# OxySure Systems, Inc. — Hazardous Materials Safety Interpretation - **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:** Not available - **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:** <<>> U.S. Department of Transportation Pipeline and Hazardous Materials Safety Administration 1200 New Jersey Avenue, SE Washington, D.C. 20590 SEP 1 7 2008 Mr. John M. Lansdown Director of Research OxySure Systems, Inc. 10880 John W. Elliott Rd., Suite 600 Frisco, TX 75034 Ref. No. 08-0095 Dear Mr. Lansdown: This is in response to your letter and subsequent telephone conversations with members of my staff regarding the Hazardous Materials Regulations (HMR; 49 CFR 17 1 - 180) applicable to chemical oxygen generators. We apologize for the delay in responding and hope it has not caused any inconvenience. In your letter, you state that your company manufactures a portable chemical oxygen generator, the OxySure Model 61 5, which delivers medically pure oxygen for use in cardiovascular, respiratory, and general medical emergencies. You state the initiation of oxygen generation is via a mechanical mechanism which releases a plunger. The plunger breaks the internal seals, bringing the oxygen-producing powder and catalyst together in a "slurry." You state that the housing and most of the internal parts are injection-molded plastic, and oxygen is delivered via a latex-free tubing and mask assembly. You ask whether an approval is required for the transportation of your product. The answer is yes. As currently required in Special Provision 60, a chemical oxygen generator that is shipped with its means of initiation attached must incorporate at least two positive means of preventing unintentional actuation of the generator, and be classed and approved by the Associate Administrator. In addition, the HMR regulations pertaining to a chemical oxygen generator are applicable to your product, including, after October 1,2008, compliance with 4 173.168, which includes impact resistance, packaging, and marking requirements. I hope this satisfies your inquiry. Sincerely, Director Office of Hazardous Materials Standards <<>> oxysu April 15, Attention: h4r. Edward Mazzdo, Director Office of Hazatdous MaterkE Standards, PMI- 10 US. DOT/PHMSA Via DHL and F a c s d e : (202) 366-7435 Dear Mr. Mazzdlo, RE: EMERGENCY RELIEF PROM DOT HAZMAT REGULATIONS FOR FDA APPROVED PORTABLE OXYGEN GENERATOR We are s e e k an emergency interpxetarion by the Off ice of Hazardom Materials Srandards reg+ our consumer medical pmdua. We were direcred to the Standards Office by Ms. Harpreet SLrgh from the Office of Hazardous Materials Specla1 Permits and Approvak. We have developed a product that delivers medically pure OJSP) oxygen for use in cardiovascular, respiratory and general medical emergencies. The device is safe and easy to use, such that bystanders or laypersons can adminster medical oxygen ~JI an emergency while wairing for firs1 rzspondcrs to am? on the scene. T h e &vice, called the OxySwea Model 615 ms deemed safe enough LO have received FDA approval (510(K), Class 11) for Over-the-Counter sale to consumers. We are seeking emergency relief fmm the hazatdous materials shipping regulations as they rebte to uacttional chemical oxygen generators (49CFR 9172.200, $172.300, $172.400, §173.22,§173.56, $173.168,). These regulations are created to address the hazards associated with the chemical oxygen generaton traditionally used in cornmenial. aircraft. I have amched a copy of a letter addressed to the Permizs and A p p d office describing the OxySurea Model 615 Emergency Oxygen system and cont~asthg it to traditional chemical oxygen generators. I have also amched the MSDS for Model 615, Please do nut hesitate to contact me if p u need anyadchtional informarion. (Director of Research OXySwe System, Inc. Enclosures: Letter to PHMSA, Permits and Approvals - 10 Apr 2008 MSDS, 0q5uree Model 615 10880 Juhn Ekorr Rod, Suitc 600,F&co,'IX 75034 USA Frisco, Texas Office: (+I) 888-7CXYSURE Fw: (+I) 972-294-6501 v i Office: (+I) 703-687-1616 Fax: (+I) 703-580-7496 <<>> OxySure" Systems, Inc. US. DOT/PHMSA Office of Hazardous Materials Specbl Permits and Approvals, PHH-30 Via DHL, Facsimile: (202) 366-3308 and Email. phmsaapprovaJs@dot.gov Dear Sir/Madam, *Ihank you for your call yesterday and we are very pleased to learn that a revision to the regulations regarding chemical o m e n genenton may be imminent. We have a mksion- critical and time-critical need to get direction in this regard. Our technology is vasdy different to the old chlonte technology (for whrch the cumnt regulations is written) used in commercial aircraft, and was developed preciseky to e b t e the h a z d associated with it and orher, d t i o n a l oxygen delivery systems. In fact, our first product, the OxySureq Model 615 was deemed safe enough by the Food & Drug Administration to be approved for Over-the-Counter (OTCJ sale ro consumers as a Class I1 medical device (Approval number K052396). Background and Model 615 OxySure' Systems, Inc. spent the last 6 ~ a r s developing a next-generation technology for the delivery of medical o q e n through a safe chemical process. In the process, we have developed numerous patents on the technology Our f i t product based on this technology is a Portable Emergency Olrygen Generator called Model 615. Model 615 is indicated by the FDA to be used for emergency oxygen, usually in cardiac, respiratory ox other generaf medical emergencies. It is also well suited for applications in civil emergencies and other homeland security applications. The product is designed to pmvenr harm or possibly deah in emergency situations by provichg lifesaving o m e n , It is designed to be safe and simple to we, such that any bystander or layperson can administer medical oxygen while waiting for the f i t responders to amve on the scene. The OxySure@ Model 615 produces a minimum of 6 Liters per minute for a minimum of 15 minutes of medically p u t (USP) oxygen. This is the FDA standard for emergency oxygen, Model 615 was developed specifically to fill the need for a safe, easy to use portable oxygen source that did not have the risks associated wirh compressed gas cyh&rs, liquid oxygen, or the type of emergency oxygen source used in commercial aircrafr. Like a fire extinguisher, Model 615 can be safely pre-positioned in homes, buildings and other public and private s e w s to provide immedidte medical g d e oxygen in an emergency Model 615 has already been used in published cases where lives were saved b u g h its use, including rhc case of an 10880 John W E b t t RDd, Suite 600, Frisco, TX 75034 USA F~%co, Texas Office: (cl) 888-70XYSURE Fax (+I) 972-294-6501 VLtgjnia Office: (+I) 703-687-1616 Fax: (+I) 703-580-7496 <<>> eiernentay school child in South C m h . In January 2008 the OxySw@ Model 6 15 was named to the 2008 List of the World's Best Technologies. Technology The OxySure" Model 615 contains 3 components stond in separate hermetically sealed comparunenes: an inert, dry powder, which IS the oxygen source, a catalyst, and a Lquid, U& a compressed gas some, Model 615 does not contain a regulator, but rather produces oxygen at very close to atmospheric pressure. The initiation of oxygen generation is via a mechanical mechanism which leases a plastic plunger that breaks the k n a l seals bringing the oxygen producing powder and catalyst together in a slw T h e housing and most of rhe internal parts are injection- molded plastic. Lifesaving oxygen is delivered to the person in need via a laex-free tubing and mask assembly The chemicd component5 a x stored ins& a self-contained, dqosable cartridge.. The operating tempencures are much lower than traditional chemical oxygen generators and thus the device is not capable of ignitmg a fire. The device operates at very close to atmospheric pressure so it does not present the types of hazards represented by compressed gas cyhders or liquid oxygen. The device is not an explosion hazard. The chemicals are non toxic and envimnmentdy safe. Not a Temperature Hazard 'The OxySure" process results in oxygen generation at a temperanue much lower than traditional chemical oxygen generators used in commercd aircraft as PSUs, The outside swface of the unit only rises a few degrees F and the temperature of the oxygen produced increases typically only 5 tr, 10 degrees F above arnbient temperam, TypicaZly, the b r e a k temperam experienced by the user is less than 90" F. The temperanws within the sluny of the reacuon are typicaly in the 150°F range, well below h e temperam needed to initiate combusuon. O f come, the user 15 we1 insulated from the reaction core, such that the touch wmperanue of the cartridge is far less than that of a Starbucks coffee cup. Not an Exploeion Hazard The OxySure" Model 615 is not an explosion hazard. T h e oxygen generating process is initiated with the turn of a knob, causing the oxygen containing powder, catalyst and liquid to be instantly combined inside the caruidge. Prior to the reaction, the powders are dry and inert. Post-reacuon, the residue of the reaction consists of a harmless slurry. Therefore, Model 615 is not an explosion h a a d , either prior to the reanion or after. Funhexmore, we have completed several tesrs with Model 615 in the presence of a fire. We found that when the canridges are placed in a fire, the plastic components simply melt. Non-activated canridges placed in a fire melted, leasing the liquid in some cases. Even activated cartridges placed in a fire did not markedly enhance the activity of the f i , if at all. In swnrmry, Model 615 is not an explosion trazard, not undcr normal cixrurnsrances nor under the aggravated cirsumstances of a fire. Not a Toxicity Hazard The oxygen producing powder used in Model 615 does not represent a toxiciry hazard in the same way that, for example, the barium peroxide (used presently in commercial aircraft) repesents a toxicity hazard. From our MSDS p u will see that accidental contact with the <<>> - > - a mild skin r r r r lo, 2008 which can be d e v b ~ d by rinsing wirh powder produces no more water. Not an Environmental Hazard Upon accidental release due to the integrity of the c+e being broken, for exampIe, during shipment, the oxygen producing powder does not represent an environmental hazard. O n c e the cartridge is spent, it con& a slurry which is safe to dispose of regular household trash. Not a Pressure Hazard OxySureae Model 615 is a non-pressurized oxygen source. Oxygen gas is not stored in the caruidge but rahex produced upon activation. Under n o d operating condttions, the p~ssure within the system is well witkin 1 atm Pressure =lief valves az the top of each chamber prevent the caruidge from developing an internaI pressure higher than 1 am. in case of an accidental activation, ie., activation without the mask tubing attached. ?his is a summuy of the signhicant safety technologies incorporated into the OxjSure* Model 615 Emergency Oxygen synem. We would be delighted co provide all third party validations, test data and any other m a t e d you may require. In addition, the^ may be more helpful information on our wbsixe located ovwa.acpm.com, including an inswctiolul video showing how the product works. If p u have any questions or r e q k any additional information please do not hesitax to contact me or Julian Ross, President and CEO of OxySure" Systems, Inc. directly. Sincerely A r~irector of Resea~h OxySure' Systems, Inc. <<>> C Material Data Safely Sheet I Application of the product: Supplcmenfal Olrrygcn for Emergency Use Manufactu~r/Supplier OxySureQD Systems, Inc 10880 Jotur W. Elliott Drive, Surte 600 Frisco, TX 75034 Tel ; 8B8-7-OXYSURE Fiyr ; 972-294-6501 \rww.oxysure.com Emergency lnfor~nalion Call CHEMTREC 800-424-9300 (24 hrs) International 703-527.3 887 Molded Plastic; PWs: Primarily Polycarbonate and PClABS Polycwbonate 44% PCIABS 28% Starex ABS 12% Steel, Stainless Steel, Brass 4% Celcon, Polypropylene, Silicone, Nylon Celenex, Polyethylene, PVC, <2% EA ~ 1 % EA User Mask and Tubing: Latex Free Polyethylene Oxygen Producing Ingredients; OxySure@ Powder 60°h Accelerant 40% OxySure@ Catalyst 51% T X , I I the outer housing i s PCIABS J b e rnajo;cornpannt ofthe cwtt-idg;is polycrbonate I I I Gases and Fumes evolved during t h t thermal decomposition of this material may irritate the eyes, skin or respiratory trad. I Hazardous Materiels Identification System (IIMIS) Rating (scale 0 - 4): HEALTH: 0 PLAMMAB ILlTY. I REACTNITY: 0 SPECIAL HAZARD(S): I I As supplied, and under normal use, the oxygen-producin~ ingredients are self-contained in the cmidge, and user will not make any contact w~th the cartridge ingredients. However, if the cartridge contents spill out ss a result of accidental breakage of the cartridge: I 1 Avoid contact with skin and eyes and inhelation of any dust. I Hazardous Maicriels Identification System (HMIS) Rating (scale 0 - 4): HEALTFI* 2 FLAMMABILITY: 0 REACTFITY 1 National Fire Protection Association W P A ) Rating (scale 0 - 4) KEtUm: 2 FLAMMABILITY: 0 REACTIVITY: 1 I .;;\:I :: Y b! $-i)(,.ij,,\A %., :'3 <<>> urwertu ~nrurmmoon As supplied. and under normal use, this product consists of 6 crnridge andior a housing for the cent;dge. The maja component of the outer housin~ is PC/ABS. The major component of the cmridge is polycarbonate. The oxygen-producing inpdientr we self- contained in the cartridge. If the canridge contents spill out as a result of accidentd breakage of the rutridge: I I After inhalation of dust: Allow the victim to rest in a well ventilated area. Seek immediate medical attention. I Aftcr skin contact; Wash irnmcdiately with plenty o f water for 15 minutes. Remove contaminated clothing end shoes. Gently and thoroughly w a ~ h the coxlt~minated skin with running water and non-obrasivc soap. Be particularly careful to clean folds, crevices, creases and groin. Cover the imitated skin with an emollient. If initation persists, seek medical attention I 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 fingers. Check for and remove any contact lenses. Do not use an eye ointment. Seek medical attention. I wash ow mouth with water provided person is conscious. Seek medical attention. Water, Carbon dioxide (CO,), dry chemical, powder, or appropriate foam. Pmte~tivc equipment: Wear self-contained breathtng apparatus and protective clothing to prevent ageinn potentially toxic and irritating furncs and to avoid contact with skin and eyes. Unusual FireExplosion Hazards: Oxygen-generatmg device - the presence of oxygen can increase the rate and intensity of flame. Toxic and irritating gasedfumcs may be given offduring burning or thermol decomposition. If the cartridge contenrs spill out as a result of accidental breakage of the cartridge, contact may exacerbate an existing fire hazard. I I ;it I &; resht of sn accidental breakage of &e diastjc housing: I Avoid contact with skin and eyes and inhalation of any dust. Avoid contact of dry powder with combustible material. Use appropriate tools to put the spilled solid in a convenient waste disposal container. Avoid raieing dust. Finish cleaning by npreading water on the contaminated surfacc and disposc of according to local ar~d r q i o n d aurhority requiremenfs. Handling. Handle in accordance with good industrial hygiene and safay practices. Information about protection against explosions and fires: No special measures required Storage: Requirwncnts to be wet by s(ors rvvms and receptacles: Store at room temperature; 70°F to 86'F Store in cool, dry place. Do not attempt to open cadridge. \ [nformation about storage in one common Not required. storage facility: (2 1 "C to 30°C). Transportatioo: knditions: Temperature Limits During Lnw limit: 40°F (4%) High limit. 14g°F (6S°C) 'ransportation: If product is exposed to temperatures outside the transportetion exposure limits (lowet than 40°F or higher than 1.49TF), the cartridge nust be rep1ac;ed. \'!.)'!\? I \5.!?>> Additional information about design of technical N/A Components with limit values that require monitoring at the workplace: The product does not contain any relevant quantities of materials with critical values that have to be monitored at the workplace. If the cmidge content9 spill out as a result of accidental breakage ofthe cartridge: Personal protection equipment: Avoid contact with eyes and skin. Use compatible chemical-resistant gloves, chemical safety goggles. Remove md wash contaminated clothing. Discard contaminated shoes. 1.19-1.23 g/mL Insoluble Autoignition Temperature: NIA Molded PCIABS par@ Solid containing solid and liquid components Off white, gray, black N/ A Boiling poinurange: N/A Flash poin (PCIABS): 608°F (320°C) 1,ower Explosion Limit: Not Established Upper Exptosion Limit: Not Established Insoluble 900 OF (482°C) 53 1°F (277OC) 392°F (200°C) NIA Oxygen producing Ingredients: OxySure@ Powder Fonn Coarse Powder Appearance Free flowing white granular powder Color White pH l O . O * 1 BP/BP Rangc Nl A M P / M P Range NIA Freezing Point N/A Vapor Pressure N/A Vapor Density NIA Saturated Vapor Conc. NI A Bulk Density NIA Odor Threshold N/A Volatile% NIA (l~.!;~l!i,. I*,:.., t! t;:'; ,,:.I <<>> VOC Content N I A Water Content NIA Solvent Content N/ A Evaporation Retc N I A Viscosity NIA Surface Tension N/A Partition Cocffr~ient N/A Decomposition Temp. N l A Flesh Point N/A Explosion Linrils N/A Flammability N/A Autoignition Temp NIA Refractive Index N/A Optical. Rotation N l A Miscellaneous Data N/A Solubility N/ A K/A= Not Avzl:lal,lc: Hazardous polymerization does not occur Stable Materials to avoid: None known Conditions to avoid: None known By Fire and Thennal Decomposition: Hazardous deconryosition products Carbon Dioxide (C02); water; styrene; acrylonitrile; hydrngen cyanide; carbon monoxide, hydrocarbons Dangerous ptoducts of decomposition: Dangerous Reactioas: No dangerous decomposilion products known. As supplied, and under normal use. the oxygen-producing ingredients are self-contained in the camidge. If the cartridge contents spill out as a result of accidental. breakage of the cartridge: Marerials tu avoid: Strong reducing agents, strong acids, organic materials, salts of metals, flammable substances. Repeated Dose Toxicity; Rabbit, Draize, Non-irritating Rabbit, Slightly irritating Dermal: Non-sensitizer (Guinea pig, Buehler Test) 28 days, Oral: NOAEL: 1.862 mgkg (rat, MalelFemale, daily) Genetic Toxicity in Vitro: Ames: Negntivc rcsults were reported in various in vitro studics As supplied, and under normal use, the oxygen-producing ingredients are self-contained in the cartridge. If the cartridge contents lty 6 i :,.()I: .i:i() i i; \{i!v A '{! 1 . ) I ! ,? <<>> Dkctor of Research Dleclolmer; 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, expressly 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 st> 61 :.!llj-!)()Y,' ,I ;:I 2 !\7 <<>> h Routee of Entry: Acute Toxicity (oral): Eye contact. Jahalatiu~i. Ingestion LD50 1.9gkg - 3gkg Initation: Eye. skin, mucous membrane Not readily hiodegradable Bioaccu~rrulatioa: Does not bioaccumulate Acute and Prolonged Toxicity to Fish: LC50: 18 m g k (Common Carp (Cyprinus caprio, 96 hrs)) As supplied, and under normal use, the oxygen-producing ingredients are self-contained in the cartridge. I f the cartt.idgz conlrnts spill out as a result of accidental breakage of the cartridge: Kecornnendations: Product i s intended to supply medical oxygen for emergency use. FDA approval number K052396. As supplied, and under normal use, this product consists of a cartridge and/or a housing for the cartridge. The major component of the outer housing is PCIABS. The major component of the cartridge is polycarbonate. OSHA Hatcorn Standard Rating: Non-Hazardous US Toxic Substances Control Act: Listed on the TSCA Inventory US EPA cERCLA Hazardous Substances (40 CFR 302; Components): Nonc SAKA Section 3 1113 12 Hazard Categories: Non-hazardous under Section 3 1 113 12 US EPA Emergency Planning and Cornmuniry Right-To Know Act (EPCRA) SARA Title I11 Section 302 Extremely Hazardous S U ~ S ~ ~ C E (40 SCR 355, Appendix A; Components): None US EPA Emergency Planning and Community Right-To Know Act (EPCRA- SARA Title 111 Section 3 13 Toxic Chemicals (40 CFR 372.65) - Supplier Notification Required (Components): None US EPA Resource Conservation and Recovery Act (RCRA) Composite List of Hazardous Wastes and Appendix VTll 0's (;I z.(ll,;..!!i~:~ 1 : ~ s \;;4 :;1 - **truncated:** false - **body characters:** 20788