[Federal Register Volume 66, Number 250 (Monday, December 31, 2001)]
[Notices]
[Pages 67623-67624]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-32048]


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DEPARTMENT OF TRANSPORTATION

Federal Railroad Administration

[FRA Docket No. 2001-11212, Notice No. 1]
RIN 2130-AA81


Alcohol/Drug Regulations: Temporary Post-Accident Blood Testing 
Procedures

AGENCY: Federal Railroad Administration (FRA)

ACTION: Notice.

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SUMMARY: Some of the existing FRA post-accident toxicology testing 
(PATT) kits contain blood tubes with expiration dates ranging from 
December 2001 to May 2002. These expiration dates refer only to the 
vacuum used in the tubes to draw blood. The replacement blood tubes 
that are currently available will also expire in a few months. For this 
reason, FRA will delay replacement of the expiring tubes until 
completely new lots of 18-24 month blood tubes become available in 
early 2002.
    This notice explains the procedures to be followed until the 
replacement of these expiring blood tubes is complete. These temporary 
procedures will not compromise either the quality or integrity of any 
test results.

FOR FURTHER INFORMATION CONTACT: Lamar Allen, Alcohol and Drug Program 
Manager (RRS-11), Office of Safety, FRA, 400 7th Street, SW, 
Washington, DC 20590 (Telephone: (202) 493-6313) or Patricia V. 
Sun,Trial Attorney (RCC-11), Office of Chief Counsel, FRA, 400 7th 
Street, SW, Washington, DC 20590 (Telephone: (202) 493-6060).

Background

    Since 1986, FRA has included Vacutainer brand 10 milliliter (mL) 
evacuated blood collection tubes, manufactured by Becton Dickinson 
(Becton), in its post-accident toxicology testing (post-accident) kits. 
Each of the three individual post-accident kits in a post-accident 
toxicology testing box contains two Vacutainer brand ``grey-top'' glass 
tubes. These tubes, which have no interior coating, contain silicone, a 
rubber stopper lubricant; sodium fluoride, an antibacterial agent and 
mild anticoagulant; and potassium oxalate, an anticoagulant. As 
explained

[[Page 67624]]

below, grey-top tubes are the only commercial blood collection tubes 
generally available that contain sodium fluoride in the preferred 
concentration and are FRA's tubes of choice for FRA post-accident 
testing.
    On each tube, Becton has printed an expiration date, the date until 
which it warrants that the tube has sufficient vacuum to draw blood. 
Becton normally releases its blood tubes in lots which expire within 
18-24 months of manufacture.
    Many of the post-accident kits that have been distributed to 
railroads contain blood tubes that will expire in the next few months 
from November 2001 to May 2002. The replacement blood tube lots that 
are now available have only a few months remaining before their 
warranted vacuum capability expires. FRA has therefore decided to delay 
tube replacement until newly prepared 18-24 month blood tubes become 
available in early 2002.

Interim Procedures

    Until the current inventory of blood tubes in the field is replaced 
in early 2002, FRA authorizes railroads to instruct local medical 
personnel to replace the expired tubes with their own stock of 
unexpired 10 mL, preferably grey-top, tubes. Substituted tubes must be 
10 mL, not the 5 mL type, to ensure sufficient blood for analysis. This 
action is requested, but not required, and need only be considered when 
expired tubes are discovered during an actual post-accident collection. 
Medical facilities maintain supplies of grey-top and other color top 
vacuum tubes for clinical purposes. Tube replacement is always 
preferred to using expired tubes, but, if tube replacement is not 
possible, railroads are authorized to complete the post-accident 
collection using the expired blood tubes.
    This procedure will not lead to an employee being subject to 
venipuncture more than once during a post-accident collection 
procedure. To draw blood specimens, a phlebotomist uses a single needle 
system that permits filling of more than one tube from the same needle 
unit. Use of an older grey-top tube may result in collecting a smaller 
specimen amount in that particular tube, but only if the vacuum in the 
tube, which is the differential between the tube's internal pressure 
and the atmospheric pressure, has been significantly reduced. If this 
should happen, the blood collector will simply replace that blood tube 
with a new tube; no new puncture is necessary.

Scientific and Technical Issues

    Although FRA's interim procedures require railroads to replace 
expired blood tubes with unexpired tubes if possible, the use of an 
expired blood tube will not adversely affect employee rights or impact 
the validity of post-accident test results. FRA's post-accident testing 
program incorporates testing and analysis protocols designed to protect 
employees from unwarranted accusations of alcohol or drug use.
    Discussed below are the two primary scientific and technical issues 
concerning the use of expired tubes: (1) The integrity of the vacuum 
present in the tube to draw blood properly, and (2) the potency of the 
chemical additives.
    Evacuated blood tubes that have recently expired (i.e., within the 
past several months) are not expected to show a dramatic decrease in 
tube vacuum. Until its expiration date, each grey-top blood tube is 
warranted by Becton to have 90% or more of its vacuum remaining at an 
estimated deterioration rate of no greater than 5% per year. This loss 
of vacuum would affect only the efficiency of the medical 
professional's ability to draw a blood specimen. If a particular tube 
draws inefficiently due to lack of vacuum, a medical professional would 
ordinarily discard it and use another grey-top (or other color top) 
tube.
    Since they are inorganic compounds, the preservatives found in the 
tubes, sodium fluoride and potassium oxalate, oxidize very slowly and 
even in a vacuum-decreasing environment, are unlikely to deteriorate 
significantly for many years. More importantly, there is no possibility 
that a ``false positive'' for any drug or its metabolites could occur 
because of an expired blood tube either from vaccum problems or from 
deteriorated preservatives.
    The presence or absence of the chemical additives contained in 
grey-top tubes does not affect the detection of any of the drugs tested 
for in FRA's post-accident testing panel, with the exception of parent 
cocaine. Sodium fluoride in the grey-top tube contributes to the 
detectability of parent cocaine in blood, by helping to stabilize the 
spontaneous conversion of the parent drug in vitro to cocaine 
metabolites. The concentration (or absence) of parent cocaine is 
helpful principally in detecting recency of use.
    Grey-top tubes are also helpful in conducting the alcohol analysis. 
Sodium fluoride is widely established as an effective antimicrobial 
agent in retarding endogenous alcohol production. The production of 
ethyl alcohol in the body is a well known phenomenon, especially in 
post-mortem samples. In the presence of certain contaminating 
microorganisms and extreme conditions, alcohol identical to that found 
in alcoholic beverages may be created by the body after death, causing 
alcohol to appear in certain body fluids and/or tissues without having 
been ingested. Obviously, endogenous production of alcohol is of 
concern in the post-accident alcohol testing of both surviving and 
deceased crew members.
    In FRA's post-accident testing, there have been several cases 
where, given severe trauma and the correct environmental factors, 
alcohol was produced post-mortem in detectable amounts, even in the 
presence of fully potent sodium fluoride. Using grey-topped tubes helps 
in this determination, but FRA has taken and will continue to take 
whatever scientific and technical steps are necessary to protect post-
accident specimen donors from an incorrect interpretation of a positive 
test result. Among the procedures used by FRA to rule out an alcohol 
positive on a deceased employee as coming from endogenous production 
are: examining other tissues or fluids (i.e. urine, brain, vitreous) 
which may have been protected from trauma or decomposition; determining 
that the distribution of alcohol in the various body fluids and tissues 
is inconsistent with that expected in a living person; detecting the 
presence of other volatiles or physiological byproducts which can 
sometimes also be present during post-mortem decomposition; repeating 
analyses of a specimen kept at room temperature to determine if the 
alcohol concentration is increasing; and determining the identity of 
any microorganisms present to assess whether they have alcohol-
producing capability.

    Authority: 49 U.S.C. 20103, 20107, 20111, 20112, 20113, 20140, 
21301, 21304, and 49 CFR 1.49(m).

    Issued in Washington, DC on December 21, 2001.
George A. Gavalla,
Associate Administrator for Safety.
[FR Doc. 01-32048 Filed 12-28-01; 8:45 am]
BILLING CODE 4910-06-P