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Interpretation Response #18-0159

Below is the interpretation response detail and a list of regulations sections applicable to this response.

Interpretation Response Details

Response Publish Date:

Company Name: Dorsey and Whitney LLP

Individual Name: Mark R. Kaster

Location State: MN Country: US

View the Interpretation Document

Response text:

May 2, 2019

Mark R. Kaster
Partner
Dorsey and Whitney LLP
50 South Sixth Street
Suite 1500
Minneapolis, MN 55402-1498

Reference No. 18-0159

Dear Mr. Kaster:

This letter is in response to your December 13, 2018, email requesting clarification of the Hazardous Materials Regulations (HMR; 49 CFR Parts 171-180) applicable to hazard communication requirements for packages containing lithium button cell batteries installed in equipment. You describe a blood glucose monitoring device that contains lithium metal button cell batteries of a type that meets the criteria in the United Nations (UN) Manual of Tests and Criteria Part III, Sub Section 38.3. You state that each device is placed in its own boxed packaging for retail distribution and sale, which is then placed in an overpack. Each overpack contains 12–24 retail units. Specifically, you ask whether packages containing lithium button cell batteries installed in equipment must display the lithium battery mark in accordance with § 173.185(c)(3).

The answer is no. Packages containing only lithium button cell batteries installed in equipment, including the button cells in your blood glucose monitoring devices, that comply with the requirements of § 173.185(c) are not required to display the lithium battery mark. This applies regardless of the number of packages per consignment, the number of pieces of equipment per package, or the number of lithium button cell batteries installed in each piece of equipment.

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

Sincerely,

T. Glenn Foster
Chief, Regulatory Review and Reinvention
Standards and Rulemaking Division

173.185(c)(3), 173.185(c)

Regulation Sections

Section Subject
173.185 Lithium cells and batteries