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.
0230963
Grant No.
2012-41480-20118
Project No.
FLA-VME-005194
Proposal No.
2012-03562
Multistate No.
(N/A)
Program Code
FARAD
Project Start Date
Sep 1, 2012
Project End Date
Aug 31, 2015
Grant Year
2012
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
(N/A)
Research Effort Categories
Basic
25%
Applied
75%
Developmental
(N/A)
Classification

Knowledge Area (KA)Subject of Investigation (SOI)Field of Science (FOS)Percent
3143260118010%
3143320118010%
3143440118010%
3143450118010%
7113260118015%
7113320118015%
7113440118015%
7113450118015%
Goals / Objectives
The primary focus for the University of Florida component of FARAD is three-fold: (1) complete the re-design and expansion of information services that are freely available in various electronic formats, including the main FARAD web site, the VetGRAM (Veterinarian's Guide to Residue Avoidance Management) web site and the on-line drug Withdrawal Interval (WDI) lookup tool; (2) 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) During the past year, 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. 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 will be redesigned to allow for user-selected searches of food-animal drug approvals and regulations. This search engine will allow 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, UF has been working to develop a native mobile phone application that will provide all of the capabilities offered through VetGRAM. Once completed, the mobile app will be made available free to users and will be designed as a native android app to provide practitioners with complete access to up-to-date information on all approved food animal drugs in a readily searchable format. We anticipate initial launch of this mobile app product in late 2012 or early 2013. (2) 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. Usage statistics for our on-line resources demonstrate heavy and growing use of FARAD resources. (3) The WDI Lookup Tool was developed 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.
Project Methods
The University of Florida component of FARAD will continue to collect relevant drug approval information from the Federal Register and other sources for entry into the US Approved Animal Drugs Database (US-AADD). A shift by the Food and Drug Administration (FDA) to limit or reduce data release in the Federal Register has resulted in the incorporation of more information in the Freedom of Information (FOI) summaries for the drug product approval packet. While this provides more detailed information for incorporation into US-AADD, the process of data extraction has become a more labor intensive and requires greater mahnpower to carry out. 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 or ANADA numbers. 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 09/01/14 to 08/31/15

Outputs
Target Audience:Veterinarians, Private & Commercial Food Animal Producers, U.S. Government Regulators, Foreign Government Regulators, Educators 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?Our live updated databases are disseminated through multiple electronic avenues, including the program's websites, mobile-friendly platforms and a mobile app for smartphones. In addition, presentations pertaining to food animal drugs in the U.S. have been delivered at national and international conferences. What do you plan to do during the next reporting period to accomplish the goals?Continue to work on our stated program goals.

Impacts
What was accomplished under these goals? 1) Weekly 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. 2) Updated Date Entry into 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 food-producing animal species. Use of these electronic resources has remained at a very high level as determined through Google Analytics based tracking plus feedback from veterinary practitioners who routinely use our on-line resources. The continuing expansion and of our web site (www.farad.org) that provides users with direct access to searchable databases has led to continued growth in our web traffic. During the period from April 1, 2014 - March 31, 2015, web site visits averaged 582 visitors per week or more than 30,000 total visitors. While more than three-fourths (76%) of visitors originated from the United States, the FARAD website was accessed from 118 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 for user-selected searches through the USADDS databases of food-animal drug approvals and regulations has also led 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. (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 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


    Progress 09/01/12 to 08/31/15

    Outputs
    Target Audience:The primary target audience for this program are veterinarians who treat food-producing animal species, producer groups, government regulators (both domestic and international) and educators who train veterinarians. 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?Our live updated databases are disseminated through multiple electronic avenues, including the program's websites, mobilefriendly platforms and a mobile app for smartphones. In addition, presentations pertaining to food animal drugs in the U.S. have been delivered at national and international conferences. What do you plan to do during the next reporting period to accomplish the goals?Nothing since this is a final report for this project.

    Impacts
    What was accomplished under these goals? 1) Weekly 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. 2) Updated Date Entry into 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 food-producing animal species. Use of these electronic resources has remained at a very high level as determined through Google Analytics based tracking plus feedback from veterinary practitioners who routinely use our on-line resources. The continuing expansion and of our web site (www.farad.org) that provides users with direct access to searchable databases has led to continued growth in our web traffic. During the period from April 1, 2014 - March 31, 2015, web site visits averaged 582 visitors per week or more than 30,000 total visitors. While more than three-fourths (76%) of visitors originated from the United States, the FARAD website was accessed from 118 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 for user-selected searches through the USADDS databases of food-animal drug approvals and regulations has also led 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. (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 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: 2012 Citation: n/a (see individual web sites listed in progress reports)


    Progress 09/01/13 to 08/31/14

    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 level as 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 the period 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 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, 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 09/01/12 to 08/31/13

    Outputs
    Target Audience: Veterinarians, Food Animal Producers, 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: 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 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 nine-month period from June of 2012 through March of 2013, web site visits averaged 489 visitors per week or more than 17,600 total visitors. While the vast majority of visitors originated from the United States (73.6%), the FARAD website was accessed from 124 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) 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: 2012 Citation: http://www.farad.org http://www.farad.org/vetgram/search.asp http://www.farad.org/WDIlookup/