Source: UNIVERSITY OF CALIFORNIA, DAVIS submitted to
THE INCORPORATION OF DRUG TESTING METHODOLOGY DATA INTO THE FOOD ANIMAL RESIDUE AVOIDANCE DATABANK (FARAD)
Sponsoring Institution
National Institute of Food and Agriculture
Project Status
TERMINATED
Funding Source
Reporting Frequency
Annual
Accession No.
0211505
Grant No.
(N/A)
Project No.
CALV-AH-304
Proposal No.
(N/A)
Multistate No.
(N/A)
Program Code
(N/A)
Project Start Date
Apr 15, 2007
Project End Date
Apr 14, 2012
Grant Year
(N/A)
Project Director
Tell, LI, AN.
Recipient Organization
UNIVERSITY OF CALIFORNIA, DAVIS
410 MRAK HALL
DAVIS,CA 95616-8671
Performing Department
Medicine & Epidemology
Non Technical Summary
There is no database that summarizes information regarding drug testing methodologies for samples from food producing animals. The purpose of this project is to create a repository of data relative to existing antibiotic drug residue testing methodologies so that scientific data is available for evaluation of extra-label drug use in food animal species.
Animal Health Component
100%
Research Effort Categories
Basic
(N/A)
Applied
(N/A)
Developmental
(N/A)
Classification

Knowledge Area (KA)Subject of Investigation (SOI)Field of Science (FOS)Percent
7113399118020%
7113499118035%
7113599118010%
7113699118010%
7113799118010%
7113820118015%
Goals / Objectives
A. To review the scientific literature encompassing antimicrobial drug residue testing methodologies for samples that would be derived from food producing animals prior to processing or by products from food producing animals (i.e. milk, eggs, honey, etc). Scientific manuscripts with quality data will be added to the existing FARAD bibliographic database. B. To extract data from the scientific literature and create a searchable database that will provide information regarding testing methodologies for various matrices (i.e. milk, blood, urine) and antimicrobial drugs. This information will be used to make recommendations regarding sound testing methods that can be used to avoid drug residues. C. To identify gaps in the scientific literature for future research projects.
Project Methods
A. To review the scientific literature encompassing antimicrobial drug residue testing methodology. An extensive review of the scientific literature encompassing drug residue methodologies will be performed. This review will be led by a microbiologist with extensive food safety experience. Manuscripts that are considered to have quality scientific data will be entered into the existing FARAD database for utilization by all three collaborating universities that are involved with the FARAD program (UC Davis, North Carolina State University, and University of Florida) and global FARAD partners (Canada and China). B. To extract data from the scientific literature and create a searchable database. Data extraction from the scientific literature will entail characterizing assay systems by methodology, specific drug targets, and the appropriateness for utilization on various samples from multiple food animal species. When possible, assay characterization will include analytical sensitivity, specificity, and lower limit of detection on a sample by sample basis. These assay sensitivities will be compared to the maximum residue limits for specific drugs in specific tissues. All of this data will be entered into a newly established searchable database that FARAD personnel will use when advising veterinarians regarding extra label drug use in food producing animals. C. Identify scientific gaps leading to future studies that will evaluate drug residue assay tests. Identified gaps in the scientific literature, including potential extra label use of the drug testing systems (i.e. using a test that was developed for bovine milk to test caprine milk), will form the basis for future laboratory based scientific studies that will evaluate the clinical application of these test kit systems.

Progress 04/15/07 to 04/14/12

Outputs
OUTPUTS: The focus of this project was to review the scientific literature encompassing antimicrobial drug residue testing methodologies for samples that would be derived from food producing animals prior to processing or by products of those animals (i.e. milk, eggs, honey, etc), extract the data and create a database that would provide searchable scientific data relative to existing antibiotic drug residue testing assays so veterinarians/producers can be advised as to what assays to use to ensure that various food products are free of drug residues when veterinary products are used in an extralabel manner. The major output was to provide a service through the development of this new database and identify gaps in the scientific literature for future research projects. This review was led by a microbiologist with extensive food safety experience. Over the last 5 years, we reviewed the scientific literature encompassing drug residue methodologies and identified database fields for extraction of useful information. The mainframe and interface for the database was constructed. Key fields identified as important were manufacturer and website, active ingredient, species, matrix, lower limit of detection, maximum residue limits, potential violative results, analytical sensitivity/specificity, calculated field to quantitate false negative/positive results, kit/test validation, methodology, sample types studied and concentrations of drugs actually tested. Web URLs for kit information and updates were included. A link was created so that all tolerance data from another FARAD database could be linked with the commercial assay section of the database. A bibliographic section was created that is searchable by active ingredient, species/matrix to retrieve published information on extralabel use and performance of rapid assay test kits. At the end of this project, 64 commercial rapid assay tests were added and expanded to include 718 records encompassing 73 active ingredients, 12 animal species/groups, and 11 matrices. A search/review of manuscripts for the bibliographic section was evaluated to determine if they contained fully useful data (FUDs), maybe useful data (MUDs) or no useful data (NUDs) based on criteria established in Year 2. The Master Bibliographic Database for FARAD only accommodated manuscripts that contained pharmacokinetic data, this database was modified to accommodate the addition of the new manuscripts for the Rapid Assay Database. Data extraction/data entry into this section of the database was initiated. Manuscripts for the bibliographic section of the Rapid Assay Test Kits were obtained from Pubmed, Biosis, Chemical Abstracts, CAB Abstracts, AGRICOLA, Food Science and Technology Abstracts, Aquatic Sciences and Fisheries Abstracts, Wildlife and Ecology Studies Worldwide databases. Manuscripts that were identified for relevance from these searches were added to the bibliographic section of the Rapid Assay Database. A total of 1223 manuscripts were reviewed and 44 were identified as having FUD where as 1179 were identified as having NUD. Of the 44 manuscripts that had FUD, data extraction was performed on 35 of those manuscripts. PARTICIPANTS: This is a collaborative project between the Department of Population and Health and Reproduction and the University of California Davis component of FARAD and so depends on the coordination of a variety of individuals, including faculty members within the departments, a research microbiologist, veterinarian consultants, and computer programmers. It also involves the other two universities involved with the FARAD program, North Carolina State University and the University of Florida. TARGET AUDIENCES: The target audiences for this project primarily include food animal veterinary clinicians and various food animal producers. Veterinary clinicians have access to an already existing FARAD program to consult about the pharmacokinetics of drug usage and drug withdrawal intervals in various food animals. This project incorporates a new database of drug detection assays that will be of interest to the same audiences. PROJECT MODIFICATIONS: Nothing significant to report during this reporting period.

Impacts
The outcome of this project was that a database was created and used when analysts were helping to advise veterinarians about testing matrices after drugs were used in livestock in an extra-label manner. This enabled veterinary health professionals to avoid drug residues associated with animal derived food products from entering the human food chain.

Publications

  • No publications reported this period


Progress 01/01/11 to 12/31/11

Outputs
OUTPUTS: The focus during this year was to add data into the bibliographic section of the database. In addition, the commercial rapid assay tests section of the database was expanded upon. To date 64 commercial rapid assay tests have been added and expanded to include 718 records encompassing 73 active ingredients, 12 animal species/groups, and 11 matrices. A search and review of manuscripts for the bibliographic section of the database were evaluated to determine if they contained fully useful data (FUDs), maybe useful data (MUDs) or no useful data (NUDs) based on the criteria that was established in Year 2 of this project. The bibliographic section of the database was further tested and refined this year. This section is searchable by active ingredient, species and matrix to retrieve published information on extralabel use and performance of rapid assay test kits. Data extraction/data entry into this section of the database was initiated. A total of 553 records were evaluated, 122 records were extracted. 7 species categories are now represented and 6 matrices. PARTICIPANTS: This is a collaborative project between the Department of Population and Health and Reproduction and the University of California Davis component of FARAD and so depends on the coordination of a variety of individuals, including faculty members within the departments, a research microbiologist, veterinarian consultants, and computer programmers. It also involves the other two universities involved with the FARAD program, North Carolina State University and the University of Florida. TARGET AUDIENCES: The target audiences for this project primarily include food animal veterinary clinicians and various food animal producers. Veterinary clinicians have access to an already existing FARAD program to consult about the pharmacokinetics of drug usage and drug withdrawal intervals in various food animals. This project incorporates a new database of drug detection assays that will be of interest to the same audiences. PROJECT MODIFICATIONS: Nothing significant to report during this reporting period.

Impacts
Additional manuscripts for the bibliographic section of the Rapid Assay Test Database were added. Manuscripts were obtained from Pubmed, Biosis, Chemical Abstracts, CAB Abstracts, AGRICOLA, Food Science and Technology Abstracts, Aquatic Sciences and Fisheries Abstracts, Wildlife and Ecology Studies Worldwide databases and the data were extracted and added to the database. Adding information to the bibliographic section of the database will allow analysts to respond to extra label rapid assay kit related questions.

Publications

  • No publications reported this period


Progress 01/01/10 to 12/31/10

Outputs
OUTPUTS: The focus during this year was to add data into the commercial assay section of the database. To date 61 commercial rapid assay tests have been added and expanded to include 680 records encompassing 64 active ingredients, 11 animal species/groups, and 10 matrices. A search and review of manuscripts for the bibliographic section of the database were evaluated to determine if they contained fully useful data (FUDs), maybe useful data (MUDs) or no useful data (NUDs) based on the criteria that was established in Year 2 of this project. Since the current Master Bibliographic Database for FARAD only accommodated the manuscripts that contain pharmacokinetic data, the Master Bibliographic Database was modified to accommodate the addition of these new manuscripts for the Rapid Assay Database. Simultaneously, the bibliographic section was created. This section is searchable by active ingredient, species and matrix to retrieve published information on extralabel use and performance of rapid assay test kits. Data extraction/data entry into this section of the database was initiated. A total of 1223 manuscripts were reviewed and of those, 44 were identified as having fully useful data where as 1179 were identified as having no useful data. Of the 44 manuscripts that had fully useful data, data extraction was performed on 35 of those manuscripts. PARTICIPANTS: This is a collaborative project between the Department of Population and Health and Reproduction and the University of California Davis component of FARAD and so depends on the coordination of a variety of individuals, including faculty members within the departments, a research microbiologist, veterinarian consultants, and computer programmers. It also involves the other two universities involved with the FARAD program, North Carolina State University and the University of Florida. TARGET AUDIENCES: The target audiences for this project primarily include food animal veterinary clinicians and various food animal producers. Veterinary clinicians have access to an already existing FARAD program to consult about the pharmacokinetics of drug usage and drug withdrawal intervals in various food animals. This project incorporates a new database of drug detection assays that will be of interest to the same audiences. PROJECT MODIFICATIONS: Nothing significant to report during this reporting period.

Impacts
Manuscripts for the bibliographic section of the Rapid Assay Test Kits were obtained from Pubmed, Biosis, Chemical Abstracts, CAB Abstracts, AGRICOLA, Food Science and Technology Abstracts, Aquatic Sciences and Fisheries Abstracts, Wildlife and Ecology Studies Worldwide databases.

Publications

  • No publications reported this period


Progress 01/01/09 to 12/31/09

Outputs
OUTPUTS: This year the mainframe of the database was created. The database architecture includes: (1) Commercial rapid assay tests (allows the user to choose adding/editing or the search function); (2) Manufacturer information (allows the user to add, delete or change commercial assay test manufacturer information); (3) Analytical methods (allows the user to add/edit information regarding analytical methods. The data will serve to populate the commercially available rapid assay test and bibliographic sections; (4) Commercial rapid assay test (data entry/edit function); (5) Commercial rapid assay test subtest data (allows the user to add secondary information regarding the test; (6) Commercial rapid assay test (allows the user to search for drug class and active ingredient); (7) Commercial rapid assay test (sorting and viewing function); (8) Tolerance finder (allows the user to view the tolerances for different matrices and to sort the data). In addition to creating the database, a link was created so that all of the tolerance data from another FARAD database could be linked with the commercial assay section of the database. Data entry was started into the commercial assay section of the database. To date, 221 records have been added to the commercial assay section of the database and these records encompass 29 active ingredients, 5 animal species, and 6 matrices. PARTICIPANTS: This is a collaborative project between the Department of Population and Health and Reproduction and the UC Davis component of FARAD and so depends on the coordination of a variety of individuals, including faculty members within the departments, a research microbiologist, veterinarian consultants, and computer programmers. It also involves the other two universities involved with the FARAD program, North Carolina State University and the University of Florida. TARGET AUDIENCES: The target audiences for this project primarily include food animal veterinary clinicians and various food animal producers. Veterinary clinicians have access to an already existing FARAD program to consult about the pharmacokinetics of drug usage and drug withdrawal intervals in various food animals. This project incorporates a new database of drug detection assays that will be of interest to the same audiences. PROJECT MODIFICATIONS: Nothing significant to report during this reporting period.

Impacts
Approximately 20 websites were reviewed to evaluate how the data extraction would be performed and how the data on the websites would fit into the creation of the database. From this review of the websites, the mainframe of the database was created.

Publications

  • No publications reported this period


Progress 01/01/08 to 12/31/08

Outputs
OUTPUTS: Reviews of the scientific literature encompassing drug residue methodologies were initiated for the specific purpose of identifying potential database fields for the extraction of useful information. Different types of literature including peer-reviewed manuscripts, state and university extension publications, vendor kit inserts, marketing materials, and state and national laboratory protocols and other information were polled and evaluated for potential inclusion into the database. Fields of data entry and search were identified and created. Specific fields and data lists were integrated into one of the prototype databases. Other fields identified to be important to include were, lower limit of detection, maximum residue limits, comment field on potential violative results, analytical sensitivity and specificity, a calculated field to quantitate false negative/positive results, kit or test validation species and matrix, methodology, and sample types studied and concentrations of drugs actually tested. It was also determined to provide web addresses to the major vendor sites to gain access to kit information and updates and that the database should focus on vendor available assay systems rather than research only or otherwise unavailable methodologies. PARTICIPANTS: This is a collaborative project between the Department of Population and Health and Reproduction and the UC Davis component of FARAD and so depends on the coordination of a variety of indivisuals, including faculty members within the departments, a research microbiologist, veterinarian consultants, and computer programmers. It also involves the other two universities involved with the FARAD program, North Carolina State University and the University of Florida. TARGET AUDIENCES: The target audiences for this project primarily include food animal veterinary clinicians and various food animal producers. Veterinary clinicians have access to an aleady existing FARAD program to consult about the pharmacokinetics of drug usage and drug withdrawal intervals in various food animals. This project incorporates a new database of drug detection assays that will be of interest to the same audiences. PROJECT MODIFICATIONS: Nothing significant to report during this reporting period.

Impacts
The results of various searches and reviews of the literature were evaluated and used to make fundamental decisions on the primary architecture of the database to be constructed. It was determined that vendor information, such as availability of rapid test kits, cost of testing, and FDA/AOAC approval, etc. were also important information to include into the databse, as well as using the existing FARAD drug and metabolite numbering system. Two prototype databases were evaluated based on the review of the literature. A very important component of the FARAD database and its management was the ongoing assessment of each manuscript's usefulness to the FARAD mission. Collaborations and discussions were also intitiated with the other universities involved with the FARAD program (North Carolina State University and the University of Florida) and were further pursued during the FARAD 2008 summit meeting.

Publications

  • No publications reported this period


Progress 01/01/07 to 12/31/07

Outputs
OUTPUTS: The purpose of this project is to create a database that will contain searchable scientific data relative to existing antibiotic drug residue testing assays so that veterinarians and producers can be advised as to what assays to use to ensure that various food products are free of drug residues when veterinary products are used in an extralabel manner. Thus the major output of this project is to provide a service through the development of this new database. The data for the new database will focus on commercial assays that are available for testing various matrices (i.e. milk, urine, etc) for the presence of antibiotic residues. The database will be used to disseminate practical information about drug detection methods to veterinary clinicians who consult with the Food Animal Residue Avoidance Databank (FARAD) program about extra-label use of drugs in food animals. Dissemination of this information will be through the existing channels of the FARAD network, which includes consultation via phone lines, scientific conferences, and publications. Ultimately the end users of this information will be veterinary clinicians who are treating food animals and the producers who are selling the animal derived products for human consumption. The information supplied to the veterinarians and producers through this project's efforts will help to ensure the safety of food animal products and so benefit the food animal industry and the general public. PARTICIPANTS: This is a collaborative project between the Department of Population Health and Reproduction and the UC Davis component of FARAD and so depends on the coordination of a variety of individuals, including faculty members within the departments, a research microbiologist, veterinarian consultants, and computer programmers. Ultimately it will also involve other national and international members of FARAD, as they too will benefit from the project's outcomes. TARGET AUDIENCES: The target audiences of this project primarily include food animal veterinary clinicians and various food animal producers. Veterinary clinicians have access to an already existing FARAD program to consult about the pharmacokinetics of drug usage and drug withdrawal intervals in various food animals. This project incorporates a new database of drug detection assays that will be of interest to the same audiences.

Impacts
For years, the FARAD program has provided recommended drug withdrawal intervals (based on theoretical pharmacokinetic data and modeling) when drugs are used in an extralabel manner in food animals. However, these withdrawal intervals are based on theoretical knowledge and the veterinarians and producers are always advised to test the milk/urine prior to allowing the animal to enter the food chain. However, FARAD's focus has been to advise based on pharmacokinetic data and antibiotic assay information has not been the program's focus. Scientific data regarding the use of antibiotic drug assays in an on or off label manner is not currently available in database format. Therefore, the major outcome of this project will be obtain, extract, and categorize scientific data that is available for assays that test for antibiotic drug residues. Currently, commercial assays are marketed for a specific matrix (i.e. milk, urine, etc), a specific drug, and a specific food animal species. However, studies regarding the "off label" use of these assays are often scientifically evaluated and published in the literature. For example, one study might evaluate the use of an assay that was originally designed to detect penicillins in dairy cow milk in milk from goats. The ultimate outcome of this project is to create a searchable database will be contain scientifically validated information regarding both on and off label use of assays. By having this new database, FARAD can go beyond providing veterinarians with just a withdrawal interval, but could also help to provide information as to what assay the veterinarian/producer could use to ensure that the theoretical withdrawal interval will actually coincide what is occurring in the field. This new knowledge will allow FARAD to better advise veterinarians regarding drug residues and enable better decision making by food animal clinicians, leading to a safe and secure food product. This change in knowledge may lead to a change in actions taken by food animal clinicians and producers, ultimately leading to a change in the condition of food animal products. For example, consultation with the new database may provide a test methodology (i.e. a specific assay) that can be used on a specific animal product to ensure that it is devoid of antibiotic residues, and is therefore safe to enter the consumer food chain. This project will provide an additional database to provide information on drug testing methods, thus providing more knowledge to help insure food safety.

Publications

  • No publications reported this period