Subject: Routine Feeding Of Antibiotics To Livestock May Be Contaminating The Environment
Date: July 13, 2007 at 9:09 am PST
Source: Soil Science Society of America
Date: July 13, 2007
More on: Agriculture and Food, Bacteria, Endangered Plants, Organic, Microbes and More, Soil Types
Routine Feeding Of Antibiotics To Livestock May Be Contaminating The Environment
Science Daily — It is estimated that between 9 and 13 million kilograms of antibiotics are used annually in the United States for raising livestock, with the majority being used for growth advancement and disease prevention purposes. Large amounts of antibiotics fed to livestock are excreted and end up in animal manure, which is commonly applied to agricultural land to provide crop nutrients. Therefore, food crops grown on manure-altered soils are exposed to antibiotics.
Scientists at the University of Minnesota have been evaluating the impact of antibiotic feeding in livestock production on the environment. This particular study, funded by the United States Department of Agriculture (USDA), evaluated whether food crops accumulate antibiotics from soils spread with manure that contains antibiotics.
Plant uptake was evaluated in a greenhouse study involving three food crops: corn, lettuce, and potato. Plants were grown on soil modified with liquid hog manure containing Sulfamethazine, a commonly used veterinary antibiotic. This antibiotic was taken up by all three crops. Concentrations of antibiotics were found in the plant leaves. Concentrations in plant tissue also increased as the amount of antibiotics present in the manure increased. It also diffused into potato tubers, which suggests that root crops, such as potatoes, carrots, and radishes, that directly come in contact with soil may be particularly vulnerable to antibiotic contamination.
The ability of plants to absorb antibiotics raises the potential for contamination of human food supply. However, Satish Gupta, group leader notes "The adverse impacts of consuming plants that contain small quantities of antibiotics are largely unknown". Consumption of antibiotics in plants may cause allergic reactions in sensitive populations, such as young children. There is also concern that consuming antibiotics may lead to the development of antimicrobial resistance, which can render antibiotics ineffective.
Holly Dolliver, the lead scientist in this study, notes that antibiotics consumed by plants may be of particular concern to the organic farming industry. Manure is often the main source of crop nutrients for organic food production, since regulations prohibit the use of synthetic fertilizers. According to the USDA, producers must manage animal materials in a manner that does not contribute to contamination of crops by residues of prohibited substances, which includes antibiotics. However, manures containing antibiotics are not formally banned or prohibited.
Further research is needed to investigate the presence of antibiotics in edible parts of plants, especially vegetables that are consumed raw, and how different plants absorb different antibiotic compounds. Research is ongoing at the University of Minnesota to further investigate the potential fate and transport of antibiotics introduced to the environment from livestock operations.
Results from the study are published in the July-August 2007 issue of the Journal of Environmental Quality. The research was also presented in Indianapolis, IN at the Annual Soil Science Society of America Meeting in November 2006.
Note: This story has been adapted from a news release issued by Soil Science Society of America.
http://www.sciencedaily.com/releases/20 ... 134530.htm
Sulfamethazine Uptake by Plants from Manure-Amended Soil
Holly Dollivera, Kuldip Kumarb and Satish Guptaa,*
a Dep. of Soil, Water, and Climate, Univ. of Minnesota, 1991 Upper Buford Circle, St. Paul, MN 55108
b Res. and Dev., Metropolitan Water Reclamation District of Greater Chicago, 6001 West Pershing Rd., Cicero, IL 60804-4112
* Corresponding author ([email protected])
Received for publication July 5, 2006. Animal manure is applied to agricultural land as a means to provide crop nutrients. However, animal manure often contains antibiotics as a result of extensive therapeutic and subtherapeutic use in livestock production. The objective of this study was to evaluate plant uptake of a sulfonamide-class antibiotic, sulfamethazine, in corn (Zea mays L.), lettuce (Lactuca sativa L.), and potato (Solanum tuberosum L.) grown in a manure-amended soil. The treatments were 0, 50, and 100 µg sulfamethazine mL–1 manure applied at a rate of 56 000 L ha–1. Results from the 45-d greenhouse experiment showed that sulfamethazine was taken up by all three crops, with concentrations in plant tissue ranging from 0.1 to 1.2 mg kg–1 dry weight. Sulfamethazine concentrations in plant tissue increased with corresponding increase of sulfamethazine in manure. Highest plant tissue concentrations were found in corn and lettuce, followed by potato. Total accumulation of sulfamethazine in plant tissue after 45 d of growth was less than 0.1% of the amount applied to soil in manure. These results raise potential human health concerns of consuming low levels of antibiotics from produce grown on manure-amended soils.
http://jeq.scijournals.org/cgi/content/ ... /36/4/1224
Regulatory Activities for April and May 2007
Warning Letters
A WARNING LETTER was issued to Leonard D. Hoekstra, president of Doon Elevator Company, Doon, IA, for significant deviations from the current Good Manufacturing Practice (cGMP) regulations for medicated feeds (21 CFR Part 225). The deviations caused the feeds being manufactured at this facility to be adulterated under Section 501(a) of the Federal Food, Drug, and Cosmetic Act (FFDCA). FDA's investigation revealed the following: medicated feeds had been manufactured containing the combinations of chlortetracycline with carbadox and penicillin with carbadox, and neither of these combinations is approved; the production records are not adequate to facilitate a recall of specific batches of medicated feeds, if necessary; and deliveries of bulk medicated feeds were not adequately labeled to ensure the proper use of the feed (e.g., the labeling accompanying bulk medicated feeds did not contain feeding directions or the indications for use statement).
Residues of the drug, gentamicin, in the kidney tissues of two calves offered for sale as food led to the issuance of a WARNING LETTER to Manuel Carrizales of Hereford, TX. There is no tolerance for residues of this drug in the edible tissues of bovine animals (21CFR 556. 300) and, therefore, the animals were adulterated within the meaning of Section 402(a) of the FFDCA. In addition, Mr. Carrizales was cited for offering for slaughter as food another calf that contained the drug ivermectin in the liver and muscle tissue at concentrations of 0.114 parts per million (ppm) and 0.023 ppm, respectively. By regulation (21 CFR 556.344), the established tolerance for ivermectin in the edible tissue of cattle is 0.1 ppm in the liver and 0.01 ppm in the muscle. As a result, this animal was also deemed adulterated under Section 402(a) of the FFDCA.
Merle W. Young, Jr., owner of the Young View Farm, West Glover, VT, received a WARNING LETTER for offering animals for sale for slaughter as food that were adulterated under Section 402(a) of the FFDCA. Specifically, tissue sampling conducted by the U.S. Department of Agriculture (USDA) revealed the presence of 0.622 ppm of the drug, flunixin, in the liver tissue of one of the slaughtered cows. A tolerance of 0.125 ppm has been established in 21 CFR 556.286 for residues of this drug in the liver tissues of cattle. Tissues taken from a second cow that was offered for slaughter as food revealed the presence of 8.54 ppm of the drug neomycin in the kidney tissue. A tolerance of 7.2 ppm has been established for residues of this drug in kidney tissue of cattle (21 CFR 556.430). Mr. Young was also cited in the WARNING LETTER for using both drugs extralabel in violation of Section 512 of the FFDCA and of 21 CFR 530, in that the use was not by or on the lawful order of a licensed veterinarian within the context of a valid veterinarian/client/patient -relationship.
A WARNING LETTER was issued to David Tucker Purchase, co-owner of Fairmont Dairy LLC of Craftsbury, VT, for marketing two animals for sale as food in violation of the adulteration provisions of Section 402(a) of the FFDCA. The investigation by FDA also revealed that the firm caused the new animal drugs penicillin G procaine and flunixin meglumine injection to be unsafe under Section 512(a) and adulterated within the meaning of section 501(a)(5) of the FFDCA. Specifically, a dairy cow offered for slaughter was found to have 0.22 ppm of penicillin in the kidney tissues. Pursuant to 21 CFR 556.510, a tolerance of 0.05 ppm has been established for residues of this drug in the edible tissues of cattle. A second dairy cow offered for slaughter was found to have 0.234 ppm of flunixin in the liver tissue. Pursuant to 21 CFR 556.286, a tolerance of 0.125 ppm has been established for residues of this drug in the liver of cattle. FDA also determined that the firm administered penicillin G procaine without following the dosage level and duration of treatment for cattle set forth in the approved labeling and it did so without the supervision of a licensed veterinarian, in violation of 21 CFR 530.11(a). In addition, the Fairmont Dairy administered flunixin meglumine without following the route of administration for beef and dairy cattle set forth in the approved labeling and did so without the supervision of a licensed veterinarian, in violation of 21 CFR 530.11(a). Furthermore, the dairy's extralabel use of these drugs resulted in illegal drug residues, in violation of 21 CFR 530.11(d). Because the extralabel use of these drugs was not in compliance with 21 CFR Part 530, the drugs were unsafe under Section 512(a) and were adulterated within the meaning of section 501(a)(5) of the FFDCA.
Similar violations were cited in a WARNING LETTER issued to Leonard M. Giglio, owner of Rockland Farm of Bolton, CT, for marketing a dairy cow for slaughter that was adulterated under section 402(a) of the FFDCA. Samples from the animal revealed the presence of residues of the new animal drug, gentamicin sulfate, in the kidney tissue. No tolerance has been established for residues of this drug in the uncooked edible tissues of cattle. The farm was also cited for lacking adequate recordkeeping systems and for not using gentamicin sulfate by or on the order of a licensed veterinarian within the context of a valid veterinarian/client/patient relationship. This violated Section 512(a) of the FFDCA and also 21 CFR 530.
Ferdinand M. Ritsema, owner of the Lakin Dairy of Lakin, KS, received a WARNING LETTER from FDA for violations of the safety and adulteration provisions of Sections 512 and 501(a), respectively, of the FFDCA. Specifically, Mr. Ritsema was cited for extralabel use of penicillin and sulfadimethoxine without following the parameters set forth in the Act. Penicillin was administered without following the dosage level, duration of treatment, and withdrawal period set forth in the approved labeling and without the supervision of a licensed veterinarian, in violation of 21 CFR 530.11(a). In addition, Mr. Ritsema administered Albon (sulfadimethoxine) to a dairy cow for a longer period of time than listed on the drug label. This cow was offered for sale for slaughter for human food. The prescription label the firm's veterinarian affixed to the penicillin that was used listed a 10- to 14-day withdrawal time, but Albon is labeled for treatment for 5 days with a 7-day withdrawal time. Company records indicated that the animal was withheld from slaughter for 1 day after stopping treatment with Albon and penicillin. Albon is prohibited from extralabel use in lactating dairy cattle under 21 CFR 530.41(9). In addition, a number of expired new animal drugs were observed by FDA investigators in the firm's storage room.
Violations of Sections 402(a), 512, and 501(a) of the FFDCA have been cited in a WARNING LETTER that FDA issued to the three co-owners of the Thiele Dairy in Clearwater, NE. Specifically, tissue samples collected from a dairy cow that was offered for slaughter revealed the presence of gentamicin in the kidney tissues, but no tolerance for this drug in the kidney tissues of cattle has been established in 21 CFR 556.300. Therefore, the animal was adulterated pursuant to Section 402(a) of the FFDCA. Adequate treatment records and drug inventory system were also found to be lacking. FDA investigators also found that the firm was using gentamicin extralabel without complying with Section 512(a) of the FFDCA. For example, the dairy administered gentamicin without following the veterinarian's written instructions for type of animal and for withdrawal time, and this was done without consulting the veterinarian, i.e., without the supervision of a licensed veterinarian, in violation of 21 CFR 530.11(a). Furthermore, the dairy's extralabel use resulted in an illegal drug residue, in violation of 21 CFR 530.11(c).
A WARNING LETTER was issued to Steve T. Kemp, owner of Kemp Cattle of Fort Worth, TX, for violation of Section 402(a) of the FFDCA. Specifically, the firm offered for slaughter as food a total of four calves that were found to be adulterated due to the presence of certain drugs. Tissue sampling by USDA revealed the presence in one calf of the drug penicillin at 0.45 ppm in the liver tissue and 0.11 ppm in the kidney. A tolerance of 0.05 ppm has been established in 21 CFR 556.510 for residues of this drug in the uncooked, edible tissues of cattle. Tissues samples taken from the other three calves revealed the presence of residues of the drug gentamicin in the liver and kidney of two and in the kidney of the third. There is no tolerance established for residues of this drug in the edible tissues of cattle.
Similar violations were cited in a WARNING LETTER issued to Leonard McDaniel, owner, doing business as L & M Cattle Co., of Dallas, TX. Specifically, Mr. McDaniel offered for slaughter as food three calves that were adulterated under Section 402(a) of the FFDCA because two of them contained residues of the drug gentamicin in the liver and kidney and the third calf contained gentamicin residues in the kidney tissue. As stated earlier, there is no tolerance established for residues of this drug in the edible tissues of bovine animals.
Gentamicin is also the subject of a WARNING LETTER issued to James R. Correa, D.V.M., owner of Bear Creek Veterinary Services of Merced, CA. Specifically, a USDA inspection of a dairy cow and an investigation by FDA revealed that the cow in question was raised at a farm but had been medicated; the farm used the veterinary services of Bear Creek Veterinary Services. The WARNING LETTER noted that the drug gentamicin had been prescribed extralabel for use to treat bacterial scours and septicemia in cattle, but gentamicin is not approved for this use in cattle. In addition, Dr. Correa prescribed penicillin G procaine for use at a dose exceeding the approved dosage of 1 cc per 100 lbs. The FDA investigation revealed that Dr. Correa failed to comply with Section 512(a) of the FFDCA and 21 CFR Part 530 by failing to do the following: make a careful diagnosis and evaluation of the conditions for which the drug is to be used; establish a substantially extended withdrawal period prior to marketing of milk, meat, eggs, or other edible products supported by appropriate scientific information; institute procedures to ensure that the identity of the treated animal(s) was carefully maintained; take appropriate measures to ensure that no illegal drug residues occurred in any food-producing animals subjected to the extra-label treatment; comply with the labeling requirements in 21 CFR 530.12(c) by not providing the route of administration for the drug and failing to correctly identify the animals to be treated; and establish a valid veterinarian-client-patient relationship, as set out in 21 CFR 530.3(i).
A WARNING LETTER was issued to Joe A. Sozinho and Kristy Heldman, partners of Clearview Dairy, LLC, in Jerome, ID, for offering for slaughter as food an animal that was adulterated pursuant to Section 402(a) of the FFDCA. Specifically, a USDA inspection of the slaughtered dairy cow revealed the presence of 17.91 ppm of sulfamethazine in the liver tissue and 21.22 ppm of the drug in the muscle tissue. A tolerance of 0.10 ppm has been established for negligible residues of sulfamethazine in the uncooked edible tissues of cattle, as codified in 21 CFR 556.670. In addition, the firm adulterated the new animal drug sulfadimethoxine (Albon) within the meaning of section 501(a)(5) of the Act when it failed to use the drug in conformance with its approved labeling; the drug was used extralabel but not by or on the lawful order of a licensed veterinarian within the context of a valid veterinarian/client/patient relationship as required by the FFDCA and by 21 CFR Part 530.
Daniel S. VanGrouw, owner of Dan VanGrouw Dairy, Meridian, ID, received a WARNING LETTER for offering for slaughter for food a dairy cow that was adulterated under Section 402(a) of the FFDCA. Specifically, USDA's inspection of the animal's tissues revealed the presence of sulfadimethoxine at 5.69 ppm in the muscle. A tolerance of 0.1 ppm has been established for residues of this drug in the edible tissues of cattle as codified in 21 CFR 556.640. FDA's investigation also found that the dairy held animals under conditions that are so inadequate that medicated animals bearing potentially harmful drug residues are likely to enter the food supply. The firm lacked an -adequate system to ensure that medicated animals have been withheld from slaughter for appropriate periods of time to permit depletion of potentially hazardous residues of drugs from edible tissues, which was also a violation of Section 402(a) of the FFDCA.
CVM Reminds Veterinarians to Correctly Use Flunixin Meglumine
The Center for Veterinary Medicine has investigated several cases of violative residue levels of flunixin meglumine in meat, and in May 2007 it issued a reminder to veterinarians about the proper use of the drug and the requirements veterinarians must meet to use the product in an extralabel manner.
CVM had received reports that flunixin meglumine was being prescribed and/or administered to cattle by an intramuscular route. However, the approved route of administration in cattle is restricted to intravenous administration. Using the drug intramuscularly is an extralabel use of the drug.
Flunixin Meglumine Injection is approved for use in cattle for the control of pyrexia associated with bovine respiratory disease and endotoxemia. It is also indicated for the control of inflammation in endotoxemia.
Intramuscular administration of flunixin meglumine can cause violative drug residues, because the drug takes longer to deplete with this route of administration than with intravenous injections.
Under certain conditions, extralabel drug use is permitted under the Animal Medicinal Drug Use Clarification Act of 1994, which modified the Federal, Food, Drug, and Cosmetic Act.
Under the law, veterinarians are permitted to use drugs in an extra-label manner, meaning in ways not approved and specified on the label. But the veterinarian must meet certain requirements, including establishing a substantially long withdrawal period, supported by scientific evidence, so that any food from the animal will not contain violative drug residues. (A withdrawal period is the time between when an animal is administered a drug and when food products—meat, milk, eggs, or other edible products—can safely be obtained from the animal.)
Approved uses of drugs have specified withdrawal times. When drugs are used in an extralabel manner, the veterinarian takes on the responsibility of making sure the withdrawal period is adequate to prevent any violative residues in food products.
A veterinarian cannot legally prescribe the use of a drug in an extralabel fashion unless the use is required to avoid animal suffering or death. CVM has discovered, though, that veterinarians have been prescribing the use of flunixin meglumine intramuscularly simply for convenience. Under the law, that reason is not sufficient to permit extralabel use.
FDA Letter Reminds Feed Manufacturers of Their Obligations
by Walt D. Osborne, M.S., J.D., Assistant Editor
The extensive recall of pet foods that began in March 2007 due to contamination with melamine and its analogs led to the issuance of a letter in May 2007 from CVM Director, Dr. -Stephen Sundlof, to feed and feed ingredient manufacturers reminding them of their legal responsibilities.
Specifically, every ingredient used in an animal feed or feed ingredient must be safe for its intended use, whether the product is meant to be used to feed animals intended for human consumption or to feed non-food animals, such as pets. In the letter, manufacturers were encouraged to make sure they have procedures in place that ensure the safety of the products and ingredients in their products, as well as the safety of the packaging and processing supplies they use. In addition, manufacturers should also verify that their suppliers have such procedures in place. Guidance on these requirements is available at http://www.cfsan.fda.gov/~dms/alert.html.
As the letter noted, manufacturers are responsible for taking their own measures to ensure the safety of their marketed products. They should not wait for possible FDA testing of their materials before pursuing the necessary steps to achieve a high level of safety.
Screening procedure
Companies that are interested in performing their own tests for melamine and its analogs can refer to FDA's Web site at http://www.fda.gov/cvm/-GCMSMelamine.htm. The methodology used by the Food Emergency Response Network laboratories can be found there. As indicated at the link, this version (2.1, dated May 16, 2007) of the gas chromatography (GC) and mass spectrometry (MS) method for the presence of melamine, ammeline, ammelide, and cyanuric acid should be regarded as interim. This procedure was developed to screen various matrices for the presence of melamine and some related compounds at the established minimum reporting level of 10 micrograms per gram and above, using GC/MS. Samples are extracted using a mixture of acetonitrile/water/diethylamine, and the analytes are subsequently converted to trimethylsilyl derivatives for analysis.
Surveillance
As part of a protein ingredient surveillance assignment FDA issued on May 1, 2007, FDA, in conjunction with State regulatory authorities, has been performing inspections of various food and feed facilities. A variety of protein ingredients commonly used in food and feed manufacturing have been sampled and tested for the presence of melamine and melamine-related compounds, all of which are known as triazines. Protein concentrates such as wheat gluten, corn gluten, corn meal, soy protein, and rice protein concentrate imported from China or transshipped from China will be tested. During these inspections, FDA will point out the importance of ensuring the safety and security of the manufacturers' ingredients and products by knowing their manufacturing and packaging operators, ingredient suppliers, contract manufacturers, and sources for all incoming materials.
U.S. Ingredient Supplier Used Melamine
In a development unrelated to the pet food recall, a feed ingredient supplier that sells binding agents used to make pelleted feed products told the Food and
Drug Administration in May that the company had been using melamine, but has since stopped.
FDA reported on May 30 that Tembec BTLSR Inc., Toledo, OH, said it was using melamine to make two aquaculture products, AquaBond and Aqua-Tec II, which Tembec distributed for a second company, Uniscope, Inc., Johnstown, CO.
Uniscope also made a pellet binding ingredient, Xtra-Bond, using ingredients from Tempec that contained melamine.
FDA has advised feed manufacturers to recall finished feed made with AquaBond or Aqua-Tec II, due to the estimated levels of melamine and related compounds in the finished products.
Initial information has led FDA to believe that a recall is not needed for finished feed made with Xtra-Bond, because of the estimated low melamine level in the finished feed. However, as more information is obtained, there may be specific products or circumstances that could require a recall.
Food derived from animals fed these products is unlikely to pose a human health risk, FDA concluded, based on the interim risk assessment FDA and the U.S. Department of Agriculture conducted earlier in May.
International Activities
Chinese Food Safety, Trade Representatives at CVM
On June 19 CVM hosted the training of 14 food safety and trade specialists from China as part of a 7-week program sponsored by the Joint Institute for Food Safety and Applied Nutrition (JIFSAN). This program is one of several efforts by the U.S. Government to train developing countries in sanitary and phytosanitary requirements as members of the World Trade Organization. The day-long series of presentations by CVM technical experts covered veterinary drug approval procedures and review criteria and food and feed safety controls. Here, the Chinese visitors are listening to a presentation about regulations designed to prevent the spread of bovine spongiform encephalopathy.
The presentations at CVM were also attended by representatives of the U.S. Department of Agriculture's Food Safety and Inspection Service and the National Pork Producers Council.
http://www.fda.gov/cvm/FDAVet2007VolXXIINo2.htm#7042
blind leading the blind. ...tss
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/picren ... obtype=pdf
10,000,000+ LBS. of PROHIBITED BANNED MAD COW FEED I.E. MBM IN COMMERCE USA 2007
Date: March 21, 2007 at 2:27 pm PST
RECALLS AND FIELD CORRECTIONS: VETERINARY MEDICINES -- CLASS II
___________________________________
PRODUCT
Bulk cattle feed made with recalled Darling's 85% Blood Meal, Flash Dried, Recall # V-024-2007
CODE
Cattle feed delivered between 01/12/2007 and 01/26/2007
RECALLING FIRM/MANUFACTURER
Pfeiffer, Arno, Inc, Greenbush, WI. by conversation on February 5, 2007. Firm initiated recall is ongoing.
REASON
Blood meal used to make cattle feed was recalled because it was cross-contaminated with prohibited bovine meat and bone meal that had been manufactured on common equipment and labeling did not bear cautionary BSE statement.
VOLUME OF PRODUCT IN COMMERCE
42,090 lbs.
DISTRIBUTION
WI
___________________________________
PRODUCT
Custom dairy premix products: MNM ALL PURPOSE Pellet, HILLSIDE/CDL Prot-Buffer Meal, LEE, M.-CLOSE UP PX Pellet, HIGH DESERT/ GHC LACT Meal, TATARKA, M CUST PROT Meal, SUNRIDGE/CDL PROTEIN Blend, LOURENZO, K PVM DAIRY Meal, DOUBLE B DAIRY/GHC LAC Mineral, WEST PIONT/GHC CLOSEUP Mineral, WEST POINT/GHC LACT Meal, JENKS, J/COMPASS PROTEIN Meal, COPPINI – 8# SPECIAL DAIRY Mix, GULICK, L-LACT Meal (Bulk), TRIPLE J – PROTEIN/LACTATION, ROCK CREEK/GHC MILK Mineral, BETTENCOURT/GHC S.SIDE MK-MN, BETTENCOURT #1/GHC MILK MINR, V&C DAIRY/GHC LACT Meal, VEENSTRA, F/GHC LACT Meal, SMUTNY, A-BYPASS ML W/SMARTA, Recall # V-025-2007
CODE
The firm does not utilize a code - only shipping documentation with commodity and weights identified.
RECALLING FIRM/MANUFACTURER
Rangen, Inc, Buhl, ID, by letters on February 13 and 14, 2007. Firm initiated recall is complete.
REASON
Products manufactured from bulk feed containing blood meal that was cross contaminated with prohibited meat and bone meal and the labeling did not bear cautionary BSE statement.
VOLUME OF PRODUCT IN COMMERCE
9,997,976 lbs.
DISTRIBUTION
ID and NV
END OF ENFORCEMENT REPORT FOR MARCH 21, 2007
http://www.fda.gov/bbs/topics/enforce/2 ... 00996.html
TSS
Date: July 13, 2007 at 9:09 am PST
Source: Soil Science Society of America
Date: July 13, 2007
More on: Agriculture and Food, Bacteria, Endangered Plants, Organic, Microbes and More, Soil Types
Routine Feeding Of Antibiotics To Livestock May Be Contaminating The Environment
Science Daily — It is estimated that between 9 and 13 million kilograms of antibiotics are used annually in the United States for raising livestock, with the majority being used for growth advancement and disease prevention purposes. Large amounts of antibiotics fed to livestock are excreted and end up in animal manure, which is commonly applied to agricultural land to provide crop nutrients. Therefore, food crops grown on manure-altered soils are exposed to antibiotics.
Scientists at the University of Minnesota have been evaluating the impact of antibiotic feeding in livestock production on the environment. This particular study, funded by the United States Department of Agriculture (USDA), evaluated whether food crops accumulate antibiotics from soils spread with manure that contains antibiotics.
Plant uptake was evaluated in a greenhouse study involving three food crops: corn, lettuce, and potato. Plants were grown on soil modified with liquid hog manure containing Sulfamethazine, a commonly used veterinary antibiotic. This antibiotic was taken up by all three crops. Concentrations of antibiotics were found in the plant leaves. Concentrations in plant tissue also increased as the amount of antibiotics present in the manure increased. It also diffused into potato tubers, which suggests that root crops, such as potatoes, carrots, and radishes, that directly come in contact with soil may be particularly vulnerable to antibiotic contamination.
The ability of plants to absorb antibiotics raises the potential for contamination of human food supply. However, Satish Gupta, group leader notes "The adverse impacts of consuming plants that contain small quantities of antibiotics are largely unknown". Consumption of antibiotics in plants may cause allergic reactions in sensitive populations, such as young children. There is also concern that consuming antibiotics may lead to the development of antimicrobial resistance, which can render antibiotics ineffective.
Holly Dolliver, the lead scientist in this study, notes that antibiotics consumed by plants may be of particular concern to the organic farming industry. Manure is often the main source of crop nutrients for organic food production, since regulations prohibit the use of synthetic fertilizers. According to the USDA, producers must manage animal materials in a manner that does not contribute to contamination of crops by residues of prohibited substances, which includes antibiotics. However, manures containing antibiotics are not formally banned or prohibited.
Further research is needed to investigate the presence of antibiotics in edible parts of plants, especially vegetables that are consumed raw, and how different plants absorb different antibiotic compounds. Research is ongoing at the University of Minnesota to further investigate the potential fate and transport of antibiotics introduced to the environment from livestock operations.
Results from the study are published in the July-August 2007 issue of the Journal of Environmental Quality. The research was also presented in Indianapolis, IN at the Annual Soil Science Society of America Meeting in November 2006.
Note: This story has been adapted from a news release issued by Soil Science Society of America.
http://www.sciencedaily.com/releases/20 ... 134530.htm
Sulfamethazine Uptake by Plants from Manure-Amended Soil
Holly Dollivera, Kuldip Kumarb and Satish Guptaa,*
a Dep. of Soil, Water, and Climate, Univ. of Minnesota, 1991 Upper Buford Circle, St. Paul, MN 55108
b Res. and Dev., Metropolitan Water Reclamation District of Greater Chicago, 6001 West Pershing Rd., Cicero, IL 60804-4112
* Corresponding author ([email protected])
Received for publication July 5, 2006. Animal manure is applied to agricultural land as a means to provide crop nutrients. However, animal manure often contains antibiotics as a result of extensive therapeutic and subtherapeutic use in livestock production. The objective of this study was to evaluate plant uptake of a sulfonamide-class antibiotic, sulfamethazine, in corn (Zea mays L.), lettuce (Lactuca sativa L.), and potato (Solanum tuberosum L.) grown in a manure-amended soil. The treatments were 0, 50, and 100 µg sulfamethazine mL–1 manure applied at a rate of 56 000 L ha–1. Results from the 45-d greenhouse experiment showed that sulfamethazine was taken up by all three crops, with concentrations in plant tissue ranging from 0.1 to 1.2 mg kg–1 dry weight. Sulfamethazine concentrations in plant tissue increased with corresponding increase of sulfamethazine in manure. Highest plant tissue concentrations were found in corn and lettuce, followed by potato. Total accumulation of sulfamethazine in plant tissue after 45 d of growth was less than 0.1% of the amount applied to soil in manure. These results raise potential human health concerns of consuming low levels of antibiotics from produce grown on manure-amended soils.
http://jeq.scijournals.org/cgi/content/ ... /36/4/1224
Regulatory Activities for April and May 2007
Warning Letters
A WARNING LETTER was issued to Leonard D. Hoekstra, president of Doon Elevator Company, Doon, IA, for significant deviations from the current Good Manufacturing Practice (cGMP) regulations for medicated feeds (21 CFR Part 225). The deviations caused the feeds being manufactured at this facility to be adulterated under Section 501(a) of the Federal Food, Drug, and Cosmetic Act (FFDCA). FDA's investigation revealed the following: medicated feeds had been manufactured containing the combinations of chlortetracycline with carbadox and penicillin with carbadox, and neither of these combinations is approved; the production records are not adequate to facilitate a recall of specific batches of medicated feeds, if necessary; and deliveries of bulk medicated feeds were not adequately labeled to ensure the proper use of the feed (e.g., the labeling accompanying bulk medicated feeds did not contain feeding directions or the indications for use statement).
Residues of the drug, gentamicin, in the kidney tissues of two calves offered for sale as food led to the issuance of a WARNING LETTER to Manuel Carrizales of Hereford, TX. There is no tolerance for residues of this drug in the edible tissues of bovine animals (21CFR 556. 300) and, therefore, the animals were adulterated within the meaning of Section 402(a) of the FFDCA. In addition, Mr. Carrizales was cited for offering for slaughter as food another calf that contained the drug ivermectin in the liver and muscle tissue at concentrations of 0.114 parts per million (ppm) and 0.023 ppm, respectively. By regulation (21 CFR 556.344), the established tolerance for ivermectin in the edible tissue of cattle is 0.1 ppm in the liver and 0.01 ppm in the muscle. As a result, this animal was also deemed adulterated under Section 402(a) of the FFDCA.
Merle W. Young, Jr., owner of the Young View Farm, West Glover, VT, received a WARNING LETTER for offering animals for sale for slaughter as food that were adulterated under Section 402(a) of the FFDCA. Specifically, tissue sampling conducted by the U.S. Department of Agriculture (USDA) revealed the presence of 0.622 ppm of the drug, flunixin, in the liver tissue of one of the slaughtered cows. A tolerance of 0.125 ppm has been established in 21 CFR 556.286 for residues of this drug in the liver tissues of cattle. Tissues taken from a second cow that was offered for slaughter as food revealed the presence of 8.54 ppm of the drug neomycin in the kidney tissue. A tolerance of 7.2 ppm has been established for residues of this drug in kidney tissue of cattle (21 CFR 556.430). Mr. Young was also cited in the WARNING LETTER for using both drugs extralabel in violation of Section 512 of the FFDCA and of 21 CFR 530, in that the use was not by or on the lawful order of a licensed veterinarian within the context of a valid veterinarian/client/patient -relationship.
A WARNING LETTER was issued to David Tucker Purchase, co-owner of Fairmont Dairy LLC of Craftsbury, VT, for marketing two animals for sale as food in violation of the adulteration provisions of Section 402(a) of the FFDCA. The investigation by FDA also revealed that the firm caused the new animal drugs penicillin G procaine and flunixin meglumine injection to be unsafe under Section 512(a) and adulterated within the meaning of section 501(a)(5) of the FFDCA. Specifically, a dairy cow offered for slaughter was found to have 0.22 ppm of penicillin in the kidney tissues. Pursuant to 21 CFR 556.510, a tolerance of 0.05 ppm has been established for residues of this drug in the edible tissues of cattle. A second dairy cow offered for slaughter was found to have 0.234 ppm of flunixin in the liver tissue. Pursuant to 21 CFR 556.286, a tolerance of 0.125 ppm has been established for residues of this drug in the liver of cattle. FDA also determined that the firm administered penicillin G procaine without following the dosage level and duration of treatment for cattle set forth in the approved labeling and it did so without the supervision of a licensed veterinarian, in violation of 21 CFR 530.11(a). In addition, the Fairmont Dairy administered flunixin meglumine without following the route of administration for beef and dairy cattle set forth in the approved labeling and did so without the supervision of a licensed veterinarian, in violation of 21 CFR 530.11(a). Furthermore, the dairy's extralabel use of these drugs resulted in illegal drug residues, in violation of 21 CFR 530.11(d). Because the extralabel use of these drugs was not in compliance with 21 CFR Part 530, the drugs were unsafe under Section 512(a) and were adulterated within the meaning of section 501(a)(5) of the FFDCA.
Similar violations were cited in a WARNING LETTER issued to Leonard M. Giglio, owner of Rockland Farm of Bolton, CT, for marketing a dairy cow for slaughter that was adulterated under section 402(a) of the FFDCA. Samples from the animal revealed the presence of residues of the new animal drug, gentamicin sulfate, in the kidney tissue. No tolerance has been established for residues of this drug in the uncooked edible tissues of cattle. The farm was also cited for lacking adequate recordkeeping systems and for not using gentamicin sulfate by or on the order of a licensed veterinarian within the context of a valid veterinarian/client/patient relationship. This violated Section 512(a) of the FFDCA and also 21 CFR 530.
Ferdinand M. Ritsema, owner of the Lakin Dairy of Lakin, KS, received a WARNING LETTER from FDA for violations of the safety and adulteration provisions of Sections 512 and 501(a), respectively, of the FFDCA. Specifically, Mr. Ritsema was cited for extralabel use of penicillin and sulfadimethoxine without following the parameters set forth in the Act. Penicillin was administered without following the dosage level, duration of treatment, and withdrawal period set forth in the approved labeling and without the supervision of a licensed veterinarian, in violation of 21 CFR 530.11(a). In addition, Mr. Ritsema administered Albon (sulfadimethoxine) to a dairy cow for a longer period of time than listed on the drug label. This cow was offered for sale for slaughter for human food. The prescription label the firm's veterinarian affixed to the penicillin that was used listed a 10- to 14-day withdrawal time, but Albon is labeled for treatment for 5 days with a 7-day withdrawal time. Company records indicated that the animal was withheld from slaughter for 1 day after stopping treatment with Albon and penicillin. Albon is prohibited from extralabel use in lactating dairy cattle under 21 CFR 530.41(9). In addition, a number of expired new animal drugs were observed by FDA investigators in the firm's storage room.
Violations of Sections 402(a), 512, and 501(a) of the FFDCA have been cited in a WARNING LETTER that FDA issued to the three co-owners of the Thiele Dairy in Clearwater, NE. Specifically, tissue samples collected from a dairy cow that was offered for slaughter revealed the presence of gentamicin in the kidney tissues, but no tolerance for this drug in the kidney tissues of cattle has been established in 21 CFR 556.300. Therefore, the animal was adulterated pursuant to Section 402(a) of the FFDCA. Adequate treatment records and drug inventory system were also found to be lacking. FDA investigators also found that the firm was using gentamicin extralabel without complying with Section 512(a) of the FFDCA. For example, the dairy administered gentamicin without following the veterinarian's written instructions for type of animal and for withdrawal time, and this was done without consulting the veterinarian, i.e., without the supervision of a licensed veterinarian, in violation of 21 CFR 530.11(a). Furthermore, the dairy's extralabel use resulted in an illegal drug residue, in violation of 21 CFR 530.11(c).
A WARNING LETTER was issued to Steve T. Kemp, owner of Kemp Cattle of Fort Worth, TX, for violation of Section 402(a) of the FFDCA. Specifically, the firm offered for slaughter as food a total of four calves that were found to be adulterated due to the presence of certain drugs. Tissue sampling by USDA revealed the presence in one calf of the drug penicillin at 0.45 ppm in the liver tissue and 0.11 ppm in the kidney. A tolerance of 0.05 ppm has been established in 21 CFR 556.510 for residues of this drug in the uncooked, edible tissues of cattle. Tissues samples taken from the other three calves revealed the presence of residues of the drug gentamicin in the liver and kidney of two and in the kidney of the third. There is no tolerance established for residues of this drug in the edible tissues of cattle.
Similar violations were cited in a WARNING LETTER issued to Leonard McDaniel, owner, doing business as L & M Cattle Co., of Dallas, TX. Specifically, Mr. McDaniel offered for slaughter as food three calves that were adulterated under Section 402(a) of the FFDCA because two of them contained residues of the drug gentamicin in the liver and kidney and the third calf contained gentamicin residues in the kidney tissue. As stated earlier, there is no tolerance established for residues of this drug in the edible tissues of bovine animals.
Gentamicin is also the subject of a WARNING LETTER issued to James R. Correa, D.V.M., owner of Bear Creek Veterinary Services of Merced, CA. Specifically, a USDA inspection of a dairy cow and an investigation by FDA revealed that the cow in question was raised at a farm but had been medicated; the farm used the veterinary services of Bear Creek Veterinary Services. The WARNING LETTER noted that the drug gentamicin had been prescribed extralabel for use to treat bacterial scours and septicemia in cattle, but gentamicin is not approved for this use in cattle. In addition, Dr. Correa prescribed penicillin G procaine for use at a dose exceeding the approved dosage of 1 cc per 100 lbs. The FDA investigation revealed that Dr. Correa failed to comply with Section 512(a) of the FFDCA and 21 CFR Part 530 by failing to do the following: make a careful diagnosis and evaluation of the conditions for which the drug is to be used; establish a substantially extended withdrawal period prior to marketing of milk, meat, eggs, or other edible products supported by appropriate scientific information; institute procedures to ensure that the identity of the treated animal(s) was carefully maintained; take appropriate measures to ensure that no illegal drug residues occurred in any food-producing animals subjected to the extra-label treatment; comply with the labeling requirements in 21 CFR 530.12(c) by not providing the route of administration for the drug and failing to correctly identify the animals to be treated; and establish a valid veterinarian-client-patient relationship, as set out in 21 CFR 530.3(i).
A WARNING LETTER was issued to Joe A. Sozinho and Kristy Heldman, partners of Clearview Dairy, LLC, in Jerome, ID, for offering for slaughter as food an animal that was adulterated pursuant to Section 402(a) of the FFDCA. Specifically, a USDA inspection of the slaughtered dairy cow revealed the presence of 17.91 ppm of sulfamethazine in the liver tissue and 21.22 ppm of the drug in the muscle tissue. A tolerance of 0.10 ppm has been established for negligible residues of sulfamethazine in the uncooked edible tissues of cattle, as codified in 21 CFR 556.670. In addition, the firm adulterated the new animal drug sulfadimethoxine (Albon) within the meaning of section 501(a)(5) of the Act when it failed to use the drug in conformance with its approved labeling; the drug was used extralabel but not by or on the lawful order of a licensed veterinarian within the context of a valid veterinarian/client/patient relationship as required by the FFDCA and by 21 CFR Part 530.
Daniel S. VanGrouw, owner of Dan VanGrouw Dairy, Meridian, ID, received a WARNING LETTER for offering for slaughter for food a dairy cow that was adulterated under Section 402(a) of the FFDCA. Specifically, USDA's inspection of the animal's tissues revealed the presence of sulfadimethoxine at 5.69 ppm in the muscle. A tolerance of 0.1 ppm has been established for residues of this drug in the edible tissues of cattle as codified in 21 CFR 556.640. FDA's investigation also found that the dairy held animals under conditions that are so inadequate that medicated animals bearing potentially harmful drug residues are likely to enter the food supply. The firm lacked an -adequate system to ensure that medicated animals have been withheld from slaughter for appropriate periods of time to permit depletion of potentially hazardous residues of drugs from edible tissues, which was also a violation of Section 402(a) of the FFDCA.
CVM Reminds Veterinarians to Correctly Use Flunixin Meglumine
The Center for Veterinary Medicine has investigated several cases of violative residue levels of flunixin meglumine in meat, and in May 2007 it issued a reminder to veterinarians about the proper use of the drug and the requirements veterinarians must meet to use the product in an extralabel manner.
CVM had received reports that flunixin meglumine was being prescribed and/or administered to cattle by an intramuscular route. However, the approved route of administration in cattle is restricted to intravenous administration. Using the drug intramuscularly is an extralabel use of the drug.
Flunixin Meglumine Injection is approved for use in cattle for the control of pyrexia associated with bovine respiratory disease and endotoxemia. It is also indicated for the control of inflammation in endotoxemia.
Intramuscular administration of flunixin meglumine can cause violative drug residues, because the drug takes longer to deplete with this route of administration than with intravenous injections.
Under certain conditions, extralabel drug use is permitted under the Animal Medicinal Drug Use Clarification Act of 1994, which modified the Federal, Food, Drug, and Cosmetic Act.
Under the law, veterinarians are permitted to use drugs in an extra-label manner, meaning in ways not approved and specified on the label. But the veterinarian must meet certain requirements, including establishing a substantially long withdrawal period, supported by scientific evidence, so that any food from the animal will not contain violative drug residues. (A withdrawal period is the time between when an animal is administered a drug and when food products—meat, milk, eggs, or other edible products—can safely be obtained from the animal.)
Approved uses of drugs have specified withdrawal times. When drugs are used in an extralabel manner, the veterinarian takes on the responsibility of making sure the withdrawal period is adequate to prevent any violative residues in food products.
A veterinarian cannot legally prescribe the use of a drug in an extralabel fashion unless the use is required to avoid animal suffering or death. CVM has discovered, though, that veterinarians have been prescribing the use of flunixin meglumine intramuscularly simply for convenience. Under the law, that reason is not sufficient to permit extralabel use.
FDA Letter Reminds Feed Manufacturers of Their Obligations
by Walt D. Osborne, M.S., J.D., Assistant Editor
The extensive recall of pet foods that began in March 2007 due to contamination with melamine and its analogs led to the issuance of a letter in May 2007 from CVM Director, Dr. -Stephen Sundlof, to feed and feed ingredient manufacturers reminding them of their legal responsibilities.
Specifically, every ingredient used in an animal feed or feed ingredient must be safe for its intended use, whether the product is meant to be used to feed animals intended for human consumption or to feed non-food animals, such as pets. In the letter, manufacturers were encouraged to make sure they have procedures in place that ensure the safety of the products and ingredients in their products, as well as the safety of the packaging and processing supplies they use. In addition, manufacturers should also verify that their suppliers have such procedures in place. Guidance on these requirements is available at http://www.cfsan.fda.gov/~dms/alert.html.
As the letter noted, manufacturers are responsible for taking their own measures to ensure the safety of their marketed products. They should not wait for possible FDA testing of their materials before pursuing the necessary steps to achieve a high level of safety.
Screening procedure
Companies that are interested in performing their own tests for melamine and its analogs can refer to FDA's Web site at http://www.fda.gov/cvm/-GCMSMelamine.htm. The methodology used by the Food Emergency Response Network laboratories can be found there. As indicated at the link, this version (2.1, dated May 16, 2007) of the gas chromatography (GC) and mass spectrometry (MS) method for the presence of melamine, ammeline, ammelide, and cyanuric acid should be regarded as interim. This procedure was developed to screen various matrices for the presence of melamine and some related compounds at the established minimum reporting level of 10 micrograms per gram and above, using GC/MS. Samples are extracted using a mixture of acetonitrile/water/diethylamine, and the analytes are subsequently converted to trimethylsilyl derivatives for analysis.
Surveillance
As part of a protein ingredient surveillance assignment FDA issued on May 1, 2007, FDA, in conjunction with State regulatory authorities, has been performing inspections of various food and feed facilities. A variety of protein ingredients commonly used in food and feed manufacturing have been sampled and tested for the presence of melamine and melamine-related compounds, all of which are known as triazines. Protein concentrates such as wheat gluten, corn gluten, corn meal, soy protein, and rice protein concentrate imported from China or transshipped from China will be tested. During these inspections, FDA will point out the importance of ensuring the safety and security of the manufacturers' ingredients and products by knowing their manufacturing and packaging operators, ingredient suppliers, contract manufacturers, and sources for all incoming materials.
U.S. Ingredient Supplier Used Melamine
In a development unrelated to the pet food recall, a feed ingredient supplier that sells binding agents used to make pelleted feed products told the Food and
Drug Administration in May that the company had been using melamine, but has since stopped.
FDA reported on May 30 that Tembec BTLSR Inc., Toledo, OH, said it was using melamine to make two aquaculture products, AquaBond and Aqua-Tec II, which Tembec distributed for a second company, Uniscope, Inc., Johnstown, CO.
Uniscope also made a pellet binding ingredient, Xtra-Bond, using ingredients from Tempec that contained melamine.
FDA has advised feed manufacturers to recall finished feed made with AquaBond or Aqua-Tec II, due to the estimated levels of melamine and related compounds in the finished products.
Initial information has led FDA to believe that a recall is not needed for finished feed made with Xtra-Bond, because of the estimated low melamine level in the finished feed. However, as more information is obtained, there may be specific products or circumstances that could require a recall.
Food derived from animals fed these products is unlikely to pose a human health risk, FDA concluded, based on the interim risk assessment FDA and the U.S. Department of Agriculture conducted earlier in May.
International Activities
Chinese Food Safety, Trade Representatives at CVM
On June 19 CVM hosted the training of 14 food safety and trade specialists from China as part of a 7-week program sponsored by the Joint Institute for Food Safety and Applied Nutrition (JIFSAN). This program is one of several efforts by the U.S. Government to train developing countries in sanitary and phytosanitary requirements as members of the World Trade Organization. The day-long series of presentations by CVM technical experts covered veterinary drug approval procedures and review criteria and food and feed safety controls. Here, the Chinese visitors are listening to a presentation about regulations designed to prevent the spread of bovine spongiform encephalopathy.
The presentations at CVM were also attended by representatives of the U.S. Department of Agriculture's Food Safety and Inspection Service and the National Pork Producers Council.
http://www.fda.gov/cvm/FDAVet2007VolXXIINo2.htm#7042
blind leading the blind. ...tss
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/picren ... obtype=pdf
10,000,000+ LBS. of PROHIBITED BANNED MAD COW FEED I.E. MBM IN COMMERCE USA 2007
Date: March 21, 2007 at 2:27 pm PST
RECALLS AND FIELD CORRECTIONS: VETERINARY MEDICINES -- CLASS II
___________________________________
PRODUCT
Bulk cattle feed made with recalled Darling's 85% Blood Meal, Flash Dried, Recall # V-024-2007
CODE
Cattle feed delivered between 01/12/2007 and 01/26/2007
RECALLING FIRM/MANUFACTURER
Pfeiffer, Arno, Inc, Greenbush, WI. by conversation on February 5, 2007. Firm initiated recall is ongoing.
REASON
Blood meal used to make cattle feed was recalled because it was cross-contaminated with prohibited bovine meat and bone meal that had been manufactured on common equipment and labeling did not bear cautionary BSE statement.
VOLUME OF PRODUCT IN COMMERCE
42,090 lbs.
DISTRIBUTION
WI
___________________________________
PRODUCT
Custom dairy premix products: MNM ALL PURPOSE Pellet, HILLSIDE/CDL Prot-Buffer Meal, LEE, M.-CLOSE UP PX Pellet, HIGH DESERT/ GHC LACT Meal, TATARKA, M CUST PROT Meal, SUNRIDGE/CDL PROTEIN Blend, LOURENZO, K PVM DAIRY Meal, DOUBLE B DAIRY/GHC LAC Mineral, WEST PIONT/GHC CLOSEUP Mineral, WEST POINT/GHC LACT Meal, JENKS, J/COMPASS PROTEIN Meal, COPPINI – 8# SPECIAL DAIRY Mix, GULICK, L-LACT Meal (Bulk), TRIPLE J – PROTEIN/LACTATION, ROCK CREEK/GHC MILK Mineral, BETTENCOURT/GHC S.SIDE MK-MN, BETTENCOURT #1/GHC MILK MINR, V&C DAIRY/GHC LACT Meal, VEENSTRA, F/GHC LACT Meal, SMUTNY, A-BYPASS ML W/SMARTA, Recall # V-025-2007
CODE
The firm does not utilize a code - only shipping documentation with commodity and weights identified.
RECALLING FIRM/MANUFACTURER
Rangen, Inc, Buhl, ID, by letters on February 13 and 14, 2007. Firm initiated recall is complete.
REASON
Products manufactured from bulk feed containing blood meal that was cross contaminated with prohibited meat and bone meal and the labeling did not bear cautionary BSE statement.
VOLUME OF PRODUCT IN COMMERCE
9,997,976 lbs.
DISTRIBUTION
ID and NV
END OF ENFORCEMENT REPORT FOR MARCH 21, 2007
http://www.fda.gov/bbs/topics/enforce/2 ... 00996.html
TSS
