FSM: What can we expect going forward with regard to collaboration with states and the
U.S. Department of Agriculture (USDA) on FSMA enforcement?
DA: More collaboration between states and FDA for sure. Not sure about USDA-FSIS [Food
Safety and Inspection Service], but I suspect that AMS [Agricultural Marketing Service] will get
more into the act as they did with the LGMA [Leafy Green Marketing Agreement].
DB: I think it will largely
depend on budget and
WC: We can expect to
see FDA continue to collaborate with USDA and
state agencies to implement and enforce FSMA regulations. FDA has emphasized collaboration as a main pillar of its
FSMA strategy and has worked to strengthen ties with state agencies and allocate resources to
support their FSMA efforts to enhance the agency’s involvement with the regulated industry.
FDA and USDA announced a formal agreement in January of this year to bolster coordination and collaboration on produce safety and biotechnology. The aim of the agreement is to
streamline regulatory responsibilities and use resources more efficiently to protect public health
by reducing the number of establishments subject to regulatory requirements of both USDA
FDA is coordinating with state and/or territorial government agencies, which will conduct
most farm inspections under the Produce Safety rule. Additionally, FDA along with the USDA
has funded a network of public and private partners in state, federal, tribal and international
governments, industry, and academia for the development and delivery of training to support
FSMA compliance by making FSMA training accessible and comprehensive.
AS: Just as in previous rules on FDA-regulated foods (e.g., LACF, acidified foods, Juice and
Seafood HACCP), it is conceivable that USDA will adopt or use as a model with minimal
modifications, if any, FSMA rules for enforcement on the foods they regulate. This action will
also highlight the intent of FSMA that the new law is a partnership, not only among regulatory
agencies but also with the private sector, academia, individual businesses, and the consumer.
But we all just have to wait and see.
TK: FSMA forces FDA and USDA to enhance their collaboration and cooperation on produce
safety activities. The formal agreement was signed in 2018 and tasks both agencies with identifying ways to streamline regulation and reduce inspection inefficiencies. This can reduce costs
on industry and free government resources to better target efforts to areas of risk. n
We would like to thank all the panelists for their insightful comments and engaging discussion.
David W. K. Acheson, M.D., F.R.C.P., is the president and CEO of the Acheson Group.
John M. Ryan, Ph.D., PCQI, is the founder and president of Ryan Systems Inc.
Dan Brooks, PCQI, is regional food safety consultant, John Bean Technologies (International) Ltd., Bangkok, Thailand.
Willette M. Crawford, Ph.D., M.P.H., is the founder and principal consultant of Katalyst Consulting LLC.
Aurora A. Saulo, Ph.D., is a professor and Extension Specialist in Food Technology of the College of Tropical Agriculture and
Human Resources, University of Hawaii at Manoa.
Tatiana Koutchma, Ph.D., is a research scientist at Agriculture and Agri-Food Canada.
Larry Keener is the president and CEO of International Product Safety Consultants and a member of the Food Safety Magazine
Editorial Advisory Board.
“...FDA is committed to work with
industry and other partners on
white papers and through task
forces that will guide industry on
the validation of new technologies.”
–Tatiana Koutchma, Ph.D.
(continued from page 41)
of corrective actions. This
type of focus can provide a
basis to prevent disruptions
to production from breakdowns and product contamination.
We have discussed multiple methods to create,
implement, validate, verify,
and sustain an FMPP. The
bottom line to the success
of any process improvement
program is management
commitment. The resources
must be provided for any
program to function to its
full capability. A systematic,
data-driven, pragmatic approach toward incrementally
removing, replacing, and
conditions and processes
can provide remarkable results and prevent injuries to
those that trust us to keep
them safe. n
Dr. John W. Raede is the chief food
safety officer for National Cortina, an
Importer of Record for grass-fed beef,
individually quick-frozen vegetables,
and edible oils. He has 30 years of
food industry and food safety experience, spanning from meat animal
production to individual quick-freezing
vegetable processing. He spent 20
years with Nestlé USA in global supply
chain quality. During his time at Nestlé,
he earned his master’s and doctorate
degrees in business management. Dr.
Raede specializes in food safety supply chain process improvement, risk
mitigation, and FM assessment and
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