ISO Sampling Agreement Requirements and
National Sampling Plan
Guy F. Delius
CSO FDA
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
supply.
• 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
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.
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.
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
Agreements.
• Attendees were State MFRPS and ISO lab
grant enrollees, FDA and related association
participants.
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
– MFRPS
– Food Emergency Response Network
– etc
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
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
foods
– 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
feedback
• Stay tuned…
• Thanks
Contact Information
Tim McGrath Acting Deputy Director
FDA ORA ORS
Guy F. Delius CSO
FDA ORA OP
Email: guy.delius@fda.hhs.gov
Email: Timothy.McGrath@fda.hhs.gov
Email: Ruiqing.Pamboukian@fda.hhs.gov
Email: Erin Wooden-Coleman@fda.hhs.gov