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
Showing posts with label UPDATE 2009. Show all posts
Showing posts with label UPDATE 2009. Show all posts
Thursday, August 27, 2009
Saturday, June 13, 2009
BSE FEED VIOLATIONS USA UPDATE From 01/01/2009 To 06/10/2009
Subject: BSE FEED VIOLATIONS UPDATE From 01/01/2009 To 06/10/2009
FDA BSE/Ruminant Feed Inspections Firms Inventory Report
Data reported as of: 06/06/2009 Search by: Last BSE Insp Date From 01/01/2009 To 06/10/2009 Sort by: FDA District, State, Firm Name
FDA District Firm Id (FEI) Firm Name Street Address City State Zip Code Opr. Status Firm Type(s) Prgm Risk Last BSE Insp Date Last BSE Dist. Dcsn** Handles Feed for Rum. Animals?
DAL-DO 3007064862 Mars Petcare US #1 Mars Road Clinton OK 73601 OPR PF HP 05/28/2009 OAI Y
ATL-DO 3007582627 Hoffner Brothers Dairy 610 Ketchie Rd Mount Ulla NC 28125-9685 OPR FR, OF, OT NP 02/03/2009 VAI Y
CIN-DO 3002766655 Lester J Stutzman Feed Mill 2811 Mt Zion Rd Marion KY 42064 OPR DR, FR, NL, OF DP 01/05/2009 VAI Y
CIN-DO 3003407434 Direct Action Co Inc 6668 Old SR 39 NW Dover OH 44622 OPR DR, NL, OT HP 05/04/2009 VAI Y
KAN-DO 1000050408 Mid-South Milling Co Inc 213 Central Ave Kansas City KS 66118-1117 OPR OT, PB, TH HP 01/14/2009 VAI N
KAN-DO 3007495971 Midwest Bulk Inc 3404 N Emporia St Wichita KS 67219-3615 OPR TH DP 02/26/2009 VAI Y
KAN-DO 3007458821 Murray Grain Co Inc 900 E 21st St N Ste 201 Wichita KS 67214-1406 OPR TH DP 02/26/2009 VAI Y
KAN-DO 3006292356 Orscheln Farm & Home 1702 W 11th St Coffeyville KS 67337-3115 OPR DR DP 02/02/2009 VAI Y
LOS-DO 2027094 Nestle, USA/ Nestle Prepared Foods Company 9601 Canoga Ave Chatsworth CA 91311-4115 OPR HF HP 05/26/2009 VAI N
NYK-DO 1310558 Birkett Mills 1 Main St Penn Yan NY 14527-1615 OPR DR, HF, NL NP 01/11/2009 RTS Y
Data reported as of: 06/06/2009 Search by: Last BSE Insp Date From 01/01/2003 To 06/10/2009 and Last BSE District Decision = OAI Sort by: FDA District, State, Firm Name
FDA District Firm Id (FEI) Firm Name Street Address City State Zip Code Opr. Status Firm Type(s) Prgm Risk Last BSE Insp Date Last BSE Dist. Dcsn** Handles Feed for Rum. Animals?
KAN-DO 1927975 Hahn & Phillips Grease Co Inc 913 N Odell, PO Box 130 Marshall MO 65340 OPR NL, PB, TH HP 12/22/2008 OAI Y
Legend - Opr.Status:OPR=Operational, SEA=Seasonal, PRP=Pre-Production, Firm Type: AF=Animal Feed/Pet Food Salvager, DR=Distributor/Retailer, FL=Feed Mill (FDA Licensed), FR=Feeder of Ruminants, HF=Human Food Processor, NL=Feed Mill (not FDA Licensed), OF=On-farm Feed Mixer, OT=Other, PB=Protein Blender, PF=Pet Food Manufacturer, RE=Renderer, RO=Feeder of Ruminants and Other Species, TH=Transporter (Hauler), Prgm Risk:DP=Only Distributes Prohib.Mat.(DP), HP=Handles Prohibited Materials(HP), NP=Does not handle Prohib.Mat.(NP), Dist Dcsn:OAI=Official Action Indicated (OAI), VAI=Voluntary Action Indicated (VAI), NAI=No Action Indicated (NAI), RTS=Referred to State (RTS),
http://www.accessdata.fda.gov/BSEInspect/bse_excel.jsp
February 6, 2004
To help prevent the establishment and amplification of BSE through feed in the United States, FDA implemented a final rule that prohibits the use of most mammalian protein in feeds for ruminant animals. This rule, Title 21 Part 589.2000 of the Code of Federal Regulations, became effective on August 4, 1997.
This is an update on FDA enforcement activities regarding the ruminant feed (BSE) regulation. FDA's CVM has assembled data from the inspections that have been conducted AND whose final inspection report has been recorded in the FDA's inspection database as of January 23, 2004. As of January 23, 2004, FDA had received over 26,000 inspection reports. The majority of these inspections (around 70%) were conducted by State officials under contract to FDA, with the remainder conducted by FDA officials.
Inspections conducted by FDA or State investigators are classified to reflect the compliance status at the time of the inspection based upon the objectionable conditions documented. These inspection conclusions are reported as Official Action Indicated (OAI), Voluntary Action Indicated (VAI), or No Action Indicated (NAI).
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
A VAI inspection classification occurs when objectionable conditions or practices were found that do not meet the threshold of regulatory significance, but do warrant advisory actions to inform the establishment of findings that should be voluntarily corrected. Inspections classified with VAI violations are more technical violations of Title 21 Part 589.2000 of the Code of Federal Regulations, (here called the Ruminant Feed Ban) became effective on August 4, 1997. Ruminant Feed Ban provisions such as minor recordkeeping lapses and conditions involving non-ruminant feeds.
A NAI inspection classification occurs when no objectionable conditions or practices were found during the inspection or the significance of the documented objectionable conditions found does not justify further actions.
The results to date are reported here both by “segment of industry” and “in total”. NOTE – A single firm can operate as more than one firm type. As a result, the categories of the different industry segments are not mutually exclusive.
http://www.fda.gov/AnimalVeterinary/NewsEvents/CVMUpdates/ucm048448.htm
Greetings,
THERE were 100s of NAI's, but you get the just. also, please note ;
>>>A VAI inspection classification occurs when objectionable conditions or practices were found that do not meet the threshold of regulatory significance, but do warrant advisory actions to inform the establishment of findings that should be voluntarily corrected. Inspections classified with VAI violations are more technical violations of Title 21 Part 589.2000 of the Code of Federal Regulations, (here called the Ruminant Feed Ban) became effective on August 4, 1997. Ruminant Feed Ban provisions such as minor recordkeeping lapses and conditions involving non-ruminant feeds.<<< href="http://www.fda.gov/foi/warning_letters/g4849d.htm">http://www.fda.gov/foi/warning_letters/g4849d.htm
Public Health Service Food and Drug Administration
Chicago District 550 West Jackson Blvd., 15th Floor Chicago, Illinois 60661 Telephone: 312-353-5863
July 12, 2004
WARNING LETTER CHI-16-04
CERTIFIED MAIL RETURN RECEIPT REQUESTED
Mr. Donald E. Hamilton, President/Owner Illini Feeds, Inc. P.O. Box 86, 1145 State Hwy. 94 Aledo, Illinois 61231
Dear Mr. Hamilton:
On February 19 and 20, 2004, the Food and Drug Administration (FDA) conducted an inspection of your animal feed handling facility located at 1145 State Highway 94, Aledo, Illinois. The inspection found significant deviations from the requirements set forth in Title 21, Code of Federal Regulations, Part 589.2000 (21 CFR 589.2000) - Animal Proteins Prohibited in Ruminant Feed. This regulation is intended to prevent the establishment and amplification of Bovine Spongiform Encephalopathy (BSE). The deviations cause the swine feed manufactured by your facility to be misbranded within the meaning of Section 403(a)(1) of the Federal Food, Drug, and Cosmetic Act (the Act).
Our investigation found that salvaged pet food containing prohibited material was added as an ingredient to the swine products manufactured at your facility. During the inspection, our investigator found that you failed to label your non-ruminant products with the required caution statement - Do not feed to cattle or other ruminants. [21 CFR 589.2000(d)(1)]
The above is not intended to be an all-inclusive list of violations. As a manufacturer of materials intended for use in animal feed, you are responsible for assuring that your overall operation and the products you manufacture and distribute are in compliance with the law.
You should take prompt action to correct this violation, and you should establish a system whereby such violations do not recur. Failure to promptly correct this violation may result in regulatory action without further notice, such as seizure and/or injunction.
During the inspection, you told the investigator that you would put the required cautionary statement on your products that contain prohibited material, and maintain tracking documents for all incoming ingredients, including animal proteins prohibited in ruminant feed. Please notify this office in writing within 15 working days of receiving this letter of any further steps you have taken to assure that your firm is in compliance with the law. Your response should also include an explanation of each step taken to correct the violations, and prevent their recurrence. Please include copies of any available documentation such as written procedures, corrected labeling, etc., demonstrating that corrections have been made. If corrections cannot be completed within 15 working days, state the reason for the delay and the date by which the corrections will be completed.
Your reply should be directed to Paul A. Boehmer, Compliance Officer, at the above address.
Sincerely,
/s/
Scott J. MacIntire District Director
http://www.fda.gov/foi/warning_letters/g4840d.htm
Public Health Service Food and Drug Administration
Chicago District 550 West Jackson Blvd., 15th Floor Chicago, Illinois 60661 Telephone: 312-353-5863
June 15, 2004
WARNING LETTER
CERTIFIED MAIL RETURN RECEIPT REQUESTED
Mr. David W. Bernauer CEO and Chairman of the Board Walgreen co. 200 Wilmot Rd. Deerfield, IL 60015
Dear Mr. Bernauer:
Inspection of your firms warehouse at 5100 Lake Terrace N.E., Mt. Vernon, Illinois, by the Illinois Department of Public Health and the U.S. Food and Drug Administration (FDA) on February 25, 26, and 27, and March 2, 2004, documented numerous insanitary conditions which caused the food and drug products stored there to become adulterated.
Our inspection showed that the food and drug products stored and held at your facility violated the Federal Food, Drug, and Cosmetic Act (the Act), rendering them adulterated. These adulterated fwd and drug products: a) consisted in whole or in part of filthy substances, including rodent fecal pellets, rodent hair, and insects, in violation of Section 402(a)(3) of the Act [21 U.S.C. 342(a)(3)]; and/or b) had been held under insanitary conditions whereby they have become contaminated with rodent filth, in violation of Sections 402(a)(4) and 501(a)(2)(a) of the Act [21 U.S.C. 342(a)(4), 351(a)(2)(a)].
Evidence of rodent activity documented throughout the old and new warehouse included dead mice in traps, excreta pellets, and gnawed paper material observed in, on, and near food and drugs stored in the warehouse. Rodents gnaw holes were observed into several packaged food products with rodent hairs at gnaw holes into products. Many more fecal pellets were on food and drug packages and still more were found near the stored foods, drugs, and cosmetics in the warehouse.
Other conditions observed during the inspection that could be contributing factors to rodent infestation include damaged and/or poorly fitting rail and truck dock doors, gaps around a conduit entry into the building, and the structural condition of the concrete and expansion gaps at floor/wall/support beam junctions in various areas of the warehouse allowing the entry or harborage of pests. Additionally, the investigators observed cobwebs, dead insects, dust, debris, product spillage, and papers in the warehouse, indicating a general lack of good sanitation practices.
Also, products that contain or may contain animal protein prohibited ruminant feed (BSE material) failed to bear the caution statement, Do not feed to cattle or other ruminants. Specifically, pet food products were salvaged, repackaged, and donated to [redacted] and other similar organizations in the area, without the proper labeling and agreement that they would not be used for ruminants. Please refer to Title 21, Code of Federal Regulations, Section 589.2000, concerning these requirements.
Our laboratory confirmed the findings of rodent excreta, rodent hairs on product gnaw holes, and rodent gnawed fibers (packaging material) sampled from the warehouse during the inspection.
The above listed violations are not intended to be all-inclusive. It is your responsibility to assure adherence with each requirement of the Act and its implementing regulations. The investigators reported that you destroyed food products that showed evidence of contamination and began to take some steps to correct the insanitary conditions in your facility. We request that you take prompt action to correct all violations.
Please provide this office, within 15 working days of receipt of this letter, a detailed response stating the actions you plan to take and have taken to correct and prevent the recurrence of these objectionable conditions. Provide the time within which corrections will be completed, reasons why any corrective action cannot be completed, and documentation to show that corrections have been made. Failure to take prompt action to correct all violations may result in regulatory action without further notice. Such action includes seizure and/or injunction.
Your reply should be directed to Paul A. Boehmer, Compliance Officer, at the Chicago District Office.
Sincerely,
/s/
Scott J. MacIntire District Director
cc: Stephen J. Lawrence, Distribution Center Manager Walgreen Co. 5100 Lake Terrace NE Mount Vernon, IL 62864-9665
http://www.fda.gov/foi/warning_letters/g4853d.htm
USA BSE GBR SHOULD BE GBR III, but someone dropped the ball...
TSS
######### http://mailhost-alt.rz.uni-karlsruhe.de/warc/bse-l.html ##########
Department of Health and Human Services Public Health Service Food and Drug Administration
Minneapolis District Office Central Region 212 Third Avenue South Minneapolis, MN 55401 Telephone: (612) 758-7119 FAX: (612) 334-4142
June 9, 2005
WARNING LETTER
CERTIFIED MAIL RETURN RECEIPT REQUESTED
Refer to MIN 05-15
Michael J. Langenhorst President Anamax Corporation P.O. Box 10067 Green Bay, WI 54307
Dear Mr. Langenhorst:
Our inspection of your rendering plant located at 505 Hardman Avenue South, South St. Paul, Minnesota, from January 12-20, 2005, revealed significant deviations from the requirements set forth in Title 21, Code of Federal Regulations , Part 589 .2000 (21 CFR 589 .2000), Animal Proteins Prohibited in Ruminant Feed. This regulation is intended to prevent the establishment and amplification of Bovine Spongiform Encephalopathy (BSE). Because you failed to follow the requirements of this regulation, products being manufactured and distributed by your facility are adulterated within the meaning of Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. 342(a)(4)], and misbranded within the meaning of Section 403(a)(1) of the Act [21 U.S.C. 343(a)(1)].
Our investigation found that you failed to provide for measures to prevent commingling or cross-contamination and to maintain sufficient written procedures [21 CFR 589.2000(e)] in that:
1. You failed to use clean-out procedures or other means adequate to prevent carryover of protein derived from mammalian tissues into feeds that may be used for ruminants.
2. You failed to maintain written procedures specifying the clean-out procedures or other means to prevent carryover of protein derived from mammalian tissues into feeds that may be used for ruminants.
Our investigation also found that you failed to label products that may contain protein derived from mammalian tissues with the statement, "Do not feed to cattle or other ruminants." For example, your Feather Meal and Stabilized Poultry By-Product Meal lack this statement, even though the absence of sufficient measures to avoid commingling or cross-contamination may result in these products containing protein derived from mammalian tissues. Because your products do not bear this caution statement, they are misbranded under Section 403(a)(1) of the Act [21 U.S .C. 343(a)(1)).
The above is not intended as an all-inclusive list of violations. As a manufacturer of materials intended for animal feed use, you are responsible for ensuring that your overall operation and the products you manufacture and distribute are in compliance with the law.
You should acknowledge this letter within 15 working days of receiving and include any additional corrective actions concerning your facility. We have received your letter dated January 31, 2005, which replies to the Form FDA-483 issued on January 20, 2005, and your letter dated February 25, 2005, that states all corrections have been implemented. The corrections you have reported appear to be adequate but will be evaluated further during our follow-up inspection.
Your response should be directed to Compliance Officer Jane E . Nelson at the address on the letterhead. If you have any questions regarding this letter, you may phone Ms. Nelson at (612) 758-7119.
Sincerely,
/S/
W. Charles Becoat Director Minneapolis District
http://www.fda.gov/foi/warning_letters/g5373d.pdf
New Orleans District 297 Plus Park Blvd. Nashville, TN 37217
Telephone: 615-781-5380 Fax: 615-781-5391
May 17, 2006
WARNING LETTER NO. 2006-NOL-06
FEDERAL EXPRESS OVERNIGHT DELIVERY
Mr. William Shirley, Jr., Owner Louisiana.DBA Riegel By-Products 2621 State Street Dallas, Texas 75204
Dear Mr. Shirley:
On February 12, 17, 21, and 22, 2006, a U.S. Food & Drug Administration (FDA) investigator inspected your rendering plant, located at 509 Fortson Street, Shreveport, Louisiana. The inspection revealed significant deviations from the requirements set forth in Title 21, Code of Federal Regulations, Part 589.2000 [21 CFR 589.2000], Animal Proteins Prohibited in Ruminant Feed. This regulation is intended to prevent the establishment and amplification of Bovine Spongiform Encephalopathy (BSE). You failed to follow the requirements of this regulation; products being manufactured and distributed by your facility are misbranded within the meaning of Section 403(a)(1) [21 USC 343(a)(1)] of the Federal Food, Drug, and Cosmetic Act (the Act).
Our investigation found you failed to provide measures, including sufficient written procedures, to prevent commingling or cross-contamination and to maintain sufficient written procedures [21 CFR 589.2000(e)] because:
You failed to use clean-out procedures or other means adequate to prevent carryover of protein derived from mammalian tissues into animal protein or feeds which may be used for ruminants. For example, your facility uses the same equipment to process mammalian and poultry tissues. However, you use only hot water to clean the cookers between processing tissues from each species. You do not clean the auger, hammer mill, grinder, and spouts after processing mammalian tissues.
You failed to maintain written procedures specifying the clean-out procedures or other means to prevent carryover of protein derived from mammalian tissues into feeds which may be used for ruminants.
As a result . the poultry meal you manufacture may contain protein derived from mammalian tissues prohibited in ruminant feed. Pursuant to 21 CFR 589.2000(e)(1)(i), any products containing or may contain protein derived from mammalian tissues must be labeled, "Do not feed to cattle or other ruminants." Since you failed to label a product which may contain protein derived from mammalian tissues with the required cautionary statement. the poultry meal is misbranded under Section 403(a)(1) [21 USC 343(a)(1)] of the Act.
This letter is not intended as an all-inclusive list of violations at your facility. As a manufacturer of materials intended for animal feed use, you are responsible for ensuring your overall operation and the products you manufacture and distribute are in compliance with the law. You should take prompt action to correct these violations, and you should establish a system whereby violations do not recur. Failure to promptly correct these violations may result in regulatory action, such as seizure and/or injunction, without further notice.
You should notify this office in writing within 15 working days of receiving this letter, outlining the specific steps you have taken to bring your firm into compliance with the law. Your response should include an explanation of each step taken to correct the violations and prevent their recurrence. If corrective action cannot be completed within 15 working days, state the reason for the delay and the date by which the corrections will be completed. Include copies of any available documentation demonstrating corrections have been made.
Your reply should be directed to Mark W. Rivero, Compliance Officer, U.S. Food and Drug Administration, 2424 Edenborn Avenue, Suite 410, Metairie, Louisiana 70001. If you have questions regarding any issue in this letter, please contact Mr. Rivero at (504) 219-8818, extension 103.
Sincerely,
/S
Carol S. Sanchez Acting District Director New Orleans District
http://www.fda.gov/foi/warning_letters/g5883d.htm
now that's what i'm talken about. but those were shut down just after the
Date: Wed, 2 Oct 2002 09:04:42 -0700
Reply-To: Bovine Spongiform Encephalopathy
Sender: Bovine Spongiform Encephalopathy
From: Terry S. Singeltary Sr.
Subject: MAD COW FEED BAN WARNING LETTERS USA 'update' (where did
all Terry's MAD COW warning letters go?)
Docket Management Docket: 02N-0273 - Substances Prohibited From ...
http://www.fda.gov/ohrms/dockets/dailys/03/Jan03/012403/8004be07.html
>>> Mr. Singeltary is correct that Dr. Detwiler asked participants to use the FDA ...... oh where, did all Terry's mad cow feed ban warning letters go$ >> >>FDA ...
www.fda.gov/ohrms/dockets/dailys/03/Jan03/012403/8004be07.html -
Subject: MAD COW FEED BAN WARNING LETTERS USA 'update' (where did all Terry's MAD COW warning letters go?)
From: "Terry S. Singeltary Sr." <mhtml:%7B33B38F65-8D2E-434D-8F9B-8BDCD77D3066%7Dmid://00000064/!x-usc:mailto:flounder@WT.NET>
Reply-To: Bovine Spongiform Encephalopathy <mhtml:%7B33B38F65-8D2E-434D-8F9B-8BDCD77D3066%7Dmid://00000064/!x-usc:mailto:BSE-L@UNI-KARLSRUHE.DE>
Date: Wed, 2 Oct 2002 09:04:42 -0700 Content-Type: text/plain
where, oh where, did all Terry's mad cow feed ban warning letters go$
FDA Cuts Back on Warnings
10/01/02
WASHINGTON -- The Food and Drug Administration has substantially cut back on warnings sent to companies that run afoul of its rules, a move the agency contends will result in more-effective enforcement but that critics say lets violators off the hook.
The drop results from a policy change in late February that requires the FDA chief counsel's office to clear all warning letters to ensure they are legally sound. Before the change, division and district offices around the country issued such letters unilaterally. In the six months since, the agency issued 279 warning letters, a drop of 64% from the same period last year, a review of agency records shows. The FDA says the chief counsel's office rejected only 6% of the 699 warning letters and other citations it reviewed. At the same time, division and district enforcers may be holding back letters they once would have sent.
SEE FULL STORY
http://online.wsj.com/
snip...end
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
Wednesday, January 28, 2009
TAFS1 Position Paper on Specified Risk Materials (January, 2009) TAFS INTERNATIONAL FORUM FOR TRANSMISSIBLE ANIMAL DISEASES AND FOOD SAFETY a non-profit Swiss Foundation(January 2009)TAFS1 Position Paper on Specified Risk Materials
http://madcowspontaneousnot.blogspot.com/2009/01/tafs1-position-paper-on-specified-risk.html
Sunday, June 07, 2009
L-TYPE-BSE, H-TYPE-BSE, C-TYPE-BSE, IBNC-TYPE-BSE, TME, CWD, SCRAPIE, CJD, NORTH AMERICA
http://bse-atypical.blogspot.com/2009/06/l-type-bse-h-type-bse-c-type-bse-ibnc.html
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
http://flounder068.vox.com/library/post/docket-no-fda2002n0031-formerly-docket-no-2002n0273-rin-0910af46.html
http://www.regulations.gov/fdmspublic/ContentViewer?objectId=09000064808b3843&disposition=attachment&contentType=pdf
Docket Management Docket: 02N-0273 - Substances Prohibited From Use in
Animal Food or Feed; Animal Proteins Prohibited in Ruminant Feed
Comment Number: EC -10
Accepted - Volume 2
http://www.fda.gov/ohrms/dockets/dailys/03/Jan03/012403/8004be07.html
PART 2
http://www.fda.gov/ohrms/dockets/dailys/03/Jan03/012403/8004be09.html
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
Docket APHIS-2007-0033 Docket Title Agricultural Bioterrorism Protection Act of 2002; Biennial Review and Republication of the Select Agent and Toxin List Docket Type Rulemaking Document APHIS-2007-0033-0001 Document Title Agricultural Bioterrorism Protection Act of 2002; Biennial Review and Republication of the Select Agent and Toxin List Public Submission APHIS-2007-0033-0002.1 Public Submission Title Attachment to Singeltary comment
http://www.regulations.gov/fdmspublic/component/main?main=DocumentDetail&o=090000648027c28e
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
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
http://madcowtesting.blogspot.com/2008/04/mbm-greaves-meat-offal-live-cattle.html
http://madcowfeed.blogspot.com/
Thursday, April 30, 2009
FDA Issues Final Guidance for Renderers on Substances Prohibited From Use in Animal Food or Feed CVM Update Back April 30, 2009
http://madcowfeed.blogspot.com/2009/04/fda-issues-final-guidance-for-renderers.html
Sunday, May 10, 2009
Identification and characterization of bovine spongiform encephalopathy cases diagnosed and NOT diagnosed in the United States
http://bse-atypical.blogspot.com/2009/05/identification-and-characterization-of.html
TSS
FDA BSE/Ruminant Feed Inspections Firms Inventory Report
Data reported as of: 06/06/2009 Search by: Last BSE Insp Date From 01/01/2009 To 06/10/2009 Sort by: FDA District, State, Firm Name
FDA District Firm Id (FEI) Firm Name Street Address City State Zip Code Opr. Status Firm Type(s) Prgm Risk Last BSE Insp Date Last BSE Dist. Dcsn** Handles Feed for Rum. Animals?
DAL-DO 3007064862 Mars Petcare US #1 Mars Road Clinton OK 73601 OPR PF HP 05/28/2009 OAI Y
ATL-DO 3007582627 Hoffner Brothers Dairy 610 Ketchie Rd Mount Ulla NC 28125-9685 OPR FR, OF, OT NP 02/03/2009 VAI Y
CIN-DO 3002766655 Lester J Stutzman Feed Mill 2811 Mt Zion Rd Marion KY 42064 OPR DR, FR, NL, OF DP 01/05/2009 VAI Y
CIN-DO 3003407434 Direct Action Co Inc 6668 Old SR 39 NW Dover OH 44622 OPR DR, NL, OT HP 05/04/2009 VAI Y
KAN-DO 1000050408 Mid-South Milling Co Inc 213 Central Ave Kansas City KS 66118-1117 OPR OT, PB, TH HP 01/14/2009 VAI N
KAN-DO 3007495971 Midwest Bulk Inc 3404 N Emporia St Wichita KS 67219-3615 OPR TH DP 02/26/2009 VAI Y
KAN-DO 3007458821 Murray Grain Co Inc 900 E 21st St N Ste 201 Wichita KS 67214-1406 OPR TH DP 02/26/2009 VAI Y
KAN-DO 3006292356 Orscheln Farm & Home 1702 W 11th St Coffeyville KS 67337-3115 OPR DR DP 02/02/2009 VAI Y
LOS-DO 2027094 Nestle, USA/ Nestle Prepared Foods Company 9601 Canoga Ave Chatsworth CA 91311-4115 OPR HF HP 05/26/2009 VAI N
NYK-DO 1310558 Birkett Mills 1 Main St Penn Yan NY 14527-1615 OPR DR, HF, NL NP 01/11/2009 RTS Y
Data reported as of: 06/06/2009 Search by: Last BSE Insp Date From 01/01/2003 To 06/10/2009 and Last BSE District Decision = OAI Sort by: FDA District, State, Firm Name
FDA District Firm Id (FEI) Firm Name Street Address City State Zip Code Opr. Status Firm Type(s) Prgm Risk Last BSE Insp Date Last BSE Dist. Dcsn** Handles Feed for Rum. Animals?
KAN-DO 1927975 Hahn & Phillips Grease Co Inc 913 N Odell, PO Box 130 Marshall MO 65340 OPR NL, PB, TH HP 12/22/2008 OAI Y
Legend - Opr.Status:OPR=Operational, SEA=Seasonal, PRP=Pre-Production, Firm Type: AF=Animal Feed/Pet Food Salvager, DR=Distributor/Retailer, FL=Feed Mill (FDA Licensed), FR=Feeder of Ruminants, HF=Human Food Processor, NL=Feed Mill (not FDA Licensed), OF=On-farm Feed Mixer, OT=Other, PB=Protein Blender, PF=Pet Food Manufacturer, RE=Renderer, RO=Feeder of Ruminants and Other Species, TH=Transporter (Hauler), Prgm Risk:DP=Only Distributes Prohib.Mat.(DP), HP=Handles Prohibited Materials(HP), NP=Does not handle Prohib.Mat.(NP), Dist Dcsn:OAI=Official Action Indicated (OAI), VAI=Voluntary Action Indicated (VAI), NAI=No Action Indicated (NAI), RTS=Referred to State (RTS),
http://www.accessdata.fda.gov/BSEInspect/bse_excel.jsp
February 6, 2004
To help prevent the establishment and amplification of BSE through feed in the United States, FDA implemented a final rule that prohibits the use of most mammalian protein in feeds for ruminant animals. This rule, Title 21 Part 589.2000 of the Code of Federal Regulations, became effective on August 4, 1997.
This is an update on FDA enforcement activities regarding the ruminant feed (BSE) regulation. FDA's CVM has assembled data from the inspections that have been conducted AND whose final inspection report has been recorded in the FDA's inspection database as of January 23, 2004. As of January 23, 2004, FDA had received over 26,000 inspection reports. The majority of these inspections (around 70%) were conducted by State officials under contract to FDA, with the remainder conducted by FDA officials.
Inspections conducted by FDA or State investigators are classified to reflect the compliance status at the time of the inspection based upon the objectionable conditions documented. These inspection conclusions are reported as Official Action Indicated (OAI), Voluntary Action Indicated (VAI), or No Action Indicated (NAI).
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
A VAI inspection classification occurs when objectionable conditions or practices were found that do not meet the threshold of regulatory significance, but do warrant advisory actions to inform the establishment of findings that should be voluntarily corrected. Inspections classified with VAI violations are more technical violations of Title 21 Part 589.2000 of the Code of Federal Regulations, (here called the Ruminant Feed Ban) became effective on August 4, 1997. Ruminant Feed Ban provisions such as minor recordkeeping lapses and conditions involving non-ruminant feeds.
A NAI inspection classification occurs when no objectionable conditions or practices were found during the inspection or the significance of the documented objectionable conditions found does not justify further actions.
The results to date are reported here both by “segment of industry” and “in total”. NOTE – A single firm can operate as more than one firm type. As a result, the categories of the different industry segments are not mutually exclusive.
http://www.fda.gov/AnimalVeterinary/NewsEvents/CVMUpdates/ucm048448.htm
Greetings,
THERE were 100s of NAI's, but you get the just. also, please note ;
>>>A VAI inspection classification occurs when objectionable conditions or practices were found that do not meet the threshold of regulatory significance, but do warrant advisory actions to inform the establishment of findings that should be voluntarily corrected. Inspections classified with VAI violations are more technical violations of Title 21 Part 589.2000 of the Code of Federal Regulations, (here called the Ruminant Feed Ban) became effective on August 4, 1997. Ruminant Feed Ban provisions such as minor recordkeeping lapses and conditions involving non-ruminant feeds.<<< href="http://www.fda.gov/foi/warning_letters/g4849d.htm">http://www.fda.gov/foi/warning_letters/g4849d.htm
Public Health Service Food and Drug Administration
Chicago District 550 West Jackson Blvd., 15th Floor Chicago, Illinois 60661 Telephone: 312-353-5863
July 12, 2004
WARNING LETTER CHI-16-04
CERTIFIED MAIL RETURN RECEIPT REQUESTED
Mr. Donald E. Hamilton, President/Owner Illini Feeds, Inc. P.O. Box 86, 1145 State Hwy. 94 Aledo, Illinois 61231
Dear Mr. Hamilton:
On February 19 and 20, 2004, the Food and Drug Administration (FDA) conducted an inspection of your animal feed handling facility located at 1145 State Highway 94, Aledo, Illinois. The inspection found significant deviations from the requirements set forth in Title 21, Code of Federal Regulations, Part 589.2000 (21 CFR 589.2000) - Animal Proteins Prohibited in Ruminant Feed. This regulation is intended to prevent the establishment and amplification of Bovine Spongiform Encephalopathy (BSE). The deviations cause the swine feed manufactured by your facility to be misbranded within the meaning of Section 403(a)(1) of the Federal Food, Drug, and Cosmetic Act (the Act).
Our investigation found that salvaged pet food containing prohibited material was added as an ingredient to the swine products manufactured at your facility. During the inspection, our investigator found that you failed to label your non-ruminant products with the required caution statement - Do not feed to cattle or other ruminants. [21 CFR 589.2000(d)(1)]
The above is not intended to be an all-inclusive list of violations. As a manufacturer of materials intended for use in animal feed, you are responsible for assuring that your overall operation and the products you manufacture and distribute are in compliance with the law.
You should take prompt action to correct this violation, and you should establish a system whereby such violations do not recur. Failure to promptly correct this violation may result in regulatory action without further notice, such as seizure and/or injunction.
During the inspection, you told the investigator that you would put the required cautionary statement on your products that contain prohibited material, and maintain tracking documents for all incoming ingredients, including animal proteins prohibited in ruminant feed. Please notify this office in writing within 15 working days of receiving this letter of any further steps you have taken to assure that your firm is in compliance with the law. Your response should also include an explanation of each step taken to correct the violations, and prevent their recurrence. Please include copies of any available documentation such as written procedures, corrected labeling, etc., demonstrating that corrections have been made. If corrections cannot be completed within 15 working days, state the reason for the delay and the date by which the corrections will be completed.
Your reply should be directed to Paul A. Boehmer, Compliance Officer, at the above address.
Sincerely,
/s/
Scott J. MacIntire District Director
http://www.fda.gov/foi/warning_letters/g4840d.htm
Public Health Service Food and Drug Administration
Chicago District 550 West Jackson Blvd., 15th Floor Chicago, Illinois 60661 Telephone: 312-353-5863
June 15, 2004
WARNING LETTER
CERTIFIED MAIL RETURN RECEIPT REQUESTED
Mr. David W. Bernauer CEO and Chairman of the Board Walgreen co. 200 Wilmot Rd. Deerfield, IL 60015
Dear Mr. Bernauer:
Inspection of your firms warehouse at 5100 Lake Terrace N.E., Mt. Vernon, Illinois, by the Illinois Department of Public Health and the U.S. Food and Drug Administration (FDA) on February 25, 26, and 27, and March 2, 2004, documented numerous insanitary conditions which caused the food and drug products stored there to become adulterated.
Our inspection showed that the food and drug products stored and held at your facility violated the Federal Food, Drug, and Cosmetic Act (the Act), rendering them adulterated. These adulterated fwd and drug products: a) consisted in whole or in part of filthy substances, including rodent fecal pellets, rodent hair, and insects, in violation of Section 402(a)(3) of the Act [21 U.S.C. 342(a)(3)]; and/or b) had been held under insanitary conditions whereby they have become contaminated with rodent filth, in violation of Sections 402(a)(4) and 501(a)(2)(a) of the Act [21 U.S.C. 342(a)(4), 351(a)(2)(a)].
Evidence of rodent activity documented throughout the old and new warehouse included dead mice in traps, excreta pellets, and gnawed paper material observed in, on, and near food and drugs stored in the warehouse. Rodents gnaw holes were observed into several packaged food products with rodent hairs at gnaw holes into products. Many more fecal pellets were on food and drug packages and still more were found near the stored foods, drugs, and cosmetics in the warehouse.
Other conditions observed during the inspection that could be contributing factors to rodent infestation include damaged and/or poorly fitting rail and truck dock doors, gaps around a conduit entry into the building, and the structural condition of the concrete and expansion gaps at floor/wall/support beam junctions in various areas of the warehouse allowing the entry or harborage of pests. Additionally, the investigators observed cobwebs, dead insects, dust, debris, product spillage, and papers in the warehouse, indicating a general lack of good sanitation practices.
Also, products that contain or may contain animal protein prohibited ruminant feed (BSE material) failed to bear the caution statement, Do not feed to cattle or other ruminants. Specifically, pet food products were salvaged, repackaged, and donated to [redacted] and other similar organizations in the area, without the proper labeling and agreement that they would not be used for ruminants. Please refer to Title 21, Code of Federal Regulations, Section 589.2000, concerning these requirements.
Our laboratory confirmed the findings of rodent excreta, rodent hairs on product gnaw holes, and rodent gnawed fibers (packaging material) sampled from the warehouse during the inspection.
The above listed violations are not intended to be all-inclusive. It is your responsibility to assure adherence with each requirement of the Act and its implementing regulations. The investigators reported that you destroyed food products that showed evidence of contamination and began to take some steps to correct the insanitary conditions in your facility. We request that you take prompt action to correct all violations.
Please provide this office, within 15 working days of receipt of this letter, a detailed response stating the actions you plan to take and have taken to correct and prevent the recurrence of these objectionable conditions. Provide the time within which corrections will be completed, reasons why any corrective action cannot be completed, and documentation to show that corrections have been made. Failure to take prompt action to correct all violations may result in regulatory action without further notice. Such action includes seizure and/or injunction.
Your reply should be directed to Paul A. Boehmer, Compliance Officer, at the Chicago District Office.
Sincerely,
/s/
Scott J. MacIntire District Director
cc: Stephen J. Lawrence, Distribution Center Manager Walgreen Co. 5100 Lake Terrace NE Mount Vernon, IL 62864-9665
http://www.fda.gov/foi/warning_letters/g4853d.htm
USA BSE GBR SHOULD BE GBR III, but someone dropped the ball...
TSS
######### http://mailhost-alt.rz.uni-karlsruhe.de/warc/bse-l.html ##########
Department of Health and Human Services Public Health Service Food and Drug Administration
Minneapolis District Office Central Region 212 Third Avenue South Minneapolis, MN 55401 Telephone: (612) 758-7119 FAX: (612) 334-4142
June 9, 2005
WARNING LETTER
CERTIFIED MAIL RETURN RECEIPT REQUESTED
Refer to MIN 05-15
Michael J. Langenhorst President Anamax Corporation P.O. Box 10067 Green Bay, WI 54307
Dear Mr. Langenhorst:
Our inspection of your rendering plant located at 505 Hardman Avenue South, South St. Paul, Minnesota, from January 12-20, 2005, revealed significant deviations from the requirements set forth in Title 21, Code of Federal Regulations , Part 589 .2000 (21 CFR 589 .2000), Animal Proteins Prohibited in Ruminant Feed. This regulation is intended to prevent the establishment and amplification of Bovine Spongiform Encephalopathy (BSE). Because you failed to follow the requirements of this regulation, products being manufactured and distributed by your facility are adulterated within the meaning of Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. 342(a)(4)], and misbranded within the meaning of Section 403(a)(1) of the Act [21 U.S.C. 343(a)(1)].
Our investigation found that you failed to provide for measures to prevent commingling or cross-contamination and to maintain sufficient written procedures [21 CFR 589.2000(e)] in that:
1. You failed to use clean-out procedures or other means adequate to prevent carryover of protein derived from mammalian tissues into feeds that may be used for ruminants.
2. You failed to maintain written procedures specifying the clean-out procedures or other means to prevent carryover of protein derived from mammalian tissues into feeds that may be used for ruminants.
Our investigation also found that you failed to label products that may contain protein derived from mammalian tissues with the statement, "Do not feed to cattle or other ruminants." For example, your Feather Meal and Stabilized Poultry By-Product Meal lack this statement, even though the absence of sufficient measures to avoid commingling or cross-contamination may result in these products containing protein derived from mammalian tissues. Because your products do not bear this caution statement, they are misbranded under Section 403(a)(1) of the Act [21 U.S .C. 343(a)(1)).
The above is not intended as an all-inclusive list of violations. As a manufacturer of materials intended for animal feed use, you are responsible for ensuring that your overall operation and the products you manufacture and distribute are in compliance with the law.
You should acknowledge this letter within 15 working days of receiving and include any additional corrective actions concerning your facility. We have received your letter dated January 31, 2005, which replies to the Form FDA-483 issued on January 20, 2005, and your letter dated February 25, 2005, that states all corrections have been implemented. The corrections you have reported appear to be adequate but will be evaluated further during our follow-up inspection.
Your response should be directed to Compliance Officer Jane E . Nelson at the address on the letterhead. If you have any questions regarding this letter, you may phone Ms. Nelson at (612) 758-7119.
Sincerely,
/S/
W. Charles Becoat Director Minneapolis District
http://www.fda.gov/foi/warning_letters/g5373d.pdf
New Orleans District 297 Plus Park Blvd. Nashville, TN 37217
Telephone: 615-781-5380 Fax: 615-781-5391
May 17, 2006
WARNING LETTER NO. 2006-NOL-06
FEDERAL EXPRESS OVERNIGHT DELIVERY
Mr. William Shirley, Jr., Owner Louisiana.DBA Riegel By-Products 2621 State Street Dallas, Texas 75204
Dear Mr. Shirley:
On February 12, 17, 21, and 22, 2006, a U.S. Food & Drug Administration (FDA) investigator inspected your rendering plant, located at 509 Fortson Street, Shreveport, Louisiana. The inspection revealed significant deviations from the requirements set forth in Title 21, Code of Federal Regulations, Part 589.2000 [21 CFR 589.2000], Animal Proteins Prohibited in Ruminant Feed. This regulation is intended to prevent the establishment and amplification of Bovine Spongiform Encephalopathy (BSE). You failed to follow the requirements of this regulation; products being manufactured and distributed by your facility are misbranded within the meaning of Section 403(a)(1) [21 USC 343(a)(1)] of the Federal Food, Drug, and Cosmetic Act (the Act).
Our investigation found you failed to provide measures, including sufficient written procedures, to prevent commingling or cross-contamination and to maintain sufficient written procedures [21 CFR 589.2000(e)] because:
You failed to use clean-out procedures or other means adequate to prevent carryover of protein derived from mammalian tissues into animal protein or feeds which may be used for ruminants. For example, your facility uses the same equipment to process mammalian and poultry tissues. However, you use only hot water to clean the cookers between processing tissues from each species. You do not clean the auger, hammer mill, grinder, and spouts after processing mammalian tissues.
You failed to maintain written procedures specifying the clean-out procedures or other means to prevent carryover of protein derived from mammalian tissues into feeds which may be used for ruminants.
As a result . the poultry meal you manufacture may contain protein derived from mammalian tissues prohibited in ruminant feed. Pursuant to 21 CFR 589.2000(e)(1)(i), any products containing or may contain protein derived from mammalian tissues must be labeled, "Do not feed to cattle or other ruminants." Since you failed to label a product which may contain protein derived from mammalian tissues with the required cautionary statement. the poultry meal is misbranded under Section 403(a)(1) [21 USC 343(a)(1)] of the Act.
This letter is not intended as an all-inclusive list of violations at your facility. As a manufacturer of materials intended for animal feed use, you are responsible for ensuring your overall operation and the products you manufacture and distribute are in compliance with the law. You should take prompt action to correct these violations, and you should establish a system whereby violations do not recur. Failure to promptly correct these violations may result in regulatory action, such as seizure and/or injunction, without further notice.
You should notify this office in writing within 15 working days of receiving this letter, outlining the specific steps you have taken to bring your firm into compliance with the law. Your response should include an explanation of each step taken to correct the violations and prevent their recurrence. If corrective action cannot be completed within 15 working days, state the reason for the delay and the date by which the corrections will be completed. Include copies of any available documentation demonstrating corrections have been made.
Your reply should be directed to Mark W. Rivero, Compliance Officer, U.S. Food and Drug Administration, 2424 Edenborn Avenue, Suite 410, Metairie, Louisiana 70001. If you have questions regarding any issue in this letter, please contact Mr. Rivero at (504) 219-8818, extension 103.
Sincerely,
/S
Carol S. Sanchez Acting District Director New Orleans District
http://www.fda.gov/foi/warning_letters/g5883d.htm
now that's what i'm talken about. but those were shut down just after the
Date: Wed, 2 Oct 2002 09:04:42 -0700
Reply-To: Bovine Spongiform Encephalopathy
Sender: Bovine Spongiform Encephalopathy
From: Terry S. Singeltary Sr.
Subject: MAD COW FEED BAN WARNING LETTERS USA 'update' (where did
all Terry's MAD COW warning letters go?)
Docket Management Docket: 02N-0273 - Substances Prohibited From ...
http://www.fda.gov/ohrms/dockets/dailys/03/Jan03/012403/8004be07.html
>>> Mr. Singeltary is correct that Dr. Detwiler asked participants to use the FDA ...... oh where, did all Terry's mad cow feed ban warning letters go$ >> >>FDA ...
www.fda.gov/ohrms/dockets/dailys/03/Jan03/012403/8004be07.html -
Subject: MAD COW FEED BAN WARNING LETTERS USA 'update' (where did all Terry's MAD COW warning letters go?)
From: "Terry S. Singeltary Sr." <mhtml:%7B33B38F65-8D2E-434D-8F9B-8BDCD77D3066%7Dmid://00000064/!x-usc:mailto:flounder@WT.NET>
Reply-To: Bovine Spongiform Encephalopathy <mhtml:%7B33B38F65-8D2E-434D-8F9B-8BDCD77D3066%7Dmid://00000064/!x-usc:mailto:BSE-L@UNI-KARLSRUHE.DE>
Date: Wed, 2 Oct 2002 09:04:42 -0700 Content-Type: text/plain
where, oh where, did all Terry's mad cow feed ban warning letters go$
FDA Cuts Back on Warnings
10/01/02
WASHINGTON -- The Food and Drug Administration has substantially cut back on warnings sent to companies that run afoul of its rules, a move the agency contends will result in more-effective enforcement but that critics say lets violators off the hook.
The drop results from a policy change in late February that requires the FDA chief counsel's office to clear all warning letters to ensure they are legally sound. Before the change, division and district offices around the country issued such letters unilaterally. In the six months since, the agency issued 279 warning letters, a drop of 64% from the same period last year, a review of agency records shows. The FDA says the chief counsel's office rejected only 6% of the 699 warning letters and other citations it reviewed. At the same time, division and district enforcers may be holding back letters they once would have sent.
SEE FULL STORY
http://online.wsj.com/
snip...end
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
Wednesday, January 28, 2009
TAFS1 Position Paper on Specified Risk Materials (January, 2009) TAFS INTERNATIONAL FORUM FOR TRANSMISSIBLE ANIMAL DISEASES AND FOOD SAFETY a non-profit Swiss Foundation(January 2009)TAFS1 Position Paper on Specified Risk Materials
http://madcowspontaneousnot.blogspot.com/2009/01/tafs1-position-paper-on-specified-risk.html
Sunday, June 07, 2009
L-TYPE-BSE, H-TYPE-BSE, C-TYPE-BSE, IBNC-TYPE-BSE, TME, CWD, SCRAPIE, CJD, NORTH AMERICA
http://bse-atypical.blogspot.com/2009/06/l-type-bse-h-type-bse-c-type-bse-ibnc.html
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
http://flounder068.vox.com/library/post/docket-no-fda2002n0031-formerly-docket-no-2002n0273-rin-0910af46.html
http://www.regulations.gov/fdmspublic/ContentViewer?objectId=09000064808b3843&disposition=attachment&contentType=pdf
Docket Management Docket: 02N-0273 - Substances Prohibited From Use in
Animal Food or Feed; Animal Proteins Prohibited in Ruminant Feed
Comment Number: EC -10
Accepted - Volume 2
http://www.fda.gov/ohrms/dockets/dailys/03/Jan03/012403/8004be07.html
PART 2
http://www.fda.gov/ohrms/dockets/dailys/03/Jan03/012403/8004be09.html
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
Docket APHIS-2007-0033 Docket Title Agricultural Bioterrorism Protection Act of 2002; Biennial Review and Republication of the Select Agent and Toxin List Docket Type Rulemaking Document APHIS-2007-0033-0001 Document Title Agricultural Bioterrorism Protection Act of 2002; Biennial Review and Republication of the Select Agent and Toxin List Public Submission APHIS-2007-0033-0002.1 Public Submission Title Attachment to Singeltary comment
http://www.regulations.gov/fdmspublic/component/main?main=DocumentDetail&o=090000648027c28e
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
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
http://madcowtesting.blogspot.com/2008/04/mbm-greaves-meat-offal-live-cattle.html
http://madcowfeed.blogspot.com/
Thursday, April 30, 2009
FDA Issues Final Guidance for Renderers on Substances Prohibited From Use in Animal Food or Feed CVM Update Back April 30, 2009
http://madcowfeed.blogspot.com/2009/04/fda-issues-final-guidance-for-renderers.html
Sunday, May 10, 2009
Identification and characterization of bovine spongiform encephalopathy cases diagnosed and NOT diagnosed in the United States
http://bse-atypical.blogspot.com/2009/05/identification-and-characterization-of.html
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