Source: UNIVERSITY OF NEBRASKA submitted to NRP
IDENTIFYING FSMA PREVENTIVE CONTROLS TRAINING AND TECHNICAL ASSISTANCE NEEDS OF FOOD MANUFACTURERS IN RURAL NEBRASKA
Sponsoring Institution
National Institute of Food and Agriculture
Project Status
COMPLETE
Funding Source
OTHER GRANTS
Reporting Frequency
Annual
Accession No.
1017270
Grant No.
2018-70020-28855
Cumulative Award Amt.
$70,245.00
Proposal No.
2018-05205
Multistate No.
(N/A)
Project Start Date
Sep 1, 2018
Project End Date
Aug 31, 2020
Grant Year
2018
Program Code
[A4182]- Regional FSMA Center
Recipient Organization
UNIVERSITY OF NEBRASKA
(N/A)
LINCOLN,NE 68583
Performing Department
Food Science and Technology
Non Technical Summary
The goal of this project is to identify food safety preventive controls for human foods training and technical assistance needs of very small food manufacturers in rural Nebraska. Specifically, we want to (1) determine the readiness/preparedness level of very small food manufacturers in rural Nebraska for the successful implementation of the FSMA Preventive Controls for Human Food rule, and (2) establish "mobile food safety clinics" to support the design and implementation of food safety plans as required by current FSMA regulations.Very small food manufacturers located in Central, Northeastern, and Western Nebraska will be selected for participation. Those who decided to participate will receive on-site food safety audits to document the progress towards successful implementation of the preventive controls rule. A survey of company size, needs, and current capabilities will be distributed among very small food manufacturers across rural Nebraska. Mobile food safety clinics will be established in the three selected geographical areas for food safety managers and other stakeholders to attend short trainings and technical assistance sessions on food safety plan development. As part of foundational knowledge expansion, a subset of 10 food safety managers will be invited to participate in an FSPCA preventive controls for human food course in Lincoln, NE with waived registration.The expected short-term outcomes are a better understanding of FMSA readiness levels, an increased awareness of imitations for rural food companies, an increased FMSA knowledge of a rural food manufacturers, and the foundation for the future application to an FSOP Community Outreach Project.
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%
Knowledge Area
712 - Protect Food from Contamination by Pathogenic Microorganisms, Parasites, and Naturally Occurring Toxins;

Subject Of Investigation
5010 - Food;

Field Of Science
1100 - Bacteriology;
Goals / Objectives
The goal of this project is to identify food safety preventive controls for human foods training and technical assistance needs of small and very small food manufacturers in rural Nebraska. Specifically, we want to:Determine the readiness/preparedness level of very small food manufacturers in rural Nebraska for the successful implementation of the FSMA Preventive Controls for Human Food rule, andEstablish "mobile food safety clinics" to support the design and implementation of food safety plans as required by current FSMA regulations.
Project Methods
Facility Selection and RecruitmentThe selection of participating facilities will be done through direct invitation. Listing of food companies will be retrieved from the Nebraska Department of Agriculture, the Nebraska Manufacturing Extension Partnership, and the UNL Food Processing Center. A minimum of 10 and a maximum of 20 very small facilities will be recruited to perform on-site audits for preventive control readiness/preparedness levels. Participation in the study will be voluntary and participants will be instructed of the benefits of participating and how to withdraw if they wish to do so. Facilities that commit to receive at least two on-site audits during the study period will be given priority for recruitment. All food processors in the identified areas that qualify as small facilities will be invited to participate in the mobile food safety clinics. Confidentiality will be maintained during and after the study. The names, addresses, and observations from individual facilities will be kept confidential outside of the senior researchers.To increase basal preventive controls knowledge, 10 food safety managers from small companies will be invited to attend an FSPCA Preventive Controls for Human Foods course in April 2019 in Lincoln, NE organized twice a year by the UNL Food Processing Center. The registration fee will be waived for the invited participants.FSMA Preparedness LevelOnce facilities have been recruited, on-site audits will be conducted using a modified "Food Safety Preventive Control Plan Checklist" developed by Iowa State University Extension (https://www.extension.iastate.edu/grain/files/Migrated/FoodSafetyChecklist_1_17_14.pdf). Scores will be given on 1 to 100 scale, with 100 being the most compliant status. Participating facilities will be audited with the same instrument at least twice during the study period to determine if on-site training and technical assistance have a positive impact on the readiness scores.Mobile Food Safety ClinicsFood safety managers and other workers will be invited to freely attend "mobile food safety clinics" located in Norfolk, Grand Island/Kearney, and Scottsbluff, NE. The purpose of the clinics is to provide on-site, rapid technical advice and interpretation of the regulation following a doctor's appointment model. Facilities that may require further assistance will be visited and attended on-site at a later date. Attendance will be free of charge and will serve to identify technical assistance needs of the local companies and to collect information on the size and type of products manufactured in each region. The clinics will be led by UNL food safety extension specialist with expertise in food regulations, processing, and microbiology.All clinics will be located on UNL extension and research centers or in UNL extension offices as needed. Food safety materials will be readily available in the clinics and technical support will be provided in English and Spanish.

Progress 09/01/18 to 08/31/20

Outputs
Target Audience:The target audience for this project are Nebraska food manufactuerers that must comply with one or more subparts of the Food Safety Modernization Act "Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food" rule, also known as the preventive controls for human food rule. The participants selected in the study were voluntary, and selection did not consider size of the facility or geographical location within the state. Any company that wanted to participate was included because there is an extremely limited number of facilities in the state that must comply with the federal regulation. Facilties that are exempt from all or part of the regulation were also included, if they wanted to participate. Commodities represented in the facilities visited include ready-to-eat meals, spices and blends, and commercial bakery products. The original audience call for rural food manufacturers, but the scope was expanded to food manufacturers anywhere in the state of Nebraska to capture more facilties. Changes/Problems:Major changes: the scope of the project was expanded from rural Nebraska to all Nebraska as we were not able to engage any companies in the rural areas of the state. Major change: we directed efforts towards the development and implementation of environmental monitoring programs in small and very small RTE food facilities, which was the main deficiency we identified during visits and assessments. Major problems: Visits have been delayed and/or canceled because of the 2019 Nebraska flooding disaster and the 2020 What opportunities for training and professional development has the project provided?Based on the results and observations from this project, we will direct some of our future efforts to four main areas: -Good manufacturing practices -Food safety and emergency preparedness -Intentional Adulteration FSMA rule -Environmental monitoring for small and very small processors How have the results been disseminated to communities of interest?COMPANIES: Faciltiy reports with results of observations and assessments as well phone calls, emails, an in-person explanation of results. SCIENTIFIC COMMUNITY: Peer-review publications in preparation. What do you plan to do during the next reporting period to accomplish the goals? Nothing Reported

Impacts
What was accomplished under these goals? Under objective 1, we were able to identify and engage facilities to conduct FSMA readiness and preparedness assessments on site. A total of seven facilities were visited at least once and in-person walk-throughs and interviews with food safety and quality personnel allowed for the completion of the assessments. From these facilities, employees were sent to take our FSMA PCHF rule course at UNL and several on-site trainings on GMPs were provided. The results of the assessments are in the process of being published and additional training needs will be identified that can be tackled in the near future. The one area of FSMA were all facilities were lacking was environmental monitoring. Therefore, a project re-scope was submmitted and granted by NIFA in early 2020 that allowed us to dedicate funds to conducting environmental monitoring assessments in RTE food facilities in Nebraska. A total of three facilties that opened their doors to the project were visited three times each and samples were collected and analyzed for Listeria and L. monocytogenes. Additionally, the facilties were mapped to contribute to the development of their own environmental monitoring program that will help them be compliant with FSMA. The results are also in the process of being published and individual facilty visit reports are sent and discussed with each facillity. Objective 2 was not attainable because we could not identify rural facilities willing to use the clinics, and in reality, there are very few, if any faciltiies in rural Nebraska that need to comply with this FSMA rule. We expanded the scope to all the state and we directed the resources to individual on-site visits and assessments.

Publications

  • Type: Journal Articles Status: Other Year Published: 2021 Citation: Chaves, B.D. and B. Martinez, T. Howell. Assessment of Nebraska food manufacturers compliance with FSMA preventive control for human foods via checklist and facility visits. IN PREPARATION.
  • Type: Journal Articles Status: Other Year Published: 2021 Citation: Chaves, B.D., Cano, C., B. Martinez, T. Howell. Nebraska food manufacturers self-reported progress towards compliance with the FSMA Preventive Controls for Human Food rule. IN PREPARATION.
  • Type: Journal Articles Status: Other Year Published: 2021 Citation: Etaka, C.A., B. Martinez, C. Cano, and B.D. Chaves*. Prevalence and mapping of Listeria spp. and Listeria monocytogenes in small and very small ready-to-eat food facilities in Nebraska. IN PREPARATION.


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

Outputs
Target Audience:The target audience for this project are Nebraska food manufactuerers that must comply with one or more subparts of the Food Safety Modernization Act "Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food" rule, also known as the preventive controls for human food rule. The participants selected in the study were voluntary, and selection did not consider size of the facility or geographical location within the state. Any company that wanted to participate was included because there is an extremely limited number of facilities in the state that must comply with the federal regulation. Facilties that are exempt from all or part of the regulation were also included, if they wanted to participate. Commodities represented in the facilities visited include ready-to-eat meals, spices and blends, and commercial bakery products. The original audience call for rural food manufacturers, but the scope was expanded to food manufacturers anywhere in the state of Nebraska to capture more facilties. Changes/Problems:Major changes: the scope of the project was expanded from rural Nebraska to all Nebraska as we were not able to engage any companies in the rural areas of the state. Major change: we directed efforts towards the development and implementation of environmental monitoring programs in small and very small RTE food facilities, which was the main deficiency we identified during visits and assessments. Major problems: Visits have been delayed and/or canceled because of the 2019 Nebraska flooding disaster and the 2020 covid-19 epidemic. The shutdown of the university meant some of the funding went unspent and facility visits and sample collection was delayed by over 4 months. What opportunities for training and professional development has the project provided?Based on the results and observations from this project, we will direct some of our future efforts to fourmain areas: -Good manufacturing practices -Food safety and emergency preparedness -Intentional Adulteration FSMA rule -Environmental monitoring for small and very small processors How have the results been disseminated to communities of interest?COMPANIES: Faciltiy reports with results of observations and assessments as well phone calls, emails, an in-person explanation of results. SCIENTIFIC COMMUNITY: Peer-review publications in preparation. What do you plan to do during the next reporting period to accomplish the goals? Nothing Reported

Impacts
What was accomplished under these goals? Under objective 1, we were able to identify and engage facilities to conduct FSMA readiness and preparedness assessments on site. A total of seven facilities were visited at least once and in-person walk-throughs and interviews with food safety and quality personnel allowed for the completion of the assessments. From these facilities, employees were sent to take our FSMA PCHF rule course at UNL and several on-site trainings on GMPs were provided. The results of the assessments are in the process of being published and additional training needs will be identified that can be tackled in the near future. The one area of FSMA were all facilities were lacking was environmental monitoring. Therefore, a project re-scope was submmitted and granted by NIFA in early 2020 that allowed us to dedicate funds to conducting environmental monitoring assessments in RTE food facilities in Nebraska. A total of three facilties that opened their doors to the project were visited three times each and samples were collected and analyzed for Listeria and L. monocytogenes. Additionally, the facilties were mapped to contribute to the development of their own environmental monitoring program that will help them be compliant with FSMA. The results are also in the process of being published and individual facilty visit reports are sent and discussed with each facillity. Objective 2 was not attainable because we could not identify rural facilities willing to use the clinics, and in reality, there are very few, if any faciltiies in rural Nebraska that need to comply with this FSMA rule. We expanded the scope to all the state and we directed the resources to individual on-site visits and assessments.

Publications

  • Type: Journal Articles Status: Other Year Published: 2021 Citation: Chaves, B.D. and B. Martinez, T. Howell. Assessment of Nebraska food manufacturers compliance with FSMA preventive control for human foods via checklist and facility visits. IN PREPARATION.
  • Type: Journal Articles Status: Other Year Published: 2021 Citation: Chaves, B.D., Cano, C., B. Martinez, T. Howell. Nebraska food manufacturers self-reported progress towards compliance with the FSMA Preventive Controls for Human Food rule. IN PREPARATION.
  • Type: Journal Articles Status: Other Year Published: 2021 Citation: Etaka, C.A., B. Martinez, C. Cano, and B.D. Chaves*. Prevalence and mapping of Listeria spp. and Listeria monocytogenes in small and very small ready-to-eat food facilities in Nebraska. IN PREPARATION.


Progress 09/01/18 to 08/31/19

Outputs
Target Audience:The target audience for this project are Nebraska food manufactuerers that must comply with one or more subparts of the Food Safety Modernization Act "Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food" rule, also known as the preventive controls for human food rule. The participants selected in the study were voluntary, and selection did not consider size of the facility or geographical location within the state. Any company that wanted to participate was included because there is an extremely limited number of facilities in the state that must comply with the federal regulation. Facilties that are exempt from all or part of the regulation were also included, if they wanted to participate. Commodities represented in the facilities visited include ready-to-eat meals, spices and blends, and commercial bakery products. The original audience call for rural food manufacturers, but the scope was expanded to food manufacturers anywhere in the state of Nebraska to capture more facilties. Changes/Problems:Major changes: the scope of the project was expanded from rural Nebraska to all Nebraska as we were not able to engage any companies in the rural areas of the state. Major problems: Visits have been delayed and/or canceled because of the 2019 Nebraska flooding disaster and the 2020 covid-19 epidemic. What opportunities for training and professional development has the project provided?The most notable needs for training are (1) good manufacturing practices and (2) environmental monitoring program. The first one is being covered under this project with an 8-hour, in-person GMP course. The second one will be covered by another USDA-NIFA-FSOP grant awarded to PD Chaves. The most notable needs for professional development is (1) for the PD to get trained in intentional adulteration rule, which the FDA is now rolling out, as there have been several questions during the facility visits, (2) for the PD to get more structured training in risk communication. How have the results been disseminated to communities of interest?Results are company-specific and delivered confidentially via email. Overall, anonymized results have been shared in the 2019 North Central Regional FSMA meeting and were going to be updated in the 2020 meeting, now cancelled. A publication is still expected to be completed. What do you plan to do during the next reporting period to accomplish the goals?-Continue to visit food facilities to determine any changes in compliance over time. -Create reports with suggestions and recommendation for industry to improve their food safety system. -Survey the food industry in self-reported compliance with FSMA.

Impacts
What was accomplished under these goals? - Training of 10 small/very small industry workers in the Preventive Controls for Human Food course taught at UNL under the Food Safety Preventive Controls Alliance standardized curriculum. - Visiting 10 facilities to assess compliance levels with the PCHF rule, and retaining 7 of those faciltiies for successive visits. - Establishing additional extension collaborations and partnerships with industry. We are in the process of helping very small companies that produce ready-to-eat foods to design and implement their environmental monitoring program.

Publications