{"operation":"document","citation":"24-0070","title":"ProteQ — Hazardous Materials Safety Interpretation","source_type":"guidance","agency":"Pipeline and Hazardous Materials Safety Administration","status":"guidance","official":true,"published_on":"2024-10-02","effective_on":null,"summary":"24-0070 response to ProteQ concerning 173.185.","machine_formats":{"json":"https://regulus.evalyn.ai/document/phmsa-interpretation-24-0070.json","markdown":"https://regulus.evalyn.ai/document/phmsa-interpretation-24-0070.md"},"app_url":"https://regulus.evalyn.ai/document/phmsa-interpretation-24-0070","source_url":"https://www.phmsa.dot.gov/sites/phmsa.dot.gov/files/2025-03/240070.pdf","body":"<<<PAGE 1>>>\n\nU.S. Department\nof Transportation\nPipeline and Hazardous\nMaterials Safety\nAdministration\n1200 New Jersey Avenue, SE\nWashington, DC 20590\nOctober 2, 2024\nBen Smith\nSr. Multimodal DG Specialist\nProteQ\n2325 Dulles Corner Blvd\nSte 725\nHerndon, VA 20171\nReference No. 24-0070\nDear Mr. Smith:\nThis letter is in response to your July 24, 2024, email requesting clarification of the Hazardous\nMaterials Regulations (HMR; 49 CFR Parts 171-180) applicable to the requirements for\nprototype lithium cells or batteries found in 49 CFR 173.185(e).\nWe have paraphrased and answered your questions as follows:\nQ1. You ask whether the meaning for “low production” and “prototype” lithium cells or\nbatteries in § 173.185(e) are intended to be the same.\nA1. The answer is no. While the exceptions in § 173.185(e) can apply to both low production\nruns of lithium cells or batteries and to prototype lithium cells or batteries transported for\npurposes of testing, these two terms are separate.\nQ2. You ask whether there is a maximum quantity of prototype lithium cells or batteries\ntransported for purposes of testing that are permitted to be offered by air annually.\nA2. The answer is no. However, to qualify for the exceptions in § 173.185(e) the prototype\nlithium cells or batteries must be transported for purposes of testing.\nQ3. You ask whether § 173.185(e) limits low production lithium cells or batteries to 100 (or\nless) offered in commerce for air transportation per year.\nA3. Section 173.185(e) defines a low production run of batteries as “annual production runs\nconsisting of not more than 100 lithium cells or batteries.” This is a production limit, not\na limit on annual shipments by air or other mode. If more than 100 of a lithium cell or\nbattery type are produced in an annual production run, those lithium cells or batteries are\nnot considered a low production run.\n\n<<<PAGE 2>>>\n\nQ4. You ask whether there is a limit on the number of prototype lithium cells or batteries\ntransported for purposes of testing that a shipper can offer into commerce annually.\nA4. The answer is no. If the prototype lithium cells or batteries are being transported for\npurposes of testing, there is no annual limit on the number of prototype lithium cells or\nbatteries a shipper can offer into commerce annually. However, any prototype lithium\ncells or batteries being transported for purposes other than testing would not qualify for\nthe exceptions in § 173.185(e). Please note that PHMSA cannot determine whether the\nlithium cells or batteries in your specific scenarios are prototypes being transported for\npurposes of testing based on the information provided.\nQ5. If the answer to question Q4 is yes, you ask whether a manufacturer is limited by each\ndesign type they produce or by all UN 38.3 untested prototypes lithium cells or batteries\nacross all design types they produce.\nA5. See answer A4. There is no annual shipment limit for prototype lithium cells or batteries\nas long as they are being transported for the purposes of testing. Please note that PHMSA\ncannot determine whether the lithium cells or batteries in your specific scenarios are\nprototypes being transported for purposes of testing based on the information provided.\nI hope this information is helpful. Please contact us if we can be of further assistance.\nSincerely,\nAlexander Wolcott\nActing Chief, Regulatory Review and Reinvention Branch\nStandards and Rulemaking Division\n\n<<<PAGE 3>>>\n\nJacobson\n24-0070\nFrom: INFOCNTR (PHMSA)\nTo: Dodd, Alice (PHMSA)\nCc: Hazmat Interps\nSubject: FW: Request for Written Letter of Intrepretation\nDate: Tuesday, August 6, 2024 2:22:25 PM\nAttachments: Request for Written Letter of Intrepretation.msg\nHello Alice,\nSee the attached interpretation request. Let us know if you need anything else.\nBest,\nAminah\n-----Original Message-----\nFrom: Ben Smith <bsmith@proteq.com>\nSent: Wednesday, July 24, 2024 10:18 AM\nTo: INFOCNTR (PHMSA) <INFOCNTR.INFOCNTR@dot.gov>\nSubject: Request for Written Letter of Intrepretation\nCAUTION: This email originated from outside of the Department of Transportation (DOT). Do not click on links or\nopen attachments unless you recognize the sender and know the content is safe.\n\n<<<PAGE 4>>>\n\nFrom: Ben Smith\nTo: INFOCNTR (PHMSA)\nSubject: Request for Written Letter of Intrepretation\nDate: Wednesday, July 24, 2024 10:18:09 AM\nAttachments: image001.jpg\nTo Whom it may Concern :\nOur client (the grantee of a PHMSA CAA), manufactures lithium metal batteries in the U.S.,\nthat are then shipped to their EU facility, and installed in implantable medical devices for\nfurther evaluation and developmental testing including FDA approval testing. Our client offers\nthese prototype batteries into commerce for air transport as UN 3090 under the regulatory\nauthority of ICAO SP A88 and 49 CFR§ 173.185(e) for shipping prototype batteries.\n49 CFR § 173.185(e) use the terms “low production runs,” and “prototype” in describing the\napplicability of the standard. The regulatory language of § 173.185 (e) seems to limit “low\nproduction runs” to no more than 100 cells or batteries per year, and then separates by a\ncomma (in the language of the regulations) “prototype” lithium cells or batteries. Our\nquestions are:\n1. Is PHMSA’s definition of “low production,” and “prototype” batteries intended to\nbe one in the same?\n2. If the “low production,” and “prototype” are meant to be different, what is the\nmaximum quantity of “prototype” batteries that are permitted to be offered into\ncommerce via the air mode annually?\n3. Both SP A88, § 173.185(e) and the CAA appear to suggest that a shipper\n(manufacturer) of low production batteries is limited to permitting 100 or less\nbatteries offered into commerce for air transport per year. Is this correct?\n4. If there is a limit of the number of protype batteries offered into commerce\nannually, and our client manufacturer’s several UN38.3 untested design type\nbatteries (different models and sizes of prototype UN3090), does the limitation of\nthe number of batteries per year apply to each design type of UN38.3 untested\nprototype batteries (again different models), or does the annual limitation apply to\nall UN38.3 untested prototype batteries manufactured at our clients facility?\nThank you and we look forward to your reply.\nV/R,\n\n<<<PAGE 5>>>\n\nBen Smith\nSr. Multimodal DG Specialist • ProteQ\nmobile: (571) 449-0741\nemail: bsmith@proteq.com\n2325 Dulles Corner Blvd, Ste 725\nHerndon, VA 20171\nwww.proteq.com\nThis email and any attached files contain business sensitive information and are intended\nsolely for the use of the individual for whom they are addressed. If you are not the named\naddressee, do not disseminate, distribute or copy this email. Disclosing, copying, distributing\nor taking any action in reliance on the contents of this information is strictly prohibited. ProteQ\nis a Service Disabled Veteran Owned Small Business (SDVOSB) as certified by the U.S.\nDepartment of Veterans Affairs (VA) Center for Veterans Enterprise (CVE) verification\nprocess.","truncated":false,"body_characters":7029}