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The Pipeline and Hazardous Materials Safety Administration (“PHMSA”) responded in a June 3rd letter to a request for clarification of the Hazardous Materials Regulations (“HMR”) applicable to the design qualification testing of a package used for infectious substances.

PHMSA was responding to a February 5th request from the U.S. Military Surface Deployment and Distribution Command (“Distribution Command”).

The Distribution Command asked for clarification of the condition requirements for test samples in:

. . . §§ 178.609(f), 178.603(c)(1), 178.810(b)(4), and 178.965(c) as they apply to Category A packaging constructed of plastic.

Distribution Command interpreted the condition requirements in § 178.609(f) to be the same as those specified in:

• § 178.603(c)(1)
• §178.810(b)(4)
• §178.965(c)

Section 178.609(f) requires that the conditioning period be sufficient to ensure that the test sample (i.e., the packaging and its contents) has been reduced to -18 °C or lowered prior to performing the drop test.

The Distribution Command interprets the phrase “a period of at least 24 hours” to be:

. . . the minimum required amount of time for conditioning the test sample.

The organization also believes the conditioning period must continue past 24 hours if the test sample has not been fully reduced to -18 °C or lower at the end of the initial 24 hour conditioning period.

PHMSA responds that the Distribution Command is correct that “testing of packaging under § 178.609(f) requires a period of 24 hours for conditioning a test sample of -18 °C.” It also states that the Distribution Command is correct that:

. . . the conditioning period under § 178.609(f) would continue past 24 hours if the test sample has not been fully reduced to -18 °C or lower.

PHMSA does state, however, that:

. . . such a time is not specified in §§ 178.603(c)(1), 178.810(b)(4), and 178.965(c). Packages tested under these sections of the HMR must have the test samples fully reduced to -18 °C or lower, but there is no specified minimum time frame for doing so.

A copy of the interpretive letter can be found here.