{"operation":"document","citation":"18-0159","title":"Dorsey and Whitney LLP — Hazardous Materials Safety Interpretation","source_type":"guidance","agency":"Pipeline and Hazardous Materials Safety Administration","status":"guidance","official":true,"published_on":"2019-05-02","effective_on":null,"summary":"18-0159 response to Dorsey and Whitney LLP concerning 173.185.","machine_formats":{"json":"https://regulus.evalyn.ai/document/phmsa-interpretation-18-0159.json","markdown":"https://regulus.evalyn.ai/document/phmsa-interpretation-18-0159.md"},"app_url":"https://regulus.evalyn.ai/document/phmsa-interpretation-18-0159","source_url":"https://www.phmsa.dot.gov/sites/phmsa.dot.gov/files/docs/standards-rulemaking/hazmat/interpretations/71366/180159.pdf","body":"<<<PAGE 1>>>\n\n0\nU.S. Department\nof Transportation\nPipeline and Hazardous\nMaterials Safety\nAdministration\n1200 New Jersey Avenue, SE\nWashington, DC 20590\nMAY O 2 2019\nMark R. Kaster\nPartner\nDorsey and Whitney LLP\n50 South Sixth Street\nSuite 1500\nMinneapolis, MN 55402-1498\nReference No. 18-0159\nDear Mr. Kaster:\nThis letter is in response to your December 13, 2018, email requesting clarification of the\nHazardous Materials Regulations (HMR; 49 CFR Parts 171-180) applicable to hazard\ncommunication requirements for packages containing lithium button cell batteries installed in\nequipment. You describe a blood glucose monitoring device that contains lithium metal button\ncell batteries of a type that meets the criteria in the United Nations (UN) Manual of Tests and\nCriteria Part III, Sub Section 38.3. You state that each device is placed in its own boxed\npackaging for retail distribution and sale, which is then placed in an overpack. Each overpack\ncontains 12-24 retail units. Specifically, you ask whether packages containing lithium button\ncell batteries installed in equipment must display the lithium battery mark in accordance with\n§ 173.185( C )(3).\nThe answer is no. Packages containing only lithium button cell batteries installed in equipment,\nincluding the button cells in your blood glucose monitoring devices, that comply with the\nrequirements of§ 173.185(c) are not required to display the lithium battery mark. This applies\nregardless of the number of packages per consignment, the number of pieces of equipment per\npackage, or the number of lithium button cell batteries installed in each piece of equipment.\nI hope this information is helpful. Please contact us if we can be of further assistance.\nSincerely,\n~~~Y'~\nT. Glenn Foster\nChief, Regulatory Review and Reinvention\nStandards and Rulemaking Division\n\n<<<PAGE 2>>>\n\nJanuary, Ikeya CTR (PHMSA)\nFrom: INFOCNTR (PHMSA)\nSent:\nTo:·\nSubject:\nFriday, December 14, 2018 2:14 PM\nHazmat Interps\nFW: Request for Interpretation\nHello Alice and lkeya,\nI talked with Mark about his interpr~tation request and mentioned that a couple of other letters on the same situation\nare in the works. He would still like to submit his request for a formal letter of interpretation. Thanks!\nSincerely,\nLynsie Patschke\nTransportation Regulatory Specialist\nHazardous Materials Information Center (HMIC)\nFrom: Kaster.Mark@dorsey.com [mailto:Kaster.Mark@dorsey.com]\nSent: Thursday, December 13, 2018 3:32 PM\nTo: INFOCNTR (PHMSA) <INFOCNTR.INFOCNTR@dot.gov>\nSubject: RE: Request for Interpretation\nVia E-mail - infocntr@dot.gov\nShane Kelley, Director\nStandards and Rulemaking Division\nU.S. DOT/PHMSA (Plll-1-10)\n1200 New Jersey A venue, SE East Building, 2nd Floor\nWashington, DC 20590\nRe: Request for Letter Interpretation of Hazardous Materials Regulations (HMR) for Lithium Cells and Batteries, 49\nC.F.R. § 173.185(c)(3)\nDear Mr. Kelley:\nI am counsel for ARKRA Y USA, Inc. I am submitting this to request a formal interpretation of the lithium battery\nregulations (\"HMR Regulations\") found in 49 C.F.R. § 173.185( c X3).\nMy client manufacturers Blood Glucose Monitoring Meters** (herein \"Meter(s)\") that include a small lithium metal button\nbattery with a lithium content of .07 grams installed in the device. The lithium metal button batteries are manufactured\naccording to the requirements of UN Manual of Tests and Criteria. Each Meter is placed in its own boxed packaging for\nretail distribution and sale. There is no spare battery provided within the packaging. The Meters are transported to retailers,\nmostly through ground, but occasionally through air modes of transportation. The shipments may include overpacks\ncontaining multiple units (usually in counts of 12-24 retail units in an overpack) of individual packaged products.\n**The specific products involved are noted below and can be viewed at:\nhttps://www.walmart.com/search/?cat id=976760 2289975 9391152 6927535&grid=true&guery=relion+prime&typeahead\n=relio#searchProductResult\n1\n\n<<<PAGE 3>>>\n\n• Arkray Item# 701103 ReliOn Prime Meter Kit Red\nWMIT# 556621084\n• Arkray Item# 782001 ReliOn Premier BLU Basic Meter\nWMIT# 565694297\n• Arkray Item# 783110 ReliOn Premier Compact Meter Kit\nWMIT# 570597542\nQuestions for which Clarification is Requested\nDoes transport of a product containing a small lithium metal button battery installed in a medical device fall under the\nmarking exception in 49 C.F.R. Part 173.185(c)(3)? _\nIn other words, does the provision in 173,185(c)(3) which states that \"a\npackage display the lithium battery mark except when a package contains button cell batteries installed in equipment\n(including circuit boards), or no more than four lithium cells or two lithium batteries contained in equipment, where there are\nnot more than two packages in the consignment\" mean that that button battery installed in equipment are exempt and not\nqualified by the last phrase referencing two or more packages in a consignment.\nDiscussion\nI previously contacted the agency in 2015 and requested an interpretation regarding marking requirements for lithium button\nbatteries installed in a product under 173.185(c). The agency's response (Reference No. 15-0114) confirmed that button\nbatteries as described were exempt from the marking requirements, including when individual packages were aggregated and\nshipped in an overpack or on a pallet. Since the language of 173 .185( c) has slightly changed from the prior 2015 version\nof the regulation, I contacted the PHMSA hotline and also spoke with Kevin Leary of your staff to confrrm that the marking\nexemption for button batteries was still applicable to the ARKRA Y products. I was informed that the marking exemption\nwas still in place, and that the products as described were still exempt from any marking requirements. My client has a retail\ncustomer (Walmart) who has asked that we obtain a formal letter to confirm the information provided orally by PHMSA\nstaff.\nConclusion\nMy client wants to confirm that no marking is required for the transport of packages, overpacks and/or pallets by surface or\nair transportation where the packaging contains products with small lithium metal button batteries installed in the products.\nPlease contact me should you have any questions.\nThank you for your assistance.\nMark\nMark R. Kaster\nPartner\n( ~) DORSEY.\n;;;!·110ys ahead\nDORSEY & WHITNEY LLP\nSuite 1500, 50 South Sixth Street I Minneapolis, MN 55402-1498\nPhone: 612.340.7815 Fax: 952.516.5607\nWWW.DORSEY.COM :: MINNEAPOLIS :: BIO :: V-CARD\nCONFIDENTIAL COMMUNICATION\nE-mails from this firm normally contain confidential and privileged material, and are for the sole use of the intended recipient.\nUse or distribution by an unintended recipient is prohibited, and may be a violation of law. If you believe that you received\nthis e-mail in error, please do not read this e-mail or any attached items. Please delete the e-mail and all attachments,\nincluding any copies thereof, and inform the sender that you have deleted the e-mail, all attachments and any copies thereof\nThank you.\nPlease help reduce paper and ink usage. Print only if necessary.\n2","truncated":false,"body_characters":7119}