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: 05/31/2023
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
  • 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
Proposed Completion Date:
March 31, 2021
Status:
In Progress
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
Proposed Completion Date:
March 31, 2021
Status:
In Progress
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
Proposed Completion Date:
November 30, 2021
Status:
In Progress
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
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
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
Proposed Completion Date:
December 31, 2022
Status:
In Progress
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
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
Proposed Completion Date:
December 31, 2022
Status:
In Progress
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
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:

25 Consultations
1 Curricula, factsheets or educational tools
2 Online trainings
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
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.

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.