This fact sheet describes the Food Safety Modernization Act Produce Safety Rule provisions that an alternative or a variance would apply to, who is eligible to develop an alternative or variance, the approval process for both, and the high burden of supporting either an alternative or a variance with credible scientific and technical evidence.
The Food Safety Modernization Act’s Produce Safety Rule (FSMA PSR) provides for alternatives and variances to the regulatory standards in certain circumstances. Alternatives require no preapproval and are limited to certain standards for agricultural water quality testing. Variances enable a state, foreign, or Tribal government authority to petition the Food and Drug Administration (FDA) to approve different standards for nearly all of the FSMA PSR standards. In either case, the FDA requires evidence that the different measure(s) used provides the same level of public health protection as the standards established by the FSMA PSR, which is a high burden to meet.
Suggested Citation
NECAFS & Vt. L. Sch. Ctr. for Agric. & Food Sys., Alternatives and Variance to the Produce Safety Rule (2020), https://elsi.necafs.org/sites/default/files/uploads/fsma_psr_alternatives_variances_factsheet.pdf.
