ISO Sampling Agreement Requirements and National Sampling Plan
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Transcript of ISO Sampling Agreement Requirements and National Sampling Plan
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ISO Sampling Agreement Requirements and National Sampling Plan
Guy F. DeliusCSO FDA
Tim McGrathActing Deputy Director ORS-FDA
March 10, 20141:15-1:45 pm
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Why Sample food?
• Other than primitive visual and organoleptic methods , Food sampling through sound collection methods and proven laboratory processes is the only way to isolate/identify contaminants in food/determine the safety of the food and 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 inspections, routine surveillance, etc.
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Why sample food in a standardized and appropriate manner?
Standardized proven methods of sample collection and analysis:– Statistically relevant – produce meaningful and accurate results– legally defensible– Necessary for an integrated uniform system for
sampling and analysis– Necessary for mutual acceptance of data
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Integrated Food Safety Systems and Sampling
• National movement towards an Integrated Food Safety System (IFSS).
• More State Food Safety programs are enrolled in Manufactured Food Regulatory Program Standards (MFRPS) and/or Retail Standards.
• More Food Safety State Laboratory programs are funded to achieve ISO accreditation or are already accredited.
• Now - there is an opportunity to further integrate the food safety programs with the food safety laboratories regarding sampling.
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ISO Sampling Plan Requirement
The requirement is written in your ISO Cooperative Agreement: • Charges the program to develop and execute a
detailed sampling agreement.• Requires the plan to be developed in conjunction
with the State MFRP supported by the lab and FDA.• Recommends agreements should outline minimum #
of samples, types of analysis and frequency of testing annually, including sample collection methods.
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Sampling Plan Development
• The development of the sampling plan requires proactive dialogue, communication and planning between the food safety program and the food safety laboratory.
• These agencies together, develop the plan outlining what, when, who, why, where, how much, etc., in a mutually acceptable manner. This is the foundation of their Sampling Agreement.
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Timeframes for Development of Plan
• Laboratory and Manufactured Food Program Sampling Agreement due date: Extended until April 1, 2014.
• Laboratory and Manufactured food program to finalize the Implementation Strategy by Sept. 1, 2014.
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Sampling Webinar
• December 2013 we 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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Sampling Webinar Highlights
• Discussed a Sampling protocol document which outlined the types of Samples that would be appropriate for this initiative (Provided in your handouts)
• Discussed an example of a Sampling Plan Agreement Template (Provided in your handouts)
• Discussed a Sampling Resources document (Provided in your handouts)
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Future Sampling Assignments
• Potential tie-ins to:– Integrated Food Safety System – Food Safety Modernization Act– MFRPS– Food Emergency Response Network– etc
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Future Sampling Assignments
• Still in development• Not a substitute for developing a sampling
plan• Assignments to be developed in
spring/summer ‘14• Sampling/analysis to begin FY’15
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Future Sampling Assignments• Envisioned assignments to be developed in consultation
with other FDA Centers• Suggested proposals currently include
– Large-scale surveillance assignments• Large number of samples
– Large-Scale Produce Testing• Similar to USDA Microbiological Data Program (MDP)• Pre-arranged scheduling
– National Events Surveillance Testing• Political conventions, etc.
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Large-Scale Surveillance Assignments
• Food Safety Modernization Act (FSMA) calls for a more risk-informed and preventive approach to FDA activities
• This effort builds upon risk ranking activity completed by a multidisciplinary group from FDA
• New initiatives to better understand hazard, identify mitigation strategies, and determine the effectiveness of FDA activities. Improved sampling processes can assist with these initiatives
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Large-Scale Surveillance Assignments
• FDA seeks to:
– develop a roadmap to utilize data to inform more targeted surveillance sampling
– focus on those commodities that align to the highest public health risk
– produce an adequate number of samples and data points to inform the agency’s inspectional, policy and research programs
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Large-Scale Surveillance Assignments
• Past surveillance sampling efforts may not have consistently yielded statistically-significant data that could be used to:– Proactively fill knowledge gaps related to contamination of high-risk
foods– Ensure adequate monitoring– Support regulatory actions; establish policy
• Large numbers of samples to be analyzed (1200+)
• Will require utilization of State agencies (labs)
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Future Sampling Assignments
• Still under construction• Great opportunities to bring together many federal-state
initiatives and programs• Helps to show value of such programs (and the funding)
• As the opportunities develop, we will seek input and feedback
• Stay tuned…
• Thanks
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Contact Information
Tim McGrath Acting Deputy DirectorFDA ORA ORS
Guy F. Delius CSO FDA ORA OP
Email: [email protected]: [email protected]
Email: [email protected]: Erin [email protected]