NEW YORK, Feb. 10, 2010
Denmark's Case for Antibiotic-Free Animals
Katie Couric Reports on Denmark's Ban on Antibiotics in Livestock
CBS) They call it the "Danish Experiment" - a source of pride for the country's 17,000 farmers. CBS Evening News Anchor Katie Couric reports how unlike industrial farms in the U.S., which use antibiotics to promote growth and prevent disease, farmers in Denmark use antibiotics sparingly, only when animals are sick.
The experiment to stop widespread use of antibiotics was launched 12 years ago, when European studies showed a link between animals who were consuming antibiotic feed everyday and people developing antibiotic resistant infections from handling or eating that meat.
"We don't want to use more medicine than needed, and a lot of the medicine that is given is not needed," said Soren Helmer. Helmer is a second-generation pig farmer whose sows produce more than 30,000 pigs a year. When the ban started, he and his father thought the industry would suffer.
"We thought we could not produce pigs as efficient as we did before," Helmer said. "But that was proven wrong."
Since the ban, the Danish pork industry has grown by 43 percent - making it one of the top exporters of pork in the world. All of Europe followed suit in 2006. But the American Pork Industry doesn't want to.
"What we've seen in Denmark and other countries is that they actually have had some increases in cost of what it takes to produce a pig," said Liz Wagstrom, a veterinarian with the National Pork Board.
"So it's not that unqualified a success. If we did the same thing in the United States, we would likely see small producers pushed out of business, we'd have more sick and dying pigs, and none of that would result in a benefit to the U.S. consumer."
Without growth-promoting antibiotics, it only costs $5 more for every 100 pounds of pork brought to market in this country.
Animal Antibiotics a Threat?
That's a small price for public health, says Dr. Ellen Silbergeld, who has been studying the antibiotic resistance link between livestock and people for the past decade.
"I think the Danish and European experience indicate that there will be real and measurable public health benefits," she said. "There'll be improvements in food safety and actually in the prevalence of drug resistant infections in people."
Pew Campaign on Human Health and Industrial Farming
According to one study, when different countries introduced certain antibiotics on farms, a surge occurred in people contracting antibiotic resistant intestinal infections one to two years later. One infection, Campylobacter, increased 20 percent in Denmark and 70 percent in Spain.
After the ban, a Danish study confirmed that removing antibiotics from farms drastically reduced antibiotic-resistant bacteria in animals and food.
Danish scientists believe if the U.S. doesn't stop pumping its farm animals with antibiotics, drug-resistant diseases in people will only spread.
"It's not going to be a time bomb that goes off like this," said Dr. Frank Aarestrup, of the Danish Food Institute at the University of Denmark. "It's something that's slowly getting more and more complicated, more difficult for us to actually treat infections.
Rep. Slaughter's "Preservation of Antibiotics for Medical Treatment Act"
Some American food producers agree.
"It's just gone too far," said Stephen McDonnell, CEO Applegate Farms.
"What most bothers you about the way industrial farmers in this country currently operate," Couric asked.
"We use too many antibiotics, we use too many growth promotants," McDonnell replied. "The singular focus is to create cheap meat. That's not always the best thing for the health of the Americans who buy it."
"We think with some subtle changes - giving them more space, feeding them a good diet, and not stressing them out by growing them too quickly - you don't even need to use antibiotics," McDonnell added.
McDonnell helps farmers like Duane Koch kick the habit.
"How long have you been raising turkeys, Duane, without using antibiotics," Couric asked.
"We started running without antibiotics roughly 14 years ago," Koch replied.
"Does it make you feel better doing it this way," Couric asked.
"Yeah," Koch said. "Because really, from using the antibiotics so long, a lot of them didn't work well any way anymore."
Today his 18 poultry farms scattered throughout Pennsylvania are more profitable than when he used antibiotics.
Koch says it costs very little to convert a farm to antibiotic-free. And it doesn't cost consumers much more either. People buying antibiotic free turkey thigh meat will spend around $1.40 versus $1.20 for conventionally raised birds.
Koch says higher-quality feed and improving living conditions, his birds are naturally healthier.
Couric asked, "What's the importance of giving them more space?"
"That's just our natural growth promotants," he said. "By giving them more space, we can get weights that are really close to what they're getting, you know, with the growth promotants."
Because farmers are raising livestock successfully without growth-promoting antibiotics - from Lebanon, Pennsylvania to outside Copenhagen - public health officials in this country say this is an idea whose time has come.
"We have identified here that we're talking about a public health issue, that the overuse of antibiotics on farms does pose a risk to human health," said Joshua Sharfstein of the FDA.
The FDA has for the first time come out against using certain antibiotics to promote growth in livestock.
And pending legislation in Congress would ban some types of antibiotics used to treat humans from being administered to healthy farm animals.
http://www.cbsnews.com/stories/2010/02/ ... 5054.shtml
Hello Ms. Couric Ma'am !
Thank you very much on that show of yours about antibiotics in meat, the over-use-of, and resistance there from, to humans and animals. Nice Job! The public is just oblivious to what is going on with the meat they eat. I thought the Danish study was remarkable, and proves what can be done, if an industry wants to do something. sadly, here in the USA, all the industry cares about is their bottom dollar. I have been most concerned about hormones, antibiotics, TSE aka mad cow disease, and other pathogens in meat for some time. I lost my mother to the Heidenhain Variant of Creutzfeldt Jakob Disease, considering North America is home to c-BSE, h-BSE, and the l-BSE in cattle, who is it to say that it should look exactly like the UK c-BSE ??? THEN, my last neck surgery, I believe my neurosurgeon did use a special bone grinder and a few extra precaustion, due to my Mother having died from hvCJD, and they damn near kill me with MRSA. Looking into to that, I was amazed at the amount of antibiotics and hormones that go into cattle due to the fact they are to sick to slaughter. 8 weeks vancomycin straight to the heart via long pic line made a believer in me. now I know some how I was infected probably via the operating arena, there were 7 other's the same week from the same surgcial unit, I was told later (this was in 2002), but we have become immune to these medicines due to over use, not only in humans but animals for human consumption as well. on most any given tuesday you can find something like this ;
October 9,2009
WARNING LETTER
CERTIFIED MAIL RETURN RECEIPT REQUESTED
Keith L. Schaeffer Owner Evergreen Acres Dairy, LLC 26162 240th Street Paynesville, Minnesota 56362
Dear Mr. Schaeffer:
Refer to MIN 10 - 01
On April 23 and May 4,2009, the Minnesota Department of Agriculture conducted an investigation of your dairy operation located at 26162 240th Street, Paynesville, Minnesota. This letter notifies you of the violations of the Federal Food, Drug, and Cosmetic Act (the Act) that were found during the 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.
The investigation 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, the investigation revealed that on or about September 16, 2008, you sold a dairy cow identified with your farm ear tag #(b)(4)for slaughter as food. On or about September 17, 2008, (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 neomycin at 31.05 parts per million (ppm) in kidney tissue. FDA has established a tolerance of 7.2 ppm neomycin residue in kidney tissue as codified in Title 21, Code of Federal Regulations, Section 556.430(b)(1), 21 C.F.R. 556.430(b)(1). The presence of this drug in kidney 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).
The 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).
The investigation also found that you adulterated the new animal drugs neomycin sulfate, sulfadimethoxine oral solution, oxytetracycline injection, oxytetracycline hydrochloride injection, ceftiofur hydrochloride, ceftiofur crystalline free acid, ceftiofur sodium, penicillin G procaine aqueous suspension, florfenicol, tetracycline hydrochloride soluble powder, and tylosin. Specifically, the investigation revealed that you did not use these drugs as directed by their approved labeling. Use of these drugs contrary to their approved labeling is an extralabel use. See 21 C.F.R. 530.3(a).
The extralabel use of approved animal or human drugs in animals is allowed under the Act only if the extralabel 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. 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.
The investigation found that you administered neomycin sulfate to lactating dairy cows contrary to the approved indication of use. Neomycin sulfate is not approved for the treatment and control of Salmonella infections. Your extralabel use of neomycin sulfate was not in compliance with 21 C.F.R. 530, and your extralabel use of neomycin sulfate resulted in an illegal drug residue, in violation of 21 C.F.R. 530.11(d).
The investigation also found that you administered the following new animal drugs contrary to the conditions of use set forth in their approved labeling, and you did so without the supervision of a licensed veterinarian, in violation of 21 C.F.R. 530.11(a):
1. Neomycin sulfate (b)(4) - You administered neomycin sulfate to a lactating dairy cow without following the approved indication of use. Neomycin Sulfate (Neomycin Liquid) is not approved for the treatment and control of Salmonella infections.
2. Sulfadhnethoxine oral solution (b)(4) - You administered sulfadimethoxine oral solution to lactating dairy cows without following the approved route of administration, indications for use, and animal class. Sulfadimethoxine oral solution is not approved for intravenous injection, not approved to treat peritonitis, and not approved for use in lactating dairy cows. Furthermore, sulfonamide drugs, which include sulfadimethoxine, are prohibited for extralabel use in lactating dairy cows by 21 C.F.R. 530.41(a)(9).
3. Oxytetracycline injection (b)(4) - You administered oxytetracycline injection to lactating dairy cows without following the approved dose per injection site. Oxytetracycline injection is not approved for use at more than 10 mL per injection site.
4. Oxytetracycline hydrochloride injection (b)(4) - You administered oxytetracycline hydrochloride injection to lactating dairy cows without following the approved animal class and indications for use. Oxytetracycline hydrochloride injection is not approved for use in lactating dairy cattle, or to treat peritonitis.
5. Ceftiofur hydrochloride (b)(4) - You administered ceftiofur hydrochloride to lactating dairy cows without following the approved indications for use. Ceftiofur hydrochloride is not indicated for treating watery mastitis in cattle, or for post-surgical use.
6. Ceftiofur crystalline free acid (b)(4) - You administered ceftiofur crystalline free acid to lactating dairy cows without following the approved indications of use. Ceftiofur crystalline free acid is not indicated for treating watery mastitis, foot rot, or metritis in cattle, nor is it approved for postsurgical use.
7. Ceftiofur sodium (b)(4) - You administered ceftiofur sodium to lactating dairy cows without following the approved indications for use. Ceftiofur sodium is not indicated for treating watery mastitis or metritis in cattle, nor is it approved for post-surgical use.
8. Penicillin G procaine (b)(4) - You administered penicillin G procaine aqueous suspension to lactating dairy cows without following the approved indications for use, dosage amount, or dosage amount per injection site. Penicillin G procaine aqueous suspension is not indicated for treating mastitis in cattle, not approved at a dose more than 1 mLI100 pounds of body weight, and not approved for use at the rate of more than 10 mL per injection site.
9. Florfenicol (b)(4) - You administered florfenicol to lactating dairy cows without following the approved animal class. Florfenicol is not approved for use in female dairy cattle 20 months of age or older.
10.Tetracycline hydrochloride soluble powder (b)(4) - You administered tetracycline hydrochloride soluble powder to lactating dairy cows without following the approved animal class and indications for use. Tetracycline hydrochloride soluble powder is not approved for treating dairy cows or for treatment of uterine infections.
11. Tylosin (b)(4) - You administered tylosin to dairy calves without following the approved route of administration and indications for use.Tylosin is not approved for oral administration, nor is the drug approved for preventing scours (bacterial enteritis) in dairy calves. Furthermore, the extralabel use of approved new animal or human drugs in or on an animal feed (milk) is prohibited by 21 C.F.R. 530.11(b).
Because your use of these drugs was not in conformance with their approved labeling and did not comply with 21 C.F.R. 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 50 1(a)(5) of the Act, 21 U.S.C. § 351(a)(5).
In addition, you adulterated animal feed (milk) within the meaning of section 501 (a)(6) of the Act, 21 U.S.C. § 351 (a)(6). You administered tylosin to dairy calves to prevent Escherichia coli (E. colI) scours by mixing the drug in milk. This caused the animal feed (milk) to which the drug was added to be unsafe within the meaning of section 512(a)(2) of the Act, 21 U.S.C. § 360b(a)(2), and adulterated under section 501(a)(6) of the Act, 21 U.S.C. § 351(a)(6).
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 are 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 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 to prevent their recurrence. If corrective action cannot be completed within 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 Dr. Brian D. Garthwaite, Compliance Officer, U.S. Food and Drug Administration, at the address located on the letterhead. If you have any questions about this letter, please contact Dr. Garthwaite at (612) 758-7132.
Sincerely,
/s/
W. Charles Becoat Director Minneapolis District
BDG/ccl
(b)(4)
Doug Leuders Minnesota Department of Agriculture 625 North Robert Street St. Paul, Minnesota 55155
District Manager, USDA-FSIS Butler Square West, Suite 989-C 100 North Sixth Street Minneapolis, Minnesota 55403
http://www.fda.gov/ICECI/EnforcementAct ... 186791.htm
“October 2009
It should be noted that humans can become more susceptible to infection with antimicrobial-resistant zoonotic bacteria to which they are exposed. This can happen, when there has been prior use of antimicrobials, resulting in decrease in colonization resistance (dysregulation of intestinal microbiota) and an increased vulnerability to gastrointestinal illness with antimicrobial-resistant food-borne pathogens. This applies to all infections with all micro-organisms listed in this document.
snip...
http://www.efsa.europa.eu/cs/BlobServer ... inary=true
http://www.fda.gov/ICECI/EnforcementAct ... 189754.htm
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.
http://www.fda.gov/ICECI/EnforcementAct ... 189720.htm
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.
http://www.fda.gov/ICECI/EnforcementAct ... 189789.htm
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.
Recently Posted Warning Letters Posted on November 17, 2009
http://www.fda.gov/ICECI/EnforcementAct ... efault.htm
see also my blog on MRSA here ;
http://staphmrsa.blogspot.com/
Friday, January 29, 2010
14th International Congress on Infectious Diseases H-type and L-type Atypical BSE January 2010 (special pre-congress edition)
http://bse-atypical.blogspot.com/2010/0 ... ss-on.html
*** CJD USA RISING, with UNKNOWN PHENOTYPE ;
5 Includes 41 cases in which the diagnosis is pending, and 17 inconclusive cases; 6 Includes 46 cases with type determination pending in which the diagnosis of vCJD has been excluded.
http://www.cjdsurveillance.com/pdf/case-table.pdf
Saturday, January 2, 2010
Human Prion Diseases in the United States January 1, 2010 ***FINAL***
http://prionunitusaupdate2008.blogspot. ... tates.html
my comments to PLosone here ;
http://www.plosone.org/annotation/listT ... 31e2bfa6fd
Thursday, February 4, 2010
SPONGIFORM ENCEPHALOPATHY ADVISORY COMMITTEE Draft Minutes of the 103rd Meeting held on 24th November 2009
http://seac992007.blogspot.com/2010/02/ ... isory.html
Friday, February 05, 2010
New Variant Creutzfelt Jakob Disease case reports United States 2010 A Review
http://vcjd.blogspot.com/2010/02/new-va ... sease.html
Wednesday, February 10, 2010
NAIS MAD COW TRACEABILITY DUMPED BY USDA APHIS 2010
http://naiscoolyes.blogspot.com/2010/02 ... ed-by.html
Terry S. Singeltary Sr.
P.O. Box 42
Bacliff, Texas USA 77518
Thursday, February 11, 2010
Denmark's Case for Antibiotic-Free Animals NEW YORK, Feb. 10, 2010
http://staphmrsa.blogspot.com/2010/02/d ... -free.html
Denmark's Case for Antibiotic-Free Animals
Katie Couric Reports on Denmark's Ban on Antibiotics in Livestock
CBS) They call it the "Danish Experiment" - a source of pride for the country's 17,000 farmers. CBS Evening News Anchor Katie Couric reports how unlike industrial farms in the U.S., which use antibiotics to promote growth and prevent disease, farmers in Denmark use antibiotics sparingly, only when animals are sick.
The experiment to stop widespread use of antibiotics was launched 12 years ago, when European studies showed a link between animals who were consuming antibiotic feed everyday and people developing antibiotic resistant infections from handling or eating that meat.
"We don't want to use more medicine than needed, and a lot of the medicine that is given is not needed," said Soren Helmer. Helmer is a second-generation pig farmer whose sows produce more than 30,000 pigs a year. When the ban started, he and his father thought the industry would suffer.
"We thought we could not produce pigs as efficient as we did before," Helmer said. "But that was proven wrong."
Since the ban, the Danish pork industry has grown by 43 percent - making it one of the top exporters of pork in the world. All of Europe followed suit in 2006. But the American Pork Industry doesn't want to.
"What we've seen in Denmark and other countries is that they actually have had some increases in cost of what it takes to produce a pig," said Liz Wagstrom, a veterinarian with the National Pork Board.
"So it's not that unqualified a success. If we did the same thing in the United States, we would likely see small producers pushed out of business, we'd have more sick and dying pigs, and none of that would result in a benefit to the U.S. consumer."
Without growth-promoting antibiotics, it only costs $5 more for every 100 pounds of pork brought to market in this country.
Animal Antibiotics a Threat?
That's a small price for public health, says Dr. Ellen Silbergeld, who has been studying the antibiotic resistance link between livestock and people for the past decade.
"I think the Danish and European experience indicate that there will be real and measurable public health benefits," she said. "There'll be improvements in food safety and actually in the prevalence of drug resistant infections in people."
Pew Campaign on Human Health and Industrial Farming
According to one study, when different countries introduced certain antibiotics on farms, a surge occurred in people contracting antibiotic resistant intestinal infections one to two years later. One infection, Campylobacter, increased 20 percent in Denmark and 70 percent in Spain.
After the ban, a Danish study confirmed that removing antibiotics from farms drastically reduced antibiotic-resistant bacteria in animals and food.
Danish scientists believe if the U.S. doesn't stop pumping its farm animals with antibiotics, drug-resistant diseases in people will only spread.
"It's not going to be a time bomb that goes off like this," said Dr. Frank Aarestrup, of the Danish Food Institute at the University of Denmark. "It's something that's slowly getting more and more complicated, more difficult for us to actually treat infections.
Rep. Slaughter's "Preservation of Antibiotics for Medical Treatment Act"
Some American food producers agree.
"It's just gone too far," said Stephen McDonnell, CEO Applegate Farms.
"What most bothers you about the way industrial farmers in this country currently operate," Couric asked.
"We use too many antibiotics, we use too many growth promotants," McDonnell replied. "The singular focus is to create cheap meat. That's not always the best thing for the health of the Americans who buy it."
"We think with some subtle changes - giving them more space, feeding them a good diet, and not stressing them out by growing them too quickly - you don't even need to use antibiotics," McDonnell added.
McDonnell helps farmers like Duane Koch kick the habit.
"How long have you been raising turkeys, Duane, without using antibiotics," Couric asked.
"We started running without antibiotics roughly 14 years ago," Koch replied.
"Does it make you feel better doing it this way," Couric asked.
"Yeah," Koch said. "Because really, from using the antibiotics so long, a lot of them didn't work well any way anymore."
Today his 18 poultry farms scattered throughout Pennsylvania are more profitable than when he used antibiotics.
Koch says it costs very little to convert a farm to antibiotic-free. And it doesn't cost consumers much more either. People buying antibiotic free turkey thigh meat will spend around $1.40 versus $1.20 for conventionally raised birds.
Koch says higher-quality feed and improving living conditions, his birds are naturally healthier.
Couric asked, "What's the importance of giving them more space?"
"That's just our natural growth promotants," he said. "By giving them more space, we can get weights that are really close to what they're getting, you know, with the growth promotants."
Because farmers are raising livestock successfully without growth-promoting antibiotics - from Lebanon, Pennsylvania to outside Copenhagen - public health officials in this country say this is an idea whose time has come.
"We have identified here that we're talking about a public health issue, that the overuse of antibiotics on farms does pose a risk to human health," said Joshua Sharfstein of the FDA.
The FDA has for the first time come out against using certain antibiotics to promote growth in livestock.
And pending legislation in Congress would ban some types of antibiotics used to treat humans from being administered to healthy farm animals.
http://www.cbsnews.com/stories/2010/02/ ... 5054.shtml
Hello Ms. Couric Ma'am !
Thank you very much on that show of yours about antibiotics in meat, the over-use-of, and resistance there from, to humans and animals. Nice Job! The public is just oblivious to what is going on with the meat they eat. I thought the Danish study was remarkable, and proves what can be done, if an industry wants to do something. sadly, here in the USA, all the industry cares about is their bottom dollar. I have been most concerned about hormones, antibiotics, TSE aka mad cow disease, and other pathogens in meat for some time. I lost my mother to the Heidenhain Variant of Creutzfeldt Jakob Disease, considering North America is home to c-BSE, h-BSE, and the l-BSE in cattle, who is it to say that it should look exactly like the UK c-BSE ??? THEN, my last neck surgery, I believe my neurosurgeon did use a special bone grinder and a few extra precaustion, due to my Mother having died from hvCJD, and they damn near kill me with MRSA. Looking into to that, I was amazed at the amount of antibiotics and hormones that go into cattle due to the fact they are to sick to slaughter. 8 weeks vancomycin straight to the heart via long pic line made a believer in me. now I know some how I was infected probably via the operating arena, there were 7 other's the same week from the same surgcial unit, I was told later (this was in 2002), but we have become immune to these medicines due to over use, not only in humans but animals for human consumption as well. on most any given tuesday you can find something like this ;
October 9,2009
WARNING LETTER
CERTIFIED MAIL RETURN RECEIPT REQUESTED
Keith L. Schaeffer Owner Evergreen Acres Dairy, LLC 26162 240th Street Paynesville, Minnesota 56362
Dear Mr. Schaeffer:
Refer to MIN 10 - 01
On April 23 and May 4,2009, the Minnesota Department of Agriculture conducted an investigation of your dairy operation located at 26162 240th Street, Paynesville, Minnesota. This letter notifies you of the violations of the Federal Food, Drug, and Cosmetic Act (the Act) that were found during the 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.
The investigation 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, the investigation revealed that on or about September 16, 2008, you sold a dairy cow identified with your farm ear tag #(b)(4)for slaughter as food. On or about September 17, 2008, (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 neomycin at 31.05 parts per million (ppm) in kidney tissue. FDA has established a tolerance of 7.2 ppm neomycin residue in kidney tissue as codified in Title 21, Code of Federal Regulations, Section 556.430(b)(1), 21 C.F.R. 556.430(b)(1). The presence of this drug in kidney 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).
The 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).
The investigation also found that you adulterated the new animal drugs neomycin sulfate, sulfadimethoxine oral solution, oxytetracycline injection, oxytetracycline hydrochloride injection, ceftiofur hydrochloride, ceftiofur crystalline free acid, ceftiofur sodium, penicillin G procaine aqueous suspension, florfenicol, tetracycline hydrochloride soluble powder, and tylosin. Specifically, the investigation revealed that you did not use these drugs as directed by their approved labeling. Use of these drugs contrary to their approved labeling is an extralabel use. See 21 C.F.R. 530.3(a).
The extralabel use of approved animal or human drugs in animals is allowed under the Act only if the extralabel 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. 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.
The investigation found that you administered neomycin sulfate to lactating dairy cows contrary to the approved indication of use. Neomycin sulfate is not approved for the treatment and control of Salmonella infections. Your extralabel use of neomycin sulfate was not in compliance with 21 C.F.R. 530, and your extralabel use of neomycin sulfate resulted in an illegal drug residue, in violation of 21 C.F.R. 530.11(d).
The investigation also found that you administered the following new animal drugs contrary to the conditions of use set forth in their approved labeling, and you did so without the supervision of a licensed veterinarian, in violation of 21 C.F.R. 530.11(a):
1. Neomycin sulfate (b)(4) - You administered neomycin sulfate to a lactating dairy cow without following the approved indication of use. Neomycin Sulfate (Neomycin Liquid) is not approved for the treatment and control of Salmonella infections.
2. Sulfadhnethoxine oral solution (b)(4) - You administered sulfadimethoxine oral solution to lactating dairy cows without following the approved route of administration, indications for use, and animal class. Sulfadimethoxine oral solution is not approved for intravenous injection, not approved to treat peritonitis, and not approved for use in lactating dairy cows. Furthermore, sulfonamide drugs, which include sulfadimethoxine, are prohibited for extralabel use in lactating dairy cows by 21 C.F.R. 530.41(a)(9).
3. Oxytetracycline injection (b)(4) - You administered oxytetracycline injection to lactating dairy cows without following the approved dose per injection site. Oxytetracycline injection is not approved for use at more than 10 mL per injection site.
4. Oxytetracycline hydrochloride injection (b)(4) - You administered oxytetracycline hydrochloride injection to lactating dairy cows without following the approved animal class and indications for use. Oxytetracycline hydrochloride injection is not approved for use in lactating dairy cattle, or to treat peritonitis.
5. Ceftiofur hydrochloride (b)(4) - You administered ceftiofur hydrochloride to lactating dairy cows without following the approved indications for use. Ceftiofur hydrochloride is not indicated for treating watery mastitis in cattle, or for post-surgical use.
6. Ceftiofur crystalline free acid (b)(4) - You administered ceftiofur crystalline free acid to lactating dairy cows without following the approved indications of use. Ceftiofur crystalline free acid is not indicated for treating watery mastitis, foot rot, or metritis in cattle, nor is it approved for postsurgical use.
7. Ceftiofur sodium (b)(4) - You administered ceftiofur sodium to lactating dairy cows without following the approved indications for use. Ceftiofur sodium is not indicated for treating watery mastitis or metritis in cattle, nor is it approved for post-surgical use.
8. Penicillin G procaine (b)(4) - You administered penicillin G procaine aqueous suspension to lactating dairy cows without following the approved indications for use, dosage amount, or dosage amount per injection site. Penicillin G procaine aqueous suspension is not indicated for treating mastitis in cattle, not approved at a dose more than 1 mLI100 pounds of body weight, and not approved for use at the rate of more than 10 mL per injection site.
9. Florfenicol (b)(4) - You administered florfenicol to lactating dairy cows without following the approved animal class. Florfenicol is not approved for use in female dairy cattle 20 months of age or older.
10.Tetracycline hydrochloride soluble powder (b)(4) - You administered tetracycline hydrochloride soluble powder to lactating dairy cows without following the approved animal class and indications for use. Tetracycline hydrochloride soluble powder is not approved for treating dairy cows or for treatment of uterine infections.
11. Tylosin (b)(4) - You administered tylosin to dairy calves without following the approved route of administration and indications for use.Tylosin is not approved for oral administration, nor is the drug approved for preventing scours (bacterial enteritis) in dairy calves. Furthermore, the extralabel use of approved new animal or human drugs in or on an animal feed (milk) is prohibited by 21 C.F.R. 530.11(b).
Because your use of these drugs was not in conformance with their approved labeling and did not comply with 21 C.F.R. 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 50 1(a)(5) of the Act, 21 U.S.C. § 351(a)(5).
In addition, you adulterated animal feed (milk) within the meaning of section 501 (a)(6) of the Act, 21 U.S.C. § 351 (a)(6). You administered tylosin to dairy calves to prevent Escherichia coli (E. colI) scours by mixing the drug in milk. This caused the animal feed (milk) to which the drug was added to be unsafe within the meaning of section 512(a)(2) of the Act, 21 U.S.C. § 360b(a)(2), and adulterated under section 501(a)(6) of the Act, 21 U.S.C. § 351(a)(6).
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 are 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 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 to prevent their recurrence. If corrective action cannot be completed within 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 Dr. Brian D. Garthwaite, Compliance Officer, U.S. Food and Drug Administration, at the address located on the letterhead. If you have any questions about this letter, please contact Dr. Garthwaite at (612) 758-7132.
Sincerely,
/s/
W. Charles Becoat Director Minneapolis District
BDG/ccl
(b)(4)
Doug Leuders Minnesota Department of Agriculture 625 North Robert Street St. Paul, Minnesota 55155
District Manager, USDA-FSIS Butler Square West, Suite 989-C 100 North Sixth Street Minneapolis, Minnesota 55403
http://www.fda.gov/ICECI/EnforcementAct ... 186791.htm
“October 2009
It should be noted that humans can become more susceptible to infection with antimicrobial-resistant zoonotic bacteria to which they are exposed. This can happen, when there has been prior use of antimicrobials, resulting in decrease in colonization resistance (dysregulation of intestinal microbiota) and an increased vulnerability to gastrointestinal illness with antimicrobial-resistant food-borne pathogens. This applies to all infections with all micro-organisms listed in this document.
snip...
http://www.efsa.europa.eu/cs/BlobServer ... inary=true
http://www.fda.gov/ICECI/EnforcementAct ... 189754.htm
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.
http://www.fda.gov/ICECI/EnforcementAct ... 189720.htm
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.
http://www.fda.gov/ICECI/EnforcementAct ... 189789.htm
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.
Recently Posted Warning Letters Posted on November 17, 2009
http://www.fda.gov/ICECI/EnforcementAct ... efault.htm
see also my blog on MRSA here ;
http://staphmrsa.blogspot.com/
Friday, January 29, 2010
14th International Congress on Infectious Diseases H-type and L-type Atypical BSE January 2010 (special pre-congress edition)
http://bse-atypical.blogspot.com/2010/0 ... ss-on.html
*** CJD USA RISING, with UNKNOWN PHENOTYPE ;
5 Includes 41 cases in which the diagnosis is pending, and 17 inconclusive cases; 6 Includes 46 cases with type determination pending in which the diagnosis of vCJD has been excluded.
http://www.cjdsurveillance.com/pdf/case-table.pdf
Saturday, January 2, 2010
Human Prion Diseases in the United States January 1, 2010 ***FINAL***
http://prionunitusaupdate2008.blogspot. ... tates.html
my comments to PLosone here ;
http://www.plosone.org/annotation/listT ... 31e2bfa6fd
Thursday, February 4, 2010
SPONGIFORM ENCEPHALOPATHY ADVISORY COMMITTEE Draft Minutes of the 103rd Meeting held on 24th November 2009
http://seac992007.blogspot.com/2010/02/ ... isory.html
Friday, February 05, 2010
New Variant Creutzfelt Jakob Disease case reports United States 2010 A Review
http://vcjd.blogspot.com/2010/02/new-va ... sease.html
Wednesday, February 10, 2010
NAIS MAD COW TRACEABILITY DUMPED BY USDA APHIS 2010
http://naiscoolyes.blogspot.com/2010/02 ... ed-by.html
Terry S. Singeltary Sr.
P.O. Box 42
Bacliff, Texas USA 77518
Thursday, February 11, 2010
Denmark's Case for Antibiotic-Free Animals NEW YORK, Feb. 10, 2010
http://staphmrsa.blogspot.com/2010/02/d ... -free.html
