Food Allergen Testing, Management and Controls

Scott Radcliffe

Technical Support Scientist

Presented by: Ivy Cho

Food Safety Area Sales Manager

“What is food to one may be

bitter poison to others”

Lucretius (99-55 B.C.E.)

De Rerum Natura

Why Are Food Allergies a Concern for Industry?

Food Allergens = Food Safety Risk

Allergen-Free Market

Consumer Safety

Source: FARRP, University of Nebraska

FDA Food Allergen Recalls 1988 - 2015

Source: FARRP, University of Nebraska

USDA FSIS Food Allergen Recalls 1999 - 2015

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

FDA Reportable Food Registry 2013 Entries

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.

Overview: Food Allergies and Intolerances

Food Intolerance

• Pharmacological

– Thiamine

• Metabolic

– Lactose Intolerance

• Idiosyncratic

– Sulfite Sensitivity

Food Allergy

• IgE mediated

– True food allergy

– Antibodies against food allergen proteins

• Cell mediated

– No antibodies involved

– T cell immune response

– Celiac Disease

• Treatment is avoidance diet

Food Allergy Symptoms

• Gastrointestinal

– Nausea

– Vomiting

– Diarrhea

• Skin

– Hives

– Swelling

– Dermatitis

• Respiratory

– Throat swelling

– Asthma

• Systemic

– Anaphylaxis

Anaphylaxis

• Shock reaction

• Loss of blood pressure and arrhythmia

• Can lead to organ failure

• Unless treated rapidly, can be fatal

• 150 – 200 deaths/year

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

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: www.nutritiopedia.com

Food Allergen Regulations

• Food Allergen Labeling and Consumer Protection Act of 2004

• Reportable Food Registry (RFR) - 2009

• Food Safety Modernization Act of 2011 (FSMA)

• FDA Gluten Free Labeling Rule – 2013

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

Source: Virginia Cooperative Extension, publication AREC-55P

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

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

FDA Reportable Food Registry 2009-2013 Entries by Allergen

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

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

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

Food Allergen

Management

Raw Material Handling &

Storage

Labeling & Packaging Controls

Production Scheduling

Prevent Cross-Contact During

Processing

Allergen Sanitation

Supplier Monitoring

Hazard Identification

Validation & Verification

Training & Education

Allergen Monitoring

Hygienic Design

Product Development

Source: FARRP, University of Nebraska

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.

Sources: Ballmer-Weber, B. Clinical Studies for Allergen Dose Response. European Commission Research and Innovation: Second Workshop on Food Allergy. FARRP, University of Nebraska

Peanut Doses Eliciting Adverse Reaction

0 9000 30,000 127,500 420,000 900,000 1,500,000

0% 0.3% 1% 4.25% 14% 30% 50%

Percent of peanut allergic population who would react

Given 3 million Americans with peanut allergy, how many is this?

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

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

Raw Material Handling and Storage

• Review incoming material labels for allergen information

• Tag incoming material so allergen clearly and unambiguously visible

• 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

Image Source: IAFP https://www.foodprotection.org/resources/food-allergen-icons/

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

Allergen Cross-contact

Storage

Raw material handling

Transport

Staff

Cleaning

Packaging

Processing Aids

Supply Chain

Re-work

Airborne particulate

Shared Equipment

Source: UK Food Standards Agency, 2006

Prevent Cross-Contact

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

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

Hygienic Design

• Equipment must be self-draining and easy to clean effectively

• Smooth surfaces without sharp corners, crevices, dead zones

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

Allergen Detection Methods

• ATP swab

• Protein swab

• Immunoassay

• PCR

• Mass spectrometry

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

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

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)

• Quantitative

• Some additional lab equipment, experience/training necessary

• 45-120 min test time

• Sample result extrapolated from standard curve

• Can test raw ingredient, finished product, swabs, rinses

Enzyme-linked immunosorbent assay (ELISA)

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

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

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 allergen-specific 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.

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

Food Allergen

Management

Raw Material Handling &

Storage

Labeling & Packaging Controls

Production Scheduling

Prevent Cross-Contact During

Processing

Allergen Sanitation

Supplier Monitoring

Hazard Identification

Validation & Verification

Training & Education

Allergen Monitoring

Hygienic Design

Product Development

Source: FARRP, University of Nebraska

Thank you!

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