Utah Admin. Code 70-580-4

Current through Bulletin No. 2024-21, November 1, 2024

Section R70-580-4 - Establishment Registration

(1) Pursuant to Subsection 4-45-104(5), a kratom processor shall register as a food establishment under Section 4-5-301.

(2) A kratom processor may be registered in another state that meets or exceeds the requirements in Section 4-5-301 if they provide the department with a copy of the registration from the federal or state regulatory agency.

(3) A kratom processor shall be subject to any statutes, rules, regulations, policies, and procedures for food establishments specific to the form of the kratom product offered for sale.

(4) In their application for registration, each kratom processor shall identify any DBAs they operate that involve the production of kratom products and the person that is legally responsible to produce the kratom product. If the legally responsible person changes, the department shall be notified of the change within 30 days.

(5) The application for registration shall include a certification that the products manufacturer maintains a manufacturing batch record (MBR) that documents:

(a) batch-to-batch uniformity;

(b) that each batch conforms to kratom raw material specifications;

(c) that each batch record shows that each step of the MBR was performed;

(d) that the production processes, controls, and tests ensure reliable, reproducible results; and

(e) that the finished kratom product meets each specification before the product is released for distribution.

(5) MBR testing shall be performed on finished kratom products as identified by lot or batch number.

(6) Each MBR shall also include the following information:

(a) the lot or batch identification number of the tested product;

(b) the date received;

(c) the date of testing completion;

(d) the method of analysis for each test conducted;

(e) a photo of the kratom product that was tested;

(f) the name and address of the kratom processor that manufactured the product; and

(g) the name and address where the MBR records are maintained and available for inspection by the department.

Utah Admin. Code R70-580-4

Adopted by Utah State Bulletin Number 2021-08, effective 4/2/2021

Amended by Utah State Bulletin Number 2023-06, effective 2/27/2023