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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 #21-0019

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

Interpretation Response Details

Response Publish Date:

Company Name: Burlington Products, Inc.

Individual Name: Bill Greene

Location State: NY Country: US

View the Interpretation Document

Response text:

May 26, 2021

Bill Greene
Burlington Products, Inc.
70 East Sunrise Highway
Suite 500
Valley Stream, NY  11581

Reference No. 21-0019

Dear Mr. Greene:

This letter is in response to your March 1, 2021, email, and subsequent phone conversation and email, requesting clarification of the Hazardous Materials Regulations (HMR; 49 CFR Parts 171-180) applicable to the packaging requirements for infectious substances.

We have paraphrased and answered your questions as follows:

Q1. You ask whether a plastic bag used as the primary receptacle or secondary packaging for the packaging of a Category A or B infectious substance is required to have a certified lab test the plastic bag to determine that it meets the capability performance standard of not leaking at an internal pressure of 95 kPa (0.95 bar, 14 psi).

The answer is no. Laboratory certification is not a specific condition of meeting the capability standard associated with the internal pressure requirement for primary or secondary packaging.

Q2. You ask what a bag manufacturer must do to satisfy the "must be capable of" requirement concerning a plastic bag's ability to meet a pressure requirement.

A2. The internal pressure requirement for a primary receptacle or secondary packaging used for Category A or Category B infectious substances is a capability performance standard. The HMR does not specify the manner in which this performance standard must be met. The bag manufacturer should use its expertise and knowledge regarding the design and materials used in the production of the packaging when making this determination in the absence of choosing to perform tests.

Q3. You ask what temperature must the plastic bag be conditioned to prior to pressure testing the primary or secondary plastic bag packaging used to ship infectious substances (Category A or B) by ground or air.

A3. The HMR does not specify temperature conditioning requirements associated with the performance of an internal pressure test for these packagings. However, with respect to Category A infectious substance packaging standards, the primary receptacle or secondary packaging must be capable of withstanding, without leakage, temperatures in the range of −40 °C to + 55 °C (−40 °F to + 131 °F) (see § 173.196(a)(7)). Furthermore, Category A infectious substance packaging must meet the test standards of § 178.609 for the completed package and is subject to conditioning requirements (see paragraphs (b) and (f)) for performance of certain tests. For Category B infectious substance packages, there is a standard that the effectiveness of the completed package must not be substantially reduced for minimum and maximum temperatures, normally encountered during transportation, as well as an integrity requirement associated with refrigerated or frozen specimens.

Q4. You ask whether a pressure-sustaining bag used as a component in a combination packaging, can be altered per §178.601(g)(4) without further testing.

A4. The selective testing and packaging variations of § 178.601(g), including paragraph (g)(4), are not applicable. Infectious substance packagings are subject to test requirements in § 178.609, which outlines authorized variations in the primary receptacle of a tested package in § 178.609(i).

Q5. What is the distinction in the regulations between a "leak-tight bag" and a "leakproof bag?"

A5. For the purposes of the HMR, there is a no distinction. The term "leakproof" is commonly used in the HMR in association with a test (i.e., leakproofness test) used to detect leaks in a packaging to ensure a package is free from leakage. "Leaktight" is another term that is used to describe a packaging, including its closures or valves, which is free from leakage.

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

Sincerely,

Dirk Der Kinderen
Chief, Standards Development Branch
Standards and Rulemaking Division

173.196(a)(7), 178.601(g), 178.601(g)(4), 178.609, 178.609(i)

Regulation Sections

Section Subject
173.196 Category A infectious substances
178.601 General requirements
178.609 Test requirements for packagings for infectious substances