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From: TSS (216-119-143-243.ipset23.wt.net)
Subject: AMERICANS WILL EAT ANYTHING, INCLUDING FECES, HORMONES, ANTIBIOTICS, TSEs and other dangerous pathogens, why are we so dumb?
Date: August 17, 2004 at 2:57 pm PST


-------- Original Message --------
Subject: AMERICANS WILL EAT ANYTHING, INCLUDING FECES, HORMONES, ANTIBIOTICS, TSEs and other dangerous pathogens, why are we so dumb?
Date: Tue, 17 Aug 2004 16:57:02 -0500
From: "Terry S. Singeltary Sr."
To: Bovine Spongiform Encephalopathy


AMERICANS WILL EAT ANYTHING, INCLUDING FECES, HORMONES, ANTIBIOTICS,
TSEs and other dangerous pathogens, why are we so dumb?

Subject: Gallup Poll Tuesday Briefing - Mad Cow
> Fails to Spook Americans
>
> Good morning.
> I wanted to pass along the results of today's Gallup
> Poll Tuesday Briefing regarding Americans'
> confidence in the government's ability to protect
> our food supply.
> Bovine spongiform encephalopathy (BSE), better known
> as mad cow disease, appeared in the United States
> for the first time last December when a cow in
> Washington was diagnosed with the disease. The story
> was big news nationwide, as eating meat from
> BSE-infected cattle is believed to cause variant
> Creutzfeldt-Jakob disease, a fatal brain disorder in
> humans.
> Despite the relatively recent mad cow scare, Gallup
> Tuesday Briefing's July 2004 Consumption Habits poll
> shows that Americans are much more confident in the
> federal government's ability to protect the nation's
> food supply now than they were a few years ago.
> Nearly a third (31%) of Americans have "a great
> deal" of confidence in the federal government "to
> ensure the safety of the food supply in the U.S.,"
> up from 21% in July 2001 and 19% in July 2002. This
> percentage has more than doubled since 1999, when
> just 15% of Americans had a great deal of confidence
> in the government's ability to keep the food supply
> safe. The September 1999 survey was conducted just
> weeks after two record E. coli outbreaks in New York
> and Illinois.
> Despite the doubling in the percentage of Americans
> with a great deal of confidence in the government to
> protect the food supply, the fact remains that
> roughly 7 in 10 Americans express at best just "a
> fair amount" of confidence that the government can
> ensure the safety of the food supply. Fourteen
> percent of Americans have little or no confidence in
> the government in this regard.
> If you'd like to see the full results and
> methodology of the survey, I'd be happy to email
> them to you. Also, Gallup Poll Tuesday Briefing
> editor-in-chief Frank Newport is available for
> interviews.
> Thanks.
> Craig Sender (212-725-2295 x22)

OK, so the Americans are blinded on human/animal TSEs (blinded by
the Gov.), but the other pathogens that kill by far more documented
humans. BUT, why are other countries and there people much more
cautious on what they eat? WHY are they smarter? I mean countries
that import from the USA require very strict safety precautions to
protect human health. THESE precautions require plants to be
approved by EU veterinarians.

Germany for instance;

> Meat, poultry and seafood products (including game) from the United
> States can only be
> imported into Germany from plants approved by EU veterinarians. An
> EU-wide ban on
> growth-promoting hormones used for beef production has sharply reduced
> U.S. access to the
> EU beef market. Despite a favorable ruling by the World Trade
> Organization (WTO) the EU
> has yet to lift the ban. Due to EU import regulations, U.S. poultry
> meat is currently not
> permitted entry into the EU.


http://www.fas.usda.gov/gainfiles/200310/145986312.pdf

France;

Socio-economic and demographic changes have significantly altered food
trends in France.
Trends show that French consumers want food products that offer better
taste, higher
quality, convenience, and more health benefits:

snip...

· The BSE as well as other food scares have raised consumer concerns about
sanitation and safety issues. In turn, these concerns have led to
greater demand for
"natural" and "organic" food products--fruit juices, fresh and processed
dietetic
foods, organic produce, fish and seafood products, ethnic foods and food
supplements.

snip...

UNCLASSIFIED USDA Foreign Agricultural Service
6. Name of Best Prospect: MEAT AND OFFALS
Commodity Code Number: HS Code: 02 (in million dollars)
2000 2001 2002
(Jan-Dec)
A. Total Market Size 6,266 6,476 7,812
B. Local Production 6,550 6,590 7,938
C. Total Exports 2,876 2,534 2,586
D. Total Imports 2,592 2,420 2,460
GAIN Report - FR3061 Page 16 of 27
E. Total Imports from U.S. 19 24 16
F. Exchange Rate: USD 1.00 =Euros: 1.084 Euros: 1.116 Euros: 1.057
Source: French Customs/SCEES - French Ministry of Agriculture
Comments: Opportunities in this market are rather limited given the
import quota on meat
and stringent EU regulations in regard to hormone free beef. Most meat
imports from the
United States are horsemeat which were valued at $12 million in 2002,
while beef imports
amounted to $400,000. Bison meat is getting more and more popular in
France; most of
French imports originate from Canada, but there might be opportunities
there for U.S.
products.
SECTION V. KEY CONTACTS AND FURTHER INFORMATION
For further information contact:
Office of Agricultural Affairs
American Embassy
2, avenue Gabriel - 75382 Paris Cedex 08
Tel: (33-1) 43 12 2264
Fax: (33-1) 43 12 2662
Email: agparis@usda.gov
homepage: http://www.amb-usa.fr/fas/fas.htm

http://www.fas.usda.gov/gainfiles/200311/145986711.pdf

other countries;

pean Union - 2003 FAIRS REPORT


Austria FAIRS

Exporter Guide

Latvia Exporter Guide


Belgium FAIRS

Exporter Guide

Netherlands FAIRS

Exporter Guide


Czech Republic Exporter Guide

Poland FAIRS

Exporter Guide


Denmark FAIRS

Exporter Guide

Portugal FAIRS

Exporter Guide


Estonia Exporter Guide

Slovakia FAIRS

Slovak Food Industry and EU Accession


France FAIRS

Exporter Guide

Slovenia FAIRS

Exporter Guide


Germany FAIRS

Exporter Guide

Spain FAIRS

Exporter Guide


Greece FAIRS

Exporter Guide

Sweden FAIRS

Exporter Guide


Exporter Guide (Finland)


Hungary FAIRS

Exporter Guide

U.K. FAIRS

Exporter Guide


Italy FAIRS

Exporter Guide


August 2004
ADDITIONAL RESIDUE TESTING PROGRAM FOR FRESH MEAT
EXPORTED TO THE EU
The EU Additional Residue Testing Program is outlined in the European Union
Guidelines located in the Export Requirement library
(http://www.fsis.usda.gov.) This
program was initiated in 1989, under the responsibility of FSIS,
International Programs,
Export Coordination Division, with technical input from the Residue
Staff. All red meat
slaughter establishments approved for export of meat and/or offals to
the EU are required
to participate in the program. In 1996, the EU modified their residue
control requirements
for Member States, as well as for third countries. These requirements,
which are reflected
in Council Directive 96/22/EC and 96/23/EC, became effective July 1997.
The United
States has incorporated these modifications into the EU Additional
Residue Testing
Program.
Currently, the Office of Policy, Program Development and Evaluation (OPPDE),
International Policy Staff (IPS) coordinates the additional testing
program for products
destined to the EU. Technical assistance is provided from the Office of
Field Operations
(OFO), Technical Service Center (Import/Export Control Staff and the
Residue Control
Staff) (TSC), and the Office of Public Health and Science (OPHS). FSIS
continues to
progress the discussions with the European Commission ((DG SANCO) on
equivalence
of the residue control programs.
Effective March 1999, Agriculture Marketing Service (AMS), Science and
Technology
Program (S&T) initiated an oversight program of the laboratories
conducting analytical
residue chemistry for the EU program at the request of FSIS. AMS, S&T,
Technical
Services Branch, Washington, D.C. was responsible for the AMS European
Meat Export
Laboratory Program, which is now administered by FSIS, OPHS, Chemistry
Branch.
Currently, the only North American Laboratory qualified under this
program is Maxxam
Analytics, Inc., Missisauga, Ontario, Canada. Effective August 23, 2004,
the following is
the contact information: phone numbers (905) 817-5700 or 1-800-563-6266,
Email
info@maxxamanalytics.com and Website www.maxxamanalytics.com. Additional
laboratories interested in participating in this program should contact
FSIS, OPPDE, IPS
at (202) 720-6400 for additional information. A summary of the analyte
testing profile,
including the compounds, the method of detection, the target tissue,
species to be tested
and the target limit of detection, along with the EU action levels is
available.
Effective August 23, 2004, all tissue samples collected under this
program will be sent to
Maxxam Analytics, Inc., 6740 Campobello Rd., Mississauga, Ontario, L5N
2L8, Canada.
Page 2  Additional Residue Testing Program for Fresh Meat Exported to
the EU
The following steps outline the existing program:
Roles and responsibilities. OPHS, Biological Sciences Division,
Chemistry Branch:
Responsible for technical assistance, analytical and monitoring
components to assess and
oversee the analytical performance of the laboratories participating in
the EU Additional
Residue Program. AMS, S&T will serve on a consultative basis, as needed.
OPPDE, IPS: Responsible for negotiating the development of equivalence
of the residue
control programs with the European Union. Until an agreement is reached,
IPD will
continue to oversee the current program, working cooperatively with the
Technical
Service Center (TSC) to monitor the number of samples requested,
collected and
analyzed. IPS will receive and store results reported by the laboratory,
submit period
reports to the inspection personnel in the slaughter establishments and
submit an annual
summary of results to the EU. IPS is also responsible for approving any
modifications to
the testing categories and sample frequencies.
OFO, TSC, Import/Export Staff: Responsible for providing technical
support and
interpretation to the industry, as well as coordinating the addition or
removal of approved
slaughter establishments for the EU.
OFO, TSC, Residue Control Staff: Responsible for monitoring the monthly
sampling
regime, as well as the results of the residue analyses of the EU
program. Working
cooperatively with OPPDE and OPHS, the ROS will initiate FSIS follow-up
of violative
positive results by coordinating additional sampling, if warranted, and
appropriate
notification to the Food and Drug Administration and the producer.
OPHS, Food Hazard Surveillance Branch: Responsible for generating
monthly sample
request forms for distribution to participating slaughter
establishments, as well as
providing detail report of these scheduled samples to OFO/TSC and OPPDE/IPS.
OPHS/FSHD will work cooperatively with OPPDE/IPS to ensure timely
distribution of
the forms.
1. Participation in the program. All red meat establishments approved
for export to
the EU are required to participate in the additional residue program.
The TSC,
Import/Export Coordination Staff will coordinate the addition or removal
of an
approved slaughter plant. . Further, the slaughter establishment must advise
OFO/TSC if it operates on a seasonal basis, so that samples can be adjusted
accordingly. Any changes to this designation must be provided to the
TSC, who will
forward the information to OPPDE/IPS. Once a slaughter establishment becomes
eligible to ship to the EU, OPPDE/IPS communicates this to OPHS, Food Hazard
Surveillance Division (FSHD) in writing.
2. Sample requests. Sample request forms (FSIS form 10,210-3) are
preprinted and
distributed by OPHS, FHSD periodically. These forms are mailed directly
to the
Page 3  Additional Residue Testing Program for Fresh Meat Exported to
the EU
Inspector-In-Charge (IIC) at the designated establishment from
FSIS/Washington,
D.C. The information on the form includes the specified timeframe the
sample is to
be collected, the designated contract laboratory performing the
analyses, the target
tissue(s), and the compounds to be analyzed. Compounds are grouped
together into
testing categories, identifying the current compound/tissue matrix.
OPHS will
provide a monthly detail list or a summary of all the scheduled
samples to the TSC,
SOS, Residue Control Staff, when the sample request forms are mailed. In
addition, a
summary of the samples destined to each laboratory will be provided to
OPPDE/IPS.
The FSIS IIC will collect and secure the requested sample(s) and will
express mail
these to the appropriate laboratory overnight. If no sample is available
or the sample
request form arrives after the scheduled collection date, the form is
returned to the
OPPDE/IPS so that the sampling frequency can be adjusted, if necessary.
3. Number of samples (identification of compounds). The annual number of
samples
targeted per compound for 1999 is listed in the EU Requirements located
in the
Export Library. This sampling frequency is based on the volume of product
exported to the EU the previous year. Distribution of the samples
targeted for each
compound is based on the requirements as outlined in Council Directive
96/23/EC.
4. Reporting results. The independent laboratories must report results
of the
analytical tests to FSIS, OPPDE, IPS, who will forward these results to
the IIC in
the slaughter establishment. The laboratories may also provide copies of
the results
to the plant management at the approved slaughter plant. Annual
summaries of these
results are provided to the EC, which are transmitted by IPS.
Violative positive reports must be provided immediately to FSIS, so that
appropriate
action can be taken. OPPDE, IPS will notify OPHS and the TSC, as well as
the EC,
when a violation is reported, so that follow up action can be taken...

http://www.fsis.usda.gov/Frame/FrameRedirect.asp?main=/ofo/export/euresidu.pdf


HOWEVER, I find it extremely disturbing that most Americans are
satisfied with eating things that are so;

> diseased animals and/or medicated animals bearing potentially harmful
> drug residues to enter the food supply


Our investigation also found that you hold animals under conditions
which may allow diseased animals and/or medicated animals bearing
potentially harmful drug residues to enter the food supply. For example:

*

You do not maintain medication/treatment records identify the
animal, the date of treatment the drug used, dosage administered,
and the drug withdrawal times.

*

You do not have a system in effect for the review of treatment
records to assure that drugs have been used as directed in the
labeling and that the appropriate withdrawal times have been
observed.

*

Terramycin (Oxytetracycline HCl) observed in the drug storage are
on your farm, and used in the treatment of cattle, was past the
expiration date of April 2001.

An FDA 483, Inspectional Observations, was issued to you at the
conclusion of the inspection listing the objectionable conditions
observed during the inspection.

snip...

http://www.fda.gov/foi/warning_letters/g3786d.htm

MORE HERE;

http://www.accessdata.fda.gov/scripts/wlcfm/subject.cfm?FL=E

another dandy one;

Our investigation found that you hold animals under conditions that are
so inadequate that diseased animals and/or medicated animals bearing
potentially harmful drug residues are likely to enter the food supply.

http://www.fda.gov/foi/warning_letters/g3964d.htm

MORE HERE;

http://www.accessdata.fda.gov/scripts/wlcfm/subject.cfm?FL=D

FEI: 3004125694

04-BLT-11

February 3, 2004

WARNING LETTER

CERTIFIED MAIL
RETURN RECEIPT REQUESTED

Ralph L. Buckel, DVM, Co-owner and Gary R. Hash DVM, Co-Owner
Chestertown Animal Hospital
10530 Augustine Herman Highway
Chestertown, Maryland 21620

Dear Drs. Buckel and Hash,

The Food and Drug Administration (FDA) conducted an inspection at your
veterinary clinic located at Chester-town Animal Hospital, 10530
Augustine Herman Highway, Chester-town, Maryland, on August 20 and 27,
2003. The inspection was initiated in response to a United States
Department of Agriculture (USDA) report of an illegal gentamicin residue
in a bob veal calf offered for sale and slaughter for human food by
[redacted], a dairy producer located in Cordova, Maryland [redacted].
Chestertown Animal Hospital has performed veterinary work for this farm.

Our inspection found that Chester-town Animal Hospital prescribed,
compounded, and dispensed gentamicin and combinations of gentamicin with
other antibiotics for the treatment of bacterial infections in cows with
labeling specifying a 30-day meat withdrawal time. Since gentamicin
injection is not approved for use in cows, its extralabel use must
comply with FDAs regulations for extralabel drug use in animals, Title
21, Code of Federal Regulation (CFR), Part 530. Among the requirements
is that the veterinarian must establish a substantially extended
withdrawal period that is supported by appropriate scientific
information (21 CFR 530.20(a)(2)(ii)). However, the withdrawal period
you have established for the extralabel use of the gentamicin drug
products in cows is not supported by appropriate scientific information.
According to veterinary literature, no withdrawal period has been
scientifically established for gentamicin for use in cattle, and the
Food Animal Residue Avoidance Databank (FARAD) advises that a minimum
pre-slaughter withdrawal period of eighteen months or more be established.

We note that there have been two recent residue violations involving the
use of gentamicin at [redacted]. In one, on or about January 24, 2003,
the dairy farm sold a bob veal calf for slaughter s identified the
presence of 0.65 parts per million (ppm) of gentamicin in liver tissue
samples. This residue level is illegal since there is no established
tolerance for gentamicin in cattle. Our inspection revealed that you had
prescribed and dispensed the combination drug Gentamast
(penicillin/gentamicin) for the treatment of a dam and that this calf
received milk from the dam. In the other, [redacted] sold a cow for
slaughter on or about June 7, 2002, and USDA analysis identified the
presence of 0.61 ppm of gentamicin in kidney tissue. An investigation
revealed that Chestertown Animal Hospital dispensed Gentamast for the
treatment of that cow.

This letter may not list all the deviations at your facility. As
licensed veterinarians, you are responsible for ensuring that all drugs
you prescribe and administer comply with all requirements of the Food,
Drug, and Cosmetic Act (the Act) and its implementing regulations.

You should take prompt action to correct these violations and to
establish procedures to prevent their recurrence. Failure to do so may
result in regulatory action without further notice. These actions
include, but are not limited to, seizure and/or injunction.

Please notify this office in writing, within fifteen (15) working days
of receipt of this letter, of the specific steps you have taken to
correct these violations and prevent their recurrence. If corrective
action cannot be completed within 15 working days, state the reason for
the delay and the time frame within which corrections will be completed.
Your response should address each discrepancy brought to your attention
during the investigation and in this letter, and should include copies
of any documentation demonstrating that corrections have been made.
Please direct your reply to Ms. Vinetta Howard-King, Compliance Officer,
U.S. Food and Drug Administration, 6000 Metro Drive, Suite 101,
Baltimore, Maryland 21215.

Sincerely,

/S/

Lee Bowers,
District Director
Baltimore District

http://www.fda.gov/foi/warning_letters/g4525d.htm

VIA FEDERAL EXPRESS

June 29, 2004

Duaine E. Walker, Owner
Kenneth D. Walker, Owner
Walker Farms
3093 Anderson Avenue NE
Minerva, OH 44657

WARNING LETTER CIN-04-22024

Dear Mr. Walker:

An inspection of your dairy farm located in Minerva, Ohio by Food and
Drug Administration (FDA) Investigator Mishelle L. Harriger from
4/30/2004 - 5/6/2004 confirmed that you offered an animal for sale as
human food in violation of the Federal Food, Drug, and Cosmetic Act (the
Act). The animal (a bob veal calf) was adulterated food within the
meaning of sections 402(a)(2)(C)(ii) and 402(a)(4) of the ACT.

The United States Department of Agriculture (USDA)/Food Safety
Inspection Service (FSIS) analyses of tissues collected from the animal
disclosed the presence of the following drugs:

Animal ID Drug Tissue Level Tolerance
Back Tag 262 Neomycin Muscle detected None Established
Neomycin Kidney 88.24ppm None Established
Penicillin Kidney 0.06ppm None Established

Tolerance levels for residues of new animal drugs are found in Title 21,
Code of Federal Regulations (CFR), Part 556. There are no established
tolerances for either Neomycin or Penicillin in bob veal calves. As
such, the presence of these drugs in the edible tissues of this animal
causes the food to be adulterated within the meaning of section
402(a)(2)(C)(ii) of the Act.

The investigation also found that you hold animals under conditions that
could allow medicated animals, bearing potentially harmful drug
residues, to enter the food supply. For example:

* You do not maintain written records demonstrating that animals
that have received medications have been withheld from milk
production or withheld from slaughter for the number of days
indicated on the drugs label.
* You do not segregate animals that have been treated with
medications from the rest of the herd.
* You do not have a record of the medications that you purchase or use.

Food from animals held under such conditions is adulterated within the
meaning of section 402(a)(4) of the Act.

We also note that the [redacted] Auction has on file a certificate (or
guarantee ) from your firm stating that the animals that you sell there
do not contain any illegal drug residues. If you continue to medicate
animals without maintaining the records and procedures listed above, you
may be giving a false guarantee. Giving a false guarantee is prohibited
by section 301(h) of the Act.

You should take prompt action to correct the above violations and to
establish procedures whereby such violations do not recur. Failure to
correct the violations may result in regulatory action without further
notice. Such action includes seizure and/or injunction.

The violations listed above are not intended to be an all-inclusive
list. It is your responsibility to assure that your operations are in
compliance with the law.

You should be aware that it is not necessary for you to have personally
shipped an animal in interstate commerce to be responsible for a
violation of the Act. The fact that you caused the adulteration of an
animal that was subsequently offered for sale to a slaughterhouse that
ships in interstate commerce is sufficient to hold you responsible for a
violation of the Act.

You should notify this office in writing within 15 working days of the
steps you have taken to bring your firm into compliance with the law.
Your response should include each step being taken to correct the
violations and prevent their recurrence. If corrective action cannot be
completed within 15 working days, state the reason for the delay and the
time frame within which the corrections will be completed. Please
include copies of any available documentation demonstrating that
corrections have been made.

Your reply should be addressed to Food and Drug Administration, 6751
Steger Drive, Cincinnati, OH 45237-3097, Attention: Stephen J. Rabe,
Compliance Officer.

Sincerely,

/s/

Carol A. Heppe
District Director
Cincinnati District Office

http://www.fda.gov/foi/warning_letters/g4814d.htm

HERE is another page of these bad boys;

http://www.accessdata.fda.gov/scripts/wlcfm/subject.cfm?FL=I

ANOTHER dandy one;

On or about January 3, 2001, you sold a dairy cow identified with back
tag #7639 and listed as USDA Case #8-0375-00, Form #407287, for
slaughter as human food to [redacted]. USDA analysis of tissue samples
collected from that animal identified the presence of tilmicosin in the
liver at 25.70 parts per million (ppm). A tolerance of 1.20 ppm has been
established for residues of tilmicosin in the liver tissue of cattle
(Title 21 Code of Federal Regulations 556.735). USDA analysis also
identified 1.60 ppm in the muscle and 29.90 ppm in the kidney. There is
no established tolerance for tilmicosin in these edible tissues.

On or about June 12, 2001, you sold a dairy cow identified with back tag
#3431 and listed as USDA Case #8-0375-00, Form #407296, for slaughter as
human food to [redacted]. USDA analysis of tissue samples collected from
that animal identified the presence of penicillin in the liver at 00.29
ppm and in the kidney at 0.33 ppm. A tolerance of 0.05 ppm has been
established for residues of penicillin in edible tissues of cattle
(Title 21 Code of Federal Regulations 556.510).

On or about February 5, 2002, you sold a dairy cow identified with back
tag #5977 and listed as USDA Case #8-0375-00, Form #439522, for
slaughter as human food to [redacted]. USDA analysis of tissue samples
collected from that animal identified the presence of penicillin in the
liver at 00.47 ppm and in the kidney at 1.19 ppm. As stated above, a
tolerance of 0.05 ppm has been established for residues of penicillin in
edible tissues of cattle (Title 21 Code of Federal Regulations 556.510).

http://www.fda.gov/foi/warning_letters/g3279d.htm

another page full ;

http://www.accessdata.fda.gov/scripts/wlcfm/subject.cfm?FL=N

The inspection confirmed that you participated in a verbal agreement in
the capacity of the consulting/prescribing veterinarian for drugs
compounded by [redacted] from about November 1, 2001, through November,
2002. In the agreement, established by yourself and [redacted] Salesman
of [redacted] you provide veterinary services to farm and ranch clients
within a [redacted] mile radius of your firm by prescribing veterinary
drugs compounded by [redacted] During the time of this agreement,
dispensing records maintained by [redacted] identify you as the
authorizing/prescribing veterinarian for the following compounded drugs:

dipyrone fluphanazine*
gentamycin sulfate* fluoxetine*
Enrofloxacin* methylprednisolone
Ivermectin* ketoprofen
phenylbutazone flunixin

The drugs identified with the asterisks denote drugs that are prohibited
for extra label use in food producing animals under Title 21 CFR 530.41.

Records provided from your veterinary files document the following
example of your activities during your agreement with [redacted]

On 4/16/02, you authorized [redacted]s dispensing of the compounded
injectable prescription drugs, enrofloxacin (Baytril), ivomectin
(Ivermectin), and flunixine (Banamine) to [redacted] This
authorization was made without you establishing a valid VCPR with
the firm. Your veterinary files do not include documentation that
the drugs were identified particular species of animals to be
treated; diagnosis of a specific disease(s); dosage and time period
for treatment; or route of administration, cautionary statements, or
a withdrawal time(s) established for animals that may be marketed
for consumption as human food.

FDAs investigation found that [redacted] used the above prescription
veterinary drugs in the treatment of cattle. Ivermectin 2% sterile
injection present at [redacted] was labeled with a withdrawal time that
you, as the prescribing veterinarian, had taken no part in establishing.
Additionally, the enrofloxacin injection was labeled in part ** FOR USE
AS DIRECTED * Dr. THONI, ROB **. You confirmed, you have no records
establishing the need for these compounded drug products. In fact, FDA
approved versions of these drugs are available in the marketplace.

Our inspection documented dispensing by [redacted] and various RX orders
authorized by Dr. Rob Thoni, DVM as veterinarian of record during the
time of your agreement, of a compounded equine antibiotic, Gentamycin
100MG/ML-500ML injectable drug to [redacted] and other livestock
producers/growers in [redacted] You were unable to provide
patient/client records to support a VCPR with these operations.
Investigations found the drug was being used for medical treatment of
starter calves. These producers/growers include:

[redacted] on 9/10/02, RX [redacted]
[redacted] on 9/23/02, RX [redacted]
[redacted] on 10/15/02, RX [redacted]

I have attached a copy of the Form FDA-483, Inspectional Observations
issued by the investigators and discussed with you at the completion of
the inspection on February 5, 2003.

By prescribing, and authorizing the dispensing of the above listed drugs
by [redacted] you as the veterinarian accepting responsibility for the
medical treatment of animals, have caused the compounding of unapproved
new animal drugs, as well as, the shipment of those drugs in interstate
commerce. These drugs were compounded, with the use of bulk active
pharmaceutical ingredients (APIs), for administration in food producing
animals and horses. [redacted] holds no approval of applications for the
above listed drugs as required pursuant to Section 512(a)(1)(A) of the
FD & C Act. The drugs are deemed unsafe, and therefore, are adulterated
within the meaning of Section 501(a)(5) of the FD & C Act.

As a licensed prescribing veterinarian, you hold the responsibility to
know and understand federal and state laws that apply to you and your
veterinary practice. The only legal compounding of animal drugs is
provided for under the Animal Medicinal Drug use Clarification Act of
1994 and its implementing regulations at 21 Code of Federal Regulations
(CFR) Part 530 - Extralabel Drug Use in Animals. 21 CFR 530.13 provides,
for a veterinarian or pharmacist to compound animal drugs on the lawful
written order of a licensed veterinarian only if certain conditions are
met. The conditions include the requirement that the compounding be
within the context of a valid VCPR, and that the compounding is
conducted with the use of already approved drug products. Compounding,
using bulk active pharmaceutical ingredients is not permitted.

You should take prompt action to correct the violations encountered and
assure that your future orders for prescription veterinary drugs, and
the authorized dispensing of those drugs for/to animals of your
clientele, are in fact legal products and their administration follows
all required conditions for use under the FD & C Act and regulations.
Failure to correct the conditions of your veterinary practice and to
establish procedures whereby such conditions do not recur may result in
further investigations and possible Agency actions against regulated
products and or responsible individuals.

You should notify this office in writing within 15 working days of the
steps you have taken to bring your firm into compliance with the law.
Your response should include each step taken, or to be taken, to correct
the violations and prevent their recurrence. Please include copies of
any available documentation demonstrating corrections have been made.
You should address your response to the attention of James R. Lahar,
Compliance Officer at the above letterhead address.

Sincerely yours,

/s/

Michael A. Chappell
Dallas District Director

http://www.fda.gov/foi/warning_letters/g4798d.htm

November 25, 2003

Ref: 2004-DAL-WL- 08

WARNING LETTER
CERTIFIED MAIL
RETURN RECEIPT REQUESTED

Mr. Jack R. Munn, R.Ph., President
Medical Park Pharmacy
9786 Skillman St.
Dallas, Texas 75243

PRODUCTS:

Albendazole
Clenbuterol
Dexamethasone
Enrofloxacin
lvermectin
Phenylbutazone Powder
Levamisole Hcl
Sulfadiazine Sodium
Cisapride

Dear Mr. Munn:

An inspection of your veterinary drug compounding operation, located at
the above address, conducted by an investigator of the Food and Drug
Administration (FDA) from this office on July 28/August 6, 2003,
disclosed significant violations of the Federal Food, Drug, and Cosmetic
Act (the Act). The investigator was accompanied by Mr. Cy Weich, R.Ph.,
Chief Compliance Officer of the Texas State Board of Pharmacy (TSBP).

Our investigation has determined that Medical Park Pharmacy is exceeding
the regulations under which a compounding pharmacy may compound
veterinary drugs. Our findings include, but may not be limited to:

The use of bulk active pharmaceutical ingredients (APls) under
circumstances that create public health concerns. Your compounded drugs
are processed using bulk APls. When used in food animals, these drugs
present particular safety concerns because of the possibility that
unsafe drug residues could occur in edible tissues. Your compounded
drugs are essentially duplicates of FDA approved animal drug products
available on the market. Additionally, some compounded animal drugs,
such as cisapride, have been withdrawn from the market for human use for
safety reasons

* Distribution of compounded animal drugs labeled! FOR VETERINARY
CLINIC USE, and otherwise lacking directions for patient specific use.
The prescription drugs distributed to individuals, farms, ranches, feed
stores, veterinarians, and animal clinics by your firm often fail to
record critical information necessary to establish treatment for a
specific species, or identification of the animal(s) to receive
treatment. Prescription drug labeling frequently fails to indicate
directions for use, and instead indicates See Veterinary References for
Dosage for Species and Organism. Drugs compounded for food animals do
not bear a withdrawal time established by a State licensed veterinarian;
instead withdrawal times printed on your product labels are provided by
your firm, and are not backed by scientific data supporting the
withdrawal periods indicated.

The veterinary drugs compounded and distributed by your firm are new
animal drugs within the meaning of section 201(v) of the Act (21 U.S.C.
321(v)). These animal drugs are adulterated under section 501(a)(5) of
the Act (21 U.S.C. 351(a)(5)) because they are unsafe within the meaning
of section 512 of the Act (21 U.S.C. 360b). Section 512. in part, deems
a new animal drug to be unsafe unless an approved New Animal Drug
Application (NADA) is in effect for the specific product in question.
None of the animal drugs you compound and distribute are the subject of
an approval by FDA.

The only legal compounding of animal drugs is provided under the Animal
Medicinal Drug Use Clarification Act and its implementing regulations at
21 CFR Part 530, Extralabel Drug Use in Animals. 21 CFR 530.13 allows a
veterinarian or pharmacist to compound animal drugs on the lawful
written order of a licensed veterinarian only if certain conditions are
met. The conditions include the requirement that the compounding be
within the context of a valid veterinanian-client-patient relationship
(VCPR), and that the compounding be conducted only with the use of
approved drug product & However, your firm compounded animal drugs using
bulk APIs, which is not permitted under 21 CFR 530.13(a). Moreover, some
of your animal drugs were compounded using the bulk drug substance
cisapride, which was withdrawn from the market for safety reasons. In
addition, it appears that your products were being compounded outside
the context of a valid VCPR, as required by 21 CFR 530.10(a), and that
your products were not labeled with directions for use specified by a
veterinarian, including the animal or animals in which the drug is
intended to be used,
as required by 21 CFR 530.12(c).

The above is not intended to be an all-inclusive list of violations by
your firm. It is your responsibility to ensure that your firms
operations and products are in compliance with the law and applicable
regulations. Our inspectional findings were listed on a Form FDA 483,
Inspectional Observations, which was issued and discussed with you at
the end of the inspection.

You should take prompt action to correct the noted violations, and you
should establish procedures whereby such violations do not recur.
Failure to promptly correct these violations may result in regulatory
sanctions. These sanctions include, but are not limited to, seizure
and/or injunction.

Within fifteen (15) working days of receiving this letter, you should
notify this office in writing of the specific steps you have taken to
correct the violations, including an explanation of each step being
taken to prevent the recurrence of similar violations. If corrective
action cannot be completed within fifteen (15) working days, state the
reason for the delay and the time period within which the corrections
will be completed. You may address your reply to James R. Lahar,
Compliance Officer, at the above address.

Sincerely,

/s/

Michael A. Chappell

Dallas District Director

horizonal rule

http://www.fda.gov/foi/warning_letters/g4411d.htm

Certified Mail

Return Receipt requested

Warning Letter

2003-DT-20

August 20, 2003

Mr. Patrick M. Hunter, President
H&H Feed & Grain, Inc.
14096 Portege Road
Vicksburg, Michigan 48007

Dear Mr. Hunter:

An investigation of your feed mill located at 14096 Portage Road,
Vicksburg, Michigan, conducted by a Food and Drug Administretion (FDA)
investigatar on February 6 and 14, 2003, found significant deviations
from the mquirementa relating to animal drugs and medicated feeds,
inctudfng the Veterinary Feed Directive (VFD) regulations (Title 21,
Code of Federal Regulations, section 556.6). Such deviations caused an
animal drug to be adulterated under Section 501 (a)(5) of the Federal
Food, Drug, and
Cosmetic Act (the Act) and misbranded under Section 504(a)(5) of the
Act. The deviations also caused animal feed to be adulterated under
Section 501 (a)(6) of the Act and misbranded under Section 604(b) of the
Act.

Our investigation found your feed mill to be manufacturing complete
medicated swine feeds containing the Veterinary Feed Directive (VFD)
drug Tilmicosin in a manner that does not conform to the requirements of
the Act and the agencys regulations.
The deviations include:

(1) Your feed mill failed to use the Type E medicated feed containing
Tumicosin in accordance with labeled mixing directions, which resulted
in sub-potent feeds. This caused it to be unsafe under Section 512(a) of
ths Act and adulterated within the meaning of Section 501(a)(6) of the Act.

(2) Your feed mill failed to follow the products conditions of use by
not feeding continuously for a 21 day period. This caused the drug to be
unsafe under Section 512(a) of the Act and adulterated within the
meaning of Section 501(a)(5) of the Act.

(3) Your feed mill manufactured Type C medicated feed containing
Tilmicosin that failed to contain labeling conforming to the animal
drugs approval.

For example, it did not contain ingredient statements, cautionary
statements, or withdrawal information. This caused the medicated feed to
be unsafe under Section 512(a) of the Act and adulterated within the
meaning of Section 501 (a)(6) of the Act.

(4) The VFD medicated feed labeling did not contain the cautionary
statement: Caution: Federal law limits this dnrg to use under the
professional supervision of a of a licensed veterinarian. Animal feed
beating or containing this veterinary feed directive drug shall be fed
to animils only by or upon a lawful veteranary feed directive issued by
a licensed veterinarian in the course of the veterinarian's
professional practice. 21 CFR 558.6(f) requires all labeling and
advertising of VFD drugs and animal feeds containing VFD druga to
prominently and conspicuously diapiay this statement. Your failure to do
so caused the animal feed to be misbranded within the meaning of Section
504(b) of the Act.

(5) Your firm manufactured, in June, October, and November of 2002, for
its own use and for distribution, at least [redacted] batches of VFD
feeds containing Tiimicosin when no VFD was in effect. Also, in October
of 2002 and February of 2003, you manufactured complete feeds not
covered by a complete and valid VFD. For example, some VFD on file at
your firm lacked the statement required in 21 CFR 558.6 (a)(4)(xii),
Extra-label use (i.e., use of this VFD tied in a manner other than as
provided for in the VFD drug approval) is strictly prohibited. Failure
to follow the VFD requirements caused the me4icated feed to be unsafe
under Section 512(a) of the Act and adulterated within the meaning of
Section 501 (a)(6) of the Act.

(6) Your firm has been distributing feeds containing a VFD drug since
early 2002, but has not submitted a notification letter to FDAs Center
for Veterinary Medicine that you intend to distribute animal feed
ccnteining a VFD drug as required by 21 CFR 5586(d). This causes the
drug to be misbranded within the meaning of Section 504(a)(3)(C) of the Act.

The above is not intended as an ail-inclusive list of violations. As a
manufacturer of medicated and non-medicated feeds, you are responsible
for ensuring that you are in complianca with the law. You ahoutd take
prompt action to cormot these violations, and
you should establish procedures whereby such violations do not recur.
Failure to promptly correct these violations may result in regulatory
acion without further natice, such as seizure and/or injunction.

You should notify this office, in writing, within fifteen (15) working
clays of receiving this letter of ths steps you have taken to bring your
firm into compliance with the law. Your response should include an
explanation of each step bsing taken to correct the
violations and prevent their nxxrrence, If corrective action cannot be
completed within 15 working days, state the reason for the delay and the
date by which the corrections till bo completed. Include copies of any
available documentation demonstrating that
corrections have besn made.

Your response should be directed to Mr. David M. Kaszubski, Director
Compliance Branch, at the address above.

Sincerely yours,

/s/

Joann M. Givens

District Director

Detroit District Office

http://www.fda.gov/foi/warning_letters/g4251d.htm

LET alone all the mad cow feed ban warning letters still coming in 2004,
just a few from last week;

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

MORE LISTED HERE (NOT ALL);

Menu Foods, Inc.
5/19/04

New Jersey District Office Animal Proteins Prohibited in Ruminant Feed
[PDF]
[HTML]
No

Millstone Agri Distributors
5/22/03

Nashville District Office Animal Proteins Prohibited in Ruminant Feed
[PDF]
[HTML]
No

Specialty Brands, Inc.
6/15/04

Dallas District Office Animal Proteins Prohibited in Ruminant Feed [PDF]

[HTML]
No

Zephyr Feed Company
5/28/03

Florida District Office Animal Proteins Prohibited in Ruminant Feed
[PDF]
[HTML]
No

All American Feed & Tractor
4/01/02

Seattle District Office Animal Proteins Prohibited in Ruminant
Feed/Adulterated [PDF]
[HTML]
No

Chapman Ranch
6/10/04

Dallas District Office Animal Proteins Prohibited in Ruminant
Feed/Adulterated [PDF]
[HTML]
No

Fresno Farming LLC
6/23/04

San Francisco District Office Animal Proteins Prohibited in Ruminant
Feed/Adulterated [PDF]
[HTML]
No

Sunnymead Ranch, Inc.
11/07/02

Dallas District Office Animal Proteins Prohibited in Ruminant
Feed/Adulterated [PDF]
[HTML]
No

Van Dyke Grain Elevators Inc
4/17/02

Seattle District Office Animal Proteins Prohibited in Ruminant
Feed/Adulterated [PDF]
[HTML]
No

Halter Feed & Grain, Inc.
4/08/04

Cincinnati District Office Animal Proteins Prohibited in Ruminant
Feed/Adulterated/Misbranded [PDF]

[HTML]
No

Horn's Feed Mill, Inc.
9/26/03

Chicago District Office Animal Proteins Prohibited in Ruminant
Feed/Adulterated/Misbranded [PDF]

[HTML]
No

B & G Seed Company
6/10/04

Atlanta District Office Animal Proteins Prohibited in Ruminant
Feed/Misbranded [PDF]
[HTML]
No

Bakery Trading Company
7/29/02

Kansas City District Office Animal Proteins Prohibited in Ruminant
Feed/Misbranded [PDF]
[HTML]
No

Bardstown Mill, Inc.
4/08/04

Cincinnati District Office Animal Proteins Prohibited in Ruminant
Feed/Misbranded [PDF]
[HTML]
No

Barr Animal Foods
5/06/03

Minneapolis District Office Animal Proteins Prohibited in Ruminant
Feed/Misbranded [PDF]
[HTML]
No

Darling International, Inc.
5/07/02

Seattle District Office Animal Proteins Prohibited in Ruminant
Feed/Misbranded [PDF]
[HTML]
No

Illini Feeds, Inc.
7/12/04

Chicago District Office Animal Proteins Prohibited in Ruminant
Feed/Misbranded [PDF]
[HTML]
No

Lincoln Land Livestock Co., Inc.
8/25/03

Chicago District Office Animal Proteins Prohibited in Ruminant
Feed/Misbranded [PDF]
[HTML]
No

Premium Nutritional Products, Inc.
4/15/04

Kansas City District Office Animal Proteins Prohibited in Ruminant
Feed/Misbranded [PDF]
[HTML]
No


http://www.accessdata.fda.gov/scripts/wlcfm/subject.cfm?FL=

Empresas Avicolas Colsus, Inc.
9/29/00

San Juan District Office Medicated Feed Manufacturing Facility [PDF]

No

Hunt & Behrens, Inc.
9/17/99

San Francisco District Office Medicated Feed Manufacturing Facility
[PDF]
No

Templeton Feed and Grain
5/22/00

Los Angeles District Office Medicated Feed Manufacturing Facility [PDF]

No

Fourth & Pomeroy Associates, Inc.
1/16/01

Kansas City District Office Medicated Feed Mill Operations/Adulterated
[PDF]
No

Xtra Factors
1/16/01

Kansas City District Office Medicated Feed Mill Operations/Adulterated
[PDF]
No

Andersen Dairy
4/29/97

Seattle District Office Medicated Feeds [PDF]

No

Arbie Mineral Feed Company, Inc.
10/30/97

Kansas City District Office Medicated Feeds [PDF]

No

Archer Daniels Midland Company
8/27/97

Cincinnati District Office Medicated Feeds [PDF]

No

ConAgra Corporation
1/28/98

New Orleans District Office Medicated Feeds [PDF]

No

Consolidated Nutrition, L.C.
8/31/00

San Juan District Office Medicated Feeds [PDF]

No

Crumbaker Pork, LLC
11/01/00

Kansas City District Office Medicated Feeds [PDF]

No

Eastport Feeds, Inc.
4/21/97

New York District Office Medicated Feeds [PDF]

No

Evergreen Mills, Inc.
12/18/98

Dallas District Office Medicated Feeds [PDF]

No

Farmers Coop Elevator Company
5/15/98

Minneapolis District Office Medicated Feeds [PDF]

No

Feed Rite, Inc. dba Zip Feed Mills
7/24/97

Minneapolis District Office Medicated Feeds [PDF]

No

Feed Rite, Inc. dba Zip Feed Mills
7/22/97

Minneapolis District Office Medicated Feeds [PDF]

No

Georigia Turkey Farms, Inc.
10/07/98

Atlanta District Office Medicated Feeds [PDF]

No

Interstate Marine Terminal
4/23/97

Kansas City District Office Medicated Feeds [PDF]

No

J & K Cattle Company
11/19/96

Dallas District Office Medicated Feeds [PDF]

No

Johnson, Carol
8/07/97

Baltimore District Office Medicated Feeds [PDF]

No

Kay Dee Feed Co., Inc.
3/25/97

Kansas City District Office Medicated Feeds [PDF]

No

Kelly, Joe
5/13/97

Atlanta District Office Medicated Feeds [PDF]

No

Koch Industries, Inc.
4/16/99

New Orleans District Office Medicated Feeds [PDF]

No

Krienke Brothers, Inc.
5/11/98

Minneapolis District Office Medicated Feeds [PDF]

No

Krienke, Lee L.
5/11/98

Minneapolis District Office Medicated Feeds [PDF]

No

Lindsay Farms
11/12/96

Kansas City District Office Medicated Feeds [PDF]

No

Manno Pro Corporation
3/18/97

San Francisco District Office Medicated Feeds [PDF]

No

Marquardt, Victor
9/19/97

Minneapolis District Office Medicated Feeds [PDF]

No

McArthur Farms, Inc.
4/28/97

Florida District Office Medicated Feeds [PDF]

No

MFA, Inc.
2/18/97

Kansas City District Office Medicated Feeds [PDF]

No

Moyer & Son Inc.
7/12/99

Philadelphia District Office Medicated Feeds [PDF]

No

New Milk Inc.
1/29/98

San Francisco District Office Medicated Feeds [PDF]

No

Nulaid Foods, Inc.
5/19/98

San Francisco District Office Medicated Feeds [PDF]

No

O. H. Kruse Grain & Milling
1/30/98

Los Angeles District Office Medicated Feeds [PDF]

No

Pipestone Grain Company
9/11/97

Minneapolis District Office Medicated Feeds [PDF]

No

Pipestone Grain Company
9/11/98

Minneapolis District Office Medicated Feeds [PDF]

No

PM Ag Products, Inc.
6/03/98

Dallas District Office Medicated Feeds [PDF]

No

Roseland Elevator
11/05/96

Minneapolis District Office Medicated Feeds [PDF]

No

Schisler, Fred
5/14/97

Baltimore District Office Medicated Feeds [PDF]

No

Slegers, Inc.
4/04/97

Seattle District Office Medicated Feeds [PDF]

No

Syfrett Feed Company, Inc.
12/21/98

Florida District Office Medicated Feeds [PDF]

No

Truckenmiller, Gary
8/08/97

Philadelphia District Office Medicated Feeds [PDF]

No

United Feed Co-op, Inc.
3/12/99

Florida District Office Medicated Feeds [PDF]

No

WB Smith Feed Mill, Inc.
4/02/97

Kansas City District Office Medicated Feeds [PDF]

No

Western Consolidated Cooperative
5/15/98

Minneapolis District Office Medicated Feeds [PDF]

No

Western Feed Mills, Inc.
4/23/97

Kansas City District Office Medicated Feeds [PDF]

No

Westway Trading Corporation
1/05/98

Dallas District Office Medicated Feeds [PDF]

No

Westway Trading Corporation
2/02/98

San Francisco District Office Medicated Feeds [PDF]

No

Weyandt, Hughey P.
7/16/97

Philadelphia District Office Medicated Feeds [PDF]

No

Weyandt, Terry A.
6/11/97

Philadelphia District Office Medicated Feeds [PDF]

No

Wilderness Farms
8/01/97

Philadelphia District Office Medicated Feeds [PDF]

No

Koch Poultry Company, Inc.
11/29/00

New Orleans District Office Medicated Feeds/Adulterated [PDF]

No

ConAgra, Inc.
12/27/99

Kansas City District Office Medicated Feeds/CGMP [PDF]

No

Draper Valley Farms, Inc.
2/18/00

Seattle District Office Medicated Feeds/CGMP [PDF]

No

Foster Poultry Farms
5/26/00

San Francisco District Office Medicated Feeds/CGMP [PDF]

No

Gessell Feed Mill, Inc.
10/06/00

Minneapolis District Office Medicated Feeds/CGMP [PDF]

No

Hiawatha Milling Company
11/12/99

Kansas City District Office Medicated Feeds/CGMP [PDF]

No

Hillandale Farms of Florida, Inc.
6/21/00

Florida District Office Medicated Feeds/CGMP [PDF]

No

Nelson and Sons, Inc.
5/02/00

Denver District Office Medicated Feeds/CGMP [PDF]

No

Pan American Grain Mfg. Co., Inc.
10/16/00

San Juan District Office Medicated Feeds/CGMP [PDF]

No

Star Milling Company
11/10/99

Los Angeles District Office Medicated Feeds/CGMP [PDF]

No

United Feeds, Inc.
6/09/00

Chicago District Office Medicated Feeds/CGMP [PDF]

No

University of Minnesota
10/13/99

Minneapolis District Office Medicated Feeds/CGMP [PDF]

No

Wenck Feeds, Inc.
10/03/00

Kansas City District Office Medicated Feeds/CGMP [PDF]

No

Western Consolidated Cooperative
6/15/99

Minneapolis District Office Medicated Feeds/CGMP [PDF]

No


Prestage Farms, Inc.
3/08/01

New Orleans District Office Meicated Feeds [PDF]

No


http://www.accessdata.fda.gov/scripts/wlcfm/subject_archive.cfm?FL=M

Nebraska Firm Recalls Ground Beef Products For Possible E. coli O157:H7

(Aug 3, 2004)
Carneco Foods, LLC, is voluntarily recalling approximately 497,000
pounds of frozen ground beef and beef patties.

http://www.fsis.usda.gov/News_&_Events/Recall_030_2004_Release/index.asp


View Positive Results by Year: View Positive Results by Year:


Raw Ground Beef Products Analyzed for E. coli O157:H7, Calendar Year 2004
Sample Source Collection Date Where Collected Product Status Positives
this Year Samples Analyzed this Year Total Positives Total Samples Analyzed
Federal Jul 13 FL Held 8 >3,951 254 >64,876
Federal Jun 23 WA Held 7 >3,494 253 >64,419
Federal Jun 23 CA Held 6 3,494 252 64,419
Federal Jun 8 CT Held 5 >2,992 251 >63,917
Federal Jun 2 CO Held 4 2,992 250 63,917
Federal May 5 PA Held 3 >2,406 249 >63,331
Federal Apr 28 TX Held 2 2,279 248 63,204
Federal Apr 21 MO Held 1 2,111 247 63,036


Sample Sources may include these types of establishments:

* Federal
* Retail
* State
* Import


FSIS began this microbiological testing program to detect Escherichia
coli O157:H7 in raw ground beef on October 17, 1994.

http://www.fsis.usda.gov/Science/2004_EColi_Positive_Results/index.asp


1: Emerg Infect Dis. 1999 Sep-Oct;5(5):607-25.

Food-related illness and death in the United States.

Mead PS, Slutsker L, Dietz V, McCaig LF, Bresee JS, Shapiro C, Griffin
PM, Tauxe RV.

Division of Bacterial and Mycotic Diseases, Centers for Disease Control
and Prevention, Atlanta, Georgia 30333, USA. pfm0@cdc.gov

To better quantify the impact of foodborne diseases on health in the
United States, we compiled and analyzed information from multiple
surveillance systems and other sources. We estimate that foodborne
diseases cause approximately 76 million illnesses, 325,000
hospitalizations, and 5,000 deaths in the United States each year. Known
pathogens account for an estimated 14 million illnesses, 60, 000
hospitalizations, and 1,800 deaths. Three pathogens, Salmonella,
Listeria, and Toxoplasma, are responsible for 1,500 deaths each year,
more than 75% of those caused by known pathogens, while unknown agents
account for the remaining 62 million illnesses, 265,000
hospitalizations, and 3,200 deaths. Overall, foodborne diseases appear
to cause more illnesses but fewer deaths than previously estimated.

http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=10511517&dopt=Abstract


March 17, 2000 / 49(SS01);1-51


Surveillance for Foodborne Disease Outbreaks --United States, 1993-1997

http://www.cdc.gov/mmwr/preview/mmwrhtml/ss4901a1.htm

Please note: An erratum has been published for this article. To view the
erratum, please click here
.

Sonja J. Olsen, Ph.D.
Linda C. MacKinon, M.P.H.
Joy S. Goulding
Nancy H. Bean, Ph.D.
Laurence Slutsker, M.D.

Division of Bacterial and Mycotic Diseases
National Center for Infectious Diseases

Abstract

Problem/Condition: Since 1973, CDC has maintained a collaborative
surveillance program for collection and periodic reporting of data on
the occurrence and causes of foodborne disease outbreaks (FBDOs) in the
United States.

Reporting Period Covered: This summary reviews data from January 1993
through December 1997.

Description of System: The Foodborne-Disease Outbreak Surveillance
System reviews data concerning FBDOs, defined as the occurrence of two
or more cases of a similar illness resulting from the ingestion of a
common food. State and local public health departments have primary
responsibility for identifying and investigating FBDOs. State, local,
and territorial health departments use a standard form to report these
outbreaks to CDC.

Results: During 1993-1997, a total of 2,751 outbreaks of foodborne
disease were reported (489 in 1993, 653 in 1994, 628 in 1995, 477 in
1996, and 504 in 1997). These outbreaks caused a reported 86,058 persons
to become ill. Among outbreaks for which the etiology was determined,
bacterial pathogens caused the largest percentage of outbreaks (75%) and
the largest percentage of cases (86%). Salmonella serotype Enteritidis
accounted for the largest number of outbreaks, cases, and deaths; most
of these outbreaks were attributed to eating eggs. Chemical agents
caused 17% of outbreaks and 1% of cases; viruses, 6% of outbreaks and 8%
of cases; and parasites, 2% of outbreaks and 5% of cases.

Interpretation: The annual number of FBDOs reported to CDC did not
change substantially during this period or from previous years. During
this reporting period, S. Enteritidis continued to be a major cause of
illness and death. In addition, multistate outbreaks caused by
contaminated produce and outbreaks caused by Escherichia coli O157:H7
remained prominent.

Actions Taken: Current methods to detect FBDOs are improving, and
several changes to improve the ease and timeliness of reporting FBDO
data are occurring (e.g., a revised form to simplify FBDO reporting by
state health departments and electronic reporting methods). State and
local health departments continue to investigate and report FBDOs as
part of efforts to better understand and define the epidemiology of
foodborne disease in the United States. At the regional and national
levels, surveillance data provide an indication of the etiologic agents,
vehicles of transmission, and contributing factors associated with FBDOs
and help direct public health actions to reduce illness and death caused
by FBDOs.

INTRODUCTION

snip...end.....TSS


Food-Related Illness and Death in the United States

Paul S. Mead, Laurence Slutsker, Vance Dietz, Linda F. McCaig, Joseph S.
Bresee, Craig Shapiro, Patricia M. Griffin, and Robert V. Tauxe
Centers for Disease Control and Prevention, Atlanta, Georgia, USA

------------------------------------------------------------------------
To better quantify the impact of foodborne diseases on health in the
United States, we compiled and analyzed information from multiple
surveillance systems and other sources. We estimate that foodborne
diseases cause approximately 76 million illnesses, 325,000
hospitalizations, and 5,000 deaths in the United States each year. Known
pathogens account for an estimated 14 million illnesses, 60,000
hospitalizations, and 1,800 deaths. Three pathogens, Salmonella,
Listeria, and Toxoplasma, are responsible for 1,500 deaths each year,
more than 75% of those caused by known pathogens, while unknown agents
account for the remaining 62 million illnesses, 265,000
hospitalizations, and 3,200 deaths. Overall, foodborne diseases appear
to cause more illnesses but fewer deaths than previously estimated...

snip...

http://www.cdc.gov/ncidod/eid/vol5no5/mead.htm


Summary

E. coli 0157:H7 is a unique and harmful strain of bacteria which can
cause serious health problems in infected persons. It is found mainly in
the feces of some cattle, and it appears to be widespread in the
environment. It may be transmitted to humans when meat contaminated with
feces during slaughter is consumed without proper cooking. It is also
easily spread among children through unsanitary practices when a child
has 0157:H7-caused diarrhea.

http://edis.ifas.ufl.edu/BODY_SS197

From: TSS (216-119-162-35.ipset44.wt.net)
Subject: SCIENTIFIC COMMITTEE ON ANIMAL NUTRITION...RESISTANT TO
Date: February 5, 2003 at 1:49 pm PST

In Reply to: Re: PUBLIC MEETING TO ADDRESS CODEX COMMITTEE ON RESIDUES
OF VETERINA RY DRUGS IN FOODS (Docket #03-002N)
posted by
TSS on February 5, 2003 at 1:35 pm:

SCIENTIFIC COMMITTEE ON ANIMAL NUTRITION...RESISTANT TO
ANTIBIOTICS OF HUMAN CLINICAL AND VETERINARY IMPORTANCE

EUROPEAN COMMISSION
HEALTH & CONSUMER PROTECTION DIRECTORATE-GENERAL
Directorate C - Scientific Opinions
C2 - Management of scientific committees; scientific co-operation and
networks
OPINION OF THE
SCIENTIFIC COMMITTEE ON ANIMAL NUTRITION
ON THE CRITERIA FOR ASSESSING THE SAFETY OF MICRO-ORGANISMS1
RESISTANT TO ANTIBIOTICS OF HUMAN CLINICAL AND VETERINARY IMPORTANCE
(adopted on 3 July 2001, revised on 24 January 2003)

1 At present, resistance is not of concern in fungi and in this
document, the term "micro-
organisms" refers only to bacteria
2
Acknowledgement
SCAN adopted this opinion on the basis of the preparatory work done by
the SCAN
ad'hoc Working Group, which was chaired by
" Dr Andrew Chesson
and included the following members:
" Dr Anders Franklin (rapporteur)
" Ir Aîmé Aumaître
" Dr Ola Sköld
" Prof. Roland Leclercq
" Prof. Atte von Wright
" Prof. Jean-François Guillot
1. BACKGROUND
In 1993, the Council of the European Union requested the inclusion of
micro- organisms in Council Directive 70/524/EEC. Micro-organisms used
as additives in animal nutrition and authorised at national level by
Member States had then to obtain a Community authorisation in accordance
with the requirements of Council Directive 70/524/EEC.
In September 1996, the Scientific Committee on Animal Nutrition was
requested by the Commission to assess for safety a number of dossiers
submitted for micro-organisms seeking a Community approval as a feed
additive. This led to the adoption on 26 September 1997 of the SCAN
"Report on the use of certain micro-organisms as additives in
feedingstuffs"2. The annex to this report lists the outcome of the
evaluations and is regularly updated as the assessment of each dossier
submitted to the Committee is concluded. Each assessment includes a
consideration

2 Report of the Scientific Committee on Animal Nutrition on the use of
certain micro-organisms as
additives in feedingstuffs of 26 September 1997 updated on 22 March 2001
3 of any identified resistance to antibiotics of human clinical and
veterinary importance.

Because of serious concerns about the growing level of resistance to
antibiotics in regular use in human medicine, the Scientific Steering
Committee was asked by the European Commission to undertake a major
review of the medical and non-medical use of antibiotics. Included in
its Opinion of the 28th May 19993 was the recommendation that the use of
antibiotics as growth promoters in animal nutrition
should be phased out. This recommendation arose from the recognition
that the presence of acquired resistance amongst the bacteria of the
animal digestive tract, developed primarily as a result of exposure to
antibiotics used as growth promoters, represents a large pool of
resistance genes. Since ingestion of bacteria derived from
animals is common, there is a consequent potential for resistance genes
in these bacteria to be transferred to human bacteria, although the
magnitude of this risk has yet to be established. The European
Commission announced in the White Paper on Food Safety of 12 January
20004 its intention to pursue the prohibition or phasing-
out of antibiotics used as growth promoters in the EU depending on their
potential use in human and veterinary medicine as part of its broad
strategy to control and contain antibiotic resistance.
The removal from the market of a number of antibiotics used as growth
promoters and the stated intention to phase out those remaining in use,
has changed the emphasis of the safety assessment of micro-organisms
intended for use as feed additives. The earlier requirement that
microbial additives should be compatible with antibiotic growth
promoters is now both superfluous and undesirable. Viable
micro-organisms used as the active agent(s) in feed additives should not
add to the pool of transferable antibiotic resistance genes already
present in the gut bacterial population or otherwise increase the
likelihood of transfer of resistance.
This principle, if applied literally, would rule against most microbial
products since micro-organisms susceptible to all groups of clinically
important antibiotics are rarely encountered. However, the basis of
resistance varies greatly as does the likelihood of intra- and
inter-species resistance transfer. Any conclusion on the
safety of microbial feed additives should be based on a current
understanding of the mechanism of resistance and resistance transfer and
should be proportionate to the risk identified while remaining
consistent with Commission policy.

full text pdf below highlighted in blue, just click on,
it may take a while to load...tss

http://europa.eu.int/comm/food/fs/sc/scan/out108_en.pdf

NOW, the industry is so wise to the fact the average American consumer
will eat everything including feces and think
it is good, that they succeeded in setting up TOTALLY SEPERATE
slaughter/renderig facilities for EXPORT ONLY
TO THE EU COUNTRIES, that removes everything from hormones to
antibiotics to SRMs for risk of BSE/TSE.
PEOPLE in the EU seem to be cautious as to what they eat and consume
compared to Americans, why is this?
WHY is it that the INDUSTRY that serves the AMERICAN consumer will set
up seperate facilities to remove
these dangerous substances ONLY for the EU market and not for the
AMERICAN consumer$

Export Library

EUREQ9 06/1/01

EXPORT REQUIREMENTS FOR THE EUROPEAN UNION

snip...

M. Stunning

The injection of air during stunning is prohibited.*

N. Opening of stomachs and intestines

There must be a separate room for emptying and cleaning stomachs and
intestines, unless the processing is done by closed-circuit mechanical
equipment which avoids contamination and eliminates odors.

O. Batch condemnation

If carcasses, offals and blood are not correlated at the final
postmortem inspection point, a batch system shall be operated in such a
way that the Inspector in Charge (IIC) can demonstrate that if a carcass
is condemned its offal and blood shall also be condemned.

P. Casings

Casing destined to the EU must be processed in EU approved
establishments that are operating under FSIS' inspection program, as
well as comply with the following additional EU requirements:

1. Medical certification for product handlers as outlined in Section III
of these requirements.

2. Water testing requirements as outlined in Section IV of these
requirements.

3. Hand wash basins in processing rooms and lavatories must not be
hand-operated.

4. Walls must be light colored, with washable coating, up to a height of
2 meters.

5. The use of wood is not allowed. However, wooden pallets may be
brought into processing rooms solely for the transport of packaged
casings.*

snip...

XVII. DOCUMENTATION - LIST OF REQUIRED CERTIFICATES

A. These requirements describe the conditions for export to the EU as
indicated in Council Decision 98/258 (the "Veterinary Equivalence
Agreement). Issuance of the indicated certificates meats that the
product complies with Decision 98/258. Only meat and poultry and meat
and poultry products slaughtered, processed, and stored at approved
establishments that meet the requirements described herein may be
certified for export to the EU. All certificates for EU except FSIS Form
9060-5 must have a preprinted blue seal. All EU documents must be signed
by an FSIS Veterinarian in a color other than black.*

B. The following SRM statement must be typed in the remarks section or
on a separate letterhead certificate for all meat from ruminants and
products containing meat from ruminants:

"The product of animal origin does not contain, and is not derived from,
specified risk material as defined in Annex I, point 1(a) of Decision
2000/418/EC, produced after 31 March 2001, or mechanically recovered
meat obtained from the bones of the head or vertebral column of bovine,
ovine or caprine animals, produced after 31 March 2001. The animals have
not been slaughtered, after 31 March 2001, after stunning by means of a
gas injected into the cranial cavity or killed instantaneously by the
same method, or slaughtered after laceration, after stunning, of central
nervous tissue by means of an elongated rod-shaped instrument introduced
into the cranial cavity."

Note: EU Decision 2000/418 Annex I, Point 1a refers to any of the
following "specific risk materials":

(1) the skull including the brains and eyes, the tonsils, the spinal
cord and the ileum of bovine animals aged over 12 months;* (2) the skull
including the brains and eyes, the tonsils and the spinal cord of ovine
and caprine animals aged over 12 months or that have a permanent incisor
erupted through the gum, and the spleen of ovine and caprine animals of
all ages.* snip...

XVIV. LISTS OF ELIGIBLE PLANTS

Lists of eligible plants for the various product categories are
available through the Export Library. Plants must meet all EU
requirements in addition to being listed on the appropriate list.
Contact the FSIS Technical Service Center, Export Staff for assistance
at (402) 221-7400.

http://www.fsis.usda.gov/OFO/export/euroreqs.htm

http://www.fsis.usda.gov/OFO/export/explib.htm#notices

LIST OF PLANTS APPROVED TO HANDLE IMMEDIATE SLAUGHTER ANIMALS
(including the last inspection dates)
This is the most current list. June 30, 2004

http://www.aphis.usda.gov/vs/ncie/pdf/slaughter_list.pdf

SADLY, this has been going on for years and the American consumer just
does not seem to
give a damn and i cannot figure this out. WE believe anything the
Government tells us, and
just who is the US Government, just look at the ones funneling the
money, THE INDUSTRY $$$

TSS





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