FSMA Produce Rule and the Produce Safety Alliance

Elizabeth A. Bihn, Ph.D.Produce Safety Alliance Director

CASA 99th Annual MeetingApril 23, 2015

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Key Goals for Today

• Summarize FSMA Produce Rule• Share info about the

Produce Safety Alliance (PSA)

FDA Food Safety Modernization Act Produce Safety Rule

• Draft released 1-4-13• Supplemental released 9-29-14• Final Rule expected October 2015

• Proposed Produce Rule:Focus on the growing, harvesting, and post-harvest handling of produce

• Focus is on the prevention, not detection of issues

Produce Rule: Areas of Focus–Agricultural water–Biological soil amendments–Domesticated and wild animals–Personnel qualifications, training,

and health and hygiene– Equipment, tools, buildings, and

sanitation

Do you have any idea why there areas are included?

Definition of a ‘Farm’• Farm means an establishment under one

ownership in one general physical location devoted to growing and harvesting crops, the raising of animals (including seafood), or both. Pack/hold raw ag commodities Pack/hold processed food, provided that all

processed food is consumed on that farm or on another farm under the same ownership

Manufacture/process food that is not consumed on the farm but consists only of dehydrating/drying commodities, packaging and labeling without additional processing

Definition of a ‘Farm’• Why does the definition of a ‘farm’ matter?

On-farm packing and holding of produce are not subject to PC Rule unless they meet the definition of processing or manufacturing

Farms that pack or hold produce from another farm are not subject to the PC Rule

A farm would not need to register as a food facility merely because it packs or holds raw agricultural commodities grown on another farm under different ownership

Proposed Agricultural Water Standards for surface water that contacts the

edible portion of the crop

<126 CFU/MPN generic E. coli per 100 ml, geometric mean (n=5)

ANDa statistical threshold value of <410 CFU/MPN generic E. coli per 100 ml

How Often Should You Test Surface Water?

Source:Surface Water

Testing Frequency

Baseline 20 samples over 2 years

Annually Minimum 5 samples per year

If annual test does not support water

quality profile

Current annual survey, combined with new data for a

total of 20 samples

Establishing a Water Quality Profilefor Surface Water

START:Establish water quality profile

Take 20 samples over two years

ANNUALLY:Take 5 samples

Compare to established water quality profile

SAMPLING DOES NOT MATCH PROFILE:

Use the 5 annual samples, plus an additional 15 new samples (20 total) to

establish a new profile

SAMPLING DOES MATCH PROFILE:Continue to test 5 samples annually

TEN YEAR RE-EVALUATION:Take 20 samples to establish a new

water quality profile

- APPLY ALTERNATE METHODS:- Time interval to achieve 0.5 log microbial die-off per day between water application and harvest

- Time interval between harvest and end of storage to achieve microbial die-off

- Other activities that may achieve microbial die-off, i.e. washing

- Discontinue use

Soil Amendments• FDA has proposed deferring action on the use

of raw soil amendments and has proposed to remove the 9 month application interval

• FDA will be working with USDA ARS to facilitate research, risk assessment, and incentivizing composting practices

Proposed Exemptions1. Produce rarely consumed raw

2. Produce destined for ‘kill-step’ processing

3. Produce for personal/on-farm consumption

4. Make <$25,000 in all produce sales (3 year average)

Proposed Qualified Exemptions

• Farms may be exempt if they: Average gross sales of food sold in

previous 3 years is <$500,000AND

Sell to qualified end users either:A. Direct to consumerB. Restaurant, retail food establishment in same state or within 275 miles of where produce was grown

Produce Farms Exempt or Not Covered by the Produce Rule

189,000Total Produce

Farms

154,000Exempt/

Not covered

35,000Covered

Growers may be exempt from the regulation, but not from the market place.

FSMA Time Frame…in Theory!

Draft Rule Released

Final rule published in Federal Register

Large growers (>$500K) comply -

2 years

Small growers ($250-500K)

comply - 3 years

Very small growers ($25-250K) comply -

4 years

Jan 2013

Nov 2013

Oct2015

2016-

2017

2016-

2018

2016-

2019

Public Comment EndNovember 22, 2013

Supplemental Comments Due Dec. 15th

Fall 2014 2020

+

We

are

here

Add an additional 2 years to each

business size for compliance with the

water standards

It Depends!

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Which is why it is good to be talking about it now!

How is it likely is it to impact fresh produce growers?

How is it likely is it to impact state food and drug officials?

We are here!

Things you should know about FSMA and produce safety!

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www.producesafetyalliance.cornell.edu

Focused on education and extension to assist growers with meeting regulatory and market food safety requirements

• Cooperative agreement between Cornell University, FDA, and USDA

• Established in October 2010

Produce Safety Alliance

Target Audiences

• Fresh produce growers, packers, and grower cooperatives with special emphasis on small and very small scale farms and packinghouses– Not to the exclusion of any farmer

• Regulatory personnel– As part of their training

• All others interested in produce food safety, GAPs, and co-management

Primary Goals• Education and outreach to improve

understanding and implementation of Good Agricultural Practices (GAPs),co-management strategies and regulatory requirements

• Collecting and providing access to information related to produce safety, GAPs, co-management and FDA's produce safety regulation • GAPs Education and Training Materials

Conference in June 2011• Producesafetyalliance.cornell.edu

More Primary Goals• Develop a standardized educational curriculum

to increase understanding of produce safety issues and co-management strategies to reduce risks to fresh produce– As proposed, training will be required as part of the

FSMA Produce Rule

• Build national networks• Train trainers to build cadre of qualified

instructors• Conduct grower trainings• Collaborate for international training

Curriculum Development Process

Complete: May 2012

Complete: June 2012

• TTT Pilot Dec 17-18, 2014• Grower Pilot Jan 26, 2015

Complete: Dec 2012

• 10 WCs, 72 calls• 178 Unique WC Members• 549 Total WC Members

• 8 Nationwide grower focus groups

Produce Safety Alliance Curriculum

~ Seven hours of dedicated instruction including:• Worker Health, Hygiene, and Training• Water• Soil Amendments• Wildlife and Domestic Animals• Facilities, Equipment, and Tools• How to Develop a Farm Food Safety Plan

Completion of course results in certificate from Association of Food and Drug Officials (AFDO) to meet regulatory requirement for training

PSA Right Now!

• Just about ready for national launch– Pilots Complete!– Final edits and review of evaluations

• Building collaborative networks• Finalize trainer certification process– Competency areas and interview Process

• Finish AFDO certification specifics• Expanding the PSA– Hiring regional PSA personnel

Future Work

• Train-the-trainer workshops to build a network of qualified trainers across the country

• Make grower trainings widely available and accessible

• *Prepare growers to meet market demand and regulatory requirements

* Training will begin BEFORE release of the final produce rule.

Challenge #1:Building Cadre of Qualified Trainers• Diverse expertise required– Produce microbiology and production

• Ability and desire to be involved– Extension people already busy or GONE– Private trainers need to make it pay

• Funding– Growers have limited funds to pay for all

associated expenses• Trainers required to be trained– Expense and effort involved

Challenge #2:Reaching Growers

• Located in rural locations and in every state

• Diversity in geographical location

• Many are exempt from the regulation But not the MARKETPLACE ! Expected to have produce safety knowledge

• Sell into markets that do not have produce safety pressure…yet

• Small vs Large Operations

Things on the Horizon• Water Testing• Labs, labs, labs

• Water Calculations• Geometic Means• Statistical Threshold Values

• Manure application window• Sanitation questions• Sanitary design (buildings and equipment)• Detergents and sanitizer options• Sanitation practices on the farm

Beyond the PSA Curriculum

• PSA curriculum is a brain filling day• Growers need a written food safety plan• Third party audit• Buyer demand

• Turning knowledge into action• Hands on activities• Implementing practices

on the farm

Options to Support Growers• Incorporate PSA training INTO current

multi-day GAPs trainings Day 1: PSA certification Day 2: Farm food safety plan writing Already successful collaboration between Cornell,

CCE, NYSDAM Long-term survey data shows progress

• Continuing education Online and in-person modules Hands-on workshops

o Postharvest water management

32www.gaps.cornell.edu

Access to New Educational Materials

Each Decision Tree Portfolio Has…

• Overview of the topic• Decision tree • Sample Standard Operating

Procedures (SOPs)• Sample log sheets• Template food safety language

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http://ucfoodsafety.ucdavis.edu/Preharvest/Co-Management_of_Food_Safety_and_Sustainability/

Co-Management Information

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http://www.lgma.ca.gov/2014/12/dan-sutton-impact-stories-real-people/

Training Materials: Foodborne Illness Stories

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Summary• Collaboration has been key to our progress

and will be the foundation of our success• Focused on providing information and

training growers need to maintain markets and meet regulatory requirements

• Will expand to meet regulatory personnel needs and integrate it with grower training

• Provide a trail of how progress has occurred

• Always open to ideasand ways to improve

The PSA Website http://producesafetyalliance.cornell.edu/

• You can even friend us on Facebook!

• Join the listserve!

• Contact us!

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