FMI argues that FSMA 204 requires revision due to: 1) the costs it imposes, 2) the lack of authority for key components, and 3) its misplaced focus on reactive vs. preventive measures. FMI suggests three changes that would reduce the regulatory burden of the Food Traceability Final Rule:

1. Provide additional flexibility for lot code traceability to eliminate de facto case-level tracking. FMI states that, at minimum, FDA should modify FSMA 204 to allow retail stores and distribution centers to maintain a range of Traceability Lot Codes (TLCs) included in a shipment, rather than the precise lot codes in a particular shipment, while still requiring that distributors maintain and pass forward records tied to only a limited set of TLCs, and that they maintain and pass forward Key Data Elements (KDEs) records tied to each TLC.
2. Exempt intracompany shipments. FMI argues that transactions between locations owned by the same firm are so frequent that maintaining full records for these foods will be costly and unnecessary. FMI also says that requiring traceability records for intracompany shipments is redundant, as internal company recordkeeping systems already trace products through these transactions and these records are already used for traceback purposes.
3. Amend the definition of “Traceability Lot Code source reference.” To alleviate the burden of maintaining and passing forward TLC source references, FMI believes FDA should amend the definition of “TLC source reference” to allow companies to identify the person responsible for assigning the TLC, rather than the location where the TLC was assigned.   

In its comment letter to FDA, FMI also asked the agency to consider withdrawing its proposed rule on front-of-package (FOP) nutrition labeling because FDA “lacks the statutory authority to mandate selection of information to be presented separate from the comprehensive nutrition information” and because it possibly violates “the First Amendment’s protection of commercial speech.”

Additionally, FMI requested that FDA review two rules in its deregulatory efforts: the electronic recordkeeping requirements in 21 Code of Federal Regulations (CFR) Part 11, and the warning statement on high-protein products required by 21 CFR 101.17(d)(3). Finally, FMI asked FDA to prioritize finalizing the proposed rule to allow salt substitutes in standardized foods.

FDA’s and the U.S. Department of Health and Human Service’s (HHS’) “Deregulatory Plan” aims to identify and eliminate outdated or unnecessary regulations as part of a broader federal effort outlined in President Trump’s Unleashing Prosperity Through Deregulation Executive Order.