A sweeping reform of food safety regulation has occurred.  This is the most significant reform, for decades. The law is enforced by the FDA, and is called Food Safety Modernization Act (FSMA). FDA was given mandatory recall authority immediately, when FSMA was signed into law on January 4, 2011. The new law includes significant enforcement tools sought by consumer advocates.

Here is a list of important new provisions, and how they shall impact on food processors.


The FDA now has legal authority to order the recall of dangerous foods. Prior to the new law, the FDA only had authority to ask, but not demand, that foods be recalled (except infant formula).

The FDA can now order a company to recall a food product if there is “reasonable probability the food is adulterated or misbranded” and that its use “will cause serious adverse health consequences or death to humans or animals.” This is the same criteria for a Class I recall, the most serious type that FDA issues.

For the new law, the FDA first must provide the responsible company with the opportunity to recall the product voluntarily, and cease distribution. If the company fails to do this, based on the FDA’s deadline, the FDA may require an immediate recall. Any company who does not comply with a recall order is liable for penalties and fees.

Usually a company shall issue a “voluntary” recall, as opposed to waiting for an FDA mandatory recall order. Food manufacturers facing a mandatory recall situation should cooperate with the FDA, and focus on consumer confidence in their products.

It is unlikely that the FDA will actually issue numerous recall orders, however their new authority changes the dynamics of these situations. Food manufacturers need to have standard procedures in place now, so that recalls can be initiated promptly and effectively.


FSMA allows the FDA to add  2,000 new inspectors. FSMA states that the FDA shall increase “frequency of inspections” at all food processing plants. High risk identified domestic facilities shall be inspected a minimum of one time by January 4, 2016 and thereafter, at least once every 3 years. All other domestic food processing facilities shall be inspected a minimum of one time prior to January 4, 2018, and thereafter, once every 5 years.

The FDA is also required to increase inspection of food at ports of entry, which may lead more shipments of food and ingredients being detained at the ports.


The Bioterrorism Act of 2002 required food processors to register their facilities with FDA. Under the FSMA, registrations will have to be renewed every 2 years. Registrations shall require sworn assurance that the FDA shall be permitted to inspect their facilities.

Under FSMA, the FDA can suspend the registration of a facility if determined that the facility’s food has a “reasonable probability of causing serious adverse health consequences or death to humans or animals.” If there is a suspension of the facility’s registration, then food from this facility may not be distributed in the U.S.  This would be comparable to the USDA’s decades long authority, to withdraw inspection meat processing facilities, which would shut them down. This new enforcement tool, which FSMA created, enables the FDA to wield much greater authority over food processors.


Under FSMA, every food processing firm must:

1. Evaluate known or reasonably foreseeable hazards associated with their facilities.
2. Perform written analysis of the hazards within their facilities.
3. Identify, and then implement preventive controls for their facilities.

Food processing facilities will be required to monitor the effectiveness of their preventive controls, verify their adequacy, and undertake a periodic re-analysis of their plans. Records shall be maintained for minimum of two years (includes monitoring of preventive controls, and the implementation of corrective action).  If a plant receives repeated warnings regarding this record keeping, the FDA may seek to suspend a facility’s registration.


FSMA allows the FDA to establish pilot projects “in coordination with the food industry to explore methods to rapidly identify recipients of food that may be contaminated”.

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