Source: CAROLINA FARM STEWARDSHIP ASSOCIATION submitted to
EMPOWERING SMALL ON FARM AND LIMITED RESOURCE PROCESSORS WITH CUSTOM FSMA TRAINING
Sponsoring Institution
National Institute of Food and Agriculture
Project Status
COMPLETE
Funding Source
Reporting Frequency
Annual
Accession No.
1010524
Grant No.
2016-70020-25789
Cumulative Award Amt.
$58,493.00
Proposal No.
2016-07324
Multistate No.
(N/A)
Project Start Date
Sep 1, 2016
Project End Date
Aug 31, 2018
Grant Year
2016
Program Code
[A4182]- Regional FSMA Center
Project Director
McReynolds, R.
Recipient Organization
CAROLINA FARM STEWARDSHIP ASSOCIATION
287 EAST STREET STE 421
PITTSBORO,NC 27312
Performing Department
(N/A)
Non Technical Summary
The Project will develop and implement a new, high-impact food safety education and outreach program that addresses the needs of small-scale entrepreneurial food processing establishments serving the markets for local and regional foods with low-risk products. The Project will provide a customized food safety training and outreach program that will provide practical, hands-on education on Current Good Manufacturing Pracitces (CGMPs) and FSMA regulations for the thousands of small-scale, diverse farm mixed-type facilities and other establishments producing low-risk value-added foods. Value-added food processing for local and regional food markets is a key business activity for many beginning farmers, limited-resource producers, and food makers using organic, sustainable and conservation-oriented production systems. FDA has identified in its Preventive Controls Rules for Human Food and Animal Feed a long list of low-risk activity/food combinations (LRAFCs) for which preventive controls are not required to minimize the risk of SAHCOD hazards. Small-scale entrepreneurial food processing establishments focused on local and regional food markets commonly limit their value-added production to LRFACs, and these establishments frequently are operated on-farm, out of a home kitchen, or from a shared-used kitchen facility. To address the needs of this audience, the Project collaborators will (1) develop a half-day online training tool specific to prerequisite programs within a GMP complaint facility; (2) develop a one-day hands-on GMP based course for small and very small facilities, including farm mixed type facilities, focusing on risk reduction practices; and (3) pilot delivery of the online tool and in-person course with the target audience; at least half of the participants in the pilot trainings will be limited resource and minority producers. This training option, developed in response to the concerns, and customized to the needs, of this audience will expand CGMP knowledge, understanding, and compliance, and allow these producers to avoid the expense, time investment, and frustration they would otherwise experience participating in training programs focused on preventive controls.
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
71253401010100%
Goals / Objectives
The long-term goal of Empowering Small On Farm and Limited-Resource Processors with Custom FSMA Training is to provide a customized food safety training and outreach program that will meaningfully engage and educate the thousands of small-sale, diverse farm mixed-type facilities and entrepreneurs producing low-risk value-added foods for local and regional markets.The supporting objectives are:develop a half-day online training tool specific to prerequisite programs within a GMP compliant facilitydevelop a one-day hands-on GMP based course for small and very small facilities, including farm mixed type facilities, focusing on risk reduction practicespilot delivery of the online tool and in-person course with the target audience
Project Methods
We will develop a new food safety education and training curriculum for small and very small facilities on CGMPs, including FDA's updates to the CGMPs in the Preventive Controls Rule, that addresses the unique needs of producers of products deemed by FDA to be LRAFCs.Stakeholder Involvement: As described in Sections A and B, the target audiences of small and very small facilities serving local and regional food markets, working with conservation systems, sustainable systems, organic farming systems, and which are currently under-served, such as small-scale producers, tribal producers, socially-disadvantaged and limited-resource producers, and other hard-to-reach audiences, have driven the identification of the need for the propose curriculum. The project partners will form a stakeholder advisory committee comprised of five industry participants, regional extension food safety and agriculture personnel, and state regulators involved with small farmers and processors to provide guidance on project development and deliverables and to assist in evaluation of pilot training results.Proposed Project Activities: The Project will include six stages of activities: (1) Meetings with stakeholder focus groups and advisory committee to assess needs of target audience; (2) Development of content for the half-day pre-requisite program online training module; (3) IT development of online interactive training format; (3) Development of one-day in-person training program; (4) Proof of concept delivery of in-person program and evaluation; (5) Pilot delivery of four full training events with up to 20 participants each: Participants will need to complete the online module prior to participation in the pilot event; and (6) Evaluation.Techniques to be Employed/Evaluation of Outreach and Education Activities/ Analysis of Data: The development and progress of the new CGMP course will be assessed using a logic model that lends itself to planning, updating and measuring knowledge and skill acquisition from existing training programs or modules. The basis of this logic model derives from the cross-functional ability of instructional designers and subject matter experts to assess what works and what doesn't within a program, allowing designers to define the target audience's information needs, and to implement strategies to deliver training materials and collect and analyze feedback from participants. With respect to the new CGMP course, the logic model deals specifically with the program resources, activities, processes, outcomes and impacts needed to successfully assist the target audience to gain necessary knowledge and skills. The Project will meet the key goal of addressing the regulatory needs and challenges of the target audience by combining previous prerequisite and GMP training materials with current FSMA requirements. One clearly identified need is the development of a culturally-appropriate, cost-effective and LRAFC-specific training curriculum that is accessible to the target audience via online and face-to-face activities and that is easy to implement on most small-scale kitchens, commercial kitchens and farm mixed-type facilities. This curricula needs to provide real life scenarios that simulate and reflect LRAFC products manufactured in these facilities. The Management Plan includes a simplified logic model for the new CGMP course that could serve in the initial meeting between PI and Co-PIs in this grant, the industry advisory committee and other stakeholders. Once we have prioritized deliverables for the CGMP courses and category-specific topics, we will build the content of the new courses, taking into consideration the needs and challenges of participants so we can maximize the training and food safety outcomes desired in the context of the target audiences' economic restrictions.The curriculum and training courses will be evaluated using a TOP Model (Rockwell and Bennett, 1975). The TOP Model focuses on both process and outcome indicators, both of which will help guide discussions with the project team regarding progress towards project goals and areas for improvement. In the TOP model approach, once the resources have been allocated to the development of the materials and the KASA (knowledge, attitudes, skills and aspirations) for the target audience has been identified, curriculum developers measure behavioral changes towards the desired direction via pre- and post-test evaluations, challenge questions, and hands-on scenarios during and after training. Hands-on training is among the most effective methods of knowledge retention for adult learners, with participatory training particularly effective for behavior adoption (Eich, 2008).Online resources will use both asynchronous and synchronous delivery mechanisms, with focus on participant engagement and understanding of key concepts. The quantitative component of the evaluation will use a pre- then post-test evaluation (Rossi et al., 2004) to evaluate educational outcomes for the first and second objectives. Pre- then post-test design will measure participants' competencies defined by CGMP, the advisory committee and extension personnel. Additionally, a pre- and post-test evaluation will measure participants' knowledge of the risks associated with LRAFCs and specific to the needs of the target audience manufacturing conditions. For both objectives, follow-up surveys using Qualtrics will be conducted at three and six month intervals to measure participants' adoption and implementation of best practices.

Progress 09/01/16 to 08/31/18

Outputs
Target Audience:Beginning farmers, limited-resource producers, and food makers using organic, sustainable and conservation-oriented production systems were the target audience for our project. Activities conducted during the project included: 1) in-person pre- and post test and online quizzes of members of the target audience to assess their current level of knowledge of Current Good Manufacturing Practices (cGMPs) and applicable Food Safety Modernization Acts (FSMA) Preventive Control Rule regulations for low-risk value-added food processing as defined by the FDA; 2) the development of a half-day online training tool; 3) curriculum development and pilot delivery of formal hands-on cGMP training; and 4) outreach efforts promoting the the program. The activities were marketed to the perceived target audiences throughout North Carolina, South Carolina and Oklahoma. Prior to finalizing the specific subject matter for material development of the online education tools, the target audience was required to complete the FSMA Training Eligibility Form for Small-Scale Food Makers, also utilized to determine their classification as a low-risk value-added food processor as defined by the FDA as well as the population group acknowledging the training need. Population groups included: 69% Beginner Farmers or Ranchers, 25.64% U.S. Veteran or Active Duty Service Members, and 83.33% Limited Resource Farmers or Ranchers. The population group included 56.41% females and 41.03% males. Individuals identified within the population group as Our project advisory committee was instrumental in assisting with the identification of the target audience, as well as reviewing surveys to ensure the content developed meet the needs of the target audience. The project advisory committee included a diverse group of representative from academic institutions, cooperative extension, State Departments of Agriculture and industry agriculture professionals contributing an assortment of education, industry and regulatory knowledge. Every step possible was taken to ensure that participants were provided applicatory subject matter and a systematic approach to food safety requirements under the FSMA Preventive Controls Rule focusing on the required compliance scope, Current Good Manufacturing Practices, with a strong focus on employee training, proper use of monitoring equipment, sanitation practices, development of Standard Operating Procedures (SOPs), recordkeeping requirements and process specific guidance. Changes/Problems:As stated in the previous annual report, the project was delayed due to a project partner experiencing serious health issues. This resulted in a delay in the curriculum development for the DE Modules and Food Safety Modernization Act Good Manufacturing Practices for Making Low-Risk Foods: A Guide for Small-Scale Farms and Food Businesses manual. CFSA recruited an internal staff member who specializes in food safety to assist in the development of the manual content, as well as the DE Module content and design allowing us to complete the project. The advisory committee did not provide as much feedback as we had anticipated, and delayed us for some time waiting on a response once the curriculum was developed and ready for review. Due to delays previously mentioned, it was difficult to finalize dates for pilot delivery of the workshops in North Carolina and Oklahoma, therefore we were not able to market the workshops for the amount time intended, resulting in low participation in both locations. We experienced several technical issues with launching the course on the recommended online delivery platform resulting in delays including: The discount code allowing students to access the course at no charge would not consistently work. Although tested prior to distribution of marketing materials to potential students, the links were not accessible at the time students started registering for the course causing a significant amount of frustration for the students. We found that some students were challenged technologically when attempting to register online for the DE Modules. Students were not consistently prompted to complete quizzes and course evaluations, therefore we do not have conclusive results from all students who completed the course. In reference to #3 above, we believe that part of the confusion was due to the evaluation also being named a 'quiz', which students were prompted to complete prior to closing out the course. The delivery platform only provided the means to upload 'quizzes' and not evaluations. This could potentially be remedied by choosing a platform that offers end of course evaluations or the option to upload an evaluation/survey link such as Survey Monkey. The technical issues referenced above resulted in some folks taking the DE Module prerequisite course, requiring a step-by-step visual tutorial on registering and completing the online portion, provided by instructors of the in-person workshop on the day of delivery. Creating an instructional video may assist with students overcoming the technical challenges. What opportunities for training and professional development has the project provided?Our project developed and pilot tested food safety education and outreach program intended to provide training and professional development for operators of small-scale entrepreneurial food processing establishments serving the markets for local and regional foods with low-risk products. The customized food safety training and outreach program that was developed was provides practical, hands-on education on Current Good Manufacturing Practices (CGMPs) and FSMA regulations for small-scale, diverse farm mixed-type facilities and other establishments producing low-risk value-added foods. The training and professional development program we developed includes: The FSMA Good Manufacturing Practices for Low Risk Foods Distance Education (DE) course. Four Add-On Modules to provide specific recommended GMPs of Low-Risk Food Processing, including blanching, making preserves/jams/jellies/fruit butters, dehydration, and freezing. The in-person FSMA Good Manufacturing Practices for Making Low-Risk Foods Workshop . The FMSA Good Manufacturing Practices for Making Low-Risk Foods: A Guide for Small-Scale Farms and Food Businesses manual, a delivery and take-home resource. The manual is also available to the public on CFSA's website for download in PDF format. During the initial planning stages, 58 small-scale food processors completed the FSMA Training Food Maker Questionnaire in order to identify the product specific cGMP training needs and knowledge level of the target audience. Results indicated that 16 participants were engaged in on-farm food processing activities and therefore may be considered a mixed-type facility by FDA definition. The results of the questionnaire identified 30 entities that were processing food, but did not specifically identify the value-added product as a low-risk food activity combination listed on the questionnaire, but as 'other'. Low risk activities commonly reported included baked goods (excluding cream filled pastries, breads, cookies) (24%), jams, jellies and preserves (28.3%), herb and spice products, including dried herbs/ herbal extracts (18.8%). Based on these results, the add-on modules were developed for blanching, preserves, dehydration, and freezing. Data collected also included the sourcing of raw materials, where 43.4% reported that products were locally sourced from a farm and 44.8% reported that the are not currently registered as an FDA facility. Pertaining to the preferred educational delivery method, 83% preferred face-to-face, 58.3% preferred online learning and 41.6% reported self-learning methods through reading materials. Based on these results, the initial concept of creating a combined delivery method to include an online DE Modules, an in-person GMP course and supplemental reading materials was supported. 55.5% reported that the length of time preferred is a full-day in-person workshop, therefore the workshops were designed for a six to seven hour duration. Online DE Modules: Out of 18 students who completed the GMP DE Module: 11 students completed the quiz without technical difficulty, but required two attempts to meet the minimum required score of 80% to successfully complete the course, where the 1st attempt average score was 61.51% and 2nd attempt average score was 88.45%, demonstrating a 43.80% increased knowledge. 18 participants averaged an 88.45% quiz score, with 100% meeting the minimum score requirement of 80%, including 11 that required a second attempt. 7 participants passed the quiz on the first attempt with an average score of 87.98%. Add-On Modules Preserves, Jams and Jellies DE Module - 6 participants (3 Quiz results - 54.17% averaged (62.5%, 50%, 50%) Blanching DE Module - 5 participants (1 Quiz result - 89.89%) Dehydration DE Module - 5 participants (0 Quiz results) Freezing DE Module - 4 participants (1 Quiz result 70%) In-Person GMP Workshop Increased Knowledge: Pre-Test: 79.8684 Average Post-Test: 89.4736 Average 12.03% Increased Knowledge Change in Behavior: Eighty-six percent of in-person course participants reported that they were very likely to implement changes to their manufacturing practices to comply with cGMPs. One hundred percent of in-person course participants indicated they would recommend the course to others. How have the results been disseminated to communities of interest?In recruiting participants for the course, we reached our target audience in North Carolina through online marketing and event calendars of CFSA and local extension offices where the courses were taught. The target audience in Oklahoma was recruited through the cooperative extension program at Oklahoma State University. Course participation data has been gathered, which included the following: A more user friendly online platform is needed for the target audience. The in-person course content was identified as too dense/detailed by some course participants. 86% of in-person course participants reported that they were very likely to implement changes to their manufacturing practices to comply with cGMPs. 100% of in-person course participants indicated they would recommend the course to others. As this was a pilot project, our plan was to test the effectiveness of the course materials and training program in communicating FSMA cGMP compliance information to small-scale entrepreneurial food processing establishments serving the markets for local and regional foods with low-risk products. As such, we did not anticipate further dissemination of the course and evaluation results, beyond the initial recruitment of course participants, as part of this project. Moreover, due to unavoidable project delays (see below) we were not able to complete the development and pilot testing of the curriculum until August, 2018, leaving very little time for activities to disseminate the products and outcomes during the grant period. However, we have presented information about the program and its results at two meetings organized by the Southern Center for Training, Education, Extension, Outreach and Technical Assistance to Enhance Produce Safety since August, 2018, including the NIFA directors meeting in Blacksburg, VA on August 21. Multiple extension educators who attended those meetings expressed interest in using the curriculum, and we look forward to opportunities to partner with those agencies to disseminate the materials, once the technical difficulties associated with participants' access to the online modules are resolved. What do you plan to do during the next reporting period to accomplish the goals? Nothing Reported

Impacts
What was accomplished under these goals? GOAL #1: The FSMA Good Manufacturing Practices for Low Risk Foods Distance Education (DE) course was developed during the project and delivered to 18 participants. Four Add-On Modules were developed to provide specific recommended GMPs of Low-Risk Food Processing to include blanching, preserves, dehydration, and freezing. GOAL #2: The FSMA Good Manufacturing Practices for Making Low-Risk Foods Course was developed and delivered to 22 participants. The FMSA Good Manufacturing Practices for Making Low-Risk Foods: A Guide for Small-Scale Farms and Food Businesses manual was developed, designed and printed (100 copies) and utilized as a delivery and take-home resource. The manual is also available to the public on CFSA's website (https://www.carolinafarmstewards.org/good-manufacturing-practices-for-low-risk-foods-manual/) for download in PDF format. GOAL #3: The workshops were delivered in the following locations: August 6, 2018 - Greensboro, NC - 9 Participants August 8, 2018 - Stillwater, OK - 9 Participants August 16, 2018 - Mills River, NC - 4 Participants Our project developed and pilot tested food safety education and outreach program intended to address the needs of small-scale entrepreneurial food processing establishments serving the markets for local and regional foods with low-risk products. The customized food safety training and outreach program that was developed was intended to provide practical, hands-on education on Current Good Manufacturing Practices (CGMPs) and FSMA regulations for small-scale, diverse farm mixed-type facilities and other establishments producing low-risk value-added foods. Value-added food processing for local and regional food markets is a key business activity for many beginning farmers, limited-resource producers, and food makers using organic, sustainable and conservation-oriented production systems. FDA has identified in its Preventive Controls Rules for Human Food and Animal Feed a long list of low-risk food/activity combinations (LRFACs) for which preventive controls are not required to minimize the risk of SAHCOD hazards. Small-scale entrepreneurial food processing establishments focused on local and regional food markets commonly limit their value-added production to LRFACs, and these establishments frequently are operated on-farm, out of a home kitchen, or from a shared-used kitchen facility. To address the needs of this audience, we (1) developed a series of online training modules on FSMA's cGMP requirements, and process-specific modules on four low-risk manufacturing processes; (2) develop eda one-day hands-on GMP based course for small and very small facilities, including farm mixed type facilities, focusing on risk reduction practices, including handouts and in-class exercises; and (3) piloted delivery of the online tool and in-person course with the target audience. The results of quizzes on the distance learning module on cGMPs, the pre- and post-tests from people who participated in the three in-person pilot workshops, and those participants' evaluations of the course, indicated a high level of effectiveness and satisfaction with the course materials, validating the usefulness of our proposed approach to create this curriculum that is customized to the needs of the target audience. We saw increases in participant knowledge of cGMPs, and indications that taking the course will contribute to understanding, compliance, and behavioral change on the part of this target audience. Because part of the learning takes place through online training, and because the in-person workshop is only one day long, we are confident that this training program will meaningfully engage and educate the target audience allowing small-scale entrepreneurial food processing establishments serving the markets for local and regional foods with low-risk products avoid the expense, time investment, and frustration they would otherwise experience participating in training programs focused on preventive controls. The in-person workshop created through this project was designed to offer hand-on exercises and demonstrations not currently offered in existing FDA approved Preventive Controls Courses. 11 students completed the cGMP distance learning module quiz without technical difficulty, but required two attempts to meet the minimum required score of 80% to successfully complete the course, where the 1st attempt average score was 61.51% and 2nd attempt average score was 88.45%, demonstrating a 43.80% increased knowledge. 18 participants averaged an 88.45% quiz score, with 100% meeting the minimum score requirement of 80%, including 11 that required a second attempt. 7 participants passed the quiz on the first attempt with an average score of 87.98%. In-person Pilot Workshop - Pre-Test: 79.87 Average, Post-Test: 89.47 Average 86% of in-person workshop participants reported that they were very likely to implement changes to their manufacturing practices to comply with cGMPs. 100% of in-person workshop participants indicated they would recommend the course to others.

Publications


    Progress 09/01/16 to 08/31/17

    Outputs
    Target Audience:Beginning farmers, limited-resource producers, and food makers using organic, sustainable and conservation-oriented production systems are the target audience for our project. In this reporting period we have conducted in-person and online surveys of members of the target audience to assess their current level of knowledge of good manufacturing practices. This knowledge is informing the development of our online training tools and in-person curriculum. Changes/Problems:One of the project Co-PIs experienced significant health issues this year, and this has slowed our progress in developing DEM and in-person curriculum materials. We have adjusted our internal timelines accordingly; however, we remain on track to deliver pilot trainings using these materials in the late winter/early spring of 2018. What opportunities for training and professional development has the project provided? Nothing Reported How have the results been disseminated to communities of interest? Nothing Reported What do you plan to do during the next reporting period to accomplish the goals?Complete development of DEMs and in-person curriculum, and conduct pilot trainings using the DEMs and in-person curriculum in North Carolina and Oklahoma.

    Impacts
    What was accomplished under these goals? The customized food safety training and outreach program we are developing to meaningfully engage and educate the thousands of small-scale, diverse farm mixed-type facilities and entrepreneurs producing low-risk value-added foods for local and regional markets is still under development. As of the close of the reporting period, we had surveyed the target audience and solicited the input of our project advisory committee regarding the material to cover through online education tools, and had identified the specific subjects that will be included in that online portion. Develop a half-day online training tool specific to prerequisite programs within a GMP compliant facility With respect to the half-day online training tool, we have identified a suite of 14 subjects to cover through online distance education modules (DEMs): General GMPs 1. Basics of GMPs in food preservation 2. Basics of microbial pathogens and food safety 3. Labeling Specific processes 4. Blanching 5. Cold and freeze preservation 6. Fermentation 7. Acidified foods (Pickling) 8. Food dehydration 9. Salt preservation 10. Preserves 11. Smoking 12. Home canning 13. Preservation in oil 14. Preservation in alcohol Each module will take an estimated 60 to 90 minutes to complete, and will include a test to measure knowledge acquisition. We expect that we will require participants to complete the General GMP DEMs 1, 2 and 3, and that they will in addition complete the Specific Process DEMs that are relevant to their food manufacturing activities. Develop a one-day hands-on GMP based course for small and very small facilities, including farm mixed type facilities, focusing on risk reduction practices As of the end of the reporting period, development of the in-person training curriculum had not commenced. Pilot delivery of the online tool and in-person course with the target audience Pilot training of the curriculum is scheduled for the late winter/early spring of 2018.

    Publications