Performing Department
(N/A)
Non Technical Summary
The Food Animal Residue Avoidance Databank (FARAD) is a national food safety program that is supported by the National Institute for Food and Agriculture (NIFA) in the United States Department of Agriculture (USDA). FARAD developed from the Residue Avoidance Program and was established in 1982. During the current application cycle, FARAD will have been in operation nearly continuously for 35 years. In its current configuration, FARAD is a collaborative program that is organized and run by faculty at four U.S.-based colleges/ schools of veterinary medicine, including North Carolina State University (NCSU), the University of California-Davis (UCD), the University of Florida (UF) and Kansas State University (KSU). FARAD has become an important resource that provides up-to-date regulatory information and serves as a real-time drug advisory resource for veterinarians, producers and others involved in food animal production industries. As such, FARAD is an important and crucial program for the protection and maintenance of a residue-free food supply for the American public.The central mission of FARAD is to collect, analyze and generate scientifically-based pharmacometric information and to use this and other regulatory information to provide timely, scientifically-based recommendations to veterinarians, producers, industry representatives and others involved in food animal production. The benefits derived from FARAD are both proactive and reactive insofar as recommendations from FARAD can help prevent the accumulation of harmful drug residues in animal-derived food products as well as help to mitigate the impact from accidental exposures of food animals to agricultural chemicals, pesticides and industry-derived environmental contaminants, such as heavy metal contamination in cattle exposed to gas fracking water and radionuclide contamination of food animals. During the Fukushima nuclear reactor disaster several years ago in Japan, FARAD advised regulatory officials from the Japanese Ministry of Agriculture. In addition, FARAD provided safe estimates for food safety during the manmade melamine contamination crisis nearly 8 years ago. The comprehensive collection and sophisticated pharmacokinetic analyses of chemical residue depletion profiles in a variety of food-producing animal species positions FARAD to provide crucial withdrawal information during incidents that impact livestock, including natural disasters, industrial accidents and intentional acts of agro-terrorism. In such instances, FARAD's expertise for mitigation of health risks to humans represents a key part of disaster response.FARAD functions through the collection of a variety of data related to the depletion of drugs and chemicals in animal tissues and the application of these data in formulating recommendations to its clients to avoid or mitigate residues. This process can involve the use of simple mathematical extrapolations or novel complicated algorithms where no readily applicable data exists to predict chemical depletion. FARAD's immediate clients are practicing veterinarians, regulators and extension officers, but it ultimately protects the food consuming public and contributes to enhanced human public health by equipping these professionals with the best science available from our research.FARAD personnel at UCD search the scientific literature for information about chemical elimination from food producing animals, extract relevant information, and enter it into a computer databank for easy retrieval. Because there are many factors which affect how rapidly an animal eliminates a residue; information about diet, age, sex, breed, and disease are taken into consideration. The databank allows existing curated information to be efficiently brought to bear "real time" on residue problems arising from exposure to environmental contaminants or from extralabel drug therapy. FARAD at UF collects and makes available a compilation of FDA approved drugs from which approved withdrawal times can be obtained. These data are available on FARAD's web-based interactive database, the Veterinarian's Guide to Residue Avoidance Management (VetGRAM), found at www.FARAD.org as well as mobile platforms for smartphone access. These FARAD products provide information for users about drugs that are approved for treating animal diseases, and the associated withholding times for milk, eggs, honey and pre-slaughter withdrawal times for meat. A calendar function is integrated into these programs to aid the veterinarian in the field. When information is not sufficient, direct access to FARAD experts is available through the Regional Access Centers at KSU, NCSU and UCD. FARAD provides multilayered service to persons most critical to production of safe foods of animal origin.FARAD is readily accessible through websites, e-mail, mobile applications and a toll-free telephone hotline, as well as in specific residue-avoidance publications. FARAD provides this guidance through use of its databank by specially trained doctoral-level professional staff to provide information on prevention and mitigation of violative chemical residues and supplies recommended withdrawal intervals to allow safe extralabel use of drugs in food animals under AMDUCA guidelines based on sound principles of residue avoidance. FARAD is a unique provider of such services. Expert system software that used to supplement printed compendia to helped drug users make more informed decisions, had been developed and are now available in a single portal, VetGRAM, available at FARAD's website maintained at UF. The development of pharmacokinetic strategies to link the chemical depletion data from the literature to the drug safety data from the drug approvals or regulatory authorities are conducted at KSU. The goal is to provide the best estimate of withdrawal time possible for the specific extra-label drug use or contaminant scenario at hand. Since residue data continues to be published daily in scientific journals and regulatory reports, maintenance and addition of new data by UCD are essential to providing accurate advice and mitigation of potential residue exposures. This is especially important since residue depletion data in food animals is sparse and FARAD predictions would be significantly strengthened with additional field data under usage conditions (e.g. in diseased animals for which the drug is labeled).FARAD has maintained a toll-free number since 1996: 1-888-US-FARAD to respond to specific inquiries for assistance. The primary FARAD website (www.farad.org) provides users with additional residue avoidance resources which reduce the need for more specialized and intensive telephone consultations. Over the past 17 years, with encouragement from the American Veterinary Medical Association (AVMA), the FARAD Digest series have been published in the Journal of the American Veterinary Medical Association (JAVMA) . These digests provide well-documented information about extralabel drug withdrawal intervals. FARAD is officially allied with the Centre for Applied Biosciences International's (CABI) since 2003 where FARAD files are included in the various issues of their Animal Health and Production Compendium. Last year, FARAD and CABI successfully were awarded a planning grant from the World Trade Organization Standards and Trade Development Facility (STDF) to assess feasibility of creating a global veterinary drug residue avoidance service, a FARAD goal for the last two decades.
Animal Health Component
80%
Research Effort Categories
Basic
0%
Applied
80%
Developmental
20%
Goals / Objectives
During the 2016-2017 FARAD project year, the UF-based component of FARAD will focus on maintaining our core programmatic missions and fulfilling the essential tasks, including assimilating and entering new regulatory data into the proprietary US-Approved Animal Drugs Database (US-AADD), maintaining all webpages and internet websites for FARAD and the expanding species-specific webpage resources, continued support and upgrading of platforms for mobile devices to access the Veterinarian's Guide to Residue Avoidance Management (VetGRAM) and other mobile-friendly applications, and distribution of electronic alerts and updates via email, Twitter and other electronic formats. The UF component work plan established for the upcoming project year has the following components:A. Continued Updating, Revision and Expansion of Electronic Information Resources: Based on usage patterns as determined through Google Analytics (see above) and other survey instruments, the restructured web site (www.farad.org) to provide domestic and international users direct access to searchable databases has been highly successful. During the 2015 calendar year, there were more than unique 50,000 visitors to the FARAD website (average of 138 daily visits), which corresponds to a 23.5% increase over the previous year. Updates are provided in a timely manner and coincide with changes announced through the Federal Register.B. Continue Updates of FARAD Databases with Relevant Regulatory Information: Every week, the UF component of FARAD conducts 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 2015 calendar year, more than 1,600 revisions were incorporated into the FARAD databases in response to newly released or updated regulatory information as well as newly-published research reports. This process of information extraction and database updates will be continued throughout the upcoming year in order to maintain the accuracy and currency of all on-line database resources. Usage statistics for our on-line resources indicate a continued and high volume of use of FARAD resources, which reflects the high confidence among practitioners and other users in the accuracy and completeness of our databases.C. Expand Development of Species-Specific Web Pages: During the past year, several new web pages were launched that were targeted toward veterinarians and producers with specific interests in dairy cattle and swine. These more focused pages have been an outgrowth from requests for information that is focused and complete for particular groups of users. Work will continue in this area and may include development of pages for several minor use species, such as sheep and gamebird industries.D. Continue Development of Smartphone Mobile Apps and Expand Database and Resource Accessibility for Mobile Devices: Our program's first mobile app was developed and launched three years ago and a second major new app for use on iPhones was released within the past several months. 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. Informal feedback from food animal veterinarians has affirmed the utility of this capability since practitioners frequently encounter gaps in wireless or internet accessibility. Several new products are currently under development for android-based and Apple smartphones with the goal to further expand the utility of smartphones for accessing up-to-date and complete drug residue information. While more than 90% of the smartphone APP installs have been made on devices with US-based wireless carriers, a growing number of installs have been downloaded onto devices that are associated with foreign-based wireless carriers, including Australia, Bolivia, Canada, China, Germany, Great Britain, Hungary, Italy, Mexico, Netherlands, New Zealand and the Philippines.
Project Methods
The general approach or ways in which the project will be carried out is based on a shared and inter-dependent approach by the four collaborating universities. Program functions are split among the four centers in order to provide comprehensive support of the national program. The regional splits are generally along the following lines:Kansas State University (KSU) -Coordinate national program, develop pharmacokinetic modeling approaches and provide pharmacokinetic support to FARAD components, and on a rotating schedule with NCSU and UCD, provide responses to emergency queries from the FARAD Hotline.The University of California (UCD) - maintains the pharmacokinetic, bibliographic and call center databases and web-based access to the kinetic and bibliographic citation files. On a rotating basis with NCSU and KSU, UCD provides responses to drug and contaminant residue questions.The University of Florida (UF)- Collects and enters data for the US Approved Animal Drugs Database (US-AADD), maintains internet websites for FARAD, creates and supports platforms for mobile devices to access the Veterinarian's Guide to Residue Avoidance Management (VetGRAM) and other mobile-friendly applications, and distributes electronic alerts and updates via email, Twitter and other electronic formats.North Carolina State University (NCSU)- On a rotating schedule with UCD and KSU, provides responses to emergency telephone calls from the FARAD hotline.Collaboration between all institutions occurs on research projects that are necessary to validate the FARAD withdrawal interval estimates, and on the development of the global FARAD resource. The five primary methods of approach are: (1). Extraction and validation of data for incorporation into the system and support for FARAD's approved drug databases for publication in electronic format (VetGRAM) for internet delivery. This includes extraction of relevant data from foreign drug compendia and gFARAD partners; (2). Operation of the Regional Access Centers (RAC's) at KSU, NCSU and UCD for provision of residue avoidance information, with access through the toll-free hotline and e-mail; (3). Data entry, pharmacokinetic analysis, maintenance, and distribution of the FARAD files; (4). Preparation of FARAD Digests for publication in the Journal of the AVMA, Newsletters, FARAD Fact Sheets when appropriate for rapid dissemination of information in an ongoing crisis, and other publications for distribution; and (5). Develop and validate methods to allow extrapolative techniques to be used in providing advice in situations where no direct data exists, the norm for mitigating environmental contaminant exposures.