This rule requires kratom processors to obtain one of two licenses from the department:
1) a Tier One license, which covers receiving, storing, preparing, transporting, wholesaling, and manufacturing finished products; and
2) a Tier Two license, which covers selling finished products to a retailer and minimal processing for storage only.
Processors must operate licensed facilities that meet basic cleanliness standards, prohibit residential use, and comply with federal and state hazardous waste laws for disposal.
This rule establishes testing requirements, mandating that a third-party laboratory tests every product lot for alkaloids, pesticides, microbials, heavy metals, and foreign matter before distribution.
The department conducts random testing and may have access to facilities, materials, and records for inspection and sampling.
Processors keep detailed records for a minimum of three years, documenting material receipt, processing batches, testing results, and product disposition.
Furthermore, this rule specifies secure storage for kratom material, separate from other manufactured products with access limited to employees, and requires a transport manifest detailing COA, location, licensure, and a bill of lading for every movement of kratom material.
Finally, the department immediately revokes a processor's license and refers the case to law enforcement if a final product tests at 0.4% or greater of 7-hydroxymitragynine.