Federal Register / Vol. 66, No. 250 / Monday, December 31, 2001 / Notices 67623

CFR section Respondent universe Total annual responses Average time per response

Total annual burden hoursTotal annual burden cost

238.109—Employee Training .. 14 Railroads .......... 3,900 Employees ..................... 2 hours ..................................... 7,800 232,500

—Recordkeeping .............. 14 Railroads .......... 2,500 Records ......................... 3 minutes ................................. 125 4,250

238.111—Pre-Rev. Service

Test Plan.

10 Equip Man. ...... 4 Plans ..................................... 16 hours ................................... 64 4,288

—Pre-Rev. Service Test

Plan.

10 Equip Man ....... 4 Plans ..................................... 200 hours ................................. 800 69,440

Subsequent Orders .......... 10 Equip Plan ....... 4 Plans ..................................... 60 hours ................................... 240 18,720

238.203—Static End Strength 14 Railroads .......... 1 Petition .................................. 100 hours ................................. 100 5,500

—Comments ..................... 14 Railroads .......... 6 Comments ............................ 20 hours ................................... 120 6,600

238.237—Auto Monitoring ....... 14 Railroads .......... 14 Documents ......................... 2 hours ..................................... 28 952

—Tags .............................. 14 Railroads .......... 100 Tags .................................. 3 minutes ................................. 5 225

238.303—MU Locos Inop.

Brakes.

14 Railroads .......... 50 Tags/cards .......................... 3 minutes ................................. 3 135

—Conv. Locomotive ......... 14 Railroads .......... 50 Tags/cards .......................... 3 minutes ................................. 3 135

—Written Notices .............. 14 Railroads .......... 25 Written Notices ................... 3 minutes ................................. 1 34

—Records ......................... 14 Railroads .......... 2,017,756 Records .................. 1 minute ................................... 33,629 1,143,386

238.305—Int. Calendar Day

Insp.

14 Railroads .......... 480 Tags .................................. 1 minute ................................... 8 288

—Records ......................... 14 Railroads .......... 1,866,904 Records .................. 1 minute ................................... 31,115 1,057,910

238.307—Periodic Mech

Insp.—p/cars.

14 Railroads .......... 5 Notifications .......................... 3 hours ..................................... 25 850

—Records ......................... 14 Railroads .......... 56,462 Records ....................... 2 minutes ................................. 941 63,988

—Detailed Docs ................ 14 Railroads .......... 5 Documents ........................... 100 hours ................................. 500 17,000

238.311—Single Car Test ....... 14 Railroads .......... 25 Tags .................................... 3 minutes ................................. 1 36

238.315—Class IA—Brake

Pressure.

14 Railroads .......... 365,000 Communications ........ 3 seconds ................................ 304 0

—Comm Signal Sys ......... 14 Railroads .......... 365,000 Tests .......................... 15 seconds .............................. 1,521 0

238.317—Class II Brake Test 14 Railroads .......... 365,000 Communications ........ 3 seconds ................................ 304 0

—Signal Sys ..................... 14 Railroads .......... 365,000 Tests .......................... 15 seconds .............................. 1,521 50

238.431—Brake System .......... 14 Railroads .......... 1 Analysis ................................ 40 hours ................................... 40 1,360

238.437—Emerg Communication.3 Car Manuf .......... 3 instr. Sets/2250 decals ......... 25 hours/10 min ....................... 117 3,810

238.441—Emerg. Roof Entrance Loc.3 Car Manuf .......... 3 instr. Sets/250 placards ........ 25 hours/1 hour ....................... 325 10,050

238.445—Auto. Monitoring ...... 1 Railroad ............. 10,000 Alerts ........................... 10 seconds .............................. 28 0

—Self-Test Feature .......... 1 Railroad ............. 21,900 Notification ................... 20 seconds .............................. 122 0

Total Responses: 5,442,514.

Estimated Total Annual Burden:

83,417 hours.

Status: Regular Review.

Pursuant to 44 U.S.C. 3507(a) and 5

CFR 1320.5(b), 1320.8(b)(3)(vi), FRA

informs all interested parties that it may

not conduct or sponsor, and a

respondent is not required to respond

to, a collection of information unless it

displays a currently valid OMB control

number.

Authority: 44 U.S.C. 3501–3520.

Kathy A. Weiner,

Director, Office of Information Technology

and Support Systems,Federal Railroad

Administration.

[FR Doc. 01–32018 Filed 12–28–01; 8:45 am]

BILLING CODE 4910–06–P

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.

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 ‘‘greytop’’ 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

67624 Federal Register / Vol. 66, No. 250 / Monday, December 31, 2001 / Notices

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 postaccident 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 postaccident test results. FRA’s postaccident 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 greytop 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 greytopped 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

DEPARTMENT OF TRANSPORTATION

Maritime Administration

Docket Number MARAD–2001–

11241Requested Administrative Waiver

of the Coastwise Trade Laws

AGENCY: Maritime Administration,

Department of Transportation.