[Federal Register Volume 78, Number 43 (Tuesday, March 5, 2013)]
[Rules and Regulations]
[Pages 14217-14225]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-05010]


=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF TRANSPORTATION

Federal Railroad Administration

49 CFR Part 219

[Docket No. FRA-2010-0155]
RIN 2130-AC24


Control of Alcohol and Drug Use: Addition of Post-Accident 
Toxicological Testing for Non-Controlled Substances

AGENCY: Federal Railroad Administration (FRA), Department of 
Transportation (DOT).

ACTION: Final rule.

-----------------------------------------------------------------------

SUMMARY: In 1985, FRA implemented a post-accident toxicological testing 
(post-accident testing) program to test railroad employees who had been 
involved in serious train accidents for alcohol and certain controlled 
substances (marijuana, cocaine, phencyclidine (PCP), and selected 
opiates, amphetamines, barbiturates, and benzodiazepines). This final 
rule adds certain non-controlled substances with potentially impairing 
side effects to its standard post-accident testing panel. The non-
controlled substances include tramadol and sedating antihistamines. 
This final rule makes clear that FRA intends to keep the post-accident 
test results for these non-controlled substances confidential while it 
continues to obtain and analyze data on the extent to which 
prescription and over-the-counter (OTC) drug use by railroad employees 
potentially affects rail safety.

DATES: This rule is effective on May 6, 2013. Petitions for 
reconsideration must be received on or before May 6, 2013. Petitions 
for reconsideration will be posted in the docket for this proceeding. 
Comments on any submitted petition for reconsideration must be received 
on or before June 18, 2013.

ADDRESSES: Petitions for reconsideration or comments on such petitions: 
Any petitions and any comments to petitions related to Docket No. FRA-
2010-0155, may be submitted by any of the following methods:
     Online: Comments should be filed at the Federal 
eRulemaking Portal, http://www.regulations.gov. Follow the online 
instructions for submitting comments.
     Fax: 202-493-2251.
     Mail: Docket Management Facility, U.S. DOT, 1200 New 
Jersey Avenue SE., W12-140, Washington, DC 20590.
     Hand Delivery: Room W12-140 on the Ground level of the 
West Building, 1200 New Jersey Avenue SE., Washington, DC between 9 
a.m. and 5 p.m. Monday through Friday, except federal holidays.
    Instructions: All submissions must include the agency name and 
docket number or Regulatory Identification Number (RIN) for this 
rulemaking. All petitions and comments received will be posted without 
change to http://www.regulations.gov; this includes any personal 
information. Please see the Privacy Act heading in the ``Supplementary 
Information'' section of this document for Privacy Act information 
related to any submitted petitions or materials.
    Docket: For access to the docket to read background documents or 
comments received, go to http://www.regulations.gov at any time or to 
Room W12-140 on the Ground level of the West Building, 1200 New Jersey 
Avenue SE, Washington, DC between 9 a.m. and 5 p.m. Monday through 
Friday, except Federal holidays.

FOR FURTHER INFORMATION CONTACT: Patricia V. Sun, Trial Attorney, 
Office of Chief Counsel, Mail Stop 10, FRA, 1200 New Jersey Avenue SE. 
Washington, DC 20590 (telephone 202-493-6060), patricia.sun@dot.gov.

SUPPLEMENTARY INFORMATION:

The NPRM

    In 1985, to further its accident investigation program, FRA began 
conducting alcohol and drug tests on railroad employees who had been 
involved in serious train accidents that met its specified criteria for 
post-accident testing (see 49 CFR 219.201). Since the program's 
inception, FRA has routinely conducted post-accident tests for alcohol 
and for certain drugs classified by the Drug Enforcement Administration 
(DEA) as controlled substances because of their potential for abuse or 
addiction. See the Controlled Substances Act (CSA), Title II of the 
Comprehensive Drug Abuse Prevention Substances Act of 1970 (CSA, 21 
U.S.C. 801 et seq.). As noted in the NPRM, FRA has historically 
conducted post-accident tests for alcohol and marijuana, cocaine, 
phencyclidine (PCP), and certain opiates, amphetamines, barbiturates, 
and benzodiazepines. The purpose of these tests is to determine if 
alcohol misuse or drug abuse played a role in the occurrence or 
severity of an accident.
    On May 17, 2012, FRA proposed to add routine post-accident tests 
for certain non-controlled substances with potentially impairing side 
effects (77 FR 29307). As discussed in the NPRM, studies have shown a 
significant increase in the daily use of prescription drugs, OTC drugs, 
vitamins, and herbal

[[Page 14218]]

and dietary supplements by both railroad workers and the general 
population. Although most prescription drugs and all OTC drugs are non-
controlled substances, many commonly used ones, such as antihistamines 
and muscle relaxants (e.g., tramadol), carry warning labels against 
driving or moving heavy machinery because of their potential sedating 
effects. Furthermore, even prescription and OTC drugs that do not carry 
such warnings can have unintended side effects when taken in 
combination with other drugs, when not used in accordance with 
directions, or when a user has an unusual reaction.
    In the NPRM, FRA discussed testing for two non-controlled 
substances: (1) Tramadol, which is available only by prescription, and 
(2) sedating antihistamines, which are available at both prescription 
and OTC dosages. FRA asked for comment on how the agency should handle 
test results for these first non-controlled substances to be tested for 
routinely in its post-accident testing program. In the NPRM, FRA 
proposed to continue its research testing related to sedating 
antihistamines and keep the test results confidential and not report to 
the relevant railroad or employee any sedating antihistamine post-
accident test results. In the NPRM, FRA noted that although tramadol is 
a non-controlled substance, it is a prescription-only semi-synthetic 
opioid that can cause dizziness, and sought comment on how it should 
handle tramadol post-accident test results. FRA specifically requested 
comment as to whether the agency should release post-accident test 
results for tramadol as it does for other opioids that are controlled 
substances.
    The NPRM also contained two announcements. To make its post-
accident testing requirements and procedures easier to understand, FRA 
announced that its standard post-accident testing box would include new 
information and an updated and simplified form and instructions. FRA 
also announced that it was amending Appendix B to 49 CFR part 219 to 
designate Quest Diagnostics in Tucker, Georgia as its post-accident 
testing laboratory.

Comments on the NPRM

    FRA received seven comments on the NPRM. FRA received comments from 
the Association of American Railroads (AAR), the American College of 
Occupational and Environmental Medicine (ACOEM), and a joint submission 
from the American Train Dispatchers Association, the Brotherhood of 
Locomotive Engineers and Trainmen, the Brotherhood of Maintenance of 
Way Employes Division, the Brotherhood of Railroad Signalmen, and the 
United Transportation Union (collectively referred to as ``Rail 
Labor''); with the Transportation Trades Division, AFL-CIO filing a 
comment in support. FRA also received individual comments from three 
health care professionals (HCPs). FRA addresses the common issues 
raised by the commentators below instead of addressing each comment 
separately.

The Addition of Post-Accident Tests for Tramadol and Sedating 
Antihistamines

    Comment was divided on FRA's proposal to add routine post-accident 
tests for non-controlled substances such as tramadol and sedating 
antihistamines. Rail Labor representatives, who were uniformly opposed, 
asserted that conducting post-accident tests for legal drugs would 
discourage railroad employees from using necessary prescription and OTC 
drugs, and that the resulting risks from untreated medical conditions 
could outweigh the possible adverse effects from the medications used 
to treat them. Rail Labor representatives also stressed the privacy 
interests employees have in their medical information and expressed 
concerns that the release of positive test results for sedating 
antihistamines could cause an employee to suffer discipline or 
dismissal for the use of a legal substance. The AAR supported FRA's 
proposal, and the ACOEM was strongly in favor of post-accident testing 
for non-controlled substances as a necessary first step in increasing 
employee and employer awareness of the risks of unintended drug 
interactions from polypharmacy (the use of multiple prescription and 
OTC drugs). The HCPs who submitted comments had varied views. One HCP 
supported the addition of sedating antihistamines, but not tramadol, 
because the HCP considered it to be a ``mild opioid.'' Another HCP 
supported the addition of both substances because of their tendency to 
induce drowsiness, but added that FRA needed to address the issue of 
fatigue among railroad workers. A third HCP, noting that any substance, 
including water, can be problematic if taken incorrectly or in too 
large amounts, questioned how FRA had selected tramadol and the four 
sedating antihistamines mentioned in the NPRM for post-accident 
testing.
    Some commentators questioned whether FRA had proven that post-
accident testing for non-controlled substances was necessary. Rail 
Labor pointed out that the independent studies FRA cited in the NPRM 
(Slone Epidemiology Center at Boston University, Patterns of 
Medications Use in the United States (2006), and National Community 
Pharmacists Association, Take as Directed: A Prescription Not Followed 
(2006)) concerned the prevalence of prescription and OTC drug use among 
the population in general, and not railroad workers in particular. An 
HCP also expressed the view that FRA had not shown that medication use 
was prevalent in the rail industry.
    FRA notes that commenters provided no evidence that the use of 
prescription and OTC drugs by the railroad employee population is 
different than that of the general population studied in Slone and 
National Community. In 2006, FRA published a study that it had 
commissioned from Foster-Miller, Inc. (GERTLER, J., HARTENBAUM, N., MD, 
VIALE, A., WITTELS, E., MD, S. ELLIS, ESQ. (2005) MEDICAL STANDARDS FOR 
RAILROAD WORKERS), which found over 60 percent of U.S. railroad workers 
to be males between 45-64 years of age. That same year, Slone found 
that 30 percent of men between 45-64 years old self-reported using five 
or more prescription and OTC drugs in a week, while the corresponding 
figure for men between 18-44 years old was only eight percent. Slone 
concluded that the nearly one third of older men who use at least five 
drugs a week are at greater risk for unintended drug interactions.
    Moreover, FRA's own research studies provided anecdotal evidence of 
multiple drug use among railroad employees. As discussed in the NPRM, 
from April 2002 to April 2009, FRA asked railroad employees who had 
been involved in reportable (see FRA's accident reporting regulations 
at 49 CFR part 225) human-factor accidents to complete surveys on their 
recent prescription and OTC drug use. In eighty percent of the 294 
railroad accidents at least partially attributed to human error during 
this period, one or more of the employees involved reported using at 
least one generic or brand name drug, and many employees reporting the 
use of multiple substances, including not only prescription and OTC 
drugs, but also herbal remedies and dietary supplements. FRA believes 
the actual use of prescription and OTC drugs by railroad employees is 
likely higher than that indicated in these self-reports, since some 
survey respondents may have omitted or forgotten drugs that they had 
used.
    Rail Labor representatives commented that FRA had no data linking 
the use of tramadol or sedating antihistamines to an increased risk of 
rail accidents,

[[Page 14219]]

whether due to an adverse side effect of the drug or an employee's 
failure to comply with HCP or manufacturer directions. This is correct. 
As FRA noted in the NPRM, FRA proposes to conduct post-accident testing 
for tramadol and sedating antihistamines for research purposes only to 
obtain such data and to determine whether their use presents a safety 
issue in the railroad industry. While the addition of any drug to FRA's 
post-accident testing panel indicates that the drug is of safety 
concern to FRA, FRA's purpose in adding routine post-accident tests for 
non-controlled substances is to obtain data, not to deter the use of 
legal drugs by railroad employees. FRA would not be fulfilling its 
accident investigation mission if it did not research the impact of 
legal drugs on the occurrence or severity of significant rail 
accidents, including the potential risks of using drugs with known 
adverse effects and the potential risks of using multiple prescription 
and OTC drugs which may cause unintended drug interactions.
    One HCP cited several studies on the sedating effects of various 
antihistamines and asked how FRA decided to select diphenhydramine, 
chlorpheniramine, bromenphiramine, and doxylamine for post-accident 
testing. To clarify, FRA listed these drugs simply as examples, and not 
as an exhaustive list, of the sedating antihistamines that would be 
added to FRA's drug panel. As stated in the NPRM, the sedating 
antihistamines category ``includes, but is not limited to, 
diphenhydramine, chlorpheniramine, bromenphiramine, and doxylamine'' 
(77 FR at 29308, emphasis added). As explained below, the purpose of 
FRA post-accident testing is to obtain data on the potential causes of 
major railroad accidents. FRA's ability to do so would be hampered if 
it could only post-accident test for four of the drugs in the sedating 
antihistamine class.
    FRA is selecting tramadol and sedating antihistamines, both of 
which can cause drowsiness, as the initial non-controlled substances to 
be added to its standard post-accident testing panel. The widely used 
painkiller tramadol is a synthetic opioid similar to other synthetic 
opioids such as the controlled substances oxycodone and methadone. The 
use of sedating antihistamines, which is even more common, has been 
studied by the National Highway Traffic Safety Administration (NHTSA), 
which expressed concerns that ``first generation antihistamines produce 
objective signs of skills performance impairment as well as subjective 
symptoms of sedation.'' See MOSKOWITZ AND WILKINSON, ANTIHISTAMINE AND 
DRIVING-RELATED BEHAVIOR: A REVIEW OF THE EVIDENCE FOR IMPAIRMENT 
(2004). As explained in the NPRM, the addition of tramadol and sedating 
antihistamines to FRA's standard post-accident drug panel does not 
limit FRA's ability to conduct post-accident tests for other non-
controlled substances, whether to investigate an individual accident or 
to conduct additional research.

The Reporting of Post-Accident Test Results for Non-Controlled 
Substances

    As noted above, in the NPRM, FRA asked for comment on how it should 
handle post-accident test results for non-controlled substances such as 
sedating antihistamines and tramadol. Comment was divided on the issue 
of whether FRA should report tramadol post-accident test results. Rail 
Labor representatives and one HCP objected to the release of results 
for tramadol, on the grounds that it is a mild opioid that is not a 
controlled substance. Conversely, the AAR argued that as the primary 
guardians of rail safety, railroads had a need to know both tramadol 
and sedating antihistamines results to be able to address any concerns 
that could affect safe operations. With the exception of the AAR, all 
commentators supported FRA's proposal to continue the practice of not 
reporting post-accident test results for sedating antihistamines.
    After reviewing the comments, FRA has decided to maintain its 
proposal to treat post-accident test results for non-controlled 
substances (including sedating antihistamines and tramadol) 
confidential. To this end, FRA is revising the regulatory text of Sec.  
219.211(b) as proposed in the NPRM to limit the reporting of post-
accident testing results to results for controlled substances only. An 
employee's use of a non-controlled substance is legal and generally 
subject to few restrictions, and FRA is not convinced at this time that 
a railroad has a safety need to know whether an employee is using a 
non-controlled substance while subject to performing covered service. 
Thus, FRA will not report non-controlled substance post-accident test 
results to the railroads. FRA will report a post-accident test result 
for a non-controlled substance to an employer or a third party only if 
an employee has provided specific written consent for release of his or 
her test result to the employer or third party. (As has been its 
standard practice, FRA may also provide post-accident test results and 
post-mortem specimens to the National Transportation Safety Board upon 
request. See Sec.  219.211(f) and (h).) Except for these limited 
circumstances, all post-accident test results for non-controlled 
substances will be kept confidential. FRA will, however, continue to 
monitor its post-accident test results and other data to see if changes 
in policy or additional action are needed.

The Nature of FRA Post-Accident Testing

    Several comments concerned both the addition of non-controlled 
substances to post-accident tests and FRA post-accident testing in 
general. An HCP commented that since the purpose of post-accident 
testing is to prevent accidents, FRA would better address non-
controlled substance use by expanding the scope of its prohibitions 
instead of its post-accident testing program. Rail Labor 
representatives commented that FRA post-accident testing was exempt 
from DOT testing procedures (see Procedures for Transportation 
Workplace Drug and Alcohol Testing Programs (49 CFR part 40)) only by 
``dint of history,'' and that the proposed addition of non-controlled 
substances would make FRA's post-accident testing panel inconsistent 
with the drug panels used by other DOT programs. To address these 
comments, some of which reflect misperceptions of the nature and 
history of the program, FRA is providing an overview of the program's 
fundamentals.
    While the purpose of other DOT agency workplace testing programs is 
to detect or deter drug abuse, the purpose of FRA post-accident testing 
is not to prevent, but to investigate the causes of significant 
railroad accidents and incidents; this is why the FRA's post-accident 
testing program has always tested for more controlled substances (e.g., 
barbiturates and benzodiazepines) than do other DOT agency testing 
programs. Furthermore, an examination of the history of FRA post-
accident testing reveals that the program's exemption from part 40 
coverage was deliberate. FRA pioneered transportation workplace testing 
(see Final Rule implementing FRA reasonable suspicion and post-accident 
testing, 50 FR 31508, August 2, 1985), and the Supreme Court upheld the 
Constitutionality of both programs in Skinner v. RLEA, 489 U.S. 602, 
109 S. Ct. 1402 (1989). Congress took notice of this Court decision two 
years later when it enacted the Omnibus Transportation Employee Testing 
Act of 1991 (``Omnibus Act,'' Pub. L 102-143, Oct. 28, 1991), by 
specifically exempting FRA post-accident testing from the Act, which 
required DOT and six of its operating administrations to implement

[[Page 14220]]

transportation workplace testing programs in accordance with standards 
set by the Department of Health and Human Services (HHS). DOT in turn 
exempted FRA post-accident testing from its part 40 procedures (see 
Sec.  40.1(c)), which implemented the Omnibus Act's mandates and govern 
all other types of FRA and DOT testing.
    Although FRA encourages railroad employees to seek drugs with fewer 
potential side effects, FRA does not believe the addition of non-
controlled substances to post-accident tests will discourage employees 
from seeking necessary treatment. As stated above, FRA will not report 
post-accident test results for non-controlled substances except with 
the permission of the employee. Moreover, the average employee will 
finish his or her railroad career without ever being required to 
provide post-accident test specimens. The number of post-accident tests 
conducted annually is only a fraction of the total number of FRA drug 
and alcohol tests conducted each year, because post-accident tests are 
conducted only on employees involved in rail accidents or incidents 
that meet FRA's criteria for a ``qualifying event'' (see the four types 
of qualifying events described in Sec.  219.201). In 2011, for example, 
there were only 87 qualifying events in which a total of 195 railroad 
employees were post-accident tested. This means that 195 post-accident 
drug tests and 195 post-accident alcohol tests were administered in 
2011, while during that same year a total of 34,093 random drug tests 
and 42,289 random alcohol tests were administered to railroad 
employees. As previously mentioned, FRA has designated Quest 
Diagnostics as its post-accident testing laboratory. Again unlike other 
workplace testing programs, FRA post-accident testing specimens are 
analyzed only at a single laboratory. To be awarded the contract as 
FRA's designated post-accident testing laboratory, a laboratory must be 
able to meet not only the technical qualifications for HHS laboratory 
certification but also qualifications set by FRA specifically for its 
post-accident testing program. These include the capability to analyze 
a wider variety of specimens (unique among DOT testing programs, FRA 
post-accident tests blood from surviving employees and tissue and fluid 
specimens from fatalities), for a wider variety of substances (e.g., 
barbiturates, carbon monoxide) at lower levels of detection than other 
HHS-certified laboratories. FRA audits the post-accident laboratory's 
compliance and quality each quarter.
    Rail Labor representatives also expressed misgivings related to 
railroad availability policies, unpredictable work schedules, and FRA 
post-accident testing cutoffs. Their concern was that a railroad 
employee could test above the cutoff for tramadol or a sedating 
antihistamine if the employee used the substance, received an 
unexpected call for duty, and was later involved in an accident or 
incident that qualified for post-accident testing. For the reasons 
outlined below, FRA believes this misgiving is unfounded.
    FRA has consulted with forensic toxicologists to establish post-
accident screening and confirmation cut-offs for tramadol and sedating 
antihistamines, as appropriate for purposes of accident investigation. 
The purpose of random and other types of workplace tests is to detect 
whether a substance or its metabolite in present in an employee's 
system, with the ultimate goal of deterring or detecting substance 
abuse. This is not the case with FRA post-accident testing. With the 
exception of major train accidents, where all crew members involved 
must be tested, a railroad supervisor on the scene must make a good 
faith determination that an employee may have played a role in the 
cause or severity of an accident before the employee is post-accident 
tested. When a significant accident occurs, the special features of the 
program--the requirement to collect blood from surviving employees, the 
requirement to collect and test specimens from fatalities, the 
requirement to use only FRA-issued specimen collection kits and forms, 
the requirement to follow FRA-only collection procedures, the 
requirement that all specimens be shipped to a single laboratory for 
analysis, the requirement that this laboratory exceed the 
qualifications for HHS certification, and the requirement that all test 
results be reviewed by FRA, which has sole control over whether they 
are reported to employees and employers--enable FRA to collect data as 
one part of its investigation of the cause of the accident. (See 
Appendix C to 49 CFR part 219.) Because the ultimate purpose of FRA's 
post-accident testing program is to determine the cause of an accident, 
an employee's post-accident test result is just one of the many things 
FRA investigates. The mere presence of a substance or metabolite in an 
employee's system is never considered in isolation and FRA retains 
control of all post-accident specimens and results to ensure that a 
post-accident test result is interpreted in the context of the overall 
investigation.
    Accidents can occur at any time, under different circumstances, and 
for a variety of reasons. For this reason FRA will maintain its 
practice of adjusting the substances, cutoffs and protocols in its 
post-accident testing program without notice and as it has done since 
the program's inception. When a major accident happens, FRA cannot wait 
for notice and comment before deciding whether to test for a substance 
that is not on its routine post-accident testing panel if preliminary 
investigation shows the substance may have played a role in the 
accident's occurrence or severity. Publication of this final rule 
provides notice that FRA will routinely conduct post-accident tests for 
non-controlled substances but does not provide precedent that FRA will 
publish notice of future changes to its post-accident testing program.
    Rail Labor representatives also questioned why FRA was proposing to 
add post-accident tests for prescription and OTC drugs, given the 
conclusions of a Working Group tasked by the Railroad Safety Advisory 
Committee (RSAC) to develop Medical Standards (Task Number 2006-03, 
Medical Standards for Safety-Critical Personnel). According to these 
commentators, the Working Group had concluded ``that regulatory 
treatment of such usage [of prescription drugs, OTC drugs, dietary 
supplements, and herbal remedies] is inappropriate * * * and that FRA's 
current Safety Advisory [Safety Advisory 98-3, Recommended practices 
for the safe use of prescription and over-the-counter drugs by safety-
sensitive railroad employees, 63 FR 71334, December 24, 1998] continues 
to sufficiently address recommended practices for safe use of 
prescription and OTC drugs.'' FRA believes that this characterization 
by these commentators is incorrect since the Medical Standards Working 
Group has made no consensus recommendations to the RSAC about the use 
of medications by safety-sensitive employees and Task 2006-03 remains 
open.
    Finally, with regard to Safety Advisory 98-3, FRA notes that the 
stated purpose of that Advisory remains as important today as it was 
when the Advisory was issued--i.e., the recommendations in that 
Advisory are intended to ensure that transportation employees safely 
use prescription and OTC drugs. In that Advisory, FRA specifically 
noted that ``FRA does not have a clear picture of the extent to which 
the performance of safety-sensitive employees is adversely affected by 
legal drug use.'' FRA's promulgation of this final rule adding certain 
non-controlled substances to its standard post-accident testing panel 
is one step toward FRA's longstanding

[[Page 14221]]

goal of determining whether the performance of safety-sensitive 
employees is adversely affected by the use of prescription and OTC 
drugs.

Contents of Standard Post-Accident Testing Box

    As announced in the NPRM, FRA is amending the contents of its 
standard post-accident testing box. FRA is adding guidance on the 
basis, purpose, and requirements of its post-accident testing program 
and updating the information requests in FRA F 6180.74, Post-Accident 
Testing Blood/Urine Custody and Control Form. These amendments should 
make FRA's post-accident testing collection and shipping requirements 
easier to understand and follow. (FRA is not changing the contents of 
its fatalities post-accident testing box or changing the other form in 
its standard post-accident testing box, Form FRA F 6180.73, Accident 
Information Required for Post-Accident Toxicological Testing.)

Section-by-Section Analysis

Section 219.5--Definitions

    FRA received no comment on its proposed definition of a non-
controlled substance and is adding the definition as proposed.

Section 219.13--Preemptive Effect

    FRA received one comment from an HCP who supported removal and 
reservation of this section. As proposed, FRA is removing the 
preemption language in paragraph (a) of this section because part 219 
has preemptive effect by operation of law under the Federal Rail Safety 
Act (FRSA). See 49 U.S.C. 20106. Also as proposed, FRA is moving the 
language in paragraph (b) of this section to a new paragraph (c) of 
Sec.  219.17.

Section 219.17--Construction

    As discussed in the paragraph above and as proposed in the NPRM, 
FRA is adding a new paragraph (c) to this section to replace the 
language formerly contained in Sec.  219.13(b). This new paragraph 
states that part 219 does not impact State criminal laws imposing 
sanctions for reckless conduct that leads to actual loss of life, 
injury, or damage to property, whether such provisions apply 
specifically to railroad employees or the public at large.

Section 219.211--Analysis and Follow-Up

    As proposed in the NPRM, in the second sentence of paragraph (a), 
FRA is replacing the phrase ``alcohol and controlled substances 
specified by FRA'' with ``alcohol, controlled substances, and non-
controlled substances specified by FRA'' to accommodate the addition of 
routine testing for non-controlled substances to its post-accident 
testing program. As also proposed in the NPRM, FRA is deleting the 
reference to submittal of FRA post-accident testing protocols to HHS, 
since as detailed above, HHS standards do not apply to FRA post-
accident testing and FRA is adopting language from the DEA by adding a 
sentence stating that substances may be tested for in any form, whether 
naturally or synthetically derived, since controlled substances can be 
derived from many sources (e.g., opiates can be natural, synthetic, or 
semi-synthetic in origin).
    As discussed above, FRA will keep all non-controlled substance 
post-accident test results confidential. FRA is therefore amending the 
first sentence of paragraph (b) as proposed in the NPRM. This change is 
intended to make clear that FRA will report post-accident test results 
for controlled substances only.
    Although not discussed in the NPRM, FRA is also amending the first 
sentence of paragraph (f)(1) of this section to state that post-
accident test results for non-controlled substances will not be in the 
final toxicology report included in each FRA accident investigation 
report. In the NPRM, FRA asked for comment on whether non-controlled 
substance results should be reported to employers and employees; most 
commentators favored keeping these post-accident test results 
confidential. While FRA did not raise the issue of whether non-
controlled substance post-accident test results should be included in 
FRA accident investigation reports, keeping these results confidential 
from employers and employees would be meaningless if FRA published them 
in its official reports. FRA will therefore redact non-controlled 
substance test results from a post-accident toxicology testing report 
before that report is published as part of an FRA accident 
investigation report. This amendment is necessary to ensure the 
complete confidentiality of non-controlled substance post-accident test 
results.

Appendix B

    As announced in the NPRM, FRA is revising Appendix B to this part 
to designate Quest Diagnostics in Tucker, Georgia as its post-accident 
testing laboratory.

Regulatory Impact and Notices

A. Executive Order 12866 and 13563 and DOT Regulatory Policies and 
Procedures

    This final rule has been evaluated in accordance with existing 
policies and procedures under both Executive Order 12866 and 13563 and 
DOT policies and procedures. See 44 FR 11034; February 26, 1979. FRA 
has prepared and placed in the docket (FRA-2010-0155) a regulatory 
impact analysis addressing the economic impact of this final rule.
    As part of the regulatory impact analysis, FRA has assessed 
pertinent costs expected from the implementation of this rulemaking. 
FRA has not found any costs associated with this final rule. Additional 
costs are assumed by the Federal government in their entirety. 
Railroads will not be required to change their collection process and 
will have to follow the same collection, shipping, and handling 
processes they currently follow. This means that individuals subject to 
post-accident testing will provide the same specimens currently 
required, which will then be tested for tramadol and sedating 
antihistamines at FRA's expense. Since FRA will use these results for 
research and accident investigation purposes only, tramadol and 
sedating antihistamines test results will not be reported directly to 
either the employee or the employing railroad. This reporting process 
will apply to both surviving and fatally injured employees. No monetary 
costs will be imposed on the industry as a result of this addition.
    As part of the regulatory impact analysis, FRA has explained what 
the likely benefits for this final rule will be, and provided numerical 
assessments of the potential value of such benefits. The inclusion of 
tramadol and sedating antihistamines will generate safety benefits. 
Qualitative benefits will be generated with the inclusion of sedating 
antihistamines and tramadol in the post-accident testing panel by 
providing FRA with the data necessary to carry out research to inform 
future policy on this topic. The final rule will generate quantifiable 
benefits upon the addition of sedating antihistamines to the post-
accident testing panel by creating a small deterring effect on the use 
of sedating antihistamines by railroad workers and encouraging the use 
of alternative medications for allergic relief. A deterring effect will 
be generated by the regulatory signal FRA is sending to the regulated 
community about the safety concern related to these non-controlled 
substances. FRA expects some individuals to alter their usage of these 
substances and improve safety.

[[Page 14222]]

Thus, in general, the final rule will reduce railroad accidents and 
their associated casualties and damages. FRA believes the value of the 
anticipated safety benefits will exceed the cost of implementing the 
final rule. Over a 10-year period, this analysis finds that $2.3 
million in benefits will accrue through accident prevention. The 
discounted value of this is $1.9 million (PV, 7 percent). The table 
below presents the estimated benefits associated with the final rule.

              10-Year Estimated Benefits of the Final Rule
                              [In millions]
------------------------------------------------------------------------
                                                      Benefits   PV, 7%
------------------------------------------------------------------------
Tramadol............................................        $0        $0
Sedating Antihistamines.............................       2.3       1.9
                                                     -------------------
    Total...........................................       2.3       1.9
------------------------------------------------------------------------
Dollars are discounted at a Present value rate of 7 percent.

Regulatory Flexibility Act--Certification of No Significant Economic 
Impact on a Substantial Number of Small Entities
    FRA developed the final rule in accordance with Executive Order 
13272 (``Proper Consideration of Small Entities in Agency Rulemaking'') 
and DOT's procedures and policies to promote compliance with the 
Regulatory Flexibility Act (5 U.S.C. 601 et seq.) to ensure potential 
impacts of rules on small entities are properly considered. FRA 
certified pursuant to the Regulatory Flexibility Act (5 U.S.C. 605(b)) 
in the NPRM. Furthermore, FRA invited all interested parties to submit 
data and information regarding this certification and did not receive 
any comments about it during the public comment period.
    The Regulatory Flexibility Act requires an agency to review 
regulations to assess their impact on small entities. An agency must 
conduct a regulatory flexibility analysis unless it determines and 
certifies that a rule is not expected to have a significant economic 
impact on a substantial number of small entities.
    Consistent with societal trends, FRA is concerned about the 
increasing use of non-controlled drugs in the railroads labor force. 
With this final rule FRA will learn about the impact of some of these 
non-controlled substances on railroad safety by updating the definition 
of non-controlled substances, changing the reporting requirements 
related to the drug panel change, and including more drugs in the 
current post-accident testing panel. This Regulatory Flexibility Impact 
Analysis is presented to comply with Executive Order 13272 and with the 
Regulatory Flexibility Act as part of the formal rulemaking process 
required by law.
    The final regulation is amending Sec. Sec.  219.5 and 219.211 by 
providing for the routine post-accident testing for non-controlled 
substances. FRA will treat post-accident test results for non-
controlled substances as confidential and will not disclose such 
results to the relevant railroad or employee.

I. Description of Regulated Entities and Impacts

    The ``universe'' of the entities under consideration includes only 
those small entities that can reasonably be expected to be directly 
affected by the provisions of this final rule. For this final rule 
there is only one type of small entity that is affected: small 
railroads.
    ``Small entity'' is defined in 5 U.S.C. 601. Section 601(3) defines 
a ``small entity'' as having the same meaning as ``small business 
concern'' under Sec.  3 of the Small Business Act. This includes any 
small business concern that is independently owned and operated, and is 
not dominant in its field of operation. Section 601(4) likewise 
includes within the definition of ``small entities'' not-for-profit 
enterprises that are independently owned and operated, and are not 
dominant in their field of operations. Additionally, 5 U.S.C. 601(5) 
defines ``small entities'' as governments of cities, counties, towns, 
townships, villages, school districts, or special districts with 
populations less than 50,000.
    The U.S. Small Business Administration (SBA) stipulates ``size 
standards'' for small entities. It provides that the largest a for-
profit railroad business firm may be (and still classify as a ``small 
entity'') is 1,500 employees for ``Line-Haul Operating'' railroads, and 
500 employees for ``Short-Line Operating'' railroads.\1\
---------------------------------------------------------------------------

    \1\ ``Table of Size Standards,'' U.S. Small Business 
Administration, January 31, 1996, 13 CFR Part 121.
---------------------------------------------------------------------------

    Federal agencies may adopt their own size standards for small 
entities in consultation with SBA, and in conjunction with public 
comment. Pursuant to the authority provided to it by SBA, FRA has 
published a final policy, which formally establishes small entities as 
railroads that meet the line haulage revenue requirements of a Class 
III railroad.\2\ Currently, the revenue requirements are $20 million or 
less in annual operating revenue, adjusted annually for inflation. The 
$20 million limit (adjusted annually for inflation) is based on the 
Surface Transportation Board's threshold of a Class III railroad, which 
is adjusted by applying the railroad revenue deflator adjustment.\3\ 
FRA is using this definition for this final rule.
---------------------------------------------------------------------------

    \2\ See 68 FR 24891 (May 9, 2003).
    \3\ For further information on the calculation of the specific 
dollar limit, please see 49 CFR Part 1201.
---------------------------------------------------------------------------

Railroads
    FRA regulates a total 756 railroads. However, only 644 could be 
considered to be small for the purposes of this analysis because 7 are 
large Class I freight railroads, Amtrak and 26 commuter railroads 
serving communities larger than 50,000 people, and 12 are Class II 
railroads. All these railroads are not considered to be small. The rest 
of the railroads not included in this analysis do not operate in the 
general railroad system and are not subject to the final regulation. 
Two commuter railroads were included in this analysis, the Hawkeye 
Express and the Saratoga & North Creek Railway. The Hawkeye Express 
provides commuter service to Iowa City and is owned by a Class III 
railroad, a small entity. The Saratoga & North Creek Railway started 
operations in 2011, serving several stations between North Creek and 
Saratoga Springs, New York with three trains a day and meets the 
criteria to be considered a small entity.

----------------------------------------------------------------------------------------------------------------
                                                                                  Railroads that
                                                                                  do not operate
                        Type of railroad                               Total        in general         Small
                                                                                      system
----------------------------------------------------------------------------------------------------------------
Freight Class I.................................................               7               0               0
Freight Class II................................................              12               0               0
Freight Class III...............................................             708              66             642
Amtrak..........................................................               1               0               0

[[Page 14223]]

 
Commuter........................................................              28               0               2
                                                                 -----------------------------------------------
    Total.......................................................             756              66             644
----------------------------------------------------------------------------------------------------------------

    It is important to note that the small entities being considered in 
this analysis are knowledgeable about current post-accident testing 
requirements. Most small railroads have experience on carrying out a 
post-accident test. Data from the FRA's Drug and Alcohol Program 
reveals that generally, about 4 or 5 percent of all post-accident 
testing qualifying events involve a small railroad. For example, in 
2011 with a total of 87 post-accident testing events, four implicated 
Class III railroads. Similarly, in 2010, 85 post-accident testing 
events involved four Class III railroads.
    This final rule does not increase costs for small railroads. The 
cost for testing additional drugs will be paid by the FRA through 
existing contracts. Railroads will follow the same collection and 
shipping process for urine and blood samples that is currently in 
place. Results originating from this regulatory change will only be 
used by FRA for research and investigation purposes only and will not 
be shared with external entities. Therefore, in the eventuality that an 
employee from a small railroad is found positive on any of these non-
controlled substances neither the railroad nor the employee will face 
additional expenses to respond to that finding.
Significant Economic Impact Criteria
    Previously, FRA sampled small railroads and found that revenue 
averaged approximately $4.7 million (not discounted) in 2006. One 
percent of that average annual revenue per small railroad is $47,000. 
FRA realizes that some railroads will have a lower revenue than $4.7 
million. However, FRA estimates that small railroads will not have any 
additional expenses over the next ten years to comply with the new 
requirements in this final regulation. Based on this, FRA concludes 
that the expected burden of this final rule will not have a significant 
impact on the competitive position of small entities, or on the small 
entity segment of the railroad industry as a whole.
Substantial Number Criteria
    This final rule will likely burden all small railroads that are not 
exempt from its scope or application (See 49 CFR 219.3). Thus, as noted 
above this final rule will impact a substantial number of small 
railroads.

II. Certification

    Pursuant to the Regulatory Flexibility Act (5 U.S.C. 605(b)), FRA 
certifies that this final rule will not have a significant economic 
impact on a substantial number of small entities. FRA invited all 
interested parties to submit data and information regarding the 
potential economic impact that will result from adoption of the 
proposals in the NPRM. FRA did not receive any comments concerning this 
certification in the public comment process.

Paperwork Reduction Act

    The information collection requirements in this rule are being 
submitted for approval to the Office of Management and Budget (OMB) 
under the Paperwork Reduction Act of 1995, 44 U.S.C. 3501 et seq. The 
section that contains the revised information collection requirement 
and the estimated time to fulfill that requirement is as follows:

----------------------------------------------------------------------------------------------------------------
                                        Respondent         Total  annual       Average time per    Total annual
           CFR Section                   universe            responses             response        burden hours
----------------------------------------------------------------------------------------------------------------
219.211--Analysis and Follow-up--  698 railroads......  16 reports + 16      15 minutes + 5                    5
 Reports of Positive Post-                               report copies.       minutes.
 Accident Toxicological Test
 (Controlled Substances) to
 Medical Review Officer and
 Employee (Revised Requirement).
----------------------------------------------------------------------------------------------------------------

    All estimates include the time for reviewing instructions; 
searching existing data sources; gathering or maintaining the needed 
data; and reviewing the information. Pursuant to 44 U.S.C. 
3506(c)(2)(B), FRA solicits comments concerning: whether these 
information collection requirements are necessary for the proper 
performance of the functions of FRA, including whether the information 
has practical utility; the accuracy of FRA's estimates of the burden of 
the information collection requirements; the quality, utility, and 
clarity of the information to be collected; and whether the burden of 
collection of information on those who are to respond, including 
through the use of automated collection techniques or other forms of 
information technology, may be minimized. For information or a copy of 
the paperwork package submitted to OMB, contact Mr. Robert Brogan, 
Information Clearance Officer, at 202-493-6292, or Ms. Kimberly Toone 
at 202-493-6132.
    Organizations and individuals desiring to submit comments on the 
collection of information requirements should direct them to Mr. Robert 
Brogan or Ms. Kimberly Toone, Federal Railroad Administration, 1200 New 
Jersey Avenue SE., 3rd Floor, Washington, DC 20590. Comments may also 
be submitted via email to Mr. Brogan or Ms. Toone at the following 
address: Robert.Brogan@dot.gov; Kim.Toone@dot.gov.
    OMB is required to make a decision concerning the collection of 
information requirements contained in this rule between 30 and 60 days 
after publication of this document in the Federal Register. Therefore, 
a comment to OMB is best assured of having its full effect if OMB 
receives it within 30 days of publication.
    FRA is not authorized to impose a penalty on persons for violating 
information collection requirements which do not display a current OMB 
control number, if required. FRA intends to obtain current OMB control 
numbers for any new information collection requirements resulting from 
this rulemaking action prior to the effective date of the final rule. 
The OMB control number, when assigned, will be announced by separate 
notice in the Federal Register.

[[Page 14224]]

Federalism Implications

    Executive Order 13132, ``Federalism'' (64 FR 43255, Aug. 4, 1999), 
requires FRA to develop an accountable process to ensure ``meaningful 
and timely input by State and local officials in the development of 
regulatory policies that have federalism implications.'' ``Policies 
that have federalism implications'' are defined in the Executive Order 
to include regulations that have ``substantial direct effects on the 
States, on the relationship between the national government and the 
States, or on the distribution of power and responsibilities among the 
various levels of government.'' Under Executive Order 13132, the agency 
may not issue a regulation with federalism implications that imposes 
substantial direct compliance costs and that is not required by 
statute, unless the Federal government provides the funds necessary to 
pay the direct compliance costs incurred by State and local 
governments, or the agency consults with State and local government 
officials early in the process of developing the regulation. Where a 
regulation has federalism implications and preempts State law, the 
agency seeks to consult with State and local officials in the process 
of developing the regulation. FRA has analyzed this final rule in 
accordance with the principles and criteria contained in Executive 
Order 13132. FRA believes this final rule it is in compliance with 
Executive Order 13132.
    This final rule will not have a substantial effect on the States, 
on the relationship between the Federal government and the States, or 
on the distribution of power and responsibilities among the various 
levels of government. In addition, this final rule will not have any 
federalism implications that impose substantial direct compliance costs 
on State and local governments.
    This final will have preemptive effect by operation of law under 
certain provisions of the Federal railroad safety statutes, 
specifically the former Federal Rail Safety Act (FRSA), repealed and 
recodified at 49 U.S.C 20106. The former FRSA provides that States may 
not adopt or continue in effect any law, regulation, or order related 
to railroad safety or security that covers the subject matter of a 
regulation prescribed or order issued by the Secretary of 
Transportation (with respect to railroad safety matters) or the 
Secretary of Homeland Security (with respect to railroad security 
matters), except when the State law, regulation, or order qualifies 
under the ``local safety or security hazard'' exception to section 
20106.

Environmental Impact

    FRA has evaluated this final rule in accordance with its 
``Procedures for Considering Environmental Impacts'' (``FRA's 
Procedures'') (64 FR 28545, May 26, 1999) as required by the National 
Environmental Policy Act (42 U.S.C. 4321 et seq.), other environmental 
statutes, Executive Orders, and related regulatory requirements. FRA 
has determined that this final rule is not a major FRA action 
(requiring the preparation of an environmental impact statement or 
environmental assessment) because it is categorically excluded from 
detailed environmental review pursuant to section 4(c)(20) of FRA's 
Procedures. In accordance with section 4(c) and (e) of FRA's 
Procedures, the agency has further concluded that no extraordinary 
circumstances exist with respect to this regulation that might trigger 
the need for a more detailed environmental review. As a result, FRA 
finds that this final rule is not a major Federal action significantly 
affecting the quality of the human environment.

Unfunded Mandates Reform Act of 1995

    The Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4, 2 U.S.C. 
1531) requires agencies to prepare a written assessment of the costs, 
benefits, and other effects of proposed or final rules that include a 
Federal mandate likely to result in the expenditures by State, local or 
tribal governments, in the aggregate, or by the private sector, of more 
than $100 million annually (adjusted annually for inflation with base 
year of 1995). The value equivalent of $100 million in CY 1950, 
adjusted annually for inflation to CY 2008 levels by the Consumer Price 
Index for All Urban Consumers (CPI-U) is $141.3 million. This 
assessment may be included in conjunction with other assessments, as it 
is here. This final rule will not create an unfunded mandate in excess 
of the threshold amount.

Energy Impact

    Executive Order 13211 requires Federal agencies to prepare a 
Statement of Energy Effects for any ``significant energy action.'' 66 
FR 28355 (May 22, 2001). Under the Executive Order, a ``significant 
energy action'' is defined as any action by an agency (normally 
published in the Federal Register) that promulgates or is expected to 
lead to the promulgation of a final rule or regulation, including 
notices of inquiry, advance notices of proposed rulemaking, and notices 
of proposed rulemaking: (1)(i) That is a significant regulatory action 
under Executive Order 12866 or any successor order, and (ii) is likely 
to have a significant adverse effect on the supply, distribution, or 
use of energy; or (2) that is designated by the Administrator of the 
Office of Information and Regulatory Affairs as a significant energy 
action. FRA has evaluated this final rule in accordance with Executive 
Order 13211, and determined that it is not a ``significant regulatory 
action'' likely to have a significant adverse effect on the supply, 
distribution, or use of energy.

Privacy Act

    Anyone is able to search the electronic form of any comments or 
other written communications received into any of FRA's dockets, by the 
name of the individual submitting the comment or other written 
communication (or signing the comment or other written communication, 
if submitted on behalf of an association, business, labor union, etc.). 
See http://www.regulations.gov/#!privacyNotice for the privacy notice 
of regulations.gov, or you may review DOT's complete Privacy Act 
Statement in the Federal Register published on April 11, 2000 (65 FR 
19477).

List of Subjects in 49 CFR Part 219

    Alcohol abuse, Drug abuse, Drug testing, Penalties, Railroad 
safety, Reporting and recordkeeping requirements, Safety, 
Transportation.

The Rule

    For the reasons stated above, FRA amends part 219 of chapter II, 
subtitle B of title 49, Code of Federal Regulations, as follows:

PART 219--[AMENDED]

0
1. The authority citation for part 219 is revised to read as follows:

    Authority: 49 U.S.C. 20102-20103, 20107, 20140, 21301, 21304, 
21311; 28 U.S.C. 2461, note; and 49 CFR 1.89.


0
2. Amend Sec.  219.5 by adding a definition of Non-controlled substance 
to read as follows:


Sec.  219.5  Definitions.

* * * * *
    Non-controlled substance means any substance (including 
prescription medications, over-the-counter products, dietary 
supplements, and herbal preparations) which is not currently regulated 
under 21 U.S.C. 801-971 or 21 CFR part 1308.
* * * * *

[[Page 14225]]

Sec.  219.13  [Removed and Reserved]

0
3. Remove and reserve Sec.  219.13.

0
4. Revise Sec.  219.17 to read as follows:


Sec.  219.17  Construction.

    Nothing in this part--
    (a) Restricts the power of FRA to conduct investigations under 
sections 20107, 20108, 20111, and 20112 of title 49, United States 
Code;
    (b) Creates a private right of action on the part of any person for 
enforcement of the provisions of this part or for damages resulting 
from noncompliance with this part; or
    (c) Impacts provisions of State criminal law that impose sanctions 
for reckless conduct that leads to actual loss of life, injury or 
damage to property, whether such provisions apply specifically to 
railroad employees or generally to the public at large.

0
5. Amend Sec.  219.211 by revising paragraph (a), the first sentence of 
paragraph (b), and paragraph (f)(2) to read as follows:


Sec.  219.211  Analysis and follow-up.

    (a) The laboratory designated in appendix B to this part undertakes 
prompt analysis of provided under this subpart, consistent with the 
need to develop all relevant information and produce a complete report. 
Specimens are analyzed for alcohol, controlled substances, and non-
controlled substances specified by FRA under protocols specified by 
FRA. These substances may be tested for in any form, whether naturally 
or synthetically derived. Specimens may be analyzed for other impairing 
substances specified by FRA as necessary to the particular accident 
investigation.
    (b) Results of post-accident toxicological testing for controlled 
substances conducted under this subpart are reported to the railroad's 
Medical Review Officer and the employee. * * *
* * * * *
    (f) * * *
    (2) With the exception of post-accident test results for non-
controlled substances, the toxicology report is a part of the report of 
the accident/incident and therefore subject to the limitation of 49 
U.S.C. 20903 (prohibiting use of the report for any purpose in a civil 
action for damages resulting from a matter mentioned in the report).
* * * * *

0
6. Revise Appendix B to part 219 to read as follows:

Appendix B to Part 219--Designation of Laboratory for Post-Accident 
Toxicological Testing

    The following laboratory is currently designated to conduct 
post-accident toxicological analysis under subpart C of this part: 
Quest Diagnostics, 1777 Montreal Circle, Tucker, GA 30084, 
Telephone: (800) 729-6432.

     Issued in Washington, DC, on February 26, 2013.
Joseph C. Szabo,
Administrator.
[FR Doc. 2013-05010 Filed 3-4-13; 8:45 am]
BILLING CODE 4910-06-P