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RCI Safety Analysis: Food Safety Modernization Act Review, Part 1

Date Posted: November 29, 2012

This article is reprinted by permission from RCI Safety.

The Food Safety Modernization Act (FSMA) was passed on December 21, 2010, the last full day of the 111th Congress, and signed into law by President Obama on January 4, 2011.

Tribute it to political exhaustion over Obamacare, a plethora of other new regulations or a busy Christmas season, but for the most comprehensive overhaul of the Federal Food, Drug and Cosmetic Act in 75 years, FSMA became law with little fanfare.

FSMA expands the authority of the Food and Drug Administration (FDA) over about 80% of the US food supply.

It does not govern food products currently regulated by the US Department of Agriculture (USDA) such as meat, poultry or egg products.

The forth coming series of articles on FSMA will not argue the merits of the law but simply bring you up-to-date on developments in FSMA in bite-size pieces.

One item of critical importance is the term “food.”

Per Section 201(f) of the Federal Food, Drug and Cosmetic Act:

The term “food” means (1) articles used for food or drink for man or other animals, (2) chewing gum, and (3) articles used for components of any such article.

Therefore, “feed” is “food” and any facility that handles or processes a food or food ingredient will be affected by FSMA in some form.

FSMA mandates a new “Preventative Based Regulatory System” which requires FDA to develop more than 50 new regulations, guidance documents and reports in two years.

FDA will not be able to promulgate this amount of regulation in that time frame and has already missed key deadlines; however, it is ill-advised for the regulated community to stand idly by while the FDA puts the regulatory pieces into place.

Some requirements have already begun.

Biennial registration renewals for food facilities were made available Monday, October 22, 2012.

For more information see “Registration” below or go to:

Some key provisions of FSMA include:

Inspections: FDA will inspect high-risk food processing facilities at least once in the next five (5) years, and once every three (3) years after that. Low-risk facilities will be inspected at least once every seven (7) years. [Effective immediately.] FDA estimates there to be 22,325 high risk and 60,000 low risk facilities in the U.S. Risk rating done per Section 421(a)(1) of FD&CA. FDA will rely on partnerships with private and public (state) inspectors to meet requirements.

Detentions: FDA has the authority to detain a food product if it has “reason to believe” that the product is adulterated or misbranded and may cause harm to humans or animals. [Effective June 2011.]

Suspensions: FDA may now suspend facility operations if it believes there is a reasonable probability that food from the facility could cause harm to humans or animals. [Effective June 2011 or upon FDA’s issuance of regulation to implement].

Recalls: FDA now has the authority to force a recall of any food. [Effective immediately].

Performance Standards: FDA must evaluate relevant health data every two years to determine the most significant foodborne contaminants and then issue guidance documents or regulations setting contaminant-specific performance standards. [Effective date undetermined, implementation requires FDA rulemaking].

Registration: Food companies must register with the FDA biennially, between October 1 and December 31 of each even-numbered year. This will first occur in October-December 2012. [Effective immediately.] The Bioterrorism Act of 2002 required domestic and foreign facilities that manufacture, process, pack, or hold food for human or animal consumption in the U.S. to register with the FDA by December 12, 2003. FSMA requires food facilities to register biennially with submissions containing additional information.

Imports: Food importers must perform risk based foreign supplier verification to ensure imported food is not adulterated. [Effective January 2013.]

We will delve into these key provisions and how they affect business up and down the food chain in more depth in future articles.

For more information, call Joey Barnes at 800-888-9596, ext. 217.

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