{"operation":"document","citation":"03-0303","title":"Nene Labs — Hazardous Materials Safety Interpretation","source_type":"guidance","agency":"Pipeline and Hazardous Materials Safety Administration","status":"guidance","official":true,"published_on":"2004-05-11","effective_on":null,"summary":"03-0303 response to Nene Labs concerning 173.22.","machine_formats":{"json":"https://regulus.evalyn.ai/document/phmsa-interpretation-03-0303.json","markdown":"https://regulus.evalyn.ai/document/phmsa-interpretation-03-0303.md"},"app_url":"https://regulus.evalyn.ai/document/phmsa-interpretation-03-0303","source_url":"https://www.phmsa.dot.gov/sites/phmsa.dot.gov/files/legacy/interpretations/Interpretation%20Files/2003/030303.pdf","body":"<<<PAGE 1>>>\n\nof Transportation\nU.S. Department\n400 Seventh St., S.W.\nWashington, D.C. 20590\nResearch and\nspecial Programs\nAdministration\nMAY 1 1 2004\nMr. Jeff Jerome\nRef. No.: 03-0303\nCEO - Nene Labs\n5115 Gage\nBoise, Idaho 83706\nDear Mr. Jerome:\nThis responds to your letter regarding the classification and shipment of a portable \"OX-GEN Flexible\n02 Generation System, Model 6-0X-03,\" containing a water solution of approximately 7.5 % hydrogen\nperoxide by weight and manganese oxide, as a catalyst, in accordance with the Hazardous Materials\nRegulations (HMR; 49 CFR Parts 171-180). The OX-GEN Flexible 02 Generation System is\nintended to produce oxygen for emergency uses. The OX-GEN Flexible 02 Generation System\ndelivers over 8 liters per minute of 99% pure oxygen for a minimum of 15 minutes by means of a\nfollows:\nchemical reaction. The portable oxygen generator system is composed of two parts, described as\nThe reaction vessel consists of a plastic bag, with two chambers separated by a weak\nseal. The weak seal is welded plastic which breaks at about 10 pounds of pressure\nachieved by squeezing the bag toward the weak seal. The bag contains an outlet of\nchemically non-reactive tygon tubing attached to the hydrophobic filter. The bag\n(reaction vessel) reached a maximum average pressure of 4.2 Ibs/psi. The hydrophobic\nfilter is not reactive with hydrogen peroxide or oxygen, and allows O2 (oxygen) gas to\npass, but no liquid, and leads to a standard oxygen mask.\nThe chemicals in the reaction vessel consists of a water solution of approximately 7.5%\nH,Oz (hydrogen peroxide) by weight in one chamber, and a small amount of MnO,\n(manganese dioxide) in the smaller chamber. The MinOz is a catalyst in the reaction,\nand liberates one of the oxygen molecules from the Hl,Oz, yielding H2O (water) and O2\n(oxygen). Since the reaction is exothermic, heat is generated. At the end of the\nreaction, the temperature of the reactants is approximately 68°C - 72°C. The\nmaximum temperature of the O½ at the end of the reaction is 32°C - 34°C. After the\nreaction is complete (less than 20 minutes), the entire apparatus is thrown away. The\nfinal by-products at the end of the reaction are water and manganese dioxide. All\ncomponents in this system are designed for single use only.\n173.22\n030303\n\n<<<PAGE 2>>>\n\nBased on the information you provided, it is this Office's opinion that a water solution of\napproximately 7.5 % hydrogen peroxide by weight does not meet the definition in § 173.127 as a\nDivision 5.1 (Oxidizer). The manganese oxide (principal reactant) may be an oxidizer if data or\nexperience indicates that it meets the definition in § 173.127 as a Division 5.1 (Oxidizer). As\ndefined in § 171.8 of the HMR, an oxygen generator (chemical means a device containing\nchemicals that upon activation releases oxygen as a product of chemical reaction. A device that\nmeets the definition in § 171.8 for an \"Oxygen generator (chemical),\" must be described on a\nshipping paper as \"Oxygen generator, chemical, 5.1, UN 3356, PG II,\" and all other applicable\nrules of the HMR would apply.\nwith its means of initiation attached must incorporate at least two positive means of preventing\nIn § 172.102, Special Provision 60 specifies that a chemical oxygen generator that is shipped\nunintentional actuation of the generator, and be classed and approved by the Associate\nAdministrator for Hazardous Materials Safety. Procedures for filing for an approval request are\nfound in Subpart H of Part 107 of the HMR.\nEach person who offers a chemical oxygen generator for transportation must: (1) ensure that it is\noffered in conformance with the conditions of the approval; (2) maintain a copy of the approval\nat each tacility where the chemical oxygen generator is packaged; and (3) mark the approval\nnumber on the outside of the package. For example, since the product is designed to be flexibly\noperable with very light pressure breaking the membrane between the activating catalyst and the\nreactant hydrogen peroxide solution, preventing unintentional activation may necessitate that the\nsoft flexible pouch be enclosed in a rigid container for transportation.\nTransportation of a chemical oxygen generator is forbidden on passenger-carrying aircraft. A\nspent, chemical oxygen generator is forbidden on passénger-carrying and cargo-only aircraft.\nSpecial Provision A51 specifies that when transported by cargo-only aircraft, an oxygen\ngenerator must conform to the provisions of Special Provision 60 and be contained in a\npackaging prepared and originally offered for transportation by the approval holder.\nI hope this satisfies your inquiry. If we can be of further assistance, please contact us.\nOffice of Hazardous Materials Standards\n\n<<<PAGE 3>>>\n\nEngrum\nNENE LABS\n$173.22\nan! Pharmar cubical\nse Pedoperor of the Family\nShippers Responsibility\n03-0303\nNovember 12, 2003\nEdward Mazzullo\n400 7* Street South West\nUSDOT/RSPA, DHIM-10\nWashington, DC 20590-0001\nMr. Mazzullo,\nOur sales representative (Jeff Morris) talked with you two weeks ago in\nregards to getting a hazardous materials qualification from you on a\nproduct we are developing for OX-GEN.\nlere is a draft of our 510 (k) for the FDA. Hopefully it is detailed enough\nor vou to deterpine if our product will be considered lazardous Material.\n*ni Featulations\nPlease let me know what we need to do next to get the classification.\nThank you for your time,\nSoak and Heati\nBath Tablets wize Aloe\nSiff Jerome\n-Jeff Jerome\nJeff Jerome\njlerome@nenelabs.com\nAlex Thompson\nAThompson@nenelabs.com\n(866) 588-7644\n\"..:\nFax: (877) 553-7663 » 5115 Gage 5: 5 :","truncated":false,"body_characters":5604}