(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.
(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.
Notes
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
