CHAPTER I - GENERAL

I. PURPOSE

This directive provides the terminology, responsibilities, and public notification procedures regarding the voluntary recall of FSIS inspected meat and poultry products.

II. CANCELLATION

FSIS Directive 8080.1, Revision 6, Recall of Meat and Poultry Products dated 10/26/10

III. REASON FOR REISSUANCE

This directive is being reissued in its entirety to provide guidance regarding recall plans and to incorporate new regulations that address the following:

1. Official establishments are required to notify their local FSIS District Office (DO) personnel within 24 hours when they learn or determine that adulterated or misbranded product has entered commerce.
2. If an official establishment notifies FSIS personnel other than the DO that adulterated or misbranded product has entered commerce, those personnel are to contact the DO promptly, through supervisory channels. They are also to notify the establishment that it is still required to contact the DO directly.

IV. BACKGROUND

A. A recall is a firm’s action to remove product from commerce to protect the public from consuming adulterated or misbranded products. Although it is a firm’s decision to recall product, FSIS coordinates with the firm to ensure it has properly identified and removed recalled product from commerce by verifying the effectiveness of the firm’s recall activities. FSIS also notifies the public about product recalls.

B. A recall may be an alternative to FSIS detention or seizure of adulterated or misbranded products. However, a recall does not preclude FSIS from taking other appropriate actions, such as issuing Public Health Alerts or performing product detentions and seizures, to mitigate the risk to the public when firms have inadequately removed recalled product from commerce. The Agency will investigate if it appears that a firm’s recall strategy or execution of that strategy is ineffective. Based on its findings, FSIS may seek enforcement action against the recalling firm or its consignees.

C. For recalls conducted by State-inspected firms or retail establishments, the appropriate State agency verifies the recall, in most cases. If requested to do so, FSIS will provide the State agencies with appropriate assistance and information.

NOTE: Recall procedures for meat and poultry products produced in an establishment operating under the Cooperative Interstate Shipment program are addressed in FSIS Directive 5740.1, Cooperative Interstate Shipment Program.

D. When FSIS finds that imported product should be recalled, the Agency will request that the importer of record recall the product. The importer of record would be responsible for recovering the product involved and properly disposing of the affected product.

V. TERMINOLOGY

Recall: A firm’s removal of distributed meat or poultry products from commerce when there is reason to believe that such products are adulterated or misbranded under the provisions of the FMIA or the PPIA. "Recall" does not include a market withdrawal or a stock recovery.

Market Withdrawal: A firm's removal or correction, on its own initiative, of a distributed product that involves a minor company quality program or regulatory program infraction that would not result in the product being adulterated or misbranded. For example, product does not meet company quality standards because of discoloration.

Stock Recovery: A firm's removal or correction of product that has not been marketed or that has not left the direct control of the firm. For example, product is located on the premises owned by the producing firm or under its control.

Recall Classifications: FSIS assesses the public health concern or hazard presented by a product being recalled, or considered for recall, whether firm-initiated or requested by FSIS, and classifies the concern as one of the following:

1. Class I: This is a health-hazard situation where there is a reasonable probability that the use of the product will cause serious, adverse health consequences or death. Examples of a Class I recall include the presence of pathogens in ready-to-eat meat or poultry products, or the presence of E. coli O157:H7 or non-O157 Shiga toxin-producing E. coli (STECs) in raw ground beef.
2. Class II: This is a health-hazard situation where there is a remote probability of adverse health consequences from the use of the product. An example of a Class II recall is a recall because of the presence in a product of very small amounts of undeclared allergens typically associated with milder human reactions, e.g., wheat.
3. Class III: This is a situation where the use of the product will not cause adverse health consequences. An example of a Class III recall is the presence of undeclared, generally recognized as safe, non-allergenic substances, such as excess water in meat or poultry products.

Depth of Recall: The level of product distribution to which the recall is to extend:

1. Wholesale level: The product has been distributed to a warehouse or distribution center where it is not under the direct control of the producing company. This is the distribution level between the manufacturer and the retailer. This level may not be encountered in every recall situation (i.e., the recalling firm may sell directly to the retail or consumer level.)
2. Retail level: The product has been received by retailers for sale to household consumers.
3. HRI level: The product has been received by hotels, restaurants, and other institutional customers.
4. Consumer level: The product has been sold directly to household consumers.

Scope: This defines the amount and type of product in question. Several factors are used in determining the scope of a recall, such as the plant’s processing and sanitation procedures, the definition of a lot, or specific grouping, and whether there is any finished product reincorporated into fresh product (rework). The findings of epidemiological investigations that link certain lots of product with known cases of foodborne illnesses may also affect the scope of a recall.

Disposition: This is the firm's action with respect to the recalled product to correct the situation leading to the recall, such as relabeling, cooking, reworking, or destroying product.

Health Hazard Evaluation Board (HHEB): The HHEB is the primary group in FSIS that reviews the public health significance of any human health hazard about which a regulatory decision needs to be made. If the risk to the public health presented by a given product appears to be unique or in some way unusual, the Recall Committee may consult the Office of Public Health Science’s (OPHS) HHEB. (See FSIS Directive 8091.1, Procedures for the FSIS Health Hazard Evaluation Board.)

Recall Committee: A committee of representatives from various FSIS offices and staffs assembled to respond to potential or real health hazard incidents reported to the Recall Management and Technical Analysis Staff (RMTAS).

CHAPTER II – DETERMINING NEED FOR RECALL

I. BECOMING AWARE OF POTENTIAL NEED FOR A RECALL

A. When official establishments learn or determine that adulterated or misbranded product has entered commerce, they are required to notify FSIS DO personnel within 24 hours (9 CFR 418.2). If an official establishment notifies FSIS personnel other than the DO that adulterated or misbranded product has entered commerce, those personnel are to contact the DO promptly, through supervisory channels. They are also to notify the establishment that it is still required to contact the DO directly.

B. FSIS has informed other firms, including importers of record, that when they learn or determine that adulterated or misbranded product has entered commerce or decide to recall product on their own initiative, they are to immediately notify RMTAS or other FSIS personnel. However, if the firm contacts other FSIS personnel, those employees are to promptly contact RMTAS through supervisory channels.

C. FSIS may become aware of misbranded or adulterated product in commerce through its own resources and personnel activities or through other sources outside of FSIS. For example, FSIS may receive information from:

1. The company that manufactures, distributes, or receives the product;
2. Test results from FSIS sampling programs;
3. Observations or information gathered by FSIS inspection program personnel (IPP) in the course of their routine duties or investigations;
4. Consumer complaints reported through the FSIS Consumer Complaint Monitoring System (CCMS);
5. Epidemiological or laboratory data submitted by State or local public health departments, other USDA agencies, and other Federal agencies such as the Food and Drug Administration (FDA), the Centers for Disease Control and Prevention (CDC), or the Department of Defense; or
6. Information from other agencies such as the Department of Homeland Security, Customs and Border Protection, the Animal and Plant Health Inspection Service, or foreign inspection officials.

II. PRELIMINARY INQUIRY

A. When FSIS learns that there is reason to believe that adulterated or misbranded product is in commerce, FSIS will conduct a preliminary inquiry. The Recall Officer (RO) is assigned to direct the activities of IPP. FSIS personnel are to begin the preliminary inquiry by gathering product information, contact information, and any additional relevant information. They are to forward the following to RMTAS:

1. Contact Information for an Official Establishment:

• a. Establishment number, name, and address;
• b. Company Recall Coordinator (name, title, and telephone number);
• c. Company Media Contact (name, title, and telephone number); and
• d. Company Consumer Contact (name, title, and telephone number).

2. Contact Information for Imported Products:

• a. Import establishment (number, name, address, and telephone number);
• b. Foreign establishment (number, name, address, and telephone number);
• c. Importer of Record (name, address, and telephone number);
• d. Importer of Record Company’s Recall Coordinator (name, title, and telephone number);
• e. Importer of Record Media Contact (name, title, and telephone number); and
• f. Importer of Record Consumer Contact (name, title, and telephone number).

3. Product Information: For all products, including imported products, FSIS personnel are to gather the following product information:

• a. Reason for recall;
• b. Brand names;
• c. Product names;
• d. Packaging (Type & Size (pounds));
• e. Package codes (Use by/Sell by);
• f. Packaging dates;
• g. Photos of label or package;
• h. Case codes;
• i. Count/case;
• j. Production dates;
• k. Distribution areas;
• l. School lunch (yes/no);
• m. Department of Defense (yes/no); and
• n. Internet or catalog sales (yes/no).

4. Additional Product Information for Official Establishments:

• a. Amount produced (pounds);
• b. Amount held at establishment;
• c. Amount distributed (pounds/cases); and
• d. Distribution level (depth of the recall, if known).

5. Additional information for Imported Product:

• a. Amount imported (pounds/cases);
• b. Amount held at import establishment;
• c. Amount distributed (pounds/cases);
• d. Distribution level (depth of the recall, if known); and
• e. Foreign country notified (yes/no).

6. When appropriate:

• a. Violation reported to Import/Export Coordination and Policy Development Staff (yes/no);
• b. Health Hazard Evaluation Board (HHEB) convened (yes/no); and
• c. Emergency Coordination Staff (EMS) notified (yes/no).

B. During the preliminary inquiry, FSIS personnel are to gather additional information by taking the following steps, as necessary:

1. Collecting and verifying information about suspect product;
2. Documenting a chronology of events;
3. Contacting the company that manufactures or distributes the product for additional information;
4. Communicating with FSIS field inspection and FSIS enforcement personnel;
5. Interviewing any consumer who allegedly became ill or was injured from eating suspect product;
6. Collecting and submitting product samples for analysis;
7. Contacting other agencies, State and local health departments, or foreign governments;
8. Analyzing any available epidemiological data;
9. Reviewing supporting documentation and evidence (e.g., sanitation standard operating procedures, or HACCP and production records).

C. RMTAS is to collect all of the information gathered during the preliminary inquiry and forward the relevant materials to the Recall Committee. Firms are encouraged to submit product label information electronically, whenever possible, to minimize transcription errors and enable consignees and consumers to readily identify recalled product if FSIS must issue a Recall Release.

CHAPTER III – RECALL COMMITTEE

I. RECALL COMMITTEE MEMBERS

A. All members of the recall committee should be knowledgeable about the issues raised by a potential recall situation and should be empowered by their Assistant Administrator (AA) to represent his/her views. Committee members are to make every effort to achieve consensus on whether to recommend that the Agency request a recall. The primary members of the Committee and their roles are described below:

1. Recall Management and Technical Analysis Staff (RMTAS), Office of Field Operations (OFO) - (chairperson) - Calls a committee meeting and distributes information about the potential recall to committee members. Invites other FSIS program areas to assist as necessary.
2. FSIS Recall Officer (RO), OFO - Clarifies and explains to the Committee the information collected during the preliminary inquiry. Designated FSIS personnel with jurisdiction in the district of the firm that is conducting the recall are to serve as the RO. The RO is the official responsible for coordinating field recall activities and providing direction to IPP when there is recall.
3. Office of Policy and Program Development (OPPD) – Provides the statutory basis for each recall. OPPD also addresses other statutory issues, the regulations, and any regulatory policies that are relevant to the recall.
4. Office of Public Health Science (OPHS) - Addresses microbiological, epidemiological, and other scientific issues associated with the recall.
5. Congressional and Public Affairs Office (CPAO) (Media Relations), Office of Public Affairs and Consumer Education (OPACE) - Gathers information and generates a Recall Release or Recall Notification Report (RNR) if there is a recall. Gathers information and, when appropriate, generates public notification, such as a Public Health Alert or Press Release, in situations where a recall action is not warranted. Ensures that information contained in the Recall Release, RNR, Public Health Alert, or Press Release is accurate.
6. In addition, the Committee may also consist of representatives from the following program areas, at RMTAS’s request:

• a. Office of Investigation, Enforcement and Audit (OIEA), Compliance and Investigations Division (CID): Participates in committee meetings and provides assistance to OFO upon request. CID also conducts investigations of alleged criminal violations, such as those involving the sale, transport, or receipt of adulterated product, associated with the recall.
• b. Office of Data Integration and Food Protection: A representative from ODIFP is invited to all Recall Committee meetings to participate as a non-voting member.
• c. Other Federal or State agencies, as appropriate (e.g., FDA, Food and Nutrition Service, CDC, Office of the General Counsel, State departments of public health).

II. DELIBERATIONS OF THE RECALL COMMITTEE

A. To convene the Recall Committee, RMTAS is to contact the Committee members, usually by e-mail, to inform them of the potential recall. RMTAS is to provide the time of the recall meeting and a conference call number so that the Committee members can call into the meeting at the designated time. RMTAS is to make every effort to ensure that the five (5) primary members of the Recall Committee are available to participate in the Recall Committee meeting.

B. After RMTAS convenes the Recall Committee, the members are to discuss the reason that a particular product may need to be removed from commerce and whether there is a statutory basis to recommend a recall. If the Recall Committee decides to recommend a recall, it is to also determine the appropriate recall classification.

C. When determining whether to recommend a product recall, the Recall Committee is to seek the answers to the following questions:

1. Does FSIS have reason to believe that the product in question is adulterated or misbranded under the FMIA or PPIA? For Example:

• a. If the results of a laboratory analysis show that raw ground beef or beef manufacturing trimmings contains E. coli O157:H7, or that a ready-to-eat product contains Listeria monocytogenes, the product is clearly adulterated because it is likely to be injurious to health.
• b. However, there may be situations in which laboratory results are not available or are inconclusive, but, that FSIS believes, on the basis of epidemiological evidence, that a specific meat or poultry product is associated with human illnesses. Under these circumstances, the Recall Committee is to consider the strength of the epidemiological evidence to determine whether there is a basis to conclude that a product contains a pathogen or is otherwise unhealthful and, therefore, adulterated.

2. Does any of the product in question remain in commerce or available to consumers?

• a. Domestic product is considered in commerce if it has been shipped from an establishment without Agency or establishment controls or restrictions and is free to be moved to any consignee or to consumers.
• b. Imported product is considered in commerce if it has moved, resulting in a change of ownership from the importer of record that presented the product for FSIS reinspection at the official import inspection establishment to any other entity prior to receipt of laboratory results, or if the importer of record has relinquished ownership of the product before receiving the laboratory results.
• c. The Recall Committee and program employees are to consider all available information to determine whether product is in commerce, and whether any product that has been distributed in commerce has reached retail facilities, restaurants, or consumers.

D. If the Recall Committee finds that the establishment has recovered all products from commerce that would have been subject to recall, the Committee should not recommend a recall, as no product should remain available to consumers. Instead, FSIS personnel are to verify that the establishment has recovered all products involved and that it conducted proper disposition of the affected products.

E. To properly assess whether any of the product remains available to consumers, the Recall Committee is to seek responses to the following probing questions:

1. When was the product produced?
2. To whom has the product been distributed?
3. What type of product is involved (e.g., ready-to-eat, fresh packed, canned, frozen)?
4. What is the typical, usable shelf life of the product?
5. What are the typical consumer or user practices concerning handling and storing of the product in question (e.g., is the product typically prepared for immediate consumption and likely is not stored or frozen for later use)?
6. Is the Agency able to verify that the product that was distributed in commerce is no longer available to consumers at retail facilities, restaurants, or other institutions?

F. If the answers to the questions C.1. and 2. are “yes,” a recall should be recommended, unless, based on the answers to questions in paragraph E, the Committee determines that the product is long out of date and unlikely still to be available to consumers, or the Committee is unable to identify a responsible party for the product. In these circumstances, a recall should not be recommended. However, the Agency may decide to issue a Public Health Alert. See Chapter IV for information regarding Public Health Alerts.

G. If a Recall Committee member does not agree with the action that a majority of the committee has decided to recommend, the dissenting member should immediately discuss the issue with his or her AA and report back to the Committee. If the Recall Committee is unable to come to consensus, the RMTAS representative is to notify the OFO AA, who will convene a meeting of the AAs and advise the Administrator that he or she is convening the meeting. Each AA should discuss the potential recall with his or her Office’s representative to the Recall Committee or their designee. If the AAs are unable to resolve the matter, they are to report the situation as a potential significant incident to be resolved by the Emergency Management Committee (EMC), as provided in FSIS Directive 5500.2, Significant Incidence Response.

H. If the Recall Committee agrees that a recall is not recommended, RMTAS is to document the results of the preliminary inquiry and evaluation with a Memo to the File.

I. If the Recall Committee agrees to recommend a recall, it is to consider the human health hazard presented by the product subject to recall to determine the appropriate recall classification. Typically, there are precedents for determining the significance of the health hazard presented by an adulterated product and the classification of the hazard. The Recall Committee will be guided by these precedents in classifying recalls. However, if the Recall Committee has questions, particularly about hazards or conditions that have not been previously encountered by the Agency, the HHEB will be convened to conduct a hazard evaluation. The HHEB’s evaluation will consider, at a minimum, the following factors:

1. The nature of the problem (i.e., what is the problem with the product and what health hazards does the problem create);
2. The occurrence of any illnesses or injuries;
3. The likelihood that illnesses or injuries may result; and
4. The types of illnesses or injuries that may result.

J. The Committee may also refer to “Factors That Are Considered by the FSIS Recall Committee in Evaluating the Public Health Significance of an Undeclared Ingredient in a Meat or Poultry Product” (Attachment 2) when considering the classification of a recall that involves a meat or poultry product that contains an ingredient that is not declared on the product labeling.

K. After the Committee members have discussed the issues described in the above paragraphs, and agreed to recommend a recall, RMTAS is to contact the company that produced the product to allow its representatives to join the Recall Committee discussion. During the discussion, the Recall Committee is to allow the firm to present information about the hazard or concern associated with the product to allow the Committee to clarify its position. The Committee is to evaluate all information received and determine whether to recommend a recall of the product. FSIS expects the firm to have available upon request its recall strategy, including how it intends to notify and instruct its consignees to retrieve or dispose of the recalled product.

III. RECALL RECOMMENDATION

A. When the Recall Committee recommends a recall, RMTAS is to submit a Recall Recommendation in the form of a memo for approval by the OFO AA. The recommendation is to contain:

1. The reason for the recall, including why there is a reason to believe that the product is adulterated or misbranded;
2. The recall classification (i.e., Class I, Class II, or Class III);
3. The ability of distributors, consumers, or users of the product to identify the products covered by the recall; and
4. The estimated amount of recalled product in distribution (the amount of product subject to recall that was distributed. In some cases, not all of the product in distribution will be recalled because some of it will be beyond the sell by/use by dates or codes at the time of recall. In these cases, the Recall Committee is to determine whether consumers might still have the product, and, if so, whether they would possibly consume it).

B. The Recall Committee generally determines much of the above information from the recalling firm through written documents or telephone conference calls. Before deciding on a recommendation, RMTAS may request that FSIS IPP verify the information provided by the firm. RMTAS is to strongly encourage firms to e-mail the information involved in the recall to facilitate the speed and accuracy of the information transfer.

C. If the OFO AA approves the Recall Recommendation, RMTAS is to follow-up by sending a letter to the firm confirming the evaluation of the hazard, the scope of the recall, the area of distribution and the Agency’s understanding of the firm’s recall strategy. If the OFO AA does not approve the Recall Recommendation, the OFO AA is to convene the AAs to discuss and resolve whether to request a recall. Each AA should discuss the potential recall with his or her Office’s representative to the Recall Committee. If the decision is made to request a recall, CPAO is to confirm the information necessary for a Recall Release. The OPACE AA may request that other AAs review the draft Recall Release before it is issued. The RO is to begin to coordinate effectiveness checks (see Chapter V), consistent with the class of the recall, and is responsible for directing the activities of FSIS IPP.

D. If product subject to recall has been exported to a foreign country, RMTAS is to notify the relevant FSIS personnel. FSIS will inform the foreign country of the recall.

CHAPTER IV - ANNOUNCING THE RECALL

I. ACTION BY FIRM

A. FSIS outlines in “Product Recall Guidelines for Firms” (Attachment 3) the actions a firm can take to ensure that it recovers the maximum amount of product in the shortest amount of time. This guidance includes information on complying with recordkeeping requirements and a model letter that a firm may use to communicate with its consignees.

B. If the firm decides not to accept the Agency’s recommendation and chooses not to conduct a recall, FSIS personnel are to detain any product found in commerce that would have been subject to a recall as set out in FSIS Directive 8410.1, Detention and Seizure. CPAO is to issue a Press Release informing the public that product that appears to be adulterated or misbranded has been shipped by the responsible firm and that the Agency is detaining product in commerce.

II. PUBLIC NOTIFICATION

A. Following approval of the recall by the OFO AA, RMTAS notifies CPAO to issue a Recall Release. CPAO is to distribute the Recall Release to media wire services, media outlets in areas that received recalled products, the FSIS e-mail subscription service, and the @USDAfoodsafety Twitter Feed. CPAO will also post it on the FSIS website. Generally, FSIS will issue a Recall Release for Class I and Class II recalls. However, if the recalled product has not been distributed beyond the wholesale level and has only been sent to warehouses or distribution centers where it is not likely to be sold directly to consumers, a Recall Release would not be necessary, even for Class I or Class II recalls. Instead, the Agency would issue an RNR (see section III below). FSIS will typically not issue a Recall Release for Class III recalls unless there are overriding public welfare reasons, such as a case of egregious economic adulteration.

B. The Recall Release will:

1. Clearly describe what product the firm is recalling, along with any identifying marks or codes, explain the reason for the recall, and describe the risks involved in consuming the product;
2. Instruct the public on how to properly handle the product if consumers have it in their possession;
3. Provide the name and telephone number of a company contact for consumers and media to call with any questions; and
4. Provide general information about the product’s destination. For example, “Ham and turkey products were distributed to retail stores and institutions in the States of….”

C. When possible, and without slowing the public notification of the recall, FSIS will post an electronic picture of the product label that clearly describes the product to the public on the FSIS website.

D. CPAO is to fax or e-mail a draft copy of the Recall Release to the recalling firm 30 minutes prior to its release. At this time, CPAO is to inform the firm that it may review the Recall Release to verify that the product description, the company contact information, and product distribution information are accurate. CPAO is to inform the firm that if it does not respond to CPAO within 30 minutes of receiving the Recall Release, FSIS will proceed to issue the Recall Release. CPAO is to also inform the firm that if it notifies CPAO of typographical or other inadvertent errors, CPAO is to correct them before issuing the Recall Release.

E. For Class I recalls related to human illness, an Incident Report (IR) will be posted on the FSIS Incident Management System (FIMS) by OPACE. The Recall Release will be attached to the IR. Program areas will update the IR, as appropriate, until the recall is complete.

III. RECALL NOTIFICATION REPORT (RNR)

A. RMTAS coordinates with CPAO to issue an RNR for Class III recalls or for Class I or Class II recalls in situations where FSIS does not issue a Recall Release. Unlike a Recall Release, an RNR is not distributed to media wire services or media outlets in areas that received recalled products. However, RNRs are posted on the FSIS website and are distributed to FSIS e-mail subscribers and the @USDAfoodsafety Twitter Feed. CPAO is to develop the RNR and post it to the FSIS website. RNRs are posted and distributed during normal business hours. If a draft RNR is not completed by close of business, it can be done so the next business day.

B. The RNR will:

1. Clearly describe what product the firm is recalling, along with any identifying marks or codes, and explain the reason for the recall;
2. Provide the name and telephone number of a company contact for consumers and media to call with any questions; and
3. Provide general information about the product’s destination. For example, “Ham and turkey products were distributed to a warehouse in the State of….”

C. When possible, FSIS will post an electronic picture of the product label that clearly describes the product to the public on the FSIS website.

D. CPAO is to fax or e-mail a draft copy of the RNR to the recalling firm 30 minutes before it is posted to the FSIS website. At this time, CPAO is to inform the firm that it may review the RNR to verify that the product description, the company contact information, and the product distribution information are accurate. CPAO is to inform the firm that if it does not respond to CPAO within 30 minutes of receiving the RNR, FSIS will proceed to post the RNR on the FSIS website. CPAO is to inform the firm that if it notifies CPAO of typographical or other inadvertent errors, CPAO is to correct them before posting the RNR.

IV. PUBLIC NOTIFICATION OF RECALLED STATE-INSPECTED OR FOREIGN PRODUCT

A. When a recall is conducted by a retail establishment under a State’s inspection program, FSIS may issue a Press Release announcing the intrastate recall to provide factual information, including identification of the State that is verifying the recall and a description of the affected product. A Press Release provides general public notification through the general news media, either national or local, as appropriate.

B. When FSIS is informed by a foreign government’s food inspection agency or a company under its jurisdiction that the foreign government or the company is recalling product that may be available to United States (U.S.) consumers, FSIS is to issue a Press Release that provides information similar to FSIS Recall Releases or RNRs. For example, FSIS may issue a Press Release that contains information about a Canadian recall if U.S. consumers could have purchased the product in Canada and then brought it into the U.S. FSIS will also conduct effectiveness checks whenever a foreign government or a company under the jurisdiction of the foreign government recalls product available in the U.S., unless, on review, the Agency determines that effectiveness checks are not necessary in a specific situation. FSIS will follow the same procedure in similar cases when the information is received from other foreign government officials that product is adulterated or misbranded.

V. PUBLIC HEALTH ALERTS

A. If FSIS personnel have reason to believe that a meat or poultry product may be associated with human illnesses, but they cannot identify a specific product that FSIS could recommend be recalled, they should report the incident through supervisory channels. FSIS typically becomes aware of these situations from the findings of a foodborne illness investigation conducted by, or reported to, OPHS’s Applied Epidemiology Staff. If appropriate, the situation should be referred to the EMS, as provided in FSIS Directive 5500.2. If the situation is referred to the EMS, the EMS will decide whether FSIS should issue a Public Health Alert.

B. There may be situations in which the Recall Committee determines that a specific product may present a risk to human health, but the Committee cannot recommend a recall. In these circumstances, the RMTAS Director is to notify the OFO AA, and the other Recall Committee members are to notify their AAs. The OFO AA is to convene a meeting of the AAs and advise the Administrator that he/she is convening this meeting. The AAs will decide whether to issue a Public Health Alert or to take no action on the incident. If the AAs cannot resolve the matter, they are to report the situation as a potential significant incident to be resolved by the ECS, as provided in FSIS Directive 5500.2.

C. If FSIS issues a Public Health Alert the alert will, to the extent possible:

1. Identify the firm that produced the product;
2. Clearly describe the product involved, along with any identifying marks or codes;
3. Identify whether the product presents any health risk;
4. Explain the reason the product is adulterated or misbranded and describe the risks involved in consuming the product;
5. Provide an electronic picture of the product label, if one is available, that clearly describes the product to the public;
6. Instruct consumers on how to properly handle the product if, by some remote chance, they have it in their possession; and
7. If available, provide the name and telephone number of a company contact for consumers and media to call with any questions.

VI. RETAIL CONSIGNEE LISTS

A. For every Class I recall, OFO develops a list of retail consignees that may have, or may have had, the recalled products in their possession. OFO gathers the retail consignee information by first contacting all of the recalling establishment’s directly affected consignees. Then, all subsequent consignees to whom the recalling establishment’s direct consignees distributed the recalled product are contacted. OFO asks all consignees if they have the recalled products in their possession. OFO also collects retail consignee information while conducting effectiveness checks. If the recalled product is not distributed to the retail level, OFO does not develop a list of retail consignees.

B. FSIS personnel enter the name, street address, city, and state of each retail consignee into an electronic database. As soon as an initial list of retail locations can be prepared from this information, RMTAS does so. RMTAS then sends the list of retail consignees to the FSIS Web Services Staff for posting on the FSIS website. The initial list is posted within approximately 3 to 10 days of the date of the recall.

C. The FSIS Web Services Staff posts to the list periodic updates from RMTAS as additional retail consignee information becomes available. After the initial posting, updates may be frequent for the first several days, and then less often, as new information becomes less available.

VII. SPECIAL CONSIDERATIONS FOR WHOLESALE LEVEL RECALLS

A. There may be instances in which adulterated or misbranded product that is implicated in a recall is not available to consumers because, although the product is in commerce, it has been distributed only to consignees at the wholesale level (i.e., to warehouses or distribution centers) and the producing company was able to regain control over the product before it could be further distributed to the retail, hotels, restaurants and similar institutions (HRI), or consumer level. In this situation, issuing a Recall Release to inform the public of the recall would not be useful to consumers. FSIS will not issue a Recall Release or conduct effectiveness checks beyond the wholesale level for recalls in which a company is able to regain control over adulterated or misbranded product distributed solely to the wholesale level. Instead, the following public notification and recall verification procedures will apply:

1. Public Notification: If the distribution of adulterated or misbranded product is limited to the wholesale level, and the company is able to account for and regain control over all recalled product, FSIS will issue an RNR instead of a Recall Release. The Agency will follow the procedures for issuing an RNR in Chapter IV, section III, above. The Agency will issue an RNR instead of a Recall Release even if the if the recall is classified as Class I or II.
2. Recall Verification: If the distribution of adulterated or misbranded product is limited to the wholesale level, and the company is able to account for and regain control over all recalled product, FSIS personnel are to verify that the recalling company conducted proper disposition of the product in question. FSIS personnel are to report their findings to RMTAS through supervisory channels. If during their verification checks, FSIS personnel determine that the recalling firm does not have control over all recalled product, and that product may have been distributed to the retail, HRI, or consumer level, they are to notify RMTAS and the RO.

NOTE: Upon the determination that a recall will involve the issuance of an RNR, but not a Recall Release, RMTAS will typically complete the recall during normal business hours.

CHAPTER V – EFFECTIVENESS CHECKS

I. GENERAL

A. The recalling firm is responsible for developing and implementing an effective recall strategy to notify all consignees of the need to remove recalled product from commerce. Consignees are then expected to notify their consignees of the recall. FSIS personnel are to conduct effectiveness checks to verify that the recalling firm has been diligent and successful in notifying and advising the consignees of the need to retrieve and control recalled product and that the consignees have responded accordingly. FSIS will conduct effectiveness checks throughout the distribution chain. Effectiveness checks are risk-based and dependent on the class of the recall (which is based on the hazard and any available epidemiological data), the number of consignees, and other relevant factors. If the recalled product was distributed to the wholesale level only, and the producing company has regained control over the recalled product, FSIS personnel are to verify that the producing establishment has retrieved and conducted proper disposition of the recalled product, as described in Chapter IV section VII of this directive.

B. Depending on the availability of Agency personnel and the type of firm conducting the recall, Enforcement Investigations and Analysis Officers (EIAOs) or CID Investigators are to conduct effectiveness checks. Generally, if the recalling firm is an official establishment, the RO is to coordinate and direct IPP to conduct effectiveness checks. If the recalling firm is an importer of record, the RO is to coordinate and direct IPP to conduct the checks and contact the CID Regional Director to obtain assistance from CID investigators to conduct checks. If at any time during the effectiveness checks FSIS personnel discover that a firm did not contact the consignees promptly with recall instructions or that the consignees are not handling product in the manner requested by the firm, FSIS personnel are to detain any product found in commerce as set out in FSIS Directive 8410.1. FSIS personnel are to notify the RO immediately when the recalled product remains available to the consumer and when the recalling firm has not properly implemented its recall strategy.

II. FIELD RECALL RESPONSIBILITIES UPON NOTICE OF A RECALL

A. The RO is to:

1. Serve as the primary point of contact for the recalling firm;
2. Immediately request that the recalling firm provide information regarding product distribution, including the names, addresses, and phone numbers of its consignees (Attachment 1);
3. Review any notice of recall issued by the firm to its consignees or to the public for accuracy of product information, risk, and clarity (e.g., verify that the firm discloses the reason for the recall and describes the product defect or adulterant) and verify that the recall notice does not contain promotional or company information that obscures the risk of the product. If the recall notice is incomplete or inaccurate, the DO is to immediately call the firm and explain the reasons why the notification or instructions are inadequate and follow up the call with a letter to the firm and a courtesy copy to RMTAS;
4. Inquire how the firm plans to control recovered product; and
5. Inquire how the firm plans to handle product disposition.

B. If the firm’s recall strategy includes destroying product on site, the RO may assign FSIS personnel to witness destruction of the product in accordance with 9 CFR part 329 or part 381, Subpart U. FSIS personnel are to document this on FSIS Form 8400-4, Report of Recall Effectiveness, as product disposition verification.

III. RO RESPONSIBILITIES FOR COORDINATING FSIS PERSONNEL ACTIVITIES IN EFFECTIVENESS AND PRODUCT DISPOSITION VERIFICATION CHECKS

The RO is to:

1. Coordinate effectiveness checks and direct the activities of FSIS personnel;
2. Determine product distribution and request assistance from Assisting Offices (AOs) in districts/regions where product was distributed. The DDMs/RDs are to determine whether additional consignees should be included on the initial distribution list; and
3. Select a sample of consignees based on product distribution information using an appropriate sampling plan (Attachment 1).

IV. FSIS PERSONNEL RESPONSIBILITIES FOR CONDUCTING EFFECTIVENESS CHECKS

A. For a recall to be deemed effective, the number of consignees checked that are found to have the product available to the public must be less than or equal to the critical number in the sampling plan applied to the effectiveness check (Attachment 1). Using the sampling plan selected by the RO, FSIS personnel are to:

1. Contact or visit the consignees to determine whether they were notified of the recall and have removed the recalled product from commerce;
2. Take appropriate action to detain any recalled product found in commerce in accordance with FSIS Directive 8410.1;
3. Determine the amount of recalled product received by consignees. In cases where a consignee cannot document the amount of the recalled product it actually received, FSIS personnel are to explain this on FSIS Form 8400-4, Report of Recall Effectiveness,
4. Verify that the consignees are handling the product in accordance with regulatory requirements and the instructions of the recalling firm by reviewing records and observing or verifying product disposition. If product is to be destroyed at a Federal establishment, in-plant IPP may be asked to witness the destruction of product; and
5. Record the effectiveness checks on FSIS Form 8400-4 and submit the completed forms to the appropriate district or regional office.

B. In cases where a product disposition verification cannot be made upon an initial check, FSIS personnel are to conduct a follow-up check to verify that the product was handled in accordance with the instructions and regulatory requirements, document this on FSIS Form 8400-4 as a follow-up, and

C. In cases where prohibited acts, such as introducing product that the Agency has reason to believe is adulterated into commerce, are noted or suspected, FSIS personnel are to document the occurrence and contact the RO. The RO is to issue, if indicated, a letter to the firm describing the circumstances of the prohibited act and the potential enforcement or criminal action the Agency may pursue. The RO is then to refer the matter to OIEA/CID. If the recall involves imported product, FSIS personnel are to document the occurrence and contact the RO, who is to refer the matter to OIEA/CID.

D. If, when conducting effectiveness checks, FSIS finds recalled product in commerce, the Agency will consider whether the recalling establishment clearly communicated the recall notification to its consignees. FSIS may find that the recalling firm effectively communicated the recall, but that the recalling firm’s consignees failed to ensure that the recalled product was removed from commerce. As necessary, FSIS personnel will follow FSIS Directive 8410.1 and notify the consignee of any prohibited activity.

V. RO RESPONSIBILITIES FOR REVIEWING EFFECTIVENESS CHECKS AND CONFIRMING THE FIRM’S CONTROL AND DISPOSITION OF THE PRODUCT

The RO is to:

1. Compile the recall effectiveness reports from all AOs and State programs to make an overall assessment of recall effectiveness following the criteria and decision guidance in Attachment 1;
2. Analyze the information that is submitted by FSIS personnel on FSIS Form 8400-4 and review any instances in which recalled product was found in commerce. For example, the RO should review the effectiveness check findings to determine whether a pattern or trend exists that may suggest certain consignees were not contacted; and
3. Contact the firm and verify that the firm:

• a. Controlled the recalled product as planned;
• b. Disposed of the product as planned; and
• c. Considers the recall closed.

VI. THE RO DETERMINATION ON THE EFFECTIVENESS OF THE RECALL

A. The RO may determine that the recall was effective based on his or her review of the effectiveness and product disposition verification checks, and that the firm has gained control and made proper disposition of the products. If so, the RO is to send a Final Recall Effectiveness Report (FRER) to the RMTAS Director.

B. The FRER is to include:

1. A summary of the findings of the recall effectiveness and product disposition verification checks; and
2. Any supporting documentation voluntarily provided by the firm, including information about the amount of recalled product recovered.

C. In consultation with RMTAS, the RO may determine that the recall action is ineffective based on his or her review of the effectiveness and product disposition verification checks because of the firm’s failure to control and dispose of the product. The RO is to notify the recalling firm, in writing, and provide a courtesy copy of the notification to the RMTAS Director, explaining why the recall action is deemed to be ineffective. The RO is to ask how the recalling firm intends to address the situation. If the recalling firm is unwilling or unable to correct its recall strategy, the RO is to recommend that the Agency take further action to mitigate the risk to the public. The recommended actions may include public warnings, product detentions and seizures, or other appropriate actions.

D. FSIS personnel conducting effectiveness and disposition checks should continue with all assigned checks even though a recall may appear ineffective. The recall activities should be classified as effective or ineffective after consideration of the number of consignees at which product was available to consumers.

CHAPTER VI – CLOSURE AND POST RECALL ASSESSMENT REPORT

I. CLOSURE

A. RMTAS is responsible for submitting a recommendation for closing a recall to the AA OFO. RMTAS’s recommendation to close the recall should summarize the recall efforts by the firm and the findings of the effectiveness and product disposition checks.

B. Before submitting the recommendation, RMTAS is to review the recall termination report from the RO and, if a recall is associated with a reported illness, ask the Applied Epidemiology Staff, OPHS, whether there are any current illnesses associated with the recalled product.

1. If data indicate that illnesses continue to occur because product remains in commerce, the recall case will remain open. RMTAS may request that the firm expand the recall if evidence indicates that additional products are causing illness.
2. If data indicate that no additional illnesses associated with the recalled product are being reported, and there are no signs that recalled product remains in commerce, RMTAS may proceed to recommend closing the recall.

C. After receiving concurrence from the OFO AA, RMTAS is to notify the recalling firm, in writing, that the recall is closed and notify the FSIS Web master to move the case from the “open” to the “archived” recall case files on the FSIS Website. RMTAS will provide notification to the Emergency Coordination Staff mailbox.

II. POST RECALL ASSESSMENT REPORT

A. On a quarterly basis, or when the OPPD AA determines that it is necessary, OPPD will review the events leading to the recall, as well as FSIS’s response, to assess whether the Agency can improve its policies and recall procedures.

B. OPPD is responsible for coordinating the post-recall assessment meeting. Participants in the meeting may include, but are not limited to, the following Agency personnel:

1. Recall Management and Technical Analysis Staff

2. OFO program personnel:

• a. Executive Associate for Regulatory Operations;
• b. District Manager or DDMs participating in the recall;
• c. Case Specialist from the recalling district; and
• d. IPP.

3. OIEA program personnel:

• a. CID Regional Director;
• b. CID Supervisory Investigator; and
• c. CID Investigator.

4. Other Agency personnel that participated in the recall activities, including personnel from ODIFP, OPPD, OPHS, and OPACE.

C. When conducting the post-recall assessment, the meeting participants should consider pertinent information within and across program areas, such as, but not limited to, the following information:

1. Recall Effectiveness Checks Reports;
2. Food Safety Assessments (FSAs);
3. Enforcement History;
4. Failures of the establishment’s food safety programs;
5. Reports of Consumer Illness; and
6. Any pertinent information collected during the preliminary inquiry, as described in Chapter II.

D. After the close of the post-recall assessment meeting, OPPD will draft a written report. The post recall assessment report should focus on the circumstances that led to the recall and suggest areas where new policy or policy clarification may be needed.

E. The official that drafted the report is to provide a copy to the OPPD AA and to the RMTAS Director. RMTAS is to include the post-assessment report in the official recall file. OPPD will use the information in the report to support new policy development as the need arises.

III. QUESTIONS

Refer questions through supervisory channels.

See full PDF for attachments

• EFFECTIVENESS CHECKS
• Factors That Are Considered by the FSIS Recall Committee in Evaluating the Public Health Significance of an Undeclared Ingredient in a Meat or Poultry Product
• PRODUCT RECALL GUIDELINES FOR FIRMS