
[Federal Register Volume 77, Number 96 (Thursday, May 17, 2012)]
[Proposed Rules]
[Pages 29307-29312]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-11969]


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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: Notice of proposed rulemaking (NPRM).

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SUMMARY: Since 1985, FRA has conducted post-accident toxicological 
testing (post-accident testing) on blood, urine, and, if an employee is 
deceased, tissue samples from railroad employees involved in serious 
train accidents. If an accident qualifies for post-accident testing, 
FRA routinely conducts tests for alcohol, marijuana, cocaine, 
phencyclidine (PCP), and certain amphetamines, opiates, barbiturates, 
and benzodiazepines. FRA is proposing to add certain potentially 
impairing non-controlled substances to its standard post-accident 
testing panel because FRA's research indicates that use of prescription 
and over-the-counter (OTC) drugs, most of which are non-controlled 
substances, is prevalent among railroad employees.

DATES: Submit comments on or before July 16, 2012.

ADDRESSES: Comments: Comments 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. Note that all comments received will be posted without 
change to http://www.regulations.gov including 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 comments or materials.

FOR FURTHER INFORMATION CONTACT: For program and technical issues, 
contact Lamar Allen, Alcohol and Drug Program Manager, Office of Safety 
Enforcement, Mail Stop 25, FRA, 1200 New Jersey Avenue SE., Washington, 
DC 20590 (telephone 202-493-6313), lamar.allen@dot.gov. For legal 
issues, 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: 

Background

    Since 1985, as part of its accident investigation program, FRA has 
conducted post-accident alcohol and drug tests on railroad employees 
who have been involved in serious train accidents (50 FR 31508, August 
2, 1985). If an accident meets FRA's criteria for post-accident testing 
(see 49 CFR 219.201), FRA conducts tests for alcohol and for certain 
drugs classified as controlled substances under 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.). 
Controlled substances are drugs or chemicals that are prohibited or 
strictly regulated because of their potential for abuse or addiction. 
The Drug Enforcement Administration (DEA), which is primarily 
responsible for enforcing the CSA, oversees the classification of 
controlled substances into five schedules. Schedule I contains illicit 
drugs, such as marijuana and heroin, which have no legitimate medical 
use under Federal law. Schedules II-V contain legal drugs which are 
available only by prescription because of their potential for abuse. 
Currently, FRA routinely conducts post-accident tests for the following 
drugs: marijuana, cocaine, phencyclidine (PCP), and certain opiates, 
amphetamines, barbiturates, and benzodiazepines.
    As detailed below, FRA research indicates that prescription and OTC 
drug use has become prevalent among railroad employees. For this reason 
FRA is proposing to add certain non-controlled substances to its 
standard post-accident testing program, which currently routinely tests 
only for alcohol and controlled substances. At this time, FRA intends 
to add two types of non-controlled substances, tramadol (a synthetic 
opioid) and sedating antihistamines. Publication of this NPRM, however, 
in no way limits FRA's post-accident testing to the identified 
substances or in any way restricts FRA's ability to make routine 
amendments to its standard post-accident testing panel without prior 
notice. Furthermore, in addition to its standard post-accident testing 
panel, FRA always has the ability to test for ``other impairing 
substances specified by FRA as necessary to the particular accident 
investigation.'' See 49 CFR 219.211(a). This flexibility is essential, 
since it allows FRA to conduct post-accident tests for any substance 
(e.g., carbon

[[Page 29308]]

monoxide) that its preliminary investigation shows may have played a 
role in an accident.
    FRA is proposing to add tests for certain non-controlled substances 
to respond to the significant rise in prescription and OTC drug use in 
the more than 25 years since FRA began post-accident testing. In 2006, 
an ongoing telephone survey about the use of medications by U.S. adults 
found that 82 percent took at least one prescription or OTC drug, 
dietary supplement, or herbal remedy, each week. See Slone Epidemiology 
Center at Boston University, Patterns of Medications Use in the United 
States (2006). Also in 2006, a study commissioned by the National 
Community Pharmacists Association (NCPA) found that up to 75 percent of 
Americans reported not always taking their prescription medication as 
directed, 49 percent reported forgetting to take a prescribed 
medication, 31 percent reported not filling a prescription, 29 percent 
reported stopping use of a medication before its supply ran out, and 24 
percent reported taking less than the recommended dosage. See National 
Community Pharmacists Association, Take as Directed: A Prescription Not 
Followed (2006). Today, the Physician's Desk Reference contains over 
13,000 prescription drugs, most of which are non-controlled substances.
    In 1998, FRA first expressed concerns that Sec.  219.103, which 
addresses the use of Schedule II-V controlled substances by safety-
sensitive employees, may be too narrow to cover the use of prescription 
and OTC drugs since most of these drugs are not controlled substances. 
To supplement Sec.  219.103, FRA issued Safety Advisory 98-3 
(Advisory), Recommended practices for the safe use of prescription and 
over-the-counter drugs by safety-sensitive railroad employees, which 
made recommendations to railroads on how to handle prescription and OTC 
drug use by their safety-sensitive employees. See 63 FR 71334, December 
24, 1998.
    After issuing this Advisory, FRA initiated two projects to research 
whether the prevalence of prescription drugs should be more closely 
evaluated and monitored as a possible safety concern in the rail 
industry. As detailed below, both projects found that prescription and 
OTC drug use was prevalent among railroad employees involved in 
reportable accidents.
    In the first project, which lasted from April 2002 to April 2009, 
FRA asked railroad employees who had been involved in human-factor 
accidents that were reportable under FRA's accident reporting 
regulations at 49 CFR part 225 to complete FRA surveys on their recent 
prescription and OTC drug use. Of the 294 human-factor accidents 
surveyed, only 20 percent had no employee self-reports of drug use 
(this 20 percent also included accidents where employees would not 
complete questionnaires or could not be located). In the 80 percent of 
surveyed accidents where prescription or OTC drug use, or both, had 
been self-reported, employees listed a wide variety of generic and 
brand name drugs, with many employees listing multiple prescription and 
OTC drugs, as well as dietary supplements and herbal preparations.
    In 2005, FRA began a second research project that partially 
responded to one in a series of recommendations to FRA made by the 
National Transportation Safety Board (NTSB) concerning the use of 
prescription and OTC drugs by safety-sensitive employees. (The NTSB 
made similar recommendations to DOT and other DOT agencies.)

    R-00-004: Establish in coordination with the U.S. Department of 
Transportation, the Federal Motor Carrier Safety Administration, the 
Federal Transit Administration, and the U.S. Coast Guard, 
comprehensive toxicological testing requirements for an appropriate 
sample of fatal highway, railroad, transit, and marine accidents to 
ensure the identification of the role played by common prescription 
and over-the-counter medications. Review and analyze the results of 
such testing at intervals not to exceed 5 years.

In this project, FRA re-tested a sample of 150 frozen post-accident 
testing urine specimens that had previously been reported as negative 
for the substances in the agency's standard post-accident drug testing 
panel. After redacting any identifying employee information, FRA used a 
commercially available medical professional drug testing panel to re-
test these specimens for commonly used prescription and OTC drugs with 
known risks of adverse side effects, such as pain relievers, anti-
depressants, and sedating antihistamines. Of the 150 re-tested samples, 
14 (9.3 percent) tested positive for at least one potentially impairing 
prescription or OTC drug. These post-accident re-testing results 
confirmed those of FRA's human-factor accident survey, by also showing 
that prescription and OTC drug use was prevalent among railroad 
employees.

Proposed Addition of Tests for Non-Controlled Substances

    Because FRA's post-accident testing program predates both DOT's 
testing procedures (49 CFR part 40) and the Omnibus Transportation 
Employee Testing Act of 1991, neither part 40 nor Department of Health 
and Human Services (HHS) guidelines apply to post-accident testing 
procedures and protocols. See 49 CFR 40.1. All post-accident tests are 
conducted on behalf of FRA by a single laboratory (FRA is revising 
appendix B to 49 CFR Part 219 to designate Quest Diagnostics as its 
post-accident testing laboratory) in accordance with FRA 
specifications. FRA conducts compliance and quality audits of the 
laboratory each quarter.
    As explained above, FRA intends to add testing for two types of 
non-controlled substances (tramadol (a synthetic opioid) and sedating 
antihistamines) to its standard post-accident testing program to 
address the widespread use of prescription and OTC drugs by railroad 
employees. Both tramadol and the drugs in the sedating antihistamine 
category have potential side effects that could impair an employee's 
cognitive abilities (such as the ability to stay awake and alert or the 
ability to recognize and take appropriate emergency action) or cause 
impairing conditions (such as dizziness, agitation, and loss of 
coordination). These drugs are discussed below:
     Tramadol. Tramadol is a semi-synthetic opioid. Opioids can 
be natural (e.g., codeine and morphine), semi-synthetic (e.g., 
oxycodone and hydromorphone), or wholly synthetic in origin (e.g., 
methadone). All opioids, regardless of origin, pose risks of sedation, 
and can cause abuse and dependence with prolonged use.
     Sedating antihistamines. This widely used category of 
drugs includes, but is not limited to, diphenhydramine, 
chlorpheniramine, brompheniramine, and doxylamine. Sedating 
antihistamines are used primarily to treat allergy and cold symptoms, 
but may also be used as sleep aids or as treatment for allergic 
reactions such as itching and swelling. As their name implies, sedating 
antihistamines (as opposed to non-sedating antihistamines such as 
loratadine) have a known tendency to cause drowsiness. Because of this 
tendency, the manufacturer's instructions on the packaging and labeling 
of sedating antihistamines caution against use while driving, operating 
machinery, or performing tasks where alertness is required. Although 
these drugs are available at both prescription and OTC dosages, 
sedating anithistamines are usually taken as OTC drugs.
    Adding testing for these types of non-controlled substances to its 
post-accident testing program will enable FRA to detect a broader range 
of potentially impairing drugs that may contribute to the cause or 
severity of accidents. As FRA has done for the

[[Page 29309]]

controlled substances in its standard post-accident panel, FRA would 
consult with forensic toxicologists to establish screening and 
confirmation limits and administrative cut-offs for these non-
controlled substances.
    Although FRA is not proposing any change in its handling of post-
accident test results for controlled substances in accordance with 49 
CFR 219.211, FRA is proposing to handle the post-accident results for 
non-controlled substances differently. Specifically, as mentioned 
earlier, while sedating antihistamines are available at both 
prescription and OTC dosages, they are usually taken as OTC drugs. 
Since by definition these drugs can cause sedation, in 2009 FRA began 
post-accident testing for sedating antihistamines to determine whether 
their use is becoming a safety issue in the rail industry. This testing 
has been for research and accident investigation purposes only, and FRA 
has not reported any sedating antihistamine test results to railroads 
or employees. FRA intends to continue its research testing related to 
sedating antihistamines and in this NPRM proposes to continue to keep 
the testing results confidential and not report to the relevant 
railroad or employee any sedating antihistamine post-accident test 
results. FRA seeks comment on this proposal (i.e., whether the agency 
should continue to keep post-accident test results for sedating 
antihistamines confidential).
    In contrast, while tramadol is also a non-controlled substance, it 
is a prescription-only semi-synthetic opioid that can cause drowsiness 
and dizziness. FRA is seeking specific comments on how it should handle 
tramadol post-accident test results. Should FRA release post-accident 
test results for tramadol as it does for other opioids that are 
controlled substances? Should FRA keep post-accident results for 
tramadol confidential as it proposes to continue doing for sedating 
antihistamines? Is there another approach that would better handle 
tramadol test results?
    The proposed addition of these non-controlled substances to FRA's 
standard post-accident program would not create new direct costs for 
employers since FRA would bear the costs of the additional post-
accident tests. Any additional costs to employers would be minimal and 
indirect, such as the cost of responding to an increased number of 
positive post-accident test results should FRA decide to report 
tramadol or sedating antihistamine results, or both.

Contents of Standard Post-Accident Testing Box

    As mentioned above, FRA's post-accident testing program has been in 
existence since 1985. FRA has received suggestions from railroad 
representatives, collectors, and others on how to make the program's 
requirements easier to understand and follow. Although not directly 
related to the regulatory proposals in this NPRM, FRA is incorporating 
some of these suggestions into its post-accident testing program. For 
example, FRA is amending the contents of its standard post-accident 
testing box, which contains instructions, forms and supplies for the 
collection of urine and blood samples from three surviving employees. 
(FRA is not changing the contents of its fatalities post-accident 
testing box.) FRA is updating Form FRA F 6180.74, Post-Accident Testing 
Blood/Urine Custody and Control Form (Form 74) by deleting outdated 
information requests (e.g., removing the space for identification of 
the employee's home terminal in Step 1), streamlining the chain of 
custody documentation in Step 5, and making other miscellaneous 
amendments. (FRA is not changing Form FRA F 6180.73, Accident 
Information Required for Post-Accident Toxicological Testing.) FRA will 
also add new guidance documents to the contents of its standard post-
accident testing box to familiarize individuals who may become involved 
in the collection of post-accident samples but who do not regularly 
work with the rail industry (e.g., employees of independent medical 
facilities and local law enforcement officers) with the post-accident 
testing program's basis, purpose, and requirements.

Section-by-Section Analysis

Section 219.5--Definitions

    As mentioned above, in FRA's survey of employees involved in 
reportable human factor accidents, many employees self-reported using 
multiple substances; most of these, whether prescription drugs, OTC 
drugs, dietary supplements, or herbal preparations, were non-controlled 
substances. Part 219 already defines a controlled substance, but FRA 
believes that a definition of a non-controlled substance is necessary 
now to help employees better understand the variety of substances 
available. FRA would define a non-controlled substance as any substance 
that the DEA has not classified as a controlled substance under the 
CSA.

Section 219.13--Preemptive Effect

    FRA is proposing to remove this section from part 219. FRA believes 
that the preemption language in paragraph (a) of this section is 
unnecessary because 49 U.S.C. 20106 does not require additional Federal 
regulatory provisions concerning a regulation's preemptive effect. As 
stated in the Federalism Implications statement of this NPRM, part 219 
could have preemptive effect by operation of law under the Federal Rail 
Safety Act (FRSA). See 49 U.S.C. 20106.
    As discussed below, however, FRA is proposing to add language 
similar to that currently found in paragraph (b) of this section to a 
new paragraph (c) in Sec.  219.17, clarifying the lack of impact that 
part 219 has on State criminal law. FRA is keeping this language in 
part 219 because it is instructive and consistent with long-standing 
FRA guidance.

Section 219.17--Construction

    FRA is proposing to add a new paragraph (c) to this section that 
would contain language similar to that currently found in Sec.  
219.13(b). This language would state 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. As noted above, similar language is currently found in Sec.  
219.13(b) and FRA is not proposing any substantive change with this 
amendment.

Section 219.211--Analysis and Follow-Up

    In the second sentence of paragraph (a), FRA proposes to replace 
the phrase ``alcohol and controlled substances specified by FRA'' with 
``alcohol, controlled substances, and non-controlled substances 
specified by FRA'' to add routine testing for non-controlled substances 
to its post-accident testing program. From this same sentence, FRA also 
proposes to delete the reference to submittal of FRA post-accident 
testing protocols to HHS. As stated earlier, FRA's post-accident 
testing program is exempted from HHS guidelines. Finally, FRA would add 
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.)
    FRA also proposes to amend the first sentence of paragraph (b) in 
this section to limit reporting of post-accident test results to 
results for controlled

[[Page 29310]]

substances only. As mentioned above, FRA is asking for comments on how 
to handle the reporting of post-accident test results of non-controlled 
substances (tramadol and sedating antihistamines). FRA may make 
additional amendments to this paragraph after it has considered any 
comments received.

Regulatory Impact and Notices

Executive Order 12866 and 13563 and DOT Regulatory Policies and 
Procedures

    This proposed 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 proposed rule.
    As part of the regulatory impact analysis, FRA has assessed 
pertinent costs expected from the implementation of this proposed rule. 
FRA has not found any costs associated with this NPRM for the regulated 
industry. Any associated costs for conducting post-accident testing for 
non-controlled substances would be nominal and assumed by the Federal 
government in their entirety. Railroads would not be required to change 
their collection process and would have to follow the same collection, 
shipping, and handling processes they currently follow. This means that 
individuals subject to post-accident testing would provide the same 
specimens currently required, which would then be tested for tramadol 
and sedating antihistamines at FRA's expense. Since FRA would use these 
results for research and accident investigation purposes only, tramadol 
and sedating antihistamines test results would not be reported directly 
to either the employee or the employing railroad. This reporting 
process would apply to both surviving and fatally injured employees. No 
monetary costs would 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 proposed rule would be, and provided 
numerical assessments of the potential value of such benefits. The 
proposed inclusion of tramadol and sedating antihistamines would 
generate safety benefits. Qualitative benefits would 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 NPRM 
would 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. Thus, in general, the proposed rule should reduce railroad 
accidents and their associated casualties and damages. FRA believes the 
value of the anticipated safety benefits would exceed the cost to the 
industry of implementing the proposed rule. Over a 10-year period, this 
analysis finds that $2.3 million in benefits would 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 proposed rule.

               10-Year Estimated Benefits of Proposed 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 and Executive Order 13272

    The Regulatory Flexibility Act (5 U.S.C. 601 et seq.) and Executive 
Order 13272 require a review of proposed and final rules to assess 
their impacts on small entities. An agency must prepare an initial 
regulatory flexibility analysis (IRFA) unless it determines and 
certifies that a rule, if promulgated, would not have a significant 
impact on a substantial number of small entities. FRA certifies that 
this proposed rule would not have a significant impact on a substantial 
number of small entities.

Paperwork Reduction Act

    The revised information collection requirements in this proposed 
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 this requirement are as 
follows:

----------------------------------------------------------------------------------------------------------------
                                                            Total annual       Average time per    Total annual
           CFR Section             Respondent 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 this 
information collection requirement is 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 requirement; 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

[[Page 29311]]

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 requirement 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; Kimberly.Toone@dot.gov.
    OMB is required to make a decision concerning the collection of 
information requirement contained in this proposed 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. The final rule will 
respond to any OMB or public comments on the information collection 
requirements contained in this proposal.
    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 requirement 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.

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 NPRM in accordance 
with the principles and criteria contained in Executive Order 13132. 
This NPRM complies with a statutory mandate, and FRA believes it is in 
compliance with Executive Order 13132.
    This NPRM 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 NPRM will not have any federalism 
implications that impose substantial direct compliance costs on State 
and local governments.
    This NPRM could have preemptive effect by operation of law under 
certain provisions of the Federal railroad safety statutes, 
specifically the former 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 proposed 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 proposed 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 proposed 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. The proposed rule would 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 proposed 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

    FRA wishes to inform all interested parties that anyone is able to 
search the electronic form of any written communications and comments 
received into any of our dockets by the name of the individual 
submitting the

[[Page 29312]]

document (or signing the document), if submitted on behalf of an 
association, business, labor union, etc.). Interested parties may also 
review DOT's complete Privacy Act Statement in the Federal Register 
published on April 11, 2000 (65 FR 19477) or visit http://www.dot.gov/privacy.html.

List of Subjects in 49 CFR Part 219

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

The Proposed Rule

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

PART 219--[AMENDED]

    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 1.49.

    2. Amend Sec.  219.5 by adding the following definition for ``Non-
controlled substance'' in alphabetical order 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.
* * * * *


Sec.  219.13  [Removed and Reserved]

    3. Remove and reserve Sec.  219.13.
    4. Amend Sec.  219.17 by adding paragraph (c) to read as follows:


Sec.  219.17  Construction.

* * * * *
    (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.
    5. Amend Sec.  219.211 by revising paragraph (a) and the first 
sentence of paragraph (b) 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 specimens 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. * * *
* * * * *
    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 May 10, 2012.
Melissa L. Porter,
Chief Counsel.
[FR Doc. 2012-11969 Filed 5-16-12; 8:45 am]
BILLING CODE 4910-06-P


