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.