This website publishes administrative rules on their effective dates, as designated by the adopting state agencies, colleges, and
universities.
| Rule |
Rule 901:14-2-01 | Definitions.
Effective:
January 31, 2020
(A) "Abandoned application"
means an application for licensure which was returned to the applicant by the
department as incomplete and not finalized or corrected by the applicant and
returned to the department within thirty days. (B) "Acceptable hemp THC level"
means the application of the measurement of uncertainty to the reported delta-9
tetrahydrocannabinol content concentration level on a dry weight basis that
produces a distribution or range that includes 0.3 per cent or
less. (C) "Adulterated" has the same meaning as found
in section 3715.59 of the Revised Code. (D) "Batch or lot" means the hemp products
produced during a period indicated by a specific code. (E) "Controlled substance" has the same meaning
as found in section 3719.01 of the Revised Code. (F) "Cosmetic" has the same meaning as found in
division (A)(5) of section 3715.01 of the Revised Code. (G) "Delta-9 tetrahydrocannabinol" of
"THC" means the sum of the percentage by weight of
tetrahydrocannabinolic acid multiplied by 0.877 plus the percentage by weight
of delta-9 tetrahydrocannabinol. (H) "Department" means the Ohio department of
agriculture. (I) "Dietary supplement" has the same meaning as
found in section 3715.80 of the Revised Code. (J) "Director" means the director of Ohio
department of agriculture or the director's designee. (K) "Disqualifying offense"
means any felony involving a controlled substance including, but not limited
to, violations of the Revised Code, specifically: (1) Division (A)(1)(a) of
section 2907.02. (2) Division (A)(2) of
section 2907.05. (3) Division (D)(2) of
section 2923.16. (4) Section
2923.241. (5) Chapters 2925, 3719,
and 3796. (L) "Drug" has the same meaning as found in
division (A)(3) of section 3715.01 of the Revised Code. (M) "Food" has the same meaning as found in
division (A)(2) of section 3715.01 of the Revised Code. (N) "Hemp" means the plant Cannabis sativa L. and
any part of that plant, including the seeds thereof and all derivatives,
extracts, cannabinoids, isomers, acids, salts, and salts of isomers, whether
growing or not, with a delta-9 tetrahydrocannabinol concentration of not more
than three-tenths per cent on a dry weight basis. (O) "Hemp product" means any product, containing
a delta-9 tetrahydrocannabinol concentration of not more than three-tenths per
cent, that is made with hemp. "Hemp product" includes hemp buds,
flowers, cigarettes, cigars, shredded hemp, cosmetics, personal care products,
dietary supplements or food intended for animal or human consumption, cloth,
cordage, fiber, fuel, paint, paper, particleboard, and any other product
containing one or more cannabinoids derived from hemp, including
cannabidiol. (P) "Immediate family" means a licensee's
spouse, parents, children, grandparents, siblings, grandchildren,
brother-in-law, sister-in-law, daughter-in-law, son-in-law, mother-in-law,
father-in-law, step-parents, step-children, step-siblings, or a legal guardian
or other person who stands in the place of a parent (in loco
parentis). (Q) "Key participant" means a
sole proprietor, a partner in partnership, or a person with executive
managerial control in a corporation. A person with executive managerial control
includes persons such as a chief executive officer, chief operating officer and
chief financial officer. This definition does not include non-executive
managers such as farm, field, or shift managers. (R) "Measurement of
uncertainty" or "MU" 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
measurement. (S) "Misbranded" has the same meaning as found in
section 3715.60 of the Revised Code. (T) "Process" or "processing" means
converting hemp into a hemp product. Except that process or processing does not
include on-farm drying, dehydrating, or packaging of raw hemp materials by a
licensed hemp cultivator for sale directly to a licensed hemp
processor. (U) "Public park" means a park established by the
federal government, state, or a political subdivision of the state including a
county, township, municipal corporation, or park district. (V) "Retail hemp production" means the production
of hemp products that are prepared, served or otherwise held or handled for
sale to the end consumer at the site of production. Retail hemp production
includes a mobile retail facility. (W) "School" means a child day-care center as
defined under section 5104.01 of the Revised Code, a preschool as defined under
section 2950.034 of the Revised Code, or a public or nonpublic primary school
or secondary school. (X) "University" means an institution of higher
education as defined in section 3345.12 of the Revised Code and a private
nonprofit institution with a certificate of authorization issued pursuant to
Chapter 1713. of the Revised Code. (Y) "USDA" means the United States department of
agriculture. (Z) "Wholesale hemp production" means the
production of hemp products that are processed, packaged, manufactured, or
otherwise held or handled for distribution to another location or for sale at
wholesale.
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Rule 901:14-2-02 | Processing License.
Effective:
January 31, 2020
(A) No person shall process hemp without
a hemp processing license issued by the department. (B) Hemp processing licenses are valid
for a period of three years provided that the licensee is compliant with
Chapter 928. of the Revised Code and this chapter. (C) Hemp processing licenses shall be
renewed every three years by complying with the rules of this paragraph,
including obtaining the required background check(s) as outlined in rule
901:14-2-05 of the Administrative Code. (D) The department may only issue a hemp processing license
if the applicant has: (1) Submitted a complete
application as outlined in rule 901:14-2-03 of the Administrative
Code; (2) Submitted both the application fee,
if during the first year of licensure, and the annual license fee as outlined
in rule 901:14-2-04 of the Administrative Code; (3) Completed the
required background check(s) as outlined in rule 901:14-2-05 of the
Administrative Code and the applicant and no key participant of the business
entity has, within the last ten years, plead guilty to or been convicted of a
disqualify offense. (4) Successfully passed
the initial facility inspection performed by the department to determine that
the facility is in compliance with Chapter 928. of the Revised Code and this
chapter. (E) Prior to years two and three of the
license period, licensees shall remit the annual license fee to the
department. (F) Any licensee or key participant in the business entity
who, during the time of licensure, pleads guilty to or is convicted of a
disqualifying offense shall have their license revoked or suspended by the
department if the licensee or key participant is not removed from the entity
within thirty days from the date of plea or conviction. (G) A processing license is valid only for the individual
or business entity, and the key participants in the business entity, for which
it is issued. A processing license may only be transferred or assigned
if: (1) The licensee notifies
the department in writing of the proposed transfer or key participant
change; (2) The licensee ensures
that the background checks as outlined in rule 901:14-2-05 of the
Administrative Code have been completed; and (3) The licensee can
demonstrate that the licensee will remain in compliance with this
chapter. (H) A processing license is valid only
for the facility which was inspected at the time of original
licensure. (I) The following are not required to obtain a processing
license under this chapter: (1) A university who has
been specifically authorized by the director to process hemp for research
purposes. (2) Any person who is a
subordinate employee or immediate family member of the licensed processor so
long as these individuals are acting under the instructions and control of the
licensed processor within the licensed facility. Any actions taken by these
individuals shall be the responsibility of the licensed processor.
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Rule 901:14-2-03 | Processing application.
Effective:
January 31, 2020
(A) A person applying for a hemp
processing license shall apply on a form provided by the
department. (B) An applicant shall provide all of the
following information to the department: (1) If the applicant is
an individual: (a) The full legal name of the applicant; (b) The physical address of the applicant; (c) The mailing address of the applicant; (d) The email address of the applicant; and (e) The phone number of the applicant. (2) If the applicant is a
business entity: (a) The full name of the business; (b) The federal tax
identification number of the business; (c) The mailing address of the business; (d) The principal business location in the state of
Ohio; (e) The full name of the individual who is authorized to
sign on behalf of the business entity; (f) The full name, title, and email address of the
individual(s) who will be primarily responsible for the hemp operations of the
business entity; (g) The identity of every
key participant in the business entity applying for licensure; (h) The information required in paragraph (B)(1) of this
rule for each party identified in paragraph (B)(2)(g) of this
rule; (i) Phone number for the business entity; and (j) Email address for the business entity. (3) For each processing
location: (a) The global position system coordinates; (b) The physical address; and (c) Maps for each building or storage facility where hemp
will be processed or stored. (4) List of the types of
hemp products that will be produced. (5) Any other information
required by the department. (C) If applicable, the applicant shall
provide the following: (1) The extraction
operational plan as outlined in rule 901:14-2-11 of the Administrative
Code. (2) Documentation that
the applicant is currently in compliance, with all building, fire, safety, and
zoning statutes, local ordinances, and rules and regulations adopted by the
locality in which the applicant's property is located, which are in effect
at the time of the application, including but not limited to building
department approval demonstrating compliance with rules adopted by the board of
building standards pursuant to Chapters 3781. and 3791. of the Revised Code and
any applicable zoning considerations. (D) Any incomplete application will be
returned to the applicant by the department. (E) Abandoned applications shall not be
reviewed by the department and destroyed. (F) Failure to remit required fees in a
timely or complete manner may result in the department taking enforcement
action as defined in rule 901:14-2-99 of the Administrative Code.
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Rule 901:14-2-04 | Fees.
Effective:
January 31, 2020
(A) Processing fee schedule. (1) The application fee shall be one
hundred dollars for each processing application. (2) The annual license fee shall be five
hundred dollars for processing the raw grain component of hemp for each
processing site. (3) The annual license fee shall be five
hundred dollars for processing the raw fiber component of hemp for each
processing site. (4) The annual license fee shall be three
thousand dollars for processing the raw floral component of hemp for each
processing site. (5) The annual license fee for processors
using cannabinoids in human and animal food, dietary supplements, cosmetics,
and personal care product for each processing site shall be: (a) Five hundred dollars for wholesale production;
and (b) Two hundred fifty dollars for retail
production. (6) A processor of more than one
component shall pay the annual license fee of each component. (7) All samples taken
pursuant to the chapter shall be taken free of charge for testing conducted by
the department. The samples become the property of the department and are
non-returnable. (B) The fees established in this rule
shall be nonrefundable.
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Rule 901:14-2-05 | Background checks.
Effective:
February 17, 2020
(A) All applicants and key participants
in the business entity, if applicable, shall submit to a criminal records check
completed by the bureau of criminal identification and investigation in
accordance with section 928.03 of the Revised Code. (B) Applicants submitting a renewal
application must comply with paragraph (A) of this rule prior to the expiration
of their existing license. (C) The department shall not grant a license to an
applicant unless the applicant and all key participants complete a criminal
background check and have not plead guilty or been convicted of a disqualifying
offense in the ten years prior to applying for a license. No background check
that was completed in excess of sixty-days prior to application can be accepted
by the department. (D) The applicant requesting a criminal records check shall
submit with a request to the bureau of criminal identification and
investigation: a completed copy of a form prescribed under division (C)(1) of
section 109.572 of the Revised Code; a set of fingerprint impressions obtained
as described in division (C)(2) of section 109.572 of the Revised Code; the
applicant's name and address; the department's name and address; and,
a request that the superintendent of the bureau of criminal identification and
investigation obtain from the federal bureau of investigation any information
it has pertaining to the applicant. (E) The department shall only accept results of a criminal
records check submitted to the department directly from the bureau of criminal
identification and investigation. (F) The applicant shall bear all costs associated with the
criminal records check as determined by the bureau of criminal identification
and investigation, the federal bureau of investigation, and by any agency with
authority to charge a fee for fingerprint impressions. (G) If the department does not receive the background check
of all required parties within thirty days of submitting their application, the
application shall be deemed an abandoned application unless the applicant
requests an extension waiver of thirty days to complete the background check
requirement. If the department does not receive the background check by the end
of the extension period, the department will consider the application
abandoned.
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Rule 901:14-2-06 | Land use restrictions for licensed processors.
Effective:
January 31, 2020
A licensed processor shall not: (A) Process or store any cannabis that is
not hemp. (B) Process or store hemp or hemp
products on any site not approved by the department. (C) Process, handle, or store hemp or
hemp products in a building used as a personal residence or on land that is
zoned for residential use. (D) Process, handle or store hemp or hemp
products in or adjacent to any structure that is used or zoned for residential
purposes. (E) Process hemp in any location, unless
prior approval is received in writing from the department, that is located
within five hundred feet of the boundaries of a parcel of real estate, measured
from the closest point of the property lines, having situated on it a school or
public park. Except that this does not apply to research being conducted by a
university that is approved by the director.
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Rule 901:14-2-07 | Financial responsibility.
Effective:
February 17, 2020
(A) Any licensed processor who purchases
raw, unprocessed hemp plant material shall meet the standards of financial
responsibility required under this rule. (B) Each licensed processor having sold
equal to or less than one hundred thousand dollars of raw, unprocessed hemp
plant material in the previous calendar year shall have and maintain a surety
bond in the amount of ten thousand dollars. Each licensed processor having sold
more than one hundred thousand dollars of raw, unprocessed hemp plant material
in the previous calendar year shall have and maintain a surety bond in the
amount of twenty thousand dollars. (C) In order to demonstrate the financial
responsibility required in paragraph (B) of this rule, the licensed processor
shall file a surety bond issued by a corporate surety company that is
authorized to do business under the laws of this state with the department. The
surety bond shall be subject to redemption by the state only upon a suspension,
revocation, or insolvency of a licensed processor for the purpose of repaying
the licensed processor's obligations to creditors which are licensed
cultivators pursuant to Chapter 901:14-1 of the Administrative Code. Redemption
shall only be for an amount equal to the claims made by creditors which are
licensed cultivators. Regardless of the amount of claims made against the bond
and the number of periods the bond covers, the maximum liability under the bond
is the penal sum. The bond shall be continuous. The bond shall, however,
include a provision for cancellation, subject to a notice period of thirty days
with notice provided to the processor and to the department.
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Rule 901:14-2-08 | Inspection and sampling.
Effective:
January 31, 2020
(A) All hemp processing facilities shall
be subject to inspection and sampling by the department for compliance with
Chapter 928. of the Revised Code and this chapter. (B) Representatives of the department
shall be provided with complete and unrestricted access to all hemp and other
cannabis plants, and all land, buildings, and other structures used for the
processing, handling, and storage of all hemp and other cannabis plants; and
all locations listed in the license application. (C) Samples may be collected by the
department and tested to determine compliance with Chapter 928. of the Revised
Code and this chapter. (D) All samples taken pursuant to the
rule shall be provided for testing conducted by the department at no cost to
the department. The samples become the property of the department and are
non-returnable.
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Rule 901:14-2-09 | Food safety regulations.
Effective:
January 31, 2020
All hemp processors shall comply with all
applicable federal food safety regulations adopted in Chapter 901:3-17 of the
Administrative Code.
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Rule 901:14-2-10 | Sources.
Effective:
January 31, 2020
(A) All hemp processors extracting
cannabinoids from hemp plant material shall obtain these materials
from: (1) A licensed hemp
cultivator in the state of Ohio; (2) A licensed cultivator
in another state or jurisdiction's hemp program which has been approved by
the United States department of agriculture under 7 U.S.C. 1639; or
(3) An entity residing in
a foreign jurisdiction where the hemp material has been tested in accordance
with rule 901:14-1-10 of the Administrative Code. (B) All hemp processors using extracted
cannabinoids in their hemp products shall obtain the extracted material
from: (1) A licensed hemp
processor in the state of Ohio; or (2) An entity residing in
a jurisdiction where the extracted cannabinoids have been extracted and tested
in accordance with rule 901:14-2-12 to rule 901:14-2-15 of the Administrative
Code. (C) During the extraction process, all
extracted cannabinoids must be brought down to a delta-9-tetrahydrocannabinol
within the acceptable hemp THC level before final formulation or manufacturing
of the final product. At no point shall an extracted oil which exceeds the
acceptable hemp THC level be added to another hemp product. (D) Hemp processors shall maintain
records indicating compliance with paragraphs (A), (B), and (C) of this rule in
accordance with rule 901:14-2-18 of the Administrative Code.
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Rule 901:14-2-11 | Extraction operational plan.
Effective:
January 31, 2020
All processors extracting cannabinoids from hemp
plant material shall have and follow an operational plan. The plan shall
include at a minimum: (A) Implementation of standards and guidelines for
processing of plant material and the extraction of cannabinoids; (B) Establish training and safety policies for the safe
operation and maintenance of any and all equipment that will be used for
extracting cannabinoids to ensure that any person involved in processing
hemp: (1) Has been fully trained in the safe
operation and maintenance of any and all equipment that will be used for hemp
extraction, with supporting documentation of the training; (2) Has been fully trained in the safe
use, handling, and storage of any and all chemicals that will be used for hemp
extraction, in accordance with OSHA protocols, with supporting documentation of
the training; (3) Has been fully trained in the safe
and sanitary execution of any applicable post-extraction refining protocols;
and (4) Has been fully trained in the safe
and sanitary execution of any applicable manufacturing processes, including any
applicable food safety standards under Chapter 901:3-117 of the Administrative
Code. (C) Documents the processing and extraction methods,
techniques, and standards used which complies with rule 901:14-2-12 of the
Administrative Code.
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Rule 901:14-2-12 | Extraction methods and training.
Effective:
January 31, 2020
A processor may only use the methods, solvents, and
gases set forth in this rule in the manufacture of hemp products. (A) A processor may use hydrocarbon solvent-based
extraction methods in a spark-free and properly ventilated environment,
isolated from any open flame or ignition source, and may use the following
solvents, at a minimum of ninety-nine per cent purity, in a professional grade,
closed-loop extraction system designed to recover the solvents: (1) Propane; (2) N-butane; (3) Isobutane; (4) Heptane; or (5) Other solvents exhibiting minimal
potential toxicity to humans with the approval of the department. (B) A processor may use carbon dioxide-based extraction
methods using food grade carbon dioxide at a minimum of ninety-nine per cent
purity in a professional grade, closed-loop system in which each vessel is
rated to a minimum pressure to accommodate the specific extraction protocol,
including supercritical, liquid, and subcritical. (C) A processor may use ethanol at a minimum of ninety-nine
per cent purity to produce extracts for use in the manufacture of hemp
products. (D) A processor may use food grade glycerin and propylene
glycol in the manufacture of hemp products. (E) A processor may use non-solvent extraction methods
involving the mechanical separation of cannabinoids from plant material to
produce hemp extracts for use in the manufacture of hemp products. (F) A processor shall comply with all applicable OSHA
regulations as well as comply with and pass inspection for any applicable fire,
safety, and building codes pertaining to the use and storage of the equipment
and solvents used in the manufacture of hemp products. (G) A processor using hydrocarbon solvent-based or carbon
dioxide extraction methods shall designate at least one individual to train and
supervise employees in the use of extraction equipment and associated solvents
who has earned, at minimum, a bachelor's degree in engineering or physical
sciences from an accredited university, or who has at least three years of
experience in the operation of the equipment being used in the facility or
similar equipment.
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Rule 901:14-2-13 | Laboratory testing.
Effective:
January 31, 2020
(A) All hemp products prior to being
offered for sale shall be tested in accordance with this rule. (B) The hemp processor shall select a
random sample from every batch or lot of hemp products produced at their
facility that is of sufficient quantity to perform the required tests. The
sample shall be tested by a testing laboratory which meets the requirements of
rule 901:14-2-14 of the Administrative Code. (C) Unless otherwise stated in paragraph (G) of this rule,
a processor shall have the testing laboratory test every required hemp product
sample for: (1) Microbial
contaminants of public health concern; (2) Cannabinoid potency
including, at minimum: (a) Delta-9-tetrahydrocannabinolic acid
(THCA); (b) Delta-9-tetrahydrocannabinol (THC); (c) Cannabidiolic acid (CBDA); (d) Cannabidiol (CBD); and (e) All other cannabinoids listed on the product
label. (3) Mycotoxins; (4) Heavy metals,
including, at a minimum, arsenic, cadmium, lead, and mercury; and (5) Residual solvents, if a solvent other
than carbon dioxide was used in the extraction process, if
applicable. (D) The processor shall have the testing
laboratory estimate and report the measurement of uncertainty with the test
results for the cannabinoids listed in paragraph (C)(2) of this
rule. (E) The processor shall obtain from the testing laboratory
a certificate of analysis that meets the requirements of rule 901:14-2-15 of
the Administrative Code of every hemp product sample tested. (F) A processor shall not sell or otherwise distribute the
hemp product unless the product meets the standards set forth in Chapter 928.
of the Revised Code and this chapter. (G) Exceptions: (1) Hemp products which are used
exclusively for fiber purposes are exempt from compliance from rules
901:14-2-13 to 901:14-2-15 of the Administrative Code. (2) Hemp products derived
exclusively from hemp seed are exempt from compliance from rules 901:14-2-13 to
901:14-2-15 of the Administrative Code. (3) Hemp products that contain a hemp
extract or cannabinoids are exempt from the testing requirements found in
paragraphs (C)(1) and (C)(3) to (C)(5) of this rule so long as: (a) The hemp extract and/or cannabinoids were acquired from
a source identified in rule 901:14-2-10 of the Administrative Code;
and (b) The hemp extract and/or cannabinoids were accompanied
with a certificate of analysis that meets the requirements of rule 901:14-2-15
of the Administrative Code; and (i) The certificate of
analysis matches the batch or lot used in the production of the hemp products
by the processor; and (ii) The certificate of analysis was produced by a
laboratory which meets the requirements of rule 901:14-2-14 of the
Administrative Code.
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Rule 901:14-2-14 | Testing laboratories.
Effective:
January 31, 2020
For the purposes of this chapter, "testing
laboratory" means any laboratory which is accredited to the 2017 edition
of ISO/IEC 17025 "General Requirements for the Competence of Testing and
Calibration Laboratories" standard by a non-profit accreditation body that
is signatory to the "International Laboratory Accreditation Cooperation
(ILAC) Mutual Recognition Agreement (MRA)" and which operates in
accordance with ISO/IEC 17011 "General Requirements for accreditation
Bodies Accrediting Conformity Assessment Bodies." The methods utilized by the laboratory in testing
done pursuant to this chapter must be within their scope of
accreditation.
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Rule 901:14-2-15 | Laboratory reporting.
Effective:
January 31, 2020
(A) A licensed processor shall ensure
that the testing laboratory selected create a unique certificate of analysis
for each batch or lot tested on its behalf, which shall include, at
minimum: (1) The name and address
of the testing laboratory where the analysis was performed; (2) The ISO certification
number of the testing laboratory; (3) The name of the processor from whom
the sample was received; (4) The address of the
processing facility where the sample was processed; (5) The name of the product
tested; (6) A unique batch or lot number that
will match the hemp product, in order to facilitate any warnings or recalls the
department deems appropriate; (7) The date or dates on which each test
was performed; (8) The date or dates the
sample was collected; (9) The cannabinoid profile of the
sample, including the percentage content by weight for, at
minimum: (a) Delta-9-tetrahydrocannabinol (THC); (b) Delta-9-tetrahydrocannabinolic acid
(THCA); (c) Cannabidiol (CBD); (d) Cannabidiolic acid (CBDA); and (e) All other cannabinoids listed on the product
label. (10) Results of analysis
for microbial contamination, as applicable; (11) Quantitative results
of analysis for heavy metal contamination, as applicable; (12) Quantitative results of analysis for
mycotoxins, as applicable; (13) Quantitative results of analysis for
residual solvents, as applicable; and (14) The signature of the laboratory
manager or scientific director certifying the analysis. (B) The certificate of analysis may
contain the following: (1) Results of
quantitative analysis of additional cannabinoids for which the laboratory is
able to obtain a standard for comparison; and (2) Results of
quantitative analysis of terpenes for which the laboratory is able to obtain a
standard for comparison.
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Rule 901:14-2-16 | Processor waste disposal.
Effective:
January 31, 2020
(A) For the purpose of this rule,
"hemp byproducts and waste" means a byproduct, produced as a result
of processing hemp, that contains more than 0.3 per cent THC by dry weight
basis. (B) A licensed processor shall dispose of hemp byproducts
or waste in such a manner as to render the hemp byproduct or waste
unusable. (C) Hemp byproducts or waste that is rendered unusable
shall be discarded into a locked dumpster or other approved, locked container
for removal from the facility by a waste removal company selected by the
processor. Hemp byproducts or waste shall be rendered unusable by the processor
by grinding and incorporating the hemp byproducts or waste with one or more of
the non-consumable, solid wastes listed below, such that the resulting mixture
is at least fifty-one per cent non-hemp byproduct or waste: (1) Paper
waste; (2) Cardboard
waste; (3) Food
waste; (4) Yard
waste; (5) Soil or other growth
media; (6) Other wastes approved
by the department. (D) The processor shall maintain and make
available in accordance with this chapter a separate record of every disposal
indicating: (1) The date and time of
disposal; (2) The manner of
disposal; (3) The volume and weight
of approved solid waste used to render the hemp byproducts or waste
unusable; (4) The reasoning for and
description of the disposal; (5) The batch number or numbers, volume,
and weight of any hemp extract or plant material being disposed of;
and (6) The lot number, product name, volume,
weight, and unit count of any hemp product being disposed of.
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Rule 901:14-2-17 | Labeling.
Effective:
January 31, 2020
(A) All hemp products, except for those
made exclusively from hemp fibers, shall be labeled: (1) In accordance with
the following standards: (a) The labeling requirements found in rule 901:3-1-11 of
the Administrative Code. (b) The standard of identity requirements found in rule
901:3-1-12 of the Administrative Code. (c) The food coloring requirements found in rule 901:3-1-13
of the Administrative Code. (2) With the milligrams
per serving for all cannabinoids as identified on the product label, if the
hemp product meets the definitions of either a food or dietary supplement as
found in rule 901:14-2-01 of the Administrative Code. (3) With the total
milligrams per unit for all cannabinoids as identified on the product label, if
the hemp product meets the definitions of a cosmetic product as found in rule
901:14-2-01 of the Administrative Code. (4) With the cannabinoid
profile of the product that matches the laboratory reporting for each unique
batch or lot as required in paragraph (A)(9) of rule 901:14-2-15 of the
Administrative Code, if the hemp product does not meet the definitions of food,
dietary supplement, or cosmetic products as found in rule 901:14-2-01 of the
Administrative Code. (5) With the unique batch or lot coding
that will match the hemp product with a batch or lot, in order to facilitate
any warnings or recalls the department deems appropriate. (a) Each container or product shall be marked with an
identifying code permanently visible to the naked eye. (b) The required identification shall specify in code the
establishment where the product was packed, the product contained therein, and
the year, day, and period during which it was packed. (c) The packing period code shall be changed often enough
to enable ready identification of lots during their sale and distribution.
(d) Codes may be changed periodically on one of the
following bases: (i) Intervals of four to
five hours; (ii) Personnel shift
changes; or (iii) Batches, as long as
the containers constituting the batch do not represent those processed during
more than one personnel shift. (6) With a statement, if the products
contain cannabinoids, indicating that consumers should consult a licensed
healthcare professional if pregnant, breast feeding, currently taking
medications, or under eighteen years of age. This statement shall appear prominently and
conspicuously as compared to other words, statements, or designs on the
information panel of the immediate container label, but in no case may the
letters be less than one-sixteenth inch in height. Where the immediate
container is not the retail package, this warning statement shall also appear
prominently and conspicuously on the information panel of the retail package
label. This requirement does not apply to products
derived exclusively from hemp seed oil. (B) Hemp product labeling requirements by
classification: (1) All hemp products
which meet the definition of a food as found in rule 901:14-2-01 of the
Administrative Code shall meet the labeling requirements in 21 C.F.R. 101.9
(2018). (2) All hemp products
which meet the definition of a dietary supplement as found in rule 901:14-2-01
of the Administrative Code shall meet the labeling requirements in 21 C.F.R.
101.36 (2018). (3) All cosmetic products
shall be labeled in accordance with 21 C.F.R. Part 701 (1974) and 21 C.F.R. 714
(2019) as applicable.
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Rule 901:14-2-18 | Records.
Effective:
January 31, 2020
(A) Each processor shall keep and
maintain upon the licensed premises for a five-year period, unless otherwise
stated in these rules, true, complete, legible, and current books and records.
All required records must be made available for inspection if requested by the
department. The following records shall be maintained: (1) Records relating the
purchase of raw, unprocessed plant material including: (a) Name and license number of licensed cultivator from
which the processor purchased the material; (b) If the licensed cultivator is licensed in a state or
jurisdiction other than Ohio, the state or jurisdiction of licensure, their
address, and a copy of their cultivator license; (c) A bill of sale or other document that indicates the
purchase price, purchased quantity, and date of sale; (d) The certificate of analysis from the appropriate
laboratory authority which indicates that the purchased material meets the
definition of hemp; and (e) A document indicating the total purchase amount of raw,
unprocessed plant material in the last calendar year. (2) Records relating to
the purchase or use of extracted cannabinoids: (a) Name and license number of licensed processor from
which the processor purchased the material; (b) If the licensed hemp processor is from a state or
jurisdiction other than Ohio, the originating state or jurisdiction, the
processor's address, and a copy of their last inspection report;
(c) A bill of sale or other document that indicates the
purchase price, purchased quantity, and date of purchase. (d) The certificate of analysis from the testing laboratory
which meets the requirements of rule 901:14-2-14 of the Administrative Code
which indicates that the material meets the definition of hemp and hemp product
as outlined in rule 901:14-2-15 of the Administrative Code. (3) Records relating to
the extraction process: (a) The operational plan as required by rule 901:14-2-11 of
the Administrative Code; (b) Records showing that the extraction method utilized
meets the requirements of rule 901:14-2-12 of the Administrative Code;
and (c) All applicable fire, safety, and building code
documents and inspection reports. (4) Certificate of
analysis as required by rule 901:14-2-13 of the Administrative
Code. (5) Records relating to
disposal as required by rule 901:14-2-16 of the Administrative
Code. (B) A processor may use an electronic
system for the storage and retrieval of records required by this rule and
chapter. Any loss of electronically-maintained records shall not be considered
a mitigating factor for violations of this rule.
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Rule 901:14-2-19 | Prohibited products.
Effective:
January 31, 2020
(A) The following products shall not be
offered for sale: (1) Any hemp product which exceeds the
acceptable hemp THC level. (2) All hemp products
contained in a batch or lot which via laboratory testing: (a) Fails to satisfy the standards set forth in Table 9 of
the "Cannabis Inflorescence: Standards of Identity, Analysis, and Quality
Control" (2014) monograph. (b) For the purposes of mycotoxin contamination
analysis: (i) The total of the
detected amounts, if any, of aflatoxin B1, aflatoxin B2, aflatoxin G1, and
aflatoxin G2 exceeds twenty micrograms per kilogram; and (ii) The detected amount,
if any, of ochratoxin A exceeds twenty micrograms per kilogram. (c) For the purposes of heavy metal contamination
analysis: (i) The detected amount
of arsenic, if any, exceeds 0.42 parts per million. (ii) The detected amount
of cadmium, if any, exceeds 0.27 parts per million. (iii) The detected amount
of lead, if any, exceeds 0.87 parts per million. (iv) The detected amount
of mercury, if any, exceeds 0.87 parts per million. (d) For the purposes of pesticide residue analysis, fails
to satisfy the most stringent acceptable standard for an approved pesticide
chemical residue in a food item as set forth in 40 C.F.R. Part 180, as
effective on September 8, 2017. (3) Any hemp product that
was produced in violation of Chapter 928. of the Revised Code or this
chapter. (B) Any prohibited product, as well as
all products in their corresponding batch or lot, as outlined in paragraph (A)
of this rule shall be immediately destroyed by the processor.
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Rule 901:14-2-20 | Notice of adulteration or misbranding.
Effective:
February 17, 2020
(A) Whenever the director of agriculture
finds or has cause to believe, that any hemp product is adulterated or so
misbranded as to be dangerous or fraudulent, within the meaning of sections
3715.01 and 3715.52 to 3715.72 of the Revised Code, the director shall affix to
the hemp product a tag or other appropriate marking, giving notice that the
hemp product is, or is suspected of being, adulterated or misbranded, and has
been detained or embargoed, and warning all persons not to remove or dispose of
the hemp product by sale or otherwise until permission for removal or disposal
is given by the director. (B) When a hemp product detained or
embargoed has been found by the director to be adulterated or misbranded, the
director shall petition the municipal or county court in whose jurisdiction the
hemp product is detained or embargoed for an order for condemnation of the hemp
product. (C) If the court finds that a hemp
product is adulterated or misbranded, the hemp product shall, after entry of
the decree, be destroyed at the expense of the claimant thereof, under the
supervision of the director, and all court costs, fees, storage, and other
proper expenses shall be taxed against the claimant of the hemp product or the
claimant's agent; provided, that when the adulteration or misbranding can
be corrected by proper labeling or processing of the hemp product, the court,
after entry of the decree and after such costs, fees, and expenses have been
paid and a good and sufficient bond as ordered by the court, conditioned that
the hemp product shall be so labeled or processed, has been executed, may by
order direct that the hemp product be delivered to the claimant thereof for
labeling or processing under the supervision of the director. The expense of
supervision shall be paid by the claimant. The bond shall be returned to the
claimant of the hemp product on representation to the court by the director
that the hemp product is no longer in violation of sections 3715.01 and 3715.52
to 3715.72 of the Revised Code, and that the expenses of supervision have been
paid.
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Rule 901:14-2-21 | Cooperation with law enforcement and other federal agencies.
Effective:
January 31, 2020
(A) The department shall provide
information about approved processing, handling, and storage site locations to
representatives of the United States department of agriculture (USDA), and any
federal, state, or local law enforcement agency whose representatives request
licensed site information, including GPS coordinates. (B) Immediately upon request, licensees
shall produce a copy of his or her license to a representative of the
department or a law enforcement agency.
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Rule 901:14-2-99 | Enforcement.
Effective:
January 31, 2020
(A) The director shall deny, suspend, or
revoke a hemp processing license if the licensed processor or applicant
has: (1) Provided false or
misleading information on the hemp processing application or renewal
application; (2) Not complied with the
background check requirements as outlined in rule 901:14-2-05 of the
Administrative Code; (3) Plead guilty to or
was convicted of a felony relating to a controlled substance within the last
ten years; and (4) Negligently violated
section 928.04 of the Revised Code or this chapter three or more times in any
five-year period. (B) If the director determines that a
licensed processor has negligently violated a provision in Chapter 928. of the
Revised Code or this chapter, the director shall issue a corrective action plan
to the licensed processor. The director shall include in the corrective action
plan both of the following: (1) A reasonable date by
which the licensed processor shall correct the violation; and (2) A requirement that
the licensed processor shall report to the director regarding the licensed
processor's compliance with the requirements of this chapter, rules
adopted under it, and the corrective action plan for two calendar years
immediately following the date of the violation. (C) The director may suspend or revoke a
hemp processing license if the licensee has failed to comply with Chapter 928.
of the Revised Code or this chapter. (D) If the director has or proposed to have denied,
suspended, or revoked a hemp processing license, the licensed processor or
applicant shall be afforded a hearing in accordance with Chapter 119. of the
Revised Code.
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