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U.S. Department of Health and Human Services

Animal & Veterinary

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CVM Plans Second Risk Assessment on the Use of Antimicrobials in Food-Producing Animals

April 5, 2001

The Food and Drug Administration's Center for Veterinary Medicine (FDA's CVM) has decided to conduct a quantitative risk assessment on the human health impact of the development of the streptogramin (quinupristin/dalfopristin [QD]) resistant Enterococcus faecium in humans that is associated with the use of streptogramins (virginiamycin) in food-producing animals.

The drug Synercid™, a streptogramin (QD), was approved in September 1999 for the treatment of vancomycin-resistant E. faecium infections, as well as other gram-positive bacterial tissue infections in humans. Virginiamycin has been used for therapeutic and growth promotion purposes in chickens for 26 years. It has also been used for similar purposes in swine, cattle, and turkeys.

CVM initiated a feasibility study to determine whether sufficient data exist to support a quantitative model or if additional data need to be generated. On April 19, 2000, CVM announced the plan to develop the risk assessment, requested comments on the plan, and asked for the submission of relevant scientific data and information. This feasibility study has been completed, and CVM has determined that there are sufficient data either available or forthcoming to support a quantitative risk assessment of the human health impact from the use of virginiamycin in food-producing animals. Because some of the data needed for the risk assessment are currently under development, it will take a year or more to complete.

In January 1999, CVM released a discussion paper, A Proposed Framework for Evaluating and Assuring the Human Safety of the Microbial Effects of Antimicrobial New Animal Drugs Intended for Use in Food-Producing Animals (known as the Framework Document.) The Framework Document provides a conceptual risk-based framework for evaluating the risks to human health associated with the development of resistant bacteria arising from the use of antimicrobials in food-producing animals. Later in January 1999, FDA's Veterinary Medicine Advisory Committee discussed the Framework Document and heard from the public. Many comments from stakeholders asked that increased regulatory action not be implemented until risk assessments demonstrate a significant impact on public health.

CVM has completed a quantitative risk assessment that modeled the human health impact of fluoroquinolone resistant Campylobacter infections associated with the consumption of chicken. It demonstrated the extent of the adverse impact of fluoroquinolone use in poultry on human


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Issued by: FDA, Center for Veterinary Medicine

Communications Staff, HFV-12

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