# FSMA Human Foods Preventive Controls Implementation Expansion in Georgia

> **NIH FDA U18** · GEORGIA STATE DEPARTMENT OF AGRICULTURE · 2020 · $150,000

## Abstract

Project Summary
The Georgia Department of Agriculture (GDA) will continue collaborative and promotional efforts for the
advancement of a food safety system based on mutual reliance and shared responsibility with the U.S. Food
and Drug Administration (FDA) and other stakeholders. The overall objective of this project is full
implementation of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-based Preventive
Controls for Human Food regulation (PCHF Rule) into the Manufactured Food Program and a nationally
Integrated Food Safety System (IFSS). Our overarching goal as a state regulatory authority is to reduce the
risk-factors that are known to cause or contribute to foodborne illness in firms that manufacture, process, hold,
or pack food.
Objectives for this project include the following: a) incorporating the PCHF Rule into Manufactured Food
Regulatory Program Standards (MFRPS) Training Program requirements and conducting an evaluation to
identify and document any improvements to the training plan that are needed to promote evidence collection
and support possible regulatory actions; b) expanding the Auditing Program by moving toward implementing
Phase III audits and collecting audit data on full-scope PCHF inspections, as well as participating in the
development and piloting of the audit criteria; c) identifying and remedying gaps in GDA's infrastructure
necessary to implement the PCHF Rule as part of the manufactured food regulatory program; d) establishing
an inspection and compliance program which incorporates the PCHF Rule that includes engaging with FDA to
participate in workplanning, work-sharing, and data exchange efforts; e) determining any necessary activities
to adopt, incorporate, reference, or utilize the PCHF Rule, including other rules promulgated under the
authority of FSMA; f) developing an outreach plan and associated materials related to the PCHF regulation and
compliance and other FSMA related rules as part of GDA's overall outreach plan; and g) meeting with FDA as
necessary to develop/monitor workplanning progress for dual inspected facilities including updating guidance
documents and participation in pilot projects to advance joint workplanning, information sharing, firm
reconciliation and enforcement action between Georgia and FDA.
The aims for this project include a) incorporating the PCHF Rule into the training program; b) implementing
Phase III in the Audit Program; c) program improvement and infrastructure development; d) preventive controls
inspection and compliance implementation strategies; e) legislative research, rulemaking and policy analysis; f)
developing an outreach plan and associated materials related to the PCHF rule; and g) joint workplanning and
enforcement with the FDA.

## Key facts

- **NIH application ID:** 10168772
- **Project number:** 3U18FD006390-03S1
- **Recipient organization:** GEORGIA STATE DEPARTMENT OF AGRICULTURE
- **Principal Investigator:** Natalie Adan
- **Activity code:** U18 (R01, R21, SBIR, etc.)
- **Funding institute:** FDA
- **Fiscal year:** 2020
- **Award amount:** $150,000
- **Award type:** 3
- **Project period:** 2018-09-01 → 2021-06-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10168772

## Citation

> US National Institutes of Health, RePORTER application 10168772, FSMA Human Foods Preventive Controls Implementation Expansion in Georgia (3U18FD006390-03S1). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/10168772. Licensed CC0.

---

*[NIH grants dataset](/datasets/nih-grants) · CC0 1.0*