FSIS Guideline for Industry Response to Customer Complaints

This guideline is designed to

help meat and poultry

establishments develop a

written program to respond to

customer complaints. This

guidance covers:

• How to respond to

customer complaints of

adulterated or misbranded

meat and poultry products

• The recall notification

requirements in

9 CFR

418.2

FSIS Guideline for Industry Response to

Customer Complaints

2020

Preface:

FSIS developed this guideline to communicate what FSIS has identified as best

practices for meat and poultry establishments to respond to customer complaints. The

guideline was developed with appropriate review and public participation and has been

revised in response to public comments. Some portions of the document have been

rearranged to highlight FSIS recommendations for developing a customer complaint

program and to further clarify existing FSIS regulatory requirements. This guideline

follows the procedures in the Office of Management and Budget’s (OMB) “Final Bulletin

for Agency Good Guidance Practices” (GGP). You can find more information on

guidance documents on the Food Safety and Inspection Service (FSIS) Web page

. The

meat and poultry trade associations, along with their members, have developed a

related document,

Industry Best Practices for Customer Complaints of Foreign Material

in Meat and Poultry Products. Establishment personnel may want to use guidance from

both documents when developing a response to customer complaints.

What is the purpose of this guideline?

The purpose of this guideline is to inform industry of the procedures FSIS has identified

as best practices for responding to customer complaints of adulterated and misbranded

meat and poultry products. FSIS developed this document in response to an increase

in the number of recalls of meat and poultry products adulterated with foreign materials.

In many cases, the recalling establishment had received multiple customer complaints

prior to these recalls. FSIS specifically developed this document to address foreign

material customer complaints, but establishments can apply the information to other

customer complaints of adulterated or misbranded products in commerce. This

guideline represents FSIS’s current thinking on this topic and should be considered

usable as of the issuance date.

Who is this guideline designed for?

FSIS is issuing this document to assist all FSIS-regulated meat and poultry

establishments in developing and implementing procedures for responding to customer

complaints, and in preventing similar adulteration or misbranding occurrences.

Does the guidance reflect requirements?

This document is not regulatory. An establishment may choose to adopt different

procedures than those outlined in this guideline. This guideline recommends each

establishment develop a customer complaint program. However, an establishment can

operate without a customer complaint program because there is no regulatory

requirement to develop or implement a program to address customer complaints. If an

establishment voluntarily decides to develop a customer complaint program, there is no

requirement that a program be incorporated into its Hazard Analysis and Critical Control

Point (HACCP) system. Customer complaints occur after the product has left the

establishment, so a program to respond to complaints is not preventing hazards or

adulteration. However, when a customer complaint results in findings of adulterated

products, the establishment must meet applicable requirements as described below.

What if I still have questions after I read this guideline?

FSIS recommends that users search the publicly posted Questions & Answers (Q&As)

in the askFSIS database or submit questions through askFSIS

. Documenting the

questions helps FSIS improve and refine present and future versions of the guideline

and associated issuances.

When submitting a question, use the Submit a Question tab, and enter the following

information in the fields provided:

Subject Field: Enter FSIS Guideline for Industry Response to Customer

Complaints.

Question Field: Enter question with as much detail as possible.

Product Field: Select General Inspection Policy from the drop-down menu.

Category Field: Select Regulations/Agency Issuances from the drop-down menu.

Policy Arena: Select Domestic (U.S.) Only from the drop-down menu.

When all fields are complete, press Continue.

FSIS Guideline for Industry Response to Customer Complaints

Table of Contents

Preface: ................................................................................................................................ 2

Background: ........................................................................................................................ 5

Developing a Customer Complaint Program: ................................................................ 6

 Overview of the Program ....................................................................................... 6

 Customer Complaint Reporting ............................................................................ 6

 Substantiation of the Customer Complaint......................................................... 7

 What are Adulterated or Misbranded Products?.............................................. 10

 When are Products in Commer ce?..................................................................... 10

 Establishment Response to a Customer Complaint........................................ 12

 Documentation of the Customer Complaint ..................................................... 13

Regulatory Requirements ............................................................................................... 13

FSIS Regulatory Requirements: Notification .................................................... 15

FSIS Regulatory Requirements: HACCP System ............................................. 18

Corrective Actions ....................................................................................... 18

Suggested Tips ................................................................................................................. 22

Example Flow Diagram of a Customer Complaint ...................................................... 23

References:........................................................................................................................ 24

Background:

FSIS is the public health regulatory agency responsible for ensuring that the nation’s

commercial supply of meat, poultry, and egg products is safe, wholesome, and correctly

labeled and packaged. In 2008, Congress amended the Federal Meat Inspection Act

(FMIA) and the Poultry Products Inspection Act (PPIA) to require each establishment to

promptly notify the Secretary if they believe, or have reason to believe, that adulterated

or misbranded meat or poultry products have entered into commerce (21 U.S.C. 612

and 459(b)). The Secretary delegated this responsibility to FSIS. In 2012, FSIS issued

final regulations reflecting these requirements (9 CFR part 418

). Since the

implementation of the regulation in May 2012, FSIS has observed an increase in the

number of recalls associated with foreign materials and has developed this guideline to

assist establishments in responding to complaints and meeting related regulatory

requirements, when applicable.

FSIS recommends, but does not require, that each establishment develop a program to

receive and process customer complaints concerning possibly adulterated or

misbranded products in commerce. When an establishment chooses to implement a

customer complaint program, FSIS recommends it develop and maintain a program that

addresses the receipt and investigation of complaints, the implementation of corrective

actions, and the notification of FSIS that adulterated or misbranded products have

entered commerce. A discussion of regulatory requirements is included later in the

guideline; however, a customer complaint program is not a regulatory requirement. The

regulatory requirements are included for informational purposes and may result in a

more robust customer complaint program.

KEY QUESTION

Question: Is a meat or poultry establishment required to notify FSIS every time they have reason to

believe that an adulterated or misbranded product has entered commerce?

Answer: Yes, under 9 CFR 418.2

, each establishment is required to notify the District Office within 24

hours of learning or determining that they have received or shipped into commerce adulterated or

misbranded meat or poultry products. When a receiving establishment notifies FSIS inspection

personnel, the establishment is in compliance with this regulation. The producing establishment is not

expected to also notify FSIS if the receiving establishment has already notified the Agency of the issue.

Developing a Customer Complaint Program:

 Overview of the Program

A well-developed and implemented customer complaint program provides many

benefits including assisting the establishment in complying with other regulatory

requirements and reducing the long-term financial costs of recalls.

A consumer complaint program should include the following components (discussed in

more detail in this guideline):

 Customer Complaint Reporting

 Substantiation of a Customer Complaint

 Response to a Customer Complaint

o Establishment Response Plan and Investigation

 Documentation of a Customer Complaint

 Related Regulatory Requirements

o FSIS Notification (when required by 9 CFR 418.2

)

o Corrective Actions (when required by 9 CFR 416.15 or 417.3)

 Customer Complaint Reporting

Customer complaints may originate from: another establishment, a household

consumer, the USDA Consumer Complaint Monitoring System (CCMS), or another

regulatory agency

. Regardless of the source, each customer complaint should be

evaluated as a possible report of adulterated or misbranded products in commerce.

Each establishment should develop appropriate mechanisms to receive and process

customer complaints.

The establishment should provide household consumers with a method for reporting a

complaint, for example:

• Postal address;

• Toll-free number;

• Website address; or

• E-mail address.

The establishment should provide non-household consumers (e.g., other

establishments, hotels, restaurants, or institutions) with a method for reporting a

complaint, for example:

• Company representative contact information; or

• Instructions within the contract or bill of lading.

Although other regulatory agencies are not “customers” they are included as possible sources of complaints and

may be included in a robust program.

As technology and social networking change, other methods for reporting complaints

may be developed and incorporated into the customer complaint program. The

establishment may provide contact information and methods to report a complaint on

product labels, shipping documents, or can post this information on the company’s

webpage.

An establishment that re-labels or co-packs products should be aware that a customer

might direct complaints to the company name on the label. As a result, FSIS

recommends that co-packers work with the company named on the label to develop a

method for reporting and tracking complaints. When the establishment uses a third-

party contractor to collect and process customer complaints or when complaints are

directed to a corporate address, the establishment should consider how these

complaints will be relayed to the producing establishment. The establishment customer

complaint process may also include quality complaints; however, a system should be in

place to prioritize or triage those complaints that indicate adulterated or misbranded

meat or poultry products have been produced at the establishment.

 Substantiation of the Customer Complaint

An establishment should develop criteria and a mechanism for reviewing any customer

complaint. The establishment should verify where the products were produced.

Products are often similar and may be produced at multiple locations, so the

establishment should verify that the products were produced at its location and, if not,

notify the customer or other establishment when appropriate. The establishment should

also develop criteria to determine whether tampering of the products occurred after

shipment from the producing establishment. The establishment should determine what

evidence, if any, the customer has of the adulteration and misbranding. Information that

can be used to substantiate a claim includes:

• Evidence of the physical contaminant,

• Photographs,

• Video, or

• A sample of the product label, product, and any other applicable material.

The product label provides information to verify the source of the product, including the

lot number, establishment number, and product name. An image or a sample of the

product provides information to verify that the product matches the label and can show

the condition of the product. An image or a sample of any physical adulteration, such

as foreign material, provides information that can be used to start the investigation into

the cause of the adulteration. The purchase location may also be helpful to identify

distribution channels that may have contributed to the adulteration or misbranding.

NOTE: If the product does not match the label, this could be the basis of a misbranding

claim and should be evaluated as evidence of misbranding.

Each establishment should begin to substantiate complaints as soon as possible when

there is the possibility that adulterated products have been purchased by household

consumers. Products available at the level of the household consumer add a degree of

urgency to removing adulterated products before they are consumed, especially when

the adulteration is a food safety hazard. At this point in the process, initial

substantiation, it may not be possible to determine if the adulteration is a food safety

hazard, so it is important to move quickly to gather information. When the

establishment determines that hands-on examination of the products, labels, or any

other material is important in determining whether adulterated products have been

produced, it should not delay the shipment of the identified foreign objects, samples of

the products, or labels for examination by the producing establishment. The FSIS

recommended practice is to perform an initial substantiation and investigation using

immediately available photographic or video evidence and take appropriate action

based on that evidence and then follow up with additional actions, as warranted, if the

physical material, products, or labels are made available for a hands-on examination.

As soon as the establishment has reason to believe

adulterated or misbranded products have entered

commerce, then FSIS must be notified per

9 CFR

418.2. It may not be necessary to perform a

physical examination of the products, material, or

labels to have reason to believe adulterated

products have entered commerce. For example,

some customers may be able to provide a credible

description of the product with adequate detail to

have a reasonable belief that adulterated products

entered commerce. Also, multiple reports of similar

foreign materials, especially when the initial report

has been validated, may be enough to take action

without any physical evidence from the additional

reports of adulteration. If there is epidemiological

evidence that a specific product is implicated in a

series of injuries or illness, that may be enough

evidence to substantiate that adulterated products

have entered commerce, without observing foreign

material. Reports of adulterated or misbranded

products from customers other than a household

consumer are also critical and should be prioritized

over quality complaints. Quick action on these complaints can prevent distribution to

households and consumer injury.

The establishment should identify the specific establishment employee(s) (name or title)

who will receive notification of complaints and will be responsible for their initial

substantiation. Since complaints may occur on weekends, FSIS recommends that

applicable contact information be included in the program. Early action is critical to

identifying products in distribution channels, correcting the issue to prevent further

adulteration or misbranding, and removing adulterated or misbranded products from

households before they are consumed.

When an establishment determines that a customer complaint claim is not valid or not

applicable to FSIS-regulated products, FSIS recommends that the establishment

maintain documentation to support how that decision was made. Such documentation

Recommendation

Each establishment should

develop the criteria and

mechanisms for determining if

the products were produced at

that establishment, if a customer

complaint is genuine, authentic,

and that no tampering of the

products occurred after shipment

from the producing

establishment.

could be used to support why the establishment did not take any actions related to the

products, especially if new evidence, which does support the initial claim, is identified in

the future.

The establishment must consider if any FSIS-regulated products are implicated by a

complaint. The initial complaint may be related to a product under Food and Drug

Administration (FDA) jurisdiction; however, when there are common ingredients or

common production areas, the possible contamination of FSIS-regulated products must

be considered. It is not an FSIS regulatory requirement to maintain documentation

related to products that are not regulated by FSIS or whose production does not impact

FSIS-inspected products. However, an establishment may want to maintain

documentation regarding complaints about the FDA products that it produces and must

comply with any FDA regulations regarding reporting and recalling adulterated products.

NOTE: A valid complaint for products under FDA jurisdiction must be addressed as

required by FDA regulations.

Some examples of why a complaint may be

found to be without merit related to FSIS

principles include:

• Implicated products not produced,

distributed by, or owned at any point by

an establishment or corporation.

• A valid complaint determined not to

involve an FSIS food safety hazard,

adulterated products, or misbranding,

e.g., a complaint about quality.

• Products that are not under FSIS

jurisdiction and there are no implications

for FSIS-inspected products.

When the establishment has identified a valid

complaint and believes, or has reason to

believe, that adulterated or misbranded

products shipped or received by the

establishment have entered commerce, the

establishment must notify the FSIS District

Office within 24 hours (9 CFR 418.2

Depending on the procedures used to validate

the complaint, further investigation may or may

not be required to make this determination.

When an establishment receives a customer

complaint and it is substantiated, the next two

questions to ask are: 1) Is the product

adulterated or misbranded? and 2) Has it

entered commerce?

What are adulterated or

misbranded products?

Adulterated: Meat or poultry

products that are injurious to health

or are for any other reason unsafe,

unsound, unhealthful, unwholesome,

or otherwise unfit for human food.

Misbranded: Meat or poultry

products that bear a false or

misleading label or if any required

feature is not prominent.

 What are adulterated or misbranded products?

Meat or poultry products are adulterated, among other reasons, if they bear or contain

any poisonous or deleterious substance that may render them injurious to health; are

unhealthful, unwholesome, or otherwise unfit for human consumption; or were prepared,

packaged, or held under insanitary conditions whereby they may have been rendered

injurious to health (see 21 U.S.C. 453(g) and 21 U.S.C. 601(m)).

Meat or poultry products are misbranded if the label is false or misleading, or if it does

not contain the required labeling features (see 21 U.S.C. 453(h) and 21 U.S.C. 601(n)).

Meat and poultry products that are

contaminated with foreign materials are

adulterated under the FMIA and PPIA

regardless of the physical characteristics of the

foreign material (e.g., shape, size, hardness,

etc.) because foreign materials are unfit for

human consumption, may contain poisonous

or deleterious substances, and may indicate

conditions of filth. Material that is inherent to

the species (e.g., bone, hide, feathers) can

result in adulterated or misbranded products

when the contamination’s extent, size, or

shape would render the products

unwholesome or injurious to health. The

establishment should evaluate each complaint

and finding in the context of the specific

product, intended use, HACCP system, and

details of each incident to determine when

meat or poultry products are adulterated.

 When are products in commerce?

An official establishment is required to report to

FSIS when they believe, or have reason to

believe, adulterated or misbranded products

have entered commerce. In the context of this

document and 9 CFR 418.2

, FSIS considers

products to have entered commerce when the

products have left the direct control of the

producing establishment and are in

distribution. This includes products at retail

and products moving between official

establishments or other consignees and not

yet available to institutional or household

consumers at the retail level.

FSIS considers the following to be indications

What is “in commerce”?

When products are not under the

direct control of the producing

establishment and are in distribution,

they have entered commerce, this can

include movement between FSIS-

inspected establishments.

• FSIS considers products to be in

commerce when preshipment

review is signed (unless there

are other written methods to

demonstrate direct control)

and the products are in

distribution.

• Individual determinations are

made on a case-by-case basis

using information including the

establishment procedures to

demonstrate direct control and

the physical location of the

products.

that the producing establishment maintains direct control of products, provided the

controls are sufficiently documented and HACCP system decisions are consistent with

the expressed controls:

• Products are moved between two establishments owned by the same

corporation, under a tamper-resistant seal applied by the producing

establishment.

• Products are at the establishment or located on premises owned or operated by

the producing establishment.

There may be other methods for an establishment to demonstrate it has maintained

direct control of the products. New technologies and other innovation are continually

implemented to improve product movement and this document is not intended to

capture all possibilities. When considering new technologies, business models, and

distribution, an establishment may want to consider these questions to determine if they

are maintaining direct control:

• Who owns the products now?

• Can we prevent an employee (possibly of a different company) from physically

moving/using the products?

• What do we have in writing to demonstrate control?

• If we needed to get the products back to our establishment, can we do so

without involving other companies?

• Do we have direct control of all comingled (possibly affected) products?

• Has preshipment review been signed?

This list is not all inclusive and the answers can vary, but these are the types of

questions an establishment can ask when developing a distribution system or

evaluating a current distribution system, to determine where “direct control” stops and

the products have entered commerce.

One method an establishment may use to demonstrate direct control and determine

when products have entered commerce is by using preshipment review. As required in

9 CFR 417.5(c)

, prior to shipping products into commerce, the establishment must

review the production records of the product, making sure that all processing

requirements were met and, if necessary, all corrective actions were taken. The

establishment should not sign preshipment review until it has reviewed all lot-specific

documentation. Lot-specific documentation includes all records associated with that

specific production including, but not limited to, critical control point (CCP) monitoring,

HACCP verification, corrective actions, prerequisite programs, testing, and any other

applicable programs associated with the production of that lot. Preshipment review

indicates that the product has been determined to be free from food safety hazards as

well as other causes of adulteration and is ready for commerce. The review of the

appropriate documents and compliance with

9 CFR 417.5(c) occurs before the product

leaves the control of the producing establishment and enters commerce. This review

may occur when products are at a location other than the producing establishment, as

long as the producing establishment maintains control of the products.

 Establishment Response to a Customer Complaint

When an establishment receives a customer complaint and determines that adulterated

or misbranded products have entered commerce, the establishment should perform an

investigation to determine the appropriate corrective actions. While a written plan for

addressing customer complaints is not a regulatory requirement, it may be helpful to

facilitate training and to document corrective actions.

The establishment should quickly identify all affected products (e.g., lot, date, line) and

identify where they were distributed. This is an important step in stopping further

distribution and in implementing the establishment’s recall plan. The FSIS

recommended best practice is to draft and maintain a written response plan.

The response plan should include:

- Investigation of the production that incorporates a review of relevant records

generated during the production of the affected products;

- Performing a visual inspection of any questionable products or labels available at

the establishment;

- Observing ongoing production of like products; and

- Talking to employees who may have information pertinent to the investigation.

Affected products that have not been shipped should be held and inspected prior to

shipping so the establishment can determine if there are additional adulterated or

misbranded products. The establishment should use additional information to evaluate

the design and implementation of the HACCP

system, including laboratory sampling results,

intended use of the products, supporting

documentation, and expert analyses. The

establishment is required to maintain a written

recall plan (9 CFR 418.3

). Because some

customer complaints may result in a recall, an

establishment may choose to incorporate a

customer complaint response into the recall plan.

If the establishment determines that adulterated

(and in some cases misbranded) products have

been produced and shipped, the establishment

must meet any applicable regulatory requirements,

as discussed further below, under “Corrective

Action Requirements”.

 Documentation of the Customer

Complaint

The FSIS recommended best practice is for an

establishment to document all customer

complaints (whether substantiated or not), to

21 U.S.C.

610 and 458

Prohibited acts

No person, firm, or corporation

shall sell, transport, offer for sale

or transportation, or receive for

transportation, in commerce, any

such articles which are capable of

use as human food and are

adulterated or misbranded at the

time of such sale, transportation,

offer for sale or transportation or

receipt for transportation.

include the investigative steps that were performed, and to describe how the claim was

or was not substantiated. For substantiated claims of adulterated or misbranded

products in commerce, the records should include how FSIS was notified, what

corrective actions were performed, if a HACCP reassessment was performed, and the

result of the reassessment. If the establishment did not reassess its HACCP plan, FSIS

recommends that the establishment document how determinations were made and

what evidence was used, even when a claim was not substantiated. If an FSIS

investigation occurs at a future date and the establishment has documentation to

support that past complaints were not substantiated, the documentation will help resolve

the investigation and address questions about the complaint. The establishment should

make records related to customer complaints available to FSIS for review upon request

as required by 9 CFR part 320, 416.16, 417.5, and 418.4

Records of the investigations should include the following information (where

applicable):

• Dates of the complaint, any notification, corrective actions, recalls, etc.;

• How the complaint was or was not substantiated;

• Pictures;

• Summary of the complaint including the complainant information;

• Establishment number/manufacturing location on the product label;

• Injury or illness reported;

• Product details and trace back information (product code, lot numbers, date

codes);

• Nature of foreign material (physical characteristics), as applicable;

• Nature of misbranding, label information, label approval;

• Notification of FSIS (who was notified, when, how);

• Potential causes or contributing factors;

• Other implicated products (same line, date, lot, ingredients, establishment);

• Corrective actions, when applicable;

• Preventive measures, when applicable; and

• HACCP system reassessment, when applicable.

The investigation documentation should also include how the establishment identified all

implicated products and support for the determination. The establishment may wish to

consider factors such as the physical layout of the establishment, Sanitation Standard

Operating Procedures (SOPs), cleaning records, or testing results when developing the

program to identify products that may be implicated by a complaint. The affected

products will depend on the nature of the complaint.

FSIS Regulatory Requirements

Although the customer complaint program described in this guideline is not a regulatory

requirement, the establishment may be required to perform certain actions in response

to a finding of adulterated or misbranded products. Beyond the documentation and

recordkeeping requirements already mentioned, several additional regulations outline

the regulatory requirements an official establishment must meet to prevent direct

contamination or adulteration of products or to respond to a finding of adulterated

products.

If a customer complaint credibly indicates that adulterated or misbranded products have

entered commerce, the establishment must meet the reporting requirements of

9 CFR

418.2 as described in the “FSIS Regulatory Requirements: Notification” section below.

If the outcome of a customer complaint investigation shows that the establishment

produced adulterated products, the establishment must prevent affected products from

entering commerce and, if necessary, remove products which may have already

entered commerce. Depending on the nature and cause of the adulteration and how

that type of adulteration is addressed in the HACCP system, the establishment must

meet any applicable corrective action requirements. These requirements are described

in the “FSIS Regulatory Requirements: HACCP System” section below.

The establishment must also consider any relevant customer complaint findings with

respect to the design of the HACCP system in accordance with these general regulatory

requirements:

Notification

9 CFR 418.2 – “Each official establishment must promptly notify the local FSIS District

Office within 24 hours of learning or determining that an adulterated or misbranded

meat, meat food, poultry, or poultry product received by or originating from the official

establishment has entered commerce, if the official establishment believes or has

reason to believe that this has happened. The official establishment must inform the

District Office of the type, amount, origin, and destination of the adulterated or

misbranded product.”

Hazard Analysis

9 CFR 417.2(a)(1) – “Every official establishment shall

conduct, or have conducted for it, a hazard analysis to

determine the food safety hazards reasonably likely to

occur in the production process and identify the

preventive measures the establishment can apply to

control those hazards. The hazard analysis shall

include food safety hazards that can occur before,

during, and after entry into the establishment.”

Reassessment

9 CFR 417.4(a)(3)(i) – “Every establishment shall

reassess the adequacy of the HACCP plan at least

annually and whenever any changes occur that could

affect the hazard analysis or alter the HACCP plan.

Such changes may include, but are not limited to,

changes in: raw materials or source of raw materials;

product formulation; slaughter or processing methods

or systems; production volume; personnel; packaging;

finished product distribution systems; or, the intended

use or consumers of the finished product. The

24 hours starts when the

establishment has reason to believe

that adulterated or misbranded

products may have entered

commerce

reassessment shall be performed by an individual trained in accordance with §417.7 of

this part. The HACCP plan shall be modified immediately whenever a reassessment

reveals that the plan no longer meets the requirements of §417.2(c) of this part.”

Sanitation SOP

9 CFR 416.12(a) - “The Sanitation SOPs shall describe all procedures an official

establishment will conduct daily, before and during operations, sufficient to prevent

direct contamination or adulteration of product(s).”

Maintenance of Sanitation SOPs

9 CFR 416.14 – “Each official establishment shall routinely evaluate the effectiveness of

the Sanitation SOP's and the procedures therein in preventing direct contamination or

adulteration of product(s) and shall revise both as necessary to keep them effective and

current with respect to changes in facilities, equipment, utensils, operations, or

personnel.”

Sanitation Performance Standards

9 CFR 416.4(d) - “Product must be protected from adulteration during processing,

handling, storage, loading, and unloading at and during transportation from official

establishments.”

Recalls

9 CFR 418.3 - “Each official establishment must prepare and maintain written

procedures for the recall of any meat, meat food, poultry, or poultry product produced

and shipped by the official establishment. These written procedures must specify how

the official establishment will decide whether to conduct a product recall, and how the

establishment will effect the recall, should it decide that one is necessary.”

FSIS Regulatory Requirements: Notification

Once the establishment has reason to believe that adulterated or misbranded FSIS

regulated products have entered commerce, they must notify FSIS as required by

CFR 418.2. The producing establishment must notify the FSIS District Office and the

receiving establishment must notify either the FSIS District Office or FSIS inspection

personnel. Contact information for notification is provided on the webpage

www.fsis.usda.gov contact us. When FSIS personnel notify the official establishment

that adulterated or misbranded products have entered commerce, it would be redundant

for the establishment to also notify the District Office of the same adulterated or

misbranded products and this could result in duplicate cases. Thus, when an

establishment is notified by FSIS personnel that adulterated or misbranded products

have entered commerce, the establishment does not need to notify the FSIS District

Office unless additional product or production dates are involved.

Remember, “in commerce” includes movement between official establishments when

the products are not under direct control of the producing establishment or have left the

direct control of the producing establishment at any point. It is also a good practice to

notify the District Office of the nature of the adulteration or misbranding (e.g., foreign

material contamination, ingredient not present on the label, etc.). The specific nature of

each incident will determine the actions taken by FSIS in response to an official

establishment producing adulterated or misbranded products that entered commerce.

FSIS recommends that the establishment include in the response plan how it will gather

the information required in 9 CFR 418.2

for notification of the District Office when

products have been shipped in commerce.

The information required in 9 CFR 418.2 is:

• Product type

• Amount of implicated products

• Origin

• Destination

When an establishment believes, or has reason to believe, that adulterated or

misbranded products have entered commerce, the establishment must notify FSIS

within 24 hours. The 24-hour period includes weekends or non-workdays. If an

establishment believes, or has reason to believe, that adulterated or misbranded

products have entered commerce on a Friday, they must still report it within 24 hours

even if the establishment does not operate on Saturday. The regulation applies to both

producing and receiving official establishments.

If a producing establishment discovers that their products are adulterated or misbranded

while the products are still under their direct control, they are not required by

9 CFR

418.2 to notify the District Office.

When an establishment is unsure if a finding should be reported to FSIS, they should

ask Inspection Program Personnel (IPP) or the District Office for clarification.

9 CFR 418.2 vs. FSIS Directive 8140-1

The regulatory requirement in 9 CFR 418.2

to notify the District Office when adulterated

or misbranded products have entered commerce applies to official establishments. This

regulatory requirement is separate from the instruction to FSIS inspection personnel

found in

FSIS Directive 8140.1, Notice of Receipt of Adulterated or Misbranded Product.

FSIS Directive 8140.1 instructs FSIS personnel to use an internal notification tool when

adulterated or misbranded products have moved between establishments, even if those

products have not entered commerce. The instructions in

FSIS Directive 8140.1

concern verification of existing recordkeeping regulations (9 CFR part 320, 416.16,

417.5, and 418.4) and do not create a new notification requirement for establishments.

FSIS personnel are responsible for gathering information, completing FSIS Form 8140-

1, and following the instructions in

FSIS Directive 8140.1. The establishment is

responsible for meeting the regulatory requirement as described in 9 CFR 418.2 and for

providing information when requested by FSIS personnel to complete FSIS Form 8140-

1. The notification requirements for the receiving and producing establishments are

further discussed below.

Responsibilities at the Receiving Establishment

When an establishment receives adulterated or misbranded products and the products

have entered commerce, the receiving establishment must notify FSIS in accordance

with 9 CFR 418.2

. The receiving establishment may notify the District Office directly

using the contact information provided on the FSIS Contact Us page or notify IPP. If the

receiving establishment elects to notify IPP instead of the District Office, then IPP will

complete a paper or digital FSIS Form 8140-1 to notify IPP at the shipping/producing

establishment and the applicable District Offices. Notification should only be done using

official FSIS email addresses, phone numbers for FSIS offices, FSIS programs such as

PHIS, and FSIS issued electronic devices.

NOTE: The receiving establishment is required per 9 CFR 418.2 to either notify the

District Office directly or IPP, but not both.

Even though FSIS will provide a copy of FSIS Form 8140-1 to the producing

establishment, FSIS recommends that the receiving establishment notify the producing

establishment to expedite the producing establishment’s investigation.

Responsibilities at the Producing Establishment

The producing establishment must provide notification to the District Office consistent

with 9 CFR 418.2

when they have reason to believe adulterated or misbranded product

has entered commerce. The producing establishment may find out about the

adulterated or misbranded products directly from the receiving establishment, from a

customer, or from local IPP. The producing establishment must notify its District Office

within 24 hours of learning or determining that adulterated or misbranded products have

entered commerce. Learning of the event provides an establishment reason to believe

that adulterated or misbranded products have entered commerce and a final

investigation does not need to be completed before FSIS notification. When the

producing establishment receives a customer complaint from a location other than an

official establishment (e.g., state inspected establishment, retail store, restaurant,

household consumer, foreign establishment, foreign consumer, etc.) that indicates

adulterated or misbranded products have entered commerce, then the producing

establishment is solely responsible for the notification of the District Office.

NOTE: When FSIS personnel at the producing establishment receive e-mail notification

from the District Office of products that have been shipped in commerce and discuss

the report with the producing establishment, the producing establishment is not required

to provide any additional notification to the District Office under 9 CFR 418.2

, unless

they identify additional implicated products. IPP will verify the producing

establishment’s corrective actions according to the instructions in

FSIS Directive

5000.1, Verifying an Establishment’s Food Safety System.

When adulterated or misbranded products have entered commerce, the Agency may

determine the need to convene the Health Hazard Evaluation Board (HHEB) as per

FSIS Directive 8091.1

, Procedures for the Food Safety and Inspection Service (FSIS)

Health Hazard and Evaluation Board (HHEB). The HHEB may be convened if there are

circumstances that require further evaluation. Additionally, factors that are considered

by the FSIS recall committee in evaluation of the public health significance of an

undeclared ingredient in meat or poultry products are described in Attachment 2 of FSIS

Directive 8080.1, Recall of Meat and Poultry Products. An establishment may wish to

use FSIS Directive 8080.1 as a reference when developing its customer complaint

program and when determining when a food safety hazard exists. Attachment 2 is

specific to ingredients, but a similar thought process could be used to assess foreign

materials, other contamination, and misbranding.

FSIS Regulatory Requirements: HACCP System

Does a customer complaint impact the establishment’s HACCP System?

One part of responding to a customer complaint is determining what aspect of the

establishment’s programs failed to prevent the adulterated or misbranded products from

entering commerce. The establishment’s HACCP system consists of the plans,

programs, measures, and procedures that are implemented to prevent, eliminate, or

control identified food safety hazards and other adulteration in their products. The

HACCP system includes the HACCP plan and Sanitation SOPs, prerequisite programs,

and other plans in operation at an establishment to prevent products from becoming

adulterated. Each establishment should customize the program for their unique

products, operations, and system.

The establishment’s HACCP system should function to prevent any adulterated

products from entering commerce, even if the cause of the adulteration is not a food

safety hazard (e.g., it does not result in a food to be unsafe for human consumption).

For example, an establishment may determine that a specific foreign material does not

pose a physical or chemical food safety hazard in the product; however, the presence of

the foreign material in a food causes that food to be adulterated and unfit for human

consumption. Each establishment must prevent human food containing foreign material

from entering commerce through the proper design and implementation of its HACCP

system. 9 CFR 417.6

indicates that an establishment’s HACCP system may be

inadequate if the establishment produced or shipped adulterated products. In addition,

9 CFR 500.3 authorizes FSIS to withhold the mark of inspection or suspend inspection

when an establishment has produced and shipped adulterated or misbranded products.

Corrective Action Requirements

When adulterated products have been produced, the establishment must determine

what part of the HACCP system failed to allow products to become adulterated. The

incident may have occurred because of a deficiency in the Sanitation SOPs, HACCP

plan, or a prerequisite program. The system must be evaluated to determine if safe and

wholesome products can still be produced under the existing system or if modifications

must be made. The specific requirements for corrective actions depend on which part

of an establishment’s HACCP system addresses foreign materials as described below.

The HACCP regulations require corrective actions when a food safety hazard occurs (9

CFR 417.3). 9 CFR 417.3(a) describes the corrective actions that apply when the

establishment determines that the adulterated products represent a deviation from a

critical limit and states, “The written HACCP plan shall identify the corrective action to

be followed in response to a deviation from a critical limit. The HACCP plan shall

describe the corrective action to be taken, and assign responsibility for taking corrective

action, to ensure: (1) The cause of the deviation is identified and eliminated; (2) The

CCP will be under control after the corrective action is taken; (3) Measures to prevent

recurrence are established; and (4) No product that is injurious to health or otherwise

adulterated as a result of the deviation enters commerce.” The second part of the

regulation, 9 CFR 417.3(b) describes the corrective actions that apply when the

establishment determines that the adulterated products represent an unforeseen food

safety hazard and states, “(b) If a deviation not covered by a specified corrective action

occurs, or if another unforeseen hazard arises, the establishment shall: (1) Segregate

and hold the affected product, at least until the requirements of paragraphs (b)(2) and

(b)(3) of this section are met; (2) Perform a review to determine the acceptability of the

affected product for distribution; (3) Take action, when necessary, with respect to the

affected product to ensure that no product that is injurious to health or otherwise

adulterated, as a result of the deviation, enters commerce; (4) Perform or obtain

reassessment by an individual trained in accordance with §417.7 of this part, to

determine whether the newly identified deviation or other unforeseen hazard should be

incorporated into the HACCP plan.”

If the establishment determines that the

adulteration does not represent a food safety

hazard, the Sanitation SOP regulations describe

the corrective actions that must be performed:

“Each official establishment shall take appropriate

corrective action(s) when either the establishment

or FSIS determines that the establishment's

Sanitation SOP's or the procedures specified

therein, or the implementation or maintenance of

the Sanitation SOP's, may have failed to prevent

direct contamination or adulteration of product(s).

Corrective actions include procedures to ensure

appropriate disposition of product(s) that may be

contaminated, restore sanitary conditions, and

prevent the recurrence of direct contamination or

adulteration of product(s), including appropriate

reevaluation and modification of the Sanitation

SOP's and the procedures specified therein or

appropriate improvements in the execution of the

Sanitation SOP's or the procedures specified

therein” (9 CFR 416.15).

It is important to consider each customer complaint on a case-by-case basis. When a

complaint is reported, the establishment must determine if a food safety hazard exists.

If a food safety hazard has occurred, the establishment must address the regulatory

requirements for HACCP corrective actions in 9 CFR 417.3 and records as required in

CFR 417.5. If a food safety hazard does not exist, the products may still be adulterated,

and the establishment must react accordingly. If no food safety hazard exists, the

regulatory requirements for adulterated products in 9 CFR 416.15 and 9 CFR 416.16

Reassessment:

A HACCP reassessment is required

when an establishment is

performing corrective actions for an

unforeseen hazard or when a

change occurs that impacts the

Hazard Analysis or HACCP plan.

A Sanitation SOP must be revised as

necessary to keep them current and

effective in preventing direct

contamination or adulteration of

the products.

apply. Either way, when adulterated products have been produced and shipped, the

establishment must implement a corrective action. The specific corrective action

requirements are determined by the applicable regulation.

HACCP corrective actions

If a food safety hazard posed by foreign material was previously identified as

reasonably likely to occur (RLTO), a CCP was established to prevent the hazard from

entering commerce, and the hazard then does occur in products in commerce, the

establishment must implement corrective actions as described in 9 CFR 417.3(a)

If the food safety hazard posed by the foreign material was identified through the hazard

analysis as not reasonably likely to occur (NRLTO) due to a prerequisite program, but it

does occur and foreign material entered commerce, then it would be an unforeseen

hazard and the establishment must perform corrective actions as described in

9 CFR

417.3(b). This corrective action requirement includes a reassessment to determine if

the decision in the hazard analysis is still supportable or if changes need to be made.

HACCP corrective actions must be documented as described in

9 CFR 417.5.

If products are adulterated and in commerce but the cause of the adulteration (e.g.,

foreign material) is determined not to be a food safety hazard, the establishment must

still evaluate the efficacy of its HACCP system. Adulterated products that have been

produced or shipped may indicate an inadequate HACCP system.

Sanitation SOP corrective actions

Sanitation SOPs must be designed to prevent the contamination or adulteration of

products as outlined in 9 CFR 416.12(a)

. When adulterated food products are found in

commerce, the Sanitation SOP may have failed to prevent adulteration of products and

the establishment must perform corrective actions as described in

9 CFR 416.15 and

document the corrective actions as described in 9 CFR 416.16. The 9 CFR 416.15

Sanitation SOP corrective action regulation applies when adulterated food products

have been produced and shipped even when the program that failed is not specifically

included in the Sanitation SOPs (e.g., equipment maintenance, employee tool sign-out).

The establishment will have to determine if the programs need to be incorporated into

the Sanitation SOPs in order to prevent future adulteration as part of the routine

evaluation of Sanitation SOPs described in

9 CFR 416.14.

Misbranding corrective actions

The establishment must not discount misbranding as a labeling issue alone, since

misbranding may result in a food safety hazard. One example of misbranding that is

also a food safety hazard is when allergens are present but undeclared on the label.

When an establishment determines that misbranded products have entered commerce,

it is to notify the District Office, as required by 9 CFR 418.2.

Misbranding events may

require relabeling; the establishment should consult with the FSIS Office of Policy and

Program Development (OPPD) Labeling and Program Delivery Staff (LPDS) to

determine how to correct or replace the inaccurate labels. Certain misbranded products

may be eligible for donation. Misbranded and economically adulterated meat and

poultry products can be donated provided the label does not contain any undeclared

ingredients of public health concern as described in FSIS Directive 7020.1, Verifying

Donation Of Misbranded And Economically Adulterated Meat And Poultry Products To

Non-Profit Organizations.

Other Actions

Each establishment should be proactive in response to any adulteration or misbranding

event, evaluate how the affected products were adulterated or misbranded, why they

were shipped undetected, and assess the HACCP system for any other vulnerability.

For example, if a piece of plastic in a food product is determined to be from a single

conveyor belt, the establishment should consider whether it is an isolated incident.

FSIS believes the best practice would be to re-inspect all belts and reevaluate the

preventive maintenance program and controls that failed to detect the faulty belt

resulting in adulterated products. The establishment should consider replacing gaskets,

belts, screens, and other loose items with components that are detectable (e.g., bright

color, radiolucent). Increased lighting, employee training, and enhanced screening of

raw material are some additional corrective actions that may produce a meaningful

result. Any corrective action should prevent additional adulterated or misbranded

products from being produced at the establishment.

Diversion to pet food as a corrective action

If an establishment determines that adulterated products are not logistically or

practically eligible for rework to be made unadulterated, then the products are inedible

and must be handled as inedible materials in accordance with FSIS regulatory

requirements (9 CFR 325.11, 381.193

). In some cases, inedible materials can be sent

to a pet food manufacturer. However, because pet food production is under the

jurisdiction of the FDA, the establishment is cautioned to check with the manufacturer or

the FDA prior to sending the adulterated products to the pet food facility. Some types of

adulteration are not eligible for pet food and are not permitted by FDA to be sent for pet

food. If the products are not eligible for pet food, the remaining options are rendering or

a landfill. Please note that rendering companies may not be willing to accept products

adulterated with foreign material if the materials will damage the equipment. The

establishment is encouraged to verify that the products will be accepted by the renderer.

Suggested Tips

Follow these tips when writing a customer complaint program:

• Provide customers with a method to notify you:

– Consider the impact of co-packing or products produced in

multiple establishments

– Provide multiple modes of communication: email, telephone,

mail, etc.

• Facilitate the substantiation of any complaint:

– Pay to have a label or foreign material mailed to you

– Ask questions to gather as much information as possible

– Develop investigation SOPs

• Identify establishment and FSIS personnel who need to be notified and

provide the contact information in the document, so you don’t have to

look for it later:

– District Office contact information is available on the Contact Us

page of www.fsis.usda.gov

– Inspection personnel office phone numbers are available to the

individual establishment

• Evaluate the HACCP system and relevant programs;

• Document findings and make them available to FSIS upon request;

• Consider that the complaint may indicate a larger issue;

• Be proactive.

– Put procedures in place now to prevent adulteration

Example Flow Diagram of a Customer Complaint

References:

REGULATIONS

United States Department of Agriculture, Food Safety and Inspection Service. 2012. Notification. 9

CFR Part 418.2.

United States Department of Agriculture, Food Safety and Inspection Service. 2012. Preparation and

maintenance of written recall procedures. 9 CFR Part 418.3.

United States Department of Agriculture, Food Safety and Inspection Service. 1971. Reinspection,

retention, and disposal of meat and poultry products at official establishments. 9 CFR Part 318.2

United States Department of Agriculture, Food Safety and Inspection Service. 1970. Handling and

disposal of condemned or other inedible products at official establishments. 9 CFR Part 314.

United States Department of Agriculture, Food Safety and Inspection Service. 1970. Transportation.

9 CFR Part 325.

United States Department of Agriculture, Food Safety and Inspection Service. 1972. Disposal of

condemned poultry products. 9 CFR Part 381.95.

United States Department of Agriculture, Food Safety and Inspection Service. 1984. Poultry

carcasses, etc., not intended for human food. 9 CFR Part 381.193.

United States Department of Agriculture, Food Safety and Inspection Service. 1970. Definitions.

CFR Part 301.2.

United States Department of Agriculture, Food Safety and Inspection Service. 2014. Definitions.

CFR Part 381.1.

United States Department of Agriculture, Food Safety and Inspection Service. 2014. Sanitation.

CFR Part 416.

United States Department of Agriculture, Food Safety and Inspection Service. 2014. Hazard Analysis

and Critical Control Point (HACCP) Systems. 9 CFR Part 417.

DIRECTIVES

FSIS Directive 8080.1

, RECALL OF MEAT AND POULTRY PRODUCTS

FSIS Directive 8140.1, NOTIFICATION OF ADULTERATED OR MISBRANDED PRODUCT

FSIS Directive 8091.1, PROCEDURES FOR THE FOOD SAFETY AND INSPECTION SERVICE (FSIS) HEALTH

HAZARD AND EVALUATION BOARD (HHEB)

FSIS Directive 7020.1, VERIFYING DONATION OF MISBRANDED AND ECONOMICALLY ADULTERATED

MEAT AND POULTRY PRODUCTS TO NON-PROFIT ORGANIZATIONS

Helpful Websites (Control + click to be directed to website)

Food Safety and Inspection Service (FSIS)-

FSIS homepage: http://www.fsis.usda.gov/wps/portal/fsis/home

How to Develop a Meat and Poultry Product Recall Plan:

https://www.fsis.usda.gov/shared/PDF/RecallPlanBooklet_0513.pdf

The Physical Hazards of Foreign Materials, Presentation at Public Meeting on Foreign Material

Contamination, September 24, 2002, David P. Goldman, MD, FSIS

https://www.fsis.usda.gov/wps/portal/fsis/newsroom/speeches-

presentations/archive/presentations/ct_index999

Food and Drug Administration (FDA)-

FDA Compliance Policy Guide, CPG Sec 555.425 Foods, Adulteration Involving Hard Sharp Foreign

Objects

http://www.fda.gov/ICECI/ComplianceManuals/CompliancePolicyGuidanceManual/ucm074554.htm

Red Meat and Poultry Industry Guidance-

Industry Best Practices for Customer Complaints of Foreign Material in Meat and Poultry Products,

August 2018.

https://www.nationalchickencouncil.org/wp-content/uploads/2018/08/Foreign-Material-Best-

Practices_Aug2018.pdf

http://askfsis.custhelp.com/

FSIS/USDA

www.fsis.usda.gov

2020