FSMA Produce Safety Rule Basics for Tree Fruits...(FSMA) • FSMA includes: – Produce Safety Rule...
Transcript of FSMA Produce Safety Rule Basics for Tree Fruits...(FSMA) • FSMA includes: – Produce Safety Rule...
Great Plains Growers ConferenceJanuary 12, 2018
Connie Fisk, PhDProduce Safety Alliance
Northwest Regional Extension Associate
FSMA Produce Safety Rule Basics for Tree Fruits
Overview
• Background on the FSMA Produce Safety Rule• Key Requirements within the FSMA Produce
Safety Rule• Produce Safety Resources• Questions
Background on the FSMA Produce Safety Rule
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
121,116Total Produce
Farms
Produce Farms Exempt Fromor Not Covered by the PSR
86,087Exempt/
Not covered
35,029Covered
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
“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…”
Labeling: FSMA Modified Requirements for Growers Who May Be Exempt
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!
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
Compliance Dates
Inspections won’t begin until 2019
Outbreaks Associated with Produce
Multistate Outbreak of Listeriosis Linked to Commercially Produced, Prepackaged Caramel Apples Made from Bidart Bros. Apples
Source: CDCFor more information: Food Safety News
Source: Food Safety News
E. coli Outbreak from Odwalla Unpasteurized Apple Juice
Listeriosis and Stone Fruit
Source: Food Safety News
Key Requirements within the FSMA Produce Safety Rule
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
Contamination Sources
Produce
Humans
Animals Water
Soil
Buildings Equipment
Tools
Training Requirements: Supervisors
• § 112.22(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!
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
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
Worker Training Topics
Proper Use of Toilets and Sinks
Clothing and Footwear
Illness and InjuryBreak areas
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)
Worker Training Resources
Signage
Training Videos
Mobile Applications
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
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
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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
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Biological Soil Amendments:Minimum Application Intervals
• There are currently no application intervalsfor 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
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
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
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
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
Water SourcesIn practice, which of these water sources would be more variable in quality?
Irrigation Methods
Is This Agricultural Water?
Peaches Pesticide application,Well water
Testing Production Water
Source Initial and Annual Testing Requirement
Public Water Supply
Copy of test results or current certificates of compliance
Ground4 times during the growing season or over
the period of a year1 or more tests per year after initial year
Surface20 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
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!
Water Quality Profile Calculators
• Western Center for Food Safety, UC Davis – http://ucfoodsafety.ucdavis.edu/files/229168.xlsx
• University of Arizona – http://agwater.arizona.edu/onlinecalc/
START:Establish water quality profile
At least 20 samples over 2-4 years
ANNUALLY AFTER START:Collect at least 5 samples for analysisAdd to 3 prior years of profile data to
create a rolling 4-year data set
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 die-
off or removal2. Re-inspect the water system,
identify problems, and make necessary changes
3. Treat the water
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
Using Surface Water Quality Profiles
• 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
FDA Water Compliance Date Extension:What Growers Should Do in the Meantime
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
Water Quality for Harvest and Postharvest Activities
• Water used for the following must have no detectable generic E. coli per 100 mLsample:– 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
• 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
Key Postharvest Water Quality Variables
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
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
Not All Packing Areas Are The Same
ClosedHas doors and windows, with some level of control over entry into the building
Open Open to the environment, may or may not be covered
Regardless of type of packing facility, risks can be reduced!
Reduce Risks in All Packing Facilities!
Keep it cleanProper facilities & break areas for workers
Pest management Keep it organizedAvoid standing water
Keep it clean
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
When stacked, the bottom of this bin becomes the top of the bin below it!
Cleaning vs. SanitizingWhat 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!
Cleaning and Sanitizing
Step 4: Apply a sanitizer approved for use on food contact surfaces. Rinsing may be necessary. Let the surface air dry.
Step 3: Rinse the surface with clean water, making sure to remove all the detergent and soil
Step 2: Apply an appropriate detergent and scrub the surfacesStep 1: Remove any obvious dirt and debris from
the food contact surface
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
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
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!
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
Transportation Requirements
• Equipment used to transport covered produce must be a) be adequately cleanedprior 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
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
• 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
Required Records
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
Produce Safety Resources
PSA Website: General Resources producesafetyalliance.cornell.edu/resources
PSA Resources: The Water Analysis Method Requirement in the Produce Safety Rule
PSA Resources: Labeled Sanitizers for Produce
PSA Resources: Records Required by the Produce Safety Rule
Farm Food Safety Plan Writing Resources
Many templates are available
Educational Materials:-- Videos-- Decision Trees-- Posters
National GAPs Programgaps.cornell.edu
National GAPs Program: Decision Trees gaps.cornell.edu/educational-materials/ decision-trees
Southwest: Donna Pahl, MS
Midwest: Don Stoeckel, PhD
Northeast: Betsy Bihn, PhD
Gretchen Wall, MSMichele Humiston
Rob Way
Southeast: Kristin Woods, PhD
Northwest: Connie Fisk, PhD
PSA Team & Regional Extension Associates
The PSA Website producesafetyalliance.cornell.edu
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• Follow us on Twitter @Produce_Safety
Elizabeth A. Bihn, Ph.D., Director, [email protected], 315.787.2625Gretchen L Wall, M.S., Coordinator, [email protected], 607.255.6806
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