FSMA Produce Safety Rule Basics for Tree Fruits

Transcription

1 FSMA Produce Safety Rule Basics for Tree Fruits Great Plains Growers Conference January 12, 2018 Connie Fisk, PhD Produce Safety Alliance Northwest Regional Extension Associate

2 Overview Background on the FSMA Produce Safety Rule Key Requirements within the FSMA Produce Safety Rule Produce Safety Resources Questions

3 Background on the FSMA Produce Safety Rule

4 Food Safety Modernization Act (FSMA) FSMA includes: Produce Safety Rule Preventive Controls for Human Food Preventive Controls for Animal Food Foreign Supplier Verification Programs Accreditation of Third-Party Auditors/Certification Bodies Sanitary Transportation of Human and Animal Food Prevention of Intentional Contamination/Adulteration Focused on prevention of food safety issues and encompasses the entire food system

5 Produce Farms Exempt From or Not Covered by the PSR 35,029 Covered 121,116 Total Produce 86,087 Farms Exempt/ Not covered

6 FSMA Produce Safety Rule: Exemptions and Exclusions Some farms may be exempt/excluded based on: Commodities grown (e.g., rarely consumed raw) Commercial processing that adequately reduces pathogens Canning, pasteurizing, winemaking Average annual produce sales Average annual food sales and to qualified end users Photo of canned applesauce

7 Labeling: FSMA Modified Requirements for Growers Who May Be Exempt Must prominently and conspicuously display, at the point of purchase, the name and complete business address of the farm where the produce was grown, on a label, poster, sign, placard

8 PSR-Exempt Farms Are Still Subject to Buyer Requirements Farms may be exempt from the regulation, but not from buyer requirements All growers should understand and take action to reduce food safety risks on the farm!

9 FSMA PSR vs. GAPs: What is the difference? The Produce Safety Rule is different and separate from third-party audit programs like Good Agricultural Practices (GAPs): Compliance with Produce Safety Rule is required by federal regulation for farms that are covered Participation in third-party audits is voluntary: Driven by access to markets, results in an annual certification Implemented by the USDA and third-party audit programs Requirements between the two are very similar!! For more information: K-State

10 Compliance Dates Inspections won t begin until 2019

11 Outbreaks Associated with Produce

12 Multistate Outbreak of Listeriosis Linked to Commercially Produced, Prepackaged Caramel Apples Made from Bidart Bros. Apples Source: CDC For more information: Food Safety News

13 E. coli Outbreak from Odwalla Unpasteurized Apple Juice Source: Food Safety News

14 Source: Food Safety News Listeriosis and Stone Fruit

15 Key Requirements within the FSMA Produce Safety Rule

16 Subparts of the FSMA Produce Safety Rule A General Provisions B General Requirements C Personnel Qualifications and Training D Health and Hygiene E Agricultural Water F Biological Soil Amendments of Animal Origin and Human Waste I Domesticated and Wild Animals K Growing, Harvesting, Packing, and Holding Activities L Equipment, Buildings, Tools, and Sanitation M Sprouts N Analytical Methods O Records P, Q, R Variances, Compliance, and Withdrawal of Qualified Exemptions

17 Contamination Sources Humans Soil Produce Animals Buildings Equipment Tools Water

18 Training Requirements: Supervisors (c) At least one supervisor or responsible party for your farm must have successfully completed food safety training at least equivalent to that received under standardized curriculum recognized as adequate by the FDA Attending a PSA Grower Training fulfills this requirement!

19 Worker Training Requirements Workers must have a combination of education, training, and experience to perform job assignments All workers who handle produce or touch food contact surfaces must receive training appropriate for their duties: Upon hiring At least once annually thereafter Training must be easily understood by those being trained Training must be documented

20 Training Programs Must Include Principles of food hygiene and food safety Importance of health and hygiene for all personnel and visitors Includes recognizing symptoms of injury or sickness that could contaminate produce or food contact surfaces Other training relevant to the worker s job How to communicate food safety risks to supervisors

21 Worker Training Topics Proper Use of Toilets and Sinks Clothing and Footwear Break areas Illness and Injury

22 Key Worker Hygiene Practices Maintain personal cleanliness Avoid contact with animals other than working animals and take action to minimize likelihood of contamination of covered produce Wash hands thoroughly If using gloves, maintain in an intact and sanitary manner and replace when necessary Remove or cover hand jewelry that cannot be cleaned and sanitized when covered produce is manipulated by hand Do not eat, chew gum, or use tobacco products in the area used for a covered activity (drinking beverages is permitted in designated areas)

23 Worker Training Resources Training Videos Signage Mobile Applications

24 Training Requirements: Harvest Crews Workers who harvest must be trained to: Recognize when produce cannot be harvested due to contamination risks Inspect harvest containers and equipment to be sure they are functioning, clean, and maintained Correct and report problems with harvest containers or equipment Not distribute dropped covered produce Covered produce that drops to the ground before harvest

25 Farm Visitors Growers must: Make visitors aware of the farm s food safety policies Provide access to toilet and handwashing facilities Other key information for visitors should include: Areas of the farm they are allowed to visit The importance of not visiting the farm when ill How to wash their hands Instructions to keep pets at home

26 Untreated Biological Soil Amendments of Animal Origin Untreated biological soil amendments of animal origin are considered high risk since they have not been treated to reduce or eliminate pathogens All of the following soil amendments would be considered untreated: Raw manure Aged or stacked manure Untreated manure slurries Untreated manure teas Agricultural teas with supplemental microbial nutrients Any soil amendment mixed with raw manure 26

27 Biological Soil Amendments: Minimum Application Intervals There are currently no application intervals for raw manure outlined in the Rule Does not mean FDA is suggesting a zero day interval! Growers may choose to follow NOP 90/120 rule FDA is currently pursuing further research to support application intervals for raw manure Untreated Soil Amendments Untreated amendments of animal origin such as raw manure must not be directly applied to the harvestable portion of the crop Treated Soil Amendments 0 day application interval for compost treated by a scientifically validated process 27

28 Wildlife, Domesticated Animals, and Working Animals Growing areas must be assessed for evidence of potential animal contamination Observation of animals Animal excreta Crop destruction If significant evidence of contamination is found, evaluate whether produce can be harvested Take steps to ensure that contaminated produce can be identified and not harvested

29 Monitoring Wildlife Activity During the growing season: Monitor for feces and evidence of intrusion Evaluate the risk of fecal contamination on produce (e.g., tree vs. root crop) Consider past observations and wildlife attractants Immediately prior to harvest Monitor for fecal contamination, signs of animal activity (e.g., trampling, rooting, feeding, tracks) Assess risks and decide if the crop or a portion of the crop can be safely harvested

30 Helpful Definitions Agricultural water must be safe and of adequate sanitary quality for its intended use Agricultural water means water used in covered activities on covered produce where water is intended to, or is likely to, contact covered produce or food contact surfaces Covered produce means produce that is subject to the requirements of the Produce Safety Rule The term covered produce refers to the harvestable or harvested part of the crop

31 Understanding Risks Related to Production Water Three main assessment areas for produce safety risks related to production water are: Production water source and quality The less microbial contamination, the lower the risks Application method Does water contact the harvestable portions of the crop The less contact, the lower the risks Timing of application The longer the time between application and harvest, the lower the risks

32 Water Sources In practice, which of these water sources would be more variable in quality?

33 Irrigation Methods

34 Is This Agricultural Water? Peaches Pesticide application, Well water

35 Testing Production Water Source Public Water Supply Initial and Annual Testing Requirement Copy of test results or current certificates of compliance Ground Surface 4 times during the growing season or over the period of a year 1 or more tests per year after initial year 20 or more times over a period of 2 to 4 years 5 or more samples rolled into profile every year after initial survey Profile samples must be representative of use and must be collected as close in time as practicable to, but before, harvest

36 Production Water Quality Criteria Apply to water used with a direct water application method to covered produce during production Each source of production water must be tested to evaluate whether its quality profile meets the criteria: 126 or less colony forming units (or most probable number) generic E. coli per 100 ml (CFU or MPN/100 ml) water geometric mean (GM) and 410 or less CFU (or MPN) generic E. coli/100 ml water statistical threshold value (STV) There are water quality calculators online to help with the calculations!

37 Water Quality Profile Calculators Western Center for Food Safety, UC Davis University of Arizona

38 Using Surface Water Quality Profiles START: Establish water quality profile At least 20 samples over 2-4 years ANNUALLY AFTER START: Collect at least 5 samples for analysis Add to 3 prior years of profile data to create a rolling 4-year data set IF YOUR WATER CHANGES: If the water quality profile no longer represents the quality of the water source, or you change sources, establish a new profile IF YOUR PROFILE DOES NOT MEET GM OR STV CRITERIA: As soon as practicable and no later than the following year, discontinue use of the water unless an allowed corrective measure is applied ALLOWED CORRECTIVE MEASURES: 1. Apply a time interval to allow dieoff or removal 2. Re-inspect the water system, identify problems, and make necessary changes 3. Treat the water

39 FDA Water Compliance Date Extension: What Growers Should Do in the Meantime Continue water testing To better understand water quality To meet buyer and audit requirements Develop water management strategies to identify and reduce risks such as conducting surveys of water sources If growers have never tested their water, they should start testing or at least consider the benefits Test for quantified generic E. coli Test before using the water Test during frequent use periods

40 Postharvest Water Management Water Must know initial quality and intended use How to maintain quality throughout use How to properly manage and monitor treatment, if used Antimicrobial products, including sanitizers Adding a sanitizer to water is NOT intended to wash the product, but instead to prevent cross-contamination Must be labeled for intended use, such as in water or for contact with fruits and vegetables Many sanitizers available, including organic options

41 Water Quality for Harvest and Postharvest Activities Water used for the following must have no detectable generic E. coli per 100 ml sample: Direct contact with covered produce during or after harvest Direct contact with food contact surfaces To make ice For hand washing Untreated surface water may not be used for these purposes

42 Key Postharvest Water Quality Variables Quality at start of use No detectable generic E.coli in 100 ml of sample ph Can impact sanitizer effectiveness Temperature Must be monitored to minimize potential for infiltration Turbidity Can be used to manage water change schedule

43 Worker Training for Harvest and Postharvest Practices Workers must never harvest produce destined for fresh market that is contaminated with feces Workers must never harvest or distribute dropped covered produce

44 Equipment, Tools, and Sanitation Must use equipment and tools that are of adequate design, construction, and workmanship to enable them to be adequately cleaned and properly maintained Must inspect, maintain, and clean and, when necessary and appropriate, sanitize all food contact surfaces of equipment and tools used in covered activities as frequently as reasonably necessary to protect against contamination of covered produce Must maintain and clean all non-food contact surfaces, tools and equipment when necessary to prevent contamination of produce

45 Not All Packing Areas Are The Same Open Open to the environment, may or may not be covered Closed Has doors and windows, with some level of control over entry into the building Regardless of type of packing facility, risks can be reduced!

46 Reduce Risks in All Packing Facilities! Keep it clean Proper facilities & break areas for workers Keep it clean Pest management Avoid standing water Keep it organized

47 Reduce Risks BEFORE Entering the Packing Area Clean harvest bins before using them Develop practices to minimize harvest bin contact with the soil and remove soil before entering the packing and storage areas This reduces: Risk of contamination entering packing and storage areas Organic load in wash water The frequency of which wash water needs to be changed Risks when stacking produce bins on top of each other

48 When stacked, the bottom of this bin becomes the top of the bin below it!

49 Cleaning vs. Sanitizing What is the difference and why does it matter? Cleaning: Physical removal of dirt (soil) from surfaces which can include the use of clean water and detergent Sanitizing: Treatment of a cleaned surface to reduce or eliminate microorganisms Important point: You cannot sanitize a dirty surface. Cleaning always comes first!

50 Cleaning and Sanitizing Step 1: Remove any obvious dirt and debris from the food contact surface Step 2: Apply an appropriate detergent and scrub the surfaces Step 3: Rinse the surface with clean water, making sure to remove all the detergent and soil Step 4: Apply a sanitizer approved for use on food contact surfaces. Rinsing may be necessary. Let the surface air dry.

51 Pests Pests such as birds and rodents can carry human pathogens in their feces They can also be an issue to the quality and integrity of the produce

52 Pest Control Programs Take measures to protect covered produce, food contact surfaces, and food-packing materials from contamination by pests, including routine monitoring for pests as necessary and appropriate For fully-enclosed buildings, there must be measures in place to exclude pests For partially-enclosed buildings, must take measures to prevent pests from becoming established or remove them, when present

53 Cold Storage Areas Inspect regularly to ensure the area is clean and the cooling equipment is functioning properly No condensation or dripping on produce Door and window seals are intact Cooler temperatures are monitored and recorded at the beginning of each day A cleaning and pest management program should be established for all storage areas Cooling is not required, but if used, do it properly!

54 Farm Vehicles Ideally, the vehicle that transports produce should only be used to transport produce - but this is not always possible, especially on small farms

55 Transportation Requirements Equipment used to transport covered produce must be a) be adequately cleaned prior to transporting produce and b) adequate for use in transporting covered produce If growers use equipment such as pallets, forklifts, tractors, and vehicles such that they are intended to, or likely to, contact covered produce, they must do so in a manner that minimizes the potential for contamination of covered produce or food contact surfaces with known or reasonably foreseeable hazards

56 Farm Food Safety Plan Not required by the Rule! Written document discussing farm s food safety program May include: Risk assessment of practices and environmental conditions on your farm that impact food safety Practices to reduce food safety risks Records that document practices

57 Required Records Training Document required training of personnel, including the date of training, topics covered and the persons(s) trained Soil amendments Documentation regarding treatment process either from supplier or by your own farm if done on farm Agricultural water test results Equipment & Facilities Document date and method of cleaning and sanitizing equipment subject to this subpart used in covered harvesting, packing or holding activities

58 There are many Farm Food Safety Plan writing resources available! There are many available resources, including templates pick which one works best for you Tailor templates to meet YOUR needs Template plans, recordkeeping logs, and SOPs give you someplace to start and are easier than building the plan from scratch Be sure to make it your own, so you know what is in the plan and that it will work for you

59 Produce Safety Resources

60 PSA Website: General Resources producesafetyalliance.cornell.edu/resources

61 PSA Resources: The Water Analysis Method Requirement in the Produce Safety Rule

62 PSA Resources: Labeled Sanitizers for Produce

63 PSA Resources: Records Required by the Produce Safety Rule

64 Farm Food Safety Plan Writing Resources Many templates are available

65 Educational Materials: -- Videos -- Decision Trees -- Posters National GAPs Program gaps.cornell.edu

66 National GAPs Program: Decision Trees gaps.cornell.edu/educational-materials/ decision-trees

67 Northwest: Connie Fisk, PhD PSA Team & Regional Extension Associates Midwest: Don Stoeckel, PhD Northeast: Betsy Bihn, PhD Gretchen Wall, MS Michele Humiston Rob Way Southwest: Donna Pahl, MS Southeast: Kristin Woods, PhD

68 The PSA Website producesafetyalliance.cornell.edu Like us on Facebook Follow us on Join the listserv Elizabeth A. Bihn, Ph.D., Director, Gretchen L Wall, M.S., Coordinator, glw53@cornell.edu,