The intended outcome of this program expansion to RFA-FD-18-001 “Flexible Funding Model – Infrastructure Development and Maintenance for State Manufactured Food Regulatory Programs” is to advance the efforts for a nationally Integrated Food Safety System (IFSS) by assisting State manufactured
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food regulatory programs to promote compliance with the Current Good Manufacturing Practice, Hazard Analysis, and Risk-based Preventive Controls for Human Food regulation (PCHF Rule).
PCHF is intended to ensure safe manufacturing/processing, packing and holding of food products for human consumption in the United States.
This program expansion provides funding to incorporate PCHF activities into the existing human food safety framework being implemented by the grantees under RFA-FD-18-00 1. By participating in this program expansion, grantees will develop infrastructure, programs, and trained personnel to support full adoption and implementation of the PCHF Rule, which may include:Establishing a PCHF training coordination/monitoring program for their regulatorsDeveloping an inspection and compliance program to conduct full-scope Preventive Control Rule inspections under 21 CFR Part 117,Establishing data information sharing capabilities with FDA and work planning activities promoting an IFSS,Enhancing state regulatory foundations, including regulatory drafting, legislative research, and support for statute modernizationBuilding capacity to support a Preventive Controls program.For the purposes of this FOA, the term State encompasses all eligible organizations as defined in Section 3