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:– Daniel.Lukash@fda.hhs.gov

– Teresa.Bills@fda.hhs.gov

• 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 (ISO@fda.gov)

• Please also “cc” to:– Teresa.Bills@fda.hhs.gov

– Ruiqing.pamboukian@fda.hhs.gov

– 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

Mark_l@ldaf.state.la.us

AAFCO.ORG

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Questions?

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THINK HARD & ASK US