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Produce Safety Alliance Educators Call #31 May 21, 2018 2-3 PM EDT

Total Attendees: 78
View webinar recording
Topic: Shine Some Light Down that Rabbit Hole: Coverage & Exclusions in the PSA Grower Training
Presenter: Dr. Don Stoeckel, Midwest Extension Associate based in Columbus, OH

Call Notes

  • Overview of Webinar
  • Information for webinar came from responses from the TAN, FDA Guidance, FDA Produce Safety Network, Subject Matter Experts, and Policy Analysts, discussion and input from educators.
  • NOTE: Extensive list of resources discussed during the call is included at the end of the meeting notes.
    • Farms that are Not Covered
    • Produce that is Not Covered
    • Produce that is (partially) Exempt
    • Farms that are Qualified Exempt
    • Some Devilish Details
  • The Deal – PSA Curriculum only contains two slides for exemptions/exclusions. This is likely not going to answer all of the questions growers have, especially as they try to figure out whether training and compliance with the rule is necessary.
    • The Produce Safety Rule is evolving (e.g., guidance, reserved sections, extension in compliance dates, enforcement discretion, etc.)
    • Not all growers may need additional information about exemptions and coverage, but it is useful to many growers and can help trainers effectively answer questions.
    • Very important that PSA Trainer & Lead Trainers stay up-to-date on clarification of regulatory requirements.
  • Inspections Versus Audits
    • Participation in PSR Inspections is required
      • Driven by requirements in Federal law (FSMA)
      • Will be implemented by State regulators in many cases
      • Only some farms covered; inspections many not be annual
    • Participation in the audit program is voluntary
      • Driven by access to markets/buyer requirements
      • Implemented by third-party audit programs
      • Results in certification; certification often annual
  • FDA Resources – see resources list attached to end of meeting notes.
  • Coverage, Exemptions, & Exclusions Flow Chart
    • Good to have growers look at this document before the training. Available on FDA’s and PSA’s websites and in the PSA Grower Training manual. Serves as a primer for understanding exemptions and exclusions.
  • Businesses that Are Not Covered
    • Trainers must know that the definitions can greatly impact where a grower falls in terms of compliance. For example, the $25k cut off includes ALL produce sold (which includes those rarely consumed raw commodities!)
    • Must also keep up with the inflation adjusted values
  • Food That is Not Covered
    • Food is not covered if it is
      • Not in the definition of produce
      • Not in the definition of Raw Agricultural Commodity (RAC)
      • Produced for personal or on-farm consumption
      • ‘Rarely Consumed Raw’ (RCR; only 34 specific things)
    • A consumer cannot be a business, so food produced for on-farm restaurants is covered (but it is sold to a QEU)
    • Food grains and most other agronomic crops are not produce
  • Food That is Exempt
    • Produce that “receives commercial processing that adequately reduces the presence of microorganisms of public health significance”
    • Processed in accordance with the requirements of 21 CFR part 113, 114, or 120
      • 21 CFR 113 is thermally processed low-acid foods
      • 21 CFR 114 is acidified foods
      • 21 CFR 120 is HACCP systems
    • Treated with a validated process to eliminate spore-forming microorganisms (e.g., commercial canning processes such as tomato paste, shelf-stable tomatoes)
    • Processing such as refining, distilling, or otherwise processing to sugar, oil, spirits, wine, beer, or similar products
  • Businesses that Are Exempt
  • Less than $500,000 annual food sales (adjusted), Majority to Qualified End Users
    • Consumer
    • Restaurant or retail food establishment
      • Same state/Reservation
      • OR within 275 miles
  • Includes ALL food sales, including meats, value-added, and animal feed
  • Very important to know the definitions:
    • Food “means (1) articles used for food or drink for man or other animals, (2) chewing gum, and (3) articles used for components of any such article
    • Restaurants prepare and sell food directly to consumers for immediate consumption and include cafeterias, catering facilities, and nursing home/child care facility kitchens
    • Retail food establishments sell food directly to consumers as the primary function, including grocery stores and vending machine locations as well as farm roadside stands, CSAs, and farmers’ markets
    • Sales to Qualified End Users
      • Animal feed is not usually a sale to a qualified end user because you don’t sell directly to the animal consumer
      • BUT, pet shelters and kennels that serve food to animals ARE restaurants according to the FDA’s definition and restaurants are QEUs
      • All direct sales to consumers count because there is no distance limit on consumers, including internet sales
      • The same state/reservation/275-mile limit applies to distance between the location of the farm that grew the produce and the location of the restaurant or retail food establishment buying the produce, not the point of sale.
      • There are a few possible ways to describe where the restaurant or retail food establishment is “located”
        • The corporate headquarters, e.g., corporate pays the invoice
        • A business address of the buyer’s retail sales location(s)
        • The delivery address for the sale, especially if the produce is going to an off-site warehouse for storage then distribution to the retail location(s)
      • Current thinking from Produce Safety Network is that the location of the qualified end user, for purposes of same state/reservation/275 miles, is the location where the food is going after purchase
        • Food bought for a distribution warehouse is not a sale to a qualified end user, even if not a separate business from retail
        • Based on requirement to register as a facility
  • Reminder: The Rule is New
  • Trainers should recognize that the Rule is evolving so always look for updates and new answers to questions
    • Reliable information resources include (see resources)
    • FDA Technical Assistance Network
    • FDA Produce Safety Network staff
    • The regulatory authority under the FDA Cooperative Agreement Program in your state, if any
    • Regional FSMA Centers
    • Produce Safety Alliance, Local Foods Collaborative, and Indigenous Food and Agriculture Initiative
  • Keep in contact with the agency that is responsible for compliance in your growers’ states
  • State-enforceable legislation can include requirements not in the Produce Safety Rule
    • Whether qualified-exempt farms are required to have a person trained per 21 CFR 112.22(c) (e.g., PSA course)
    • How a qualified-exempt farm must demonstrate eligibility for the exemption
    • Whether the qualified-exempt farm can request a voluntary inspection to meet buyer requirements
  • Language can get interpreted, so care needs to be taken to only interpret Rule requirements with supporting guidance or TAN responses
  • Special Notes About Mediated Sales & Definitions of Farm/Facility and Farm Activities
    • If the business controls covered produce and carries out covered activities the business may be a covered farm or a covered facility even if it never owns the produce
    • Secondary activities farm (harvesting, packing, holding)
    • Facility (packing, holding, manufacturing/processing)
    • Know the functions of the auction, cooperative, or hub. Does the business have to register as a facility?
    • When produce auctions/cooperatives/ or hubs are solely a location for buyers and sellers to meet, sell, and transfer produce and the food is not stored, these facilities would not be considered “holding” food and would not be expected to register
  • Summary
    • Answers are likely going to be very situational. Be sure to ask enough questions to understand the grower’s situation.

Discussion & Questions

Please listen to audio recording for full discussion, questions, and answers.

  1. Variance petitions – is needs based, based on local conditions – would need to be able to justify a new Rarely Consumed Raw commodity within requirements of variance petition. These provide opportunities for diverse farming operations, but need to be used with caution. Variance petitions need to be able to justify why the petition is necessary in light of local growing conditions.
  2. Can you clarify that a majority of the FOOD has to be sold directly? Not just the majority of the produce. So, a larger grain farmer with bigger wholesale markets with a smaller direct produce operation would not fall into Qualified Exemption?
  3. Sarah Coburn: If a restaurant grows produce only for consumption in their own restaurant, is it a 'farm,' and is the produce covered? Would this be different if the farm grows produce for use in their restaurant and also for sales off-site?
    1. Tucker Diego: Similar to the Alaska situation, experienced a similar situation in Vermont. Farm producing for restaurant – issue came down to whether the food was being “sold” to restaurant – or whether it is considered one organization, under one management.  In the end, the VT logic was that the farm’s restaurant didn’t buy the raw ingredients (no sale of produce), and the restaurant sold the food on the plate (e.g., not as a raw agricultural commodity) and therefore the farm did not sell covered produce.
    2. Follow up question: Does it make sense to break up businesses and do separate Schedule Fs? Suggest the farm talk to their lawyer! Preamble comments regarding the farm definition and business structures begin with comment 74. I did not see a response that directly addressed the division of farms. This would be a good TAN question.
  4. Vicki Smith: Please review what records must be maintained by QUE's. Are all QEU's required to meet all the requirements of this Section 112.161(a)?
  • Vicki: Our understanding was that only the labeling requirements apply to QE farms.
  • Subpart O (duration of holding of records, records must be made when action is actually done, etc.)
  • Sales records, records that help them determine QEU/not QEU – documentations to show you meet the qualified exemption.
  • Required to have signage, records to prove exemption status.
  • This is very confusing for growers.
  1. How do the plants that a RAC comes from (i.e., celery transplant) figure into the $25K? Unsure of how this will be interpreted by FDA. Tucker (VT) offered that it is likely to be addressed in guidance based on a TAN response he received on this question. Similar question related to purchasing tomato plants that already have tomatoes on the vine – is this a produce sale?
  2. Lee Stivers: If a "mediated sales" organization, let's say a coop, does indeed "hold" produce (because produce may be stored for several days in a walk-in cooler, then they are a "facility"), what does that mean in terms of what they need to do to comply with FSMA, Produce Safety Rule, or some other section?
    1. Guidance on this would be very useful. When guidance does come out, it will come out in draft form – be sure to comment and include what additional information is missing.
  3. So a further concern about farm succession - based on responses I heard, now I wonder who will decide if a farm has been divided solely for purposes of qualifying for a FSMA exemption, or if there is a legitimate reason for the division. This could apply to farms where the new person coming onto the land is NOT a relative. MN just passed a tax credit for sale of farmland to a beginning farmer. If the farmland is actually sold or actually leased to someone who is going to do a produce operation and that's different in nature from the farm's existing business, we'll say cash grain -- is the fact of division of the land and the type of production going to trigger some kind of action re: an attempt to overcome the exemption thresholds?
    1. What is a legitimate division of businesses? Is this a form of FSMA evasion? State Departments of Agriculture/Health or FDA inspectors are likely to be the interpreter/decider of these situations depending on the inspectional approach in the state

Next Meeting – Monday June 25, 2018, 2 PM Eastern

  • Topic: Lead Trainer Challenges, Improving Trainer Competencies, & Professional Development Opportunities for Produce Safety Educators within the Context of Delivering PSA Grower Trainings
  • No registration is necessary. Call will be recorded and posted on the PSA website.
  • Join from PC, Mac, Linux, iOS or Android: https://cornell.zoom.us/j/426751897
  • Or Dial Toll-free: 1 877-853-5247, Meeting ID: 426 751 897

Resources referenced during the PSA Produce Safety Educator’s Call #31

May 21, 2018 In order of appearance

First few slides

Review of Inspections and Audits

Key FDA Resources

Coverage and Exemptions/Exclusions

Businesses that are not covered

Businesses that are exempt

Food that is not covered

Food that is exempt

Guidance has not been released, yet …

The rule is new (resources)