[Federal Register Volume 81, Number 44 (Monday, March 7, 2016)]
[Notices]
[Pages 11811-11812]
[FR Doc No: 2016-04964]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-D-1213]

Environmental Assessment: Questions and Answers Regarding Drugs
With Estrogenic, Androgenic, or Thyroid Activity; Guidance for
Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a guidance for industry entitled ``Environmental
Assessment: Questions and Answers Regarding Drugs With Estrogenic,
Androgenic, or Thyroid Activity.'' It is intended to help sponsors of
such drugs determine whether they should submit environmental
assessments (EA) for drug applications and certain supplements, and to
clarify what information such sponsors should include if they submit a
claim of categorical exclusion instead of an EA.

DATES: Submit either electronic or written comments on Agency guidances
at any time.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to http://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on http://www.regulations.gov.
     If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of
Dockets Management, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2015-D-1213 for Environmental Assessment: Questions and Answers
Regarding Drugs with Estrogenic, Androgenic, or Thyroid Activity.
Received comments will be placed in the docket and, except for those
submitted as ``Confidential Submissions,'' publicly viewable at http://www.regulations.gov or at the Division of Dockets Management between 9
a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your

comments only as a written/paper submission. You should submit two
copies total. One copy will include the information you claim to be
confidential with a heading or cover note that states ``THIS DOCUMENT
CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will review this copy,
including the claimed confidential information, in its consideration of
comments. The second copy, which will have the claimed confidential
information redacted/blacked out, will be available for public viewing
and posted on http://www.regulations.gov. Submit both copies to the
Division of Dockets Management. If you do not wish your name and
contact information to be made publicly available, you can provide this
information on the cover sheet and not in the body of your comments and
you must identify this information as ``confidential.'' Any information
marked as ``confidential'' will not be disclosed except in accordance
with 21 CFR 10.20 and other applicable disclosure law. For more
information about FDA's posting of comments to public dockets, see 80
FR 56469, September 18, 2015, or access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Division of Dockets Management, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
    Submit written requests for single copies of this guidance to the
Division of Drug Information, Center for Drug Evaluation and Research,
Food and Drug Administration, 10001 New Hampshire Ave., Hillandale
Building, 4th Floor, Silver Spring, MD 20993-0002. Send one self-
addressed adhesive label to assist that office in processing your
requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the guidance document.

FOR FURTHER INFORMATION CONTACT: Raanan A. Bloom, Environmental
Assessment Team, Center for Drug Evaluation and Research, Food and Drug
Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002,
301-796-2185<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance for industry
entitled ``Environmental Assessment: Questions and Answers Regarding
Drugs with Estrogenic, Androgenic, or Thyroid Activity.'' This guidance
finalizes the draft of the same name that published on April 29, 2015.
The National Environmental Policy Act of 1969 (NEPA) requires all
Federal agencies to assess the environmental impact of their actions
and to ensure that the interested and affected public is informed of
the environmental analyses. FDA regulations at 21 CFR part 25 specify
that EAs must be submitted as part of certain new drug applications
(NDAs), abbreviated new drug applications (ANDAs), biologic license
applications (BLAs), supplements to such applications, and
investigational new drug applications (INDs), and for various other
actions, unless the action qualifies for a categorical exclusion.
Failure to submit either an EA or a claim of categorical exclusion is
sufficient grounds for FDA to refuse to file or approve an application
(21 CFR 25.15(a), 314.101(d)(4) and 601.2(a) and (c)).
    Categorical exclusions for actions related to human drugs and
biologics are listed at 21 CFR 25.31. This guidance focuses on the
categorical exclusion for actions on NDAs and NDA supplements that
would increase the use of an active moiety, but the estimated
concentration of the substance at the point of entry into the aquatic
environment would be below 1 part per billion (1 ppb) (21 CFR
25.31(b)). Although an action that qualifies for this exclusion
ordinarily does not require an EA, FDA will require ``at least an EA''
if ``extraordinary circumstances'' indicate that the specific proposed
action (e.g., the approval of the NDA) may significantly affect the
quality of the human environment (21 CFR 25.21). Research indicates
that drugs with endocrine-related activity and, more specifically,
drugs with Estrogenic, Androgenic, or Thyroid Activity (E, A, or T)
activity have the potential to cause developmental or reproductive
effects when present in the aquatic environment at concentrations below
1 ppb.\1\
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    \1\ For example, see Section II.C (pp. 7-13) of USFDA, 2013,
``Response to Citizen Petition to the FDA Commissioner under the
National Environmental Policy Act and Administrative Procedure Act
Requesting an Amendment to an FDA Rule Regarding Human Drugs and
Biologics,'' Docket No. FDA-2010-P-0377; U.S. Environmental
Protection Agency (USEPA), Endocrine Disruptor Screening Program
(EDSP), last accessed February 17, 2015, at http://www.epa.gov/endo;
and Organisation for Economic Co-operation and Development (OECD),
OECD Work Related to Endocrine Disrupters, last accessed February
17, 2015, at http://www.oecd.org/env/ehs/testing/oecdworkrelatedtoendocrinedisrupters.htm.
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    FDA has, on a case-by-case basis, requested additional information
from sponsors of NDAs and NDA supplements for drugs with E, A, or T
activity to help it determine whether extraordinary circumstances
exist. However, late cycle requests for additional environmental
information have the potential to delay approval of applications.
Accordingly, this guidance is intended to clarify that sponsors of
drugs with potential E, A, or T activity should consult with the Agency
early in product development concerning the information FDA may need to
determine whether an EA will be required or whether a claim of
categorical exclusion will be acceptable, and what information should
be included in the EA or claim of categorical exclusion.
    This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
current thinking of FDA on Environmental Assessment: Questions and
Answers Regarding Drugs With Estrogenic, Androgenic, or Thyroid
Activity. It does not establish any rights for any person and is not
binding on FDA or the public. You can use an alternative approach if it
satisfies the requirements of the applicable statutes and regulations.

II. The Paperwork Reduction Act of 1995

    This guidance refers to previously approved collections of
information that are subject to review by the Office of Management and
Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-
3520). The collections of information in 21 CFR part 25 have been
approved under OMB control number 0910-0322 and the collections of
information in 21 CFR part 314 have been approved under OMB control
number 0910-0001.

III. Electronic Access

    Persons with access to the Internet may obtain the guidance at
either http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or http://www.regulations.gov.

    Dated: March 1, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-04964 Filed 3-4-16; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 76, Number 12 (Wednesday, January 19, 2011)]
[Notices]
[Pages 3126-3128]
[FR Doc No: 2011-1013]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-R03-OW-2009-0985; FRL-9254-8]

Final Determination of the Assistant Administrator for Water
Pursuant to Section 404(c) of the Clean Water Act Concerning the Spruce
No. 1 Mine, Logan County, WV

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: This is a notice of EPA's Final Determination pursuant to
section 404(c) of the Clean Water Act to withdraw the specification of
Pigeonroost Branch, Oldhouse Branch, and their tributaries, within
Logan County, West Virginia, as a disposal site for dredged or fill
material in connection with construction, operation, and reclamation of
the Spruce No. 1 Surface Mine, as authorized by DA Permit No.
199800436-3 (Section 10: Coal River). This determination also prohibits
the specification of the defined area constituting Pigeonroost Branch,
Oldhouse Branch, and their tributaries for use as a disposal site
associated with future surface coal mining that would be expected to
result in a nature and scale of adverse chemical, physical, and
biological effects similar to the Spruce No. 1 mine. EPA's
determination is based upon a finding that the discharge of dredged or
fill material associated with the construction and operation of the
Spruce No. 1 Mine would result in unacceptable adverse effects on
wildlife.

DATES: Effective Date: The effective date of the Final Determination is
January 13, 2011.

ADDRESSES: U.S. Environmental Protection Agency, Office of Water,
Wetlands Division, Mail Code 4502T, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460. EPA has established a docket for this action
under Docket ID No. EPA-R03-OW-2009-0985. All documents in the docket
are listed on the http://www.regulations.gov Web site. Although listed
in the index, some information may not be publicly available, e.g., CBI
or other information whose disclosure is restricted by statute. Certain
other material, such as copyrighted material, is not placed on the
Internet and will be publicly available only in hard copy form.
Publicly available docket materials are available either electronically
through http://www.regulations.gov or in hard copy at the Water Docket,
EPA/DC, EPA West, Room 3334, 1301 Constitution Ave., NW., Washington,
DC. The Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday
through Friday, excluding legal holidays. The telephone number for the
Public Reading Room is<PHONE_NUMBER>, and the telephone number for the
Water Docket is<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Mr. Chris Hunter, Office of Wetlands,
Oceans, and Watersheds; U.S. Environmental Protection Agency, Mail Code
4502T, 1200 Pennsylvania Ave., NW., Washington, DC 20460. Additional
information and copies of EPA's Final Determination are available at
the following Web site: http://www.epa.gov/404c/.

SUPPLEMENTARY INFORMATION: Section 404(c) of the CWA, 33 U.S.C.
1344(c), authorizes EPA to prohibit the specification (including the
withdrawal of specification) of any defined area as a disposal site.
EPA is authorized to restrict or deny the use of any defined area for
specification (including the withdrawal of specification) as a disposal
site, whenever it determines, after notice and opportunity for public
hearing, that the discharge of such materials into such area will have
an unacceptable adverse effect on municipal water supplies, shellfish
beds and fishery areas (including spawning and breeding areas),
wildlife, or recreational areas.
    EPA's regulations for implementing section 404(c) are set forth in
40 CFR part 231. Four major steps in the process are: (1) The Regional
Administrator's notice to the U.S. Army Corps of Engineers (the Corps),
the applicant or permittee, the property owner, and the State, as
appropriate, of the intention to initiate the section 404(c) process;
(2) the Regional Administrator's publication of a Proposed
Determination to withdraw, deny, restrict, or prohibit the use of the
site, soliciting public comment and offering an opportunity for a
public hearing; (3) the Regional Administrator's recommendation to the
Assistant Administrator for Water at EPA Headquarters to withdraw,
deny, restrict, or prohibit the use of the site (Recommended
Determination); and, (4) the Assistant Administrator for Water's

Final Determination to affirm, modify, or rescind the Regional
recommendation.
    As a result of significant new scientific information confirming
and strengthening EPA's concerns regarding the environmental effects of
mountaintop mining operations, and in particular those operations on
the scope and scale of the Spruce No. 1 Mine, EPA Region III initiated
the Clean Water Act Sec.  404(c) process for the Spruce No. 1 Mine on
October 16, 2009. The Spruce No. 1 Mine, as authorized in 2007 by
Department of the Army (DA) Permit No. 199800436-3 (Section 10: Coal
River), is one of the largest mountaintop mining projects ever
authorized in West Virginia. The DA Permit authorizes the Mingo Logan
Coal Company to construct six valley fills, associated sedimentation
structures, and other discharges of fill material to the Right Fork of
Seng Camp Creek, Pigeonroost Branch, Oldhouse Branch, and their
tributaries. If fully constructed, the project will disturb
approximately 2,278 acres (about 3.5 square miles) and bury
approximately 7.48 miles of streams beneath 110 million cubic yards of
excess spoil.\1\
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    \1\ EPA's Final Determination addresses only the 6.6 miles of
fill authorized in Pigeonroost Branch, Oldhouse Branch, and their
tributaries. While the permit also authorizes construction of valley
fills and other discharges to the Right Fork of Seng Camp Creek and
its tributaries, EPA is not withdrawing specification of those
waters, in part because some of those discharges have already
occurred and because the stream resources in Right Fork of Seng Camp
Creek were subject to a higher level of historic and ongoing human
disturbance than those found in Pigeonroost Branch or Oldhouse
Branch. Due to litigation and an agreement with environmental
groups, represented by Ohio Valley Environmental Coalition,
operations following the issuance of this DA Permit have been
limited to the Seng Camp Creek watershed, and as part of that
agreement one valley fill is partially constructed.
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    Following initiation of the Section 404(c) process, EPA Region III
communicated with representatives of Mingo Logan (a subsidiary of Arch
Coal, Inc.) and the Corps both in person and by telephone and
electronic mail on several occasions to determine whether corrective
action would be taken to address EPA Region III's concerns. However,
corrective action was not taken to resolve EPA's concerns. On April 2,
2010, EPA Region III published in the Federal Register a Proposed
Determination to prohibit, restrict, or deny the specification or the
use for specification (including withdrawal of specification) of
certain waters at the project site as disposal sites for the discharge
of dredged or fill material for the construction of the Spruce No. 1
Surface Mine. EPA Region III took this step because it believed that
discharges authorized by DA Permit No. 199800436-3 (Section 10: Coal
River) would result in a significant loss of wildlife habitat and also
cause significant degradation of downstream aquatic ecosystems and
therefore could have unacceptable adverse effects on wildlife. A public
hearing regarding the Proposed Determination was conducted on May 18,
2010. EPA Region III received more than 100 oral comments and more than
50,000 written comments both supporting and opposing its Proposed
Determination.
    On September 24, 2010, EPA Region III submitted to EPA Headquarters
its Recommended Determination that the specification embodied in DA
Permit No. 199800436-3 (Section 10: Coal River) of Pigeonroost Branch
and Oldhouse Branch as disposal sites for discharges of dredged or fill
material for construction of the Spruce No. 1 Surface Mine be
withdrawn. EPA Region III based this recommendation upon a conclusion
that the discharges of dredged or fill material to Pigeonroost Branch
and Oldhouse Branch for the purpose of constructing the Spruce No. 1
Surface Mine as authorized would likely have unacceptable adverse
effects on wildlife.
    The U.S. Fish and Wildlife Service (USFWS), in its comments on both
the Proposed and Recommended Determinations, concurred with EPA Region
III's conclusion that the project, as authorized, would result in
unacceptable adverse effects on wildlife and that this conclusion is
supported by the available scientific information. USFWS also noted
that it has consistently expressed concerns regarding the loss of
headwater streams and adjacent riparian and terrestrial habitats
associated with the Spruce No. 1 Mine, as well as its likely impacts on
downstream water quality, aquatic organisms, and terrestrial and
aquatic wildlife that depend on those resources.
    Following receipt of the Recommended Determination, and consistent
with EPA's Section 404(c) regulations, EPA Headquarters provided an
opportunity for the project's proponents to propose corrective actions
intended to prevent the unacceptable adverse environmental impacts
presented in the Recommended Determination. On November 16, 2010, a
consultation meeting was held at EPA Headquarters in Washington, DC to
discuss the Region III Recommended Determination and potential
corrective actions that could be undertaken to avoid the unacceptable
adverse impacts that were of concern to EPA. Participants at the
meeting included the EPA Assistant Administrator for Water; the EPA
Region III Regional Administrator; other EPA staff; representatives
from Arch Coal, Inc. (parent company of Mingo Logan) and their legal
counsel; the United Company (a mineral rights owner) and their legal
counsel; the West Virginia Department of Environmental Protection, and
the District Engineer of the Corps' Huntington District. At that
meeting, and in subsequent communications, Arch Coal did not provide
EPA with corrective actions that would meaningfully address the likely
unacceptable adverse effects outlined in Region III's Recommended
Determination.
    Following review of the public comments received, existing and
recently developed scientific data, and EPA Region III's Recommended
Determination, EPA has concluded that the discharge of dredged or fill
material to Pigeonroost Branch and Oldhouse Branch, in connection with
the construction of valley fills and sedimentation ponds, as authorized
by DA Permit No. 199800436-3 (Section 10: Coal River), will result in
unacceptable adverse effects on wildlife. The administrative record
developed in this case fully supports the conclusion that the Spruce
No. 1 Surface Mine will have unacceptable adverse effects to wildlife,
due to the filling of Pigeonroost Branch, Oldhouse Branch, and their
tributaries. In addition, the administrative record demonstrates that
the Spruce No. 1 Surface Mine will have unacceptable adverse effects on
wildlife downstream of the project site as a result of increased
pollution that the project will contribute to downstream waters.
    EPA has determined that unacceptable adverse impacts to Pigeonroost
Branch, Oldhouse Branch, and their tributaries will occur through the
direct burial of 6.6 miles of high-quality stream habitat, including
all wildlife in this watershed that utilize these streams for all or
part of their life cycles (e.g., macroinvertebrate, salamander, fish,
and water-dependent bird populations). Pigeonroost Branch, Oldhouse
Branch, and their tributaries contain diverse and high-quality wildlife
communities that are consistent with the ecological richness of high-
quality Appalachian headwater stream systems. With their adjacent
riparian areas, these streams provide important habitat for 84 taxa of
macroinvertebrates, up to 46 species of amphibians and reptiles, 4
species of crayfish, and 5 species of fish, as well as birds, bats, and
other mammals. As some of the last remaining high quality,

least-disturbed headwater stream habitat within the sub-basin, these
streams not only support resident wildlife, but also provide ecosystem
functions for downstream waters, serve as refugia for aquatic life and
potential sources for recolonizing nearby waters, and ultimately serve
to maintain the aquatic ecosystem integrity in the sub-basin and the
rich animal diversity in the ecoregion.
    Burial of Pigeonroost Branch, Oldhouse Branch, and their
tributaries will also result in unacceptable adverse effects on
wildlife downstream through the removal of functions performed by the
buried streams and by transformation of the buried areas into pollution
sources that will contribute contaminants to downstream waters. Based
on recent peer-reviewed literature, as well as available data from
adjacent mine sites and from the active portion of the Spruce No. 1
Mine, EPA has concluded that the full construction of the Spruce No. 1
Mine will transform these headwater streams from high-quality habitat
into sources of pollutants (particularly total dissolved solids and
selenium) that will travel downstream and adversely impact the wildlife
communities that utilize these downstream waters. Increased pollutant
levels will lead to loss of macroinvertebrate communities and
population shifts to more pollution-tolerant taxa, specifically the
extirpation of ecologically important macroinvertebrates. Through the
loss of stream macroinvertebrate communities, there will be, in turn,
substantial effects on fish, amphibian, and bird populations that rely
on these communities as a food source.
    Furthermore, the increased loading of pollutants to downstream
receiving waters will increase the potential for harmful golden algal
blooms, while increased selenium exposure will result in impaired
salamander populations and adverse effects to the reproduction of fish
and bird species, thus harming the ability of these local populations
to rebound. The loss of macroinvertebrate prey populations, increased
risk of harmful golden algal blooms, and additional exposure to
selenium will have an unacceptable adverse effect on the 26 fish
species found in Spruce Fork (the receiving stream for Pigeonroost
Branch and Oldhouse Branch), and will also have an unacceptable adverse
effect on amphibians, reptiles, crayfish, and bird species that depend
on downstream waters for food or habitat.
    Furthermore, these adverse impacts do not comply with the
requirements of the Clean Water Act (CWA) and EPA's implementing
regulations under section 404(b)(1). EPA has determined that the Spruce
No. 1 Surface Mine fails to adequately evaluate less environmentally
damaging alternatives, will cause or contribute to significant
degradation of waters of the United States (especially when considered
in the context of the significant cumulative losses and impairment of
streams across the Central Appalachian ecoregion), and lacks
compensatory mitigation to adequately offset the impacts to Pigeonroost
Branch and Oldhouse Branch. These failures to comply with the
Guidelines serve to strengthen EPA's judgment about the unacceptability
of the significant adverse impacts that will occur.
    Based on these findings and pursuant to section 404(c) of the CWA,
EPA's Final Determination withdraws the specification of Pigeonroost
Branch, Oldhouse Branch, and their tributaries, as described in DA
Permit No. 199800436-3 (Section 10: Coal River), as a disposal site for
the discharge of dredged or fill material for the purpose of
construction, operation, and reclamation of the Spruce No. 1 Surface
Mine. This Final Determination also prohibits the specification of the
defined area constituting Pigeonroost Branch, Oldhouse Branch, and
their tributaries for use as a disposal site associated with future
surface coal mining that would be expected to result in a nature and
scale of adverse chemical, physical, and biological effects similar to
the Spruce No. 1 mine. This Final Determination does not affect
discharges to Seng Camp Creek as authorized in DA Permit No.
19980043603 (Section 10: Coal River) associated with the Spruce No.1
Surface Mine.
    EPA continues to work effectively with the Corps, the mining
industry, and the public to evaluate proposed Appalachian surface coal
mining projects and to enable permitting of environmentally responsible
mining projects that authorize continued coal production while
preventing unacceptable adverse effects on wildlife.

    Dated: January 13, 2011.
Peter S. Silva,
Assistant Administrator, Office of Water.
[FR Doc. 2011-1013 Filed 1-18-11; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 78, Number 152 (Wednesday, August 7, 2013)]
[Notices]
[Pages 48218-48224]
[FR Doc No: 2013-19215]

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DEPARTMENT OF TRANSPORTATION

Federal Railroad Administration

[FRA Emergency Order No. 28, Notice No. 1]

Emergency Order Establishing Additional Requirements for
Attendance and Securement of Certain Freight Trains and Vehicles on
Mainline Track or Mainline Siding Outside of a Yard or Terminal

    The Federal Railroad Administration (FRA) of the United States
Department of Transportation (DOT) has determined that public safety
compels issuance of this Emergency Order (EO), which requires railroads
operating on the general system to implement additional processes and
procedures to ensure that certain unattended trains and vehicles \1\ on
mainline track or mainline siding outside of a yard or terminal are
properly secured against unintended movement. FRA re-examined its
regulations governing the securement of such equipment in light of the
July 6, 2013, derailment in Lac-M[eacute]gantic, Quebec, Canada, which
demonstrated the terrible consequences that can arise when a railroad
accident results in a sudden release of flammable liquids. FRA's
inspection data since January 2010 shows significant non-compliance
with FRA's securement regulations, 49 CFR 232.103(n), with nearly 4,950
recorded defects in that time. Moreover, FRA has seen a number of
serious accidents during rail transportation of flammable liquids since
2009, and there has been significant growth in these types of rail
shipments since 2011. These factors lead FRA to the conclusion that
additional action is necessary to eliminate an immediate hazard of
death, personal injury, or significant harm to the environment,
particularly in instances where certain hazardous materials are
involved. As a result, FRA is ordering that each railroad take the
following actions on mainline track or mainline siding outside of a
yard or terminal to ensure

the safe transportation by rail of hazardous material:
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    \1\ A vehicle, as defined in 49 U.S.C. 20301, ``means a car,
locomotive, tender, or similar vehicle.''
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    1. No train or vehicle transporting hazardous materials as
described in Appendix A shall be left unattended on a mainline track or
mainline siding outside of a yard or terminal until the railroad
develops, adopts, complies with and makes available to FRA upon
request, a plan that identifies specific locations and circumstances
when such trains or vehicles may be left unattended. The plan shall
contain a sufficient safety justification for any determination
allowing such trains or vehicles to be unattended. FRA will monitor
such plans and if FRA determines that adequate justification is not
provided, the railroad shall ensure that trains and equipment are
attended until appropriate modifications to the plan are completed. FRA
does not intend to grant approval to any plan. Each railroad shall
notify FRA when it has developed a plan under this provision prior to
the railroad operating pursuant to the plan.
    2. Develop processes for the securement of unattended trains or
vehicles transporting hazardous materials as described in Appendix A on
mainline track or mainline siding outside of a yard or terminal if
permitted by the railroad's plan required by this order that contains
the following requirements:
    a. The controlling locomotive cab must be locked or the reverser on
the controlling locomotive must be removed and secured, and
    b. Employees who are responsible for securing trains and vehicles
transporting hazardous materials as described in Appendix A must
communicate to the train dispatcher the number of hand brakes applied,
the tonnage and length of the train or vehicle, the grade and terrain
features of the track, any relevant weather conditions, and the type of
equipment being secured; train dispatchers must record the information
provided; and train dispatchers or other qualified railroad employees
must verify and confirm with the train crew that the securement meets
the railroad's requirements.
    3. Review and verify, and adjust, as necessary, existing procedures
and processes related to the number of hand brakes to be set on all
unattended trains and vehicles and ensure the means of verifying that
number is appropriate.
    4. Implement operating rules and practices requiring the discussion
of securement for any job that will impact or require the securement of
any train or vehicle in the course of the work being performed.
    5. Develop procedures to ensure that a qualified railroad employee
inspects all equipment that any emergency responder has been on, under,
or between for proper securement before the train or vehicle is left
unattended.
    Additionally, each railroad must provide notice of this EO to all
employees affected by this EO to ensure that they have knowledge of the
EO's requirements.

Authority

    Authority to enforce Federal railroad safety laws has been
delegated by the Secretary of Transportation to the Administrator of
FRA. 49 CFR 1.89. Railroads are subject to FRA's safety jurisdiction
under the Federal railroad safety laws. 49 U.S.C. 20101, 20103. FRA is
authorized to issue emergency orders where an unsafe condition or
practice ``causes an emergency situation involving a hazard of death,
personal injury, or significant harm to the environment.'' 49 U.S.C.
20104. These orders may immediately impose ``restrictions and
prohibitions . . . that may be necessary to abate the situation.'' Id.

Lac-M[eacute]gantic Derailment

    FRA has re-examined its requirements for securing trains and
vehicles on mainline track and mainline sidings outside of a yard or
terminal in the aftermath of the catastrophic July 6, 2013, accident
involving loaded tank cars containing petroleum crude oil that occurred
in the town of Lac-M[eacute]gantic, Quebec, Canada, on track owned by
Montreal, Maine & Atlantic Railway Corporation (MMA), a company
incorporated in the United States. While Canadian authorities are still
investigating the accident and no final conclusions have been made, the
following is known based on preliminary information released by the
Transportation Safety Board of Canada.
    According to Rail Safety Advisory Letters issued by the
Transportation Safety Board of Canada on July 19, 2013, the incident is
summarized as follows. At approximately 10:45 p.m. Eastern Daylight
Time (EDT) on July 5, 2013, MMA train 2 was proceeding eastward from
Montreal, Quebec, to St. John, New Brunswick. The train was
approximately 4,700 feet long and weighed over 10,000 tons. It
consisted of five locomotives, a loaded box car, and 72 loaded tank
cars containing petroleum crude oil (U.S. DOT Hazard Class 3, UN 1267).
At approximately 11:00 p.m. the train stopped near milepost 7.40 near
Nantes, Quebec. At that location the operator of the train secured it
and departed, leaving the train unattended on mainline track with a
descending grade of approximately 1.2 percent.
    At around 11:50 p.m. a local resident reported a fire on the
controlling locomotive (MMA 5017) of the train. The local fire
department was called and responded with another MMA employee. At
approximately midnight, the controlling locomotive was shut down and
the fire extinguished. After the fire was extinguished, the fire
department and the MMA employee left the site.
    At approximately 1:00 a.m. the next day (the early morning of July
6th) it appears that the train began rolling and picking up speed down
the descending grade toward the town of Lac-M[eacute]gantic, Quebec,
which sits approximately 30 miles from the United States-Canada border.
Near the center of town, the box car and 63 of the loaded tank cars
derailed. The locomotives, which separated from the train, traveled an
additional \1/2\ mile before coming to a stop. A number of derailed
tank cars released product resulting in multiple explosions and
subsequent fires. At this time, it is estimated that there were 42
fatalities and that 5 persons are still missing. There was also
extensive damage to the town, and approximately 2,000 people were
evacuated from the surrounding area. While the investigation is ongoing
and the Transportation Safety Board of Canada has not reached any final
conclusions, it has made a determination that the braking force applied
to the train was insufficient to hold it on the 1.2-percent descending
slope between Nantes and Lac-M[eacute]gantic.
    In response to this accident, Transport Canada (the Canadian
government department responsible for regulating transportation safety
in Canada) issued an emergency railroad directive pursuant to Section
33 of the Canadian Railway Safety Act.\2\ While Transport Canada
explained in the emergency directive that the cause of the accident in
Lac-M[eacute]gantic remains unknown, the emergency directive stated
that:

    \2\ Available online at: http://www.tc.gc.ca/eng/mediaroom/backgrounders-safety-locomotives-7292.html. Additionally, in
response to this accident, the Transportation Safety Board of Canada
issued Rail Safety Advisory Letter--09/13 regarding the securement
of equipment and trains left unattended; available online at: http://www.tsb.gc.ca/eng/medias-media/sur-safe/letter/rail/2013/r13d0054/r13d0054-617-09-13.asp.
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    [I]n light of the catastrophic results of the Lac-
M[eacute]gantic accident and in the interest of ensuring the
continued safety and security of railway transportation, there is an
immediate need to clarify the regime respecting unattended
locomotives on main track and sidings and the transportation of
dangerous

goods in tank cars using a one person crew to address any threat to
---------------------------------------------------------------------------
the safety and security of railway operations.

    As such, Transport Canada exercised its statutory emergency
directive authority to order railroad companies operating in Canada to
comply with certain requirements related to unauthorized entry into
locomotive cabs, directional controls on locomotives, the application
of hand brakes to cars left unattended for more than one hour, setting
of the automatic brake and independent brake on any locomotive attached
to cars that is left unattended for one hour or less, attendance
related to locomotives attached to loaded tank cars transporting
dangerous goods on main track, and the number of crew members assigned
to a locomotive attached to loaded tank cars transporting dangerous
goods on a main track or siding.
    In addition, Transport Canada issued an accompanying order pursuant
to paragraph 19(a)(1) of the Canadian Railway Safety Act directing
railroad companies in Canada to formulate or revise certain railroad
operating rules, respecting the safety and security of unattended
locomotives, uncontrolled movements, and crew size requirements. The
order provides that rules should be based on an assessment of safety
and security risks, and shall at a minimum ensure that the cab(s) of
unattended controlling locomotives are secure against unauthorized
entry; ensure that the reversers of unattended locomotives are removed
and secured; prevent uncontrolled movements of railway equipment by
addressing the application of hand brakes; ensure the security of
stationary railway equipment transporting dangerous goods; and provide
for minimum operating crew requirements considering technology, length
of train, speeds, classification of dangerous goods being transported,
and other risk factors.
    DOT is taking actions consistent with Transport Canada to ensure
the safe transportation of products by rail in the United States, with
a particular focus on certain hazardous materials that present an
immediate danger for communities and the environment in the event of a
train accident. Through this EO, FRA is addressing the immediate
dangers that arise from unattended equipment that is left unsecured.
Additionally, FRA and the Pipeline and Hazardous Materials Safety
Administration (PHMSA) are issuing a joint Safety Advisory to railroads
and commodity shippers detailing eight recommended actions the industry
should take to better ensure the safe transport of hazardous materials.
These recommendations include the following: Reviewing the details and
lessons learned from the Lac-M[eacute]gantic accident; reviewing crew
staffing levels; removing and securing the train's ``reverser'' when
unattended; a thorough review of all railroad operating procedures,
testing and operating rules around securing a train; reviewing
Transport Canada's directives to secure and safely operate a train; and
conducting a system-wide assessment of security risks when a train is
unattended and identifying mitigation efforts for those risks.
Additionally, the Safety Advisory recommends testing and sampling of
crude oil for proper classification for shipment, as well as a review
of all shippers' and carriers safety and security plans. Finally, FRA
is convening an emergency meeting of FRA's Railroad Safety Advisory
Committee to begin the deliberative process with FRA's stakeholders,
including railroad management, railroad labor, shippers, car owners,
and others, as the agency considers recommendations in the Safety
Advisory that should be made a part of its regulations.

Safety Concerns Arising Out of the Lac-M[eacute]gantic Derailment

    Generally, the transportation of hazardous materials by rail is
extremely safe. The vast majority of hazardous materials shipped by
rail each year arrive at their destinations safely and without
incident. Indeed, in calendar year 2011, there were only 20 accidents
in which a hazardous material was released out of approximately 2.2
million shipments of hazardous material transported by rail in the
United States. However, the Lac-M[eacute]gantic incident demonstrates
the substantial potential for danger that exists when an unattended
train rolls away and derails resulting in the sudden release of
hazardous materials into the environment. Although the Lac-
M[eacute]gantic incident occurred in Canada, the freight railroad
operating environment in Canada is similar to that in the United
States, and a number of railroads operate in both countries.\3\ Freight
railroads in the United States also transport a substantial amount and
variety of hazardous materials, including materials poisonous by
inhalation (PIH), materials or toxic by inhalation (TIH), and explosive
materials. Moreover, an increasing proportion of the hazardous
materials being transported by rail is classified as flammable.\4\
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    \3\ As an example, MMA operates both in the United States and
Canada, with approximately 510 miles of track in Maine, Vermont, and
Quebec, and the tank cars transporting the crude oil that derailed
in Lac-M[eacute]gantic originated in the Williston Basin of North
Dakota.
    \4\ PHMSA prescribes a comprehensive regulatory safety system
that categorizes hazardous materials into nine hazard classes based
on the type of hazards presented by the materials. See 49 CFR Parts
172 and 173. Under PHMSA's regulations, crude oil, in most forms,
meets the definition of a ``Class 3'' hazardous material, which
signifies that it is a flammable liquid. Ethanol, discussed below,
also is a Class 3 hazardous material. PIH materials, referenced
above, include ``Class 2 and Division 2.3'' gases and ``Class 6, and
Division 6.1'' poisons other than gases. Chlorine gas and anhydrous
ammonia are two examples of PIH materials (Division 2.3) that are
commonly transported by rail.
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    The MMA train in the Lac-M[eacute]gantic incident was transporting
72 carloads of petroleum crude oil with five locomotives and a loaded
box car. A similar type of train consist is commonly found on rail
lines in the United States because crude oil is often transported in
units of cars or by a unit train consisting virtually entirely of tank
cars containing crude oil. Crude oil is often classified by an offeror
as a flammable liquid; per PHMSA's Hazmat Regulations (HMR), however,
its packing group can be I, II, or III depending on the blend of
constituent crude oils. According to the Association of American
Railroads (AAR), crude oil traffic increased 443 percent in the United
States between 2005 and 2012. Much of this growth has occurred because
of developments in North Dakota, as the Bakken formation in the
Williston Basin has become a major source for oil production in the
United States. Texas also has contributed to the growth of crude oil
shipments by rail. As a result, carloads of crude oil increased from
approximately 65,600 in 2011 to approximately 257,450 in 2012. The
Bakken crude oil from North Dakota is primarily shipped via rail to
refineries located near the U.S. Gulf Coast--particularly in Texas and
Louisiana--or also to pipeline connections, most notably to connections
located in Oklahoma. Crude oil is also shipped via rail to refineries
on the East Coast and, to a lesser extent, refineries in other regions
of the U.S.\5\
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    \5\ See AAR's May 2013 paper ``Moving Crude Oil by Rail''
available online at: https://www.aar.org/keyissues/Documents/Background-Papers/Crude-oil-by-rail.pdf.
---------------------------------------------------------------------------

    All indications from the U.S. Energy Information Administration
(EIA) within the U.S. Department of Energy are that rail export
capacity for Bakken crude oil from the Williston Basin will continue to
expand to meet production.\6\

Rail exports from the North Dakota region are forecast to increase over
the next two years (as are pipeline exports). Much of the near-term
growth in rail originations right now is a function of how quickly tank
car manufacturers can produce new cars to meet the demand for tank
cars, primarily for transporting Bakken crude oil. The rise in rail
originations in crude oil is subject to changes in the number of tank
cars available, price of crude oil, and overall production of crude oil
in that region, and is also dependent on whether, or how quickly,
additional pipeline export capacity from that region comes online.
However, for the foreseeable future, all indications are for continued
growth of rail originations of crude in that region as new tank car
fleets come online to meet demand.
---------------------------------------------------------------------------

    \6\ See EIA reports ``Bakken crude oil price differential to WTI
narrows over last 14 months,'' available online at: http://www.eia.gov/todayinenergy/detail.cfm?id=10431; and ``Rail delivery
of U.S. oil and petroleum products continues to increase, but pace
slows,'' available online at: http://www.eia.gov/todayinenergy/detail.cfm?id=12031.
---------------------------------------------------------------------------

    As demonstrated by the Lac-M[eacute]gantic derailment, in a
catastrophic incident, crude oil is problematic when released because
it is flammable. This risk is compounded because it is commonly shipped
in large units. Similar dangers exist with other hazardous materials
such as ethanol, which is another flammable liquid that is commonly
transported by rail. More carloads of ethanol were transported via rail
than any other hazardous material in 2012. Ethanol experienced an
increase in traffic of 442 percent between 2005 and 2010. Although in
2012 the number of carloads dropped by 11 percent from 2010 levels,
there were still approximately 366,000 carloads transported by rail.
Since 2009, there have been at least four serious mainline derailments
resulting in the breach of tank cars containing ethanol. While FRA
recognizes that none of these four derailments resulted from a roll-
away situation, they are instructive on the destructive potential of a
derailment involving tank cars containing flammable products:
     On June 19, 2009, in Cherry Valley, IL, a Canadian
National Railway train derailed 19 tank cars loaded with ethanol.
Thirteen of the 19 derailed cars caught fire, and there were reports of
explosions. One person died, and there were 9 reported injuries related
to the fire. Additionally, approximately 600 residences were evacuated
within a \1/2\-mile radius of the derailment.
     On February 6, 2011, in Arcadia, OH, a Norfolk Southern
Railway Co. (Norfolk Southern) train operating on single main track
derailed 33 tank cars loaded with ethanol. The derailment caused a
major fire and forced the evacuation of a one-mile radius around the
derailment.
     On July 11, 2012, in Columbus, OH, a Norfolk Southern
train derailed while operating on main track. Thirteen tank cars
containing ethanol derailed resulting in a fire and the evacuation of
100 people within a one-mile radius of the derailment.
     On August 5, 2012, in Plevna, MT, a BNSF Railway Co. train
derailed 18 cars while en route from Baker, MT. Seventeen of the 18
cars were tank cars loaded with denatured alcohol, a form of ethanol.
Five of the cars caught on fire resulting in explosions, the burning of
surrounding property not within the railroad's right-of-way, and the
evacuation of the immediate area.
    Although these accidents were serious, their results had potential
for more catastrophic outcomes. The catastrophic releases created the
potential for additional deaths, injuries, property damage, and
environmental damage.
    There are other hazardous materials that have similar potential for
catastrophic danger. For example, accidents involving trains
transporting other hazardous materials, including PIH materials, such
as chlorine and anhydrous ammonia, can also result in serious
consequences as evidenced by the following accidents:
     On July 18, 2001, 11 of 60 cars in a CSX Transportation,
Inc. freight train derailed while passing through the Howard Street
Tunnel in downtown Baltimore, MD. The train included 8 tank cars loaded
with hazardous material; 4 of these were among the cars that derailed.
A leak in a tank car containing tripropylene resulted in a chemical
fire. A break in a water main above the tunnel flooded both the tunnel
and the streets above it, resulting in the tunnel collapsing.
     On January 18, 2002, a Canadian Pacific Railway train
containing 15 tank cars of anhydrous ammonia derailed half a mile from
the city limits of Minot, ND due to a breaking of the rail at a joint.
Five of these tank cars ruptured catastrophically, resulting in an
ammonia vapor that spread 5 miles downwind over an area where 11,600
people lived. The accident caused one death, 11 serious injuries, and
322 minor injuries. Environmental cleanup costs reported to the
National Transportation Safety Board (NTSB) were $8 million.
     On June 28, 2004, near Macdona, TX, a Union Pacific
Railroad Company train passed a stop signal and collided with a BNSF
train. A chlorine car was punctured and the chlorine gas that was
released killed three and injured 32.
     On January 6, 2005, in Graniteville, SC, a Norfolk
Southern train collided with another Norfolk Southern train that was
parked on a customer side track, derailing both locomotives and 16 cars
of the moving train. The accident was caused by a misaligned switch.
Three tank cars containing chlorine derailed, one of which was
punctured. The resulting chlorine exposure caused 9 deaths,
approximately 554 people were taken to local hospitals, and an
additional 5,400 people within a one-mile radius of the site were
evacuated by law enforcement personnel. FRA's analysis of the total
cost of the accident was $126 million, including fatalities, injuries,
evacuation costs, property damage, environmental cleanup, and track out
of service.
    While train accidents involving hazardous materials are caused by a
variety of factors, nearly one-half of all accidents are related to
railroad human factors or equipment defects. FRA's data shows that
since 2009, human factors have been the most common cause of reportable
train accidents. Based on FRA's accident reporting data for the period
from 2009 through 2012, 35.7 percent of train accidents were human
factor-caused. With regard to the securement of unattended equipment,
specifically, FRA accident data indicates that approximately 8.5
percent of human factor-caused train accidents from calendar year 2011
until April 2013 were the result of improper securement. This EO is
intended to address some of the human factors failures that may cause
unattended equipment to be improperly secured to protect against a
derailment situation similar to that which occurred in Lac-
M[eacute]gantic.

Securement Requirements

    As previously noted, FRA has issued regulations designed to ensure
that trains and vehicles are properly secured before being left
unattended. See Sec.  232.103(n). ``Unattended equipment'' is defined
as ``equipment left standing and unmanned in such a manner that the
brake system of the equipment cannot be readily controlled by a
qualified person.'' Id. Section 232.103(n) addresses the securement of
unattended equipment by stating that a train's air brakes must not be
depended on to hold equipment standing unattended on a grade and
further requires the application of a sufficient number of hand brakes
to hold the equipment with the air brakes released and the ventilation
of the brake pipe pressure to zero with the angle cock opened on one
end of a cut of cars when not connected to a locomotive or other

compressed air source. The regulations also require railroads to
develop a process or procedure for verifying that the hand brakes that
are applied are sufficient to hold the equipment with the air brakes
released. When dealing with locomotives and locomotive consists, Sec.
232.103(n)(3) establishes specific additional requirements:
     All hand brakes must be fully applied on all locomotives
in the lead consist of an unattended train.
     All hand brakes must be fully applied on all locomotives
in an unattended locomotive consist outside of yard limits.
     The minimum requirement for an unattended locomotive
consist within yard limits is that the hand brake must be fully applied
on the controlling locomotive.
     Railroads must develop, adopt, and comply with procedures
for securing any unattended locomotive that is not equipped with an
operative hand brake.
    Additionally, FRA requires each railroad to adopt and comply with
instructions addressing the throttle position, status of the reverse
lever (commonly referred to as a ``reverser''), position of the
generator field switch, status of the independent brakes, position of
the isolation switch, and position of the automatic brake valve of an
unattended locomotive. See Sec.  232.103(n)(4).
    In FRA's view, these regulations--when followed--substantially
reduce the risk of movement of unattended equipment. However, FRA has
found there is significant non-compliance among the railroads with
respect to FRA's securement regulations. With limited resources, FRA
can inspect only a small percentage of trains and vehicles for
regulatory compliance. However, even with its limited resources, FRA
has recorded nearly 4,950 securement defects in the course of its
inspections since January 2010, an average of approximately 1,483
defects per year. With increased shipments of hazardous materials such
as crude oil and ethanol, securement non-compliance, particularly on
mainline track and mainline sidings outside of a yard or terminal, has
become a serious, immediate safety concern. Therefore, additional
measures are necessary to protect the health and safety of railroad
employees, the general public, and the environment.
    First, in this EO, FRA is prohibiting railroads from leaving trains
or vehicles that are transporting hazardous materials as described in
Appendix A unattended on mainline track or mainline siding outside of a
yard or terminal unless the railroad adopts and complies with a plan
that identifies the specific locations and circumstances for which it
is safe and suitable for leaving such trains or vehicles unattended.
The plan must contain sufficient analysis of the safety risks and any
mitigating circumstances the railroad has considered in making its
determination. FRA does not intend to grant approval to any plan, per
se. However, FRA will monitor such plans and if FRA determines that
adequate justification is not provided, the railroad shall ensure that
trains and equipment are attended until appropriate modifications are
made to the railroad's plan.
    Second, FRA is requiring railroads to develop specific processes
for employees responsible for securing any unattended train or vehicles
transporting hazardous materials as described in Appendix A that must
be left on mainline track or a mainline siding outside of a yard or
terminal. The employees responsible for securing the train or vehicles
must lock the controlling locomotive cab door before leaving it
unattended or remove and secure the reverser. The reverser is the
directional control for the locomotive. Removing it would put the
locomotive in neutral, preventing it from moving forward or backward
under the power of the engine. Additionally, employees must communicate
to the train dispatcher the number of hand brakes applied, the tonnage
of the train or vehicle, the grade and terrain features of the track,
any other relevant weather conditions, and the type of equipment being
secured. The dispatcher is then required to record the information
provided by the employee. Finally, the dispatcher or other qualified
railroad employee must verify and confirm with the train crew that the
securement meets the railroad's requirements. This requirement provides
a check on those individuals setting hand brakes to ensure appropriate
securement procedures are followed. The requirement is similar to FRA's
existing regulations that require employees to report to the train
dispatcher when a main track switch in non-signaled territory has been
restored to normal position and locked. FRA believes this type of
notification and verification requirement will help ensure that
employees responsible for securing equipment containing hazardous
materials will follow appropriate procedures because the employee will
need to fully consider the securement procedures in order to relay what
was done to the dispatcher. Further, the dispatcher or other qualified
railroad employee (e.g. a trainmaster, road foreman of engines, or
another train crew employee) will be in a position to ensure that a
sufficient number of hand brakes have been applied.
    Third, this E.O. requires that railroads review, verify, and
adjust, as necessary, existing requirements and instructions related to
the number of hand brakes to be set on unattended trains and vehicles
and that railroads review and adjust, as necessary, the procedures for
verifying that the number of hand brakes is sufficient to hold the
train or vehicle with the air brakes released. FRA's concern is that
existing railroad processes and procedures related to setting and
verifying hand brakes on unattended trains and equipment may not be
sufficient to hold all trains and vehicles in all circumstances. FRA
expects that the procedures and number of hand brakes required to be
set will vary significantly, depending on a variety of factors,
including, but not limited to: The length and weight of the train or
vehicle(s), the location, the grade and other terrain features of the
track, the weather conditions, the type of equipment being secured, and
whether the hand brakes apply on one or more trucks of a piece of
equipment. The procedures should also ensure that an additional margin
of safety is provided when determining the number of hand brakes to be
set in order to compensate for the differing ability of individuals to
set a hand brake at a specified level. FRA also expects railroads to
develop appropriate procedures to be followed by their employees to
test or verify that the number of hand brakes set will hold the
equipment with the air brakes released.
    Fourth, this E.O. requires railroads to implement operating rules
and practices requiring the job briefing of securement among
crewmembers and other involved railroad employees before engaging in
any job that will impact or require the securement of any train or
vehicle in the course of the work being performed. This requirement is
analogous to other Federal regulations that require crewmembers to have
a job briefing before performing various tasks, such as confirming the
position of a main track switch before leaving an area. The purpose of
this job briefing requirement is to make certain that all crewmembers
and other involved railroad employees are aware of what is necessary to
properly secure the equipment in compliance with Sec.  232.103(n).
    Finally, FRA is requiring railroads to develop procedures to ensure
that a qualified railroad employee inspects all equipment that any
emergency responder has been on, under, or

between for proper securement before the rail equipment or train is
left unattended. One of the facts that has come to light in the
aftermath of the Lac-M[eacute]gantic derailment is that first
responders were at milepost 7.4 near Nantes (along with an MMA
employee) to check a report of a fire on the train. This was well after
the operator had secured the train and left it unattended. Because it
may be necessary for emergency responders to modify the state of the
equipment if it is necessary for them to go on, under, or between
equipment in order to perform their jobs, it is critical for the
railroad to have a qualified employee inspect the equipment after the
emergency responders have completed their jobs to ensure that the
equipment is properly secured before it is again left unattended.

Finding and Order

    While FRA recognizes that the transportation of hazardous materials
by rail is extremely safe and that the vast majority of hazardous
materials shipped by rail each year arrive at their destinations safely
and without incident, FRA finds that there are gaps in the regulatory
scheme that create an emergency situation involving a hazard of death,
personal injury, or significant harm to the environment, with respect
to securement of unattended vehicles and trains transporting a
hazardous material of the type described in Appendix A to this E.O. on
mainline track and mainline sidings outside of a yard or terminal.
Accordingly, pursuant to the authority of 49 U.S.C. 20104, delegated to
the FRA Administrator by the Secretary of Transportation, 49 CFR 1.89,
it is hereby ordered that each railroad must institute and carry out
the following measures, effective within 30 days after the date of this
order:
    1. No train or vehicles transporting the type and quantity of
hazardous materials described in Appendix A (Appendix A Materials)
shall be left unattended on a mainline track or mainline siding outside
of a yard or terminal until the railroad develops, adopts, complies
with and makes available to FRA upon request a plan that identifies
specific locations and circumstances when such trains or vehicles may
be left unattended. The plan shall contain a sufficient safety
justification for any determination allowing such trains or vehicles to
be unattended. FRA will monitor such plans and if FRA determines that
adequate justification is not provided, the railroad shall ensure that
trains and equipment are attended until appropriate modifications to
the plan are completed. FRA does not intend to grant approval to any
plan. Railroads shall notify FRA when the railroad has developed a plan
under this provision prior to the railroad operating pursuant to the
plan.
    2. Railroads shall develop processes for securing unattended trains
or vehicles transporting Appendix A Materials on a mainline track or
mainline siding outside of a yard or terminal if permitted by the
railroad's plan required under paragraph (1) of this order that
contains the following requirements:
    a. The controlling locomotive cab must be locked or the reverser on
the controlling locomotive must be removed and secured.
    b. Employees who are responsible for securing trains and vehicles
transporting Appendix A Materials must communicate to the train
dispatcher the number of hand brakes applied, the tonnage and length of
the train or vehicle, the grade and terrain features of the track, any
relevant weather conditions, and the type of equipment being secured;
train dispatchers must record the information provided; and train
dispatchers or other qualified railroad employees must verify and
confirm with the train crew that the securement meets the railroad's
requirements.
    3. Railroads shall review and verify, and adjust, as necessary,
existing procedures and processes related to the number of hand brakes
to be set on all unattended trains and equipment and shall ensure the
means of verifying that number is appropriate.
    4. Railroads shall implement operating rules and practices
requiring the job briefing of securement for any job that will impact
or require the securement of any train or vehicle in the course of the
work being performed.
    5. Railroads shall develop procedures to ensure that a qualified
railroad employee inspects all equipment that any emergency responder
has been on, under, or between for proper securement before the train
or vehicle is left unattended.
    6. Notice of this E.O. shall be provided to all employees affected
by this E.O..

Relief

    Petitions for special approval to take actions not in accordance
with this E.O. may be submitted to the Associate Administrator for
Railroad Safety/Chief Safety Officer (Associate Administrator), who
shall be authorized to dispose of those requests without the necessity
of amending this E.O.. In reviewing any petition for special review,
the
    Associate Administrator shall grant petitions only in which a
petitioner has clearly articulated an alternative action that will
provide, in the Associate Administrator's judgment, at least a level of
safety equivalent to that provided by this E.O..

Penalties

    Any violation of this order or the terms of any written plan
adopted pursuant to this order to provide alternate protection shall
subject the person committing the violation to a civil penalty of up to
$105,000. 49 U.S.C. 21301. Any individual who willfully violates a
prohibition stated in this order is subject to civil penalties under 49
U.S.C. 21301. In addition, such an individual whose violation of this
order demonstrates the individual's unfitness for safety-sensitive
service may be removed from safety-sensitive service on the railroad
under 49 U.S.C. 20111. If appropriate, FRA may pursue criminal
penalties under 49 U.S.C. 522(a) and 49 U.S.C. 21311(a), as well as 18
U.S.C. 1001, for the knowing and willful falsification of a report
required by this order. FRA may, through the Attorney General, also
seek injunctive relief to enforce this order. 49 U.S.C. 20112.

Effective Date and Notice to Affected Persons

    Upon issuance of this E.O., railroads shall immediately initiate
steps to implement this E.O.. Railroads shall complete implementation
no later than September 1, 2013. Notice of this E.O. will be provided
by publishing it in the Federal Register.

Review

    Opportunity for formal review of this E.O. will be provided in
accordance with 49 U.S.C. 20104(b) and section 554 of title 5 of the
United States Code. Administrative procedures governing such review are
found at 49 CFR part 211. See 49 CFR 211.47, 211.71, 211.73, 211.75,
and 211.77.

    Issued in Washington, DC, on August 2, 2013.
Joseph C. Szabo,
Administrator.

Appendix A to Emergency Order 28

    (1) Five or more tank car loads of any one or any combination of
materials poisonous by inhalation as defined in 49 CFR 171.8, and
including anhydrous ammonia (UN 1005) and ammonia solutions (UN
3318); or
    (2) 20 rail car loads or intermodal portable tank loads of any
one or any combination of materials listed in (1) above, or, any
Division 2.1 flammable gas, Class 3 flammable liquid or combustible
liquid, Class 1.1 or 1.2

explosive, or hazardous substance listed in 49 CFR 173.31(f)(2).\7\
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    \7\ See 49 CFR 173.115 for the definition of Division 2.1
flammable gas, 173.120 for definition of Class 3 flammable liquid;
and 173.50 for the definition of the various classes of explosives.

[FR Doc. 2013-19215 Filed 8-6-13; 8:45 am]
BILLING CODE 4910-06-P


[Federal Register Volume 77, Number 95 (Wednesday, May 16, 2012)]
[Rules and Regulations]
[Pages 28770-28771]
[FR Doc No: 2012-11807]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket No. USCG 2012-0203]

Safety Zone; Fourth of July Fireworks, City of Eureka, CA

AGENCY: Coast Guard, DHS.

ACTION: Notice of enforcement of regulation.

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SUMMARY: The Coast Guard will enforce the safety zone for the City of
Eureka Fourth of July Fireworks in the Captain of the Port, San
Francisco area of responsibility during the dates and times noted
below. This action is necessary to protect life and property of

the maritime public from the hazards associated with the fireworks
display. During the enforcement period, unauthorized persons or vessels
are prohibited from entering into, transiting through, or anchoring in
the safety zone, unless authorized by the Patrol Commander (PATCOM).

DATES: The regulations in 33 CFR 165.1191 will be enforced from 12 p.m.
on July 3, 2012 through 10:45 p.m. on July 4, 2012.

FOR FURTHER INFORMATION CONTACT: If you have questions on this notice,
call or email Ensign William Hawn, Sector San Francisco Waterways
Safety Division, U.S. Coast Guard; telephone<PHONE_NUMBER>, email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: The Coast Guard will enforce a safety zone
in navigable waters around and under the fireworks barge within a
radius of 100 feet during the loading, transit, and arrival of the
fireworks barge to the display location and until the start of the
fireworks display. From 12 p.m. on July 3, 2012 until 3 p.m. on July 4,
2012 the fireworks barge will be loaded off of Schneider Dock in
Eureka, CA at position 40[deg]47'50'' N, 124[deg]11'11'' W (NAD 83).
From 3 p.m. to 4 p.m. on July 4, 2012 the loaded barge will transit
from Schneider Dock to the launch site off of Woodley Island near the
City of Eureka, CA at position 40[deg]48'29'' N, 124[deg]10'06'' W (NAD
83) where it will remain until the commencement of the fireworks
display. Upon the commencement of the fireworks display, scheduled to
take place from 10 p.m. to 10:25 p.m. on July 4, 2012, the safety zone
will increase in size to encompass the navigable waters around and
under the fireworks barge within a radius 1,000 feet at position
40[deg]48'29'' N, 124[deg]10'06'' W (NAD 83) for the City of Eureka
Fourth of July Fireworks in 33 CFR 165.1191. This safety zone will be
in effect from 12 p.m. on July 3, 2012 until 10:45 p.m. on July 4,
2012.
    Under the provisions of 33 CFR 165.1191, unauthorized persons or
vessels are prohibited from entering into, transiting through, or
anchoring in the safety zone during all applicable effective dates and
times, unless authorized to do so by the PATCOM. Additionally, each
person who receives notice of a lawful order or direction issued by an
official patrol vessel shall obey the order or direction. The PATCOM is
empowered to forbid entry into and control the regulated area. The
PATCOM shall be designated by the Commander, Coast Guard Sector San
Francisco. The PATCOM may, upon request, allow the transit of
commercial vessels through regulated areas when it is safe to do so.
This notice is issued under authority of 33 CFR 165.1191 and 5 U.S.C.
552(a). In addition to this notice in the Federal Register, the Coast
Guard will provide the maritime community with extensive advance
notification of the safety zone and its enforcement period via the
Local Notice to Mariners.
    If the Captain of the Port determines that the regulated area need
not be enforced for the full duration stated in this notice, a
Broadcast Notice to Mariners may be used to grant general permission to
enter the regulated area.

    Dated: April 27, 2012.
Cynthia L. Stowe,
Captain, U.S. Coast Guard, Captain of the Port San Francisco.
[FR Doc. 2012-11807 Filed 5-15-12; 8:45 am]
BILLING CODE 9110-04-P


From:  Kiechle, Fredric S<EMAIL_ADDRESS>Sent: Friday, June 10, 2016 2:11 PM To:  Jones, DonnaLee<EMAIL_ADDRESS>Raymond, Gabrielle<EMAIL_ADDRESS>Cc: Zavoda, Rich<EMAIL_ADDRESS>Hill, John R<EMAIL_ADDRESS>May, Jeffrey X<EMAIL_ADDRESS>Maciel, Robert A<EMAIL_ADDRESS>Subject:  EPA COKE ICR - COG Heat Content BTU data submittal in lieu of testing, ArcelorMittal Burns Harbor, LLC

Dr.  Jones,

Footnote 11 of Enclosure 2 of the Coke ICR (Test Procedures, Methods, and Reporting Requirements for Coke Oven Facilities, 04/04B/16) allows a facility to measure the heat content of the inlet flare gas in lieu of pollutant testing for toluene soluble organics (TSO), carbon monoxide (CO), semi-volatile HAPs and speciated volatile HAPs.  Please see the attached Coke Oven Gas (COG) higher heating value (HHV) from calendar year 2015.  The data is being timely submitted in accordance with the Coke ICR timeline for the week of June 6, 2016.  Based on the Coke ICR language and previous discussions, the attached heat content data will relieve the facility from testing the COG inlet flare gas.

Sincerely,

F. Scott Kiechle

F. Scott Kiechle  Sr. Engineer-Environmental ArcelorMittal Burns Harbor Maintenance, Environmental & Utilities | 250 W. U.S. Highway 12 Burns Harbor, IN 46304-9745 T +219 787 4968 | F +219 787 4973  | M +219 313 2661  | www.arcelormittal.c   Qapla'!

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