Whenever a U.S. cow turns up with mad cow disease, the authorities say lots of reassuring words: The cow was old, it never posed a risk to public health, etc.
It happened again after Monday’s announcement of a case in Alabama, the third in the nation since December 2003. “The animal was buried on the farm, and it did not enter the animal or human food chains,” said John Clifford, chief veterinarian for the U.S. Department of Agriculture. Maybe so, and maybe it won’t deter any Americans from visiting steakhouses tonight. But if Kansas ranchers and others are to see their markets for beef cattle rebound — most notably Japan — this can’t keep happening. Period.
Posted by Rhonda Holman
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24 Comments
This all started because some dumbass thought he could save money on feed by feeding cattle dead cattle.
…and the little packing plant in Ark City closes because the big meat packers dont want them testing their products and pronouncing them safe.
That would mean big packing plants would have to test for quality and safety, and, well, that simply cant happen. These guys just cant get used to the idea that others dont have to buy their trashy products. Americans are the only ones forced to do that!
The free market is only free when THEY say it is!
I fear this thread willnot get much attention. I have a personal interest in seeing that it does. I will post more later.
JR, cant you just see and hear big ag putting fingers in their ears and singing “lalalalalala” so they dont have to hear the truth?
Hmmm, I have the same vision of many food consumers doing the same thing.
Viva la small producers!
Damn right, FrmGrl. It’s what the consumers want but ag monopolies won’t give it to us.
Explain to me how that’s a free market again?
It would add a tenth of cent increase per pound of beef, so it doesn’t get done . . .
KFG
Please pay attention to this thread. I need your help with the agricultural aspects.
Fellow bloggers, if ever I wanted to get your attention and make a difference on an issue it is this one.
I will make each of my post as to this issue in 2 parts. The first paragraph will address the disease. The second will tell my story and why it is so important to me that this issue be addressed.
I will try not to be long or boring. I hope you will favor me with you attention. YOu don’t have to post back. If you have questions ask. If you are reading me let me know just with a simple acknowledgement.
Mad cow disease. We hear about it. Like so many things it is a soundbite. Sky is falling kind of stuff even.
My father was a hale and healthy man on Fathers’ Day 2005 and on his 77th birthday in late July 2005.
“Mad cow” describes symptoms. The scientific name is Bovine spongiform encephapathology. That translates as Cow brain damage.
My fathers difficulties began in June. An avid bowler, he fell a few times as the season ended in June. ThroughJuly and August, his vision and balance failed. Various test found nothing.
Bovine spongiform ecephapathology. Cow spongelike brain damage. The most simple form of life that we know are viruses. BSE or mad cow is caused by PRIONS. Please do your own research as to PRIONS. These are not viruses. They are not entirely alive. They are exceedingly difficult to destroy.
By August, my father was becoming increasingly incoherent and forgetful. In his youth a record setter in track and field, he came to depend on a cane to walk.
JR, BSE is a terrible disease that causes a horrible death. The horror is compounded by the fact that it is almost entirely preventable. Just like other food borne diseases.
The u.s. has outsourced its own food supply while trying to pawn off our inferior, mass produced, heavily subsidized products to the rest of the world as “cheap food”. We cant compete on quality (the canadians clean their wheat at the FARM, we dont even do it at the elevator!) so we just flood the market with crappy product at the lowest subsidized price.
Chinese manufacturing anyone?
Bad enough big ag doesnt care about its food products, but then they stop other producers from certifying the quality of THEIR products?
Only those with enough disposable income can eat locally and eat organically. The rest of the world? I guess big ag just thinks they can eat cake.
We just think BSE cant happen here, but it already has.
Sorry for your family’s loss JR.
Thanks KFG.
PRIONS “survive” all current forms of sterilization. They can “survive” at temperatures that melt lead. Occuring naturally, they reside in neural tissue.
By my brothers wedding i Sept., my Dad could barely stand, even with a walker. Extensive test performed, the Dr.s could tell us nothing.
JR–
I’m sorry to hear about your tragic loss.
Your father died of Creutzfeldt-Jakob disease?
Was there any link to BSE or are you pointing out what can happen if BSE isn’t stopped and the public protected?
PRIONS and the disease they cause ae vanishingly rare. Transmission/infection occurs through infected nerve tissue. The disease in cattle is currently spread by cattle being fed “scrapple” which is essentially slaughterhouse leftovers…….sometimes including neural tissue as a protein feed supplement.
By the end of September, my Dad was confined to a wheelchair. His speech, vision, recognition and memory continued to degenerate. Dad was sent for physical therapy as the Dr.s continued to be completely at a loss to explain what was happening to him.
PL Thanks. BSE = Creutzfeld Jakob disease…. in humans.
Let me be very clear here. My Dad did NOT die from eating infected beef! The disease as occurs naturally in humans statistically strikes about one in one million people.
CJD was first found in humans in Germany in 1930. And yes I’m hping to bring attention to what could happen to a whole lot of people.
The scares over mad cow disease are something we had better take very seriously. Only we aren’t. As KFG posted above and I hope will continue to post, increasing lack of regulation (especially under this administration) to cut costs, makes this a disease that could affect milions.
I hope by sharing my experience and knowledge of this disease, I may get others to see it as more than a soundbite.
BSE/CJD etc. Perhaps even more scary is the variant found in wild animals such as deer. They ain’t being fed tainted feed.
I am less familiar with the the disease found in game. I think you are talking about chronic wasting disease. I am not sure if it is related to CJD/BSE.
By mid October, my father could no longer negotiate getting into the bathroom without falling……even with the aid of his walker. Long posters to this forum may remember that I had to excuse myself from devoting timeto posts at that time, as it became necessary for me to move in with my folks to help out.
JR and I talked about this on a long ago thread. I had a neighbor here, in 1976, who died of JC. They didnt know what it was back then, but now we do know that is what caused her death.
She was one of my 4-H leaders and a wonderful, vital, athletic woman who died a really awful, slow death. Imagine it on a larger scale, and the disease takes a while to show itself. Trouble on the hoof, so to speak.
E coli, BSE, all manner of food borne illnesses can be easily prevented. Little producers like me can find a niche in the market for locally grown, locally processed, high quality food. Transportation invites improper storage and increases the risk of food illnesses. BUY LOCAL WHEN POSSIBLE!
Local packing plants can find a niche too, but it is almost too late for them. They got regulated out of business while the big plants got their regulations loosened. How the hell does that happen?
I have floor plans for a packing plant operation that would virtually eliminate e coli and other contamination. I’ve had them since 1994, but no financing available. BTW, the plans are in the public domain. Hmmm….
Of course all this adds to the cost of food, which is why I say that these days, you can get good food and you can get cheap food, but good AND cheap are hard to find. Unless it is unprocessed and purchased locally.
There are some food stamp programs now that allow them to be spent at farmers markets. Those should be encouraged, but…sigh….the new farm bill chose subisidies for big ag over the food stamp program. To pay for the war, something had to give in the budget.
LOL, you didnt think it would be big ag did you? Just thank your congressional delegation again for supporting sustainable ag and good, nutritious AFFORDABLE food.
And maybe we could use some education on preparing whole foods, without the store’s capital letters! Hell, no one knows how to cook anymore, much less grocery shop!! But as joe williams pointed out, the extension service is a big ag lacky and has strayed far from its land grant mission.
Some of the answers are in establishing direct urban-rural links so farmers and consumers can cut out big processors as much as possible. Now that is effective economic development on many levels.
Kansassam, what do you think here? Would you like to get produce and food directly from the farmers and still save some money? I think we could cooperate on some regulatory reform for programs like yours. And farms like mine :)
If we had more of those fresh food links, urban ks might actually care about the future of the west if they see their own self-interest. And the west might have a little more self respect if they thought the rest of the state valued them for something other than a buffer to colorado.
BTW, economic development, there is a correlation between states with a hot economy and population growth, and the states that have the fastest growing organic food sectors. I will see if I can find the research, but think CA and FL and TX.
Yikes, sorry for going so far off topic. JR, I didnt mean to hijack the thread. Just a subject I have had way too much time to think about. It is also a subject that actually has some answers and some possibility for kansas.
Let’s just not let big ag and stupid water policy ruin it.
Uh oh, now I’m gonna be late to the picnic. Finishing up the ‘tater salad now. JR, hope you will be there.
And the picnic went well.
Another thread to this disease is current.
I’ll continue my story.
By early November the Drs still had no answers. A spinal tap was ordered.
After the spinal tap, my dad was ordered to remain prone in bed to recover. There was little need to restrain him. He could no longer get out of bed.
As my dad could no longer get out of bed, we checked him into the hospital two days after his spinal tap.
Still with no answers as to his decline, he was after 2 days transferred to the senior behavior unit. The concern was to whether he simply did not want to get better.
By now, he could not even feed himself.
JR, remember what I said about not reading threads carefully?
Here’s my belated sympathies. And thanks. I avoid beef anyway–blood pressure issues–but your info is chilling.
Volume 12, Number 12–December 2006PERSPECTIVE
On the Question of Sporadic
or Atypical Bovine SpongiformEncephalopathy and
Creutzfeldt-Jakob Disease
Paul Brown,* Lisa M. McShane,† Gianluigi Zanusso,‡ and Linda Detwiler§
Strategies to investigate the possible existence of sporadic
bovine spongiform encephalopathy (BSE) require
systematic testing programs to identify cases in countries
considered to have little or no risk for orally acquired disease,
or to detect a stable occurrence of atypical cases in
countries in which orally acquired disease is disappearing.
To achieve 95% statistical confidence that the prevalence
of sporadic BSE is no greater than 1 per million (i.e., the
annual incidence of sporadic Creutzfeldt-Jakob disease
[CJD] in humans) would require negative tests in 3 million
randomly selected older cattle. A link between BSE and
sporadic CJD has been suggested on the basis of laboratory
studies but is unsupported by epidemiologic observation.
Such a link might yet be established by the discovery
of a specific molecular marker or of particular combinations
of trends over time of typical and atypical BSE and various
subtypes of sporadic CJD, as their numbers are influenced
by a continuation of current public health measures that
exclude high-risk bovine tissues from the animal and
human food chains.SNIP…Sporadic CJDThe possibility that at least some cases of apparently sporadic CJD might be due to infection by sporadic cases of BSE cannot be dismissed outright. Screening programs needed to identify sporadic BSE have yet to be implemented, and we know from already extant testing programs that at least a proportion of infected animals have no symptoms and thus would never be identified in the absence of systematic testing. Thus, sporadic BSE (or for that matter, sporadic disease in any mammalian species) might be occurring on a regular basis at perhaps the same annual frequency as sporadic CJD in humans, that is, in the range of 1 case per million animals.
Whether humans might be more susceptible to atypical forms of BSE cannot be answered at this time. Experimentally transmitted BASE shows shorter incubation periods than BSE in at least 1 breed of cattle, bovinized transgenic mice, and Cynomolgus monkeys (12,13). In humanized transgenic mice, BASE transmitted, whereas typical BSE did not transmit (13). Paradoxically, the other major phenotype (H) showed an unusually long incubation period in bovinized transgenic mice (12).
The limited experimental evidence bearing on a possible relationship between BSE and sporadic CJD is difficult to interpret. The original atypical BASE strain of BSE had a molecular protein signature very similar to that of 1 subtype (type 2 M/V) of sporadic CJD in humans (5). In another study, a strain of typical BSE injected into humanized mice encoding valine at codon 129 showed a glycopattern indistinguishable from the same subtype of sporadic CJD (15). In a third study, the glycopatterns of both the H and L strains of atypical BSE evidently did not resemble any of the known sporadic CJD subtypes (12).
To these molecular biology observations can be added the epidemiologic data accumulated during the past 30 years. The hypothesis that at least some cases of apparently sporadic CJD are due to unrecognized BSE infections cannot be formally refuted, but if correct, we might expect by now to have some epidemiologic evidence linking BSE to at least 1 cluster of apparently sporadic cases of CJD. Although only a few clusters have been found (and still fewer published), every proposed cluster that has been investigated has failed to show any common exposure to bovines. For that matter, no common exposure has been shown to any environmental vehicles of infection, including the consumption of foodstuffs from bovine, ovine, and porcine sources, the 3 livestock species known to be susceptible to transmissible spongiform encephalopathies. Additional negative evidence comes from several large case-control studies in which no statistically significant dietary differences were observed between patients with sporadic CJD and controls (16,17).
On the other hand, the difficulty of establishing a link between BSE and CJD may be compounded by our ignorance of the infectious parameters of a sporadic form of BSE (e.g., host range, tissue distribution of infectivity, route of transmission, minimum infectious dose for humans, whether single or multiple). Presumably, these parameters would resemble those of variant CJD; that is, high infectivity central nervous system and lymphoreticular tissues of an infected cow find their way into products consumed by humans. Transmissions that might have occurred in the past would be difficult to detect because meat products are generally not distributed in a way that results in detectable geographic clusters.
Barring the discovery of a specific molecular signature (as in variant CJD), the most convincing clue to an association will come from the observation of trends over time of the incidence of typical and atypical BSE and of sporadic and variant CJD. With 4 diseases, each of which could have increasing, unchanging, or decreasing trends, there could be 81 (34) possible different combinations. However, it is highly likely that the trends for typical BSE and variant CJD will both decrease in parallel as feed bans continue to interrupt recycled contamination. The remaining combinations are thus reduced to 9 (32), and some of them could be highly informative.
For example, if the incidence of atypical BSE declines in parallel with that of typical BSE, its candidacy as a sporadic form of disease would be eliminated (because sporadic disease would not be influenced by current measures to prevent oral infection). If, on the other hand, atypical BSE continues to occur as typical BSE disappears, this would be a strong indication that it is indeed sporadic, and if in addition at least 1 form of what is presently considered as sporadic CJD (such as the type 2 M/V subtype shown to have a Western blot signature like BASE) were to increase, this would suggest (although not prove) a causal relationship (Figure 5).
Recognition of the different forms of BSE and CJD depends upon continuing systematic testing for both bovines and humans, but bovine testing will be vulnerable to heavy pressure from industry to dismantle the program as the commercial impact of declining BSE cases ceases to be an issue. Industry should be aware, however, of the implications of sporadic BSE. Its occurrence would necessitate the indefinite retention of all of the public health measures that exclude high-risk bovine tissues from the animal and human food chains, whereas its nonoccurrence would permit tissues that are now destroyed to be used as before, once orally acquired BSE has disappeared.
SNIP…
PLEASE READ FULL TEXT ;
http://www.cdc.gov/ncidod/EID/vol12no12/06-0965.htm?s_cid=eid06_0965_e
3:00 Afternoon Refreshment Break, Poster and Exhibit Viewing in the ExhibitHall
3:30 Transmission of the Italian Atypical BSE (BASE) in Humanized Mouse
Models Qingzhong Kong, Ph.D., Assistant Professor, Pathology, Case Western ReserveUniversity
Bovine 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 istransmissible to humans and suggest that BASE is more virulent thanclassical BSE in humans.
6:30 Close of Day One
http://www.healthtech.com/2007/tse/day1.asp
SEE 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.html
There 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.htm
http://www.fda.gov/ohrms/dockets/ac/06/transcripts/2006-4240t1.pdfJOURNAL OF NEUROLOGYMARCH 26, 2003
RE-Monitoring the occurrence of emerging forms of Creutzfeldt-Jakob
disease in the United States
Email Terry S. Singeltary:
flounder@wt.net
I lost my mother to hvCJD (Heidenhain Variant CJD). I would like to
comment on the CDC’s attempts to monitor the occurrence of emerging
forms of CJD. Asante, Collinge et al [1] have reported that BSE
transmission to the 129-methionine genotype can lead to an alternate
phenotype that is indistinguishable from type 2 PrPSc, the commonest
sporadic CJD. However, CJD and all human TSEs are not reportable
nationally. CJD and all human TSEs must be made reportable in every
state and internationally. I hope that the CDC does not continue to
expect us to still believe that the 85%+ of all CJD cases which are
sporadic are all spontaneous, without route/source. We have many TSEs in
the USA in both animal and man. CWD in deer/elk is spreading rapidly and
CWD does transmit to mink, ferret, cattle, and squirrel monkey by
intracerebral inoculation. With the known incubation periods in other
TSEs, oral transmission studies of CWD may take much longer. Every
victim/family of CJD/TSEs should be asked about route and source of this
agent. To prolong this will only spread the agent and needlessly expose
others. In light of the findings of Asante and Collinge et al, there
should be drastic measures to safeguard the medical and surgical arena
from sporadic CJDs and all human TSEs. I only ponder how many sporadic
CJDs in the USA are type 2 PrPSc?
http://www.neurology.org/cgi/eletters/60/2/176#535Diagnosis and Reporting of Creutzfeldt-Jakob Disease
Singeltary, Sr et al. JAMA.2001; 285: 733-734.
http://jama.ama-assn.org/cgi/content/full/285/6/733?maxtoshow=&HITS=10&hits=10&RESULTFORMAT=&fulltext=dignosing+and+reporting+creutzfeldt+jakob+disease&searchid=1048865596978_1528&stored_search=&FIRSTINDEX=0&journalcode=jama
BRITISH MEDICAL JOURNAL
BMJ
http://www.bmj.com/cgi/eletters/319/7220/1312/b#EL2
BMJ
http://www.bmj.com/cgi/eletters/320/7226/8/b#EL1
[Docket No. 03-025IFA] FSIS Prohibition of the Use of Specified RiskMaterials for Human Food and Requirement for the Disposition ofNon-Ambulatory Disabled Cattle
http://www.fsis.usda.gov/OPPDE/Comments/03-025IFA/03-025IFA-2.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
THE SEVEN SCIENTIST REPORT ***
http://www.fda.gov/ohrms/dockets/dockets/02n0273/02n-0273-EC244-Attach-1.pdf
PAUL BROWN M.D.
http://www.fda.gov/ohrms/dockets/dockets/02n0273/02n-0273-c000490-vol40.pdf
9 December 2005Division of Dockets Management (RFA-305)
SEROLOGICALS CORPORATIONJames J. Kramer, Ph.D.Vice President, Corporate Operations
http://www.fda.gov/ohrms/dockets/dockets/02n0273/02n-0273-c000383-01-vol35.pdf
Embassy of Japanhttp://www.fda.gov/ohrms/dockets/dockets/02n0273/02N-0273-EC240.htm
Dockets 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.htm
03-025IF 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.pdf
03-025IF 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.pdf
Page 1 of 17 9/13/2005 [PDF]… 2005 6:17 PM To: fsis.regulationscomments@fsis.usda.gov 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.pdf
03-025IFA 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.pdf
In 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.pdf
Terry S. Singeltary SR.P.O. Box 42Bacliff, Texas USA 77518
##################### Bovine Spongiform Encephalopathy #####################
Subject: MAD COW FDA FEED WARNING LETTER NO. 2007-NOL-01 October 26, 2006 H.J. Baker & Bro., Inc.Date: November 7, 2006 at 9:08 am PSTFood and Drug Administration
New Orleans District
404 BNA Drive, Building 200, Suite 500
Nashville, TN 37217
Telephone: 615-366-7801
Facsimile: 615-366-7802
October 26, 2006
WARNING LETTER NO. 2007-NOL-01
FEDERAL EXPRESS
OVERNIGHT DELIVERY
Mr. Christopher V. B. Smith
Corporate President, CEO
H. J. Baker & Bro., Inc.
228 Saugatuck Avenue
Westport, Connecticut 06880
Dear Mr. Smith:
On June 6, 8, 12-15, and 23, 2006, a U.S . Food and Drug Administration (FDA) investigator inspected
your animal feed protein supplement manufacturing facility, located at 603 Railroad Avenue,
Albertville, Alabama. The inspection revealed significant deviations from the requirements set forth in
Title 21, Code ofFederal 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, resulting
in products being manufactured and distributed by your facility because they are adulterated within the
meaning of Section 402(a)(4) [21 USC 342(a)(4)] of the Federal Food, Drug, and Cosmetic Act (the
Act) and misbranded within the meaning of Section 403(a)(1) [21 USC 343(a)(1)] of the Act.
Our investigation determined adulteration resulted from the failure of your firm to establish and
implement measures sufficient to prevent commingling or cross-contamination . The adulterated feed
was subsequently misbranded because it was not properly labeled. Specifically, we found :
” Your firm failed to establish and use cleanout procedures or other means to prevent carry-over of
products which contain or may contain protein derived from mammalian tissues into animal protein
or feeds which may be used for ruminants, as required by 21 CFR 589.2000(e)(1)(iii)(B) .
Specifically, you failed to establish and use such measures for a screw auger installed in February
2005 . This auger is used to convey both prohibited and non-prohibited material to bulk storage bins.
In addition, you failed to follow the cleanout procedure your firm had developed for the receiving
systems. Your feed is, therefore, adulterated under Section 402(a)(4) [21 USC 342(a)(4)] of the Act.
” You failed to label all products which contained or may have contained prohibited materials with the
BSE cautionary statement, “Do not feed to cattle or other ruminants,” as required by 21 CFR
589.2000(e)(1)(i) . Such products are misbranded under Section 403(3) [21 USC 343(a)(1)] of the
Act. These misbranded products include the three Pro-Pak products mentioned below, as well as
Page 2 – H. J . Baker & Bro., Inc., Albertville, Alabama Warning Letter No. 2007-NOL-O 1
those bulk loads of individual feed ingredients processed through this common screw auger and
distributed between the time it was installed in February 2005, and June 9, 2006 .
This letter is not intended to serve 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.
We acknowledge your June 16, 2006, voluntary recall of three products you manufactured from
February 2005 to June 2006. The three products recalled were: Pro-Lak Protein Concentrate for
Lactating Dairy Animals; Pro-Amino II for PreFresh and Lactating Cows; and, Pro-Pak Marine & Animal Protein Concentrate for Use in Animal Feed. Recall effectiveness checks and other measures
will determine the merit of this recall . We recognize you now label all products with the required BSE
cautionary statement and we also acknowledge your intent, given verbally to New Orleans District
management of the FDA, to discontinue the production of supplements which do not contain prohibited
materials. In your written response to this letter, please confirm in writing you have taken these steps.
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, including the steps we acknowledge above and any additional steps you have taken. 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 Kari L. Batey, Compliance Officer, at the address above. If you have
questions regarding any issue in this letter, please contact Ms. Batey at (615) 366-7808.
Sincerely,
,
Carol S . Sanchez
Acting District Director
New Orleans District
Enclosure: Form FDA 483
cc: Craig R. Waterhouse
Plant Manager
H.J. Baker & Bros., Inc.
603 Railroad Avenue
Albertville, Alabama 35951-3419
http://www.fda.gov/foi/warning_letters/g6104d.pdf
TSS
MORE 2006 FEED BAN VIOLATIONS BELOW, ”IN COMMERCE” ;
Subject: MAD COW FEED RECALL USA SEPT 6, 2006 1961.72 TONS IN COMMERCE AL,TN, AND WVDate: September 6, 2006 at 7:58 am PST
PRODUCTa) 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 WV
http://www.fda.gov/bbs/topics/enforce/2006/ENF00968.html
Subject: 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 PST
RECALLS 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 TN
END OF ENFORCEMENT REPORT FOR AUGUST 9, 2006
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http://www.fda.gov/bbs/topics/ENFORCE/2006/ENF00964.html
Subject: 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 lbsDISTRIBUTIONMI
END OF ENFORCEMENT REPORT FOR AUGUST 2, 2006
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http://www.fda.gov/bbs/topics/enforce/2006/ENF00963.html
Subject: 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 FL
END OF ENFORCEMENT REPORT FOR AUGUST 2, 2006
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http://www.fda.gov/bbs/topics/enforce/2006/ENF00963.html
Subject: 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.html
CJD WATCH MESSAGE BOARDTSSMAD COW FEED RECALL USA EQUALS 10,878.06 TONS NATIONWIDESun Jul 16, 2006 09:2271.248.128.67
RECALLS 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 tonsDISTRIBUTIONNationwide
END OF ENFORCEMENT REPORT FOR July 12, 2006
###
http://www.fda.gov/bbs/topics/enforce/2006/ENF00960.html
Subject: MAD COW FEED BAN WARNING LETTER ISSUED MAY 17, 2006Date: June 27, 2006 at 7:42 am PSTPublic Health ServiceFood and Drug Administration
New Orleans District297 Plus Park Blvd.Nashville, TN 37217
Telephone: 615-781-5380Fax: 615-781-5391
May 17, 2006
WARNING LETTER NO. 2006-NOL-06
FEDERAL EXPRESSOVERNIGHT DELIVERY
Mr. William Shirley, Jr., OwnerLouisiana.DBA Riegel By-Products2621 State StreetDallas, 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 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,
/S
Carol S. SanchezActing District DirectorNew Orleans District
http://www.fda.gov/foi/warning_letters/g5883d.htm
look 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 inprimates
Corinne 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 inoculum
100 g 10 g 5 g 1 g 100 mg 10 mg 1 mg 0·1 mg 0·01 mg
Primate (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 detection
The 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 was
inoculated 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 of
bioassays 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 inocula
Published online January 27, 2005
http://www.thelancet.com/journal/journal.isa
It is clear that the designing scientists must
also have shared Mr Bradley’s surprise at the results because all the dose
levels right down to 1 gram triggered infection.
http://www.bseinquiry.gov.uk/files/ws/s145d.pdf
2
6. It also appears to me that Mr Bradley’s answer (that it would take lessthan say 100
grams) was probably given with the benefit of hindsight; particularly if one
considers that later in the same answer Mr Bradley expresses his surprisethat it
could take as little of 1 gram of brain to cause BSE by the oral routewithin the
same species. This information did not become available until the “attackrate”
experiment had been completed in 1995/96. This was a titration experiment
designed to ascertain the infective dose. A range of dosages was used toensure
that the actual result was within both a lower and an upper limit within thestudy
and the designing scientists would not have expected all the dose levels totrigger
infection. The dose ranges chosen by the most informed scientists at thattime
ranged from 1 gram to three times one hundred grams. It is clear that thedesigning
scientists must have also shared Mr Bradley’s surprise at the resultsbecause all the
dose levels right down to 1 gram triggered infection.
http://www.bseinquiry.gov.uk/files/ws/s147f.pdf
Re: BSE .1 GRAM LETHAL NEW STUDY SAYS via W.H.O. Dr Maura Ricketts
[BBC radio 4 FARM news]
http://www.maddeer.org/audio/BBC4farmingtoday2_1_03.ram
http://www.fda.gov/ohrms/dockets/ac/03/slides/3923s1_OPH.htm
2) Infectious dose:
To cattle: 1 gram of infected brain material (by oral ingestion)
http://www.inspection.gc.ca/english/sci/bio/bseesbe.shtml
TSS
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