| Comment Record |
|
Commentor |
Mr. Terry Singeltary |
Date/Time |
2003-01-15 13:55:02 |
|
Organization |
CJD WATCH |
|
Category |
Individual |
| Comments for FDA General |
| Questions |
|
1. General Comments
|
Re: Docket No. 02N-0273 – Substances Prohibited From Use In Animal Food Or Feed;
Greetings FDA and public,
we must ban _all_ ruminant-to-ruminant feeding and we _must_
ban all SRMs (specified risk materials) and MRMs
(mechanically recovered meats).
i find it very disturbing that in comments made by 'the industry';
> However, no new risks or science support the
> proposed changes set forth in the ANPR.
this is false. i don't suppose anyone from
the USDA/APHIS or the agencies and their corporations
below are even concerned that new science is indeed
forth coming, science they do not want to admit from
Collinge et al, that BSE transmission to the 129-methionine
genotype can lead to an alternate phenotype which is
indistinguishable from type 2 PrPSc, the commonest
sporadic CJD. how many of the sporadic CJDs in the USA
are type 2 PrpSc? please read this letter from Collinge et al;
Subject: re-BSE prions propagate as either variant CJD-like or
sporadic CJD
Date: Thu, 28 Nov 2002 10:23:43 -0000
From: Asante, Emmanuel A
To: 'flounder@wt.net'
Dear Terry,
I have been asked by Professor Collinge to respond to your request. I am a Senior Scientist in the MRC Prion Unit and the lead author on the paper. I have attached a pdf copy of the paper for your attention. Thank you for your interest in the paper.
In respect of your first question, the simple answer is, yes. As you will find in the paper, we have managed to associate the alternate phenotype to type 2 PrPSc, the commonest sporadic CJD.
It is too early to be able to claim any further sub-classification in
respect of Heidenhain variant CJD or Vicky Rimmer's version. It will take further studies, which are on-going, to establish if there are sub-types to our initial finding which we are now reporting. The main point of the paper is that, as well as leading to the expected new variant CJD phenotype, BSE transmission to the 129-methionine genotype can lead to an alternate phenotype which is indistinguishable from type 2 PrPSc.
I hope reading the paper will enlighten you more on the subject. If I can be of any further assistance please to not hesitate to ask. Best wishes.
Emmanuel Asante
<>
____________________________________
Dr. Emmanuel A Asante
MRC Prion Unit & Neurogenetics Dept.
Imperial College School of Medicine (St. Mary's)
Norfolk Place, LONDON W2 1PG
Tel: +44 (0)20 7594 3794
Fax: +44 (0)20 7706 3272
____________________________________
> In fact, several scientific studies have
> confirmed the fundamental soundness
and several scientific studies have confirmed the
USA BSE/TSE surveillance as terribly flawed, and one of
those groups was the GAO report, please see below, and please
read data on potential BSE/TSE/FMD 'SUITCASE BOMBS' and more
on that so-called 'triple firewall'. PLUS, the federal government
has ceased to make public ruminant-to-ruminant feed ban
violations since May 2001, now we must go through the FOIA.
i have pasted this data and a thread with USDA/APHIS officals
below;
Subject:
re-USA BSE/TSE RUMINANT-TO-RUMINANT FEED BAN VIOLATIONS ''cover-up''
From:
Terry S. Singeltary Sr.
Date:
Tue, 3 Dec 2002 15:16:58 -0600
To:
BSE-L
Greetings Dr. Gomez and other List members and Lurkers,
Gomez, Thomas M. wrote:
Subject: Re: Speaking Note on BSE Agriculture Council, Brussels, 2 8
November 2002 (compare TSE testing)
Date: Tue, 3 Dec 2002 10:21:41 -0500
From: Gomez, Thomas M.
Reply-To: BSE-L
> 1. I'm not able to comment on feed ban violations.
> Regulatory authority for Substances Prohibited From Use in
> Animal Food or Feed; Animal Proteins Prohibited in Ruminant
> Feed is the FDA, not the USDA.
snip...
thank you again Dr. Gomez, i did not realize you
could not speak about the ruminant-to-ruminant
feed ban. odd some FDA lurkers have not replied?
maybe Dr. Freas will know, but i don't think the
big guns lurk here. like Dr. Detwiler, she has her
other people do the dirty work here, replies through
them. odd, you replied about 50 State BSE Conference
call on Jan. 9, 2001, and that's pretty much all that
was about was all the BSE feed ban violations in the USA.
no matter, i will ask FDA officials.
Subject: USDA/APHIS response to BSE-L--U.S. 50 STATE CONFERENCE CALL
Jan. 9, 2001
Date: Wed, 10 Jan 2001 14:04:21 -0500
From: Gomez, Thomas M.
Reply-To: Bovine Spongiform Encephalopathy
USDA/APHIS would like to provide clarification on the following point
from Mr. Singeltary's 9 Jan posting regarding the 50 state conference call.
[Linda Detwiler asking everyone (me) not to use emergency BSE number,
unless last resort. (i thought of calling them today, and reporting the
whole damn U.S. cattle herd ;-) 'not']
Dr. Detwiler was responding to an announcement made during the call to
use the FDA emergency number if anyone wanted to report a cow with signs
suspect for BSE. Mr. Singeltary is correct that Dr. Detwiler asked
participants to use the FDA emergency number as a last resort to report
cattle suspect for BSE. What Mr. Singeltary failed to do was provide
the List with Dr. Detwiler's entire statement. Surveillance for BSE in
the United States is a cooperative effort between states, producers,
private veterinarians, veterinary hospitals and the USDA. The system
has been in place for over 10 years. Each state has a system in place
wherein cases are reported to either the State Veterinarian, the federal
Veterinarian in Charge or through the veterinary diagnostic laboratory
system. The states also have provisions with emergency numbers. Dr.
Detwiler asked participants to use the systems currently in place to
avoid the possibility of a BSE-suspect report falling through the
cracks. Use of the FDA emergency number has not been established as a
means to report diseased cattle of any nature...
snip...
FYI see full text with my reply here;
http://www.vegsource.com/talk/madcow/messages/8219.html
and a better reply than mine would be here;
>would you and the USDA/APHIS be so kind as to supply
>this list with a full text version of the conference
>call and or post on
>your web-site?
>if not, why not?
>
>> The system has been in place for over 10 years.
>
> only test 10,700 cattle from some 1.5 BILLION head (including
>calf crop). Especially since French >are testing some 20,000 weekly and
>the E.U. as a whole,
==-=-=
Right. The US has 101 million cows where as France has 5.7 million. This
being 17.7 as many cows, the US would need to test 17.7 x 20,000 =
354,386 cows a week to be testing proportionately. This compares to
about 50 cows a week tested now. In other words, the US needs to test
7,000 cows where it is now testing 1 to keep up with international norms.
Once a country starts serious testing, they get religion. After
stomaching some bad results, then they want their trading partners to
test just like they did.
No one can predict what, if anything, would turn up in the US from a
European scale of testing. Right now the US has not been using the
international gold standard of the Prionics test.
Just as Austria and Belgium have been forced into unwilling testing, the
US is going to have to test at an adequate level or forget about foreign
trade in bovine byproducts, cosmetics, nutriceuticals, veterinary
products, and pharmaceuticals. You can see this just from announcements
in Japan.
Nobody is going to buy into theoretical reasons why there shouldn't be
BSE in the US or Canada when the choice is real-world testing that
proved so informative in other theoretical countries such as Germany.
In my opinion, the US should have been preparing long ago for a soft
landing with the consumer instead of going with the heavy-handed
germanic denial system.
http://www.vegsource.com/talk/madcow/messages/8222.html
i 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 ???
for some humorist reading;
http://www.fda.gov/ohrms/dockets/dailys/01/Nov01/112901/01N-0423-EC-18.html
http://www.fda.gov/ohrms/dockets/dailys/01/Nov01/112901/01N-0423-EC-20.html
http://www.fda.gov/ohrms/dockets/dailys/01/Nov01/112901/01N-0423-EC-11.html
http://www.fda.gov/ohrms/dockets/dailys/01/Nov01/112901/01N-0423-EC-19.html
http://www.fda.gov/OHRMS/DOCKETS/98fr/100501b.htm
http://www.access.gpo.gov/nara/cfr/waisidx_01/21cfr589_01.html
snip...
As of March 11, CVM had received inspection reports covering inspections
(both initial inspections and re-inspections) of 10,458 different firms.
The majority of these inspections (around 80%) were conducted by State
officials under contract to FDA and the remainder by FDA officials.
Various segments of the feed industry had different levels of compliance
with this feed ban regulation. The results to date are reported here
both by segment of industry and in total.
RENDERERS
(These firms are the first to handle rendered protein and send materials
to feed mills and ruminant feeders.)
*
NUMBER OF FIRMS WHOSE INITIAL INSPECTION HAS BEEN REPORTED TO CVM
- 239
*
NUMBER OF FIRMS HANDLING MATERIALS PROHIBITED FOR USE IN RUMINANT
FEED - 171 (72% of those firms inspected/reported).
* Of the 171 renderers handling prohibited materials, at their most
recent inspection (could have been an initial or a follow-up inspection):
- 4 (2%) had products that were not labeled as required
- 3 (2%) did not have adequate systems to prevent co-mingling
- 1 (1%) did not adequately follow record keeping regulations
- 4 (2%) firms were found to be out of compliance (some firms
were out of compliance with more than one aspect of the rule)
FDA LICENSED FEED MILLS
(FDA licenses these mills to produce medicated feed products. This
licensing has nothing to do with handling prohibited materials under the
feed ban rule: 21 CFR 589.2000. A license from FDA is not required to
handle materials prohibited under 21 CFR 589.2000.)
*
NUMBER OF FIRMS WHOSE INITIAL INSPECTION HAS BEEN REPORTED TO CVM
- 1,203
*
NUMBER OF FIRMS HANDLING MATERIALS PROHIBITED FOR USE IN RUMINANT
FEED - 370 (31% of those firms inspected/reported)
* Of the 370 licensed feed mills handling prohibited materials, at
their most recent inspection (could have been an initial or a follow-up
inspection):
- 8 (2%) had products that were not labeled as required
- 2 (1%) did not have adequate systems to prevent co-mingling
- 3 (1%) did not adequately follow record keeping regulations
- 10 (3%) firms were found to be out of compliance (some firms
were out of compliance with more than one aspect of the rule)
FEED MILLS NOT LICENSED BY FDA
*
NUMBER OF FIRMS WHOSE INITIAL INSPECTION HAS BEEN REPORTED TO CVM
- 4,867
*
NUMBER OF FIRMS HANDLING MATERIALS PROHIBITED FOR USE IN RUMINANT
FEED - 1,224 (25% of those firms inspected/reported)
* Of the 1,224 feed mills not licensed by FDA handling prohibited
materials, at their most recent inspection (could have been an initial
or a follow-up inspection):
- 55 (4%) had products that were not labeled as required
- 28 (2%) did not have adequate systems to prevent co-mingling
- 28 (2%) did not adequately follow record keeping regulations
- 86 (7%) firms were found to be out of compliance (some firms
were out of compliance with more than one aspect of the rule)
OTHER FIRMS INSPECTED
(Examples of such firms include: ruminant feeders, on-farm mixers,
protein blenders, and distributors.)
*
NUMBER OF FIRMS WHOSE INITIAL INSPECTION HAS BEEN REPORTED TO CVM
- 4,710
*
NUMBER OF FIRMS HANDLING MATERIALS PROHIBITED FOR USE IN RUMINANT
FEED - 565 (12% of those firms inspected/reported)
* Of the 565 such firms handling prohibited materials, at their
most recent inspection (could have been an initial or a follow-up
inspection):
- 17 (3%) had products that were not labeled as required
- 2 (less than 1%) did not have adequate systems to prevent
co-mingling
- 7 (1%) did not adequately follow record keeping regulations
- 25 (4%) firms were found to be out of compliance (some firms
were out of compliance with more than one aspect of the rule)
TOTALS (as of March 11, 2002)
*
NUMBER OF FIRMS WHOSE INITIAL INSPECTION HAS BEEN REPORTED TO CVM
- 10,458
*
NUMBER OF FIRMS HANDLING MATERIALS PROHIBITED FOR USE IN RUMINANT
FEED - 2,153 (21% of those firms inspected/reported)
* Of the 2,153 firms handling prohibited materials, at their most
recent inspection (could have been an initial or a follow-up inspection):
- 77 (4%) had products that were not labeled as required
- 34 (2%) did not have adequate systems to prevent co-mingling
- 35 (2%) did not adequately follow record keeping regulations
- 113 (5%) firms were found to be out of compliance
RE-INSPECTIONS
When firms are found to be out of compliance with the feed ban rule, FDA
lists them for a re-inspection. As of March 11, 2002, reports of 2,185
re-inspections have been submitted to CVM. On re-inspection of these
2,185 firms, 32 (1%) were found still to be out of compliance with this
rule. Firms previously found to be not in compliance have corrected
problems through a variety of ways, including further training of
employees about the rule, developing systems to prevent co-mingling,
re-labeling their products properly, and adhering to record keeping
regulations. Other firms have achieved compliance by eliminating
prohibited materials from their operations.
DATABASE CHANGE
After March 11, 2002, FDA discontinued the database that was used to
compile these numbers. The Agency is starting a new database on April
15, 2002, and future updates on BSE enforcement will draw from it.
snip...
http://www.fda.gov/cvm/index/fdavet/2002/May_June.htm#Ruminant
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?
USA 8/4/97 RUMINANT-TO-RUMINANT FEED BAN that never was...
'ANIMAL PROTEIN' SEARCH 9/9/02
==============================
Darling International, Inc.
5/07/02
Seattle District Office Animal Proteins Prohibited in Ruminant
Feed/Misbranded [PDF]
[HTML] All American Feed & Tractor
4/01/02
Seattle District Office Animal Proteins Prohibited in Ruminant
Feed/Adulterated [PDF]
[HTML] Tyson Foods
2/12/02
Seattle District Office Animal Proteins Prohibited in Ruminant
Feed/Misbranded [PDF]
[HTML] The Feed Bucket
12/11/01
Atlanta District Office Animal Proteins Prohibited in Ruminant
Feed/Adulterated/Misbranded [PDF]
[HTML] Finlayson Ag Center
11/08/01
Minneapolis District Office Animal Proteins Prohibited in Ruminant
Feed/Adulterated [PDF]
[HTML] Dixon Feeds, Inc.
10/24/01
Seattle District Office Animal Proteins Prohibited in Ruminant
Feed/Adulterated [PDF]
[HTML] Buckeye Feed Mills, Inc.
9/20/01
Cincinnati District Office Animal Proteins Prohibited in Ruminant
Feed/Adulterated/Misbranded [PDF]
[HTML] Wilcox Farms, Inc.
9/14/01
Seattle District Office Animal Proteins Prohibited in Ruminant Feed [PDF]
[HTML]
http://www.accessdata.fda.gov/scripts/wlcfm/full_text.cfm?full_text=animal+protein&Search=Search
now, compare search on 8/8/01...tss
===================================
'ANIMAL PROTEIN' SEARCH 8/8/01
==============================
Date: Tue, 28 Aug 2001 11:13:43 -0700
Reply-To: BSE-L
Sender: Bovine Spongiform Encephalopathy BSE-L
From: Terry S. Singeltary Sr.
Subject: MAD COW FEED BAN WARNING LETTERS U.S.A. AUGUST 8, 2001
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Seattle District Pacific Region 22201 23rd Drive SE Bothell, WA 98021-4421
Telephone: 426-486-8788 FAX: 426-483-4996
August 8, 2001
VIA CERTIFIED MAIL RETURN RECEIPT REQUESTED
In reply refer to Warning Letter SEA 01-75
William W. Himmelspach, Owner 22195 S.W. 78th Tualatin, Oregon 97062
WARNING LETTER
Dear Mr. Himmelspach:
An investigation at your animal feed manufacturing operation located at
22195 S.W. 78th Tualatin, Oregon 97062, conducted by a Food and Drug
Administration investigator on July 12, 2001, found significant
deviations from the requirements set forth in Title 21, Code of Federal
Regulations, Part 589.2000 - Animal Proteins Prohibited in Ruminant
Feed. The regulation is intended to prevent the establishment and
amplification of Bovine Spongiform Encephalopathy (BSE). Such deviations
cause products being manufactured at this facility to be adulterated
within the meaning of Section 402(a)(2)(C), and 402(a)(4) of the Federal
Food, Drug and Cosmetic Act (the Act).
Our investigation found a failure to separate the receipt, processing,
and storage of the product containing prohibited material from
non-prohibited material; failure to establish a written system,
including clean-out and flushing procedures, to avoid commingling and
cross-contamination of common equipment; and failure to maintain records
sufficient to track the materials throughout the receipt, processing,
and distribution of your products.
In addition, our investigation found a failure to label your products
with the required cautionary, statement Do Not Feed to Cattle or Other
Ruminants, Your pig feeds, containing prohibited materials, were not
labeled with the cautionary statement, and you reuse poly-tote bags for
ruminant feed and pig feed, where the bags could become contaminated
with prohibited material. The FDA suggests the statement be
distinguished by different type size or color or other means of
highlighting the statement so that it is easily noticed by a purchaser.
The above is not intended to be an all-inclusive list of deviations from
the regulations. As a manufacturer of materials intended for animal feed
use, you are responsible for assuring that your overall operation and
the products you manufacture and distribute are in compliance with
William W. Himmelspach Tualatin, Oregon Re: Warning Letter SEA 01-75 Page 2
your overall operation and the products you manufacture and distribute
are in compliance with the law. We have enclosed a copy of the FDA's
Small Entity Compliance Guide to assist you with complying with the
regulation.
You should take prompt action to correct these violations, and you
should establish a system whereby such violations do not recur. Failure
to promptly correct these violations may result in regulatory action
without further notice, such as seizure and/or injunction.
You should notify this office in writing within 15 working days of
receipt of this letter, of the steps you have taken to bring your firm
into compliance with the law. Your response should include an
explanation of each step being taken to correct the violations, and
prevent their recurrence. If corrective action cannot be completed in 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 that corrections have been made.
Your reply should be directed to the Food and Drug Administration,
Attention: Bruce Williamson, Compliance Officer. If you have any
questions please contact Mr. Williamson at (425) 483-4976.
Sincerely,
Charles M. Breen District Director
Enclosure; Form FDA 483 Small Entity Compliance Guide
http://www.fda.gov/foi/warning_letters/g1619d.pdf
Warning Letters Index - Search Form Results Company Name Date Issued
Issuing Office
Subject
File Adrian Elevator, Inc. 5/03/01 Minneapolis District Office Animal
Proteins Prohibited in Ruminant Feed
View File Alaska Garden and Pet Supply, Inc. 4/27/01 Seattle District
Office Animal Proteins Prohibited in Ruminant Feed
View File Bryan Enterprises 2/20/01 Cincinnati District Office Feed
Mill/Animal Proteins Prohibited in Ruminant Feed/Adulterated
View File Carrollton Farmers Exchange 7/12/01 Cincinnati District Office
Animal Proteins Prohibited in Ruminant Feed
View File Centerburg Mill and General Store, Inc 3/23/01 Cincinnati
District Office Animal Proteins Prohibited in Ruminant Feed
View File Centerburg Mill and General Store, Inc. 5/23/01 Cincinnati
District Office Animal Proteins Prohibited in Ruminant Feed
View File Central Ohio Farmers Cooperative, Inc. 5/24/01 Cincinnati
District Office Animal Protein Prohibited in Ruminant Feed
View File Champaign Landmark, Inc. 3/05/01 Cincinnati District Office
Animal Proteins Prohibited in Ruminant Feed/Misbranded
View File Countryline Co-Op, Inc. 5/14/01 Cincinnati District Office
Animal Proteins Prohibited in Ruminant Feed
View File Dorset Milling 4/16/01 Cincinnati District Office Animal
Proteins Prohibited in Ruminant Feed
View File Earl B. Olson Feed Mill 4/23/01 Minneapolis District Office
Animal Proteins Prohibited in Ruminant Feed
View File Faler Feed Store, Inc. 3/21/01 Cincinnati District Office
Animal Proteins Prohibited in Ruminant Feed
View File Farmers Mill & Elevator Company 3/30/01 Atlanta District
Office Animal Proteins Prohibited in Ruminant Feed
View File Farnam Companies, Inc. 7/20/01 Kansas City District Office
Animal Proteins Prohibited in Ruminant Feed/Adulterated
View File Greeley Elevator Company 4/04/01 Denver District Office Animal
Proteins Prohibited in Ruminant Feed
View File Hartville Elevator Company, Inc. 2/22/01 Cincinnati District
Office Feed Mill/Animal Proteins Prohibited in Ruminant Feed/Adulterated
View File Himmelspach, William W. 8/08/01 Seattle District Office Animal
Proteins Prohibited in Ruminant Feed
View File Integral Fish Foods, Inc. 6/12/01 Denver District Office
Animal Proteins Prohibited in Ruminant Feed
View File Jefferson Milling Company 4/16/01 Cincinnati District Office
Animal Proteins Prohibited in Ruminant Feed
View File Lime Creek Ag Services, Inc. 4/25/01 Minneapolis District
Office Animal Proteins Prohibited in Ruminant Feed
View File Material Resources LLC 5/04/01 Chicago District Office Animal
Proteins Prohibited in Ruminant Feed
View File Material Resources, LLC 5/04/01 Chicago District Office Animal
Protein Prohibited in Ruminant Feed
View File Medina Landmark, Inc. 3/23/01 Cincinnati District Office
Animal Proteins Prohibited in Ruminant Feed
View File Minister Farmers Cooperative Exchange, Inc. 4/10/01 Cincinnati
District Office Animal Proteins Prohibited in Ruminant Feed/Feed Mill
View File Peco Foods, Inc. 2/23/01 New Orleans District Office CGMP
Requirements for Medicated Feeds/Animal Proteins Prohibited in Ruminant Feed
View File Perry Coal and Feed Company 4/16/01 Cincinnati District Office
Animal Proteins Prohibited in Ruminant Feed
View File Rietdyk's Milling Company 3/05/01 Seattle District Office
Animal Proteins Prohibited in Ruminant Feed
View File River Valley Co-Op 3/22/01 Cincinnati District Office Animal
Proteins Prohibeted in Ruminant Feed
View File River Valley Co-Op 5/22/01 Cincinnati District Office Animal
Proteins Prohibited in Ruminant Feed
View File Round Lake Farmers Coop. 5/30/01 Minneapolis District Office
Animal Proteins Prohibited in Ruminant Feed
View File Rudy, Inc. 3/22/01 Cincinnati District Office Animal Proteins
Prohibited in Ruminant Feed
View File Rudy, Inc. 5/22/01 Cincinnati District Office Animal Proteins
Prohibited in Ruminant Feed
View File Sandy Lake Mills 4/09/01 Philadelphia District Office Animal
Proteins Prohibited in Ruminant Feed
View File Shields Feed and Supply Company 3/07/01 New Orleans District
Office Animal Proteins Prohibited in Ruminant Feed
View File Stewart's Farm Supply 3/21/01 Cincinnati District Office
Animal Proteins Prohibited in Ruminant Feed
View File Superior Feeds 6/06/01 Seattle District Office Animal Proteins
Prohibited in Ruminant Feed
View File The Scoular Company 5/30/01 Minneapolis District Office Animal
Proteins Prohibited in Ruminant Feed
View File University of Minnesota 5/10/01 Minneapolis District Office
Animal Proteins Prohibited in Ruminant Feed
View File Valley Feed Mill, Inc. 5/22/01 Cincinnati District Office
Animal Proteins Prohibited in Ruminant Feed
View File Wallowa County Grain Growers, Inc. 5/17/01 Seattle District
Office Animal Proteins Prohibited in Ruminant Feed
View File Wallowa County Grain Growers, Inc. 5/17/01 Seattle District
Office Animal Proteins Prohibited in Ruminant Feed
View File Western Reserve Farm Cooperative 3/21/01 Cincinnati District
Office Animal Protein Prohibited in Ruminant Feed
View File Yachere Feed, Inc. 4/09/01 Philadelphia District Office Animal
Proteins Prohibited in Ruminant Feed
View File Z & W Mill, Inc. 3/27/01 Denver District Office Animal
Proteins Prohibited in Ruminant Feed
View File
http://63.75.126.221/scripts/wlcfm/resultswl.cfm
(TYPE IN 'ANIMAL PROTEIN')
we must not forget the ANIMAL PROTEIN FED TO DEER/ELK.
those warning letters were stopped long ago;
Subject: MAD DEER/ELK DISEASE AND POTENTIAL SOURCES
Date: Sat, 25 May 2002 18:41:46 -0700
From: Terry S. Singeltary Sr.
Reply-To: BSE-L
To: BSE-L
8420-20.5% Antler Developer
For Deer and Game in the wild
Guaranteed Analysis Ingredients / Products Feeding Directions
snip...
_animal protein_
http://www.surefed.com/deer.htm
BODE'S GAME FEED SUPPLEMENT #400
A RATION FOR DEER
NET WEIGHT 50 POUNDS
22.6 KG.
snip...
_animal protein_
http://www.bodefeed.com/prod7.htm
Ingredients
Grain Products, Plant Protein Products, Processed Grain By-Products,
Forage Products, Roughage Products 15%, Molasses Products,
__Animal Protein Products__,
snip...
http://www.bodefeed.com/prod6.htm
===================================
MORE ANIMAL PROTEIN PRODUCTS FOR DEER
Bode's #1 Game Pellets
A RATION FOR DEER
F3153
GUARANTEED ANALYSIS
Crude Protein (Min) 16%
Crude Fat (Min) 2.0%
snip...
Ingredients
Grain Products, Plant Protein Products, Processed Grain By-Products,
Forage Products, Roughage Products, 15% Molasses Products,
__Animal Protein Products__,
Monocalcium Phosphate, Dicalcium Phosphate, Salt,
snip...
FEEDING DIRECTIONS
Feed as Creep Feed with Normal Diet
http://www.bodefeed.com/prod8.htm
INGREDIENTS
Grain Products, Roughage Products (not more than 35%), Processed Grain
By-Products, Plant Protein Products, Forage Products,
__Animal Protein Products__,
L-Lysine, Calcium Carbonate, Salt, Monocalcium/Dicalcium
snip...
DIRECTIONS FOR USE
Deer Builder Pellets is designed to be fed to deer under range
conditions or deer that require higher levels of protein. Feed to deer
during gestation, fawning, lactation, antler growth and pre-rut, all
phases which require a higher level of nutrition. Provide adequate
amounts of good quality roughage and fresh water at all times.
http://www.profilenutrition.com/Pro...er_pellets.html
DEPARTMENT OF HEALTH & HUMAN SERVICES
PUBLIC HEALTH SERVICE
FOOD AND DRUG ADMINISTRATION
April 9, 2001 WARNING LETTER
01-PHI-12
CERTIFIED MAIL
RETURN RECEIPT REQUESTED
Brian J. Raymond, Owner
Sandy Lake Mills
26 Mill Street
P.O. Box 117
Sandy Lake, PA 16145
PHILADELPHIA DISTRICT
Tel: 215-597-4390
Dear Mr. Raymond:
Food and Drug Administration Investigator Gregory E. Beichner conducted
an inspection of your animal feed manufacturing operation, located in
Sandy Lake, Pennsylvania, on March 23, 2001, and determined that your
firm manufactures animal feeds including feeds containing prohibited
materials. The inspection found significant deviations from the
requirements set forth in Title 21, code of Federal Regulations, part
589.2000 - Animal Proteins Prohibited in Ruminant Feed. The regulation
is intended to prevent the establishment and amplification of Bovine
Spongiform Encephalopathy (BSE) . Such deviations cause products being
manufactured at this facility to be misbranded within the meaning of
Section 403(f), of the Federal Food, Drug, and Cosmetic Act (the Act).
Our investigation found failure to label your swine feed with the
required cautionary statement Do Not Feed to cattle or other Ruminants
The FDA suggests that the statement be distinguished by different
type-size or color or other means of highlighting the statement so that
it is easily noticed by a purchaser.
In addition, we note that you are using approximately 140 pounds of
cracked corn to flush your mixer used in the manufacture of animal
feeds containing prohibited material. This flushed material is fed to
wild game including deer, a ruminant animal. Feed material which may
potentially contain prohibited material should not be fed to ruminant
animals which may become part of the food chain.
The above is not intended to be an all-inclusive list of deviations from
the regulations. As a manufacturer of materials intended for animal
feed use, you are responsible for assuring that your overall operation
and the products you manufacture and distribute are in compliance with
the law. We have enclosed a copy of FDA's Small Entity Compliance Guide
to assist you with complying with the regulation... blah, blah, blah...
http://www.fda.gov/foi/warning_letters/g1115d.pdf
===================================================
now, what about those 'deer scents' of 100% urine',
and the prion that is found in urine, why not just
pass the prion with the urine to other deer...
Mrs. Doe Pee Doe in Estrus
Model FDE1 Mrs. Doe Pee's Doe in Estrus is made from Estrus urine
collected at the peak of the rut, blended with Fresh Doe Urine for an
extremely effective buck enticer. Use pre-rut before the does come into
heat. Use during full rut when bucks are most active. Use during
post-rut when bucks are still actively looking for does. 1 oz.
http://www.gamecalls.net/huntingproducts/deerlures.html
ELK SCENT/SPRAY BOTTLE
*
Works anytime of the year
*
100 % Cow Elk-in-Heat urine (2oz.)
*
Economical - mix with water in spray mist bottle
*
Use wind to your advantage
Product Code WP-ESB $9.95
http://www.elkinc.com/Scent.asp
prions in urine?
[PDF] A URINE TEST FOR THE IN-VIVO DIAGNOSIS OF PRION DISEASES
http://www.sigov.si/vurs/PDF/diagnoastika-bse-urin.pdf
Subject: Meat and Poultry: Better USDA Oversight and Enforcement of Safety
Date: Thu, 19 Sep 2002 14:17:59 -0700
From: Terry S. Singeltary Sr.
Reply-To: BSE-L
To: BSE-L
3. Meat and Poultry: Better USDA Oversight and Enforcement of Safety
Rules Needed to Reduce Risk of Foodborne Illnesses. GAO-02-902, August
30.
FSIS Is Not Ensuring that Plants' HACCP Plans Meet Regulatory
Requirements
snip...
According to FSIS's food safety systems correlation reviews, inspectors
are not consistently identifying and documenting failures of plants'
HACCP plans to meet regulatory requirements. Furthermore, FSIS does
not expect its inspectors to determine whether HACCP plans are based on
sound science--the cornerstone of an effective plan. While in-depth
verification reviews examine the scientific aspects of HACCP plans, they
have been conducted in very few plants, and consumer safety officers
hired to review the scientific soundness of HACCP plans may take several
years to assess the plans at all plants. Moreover, inspectors in 55
percent of the 5,000 plants nationwide did not document any HACCP
violations during fiscal year 2001. When we brought this information to
the attention of FSIS officials, they were surprised that so many plants
had no HACCP violations for an entire year.
snip...
2. USDA believes that the title of the report is misleading. We
disagree. We believe the title accurately reflects the concerns detailed
throughout the body of the report.
snip...
http://www.gao.gov/cgi-bin/getrpt?GAO-02-902
Subject: GAO ''BLASTS'' USA FDA HALF-ASS MAD COW FEED BAN RULES (or the
lack of)
Date: Tue, 26 Feb 2002 11:29:57 -0800
From: Terry S. Singeltary Sr.
Reply-To: BSE-L
To: BSE-L
Investigators: FDA Lax on Mad Cow
Tue Feb 26,11:37 AM ET
By PHILIP BRASHER, AP Farm Writer
WASHINGTON - The Food and Drug Administration (news - web sites ) has
failed to properly enforce its restrictions on animal feed that are
intended to keep mad-cow disease from spreading if it ever gets into the
country, congressional investigators say.
Feed mills and other firms that violate the rules are seldom punished,
and FDA has never even identified all the businesses that should be
inspected, the General Accounting Office (news - web sites) said in a
report released Tuesday.
The report also raises concerns about import controls that are supposed
to keep infected meat and other material from entering the country
The continuing absence of (mad cow disease) in the United States today
cannot be sufficiently ensured by current federal prevention efforts,
the report said.
The agency outlawed the feeding of mammalian meat and bone meal to
cattle, sheep and goats in 1997 and imposed a series of rules to ensure
that feed mills comply with the ban.
Animals are believed to get the brain-wasting disease, formally known as
bovine spongiform encephalopathy (news - web sites ), through eating the
brain or nervous system tissue from diseased animals. Meat and bone meal
has long been added to animal feed as a protein supplement.
The disease has never been found in the United States but has devastated
the beef industry in Europe and spread to Japan.
An FDA spokesman had no immediate comment Tuesday on the GAO report. In
a letter to the investigators, however, FDA said it is correcting
problems in its inspection system. Improvements in the system will make
the present small risk of introduction and spread (of mad-cow disease
even smaller, the agency said.
The food industry became alarmed last year about the problems FDA was
having enforcing the rules and began requiring meat processors to
certify that the cattle were not given prohibited feed. Slaughterhouses,
in turn, started requiring similar paperwork from their cattle suppliers.
The congressional investigators said the nature and severity of the
problem in FDA's enforcement of the feed ban point to insufficient
attention by FDA management.
The report also says that the Agriculture Department is testing too few
cattle for the disease. USDA plans to increase its testing from 5,000 to
12,500 cattle a year.
Sen. Richard Durbin (news ), D-Ill., who requested the GAO report along
with Senate Agriculture Committee Chairman Tom Harkin of Iowa and the
panel's ranking Republican, Richard Lugar of Indiana, plans to introduce
legislation to tighten federal regulation of animal feed and meat
processing.
Patrick Boyle, president of the American Meat Institute, said the GAO
report misinterprets, or simply ignores the effectiveness of measures
already taken by the government.
http://story.news.yahoo.com/news?tm...pe/us_mad_cow_3
FULL TEXT OF GOA REPORT BELOW (takes a while to load)
2. Mad Cow Disease: Improvements in the Animal Feed Ban and Other
Regulatory Areas Would Strengthen U.S. Prevention Efforts. GAO-02-183,
January 25.
http://www.gao.gov/cgi-bin/getrpt?GAO-02-183
i will patiently await a reply from FDA lurkers about this
serious matter for public awareness...
kind regards,
Terry S. Singeltary Sr., Bacliff, Texas USA
=============================================
Subject: USA BSE/TSE RUMINANT-TO-RUMINANT FEED BAN VIOLATIONS ''cover-up''
From: Terry S. Singeltary Sr.
Date: Mon, 2 Dec 2002 11:17:40 -0600
To: BSE-L
Greetings List members,
i have tried to inquire about the USA BSE/TSE feed ban
violations with no luck via USDA/APHIS. since about april
or may of 2002, the warning letters have ceased to be posted
publicly, and at the site CVM and Ruminant feed inspections
site url, they have not been updated either. it seems to
me the new administration has taken away all rights for
the public to view these violations.
where are they now being posted ???
you can hide it, but it will not make it go away.
would/could the USDA/APHIS whom lurk on this list,
please comment?
http://www.fda.gov/cvm/efoi/InpectionListDescriptionforHP.htm
http://www.testcowsnow.com
GBR risk assessment of BSE should be changed to all TSEs.
USA GBR II should be changed to GBR III immediately!
now about those ruminant-to-ruminant feed ban violations
that have ceased to be published? why you may ask?
Subject: Re: USA ruminant-to-ruminant feed ban warning letters ???
Date: Mon, 13 Jan 2003 15:08:13 -0600
From: Terry S. Singeltary Sr.
Reply-To: Bovine Spongiform Encephalopathy
To: BSE-L
References: <3E075C47.3080506@wt.net> <3E21BA6C.3040900@wt.net> <3E23107A.433C64BF@airtime.co.uk>
hello Dr. Dealler,
please do not hold your breath for any USA
ruminant-to-ruminant feed ban warning letters
since May of 2002 to be released anytime soon,
this could be fatal for you;-)
i have not gotten them yet, if any exist.
but i am trying.
hopefully GW et al will not think i am one of
the terrorist, and will allow for this information
to be released (with no charge attached$$$)...
kindest regards,
terry
Steve Dealler wrote:
> This was absolutely excellent for Terry to have got this from the US
> Government...you should have tried getting this sort of thing from MAFF in the UK
> at the beginning of the nineties!
> Steve Dealler
>
> Terry S. Singeltary Sr. wrote:
>
>
>>
>>Greetings List Members,
>>
>>as you know, i finally had to request to the FOIA
>>for the USA madcow feed ban warning letters. so i thought
>>some of you may be interested in an update on this matter.
>>
>>so here it is;
>>
>>Subject: Request to FDA via FOIA of ALL USA Ruminant-to-Ruminant Feed
>>Ban Violations Jan. 2001 to Jan. 2003
>>Date: Mon, 6 Jan 2003 08:32:43 -0600
>>From: Terry S. Singeltary Sr.
>>Reply-To: Bovine Spongiform Encephalopathy
>>To: BSE-L
>>
>>Food and Drug Administration
>>Office of Information Resources Management
>>Division of Freedom of Information (HFI-35)
>>5600 Fishers Lane
>>Rockville, MD 20857
>>
>>Or requests may be sent via fax to: (301) 443-1726. If there are
>>problems sending a fax, call (301) 443-2414.
>>
>>1/6/03
>>
>>Request to FDA via FOIA of ALL USA Ruminant-to-Ruminant Feed Ban
>>Violations Jan. 2001 to Jan. 2003
>>
>>Greetings FDA and To Whom it may concern,
>>
>>i wish to request all ruminant-to-ruminant feed ban violations from Jan.
>>2001 to Jan. 2003. it seems none has been posted since May 2001 on the
>>FDA site. I also kindly request that all fees be wavered due to the fact
>>this is public information, public health is at risk, and this
>>will be distributed 'freely' to the public...
>>
>>thank you,
>>kind regards,
>>
>>I am sincerely,
>>
>>Terry S. Singeltary Sr.
>>P.O. Box Bacliff, Texas USA 77518
>>CJD Watch
>>http://www.fortunecity.com/healthclub/cpr/349/part1cjd.htm
>>==========================================================
>>
>>now since then, just this past Friday 1/10/03, i get this from
>>FDA;
>>
>>REPLY FROM DPH/FDA to TSS;
>>
>>PLEASE note, my request was for all R-T-R feed ban
>>violations from Jan. 2001 to Jan. 2003. BUT in the
>>reply, they posted Jan. 2002 to Jan. 2003. i called
>>and this is to be corrected. hopefully this FOIA
>>request will ignite some enthusiasm from the FDA
>>into posting to the public any R-T-R MAD COW
>>FEED BAN violations, since GW et al new policy
>>on secrecy took effect on this matter in May of 2002
>>(correcting my below 'since May 2001).
>>
>>TSS
>>
>>Department of Health & Human Services
>>
>>Food and Drug Administration
>>Rockville MD 20857
>>
>>1/7/03
>>
>>In reply refer to;
>>
>>xxxxxxx
>>
>>Dear Requester,
>>
>>The Food and Drug Administration (FDA) has received your
>>Freedom of Information Act (FOIA) request for records
>>regarding;
>>
>>RUMINANT-TO-RUMINANT FEED - BAN VIOLATIONS 1/02 - 1/03
>>
>>We will respond as soon as possible and may charge you a fee
>>for processing your request. If you have any questions
>>about your request, please call Edna G. Wilkerson,
>>Information Technician, at 301-827-6564 or write to us
>>at;
>>
>>Food and Drug Administration
>>Division of Freedom of Information
>>5600 Fishers Lance, HFI - 35
>>Rockville, MD 20857
>>
>>If you call or write, use the reference number above
>>which will help us to answer your questions more quickly...
>>===========================================================
>>now, Sunday, i read this in the Houston Chronicle 1/12/03;
>>
>>SENATOR AIMS TO UPGRADE FREEDOM OF INFORMATION
>>
>>TEXAS Sen. John Coprnyn says he wants to improve public access to
>>government records in Washington, a position that appears to put
>>him at odds with the Bush administration.
>>
>>Cornyn, a moderate Republican who sits on the Senate Judiciary
>>Committee, said he'll work on legislation in the coming weeks to
>>improve the Freedom of Information Act.
>>
>>FOIA needs to be strenghened, he said, We need to quicken the
>>turnaround time and create a mechanism that allows an indepentent,
>>third party to decide whether a record should be kept secret.
>>
>>Echoing sentiments he expressed while serving as Texas attorney
>>general, Cornyn added: I believe in a system of governement
>>that allows consent of the people. And people can't consent if they
>>don't what their elected officials are doing.
>>
>>Since taking office two years ago, the Bush Administration has
>>taken steps to restrict access to governement information, an effort
>>that was accelerated in the name of national security following
>>the Sept. 11 terrorist attacks......
>>
>>Greetings again BSE-L list members,
>>
>>how would _USA_ ruminant-to-ruminant feed ban warning
>>letters have anything to do with terrorism and National
>>Security?
>>
>>you can see a list of sample USA madcow warning letters;
>>
>>http://www.vegsource.com/talk/madcow/messages/9912238.html
>>
>>FYI, please see a bit of history on this topic;
>>
>>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...
>>
>>Food and Drug Administration Kansas City District Southwest Region 11630
>>West 60 Street P.O. Box 15905 Lenexa, Kansas 66265-4905 Telephone: (913)
>>752-2100
>>
>>July 29, 2002 CERTIFIED MAIL RETURN RECEIPT REQUESTED WARNING LETTER
>>Ref. KAN 2002-09
>>
>>Jerry Behimer, Owner Bakery Trading Company/Ingredient Exchange 401 N.
>>Lindbergh Blvd., Suite 315 St. Louis, MO 63141-7816
>>
>>Dear Mr. Behimer:
>>
>>An inspection of your animal feed premix-manufacturing operations,
>>located at 14521 2nd Ave., Ottumwa, Iowa, was conducted by an
>>Investigator from our office on June 18 & 19, 2002. During this
>>inspection, a significant deviation from the requirements set forth in
>>Title 21, Code of Federal Regulations, Part 589.2000 - Animal Proteins
>>Prohibited in Ruminant Feed was identified. The regulation is intended
>>to prevent the establishment and amplification of Bovine Spongiform
>>Encephalopathy (BSE). Under 21 C.F.R. 589.2000(g)(2), such a deviation
>>causes products being manufactured and/or distributed by your facility
>>to be deemed misbranded within the meaning of Section 403(a)(l) of the
>>Federal Food, Drug, and Cosmetic Act (the Act), and these products may
>>not be lawfully introduced, or delivered for introduction, into
>>interstate commerce.
>>
>>Our investigation found a failure to label your Powdered Cooked Beef,
>>Product No. 5013, produced during the period of 2/13/02 to approximately
>>4/18/02, with the cautionary statement Do Not Feed to Cattle or Other
>>Ruminants, as required by 21 C.F.R. 589.2000(d). The FDA suggests the
>>statement be distinguished by different type size or color, or other
>>means of highlighting the statement so that it is easily noticed by a
>>purchaser.
>>
>>The above is not intended to be an all-inclusive list of deviations from
>>the regulations. As a manufacturer of materials intended for animal feed
>>use, 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 these violations may result in regulatory action
>>without further notice, such as seizure and/or injunction.
>>
>>It is necessary for you to take action on this matter now. We request
>>you provide our office documentation of corrective action and final
>>disposition for Lot 030402, approximately 21 tons, which was on hand
>>during the inspection. Let this office know in writing within fifteen
>>(15) working days from the date you received this letter what steps you
>>are taking to correct the problem.
>>
>>Your reply should be sent to Nadine Nanko Johnson, Compliance Officer,
>>at the above address.
>>
>>Sincerely,
>>
>>/s/
>>
>>Charles W. Sedgwick
>>
>>District Director
>>
>>Kansas City District
>>
>>http://www.fda.gov/foi/warning_letters/g3430d.htm
>>
>>Food and Drug Administration Seattle District Pacific Region 22201 23rd
>>Drive SE Bothell, WA 98021-4421 Telephone: 425-466-6766 FAX: 426-483-4996
>>
>>May 7, 2002 CERTIFIED MAIL RETURN RECEIPT REQUESTED In reply refer to
>>Warning Letter SEA 02-46 WARNING LETTER
>>
>>Mr. Philip C. Anderson, General Manager Darling International, Inc. 2041
>>Marc Avenue Tacoma, Washington 98401
>>
>>Dear Mr. Anderson:
>>
>>An inspection of your rendering operation conducted by Investigator
>>Donald B. McKechnie, on February 22 and 26, 2002, found a significant
>>deviation from the requirements set forth in Title 21, Code of Federal
>>Regulations, Part 589.2000 - Animal Proteins Prohibited in Ruminant
>>Feed. The regulation is intended to prevent the establishment and
>>amplification of Bovine Spongiform Encephalopathy (BSE). Such deviation
>>causes products being manufactured and/or distributed by your facility
>>to be misbranded within the meaning of Section 403(f) of the Federal
>>Food, Drug, and Cosmetic Act (the Act).
>>
>>Our investigation found a failure to consistently label your meat and
>>bone meal product shipped to [redacted], with the required cautionary
>>statement Do Not Feed to Cattle or Other Ruminants. The meat and bone
>>meal contains beef offal along with other ingredients including chicken,
>>fish, and pork. The FDA suggests the statement be distinguished by
>>different type size or color or other means of highlighting the
>>statement so that it is easily noticed by a purchaser.
>>
>>The above is not intended to be an all-inclusive list of deviations from
>>the regulations. As a manufacturer of materials intended for animal feed
>>use, you are responsible for assuring that your overall operation and
>>the products you manufacture and distribute are in compliance with the
>>law. We have enclosed a copy of the FDA?s Small Entity Compliance Guide
>>to assist you with complying with the regulation.
>>
>>You should take prompt action to correct this violation, and you should
>>establish a system whereby such violation does not recur. Failure to
>>promptly correct this violation may result in regulatory action without
>>further notice, such as seizure and/or injunction.
>>
>>You should notify this office in writing within 15 working days of
>>receipt of this letter, of the steps you have taken to bring your firm
>>into compliance with the law. Your response should include an
>>explanation of each step being taken to correct the violation, and to
>>prevent its recurrence. If corrective action cannot be completed in 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 that corrections have been made.
>>
>>Please send your reply to the Food and Drug Administration, Attention:
>>Thomas S. Piekarski, Compliance Officer, 22201 23rd Drive SE, Bothell,
>>Washington 98021. If you have questions regarding any issue in this
>>letter, please contact Mr. Piekarski at (425) 483-4975. Sincerely,
>>Charles Breen District Director
>>
>>http://www.fda.gov/foi/warning_letters/g3276d.htm
>>
>>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...
>>
>>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
>>
>>Greetings,
>>
>>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
>>agency, rumors that the FDA may regulate certain contact lenses as
>>cosmetics rather than as devices and the agency's re-examination of its
>>policies in light of First Amendment challenges.
>>
>>Although McClellan did not comment directly on any of the specific
>>examples cited by Kennedy, the nominee said that he sees no intent on
>>FDA's part to retreat from its mission of protecting the public health...
>>
>>snip...
>>
>>http://www.thompson.com/fda
>>
>>maybe i was not too far off when i acting in haste on the previous
>>thread on BSE-L, see archived thread;
>>
>>Subject: USA/THOMPSON TURNS TO COMMUNISM TACTICS, FDA TURNS TO SECRECY
>>ON MAD COW FEED WARNING LETTERS Date: Mon, 9 Sep 2002 12:07:02 -0700
>>From: Terry S. Singeltary Sr. Reply-To: BSE-L
>>
>>so, i was nosing around the FDA warning letters and other files, came
>>across these and thought since 1/2 to 1 GRAM is lethal to a cow, i
>>thought these TONNAGE in some of these violations i ran across most
>>interesting. no telling how many dead road-kill CWD infected carcasses
>>were rendered into this, along with whatever type TSE in USA cattle, and
>>we can't forget about all the scrapie infected sheep that may have been
>>added to the soup. with a combination of CWD, SCRAPIE, TME and all the
>>different variants that may have come from them over the years, what in
>>the world would you call the TSEs in USA cattle, once they test to find,
>>and then find? could be a nasty one. or maybe none at all? doubtful
>>though (just my opinion, if i still allowed one here);
>>
>>PRODUCT BioFlavor F2425, BioFlavor F21002 and BioFlavor C20058. The
>>product, packaged in 50 lb. bags, is labeled in part, *** PALATABILITY
>>ENHANCER INTENDED FOR CAT FOOD USE AT LESS THAN 10% *** INGREDIENT
>>LISTING: *** Beef Broth *** . Recall # V-140-2 CODE Product Codes F2425
>>107B-RB-1 107B-RB-2 149C 201D 202C 205D 210A F21002 143B 143D 146D 144B
>>144D 139D 142D 150D 151D 152C 152D 201C 205C 206C 208A 211A C20058 143D
>>144C 146C 208B RECALLING FIRM/MANUFACTURER Recalling Firm: Bioproducts,
>>Inc., Fairlawn, OH, by telephone and letter on April 5, 2002.
>>Manufacturer: Bioproducts, Inc., Aurora, MO. Firm initiated recall is
>>ongoing. REASON Animal feed product with beef protein does not contain
>>required BSE statement on labels.
>>
>>VOLUME OF PRODUCT IN COMMERCE 354,150 lbs.
>>
>>DISTRIBUTION TX, KS, MO and MI. _______________________
>>
>>PRODUCT Steamed Bonemeal in 50-lb. bags, product code C# 13581, packaged
>>under two different labels: Premium Steamed Bonemeal Manufactured by
>>Buchheit Premium Feeds, Perryville, MO, and Steamed Bonemeal
>>Manufactured for Siemer's Enterprises Inc., Teutopolis, IL. Recall #
>>V-141-2. CODE Not coded. RECALLING FIRM/MANUFACTURER Buchheit, Inc.,
>>Perryville, MO, by telephone on May 14, 2002. FDA initiated recall is
>>ongoing. REASON Label lacks BSE warning statement.
>>
>>VOLUME OF PRODUCT IN COMMERCE
>>
>>Approx. 902/50-lb. bags.
>>
>>DISTRIBUTION MO and IL.
>>
>>END OF ENFORCEMENT REPORT FOR JUNE 5, 2002
>>
>>####
>>
>>PRODUCT
>>
>>The following custom mixed animal feeds are recalled --- a)
>>[non-ruminant]: Horse Feed, Hog Feed, and 14% Pig Feed. Recall #
>>V-157-2; b) [ruminant]: Dairy Feed, Steer Feed, New Goat Feed, Cattle
>>Feed, and Beef Feed. Recall # V-158-2. CODE The product is coded only
>>with the manufacturing date and invoice numbers. All feed products
>>manufactured and shipped since July 9, 2001 are affected by this recall.
>>RECALLING FIRM/MANUFACTURER Recalling Firm: Shepard Grain Company, Inc.,
>>Urbana, OH, by telephone on January 11, 2002. Manufacturer: Shepard
>>Grain Company, Inc., W. Liberty, OH. FDA initiated recall is complete.
>>REASON Ruminant and non-ruminant animal feeds contain BSE prohibited
>>material, and are either misbranded or adulterated.
>>
>>VOLUME OF PRODUCT IN COMMERCE
>>
>>41,129 LBS (20.5 tons).
>>
>>DISTRIBUTION OH.
>>
>>END OF ENFORCEMENT REPORT FOR AUGUST 28, 2002 ####
>>
>>PRODUCT:
>>
>>Buckeye 40% Poultry Concentrate. Recall #V-016-1. CODES: The bags are
>>uncoded. Firm is recalling product manufactured since December 1998;
>>however, they are only completing field corrections on product
>>manufactured within the last six months (November 2000). MANUFACTURER:
>>Yachere Feed, Inc. Rockwood, Pennsylvania. RECALLED BY: Manufacturer, by
>>visit on 3/19/01 and 3/20/01. Firm-initiated recall complete.
>>
>>DISTRIBUTION:
>>
>>Pennsylvania.
>>
>>QUANTITY:
>>
>>Nine containers, each weighing 100 pounds.
>>
>>REASON: The animal feed contains product derived from mammalian tissues
>>and must bear the statement Do not feed to cattle or other ruminants
>>on the label to prevent the establishment and amplification of BSE
>>through feed. This statement does not appear on the label. ________
>>
>>PRODUCT:
>>
>>Our Own Pig & Hog Grower hog feed, packaged in 50 pound bags, with
>>paperboard tags sewn onto the bags. Recall #V-017-1. CODES: The bags are
>>uncoded. MANUFACTURER: The Perry Coal and Feed Company, Perry, Ohio.
>>RECALLED BY: Manufacturer, by telephone on March 22, 2001.
>>Firm-initiated recall complete.
>>
>>DISTRIBUTION:
>>
>>Ohio.
>>
>>QUANTITY:
>>
>>Approximately 350 pounds of hog feed (7/50 pound bags).
>>
>>REASON: The animal feed contains protein derived from mammalian tissues
>>and must bear the statement Do not feed to cattle or other ruminants
>>on the label to prevent the establishment and amplification of BSE
>>through feed. This statement does not appear on the label. ________
>>
>>PRODUCT
>>
>>Loweís 40% Hog Concentrate - swine feed for mixing grower and finisher
>>rations, in 50-pound bulk bags. Recall #V-057-0. CODE All codes between
>>August 1, 1999 and November 23, 1999. MANUFACTURER Lowe's Feed & Grain,
>>Inc., Bowling Green, Kentucky. RECALLED BY Manufacturer, by letter dated
>>November 18, 1999, and by telephone. Firm-initiated recall complete.
>>
>>DISTRIBUTION
>>
>>Ohio.
>>
>>QUANTITY
>>
>>12.46 tons were distributed.
>>
>>REASON Product contained protein derived from mammalian tissue and
>>according to regulation must bear the statement Do not feed to cattle
>>or other ruminants on the label. This regulation is designed to prevent
>>the establishment and amplification of BSE through feed. This statement
>>does not appear on the label. ________
>>
>>RECALLS AND FIELD CORRECTIONS: VETMED -- CLASS II
>>
>>________________________________
>>
>>RECALL NUMBER, PRODUCT AND CODE: V-353-1 through V-370-1, Chicken feed
>>products: Recall # Tag # Product V-353-1 587 B. Challenger Scratch Feed
>>V-354-1 588 B. 18% Gamebird Conditioner V-355-1 2060 B. Kickin' Chicken
>>Premium Game Cock Feed V-356-1 2066 B. Kickin' Chicken Premium Gamebird
>>16% V-357-1 586 B. Scratch Grain V-358-1 2051 B. Pit Performer 17%
>>V-359-1 575 B. Classic Yard Feed V-360-1 576 Eliminator Maintainer
>>V-361-1 578 Eliminator Conditioner V-362-1 586 Producer Scratch Grain
>>V-363-1 4587 Producer 12% Gamebird Yard Feed V-364-1 2065 Cleveland
>>Trophy Cock Feed V-365-1 80181AAA Consolidated Hen Scratch V-366-1 2051
>>B&B Maintenance 12 V-367-1 2052 B&B Conditioner 14 V-368-1 2050 B&B
>>Scratch 10 V-369-1 4590 Kingsport Original Prater Mix V-370-1 2062 PC 10
>>(unlabeled bags) ALL CODES The B indicates that the Burkmann Feeds
>>brand name is listed on the tag labels. The suspect products are also
>>bagged and distributed under the following private labels:
>>
>>Producer Feeds, Louisville, Kentucky Kingsport Milling, Kingsport,
>>Tennessee Consolidated Nutrition, L.C., Omaha, Nebraska B&B Feeds,
>>Knoxville, Tennessee Eagle Roller Mill Co., Inc., Shelby, North Carolina
>>Central Farm Supply of Kentucky, Inc., Louisville, Kentucky
>>
>>REASON: The chicken feed products may contain proteins derived from
>>mammalian tissues. The products are not labeled with the required BSE
>>caution statement Do Not Feed to Cattle or Other Ruminants.
>>
>>MANUFACTURER/RECALLING FIRM: Burkmann Feeds, London, Kentucky
>>
>>RECALLED BY: On May 5, 2001, the firm mailed recall letters with
>>attached BSE sticker-labels to all customers outside the state of
>>Kentucky. The recall notices were hand- delivered to customers within
>>the state of Kentucky by Burkmann's Sales Representatives. Customers
>>were asked to complete and return a recall response form that was
>>included with each letter documenting the numbers of bags and varieties
>>of products for which the customers affixed the BSE sticker-labels. The
>>firm expanded their recall on May 10, 2001, and mailed recall letters
>>with BSE labels and response forms to the affected customers. FIRM
>>INITIATED RECALL:
>>
>>Ongoing DISTRIBUTION: KY, GA, NC, TN, VA
>>
>>QUANTITY:
>>
>>933 tons _______________________________
>>
>>RECALL NUMBER, PRODUCT AND CODE: V-377-1, Renner's brand 45% meat and
>>bone meal, packed in 100 pound bags. REASON: The product contained
>>protein material derived from bovine mammalian tissues; however, the
>>bags are not labeled with the required BSE cautionary statement.
>>MANUFACTURER/RECALLING FIRM: F. W. Renner & Sons, Inc., Canton, Ohio
>>RECALLED BY: The recalling firm contacted the consignees by telephone on
>>June 19, 2001. FIRM INITIATED RECALL: Complete
>>
>>DISTRIBUTION: OH
>>
>>QUANTITY: 2,500 lbs _______________________________
>>
>>RECALL NUMBER, PRODUCT AND CODE: V-378-1 to V-384-1, RenPro 58% (brand
>>name) swine and poultry feeds in bulk, as follows: V-378-1 - Poultry
>>Layer #215 - guaranteed analysis 15% crude protein, 3% crude fat, and
>>3.5% crude fiber. V-379-1 - Poultry Layer #216 - guaranteed analysis 16%
>>crude protein, 3% crude fat, and 3.5% crude fiber. V-380-1 - Poultry
>>Layer #217 - guaranteed analysis 17% crude protein, 3% crude fat, and
>>3.5% crude fiber. V-381-1 - Poultry Layer #218 - guaranteed analysis 18%
>>crude protein, 3% crude fat, and 3.5% crude fiber. V-382-1 - Poultry
>>Layer #219 - guaranteed analysis 19% crude protein, 3.5% crude fat, and
>>4% crude fiber. V-383-1 - Poultry Prelay #115 - guaranteed analysis 16%
>>crude protein, 3% crude fat, and 5% crude fiber. V-384-1 - Poultry
>>Developer #110 - guaranteed analysis 14% crude protein, 3% crude fat,
>>and 5.5% crude fiber. MANFACTURER: Esbenshade Mills, Mount Joy, PA
>>RECALLED BY: On 5/24/01, the manufacturer notified their customers of
>>the labeling requirement via letter. FIRM INITIATED RECALL: Complete
>>
>>DISTRIBUTION: PA
>>
>>QUANTITY: None. The product turn over is two weeks or less.
>>
>>END OF ENFORCEMENT REPORT FOR July 25, 2001.
>>
>>http://www.fda.gov/
>>
>>on second thought, i now see why they are cutting back on these warning
>>letters of the infamous 8/4/97 ruminant-to-ruminant feed ban in the USA,
>>that never was. same reason they are not testing cows in sufficient
>>numbers to find any TSEs.
>>
>>they simply don't want to know, and don't want the public to know
>>either, thus keep the gold card 'BSE FREE'.
>>
>>one more time, to all EU/SEAC members please re-evaluate the current GBR
>>of the USA, and change from GBR II to GBR III. the complete GBR
>>assessment should be changed to include _all_ TSEs...
>>
>>P.S. i wonder how deer/elk feed would be listed on FDA site? odd with
>>all the products i sent through the list on deer/elk feed with _animal
>>protein_, i have not seen any warning letters on deer/elk feed. course,
>>it could be filed with the infamous and very handy 'non-species coding
>>system' that is used on imports (i documented here many times).
>>
>>still disgusted in Bacliff, Texas USA Terry S. Singeltary Sr.
>>
>>Terry S. Singeltary Sr. wrote:
>>
>>>######## Bovine Spongiform Encephalopathy
>>>#########
>>>
>>>Greetings and Happy Holidays,
>>>
>>>hi Linda,
>>>
>>>many thanks for this reply, was just checking in to see
>>>if anything new had happened since our last correspondence.
>>>i thought i had missed something?
>>>
>>> > Unfortunately, the new database is much more complicated than
>>>
>>> > the old one, and it does not lend itself to presenting data in
>>>
>>> > a simple spreadsheet as we did in the past.
>>>
>>>how convenient;-) i had no problems with the old one...
>>>
>>> > Please be assured that CVM is working to solve this problem,
>>>
>>> > and we do plan to post this data in the future.
>>>
>>>thank you, if USDA/APHIS are lucky, i will hold my breath until
>>>that time;-)
>>>
>>>nothing personal Linda, take care,
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