This proposed rule, if finalized, would, among other things, amend the regulations that specify the method of analysis that the Food and Drug Administration (FDA) uses to determine the concentration of sulfites in foods. The currently specified method of analysis is the Monier-Williams method as refined by FDA. This is known as the optimized Monier-Williams method (OMW Method). This rule proposes to update the incorporation by reference to replace the reference to the Monier-Williams method and the appendix that refines the methodology with an updated reference to the OMW Method and add a recently developed, accurate, and more efficient analytical method of analysis, referred to as a Liquid Chromatography Tandem Mass Spectrometry Method (LC-MS/MS method). The LC-MS/MS method would serve as the primary method used by the FDA to determine sulfite concentrations in foods if this proposed rule becomes finalized. The benefit of this proposed rule would be the cost savings, in the form of time savings, associated with use of the LC-MS/MS method. We estimate that, at the mean, the present value of the benefits of this proposed rule is $1.0 million using a 3 percent discount rate and $0.9 million using a 7 percent discount rate (2017$). The cost of this proposed rule would consist of both one-time validation costs and materials costs associated with use of the LC-MS/MS method. We estimate that, at the mean, the present value of the costs of this proposed rule would be $0.2 million using either a 3 or a 7 percent discount rate (2017$). At the mean, the estimated present value of the net benefits of this proposed rule would be $0.8 million using a 3 percent discount rate and $0.7 million using a 7 percent discount rate (2017$).
Regulatory Impact Analysis
Federal Register: 84 FR 48809. September 17, 2019