Final report for LNE20-398
Project Information
Problem and Justification: Farmers marketing directly often add value, making shelf-stable products to increase revenues. Many producers opt for farm kitchen production, such as Limited Food Establishments (Pennsylvania) or the Cottage Food Law (Maryland), making food for in-state, direct-to-consumer (PCHF exempt) sales. However, producers of shelf-stable products (accessing retailers, institutions, or internet sales) must be PCHF-compliant. Sustainable FSMA-era adding value requires defining a target market, determining compliance costs, investing time/money in training, and writing a plan that proactively reduces/eliminates, all POTENTIAL food safety hazards. Producers adding value must also consider consumer expectations. Lacking the face-to-face farmers’ market interaction, food packages “stand alone,” and transparently provide complete, accurate substantiation of food safety and quality (Quality Assurance and Food Safety, 2017)1. Since its 2011 inception FSMA has not been easy to understand - so producers need assistance to select and adopt appropriate practices. Although the Iowa State University food processors’ FSMA Compliance Checklist (Overdiep & Shaw, 2019)2 clarified FSMA, and Extension and PA Farmers Union provided Produce Rule guidance, there was no documentation of hands-on assistance for producers in PCHF compliance.
Solution and Approach: Per the Journal of Extension, “FSMA compliance information and technical assistance could help (farmers) enter larger, more profitable markets, enhancing the prospect of expanding their businesses, which otherwise would have to remain low in profit to continue to be exempt. For medium-sized nonexempt farmers and processors, the information would be critical for continued access to the market.” (Fouladkhah, 2017)3. Farmers’ largest hurdle was to see adding value in a new light – determining where something might “go wrong” that would compromise the safety of their product, and identifying preventive controls to address these hazards. Our project team coached producers through the process, empowering them to judge how/if PCHF applied to them, identify appropriate food safety training, utilize project team-developed decision tools to determine preventive controls, and access the FDA Food Safety Plan App to write compliant plans.
Milestones and Performance Target: In the course of this project, 520 producers were made aware of the Food Safety Modernization Act, and how it might impact on their farm operation. From these early contacts, 45 producers participated in an in-person, live webinar, or on-demand recording of the FSMA Made Simple presentation (later renamed The Importance of Food Safety: An Introduction to the Food Safety Modernization Act); an additional 113 received individualized coaching for a total of 158 beneficiaries. A review of the SBDC Customer Relation Management System demonstrated that out of these participants, 23 decided not to start, or to close, a value-added business; 30 started a new small-scale enterprise (for intra-state sales); and 41 launched or improved upon a registered Commercial Food Establishment and adopted the Good Manufacturing Practices that are the base of FSMA Preventive Controls for Human Foods (the first step toward ecommerce and interstate sales). Of the 41 growing their business, 8 participants worked with team members to register their facility with FDA and apply for Qualified Facility status (a step also needed to move to interstate sales). Altogether, 71 producers were equipped by this project to make some degree of change, demonstrating transparent food safety standards that improved their social (consumer-focused) and economic (FSMA-compliant) sustainability.
Citations:
1 What Consumers Want. (April 17, 2017) Quality Assurance and Food Safety. From https://www.qualityassurancemag.com/article/what-consumers-want/
2 Overdiep, J. & Shaw, A.M. Assisting Food Processors with Food Safety Modernization Act Compliance. (June 2019)Journal of Extension (57:3) Article 3TOT4. Available at https://joe.org/joe/2019june/pdf/JOE_v57_3tt4.pdf
3 Fouladkhah, Aliyar. The Need for Evidence Based Outreach in the Current Food Safety Regulatory Landscape. (April 2017) Journal of Extension (55:2) Article 2COM1. Available at https://www.joe.org/joe/2017april/comm1.php
55 producers will gain capacity to determine the FSMA PCHF rule’s impact for their current/planned value-added enterprises; 35 will adopt GMPs and records supporting FDA Qualified Exemption, and 20 will draft/implement a PCHF food safety plan, resulting in producers reporting $16,000 (average) increased revenues.
Description of Problem
Since 1997, the average farm share from each $1 food purchase has declined. Normalized 2016 data listed 12.2¢ per dollar farm returns for sales of raw food commodities. Statistics indicated that farmers could retain 36.2¢ per dollar by taking over the middle-of-the-supply chain activities, i.e., processing, packaging, transporting, or selling wholesale (USDA/ERS, 2017)4; accordingly, for some time, farmers have been encouraged to direct market and add value. In 2015, 114,801 American farms reported direct sales to the consumer – Pennsylvania ranked first in such sales (NASS, 2016).5
However, making and selling consumer-ready products became more costly when very small businesses were required to comply, in September 2018, with FSMA Preventive Controls for Human Foods (PCHF) rule. Prior to 2018, farmers commonly added value in a home or community kitchen, complying with cottage or limited food processing good manufacturing practices (GMPs) that echoed their family food safety standards. As of fall 2018, farmers who cut, peel or process commodities had two choices: to request a Qualified Exemption from PCHF (limiting sales to 275 miles of home and complying with GMPs) OR adopt PCHF protocols. Adopting full PCHF required attending Preventive Controls Qualified Individual (PCQI) certification training, followed by writing/adopting a proactive, science-based food safety plan. Prior to 2015, FDA estimated that full PCHF average annual compliance would cost $13,000 per facility, qualified exemption between $300 and $2,000, and exempt (farms keeping records) $1,000 - although these initial estimates were expected to increase with the final versions of the Produce and PCHF rules. (National Sustainable Agriculture Coalition, 2014). 6
Transitioning established (and starting new) value-added businesses to PCHF rule meant that farmers needed support to “run the numbers” to see what is cost effective, and assess their adjusted breakeven point. They needed to develop a proactive mindset, predicting hazards and determining applicable preventive controls and verification tests. At the time that this grant project launched, Penn State Extension offered a one-day short course, Food Processing Basics (covering GMPs) and PCHF certification classes, but they didn't provide essential individualized follow-up (coaching).
Beyond economic sustainability, PCHF adoption addresses farms’ social sustainability - empowering farmers to demonstrate tangible local food safety to the public - an especially important requirement due to concerns related to Covid-19. As discussed in the University of Vermont’s “Ten Reasons to Buy Local Food,” people believe that “(l)ocal food is safe… Local farmers aren't anonymous and they take their responsibility to the consumer seriously.” (Grubinger, 2010) 7 The inclusion of very small businesses in expected PCHF compliance as of September 2018 provided a proxy - the consumer being able to look the farmer in the eye or drive past the farm – and as such FSMA compliance came to underscore “safe food legitimacy” of both processor and product.
Solution and Benefits
Adding value in the “New Era of Smarter Food Safety” (FDA, April 2019) 8 required farmers to assess the costs, determine actions, and initiate PCHF rule compliance. The project team proposed to utilize a one-to-one coaching technique (developed in SARE CNE10-077) 9 to empower farmers to 1) identify potential food production hazards, allergens, and traceability/recall strategies, 2) evaluate the cost/benefit ratio, and 3) access appropriate training to design/verify/adopt compliant strategies. Applying this strategy to assist value-added producers in FSMA compliance addressed both economic sustainability (accessing the cost/benefit of more lucrative market segments) and social sustainability (transparent, safe local food production to consumers).
520 producers were initially made aware of this project, and as a result 158 attended FSMA Made Simple sessions - in person, "live" webinar, or on demand recording - to introduce them to the subject. Referrals from community partners, and intentional expansion of food business one-to-one coaching sessions for producers and food processors across the state, led to an additional 104 participants for the project.
A review of the PA SBDC's Customer Relationship Management (CRM) system demonstrated that, out of those who had attended the information sessions or received one-to-one consults, 23 decided not to start a business, 30 started a Limited Food Establishment (which would support their making and selling foods on the "limited" list within Pennsylvania) and another 41 began a Commercial Food Establishment (which opened their business to PCHF impact and planning to adopt protocols and activities to adopt FSMA Good Manufacturing Practices). Of the 41 whose use of a commercial kitchen would allow them to sell interstate, eight were coached via Zoom meeting to complete their registration with FDA and submit the attestation for Qualified Exemption.
In the original project, it was anticipated that those registering with FDA would adopt two sets of records required of all Qualified Facilities - documenting that at least 51% of the products were sold to "qualified end users," and that all employees were provided adequate training to ensure safe food production. Although contact with most participants was delayed until 2022 and 2023 (which did not allow enough time to introduce these activities before the grant project closed) the team did draft a Sales Record Spreadsheet and an Employee Training Record template which can be used in the future by producers adding value.
It was also anticipated that, in some cases, participants would determine that full FSMA PCHF compliance was the appropriate move, and they would draft a food safety plan, using the online FDA Food Safety Plan Builder app.10 As the project came to an end, participants had been made aware of the app but none documented the usage. Beyond the term of this grant project, it continues be an appropriate step for agriculture service providers coaching the farmers and processors to introduce producers to the Builder app and to do a review of the resulting plans prior to their adoption in the business. In this way, hyper vigilant plan writers (those determining that every process step as presenting a hazard) can receive clarifying questions from the service provider/coach to help those producers cull out issues over which they have no control, leaving manageable items to be addressed. To the other extreme, producers (who have not encountered food safety issues pre-FSMA) might deny that there are any processing/product hazards would be coached to take a less personal, high level stance – identifying what farmers already could, or should, do to set themselves apart from “others who have product safety challenges.” In this way, coaching assists with fine-tuning, not taking the place of the need for a source of authority to validate the plan protocols and controls as a final step.
By taking all steps that were outlined in this project, it was believed that small producers would be able to account for the cost, and demands, of complex activities required by the PCHF rule and respond in a way that suited their unique vision and business model.
Beneficiaries and Their Interest
As substantiated by profiles of Food for Profit (FFP) class participation (SARE ENE12-125),11 women farmers were more likely to add value - class attendance averaging 74% women, 26% men. Therefore, expected beneficiaries were women and small-scale farmers who direct marketed their products, within Pennsylvania and Maryland.
Initial focus was on Scranton SBDC’s eight NE Pennsylvania (and twelve additional contiguous Pennsylvania/New York) counties, where 1,506 farms reported direct marketing (1,019 women-operated); and ten target Maryland counties, reporting 929 farms direct market, 698 women-operated (NASS, 2017)12. Historical FFP attendance levels pointed to siting additional programming in Clarion, Butler, Lancaster and Lehigh Counties (but these F2F sessions were not possible due to the pandemic). FFP post-reports substantiated farmers’ willingness to attend classes to learn adding value, and the potential for subsequent practice adoption. ENE12-125’s final report documented that 1,223 farmers attended one of the 69 6-hour workshops between fall 2013 and summer 2016, demonstrating that producers would be interested in learning about the requirements of FSMA.
Participants’ post-workshop willingness to explore/adopt food safety protocols was demonstrated by a 2017 FFP Workshop Impact Report showing 2016/2017 FFP attendees (N=60) adopting food safety protocols - HACCP (n=30), Allergens (n=35), Recall Plans (n=28), GMPs (n=27) and GAPs (n=36) (McGee, 2018).13 Nine Cornell University/Local Food Safety Collaborative-conducted farmer/processor listening sessions in 2018 concluded that processors wanted “technical assistance and easily accessible and understandable information about the regulation.” (Bihn, et.al., 2019)14 This data supported the assertion that farmers would participate, and subsequently adopt PCHF rule requirements. Beyond these statistics, McGee had discussed the project scope with potential advisory committee members and other value-adding farmers, and determined significant producer interest. It was because of this producer interest that the team was able to pivot from F2F group sessions to individual Zoom consults that yielded results as the project emerged from pandemic isolation.
Citations:
4 USDA ERS Food Dollar Series/Food Dollar Application. (2017). USDA Economic Research Service. From https://data.ers.usda.gov/reports.aspx?ID=17885&reportPath=/FoodDollar/Real
5 Direct Farm Sales of Food Results from the 2015 Local Food Marketing Practices Survey. (ACH12-35/December 2016), USDA National Agricultural Statistics Service (NASS). From https://www.nass.usda.gov/Publications/Highlights/2016/LocalFoodsMarketingPractices_Highlights.pdf
6 Costs to Facilities and Consumers – Preventive Controls Rule (October 2014) The National Sustainable Agriculture Coalition. Found at https://sustainableagriculture.net/fsma/learn-about-the-issues/preventive-controls-rule/
7 Grubinger, Vern. Ten Reasons to Buy Local Food. (April 2010) UVM Extension’s Vermont Vegetable and Berry Program. From http://www.uvm.edu/vtvegandberry/factsheets/buylocal.html
8 Statement from Acting FDA Commissioner Ned Sharpless, M.D. and Deputy Commissioner Frant Yiannas on steps to usher the U.S. into a new era of smarter food safety. (April 30, 2019). Food and Drug Administration. From https://www.fda.gov/news-events/press-announcements/statement-acting-fda-commissioner-ned-sharpless-md-and-deputy-commissioner-frank-yiannas-steps-usher
9 Myers, Ginger S. Stimulating Maryland Agricultural Entrepreneurship through Curbside Roundtables and Individual Planning (2010) Northeast Sustainable Agriculture Research and Education #CNE 10-077. Report available at https://projects.sare.org/sare_project/cne10-077/
10 U.S. Food & Drug Administration. Food Safety Plan Builder app. Available at https://www.fda.gov/food/food-safety-moderization-act-fsma/food-safety-plan-builder
11 McGee, Winifred, L. Grunden, G. Myers, & L. Sivanandan. Enhancing Cooperative Extension capacity to support the advancement of adding value and direct marketing by farmers in the Northeast (2012) Northeast Sustainable Agriculture Research and Education #ENE 12-125. Report available at https://projects.sare.org/sare_project/ene12-125/
12 USDA Census of Agriculture, County & State Profiles. (2017). USDA National Agricultural Statistical Service. Collected numbers for subpages of 2017 Census by State | 2017 Census of Agriculture | USDA/NASS
13 McGee, Winifred, L. Kime, and J. Shannon. Workshop Impact Report. (2018) Penn State Extension. From https://rvs.umn.edu/Uploads/EvaluationsReports/6303499a-6fdc-43b2-a0d2-dc39c401e373.pdf
14 Bihn, Elizabeth A., L. Pineda-Bermudez, & L. Springer. Local Food Safety Collaborative Listening Session Report. (August 13, 2019) Cornell University. Found at: http://190pbv35v6394438e82sds2q-wpengine.netdna-ssl.com/wp-content/uploads/sites/5/2019/10/LFSC-Listening-Session-Report-9-26-19.pdf
Cooperators
- (Educator)
- (Educator)
Research
Education
Awareness flyers about PCHF and “choices” of limited/cottage food business, qualified exemption and full PCHF, were distributed prior to March 1, 2020 at the Pennsylvania Women’s Agricultural Network (PA WAgN) and Pennsylvania Association for Sustainable Agriculture (PASA) conferences, creating “fertile ground.” Further recruitment of participants in educational sessions was delayed by pandemic related restrictions on travel and gatherings, and so began in fall 2020, with first webinar sessions promoted using the Scranton SBDC’s farmer contact list (developed for “Buy Fresh, Buy Local” within a 2007 USDA RBEG, for which the SBDC was a key partner). Additionally, the Pennsylvania Veteran Farming project and Ag Choice Farm Credit-sponsored Ag Biz Masters program notified their members of opportunities to join sessions – and notices were regularly placed on the PASA Community listserv reaching a total of 520 producers. In 2022 and 2023, when face-to-face sessions were possible, advertisements in weekly newspapers and enhanced social media (as well as recommendations from PA SBDC Consultants) were used to attract rural/younger participants.
This recruitment resulted in 158 farmers and local food processors attending FSMA Made Simple/The Importance of Food Safety: An Introduction to the Food Safety Modernization Act webinars or being provided the information directly as part of a targeted consulting process, learning the impact of FSMA PCHF on their (planned or actual) value added activities. Follow-up emails were sent to all webinar and onsite class participants, reminding them of the opportunity to receive one-to-one support as they determined the best path forward for their farm, related to adding value to what they produced.
An SBDC Customer Relation Management System records review indicated that 104 participants receiving one-to-one consults were assisted in arriving in a decision related to starting or expanding a value-added enterprise (23 had decided not to start, 30 started a new small-scale business, and 41 improved FSMA compliance of their existing business). Eight of the 41 worked with project team members to register their facility with FDA and apply for Qualified Facility “exemption” from full Preventive Controls for Human Foods compliance. At project end, one producer had registered for the training to become a Preventive Controls Qualified Individual (PCQI), two had attended the Introduction to HACCP (Hazard Analysis Critical Control Points) training to apply HACCP to their operations, and one participated in a Sanitary Transport of Foods online training for food carriers, loaders and unloaders as ways to enhance their FSMA compliance for chosen products.
Although the “Food Processing Basics(FPB)” course was discontinued by Extension, all participants were introduced to the Modernized GMPs Checklist outlined by the Pennsylvania Department of Agriculture as a requirement that all food businesses must follow (i.e., the minimum in FSMA compliance), and one-to-one consults assisted producers in interpreting what this checklist meant for their individual operation.
As a result, 71 producers were documented as having started or expanded sustainable and (potentially) profitable value-added enterprises with the goals of transparent food safety.
Pandemic and inflation issues throughout the grant performance period resulted in farmers primarily trying to “hold their own,” so financial analysis of pre- and post-FSMA compliance did not provide a reliable indicator of success. However, two items – a Sales Record Spreadsheet and an Employee Training Record – were drafted, and the training record was piloted with one participant. The Information Products have been uploaded to this Final Report to be available to interested Agricultural Service Providers as they work with producers in their communities.
Literature research demonstrated that the gap in PCHF-compliance education for producers adding value to shelf-stable products extends beyond our project’s initial geographical reach. Supporting national project replication, a poster presentation, Empowering Small-Scale Farmers to Address Production and Financial Risk Management Inherent in Transitioning to Local Food Sales provided an overview of the NE SARE Project to Agriculture Service Providers attending the 2023 Extension Risk Management Education National Conference on March 28, 2023 in Chicago, IL, confirming that this project has wider capacity for adoption.
The project team also provided a concurrent session at the 2024 Extension Risk Managemen Education National Conference in Salt Lake City, UT, entitled Educating Farmers to Manage Heightened Food Safety Modernization Act (FSMA) Risks at which Agricultural Service Providers were provided an overview of the NE SARE project, and educational materials generated were shared so that producers in other communities across the country might be exposed to PCHF compliance and assisted in taking the necessary steps to build their value-added enterprises.
Milestones
500 producers in Pennsylvania and Maryland learn about the very small business impacts of the Preventive Controls for Human Foods rule, becoming aware of the “choices” of limited/cottage food business, qualified exemption and adopting full food safety plans through Constant Contact, partner organization member notification, flyers at spring/summer twilight vegetable meetings, weekly newspapers and social media.
500
520
November 30, 2020
Completed
November 20, 2020
Informative sheets about the impacts of FSMA on farmers adding value and direct marketing were disseminated to PA Women in Agriculture Network at a symposium attended by over 200 women farmers, growers and food advocates.
A notice for the first virtual sessions of "FSMA Made Simple," was distributed electronically to 62 producers on the University of Scranton SBDC agricultural email list, to 221 Ag Biz Masters participants (a project of Ag Choice Farm Credit), to 106 beneficiaries of the PA Veteran Farming Project & Troops to Tractors, and a posting on the PASA Sustainable Agriculture [PASA Community] page, for a total of 520 actual accountable contacts.
In the latter part of 2021, the project team requested that Farm Credit, PASA and PA Veteran Farming Project send an updated promotional message to their members, to ensure that their beneficiaries would be aware of the individualized support that was available.
120 producers attend “FSMA Made Simple” trainings (10 events with 12 per session) co-taught by Scranton SBDC and Penn State Extension. Sessions will cover the impact of PCHF rule on their planned (or actual) value-added enterprises.
120
158
34
March 31, 2021
Completed
December 26, 2023
An April 2020 launch did not support the series of awareness workshops for FSMA that had been proposed. The pandemic and long-term, unprecedented isolation related to the pandemic resulted in a pivot to webinars to deliver the material, despite connectivity issues for many rural producers.
From November 2020 to September 2021, six on-line sessions of "FSMA Made Simple" were presented, to a total of 21 participants, who were augmented by 2 participants viewing an on-demand recording of the session.
When early 2022 webinars were cancelled due to small enrollment; the team regrouped and two The Importance of Food Safety webinars were offered in morning and evening on June 8, 2022, to 8 participants; 2 more participants viewed the on-demand recording.
In-person workshops were finally possible in Wayne County, PA in November 2022 (3 attendees) and February 2023 (9 attendees). In March 2023, a recording of the updated presentation (webinar) was made by the team for on-demand education. The You Tube video of this presentation is found at this link: FSMA .
The team pivoted to one-to-one sessions as the way to deliver the program. An in-service session for 10 SBDC business consultants was conducted to expand the reach of the materials beyond the efforts of the project team.
An analysis of the impact of this professional development session showed it to be an effective way to replicate the project team's method of client awareness and adoption of FSMA – reaching 30 participants in 2022 and 83 participants in 2023. These contacts were added to the total number of reported producers meeting this milestone.
Changes in inspection and licensing by PDA, the advent of FSMA Traceability Rule, and new marketing strategies (such as farm based food trucks) served as updates of the materials that were shared with clients.
A poster presentation, Empowering Small-Scale Farmers to Address Production and Financial Risk Management Inherent in Transitioning to Local Food Sales provided an overview of the NE SARE Project to Extension Educators and Associates attending the 2023 Extension Risk Management Education National Conference on March 28th in Chicago, IL; 180 ag professionals in attendance; 24 had a substantive conversation with SARE project team member, McGee. A copy of this poster has been uploaded as an Information Product in the Final Report.
65 producers report on the training post-survey that, as a result of what they learned, they will either stop adding value or limit their activities to Limited Food Establishment or Cottage Food production.
65
92
March 31, 2021
Completed
December 26, 2023
Of the total of 158 producers who participated in this project, 45 attended the planned FSMA Made Simple/The Importance of Food Safety: An Introduction to the Food Safety Modernization Act live webinars/on-demand recordings; 115 participants were provided individualized support in exploring the food safety requirements of their potential or chosen enterprise.
Webinar participants (live and on demand) were encouraged to respond to a post-survey, but none did. Most in-person training participants (N = 10, n = 7) did complete a paper survey. Of these, one was planning interstate commerce, 4 were going to apply the FSMA GMPs to sell within the state, and 2 were planning to stop selling.
When a 2023 on-line survey did not produce a significant sample to gauge impact among participants who had received individual consultations, the team conducted a client records review in the SBDC Customer Relationship Management System to assess the outcome related to the no-go/go/grow decision. Although some records were inconclusive, 23 had decided not to start the potential food enterprise, 30 started a new food small scale business, and 41 built upon their existing business as a result of program participation. Of the 41 growing their business, 8 producers worked with team members to register their facility with FDA and apply for Qualified Facility status (to move to interstate sales).
Final count was 92 stopping or remaining small; 9 clearly building toward more lucrative interstate sales.
55 producers use a (project-generated) analysis tool to determine the cost/benefit ratio of the level of value-added production and marketing to determine whether Qualified Facility status or adoption of a full food safety plan is appropriate for their operation.
55
57
November 30, 2021
Completed
December 26, 2023
The pandemic brought large changes to the marketplace and the needs of producers. Instead of being able to apply a basic analysis tool to determine the cost/benefit ratio of increasing value-added production and sales, participants were assisted in developing financial projections for their unique enterprise as part of the individual consultations. A review of client notes in the SBDC Customer Relationship Management System provided evidence of 57 producers being empowered to determine costs and benefits of specific activities and protocol adoption, and leading to:
- Three USDA Value Added Producer Grant applications
- Two explorations of Third-Party Inspection certification (which would allow wholesale of product
- Ten producers guided to sell at new farmers’ market and at local wholesale outlets.
- Producers supported for specific types of value-added products (this summary supplied to demonstrate the variety of products that were supported):
- Sauerkraut
- Grass-fed beef
- 11 Dairy (ice cream, cheese, butter)
- 3 Apple cider production
- Winery
- 12 Baked goods
- 2 Microgreens
- 2 Mead/honey
- Elderberry syrup
- 4 Farm-based food trucks
- Year-round specialty crops with high tunner
- 4 Non-food (beeswax wraps, goats milk soap, herbal salves and lotions – all requiring FDA cosmetics registration)
In 2023, the team re-evaluated the potential to redesign the cost/benefit ratio tool that was originally proposed, in concert with the new financial realities. Because inflation and supply chain issues continued to impact on both the costs of production and processing (and the resulting prices that farmers must require of their customers) it was decided that there are too many factors that were not yet understood fully - and the cost/benefit tool remained on hold as the grant project ended. The team may be able to create a useful tool in 2024 or beyond, to be used by participants of future The Importance of Food Safety: An Introduction to the Food Safety Modernization Act classes, when reliable indicators of progress can be found.
55 producers report benchmark (previous season) value-added revenues to the project team.
55
71
November 30, 2021
Completed
December 26, 2023
As stated for Milestone 4, the tool that would provide a reliable benchmark for value-added revenues has yet to be created. Since continued marketplace shifts made it difficult to begin to develop a reliable tool, the team had to rely on a review of client files in the PA SBDC CRM to learn if individualized FSMA education empowered them to move ahead for greater profitability and sustainability.
This review showed that 41 producers reported adding a new or expanded enterprise on their operation, to be able to comply with the FSMA Good Manufacturing Practices, or engage new markets. Another 30 had launched the food enterprise that had been discussed during consults. These efforts were bolstered by SBDC consultants assisting in the creation of proforma startup budgets and cash flows for the new or expanding enterprises. The majority of these ventures was launched in late 2022, or sometime in 2023 - just as the project concluded. If contact is kept with these clients to introduce them to the tool for charting value-added revenues, the development of a benchmark to compare with annual revenues should allow these producers to regularly check the pulse of their value-added venture, ensuring that they chart the additional dollars to their operations - which will be a valuable management activity.
35 producers choosing to pursue Qualified Facility status participate in a one-day class, “Food Processing Basics” taught by Penn State Extension, learning food hazard analysis and controls, labeling and nutritional requirements, shelf life and coding methods, processing requirements for acidified/high acid foods and the necessary records to maintain their QF status.
35
41
April 30, 2022
Completed
December 26, 2023
The "Food Processing Basics" (piloted in 2019 by Penn State Extension) was a one-day class for farmers adding value to learn food hazard analysis and controls, labeling and nutritional requirements, how to develop shelf life and product coding, working with acidified or high acid foods, the regulatory requirements for acidified foods and the records that would need to be maintained for FSMA compliance. Because of the pandemic, this class was not offered in 2020/2021/2022 - and in 2023 the Penn State Food Safety and Quality Team decided not to offer this educational program.
As an alternative, the grant team looked at the resources that were being offered through the Cornell University research project for specialty crop producers, to determine if any of their classes or guides would provide similar training to "Food Processing Basics." However, the Cornell project was found to focus on Produce Rule rather than value added processing, and so had no alternative to "Food Processing Basics."
Ultimately, food processing basics were addressed in individual consultation mode. The review of client records showed that the 41 producers who completed Commercial Food Establishment registration were supplied with the PDA GMPs Checklist and were helped to learn product- specific protocols and activities that would be needed. This 1) compliance with GMPs, 2) registration with PDA and 3) careful recording of employee food safety training are the three prerequisites of having a Qualified Facility. Therefore, it is considered that those 41 producers reached this benchmark.
35 producers apply for or upgrade their state level registration as a Commercial Food Establishment (Pennsylvania) or an On-Farm Home Processing Business (Maryland), using this registration as the basis for their FDA Qualified Facility attestation.
35
41
December 31, 2022
Completed
December 26, 2023
During the individualized consulting sessions in 2022/23, there were 41 individual producers who wanted to add value and so took steps to upgrade their registrations and protocols to commercial food establishments (non-residential kitchens) in order to make desired products and (eventually) participate in online sales.
Business consultants coached them in completing the PDA application for commercial food establishment. Each was reminded of the PDA Modernized GMPs Checklist requirement. Although records document only 8 participants who completed FDA Registration and completed an attestation for Quality Facility, the choice to set up a Commercial Food Establishment - in a commercial (rather than residental) kitchen is considered a constructive step toward FDA Registration in keeping with this milestone.
35 producers use a (project generated) sales record spread sheet (verified by its being shared with the project team via Google sheets) to substantiate that at least 51% of their product is sold directly to consumers.
35
41
December 31, 2022
Completed
December 26, 2023
Due to the team's inability to provide in-person in-person group sessions until the end of 2022/beginning 2023 (coupled by the small response to in-person and webinar training) there was never an opportunity to disseminate and field test the sales record spreadsheet that had been drafted in early 2020. However, all participants who received one-to-one consultations leading to their gaining a Commercial Food Establishment registration were introduced to the need to track their sales of qualifying products to establish the 51%+ qualified end user had been reached (or, that their sales remained below $1M a year).
A copy of the Sample Sales Record for "Sauerkraut Station" and a blank Sales Record template was disseminated to the 8 who involved the SBDC in their FDA registration. These resources have been also been added to this report in the hope that farmers, ranchers and agricultural service providers will be able to access and use this analysis tool as value-added businesses grow in future years.
35 producers report using a simplified Employee Food Safety Training Record to document compliance with the Good Manufacturing Practices covering all food businesses (this being the only record required of QF status).
35
41
December 31, 2022
Completed
December 26, 2023
The food safety training record had been previously shared with the singular producer attendee of the November 2022 session in Honesdale as he worked to bring other family members as volunteer workers supporting value-added production. A copy of the draft training record sheet has been uploaded as an Information Resource to the Final Report for use by farmers, ranchers and agricultural service providers to establish the "trickle down" of food safety education in value-added businesses.
As mentioned above, there were 41 participants who were provided individual guidance as they prepared to start their business, or expand a home-based enterprise, to process their value-added products in a commercial kitchen. A segment of the GMPs checklist focuses on food safety training for all employees to ensure that everyone who assists with food production and handling has regular in-service updates. Even if they did not have employees immediately, producers were told about ServSafe(R) Food Handlers training and the need to have a training record for each employee (patterned after the food safety training record), tracking employees' ability to assist in compliance. This type of record will be vital in 2026 when Food Traceability rule involves a farm-to-table analysis of any potential adulteration.
20 producers pursue developing a complete food safety system, participating in a 20-hour course to become a Preventive Controls Qualified Individual (developed by the Food Safety Preventive Controls Alliance). As a result of this training, they will be able to identify potential food safety hazards to be anticipated and monitored in compliance with the PCHF rule.
20
41
April 30, 2022
Completed
December 26, 2023
All processors who set up a Commercial Food Establishment (CFE) were informed of dates/locations of the Preventive Controls for Human Foods training that was available through Penn State Extension; by the end of 2023 there was an indication that only one participant had pursued PCQI certification. For many of these participants, just getting through the steps necessary to apply for CFE was enough of a challenge in the near-term, so they will be reminded in 2024 and 2025 about opportunities to take this next step.
All 41 CFE registrants have made strides toward becoming a PCQI. Since this project started, there was recognition that there are other ways that farmers adding value can learn appropriate food safety management skills, instead of PCQI certification. The records review did show that 12 participants reported completing a ServSafe(R) Manager certification class. Two participants completed Hazard Analysis Critical Control Points (HACCP) trainings, one participated in a Sanitary Transport of Foods online training for food carriers, loaders and unloaders. This points to an expanded recognition that there is not "just one path" that needs to be taken to gain additional training for farmers adding value.
Because of the November 2022 announcement of a new FSMA Food Traceability Final Rule, the team began to monitor actions on the part of participants that enabled their compliance in 2026 (as an additional measure of equipping their business for interstate sales). At the core of this rule is a requirement that persons subject to the rule who manufacture, process, pack, or hold foods on the Food Traceability List (FTL), maintain records containing Key Data Elements (KDEs) associated with specific Critical Tracking Events (CTEs) that are passed down the food distribution chain, through retail sales of the product - and farmers (while not necessarily charting KDEs and CTEs) will need to keep physical records of fields in which the FTL applicable specialty crop were grown. The latter part of 2023, the project team was mindful of Food Traceability and addressed this as part of the consultations as the participants planned and grew their CFEs.
20 producers draft a food safety plan with project team coaching to create, adopt and verify effectiveness to enable them to have an enterprise with transparent food safety standards, positioned to sell products on-line and larger marketplaces associated with more economic sustainability.
20
41
January 31, 2023
Completed
December 26, 2023
All eight participants who registered their facility with the FDA opted to submit an attestation for Qualified Facility - which meant that they did not need to do a full PCHF compliant plan at the present time. Some guidance was provided for an orchard owner who would be wholesaling cider and needed a HACCP plan, as has been previously noted. All CFE registrants were required to attach a "business plan" and to verify the food safety systems (HACCP, Modernized GMPs, FSMA Food Safety Plan, or Other Formal Food Safety System) that they would have in place - at the time they applied for registration. This stimulated a conversation with each of the processors who would be using a commercial kitchen during the consultations, creating a teachable moment that food safety considerations didn't "stop," when they got PDA registration - but were only beginning. Participants were reminded that QF was a "training wheels" stage for businesses who would eventually grow beyond the 51%/$1M limits. A commitment on the part of the team to continue to provide dates/times/places for upcoming PCQI training will further the emphasis on eventually tackling drafting and adopting a full FSMA food safety plan.
55 producers report, via their sales record spreadsheet with the project team, an average $16,000 increase in value-added related revenues (when comparing the year’s receipts to the benchmark numbers collected in milestone 5).
55
February 28, 2023
Incomplete
As explained in the accomplishments section for Milestone 4, the financial fluctuations experienced during and since the pandemic made it not-yet-possible to create a realistic analysis tool for the "new normal." For that reason, no participants were able to demonstrate impact in this area by the time that the project concluded. Potentially, future work on the part of the University of Scranton SBDC will include the development of this type of instrument that will allow producers to chart the costs/benefits of FSMA compliance to show the payback of investments - in the same way that a farmer might chart the use of a new tractor.
Milestone Activities and Participation Summary
Educational activities:
Participation Summary:
Learning Outcomes
The number of farmers who changed KASA demonstrated this after attending an educational presentation and/or receiving individual consultation. They made a decision whether to start their value added venture (or not) - and those who did decide to do so reported submitting an application to PDA to set up a Limited or Commercial Food Establishment. This was verified by a review of the PA SBDC CRM.
The number of agricultural service providers who demonstrated KASA change was arrived at by team members listing the SBDC consultants who worked with the team to provide consultations to producers who were launching or expanding a food business.
Performance Target Outcomes
Target #1
55
55 producers will gain capacity to determine the FSMA PCHF rule’s impact for their current/planned value-added enterprises; 35 will adopt GMPs and records supporting FDA Qualified Exemption, and 20 will draft/implement a PCHF food safety plan, resulting in producers reporting $16,000 (average) increased revenues.
35 producers will adopt GMPs and records supporting FDA Qualified Exemption
20 producers will draft/implement a PCHF food safety plan
$16,000 (average) increased revenues
71
30 started a Limited Food Establishment, making food in their inspected, registered home kitchen for sale within the state of Pennsylvania. This is significant because so many producers began selling products from their homes without any registration or inspection during the pandemic and so their adopting a "cottage" food status and being registered was a major step.
41 advanced to a Commercial Food Establishment, making food in an inspected commercial kitchen, able to sell food outside the state of Pennsylvania by internet and in markets across state lines.
The 41 producers who began adding value in a Commercial Food Establishment set the stage for being able to capture additional portions of the food dollar for their products.
The proposed project centered on farmers attending meetings which could not take place in until November 2022 because of Institutional decisions about bringing people together. A key location for a farmers meeting (scheduled for spring 2023) required that we take responsibility for any Covid outbreaks and so the session was not held. For this reason, the project team turned (mid-2022) to one-by-one client interaction and was successful in surpassing goals for adoption of new practices (30 getting registered and starting in-home production; 41 registered and moving value-added production to a commercial kitchen - which would allow them to sell interstate and online), but these changes served to start or sustain the food businesses through the pandemic and into the "new normal" rather than provide them with the additional revenues were to be the measurable benefit of FSMA compliance. That 41 producers were able to continue with their pre-pandemic business intact ended up being the measurable benefit.
As a result of this project, 158 participants were provided information, consultation, and tools to start or grow a value-added agriculture business, to capture more of the food dollar on their farm.
An educational session, "FSMA Made Simple" (and later renamed "The Importance of Food Safety: An Introduction to the Food Safety Modernization Act") was attended by 11 participants in-person, 29 live webinar, and at least 11 on-demand recording. In-person participants were given the opportunity to fill out an end-of-training survey; 7 of them did respond, with one aiming toward interstate sales, four of them focusing on local/state sales, and 2 stopping selling food. Although invited to continue online after the live webinar, none of the 29 responded. On-demand recordings were not successful in getting any feedback.
Mid-2022, project team pivoted from the model of information session followed by individual consults to focus on the individual consult sessions alone, using Zoom or phone contact - this resulted in the reaching or surpassing most of the milestones, with the exception of Milestone 12.
104 participants were sent requests to complete an on-line survey in 2023 to confirm their progress in building their business, but when none of them responded to this request, the team did a review of the SBDC Customer Relation Management System records (Neoserra) to glean practice change that the survey sought to document; as a result, it was found that 23 chose not to add value or closed their enterprise, 30 started a new Limited Food Establishment (which would allow them to do direct sales only) and 41 expanded their business through a Commercial Food Establishment that would allow them to do on-line and interstate sales. The 41 expanding sales were tracked through consultation records in the CRM system to determine that they had satisfied most benchmarks.
The largest barrier to conducting this project was the inability to do the group educational sessions that were proposed. While switching to one-to-one consults did allow the team to educate many farmers, this was a very slow process - and the participants lost the opportunity to learn from each others' questions (as would have been a hallmark of the original project).
Another barrier to moving the project ahead was the impact of inflation on consumers' willingness or ability to purchase food in the same way as prior to 2020. More consumers began to turn to food pantries and SNAP benefits, removing them from the target market for value-added, farm-fresh products. Consumers who were able to purchase from retail sources began to regard venues for direct marketing (farmers markets, on-farm and CSAs) as ways to get "cheap food" to stretch their household dollars, rather than buying specialty products. So, farmers were not able to expand their market presence (and therefore increase their revenues) in the way that was expected in the 2019 project proposal. To date, their largest achievement was just to cover their costs and keep "in business." Gaining a greater share of the food dollar took the back seat to sustainability.
Additional Project Outcomes
One substantial learning during the course of this grant project was that FSMA requirements for all businesses, regardless of the level of production and marketing, will require significant investment in time and money to legally make, market and sell their value-added food products. Because most farms have finite resources, is important for producers to evaluate the financial, legal and marketing risks of starting or adding a food business. These risks have become clearer over the past 5 years, as the level of food recalls has accelerated and as new FSMA rules - notably the Food Traceability Rule - make it much easier to determine when and how a food borne illness has started. As an outcome of this NE SARE project, the project team determined that it would be important to conduct a follow-on project.
In fall 2023, the University of Scranton SBDC submitted a proposal, "Empowering Farmers Adding Value to Manage Risk with Confidence in the Food Safety Modernization Act (FSMA) Era" to the Northeast Extension Risk Management Education Center, and in February 2024 the grant ($71,159) was awarded. This project will equip participants to: apply the basic food safety standards of FSMA specified in the Modernized Good Manufacturing Practices (GMPs) to gain (or retain) their licenses to make and sell selected products (Legal Risk), protect farm investments by procuring venture-specific crop and product liability insurance (Financial Risk), and affirm that the market will bear FSMA compliance costs for their products (Market Risk).
Although not a specific focus of the NE SARE grant, the learning about costs of compliance were addressed with several participants in the course of grant-related education. Three producers were supported in relation to the USDA Value Added Producers Grant; one who asked the team for grant opportunities followed up on the recommendation of VAPG funding, drafted and submitted a proposal, and received $216,000. Two other producers were identified by Farm Credit as needing VAPG support. Both received multiple session counseling as they explored and drafted their proposals - however, due to the extreme competition of this grant program, neither were successful in gaining funding. In post-program discussions, these farmers indicated that putting together the proposals had helped them center in on what their business idea was, and gave them a clearer path forward.
One participant determined that he needed to grow his orchard operation to include a cider press on his farm, to make beverages to be sold on-farm and to wholesale to an ice cream shop to be used as cider syrup. This wholesale application required him to have upgraded refrigeration on the farm, and to (potentially) use solar panels to provide the the energy. The SBDC researched and identified opportunities for state grant funding related to alternative energy and energy-saving equipment. He also needed to develop a Hazard Analysis Critical Control Point (HACCP) plan and to have scheduled process developed for pasteurizing the cider for wholesale; the project team gave guidance through this process.
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Additional unanticipated outcomes were as follows:
The April 2020 start presented many challenges - and also meant that the team needed to do a new assessment of the "new normal" marketplace to determine the amount of a pivot we would need to have a relevant project. In December 2020, the Project Team met by Zoom with 2 Farmer Advisors (sending a recording of this meeting to 3 others) to review immediate outcomes of the two FSMA Made Simple webinars that had been held in fall 2020 and to gather suggestions for improvement. The advisors suggested Covid-19 related modifications to provide food safety optics that farmers marketing value-added products need to do immediately to the FSMA Made Simple sessions to engage farmers more quickly and provide real-time value for 2021 planning. As a result of this recommendation, changes were made to the slide set for winter 2021 sessions, and every six months, the team assessed the requirement to once again change the presentations in keeping with the changing FDA standards.
Mid-year, 2022, the Pennsylvania Department of Agriculture (PDA) revised the way that food businesses would become registered. Prior to May 2022, would-be entrepreneurs were able to have contact with sanitarians in regional offices and were assisted in preparing their applications for their Limited Food Establishment (residential kitchens) or Food Establishments (commercial kitchens).
In May 2022, PDA centralized all application review in Harrisburg, so that the first contact with the sanitarian changed - to be only after successful review of the application. Regional offices were closed, and information was online; no referrals for FSMA Made Simple would be made. The revised applications had a new emphasis on water quality and safety - and required that each entrepreneur contact the PA Department of Environmental Protection to confirm that they were using an approved public water source. This meant that the project team needed to step in as an intermediary between the producers and the regulators - to get enterprise specific guidance for start-up or expansion.
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The original intent was to launch Pennsylvania programming in 2020, and move on to Maryland producers in 2021. Pandemic-driven changes in Extension programming resulted in not advancing to Maryland. In 2023, the team made a connection with the leader of the USDA NIFA SULLIVAN COUNTY FOOD SAFETY OUTREACH PROGRAM, focused on the FSMA Produce Rule. The Agriculture Production Program Manager from Sullivan County, NY was contacted and she attended the Honesdale FSMA session in February 2023. This is the new working collaboration reported above. In the future, it is hoped that this connection will allow the sharing of materials and understanding about Preventive Controls for Human Foods and the Food Traceability Rule with producers beyond Pennsylvania borders.
The influence of the pandemic continues far beyond the emergency itself. During the pandemic, farmers who previously supported in-person meetings and who may have had limited connectivity began to communicate and get information through online sources. As communities began to open up, the cost of gasoline and the newly viewed importance of time management saw participants preferring webinar training over meetings - and most registrants for these training sessions preferred to get links to view the session "on demand," rather than joining it "live." Only at the end of 2023 did farmers begin to mention preference for face to face communication again - but having this contact at industry events like the Keystone Farm Show, Penn State's Ag Progress Days, the Mid Atlantic Fruit and Vegetable Convention and PASA Sustainable Agriculture Conference. Because the beneficiaries became more "independent," as they pursued new enterprises, they vocalized a preference for one-to-one customized consults rather than group opportunities. If doing this project again, we would focus immediately on promotions to attract one-to-one producer relationships, with awareness sessions and information booths offered at some of the events listed above.