Antibotic use in Agriculture production

[Tex]

[Texan]

[PORKER]

Judge Orders NY Dairy to Stop Selling Cows

by Dan Flynn |Food safety News Mar 27, 2010

A Wyoming, New York dairy farmer was ordered to stop selling cows for slaughter until he complies with federal law.

U.S. District Court Judge Richard J. Arcara ordered Jerald P. Schumacher, who sells dairy cattle through an auction yard in Pavilion, NY to be slaughtered for human consumption, to cease doing business. The U.S. Food and Drug Administration cited a sole proprietor of the dairy farm, Schumacher, for selling cows that tested positive for illegal residues of antibiotics.

Judge Arcara, who was appointed to the federal bench by former President Ronald Reagan, signed a consent degree of permanent injunction on March 25, ending Schumacher's ability to sell cows for human consumption.

The FDA complaint said Schumacher has sold cows for slaughter for at least 10 years with residues of the antibiotics penicillin and sulfadimethoxine in the animals' edible tissue. The agency also said he illegally gave the cows higher-than-allowed dosages.

"The sale of animals for animal-derived human food products that contain illegal levels of animal drugs poses a significant public health risk," said Dr. Bernadette Dunham, D.V.M., director of FDA's Center for Veterinary Medicine. "FDA will continue to take action against producers who violate federal laws intended to protect the health of the public and of livestock."

The farm was most recently inspected between Oct. 6 and Oct. 21, 2009, and Schumacher was given a written report detailing the violations. After FDA issued a warning letter in 2006 requiring him to abide by the law, violations continued.

The U.S. Department of Agriculture, which has the responsibility for detecting drug residues in beef sold for human consumption, cited Schumacher six times in the past 10 years.

Schumacher also violated the law by failing to keep adequate records of which cows were medicated, according to the complaint.

FDA routinely finds dairy farmers who are selling cows for human consumption that have higher than allowed levels of animal drugs in edible tissues. On March 8, or example, FDA issued a warning letter to the Double B. Dairy, LLC in Wendell, ID for selling an animal for human consumption that had higher than allowed levels of the drug Flunixin in its system.
Tags: antibiotics
Discuss (2) Share
DiscussHarry Hamil
03/27/2010
7:39AM Dan, I find it interesting that we are seeing case after case of dawdling regulators like this finally getting around to doing their jobs and food safety advocates use it as an argument for MORE regulation.

A quick web search shows the wide press coverage this event has gotten showing the FDA in action. It appears to be doing its job.

How about calling for the enforcement of existing regulations?

How about accountability for those regulators that have allowed this to go on for so long?

Instead we hear about how underfunded the FDA is and excuse them.

Food safety will NOT improve materially in this country until the food safety advocates give up their cozy relationship with the regulators, demand that the regulators do their jobs and hold the inspectors and their bosses accountable when they don't.

When will you write that editorial, Dan?
Doc Mudd
03/28/2010
6:27AM *
"...a sole proprietor of the dairy farm, Schumacher... selling cows that tested positive for illegal residues of antibiotics".
*
Hmmm... it turns out to be a small family farmer, not a sinister 'factory farm' chronically and deliberately abusing antibiotics during the past 10 years!
.
Activists would have me believe that only dreadful 'large corporate farms' are capable of such irresponsible behavior, that small mom and pop operations are pure; no inspections or testing necessary for the little local guys. "Buy Local" and "Know Your Farmer" -- sure, good luck with that!

[flounder]

1008 Grinstead Mill Road Dairy

Department of Health and Human Services Public Health Service Food and Drug Administration

March 15, 2010

VIA FEDERAL EXPRESS

WARNING LETTER 10-89924-08

Mr. Kelly Poynter, Sr., Owner 1008 Grinstead Mill Road Cave City, Kentucky 42127-9601

Dear Mr. Poynter:

On October 6, 7, 8, 13, and 14, 2009, the U.S. Food and Drug Administration (FDA) conducted an investigation of your dairy operation located at 1008 Grinstead Mill Road, Cave City, Kentucky 42127-9601. This letter notifies you of the violations of the Federal Food, Drug, and Cosmetic Act (the Act) that we found during our investigation of your operation. You can find the Act and its associated regulations on the Internet through links on FDA's web page at www.fda.gov.

We found that you offered for sale an animal for slaughter as food that was adulterated. Under section 402(a)(2)(C)(ii) of the Act, 21 U.S.C. 342(a)(2)(C)(ii), a food is deemed to be adulterated if it bears or contains a new animal drug that is unsafe under section 512 of the Act, 21 U.S.C. 360b. Further, under section 402(a)(4) of the Act, 21 U.S.C. 342(a)(4), a food is deemed to be adulterated if it has been held under insanitary conditions whereby it may have been rendered injurious to health.

Specifically, our investigation revealed that on or about July 6, 2009, you sold a culled dairy cow, identified with back tag (b)(4) for slaughter as food. On or about July 7, 2009, (b)(4) slaughtered this animal. United States Department of Agriculture, Food Safety and Inspection Service (USDA/FSIS) analysis of tissue samples collected from this animal identified the presence of 35.936 parts per million (ppm) of sulfamethazine residue in the muscle tissue and the presence of 32.294 ppm of sulfamethazine residue in the liver tissue. FDA has established a tolerance of 0.1 ppm for residues of sulfamethazine in the uncooked edible tissues of cattle as codified in Title 21, Code of Federal Regulations (C.F.R.), 556.670 (21 C.F.R. 556.670). The presence of this drug in edible tissue from this animal in this amount causes the food to be adulterated within the meaning of section 402(a)(2)(C)(ii) of the Act, 21 U.S.C. 342(a)(2)(C)(ii).

Our investigation also found that you hold animals under conditions that are so inadequate that medicated animals bearing potentially harmful drug residues are likely to enter the food supply. For example, you failed to maintain treatment records. Food from animals held under such conditions is adulterated within the meaning of section 402(a)(4) of the Act, 21 U.S.C. 342(a)(4).

We also found that you adulterated the new animal drug sulfamethazine. Specifically, our investigation revealed that you did not use sulfamethazine as directed by its approved labeling. Use of this drug in this manner is an extra-label use. See 21 C.F.R. 530.3(a). In addition, the extra-label use of sulfamethazine is prohibited in lactating dairy cows under 21 C.F.R. 530.41(a)(9).

The extra-label use of approved new animal or human drugs in animals is allowed under the Act only if the extra-label use complies with sections 512(a)(4) and (5) of the Act, 21 U.S.C. 360b(a)(4) and (5), and 21 C.F.R. Part 530, including that the use must be by or on the lawful order of a licensed veterinarian within the context of a valid veterinarian/client/patient relationship.

Our investigation found that you administered sulfamethazine to the culled dairy cow identified with back tag (b)(4) without following the dose and withdrawal period as stated in the approved labeling. Sulfamethazine is prohibited for extra-label use in lactating dairy cows by 21 C.F.R. 530.41(a)(9). Furthermore, your extra-label use of sulfamethazine resulted in an illegal drug residue, in violation of 21 C.F.R. 530.11(d). Because your use of this drug was not in conformance with its approved labeling and did not comply with 21 C.F.R. Part 530, you caused the drug to be unsafe under section 512(a) of the Act, 21 U.S.C. 360b(a), and adulterated within the meaning of section 501(a)(5) of the Act, 21 U.S.C. 351(a)(5).

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

You should take prompt action to correct the violations described in this letter and to establish procedures to ensure that these 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 of the steps you have taken to bring your firm into compliance with the law within fifteen (15) working days of receiving this letter. Your response should include each step that has been taken or will be taken to correct the violations and prevent their recurrence. If corrective action cannot be completed within fifteen (15) working days of receiving this letter, 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 written response should be sent to Stephen J. Rabe, Compliance Officer, U.S. Food and Drug Administration, 6751 Steger Drive, Cincinnati, Ohio 45237. If you have any questions about this letter, please contact Mr. Rabe at 513-679-2700 ext. 163.

Sincerely, /S/

Karen Gale Sego Acting District Director Cincinnati District

Cc: Dr. William Thorn University of Kentucky Division of Regulatory Service 103 Regulatory Service Building Lexington, KY 40546-0275



http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm206359.htm


tss

[Mike]

The above animal was probably offerd for sale at a sale barn. After all, it did say she was a cull.

Well........... when sale barn animals are sold at auction, it's "buyer beware" unless stipulations are made before the sale.

When the cull cow buyer bought her, he should have kept her for a time period to cover vaccine withdrawals and should have been "Aware".

To me the buyer did not do his "due diligence", and should be punished instead of the dairy farmer.

All the farmer wanted to do was get rid of her so that he wouldn't have to feed her. Now they act like he's the criminal................

[leanin' H]

Welcome to America in 2010! Ranchers and Farmers get blamed for anything that goes wrong but seldom get the credit for feeding the world. Look at how many people eat healthy, safe food EVERYDAY compared to the fraction of a fraction of 1% who get ill! But nobody ever points that out! One cow with antibiotics residue is justification to slander and demonize an entire industry!

[Mike]

[flounder]

[Mike]

[Bullhauler]

[Oldtimer]

One of the problems with this is it costs us all in the prices we get for our cattle...In talking with some of the buyers they and the slaughterplant have to figure in the cost of what they lose with these animals that get rejected at slaughter because folks don't follow the instructions or break the rules..
And the dairy folks are the worst violators of pumping cows up...

A couple of the Lauras Lean (no antibiotics) buyers have told me that program is really tough on checking-- the reason sometimes its nice when you know the buyer- and they know you're not of the type that will try to slip something thru and its worth a few more cents...

[Big Muddy rancher]