1. Food Allergen Recalls – What are the Root Causes and What Can Be Done to Mitigate the Risk?
Joe Baumert, Ph.D.
Associate Professor
Co-Director, Food Allergy Research & Resource Program (FARRP)
Department of Food Science & Technology
University of Nebraska-Lincoln, USA
Midwest AOAC Meeting
Lincoln, NE
June 6, 2018

2. Food Allergies Affect 3-4% of the U.S. population
4-8% of children
1-2% of adults
Reactions can be life-threatening
Reactions are preventable!
Small amounts can cause reactions
(mg or low ppm total protein)
No current treatment:
Must follow complete avoidance diets
Burden on Consumers & Public Health Concern
U.S. childhood food allergy:
$24.8 billion annual economic impact
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3. Reportable Food Registry
A web-based portal for submitting a report whenever there is reasonable probability that the use of, or exposure to, an article of food will cause serious adverse health consequences or death to humans
Report within 24 hrs of receipt of knowledge that a food product might be involved
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4. 2013-2014 FDA Reportable Food Registry
Continued to see an increase in allergen-related entries (47%, up from 43.6% in 2012)
Bakery (cookies, muffins & cakes) and chocolate/confections accounted for 37/95 entries (39%)
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5. FDA Food Allergen Recall Incidents: 1988-2018
FSIS/ USDA Food Allergen Recalls:
* Includes FDA recalls & alerts
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6. Food Allergen Recalls: Causes
Review of FDA allergen recalls FY FY (Gendel and Zhu 2013)
Identified 732 allergen recalls
Gendel, S.M. and J. Zhu. Journal of Food Protection, (11): p
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7. FMI Foundation Grant
FARRP obtained a small grant from the FMI Foundation to identify the root causes of labeling errors made in food allergen recalls and industry best-practice procedures
Project duration: 2.3 months ending October 31, 2017
Obtained allergen recall publically available data from FDA and USDA-FSIS for 2015 and 2016
Surveyed companies involved in allergen recalls for information on root causes and preventive actions
Surveyed FARRP member companies on best practices for allergen control
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8. FMI Foundation Grant Root Cause Survey:
237 surveys ed October 11, 2017 with an reminder sent again after one week
90 personal s
147 generic company s
4 companies not allowed to fill out survey due to company policy
1 company permanently closed
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9. FMI Foundation Grant FARRP Member Survey:
199 surveys ed October 11, 2017 with an reminder sent again after one week
FARRP is a food industry-funded consortium with 93 member companies (at the time); primarily food manufacturers or ingredient suppliers
Multiple surveys sent to some companies
Some also received Roots survey due to recalls
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10. 2015-2016 FDA Food Allergen Recalls
1,593 total recalls involving 439 companies
Unable to determine specific reason for over 700 FDA recalls (details not reported online)
Peanut in cumin accounted for at least 323 recalls
Peanut in wheat flour accounted for at least 142 recalls
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11. Food Allergen Recalls: Trends
Recent Recall Episodes
Issues
: Peanut in Cumin
Imported, ground cumin with very high levels of peanut
Potentially economically motivated adulteration in overseas supply chain
Other cumin sources: potential low- level commodity co-mingling
2016: Peanut in Wheat Flour
Wheat flour from mill in Georgia with moderate levels of peanut
Potential root cause: cross-contact during transportation
Supplier verification
International supply chains
Commodity transportation
Commodity comingling
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12. 2015-2016 FDA Regulated Foods Accounting for Recalls
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13. 2015-2016 Reasons for FDA Regulated Food Allergen Recalls
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14. 2015-2016 USDA Food Allergen Recalls
95 total recalls involving 92 companies
Unable to identify any true root cause or overall reason for error from USDA data
Peanut in cumin accounted for at least 14 recalls
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15. 2015-2016 USDA Regulated Foods Accounting for Recalls
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16. 2015-2016 Reasons for USDA Regulated Food Allergen Recalls
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17. Root Causes Survey 10 initial respondents, 7 finished entire survey
2 FARRP member companies finished Roots survey
Need to continue to seek additional survey completions
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18. Root Causes Survey – Corrective Actions
QC made corrections on how new material is received, labeled and separated
Reassess electronic labeling database
Better identification of similar recipes
Update packaging inspection SOP’s and training to ensure packaging matches allergens
Corrective labeling
Retrain employees
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19. FARRP Member Company Survey
44/45 companies have an Allergen Management Program
38/39 companies provide training on allergen awareness to all employees
other company provides training to select employees
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20. Survey Summary
Absence of good explanations of reasons for food allergen recalls in many cases in USDA and FDA recall reports
Appears varying degrees of information provided by company and/or required by FDA or USDA on reasons for recalls
Perhaps not all root causes of recalls can be identified but general reasoning helpful to learn from mistakes of other companies
More survey respondents needed
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21. Preliminary FDA Analysis of Recalls: 2017-2018
No allergen labeling
Manufacturer failure to declare all the ingredients in a formulation
Food mislabeled as wrong product
Allergen cross-contact
Jenny Scott (2018); US FDA presentation at Health Canada/FARRP Food Allergen Methodologies Conference, Toronto, Canada.
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22. International Approaches to Use Thresholds & Risk Assessment
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23. Current Status of Regulatory Thresholds
Public health authorities have not established regulatory action levels for any of the allergenic foods
With the exception of Japan (10 µg/g protein limit for labeling)
Labeling laws/regulations in many countries impose a zero threshold for source labeling of ingredients
Food industry and regulators are acutely aware of allergens
How much allergenic residue is too much OR how clean is clean enough?? (Remember it is impossible to assure zero risk with anything in life)
With little or no guidance on action levels/thresholds, extensive use of precautionary/advisory labeling (“may contain”) currently exists
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24. Food Allergen Thresholds
Clinical data exist on individual threshold doses of various allergenic foods from oral challenges conducted for diagnosis, threshold trials, and immunotherapy trials – published and unpublished
Individual threshold data can be used to statistically model the population threshold distribution for allergenic sources
*Note: data from food-allergic individuals rather than extrapolation from animal models as in classical toxicological approaches
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25. ED10 = 3.8 mg peanut protein
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26. The VITAL 2.0 ® base on ED01 or lower 95% confidence interval of the ED05
Expected to protect 97-99% of the allergic population
ED01 = 0.2 mg peanut protein
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27. VITAL® Reference Doses
Allergen
mg Protein Level
Peanut
0.2
Milk
0.1
Egg
0.03
Hazelnut
Soy
1.0
Wheat
Sesame
Crustacean shellfish
10.0
Mustard
0.05
Other Tree Nuts
Based upon the ED01 for peanut, milk egg and hazelnut
Based upon the 95% LCI of ED05 for the remaining 5 allergens
Other tree nuts based upon the hazelnut reference dose
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28. Current Status of Reference Doses
Instituted by VITAL in 2012
Endorsed by ILSI-Europe in 2014 and iFAAM in 2017
Overall benchmark approach endorsed by US FDA (2006) and EuroPrevall (2007)
Unofficially used by several public health agencies in several countries (UK FSA, CFIA, FDA on case-by-base basis)
Similar approach adopted by different branches of the Dutch, Belgian or German authorities albeit each with their own different reference doses
Continued questions by regulatory authorities has led to continued datamining and risk assessments for various inputs in the risk assessment
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29. Quantitative (Probabilistic) Risk Assessment
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30. Risk Assessment
a function of the exposure dose (mg of protein from the allergenic source) compared to the threshold dose (mg of protein from the allergenic source)
Quantitative risk assessment can evaluate the risk on an individual or population basis
Exposure Dose < Threshold Dose = no predicted reaction
Exposure Dose ≥ Threshold Dose = a predicted reaction
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31. Key Components of a Risk Assessment: Primary Input Parameters:
Understanding where UAP may occur
Understand your vulnerabilities
Tracking allergens
Clinical threshold data from low-dose food challenges
*Note: data from food-allergic individuals
Exposure Assessment
Food intake/consumption (g; quantity & frequency)
Level of contamination (µg/g or ppm; & frequency)
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32. Secondary Risk Assessment Input Parameters
Prevalence of the Food Allergy
Market Share for Specific Product in Category
Number of Packages of Food Manufactured
Propensity to Buy Advisory Labeled Products
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33. Quantitative (Probabilistic) Risk Assessment
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34. Quantitative (Probabilistic) Risk Assessment……
Iteration #5,000,000
Amount
6 g
Concentration
1000 ppm
Dose
6 mg
Threshold
10 mg
Iteration #1
Amount
40 g
Concentration
3 ppm
Dose
0.12 mg
Threshold
0.5 mg
Iteration #2
Amount
110 g
Concentration
30 ppm
Dose
3.3 mg
Threshold
10 mg
Iteration #3
Amount
260 g
Concentration
300 ppm
Dose
78 mg
Threshold
25 mg
Iteration #4
Amount
50 g
Concentration
10 ppm
Dose
0.5 mg
Threshold
10 mg
Calculate risk of predicted allergic reaction during a single eating occasion (%)
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35. Exposure Assessment: Food Consumption Data
Must ensure that the consumption estimates are reflective of the entire population of consumers
portion size
mean (average) consumption amount
P75 of food consumption distribution
maximum consumption amount (very conservative)
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36. Exposure Assessment: Contamination Data
The concentration of allergenic food residue (or protein from the allergenic source) can be determined either by calculation or by quantitative analysis
Quantitative analysis commonly conducted on ingredients or finished food products that may contain an unintended allergenic residue
Ideally the analytical method used to determine the concentration of the unintended allergic residue would detect proteins from the allergenic source (rather than DNA or ATP)
There are important difference in target proteins that are detected and report units
(ppm WHAT???)
Commodity (e.g. NFDM)
Total protein from the allergenic source (e.g. total milk protein)
A certain protein fraction from the allergenic source (e.g. casein or whey)
A specific allergen (e.g. α-casein or β-lactoglobulin)
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37. Which ELISA Is More Sensitive?
An ELISA with a sensitivity limit of 2.5 ppm NFDM?
An ELISA with a sensitivity limit of 1.0 ppm BLG?
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38. Which ELISA Is More Sensitive?
BLG is approx. 10% of total milk protein
So, 1 ppm BLG is equivalent to 10 ppm milk protein
But milk protein is about 35% of NFDM
So, 1 ppm BLG is equivalent to 28.6 ppm NFDM
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39. Risk Assessment Example 1 RTE Popcorn
Calculation of Milk Protein in Ready-To-Eat Popcorn
Ingredient
% Milk protein in flavor
% Flavor in slurry
% Milk protein in slurry
Milk protein in slurry (ppm)
% Slurry on popcorn
% Protein in formula
ppm allergen in formula
Butter Flavor %
5.00% %
0.13
16.00% %
Serving Size ( g)
Allergen protein per serving (g)
Allergen protein per serving (mg)
VITAL action level for milk (mg)
Amount of product achieving VITAL action level (g) 31
0.1
5,000.00
76.3
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40. Quantitative Risk Assessment Consumption Analysis
Popcorn Consumption Estimates Using the NHANES Dietary Surveys
Food Product Category
# of Individuals Who Reported Consuming the Product Category
Estimated % of U.S. Population that Consume the Product Category
Consumption Estimates Per Eating Occasion (g)
Average
90th Percentile
95th Percentile
99th Percentile
Ready-To-Eat Popcorn
500
1.5% 30 77 83 85
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41. Quantitative (Probabilistic) Risk Assessment
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42. Quantitative Risk Assessment Results
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43. Quantitative Risk Assessment Results
Quantitative Risk Assessment of the RTE Popcorn that Contains 0.02 ppm Milk Protein Residue.
Product
Allergen Analyzed in Risk Assessment
ppm in Protein in Finished Product
User Risk
Milk Allergic Population
Overall Population
RTE Popcorn
Milk
ppm Milk Protein
# of Reactions per # of Milk Allergic Users (%)
# of Reactions per # of Milk Allergic Consumers (%)
# of Reactions per # of Individuals in the U.S. (%)
0.02 ppm
8.0 per 10 million ( %)
1.3 per 100 million ( %)
1.3 per 10 billion ( %)
*User Risk: assumes that all individuals consuming RTE popcorn are milk-allergic which is a very conservative assumption and likely overestimates the true risk of allergic reaction occurring upon consumption of these products.
**Milk Allergic Population: assumes that 1.5% of the milk-allergic individuals consume RTE popcorn on any given eating occasion.
***Overall Population: assumes that 1.0% of the population is milk-allergic and 1.5% consume RTE popcorn on any given eating occasion.
The most sensitive 1% of the milk allergic population would need to consume 5 kg of popcorn during a single eating occasion to reach their threshold dose. This is 58x the consumption of the 99 percentile consumers
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44. Conclusions
QRA and reference doses could be used advantageously by regulatory authorities to determine:
determine which ingredients from allergenic sources need to be labelled by source (FALCPA notifications)
curtail excessive use of precautionary labelling
determine the degree of risk posed by undeclared allergens in recall situations
assess the effectiveness of preventive allergen controls (FSMA)
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45. Thank You for Your Attention
Joe Baumert, Ph.D.
Food Allergy Research & Resource Program
Department of Food Science & Technology
University of Nebraska
farrp.org
© 2018