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U.S. Department of Transportation U.S. Department of Transportation Icon United States Department of Transportation United States Department of Transportation

Interpretation Response #23-0067

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

Interpretation Response Details

Response Publish Date:

Company Name: Andelyn Biosciences

Individual Name: Dave Curl

Location State: OH Country: US

View the Interpretation Document

Response text:

May 1, 2024

Dave Curl
Andelyn Biosciences
1180 Arthur E. Adams Dr.
Columbus, OH  43221

Reference No. 23-0067

Dear Mr. Curl:

This letter is in response to your July 6, 2023, email requesting clarification of the Hazardous Materials Regulations (HMR; 49 CFR Parts 171-180) applicable to infectious substances. In your email, you state that your company transports "UN3373, Biological substance, Category B, 6.2" with dry ice in a non-specification packaging in conformance with § 173.199. You note that this includes conformance with the § 178.609(d) drop tests, as required in § 173.199(a)(4). You state that your company would like to add additional mylar bags to the inner packaging that were not present when the drop tests were completed. You ask whether this modification to the inner packaging would require the entire package configuration to be retested.

The answer is no. Section 173.199 prescribes the packaging requirements for a Division 6.2 Category B infectious substance. This section requires that a Category B infectious substance be packaged in a triple packaging that is designed, constructed, and maintained so that under conditions normally encountered in transportation, there will be no release of the hazardous material into the environment. The package must also be capable of passing the drop tests in § 178.609(d), in accordance with § 173.199(a)(4); however, it does not require retesting and is not subject to the design qualification testing, periodic retesting, or record retention (i.e., test report requirements) in § 178.601. It is the opinion of this Office that the minor revisions to the inner packaging configuration as described in your email would not require the entire package configuration to be retested.

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

173.199, 173.199(a)(4), 178.601, 178.609(d)

Regulation Sections

Section Subject
173.199 Category B infectious substances
178.601 General requirements
178.609 Test requirements for packagings for infectious substances