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

1

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

2

3

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

4

Manufactured Food Regulatory Program Standards

5

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

6

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

7

8

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

9

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

12

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

14

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

15

ISO-MFRPS Sampling Protocol Guidance

16

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

18

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).

19

Sampling Agreement Example

20

Sampling Resources

21

Updates

• April 1, 2014: Sampling Agreements due• All 30 were submitted• Review• Feedback• Commonalities

22

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

23

Additional Resources

• Office of Regulatory Science assistance

Ruiquing Pamboukian, FDA ORS

Ruiquing.pamboukian@fda.hhs.gov 301-796-8157

• FoodSHIELD, MFRPS Workgroup

Contact your State’s SIS representative• AFDO Portal

24

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

dare.akingbade@aphl.org

25

Question and Answers

26

I nailed that presentation!!!

Contacts

Food ProgramSIS Representative

Guy DeliusAngela Kohls

Tressa MaddenMichelle Motsinger

Priscilla Neves

Cooperative Agreement FundingErin Woodom-Coleman, Contracts Project Officer

Erin.Woodom-Coleman@fda.hhs.gov240-205-1606

Laboratory Sampling PlanOffice of Regulatory ScienceCFSAN-ORS@fda.hhs.gov

27

SIS Contacts

28

Guy Delius- GreenGuy.Delius@fda.hhs.gov Angela Kohls- TanAngela.Kohls@fda.hhs.gov Tressa Madden- PinkTressa.Madden@fda.hhs.gov

Michelle Motsinger- PurpleMichelle.Motsinger@fda.hhs.gov Priscilla Neves- BluePriscilla.Neves@fda.hhs.gov