Food Allergen Testing, Management and Controls. Scott Radcliffe Technical Support Scientist Presented by: Ivy Cho Food Safety Area Sales Manager

Transcription

1 Food Allergen Testing, Management and Controls Scott Radcliffe Technical Support Scientist Presented by: Ivy Cho Food Safety Area Sales Manager

2 What is food to one may be bitter poison to others Lucretius (99-55 B.C.E.) De Rerum Natura

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4 Why Are Food Allergies a Concern for Industry? Consumer Safety Allergen-Free Market Food Allergens = Food Safety Risk

5 Source: FARRP, University of Nebraska FDA Food Allergen Recalls

6 USDA FSIS Food Allergen Recalls Source: FARRP, University of Nebraska

7 FDA Reportable Food Registry 2013 Entries Source: FDA Reportable Food Registry Fourth Annual Report, 5/2014

8 Food Allergy is Not Rare 4% of adults and 8% of children have a food allergy Rate of food allergy is increasing 200,000 emergency visits/yr for food allergy 38% of visits were children <18 years 44% of visits involved anaphylaxis On average, emergency dept. visit for food allergy every 3 minutes Source: Clark, et al. Frequency of US emergency department visits for food-related acute allergic reactions. J Allergy Clin Immunol: 3/2011.

9 Overview: Food Allergies and Intolerances

10 Food Intolerance Pharmacological Thiamine Metabolic Lactose Intolerance Idiosyncratic Sulfite Sensitivity

11 IgE mediated Food Allergy True food allergy Antibodies against food allergen proteins Cell mediated No antibodies involved T cell immune response Celiac Disease Treatment is avoidance diet

12 Food Allergy Symptoms Gastrointestinal Nausea Vomiting Diarrhea Skin Hives Swelling Dermatitis Respiratory Throat swelling Asthma Systemic Anaphylaxis

13 Anaphylaxis Shock reaction Loss of blood pressure and arrhythmia Can lead to organ failure Unless treated rapidly, can be fatal deaths/year

14 Celiac Disease Affects ~1% of population Result of consuming gluten from wheat, rye or barley Gluten is composite of two proteins, glutelin and prolamin Prolamin = gliadin (wheat), secalin (rye) or hordein (barley) Prolamin proteins not water-soluble Prolamins associated with immune reaction Glutelin is water-soluble, but less associated with immunoreactivity

15 Celiac Disease Inflammation in small intestine Lose ability to absorb nutrients, minerals, vitamins Symptoms Diarrhea Anemia due to iron deficiency Osteopenia and osteoporosis Fatigue and failure to thrive Source:

16 Food Allergen Regulations Food Allergen Labeling and Consumer Protection Act of 2004 Reportable Food Registry (RFR) Food Safety Modernization Act of 2011 (FSMA) FDA Gluten Free Labeling Rule 2013

17 Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA) Packaged foods, not raw agricultural goods Defines Big 8 major food allergens Labeling requirements for foods that are or contain ingredient that is MFA Common name must be listed in ingredients or contains statement If using contains statement, must list all MFA s present, even if already in ingredient list

18 Source: Virginia Cooperative Extension, publication AREC-55P

19 Reportable Food Registry (RFR) Covers foods regulated by FDA Website for submitting report when a food product may cause serious adverse health consequences Undeclared Big 8 allergens basis for report Must be filed within 24 hours of knowledge that food product may be affected Must investigate root cause

20 FDA Reportable Food Registry Entries by Allergen Source: FDA Reportable Food Registry Fourth Annual Report, 5/2014

21 FSMA and Food Allergens Establishes undeclared allergens as reasonably likely hazard Written plan for hazard analysis Preventive allergen control plan to ensure: Allergens accurately declared on label Correct label applied to product Prevention of allergen cross-contact

22 FSMA Allergens - What It Means to Industry Review & update allergen control programs Verify allergen info and preventive controls from ingredient suppliers Validate allergen sanitation procedures and document results Ensure all employees trained on allergen awareness and allergen control plan

23 FDA Gluten Free Labeling Rule Defines gluten-containing grains as wheat, rye and barley Gluten free label allowed for foods: That do not inherently contain gluten Proven scientifically to have <20 ppm gluten Containing ingredients from gluten-containing source refined to remove gluten to <20 ppm Not allowed for foods containing: Whole, gluten-containing grains Unavoidable gluten 20 ppm

24 Raw Material Handling & Storage Production Scheduling Prevent Cross- Contact During Processing Labeling & Packaging Controls Hygienic Design Supplier Monitoring Food Allergen Management Allergen Sanitation Product Development Allergen Monitoring Hazard Identification Source: FARRP, University of Nebraska Training & Education Validation & Verification

25 Hazard Identification FSMA written plan: identify and evaluate allergen hazards Generate allergen process flow diagram to map where allergens present in plant and introduced to process For each allergen hazard, evaluate likelihood and severity of risk Image Source: How Food Companies Can Modify Their Existing HACCP Plans into an All-Encompassing Food Safety Plan. Food Safety Magazine. 12/2015.

26 Peanut Doses Eliciting Adverse Reaction Percent of peanut allergic population who would react 0% 0.3% 1% 4.25% 14% 30% 50% Given 3 million Americans with peanut allergy, how many is this? , , , ,000 1,500,000 Sources: Ballmer-Weber, B. Clinical Studies for Allergen Dose Response. European Commission Research and Innovation: Second Workshop on Food Allergy. FARRP, University of Nebraska

27 Product Development Only use allergens when necessary for taste or functionality of product Know where existing allergens are and are not in facility factor into formulation and line choice Review new products with manufacturing before start up Avoid using allergenic minor ingredients

28 Supplier Verification and Monitoring Require supplier to provide: Allergen control plan Ingredient information form Allergen sanitation programs/protocols Allergen training records Written assurance that ingredients contain no undeclared allergens Must give notification of changes to ingredient allergen status prior to change

29 Raw Material Handling and Storage Review incoming material labels for allergen information Tag incoming material so allergen clearly and unambiguously visible Image Source: IAFP -allergen-icons/ Separate storage areas for allergenic and non-allergenic Dedicated containers, bins, pallets Store in clean containers with tightly closed lids Stage allergenic ingredients in separate and clearly marked area

30 Production Scheduling Best practice is to segregate manufacturing areas for allergenic and non-allergenic Not always possible, so reduce risk: Schedule non-allergenic before allergenic Schedule long runs of allergen-containing products to minimize changeovers Group products with same or similar allergen profiles together Add allergens progressively to line

31 Prevent Cross-Contact Storage Airborne particulate Staff Supply Chain Cleaning Packaging Allergen Cross-contact Transport Processing Aids Shared Equipment Raw material handling Re-work Source: UK Food Standards Agency, 2006

32 Allergen Labeling Must indicate Big 8 allergens on label in plain English May contain statements not addressed by law Overused, and limit options for allergic consumer Not a substitute for GMP Only use when allergen presence is documented, sporadic, uncontrollable and potentially hazardous to consumer

33 Allergen Labeling Review labels for accuracy Destroy obsolete labels after any update Design controls can reduce human error e.g., different colored package for different formulations of same product Controls to ensure formulation and label match Visual comparator UPC reader Automated vision inspection system

34 Hygienic Design Equipment must be self-draining and easy to clean effectively Smooth surfaces without sharp corners, crevices, dead zones

35 Allergen Sanitation Goal is to remove allergen residue from product zone and adjacent areas to prevent cross-contact to subsequent production Define SSOP: Equipment that will be cleaned Disassembly and cleaning instructions Tools, chemicals, concentrations Sanitation personnel safety Verification and documentation

36 Allergen Detection Methods ATP swab Protein swab Immunoassay PCR Mass spectrometry

37 ATP Swab Energy transport molecule found in all living cells Rapid & inexpensive, requires luminometer Result correlates with surface cleanliness ATP is not a protein or allergen Negative ATP test Negative for allergen protein

38 Protein Swab Rapid, inexpensive Chemical rxn with protein residue causes color change from green to purple Since allergens are protein, better indicator allergens removed than ATP Non-specific, less sensitive than allergen immunoassays

39 Immunoassays Allergen-specific, very sensitive Detects using antibodies against specific allergen protein Quantitative (ELISA) or qualitative (LFD) Can be used for both cleaning verification and validation (ingredients, finished product also)

40 Enzyme-linked immunosorbent assay (ELISA) Quantitative Some additional lab equipment, experience/training necessary min test time Sample result extrapolated from standard curve Can test raw ingredient, finished product, swabs, rinses

41 Lateral flow device (LFD or strip test) Qualitative: > or < LOD Rapid time to result (11 min) No or little additional equipment Does not require lab

42 Allergen HACCP Validation and Verification Understand allergen load and physical form Develop SSOP for each line & allergenic ingredient Validate using allergen-specific tests Verify SSOP performed as designed based on understanding of allergen: Visually clean ATP swab Total protein swab

43 Allergen HACCP Validation Validate SSOP 1. Run allergenic product on line 2. Test equipment while dirty for pos. control (may need to dilute for specific LFD test) 3. Perform the SSOP 4. Test surfaces or rinse water using swabs for allergenspecific test 5. Redo validation cycle if allergen non-detect both times, SSOP validated 6. Validate allergen control plan by testing finished product 7. Revalidate periodically, and whenever anything changes Source: Taylor, S. Effective Food Allergen Management. FARRP Workshop, 2016.

44 Training and Education Train all staff on allergen awareness and basics of allergen control plan More in-depth training on allergen control plan depending on roles/responsibilities Knowledge evaluation Document the training

45 Raw Material Handling & Storage Production Scheduling Prevent Cross- Contact During Processing Labeling & Packaging Controls Hygienic Design Supplier Monitoring Food Allergen Management Allergen Sanitation Product Development Allergen Monitoring Hazard Identification Source: FARRP, University of Nebraska Training & Education Validation & Verification

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47 Thank you!