![](media/image1.png){width="1.0in" height="1.0in"} **Cold Spring
Construction Co.**

P.O. Box 358 3 Jackson Street Akron, N.Y. 14001

**Tel: (716) 542-2011 Fax: (716) 542-4944**

Federal Register Document Number 04-7984

Public Comment 8400116

July 12, 2004

Comments on Proposed Revisions to Mandatory Guidelines for Federal
Workplace Drug Testing Programs, 69 FR 19673 (April 13, 2004)

Cold Spring Construction Co, with one hundred and fifty employees
working in the states of New York and Pennsylvania, successfully
utilizing Intercept^®^ oral fluid testing for our company's drug-free
workplace program. We are a heavy highway contractor working solely for
the State and the Federal Department of Transportation. Our company
contracts with Lab One to process our Intercept oral fluid specimens.
Since adopting Intercept testing, our company has processed more than
one hundred oral fluid specimens. We have found our Intercept oral fluid
testing program to be a cost-effective, convenient and reliable way to
meet our goals.

We appreciate the opportunity to comment on the proposed revisions to
the Mandatory Guidelines for Federal Workplace Drug Testing Programs,
and we applaud the efforts by HHS to expand the program. We understand
that HHS is making these proposed revisions to fulfill a mandate to
utilize the "best available technology" for drug-free programs. We wish
to comment on three recommendations in the proposed regulations
addressing oral fluid testing.

1\. Proposal for the collection of oral fluid as a "neat" specimen

In section 2.5(b), the collection of oral fluid is specified as **"2mL
collected as a 'neat specimen' (divided as follows: at least 1.5mL for
the primary specimen and at least 0.5mL for the split specimen)."** We
believe that collection of oral fluid using an FDA-cleared collection
device is also an acceptable if not preferred collection method. We have
experience with this method in the collection of over one hundred
specimens.

Spitting into a tube to obtain a "neat" specimen does not necessarily
represent the "best available technology," nor do we believe this
collection method would be practical. Our associates appreciate the
dignity of an oral fluid collection, which we do not believe exists for
donors required to spit into a container. The additional cost and time
required for collecting "neat" specimens could be significant. The
collection environment would require control and possibly sanitizing,
and the allowance of 15 minutes to provide a specimen is five times
longer than the collection process with the FDA-cleared oral specimen
collection device. Specimen collection of oral fluid by an absorbent pad
has been shown to be relatively consistent, and the donor is not able to
control any variances by attempting to dilute or adulterate the sample.

2\. Proposal for collecting a urine specimen with each oral fluid
specimen.

In section 2.3(a) and section 8.3(a)(16) addressing the specific
collection procedures for an oral fluid specimen, it is specified to
also collect a urine specimen, for the purpose of addressing the
possibility of a positive oral fluid test result from passive exposure
to cannabis smoke. We believe this additional specimen collection is
unnecessary and adds unjustified burden and cost for employers.
Scientific data demonstrates that positive oral fluid test results from
any realistic exposure situation would be extremely unlikely.

We would like to alert HHS that since these proposed guidelines were
drafted, authoritative scientific data on the effect of environmental
exposure to cannabis smoke on oral fluid tests has been developed and
accepted by the Journal of Analytical Toxicology for publication (Dr.
Edward Cone et al.). Specifically, this research demonstrates that
environmental contamination is limited to only extreme exposure
conditions (several joints smoked in a small, sealed room), and then for
only short periods after exposure (up to 30 minutes). The likelihood of
environmentally caused positive test results is extremely low if not
negligible.

3\. Applicability of oral fluids testing to return-to-duty, follow-up
testing.

In section 2.2, oral fluid is specified for "**pre-employment, random,
reasonable suspicion/cause and post-accident testing."** Although the
basis for this change was stated as due to the claimed short detection
time for drugs in oral fluids, a review of published data demonstrates
that oral fluid has sensitivities comparable to urine for detection of
drug use in the workplace.

We believe oral fluid testing is appropriate for all testing scenarios.
It is clearly suited for Return-to-Duty and Follow-Up testing, because
it detects recent drug use. A worker successfully completing a substance
abuse recovery program and staying clean from drugs will appropriately
test clean soonest with oral fluid testing.

Oral fluid testing is also uniquely able to detect illicit drug use. A
worker trying to cheat on an SAP's program is very likely to attempt to
tamper with urine specimens by diluting or adulterating them, or by
substituting clean urine. Oral fluid testing provides a directly
observed collection that virtually eliminates the opportunity to tamper
with specimens.

We again thank the Department for this opportunity to provide
information to assist it in drafting and finalizing drug testing
guidelines and for their careful consideration of these points. We are
eager to offer whatever further information and comments that will allow
HHS to fulfill its statutory obligations to "establish comprehensive
standards for all aspects of laboratory drug testing and laboratory
procedures to be applied in carrying out Executive order Numbered 12564,
...including standards which require the use of the best available
technology for ensuring the full reliability and accuracy of the drug
tests ..."

Sincerely,

John L Clancy

Safety Director