# Kentucky's FSMA Human Foods Preventive Controls Implementation Expansion Submission

> **NIH FDA U18** · KY ST CABINET/HEALTH/FAMILY SERVICES · 2020 · $25,000

## Abstract

Project Abstract
The Commonwealth of Kentucky is applying for federal funds to conduct activities that will
enable the Food Safety Program of the Kentucky Department for Public Health’s Division of
Public Health Protection and Safety to adopt and implement the risk-based Preventive Controls
for Human Food regulation (PCHF Rule), as described in the Code of Federal Regulations (21
CFR 117). Currently, the state has adopted by reference 21 CFR 117 by incorporation into The
Kentucky Food Processing, Packaging, Storage, and Distribution Operations Regulation (902 KAR
45:160), which establishes procedures and requirements for food processing, packaging,
storage, and distribution operations in Kentucky. This state regulation mirrors the specific FDA
requirements for food firms, food plant requirements regarding plan review, construction and
maintenance, water supply, plumbing, sewage disposal, toilet facilities, hand washing facilities,
and food transportation. In 2017, 902 KAR 45:160 also incorporated the FDA’s Food Safety
Modernization Act (FSMA) Final Rule on Preventive Controls for Human Food. However, full-
scope implementation of the PCHF Rule by the Food Safety Program has been limited by the
availability of qualified auditors in the state, as well as by insufficient technical resources for
data processing and information sharing.
The Food Safety Branch intends to use these funds to hire and train two state auditors (within
two years) to conduct Phase III inspections of food manufacturing facilities to meet FDA
standards. The auditors will be auditing the state inspectors. In addition, a computer
application database called KY First will be enhanced to communicate with the FDA’s system
(NSFDX) and result in reducing the amount of time staff use for data entry.

## Key facts

- **NIH application ID:** 10175637
- **Project number:** 3U18FD006408-03S1
- **Recipient organization:** KY ST CABINET/HEALTH/FAMILY SERVICES
- **Principal Investigator:** Rebecca Gillis
- **Activity code:** U18 (R01, R21, SBIR, etc.)
- **Funding institute:** FDA
- **Fiscal year:** 2020
- **Award amount:** $25,000
- **Award type:** 3
- **Project period:** 2018-09-01 → 2021-06-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10175637

## Citation

> US National Institutes of Health, RePORTER application 10175637, Kentucky's FSMA Human Foods Preventive Controls Implementation Expansion Submission (3U18FD006408-03S1). Retrieved via AI Analytics 2026-05-25 from https://api.ai-analytics.org/grant/nih/10175637. Licensed CC0.

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