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

• Like us on Facebook

• Follow us on Twitter @Produce_Safety

Elizabeth A. Bihn, Ph.D., Director, eab38@cornell.edu, 315.787.2625Gretchen L Wall, M.S., Coordinator, glw53@cornell.edu, 607.255.6806

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