Source: UNIVERSITY OF NEBRASKA submitted to NRP
IMPROVING THE DEVELOPMENT OF FOOD SAFETY PLANS THROUGH THE ADVANCED PREVENTIVE CONTROLS SCHOOL INITIATIVE
Sponsoring Institution
National Institute of Food and Agriculture
Project Status
COMPLETE
Funding Source
Reporting Frequency
Annual
Accession No.
1020747
Grant No.
2019-70020-30340
Cumulative Award Amt.
$299,559.00
Proposal No.
2019-04205
Multistate No.
(N/A)
Project Start Date
Sep 1, 2019
Project End Date
Aug 31, 2023
Grant Year
2019
Program Code
[A4182]- Regional FSMA Center
Recipient Organization
UNIVERSITY OF NEBRASKA
(N/A)
LINCOLN,NE 68583
Performing Department
Food Science and Nutrition
Non Technical Summary
In order to successfully design and execute an effective food safety plan, food manufacturers require continuous training beyond the foundational PCQI course. Therefore, the long-term goal of this project is to help increase FSMA regulatory compliance of small and very small facilities by building their capacity to develop and implement adequate food safety plans. Specifically, we propose to: 1) Develop an advanced preventive controls for human food training curriculum; 2) Implement the "advanced preventive controls school" training initiative in Nebraska, Guam, and Puerto Rico; 3) Measure the impact of advanced training on the participants' FSMA PCHF foundational knowledge, attitudes, practices, and ability to develop and implement a food safety plan; and 4) Identify future training needs of food manufacturers in the U.S. Central Plain Region, Guam, and Puerto Rico. We have put together a team of food safety experts to elaborate and expand curricula on hazard analysis and risk assessment, validation of process preventive controls, effective food allergen management, and environmental monitoring programs. The advanced training will be taught in Nebraska, Guam, and Puerto Rico, where impact on participant knowledge, attitudes, and FSMA PCHF practices will be assessed via structured surveys. Additionally, the small and very small food manufacturers in the selected regions will be surveyed for additional training needs.The proposed project makes meaningful contributions to the food safety training of small and very small manufacturers in the US. Central Plains region as well as in US. insular areas, and establishes significant collaborations with Guam and Puerto Rico.
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
71250101100100%
Goals / Objectives
The long-term goal of this project is to increase FSMA regulatory compliance of small and very small facilities by building their capacity to develop and implement adequate food safety plans. A "Preventive Controls School" approach will be used in which course participants will gain in-depth knowledge of risk-based hazard analysis as well as process, sanitation, and food allergen preventive controls, thus providing an additional layer of training beyond the PCQI course.There are four objectives under this project. Objectives (1) and (2) focus on curriculum expansion, development, and implementation via an "Advanced Preventive Controls School" approach. Objectives (3) and (4) will allow the team to measure the impact of the new curriculum and determine future training needs of the participants. Specifically, we propose to:Develop an advanced preventive controls for human food training curriculum;Implement the "advanced preventive controls school" training initiative in Nebraska, Guam, and Puerto Rico;Measure the impact of advanced training on the participants' FSMA PCHF foundational knowledge, attitudes, practices, and ability to develop and implement a food safety plan; andIdentify future training needs of food manufacturers in the U.S. Central Plain Region, Guam, and Puerto Rico.
Project Methods
Curriculum expansion and developmentazard Analysis and Risk Assessment. The participants will learn principles of statistical process control and risk assessment applied to food safety. This will enhance their ability to conduct a hazard analysis and interpret microbiological results in their facilities. The curriculum will be created based on the "Microorganisms in Foods" series by the International Commission on Microbiological Specifications for Foods (ICMSF) as well as risk assessment guidelines from FAO/WHO, FDA, USDA-FSIS, and EPA. Potential applications in daily risk management practices will be demonstrated through several well recognized risk-based analysis and decision-making tools. Risk Ranger is a simple food safety risk calculator for aiding in the relative risk estimation at different product, pathogen, and processing combinations. iRISK is as a more advanced quantitative risk calculator allowing for the consideration of processing conditions and various predictive microbiology tools by ComBase.Process Controls. The participants will learn the fundamental of product and process validation. This will provide tools to conduct in-plant validations and interpret published literature. The foundations for this portion of the course will be taken from FDA guidance documents, NACMCF (2010) "Parameters for Determining Inoculated Pack/Challenge Study Protocols", and other peer-reviewed materials. Focus will be on the use, selection, and interpretation of microbiological results: pathogens, surrogates, and indicators. Furthermore, attention will be placed on the factors that interact to determine microbiological reductions (pH, water activity, fat content, etc.) with clear examples from published scientific data. The use of microbiological predictive models as a validation tool will be addressed along with experimental validation. Lastly, statistical aspects of validations will be covered, including experimental design, sampling size determination, and data interpretation.Food Allergen Controls. Effective food allergen management requires the implementation of multi-faceted programs to prevent the presence of undeclared allergens in packaged foods. In addition to using FDA guidance that is or will be available, the FARRP faculty specialists (Drs. Downs and Baumert) will develop an appropriate food allergen control curriculum by drawing on their experience developing and delivering food allergen management training programs and their knowledge of food industry best practices. The Food Allergen Controls curriculum will provide practical guidance for developing a holistic allergen control program, focusing on the following areas: (1) How to identify food allergen hazards: common and unexpected sources of food allergens (including supply chain controls); (2) How to properly label food allergens: regulatory requirements and labeling controls; (3) How to prevent cross-contact in production facilities: receiving, storage, handling, scheduling, and cleaning practices and procedures; and (4) ow to determine the effectiveness of food allergen controls.Environmental Monitoring Programs. The purpose of this module is to introduce participants to the control of Salmonella and Listeria in their operation environment. The content will focus on facility mapping and zoning; seek-and-destroy approach to identifying of niches and sources of contamination, including persistent pathogens and biofilms; effective sanitary practices including chemical, physical, and biocontrol methods. Lastly, the course will teach participants about sampling techniques and sampling size, including the use of commercially available software for environmental monitoring programs.Course implementationLocationThe course will be delivered twice each in Nebraska (Omaha or Lincoln), Guam, and Puerto Rico during the life of the project. The first delivery will serve as the pilot course to guide modifications to the curriculum.Target Audience/Selection and RecruitmentThe direct target audience for this project is small and very small food manufacturers that need to comply with FSMA PCHF rule and therefore require to write and execute a food safety plan. The Nebraska course will target the increasing regional food processing operations. Collaborations with insular areas will ensure the content is delivered to the local industry in the corresponding location. Additional to food industry, the course will target state/territory food inspectors, extension agents/educators, and local faculty and students. The pre-requisite to participate in the course is to be a PCQI. Facility selection and invitation will be performed electronically and via phone through listservs of the Nebraska Department of Agriculture, the UNL Food Processing Center, and the Nebraska Manufacturing Extension Partnership. The latter will collaborate with passing the information to regional MEP in neighboring states to make them aware and invite them to participate in the course. Each course session in Nebraska will target 30 participants from across the regional food industry. In Guam and Puerto Rico, recruitment will be performed directly through our local points of contact. The insular collaborators will provide logistics support for site selection, printing of materials, and intensive recruitment.The course is also open to importers that need to comply with Foreign Supplier Verification programs regulations and that want additional training. Future training modules, online or in person, will also target small foreign facilities that need to comply with PCFH.Format and DeliveryThe course will be taught in-person using a lecture-based method with examples, case studies, and group activities. When needed, pertinent software will be included in the exercises to introduce the participants to the tools in each module. All the printed materials will be provided to the participants. There are two modalities for the initiative based on location:Nebraska. The "advanced preventive controls school" will be taught in three separate courses:Principles of Hazard Analysis and Risk Assessment for the Food Industry (1.5 days; Drs. Chaves and Wang)Microbiological and Challenge Studies for the Food Industry (1.5 days; Drs. Chaves and Martinez)Food Allergen Control and Environmental Sanitation (2 days; Dr. Chaves, Baumert, Downs, and Martinez)Guam and Puerto Rico. The course will be taught as a one-week long training module in the sequence detailed above. Participants in the continental US course will receive a certificate of attendance at the end of each module they complete, and participants in insular areas must complete the entire course to receive a certificate of training. The total contact time for the full course is 40 hours. Each project team member will be in charge of teaching and leading specific sections of the courses based on their area of expertise. The graduate student engaged in the project will be invited to teach portions of the curriculum to help develop her oral communication skills.

Progress 09/01/19 to 08/31/23

Outputs
Target Audience:The direct target audience for this project is small and very small food manufacturers that need to comply with FSMA PCHF rule and therefore require to write and execute a food safety plan. We targeted Nebraska regional companies as well as operations in Guam and Puerto Rico. Additional to food industry, the course content was received by state/territory food inspectors, extensionagents/educators, and local faculty and students. The pre-requisite to participate in the course is to be a PCQI, but this did not always happen and the modules served as an introduction to food safety by many industry practiotioner. Changes/Problems:COVID was the main problem, but we managed to effectively use the funds by reducing some of the traveling and rather bringing interns to Nebraska from the two insular areas (2 from Guam and 3 from Puerto Rico). I am grateful to NIFA for the flexibility. What opportunities for training and professional development has the project provided?Five interns came to Nebraska and had the opportunity to learn food safety extension. For the PIs, I would say that visiting Guam and Puerto Rico for the first time and delivering training there was an enriching experience. How have the results been disseminated to communities of interest?Yes, to some extent. PI Chaves is still working on this. We delivered training in Puerto Rico, Guam, and across the midwest. What do you plan to do during the next reporting period to accomplish the goals? Nothing Reported

Impacts
What was accomplished under these goals? For the advanced preventive controls schools, we developed and delivered modules in environmental monitoring, hazard analysis and risks assessment, and allergen management. We did not deliver content on product/process validations because we did not find the right audience for it. Two trips from Nebraska to Guam and two trips from Nebraska to Puerto Rico were extremely enriching with networking, understanding cultural differences in food production as well as challenges and opportunities for future grants. Five total interns from US insular areas came to Nebraska to learn food safety and work on extension projects. This was a highlight of this project. Future training needs - we are still working on this. For Guam, a survey is being developed.

Publications


    Progress 09/01/21 to 08/31/22

    Outputs
    Target Audience: Nothing Reported Changes/Problems: Nothing Reported What opportunities for training and professional development has the project provided? Nothing Reported How have the results been disseminated to communities of interest?Yes, in Nebraska and the US North Central Region What do you plan to do during the next reporting period to accomplish the goals?Dissemination in Puerto Rico (December 7 through 14, 2022) Dissemination in Guam (January 5 through 12, 2023) Continue virtual and in-person courses in Nebraska.

    Impacts
    What was accomplished under these goals? Training curricula in hazard analysis and risk assessment as well as environmental monitoring

    Publications


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

      Outputs
      Target Audience:The direct target audience for this project is small and very small food manufacturers that need to comply with FSMA PCHF rule and therefore require to write and execute a food safety plan. The Nebraska course will target the increasing regional food processing operations. Collaborations with insular areas will ensure the content is delivered to the local industry in the corresponding location. Additional to food industry, the course will target state/territory food inspectors, extensionagents/educators, and local faculty and students. The pre-requisite to participate in the course is to be a PCQI. Facility selection and invitation will be performed electronically and via phone through listservs of the Nebraska Department of Agriculture, the UNL Food Processing Center, and the Nebraska Manufacturing Extension Partnership. The latter will collaborate with passing the information to regional MEP in neighboring states to make them aware and invite them to participate in the course. Each course session in Nebraska will target 30 participants from across the regional food industry. In Guam and Puerto Rico, recruitment will be performed directly through our local points of contact. The insular collaborators will provide logistics support for site selection, printing of materials, and intensive recruitment. The course is also open to importers that need to comply with Foreign Supplier Verification programs regulations and that want additional training. Future training modules, online or in person, will also target small foreign facilities that need to comply with PCFH. Changes/Problems:The largest problem and challenge we face is that the covid-19 pandemic hasn't really subsided, even with vaccination rates increasing. Domestic travel continues to be challenging and in-person gatherings are still restricted in many regions/states. The project team really wants to deliver the trainings in person, for several reasons: direct contact with participants, opportunities to visit food companies in Guam and Puerto Rico, and potential interviews/recruitment of insular area studnets to come to Nebraska as interns or graduate students in the near future. A consequence of the pandemic and the difficulty to travel is that we have not spent a large proportion of the funds assigned to the project for travel, which represent a large proportion of the budget. Team efforts are underway to determine best use of funds and communicate with NIFA for approval. What opportunities for training and professional development has the project provided?- Multiple fundational programs have been offered to put the food industry on the same page, including GMP and HACCP training. 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?We are still interested in providing these courses in person in Nebraska and insular areas. We are hoping that summer 2022 we can do this. In the meantime, some materials are being digitalized (videos, short recordings, etc) to provide to industry.

      Impacts
      What was accomplished under these goals? - Expanded network to include the Puerto Rico Manufacturing Extension Partnership. This agency will collaborate on recruitment of food wokers for online or in-person future trainings. - One intern from Puerto Rico is at the University of Nebraska working under this project. Recruitment for two other interns is underway to start in spring 2022. - A bilingual undergraduate student is being hired under this project to produce food safety training videos in Spanish.

      Publications


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

        Outputs
        Target Audience:The direct target audience for this project is small and very small food manufacturers that need to comply with FSMA PCHF rule and therefore require to write and execute a food safety plan. The Nebraska course will target the increasing regional food processing operations. Collaborations with insular areas will ensure the content is delivered to the local industry in the corresponding location. Additional to food industry, the course will target state/territory food inspectors, extension agents/educators, and local faculty and students. The pre-requisite to participate in the course is to be a PCQI. Changes/Problems:The covid-19 pandemic has not allowed us to travel anywhere for content delivery. While we are in the process of developing the content and turning some of that into online/virtual educational materials such as recorded lectures, videos, webinars, and others, we truly believe in the power of in-person training to engage the food industry and develop connections. We are hoping to get an extension at no cost that will allow us to travel later in 2021 and in 2022 to deliver the materials in Guam and Puerto Rico. Much of the global food industry is in crises mode right now and recruitment of participants for any type of course has been extremely challenging. We believe that delivering the material in 2021 and 2022 will allow us to be more successful and impactful with our recruitment. 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?Finalize curricula. Deliver the course in modules for Puerto Rico and Guam Potential in-person delivery of the course in Nebraska Development of assessment surveys for the course.

        Impacts
        What was accomplished under these goals? The major accomplishment so far in this project is the development of curricula in the specified areas that we are targeting: risk assessment and hazard analysis, environmental monitoring, allergen management and sanitation. Additionally, the project includes an FDA/OSHA survey on the impact of covid-19 and food safety. We are working on admininstering this survey. Implementation of the program, whether in person or remotely, is on hold for now while we navigate the challenges of the covid-19 pandemic while still creating engaging and relevant materials.

        Publications