Or. Admin. Code § 150-475-6020

Current through Register Vol. 63, No. 11, November 1, 2024

Section 150-475-6020 - Kratom Processor Testing

(1) Finished Processed Kratom Product Batches.

(a) For the purposes of this rule, a "product formulation batch" of finished kratom products means all kratom products of a unique finished kratom product formulation produced on the same day in the same facility by a manufacturer of finished kratom products.

(b) A kratom processor that distributes, sells, or exposes for sale a finished kratom product on a wholesale or retail basis must ensure that each product formulation batch is tested as described in section (3) of this rule.

(2) Unfinished Kratom Product Testing.

(a) A kratom processor processing unfinished kratom must separate the unfinished kratom products into a lot or batch of no more than 1,000 pounds for testing.

(b) A kratom processor that distributes, sells, or exposes for sale unfinished kratom products on a wholesale or retail basis must ensure each batch of unfinished kratom products is tested as described in section (3) of this rule.

(3) Third-Party testing. As required in sections (1)(b) and (2)(b) of this rule, a kratom processor must ensure a minimum of 0.5 percent by volume of each batch of kratom products is tested by a third party to ensure the products do not contain dangerous non-kratom substances. A batch of kratom products must be tested for the following contaminants in a manner consistent with the standards in the referenced administrative rules:

(a) Microbiological contaminants under the standards in OAR 333-007-0390.

(b) Pesticides under the standards in OAR 333-007-0400.

(c) Solvents under the standards in OAR 333-007-0410.

(d) Heavy metals under the standards in OAR 333-007-0415.

(e) Mycotoxins under the standards in OAR 333-007-0425.

(4) Kratom processors must retain records of third-party test results for a period of 3 years from the date of the test results or while the kratom products are in their possession, whichever is longer, and provide the records to the Department upon request. Records may be kept in hard copy or machine-sensible format as those terms are defined in OAR 150-475-2050.

(5) Kratom processor's obligations when product has been tested by another registered Kratom processor.

(a) If a kratom processor acquires finished or unfinished kratom products from a registered Oregon kratom processor at wholesale, and those kratom products have been tested in accordance with section (3) of this rule, the kratom processor wholesaler may satisfy the testing requirements of section (3) of this rule by:

(A) retaining copies of the seller's test results for the previously tested batches purchased by the kratom processor, or;

(B) by retaining invoices for the kratom products that include the Oregon kratom processor's registration certificate number of the seller on the invoice and a statement that all kratom products on the invoice have been tested in accordance with OAR 150-475-6020.

(b) The following examples illustrate the requirements of subsection (a) of this section.

Example 1: Annie, a registered Oregon kratom processor, purchases finished kratom products at wholesale from Brandon, also a registered Oregon kratom processor. Brandon has tested all finished kratom products included in the invoice in accordance with section (3) of this rule and provides Annie with an invoice complete with his registration certificate number and a statement that all kratom products on the invoice have been tested in accordance with OAR 150-475-6020. Annie must retain copies of those invoices and does not need to retest the kratom products to satisfy the requirements of section (3) of this rule. Brandon must retain test results records in accordance with section (4) of this rule.

Example 2: Jake, a registered Oregon kratom processor, purchases finished kratom products at wholesale from Jamie, who is not a registered Oregon kratom processor. Jake must ensure each batch of finished kratom products is tested by a third party in accordance with section (3) of this rule and must retain test results records in accordance with section (4) of this rule.

Example 3: Rachael, a registered Oregon kratom processor, purchases unfinished kratom products from Brandon, also a registered Oregon kratom processor. Subsequently, Rachael converts the unfinished kratom products into finished kratom products. Rachael must ensure each batch of finished kratom products is tested by a third party in accordance with section (3) of this rule and retain test results records in accordance with section (4) of this rule.

(c) Notwithstanding subsection (a) of this section, a Kratom processor may satisfy the requirements of section (3) of this rule by retesting kratom products acquired from a registered Oregon kratom processor. If a kratom processor elects to retest kratom products acquired from another Oregon kratom processor, the kratom processor must retain records of those third-party test results in accordance with section (4) of this rule. A processor that elects to test products that have been previously tested by another Oregon kratom processor under this subsection must test a minimum of 0.5 percent by volume of each finished kratom product formulation or unfinished kratom product from the invoice retained in accordance with section (4) of the rule.

Or. Admin. Code § 150-475-6020

REV 10-2023, adopt filed 05/10/2023, effective 6/1/2023

Statutory/Other Authority: Oregon Laws 2022, chapter 41, section 7

Statutes/Other Implemented: Oregon Laws 2022, chapter 41, section 7 & Oregon Laws 2022, chapter 41, section 3