The Integration and Implementation of FDA's Produce Safety Rule and The Commonwealth Quality Program

NIH RePORTER · FDA · U18 · $733,206 · view on reporter.nih.gov ↗

Abstract

Project Summary Project Title: The Integration and Implementation of FDA’s Produce Safety Rule and the Commonwealth Quality Program (CQP) Project Description: The Massachusetts Department of Agricultural Resources (MDAR) intends to continue its current voluntary farm food safety program in Massachusetts, and integrate FDA’s Produce Safety Rule, into a comprehensive and scalable produce safety program in Massachusetts. We intend to develop a strategic plan to implement this initiative in full compliance with FSMA’s Produce Safety Rule. This strategic plan will include education and training for produce farmers covered under the rule, as well as implementation of a regulatory and operational framework in support of the state program. Project Goals: The proposed project will develop a strategic plan for alignment of MDAR’s existing regulations, programs and activities with FDA’s Produce Safety Rule. Goals include establishing an inventory of covered produce farms, benchmarking current program operations and procedures alongside proposed initiatives, developing an educational plan for the continued provision of training on the state’s produce safety program and the Produce Safety Rule for farmers, completing an assessment of MDARs regulatory authority for produce safety and the resources needed to develop a successful program, and implement the program. Expected Outcomes: It is our intent that the work outlined in this proposal will create a federal-state relationship which will leverage the existing expertise, knowledge and resources of the Massachusetts Department of Agricultural Resources resulting in the continued and consistent delivery of a state produce safety program as envisioned by MDAR and the FDA. Project Objectives: 1) Develop, integrate and maintain an inventory (database) of produce farms covered under the rule, including a mechanism to share the data with the FDA. 2) Determine and assess the resources needed to conduct activities under a state produce safety program, that has been aligned with FDA’s Produce Safety Rule (identify metrics & develop and deploy plans for the training, technical support/assistance for covered farms, identify develop and deploy information technology, sampling and laboratory capabilities, & inspection/compliance activities). 3) Develop and implement a five year strategic plan that includes educating producers on produce safety and providing regulatory oversight for covered produce in Massachusetts. The plan will include program administration and operations, on-farm inspections and audits, environmental and product sampling, compliance and enforcement, training, education and technical assistance. Budget: $499,916 for year one, $717,262 for year two, $747,775 for year three, $762,447 for year four and $852,248 year for five, totaling $3,579,649 for the five year grant period.

Key facts

NIH application ID
9967816
Project number
5U18FD005904-05
Recipient
MASSACHUSETTS STATE DEPARTMENT OF AGRICULTURAL RESOURCES
Principal Investigator
Michael Botelho
Activity code
U18
Funding institute
FDA
Fiscal year
2020
Award amount
$733,206
Award type
5
Project period
2016-09-05 → 2021-06-30