FDA FSMA Preventive Controls for Human Food 21 CFR 117
US FSMA rule requiring food facilities to implement a food safety plan with hazard analysis, preventive controls, monitoring, corrective actions, and verification. Equivalent to EU HACCP requirements. Relevant for US-export FMCG manufacturers.
Sectors
Articles (61)
Applicability and status.Definitions.Qualifications of individuals who manufacture, process, pack, or hold food.Exemptions.Applicability of subparts C, D, and G of this part to a facility solely engaged in the storage of unexposed packaged food.Applicability of subpart B of this part to the off-farm packing and holding of raw agricultural commodities.Records required for this subpart.Personnel.Plant and grounds.Sanitary operations.Sanitary facilities and controls.Equipment and utensils.Processes and controls.Warehousing and distribution.Holding and distribution of human food by-products for use as animal food.Defect action levels.Food safety plan.Hazard analysis.Preventive controls.Circumstances in which the owner, operator, or agent in charge of a manufacturing/processing facility is not required to implement a preventive control.Provision of assurances required under § 117.136(a)(2), (3), and (4).Recall plan.Preventive control management components.Monitoring.Corrective actions and corrections.Verification.Validation.Verification of implementation and effectiveness.Reanalysis.Requirements applicable to a preventive controls qualified individual and a qualified auditor.Implementation records required for this subpart.Modified requirements that apply to a qualified facility.Modified requirements that apply to a facility solely engaged in the storage of unexposed packaged food.Circumstances that may lead FDA to withdraw a qualified facility exemption.Issuance of an order to withdraw a qualified facility exemption.Contents of an order to withdraw a qualified facility exemption.Compliance with, or appeal of, an order to withdraw a qualified facility exemption.Procedure for submitting an appeal.Procedure for requesting an informal hearing.Requirements applicable to an informal hearing.Presiding officer for an appeal and for an informal hearing.Timeframe for issuing a decision on an appeal.Revocation of an order to withdraw a qualified facility exemption.Final agency action.Reinstatement of a qualified facility exemption that was withdrawn.Records subject to the requirements of this subpart.General requirements applying to records.Additional requirements applying to the food safety plan.Requirements for record retention.Requirements for official review.Public disclosure.Use of existing records.Special requirements applicable to a written assurance.Requirement to establish and implement a supply-chain program.General requirements applicable to a supply-chain program.Responsibilities of the receiving facility.Using approved suppliers.Determining appropriate supplier verification activities (including determining the frequency of conducting the activity).Conducting supplier verification activities for raw materials and other ingredients.Onsite audit.Records documenting the supply-chain program.