Fight to curtail antibiotics in animal feed

Fight to curtail antibiotics in animal feed
Sabin Russell, Chronicle Medical Writer

Monday, January 28, 2008


Consumer advocates have been campaigning for years to curb the use of antibiotics in agriculture, citing studies that show that 70 percent of all U.S. antibiotics are administered in low doses - not to treat disease, but to promote the growth of pigs, sheep, chicken and cattle.

Low doses of antibiotics in animal feeds have been shown to boost the speed of food-to-muscle conversion by 5 percent, and can prevent the spread of disease in the tight quarters of modern factory farms.

But as early as 1963, British researchers tied the emergence of drug-resistant strains of salmonella in humans to antibiotics fed to cattle. Among the drugs routinely found in animal feed are erythromycin, penicillin and streptomycin. Critics warn that the use of antibiotics in feed at low dosages helps to breed resistant bacteria in the gut of farm animals - threatening the future of these drugs for use in animals or humans.

Major antibiotic classes such as tetracyclines and the Cipro-like fluoroquinolones have already been compromised, according to Keep Antibiotics Working, a coalition backed by environmental groups and the American Medical Association.

The stakes are high. The Union of Concerned Scientists calculated in 2001 that U.S. farm interests were using 24.6 million pounds of anti-microbials - almost 40 percent higher than industry estimates.

Ron Phillips, vice president of the Animal Health Institute, a Washington trade group for agricultural drugmakers, maintains that growth promotion accounts for only 4.5 percent of antibiotic consumption in agriculture. The rest are used to prevent, treat or control the spread of disease. "Antibiotics," he says, "are a net positive for both animal health and human health."

After antibiotics were banned from animal feed in Europe beginning in 1995, Phillips said, farmers there found they had to use more antibiotics to care for illnesses that cropped up in their livestock.

Keep Antibiotics Working nevertheless is pushing for a federal ban on antibiotics in feed. Introduced by Sens. Edward Kennedy, D-Mass, and Olympia Snow, R-Maine, the "Preservation of Antibiotics for Medical Treatment Act" would phase out in two years antibiotics deemed "important in human medicine."

In response to pressure from consumer groups, McDonald's declared four years ago its intention to phase out the purchase of meats from chicken and livestock fed the drugs to promote growth. The Food and Drug Administration in 2005 banned the use of a Cipro-like drug, Baytril, to treat bacterial infections in poultry, after drug-resistant strains of Campylobacter - a common food-poisoning organism - were found in chicken. Cases of Cipro-resistant Campylobacter were also rising in humans.

The FDA is considering an application for approval of the antibiotic cefquinome, a proposed veterinary drug that is similar to the human drug cefepime. In the fall of 2006, an FDA advisory committee recommended against approval.

"It was surprising what the committee did, because it was stacked with veterinarians and animal science people," said Stephen Roach, director of public health programs for Keep Antibiotics Working.

"The USDA is very reluctant to say that antibiotic use causes a problem, and the FDA has traditionally been in the middle. But I feel that in the last several years, they have been more accommodating to industry," said Roach.

A final decision on approving cefquinome is still pending.


E-mail Sabin Russell at srussell@sfchronicle.com.


http://www.sfgate.com/cgi-bin/article.cgi?f=/c/a/2008/01/28/MNSTUGD8E.DTL


Public Health Service
Food and Drug Administration

Baltimore District Office
6000 Metro Drive
Suite 101
Baltimore, MD 21215-3215
Telephone: (410) 779-5454



FEI: 3000203759

January 16 , 2008

WARNING LETTER

08-BLT-03

CERTIFIED MAIL
RETURN RECEIPT REQUESTED
Mr. Francis H. Roderick
Old Carolina Farms
10802 Cook Brothers Road
Ijamsville, Maryland 21754

Dear Mr. Roderick:

An inspection of your dairy operation located at 10802 Cook Brothers Road, Ijamsville, Maryland, conducted by a representative of the U.S. Food and Drug Administration (FDA) between October 16, 2007, and November 27, 2007, confirmed that you offered a bob veal calf for sale for slaughter as food that was adulterated under sections 402(a)(2)(C)(ii) [21 U.S.C. § 342(a)(2)(C)(ii)] and 402(a)(4) [21 U.S.C. § 342(a)(4)] of the Federal Food, Drug, and Cosmetic Act (the Act) . The inspection also revealed that you caused the new animal drug, [redacted] (sulfamethazine) [redacted] to become unsafe under section 512(a) [21 U.S.C. § 360b(a)] of the Act and adulterated within the meaning of section 501(a)(5) [21 U.S.C. § 351(a)(5)] of the Act. In addition, the inspection revealed that you provided a false guaranty, a prohibited act under section 301(h) of the Act [21 U.S.C. § 331(h)], You can find the Act and its associated regulations on the Internet through links on the FDA's web page at
www.fda.gov.

On or about July 25, 2007, you consigned a bob veal calf, identified with tag [redacted], for slaughter as food an [redacted]. On or about July 26, 2007, this animal was slaughtered at [redacted] United States Department of Agriculture, Food Safety and Inspection Service (USDA/FSIS) analysis of tissue samples collected from that animal identified the presence of 131.89 parts per million (ppm) of sulfamethazine in the liver tissue and 179.88 ppm of sulfarnethazine in the muscle tissue of this animal. A tolerance of 0.1 ppm has been established for residues of sulfamethazine in the edible tissues of cattle as codified in Title 21, Code of Federal Regulations, section 556.670 [21 C.F.R. 556.670]. The presence of this drug in these amounts in edible) tissues from this animal causes the food to be adulterated within the meaning of section 402(a)(2)(C)(ii)[(21 U.S.C. § 342(a)(2)(C)(ii)] of the Act.

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. You lackS an adequate system to ensure that animals medicated by you have been withheld from slaughter for appropriate periods of time to permit depletion of potentially hazardous residues of drugs from edible tissues. 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) [21 U.S.C. § 342(a)(4)] of the Act.

Furthermore, on or about April 9, 2001, you provided [redacted] with a signed certification, which states that you will not supply [redacted] with any livestock that is "adulterated within the meaning of the Federal Food (Drug] and Cosmetic Act (i.e., none of the cattle or other ruminants will have been fed any feed containing protein derived from mammalian tissues, e.g. meat and bone meal, as that term is defined in 21 C.F.R. 589.2000 and none of the livestock will have an illegal level of drug residues)." On July 25, 2007, you delivered to [redacted] a bob veal calf containing illegal levels of sulfamethazine residues. Providing such a false guaranty is a prohibited act under section 301(h) [21 U.S.C. § 331(h)) of the Act.

In addition, you adulterated [redacted] (sulfamethazine) [redacted] within the meaning of section 501(a)(5) [21 U.S.C. § 351(a)(5)] of the Act when you failed to use the drug in conformance with its approved labeling. "Extralabel use," i.e., the actual or intended use of a drug in an animal in a manner that is not in accordance with the approved labeling, is only permitted if the use is by or on the lawful order of a licensed veterinarian within the context of a valid veterinarian/client/patient relationship. The extralabel use of approved veterinary or human drugs must comply with sections 512(a)(4) [21 U.S.C. § 360b(a)(4)] and 512(a)(5) [21 U.S.C. § 360b(a)(5)] of the Act and 21 C.F.R. Part 530. Our investigation found that your extralabel use of [redacted] (sulfamethazine) [redacted] failed to comply with these requirements. For example, you administered these [redacted] (sulfamethazine) [redacted] without following the withdrawal period set forth in the approved labeling and you did so without the supervision of a licensed veterinarian, in violation of 21 C.F.R. 530.11(a). Furthermore, your extralabel use resulted in an illegal drug residue, in violation of 21 C.F.R. 530.11(d). Because your extralabel use of this drug was not in compliance with 21 C.F.R. Part 530, the drug was unsafe under section 512(a) [21 U.S.C. § 360b(a)} of the Act and your use caused it to be adulterated within the meaning of section 501(a)(5) [21 U.S.C. § 351(a)(5)] of the Act.

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 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 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, 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 Steven B. Barber, Compliance Officer, U.S. Food and Drug Administration, 6000 Metro Drive, Suite 101, Baltimore, Maryland 21215. If you have any questions about this letter, please contact Mr. Barber at 410-779-5134.

Sincerely yours,

/S/

Kirk Sooter
Acting District Director

cc: Dr. David F. Vogt
USDA, APHIS, VS
1598 Whitehall Road, Suite A
Annapolis, Maryland 21401

FSIS District Office
5601 Sunnyside Avenue Suite 1-2288 B
Beltsville, Maryland 20705

[redacted]

[redacted]


http://www.fda.gov/foi/warning_letters/s6642c.htm


Public Health Service
Food and Drug Administration

New York District
300 Pearl Street, Suite 100
Buffalo, NY 14202



January 11, 2008

WARNING LETTER NYK 2008-05

CERTIFIED MAIL
RETURN RECEIPT REOUESTED

Aaron G. Poupore, Co-Owner/Herdsman
Papas Dairy, LLC
322 Wheeler Road
North Bangor, New York 12966

Dear Mr. Poupore:

An inspection of your dairy operation located at 322 Wheeler Road, North Bangor, New York, conducted by a representative of the U.S. Food and Drug Administration (FDA) on October 17-19, 2007, confirmed that you offered a cow for sale for slaughter as food that was adulterated under sections 402(a)(2)(C)(ii) [21 U.S.C. § 342(a)(2)(C)(ii)] and 402(a)(4) [21 U.S.C. § 342(a)(4)] of the Federal Food, Drug, and Cosmetic Act (the Act). The inspection also revealed that you caused the new animal drugs, ALBON® (sulfadimethoxine) boluses and penicillin G procaine, to become unsafe under section 512 [21 U.S.C. § 360b] of the Act and adulterated within the meaning of section 501(a)(5) [21 U.S.C. § 351(a)(5)] of the Act. You can find the Act and its associated regulations on the Internet through links on FDA's web page at www.fda.gov.

On or about September 11, 2007, you consigned a cow identified with farm [redacted] for slaughter as food to [redacted] where it was picked up the next day by [redacted]. On or about September 13, 2007, this animal was slaughtered at [redacted] United States Department of Agriculture, Food Safety and Inspection Service (USDA/FSIS) analysis of tissue samples collected from that cow identified the presence of 0.60 parts per million (ppm) of sulfadimethoxine in liver tissue and 0.41 ppm of sulfadimethoxine in muscle tissue. A tolerance of 0.1 ppm has been established for residues of sulfadimethoxine in the uncooked edible tissues of cattle as codified in Title 21, Code of Federal Regulations, Section 556.640(21 C.F.R. 556.640). The presence of this drug in these amounts in the uncooked edible tissues of this animal causes the food to be adulterated within the meaning of section 402(a)(2)(C)(ii) [21 U.S.C. § 342(a)(2)(C)(ii)] of the Act.

Our investigation also found that you hold animals under conditions that are so in adequate that medicated animals bearing potentially harmful drug residues are likely to enter the food supply. You lack an adequate system to ensure that animals medicated by you have been withheld from slaughter for appropriate periods of time to permit depletion of potentially hazardous residues of drugs from edible tissues. For example, you failed to maintain complete treatment records. Food from animals held under such conditions is adulterated within the meaning ofsection402(a)(4)[21 U.S.C. §342(a)(4)] of the Act.

In addition, you adulterated Albon® sulfadimethoxine boluses and Penicillin G Procaine within the meaning of section 501(a)(5) [21 U.S.C. § 351(a)(5)] of the Act when you failed to use these drugs in conformance with their approved labeling. "Extralabel use," i.e., the actual or intended use of a drug in an animal in a manner that is not in accordance with the approved labeling, is only permitted if the use is by or on the lawful order of a licensed veterinarian within the context of a valid veterinarian/client/patient relationship. The extralabel used of approved veterinary or human drugs must comply with sections 512(a)(4) [21 U.S.C. § 360b(a)(4)] and 512(a)(5) [21 U.S.C. § 360b(a)(5)] of the Act and 21 C.F.R. Part 530. Our investigation found that your extralabel use of Albon® sulfadimethoxine boluses and Penicillin G Procaine failed to comply with these requirements.

For example, you administered Albon® sulfadimethoxine without following the dosage level set forth in the approved labeling and you did so without the supervision of a licensed veterinarian, in violation of 21 C.F.R. 530.11(a). Furthermore,your extralabel use resulted in an illegal residue, in violation of 21 C.F.R. 530.11(d). In addition, you administered IBA Penicillin G Procaine Injectable Suspension to cows on your farm without following the dosage level, route of administration, and duration of treatment set forth in the approved labeling, and you did so without the supervision of a licensed veterinarian, in violation of 21 C.F.R. 530.11(a). Because your extralabel use of these drugs was not in compliance with 21 C.F.R. Part 530, the drugs were unsafe under section 512(a) [21 U.S.C. § 360b(a)] of the Act and your use caused them to be adulterated within the meaning of section 501(a)(5) [21 U.S.C. § 351(a)(5)] of the Act.

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 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 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, 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 Edward W. Thomas,Director Compliance Branch, U.S. Food and Drug Administration, 300 Pearl Street, Suite 100, Buffalo, New York 14202. If you have any questions about this letter, please contact Mr. Thomas at (716) 541-0316

Sincerely yours,

/S/

Otto D. Vitillo
Director, New York District


http://www.fda.gov/foi/warning_letters/s6637c.htm


What Do We Feed to Food-Production Animals? A Review of Animal Feed
Ingredients and Their Potential Impacts on Human Health


Amy R. Sapkota,1,2 Lisa Y. Lefferts,1,3 Shawn McKenzie,1 and Polly Walker1
1Johns Hopkins Center for a Livable Future, Bloomberg School of Public
Health, Baltimore, Maryland, USA; 2Maryland Institute for
Applied Environmental Health, College of Health and Human Performance,
University of Maryland, College Park, Maryland, USA;
3Lisa Y. Lefferts Consulting, Nellysford, Virginia, USA


snip...



Table 1. Animal feed ingredients that are legally used in U.S. animal feeds



Animal


Rendered animal protein from Meat meal, meat meal tankage, meat and bone
meal, poultry meal, animal the slaughter of food by-product meal, dried
animal blood, blood meal, feather meal, egg-shell production animals and
other meal, hydrolyzed whole poultry, hydrolyzed hair, bone marrow, and
animal animals digest from dead, dying, diseased, or disabled animals
including deer and elk Animal waste Dried ruminant waste, dried swine waste,
dried poultry litter, and undried processed animal waste products


snip...


Conclusions


Food-animal production in the United States has changed markedly in the past
century, and these changes have paralleled major changes in animal feed
formulations. While this industrialized system of food-animal production may
result in increased production efficiencies, some of the changes in animal
feeding practices may result in unintended adverse health consequences for
consumers of animal-based food products. Currently, the use of animal feed
ingredients,
including rendered animal products, animal waste, antibiotics, metals, and
fats, could result in higher levels of bacteria, antibioticresistant
bacteria, prions, arsenic, and dioxinlike compounds in animals and resulting
animal-based food products intended for human consumption. Subsequent human
health effects among consumers could include increases in bacterial
infections (antibioticresistant and nonresistant) and increases in the risk
of developing chronic (often fatal) diseases
such as vCJD. Nevertheless, in spite of the wide range of potential human
health impacts that could result from animal feeding practices, there are
little data collected at the federal or state level concerning the amounts
of specific ingredients that are intentionally included in U.S. animal feed.
In addition, almost no biological or chemical testing is conducted on
complete U.S. animal feeds; insufficient testing is performed on retail meat
products; and human health effects data are not appropriately linked to this
information. These surveillance inadequacies make it difficult to conduct
rigorous epidemiologic studies and risk assessments
that could identify the extent to which specific human health risks are
ultimately associated with animal feeding practices. For example, as noted
above, there are insufficient data to determine whether other human
foodborne bacterial illnesses besides those caused by S. enterica serotype
Agona are associated with animal feeding practices. Likewise, there are
insufficient data to determine the percentage of antibiotic-resistant human
bacterial infections that are attributed to the nontherapeutic use of
antibiotics in animal feed. Moreover, little research has been conducted to
determine whether the use of organoarsenicals in animal feed, which can lead
to elevated levels of arsenic in meat products (Lasky et al. 2004),
contributes to increases in cancer risk. In order to address these research
gaps, the following principal actions are necessary within the United
States: a) implementation of a nationwide reporting system of the specific
amounts and types of feed ingredients of concern to public health that are
incorporated into animal feed, including antibiotics, arsenicals, rendered
animal products, fats, and animal waste; b) funding and development of
robust surveillance systems that monitor biological, chemical, and other
etiologic agents throughout the animal-based food-production chain “from
farm to fork” to human health outcomes; and c) increased communication and
collaboration among feed professionals, food-animal producers, and
veterinary and public health officials.


REFERENCES...snip...end


Sapkota et al.
668 VOLUME 115 NUMBER 5 May 2007 • Environmental Health Perspectives


http://www.pubmedcentral.nih.gov/picrender.fcgi?artid=1867957&blobtype=pdf


MRSA/VRSA

http://staphmrsa.blogspot.com/


TSS