Source: CORNELL UNIVERSITY submitted to NRP
FOOD SAFETY MANAGEMENT AND DOCUMENT DEVELOPMENT FOR PCHF RULE QUALIFIED EXEMPTION-ELIGIBLE FOOD FACILITIES
Sponsoring Institution
National Institute of Food and Agriculture
Project Status
COMPLETE
Funding Source
Reporting Frequency
Annual
Accession No.
1020892
Grant No.
2019-70020-30357
Cumulative Award Amt.
$400,000.00
Proposal No.
2019-04220
Multistate No.
(N/A)
Project Start Date
Sep 1, 2019
Project End Date
Aug 31, 2022
Grant Year
2019
Program Code
[A4182]- Regional FSMA Center
Recipient Organization
CORNELL UNIVERSITY
(N/A)
ITHACA,NY 14853
Performing Department
Food Science
Non Technical Summary
Very small food processors represent an important section of the food industry. Small processors are popular among consumers, may have limited institutional access and resources to food safety training, and have a high degree of turnover in personnel and even in business. Some of these processors only produce seasonally, while others may only stay in business for a year or two. Yet, other new businesses are consistently starting. This poses a challenge for implementation of food safety regulations and transmission of food safety education among this specialized group.This is no less true for the Preventive Controls for Human Food (PCHF) Rule of FSMA. Existing curricula including PCQI training does not address the needs of this specialized community of small and very small processors, a fact which has been recognized by several land grant university extension programs and funded through previous FSOP grants, including the two pilot projects from the PD and Co-I. However, short-term (1-3 year) access to the training offered at one location within a state has not fully addressed these needs.To address this on a broader basis, we propose the curation of the curriculum previously piloted by PD-Snyder to integrate products from other regionally specific and diverse, previous FSOP projects in the development of a national 0.5-day training program appropriate for qualified facilities. This content will be implemented on a national basis within each collaborating state and provided as online content for more distal locations and to support sustainable content access in future years.
Animal Health Component
(N/A)
Research Effort Categories
Basic
(N/A)
Applied
(N/A)
Developmental
(N/A)
Classification

Knowledge Area (KA)Subject of Investigation (SOI)Field of Science (FOS)Percent
71250103020100%
Goals / Objectives
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.
Project Methods
Objective 1:Optimize a generalizable curriculum and templates for qualified exemption-eligible facilities through coordination with a national network of Extension professionals.Process:Through collaboration with other states and regional centers, we will gather related material and findings geared toward food safety education among qualified facilities. This includes already identified results from needs assessments and pilot programs in multiple regions. Material will be reviewed by project key personnel and optimization of PD-Snyder's pilot curriculum will be made, with a modular unit with built-in flexibility to accommodate state-specific guidelines. For example, prior to traveling to a state for hands-on training, key personnel will work with food safety experts within the state to determine how state-specific cottage food laws impact small food processors. The distinctions among cottage food operations, acidified food rules, and regulations pertaining to qualified exemption-eligible processors will be discussed in this module.Objective 2: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.Process:The collaboration with food safety extension programs in other states described in Obj.1 will be leveraged in this objective to implement hands-on food safety trainings throughout the U.S. but with an emphasis in the Northeast and North Central regions. This network of experienced trainers will contribute to building a multi-state network for food safety plan workshop execution (short term) and on-going food safety programming (long term). Given the barrier that extensive travel poses to small food businesses, multiple trainings will be offered regionally in each state to improve access. Depending on state size, 2-3 regional trainings will be offered. Key personnel will offer trainings in 2-3 states per year of the project for 6-9 total classes a year and 20-35 total classes throughout the duration of the project.Workshops will consist of half-day trainings limited to the first 20 applicants at each location to facilitate small group discussions and individualized attention. Trainings will be based regionally throughout each state to increase access to a diverse audience and held at collaborators' facilities in shared-use kitchens and training centers (see letters of support). Participants will be recruited through advertisements sent two months in advance to contact lists maintained by community partners and in-state collaborators and through targeted promotion from key contacts at shared use kitchens and farm markets. Participants will be charged a nominal $25 enrollment fee to increase attendance after registration and to offset small incidental costs. At the trainings, participants will be divided into smaller groups and structured workshop content generated in Obj. 1 will be used to guide participants through identification of the documentation they will need to develop. Using the templates provided, participants will also draft the needed materials and create a work list of supporting documentation to additionally obtain. Participants will be surveyed before and after participation in the course, and course evaluations and long-term follow up will also be included.Objective 3:Develop a web-based platform for online training courses to facilitate remote access and long-term training use nationwide.Process:This platform will be promoted during hands-on training as a future resource and will be available late in year 2 of the project period. The development of the material will primarily be developed by PD-Snyder and Cai, the student supported from this grant under her supervision, in collaboration with web design experts at Cornell University. The structure and content of the online training will be based on findings from the in-person training using an iterative framework for integrating feedback and improving Extension impacts (Boone and Boone, 2005, Kelsey, et al., 2005, and Lange et al., 2012).Online curriculum will incorporate theories of web design including visual hierarchy and the Gestalt principle so that emphasis is placed on overall principles and relationships among principles rather than simply focusing individual details (Lohr, 2007).Digital content development will take into consideration potential audio-visual impairment of clients and material development will accommodate those needs. Course content will be hosted by Blackboard at Cornell University and made available for a small user fee ($15). The online course will include a short pre-test/post-test composed of multiple-choice questions and the participants will receive a certificate of achievement following completion. The online course should take approximately 2 hours to complete and will target an 8thgrade reading level. The course will be advertised through Extension websites and fact sheets and promoted to our collaborative partners in other states as an additional resource.

Progress 09/01/19 to 08/31/22

Outputs
Target Audience:Small food businesses eligible for qualified exemptions from the PCHF Rule of FSMA were the audience who were reached, generally, by the products of this project. However, additionally, the food safety Extension experts who participated collaboratively in these trainings have also been considered as an audience that we have targeted. We developed curriculum materials in a format that appeals to co-instructors and which they can use independently in future years (shared on the UVM Clearing House website). We have additionally developed a modified version of this curriculum in collaboration with the Cornell Food Venture Center which will be managed by Co-I Padilla-Zakour and available for ongoing fee-based courses in future years. Our audience was primarily characterized by size because small food businesses represent a specialized audience affected by FSMA. In particular, the needs of value-added specialty product manufacturers differ from those of the broader food system because they are often "very small businesses" operating with extremely limited overhead. Meaning, compliance with food safety regulations can create a significant amount of burden for these businesses to manage even as these programs are essential for ensuring public health. Consequently, small food businesses often rely on communities of support to pool resources in order to comply with regulations and remain sustainable. These resources variably include: shared-use kitchens, where diverse processors rent time in a licensed food manufacturing facility with various equipment infrastructure for manufacture; shared distribution systems such as farm markets which allow for direct marketing and sale of specialty products where advertisement and clientele recruitment efforts are pooled; and use of university Extension resources for training and food safety technical expertise in the form of workshop and education, process authority services, and disbursement of updates and guidance on emerging food safety regulations. Therefore, we targeted small food processors because of their shared specialized needs and relationship to the PCHF Rule will allow for the most effective method of targeting local communities of food processors. Although we did not specify a particular commodity focus, we did receive a lot of engagement from acid/acidified canned foods, fermented foods, and low moisture food producers. Changes/Problems:As for everyone, the challenges posed by the COVID-19 pandemic significantly impacted our ability to offer face-to-face food safety extension training. Because we identified a high demand for this content, rather than delaying implementation of the training, during our last reporting period, we decided to invest time into re-working the training materials so that we could begin offering it under a remote format. We implemented these distanced education opportunities and identified a high-level of interest and positive evaluations. We decided to see this as an opportunity rather than a limitation because we have been able to reach a wider range of distantly located participants, potentially attracting more participation because travel restrictions were removed, and we have been able to increase accessibility with Spanish language, closed-captioning, and asynchronous access to food safety education. We also saw this as an opportunity to learn more about the best-practices and viability of virtual food safety education. To that end, we pursued a number of evaluation efforts, scholarly products, and professional development opportunities for other educators and trainees regarding distance learning, as discussed above. Due to the popularity of this content and its broad sharing across regions and platforms, we have adapted the content in a variety of formats (in-person and virtual synchronous, online asynchronous) with the intention that these materials continue to be actively used even after the grant project term. What opportunities for training and professional development has the project provided?The training series based on the adapted content for remote learning is completed. Based on input from our collaborators in each of these states, we offered flexible formatting to address individual preferences and needs. For example, courses have been offered as a series of three 1-hr sessions, as a 2-part series of 90 minute sessions, and as a 1-part 90 minute presentation supplemented with either a roundtable among university food safety specialists and state food safety regulators, a follow-up virtual office hours opportunity, or with a pre-distributed workshop booklet with access to asynchronous materials after the course. Again, the opportunity to pilot the training in Ohio for >200 processors in six sessions in 2018-2019 was an opportunity to learn about what worked and what did not work so that we could be flexible and accommodating among the preferences in different states under the unique remote training environment we now face. We also directed resources to provide Spanish language materials and trainings as a consequence of the opportunity to offer these trainings remotely. We now have presentation materials and pre-recordings in Spanish and are currently offering live Spanish courses in one state, this has been an opportunity to go above and beyond what we initially committed to providing in our grant proposal. These materials have been shared with our collaborators, are posted on our website, and are available through the UVM clearinghouse. We have also considered professional development opportunities for the students involved in this project to improve their skills working with industry and in teaching. This has included two students for whom this project served as central components of their extension-focused thesis, in addition to several other trainees who were involved in 1) offering trainings, 2) setting up the logistics and management of training administration, 3) workshop curriculum development, 4) virtual curriculum development, 5) development of the Food Venture Center partner materials for future courses, 6) translation of materials into Spanish, and 7) project evaluation. The students whose theses include elements from this project both have accepted, peer-reviewed publications regarding the outputs from this work. Additionally, one PhD student offered a technical talk at IAFP on this subject. That student recently received several awards within our department and from external organizations recognizing her involvement in this extension programming. A post-doc was also involved in the development and offering of several food safety trainings, he has since been offered and transitioned to a faculty position. How have the results been disseminated to communities of interest?Again, we have completed 23 trainings in 11 states and >2,000 people have participated in these workshops. We also know that, while collaborators in 11 states were directly involved, we had participants in additional states beyond those 11 participate in workshops, expanding our reach. An abstract for this project was presented at the Northeast Regional Training Centers annual meeting and at the annual Project Directors meeting. We have a manuscript accepted for publication summarizing our experiences transitioning FSMA add-on content for very small food businesses into a manuscript. As the termination of this grant-supported period of work on the project approached, we dedicated significant efforts to focus on the development and dissemination of free-standing tools (recordings, online course curriculum, digital resources, and shared tools with other educators) to help ensure the continued use of these resources long-term. Most notably, that includes the dissemination of online resources with other educators and the development of a Cornell Food Venture Center training maintained by Co-I Padilla-Zakour for future fee-based courses. In addition to the food industry participants in our trainings, we have also targeted dissemination of this work to extension educators and managers of farmers markets or shared-use kitchens for participation in this project as these individuals serve important roles in directing small food business owners to food safety resources. Most notably, this included an IAFP symposium titled "Advances in pedagogy, modality, and accessibility for virtual food safety education" which featured a panel of speakers from this project as well as Drs. Shannon Coleman (Iowa State) and Erin DiCaprio (UC Davis) who were collaborators for our trainings with out-of-state partners and who have led their own FSOP projects. This symposium was an opportunity to discuss with fellow food safety educators howadvancements in virtual food safety education occurred rapidly over the last two years as the year 2020 marked a cardinal shift in the proportion of trainings offered online. This change included advantages and challenges for food safety educators, and many of these dynamics will drive future food safety educational opportunities as participants and trainers have adapted to these issues. Distance education offers several opportunities to reach broader audiences, support accessibility and accommodations, and enhance learning outcomes through the use of cutting-edge technologies and approaches. The goal of our symposium was to discuss pedagogy and experiential outcomes associated with virtual food safety education. We discussed pedagogical principles related to application of Bloom's taxonomy, resilient pedagogy theory, and universal design for learning as applied to food safety distance education. We also discussed success strategies related to combination asynchronous and synchronous trainings. Finally, we concluded the session by discussing innovative approaches for fully online food safety curriculum development. What do you plan to do during the next reporting period to accomplish the goals? Nothing Reported

Impacts
What was accomplished under these goals? A total of 2,079 people were trained via asynchronous and synchronous trainings from October 2019 to January 2021. There were 859 synchronous participants in 19 trainings and 1,220 attendees in 4 asynchronous trainings (viewers not just engagements). Food safety experts from 11 different states in the northeastern and midwestern U.S. were involved in the preparation and execution of these food safety training. These states were Maine (1), New York (5), Ohio (2), West Virginia (1), Virginia (2), Georgia (1), Arkansas (1), Missouri and Arkansas (2), Indiana (4), and Wisconsin (4). In most courses, the team of Cornell-based and in-state university trainers were joined by regulators from the state's department of agriculture, sanitarians from the state's department of health, or managers of shared-use kitchens or manufacturing partnership programs (MPP). The content of the training included a range of topics dealing with food safety document development and management. More specifically, our food safety training detailed exemption requirements from the PCHF Rule based on size, GMP requirements, employee training, and the development of different written plans and implementation records. Examples of food safety records (documentation) and templates designed to structure self-determination of documentation requirements were developed. PowerPoint modules were developed in English and Spanish for synchronous delivery and pre-recorded short clips were also provided for asynchronous distribution by the states. The training materials are now freely available on the UVM Clearing House webpage. The structure of the virtual trainings was highly flexible because of the modular format of the training materials. Input from in-state collaborators was used to adapt each training based on individual preferences and needs of the stakeholders. For example, courses have been offered as a series of three 1-hr sessions, as a 2-part series of 90-minute sessions, and as a 1-part 90 minute presentation supplemented with either a roundtable among university food safety specialists and state food safety regulators, a follow-up virtual office hours opportunity, or with a pre-distributed workshop booklet with access to asynchronous materials after the course. After the trainings, surveys and evaluations were performed as recommended by the in-state collaborator. These assessments offered an opportunity for open and optional comments and suggestions. A survey protocol submitted by PI Snyder received exemption from the Institutional Review Board at Cornell University for this data collection. This enabled us to compare outcomes from our in-person trainings from our pilot program (2018-2019) with our virtual trainings offered during the pandemic. For example, one of the most common comments on post-training surveys offered during in-person pilot workshops was that a shorter training would be preferred. The in-person training was 8-hrs in length (including lunch and breaks) which was reduced to 3-hr for virtual trainings. In a post-training survey from a virtual workshop, 94% of respondents indicated that they thought the length was just about right. Additionally, 95.6% of the virtual participants indicated that they had gained knowledge from the training and 92% felt that their expectation had been met. This is a similar level of satisfaction that was reported across the size in-person pilot trainings in which 85.4% of respondents indicated that course was "very useful" and the remaining 14.6% said that the course was "somewhat useful" (Barone, 2020). Qualitative comments were collected from participants. Respondents were asked to identify the most interesting or helpful topic of the training. By far, the most frequent comments indicated that the training, as a whole, was very helpful. Indeed, many different topics were variably identified among different participants, indicating that the integration of different topics was useful. Respondents were also asked what they would change about the training, and the responses that were received were split between stating that the training covered too much new information and stating that the training had too much refresher information. This is indicative of the challenge faced by large group trainings where the previous knowledge and experience of participants is highly variable. When respondents were asked to identify what presentation methods did or did not work well, several key issues important to successful virtual trainings were identified. Respondents were highly appreciative when webinar recordings and slides were posted promptly. Participants responded negatively to poorly functioning audio or delays in slide transitions. This suggests that the need for high-quality, well-rehearsed audio-visual support is required in distance education, and the expectation for strong A-V support on the part of participants is even greater than it might be during in-person trainings. In addition to the multiple versions of the training materials developed for use in our workshops, we have also developed course materials for virtual and/or in-person instruction that will be maintained by the Cornell Food Venture Center for long-term use. These course materials were expanded to include related topics relevant to small food businesses in 6 Modules including: 1) Recognizing the regulatory framework for your business, 2) Microorganisms and their role in food safety, 3) Current Good Manufacturing Practices, 4) Allergen control and food labeling, 5) Food Safety documentation, and 6) What happens next? Each training module is approximately 40 min (virtual, audio over PowerPoint) with closed captioning and targeting an 8thgrade reading level to promote accessibility. Although the development of a revised curriculum for long-term use by the Food Venture Center was a substantial additional undertaking, we determined that it was the best strategy to ensure viability of these materials after the termination of the grant period for this project. Specifically, this will shift to a fee-based course going forward and by having a more comprehensive training that covers broader regulatory frameworks as well as food labeling requirements, small food businesses will be more comfortable paying a fee for participation because this course addresses more of their needs.

Publications

  • Type: Journal Articles Status: Accepted Year Published: 2022 Citation: M.A. Gonzalez Beary, E. DiCaprio, B. Feng, E. Cheng, L. Dunn, O.I. Padilla-Zakour, A.B. Snyder. 2022. Virtual food safety education during the COVID-19 pandemic reveals significant opportunities for future distance learning. Food Safety Management in Practice. Accepted.
  • Type: Conference Papers and Presentations Status: Published Year Published: 2022 Citation: A. Beary* and A.B. Snyder. Technical Symposium. Strategies for the future: Food safety education using resilient pedagogy theory and universal design for learning. Advances in pedagogy, modality, and accessibility for virtual food safety education. International Association for Food Protection (IAFP) Annual Meeting, Pittsburgh, PA. Invited for August 2022.


Progress 09/01/20 to 08/31/21

Outputs
Target Audience:Small food businesses eligible for qualified exemptions from the PCHF Rule of FSMA were the audience who were reached, generally, by the products of this project. However, additionally, the food safety Extension experts who participated collaboratively in these trainings have also been considered as an audience that we have targeted. We developed curriculum materials in a format that appeals to co-instructors and which they can use independently in future years (now shared on the UVM Clearing House website). Our audience was primarily characterized by size because small food businesses represent a specialized audience affected by FSMA. In particular, the needs of value-added specialty product manufacturers differ from those of the broader food system because they are often "very small businesses" operating with extremely limited overhead. Meaning, compliance with food safety regulations can create a significant amount of burden for these businesses to manage even as these programs are essential for ensuring public health. Consequently, small food businesses often rely on communities of support to pool resources in order to comply with regulations and remain sustainable. These resources variably include: shared-use kitchens, where diverse processors rent time in a licensed food manufacturing facility with various equipment infrastructure for manufacture; shared distribution systems such as farm markets which allow for direct marketing and sale of specialty products where advertisement and clientele recruitment efforts are pooled; and use of university Extension resources for training and food safety technical expertise in the form of workshop and education, process authority services, and disbursement of updates and guidance on emerging food safety regulations. Therefore, we targeted small food processors because of their shared specialized needs and relationship to the PCHF Rule will allow for the most effective method of targeting local communities of food processors. Although we did not specify a particular commodity focus, we did receive a lot of engagement from acid/acidified canned foods, fermented foods, and low moisture food producers. Changes/Problems:As for everyone, the challenges posed by the COVID-19 pandemic significantly impacted our ability to offer face-to-face food safety extension training. Because we identified a high demand for this content, rather than delaying implementation of the training, during our last reporting period, we decided to invest time into re-working the training materials so that we could begin offering it under a remote format. In this reporting period, we implemented these distanced education opportunities and identified a high-level of interest and positive evaluations. We decided to see this as an opportunity rather than a limitation because we have been able to reach a wider range of distantly located participants, potentially attracting more participation because travel restrictions were removed, and we have been able to increase accessibility with Spanish language, closed-captioning, and asynchronous access to food safety education. What opportunities for training and professional development has the project provided?The training series based on the adapted content for remote learning is completed. Based on input from our collaborators in each of these states, we offered flexible formatting to address individual preferences and needs. For example, courses have been offered as a series of three 1-hr sessions, as a 2-part series of 90 minute sessions, and as a 1-part 90 minute presentation supplemented with either a roundtable among university food safety specialists and state food safety regulators, a follow-up virtual office hours opportunity, or with a pre-distributed workshop booklet with access to asynchronous materials after the course. Again, the opportunity to pilot the training in Ohio for >200 processors in six sessions in 2018-2019 was an opportunity to learn about what worked and what did not work so that we could be flexible and accommodating among the preferences in different states under the unique remote training environment we now face. We also directed resources to provide Spanish language materials and trainings as a consequence of the opportunity to offer these trainings remotely. We now have presentation materials and pre-recordings in Spanish and are currently offering live Spanish courses in one state, this has been an opportunity to go above and beyond what we initially committed to providing in our grant proposal. These materials have been shared with our collaborators, are posted on our website, and are available through the UVM clearinghouse. We also consider professional development opportunities for the students involved in this project to improve their skills working with industry and in teaching. We have had two students involved in course development and in guest instruction on this course. One of the students is including the scholarly products from her work on this project in her thesis. The other recently received several awards within our department and from external organizations recognizing her involvement in this extension programming. How have the results been disseminated to communities of interest?Again, we have completed 23 trainings in 11 states and >2,000 people have participated in these workshops. We also know that, while collaborators in 11 states were directly involved, we had participants in additional states beyond those 11 participate in workshops, expanding our reach. An abstract for this project was presented at the Northeast Regional Training Centers annual meeting and at the annual Project Directors meeting. We are currently developing a manuscript summarizing our experiences transitioning FSMA add-on content for very small food businesses into a manuscript and are planning to present a technical talk on this topic at IAFP next year. What do you plan to do during the next reporting period to accomplish the goals?In year one, we developed training materials than re-assessed and pivoted to provide distance workshops during the pandemic. We also coordinated with a network of extension specialists in different states, set up regional training sessions, and began offering trainings. In year two, as described in this report, we carried out the majority of trainings, reaching >2,000 processors in 11 states over the course of 23 trainings. In the remaining, final year of the project, we will finish our assessments of these trainings and develop a publication and technical talk. We will also develop the materials into a free-standing, asynchronous online course that will be hosted by Cornell University. These last final activities (evaluation/dissemination of results + online course design) are the primary focus of Year 3.

Impacts
What was accomplished under these goals? A total of 2,079 people were trained via asynchronous and synchronous trainings from October 2019 to January 2021. There were 859 synchronous participants in 19 trainings and 1,220 attendees in 4 asynchronous trainings (viewer's not just engagements). Food safety experts from 11 different states in the northeastern and Midwestern U.S. were involved in the preparation and execution of these food safety training. These states were Maine (1), New York (5), Ohio (2), West Virginia (1), Virginia (2), Georgia (1), Arkansas (1), Missouri and Arkansas (2), Indiana (4), and Wisconsin (4). In most courses, the team of Cornell-based and in-state university trainers were joined by regulators from the state's department of agriculture, sanitarians from the state's department of health, or managers of shared-use kitchens or manufacturing partnership programs (MPP). The content of the training included a range of topics dealing with food safety document development and management. More specifically, our food safety training detailed exemption requirements from the PCHF Rule based on size, GMP requirements, employee training, and the development of different written plans and implementation records. Examples of food safety records (documentation) and templates designed to structure self-determination of documentation requirements were developed. PowerPoint modules were developed in English and Spanish for synchronous delivery and pre-recorded short clips were also provided for asynchronous distribution by the states. The training materials are now freely available on the UVM Clearing House webpage. The structure of the virtual trainings was highly flexible because of the modular format of the training materials. Input from in-state collaborators was used to adapt each training based on individual preferences and needs of the stakeholders. For example, courses have been offered as a series of three 1-hr sessions, as a 2-part series of 90-minute sessions, and as a 1-part 90 minute presentation supplemented with either a roundtable among university food safety specialists and state food safety regulators, a follow-up virtual office hours opportunity, or with a pre-distributed workshop booklet with access to asynchronous materials after the course. After the trainings, surveys and evaluations were performed as recommended by the in-state collaborator. These assessments offered an opportunity for open and optional comments and suggestions. A survey protocol submitted by PI Snyder received exemption from the Institutional Review Board at Cornell University for this data collection. This enabled us to compare outcomes from our in-person trainings from our pilot program (2018-2019) with our virtual trainings offered during the pandemic. For example, one of the most common comments on post-training surveys offered during in-person pilot workshops was that a shorter training would be preferred. The in-person training was 8-hrs in length (including lunch and breaks) which was reduced to 3-hr for virtual trainings. In a post-training survey from a virtual workshop, 94% of respondents indicated that they thought the length was just about right. Additionally, 95.6% of the virtual participants indicated that they had gained knowledge from the training and 92% felt that their expectation had been met. This is a similar level of satisfaction that was reported across the size in-person pilot trainings in which 85.4% of respondents indicated that course was "very useful" and the remaining 14.6% said that the course was "somewhat useful" (Barone, 2020). Qualitative comments were collected from participants. Respondents were asked to identify the most interesting or helpful topic of the training. By far, the most frequent comments indicated that the training, as a whole, was very helpful. Indeed, many different topics were variably identified among different participants, indicating that the integration of different topics was useful. Respondents were also asked what they would change about the training, and the responses that were received were split between stating that the training covered too much new information and stating that the training had too much refresher information. This is indicative of the challenge faced by large group trainings where the previous knowledge and experience of participants is highly variable. When respondents were asked to identify what presentation methods did or did not work well, several key issues important to successful virtual trainings were identified. Respondents were highly appreciative when webinar recording and slides were posted promptly. Participants responded negatively to poorly functioning audio or delays in slide transitions. This suggests that the need for high-quality, well-rehearsed audio-visual support is required in distance education, and the expectation for strong A-V support on the part of participants is even greater than it might be during in-person trainings.

Publications


    Progress 09/01/19 to 08/31/20

    Outputs
    Target Audience:Small food businesses eligible for qualified exemptions from the PCHF Rule of FSMA are the intended audience of the curriculum. However, additionally, the food safety Extension experts who will participate collaboratively in these trainings are also considered an intended audience. We will develop curriculum materials in a format that appeals to co-instructors and which they will use independently in future years. Small food businesses represent a specialized audience affected by FSMA. In particular, the needs of value-added specialty product manufacturers differ from those of the broader food system because they are often "very small businesses" operating with extremely limited overhead producing potentially hazardous foods, some of which are products or businesses additionally subject to the Produce Safety Rule, Acidified Foods Rule, or PMO which can create a significant amount of food safety and regulatory burden for these businesses to manage. Consequently, this group often relies on communities of support to pool resources in order to comply with regulations and remain sustainable. These resources variably include: shared-use kitchens, where diverse processors rent time in a licensed food manufacturing facility with various equipment infrastructure for manufacture; shared distribution systems such as farm markets which allow for direct marketing and sale of specialty products where advertisement and clientele recruitment efforts are pooled; and use of university Extension resources for training and food safety technical expertise in the form of workshop and education, process authority services, and disbursement of updatesand guidance on emerging food safety regulations. Therefore, targeting small food processors because of their shared specialized needs and relationship to the PCHF Rule will allow for the most effective method of targeting local communities of food processors. Changes/Problems:As for everyone, the challenges posed by the COVID-19 pandemic significantly impacted our ability to offer face-to-face food safety extension training. Because we identified a high demand for this content this year, rather than delaying implementation of the training, we decided to invest time into re-working the training materials so that we could begin offering it under a remote format. We decided to see this as an opportunity rather than a limitation because we have been able to reach a wider range of distantly located participants, potentially attracting more participation because travel restrictions were removed, and we have been able to increase accessibility with Spanish language, closed-captioning, and asynchronous access to food safety education. What opportunities for training and professional development has the project provided?The training series based on the adapted content for remote learning is currently underway, having been scheduled for at least 20 sessions in 9 states. Based on input from our collaborators in each of these states, we have offered flexible formatting to address individual preferences and needs. For example, courses have been offered as a series of three 1-hr sessions, as a 2-part series of 90 minute sessions, and as a 1-part 90 minute presentation supplemented with either a roundtable among university food safety specialists and state food safety regulators, a follow-up virtual office hours opportunity, or with a pre-distributed workshop booklet and access to asynchronous materials after the course. Again, the opportunity to pilot the training in Ohio for >200 processorsin 2018-2019 was an opportunity to learn about what worked and what did not work so that we could be flexible and accommodating among the preferences in different states under the unique remote training environment we now face. We also directed resources to provide Spanish language materials and trainings as a consequence of the opportunity to offer these trainings remotely. We now have presentation materials and pre-recordings in Spanish and are currently offering live Spanish courses in one State, this has been an opportunity to go above and beyond what we initially committed to providing in our grant proposal. How have the results been disseminated to communities of interest?Again, we have scheduled 20 trainings in 9 States including closed-captioning and Spanish language access. An abstract for this project was presented at the Northeast Regional Training Centers annual meeting and at the annual Project Directors meeting. What do you plan to do during the next reporting period to accomplish the goals?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. Increase confidence and proficiency among small food processors in document development and FSMA preparedness. Train a network of food safety Extension personnel on the use of the materials developed in this current year. Improve food safety knowledge among small food processors by developing skills in hazard identification specific to their operations. Up to 700 individuals will have participated in this training by the conclusion of the next reporting period. The learning outcomes for this course are: 1) at the conclusion of this workshop, participants will have improved their understanding about the FSMA regulatory requirements specific to their facility and 2) participants will have access to and a command of templates and resources needed to achieve regulatory compliance. We will complete these trainings and summarize the participant data and feedback. We additionally plan to develop a publication on these activities and we will begin developing the permanent online training for this course.

    Impacts
    What was accomplished under these goals? At the start of the project, educational materials were developed to facilitate 3-hr in-person trainings across the country and courses were initially scheduled in several states. After completion of only a fewin-person trainings byearly March, the remaining in-person courses were cancelled for the foreseeable future due to the COVID-19 pandemic. However, stakeholders continued to request training and guidance for qualified exemption-eligible food processors in the development of FSMA documentation throughout Spring, 2020. The increased demand for technical food safety support in this area may have been due to: 1) increased stress on the manufactured food supply chain as consumption decreased in food service; 2) more value-added businesses looked to pivot to address changing consumer demands; and 3) increased availability for remote learning opportunities and professional development under work-from-home restrictions. Recognizing this opportunity to serve an unmet need, we adapted our curriculum to several modular formats for use on-demand by varying collaborating states in the Northeast and Midwest U.S. We were well positioned to adapt our training content to remote learning formats because of our existing experience in piloting the content in 2018 and because we had proposed a shorter overall format and already condensed lessons based on stakeholder feedback from the 2018 pilot series in Ohio. As a consequence, we have been able to schedule and begin offeringtrainings in 9 states.

    Publications