Basis and Purpose - 4015
The statutory authority for this rule includes but is not
limited to sections
44-50-202(1)(b),
44-50-203(1)(b),
44-50-203(1)(f),
44-50-203(1)(n),
44-50-203(2)(d),
44-50-203(2)(g),
and 44-50-404(2),
C.R.S. The purpose of this rule is to establish the required testing and
sampling procedures for Regulated Natural Medicine Product that a Natural
Medicine Products Manufacturer must complete prior to transferring Regulated
Natural Medicine Product.
These testing rules reflect initial rules that attempt to
balance the costs to Natural Medicine Businesses and protecting public health
and safety. These rules are based on limited available data and prior
experience with other similar programs due to the nascent nature of the
Regulated Natural Medicine program. The State Licensing Authority will monitor
testing data and Participant experiences and may revise testing requirements to
require more or less frequent testing, testing for additional or different
contaminants, additional testing requirements if additional routes of
administration are permitted and other testing updates. Further, if additional
Natural Medicines are permitted in the Regulated Natural Medicine program,
those may also require additional testing requirements.
A. Regulated Natural Medicine Product must
pass all required testing conducted by a Natural Medicine Testing Facility
prior to transfer to another Natural Medicine Products Manufacturer, Healing
Center, or Facilitator.
B.
Sampling Procedures.
1.
Production Lots of Regulated
Natural Medicine.
a. A Sample
shall contain at least the number of Sample Increments required by the Division
for a given Production Lot size, as described in the table below.
b. A Sample Increment shall contain at least
one discrete unit that comprises the Production Lot (e.g. one capsule, one
chocolate bar).
c. If the
Production Lot will be transferred in packages that contain more than one Unit,
a Sample shall contain at least two packages.
d. A Sample shall contain at least the
minimum amount of Regulated Natural Medicine Product required by the Natural
Medicine Testing Facility to perform all of the tests requested by the
submitting Natural Medicine Business.
e.
Required Natural Medicine
Product Sampling. See the table below. Minimum Sample Increment =
1 Unit.
|
Number of Units within the Production Lot
|
Minimum Number Sample Increments per
Sample
|
|
0-99
|
5
|
|
100-999
|
8
|
|
1000-4999
|
15
|
|
5000-9999
|
22
|
|
10000-49999
|
33
|
|
50000 or more
|
43
|
2.
Sampling Procedure
Training. A Natural Medicine Products Manufacturer must provide
standard operating procedures and training to any Natural Medicine Handler
Licensee or Owner Licensee who will collect Samples for required testing.
a. The standard operating procedures and
training must include at least the following topics:
i. These Part 4 Rules - Regulated Natural
Medicine Testing Program;
ii.
Sampling procedures or guidance established by the Division, as
available;
iii. Cross contamination
as it relates to Sample collection;
iv. Sample collection documentation and
record keeping requirements; and
v.
Use and disinfection procedures of Sample collection
equipment.
C.
Required Testing - Production
Lot Testing. Prior to transferring any Regulated Natural Medicine
Product, a Natural Medicine Products Manufacturer must comply with required
testing and that testing must be completed with a Sample submitted that is
representative of the Production Lot it came from. The Sample must be of
sufficient size and increments to determine the homogeneity of the product.
1.
Tryptamine Content Analysis
Testing.
a. Each Production Lot
of Regulated Natural Medicine Product must be submitted for tryptamine content
analysis. The results of the tryptamine content analysis required in this Rule
must be accurately documented in the Licensee's inventory tracking records and
on the label prior to transfer to a Facilitator, Natural Medicine Products
Manufacturer, or Healing Center.
i.
Psilocybin;
ii. Psilocin;
iii. Baeocystin;
iv. Aeruginascin; and
v. Norbaeocystin.
b. Each Sample of Regulated Natural Medicine
Product must also be tested for the presence of
4-acetoxy-N,N-Dimethyltryptamine (4-AcO DMT). The presence of any amount of
4-AcO-DMT is considered a failing test.
c.
Failed Testing.
The detection of a synthetic tryptamine or synthetic analog of a tryptamine,
including a derivative of naturally occurring compounds of psilocybin or
psilocin that is produced using chemical synthesis, chemical modification, or
chemical conversion shall constitute a failed tryptamine content analysis
test.
d. Tryptamine content
analysis shall be conducted every nine months from the date of the original
test or most recent retest. When retesting indicates a significant deviation of
Total Psilocin, more than 15% higher or lower than the previous Total Psilocin,
the Regulated Natural Medicine Product must be relabeled with the new
tryptamine content.
2.
Homogeneity. Each Production Lot must be tested to
ensure homogeneous distribution of tryptamines throughout the Production Lot.
For homogeneity testing, a Natural Medicine Products Manufacturer must submit a
minimum of four servings from a minimum of two separate items (e.g. four
capsules of dried, powdered mushrooms or two complete chocolate bars if each
bar contains more than one serving). A Production Lot is considered to have a
homogeneous distribution of tryptamines if each serving of no more than 10
milligrams Total Psilocin that is submitted for homogeneity testing is within
15.0% of the labeled value and the relative standard deviation of the four
servings is less than 15.0%.
3.
Contaminant Testing - Microbial Panel. A Natural
Medicine Products Manufacturer shall subject at least one Production Lot to the
following microbial contaminant testing once every 30-day period following the
Sample submission of the last Sample. If during any 30-day period the Natural
Medicine Products Manufacturer does not possess a Production Lot that is ready
for testing, the Natural Medicine Products Manufacturer must subject its first
Production Lot that is ready for testing to the required contaminant testing
prior to transfer to a Facilitator or Healing Center.
a. Each Sample of Regulated Natural Medicine
Product must be submitted for the following microbial contaminant tests:
i.
Salmonella.
Salmonella must be absent from the Sample.
ii. Shiga toxin producing Escherichia
coli (STEC). STEC must be absent from the
Sample.
