From: TSS ()
Subject: [Docket No. 2006N-0472] Proposed Collection; Substances Prohibited from Use in Animal Food or Feed; Animal Proteins Prohibited in Ruminant Feed
Date: February 15, 2007 at 9:41 am PST
Sent: Wednesday, February 14, 2007 5:43 PM
Subject: MAD COW PROTEIN IN COMMERCE PAPER WORK RECORD KEEPING TOO COSTLY, no need to keep records i suppose
my God, how stupid do they think we are $$$
[Federal Register: December 4, 2006 (Volume 71, Number 232)]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2006N-0472]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Substances Prohibited from Use in Animal Food or Feed;
Animal Proteins Prohibited in Ruminant Feed
AGENCY: Food and Drug Administration, HHS.
SUMMARY: The Food and Drug Administration (FDA) is announcing an
opportunity for public comment on the proposed collection of certain
information by the agency. Under the Paperwork Reduction Act of 1995
(the PRA), Federal agencies are required to publish notice in the
Federal Register concerning each proposed collection of information,
including each proposed extension of an existing collection of
information, and to allow 60 days for public comment in response to the
notice. This notice solicits comments on extending OMB approval on the
existing recordkeeping requirements for this information collection,
regarding animal proteins prohibited in ruminant feed.
DATES: Submit written or electronic comments on the collection of
information by February 2, 2007.
ADDRESSES: Submit electronic comments on the collection of information
Submit written comments on
the collection of information to the Division of Dockets Management
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852. All comments should be identified with the docket
number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Denver Presley, Jr., Office of the
Chief Information Officer (HFA-250), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-827-1472.
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal
agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice of the proposed collection
of information set forth in this document.
With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.
Substances Prohibited From Use in Animal Food or Feed; Animal Proteins
Prohibited in Ruminant Feed--21 CFR 589.2000(e)(1)(iv) (OMB Control
This information collection was established because epidemiological
evidence gathered in the United Kingdom suggested that bovine
spongiform encephalopathy (BSE), a progressively degenerative central
nervous system disease, is spread to ruminant animals by feeding
protein derived from ruminants infected with BSE. This regulation
places general requirements on persons that manufacture, blend,
distribute products that contain or may contain protein derived from
mammalian tissue, and feeds made from such products.
The respondents for this collection of information are
manufacturers and or distributors of products that contain or may
contain protein derived from mammalian tissues and feeds made from such
FDA estimates the burden of this collection of information as
Table 1.--Estimated Annual Recordkeeping Burden\1\
No. of Annual Frequency Total Annual
21 CFR Section Recordkeepers per Recordkeeping Records Hours per Record Total Hours
589.2000 (e)(1)(iv) 400 1 400 14 5,600
\1\There are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: November 28, 2006.
Assistant Commissioner for Policy
[FR Doc. E6-20476 Filed 12-01-06; 8:45 am]
BILLING CODE 4160-01-S
AFTER ALL THE BANNED ANIMAL PROTEIN THAT WENT INTO COMMERECE IN 2006 alone, I WOULD NOT DOUBT THE RECORD KEEPING
IS COSTLY. WHO NEEDS IT ANYWAY IF USDA/FDA et al are JUST GOING TO CONTINUE TO FEED COWS TO COWS IN THE USA, REFUSE
TO TEST TO FIND BSE/BASE/TSE, AND CONTINUE TO BELIEVE IN THE BSE MRR POLICY AS A POLICY OF SOUND SCIENCE, when we all
know it is nothing more than a legal tool to enhance export, commodities, futures, and has absolutely nothing at all to do with 'sound science'.
With the NEW BASE TSE in USA cattle that is linked to sporadic CJD, of which the last two mad cows in the USA (Alabama and Texas),
of which is more virulent to humans, does this not surprise anyone of this move by GW et al, conceal, cover-up, and shut the hell up, by some
lameduck excuse as trying to save paper, rather than report to the public mad cow feed ban violations. IT's like there other lameduck excuse of not
letting anyone test for mad cow disease with the damn Virus Serum Toxin Act of 1913, which gives the USDA ultimate authority to decide how
to manage certain types of potential health threats among livestock. right, the one's that cause the most monetary damage to the industry, and at
the same time has the potential to expose us all to a slow, silent death, until it goes clinical, and by then it is too late. This docket smells of cow
manure to me, a great deal of BSe. ...TSS
CONFERENCE ON PRION DISEASES OF NEUROPRION, NETWORK OF EXCELLENCE, TURIN, ITALY, 3-6 OCTOBER 2006
OUR OBSERVATIONS UNDERLINE THE HIGH SUSCEPTIBILITY OF A PRIMATE SPECIES TO THE BASE PRION STRAIN AND PROVIDE A BIOCHEMICAL BASIS FOR THE IDENTIFICATION OF A POTENTIAL OCCURRENCE IN MAN. ...page 9...tss
18 January 2007 - Draft minutes of the SEAC 95 meeting (426 KB) held on 7December 2006 are now available.snip...64. A member noted that at the recent Neuroprion meeting, a study waspresented showing that in transgenic mice BSE passaged in sheep may be morevirulent and infectious to a wider range of species than bovine derived BSE.Other work presented suggested that BSE and bovine amyloidotic spongiformencephalopathy (BASE) MAY BE RELATED. A mutation had been identified in theprion protein gene in an AMERICAN BASE CASE THAT WAS SIMILAR IN NATURE TO AMUTATION FOUND IN CASES OF SPORADIC CJD. snip... http://www.seac.gov.uk/minutes/95.pdf 3:30 Transmission of the Italian Atypical BSE (BASE) in Humanized Mouse Models Qingzhong Kong, Ph.D., Assistant Professor, Pathology, Case Western ReserveUniversityBovine Amyloid Spongiform Encephalopathy (BASE) is an atypical BSE straindiscovered recently in Italy, and similar or different atypical BSE caseswere also reported in other countries. The infectivity and phenotypes ofthese atypical BSE strains in humans are unknown. In collaboration withPierluigi Gambetti, as well as Maria Caramelli and her co-workers, we haveinoculated transgenic mice expressing human prion protein with brainhomogenates from BASE or BSE infected cattle. Our data shows that about halfof the BASE-inoculated mice became infected with an average incubation timeof about 19 months; in contrast, none of the BSE-inoculated mice appear tobe infected after more than 2 years. ***These results indicate that BASE is transmissible to humans and suggest that BASE is more virulent thanclassical BSE in humans.***6:30 Close of Day Onehttp://www.healthtech.com/2007/tse/day1.aspSEE STEADY INCREASE IN SPORADIC CJD IN THE USA FROM1997 TO 2006. SPORADIC CJD CASES TRIPLED, with phenotypeof 'UNKNOWN' strain growing. ...http://www.cjdsurveillance.com/resources-casereport.htmlThere is a growing number of human CJD cases, and they were presented lastweek in San Francisco by Luigi Gambatti(?) from his CJD surveillancecollection.He estimates that it may be up to 14 or 15 persons which display selectivelySPRPSC and practically no detected RPRPSC proteins.http://www.fda.gov/ohrms/dockets/ac/06/transcripts/1006-4240t1.htmhttp://www.fda.gov/ohrms/dockets/ac/06/transcripts/2006-4240t1.pdfFDA CERTIFIED MAD COW PROTEIN IN COMMERECE 2006Subject: MAD COW FEED RECALL USA SEPT 6, 2006 1961.72 TONS IN COMMERCE AL,TN, AND WVDate: September 6, 2006 at 7:58 am PSTPRODUCTa) EVSRC Custom dairy feed, Recall # V-130-6;b) Performance Chick Starter, Recall # V-131-6;c) Performance Quail Grower, Recall # V-132-6;d) Performance Pheasant Finisher, Recall # V-133-6.CODENoneRECALLING FIRM/MANUFACTURERDonaldson & Hasenbein/dba J&R Feed Service, Inc., Cullman, AL, by telephoneon June 23, 2006 and by letter dated July 19, 2006. Firm initiated recall iscomplete.REASONDairy and poultry feeds were possibly contaminated with ruminant basedprotein.VOLUME OF PRODUCT IN COMMERCE477.72 tonsDISTRIBUTIONAL______________________________PRODUCTa) Dairy feed, custom, Recall # V-134-6;b) Custom Dairy Feed with Monensin, Recall # V-135-6.CODENone. Bulk productRECALLING FIRM/MANUFACTURERRecalling Firm: Burkmann Feed, Greeneville, TN, by Telephone beginning onJune 28, 2006.Manufacturer: H. J. Baker & Bro., Inc., Albertville, AL. Firm initiatedrecall is complete.REASONPossible contamination of dairy feeds with ruminant derived meat and bonemeal.VOLUME OF PRODUCT IN COMMERCE1,484 tonsDISTRIBUTIONTN and WVhttp://www.fda.gov/bbs/topics/enforce/2006/ENF00968.htmlSubject: MAD COW FEED RECALLS ENFORCEMENT REPORT FOR AUGUST 9, 2006 KY, LA,MS, AL, GA, AND TN 11,000+ TONSDate: August 16, 2006 at 9:19 am PSTRECALLS AND FIELD CORRECTIONS: VETERINARY MEDICINE - CLASS II______________________________PRODUCTBulk custom made dairy feed, Recall # V-115-6CODENoneRECALLING FIRM/MANUFACTURERHiseville Feed & Seed Co., Hiseville, KY, by telephone and letter on orabout July 14, 2006. FDA initiated recall is ongoing.REASONCustom made feeds contain ingredient called Pro-Lak which may containruminant derived meat and bone meal.VOLUME OF PRODUCT IN COMMERCEApproximately 2,223 tonsDISTRIBUTIONKY______________________________PRODUCTBulk custom made dairy feed, Recall # V-116-6CODENoneRECALLING FIRM/MANUFACTURERRips Farm Center, Tollesboro, KY, by telephone and letter on July 14, 2006.FDA initiated recall is ongoing.REASONCustom made feeds contain ingredient called Pro-Lak which may containruminant derived meat and bone meal.VOLUME OF PRODUCT IN COMMERCE1,220 tonsDISTRIBUTIONKY______________________________PRODUCTBulk custom made dairy feed, Recall # V-117-6CODENoneRECALLING FIRM/MANUFACTURERKentwood Co-op, Kentwood, LA, by telephone on June 27, 2006. FDA initiatedrecall is completed.REASONPossible contamination of animal feed ingredients, including ingredientsthat are used in feed for dairy animals, with ruminant derived meat and bonemeal.VOLUME OF PRODUCT IN COMMERCE40 tonsDISTRIBUTIONLA and MS______________________________PRODUCTBulk Dairy Feed, Recall V-118-6CODENoneRECALLING FIRM/MANUFACTURERCal Maine Foods, Inc., Edwards, MS, by telephone on June 26, 2006. FDAinitiated recall is complete.REASONPossible contamination of animal feed ingredients, including ingredientsthat are used in feed for dairy animals, with ruminant derived meat and bonemeal.VOLUME OF PRODUCT IN COMMERCE7,150 tonsDISTRIBUTIONMS______________________________PRODUCTBulk custom dairy pre-mixes, Recall # V-119-6CODENoneRECALLING FIRM/MANUFACTURERWalthall County Co-op, Tylertown, MS, by telephone on June 26, 2006. Firminitiated recall is complete.REASONPossible contamination of dairy animal feeds with ruminant derived meat andbone meal.VOLUME OF PRODUCT IN COMMERCE87 tonsDISTRIBUTIONMS______________________________PRODUCTBulk custom dairy pre-mixes, Recall # V-120-6CODENoneRECALLING FIRM/MANUFACTURERWare Milling Inc., Houston, MS, by telephone on June 23, 2006. Firminitiated recall is complete.REASONPossible contamination of dairy animal feeds with ruminant derived meat andbone meal.VOLUME OF PRODUCT IN COMMERCE350 tonsDISTRIBUTIONAL and MS______________________________PRODUCTa) Tucker Milling, LLC Tm 32% Sinking Fish Grower, #2680-Pellet,50 lb. bags, Recall # V-121-6;b) Tucker Milling, LLC #31120, Game Bird Breeder Pellet,50 lb. bags, Recall # V-122-6;c) Tucker Milling, LLC #31232 Game Bird Grower,50 lb. bags, Recall # V-123-6;d) Tucker Milling, LLC 31227-Crumble, Game Bird Starter, BMDMedicated, 50 lb bags, Recall # V-124-6;e) Tucker Milling, LLC #31120, Game Bird Breeder, 50 lb bags,Recall # V-125-6;f) Tucker Milling, LLC #30230, 30 % Turkey Starter, 50 lb bags,Recall # V-126-6;g) Tucker Milling, LLC #30116, TM Broiler Finisher,50 lb bags, Recall # V-127-6CODEAll products manufactured from 02/01/2005 until 06/20/2006RECALLING FIRM/MANUFACTURERRecalling Firm: Tucker Milling LLC, Guntersville, AL, by telephone and visiton June 20, 2006, and by letter on June 23, 2006.Manufacturer: H. J. Baker and Brothers Inc., Stamford, CT. Firm initiatedrecall is ongoing.REASONPoultry and fish feeds which were possibly contaminated with ruminant basedprotein were not labeled as "Do not feed to ruminants".VOLUME OF PRODUCT IN COMMERCE7,541-50 lb bagsDISTRIBUTIONAL, GA, MS, and TNEND OF ENFORCEMENT REPORT FOR AUGUST 9, 2006###http://www.fda.gov/bbs/topics/ENFORCE/2006/ENF00964.htmlSubject: MAD COW FEED RECALL MI MAMMALIAN PROTEIN VOLUME OF PRODUCT INCOMMERCE 27,694,240 lbsDate: August 6, 2006 at 6:14 pm PSTPRODUCTBulk custom dairy feds manufactured from concentrates, Recall # V-113-6CODEAll dairy feeds produced between 2/1/05 and 6/16/06 and containing H. J.Baker recalled feed products.RECALLING FIRM/MANUFACTURERVita Plus Corp., Gagetown, MI, by visit beginning on June 21, 2006. Firminitiated recall is complete.REASONThe feed was manufactured from materials that may have been contaminatedwith mammalian protein.VOLUME OF PRODUCT IN COMMERCE27,694,240 lbsDISTRIBUTIONMIEND OF ENFORCEMENT REPORT FOR AUGUST 2, 2006###http://www.fda.gov/bbs/topics/enforce/2006/ENF00963.htmlSubject: MAD COW FEED RECALL AL AND FL VOLUME OF PRODUCT IN COMMERCE 125TONS Products manufactured from 02/01/2005 until 06/06/2006Date: August 6, 2006 at 6:16 pm PSTPRODUCTa) CO-OP 32% Sinking Catfish, Recall # V-100-6;b) Performance Sheep Pell W/Decox/A/N, medicated,net wt. 50 lbs, Recall # V-101-6;c) Pro 40% Swine Conc Meal -- 50 lb, Recall # V-102-6;d) CO-OP 32% Sinking Catfish Food Medicated,Recall # V-103-6;e) "Big Jim's" BBB Deer Ration, Big Buck Blend,Recall # V-104-6;f) CO-OP 40% Hog Supplement Medicated Pelleted,Tylosin 100 grams/ton, 50 lb. bag, Recall # V-105-6;g) Pig Starter Pell II, 18% W/MCDX Medicated 282020,Carbadox -- 0.0055%, Recall # V-106-6;h) CO-OP STARTER-GROWER CRUMBLES, CompleteFeed for Chickens from Hatch to 20 Weeks, Medicated,Bacitracin Methylene Disalicylate, 25 and 50 Lbs,Recall # V-107-6;i) CO-OP LAYING PELLETS, Complete Feed for LayingChickens, Recall # 108-6;j) CO-OP LAYING CRUMBLES, Recall # V-109-6;k) CO-OP QUAIL FLIGHT CONDITIONER MEDICATED,net wt 50 Lbs, Recall # V-110-6;l) CO-OP QUAIL STARTER MEDICATED, Net Wt. 50 Lbs,Recall # V-111-6;m) CO-OP QUAIL GROWER MEDICATED, 50 Lbs,Recall # V-112-6CODEProduct manufactured from 02/01/2005 until 06/06/2006RECALLING FIRM/MANUFACTURERAlabama Farmers Cooperative, Inc., Decatur, AL, by telephone, fax, email andvisit on June 9, 2006. FDA initiated recall is complete.REASONAnimal and fish feeds which were possibly contaminated with ruminant basedprotein not labeled as "Do not feed to ruminants".VOLUME OF PRODUCT IN COMMERCE125 tonsDISTRIBUTIONAL and FLEND OF ENFORCEMENT REPORT FOR AUGUST 2, 2006###http://www.fda.gov/bbs/topics/enforce/2006/ENF00963.htmlSubject: MAD COW FEED RECALL KY VOLUME OF PRODUCT IN COMMERCE ?????Date: August 6, 2006 at 6:19 pm PSTPRODUCTBulk custom made dairy feed, Recall # V-114-6CODENoneRECALLING FIRM/MANUFACTURERBurkmann Feeds LLC, Glasgow, KY, by letter on July 14, 2006. Firm initiatedrecall is ongoing.REASONCustom made feeds contain ingredient called Pro-Lak, which may containruminant derived meat and bone meal.VOLUME OF PRODUCT IN COMMERCE?????DISTRIBUTIONKYEND OF ENFORCEMENT REPORT FOR AUGUST 2, 2006###http://www.fda.gov/bbs/topics/enforce/2006/ENF00963.htmlMAD COW FEED RECALL USA EQUALS 10,878.06 TONS NATIONWIDESun Jul 16, 2006 09:22126.96.36.199RECALLS AND FIELD CORRECTIONS: VETERINARY MEDICINE -- CLASS II______________________________PRODUCTa) PRO-LAK, bulk weight, Protein Concentrate for Lactating Dairy Animals,Recall # V-079-6;b) ProAmino II, FOR PREFRESH AND LACTATING COWS, net weight 50lb (22.6 kg),Recall # V-080-6;c) PRO-PAK, MARINE & ANIMAL PROTEIN CONCENTRATE FOR USE IN ANIMALFEED, Recall # V-081-6;d) Feather Meal, Recall # V-082-6CODEa) Bulkb) Nonec) Bulkd) BulkRECALLING FIRM/MANUFACTURERH. J. Baker & Bro., Inc., Albertville, AL, by telephone on June 15, 2006 andby press release on June 16, 2006. Firm initiated recall is ongoing.REASONPossible contamination of animal feeds with ruminent derived meat and bonemeal.VOLUME OF PRODUCT IN COMMERCE10,878.06 tonsDISTRIBUTIONNationwideEND OF ENFORCEMENT REPORT FOR July 12, 2006###http://www.fda.gov/bbs/topics/enforce/2006/ENF00960.htmlSubject: MAD COW FEED BAN WARNING LETTER ISSUED MAY 17, 2006Date: June 27, 2006 at 7:42 am PSTPublic Health ServiceFood and Drug AdministrationNew Orleans District297 Plus Park Blvd.Nashville, TN 37217Telephone: 615-781-5380Fax: 615-781-5391May 17, 2006WARNING LETTER NO. 2006-NOL-06FEDERAL EXPRESSOVERNIGHT DELIVERYMr. William Shirley, Jr., OwnerLouisiana.DBA Riegel By-Products2621 State StreetDallas, Texas 75204Dear 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 FortsonStreet, Shreveport, Louisiana. The inspection revealed significantdeviations from the requirements set forth in Title 21, Code of FederalRegulations, Part 589.2000 [21 CFR 589.2000], Animal Proteins Prohibited inRuminant Feed. This regulation is intended to prevent the establishment andamplification of Bovine Spongiform Encephalopathy (BSE). You failed tofollow the requirements of this regulation; products being manufactured anddistributed by your facility are misbranded within the meaning of Section403(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 sufficientwritten procedures, to prevent commingling or cross-contamination and tomaintain sufficient written procedures [21 CFR 589.2000(e)] because:You failed to use clean-out procedures or other means adequate to preventcarryover of protein derived from mammalian tissues into animal protein orfeeds which may be used for ruminants. For example, your facility uses thesame equipment to process mammalian and poultry tissues. However, you useonly hot water to clean the cookers between processing tissues from eachspecies. You do not clean the auger, hammer mill, grinder, and spouts afterprocessing mammalian tissues.You failed to maintain written procedures specifying the clean-outprocedures or other means to prevent carryover of protein derived frommammalian tissues into feeds which may be used for ruminants.As a result . the poultry meal you manufacture may contain protein derivedfrom mammalian tissues prohibited in ruminant feed. Pursuant to 21 CFR589.2000(e)(1)(i), any products containing or may contain protein derivedfrom mammalian tissues must be labeled, "Do not feed to cattle or otherruminants." Since you failed to label a product which may contain proteinderived from mammalian tissues with the required cautionary statement. thepoultry meal is misbranded under Section 403(a)(1) [21 USC 343(a)(1)] of theAct.This letter is not intended as an all-inclusive list of violations at yourfacility. As a manufacturer of materials intended for animal feed use, youare responsible for ensuring your overall operation and the products youmanufacture and distribute are in compliance with the law. You should takeprompt action to correct these violations, and you should establish a systemwhereby violations do not recur. Failure to promptly correct theseviolations may result in regulatory action, such as seizure and/orinjunction, without further notice.You should notify this office in writing within 15 working days of receivingthis letter, outlining the specific steps you have taken to bring your firminto compliance with the law. Your response should include an explanation ofeach step taken to correct the violations and prevent their recurrence. Ifcorrective action cannot be completed within 15 working days, state thereason for the delay and the date by which the corrections will becompleted. Include copies of any available documentation demonstratingcorrections 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,/SCarol S. SanchezActing District DirectorNew Orleans Districthttp://www.fda.gov/foi/warning_letters/g5883d.htmlook at the table and you'll see that as little as 1 mg (or 0.001 gm) caused7% (1 of 14) of the cows to come down with BSE;Risk of oral infection with bovine spongiform encephalopathy agent inprimatesCorinne Ida Lasmézas, Emmanuel Comoy, Stephen Hawkins, Christian Herzog,Franck Mouthon, Timm Konold, Frédéric Auvré, Evelyne Correia, NathalieLescoutra-Etchegaray, Nicole Salès, Gerald Wells, Paul Brown, Jean-PhilippeDeslysSummary The uncertain extent of human exposure to bovine spongiformencephalopathy (BSE)--which can lead to variant Creutzfeldt-Jakob disease(vCJD)--is compounded by incomplete knowledge about the efficiency of oralinfection and the magnitude of any bovine-to-human biological barrier totransmission. We therefore investigated oral transmission of BSE tonon-human primates. We gave two macaques a 5 g oral dose of brain homogenatefrom a BSE-infected cow. One macaque developed vCJD-like neurologicaldisease 60 months after exposure, whereas the other remained free of diseaseat 76 months. On the basis of these findings and data from other studies, wemade a preliminary estimate of the food exposure risk for man, whichprovides additional assurance that existing public health measures canprevent transmission of BSE to man.snip...BSE bovine brain inoculum100 g 10 g 5 g 1 g 100 mg 10 mg 1 mg 0·1 mg 0·01 mgPrimate (oral route)* 1/2 (50%)Cattle (oral route)* 10/10 (100%) 7/9 (78%) 7/10 (70%) 3/15 (20%) 1/15 (7%)1/15 (7%)RIII mice (ic ip route)* 17/18 (94%) 15/17 (88%) 1/14 (7%)PrPres biochemical detectionThe comparison is made on the basis of calibration of the bovine inoculumused in our study with primates against a bovine brain inoculum with asimilar PrPres concentration that wasinoculated into mice and cattle.8 *Data are number of animalspositive/number of animals surviving at the time of clinical onset ofdisease in the first positive animal (%). The accuracy ofbioassays is generally judged to be about plus or minus 1 log. icip=intracerebral and intraperitoneal.Table 1: Comparison of transmission rates in primates and cattle infectedorally with similar BSE brain inoculaPublished online January 27, 2005http://www.thelancet.com/journal/journal.isaIt is clear that the designing scientists mustalso have shared Mr Bradley's surprise at the results because all the doselevels right down to 1 gram triggered infection.http://www.bseinquiry.gov.uk/files/ws/s145d.pdf26. It also appears to me that Mr Bradley's answer (that it would take lessthan say 100grams) was probably given with the benefit of hindsight; particularly if oneconsiders that later in the same answer Mr Bradley expresses his surprisethat itcould take as little of 1 gram of brain to cause BSE by the oral routewithin thesame species. This information did not become available until the "attackrate"experiment had been completed in 1995/96. This was a titration experimentdesigned to ascertain the infective dose. A range of dosages was used toensurethat the actual result was within both a lower and an upper limit within thestudyand the designing scientists would not have expected all the dose levels totriggerinfection. The dose ranges chosen by the most informed scientists at thattimeranged from 1 gram to three times one hundred grams. It is clear that thedesigningscientists must have also shared Mr Bradley's surprise at the resultsbecause all thedose levels right down to 1 gram triggered infection.http://www.bseinquiry.gov.uk/files/ws/s147f.pdfSuppressed peer review of Harvard study October 31, 2002. http://www.fsis.usda.gov/oa/topics/BSE_Peer_Review.pdf[Docket No. FSIS-2006-0011] FSIS Harvard Risk Assessment of BovineSpongiform Encephalopathy (BSE) http://www.fsis.usda.gov/OPPDE/Comments/2006-0011/2006-0011-1.pdf [Docket No. 03-025IFA] FSIS Prohibition of the Use of Specified Risk Materials for Human Food and Requirement for the Disposition of Non-Ambulatory Disabled Cattle 03-025IFA 03-025IFA-2 9/13/2005 http://www.fsis.usda.gov/OPPDE/Comments/03-025IFA/03-025IFA-2.pdf THE SEVEN SCIENTIST REPORT ***http://www.fda.gov/ohrms/dockets/dockets/02n0273/02n-0273-EC244-Attach-1.pdfPAUL BROWN M.D.http://www.fda.gov/ohrms/dockets/dockets/02n0273/02n-0273-c000490-vol40.pdf9 December 2005Division of Dockets Management (RFA-305)SEROLOGICALS CORPORATIONJames J. Kramer, Ph.D.Vice President, Corporate Operationshttp://www.fda.gov/ohrms/dockets/dockets/02n0273/02n-0273-c000383-01-vol35.pdfEmbassy of Japanhttp://www.fda.gov/ohrms/dockets/dockets/02n0273/02N-0273-EC240.htmDockets Entered on December 22, 20052005D-0330, Guidance for Industry and FDA Review Staff on Collection ofPlateletsby Automated ... EC 203, McDonald's Restaurants Corporation, Vol #:, 34 ...http://www.fda.gov/ohrms/dockets/dailys/05/Dec05/122205/122205.htm03-025IF 03-025IF-631 Linda A. Detwiler [PDF]Page 1. 03-025IF 03-025IF-631 Linda A. Detwiler Page 2. Page 3. Page 4.Page 5. Page 6. Page 7. Page 8. Page 9. Page 10. Page 11. Page 12.http://www.fsis.usda.gov/OPPDE/Comments/03-025IF/03-025IF-631.pdf03-025IF 03-025IF-634 Linda A. Detwiler [PDF]Page 1. 03-025IF 03-025IF-634 Linda A. Detwiler Page 2.Page 3. Page 4. Page 5. Page 6. Page 7. Page 8.http://www.fsis.usda.gov/OPPDE/Comments/03-025IF/03-025IF-634.pdfPage 1 of 17 9/13/2005 [PDF]... 2005 6:17 PM To: firstname.lastname@example.org Subject: [DocketNo. 03-025IFA]FSIS Prohibition of the Use of Specified Risk Materials for Human Food ...http://www.fsis.usda.gov/OPPDE/Comments/03-025IFA/03-025IFA-2.pdf03-025IFA 03-025IFA-6 Jason Frost [PDF]... Zealand Embassy COMMENTS ON FEDERAL REGISTER 9 CFR Parts 309 et al[Docket No. 03-025IF] Prohibition of the Use of Specified Risk Materials for Human Food and...http://www.fsis.usda.gov/OPPDE/Comments/03-025IFA/03-025IFA-6.pdfIn its opinion of 7-8 December 2000 (EC 2000), the SSC ... [PDF]Page 1. Linda A. Detwiler, DVM 225 Hwy 35 Red Bank, New Jersey 07701 Phone:732-741-2290Cell: 732-580-9391 Fax: 732-741-7751 June 22, 2005 FSIS Docket Clerk US ...http://www.fsis.usda.gov/OPPDE/Comments/03-025IF/03-025IF-589.pdf3. Mad Cow Disease: FDA's Management of the Feed Ban Has Improved,but Oversight Weaknesses Continue to Limit Program Effectiveness.GAO-05-101, Feb. 25.www.gao.gov/cgi-bin/getrpt?GAO-05-101Highlights - www.gao.gov/highlights/d05101high.pdf BSE; MRR; IMPORTATION OF LIVE BOVINES AND PRODUCTS DERIVED FROM BOVINES [Docket No. APHIS-2006-0041] RIN 0579-AC01FULL TEXT URL @http://lists.ifas.ufl.edu/cgi-bin/wa.exe?A2=ind0701&L=sanet-mg&T=0&P=8374http://lists.ifas.ufl.edu/cgi-bin/wa.exe?A2=ind0611&L=sanet-mg&T=0&P=3381OUTLOOK 07: US Pins Hope Of MAD COW Beef Trade On Safety Status from OIE (GOD HELP US)http://lists.ifas.ufl.edu/cgi-bin/wa.exe?A2=ind0612&L=sanet-mg&T=0&P=20678i have also sent many letters to FDA with no reply. i have ask all parties that represent this industry to respond to my question, with no luck. so again, i ask all USA Gov. lurkers on this list, including all FDA officials, please answer my question; where are the ruminant-to-ruminant feed ban violations now being documented for public viewing ???snip...no where did it state that they would cease to publish the ruminant-to-rumiant feed ban violations after the above publication. so, again, where are these now being posted on the web, what URL??? let us look at a review of past ruminant BSE feed ban warning letters. these are just the ones i found. most of you have seen them in the past, but it does not hurt to remind us of why they no longer post them to the public. if that is the case? snip...>>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?) >> >>snip... http://www.fda.gov/ohrms/dockets/dailys/03/Jan03/012403/8004be07.htmlPART IIhttp://www.fda.gov/ohrms/dockets/dailys/03/Jan03/012403/8004be09.htmlDocket
NEW BSE SAFEGUARDS
Federal Measures to Mitigate BSE Risks: Considerations for Further Action
No. 2003N-0312 Animal Feed Safety System [TSS SUBMISSION
TO DOCKET 2003N-0312]
Guidance for Industry: Use of Material From Deer and Elk In Animal
"But under the Bush administration, enforcement efforts have plummeted and serious violations are ...
GOTTA LOVE THOSE FDA/USDA TRIPLE BSE FIREWALLS. ...TSS
June 26, 2006, 11:10PM
Study shows drop in enforcement of FDA laws New York Times WASHINGTON -
An inquiry by a top House Democrat has found that enforcement of the nation's food and drug laws declined sharply during the first five years of the Bush administration. For instance, the 15-month investigation found, the number of warning letters that the Food and Drug Administration issued to drug companies, medical device makers and others dropped 54 percent, to 535 in 2005 from 1,154 in 2000. The seizure of mislabeled, defective or dangerous products dipped 44 percent, according to the inquiry, pursued by Rep. Henry Waxman, D-Calif., the senior Democrat on the House Government Reform Committee. The research found no evidence that such declines could be attributed to increased compliance with regulations. Investigators at the FDA continued to uncover about the same number of problems at drug and device companies as before, Waxman's inquiry found, but top officials of the agency increasingly overruled the investigators' enforcement recommendations. ..........
>> >>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, oh where, did all Terry's mad cow feed ban warning letters go$ >>
>>FDA Cuts Back on Warnings >>
>>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/ >>
>>Date: Wed, 9 Oct 2002 13:21:00 -0700
>>Reply-To: Bovine Spongiform Encephalopathy
>>Sender: Bovine Spongiform Encephalopathy
>>From: Terry S. Singeltary Sr.
>>Subject: 'TONNAGE' OF TAINTED FEED $ what's up with the mad cow warning
>> letters >>
>>since the FDA has apparently stopped issuing some warning letters; >> >>10/7/02 >>
>>Senate Questions FDA Commissioner Nominee >>
>>In testimony today before the U.S. Senate, Dr. Mark McClellan, the Bush
>>administration nominee for Commissioner of Food and Drugs, said that
>>under his leadership, the FDA would uphold its enforcement authority to
>>ensure the safety and effectiveness of the products it regulates and to
>>ensure that accurate and truthful information is conveyed to the public. >>
>>Sen. Edward Kennedy (D-Mass.), chairman of the Senate Health, Education,
>>Labor and Pensions (HELP) Committee, expressed concern at the start of
>>the hearing that the FDA may be backing away from its regulatory
>>authority, noting a drop in the number of Warning Letters issued by the
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