Document ID: PHMSA-2016-0014-0035
Agency: phmsa
Document Type: Rule
Title: Hazardous Materials: Enhanced Safety Provisions for Lithium Batteries Transported by Aircraft
Posted Date: 2022-12-21T05:00Z

[Federal Register Volume 87, Number 244 (Wednesday, December 21, 2022)]
[Rules and Regulations]
[Pages 77995-78011]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-27563]

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

DEPARTMENT OF TRANSPORTATION

Pipeline and Hazardous Materials Safety Administration

49 CFR Parts 107, 171, and 173

[Docket No. PHMSA-2016-0014 (HM-224I)]
RIN 2137-AF20

Hazardous Materials: Enhanced Safety Provisions for Lithium 
Batteries Transported by Aircraft (FAA Reauthorization Act of 2018)

AGENCY: Pipeline and Hazardous Materials Safety Administration (PHMSA), 
Department of Transportation (DOT).

ACTION: Final rule.

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

SUMMARY: This final rule revises the Hazardous Materials Regulations 
for lithium cells and batteries transported by aircraft and is 
consistent with the previously published Interim Final Rule, which 
responded to congressional mandates; prohibited the transport of 
lithium ion cells and batteries as cargo on passenger aircraft; 
required lithium ion cells and batteries to be shipped at not more than 
a 30 percent state of charge aboard cargo-only aircraft when not packed 
with or contained in equipment; and limited the use of alternative 
provisions for smaller lithium cell or battery shipments to one package 
per consignment. In response to comments, this final rule provides 
editorial amendments and modification of certain provisions including 
marking requirements, requests for an extension on the compliance date, 
and exception for lithium cells or batteries used for medical devices 
with approval by the Associate Administrator.

DATES: This final rule is effective on January 20, 2023.

FOR FURTHER INFORMATION CONTACT: Eugenio Cardez, (202) 366-9542, 
Standards and Rulemaking Division, Pipeline and Hazardous Materials 
Safety Administration, U.S. Department of Transportation, 1200 New 
Jersey Avenue SE, Washington, DC 20590-0001.

SUPPLEMENTARY INFORMATION: 

Table of Contents

I. Executive Summary
II. Background
III. IFR Comment Discussion
IV. Section-by-Section Review
V. Regulatory Analysis and Notices
    A. Statutory/Legal Authority
    B. Executive Order 12866 and DOT Regulatory Policies and 
Procedures
    C. Executive Order 13132
    D. Executive Order 13175
    E. Regulatory Flexibility Act and Executive Order 13272
    F. Paperwork Reduction Act
    G. Unfunded Mandates Reform Act of 1995
    H. Environmental Assessment
    I. Executive Order 12898
    J. Privacy Act
    K. Executive Order 13609 and International Trade Analysis
    L. Executive Order 13211

I. Executive Summary

    The safe transport of lithium batteries by air has been an ongoing 
concern due to the unique challenges they pose to safety in the air 
transportation environment. Unlike most other hazardous materials, 
lithium batteries have a dual hazard of chemical and electrical. This 
combination of hazards, when involved in a fire, has the potential to 
create a scenario that exceeds the fire suppression capability of an 
aircraft and lead to a catastrophic failure of the aircraft.
    The Pipeline and Hazardous Materials Safety Administration (PHMSA) 
issued an interim final rule (IFR) \1\ to amend the hazardous materials 
regulations (HMR; 49 CFR parts 171-180) to (1) prohibit the transport 
of lithium ion cells and batteries as cargo on passenger aircraft; (2) 
require all lithium ion cells and batteries to be shipped at not more 
than a 30 percent state of charge (SOC) on cargo-only aircraft; and (3) 
limit the use of alternative provisions for smaller lithium cells or 
batteries to one package per consignment. The IFR amendments 
predominately affected air carriers (both passenger and cargo-only) and 
shippers that offer lithium ion cells and batteries for transport as 
cargo by aircraft. The IFR amendments neither restricted passengers or 
crew members from bringing electronic devices containing lithium cells 
or batteries aboard aircraft nor restricted the air transport of 
lithium ion cells or batteries when packed with or contained in 
equipment. The IFR also fulfilled the section 333 mandates in the 
Federal Aviation Administration (FAA) Reauthorization Act of 2018 and 
amended the HMR to allow shipments of not more than two replacement 
lithium cells or batteries specifically used for medical devices as 
cargo on passenger aircraft--with the approval of the Associate 
Administrator--to accommodate persons in areas potentially not serviced 
daily by cargo aircraft. Furthermore, these lithium batteries may be 
excepted from the SOC requirements when they meet certain provisions.
---------------------------------------------------------------------------

    \1\ 84 FR 8006 (Mar. 6, 2019).
---------------------------------------------------------------------------

    As discussed in further detail in this final rule (see IV. Section-
by-Section Review), PHMSA amends certain sections of the HMR in 
response to public comments received to the IFR. Overall, the comments 
to the IFR were supportive of PHMSA's action; however, PHMSA did 
receive a few comments seeking further clarification or revisions to 
the IFR which PHMSA also addresses in this final rule. Specifically, 
PHMSA revises the HMR to better ensure that it reflects the original 
intent of the IFR, particularly in the alignment with the lithium 
battery transportation requirements with the International Civil 
Aviation Organization (ICAO) Technical Instructions for the Safe 
Transportation of Dangerous Goods by Air (Technical Instructions). In 
addition, PHMSA clarifies the implementation of the exception, with 
approval of the Associate Administrator, for air transportation of 
lithium batteries intended for use in medical devices. Finally, PHMSA 
responds to comments related to the marking requirement for smaller 
lithium ion cells or batteries

[[Page 77996]]

transported by modes other than aircraft and addresses a safety risk 
associated with lithium batteries transported in overpacks.
    A final regulatory impact analysis (RIA) is included in the docket 
for this rulemaking and supports the amendments made in this 
rulemaking. PHMSA examined the benefits and costs of PHMSA action in 
this rulemaking using the final rule as a baseline as shown in Table 1 
below.

                           Table 1--Summary of Incremental Costs and Benefits for Lithium Battery Provisions From the Baseline
--------------------------------------------------------------------------------------------------------------------------------------------------------
                     Provision                                Benefits                Unquantified costs             10-Year quantified cost  (7%)
--------------------------------------------------------------------------------------------------------------------------------------------------------
State of Charge...................................  None.......................  None.......................  N/A.
Consignment Limit.................................  None.......................  None.......................  N/A.
Lithium Battery Prohibition as Cargo on Passenger   None.......................  None.......................  N/A.
 Aircraft.
Marking overpacks with statement of prohibition     None.......................  None.......................  $1,574,680.
 from transport aboard passenger aircraft or a CAO
 label *.
                                                                                                             -------------------------------------------
    Total.........................................  ...........................  ...........................  10-Year: $1,574,680.
                                                                                                              Annualized: $224,199.
--------------------------------------------------------------------------------------------------------------------------------------------------------
* PHMSA's baseline assumes compliance with the IFR, including marking requirements. PHMSA did not previously quantify the costs and benefits of the
  requirement for packages shipped via all modes except air to be marked with a statement of prohibition from transportation on passenger aircraft or a
  CAO label. Thus, PHMSA quantifies the costs associated with this requirement and attributes them to the IFR and not the final rule (see Appendix I:
  Methodology for Estimating Lithium Battery Shipments). There are no quantifiable benefits associated with this requirement. PHMSA expects that the
  requirement will ensure regulatory consistency. Further, the communication is necessary to ensure safe transportation, as it will prevent smaller
  lithium cells and batteries, including those packed with or contained in equipment greater than 5 kg, from being transported as cargo on passenger
  aircraft.

    PHMSA estimates the present value of costs at about $1.6 million 
over 10 years and about $0.2 million annualized (at a 7 percent 
discount rate).
    PHMSA expects adoption of these amendments will improve the safety 
of shipments of lithium batteries, which are expected to increase as 
the use of lithium batteries in the transportation sector and other 
economic sectors increases in the years ahead. The final rule also 
provides regulatory consistency and harmonization with international 
standards, which reduces delays and interruptions in the global 
transportation of lithium batteries.

II. Background

    PHMSA issued an IFR to amend the HMR) to (1) prohibit the transport 
of lithium ion cells and batteries as cargo on passenger aircraft; (2) 
require all lithium ion cells and batteries to be shipped at not more 
than a 30 percent state of charge (SOC) on cargo-only aircraft; and (3) 
limit the use of alternative provisions for smaller lithium cells or 
batteries to one package per consignment. The IFR amendments 
predominately affected air carriers (both passenger and cargo-only) and 
shippers that offer lithium ion cells and batteries for transport as 
cargo by aircraft. The IFR amendments did not affect requirements for 
passenger and crew personal items containing lithium cells or batteries 
aboard aircraft, nor restricted the air transport of lithium ion cells 
or batteries when packed with or contained in equipment. The IFR 
fulfilled the section 333 requirement in the FAA Reauthorization Act of 
2018 to allow shipments of not more than two replacement lithium cells 
or batteries specifically used for medical devices as cargo on 
passenger aircraft--with the approval of the Associate Administrator--
to accommodate persons in areas potentially not serviced daily by cargo 
aircraft. Furthermore, these lithium batteries may be excepted from the 
SOC requirements when they meet certain provisions. See ``Section II. 
Comment Discussion; Exception for Medical Devices'' for further 
discussion.
    The IFR was necessary to address an immediate safety hazard and 
meet a statutory requirement to harmonize the HMR with emergency 
amendments to the 2015-2016 edition of the ICAO Technical Instructions. 
The serious public safety hazards associated with lithium battery 
transportation and the statutory deadline in the FAA Reauthorization 
Act of 2018 necessitated the immediate adoption of these standards in 
accordance with the APA. 5 U.S.C. 553(b)(3)(B) and 553(d)(3). The 
potential for a catastrophic loss of an aircraft, especially a 
passenger aircraft carrying lithium battery cargo, the need for 
harmonization of the HMR with emergency amendments to the ICAO 
Technical Instructions, and the statutory deadline in the FAA 
Reauthorization Act of 2018 \2\ provided compelling justification to 
adopt these changes into the HMR immediately without prior notice and 
comment.
---------------------------------------------------------------------------

    \2\ PHMSA's finding of good cause was based on the 
impracticability of providing the public with notice-and-comment 
while attempting to comply with the 90-day statutory rulemaking 
mandate in the FAA Reauthorization Act of 2018, Public Law 115-254 
(October 5, 2018, FAA Reauthorization Act of 2018). PHMSA's 
compliance with the statutory deadline was negatively impacted by a 
lapse in funding from December 22, 2018, through January 25, 2019, 
that affected PHMSA, FAA, and other government agencies.
---------------------------------------------------------------------------

    The IFR, including the APA good cause determination, was supported 
by the findings of lithium battery research conducted by the FAA's 
William J. Hughes Technical Center (FAA Technical Center), the National 
Transportation Safety Board (NTSB), and several other well-respected 
academic sources on lithium batteries and their hazards with respect to 
amendments that were adopted. The FAA Technical Center's research found 
that lithium batteries subject to certain conditions could result in 
adverse events, such as smoke and fire, that could impair the safe 
operation of the aircraft. Specifically, they found that in a lithium 
battery fire, flammable gases could collect, ignite, and ultimately 
exceed the capabilities of an aircraft's fire suppression system. See 
``Section III. Need for the Rule'' of the IFR for further explanation 
of the testing and research that supports this finding. The ICAO also 
recognized these dangers and adopted additional measures into the 
international air transport standards, which went into effect on April 
1, 2016. The potential for a catastrophic loss of an aircraft, 
especially a passenger aircraft carrying lithium battery cargo, the 
need for harmonization of the HMR with emergency amendments to the ICAO 
Technical Instructions, and the statutory deadline in the FAA 
Reauthorization Act of 2018 provided compelling justification to adopt 
these changes into the HMR immediately without prior notice and 
comment.
    In this final rule, PHMSA responds to public comments received to 
the IFR and revises the HMR based on those

[[Page 77997]]

comments. Specifically, PHMSA revises the HMR to better align the 
lithium battery transportation requirements with the ICAO Technical 
Instructions. In addition, PHMSA clarifies the implementation of the 
exception, with approval of the Associate Administrator, for lithium 
batteries intended for use in medical devices. PHMSA also responds to 
comments related to the marking requirement for smaller lithium ion 
cells or batteries transported by modes other than aircraft.

III. IFR Comment Discussion

    In response to the March 6, 2019, IFR, PHMSA received comments from 
the following organizations and individuals, which are listed in order 
of docket submission:

 Linda Seubert (PHMSA-2016-0014-0005 and -0006)
 Kevin McAuley (PHMSA-2016-0014-0007)
 The Rechargeable Battery Association (PRBA) (PHMSA-2016-0014-
0010 and -0028)
 Anonymous (PHMSA-2016-0014-0012)
 Joel Gregier (PHMSA-2016-0014-0014 and -0015)
 Medical Device Battery Transport Council (MDBTC) (PHMSA-2016-
0014-0016) \3\
---------------------------------------------------------------------------

    \3\ Since submitting comments to the IFR, the Medical Device 
Battery Transport Council has changed their name to the Medical 
Device Transport Council.
---------------------------------------------------------------------------

 Infotrac (PHMSA-2016-0014-0017)
 Sandra Harding (PHMSA-2016-0014-0018)
 Michael Stoddard (PHMSA-2016-0014-0019)
 Anonymous (PHMSA-2016-0014-0020)
 Taylor Cu (PHMSA-2016-0014-0021)
 Justin Davis (PHMSA-2016-0014-0022)
 Logistics Supply Chain Coalition (LSCC) (PHMSA-2016-0014-0023)
 Anonymous (PHMSA-2016-0014-0024)
 United Airlines (PHMSA-2016-0014-0025)
 Council on Safe Transportation of Hazardous Articles, Inc. 
(COSTHA) (PHMSA-2016-0014-0026)
 Retail Industry Leaders Association (RILA) (PHMSA-2016-0014-
0027)
 United Parcel Service (UPS) (PHMSA-2016-0014-0029)
 Air Line Pilots Association, International (ALPA) (PHMSA-2016-
0014-0030)
 Alaska Air Carriers Association (AACA) (PHMSA-2016-0014-0031)

    Below, PHMSA addresses comments to the IFR, including a brief 
synopsis and response. Additional comments are discussed in ``Section 
III. Section-by-Section Review.'' Those comments not addressed herein 
were considered beyond the scope of the rulemaking.

A. Harmonization With International Standards

    The IFR intended to align the HMR with international air transport 
standards for the transportation of lithium cells and batteries, as 
mandated in the FAA Reauthorization Act of 2018, specifically to (1) 
prohibit the transport of lithium ion cells and batteries as cargo on 
passenger aircraft; (2) require all lithium ion cells and batteries to 
be shipped at not more than a 30 percent SOC on cargo-only aircraft; 
and (3) limit the use of alternative provisions for smaller lithium 
cells or batteries to one package per consignment.
    Commenters were generally supportive of this rulemaking. Out of 23 
comments received (one duplicate), 15 commenters expressed general 
support, three (3) expressed opposition based on certain provisions, 
and the remainder sought amendment of certain provisions to improve 
clarity or avoid unintended consequences. Specifically, commenters 
supported the rulemaking's alignment with international standards and 
acknowledged the potential risk that lithium ion cells and batteries 
pose in passenger and cargo aircraft transportation.

B. Marking Requirements for Transport Modes Other Than Aircraft

    The IFR prohibited the transportation of lithium ion cells and 
batteries as cargo on passenger aircraft. Prior to publication of the 
IFR, only lithium metal cells and batteries were prohibited from 
transportation as cargo on passenger aircraft. For smaller lithium 
metal cells and batteries, the HMR required that these packages display 
a statement of prohibition or the cargo aircraft only (CAO) label, 
regardless of the mode of transportation. Because the IFR expanded the 
passenger aircraft transportation prohibition to include lithium ion 
cells and batteries, PHMSA also expanded the smaller lithium metal cell 
and battery marking or labeling requirement to include smaller lithium 
ion cells or batteries. PHMSA expected that the expansion of the hazard 
communication requirement would help to ensure that smaller lithium ion 
cells and batteries would not be accidentally transported as cargo on 
passenger aircraft. PHMSA notes that internationally--i.e., under the 
2015-2016 ICAO Technical Instructions, and later editions--lithium ion 
battery packages are required to be labeled with the CAO label. See 
ICAO Technical Instructions Packing Instruction 965.
    PHMSA received several comments that opposed this requirement, 
particularly when the package of smaller lithium ion cells and 
batteries is transported by a mode other than aircraft (e.g., highway, 
rail, and/or vessel), citing additional transport burden and costs. 
While PHMSA acknowledges the additional burden, if there is no 
indication on the package that the package is forbidden for transport 
aboard passenger aircraft, there is a higher likelihood that these 
packages will be placed on a passenger aircraft. Although packages 
shipped by highway, rail, and/or vessel may be part of a closed 
transportation system, a package of smaller lithium ion cells or 
batteries that is only marked with the lithium battery mark--without an 
indication that it is forbidden for passenger aircraft--could still 
find its way into the air transportation stream. For example, recent 
FAA data shows that there have been approximately 306 reported 
incidents where lithium cells and batteries forbidden aboard passenger 
aircraft have been transported aboard passenger aircraft. As discussed 
in the IFR, based on past incidents and the inherent potential danger 
of lithium ion battery thermal runaway events, there is a safety reason 
to reduce the likelihood that lithium ion batteries are placed on 
passenger aircraft as cargo. Therefore, PHMSA and FAA expect that the 
marking, which serves as a clear visual indication that the package is 
forbidden for transport on passenger aircraft, will help prevent air 
operator workers from inadvertently loading lithium ion battery 
packages as cargo on passenger aircraft. Because of this safety 
concern, PHMSA opted to maintain the requirement that packages of 
smaller lithium ion cells and batteries must be marked with an 
indication that the package is forbidden for transport aboard passenger 
aircraft or labeled with the CAO label. However, to communicate fully 
the burdens associated with this requirement, PHMSA quantified the 
costs attributable to the IFR in Appendix 11 of the final RIA.
    PHMSA also received suggestions for potential exceptions from the 
forbidden for passenger air mark or CAO label requirement for packages 
of smaller lithium cells and batteries. For example, COSTHA, PRBA, 
Alaska Air Carriers Association, RILA and other commenters recommended 
that PHMSA provide an exception from this mark or label requirement for 
packages of smaller lithium ion cells and batteries transported only by 
highway on

[[Page 77998]]

dedicated trucks (i.e., a private fleet) that are not transferred 
between motor carriers. PHMSA acknowledges that there may be some 
circumstances where the potential for packages to be placed on 
passenger aircraft is minimized considerably, however, no exceptions 
are adopted. As mentioned previously, it is vital to ensure that 
lithium ion cells and batteries are not placed on a passenger aircraft 
as cargo in the interest of safe transportation. Additionally, as there 
are no exceptions from this marking or labeling requirement for smaller 
lithium metal cells and batteries, the addition of an exception for 
only lithium ion cells and batteries will create an inconsistency in 
the application of the HMR and may result in uncertainties when 
complying with the HMR lithium battery requirements. The availability 
of the special permit program allows a person to present its case via 
application for an exemption from the mark or label requirement in 
accordance with 49 CFR part 107, subpart B. This process of issuing a 
special permit on a case-by-case basis allows PHMSA to maintain 
oversight by way of specific, tailored operational and safety controls 
that will prevent lithium ion batteries from being transported on 
passenger aircraft. For example, PHMSA has issued two special permits 
\4\ that exempt the Sec.  173.185(c)(1)(iii) marking or labeling 
requirements, subject to certain operational or safety controls. The 
special permits were granted to Amazon.com, Inc. and Inmar Supply Chain 
Solutions, LLC. The operational and safety controls included modal 
restrictions to highway and rail. The special permits also authorized 
the transportation of lithium batteries to designated locations only 
and required markings on overpacks such as ``OVERPACK,'' special permit 
number, the words ``Packages must remain within this overpack during 
transport,'' and the words ``LITHIUM BATTERIES--FORBIDDEN FOR TRANSPORT 
ABOARD AIRCRAFT AND VESSEL.'' These special permit operational and 
safety controls demonstrated equivalent levels of safety while 
providing relief from certain HMR requirements while also requiring 
package marking to ensure lithium battery packagings are not 
unintentionally placed as cargo on passenger aircraft.
---------------------------------------------------------------------------

    \4\ See DOT Special Permits 16413 and 20480.
---------------------------------------------------------------------------

    Commenters also noted that PHMSA did not revise the sections of the 
HMR associated with authorization and use of international standards 
and regulations (i.e., Sec. Sec.  171.12 (North American shipments), 
171.24 (additional requirements for use of the ICAO Technical 
instructions), and 171.25 (additional requirements for use of the 
International Maritime Dangerous Goods (IMDG) Code)) to mirror the 
changes made in Sec.  173.185. Specifically, commenters noted that 
Sec. Sec.  171.12 and 171.24 did not include the restriction of lithium 
ion cells and batteries from transportation on passenger aircraft and 
Sec. Sec.  171.12, 171.24, and 171.25 did not include the additional 
marking or labeling requirement for smaller lithium ion cells and 
batteries, as currently specified for smaller lithium metal cells and 
batteries. Additionally, COSTHA, Infotrac, MDBTC, PRBA, and Ms. Sandra 
Harding commented that the smaller lithium ion cell and battery 
requirement did not align with the IMDG Code or Transport Canada's 
Transportation of Dangerous Goods (TDG) Regulations and requested 
clarification on how the mark or label requirement for smaller lithium 
ion cells and batteries applies to international shipments. While PHMSA 
acknowledges that the marking requirement differs, as previously 
mentioned, PHMSA expects that the requirement will increase the safe 
transportation of lithium batteries. Furthermore, Part 5;2.4.1.3 of the 
ICAO Technical Instructions allows for markings required by other 
international or national transport regulations in addition to marks 
required by the ICAO Technical Instructions, provided they are not 
confused with or conflict with any ICAO prescribed markings.
    The absence of the conforming regulatory language for the passenger 
aircraft restriction and smaller lithium ion cell and battery mark or 
label requirement was an unintentional omission and PHMSA thanks 
commenters for bringing it to PHMSA's attention. Therefore, PHMSA adds 
language to Sec. Sec.  171.12 and 171.24 to specify that lithium ion 
cells and batteries are forbidden from transportation as cargo on 
passenger aircraft. Additionally, PHMSA adds language to Sec. Sec.  
171.12, 171.24, and 171.25 to indicate that smaller lithium ion cells 
and batteries must be marked with an indication that the package is 
forbidden for transport aboard passenger aircraft or be labeled with a 
CAO label. See ``Section IV. Section-by-Section Review; Section 
171.12,'' ``Section IV. Section-by-Section Review; Section 171.24,'' 
and ``Section IV. Section-by-Section Review; Section 171.25'' for a 
further discussion on these changes.
    Commenters also suggested that PHMSA provide an additional text 
marking option for smaller lithium cells and batteries without 
specifically indicating the battery chemistry (i.e., ``LITHIUM 
BATTERIES--FORBIDDEN FOR PASSENGER AIRCRAFT'') as lithium battery 
chemistry (i.e., ion vs. metal) no longer differentiates whether the 
package may be offered for transportation as cargo on passenger 
aircraft. PHMSA agrees that this additional option provides greater 
flexibility, without a reduction in safety. Specifically, this also 
allows shippers to use preprinted packaging and avoids the need for 
separate markings if both smaller lithium ion and metal cells and 
batteries are shipped in the same package. Therefore, PHMSA adds the 
additional marking option of a general lithium battery indication to 
Sec.  173.185(c)(3)(iii) as well as Sec. Sec.  171.24(d)(1)(ii) and 
171.25(b)(3).
    Lastly, RILA requested clarification that when the Sec.  
173.185(c)(1)(iv) marking is applied to a shipment (i.e., a package) of 
intermediate-sized lithium cells or batteries, the mark or label in 
Sec.  173.185(c)(1)(iii) is not also required to be displayed. PHMSA 
did not intend for the mark or label required by Sec.  
173.185(c)(1)(iii) to also apply to packages of lithium batteries 
marked as specified in Sec.  173.185(c)(1)(iv). Section 
173.185(c)(1)(iv) authorizes that when transported only by highway or 
rail the lithium content limitation in Sec.  173.185(c)(1)(ii) may be 
increased to 5 g for a lithium metal cell or 25 g for a lithium metal 
battery and the watt-hour (Wh) rating limitation in Sec.  
173.185(c)(1)(i) may be increased to 60 Wh for a lithium ion cell or 
300 Wh for a lithium ion battery. This allowance is authorized 
contingent on the outer package being marked: ``LITHIUM BATTERIES--
FORBIDDEN FOR TRANSPORT ABOARD AIRCRAFT AND VESSEL.'' Because this 
outer package marking provides an indication that the lithium batteries 
may not be transported by aircraft or vessel, the marking in Sec.  
173.185(c)(1)(iii), which indicates that the package is forbidden for 
passenger aircraft, would be redundant and the CAO label option would 
be confusing because the authorize increase in lithium content is not 
allowed for aircraft transportation (both passenger and cargo). To 
ensure that there is no confusion, PHMSA adds an indication in Sec.  
173.185(c)(1)(iv) to specify that a shipment of lithium cells and 
batteries marked with the forbidden for transport aboard aircraft and 
vessel statement does not need to display the marking required in Sec.  
173.185(c)(1)(iii).

[[Page 77999]]

C. Compliance Date

    PHMSA received five comments that PHMSA delay the compliance date 
\5\ for the marking or labeling requirement in Sec.  173.185(c)(1)(iii) 
for modes other than aircraft, including requests to issue a Statement 
of Enforcement Discretion. One of these comments was submitted as a 
direct letter to the Department of Transportation (DOT) by PRBA, MDBTC, 
Dangerous Goods Advisory Council (DGAC), Power Tool Institute, National 
Electrical Manufacturers Association, Outdoor Power Equipment 
Institute, and International Vessel Operators Dangerous Goods 
Association.\6\ PHMSA issued a response to this request on April 4, 
2019, in which PHMSA specified that a transition period was not 
provided and a Statement of Enforcement Discretion would not be 
issued.\7\ PHMSA explained that this marking or labeling requirement is 
essential to ensure smaller lithium ion cells and batteries are not 
inadvertently transported as cargo by passenger aircraft consistent 
with the prohibition of the carriage of lithium metal batteries as 
cargo on passenger aircraft and thus, no transition period is provided 
(i.e., no delay in compliance date).
---------------------------------------------------------------------------

    \5\ The IFR became effective March 6, 2019. PHMSA received 
comments with requests for extending the compliance date between 
four months (i.e., July 1, 2019) and twenty-one months (i.e., 
December 31, 2020).
    \6\ https://www.regulations.gov/document?D=PHMSA-2016-0014-0010.
    \7\ https://www.regulations.gov/document?D=PHMSA-2016-0014-0032.
---------------------------------------------------------------------------

    PHMSA also received an anonymous comment that PHMSA provide a 
transition period for the entire rulemaking. The commenter stated that 
a transition period would assist with rerouting of shipments where a 
cargo aircraft option does not exist and allow for proper notification 
of potential delays to customers. While PHMSA acknowledges that the 
immediate compliance of the IFR may have placed some burden on 
scheduling and potential delays, immediate compliance ensured continued 
safety for air transportation as the risks posed by lithium batteries 
on an aircraft were promptly minimized.

D. Allowance of CAO Label for Modes Other Than Aircraft

    As previously mentioned, Sec.  173.185(c)(1)(iii) provides a 
variety of methods to identify that a package is forbidden for 
transportation by passenger aircraft, which includes use of the CAO 
label. PRBA, COSTHA, RILA and some anonymous commenters noted that the 
use of the CAO label should not be authorized when the package is not 
properly prepared for cargo aircraft (i.e., lithium ion batteries 
shipped above a 30 percent SOC and not contained in or packed with 
equipment), as the CAO label is an indication that the package is 
permitted on cargo aircraft. PHMSA disagrees with the commenters' 
understanding. The intent of the CAO label is only to provide an 
indication that the package is forbidden for passenger aircraft. It 
does not indicate that the package is authorized or has been properly 
prepared for transport on cargo aircraft. Instead, the CAO label 
represents that the hazard of the contents of the package are too great 
of a risk for transportation in passenger aircraft. This is articulated 
by the message on the CAO label, which states ``FORBIDDEN IN PASSENGER 
AIRCRAFT.'' Therefore, PHMSA maintains that this label can still be 
used as an appropriate indication that the package of smaller lithium 
ion cells or batteries is forbidden for transportation aboard passenger 
aircraft, even if, for example, the batteries do not meet the SOC 
requirement for transport of lithium ion batteries aboard cargo 
aircraft.

E. Exception for Medical Devices

    In addition to instructing DOT to harmonize lithium battery 
regulations with the ICAO Technical Instructions, the FAA 
Reauthorization Act of 2018 instructed DOT to issue limited exceptions 
to the restrictions on transportation of lithium ion and metal cells 
and batteries specifically used for a medical device.\8\ PHMSA added 
paragraph (g) to Sec.  173.185 to provide limited exceptions for the 
air transportation of medical device batteries, with the approval of 
the Associate Administrator. PRBA, MDBTC, and AACA all submitted 
comments related to the regulatory text in paragraph (g).
---------------------------------------------------------------------------

    \8\ Public Law 115-254, 333, 132 Stat. 3186, 3274.
---------------------------------------------------------------------------

    PRBA asserts that PHMSA's regulatory text is inconsistent with the 
intent of the medical device batteries mandate. Specifically, PRBA does 
not consider the approval requirement outlined in the IFR to be an 
exception to the HMR's requirements. MDBTC also asserts that the 
approval requirement does not constitute an exception, claiming that 
the legislative intent was ``to allow shipments of medical device 
batteries aboard passenger aircraft in urgent situations and for PHMSA 
to define the parameters where this exception can be used.'' AACA 
expresses support for MDBTC's comments, and further states that the 
legislative intent of the FAA Reauthorization Act of 2018 ``must 
include small and large quantities of lithium ion and lithium metal 
batteries . . . in urgent situations.'' PRBA, MDBTC, and AACA allege 
that PHMSA's approval process for medical device batteries under Sec.  
173.185(g) would fail to accommodate urgent situations where medical 
device batteries need to be shipped expeditiously, such as for patients 
that require urgent medical care. MDBTC and AACA also note that the 
timeline for the approval process--90 to 120 days--is unrealistic to 
meet real-world situations when batteries are urgently needed.
    PHMSA does not agree with the commenters' description of the 
legislative intent, and notes that there is no legislative history 
available to support the commenters' assertions. The regulatory text 
under Sec.  173.185(g) establishes a process to authorize the transport 
of medical device batteries consistent with the Act's limited 
exceptions mandate under Section 333(b)(2), and PHMSA remains confident 
that the approval process can accommodate urgent shipping needs.
    Section 333(b)(1) of the FAA Reauthorization Act of 2018 sets forth 
that DOT shall consider and either grant or deny, not later than 45 
days after receipt, an application submitted in compliance with part 
107 of title 49, Code of Federal Regulations, for special permits or 
approvals for air transportation of lithium ion cells or batteries 
specifically used by medical devices. Section 333(b)(2) directs DOT to 
``issue limited exceptions'' to the HMR ``to allow the shipment on a 
passenger aircraft of not more than two (2) replacement batteries 
specifically used for a medical device'' if certain conditions are met.
    The statutory language does not specify how PHMSA should limit 
these exceptions, and there is no legislative history available. In the 
absence of direction from Congress, PHMSA responded to these mandates 
by authorizing, contingent on the approval of the Associate 
Administrator, a limited exception of up to two (2) lithium batteries 
used for medical devices to be transported on passenger aircraft and, 
as applicable, at an SOC higher than 30 percent, when the intended 
destination of the batteries is not serviced daily by cargo aircraft. 
The approval process is subject to an expedited processing period of no 
longer than 45 days. Under this approval process up to two replacement 
lithium cells or batteries specifically used for a medical device may 
be

[[Page 78000]]

transported as cargo on a passenger aircraft, when approved by the 
Associate Administrator and provided the conditions set forth in the 
Section 333(b)(2) of the FAA Reauthorization Act of 2018 are met. PHMSA 
also adopted the definition of medical device as used in Section 
333(b)(3) of the FAA Reauthorization Act of 2018.
    Further, as discussed in the IFR preamble,\9\ even though Section 
333(b)(1) of the FAA Reauthorization Act of 2018 references lithium ion 
batteries and not lithium metal batteries, PHMSA understands the 
language to also apply to lithium metal batteries because Section 
333(b)(2) applies to both lithium ion and lithium metal batteries for 
medical devices. Therefore, all approvals requested pursuant to Sec.  
173.185 are subject to the expedited processing period of no longer 
than 45 days.
---------------------------------------------------------------------------

    \9\ 84 FR 8006 at 8019 (Mar. 6, 2019).
---------------------------------------------------------------------------

    PHMSA's regulatory text complies with the FAA Reauthorization Act 
of 2018 by: (1) adopting the Act's definition of medical device, (2) 
setting up an expedited approval process to allow the transport of 
medical devices on an urgent basis, and (3) implementing packaging 
requirements mandated in the Act to ensure the safe transportation of 
each medical device battery that is transported at a SOC greater than 
30 percent. Limiting the exception via an approval requirement allows 
PHMSA to maintain oversight of these lithium battery shipments and 
address the risks they pose in air transportation, with the aim of 
ensuring the aircraft's cargo and the aircraft's passengers arrive 
safely at their destination. To date, PHMSA has received only two 
approval applications neither of which sought exception from the SOC 
requirements. These requests were denied due to not making the case for 
how the requested transport would mitigate risks posed by a lithium 
battery heat, smoke, or fire event on a passenger aircraft. Based on 
this experience with approval applications, PHMSA maintains its 
position that approval oversight is needed.
    Additionally, AACA and MDBTC assert that PHMSA's approval process 
needs to be clarified, including whether each shipment of medical 
device batteries would require approval. PHMSA understands this 
viewpoint and provides clarity as follows. When an applicant applies 
for any PHMSA approval--including this type of medical device batteries 
approval--they may choose to request an approval for a one-time 
shipment or for recurring shipments, on either a periodic or as needed 
basis. See 49 CFR 107.705(b)(2). Specific to recurring shipments, PHMSA 
expects that issuing this type of approval will accommodate emergency 
circumstances because a person who wishes to offer or transport lithium 
batteries for medical devices will have prior approval before the 
emergency need occurs.
    MDBTC also commented that the expedited approval process should be 
codified in part 107. PHMSA agrees that the unique procedures for 
lithium cells and batteries for medical devices in Sec.  173.185(g) 
should be included in part 107. PHMSA revises Sec. Sec.  107.709(b) and 
(f) to reflect the expedited application process found in the FAA 
Reauthorization Act of 2018. See ``Section IV. Section-by-Section 
Review; Section 107.709'' for further detail on the specific revisions 
to these paragraphs.
    Additionally, PHMSA requested comment on certain criteria for this 
provision, including potential impacts these criteria may have on 
stakeholders. The following details the criteria, along with a 
discussion of the comments PHMSA received.
     Definition of ``not more than two replacement lithium 
cells or batteries. PHMSA requested comment on whether the limitation 
that ``not more than two replacement lithium cells or batteries'' 
applies to the number of cells or batteries per package. MDBTC agreed 
the intent of Section 333(b)(2) of the 2018 FAA Reauthorization Act 
provision is two cells or batteries per package (and not per shipment 
or consignment). As this provision minimizes the number of batteries in 
each package, which reduces the potential for a thermal runaway event 
in transportation and thus increases safety, PHMSA maintains Sec.  
173.185(g) as written such that not more than two (2) lithium cells or 
batteries are allowed per package.
     Determination of destination no longer ``serviced daily by 
cargo aircraft'': PHMSA requested comment on what should be considered 
to determine when a destination is no longer ``serviced daily by a 
cargo aircraft.'' MDBTC, supported by the AACA, commented that it was 
not necessary for PHMSA to specify a specific distance to define when a 
location is no longer serviced daily by cargo aircraft. Furthermore, 
MDBTC commented that availability of the exception should be based on 
the need for urgent patient care when other means of transport are 
unavailable or inappropriate. AACA also stated that the distance should 
not be a condition of the exception. PHMSA agrees with MDBTC and AACA 
that ``serviced daily by a cargo aircraft'' should not be tied to a 
specified distance, as this will provide greater flexibility for 
handling unique transport circumstances. It is necessary for the person 
who wishes to transport the lithium cell or battery for medical devices 
to demonstrate that the location is not serviced daily by cargo 
aircraft in their application, as this is a condition for the exception 
that is articulated in Sec.  173.185(g). PHMSA is also making a 
conforming revision to add Sec.  107.705(b)(6) to specify that this 
information must be provided in the approval application.
     Definition of batteries ``required for medically necessary 
care'': PHMSA stated that batteries ``required for medically necessary 
care'' are batteries that are needed for a medical device that is used 
by the recipient for medical care and requested comment on stakeholder 
impact. MDBTC commented that the definition of ``required for medically 
necessary care'' is appropriate. PHMSA received no further comment on 
this subject. Therefore, PHMSA maintains that batteries required for 
medically necessary care in Sec.  173.185(g) means the batteries are 
needed for a medical device that is used by the recipient for medical 
care.
    MDBTC and PRBA both commented that PHMSA should harmonize the HMR 
with Special Provision A334 found in the Supplement to ICAO Technical 
Instructions for all lithium batteries. MDBTC further stated that this 
provision would expand the allowance to ship lithium batteries for 
emergency needs to remote areas in circumstances outside of medical 
device transportation. AACA was supportive of MDBTC's comments and 
further commented that allowances should be made for small quantities 
of lithium ion cells and batteries to be shipped to remote locations. 
Special Provision A334 provides guidance to competent authorities on 
exceptions for lithium cells or batteries to be transported on 
passenger aircraft when other forms of transport--including cargo 
aircraft--are impracticable. This special provision identifies specific 
quantity limits and performance test criteria that can be used to 
acquire the approval of the State of Origin, the State of the Operator, 
and the State of Destination. It is unnecessary to adopt this specific 
language as PHMSA already provides a general approval mechanism for 
lithium batteries that do not conform to the provisions of the HMR (see 
Sec.  173.185(h)). Finally, as previously mentioned, the FAA 
Reauthorization Act of 2018 required PHMSA to harmonize the HMR with 
emergency

[[Page 78001]]

amendments to the 2015-2016 edition of the ICAO TI. Special Provision 
A334 was not part of these emergency amendments to the 2015-16 edition 
but rather part of the Supplement to the ICAO TI that provides non-
binding guidance to competent authorities (e.g., State of Origin) on 
approval requirements. Therefore, PHMSA is choosing to use the non-
binding guidance offered in Special Provision A334 as part of the 
approval process already in place in Sec.  173.185(h) and not 
specifically codify the Special provision A334 non-binding guidance 
into the HMR.

F. Fire Resistant Containers and Fire Containment Covers Effectiveness

    UPS commented that the IFR preamble language ineffectively 
portrayed the effectiveness of Fire Resistant Containers (FRCs) and 
Fire Containment Covers (FCCs). Specifically, UPS stated that the FRC 
tests used preliminary container configurations and containers altered 
from the specification, and while important steps, the tests were not a 
final assessment. Furthermore, UPS commented that they have 
quantifiable data that demonstrates FRC and FCC effectiveness as 
shipping devices for lithium ion batteries, especially when it is 
combined with a multi-layered approach to safety measures.
    PHMSA appreciates this feedback from UPS and agrees that testing is 
continuously ongoing, and the current state of results is not intended 
to be an indication of the final assessment in ensuring the safe 
transportation of lithium ion batteries by aircraft. PHMSA looks 
forward to continuing to work with UPS and any other industry partners 
to better enhance safety through measures such as performance packaging 
while ensuring continued efficient operations in lithium battery 
transportation and appreciates any data that can be shared that will 
help inform decision-making.

G. Miscellaneous Comments

    PHMSA received several additional comments on various subjects, 
which are discussed as follows.
    Mr. Kevin McAuley requested clarification on whether the provisions 
of the IFR prohibited lithium batteries from being transported as cargo 
on passenger and cargo aircraft or whether the prohibition only applied 
to lithium ion batteries transported above a 30 percent SOC on cargo 
aircraft. The IFR and this final rule prohibit lithium ion cells and 
batteries from being offered as cargo on passenger aircraft (emphasis 
added). Further, regarding carriage on cargo aircraft, consistent with 
international standards, this rulemaking prohibits lithium ion cells 
and batteries from being offered as cargo on cargo aircraft above a 30 
percent SOC. Finally, when smaller lithium cells and batteries (both 
ion and metal) are offered as cargo on cargo-only aircraft, they are 
limited to one package per consignment as provided in Sec.  
173.185(c)(4)(iii).
    AACA supported an automatic approval system, particularly for 
Alaska and other states where the population is less than 25 people per 
square mile, noting that other agencies have provided special 
exemptions based on that population density. PHMSA is not implementing 
an automatic approval in response to this comment, which is not 
mandated under Sec.  333(b) of the FAA Reauthorization Act of 2018. 
However, while PHMSA has worked to streamline the approval process over 
the years, such as approval submissions being accepted via an online 
portal, PHMSA continues to look for new ways to improve this process. 
PHMSA looks forward to working with AACA and other stakeholders in the 
future to continue to identify new and improved avenues to expedite the 
approval process.
    AACA also commented on the need for additional allowances for 
shipments of larger quantities of lithium ion and metal batteries by 
aircraft, particularly to remote areas. PHMSA understands that there 
may be additional unique transport circumstances beyond the scope of 
Sec.  173.185(g). While scenarios outside of Sec.  173.185(g) are not 
identified, PHMSA can facilitate shipments of lithium batteries through 
the issuance of an approval under Sec.  173.185(h) or a special permit 
and urges those persons offering these large shipments to apply.
    An anonymous commenter requested that PHMSA add new paragraph Sec.  
173.185(a)(4), which would contain the SOC limitation (specifically, 
the commenter suggested: ``For [transport] by air only, lithium ion 
cells or batteries, [except] when they are contained in equipment, 
shall not exceed [SOC] 30%.''). PHMSA added Special Provision A100 to 
the list of special provisions in Sec.  172.102 and assigned it to the 
entry for ``UN3480, Lithium ion batteries'' in Column (7) in the Sec.  
172.101 Hazardous Materials Table (HMT). This special provision 
specifies that lithium ion cells and batteries must be offered for 
transportation at a SOC that does not exceed 30 percent of their rated 
capacity. Adding the SOC limitation to Sec.  173.185(a) is not 
necessary and would create confusion because Sec.  173.185(a)(1) 
details the classification requirements for all lithium cells or 
batteries, regardless of the United Nations (UN) Identification number, 
mode of transportation, or if shipped separately or contained in or 
packed with equipment. Furthermore, placement of the requirement in the 
HMR as a special provision is consistent with its applicability only to 
the air mode.

IV. Section-by-Section Review

    The following is a section-by-section review of the amendments 
adopted in this final rule:

Part 107

Section 107.705
    Section 107.705 details the requirements for an approval 
application. PHMSA adds paragraph (b)(6) to specify that an applicant 
applying for an approval for lithium cells and batteries for medical 
devices, as authorized in Sec.  173.185(g), must include details on the 
extent to which the destination(s) of the lithium cells and batteries 
are not serviced daily by cargo aircraft. See ``Section II.E IFR 
Comment Discussion; Exception for Medical Devices'' for additional 
discussion on this revision. In addition, PHMSA revises paragraphs 
(b)(4) and (5)(ii) editorially to account for the new paragraph.
Section 107.709
    This section includes the processing requirements for approvals. 
Paragraph (b) specifies PHMSA's process for reviewing approval 
applications, including the time frame for requesting additional 
information. Paragraph (f) specifies that PHMSA will notify the 
approval applicant in writing of the decision on the application. PHMSA 
revises paragraphs (b) and (f) to detail the expedited review process 
for Sec.  173.185(g) shipments of lithium cells and batteries 
specifically used for medical devices. PHMSA revises paragraph (b) to 
specify that there will be an expedited review. PHMSA also revises 
paragraph (f) to specify that for approvals of lithium cells and 
batteries for medical devices, as outlined in Sec.  173.185(g), the 
approvals will be either granted or denied no later than 45 days after 
receipt of a completed application. See ``Section II.E IFR Comment 
Discussion; Exception for Medical Devices'' for additional discussion 
on this revision.

Part 171

Section 171.12
    This section details the requirements for the transportation of 
hazardous

[[Page 78002]]

materials throughout North America. Specifically, paragraph (a) 
provides allowances for the shipment of hazardous materials in 
accordance with the Transport Canada TDG Regulations. Paragraph (a)(6) 
details additional requirements when lithium metal cells and batteries 
are transported in accordance with the TDG regulations. COSTHA and PRBA 
both commented that PHMSA did not revise Sec.  171.12(a)(6) to reflect 
the newly adopted provisions that lithium ion cells and batteries were 
forbidden for transportation aboard passenger aircraft. PHMSA agrees 
with the commenters as this was an unintentional omission. Therefore, 
PHMSA amends Sec.  171.12(a)(6) to add an indication that lithium ion 
cells and batteries (UN3480) are prohibited for transport as cargo 
aboard passenger aircraft.
    Additionally, PHMSA revises paragraph (a)(6) to add a reference to 
Sec.  173.185(c)(1)(vi). As discussed in ``Section III. Section-by-
Section Review; Section 173.185,'' PHMSA revises Sec.  
173.185(c)(1)(vi) to add a requirement that when a package is marked or 
labeled in accordance with Sec. Sec.  173.185(c)(1)(iii) or (iv) and is 
placed in an overpack, the selected marking or label must either be 
clearly visible through the overpack, or the marking or label must also 
be affixed on the outside of the overpack. This requirement addresses a 
hazard communication safety gap and ensures that the overpack includes 
the same hazard information as displayed on the package. Therefore, to 
ensure this requirement also applies to shipments transported in 
accordance with the TDG regulations, PHMSA adds a cross reference to 
Sec.  173.185(c)(1)(vi).
Section 171.24
    This section provides additional requirements for the use of the 
ICAO Technical Instructions. COSTHA, MDBTC, and PRBA noted that PHMSA 
did not revise Sec.  171.24(d)(1)(ii) to reflect the IFR provisions, 
specifically the prohibition of lithium ion cells and batteries from 
being transported aboard passenger aircraft and the requirement in 
Sec.  173.185(c)(1)(iii) to mark the outside of a package containing 
smaller lithium ion cells and batteries (i.e., Packaging Instruction 
965, Section II) with a mark or label that indicates the package is 
forbidden for transport aboard passenger aircraft. This was an 
unintentional omission. PHMSA agrees with the commenters and makes the 
conforming amendment in Sec.  171.24(d)(1)(ii) to reflect the 
prohibition and hazard communication requirement.
    PHMSA also received comments that PHMSA add an alternative 
forbidden for passenger aircraft marking in Sec.  173.185(c)(1)(iii) 
(i.e., ``LITHIUM BATTERIES--FORBIDDEN FOR TRANSPORT ABOARD PASSENGER 
AIRCRAFT''). Since PHMSA allows this alternative in Sec.  
173.185(c)(1)(iii), for consistency, PHMSA adds this marking 
alternative in Sec.  171.24(d)(1)(ii) to allow packages containing 
smaller lithium cells and batteries of both chemistries to be 
appropriately marked. See ``Section II.B IFR Comment Discussion; 
Marking Requirements for Transport Modes Other than Aircraft'' for 
further discussion.
    Lastly, PHMSA revises paragraph (d)(1)(ii) to specify that when a 
package that is marked or labeled with an indication that the package 
is forbidden for transport aboard passenger aircraft and is placed in 
an overpack, the selected mark or label must either be clearly visible 
through the overpack, or the marking or label must be affixed on the 
outside of the overpack. As discussed in ``Section III. Section-by-
Section Review; Section 173.185,'' PHMSA revises Sec.  
173.185(c)(1)(vi) to add this requirement to address a hazard 
communication safety gap and ensure that the overpack also communicates 
that it is forbidden for transport on passenger aircraft. Therefore, to 
ensure this requirement also applies to shipments transported in 
accordance with the ICAO Technical Instructions, PHMSA adds the same 
requirement to Sec.  171.24.
Section 171.25
    This section provides additional requirements for use of the IMDG 
Code. COSTHA, MDBTC, PRBA, Infotrac, and Ms. Sandra Harding commented 
that PHMSA did not revise Sec.  171.25(b)(3) to reflect the IFR 
provisions in Sec.  173.185(c)(1)(iii) to require a mark or label that 
indicates a package of smaller lithium ion cells or batteries 
transported in accordance with Special Provision 188 is forbidden for 
transportation on passenger aircraft. This was an unintentional 
omission. PHMSA agrees with the commenters and is making the conforming 
amendment in Sec.  171.25(b)(3) to reflect the prohibition and hazard 
communication requirement.
    PHMSA also received comments that requested PHMSA add an 
alternative forbidden for passenger aircraft marking in Sec.  
173.185(c)(1)(iii) (i.e., ``LITHIUM BATTERIES--FORBIDDEN FOR TRANSPORT 
ABOARD PASSENGER AIRCRAFT''). Since PHMSA allows this alternative in 
Sec.  173.185(c)(1)(iii), for consistency, PHMSA adds this marking 
alternative in Sec.  171.25(b)(3) to allow packages containing smaller 
lithium cells and batteries of both chemistries to be appropriately 
marked. See ``Section II.B IFR Comment Discussion; Marking Requirements 
for Transport Modes Other than Aircraft'' for further discussion.
    Lastly, PHMSA revises paragraph (b)(3) to specify that when a 
package that is marked or labeled with an indication that the package 
is forbidden for transport aboard passenger aircraft and is placed in 
an overpack, the selected mark or label must either be clearly visible 
through the overpack, or the marking or label must be affixed on the 
outside of the overpack. As discussed in ``Section III. Section-by-
Section Review; Section 173.185,'' PHMSA revises Sec.  
173.185(c)(1)(vi) to add this requirement to address a hazard 
communication safety gap and ensure that the overpack also communicates 
that it is forbidden for transport on passenger aircraft. Therefore, to 
ensure this requirement also applies to shipments transported in 
accordance with the IMDG Code, PHMSA adds the same requirement to Sec.  
171.25.

Part 172

Section 172.101
    This section outlines the HMT and instructions for its use. PHMSA 
received no comments to the amendments. The IFR amendments met the 
requirements of Section 333 of the FAA Reauthorization Act of 2018, 
harmonize with international standards, and ensure the safe 
transportation of lithium batteries. Accordingly, no changes are being 
made to Sec.  172.101.
Section 172.102
    This section lists special provisions applicable to specific 
hazardous materials, as listed in Column (7) of the Sec.  172.101 HMT. 
PHMSA received no comments to the amendments. The IFR amendments met 
the requirements of Section 333 of the FAA Reauthorization Act of 2018, 
harmonize with international standards, and ensure the safe 
transportation of lithium batteries.
    PHMSA added a new special provision A100, assigning it to ``UN3480, 
Lithium ion batteries, including lithium ion polymer batteries, 9.'' 
This new special provision, consistent with the ICAO Technical 
Instructions, requires that when lithium ion cells and batteries are 
offered for transportation by cargo aircraft, they may not be shipped 
at a SOC that exceeds 30 percent of their rated capacity. Lithium ion 
cells and batteries

[[Page 78003]]

may be offered for transportation at a SOC greater than 30 percent only 
with the approval of the Associate Administrator. This special 
provision does not apply to those lithium ion cells and batteries 
packed with or contained in equipment.
    PHMSA received an anonymous comment that requested PHMSA add the 
SOC limitation (currently specified in special provision A100) in a new 
paragraph Sec.  173.185(a)(4). It is unclear whether the commenter 
requested the removal of special provision A100 or the addition of a 
statement of the SOC limitation in Sec.  173.185(a)(4). As discussed in 
``Section II.G IFR Comment Discussion; Miscellaneous Comments,'' PHMSA 
disagrees with the commenter that it would provide further 
clarification to a shipper. Furthermore, special provision A100 aligns 
with ICAO Technical Instructions and ensures the safe transportation of 
lithium ion batteries on cargo aircraft (see ``Section V.B. State of 
Charge Requirement'' of the IFR for a more detailed discussion of the 
positive impacts to transportation at a reduced state of charge). As 
such, PHMSA maintains special provision A100 as written.

Part 173

Section 173.185
    This section prescribes the packaging requirements for the 
transportation of lithium batteries. PHMSA adopted a new definition for 
``medical device'' in the introductory paragraph, as defined in the FAA 
Reauthorization Act of 2018. As previously detailed, PHMSA adopted the 
definition of a medical device from section 333(b)(3) of the FAA 
Reauthorization Act of 2018 to mean ``an instrument, apparatus, 
implement, machine, contrivance, implant, or in vitro reagent, 
including any component, part, or accessory thereof, which is intended 
for use in the diagnosis of disease or other conditions, or in the 
cure, mitigation, treatment, or prevention of disease, of a person.'' 
PHMSA did not receive any comments related to this definition. PHMSA 
maintains that this definition provides regulatory clarity in the 
applicability of Sec.  173.185(g), which aids in increased regulatory 
compliance and thus, safety. In addition, PHMSA maintains the 
definition as defined in the FAA Reauthorization Act of 2018, and no 
changes are being made to the ``medical device'' definition.
    Section 173.185(a) details classification criteria for lithium 
cells and batteries, including the requirements for testing lithium 
batteries and documenting those test requirements. As previously 
discussed, an anonymous commenter suggested that PHMSA add a new 
paragraph (a)(4) to detail SOC limitation requirements. PHMSA disagrees 
that this new paragraph would add clarity, as the SOC limitation only 
applies to lithium ion cells and batteries transported by cargo 
aircraft (i.e., UN3480 assigned to special provision A100) and 
paragraph (a) applies to the transportation of all lithium cells and 
batteries, including those packed with and contained in equipment, by 
all modes. Therefore, no new paragraph is added to specify the lithium 
ion cell and battery SOC limitation. See ``Section III. IFR Comment 
Discussion; Miscellaneous Amendments'' for a further additional 
discussion on this comment.
    Paragraph (c) specifies exceptions for smaller lithium cells and 
batteries. Paragraph (c)(1)(iii) details requirements for marking of 
packages with an indication that they are forbidden for transport 
aboard passenger aircraft or labeling of packages with the CAO label. 
Prior to the IFR, this paragraph only applied to smaller lithium metal 
cells and batteries, except when lithium metal cells or batteries are 
packed with or contained in equipment in quantities not exceeding 5 kg 
net weight. To align with the provision restricting lithium ion cells 
and batteries from being transported on passenger aircraft, PHMSA 
revised Sec.  173.185(c)(1)(iii) to include smaller lithium ion cells 
and batteries in the requirement. PHMSA received several comments that 
requested PHMSA revise the hazard communication requirement to apply 
only to shipments of smaller lithium ion cells and batteries intended 
for transportation via aircraft, all or in part. Alternatively, 
commenters requested that PHMSA provide for a delayed compliance date 
(i.e., a transition period) for shipments of smaller lithium ion cells 
and batteries offered by modes other than aircraft as well as exercise 
enforcement discretion. Although PHMSA acknowledges this requirement is 
burdensome on persons who offer smaller lithium ion cells and batteries 
by modes other than aircraft, PHMSA determined that this hazard 
communication requirement across all modes ensures that smaller lithium 
ion cells and batteries are not accidently or unintentionally offered 
for transportation as cargo on passenger aircraft. As previously 
mentioned in the IFR, the potential for an uncontrolled fire involving 
a relatively small quantity of lithium batteries to lead to a 
catastrophic failure of the airframe, the inability of the package or 
the aircraft fire suppression system to control such a fire presents an 
unacceptable safety risk. This ultimately increases safe transportation 
as it reduces the potential for incidents involving lithium ion cells 
and batteries to occur aboard passenger aircraft. See ``Section III.B 
IFR Comment Discussion; Marking Requirements for Transport Modes Other 
than Aircraft'' and ``Section III.C IFR Comment Discussion; Compliance 
Date'' for a more detailed discussion on both issues.
    PHMSA also received comments from PRBA, Infotrac, MDBTC, COSTHA, 
RILA, and an anonymous commenter asking that PHMSA add an alternative 
text marking in Sec.  173.185(c)(1)(iii). This alternative (i.e., 
``LITHIUM BATTERIES--FORBIDDEN FOR TRANSPORT ABOARD PASSENGER 
AIRCRAFT'') does not specify lithium battery chemistry. Because both 
lithium ion and lithium metal cells and batteries are now forbidden 
from transportation as cargo on passenger aircraft, it is not necessary 
to distinguish the battery chemistry as part of the marking 
requirement. This also provides greater flexibility with marking 
options for packages containing batteries of both chemistries without 
reducing safety. PHMSA agrees with the commenters and amends Sec.  
173.185(c)(1)(iii) to include the alternative marking.
    Paragraph (c)(1)(iv) authorizes increased size limits for the 
paragraph (c) exceptions when the package is offered for highway or 
rail only and the outer package is marked with ``LITHIUM BATTERIES--
FORBIDDEN FOR TRANSPORT ABOARD AIRCRAFT AND VESSEL.'' As previously 
discussed, RILA commented about the potential confusion in whether the 
Sec.  173.185(c)(1)(iii) mark was also required when a package bears 
this Sec.  173.185(c)(1)(iv) mark. As the paragraph (c)(1)(iv) mark is 
more conservative than the paragraph (c)(1)(iii) mark or label, PHMSA 
adds language in Sec.  173.185(c)(1)(iv) to clarify that the Sec.  
173.185(c)(1)(iii) mark is not required. See ``Section II. Comment 
Discussion; Marking Requirements for Modes other than Aircraft'' for 
additional discussion on this change.
    In final rule HM-215O,\10\ PHMSA added a new paragraph (c)(3)(iii) 
to specify overpack requirements for a package displaying a lithium 
battery mark. Specifically, when those packages are placed in an 
overpack and the lithium battery mark is not visible, the mark must be 
reproduced on the overpack and be marked with the word ``OVERPACK'' at 
least 12 mm (0.47

[[Page 78004]]

inches) high. In development of this final rule, PHMSA noted that the 
HM-215O overpack requirement did not include all hazard communication 
that could potentially be displayed on a package of smaller lithium 
cells or batteries. Specifically, this requirement does not include 
requiring the hazard communication in paragraphs (c)(1)(iii) and (iv) 
(i.e., the CAO label, the paragraph (c)(1)(iii) mark, and the paragraph 
(c)(1)(iv) mark) to be visible or reproduced on an overpack. As 
previously discussed, there is a safety need to require the paragraph 
(c)(1)(iii) hazard communication on all packages of smaller lithium 
cells and batteries, even if they are not being offered for 
transportation by air. This need also applies to the paragraph 
(c)(1)(iv) mark. The requirement to reproduce the hazard communication 
on the overpack is consistent with the general overpack requirements in 
Sec.  173.25 specify that when a package is placed in an overpack, the 
proper shipping name, identification number, and labels on the package 
must be displayed on the overpack, unless they are otherwise visible. 
The overpack requirement ensures that the hazard communication that 
needs to be displayed on packages is not lost when consolidated or 
further packed in an overpack. Although not originally included, PHMSA 
determines that when a package bears the paragraph (c)(1)(iii) and (iv) 
required mark or label, and the package is placed in an overpack, those 
marks and labels should be visible or must be reproduced on the outside 
of the overpack. This is consistent with the requirements to reproduce 
the required markings and CAO label in Sec.  173.185(c)(4)(ii). To 
address this safety gap, PHMSA redesignates current paragraph 
(c)(1)(vi) to paragraph (c)(1)(vii) and adds a new paragraph (c)(1)(vi) 
to specify the overpack requirements. PHMSA expects that this new 
requirement will reduce the potential for packages of smaller lithium 
cells or batteries that have been overpacked to be placed on a 
passenger aircraft and thereby increasing safety of transportation.
---------------------------------------------------------------------------

    \10\ 85 FR 27810 (May 11, 2020).
---------------------------------------------------------------------------

    Section 173.185(c)(4)(i) details the quantity limitations for 
smaller lithium cells and batteries offered by air transportation. 
PHMSA received comments from COSTHA and an anonymous commenter that 
Sec.  173.185(c)(4)(i) could be misinterpreted to also require that the 
limitations in the paragraph apply to lithium batteries packed with or 
contained in equipment. The commenters suggested PHMSA add ``except 
when packaged with or contained in equipment'' to the text of Sec.  
173.185(c)(4)(i). PHMSA agrees with the commenters that this provides 
greater clarity and harmonizes with the ICAO Technical Instructions. 
Therefore, PHMSA amends Sec.  173.185(c)(4)(i) to reflect that these 
conditions and limitations do not apply to batteries packed with or 
contained in equipment.
    An anonymous commenter also recommended that PHMSA add a sentence 
to the end of paragraph (c)(4)(i) to indicate which paragraphs lithium 
cells and batteries packed with or contained in equipment are subject 
to. PHMSA disagrees with this suggestion and expects that such addition 
would cause additional confusion as paragraph (c)(4)(i) does not apply 
to smaller lithium cells and batteries packed with or contained in 
equipment.
    Section 173.185(c)(4)(ii) details requirements for transportation 
of smaller lithium cells and batteries in overpacks. The IFR amended 
Sec.  173.185(c)(4)(ii) to indicate that only one package of smaller 
lithium cells and batteries may be placed in an overpack, consistent 
with ICAO Technical Instructions. PRBA, COSTHA, and MDBTC commented 
that the reference to only paragraph (c)(4) makes Sec.  
173.185(c)(4)(ii) inconsistent with the ICAO Technical Instructions, as 
lithium cells and batteries packed with or contained in equipment are 
not limited to one package per overpack. The commenters suggested PHMSA 
amend the section to instead reference paragraph (c)(4)(i) to 
distinguish that the requirement only applies to smaller lithium cells 
and batteries. PHMSA agrees, this was an error. Therefore, PHMSA 
revises the reference to indicate the requirement only applies to those 
packages prepared in accordance with Sec.  173.185(c)(4)(i). 
Furthermore, an anonymous commenter suggested PHMSA delete the 
requirement completely from the paragraph. The commenter did not 
specify the reason for removing this requirement. As this provision 
increases the safe transportation of lithium batteries by air and meets 
the intent of this rulemaking to align the HMR with ICAO Technical 
Instructions, PHMSA will not remove the requirement in paragraph 
(c)(4)(i).
    PHMSA expanded the overpack marking requirement in Sec.  
173.185(c)(4)(ii) to require that when a package displays the paragraph 
(c)(1)(iii) required mark or label and is placed in an overpack, the 
mark or label must be reproduced if not visible through the overpack. 
However, as previously discussed, in Sec.  173.185(c)(1)(vi), PHMSA 
adds a requirement that when a package displays the paragraph 
(c)(1)(iii) required mark or label (as well as the paragraph (c)(1)(iv) 
mark) and is placed in an overpack, the mark or label must be visible 
or reproduced on overpack. This applies to all modes of transportation 
and not just air. Additionally, in the HM-215O final rule, PHMSA added 
Sec.  173.185(c)(3)(iii) to require that for all modes of 
transportation, when a package displays the lithium battery mark and is 
placed in an overpack, the mark must be visible or reproduced on the 
overpack along with the word ``OVERPACK.'' As both of these 
requirements apply to all modes of transportation, including air, the 
second and third sentence of paragraph (c)(4)(ii) are now duplicative. 
Therefore, PHMSA removes the duplicative requirement in the second and 
third sentence of paragraph (c)(4)(ii) to eliminate any potential 
regulatory confusion and increase regulatory compliance.
    PHMSA added Sec.  173.185(c)(4)(iii) to specify that a shipper is 
not permitted to offer more than one package of smaller lithium cells 
and batteries in any single consignment by aircraft. PHMSA maintains 
that this requirement aligns the HMR with the ICAO Technical 
Instructions and increases safety. However, PRBA, COSTHA, MDBTC, and an 
anonymous commenter noted that the amendments may have unintentionally 
subjected smaller lithium cells and batteries contained in or packed 
with equipment to this requirement. PHMSA did not intend the limitation 
to apply to smaller lithium cells and batteries contained in or packed 
with equipment, and therefore amends Sec.  173.185(c)(4)(iii) to state 
that the limitation of one package in any single consignment is only 
for those packages prepared in accordance with the provisions of 
paragraph (c)(4)(i).
    PHMSA added paragraph (c)(4)(v) to indicate that packages and 
overpacks of smaller lithium cells and batteries must be offered 
separately from cargo not subject to the HMR and must not be loaded 
into a unit load device before being offered to the operator. This 
paragraph harmonizes with ICAO Technical Instructions and increases 
safety. PHMSA received comments from PRBA, COSTHA, MDBTC, and an 
anonymous commenter to revise the reference from ``prepared in 
accordance with paragraph (c)(4)'' to ``prepared in accordance with 
paragraph (c)(4)(i)'' to ensure that this requirement does not apply to 
smaller lithium cells and batteries packed with or contained in 
equipment. PHMSA agrees and did not intend to require that smaller 
lithium cells and batteries packed with or

[[Page 78005]]

contained in equipment be subject to this requirement. Therefore, PHMSA 
revises the reference to read as paragraph (c)(4)(i).
    To account for redesignated paragraph (c)(1)(iv) and new paragraph 
(c)(1)(v), PHMSA redesignated paragraph (c)(4)(iv) to paragraph 
(c)(4)(vi). This paragraph details quantity limitations for smaller 
lithium cells and batteries packed with or contained in equipment. 
MDBTC commented that PHMSA should revise this paragraph to specify 
``spare sets'' instead of ``spares'' to harmonize more accurately with 
the ICAO Technical Instructions. PHMSA agrees and this revision was 
already made in the HM-215O final rule. Therefore, no revisions to this 
paragraph are needed.
    To account for new paragraph (c)(4)(v) and redesignated paragraph 
(c)(4)(vi), PHMSA redesignated paragraph (c)(4)(v) as paragraph 
(c)(4)(vii). PHMSA received no comments to this paragraph and there are 
no revisions to this paragraph.
    Following publication of the IFR, PHMSA added paragraph 
(c)(4)(viii) in the HM-215O final rule to specify that for air 
transport, smaller lithium cells and batteries may not be placed in the 
same package as other hazardous materials. Furthermore, packages that 
contain smaller lithium cells and batteries must not be placed into an 
overpack with packages that contain materials of Class 1 (explosives) 
other than Division 1.4S, Division 2.1 (flammable gases), Class 3 
(flammable liquids), Division 4.1 (flammable solids) or Division 5.1 
(oxidizers). Upon review, PHMSA identified that paragraph (c)(4)(viii) 
inadvertently referenced packages prepared in accordance with paragraph 
(c)(4) and not paragraph (c)(4)(i). PHMSA intended that this 
requirement apply only to packagings of smaller lithium cells and 
batteries shipped by air, and not those packed with or contained in 
equipment. Therefore, in Sec.  173.185(c)(4)(viii), PHMSA revises the 
reference of paragraph (c)(4) to paragraph (c)(4)(i) as a correcting 
and editorial amendment.
    PHMSA added paragraph (c)(5), using text from former paragraph 
(c)(4)(vi). This paragraph provides minimal exceptions when the number 
or quantity (mass) limits in the paragraph (c)(4)(i) table, the 
overpack limit described in paragraph (c)(4)(ii), or the consignment 
limit in paragraph (c)(4)(iii) is exceeded, but the lithium cells and 
batteries are still below the size limitations in paragraph (c)(3). 
PHMSA received an anonymous comment requesting that PHMSA remove the 
applicability of paragraph (c)(5) to packages that exceed the overpack 
limit described in paragraph (c)(4)(ii). The commenter did not provide 
further details to their request for this revision.
    If removed, PHMSA would no longer authorize an alternative to 
limited exceptions when the limitation of one package of lithium cells 
or batteries per overpack is exceeded. In addition, this would make the 
regulatory provision inconsistent with the ICAO Technical Instructions, 
which would decrease consistency and thus, decrease compliance. 
Therefore, PHMSA does not remove this exception.
    Lastly, PHMSA added a new paragraph (g) in the IFR to meet the 
mandate in the FAA Reauthorization Act of 2018. This new paragraph 
authorizes, with the approval of the Associate Administrator, an 
exception for up to two lithium batteries used for medical devices to 
be transported on passenger aircraft and, as applicable, at a SOC 
greater than 30 percent, when the intended destination of the batteries 
is not serviced daily by cargo aircraft. PHMSA received comments from 
PRBA, MDBTC, and AACA on this new paragraph. As discussed in ``Section 
II.E Comment Discussion; Exception for Medical Devices,'' no revisions 
to this paragraph are made.

V. Regulatory Analysis and Notices

A. Statutory/Legal Authority

    This final rule is published under the authority of the Federal 
Hazardous Materials Transportation Act (HMTA; 49 U.S.C. 5101-5127). 
Section 5103(b) of the HMTA authorizes the Secretary of Transportation 
to ``prescribe regulations for the safe transportation, including 
security, of hazardous material in intrastate, interstate, and foreign 
commerce.'' The Secretary has delegated the authority granted in the 
HMTA to the PHMSA Administrator at 49 CFR 1.97(b). Lithium cells and 
batteries are designated as hazardous materials under 49 U.S.C. 
5103(a).\11\ This final rule revises regulations for the safe transport 
of lithium cells and batteries by air and the protection of aircraft 
operators and the flying public.
---------------------------------------------------------------------------

    \11\ Hazardous materials table entries added for lithium 
batteries in a December 21, 1990 final rule [55 FR 52402].
---------------------------------------------------------------------------

B. Executive Order 12866 and DOT Regulatory Policies and Procedures

    Executive Order 12866 (``Regulatory Planning and Review'') \12\ 
recommends that agencies assess all costs and benefits of available 
regulatory alternatives, including the alternative of not regulating. 
Agencies should consider quantifiable measures and qualitative measure 
of costs and benefits that are difficult to quantify. Further, 
Executive Order 12866 recommends that agencies maximize net benefits 
(including potential economic, environmental, public health and safety, 
and other advantages; distributive impacts; and equity), unless a 
statute requires another regulatory approach. Similarly DOT Order 
2100.6A (``Rulemaking and Guidance Procedures'') requires that 
regulations issued by PHMSA and other DOT Operating Administrations 
should consider an assessment of the potential benefits, costs, and 
other important impacts of the regulatoryaction and should quantify (to 
the extent practicable) the benefits, costs, and any significant 
distributional impacts, including any environmental impacts.
---------------------------------------------------------------------------

    \12\ 58 FR 51735 (Oct. 4, 1993).
---------------------------------------------------------------------------

    Executive Order 12866 and DOT Order 2100.6A require that PHMSA 
submit ``significant regulatory actions'' to the Office of Management 
and Budget (OMB) for review. This rulemaking is not considered a 
significant regulatory action under section 3(f)(1) under Executive 
Order 12866 and, therefore, was not formally reviewed by OMB. 
Furthermore, the final rule is not considered an economically 
significant regulatory action under Section 3(f)(1). The final rule is 
not estimated to have an annual effect on the economy of $100 million 
or more or adversely affect in a material way the economy, a sector of 
the economy, productivity, competition, jobs, the environment, public 
health or safety, or State, local, or Tribal governments or 
communities. Lastly, this rulemaking is also not considered a 
significant rule under DOT Order 2100.6A.
    In promulgating this final rule, PHMSA maintains the safety 
provisions adopted in the IFR, while revising further the lithium 
battery transport regulations to ensure prohibited lithium battery 
packages are not transported as cargo on passenger aircraft and ensure 
better understanding of the requirements to achieve compliance with 
these provisions. In the absence of this rulemaking, potential benefits 
may not be gained, including increased air transportation safety and 
transportation efficiency. These benefits are described qualitatively 
in the final RIA, which is posted in the rulemaking docket. The costs 
of this final rule, which are estimated relative to a baseline of IFR 
regulatory compliance, are qualitatively and quantitatively described 
in the final RIA. These main costs are attributed to the cost of 
reproducing the Sec. Sec.  173.185(c)(i)(iii) or (iv) mark or label

[[Page 78006]]

on the outside of an overpack, when a package bearing such mark or 
label is placed in an overpack and the appropriate mark or label is not 
visible. Based on the analysis described in this final RIA, at the 
mean, PHMSA estimates the present value costs of the final rule are 
estimated at $0.2 million annualized (at a 7 percent discount rate).

C. Executive Order 13132

    PHMSA analyzed this rulemaking in accordance with the principles 
and criteria contained in Executive Order 13132 (``Federalism'') \13\ 
and its implementing Presidential Memorandum (``Preemption'').\14\ 
Executive Order 13132 requires agencies to assure meaningful and timely 
input by state and local officials in development of regulatory 
policies that may 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.''
---------------------------------------------------------------------------

    \13\ 64 FR 43255 (Aug. 4, 1999).
    \14\ 74 FR 24693 (May 22, 2009).
---------------------------------------------------------------------------

    This rulemaking may preempt state, local, and Native American Tribe 
requirements, but does not amend any regulation that has substantial 
direct effects on the states, the relationship between the national 
government and the states, or the distribution of power and 
responsibilities among the various levels of government.
    The Federal hazmat law contains an express preemption provision at 
49 U.S.C. 5125(b) that preempts state, local, and tribal requirements 
on certain covered subjects, unless the non-federal requirements are 
``substantively the same'' as the federal requirements, including the 
following:
    (1) the designation, description, and classification of hazardous 
material;
    (2) the packing, repacking, handling, labeling, marking, and 
placarding of hazardous material;
    (3) the preparation, execution, and use of shipping documents 
related to hazardous material and requirements related to the number, 
contents, and placement of those documents;
    (4) the written notification, recording, and reporting of the 
unintentional release in transportation of hazardous material; and
    (5) the design, manufacture, fabrication, inspection, marking, 
maintenance, recondition, repair, or testing of a packaging or 
container represented, marked, certified, or sold as qualified for use 
in transporting hazardous material in commerce.
    This rule addresses subject items (2) and (5) above, which are 
covered subjects, and therefore, non-federal requirements that fail to 
meet the ``substantively the same'' standard are vulnerable to 
preemption under the Federal hazmat law. Moreover, PHMSA will continue 
to make preemption determinations applicable to specific non-federal 
requirements on a case-by-case basis, using the obstacle, dual 
compliance, and covered subjects tests provided in Federal hazmat law.
    Therefore, the consultation and funding requirements of Executive 
Order 13132 do not apply. Consistent with 49 U.S.C. 5125, this final 
rule will preempt any State, local, or tribal requirements concerning 
the subjects identified in 49 U.S.C. 5125(b)(1) unless the non-Federal 
requirements are ``substantively the same'' as the Federal 
requirements. In addition, this final rule does not have sufficient 
federalism impacts to warrant the preparation of a federalism 
assessment.

D. Executive Order 13175

    PHMSA analyzed this rulemaking in accordance with the principles 
and criteria contained in Executive Order 13175 (``Consultation and 
Coordination with Indian Tribal Governments'') \15\ and DOT Order 
5301.1 (``Department of Transportation Policies, Programs, and 
Procedures Affecting American Indians, Alaska Natives, and Tribes''). 
Executive Order 13175 and DOT Order 5301.1 require DOT Operating 
Administrations to assure meaningful and timely input from Native 
American Tribal government representatives in the development of rules 
that significantly or uniquely affect tribal communities by imposing 
``substantial direct compliance costs'' or ``substantial direct 
effects'' on such communities or the relationship and distribution of 
power between the federal government and Native American Tribes. 
Because this rulemaking does not significantly or uniquely affect the 
communities of Tribal governments and does not impose substantial 
direct compliance costs, the funding and consultation requirements of 
Executive Order 13175 and DOT Order 5301.1 do not apply.
---------------------------------------------------------------------------

    \15\ 65 FR 67249 (Nov. 6, 2000).
---------------------------------------------------------------------------

E. Regulatory Flexibility Act and Executive Order 13272

    The Regulatory Flexibility Act (5 U.S.C. 601 et seq.) requires 
agencies to consider whether a rulemaking would have a ``significant 
economic impact on a substantial number of small entities'' to include 
small business, not-for-profit organizations that are independently 
owned and operated and are not dominant in their fields, and 
governmental jurisdictions with populations under 50,000. The 
Regulatory Flexibility Act directs agencies to establish exceptions and 
differing compliance standards for small businesses, where possible to 
do so and still meet the objectives of applicable regulatory statutes. 
Executive Order 13272 (``Proper Consideration of Small Entities in 
Agency Rulemaking'') \16\ requires agencies to establish procedures and 
policies to promote compliance with the Regulatory Flexibility Act and 
to ``thoroughly review draft rules to assess and take appropriate 
account of the potential impact'' of the rulemakings on small 
businesses, governmental jurisdictions, and small organizations. The 
DOT posts its implementing guidance on a dedicated web page.\17\
---------------------------------------------------------------------------

    \16\ 67 FR 53461 (Aug. 16, 2002).
    \17\ DOT, ``Rulemaking Requirements Related to Small Entities,'' 
https://www.transportation.gov/regulations/rulemaking-requirements-concerning-small-entities (last accessed June 17, 2021).
---------------------------------------------------------------------------

    This rulemaking has been developed in accordance with Executive 
Order 13272 and with DOT's procedures and policies to promote 
compliance with the Regulatory Flexibility Act to ensure that potential 
impacts of rules on small entities are properly considered. This 
rulemaking addresses safety risks that lithium batteries present in 
transportation, primarily the risk to passenger aircraft, and 
facilitates the transportation of hazardous materials in international 
commerce by providing consistency with international standards. It 
applies to offerors and carriers of lithium batteries, some of whom are 
small entities. This includes lithium cell and battery manufacturers, 
wholesalers, and retailers. As discussed at length in the final RIA 
posted in the rulemaking docket, the amendments in this final rule 
impose minimal costs to shippers of lithium cells and batteries when 
offering a package of lithium cells and batteries in an overpack. 
However, these costs address a necessary safety gap to ensure the 
safety of air transportation of lithium cells and batteries. As 
detailed in the final RIA, PHMSA expects that these amendments will not 
have a significant economic impact on a substantial number of small 
entities. For further detail, please review the final regulatory 
flexibility analysis in the final RIA posted in the rulemaking docket.

F. Paperwork Reduction Act

    Under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.), 
no person is required to respond to any

[[Page 78007]]

information collection unless is has been approved by OMB and displays 
a valid OMB control number. Pursuant to 44 U.S.C. 3506(c)(2)(B) and 5 
CFR 1320.8(d), PHMSA must provide interested members of the public and 
affected agencies an opportunity to comment on information collection 
and recordkeeping requests.
    PHMSA has analyzed this final rule in accordance with the Paperwork 
Reduction Act. PHMSA currently has approved information collections 
under OMB Control Numbers 2137-0034, ``Hazardous Materials Shipping 
Papers and Emergency Response Information'' and 2137-0557, ``Approvals 
for Hazardous Materials.'' In response to the IFR, PHMSA did not 
receive any comments related to these information collections. However, 
for the benefit of the reader of this final rule, the IFR discussion of 
the estimated paperwork burden follows.
    For OMB control number 2137-0034, PHMSA estimated a revision in 
paperwork and recordkeeping burden as a result of smaller lithium 
batteries being transported as fully regulated shipments. PHMSA 
estimated this change in shipment because of the required consignment 
limitation. When shipped without certain provisions in Sec.  
173.185(c), the shipments are subject to shipping papers and 
Notification to the Pilot in Command (NOPIC) requirements in Sec.  
175.33. PHMSA estimated that there will be an additional 28,242 
shipments annually that will require a shipping paper. PHMSA also 
estimated that each shipping paper takes one minute and 30 seconds to 
complete (28,242 shipments x 90 seconds), resulting in approximately 
741 additional burden hours. PHMSA did not estimate any increase in 
out-of-pocket costs. The NOPIC is estimated to take one (1) minute per 
shipment (28,242 shipments x 1 minute), which resulted in an increase 
of approximately 471 burden hours. PHMSA did not estimate any increase 
in out-of-pocket costs. In total for this information collection, PHMSA 
estimated an approximate increase of 56,484 annual number of responses 
(28,242 shipping paper responses + 28,242 NOPIC responses) and 
approximate increase of 1,212 burden hours (741 shipping paper burden 
hours + 471 NOPIC burden hours).
    For OMB control number 2137-0557, PHMSA estimated that the changes 
will lead to an additional 468 approval requests. This increase in 
approval requests resulted from the requirement that lithium ion cells 
and batteries, when transported by cargo aircraft, may only be shipped 
at greater than a 30 percent SOC under an approval by the Associate 
Administrator. As detailed in the IFR, PHMSA estimated that it takes 
approximately 40 hours to complete the paperwork portion of an approval 
request, resulting in 18,720 additional burden hours (468 approval 
requests x 40 hours per request). PHMSA did not estimate any increase 
in out-of-pocket costs.
    A summary of the information collection changes from the rulemaking 
can be found below:
OMB Control Number 2137-0034
    Annual Increase in Number of Respondents: 0.
    Annual Increase in Annual Number of Responses: 56,484.
    Annual Increase in Annual Burden Hours: 1,212.
    Annual Increase in Annual Burden Costs: $0.
OMB Control Number 2137-0557
    Annual Increase in Number of Respondents: 468.
    Annual Increase in Annual Number of Responses: 468.
    Annual Increase in Annual Burden Hours: 18,720.
    Annual Increase in Annual Burden Costs: $0.

G. Unfunded Mandates Reform Act of 1995

    The Unfunded Mandates Reform Act of 1995 (URMA; 2 U.S.C. 1501 et 
seq.) requires agencies to assess the effects of federal regulatory 
actions on state, local, and tribal governments, and the private 
sector. For any NPRM or final rule that includes a federal mandate that 
may result in the expenditure by state, local, and tribal governments, 
or by the private sector of $100 million or more in 1996 dollars in any 
given year, the agency must prepare, amongst other things, a written 
statement that qualitatively and quantitatively assesses the costs and 
benefits of the Federal mandate.
    This final rule does not impose unfunded mandates under the UMRA. 
As explained above, it is not expected to result in costs of $100 
million or more in 1996 dollars on either state, local, or tribal 
governments, in the aggregate, or to the private sector in any one 
year, and is the least burdensome alternative that achieves the 
objective of the rulemaking.

H. Environmental Assessment

    The National Environmental Policy Act of 1969 (NEPA; 42 U.S.C. 4321 
et seq.), requires that federal agencies analyze actions to determine 
whether the action would have a significant impact on the human 
environment. The Council on Environmental Quality implementing 
regulations (40 CFR parts 1500-1508) require federal agencies to 
conduct an environmental review considering (1) the need for the 
action, (2) alternatives to the action, (3) probable environmental 
impacts of the action and alternatives, and (4) the agencies and 
persons consulted during the consideration process. DOT Order 5610.1C 
(``Procedures for Considering Environmental Impacts'') establishes 
departmental procedures for evaluation of environmental impacts under 
NEPA and its implementing regulations.
1. Need for the Action
    This final rule is being promulgated in response to comments to the 
IFR. The final rule maintains IFR provisions including the: (1) 
prohibition of the transport of lithium ion cells and batteries as 
cargo on passenger aircraft; (2) requirement for all lithium ion cells 
and batteries to be shipped at not more than a 30 percent SOC on cargo-
only aircraft; and (3) restriction for smaller lithium cell and battery 
shipments to one package per consignment or overpack. These provisions 
addressed safety concerns from lithium battery transportation risks and 
mandates from the FAA Reauthorization Act of 2018, including adding an 
exception, with approval from the Associate Administrator, for certain 
medical device lithium batteries.
    This final rule provides amendments on certain IFR provisions 
including marking requirements. In addition, the final rule addresses a 
safety need by requiring that when a package of smaller lithium cells 
and batteries that requires a Sec. Sec.  173.185(c)(1)(iii) or (iv) 
mark or label is placed in an overpack, the appropriate mark or label 
must be visible or reproduced on the overpack.
    As explained in greater length in this preamble, final RIA, and in 
the IFR preamble, this rulemaking addresses safety concerns from 
lithium batteries when transported by air. PHMSA expects that the 
continuation of the provisions adopted in the IFR and the revisions in 
this final rule increase the high safety standard currently achieved 
under the HMR. PHMSA has evaluated each of the amendments on its own 
merit, as well as the aggregate impact on transportation safety from 
adoption of those amendments. This EA focuses on the regulatory changes 
specific to this final rule. The EA for the IFR is available in the 
rulemaking docket.\18\
---------------------------------------------------------------------------

    \18\ PHMSA-2016-0014

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

[[Page 78008]]

2. Alternatives Considered
    PHMSA considered the following alternatives:
    Selected Alternative:
    The Selected Alternative is the current rulemaking as it appears in 
this final rule. This final rule revises the IFR regulatory text to 
ensure the requirements more appropriately harmonize with those 
amendments in the ICAO Technical Instructions. In addition, PHMSA adds 
a requirement, to respond to an omission in the IFR, that when a 
package bears a Sec. Sec.  173.185(c)(1)(iii) or (iv) mark or label and 
is placed in an overpack, the appropriate mark or label must be visible 
or reproduced on the overpack. The amendments included in this 
alternative are more fully discussed in the preamble and regulatory 
text section of this rulemaking. The Selected Alternative also 
clarifies certain marking provisions from the IFR. Also, the Selected 
Alternative provides more specificity about the approval process to 
allow certain lithium batteries for medical equipment on aircrafts.
    No Action Alternative:
    If PHMSA were to select the No Action Alternative, PHMSA would not 
make any amendments to the IFR, and current regulations remain in 
place. No provisions would be amended or added. The HMR would not be 
fully consistent with the ICAO Technical Instructions. The HMR would 
not be updated to provide important details for the approval process 
related to the transportation of lithium batteries in medical 
equipment.
3. Environmental Impacts
    Selected Alternative:
    PHMSA anticipates that overall, the changes under the Selected 
Alternative increase the high safety standards currently achieved in 
the HMR. PHMSA expects that proper harmonization of the HMR with the 
ICAO Technical Instructions for lithium battery transportation will 
result in greater protection of human health and the environment by 
further decreasing the likelihood that an unauthorized package 
containing lithium batteries could be shipped via cargo or passenger 
aircraft, which could potentially cause a dangerous incident in air 
travel. In addition, this harmonization is expected to capture economic 
and logistic efficiencies gained from avoiding shipping delays and 
reshipments associated with having to comply with divergent U.S. and 
international regulatory requirements for transportation of lithium 
batteries by aircraft. These delays and reshipments can have 
incremental environmental impacts. In addition, PHMSA expects that 
ensuring visibility of the markings and labels reduces the risk of harm 
to human safety and environmental resources from an incident caused by 
lithium batteries on an aircraft.
    PHMSA expects that the Selected Alternative could realize modest 
reductions in greenhouse gas (GHG) emissions because the differences in 
the current HMR and the ICAO Technical Instructions for the 
transportation of lithium batteries absent the changes made in this 
final rule could potentially result in delays or interruptions. PHMSA 
anticipates that the No Action Alternative could result in modestly 
higher GHG emissions from some combination of (1) transfer of delayed 
hazardous materials to and from interim storage, (2) return of 
improperly shipped materials to their point of origin, or (3) 
reshipment of returned materials. The Selected Alternative reduces the 
inconsistences from the divergence of the HMR and the ICAO Technical 
Instructions for lithium battery transportation by air and thus, avoids 
potential transportation inefficiencies. However, PHMSA is unable to 
quantify any GHG emissions benefits because of the difficulty in 
estimating or identifying the quantity or characteristics of such 
interim storage or returns/reshipments. The only potential 
environmental impact associated with the Selected Alternative would 
result from the production of additional markings or labels that must 
be affixed to the any overpack when the original marking or label is 
not visible through the overpack. The impact would be extremely 
minimal.
    Lastly, the Selected Alternative would avoid any adverse impacts 
for minority populations, low-income populations, or other underserved 
and other disadvantaged communities resulting from the potential 
shipping delays because of the divergence between the HMR and the ICAO 
Technical Instructions for lithium battery shipments.
    No Action Alternative:
    Under the No Action Alternative, current regulations would remain 
in place, and PHMSA would not make additional amendments to the HMR 
related to the air transportation of batteries to fully achieve the 
purpose of the IFR. Not adopting the amendments that clarify and 
address a potential hazard communication gap in this final rule under 
the No Action Alternative would allow an unintentional gap in marking 
requirements to persist, which could make it more like that a 
prohibited package could be offered for transportation on a passenger 
aircraft.
    Additionally, efficiencies gained through proper harmonization in 
updates to transport standards would not be realized. Foregone 
efficiencies in the No Action Alternative include freeing up limited 
resources to concentrate on air transport hazard communication issues 
of potentially greater environmental impact.
4. Agencies Consulted
    PHMSA has coordinated with the FAA, the Federal Motor Carrier 
Safety Administration, the Federal Railroad Administration, and the 
U.S. Coast Guard in the development of this rulemaking. The final rule 
has also been made available to other federal agencies within the 
interagency review process consistent with Executive Order 12866.
5. Finding of No Significant Impact
    The adoption of the Selected Alternative's regulatory amendments 
enhances the safe and secure transportation of lithium batteries by 
aircraft, thereby reducing the risks of an accidental or intentional 
release of hazardous materials that could result in a catastrophic 
incident on an aircraft, potential loss of life and subsequent 
environmental damage. Furthermore, PHMSA expects that the Selected 
Alternative will avoid adverse safety, environmental justice, and GHG 
emissions impacts of the No Action Alternative. Therefore, PHMSA finds 
that the final rule amendments would have no significant environmental 
impacts on the human environment.

I. Executive Order 12898

    Executive Orders 12898 (``Federal Actions to Address Environmental 
Justice in Minority Populations and Low-Income Populations''),\19\ 
13985 (``Advancing Racial Equity and Support for Underserved 
Communities Through the Federal Government''),\20\ 13990 (``Protecting 
Public Health and the Environment and Restoring Science To Tackle the 
Climate Crisis''),\21\ 14008 (``Tackling the Climate Crisis at Home and 
Abroad''),\22\ and DOT Order 5610.2C (``Department of Transportation 
Actions to Address Environmental Justice in Minority Populations and 
Low-Income Populations'') require DOT agencies to achieve environmental 
justice as part of their mission by identifying and addressing, as 
appropriate, disproportionately high

[[Page 78009]]

and adverse human health or environmental effects, including 
interrelated social and economic effects of their programs, policies, 
and activities on minority populations, low-income populations, and 
other underserved and disadvantaged communities.
---------------------------------------------------------------------------

    \19\ 59 FR 7629 (Feb. 11, 1994).
    \20\ 86 FR 7009 (Jan. 20, 2021).
    \21\ 86 FR 7037 (Jan. 20, 2021).
    \22\ 86 FR 7619 (Feb. 1, 2021).
---------------------------------------------------------------------------

    PHMSA has evaluated this final rule under the above Executive 
Orders and DOT Order 5610.2C and expects it would not cause 
disproportionately high and adverse human health and environmental 
effects on minority, low-income, underserved, and other disadvantaged 
populations and communities. The rulemaking is facially neutral and 
national in scope; it is neither directed toward a particular 
population, region, or community, nor is it expected to adversely 
impact any particular population, region, or community. And insofar as 
PHMSA expects the rulemaking would not adversely affect the safe 
transportation of hazardous materials generally, PHMSA does not expect 
the amendments would entail disproportionately high adverse risks for 
minority populations, low-income populations, or other underserved and 
other disadvantaged communities.
    The final rule could reduce risks to minority populations, low-
income populations, or other underserved and other disadvantaged 
communities. Insofar as the HMR amendments could avoid the release of 
hazardous materials, the final rule could reduce risks to populations 
and communities--including any minority, low-income, underserved, and 
other disadvantaged populations and communities--in the vicinity of 
interim storage sites and transportation arteries and hubs. 
Additionally, as explained in the above discussion of NEPA, PHMSA 
expects that the final rule amendments will yield modest GHG emissions 
reductions, thereby reducing the risks posed by anthropogenic climate 
change to minority, low-income, underserved, and other disadvantaged 
populations, and communities.

J. Privacy Act

    In accordance with 5 U.S.C. 553(c), DOT solicits comments from the 
public to better inform its rulemaking process. DOT posts these 
comments, without edit, including any personal information the 
commenter provides, to http://www.regulations.gov, as described in the 
system of records notice (DOT/ALL-14 FDMS), which can be reviewed at 
http://www.dot.gov/privacy. DOT's complete Privacy Act Statement can be 
reviewed in the Federal Register published on April 11, 2000,\23\ or on 
DOT's website at http://www.dot.gov/privacy.
---------------------------------------------------------------------------

    \23\ 65 FR 19475 (Apr. 11, 2000).
---------------------------------------------------------------------------

K. Executive Order 13609 and International Trade Analysis

    Executive Order 13609 (``Promoting International Regulatory 
Cooperation'') \24\ requires that agencies must consider whether the 
impacts associated with significant variations between domestic and 
international regulatory approaches are unnecessary or may impair the 
ability of American business to export and compete internationally. In 
meeting shared challenges involving health, safety, labor, security, 
environmental, and other issues, international regulatory cooperation 
can identify approaches that are at least as protective as those that 
are or would be adopted in the absence of such cooperation. 
International regulatory cooperation can also reduce, eliminate, or 
prevent unnecessary differences in regulatory requirements.
---------------------------------------------------------------------------

    \24\ 77 FR 26413 (May 1, 2012).
---------------------------------------------------------------------------

    Similarly, the Trade Agreements Act of 1979 (Pub. L. 96-39), as 
amended by the Uruguay Round Agreements Act (Pub. L. 103-465), 
prohibits federal agencies from establishing any standards or engaging 
in related activities that create unnecessary obstacles to the foreign 
commerce of the United States. Pursuant to the Trade Agreements Act, 
the establishment of standards is not considered an unnecessary 
obstacle to foreign commerce of the United States, so long as the 
standards have a legitimate domestic objective, such as providing for 
safety, and do not operate to exclude imports that meet this objective. 
The statute also requires consideration of international standards and, 
where appropriate, that they be the basis for U.S. standards.
    PHMSA participates in the establishment of international standards 
in order to protect the safety of the American public, and we have 
assessed the effects of the rulemaking to ensure that it does not cause 
unnecessary obstacles to foreign trade. In this case, the final rule 
further harmonizes U.S. lithium battery provisions with the ICAO 
Technical Instructions so as to reduce regulatory burdens and minimize 
delays arising from having to comply with divergent regulatory 
requirements. Accordingly, this rulemaking is consistent with Executive 
Order 13609 and PHMSA's obligations under the Trade Agreement Act, as 
amended.

L. Executive Order 13211

    Executive Order 13211 (``Actions Concerning Regulations That 
Significantly Affect Energy Supply, Distribution, or Use'') \25\ 
requires Federal agencies to prepare a Statement of Energy Effects for 
any ``significant energy action.'' Executive Order 13211 defines a 
``significant energy action'' 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 that (1)(i) 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 (including a shortfall in 
supply, price increases, and increased use of foreign supplies); or (2) 
is designated by the Administrator of the Office of Information and 
Regulatory Affairs (OIRA) as a significant energy action.
---------------------------------------------------------------------------

    \25\ 66 FR 28355 (May 22, 2001).
---------------------------------------------------------------------------

    This final rule is a non-significant action under Executive Order 
12866, and PHMSA expects it to have an annual effect on the economy of 
less than $100 million. Further, this action is not likely to have a 
significant adverse effect on the supply, distribution, or use of 
energy in the United States. The Administrator of OIRA has not 
designated the final rule as a significant energy action. For 
additional discussion of the anticipated economic impact of this 
rulemaking, please review the final RIA posted in the rulemaking 
docket.

List of Subjects

49 CFR Part 107

    Administrative practice and procedure, Hazardous materials 
transportation, Packaging and containers, Penalties, Reporting and 
recordkeeping requirements.

49 CFR Part 171

    Exports, Hazardous materials transportation, Hazardous waste, 
Imports, Reporting and recordkeeping requirements.

49 CFR Part 173

    Hazardous materials transportation, Packaging and containers, 
Radioactive materials, Reporting and recordkeeping requirements, 
Uranium.

    In consideration of the foregoing, PHMSA amends 49 CFR chapter I as 
follows:

[[Page 78010]]

PART 107--HAZARDOUS MATERIALS PROGRAM PROCEDURES

0
1. The authority citation for part 107 is amended to read as follows:

    Authority:  49 U.S.C. 5101-5128, 44701; Pub. L. 101-410 Section 
4; Pub. L. 104-121 Sections 212-213; Pub. L. 104-134 Section 31001; 
Pub. L. 114-74 Section 701 (28 U.S.C. 2461 note); 49 CFR 1.81 and 
1.97; 33 U.S.C. 1321.

0
2. In Sec.  107.705, revise paragraphs (b)(4) and (b)(5)(ii) and add 
paragraph (b)(6) to read as follows:

Sec.  107.705   Registrations, reports, and applications for approval.

* * * * *
    (b) * * *
    (4) Any additional information specified in the section containing 
the approval;
    (5) * * *
    (ii) Substantiation, with applicable analyses or evaluations, if 
appropriate, demonstrating that the proposed activity will achieve a 
level of safety that is at least equal to that required by the 
regulation; and
    (6) For lithium cells and batteries used for a medical device and 
transported in accordance with Sec.  173.185(g) of this chapter, 
details on the extent to which the destination(s) of the lithium cell 
or battery is not serviced daily by cargo aircraft.
* * * * *

0
3. In Sec.  107.709, revise paragraphs (b) and (f) to read as follows:

Sec.  107.709   Processing of an application for approval, including an 
application for renewal or modification.

* * * * *
    (b) The Associate Administrator will review an application for an 
approval, modification of an approval, or renewal of an approval in 
conformance with the standard operating procedures specified in 
appendix A of this part (``Standard Operating Procedures for Special 
Permits and Approvals''). The Associate Administrator will conduct an 
expedited review process for shipments of lithium cells and batteries 
specifically used for medical devices, as outlined in Sec.  173.185(g) 
of this chapter. At any time during the processing of an application, 
the Associate Administrator may request additional information from the 
applicant. If the applicant does not respond to a written request for 
additional information within 30 days of the date the request was 
received, the Associate Administrator may deem the application 
incomplete and deny it. The Associate Administrator may grant a 30-day 
extension to respond to the written request for additional information 
if the applicant makes such a request in writing.
* * * * *
    (f) The Associate Administrator notifies the applicant in writing 
of the decision on the application. A denial contains a brief statement 
of reasons. For shipments of lithium cells and batteries specifically 
used for medical devices, as outlined in Sec.  173.185(g) of this 
chapter, an approval shall be considered and either granted or denied 
not later than 45 days after receipt of a completed application.

PART 171--GENERAL INFORMATION, REGULATIONS, AND DEFINITIONS

0
4. The authority citation for part 171 is revised to read as follows:

    Authority:  49 U.S.C. 5101-5128, 44701; Pub. L. 101-410 section 
4; Pub. L. 104-134, section 31001; Pub. L. 114-74 section 701 (28 
U.S.C. 2461 note); 49 CFR 1.81 and 1.97.

0
5. In Sec.  171.12, revise paragraph (a)(6) to read as follows:

Sec.  171.12   North American Shipments.

    (a) * * *
    (6) Lithium cells and batteries. Lithium metal cells and batteries 
(UN3090) and lithium ion cells and batteries (UN3480) are forbidden for 
transport as cargo aboard passenger-carrying aircraft. The outside of 
each package or overpack that contains lithium cells or batteries 
meeting the conditions for exception in Sec.  173.185(c) of this 
subchapter and transported in accordance with the Transport Canada TDG 
Regulations must be marked or labeled in accordance with Sec.  
173.185(c)(1)(iii), (iv), and (vi), as appropriate.
* * * * *

0
6. In Sec.  171.24, revise paragraph (d)(1)(ii) to read as follows:

Sec.  171.24   Additional requirements for the use of the ICAO 
Technical Instructions.

* * * * *
    (d) * * *
    (1) * * *
    (ii) Lithium cells and batteries. Lithium metal cells and batteries 
(UN3090) and lithium ion cells and batteries (UN3480) are forbidden for 
transport as cargo aboard passenger-carrying aircraft. The outside of 
each package that contains lithium metal cells or batteries transported 
in accordance with Packing Instruction 968, Section II or lithium ion 
cells or batteries transported in accordance with Packing Instruction 
965, Section II must be appropriately marked: ``PRIMARY LITHIUM 
BATTERIES--FORBIDDEN FOR TRANSPORT ABOARD PASSENGER AIRCRAFT'', 
``LITHIUM METAL BATTERIES--FORBIDDEN FOR TRANSPORT ABOARD PASSENGER 
AIRCRAFT'', ``LITHIUM ION BATTERIES--FORBIDDEN FOR TRANSPORT ABOARD 
PASSENGER AIRCRAFT'', or ``LITHIUM BATTERIES--FORBIDDEN FOR TRANSPORT 
ABOARD PASSENGER AIRCRAFT'', or labeled with a CARGO AIRCRAFT ONLY 
label as specified in Sec.  172.448 of this subchapter. When placed in 
an overpack, the selected mark or label must either be clearly visible 
through the overpack, or the marking or label must be affixed on the 
outside of the overpack.
* * * * *

0
7. In Sec.  171.25, revise paragraph (b)(3) to read as follows:

Sec.  171.25   Additional requirements for the use of the IMDG Code.

* * * * *
    (b) * * *
    (3) The outside of each package containing lithium metal cells or 
batteries (UN3090) or lithium ion cells or batteries (UN3480) 
transported in accordance with special provision 188 of the IMDG Code 
must be appropriately marked ``PRIMARY LITHIUM BATTERIES--FORBIDDEN FOR 
TRANSPORT ABOARD PASSENGER AIRCRAFT'', ``LITHIUM METAL BATTERIES--
FORBIDDEN FOR TRANSPORT ABOARD PASSENGER AIRCRAFT'', ``LITHIUM ION 
BATTERIES--FORBIDDEN FOR TRANSPORT ABOARD PASSENGER AIRCRAFT'', or 
``LITHIUM BATTERIES--FORBIDDEN FOR TRANSPORT ABOARD PASSENGER 
AIRCRAFT'', or labeled with a CARGO AIRCRAFT ONLY label as specified in 
Sec.  172.448 of this subchapter. The provisions of this paragraph also 
apply to packages of lithium cells or batteries packed with, or 
contained in, equipment that exceed 5 kg (11 pounds) net weight. When 
placed in an overpack, the selected marking or label must either be 
clearly visible through the overpack, or the marking or label must also 
be affixed on the outside of the overpack.
* * * * *

PART 173--SHIPPERS--GENERAL REQUIREMENTS FOR SHIPMENTS AND 
PACKAGINGS

0
8. The authority citation for part 173 continues to read as follows:

    Authority:  49 U.S.C. 5101-5128, 44701; 49 CFR 1.81, 1.96 and 
1.97.

0
9. In Sec.  173.185:
0
a. Revise paragraphs (c)(1)(iii) and (iv);

[[Page 78011]]

0
b. Redesignate paragraph (c)(1)(vi) as paragraph (c)(1)(vii);
0
c. Add new paragraph (c)(1)(vi); and
0
d. Revise paragraphs (c)(4)(i) introductory text and (c)(4)(ii), (iii), 
(v), and (viii).
    The revisions and addition read as follows:

Sec.  173.185   Lithium cells and batteries.

* * * * *
    (c) * * *
    (1) * * *
    (iii) Except when lithium cells or batteries are packed with or 
contained in equipment in quantities not exceeding 5 kg net weight, the 
outer package that contains lithium cells or batteries must be 
appropriately marked: ``PRIMARY LITHIUM BATTERIES--FORBIDDEN FOR 
TRANSPORT ABOARD PASSENGER AIRCRAFT'', ``LITHIUM METAL BATTERIES--
FORBIDDEN FOR TRANSPORT ABOARD PASSENGER AIRCRAFT'', ``LITHIUM ION 
BATTERIES--FORBIDDEN FOR TRANSPORT ABOARD PASSENGER AIRCRAFT'', or 
``LITHIUM BATTERIES--FORBIDDEN FOR TRANSPORT ABOARD PASSENGER 
AIRCRAFT'', or labeled with a ``CARGO AIRCRAFT ONLY'' label as 
specified in Sec.  172.448 of this subchapter.
    (iv) For transportation by highway or rail only, the lithium 
content of the cell and battery may be increased to 5 g for a lithium 
metal cell or 25 g for a lithium metal battery and 60 Wh for a lithium 
ion cell or 300 Wh for a lithium ion battery, provided the outer 
package is marked: ``LITHIUM BATTERIES--FORBIDDEN FOR TRANSPORT ABOARD 
AIRCRAFT AND VESSEL.'' A package marked in accordance with this 
paragraph does not need to display the marking required in paragraph 
(c)(1)(iii) of this section.
* * * * *
    (vi) When a package marked or labeled in accordance with paragraph 
(c)(1)(iii) or (iv) of this section is placed in an overpack, the 
selected marking or label must either be clearly visible through the 
overpack, or the marking or label must also be affixed on the outside 
of the overpack.
* * * * *
    (4) * * *
    (i) For transportation by aircraft, lithium cells and batteries may 
not exceed the limits in the following Table 1 to paragraph (c)(4)(i). 
The limits on the maximum number of batteries and maximum net quantity 
of batteries in the following table may not be combined in the same 
package. The limits in the following table do not apply to lithium 
cells and batteries packed with, or contained in, equipment.
* * * * *
    (ii) Not more than one package prepared in accordance with 
paragraph (c)(4)(i) of this section may be placed into an overpack.
    (iii) A shipper is not permitted to offer for transport more than 
one package prepared in accordance with the provisions of paragraph 
(c)(4)(i) of this section in any single consignment.
* * * * *
    (v) Packages and overpacks of lithium batteries prepared in 
accordance with paragraph (c)(4)(i) of this section must be offered to 
the operator separately from cargo which is not subject to the 
requirements of this subchapter and must not be loaded into a unit load 
device before being offered to the operator.
* * * * *
    (viii) Lithium cells and batteries must not be packed in the same 
outer packaging with other hazardous materials. Packages prepared in 
accordance with paragraph (c)(4)(i) of this section must not be placed 
into an overpack with packages containing hazardous materials and 
articles of Class 1 (explosives) other than Division 1.4S, Division 2.1 
(flammable gases), Class 3 (flammable liquids), Division 4.1 (flammable 
solids), or Division 5.1 (oxidizers).
* * * * *

    Issued in Washington, DC, on December 14, 2022, under authority 
delegated in 49 CFR part 1.97.
Tristan H. Brown,
Deputy Administrator, Pipeline and Hazardous Materials Safety 
Administration.
[FR Doc. 2022-27563 Filed 12-20-22; 8:45 am]
BILLING CODE 4910-60-P