The ST Rule does not require that trailers hauling food products be sealed during transit. We stated in the final rule that routine security measures, such as the use of truck seals, are beyond the scope of the rule. We also addressed what measures entities subject to the rule should take if they observe evidence of tampering during transportation operations (see comment/response 46). Further, if a party subject to the ST rule becomes aware of conditions that may render the food unsafe during transportation, the rule requires that the food not be sold or otherwise distributed unless a determination is made by a qualified individual that the condition did not render the food unsafe.
Additionally, the Mitigation Strategies To Protect Food Against Intentional Adulteration rule (21 CFR Part 121; 81 Fed. Reg. 34166) (IA Rule) does not include requirements for carriers. The IA Rule applies to the owner, operator or agent in charge of a domestic or foreign food facility that manufactures/processes, packs, or holds food for consumption in the United States and is required to register under section 415 of the Federal Food, Drug, and Cosmetic Act (21 USC 350d) unless subject to an exemption (see 21 CFR 121.5 for exemptions). The IA Rule requires covered facilities to prepare, or have prepared, and implement a written food defense plan that includes a (1) written vulnerability assessment, including required explanations, to identify significant vulnerabilities and actionable process steps; (2) written mitigation strategies including required explanations; (3) written procedures for the food defense monitoring of the implementation of the mitigation strategies; (4) written procedures for food defense corrective actions; and (5) written procedures for food defense verification (21 CFR 121.126). If a facility identifies an actionable process step associated with transportation, the facility must identify and implement mitigation strategies to significantly minimize or prevent the significant vulnerability associated with that actionable process step (21 CFR 121.135). Based on our vulnerability assessments, we determined that the most practical mitigation strategies to ensure the integrity of food during transport would be implemented by facilities, rather than by carriers. For example, to significantly minimize or prevent a food from being intentionally adulterated during transport, a shipper may elect to use seals to secure access points, such as doors or hatches, on the transport conveyance. If a facility chooses to use seals as a mitigation strategy, and the seals are found to be broken, the facility is required to implement corrective actions (21 CFR 121.145). The IA Rule does not require a particular disposition of food when a mitigation strategy is found to be improperly implemented. Note that the compliance dates for the IA Rule depend on business size and begin on July 26, 2019.
