[Federal Register Volume 61, Number 233 (Tuesday, December 3, 1996)]
[Notices]
[Pages 64189-64191]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-30759]


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DEPARTMENT OF TRANSPORTATION
Federal Railroad Administration
[FRA Docket No. RSOR-6, Notice No. 43]
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 currently distributed FRA post-accident toxicology 
testing (PATT) kits contain blood tubes with expiration dates ranging 
from October 1996 to January 1997. Since the blood tube lots that are 
currently available will expire in a few months, FRA decided to delay 
replacing the expiring tubes until new lots of 18-24 month blood tubes 
become available in early 1997. This notice explains the procedures to 
be followed until FRA distributes replacement blood tubes.

FOR FURTHER INFORMATION CONTACT: Lamar Allen, Alcohol and Drug Program 
Manager (RRS-11), Office of Safety, FRA, 400 7th Street, S.W., 
Washington, D.C. 20590 (Telephone: (202) 632-3378) or Patricia V. Sun, 
Trial Attorney (RCC-11), Office of Chief Counsel, FRA, 400 7th Street, 
S.W., Washington, D.C. 20590 (Telephone: (202) 632-3183).

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 individual post-accident kit (there are three kits in each 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. 
On each tube, Becton has printed an expiration date, the date

[[Page 64190]]

until which it warrants that the tube has sufficient vacuum to draw 
blood and chemical additives that remain potent. Becton normally 
releases its blood tubes in lots which expire within 18-24 months of 
manufacture.
    Many of FRA's post-accident kits that have been distributed to 
railroads contain blood tubes that will expire beginning this fall 
(from October 1996 to January 1997). The replacement blood tube lots 
that are now available have only a few months remaining before they 
expire. FRA has decided to delay tube replacement until newly prepared 
18-24 month lots become available in early 1997.

Interim Procedures

    Until the current inventory of blood tubes in the field is replaced 
in early 1997, FRA authorizes railroads to instruct local medical 
personnel to replace the expired tubes with their own stock of 
unexpired 10 mL 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.
    Tube replacement is always preferred to using expired tubes, but, 
if no opportunity for replacement arises, railroads are authorized to 
complete the post-accident collection using the expired blood tubes. 
FRA's post-accident testing program incorporates testing and analysis 
protocols designed to protect employees from unwarranted accusations of 
alcohol or drug use.
    As explained below, grey-top tubes are the only commercial blood 
collection tubes generally available that contain sodium fluoride. They 
are FRA's tubes of choice for FRA's post-accident testing.

Scientific/Technical Issues

    Although FRA's interim procedures require railroads to replace 
expired blood tubes with unexpired tubes if possible, FRA believes that 
use of an expired blood tube, if necessary, will not have a significant 
impact on the validity of post-accident test results. Discussed below 
are the two primary scientific/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. Moreover, a loss of vacuum only affects the efficiency of 
the medical professional's ability to draw a blood specimen from the 
donor. As pressure from the body's circulatory system forces blood into 
the evacuated tube, less vacuum will cause the blood to draw slower or 
not at all.
    Until its expiration date, each grey-top blood tube is warranted by 
Becton to have 90% or more of its vacuum left (at an estimated 
deterioration rate of no greater than 5% per year). If a particular 
tube draws inefficiently due to lack of vacuum, a medical professional 
would ordinarily discard it and simply use another grey-top tube.
    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. In fact, each grey-top blood tube contains sodium fluoride, an 
inorganic substance that contributes to the detectability of parent 
cocaine in blood, by helping to stabilize the spontaneous conversion of 
cocaine in vitro to cocaine metabolites (specifically to ecgonine 
methyl ester, or EME). However, sodium fluoride does not impact either 
the stability or the ability to detect the principal cocaine metabolite 
of interest, benzoylecgonine (BE). Whether the amount of sodium 
fluoride present in grey-top blood tubes is sufficient to retard 
conversion of parent cocaine continues to be a matter of scientific 
interest [see Iscenschmid et al, 1989; Brogan et al, 1992; Baselt et 
al, 1993; others]. Moreover, other factors, including the pH of the 
sample and the temperature of storage, can also affect the stability of 
parent cocaine in blood.
    Since it is an inorganic compound, sodium fluoride oxidizes very 
slowly and in a vacuum environment is unlikely to deteriorate 
dramatically in the first few months after tube expiration. In the 
period between expiration of the older grey-top tubes and replacement 
with new ones, anticipated to be 90 days or less, there will be little, 
if any, significant difference in FRA's ability to detect parent 
cocaine. More importantly, there is no possibility that a ``false 
positive'' for cocaine or any of its metabolites would occur because of 
an expired blood tube.
    Sodium fluoride is also widely established as an effective 
antimicrobial agent in retarding endogenous alcohol production [see 
Harper and Correy, 1988; Anderson and Prouty, 1995; Sulkowski et al, 
1995; and others]. 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, alcohol identical to 
that found in alcoholic beverages may be created. That is, under 
certain extreme conditions, alcohol can appear in an individual's 
urine, blood, or tissues without having been ingested. For alcohol to 
be produced under these circumstances, both glucose and certain 
bacteria or yeast must be present. Other factors, such as the storage 
temperature of the specimen or the condition of the body (if the donor 
is deceased), can also be significant. Obviously, endogenous production 
of alcohol is of concern in the post-accident alcohol testing of both 
surviving and deceased crew members.
    The presence of alcohol-producing bacteria or yeast and glucose in 
a blood sample of a surviving crew member can occur only through a 
combination of disease processes and is extremely rare. Direct 
contamination of a specimen is also extremely unlikely given the 
collection and laboratory protocols of FRA's post-accident testing 
program, and the presence of sodium fluoride in sufficient amounts, 
such as the amounts contained in Vacutainer grey-top collection tubes.
    For surviving crew members, even if the sodium fluoride in the tube 
were rendered totally inert by age, its absence would not be a problem 
unless contaminating bacteria or yeast were present. The blood tube 
itself, with its remaining vacuum, also serves to physically protect 
against that eventuality. In addition, FRA has in the past tested 
specifically for contaminating bacteria or yeast in both the urine and 
the blood, if their presence is suspected.
    For deceased crew members, postmortem alcohol generation is always 
a potential issue when interpreting a positive alcohol result. 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.
    To account for this possibility, 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 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

[[Page 64191]]

or physiological byproducts which can sometimes be present during post-
mortem decomposition; repetitive analyses of a specimen 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, D.C. on November 27, 1996.
Grady C. Cothen,
Deputy Associate Administrator for Safety.
[FR Doc. 96-30759 Filed 12-2-96; 8:45 am]
BILLING CODE 4910-06-P