Empowering Farmers to Comply with Food Safety Modernization Act (FSMA) Preventive Controls for Human Foods (PCHF)

Project Overview

Project Type: Research and Education
Funds awarded in 2020: $162,545.00
Projected End Date: 12/31/2023
Grant Recipients: The University of Scranton Small Business Development Center; The Pennsylvania State University
Region: Northeast
State: Pennsylvania
Project Leader:
Lisa Hall Zielinski
The University of Scranton Small Business Development Center

Information Products


Not commodity specific


  • Crop Production: food product quality/safety
  • Education and Training: decision support system, mentoring, technical assistance
  • Farm Business Management: budgets/cost and returns, new enterprise development, risk management, value added
  • Sustainable Communities: local and regional food systems, new business opportunities

    Proposal abstract:

    Problem and Justification: Farmers marketing directly often add value, making shelf-stable products to increase revenues. Many producers opt for farm kitchen production, such as Limited Food Establishments (Pennsylvania) or the Cottage Food Law (Maryland), making food for in-state, direct-to-consumer (FSMA exempt) sales. However, producers of shelf-stable products (accessing retailers, institutions, or internet sales) must be PCHF-compliant. Sustainable FSMA-era adding value requires defining a target market, determining compliance costs, investing time/money in training, and writing a plan that proactively reduces/eliminates, all POTENTIAL food safety hazards. Producers adding value must also consider consumer expectations. Lacking the face-to-face farmers’ market interaction, food packages “stand alone,” and transparently provide complete, accurate substantiation of food safety and quality (Quality Assurance and Food Safety, 2017). Since its 2011 inception FSMA has not been easy to understand - so producers need assistance to select and adopt appropriate practices. Although the Iowa State University food processors’ FSMA Compliance Checklist (Overdiep & Shaw, 2019) clarifies FSMA, and Extension and PA Farmers Union provide Produce Rule guidance, there is currently no documentation of hands-on assistance for producers in PCHF compliance.  

    Solution and Approach: Per the Journal of Extension, “FSMA compliance information and technical assistance could help (farmers) enter larger, more profitable markets, enhancing the prospect of expanding their businesses, which otherwise would have to remain low in profit to continue to be exempt. For medium-sized nonexempt farmers and processors, the information would be critical for continued access to the market.”  (Fouladkhah, 2017). Farmers’ largest hurdle is to see adding value in a new light – determining where something might “go wrong” that will compromise the safety of their product, and identifying preventive controls to address these hazards. Our project team proposes to coach producers through the process, empowering them to: judge how/if PCHF applies to them, identify appropriate food safety training, utilize project team-developed decision tools to determine preventive controls, and access the FDA Food Safety Plan App to write compliant plans.

    Milestones and Performance Target:  Initially, 120 women and small-scale producers will attend “FSMA Made Simple” (FMS) learning how/if PCHF applies to them. 65 producers will decide to remain home-based or stop adding value, saving time and money to invest elsewhere on the farm. The remaining 55 will investigate the scale of safety activity and investment needed for shelf-stable adding value; 35 will attend Good Manufacturing Practice training, gain state registration, and apply for FDA Qualified Exemption to PCHF – developing a sales records paper trail to confirm >50% direct sales. The remaining 20 will become Preventive Control Qualified Individuals (PCQIs); writing, validating and adopting food safety plans needed for transparent food safety standards. All 55 producers will have transparent food safety standards that improve their social (consumer-focused) and economic (FSMA-compliant) sustainability.

    Performance targets from proposal:

    55 producers will gain capacity to determine the FSMA PCHF rule’s impact for their current/planned value-added enterprises; 35 will adopt GMPs and records supporting FDA Qualified Exemption, and 20 will draft/implement a PCHF food safety plan, resulting in producers reporting $16,000 (average) increased revenues.

    Any opinions, findings, conclusions, or recommendations expressed in this publication are those of the author(s) and do not necessarily reflect the view of the U.S. Department of Agriculture or SARE.