Delius and McGrath Presentation - MFRPA 2014

ISO Sampling Agreement Requirements and
National Sampling Plan
Guy F. Delius
Tim McGrath
Acting Deputy Director ORS-FDA
March 10, 2014
1:15-1:45 pm
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
• Food may be sampled due to consumer complaint,
reported illness, routine inspections, routine
surveillance, etc.
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
Integrated Food Safety Systems and
• 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
• Now - there is an opportunity to further integrate the
food safety programs with the food safety
laboratories regarding sampling.
ISO Sampling Plan Requirement
The requirement is written in your ISO Cooperative
• 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.
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.
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.
Sampling Webinar
• December 2013 we provided a MFRPS
national webinar on the topic of Sampling
• Attendees were State MFRPS and ISO lab
grant enrollees, FDA and related association
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)
Future Sampling Assignments
• Potential tie-ins to:
– Integrated Food Safety System
– Food Safety Modernization Act
– Food Emergency Response Network
– etc
Future Sampling Assignments
• Still in development
• Not a substitute for developing a sampling
• Assignments to be developed in
spring/summer ‘14
• Sampling/analysis to begin FY’15
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.
Large-Scale Surveillance Assignments
• Food Safety Modernization Act (FSMA) calls for a more riskinformed 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
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
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
– Ensure adequate monitoring
– Support regulatory actions; establish policy
• Large numbers of samples to be analyzed (1200+)
• Will require utilization of State agencies (labs)
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
• Stay tuned…
• Thanks
Contact Information
Tim McGrath Acting Deputy Director
Guy F. Delius CSO
Email: [email protected]
Email: [email protected]
Email: [email protected]
Email: Erin [email protected]

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