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From: TSS (216-119-134-120.ipset14.wt.net)
Subject: HOW ABOUT SOME ANTIBIOTICS WITH YOUR MEAT
Date: September 21, 2004 at 7:08 am PST

Department of Health and Human Services

Public Health Service
Food and Drug Administration

San Francisco District
1431 Harbor Bay Parkway
Alameda, CA 94502-7070
Telephone: 510-337-6700

Via Federal Express

Our Reference: 1000221388

August 10, 2004

John M. Troost and Jeff J. Troost, Partners
J Troost Dairy
24868 Road 9
Chowchilla, CA 93610

WARNING LETTER

Dear Messrs. Troost:

Tissue residue reports received by the Food and Drug Administration (FDA) from the United States Department of Agriculture (USDA) reported the presence of illegal drug residue in two cows that originated from your dairy located at 24686 Road 9, Chowchilla, CA. As a follow-up to USDA's findings, our investigators performed an inspection of your dairy operation April 8 through 19, 2004. This inspection confirmed that you offered two animals for sale for slaughter as food in violation of Sections 402(a)(2)(C)(ii) and 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act).

On February 27, 2004, you consigned three dairy cows, one of which was subsequently identified with [redacted] back tag number [redacted] (last three digits) and USDA retain tag #8013 (last four digits), for slaughter as human food. USDA analysis of tissue samples (USDA laboratory report number 394844) collected from that animal identified the presence of the drug penicillin in the kidney at 0.48 parts per million (ppm).

On October 27, 2003, you consigned four dairy cows, one of which was subsequently identified with [redacted] back tag number [redacted] (last three digits) and USDA retain tag #3769 (last four digits), for slaughter as human food. USDA analysis of tissue samples (USDA laboratory report number 366573) collected from that animal identified the presence of the drug penicillin in the kidney at 0.38 ppm and in the liver at 0.21 ppm.

The tolerance level for penicillin in kidney and/or liver of cattle is 0.05 ppm (Title 21 Code of Federal Regulations (CFR), Part 556.510.) Your use of penicillin in this animal resulted in the illegal drug residues found in the kidney and liver.

A food is adulterated under Section 402(a)(2)(C)(ii) of the Act if it contains a new animal drug that is unsafe within the meaning of Section 512.

A food is also adulterated under Section 402(a)(4) of the Act "if it has been prepared, packed, or held under insanitary conditions...whereby it may have been rendered injurious to health." As it applies in this case, "insanitary conditions" means that you hold animals which are ultimately offered for sale for slaughter as food under conditions which are so inadequate that medicated animals bearing possibly harmful drug residues are likely to enter the food supply. For example, our investigators noted the following:

1.

You lack an adequate system for assuring that drugs are used in a manner consistent with the directions contained in their labeling or your veterinarian's prescription labeling. For example, your veterinary label for [redacted] prescribes a withdrawal time of 18 days, however, for cow with ear tag #[redacted] you only observed an eleven (11) day withdrawal time. Your veterinarian’s prescription label for [redacted] requires a withdrawal time of 14 days, however for cow with ear tag #[redacted] you only observed a ten (10) day withdrawal period.
2.

You lack an adequate inventory/accountability system for determining the quantities of drugs used to medicate your cows.
3.

You fail to systematically review treatment records prior to offering an animal for slaughter for human food, to assure that drugs have been used only as directed and
that appropriate withdrawal times have been observed.
4.

You fail to maintain complete permanent medication treatment records on the dairy cows. For example, your treatment records fail to include the dosage administered, the route of administration, withholding times, and the person administering the drug.

You are adulterating the following drugs within the meaning of Section 501(a)(5) of the Act, in that they are new animal drugs within Section 201(v) of the Act, and are unsafe within the meaning of Section 512(a)(1)(B) of the Act since they are not being used in conformance with their approved labeling or valid veterinary prescription.

1.

[Redacted] injectable suspension: Your veterinarian prescribed a dosage of 4cc per 100 lbs, BID per cow with a withdrawal time of 18 days. The drug's labeling prescribes no more than 10 ml administered at one site for a maximum of four (4) consecutive days. You are administering the drug for seven (7) consecutive days with up to 25cc administered at one site and observing an eleven (11) day withdrawal time.
2.

[Redacted]: The veterinary label prescribes a meat withdrawal of 14 days. You have sent animals for slaughter as human food after only 10 days.
3.

[Redacted]: The labeling states that the drug is intended for oral administration to beef and non-lactating dairy cattle. You administer [redacted] to your mature lactating dairy cows and you failed to obtain a veterinary prescription for this use.
4.

[Redacted]: The manufacturer’s label prescribes a treatment of up to five (5) consecutive days. You are administering this drug up to six (6) consecutive days.
5.

[Redacted]: The veterinary label for [redacted] prescribes a dosage of 2 cc administered intramuscularly, to be repeated after seven (7) days with a meat withdrawal time of seven (7) days. You are administering 3 cc intramuscularly for up to two (2) consecutive days and are not following any withdrawal time for ECP.
6.

[Redacted]: You are using a solution of [redacted] treat foot wart in you cows, however, the manufacturer's labeling prescribes the drug for oral use in swine and broiler chickens only.

Failure to comply with the label instructions and/or veterinarian’s prescription on drugs you use to treat your animals presents the likely possibility that illegal residues will occur and makes the drugs unsafe for use. We request that you take prompt action to ensure that animals which you offer for sale as human food will not be adulterated with drugs or contain illegal residues.

Introducing adulterated foods into interstate commerce is a violation of Section 301(a) of the Act. Causing the adulteration of drugs after receipt in interstate commerce is a violation of Section 301(k) of the Act.

You should be aware that it is not necessary for you to have personally shipped an adulterated animal in interstate commerce to be responsible for a violation of the Act. The fact that you offered an adulterated animal for sale to a slaughter facility where it was held for sale in interstate commerce is sufficient to make you responsible for violations of the Act.

This is not intended to be an all-inclusive list of violations. It is your responsibility to ensure that all requirements of the Act are being met.

You should take prompt action to correct the violations observed during FDA’s inspection. Failure to achieve prompt corrections may result in enforcement action without further notice, including seizure and/or injunction.

We are extremely concerned about your firm's history of illegal drug residue in cows your dairy offers for sale or consignment for slaughter as human food. The USDA has reported eight (8) illegal tissue residues originating from your dairy since February, 2001. Some of the same significant insanitary conditions found during the most recent inspection were previously cited in a May 9, 1996 Warning Letter. In addition, that Warning Letter also cited the adulteration of drugs for failure to use the drugs in conformance with approved labeling. You should take prompt action to correct the violations observed during FDA's most recent inspection. Failure to promptly correct these violations may result in regulatory action without further notice, such as seizure and/or injunction.

You should notify our office in writing, within fifteen (15) working days of the receipt of this letter, of the specific steps you have taken to correct these violations and preclude their recurrence. If corrective action cannot be completed within fifteen 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 inspection and in this letter, and should include copies of any documentation demonstrating that corrections have been made. Please direct your reply to Russell A. Campbell, Compliance Officer, United States Food and Drug Administration, 1431 Harbor Bay Parkway, Alameda, CA 94502.

Sincerely yours,

/S/

Barbara J. Cassens
District Director
San Francisco District
http://www.fda.gov/foi/warning_letters/g4961d.htm

======================================

July 13, 2004

WARNING LETTER
CHI-17-04

CERTIFIED MAIL
RETURN RECEIPT REOUESTED

Mr. Roy Luth, Owner
Roy and Gladice Luth Farm
25024 Rt. 173
Harvard, IL 60033

Dear Mr. Luth:

An investigation of your dairy farm operation conducted from March 23 and 24, 2004, found that a dairy cow from your establishment, was offered for sale for slaughter as human food in violation of Section 402(a)(2)(C)(ii) of the Federal Food, Drug, and Cosmetic Act (Act).

On December 17, 2003, a dairy cow was sold for slaughter as human food to [redacted]. The United States Department of Agriculture analysis of tissue samples collected from that animal identified the presence of 0.50 parts per million (ppm) penicillin in the kidney tissue. The established regulatory action level for penicillin in cattle is 0.05 ppm [Title 21, Code of Federal Regulations (21 CFR), Part 556.510]. The presence of this drug at the reported levels in the edible tissue from this animal causes the food to be adulterated under the Act.

Our investigation found that you hold animals under conditions whereby medicated animals bearing potentially harmful drug residues are likely to enter the food supply. For example, you lack an adequate system for assuring that animals medicated by you have been withheld from slaughter for appropriate periods of time to permit depletion of potentially hazardous residues from edible tissue. The investigators found that you have no animal medication records that would identify which animal had been medicated, what type of medication had been used, and what the withdrawal time should be. You need to implement a system in which to record and maintain permanent drug treatment records to’ ensure that illegal tissue residues do not reoccur. You also lack an adequate inventory system for determining the quantities of drugs used to medicate your cows. An accurate drug inventory assures that medications used to treat animals are not being misused and serves as additional assurance that animal treatment records reflect actual dosages administered.

You are also adulterating the veterinary drug Pen-Aquous penicillin G procaine (penicillin) that your firm uses on cows when you fail to use in conformance with its approved labeling. In this case, the proper withdrawal time was not observed per 21 CPR Part 522.1696b. Failure to observe appropriate withdrawal times makes the drug unsafe within the meaning of Section 512(a) and adulterated under Section 501(a)(5).

1.

The above is not intended as an all-inclusive list of violations. As a producer of animals offered for human consumption, you are responsible for assuring that your overall operation and the food products you produce for distribution are in compliance with the law. To avoid future illegal residue violations you should take precautions such as: Implementing a system to identify which animals have been medicated and with what drug(s); and
2.

If an animal has been medicated, implementing a system to withhold the animal from slaughter for an appropriate amount of time to deplete potentially hazardous residues of drugs from edible tissue. If you do not want to hold the medicated animal, then it should not be offered for human food and should be clearly identified and sold as a medicated animal.

You should know that this serious violation of the law may result in FDA taking regulatory action without further notice to you. This action may include, but is not limited to, obtaining a court injunction against you directly or indirectly offering livestock for slaughter for food.

It is necessary for you to take action on this matter now. Please let this office know in writing within 15 working days from the date you receive this letter what steps you are taking to correct the problem. Your response should include each step that has been taken or will be taken to correct prevent these problems from happening again If you need more time, let us know the reason for the delay and when you expect to complete your correction. Please include copies of any available documentation demonstrating that corrections have been made.

Your response should be directed to Richard Harrison, Director, Compliance Branch, at the above address. If you have any questions about the contents of this letter, please call Mr. Harrison at (312) 596-4220.

Sincerely,

/S/
Scott J. MacIntire
District Director

http://www.fda.gov/foi/warning_letters/g4963d.htm

=====================================

September 3, 2004

CERTIFIED MAIL
RETURN RECEIPT REQUESTED

In reply refer to Warning Letter SEA 04-45

Brent Whitesides, President
Whitesides Dairy, Inc.
719 East 700 North
Rupert, Idaho 83350

WARNING LETTER

Dear Mr. Whitesides:

On May 14 and 17, 2004, our investigator inspected your dairy farm located at the 719 East 700 North, Rupert, Idaho. That inspection confirmed that you offered a dairy cow for sale for slaughter as food in violation of Sections 402(a)(2)(C)(ii) and 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act). You also caused the adulteration of an animal drug because the drug was used in a manner that does not conform to the approved use or the extralabel use regulations at Title 21, Code of Federal Regulations, Part 530 (21 CFR 530, copy enclosed). This caused the animal drug to be unsafe under Section 512(a) of the Act and adulterated within the meaning of Section 501(a)(5) of the Act.

On or about December 13, 2003, you sold a dairy cow identified with back tag number [redacted] and further identified as USDA-FSIS lab report #435885, for slaughter as human food to [redacted], for slaughter as human food. U.S. Department of Agriculture (USDA) analysis of tissue samples collected from this cow identified the presence of flunixin at 0.408 parts per million (ppm) in the liver. Flunixin is not approved for use in lactating or dry dairy cows (per 21 C.F.R. 522.970, copy enclosed). A food is adulterated under section 402(a)(2)(C)(ii) of the Act if it contains a new animal drug that is unsafe within the meaning of section 512 of the Act, therefore, the presence of flunixin in the edible tissue of this dairy cow caused the food to be adulterated.

Our investigation also found that you hold animals under conditions that are inadequate to prevent animals bearing potentially harmful drug residues from entering the food supply. For example, you lack an adequate system for determining the medication status of animals you offer for slaughter and you lack an adequate system to assure that medicated animals are withheld from slaughter for appropriate periods of time to permit depletion of potentially hazardous residues of drugs in edible tissues. Foods from animals held under such conditions are adulterated within the meaning of Section 402(a)(4) of the Act.

Extralabel veterinary use of approved veterinary or human drugs is permitted only if it complies with Sections 512(a)(4) and 512(a)(5) of the Act and 21 C.F.R. Part 530. Our investigation found that your firm used flunixin in an extralabel manner but failed to comply with these requirements. Flunixin was prescribed for extralabel use, and that extralabel use caused an illegal drug residue in a dairy cow sold for slaughter as human food. 21 C.F.R. 530.11(c) prohibits any extralabel use that results in a residue which may present a risk to the public health.

Because flunixin was used in an unapproved manner without meeting the requirements for extralabel use set forth in Section 512(a)(4)(A) and 21 C.F.R. Part 530, you rendered the drug unsafe under Section 512 of the Act and adulterated under Section 501(a)(5) of the Act.

It is not necessary for you to have personally shipped an adulterated animal into interstate commerce to be responsible for a violation of the Act. The fact that you offered an adulterated animal to be slaughtered for food where it was held for sale in interstate commerce is sufficient to make you responsible for violations of the Act. Similarly, it is not necessary for you to personally ship an adulterated drug in interstate commerce. The fact that you caused the adulteration of an animal drug that had been shipped in interstate commerce is sufficient to hold you responsible.

The above is not intended to be an all-inclusive list of violations. As a producer of animals that are offered for use as food, you are responsible for ensuring that your overall operations and the food you distribute are in compliance with the law.

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

You should notify this office in writing within 15 working days of receipt of this letter of the specific steps you have taken to correct the noted violations, including an explanation of each step being taken to prevent the recurrence of similar violations. If corrective action cannot be completed within 15 working days, state the reason for the delay and the time within which the corrections will be completed. Also include copies of any available documentation demonstrating that your corrections have been made.

Please send your written reply to the Food and Drug Administration, Attention: Lisa M. Althar, Compliance Officer, 22201 23rd Drive SE, Bothell, WA 98021-4421. If you have any questions regarding this letter, please contact Ms. Althar at (425) 483-4940.

Sincerely,

/S/
Charles M. Breen
District Director

http://www.fda.gov/foi/warning_letters/g4952d.htm

AND THEY WONDER WHY HUMANS HAVE BECOME RESISTANT TO ANTIBIOTICS,
daaaaaaaaaaaaaaaaaaaaaaaaa..............TSS

TSS




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