NEBRASKA'S MAINTENANCE OF THE ANIMAL FEED REGULATORY PROGRAM STANDARDS WITH PREVENTIVE CONTROL REGULATORY ACTIVITIES AND CAPACITY BUILDING

NIH RePORTER · FDA · U18 · $360,000 · view on reporter.nih.gov ↗

Abstract

Project Summary/Abstract for PAR-20-132 Development and Maintenance of the Animal Feed Regulatory Program Standards with Optional Coordinated Preventive Control Regulatory Activities and Capacity Building (U18) Clinical Trial Not Allowed. The Nebraska Department of Agriculture (NDA) and its Commercial Feed Program are excited for the opportunity to continue its effort of maintaining the Animal Feed Regulatory Program Standards in the State of Nebraska, and incorporating the Preventive Controls Initiative into a state level equivalency. The State Program's goals in maintaining full implementation of AFRPS is to maintain its animal food safety contract in good standing with FDA throughout the period of the contract agreement; continue meeting all reporting obligations of the cooperative agreement along with usage of the Improvement Plan from Standard 9 to track and implement changes and improvements; maintain risk-based firm inventory and enhance the criteria for determining risk. The State Program conducted a preliminary statewide industry survey across different animal food manufacturers and distributers to assess their readiness and knowledge of 21 CFR 507. The Preventive Control Initiative funding will allow the State Program to hire a new staff member dedicated to PC and CGMP education and outreach, which will be directed toward the lower and mid- tier manufacturers and distributers as a result of the State Program survey. The outreach and education plans include but are not limited to mailing information to firms, holding regional workshops, and collaborating with outside educators. The State Program plans to repeat its survey toward the end of the 5-year cooperative agreement to assess success of the outreach plan. Along with outreach and education, the State Program will move towards Phase 2 and Phase 3 audits as described in Field Management Directive (FMD)-76, by year 5 of the cooperative agreement. NDA and the Commercial Feed Program believe they will make the most of this funding opportunity to build upon the progress already achieved under AFRPS. With the addition of the PC Initiative funding, this opportunity will help NDA meet their purpose of safeguarding human food and animal health, ensuring feed is safe, unadulterated, and honestly prepared.

Key facts

NIH application ID
10175501
Project number
1U18FD007192-01
Recipient
NEBRASKA ST DEPARTMENT OF AGRICULTURE
Principal Investigator
Charles Hubenka
Activity code
U18
Funding institute
FDA
Fiscal year
2020
Award amount
$360,000
Award type
1
Project period
2020-09-01 → 2025-06-30