The U.S. Department of Agriculture’s National Organic Program (NOP) has issued a final rule revising the National List of Allowed and Prohibited Substances with regard to the use of tetracycline, formic acid and attapulgite during the production and processing of organic crops and food ingredients. According to NOP, the most recent iteration of the National List permitted the use of tetracycline “for fire blight control only” in apple, pear and other organic fruit crops until October 21, 2012. The final rule has amended the National List to specify that the substance can be used to control fire blight in apple and pear crops only and to extend the expiration date until October 12, 2014. In addition, NOP has added formic acid to the National List “solely for use as a pesticide within honeybee colonies” to suppress infestations of Varroa mites and approved attapulgite, a substance generally regarded as safe by the…
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A federal court in Wisconsin has reportedly approved a consent decree between the U.S. government a Wisconsin livestock operation that allegedly violated federal drug laws by failing to maintain adequate animal treatment records, using new animal drugs illegally and failing to adequately distinguish between medicated and non-medicated animals for sale for use as human food. The Food and Drug Administration (FDA) initially warned the owner of Nolan Livestock in 2004 that a U.S. Department of Agriculture inspection revealed the presence of an illegal antibiotic in the edible tissues of its dairy cows. Under the consent decree, the owner must cease operations and then resume only when it has documented to FDA’s satisfaction that it has corrected the problems observed and has instituted appropriate procedures to prevent a recurrence. See U.S. Department of Justice News Release, June 26, 2012; FDA News Release, July 10, 2012.
U.S. Representative Louise Slaughter (D-N.Y.) has released the responses to a February 16, 2012, letter sent to 60 food producers and retailers “asking them to disclose their policies on antibiotic use in meat and poultry production.” After analyzing the results, Slaughter has purportedly revealed that “while a small number of industry leaders provide antibiotic-free meat and poultry products, an overwhelming majority of food production companies routinely feed low-doses of antibiotics to healthy food-animals.” In particular, Slaughter has used these findings to bolster support for the Preservation of Antibiotics for Medical Treatment Act (PAMTA), “which would end the routine use of antibiotics on healthy animals” and “preserve the effectiveness of medically important antibiotics.” To this end, she has also highlighted a recent Consumers Union report, “Meat On Drugs,” as evidence that consumers would purchase antibiotic-free products in supermarkets. “Through my survey, the food industry has provided us valuable information, and with…
The Council of the European Union has issued a “One Health” perspective document recognizing that antimicrobial resistance (AMR) “is accelerated by excessive and inappropriate use of antimicrobial agents” and asking member states to “develop and implement national strategies or action plans for countering AMR.” According to the perspective document, which underlined the need for “an active holistic approach” to combating AMR, “some practices in human and in animal healthcare including the possible incentives deriving from the prescription and subsequent sale of antimicrobial agents may lead to inappropriate use and overuse of antimicrobial agents.” In particular, the Council has advocated restrictions on both the human and veterinary use of critically important microbials (CIAs) and newly developed microbials “with the aim in the future to reserve CIAs as much as possible for human use.” To this end, the Council has requested that member states curb the prophylactic use of all antimicrobials while…
A federal court in New York has determined that the Food and Drug Administration (FDA) arbitrarily denied petitions filed by advocacy organizations in 1999 and 2005 requesting the initiation of proceedings to withdraw approval from certain uses of antibiotic drugs in livestock. Nat. Res. Defense Council v. FDA, No. 11-3562, (S.D.N.Y., decided June 1, 2012). The ruling follows the court’s March 2012 grant of summary judgment to the plaintiffs on their first claim for relief. Additional information about that ruling appears in Issue 432 of this Update. The most recent ruling relates to the third claim for relief, that is, whether FDA violated the Administrative Procedure Act when it denied the two petitions “requesting that the FDA withdraw approval of certain uses of certain classes of antibiotics in food-producing animals.” The court first determined that it had subject matter jurisdiction over the claim, disagreeing with FDA’s assertion that its November 2011 decision…
University of Almeria researchers have reportedly used a new “multi-residue” technique to identify veterinary drug residues in baby food, raising concerns about the need to better regulate the substances permitted in animal-based products. M.M. Aguilera-Luiz, et al., “Multiclass method for fast determination of veterinary drug residues in baby food by ultra-high-performance liquid chromatography tandem mass spectrometry,” Food Chemistry, June 2012. The study’s authors evidently analyzed 12 meat products containing beef, pork or poultry and nine milk powder samples, all of which purportedly contained trace amounts of antibiotics, including sulfonamides and macrolides, as well as anthelmintics and fungicides. In particular, the results allegedly showed higher concentrations of veterinary drug residues in chicken and other poultry products. “The concentrations detected have been generally very low,” one of authors was quoted as saying. “On one hand, this suggests they are not worrying amounts, on the other hand, it shows the need to control…
A group calling itself “Supermoms Against Superbugs” reportedly gathered in Washington, D.C. recently to lobby for greater limits on antibiotics used in U.S. food production. Organized by the Pew Campaign on Human Health and Industrial Farming and the American Academy of Pediatrics, the coalition included chefs, farmers, pediatricians, and consumers who participated in meetings with congressional staff, the Food and Drug Administration, and the White House Domestic Policy Council. See Pew Campaign on Human Health and Industrial Farming Press Release, May 15, 2012.
Referring to a report on the presence of antibiotic residues in distillers grain, an ethanol-production byproduct used as animal feed, U.S. Representatives Edward Markey (D-Mass.) and Louise Slaughter (D-N.Y.) have requested that Food and Drug Administration (FDA) Commissioner Margaret Hamburg provide information about the agency’s surveys of these residues and explain why FDA has not acted to ensure that ethanol producers are complying with federal food additives law. In their May 11, 2012, letter, the lawmakers contend that the misuse of antibiotics leads to the growth of antibiotic-resistant bacteria that threaten human health and results in the deaths of some 90,000 people annually. They note, “[t]he same antibiotics that are used in animal agriculture and that are important for human medicine such as penicillin, erythromycin, virginiamycin and tylosin, are also used by ethanol producers in order to prevent bacterial growth during the corn-based ethanol fermentation process. Producers sell the byproduct…
The Food and Drug Administration (FDA) has released industry guidance and a draft regulation about a new voluntary initiative intended to decrease the use of antimicrobials in agricultural animals. According to an April 11, 2012, press release, FDA has issued final guidance for industry titled “The Judicious Use of Medically Important Antimicrobial Drugs in Food-Producing Animals,” which “recommends phasing out the agricultural production use of medically important drugs and phasing in veterinary oversight of therapeutic uses of these drugs.” The agency has also published draft guidance that urges animal pharmaceutical companies to voluntarily remove “production uses of antibiotics from their FDA-approved product labels” and “add, where appropriate, scientifically-supported disease prevention, control, and treatment uses.” These two sets of guidance are supplemented with a proposed veterinary feed directive outlining “ways that veterinarians can authorize the use of certain animal drugs in feed, which is important to make the needed veterinary oversight feasible…
A federal magistrate judge in New York has ordered the Food and Drug Administration (FDA) to begin proceedings to withdraw approval for the subtherapeutic use of certain antibiotics in animal feed, agreeing with the Natural Resources Defense Council (NRDC) and a coalition of advocacy organizations that the agency had a statutory duty to hold withdrawal proceedings after issuing notices in 1977 of its intent to withdraw approval because the use of such drugs had not been shown to be safe. NRDC v. FDA, No. 11-3562 (S.D.N.Y., decided March 22, 2012). According to the court, “if the Secretary finds that an animal drug has not been shown to be safe, he is statutorily required to withdraw approval of that drug, provided that the drug sponsor has notice and an opportunity for a hearing.” Further details about the lawsuit appear in Issue 396 of this Update. Questions about whether the agency has…