Iowa Administrative Code › Agency 481 - Inspections and Appeals Department › Inspections Division › Chapter 32 - Consumable Hemp Products › Rule 481-32.1 - Definitions

Current through Register Vol. 47, No. 3, July 24, 2024
For the purpose of these rules, the following terms shall
				  have the meanings indicated in this chapter. The definitions set out in Iowa
				  Code section 204.2 shall be considered to be
				  incorporated verbatim herein.
"Accredited laboratory"
means a laboratory
				  accredited in accordance with the International Organization for
				  Standardization/International Electrotechnical Commission Standard (ISO/IEC)
				  17025 or a comparable or successor standard for the analyses performed on
				  consumable hemp products.
"Adulterated"
means the same as in the
				  Federal Food, Drug, and Cosmetic Act, Section 402, except that a consumable
				  hemp product is not deemed "adulterated" pursuant to this chapter solely
				  because it contains a hemp product not generally recognized as safe by the
				  Federal Food and Drug Administration.
"Approved hemp source "
means a manufacturer
				  of a consumable hemp product that is engaged in the wholesale or retail sale of
				  the product and that is:
1. Located in this state and manufactures the consumable hemp
				  product in compliance with Iowa Code chapter 204 and these rules; or
2. Located in a state that has a state hemp plan approved by
				  the United States Department of Agriculture under 7 U.S.C. Chapter 38,
				  Subchapter VII.
"Cannabidiol"
or
"CBD"
means
				  the specific chemical compound with the Chemical Abstracts Service number
				  13956-29-1.
"Certificate of analysis "
or
"COA
				  "
means an official document released by an accredited laboratory
				  following an analysis of a consumable hemp product. The certificate of analysis
				  shall contain the concentrations of cannabinoids, pesticides, residual
				  solvents, metals, harmful pathogens, and toxicants, including data on levels of
				  total delta-9 tetrahydrocannabinol (THC) content concentration and whether a
				  sample passed or failed any limits related to these analyses.
"Certificate of free sale"
means a
				  government certification that products such as food, drugs, medicine, or
				  cosmetics are approved for unrestricted sale in the jurisdiction in which they
				  originate.
"Consumable hemp establishment"
means an
				  individual or entity engaged in manufacturing, processing, packing, holding,
				  preparing, distributing, or selling a consumable hemp product in Iowa or to
				  purchasers located in Iowa. A consumable hemp establishment does not include an
				  individual or entity manufacturing, processing, packing, holding, preparing,
				  distributing, or selling a consumable hemp product containing only hemp seed or
				  hemp seed-derived food ingredients generally recognized as safe (GRAS) under
				  the conditions of use by the United States Food and Drug Administration.
"Consumable hemp manufacturer"
means a
				  consumable hemp establishment engaged in manufacturing, processing, packing,
				  holding, preparing, distributing, or selling a consumable hemp product on a
				  wholesale basis. A consumable hemp manufacturer includes individuals and
				  entities outside of Iowa that distribute consumable hemp products in Iowa. A
				  consumable hemp manufacturer does not include individuals or entities
				  exclusively engaged in the harvesting, storage, or distribution of raw
				  hemp.
"Consumable hemp product"
means a hemp
				  product that includes a substance that is metabolized or is otherwise subject
				  to a biotransformative process when introduced into the human body.
1. A consumable hemp product may be introduced into the human
				  body by ingestion or absorption by any device including but not limited to an
				  electronic device.
2. A consumable hemp product may exist in a solid or liquid
				  state.
3. A hemp product is deemed to be a consumable hemp product
				  if it is any of the following:
* Designed by the processor, including the manufacturer, to
				  be introduced into the human body.
* Advertised as an item to be introduced into the human
				  body.
* Distributed, exported, or imported for sale or distribution
				  to be introduced into the human body.
4. "Consumable hemp product" includes, but is not limited to,
				  any of the following:
* A noncombustible form of hemp that may be digested, such as
				  food; internally absorbed, such as chew or snuff; or absorbed through the skin,
				  such as a topical application.
* Hemp processed or otherwise manufactured, marketed, sold,
				  or distributed as human food, a human food additive, a human dietary
				  supplement, or a human drug.
5. "Consumable hemp product" does not include a hemp product
				  if the intended use of the hemp product is introduction into the human body by
				  any method of inhalation, as prohibited under Iowa Code section
				  204.14A.
"Consumable hemp retailer"
means a
				  consumable hemp establishment selling consumable hemp product to consumers on a
				  retail basis. A consumable hemp retailer includes an establishment selling
				  consumable hemp products online.
"Delta-9 tetrahydrocannabinol"
or
"THC"
means the specific chemical compound with the Chemical
				  Abstracts Service number 1972-08-3.
"Department"
means the Iowa department of
				  inspections and appeals.
"Expiration date"
means the month and year
				  as determined by the manufacturer, packer, or distributor on the basis of tests
				  showing that the product, until that date, under the conditions of handling,
				  storage, preparation, and use per label directions, will, when consumed,
				  contain not less than the quantity of each ingredient as set forth on its
				  label.
"Food"
means the same as defined in Iowa
				  Code section
				  137F.1. Food includes
				  human dietary supplements and alcoholic beverages.
"Harvesting"
applies to farms and farm
				  mixed-type facilities and means activities that are traditionally performed on
				  farms for the purpose of removing raw agricultural commodities from the place
				  they were grown or raised and preparing them for use as food. Harvesting is
				  limited to activities performed on raw agricultural commodities, or on
				  processed foods created by drying/dehydrating a raw agricultural commodity
				  without additional manufacturing/processing, on a farm. Harvesting does not
				  include activities that transform a raw agricultural commodity into a processed
				  food as defined in Section 201(gg) of the Federal Food, Drug, and Cosmetic Act.
				  Examples of harvesting include cutting (or otherwise separating) the edible
				  portion of the raw agricultural commodity from the crop plant and removing or
				  trimming part of the raw agricultural commodity (e.g., foliage, husks, roots or
				  stems). Examples of harvesting also include cooling, field coring, filtering,
				  gathering, hulling, shelling, sifting, threshing, trimming of outer leaves of,
				  and washing raw agricultural commodities grown on a farm.
"Jurisdiction of origin "
means the federal,
				  state, or local regulatory jurisdiction that has the authority to conduct
				  inspections of the facility in which a consumable hemp product was most
				  recently subject to a manufacturing/processing activity.
"Lot number"
means a specific quantity of
				  raw hemp 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.
"Manufacturing/processing"
means making food
				  from one or more ingredients, or synthesizing, preparing, treating, modifying
				  or manipulating food, including food crops or ingredients. Examples of
				  manufacturing/processing activities include: baking, boiling, bottling,
				  canning, cooking, cooling, cutting, distilling, drying/dehydrating raw
				  agricultural commodities to create a distinct commodity (such as
				  drying/dehydrating grapes to produce raisins), evaporating, eviscerating,
				  extracting juice, formulating, freezing, grinding, homogenizing, irradiating,
				  labeling, milling, mixing, packaging (including modified atmosphere packaging),
				  pasteurizing, peeling, rendering, treating to manipulate ripening, trimming,
				  washing, or waxing. For farms and farm mixed-type facilities,
				  manufacturing/processing does not include activities that are part of
				  harvesting, packing, or holding.
"Misbranded"
means a food that violates
				  21 U.S.C. Section
				  343.
"QR code "
means 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.
"Raw agricultural commodity"
means any food
				  in its raw or natural state, including all fruits that are washed, colored, or
				  otherwise treated in their unpeeled natural form prior to marketing.
"Raw hemp "
means an unprocessed hemp plant,
				  or any part of the hemp plant, in its raw or natural state. Raw hemp is a raw
				  agricultural commodity.
"Tetrahydrocannabinolic acid"
or
"THCA "
means the specific chemical compound with the
				  Chemical Abstracts Service number 23978-85-0.
"Total delta-9 tetrahydrocannabinol"
or
"total THC"
means 87.7 percent of the amount of
				  tetrahydrocannabinolic acid plus the amount of delta-9 tetrahydrocannabinol.