chapter(10 food$allergen$preventive...

Chapter 10

FOOD ALLERGEN PREVENTIVE CONTROLS FOR HUMAN FOOD

Food Allergen Preventive Controls Objectives (cont’d) (Slide 10-‐1 a)

• Include only allergen preventive controls that are identified in the hazard analysis requiring a preventive control

• If different food allergens are handled at the same time§ Allergen cross-‐contact may be the prevention

• If food allergens are in a product§ Allergen labeling may be the prevention

10-‐1Instructor’s Notes

When is an Allergen Control a Preventive Control? (Slide 10-‐2 a)

• Some facilities use icons to identify ingredients containing food allergens. This can usually be managed as a GMP rather than a preventive control. Focus resources on what matters most.

• The term “sanitation” may include both cleaning and sanitizing activities. § Cleaning is necessary to control allergens.§ Sanitizing is intended to kill microorganisms. Sanitizing has little or no impact on allergens.


Tree Nuts [Section 201 (qq)] – may be revised(Slide 10-‐3 a)

CommonCOMMON/USUAL NAME (used for declaration of specific type of nut)

Almond Chestnut (Chinese, American, European, Seguin)

Hickory nut Pili nut

Beech nut Chinquapin Lichee nut Pistachio

Brazil nut Coconut Macadamia nut/ Bush nut

Sheanut

Butternut Filbert/hazelnut Pecan Walnut (English, Persian, Black, Japanese, California), Heartnut, Butternut

Cashew Ginko nut Pine nut/Pinon nut

10-‐3

Source: http://www.fda.gov/ForIndustry/FDABasicsforIndustry/ucm238807.htm(accessed November 17, 2017)

Other Countries (Slide 10-‐3 b)

• Canada http://www.inspection.gc.ca/food/information-‐for-‐consumers/fact-‐sheets/food-‐allergies/eng/1332442914456/1332442980290accessed November 17, 2017

ALLERGEN ALLERGENEggs SoyMilk WheatPeanuts MustardTree nuts SesameSeafood (Fish, crustaceans, shellfish)

Sulphites (>10 ppm): not a true allergen

10-‐3

Other Countries (cont’d) (Slide 10—3 c)• Europehttp://www.eufic.org/article/en/expid/EUFIC_Review_on_Food_Allergens/ accessed November 18, 2017

ALLERGEN ALLERGENEggs Molluscn shellfish

Milk and products Cereals containing gluten

Peanuts Mustard

Nuts (almonds, hazelnut, walnut, cashew, pecan, brazil nut, pistachio, macadamia, Queensland nuts)

Sulphur dioxide and sulphites (>10 ppm): not a true allergen

Fish Sesame seeds

Crustacean Celery

Soybeans Lupin

10-‐3

Other Countries (cont’d) (Slide 10-‐3 d)• Others

Country ALLERGENAustralia Molluscan shellfishJapan BuckwheatOthers Barley, rye

10-‐3

Allergen Preventive Controls Requirements (cont’d) (Slide 10-‐4 a)

• For accurate allergen labeling of finished food, also be aware of§ Formulation mistakes§ Ingredient substitution§ Supplier producing several allergen containing ingredients§ Undeclared allergens as a major cause of food recalls.

• Need supply-‐chain program for a supplier that produces several allergen containing ingredients, such as nuts.


June 20, 2017JFC International Inc. issues missing English label resulting in no allergy alert because of undeclared wheat, soybean, and fish (Bonito) in Futaba Sesame Hijiki Rice Seasoning.No illnesses have been reported.

Source: http://www.fda.gov/Safety/Recalls/

June 20, 2017United Natural Foods, Inc. (UNFI) issues a recall of a single production batch of Fat Cat Purry-‐Purry Sauce Hot Sauce because an ingredient supplier, Woodland Foods of Chicago, IL, notified Fat Cat Gourmet Foods that there was a possible peanut contamination in the peri-‐peri peppers used. No illnesses have been reported.

Source: https://www.fda.gov/Safety/Recalls/ucm563889.htm(accessed July 3, 2017)

Allergen Cross-‐contact Prevention Considerations (cont’d) (Slide 10-‐5 a)

Prevent cross-‐contact by:• Not processing different food allergens at the same time or at

all• Not having conflicting schedules with other operations• Managing allergens as a prerequisite program or a preventive

control• Keeping track of allergens from receiving to finished product• Training employees to make them understand the seriousness

of allergens

How the facility manages their system and the complexity of their allergen concerns will determine if above are PC or prerequisite program. All of the above must be documented.

10-‐5

Equipment Cleaning (cont’d) (Slide 10-‐6 a)A Potential Preventive Control for Allergens

• In the absence of established allergen thresholds, thorough cleaning means no visible residue at a minimum (visually clean).

• Validation of allergen cleaning procedures may be useful, desirable, or strongly encouraged:§ If cleaning procedures need to be adjusted§ The first time a unique allergen is introduced for a complex equipment on a production line

§ When major changes are made to product formulation.


Equipment Cleaning (cont’d) (Slide 10-‐6 b)A Potential Preventive Control for Allergens

• Validation results are recorded in Sanitation Record or Allergen Scheduling Record

• Validation helps to protect your business and the consumer’s health

• Ways alternative to equipment cleaning § Color-‐coding or labeling equipment—see handouts in my website

§ Using physical barrier (walls, curtains, partitions) between production lines in close proximity

§ Training of staff


Verification of Allergen Cleaning (cont’d) (Slide 10-‐7 a)

• No need to validate visually clean if met• During changeovers, “Push Through” material may be

used to establish safe times and volumes• Adenosine triphosphate (ATP) tests and protein swabs

may not detect low levels of allergens that cause allergenic reactions but indicate effectiveness or extent of cleaning. ATP is the molecule that most cells use as their main energy.

• Enzyme-‐linked ImmunoSorbant Assays (ELISA) and Polymerase Chain Reaction (PCR) are more sensitive and can detect food allergens at the molecular level levels.

• Testing of all allergens is now possible.


Examples of Test Kits (not an endorsement) (Slide 10-‐7 b)

• Neogen: Almond, β-‐Lactoglobulin (BLG), casein, cashew, crustacean, egg, gliadin/gluten, hazelnut, lupine, mustard, peanut, pecan, pistachio, sesame, soy, total milk, walnut

• Elisa Technologies: Gluten and gliadin• Hygiena: Gluten, shrimp, wheat, peanut, egg, milk, soy, almonds, sesame

• R-‐Biopharm, Inc.: crustaceans, egg, fish, milk, lupine, sesame, soy, celery, gliadin/gluten, nuts

10-‐7

Examples of Test Kits (not an endorsement) (cont’d)(Slide 10-‐7 b)

• CrystalChem: β-‐lactoglobulin, buckwheat, casein, egg, gluten, peanut, soy

• Elution Technologies: almond, casein, Brazil nut, cashew, coconut, crustacean, egg white, fish, hazelnut, macadamia nut, mollusk, mustard, peanut, pecan , pine nut, pistachio, sesame, soy, walnut

• BioFront Technologies, Inc.: Coconut, soy, almond, peanuts, tree nuts, lupin, egg, mustard, sesame, gliadin, casein,

• Romer Labs Inc.: almond, β-‐lactoglobulin, casein, curstaceans, gluten, lupin, peanut, tree nuts, sesame, soy

10-‐7

Scheduling or Run Sequencing (cont’d) (Slide 10-‐8 top a)

• If an allergen present in a product is not in the next product scheduled to run, run product with the unique allergen last. For example, if not using dedicated lines, run § Vanilla ice cream first§ Then ice cream with added pecans§ Then ice cream with added pecans and almonds§ Execute a sanitation protocol: End result must be “allergen clean.”

• If possible, only run products with the same allergen profile on the same production line.

• “Allergen clean” indicates thorough cleaning between products containing different allergen profiles (builds awareness among operators on purpose of cleaning).

• Example of a Production Line Allergen Assessment for the E.G. Food Company follows.

10-‐8 topInstructor’s Notes

Manufacturing and Engineering Controls (cont’d) (Slide 10-‐9 bottom a)

• Watch for overhead conveyor spilling product onto a conveyor below

• Be aware of transfer via aerosols and dust when water sprays or air hoses are used

• Physical barriers (e.g., curtains, walls) may be necessary to separate processing lines

• Reused water or oil may have the potential for cross over§ DO NOT REUSE unless sophisticated tests demonstrate that there is no carryover

10-‐9 bottom

Maintenance and Engineering (cont’d) (Slide 10-‐10 a)

• Easily cleaned and inspected in all areas• Use dedicated tools in areas with allergens to keep from spreading the residue

• May require a hygienic zone (Appendix 6)

10-‐10

Allergenic Ingredient Control (cont’d) (Slide 10-‐11 a)

• Must be the current list (inform supplier to inform you of changes!)

• Check packaging, processing aids, colors, flavoring, lubricants, spices

• May be done by the person in charge of tracking formulations

10-‐11

Al-‐Aware http://www.al-‐aware.com/labels.html

IAFP http://www.foodprotection.org/resources/food-‐allergen-‐icons/

Icons (Slide 10-‐11 b)

Icons can be useful especially when different languages are spoken. You may develop your own for consider using those already available. 10-‐11

Source: http://al-‐aware.com/products.html

Colored Icons and Labels (Slide 10-‐12 top a)

10-‐12 top

Labeled Bins Containing Allergens (Slide 10-‐12 top b)

10-‐12 top

Source: http://al-‐aware.com/products.html

Storage of Incoming Goods (cont’d)(Slide 10-‐12 bottom a)

• Storage can present an allergen cross-‐contact issue if not managed effectively

• Those with allergens on the bottom rack must be separated from others without allergens on the bottom rack (just in case of accidents)

• The level of control needed depends on the standard practices implemented in the facility.

10-‐12 bottomInstructor’s Notes

Colored Signage and Tags (Slide 10-‐12 bottom a)

EGGS ALLERGENEGGS SHELLFISH

ALLERGENSHELLFISH

DAIRY ALLERGENDAIRY

FISH ALLERGENFISH

SOY ALLERGENSOY

TREENUTS

ALLERGENTREENUTS

WHEAT ALLERGENWHEAT

PEANUTS ALLERGENPEANUTS

10-‐12 bottom

Allergen Cross-‐contact Prevention During Processing (cont’d) (Slide 10-‐13 a)

• Allergen cross-‐contact applies to material OPEN to the environment. If in closed containers, GMP is usually adequate to manage allergen cross-‐contact issues.

10-‐13Instructor’s Notes or Textbox

Dedicated and Designated Utensils (Slide 10-‐13 b)

Color-coded and labeled

Yellow = Dairy Green = Wheat Blue = Fish Red = Shellfish

10-‐13

Rework and Product on QA Hold (cont’d) (Slide 10-‐14 a)

• Marking rework with allergens§ Name of rework of QA hold product§ Name of allergen§ Date/time of manufacture§ Date/time put into storage§ Date/time for using rework§ Label containers appropriately§ Document amount of rework, when and where used

• Rework is for “exact into exact” applications.• I do not encourage rework.

10-‐14

Personnel Practices (cont’d (Slide 10-‐15 a)

• Leave outer garments at the entrance to the processing area during breaks

• Refrain moving employees from working in allergen-‐free areas to those with allergens

• Control traffic flow• Disposable gloves must be discarded immediately• Training is essential!

10-‐15

Allergen Labeling Considerations (cont’d) (Slide 10-‐16 top a)

• The right label on the package of the right product• Supply-‐chain program of ingredients and packaging

10-‐16 top

Product Labeling and Packaging

• Proper package labeling protects:§ Consumers

o Only way for them to know the allergen is in the product

§ Companieso Product recalls (leading cause of recalls)o Regulatory inquiryo Potential liability

• Preventive controls for food labels and packages are as important as other food allergen management techniques!Not naming allergens or naming the wrong allergens on labels and using the wrong labels on packages are the leading cause of allergen recalls.

10-‐16 bottom

Considerations for Food Labels and Packages

• Allergen labeling errors are a primary cause of food product recalls

• Consider controls that:§ Ensure accurate printing§ Ensure the right label or package is used for the product§ Manage formula changes to ensure that the correct label is used during transition

NOTE: Ensuring that the right label or package is applied to the right product is an allergen preventive control in most facilities.

10-‐17 bottom

Allergen Label Design Control Examples (cont’d)(Slide 10-‐18 top a)

• Some consider design and copy proofreading a preventive control

• Use color coding of printed labels and packages• No co-‐mingling of labels and pre-‐printed packages on the same pallet during shipping

10-‐18 top

“May Contain” Labeling (cont’d)(Slide 10-‐18 bottom a)

• Precautionary labeling (e.g., “may contain” “manufactured in a facility that produces…,”)§ Is NOT a preventive control§ Is NOT required § Is NOT a substitute for appropriate GMPs

• Confusing to consumers• FALCPA does not specifically address this issue• I do not encourage the use of precautionary labeling.

10-‐18 bottomInstructor’s Notes

“May Contain” Labeling (cont’d)(Slide 10-‐18 bottom b)

• Receiving establishment must§ Determine how to handle allergen labeling requirements § Document in the receiving establishment’s supply-‐chain program

• Potential resources for determining labeling options (also listed in your manual)§ FDA’s Guidance for Industry listed in Additional Reading§ The Food Allergy Research and Resource Program (FARRP)http://farrp.unl.edu/

10-‐18 bottom

Allergen Preventive Controls for Labeling (cont’d) (Slide 10-‐19 a)

• Ensuring correct label on the right product with allergen is an allergen preventive control§ But some may manage allergen labeling as a process control step and call it a CCP

§ WHAT IS IMPORTANTà the allergens present in the food are declared on the label

• All measures that are used are included in the Food Safety Plan.

• Effective to use continuous monitoring (review) during a processing run, e.g., bar code scanner (rejects wrong label)


Allergen Preventive Controls for Labeling (cont’d)(Slide 10-‐19 b)

• Colored striping is useful when the label supply runs out during production

• Do not mix unused packaging materials with other packaging materials in the warehouse

• Train line personnel to ensure product labels are switched properly at product changeover§ Especially important when labels are applied to product held in unlabeled inventory (e.g., brites, cans) then labeled well after production


Allergen Preventive Controls for Labeling (cont’d)(Slide 10-‐19 c)

• Remove and destroy out-‐of-‐date labels and packaging in a timely manner

• Keep accurate inventory records of labels and packaging

• Stage packaging so that only those needed for current product are in the packaging area

• Check packaging film labels or electronic label file for accuracy before using§ Compare label with product formulation§ Only authorized personnel may edit electronic label files


PRODUCT: Omelet – Plain, Cheese and Cheese Biscuit PAGE 18 of 38PLANT NAME: E.G. Food Company ISSUE DATEADDRESS: 360 Culinary Circle, Mytown, USA SUPERSEDESIngredient Allergen Assessment

E.G. Food Company Example

Raw Material Name Supplier

Allergens in Ingredient FormulationAllergens in Precautionary

LabelingEgg Milk Soy Wheat

Tree Nut (market name) Peanut

Fish (market name)

Shell-‐fish (market name)

Whole, liquid pasteurized egg

Your Egg Co.

X None

Grade A pasteurized milk

A Local Dairy

X None

Pan release oil, ABC Brand

My distributor

X None

Salt, XYZ Brand My distributor

None

Buttermilk biscuit

Flaky Co. X X None

American cheese

Cheesy Co.

X None

NOTE: If the supplier uses precautionary labeling, last column helps E.G. Food Company to identify allergens that are in their products. Also checks identity of the ingredient received.

Step 1: Check label upon receipt (Slide 10-‐20 top)

10-‐20 top

PRODUCT: Omelet -‐ Plain PAGE 1 of XPLANT NAME: E.G. Food Company ISSUE DATEADDRESS: 360 Culinary Circle, Mytown, USA SUPERSEDES

Allergen Label Verification Upon Receipt and Application to Product

Product Allergen Statement Label Number

Plain Omelet Contains: Egg, milk, and soy P 082015

Cheese Omelet Contains: Egg, milk, and soy C 082015

Cheese Omelet Biscuit Contains: Wheat, egg, milk, and soy B 082015

E.G. Food Company Example

NOTE: Allergen Preventive Control => (1) check the label upon receipt from the label manufacturer and (2) check the label number before applying to the CORRECT product

Checking label number is a less detailed review than reading “contains” statements and easier to do.

Step 2: Check label number before using. (Slide 10-‐20 bottom)

10-‐20 bottom

PRODUCT: Omelet -‐ Plain PAGE 1 of X

PLANT NAME: E.G. Food Company ISSUE DATESUPERSEDES

mm/dd/yymm/dd/yyADDRESS: 360 Culinary Circle, Mytown, USA

Allergen Control Hazard(s) Criterion

Monitoring Corrective Action Verification RecordsWhat How Frequency Who

Receiving packaging (labeled carton)

Undeclared allergens –egg, milk, soy (wheat in biscuit only)

All finished product labels must declare the allergens present in the formula per listing

Ingredient listing and allergen informa-‐tionmatches product

Visual check of carton label to match product formula

Before release to production

Label coordi-‐nator

If label is incorrect, reject labels and return to supplier or destroy. Identify root cause and conduct training as needed to prevent recurrence

Review of Label verification, Corrective Action and Verification records within 7 working days

Allergen Label Verifica-‐tion listing;Allergen Label Verifica-‐tion log;Corrective Action records;

E.G. Food Company ExampleAllergen Preventive Control Example – Label review upon receipt (Step 1) (Slide 10-‐21)

NOTE: includes review of allergen declaration and ingredient statement (or product formulation). Monitoring portion of Allergen Preventive Control is the same as that for Process Preventive Control.

10-‐21

PRODUCT: Omelet -‐ Plain PAGE 1 of X

PLANT NAME: E.G. Food Company ISSUE DATESUPERSEDES

mm/dd/yymm/dd/yyADDRESS: 360 Culinary Circle, Mytown, USA

Allergen Control Hazard(s)

Para-‐meter

Monitoring Corrective Action Verification RecordsWhat How Frequency Who

Fill,weigh, label

Undeclared allergens –egg, milk, soy (wheat in biscuit only)

All finished product must have correct labeled carton

Label number matches product

Visual check of carton number to match product

Beginning and end of run and when label stock is changed

Fill line opera-‐tor

If label is incorrect, segregate product, inspect back to the last good check, relabelproduct; Identify rootcause and conduct training as needed to prevent recurrence

Review of Label Check, Corrective Action and Verification records within 7 working days

Allergen Label Verification listingAllergen Label Check Log;Corrective Action records; Verification records

E.G. Food Company ExampleAllergen Preventive Control Example – Label review at application on product (Step 2) (Slide 10-‐22)

NOTE: Some consider only label application as their Preventive Control (Step 2).

10-‐22

Allergen Control by Suppliers (cont’d)(Slide 10-‐23 a)

• Supplier is the manufacturer or producer of the ingredient or product (21 CFR 117.3)§ Ask supplier to alert you when they make changes in the ingredient or product you purchase

§ If there are many allergens from one supplier, audit supplier

§ For example, some natural flavors might have allergens

10-‐23

QUESTIONS?

How to Read a Preventive Controls Form• Process control: What is your preventive control? For Process

Preventive Control, this may be your CCP.• Hazard: What is the hazard (B, C, P)?• Critical Limits: At what parameters and values could you

control the hazard?• Monitoring: How do you know you meet those parameters

and values? What is monitored? How is it monitored? How frequently? And who does the monitoring?

• Corrective Action: If you don’t meet the parameters and values, you have a deviation. What do you do to control the process again?

• Verification: How do you know all the previous monitoring and corrective actions were done?

• Records: What records do you have to demonstrate all the monitoring, corrective actions, and verifications were done and the food is safe?

Exercise

Examples -‐-‐ Language Used for Preventive Controls Form

• Corrective Action§ Hold product to the last good check and determine product

disposition§ Identify root cause and conduct measures to prevent recurrence

o Training may be needed§ Evaluate any affected food for safety§ Prevent affected food from entering commerce

• Verification§ Review of Cook log, Corrective Action records, Verification

Records within 7 working days§ Daily accuracy check for thermometer§ Annual calibration of thermometer

• Records§ Use records mentioned in the above (don’t forget

validation studies)See also Slides on 10-‐21 and 10-‐22

Exercise

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