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Antibotic use in Agriculture production

Providence Dairy, LLC 3/17/10

Department of Health and Human Services Public Health Service Food and Drug Administration Detroit District 300 River Place SUite 5900 Detroit, MI 48207 Telephone: 313-393-8100 FAX: 313-393-8139

WARNING LETTER 2010-DT-09

March 17, 2010

VIA FEDERAL EXPRESS

Mr. Arie Jan de Jong, Owner Providence Dairy, LLC 8801 East County Road 800 North Twelve Mile, Indiana 46988-9314

Dear Mr. Jan de Jong:

On September 10 and 28, 2009 the U.S. Food and Drug Administration (FDA) conducted an investigation of your dairy operation located at 8801 East County Road 800 North, Twelve Mile, Indiana 46988, 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 animals for slaughter as food that were 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. 360(b). 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 the dates of May 26, 2009, June 1, 2009, June 18, 2009, June, 25, 2009, and July 23, 2009, you sold cows identified with ear tag numbers (b)(4) respectively, for slaughter as food. On or about May 27, 2009, June 2, 2009, June 23, 2009, June, 26, 2009, and July 24, 2009, (b)(4) slaughtered the cows identified with ear tag numbers" (b)(4) and (b)(4) respectively. United States Department of Agriculture, Food Safety and Inspection Service (USDA/FSIS) analysis of tissue samples collected from each of these animals identified the presence of the following drugs in parts per million (ppm):

Cow Ear Tag

Cow House Tag Slaughter Date Drug(s)

Tissue Analyzed Level Found (ppm) (b)(4) (b)(4) 7/24/2009

Penicillin Kidney 0.11 (b)(4) (b)(4) 6/02/2009

Penicillin Kidney 0.12 (b)(4) (b)(4)

Sulfadimethoxine Liver 0.50 (b)(4) (b)(4) 6/26/2009

Neomycin Kidney 21.47 (b)(4) (b)(4)

Sulfadimethoxine Liver 0.124 (b)(4) (b)(4) 5/27/2009

Neomycin Kidney 12.44 (b)(4) (b)(4) 6/23/2009

Flunixin Liver 0.2428


FDA has established a tolerance for each of these new animal drugs as follows: 0.05 ppm for residues of penicillin in uncooked edible tissue of cattle as codified in Title 21, Code of Federal Regulations, Section 556.510(a) (21 C.F.R. § 556.510(a)); 0.125 ppm for residues of flunixin in liver tissue of cattle as codified in 21 C.F.R. § 556.286(b)(1)(i); 0.1 ppm for residues of sulfadimethoxine in the uncooked edible tissue of cattle as codified in 21 C.F.R. § 556.640(b)(1); and, 7.2 ppm for residues of neomycin in kidney tissue of cattle as codified in 21 C.F.R. § 556.430(b)(1). The presence of these drugs in edible tissue from these animals in these amounts cause the food to be adulterated under 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 complete 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 drugs penicillin, flunixin, neomycin and sulfadimethoxine. Specifically, our investigation revealed that you did not use these drugs as directed by their approved labeling. Use of these drugs in this manner is an extralabel use in violation of 21 C.F.R. § 530.3(a).

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. 360(b)(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 penicillin to the animals with ear tag numbers (b)(4) and (b)(4) without following the dose as stated in the approved labeling. Your extralabel uses of penicillin were not under the supervision of a license veterinarian, in violation of 21 C.F.R. § 530.11(a) and your extralabel uses of penicillin resulted in illegal drug residues, in violation of 21 C.F.R. § 530.11(d). Our investigation found that you administered flunixin to the animal with ear tag number and the animal with ear tag number (b)(4) without following the route of administration as stated in the approved labeling. Your extralabel uses of flunixin were not under the supervision of a license veterinarian, in violation of 21 C.F.R. § 530.11(a) and your extralabel uses of flunixin resulted in illegal drug residues, in violation of 21 C.F.R. § 530.11(d). Our investigation found that you administered neomycin to the animals with ear tag numbers (b)(4) without following the animal class as stated in the approved labeling. Your extralabel use of neomycin was not under the supervision of a license veterinarian, in violation of 21 C.F.R. § 530.11 (a) and your extralabel use of neomycin resulted in illegal drug residues, in violation of 21 C.F.R. § 530.11(d). Our investigation found that you administered sulfadimethoxine to the animal with ear tag number 12005 without following the indication as stated in the approved labeling. Sulfadimethoxine is prohibited for extralabel use in lactating dairy cattle by 21 C.F.R. § 530.41(a)(9) and your extralabel use of sulfadimethoxine resulted in an illegal drug residue, in violation of 21 C.F.R. § 530.11(d). Because your use of these drugs were not in conformance with their approved labeling and did not comply with 21 C.F.R. Part 530, you caused the drugs 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).

Our investigation also revealed that on or about March 18, 2003, you provided (b)(4) with a signed "Livestock Owner Certificate" stating that none of the livestock supplied to (b)(4) will have an illegal level of drug residues. This signed agreement covered the cows identified with ear tag numbers (b)(4) which were found to contain violative residues of penicillin, neomycin/sulfadimethoxine, flunixin, penicillin/sulfadimethoxine, and neomycin, respectively. Providing such a false guaranty is prohibited by section 301(h) of the Act, 21 U.S.C. 331(h). You should take appropriate actions to ensure that this violation does not recur.

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 Tina M. Pawlowski, Ph.D., Compliance Officer, U.S. Food and Drug Administration, 300 River Place, Suite 5900, Detroit, MI 48207. If you have any questions about this letter, please contact Compliance Officer Pawlowski at (313) 393-8127 or by email at [email protected]..

Sincerely,

/a/

Joann M. Givens District Director Detroit District Office

http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm206548.htm
 
Two antibiotics taken out of US market

08 Apr 2010
The US Food and Drug Administration has written a letter to stakeholders in agriculture to remind them of withdrawal of neomycin and oxytetracyline from the market.
Daniel G. McChesney, FDA Director, Office of Surveillance and Compliance at the Center for Veterinary Medicine in a letter reminds stakeholders that "Type A medicated articles containing neomycin and oxytetracydine […] should be removed from the market by April 2, 2010, and that Type B and Type C medicated feeds should be removed by October 2, 2010."

The type of drugs are described in21 CFR 558.15 (§ 558.15).

The two sponsors of fixed-ratio Type A medicated articles containing neomycin and oxytetracydine, Phibro Animal Health and Pennfield Oil Co., have each submitted revised labelling that removed unsupported intended uses.

The conditions of use approved in these supplemental applications were codified in 21 CFR 558.455 (§ 558.455), in 2006 for Phibro Animal Health and in 2009 for Pennfield Oil Co.

These amendments to the animal drug regulations completed each application's transition from interim marketing status and rendered inaccurate and obsolete the conditions of use codified in § 558.15.

McChesney furthermore reminds stakeholders that as a result of the regulations in § 558.455:
only Type A medicated articles containing neomycin and oxytetracydine in a 1:1 ratio may be used for the uses reflected in § 558.455;
neomycin sulfate is the only chemical form of neomycin approved for feed use in combination with oxytetracydine;
combination medicated feeds containing neomycin and oxytetracydine are not approved for use in chickens or turkeys producing eggs for human consumption; and
combination medicated feeds containing neomycin and oxytetracydine are not approved for use in baby pigs, (e.g., in swine milk replacers).
On March 31, 2010, FDA published a final rule in the Federal Register that removed the obsolete regulations in § 558.15.
 
FDA Says Indiana Dairy Misused Antibiotics
by Dan Flynn | Apr 10, 2010
A Central Indiana dairy farm sold a small herd of cattle for slaughter as food that tests showed had higher than permissible levels of various antibiotics in kidney and liver tissues, the U.S. Food and Drug Administration (FDA) says.

FDA sent a "Warning Letter" to Providence Dairy LLC in Twelve Mile, IN on March 17 to put it on notice about its sales of animals with illegal levels of drug residues. The agency asked the dairy to respond within 15 working days.

Providence Dairy sold seven cows on various dates last spring and summer that were then subjected to tissue testing by the U.S. Department of Agriculture 's (USDA's) Food Safety and Inspection Service (FSIS).

FDA has established tolerance levels for animal drugs. For Penicillin, 0.05 parts per million (ppm) for residue in uncooked edible tissues is the allowed tolerance level. Penicillin levels of 0.11 and 0.12 were found in two cows sold by Providence.

The tolerance level for Sulfadimethoxine is 0.1 ppm in the uncooked edible tissue of cattle. Results from two cows sold by Providence were 0.50 ppm and 0.124 ppm. Both of the excessive results came from kidney tissue samples.

Neomycin is tolerated up to 7.2 ppm. The tissue samples of kidneys from two Providence cows returned test results of 21.47 ppm and 12.44 ppm.

The tolerance level for Flunixin in liver tissue of cattle is 0.125 ppm. The cow Providence sold returned a 0.2428 level.

"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," Joann M. Givens, FDA's Detroit district director, wrote to the Providence Dairy.

"For example, you failed to maintain complete 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 drugs penicillin, flunixin, neomycin and sulfadimethoxine. Specifically, our investigation revealed that you did not use these drugs as directed by their approved labeling. Use of these drugs in this manner is an extralabel use in violation of 21 C.F.R. § 530.3(a)," she added.

FDA said the dairy had a signed "Livestock Owner Certificate" stating that none of the livestock sold for slaughter for food would have illegal levels of drug residues.

"Providing such a false guaranty is prohibited by section 301(h) of the Act, 21 U.S.C. 331(h)," Givens wrote. "You should take appropriate actions to ensure that this violation does not recur."
 
Not sure how you like your steaks, but here in the USA, here is how we get them ;


"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."


Wednesday, April 14, 2010

FSIS National Residue Program for Cattle Audit Report 24601-08-KC March 2010 U.S. Department of Agriculture Office of Inspector General


http://staphmrsa.blogspot.com/2010/04/fsis-national-residue-program-for.html


Monday, April 12, 2010

Senator Kay Bailey Hutchison says NO to safer food and S. 510 FDA Food Safety Modernization Act of 2009


http://fdafailedus.blogspot.com/2010/04/senator-kay-bailey-hutchison-says-no-to.html



TSS
 
FDA Finds Animal Drug Abuse in 4 States
by Dan Flynn | May 13, 2010
Feed lots, dairies and feed mills sure like those antibiotic drugs for animals.

The Food and Drug Administration (FDA) charged four animal agriculture practitioners in warning letters sent out April 21-30 with abusing mostly antibacterial drugs. Misuse of animal drugs may mean antibiotics are getting into the human food supply at levels higher than tolerated by FDA.

FDA warning letters went out to agricultural operations in Florida, Washington state, Illinois, and Nebraska.

The first two warning letters went out to dairies: Mayo, FL-based Land Dairy Inc. and Rochester, WA-based Elma Dairy, LLC. Both were subjected to recent FDA investigations.

FDA said Land Dairy sold a dairy cow with liver tissues containing 0.2 parts per million (ppm) of sulfamethazine. FDA considers the presence of any amount of the sulfa-based antibiotic in the edible tissues to be adulterated within the meaning federal law.

"Our investigation also found you hold animals under conditions that are so inadequate that medicated animals bearing potentially harmful drug residues are likely to enter the food supply," Emma R. Singleton, FDA's Florida district director, wrote.

FDA is not happy with Land's recording keeping and inventory systems and further said the dairy was using the sulfa drug in ways not provided for on its label.

On the opposite corner of the country, Elma Dairy sold a dairy cow in Washington State where tissue sampling discovered the presence of desfuroylceftiofur or DFC of 1.04 ppm in kidney tissue and 0.44 of sulfadimethoxine in liver tissue.

FDA's tolerance level for DFC in any edible tissue is 0.4 ppm and 0.1 ppm for sulfadimethoxine.

"Our investigation found that you administered ceftiofur hydrochloride to a dairy cow without following the withdrawal period as stated in the approved labeling," Charles Breen, FDA's Seattle district director, wrote Elma.

The U.S. Department of Agriculture's Food Safety and Inspection Service (FSIS) conducts tissue sample tests after cows are slaughtered for human consumption.

Tissue from a beef heifer sold by the Martin Food Lot in Harrisburg, IL was subjected to those tests and was the presence of 38.855 ppm of sulfamethazine and 0.1781 ppm of flunixin were found, both in the liver tissue. FDA's tolerances for these drugs are 0.1 ppm of negligible residues of sulfamethazine in the uncooked edible tissues of cattle, and 0.125 ppm (or 125 parts per billion) of flunixin in the liver.

"We also found you adulterated the new animal drug flunixin," wrote Scott J. MacIntire, FDA's Chicago district director. He said Martin did not use the drug as directed on the label and did so without the lawful order of a licensed veterinarian.

Finally, at Darr Feedlots Inc. in Cozad, NE, the drugs chlortetracycline and monensin were being used in an unapproved combination in medicated animal feed. The first of the two drugs is used to control a single cell parasite.

FDA said when combined in cattle feed the two drugs are unsafe.
 

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