Source: UNIVERSITY OF FLORIDA submitted to
FOOD ANIMAL RESIDUE AVOIDANCE DATABANK (FARAD) PROGRAM: UNIVERSITY OF FLORIDA COMPONENT
Sponsoring Institution
National Institute of Food and Agriculture
Project Status
TERMINATED
Funding Source
Reporting Frequency
Annual
Accession No.
1003699
Grant No.
2014-41480-22169
Project No.
FLAW-2014-07825
Proposal No.
2014-07825
Multistate No.
(N/A)
Program Code
FARAD
Project Start Date
Aug 1, 2014
Project End Date
Jul 31, 2016
Grant Year
2014
Project Director
Vickroy, T. W.
Recipient Organization
UNIVERSITY OF FLORIDA
G022 MCCARTY HALL
GAINESVILLE,FL 32611
Performing Department
Physiological Sciences VM-PHY
Non Technical Summary
This proposal is to fund the continued implementation and further expansion of the Food Animal Residue Avoidance Databank or FARAD program at the University of Florida. FARAD was launched as an independent program in 1982 and currently is a collaborative consortium of colleges of veterinary medicine at North Carolina State University (NCSU), the University of California Davis (UCD) the University of Florida (UF) and Kansas State University (KSU). FARAD developed from the Residue Avoidance Program (RAP) as a repository of residue avoidance information and educational materials related to regulated drugs and other chemicals in food-producing animal species. Throughout most of the program's existence, FARAD has been funded by USDA/CSREES and more recently by USDA/NIFA. The overarching goal of FARAD is to protect the integrity of and facilitate production of safe foods of animal origin through the development and dissemination of scientific information that can be used to prevent or mitigate risks posed by violative residues of chemical agents (drugs, pesticides, environmental contaminants, etc.) in food animal products. While the principal users of FARAD are veterinarians, regulatory agency employees and extension specialists, the ultimate client is the general public who can consume foods of animal origin that are free of harmful drug or chemical residues. In its present-day format, FARAD is an expert-mediated residue avoidance decision support system that provides timely advice as well as real-time web-based information on a wide range of drugs and chemical entities. The FARAD program is considered pivotal for execution of regulations promulgated under the Animal Medicinal Drug Use Clarification Act of 1994 (AMDUCA) that provide a legal framework for the extra-label use of drugs in food-producing animal species by veterinarians. AMDUCA regulations require that extra-label use of drugs in food animals be based on sound principles of residue avoidance. The National Research Council acknowledged FARAD as the primary source of this information.
Animal Health Component
60%
Research Effort Categories
Basic
30%
Applied
40%
Developmental
30%
Classification

Knowledge Area (KA)Subject of Investigation (SOI)Field of Science (FOS)Percent
71133101180100%
Goals / Objectives
The elemental goal of FARAD is the production of safe foods of animal origin through the prevention and mitigation of violative chemical (drug, pesticide, natural toxins, and environmental contaminant) residues in food animal products. It accomplishes this through its objectives which are to identify, extract, assemble, evaluate and distribute reviewed information about residue avoidance and mitigation to people involved in residue avoidance programs throughout the United States. 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. With implementation of cooperating international residue programs through Global FARAD [gFARAD], those data are available for evaluation and dissemination.
Project Methods
The primary focus for the University of Florida component of FARAD for 2014-2015 will involve the following methods to achieve our objectives:• continued updating and expansion of electronic information resources that are freely available to veterinarians, producers, regulators and other individuals involved in food animal production industries. These resources include the main FARAD web site (www.farad.org), the Veterinarian's Guide to Residue Avoidance Management (VetGRAM), a Withdrawal Interval (WDI) lookup tool for published estimates of safe WDI values for extralabel uses of selected drugs in selected species as well as a recently-launched mobile app version of VetGRAM;• continue to conduct weekly reviews of Federal Register notices related to animal drug regulations and to incorporate relevant changes in regulations in our searchable USADDS databases, including new drug approvals, changes in approved food animal drug uses, changes in drug residue tolerances and updates in approved drug withdrawal times;• continue to collaborate with FARAD investigators at UC Davis NCSU and KSU to revise and validate computational estimates for safe withdrawal intervals for drugs that are commonly used off label in food animals.• further development and release of applications for use on smartphones and mobile devices that will allow more extensive access to FARAD website applications, including VetGRAM, Withdrawal Date Calculator and other on-line interfaces.

Progress 08/01/14 to 07/31/16

Outputs
Target Audience:The target audience for FARAD includes veterinarians, extension specialists, government and industry regulators as well as producers throughout all parts of the food animal industries. Veterinarians may submit questions for expert-mediated consultations by FARAD via a nationwide toll-free hotline (1-888-USFARAD or 1-888-873-2723) or through a Web-based online submission portal. The databank, which is updated and maintained regularly, is readily searchable and allows for curated information to be accessed and considered by trained FARAD experts who provide guidance in response to inquiries from veterinarians about potential residue problems associated with situations involving contaminant exposure or legal extralabel drug therapy in food-producing animals. Changes/Problems: Nothing Reported What opportunities for training and professional development has the project provided? Nothing Reported How have the results been disseminated to communities of interest?See above for detailed information onweb-based platforms and smartphone apps What do you plan to do during the next reporting period to accomplish the goals? Nothing Reported

Impacts
What was accomplished under these goals? A. A major programmaticaccomplishment of FARAD was the collection, updating and dissemination of regulatory information pertaining to FDA-approved animal drugs. The FARAD center at UF is responsible for collecting and entering data for the US Approved Animal Drugs Database (US-AADD), maintaining and updating the publicly-accessible FARAD website (www.farad.org) as well as development and maintenance of associated web-based interactive databases and mobile platforms, including the Veterinarian's Guide to Residue Avoidance Management (VetGRAM) and apps for smartphones and other mobile devices. These FARAD products provide complete information about approved animal drugs, including dosing information, disease indications, species and use-class restrictions as well as the associated withholding times for meat, milk, eggs, honey and other products following label?approved drug treatments. A calendar function has been integrated into these programs to aid veterinarians in the determination of proper withholding times and dates following drug treatments that are consistent with approved regulations. All of this information is openly accessible and free of charge to users who seek information about labeled uses of food animal drugs. As an addendum, it is worthwhile to note that within the drug approval process, estimations for safe withdrawal times are based upon determinations in healthy animals. However, for certain drugs and/or certain disease states, it has been discovered that drug disposition may be altered by the disease or abnormal condition, especially in situations where drug metabolism is involved. In view of these specific situations that are now recognized as well as the likelihood of additional situations that are still unrecognized, it may not always be safe to assume that use of an approved drug in accordance with label instructions will be sufficient to avoid violative residues. B. Based on usage patterns as described above, the FARAD web site (www.farad.org) continued to be a highly-used resource for domestic and international users. Our fully searchable databases were accessed by more than 1000 users each week by the end of the report period and the annual growth in this usecontinued at double digit percentages year over year. Every week, the UF component of FARAD conducted detailed reviews of the Federal Register to extract the latest information pertaining to drug approvals in food animal species, both major (cattle, pigs, turkeys and chickens) and minor (goats, sheep, game birds, bison, etc.) species. During the 2016 calendar year, more than 2,000 revisions were incorporated into the FARAD databases in response to newly released or updated regulatory information as well as newlypublished research reports. C. Workcontinued on the development of web pages for several minor use species, such as sheep and gamebird industries. D. Our program's first mobile app was developed and launched in 2013 and a second major new app for use on iPhones was released in 2015. One significant advantage of these apps is that all data and resources are "native" insofar as data is fully accessible and usable even in the absence of internet access to other live mobile platforms. New products are currently under development with the goal to increase accessibility by smartphones to a up-to-date and complete drug residue information. An increasing number of smartphone app installs have been made on devices associated with foreign-based wireless carriers, including Australia, Bolivia, Canada, China, Germany, Great Britain, Hungary, Italy, Mexico, Netherlands, New Zealand and the Philippines.

Publications

  • Type: Journal Articles Status: Published Year Published: 2104 Citation: Baynes RE, Riviere JE (eds): Strategies for Reducing Drug and Chemical Residues in Food Animals: International Approaches to Residue Avoidance, Management and Testing. New York: Wiley, 2014. Li M, Gehring R, Tell L, Baynes R, Huang Q, Riviere JE: Interspecies mixed effect pharmacokinetic modeling of penicillin G in cattle and swine. Antimicrob. Agents Chemother. 58: 4495-4503, 2014. [24867969] Huang Q, Riviere JE: The application of allometric scaling principles to predict pharmacokinetic parameters across species. Expert Opinion Drug Metab. Toxicol. 10: 1241-1253, 2014. [24984569] Kissel LW, Leavens TL, Baynes RE, Riviere JE, Smith G. Comparison of flunixin pharmacokinetics and milk elimination in healthy cows and cows with mastitis. J.Am.Vet.Med.Assoc. 246: 118-125, 2015 [25517334]