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Interpretation Response #98-0131 ([Saf-T-Pak, Inc.] [Mr. Eric Cook])

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

Interpretation Response Details

Response Publish Date:

Company Name: Saf-T-Pak, Inc.

Individual Name: Mr. Eric Cook

Country: CA

View the Interpretation Document

Response text:

SEP 22, 1998


Mr. Eric Cook                         Ref. No. 98-0131
Saf-T-Pak, Inc.
101, 17872-106 Avenue
Edmonton, Alberta T5S 1V4

Dear Mr. Cook:

This is in response to your letter dated June 2, 1998, regarding the marking requirements for infectious substance packagings manufactured in the United States.  Your questions have been paraphrased and answered as follows.

Q1.  Is it correct that a UN specification mark is not required on packaging manufactured or used in the United States for infectious substances?

A1.  Yes.  Infectious substance packagings manufactured in the United States are not required to have package specification markings under the Hazardous Materials Regulations (HMR; 49 CFR Part 171-180).  As you state in your letter, § 178.609(i) excepts packagings that meet the test requirements in that section from the marking requirements of § 178.503 and all other requirements of Subpart N of Part 178, except for
§ 178.608 (the vibration standard). 

Infectious substance packages transported in the United States by aircraft under § 171.11, or by vessel under 171.12, must be marked with the appropriate UN specification mark.  International markings for such packagings, including the markings required under the International Civil Aviation Organizations Technical Instructions for the Transport of Dangerous Goods by Air (ICAO Technical Instructions) and the International Maritime Dangerous Goods Code (IMDG Code), are acceptable to the DOT provided test records show that the test requirements of § 178.609 have been met. 

Q2.  If a hazardous materials packaging manufacturer in the United States were to put a UN specification mark on an infectious substance packaging manufactured in the United States, what would this marking designate? 

A2.  If the mark is as prescribed in the ICAO Technical Instructions or the IMDG Code, the mark designates that the packaging conforms to the UN specification packaging criteria contained in those regulations.  Also, enclosed is a recently published advance notice of proposed rulemaking concerning infectious substance requirements. 

I hope this satisfies your request.



Hattie L. Mitchell, Chief
Regulatory Review and Reinvention
Office of Hazardous Materials Standards



Regulation Sections

Section Subject
173.196 Category A infectious substances