FSMA Produce Rule and
the Produce Safety Alliance
Elizabeth A. Bihn, Ph.D.
Produce Safety Alliance Director
CASA 99th Annual Meeting
April 23, 2015
Key Goals for Today
• Summarize FSMA Produce Rule
• Share info about the
Produce Safety Alliance (PSA)
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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)
AND
a 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 Profile
for 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 MATCH PROFILE:
Continue to test 5 samples annually
TEN YEAR RE-EVALUATION:
Take 20 samples to establish a new
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
- 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 Exemptions
1. 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 <$500,000
AND
 Sell to qualified end users either:
A. Direct to consumer
B. 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
189,000
Total Produce
Farms
35,000
Covered
154,000
Exempt/
Not covered
Growers may be exempt from the
regulation, but not from the market place.
FSMA Time Frame…in Theory!
Jan
2013
Nov
2013
Public Comment End
November 22, 2013
We are here
Draft Rule Released
Fall
2014
Oct
2015
Very small growers
($25-250K) comply 4 years
Large growers
(>$500K) comply 2 years
20162017
20162018
20162019
Final rule published in
Federal Register
Supplemental Comments
Due Dec. 15th
Small growers
($250-500K)
comply - 3 years
2020+
Add an additional 2
years to each
business size for
compliance with the
water standards
How is it likely is it to impact
fresh produce growers?
How is it likely is it to impact state
food and drug officials?
It Depends!
Which is why it is good to be
talking about it now!
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We are here!
Things you should
know about FSMA
and produce safety!
www.producesafetyalliance.cornell.edu
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Produce Safety Alliance
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
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, comanagement 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
• 10 WCs, 72 calls
• 178 Unique WC Members
• 549 Total WC Members
• 8 Nationwide grower focus groups
Complete: Dec 2012
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
Access to
New Educational Materials
www.gaps.cornell.edu
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Each Decision Tree Portfolio Has…
• Overview of the topic
• Decision tree
• Sample Standard Operating
Procedures (SOPs)
• Sample log sheets
• Template food safety language
Co-Management Information
http://ucfoodsafety.ucdavis.edu/Preharvest/CoManagement_of_Food_Safety_and_Sustainability/
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Training Materials: Foodborne Illness Stories
http://www.lgma.ca.gov/2014/12/dan-sutton-impact-stories-real-people/
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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 ideas
and ways to improve
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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, 315.787.2625
Gretchen L. Wall, M.S., PSA Coordinator, glw53@cornell.edu, 607.255.6806