Ingredients of Public Health Concern 

7/3/2017 

Food Ingredients of Public Health Concern 

Objectives 

1. List the “Big 8” food allergens. 

2. List examples of food ingredients that some individuals are intolerant to. 

3. Distinguish between food allergy and food intolerance. 

4. Describe establishment responsibilities for controlling ingredients of 

public health concern. 

5. Identify situations that could lead to cross-contact with a food allergen. 

6. Identify situations that could lead to mislabeling of a product containing 

an ingredient of public health concern. 

7. Distinguish between labeling requirements and voluntary labeling 

declarations for ingredients of public health concern. 

8. Explain when an establishment can include factual statements about a 

product’s processing environment on the product label.

9. Describe how to perform and document the Big 8 Formulation 

Verification task. 

10. Describe additional labeling concerns that should prompt IPP to perform 

a directed General Labeling task and document general labeling 

noncompliance. 

Reference 

FSIS Directive 7230.1 Ongoing Verification of Product Formulation and Labeling 

Targeting the Eight Most Common (“Big 8”) Food Allergens

Introduction 

Formulations of many meat and poultry products may include ingredients that 

pose a health risk to individuals who are allergic or otherwise intolerant to the 

ingredient. Food allergens are of particular health concern; however, FSIS is 

equally concerned about all foods or food ingredients that may cause adverse 

health effects in individuals intolerant to certain ingredients. FSIS has long 

maintained the need for adequate in-plant ingredient controls and appropriate 

labeling of all ingredients by common or usual name. Nevertheless, there have 

been far too many meat and poultry product recalls due to the non-declaration of 

ingredients of public health concern on product labels. 

In this module, we discuss the significance of food allergens and other food and 

color additives of public health concern. We will discuss establishment 

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responsibilities regarding adequate control of food allergens and other 

ingredients of public health concern and accurate labeling of products containing 

food allergens or other ingredients of public health concern. We will also cover 

the work methods IPP use to verify that an establishment is meeting these 

responsibilities and the actions taken by IPP when an establishment fails to meet 

these important public health responsibilities. 

NOTE: FSIS has not established a comprehensive list of ingredients to which 

consumers have reported adverse reactions, and this handout should not be 

taken to represent a comprehensive list. Attachment 1 to FSIS Directive 7230.1 

lists examples of ingredients and products that may be derived from the Big 8 

food allergens. Several of the Additional Resources listed at the end of this 

handout provide similar information to help consumers in identifying allergenic 

ingredients in foods and may be useful to IPP. 

Food Allergies 

Some individuals suffer from food allergies, which are immune responses to 

certain food ingredients. These ingredients, called food allergens, are harmless 

to most people. However, some people have a hypersensitive immune system 

that responds aggressively when exposed to the allergenic ingredient. It is the 

immune system’s aggressive response that is harmful, not a direct harmful effect 

from the ingredient. Symptoms of food allergies can include a tingling sensation 

in the mouth, swelling of the tongue and throat, difficulty in breathing, hives, 

vomiting, abdominal cramps, diarrhea, a drop in blood pressure, loss of 

consciousness, and, in severe cases, death. Severe, life-threatening allergic 

responses are called anaphylactic reactions. 

The FDA has defined the eight foods below and any ingredients that contain 

protein derived from these eight foods as major food allergens. 

 Milk 

 Eggs 

 Fish (e.g., bass, cod, or flounder) 

 Crustacean shellfish (e.g., crab, lobster, or shrimp) 

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

 Peanuts 

 Wheat 

 Soybeans 

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These are often referred to as the “Big 8” food allergens, because they account 

for approximately 90% of food allergies. Within the “Big 8,” the two products that 

account for most food allergies are peanuts and crustacean shellfish. 

According to the FDA, millions of Americans suffer from food allergies each year. 

Many reactions are mild and likely go unreported. However, food allergies can 

cause severe, life-threatening reactions. The FDA estimates that food allergies 

result in 30,000 emergency room visits, 2,000 hospitalizations, and 150 deaths 

each year. While reactions can be treated, there is no cure for food allergies. 

Consumers with a food allergy must try to prevent reactions by strict avoidance 

of foods containing the allergen. To do so, these consumers rely on accurate 

labeling of food products. 

For most known food allergens, there is no conclusive scientific evidence that 

can be used to establish a minimum threshold level necessary for a food allergen 

to cause an adverse reaction. For any sensitive individual, though, an allergic 

reaction is potentially catastrophic. Consequently, in most cases, the presence of 

an undeclared substance that is a known allergen, in even a trace amounts, 

could pose a significant public health risk. 

Food Intolerances 

Some individuals may be intolerant of certain food additives and color additives. 

Food intolerances are often confused with allergic reactions, but the adverse 

effects of food intolerances do not involve the same immunological mechanisms 

as an allergic reaction. Food intolerances generally do not result in lifethreatening reactions like food allergies; however, they are still of public health 

significance, and FSIS is equally concerned about all food ingredients that may 

cause adverse health effects. 

Some people experience gastrointestinal disturbance when they drink milk. 

Often, the gastrointestinal disturbance is not an allergic reaction to milk proteins 

but intolerance to lactose, a sugar molecule in milk and milk products. People 

intolerant to lactose are generally deficient in lactase, the enzyme that breaks 

down lactose in the intestinal tract. As people get older, their lactase levels tend 

to decline. In individuals with insufficient levels of lactase, bacteria in the intestine 

break down lactose, which produces gas, bloating, cramping, and sometimes 

diarrhea. It is not just whole milk that is the problem for these individuals, as a 

variety of food products may contain milk derivatives that contain lactose. 

Sulfites, including sulfur dioxide, sodium sulfite, sodium bisulfite, potassium 

bisulfite, sodium metabisulfite, and potassium metabisulfite, have been used as 

food preservatives. One of the main uses of sulfiting agents is to prevent 

browning of processed fruits, vegetables, and shellfish. Sulfites are not used 

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directly on meat or poultry products, but other ingredients added to meat or 

poultry products may contain sulfites. 

People who have an intolerance to sulfites can experience symptoms including 

chest tightness, hives, stomach cramps, diarrhea, and breathing problems. The 

underlying mechanisms for sulfite intolerance are not completely understood. For 

some individuals, though, the sensitivity to sulfites may be an allergic type of 

response. People with asthma appear to be at an increased risk of having 

asthma symptoms following exposure to sulfites. 

The presence of sulfiting agents must be declared on the label if their 

concentration in the finished meat or poultry food product is 10 ppm or higher. 

However, some finished meat and poultry food products may be comprised of 

multiple separate components, e.g., potatoes or apple cobbler in a frozen dinner. 

For these products, if a separate component contains 10 ppm or more sulfiting 

agents, the sulfiting agents must be declared even though the total product 

contains less than 10 ppm of sulfiting agents. When sulfiting agents are required 

to be declared on a label, they must be (1) declared by their specific name or as 

“sulfiting agents,“ and (2) listed in the ingredients statement in order of 

predominance or at the end of the ingredients statement with the statement, 

“This Product Contains Sulfiting Agents“ (or the specific name of the sulfite 

compound). 

FD&C Yellow No. 5, or tartrazine, has been used as a color additive in a variety 

of food products. Some consumers appear to have an intolerance to tartrazine. In 

these consumers, tartrazine may cause symptoms similar to an allergic reaction, 

i.e., hives and swelling, but the reaction is not considered a true allergy. 

Tartrazine was also thought to be associated with the onset of asthma attacks, 

but more recent scientific evidence indicated tartrazine was an unlikely cause of 

asthma symptoms. To help protect people who may be intolerant to tartrazine, 

the FDA requires that any food for human use that contains Yellow No. 5 must 

specifically declare it as an ingredient. 

Monosodium Glutamate (MSG) is included as a flavor enhancer in a number of 

meat and poultry products. Some individuals have reported headaches, chest 

tightness, nausea, diarrhea, and sweating following consumption of products 

containing MSG. There is scientific debate over whether MSG causes adverse 

health effects in individuals. Nonetheless, given the significant consumer concern 

about this ingredient, FSIS urges companies to ensure that its use is properly 

declared in labeling. 

Gluten is the protein found in cereal grains, including wheat, barley, rye, and 

oats. It is what helps give dough its elasticity. Some individuals have a condition 

known as celiac disease, which is basically intolerance to gluten. Although it is 

not an allergic reaction, it does involve immunological mechanisms that result in 

inflammation and damage to the lining of the small intestine. Persons with celiac 

Inspection Methods 34-4 
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disease experience fatigue, bloating, cramping, chronic diarrhea, and nutrient 

malabsorption. FSIS permits statements highlighting the presence of certain 

gluten containing ingredients. If an establishment wishes to make a special claim 

that a meat or poultry product is gluten-free, then it must be able to support that 

special claim. 

Nitrate and nitrites are different compounds, both of which are composed of 

nitrogen and oxygen. They are used as curing agents in many meat and poultry 

products, including hotdogs, bologna, salami and other processed meats. These 

compounds contribute to the characteristic cured flavor and reddish-pink color of 

cured products. They are also important in inhibiting the growth of Clostridium 

spp. These compounds may cause headaches and hives in some people. In 

excessive amounts, nitrate or nitrite can be toxic. In addition to labeling 

requirements, the amount of nitrite or nitrate added to a product is restricted by 

regulation. 

Some products that traditionally include nitrite or nitrate can be manufactured 

without the use of added nitrite or nitrate. Such products are formulated to only 

include naturally occurring sources of nitrite or nitrate, such as celery juice 

powder, parsley, cherry powder, beet powder, spinach, or sea salt. Such 

products must be labeled appropriately. For example, an “uncured” bacon 

product should include a declaration such as “Uncured Bacon, No Nitrates or 

Nitrites added except those naturally occurring in___" on the product label. In 

addition, such products generally must bear the statement "Not Preserved, Keep 

Refrigerated Below 40°F At All Times," as the naturally occurring sources of 

nitrite or nitrate do not inhibit the outgrowth of Clostridium spp. to the same 

extent as the highly purified chemical forms. Exceptions to this refrigeration 

handling statement would be finished products that have been dried according to 

other requirements or that contain a sufficient amount of salt to achieve an 

internal brine concentration of 10% or more. 

NOTE: FD&C coloring agents, like Red No. 3 and Red No. 40, are often added to 

cure mixes as a tint to distinguish nitrite from salt. FSIS policy has always been 

that since the coloring agent does not function as a color additive in the meat or 

poultry product, it is considered to be incidental and does not require declaration 

on the product label. 

Establishment Responsibilities 

As part of conducting its hazard analysis, it is the responsibility of the 

establishment to research all ingredients used in the production of its products 

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

FSIS expects establishments to employ appropriate food safety procedures (i.e., 

HACCP plans, Sanitation SOPs, or other prerequisite programs) for ensuring that 

ingredient addition appropriately matches the product formula and that all 

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ingredients are properly disclosed on the product label. The establishment must 

implement measures necessary to: (1) prevent cross-contact between products, 

equipment, and utensils that do and do not contain allergens and (2) assure 

accurate label declarations on products that do contain allergens. Any food 

safety system procedures designed to control allergens must be effectively 

implemented on an ongoing basis to ensure adequate control. 

Avoiding cross-contact between products containing a food allergen and those 

that do not is critically important. Cross-contact could result from inadequate 

control or inappropriate use of ingredients of public health concern. Situations 

that might allow for cross-contact to occur include the establishment 

failing to: 

 Check ingredient containers for damage at receiving to prevent allergen 

contamination within the establishment. 

 Implement a program to ensure proper identification and control of 

allergenic ingredients, allergen containing products, and allergen 

containers through receiving, weighing, formulation, and packaging. 

 Ensure effective sanitation measures are in place to address the potential 

for cross-contact when producing multiple products with different 

formulations. 

 Implement adequate sanitation procedures for cleaning of utensils and 

equipment used in formulating and processing both products containing 

an allergen and products without allergens. 

 Train employees on the appropriate use of ingredients and the need to be 

especially careful when working with allergens. 

 Appropriately identify/store products to be reworked that contain an 

allergen. 

 Manufacture a product in accordance with the intended product 

formulation. 

In addition to inadequate controls to prevent cross-contact, accidental application 

of inaccurate labels to properly formulated products could pose a threat to 

consumers sensitive to any ingredients in the formulation. Examples of how 

inaccurate labeling of a product can occur include the establishment failing 

to: 

 Declare ingredients listed in the product formula on the product label by 

common or usual name. 

 Change labels when changing over from one product formulation to 

another. 

 Review the labels on incoming non-meat/non-poultry ingredient mixes at 

receiving for changes. 

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 Discard obsolete labels after a change in product formulation. 

 Review newly printed labels to ensure accuracy. 

 Control labels for products with similar appearance but different 

ingredients to ensure application of the correct label (e.g., storing mixed 

bundles of labels for similar products with different ingredient formulas 

which could lead to a mix up of labels). 

 Maintain adequate production controls over a product that contains an 

allergenic ingredient and is intended for rework, allowing it to be reworked 

into a product not labeled to contain that ingredient. 

 Declare an allergen that was indirectly added to the product. An example 

would be an establishment that is producing product on a food contact 

surface sprayed with a non-stick coating (a release agent intended to 

prevent product from adhering to the food contact surface) containing soy 

lecithin and is not properly declaring the soy lecithin on its finished product 

label. Note that substances used as release agents on surfaces, including 

grills, loaf pans, cutters, or other hard surfaces, are generally considered 

to be processing aids and are not required to be declared in the 

ingredients statement on the meat or poultry product label. However, if a 

particular release agent contains a known allergen, such as soy lecithin, 

official establishments must list the allergenic ingredient in the ingredients 

statement on the product label. Many cooking sprays (e.g., PAM®) used 

as release agents will contain soy lecithin as an emulsifier. Some may 

contain other allergenic ingredients as well. 

NOTE: It is always the responsibility of each official establishment to determine 

and support the safety of all chemical substances used in its process, including 

all non-meat/non-poultry food ingredients and processing aids. However, the 

following information may be helpful when IPP review an establishment’s hazard 

analysis and supporting documentation regarding the use of highly refined edible 

oils. 

1. Highly refined edible oils, such as soybean oil and peanut oil, are the 

result of processing that involves de-gumming, neutralizing, bleaching, 

and deodorizing extracted oils. This refining improves the quality of plantbased oils by removing a variety of undesirable chemicals, imparting a 

uniform color, and eliminating undesired odors. A benefit of refining edible 

oils is that the process renders them virtually free of allergenic proteins 

according to the Institute of Shortening and Edible Oils. Scientific studies 

indicate that refined edible oils are safe for the food-allergic population to 

consume. In contrast, mechanical or “cold press” extraction of oils from 

plant materials may not remove all protein; however, cold-pressed oils are 

rarely used. 

2. Allergen-containing products cooked or par-fried in highly refined edible 

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

Establishments that reuse the same oil to cook or par-fry a variety of 

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products should consider the potential hazard such reuse might pose to 

food-allergic consumers. 

Label Declarations 

The fact that some individuals have allergies or intolerances to certain foods and 

food ingredients emphasizes the importance of accurate, informative product 

labeling. Under the Federal Meat Inspection Act (FMIA) and the Poultry Products 

Inspection Act (PPIA) all ingredients used to formulate meat or poultry products 

generally must be declared in the ingredients statement on the product label. A 

product is misbranded under the FMIA or PPIA when it contains ingredients that 

are permitted but not declared on product labeling. Therefore, the general 

expectation is that, with few exceptions, all ingredients should be declared on the 

labeling of meat and poultry products. FSIS guidance for many years has been 

that ingredients of public health concern should always be declared in the 

ingredients statement. 

FSIS regulations require that any ingredient be declared only by its common or 

usual name in the ingredients statement. In addition to accurately declaring 

product ingredients, though, FSIS supports the use of voluntary statements on 

labels to alert people who have sensitivities or intolerances to the presence of 

specific ingredients. For example, a label statement like, “Contains: milk, wheat 

gluten, soy” would alert consumers to these ingredients of public health concern. 

FSIS further supports identifying the source of a specific ingredient in a 

parenthetical statement. For example, a product label might specify, “Contains 

sodium caseinate (from milk)” to alert milk allergic consumers that the ingredient 

is derived from milk. 

In limited situations, the Labeling and Program Delivery Staff (LPDS) of FSIS 

does permit the use of factual labeling statements about a product’s 

manufacturing environment such as, “Produced in a plant that uses peanuts,”

or “may contain” statements like, “may contain peanuts,” on meat and poultry 

product labeling. However, the use of a factual statement about a product’s 

manufacturing environment or a “may contain” 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 cross-contact of 

products with ingredients of public health concern. The Agency believes the 

indiscriminate use of such elective statements does not promote good 

manufacturing practices under a HACCP system and is not helpful to consumers. 

Consequently, the use of such statements may only be used in cases where 

establishments show that adequate Sanitation SOPs cannot effectively eliminate 

the potential for cross-contact. LPDS evaluates and approves factual labeling 

statements on a case-by-case basis. 

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FACTUAL LABELING STATEMENT EXAMPLE: 

An official establishment uses chopped peanuts in making a dry, Thai-style meat 

sauce mix. During operations, it is necessary for the processing environment to 

remain dry; thus, the production equipment cannot be washed with water or other 

fluids. In this instance, peanut dust may become airborne and unavoidably 

contaminate other meat or poultry products manufactured in the same production 

area. In such situations, a statement about the manufacturing environment, as 

described above, or the use of a “may contain (name of allergenic ingredient)” 

statement has been approved by LPDS. However, this type of statement is not 

acceptable where it is used as a replacement for poor Sanitation SOPs, i.e., the 

potential for cross-contact because an establishment fails to adequately wash 

equipment between the production of different products. 

FSIS will also consider any non-misleading symbols, statements, or logos to 

inform consumers of the presence of ingredients of public health concern in meat 

or poultry products. An establishment may submit such a request to the Agency 

as a policy inquiry but not as label-approval submission. 

All ingredients listed on labels of incoming food and food ingredients (e.g., multiingredient products such as soy sauce and bread) must be listed on labels of the 

meat and poultry products in which they are used as ingredients unless FSIS has 

determined that a particular use of an ingredient is consistent with the FDA’s

definition of a processing aid or incidental additive. All of the ingredients listed in 

a “may contain” or “produced in a facility” statement must be listed on the final

label except in situations where the establishment contacts the supplier of the 

component and addresses the statement in its hazard analysis. Specifically, all 

the ingredients in a “may contain” or “produced in a facility” statement may not 

need to be listed on the final label if the official establishment: (1) contacts the 

supplier and confirms, preferably in writing, that the statement is a cautionary 

statement, and no such ingredient is in the product; and (2) includes a written 

statement in its hazard analysis documentation to support why the “may contain” 

or “produced in a facility” statement is not carried forward to the finished meat or 

poultry product label. 

NOTE: Some of the chemicals mentioned in this handout may be classified as 

“generally recognized as safe” (GRAS) compounds. A GRAS food additive is 

generally recognized, among qualified experts, as having been shown to be safe 

under the conditions of its intended use. You may wonder why any GRAS 

ingredients would be of public health concern. All ingredients used in meat and 

poultry products are required to be safe. The designation of a particular food 

ingredient as GRAS relates to a determination that the ingredient is safe for 

human consumption. However, it is not the safety of the substance itself that is 

the problem. This module focuses on concern over the addition of ingredients 

reported to cause adverse health effects in some individuals and an 

establishment’s failure to properly declare those ingredients on the product label. 

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7/3/2017 

It is important to remember that establishments must consider all potential 

chemical food safety hazards in their hazard analyses, including ingredients that 

are GRAS substances. 

Inspection Program Personnel Responsibilities 

Obviously, it is important that establishments have preventive measures and 

controls to address all potential chemical hazards, including food allergens and 

other ingredients of public health concern. If a meat or poultry establishment 

ships product containing an undeclared allergen into commerce, then its food 

safety system has failed. The establishment may have failed to address the 

allergen as a potential chemical food safety hazard in its hazard analysis, failed 

to support the decisions made in the hazard analysis, or failed to effectively 

implement controls supporting the decisions made in the hazard analysis. 

As mentioned earlier, numerous recalls have occurred due to undeclared 

allergens. FSIS analyses of recalls connected to undeclared allergens have 

revealed that many occurred 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 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. 

It is vitally important for IPP to always be vigilant with regard to establishments’

preventive measures and controls for allergens and other ingredients of public 

health concern. Multiple inspection tasks may be relevant to verifying that an 

establishment’s food safety system meets regulatory requirements with regard to 

allergens and other ingredients of public health concern, including the HAV task, 

the HACCP Verification tasks, the Review of Establishment Data task, Preoperational and Operational SSOP tasks, the General Labeling Task, and the Big 

8 Formulation Verification task. They will issue a Noncompliance Record (NR) 

under the appropriate inspection task when the establishment: 

• Fails to address a potential chemical food safety hazard in its process. 

• Fails to implement its Sanitation SOPs or other prerequisite programs 

adequately to support a decision that a chemical food safety hazard is not 

likely to occur. 

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• Does not have adequate documentation on file to support decisions made 

in its hazard analysis for hazards that are not reasonably likely to occur. 

• Fails to appropriately declare any allergen or other ingredient of public 

health concern on the product label. 

The Big 8 Formulation Verification Task 

Now, we will focus on the Big 8 Formulation Verification task, which provides IPP 

with a method for verifying that establishments are accurately controlling and 

labeling the eight most common food allergens. The Big 8 Formulation 

Verification task methodology is described in FSIS Directive 7230.1. Performing 

the task will involve reviewing records, observing production processes, and 

responding to specific task-related questions in PHIS. 

IPP assigned to establishments that produce products in any of the HACCP 

processing categories other than slaughter must determine whether the 

establishment produces any products that may contain any of the Big 8 food 

allergens. If IPP determine the establishment does produce any products that 

may contain any of the Big 8 food allergens, they should review the preventive 

and control measures developed by the establishment and verify that such 

measures are being effectively implemented, including that product labels are 

consistent with product formulation records. Note that, depending on its 

processes and decisions made in its hazard analysis, an establishment’s 

preventive and control measures to address allergens may be within its HACCP 

plan, its Sanitation SOPs, and/or a prerequisite program. 

NOTE: If the Big 8 Formulation Verification task does not apply to the operations 

in a given establishment according to the criteria in FSIS Directive 7230.1, IPP 

are to find the task on the Establishment Profile/Inspection Tasks page for that 

establishment and disable the task. Refer to FSIS Directive 13,000.1 for 

instructions on disabling an inspection task when it does not apply to an 

establishment. 

For establishments in which the task is relevant, a routine Big 8 Formulation 

Verification task will appear monthly on the Establishment Task List as a Priority 

3 task in PHIS. In establishments with multiple shifts, IPP will perform the routine 

verification task on each shift. Big 8 Formulation Verification tasks may be 

performed more frequently as directed tasks if there are any indications of 

increased risk of undeclared allergens in the establishment. For example, the 

production of a new product, changes in product formulation, sanitation NRs 

related to allergen control, or other labeling NRs, may be indication of increased 

risk of undeclared allergens. IPP are to discuss the circumstances and their 

concerns of increased risk of undeclared allergens with their supervisor and 

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frontline supervisor before scheduling additional Big 8 Formulation Verification 

tasks as directed tasks. 

When performing the routine Big 8 Formulation Verification task IPP must first 

schedule the task in advance and determine which products will be produced on 

that date. Next they must select a product for the task. This requires coordinating 

with IPP on the other shift, if applicable, to avoid selecting the same product for a 

task. IPP must also avoid selecting the same product for consecutive tasks 

without first attempting to select products that have not been selected previously, 

unless there has been a change in supplier, change in ingredients, change in 

formulation, or the establishment produces a very limited number of products. 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. IPP are to apply the 

priority list to all products in an eligible establishment whether or not the 

establishment produces products containing a “Big 8” allergen.

Inspection Methods 34-12 
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. 

Ingredients of Public Health Concern 

7/3/2017 

NOTE: Examples of multi-ingredient components include sauces, condiments such as ketchup 

or mustard, seasoning packets, flavorings, spice mixes, soup bases, or other combinations of 

two or more ingredients that are mixed together (in this case, outside of the establishment). 

After selecting a product, IPP are to obtain the specific product formulation (or 

recipe) for that product from the establishment. The establishment may consider 

its product formulation proprietary information; however, meat and poultry 

establishments are required to provide IPP accurate information on all 

procedures involved in product preparation, including product composition, for 

verification in accordance with 9 CFR 318.6 and 9 CFR 381.180. 

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

recordkeeping and review and observation inspection components for the 

production of the selected product. Performing the task involves: 

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1. 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. 

2. 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. 

3. Verifying the appropriate label is the label being applied to the product. 

4. Verifying the applied label is consistent with the establishment’s label 

approval on file. 

NOTE: IPP can use the list of common ingredients and foods in Attachment 1 of 

FSIS Directive 7230.1 for help in identifying “Big 8” allergens.

Additional considerations regarding multi-ingredient seasonings or spices, 

processing aids or incidental additives, release agents, and “may contain” or

“produced in a facility” statements on incoming food and food ingredients are 

outlined in FSIS Directive 7230.1. 

As part of documenting the task in PHIS, IPP will respond to specific questions 

related to this task located on the “additional info” tab of the task documentation 

page. Attachment 2 of FSIS Directive 7230.1 provides more information 

regarding these questions. 

Documenting Noncompliance with the Big 8 Formulation 

Verification Task 

Whenever IPP determine that a meat or poultry product contains one of the Big 8 

allergens, but the establishment failed to declare the allergen in the ingredients 

statement on the product label, they are to document noncompliance on a 

Noncompliance Record in PHIS under the Big 8 Formulation Verification task. 

IPP will cite the relevant food safety regulation(s) and the appropriate labeling 

regulation (9 CFR 317.2(f) for products bearing the meat inspection legend or 9 

CFR 381.118 for products bearing the poultry inspection legend). In addition, IPP 

must always notify their supervisor when they identify such noncompliance so 

that a recall request determination can be made. 

NONCOMPLIANCE EXAMPLE 1 

While performing a Big 8 Formulation Verification task, an inspector determined 

that a meat product contained an allergen the establishment had failed to declare 

in the ingredients statement on the product label. The inspector immediately 

Inspection Methods 34-14 
Ingredients of Public Health Concern 

7/3/2017 

notified establishment management. Further investigation revealed this occurred 

because the establishment did not recognize that its supplier of a marinade 

solution had recently altered the formulation of the marinade solution to include a 

soy-based ingredient. The establishment was able to provide records to support 

that all affected product was still under its control (i.e., no affected product had 

entered commerce). The inspector then contacted her FrontLine Supervisor to 

inform him of her findings. The meat establishment had not considered the 

allergenic ingredient as a potential chemical hazard in its hazard analysis; 

therefore, the inspector cited 9 CFR 417.2(a)(1) on the Noncompliance Record. 

The inspector also cited 9 CFR 317.2(f) because the establishment failed to list 

all ingredients in the ingredients statement as required for a product bearing the 

meat inspection legend. There was no previous noncompliance due to the same 

cause. The inspector completed the task after she verified the establishment had 

implemented and documented corrective actions in accordance with 9 CFR 

417.3(b) and 9 CFR 417.3(c). 

NONCOMPLIANCE EXAMPLE 2 

An establishment produced a variety of dry seasoned and marinated, raw poultry 

products. Some product formulations contained one or more allergens and some 

did not. In its hazard analysis, the establishment concluded that allergens were 

not reasonably likely to occur on the basis of its allergen control prerequisite 

program. The allergen control program included operational and pre-operational 

Sanitation SOPs designed to prevent cross-contact with allergens as well as a 

procedure for verifying label accuracy for each product at the packaging and 

labeling step. While performing a Big 8 Formulation Verification task, an 

inspector determined that a product containing an allergen was being labeled 

with a label for a similar product whose formulation did not include the allergenic 

ingredient; therefore, the ingredients statement did not include the name of the 

allergenic ingredient. The inspector took a regulatory control action by rejecting 

the packaging line to stop production of the adulterated and misbranded product. 

He also identified and retained affected product in the establishment’s finished 

products cooler to prevent the product from being shipped. He immediately 

notified establishment management of the basis for the regulatory control 

actions. The establishment provided production records supporting that no 

affected product had been shipped. The inspector contacted his supervisor and 

informed her of his findings. Next, the inspector documented noncompliance with 

9 CFR 417.2(a)(1) and 417.5(a)(1) because the establishment’s prerequisite 

program failed to effectively prevent the chemical hazard from being reasonably 

likely to occur. In addition, he cited noncompliance with 9 CFR 381.118 because 

the establishment failed to list all ingredients in the ingredients statement as 

required for a product bearing the poultry inspection legend. The inspector 

followed up by verifying the establishment implemented and documented 

appropriate corrective actions in accordance with 9 CFR 417.3(b) and 417.3(c). 

Inspection Methods 34-15 
Ingredients of Public Health Concern 

7/3/2017 

NONCOMPLIANCE EXAMPLE 3 

A further processing establishment produces a variety of partially cooked and 

fully cooked meat and poultry products. Many products produced by the 

establishment contain at least one allergenic ingredient. The establishment has 

operational and pre-operational Sanitation SOPs designed to prevent cross 

contact. At the product rework step in each of its hazard analyses, they support 

that allergens are not reasonably likely to occur on the basis of a prerequisite 

program designed to ensure that any given batch of product identified for rework 

will be appropriately identified, stored in a manner to ensure no contact with 

different products held for rework, and only reworked into product with the same 

ingredients. In addition, it has identified that allergens are reasonably likely to 

occur at the finished product labeling in each of its hazard analyses. In each 

HACCP plan, there is a CCP at the finished product labeling step. The critical 

limit at this CCP is that all finished product packages must bear labels that 

accurately declare the allergenic ingredient(s) included in the product 

formulation. The monitoring procedure described for this CCP specifies that a QA 

technician will visually inspect labels applied to finished products to ensure the 

ingredients statement is consistent with each product’s formulation. The

frequency of monitoring specifies that visual inspection of one label will be 

performed at the beginning of each production lot and of one label hourly until 

completion of each production lot. As part of conducting a Big 8 Formulation 

Verification task, an inspector identified a beef product whose formulation had 

recently been changed. Previously, the product formulation included a soy-based 

ingredient, but it had been changed to also include a peanut-based ingredient. 

After reviewing formulation records on this particular product, the inspector 

proceeded to the monitoring location for the CCP to review the finished product 

label. He noted that the label being applied at that time only included the soybased ingredient. He immediately notified a production supervisor of the critical 

limit deviation. Further investigation revealed that, sometime after the 

establishment’s last hourly monitoring check, another roll of preprinted labels had 

been retrieved from a storeroom. Unfortunately, all labels based on the old 

formulation had not yet been destroyed, and a production employee had 

inadvertently retrieved a roll of the old labels. The establishment was able to 

support that product affected by the critical limit deviation was restricted to only 

that produced since the last hourly monitoring check. The inspector notified his 

supervisor of the issue, documented noncompliance with 9 CFR 417.2(c)(4) and 

9 CFR 317.2(f), and verified the establishment implemented and documented 

appropriate corrective actions in accordance with 9 CFR 417.3(a) and 417.3(c). 

NOTE: IPP are to always consider what their findings show about the overall 

effectiveness of the establishment’s food safety system and take these findings 

into account during the performance of the next Hazard Analysis Verification 

(HAV) task. If IPP identify concerns when performing the Big 8 Formulation 

Verification task and believe a directed HAV task should be performed, they are 

to discuss those concerns with their supervisor. 

Inspection Methods 34-16 
Ingredients of Public Health Concern 

7/3/2017 

Documenting Noncompliance for Other Undeclared Ingredients 

If IPP determine that a product contains an ingredient not declared in the 

ingredients statement, but that ingredient is not one of the Big 8 allergens, IPP 

are to schedule a directed General Labeling task and document General 

Labeling noncompliance with 9 CFR 317.2(f) for products bearing the meat 

inspection legend or 381.118 for products bearing the poultry inspection legend. 

Note that this instruction would apply to any ingredient that is not one of the Big 8 

allergens, including other ingredients of public health concern discussed in this 

module. 

Other Actions 

IPP may need to take regulatory control of product at the official establishment if 

necessary to prevent the product from entering commerce. IPP must always 

contact their FLS for guidance if at any time they have reason to believe any 

product bearing labels that fail to declare one of the “Big 8” food allergens or any 

other ingredient of public health concern has entered commerce. An immediate 

withholding action on the process may be necessary, and a product recall may 

be requested by the Recall Management and Technical Analysis Staff (refer to 

FSIS Directive 8080.1 for more information on recalls). 

Additional Resources 

 FSIS Compliance Guidelines - Allergens and Ingredients of Public 

Health Concern: Identification, Prevention and Control, and 

Declaration through Labeling November 2015 

http://www.fsis.usda.gov/wps/wcm/connect/f9cbb0e9-6b4d-4132-ae27-

53e0b52e840e/Allergens-Ingredients.pdf?MOD=AJPERES 

 Additives in Meat and Poultry Products 

www.fsis.usda.gov/wps/portal/fsis/topics/food-safety-education/getanswers/food-safety-fact-sheets/food-labeling/additives-in-meat-andpoultry-products/additives-in-meat-and-poultry-products 

 Allergies and Food Safety 

www.fsis.usda.gov/wps/wcm/connect/1e98f24c-d616-443f-8490-

f7372476d558/Allergies_and_Food_Safety.pdf?MOD=AJPERES 

 A Guide to Federal Food Labeling Requirements for Meat and Poultry 

www.fsis.usda.gov/wps/wcm/connect/f4af7c74-2b9f-4484-bb16-

fd8f9820012d/Labeling_Requirements_Guide.pdf?MOD=AJPERES 

 Allergens - Voluntary Labeling Statements 

Inspection Methods 34-17 
Ingredients of Public Health Concern 

7/3/2017 

www.fsis.usda.gov/OPPDE/larc/Ingredients/Allergens.htm 

 Tips for Avoiding Your Allergen 

http://www.foodallergy.org/document.doc?id=133 

 Food Allergy: An Overview 

www.niaid.nih.gov/topics/foodAllergy/Documents/foodallergy.pdf 

 Egg Allergy Avoidance List 

www.kidswithfoodallergies.org/docs/Egg_Allergy_Avoidance_List.pdf 

 Milk Allergy Avoidance List 

www.kidswithfoodallergies.org/docs/Milk_Allergy_Avoidance_List.pdf 

 Peanut Allergy Avoidance List 

www.kidswithfoodallergies.org/docs/Peanut_Allergy_Avoidance_List.pdf 

 Soy Allergy Avoidance List 

www.kidswithfoodallergies.org/docs/Soy_Allergy_Avoidance_List.pdf 

 Wheat Allergy Avoidance List 

www.kidswithfoodallergies.org/docs/Wheat_Allergy_Avoidance_List.pdf 

 Tree Nut Allergy Avoidance List 

www.kidswithfoodallergies.org/resourcespre.php?id=60&title=Tree_nut_all 

ergy_avoidance_list 

 Components of an Effective Allergen Control Plan: A Framework for 

Food Processors 

farrp.unl.edu/allergencontrolfi 

 Cleaning and Other Control and Validation Strategies To Prevent 

Allergen Cross-Contact in Food-Processing Operations 

www.charm.com/resource/file/218/ 

Inspection Methods 34-18