CC: kouhou@asahi.com
EDITORIAL: BSE inspection policy
------------------------------------------------------------------------
Japan should not rush to lift the ban on U.S. beef.
An expert panel of the Food Safety Commission reviewing Japan's mad cow
controls has given a virtual green light to a proposal to exclude young
cattle aged 20 months or less from mandatory testing for bovine
spongiform encephalopathy (BSE). The panel's recommendation will
probably pave the way for an easing of tough anti-BSE standards now in
place that require tests on all cattle for the brain-wasting disease.
This testing regime was introduced soon after Japan's first mad cow case
was revealed in 2001.
BSE is caused by the accumulation of misshapen proteins called prions in
body tissue, especially the brain. Since prion accumulation occurs
gradually, it is difficult to detect BSE infection in young cattle using
current testing techniques. This is why the European Union only tests
cattle over 30 months old.
In Japan, 11 of the roughly 3.5 million animals tested to date were
infected with the disease. Two were aged 21 months and 23 months. But
the amount of abnormal prions in their bodies was very small, somewhere
between 1/500th and 1/1,000th of the quantity typically found in
infected adult animals. The fact that these amounts are close to the
minimum that can be detected through testing apparently led the panel to
reason that the risk of human infection would not rise if cattle below
20 months old were excluded from testing.
The government originally planned to adopt the EU's testing standards.
But it eventually decided to screen all cattle out of concern that
distributing beef from both tested and untested animals could cause
market and consumer confusion and anxiety.
In the three years since rigorous testing was introduced, there has been
no rise in the number of new BSE cases. Meanwhile, more anti-BSE
measures have been implemented. The time is probably ripe for a review
of the test-all policy, and the case for that is also supported by the
experience in EU, which does not test young cattle.
Obviously, a comprehensive approach is essential for securing beef
safety. First of all, brain, spinal cord and other body parts in danger
of containing large amounts of prions must be eliminated from the beef
made available to consumers. But in separating such parts, infected
tissue could come into contact with uninfected meat.
That is why all beef must be tested for BSE infection before being put
into the food chain. It is vital that all these steps be taken
assiduously to prevent any error.
The proposed testing review echoes growing calls within the government
to lift the ban on U.S. beef imports. Some policymakers clearly hope the
panel's recommendation will help break the impasse in bilateral talks
over the import ban.
There are, however, several problems that must be sorted out before
resuming beef imports from the United States.
It is possible to trace the place of origin and the age of every animal
raised in Japan. But that is not easy in the United States, where cattle
are typically managed in herds. So accurately identifying beef cattle
younger than 20 months to exclude them from testing would be a big
challenge in the United States.
Another problem concerns the elimination of risky body parts. While all
cattle are subject to this requirement in Japan, only those aged 30
months or older are handled this way in the United States. Although the
United States stresses it has dramatically increased the number of cows
tested, the fact is that U.S. testing failed to detect animals showing
possible BSE symptoms this spring.
A review of Japan's test-all approach would not sharply narrow the wide
gap that exists between the two countries. The step would not allay
Japanese consumer fears about the safety of American beef. Japan should
urge the United States to adopt beef safety standards similar to those
in this country. That should be our bottom-line demand in talks over
resuming imports of U.S. beef.
Acting rashly to reopen the Japanese market to American beef would
shatter any recovering consumer confidence in the safety of beef. It
could also put the credibility of the government's food safety policy in
question.
--The Asahi Shimbun, Sept. 8(IHT/Asahi: September 9,2004) (09/09)
http://www.asahi.com/english/opinion/TKY200409090104.html
> Japan should not rush to lift the ban on U.S. beef.
>
amen. with all the TSEs being rendered over the decades and fed
back to animals for human consumption in the USA, no telling what
we are dealing with. just how many strains of CWD are there?
Research Project: Characterization of Strains of Chronic Wasting Disease
in North American Cervids
http://ars.usda.gov/research/projects/projects.htm?ACCN_NO=405904&showpars=true&fy=2003
over 20 strains of scrapie.
no telling what phenotype of TSE in cattle in the USA.
all this rendered and fed back to animals for human consumption for
decades. why would Japan even want USA beef?
http://www.competitivemarkets.com/pdf/USDAagencyCapture.pdf
http://www.vegsource.com/talk/madcow/messages/92885.html
http://www.competitivemarkets.com/ocm1.html
THE MAD COW DOWNER THAT WALKED
Dave Louthan - Killed the Mad Cow
http://maddeer.org/video/embedded/louthan.html
Senator Michael Machado from California
''USDA does not know what's going on''.
''USDA is protecting the industry''.
''SHOULD the state of California step in''
Stanley Prusiner
''nobody has ever ask us to comment''
''they don't want us to comment''
''they never ask''
i tried to see Venemon, after Candian cow was discovered with BSE.
went to see lyle. after talking with him... absolute ignorance... then
thought i should see Venemon... it was clear his entire policy was to
get cattle boneless beef prods across the border... nothing else
mattered... his aids confirmed this... 5 times i tried to see Venemon,
never worked... eventually met with carl rove the political... he is the
one that arranged meetingwith Venemon... just trying to give you a sense
of the distance... healh public safety... was never contacted... yes i
believe that prions are bad to eat and you can die from them...END
Dr. Stan bashing Ann Veneman - 3 minutes
http://maddeer.org/video/embedded/08snip.ram
Recall Authority and Mad Cow Disease: Is the Current System Good for
Californians?
Tuesday, February 24, 2004
JOINT HEARING
AGRICULTURE AND WATER RESOURCES HEALTH AND HUMAN SERVICES AND SELECT
COMMITTEE ON GOVERNMENT OVERSIGHT - MACHADO, ORTIZ, and SPEIER, Chairs
Choose a RealPlayer video --->
Selected excerpts:
Opening Statement by Senator Michael Machado
http://maddeer.org/video/embedded/machado.html
HERE IS THE TEXAS MAD COW THAT WENT TO THE RENDER WITHOUT BEING TESTED
AND OTHER MULTIPLE FLAWS IN THE SYSTEM;
July 13, 2004
IG Audit Finds Multiple Flaws in Mad Cow Surveillance Plan
Rep. Waxman raises questions about the effectiveness and credibility of
USDA's response to mad cow disease, citing an audit by the USDA
Inspector General that finds systemic deficiencies in the Department's
surveillance plan and new evidence that USDA misled the public in the
wake of the detection of an infected cow in Washington State.
- Letter to USDA
http://www.house.gov/reform/min/pdfs_108_2/pdfs_inves/pdf_food_usda_mad_cow_july_13_ig_let.pdf
http://www.house.gov/reform/min/pdfs_108_2/pdfs_inves/pdf_food_usda_mad_cow_july_13_ig_let.pdf
IG Draft Audit
http://www.house.gov/reform/min/pdfs_108_2/pdfs_inves/pdf_food_usda_mad_cow_july_13_ig_rep.pdf
http://www.house.gov/reform/min/pdfs_108_2/pdfs_inves/pdf_food_usda_mad_cow_july_13_ig_rep.pdf
May 13, 2004
Failure To Test Staggering Cow May Reflect Wider Problems
Rep. Waxman raises concerns that the recent failure of USDA to test an
impaired cow for BSE may not be an isolated incident, citing the failure
of USDA to monitor whether cows condemned for central nervous system
symptoms are actually tested for mad cow disease.
- Letter to USDA
http://www.house.gov/reform/min/pdfs_108_2/pdfs_inves/pdf_food_usda_mad_cow_may_13_let.pdf
http://www.house.gov/reform/min/pdfs_108_2/pdfs_inves/pdf_food_usda_mad_cow_may_13_let.pdf
===============================================
THAT ONE TEXAS MAD COW IS ONLY TIP OF ICE BURG;
No mad cow results for nearly 500 cows
By Steve Mitchell
United Press International
Published 8/11/2004 11:23 AM
WASHINGTON, Aug. 11 (UPI) -- The U.S. Department of Agriculture failed
to test for mad cow disease or collect the correct portion of the brain
on nearly 500 suspect cows over the past two years -- including some in
categories considered most likely to be infected -- according to agency
records obtained by United Press International.
The testing problems mean it may never be known with certainty whether
these animals were infected with the deadly disease. Department
officials said these animals were not included in the agency's final
tally of mad cow tests, but the records, obtained by UPI under the
Freedom of Information Act, indicate at least some of them were counted...
snip...
--
Steve Mitchell is UPI's Medical Correspondent. E-mail sciencemail@upi.com
Copyright © 2001-2004 United Press International
http://www.upi.com/view.cfm?StoryID=20040810-042935-2066r
EFSA Scientific Report on the Assessment of the Geographical BSE-Risk
(GBR) of the United States of America (USA)
Adopted July 2004 (Question N° EFSA-Q-2003-083)
[20 August 2004]
http://www.efsa.eu.int/science/efsa_scientific_reports/gbr_assessments/catindex_en.html
From: Terry S. Singeltary Sr. [flounder@wt.net]
Sent: Tuesday, July 29, 2003 1:03 PM
To: fdadockets@oc.fda.gov
Cc: ggraber@cvm.fda.gov; Linda.Grassie@fda.gov; BSE-L
Subject: Docket No. 2003N-0312 Animal Feed Safety System [TSS SUBMISSION
TO DOCKET 2003N-0312]
Greetings FDA,
snip...
PLUS, if the USA continues to flagrantly ignore the _documented_ science
to date about the known TSEs in the USA (let alone the undocumented TSEs
in cattle), it is my opinion, every other Country that is dealing with
BSE/TSE should boycott the USA and demand that the SSC reclassify the
USA BSE GBR II risk assessment to BSE/TSE GBR III 'IMMEDIATELY'. for the
SSC to _flounder_ any longer on this issue, should also be regarded with
great suspicion as well. NOT to leave out the OIE and it's terribly
flawed system of disease surveillance. the OIE should make a move on CWD
in the USA, and make a risk assessment on this as a threat to human
health. the OIE should also change the mathematical formula for testing
of disease. this (in my opinion and others) is terribly flawed as well.
to think that a sample survey of 400 or so cattle in a population of 100
million, to think this will find anything, especially after seeing how
many TSE tests it took Italy and other Countries to find 1 case of BSE
(1 million rapid TSE test in less than 2 years, to find 102 BSE cases),
should be proof enough to make drastic changes of this system. the OIE
criteria for BSE Country classification and it's interpretation is very
problematic. a text that is suppose to give guidelines, but is not
understandable, cannot be considered satisfactory. the OIE told me 2
years ago that they were concerned with CWD, but said any changes might
take years. well, two years have come and gone, and no change in
relations with CWD as a human health risk. if we wait for politics and
science to finally make this connection, we very well may die before any
decisions
or changes are made. this is not acceptable. we must take the politics
and the industry out of any final decisions of the Scientific community.
this has been the problem from day one with this environmental man made
death sentence. some of you may think i am exaggerating, but you only
have to see it once, you only have to watch a loved one die from this
one time, and you will never forget, OR forgive...yes, i am still very
angry... but the transmission studies DO NOT lie, only the politicians
and the industry do... and they are still lying to this day...TSS
http://www.fda.gov/ohrms/dockets/dockets/03n0312/03N-0312_emc-000001.txt
Terry S. Singeltary Sr. P.O. BOX 42 Bacliff, TEXAS USA
######### http://mailhost-alt.rz.uni-karlsruhe.de/warc/bse-l.html ##########
a few mad cow feed ban warning letters.
they had ceased posting these for over a year until
just recently. don't know why they started posting them
again ;-)
Public Health Service
Food and Drug Administration
Dallas District
4040 North Central Expressway
Dallas, Texas 75204-3145
June 15, 2004
Ref: 2004-DAL-WL-18
WARNING LETTER
CERTIFIED MAIL
RETURNED RECEIPT REQUESTED
Mr. Patrick ORay, CEO & President
Specialty Brands, Inc.
P.O. Box 51467
Ontario, CA 91761-1057
Dear Mr. ORay:
An inspection of your food manufacturing facility located at 601 E. 3rd
Street, Lampasas, Texas, was conducted on February 26 and March 1, 2004
by Investigators from the Food and Drug Administration (FDA). The
inspection found significant deviations from the requirements set forth
in Title 21, Code of Federal Regulations, Section 589.2000 - Animal
Proteins Prohibited in Ruminant Feed (21 CFR 589.2000). This regulation
is intended to prevent the establishment and amplification of Bovine
Spongiform Encephalopathy (BSE).
Our inspection revealed that your firm sells its reduction stream waste
for use as animal feed and that it contracted with [redacted] to dispose
of this manufacturing process stream waste. [redacted] used this process
stream waste as animal feed for ruminants.
At the close of the inspection, a list of inspectional observations (FDA
483) was issued to your firm and discussed with Mr. Anthony E. Rocz,
Plant Manager. The following violation was observed during the inspection:
Products that contain protein derived from mammalian tissues and that
are intended for use in animal feed must be labeled with the cautionary
statement, Do not feed to cattle or other ruminants, as required by 21
CFR 589.2000(d)(1). For example, your firm manufactures Mexican
specialty food products such as tortillas, taquitos, and burritos that
contain beef. The production process stream waste includes ground corn,
product shells, and filling material, it is then placed in a
transportable bin for disposal by feeding to livestock. This
transportable waste bin did not bear the cautionary statement Do Not
Feed to Cattle or Other Ruminants.
Because your manufacturing stream waste did not bear this cautionary
statement, these products are misbranded within the meaning of section
403(a)(1) of the Federal Food, Drug, and Cosmetic Act.
You should know that this serious violation of the law may result in FDA
taking regulatory action without further notice to you. These actions
include, but are not limited to, seizure and/or injunction.
We are in receipt of a letter from Mr. Anthony E. ROCZ, Plant Manager,
dated March 2, 2004, in which he stated that your factory was under a
contract with [redacted] to remove and dispose of the production stream
waste generated at the factory since April 15, 2003. Our investigators
conveyed to Specialty Brands, Inc., on February 24, 2004, that the
disposal container was not properly labeled to indicate that the
material is not to be fed to cattle or other ruminants in accordance
with the BSE regulation. On February 26, 2004, our investigators
returned to your plant and conveyed to Mr. Rocz that earlier that
morning they observed cattle consuming the manufacturing stream waste
supplied by your firm to [redacted] The practice of supplying process
stream waste to [redacted] was indefinitely suspended on February 26,
2004. At that time, an alternative waste removal service was obtained to
dispose of the process stream waste in a sanitary landfill facility and
each load would be logged, a manifest detailing the pounds of process
waste disposed would be generated, and a certification of proper
disposal is to be provided for the record. This alternative stream waste
disposal process appears to be acceptable. Your letter also states that
your corporate Food Safety and Quality Assurance department is in the
process of drafting a corporate wide policy to ensure that all of your
factories are in compliance with the BSE regulation.
It is necessary for you to take prompt action on this matter now. Please
notify this office in writing within fifteen (15) working days from the
date you receive this letter of the specific actions you have taken to
prevent the recurrence of the violations, and when those actions were
taken or will be taken at your other corporate facilities having similar
disposal plans. Your reply should be sent to Edwin Ramos, Compliance
Officer, at the above stated address. If you have any questions
concerning this letter, you may contact Mr. Ramos at 214-253-5218.
Sincerely,
/s/
Michael A. Chappell
Dallas District Director
cc:
Specialty Brands, Inc.
Mr. Anthony E. Rocz, Plant Manager
601 E Third Street
Lampasas, TX 76550-2903
http://www.fda.gov/foi/warning_letters/g4898d.htm
Public Health Service
Food and Drug Administration
Dallas District
4040 North Central Expressway
Dallas, Texas 75204-3145
June 10, 2004
Ref: 2004-DAL-WL-17
WARNING LETTER
CERTIFIED MAIL
RETURNED RECEIPT REQUESTED
Mr. Jack Chapman, Owner
Chapman Ranch
11071 CR 1255
Lampasas, TX 76550
Dear Mr. Chapman:
An inspection of your ruminant feeding operation located at 11071 CR
1255, Lampasas, Texas, was conducted on February 26 and March 1, 2004 by
Investigators from the Food and Drug Administration (FDA). The
inspection found significant deviations from the requirements set forth
in Title 21, Code of Federal Regulations, Section 589.2000 - Animal
Proteins Prohibited in Ruminant Feed (21 CFR 589.2000). This regulation
is intended to prevent the establishment and amplification of Bovine
Spongiform Encephalopathy (BSE).
Our inspection revealed that you feed prohibited material, as defined by
21 CFR 589.2000(a), to ruminants. This prohibited material consists of
manufacturing process stream waste from [redacted] a manufacturer of
products such as fully cooked tacos, burritos, and taquitos that contain
beef. This manufacturing process stream waste contains meat products
that have been cooked and offered for human food but that have not been
further heat processed for feed. This failure to further heat process
the material causes the feed to be adulterated under section
402(a)(2)(C)(i) because it contains an unapproved food additive (i.e.,
the meat products that have not been further heat processed for feed).
At the close of the inspection, copies of the BSE Guidance documents 69,
70 and 76 were provided to you and further discussed. Also, you
previously received a copy of 21 CFR 589.2000, the BSE regulation, which
was again explained in more specific detail. You should know that this
serious violation of the law may result in FDA taking regulatory action
without further notice to you. These actions include, but are not
limited to, seizure and/or injunction.
It is necessary for you to take action on this matter now. Please send a
written response to this office within fifteen (15) working days from
the date you receive this letter. Your response should specifically
identify the actions you are taking to correct the violations and
provide specific timeframes for achieving compliance. Also, as part of
your written response, you should provide information regarding the
current feeding practices followed at your facility and information
pertaining to the planned marketing of your animals. Your reply should
be sent to Edwin Ramos, Compliance Officer, at the above stated address.
If you have any questions concerning this letter, you may contact Mr.
Ramos at 214-253-5218.
Sincerely,
/s/
Michael A. Chappell
Dallas District Director
horizonal rule
http://www.fda.gov/foi/warning_letters/g4899d.htm
Public Health Service
Food and Drug Administration
Atlanta District Office
60 8th Street, N.E.
Atlanta, Georgia 30309
June 10, 2004
VIA FEDERAL EXPRESS
WARNING LETTER
(04-ATL-13)
M. Dennis Burroughs
President
B & G Seed Company
591 Beck Road
Hull, Georgia 30646
Dear Mr. Burroughs:
An inspection of your feed mill was conducted by a Food and Drug
Administration (FDA) investigator on March 30, 2004. Our investigator
determined that you manufacture various products, including ruminant
feeds, which are animal feeds within the meaning of section 201(w) of
the Federal Food, Drug, and Cosmetic Act (the Act}. The inspection
revealed significant deviations from the requirements set forth in Title
21, Code of Federal Regulations (21 CFR), Part 589.2000
--Animal-Proteins Prohibited in Ruminant Feed. This regulation is
intended to prevent the establishment and amplification of Bovine
Spongiform Encephalopathy (BSE). The deviations cause the feed being
manufactured and distributed by your facility to be misbranded within
the meaning of sections 403(a)(1) of the Act.
The inspection revealed that not all of your feeds that contain protein
derived from mammalian tissues and that are intended for use in animal
feed (prohibited material) were labeled with the statement Do not feed
to cattle or other ruminants, as required by 21 CFR 589.2000(d)(1) and
(c)(1)(i). An example is your B & G Pig Grower. In addition, you have
routinely provided scrap or salvage dog food containing prohibited
material to be used as pig feed that was not labeled with the required
statement. In the case of bulk feed ingredients, the statement could
appear on the placard and invoice that accompany the shipment. The lack
of the required statement causes these feeds to be misbranded as defined
in section 403(a)(1) of the Act.
Our investigator also noted that you had failed to provide for adequate
measures to avoid commingling or cross-contamination of products that
contain or may contain prohibited material into feeds that may be used
for ruminants, as required under 21 CFR 589.2000(e)(1)(iii). You also
failed to establish written procedures for separating products which may
contain prohibited material from all other protein products from the
time of receipt until the time of shipment, as required under 21 CFR
589.2000(e)(1)(iv).
The above is not intended as an all-inclusive list of violations at your
firm. As a manufacturer of animal feeds, you are responsible for
ensuring that your overall operation and the products you manufacture
and distribute are in compliance with the law. We have included a copy
of the FDA Guidance for Industry 68 - Small Entities Compliance Guide -
Protein Blenders, Feed Manufacturers, and Distributors.
You should take prompt action to correct the above violations, and you
should establish procedures 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 fifteen (15) working
days of the 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. We do note that you initiated some corrective
actions during the inspection, including a feed recall and printing new
labels. If corrective action cannot be completed within 15 working days,
state the reason for the delay and date by which the corrections will be
completed. Include copies of any available documentation demonstrating
that corrections have been made. Your response should be directed to
Philip S. Campbell, Compliance Officer, at the address noted in the
letterhead.
Sincerely,
/s/
Mary Woleske, Director
Atlanta District
http://www.fda.gov/foi/warning_letters/g4900d.htm
-------- Original Message --------
Subject: MAD COW FEED BAN WARNING LETTERS JULY 20, 2004 USA
Date: Tue, 20 Jul 2004 09:14:11 -0500
From: "Terry S. Singeltary Sr."
Reply-To: Bovine Spongiform Encephalopathy
To: BSE-L@uni-karlsruhe.de
######## Bovine Spongiform Encephalopathy #########
USA BSE/TSE TRIPLE FIREWALLS SEEPING IN 2004...TSS
Public Health Service
Food and Drug Administration
San Francisco District
1431 Harbor Bay Parkway
Alameda, CA 94502-7070
Telephone: 510/337-6700
VIA HAND DELIVERY
Our Reference No. 1000123954
June 23, 2004
Ronald M. Foster, Manager
Randall C. Boyce, Manager
Trevor O. Foster, Manager
George P. Foster, Manager
Fresno Farming LLC
P.O. Box 457
1000 Davis Street
Livingston, California
WARNING LETTER
Dear Mssrs. Foster, Boyce, Foster, and Foster:
The U.S. Food and Drug Administration (FDA) conducted an inspection of
your medicated animal feed mill operation, Fresco Farming LLC, located
in Traver, California from April 14, 2004 through May 6, 2004, and found
significant deviations from the requirements set forth in Title 21, Code
of Federal Regulations, Section 589.2000 (21 C.F.R. 589.2000) - Animal
Proteins Prohibited in Ruminant Feed. The regulation is intended to
prevent the establishment and amplification of Bovine Spongiform
Encephalopathy (BSE). Because you failed to follow this rule, products
you manufactured and distributed are adulterated within the meaning of
Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act)
because they were prepared, packed, or held under insanitary conditions
whereby they may have been rendered injurious to health.
Our inspection found the following violations of 21 C.F.R. 589.2000:
1. Failure to provide for measures to avoid commingling or
cross-contamination of products that contain or may contain protein
derived from mammalian tissues into animal protein or feeds that may be
used for ruminants to comply with 21 C.F.R. 589.2000(e)(1)(iii).
* Your firm uses a vacuum system to clean up spilled product in the
tunnel area. This tunnel area houses the two receiving conveyor
systems and the elevators for the two conveyor systems. When
product, including ruminant meat and bone meal, is spilled onto
the floor of this area, the spilled product is vacuumed up by the
vacuum system and, via a discharge hose, was placed into a
conveyor system that your firm had designated as free of ruminant
meat and bone meal. Your firm admitted that it was unaware of the
vacuum system discharging into the conveyor systems designated as
free of ruminant meat and bone meal and that this had been in
place since April 2003. Your firm remedied this problem during
FDAs April/May 2004 inspection by removing the discharge hose
connection to the conveyer system that your firm had designated as
free of ruminant meat and bone meal .
* Your firm uses a dust collection system that pulls dust from
systems that receive both ruminant meat and bone meal and feed
ingredients intended for ruminants. This dust system then
discharged collected product back into the two conveyor systems
via a cross connection, thereby making it likely that ruminant
meat and bone meal became commingled with ruminant feed
ingredients. Your firm admitted that it was unaware of the cross
connection and that it had been in place since April 2003. Your
firm removed the cross connection during FDAs April/May 2004
inspection.
2. Failure to maintain written procedures specifying the clean-out
procedure or other means, and specifying the procedures for separating
products that contain or may contain protein derived from mammalian
tissue from all other protein products from the time of receipt until
the time of shipment, to comply with 21 C.F.R. 589.2000(e)(1)(iv). This
observation was also noted during FDAs July/August 2003 inspection of
your firm.
* There are no written procedures for separating products that
contain prohibited material from ingredients used in ruminant
feeds from the time of receipt until the time of shipment.
* The written procedure for cleaning out or flushing equipment after
mixing feeds containing prohibited material was not adequate to
prevent contamination of ruminant feed with prohibited material.
3. Failure to maintain records sufficient to track materials that
contain protein derived from mammalian tissues throughout their receipt,
processing, and distribution to comply with 21 C.F.R. 589.2000(e)(1)(i).
This observation was also noted during FDAs July/August 2003 inspection
of your firm.
* Specifically, your firm has failed to develop and implement
complete written procedures to separate ruminant meat and bone
meal from feed ingredients intended for ruminants from the time of
receipt until the time of distribution. The written procedures
that do exist fail to address the use of equipment common to
ruminant meat and bone meal and ruminant feed ingredients.
The above is not intended to be an all-inclusive list of deficiencies at
your facility. As a manufacturer of materials intended for use as animal
feed, you are responsible for assuring that your overall operation and
the products you manufacture and distribute are in compliance with the law.
You should take prompt action to correct 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 fifteen (15) working
days of receiving 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 actions cannot be completed in
fifteen (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 U.S. Food and Drug Administration,
Attention: Ms. Harumi Kishida, Compliance Officer, 1431 Harbor Bay
Parkway, Alameda, California 94502-7070. If you have questions regarding
this letter, please contact Ms. Kishida at (510) 337-6824.
Sincerely,
/s/
CD Moss, Acting DD for
Barbara J. Cassens
District Director
San Francisco District
cc:
VIA CERTIFIED MAIL
RETURN RECEIPT REQUESTED
C. Michael Blasco, Feed Mill Manager
Fresno Farming LLC
P.O. Box 430
Traver, California 93673
http://www.fda.gov/foi/warning_letters/g4849d.htm
Public Health Service
Food and Drug Administration
Chicago District
550 West Jackson Blvd., 15th Floor
Chicago, Illinois 60661
Telephone: 312-353-5863
July 12, 2004
WARNING LETTER
CHI-16-04
CERTIFIED MAIL
RETURN RECEIPT REQUESTED
Mr. Donald E. Hamilton, President/Owner
Illini Feeds, Inc.
P.O. Box 86, 1145 State Hwy. 94
Aledo, Illinois 61231
Dear Mr. Hamilton:
On February 19 and 20, 2004, the Food and Drug Administration (FDA)
conducted an inspection of your animal feed handling facility located at
1145 State Highway 94, Aledo, Illinois. The inspection found significant
deviations from the requirements set forth in Title 21, Code of Federal
Regulations, Part 589.2000 (21 CFR 589.2000) - Animal Proteins
Prohibited in Ruminant Feed. This regulation is intended to prevent the
establishment and amplification of Bovine Spongiform Encephalopathy
(BSE). The deviations cause the swine feed manufactured by your facility
to be misbranded within the meaning of Section 403(a)(1) of the Federal
Food, Drug, and Cosmetic Act (the Act).
Our investigation found that salvaged pet food containing prohibited
material was added as an ingredient to the swine products manufactured
at your facility. During the inspection, our investigator found that you
failed to label your non-ruminant products with the required caution
statement - Do not feed to cattle or other ruminants. [21 CFR
589.2000(d)(1)]
The above is not intended to be an all-inclusive list of violations. As
a manufacturer of materials intended for use in animal feed, you are
responsible for assuring that your overall operation and the products
you manufacture and distribute are in compliance with the law.
You should take prompt action to correct this violation, and you should
establish a system whereby such violations do not recur. Failure to
promptly correct this violation may result in regulatory action without
further notice, such as seizure and/or injunction.
During the inspection, you told the investigator that you would put the
required cautionary statement on your products that contain prohibited
material, and maintain tracking documents for all incoming ingredients,
including animal proteins prohibited in ruminant feed. Please notify
this office in writing within 15 working days of receiving this letter
of any further steps you have taken to assure that your firm is in
compliance with the law. Your response should also include an
explanation of each step taken to correct the violations, and prevent
their recurrence. Please include copies of any available documentation
such as written procedures, corrected labeling, etc., demonstrating that
corrections have been made. If corrections cannot be completed within 15
working days, state the reason for the delay and the date by which the
corrections will be completed.
Your reply should be directed to Paul A. Boehmer, Compliance Officer, at
the above address.
Sincerely,
/s/
Scott J. MacIntire
District Director
http://www.fda.gov/foi/warning_letters/g4840d.htm
Public Health Service
Food and Drug Administration
Chicago District
550 West Jackson Blvd., 15th Floor
Chicago, Illinois 60661
Telephone: 312-353-5863
June 15, 2004
WARNING LETTER
CERTIFIED MAIL
RETURN RECEIPT REQUESTED
Mr. David W. Bernauer
CEO and Chairman of the Board
Walgreen co.
200 Wilmot Rd.
Deerfield, IL 60015
Dear Mr. Bernauer:
Inspection of your firms warehouse at 5100 Lake Terrace N.E., Mt.
Vernon, Illinois, by the Illinois Department of Public Health and the
U.S. Food and Drug Administration (FDA) on February 25, 26, and 27, and
March 2, 2004, documented numerous insanitary conditions which caused
the food and drug products stored there to become adulterated.
Our inspection showed that the food and drug products stored and held at
your facility violated the Federal Food, Drug, and Cosmetic Act (the
Act), rendering them adulterated. These adulterated fwd and drug
products: a) consisted in whole or in part of filthy substances,
including rodent fecal pellets, rodent hair, and insects, in violation
of Section 402(a)(3) of the Act [21 U.S.C. 342(a)(3)]; and/or b) had
been held under insanitary conditions whereby they have become
contaminated with rodent filth, in violation of Sections 402(a)(4) and
501(a)(2)(a) of the Act [21 U.S.C. 342(a)(4), 351(a)(2)(a)].
Evidence of rodent activity documented throughout the old and new
warehouse included dead mice in traps, excreta pellets, and gnawed paper
material observed in, on, and near food and drugs stored in the
warehouse. Rodents gnaw holes were observed into several packaged food
products with rodent hairs at gnaw holes into products. Many more fecal
pellets were on food and drug packages and still more were found near
the stored foods, drugs, and cosmetics in the warehouse.
Other conditions observed during the inspection that could be
contributing factors to rodent infestation include damaged and/or poorly
fitting rail and truck dock doors, gaps around a conduit entry into the
building, and the structural condition of the concrete and expansion
gaps at floor/wall/support beam junctions in various areas of the
warehouse allowing the entry or harborage of pests. Additionally, the
investigators observed cobwebs, dead insects, dust, debris, product
spillage, and papers in the warehouse, indicating a general lack of good
sanitation practices.
Also, products that contain or may contain animal protein prohibited
ruminant feed (BSE material) failed to bear the caution statement, Do
not feed to cattle or other ruminants. Specifically, pet food products
were salvaged, repackaged, and donated to [redacted] and other similar
organizations in the area, without the proper labeling and agreement
that they would not be used for ruminants. Please refer to Title 21,
Code of Federal Regulations, Section 589.2000, concerning these
requirements.
Our laboratory confirmed the findings of rodent excreta, rodent hairs on
product gnaw holes, and rodent gnawed fibers (packaging material)
sampled from the warehouse during the inspection.
The above listed violations are not intended to be all-inclusive. It is
your responsibility to assure adherence with each requirement of the Act
and its implementing regulations. The investigators reported that you
destroyed food products that showed evidence of contamination and began
to take some steps to correct the insanitary conditions in your
facility. We request that you take prompt action to correct all violations.
Please provide this office, within 15 working days of receipt of this
letter, a detailed response stating the actions you plan to take and
have taken to correct and prevent the recurrence of these objectionable
conditions. Provide the time within which corrections will be completed,
reasons why any corrective action cannot be completed, and documentation
to show that corrections have been made. Failure to take prompt action
to correct all violations may result in regulatory action without
further notice. Such action includes seizure and/or injunction.
Your reply should be directed to Paul A. Boehmer, Compliance Officer, at
the Chicago District Office.
Sincerely,
/s/
Scott J. MacIntire
District Director
cc:
Stephen J. Lawrence,
Distribution Center Manager
Walgreen Co.
5100 Lake Terrace NE
Mount Vernon, IL 62864-9665
http://www.fda.gov/foi/warning_letters/g4853d.htm
USA BSE GBR SHOULD BE GBR III, but someone dropped the ball...
TSS
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##########RECALLS AND FIELD CORRECTIONS: VETERINARY - CLASS II
_______________________________
PRODUCT
a) Bulk whole corn. Recall # V-150-4;
b) Bulk rolled corn. Recall # V-151-4;
c) Bulk rolled corn with added fat. Recall # V-152-4.
CODE
No coding information is used.
RECALLING FIRM/MANUFACTURER
Fresno Farming LlC, Traver, CA, by letters on June 30, 2004. Firm
initiated recall is ongoing.
REASON
Corn for feed may be contaminated with RUMINANT MEAT AND BONE MEAL.
VOLUME OF PRODUCT IN COMMERCE
Unknown.
DISTRIBUTION
Unknown.
____________________________
http://www.fda.gov/bbs/topics/enforce/2004/ENF00857.html
Greetings list members,
> VOLUME OF PRODUCT IN COMMERCE
> UNKNOWN.
>
> DISTRIBUTION
> UNKNOWN.
gotta love those USDA BSE/TSE triple fire walls ;-).....TSS
######### http://mailhost-alt.rz.uni-karlsruhe.de/warc/bse-l.html
##########
kindest regards,
Terry S. Singeltary Sr.
P.O. Box 42
Bacliff, Texas USA 77518
