October 25, 2005
Volume 1 Issue 33

Are Recalls Voluntary?

Who regulates food products?

The Food Safety and Inspection Service (FSIS) within the U.S. Department of Agriculture inspects and regulates meat, poultry and processed egg products produced in federally inspected plants. FSIS is responsible for ensuring that these products are safe, wholesome, and accurately labeled. All other food products are regulated by the Department of Health and Human Services' Food and Drug Administration (FDA).

How are unsafe products discovered?

There are four, primary means by which unsafe or improperly labeled meat and poultry products come to the attention of FSIS:

1. The company that manufactured or distributed the food informs FSIS of the potential hazard
2. Test results received by FSIS as part of its sampling program indicate that the products are adulterated, or, in some situations, misbranded
3. FSIS field inspectors and program investigators, in the course of their routine duties, discover unsafe or improperly labeled foods
4. Epidemiological data submitted by State or local public health departments, or other Federal agencies, such as the Food and Drug Administration (FDA) or the Centers for Disease Control and Prevention (CDC) reveal unsafe, unwholesome or inaccurately labeled food
   
   As soon as FSIS learns that a potentially unsafe or mislabeled meat or poultry product is in commerce, the Agency conducts a preliminary investigation to determine whether there is a need for a recall.

Recall Data Requirements

Although the recall is “voluntary”, the data requirements are not. Please be aware below:

The following information was founded in a “Directive”, which contains instructions of an indefinite duration.  Recall information that FSIS enforces on Meat and Poultry Products can be found in the 8,000 Series Directive, which is called the Compliance Evaluation & Enforcement.  Specifically, the requirements below are an excerpt from Directive 8080.1 titled “Recall of Meat and Poultry Products”, and it was lasted revised on July 29, 2004.  This FSIS Directive provides official communication and instructions to Agency personnel in carrying out FSIS’s functions.  If a recall occurs the following records are required by the FSIS, which is under the USDA jurisdiction:

1. Establishment Number
2. Name and Address
3. Company Recall Coordinator (name, title, telephone)
4. Company Media Contact (name, title, telephone)
5. Company Consumer
6. Contact (name, title, telephone)
7. Reason for recall
8. Brand name
9. Product name
10. Package (Type & Size)
11. Package Code (Use by/Sell by)***
12. Packaging date
13. Case Code***
14. Count/Case
15. Production Date
16. Amount Produced (lbs./cases)
17. Amount held at establishment
18. Amount distributed (lbs/cases)
19. Distribution level (institutional/retail)
20. Distribution area
21. Exported (country)
22. School lunch (yes/no)
23. Department of Defense (yes/no) and Internet or catalog sales (yes/no).

 ***Automation opportunity

The USDA states: 

“A recall is a firm’s voluntary removal of product from trade or consumer channels (e.g., by manufacturers, distributors, or importers) to protect the public from consuming adulterated or misbranded products. A recall may be an alternative to an FSIS detention or seizure of adulterated or misbranded products. Although recalls are voluntary, FSIS verifies all recall activities by official meat and poultry establishments and coordinates any FSIS actions with the recall taken by the firm. For recalls conducted by state-inspected firms or retail establishments, the appropriate state agency verifies the recall in most cases. FSIS will provide the state agencies with any needed assistance and information.”

Robert G. Hibbert, an attorney we have consulted, is a partner in the law firm of McDermott Will & Emery LLP based in the Washington, D.C. office.

His credentials are linked here at: Robert G. Hibbert Biography. 

This is what Bob had to say about the voluntary adjective: "They are voluntary, but you do not want to be the company that does not volunteer from a practical standpoint."

In closing, we still have a concern about our broken case people, so Bob is going to serve as a guest writer for our next newsletter.  He will hopefully clarify: If the case is broken, are the recall requirements still required by the party breaking the case?  In most situations this party is the Distributor. We look forward to Bob’s Newsletter.

    AWARENESS COST NOTHING!   

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