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15 FDA Veterinarian 1 (2000)

handle is hein.animal/fdavt0015 and id is 1 raw text is: US HE 20.4410:15/1. DO(UMENTRI OjDICA January/February 2000 DOES NOYNVol. XV, No. I FDA VE?1'JAM ANTIMICROBIAL RESISTANCE DOCUMENTS AVAILABLE F DA has made available three documents on antimicrobial resis- tance in food-producing animals. The first document is a draft Risk As- sessment on the Human Health Im- pact of Fluoroquinolone Resistant Campylobacter Associated with the Consumption of Chicken. To assist in evaluating the human health im- pact of antimicrobial use in animals, the Center contracted with a risk assessment expert to develop a risk assessment model. The risk assess- ment was intended to determine the feasibility of estimating risk to hu- man health from resistant foodborne pathogens associated with the use of antimicrobials in food-producing animals. Specifically, a mathemati- cal model was derived to relate the prevalence of fluoroquinolone resis- tant Campylobacter infections in hu- mans associated with the consump- tion of chicken to the prevalence of fluoroquinolone resistant Campylo- bacter in chickens. The concern exists for several rea- sons. First, chickens carry foodborne pathogens, including Campylobacter and Salmonella. An estimated 20 percent of broiler chickens in the U.S. are contaminated with Salmonella, and more than 80 percent are con- taminated with Campylobacter. Sec- ond, Campylobacter is the most com- mon known cause of bacterial foodborne illness in the United States. Epidemiological investiga- tions have found that chicken is the most common source of human in- fection. Third, Campylobacter appar- ently can develop resistance quickly when fluoroquinolones are used in both human and veterinary medicine. Fourth, fluoroquinolones are used in human medicine to treat gastrointes- tinal infections, such as campylobac- teriosis and are important for use in many other therapeutic indications in human medicine. The risk assess- ment model could become a regula- tory tool for assessing such risks in the future. This document is on CVM's Home Page on the Internet at: http://www.fda.gov/cvm/fda/ mappgs/ra/risk.html The second document is a revision of the Guidance for Industry: Con- sideration of the Human Health Impact of the Microbial Effects of Anti- microbial New Animal Drugs In- tended for Use in Food-Producing Animals (CVM guidance document 78.) This guidance document now states that FDA believes it is neces- sary to consider the potential human health impact of the microbial effects associated with all uses of all classes of antimicrobial new animal drugs in- tended for use in food-producing animals. To assess this impact, it may be necessary to evaluate two separate, but related aspects (1) the rate and extent of development of antimicrobial drug resistant enteric bacteria formed in the animal's in- testinal tract following exposure to the antimicrobial new animal drug (re- sistance), and (2) changes in the number of enteric bacteria in the animal's intestinal tract that cause human illness (pathogen load.) Cop- ies of the revised guidance document may be obtained from CVM's Internet Home Page (http:// www. fda.gov/cvm/fda/TOCs/ guideline.html) (Continued, next page) PROTECTING PETS IN A DISASTER by Karen A. Kandra and Mary Cacia Masser, D. V.M. The following article provides infor- mation on protecting pets in a disas- ter. Veterinarians may wish to dupli- cate this article and provide copies to their interested clients. As always, material which appears in the FDA Veterinarian is free of copyright and may be reproduced without permis- sion. W hen we think of disasters we usually envision large-scale emergencies, such as earthquakes, floods, tornadoes, etc. However, much more common are personal disasters, which could be just as (Continued, next page) In This Issue Update on Antimicrobial Resistance Workshop .......... 3 What is VICH? ... ......... 6 Update on Rimadyl®............. 9 FDA's Regulation of Pet Food ..... ......... 11 U.S DEPARTMENT OF HEALTH AND HUMAN SERVICES PUBLIC HEALTH SERVICE FOOD AND DRUG ADMINISTRATION CENTER FOR VETERINARY MEDICINE f&ik

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