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

> **NIH FDA U18** · MASSACHUSETTS STATE DEPARTMENT OF AGRICULTURAL RESOURCES · 2020 · $733,206

## 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 organization:** MASSACHUSETTS STATE DEPARTMENT OF AGRICULTURAL RESOURCES
- **Principal Investigator:** Michael Botelho
- **Activity code:** U18 (R01, R21, SBIR, etc.)
- **Funding institute:** FDA
- **Fiscal year:** 2020
- **Award amount:** $733,206
- **Award type:** 5
- **Project period:** 2016-09-05 → 2021-06-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/9967816

## Citation

> US National Institutes of Health, RePORTER application 9967816, The Integration and Implementation of FDA's Produce Safety Rule and The Commonwealth Quality Program (5U18FD005904-05). Retrieved via AI Analytics 2026-05-28 from https://api.ai-analytics.org/grant/nih/9967816. Licensed CC0.

---

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