Empowering Farmers to Comply with Food Safety Modernization Act (FSMA) Preventive Controls for Human Foods (PCHF)

Progress report for LNE20-398

Project Type: Research and Education
Funds awarded in 2020: $162,545.00
Projected End Date: 12/31/2023
Grant Recipients: The University of Scranton Small Business Development Center; The Pennsylvania State University
Region: Northeast
State: Pennsylvania
Project Leader:
Lisa Hall Zielinski
The University of Scranton Small Business Development Center
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Project Information

Summary:

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 (FSMA 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). 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) clarifies FSMA, and Extension and PA Farmers Union provide Produce Rule guidance, there is currently 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). Farmers’ largest hurdle is to see adding value in a new light – determining where something might “go wrong” that will compromise the safety of their product, and identifying preventive controls to address these hazards. Our project team proposes to coach producers through the process, empowering them to: judge how/if PCHF applies 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:  Initially, 120 women and small-scale producers will attend “FSMA Made Simple” (FMS) learning how/if PCHF applies to them. 65 producers will decide to remain home-based or stop adding value, saving time and money to invest elsewhere on the farm. The remaining 55 will investigate the scale of safety activity and investment needed for shelf-stable adding value; 35 will attend Good Manufacturing Practice training, gain state registration, and apply for FDA Qualified Exemption to PCHF – developing a sales records paper trail to confirm >50% direct sales. The remaining 20 will become Preventive Control Qualified Individuals (PCQIs); writing, validating and adopting food safety plans needed for transparent food safety standards. All 55 producers will have transparent food safety standards that improve their social (consumer-focused) and economic (FSMA-compliant) sustainability.

Performance Target:

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.

Introduction:

Description of Problem

Since 1997, the average farm share from each $1 food purchase has declined. Normalized 2016 data lists 12.2¢ per dollar farm returns for sales of raw food commodities. Statistics indicate farmers could retain 36.2¢ per dollar by processing, packaging, transporting, or selling wholesale (USDA/ERS, 2017); accordingly, 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).

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. Now, farmers who cut, peel or process commodities must request a Qualified Exemption from PCHF (limiting sales to 275 miles of home and complying with GMPs) OR adopt PCHF protocols. Full PCHF requires 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 be $13,000 per facility, qualified exemption between $300 and $2,000, and exempt (farms keeping records) $1,000 - amounts expected to increase with the final versions of the Produce and PCHF rules. (National Sustainable Agriculture Coalition, 2014).

Transitioning established (and starting new) value-added businesses to PCHF rule means that farmers need support to “run the numbers” to see what is cost effective, and assess their adjusted breakeven point. They need to develop a proactive mindset, predicting hazards and determining applicable preventive controls and verification tests. Penn State Extension offers Food Processing Basics (covering GMPs) and PCHF certification classes, but don’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) Last year’s inclusion of very small businesses in expected PCHF compliance provides a proxy - the consumer being able to look the farmer in the eye or drive past the farm – and as such FSMA compliance underscores “safe food legitimacy” of both processor and product.

Solution and Benefits

Adding value in the “New Era of Smarter Food Safety” (FDA, April 2019) requires farmers to assess the costs, determine actions, and initiate PCHF rule compliance. The project team proposes to utilize a one-to-one coaching technique (developed in SARE CNE10-077) 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 addresses both economic sustainability (accessing the cost/benefit of more lucrative market segments) and social sustainability (transparent, safe local food production to consumers).

580 producers will be made aware of this project, and as a result 120 will attend FSMA Made Simple sessions to introduce the subject. 65 of those who attend the introductory workshop will determine that they will not change their current activities, while the other 55 will want to explore individualized PCHF impact—beginning to see adding value in a new light – determining where something might “go wrong” that will compromise the safety of their product, and planning to adopt protocols and activities (Preventive Controls) that will address these hazards. Through additional educational sessions and individualized coaching, 55 participants will be empowered to judge how PCHF applies to them, complete training related to their specific products (35 Qualified Exemption, 20 full food safety systems as described in the PCHF rule), utilize decision tools created for this project by the team to determine and assess cost of preventive controls.

Finally, 35 will create/adopt a local marketing paper trail and 20 will draft their food safety plan, using the FDA Food Safety Plan App – to be reviewed coaches before adoption. Some plan writers will be hyper vigilant – determining that every process step presents a hazard. Clarifying questions from team members will help those producers to cull out issues over which they have no control, leaving manageable items to be addressed. To the other extreme, producers (who did not encounter food safety issues pre-FSMA) may deny that there are any processing/product hazards. Through coaching, team members can help these producers to take a less personal, high level stance – identifying what farmers already can, or should, do to set themselves apart from “others who have product safety challenges.” As a final step, food safety plan protocols and controls need to be validated by a source of authority. Team coaching will include assisting producers to confirm that planned actions are grounded in the requisite scientific principles and data, expert opinion, or in-plant observations and tests.

In this way, 55 small producers will account for the cost, and demands, of complex activities required by the PCHF rule and respond in a way that suits their unique vision and business model.

Beneficiaries and Their Interest

As substantiated by profiles of Food for Profit (FFP) class participation (SARE ENE12-125), women farmers are more likely to add value - class attendance averaging 74% women, 26% men. Therefore, expected beneficiaries are women and small-scale farmers who direct market, within Pennsylvania and Maryland.

Initial focus is on Scranton SBDC’s eight NE Pennsylvania (and twelve additional contiguous Pennsylvania/New York) counties, where 1,506 farms report direct marketing (1,019 women-operated); and ten target Maryland counties, reporting 929 farms direct market, 698 women-operated (NASS, 2017). Historical FFP attendance levels point to siting additional programming in Clarion, Butler, Lancaster and Lehigh Counties. FFP post-reports substantiate farmers’ willingness to attend classes to learn adding value, and the potential for subsequent practice adoption. ENE12-125’s final report documents that 1,223 farmers attended one of the 69 6-hour workshops between fall 2013 and summer 2016, demonstrating that producers will be interested in learning about the requirements of FSMA.

Participants’ post-workshop willingness to explore/adopt food safety protocols is 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). 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) This data supports the assertion that farmers will participate, and subsequently adopt PCHF rule requirements. Beyond these statistics, McGee has discussed the project scope with potential advisory committee members and other value-adding farmers, and determined significant producer interest.

Cooperators

Click linked name(s) to expand/collapse or show everyone's info
  • Winifred McGee (Educator)
  • Richard Kralj (Educator)
  • Ginger Myers

Research

Involves research:
No
Participation Summary

Education

Educational approach:

Awareness flyers about PCHF and “choices” of limited/cottage food business, qualified exemption and full PCHF, were distributed prior to March 1 Pennsylvania Women’s Agricultural Network (PA WAgN) and Pennsylvania Association for Sustainable Agriculture (PASA) conference, creating “fertile ground.” Recruitment of participants in educational sessions, delayed by Covid-19 restrictions on travel and gatherings, 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, PA WAgN,  the Pennsylvania Veteran Farming project, and Ag Choice Farm Credit-sponsored Ag Biz Masters program will notify their members of opportunities to join sessions – and notices will be placed on the PASA Community listserv reaching 500 producers. When face-to-face sessions are possible, advertisements in weekly newspapers and enhanced social media will attract rural/younger participants.

This recruitment will result in 120 producers attending FSMA Made Simple webinars, learning the impact of FSMA PCHF on their (planned or actual) value added activities. Follow-up emails will sent to all 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 produce.

Of these, 55 producers will request/receive F2F or Zoom support from project team members, enabling cost analysis/interpretation of individualized compliance activities, comparing full PCHF rule adoption versus Qualified Exemption.

After cost analysis, 35 producers will pursue Qualified Exemption; project team supporting their:

  • Attending a Food Processing Basics (FPB) course – a one-day class covering:
    • Food hazard analysis and controls
    • Labeling and nutritional requirements
    • Developing shelf life and product coding
    • Acidified/high acid foods
    • Regulatory requirements for acidified foods
    • Records that must be maintained
  • Applying for/upgrading their registration as (Pennsylvania) a Commercial Food Establishment or (Maryland) an On-Farm Home Processing Business
  • Creating a record system to substantiate that at least 51% of their product is sold directly to consumers (grant team-developed guide)

Another 20 producers will pursue full PCHF compliance

  • Complete FPB (if needed) and PCHF certification class, becoming a PCQI
  • Use the (team-developed) decision tool, pinpointing value-added process hazards to address
  • Determine appropriate processing, allergen and sanitation preventive controls for hazards in their control
  • Determine the responsible party to mitigate risk (if a supplier or an end-user) and the correct response
  • Use the FDA on-line App to draft their plan

Project-team coaches will review draft plans, asking clarification questions (for fine-tuning) and assist in verifying PCs, according to established standards.

As a result, 55 producers will have sustainable and (potentially) profitable value-added enterprises with the goals of transparent food safety, and retaining up to $.32 per consumer food dollar for their products (estimated at being an additional $16,000 per farm revenue).

Literature research demonstrates that the gap in PCHF-compliance education for producers adding value to shelf-stable products extends beyond our project’s initial geographical reach. Additional FMS and FPB sessions in NW, South Central and SE Pennsylvania, along with webinars and information distribution at PA WAgN’s 2021 Annual Symposium will extend coaching reach. Supporting national project replication, we plan to develop a publication similar to the CNE10-077 Coaching Guide (to share educational strategies and tools with other agricultural educators) and a Producer Guide mirroring the one in LNC16-384 (including adopter profiles)– these items highlighted by poster/concurrent session at the 2022 Extension Risk Management Education National Conference.

 

Milestones

Milestone #1 (click to expand/collapse)
What beneficiaries do and learn:

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.

Proposed number of farmer beneficiaries who will participate:

500

Actual number of farmer beneficiaries who participated:

520

Proposed Completion Date:

November 30, 2020

Status:

Completed

Date Completed:

November 20, 2020

Accomplishments:

As described in the proposal for this project, informative sheets about the impacts of FSMA on farmers adding value and direct marketing was developed in fall 2019 (as a pre-project awareness step). This information was disseminated at a booth at the PA Women in Agriculture Network 2019 Symposium in Philadelphia PA - an event attended by over 200 women farmers, growers and food advocates. This served as an initial boost for awareness of the subject.

In preparation for the first virtual sessions of "FSMA Made Simple," farmer contacts through the following routes were made - providing the following awareness message and inviting them to a webinar session:

Since 2011, the U.S. Food and Drug Administration has been developing a more proactive system for food safety across the United States. Because the Food Safety Modernization Act (FSMA) was adopted in phases, many food producers and processors were not impacted until September 2018, when the Preventive Controls for Human Foods rule included “very small businesses.” To build a profitable enterprise, it is often important to sell products out of the local area, and on the internet – making FSMA compliance mandatory. Still, a lot of confusion remains. In this session, our guest speaker, Rick Kralj, Penn State Senior Extension Educator, Food Safety & Quality, will provide an overview of FSMA Preventive Controls and answer your questions about what it means for your established business.

This material is based upon work supported by the National Institute of Food and Agriculture, U.S. Department of Agriculture, through the Northeast Sustainable Agriculture Research and Education program under subaward number LNE20-398.

This notice was distributed electronically to 

62 producers on the University of Scranton SBDC maintained agricultural email list

Ag Choice Farm Credit, for their Ag Biz registrants to share through their participant Facebook page and group notices (161 Year 1 participants, 60 Year 2 participants)

PA Women in Agriculture Network and Pennsylvania Veteran Farming Project & Troops to Tractors were provided the notice and made a commitment to disseminate electronically to their members (information in the PA Veteran Farming October 29, 2020 electronic newsletter was disseminated to 106 on their targeted list; 35% - or 37 people - opened that newsletter)

A notice was placed in the PASA Sustainable Agriculture [PASA Community] page for events

Actual accountable contacts were 520, and potentials for the two other organizations (PA WAgN 2020 communications and PASA community) increase this beyond the reported count.

While different from what we had hoped when the proposal was written, because we planned to distribute information during specialty crop related twilight meetings - and those were not held - this was still a successful launch step for the project.

 

Milestone #2 (click to expand/collapse)
What beneficiaries do and learn:

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.

Proposed number of farmer beneficiaries who will participate:

120

Actual number of farmer beneficiaries who participated:

93

Actual number of agriculture service provider beneficiaries who participated:

2

Proposed Completion Date:

March 31, 2021

Status:

In Progress

Accomplishments:

Between November 19, 2020 and September 24, 2021 six on-line sessions of "FSMA Made Simple" were presented, to a total of 21 participants. Although the fall 2020 presentation was patterned after the pilot (held summer 2019), the materials were revised at the recommendation of an Advisory Team member to include information about incorporating more "visible safety" in food production, packaging and distribution - in keeping with what local foods consumers were seeking in their "new normal." Accordingly, March and September webinars incorporated more guidance related to "immediate" steps to be taken (in keeping with consumers' heightened focus on the safety of the food served in their homes). Participants were told how these immediate actions would eventually link with FSMA rules - Preventive Controls for Human Foods, and Produce - and with their responses in the years to come. Sessions scheduled for October and November 2021 were not held due to low enrollment, but did result in 2 participants viewing an on-demand recording of a February 2021 session. This on-demand recording continues to be available for referral of producers who are seeking information about FSMA and what it will mean to their operation.

Because of inability to do face-to-face workshops as originally proposed in 2021, the team also found themselves providing specific information to farmers and local food business owners by Zoom or email communication. Thirty-two participants were provided FSMA information and adoption strategies. Some examples of the type of support given are: step-by-step coaching for FDA registration and Qualified Facility status; identification of specific standards that would need to be followed for producers applying for the USDA Value Added Producer Grant; identification of GMPs or food safety systems required for specific value-added products and/or the planned marketing venues for these products. While these interactions were important in the "teachable moment," they lacked the richness of group sessions and the networking that takes place. The project team plans to begin offering in-person sessions in early 2022, in order to increase access to this information in the group sessions that were originally planned.

The inability to do F2F programming was exacerbated by another response to the pandemic. In Pennsylvania, Department of Agriculture Inspectors were required to pivot from their usual inspection and registration of limited food enterprises (residential businesses) and food enterprises (commercial facilities) in favor of monitoring retail establishments' compliance with Covid-19 mitigation standards. The pre-Covid contact with state inspectors was usually the way that farmers adding value and start-up food producers learned about the need to comply with GMPs and FSMA - creating the teachable moment that would encourage farmers to "attend" the on-line FSMA Made Simple session.

At the same time, farmers who previously sold their products at farmers markets began using Internet sales, and additional local food producers started operations - many without applying for state level registration of their enterprises. This issue was pointed out during a three-day "New Era of Smarter Food Safety Summit on E-Commerce: Ensuring the Safety of Foods Ordered Online and Delivered Directly to Consumers" that FDA held in the middle of October, 2021. Without knowledge of the appropriate food safety requirements, many farmers simply saw Internet sales as an extension of the farmer's market or roadside stand - while the regulators were concerned about the customers' inability to judge food safety protocols and have become increasingly worried about delivery methods that take longer or require food to pass through a number of hands, increasing the potential for adulteration of the product.

Some steps to the "new normal" hold promise for this project. In fall 2021, Pennsylvania Department of Agriculture inspectors were able to step back from some of the Covid enforcement inspections that were diverting them from "routine visits" where the need to comply with FSA would have been addressed. Per discussion with PDA inspectors, they had begun to identify food businesses that started or expanded capacity in 2020/21 - who require remediation of their food safety systems to comply with state food law and Federal regulations.  A renewal of the inspectors' annual visits at food production sites will likely increase awareness, again, of the need for individualized assistance in developing the food safety systems that their current product line and marketing strategies dictate to comply with the Produce and PCHF rules in a way that makes business sense.

To regain the 2019 momentum, the team will make a concentrated effort to return to the collaborating partners who initially promoted the project in summer/fall 2020 (Ag Choice Farm Credit's Ag Biz Masters program, PASA Sustainable Agriculture, and Pennsylvania Veteran Farming Project & Troops to Tractors) to provide updated promotional messages to their contact lists. In 2022, these three groups have begun to offer face-to-face meeting opportunities again, and so will provide a key way to connect with their membership stressing the importance of "catching up with FSMA compliance."

In 2022, two notable changes occurred. As communities became more open, food safety compliance intensified with a shift from monitoring social distancing to a renewed focus on food safety systems and protocols. This shift was noticed nationally through recalls of many food products due to bacterial adulteration (infant formula, peanut butter, cheese) - but echoed across Pennsylvania as PDA inspectors expressed concern about the numerous unlicensed/non-inspected food ventures (started without inspection and oversight during the quarantine). In May 2022, the Pennsylvania Department of Agriculture's Consumer Protection - Food Safety pages were edited to emphasize the requirement to comply with the Modernized GMPs Checklist, complying with Human Food Standards addressed in FSMA. The site further stated that "All PDA registered food establishments will have to comply with the applicable portions of the Food Safety Modernization Act (FSMA) rules unless specifically exempted in the rules."  Based on conversations with participants and the tightening of regulatory expectations (which indicated that food safety standards may be confusing and complicated), “FSMA Made Simple” was rebranded The Importance of Food Safety: An Introduction to the Food Safety Modernization Act (hereafter in this report referred to as The Importance of Food Safety).

Also in 2022, the team was not able to move programming into Maryland as had been planned. Despite that setback, the team held the belief that this project needed to have an interstate focus to demonstrate that educational plan does not just fit the needs of Pennsylvania producers.  In September, USDA announced awarding grant funding to Cornell Cooperative Extension Sullivan County (CCESC) and partners that would enable them to expand existing food safety educational and outreach efforts in Sullivan and Delaware Counties NY and Wayne County, PA. This grant also provides training and consulting for fruit and vegetable producers - both those covered by (as well as those exempt from) the FSMA Produce Safety Rule. The grant also provides training and consulting for third party Good Agricultural Practice (GAP) audit (often a condition for producers to sell wholesale). Since the projects serve a similar target group, conversations with the PI for the USDA Research Project determined that our NE SARE business awareness and strategy project could mesh very well with the tech assistance and training from Cornell Cooperative Extension, without a duplication of effort. A member of this Cornell’s team, originally scheduled to attend the November 29, 2022 session of The Importance of Food Safety in Honesdale PA (Wayne County), was prevented from attending due to personal emergency but plans to attend an upcoming February 22, 2023 session at the same location to spur along this collaboration. It is the SARE project team's vision that this coordination will lead to The Importance of Food Safety potentially being offered in New York state in 2023 as well as in Pennsylvania.

Some accomplishments related to this milestone were noted. FSMA awareness webinars that were planned for early 2022 were cancelled due to small enrollment; the team took time to determine changes that would be needed to regain momentum. It was acknowledged that in-person education is most effective, but because of continued participant well-being concerns, two The Importance of Food Safety webinars were offered in morning and evening on June 8, 2022. A total of 8 people attended. Recordings of the June webinar were posted for on-demand viewing, garnering two additional participants for the year’s total.

By fall, in-person contact was seen as feasible, and, for the first time since 2020, the team did offer two in-person sessions of this educational meeting in Honesdale PA, on November 28th and 29th.  The community partner for this session was The Stourbridge Project, a business incubator. Open to both agricultural professionals and the producers themselves, the sessions had 3 people attend (2 professionals, one producer). However, this "trial balloon" helped the team to break the ice, once again talking directly to participants, gaining some non-verbals and learning where clarification and elaboration of the topic will be needed in future sessions.

Having resumed in-person contact, the team plans to hold programming in this manner, starting with February 2023, returning to Honesdale and in Troy PA (Bradford County). Team members have discussed the importance of this education and empowerment with key personnel at both locations, and we believe that participation will  increase (even if modestly), bolstered by local marketing and networking efforts at both sites.

Building on the earlier experience of success through individualized contact (Zoom, email, phone), in 2022 the team used producer engagement (throughout the state) to provide introduction to FSMA and to help  farmers and local food business owners adopt appropriate business goals and the food safety systems suiting their product, type of marketing/sales, and overall business goals. Twenty-seven participants were provided FSMA information and custom adoption strategies in this manner. In all cases, producers who wanted to do online/internet sales were coached through the FDA registration process.  For 21 of the participants, the SBDC served as an "anonymous buffer" to the PDA food safety inspectors, gathering information about specific equipment and food safety standards that the producer would need to be in place to pass appropriate inspections, so that the producer could determine whether such investments were appropriate before launching or expanding their venture. A wide variety of operations were assisted, but of specific note were 8 pursuing value added dairy (ice cream), 3 cideries/vineyards, and 2 small scale livestock (exploring setting up custom slaughter). Because these were singular educational moments and therefore there was no "learning from others" that happens in an educational meeting, the goal is to recreate the originally designed model for this project - in-person group sessions throughout 2023 - with individual follow-up through farm visits, Zoom or phone.

 

Milestone #3 (click to expand/collapse)
What beneficiaries do and learn:

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.

Proposed number of farmer beneficiaries who will participate:

65

Actual number of farmer beneficiaries who participated:

1

Proposed Completion Date:

March 31, 2021

Status:

In Progress

Accomplishments:

As described in the Accomplishments for Milestone 2, there were a total of 43 producers who participated in  in FSMA Made Simple/The Importance of Food Safety: An Introduction to the Food Safety Modernization Act live webinars or on-demand recordings and 59 producers who were provided individualized support in exploring the food safety requirements of their chosen enterprise.

Because March and September 2021 webinars were altered to incorporate guidance related to "immediate" steps to be taken in response to viral transmission concerns rather than the long-term focus on FSMA adoption, and because many producers who previously had sold through farmers markets and to restaurants had (by necessity)  turned to taking orders via Internet for local sales, the idea that a farm would stop adding value or limit their products to those that could be serviced by a Limited Food Establishment registration - and therefore take down their Internet presence - was not a viable option if the producer wanted to continue to have a market presence during the height of quarantine and waves of restriction.

The original question related to stopping all production or remaining a Limited Food Establishment has once again become more relevant in 2022/2023, as the marketplace resumes activity in a more "normal" setting. Webinar participants were encouraged to fill out a post-survey but did not provide much of substance related to the "go-no go" decision. The Honesdale session, on the other hand, did provide some feedback that was useful. The sole producer who attended indicated that, based on the information he received, he would continue to grow his value-added business; he intended to modify his food safety activities because of what he had learned and he further intended to check the food safety programs of his suppliers (in concert with the Traceability standards of FSMA). This was exactly the type of information sought. The two business support professionals stated that they intended to share what they had learned with businesses with whom they have contact (including promoting the importance of those contacts attending the February 2023 session). It is hoped that future in-person sessions will have larger attendance - and that resulting intentions can be measured in a meaningful way.

As a way to gain more data related to this milestone, early in 2023, the project team intends to make contact with the 2021/2022 webinar participants, to gauge whether they resumed local sales only or if they determined that they would need to "grow" their business with FSMA in mind. This follow-up survey will provide team members the opportunity to reiterate the steps that past participants should have taken, or need to take in the near future - that is, to register with FDA, to claim the small business exemption from federal inspection under Qualified Facility and to plan for eventual compliance with Preventive Controls for Human Foods rule through a food safety system. This contact will provide the perfect opportunity to remind each producer about the opportunity to receive individualized support/coaching in FSMA compliance from the SARE project team.

 

 

 

 

Milestone #4 (click to expand/collapse)
What beneficiaries do and learn:

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.

Proposed number of farmer beneficiaries who will participate:

55

Actual number of farmer beneficiaries who participated:

20

Proposed Completion Date:

November 30, 2021

Status:

In Progress

Accomplishments:

The 2020 and 2021 revenues have been skewed substantially by supply chain issues, restaurant and wholesale contract cancellations, and producers' moving from farmers market to on-line sales. Not all farmers adding value saw a reduction in their revenues, as many customers began looking for local food sources in an effort to better "know where their food came from." However, this had little to do with food producers embracing new food safety standards and expanding the "reach" of the products sold.  

Uncertainty in the current marketplace and inflation related to food costs have also impacted on the ability to benchmark revenues as was hoped. One farmer who was provided one to one assistance in 2020 had entered the pandemic period equipped to deliver on-line orders to neighborhoods or residences - he experienced a significant increase in sales during the "quarantine" months, but as soon as the customers felt comfortable leaving their homes to shop, these sales leveled off. This means that the original survey tool that the team planned to use will no longer be a key indicator of substantial progress in adopting a food safety system.

However, this is not to say that there is less of a need for farmers and local food producers to become aware of, and take steps to adopt, food safety protocols that will enable them to expand their target market and ways to sell more of what they produce for better sustainability. In December 2021, FDA released new guidance related to the water quality aspect of the Produce Rule that farmers will need assistance putting in place; at the end of January 2022, the FDA’s Center for Food Safety and Applied Nutrition and Office of Food Policy and Response released a list of 30 draft and final guidance topics will be a priority for the FDA Foods Program to complete during the next 12 months - 10 of them having to do with FSMA. For this reason, the need to assist farmers and local food producers in understanding and complying with appropriate standards has never been more pronounced.

Absent the bench marking tool, the team was able to chart advancements during the years 2021 and 2022. Significant indicators of progress (which allow us to document participants under the modified definition of this milestone) were:

  • Three one-to-one participants (small scale beef, value-added products, and small-production cheese) were coached by team members as they developed proposals for USDA Value Added Producer Grant applications to expand their capacity to sell outside of their local area.
  • Two participants were provided resources and consultation to explore Third-Party Inspection certification, necessary to sell their dairy based desserts and sofrito to a grocery chain.
  • Three producers (herbs, exotic mushrooms, and puddings) were given the necessary support to prepare for, and pass inspections by PDA sanitarians and Produce Safety Program specialists to begin selling at the farmers' market (herbs) and at local wholesale outlets (mushrooms and puddings)
  • A producer of sauerkraut was assisted in completing her FDA registration and Qualified Facility attestation, enabling her to expand sales legally across state lines - into Maryland, New Jersey and Delaware.
  • A subscription meal plan producer (who purchases his grass-fed beef from local farmers) was provided the steps necessary to work toward selling the packaged meals wholesale to a break room vendor to increase sales across a region of Pennsylvania (still in progress).
  • Seven producers who were exploring adding value to dairy (small scale ice cream production) were guided reviewing the cost of preparations to apply for a Frozen Dessert License and a Commercial Food Establishment registration; this often entailed finding a commercial kitchen, purchasing a pasteurizer and commercial ice cream machine; and getting the food safety certification necessary; in some cases, this meant re-thinking or delay in moving forward with the venture.
  • The owner of a cidery who began selling pizza and snacks to her patrons - and had received a citation to curtail food service activities until properly licensed - was helped to evaluate facility and skills necessary to bring her operation in compliance with the Food Law, to be able to continue servicing her customers.
  • A winery owner was assisted in establishing a winery club to be able to foster repeat sales of their line of dry wines (this assistance included confirming that they were in compliance with Food Law related to winery club events); this included discussion of what might be allowed under FSMA and an analysis of the cost/benefit of adding this marketing strategy.
  • Research was performed for an orchard owner who was considering beginning to freeze cider made on the farm (to be able to supply it year round to an ice cream shop for cider sundaes). Part of the plan was to install solar panels to power the new chiller/freezer unit, and the team provided information about grant and loan programs for solar generation - empowering the grower to weigh the pros and cons of this product availability enhancement.

In February 2023, the team will evaluate the potential to redesign the cost/benefit ratio tool that was originally proposed, in concert with the new financial realities. The vision would be to increase the tool's usefulness for the participants of future The Importance of Food Safety: An Introduction to the Food Safety Modernization Act classes, assuming the appropriate indicators of progress can be found.

Milestone #5 (click to expand/collapse)
What beneficiaries do and learn:

55 producers report benchmark (previous season) value-added revenues to the project team.

Proposed number of farmer beneficiaries who will participate:

55

Proposed Completion Date:

November 30, 2021

Status:

In Progress

Accomplishments:

As stated for Milestone 4, the tool that would provide a reliable benchmark for value-added revenues needs to be updated to comply with current marketplace realities - it is hoped that by late spring/early summer 2023 this data will begin to be collected; if a reliable tool can't developed owing to continued marketplace shifts, the team will reengage the producers reported in the revised Milestone 4 activity, to learn if this support empowered them to move ahead for greater profitability and sustainability.

Milestone #6 (click to expand/collapse)
What beneficiaries do and learn:

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.

Proposed number of farmer beneficiaries who will participate:

35

Proposed Completion Date:

April 30, 2022

Status:

In Progress

Accomplishments:

The "Food Processing Basics" class is designed for F2F provision, and so it was not offered in 2021 or 2022; a pilot was developed in 2019 by Penn State Extension, making future delivery virtually turnkey if there is a substantial buy-in for in-person training in the future. A review of the materials will be accomplished to ensure that all segments reflect current food processing standards so that it can be launched as soon as feasible.

The team will also consider the resources that are being offered through the Cornell University research project for specialty crop producers, determining if any of their classes or guides will provide similar training to "Food Processing Basics" - and if there is a similarity,  producers will be referred to the Cornell project team as an alternative source of training.

 

Milestone #7 (click to expand/collapse)
What beneficiaries do and learn:

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.

Proposed number of farmer beneficiaries who will participate:

35

Actual number of farmer beneficiaries who participated:

9

Proposed Completion Date:

December 31, 2022

Status:

In Progress

Accomplishments:

During the individualized consulting sessions in 2022, the dairy producers wanting to add value, the orchard owner freezing cider and the subscription meal producer were provided information about the need to establish a Commercial Food Establishment (rather than a residential kitchen facility), and given instruction about completing the application process. Further information included the need to register with FDA and to submit their attestation as a Qualified Facility to enable them to establish these enterprises complying with the Modernized GMPs Checklist outlined by the Pennsylvania Department of Agriculture initially. Qualified Facility is seen as a "training wheels" activity on the way to full FSMA compliance when the venture has matured.

Milestone #8 (click to expand/collapse)
What beneficiaries do and learn:

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.

Proposed number of farmer beneficiaries who will participate:

35

Proposed Completion Date:

December 31, 2022

Status:

In Progress

Accomplishments:

Because of the fluctuating business/marketing climate and the team's inability to provide in-person educational sessions until the end of 2022, the development and distribution of the sales record spreadsheet has been delayed until 2023.

Milestone #9 (click to expand/collapse)
What beneficiaries do and learn:

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).

Proposed number of farmer beneficiaries who will participate:

35

Actual number of farmer beneficiaries who participated:

1

Proposed Completion Date:

December 31, 2022

Status:

In Progress

Accomplishments:

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. It will be discussed and a sample training record distributed in 2023 sessions.

Milestone #10 (click to expand/collapse)
What beneficiaries do and learn:

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.

Proposed number of farmer beneficiaries who will participate:

20

Proposed Completion Date:

April 30, 2022

Status:

In Progress

Accomplishments:

Although several producers were informed of dates/locations of the Preventive Controls for Human Foods training that was available through Penn State Extension, by the end of 2022 there was no indication of anyone having attended. Post surveys of the 2021/2022 participants will determine if any individual has fulfilled this requirement, by planning and launching his/her food safety system. Because of the November 2022 announcement of a new FSMA  Food Traceability Final Rule, the team will monitor actions on the parts of participants that will enable 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.

Milestone #11 (click to expand/collapse)
What beneficiaries do and learn:

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.

Proposed number of farmer beneficiaries who will participate:

20

Proposed Completion Date:

January 31, 2023

Status:

In Progress

Milestone #12 (click to expand/collapse)
What beneficiaries do and learn:

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).

Proposed number of farmer beneficiaries who will participate:

55

Proposed Completion Date:

February 28, 2023

Status:

In Progress

Milestone Activities and Participation Summary

Educational activities:

52 Consultations
5 Curricula, factsheets or educational tools
4 Online trainings
5 Webinars / talks / presentations
2 Workshop field days
1 Other educational activities: Farmer who determined that she needed to be registered with FDA and to file attestation for Qualified Facility received Zoom assistance in completing this process.

Participation Summary:

23 Farmers participated
2 Number of agricultural educator or service providers reached through education and outreach activities

Performance Target Outcomes

Target #1

Target: number of farmers:

55

Target: change/adoption:

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.

Target: amount of production affected:

35 producers will adopt GMPs and records supporting FDA Qualified Exemption
20 producers will draft/implement a PCHF food safety plan

Target: quantified benefit(s):

$16,000 (average) increased revenues

Additional Project Outcomes

Additional Outcomes:

All individuals registered for the November 19 and 20, 2020 sessions of FSMA Made Simple received a follow-up email; those who had attended automatically received a recording of the session. Three registrants who had not been able to attend requested and were given the recording - one of these individuals shared the recording with additional farmers with whom she has contact.

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 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 are being made to the slide set for winter 2021 sessions and future ones impacted by Covid-19 remediation.

In early 2023, the Project Team has not seen the return to in-person meetings as was expected back in 2021. It seems individuals are not as willing to devote time and sometimes even gas money to attend trainings in person. It also seems that the convenience of watching a recording on their own time is preferred over being in a classroom. While the Team understands the desire for convenience as well as saving time and money, getting together in a room can be so beneficial on many levels. Hearing other people's opinions and questions, especially when it comes to complicated information like this, can enhance the learning experience. The Team has plans to offer more in-person trainings in early 2023, yet has also shifted to identifying individual clients and focusing on teachable moments with targeted help as a way to keep the project moving forward in 2023.

Information Products

Any opinions, findings, conclusions, or recommendations expressed in this publication are those of the author(s) and do not necessarily reflect the view of the U.S. Department of Agriculture or SARE.