PHMSA letter of interpretation

Packagings for Regulated Medical Waste

Pipeline and Hazardous Materials Safety Administration · Oct 16, 2001 · Reference No. 01-0201

Interprets: 49 CFR § 178.3

This responds to your letter of July 16, 2001, requesting clarification on manufacturing packagings for regulated medical waste (RMW) under the Hazardous Materials Regulations (HMR; 49 CFR Parts 171-180). You state that your company manufactures packagings for RMW but you do not provide the inner receptacles. You provide instructions stating:

- Only solids may be hauled (no semi-liquids or liquids);
- Gross weight may not exceed 27.2 kilograms;
- A 3 mil inner liner must be used (top gathered and tied in a single knot);
- Must be transported by private or contract motor carrier.

Your questions are paraphrased and responded to as follows:

Ql. Should any reference and/or restriction be made as to particulars of the "solids" being
transported? How close to the type of "mix" tested is the end user required to apply to their "mix" to be hauled?

Al. Any mixture of solid materials may be transported in the above described container provided the maximum gross weight as marked on the packaging is not exceeded, however, the packaging may not be used for sharps unless it has been tested as such. For your information, the Food and Drug Administration also has requirements for sharps containers.

Q2. May pressure sensitive labels be used for marking a packaging? Is there a performance test that labels need to meet?

A2. Pressure sensitive labels may be used for marking a package. There is no performance test for such labels.

A letter of interpretation applies the regulations to the facts the requester described. It isn’t a regulation and isn’t legal advice. The agency’s copy.