Produce Safety Educator s Call #37: PSR Draft Guidance. March 26, :30 pm Eastern

Transcription

1 Produce Safety Educator s Call #37: PSR Draft Guidance March 26, :30 pm Eastern

2 Instructions All participants are muted. There will be time for questions and answers at the end of the meeting. We may not get around to all comments/questions, BUT you may leave additional comments in the comment box to be compiled after the session. This session will be recorded and notes will be shared via the listserv and on our website after the call. 2 2

3 Items to Have Handy Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption: Guidance for Industry Available at: GuidanceDocumentsRegulatoryInformation/UCM pdf Highlighter and pen for notes Page numbers in this presentation correspond to printed draft guidance Corresponding PSA slides are noted when the provision impacts content of curriculum 3 3

4 Agenda Introduction How to Comment Review of Sections Discussion 4

5 Webinar Goals Share some thoughts from the PSA team review of the draft guidance Highlight things the PSA team thinks are important Things you might want to review further Things that might warrant comments Things that might change how we currently present information during PSA trainings due to clarification Important note: These are only the thoughts of the PSA based on our review. No additional information was provided by the FDA or any other contributors. 5

6 Draft Guidance Published Draft Guidance for Industry: Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption Guide To Minimize Food Safety Hazards of Fresh-Cut Produce: Draft Guidance for Industry Published in Federal Register on October 22, 2018 Comments can be submitted until April 22, 2019 Guidance is not legally binding, FD&C Act still applies (Pg. 5) 6

7 Tips for Submitting Comments 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. 7

8 Subpart A General Provisions (Page 8) Coverage and exemptions flow chart was modified from the previous version Relevant to Module 1, slide 7 8

9 Subpart A General Provisions Definition of Produce (Page 9-10) Clarifications were made to the definition of Produce: Produce list expanded to include items such as crabapples, dragonfruit, fiddlehead ferns, and edible flowers Ripeness or maturity level does not matter to definition Algae (seaweed, kelp) and sap are not considered produce items 9

10 Subpart A General Provisions Raw Agricultural Commodities (Page 10-11) Examples provided on the distinction between Raw Agricultural Commodities (RACs) and processed foods Irradiated papayas are a processed food Coloring a produce item does not transform it into a processed food Rarely Consumed Raw (RCR) Produce Items (Page 12) Growers producing items on the RCR list do not need to have knowledge of the cooking process the produce receives 10

11 Subpart A General Provisions (Page 13-14) Commercial Processing exemption Examples are provided of commercial processing, including refining and distilling Reiterates that FDA intends to exercise enforcement discretion for the requirement to obtain written assurance from the processor Covered Farm definition (Page 15) Role of contract harvesters Contract harvesters that only perform harvesting operations for a covered farm but do not sell the produce are performing a covered activity on behalf of the covered farm Covered farm is responsible for compliance with PSR requirements with respect to harvesting 11

12 Subpart A General Provisions Clarification for growers calculating PSR coverage status based on total produce and food sales (Page 15) Provides detailed examples of <$25,000 for determining coverage status using inflation adjusted values (Page 16-18) Recommendations for calculating exemption status without three years of sales data (relevant for new farms) (Page 16) Reminder that exemption values are based on produce sales, not produce value 12

13 Subpart A General Provisions Clarification on the definition of qualified end user (Page 19-20) Sample calculation for comparing value of food sold directly to QEU compared to other types of sales, using auction sales as an example. Sales to QEU through auctions are direct to qualified end users, if the auction does not take ownership of the food. Consumers can be anywhere, but the retail establishment or restaurant must meet the location requirement. 13

14 Subpart A General Provisions Modified Requirements for Qualified Exempt Farms (Page 23) Clarification on the recordkeeping requirements for qualified exempt farms Sales receipts or customer ledgers are examples of records that could be used to document eligibility, if records show a) the value of food item sales and b) the customer s location Still need clarification on grown or sold Relevant to Module 7, slide 27 14

15 Subpart B General Requirements In the future, we may issue additional draft guidance addressing subpart B General Requirements related to alternatives ( ) and not addressed in this guidance: You must take appropriate measures to minimize the risk of serious adverse health consequences or death Concern about broad enforcement under this provision because no guidance or details are provided here No guidance on alternatives 15

16 Subpart C Personnel Qualifications and Training (a), for those who handle covered produce (Page 29) if you hire workers in December whose assigned duties consist of performing clerical work throughout the year, and harvesting covered produce from May to October, then you could choose to delay their initial training until, for example, late April Relevant to Module 2, slide 13 Must be appropriate for the job and conducted upon hiring 17

17 Subpart C Personnel Qualifications and Training (a) and (b), for those who handle covered produce (Page 27) If such personnel are expected to handle covered produce or food contact surfaces, even infrequently, or are engaged in the supervision thereof, they must receive adequate training Module 2, slide 10 Personnel who require training has meaning that goes beyond paid farm employees who handle covered produce or touch food contact surfaces. 18

18 Subpart C Personnel Qualifications and Training Who does have to be qualified and trained in accordance with (a) and (b)? (Page 26) All personnel who handle covered produce or food contact surfaces, or who are engaged in the supervision thereof (Page 39) Personnel can include full-time, part-time, contracted, and seasonal personnel; volunteers; and paid or unpaid interns at your facility. Who does not have to be qualified and trained in accordance with (a) and (b)? (Page 27) those with duties that do not involve contact with covered produce or food contact surfaces (e.g., removing trash, sweeping floors, maintaining restrooms, maintaining or repairing non-food contact surfaces of equipment, pest control, or operating forklifts and tractors) 19

19 Subpart C Personnel Qualifications and Training (a), for those who conduct covered activities (Page 35) Example 2d. For personnel who supervise the pest control activities for your farm and do not contact covered produce or food contact surfaces, training: should include the requirements of subpart L Equipment, Tools, Buildings, and Sanitation that relate to pest control. should include your procedures related to pest control. should include how the personnel s activities while overseeing the pest control activities (e.g., handling traps and bait stations then contacting a clean food contact surface) can lead to contamination of food contact surfaces and covered produce. should include how to recognize signs of pest infestation and animal excreta. should include how pests can contaminate covered produce. However, as on the prior page for those who conduct pest control, the training is not required if they do not contact produce or surfaces. 20

20 Subpart C Personnel Qualifications and Training All required training, and (Page 38) If you employ contracted personnel, and you choose to rely on the training the contracted company (or a third-party service provider) provides, you should request training documentation from the contracted company or third-party service provider, and maintain the records to demonstrate compliance with the training requirements. Relevant to Module 2, slide 30 Some contractors must be trained, not necessarily by the farm. Ask for and retain documentation. 21

21 Subpart C Personnel Qualifications and Training , for supervisors (Page 38) You should ensure that your responsible individuals or supervisors are aware of their role in recognizing and ensuring the correction of deviations from your food safety procedures and the requirements of the Produce Safety Rule. (Page 38) You could find that you will need multiple individuals to fill this role but, in some cases, one individual could be able to perform all of the necessary duties to ensure compliance. Relevant to Module 7, slide 7 Gives information about FDA s thinking about who (and how many people) will serve in this role on a farm. 22

22 Subpart D Health & Hygiene (Page 41) Training includes personnel who do not handle covered produce or FCS themselves, but interact with personnel who do. (Page 43) You should be aware that the measures to prevent contamination described in 21 CFR (a) apply to any person who is shown to have, or appears to have, an applicable health condition... (Page 43) The Produce Safety Rule does not require (or authorize) you to obtain medical records of your personnel to determine or verify their applicable health condition. Relevant to Module 2, Slide 26 23

23 112.32(b)(3) Subpart D Health & Hygiene (Page 50) Adequate hand drying devices include single-service towels (e.g., paper towels that are disposed of after each use), single-use towels provided by a sanitary towel service (i.e., a towel rental service that launders and delivers clean towels), and electric hand dryers. Personnel should not use common or shared towels for drying hands (b)(3)(i-vi) (Page 51) Good examples provided on when hands should be washed. For example, if a worker takes out the trash to a dumpster for disposal. Relevant to Module 2, Slide 17 24

24 Subpart D Health & Hygiene (Page 50) Confusion between must and should (b)(4) Glove use (Page 52) At the end of the day, the farm could specify that personnel return the gloves to a certain work station in a fully enclosed barn where designated personnel examine, clean, and then store the gloves in a designated cabinet. (Page 53) Under some circumstances, it could be appropriate for you to instruct personnel to change gloves when they become visibly soiled at a predetermined frequency, even if the gloves remain in good condition. Relevant to Module 2, Slide 25 25

25 Subpart D Health & Hygiene Visitors (Page 54-55) Visitors could include consumers, delivery personnel, vendors, or others who are touring, conducting business, or observing your farm. (Page 55-56): Examples of ways that farms can comply with visitor policies Supervisor explains to visitors Signage where visitors will be on the farm Handouts provided to visitors Relevant to Module 2, Slide 11 26

26 Subpart E Agricultural Water Not included in draft guidance! 27

27 Subpart E Agricultural Water Final rule: Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption; Extension of Compliance Dates for Subpart E Published on March 18, 2019 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. PSA currently updating educational materials to reflect extended compliance dates 28

28 Subpart F BSAAOs and Human Waste (Page 60-61) Lists examples of biological soil amendments of animal origin (BSAAOs), however it does not provide clarification on: Agricultural tea Vermicompost Foliar application of a BSAAO (Page 62) Lists examples of untreated BSAAOs 29

29 Subpart F BSAAOs and Human Waste Validation Studies for Soil Amendment Treatments (Page 64) The validation studies upon which you rely may use any analytical method if the testing methods meet the sensitivity requirements (i.e., detection threshold) specified in 21 CFR Farms not expected to perform validation studies related to BSAAO treatment processes, however they should ensure their treatment processes have been validated. Recommends working with technical assistance resources (BSAAO suppliers, academia, extension services, and industry associations) to help evaluate validation studies. Relevant to Module 3, slide 17 30

30 Subpart F BSAAOs and Human Waste Application requirements and minimum application intervals that apply to BSAAOs (Page 67-68) Examples 4a through 4e illustrate factors to consider when applying untreated soil amendments to minimize contact with crop Relevant to Module 3, slide 19 which discusses risk reduction steps during soil amendment application 31

31 Subpart F BSAAOs and Human Waste , , (Page 70) Chart outlining the intersection of treatment method, validation metrics, and application intervals Relevant to the notes for Module 3, slide 17 33

32 Subpart F BSAAOs and Human Waste Example of a Certificate of Conformance for BSAAOs acquired from a third party (Page 72) Provides an example of documentation demonstrating that proper treatment and handling conditions have been met. For example, a farm that receives a treated BSAAO from a third party could keep a record that includes a statement such as this: A scientifically valid thermal treatment was applied and carried out with appropriate process monitoring to satisfy the microbial standard in 21 CFR 11.55(a) (sic). The BSAAO has been handled, conveyed, and stored in a manner and location to minimize the risk of contamination. 34

33 Subpart I Animals & reasonable probability that animals will contaminate covered produce (Page 76) Examples 5b and 5c, what is a reasonable probability of animals contaminating produce. (Page 85) Signs that covered produce is reasonably likely to be contaminated: Subpart K, Relevant to Module 4, Slides 7, 16 and 17 (Assessing Risks slides) 35

34 Subpart I Animals & reasonable probability that animals will contaminate covered produce (Page 76) In general, covered produce that grows completely underground, is not subject to the provisions in Subpart I. Relevant to Module 4, Slide 11 36

35 Subpart I Animals (b)(1) - Assessment...as needed (Page 78) Three examples that illustrate the concept of monitoring frequency. Relevant to Module 4, Slide (b)(2) - Significant evidence of potential contamination (Page 80-81) Five scenarios that illustrate approaches to determine significant evidence of potential contamination Relevant to Module 4, Slide 20 37

36 Subpart K Growing, Harvesting, Packing and Holding Activities Pre-Harvest Assessment 38

37 Subpart K Growing, Harvesting, Packing and Holding Activities Pre-Harvest Assessment (Page 85) Signs that covered produce is reasonably likely to be contaminated with a known or reasonably foreseeable hazard include: Excreta observed on the covered produce; Excreta observed in an area where it is reasonably likely that it has contacted or will contact nearby covered produce during harvest Animal fur, hair, or feathers observed on the covered produce; and Crop damage or destruction by animals (e.g., bite/gnaw marks; bent, uprooted, or trampled crops). 39

38 Subpart K Growing, Harvesting, Packing and Holding Activities (Page 82-83) Keep covered produce separate from excluded produce (except when placed in the same container for distribution) and Adequately clean and sanitize, as necessary, any food contact surfaces that contact excluded produce before using such food contact surfaces for covered activities on covered produce (a)(3) (Page 84) Personnel who handle covered produce or food contact surfaces, or who are engaged in the supervision thereof, must receive training related to the separation of excluded and covered produce, as applicable. 40

39 Subpart L Equipment, Tools, Buildings, and Sanitation Equipment and Tools (Page ) Examples of how growers can evaluate their equipment and tools based on construction, maintenance, and ability to clean and sanitize Growers may consider whether the suggested solutions are realistic, such as adding plastic liners and sanitizing foam pads Growers are responsible for making risk assessments for surfaces Use examples focused on food safety rather than quality issues 41

40 Subpart L Equipment, Tools, Buildings, and Sanitation Cleaning and Sanitizing Procedures (Page 98) Equipment inspection (Page ) Introduces a six-step cleaning and sanitizing routine, including a discussion of when drycleaning may be appropriate (Page 109) Consider performing a sanitizing step each time that a wet-cleaning procedure is performed 42

41 Subpart L Equipment, Tools, Buildings, and Sanitation Instruments used to measure and record conditions should be adequate for their intended use (Page 110) Recommendation to have duplicate instruments to take measurements to ensure accuracy and precision Examples include ph meters and test strips, chlorine test strips and ORP meters 43

42 Subpart L Equipment, Tools, Buildings, and Sanitation Requirements for Domesticated Animals in Fully- Enclosed Buildings (Page 119) Responsibility is on the grower to inform guard and guide dogs handlers of the potential for dogs to carry contamination into the building and to take risk reduction measures Other relevant information Americans with Disabilities Act (ADA) Requirements for service animals 44

43 Subpart L Equipment, Tools, Buildings, and Sanitation Building Requirements (Page 116) In places where condensate contacts covered produce or food contact surfaces, consider the originating surface of the condensate a food contact surface Water spraying from a spray bar onto covered produce would be considered a food contact surface Humidity inside a high tunnel could cause condensation to drip back onto a produce, consider if it is reasonable to sanitize the inside of a high tunnel 45

44 Subpart O Records The PSA Required Records Document has been updated to reflect the items on page 24 that should be recorded to support the annual review of a qualified exemption (21 CFR 112.7) 46

45 Subpart O Records (Page 134) Growers that use dry erase boards should be aware that these alone could not be used for required records. Guidance suggests that 1 week is an appropriate amount of time to perform review. 47

46 Reminders Comments can be submitted until Apr. 22, 2019 Electronic: /standards-for-the-growing-harvesting-packing-andholding-of-produce-for-human-consumption-draft Mail (for written/paper submissions): Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD

47 Questions & Discussion 49

48 Next Meeting May 20, PM Eastern Topic: Building a One-way Street: Backflow Prevention Strategies for Produce Farms Speaker: Chris Callahan, Extension Associate Professor: Agricultural Engineering, Univ. of Vermont Extension Meeting info to be sent out via the listserv closer to the time of the call Submit other topics for discussion to Gretchen (glw53@cornell.edu) 50 50

49 Produce Safety Alliance Team Northwest: Connie Fisk, Ph.D. Midwest: Don Stoeckel, Ph.D. Northeast: Betsy Bihn, Ph.D. Gretchen Wall, M.S. Laura Acuña-Maldonado, Ph.D. Michele Humiston Rob Way Southwest: Donna Clements, M.S. Southeast: Kristin Woods, Ph.D.

50 The PSA Website Join the PSA Listserv Primary listserv for grower communications Like us on Facebook Follow us on Twitter Follow us on Instagram 52