FSIS Directive 8080.1 Recall of Meat and Poultry Products - Attachment 1 Effectiveness Checks

Attachment 1 - EFFECTIVENESS CHECKS

Effectiveness checks constitute a process by which Food Safety and Inspection Service (FSIS) program personnel 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. Subsequent consignees are then expected to notify their consignees or customers of the recall. FSIS will conduct effectiveness checks throughout the distribution chain.

When conducting effectiveness checks, FSIS will verify that:

        1. The recalling firm has notified all of its consignees about the recall,

        2. Consignees have located, retrieved, and are controlling recalled products, and

        3. Consignees are following the recalling firm?s instructions with regard to the disposition of recalled product, e.g., destruction or return.

NOTE: The Recall Officer (RO) must be notified 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 and 9 CFR part 381, Subpart U.

In some cases, FSIS discovers that the firm is able to account for all adulterated or misbranded product that is in distribution, but is not available to consumers (e.g., in a warehouse or distribution center). If this occurs, and the firm is able to regain control of its product, FSIS personnel will verify that the firm has conducted proper disposition of the product in question. FSIS personnel will report their findings through supervisory channels to the Recall Management and Technical Analysis Staff (RMTAS). The RO will submit a summary memo to RMTAS.

    A. Roles and Responsibilities

        1. Industry - The recalling firm is responsible for conducting the recall and for ensuring that its actions have been effective in removing the product from the marketplace. Recall activities by firms are to start immediately upon deciding to conduct a recall or upon receiving notification of a recall.

        2. FSIS ? FSIS will use effectiveness checks to verify that the recalling firm is conducting the recall effectively, i.e., that the firm is locating, retrieving, and controlling the product and that recalled product does not remain available to consumers. FSIS personnel conduct effectiveness checks by visiting consignees or contacting consignees by phone. As part of its effectiveness checks, FSIS will verify the disposition of the recalled product. If FSIS determines that the recalling firm has not been successful in conducting an effective recall, it will take appropriate actions to ensure the health and welfare of the consumer.

    B. Coordinating Effectiveness Checks

A district official is responsible for coordinating all field recall activities and will serve as the primary point of contact with the recalling firm. A Deputy District Manager (DDM) or other relevant program personnel in the Office of Field Operations (OFO) or a managing official from another appropriate program area (e.g., OIEA Regional Director (RD)) will serve as the Recall Officer (RO) and coordinate the effectiveness checks. If the recall spans across multiple districts or regions, the RO that has the jurisdiction over the recalling firm will coordinate activities across those lines with Assisting Offices (AO).

The RO will:

        1. Determine the number of consignees that will receive effectiveness and on-site product distribution checks by using risk-based tables (Tables 2-5) to develop an appropriate sampling plan.

        2. Direct FSIS personnel and coordinate with AOs located in other districts or regions.

        3. Review the effectiveness check reports and respond by adjusting the sampling plan, as needed, to ensure consignees have removed product from commerce.

        4. Compile all findings and report its overall assessment of the firm?s recall effectiveness to the RMTAS.

Effectiveness Checks:

        1. Are risk-based and dependent on the class of the recall (the hazard) and the number of consignees (the product exposure to consumers). FSIS personnel will verify that the firm is locating, retrieving, and controlling the product and that recalled product does not remain available to consumers. The checks will verify that the consignees are handling the product in accordance with regulatory requirements and the instructions provided by the recalling firm, including those for product destruction or return,

        2. Are performed by on-site verification or by phone. FSIS personnel will contact the consignees of the firm conducting the recall to verify that they have received appropriate notification of the recall and that they are acting on the basis of that notification. Recall effectiveness checks will be conducted based on resource considerations and knowledge of the recalling firm?s and consignee?s practices, and

        3. May disclose that product subject to recall remains available to consumers and in commerce. FSIS inspection program personnel will immediately notify the DDM or RD in their district or region for further instructions and may detain the product.

    C. Effectiveness Checks Sampling Plan

The RO will use a risk-based sampling plan to determine the number of consignees that FSIS personnel will contact during the effectiveness checks. The number of consignees that FSIS will contact will depend on the class of the recall and the number and type of consignees that received the recalled product.

    D. Timeliness of Effectiveness Checks

Upon notice of a recall, the RO will immediately request information and records of the recalling firm and subsequent consignees regarding the distribution of recalled product (per 9 CFR 320.1). The information should contain sufficient details to allow FSIS personnel to understand the distribution patterns and make contacts without further delay.

The RO will be able to develop the recall effectiveness check sampling plan in a more efficient manner if the recalling firm?s distribution records, as well as those of any subsequent consignees, are in an electronic format. Therefore, when the RO requests consignee records from the recalling firm, or the AO requests subsequent consignee records, they should ask whether the firm maintains electronic records. If the firm does, then the RO/AO should request that the firm provide its distribution information in an electronic format.

The Federal Meat Inspection Act (FMIA), Poultry Products Inspection Act (PPIA), and their implementing regulations require that companies give FSIS personnel access to their places of business and the opportunity to examine and make copies of their records (21 U.S.C. 642(a) and 460(b); 9 CFR 320.1 and 381.178). If a recalling firm maintains electronic records, FSIS personnel are authorized to gain access to and make copies of such records.

The RO will attempt to obtain the complete distribution information regarding the recalled product within the timeframe recommended in Table 1. Each district/region should consider recall verification activities for public health-related recalls to be a high priority. Table 1 describes the recommended timeframes for the initiation of verification activities and for the substantial completion of these activities. When situations arise that may delay the verification or reporting activities, or affect the timeframes presented in this table, it is the responsibility of each AO to notify the RO.
During the recall, the RO also has an oversight function of assessing whether the recalling firm has in fact initiated and is performing the recall activities necessary for there to be a successful recall.

Table 1. Recommended timeframes for initiating and reporting verification activities within FSIS
Recall classification Following the initiation of a recall, FSIS verification activities should begin as soon as possible within a period of: Following their initiation, FSIS verification activities should be substantially completed within a period of:
Class I 3 days* 10 days
Class II 5 days 12 days
Class III 10 days 17 days
* Working days: Working days may include Saturday and Sunday, depending upon the risk associated with a recalled product.

    E. Determining the Total Number of Consignees and Compiling the Master Consignee List.

        1. The RO will, in discussion with the recalling firm, and, if some consignees are distributors, in consultation with AOs, determine the best estimate of the number of consignees and begin to develop a master list of consignees, i.e., entities that received the recalled product or that will be notified of the recall.

Example: If the recalling firm has 50 retailers and 5 distributors, and the 5 distributors in turn have 400, 200, 300, 100 and 150 retailers, the best estimate of the number of consignees is 1,200. The effectiveness checks are done based on 1,200 consignees.

Note: Consignees that are identified after FSIS has started conducting effectiveness checks are to be added to the end of the master consignee list and included in the sampling plan. If necessary, the sampling plan is to be updated to ensure that consignees that are added to the master list receive an appropriate number of effectiveness checks. Additional consignees added to the master list will also need to be randomized as provided in section E.3. below.

The best estimate is not the ?customer? list of a recalling firm. It is rather the estimate of consignees (e.g., retailers, restaurants and food service institutions), which would have received the recalled product. In order to expedite the verification process, the recalling firm should be able to provide its best estimate to FSIS by phone or e-mail before sending more detailed distribution information. However, care must be taken that the estimate does not significantly differ from the actual distribution information.

Where there is concern that the distribution information is not accurate or complete (i.e., a generic list of chain stores is missing a few known stores), the RO will prepare a list identifying other potential consignees or distributors who may carry the recalled products but were not included in the distribution information given by the firm.

        2. Eliminating duplicate consignee listings: After the RO has started the master consignee list and has obtained more detailed distribution information about the recalled product, he or she is to examine the consignee list for duplicate entries of the same consignee and remove any consignees that are listed more than once.

? If the consignee list is provided in an electronic spreadsheet format, the RO can sort the list by consignee or address to easily identify and remove any duplicate consignee entries.

? If there are multiple consignee lists, the RO can consolidate the lists into one electronic format. The RO can then sort the electronic consolidated list by consignee or address and remove any duplicate entries.

? If the consignee list is only available as hard copies, the RO can either: 1) consolidate the hard copies into an electronic spreadsheet format and eliminate the duplicates as described above or 2) approximate the procedure described above using the hard copies, e.g., examine the hard copies and cross out duplicate or multiple consignee listings.

        3. Randomize the consignee list: After eliminating duplicate listings of the same consignee, the RO is to randomize the consignee list. Randomization can be accomplished through either of the following methods.

            a. If the master consignee list is in an electronic format, the RO can use the electronic spreadsheet program to assign a random number to each consignee on the list and then sort the consignees by random number. After randomizing the consignee list, the RO should follow the instructions in Section I. 3 of this attachment when preparing the sampling plan, or

            b. If the master consignee list cannot be sorted electronically, the RO can generate a list of random numbers as provided in Section I. 4 of this attachment and use these numbers to randomly select consignees for effectiveness checks. If this method is used, the RO should follow the instructions in Section I. 4 of this attachment when preparing the effectiveness checks sampling plan.

States with a Memorandum of Understanding (MOU). Under 9 CFR 390.9, FSIS may have an MOU with one or more States. The specifics of each MOU will vary. In general, when States and FSIS have MOUs to conduct their own effectiveness checks, the Agencies will collaborate in sharing resources and information whenever possible. FSIS will work with States to ensure that effectiveness checks are conducted in a manner consistent with FSIS procedures.

NOTE: Recall procedures for meat and poultry products produced in an establishment operating under the Cooperative Interstate Shipment program are addressed in Chapter IV, Section I, Paragraph D of Directive 5740.1, Cooperative Interstate Shipment Program.

    F. Determining the Total Number of Effectiveness Checks to Conduct

After the RO has removed duplicate consignee entries from the master consignee list and has determined the total number of consignees, the RO will determine the total number of effectiveness checks that will be performed by on-site verification and by telephone. These numbers are derived from values given in the sampling tables in this document. If there is sufficient information, the RO may decide to group effectiveness checks by special consignee categories (e.g., schools, day care centers, hospital cafeterias, or retirement homes). If the RO decides to group effectiveness checks by special categories, he or she is to determine the number of effectiveness checks based on each consignee category as provided in Section G of this attachment.

Table 2 is used to determine the number of checks for all Class I recalls when there has been an illness or outbreak, or school lunch implications (see Section G: Special Considerations for Sorting the Consignees List).

Table 2. Effectiveness checks to conduct and critical limits for all Class I recalls involving an illness or outbreak, or school lunch implications.
Number of Consignees Number of Effectiveness Checks to Make Recall Considered Ineffective if the Number of Consignees at which Product was Available to Consumers Exceeds:
1 to 200 100% of consignees 0
201 to 10,000 200 0
10,001 to 35,000 800 1
35,001 to 500,000 800 1
500,001 and over 1,250 2
        1. Table 3 is used to determine the number of checks for Class I recalls when there are no illnesses, outbreaks, or school lunch implications.

Table 3. Effectiveness checks to conduct and critical limits for Class I recalls when there are no illnesses, outbreaks, or school lunch implications.
Number of Consignees Number of Effectiveness Checks to Make Recall Considered Ineffective if the Number of Consignees at which Product was Available to Consumers Exceeds:
1 to 20 100% of consignees 0
21 to 150 20 0
151 to 1,200 80 1
1,201 to 2,300 125 2
2,301 to 10,000 200 3
10,001 to 35,000 315 5
35,001 to 150,000 500 8
150,001 to 500,000 800 12
500,001 and over 1250 18
        2. Table 4 is used for Class II recalls.

Table 4. Effectiveness checks to conduct and critical limits for Class II recalls.
Number of Consignees Number of Effectiveness Checks to Make Recall Considered Ineffective If the Number of Consignees at which Product was Available to Consumers Exceeds:
1 to 5 100% of consignees 0
6 to 25 5 0
26 to 150 13 0
151 to 280 15 0
281 to 500 32 1
501 to 1,200 37 1
1,201 to 2,300 42 1
2,301 to 10,000 64 2
10,001 and over 91 3
        3. Table 5 is used for Class III recalls.

Table 5. Effectiveness checks to conduct and critical limits for Class III recalls.
Number of Consignees Number of Effectiveness Checks to Make Recall Considered Ineffective if the Number of Consignees at which Product was Available to Consumers Exceeds:
1 to 8 100% of consignees 0
9 to 50 5 0
51 to 90 7 0
91 to 150 10 0
151 to 280 20 1
281 to 500 25 1
501 to 1,200 30 1
1,201 and over 42 2
Effectiveness and disposition checks for Class III recalls will be performed by telephone, unless the RO determines that on-site verification is necessary.

    G. Schools and other Special Consignee Categories

If information is available, the RO may group effectiveness checks by identified special categories (e.g., schools, day care centers, hospital cafeterias, and retirement homes), to mitigate risk to populations that may be more susceptible to foodborne illness. If the RO decides to separate groups by special categories, then each group of consignees should be considered separately. Use the tables to determine the number of effectiveness checks to be conducted for each special group. This will have the effect of increasing the number of effectiveness checks to be conducted at these facilities.

During Class II and Class III recalls, schools may also be grouped into a special category of consignees for conducting effectiveness checks. FSIS typically does not conduct effectiveness checks on schools that participate in the School Lunch Program or other assistance program administered by USDA?s Food and Nutrition Service (FNS) and that receive reimbursement for the cost of the recalled product by FNS. However, FSIS may determine that effectiveness checks or other actions are necessary at such schools, on a case-by-case basis. During Class III recalls, all checks may be conducted by telephone.

In special limited circumstances, to protect public health, FSIS may decide to conduct a greater number of effectiveness checks than the number provided in the tables. For example, FSIS may increase the number of effectiveness checks if the recall involves a product that has been implicated in human illnesses and the Agency continues to receive reports of new illnesses after the issuance of the Recall Release.

    H. Determining the Number of Disposition Verification Checks

The purpose of disposition verification checks is to verify the disposition of the recalled product. A subset of the total number of effectiveness checks for Class I and Class II recalls will be selected for on-site visits to verify that consignees have located, retrieved, and controlled recalled product according to the recall notification. Class III recalls are discussed below. All firms that received the recalled products are expected to remove that product from commerce.

        1. For Class I recalls involving illness, outbreaks, or school lunch implications, the RO will consult with RMTAS on the number of on-site verifications.

        2. For Class I recalls that do not involve illnesses, outbreaks, or school lunch implications and Class II recalls, the same tables used to determine the total number of recall effectiveness checks will be used to determine the number of effectiveness checks that will be conducted on-site.

        3. For Class III recalls, which by definition have no public health implications, effectiveness checks will generally be conducted by telephone. However, if determined to be necessary, they may be conducted on-site.
FSIS personnel are to document recall effectiveness checks findings on FSIS Form 8400-4, Report of Recall Effectiveness. Information collected on-site or by telephone should be recorded on FSIS form 8400-4. This form should also be used to document findings by FSIS personnel conducting disposition verification checks.

Example: If the number of consignees is estimated to be 600 for a Class II recall, Table 4 shows the total number of effectiveness checks to conduct is 37. Using the same table, this time inserting 37, 13 of those 37 effectiveness checks will be conducted onsite. This is shown in the figure below.

Table 4. Effectiveness checks to conduct and critical limits for Class II recalls.
Number of Consignees Number of Effectiveness Checks to Make Recall Considered Ineffective if the Number of Consignees at which Product was Available to Consumers Exceeds:
1 to 5 100% 0
6 to 25 5 0
26 to 150 (Total number of effectiveness checks falls here) 13 (Number of on-site disposition verifications) 1
151 to 280 15 2
281 to 500 32 1
501 to 1200 (600 consignees falls here) 37 (Total number of effectiveness checks) 5
1201 to 2300 42 8
2301 to 10,000 64 2
10,001 to and over 91 3
    I. Preparing the Effectiveness Checks Sampling Plan

The RO prepares an effectiveness checks sampling plan in consultation with AOs.

        1. Using the appropriate table, determine the sampling rate.

For a Class II recall and 600 consignees, the appropriate table is Table 4 and the number of effectiveness checks to conduct is 37.

        2. If the RO decides to group effectiveness checks into special categories (e.g., schools, day care centers, hospital cafeterias, and retirement homes), then each group of consignees is considered separately. Use the tables to determine the number of effectiveness checks to be conducted for each group.

In the example above, if the 600 consignees include three (3) special consignee groups of 200 consignees each, then Table 4 shows that each group would have 15 effectiveness checks conducted. Thus, the total sampling number of effectiveness checks for all three (3) groups would be 45.

Grouping consignees into separate categories should always result in an increase in the number of effectiveness checks to be conducted.

        3. If the master consignee list has been randomized as provided in Section E.3.a., determine a sampling interval by dividing the total number of actual or estimated consignees by the number of effectiveness checks to be performed.

In this example, divide 600 by the minimum sample size (example 37). The sampling interval would be 16 (600/37 = 16.2 rounded to the lower whole number).

            a. Randomly select a number from 1 to the sampling interval to determine the starting point.

For this example, select number 3.

            b. Start at the top of the master consignee list and count down until reaching the consignee located at the randomly selected starting point. This will be the first consignee selected for an effectiveness check. Then select subsequent consignees from the list according to the predetermined sampling interval.

In the example above, the sampling interval is 16, and the starting point is 3. Beginning at the 3rd consignee, add the sampling interval (16). Select the 19th, 35th, 51th ... and so on until enough consignees are identified for the effectiveness checks.

        4. If the master consignee list has not been randomized as provided in Section E.3.a., use random numbers to select consignees from the master list for effectiveness checks. This can be done by using the random number generator that has been loaded on all FSIS computers.

            a. Open the random number generator (Start?³FSIS Applications?³Other Tools?³Random Number Generator).

            b. Generate a list of random numbers. Use one as the lower bound number, use the total number of consignees for the upper bound number, and use the number of effectiveness checks needed as the number of random numbers to be generated. Do not allow the program to generate duplicate numbers by checking the ?no duplicates? box.

In the example above, there are 600 consignees and the tables provide for 37 effectiveness checks. In the random number generator, enter 1 as the lower bound number, 600 as the upper bound number, and 37 for the random numbers that need to be generated. The random number generator will create a list of 37 random numbers, e.g., 5, 8, 14, 22, 44, 47, 51...

            c. After generating the random numbers, select consignees for effectiveness checks. Start at the top of the list and count down to the consignee that corresponds with each random number. Select these consignees for effectiveness checks.

In the example above, 37 random numbers will be generated, e.g., 5, 8, 14, 22, 44, 47, 51, Counting down from the top of the consignee list, select the 5th, 8th, 14th, 22nd, 44th, 47th, 51st, , consignee for effectiveness checks.

        5. Provide information on the consignees selected for effectiveness checks to the FSIS personnel that will be conducting the checks. If the recalled product was distributed to consignees in more than one district or region, distribute the sampling plan to the appropriate AOs. The AOs will assign FSIS personnel to perform the effectiveness checks in their district or region.

The information that the RO provides to the FSIS personnel conducting the effectiveness checks should include the consignees selected for effectiveness checks, the consignees that will need product disposition verification checks, the recommended timeframes for completion, the related recall numbers, and any other details that may help conduct the verification activities more effectively.

    J. FSIS Personnel Responsibilities for Conducting Effectiveness Checks

Based on Agency resources and the FSIS field office responsible for coordinating the effectiveness checks, the following FSIS personnel could be responsible for conducting effectiveness checks: Enforcement, Investigations, and Analysis Officers (EIAOs), Public Health Veterinarians (PHVs) trained in EIAO methodology or OIEA/CID.

FSIS personnel will conduct an appropriate number of effectiveness checks to verify that the firm is locating, retrieving, and controlling the product, and that product that is recalled does not remain available to consumers. The checks will verify that the firm is handling the product in accordance with regulatory requirements and instructions provided by the recalling firm, including those for product destruction or return.

FSIS personnel also will assist the RO in identifying consignees, selecting consignees in accordance with the sampling plan, conducting effectiveness checks, and taking appropriate corrective actions.

If FSIS personnel are unable to perform an effectiveness check (e.g., a consignee in the sampling plan did not receive the recalled product or is no longer in business), they are to contact the RO so a replacement effectiveness check can be selected and assigned. The RO will use the master distribution list to identify the substitute consignee by selecting the next consignee on the master list. After making this substitution, the RO will assign this effectiveness check to the applicable AO and FSIS personnel will conduct effectiveness checks on the remaining consignees as if there had been no substitution.

Example: Using the example discussed in I.3.b., if the 19th consignee was designated for an effectiveness check but the consignee was no longer in business, the RO would select the 20th consignee on the master list as the substitute effectiveness check. The RO would then assign the substitute effectiveness check to the applicable district/region. In the instance where the last consignee in the sampling frame is ineligible for an effectiveness check, substitute the consignee immediately preceding the ineligible consignee.

If the consignee selected for substitution is also ineligible for an effectiveness check, the RO is to select another substitute consignee. The second substitution can either be the next consignee on the list or a consignee that the RO believes is likely to have received the recalled product (biased substitution). The RO should make a reasonable attempt to find a substitute consignee until the effectiveness check can be completed.

If both the 19th and the 20th consignees in the example above were out of business, the RO would select the next effectiveness check using either the 21st consignee on the master list or another consignee that the RO believes is likely to have received the recalled products (a biased substitution).

If FSIS personnel are having difficulty locating a substitute consignee that received the recalled product, the RO is to contact RMTAS.

Note: There can be no substitutions if the sampling plan provides for effectiveness checks on all consignees.

When conducting effectiveness checks, FSIS personnel are to:

        1. Ensure that copies of the Recall Release or Recall Notification Report (RNR) and labels of the recalled product are on hand when conducting verification activities. These documents can then be referenced or left with consignees, if needed.

        2. Conduct checks to determine whether consignees have received notification of the recall action from the recalling firm or other consignees and have taken the prescribed action regarding product, such as returning it to the recalling firm or identifying and holding it for pick-up. If available, FSIS personnel are to obtain from the consignee documentation regarding recall notification (e.g., copy of e-mail notification) and documentation of product disposition (e.g., reclamation documentation from distributor or electronic notification from consignee to corporate office identifying product disposition).

        3. Conduct checks by on-site observation, records review, or telephone, based on resources and knowledge of the recalling firm?s and consignees? practices.

        4. Determine whether any recalled product remains available to consumers, e.g., by checking store shelves, storage, or freezers during on-site visits.

        5. Conduct checks to determine whether the recalling firm or consignees have disposed of the recalled product according to the prescribed action.

        6. Request that the consignee immediately follow the instructions if the recalled product is being held for sale or used against directions provided in the recalling firm?s notification of the recall action.

        7. In cases where consignees were not notified of the recall, ensure that the appropriate associated firms, including distributor, chain store head office, or individual store, are notified and take action if necessary to detain product that is recalled.

        8. Continue with all the assigned checks.

Submit verification results, including findings of product in commerce, and the names of consignees that were not notified by the recalling firm to the RO via the fastest possible means (e-mail, fax, telephone) as soon as possible.

    K. ?Findings of Product in Commerce? is defined as those occurrences where recalled product remains available to consumers.

        1. When the DDM/RD is notified by personnel in his or her district/region of findings of recalled product in commerce, he or she will immediately notify the RO.

        2. The RO is to determine whether the findings follow a pattern or trend. During the evaluation, it is important to distinguish between isolated reasons (i.e., the product was removed in a store but was re-shelved by mistake) and widespread systemic reasons (i.e., breakdown in the notification of consignees or delay caused by the schedule of sales personnel). This is important to do, even if the recall itself is effective, because there may be subgroups of consignees that have recalled product that is available to consumers. As deemed appropriate and necessary, the RO will notify the Director of the Compliance and Investigations Division (CID), OIEA.

    L. Special Circumstances -- Determining the Need to Consult a Statistician

Although rare, there may be instances in which FSIS personnel may need statistical guidance when performing recall effectiveness checks. For example, FSIS personnel may not be able to contact consignees in the sampling plan because the consignees are mobile (e.g., the product was distributed to cruise ship or for door-to-door sales) or the recalling firm sold recalled products directly to consumers.

In these circumstances, FSIS personnel are to inform RMTAS. RMTAS will contact the Office of Data Integration and Food Protection (ODIFP) statistician assigned to assist with recalls and will refer the statistician to the appropriate RO. The ODIFP statistician will work directly with the RO to provide any needed statistical guidance.

    M. RO Determines the Effectiveness of the Recall

        1. The objectives of verification activities are to evaluate:

            a. The overall effectiveness of the recall -

                (1) For a recall to be deemed effective, the number of consignees found to have recalled product in commerce must be equal to, or less than, the critical number in the sampling plan as shown in the corresponding tables 2,3,4 and 5.

                (2) The RO should review the results of the recalling firm?s effectiveness checks. This activity is most effective when conducted on-site and is likely to include a review of documentation, such as confirmed recall notices, receipts of returned product, telephone call reports, and e-mail confirmations.

            b. The recalling firm?s process ? When a firm?s recalling strategy is not adequate to remove recalled product from commerce, FSIS will take the appropriate measures, including detaining product, to protect consumers.

            c. The actions taken by the consignees when advised of the recall ? When consignees (e.g., retailers, restaurants, food service institutions, and wholesalers) along the distribution chain were properly advised of the recall but have not taken the requested action to remove product, FSIS may detain product or take other appropriate measures to ensure the product is not in commerce.

        2. Examples of Effective and Ineffective Recalls:

            a. The RO makes the determination of whether a recall is effective or ineffective in consultation with RMTAS. FSIS personnel conducting checks would need to continue with all the assigned checks even though a recall may appear ineffective. Depending upon the actual sampling calculations, the final sample count may differ (generally be higher) from the count listed in the tables. Therefore, caution should be used in the interpretation of the critical numbers. The recall activities should be classified as effective or ineffective after considering the number of consignees at which product was available to consumers.

            b. Using the previous example of 600 consignees on a list for a Class II recall, with verification done at 80 randomly-selected consignees, Table 4 shows the critical number to be five (5). There can be no more than five (5) consignees with recalled product available to consumers.

Example I: All consignees checked have received the Notice of Recall from the recalling firm and have removed the product from sale. The recall is deemed effective.

Example II: Nine (9) consignees checked have not received the Notice of Recall from the recalling firm, or its subsequent consignees, but were notified of the recall through the media. Six (6) of the nine (9) consignees have removed the product from sale. The remaining three (3) consignees have identified and segregated the product awaiting shipment to the recalling firm. No product is available to consumers. The recall is deemed effective because no product is available at the nine (9) consignees and the number of consignees at which product was available to consumers is not exceeded.

Example III: FSIS personnel find that four (4) consignees have not received the Notice of Recall and are still offering the product for sale. Five (5) more consignees received the notice but have not taken the requested product action. The recall is deemed ineffective because the product remains available to consumers at a total of nine (9) consignees, exceeding the critical number of five (5) consignees.

        3. Whenever recalled product is found in commerce during an on-site verification check at a consignee (or sub-consignee), FSIS personnel will detain any of the products on hand in accordance with FSIS Directive 8410.1.

        4. FSIS personnel will ascertain whether the business received a recall notification and instructions from the recalling firm or one of its consignees.

        5. FSIS personnel will notify the RO of their findings at the business regarding the detained product and whether or not adequate recall instructions were received.

            a. If a recall notification and product instructions were not received, the RO will proceed as discussed below in Section 4.

            b. If a recall notification was received, but the consignees did not respond appropriately to the instructions of the recalling firm, the consignee may have committed an act prohibited by the FMIA or PPIA. In such cases, the RO will issue, when the facts indicate, a letter to the firm describing the circumstances of the prohibited act and the potential enforcement or criminal actions that the Agency may pursue. If the recall affects multiple districts/regions, the district/region with jurisdiction over the consignee that may have committed the prohibited activity will issue the letter. When applicable and deemed necessary, the district that issued the letter will also refer the matter to the OIEA/CID.

        6. When applicable and deemed necessary, the RO will also notify any State or local food or health authorities with jurisdiction over the business involved for their appropriate follow-up action in conjunction with OIEA.

        7. Responding to an ineffective recall -

            a. If, at any time during the verification of the recall, the RO determines that the recall effort is ineffective, the RO will notify the RMTAS Director.

            b. The RO will write a letter to the recalling firm detailing the reasons why the recall has been found to be ineffective. The RO should ask whether the recalling firm intends to act to address the situation.

            c. If, after having been formally notified by FSIS of the ineffectiveness of their recall, the recalling firm is unwilling or unable to extend or modify its recall strategy, FSIS will act to mitigate the risk to the public, including the issuance of public warnings, product seizures, or other appropriate legal or compliance actions in accordance with the FMIA and PPIA.

    N. Verification Result Summaries

        1. The RO will prepare a summary of recall activities and provide it to RMTAS. The summary should:

            a. State the total number of assigned effectiveness checks and disposition verification checks performed and the numbers conducted both on-site and by telephone, as well as the number of invalid consignee locations for which substitutions were requested.

            b. Assign an overall effectiveness rating to the recalling firm?s recall activities (effective or ineffective).

            c. Determine how many consignees may still have product on sale.

            d. Identify reasons for continued sale.

            e. Identify other deficiencies in the firm?s recall process (if applicable).

            f. Summarize actions taken by FSIS in the case.

        2. The summary should include a description of the corrective actions taken to address each identified deficiency (i.e., the product was removed and segregated in the shipping area and re-notification was issued for all convenience stores, including names of affected distributors, as applicable).

        3. The RO will send the memo to the RMTAS Director.