{"operation":"document","citation":"87 FR 77995","title":"Hazardous Materials: Enhanced Safety Provisions for Lithium Batteries Transported by Aircraft (FAA Reauthorization Act of 2018)","source_type":"rulemaking","agency":"Pipeline and Hazardous Materials Safety Administration","status":"historical","official":true,"published_on":"2022-12-21","effective_on":"2023-01-20","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.","machine_formats":{"json":"https://regulus.evalyn.ai/document/federal-register-2022-27563.json","markdown":"https://regulus.evalyn.ai/document/federal-register-2022-27563.md"},"app_url":"https://regulus.evalyn.ai/document/federal-register-2022-27563","source_url":"https://www.federalregister.gov/documents/2022/12/21/2022-27563/hazardous-materials-enhanced-safety-provisions-for-lithium-batteries-transported-by-aircraft-faa","body":"Federal Register, Volume 87 Issue 244 (Wednesday, December 21, 2022) [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 ","truncated":true,"body_characters":119579}