U2FFD007444

Path C Maryland Department of Agriculture Produce Safety Program - Project Title: Maryland Department of Agriculture (MDA) Path C Produce Safety Program

Project Description: The FDA Produce Safety Rule has been adopted in its entirety into the Maryland Annotated Code Agriculture Article Maryland Produce Safety Program §§16-101 to 16-111 2019. MDA will follow Program Path C, Regulatory Band 6, and Education and Inventory Band 7, as outlined in FOA PAR-21-174, to further develop and implement the Maryland Produce Safety Program. The MD Secretary of Agriculture designated inspection and enforcement authority for Subpart M to the Maryland Department of Health as they already regulate sprout growers jointly with FDA. The project will be a collaborative effort with FDA and regulatory and education partners to create and implement a program that achieves high rates of compliance with the FDA Produce Safety Rule.

Project Overarching Goal: To enhance, develop, and implement a Maryland Produce Safety Program with a focus on quality and national consistency by conducting assessment, planning, regulatory, and educational activities to meet the program objectives.

Program Objectives:
1. Conduct assessments of the Maryland produce landscape, produce-related event response, and program resources to develop a plan for accomplishing program objectives.
2. Establish foundational resources to implement the plan and ensure program continuity.
3. Provide education, outreach, and technical assistance focused on compliance with the FDA Produce Safety Rule.
4. Establish a complete and accurate inventory of Maryland produce farms by fully verifying all FDA and MDA required data elements.
5. Develop and implement an inspection program focused on quality and national consistency that is fully integrated with other food safety agencies.
6. Develop and implement a risk-based compliance and enforcement program with a framework for progressive enforcement actions resulting in the greatest protection of public health.
7. Build on the current rapid response team structure and authorities to establish capabilities for a coordinated response to all produce-related events that are likely to result in illness, injury, or outbreak.

Expected Outcomes: The plans, partnerships, collaboration, and activities of this project will result in a Maryland Produce Safety Program that enhances produce safety and protects public health as part of an integrated food safety system. Education and technical assistance will provide Maryland produce farms with the tools to achieve compliance with the FDA Produce Safety Rule. Inspection, compliance, and enforcement activities will further achieve high compliance rates with the FDA Produce Safety Rule. A fully coordinated response to produce-related events will reduce the impact of produce contamination on public health.

Maryland Department Of Agriculture

TO ASSIST INSTITUTIONS AND ORGANIZATIONS, TO ESTABLISH, EXPAND, AND IMPROVE RESEARCH, DEMONSTRATION, EDUCATION AND INFORMATION DISSEMINATION ACTIVITIES, ACQUIRED IMMUNODEFICIENCY SYNDROME (AIDS), BIOLOGICS, BLOOD AND BLOOD PRODUCTS, THERAPEUTICS, VACCINES AND ALLERGENIC PROJECTS, DRUG HAZARDS, HUMAN AND VETERINARY DRUGS, CLINICAL TRIALS ON DRUGS AND DEVICES FOR ORPHAN PRODUCTS DEVELOPMENT, NUTRITION, SANITATION AND MICROBIOLOGICAL HAZARDS, MEDICAL DEVICES AND DIAGNOSTIC PRODUCTS, RADIATION EMITTING DEVICES AND MATERIALS, FOOD SAFETY AND FOOD ADDITIVES. THESE PROGRAMS ARE SUPPORTED DIRECTLY OR INDIRECTLY BY THE FOLLOWING CENTERS AND OFFICES: CENTER FOR BIOLOGICS EVALUATION AND RESEARCH (CBER), CENTER FOR DRUG EVALUATION AND RESEARCH (CDER), CENTER FOR DEVICES AND RADIOLOGICAL HEALTH (CDRH), CENTER FOR VETERINARY MEDICINE (CVM), CENTER FOR FOOD SAFETY AND APPLIED NUTRITION (CFSAN), NATIONAL CENTER FOR TOXICOLOGICAL RESEARCH (NCTR), THE OFFICE OF ORPHAN PRODUCTS DEVELOPMENT (OPD), THE CENTER FOR TOBACCO PRODUCTS (CTP), AND OFFICE OF REGULATORY AFFAIRS (ORA), AND THE OFFICE OF THE COMMISSIONER (OC). SMALL BUSINESS INNOVATION RESEARCH (SBIR) PROGRAMS: TO STIMULATE TECHNOLOGICAL INNOVATION, TO ENCOURAGE THE ROLE OF SMALL BUSINESS TO MEET FEDERAL RESEARCH AND DEVELOPMENT NEEDS, TO INCREASE PRIVATE SECTOR COMMERCIALIZATION OF INNOVATIONS DERIVED FROM FEDERAL RESEARCH AND DEVELOPMENT, AND TO FOSTER AND ENCOURAGE PARTICIPATION BY MINORITY AND DISADVANTAGED PERSONS IN TECHNOLOGICAL INNOVATION. FUNDING SUPPORT FOR SCIENTIFIC CONFERENCES THAT ARE RELEVANT TO THE FDA SCIENTIFIC MISSION AND PUBLIC HEALTH ARE ALSO AVAILABLE.

93.103 - Food and Drug Administration Research

FDA Office of Acquisition and Grant Services (OAGS) [HHS - FDA]

FDA Office of Regulatory Affairs (ORA) [HHS - FDA]

Annapolis, Maryland 214018960 United States

Single Zip Code

The FDA's Cooperative Agreement Program for States and Territories to Implement a National Produce Safety Program (U2F) Clinical Trials Not Allowed (PAR-21-174)

Amendment Since initial award the total obligations have increased 272% from $523,497 to $1,945,475.