The FSMA Fresh
Produce Rule:
Provisions that Apple
Growers Should
Understand!
Dr. Chip Simmons, Elena T. Rogers,
Diane Ducharme, and Dr. Chris Gunter
North Carolina State University,
Department of Horticultural Science
7 Foundational Rules
• Produce Safety
• Preventive Controls for Human Food
• Preventive Controls for Food for Animals
• Foreign Supplier Verification Program
• Third Party Accreditation
• Intentional Adulteration
• Sanitary Transportation of Food
Standards For Growing, Harvesting, Packing And
Holding Of Produce For Human Consumption
Produce Safety Rule
• This regulation focuses on setting federal regulatory
standards for the production, harvest, and handling of
fruits and vegetables, in an effort to prevent microbial
contamination and reduce foodborne illnesses
associated with fresh produce.
• Focuses on routes of microbial contamination
• Science- and risk-based, considers practices and
commodities
Required Training…
Supervisor Training
Under § 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 FDA.
Accordingly, successful completion of training using the
standardized curriculum by your farm personnel (at a
minimum, by one supervisor or responsible party for your
farm) is sufficient to satisfy the requirements of §
112.22(c).
“Approved” Training Curriculum:
Areas Covered
Growing, harvesting, packing
and holding activities:
• Agricultural water
• Biological soil amendments of animal origin
• Domesticated and wild animals
• Equipment, tools, buildings and sanitation
• Worker health and hygiene
• Postharvest Handling and Sanitation
Required Training…
Worker Training and Health and Hygiene
•Establish qualification and training requirements for all
personnel who handle (contact) covered produce or foodcontact surfaces and their supervisors (§§ 112.21,
112.22, and 112.23);
•Require documentation of required training and corrective
actions (§ 112.30); and
•Establish hygienic practices and other measures needed
to prevent persons, including visitors, from contaminating
produce with microorganisms of public health significance
(§§ 112.31, 112.32, and .33).
“Agricultural Water” Under
the Produce Rule
Agricultural Water: in part, water that is intended to, or is likely to,
contact the harvestable portion of covered produce or foodcontact surfaces (§ 112.3(c))
Requires that “Agricultural Water” must be safe and of adequate
sanitary quality for its intended use (§ 112.41)
Establishes requirements for inspection, maintenance, and certain
other actions related to the use of agricultural water, water sources,
and water distribution systems associated with growing, harvesting,
packing, and holding of covered produce (§§ 112.42 and 112.48)
Adapted from the “FSMA Final Rule on Produce Safety: Standards for the Growing, Harvesting,
Packing, and Holding of Produce for Human Consumption Factsheet” available at:
http://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm334114.htm
Agricultural Water
Establish specific requirements for the microbial quality of
agricultural water that is used for certain specified
purposes, including provisions requiring periodic
analytical testing of such water, and requiring certain
actions to be taken when such water is not safe or “of
adequate sanitary quality for its intended use” and/or
does not meet the microbial quality requirements (§§
112.44, 112.45, 112.46, and 112.47)
If a farm chooses to treat agricultural water to meet
relevant requirements for its intended use, establish
requirements related to methods of treatment and
monitoring such treatment (§ 112.43)
Agricultural Water
Require certain records, including documentation of
inspection findings, water testing results, scientific data
or information relied on to support the adequacy of water
treatment methods, treatment monitoring results, scientific
data or information relied on to support microbial die-off or
removal rates or any permitted alternatives to
requirements, time intervals or log reductions applied, and
corrective actions (§ 112.50)
Production Water Concerns
• Many factors impact the quality of water
• Many sources and uses of water on the farm
• Human pathogens can be introduced into water and
contaminate produce during growing activities
Produce safety is impacted by all of these
things!
Slide from Cornell University Produce Safety Alliance curriculum, Version 1.0, “Module 5: Agricultural Water”
Production Water Uses Include:
•
•
•
•
Irrigation
Fertigation
Crop sprays
Cooling
• Frost protection
• Dust abatement
• Other uses where water directly
contacts produce
Slide from Cornell University Produce Safety Alliance curriculum, Version 1.0, “Module 5: Agricultural Water”
Evaluating Risks Related to
Production Water
Three main impact points for produce safety risks related to
production water are:
1. Production water source and quality
• Public water supply, ground water, surface water
• Testing frequency and sampling location
2. Application method
• Water that does not contact the harvestable portion
• Water that contacts the harvestable portion of the crop
3. Timing of application
• At planting or close to harvest
Slide adapted from Cornell University Produce Safety Alliance curriculum, Version 1.0, “Module 5: Agricultural Water”
Probability of Contamination
Higher Risk
Lower Risk
Public Water Supply
Treated
Ground Water
Surface
Water
Open to
Environment
Slide from Cornell University Produce Safety Alliance curriculum, Version 1.0, “Module 5: Agricultural Water”
Many Postharvest Water Uses
• Rinsing/washing
• Commodity movement
(i.e., dump tanks/flumes)
•
•
•
•
•
Cooling
Ice making
Postharvest fungicide and wax
Handwashing
Cleaning and sanitizing
Slide from Cornell University Produce Safety Alliance curriculum, Version 1.0, “Module 5: Agricultural Water”
Agricultural Water Quality
• Two sets of criteria for microbial water quality
– Production Water (pre-harvest)
• Water used in contact with produce during growth
• Irrigation, fertigation, foliar sprays, frost protection
– Postharvest Water
• Water used during or after harvest
• Both criteria based on generic E. coli
– Generic E. coli has long been used to indicate the
presence of fecal contamination in water
Agricultural Water: Geometric Mean (GM)
and Statistical Threshold Value (STV)
agricultural water that is directly applied to growing produce
(other than sprouts) should fall within the following
parameters, or Microbial Water Quality Profile (MWQP):
GM of samples is 126 or less CFU of generic E. coli per
100 mL of water and the STV of samples is 410 CFU or
less of generic E. coli in 100 mL of water
– GM is an average, and therefore represents the central
tendency of the water quality data
– STV reflects the amount of variability in the water quality and
can roughly be described as the value below which 90 percent of
the samples fall
Agricultural Water:
Testing Frequency to Establish a MWQP
Untreated Surface Water – farms are required to conduct
an initial survey, using a minimum of 20 samples, collected
as close as is practicable to harvest over the course of two
to four years
After the initial survey, an annual survey is conducted with
a minimum of 5 samples per year to update the
calculations of GM and STV
– The 5 new samples, plus the previous most recent 15 samples,
create a rolling dataset of 20 samples
Agricultural Water:
Testing Frequency to Establish a MWQP
Untreated Ground Water – farms are required to conduct
an initial survey, using a minimum of 4 samples, collected
as close as is practicable to harvest over the course of one
year
After the initial survey, an annual survey is conducted with
a minimum of 1 sample per year to update the calculations
of GM and STV
– The new sample, plus the previous most recent 3 samples,
create a rolling dataset of 4 samples
Agricultural Water:
Corrective Actions
If the water does not meet established criteria, corrective
actions are required as soon as is practicable, but no
later than the following year:
1. Allowing time for microbes to die off in the field by using a certain
time interval between last irrigation and harvest, but no more than
four consecutive days
2. Allowing time for microbes to die off between harvest and end of
storage, or to be removed during commercial activities such as
washing, within appropriate limits
3. Water Treatment / Mitigation
Agricultural Water: No Detectable E. coli
“Potable Water Quality”
water used for washing hands during and after harvest,
water used on food-contact surfaces, water used to
directly contact produce (including to make ice) during or
after harvest, and water used for sprout irrigation
The rule prohibits use of untreated surface water for any
of these purposes
Agricultural Water:
from Public Supplies or That is Treated
There is no requirement to test agricultural water that is
received from public water systems or supplies
– Provided the farm has Public Water System results or
certificates of compliance demonstrating that the water meets
relevant requirements
There is no requirement to test agricultural water if the
water is treated in compliance with the rule’s treatment
requirements
During Harvest…
Manual vs mechanical harvest
•Mechanical harvest – bruising, broken skin, etc.
•Manual harvest – worker health, hand hygiene,
proper bathroom facilities, proper hand-washing
facilities
•NO FRUIT THAT TOUCHES GROUND!
Portable Handwash
Stations…
FDA Guidance Document currently
available…
NCDA On-Farm Readiness Reviews
• Funding from FDA to 5 states – just over $20M
• Voluntary / Non-regulatory
• Collaboration with NCDA, NCSU, NC Cooperative
Extension, and others
• Collaborators in participating states working on
“tool” for assessment – will be widely available
• Will begin “Spring 2017”
Summary…
Some of the provisions that might be of greatest
interest to NC apple growers:
1. Federally-required training for farm supervisors
2. Water Testing
3. Worker Health and Hygiene
 Availability of some guidance documents
 NC On-Farm Readiness Reviews
Thank you!
NC Fresh Produce Safety Task Force
https://ncfreshproducesafety.ces.ncsu.edu
Chip Simmons - [email protected]
Elena Rogers - [email protected]
Chris Gunter - [email protected]
Lynette Johnston - [email protected]