Source: N Y AGRICULTURAL EXPT STATION submitted to NRP
FOOD SAFETY FOR QUALIFIED EXEMPT FOOD PRODUCERS TO BUILD ECONOMIC VIABILITY UNDER THE FOOD SAFETY MODERNIZATION ACT
Sponsoring Institution
National Institute of Food and Agriculture
Project Status
COMPLETE
Funding Source
Reporting Frequency
Annual
Accession No.
1017351
Grant No.
2018-70020-28854
Cumulative Award Amt.
$74,999.00
Proposal No.
2018-05195
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
N Y AGRICULTURAL EXPT STATION
(N/A)
GENEVA,NY 14456
Performing Department
Food Science
Non Technical Summary
Although Small and Very Small Manufacturers are qualified to be exempt from parts of the Food Safety Modernization Act (FSMA), these facilities are still required to follow the Current Good Manufacturing Practices as well as FSMA-specific requirements for record keeping and training of personnel. Attestation that shows a manufacturer to be qualified for exemption is also necessary and must document the basic evaluation of potential hazards associated with the foods produced. In order to help small food producers to comply with the newly introduced requirements, this proposal aims to create a program that will provide adequate support and training to ensure that qualified exempt companies are ready to achieve regulatory compliance. The program will include the identification of specific training and documentation needs; development and delivery of training in principles of Food Safety and Safe Preservation of Foods, cGMPs, Reduced Oxygen Packaging totally approximately 24 h of training hours to at least 50 qualified exempt producers from local urban and rural communities. This project will be built upon existing training programs and previous experience by the Cornell Food Venture Center, which provides product and process safety evaluations for approximately 500 small food entrepreneurs annually. We expect that this proposal will show that the program can help small scale food producers to achieve regulatory compliance and positively contribute to the long term financial success of these businesses, so that this effort can be expanded and replicated in the future.
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 Food Safety Modernization Act (FSMA), passed into law on January 4, 2011, is the first 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 qualified to be exempt from parts of the rule, notably the need for a formal Hazard Analysis and Preventive Control Plan, these facilities are still required to follow the Current Good Manufacturing Practices as well as FSMA-specific requirements for record keeping and training of personnel. Attestation that shows a manufacturer to be qualified for exemption is necessary, including proper documentation demonstrating the company to be a small or very small business following the economic parameters enforced in the Act. Additionally, the manufacturer must also provide an attestation that the manufacturer has evaluated potential hazards associated with the foods produced and implemented record keeping and training activities related to these hazards. An alternative to this second requirement may be documentation showing the manufacturer to be under applicable non-Federal food safety regulations. Even though there are still questions regarding the details of how the regulation will be applied to these manufacturers and the requirements for local regulation to be deemed sufficient, there are clear and immediate needs that must be covered to ensure that qualified manufacturers are both compliant to FSMA requirements and are using processing conditions that ensure manufacturing of safe food, in accordance to the objectives of the Act. Therefore, the objectives of this project are to:i) Identify specific training needs of qualified exempt food producers to meet regulatory requirements, including exemption attestation under FSMA;ii) Develop and deliver training in principles of Food Safety including cGMPs to at least 50 qualified exempt producers in local urban and rural communities;iii) Conduct process evaluation and establish preventive control guidelines per food categories for regulatory record compliance by qualified exempt food producers.
Project Methods
To accomplish the project objectives, the following steps will be conducted:1. Review of updating needs for Reduced Oxygen Packaging Course and the cGMPs training.2. Outlining the Principles of Food Microbiology and Principles of Safe Food Preservation for Entrepreneurs courses.3. Review of regulatory requirements and guidance for qualified exemption for small and very small manufacturers.4. Course Development, creation of teaching materials.5. Perform initial survey for qualified food producers, determination of qualification status6. Conduct pilot training evaluation and review. Determine training dates, location and classes.7. Conduct in-person training classes. Delivery of product group process reviews and guidance for record-keeping compliance.8. Survey data evaluation. Global review with stakeholders. Final report writing.

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

Outputs
Target Audience:During this reporting period, the Cornell Food Venture Center's efforts reached a diversified audience of regional small food manufacturers and Extension educators when conducting the pilot training of "Food Safety for Qualified Exempt Food Producers to Build Economic Viability Under the Food Safety Modernization Act" Program. Our primary goal for this outreach program is to connect with regional food manufacturers who could be classified as "Qualified Exempt Facilities" under FSMA regulations and share with them a well-rounded training that covered general food safety practices, safe food preservation, safety guidelines for specific processing and packaging methods and the information needed in order to comply with the recent changes in federal rules. Small and Very Small food processors would fall under the "Qualified Facilities" categories. In the region within the local program catchment area, small food processors are culturally diverse including Amish/Mennonite businesses as well as underserved urban entrepreneurs in Rochester, NY. Each of these communities require different outreach strategies in order to alert them to important trainings available in their region. For example, much of the New York Amish and Mennonite population do not have access to computers or the internet, nor do they desire this technology due to their cultural and religious beliefs. To frame the marketing materials for the target audience and plan for the most accessible training site, we consulted with Judson Reid, Vegetable Specialist with Yates County Cornell Cooperative Extension, who works closely with Amish and Mennonite communities in the region. We also consulted with Laura Fox, Vice President of Rochester Downtown Development Corporation and President of The Commissary Incubator Kitchen, for feedback on reaching and training small urban food processors, many of whom work other full-time jobs while trying to launch their own small food-centered business. Outreach strategies included email blasts to small food manufacturers who work with the Cornell Food Venture Center (CFVC) and The Commissary, online event registration, shared event postings with NECAFS (Northeast Center to Advance Food Safety), the Institute for Food Safety at Cornell University, and the Center of Excellence for Food and Agriculture. Printed flyers were posted and distributed at local produce auction sites, New York Vegetable Growers meetings, the Grow-NY Conference, Northeast Organic Farming Association (NOFA) - NY Conference, and plain-sect community retail food outlets. To reach a wider population, we employed the help of six different Cornell Cooperative Extension offices as well as Cornell's Small Farms Program to share the event within their networks. Various forms of multimedia were also employed to publicize the training events to targeted audiences. These included an interview with course instructor, Cynthia James, in the Rochester Business Journal (both print and online versions); an ad block in The Torch, a bi-weekly newsletter distributed throughout local Amish/Mennonite communities; postings in local Community Calendars (NPR WEOS and Finger Lakes Times); Facebook postings on both the Cornell AgriTech page and Cornell Food Venture Center's page; and NECAFS included the event in their regular newsletter that went out through their email listserv. The CFVC targeted small processors by emailing an announcement for the event to businesses who had already employed the center's services for their products. In January of 2020, the CFVC conducted two 8-hour trainings at two separate locations to best reach the two distinct target audiences. One training was hosted at Cornell AgriTech in Geneva, NY, which is located equidistant between two major plain-sect communities located on opposite shores of Seneca Lake, in an effort to make the event accessible to the largest number of participants from these communities; out of the two Geneva trainings (October 2019 & January 2020), 4 participants were from plain-sect communities. The second January training was held at RIT Center for Urban Entrepreneurship in Rochester, NY in conjunction with The Commissary's membership network and staff. The trainings were attended by a total audience of 74 people during this reporting period (40 participants in Rochester and 34 participants in Geneva). The majority of attendees was comprised of small food manufacturers from diversified backgrounds including both urban entrepreneurs and processors from Amish/Mennonite heritage. The Rochester training was filled with a majority of participants from the urban center of Rochester and the regions directly adjacent to the city. Attendees included a mix of small commercial processors and people with businesses operating under the Home Processor's exemption in NYS. The Geneva training was populated with a diverse audience that included some Amish/Mennonite participants, Cornell Cooperative Extension (CCE) educators, and other small food processors. The CCE educators were a welcome surprise to the course audience; their goal was to gain knowledge so that they could then train small processors within their service regions, further expanding the reach of the course. As a result of the training, CFVC has received several requests to hold a version of the course at different Cooperative Extension offices throughout the state. Changes/Problems: Nothing Reported What opportunities for training and professional development has the project provided?The project has provided training opportunities for small and very small food processors to understand both how to produce a safe food product and the related regulatory guidelines that they must comply with at a local, state and federal level. This information will ultimately help small food producers find success as they develop their products for market. The course also offers professional development opportunities for Extension educators to expand their knowledge-base regarding safe food production and regulation. This newly acquired knowledge can help Cooperative Extension associates develop similar courses to share with small food processors in their own communities and connect with additional audiences for outreach programming. Some examples of information included in the course: Basic background in food safety hazards including biological pathogens Hands-on demonstrations focused on using product monitoring instrumentation for preventive controls Recommended processing options based on the qualities of a food product Basic prerequisite sanitation programs (cGMPs) that are a federal requirement for all food processors Explanation of preventive controls and how to incorporate them into a food processing operation FSMA mandated requirements and exemptions for qualified facilities. In addition, this course has provided a professional development opportunity for a Cornell Ph.D. student. Shiyu Cai is a Food Science Ph.D. candidate who was also an instructor for a portion of this training. This opportunity has allowed her to increase her experience in Extension education instruction where she interacted directly with small food processors and product manufacturers offering her a chance for professional growth and contribution to her applied research. How have the results been disseminated to communities of interest?The project was presented at the 2020 FSOP National Project Directors Meeting organized by NECAFS and the final report was also sent to NECAFS for dissemination to members. The results of the training as well asthe complete evaluation data will be analyzed and compiled into a final document report that will be available on the CFVC's website. The link to this information will also be sent to over 1,600 food manufacturers and entrepreneurs of varying sizes through the CFVC's Quarterly e-Newsletter. What do you plan to do during the next reporting period to accomplish the goals? Nothing Reported

Impacts
What was accomplished under these goals? During this reporting period, the CFVC conducted two separate full-day trainings, in January 2020, that covered principles of Food Safety as well as applicable regulatory requirements for Small and Very Small Food Processors. There were 74 local attendees from diversified backgrounds split between two regional training areas, the city of Rochester, NY and the more rural area surrounding Cornell AgriTech in Geneva, NY. The majority of participants were small/very small regional food processors but also included some Extension and Food Safety educators. The goal of the training was to provide a well-rounded educational experience for the target audience focused on the basics of food safety, food preservation and regulatory requirements for small and very small food manufacturers. Since many participants had fairly new food processing businesses or were in the process of starting up a new business, this foundational knowledge was very important and helpful in understanding how their products and size of their business fit into the regulatory framework related to FSMA. The full day, eight-hour trainings included the following Modules: Food Safety and Microbiology; Safe Food Preservation; Reduced Oxygen Packaging; Current Good Manufacturing Practices; and FSMA Regulations for Small and Very Small Food Processors. There was also a short hands-on demonstration of how to use various monitoring tools and document their measurements including readings from a pH meter, a water activity meter, a spectrometer to measure Brix and a vacuum gauge. And we provided a brief tour of Cornell Food Venture Center's Pilot Plant for Fruit and Vegetable Processing. The training was developed with contributions from various members of Cornell University's Food Science Department as well as feedback from the New York State Department of Agriculture and Markets regarding state regulatory information. We included a hot lunch, coffee and snacks to be enjoyed during the breaks between instruction. Part of the training was specifically focused on defining and explaining the concept of preventive controls in general and how they relate to specific products. The CFVC offers Process Authority Services to food manufacturers of all sizes, so instructors dedicated some time to sharing and explaining the format of a Scheduled Process, and how that document could help to satisfy some preventive control requirements for Qualified Exempt facilities according to FSMA regulation (21 CFR 117 Subpart D). The CFVC has evaluated over 2000 products for safety and stability in this reporting period. An overwhelming majority of these process evaluations are conducted for small and very small food processors. The presentation also incorporated links to the Qualified Exempt Facility attestation form and guided participants in filling out the form; this allowed small producers to ask questions in reference to the regulation and how it applied to their specific businesses. And, we identified the need to print out paper copies of various regulatory applications for Amish and Mennonite participants who usually do not have access to computers or the internet. Course reaction evaluation feedback confirmed that overwhelmingly the training met participant expectations and that the speakers were received very positively by the students. Attendees indicated that the course content explaining regulatory compliance was extremely helpful; resources such as the "formats and examples of documents" and the printed copy of the slide decks "was a great book for future reference"; and the "hands-on demonstration with participation" was received positively. Suggestions for improvements from participants included: · Some participants suggested having the training broken into several shorter sessions while others agreed that although it was a long day of training, taking more than one day away from their operations would be difficult · Create an additional short course that only included regulatory module · Include breakout sessions that group people by the types of products they are making · Create a class for setting up a commercial kitchen Learning evaluations (pre and post-tests) showed an overall increase in knowledge after attending the course; responses to individual questions varied but one example showed a 45-67% improvement regarding understanding food safety hazards related to allergens. Another question showed a 40% increase in knowledge related to the income requirements to be considered a Qualified Exempt Facility. Behavioral and Organizational evaluations were also conducted 7-10 months following the training to assess how information learned in the course was incorporated into participants' business and production operations. We received feedback from about 12% of class attendees mixed from both training sites. Of those who responded 19% had incorporated documentation procedures for production operations; 19% had completed Current Good Manufacturing Practices training for themselves and/or employees; 14.3% incorporated documentation procedures for sanitation operations; and 14.3% had incorporated appropriate allergen labelling practices for their production. It should also be mentioned that this training was conducted about 6 weeks before the region began shutting down due to public safety protocols related to COVID-19. Many of the participants were on the cusp of starting new small food manufacturing businesses and attended the training to understand the regulatory information required to begin production. With this in mind, over 40% of the participants who responded to the follow-up evaluation did not end up launching their businesses in 2020 due to the economic climate related to the pandemic; this statistic obviously affected overall responses related to how attendees incorporated the information learned in the training into their businesses. However, they did find the content to be an "extremely helpful package" to use when they are ready to pursue their food innovation business in the future.

Publications


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

    Outputs
    Target Audience:During this reporting period, the Cornell Food Venture Center's efforts reached a diversified audience of regional small food manufacturers and Extension educators when conducting the pilot training of "Food Safety for Qualified Exempt Food Producers to Build Economic Viability Under the Food Safety Modernization Act" Program. Our primary goal for this outreach program is to connect with regional food manufacturers who could be classified as "Qualified Facilities" under FSMA regulations and share with them the information needed in order to comply with the recent changes in federal rules. Small and Very Small food processors would fall under the "Qualified Facilities" categories. In the region within the local program catchment area, small food processors are culturally diverse including Amish/Mennonite businesses as well as underserved urban entrepreneurs. Each of these communities require different outreach strategies in order to alert them to important trainings available in their region. To frame the marketing materials for the target audience and plan for the most accessible training site, we consulted with Judson Reid, Vegetable Specialist with Yates County Cornell Cooperative Extension, who works closely with Amish and Mennonite communities in the region. We also consulted with Laura Fox, Vice President of Rochester Downtown Development Corporation and President of The Commissary Incubator Kitchen, for feedback on reaching and training small urban food processors. Outreach strategies included email blasts to small food manufacturers who work with Cornell Food Venture Center, online event registration, shared event postings with NECAFS (Northeast Center to Advance Food Safety) and the Institute for Food Safety at Cornell University, and printed flyers posted and distributed at local produce auction sites and plain-sect community retail food outlets. To reach a wider population, we employed the help of six different Cornell Cooperative Extension offices as well as Cornell's Small Farms Program to share the event within their networks. Cornell Food Venture Center conducted one 8-hour pilot training in Geneva, NY within this reporting period that was attended by an audience of 21 people. The majority of the attendees was comprised of small food manufacturers from diversified backgrounds including Amish/Mennonite heritage. In addition, several Extension educators attended the pilot training with the goal of sharing the content through subsequent classes with food processors in their own regions who could not attend the Food Venture Center Training. By engaging Extension educators, we are also able to expand the reach of course. One course attendee represented NECAFS and was able to evaluate the content of the training and how it relates and connects to other regulatory trainings offered throughout the Northeast. Changes/Problems: Nothing Reported What opportunities for training and professional development has the project provided?The project has provided training opportunities for small and very small food processors to understand both how to produce a safe food product and the related regulatory guidelines that they must comply with at a local, state and federal level. This information will ultimately help small food producers find success as they develop their products for market. The course also offers professional development opportunities for Extension educators to expand their knowledge-base regarding safe food production and regulation. This newly acquired knowledge can help Cooperative Extension associates to develop similar courses to share with small food processors in their own communities and connect with additional audiences for outreach programming. Some examples of information included in the course: Basic background in food safety hazards including biological pathogens Hands-on demonstrations focused on using product monitoring instrumentation for preventive controls Recommended processing options based on the qualities of a food product Basic prerequisite sanitation programs (cGMPs) that are a federal requirement for all food processors Explanation of preventive controls and how to incorporate them into a food processing operation FSMA mandated requirements and exemptions for qualified facilities. In addition, this course has provided a professional development opportunity for a Cornell Ph.D. student. Shiyu Cai is a Food Science Ph.D. candidate who is also an instructor for a portion of this training. This opportunity has allowed her to increase her experience in Extension education instruction where she interacts directly with small food processors and product manufacturers offering her a chance for professional growth and contribution to her applied research. How have the results been disseminated to communities of interest?Since the initial training was recently conducted (October 25, 2019), and the entire training series has not yet been completed, the results of the program evaluations are also not complete and will not be ready to disseminate until after the close of the final trainings and evaluations in 2020. What do you plan to do during the next reporting period to accomplish the goals?During the next reporting period, the Cornell Food Venture Center plans to hold two more full day trainings in separate locations in order to best accommodate the target audience. Two trainings are currently scheduled for late January 2020. The first one will be held in Rochester, NY in partnership with The Commissary, an urban incubator kitchen, with the goal of reaching small processors in the city. The second one will be held at Cornell AgriTech in Geneva; this location is equidistant between two large Amish/Mennonite community centers located in Yates and Seneca counties in New York. We will be working closely with our community contacts in these areas to publicize the events through their networks to effectively reach the target audiences. The CFVC team will perform any needed revisions on the previously presented curriculum, based on participant and instructor feedback. We will also review the program evaluation forms and adjust any questions as needed to gather valuable information that will help design future trainings based on specific needs. The program materials will be packaged as a resource for participants to utilize and reference in their own operations; they will be available as either a bound resource book or a USB drive depending on participant needs. The CFVC also intends to follow-up with course participants several months after the training to evaluate Behavior based on the information learned in the training (Level 3 on Kirkpatrick's Four-Level Training Evaluation Model). The complete evaluation data will be analyzed and compiled into a final document report for presenting to the funding agency and project stakeholders.

    Impacts
    What was accomplished under these goals? During this reporting period, the Cornell Food Venture Center conducted an initial training that covered principles of Food Safety as well as applicable regulatory requirements for Small and Very Small Food Processors. There were 21 local attendees from diversified backgrounds at this training the majority of whom were small/very small regional food processors and some Extension and Food Safety educators. The goal of this pilot session was to identify the target audience training needs through evaluation feedback in order to appropriately shape future training materials and best serve small and very small food processors. The 1-day, eight-hour training included the following Modules: Food Safety and Microbiology; Safe Food Preservation; Reduced Oxygen Packaging; Current Good Manufacturing Practices; and FSMA Regulations for Small and Very Small Food Processors. The training was developed with contributions from various members of Cornell University's Food Science Department as well as feedback from the New York State Department of Agriculture and Markets regarding state regulatory information. The presentation incorporated links to the Qualified Facility exemption attestation form and guided participants in filling out the form; this allowed small producers to ask questions in reference to the regulation and how it applied to their specific businesses. We also identified the need to print out paper copies of various regulatory applications for Amish and Mennonite participants who usually do not have access to computers or the internet. Course reaction evaluation feedback confirmed that overwhelmingly the training met participant expectations and that the speakers were received very positively by the students. Attendees indicated that the course content explaining regulatory compliance was extremely helpful; resources such as the "formats and examples of documents" and "copies of Power Points and templates" were also helpful; and the "hands-on demonstration with participation" was received positively. Suggestions for improvements from participants included: · Revise the printed take-home resources to a slightly larger font for easier viewing as well as including a material-loaded USB drive option · Include a tour of the facility · Some participants preferred to have the training broken into two shorter days while others agreed that although it was a long day of training, taking two days away from their operations would be difficult · Create an additional short course that only included regulatory module · Offer this course to specific Cooperative Extension programs such as Aspiring Farmers Learning evaluations (pre and post-tests) showed an overall increase in knowledge after attending the course; responses to individual questions varied but one example showed a 67% improvement regarding understanding food safety hazards related to allergens. In addition, the Cornell Food Venture Center (CFVC) has evaluated over 2000 products for safety and stability in this reporting period. One of the primary functions of CFVC is to conduct process reviews for products that establish corresponding Scheduled Process documents specifying preventive control guidelines appropriate to each product. This type of document would meet the modified requirements that a Qualified Exempt Facility would need to address for product/process safety according to the Preventive Controls for Human Food Rule under FSMA regulation (21 CFR 117 Subpart D). An overwhelming majority of these process evaluations are conducted for Qualified Exempt food producers.

    Publications