,
I have been most interested in these transmission studies, and i know it is probably to early for you to say much about them. but, could you please give me an update of some kind, as to if transmission of any type occured, with any tissues and or body fluids. i suppose i am a bit anxious about these studies. ...
many thanks for your work,
kindest regards, terry
----- Original Message -----
From: Terry S. Singeltary Sr.
To: maria.caramelli@izsto.it
Sent: Friday, July 31, 2009 6:07 PM
Subject: re-Research Project: Study of Atypical Bse
Team Leader: Dr. Maria Caramelli Via Bologna 148 Torino, I- 10154, Italy Contact: Dr. Maria Caramelli Tel: +39 11 2686296 Fax: +39 11 2686360 E-mail: maria.caramelli@izsto.it Institute website: http://www.izsto.it
Hello Dr. Maria Caramelli,
A kind and warm greetings from Bacliff, Texas!
I hope you do not mind, but I thought I might write and ask you a bit on some transmission studies taking place, and any results there from. I have been most interested in human and animal TSE as a lay person, since the death of my mother to the Heidenhain Variant of Creutzfeldt Jakob Disease. The study in question is as follows ;
re-Research Project: Study of Atypical Bse
http://www.ars.usda.gov/research/projects/projects.htm?ACCN_NO=408490
_any_ help would be most appreciative ! and, if confidentiality is a problem, my lips are sealed !
many thanks for your continued work on TSEs. ...
Thank You,
with warmest regards,
I am sincerely,
Terry S. Singeltary Sr. P.O. Box 42 Bacliff, Texas USA 77518
THIS study specifically stated ;
> 3. Studies on transmissibility and tissue distribution of atypical BSE isolates in cattle and other species.
Research Project: Study of Atypical Bse Location: Virus and Prion Diseases of Livestock
Project Number: 3625-32000-086-05 Project Type: Specific Cooperative Agreement
Start Date: Sep 15, 2004 End Date: Sep 14, 2009
Objective: The objective of this cooperative research project with Dr. Maria Caramelli from the Italian BSE Reference Laboratory in Turin, Italy, is to conduct comparative studies with the U.S. bovine spongiform encephalopathy (BSE) isolate and the atypical BSE isolates identified in Italy. The studies will cover the following areas: 1. Evaluation of present diagnostics tools used in the U.S. for the detection of atypical BSE cases. 2. Molecular comparison of the U.S. BSE isolate and other typical BSE isolates with atypical BSE cases. 3. Studies on transmissibility and tissue distribution of atypical BSE isolates in cattle and other species.
Approach: This project will be done as a Specific Cooperative Agreement with the Italian BSE Reference Laboratory, Istituto Zooprofilattico Sperimentale del Piemonte, in Turin, Italy. It is essential for the U.S. BSE surveillance program to analyze the effectiveness of the U.S diagnostic tools for detection of atypical cases of BSE. Molecular comparisons of the U.S. BSE isolate with atypical BSE isolates will provide further characterization of the U.S. BSE isolate. Transmission studies are already underway using brain homogenates from atypical BSE cases into mice, cattle and sheep. It will be critical to see whether the atypical BSE isolates behave similarly to typical BSE isolates in terms of transmissibility and disease pathogenesis. If transmission occurs, tissue distribution comparisons will be made between cattle infected with the atypical BSE isolate and the U.S. BSE isolate. Differences in tissue distribution could require new regulations regarding specific risk material (SRM) removal.
http://www.ars.usda.gov/research/projects/projects.htm?ACCN_NO=408490
Amazing is it not, the USA have cattle that cannot get BSE or any other TSE by eating tainted mad cow type feed, only a sub-type of TSE that is NOT transmissible by feed of any sorts, NOT transmissible to humans in any way, and one that cannot be seen since 2006. what a wonderful place we live that these miracles can take place $$$ OH yes, i must not forget, Santa will be coming soon. ...TSS
PRODUCT Bulk Whole Barley, Recall # V-256-2009
CODE No code or lot number.
RECALLING FIRM/MANUFACTURER Mars Petcare US, Clinton, OK, by telephone on May 21, 2009. Firm initiated recall is complete.
REASON Product may have contained prohibited materials without cautionary statement on the label.
VOLUME OF PRODUCT IN COMMERCE 208,820 pounds
DISTRIBUTION TX END OF ENFORCEMENT REPORT FOR AUGUST 26, 2009
###
http://www.fda.gov/Safety/Recalls/EnforcementReports/ucm180348.htm
Greetings,
I saw this latest mad cow feed warning letter and notice a few changes. thought it looked a little fishy, so looking further i find it seems that now the FDA et al could not say mad cow or BSE, even if they had a mouth full of it, this is exactly what this warning letter recall is about, recalling potential mad cow feed, that might contain prions, that might get fed to cattle or other ruminants. this is the poorest i have seen yet on a warning letter with lack of information. compare it to the feed ban recall warning letter at the bottom. ALSO, This violator violations were so bad, they required an OAI on 05/28/2009, but you would not have noticed this by it's warning letter. SO, you have 208,820 pounds more of suspect mad cow feed IN COMMERCE, feeding to pets, or maybe cattle, who knows, no warning label on it. NOTHING HAS CHANGED, IT'S ALL STILL VOLUNTARY BSe. ...
I reported this back on Saturday, June 13, 2009 ;
DAL-DO 3007064862 Mars Petcare US #1 Mars Road Clinton OK 73601 OPR PF HP 05/28/2009 OAI Y
snip...
An OAI inspection classification occurs when significant objectionable conditions or practices were found and regulatory sanctions are warranted in order to address the establishment's lack of compliance with the regulation. An example of an OAI inspection classification would be findings of manufacturing procedures insufficient to ensure that ruminant feed is not contaminated with prohibited material. Inspections classified with OAI violations will be promptly re-inspected following the regulatory sanctions to determine whether adequate corrective actions have been implemented
snip...
http://madcowfeed.blogspot.com/2009/06/bse-feed-violations-usa-update-from.html
I SUPPOSE, IF ONE WAITS LONG ENOUGH BEFORE ANNOUNCING RECALL, ONE MIGHT HOPE ALL MAD COW FEED IS FED OUT INTO COMMERCE $$$
#70
GUIDANCE FOR INDUSTRY
SMALL ENTITIES COMPLIANCE GUIDE FOR FEEDERS OF RUMINANT ANIMALS WITHOUT ON-FARM FEED MIXING OPERATIONS
(This version of the guidance replaces the version that was made available in February 1998. This guidance document has been revised to update contact information and provide new requirements regarding the use of tallow in ruminant feed.)
Submit comments on this guidance at any time. Submit written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852. Comments may also be submitted electronically on the Internet at http://www.regulations.gov.
For questions regarding this guidance document, contact Shannon Jordre, Division of Compliance (HFV-230), U.S. Food and Drug Administration, Center for Veterinary Medicine, 7519 Standish Place, MPN-4, Rockville, MD 20855, (240) 276-9229.
Additional copies of this guidance document may be requested from the Communications Staff, HFV-12, Center for Veterinary Medicine, U.S. Food and Drug Administration, 7519 Standish Place, Rockville, MD 20855, and may be viewed on the Internet at
http://www.fda.gov/AnimalVeterinary/default.htm.
U.S. Department of Health and Human Services Food and Drug Administration Center for Veterinary Medicine July 13, 2009
CONTAINS NON-BINDING RECOMMENDATIONS
Guidance for Industry
SMALL ENTITIES COMPLIANCE GUIDE FOR FEEDERS OF RUMINANT ANIMALS WITHOUT ON-FARM FEED MIXING OPERATIONS1
This guidance document represents the Food and Drug Administration’s (FDA’s) current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. You can use an alterative approach if the approach satisfies the requirements of the applicable statutes and regulations. If you want to discuss an alternative approach, contact the FDA staff responsible for implementing this guidance. If you cannot identify the appropriate FDA staff, call the appropriate number listed on the title page of this guidance.
Introduction
On April 25, 2008, FDA published a final rule in the Federal Register, entitled “Substances Prohibited from Use in Animal Food or Feed” (73 FR 22719). See also 73 FR 18626; April 24, 2009. This final rule established a new regulation at 21 CFR 589.2001 entitled, “Cattle Materials Prohibited in Animal Food or Feed to Prevent the Transmission of Bovine Spongiform Encephalopathy”. 21 CFR 589.2001 prohibits the use of certain cattle materials in the feed of all animals and is aimed primarily at rendering operations. This new rule also amended the previously existing BSE regulation, 21 CFR 589.2000 entitled, “Animal Proteins Prohibited in Ruminant Feed“, which addresses only the feeding of ruminant animals.
The Food and Drug Administration (FDA) has prepared this Small Entities Compliance Guide in accordance with section 212 of the Small Business Regulatory Enforcement Fairness Act of 1996. (Public Law 104-121). This guidance document represents the agency's current thinking on compliance with the regulation 21 CFR 589.2000 "Animal Proteins Prohibited in Ruminant Feed", as amended during the recent rule-making process, and how the regulation impacts livestock producers feeding ruminant animals.
FDA’s guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word “should” in Agency guidances means that something is suggested or recommended, but not required.
What Is The Purpose And Scope Of This Regulation, 21 CFR 589.2000?
This regulation is designed to prevent the establishment and amplification of Bovine Spongiform Encephalopathy (BSE), sometimes referred to as “Mad Cow Disease,” through animal feed. The
1 This guidance has been prepared by the Office of Surveillance and Compliance in the Center for Veterinary Medicine.
2
CONTAINS NON-BINDING RECOMMENDATIONS
regulation prohibits the use of certain proteins derived from mammalian tissue in feeding ruminant animals. An example is meat and bone meal derived from cattle. However, certain products are exempt from this regulation.
• The following protein products derived from mammals are exempt:
• Blood and blood products
• Gelatin
• Milk products (milk and milk proteins)
• Pure porcine (pork) or pure equine (horse) protein products
• Inspected meat products, such as plate waste, which have been cooked and offered for human food and further heat processed for animal feed
• The following nonmammalian protein products are exempt:
• Poultry
• Marine (fish)
• Vegetable
• The following products are also exempt because they are not protein or tissue:
• Grease
• Tallow that contains no more than 0.15% insoluble impurities2
• Fat3
• Amino acids
• Vegetable oil
• Dicalcium phosphate
We refer to the exempted products throughout this guide as “nonprohibited material.” We refer to all mammalian protein that is not exempted as “prohibited material.”
Prohibited material and/or feeds containing prohibited material cannot be fed to ruminant animals. “Ruminant animals” are any animals with a four-chambered stomach including cattle, sheep, goats, buffalo, elk, and deer.
Is My Operation Affected By 21 CFR 589.2000?
• This regulation applies to livestock feeding operations that feed ruminants. The regulation applies to "establishments and individuals that are responsible for feeding ruminants" to make it clear that all responsible persons, in both large and small feeding operations, are subject to the regulation.
• Examples include dairies, cattle feed lots, calf and lamb raising operations, cattle, sheep, and goat grazing operations.
2 Tallow is defined by 21 CFR 589.2001(b)(5) as the rendered fat of cattle. Tallow that contains more that 0.15% insoluble impurities is considered to be an animal protein prohibited in ruminant feed in 21 CFR 589.2000(a)(1). Such tallow should be labeled with the cautionary statement “Do Not Feed to Cattle or Other Ruminants.”
3 Excludes tallow that contains more than 0.15% insoluble impurities.
3
CONTAINS NON-BINDING RECOMMENDATIONS
• If a feed product intended for ruminants contains animal protein, the protein can consist only of nonprohibited material.
• The Association of American Feed Control Officials (AAFCO) has identified the following ingredients listed in its Official Publication as prohibited material:
• Meat
• Meat By-Products
• Animal Liver
• Dried Meat Solubles
• Fleshings Hydrolysate
• Meat Meal
• Meat and Bone Meal
• Animal By-Product Meal
• Meat Meal Tankage
• Meat and Bone Meal Tankage
• Hydrolyzed Leather Meal
• Hydrolyzed Hair
• Glandular Meal and Extracted Glandular Meal
• Stock/Broth
• Animal Digest
• Cooked Bone Marrow
• Leather Hydrolysate
• Meat Protein Isolate
• Mechanically Separated Bone Marrow
• Unborn Calf Carcasses
• Bone Meal, cooked
• Bone Meal, steamed
• Dehydrated Garbage
• Dehydrated Food-Waste
• Salvage Pet Food
• Distressed Pet Food
Feed and feed ingredients not containing animal proteins are not subject to the regulation.
• Persons who feed prohibited material to ruminants would be subject to regulatory action under the Federal Food, Drug, and Cosmetic Act. Regulatory action could include seizure of inventory, injunction against feeding prohibited material to ruminants, or prosecution.
Note: If you mix your own feed for your ruminant animals, you are subject to additional requirements. Consult the “Small Entities Compliance Guide for Feeders of Ruminant Animals with On-Farm Feed Mixing Operations,” FDA Guidance for Industry 69.
How Do I Comply With 21 CFR 589.2000?
4
CONTAINS NON-BINDING RECOMMENDATIONS
1. Do not feed products labeled with the caution statement “Do not feed to cattle or other ruminants” to your ruminant animals4.
2. Maintain copies of all purchase invoices for ALL feeds received that contain animal protein.
3. Maintain copies of labeling for ALL feeds received containing animal protein products.
4. Keep invoices and labeling available for inspection and copying.
5. Maintain the records for a minimum of one year.
What Other Information Do I Need To Know To Help Me Comply With 21 CFR 589.2000?
• Renderers, protein blenders, and feed manufacturers are required to label products containing prohibited materials with the cautionary statement Do not feed to cattle or other ruminants.
• If you intend to feed only ruminant animals, products with this caution statement should not be available for use in your operation. If the feed does not bear the caution statement but you suspect that it contains prohibited material, do not use it until you are sure that it does not contain such materials.
• If you intend to use a feed containing prohibited material for nonruminant animals, take steps to ensure that the feed will not be fed to ruminants.
• Labeling And Record Keeping
• For bulk shipments it is common practice to provide labeling information on the invoice. In such cases, retaining the invoice is sufficient documentation.
• If the only labeling for a bulk product is on a placard, the placard for each shipment should be retained.
• Feed may also be received in bags or other containers that have attached labeling. In those instances, the labeling should be removed and retained. However, maintenance of only one such labeling piece from each shipment that represents a different product is necessary.
• If the labeling cannot be removed from the bag or other container, it is acceptable to retain a representative bag or a transposed copy of the labeling information from a container that cannot feasibly be stored.
• The records should be legible and readily retrievable.
4 If the product label bears the “Do Not Feed to Animals” statement, take steps to ensure that it is not fed to animals. This product should not have been introduced into the animal feed chain because it is prohibited from use in any animal feed by another rule titled “SUBSTANCES PROHIBITED FROM USE IN ANIMAL FOOD OR FEED” and codified in 21 CFR 589.2001. This rule published on April 25, 2008, with an effective date of April 27, 2009.
5
CONTAINS NON-BINDING RECOMMENDATIONS
• The one year requirement for maintenance of records means one year from the date of the receipt of the product.
• Inspections
• On-farm inspections will be limited but will be needed on a selective basis to trace prohibited material to verify that it is not being shipped to ruminant producers and fed to ruminant animals. For example, on-farm inspection might be necessary as a follow up to a feed mill inspection, to verify that feed not labeled with the cautionary statement is in fact being fed to nonruminant animals.
http://www.fda.gov/downloads/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/UCM052385.pdf
FDA GUIDANCE FOR INDUSTRY 67 This guide replaces those parts of Guidance for Industry 60, June 17, 1997, that applied to renderers.
http://www.fda.gov/downloads/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/ucm052381.pdf
FDA GUIDANCE FOR INDUSTRY 68 This guide replaces those parts of Guidance for Industry 60, June 17, 1997, that applied to protein blenders, feed manufacturers, and distributors. SMALL ENTITIES COMPLIANCE GUIDE FOR PROTEIN BLENDERS, FEED MANUFACTURERS, AND DISTRIBUTORS This document is intended to provide guidance for “ANIMAL PROTEINS PROHIBITED FROM USE IN RUMINANT FEED,” Title 21, Code of Federal Regulations, Part 589.2000, Effective Date: August 4, 1997.
http://www.fda.gov/downloads/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/ucm052382.pdf
NOTHING BUT INK ON PAPER I TELL YOU !
10,000,000+ LBS. of PROHIBITED BANNED MAD COW FEED I.E. BLOOD LACED MBM IN COMMERCE USA 2007
Date: March 21, 2007 at 2:27 pm PST
RECALLS AND FIELD CORRECTIONS: VETERINARY MEDICINES -- CLASS II
___________________________________
PRODUCT
Bulk cattle feed made with recalled Darling's 85% Blood Meal, Flash Dried, Recall # V-024-2007
CODE
Cattle feed delivered between 01/12/2007 and 01/26/2007
RECALLING FIRM/MANUFACTURER
Pfeiffer, Arno, Inc, Greenbush, WI. by conversation on February 5, 2007.
Firm initiated recall is ongoing.
REASON
Blood meal used to make cattle feed was recalled because it was cross- contaminated with prohibited bovine meat and bone meal that had been manufactured on common equipment and labeling did not bear cautionary BSE statement.
VOLUME OF PRODUCT IN COMMERCE
42,090 lbs.
DISTRIBUTION
WI
___________________________________
PRODUCT
Custom dairy premix products: MNM ALL PURPOSE Pellet, HILLSIDE/CDL Prot- Buffer Meal, LEE, M.-CLOSE UP PX Pellet, HIGH DESERT/ GHC LACT Meal, TATARKA, M CUST PROT Meal, SUNRIDGE/CDL PROTEIN Blend, LOURENZO, K PVM DAIRY Meal, DOUBLE B DAIRY/GHC LAC Mineral, WEST PIONT/GHC CLOSEUP Mineral, WEST POINT/GHC LACT Meal, JENKS, J/COMPASS PROTEIN Meal, COPPINI - 8# SPECIAL DAIRY Mix, GULICK, L-LACT Meal (Bulk), TRIPLE J - PROTEIN/LACTATION, ROCK CREEK/GHC MILK Mineral, BETTENCOURT/GHC S.SIDE MK-MN, BETTENCOURT #1/GHC MILK MINR, V&C DAIRY/GHC LACT Meal, VEENSTRA, F/GHC LACT Meal, SMUTNY, A- BYPASS ML W/SMARTA, Recall # V-025-2007
CODE
The firm does not utilize a code - only shipping documentation with commodity and weights identified.
RECALLING FIRM/MANUFACTURER
Rangen, Inc, Buhl, ID, by letters on February 13 and 14, 2007. Firm initiated recall is complete.
REASON
Products manufactured from bulk feed containing blood meal that was cross contaminated with prohibited meat and bone meal and the labeling did not bear cautionary BSE statement.
VOLUME OF PRODUCT IN COMMERCE
9,997,976 lbs.
DISTRIBUTION
ID and NV
END OF ENFORCEMENT REPORT FOR MARCH 21, 2007
http://www.fda.gov/bbs/topics/enforce/2007/ENF00996.html
NEW URL
http://www.fda.gov/Safety/Recalls/EnforcementReports/2007/ucm120446.htm
Thursday, March 19, 2009 MILLIONS AND MILLIONS OF POUNDS OF MAD COW FEED IN COMMERCE USA WITH ONGOING 12 YEARS OF DENIAL NOW, WHY IN THE WORLD DO WE TO TALK ABOUT THIS ANYMORE $$$
http://madcowfeed.blogspot.com/2009/03/millions-and-millions-of-pounds-of-mad.html
Monday, August 17, 2009 FDA asked to ban poultry litter from feed AGAIN 17 Aug 2009 Ban that Poop!
http://madcowfeed.blogspot.com/2009/08/fda-asked-to-ban-poultry-litter-from.html
Saturday, June 13, 2009
Monitoring the occurrence of emerging forms of Creutzfeldt-Jakob disease in the United States 2003 revisited 2009
http://cjdusa.blogspot.com/2009/06/monitoring-occurrence-of-emerging-forms.html
SEE THE VIDEO NOW AT THE BOTTOM OF THE BLOG BELOW ;
http://creutzfeldt-jakob-disease.blogspot.com/2009/07/usa-hiding-mad-cow-disease-victims-as.html
Tuesday, August 18, 2009
BSE-The Untold Story - joe gibbs and singeltary 1999 - 2009
http://madcowusda.blogspot.com/2009/08/bse-untold-story-joe-gibbs-and.html
Sunday, August 09, 2009
CJD...Straight talk with...James Ironside...and...Terry Singeltary... 2009
http://creutzfeldt-jakob-disease.blogspot.com/2009/08/cjdstraight-talk-withjames.html
Thursday, July 10, 2008
A New Prionopathy update July 10, 2008
snip...
DOES ANYONE BESIDES ME SEE A PATTERN YET ???
Vickey Rimmer, 16, DID NOT DIE FROM nvCJD, she died from a form of sporadic CJD, whatever the hell that is. and there have been 16 year old die from sporadic CJD in the USA as well.
SIMPLY PUT, the ukbsenvcjd only theory was wrong from day one. the elderly are expendable, pets and kids are not.
Science was dictated by 'big buisness' after the Vickey Rimmer case with the ukbsenvcjd only myth.
snip...
Sporadic creutzfeldt-jakob disease in two adolescents
http://jnnp.bmj.com/cgi/content/abstract/jnnp.2006.104570v1
see full text sporadic CJD the big lie;
snip...
IT seems we have come full circle from the 'ORIGINAL 10' i.e. the 1st 10 adolescents in the UKBSEnvCJD only theory. and now we find us at the 1st 10 in USA, or is it the first 10, or the tip of the iceburg, many that went undocumented ???
lets look at the full circle, to date ;
http://cjdmadcowbaseoct2007.blogspot.com/2008/07/new-prionopathy-update-july-10-2008.html
Sunday, August 10, 2008 A New Prionopathy OR more of the same old BSe and sporadic CJD
http://creutzfeldt-jakob-disease.blogspot.com/2008/08/new-prionopathy-or-more-of-same-old-bse.html
full text ;
http://creutzfeldt-jakob-disease.blogspot.com/2009/04/unusually-presenting-case-of-scjdthe.html
Tuesday, July 14, 2009
U.S. Emergency Bovine Spongiform Encephalopathy Response Plan Summary and BSE Red Book Date: February 14, 2000 at 8:56 am PST
WHERE did we go wrong $$$
http://madcowtesting.blogspot.com/2009/07/us-emergency-bovine-spongiform.html
Monday, June 01, 2009 Biochemical typing of pathological prion protein in aging cattle with BSE
SOMETHING TO PONDER ???
O.K. confusious asks, IF all these new atypical BSEs i.e. new strains of mad cow disease is just an 'OLD COW PRION DISEASE', why then can not the 'old human prion disease' such as the sporadic CJD, be from an 'old cow prion disease', same as the nvCJD 'young people mad cow disease' (which also happens in 74 year old), but why cannot the 'old cow prion diseases', i.e. l-BSE, h-BSE, and ibncBSE, cause the 'old people prion disease', which looks like sporadic CJD. seems that is what some of the pathology is showing ???
OH, that probably makes too much sense, and that the only answer could be that it's all just a happenstance of bad luck and or a spontaneous event, that just happens out of the clear blue sky $$$
IF this is the case, then where are all the SPONTANEOUS BSE CASES OF MAD COW DISEASE IN THE U.S.A., AND WHERE HAVE THEY BEEN BURIED IN THE USA OVER THE LAST 25 YEARS ???
http://bse-atypical.blogspot.com/2009/06/biochemical-typing-of-pathological.html
NOW, in 2009, in the USA, these fools want us to believe it's all nothing more than a Spontaneous Generation of Prion Infectivity, and or a familial hereditary mad cow strain in the USA that is BY SOME MIRACLE, not related to feed ;
H- and L-type BSE, collectively known as atypical BSE, differ from classical BSE by displaying a different disease phenotype and they have not been linked to the consumption of contaminated feed. Interestingly, the 2006 U.S. H-type atypical BSE animal had a polymorphism at codon 211 of the bovine prion gene resulting in a glutamic acid to lysine substitution (E211K).
https://ars.usda.gov/research/publications/publications.htm?SEQ_NO_115=226214
SO, by this i gather they have done transmission studies on atypical h type and l type BSE and neither can be transmitted by the oral route ???
or is this just more of the same old BSe, they don't know, but they conclude this with a crystal ball of some sort $$$
I remember this study well, and it was suppose to conclude this year 2009. However, when i ask and ask about this study, it becomes a top secret, everybody has closed lips and will not talk ;
----- Original Message -----
From: Justin Greenlee
To: Terry S. Singeltary Sr.
Sent: Friday, July 31, 2009 3:17 PM
Subject: Re: re-Research Project: Study of Atypical Bse
Sorry for the slow reply- your email got filtered by the FED spam system and I only recently checked for docked messages.
There are no transmission studies that are specifically associated with this project being conducted at the NADC. Probably the easiest way to learn a little bit more about what we’re doing is to give me a call sometime.
Justin
Justin J. Greenlee, DVM, PhD, Diplomate ACVP Virus and Prion Diseases of Livestock Research Unit National Animal Disease Center, USDA, ARS 2300 Dayton Ave, PO BOX 70 Ames, IA 50010
phone (515) 663-7191 FAX (515) 663-7458
On 6/15/09 4:30 PM, "Terry S. Singeltary Sr." <flounder9@verizon.net> wrote:
re-Research Project: Study of Atypical Bse
http://www.ars.usda.gov/research/projects/projects.htm?ACCN_NO=408490
Greetings Sir,
I have been most interested in these transmission studies, and i know it is probably to early for you to say much about them. but, could you please give me an update of some kind, as to if transmission of any type occured, with any tissues and or body fluids. i suppose i am a bit anxious about these studies. ...
many thanks for your work,
kindest regards, terry
----- Original Message -----
From: Terry S. Singeltary Sr.
To: maria.caramelli@izsto.it
Sent: Friday, July 31, 2009 6:07 PM
Subject: re-Research Project: Study of Atypical Bse
Team Leader: Dr. Maria Caramelli Via Bologna 148 Torino, I- 10154, Italy Contact: Dr. Maria Caramelli Tel: +39 11 2686296 Fax: +39 11 2686360 E-mail: maria.caramelli@izsto.it Institute website: http://www.izsto.it
Hello Dr. Maria Caramelli,
A kind and warm greetings from Bacliff, Texas!
I hope you do not mind, but I thought I might write and ask you a bit on some transmission studies taking place, and any results there from. I have been most interested in human and animal TSE as a lay person, since the death of my mother to the Heidenhain Variant of Creutzfeldt Jakob Disease. The study in question is as follows ;
re-Research Project: Study of Atypical Bse
http://www.ars.usda.gov/research/projects/projects.htm?ACCN_NO=408490
_any_ help would be most appreciative ! and, if confidentiality is a problem, my lips are sealed !
many thanks for your continued work on TSEs. ...
Thank You,
with warmest regards,
I am sincerely,
Terry S. Singeltary Sr. P.O. Box 42 Bacliff, Texas USA 77518
THIS study specifically stated ;
> 3. Studies on transmissibility and tissue distribution of atypical BSE isolates in cattle and other species.
Research Project: Study of Atypical Bse Location: Virus and Prion Diseases of Livestock
Project Number: 3625-32000-086-05 Project Type: Specific Cooperative Agreement
Start Date: Sep 15, 2004 End Date: Sep 14, 2009
Objective: The objective of this cooperative research project with Dr. Maria Caramelli from the Italian BSE Reference Laboratory in Turin, Italy, is to conduct comparative studies with the U.S. bovine spongiform encephalopathy (BSE) isolate and the atypical BSE isolates identified in Italy. The studies will cover the following areas: 1. Evaluation of present diagnostics tools used in the U.S. for the detection of atypical BSE cases. 2. Molecular comparison of the U.S. BSE isolate and other typical BSE isolates with atypical BSE cases. 3. Studies on transmissibility and tissue distribution of atypical BSE isolates in cattle and other species.
Approach: This project will be done as a Specific Cooperative Agreement with the Italian BSE Reference Laboratory, Istituto Zooprofilattico Sperimentale del Piemonte, in Turin, Italy. It is essential for the U.S. BSE surveillance program to analyze the effectiveness of the U.S diagnostic tools for detection of atypical cases of BSE. Molecular comparisons of the U.S. BSE isolate with atypical BSE isolates will provide further characterization of the U.S. BSE isolate. Transmission studies are already underway using brain homogenates from atypical BSE cases into mice, cattle and sheep. It will be critical to see whether the atypical BSE isolates behave similarly to typical BSE isolates in terms of transmissibility and disease pathogenesis. If transmission occurs, tissue distribution comparisons will be made between cattle infected with the atypical BSE isolate and the U.S. BSE isolate. Differences in tissue distribution could require new regulations regarding specific risk material (SRM) removal.
http://www.ars.usda.gov/research/projects/projects.htm?ACCN_NO=408490
Amazing is it not, the USA have cattle that cannot get BSE or any other TSE by eating tainted mad cow type feed, only a sub-type of TSE that is NOT transmissible by feed of any sorts, NOT transmissible to humans in any way, and one that cannot be seen since 2006. what a wonderful place we live that these miracles can take place $$$ OH yes, i must not forget, Santa will be coming soon. ...TSS
Monday, August 17, 2009
FDA asked to ban poultry litter from feed AGAIN 17 Aug 2009
Ban that Poop!
Would you feed animal waste to your dog or cat? Probably not. It’s dirty, disgusting and clearly unsafe. Unfortunately, not all animals are so lucky. In areas of the United States where large cattle and poultry operations coexist, poultry litter is routinely fed to cows. Poultry litter consists primarily of manure, feathers, spilled feed and bedding material that accumulate on the floors of the buildings that house chickens and turkeys. It can contain disease-causing bacteria, antibiotics, toxic heavy metals, feed ingredients normally prohibited for cattle, and even foreign objects such as dead rodents, rocks, nails and glass. Surprisingly, this unhealthy and inhumane practice is legal. We need your help to convince the government to ban litter feeding NOW.
http://www.foodanimalconcerns.org/humane4.htm
UNITED STATES DEPARTMENT OF HEALTH AND HUMAN SERVICES FOOD AND DRUG ADMINISTRATION Petition to Declare Poultry Litter) as a Food Additive and to) Ban Its Use as Cattle Feed) Docket No. ______________ submitted by FOOD ANIMAL CONCERNS TRUST August 12, 2009 Richard Wood Executive Director PO Box 14599 Chicago, IL 60614 Phone: (773) 525-4952
http://www.foodanimalconcerns.org/PDF/FDA%20Chicken%20Litter%20Petition_final.pdf
FILTHY FEED REPORT
http://www.foodanimalconcerns.org/PDF/FDA%20Chicken%20Litter%20Petition_final.pdf
For Release: Immediate Contact: Jacki Rossi, (773) 525-4952August 13, 2009 mhtml:%7B33B38F65-8D2E-434D-8F9B-8BDCD77D3066%7Dmid://00000069/!x-usc:mailto:jrossi@foodanimalconcerns.orgFACT Petitions FDA to Ban Poultry Litter as Cattle Feed New campaign launches to end dangerous agricultural practice
http://www.foodanimalconcerns.org/PDF/filthyfeed_release_FINAL.pdf
FDA asked to ban poultry litter from feed 17 Aug 2009
A consumer advocacy group Food Animal Concern Trust (FACT) is urging the Food and Drug Administration (FDA) to ban the use of poultry litter in cattle feed through a petition on its website.
The FDA considered such a ban after the nation’s first case of mad cow disease surfaced in 2003 but never took the action, reports state. On the Food Animal Concern Trust (FACT) website, it states:
"Would you feed animal waste to your dog or cat? Probably not. It's dirty, disgusting and intuitively just seems wrong. Unfortunately, not all animals are so lucky. In areas of the United States where large cattle and poultry operations coexist, chicken waste (or, more accurately, 'poultry litter') is routinely fed to cows. Poultry litter consists primarily of manure, feathers, spilled feed and bedding material that accumulate on the floors of the buildings that chickens and turkeys. It can contain disease-causing bacteria, antibiotics, toxic heavy metals, substances that cause Mad Cow Disease, and even foreign objects such as dead rodents, rocks, nails and glass. Surprisingly, this unhealthy and inhumane practice is legal and poorly monitored - creating unacceptable risks to human and animal health. The FDA needs to ban the use of animal waste as animal feed before human and animal health is further compromised".
The website goes on to say that many prominent groups have endorsed its efforts to elicit an FDA ban on feeding poultry litter to cattle. These groups include the Center for Food Safety, the Center for Science in the Public Interest, Consumer Federation of America, Consumers Union, Food & Water Watch, Humane Society of the United States, Institute for Agriculture and Trade Policy, National Sustainable Agriculture Coalition, etc.
http://www.allaboutfeed.net/news/fda-asked-to-ban-poultry-litter-from-feed-3487.html
and don't think birds cannot get mad cow disease, what about BIG BIRD I.E. RED TAIL OSTRICH ;-)
DAMN, i cannot find the original paper.........i have the report somewhere here ???
A contribution to the neuropathology of the red-necked ostrich (struthio camelus) - spongiform encephalopathy
spongiform encephlopathy in the red-necked ostrich (struthio camelus). A case history
YES !
A CONTRIBUTION TO THE NEUROPATHOLOGY OF THE RED-NECKED OSTRICH (STRUTHIO CAMELUS) - SPONGIFORM ENCEPHALOPATHY
http://www.bseinquiry.gov.uk/files/sc/Seac10/tab06.pdf
re--FDA asked to ban poultry litter from feed 17 Aug 2009
POMISES, POMISES, PROMISES...........not......LIES, LIES, AND MORE LIES $$$
*** DO NOT forget what was originally promised years ago !!!
Press Release FOR IMMEDIATE RELEASE Monday, Jan. 26, 2004 FDA Press Office 301-827-6242
Expanded "Mad Cow" Safeguards Announced to Strengthen Existing Firewalls Against BSE Transmission HHS Secretary Tommy G. Thompson today announced several new public health measures, to be implemented by the Food and Drug Administration (FDA), to strengthen significantly the multiple existing firewalls that protect Americans from exposure to the agent thought to cause bovine spongiform encephalopathy (BSE, also known as mad cow disease) and that help prevent the spread of BSE in U.S. cattle.
The existing multiple firewalls, developed by both the U.S. Department of Agriculture (USDA) and HHS, have been extremely effective in protecting the American consumer from exposure to BSE. The first firewall is based on import controls started in 1989. A second firewall is surveillance of the U.S. cattle population for the presence of BSE, a USDA firewall that led to the finding of the BSE cow in December. The third firewall is FDA's 1997 animal feed ban, which is the critical safeguard to help prevent the spread of BSE through cattle herds by prohibiting the feeding of most mammalian protein to ruminant animals, including cattle. The fourth firewall, recently announced by USDA, makes sure that no bovine tissues known to be at high risk for carrying the agent of BSE enter the human food supply regulated by USDA. The fifth firewall is effective response planning to contain the potential for any damage from a BSE positive animal, if one is discovered. This contingency response plan, which had been developed over the past several years, was initiated immediately upon the discovery of a BSE positive cow in Washington State December 23.
The new safeguards being announced today are science-based and further bolster these already effective safeguards.
Specifically, HHS intends to ban from human food (including dietary supplements), and cosmetics a wide range of bovine-derived material so that the same safeguards that protect Americans from exposure to the agent of BSE through meat products regulated by USDA also apply to food products that FDA regulates.
FDA will also prohibit certain currently allowed feeding and manufacturing practices involving feed for cattle and other ruminant animals. These additional measures will further strengthen FDA's 1997 "animal feed" rule.
"Today's actions will make strong public health protections against BSE even stronger," Secretary Thompson said. "Although the current animal feed rule provides a strong barrier against the further spread of BSE, we must never be satisfied with the status quo where the health and safety of our animals and our population is at stake. The science and our own experience and knowledge in this area are constantly evolving. Small as the risk may already be, this is the time to make sure the public is protected to the greatest extent possible."
"Today we are bolstering our BSE firewalls to protect the public," said FDA Commissioner Mark B. McClellan, M.D., Ph.D. "We are further strengthening our animal feed rule, and we are taking additional steps to further protect the public from being exposed to any potentially risky materials from cattle. FDA's vigorous inspection and enforcement program has helped us achieve a compliance rate of more than 99 percent with the feed ban rule, and we intend to increase our enforcement efforts to assure compliance with our enhanced regulations. Finally, we are continuing to assist in the development of new technologies that will help us in the future improve even further these BSE protections. With today's actions, FDA will be doing more than ever before to protect the public against BSE by eliminating additional potential sources of BSE exposure."
To implement these new protections, FDA will publish two interim final rules that will take effect immediately upon publication, although there will be an opportunity for public comment after publication.
The first interim final rule will ban the following materials from FDA-regulated human food, (including dietary supplements) and cosmetics:
Any material from "downer" cattle. ("Downer" cattle are animals that cannot walk.) Any material from "dead" cattle. ("Dead" cattle are cattle that die on the farm (i.e. before reaching the slaughter plant); Specified Risk Materials (SRMs) that are known to harbor the highest concentrations of the infectious agent for BSE, such as the brain, skull, eyes, and spinal cord of cattle 30 months or older, and a portion of the small intestine and tonsils from all cattle, regardless of their age or health; and The product known as mechanically separated beef, a product which may contain SRMs. Meat obtained by Advanced Meat Recovery (an automated system for cutting meat from bones), may be used since USDA regulations do not allow the presence of SRMs in this product. The second interim final rule is designed to lower even further the risk that cattle will be purposefully or inadvertently fed prohibited protein. It was the feeding of such protein to cattle that was the route of disease transmission that led to the BSE epidemic in United Kingdom cattle in the 1980's and 1990's.
This interim final rule will implement four specific changes in FDA's present animal feed rule. First, the rule will eliminate the present exemption in the feed rule that allows mammalian blood and blood products to be fed to other ruminants as a protein source. Recent scientific evidence suggests that blood can carry some infectivity for BSE.
Second, the rule will also ban the use of "poultry litter" as a feed ingredient for ruminant animals. Poultry litter consists of bedding, spilled feed, feathers, and fecal matter that are collected from living quarters where poultry is raised. This material is then used in cattle feed in some areas of the country where cattle and large poultry raising operations are located near each other. Poultry feed may legally contain protein that is prohibited in ruminant feed, such as bovine meat and bone meal. The concern is that spillage of poultry feed in the chicken house occurs and that poultry feed (which may contain protein prohibited in ruminant feed) is then collected as part of the "poultry litter" and added to ruminant feed.
Third, the rule will ban the use of "plate waste" as a feed ingredient for ruminants. Plate waste consists of uneaten meat and other meat scraps that are currently collected from some large restaurant operations and rendered into meat and bone meal for animal feed. The use of "plate waste" confounds FDA's ability to analyze ruminant feeds for the presence of prohibited proteins, compromising the Agency's ability to fully enforce the animal feed rule.
Fourth, the rule will further minimize the possibility of cross-contamination of ruminant and non-ruminant animal feed by requiring equipment, facilities or production lines to be dedicated to non-ruminant animal feeds if they use protein that is prohibited in ruminant feed. Currently, some equipment, facilities and production lines process or handle prohibited and non-prohibited materials and make both ruminant and non-ruminant feed -- a practice which could lead to cross-contamination.
To accompany these new measures designed to provide a further layer of protection against BSE, FDA will in 2004 step up its inspections of feed mills and renderers. FDA will itself conduct 2,800 inspections and will make its resources go even further by continuing to work with state agencies to fund 3,100 contract inspections of feed mill and renderers and other firms that handle animal feed and feed ingredients. Through partnerships with states, FDA will also receive data on 700 additional inspections, for a total of 3,800 state contract and partnership inspections in 2004 alone, including annual inspections of 100 percent of all known renderers and feed mills that process products containing materials prohibited in ruminant feed.
"We have worked hard with the rendering and animal feed production industries to try and achieve full compliance with the animal feed rule," said Dr. McClellan, "and through strong education and a vigorous enforcement campaign, backed by additional inspections and resources, we intend to maintain a high level of compliance."
Dr. McClellan also noted that, in response to finding a BSE positive cow in Washington state December 23, FDA inspected and traced products at 22 facilities related to that positive cow or products from the cow, including feed mills, farms, dairy farms, calf feeder lots, slaughter houses, meat processors, transfer stations, and shipping terminals. Moreover, FDA has conducted inspections at the rendering facilities that handled materials from the positive cow, and they were found to be fully in compliance with FDA's feed rule.
To further strengthen protections for Americans, FDA/HHS intends to work with Congress to consider proposals to assure that these important protective measures will be implemented as effectively as possible.
FDA is also continuing its efforts to assist in the development of better BSE science, to achieve the same or greater confidence in BSE protection at a lower cost. For example, to enhance the ability of our public health system to detect prohibited materials in animal feed, FDA will continue to support the development and evaluation of diagnostic tests to identify prohibited materials. These tests would offer a quick and reliable method of testing animal feeds for prohibited materials and for testing other products for contamination with the agent thought to cause BSE.
FDA has publicly discussed many of the measures being announced today with stakeholders in workshops, videoconferences, and public meetings. In addition, FDA published an Advance Notice of Proposed Rulemaking in November 2002 (available online at http://www.fda.gov/OHRMS/DOCKETS/98fr/110602c.htm concerning possible changes to the animal feed rule.
Comprehensive information about FDA's work on BSE and links to other related websites are available at http://www.fda.gov.
###
http://www.fda.gov/bbs/topics/news/2004/hhs_012604.html
For Immediate Release July 9, 2004 FSIS Press Office APHIS Press Office FDA Media Relations
(202) 720-9113 (202) 734-7799 (301) 827-6242
USDA and HHS Strengthen Safeguards Against Bovine Spongiform Encephalopathy WASHINGTON, July 9, 2004--HHS Secretary Tommy G. Thompson and Agriculture Secretary Ann M. Veneman today announced three actions being taken to further strengthen existing safeguards that protect consumers against the agent that causes bovine spongiform encephalopathy (BSE, also known as "mad cow disease").
The three documents on display today include:
A joint USDA Food Safety & Inspection Service (FSIS), USDA Animal and Plant Health Inspection Service (APHIS) and Food and Drug Administration (FDA) notice that asks for public comment on additional preventive actions that are being considered concerning BSE; An interim final FDA rule that prohibits the use of certain cattle-derived materials in human food (including dietary supplements) and cosmetics; and A proposed FDA rule on recordkeeping requirements for the interim final rule relating to this ban. "Today's actions continue our strong commitment to public health protections against BSE," Secretary Thompson said. "Although our current rules are strong, when it comes to public health and safety we cannot be content with the status quo. We must continue to make sure the public is protected to the greatest extent possible."
"This Administration is committed to science-based measures to enhance and protect public health," Veneman said. "The advance notice of proposed rulemaking will allow the public the opportunity to provide their input."
"The series of firewalls already in place offer excellent protection against BSE," said Acting Commissioner of the Food and Drug Administration, Dr. Lester M. Crawford. "With these additional measures, we will make a strong system even stronger by putting into effect the most comprehensive, science-based improvements possible."
The steps already taken have been effective in protecting the American consumer from exposure to BSE. Import controls on live cattle and certain ruminant products were put in place more than 15 years ago. In 1997, FDA finalized its animal feed ban, which has been the critical safeguard to stop the spread of BSE through the U.S. cattle population by prohibiting the feeding of most mammalian protein to cattle and other ruminant animals. USDA implemented additional measures in January to ensure that no cattle tissues known to be high risk for carrying the BSE agent are included in USDA-regulated products. Finally, as became evident last December, there is a contingency response plan, developed over the past several years, that is launched immediately to contain any potential damage after a BSE positive animal is found.
To allow interested parties and stakeholders the opportunity to comment on the additional regulatory and policy measures under consideration, USDA's APHIS and FSIS, along with the FDA, developed an advance notice of proposed rulemaking that includes several additional actions the federal government is considering regarding BSE.
The ANPR also provides the public a succinct report on the work of the international review team (IRT) convened by Secretary Veneman to review the U.S. response to the single case of BSE in the United States (in a cow imported from Canada), along with a summary of the many actions already taken by each agency on BSE.
USDA's FSIS continues to seek and address comments on actions taken in relation to the BSE mitigation measures and put in place in January 2004. FSIS is also specifically seeking comments on whether a country's BSE status should be taken into account when determining whether a country's meat inspection system is equivalent to the U.S. regulations including the provisions in the FSIS interim final rules.
USDA's APHIS is specifically seeking comments on the implementation of a national animal identification system. In April, USDA announced the availability of $18 million in Commodity Credit Corporation funding to expedite development of a national animal identification system, which is currently underway. APHIS is inviting comments on when and under what circumstances the program should move from voluntary to mandatory, and which species should be covered now and over the long term.
The ANPRM also requests comment on the following measures related to animal feed, which is regulated by FDA:
removing specified risk materials (SRM's) from all animal feed, including pet food, to control the risks of cross contamination throughout feed manufacture and distribution and on the farm due to misfeeding; requiring dedicated equipment or facilities for handling and storing feed and ingredients during manufacturing and transportation, to prevent cross contamination; prohibiting the use of all mammalian and poultry protein in ruminant feed, to prevent cross contamination; and prohibiting materials from non-ambulatory disabled cattle and dead stock from use in all animal feed. FDA has reached a preliminary conclusion that it should propose to remove SRM's from all animal feed and is currently working on a proposal to accomplish this goal. Comments on these issues raised in the ANPRM are due to FDA next month.
FDA today also issued an interim final rule that prohibits the use of cattle-derived materials that can carry the BSE-infectious agent in human foods, including certain meat-based products and dietary supplements, and in cosmetics. These highÇrisk cattle-derived materials include SRM's that are known to harbor concentrations of the infectious agent for BSE, such as the brain, skull, eyes, and spinal cord of cattle 30 months of age or older, and a portion of the small intestine and tonsils from all cattle, regardless of their age. Prohibited high-risk bovine materials also include material from non-ambulatory disabled cattle, the small intestine of all cattle, material from cattle not inspected and passed for human consumption, and mechanically separated beef.
This action is consistent with the recent interim final rule issued by USDA declaring these materials to be inedible (unfit for human food) and prohibiting their use as human food.
FDA's interim final rule, in conjunction with interim final rules issued by FSIS in January 2004, will minimize human exposure to materials that scientific studies have demonstrated are likely to contain the BSE agent when derived from cattle that are infected with the disease. Consumption of products contaminated with the agent that causes BSE is the likely cause of a similar disease in people called variant Creutzfeldt-Jakob disease.
Although FDA's interim final rule has the full force and effect of law and takes effect immediately upon publication in the Federal Register, FDA is also asking for public comment on it.
In conjunction with the publication of the interim final rule, FDA is also proposing to require that manufacturers and processors of FDA-regulated human food and cosmetics containing cattle-derived material maintain records showing that prohibited materials are not used in their products. FDA is taking this action because records documenting the absence of such materials are important to ensure compliance with requirements of the interim final rule.
Publication of this USDA-FDA notice, as well as the two FDA documents, is scheduled for mid-July in the Federal Register. Comments should be submitted as directed in the addresses section of each document. Each document also provides information about how and where comments received may be viewed.
####
Note to Reporters: USDA news releases, program announcements and media advisories are available on the Internet. Go to the APHIS home page at www.aphis.usda.gov and click on the "News" button.
HHS news releases are available online at www.hhs.gov; FDA news releases can be found at www.fda.gov, which will also provide links to the documents discussed in this release.
####
http://www.fda.gov/bbs/topics/news/2004/NEW01084.html
STATEMENT BY LESTER M. CRAWFORD, D.V.M., PH.D. DEPUTY COMMISSIONER OF FOOD AND DRUGS DEPARTMENT OF HEALTH AND HUMAN SERVICES BEFORE THE COMMITTEE ON AGRICULTURE, NUTRITION, AND FORESTRY UNITED STATES SENATE JANUARY 27, 2004
Introduction
Mr. Chairman, Members of the Committee, thank you for the opportunity to participate in today’s hearing on measures taken by the Federal government to safeguard human and animal health in the United States from Bovine Spongiform Encephalopathy (BSE) and the response to the finding of a BSE-positive cow in the State of Washington. I am Dr. Lester M. Crawford, Deputy Commissioner, Food and Drug Administration (FDA or the Agency).
The mission of FDA is to protect the public health by assuring the safety and efficacy of our nation’s human and veterinary drugs, human biological products, medical devices, human and animal food supply, cosmetics, and radiation emitting products. In fulfilling this mission, FDA is the Agency responsible for assuring that all FDA-regulated products remain safe and uncompromised from BSE and related diseases. Many FDA-regulated products contain bovine ingredients, for example, heart valves, ophthalmic devices, dental products, wound dressings, injectable drugs, vaccines, soups, gravies, sausage casings, and animal feeds.
FDA has long been actively involved nationally and internationally in efforts to understand and prevent the spread of BSE. FDA collaborates extensively with the Centers for Disease Control and Prevention (CDC), the National Institutes of Health (NIH), the Animal and Plant Health Inspection Service (APHIS) and the Food Safety and Inspection Service (FSIS) within the U.S. Department of Agriculture (USDA), Customs and Border Protection (CBP), the Environmental Protection Agency (EPA), other Federal agencies, state and local jurisdictions, and with affected industries and consumer groups. Many of these activities fit within the framework of the Department of Health and Human Service’s (HHS or the Department) Bovine Spongiform Encephalopathy/Transmissible Spongiform Encephalopathy (BSE/TSE) Action Plan, which was released in August 2001. This collaboration over many years has enabled FDA to strengthen safeguards for FDA-regulated products and to respond quickly and effectively to the first case of BSE within the U.S.
Executive Summary
The mission of the Agency is to protect the public health by assuring the safety and efficacy of our nation’s human and veterinary drugs, human biological products, medical devices, human and animal food supply, cosmetics, and radiation emitting products. In fulfilling this mission, FDA is the Agency responsible for assuring that all FDA-regulated products remain safe and uncompromised from BSE and related diseases.
BSE is a progressive neurological disorder of cattle that results from infection by an unconventional transmissible agent, and was first diagnosed in the United Kingdom (U.K.) in 1986. Many FDA-regulated products contain bovine ingredients, for example, heart valves, ophthalmic devices, dental products, wound dressings, injectable drugs, vaccines, soups, gravies, sausage casings, and animal feeds and thus must be taken into consideration as part the effort to prevent infectivity by BSE.
FDA has a longstanding commitment to protecting consumers from BSE by following multiple measures designed to safeguard FDA-regulated products from possible contamination by the BSE agent. Under the Federal Food, Drug, and Cosmetic (FD&C) Act, FDA has the authority to prevent the adulteration and misbranding of FDA-regulated products. Further, for medical products that require pre-market approval (e.g., drugs under Section 505 and medical devices under Section 513 of the FD&C Act), FDA has addressed safety concerns related to BSE through requirements of the application and approval process.
The U.S. employs a robust multi-layered approach to preventing the introduction and amplification of BSE. While the goal of this approach is to achieve an extremely high level of compliance with each preventative measure, this multi-layered approach is designed to protect the U.S. consumer from exposure to the BSE infective material, and to date this approach has been working. Since 1989, USDA has prohibited the importation of live animals and animal products from BSE-positive countries. Since 1997, FDA has prohibited the use of certain mammalian proteins in the manufacture of ruminant feed. FDA continues to implement policies to keep safe all FDA-regulated products, including food, food ingredients, dietary supplements, drugs, vaccines, and cosmetics from risk of any BSE-contaminated bovine material. As a result of these multiple regulatory safeguards, the risk of exposure to BSE through products, FDA regulates remains extremely low in the U.S.
FDA’s 1997 animal feed regulation forms the basis of the Agency’s efforts to prevent the spread of BSE through animal feed. This rule prohibits the use of most mammalian protein in the manufacture of animal feeds for ruminants. FDA implemented this rule to establish in our country feeding practices consistent with the best science and epidemiological knowledge known at the time to prevent the spread of BSE throughout herds of U.S. cattle. A risk assessment sponsored by USDA and conducted by the Harvard Center for Risk Analysis, released in November 2001, identified FDA’s feed ban as one of the primary safeguards against the spread of BSE in U.S. cattle.
To maximize protection afforded by the feed regulation, FDA has developed and implemented a BSE/Ruminant Feed Ban Inspection compliance program and established the goal of 100 percent compliance. FDA’s strategy for achieving uniform compliance with the feed rule focuses on three areas: education, inspection, and enforcement. FDA and its state counterparts conduct, at least annually, targeted BSE inspections of 100 percent of known renderers, protein blenders, and feed mills processing products containing material prohibited from use in ruminant feed. Compliance by these establishments with FDA’s feed rule is estimated to be at better than 99 percent. As of December 20, 2003, FDA had received over 26,000 inspection reports (6,404 for Fiscal Year 2003). The majority of these inspections (around 70 percent) were conducted by state officials for FDA, with the remainder conducted by FDA officials. The total number of inspection reports represents 13,672 firms, 1,949 of which are active and handle materials prohibited from use in ruminant feed. The 1,949 active firms that handle prohibited material have been inspected by FDA and, as of December 31, 2003, only five were found to have significant violations, resulting in official action indicated (OAI). FDA is working with these firms to bring them into compliance.
On December 23, 2003, FDA was notified by USDA of a presumptive-positive finding of BSE in a cow in Washington State. FDA immediately initiated its BSE Emergency Response Plan. As part of the plan, FDA has been coordinately closely with USDA so that we can effectively investigate this BSE case, trace the various products involved, and take the appropriate steps to protect the public. FDA investigators and inspectors located the high risk material rendered from the infected cow, and the rendering plants placed a hold on the rendered material, which is being disposed of appropriately. I am happy to report that all of the establishments inspected by FDA during the course of the investigation were in compliance with the feed ban. In addition, to help address the concerns of foreign governments and restore confidence in American products, FDA has participated, along with USDA, in numerous meetings and consultations with foreign governments since USDA surveillance found the BSE-positive cow.
In addition to new policies and regulations, new knowledge and tools gained through applied research can greatly help us to be more effective in our regulatory mission, such as protecting the country from BSE. Several of FDA’s Centers, as well as many private laboratories, academic institutions, and other Federal agencies (most notably NIH) are also involved in significant research activities relating to TSEs. Basic areas requiring research include: increasing our understanding of prions, learning how prions are transmitted within a species and potentially between species, developing diagnostic tests for humans and animals, developing detection methods for use on regulated products, developing methods to increase or eliminate infectivity, and designing new treatments. We are optimistic about the promise of new technologies, such as better methods to quickly distinguish the species of proteins and sensors to detect abnormal prions in food. Development of these technologies can contribute significantly to the effort to prevent the spread of BSE and must be considered carefully when evaluating potential regulatory changes to address BSE.
At the time that FDA implemented the feed rule in 1997, the Agency also recognized that evolving, complex scientific and public health issues, particularly regarding BSE required the Agency to continue to assess and scrutinize the rule to ensure its integrity as a firewall against the potential for spread of BSE. To further explore ways the animal feed regulation could be improved in November 2002, FDA published an advance notice of proposed rulemaking (ANPR) soliciting information and views from the affected industries and the public on some potential changes to its current feed regulation, including ways that the animal feed regulation could be strengthened. Although the risk of exposure to BSE in the U.S. remains extremely low and the measures in place are working, as a result of the recently discovered infected cow in the state of Washington, the Agency is evaluating the appropriateness of additional science-based measures to further strengthen our current protections.
Yesterday, Department Secretary Tommy Thompson and FDA Commissioner Mark McClellan announced several additional public health measures to further strengthen the current robust safeguards that help protect Americans from exposure to the agent that causes BSE and help prevent the spread of BSE in U.S. cattle. These measures relate to both protections for foods intended for human consumption as well as additional measures to strengthen FDA’s 1997 final rule regulating animal feed. With respect to human foods, FDA announced that it will extend to FDA-regulated foods, dietary supplements and cosmetics, restrictions on using specified risk materials that would complement the recent USDA announcements. Concerning animal feed, the Agency announced a series of measures designed to lower even further the risk that cattle will be purposefully or inadvertently fed “ruminant” proteins, including, eliminating an exemption in the feed rule that allows mammalian blood and blood products at slaughter to be fed to ruminants as a protein source; banning the use of “poultry litter” as a feed ingredient for cattle and other ruminants; prohibiting the use of “plate waste” as a feed ingredient for ruminants, including cattle; and taking steps to further minimize the possibility of cross-contamination of animal feed via equipment, facilities or production lines.
Finally, FDA is increasing its inspections of feed mills and renderers in 2004. Our 2001 base funding for BSE-related activities was $3.8 million. We shifted resources internally in 2001 and received a substantial increase from Congress in 2002. Our funded level for 2004 is currently approximately $21.5 million, almost a five-fold increase over the 2001 base. FDA will itself conduct 2,800 inspections and will make its resources go even further by working with state agencies to fund 3,100 contract inspections of feed mills and renderers and other firms that handle animal feed and feed ingredients. Through partnerships with states, FDA will also receive data on 700 additional inspections, for a total of 3,800 state contract and partnership inspections in 2004. These inspections would include 100 percent of all known renderers and feed mills that process products containing prohibited materials.
The Agency looks forward to continuing to assist Congress as it evaluates the risks associated with BSE, identifies opportunities to promote technologies that will detect and prevent the spread of BSE, and considers science-based approaches to further strengthen regulatory protections and bolster the resources available to assist Federal, state, local and private efforts to assure that BSE does not present a threat to human or animal health in the U.S.
see full text ;
http://madcowfeed.blogspot.com/2008/04/substances-prohibited-from-use-in.html
OH, that's right, old lester sold out to the highest bidder $$$
Ex-FDA Chief Faces Fines in Stock Case By ANDREW BRIDGES, Associated Press Writer 1:55 PM PST, January 19, 2007
SNIP...SEE FULL TEXT ;
http://madcowfeed.blogspot.com/2009/04/docket-no-fda2002n0031-formerly-docket.html
WHAT MAD COW FEED BAN, THE 1997 FEED BAN WAS NOTHING BUT INK ON PAPER ;
10,000,000+ LBS. of PROHIBITED BANNED MAD COW FEED I.E. BLOOD LACED MBM IN COMMERCE USA 2007
Date: March 21, 2007 at 2:27 pm PST
RECALLS AND FIELD CORRECTIONS: VETERINARY MEDICINES -- CLASS II
___________________________________
PRODUCT
Bulk cattle feed made with recalled Darling's 85% Blood Meal, Flash Dried, Recall # V-024-2007
CODE
Cattle feed delivered between 01/12/2007 and 01/26/2007
RECALLING FIRM/MANUFACTURER
Pfeiffer, Arno, Inc, Greenbush, WI. by conversation on February 5, 2007.
Firm initiated recall is ongoing.
REASON
Blood meal used to make cattle feed was recalled because it was cross- contaminated with prohibited bovine meat and bone meal that had been manufactured on common equipment and labeling did not bear cautionary BSE statement.
VOLUME OF PRODUCT IN COMMERCE
42,090 lbs.
DISTRIBUTION
WI
___________________________________
PRODUCT
Custom dairy premix products: MNM ALL PURPOSE Pellet, HILLSIDE/CDL Prot- Buffer Meal, LEE, M.-CLOSE UP PX Pellet, HIGH DESERT/ GHC LACT Meal, TATARKA, M CUST PROT Meal, SUNRIDGE/CDL PROTEIN Blend, LOURENZO, K PVM DAIRY Meal, DOUBLE B DAIRY/GHC LAC Mineral, WEST PIONT/GHC CLOSEUP Mineral, WEST POINT/GHC LACT Meal, JENKS, J/COMPASS PROTEIN Meal, COPPINI - 8# SPECIAL DAIRY Mix, GULICK, L-LACT Meal (Bulk), TRIPLE J - PROTEIN/LACTATION, ROCK CREEK/GHC MILK Mineral, BETTENCOURT/GHC S.SIDE MK-MN, BETTENCOURT #1/GHC MILK MINR, V&C DAIRY/GHC LACT Meal, VEENSTRA, F/GHC LACT Meal, SMUTNY, A- BYPASS ML W/SMARTA, Recall # V-025-2007
CODE
The firm does not utilize a code - only shipping documentation with commodity and weights identified.
RECALLING FIRM/MANUFACTURER
Rangen, Inc, Buhl, ID, by letters on February 13 and 14, 2007. Firm initiated recall is complete.
REASON
Products manufactured from bulk feed containing blood meal that was cross contaminated with prohibited meat and bone meal and the labeling did not bear cautionary BSE statement.
VOLUME OF PRODUCT IN COMMERCE
9,997,976 lbs.
DISTRIBUTION
ID and NV
END OF ENFORCEMENT REPORT FOR MARCH 21, 2007
http://www.fda.gov/bbs/topics/enforce/2007/ENF00996.html
NEW URL
http://www.fda.gov/Safety/Recalls/EnforcementReports/2007/ucm120446.htm
Thursday, March 19, 2009 MILLIONS AND MILLIONS OF POUNDS OF MAD COW FEED IN COMMERCE USA WITH ONGOING 12 YEARS OF DENIAL NOW, WHY IN THE WORLD DO WE TO TALK ABOUT THIS ANYMORE $$$
http://madcowfeed.blogspot.com/2009/03/millions-and-millions-of-pounds-of-mad.html
Judge rules poultry-litter fertilizer is solid waste
By CURTIS KILLMAN World Staff Writer Published: 8/15/2009 2:25 AM Last Modified: 8/15/2009 3:37 AM
Poultry companies on Friday lost a bid to have part of the state's Illinois River watershed pollution lawsuit dismissed by claiming that poultry litter wasn't solid waste.
U.S. District Judge Gregory Frizzell ruled that poultry litter, a mixture of poultry waste and bedding material, may be considered a solid waste if it is applied in excessive amounts on fields as fertilizer.
"Today's ruling is important in that it demonstrates that the defendants can be held responsible for the over-application runoff and leaching that endangers human health and the environment," Charlie Price, a spokesman for Attorney General Drew Edmondson, said in an e-mail.
The ruling came amid a series of challenges fielded by Frizzell on Thursday and Friday, just prior to a scheduled Sept. 21 trial date.
The state, led by Edmondson, is suing 12 poultry companies, claiming that they are legally responsible for the handling and disposal of poultry waste that has damaged portions of the Illinois River watershed in Oklahoma.
The state has claimed that poultry waste is a solid waste and thus subject to federal law barring illegal disposal.
The poultry industry challenged the use of that federal law, claiming that poultry litter was not a solid waste.
"Poultry litter is a widely utilized fertilizer, which provides soil nutrients, increases crop yields and outperforms commercial fertilizers," attorneys for the poultry industry wrote in a court filing.
In another ruling, the poultry
companies lost a bid to revoke a settlement agreement between another poultry company and the state.
Frizzell ruled a settlement agreement involving Willow Brook Foods Inc. and the state was fair and reasonable. Willow Brook was originally included in a group of 13 poultry companies sued by the state in the pollution case.
The remaining 12 poultry companies had objected to the settlement agreement after it was announced in May.
The agreement called for Willow Brook Foods, now called Cold Zone Inc., to pay $120,000 as part of a deal to settle claims made by the state in the pollution case.
Frank Evans, an attorney for Willow Brook Foods, said while the $120,000 may not be a lot of money for other poultry companies named in the lawsuit, "I can assure you it is a very large amount of money for my client."
In other matters, Frizzell heard a request from the state to reconsider his ruling that the state could not pursue damages totaling more than $600 million. In July, the judge said the state could not pursue damages because it failed to properly include the Cherokee Nation in the lawsuit.
Frizzell said he would rule later on the reconsideration request
http://www.tulsaworld.com/news/article.aspx?subjectid=14&articleid=20090815_11_A1_Poultr953527&allcom=1
LETS see now, the one mad cow that was covered up for 7+ months due to the MRR policy being born, then finally, after an act of Congress, confirmed by England, then the other highly suspect mad cow in Texas that was never, ever tested, just wisk away to be rendered, and the other suspect mad cow that tissue samples sat around for another 4 months, for the same reaseon as the 7+ month suspect and later confirmed mad cow (MRR being born, could not have no mad cows before that policy was in effect). see history below ;
Tuesday, July 14, 2009
U.S. Emergency Bovine Spongiform Encephalopathy Response Plan Summary and BSE Red Book Date: February 14, 2000 at 8:56 am PST
WHERE did we go wrong $$$
http://madcowtesting.blogspot.com/2009/07/us-emergency-bovine-spongiform.html
Transgenic mice expressing porcine prion protein resistant to classical scrapie but susceptible to sheep bovine spongiform encephalopathy and atypical scrapie. Emerg Infect Dis. 2009 Aug; [Epub ahead of print]
http://nor-98.blogspot.com/2009/07/transgenic-mice-expressing-porcine.html
Transmissible mink encephalopathy - review of the etiology
http://transmissible-mink-encephalopathy.blogspot.com/2009/07/transmissible-mink-encephalopathy.html
Wednesday, July 1, 2009
Nor98 scrapie identified in the United States J Vet Diagn Invest 21:454-463 (2009)
http://nor-98.blogspot.com/2009/07/nor98-scrapie-identified-in-united.html
Wednesday, August 05, 2009 Rate of CWD infection increases in core area WISCONSIN
http://chronic-wasting-disease.blogspot.com/2009/08/rate-of-cwd-infection-increases-in-core.html
Monday, June 01, 2009 Biochemical typing of pathological prion protein in aging cattle with BSE
SOMETHING TO PONDER ???
O.K. confusious asks, IF all these new atypical BSEs i.e. new strains of mad cow disease is just an 'OLD COW PRION DISEASE', why then can not the 'old human prion disease' such as the sporadic CJD, be from an 'old cow prion disease', same as the nvCJD 'young people mad cow disease' (which also happens in 74 year old), but why cannot the 'old cow prion diseases', i.e. l-BSE, h-BSE, and ibncBSE, cause the 'old people prion disease', which looks like sporadic CJD. seems that is what some of the pathology is showing ???
OH, that probably makes too much sense, and that the only answer could be that it's all just a happenstance of bad luck and or a spontaneous event, that just happens out of the clear blue sky $$$
IF this is the case, then where are all the SPONTANEOUS BSE CASES OF MAD COW DISEASE IN THE U.S.A., AND WHERE HAVE THEY BEEN BURIED IN THE USA OVER THE LAST 25 YEARS ???
http://bse-atypical.blogspot.com/2009/06/biochemical-typing-of-pathological.html
Atypical BSE North America Update February 2009
http://bse-atypical.blogspot.com/2009/02/atypical-bse-north-america-update.html
Tuesday, August 11, 2009
Characteristics of Established and Proposed Sporadic Creutzfeldt-Jakob Disease Variants
http://creutzfeldt-jakob-disease.blogspot.com/2009/08/characteristics-of-established-and.html
Sunday, August 09, 2009
CJD...Straight talk with...James Ironside...and...Terry Singeltary... 2009
http://creutzfeldt-jakob-disease.blogspot.com/2009/08/cjdstraight-talk-withjames.html
Monday, July 27, 2009
U.S.A. HIDING MAD COW DISEASE VICTIMS AS SPORADIC CJD ?
WHY DID THIS VIDEO NOT SHOW ON EVERY NEWS CHANNEL IN THE U.S.A. $$$
IT IS A DAMNING VIDEO !!!
I WATCHED THIS RECENTLY, and had never seen it. i was so mad, i was spitting nails out faster than a framing gun.
WHY DID THE CANADIAN MEDIA ONLY PRESENT THIS TO THE U.S.A. PUBLIC (thank you very much though), and why has the U.S.A. MEDIA FAILED US ???
WHY DID R-CALF NOT SHOW THIS ??? where was r-calf when you needed them back then $$$
SNIP...
Monday, July 27, 2009
U.S.A. HIDING MAD COW DISEASE VICTIMS AS SPORADIC CJD ?
http://creutzfeldt-jakob-disease.blogspot.com/2009/07/usa-hiding-mad-cow-disease-victims-as.html
Docket APHIS-2006-0026 Docket Title Bovine Spongiform Encephalopathy; Animal Identification and Importation of Commodities Docket Type Rulemaking Document APHIS-2006-0026-0001 Document Title Bovine Spongiform Encephalopathy; Minimal-Risk Regions, Identification of Ruminants and Processing and Importation of Commodities Public Submission APHIS-2006-0026-0012 Public Submission Title Comment from Terry S Singletary
http://www.regulations.gov/fdmspublic/component/main?main=DocumentDetail&o=09000064801e47e1
Docket APHIS-2006-0041 Docket Title Bovine Spongiform Encephalopathy; Minimal-Risk Regions; Importation of Live Bovines and Products Derived from Bovines Commodities Docket Type Rulemaking Document APHIS-2006-0041-0001 Document Title Bovine Spongiform Encephalopathy; Minimal-Risk Regions; Importation of Live Bovines and Products Derived From Bovines Public Submission APHIS-2006-0041-0028 Public Submission Title Comment from Terry S Singletary
Comment 2006-2007 USA AND OIE POISONING GLOBE WITH BSE MRR POLICY
THE USA is in a most unique situation, one of unknown circumstances with human and animal TSE. THE USA has the most documented TSE in different species to date, with substrains growing in those species (BSE/BASE in cattle and CWD in deer and elk, there is evidence here with different strains), and we know that sheep scrapie has over 20 strains of the typical scrapie with atypical scrapie documented and also BSE is very likely to have passed to sheep. all of which have been rendered and fed back to animals for human and animal consumption, a frightening scenario. WE do not know the outcome, and to play with human life around the globe with the very likely TSE tainted products from the USA, in my opinion is like playing Russian roulette, of long duration, with potential long and enduring consequences, of which once done, cannot be undone. These are the facts as I have come to know through daily and extensive research of TSE over 9 years, since 12/14/97. I do not pretend to have all the answers, but i do know to continue to believe in the ukbsenvcjd only theory of transmission to humans of only this one strain from only this one TSE from only this one part of the globe, will only lead to further failures, and needless exposure to humans from all strains of TSE, and possibly many more needless deaths from TSE via a multitude of proven routes and sources via many studies with primates and rodents and other species.
MY personal belief, since you ask, is that not only the Canadian border, but the USA border, and the Mexican border should be sealed up tighter than a drum for exporting there TSE tainted products, until a validated, 100% sensitive test is available, and all animals for human and animal consumption are tested. all we are doing is the exact same thing the UK did with there mad cow poisoning when they exported it all over the globe, all the while knowing what they were doing. this BSE MRR policy is nothing more than a legal tool to do just exactly what the UK did, thanks to the OIE and GW, it's legal now. and they executed Saddam for poisoning ???
go figure. ...
http://www.regulations.gov/fdmspublic/component/main?main=DocumentDetail&o=09000064801f8151
Docket APHIS-2006-0041 Docket Title Bovine Spongiform Encephalopathy; Minimal-Risk Regions; Importation of Live Bovines and Products Derived from Bovines Commodities Docket Type Rulemaking Document APHIS-2006-0041-0001 Document Title Bovine Spongiform Encephalopathy; Minimal-Risk Regions; Importation of Live Bovines and Products Derived From Bovines Public Submission APHIS-2006-0041-0028.1 Public Submission Title Attachment to Singletary comment
January 28, 2007
Greetings APHIS,
I would kindly like to submit the following to ;
BSE; MRR; IMPORTATION OF LIVE BOVINES AND PRODUCTS DERIVED FROM BOVINES [Docket No. APHIS-2006-0041] RIN 0579-AC01
http://www.regulations.gov/fdmspublic/ContentViewer?objectId=09000064801f8152&disposition=attachment&contentType=msw8
Thursday, April 9, 2009
Docket No. FDA2002N0031 (formerly Docket No. 2002N0273) RIN 0910AF46 Substances Prohibited From Use in Animal Food or Feed; Final Rule: Proposed
http://madcowfeed.blogspot.com/2009/04/docket-no-fda2002n0031-formerly-docket.html
IN A NUT SHELL ; $$$
(Adopted by the International Committee of the OIE on 23 May 2006)
11. Information published by the OIE is derived from appropriate declarations made by the official Veterinary Services of Member Countries.The OIE is not responsible for inaccurate publication of country disease status based on inaccurate information or changes in epidemiological status or other significant events that were not promptly reported to then Central Bureau............
http://www.oie.int/eng/Session2007/RF2006.pdf
PAUL BROWN COMMENT TO ME ON THIS ISSUE
Tuesday, September 12, 2006 11:10 AM
"Actually, Terry, I have been critical of the USDA handling of the mad cow issue for some years, and with Linda Detwiler and others sent lengthy detailed critiques and recommendations to both the USDA and the Canadian Food Agency."
http://lists.ifas.ufl.edu/cgi-bin/wa.exe?A2=ind0703&L=sanet-mg&T=0&P=8125
http://bse-atypical.blogspot.com/2009/02/atypical-bse-north-america-update.html
The logic behind the reasons not to let test for TSE in the USA because of The Virus Serum Toxin Act of 1913 and or because of the recent letter from the USAHA (see letter below) bring forth, are totally bogus. NO one could screw the testing up any worse than the USDA has done in the past. The OIG and the GAO has shown this time and time again. The 2004 Enhanced BSE surveillance program where some 275,000+ cattle were tested for BSE was proven to be terribly flawed from the beginning. This documented time and time again. Even Paul Brown, known and respected TSE scientist, former TSE expert for the CDC said he had ''absolutely no confidence in USDA tests before one year ago'', and this was on March 15, 2006 ;
"The fact the Texas cow showed up fairly clearly implied the existence of other undetected cases," Dr. Paul Brown, former medical director of the National Institutes of Health's Laboratory for Central Nervous System Studies and an expert on mad cow-like diseases, told United Press International. "The question was, 'How many?' and we still can't answer that."
Brown, who is preparing a scientific paper based on the latest two mad cow cases to estimate the maximum number of infected cows that occurred in the United States, said he has "absolutely no confidence in USDA tests before one year ago" because of the agency's reluctance to retest the Texas cow that initially tested positive.
USDA officials finally retested the cow and confirmed it was infected seven months later, but only at the insistence of the agency's inspector general.
"Everything they did on the Texas cow makes everything USDA did before 2005 suspect," Brown said. ...snip...end
http://www.upi.com/
CDC - Bovine Spongiform Encephalopathy and Variant Creutzfeldt ... Dr. Paul Brown is Senior Research Scientist in the Laboratory of Central Nervous System ... Address for correspondence: Paul Brown, Building 36, Room 4A-05, ...
http://www.cdc.gov/ncidod/eid/vol7no1/brown.htm
Sunday, April 12, 2009
r-calf and the USA mad cow problem, don't look, don't find, and then blame Canada
http://prionunitusaupdate2008.blogspot.com/2009/04/r-calf-and-usa-mad-cow-problem-dont.html
TSS
Would you feed animal waste to your dog or cat? Probably not. It’s dirty, disgusting and clearly unsafe. Unfortunately, not all animals are so lucky. In areas of the United States where large cattle and poultry operations coexist, poultry litter is routinely fed to cows. Poultry litter consists primarily of manure, feathers, spilled feed and bedding material that accumulate on the floors of the buildings that house chickens and turkeys. It can contain disease-causing bacteria, antibiotics, toxic heavy metals, feed ingredients normally prohibited for cattle, and even foreign objects such as dead rodents, rocks, nails and glass. Surprisingly, this unhealthy and inhumane practice is legal. We need your help to convince the government to ban litter feeding NOW.
http://www.foodanimalconcerns.org/humane4.htm
UNITED STATES DEPARTMENT OF HEALTH AND HUMAN SERVICES FOOD AND DRUG ADMINISTRATION Petition to Declare Poultry Litter) as a Food Additive and to) Ban Its Use as Cattle Feed) Docket No. ______________ submitted by FOOD ANIMAL CONCERNS TRUST August 12, 2009 Richard Wood Executive Director PO Box 14599 Chicago, IL 60614 Phone: (773) 525-4952
http://www.foodanimalconcerns.org/PDF/FDA%20Chicken%20Litter%20Petition_final.pdf
FILTHY FEED REPORT
http://www.foodanimalconcerns.org/PDF/FDA%20Chicken%20Litter%20Petition_final.pdf
For Release: Immediate Contact: Jacki Rossi, (773) 525-4952August 13, 2009 mhtml:%7B33B38F65-8D2E-434D-8F9B-8BDCD77D3066%7Dmid://00000069/!x-usc:mailto:jrossi@foodanimalconcerns.orgFACT Petitions FDA to Ban Poultry Litter as Cattle Feed New campaign launches to end dangerous agricultural practice
http://www.foodanimalconcerns.org/PDF/filthyfeed_release_FINAL.pdf
FDA asked to ban poultry litter from feed 17 Aug 2009
A consumer advocacy group Food Animal Concern Trust (FACT) is urging the Food and Drug Administration (FDA) to ban the use of poultry litter in cattle feed through a petition on its website.
The FDA considered such a ban after the nation’s first case of mad cow disease surfaced in 2003 but never took the action, reports state. On the Food Animal Concern Trust (FACT) website, it states:
"Would you feed animal waste to your dog or cat? Probably not. It's dirty, disgusting and intuitively just seems wrong. Unfortunately, not all animals are so lucky. In areas of the United States where large cattle and poultry operations coexist, chicken waste (or, more accurately, 'poultry litter') is routinely fed to cows. Poultry litter consists primarily of manure, feathers, spilled feed and bedding material that accumulate on the floors of the buildings that chickens and turkeys. It can contain disease-causing bacteria, antibiotics, toxic heavy metals, substances that cause Mad Cow Disease, and even foreign objects such as dead rodents, rocks, nails and glass. Surprisingly, this unhealthy and inhumane practice is legal and poorly monitored - creating unacceptable risks to human and animal health. The FDA needs to ban the use of animal waste as animal feed before human and animal health is further compromised".
The website goes on to say that many prominent groups have endorsed its efforts to elicit an FDA ban on feeding poultry litter to cattle. These groups include the Center for Food Safety, the Center for Science in the Public Interest, Consumer Federation of America, Consumers Union, Food & Water Watch, Humane Society of the United States, Institute for Agriculture and Trade Policy, National Sustainable Agriculture Coalition, etc.
http://www.allaboutfeed.net/news/fda-asked-to-ban-poultry-litter-from-feed-3487.html
and don't think birds cannot get mad cow disease, what about BIG BIRD I.E. RED TAIL OSTRICH ;-)
DAMN, i cannot find the original paper.........i have the report somewhere here ???
A contribution to the neuropathology of the red-necked ostrich (struthio camelus) - spongiform encephalopathy
spongiform encephlopathy in the red-necked ostrich (struthio camelus). A case history
YES !
A CONTRIBUTION TO THE NEUROPATHOLOGY OF THE RED-NECKED OSTRICH (STRUTHIO CAMELUS) - SPONGIFORM ENCEPHALOPATHY
http://www.bseinquiry.gov.uk/files/sc/Seac10/tab06.pdf
re--FDA asked to ban poultry litter from feed 17 Aug 2009
POMISES, POMISES, PROMISES...........not......LIES, LIES, AND MORE LIES $$$
*** DO NOT forget what was originally promised years ago !!!
Press Release FOR IMMEDIATE RELEASE Monday, Jan. 26, 2004 FDA Press Office 301-827-6242
Expanded "Mad Cow" Safeguards Announced to Strengthen Existing Firewalls Against BSE Transmission HHS Secretary Tommy G. Thompson today announced several new public health measures, to be implemented by the Food and Drug Administration (FDA), to strengthen significantly the multiple existing firewalls that protect Americans from exposure to the agent thought to cause bovine spongiform encephalopathy (BSE, also known as mad cow disease) and that help prevent the spread of BSE in U.S. cattle.
The existing multiple firewalls, developed by both the U.S. Department of Agriculture (USDA) and HHS, have been extremely effective in protecting the American consumer from exposure to BSE. The first firewall is based on import controls started in 1989. A second firewall is surveillance of the U.S. cattle population for the presence of BSE, a USDA firewall that led to the finding of the BSE cow in December. The third firewall is FDA's 1997 animal feed ban, which is the critical safeguard to help prevent the spread of BSE through cattle herds by prohibiting the feeding of most mammalian protein to ruminant animals, including cattle. The fourth firewall, recently announced by USDA, makes sure that no bovine tissues known to be at high risk for carrying the agent of BSE enter the human food supply regulated by USDA. The fifth firewall is effective response planning to contain the potential for any damage from a BSE positive animal, if one is discovered. This contingency response plan, which had been developed over the past several years, was initiated immediately upon the discovery of a BSE positive cow in Washington State December 23.
The new safeguards being announced today are science-based and further bolster these already effective safeguards.
Specifically, HHS intends to ban from human food (including dietary supplements), and cosmetics a wide range of bovine-derived material so that the same safeguards that protect Americans from exposure to the agent of BSE through meat products regulated by USDA also apply to food products that FDA regulates.
FDA will also prohibit certain currently allowed feeding and manufacturing practices involving feed for cattle and other ruminant animals. These additional measures will further strengthen FDA's 1997 "animal feed" rule.
"Today's actions will make strong public health protections against BSE even stronger," Secretary Thompson said. "Although the current animal feed rule provides a strong barrier against the further spread of BSE, we must never be satisfied with the status quo where the health and safety of our animals and our population is at stake. The science and our own experience and knowledge in this area are constantly evolving. Small as the risk may already be, this is the time to make sure the public is protected to the greatest extent possible."
"Today we are bolstering our BSE firewalls to protect the public," said FDA Commissioner Mark B. McClellan, M.D., Ph.D. "We are further strengthening our animal feed rule, and we are taking additional steps to further protect the public from being exposed to any potentially risky materials from cattle. FDA's vigorous inspection and enforcement program has helped us achieve a compliance rate of more than 99 percent with the feed ban rule, and we intend to increase our enforcement efforts to assure compliance with our enhanced regulations. Finally, we are continuing to assist in the development of new technologies that will help us in the future improve even further these BSE protections. With today's actions, FDA will be doing more than ever before to protect the public against BSE by eliminating additional potential sources of BSE exposure."
To implement these new protections, FDA will publish two interim final rules that will take effect immediately upon publication, although there will be an opportunity for public comment after publication.
The first interim final rule will ban the following materials from FDA-regulated human food, (including dietary supplements) and cosmetics:
Any material from "downer" cattle. ("Downer" cattle are animals that cannot walk.) Any material from "dead" cattle. ("Dead" cattle are cattle that die on the farm (i.e. before reaching the slaughter plant); Specified Risk Materials (SRMs) that are known to harbor the highest concentrations of the infectious agent for BSE, such as the brain, skull, eyes, and spinal cord of cattle 30 months or older, and a portion of the small intestine and tonsils from all cattle, regardless of their age or health; and The product known as mechanically separated beef, a product which may contain SRMs. Meat obtained by Advanced Meat Recovery (an automated system for cutting meat from bones), may be used since USDA regulations do not allow the presence of SRMs in this product. The second interim final rule is designed to lower even further the risk that cattle will be purposefully or inadvertently fed prohibited protein. It was the feeding of such protein to cattle that was the route of disease transmission that led to the BSE epidemic in United Kingdom cattle in the 1980's and 1990's.
This interim final rule will implement four specific changes in FDA's present animal feed rule. First, the rule will eliminate the present exemption in the feed rule that allows mammalian blood and blood products to be fed to other ruminants as a protein source. Recent scientific evidence suggests that blood can carry some infectivity for BSE.
Second, the rule will also ban the use of "poultry litter" as a feed ingredient for ruminant animals. Poultry litter consists of bedding, spilled feed, feathers, and fecal matter that are collected from living quarters where poultry is raised. This material is then used in cattle feed in some areas of the country where cattle and large poultry raising operations are located near each other. Poultry feed may legally contain protein that is prohibited in ruminant feed, such as bovine meat and bone meal. The concern is that spillage of poultry feed in the chicken house occurs and that poultry feed (which may contain protein prohibited in ruminant feed) is then collected as part of the "poultry litter" and added to ruminant feed.
Third, the rule will ban the use of "plate waste" as a feed ingredient for ruminants. Plate waste consists of uneaten meat and other meat scraps that are currently collected from some large restaurant operations and rendered into meat and bone meal for animal feed. The use of "plate waste" confounds FDA's ability to analyze ruminant feeds for the presence of prohibited proteins, compromising the Agency's ability to fully enforce the animal feed rule.
Fourth, the rule will further minimize the possibility of cross-contamination of ruminant and non-ruminant animal feed by requiring equipment, facilities or production lines to be dedicated to non-ruminant animal feeds if they use protein that is prohibited in ruminant feed. Currently, some equipment, facilities and production lines process or handle prohibited and non-prohibited materials and make both ruminant and non-ruminant feed -- a practice which could lead to cross-contamination.
To accompany these new measures designed to provide a further layer of protection against BSE, FDA will in 2004 step up its inspections of feed mills and renderers. FDA will itself conduct 2,800 inspections and will make its resources go even further by continuing to work with state agencies to fund 3,100 contract inspections of feed mill and renderers and other firms that handle animal feed and feed ingredients. Through partnerships with states, FDA will also receive data on 700 additional inspections, for a total of 3,800 state contract and partnership inspections in 2004 alone, including annual inspections of 100 percent of all known renderers and feed mills that process products containing materials prohibited in ruminant feed.
"We have worked hard with the rendering and animal feed production industries to try and achieve full compliance with the animal feed rule," said Dr. McClellan, "and through strong education and a vigorous enforcement campaign, backed by additional inspections and resources, we intend to maintain a high level of compliance."
Dr. McClellan also noted that, in response to finding a BSE positive cow in Washington state December 23, FDA inspected and traced products at 22 facilities related to that positive cow or products from the cow, including feed mills, farms, dairy farms, calf feeder lots, slaughter houses, meat processors, transfer stations, and shipping terminals. Moreover, FDA has conducted inspections at the rendering facilities that handled materials from the positive cow, and they were found to be fully in compliance with FDA's feed rule.
To further strengthen protections for Americans, FDA/HHS intends to work with Congress to consider proposals to assure that these important protective measures will be implemented as effectively as possible.
FDA is also continuing its efforts to assist in the development of better BSE science, to achieve the same or greater confidence in BSE protection at a lower cost. For example, to enhance the ability of our public health system to detect prohibited materials in animal feed, FDA will continue to support the development and evaluation of diagnostic tests to identify prohibited materials. These tests would offer a quick and reliable method of testing animal feeds for prohibited materials and for testing other products for contamination with the agent thought to cause BSE.
FDA has publicly discussed many of the measures being announced today with stakeholders in workshops, videoconferences, and public meetings. In addition, FDA published an Advance Notice of Proposed Rulemaking in November 2002 (available online at http://www.fda.gov/OHRMS/DOCKETS/98fr/110602c.htm concerning possible changes to the animal feed rule.
Comprehensive information about FDA's work on BSE and links to other related websites are available at http://www.fda.gov.
###
http://www.fda.gov/bbs/topics/news/2004/hhs_012604.html
For Immediate Release July 9, 2004 FSIS Press Office APHIS Press Office FDA Media Relations
(202) 720-9113 (202) 734-7799 (301) 827-6242
USDA and HHS Strengthen Safeguards Against Bovine Spongiform Encephalopathy WASHINGTON, July 9, 2004--HHS Secretary Tommy G. Thompson and Agriculture Secretary Ann M. Veneman today announced three actions being taken to further strengthen existing safeguards that protect consumers against the agent that causes bovine spongiform encephalopathy (BSE, also known as "mad cow disease").
The three documents on display today include:
A joint USDA Food Safety & Inspection Service (FSIS), USDA Animal and Plant Health Inspection Service (APHIS) and Food and Drug Administration (FDA) notice that asks for public comment on additional preventive actions that are being considered concerning BSE; An interim final FDA rule that prohibits the use of certain cattle-derived materials in human food (including dietary supplements) and cosmetics; and A proposed FDA rule on recordkeeping requirements for the interim final rule relating to this ban. "Today's actions continue our strong commitment to public health protections against BSE," Secretary Thompson said. "Although our current rules are strong, when it comes to public health and safety we cannot be content with the status quo. We must continue to make sure the public is protected to the greatest extent possible."
"This Administration is committed to science-based measures to enhance and protect public health," Veneman said. "The advance notice of proposed rulemaking will allow the public the opportunity to provide their input."
"The series of firewalls already in place offer excellent protection against BSE," said Acting Commissioner of the Food and Drug Administration, Dr. Lester M. Crawford. "With these additional measures, we will make a strong system even stronger by putting into effect the most comprehensive, science-based improvements possible."
The steps already taken have been effective in protecting the American consumer from exposure to BSE. Import controls on live cattle and certain ruminant products were put in place more than 15 years ago. In 1997, FDA finalized its animal feed ban, which has been the critical safeguard to stop the spread of BSE through the U.S. cattle population by prohibiting the feeding of most mammalian protein to cattle and other ruminant animals. USDA implemented additional measures in January to ensure that no cattle tissues known to be high risk for carrying the BSE agent are included in USDA-regulated products. Finally, as became evident last December, there is a contingency response plan, developed over the past several years, that is launched immediately to contain any potential damage after a BSE positive animal is found.
To allow interested parties and stakeholders the opportunity to comment on the additional regulatory and policy measures under consideration, USDA's APHIS and FSIS, along with the FDA, developed an advance notice of proposed rulemaking that includes several additional actions the federal government is considering regarding BSE.
The ANPR also provides the public a succinct report on the work of the international review team (IRT) convened by Secretary Veneman to review the U.S. response to the single case of BSE in the United States (in a cow imported from Canada), along with a summary of the many actions already taken by each agency on BSE.
USDA's FSIS continues to seek and address comments on actions taken in relation to the BSE mitigation measures and put in place in January 2004. FSIS is also specifically seeking comments on whether a country's BSE status should be taken into account when determining whether a country's meat inspection system is equivalent to the U.S. regulations including the provisions in the FSIS interim final rules.
USDA's APHIS is specifically seeking comments on the implementation of a national animal identification system. In April, USDA announced the availability of $18 million in Commodity Credit Corporation funding to expedite development of a national animal identification system, which is currently underway. APHIS is inviting comments on when and under what circumstances the program should move from voluntary to mandatory, and which species should be covered now and over the long term.
The ANPRM also requests comment on the following measures related to animal feed, which is regulated by FDA:
removing specified risk materials (SRM's) from all animal feed, including pet food, to control the risks of cross contamination throughout feed manufacture and distribution and on the farm due to misfeeding; requiring dedicated equipment or facilities for handling and storing feed and ingredients during manufacturing and transportation, to prevent cross contamination; prohibiting the use of all mammalian and poultry protein in ruminant feed, to prevent cross contamination; and prohibiting materials from non-ambulatory disabled cattle and dead stock from use in all animal feed. FDA has reached a preliminary conclusion that it should propose to remove SRM's from all animal feed and is currently working on a proposal to accomplish this goal. Comments on these issues raised in the ANPRM are due to FDA next month.
FDA today also issued an interim final rule that prohibits the use of cattle-derived materials that can carry the BSE-infectious agent in human foods, including certain meat-based products and dietary supplements, and in cosmetics. These highÇrisk cattle-derived materials include SRM's that are known to harbor concentrations of the infectious agent for BSE, such as the brain, skull, eyes, and spinal cord of cattle 30 months of age or older, and a portion of the small intestine and tonsils from all cattle, regardless of their age. Prohibited high-risk bovine materials also include material from non-ambulatory disabled cattle, the small intestine of all cattle, material from cattle not inspected and passed for human consumption, and mechanically separated beef.
This action is consistent with the recent interim final rule issued by USDA declaring these materials to be inedible (unfit for human food) and prohibiting their use as human food.
FDA's interim final rule, in conjunction with interim final rules issued by FSIS in January 2004, will minimize human exposure to materials that scientific studies have demonstrated are likely to contain the BSE agent when derived from cattle that are infected with the disease. Consumption of products contaminated with the agent that causes BSE is the likely cause of a similar disease in people called variant Creutzfeldt-Jakob disease.
Although FDA's interim final rule has the full force and effect of law and takes effect immediately upon publication in the Federal Register, FDA is also asking for public comment on it.
In conjunction with the publication of the interim final rule, FDA is also proposing to require that manufacturers and processors of FDA-regulated human food and cosmetics containing cattle-derived material maintain records showing that prohibited materials are not used in their products. FDA is taking this action because records documenting the absence of such materials are important to ensure compliance with requirements of the interim final rule.
Publication of this USDA-FDA notice, as well as the two FDA documents, is scheduled for mid-July in the Federal Register. Comments should be submitted as directed in the addresses section of each document. Each document also provides information about how and where comments received may be viewed.
####
Note to Reporters: USDA news releases, program announcements and media advisories are available on the Internet. Go to the APHIS home page at www.aphis.usda.gov and click on the "News" button.
HHS news releases are available online at www.hhs.gov; FDA news releases can be found at www.fda.gov, which will also provide links to the documents discussed in this release.
####
http://www.fda.gov/bbs/topics/news/2004/NEW01084.html
STATEMENT BY LESTER M. CRAWFORD, D.V.M., PH.D. DEPUTY COMMISSIONER OF FOOD AND DRUGS DEPARTMENT OF HEALTH AND HUMAN SERVICES BEFORE THE COMMITTEE ON AGRICULTURE, NUTRITION, AND FORESTRY UNITED STATES SENATE JANUARY 27, 2004
Introduction
Mr. Chairman, Members of the Committee, thank you for the opportunity to participate in today’s hearing on measures taken by the Federal government to safeguard human and animal health in the United States from Bovine Spongiform Encephalopathy (BSE) and the response to the finding of a BSE-positive cow in the State of Washington. I am Dr. Lester M. Crawford, Deputy Commissioner, Food and Drug Administration (FDA or the Agency).
The mission of FDA is to protect the public health by assuring the safety and efficacy of our nation’s human and veterinary drugs, human biological products, medical devices, human and animal food supply, cosmetics, and radiation emitting products. In fulfilling this mission, FDA is the Agency responsible for assuring that all FDA-regulated products remain safe and uncompromised from BSE and related diseases. Many FDA-regulated products contain bovine ingredients, for example, heart valves, ophthalmic devices, dental products, wound dressings, injectable drugs, vaccines, soups, gravies, sausage casings, and animal feeds.
FDA has long been actively involved nationally and internationally in efforts to understand and prevent the spread of BSE. FDA collaborates extensively with the Centers for Disease Control and Prevention (CDC), the National Institutes of Health (NIH), the Animal and Plant Health Inspection Service (APHIS) and the Food Safety and Inspection Service (FSIS) within the U.S. Department of Agriculture (USDA), Customs and Border Protection (CBP), the Environmental Protection Agency (EPA), other Federal agencies, state and local jurisdictions, and with affected industries and consumer groups. Many of these activities fit within the framework of the Department of Health and Human Service’s (HHS or the Department) Bovine Spongiform Encephalopathy/Transmissible Spongiform Encephalopathy (BSE/TSE) Action Plan, which was released in August 2001. This collaboration over many years has enabled FDA to strengthen safeguards for FDA-regulated products and to respond quickly and effectively to the first case of BSE within the U.S.
Executive Summary
The mission of the Agency is to protect the public health by assuring the safety and efficacy of our nation’s human and veterinary drugs, human biological products, medical devices, human and animal food supply, cosmetics, and radiation emitting products. In fulfilling this mission, FDA is the Agency responsible for assuring that all FDA-regulated products remain safe and uncompromised from BSE and related diseases.
BSE is a progressive neurological disorder of cattle that results from infection by an unconventional transmissible agent, and was first diagnosed in the United Kingdom (U.K.) in 1986. Many FDA-regulated products contain bovine ingredients, for example, heart valves, ophthalmic devices, dental products, wound dressings, injectable drugs, vaccines, soups, gravies, sausage casings, and animal feeds and thus must be taken into consideration as part the effort to prevent infectivity by BSE.
FDA has a longstanding commitment to protecting consumers from BSE by following multiple measures designed to safeguard FDA-regulated products from possible contamination by the BSE agent. Under the Federal Food, Drug, and Cosmetic (FD&C) Act, FDA has the authority to prevent the adulteration and misbranding of FDA-regulated products. Further, for medical products that require pre-market approval (e.g., drugs under Section 505 and medical devices under Section 513 of the FD&C Act), FDA has addressed safety concerns related to BSE through requirements of the application and approval process.
The U.S. employs a robust multi-layered approach to preventing the introduction and amplification of BSE. While the goal of this approach is to achieve an extremely high level of compliance with each preventative measure, this multi-layered approach is designed to protect the U.S. consumer from exposure to the BSE infective material, and to date this approach has been working. Since 1989, USDA has prohibited the importation of live animals and animal products from BSE-positive countries. Since 1997, FDA has prohibited the use of certain mammalian proteins in the manufacture of ruminant feed. FDA continues to implement policies to keep safe all FDA-regulated products, including food, food ingredients, dietary supplements, drugs, vaccines, and cosmetics from risk of any BSE-contaminated bovine material. As a result of these multiple regulatory safeguards, the risk of exposure to BSE through products, FDA regulates remains extremely low in the U.S.
FDA’s 1997 animal feed regulation forms the basis of the Agency’s efforts to prevent the spread of BSE through animal feed. This rule prohibits the use of most mammalian protein in the manufacture of animal feeds for ruminants. FDA implemented this rule to establish in our country feeding practices consistent with the best science and epidemiological knowledge known at the time to prevent the spread of BSE throughout herds of U.S. cattle. A risk assessment sponsored by USDA and conducted by the Harvard Center for Risk Analysis, released in November 2001, identified FDA’s feed ban as one of the primary safeguards against the spread of BSE in U.S. cattle.
To maximize protection afforded by the feed regulation, FDA has developed and implemented a BSE/Ruminant Feed Ban Inspection compliance program and established the goal of 100 percent compliance. FDA’s strategy for achieving uniform compliance with the feed rule focuses on three areas: education, inspection, and enforcement. FDA and its state counterparts conduct, at least annually, targeted BSE inspections of 100 percent of known renderers, protein blenders, and feed mills processing products containing material prohibited from use in ruminant feed. Compliance by these establishments with FDA’s feed rule is estimated to be at better than 99 percent. As of December 20, 2003, FDA had received over 26,000 inspection reports (6,404 for Fiscal Year 2003). The majority of these inspections (around 70 percent) were conducted by state officials for FDA, with the remainder conducted by FDA officials. The total number of inspection reports represents 13,672 firms, 1,949 of which are active and handle materials prohibited from use in ruminant feed. The 1,949 active firms that handle prohibited material have been inspected by FDA and, as of December 31, 2003, only five were found to have significant violations, resulting in official action indicated (OAI). FDA is working with these firms to bring them into compliance.
On December 23, 2003, FDA was notified by USDA of a presumptive-positive finding of BSE in a cow in Washington State. FDA immediately initiated its BSE Emergency Response Plan. As part of the plan, FDA has been coordinately closely with USDA so that we can effectively investigate this BSE case, trace the various products involved, and take the appropriate steps to protect the public. FDA investigators and inspectors located the high risk material rendered from the infected cow, and the rendering plants placed a hold on the rendered material, which is being disposed of appropriately. I am happy to report that all of the establishments inspected by FDA during the course of the investigation were in compliance with the feed ban. In addition, to help address the concerns of foreign governments and restore confidence in American products, FDA has participated, along with USDA, in numerous meetings and consultations with foreign governments since USDA surveillance found the BSE-positive cow.
In addition to new policies and regulations, new knowledge and tools gained through applied research can greatly help us to be more effective in our regulatory mission, such as protecting the country from BSE. Several of FDA’s Centers, as well as many private laboratories, academic institutions, and other Federal agencies (most notably NIH) are also involved in significant research activities relating to TSEs. Basic areas requiring research include: increasing our understanding of prions, learning how prions are transmitted within a species and potentially between species, developing diagnostic tests for humans and animals, developing detection methods for use on regulated products, developing methods to increase or eliminate infectivity, and designing new treatments. We are optimistic about the promise of new technologies, such as better methods to quickly distinguish the species of proteins and sensors to detect abnormal prions in food. Development of these technologies can contribute significantly to the effort to prevent the spread of BSE and must be considered carefully when evaluating potential regulatory changes to address BSE.
At the time that FDA implemented the feed rule in 1997, the Agency also recognized that evolving, complex scientific and public health issues, particularly regarding BSE required the Agency to continue to assess and scrutinize the rule to ensure its integrity as a firewall against the potential for spread of BSE. To further explore ways the animal feed regulation could be improved in November 2002, FDA published an advance notice of proposed rulemaking (ANPR) soliciting information and views from the affected industries and the public on some potential changes to its current feed regulation, including ways that the animal feed regulation could be strengthened. Although the risk of exposure to BSE in the U.S. remains extremely low and the measures in place are working, as a result of the recently discovered infected cow in the state of Washington, the Agency is evaluating the appropriateness of additional science-based measures to further strengthen our current protections.
Yesterday, Department Secretary Tommy Thompson and FDA Commissioner Mark McClellan announced several additional public health measures to further strengthen the current robust safeguards that help protect Americans from exposure to the agent that causes BSE and help prevent the spread of BSE in U.S. cattle. These measures relate to both protections for foods intended for human consumption as well as additional measures to strengthen FDA’s 1997 final rule regulating animal feed. With respect to human foods, FDA announced that it will extend to FDA-regulated foods, dietary supplements and cosmetics, restrictions on using specified risk materials that would complement the recent USDA announcements. Concerning animal feed, the Agency announced a series of measures designed to lower even further the risk that cattle will be purposefully or inadvertently fed “ruminant” proteins, including, eliminating an exemption in the feed rule that allows mammalian blood and blood products at slaughter to be fed to ruminants as a protein source; banning the use of “poultry litter” as a feed ingredient for cattle and other ruminants; prohibiting the use of “plate waste” as a feed ingredient for ruminants, including cattle; and taking steps to further minimize the possibility of cross-contamination of animal feed via equipment, facilities or production lines.
Finally, FDA is increasing its inspections of feed mills and renderers in 2004. Our 2001 base funding for BSE-related activities was $3.8 million. We shifted resources internally in 2001 and received a substantial increase from Congress in 2002. Our funded level for 2004 is currently approximately $21.5 million, almost a five-fold increase over the 2001 base. FDA will itself conduct 2,800 inspections and will make its resources go even further by working with state agencies to fund 3,100 contract inspections of feed mills and renderers and other firms that handle animal feed and feed ingredients. Through partnerships with states, FDA will also receive data on 700 additional inspections, for a total of 3,800 state contract and partnership inspections in 2004. These inspections would include 100 percent of all known renderers and feed mills that process products containing prohibited materials.
The Agency looks forward to continuing to assist Congress as it evaluates the risks associated with BSE, identifies opportunities to promote technologies that will detect and prevent the spread of BSE, and considers science-based approaches to further strengthen regulatory protections and bolster the resources available to assist Federal, state, local and private efforts to assure that BSE does not present a threat to human or animal health in the U.S.
see full text ;
http://madcowfeed.blogspot.com/2008/04/substances-prohibited-from-use-in.html
OH, that's right, old lester sold out to the highest bidder $$$
Ex-FDA Chief Faces Fines in Stock Case By ANDREW BRIDGES, Associated Press Writer 1:55 PM PST, January 19, 2007
SNIP...SEE FULL TEXT ;
http://madcowfeed.blogspot.com/2009/04/docket-no-fda2002n0031-formerly-docket.html
WHAT MAD COW FEED BAN, THE 1997 FEED BAN WAS NOTHING BUT INK ON PAPER ;
10,000,000+ LBS. of PROHIBITED BANNED MAD COW FEED I.E. BLOOD LACED MBM IN COMMERCE USA 2007
Date: March 21, 2007 at 2:27 pm PST
RECALLS AND FIELD CORRECTIONS: VETERINARY MEDICINES -- CLASS II
___________________________________
PRODUCT
Bulk cattle feed made with recalled Darling's 85% Blood Meal, Flash Dried, Recall # V-024-2007
CODE
Cattle feed delivered between 01/12/2007 and 01/26/2007
RECALLING FIRM/MANUFACTURER
Pfeiffer, Arno, Inc, Greenbush, WI. by conversation on February 5, 2007.
Firm initiated recall is ongoing.
REASON
Blood meal used to make cattle feed was recalled because it was cross- contaminated with prohibited bovine meat and bone meal that had been manufactured on common equipment and labeling did not bear cautionary BSE statement.
VOLUME OF PRODUCT IN COMMERCE
42,090 lbs.
DISTRIBUTION
WI
___________________________________
PRODUCT
Custom dairy premix products: MNM ALL PURPOSE Pellet, HILLSIDE/CDL Prot- Buffer Meal, LEE, M.-CLOSE UP PX Pellet, HIGH DESERT/ GHC LACT Meal, TATARKA, M CUST PROT Meal, SUNRIDGE/CDL PROTEIN Blend, LOURENZO, K PVM DAIRY Meal, DOUBLE B DAIRY/GHC LAC Mineral, WEST PIONT/GHC CLOSEUP Mineral, WEST POINT/GHC LACT Meal, JENKS, J/COMPASS PROTEIN Meal, COPPINI - 8# SPECIAL DAIRY Mix, GULICK, L-LACT Meal (Bulk), TRIPLE J - PROTEIN/LACTATION, ROCK CREEK/GHC MILK Mineral, BETTENCOURT/GHC S.SIDE MK-MN, BETTENCOURT #1/GHC MILK MINR, V&C DAIRY/GHC LACT Meal, VEENSTRA, F/GHC LACT Meal, SMUTNY, A- BYPASS ML W/SMARTA, Recall # V-025-2007
CODE
The firm does not utilize a code - only shipping documentation with commodity and weights identified.
RECALLING FIRM/MANUFACTURER
Rangen, Inc, Buhl, ID, by letters on February 13 and 14, 2007. Firm initiated recall is complete.
REASON
Products manufactured from bulk feed containing blood meal that was cross contaminated with prohibited meat and bone meal and the labeling did not bear cautionary BSE statement.
VOLUME OF PRODUCT IN COMMERCE
9,997,976 lbs.
DISTRIBUTION
ID and NV
END OF ENFORCEMENT REPORT FOR MARCH 21, 2007
http://www.fda.gov/bbs/topics/enforce/2007/ENF00996.html
NEW URL
http://www.fda.gov/Safety/Recalls/EnforcementReports/2007/ucm120446.htm
Thursday, March 19, 2009 MILLIONS AND MILLIONS OF POUNDS OF MAD COW FEED IN COMMERCE USA WITH ONGOING 12 YEARS OF DENIAL NOW, WHY IN THE WORLD DO WE TO TALK ABOUT THIS ANYMORE $$$
http://madcowfeed.blogspot.com/2009/03/millions-and-millions-of-pounds-of-mad.html
Judge rules poultry-litter fertilizer is solid waste
By CURTIS KILLMAN World Staff Writer Published: 8/15/2009 2:25 AM Last Modified: 8/15/2009 3:37 AM
Poultry companies on Friday lost a bid to have part of the state's Illinois River watershed pollution lawsuit dismissed by claiming that poultry litter wasn't solid waste.
U.S. District Judge Gregory Frizzell ruled that poultry litter, a mixture of poultry waste and bedding material, may be considered a solid waste if it is applied in excessive amounts on fields as fertilizer.
"Today's ruling is important in that it demonstrates that the defendants can be held responsible for the over-application runoff and leaching that endangers human health and the environment," Charlie Price, a spokesman for Attorney General Drew Edmondson, said in an e-mail.
The ruling came amid a series of challenges fielded by Frizzell on Thursday and Friday, just prior to a scheduled Sept. 21 trial date.
The state, led by Edmondson, is suing 12 poultry companies, claiming that they are legally responsible for the handling and disposal of poultry waste that has damaged portions of the Illinois River watershed in Oklahoma.
The state has claimed that poultry waste is a solid waste and thus subject to federal law barring illegal disposal.
The poultry industry challenged the use of that federal law, claiming that poultry litter was not a solid waste.
"Poultry litter is a widely utilized fertilizer, which provides soil nutrients, increases crop yields and outperforms commercial fertilizers," attorneys for the poultry industry wrote in a court filing.
In another ruling, the poultry
companies lost a bid to revoke a settlement agreement between another poultry company and the state.
Frizzell ruled a settlement agreement involving Willow Brook Foods Inc. and the state was fair and reasonable. Willow Brook was originally included in a group of 13 poultry companies sued by the state in the pollution case.
The remaining 12 poultry companies had objected to the settlement agreement after it was announced in May.
The agreement called for Willow Brook Foods, now called Cold Zone Inc., to pay $120,000 as part of a deal to settle claims made by the state in the pollution case.
Frank Evans, an attorney for Willow Brook Foods, said while the $120,000 may not be a lot of money for other poultry companies named in the lawsuit, "I can assure you it is a very large amount of money for my client."
In other matters, Frizzell heard a request from the state to reconsider his ruling that the state could not pursue damages totaling more than $600 million. In July, the judge said the state could not pursue damages because it failed to properly include the Cherokee Nation in the lawsuit.
Frizzell said he would rule later on the reconsideration request
http://www.tulsaworld.com/news/article.aspx?subjectid=14&articleid=20090815_11_A1_Poultr953527&allcom=1
LETS see now, the one mad cow that was covered up for 7+ months due to the MRR policy being born, then finally, after an act of Congress, confirmed by England, then the other highly suspect mad cow in Texas that was never, ever tested, just wisk away to be rendered, and the other suspect mad cow that tissue samples sat around for another 4 months, for the same reaseon as the 7+ month suspect and later confirmed mad cow (MRR being born, could not have no mad cows before that policy was in effect). see history below ;
Tuesday, July 14, 2009
U.S. Emergency Bovine Spongiform Encephalopathy Response Plan Summary and BSE Red Book Date: February 14, 2000 at 8:56 am PST
WHERE did we go wrong $$$
http://madcowtesting.blogspot.com/2009/07/us-emergency-bovine-spongiform.html
Transgenic mice expressing porcine prion protein resistant to classical scrapie but susceptible to sheep bovine spongiform encephalopathy and atypical scrapie. Emerg Infect Dis. 2009 Aug; [Epub ahead of print]
http://nor-98.blogspot.com/2009/07/transgenic-mice-expressing-porcine.html
Transmissible mink encephalopathy - review of the etiology
http://transmissible-mink-encephalopathy.blogspot.com/2009/07/transmissible-mink-encephalopathy.html
Wednesday, July 1, 2009
Nor98 scrapie identified in the United States J Vet Diagn Invest 21:454-463 (2009)
http://nor-98.blogspot.com/2009/07/nor98-scrapie-identified-in-united.html
Wednesday, August 05, 2009 Rate of CWD infection increases in core area WISCONSIN
http://chronic-wasting-disease.blogspot.com/2009/08/rate-of-cwd-infection-increases-in-core.html
Monday, June 01, 2009 Biochemical typing of pathological prion protein in aging cattle with BSE
SOMETHING TO PONDER ???
O.K. confusious asks, IF all these new atypical BSEs i.e. new strains of mad cow disease is just an 'OLD COW PRION DISEASE', why then can not the 'old human prion disease' such as the sporadic CJD, be from an 'old cow prion disease', same as the nvCJD 'young people mad cow disease' (which also happens in 74 year old), but why cannot the 'old cow prion diseases', i.e. l-BSE, h-BSE, and ibncBSE, cause the 'old people prion disease', which looks like sporadic CJD. seems that is what some of the pathology is showing ???
OH, that probably makes too much sense, and that the only answer could be that it's all just a happenstance of bad luck and or a spontaneous event, that just happens out of the clear blue sky $$$
IF this is the case, then where are all the SPONTANEOUS BSE CASES OF MAD COW DISEASE IN THE U.S.A., AND WHERE HAVE THEY BEEN BURIED IN THE USA OVER THE LAST 25 YEARS ???
http://bse-atypical.blogspot.com/2009/06/biochemical-typing-of-pathological.html
Atypical BSE North America Update February 2009
http://bse-atypical.blogspot.com/2009/02/atypical-bse-north-america-update.html
Tuesday, August 11, 2009
Characteristics of Established and Proposed Sporadic Creutzfeldt-Jakob Disease Variants
http://creutzfeldt-jakob-disease.blogspot.com/2009/08/characteristics-of-established-and.html
Sunday, August 09, 2009
CJD...Straight talk with...James Ironside...and...Terry Singeltary... 2009
http://creutzfeldt-jakob-disease.blogspot.com/2009/08/cjdstraight-talk-withjames.html
Monday, July 27, 2009
U.S.A. HIDING MAD COW DISEASE VICTIMS AS SPORADIC CJD ?
WHY DID THIS VIDEO NOT SHOW ON EVERY NEWS CHANNEL IN THE U.S.A. $$$
IT IS A DAMNING VIDEO !!!
I WATCHED THIS RECENTLY, and had never seen it. i was so mad, i was spitting nails out faster than a framing gun.
WHY DID THE CANADIAN MEDIA ONLY PRESENT THIS TO THE U.S.A. PUBLIC (thank you very much though), and why has the U.S.A. MEDIA FAILED US ???
WHY DID R-CALF NOT SHOW THIS ??? where was r-calf when you needed them back then $$$
SNIP...
Monday, July 27, 2009
U.S.A. HIDING MAD COW DISEASE VICTIMS AS SPORADIC CJD ?
http://creutzfeldt-jakob-disease.blogspot.com/2009/07/usa-hiding-mad-cow-disease-victims-as.html
Docket APHIS-2006-0026 Docket Title Bovine Spongiform Encephalopathy; Animal Identification and Importation of Commodities Docket Type Rulemaking Document APHIS-2006-0026-0001 Document Title Bovine Spongiform Encephalopathy; Minimal-Risk Regions, Identification of Ruminants and Processing and Importation of Commodities Public Submission APHIS-2006-0026-0012 Public Submission Title Comment from Terry S Singletary
http://www.regulations.gov/fdmspublic/component/main?main=DocumentDetail&o=09000064801e47e1
Docket APHIS-2006-0041 Docket Title Bovine Spongiform Encephalopathy; Minimal-Risk Regions; Importation of Live Bovines and Products Derived from Bovines Commodities Docket Type Rulemaking Document APHIS-2006-0041-0001 Document Title Bovine Spongiform Encephalopathy; Minimal-Risk Regions; Importation of Live Bovines and Products Derived From Bovines Public Submission APHIS-2006-0041-0028 Public Submission Title Comment from Terry S Singletary
Comment 2006-2007 USA AND OIE POISONING GLOBE WITH BSE MRR POLICY
THE USA is in a most unique situation, one of unknown circumstances with human and animal TSE. THE USA has the most documented TSE in different species to date, with substrains growing in those species (BSE/BASE in cattle and CWD in deer and elk, there is evidence here with different strains), and we know that sheep scrapie has over 20 strains of the typical scrapie with atypical scrapie documented and also BSE is very likely to have passed to sheep. all of which have been rendered and fed back to animals for human and animal consumption, a frightening scenario. WE do not know the outcome, and to play with human life around the globe with the very likely TSE tainted products from the USA, in my opinion is like playing Russian roulette, of long duration, with potential long and enduring consequences, of which once done, cannot be undone. These are the facts as I have come to know through daily and extensive research of TSE over 9 years, since 12/14/97. I do not pretend to have all the answers, but i do know to continue to believe in the ukbsenvcjd only theory of transmission to humans of only this one strain from only this one TSE from only this one part of the globe, will only lead to further failures, and needless exposure to humans from all strains of TSE, and possibly many more needless deaths from TSE via a multitude of proven routes and sources via many studies with primates and rodents and other species.
MY personal belief, since you ask, is that not only the Canadian border, but the USA border, and the Mexican border should be sealed up tighter than a drum for exporting there TSE tainted products, until a validated, 100% sensitive test is available, and all animals for human and animal consumption are tested. all we are doing is the exact same thing the UK did with there mad cow poisoning when they exported it all over the globe, all the while knowing what they were doing. this BSE MRR policy is nothing more than a legal tool to do just exactly what the UK did, thanks to the OIE and GW, it's legal now. and they executed Saddam for poisoning ???
go figure. ...
http://www.regulations.gov/fdmspublic/component/main?main=DocumentDetail&o=09000064801f8151
Docket APHIS-2006-0041 Docket Title Bovine Spongiform Encephalopathy; Minimal-Risk Regions; Importation of Live Bovines and Products Derived from Bovines Commodities Docket Type Rulemaking Document APHIS-2006-0041-0001 Document Title Bovine Spongiform Encephalopathy; Minimal-Risk Regions; Importation of Live Bovines and Products Derived From Bovines Public Submission APHIS-2006-0041-0028.1 Public Submission Title Attachment to Singletary comment
January 28, 2007
Greetings APHIS,
I would kindly like to submit the following to ;
BSE; MRR; IMPORTATION OF LIVE BOVINES AND PRODUCTS DERIVED FROM BOVINES [Docket No. APHIS-2006-0041] RIN 0579-AC01
http://www.regulations.gov/fdmspublic/ContentViewer?objectId=09000064801f8152&disposition=attachment&contentType=msw8
Thursday, April 9, 2009
Docket No. FDA2002N0031 (formerly Docket No. 2002N0273) RIN 0910AF46 Substances Prohibited From Use in Animal Food or Feed; Final Rule: Proposed
http://madcowfeed.blogspot.com/2009/04/docket-no-fda2002n0031-formerly-docket.html
IN A NUT SHELL ; $$$
(Adopted by the International Committee of the OIE on 23 May 2006)
11. Information published by the OIE is derived from appropriate declarations made by the official Veterinary Services of Member Countries.The OIE is not responsible for inaccurate publication of country disease status based on inaccurate information or changes in epidemiological status or other significant events that were not promptly reported to then Central Bureau............
http://www.oie.int/eng/Session2007/RF2006.pdf
PAUL BROWN COMMENT TO ME ON THIS ISSUE
Tuesday, September 12, 2006 11:10 AM
"Actually, Terry, I have been critical of the USDA handling of the mad cow issue for some years, and with Linda Detwiler and others sent lengthy detailed critiques and recommendations to both the USDA and the Canadian Food Agency."
http://lists.ifas.ufl.edu/cgi-bin/wa.exe?A2=ind0703&L=sanet-mg&T=0&P=8125
http://bse-atypical.blogspot.com/2009/02/atypical-bse-north-america-update.html
The logic behind the reasons not to let test for TSE in the USA because of The Virus Serum Toxin Act of 1913 and or because of the recent letter from the USAHA (see letter below) bring forth, are totally bogus. NO one could screw the testing up any worse than the USDA has done in the past. The OIG and the GAO has shown this time and time again. The 2004 Enhanced BSE surveillance program where some 275,000+ cattle were tested for BSE was proven to be terribly flawed from the beginning. This documented time and time again. Even Paul Brown, known and respected TSE scientist, former TSE expert for the CDC said he had ''absolutely no confidence in USDA tests before one year ago'', and this was on March 15, 2006 ;
"The fact the Texas cow showed up fairly clearly implied the existence of other undetected cases," Dr. Paul Brown, former medical director of the National Institutes of Health's Laboratory for Central Nervous System Studies and an expert on mad cow-like diseases, told United Press International. "The question was, 'How many?' and we still can't answer that."
Brown, who is preparing a scientific paper based on the latest two mad cow cases to estimate the maximum number of infected cows that occurred in the United States, said he has "absolutely no confidence in USDA tests before one year ago" because of the agency's reluctance to retest the Texas cow that initially tested positive.
USDA officials finally retested the cow and confirmed it was infected seven months later, but only at the insistence of the agency's inspector general.
"Everything they did on the Texas cow makes everything USDA did before 2005 suspect," Brown said. ...snip...end
http://www.upi.com/
CDC - Bovine Spongiform Encephalopathy and Variant Creutzfeldt ... Dr. Paul Brown is Senior Research Scientist in the Laboratory of Central Nervous System ... Address for correspondence: Paul Brown, Building 36, Room 4A-05, ...
http://www.cdc.gov/ncidod/eid/vol7no1/brown.htm
Sunday, April 12, 2009
r-calf and the USA mad cow problem, don't look, don't find, and then blame Canada
http://prionunitusaupdate2008.blogspot.com/2009/04/r-calf-and-usa-mad-cow-problem-dont.html
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