The Food Animal Residue Avoidance Databank: North Carolina Component

The types of information available through FARAD include basic veterinary drug registration information, withdrawal times, indications for use, as well as complex technical information about the pharmacokinetics and toxicokinetics of drugs and chemicals in food animals. FARAD was authorized by the Agricultural Research, Extension, and Education Reform Act of 1998 (AREERA) which required FARAD to provide the following: 1. provide livestock producers, extension specialists, scientists, and veterinarians with information to prevent drug, pesticide, and environmental contaminant residues in food animal products; maintain up-to-date information concerning a. withdrawal times on FDA-approved food animal drugs and appropriate withdrawal intervals for drugs used in food animals in the United States, as established under section 512(a) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360b(a)); b. official tolerances for drugs and pesticides in tissues, eggs, and milk; c. descriptions and sensitivities of rapid screening tests for detecting residues in tissues, eggs, and milk; & d. data on the distribution and fate of chemicals in food animals; 2. publish periodically a compilation of food animal drugs approved by the FDA; 3. make information on food animal drugs available to the public through handbooks and other literature, computer software, a telephone hotline, and the Internet; 4. furnish producer quality-assurance programs with up-to-date data on approved drugs; maintain a comprehensive and up-to-date, residue avoidance database; 5. provide professional advice for determining the withdrawal times necessary for food safety in the use of drugs in food animals; and 6. engage in other activities designed to promote food safety. Objective of the three collaborating universities is to continue the development and delivery of FARAD, and to utilize current technologies to make changes in FARAD which will improve its usefulness and utility as a decision support system. Five primary tasks include: 1. Extraction & validation of data for incorporation into the system and support for publication of the Food Animal Drug Compendiums in electronic format (VetGRAM) for INTERNET delivery. Extraction of relevant data from foreign drug compendia and gFARAD partners. 2. Operation of the Regional Access Centers (RAC's) in California and NC for dissemination of residue avoidance information, with access through the toll-free number and e-mail. 3. Data entry, pharmacokinetic analysis, maintenance, & distribution of the FARAD files. 4. Preparation of FARAD Digests for publication in the Journal of the AVMA & other publications for distribution. 5. Develop & validate methods to allow extrapolative techniques to be used in providing information and advice.

1. While the users of FARAD are veterinarians, regulatory agencies, and extension specialists, the ultimate client is the general public who can consume foods of animal origin that are free of harmful drug and chemical residues. 2. FARAD has evolved into an expert-mediated residue avoidance decision support system which is able to provide timely advice and information on a wide range of drug and chemical entities. 1. The goal of FARAD is the production of safe foods of animal origin through the prevention and mitigation of volatile chemical residues in food animal products. 2. The goals of this year's support for NCSU is continued operation of the national hotline center, complete implementation and testing of the EWE (Extrapolated Withdrawal Interval Estimator) algorithm to automatically calculate safe extra-label or environmental contaminant withdrawal intervals, and initial validation of in vivo residue monitoring approaches.

A. New compounds will be added as data become available about new compounds of residue concern. B. Compounds currently entered into FARAD will be updated C. The Regional Access Centers (RACs) will continue to service information requests on a national basis - The target response time is within 24 hours after receiving a request, however this may be much longer for contamination incidents. D. Updating of data file on rapid residue screening tests - Recent advances in biotechnology have made it possible for several companies to develop and market rapid systems for detecting drug residues in meat, milk, serum, urine and animal feeds. E. Preparation of Food Animal Drug Compendium and summary reports on chemicals of special concern - The data on approved drugs and environmental contaminants which is the focus of the Trades Database and is included in the Food Animal Drug Compendia, has continued to be collected on an ongoing basis and entered into the database. Thus the database includes not only the label information for approved drugs for food animals, but also the official tolerances in food of animal origin for chemicals and their products. F. Continued implementation of new FARAD INTRANET structure - The linkage of the three FARAD sites with one another through an INTRANET (established utilizing the INTERNET) such that the data entered at each site is instantly accessible at all sites, is essential to efficient operation and to insure consistency in the recommendations given for residue avoidance. The Trades files are available through the FARAD website, and a more extensive updated version is circulated to all FARAD sites on a monthly basis. G. FARAD data analysis and system integration - There is a massive amount of unique information contained within FARAD. These data can be used to model interspecies differences in residue disappearance from food animals. H. FARAD Digest - Each of the three FARAD centers has taken responsibility for the production of FARAD Digests for publication in the Journal of the American Veterinary Medical Association (JAVMA). I. Implementation of gFARAD (global FARAD) - In response to requests for help and information from overseas agencies and scientists, FARAD convened a meeting in Madrid, Spain in 1997 to formally initiate gFARAD and to offer assistance to fledgling National Access Centers in their formative period. J. Planning and Development for Validation of Residue Avoidance Algorithms - The initial validation step use residue surveillance and violation data from existing databases, (RVIS, TRIMS) to statistically confirm FARAD recommended withdrawal intervals. If FARAD were to achieve full funding, the final validation will be through direct controlled experimental studies or prospective trace-back studies.