Low Production Run Clarifications

April 15, 2024

Reference No. 23-0076

This letter is in response to your August 18, 2023, email requesting clarification of the Hazardous Materials Regulations (HMR; 49 CFR Parts 171-180) applicable to lithium batteries.

We have paraphrased and answered your questions as follows:

Q1. You ask what the definition of “production run” is for lithium batteries under the HMR.

A1. The HMR does not define the term “production run” for lithium batteries. However, the word “production run” can be understood from the individual meaning of the words “production” and “run.” The Merriam-Webster dictionary defines “production” as “the total output especially of a commodity or an industry” and “run” as “to continue in force, operation, or production.” In the context of lithium batteries, a “production run” can be interpreted as the total quantity or batch of lithium batteries produced during a specific period of manufacturing operations.

It is important to note that § 173.22 of the HMR places the responsibility on the shipper to properly classify and package hazardous materials, including lithium batteries. While the term “production run” is not explicitly defined, the HMR provides specific requirements for the packaging and testing of lithium batteries based on their lithium content and other characteristics, which may be relevant in determining what constitutes a “production run” for compliance purposes.

Q2. You ask whether a change in the design of a lithium battery or a change in the lithium battery production process constitutes a new production run.

A2. The answer depends on the specific changes to the design of the lithium battery or the lithium battery production process. The determination of criteria that triggers a new production run is ultimately up to the manufacturer. However, in general, changes to a cell or battery design or production process equivalent to those found in section 38.3.2.2 of the UN Manual of Tests and Criteria could indicate a new production run.

Q3. You ask whether the replacement of a lithium battery cooling fan with a newer model cooling fan would constitute a new production run.

A3. See answer A2. This determination is to the responsibility of the manufacturer.

Q4. You ask whether transitioning from a sealing process that relies on a technician physically sealing a lithium battery component to a process that utilizes a validated automated procedure with a robotic dispenser is considered a new production run.

A4. See answer A2. This determination is the responsibility of the manufacturer.

I hope this information is helpful. Please contact us if we can be of further assistance.

Sincerely,

Steven Andrews
Acting Chief, Regulatory Review and Reinvention Branch
Standards and Rulemaking Division

173.22