Allergens

An example advisory statement is:

"Produced in a facility that processes peanuts, tree nuts, milk, eggs, fish, wheat, and soy."

Employee training should encompass what?

- Allergen awareness and control - Awareness of health hazards posed to consumers - Practices and procedures to prevent allergen cross-contact - Ongoing training to reinforce commitments to food safety and every employee's role in it

What factors should be taken into consideration when designing facilities to minimize the potential for allergen cross-contact?

- Traffic patterns or movement of employees - Air flow patterns - Workflows (manner that ingredients and finished product move through facility) - Physical barriers separating processing of allergen-containing foods

What are the three allergen labeling formats permitted by FALCPA?

1. Listing the allergen source in plain English in the ingredient list: "Rice, sugar, wheat, milk..." 2. Listing the allergen source in plain English in a parenthetical after ingredient name "sodium caseinate (milk), semolina (wheat), albumin (egg). 3. Listing the allergen source in plain English in a separate "contains" statement immediately after or adjacent to the list of ingredients, with a font size at least as large as the list of ingredients (e.g., "contains milk and soy.")

When was sesame added to the major allergen list?

2021

What is a food allergy?

A condition in which the immune system overreacts to a specific protein found in a food.

If possible, allergen-containing foods should be processed on what?

A dedicated line or system.

What is the difference between a food allergy and a food tolerance?

A food allergy is an overreaction of the immune system in response to a specific protein found in a food which can cause anaphylaxis and death. A food intolerance describes the difficulty of digesting a specific food.

What is food intolerance?

A medical condition describing when someone has difficulty digesting a particular food.

What is Anaphylaxis?

A serious allergic reaction that is rapid in onset, can cause death.

What is the FDA Food Code?

A technical and scientific guidance document for regulating retail food stores and retail food services.

What does FSMA specify about allergens?

Allergens are considered a human hazard likely to occur, and thus should be considered when establishing and implementing a food safety plan (hazard analysis & preventive controls).

How are allergens in manufacturing regulated?

Allergens in manufacturing are considered hazards likely to occur and must be addressed under the Hazard Analysis and Risk-Based Preventive Controls Rule (PC, as part of the Food Safety Modernization Act (FSMA).

Regarding allergens, what does the PC Rule specify?

Allergens must be considered when performing a hazard analysis and when drafting a food safety plan.

Describe the prevalence of food allergies in the U.S.

Approximately 4% of adults and 4-6% of children have a food allergy.

Reworked product containing allergens must be what?

Clearly identified to indicate the presence of allergens.

How many allergy-causing tree nuts are recognized by the FDA?

Close to 20, including Brazil nuts, almonds, coconuts, pistachios, macadamia nuts, cashews, pecans, and walnuts.

How have manufacturing equipment contributed to allergen recalls?

Equipment must be accessible and cleanable. Equipment that was not or could not be adequately cleaned have caused product recalls due to allergen cross-contamination.

How can the risk of allergen cross-contact during product changeover be reduced?

Equipment should be thoroughly cleaned. Labels should be monitored, documented, and verified.

Why are fish and crustacean shellfish considered separate allergen categories?

Fin fish (salmon, bass, flounder) antigens that cause a food allergic reaction will not necessarily activate a crustacean shellfish reaction (lobster, crab, shrimp).

What is the most common food allergies in adults?

Fish and crustacean shellfish

What is FALCPA?

Food Allergen Labeling and Consumer Protection Act, a law requiring the labeling of major food allergens in a standardized and consistent format. The FDA is the primary agency responsible for enforcing FALCPA.

What factors should be considered for raw ingredient allergen control?

If major allergens are brought into a facility as raw ingredients, consideration of storage and handling must be addressed in the Food Safety Plan.

In general terms, a food product is misbranded if what?

If the product is labeled in a false or misleading way.

Describe the food intolerance commonly associated with consumption of milk.

Lactose intolerance - the inability of a person to digest the sugar lactose.

Regarding food allergen labeling, what does FALCPA specify operators of food manufacturing facilities and retail stores must do?

Manufacturers and retailers must ensure that major food allergens and ingredients derived from major food allergens are accurately identified and labeled on finished, packaged products.

How do manufacturers communicate their allergen advisory statements?

Manufacturers can voluntarily print advisory statements such as "may contain" or "processed in a facility that" on labeling.

What are the most common food allergies in children?

Milk, egg, and peanuts

What are the major food allergens recognized by FALCPA?

Milk, eggs, fish, crustacean shellfish, tree nuts, peanuts, wheat, soybeans, sesame.

If a label lists the incorrect tree nut, fish, or crustacean shellfish, what is the product considered to be?

Misbranded and subject to recall

Can advisory statements be used in place of Good Manufacturing Practices?

No - procedures should be in place to eliminate cross-contact with allergen-containing ingredients.

Are molluscan shellfish included in the fish or crustacean fish category?

No, molluscan shellfish (oysters, mussels, clams, scallops) do not induce an allergic response in people who are allergic to fin fish or crustacean fish. Molluscan shellfish are not recognized in the big 9.

Where do allergen cross-contact events often occur?

On food processing equipment (mixers, conveyer belts, pipes, etc.)

What is the different between peanuts and tree nuts?

Peanuts are legumes, grown in the ground, and belong to the same family as peas and lentils, whereas tree nuts grow on trees.

What should be done if use of an allergen-product dedicated line or system is not possible?

Processing the allergen containing products last, and thoroughly cleaning equipment prior to the next run.

Regarding allergens, what should manufacturing personnel understand?

Proper hygiene, handwashing, glove use, using clean outer garments, and how to move through a facility.

What food products are exempted from applicable FALCPA requirements?

Raw agricultural commodities (fruits & vegetables) Foods sold at retail (unless packaged and possesses labeling for sale in interstate commerce) Highly refined (bleached, deodorized, etc.) oils derived from major food allergens Ingredients derived from highly refined oils (like peanut oil).

If possible, employees who handle allergens should be what?

Restricted from areas where foods that do not contain allergens are handled/processed.

What two US federal agencies oversee food labeling?

The FDA and the USDA.

What seven laws govern the FDA's regulatory food activities.

The Food and Drug Cosmetic Act The Fair Packaging and Labeling Act The Nutritional Labeling and Education Act The Dietary Supplement Health and Education Act The Food Safety Modernization Act The Food Allergen Labeling and Consumer Protection Act The Allergy Safety, Treatment, Education, and Research Act.

What three laws govern the USDA's regulatory food activities?

The Meat Inspection Act, The Poultry Inspection Act The Egg Products Inspection Act

According to the FDA Food Code, who is the designated "person in charge?"

The individual present at a food establishment who is responsible for the operation at the time of a regulatory inspection.

Describe the allergen label specificity required for tree nuts, fish, and crustacean shellfish.

The labels must specify the type of tree nut (walnut, pecan, etc.), fish (salmon, tuna, etc.), or crustacean fish (shrimp, lobster, crab, etc.).

What does "The Big 9" refer to?

The nine major food allergens accounting for the vast majority of foodborne allergic reactions.

According to the 2022 FDA Food Code, regarding allergens in retail, what must the person in charge be responsible for?

The person in charge shall ensure that all employees are properly trained in food allergy awareness, shall possess knowledge of what foods that are considered major allergens, and shall be able to recognize the symptoms that a major food allergen causes in sensitive individuals.

What is an allergen cross-contact?

The unintentional incorporation of a major food allergen into another food. Cross-contact events account for most food allergy reactions.

What is the cure for a food allergy?

There is no cure, strict avoidance of the allergen is the only means of preventing an allergic reaction.

What is the purpose of voluntary allergen advisory statements?

To alert consumers to the possible presence of food allergens.

Advisory statements must be:

Truthful and not misleading

What is the leading cause of food product recalls?

Undeclared allergens due to labeling errors. Approximately 1/3rd of foods reported to FDA's Reportable Food Registry as serious health risks are undeclared allergens.

Food allergy reactions are often the result of what?

Unintentional cross-contact between allergen-containing foods and foods that do not contain allergens.

How are allergens in retail regulated?

Via the FDA Food Code; however, to be used for a regulatory purpose, the FDA Food Code must be adopted as a regulation or ordinance by the state or local agency regulating retail food establishments.

What is product changeover and why is it risky?

When a manufacturing line transitions from processing one product to another. Changeover is a time when the risk of allergen cross-contact is greater.

What is rework?

When clean, unadulterated food that has been removed from processing for reasons other than unsanitary conditions, or that has been successfully reconditioned by reprocessing and is suitable for use as food.

What is allergen cross contact?

When one food or food residue containing an allergen comes into contact with another food and their proteins mix.

How can the behavior and actions of employees contribute to allergen cross-contact?

Workers who handle allergens can fail to follow prescribed processes, cut through production facilities, fail to wash hands, etc.

Does FALCPA allow exemptions for labelling allergens?

Yes - manufacturers can submit notification or petitions to the FDA to request labeling exemptions from an ingredient derived from a major food allergen (soy lecithin, fish proteins).