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Congress Urged To Revisit FSMA Due To Its Prescriptive Nature; Costs Outweigh Benefits
FDA Using FSMA As Excuse To Strengthen, Expand Its Regulatory Grip On Industry
The US Food and Drug Administration (FDA) is “unable to demonstrate” that the benefits of four regulations required under the Food Safety Modernization Act (FSMA) outweigh their costs, according to a recent study for the Mercatus Center at George Mason University.
Under the FSMA, FDA has proposed 10 regulations, according to “Regulations Implementing the Food Safety Modernization Act,” by Richard A. Williams. The study was released before FDA released its final preventive controls rules for human food and animal feed.
“Congress should have requested that the studies be completed before passing the legislation...”
“Congress should revisit the
FSMA because of its prescriptive nature.” Congress has given itself the power to review major rules under the Congressional Review Act of 1996, and “all the FSMA major rules represent an ideal place for Congress to intervene.”
Before passage of the FSMA, Congress did not have information on the likely costs or the benefits of all the regulations, the study pointed out. The FSMA requires FDA to perform a number of studies intended to inform the design of proposed regulations, but the law requires only that FDA complete these studies by the time it finalizes the regulations.
“Congress should have requested that the studies be completed before passing the legislation that forced the FDA to issue new regulations,” the study said.
Under the FSMA, Congress mandated that FDA promulgate a “sizable number of costly regulations,” the study noted. As of mid-August, the agency had promulgated 10 regulations (proposed or final rules).
FDA’s own preliminary estimates predict that the regulations required by the FSMA, as written by FDA, would cost well over $2 billion on an annualized basis. According to FDA’s estimates, costs in the first year of implementation will be well over $3 billion.
Those estimates may be low for a number of reasons, the study said. For example, FDA has foreshadowed that it might add a number of additional regulatory provisions to the final rules (the costs of which were not included in the estimates of the proposed rules). Also, FDA’s estimates might not include many of the costs of following the regulations that the food industry has identified in its comments on the proposed rules.
The study addresses four of the “most burdensome” regulations drafted by FDA, including proposed rules for preventive controls for human food and for animal food, intentional adulteration, and produce safety.
Despite the “high cost” of complying with the FSMA regulations, FDA “has been unable to show that significant systematic public health risks warrant some of its regulations or, in other cases, indicate.. Send me more information.