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
COMPLETE
Funding Source
Reporting Frequency
Annual
Accession No.
0225781
Grant No.
2011-41480-30558
Cumulative Award Amt.
$190,080.00
Proposal No.
2011-03491
Multistate No.
(N/A)
Project Start Date
Aug 15, 2011
Project End Date
Aug 14, 2014
Grant Year
2011
Program Code
[FARAD]- Food An. Res. Avoidance Database,FARAD
Project Director
Vickroy, T. W.
Recipient Organization
UNIVERSITY OF FLORIDA
G022 MCCARTY HALL
GAINESVILLE,FL 32611
Performing Department
College of Veterinary Medicine
Non Technical Summary
The Food Animal Residue Avoidance Databank (FARAD), which has existed since 1982 and is funded by USDA/CSREES, is a collaborative project among colleges of veterinary medicine at North Carolina State University [NCSU], the University of California at Davis [UCD] and the University of Florida [UFL]. The overarching goal of FARAD is to protect the integrity of and maintain production of safe foods of animal origin through the prevention and mitigation of violative chemical residues in food animal products. 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. FARAD originated with the Residue Avoidance Program (RAP) in 1982 as a repository of residue avoidance information and educational materials. FARAD has now evolved into an expert-mediated residue avoidance decision support system, which provides timely advice and information on a wide range of drug and chemical entities. This ability has proved vital to the execution of the Animal Medicinal Drug Use Clarification Act of 1994 (AMDUCA) regulations that legalized the extralabel use of drugs by veterinarians. AMDUCA regulations require that extralabel 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
35%
Research Effort Categories
Basic
65%
Applied
35%
Developmental
(N/A)
Classification

Knowledge Area (KA)Subject of Investigation (SOI)Field of Science (FOS)Percent
7113220118010%
7113230118010%
7113310118030%
7113410118040%
7113510118010%
Goals / Objectives
FARAD is a USDA/NIFA-sponsored program that originated with the Residue Avoidance Program in 1982. Today, it is a collaboration of North Carolina State University, University of California-Davis and the University of Florida that has become crucial to the maintenance of a residue-free food supply to the American public. It is important to recognize that FARAD works with residues that can be from either drugs used in veterinary practice, agricultural chemicals or outright environmental contaminants. It is unfortunate but livestock could be exposed to the latter as a consequence of agro-terrorism and, in the event of such an occurrence, expertise within FARAD would be key to mitigation of exposure risk. FARAD functions through the collection of a variety of data and their application in formulating recommendations to its clients to avoid or mitigate residues. This process can involve the use of simple mathematical extrapolation 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. FARAD personnel search the scientific literature for information about the elimination of chemicals from food producing animals, extract this information when it is relevant, and enter it into a computer data bank for easy retrieval. Because there are many factors which can affect how fast an animal eliminates a residue; information about diet, age, sex, breed, and disease are all taken into consideration. The data bank allows existing information to be rapidly brought to bear on accidental residue problems arising from exposure to environmental contaminants or to advise veterinarians on avoiding potential residues from extra-label drug therapy. 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 or gFARAD, those data are also available for evaluation and dissemination. FARAD was authorized by the Agricultural Research, Extension, and Education Reform Act of 1998 (AREERA).
Project Methods
The University of Florida component has continued data collection and entry for the US Approved Animal Drugs Database (US-AADD). A shift by the Food and Drug Administration to limit data release in the Federal Register has resulted in the incorporating of more information in the Freedom of Information (FOI) summary of the approval packet. While this provides more information for incorporation into US-AADD it is at the expense of involving more labor intensive extraction. The major change in the database structure with integration of tolerance data through use of Chemical Abstract Services (CAS) numbers has been completed. This was a major change in the database as it allowed cross referencing active ingredients without regard to NADA. A subset of CAS numbers was used to allow the EWE algorithm automatic access to tolerance data while maintaining the ability to link gFARAD databases independent of languages. A new species coding is now under development to make possible easier integration of the various gFARAD databases and simplify handling FDA approved drug data. VetGRAM has been mounted on the FARAD server at NCSU for nearly 3 years without problems. During that time it has proven robust and attracted widespread support. Similarly the NRSP-7 website database of drugs approved for minor species (MUMSRx) has been maintained.

Progress 08/15/11 to 08/14/14

Outputs
Target Audience: The target audeince for the FARAD program and associated FARAD websites and electronic databases are veterinarians, especially those involved with treatment and care of food-producing animals, food animal producers, state and federal regulators and individuals involved with food safety. 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? The results have been disseminated through both electronic and print means, including the FARAD website, a new VetGRAM mobile app for android phones, a mobile device-friendly website, and poster presentions at national veterinary meetings. What do you plan to do during the next reporting period to accomplish the goals? Nothing Reported

Impacts
What was accomplished under these goals? Information related to chemical residues in food-producing animals was collected from a variety of resources, analyzed and entered into FARAD databases for on-line access. The major accomplishments by the University of Florida component of FARAD included the following:(1) 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 amobile applicationof VetGRAM for use on Android smartphones; (2) weekly reviews of Federal Register notices relevant to animal drug regulations and incorporation of important 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;and (3) continued collaboration 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. Specific accomplishments included: (1) Revision and Expansion of Electronic Information Resources: Following our major revision and expansion of on-line information resources, usage of these resources has remained at a very high level. Based on usage patterns as determined through Google Analytics (Fig. 1) plus feedback from veterinary practitioners who routinely use our on-line resources, the restructuring of our main web site (www.farad.org) that provided users with direct access to searchable databases has been highly successful. During the 24-month period from June of 2012 through June of 2014, web site visits averagedmore than 500visitors per week or more than 13,200 per annum. While the vast majority of visitors originated from the United States (approximately three-fourths), the FARAD website was accessed from individuals or groups located in more than 130 countries with the largest number of non-U.S. visitors originating from Canada, Philippines, Germany, India and Taiwan.In addition, the re-design of VetGRAM to allow for user-selected searches through the USADDS databases of food animal drug approvals and regulations has also lead to increased use of this resource. On-line users are now able to search the databases using self-selected criteria, including species and animal use class, drug classification, therapeutic use indication, route of administration or other selected search strategies. The search engine allows veterinarians to quickly identify those drugs that are best suited to each individual animal and to obtain the most up-to-date regulations regarding use of those agents in food animals. In conjunction with these revisions in VetGRAM, tha UF component of FARAD worked to develop and recently launched a free mobile app version of VetGRAM that is designed to work on phones and mobile devices that use the Android operating system. It is too early to know what level of usage or the nature of improvements that will be needed to support and update this new mobile app. (2) Continued Updates of FARAD Databases with Relevant Regulatory Information: 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. This process of information extraction and database updates was performed throughout the duration of the project in order to maintain the accuracy and currency of our on-line database resources. Usage statistics for our on-line resources indicates 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. Critical changes are announced through our on-line news updates and are also sent to followers via Twitter. (3) Expansion and Validation of Computational Estimates for Inclusion in On-Line WDI Lookup Tool: The UF component of FARAD developed and launched the WDI Lookup Tool several years ago as a way to provide drug withdrawal interval recommendations for selected approved drugs that are commonly used in an extra-label manner that may involve a different route of administration, altered dose regimen, or some other variance from approved label instructions. Usage of this on-line resource has grown remarkably and we continue to expand this database. In collaboration with the other FARAD sites, we developed and used physiologically-based pharmacokinetic (PBPK) models and population-based modeling to develop and validate better estimates for drug residue depletion rates in major and minor food animal species.

Publications


    Progress 08/15/13 to 08/14/14

    Outputs
    Target Audience: Veterinarians, Food Animal Producers, U.S. Government Regulators, Foreign Government Regulators 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? Results have been disseminated through many of the electronic avenues described above, including the program's websites and newly launched mobile app. In addition, a presentation was given at a national veterninary conference. What do you plan to do during the next reporting period to accomplish the goals? Continue to work on the goals listed above.

    Impacts
    What was accomplished under these goals? (1) Revision and Expansion of Electronic Information Resources: On-line information resources were updated and expanded to include the latest regulations pertaining to drugs that are used in food-producing animal species, including both major and minor species. Use of these electronic resources has remained at a very high levelas determined through Google Analytics-based tracking plus feedback from veterinary practitioners who routinely use our on-line resources.The continuing expansion and restructuring of our main web site (www.farad.org) that provides users with direct access to searchable databases has led to continued growth in our web traffic. During theperiod from March of 2013 through March of 2014, web site visits averaged 530 visitors per week or more than 27,500 total visitors. While the vast majority of visitors continued to originate from the United States (74%), the FARAD website was accessed from 124 countries worldwide with the largest number of non-U.S. visitors originating from Canada, Philippines, Germany, India and Taiwan.The re-designed version of VetGRAM, which allows foruser-selected searches through the USADDS databases of food-animal drug approvals and regulations has also lead to increased use of this resource. On-line users are now able to search the databases using self-selected criteria, including species and animal use class, drug classification, therapeutic use indication, route of administration or other selected search strategies. The search engine allows veterinarians to quickly identify those drugs that are best suited to each individual animal and to obtain the most up-to-date regulations regarding use of those agents in food animals. In conjunction with these revisions in VetGRAM, the release of a free mobile app version of VetGRAM that is designed to work on phones and mobile devices that use the Android operating system has been extremely succesful in the inaugural year. (2) 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. This process of information extraction and database updates will be continued throughout the upcoming year in order to maintain the accuracy and currency of our 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. Critical changes are announced through our on-line news updates and are also sent to followers via Twitter. (3) Expand and Validate Computational Estimates for Inclusion in On-Line WDI Lookup Tool: The UF component of FARAD developed and launched the WDI Lookup Tool several years ago as a way to provide drug withdrawal interval recommendations for selected approved drugs that are commonly used in an extra-label manner that may involve a different route of administration, altered dose regimen, or some other variance from approved label instructions. Usage of this on-line resource has grown remarkably and we continue to expand this database. In collaboration with the other FARAD sites, we will continue to develop and use physiologically-based pharmacokinetic (PBPK) models and population-based modeling to develop and validate better estimates for drug residue depletion rates in major and minor food animal species. Our focus will continue to involve those drugs that are responsible for the highest proportion of violations in surveillance studies by governmental regulatory agencies. Further details of these planned efforts are outlined in the work plans for the other FARAD regions.

    Publications

    • Type: Websites Status: Published Year Published: 2013 Citation: www.farad.org


    Progress 08/15/12 to 08/14/13

    Outputs
    Target Audience: The target audience includes food animal vetrinarians, producers, governmental regulators and individuals in private industries that are associated in some manner with food-producing animals or products derived from same. 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? Results have been disseminated through continued updates of our on-line databases and through a newly launched mobile app and mobile-friendly web site. What do you plan to do during the next reporting period to accomplish the goals? This is the final report period and we are awaiting funding for program continuation.

    Impacts
    What was accomplished under these goals? Based on usage metrics, our main comprehensive and re-structured web site (www.farad.org), has been maintained and updatedto provide veterinarians, producers and others with full and direct access to the most frequently used information resources for approved drugs in food-producing animal species. In addition, the re-design of VetGRAM (www.farad.org/vetgram/Search.asp) is complete and allows users to select criteria for searches through our databases of food-animal drug approvals and regulations. Usage statistics for our on-line resources demonstrate continuedheavyuse of FARAD web-based resources, which reflects the high confidence among practitioners and other users in the accuracy of our databases. The launch of our mobile-device friendly version of VetGRAM has resulted in more than 200 users per week (average). Additional tools that are approaching final release will further increase use of our electronic resources by veterinarians, producers and government regulators. It is impossible to quantify measures of the impact of these resources on the incidence of violative chemical residues in various animal-derived human foods, but the likely impact is substantial. In the absence of funding of these activities by the US Department of Agriculture, these programmatic outcomes would not have been achieved.

    Publications

    • Type: Websites Status: Published Year Published: 2013 Citation: www.farad.org and associated web pages
    • Type: Other Status: Awaiting Publication Year Published: 2013 Citation: android phone mobile app is about to be uploaded in the google app store


    Progress 08/15/11 to 08/14/12

    Outputs
    OUTPUTS: FARAD is a USDA-sponsored program that is a collaborative research and extension program overseen by faculty in the colleges of veterinary medicine at North Carolina State University, University of California-Davis, University of Florida and Kansas State University. This program is an important component of the national effort to maintain a residue-free food supply for the American public. Outputs for the Florida component of FARAD this year included an on-going re-design and expansion of information services, including the main FARAD web site, VetGRAM web site and the on-line drug Withdrawal Interval (WDI) lookup tool; (2) on-going updates of searchable databases with relevant information continue to perform weekly reviews of Federal Register notices related to animal drug regulations and to incorporate relevant changes in regulations in our searchable databases, including new drug approvals, changes in approved food animal drug uses, changes in drug residue tolerances and updates in approved drug withdrawal times; and (3) continue to collaborate with FARAD investigators at UC Davis NCSU and KSU to develop and validate computational estimates of a safe withdrawal intervals for drugs that are commonly used off label in food animals. 1) Re-Design and Expansion of Information Resources: During the report period, UF undertook a major revision and expansion of on-line information resources in order to meet the changing needs of food-animal veterinarians, livestock producers and others who routinely use our resources. In conjunction with these revisions in VetGRAM, UF investigators have been working with a third-party vendor to develop a mobile phone application that will provide all of the capabilities offered through VetGRAM. We anticipate initial launch of this mobile app product in late 2012 or early 2013. 2) Continued Updates of FARAD Databases with Relevant Regulatory Information: Every week, UF workers conduct 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. This process of information extraction and database updates will be continued throughout the upcoming year in order to maintain the accuracy and currency of our on-line database resources. Usage statistics for our on-line resources demonstrate the heavy and growing use of FARAD resources, which reflects the high confidence among practitioners and other users in the accuracy of our databases. 3) Expand and Validate Computational Estimates for Inclusion in On-Line WDI Lookup Tool: The UF component of FARAD developed and launched the WDI Lookup Tool almost two years ago as a way to provide drug withdrawal interval recommendations for several approved drugs that are commonly used in an extra-label manner (different route of administration, dose regimen, etc.) in food animals. Usage of this on-line resource has grown remarkably and we continue to expand this database. PARTICIPANTS: Nothing significant to report during this reporting period. TARGET AUDIENCES: Nothing significant to report during this reporting period. PROJECT MODIFICATIONS: Nothing significant to report during this reporting period.

    Impacts
    Based on usage patterns and feedback from veterinary practitioners who routinely use our resources (more than 10,000 hits per year), our main web site (www.farad.org), has been re-structured to provide direct access to the most frequently used resources. In addition, VetGRAM (www.farad.org/vetgram/Search.asp) is being redesigned to allow for user-selected searches through our databases of food-animal drug approvals and regulations. Usage statistics for our on-line resources demonstrate the heavy and growing use of FARAD resources, which reflects the high confidence among practitioners and other users in the accuracy of our databases. The launch of our mobile-device friendly version of VetGRAM has resulted in more than 200 users per week (average) during the initial trial period. Additional tools that are approaching final release will further increase use of our electronic resources by veterinarians, producers and government regulators. It is impossible to quantify measures of the impact of these resources on the incidence of violative chemical residues in various animal-derived human foods, but the likely impact is substantial. In the absence of funding of these activities by the US Department of Agriculture, these programmatic outcomes would not have been achieved.

    Publications

    • No publications reported this period