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=- B-J Townsend Townsends, Inc. Poultry Products Group P.O. Box 468 Millsboro, Delaware 19966 (302) 934-9221 February 7,200O Dockets ManagementBranch (HFA-305) Food and Drug Administration 5630 FishersLane, Room 1061 Rockville, MD 20852 Re: Docket Number 98D-0969 To Whom It May Concern: I am writing in regards to the proposed ‘Risk Assesementon the Human Health Impact of Fluoroquinilone ResistanctCampylobacter Associated with the Consumption of Chicken” being developed by CVM/FDA. I have read the letter jointly submitted by The National Chicken Council and Association of Veterinarians in Broiler Production and am in full support of that document. Severalpoints that I think should be emphasizedare; The risk assessmentdoes NOT evaluatethe development of resistanceto fluoroquinilones as a consequenceof treatment of chickens with that drug. The model assumesthat all chickens are treated with fluoroquinilone which is not the case. FDAKVM is well aware that a very small percentageof poultry flocks are treated with fIuoroquiniIones. AIong that line, no data are availableto determine the level of inate resistancein Campylobacter as no sensitivity testing was conducted prior to introduction of the drugs to the poultry industry in 1995. While researchis in progress, no one currently knows the epidemiology of Campylobacter, much lessthe method of tr ansmissionto poultry. This is a critical fact to understandwhen trying to learn how the bacterium developsresistanceto any antimicrobial drug, including fluoroquinlones. In the isolation and testing proceduresused in the laboratory, nalidixic acid is used as a screeningmethod to eliminate other speciesof Campylobacter from testing. Such a procedure appearsto bias the resistanceprofile as nalidixic acid resistanceis consideredby many to be a precursor to development of resistanceto fluoroquinlones. While I recognize that decisionsmust often be made before facts are completely understood scientifically, my overall concern with the risk assessmentis that scienceis not even being used to direct the philosophy of development and usageof antibacterial drugs in food producing animals. Rather it appearsthat facts and statementsare being manipulated to a predetermine end result- ie - all resistant bacteria come f?om usageof antibacterial drugs in food producing animals. Thank you for taking time to read and evaluatemy letter and if1 can be of further assistancepleasecontact me. Corporate Veterinarian Gen/fqcvnQOO i t