49 CFR 40.91 - What are the cutoff concentrations for oral fluid drug tests?

View all text of Subpart F [§ 40.81 - § 40.113]

§ 40.91 - What are the cutoff concentrations for oral fluid drug tests?

As a laboratory, you must use the cutoff concentrations displayed in the following table for initial and confirmatory drug tests for oral fluid specimens. All cutoff concentrations are expressed in nanograms per milliliter (ng/mL). The table follows:

Table 1 to § 40.91—Oral Fluid Testing Cutoff Concentrations

Initial test analyte	Initial test cutoff 1	Confirmatory test analyte	Confirmatory test cutoff concentration	Marijuana (THC) 2	4 ng/mL 3	THC	2 ng/mL.	Cocaine/Benzoylecgonine	15 ng/mL	Cocaine Benzoylecgonine	8 ng/mL. 8 ng/mL.	Codeine/Morphine	30 ng/mL	Codeine Morphine	15 ng/mL. 15 ng/mL.	Hydrocodone/Hydromorphone	30 ng/mL	Hydrocodone Hydromorphone	15 ng/mL. 15 ng/mL.	Oxycodone/Oxymorphone	30 ng/mL	Oxycodone Oxymorphone	15 ng/mL. 15 ng/mL.	6-Acetylmorphine	4 ng/mL 3	6-Acetylmorphine	2 ng/mL.	Phencyclidine	10 ng/mL	Phencyclidine	10 ng/mL.	Amphetamine/Methamphetamine	50 ng/mL	Amphetamine Methamphetamine	25 ng/mL. 25 ng/mL.	MDMA 4/MDA 5	50 ng/mL	MDMA MDA	25 ng/mL. 25 ng/mL.

1 For grouped analytes (i.e., two or more analytes that are in the same drug class and have the same initial test cutoff):

Immunoassay: The test must be calibrated with one analyte from the group identified as the target analyte. The cross reactivity of the immunoassay to the other analyte(s) within the group must be 80 percent or greater; if not, separate immunoassays must be used for the analytes within the group.

Alternate technology: Either one analyte or all analytes from the group must be used for calibration, depending on the technology. At least one analyte within the group must have a concentration equal to or greater than the initial test cutoff or, alternatively, the sum of the analytes present (i.e., with concentrations equal to or greater than the laboratory's validated limit of quantification) must be equal to or greater than the initial test cutoff.

2 An immunoassay must be calibrated with the target analyte.

3 Alternate technology (THC and 6-AM): The confirmatory test cutoff must be used for an alternate technology initial test that is specific for the target analyte (i.e., 2 ng/mL for THC, 2 ng/mL for 6-AM).

4 Methylenedioxymethamphetamine (MDMA).

5 Methylenedioxyamphetamine (MDA).

[88 FR 27643, May 2, 2023]