The Reportable Food Registry (RFR) has been around for more than a decade, but many manufacturers still don’t know exactly what kinds of issues need to be reported, nor when, or how to report them. Yet, failing to report an issue to The Reportable Food Registry (RFR) can have serious consequences.

1. FSMA Fridays Webinar Series
Monthly Industry News, Updates & Trends for Food, Beverage, & CPG Manufacturers
Making Sense of the FDA’s Reportable Food Registry
with Mary Hoffman, MS, The Acheson Group
May 21, 2021

2. Monthly Industry Update:
✔ FSMA Related News
✔ Regulation Changes & Updates
✔ Industry Trends
✔ Q&A with TAG
What is FSMA Fridays?
FSMA FRIDAYS

3. Casual but Professional Format
✔ Ask questions! (Q&A at end)
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✔ Recording link will be shared
✔ Audio issues: use call-in number
Watch prior FSMA Friday recordings at
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Before We Get Started
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4. Featured Panelist: Mary Hoffman, MS
FSMA FRIDAYS
Aaron Bolshaw
VP Marketing
Mary Hoffman
Director of Food Safety
● 17+ years of experience in food safety/quality
program development and continuous improvement
● Leads proactive initiatives to ensure food safety,
(including supply chain risk mitigation, allergen
control, environmental controls & monitoring, and
behavior-based food safety culture programs)
● BS (Biology) from Carroll University, Master of
Agriculture and Life Sciences with an emphasis in
Food Safety and Biosecurity from Virginia
Polytechnic Institute and State University

5. FSMA FRIDAYS
The Latest FSMA Updates
1. FSVP Portal for Records Submission
2. Leafy Green Initiative
3. Allergen FASTER Act

6. The
Reportable
Food Registry
May 2021, Presented by:
Mary Hoffman
Director, Food Safety

7. Title
Overview
•History of the RFR
•Requirements
•Process
•Consequences
FSMA Fridays is sponsored by SafetyChain (safetychain.com) and The Acheson Group (www.achesongroup.com)

8. History of the RFR
• Statute was passed in 2007
• Became a requirement in 2009
• To prevent distribution of a product that may be
adulterated
• Focus inspections where the risks are
FSMA Fridays is sponsored by SafetyChain (safetychain.com) and The Acheson Group (www.achesongroup.com)

9. Basic Requirement
The RFR requires a responsible party to file a report through the RFR electronic
portal when there is a reasonable probability that the use of, or exposure to, an
article of food will cause serious adverse health consequences or death to
humans or animals.
FSMA Fridays is sponsored by SafetyChain (safetychain.com) and The Acheson Group (www.achesongroup.com)

10. Title
Responsible Party
• Applies to those that manufacture, process, pack or
hold food for human or animal consumption in the
US
• The responsible party is the person who submits
registration information to FDA
FSMA Fridays is sponsored by SafetyChain (safetychain.com) and The Acheson Group (www.achesongroup.com)

11. What is a Reportable Food
A “reportable food” is an article of food (other than dietary supplements or infant
formula) for which there is a reasonable probability that the use of, or exposure to,
such article of food will cause serious adverse health consequences or death to
humans or animals.
FSMA Fridays is sponsored by SafetyChain (safetychain.com) and The Acheson Group (www.achesongroup.com)

12. Key Questions
• Is this a situation that will result in a serious adverse health consequence or death
• What is the situation (microbiological, chemical, physical)
• Some obvious, some challenging
• Conduct a Health Hazard Evaluation
•Where did the problem originate?
•Incoming ingredient
•Product you manufactured
•Where is the product/ingredient of concern?
•In your facility/warehouse
•On a truck that you own
•On a truck that you do not own
•In a third-party warehouse but you control when it is shipped
•With a customer
FSMA Fridays is sponsored by SafetyChain (safetychain.com) and The Acheson Group (www.achesongroup.com)

13. Title
I Don’t Think I Need an RFR
Three questions:
1. The adulteration originated with the responsible party
AND
2. The responsible party detected the adulteration prior to any
transfer to another person of the article of food
AND
3. The responsible party corrected the adulteration or destroyed or
caused the destruction of the article of food.
FSMA Fridays is sponsored by SafetyChain (safetychain.com) and The Acheson Group (www.achesongroup.com)

14. We have a RFR Situation
• Must report as soon as possible
• 24 hours maximum
• Initial report is filed online:
www.safetyreporting.hhs.gov.
• Must investigate the root cause if originated
with you
• Must report key data elements
FSMA Fridays is sponsored by SafetyChain (safetychain.com) and The Acheson Group (www.achesongroup.com)

15. Key Data Elements 1
• Food Facility Registration Number
• Date the article of food was determined to be reportable
• Description of the food, including quantity and amount
• Extent and nature of the adulteration
• Results of investigation of the root cause of the adulteration if it may have
originated with the responsible party, when known
FSMA Fridays is sponsored by SafetyChain (safetychain.com) and The Acheson Group (www.achesongroup.com)

16. Key Data Elements 2
• Disposition of the article of food, when known
• Product information typically found on packaging sufficient to identify the article
of food
• Contact information for the immediate previous sources (suppliers) and/or
immediate subsequent recipients (customers) of the article of food, when
required by FDA
FSMA Fridays is sponsored by SafetyChain (safetychain.com) and The Acheson Group (www.achesongroup.com)

17. Title
What happens next?
• Responsible party
• After filing FDA will issue a unique number Individual Case Safety Report (ICSR)
• May be required to provide notification to immediate previous sources (suppliers)
and immediate subsequent recipients (customers)
• Must provide amended reports as necessary
• Maintain records for two years
• FDA Risk Control Review
• Assess whether the subject food or feed meets the definition of a reportable food
• Rapid collaboration and coordination between FDA field offices, state officials, and
other agencies as needed
FSMA Fridays is sponsored by SafetyChain (safetychain.com) and The Acheson Group (www.achesongroup.com)

18. Title
Consequences
Failure to report a reportable food is a prohibited act under the Federal Food, Drug,
and Cosmetic Act.
FSMA Fridays is sponsored by SafetyChain (safetychain.com) and The Acheson Group (www.achesongroup.com)

19. Do You Need to File an RFR?
Your supplier informs you that an ingredient they
sent you contained an undeclared peanut allergen.
You have not yet used the ingredient.
FSMA Fridays is sponsored by SafetyChain (safetychain.com) and The Acheson Group (www.achesongroup.com)

20. Do You Need to File an RFR?
You got a call from a customer saying they
found pieces of plastic in your product.
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21. Do You Need to File an RFR?
Your finished product was accidentally shipped before
you received testing results. The lab just called to
report that they found a positive for L. mono.
FSMA Fridays is sponsored by SafetyChain (safetychain.com) and The Acheson Group (www.achesongroup.com)

22. Do You Need to File an RFR?
You conducted pre-shipment testing of an
ingredient and obtained a positive Salmonella
result. None of that ingredient lot had been
received at your facility.
FSMA Fridays is sponsored by SafetyChain (safetychain.com) and The Acheson Group (www.achesongroup.com)

23. Do You Need to File an RFR?
The plant informed you they had discovered
damaged equipment and missing bolts. The plant
believes that the bolts were in shipped product.
FSMA Fridays is sponsored by SafetyChain (safetychain.com) and The Acheson Group (www.achesongroup.com)

24. Q & A
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25. Thank you
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800-401-2239

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June 25, 2021
Rolando Gonzales, Vice President of Public Health