ISO 17025:2005 Laboratory Accreditation Competition ......Animal Feed Program Standards Cooperative...
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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 Officer FDA Office of Partnerships February 2, 2016
Transcript of ISO 17025:2005 Laboratory Accreditation Competition ......Animal Feed Program Standards Cooperative...
Animal Feed Program Standards Cooperative Agreement Program
ISO 17025:2005 Laboratory Accreditation Competition:
Program Session
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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
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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
– Grantee Names: Regulatory Agency & Laboratory Names
– 2015/16 Mid-Year Report
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Mid-Year Progress Report
• Suggested template – will be provided but not a requirement to use
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Mid-Year Progress Report• At the top of Progress Report, add a Report Header
– Author of Report Name, phone number & email address
– PI Name, phone number & email address
– Grant Number
– Grantee names & addresses: Regulatory and Laboratory
– Report Period covered/Project Period/Budget Period/Project Title
– Report Submission Date
• Who do I send my Mid-Year Progress Report to:– [email protected]
• Please also “cc” your Mid-Year Progress Report to:– Assigned OP SIS AFRPS Technical Advisor
– Assigned ORS Assessor
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Mid-Year Progress Report
• 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
_______________________ _____________________________
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Sampling Agreement and Sampling Plan
• Due Date: August 31, 2016
• Who do I send my Sampling Agreement and Sampling Plan to:
– Assigned ORS Assessor and ISO mail box ([email protected])
• Please also “cc” to:– [email protected]
– Assigned OP SIS AFRPS Technical Advisor
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Eric Nelson
Director of ComplianceCenter for Veterinary Medicine (CVM) Office of Surveillance and Compliance
Division of Compliance
Present and Future State Feed Contaminants CPGM
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Present and Future State
of Feed Contaminants
CPGMFDA,
Center for Veterinary Medicine
Office of Surveillance and Compliance
Present State Feed
Contaminants Program
• Pesticides, Industrial chemicals
• Elements
• Mycotoxins
• Microbes
• Dioxin
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Yearly # of Samples Requested
• Domestic (963), Import (845)
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Domestic Import
Pesticides, Industrial
Chemicals
250 495
(chem and others)
Elements 105
Mycotoxin 338
Microbes 100 350
Dioxin 150
Antibiotics 20
FY13 Pesticide Data
CategorySamples Analyzed
Without
Residues # (%)
Violative
Samples # (%)
Totals - All Samples 420 217 (51.7) 8 (1.9)
Sample Origin
Domestic 254 118 (46.5) 4 (1.6)
Import 166 99 (59.6) 4 (2.4)
Commodity Type
Whole and Ground Grains/Seed
178 135 (75.8) 2 (1.1)
Mixed Livestock Food Rations 109 32 (29.4) 2 (1.8)
Medicated Livestock Food Rations
17 3 (17.7) 0 (0.0)
Plant By-products 50 30 (60.0) 4 (8.0)
Hay and Silage 8 4 (50.0) 0 (0.0)
Animal By-Products 7 2 (28.6) 0 (0.0)
Pet Food/Treats 44 5 (11.4) 0 (0.0)
Other Animal Food Ingredients 7 6 (85.7) 0 (0.0)
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FY12 Mycotoxin Data
Mycotoxins Analyzed Positive Range Above
Guidance
Aflatoxins 166 19 (1.6 - 86.1 ppb) 7
Fumonisins 55 43 (0.1 - 7.5 ppm) 1
Vomitoxin 60 18 (0.1 - 4.7 ppm) 0
Zearalenone 37 7 (61 - 250 ppb) NOG
Ochratoxin A 10 2 (11.6 - 15.9 ppb) NOG
Total 328 89
* 7 samples positive for two mycotoxins
Analyses were conducted using either an ELISA multi-mycotoxin residue screen, or a
more specific quantitative method for the specific mycotoxins.
Mycotoxin Surveillance Program
– Aflatoxins in corn, corn and peanut products,
and complete feed
– Fumonisins in corn, corn products and feed
– Vomitoxin (deoxynivalenol) barley, wheat and
swine feed
– Zearalenone in swine feed and pet food
– Ochratoxin A in oats
Mycotoxins# of
SamplesPositive samples Above guidance
No % No. % of positive
Aflatoxin 4757 623 13.1 181 29.0
Fumonisin 1184 652 55.1 72 11.0
Vomitoxin 475 234 49.3 24 10.3
Zearalenone 580 78 13.4 71 100*
Ochratoxin A 207 21 10.1 19 100*
1994-2012 Mycotoxin Data
* No established guidance levels
Microbes: Salmonella
• Objectives– Determine the prevalence of Salmonella
– Determine the serovar, genetic fingerprint, and antimicrobial susceptibilities of each isolate
– Take action for controlling the presence of Salmonella
• Assignments– Pet food: 2007 – 2013
– Poultry feed: 2012
– Milk replacer: 2013
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Future State of Feed
Contaminants Program
• Continuation of Surveillance Sampling
– Chemical, Biological, Pathogenic
• Supporting FSMA Compliance
– PC Confirmation
– Hazard Identification and Prevalence
– Policy Development
• Sample Data Sharing 39
Feed SamplingState Perspective
Laboratory/Program Perspectives
Mark LeBlanc, AAFCO President
“Grand Dog” Wilson
History
• States have been regulating animal feed for over 100 years.
• Original need for regulation revolved around economic adulteration.
• Need for common methods of analysis drove the creation of methods to determine crude protein, crude fat and crude fiber.
• For most of the history of feed regulation, the focus has been on economic adulteration. Is the farmer getting what he is paying for?
• Feed Regulatory Programs have had to adjust as different challenges emerged regarding adulteration.
• Focus has shifted from entirely economic sampling to include safety for man and animal.
• Each state will have its own perspective on sampling priority.
– Widely different feed commodities
– Common adulterants can vary depending on location.
• For example Aflatoxin in the southeast vs other mycotoxins in the midwest.
– Each state has its own perspective on economic vs feed safety sampling.
– Each state may have a different perspective on risk
This can be a challenge.
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Laboratory/Program Interaction
• Tools to improve relationship
• Communication
• Mutual understanding
• Inspector/Analyst exchanges
• Communication
• Regular meetings
• Communication
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Laboratory/Program Interaction
• Risk
– Economic and safety
• Opportunity
– What is in commerce?
• Budgetary
– Staffing Limitations
– Quality vs Quantity?
• Representativeness vs Practicality 46
Regulatory Program Considerations
for Sampling Plan
• Capacity
– Staffing
– Throughput Limitations
• Capability
– Instrumentation
– Expertise
• Sample Integrity
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Laboratory Considerations
for Sampling Plan
• Lab and Program must agree on• Sample timing
• Sample matrices and analytes
• Sample throughput time
• Sample integrity/chain of custody
• Sample storage and retention
• Record storage and retention
• Means of sharing analytical data
• Laboratory security
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Joint Sampling Plan
Mark LeBlanc
AAFCO President
Director Agricultural Chemistry
LSU AgCenter/La Dept. of Ag and Forestry
AAFCO.ORG
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Questions?
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THINK HARD & ASK US
