ATTACHMENT 3 - PRODUCT RECALL GUIDELINES FOR FIRMS

TABLE OF CONTENTS
1. Guiding Principles for Recall Plans
2. Notifying FSIS of Recalls
3. Recall Assessment
4. Recall Termination
5. Recall Follow-up

1. Guiding Principles for Recall Plans

    Introduction

A recall is an effective method of removing product that may be adulterated or misbranded from commerce. Firms, including manufacturers, distributors, or importers of record, take these actions as part of their responsibility to protect the public health and welfare. A recall is voluntary, and the firm takes responsibility for the decision to recall product. FSIS coordinates with the firm to ensure that it has properly identified and removed recalled product from commerce by verifying the effectiveness of recall activities. FSIS also notifies the public about product recalls.

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 the recall strategy or execution of that strategy is ineffective. Based on its findings, FSIS may seek enforcement action against the firm or its consignees.

A recall can occur for many different reasons. Typically, the reason for the recall is not discovered until the product is already in distribution channels. Ways a firm may learn about the problem include through FSIS, the firm?s customers, consumer complaints, or its own review of company or laboratory documents. When an official establishment believes or has reason to believe that adulterated or misbranded product has been shipped into commerce, it must inform its district office (DO) of the type, amount, origin, and destination of the product. Early detection and recognition that a problem may exist is essential to a successful recall action.

A recall can be disruptive to a firm's operation and business; however, there are several steps that can be taken to minimize this disruption. An operator of an inspected establishment should take measures that will ensure rapid and effective response if products that appear to be adulterated have entered commerce.

Official establishments are required to have recall plans that describe the actions they will take to recall adulterated or misbranded products that are in commerce, as provided by 9 CFR 418.3. A recall plan must consist of written procedures that specify how the official establishment will decide whether to conduct a product recall and how it will affect the recall, should it decide that one is necessary.

    Recall Plan

The guidance presented here is intended for all meat and poultry firms that may need to conduct a recall, without regard to plant size or the number of people employed. Some of the recommendations may speak in terms of forming teams of employees to conduct certain activities related to recalls or may seem to imply that sophisticated analyses of potential health hazard situations need to be conducted. However, the key activities discussed below can be performed by one (1) or two (2) individuals in circumstances where there are limited resources. For example, in a small plant operation, the owner or manager of the establishment may be the recall coordinator as well as the contact for the Agency, the firm?s consignees, and the public. The Agency does not expect smaller establishments to hire personnel simply to prepare for recalls. On the contrary, the Agency strongly encourages the management of all firms to prepare themselves, and their regularly employed personnel, for the potential of having to conduct a recall.

FSIS regulations require official establishments that produce meat and poultry products to prepare and maintain written recall plans. The plan must specify how the firm will decide whether to conduct a product recall, and describe, step-by-step, the procedures to follow if a product recall is necessary. In addition, FSIS requires that the recall plan be available for review upon request. The following is a list of factors to consider when formulating an effective recall plan.

        A. Recall Team Members.

One person should be identified as the recall coordinator. The recall coordinator should be authorized to make decisions regarding recall implementation. This person is responsible for managing and coordinating all recall-related activities. The Recall Coordinator will have access to the recall plan and should be knowledgeable about the firm?s operations, including purchasing, processing, quality assurance, distribution, and consumer complaints. The recall coordinator should select people to form a recall team. In establishments with only a few employees, one person can have multiple roles. There is no need to hire additional personnel to execute a recall plan.

For each internal and external member involved in the recall action, contact information (telephone, facsimile numbers, and e-mail addresses, as appropriate) should be identified. In the event that the primary team member is absent, an alternate should be specified. All contact information should be reviewed regularly for accuracy. The roles and responsibilities of every person should be clearly defined.

A firm?s recall plan should include the telephone number of its FSIS DO.

        B. Procedures for Determining Whether a Recall is Necessary.

The recall plan should specify, in detail, actions that the firm will take. All information should be reviewed in determining whether to implement a recall. Factors to consider include:

            1) Has adulterated or misbranded product been produced?

            2) Has adulterated or misbranded product been shipped?

            3) Where has the product been shipped?

            4) Is the product in commerce?

            5) Is the product available to consumers?

Note: If adulterated or misbranded product is in commerce, the firm must notify the applicable FSIS DO within 24 hours. FSIS will then determine the class of the recall based on the potential health risk.

        C. Scope of Recall.

The plan should outline how the establishment will assess the amount and kind of product that is implicated in a problem. It is the firm?s responsibility to define when the problem began, when it was resolved, and what products are affected. As much of this information as possible should be available when the FSIS DO is contacted.

FSIS suggests that the plan specify how the amount of product affected under various scenarios will be determined. Some examples of how to define the scope of product removal actions include: the contamination of a vat of product with a foreign object, the use of an incorrect label, or the use of the same source of raw materials in other lots on other days of production. FSIS will consider such factors as the establishment?s coding of product; the pathogen of concern; processing and packaging operations; equipment; the establishment?s HACCP plan monitoring and verification activities (including microbiological testing); the establishment?s Sanitation SOP records; and whether some or all of the products controlled by the same or substantially similar HACCP plans have been affected. Clean up times do not necessarily define the scope of a recall.

It is to the firm?s benefit to identify correctly the scope of the recall. If the recall needs to be expanded, additional FSIS Recall Releases may be issued, resulting in further media postings. If the firm cannot be certain of the amount of product affected, it is better to be more inclusive in the estimate than to risk an expansion. Good recordkeeping is often the easiest way to maintain accuracy.

        D. Records.

All firms should use a system of product coding sufficient to permit positive product identification and to facilitate effective recalls. Records should be maintained for a period of time that exceeds the shelf life and expected use of the product and at least the length of time specified in FSIS regulations concerning record retention (9 CFR 320; 381.175). Records are vital in tracing product forward to consignees and back to potential suppliers. They include invoices, bills of sale, and shipping documents. Records a firm should have on hand include:

            1) Records for positive identification of products produced (labels, lot numbers, Julian codes, ), and

            2) Distribution information for recalled products. These records may include names/addresses of consignees, method of shipment, date of shipment. It is also useful to note consignees that are schools, hospitals, and distributors.

Firms should maintain production records that would facilitate the traceback of product ingredients. This will help determine causes of adulteration and define the scope of recalls. In the event a recall is necessary because of a positive result on an Agency sample or an outbreak of foodborne illness, verifiable records may be used to demonstrate limiting factors to narrow the scope of a recall. Moreover, the records would be essential in facilitating the traceback of the contamination to its source.

Regarding Escherichia coli O157:H7 and non-O157 STECS, establishments are expected to maintain supplier records for their raw ground beef components and to make these records available to Agency personnel upon request. Then, if a sample of raw ground beef is reported positive, suppliers may be notified that their product may have been the source of contamination. The information FSIS personnel collect includes the name of the supplying establishment, the supplier?s lot number, and production date of the product. This information has proven to be an effective tool for initiating traceback in an effort to find the source of contamination.

If a recall is necessary, a prudent establishment may be able to limit the amount of affected product if it has a detailed record keeping system in place. Carefully maintained production records can serve a vital public health purpose. They provide the establishment and the Agency with a means of pinpointing potential sources of contamination and allow for greater accuracy in deciding which products may be affected. The kinds of records comprising such a system include production or grinding logs showing the times of each grind; the formulation or blend of raw ingredients including amounts and supplier lot identification; the finished product lot and sublot identification; and any microbial data or other information that may indicate microbial independence. The records should indicate and track which lots or sublots of a grinding establishment?s ground beef or other raw materials were used. The records should also track the amounts of each that were used.

Here?s a practical example. If a recall of raw ground beef products is necessary because of contamination with E. coli O157:H7, a key factor in limiting the scope of the recall would be if the establishment (or retail store) is cleaning the grinding equipment between lots. If not, there could be residue contamination from one lot to another. A grinding log indicating lot numbers, supplier, and clean up times, may help limit the scope of the recall. Having these records be clear and easily available will also help the recall process to occur more smoothly.

        E. Recall Communications.

Firms should issue a recall notice to consignees by e-mail, telephone, letter, or fax. Written notices should bear a prominent heading to indicate the importance of the communication. For example, a letter might bear a bold red declaration, ?URGENT FOOD RECALL.? If communication is conducted by phone, it should be followed with a letter, e-mail, or fax. When drafting your recall notice to your direct consignees, consider the following:

            1) Be brief and direct;

            2) Explain the reason for the recall and the associated hazard;

            3) Clearly describe the product and provide sufficient information to enable the accurate and immediate identification of the product including:

                ? product/brand name

                ? product code

                ? package/case size

                ? package/case date code

                ? lot number/expiration date

                ? UPC code;

            4) Provide an explanation of the risk involved if product is used;

            5) Request an official, written response from the consignee firm. Provide a ready means for the recipient of the communication to report to the recalling firm whether it has any of the product. Consider allowing the recipient to place a collect call to the recalling firm;

            6) Provide instructions on what to do with the recalled products. Those instructions can include anything from destruction at the consignee location to return to the official plant; and

            7) Provide plant contact information (for questions).
The recall communication should not contain irrelevant qualifications, promotional materials, or any other statement that may detract from the message.

        F. Public Notification.

Identify if and how the public will be notified of the recall. Recalls are often announced via a press release through national or local news media or via a company website. Include contact information for all potential media outlets, such as television stations, radio stations, and newspapers, and with local, state, and regional coverage areas, as well as the national wire services. The class of a recall and the extent to which the product was distributed in commerce (wholesale, retail, or hotel/restaurant/institutional (HRI)) will determine the distribution of public notification.

NOTE: Regardless of the public notification action taken by the recalling firm, FSIS will generally issue a Recall Release for Class I and Class II recalls, unless the recall involves product that has only been distributed to the wholesale level and the recalling firm is able to regain control over it before it can be further distributed to the retail, HRI, or consumer level. For these wholesale level recalls, and for Class III recalls, FSIS will generally only issue a Recall Notification Report (RNR) that is not distributed to media outlets. The Agency will also post all Recall Releases and RNRs on the FSIS website (www.fsis.usda.gov/OA/recalls/rec_actv.htm).

        G. Effectiveness Checks.

The purpose of effectiveness checks is to verify that all consignees identified by the recalling firm have received notification about the recall and have taken appropriate action. The methods for contacting consignees should be specified and may be accomplished by personal visits, telephone calls, e-mails, letters, facsimile transmissions, or a combination thereof. This is a means of assessing the progress and efficacy of a recall.

The firm should consider the following information:

            ? How much product is implicated in the recall?

            ? How is this product identified to a customer/retailer (e.g., lot markings)?

            ? How many locations did the firm ship the product to, and where are those locations?

            ? How did the firm communicate the product removal action to those who received the product? Did the firm document this contact? Did the firm ask for and receive a written response acknowledging receipt of the information?

            ? What actions were taken with the product and by whom?

            ? If product was destroyed, was destruction witnessed and documented? Were Agency personnel present?

            ? Is there a written record of when the issue was identified, when customers were notified, and when the firm received notification that product was placed on hold or was no longer in a customer?s control?

FSIS will conduct effectiveness checks.

        H. Returned Product Control and Disposition.

The recalling firm must specify how the recalled product will be disposed and how it will be controlled pending disposition. Agency personnel should be notified prior to disposition actions (e.g., destruction or relabeling) of product returned to the firm. (Destroy means to render inedible for humans and animals and to make all labeling unusable for trade.)

        I. Recall Simulations

To evaluate how well its plan will work in the event of an actual recall, the establishment should conduct periodic simulations. A recall simulation or mock recall is used to determine whether the firm?s recall plan is effective at identifying and quickly controlling a given lot of potentially affected product and reconciling the quantities produced, in inventory, and distributed.

A simulated recall should involve the selection of at least one lot of product that has been distributed in commerce. The recall plan should specify a hypothetical reason for recalling the product and it should be followed to establish a strategy for recalling the product. The mock recall should occur without prior notice to personnel involved. Such scenarios may be simple (e.g., one contaminated lot of product) or very complex (e.g., contaminated ingredient used in multiple products and involving rework). A firm may wish to begin with simple scenarios and work up to more complex simulations for their operation. The simulation should proceed at least to the point at which communication occurs with the firm?s primary consignees. Full details of who will be contacted at that point and how contact will be established should be specified. Firms, especially those with products distributed by multi-layer distribution systems, may wish to consider conducting at least one simulation in which t he product to be recalled has been shipped beyond the firm?s initial customer to one or more of the consignee?s customers. Taking the simulation beyond the recalling firm?s organization could reveal potential problems in the retrieval process that might be addressed before an actual recall occurs.

Mock recalls will identify potential problems and allow personnel to become familiar with recall procedures. The results of conducting mock recalls should be documented and reviewed by the recall team to improve the written recall plan. If problems are identified during a recall simulation, the recall plan and procedures should be revised to correct the problems. Mock recalls will make a recall process run smoother, keep the recall team prepared, and provide the recall team with confidence to implement a successful recall action.

        J. Final Actions

The firm?s plan should also include procedures for notifying FSIS once all reasonable efforts to recover and dispose of the recalled products have been made. The firm should provide the relevant information to the Agency to permit official recall termination.

        K. Functional Food Defense Plan

Firms are not required to have food defense plans. However, a voluntary functional food defense plan is an important tool that can enhance the protection of an establishment and its products from vulnerabilities that can cause a potential threat to the food supply. One potential threat is the intentional adulteration of products that the establishment manufactures. In such an event, swift removal of the adulterated materials is essential to protect the public health and welfare. One mechanism for doing this would be a recall. By having an integrated recall-food defense plan, a firm can implement either one, or both, of these measures at a moment?s notice, as needed.

2. Notifying FSIS of Recalls

An official establishment has 24 hours in which to notify FSIS that adulterated or misbranded product is in commerce. If it determines that a recall will be undertaken, it should notify FSIS immediately. When doing so, the official establishment should notify DO personnel in the district where it is located. When other firms, including importers of record, learn or determine that adulterated or misbranded product has entered commerce, FSIS expects those firms to immediately notify RMTAS or other FSIS personnel. The basic information that should be conveyed to FSIS includes, but is not limited to, the following:

    ? Complete and accurate product identity, including product labels (electronic images whenever possible)

    ? The reason for the recall and details about when and how any defect or deficiency was discovered

    ? How much of the product in question was produced and during what period of time

    ? An estimate of how much of the product is in distribution and how long it has been in distribution

    ? Area of geographic distribution of the recalled product by state and by country, if exported

    ? Information regarding distributors and customers who received the product

    ? Copies of any firm correspondence with distributors, brokers, or customers relating to the recall strategy or actions, as well as a copy of any proposed press release

    ? The name, title, and telephone number of the recall coordinator for the firm

The firm may provide this information orally, initially, but FSIS will confirm it. For clarity, it is recommended that the recalled product information listed above be submitted via e-mail. Doing so will prevent errors resulting from hard-to-read handwriting or illegibility because of poor fax transmission. Early on in the recall process, FSIS will generally send a program employee to the establishment to verify distribution records and confirm facts.

3. Recall Assessment

FSIS expects to be kept apprised by the firm on the status of a recall in progress. The firm is expected to regularly report, in a timely manner, the results of its efforts to retrieve the product. The reporting frequency will be agreed upon by the recalling firm and FSIS. FSIS believes that the higher the degree of public health hazard, the more frequently the firm should report. FSIS will conduct its own effectiveness checks, as specified in FSIS Directive 8080.1, Recall of Meat and Poultry Products. In addition, FSIS expects that the firm will notify the Agency when it appears that the recall has been completed.

Unless otherwise specified, the recall status report should contain the following information:

    ? The number of consignees notified of the recall

    ? The dates notifications were made

    ? The method of notification that the firm used for each consignee

    ? The number of consignees responding to the recall communication

    ? The quantity of product each consignee had on hand at the time the communication was received

    ? The number and identity of consignees that did not respond

    ? The quantity of product returned or held by each consignee

    ? An estimated time for completion of the recall

4. Recall Termination

A recall will be terminated when FSIS has:

    ? Completed the recall effectiveness checks;

    ? Determined that the recalling firm has made all reasonable efforts to recall the product; and

    ? Determined that the product is under control or that the recalling firm has disposed of the recovered product.

To effect a timely termination of the recall, the firm should provide all relevant information to the Agency once the firm has determined that it has retrieved all possible product. The firm should create a ?closeout memo? containing a list of customers, the amount of product retrieved, and the actions taken. This memo should be sent to the relevant FSIS personnel. Once the Agency determines that the firm has made all reasonable efforts to recall the product, RMTAS will notify the firm in writing.

5. Recall Follow-up

Once a recall action has been completed, the establishment should notify its customers of this, thank them for their assistance, and provide assurances that the problem has been corrected. The Recall Team should evaluate how the recall action was conducted to determine whether things should have been handled differently, and what, if any, changes should be made to the plan.

DATE

CUSTOMER FIRM NAME & ADDRESS

ATTN: CONTACT PERSON NAME & TITLE

Re: RECALL OF TYPE OF PRODUCT

Dear Sir or Madam:

This letter is to confirm our telephone conversation that Company Name is recalling the following product because Specify Recall Reason:

Describe the product, including name, brand, code, package size and type, establishment number,

We request that you review your inventory records and segregate and hold the above product. If you have shipped any of this product, we request that you contact your customers and ask them to retrieve the product and return it to you. Once you have retrieved all of the product, please contact us. We will arrange to have the product shipped to our facility. Please do not destroy the product. We will credit your account for product returned.

We are undertaking this action in cooperation with the Food Safety and Inspection Service (FSIS) of the U.S. Department of Agriculture. FSIS officials may contact you to confirm that you have received this notice and are cooperating in this action.

Your prompt action will greatly assist Company Name in this action. If you have any questions, please do not hesitate to contact Company Recall Coordinator at Phone Number or e-mail address.

Thank you for your cooperation.

Sincerely,

Company Official Name and Title