Total Attendees: 102, plus 9 PSA team member panelists
View webinar recording
Presenters: PSA Team
Topic: Draft Produce Safety Rule Guidance Discussion
The notes below only highlight a few of the major take-aways from the presentation. Please listen to/watch the recorded presentation for full details and discussion.
- View the Draft Guidance
- Comment period open until April 22, 2019.
- Goals of the webinar: Share thoughts from the PSA team’s review of the draft guidance, consider things you may want to review or comment on further, and highlight how the draft guidance may impact delivery of the PSA curriculum.
- These are only the thoughts of the PSA based on our review. No additional information was provided by the FDA or any other contributors. PSA is an educational outreach team focused on produce safety. Specific questions related to compliance should be directed toward the relevant regulatory agency (FDA or your state regulatory agency).
- Tips for commenting:
- Comments that contain real examples and data that support your position are encouraged and will have the most impact.
- Provide solutions to potential challenges identified.
- Share what was missing from guidance.
- Reference specific sections of the guidance.
- View the Draft Guidance
- Subpart Review
- Subpart A – General Provisions
- Subpart B – General Requirements
- Not included in draft guidance! Mentioned in webinar to raise awareness that the scope of these provisions can be very broad and general.
- Subpart C – Personnel Qualifications and Training
- Subpart D – Health and Hygiene
- Subpart E – Agricultural Water
- Not included in draft guidance!
- Updates provided on the Final Rule: Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption; Extension of Compliance Dates for Subpart E.
- Compliance dates for the agricultural water provisions (subpart E) for covered produce other than sprouts are delayed to January 26, 2024, for very small businesses, January 26, 2023, for small businesses, and January 26, 2022, for all other businesses.
- FDA states in the Final Rule, response to Comment 6, that:
- “A farm’s compliance date means the date on which the farm must begin sampling a water source for its initial survey, which will eventually result in a MWQP.”
- “farms must begin sampling and testing their untreated water sources … by their compliance date. If the compliance date is not an appropriate time to engage in the relevant sampling and testing activities—for example, because of the requirement in § 112.46(b)(1)(ii) that samples be representative of your use of the water—then compliance must begin by the first relevant time period that occurs after the compliance date.”
- PSA is currently updating educational materials to reflect extended compliance dates.
- Subpart F – BSAAOs and Human Waste
- Subpart I – Animals
- Subpart K – Growing, Harvesting, Packing, and Holding Activities
- Subpart L – Equipment, Tools, Buildings, and Sanitation
- Subpart O – Records
Questions & Discussion
Question: You did not discuss dropped covered produce in this webinar. That seems like a big oversight.
Response: There is still a need for clarification in this area. The Draft Guidance did not differ substantially from the information which was provided in the PSR preamble. (As a note, there was quite a bit of discussion in the chat box and this is a big concern for many on the call. PSA encourages commenting on the draft guidance in this area especially).
Question: Agritourism/U-pick farm. If we have U-Pick, do we need to designate areas where only the visitors can pick versus workers from the farm? Our farm does not allow visitors to pick tops of the apple trees (other liabilities related to ladders), but frequently we go back to pick the tops of the trees. There have been suggestions to us that this fruit should not be for normal resale or should be sent to a processor. With strawberries, we have been told to designate an area for only U-pick customers.
Response: Draft guidance, page 55, a few examples are provided for sharing the farm’s policies with visitors, but not related to designating specific areas. This may come from audit requirements, but to our knowledge, is not a requirement in the PSR nor is it addressed in the current draft guidance.
Question: Taking produce to farmers markets. Is there an expectation that all produce has to be in non-reusable containers or wrapped?
Response: Produce must be packed into clean containers. §112.116 addresses these requirements. The PSR does not cover retail locations, though this may come under local health department requirements.
Question: If a farm is growing produce and all of it is going to processing, do they need to follow the PSR requirements?
Response: It is our understanding that this produce would not be covered by the PSR; see §112.2(b). There are documentation requirements associated with this provision.
Question: Are there requirements that visitors sign in when they come to the farm?
Response: No, however visitors must be provided with the farm’s policies and toilet and handwashing facilities must be provided. See §112.33. Examples on page 55-56 in the draft guidance outline appropriate ways that the policies can be shared with visitors.
Question: Is there a common set of FSMA understandings that all farms could use for visitors? If not, could there be?
Response: The North Central Regional Center for FSMA Training, Extension, and Technical Assistance has a fact sheet on farm stands and U-pick operations. This is not from FDA and you may still want to submit a comment on the guidance if you feel that revisions to the guidance are warranted. Each farm will likely have different policies based on their operation and function of the farm, but there are common things likely to appear in most policies such as the expectation that visitors stay with their host or pick within designated areas.
Question: For cleaning food contact surfaces or packing containers, is there a requirement that potable water be used?
Response: The requirement for water used at harvest and postharvest (such as cleaning packing containers) is that the water have no detectable generic E. coli in 100 mL. The water does not need to be potable (unless also used for drinking water). See §112.44(a). Potability includes not only bacteriological quality, but also chemical quality (nitrates, toxic metals, overall about 90 total analytes) when potability requirements match those of ‘drinking water’ per US EPA limits.
Question: How will the guidance be included in the PSA curriculum?
Response: Once guidance is final, we will update the curriculum with changes and any relevant examples. The curriculum is not updated based on draft or proposed information.
Question: I am wondering if FDA uses the term “take ownership” and “take possession” interchangeably. In MN, there’s a license category of food broker, which involves handling, ordering, invoicing, and dispatching of delivery, but not actually taking possession of the food, even though the food broker holds ownership of it. This model is being used by some of our MN farmers’ markets that are acting as food hubs. They are using an online ordering platform to receive orders from buyers, handling receipt of payment from the buyer, and disbursement of payment to growers, but the growers are doing the delivery.
Response: Page 16 of the guidance says “Produce sold by a third party on your behalf (such as when a cooperative that takes possession of your produce without taking ownership, sells your produce and returns the proceeds to you after the sale) is included in the farm’s sales. In this example, it seems as if ownership is taken. If the draft guidance does not answer the question, this would be a good comment to submit for clarification in the guidance.
Question: What happens when the buyer contracts a harvester to pick the produce? For example, a canner will contract a grower for carrots, and also contract a harvester to pick the carrots. Who's responsible for keeping records for training? Often, the grower has no contact with the contract harvester.
Response: In cases where the harvest company is a “secondary activities farm,” then the harvest company would be required as a farm to ensure that the training happens and to keep the records of training. It is unclear from the guidance if the primary production farm is required to keep records related to training received by the contract harvest crew that is not a secondary activities farm. Statements on page 15, 36, and 38 about contract labor apply. Related to keeping records, the statement on page 38 states that the farm should request training documentation. There may be cases where the records must (not should) be kept by the primary production farm, but the specifics are not resolved in the draft guidance. This is another instance where a comment may be useful if the draft guidance does not fully address your question.
Question: Are live cattle included in the qualified exemption food sales thresholds?
Response: Example 1C on page 20 of the guidance gives an example where live cattle sales are included in the food calculation. The PSA team is not aware of guidance regarding when or if animal sales could qualify as sales to a qualified end user. The status of live animals as ‘food’ comes from a definition of food that FDA already had in the FD&C Act section 201.
- Food has the meaning given in section 201(f) of the Federal Food, Drug, and Cosmetic Act. Examples of food include, but are not limited to fruits; vegetables; fish; dairy products; eggs; raw agricultural commodities for use as food or as components of food; animal feed, including pet food; food and feed ingredients and additives, including substances that migrate into food from the finished container and other articles that contact food; dietary supplements and dietary ingredients; infant formula; beverages, including alcoholic beverages and bottled water; live food animals; bakery goods; snack foods; candy; and canned foods.
Question: What about clerk who are weighing covered produce then taking money? Are gloves required? Do they have to wash hands/use gloves, each time they switch from touching covered produce to money?
Response: That scenario isn’t directly addressed in the Draft Guidance since the PSR does not address retail locations. If the clerk is selling produce on the farm, for the farm, then they would be personnel of the farm handling covered produce. It seems that person would need to be trained to handle the produce safely (but as always it is the inspector’s viewpoint that matters). There is no requirement that growers or workers use gloves. However, if gloves are used, there is the requirement that gloves (if used) need to be ‘maintained in a sanitary condition’. There is also no specific requirement that money handlers wash their hands between touching covered produce and money. § 112.32(b) does cover some specific times when hands have to be washed.
Question: This is another area where there could be confusion between must vs. should: “FDA does not expect farms to perform validation studies related to BSAAO treatment processes, however, farms ensure that the treatment processes they use have been validated to meet the standards of the PSR “….states “should”.
Response: Great point. An example of how we all might help FDA provide greater clarity in the final version of this guidance through comments.
Question: Speaking of p16 so farms have to project if they will be covered or is it the previous 3 years sales data? Just curious what to tell growers at the training when discussing ‘are you covered?’
Response (from others, not PSA):
- (Aaron Finley) NYS has stated that we will regulate according to the Rule. We will use 3 years of sales, not two years as shown in the guidance doc. The Produce Safety Rule, 21 CFR § 112.5 and the FDA draft Guidance document (page 19) clearly state that the Qualified Exemption is based on “average annual monetary value of all food the farm sold during the 3-year period preceding the applicable calendar year”. The Qualified Exemption section of FDA guidance document page 22, example 1-d calculates average annual food sales using the 2-year period preceding the applicable calendar year. The PSR specifies 3-years of food sales to calculate the average annual monetary value of all food sold. The PSR does not mention calculations using less than 3-years for coverage or Qualified Exemption under the PSR. I believe that guidance examples showing less than a three year period of sales are inconsistent with the language in the Rule.
- (Dominique Giroux) Regarding assessment of sales for farms with less than 3 years of sales: we take into account their previous three years regardless. Ex: First Year = $0; Second Year = $8,000 Third Year = $25,000; average = $16,333 therefore not covered. That has been our perspective in VT.
Next Call: May 20, 2019 - Backflow Prevention
Date & Time: Monday, May 20, 2019 - 2 PM Eastern
Title: Building a One-way Street: Backflow Prevention Strategies for Produce Farms
Speakers: Mr. Chris Callahan, Extension Associate Professor - Agricultural Engineering, University of Vermont Extension
Log-in Information: No registration is necessary. The call will be recorded and posted on our website after the meeting.
- Zoom webinar: https://cornell.zoom.us/j/138790546
- Dial toll free: 877-369-0926
- Meeting ID: 138 790 546