{"operation":"document","citation":"15-0114","title":"Dorsey & Whitney LLP — Hazardous Materials Safety Interpretation","source_type":"guidance","agency":"Pipeline and Hazardous Materials Safety Administration","status":"guidance","official":true,"published_on":"2015-08-21","effective_on":null,"summary":"15-0114 response to Dorsey & Whitney LLP concerning 173.185.","machine_formats":{"json":"https://regulus.evalyn.ai/document/phmsa-interpretation-15-0114.json","markdown":"https://regulus.evalyn.ai/document/phmsa-interpretation-15-0114.md"},"app_url":"https://regulus.evalyn.ai/document/phmsa-interpretation-15-0114","source_url":"https://www.phmsa.dot.gov/sites/phmsa.dot.gov/files/legacy/interpretations/Interpretation%20Files/2015/150114.pdf","body":"<<<PAGE 1>>>\n\nof Transportation\nU.S. Department\nWashington, DC\n1200 New Jersey Avenue SE\n20590\nPipeline and Hazardous\nAdministration\nMaterials Safety\nAUG 2 1 2015\nMr. Mark R. Kaster\nDorsey & Whitney LLP\n50 South Sixth Street, Suite 1500\nMinneapolis, MN 55402-1498\nReference No.: 15-0114\nDear Mr. Kaster:\nThis is in response to your June 5, 2015 letter in which you requested written clarification of\nthe Hazardous Materials Regulations (HMR; 49 CFR parts 171-180) concerning the\nexceptions for small lithium cells or batteries installed in a device.\nIn your letter, you provide information about a device, an installed lithium button cell\nbattery and its packaging. The device contains one lithium metal button cell battery with a\nlithium content of 0.07 grams. The lithium button cell battery is of a type that meets the\ncriteria in the UN Manual of Tests and Criteria Part III Sub Section 38.3. One device is\npackaged in a retail packaging, and there are no spare batteries in the packaging. Several\nretail packages are consolidated in an overpack and transported by ground or air.\nAlternatively, multiple overpacks are palletized and shrink-wrapped and transported by\nground or air. Your questions are paraphrased and answered below.\nQ1. Please confirm that a lithium button cell battery installed in the device as described\nabove meets the exceptions contained in § 173.185(c) and no special marking is required on\nthe package even when the individual packages are aggregated and shipped in an overpack\nor on a pallet.\nAl. Your understanding is correct. In accordance with § 173.185(c), a package containing\nlithium metal cells or batteries (not exceeding 1 g for a lithium metal cell or 2 g for a lithium\nmetal battery contained in equipment in quantities less than 5 kg net weight per package is\nexcepted from the requirement to mark the outer package to indicate it is forbidden aboard\npassenger aircraft. In addition, § 173.185 (c)(3) excepts button cell batteries installed in\nequipment from the hazard communication requirements, including marking and\ndocumentation requirements prescribed in § 173.185 (c)(3)(i) and (ii), respectively.\nProvided the retail packaging that contains the lithium metal button cell battery installed in\nthe device meets the general packaging requirements for lithium batteries contained in\nequipment prescribed in § 173.185(b)(4), the package is not subject to marking or hazard\ncommunication requirements. This exception applies regardless of whether or not multiple\npackages are consolidated and shipped in an overpack.\n\n<<<PAGE 2>>>\n\n2\nQ2. Section 173.185(c)(4) prescribes additional requirements for smaller cells or batteries\ntransported by air. You ask if a package containing lithium metal button cell batteries\ninstalled in equipment that otherwise meets the provisions for smaller cells and batteries in\n§ 173.185(c)(3) is required to be marked with the lithium battery handling mark in\n§ 173.185 (c)(4)(i).\nA2. The exception provided in § 173.185(c)(3) that excepts packages containing button cell\nbatteries installed in equipment (including circuit boards), or no more than four lithium cells\nor two lithium batteries installed in the equipment, from the hazard communication\nrequirements also applies to air transport. We intend to clarify in a future rulemaking that\nthe handling mark in $ 173.185(c)(4)(i) is not required on packages containing button cell\nbatteries installed in equipment (including circuit boards) or no more than four lithium cells\nor two lithium batteries installed in equipment.\nI trust this information is helpful. Please do not hesitate to contact us if you have any\nquestions.\nSincerely,\nhan r-belly for\nMr. Duane Pfund\nInternational Standards Coordinator\nOffice of Standards and Rulemaking\n\n<<<PAGE 3>>>\n\nDORSEY™\nAntonielli\nDORSEY & WHITNE\n$173.185\nBatteries\nJune 5, 2015\n15-0114\nCharles E. Betts, Director\nBY CERTIFIED MAIL\nStandards and Rulemaking Division\nRETURN RECEIPT REQUESTED\nU.S. DOT/PHMSA (PHH-10)\n1200 New Jersey Avenue\nSE East Building, 2nd Floor\nWashington, DC 20590\nRe: Request for Letter of Interpretation of Hazardous Materials Regulations (HMR)\nfor Lithium Cells and Batteries, 49 C.F.R. § 173.185\nDear Mr. Betts:\nWe are submitting this letter to request a formal interpretation of the lithium battery\nregulations (\"HMR Regulations\") found in 49 C.F.R. § 173.185. We are seeking clarification on\nwhether the lithium metal button battery contained in a hand-held medical device and distributed\nthrough various modes of transportation (1) is exempt from the majority of requirements of the\nHMR Regulations under the exceptions for smaller cells or batteries, and (2) does not require a\nlithium battery label or a handling label on the exterior of (i) overpacks containing multiple units\nof individual retail packages of the product when shipped via ground or air modes of\ntransportation, and (ii) palletized configurations containing multiple overpacks, when shipped via\nground or air modes of transportation.\nWe are making this request because we understand that the HMR Regulations were\nintended to be harmonized with international standards (e.g., International Air Transport\nAssociation (IATA) guidelines), but we need clarification on a discrepancy between the HMR\nRegulations and the IATA guidelines.\nA.\nFactual Background\nOur client sells a consumer handheld medical device that contains one small lithium\nmetal button battery with a lithium content of .07 grams. The lithium metal button batteries are\nmanufactured according to the requirements of UN Manual of Tests and Criteria. The button\nbattery is packed in the medical device and the medical device is then placed into retail\npackaging. There are no spare batteries provided within the packaging. The products are\ntransported for distribution in their retail packages. However for shipping logistics purposes,\nmultiple retail packages may be placed in an overpack in various configurations (usually in\ncounts of 12-24 retail units in an overpack) and many overpacks may be placed on a shrink-\nwrapped gaylord or pallet for shipment. The devices can be transported either by air or surface\nmodes of transportation in the United States.\nSUITE 1500 • 50 SOUTH SIXTH STREET • MINNEAPOLIS, MINNESOTA 55402-1498\nDORSEY & WHITNEY LLP • WWW.DORSEY.COM • T 612.340.2600 • F 612.340.2868\nUSA CANADA EUROPE ASIA-PACIFIC\n\n<<<PAGE 4>>>\n\nDORSEY™\nMr. Charles E. Betts\nPage 2\nJune 5, 2015\nB.\nQuestions for which Clarification is Requested\n1. Does the shipment of a product containing a lithium metal button battery with .07\n173.185(c), where multiple individual packages of the product may be\ngrams of lithium content fall under the small battery exclusion in 49 C.F.R. Part\nunder the small battery exclusion when multiple units of the product are\noverpacked or palletized and transported together?\n2. Does the exterior of the overpack or palletized shipment of products require a\nlithium battery label or a handling mark under the HMR Regulations where the\nproducts included in the overpack or pallet are separately packaged and each\nproduct package only contains a single .07 gram lithium button battery installed\nin the product?\nC. Analysis\nThe lithium metal button batteries contained in the medical devices fall within the\nexception for smaller cells or batteries under 49 C.F.R. 173.185(c) because the lithium content\n(only .07 gram) does not exceed the 2 gram threshold established for lithium metal batteries in\nthe HMR Regulations. Further, the HMR Regulations state that except where the lithium metal\nforbid transport aboard passenger aircraft. Further, the HMR Regulations state that except for a\nbatteries are packed with or contained in equipment, the outer package must be marked to\npackage containing button cell batteries installed in equipment, certain hazard communication\nrequirements are triggered, including the marking of the outer package. 49 C.F.R. 173.185(c)\n(1) and (3).\nOur interpretation is that small lithium button cell batteries (07 grams) installed in the\nmedical devices meets the exceptions for smaller cells or batteries in the HMR Regulations and\ndo not require any special markings on the package, even when the individual packages are\naggregated and shipped together in an overpack or on a pallet. We ask the agency to confirm\nFor transportation by air, the exception for smaller lithium cells or batteries are\nsubject to the provisions of 49 C.F.R. 173.185(c) (4). The HMR regulations provide that for\nlithium metal batteries with a content of not more than 0.3 grams, there is no limit on the\nmaximum number of batteries in a package. Id. However, that HMR Regulations state that the\nouter package must be durably and legibly marked with a \"handling mark\" displayed on a\nbackground of contrasting color. 49 C.F.R. 173.185(c) (4)(i).\nDORSEY & WHITNEY LLP\n\n<<<PAGE 5>>>\n\nDORSEY™\nMr. Charles E. Betts\nJune 5, 2015\nPage 3\nThe IATA requirements provide that \"a lithium battery handling label is not required for\npackages. where a package contains not more than 4 cells or batteries installed in equipment\nprepared in accordance with Section Il of Packing Instructions 967 and 970.\" See IATA, Lithium\nBattery Guidance Document (\"IATA Guidance Document\") at 19,\nhttp://www.iata.org/whatwedo/cargo/dgr/Documents/lithium-battery-guidance-document-2015-\nthat lithium metal button cell batteries installed in equipment \"present virtually no risk in\nen.paf. Moreover, we note that the International Civil Aviation Organization (ICAO) has stated\ntransportation.\" See, ICAO, Lithium Ion and Lithium Metal Button Cells Installed in Equipment,\nhttp://www.icao.int/safety/DangerousGoods/Working%20Group%20of%20the%20Whole%2012/\nDGPWG.12.WP.051.2.en.pdf.\nSince the HMR Regulations and the IATA requirements were to be harmonized, we\nwould like the agency to confirm whether a lithium battery handling mark is required for the air\nshipment of products containing only small lithium button batteries that meet the exceptions in\nthe HMR Regulations for smaller cells or batteries.\nD.\nConclusion\nWe want to confirm that no special labeling or handling marking is required for the\ntransport of packages, overpacks and/or pallets by air or surface transportation where the\npackaging contains products with small lithium metal button batteries installed in the products\nand the lithium batteries meet the exceptions for smaller cells or batteries in the HMR\nRegulations.\nThank you for your consideration. Please contact me should you have any questions.\nVery truly yours,\nMark R. Kaster\nMRK\nDORSEY & WHITNEY LLP","truncated":false,"body_characters":10569}