Animal Feed Program Standards Cooperative Agreement Program ISO 17025:2005 Laboratory Accreditation Competition: Program Session 1 Ruiqing Pamboukian Ph.D., Laboratory Accreditation Program Lead FDA Office of Regulatory Science Teresa Y. Bills, Project Officer FDA Office of Partnerships February 2, 2016
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Animal Feed Program Standards Cooperative Agreement Program
ISO 17025:2005 Laboratory Accreditation Competition:
Program Session
1
Ruiqing Pamboukian Ph.D., Laboratory Accreditation Program Lead FDA Office of Regulatory Science
Teresa Y. Bills, Project OfficerFDA Office of Partnerships
February 2, 2016
SPEAKERS & PRESENTATION TITLES
• Teresa Bills, Project Officer, Office of Partnerships, Contracts and Grants Staff (CGS)
Title: Mid-Year Progress Report – What is expected?
• Isaiah Isakson, OP SIS AFRPS Technical Advisor, Office of Partnerships (OP), Standards Implementation Staff (SIS)
Title: AFRPS Sampling Agreement-Plan
• Ruiqing Pamboukian Ph.D., Laboratory Accreditation Program Lead, LCDR, U.S. Public Health Service, Office of Regulatory Science
Title: Sample Agreement-Plan Template and Instructions
2
SPEAKERS & PRESENTATION TITLES
• Eric Nelson, Director of Compliance, Center for Veterinary Medicine (CVM), Office of Surveillance and Compliance, Division of Compliance
Title: Present and Future State Feed Contaminants CPGM
• Mark LeBlanc, Director of Agricultural Chemistry, Louisiana Department of Agriculture and Forestry & President of Association of American Feed Control Officials (AAFCO)
Title: Feed Sampling State Perspective
Laboratory/Program Perspectives
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Teresa Y. Bills
Project Officer
Office of Partnerships (OP)
Contract and Grants Staff (CGS)
Mid-Year Progress Report
What is expected?
Mid-Year Progress Report
• Only one (1) Mid-Year report is due from the AFRPS CA grantees
• The laboratories do not need to prepare a separate Mid-Year report for ORS
• The laboratory progress report information provided in the Mid-Year report will be shared with ORS
MID-YEAR PROGRESS REPORT DUE DATE:
MARCH 31, 2016
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Mid-Year Progress Report
• Mid-Year report – is a comprehensive report that will provide the specific information
referenced in the grantee’s Notice of Grant Award (NGA)
– will indicate the progress of the Regulatory and Laboratory grantees jointly
• What to put in email Subject Line– AFRPS CA Grant Number
• Per your NGA, the following information required in the Mid-Year Progress Report
1. Description of project activities covering the applicable reporting period
– Detailed progress report on the grantee meeting the project goals detailed in the cooperative agreement and identified in the application
– Status report on the hiring and training of feed program personnel
– Certification of current State appropriation funding levels for the State animal feed regulatory program
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Mid-Year Progress Report
• Per your NGA, the following information required in the Mid-Year Progress Report continues…
– Submission of the following documents in the most current version of the AFRPS. These documents must be current and fit for use.
• Appendix 2.1 or alternate form that is equivalent
• Appendix 3.1 or alternate form that is equivalent
• Appendix 4.1, 4.3, 4.6, 4.8, 4.10, 4.11 or alternate form that is equivalent
• Appendix 5.1 or alternate form that is equivalent
• Appendix 6.1 or alternate form that is equivalent
• Appendix 7.1 or alternate form that is equivalent
• Appendix 8.1 or alternate form that is equivalent
• Appendix 9.1 and 9.2, or alternate form that is equivalent
• Appendix 10 or alternate form that is equivalent
• Appendix 11 or alternate form that is equivalent
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Mid-Year Progress Report
• Additional information requested in the Mid-Year Progress Report
2. Discuss any issues with expenditures
2. List Points of Contact and Project Key Personnel
(Regulatory & Laboratory)
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Mid-Year Progress Report
• In addition to the NGA information, laboratory partners should also report
1. General progress or status of specific items listed below:
– Accreditation Action Plan
– Proficiency Tests
– Participation in FERN activities
– Mentor/Mentee Involvement
– Sampling Agreement
– eLEXNET Data entry
2. Reference any pending issues/concerns
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Isaiah Isakson
OP SIS AFRPS Technical Advisor
Office of Partnerships (OP)
Standards Implementation Staff (SIS)
AFRPSSampling Agreement-Plan
Standard 10: Laboratory Services
• This standard describes the elements of utilizing regulatory testing laboratory services that support the State animal feed program.
• (10.1 Purpose)
Program Elements – 10.3Laboratory Services and Agreements
• State program maintains a list of routine and non-routine analytical services provided by regulatory testing laboratories
• State program has a documented formal agreement with the laboratory (ies) that conduct routine analytical services, unless the laboratory is managed within the program
Program Elements – 11.3.A.Sampling Plan
• Jointly developed and amended by the State program and laboratories performing routine services
• Sampling plan outlines the State program’s:– Sampling priorities
– Sample analysis schedule
– Availability or coordination of analytical support
– May include estimates of analytical costs
Program Elements – 10.3Sample Analysis Schedule
• State program prepares a sample analysis schedule based on a sampling plan in cooperation with laboratories performing routine services to ensure compatibility with laboratory capabilities & capacities
• At a minimum, sample analysis schedule must include: – Type(s) of feed to be analyzed
– Number of samples to be collected
– Estimated timeframe for collection
– Type(s) of analysis to be performed
Program Elements – 10.3.Communication Procedures
• In collaboration with the laboratories, the State program establishes standard procedures and a means to communicated necessary information for sample:
Submission Shipping Preservation Storage
Retention Disposal Chain of custody, and Report of analysis
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Ruiqing Pamboukian Ph.D.
Laboratory Accreditation Program Lead LCDR, U.S. Public Health Service
Office of Regulatory Science
Sample Agreement/Plan Instructions
Sampling Agreement/Plan Instruction- Template to use
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Importance of Sampling Agreement
• Supports laboratory in obtaining or expanding scope of ISO 17025 accreditation
• Supports Animal food program in implementing AFRPS
• Successful programs will exhibit integrated planning and enhanced/routine communications between the Laboratory and Feed program regarding sampling.
• Meets the goals of the RFA – Lab commitment to analyze surveillance and emergency samples
– Sharing lab results through eLEXNET
– Increase national lab capacity and enhance efforts to protect the animal food/feed supply
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EXAMPLE
State AFRPS-ISO Sampling Agreement
State Laboratory Agency
Titles and Address
State Feed Regulatory Program Agency
Titles and Address
Date
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Concerning: The Animal Feed Regulatory Program Standards (AFRPS) and AFRPS Cooperative Agreement (CA) ISO 17025 Competition.
The Following sampling agreement is between the _[insert name of State feed regulatory agency]_________and the _[insert state feed laboratory]_________ to ensure a sound plan regarding sampling of animal feed and feed ingredient products for protecting the public’s health (human and animal). This agreement and the program described below support the sampling objective required by the AFRPS Cooperative Agreement and state feed regulatory programs implementation of the AFRPS.
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Does your state have a feed sampling agreement/plan in place?
Yes No
Does your state routinely collect feed samples for analysis?
Yes No
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Please summarize below either your current or your proposed sampling agreement/plan:
• Number of Samples schedule for FY 16 (breakdown by contaminant/hazard and commodity – corn, cotton, distillers, feed ingredients, finished feed, etc)
• Types of Analysis to be performed:– Chemical Contaminant: Mycotoxins, Pesticides, Industrial
Chemicals, Elements (heavy metals), Dioxin, Antibiotics, etc.
– Microbial (Salmonella, E. Coli, Listeria, etc),
– Physical Contaminants: metal, wood, etc.
– Nutritional (including nutritional deficiencies): vitamins, minerals, etc.
– Misc: guarantee analysis, etc
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• Sample collection frequency (quarterly, 2x/year, seasonal, etc.)
• Program (routine inspection, imports, etc.)
• Outline how these sampling proposals support the animal feed priorities of the State
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Please attach the following supporting documents:
• Sampling plan outlining the State program’s sampling priorities, the sample analysis schedule, and the availability or coordination of analytical support (AFRPS Std. 11 program elements 11.3 A)
– Laboratory capability
– Enforcement capability
• Sampling procedures including methods for collecting, storing and transporting samples, and instructions for documenting the sample collection (AFRPS Std. 11 program elements 11.3 B)
• Laboratory methods
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The sampling agreement relates to the timelines outlined in the AFRPS Cooperative Agreement (CA) ISO 17025 Competition.
Director of Animal Feed Safety Director of the Feed Laboratory