The document discusses the FDA Food Safety Modernization Act Produce Rule and how it will affect farms. It provides information on: - Coverage of the rule, including which farms and produce are covered based on factors like annual produce sales and whether produce is eaten raw. - Key requirements of the rule for covered farms, including requirements around agricultural water and biological soil amendments. - Exemptions from parts of the rule for qualified exempt farms that meet sales thresholds for direct consumer sales within a certain distance. Requirements for exempt farms include recordkeeping, labeling and annual reviews.

1. FDA Food Safety Moderniza2on Act
Produce Rule
How will it affect your farm business?
Chris Reedy, Industry Training
BioNetwork
February 20, 2016

2. Who here has ever had food poisoning?
Also known as foodborne illness
• 1 in 6 Americans are
affected on a yearly basis
• 128,000 hospitalized
• 3000 die
(CDC)

3. Foodborne diseases
48 million illnesses
each year in the
United States (CDC)
9.4 million are
caused by known
pathogens.
(19 % iden2fied)

4. Public Health Impact for produce
Illness from microbial
contamina2on of produce
(RIA*)
362,059
illnesses per
year
Valued at
$976 million
per year
FDA outbreak surveillance
data from 1996-2014 for
produce-related
outbreaks (QAR*)
173
outbreaks
68 deaths
2013 CDC report
1998-2008
46% of all
foodborne
illnesses
(hospitaliza2on
or death) were
a`ributable to
fresh produce
*Regulatory Impact Analysis * Qualita2ve Assessment of Risk Study

5. Ques2ons?
• Who is familiar with the Food Safety
Moderniza2on Act?
• Who is familiar with the Produce Rule that’s
part of the Food Safety Moderniza2on Act?
• Who thinks the produce rule applies to them?
• Who thinks it doesn’t apply to them?

6. Food Safety
Moderniza2on
Act of 2011
Known as
FSMA
Pronounced ..
(Fĭsma)
Largest reform to our food system since 1938
A shie of focus from reac2on to preven2on including
preven2ng inten2onal contamina2on
More authority to inspect and assure compliance with
inspec2on frequencies based on risk
Mandatory recall authority
Authori2es to strengthen import safety to assure that
US food safety standards are met.
Stronger partnerships with other government
agencies and private en22es.

7. FSMA
focus
areas
Preventa2ve Controls for Human Foods
Preventa2ve Controls for Animal Foods
Accredita2on of 3rd party Auditors for
Foreign Facili2es
Foreign Supplier Verifica2on
Sanitary Transporta2on of Human and
Animal Foods
Inten2onal Adultera2on of Food
Produce Rule
Produce Rule

8. Produce Rule
Implementa2on
Timeline
FDA proposed the rule January 16, 2013
FDA issued a supplemental no2ce Sept.
29,2014 (15,000 unique stakeholder
comments)
Closed comment period December 15, 2014
Finalized into regula2ons in November 13,
2015
Codified in 21 CFR 112 of the federal register
sec2ons 112.1 – 112.213
Finalized into regula2ons in
November 13, 2015

9. Your take away from this
presenta2on!
Iden2fy if my farm is subject to
the FSMA Produce Rule and if
so, to what extent and what
will be my farms responsibili2es
for compliance to that rule.

10. Produce Rule
Coverage
Key
Requirements
Any Ideas on what coverage is based
on?
Any ideas what requirements are going
to address?

11. Will this affect my farm?
Coverage
Covered farms
Covered ac2vi2es
Covered produce
Exemp2ons
Exempt farms
Exempt ac2vi2es
Exempt produce
Addi2onal
Exemp2ons
Qualified Exempt
Farms

12. Covered Farms
A covered farm is one that annually
grosses more than $25,000 in sales
of produce, averaged across a
rolling three-year period, and
adjusted for infla2on (with 2011 as
the baseline year)

13. Covered
Ac2vi2es
Growing, harves2ng,
packing, and holding
covered produce
Strict defini2ons and
specific ac2vi2es
apply
Do not apply to most
food manufacturing
ac2vi2es
making cheese
chopping herbs
Preven2ve Controls
Rule probably will
apply

14. Covered Ac2vi2es
Primary
Produc2on Farm
Secondary
Ac2vi2es Farm

15. Primary
Produc2on Farm
An opera2on under one management in one
general, but not necessarily con2nuous,
physical loca2on
Devoted to the growing of crops, the
harves2ng of crops, the raising of animals, or
any combina2on of these ac2vi2es
Accepted manufacturing/processing ac2vi2es
• Drying/Dehydra2on – grapes to raisins
• Ripening with ethylene gas – tomatoes, bananas, pears
• Packaging Raw Agricultural Commodi2es (RACs) –
raspberries in clam shells (no irradia2on allowed)

16. Secondary
Ac2vi2es Farm
An opera2on not located on a primary produc2on farm
devoted to harves2ng, packing, and/or holding RACs
where the primary produc2on farm(s) provide > 50%
products to be packed & hold > 50% ownership in the
packing opera2on
Harves2ng, Packing, & Holding have specific defini2ons.
See provided list in your packets.

17. Secondary Ac2vi2es Farm Example
If
you are doing ac2vi2es that fit the harves2ng, packing, and
holding defini2ons
but
are doing them at a separate loca2on and under a separate
business structure (like a coopera2vely owned packing shed
that aggregates from mul2ple farms),
then
it is s2ll considered a farm (a “secondary ac2vi2es farm”)
as long as
the primary produc2on farm(s) is providing >50% products to
be packed & hold >50% ownership in the packing opera2on

18. Harves2ng Cooling, Field coring; Filtering; Gathering; Hulling; Removing
stems and husks from; Shelling; Sieing; Threshing; Trimming
of outer leaves, Washing
Packing Sor2ng; Culling, Grading, Weighing or conveying incidental
to packing or re-packing
Holding Fumiga2ng food during storage; Drying/dehydra2ng raw
agricultural commodi2es when the drying/dehydra2ng does
not create a dis2nct commodity (such as drying/dehydra2ng
hay or alfalfa); Blending of the same raw agricultural
commodity; and Breaking down pallets.
Acceptable ac2vi2es at Secondary Farms

19. Food Hubs
Off-farm aggrega2on
at loca2on not owned
by the farmers
Packing and holding
ac2vi2es trigger
Preven2ve Controls Rule
of food manufacturers
On-farm aggrega2on,
not manufacturing
Most likely will not trigger
the Preventa2ve Control
Rule of food
manufacturers regardless
of who grew the product

20. Anyone here sell crops through a CSA, Roadside
stand or Tailgate?

21. Direct-to-Consumer Sales Programs
• Congressional intent was to s2ll consider this
farm ac2vity and not a food manufacturing
ac2vity regardless of who grew the crops.
• FDA plans to issue a separate rule on this topic
CSA
Roadside
stands
Farmers
markets

22. Covered
Produce
Eaten Raw
Exempt
Produce
Rarely
Eaten Raw

23. Covered Produce
Subject to the
Produce Rule
Raw Agricultural Commodity
Unprocessed state
Usually consumed raw
See provided list -
Non-exhaus2ve

24. Exempt Produce
Not covered
Not subject to
these rules
Unprocessed state
Usually not
consumed raw
See provided list -
Non-exhaus2ve

25. Addi2onal
Exemp2ons
Personal or on Farm
consump2on
Produce that has been
processed and is not longer in
its natural state
Produce des2ned as an
ingredient in a packaged
product that u2lizes a ‘kill step’
Low Risk On-Farm
Manufacturing/Processing/
Packing/Holding

26. Qualified Exempt Farms
<$500,000 in sales of all
food (not just produce)
based on an average of
the previous three years
and adjusted for infla2on
Your sales to “qualified
end users” exceed your
sales to all other
purchasers
&
See provided FDA Produce Coverage Flow Chart
Farms must meet both of these requirements

27. Qualified End User
• A qualified end user is the consumer of the
food
o An individual, not a business
o Restaurant
o Retail food establishment (e.g. grocery store)
o Located either in same State or same Indian
reserva2on as the farm that produced the food or
< 275 miles from the farm

28. Qualified Exemp2on Example
• Sales of all food (Gross) = $371,000
• Wholesale crops to be made into other products = $185,000
o Soy – Animal Feed – $85,000
o Corn - Animal Feed - $100,000
• Direct to qualified end users = $186,000
o Livestock
Ø Beef - $60,000 to Grocery stores under your brand.
o Produce – $126,000
Ø CSA - $50,000 - local
Ø Grocery Store - $50,000 – Ingles <275 miles away
Ø Restaurants - $16,000
Ø Farmers markets - $10,000 – local
• 186,000/371,000 = 50.13% to qualified users
• All sales within 275 miles of the farm.

29. 275 mile radius of Asheville
Asheville
Cincinna2
OH
Charlo`esville
VA
Savannah
GA
Birmingham
AL
Nashville
TN
Louisville
KY

30. Exemp2on Criteria Review
• < $500,000 in all food gross sales
• > 50 % of those sales go to Qualified end users
o Direct to consumer
Ø CSA
Ø Farmers Market
Ø Restaurant
Ø Grocery store
• Within the same state or reserva2on or < than
275 miles away

31. Modified Requirements
Labeling Records
Compliance
Withdrawal of
Qualified
Exemp2ons

32. Labeling
Name and
complete
business
address of the
farm where
the produce
was grown
If label is
required
If label
not
required
By January 1st, 2020
<$250,000 Sales –By 1-26-2020
<$500,000 Sales –By 1-26-2019
Displayed on a label,
poster, sign, placard, or
documents delivered
contemporaneously with
the produce in the normal
course of business

33. Records
• Records proving qualified exemp2ons
o Sales are below the sales threshold
o Selling more to qualified end users than not
o Qualified end user within 275 miles of the farm
• Retained for 3 years and available within 24
hours of request.
• General requirements for records
o Detailed
o Accurate
o Legible
o Dated and signed
o Original or true copies

34. Compliance
Qualified exempt farms are
subject to the same
compliance and enforcement
provisions as covered farms
Pu{ng adulterated food into
interstate commerce is also a
prohibited act, regardless of
whether the farm is covered
by the Produce Rule or not
Keep wri`en record that
reflects an annual review and
verifica2on of the farm’s
con2nued eligibility for the
qualified exemp2on
Annual Review record needs
to happen a year before the
compliance date

35. Withdrawal (and reinstatement) of a
qualified exemp2on
Can withdraw due to an
ac2ve foodborne illness
outbreak directly linked
to your farm
Last resort with the
ability to be reinstated

36. Further considera2ons
Organic and GAP cer2fied
farms have advantages in
compliance since many
are already follow some
of the full requirements
Buyers may require
vendors to fully follow
the rules or be third party
audited

37. Ques2ons?
Remember – If you meet the qualified exempt farm
requirements, you follow the modified requirements
not the full rules

38. Ques2on?
Any ideas of what the key requirements are for
farms that are fully subject to the rule?

39. Key
Requirements
of the
Produce Rule
for Non-
exempt farms
Agricultural Water
Biological Soil Amendments
Personnel Qualifica2ons and Training
Health and Hygiene
Equipment, Tools & Buildings
Domes2cated and Wild Animals
Growing, Harves2ng, Packing & Holding
Recording Keeping

40. Agricultural
Water
Requirements
FDA Agricultural water defini2on
Inspec2on & regular maintenance of the system
Microbial Water Criteria
Microbial Die-off
Tes2ng
Compliance
Records

41. FDA
Agricultural
water
defini2on
Means water
used in covered
ac2vi2es on
covered produce
where water is
intended to, or is
likely to, contact
covered produce
or food contact
surfaces
Covered produce
Food contact surfaces –
knives, harvest bins, etc.
Prep for crop sprays
Wash water
Water used for cooling or
preven2ng dehydra2on
Making ice

42. Requirements don’t apply if the
defini2on is not met
Drip irriga2on of tree
crops is not intended to
or is unlikely to contact
covered produce (Apples)
Drip irriga2on of a
covered root crop like
carrots would apply. It is
intended to contact the
produce.

43. Inspec2on &
regular
maintenance
of the
system –
‘must
inspect
annually’
Nature of each agricultural water source
(River, pond, well, cistern)
Extent of your control over it
Degree of protec2on each source has
Adjacent and nearby land use that may
impact water quality
Likelihood of introduc2on of reasonably
foreseeable hazards of upstream water user

44. Microbial
Water Criteria
Establishes farm
use water quality
standards
E. coli (strain O157:H7)

45. Two Dis2nct Microbial
Water Quality Standards
Used during growing
ac2vi2es where it is
intended or likely to
contact covered produce
Used to irrigate sprouts, for
food contact surfaces, or
hand washing in harvest/
post harvest handling

46. Water
Used during growing
ac2vi2es
Likely intended to contact
covered (likely to be eaten
raw) produce
A geometric mean (GM) of
your agricultural water
samples of 126 or less colony
forming units (CFU) of
generic E. coli per 100 mL of
water
A sta2s2cal threshold
value (STV) of your
agricultural water samples
of 410 or less CFU of
generic E. coli per 100 mL
of water.

47. If tes2ng
sa2sfies both
criteria
water can be
used as you see
fit - covered
produce or not

48. Water (used for)
Sprout irriga2on
Post harvest washing
Cleaning food contact
surfaces
Hand washing during
harvest & postharvest
handling
No detectable
generic E. coli
per 100mL
Prohibits the use of
untreated surface
water for any of these
harvest and post-
harvest purposes

49. Not sa2sfying both
criteria then
Correc2ve Ac2ons
Switching source
Irriga2on method –
not intended to
contact covered
produce
Applying the microbial
die-off rate

50. Microbial
Die-off
Indicated number of days between applica2on
and harvest
Based on test results of the water source
sampled
Based on 0.5 log reduc2on/day
Due to sunlight, moisture, temperature, pH,
etc.
FDA to provide guidance
If takes > 4 days to achieve then another
source must be used

51. Municipal
Water
Tes2ng not required if certs are on file
Surface
water
20 samples over 4 years as close to harvest as
prac2cal to create baseline
Thereaeer, 5 samples yearly plus 15 most recent to create
your 20 group sample
Ground
water
4 samples yearly first year to create baseline
Thereaeer, 1 sample yearly plus 3 most recent to create your
4 group sample
If generic E coli is found in a single annual sample, test must
resume at least 4 2mes per year
Water Quality Tes2ng

52. Tes2ng
methods
EPA method
1603 or Modified
mTEC Test
Or equivalent

53. Ag Water Compliance
Very small businesses
<$250,000 produce
sales
6 years to
comply
Small businesses
<$500,000 produce sales
5 years to
comply
Other businesses
>$500,000 produce
sales
4 years to
comply

54. Record
Keeping &
Documen2ng
Water source inspec2on
Water test results
Data to support alterna2ves
Use of microbial die-off rate
Certs from municipal water test

55. Biological
Soil
Amendments
(BSAs)
Defini2on
Standards for Treated BSAs
Standards for Untreated
BSAs
Records

56. Biological Soil Amendments
Soil amendments that consist par2ally
or en2rely of materials of animal
origin, so that includes but is not
limited to raw and composted manure
Agricultural Teas included in this category

57. Standards
for
Treated
BSAs
Processed to adequately reduce
microorganisms
Must use scien2fically valid physical,
chemical or biological process
Treated BSAs can be applied without
restric2ve applica2on intervals
Applied in a manner that minimizes the
poten2al for contact with covered produce

58. Sta2c
Compos2ng
Maintains aerobic condi2ons
At a minimum of 131° F
For 3 consecu2ve days
Cured adequately aeerward
Turned
Compos2ng
Maintains aerobic condi2ons
Minimum of 131° F
15 non-consecu2ve days
Minimum of 5 turnings
Cured adequately aeerward
Compos2ng
21 CFR 112.54.b.1
21 CFR 112.54.b.2

59. Standards
for
Untreated
BSAs
Untreated soil amendments containing any
animal byproducts – manure, feather meal, etc.
No chance that covered produce contact, no
interval is required.
FDA originally suggested a 9 month interval
between applica2on and harvest (chance of
contact with covered produce)
FDA performing risk assessment over the next
5 – 10 years
FDA states - prudent interim measure – Na2onal
Organic Program standards – 90 - 120 days
depending on applica2on method

60. Record
Keeping
documenta2on
Documen2ng the validity of
treatment process (also for 3rd
par2es)
Documenta2on of handling,
conveyance and storage to minimize
cross contamina2on
Compos2ng – documenta2on of
process monitoring used including
monitoring of control factors like
days and temperature

61. Farm workers
Personnel
Qualifica2on
and Training
Health and
Hygiene

62. Personnel
Qualifica2on
and Training
Employees involved
in growing,
harves2ng, packing,
or holding covered
produce
Principles of food hygiene and
food safety
Health and personal hygiene
Harvester will need
training to recognize
Produce that must not be
harvested
Inspec2on and cleaning of
harvest containers
Correc2ve ac2ons with harvest
containers and equipment
Supervisors
Must complete Food Safety
training with Produce Safety
Alliance standardized curriculum

63. Standardized
Training
Curriculum
Produce
Safety Alliance
at Cornell
University
Developing a
Standardized
Curriculum
Probably delivered
through NC Extension
or NC Department of Ag
Trainings Documented and
records retained
Include date, topics and
person trained

64. Health
and
Hygiene
Farms must
take measures
to protect
against
contamina2on
from …
Personnel
Visitors

65. Hygiene
Prac2ces
around
covered
produce
Polices and
procedures
needed
Personal Cleanliness – Clothes
Hand washing – When and how
Avoiding contact with other animals
Removing jewelry
Ea2ng/Chewing Gum/Use of tobacco
products around covered produce

66. Visitors -
around
covered
produce
Preven2on program that
makes visitors aware of
policies and procedures
to protect covered crops
Must make toilet and
hand-washing facili2es
accessible to visitors

67. Equipment,
Tools and
Buildings
considera2ons
include:
Greenhouses are
included
Sanita2on schedule and wri`en sanita2on standard
opera2ng procedures (SSOPs)
Inspected, maintained and cleaned when appropriate
Pest control
Toilets and hand-washing facili2es
Sewage/Waste Disposal
Handling Animal Li`er
Cleaning and sani2zing equipment used in covered
harves2ng, packing and holding ac2vi2es

68. Domes2cated
and Wild
Animals
Assess relevant areas for evidence of contamina2on
Assessments on contamina2on and crops
disposi2on will need to be made if animals are
observed or crops destroyed
Excluding domes2cated animals from fully enclosed
buildings where covered produce is grown, handled
or packing material is stored
Guide dogs are allowed in some areas if it is unlikely
it will result in contamina2on

69. Growing,
Harves2ng,
Packing
and
Holding
Ac2vi2es
Measures to avoid cross
contamina2on between
covered (le`uce) and exempt
crops (asparagus)
Storage procedures –
covered produce on
top
Measures to iden2fy and not
harvest covered produce that is
likely to be contaminated
Training on harvest
prac2ces
Methods of handling harvested
produce to prevent
contamina2on
Ensure transport
vehicles are cleaned
and sani2zed
Using packaging, whether
cleanable or single use, unlikely
to support the growth or
transfer of bacteria
Wash, rinse and
sani2ze harvest bins

70. General
Record
keeping
requirements
Name and loca2on of farm
Date and ac2vity documented
Actual Values/observa2ons of monitoring
Descrip2on of covered produce and lot number
Loca2on of specific field or packing shed
Created at the 2me of the ac2vity
Accurate and legible
Dated and signed by person who performed the ac2vity
Held for 2 years unless used in income exemp2on status then 3 years
Available in 24 hours if requested by inspectors

71. Records
review
Records pertaining to the farms exempt status
Training
Water test
Water treatment
Applica2on interval
Compos2ng controls
Cleaning and sani2zing logs

72. Compliance
< $25,000 in produce sales, fully exempt
<$250,000 Gross – Very Small Businesses – January 2020
<$500,000 Gross –Small Businesses – January 2019
>$500,000 Gross –Other Businesses – January 2018
Ag Water compliance add 2 years to each category
Sprouts subtract one year from each business category

73. Guidance
forthcoming
Implementa2on and
Compliance Guide
Sprout Guidance
Small En2ty Compliance
Guide
Updated GAPs Guidance

74. FDA on
Farm
Inspec2ons
Targeted based on Risk
Developing a working plan regarding
rou2ne inspec2ons
Compliance will come through 3rd party
audits and supply chain management
from farms and their customers
As 3rd party audi2ng will likely drive
compliance, FDA will look to improve
the rigor and reliability of those audits

75. Educa2on, Outreach, Training and
Technical Assistance Partnerships
• Alliances
o Produce Safety Alliance
o Sprout Safety Alliance
o Food Safety Preven2ve Controls Alliance
• FDA/USDA-NIFA Collabora2on: Na2onal Food Safety
Training, Educa2on, Extension, Outreach, and
Technical Assistance Program
• Training through Coopera2ve Agreements

76. Ques2ons?