Citing stakeholder concerns over insufficient time to develop meaningful submissions, the U.S. Food and Drug Administration (FDA) has extended by 90 days the period in which to submit comments about the agency’s risk assessment titled, “Multicriteria-Based Ranking Model for Risk Management of Animal Drug Residues in Milk and Milk Products.” FDA seeks suggestions for improving the specific criteria, scoring and weighting scheme; selection of animal drugs evaluated; and transparency of the risk assessment. Electronic or written submissions are now due by October 27, 2015. See Federal Register, July 30, 2015. Issue 573
Tag Archives veterinary
The Center for Food Safety and two other public interest organizations have filed a lawsuit against the U.S. Food and Drug Administration (FDA) seeking to overturn its approval of 11 animal drugs containing ractopamine hydrochloride on the ground that the agency failed to undertake the analysis purportedly required under the National Environmental Policy Act (NEPA) before approving them. Ctr. for Food Safety v. Hamburg, No. 14-4932 (N.D. Cal., filed November 6, 2014). The Center previously petitioned FDA to reduce the allowable levels of ractopamine, administered in animal feeds to boost growth and leanness in meat production, and to study its potential effects on human health and animal welfare. Information about the petition appears in Issue 466 of this Update. The complaint sets forth the effects these drugs allegedly have on livestock, like pigs, and on the environment. The plaintiffs claim that the company that makes ractopamine has acknowledged the “risk…
SHB’s Public Policy Group recently contributed to a favorable outcome for animal medicine manufacturers in the Supreme Court of Texas, which ruled in Strickland v. Medlen that emotion-based damages, including loss of companionship and sentimental damages, are not permitted in pet injury claims in Texas. Presenting on behalf of amici during oral argument, SHB Partner Victor Schwartz highlighted the public policy issues at stake after a lower appellate court in Texas broke with the majority of courts nationally by allowing broad, new emotion-based damages for pet deaths in a November 2011 ruling. SHB Partner Phil Goldberg authored the amici brief on behalf of the Animal Health Institute and several animal health organizations, developed other amici and helped prepare defense counsel on key issues, while Partner Manuel Lopez served as local counsel on the SHB amici brief and provided expertise on the appellate process. In its ruling, the court ultimately recognized that finding…
The U.S. Department of Justice (DOJ) has reportedly indicted a London, Kentucky-based cattle company and its treasurer for falsifying records related to a federal investigation and creating false documents. The charges apparently arise out of a Food and Drug Administration (FDA) investigation to determine whether the company was violating a 2006 court-ordered injunction requiring it to notify buyers if the company sells them animals with medical drugs in their systems. The order also requires the company to “identify the potential cause for the medical drugs in the animals and to refrain from purchasing animals from sellers who supply cattle that contain medical drugs.” Williams Cattle Co. treasurer Pamela Collette allegedly “falsified weekly reports that were supposed to be sent to buyers verifying that the animals sold were drug free, in an attempt to influence the outcome of the investigation. She is also alleged to have created false documents that appeared…
The Food and Drug Administration (FDA) has issued a proposed rule that would update tolerances “for residues of approved and conditionally approved new animal drugs in food by standardizing, simplifying, and clarifying the determination standards and codification style.” According to FDA, the regulations describing how to set animal drug tolerances for human food are not uniform, do not provide all relevant information, and “no longer accurately reflect current regulatory science.” “For example, the regulations provide the ADI [acceptable daily intake] and safe concentrations for some, but not all, drugs,” states the proposed rule. “In addition, the regulations list some tolerances as being for ‘negligible’ residue, and others as ‘no residue,’ ‘zero’ or ‘not required,’ but they do not explain what these important terms mean. The proposed rule addresses these inconsistencies by simplifying and standardizing the determination standards and codification style and by adding definitions for key terms.” FDA will accept…
The Food and Drug Administration (FDA) has extended the comment period for an advanced notice of proposed rulemaking (ANPR) that announced potential changes to regulations governing new antimicrobial animal drug reporting. The ANPR proposed altering these regulations to incorporate the requirements of section 105 of the Animal Drug User Fee Amendments of 2008 (ADUFA 105). FDA has requested public comments “on how best to compile and present the summary information as directed by ADUFA 105, and on alternative methods available to the Agency for obtaining additional data and information about the extent of antimicrobial drug use in food-producing animals.” FDA has extended the comment period at the request of responders until November 26, 2012. See Federal Register, September 26, 2012.
The Food and Drug Administration (FDA) recently announced the availability of its draft Foods and Veterinary Medicine Strategic Plan 2012 – 2016, which takes into account “all of the activities within the jurisdictions of the Center for Food Safety and Applied Nutrition and the Center for Veterinary Medicine and includes activities supported by the Office of Regulatory Affairs.” According to the executive summary, the Foods and Veterinary Medicine (FVM) Program aims to protect the American food supply by securing high rates of compliance with science-based food safety and labeling standards as well as implementing “integrated, prevention-oriented and risk-based programs.” To this end, the 2012-2016 plan identifies one cross-cutting goal—to “improve effectiveness and efficiency across all levels of the FVM program”—as well as seven program goals: (i) “Establish science-based preventive control standards across the farm-to-table continuum”; (ii) “Achieve high rates of compliance with preventive control standards domestically and internationally”; (iii) “Strengthen…
The U.S. Department of Agriculture (USDA) has announced its intention to abandon the National Animal Identification System (NAIS) and develop a “new, flexible framework for animal disease traceability,” citing public feedback and input from states, tribal nations, industry groups, and small and organic farmers. Created in 2004, NAIS aimed to register all domestic livestock in a national database to facilitate the response of state and federal officials during a disease outbreak. The system apparently drew criticism from many quarters that objected to both the cost and intrusiveness of the measure, which some felt would eventually become mandatory. Unveiled at the National Association of State Departments of Agriculture (NASDA) Mid-Year Meeting, the new initiative outlines “the basic tenets of an improved animal disease traceability capability in the United States.” According to USDA, this framework will (i) “Only apply to animals moved in interstate commerce”; (ii) “Be administered by the States and…
