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Interpretation Response #01-0101 ([BD Preanalytical Solutions] [Ms. M. Wendy Bosshardt])

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

Interpretation Response Details

Response Publish Date:

Company Name: BD Preanalytical Solutions

Individual Name: Ms. M. Wendy Bosshardt

Country: US

View the Interpretation Document

Response text:

AUG 20, 2001


Ms. M. Wendy Bosshardt                      Ref. No. 01-0101
Regulatory Affairs Specialist
BD Preanalytical Solutions
1 Becton Drive
Franklin Lakes, NJ 07417

Dear Ms. Bosshardt:

This is in response to your April 24, 2001, letter and subsequent telephone conversation with a member of my staff, requesting clarification on the small quantity exception under the Hazardous Materials Regulations (HMR; 49 CFR Parts 171-180). Specifically, you ask if a vacuum (i.e., negative pressure) in each receptacle and shrink wrap around the tray and stoppered tubes meet the requirement for a positive closure as specified in § 173.4(a) (3) of the HMR. You sent in a sample packaging for our review.

To qualify for the small quantity exception, each inner receptacle with a removable closure must have the closure held securely in place with wire, tape, or other positive means.
[§ 173.4(a) (3)] Negative pressure in a receptacle is not a positive means of closure. However, shrink wrap around the tray which securely holds each tube's closure in place may be used to satisfy the requirement of § 173.4(a) (3). Based on the sample which you submitted we note that the shrink wrap is placed loosely over the test tubes and may not ensure that test tubes in the center of the tray have their closures held in place by positive means. This could easily be corrected by placing a piece of fiberboard or other such material over the test tubes before the shrink wrap is affixed or by placing the shrink wrap tightly around the test tubes.

I hope this satisfies your request.



John A. Gale
Transportation Regulations Specialist
Office of Hazardous Materials Standards


Regulation Sections

Section Subject
173.4 Small quantities for highway and rail