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Have you ever wondered what happens when the FDA or FSIS realize that food may potentially
be adulterated, misbranded or cause adverse health effects once it is placed into the
marketplace? This is a great question. Many foods are distributed from the processing
facility to grocery outlets within a matter of a day or two or even hours. The purpose
of this video is to draw your attention to regulatory recall authorities. The specific
learning outcomes are that you will be able to describe the FDIS's recall authority, describe
the recall authority of the FDA prior to the Food Safety Modernization Act of 2011, and
explain how the Food Safety Modernization Act changed FDA's recall authorization. Finally,
you will be able to identify where to find additional information on recalls from the
FDA and FSIS. A recall is a firm's action to remove product from commerce to protect
the public from consuming adulterated or misbranded products. This firm could be a manufacturer,
distributor, or importer. If a firm is regulated by FSIS, it is that firm's decision to recall
their product, since the FSIS cannot mandate this. The Food Safety and Inspection Service
(FSIS), however coordinates with the firm to ensure it has properly identified and removed
recalled product from commerce by verifying the effectiveness of the firm's recall activities.
FSIS also notifies the public about product recalls. When FSIS learns of a potential recall,
it convenes a recall committee, which makes recommendations based on information such
as any pertinent production and distribution data provided by the company. Once the company
initiates a recall, FSIS immediately issues a press release to notify the public, posts
it on its website, and provides information directly to stakeholders—including Congress,
the media, federal, state, and local officials, and constituents. At the conclusion of the
recall, FSIS conducts an effectiveness check to determine whether all appropriate parties
were properly notified and all reasonable efforts were made to retrieve, destroy, or
return the recalled product to the firm. Prior to the Food Safety Modernization Act of 2011,
the FDA functioned just about the same as FSIS in terms of its recall authority. The
FDA generally had to rely upon manufacturers' voluntary recall efforts or obtain a court
order to remove contaminated or misbranded foods from the food supply. In the wake of
a number of large-scale food contamination outbreaks and recalls, on January 4, 2011,
Congress enacted the Food Safety Modernization Act. Section 206 significantly expanding FDA's
enforcement powers over potentially dangerous foods. Under the new law, FDA now has authority
to order the mandatory recall of foods for which there is a "reasonable probability"
that the articles are "adulterated... or misbranded... and the use of or exposure to such articles
will cause serious adverse health consequences or death to humans or animals. In order to
issue such a mandatory recall, FDA must first provide the responsible party with the opportunity
to initiate a voluntary recall. If the party does not discontinue distribution and initiate
the recall, the Secretary of the U.S. Department of Health and Human Services (HHS) is empowered
to order that distribution stop and require a recall. Should the secretary order a recall,
the responsible party has the opportunity to request a hearing within two days to contest
the order and convince FDA that the product should not be recalled. The FDA was first
put to test on this when it was noticed that Salmonella was present on dog food that was
in the marketplace. This was noticed in September of 2012. In this case, the FDA did not flex
its mandatory recall authority because a month later the firm issued a recall. However, in
February of the next year, 2013, the FDA published the noncompliance records that were obtained
from this company. In summary, from time-to-time, foods need to be recalled from the marketplace
as they are potentially adulterated or misbranded. The FSIS may not mandate recalls, however
it is intimately involved in the process as firms issue voluntary recalls. On the other
hand, since the Food Safety Modernization Act of 2011 was passed, the FDA may mandate
recalls. However, part of this process requires that firms are first given the opportunity
to issue a voluntary recall. For more information, consult these references. Section 206 of the
Food Safety Modernization Act, FSIS Directive 8080, and the FDA and FSIS websites.