Texas Administrative Code › Title 25 - HEALTH SERVICES › Part 1 - DEPARTMENT OF STATE HEALTH SERVICES › Chapter 300 - MANUFACTURE, DISTRIBUTION, AND RETAIL SALE OF CONSUMABLE HEMP PRODUCTS › Subchapter A - GENERAL PROVISIONS › Section 300.101 - Definitions

Current through Reg. 49, No. 28; July 12, 2024
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 laboratory
											  analysis.
(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 or use.
(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 product.