{"operation":"document","citation":"08-0095","title":"OxySure Systems, Inc. — Hazardous Materials Safety Interpretation","source_type":"guidance","agency":"Pipeline and Hazardous Materials Safety Administration","status":"guidance","official":true,"published_on":"2008-09-17","effective_on":null,"summary":"08-0095 response to OxySure Systems, Inc. concerning 173.168.","machine_formats":{"json":"https://regulus.evalyn.ai/document/phmsa-interpretation-08-0095.json","markdown":"https://regulus.evalyn.ai/document/phmsa-interpretation-08-0095.md"},"app_url":"https://regulus.evalyn.ai/document/phmsa-interpretation-08-0095","source_url":"https://www.phmsa.dot.gov/sites/phmsa.dot.gov/files/legacy/interpretations/Interpretation%20Files/2008/080095.pdf","body":"<<<PAGE 1>>>\n\nU.S. Department\nof Transportation\nPipeline and Hazardous\nMaterials Safety\nAdministration\n1200 New Jersey Avenue, SE\nWashington, D.C. 20590\nSEP 1 7 2008\nMr. John M. Lansdown\nDirector of Research\nOxySure Systems, Inc.\n10880 John W. Elliott Rd., Suite 600\nFrisco, TX 75034\nRef. No. 08-0095\nDear Mr. Lansdown:\nThis is in response to your letter and subsequent telephone conversations with members of my\nstaff regarding the Hazardous Materials Regulations (HMR; 49 CFR 17 1 - 180) applicable to\nchemical oxygen generators. We apologize for the delay in responding and hope it has not\ncaused any inconvenience.\nIn your letter, you state that your company manufactures a portable chemical oxygen generator,\nthe OxySure Model 61 5, which delivers medically pure oxygen for use in cardiovascular,\nrespiratory, and general medical emergencies. You state the initiation of oxygen generation is\nvia a mechanical mechanism which releases a plunger. The plunger breaks the internal seals,\nbringing the oxygen-producing powder and catalyst together in a \"slurry.\" You state that the\nhousing and most of the internal parts are injection-molded plastic, and oxygen is delivered via a\nlatex-free tubing and mask assembly. You ask whether an approval is required for the\ntransportation of your product.\nThe answer is yes. As currently required in Special Provision 60, a chemical oxygen generator\nthat is shipped with its means of initiation attached must incorporate at least two positive means\nof preventing unintentional actuation of the generator, and be classed and approved by the\nAssociate Administrator. In addition, the HMR regulations pertaining to a chemical oxygen\ngenerator are applicable to your product, including, after October 1,2008, compliance with\n4 173.168, which includes impact resistance, packaging, and marking requirements.\nI hope this satisfies your inquiry.\nSincerely,\nDirector\nOffice of Hazardous Materials Standards\n\n<<<PAGE 2>>>\n\noxysu\nApril 15,\nAttention: h4r. Edward Mazzdo, Director\nOffice of Hazatdous MaterkE Standards, PMI- 10\nUS. DOT/PHMSA\nVia DHL and F a c s d e : (202) 366-7435\nDear Mr. Mazzdlo,\nRE: EMERGENCY RELIEF PROM DOT HAZMAT REGULATIONS FOR\nFDA APPROVED PORTABLE OXYGEN GENERATOR\nWe are s e e k an emergency interpxetarion by the Off ice of Hazardom Materials Srandards\nreg+ our consumer medical pmdua. We were direcred to the Standards Office by Ms.\nHarpreet SLrgh from the Office of Hazardous Materials Specla1 Permits and Approvak.\nWe have developed a product that delivers medically pure OJSP) oxygen for use in\ncardiovascular, respiratory and general medical emergencies. The device is safe and easy to\nuse, such that bystanders or laypersons can adminster medical oxygen ~JI an emergency\nwhile wairing for firs1 rzspondcrs to am? on the scene. T h e &vice, called the OxySwea\nModel 615 ms deemed safe enough LO have received FDA approval (510(K), Class 11) for\nOver-the-Counter sale to consumers.\nWe are seeking emergency relief fmm the hazatdous materials shipping regulations as they\nrebte to uacttional chemical oxygen generators (49CFR 9172.200, $172.300, $172.400,\n§173.22,§173.56, $173.168,). These regulations are created to address the hazards associated\nwith the chemical oxygen generaton traditionally used in cornmenial. aircraft. I have\namched a copy of a letter addressed to the Permizs and A p p d office describing the\nOxySurea Model 615 Emergency Oxygen system and cont~asthg it to traditional chemical\noxygen generators. I have also amched the MSDS for Model 615,\nPlease do nut hesitate to contact me if p u need anyadchtional informarion.\n(Director of Research\nOXySwe System, Inc.\nEnclosures: Letter to PHMSA, Permits and Approvals - 10 Apr 2008\nMSDS, 0q5uree Model 615\n10880 Juhn Ekorr Rod, Suitc 600,F&co,'IX 75034 USA\nFrisco, Texas Office: (+I) 888-7CXYSURE Fw: (+I) 972-294-6501\nv i Office: (+I) 703-687-1616 Fax: (+I) 703-580-7496\n\n<<<PAGE 3>>>\n\nOxySure\" Systems, Inc.\nUS. DOT/PHMSA\nOffice of Hazardous Materials Specbl Permits and Approvals, PHH-30\nVia DHL, Facsimile: (202) 366-3308 and Email. phmsaapprovaJs@dot.gov\nDear Sir/Madam,\n*Ihank you for your call yesterday and we are very pleased to learn that a revision to the\nregulations regarding chemical o m e n genenton may be imminent. We have a mksion-\ncritical and time-critical need to get direction in this regard.\nOur technology is vasdy different to the old chlonte technology (for whrch the cumnt\nregulations is written) used in commercial aircraft, and was developed preciseky to e b t e\nthe h a z d associated with it and orher, d t i o n a l oxygen delivery systems. In fact, our first\nproduct, the OxySureq Model 615 was deemed safe enough by the Food & Drug\nAdministration to be approved for Over-the-Counter (OTCJ sale ro consumers as a Class I1\nmedical device (Approval number K052396).\nBackground and Model 615\nOxySure' Systems, Inc. spent the last 6 ~ a r s developing a next-generation technology for\nthe delivery of medical o q e n through a safe chemical process. In the process, we have\ndeveloped numerous patents on the technology\nOur f i t product based on this technology is a Portable Emergency Olrygen Generator\ncalled Model 615. Model 615 is indicated by the FDA to be used for emergency oxygen,\nusually in cardiac, respiratory ox other generaf medical emergencies. It is also well suited for\napplications in civil emergencies and other homeland security applications. The product is\ndesigned to pmvenr harm or possibly deah in emergency situations by provichg lifesaving\no m e n , It is designed to be safe and simple to we, such that any bystander or layperson can\nadminister medical oxygen while waiting for the f i t responders to amve on the scene.\nThe OxySure@ Model 615 produces a minimum of 6 Liters per minute for a minimum of 15\nminutes of medically p u t (USP) oxygen. This is the FDA standard for emergency oxygen,\nModel 615 was developed specifically to fill the need for a safe, easy to use portable oxygen\nsource that did not have the risks associated wirh compressed gas cyh&rs, liquid oxygen, or\nthe type of emergency oxygen source used in commercial aircrafr. Like a fire extinguisher,\nModel 615 can be safely pre-positioned in homes, buildings and other public and private\ns e w s to provide immedidte medical g d e oxygen in an emergency Model 615 has already\nbeen used in published cases where lives were saved b u g h its use, including rhc case of an\n10880 John W E b t t RDd, Suite 600, Frisco, TX 75034 USA\nF~%co, Texas Office: (cl) 888-70XYSURE Fax (+I) 972-294-6501\nVLtgjnia Office: (+I) 703-687-1616 Fax: (+I) 703-580-7496\n\n<<<PAGE 4>>>\n\neiernentay school child in South C m h . In January 2008 the OxySw@ Model 6 15 was\nnamed to the 2008 List of the World's Best Technologies.\nTechnology\nThe OxySure\" Model 615 contains 3 components stond in separate hermetically sealed\ncomparunenes: an inert, dry powder, which IS the oxygen source, a catalyst, and a Lquid,\nU& a compressed gas some, Model 615 does not contain a regulator, but rather\nproduces oxygen at very close to atmospheric pressure. The initiation of oxygen generation\nis via a mechanical mechanism which leases a plastic plunger that breaks the k n a l seals\nbringing the oxygen producing powder and catalyst together in a slw T h e housing and\nmost of rhe internal parts are injection- molded plastic. Lifesaving oxygen is delivered to the\nperson in need via a laex-free tubing and mask assembly\nThe chemicd component5 a x stored ins& a self-contained, dqosable cartridge.. The\noperating tempencures are much lower than traditional chemical oxygen generators and thus\nthe device is not capable of ignitmg a fire. The device operates at very close to atmospheric\npressure so it does not present the types of hazards represented by compressed gas cyhders\nor liquid oxygen. The device is not an explosion hazard. The chemicals are non toxic and\nenvimnmentdy safe.\nNot a Temperature Hazard\n'The OxySure\" process results in oxygen generation at a temperanue much lower than\ntraditional chemical oxygen generators used in commercd aircraft as PSUs, The outside\nswface of the unit only rises a few degrees F and the temperature of the oxygen produced\nincreases typically only 5 tr, 10 degrees F above arnbient temperam, TypicaZly, the b r e a k\ntemperam experienced by the user is less than 90\" F. The temperanws within the sluny of\nthe reacuon are typicaly in the 150°F range, well below h e temperam needed to initiate\ncombusuon. O f come, the user 15 we1 insulated from the reaction core, such that the touch\nwmperanue of the cartridge is far less than that of a Starbucks coffee cup.\nNot an Exploeion Hazard\nThe OxySure\" Model 615 is not an explosion hazard. T h e oxygen generating process is\ninitiated with the turn of a knob, causing the oxygen containing powder, catalyst and liquid\nto be instantly combined inside the caruidge. Prior to the reaction, the powders are dry and\ninert. Post-reacuon, the residue of the reaction consists of a harmless slurry. Therefore,\nModel 615 is not an explosion h a a d , either prior to the reanion or after.\nFunhexmore, we have completed several tesrs with Model 615 in the presence of a fire. We\nfound that when the canridges are placed in a fire, the plastic components simply melt.\nNon-activated canridges placed in a fire melted, leasing the liquid in some cases. Even\nactivated cartridges placed in a fire did not markedly enhance the activity of the f i , if at all.\nIn swnrmry, Model 615 is not an explosion trazard, not undcr normal cixrurnsrances nor\nunder the aggravated cirsumstances of a fire.\nNot a Toxicity Hazard\nThe oxygen producing powder used in Model 615 does not represent a toxiciry hazard in the\nsame way that, for example, the barium peroxide (used presently in commercial aircraft)\nrepesents a toxicity hazard. From our MSDS p u will see that accidental contact with the\n\n<<<PAGE 5>>>\n\n- > - a mild skin r r r r lo, 2008\nwhich can be d e v b ~ d by rinsing wirh\npowder produces no more water.\nNot an Environmental Hazard\nUpon accidental release due to the integrity of the c+e being broken, for exampIe,\nduring shipment, the oxygen producing powder does not represent an environmental hazard.\nO n c e the cartridge is spent, it con& a slurry which is safe to dispose of regular\nhousehold trash.\nNot a Pressure Hazard\nOxySureae Model 615 is a non-pressurized oxygen source. Oxygen gas is not stored in the\ncaruidge but rahex produced upon activation. Under n o d operating condttions, the\np~ssure within the system is well witkin 1 atm Pressure =lief valves az the top of each\nchamber prevent the caruidge from developing an internaI pressure higher than 1 am. in\ncase of an accidental activation, ie., activation without the mask tubing attached.\n?his is a summuy of the signhicant safety technologies incorporated into the OxjSure*\nModel 615 Emergency Oxygen synem. We would be delighted co provide all third party\nvalidations, test data and any other m a t e d you may require. In addition, the^ may be more\nhelpful information on our wbsixe located ovwa.acpm.com, including an inswctiolul\nvideo showing how the product works.\nIf p u have any questions or r e q k any additional information please do not hesitax to\ncontact me or Julian Ross, President and CEO of OxySure\" Systems, Inc. directly.\nSincerely A\nr~irector of Resea~h\nOxySure' Systems, Inc.\n\n<<<PAGE 6>>>\n\nC\nMaterial Data Safely Sheet\nI Application of the product: Supplcmenfal Olrrygcn for Emergency Use\nManufactu~r/Supplier OxySureQD Systems, Inc\n10880 Jotur W. Elliott Drive, Surte 600\nFrisco, TX 75034\nTel ; 8B8-7-OXYSURE\nFiyr ; 972-294-6501\n\\rww.oxysure.com\nEmergency lnfor~nalion Call CHEMTREC 800-424-9300 (24 hrs)\nInternational 703-527.3 887\nMolded Plastic; PWs:\nPrimarily Polycarbonate and PClABS\nPolycwbonate 44%\nPCIABS 28%\nStarex ABS 12%\nSteel, Stainless Steel, Brass 4%\nCelcon, Polypropylene, Silicone, Nylon Celenex, Polyethylene, PVC, <2% EA\n~ 1 % EA\nUser Mask and Tubing:\nLatex Free Polyethylene\nOxygen Producing Ingredients; OxySure@ Powder 60°h\nAccelerant 40%\nOxySure@ Catalyst 51%\nT X ,\nI I the outer housing i s PCIABS J b e rnajo;cornpannt ofthe cwtt-idg;is polycrbonate I\nI I Gases and Fumes evolved during t h t thermal decomposition of this material may irritate the eyes, skin or respiratory trad. I\nHazardous Materiels Identification System (IIMIS) Rating (scale 0 - 4):\nHEALTH: 0\nPLAMMAB ILlTY. I\nREACTNITY: 0\nSPECIAL HAZARD(S):\nI I As supplied, and under normal use, the oxygen-producin~ ingredients are self-contained in the cmidge, and user will not make any\ncontact w~th the cartridge ingredients. However, if the cartridge contents spill out ss a result of accidental breakage of the cartridge:\nI 1 Avoid contact with skin and eyes and inhelation of any dust. I\nHazardous Maicriels Identification System (HMIS) Rating (scale 0 - 4):\nHEALTFI* 2\nFLAMMABILITY: 0\nREACTFITY 1\nNational Fire Protection Association W P A ) Rating (scale 0 - 4)\nKEtUm: 2\nFLAMMABILITY: 0\nREACTIVITY: 1 I\n.;;\\:I ::\nY b! $-i)(,.ij,,\\A %., :'3\n\n<<<PAGE 7>>>\n\nurwertu ~nrurmmoon\nAs supplied. and under normal use, this product consists of 6 crnridge andior a housing for the cent;dge. The maja component of\nthe outer housin~ is PC/ABS. The major component of the cmridge is polycarbonate. The oxygen-producing inpdientr we self-\ncontained in the cartridge. If the canridge contents spill out as a result of accidentd breakage of the rutridge:\nI I After inhalation of dust: Allow the victim to rest in a well ventilated area. Seek immediate medical attention. I\nAftcr skin contact; Wash irnmcdiately with plenty o f water for 15 minutes. Remove contaminated clothing end shoes.\nGently and thoroughly w a ~ h the coxlt~minated skin with running water and non-obrasivc soap. Be\nparticularly careful to clean folds, crevices, creases and groin. Cover the imitated skin with an emollient.\nIf initation persists, seek medical attention\nI I After eye contact: ( [ AAer swallow in^: 1 I Suitable extinguishing agents: Flush eyes with plenty of water for 1.5 minutes. Assure adequate flushing by separating the eyelids with\nfingers. Check for and remove any contact lenses. Do not use an eye ointment. Seek medical attention. I\nwash ow mouth with water provided person is conscious. Seek medical attention.\nWater, Carbon dioxide (CO,), dry chemical, powder, or appropriate foam.\nPmte~tivc equipment: Wear self-contained breathtng apparatus and protective clothing to prevent\nageinn potentially toxic and irritating furncs and to avoid contact with skin\nand eyes.\nUnusual FireExplosion Hazards: Oxygen-generatmg device - the presence of oxygen can increase the rate and\nintensity of flame. Toxic and irritating gasedfumcs may be given offduring\nburning or thermol decomposition. If the cartridge contenrs spill out as a\nresult of accidental breakage of the cartridge, contact may exacerbate an\nexisting fire hazard.\nI I ;it I\n&; resht of sn accidental breakage of &e diastjc housing: I\nAvoid contact with skin and eyes and inhalation of any dust. Avoid contact of dry powder with combustible material. Use\nappropriate tools to put the spilled solid in a convenient waste disposal container. Avoid raieing dust. Finish cleaning by npreading\nwater on the contaminated surfacc and disposc of according to local ar~d r q i o n d aurhority requiremenfs.\nHandling.\nHandle in accordance with good industrial hygiene and safay practices.\nInformation about protection against explosions and fires:\nNo special measures required\nStorage:\nRequirwncnts to be wet by s(ors rvvms and receptacles: Store at room temperature; 70°F to 86'F Store in cool, dry place.\nDo not attempt to open cadridge.\n\\ [nformation about storage in one common Not required.\nstorage facility:\n(2 1 \"C to 30°C).\nTransportatioo:\nknditions: Temperature Limits During Lnw limit: 40°F (4%) High limit. 14g°F (6S°C)\n'ransportation:\nIf product is exposed to temperatures outside the transportetion exposure limits (lowet\nthan 40°F or higher than 1.49TF), the cartridge nust be rep1ac;ed.\n\\'!.)'!\\?\nI \\5.!?<lr!'$ !() I<<\" ,a -\n\n<<<PAGE 8>>>\n\nAdditional information about design of technical N/A\nComponents with limit values that require monitoring at the workplace: The product does not contain any relevant quantities of materials with critical\nvalues that have to be monitored at the workplace.\nIf the cmidge content9 spill out as a result of accidental breakage ofthe cartridge:\nPersonal protection equipment:\nAvoid contact with eyes and skin. Use compatible chemical-resistant gloves,\nchemical safety goggles. Remove md wash contaminated clothing. Discard\ncontaminated shoes.\n1.19-1.23 g/mL\nInsoluble\nAutoignition Temperature: NIA\nMolded PCIABS par@\nSolid containing solid and liquid components\nOff white, gray, black\nN/ A\nBoiling poinurange: N/A\nFlash poin (PCIABS): 608°F (320°C)\n1,ower Explosion Limit: Not Established\nUpper Exptosion Limit: Not Established\nInsoluble\n900 OF (482°C)\n53 1°F (277OC)\n392°F (200°C)\nNIA\nOxygen producing Ingredients: OxySure@ Powder\nFonn Coarse Powder\nAppearance Free flowing white granular powder\nColor White\npH l O . O * 1\nBP/BP Rangc Nl A\nM P / M P Range NIA\nFreezing Point N/A\nVapor Pressure N/A\nVapor Density NIA\nSaturated Vapor Conc. NI A\nBulk Density NIA\nOdor Threshold N/A\nVolatile% NIA\n(l~.!;~l!i,. I*,:.., t! t;:'; ,,:.I\n\n<<<PAGE 9>>>\n\nVOC Content N I A\nWater Content NIA\nSolvent Content N/ A\nEvaporation Retc N I A\nViscosity NIA\nSurface Tension N/A\nPartition Cocffr~ient N/A\nDecomposition Temp. N l A\nFlesh Point N/A\nExplosion Linrils N/A\nFlammability N/A\nAutoignition Temp NIA\nRefractive Index N/A\nOptical. Rotation N l A\nMiscellaneous Data N/A\nSolubility N/ A\nK/A= Not Avzl:lal,lc:\nHazardous polymerization does not occur\nStable\nMaterials to avoid: None known\nConditions to avoid: None known\nBy Fire and Thennal Decomposition: Hazardous deconryosition products\nCarbon Dioxide (C02); water; styrene; acrylonitrile; hydrngen cyanide;\ncarbon monoxide, hydrocarbons\nDangerous ptoducts of decomposition: Dangerous Reactioas:\nNo dangerous decomposilion products known.\nAs supplied, and under normal use. the oxygen-producing ingredients are self-contained in the camidge. If the cartridge contents\nspill out as a result of accidental. breakage of the cartridge:\nMarerials tu avoid: Strong reducing agents, strong acids, organic materials, salts of metals,\nflammable substances.\nRepeated Dose Toxicity; Rabbit, Draize, Non-irritating\nRabbit, Slightly irritating\nDermal: Non-sensitizer (Guinea pig, Buehler Test)\n28 days, Oral: NOAEL: 1.862 mgkg (rat, MalelFemale, daily)\nGenetic Toxicity in Vitro: Ames: Negntivc rcsults were reported in various in vitro studics\nAs supplied, and under normal use, the oxygen-producing ingredients are self-contained in the cartridge. If the cartridge contents\nlty 6 i :,.()I: .i:i() i i; \\{i!v A '{! 1 . ) I ! ,?\n\n<<<PAGE 10>>>\n\nDkctor of Research\nDleclolmer; To o w knowledge, the information contained henln IS accurate as o f h e date of th~r document Howcvcr, OxySurc Systems, Inc , docs not warrant,\nexpressly or impliedly, or accept any lisbillcy in connecrlon wich r h ~ s information or Its use Thls InFometlon is f o r use by technically skilled persons at the11 own\nst> 61 :.!llj-!)()Y,' ,I ;:I 2 !\\7\n\n<<<PAGE 11>>>\n\nh\nRoutee of Entry: Acute Toxicity (oral): Eye contact. Jahalatiu~i. Ingestion\nLD50 1.9gkg - 3gkg\nInitation: Eye. skin, mucous membrane\nNot readily hiodegradable\nBioaccu~rrulatioa: Does not bioaccumulate\nAcute and Prolonged Toxicity to Fish: LC50: 18 m g k (Common Carp (Cyprinus caprio, 96 hrs))\nAs supplied, and under normal use, the oxygen-producing ingredients are self-contained in the cartridge. I f the cartt.idgz conlrnts\nspill out as a result of accidental breakage of the cartridge:\nKecornnendations:\nProduct i s intended to supply medical oxygen for emergency use. FDA approval number K052396.\nAs supplied, and under normal use, this product consists of a cartridge and/or a housing for the cartridge. The major component of\nthe outer housing is PCIABS. The major component of the cartridge is polycarbonate.\nOSHA Hatcorn Standard Rating: Non-Hazardous\nUS Toxic Substances Control Act: Listed on the TSCA Inventory\nUS EPA cERCLA Hazardous Substances (40 CFR 302; Components): Nonc\nSAKA Section 3 1113 12 Hazard Categories: Non-hazardous under Section 3 1 113 12\nUS EPA Emergency Planning and Cornmuniry Right-To Know Act (EPCRA) SARA Title I11 Section 302\nExtremely Hazardous S U ~ S ~ ~ C E (40 SCR 355, Appendix A; Components): None\nUS EPA Emergency Planning and Community Right-To Know Act (EPCRA- SARA Title 111 Section 3 13\nToxic Chemicals (40 CFR 372.65) - Supplier Notification Required (Components): None\nUS EPA Resource Conservation and Recovery Act (RCRA) Composite List of Hazardous Wastes and Appendix VTll\n0's (;I z.(ll,;..!!i~:~ 1 : ~ s \\;;4 :;1","truncated":false,"body_characters":20788}