{"operation":"document","citation":"08-0290","title":"Sensitech, Inc. — Hazardous Materials Safety Interpretation","source_type":"guidance","agency":"Pipeline and Hazardous Materials Safety Administration","status":"guidance","official":true,"published_on":"2008-12-17","effective_on":null,"summary":"08-0290 response to Sensitech, Inc. concerning 172.102.","machine_formats":{"json":"https://regulus.evalyn.ai/document/phmsa-interpretation-08-0290.json","markdown":"https://regulus.evalyn.ai/document/phmsa-interpretation-08-0290.md"},"app_url":"https://regulus.evalyn.ai/document/phmsa-interpretation-08-0290","source_url":"https://www.phmsa.dot.gov/sites/phmsa.dot.gov/files/legacy/interpretations/Interpretation%20Files/2008/080290.pdf","body":"<<<PAGE 1>>>\n\nU.S. Department\nof Transportation\nPipeline and Hazardous\nMaterials Safety\nAdministration\n1200 New Jersey Ave., S E.\nWashington. DC 20590\nDEC 1 7 2008\nMr. Henry Ames\nDirector of Strategic Marketing\nSensitech, Inc.\n800 Cummings Center, Suite 258x\nBeverly, MA 0 1 9 1 5\nRef. No.: 08-0290\nDear Mr. Ames:\nThis is in response to your inquiry, submitted by einail, dated December 1, 2008, and\nsubsequent emails and phone conversations, concerning the compliance of certain temperature\nand humidity monitoring devices marketed by Sensitech with requirements of the Hazardous\nMaterial Regulations (HMR; 49 CFR Pai-ts 17 1-1 80), particularly with regard to the\nprovisions of Special Provision (SP) 188 of S 172.102(c)(l).\nYou described these monitoring devices as incorporating small, primary lithium batteries and\nprovided information on each type of battery, with regard to lithium content, and compliance\nwith applicable regulatory standards such as SP 188 and the LJ Manual of Tests and Criteria,\nand on the test regimen (electromagiietic compatibility testing. vibration testing, shock\ntesting, and water resistance and submersion testing) to which each type of device has been\nsubjected. Using your non~enclature, the products are described as VaxAlert, FreezeAlei-t,\nTempTale 4 (TT4), TT4 USB, TT4 RF, TagAlert, TTMini, and TT4 Dry Ice. You indicated\nthe devices are used to monitor temperature- and humidity-sensitive products, many of which\nare pl~armaceuticals, and nlay be attached to pallets or packages, placed inside a package, or\nbuilt into a packaging containing these products.\nYou indicated there is some confi~sion as to whether these cargo monitoring devices are\nsubject to the HMR. The devices are offered for transport and transported in commerce; thus,\nto the extent they contain hazardous materials, they are subject to applicable provisioils of the\nHMR.\nBased on the information you have provided, we agree with your assessment that these\ndevices qualify for the exceptions provided for small lithium batteries under SP 188.\nSpecifically, the batteries confonll to the provisions in paragraph a(2) as they are contained in\nequipment and meet the quantity and net weight limits specified. Therefore, the devices are\nnot prohibited for transport aboard passenger aircraft nor are they subject to the marking\nrequirement of paragraph a(1). Moreover, the batteries coilform to the lithium content\nlimitations of paragraphs b and c, and it appeays that all battery types n~eet, or will meet by\n\n<<<PAGE 2>>>\n\nOctober 1,2009, the test requirements of paragraph d. The batteries are separated so as to\nprevent short circuits and contained in equipment ii-1 conformance with the requirements of\nparagraph e. Finally, based on the information you provided conceming the test regimen to\nwhich the devices are subject, the devices conform to the requirements of 173.21 of the\nHMR, in that they do not appear likely to create sparks or generate a dangerous quantity of\nheat and, thus, meet the requirements of paragraph g. Paragraphs f and h do not apply to your\nsituation.\nWith regard to your request that certain information contained in your submissioils not be\nmade available for public release, please see 49 CFR 105.30 for the procedure for requesting\nconfidential treatment. Also, note that the HMR do not address electron~agnetic compatibility\nrequirements, which fall under the Federal Aviation Regulations. If you have questions\nconceming those requirements, they should be addressed to the Federal Aviation\nAdministration.\nI trust this satisfies your inquiry. If we can be of further assistaice, please contact us.\nSincerely,\nf\"z'yd Edward T. Mazzullo\nDirector, Office of Hazardous Materials Standards\nPipeline and Hazardous Materials Safety Administration\n\n<<<PAGE 3>>>\n\nURGENT - IMMEDIATE RESPONSE REQUESTED\nTOPIC: REQUEST FOR INTERPRETATION OF -\n\"FEDERAL REGISTER PART 111, DEPARTMENT OF TRANPORTION (DOT)\nPIPELINE AND HAZARDOUS MATERIELS SAFETY ADMINISTRATION\n(PHMSA)- 49 CFR PARTS 171,172,173, and 175 HAZARDOUS MATERIALS;\nTRANSPORTATION of LITHIUM BATTERIES; FINAL RULE\nThursday, August 9,2007\"\nDate: Monday, December 0 1,2008\nFROM:\nHenry Arnes, Director of Strategic Marketing\nSensitech Inc\n800 Cummings Center\nSuite 258x\nBeverly, MA 01982\nTO:\nATTN: Kevin Leary\nCC: Ed Mazzullo\nCC: Shane Kelley\nU.S. Department of Transportation\n1200 New Jersey Ave, SE\nWashington, DC 20590\nDear Department of Transportation (DOT),\nSensitech respectfully requests that the DOT issue an \"Official Interpretation\" to\ninclude devices like temperature monitors to be covered bv DOT (PHMSA) 49 CFR\nParts 171,172,173, and 175 for all modes of transportation - specificallv air\ntransport.\nDelta Airlines has brought to Sensitech's attention a grey area of interpretation in the\ncurrent CFR. Specifically, Delta and potentially other airlines do not interpret the current\nCFR to include devices powered by lithium batteries that are used to support or monitor\ncargo. The current CFR as written primarily covers batteries as cargo both bulk and\nwithin equipment itself or batteries in carry-on or checked passenger luggage.\nWere the CFR interpreted to include these tvpes of devices, all of Sensitech's\ntemperature monitoring devices would fall under Part 172.102 Special Provisions\nSection 188 Small Lithium Cells and Batteries. Please see attached supporting\ndocumentation.\n\n<<<PAGE 4>>>\n\nThis \"grey area\" in the current CFR creates a serious potential threat to our healthcare\nsystem and overall patient safety. NOTE: During The International Air Transport\nAssociation's (IATA) Time and Temperature Task Force (TTTF) subgroup bi-weekly\ncall this morning it was noted that British Airways and American Airlines have both\nexpressed concern for this \"grey area\" and may adopt Delta's position - adding to the\nurgency of this matter.\nAs you will see in the attached documentation, Delta Airlines notified all of their shippers\non August 25, that they will no longer accept \"shipments containing devices powered by\nlithium batteries, regardless of the amount of lithium contained\". The position taken by\nDelta was described by Jim Shimko, Project Manager in the Corporate Dangerous Goods\nGroup in the following manner: \"There is nothing in the regulations that says you can\nship these types of monitoring devices along with cargo but there is nothing in\nregulations that says you cannot either\". Hence, Delta has chosen a conservative\ninterpretation of the regulations despite the fact that our devices are compliant with the\nlimits outlined by Part 172.102 Section 188.\n172.102 Special Provision\n29.\n(a,) \"For a lithium metal cell or battery, the lithium content is not more than 1 .Og per cell\nand the aggregate lithium content is not more than 2.0g per battery.. .\" Sensitech utilizes\nseveral different types of batteries. The most commonly used is the CR 2032\nmanufactured by Sony and Panasonic which has a lithium mass of 0.062g. NOTE: All\nbatteries used by Sensitech comply with this specification. Please see the attached\nsupporting documentation.\n(b.) NOTE: The cells or batteries used by Sensitech are encased in a device. This\nsection is currently written to address bulk shipments of batteries.\n(c.) NOTE: This section seems to address bulk shipments of batteries not batteries\ncontained in devices. That being said, as is similar in the points above each cell or\nbattery is individually encased in a device.\n188 Small Lithium Cells and Batteries \"Lithium cells or batteries, including cells or\nbatteries packed with or contained in equipment, are not subject to any other\nrequirements of this subchapter if they meet all of the following:\" NOTE: Sensitech\nfeels the words \"contained in equipment\" should apply to devices like temperature\nmonitors, regardless of operation status (powered on or off).\n(2) \"The provisions of paragraph (a)(l) do not apply to packages that contain 5 kg. net\nweight or less of primary lithium batteries or cells that are contained in or packed with\nequipment and the package contains no more than the number of lithium batteries or cells\nnecessary to power the piece of equipment.\" NOTE: We believe that all of Sensitech's\nproducts comply with this provision because the batteries are \"contained in. ..\nequipment\" and the net weight is less than 5 kg.\n\n<<<PAGE 5>>>\n\n(b.) \"For a lithium metal or lithium alloy cell, the lithium content is not more than 1.0 g.\nNOTE: All of Sensitech's products comply with this provision. Please see attached\nsupporting documentation.\n(c.) \"For a lithium metal or lithium alloy battery, the aggregate lithium content is not\nmore than 2.0 g. For a lithium-ion battery, the aggregate equivalent lithium content is not\nmore than 8 g.\" NOTE: All of Sensitech's products comply with this provision.\nPlease see the attached supporting documentation.\n(d.) \"Effective, October 1,2009, the cell or battery must be of a type proven to meet the\nrequirements of each test in the UN Manual of Tests and Criteria (IBR; see 171.7 of this\nsubchapter).\" NOTE: We are working to obtain the relevant supporting\ndocumentation from our battery suppliers. We fully expect compliance within the\nstated deadline.\n(e.) \"Cells or batteries are separated so as to prevent short circuits and are packed in a\nstrong outer packaging or contained in equipment;\" NOTE: Batteries used in\nSensitech's devices are \"contained in equipment\". All temperature monitoring\ndevices are tested and receive a certificate of validation linked to the unique serial\nnumber of the device. Should you feel it appropriate, validation package is\navailable for your review.\n(f.) \"Effective October 1,2008, except when contained in equipment, each package\ncontaining more than 24 lithium cells or 12 lithium batteries must be:\" NOTE: Because\nall batteries are \"contained in equipment\" this provision does not apply to\ntemperature monitors.\n(g.) \"Electrical devices must conform to 173.21 of this subchapter; and\" NOTE: We\nhave reviewed 173.21 and feel that all of Sensitech's products comply with this\nprovision.\nI greatly appreciate your prompt review and response to this request. As stated above,\neliminating the existing ambiguity within the current 49 CFR Parts 171, 172, 173 and 175\nto include devices powered by lithium batteries that are used to monitor shipments is\ncritically important to protect protecting product quality and patient safety.\nPlease contact me at your earliest convenience to let me know how the DOT will\nrespond.\nSin &J- ely,\nHenry Ames\nDirector, Strategic Marketing\nPhone: 978-720-2541\nEmail: hames@,s!sensitech.com","truncated":false,"body_characters":10574}