Food safety management and document development for PCHF Rule qualified exemption-eligible food facilities

The Preventive Controls for Human Food (PCHF) Rule of FSMA represents thefirst major update of U.S. food safety programs since the Food, Drug, and Cosmetic Act was signed in 1938.While small and very small manufacturers are eligible for qualified exemptions from parts of the rule, notably the need for a formal Hazard Analysis and Preventive Control Plan in Subparts C and G, these facilities are still required to follow the current Good Manufacturing Practices (GMPs) as well as FSMA-specific requirements for record keeping and training of personnel training in other Subparts of the PCHF Rule. Attestation that shows a manufacturer to be qualified for exemption is necessary, including documentation demonstrating the company to be a small or very smallbusiness following the economic parameters which defines qualified exempt facilities.The introduction of new food safety regulations creates a need for education and training which is often facilitated through university Extension and community partners. While small and very small food manufacturers are a recognized group eligible for qualified exemptions, these same characterizing attributes make the existing Preventive Controls for Qualified Individuals (PCQI) training excessive and not specific to their needs. Following this gap in assistance, the project training envisioned in this proposal will include the introduction of specific trainingfor qualified exempt food producers to meet regulatory requirements, including exemption attestation under FSMA, food safety management, cGMPs, and employee training.Another crucial point emphasized in the proposed training is the fact that "no food business is exempt from producing safe food." So, while qualified exemption-eligible food businesses are not subject to Subparts C and G under the PCHF Rule, this training will also address hazard analysis and management for small food processors. Relevant vegetative pathogens including diarrheagenicEscherichia coli, non-typhoidalSalmonella enterica, andListeria monocytogenesare inactivated through thermal processing, chemical pasteurization, or a combination of the two. Understanding these principles and guidance for temperature control to prevent proliferation and toxin production by other foodborne bacterial pathogens is essential for food safety, regardless of if it is explicitly managed under a Food Safety Plan. In hermetically sealed containers, the risk forClostridium botulinumgermination and toxin production also becomes significant. Acidified food producers are required to file their processes with FDA per 21 CFR Part 114, which does not exempt them from Subpart C or G of the Preventive Controls for Human Food (PCHF) Rule of FSMA.Manyproducts of small food businesses are variably sold through direct distribution (Farm Markets, on-farm sales), retail (groceries, restaurants), and increasingly complex supply chains, making their impact on public health a relevant consideration. Because many of the processors are small, independent businesses, outreach and education that is specific to their needs rather than large-scale food manufacturers is necessary. Additionally, the growing popularity of shared-use kitchens/food business incubators introduces additional concerns regarding chemical hazards and allergen cross-contact in these shared spaces.Food safety management among small food processors must address the issue of resource limitation (Plimpton, 2017). Many small food processors lack dedicated staff with expertise and job responsibilities directed toward food safety. Food safety training workshops or courses often involve direct costs (e.g. course registration and travel expenses) as well as indirect costs (e.g. production down time) and food processors wish to see a return on their investments (ROI). In this proposed training, ROI is promoted because participants use the workshop time to develop that facilitates regulatory requirement compliance. To address the additional challenges facing small food businesses, we propose a half-day training marketed to qualified exemption-eligible food processors that integrates previous FSOP deliverables from other regional centers, pilot projects, and needs assessments performed by collaborators. The goal is to have a modular training series, a network of experienced Extension personnel capable of offering the training in years to come, and an online version of the training so that consistent access is available to this optimized curriculum.The goal of this project is to increase FSMA preparedness among qualified exemption-eligible food processors through a national training program with long-term sustainability.This will be accomplished through the following objectives:Optimize a generalizable curriculum and templates for qualified exemption-eligible facilities through coordination with a national network of Extension professionals.Provide small-group training sessions and individualized guidance to qualified exemption-eligible food processors in the development of FSMA documentation through trainings offered in several regions within collaborative states.Develop a web-based platform for online training courses to facilitate remote access and long-term training use nationwide.The project specifically targets an underserved niche of food processors.The outcomes of this project will support FSMA preparedness and increase food safety knowledge for this target group, which in turn contributes to industry sustainability and positive impacts on public health. This project is being developed with a national audience in mind while focusing hands-on trainings throughout states located in the Northeast region with additional trainings offered in more distant regions. The resources developed in this project will be shared with the associated regional centers.