Michelle D. Motsinger MFRPS Specialist Office of Partnerships
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Transcript of Michelle D. Motsinger MFRPS Specialist Office of Partnerships
U.S. Food and Drug AdministrationOffice of Regulatory Affairs
Manufactured Food Regulatory Program Standards (MFRPS-ISO Sampling Agreements)
Michelle D. Motsinger
MFRPS Specialist
Office of Partnerships
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Objectives
• Provide background on ISO Agreements & MFRPS
• Provide an overview of the requirement for sampling agreements
• Discuss the importance of these agreements• Detail some of the requirements • Provide resources• Provide an update & next steps
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ISO/IEC 17025:2005 State Laboratory Accreditation
• Purpose: Microbiological and chemical food analyses performed on behalf of State manufactured food regulatory programs conducted within the scope of an ISO/IEC 17025:2005 accredited laboratory
• 30 programs participating• Lab programs must:
– Submit a self assessment of laboratory accreditation progress/status, and a cost proposal
– Provide quality management personnel to ensure accreditation success
– Develop an Action Plan– Develop a Proficiency Testing Plan– Obtain training necessary to obtain accreditation– Obtain and maintain accreditation
ISO Funding Background
• 30 State Labs currently have the funding• Requirement for sampling agreement
deliverable was added to the NGAs in 2013 in year 2 of the funding
• This new deliverable will be required moving forward
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Manufactured Food Regulatory Program Standards
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MFRPS Background
• Manufactured Food Regulatory Program Standards
• Arose from FDA OIG Audit in 2000• 10 Standards for Improvement of State
Manufactured food programs• 40 State Programs enrolled/participating• FDA supports via staff assistance and
funding
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Manufactured Food Regulatory Program Standards (MFRPS)
Program Standards1. Regulatory Foundation
2. Training
3. Inspection Program
4. Inspection Audit Program
5. Food-related Illness and Outbreaks and Response
6. Compliance and Enforcement
7. Industry and Community Relations
8. Program Resources
9. Program Assessment
10. Laboratory Support
• 10 Standards to establish a uniform foundation for the design and management of state programs responsible for regulating food plants
• Institute a holistic quality assurance and standardization program
• FDA Program-Assessment Validation Audits (PAVAs) will be conducted at 18, 36, and 60 months
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Manufactured Food Regulatory Program Standards (MFPRS)
• 40 programs in 39 States
Why sample food?
• It is the only way to:
– isolate/identify contaminants in food
– determine the safety of the food
– ensure the food is what the product label declares
• Our public health system demands a safe food supply
• Food may be sampled due to consumer complaint, reported illness, routine inspection/surveillance
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Why ISO/MFRPS and Sampling?
• Propels State food laboratory programs forward
• Enhanced communications amongst state agencies
• Integrated planning
• Advance MFRPS and ISO Sampling
• Standardized food sampling methods
• An Integrated Food Safety System needs to include sampling and State laboratories
• Is a great tool for those with and without ISO funding 10
Importance of Sampling Agreement
• Supports laboratory in obtaining or expanding scope of ISO 17025 accreditation
• Supports manufactured food program in achieving conformance with MFRPS
• 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 food supply 11
How are the ISO Sampling Agreements & MFRPS Connected?
• ISO standards (Sampling in particular) relate to several MFRPS Standards - Specifically
• Standard 3 – Inspections Program• Standard 4 – Inspection Audit Program• Standard 5 – FBI and Outbreak Response• Standard 8 – State Resources• Standard 10 – Laboratory Support
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ISO Sampling Plan Requirement
• Requirements are written into the ISO Cooperative Agreement
– Charges the program to develop & execute a detailed sampling agreement
– Requires the plan to be developed in conjunction with the State MFRPS supported by the lab and FDA
– Recommends agreements should outline the minimum # of samples, types of analysis and frequency of testing annually, including sample collection methods 13
Getting Started…
• Requires proactive dialogue, communication & planning between the food safety program and the laboratory
• Requires agencies working together to develop the plan which will outline what, when, who, why where, how much, etc. in a mutually acceptable manner to create the foundation of their sampling agreement
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Getting Started- Sampling Webinar
• December 2013 – provided a MFRPS national webinar on the topic of Sampling Agreements
• Attendees were State MFRPS and ISO lab grant enrollees, FDA and related association participants
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ISO-MFRPS Sampling Protocol Guidance
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Acceptable Samples
• Manufactured Foods under the purview of FDA• Manufactured Foods under the purview of State
Inspection, if also under FDA jurisdiction• Environmental Samples • Routine Manufactured Food samples• Seafood samples• Processed Shellfish• Bottled Water only (not municipal water) • Samples collected in FBI Outbreaks and on
Complaints• *Produce, if it is washed and processed 17
Unacceptable Samples
• Grade A Dairy products (Milk)• Food produced in a retail setting• Environmental Samples from retail settings• Municipal Water• USDA regulated products• Foods intended for animals• Raw shellfish
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Types of Acceptable Analysis
• Include, but not limited to:– Chemical– Pesticides– Biological– Physical (foreign matter)-filth– Allergens– Metals– Toxins– Contaminants– Specie Substitution/confirmation– Confirmation of product identity - example (Honey).
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Sampling Agreement Example
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Sampling Resources
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Updates
• April 1, 2014: Sampling Agreements due• All 30 were submitted• Review• Feedback• Commonalities
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Next Steps
• Laboratory and Manufactured food programs to finalize their Implementation Strategy by Sept. 1, 2014
• Agreements cover 1 year and are reviewed & revised in the following year
• Practice should be sustained when funding is no longer available
• Future funding
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Additional Resources
• Office of Regulatory Science assistance
Ruiquing Pamboukian, FDA ORS
[email protected] 301-796-8157
• FoodSHIELD, MFRPS Workgroup
Contact your State’s SIS representative• AFDO Portal
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AFDO Portal
• Interested in becoming accredited?
http://www.aphl.org/aphlprograms/food/laboratory-accrediation/pages/default.aspx
• Contact: Dare Akingbade, APHL for access to the Discussion Board
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Question and Answers
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I nailed that presentation!!!
Contacts
Food ProgramSIS Representative
Guy DeliusAngela Kohls
Tressa MaddenMichelle Motsinger
Priscilla Neves
Cooperative Agreement FundingErin Woodom-Coleman, Contracts Project Officer
Laboratory Sampling PlanOffice of Regulatory [email protected]
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SIS Contacts
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Guy Delius- [email protected] Angela Kohls- [email protected] Tressa Madden- [email protected]
Michelle Motsinger- [email protected] Priscilla Neves- [email protected]