Current through Register Vol. 50, No. 6, December 1, 2023
RELATES TO: KRS Chapter 217B, 260.850-260.869,
7 U.S.C.
1639p,
7
C.F.R. Part 990
NECESSITY, FUNCTION, AND CONFORMITY:
KRS
260.862(1) authorizes the
department to promulgate administrative regulations for a Hemp Licensing
Program in the Commonwealth of Kentucky.
KRS
260.862(1)(a) authorizes the
department to license persons who wish to participate in a Hemp Licensing
Program by cultivating, handling, processing, or marketing hemp.
KRS
260.862(1)(c) authorizes the
department to prescribe sampling and testing procedures to ensure that hemp and
hemp products cultivated, handled, processed, or marketed do not exceed the
federal law. This administrative regulation establishes procedures and
requirements for sampling and THC testing, and establishes procedures for the
movement or disposal of hemp following the completion of THC testing.
Section 1. Definitions.
(1) "Acceptable Hemp THC Level" means the sum
of the Measurement of Uncertainty plus the 0.300% delta-9-THC limit on a dry
weight basis established in federal law,
7
U.S.C. 1639, and KRS Chapter 260.
(2) "Cannabis":
(a) Means the plant that, depending on its
THC concentration level, is defined as either "hemp" or "marijuana." Cannabis
is a genus of flowering plants in the family Cannabaceae of which Cannabis
sativa is a species, and Cannabis indica and Cannabis ruderalis or subspecies
thereof. Cannabis includes all parts of the plant, whether growing or not,
including its seeds, resin, compounds, salts, derivatives, and extracts;
and
(b) Does not mean a "publicly
marketable hemp product," as defined by 302 KAR 50:021, Section
1(37).
(3) "CBD" means
cannabidiol.
(4) "Certified seed":
(a) Means the progeny of breeder, foundation,
or registered seed handled to maintain satisfactory genetic purity and varietal
identity and certified to AOSCA (Association of Official Seed Certifying
Agencies) standards and having an official AOSCA seed label; and
(b) Does not include a state's THC compliance
verification program.
(5) "Decarboxylated" means the completion of
the chemical reaction that converts delta-9-THC-acid into delta-9-THC, the
intoxicating component of cannabis. The decarboxylated value is also calculated
using a conversion formula that sums delta-9-THC and eighty-seven and seven
tenths (87.7) percent of delta-9-THC-acid.
(6) "Delta-9-THC" means
delta-9-tetrahydrocannabinol concentration (the primary intoxicating component
of cannabis). For compliance purposes, all delta-9-THC concentrations are
measured post- decarboxylation or by another method which includes both
delta-9-THC and delta-9-THCA (also known as total THC).
(7) "Department" or "KDA" is defined by
KRS
260.850(3).
(8) "Hemp" or "industrial hemp" is defined by
KRS
260.850(5).
(9) "Hemp transplants" means hemp seedlings,
rooted cuttings, immature plants produced from tissue culture, or other means
of reproduction, which are not harvested, but transplanted into a large
container or field to mature for harvest. The movement of transplants from
their original location to the crop production location is not considered a
harvest.
(10) "Inspector" means an
employee or other representative of the department who has been properly
trained by the department to collect samples and perform inspections.
(11) "Lot" means a contiguous area in a
field, greenhouse, or indoor growing structure containing the same variety or
strain of hemp throughout.
(12)
"Measurement of uncertainty" means the parameter, associated with the result of
a measurement that characterizes the dispersion of the values that could
reasonably be attributed to the particular quantity subject to the
measurement.
(13) "MSU BVC" means
the Breathitt Veterinary Center at the Murray State University in
Hopkinsville.
(14) "Person" means
an individual or business entity.
(15) "Post-harvest sample" means a sample
taken from the harvested hemp from a particular lot's harvest in accordance
with the procedures as established in this administrative regulation. The
entire lot's harvest is in the same form (for example, intact-plant, or ground
materials), homogenous, and not mixed with non-hemp materials or hemp from
another lot.
(16) "Pre-harvest
sample" means a composite, representative portion from living plants in a hemp
lot collected in accordance with the procedures as established in this
administrative regulation.
(17)
"Program" means the department's Hemp Licensing Program.
(18) "Propagule" means a plant or plant part
that can be utilized to grow a new plant.
(19) "UK DRS" means the Division of
Regulatory Services at the University of Kentucky College of Agriculture, Food,
and Environment in Lexington.
Section
2. Procedures for Inspection and Sample-Collection Visits.
(1) A hemp plant shall not be harvested from
any lot before a department inspector completes an inspection and
sample-collection visit.
(2) The
licensed grower shall submit to the department a completed Harvest Report form,
as incorporated by reference in
302 KAR
50:080, at least fifteen (15) days prior to the
grower's expected harvest date.
(3)
Upon receiving a completed Harvest Report form, the department shall contact
the licensed grower to schedule an inspection and sample-collection visit for a
specific time on a date that is not later than the grower's expected harvest
date.
(4) The licensed grower, or
the grower's authorized representative, shall be present during the inspection
and sample-collection visit.
(5)
During the inspection and sample-collection visit, the licensed grower shall
provide to the inspector, complete and unrestricted access to all hemp and
other cannabis plants, whether growing or harvested; all land, buildings, and
other structures used for the cultivation and storage of hemp and other
cannabis plants; and all locations listed in the Hemp Grower License.
(6) During the inspection and
sample-collection visit, the inspector shall perform a visual inspection of
each location listed in the Hemp Grower License in order to verify the GPS
coordinates and look for evidence that hemp plants or other cannabis plants
were harvested without authorization prior to the inspector's inspection and
sample-collection visit or any other suspicious circumstance.
(7) The licensed grower shall complete the
harvest of the crop from a lot not more than thirty (30) days following the
date of the inspection and sample-collection visit.
(8) If the licensed grower fails to complete
the harvest of the crop from a lot within thirty (30) days following the date
of sample collection, then the licensed grower shall submit a new Harvest
Report and may be required to pay a secondary pre-harvest sample fee
established in
302 KAR
50:060.
(9) Floral material shall not be moved
outside the Commonwealth, nor moved beyond a processor; nor commingled,
extracted, converted into a consumer-ready product, enter commerce, until the
department releases the material in writing.
Section 3. Standards and Procedures for
Performance Based Sampling.
(1) The
department intends to sample and test every lot of hemp prior to harvest every
year. If it is not feasible to sample and test every lot, then the department
may implement these performance-based sampling procedures.
(2) The goal is to ensure at a confidence
level of ninety-five (95) percent that no more than one (1) percent of the
plants in each lot will exceed the acceptable THC level, and that a
representative sample is collected that represents a homogenous composition of
the lot.
(3) A lot of hemp shall
only be eligible for performance based sampling consideration if the licensee
maintains records documenting the variety or cultivar's compliance with the
acceptable THC concentration.
(4)
The transfer of hemp transplants from one (1) location to the location at which
the plants will grow to maturity and from which the plants will be harvested
shall not be considered to be a harvest. Hemp transplants shall not be subject
to sampling before the plants are transferred to the location at which these
plants will grow to maturity. Instead, the mature crop produced from hemp
transplants shall be subject to sampling and testing.
(5) A hemp licensee who has met all four (4)
of the compliance history requirements as established in this subsection may
not be subject to the sampling and testing requirement in the current year:
(a) Produced hemp for the past three (3)
consecutive years;
(b) Underwent
THC testing by the department each of those three (3) years;
(c) Received THC testing results below the
acceptable THC level (total THC not more than 0.3%) each of those three (3)
years; and
(d) Currently growing
the same variety(s) or cultivar(s) as in the previous three (3)
years.
(6) Hemp crops
which were planted with known Certified seed varieties for grain or fiber, and
which are to be harvested only for grain or fiber (with no leaf or floral
material harvested) may not be subject to the sampling and testing requirement.
Previous testing of those varieties in Kentucky by the department revealed that
only nine (9) of 179 lots (five (5) percent) tested above the acceptable hemp
THC level. At least fifty (50) percent of all lots produced from these
varieties shall be sampled each year on a random basis.
(7) Hemp varieties appearing on the
department's Summary of Varieties list available at
https://www.kyagr.com/marketing/documents/HEMP_LH_Summary_of_Varieties_List.pdf
and that have been tested below the acceptable THC level at least ninety (90)
percent of the time may be subject to a lower frequency of sampling and
testing. At least fifty (50) percent of all lots produced from these varieties
shall be sampled each year on a random basis.
Section 4. Procedure for Collecting Samples.
(1) The inspector shall use the following
equipment and supplies:
(a) An Inspection and
Sample Collection form;
(b) Alcohol
wipes;
(c) Pruning
shears;
(d) Paper sample-collection
bags;
(e) A permanent
marker;
(f) Security tape or a
stapler;
(g) A GPS unit, or a
device with GPS-capable technology;
(h) Nitrile disposable gloves; and
(i) A ruler.
(2) The inspector shall take cuttings from
five (5) plants in each lot to make up a composite sample for that lot. The
number of plants selected to form a composite sample was calculated using the
Codex Alimentarius Recommended Methods of Sampling for the Determination of
Pesticide Residues for Compliance with MRLS CAC/GL 33-1999 available at
https://apeda.gov.in/apedawebsite/Announcements/CODEX_method_for_sampling_for_determination_of_pesticides.pdf.
In 2019, Kentucky's hemp testing program showed that 43% of the pre-harvest
samples were above 0.30% THC; therefore "I" is equal to 0.43. For a confidence
level of ninety-five (95) percent, the minimum plant number required shall be
three (3). A lot from a thousand-acre field would require five and three-tenths
(5.3) plants.
(3) The inspector
shall select the individual plants to be sampled from each lot by selecting at
random at least five (5) plants that appear to be representative of the
composition of the lot and avoiding selecting plants that are close to the
perimeter of the lot.
(4) From each
individual plant selected for sampling, the inspector shall cut the highest
twenty (20) centimeters from the plant's primary stem of female flower. The
inspector shall not remove seed, stem, or other material from the sample that
is cut from the plant.
(5) The
inspector shall place the cuttings from the lot into a paper sample-collection
bag, shut the bag by folding over its top, and secure the fold with security
tape or a stapler.
(6) Using a
permanent marker, the inspector shall write on the sealed paper sample
collection bag the Sample ID consistent with:
(a) The last four (4) digits of the Grower
License number,
(b) The date, in
MMDDYY format; and
(c) A two (2)
digit sample number assigned by the inspector.
(d) Example: For Grower License 21_1234, with
a sample collected on October 15, 2020, from the third lot sampled by the
inspector on that date, the Sample ID is 1234-101520-03.
(7) The inspector shall complete the
Inspection and Sample Collection form by entering:
(a) The licensed grower's name and contact
information;
(b) The address where
the lot is located;
(c) The Grower
License number;
(d) The inspector's
name;
(e) The date of the
inspection and sample collection visit; and
(f) For each sample collected, the Location
ID, the Sample ID, the hemp variety or strain name, and a description of the
crop.
(8) Following the
completion of the inspection and sample-collection visit, the inspector shall
deliver the sealed sample-collection bag to the department's designated drying
facility.
(9) The department shall
not unseal sample-collection bags during the drying process.
Section 5. Procedure for THC
Testing.
(1) THC testing shall be completed by
a Drug Enforcement Administration-registered testing lab designated by the
department.
(2) Upon receipt of a
sealed sample-collection bag from the department, the laboratory shall receive,
prepare, and release hemp samples in accordance with the UK DRS SOP# HM-LB-001
(Procedures for Receiving, Preparing and Releasing Hemp Samples) or MSU BVC SOP
# TOX WIN 0042 (Hemp Receiving) and MSU BVC SOP # TOX WIN 0043 (Hemp Storage
and Destruction), as applicable.
(3) Hemp material not used by the laboratory
for delta-9-THC testing shall be stored as a retained sample.
(4) The laboratory shall measure delta-9-THC
content, including both delta-9-THC and delta-9-THCA, on a dry weight basis in
accordance with the UK DRS SOP# HM-MT-001 (Procedures for Measuring THC Content
in Hemp by Gas Chromotography with Flame Ionization Detection (GC/FID)) or MSU
BVC SOP # TOX WIN 0069 (Hemp Potency), as applicable, including the Measurement
of Uncertainty.
(5) A person shall
not add to, amend, or in any way alter the composition of the retained
sample.
Section 6.
Post-testing Actions.
(1) Not later than sixty
(60) after the date of the inspection and sample-collection visit, the
department shall notify the licensed grower of the results of the THC test
results and the grower's eligibility to move the harvested materials into
commerce.
(2) For the purpose of
determining if a test result is compliant with the definition of hemp (0.3000%
delta-9-THC on a dry-weight basis), the department shall evaluate it against
the Acceptable Hemp THC Level that is applicable for the current year (that is,
0.300% delta-9-THC on a dry-weight basis plus the Measurement of
Uncertainty).
(3) A sample from a
lot with a measured THC concentration not exceeding the Acceptable Hemp THC
Level shall be deemed compliant (conforming to the legal definition of
hemp).
(4) A sample from a lot with
a measured THC concentration exceeding the Acceptable Hemp THC Level shall be
deemed non-compliant.
(5) Within
seven (7) days of receiving notice of a measured THC concentration that exceeds
the Acceptable Hemp THC Level, but is less than 1.000%, the Licensed Grower
shall consent to the destruction of all cannabis from that lot or he or she may
request remediation and a post-harvest re-test in accordance with the
procedures established in Section 7 of this administrative
regulation.
(6) The retest fee
shall be paid in an amount established in
302 KAR
50:060.
(7) Samples with a measured THC concentration
of 1.000% or greater shall not be eligible for a post-harvest retest and shall
be destroyed. A licensee who refuses to comply with a destruction order shall
be subject to the license suspension and revocation proceedings set forth in
302 KAR 50:021 or 302 KAR 50:031, as appropriate.
(8) The sample for a retest shall be
collected on a date determined by the department.
(9) Samples with a measured THC concentration
of 3.000% or greater shall be grounds for license suspension and revocation
proceedings set forth in 302 KAR 50:021.
Section 7. Procedure for Collecting Samples
for Post-harvest Retests of Remediated Material.
(1) The inspector shall use the following
equipment and supplies:
(a) An Inspection and
Sample Collection form;
(b) Alcohol
wipes;
(c) Pruning
shears;
(d) Paper sample-collection
bags for wet samples;
(e) Plastic
sample-collection bags for dry samples;
(f) A permanent marker;
(g) Security tape or a stapler;
(h) A GPS unit, or a device with GPS-capable
technology; and
(i) Nitrile
disposable gloves.
(2)
The material selected for Post-Harvest Sampling from this lot shall be
determined by the inspector, not the grower.
(3) The inspector shall perform a visual
inspection to verify that the harvested material is in a homogenous state. If
the harvested material is not in a homogenous state, then the inspector shall
notify the Hemp Program Manager and convey any instructions the Hemp Program
Manager may designate to undertake additional remediation steps to bring the
entire harvest into a homogenous state. If the license holder refuses or fails
to undertake the designated activities, he or she shall be deemed to have
waived any right to request a post-harvest retest and the material shall be
designated for disposal.
(4)
Harvested material selected for Post-Harvest Sampling shall be taken following
remediation by grinding the plant into biomass or removing and disposing of all
leaf and flower, in accordance with the instructions established in paragraphs
(a) and (b) of this subsection.
(a) For ground
plant post-harvest samples:
1. Ensure that the
entire harvest is accounted for and in the same form. All harvested material
whether whole plant or floral material only shall be ground with no intact
plants or whole flowers remaining from that harvest;
2. Sample material from bag or container
without removing seed, stem, or other material;
3. Sample from a minimum of five (5)
locations within the containers for at least one (1) cup of material from the
lot;
4. Place the complete sample
in a plastic sample container; and
5. Seal the plastic sample
container.
(b) For
Post-Harvest Samples following the removal and disposal of leaf and flower:
1. Ensure that the entire harvest is
accounted for and in the same form (grain or stalk);
2. Sample material from bag, bale, or
container without removing seed, stem, or other material;
3. Sample from a minimum of five (5)
locations within the containers, collecting at least one (1) cup of material
from the lot;
4. Place the complete
sample in a plastic sample container; and
5. Seal the plastic sample
container.
(5) Post-Harvest Samples of non-remediated
crops is not recommended, but if the grower requests and pays for a
Post-Harvest Sample of harvested intact plants, the sampling will be conducted
according to the instructions established in paragraphs (a) through (e) of this
subsection:
(a) Ensure that the entire harvest
is accounted for and in the same form (intact plants);
(b) Clip the top twenty (20) cm of hemp
plant, primary stem, including female floral material, without removing seed,
stem, or other material;
(c) Take
cuttings from at least five (5) hemp plants within the harvest's storage or
drying area at the discretion of the inspector;
(d) Place the complete sample in a paper bag;
and
(e) Seal the paper bag by
folding over the top once and stapling to keep closed.
(6) The inspector shall place the cuttings or
composite sample from the lot into a sample collection bag and secure the bag
with security tape or staples.
(7)
Using a permanent marker, the inspector shall write on the sealed
sample-collection bag the Sample ID consistent with the following format:
(a) The last four (4) digits of the Grower
License number;
(b) The date, in
MMDDYY format;
(c) A two (2) digit
sample number assigned by the inspector; and
(d) Example: For Grower License 21_1234, with
a sample collected on October 15, 2020, from the third lot sampled by the
inspector on that date, the Sample ID is 1234-101520-03.
(8) The inspector shall complete the
Inspection and Sample Collection form by entering:
(a) The licensed grower's name and contact
information;
(b) The address where
the lot was grown and where it is currently located;
(c) The Grower License number;
(d) The inspector's name;
(e) The date of the inspection and sample
collection visit; and
(f) For each
sample collected, the Location ID, the Sample ID, the hemp variety or strain
name, and a description of the crop.
(9) Following the completion of the
inspection and sample-collection visit, the inspector shall deliver the sealed
sample-collection bag to the department's designated drying facility.
(10) The department shall not unseal
sample-collection bags during the drying process.
(11) The procedure for THC testing used by UK
DRS shall be the same for post-harvest retests as those established in Section
5 of this administrative regulation.
(12) A lot having a post-harvest sample with
a measured THC concentration exceeding the Acceptable Hemp THC Level shall be
deemed non-compliant and designated for disposal.
Section 8. Disposal of Non-compliant
Harvested Materials.
(1) If a lot is
designated for mandatory disposal, then the department shall ensure that all
leaf material and floral material from that lot is disposed of using one (1) of
the procedures established in this Section of this administrative regulation.
The costs of disposal, if any are incurred by the department, shall be charged
to the license holder.
(2) Disposal
by on-site destruction with department supervision. Without removing the
harvested material from the license holder's premises (or other licensed
premises where the harvested material is located), a department employee shall
personally observe the harvested material's destruction (the act of rendering
it into a useless and non-retrievable state) using one (1) of these methods:
(a) By grinding it up and incorporating it
into the soil; or
(b) By controlled
incineration.
(3)
Disposal by on-farm transfer to a person who is registered or authorized by the
department to accept controlled substances for the purposes of destruction. At
the premises of the license holder (or other licensed premises where the
harvested material is located), a department employee shall load, or observe
the loading, of the harvested material until the transfer is
complete.
(4) Disposal by vehicle
transport to a department-approved location.
(a) Prior to the transport: At the premises
of the license holder (or other licensed premises where the harvested material
is located), a department employee shall load, or observe the loading, of the
harvested material until the material is completely secured on or in the
vehicle.
(b) During the transport:
A department employee shall accompany the harvested material as it moves in a
vehicle directly to a department-approved location. The vehicle shall
constantly move towards its final destination without unnecessary stops, stops
for reasons unrelated to the transport task, or stops of an extended
duration.
(c) After the transport:
Upon arrival at the department-approved location, a department employee shall
unload, or observe the unloading, of the harvested material until the material
is completely removed from the vehicle.
(d) Following the material's removal from the
vehicle, a department employee shall personally observe the harvested
material's destruction (the act of rendering it into a useless and
non-retrievable state) using one (1) of these methods:
1. By grinding it up and incorporating it
into the soil; or
2. By controlled
incineration.
Section 9. Incorporation by Reference.
(1) The following material is incorporated by
reference:
(a) "UK DRS SOP# HM-MT-001
(Procedures for Measuring THC Content in Hemp by Gas Chromotography with Flame
Ionization Detection (GC/FID)", 2021;
(b) "UK DRS SOP# HM-LB-001 (Procedures for
Receiving, Preparing and Releasing Hemp)", 2021;
(c) "MSU BVC SOP # TOX WIN 0042 (Hemp
Receiving)", 2020;
(d) "MSU BVC SOP
# TOX WIN 0043 (Hemp Storage and Destruction)", 2020;
(e) "MSU BVC SOP # TOX WIN 0069 (Hemp
Potency)", 2020; and
(f)
"Inspection and Sample Collection Form", 1/2022.
(2) These materials may be inspected, copied,
or obtained, subject to applicable copyright law, at the Kentucky Department of
Agriculture, Office of Agricultural Marketing, 105 Corporate Drive, Frankfort,
Kentucky 40601, Monday through Friday, 8:00 a.m. to 4:30 p.m. These materials
may also be obtained at
www.kyagr.com.
47 Ky.R. 659,
1210; eff. 3-2-2021;
48
Ky.R. 1647, 2478; eff. 7/5/2022.
STATUTORY AUTHORITY:
KRS
260.862,
7 U.S.C.
1639p