[Federal Register Volume 77, Number 96 (Thursday, May 17, 2012)]
[Proposed Rules]
[Pages 29307-29312]
From the Federal Register Online via the Government Publishing 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), [email protected]. 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), [email protected].
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
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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).
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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: [email protected]; [email protected].
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