OOD ALLERGIES 

Causes immune response 

o Canbe ~ 

Response due to exposure to allergenic Ingredients 

Harmless to some - dangerous to others 

NOTE: The "Big 8" food allergens are good examples of 

some of the most common allergens of public health concern. 

FOOD INTOLERANCES 

Often confused with allergic reactions 

Generally do not result in life-threatening reactions 

**Examples - See above list 

11092021 

Food Ingredients of Public Health Concern 

This document has been created to be used for reference purposes only. The 

information in this document is not all-inclusive. Please refer to the FSIS directives and 

notices for detailed policy and procedural information. 

The “Big 8” Food Allergies 

o Milk 

o Eggs 

o Fish (e.g. Bass, Cod or Flounder) 

o Crustacean shellfish (e.g., Crab, Lobster, or Shrimp) 

o Tree nuts (e.g., almonds, pecans, or walnuts) 

o Peanuts 

o Wheat 

o Soybeans 

Examples of Food Ingredients People May be Intolerant to: 

1. Lactose 

2. Sulfites 

3. FD&C Yellow No. 5 (Tartrazine) 

4. Monosodium Glutamate 

5. Gluten 

6. Nitrates 

7. Nitrites 

COMPARISONS 

RTE/SS Self-Paced Inspection Course 
 

 

 

 

 

 

 

 

11092021 

Responsibilities 

Establishments must: 

• research all ingredients used in production of its products. 

• determine if an ingredient may trigger food allergies in sensitive individuals. 

• must employ appropriate food safety procedures – ensure ingredients added to 

product match the product formula. 

• ensure all ingredients are properly listed on the product label. 

Establishments must also: 

• prevent cross-contact between products, equipment and utensils that do and 

do not contain allergens; Cross-contact could result from inadequate 

control or inappropriate use of ingredients of public health concern. 

• make sure the label on the products that do contain allergens ha the correct 

declarations on it; accidental application of inaccurate labels to properly 

formulated products could pose a threat to consumers sensitive to any 

ingredients in the formulation. 

• effectively implement the food safety system procedures, they must control 

allergens on an ongoing basis. 

NOTE: Highly refined edible oils (soybean oil and peanut oil): 

o results from processing that involves de-gumming, neutralizing, 

bleaching, and deodorizing extracted oils. This process removes 

undesirable chemicals, giving a uniform color and eliminating undesired 

odors. This process makes the oil virtually free of allergenic proteins. This 

makes the refined edible oils safe for individuals in the food-allergic 

population to consume. 

o The “cold press” extraction of oils from plant materials may not remove 

all protein. These oils are rarely used at this time. 

FYI – When allergen-containing products are cooked or oar-fried in highly refined edible 

oils, they may leave traces of allergenic proteins behind in the oil. Establishments 

that reuse the same oil to cook or par-fry a variety of products should consider 

the potential hazard such reuse might pose to food-allergic consumers. 

RTE/SS Self-Paced Inspection Course 
 

 

 

11092021 

Label Declarations 

Federal Meat Inspection Act (FMIA) + Poultry Products Inspection Act (PPIA) -> all 

ingredients used to formulate meat or poultry products generally must be declared in the 

ingredient statement on the product label. 

o A product that contains ingredients that are permitted but not declared on 

product labeling = misbranded 

o Any ingredient should be declared by its common or usual name in the 

ingredients statement. 

Voluntary Statements 

The agency allows establishments to use statements on the labels of their finished 

products that will alert people who have sensitivities or intolerances to the presence of 

specific ingredients. This allows consumers to avoid those products. 

Example: “Contains: milk, wheat gluten, soy” or a product label might specify – 

“Contains sodium caseinate (from milk) to alert milk allergic consumers that the 

ingredient is derived from milk. 

Factual Labeling Statements 

These statements provide information about a product’s manufacturing environment to 

the consumer. 

Example: “Produced in a plant that uses peanuts,” or “may contain” statements like, 

“may contain peanuts,” on meat and poultry product labeling. 

NOTE: This type of statement should only be used in cases when an 

establishment can show that GMPs and Sanitation SOPs cannot 

reasonably be expected to effectively eliminate the possibility of crosscontact of products with ingredients of public health concern. 

These statements can only be used in cases where establishments show 

that adequate Sanitation SOPs cannot effectively eliminate the potential for 

cross-contact. The statements must be evaluated and approved by the 

Labeling and Program Delivery Staff (LPDS) on a case-by-case basis. 

Inspection Program Personnel Responsibilities 

Establishments have preventive measures and controls to address all potential 

chemical hazards, including food allergens and other ingredients of public health 

concern. 

RTE/SS Self-Paced Inspection Course 
 

 

 

 

11092021 

If a meat or poultry establishment ships product containing an undeclared allergen 

into commerce, its food safety system has failed. 

Establishment may have failed due to: 

• Address an allergen as a potential chemical food safety hazard in its hazard 

analysis 

• Failed to support the decisions made in the hazard analysis 

• Failed to effectively implement controls supporting the decisions made in the 

hazard analysis 

Recalls 

Recalls connected to undeclared allergens may be due to reasons, including: 

• Changes in ingredient suppliers 

• Suppliers changing ingredient formulations 

• Finished meat or poultry products in the wrong package 

• Misprinted labels applied to finished meat or poultry products 

• Changes to the ingredient formulation of the meat or poultry products without a 

corresponding change in the labeled ingredients. 

• A meat or poultry product coming into contact with an undeclared allergenic 

ingredient not directly added to the product. 

The Big 8 Formulation Verification Task 

This task is used to verify that: 

• establishments are accurately controlling and labeling the eight most common 

food allergens. 

• the appropriate label is the label being applied to the product. 

• the applied label is consistent with the establishment’s label approval on file. 

FSIS Directive 7230.1, The Big 8 Formulation Verification Task covers how to perform 

this task. IPP are encouraged to review the directive and regulations prior to 

implementing this task. While performing the task, IPP should: 

o Review records 

o Observe production processes 

o Respond to specific task-related questions in PHIS 

This is a routine, priority 3 task that appears on a monthly basis on the PHIS 

Establishment Task List. It should be performed on each shift. 

RTE/SS Self-Paced Inspection Course 
 

 

 

 

 

 

11092021 

o After selecting a product, you should obtain the specific product 

formulation for that product from the establishment. 

o IPP perform the Big 8 Formulation Verification task using a combination of the 

recordkeeping and review and observation inspection components for the 

verification of the selected product. Performing the task involves: 

 Reviewing product formulation records and observing product formulation 

process steps to verify that all ingredients used in the production of the 

product are consistent with the intended product formulation. 

 Reviewing the product label to verify that all ingredients used in 

formulating the product are declared in the ingredients statement by 

common or usual name and in descending order of predominance. IPP 

should never assume that all ingredients used in a product formulation 

are appropriately declared on the final meat or poultry product labels. 

This task can be performed more often as a directed task, if there are any indications of 

increased risk of undeclared allergens in the establishment. 

The task must be scheduled in advance. So, you can determine which products are 

being produced on the day you plan to perform the task. 

• Coordinate with the IPP on the other shift , so that you can avoid selecting the 

same product for a task. 

• In establishments that produce more than one product, IPP are to use the chart on the 

next page to prioritize a product for the verification task. 

• You must determine if the establishment produces products in any of the HACCP 

processing categories other than slaughter that may contain any of the Big 8 

food allergens. 

• If the establishment does produce any products that contain one or more of the 

Big 8 food allergens: 

o Review the preventive and control measures developed by the 

establishment. 

o Verify that these measures are being implemented effectively. 

o Verify the product labels are consistent with the product formulation 

records. 

IPP are to apply the priority list to all products in an eligible establishment 

whether the establishment produces products containing a “Big 8” allergen. 

NOTE: If this task does not apply to the operations in a given establishment, based on 

the criteria in FSIS Directive 7230.1 -> you should find the task on the Establishment 

Profile/Inspection Tasks page for that establishment and disable the task. 

RTE/SS Self-Paced Inspection Course 
All Establishment Products 

Priority 1: Have one or more of 

the products had a change In 

supplier of ingredients, a 

change in ingredients, or a 

change in formulation within 

the past six months? 

Priority 2: Do one or more of the 

products Incorporate a multiingredient component 

produced outside the 

establishment? 

• If only one product has a 

change, use this product for 

verification; 

• If multiple products had a 

change, use the product 

produced in the largest 

volume. 

• If only one product 

incorporates a component, 

use this product for 

verification; 

• If multiple products 

incorporate a component, 

use the product produced in 

the largest volume. 

If the prioritization does not result in a single product, IPP are to choose the product 

produced in the largest volume. IPP are to avoid selecting the same product for 

consecutive tasks as described in section V.E. 

11092021 

FYI: The establishment can address the allergens within its HACCP plan, Sanitation 

SOPs and/or a Prerequisite Program. 

RTE/SS Self-Paced Inspection Course