CHAPTER V - EFFECTIVENESS CHECKS
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 produci ng 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 availabl e 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.