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Interpretation Response #17-0041

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

Interpretation Response Details

Response Publish Date:

Company Name: WNWN International

Individual Name: Mr. Ed Krisiunas

Location State: CT Country: US

View the Interpretation Document

Response text:

January 02, 2018
 
Ed Krisiunas
President
WNWN International
P.O. Box 1164
Burlington, CT  06013
 
Reference No. 17-0041
 
Dear Mr. Krisiunas:
 
This letter is in response to your April 25, 2017, emails requesting clarification of the Hazardous Materials Regulations (HMR; 49 CFR Parts 171-180) applicable to the transportation of regulated medical waste, specifically sharps containers and transport of those containers by a private carrier.
 
We have paraphrased and answered your questions as follows:
 
Q1.      You ask for confirmation of your understanding that the maximum size for a sharps container that meets part 178, subpart M packaging performance standards at the packing group (PG) II performance level is 40 gallons.
 
A1.      Packaging size limits for sharps containers are linked to use.  The 40-gallon limit you reference is associated with sharps containers intended to be reused as inner packagings of a Large packaging, a wheeled cart (Cart), or bulk outer packaging (BOP).  See § 173.197(e)(3).  If the sharps container is not intended to be reused, then the size limit is non-bulk.   See § 173.197(e)(3)(d)(1)(i); see also § 171.8 for the definition of non-bulk. 
 
Q2.      With respect to Q1, you ask for confirmation that a sharps container can be transported as a stand-alone container.
 
A2.      Based on our understanding that your intended meaning of "stand-alone container" is the container does not have to be placed in an outer packaging, then your understanding is correct.  Section 173.197(b) authorizes use of non-bulk packagings for transportation of sharps.  These packagings are not required to be placed in an outer packaging.
 
Q3.      You further ask if an 18-gallon sharps container meeting the PG II performance level can be the primary container of transport for sharps.
 
A3.      With the understanding that the meaning of "primary container" equates to "stand-alone container" in Q2, the answer is yes.  Regulated medical waste (i.e., sharps) may be transported in a single non-bulk packaging that must be a UN standard packaging that conforms to the requirements in part 178, subpart M at the PG II performance level.  See § 173.197(b) for a full description of performance requirements for the non-bulk packaging.    
 
Q4.      Finally, you explain that a private carrier, knowing the exceptions of § 173.134(c) for regulated medical waste, has a sharps container at the PG II performance level that is puncture resistant, and is filled with sharps, secured, but not placed in another container and then loaded in a motor vehicle.  You ask if this is acceptable in accordance with §§ 173.134 and 173.197.
 
A4.      The answer is yes if all applicable requirements of § 173.197 are met.
 
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
 
173.197(e)(3), 173.197(e)(3)(d)(1)(i), 171.8, 173.197(b), 178, 173.134(c), 173.134, 173.197

Regulation Sections

Section Subject
171.8 Definitions and abbreviations
173.134 Class 6, Division 6.2-Definitions and exceptions
173.197 Regulated medical waste
178 SPECIFICATIONS FOR PACKAGINGS