U.S. Food and Drug Administration
Office 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
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– 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)
• 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
Program Standards
1.
2.
3.
4.
5.
Regulatory Foundation
Training
Inspection Program
Inspection Audit Program
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
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Manufactured Food Regulatory
Program Standards (MFPRS)
• 40 programs in 39 States
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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
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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
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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
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sample collection methods
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
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Unacceptable Samples
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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:
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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
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•
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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
Ruiquing.pamboukian@fda.hhs.gov 301796-8157
• 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/laborat
ory-accrediation/pages/default.aspx
• Contact: Dare Akingbade, APHL for access
to the Discussion Board
dare.akingbade@aphl.org
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Question and Answers
I nailed that
presentation!!!
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Contacts
Cooperative Agreement Funding
Erin Woodom-Coleman, Contracts Project Officer
Erin.Woodom-Coleman@fda.hhs.gov
240-205-1606
Food Program
SIS Representative
Guy Delius
Angela Kohls
Tressa Madden
Michelle Motsinger
Priscilla Neves
Laboratory Sampling Plan
Office of Regulatory Science
CFSAN-ORS@fda.hhs.gov
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SIS Contacts
Guy Delius- Green
Guy.Delius@fda.hhs.gov
Angela Kohls- Tan
Angela.Kohls@fda.hhs.gov
Tressa Madden- Pink
Tressa.Madden@fda.hhs.gov
Michelle Motsinger- Purple
Michelle.Motsinger@fda.hhs.g
ov
Priscilla Neves- Blue
Priscilla.Neves@fda.hhs.gov
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