Document Development and Management Training for Small-Scale Processors of Fermented, Acid, and Acidified Foods

Value-added specialty products are a sector of the food industry popular among diverse small and medium-scale food businesses. While many of these firms are large in size, small and medium-scale processors, who may or may not generate extremely high product volume, do represent a significant number of the licensed food facilities in both Ohio and California.The total number of facilities manufacturing fermented or acidified foods is difficult to parse exactly. For example, many small and medium-sized producers of fermented and acidified foods operate through shared use kitchens and co-packers, producing seasonably or variably depending on the market. This leads to an underestimate of the number of producers in the market, and difficulty in accessing this community through conventional food safety trainings. Fermented and acidified food processors represent a significant portion of the total number of food businesses, and manufacture products which require some degree of technical backing to control relevant food safety hazards. However, their size, diffuse and independent business structure, and (in the case of acidified foods and alcoholic beverage manufacturers) current engagement with other germane regulations limits their awareness and accessibility to some of the available Food Safety Modernization Act (FSMA) training, and the relevance of the bulk of this training to their specific needs. Therefore, we propose the development and pilot-scale implementation of training targeting fermented and acidified food (FAF) producers.Shelf-stable, low pH products may variably be considered naturally high acid, fermented or acidified, depending on production method and formulation. Fermented foods are acidified through the production of organic acids by the metabolism of bacteria. In the production of fermented vegetable products, that is often accomplished through the addition of salt to both inhibit the outgrowth of vegetative pathogens and facilitate the growth of lactic acid bacteria found natively on the plant material. The safety of other fermented foods may variably be controlled through production of ethanol and through competitive exclusion. In contrast, acidified foods are produced through direct addition of an acid, frequently but not exclusively acetic acid in the form of vinegar, and thermally processed for safety and stability. These represent significant food industries in Ohio and California which both have large manufacturing and specialty crop production capabilities.Food safety risk mitigation strategies for FAFs are largely based on processing and formulation conditions. Vegetative pathogens including diarrheagenic Escherichia coli, non-typhoidal Salmonella enterica, and Listeria monocytogenes are inactivated through thermal processing, chemical pasteurization, or a combination of the two. In hermetically sealed containers, the risk for Clostridium botulinum germination and toxin production also becomes significant unless otherwise controlled by pH. 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 FSMA10. Their products and processes are potentially associated with several significant hazards, however, many FAF processors are small, and may be eligible for exemption based on size as "qualified facilities." FAF products 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 needed.The Produce Safety Rule (PSR) and PCHF Rule in FSMA have changed the minimum documentation requirements for food producers. Even facilities who will be exempt from the PSR due to processing (21 CFR 112.2) or exempt from Subpart C and G of the PCHF due to size (21 CFR 117.201), must still develop and maintain documentation in support of their exemption. Moreover, the PCHF qualified size exemption does not exempt facilities from Subpart B, modernized Good Manufacturing Practices (GMPs), which now also includes documentation standards that even qualified facilities need to address (21 CFR 117.110). For FAF processors who are not qualified facilities based on size, a food safety plan including the hazard analysis and relevant preventive controls is required. Acidified food producers are already subject to 21 CFR Part 114, the Acidified Food Rule, that requires them to file a scheduled process, as 21 CFR Part 113 requires for Low Acid Canned Foods (LACF). However, unlike LACF which has microbiological hazards exempt from PCHF food safety plan development, acidified food producers still must develop a food safety plan that addresses their microbiological hazards8. Therefore, they will need to convert their scheduled process into a hazard analysis and preventive control plan. The development of this documentation - exemptions, GMPs, and conversion of a scheduled process into a hazard analysis and food safety plan is not addressed in currently available curricula including Preventive Controls Qualified Individual Training (PCQI) and Better Process Control School (BPCS). Many FAF processors are small food producers and do not have nor will they hire someone with dedicated food safety expertise. Instead, they will rely heavily on local food safety inspectors, university Extension services, and third-party consultants in order to become informed of and develop appropriate response to these changing food safety regulatory standards.Document development is often one of the greatest perceived barriers to regulatory compliance for small and inexperienced processors. Concise hands-on instruction with guided exercises and feedback can increase preparedness among FAF producers which would both promote public health by increasing control over food safety hazards as well as improve regulatory compliance, FSMA implementation and enforcement, and industry satisfaction by increasing FAF processor resources and knowledge. FAFs represent an important part of the local foods sector and these manufacturers are a particularly vulnerable group often with limited resources available to reallocate towards facilitating regulatory compliance. Some acidified food processors already feel burdened by the pre-existing restrictions and requirements including BPCS, Process Authority services, and filing. In order to bolster sustainability of FAF processors, hands-on training in document development for FAF processors would help alleviate this burden faced by these manufacturers. While FAF producers often represent high risk products, processors are frequently small with limited resources available for training, consultation, and professional development. Filling in these existing knowledge gaps and direct transfer of template documents and resources through local Extension programming connected with shared use kitchens and farm markets is the most effective strategy.The goal of this project is to increase FSMA preparedness among FAF processors by delivering targeted, customized training and associated resources necessary in document development and management.