Nov 1, 2008 12:00 PM, By David A Kolman
It is Well understood that the primary purpose of a food recall is to protect the public health from products that present a risk of injury or gross deception, or are defective in some way. However, there is much puzzlement over the food recall procedures.
What's more, there is the widely held belief that the US Food and Drug Administration (FDA) “orders” manufacturers to recall products. This is not the case, although that agency, along with the US Department of Agriculture (USDA), plays a key role in recalls through regulations and guidance indicating when a food recall should be undertaken.
A food recall is a voluntary action by a manufacturer or distributor. But if a company doesn't do a voluntary removal or correction of a marketed food product that the USDA or FDA consider to be in violation of law, legal action can be taken, including seizure of the product and an injunction against the business.
USDA's Lisa Volk presented an explanation of the food recall process during a meeting of the
Global Cold Chain Alliance Assembly of Committees in Washington, DC. She is the director of the recall management staff for the USDA's Food Safety and Inspection Service (FSIS).
FSIS is responsible for ensuring that the nation's commercial supply of meat, poultry, and processed egg products is safe, wholesome, and accurately labeled and packaged. All other food products are regulated by the USDA.
Volk said the FDA defines a recall as a firm's voluntary removal of distributed meat, poultry, or egg products from commerce when there is reason to believe they are adulterated or misbranded under the Egg Products Inspection Act (EPIA), Federal Meat Inspection Act (FMIA), or Poultry Products Inspection Act (PPIA).
A recall is different from a withdrawal, she said. A market withdrawal is a company's removal or correction, by its own volition, of a distributed product that involves a minor infraction that wouldn't warrant legal action by FSIS, poses no health hazard, and doesn't violate FMIA or PPIA.
In addition to a recall and withdrawal, there is a third action — stock recovery. This is a company's removal or correction of product that hasn't been marketed or that hasn't left its direct control. For instance, this would be when a product is located at a company's warehouse, and no portion of the lot has been released for sale.
“A recall is a fast and effective method of removing distributed products, particularly when many lots of product have been widely distributed,” said Volk. Recalls are actions taken by the manufacturers, distributors, and importers to remove a product from the market. The FSIS doesn't have mandatory recall authority.
However, the FSIS may initiate the recall process by informing a firm that adulterated product has been identified in commerce and does present a public health risk. It also has the authority to detain or seize product to protect consumers if a company refuses to conduct a recall.
If a company refuses to recall its product, Volk said the FSIS will issue a product health alert notifying the public of the products being recalled.
Both the FDA and USDA have guidelines for companies to follow when recalling defective products. These guidelines make clear that the agencies expect these companies to take full responsibility for product recalls.
There are three classifications of recalls, said Volk, based on the seriousness of the health hazard associated with the product:
Class I: The most severe recall, it signifies a reasonable probability that consumption of the product will cause serious adverse health consequences or death. By way of example: pathogens in ready-to-eat product, E coli in raw ground beef, and undeclared ingredients such as peanuts and shellfish that cause allergic reactions.
Class II: This is issued when there is the probability that use of a product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote. For example, when a product has very small amounts of undeclared allergens associated with milder human reactions, such as wheat or soy products, or products that may contain extraneous material, such as pieces of plastic.
Class III: The least severe recall means the use of a product isn't likely to cause adverse health consequences. This recall is usually the result of mislabeling, where non-allergenic, GRAS (generally recognized as safe) ingredients are omitted.
When a company announces a meat, poultry, or egg product recall, or the FSIS makes it known publicly that it is recommending a recall, Volk said the company has the responsibility to:
Promptly notify each consignee about recall.
Identify the exact product, lots, codes, sizes, etc.
Explain the reason for the recall and the hazard involved.
Explain how the product is to be disposed of or returned.
“The firm has the responsibility for conducting the recall and for ensuring that its actions are effective in removing product from marketplace,” she said. “FSIS has oversight to make sure this is done.”
The recalling company has to supply the FSIS with its initial distribution list. The agency contacts the first level of distribution to obtain secondary tier of consignees, and so on down the line.
“The process is like a spider web that is followed out until we have a complete consignee list,” said Volk.
It is paramount that companies have good record keeping so that recipients of recalled product can be identified from the customer list, and the distribution of the specific lots of recalled product can be identified, she stressed. So, too, is having records that show whether or not the characterization of product changed, say from bulk packaged meat trim further processed and sold as consumer size packs of ground beef.
Through an effectiveness check process, the FSIS verifies that the recalling company has been diligent and successful in communicating to its consignees of the need to retrieve and control the recalled product. Checks are conducted on a subset or sample of total consignees.
The objective of verification follow-up, Volk said, is to determine that product has undergone proper disposition in accordance with regulations. To verify disposition, inspection personnel may contact companies that dispose of the product, conduct on-site verification, or may request independent verification.
When a company completes a recall, it notifies the FSIS of the amount recovered and disposition measures taken, she said. The FSIS then verifies that reasonable efforts were taken to control and retrieve the product, and then destroyed or suitably reconditioned.
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