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