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Historical textIn force on Oct. 1, 2001Source: annual CFR editions 2001–2007

§ 40.95 What criteria do laboratories use to establish that a specimen is adulterated?

Wording in the annual edition revised as of Oct. 1, 2001, superseded by the 2008 annual edition.

govinfo, 2001 edition ↗
Before Jan. 1, 2017 the record is one snapshot per annual CFR edition, revised as of October 1. This is the 2001 edition's wording. An amendment that took effect between Oct. 1, 2001 and Oct. 1, 2001 would not appear until the next edition, so check the citations below and the Federal Register for exact effective dates.
What changedOct. 1, 1996 wording → Oct. 1, 2001 wording+87 added−179 removedHide

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(23) The QAPphysical shallcharacteristics prohibitof the usespecimen ofare anyoutside device that does not pass the specifiednormal qualityexpected controlrange checksfor orhuman that has passed its expiration dateurine.
(b) TheIn manufacturers’making instructionsyour ondetermination orunder includedparagraph in(a) the package for each saliva testing device shall include directions on the proper use of thethis devicesection, theyou time frame within which the device must beapply read and the mannercriteria in whichcurrent theHHS readingrequirements isor made.
(c)specimen Thevalidity employer and its agents shall comply with the QAP and manufacturer's instructions for each non-evidential screening device it uses for alcohol screening tests subject to this Partguidance.

49 CFR § 40.95 — What criteria do laboratories use to establish that a specimen is adulterated?. Text in force on October 1, 2001. This wording effective October 1, 2001 to October 1, 2008. Source: govinfo, 2001 edition, https://www.govinfo.gov/app/details/CFR-2001-title49-vol1/CFR-2001-title49-vol1-sec40-95. Retrieved from FMCSR.com, https://fmcsr.com/reg/40.95?asof=2001-10-01, on October 26, 2026. Unofficial compilation; verify against the official source.

(a) As a laboratory, you must consider the primary specimen to be adulterated if you determine that—

(1) A substance that is not expected to be present in human urine is identified in the specimen;

(2) A substance that is expected to be present in human urine is identified at a concentration so high that it is not consistent with human urine; or

(3) The physical characteristics of the specimen are outside the normal expected range for human urine.

(b) In making your determination under paragraph (a) of this section, you must apply the criteria in current HHS requirements or specimen validity guidance.

Amendment history

4 distinct wordings on file since Oct. 1, 1996
  1. May 2, 2023 → June 1, 2023eCFR, day-precisediff vs. previous
    [73 FR 35970, June 25, 2008]
  2. Oct. 1, 2008 → May 2, 2023annual editions 2008–2016diff vs. previous
    [73 FR 35970, June 25, 2008]
  3. Oct. 1, 2001 → Oct. 1, 2008annual editions 2001–2007diff vs. previousviewing
  4. Oct. 1, 1996 → Oct. 1, 2001annual editions 1996–2000

A new entry appears whenever the regulatory words change between government snapshots. Day-precise from the eCFR (2017 onward); before that, one snapshot per annual CFR edition (revised as of October 1). Bracketed citations are the Federal Register history printed with the section.