Interpretation Response #24-0049
Below is the interpretation response detail and a list of regulations sections applicable to this response.
Interpretation Response Details
Response Publish Date:
Company Name: Clean Harbors
Individual Name: Mr. Paul Rheaume
Location State: TX Country: US
View the Interpretation Document
Response text:
December 18, 2024
Mr. Paul Rheaume
Clean Harbors
2130 E. Grauwyler Road
Irving, TX 75061
Mr. Kent Bongarzone
Cyn Environmental Services
100 Tosca Drive
Stoughton, MA 02072
Reference No. 24-0049
Dear Messrs. Rheaume and Bongarzone:
This letter is in response to your June 3, 2024, and June 11, 2024, letters requesting clarification of the Hazardous Materials Regulations (HMR; 49 CFR Parts 171-180) applicable to regulated medical waste (RMW).
We have paraphrased and answered your questions as follows:
Q1. In your June 11, 2024, letter you describe a scenario where urine cups are re-capped after laboratory testing is completed. The urine cups—containing liquid contents—are further placed in red bags with a single knot and then placed in 31-gallon RMW containers with folding clamshell lids. You ask whether the above-described packaging is in compliance with § 173.134(b)(12)(ii).
A1. The answer is no, as the provisions in § 173.134(b)(12)(ii) apply to "used health care products" being returned to the manufacturer or the manufacturer’s designee. Patient specimens being transported for disposal do not meet this criterion.
Q2. In your June 3, 2024, letter you describe a scenario where liquid bodily fluid contained in screw-top leak-resistant containers is classed as "UN3291, Medical waste, n.o.s., 6.2." The containers are packaged in UN4H2 plastic boxes in accordance with § 173.197(b). You further state that the cups are braced or cushioned to prevent shifting or damage. You ask whether the above packaging scenario is authorized under § 173.197(b).
A2. The answer is yes. Provided—as you describe in your letter—there are no sharps or foreign articles present, materials properly classed under "UN3291, Medical waste, n.o.s., 6.2" may be transported in UN standard packagings conforming to the requirements of part 178 of the HMR.
I hope this information is helpful. Please contact us if we can be of further assistance.
Sincerely,
Alexander Wolcott
Acting Chief, Regulatory Review and Reinvention Branch
Standards and Rulemaking Division
173.134(b)(12)(ii), 173.197(b)