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CVM’s Participation in the Codex Committee on Residues of Veterinary Drugs in Foods and the Ad Hoc Intergovernmental Task Force on Antimicrobial Resistance

The Codex Alimentarius Commission was created in 1963 by FAO and WHO to develop food standards, guidelines and related texts such as codes of practice under the Joint FAO/WHO Food Standards Programme. The main purposes of this Programme are protecting health of the consumers and ensuring fair trade practices in the food trade, and promoting coordination of all food standards work undertaken by international governmental and non-governmental organizations.

Codex Committee on Residues of Veterinary Drugs in Foods (CCRVDF)

The objectives of the CCRVDF are to recommend MRLs for veterinary drugs in foods and to develop codes of practice as may be required. Codex MRLs are the maximum concentrations of residues resulting from the use of veterinary drugs that are recommended by the Codex Alimentarius Commission to be permitted or recognized as acceptable in or on a food. MRLs are based on the type and amount of residue considered to be without any toxicological hazard for human health as expressed by the Acceptable Daily Intake. Experts from CVM have served as the Chair of the CCRVDF and as the lead (the U.S. Delegate) for the U.S. Delegation to the CCRVDF since the committee began in 1986.

The responsibility for providing advice on risk management concerning residues of veterinary drugs lies with the CCRVDF and the Codex Alimentarius Commission. The responsibility for risk assessment lies primarily with the Joint FAO/WHO Expert Committee on Food Additives (JECFA). CVM technical experts in toxicology and chemistry also serve as members of the JECFA. So JECFA provides independent scientific advice in the form of a risk assessment based on available scientific data and the CCRVDF bases its risk management decisions upon that advice.

The CCRVDF either recommends the MRLs as proposed by JECFA, modifies them in consideration of other legitimate factors, considers other measures or asks JECFA for reconsideration of the residue evaluation for the veterinary drug in question.

The CCRVDF held its 19th Session in Burlington, Vermont on August/September 2010. This meeting was attended by 184 delegates from 58 countries and seven international organizations. At the meeting the CCRVDF advanced a number of MRLs through the Codex Step Elaboration Procedure and added a number of compounds to the priority list of veterinary drugs for evaluation or re-evaluation by JECFA. The CCRVDF agreed to consider the development of a policy for extrapolation of MRLs to additional species and tissues and to establish an electronic working group led by Canada to carry out this work; to establish an electronic working group led by the United States to continue developing and maintaining a database on the need for MRLs of developing countries and identifying data gaps and sources of data; to convene an expert consultation to review the current consumption estimation approaches used by JECFA with a view to developing more useful methods; to establish an electronic working group led by the European Union to develop risk management recommendations for a number of veterinary drugs for which no ADI and/or MRL has been recommended by JECFA due to specific human health concerns; to establish an electronic working group led by the United Kingdom to collate data from national authorities which have authorized veterinary drugs for use in bees from which honey is harvested for human consumption to consider criteria used by these national authorities, and to propose a risk assessment policy for JECFA to set limits for veterinary drugs in honey; to establish an electronic working group chaired by the United States refined the sampling plans for aquatic animal products and derived edible products of aquatic origin that are contained in the Guidelines for the Design and Implementation of National Regulatory Food Safety Assurance Programmes Associated with the Use of Veterinary Drugs in Food Producing Animals, and to charge this working group with revising the guidelines to describe the appropriate minimum quantity required for laboratory sample in the context of current analytical technology and the number and size of subsamples required; and to establish an electronic working group co-chaired by France, the United States, and Japan to revise the current risk analysis principles applied by the CCRVDF and the risk assessment policy for setting MRLs.

CODEX Ad Hoc Intergovernmental Task Force on Antimicrobial Resistance

Since 2007 CVM experts have actively participated in the Codex Alimentarius ad hoc Intergovernmental Task Force on Antimicrobial Resistance (TFAMR) and CVM has led the U.S. Delegation to the TFAMR for the U.S. Government. The work of the TFAMR will result in internationally recognized guidance that national governments will be able to use to appropriately assess and manage the risk from antimicrobial resistance that may occur as a result of the use of antimicrobial drugs in veterinary medicine. Such guidance is essential so that the regulation of the use of antimicrobials in food-producing animals will be based on a rational approach that uses objective evidence to determine the degree of risk. The TFAMR was created by the 2006 Codex Alimentarius Commission and has been hosted by the Republic of Korea since its first meeting in October 2007.

The Task Force was assigned the task of developing guidance to assess the risks to human health associated with the presence of antimicrobial resistant microbes and resistance genes in food and feed, including aquaculture, and their transmission through food and feed. It was also charged with developing appropriate risk management strategies. The goal of this work is to develop an antimicrobial resistance risk analysis approach under the Codex that allows countries or regions to implement actions based upon identified and prioritized needs and resources.

The Task Force was divided into subgroups on risk profiling, risk assessment, and risk management. Each of these subgroups created a draft guidance on its respective topic. During 2007-08, CVM led the subgroup that focused on preliminary risk management priority setting issues. During 2009, the CVM served as the chair of the electronic working group that was given the responsibility of merging the different draft guidances into a single document. CVM has also served as the U.S. Delegate to the TFAMR throughout its four year term. The TFAMR made significant progress at its fourth meeting in October 2010 and forwarded the proposed draft guidelines to the Codex Commission for its adoption at Step 5.