{"operation":"document","citation":"23-0076","title":"Mr. Tristan Amberger — Hazardous Materials Safety Interpretation","source_type":"guidance","agency":"Pipeline and Hazardous Materials Safety Administration","status":"guidance","official":true,"published_on":"2024-04-15","effective_on":null,"summary":"23-0076 concerning 173.22.","machine_formats":{"json":"https://regulus.evalyn.ai/document/phmsa-interpretation-23-0076.json","markdown":"https://regulus.evalyn.ai/document/phmsa-interpretation-23-0076.md"},"app_url":"https://regulus.evalyn.ai/document/phmsa-interpretation-23-0076","source_url":"https://www.phmsa.dot.gov/sites/phmsa.dot.gov/files/2025-01/230076.pdf","body":"<<<PAGE 1>>>\n\nU.S. Department\nof Transportation\nPipeline and Hazardous\nMaterials Safety\nAdministration\nApril 15, 2024\n1200 New Jersey Avenue, SE\nWashington, DC 20590\nMr. Tristan Amberger\n2007 Eastlake Ave E\nApt 31\nSeattle, WA 98168\nReference No. 23-0076\nDear Mr. Amberger:\nThis letter is in response to your August 18, 2023, email requesting clarification of the\nHazardous Materials Regulations (HMR; 49 CFR Parts 171-180) applicable to lithium batteries.\nWe have paraphrased and answered your questions as follows:\nQ1. You ask what the definition of “production run” is for lithium batteries under the HMR.\nA1. The HMR does not define the term “production run” for lithium batteries. However, the\nword “production run” can be understood from the individual meaning of the words\n“production” and “run.” The Merriam-Webster dictionary defines “production” as “the\ntotal output especially of a commodity or an industry” and “run” as “to continue in force,\noperation, or production.” In the context of lithium batteries, a “production run” can be\ninterpreted as the total quantity or batch of lithium batteries produced during a specific\nperiod of manufacturing operations.\nIt is important to note that § 173.22 of the HMR places the responsibility on the shipper\nto properly classify and package hazardous materials, including lithium batteries. While\nthe term “production run” is not explicitly defined, the HMR provides specific\nrequirements for the packaging and testing of lithium batteries based on their lithium\ncontent and other characteristics, which may be relevant in determining what constitutes\na “production run” for compliance purposes.\nQ2. You ask whether a change in the design of a lithium battery or a change in the lithium\nbattery production process constitutes a new production run.\nA2. The answer depends on the specific changes to the design of the lithium battery or the\nlithium battery production process. The determination of criteria that triggers a new\nproduction run is ultimately up to the manufacturer. However, in general, changes to a\ncell or battery design or production process equivalent to those found in section 38.3.2.2\nof the UN Manual of Tests and Criteria could indicate a new production run.\nQ3. You ask whether the replacement of a lithium battery cooling fan with a newer model\ncooling fan would constitute a new production run.\n\n<<<PAGE 2>>>\n\nA3. See answer A2. This determination is the responsibility of the manufacturer.\nQ4. You ask whether transitioning from a sealing process that relies on a technician\nphysically sealing a lithium battery component to a process that utilizes a validated\nautomated procedure with a robotic dispenser is considered a new production run.\nA4. See answer A2. This determination is the responsibility of the manufacturer.\nI hope this information is helpful. Please contact us if we can be of further assistance.\nSincerely,\nSteven W. Andrews Jr.\nActing Chief, Regulatory Review and Reinvention Branch\nStandards and Rulemaking Division\n\n<<<PAGE 3>>>\n\nVore\n23-0076\nSent: Monday, August 14, 2023 6:28 PM\nTo: INFOCNTR (PHMSA)\n<INFOCNTR.INFOCNTR@dot.gov> Subject: Request for\nLOI\nCAUTION: This email originated from outside of the Department of Transportation (DOT). Do\nnot click on links or open attachments unless you recognize the sender and know the content\nis safe.\nDear Sir or Madam,\nI was hoping to get a letter of interpretation regarding the definition of a \"production run\" as it is\nstated in 49 CFR 173.185(e)\nI found LOI 17-0071, which clearly stipulates that the quantity defined as a low production run is no\nmore than 100 units. With that stated and understood, what defines the \"production run\" itself?\nBased off of freely available information, I could define a production run as \"all of the processes\nnecessary to manufacture a certain product\" (Harper Collins online)\nDoes a change in the design of the battery itself or a change to the production process constitute a\nnew production run?\nBattery design example:\nDue to a quality issue, Manufacturer XYZ updated the design of Battery XYZ 1.0 to replace a model of\ncooling fan for a newer cooling fan that of higher quality. Does that design change constitute a new\nproduction run?\n\n<<<PAGE 4>>>\n\nProduction process example:\nManufacturer XYZ has produced 85 units of a battery with a sealing process that involved a\ntechnician to seal a component of the battery by hand. After validation of an automated procedure\nusing a robotic dispenser, they update the production process to use the robot instead of the\ntechnician. Does the change to the production process count as a new production run?\nIf any of these conditions COULD constitute a new production run, what steps would the\nmanufacturer have to take to define a new production run of a battery?\nThanks,\nTristan Amberge","truncated":false,"body_characters":4814}