Current through Register Vol. 50, No. 9, March 1, 2024
RELATES TO: KRS Chapter 260, 21 C.F.R. Part 112
NECESSITY, FUNCTION, AND CONFORMITY: KRS 260.769(1) authorizes
the Department of Agriculture to promulgate administrative regulations for the
efficient administration and enforcement of Kentucky's Produce Safety Rule for
covered produce and covered farms. This administrative regulation establishes a
uniform code for the growing, harvesting, packing, and holding of produce for
human consumption.
Section 1.
Definitions.
(1) "Adulterated" means covered
produce in any growing, harvesting, packing, or holding area that has been
subject to conditions whereby it could have become contaminated with filth or
microorganisms of public health significance, or whereby it could have been
rendered injurious to health.
(2)
"Certificate of compliance" means a certificate issued by the department for
covered farms that are inventoried and subject to regulatory inspection by the
department.
(3) "Certificate of
exemption" means a certificate of exempt status issued by the department
pursuant to Section 5 of this administrative regulation for:
(a) Farms growing only produce that is rarely
consumed raw,
(b) Farms growing
only produce for personal consumption or produced for consumption on the
farm,
(c) Produce that receives
commercial processing that adequately reduces the presence of microorganisms of
public health significance, or
(d)
Farms where, during the previous three (3) year period, a farmers' average of
all produce sales was $25,000 or less (on a rolling basis), adjusted for
inflation using 2011 as the baseline year for calculating the
adjustment.
(4)
"Certificate of qualified exemption" means a certificate of exempt status
issued by the department pursuant to Section 4 of this administrative
regulation.
(5) "Covered farm" is
defined by KRS 260.765(2).
(6)
"Covered produce" is defined by KRS 260.765(1).
(7) "Department" is defined by KRS
260.765(3).
(8) "Egregious
condition" means a practice, condition, or situation that is reasonably likely
to lead to:
(a) Serious adverse health
consequences or death from the consumption of or exposure to covered produce;
or
(b) An imminent public health
hazard if corrective action is not taken immediately.
(9) "Farm" is defined in 21 C.F.R. Part 112
and includes both a Primary Production Farm and a Secondary Activities
Farm.
(10) "Farmer" is defined as
the owner, operator, or agent in charge of a covered farm that is subject to
some or all of the requirements in 21 C.F.R. 112, KRS Chapter 260, and this
administrative regulation.
(11)
"Inspection" means an official regulatory visit conducted by the department for
the purpose verifying compliance with 21 C.F.R. Part 112 , KRS Chapter 260 and
this administrative regulation.
(12) "Microorganisms" means microbial
pathogens of public health significance.
(13) "No Action Indicated" or "NAI" means a
farm inspection classification that indicates the farm is in substantial
compliance, with no violating conditions or only minor violations noted at the
time of inspection.
(14) "Official
Action Indicated" or "OAI" means a farm inspection classification that
indicates one (1) or more egregious violations materially related to food
safety have been cited, or that an uncorrected VAI condition on a previous
inspection has been cited.
(15)
"Qualified exempt farm" means a farm that has met the eligibility requirements
of KRS Chapter 260 for qualified exemption and has been issued a certificate of
qualified exemption from the department.
(16) "Stop Use Order" means an order issued
by the department declaring the cessation of a covered activity; use of a
utensil, piece of equipment, or machinery; water distribution device; or room
or area used for the production, handling, or storage of covered
produce.
(17) "Voluntary Action
Indicated" or "VAI" means a farm inspection classification that indicates a
farm is generally in compliance, with only minor violations cited, which are
not significant enough to pose an imminent health hazard.
Section 2. Right to Scheduled On-site
Verification Visits. The department reserves the right to schedule, at any
reasonable time, an on-site visit to verify if a farm is exempt, covered, or
eligible for a qualified exemption.
Section
3. Produce Farm Survey. All covered farms and farms eligible for
exemption shall be required to annually complete an Informational
Survey.
Section 4. Qualified
Exemption.
(1) A covered farm that meets the
requirements for a qualified exemption may apply for qualified exempt status
with the department by submitting an Application for Qualified
Exemption.
(2) Upon the
department's review of the Application for Qualified Exemption, a farm verified
as having met the requirements for exemption status shall be issued a
certificate of qualified exemption.
(3) A certificate of qualified exemption
shall be non-transferrable.
(4) A
certificate of qualified exemption shall only be issued:
(a) In the name of the applicant;
and
(b) For the FSA location or
locations identified in the application.
(5) Unless otherwise withdrawn, the
certificate of qualified exemption shall be valid for up to three (3)
years.
(6) Qualified exemption
status shall be valid for the balance of the calendar year of issuance
regardless of date, and for the two (2) calendar years ending December 31
thereafter. Renewals for an additional three (3) year period shall be upon
submission of an Application for Qualified Exemption and accompanied by
verification of the successful completion of an FDA-approved training course by
the farmer.
(7) Failure to submit
an updated Application for Qualified Exemption to the Department by the
expiration date noted on the certificate of exemption shall result in
forfeiture of the qualified exemption and the presumption by the Department
that the farm shall be subject to all requirements of the KRS Chapter
260.
(8) All qualified exempt farms
shall be required to complete a yearly evaluation of qualified exemption
status. Once a farm's qualified exempt status changes to covered status, the
farmer shall immediately notify the department.
(9) The epartment shall only withdraw a
qualified exemption as established under 21C.F.R. Part 112 , Subpart R or this
administrative regulation. Withdrawal shall be by written notice to the
farm.
(10) If a farm's qualified
exemption is withdrawn by the department, the farm shall be considered
"covered" and shall be subject to all requirements of 21 C.F.R. Part 112, KRS
Chapter 260, or this administrative regulation.
(11) Any applicant whose application for
qualified exemption has been denied or withdrawn by the department may appeal
the action as established in Section11 of this administrative
regulation.
(12) Any person whose
qualified exemption has been withdrawn by the department may submit a written
request for reinstatement of the qualified exemption.
(13) Within ten (10) days following receipt
of a written request for reinstatement, including a statement signed by the
farmer that, in the farmer's opinion, the condition causing the withdrawal of
qualified exemption has been corrected, the department shall make an
inspection, and if the inspection reveals that the condition causing the
withdrawal has been corrected, the qualified exemption shall be
reinstated.
Section 5.
Certificate of Exemption:
(1) A farm that
meets the requirements for an exemption, as established in KRS Chapter 260 may
apply for a certificate of exempt status with the department by submitting an
Application for Qualified Exemption.
(2) One (1) or more of the requirements
established in paragraphs (a) through (d) of this subsection shall be met for a
Certificate of Exemption.
(a) The farm shall
only grow produce that is rarely consumed raw, specifically including:
asparagus, black beans, great Northern beans, kidney beans, lima beans, navy
beans, pinto beans, beets, garden (roots and tops) beets, sugar beets, cashews,
sour cherries, chickpeas, cocoa beans, coffee beans, collards, sweet corn,
cranberries, dates, dill (seeds and weed), eggplants, figs, ginger, hazelnuts,
horseradish, lentils, okra, peanuts, pecans, peppermint, potatoes, pumpkins,
mature southern field peas (such as black-eyed peas, cowpeas, crowder peas,
purple hull peas, sea island peas, silver peas, and speckled peas), winter
squash, sweet potatoes, and water chestnuts as established in
21 C.F.R. Part
112.2.
(b) Produce grown shall only be used for
personal consumption or produced for consumption on the farm as outlined in 21
C.F.R. Part 112 .2 .
(c) Produce
grown shall receive commercial processing that adequately reduces the presence
of microorganisms of public health significance as established in 21 C.F.R.
Part 112.2.
(d) During the previous
three (3) year period, a farmer's average of all produce sales was $25,000 or
less (on a rolling basis) adjusted for inflation using 2011 as the baseline
year for calculating the adjustment as established in 21 C.F.R. Part 112.4
.
(3) Upon the
department's review of the Application for Qualified Exemption, a farm verified
as having met the requirements for exemption status shall be issued a
Certificate of Exemption.
(4) A
Certificate of Exemption shall be non-transferrable.
(5) A Certificate of Exemption shall only be
issued:
(a) In the name of the applicant;
and
(b) For the FSA location or
locations identified in the application.
(6) Unless otherwise withdrawn, the
Certificate of Exemption shall be valid for as long as the farm remains in
exempt status.
(7) All exempt farms
shall be required to complete a yearly evaluation of exemption status. If a
farm's exempt status changes to covered status, the farmer shall immediately
notify the department.
Section
6. Inspection Frequency, Notices, Records.
(1) Risk prioritization. The department shall
assign a risk prioritization level to each farm based on:
(a) Commodities handled.
(b) Farm acreage.
(c) Annual produce sales.
(d) Farmer attendance at a Produce Safety
Alliance or FDA-approved grower training.
(e) Compliance history.
(f) Participation in an on-farm readiness
review.
(g) Agricultural water
source.
(h) Presence of a farm food
safety plan.
(i) GAP certification
or recent participation in other food safety programs.
(j) Adjacent land use.
(k) Likelihood of wildlife or animal
intrusion.
(l) Geographical
location of the farm.
(2)
Priority designation. Inspection frequencies shall be assigned as follows:
(a) Priority 1 farms shall receive a minimum
of one (1) inspection per year.
(b)
Priority 2 farms shall receive a minimum of one (1) inspection every two (2)
years.
(c) Priority 3 farms shall
receive a minimum of one (1) inspection every three (3) years.
(3) Regardless of a farm's
priority designation, the department shall make as many additional inspections
and re-inspections as are necessary for the enforcement of this administrative
regulation.
(4) Inspection records.
The department representative inspecting a covered farm shall record the
findings on the Produce Farm Inspection Observations Report and shall provide a
copy of the inspection report to the farmer.
(5) Issuances of notices. If an inspection
reveals a violation of this administrative regulation, the department shall
notify the farmer. In the notification, the department shall establish:
(a) The specific violations found;
and
(b) A specific and reasonable
period of time for the correction based on the nature of the violations found
pursuant to this paragraph. The report of inspection shall state:
1. Failure to comply with a notice from the
department, or with a time limit for correction of a violation, shall result in
regulatory action up to and including civil penalties, as established in KRS
Chapter 260, and
2. An opportunity
for appeal from an adverse notice or inspection finding shall be provided if a
written request is filed with the department within ten (10) days following
service of notice.
(6) Service of notice. A notice provided for
under this section shall be properly served if a copy of the Produce Farm
Inspection Observations Report or other notice has been delivered personally to
the farmer, or the notice has been sent by registered or certified mail, return
receipt requested, to the last known address of farmer.
Section 7. Violations and Corrective Action
Plans.
(1) If a farm has committed a violation
of 21 C.F.R. Part 112, KRS Chapter 260, or this administrative regulation, an
opportunity to correct the violation shall be provided in accordance with the
following classifications:
(a) NAI - No
changes in the inspection frequency shall be warranted under this
classification;
(b) VAI - A
follow-up inspection shall be warranted within a period of time not to exceed
the date of the next routine inspection to determine if the violation causing
this classification has been corrected; or
(c) OAI - A follow-up inspection shall be
conducted within a period of time not to exceed thirty (30) days to determine
if the violation causing the classification has been corrected. A farm shall
also be classified as OAI if it continually fails to correct a violation
previously classified under a VAI designation or if an egregious violation is
noted during an inspection.
(2) Upon completion of the inspection, a
recommended classification of NAI, VAI, or OAI and the timeframe for correction
of the violation shall be specified on the Produce Farm Inspection Observations
Report.
(3) A farm that receives an
inspection classification of VAI or OAI shall submit a plan of corrective
action to the department:
(a) VAI: Within
thirty (30) days following the inspection; and
(b) OAI: Within ten (10) days following the
inspection.
(4) Failure
to submit a plan of corrective action to the department within the time frame
established in subsection (3) of this section shall result in the initiation of
enforcement provisions pursuant to KRS Chapter 260 and Section 10 of this
administrative regulation.
(5) If,
during the next inspection, the violation noted on the previous inspection has
not been corrected within the timeframe established in subsection (3) of this
section, the department shall:
(a) Extend the
timeframe for corrective action if the department determines that progress
towards compliance has been made;
(b) Issue a warning letter;
(c) Initiate enforcement provisions pursuant
to Sections 8 and 10 of this administrative regulation; or
(d) Initiate enforcement provisions pursuant
to KRS Chapter 260.
Section 8. Stop Use.
(1) If a duly authorized agent of the
department finds, or has probable cause to believe, that a covered activity or
the continued use of a utensil, piece of equipment or machinery, water
distribution device, or room or area used for the production, handling or
storage of covered produce could result in adulterated product, the department
shall issue a Stop Use Order to the farmer.
(a) The reason for the Stop Use Order shall
be documented on the Notice to Stop Use.
(b) The Notice to Stop Use shall notify all
persons to discontinue a covered activity or use of a utensil, piece of
equipment or machinery, water distribution device, or room or area used for the
production, handling, or storage of covered produce until conditions causing
the Stop Use Order have been corrected and permission for use is given by a
duly authorized agent of the department.
(2) A person shall not, without department
permission, utilize a piece of equipment, room, or area used for the
production, handling, or storage of covered produce for which a Stop Use Order
has been issued.
(3) If the
department has evidence that a farmer has violated the provisions contained in
this section, enforcement provisions shall be initiated pursuant to KRS Chapter
260 and Section 10 of this administrative regulation.
Section 9. Egregious Conditions, Examination,
and Detention of Foods.
(1) The department
shall have the authority to examine and collect water, produce, and
environmental samples as often as necessary for the enforcement of this
administrative regulation.
(2) A
farmer shall take immediate steps to correct any egregious condition.
(3) If a duly authorized agent of the
department finds or has probable cause to believe that covered produce in any
growing, harvesting, packing, or holding area has been subject to conditions
whereby the covered produce could have become contaminated with filth or
microorganisms of public health significance, or whereby the covered produce
could have been rendered injurious to health as established by KRS Chapter 260,
the department shall issue a Stop Movement Order to the farmer.
(a) The reason for the order shall be
documented on the Stop Movement Order.
(b) The Stop Movement Order shall give notice
that the covered produce is, or is suspected of, being contaminated or
injurious to health and notifying all persons not to remove or dispose of the
produce by sale or otherwise until permission for removal, disposal, or
diversion is given by an agent of the department or the court.
(4) The department shall issue a
Notice of Voluntary Destruction to a farmer who elects to voluntarily destroy
covered produce for which a Stop Movement Order has been issued.
(5) If covered produce for which a Stop
Movement Order has been issued can be safely diverted by the farmer for
alternative uses that do not pose a risk to human or animal health, the
department, if requested, shall issue a Notice of Diversion/Change Order to the
farmer.
(6) In all other instances,
the department shall comply with KRS Chapter 260 regarding the disposition of
produce for which a Stop Movement Order was issued.
(7) If the department has evidence that a
farmer has failed to act to correct an egregious condition, enforcement
provisions shall be initiated pursuant to KRS Chapter 260 and Section 10 of
this administrative regulation.
Section 10. Enforcement Provisions.
(1) If the department has substantial reason
to believe that a covered farm has failed to act to correct an egregious
condition; if a farm owner, operator, or agent in charge has interfered with
the department in the performance of its duties after its agents have duly and
officially identified themselves; or if a farm has failed to comply with an OAI
inspection notice within the timeframe granted, the department shall:
(a) Issue a stop work order for that portion
or portions of the covered farm affected by the egregious condition;
(b) Issue a stop movement order; or
(c) Seek civil or criminal penalties under
KRS Chapter 260.
(2) In
all other instances of violation of this administrative regulation, the
department shall serve the registered farm with a written notice specifying the
violation and afford the holder of the registration an opportunity to
correct.
(3) Notices provided for
under this administrative regulation shall be deemed to have been properly
served if:
(a) A copy of the inspection report
or other notice has been delivered personally to the registration holder or the
farm person-in-charge, or
(b) The
notice has been sent by registered or certified mail, return receipt.
(4) Failure to comply with any
provision of this administrative regulation, 21 C.F.R. Part 112, or KRS Chapter
260 shall subject the farmer to civil penalties pursuant to
KRS 260.990.
Section 11. Appeals. All appeals
of KDA determinations shall be in accordance with KRS Chapter 13B.
Section 12. Incorporation by Reference.
(1) The following material is incorporated by
reference:
(a) "Informational Survey",
06/2020;
(b) "Application for
Qualified Exemption", 06/2020;
(c)
"Produce Farm Inspection Observations", 06/2020;
(2) This material may be inspected, copied,
or obtained, subject to applicable copyright law, at the Kentucky Department of
Agriculture, 111 Corporate Drive, Frankfort, Kentucky 40601, Monday through
Friday, 8 a.m. to 4:30 p.m.
STATUTORY AUTHORITY:
KRS
260.020(3),
260.030(1)(d),
260.766, 260.769(1)