Docket Management
Docket: 98D-1146 - Eval. the Safety of Antimicrobial NADs Re. their Microbiological Effects on Bacteria of Human Health Concern
Comment Number: EC -11

Accepted - Volume 2

Comment Record
Commentor Dr. Dennis Wages Date/Time 2002-11-26 17:47:57
Organization American College of Poultry Veterinarians
Category Individual

Comments for FDA General
1. General Comments Reference: Review of Docket No. 98D-1146, Draft Guidance for Industry #152, Evaluating the Safety of Antimicrobial New Animal Drugs with Regard to Their Microbiological Effects on Bacteria of Human Health Concern. Dear Sir/Madam: This submission is made on behalf of the more than 210 Diplomates of the American College of Poultry Veterinarians. This professional association, chartered in 1991 by the American Board of Veterinary Specialties, a constituent body of the American Veterinary Medical Association, promotes the health and productivity of commercial poultry and indirectly contributes to the well﷓being of US citizens by providing wholesome eggs, turkey and broiler meat with an aggregate value exceeding $20 billion annually. Diplomates of the College are involved in a number of activities including disease prevention, production management, diagnostic services, technical support for biologics and pharmaceutical manufacturers, and primary breeders. Diplomates are also involved in regulatory activities at the Federal and State levels and are responsible for research and instruction of professional and post﷓graduate students. We are concerned about how the ranking of the antimicrobials was performed with respect to their importance in human medicine. The importance of the rankings of antimicrobials is evident in 2 of the 3 parts of the risk assessment for hazard identification and in the consequence assessment. We feel that the ranking process should be made more transparent. The ranking should be made based on bacteria that are foodborne. When one reads this document, it can be interpreted that food animal use of antimicrobials impact all the diseases and conditions listed in Guidance #152. The focus of the antimicrobial rankings should be related to foodborne bacteria and/or cross-resistance to foodborne bacteria. We feel that the exposure assessment, based on per capita consumption, over estimates the true exposure to humans. Over 50% of the chicken and over 75% of the turkey is consumed as value added product, i.e., it has been further processed or cooked so as to drastically minimize if not eliminate human exposure to raw product and food borne pathogens. If foodborne bacteria exposure is truly the agency’s concern, further processing of poultry products must be considered in the exposure assessment. With respect to the exposure assessment, we feel that overall contamination of product is not an accurate reflection of human exposure. A quantitative assessment to determine an average number of foodborne bacteria that are actually contaminating meat more accurately reflects the true hazard to humans. Simple prevalence data for foodborne bacterial contamination on product does not reflect true human exposure and risk. What is the disposition of an antimicrobial if it is used in an animal commodity species in which the final product is irradiated? We feel if an industry progresses to product irradiation all antimicrobials used in that species should be of low risk, i.e. no human exposure, no risk. Referring to the consequence assessment, we feel that this may undermine the extra label drug use law (AMDUCA) and impact the interpretation of judicious therapeutic use guidelines. Defining other use criteria and not allowing veterinarians to make informed decisions as to the use of a product based on Guidance #152 seems to supersede AMDUCA. This document clearly targets the practice of population medicine. Placing flock and herd treatments in high-risk categories based on duration of therapy and numbers of animals treated, clearly puts animal agriculture in a competitive disadvantage. Disease prevention therapy will be assessed as high risk based on duration of therapy. Is there any scientific data that supports increased human exposure and/or risk from flock or herd treatments? We appreciate the difficulty in addressing the agency’s concern for antimicrobial resistance, especially in foodborne pathogens. However, we feel that there are areas within Guidance #152 that are of concern for poultry veterinarians, and have been addressed. We would also like to add our support to comments made by the American Veterinary Medical Association at he public meeting as well the AVMA’s written comments. Thank you, Dennis P. Wages, DVM, Dipl. ACPV President, American College of Poultry Veterinarians

EC -11