{"operation":"document","citation":"11-0044","title":"O2 Concepts, LLC — Hazardous Materials Safety Interpretation","source_type":"guidance","agency":"Pipeline and Hazardous Materials Safety Administration","status":"guidance","official":true,"published_on":"2011-03-23","effective_on":null,"summary":"11-0044 response to O2 Concepts, LLC concerning 173.185.","machine_formats":{"json":"https://regulus.evalyn.ai/document/phmsa-interpretation-11-0044.json","markdown":"https://regulus.evalyn.ai/document/phmsa-interpretation-11-0044.md"},"app_url":"https://regulus.evalyn.ai/document/phmsa-interpretation-11-0044","source_url":"https://www.phmsa.dot.gov/sites/phmsa.dot.gov/files/legacy/interpretations/Interpretations/2011/110044.pdf","body":"<<<PAGE 1>>>\n\nU.S. Department of Transportation 1200 New Jersey Avenue. SE\nwashington, DC 20590\nPipeline and Hazardous Materials\nSafety Administration\nMAR 23 2011\nMs. Kathryn G. Forgione\nVice President of Quality\n02 Concepts, LLC\n14001 McAuley Blvd., Suite 170\nOklahoma City, OK 73134\nRef. No.: 11-0044\nDear Ms. Forgione:\nThis responds to your February 15,2011 letter regarding the applicability ofthe Hazardous\nMaterials Regulations (HMR; 49 CFR Parts 171-180) to a portable oxygen concentrator.\nSpecifically you ask ifthe OxLife Independence oxygen concentrator is compliant with\nSpecial Provision 188. For your information, in December 2008 this office responded to a\nsimilar request for interpretation from OxLife, LLC (Ref. No. 08-0237). In your letter you\nindicated that in 2010 your company purchased the appropriate legal rights to the OxLife\nIndependence oxygen concentrator.\nThe information you provided in your letter, reiterates that provided by OxLife LLC in 2008\nconcerning the contents ofthe OxLife Independence oxygen concentrator. You indicate the\nfollowing:\n1. The pressure of the oxygen in the device does not exceed 40.6 psia at 20 degrees C;\n2. The cells contain no more than 1.5 grams of lithium equivalent content;\n3. The lithium ion battery contains an aggregate equivalent lithium content ofnot more\nthan 8 g;\n4. The device contains no other materials subject to the HMR; and\n5. The batteries are fully contained in equipment and packaged in a manner to preclude\nsparks or the generation ofa dangerous quantity ofheat.\nBased on the information provided, the OxLife Independence portable oxygen concentrator\nmeets the requirements of Special Provision 188. Provided it continues to meet the\nrequirements established in Special Provision 188, it is not otherwise subject to the HMR.\n\n<<<PAGE 2>>>\n\nYou should also note that F ederal Aviation Administration (F AA) approval is required before\nthese electronic devices may be used by passengers on board aircraft. The FAA published a\nfinal rule in the Federal Register regarding these devices on July 12,2005 (70 FR 40156). A\ncopy ofthe rulemaking is enclosed.\nI hope this answers your inquiry. If you need additional assistance, please contact the\nStandards and Rulemaking Division at 202-366-8553.\nSincerely,\nBenSupko\nActing Chief, Standards Development Branch\nStandards and Rulemaking Division\nEnclosure\n\n<<<PAGE 3>>>\n\nA-~2\nCONCEPTS\nFebruary 15, 2011\nOffice of Hazardous Materials Standards\nU.S. DOT/PHMSA (PHH-I0)\n1200 New Jersey Avenue, SE East Building, 2nd Floor\nWashington, DC 20590\nAttention: Mr. Edward T. Mazzullo, Director\nDear Mr. Mazzullo,\nIn 2010, 02 Concepts, LLC purchased all intangible assets to the' OxLife Independence, a Portable\nOxygen Concentrator, from OxLife, LLC who obtained FDA clearance for this product on April 16, 2008\nunder K080082.\nThe device is a portable oxygen concentrator designed to deliver supplemental oxygen to adult patients.\nThis product is manufactured according to FDA's Quality System Regulation part 820 and Quality\nManagement System according to ISO 13485.\n02 Concepts, LLC is preparing to launch the OxLife Independence (Model #800-0001) and is requesting a\nconfirmation that the OxLife Independence is compliant with the HMR, Special Provision 188.\nThe OxLife Independence meets the following criteria:\n1. 3. The pressure of the oxygen in the device does not exceed 40.6 psia at 20 degrees C.\n2. The cells contain no more than 1.5 grams of lithium equivalent content.\nThe lithium ion battery contains an aggregate equivalent lithium content of not more than 8g and\nhas been found to be compliant with UN document ST/SG/AC.I0/11 Rev: 3: \"Amendments to the\nthird Revised Edition of the Recommendations on the Transport of Dangerous Goods, Manual of\nTests and Criteria'\"\n4. 5. The device contains no other materials subject to the HMR.\nThe batteries are fully contained in equipment and packaged in a manner to preclude sparks or\nthe generation of a dangerous quantity of heat.\nIf any additional information is required, please contact me via e-mail atkforgione@02-concepts.com.\n~IIY' ,VGiV .\nKathryn G~ione ~\nVice President of Quality\n02 Concepts, LLC\nCorporate: 14001 McAuley Blvd, Suite 170, Oklahoma City, OK 73134\nFactory: 15 Commerce Road, Newtown, CT 06470\nTelephone: 405.463.4950 • Toll Free: 877.867.4008 • Facsimile: 877.867.1314\n\n<<<PAGE 4>>>\n\n40156 Federal Register / Vol. 70, No. 132 / Tuesday, July 12, 2005 / Rules and Regulations\nDEPARTMENT OF TRANSPORTATION\nFederal Aviation Administration\n14 CFR Parts 11 and 121\n[Docket No.: FAA–2004–18596; SFAR No.\n106]\nRIN 2120–AI30\nUse of Certain Portable Oxygen\nConcentrator Devices Onboard Aircraft\nAGENCY: Federal Aviation\nAdministration (FAA), DOT.\nACTION: Final rule.\nSUMMARY: This Special Federal Aviation\nRegulation (SFAR) will permit\npassengers to use certain portable\noxygen concentrator (POC) devices on\naircraft, provided certain conditions in\nthis SFAR are satisfied. The SFAR\nincludes a POC preparation requirement\nfor carry-on baggage transport, and a\nbattery-packaging standard necessary for\nthe safe carriage of extra POC batteries\nin carry-on baggage. This rulemaking\naction is necessary to address the\ntravelling needs of people on oxygen\ntherapy.\nDATES: This SFAR becomes effective\nAugust 11, 2005.\nFOR FURTHER INFORMATION CONTACT:\nDavid L. Catey, Air Transportation\nDivision, AFS–200, Federal Aviation\nAdministration, 800 Independence\nAvenue SW., Washington, DC 20591;\ntelephone (202) 267–3732.\nSUPPLEMENTARY INFORMATION:\nAvailability of Rulemaking Documents\nYou can get an electronic copy using\nthe Internet by:\n(1) Searching the Department of\nTransportation’s electronic Docket\nManagement System (DMS) web page\n(http://dms.dot.gov/search);\n(2) Visiting the Office of Rulemaking’s\nweb page at http://www.faa.gov/avr/\narm/index.cfm; or\n(3) Accessing the Government\nPrinting Office’s web page at http://\nwww.access.gpo.gov/su_\ndocs/aces/\naces140.html.\nYou can also get a copy by submitting\na request to the Federal Aviation\nAdministration, Office of Rulemaking,\nARM–1, 800 Independence Avenue\nSW., Washington, DC 20591, or by\ncalling (202) 267–9680. Make sure to\nidentify the amendment number or\ndocket number of this rulemaking.\nAnyone is able to search the\nelectronic form of all comments\nreceived into any of our dockets by the\nname of the individual submitting the\ncomment (or signing the comment, if\nsubmitted on behalf of an association,\nbusiness, labor union, etc.). You may\nreview DOT’s complete Privacy Act\nstatement in the Federal Register\npublished on April 11, 2000 (Volume\n65, Number 70; Pages 19477–78) or you\nmay visit http://dms.dot.gov.\nSmall Business Regulatory Enforcement\nFairness Act\nThe Small Business Regulatory\nEnforcement Fairness Act (SBREFA) of\n1996 requires FAA to comply with\nsmall entity requests for information or\nadvice about compliance with statutes\nand regulations within its jurisdiction. If\nyou are a small entity and you have a\nquestion regarding this document, you\nmay contact its local FAA official, or the\nperson listed under FOR FURTHER\nINFORMATION CONTACT. You can find out\nmore about SBREFA on the Internet at\nhttp://www.faa.gov/avr/arm/sbrefa.cfm.\nAuthority for This Rulemaking\nThe FAA is authorized to issue this\npursuant to 49 U.S.C. 44701. Under that\nsection, the FAA is authorized to\nestablish regulations and minimum\nstandards for ‘‘other practices methods\nand procedure the Administrator finds\nnecessary for air commerce and national\nsecurity.’’\nBackground\nThis final rule responds to comments\nreceived on notice of proposed\nrulemaking (NPRM) titled ‘‘Use of\nPortable Oxygen Concentrator Devices\nOnboard Aircraft,’’ (69 FR 42324; July\n14, 2004). The NPRM proposed a\nSpecial Federal Aviation Regulation\n(SFAR) to allow passengers to operate\ncertain portable oxygen concentrator\n(POC) devices on aircraft if certain\nconditions detailed in the proposal were\nmet.\nAs stated in the NPRM, the FAA\nrecognizes that there is a critical need to\nimprove service for passengers who\nhave a medical need to travel with\nmedical oxygen. Passengers requiring\nmedical oxygen during air travel have\nfaced significant difficulties obtaining\nadequate air service. Many carriers do\nnot provide medical oxygen during air\ntravel. Those carriers that provide the\nservice often charge for the service—\nsometimes at a cost that equals the price\nof a ticket. Additionally, it can be\ndifficult to coordinate service between\nthe carrier and a supplier of medical\noxygen to ensure passenger coverage\nboth at the terminal and on the aircraft.\nSometimes, the passenger must spend at\nleast part of the time travelling without\nmedical oxygen due to service problems\nwith the oxygen provider.\nCompressed oxygen is regulated as a\nHazardous Material by the Pipeline and\nHazardous Materials Safety\nAdministration (PHMSA), formerly the\nResearch and Special Programs\nAdministration (RSPA), under title 49\nCFR 172.101. The FAA also regulates\noxygen furnished by aircraft operators to\npassengers who have a medical need for\noxygen on board the aircraft. Oxygen is\nhighly regulated because, as an oxidizer,\nit can enhance an existing fire, and it\ncan support combustion of certain\nflammable materials, whether or not an\nignition source is present. The FAA’s\nmedical oxygen regulations, 14 CFR\n121.574, 125.219, and 135.91, currently\nallow aircraft operators to furnish\nequipment for the storage, generation, or\ndispensing of oxygen to passengers\nprovided all of the following conditions\nare met:\nThe equipment is:\n1. Furnished by the certificate holder;\n2. Of an approved type or is in\nconformity with the manufacturing,\npackaging, marking, labelling and\nmaintenance requirements of 49 CFR\nparts 171, 172 and 173 except\n173.24(a)(1);\n3. Maintained by the aircraft operator\nin accordance with an approved\nmaintenance program;\n4. Free of flammable contaminants on\nall exterior surfaces;\n5. Capable of providing a minimum\nmass flow of oxygen to the user of four\nliters per minute (this provision is not\ncontained in either part 125 or 135\nregulations);\n6. Constructed so that all valves,\nfittings and gauges are protected from\ndamage; and\n7. Appropriately secured.\nRecently new medical oxygen\ntechnologies have been approved by the\nFood and Drug Administration that\nreduce the risks typically associated\nwith compressed oxygen. Two\ncompanies—AirSep Corporation and\nInogen, Inc.—have developed small\nPOCs that work by filtering out nitrogen\nfrom the air and providing the user with\noxygen at a concentration of about 90%.\nThe POCs operate using either\nrechargeable batteries or, if approved by\nthe FAA, aircraft electrical power.\nIn addition, PHMSA, formerly RSPA,\nhas determined that the POCs are not\nhazardous materials. Thus they do not\nrequire the same level of special\nhandling as compressed oxygen, and are\nsafe for use onboard aircraft provided\ncertain conditions for their use are met.\nSummary\nThis SFAR establishes requirements\napplicable to passenger-supplied POCs\nused on aircraft. With the adoption of\nthis rule, passengers will be able to\nchoose between two different kinds of\nVerDate jul<14>2003 15:38 Jul 11, 2005 Jkt 205001 PO 00000 Frm 00002 Fmt 4701 Sfmt 4700 E:\\FR\\FM\\12JYR2.SGM 12JYR2\n\n<<<PAGE 5>>>\n\nFederal Register / Vol. 70, No. 132 / Tuesday, July 12, 2005 / Rules and Regulations\n40157\nportable oxygen concentrator (POC)\ndevices to operate onboard an aircraft\nduring travel. The NPRM published in\nJuly 2004 explained the proposal and\nthis final rule adopts much of that\noriginal proposal, with some\nmodifications, including:\n1. Some proposed requirements that\nwould have been placed on air carriers\nare now the responsibility of the POC\nuser;\n2. The Inogen One POC, mentioned\nonly as being studied in the NPRM, is\nincluded as an eligible portable\nelectronic device in the SFAR in\nresponse to comments;\n3. We will allow passengers using a\nPOC to walk around the cabin while\ncarrying the device. However, when a\npassenger has a medical need to use a\nPOC during movement on the surface,\ntakeoff, and landing, the person using\nthe POC must be seated in seat location\nso as not to restrict other passenger’s\naccess to, or use of, any required\nemergency, or regular exit. Additionally,\nthe POC user must be seated in a\nlocation so as not to restrict access to\nthe aisle(s) of the passenger\ncompartment. Passengers who do not\nhave a medical need to use a POC\nduring movement on the surface, takeoff\nand landing, and are not seated in\naccordance with the preceding\nrequirements, must properly stow the\nPOC so it does not block access to the\naisleway (e.g., under the passenger seat\nin front of the user). In either case, POCs\nand the extra batteries needed to power\nthem must be properly stowed in\naccordance with the applicable carry-on\nbaggage requirements of 14 CFR 91.523,\n91.525, 121.285, 121.589, 125.183, and\n135.87.\n4. Several extra batteries may be\nrequired to power the POCs for some\nflights and we are including a battery-\npackaging standard for POC batteries\nincluded in carry-on baggage. (Section\n3(b)(6) of the SFAR)\nWe don’t feel that any of these\nmodifications go outside the scope of\nthe original NPRM since we specifically\ncited the Inogen One POC and sought\ncomment on who should be responsible\nfor certain aspects of the rule. All\ncomments are addressed below.\nThe SFAR is an enabling rule, which\nmeans that no aircraft operator is\nrequired to allow passengers to operate\nthese devices onboard, but they may\nallow them to be operated onboard. If an\naircraft operator chooses to allow a\npassenger to operate these devices\nonboard the aircraft operator’s aircraft\nthe conditions in the SFAR must be met.\nPresently, there are only two\nacceptable POCs on the market (Inogen\nand Airsep) and we cannot predict how\nfuture products may be developed and\nwork. Accordingly, while we are\ncommitted to developing a performance-\nbased standard for all future POC\ndevices, we do not want to prematurely\ndevelop standards that have the effect of\nstifling new technology of which we are\nunaware. It is only under exceptionally\nrare circumstances that the FAA would\npermit a specific product to be used in\na regulation. However, we believe such\nan approach is appropriate in this case\nuntil such time that a performance-\nbased standard can be developed\nbecause the rule accommodates\nindividuals who would otherwise be\nunable to fly. This approach is\nconsistent with the Department of\nTransportation’s desire to reduce travel\nbarriers to persons with disabilities.\nReference Material\nAfter reviewing the, ‘‘United Kingdom\nCivil Aviation Authority study titled\n‘‘Dealing With In-Flight Lithium Battery\nFires in Portable Electronic Devices’’\n,\nand recent incident data detailing\nbattery abuse and short circuit problems\nassociated with the carriage of batteries,\nit became clear that we must provide a\nmeans for reducing the hazard of\npersonal injury and fire from loose POC\nbatteries included as carry on items in\npassengers’ carry-on baggage. Although\nmost battery pack manufacturers\nemploy various protective devices to\nprevent abuse such as thermal or\npressure disconnects and shutdown\nseparators to prevent battery\noverheating and fires, abuse conditions\nsuch as physical damage to the cell(s) or\nexternal short circuits do occur. Abuse\nof the battery can cause those safeguards\nto become ineffective unless other\nprotective measures, such as battery\nouter protective packaging, are used.\n(See the discussion under the subtopic\nheading ‘‘Safety of Carrying Multiple\nBatteries’’ under the main topic heading\n‘‘Discussion of Comments’’ below).\nRelated Activity\nThe FAA’s Office of Security and\nHazardous Materials is coordinating\nwith the Office of Hazardous Materials\nSafety in the DOT’s Pipeline and\nHazardous Materials Safety\nAdministration (PHMSA) to examine\nbattery safety. More specifically,\nPHMSA is considering a rulemaking\nthat is aimed at preventing short circuit,\nsparking, and heat from all batteries and\nbattery-powered devices in\ntransportation. No formal or official\nrulemaking has begun at the time this\nSFAR is being published.\nDiscussion of Comments\nThe NPRM leading to this final rule\nwas published in the Federal Register\non July 14, 2004. We set a 30-day\ncomment period ending on August 13,\n2004. The Air Transport Association\n(ATA) requested that we extend the\ncomment period for an additional 60\ndays to allow more time to examine the\nproposal and submit appropriate\ncomment. After reviewing the ATA’s\nrequest, we determined that they\nmisunderstood the proposal and that\nsuch a significant extension would\nunnecessarily delay the final decision\non this rule. We extended the comment\nperiod an additional 15 days to allow\nadditional time to review and analyse\nthe proposal.\nThe new comment period closed on\nAugust 30, 2004. As of September 8,\n2004, we had received about 2,270\ncomments. All comments submitted\nafter the comment period closing date\nwere considered in this final rule.\nSupport for this proposed SFAR was\noverwhelming. Of the 2,270 comments,\n2,267 favored at least the spirit of our\nproposal. Commenters had many\nsubstantive and helpful comments that\nsuggested changes to our original\nproposal. Many of the comments were\nused to draft our Final Rule, a product\nthat benefits greatly from the thought\nand detail put into the comments.\nA large majority of the comments in\nfavor of our proposal were form letters\norganized by a number of interest\ngroups supporting the SFAR. We also\nreceived approximately 40 letters with\nextensive substantive comments,\nincluding questions, comments,\nsuggestions, and ideas. We are\nresponding to both the suggestions\nfound in the form letters, as well as the\nideas and suggestions found in the 40\nletters with extensive substantive\ncomments.\nWe asked for comments on the\nfollowing questions in the NPRM:\n1. Should the aircraft operator be\nrequired to inform the user about the\navailability of electrical outlets suitable\nfor the Airsep portable oxygen\nconcentrator?\n2. Should the user be required to carry\nbatteries for the duration of the flight\nincluding reasonable delays if there are\nelectrical outlets available on the flight?\n3. Are the meanings of the terms\n‘‘anticipated delay’’ and ‘‘reasonable\ndelay’’ sufficiently clear?\nQuestion 1. Use of Electrical Power\nPotential travellers commented in\nsupport of the aircraft operator\ninforming the travelling public of the\navailability of electrical outlets on board\nVerDate jul<14>2003 15:38 Jul 11, 2005 Jkt 205001 PO 00000 Frm 00003 Fmt 4701 Sfmt 4700 E:\\FR\\FM\\12JYR2.SGM 12JYR2\n\n<<<PAGE 6>>>\n\n40158 Federal Register / Vol. 70, No. 132 / Tuesday, July 12, 2005 / Rules and Regulations\naircraft. Potential travellers requiring\noxygen therapy stated that other\npassengers routinely plug a laptop\ncomputer or other entertainment device\ninto the aircraft’s power supply, so a\nPOC user should be given the same\nopportunity. Some commenters feel that\na POC user should be given priority over\nall users of other types of portable\nelectronic equipment.\nIn contrast, industry and air carrier\ncomments (including American Trans\nAir and the Air Transport Association)\nstrongly objected to informing\npassengers of the availability of\nelectrical outlets to power a POC. These\ncommenters stated that electrical outlets\nare not widely available on the aircraft\nand that a carrier cannot guarantee\naccess to an outlet because outlets may\nnot be available for a particular seat\nassignment or, aircraft without outlets\nmay be substituted unexpectedly for\naircraft with outlets. Additionally, these\ncommenters noted that some electrical\noutlets are designed to shut off\nautomatically if the aircraft experiences\nelectrical overload conditions. Any of\nthese scenarios would create a problem\nfor a POC user that had planned on\nusing the aircraft’s electrical supply and\nhad not brought an appropriate number\nof batteries. American Trans Air was\nconcerned with passengers being\nallowed to plug anything into the ship’s\npower because it could open a\n‘‘Pandora’s Box.’’\nFAA Response: The FAA agrees that\nif aircraft operators obtain FAA\nauthorization, access to the electrical\npower supply of the aircraft can be\nmade available for a POC user, but it is\nnot requiring the operator to inform the\npassenger about the availability of\nelectrical outlets. There are too many\nvariables that may change before the\nflight that could affect the availability of\nelectrical outlets. If carriers wish to\nprovide such information to potential\nPOC users it is their choice to do so. The\nFAA does not have the authority under\nthe Air Carrier Access Act to require\nsuch an action.\nIf, for example, an operator of a\ntransport category airplane provides a\npassenger access to aircraft electrical\npower for use with a POC, the operator\nmust ensure that the installation and\ncabling, up to the point where the\npassenger plugs in the POC, meets the\nairworthiness standards of 14 CFR\n25.1301, 25.1309, 25.1353, and 25.1357.\nThese sections ensure that the wiring\nand circuit protection are sufficient for\nthe intended use. The sections also\nensure that the POC will not negatively\naffect aircraft power.\nIn regard to the issue about giving\nPOC users priority to use any available\nelectrical outlets over people who are\nnot using POCs, the Department of\nTransportation (DOT), under the Air\nCarrier Access Act, would have to assess\nwhether the law requires a POC user to\nhave such priority access.\nQuestion 2 and 3. Number of Batteries\nin Carry-on To Address Anticipated or\nReasonable Delay\nIn the NPRM we asked whether the\nuser should be required to carry\nbatteries for the duration of the flight,\nincluding enough to cover reasonable\ndelays if there are electrical outlets\navailable on the flight. We also asked\nwhether the terms ‘‘anticipated delay’’\nand ‘‘reasonable delay’’ were\nsufficiently clear to a user to enable\nthem to make the decision as to how\nmany batteries would be needed.\nMost commenters felt that those terms\nwere not sufficient to determine the\nnumber of batteries that would be\nnecessary in the event of any type of\ndelay. Some suggested we simply\nrequire enough batteries to cover 150%\nof the flight time. Airbus commented\nthat the user should be responsible for\ncarrying the appropriate number of\nbatteries to cover for delays, even if\nthere are electrical outlets available on\nthe aircraft. Airbus specifically notes\nthat the outlets can only serve as backup\nfor the devices under certain conditions\nbecause they will not always be\navailable, and can be limited in power\nrating (typically around 75 Watts).\nFAA Response: The FAA does not\nbelieve that simply adding 150% to the\nscheduled flight time is adequate to\ncover the number of batteries that may\nbe needed by an oxygen dependent\npassenger. Flight time in the Official\nAirline Guides, for example, only\naccounts for the usual time between\naircraft pushback at the departure\nairport gate and the aircraft’s arrival at\nthe gate at the destination airport. It\ndoes not account for delays that occur\nafter passengers are boarded at the\ndeparture gate; after pushback from the\ndeparture gate but before takeoff; during\nin-flight holding at the arrival airport\nawaiting landing clearance; as a result of\nflight to a diversion airport due to either\nadverse weather conditions at the\nplanned destination airport or an\naircraft emergency; and after landing at\nthe planned destination airport.\nScheduled travel time then would not\nappear, in our eyes, to account for all\ncontingencies during travel. For\nexample, time spent on the ground prior\nto departure and while awaiting arrival\nat a gate can easily exceed an hour.\nWeather delays commonly exceed an\nhour if the weather conditions at the\ndeparture or planned destination\nairports cause air traffic instrument\nflight rules aircraft separation criteria to\nbe increased at peak airport departure\nand arrival times. Under the 150% flight\ntime increase comment, a 2 hour flight\nwould only require enough batteries to\npower the POC for 3 hours. Under that\nscenario, a weather delay of an hour\ncoupled with normal ground time,\ncould easily drain the battery power\nbefore the trip was completed.\nThe passenger’s physician can help\nthe passenger determine how much\noxygen the patient may need on a flight.\nThe physician, in the physician\nstatement, can note whether the\npassenger needs oxygen for the entire\nair travel time, including ground and in-\nflight delays, or only portions of those\ntimes. It is then up to the user to carry\nthe number of extra batteries necessary\nto cover the possible contingencies.\nGeneric Standard or Manufacturer\nSpecific\nMany commenters, including Inogen,\nInc., the Paralyzed Veterans of America,\nNational Home Oxygen Patients\nAssociation, and the American Thoracic\nSociety, requested that we not limit\nPOCs by specific brand or manufacturer.\nThese commenters wanted a generic\nstandard that would apply to different\ntypes of devices. Over 150 commenters,\nhowever, asked that if we did limit the\nPOC by manufacturer we include the\nInogen One POC in the SFAR. Overall,\nthere was broad support for writing a\nrule that would provide standards for a\nmanufacturer to meet in order to have\nan acceptable model of POC.\nFAA Response: As noted in the\nNPRM, the FAA was reviewing the\nInogen One POC and accompanying\nmaterial at the time of the NPRM’s\npublication. The FAA’s review and\nevaluation had to be completed prior to\ndetermining whether the Inogen One\nPOC would be eligible to be operated as\na POC, as well as a portable electronic\ndevice for use onboard aircraft. Since\nthe issuance of the NPRM, we have\ncompleted our review of the Inogen POC\nand we agree with commenters that the\nInogen One device is functionally\nsimilar to the AirSep POC and should\nbe included in the Final Rule. The FAA\nhas determined that this device may be\noperated onboard aircraft, subject to\ncertain conditions in the regulation, and\nthe SFAR will include this device along\nwith the Airsep Lifestyle POC.\nWe agree that future rulemaking\nshould include generic standards that\nfuture POC’s would be required to meet.\nSince this future rulemaking will\nrequire time to develop the standards,\nthe FAA will proceed, in the interim,\nwith this SFAR. This SFAR is the\nVerDate jul<14>2003 15:38 Jul 11, 2005 Jkt 205001 PO 00000 Frm 00004 Fmt 4701 Sfmt 4700 E:\\FR\\FM\\12JYR2.SGM 12JYR2\n\n<<<PAGE 7>>>\n\nFederal Register / Vol. 70, No. 132 / Tuesday, July 12, 2005 / Rules and Regulations\n40159\nquickest way to enable the use of these\ntwo devices by passengers who have a\nmedical need to continue to receive\noxygen therapy during their air travel.\nThe FAA will create a generic standard\nfor all POCs that will be the basis for a\nfollow-on rulemaking that will amend\n14 CFR permanently. This SFAR is\nintended to be the first step in allowing\npassenger-furnished POC devices to be\nused on aircraft.\nRole of FAA and RSPA (Now PHMSA)\nin Determining a Material ‘‘Hazardous’’\nSeveral commenters asked\nspecifically about a statement we\nincluded in the NPRM that pertained to\nthe review and approval process for\ndevices that may be considered non-\nhazardous by RSPA (now PHMSA) and\nwhether or not the FAA can overrule\nPHMSA on such a determination.\nFAA Response: The two steps in the\nprocess, while related, are not\nexclusively connected to one another. A\nPHMSA determination that a medical\noxygen device is not regulated as a\nhazardous material does not\nautomatically qualify such a device as\nsafe for use in air commerce. The FAA\nalso must review and evaluate the\ndevice to determine if there are any\nadditional safety concerns pertaining to\nthe use of the product on board an\naircraft. A ruling by the FAA that such\na device cannot be carried on board an\naircraft, however, does not mean that\nthe device is a hazardous material under\nPHMSA’s regulations in Title 49.\nRequiring Airlines To Permit the Use of\nPOCs\nAnother commenter requested that we\n‘‘require’’ aircraft operators to allow\npassengers needing oxygen therapy to\ncarry on and operate the POCs onboard\naircraft. The NPRM only stated that\noperators may choose to allow\npassengers on oxygen therapy to carry\non and operate the devices onboard\ntheir aircraft.\nFAA Response: The FAA does not\nhave the statutory authority under the\nAir Carrier Access Act to require air\ncarriers to allow these devices to be\ncarried or operated onboard their\naircraft. That authority is granted only\nto the Department of Transportation\n(DOT). It is DOT’s decision whether or\nnot to designate these devices as\nassistive devices, and to require air\ncarriers to allow the transport of these\ndevices and, in conjunction with the\nFAA, require air carriers to allow\npassenger operation of these devices\nonboard aircraft. This SFAR will open\nthe door for air carriers to take\nadvantage of the new market available\nthrough passenger use of these devices.\nUse of POCs During Takeoff and\nLanding and Passenger Movement in\nFlight\nCommenters wanted to make sure that\nour rule allowed passengers using a\nPOC to operate the device for the\nentirety of the flight if necessary. Many\noxygen users’ physicians may stipulate\nthat there is a medical need for their\npatients to use a POC during the entire\nflight, including movement on the\nsurface, takeoff, and landing. Movement\non the surface, takeoff, and landing are\ntimes when the current regulations\nrequire that, among other things,\nmedical oxygen equipment be properly\nstowed, and each person using the\nequipment to be seated at a seat location\nthat does not restrict passenger access\nto, or use of, any required exit\n(emergency or regular), or the aisle(s) in\nthe passenger compartment.\nFAA Response: This final rule will\nallow passengers to use a POC during\nthe flight, including movement on the\nsurface, takeoff, and landing.\nAdditionally, once passengers are\nallowed to move about the cabin of the\naircraft, they will be allowed to carry a\nPOC along with them. This allowance is\nspecifically cited in the new Section\n3(a)(6) in the regulatory text of this final\nrule.\nA new section was also included in\nthe regulatory text that requires the\nphysician statement to include\ninformation on the extent to which the\nuser must use the portable oxygen\nconcentrator (e.g., During takeoff and\nlanding only, during the whole flight,\nonly when needed, etc.)\nSafety of Carrying Multiple Batteries\nOne commenter raised concerns about\nthe safety of carrying multiple extra\nbatteries in carry-on baggage to be used\nto power the POC.\nFAA response: This commenter’s\nconcerns are shared by the FAA. We are\nadopting the requirement that\npassengers whose physician statement\nstipulates a medical need for extensive\noxygen use must carry enough extra\nbatteries to power the POC for the\nduration of time the passenger may be\non board the aircraft.\nComments received in response to the\nNPRM stated that the battery life for the\nAirSep Lifestyle POC is approximately\n50 minutes, while the Inogen One has\na battery life of approximately 2 to 3\nhours. Since the battery life for these\ndevices is so short, it is likely that\npassengers using these devices may\nhave to carry many extra batteries\nonboard the aircraft in order to comply\nwith their physician’s oxygen\nprescription. The number of extra\nbatteries must be able to power the POC\nin the event the aircraft operator does\nnot permit these devices to be powered\nby the aircraft electrical system, or the\naircraft electrical system is inoperative\nor otherwise unusable.\nTherefore, the FAA is including a new\nsection in the SFAR. Section 3(b)(6)\nrequires the user to ensure that all POC\nbatteries carried onboard aircraft as\ncarry-on baggage are protected from\nshort-circuit problems, and are\npackaged in a manner that protects them\nfrom physical damage. Protection from\nshort-circuit problems may be provided\nby batteries designed with recessed\nbattery terminals or by packaging that\nkeeps the battery terminals from\ncontacting metal objects (including the\nbattery terminals of other batteries).\nWhen a battery-powered oxygen\nconcentrator is carried onboard aircraft\nas carry-on baggage and is not intended\nto be used during flight, the battery\nmust be removed and packaged\nseparately, unless the concentrator\ncontains at least two effective protective\nfeatures to prevent accidental operation\nand battery overheating during\ntransport.\nThe passenger will be responsible for\nensuring that all extra batteries carried\nin carry-on baggage are properly\npackaged, but we do not envision\npassengers packaging the batteries\nthemselves.\nA POC manufacturer may not be able\nto develop a product to meet the\npackaging standard in this SFAR by the\ntime the rule becomes effective (30 days\nafter publication). However, the battery\npackaging standard contained in the\nregulatory language of this SFAR must\nbe met before the extra batteries will be\nallowed as carry-on baggage onboard the\naircraft. Companies with experience\nmeeting shipping standards will likely\nbe able to assist a passenger to meet this\nstandard.\nWe believe passengers can also\narrange for the following entities to\npackage extra POC batteries to meet the\nstandard:\n—Homecare providers;\n—Airlines;\n—Other entities specializing in small\npackage shipments.\nAs for the POC itself, we anticipate\nthe homecare provider would be able to\nprepare the device for transport.\nThere is a history of battery problems\nwith other portable electronic devices\nwhen a battery is being charged during\nflight. We currently do not have data to\nestablish a limit on the recharging of\nPOC batteries during flight. Therefore, if\nthe aircraft electrical system is available\nto recharge a POC battery, it is currently\npermissible to do so under this SFAR.\nVerDate jul<14>2003 15:38 Jul 11, 2005 Jkt 205001 PO 00000 Frm 00005 Fmt 4701 Sfmt 4700 E:\\FR\\FM\\12JYR2.SGM 12JYR2\n\n<<<PAGE 8>>>\n\n40160 Federal Register / Vol. 70, No. 132 / Tuesday, July 12, 2005 / Rules and Regulations\nIn the future, the FAA may consider\ndeveloping a technical standard order\n(TSO) to reduce the risk of overcharging\nfor certain types of rechargeable\nbatteries in portable electronic devices\nthat are carried in the aircraft passenger\ncompartment.\nBattery Backup for the POC in the\nEvent of Failure\nSome comments we received asked\nwhat sort of contingency or emergency\nprecautions would be taken if a POC\nwere to fail during the flight, or if\nbattery power ran out during the flight.\nThe American Association for\nRespiratory Care suggested that, if a\nPOC malfunctions, the flight crew\nshould provide the user access to\nsupplemental oxygen from the\nemergency oxygen source. The National\nHome Oxygen Patients Association also\nsupports the idea of consulting with the\npatient if a POC fails, and relying on the\nemergency medical oxygen that would\nbe available if an airline-provided\noxygen system were to fail. Access to\nthe aircraft’s emergency oxygen would\neliminate the need to divert the flight in\nmany instances.\nFAA Response: We agree that the\nappropriate action, in case of aircraft\nelectrical power or battery failure,\nwould be to refer to the passenger’s\nphysician statement and consult with\nthe passenger using the POC. The\ncrewmember should determine, through\nthe statement and discussion, the\nperson’s medical need for oxygen use\nand provide access to the aircraft’s first\naid oxygen equipment if necessary.\nHowever, it should be noted that only\naircraft required to be operated under 14\nCFR part 121 are required to be\nequipped with first aid oxygen\nequipment. We do not feel it is\nnecessary to include this particular\ndetail in this SFAR, but strongly\nencourage the aircraft operator to make\nthe availability of first aid oxygen\nequipment clear to the passengers who\nmay have a medical need for it. We also\nencourage passengers who have a\nmedical need for lengthy periods of\noxygen use to ensure that this\nequipment is available before arranging\nfor a flight.\nApplication of RTCA/DO–160D, Section\n21, Category M (Classified as a Medical-\nPortable Electronic Device)\nWe received comments with concern\nto section 3(a)(1) of the proposed rule\nthat required the aircraft operator to\nensure that a POC does not interfere\nwith electrical, navigation, or\ncommunication equipment on which\nthe device is being used. Several\ncommenters felt that this requirement\nmay mean that each aircraft operator\nhad to test each device for every model\nof aircraft they are flying to see if it is\nsafe. For instance, as the joint comment\nheaded by the American Thoracic\nSociety noted, the requirement would\nseem to mean that if U.S. Airways tested\nthe POC device on a Boeing 747 and\nfound that there was no interference,\nDelta Airlines would still have to test\nthe same device on the same model of\naircraft for themselves. The Air\nTransport Association echoed the\nquestion, and sought some answers\nabout whether or not the FAA’s\nAdvisory Circular (AC) 91.21–1A would\nbe applicable to a POC. If the POC were\ntested to the standard established for a\nmedical-portable oxygen device (M–\nPED) contained in RTCA Document\nDO–160D, would that be acceptable to\nmeet the requirement of section 3(a)(1)\nof the SFAR?\nFAA Response: A POC, whether it is\nthe Inogen One or the AirSep Lifestyle,\nis considered a medical-portable\nelectronic device (M–PED), and thus is\neligible to meet the standards contained\nin RTCA DO–160D. Both devices fall\nunder the scope of AC 91.21–1A, and\neach manufacturer can test their device\nto the standard called for in the AC. It\nmust be clear though that the\nrequirement found in section 3(a)(1)\nremains applicable to the aircraft\noperator. If a POC manufacturer tests the\ndevice to meet the RTCA standard and\nshows that it meets the standard, the\nmanufacturer may provide the positive\ntesting results to the aircraft operator on\nthe POC itself. The aircraft operator will\nhave to be able to show that the device\nhas been tested and meets the\napplicable standard regardless of the\ntest method used.\nIf either the Inogen or AirSep POC\nhave been tested to meet the RTCA\nstandard found in AC 91.21–1A, and the\ntest results are provided to, and verified\nby, the aircraft operator, no further\ntesting by the aircraft operator would be\nrequired.\nPOC as Carry on Baggage\nWe received comments from several\ninterested parties, including the\nAmerican Association for Respiratory\nCare, the American Thoracic Society,\nthe Pulmonary Hypertension\nAssociation, and others that requested\nwe allow passengers to bring two carry-\non bags if they are using a POC on the\nflight. Their recommendation would not\ninclude the POC itself as one of those\ncarry-on items, only the regular carry-on\nbaggage common for most travellers,\nand the extra batteries that will be\nnecessary for each flight.\nFAA Response: The FAA does not\nagree with the recommendations of the\ncommenters. Because aircraft operators’\naircraft passenger compartment\nconfigurations have differing capability\nto accommodate the safe stowage of\ndifferent sizes and amounts of carry-on\nbaggage, the FAA cannot simply\nestablish a requirement in its\nregulations that, henceforth, aircraft\noperators subject, for example to the\nrequirements of 14 CFR 121.589, must\nallow POC users to bring into the\npassenger compartment, two carry-on\nbags and the extra POC batteries in\naddition to their POC. The FAA’s\nregulations pertaining to the carriage of\ncarry-on baggage in passenger\ncompartments of aircraft, 14 CFR\n91.523, 91.525, 121.285, 121.589,\n125.183, and 135.87, provide that no\naircraft operator may allow the carriage\nof carry-on baggage on its aircraft unless\nthe applicable requirements prescribed\nby those regulations are met.\nThe FAA plans to provide\ninformation about the size and weight of\nthe POCs covered by this SFAR to\naircraft operators. This information may\ncause certain operators to review their\ncarry-on baggage programs to determine\nwhether they may be able to\naccommodate the carriage of the POCs.\nLiquid Oxygen Devices Onboard\nAircraft\nWe received several comments,\nmostly from individual commenters—\nnot from industry or interest groups,\nasking why we couldn’t also allow\npassengers to use the Helios liquid\noxygen device, or other","truncated":true,"body_characters":67355}