Food Safety Modernization Act and Human Food

There are seven major components of the Food Safety Modernization Act (FSMA). The Oregon Department of Agriculture (ODA) Food Safety Program focuses on ‘Preventive Controls for Human Food.’

ODA amended OAR 603-025 to adopt the 2017 version of Code of Federal Regulations (CFRs). This includes subparts A, B, C, D, E, F, and G of the Current Good Manufacturing Practice, Hazard Analysis, and Risk Based Preventive Controls for Human Food.

The rule changes apply to all food processors, bakeries, and warehouses. The new rules require all firms to conduct a hazard analysis. If a biological, chemical, or physical hazard is identified, a firm must develop a system with controls to prevent the hazard.

• Firms that have identified a hazard must follow all the requirements of the new preventive controls rules. The inspections are called 'full scope' inspections.
• Firms that do not identify a hazard, must follow the current Good Manufacturing Practices. This includes record keeping for training. The inspections are called 'limited scope preventive controls' inspections.

There are many industry type exemptions identified in Subpart A of 21 CFR 117.5. Additionally, some food industries may be exempt from Subpart C – Preventive Controls and Subpart G – Supply Chain Program as they relate to controlling microorganisms of public health concern. These industries are low acid food processors, juice HACCP and seafood HACCP firms, and dietary supplements. These types of processors may still need to address physical and chemical hazards through Subparts C and G.

ODA created a series of guidance documents to provide an overview of the new regulations to assist firms as they transition from 21 CFR 110 to 21 CFR 117. The guidance provides a summary of these new laws.

• FSMA final rule on preventive controls for human food

  Current good manufacturing practice, hazard analysis, and risk-based preventive controls for human food.

• FSMA guidance document summary

  Overview and summary information for this series of guidance documents on the Food Safety Modernization Act (FSMA) and food safety.

• FSMA guidance document series—1: Intro to Subparts A through G

  Brief introduction to the Subparts A through G of 21 CFR 117.

• FSMA guidance document series—2: Overview of Subparts A, B & F

  Overview of 21 CFR 117 Subparts A (General Provisions), B (current Good Manufacturing Practices, cGMP Limited Scope), and F (Requirement Applying to Records that must be Established and Maintained).

• FSMA guidance document series—3: Overview of Subparts C & G

  Overview of 21 CFR 117 Subparts C (Hazard Analysis and Risk-Based Preventive Controls) and G (Supply-Chain Program).

• FSMA guidance document series—4: Overview of prevention rules

  Overview of prevention rules including preventive controls, intentional adulteration, sanitary transport, and foreign supplier verification.

• FSMA guidance document series—5: Overview of compliance rules

  Overview of compliance rules including facility registration, attestation, food defense, and small entity guidance.

• FSMA guidance document series—6: Overview of Subparts A & E

  Overview of 21 CFR 117 Subparts A (focus on Exemptions and Training Requirements) and E (focus on Loss of an Exemption).

• FSMA guidance document series—Resources

  Resources and URLs to access related information online.