This webinar will provide insight into how the food-allergic community views precautionary allergen statements, and how the industry can start to regain their trust by taking a risk-based approach to finished product labeling.

1. FSMA Fridays Webinar Series
Monthly Industry News, Updates & Trends for Food, Beverage, & CPG Manufacturers
The Psychology of Product Allergen Labeling
Brent Kobielush, Ph.D.
Director of Food Safety, The Acheson Group- TAG
February 25, 2022

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)
✔Only panelists are displayed
✔Recording link will be shared
✔Audio issues: use call-in number
Watch prior FSMA Friday recordings at
safetychain.com > Resources > FSMA Fridays
Before We Get Started
FSMA FRIDAYS

4. Featured FSMA Friday Speaker & Host
FSMA FRIDAYS
Aaron Bolshaw
CMO
Brent Kobielush, PhD
Director, Food Safety
● Previous Manager of Toxicology for General Mills (2009-15) and
Director, U.S. Regulatory Affairs at Cargill, Inc. (2015-21), where he
led the rollout of the Food Safety Modernization Act (FSMA) across
~500+ facilities, globally
● Member of SOT, IFT, IAFP, and governor-appointed member of the
Minnesota Food Safety and Defense Task Force (MNFSDT)
● Former Secretary of the Toxicology and Safety Evaluation Division
at IFT, and President of the Northland Regional Chapter and Food
Safety Specialty Section at the SOT
● BS (Chemistry) from Bethel University, MS and PhD from University
of Rochester School of Medicine and Dentistry in Toxicology

5. FSMA FRIDAYS
1. Have you become complacent? Are you audit-ready? FDA announced on
February 7, 2022 that it would “resume conducting domestic surveillance
inspections across all commodities…”
2. In a January 31st update, the FDA proposed the completion of several
guidance documents by the end of 2022.
3. Sesame has been added to the list of priority allergens by the US FDA –
compliance goes into effect in January 2023 – are you ready?
FSMA Updates

6. FSMA FRIDAYS
Living with Food Allergens is Life-Altering
Bullying Anxiety Depression Uncertainty/Risk
Food allergies: the
psychological toll
(nature.com)

7. FSMA FRIDAYS
• Adolescence
• Bullying, risk-taking
• Many don’t attend birthday parties
• Mistrust
• Family
• Friends
• Retail
• Food Companies
• Labels…especially Precautionary Allergen Labeling (PAL)1,2
Uncertainty and Risk are Driven by Several Factors
1Hefle, Susan L., et. al. J. Allergy Clin. Immunol., 2007.
2DunnGalvin, A. C., et. al., European J. of Allergy and Clin. Immunol., 2015.

8. FSMA FRIDAYS
FALCPA Requires Labeling, but Does Not Address Precautionary
Allergen Labeling (PAL)
SnackSafely.com
PAL

9. FSMA FRIDAYS
The Food Allergic Community Views PAL Differently
Regulated Mandatory
Legal
ramifications
Variations
represent a
hierarchy of risk
Allergen present
consistently at
low levels
2DunnGalvin, A. C., et. al., European J. of Allergy and Clin. Immunol., 2015.

10. FSMA FRIDAYS
Proliferation of PAL Leads to Further Uncertainty and Risk
1Hefle, Susan L., et. al. J. Allergy Clin. Immunol., 2007.
2DunnGalvin, A. C., et. al., European J. of Allergy and Clin. Immunol., 2015.

11. FSMA FRIDAYS
QA and Sanitation Need to Be Involved at the Beginning
Idea
Conceived
Ingredients
&
Formulation
Pilot Plant
Start Up
Sustain
Involvement…Here

12. FSMA FRIDAYS
• Whether the presence of a major food allergen is documented through
visual examination or analytical testing of the processing line, equipment,
ingredient or product, or other means;
• Whether the risk of presence of a major food allergen is unavoidable even
when current good manufacturing practices are followed;
• Whether a major food allergen is present in some, but not all, of the
product; and
• Whether the presence of a major food allergen is potentially hazardous.
*All guidelines need to be met to utilize PAL
PAL Should Follow the Food Allergy Issues Alliance Guidelines*
Food Allergy Issues Alliance, “Food Allergen Labeling Guidelines,” May 2001.

13. FSMA FRIDAYS
Labeling in Lieu of GMPs is Against the Law…
“Pixie Dust”
Ingredients
Right Thing
for the Allergic
Consumer

14. FSMA FRIDAYS
“It’s so scary when your child
has an allergy because it’s
literally a life-or-death
situation—you can’t
substitute something else.”
Consumers with food allergies: A growing market remains underserved |
McKinsey, 2020

15. Q & A
FSMA FRIDAY

16. ✔ FSMA Friday Session Recordings & Content Library
✔ TAG Newsletter
✔ Global Food Safety Consultants
AchesonGroup.com
✔ FSMA Friday LinkedIn Group
✔ Q&A, Articles & Updates … Join FSMA FRIDAYS!
Resources & Future Events
FSMA FRIDAYS
March 2, 2022: Three Key Methods to Unlock Continuous Improvement
March 17, 2022: Leveraging OEE to Minimize Downtime and Maximize
Performance
March 25, 2022: FSMA Friday with Ranjeet Klair