FOOD ALLERGENS PRACTICAL REGULATORY ISSUES STEVEN GENDEL, PH.D. VP, DIVISION OF FOOD ALLERGENS IEH LABORATORIES AND CONSULTING GROUP
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1 FOOD ALLERGENS PRACTICAL REGULATORY ISSUES STEVEN GENDEL, PH.D. VP, DIVISION OF FOOD ALLERGENS IEH LABORATORIES AND CONSULTING GROUP 1
2 ROAD MAP Policy complexity Implementation complexity Communication complexity 2
3 POLICY COMPLEXITY Food Allergens are different The hazard is something which is nutritious and desirable for most of the population Risk mitigation = information Clear, complete, accurate labels 3
4 POLICY COMPLEXITY Factors that must be considered in formulating policy Public health Science Legal issues Social issues Cost (regulatory impact) Practicality (especially enforcement) 4
5 POLICY COMPLEXITY Policy formulation processes can be complex 5
6 POLICY COMPLEXITY Decision making under uncertainty can be difficult 6
7 POLICY COMPLEXITY Decision making under uncertainty is supported by using the risk analysis paradigm Risk Management Risk Communication Risk Assessment Hazard Identification Hazard Characterization Exposure Assessment Risk Characterization 7
8 POLICY COMPLEXITY Decision making under uncertainty supported by using the risk analysis paradigm The characteristics expected of a regulatory risk assessment are defined (in the US) by OMB, agency policies, and legal mandates Fully transparent Reproducible 8
9 POLICY COMPLEXITY Example Doing a regulatory risk assessment for establishing allergen thresholds would need to include: A data quality analysis for all data Full description of all input data Full description of all assumptions and defaults Full documentation of all steps in the analysis Explicit consideration of all sources of uncertainty and their impact Consideration of alternative models, not just the best fit Full presentation of results (not just summary statistics) Full discussion of data gaps Peer review and public comment 9
10 POLICY COMPLEXITY Risk assessment is a great tool for comparison and prioritization Not as good for isolated determinations Helps to identify relative importance of different variables/conditions 10
11 ROAD MAP Implementation complexity Communication complexity 11
12 IMPLEMENTATION COMPLEXITY Areas of impact for food allergens Bioengineered foods Food additives Food labeling (including exemptions) Preventive controls Retail and food service Recalls and reportable foods Legal authorities and standards differ for each 12
13 IMPLEMENTATION COMPLEXITY Examples Additives Individual substances Pre-market evaluation Labeling Whole foods and ingredients Post-market evaluation Preventive Controls Facilities Processes evaluated 13
14 IMPLEMENTATION COMPLEXITY Policies are useful only if compliance can be assessed. Are analytic techniques sufficiently accurate and reliable? Matrix effects Processing effects Cross reactions Multiple forms of an allergen Whey or casein or whole milk? Native or denatured or hydrolyzed or modified? 14
15 IMPLEMENTATION COMPLEXITY Sampling issues What is a representative sample? 15
16 IMPLEMENTATION COMPLEXITY Ingredient flow 16
17 ROAD MAP Communication complexity 17
18 COMMUNICATION COMPLEXITY Multidimensional communications Agency to agency Agency to industry Regulatory messages Agency to public Agency to health care providers Public health messages Health care providers to each other Health care providers to patients Clinical messages 18
19 COMMUNICATION COMPLEXITY Individual to individual communication More influential than messages from government agencies, medical bodies, or support organizations 19
20 ROAD MAP Are we there yet? 20
21 YOU ARE HERE Food allergens are essentially an emerging issue Our understanding of risk is evolving Public health agencies operate in a complex multifaceted environment It is appropriate to travel cautiously 21
22 WHERE TO NEXT? Some significant data gaps What do food allergic consumers actually eat? What do they think the various advisory labels mean? How do these labels affect purchasing and eating behaviors? What messages are they hearing from their medical advisors? What do they think about thresholds? How would industry practices change if there were thresholds? How frequent are allergic reactions? What factors lead to these reactions? 22
23 THANK YOU IEH Steven Gendel Vice President, Division of Food Allergens Bothell Way NE Lake Forest Park, WA p f Steven.Gendel@iehinc.com 23
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