Public Employees for Environmental Responsibility (PEER) has posted to its website documents relating to the use of antimicrobial drugs in livestock feed received from the Food and Drug Administration (FDA) under a Freedom of Information Act request. According to PEER, internal memos show that FDA is not, as the agency has claimed, working successfully with industry to phase out this use of antimicrobials, estimated at 30 million pounds in feed troughs annually. PEER claims that “70,000 Americans die each year from drug-resistant infections” and that the “rise of drug-resistant ‘super diseases’ is driven by overuse and misuse of antimicrobial drugs in livestock feed primarily to promote livestock growth.” In litigation, FDA defended its failure to timely follow through on proceedings to withdraw from use two antimicrobials by claiming that it had abandoned formal rulemaking in favor of more effective voluntary measures. Details about a court order requiring that FDA initiate…
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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…
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…
Part II of the American Bar Association’s (ABA’s) Nanotechnology Project, this recently released book comprehensively considers, by product category, how the Food and Drug Administration (FDA) reviews nanotechnology-based products. Shook, Hardy & Bacon Agribusiness & Food Safety Attorney James Andreasen was among those practitioners contributing to the work. Among the chapters are “Color Additives,” “Food Additives and Related Substances,” “Dietary Supplements,” “Food and Animal Feed Products,” and “Biological Products.” They address “how FDA can, and to some extent, has, regulated nanomaterials in products falling under its multiple areas of responsibility,” and (i) identify “products that already feature nanomaterials”; (ii) review “FDA’s regulatory program for the specific product category (such as particular pre-market and post-market controls)”; and (iii) discuss “how that program might apply to nanomaterials.”
The U.S. Department of Agriculture’s National Organic Program (NOP) has issued a proposed rule that would regulate the use of synthetic methionine in organic poultry production after a current interim final rule expires on October 1, 2012. According to a February 6, 2012, Federal Register notice, the rule would amend the National List of Allowed and Prohibited Substances (National List) to permit the following maximum levels of synthetic methionine per ton of feed: (i) two pounds for laying and broiler chickens; and (ii) three pounds for turkey and all other poultry. NOP has requested public comments on the proposed rule by April 6. The National List currently classifies methionine “as an essential amino acid because it cannot be biologically produced by poultry and is necessary to maintain viability.” The substance occurs naturally in feed sources that include blood meal, fish meal, crab meal, corn gluten meal, alfalfa meal, and sunflower…
The U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) has announced a January 18, 2012, public meeting in Washington, D.C., to consider draft U.S. positions to be presented during the 6th session of the Ad Hoc Intergovernmental Task Force on Animal Feeding of the Codex Alimentarius Commission on February 20-24 in Berne, Switzerland. The January agenda includes discussion of draft risk assessment guidelines for feed and a proposed list of feed hazards. See Federal Register, November 17, 2011.
The Food and Drug Administration (FDA) has issued a final rule requiring animal and pet food labels to list “the common or usual names” of any certified color additives used in the products. Issued in response to the Nutrition Labeling and Education Act of 1990, the final rule brings animal food labeling in line with current human food regulations by adding “paragraph (k) to the animal food labeling regulations at § 501.22 (21 CFR 501.22).” The first part of paragraph (k) explains that any FDA-certified color additive used in animal foods “must be declared in the ingredient list” under the name listed in 21 CFR part 74 or 21 CFR part 82, although manufacturers are permitted to “parenthetically declare an appropriate alternative name of the certified color additive following its common or usual name.” In addition, the new rules require that the term “Lake” be included “in the declaration of…
The European Commission (EC) has reportedly endorsed proposed safety measures aimed at better preventing dioxin contamination in animal food and feed. Prompted by a widespread investigation into an outbreak of the toxin that struck German meat and egg farms in late 2010, the draft regulation will be sent to the European Parliament and the European Council for review before the EC can give its official approval. Implementation is expected throughout the European Union by mid-2012. Details of the outbreak were covered in Issues 376, 377 and 381 of this Update. According to the EC, Germany’s dioxin outbreak occurred when fatty acids intended for technical and industrial use were mixed with vegetable feed fat used in the production of animal feed. To reduce such risks from happening in the future, EU member states approved EC Standing Committee on the Food Chain and Animal Health safety measures designed to “avoid food recalls…
A number of former employees of an animal-food flavoring maker have sued companies that make or sell the butter-flavoring chemical diacetyl, alleging that occupational exposure caused them to contract a debilitating lung disease known as bronchiolitis obliterans (or popcorn lung). Huerta v. Aldrich Chem. Co., Inc., No. 11-9461 (Ill. Cir. Ct., Cook Cty., filed September 9, 2011). The 112-count complaint alleges negligence, strict liability design defect and failure to warn, conspiracy, and loss of consortium. The plaintiffs seek unspecified compensatory damages. According to the complaint, “Defendants knew or should have known of the hazardous nature of their diacetyl and diacetyl-containing flavors both at the time of sale and when plaintiffs were exposed to such products while working at the Feed Flavors facility. [Yet], defendants failed to warn of the defective nature of their flavoring chemicals and failed to give instructions on safe use of the flavoring chemicals.”
A bipartisan group of senators has introduced a bill (S. 1211) aimed at phasing out routine use of antibiotics in food-producing animals. Spearheaded by U.S. Senator Dianne Feinstein (D-Calif.), the Preservation of Antibiotics for Medical Treatment Act (PAMTA) is identical to a House bill (H.R. 965) introduced earlier this year by U.S. Representative Louise Slaughter (D-N.Y.), who has championed such legislation since 2007. PAMTA “addresses the rampant overuse of antibiotics in agriculture that creates drug-resistant bacteria, an increasing threat to human beings,” Feinstein noted in a press release. The legislation would also (i) “require new applications for animal antibiotics to demonstrate (that) the use of the antibiotic will not endanger public health” and (ii) “not restrict the use of antibiotics to treat sick livestock or to treat pets.” The bill’s provisions would limit agricultural use of seven types of antibiotics identified by the Food and Drug Administration as “critically important…
