Presented by Christopher Snabes [Director, Food Safety @ The Acheson Group] Watch the replay of this presentation: https://info.safetychain.com/replay-enforce-fda-ia-rule Abstract: Understand the purpose, intent, and unique enforcement of the IA Rule, including the relationship between food safety and food defense requirements, what could result in a Form 483a, and how the IA Rule expands across the supply chain, both domestically and abroad. Learn essential tips to help you prepare ahead of a FSMA Food Defense audit, what the FDA expects a facility to have in a written food defense plan, and how to train your teams to identify Actionable Process Steps (APS) and proactively mitigate risks, including required management components.

1. FSMA Fridays Webinar Series
Monthly Industry News, Updates & Trends for Food, Beverage, & CPG Manufacturers
Christopher Snabes
Director, Food Safety
Preparing for the FDA’s Enforcement of
the Intentional Adulteration (IA) Rule

2. ✔Monthly FSMA Related News
✔Regulation Changes & Updates
✔Industry Trends
✔Q&A with TAG
What is FSMA Fridays?
A global food safety and public
health consulting group made up
of seasoned industry experts
Award-winning digital plant
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plant-wide performance and
better control quality, yield &
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Brought to you by:

3. Meet Your FSMA Friday Speaker
Christopher Snabes
Director, Food Safety
Christopher has over 20 years of experience in the food industry,
specializing in food microbiology and food safety. Before joining The
Acheson Group (TAG), Christopher was the Food Technical Specialist
for The American Proficiency Institute having extensive experience in
ISO documentation and its related quality procedures, and advancing
the Food Microbiology Proficiency Testing division with several
innovative improvements for customers.
IA VA Lead
INSTRUCTOR
One of under 100
FDA/FSPCA IA VA trained
instructors in the world

4. FSMA: Regulatory Updates
● FDA extends comment period for draft guidance chapters on hazard analysis,
risk-based preventive controls for human food. For Chapter 11: Allergens and
Chapter 16: Acidified Foods, originally released September 26, 2023, comments
now extended to May 24, 2024.
● The FDA will hold a one-day virtual public meeting on Data and Technology in
the New Era of Smarter Food Safety on April 24, 2024, from 10:00 am – 4:00 pm
EDT. The meeting is designed to help the agency improve its understanding of
how we can leverage data and technology to exponentially advance food
safety and achieve better health outcomes.
● The application window for the Voluntary Qualified Importer Program (VQIP)
portal for fiscal year FY 2025 benefits will close on May 31, 2024.

5. Quick Background on the Intentional Adulteration Rule
• Intentional adulteration is the deliberate contamination of food with a biological, chemical,
radiological, or physical agent by an individual or group of individuals with the intent to cause
wide scale public health harm.
• The Food Defense Rule is one of several rules within the framework of FSMA. The final rule:
“Mitigation Strategies to Protect Food Against Intentional Adulteration (21 CFR Part 121)”,
requires covered facilities to identify and protect their most vulnerable points against
intentional adulteration.
• Recognizes that the greatest threat to our Food Supply is from an “Inside Attacker”, someone
with legitimate access to the production floor.
• It is written to prevent or significantly reduce the likelihood of an Inside Attacker from
committing wide scale public health harm.

6. What Does It Cover?
FDA regulated foods in the following facilities that manufacture, process, pack or hold human food:
• Human Food Facilities, Domestic and International, currently regulated by FDA who follow FSMA
• For USDA/FDA Dual registered facilities, it only covers the FDA regulated foods being manufactured
• Acidified Foods
• Bottled Water
• Dietary Supplements
• Infant Formula
• Juice HACCP
• LACF
• Seafood HACCP
• Farms that produce Milk

7. • The agency allows flexibility in how the Food Defense Vulnerability assessment is conducted.
It must consider the following:
• Public Health Impact
• Degree of Physical Access to an Actionable Process Step, APS
• Ease of introduction of a contaminant at the APS
• Underlying assumption that it will be conducted by an Inside Attacker
Vulnerability Assessment is Key Step
• The KAT, 3 Element, and Hybrid methods meet these VA requirements
NOTE:
Any facility that currently relies only on a GFSI recognized Food Defense Plan and/or a USDA Food
Defense Plan is out of compliance!!!

8. • As of December 2023, the FDA has performed about 1,300 facility “Food Defense Quick
Checks”, at the end of an FDA Inspection, such as a Preventive Control Inspection, GMP
Inspection, etc.…
• Designed to be 30 to 45 minutes in length, with a present/absent, or yes/no approach to
compliance. No enforcement of the rule was implemented, and education about the IA
Rule and all its requirements was highly stressed.
Initial FDA Approach to IA Rule Implementation
Quick Checks:

9. Example Quick Check Questions
• Do you have a written Vulnerability Assessment?
• Have you Identified any Actionable Process Steps, APS?
• Have you identified Mitigation Strategies to protect the APS?
• Do you have Management Components in Place?
• Food Defense Monitoring
• Food Defense Verification
• Food Defense Corrective Actions
• Is it signed and dated by a Food Defense Qualified Individual?

10. Quick Check Results
• About 1300 facilities have gone through Quick Checks:
• ~ 200 facilities were not covered
• (Very Small Business < 10M $, or about 11.2 M $ today adjusted for inflation)
• Higher than what the FDA expected-but completely acceptable
• FDA expects this number to go down when facilities do their first 3-year re-
evaluation and choose to use the 3 Element or Hybrid method
• ~ 70% are using the KAT Vulnerability Assessment approach

11. Comprehensive Inspection Estimated to begin September 2024
• The agency has announced that they are targeting September 2024 as the start of
comprehensive enforcement of the IA Rule.
• The comprehensive approach will be a detailed review of the written food defense
plan and its implementation.
• Adequacy and appropriateness of identification of your APS will include a review of
your written rationale as to why each step, point, or process is, or is not, an APS.
• Implementation of the Food Defense Plan will also be assessed.
(Ask yourself: Are the food defense mitigation strategies working, and do you have records
of trained workers/supervisors at each APS, food defense monitoring, and food defense
verification?)

12. Consumer Safety Officers
• Initially, the agency will have a “Food Defense Inspection Team” consisting of 1 supervisor
and 5 highly trained CSOs.
• The CSOs will have vast experience in food manufacturing platforms, PC/Food Safety
enforcement experience, as well as in depth food defense training.
• The CSOs will issue two 482s upon arrival.
• As an example, the facility will be issued a 482 for food safety, open the investigation, then
close it out. They will then issue a second 482 for food defense, open the investigation,
and close it out.
• A single CSO will perform both inspections

13. Food Defense Inspection
• The reason for two 482s, is that food safety issues may be discovered while the CSO
is there for a food defense inspection. Many existing food safety/facility practices can
have a dual food defense function. Additionally, this may decrease the food
inspection burden on the facility and the agency.
• CSOs will be trained on a uniform determination of adequacy for consistency.
• The CSO will try to resolve issues with the facility in addressing any deficiencies while
discovered on site. CFSAN Food Defense SMEs will be available for real-time
consultation and technical support.

14. Pictures and Facility Documentation
• The agency will do everything it can NOT to take pictures
• If there is discussion while the CSO is on the floor and sees a potential APS or
mitigation issue and it cannot be resolved with the facility, the CFSAN Food Defense
SMEs will be contacted for a “screen share”, in rare instances and only if needed
• The agency will do everything it can NOT to collect Food Defense facility
documentation. Currently, the FDIT is developing SOPs for collection of food defense
documentation, only if necessary, and developing restricted access protocol on a
“need to know” basis only

15. Can 483a’s be Issued?
• Yes!
• Dual Inspection: Food Safety 483a and Food Defense 483a can be issued.
• If a facility refuses a CSO entry for food defense inspection, it will constitute an official Refusal
• A facility can get a 483a for food safety, if warranted, and a separate 483a for food defense,
if warranted.
• Food Defense 483a will have two parts:
• Public information: “Not following CFR Part 121.126”
• Facility only information, not public, as a separate appendix.
The appendix will list specific observations and only shared with the facility.
• Food Defense Warning Letters will have the same two parts

16. What Facilities Will be Inspected?
• The FDIT will work with existing agencies and if a site is due for an annual inspection, a FDIT
CSO will be assigned, based on priority.
• Conducted only on a limited number of prioritized facilities
• Focus inspectional resources on where IA concern is highest
• Prioritized facilities will be inspected first and determined using a “matrix” the agency
is still developing. Approximately 43 elements have inputs into the matrix. These
elements will not be issued to the public. One potential matrix element that the
agency discussed as an example, can be if a facility has been documented as
having an inadequate food safety plan, then it is typically expected the facility will
not have an adequate food defense plan and be a cause for inspection.

17. Closing Thoughts
• This is new regulatory territory for the agency. The agency is ensuring consistent food defense
evaluation by a CSO through rigorous training.
• Domestic and International facilities will be inspected.
• FDIT will increase number of CSOs over time, current thinking is about 15 CSOs. Currently, all
hired from within existing FDA staff.
• Long term goal is to have facilities on a 3-year cycle of inspections.
• CFSAN Food Defense SMEs are working with the National Conference on Interstate Milk
Shipment, NCIMS, on an SOP for inspecting farms that produce milk.
• FDQI Training is key for each segment of the IA Rule.
• An update by the Agency is expected sometime this spring.

18. FSMA FRIDAY
Questions?
Christopher Snabes
Director, Food Safety
Preparing for the FDA’s Enforcement of
the Intentional Adulteration (IA) Rule

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