The following words and terms, when used in this chapter, have
the following meanings unless context clearly indicates otherwise:
(1)Acceptable hemp THC level--A delta-9 tetrahydrocannabinol
content concentration level on a dry weight basis, that, when reported
with the accredited laboratory's measurement of uncertainty, produces
a distribution or range that includes a result of 0.3 percent or less.
(2)Accredited laboratory--A laboratory, including
at an institution of higher education, accredited in accordance with
the International Organization for Standardization ISO/IEC 17025 or
a comparable or successor standard.
(3)Act--House Bill 1325, 86th Legislature, Regular
Session, 2019, relating to the production and regulation of hemp in
Texas, codified in Texas Health and Safety Code, Chapter 443.
(4)Analyte--A chemical, compound, element, bacteria,
yeast, fungus, mold, or toxin identified and measured by accredited
(5)Approved hemp source--Hemp and hemp products grown
for human use and consumption produced under a state or a compatible
federal, foreign, or Tribal plan, approved by the United States Department
of Agriculture under 7 United States Code (U.S.C.) Chapter 38, Subchapter
VII, or Texas Agriculture Code, Chapter 121, or in a manner that is
consistent with federal law and the laws of respective foreign jurisdictions.
(6)Cannabidiol (CBD)--A phytocannabinoid identified
as an extract from cannabis plants.
(7)Certificate of Analysis (COA)--An official document
released by the accredited laboratory to the manufacturer, processor,
distributor, or retailer of consumable hemp products, the public,
or department, which contains the concentrations of cannabinoid analytes
and other measures approved by the department, to also include data
on levels of THC and state whether a sample passed or failed any limits
of content analysis.
(8)Consumable hemp product (CHP)--Any product processed
or manufactured for consumption that contains hemp, including food,
a drug, a device, and a cosmetic, as those terms are defined by Texas
Health and Safety Code, §431.002, but does not include any consumable
hemp product containing a hemp seed, or hemp seed-derived ingredient
being used in a manner that has been generally recognized as safe
(GRAS) by the FDA.
(9)Consumable hemp products license--A license issued
to a person or facility engaged in the act of manufacturing, extracting,
processing, or distributing consumable hemp products for human consumption
(10)Delta-9 tetrahydrocannabinol (THC)--The primary
psychoactive component of cannabis. For the purposes of this chapter,
the terms delta-9 tetrahydrocannabinol and THC are interchangeable.
(11)Department--Department of State Health Services.
(12)Distributor--A person who distributes consumable
hemp products for resale, either through a retail outlet owned by
that person or through sales to another retailer. A distributor is
required to hold a consumable hemp products license.
(13)Facility--A place of business engaged in manufacturing,
processing, or distributing consumable hemp products subject to the
requirements of this chapter and Texas Health and Safety Code, Chapter
431. A facility includes a domestic or foreign facility that is required
to register under the Federal Food, Drug, and Cosmetic Act, Section
415 in accordance with the requirements of 21 Code of Federal Regulations
Part 1, Subpart H.
(14)FDA--The United States Food and Drug Administration
or its successor agency.
(15)Federal Act--Federal Food, Drug, and Cosmetic
Act (Title 21 U.S.C. 301 et seq.).
(16)Hemp--The plant, Cannabis sativa L. and any part
of that plant, including the seeds of the plant and all derivatives,
extracts, cannabinoids, isomers, acids, salts, and salts of isomers,
whether growing or not, with a delta-9 tetrahydrocannabinol content
concentration level on a dry weight basis, that, when reported with
the accredited laboratory's measurement of uncertainty, produces a
distribution or range that includes a result of 0.3 percent or less.
(17)Independent contractor--A person or entity contracted
to perform work or sales for a registrant.
(18)License holder--The person who is legally responsible
for the operation as a consumable hemp manufacturer, processor, or
distributor, and possesses a valid license.
(19)Lot number--A specific quantity of raw or processed
hemp product that is uniform and intended to meet specifications for
identity, strength, purity, and composition that shall contain the
manufacturer's, processor's, or distributor's, number and a sequence
to allow for inventory, traceability, and identification of the plant
batches used in the production of consumable hemp products.
(20)Manufacturer--A person who makes, extracts, processes,
or distributes consumable hemp product from one or more ingredients,
including synthesizing, preparing, treating, modifying or manipulating
hemp or hemp crops or ingredients to create a consumable hemp product.
For farmers and persons with farm mixed-type facilities, manufacturing
and processing does not include activities related to growing, harvesting,
packing, or holding raw hemp product.
(21)Measurement of uncertainty--The parameter, associated
with the results of an analytical measurement that characterizes the
dispersion of the values that could reasonably be attributed to the
quantity subjected to testing measurement. For example, if the reported
delta-9 tetrahydrocannabinol content concentration level on a dry
weight basis is 0.35% and the measurement of uncertainty is +/- 0.06%,
the measured delta-9 tetrahydrocannabinol content concentration level
on a dry weight basis for this sample ranges from 0.29% to 0.41%.
Because 0.3% is within the distribution or range, the sample is within
the acceptable hemp THC level for the purpose of plan compliance.
(22)Non-consumable hemp processor--A person who intends
to process hemp products not for human consumption and is registered
with the Texas Department of Agriculture.
(23)Non-consumable hemp product--As defined by Texas
Agriculture Code, §122.001(8), means a product that contains
hemp, other than a consumable hemp product as defined by Texas Health
and Safety Code, §443.001. The term includes cloth, cordage,
fiber, fuel, paint, paper, particleboard, construction materials,
and plastics derived from hemp.
(24)Pathogen--A microorganism of public health significance,
including molds, yeasts, Listeria monocytogenes, Campylobacter, Salmonella,
E. coli, Yersinia, or Staphylococcus.
(25)Person--An individual, business, partnership,
corporation, or association.
(26)Process--Extraction of a component of hemp, including
CBD or another cannabinoid, that is:
(A)sold as a consumable hemp product;
(B)offered for sale as a consumable hemp product;
(C)incorporated into a consumable hemp product; or
(D)intended to be incorporated into a consumable hemp
(27)Processor--A person who operates a facility which
processes raw agriculture hemp into consumable hemp products for manufacture,
distribution, and sale. A hemp processor is required to hold a consumable
hemp products license. A person issued a consumable hemp products
license, which only engages in the manufacturing, processing, and
distribution of consumable hemp products, is not required to hold
a license under Texas Health and Safety Code, Chapter 431, Subchapter
(28)QR code--A quick response machine-readable code
that can be read by a camera, consisting of an array of black and
white squares used for storing information or directing or leading
a user to product information regarding manufacturer data and accredited
laboratory certificates of analysis.
(29)Raw hemp--An unprocessed hemp plant, or any part
of that plant, in its natural state.
(30)Registrant--A person, on the person's own behalf
or on behalf of others, who sells consumable hemp products directly
to consumers, and who submits a complete registration form to the
department for purposes of registering their place of business to
sell consumable hemp products at retail to the public.
(31)Reverse distributor--A person registered with
the federal Drug Enforcement Agency as a reverse distributor that
receives controlled substances from another person or entity for return
of the products to the registered manufacturer or to destroy adulterated
or impermissible THC products.
(32)Smoking--Burning or igniting a consumable hemp
product and inhaling the resultant smoke, vapor, or aerosol.
(33)Tetrahydrocannabinol (THC)--The primary psychoactive
component of the cannabis plant.
(34)Texas Department of Agriculture--The state agency
responsible for regulation of planting, growing, harvesting, and testing
of hemp as a raw agricultural product.
(35)Texas.gov--The online registration system for
the State of Texas found at https://www.texas.gov.
The agency certifies that legal counsel has reviewed
the adoption and found it to be a valid exercise of the agency's legal
Filed with the Office
of the Secretary of State on July 13, 2020
Barbara L. Klein
Department of State Health Services
Effective date: August 2, 2020
Proposal publication date: May 8, 2020
For further information, please call: (512) 231-5653