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Interpretation Response #18-0131

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

Interpretation Response Details

Response Publish Date:

Company Name: VA Pacific Islands Health Care System (119)

Individual Name: Chaz Barit, Pharm.D.

Location State: HI Country: US

View the Interpretation Document

Response text:

April 22, 2019

Chaz Barit, Pharm.D.
VA Pacific Islands Health Care System (119)
459 Patterson Road
Honolulu, HI  96819

Reference No. 18-0131

Dear Dr. Barit:

This letter is in response to your October 11, 2018, letter requesting clarification of the Hazardous Materials Regulations (HMR; 49 CFR Parts 171-180) applicable to ground and/or air shipments of pharmaceuticals throughout the Hawaiian Islands.  Specifically, you provided safety data sheets that describe two products and ask how they should be transported.  You note in your letter that the products described meet no other hazardous material classification (e.g., marine pollutant).  We have paraphrased and answered your questions below.

You describe Product 1 as a gel that contains 20% isopropanol, has a flashpoint of 18.5 ºC (65.3 ºF), and is classed as “UN1987, Alcohols, n.o.s., Class 3 (flammable liquid), Packing Group (PG) III.”  You asked the following five questions about this material.

Q1.    You ask if Product 1 can be reclassified as a combustible liquid (alcohol < 24%) in conformance with § 173.150(e)(1) for transportation by aircraft.  

A1.   Yes.  An aqueous solution containing 24% or less alcohol by volume and no other hazardous materials may be reclassed as a combustible liquid regardless of the mode of transport provided it complies with § 173.150(e)(1).  Additionally, combustible liquids transported in “non-bulk” packagings—as defined in § 171.8—are only subject to the HMR if they meet the definition of a hazardous substance, hazardous waste, or marine pollutant (see § 173.150(f)(2)). 

Q2.   You ask if it is necessary to consider the flashpoint (referenced in § 173.150(f)) of Product 1 if it is reclassified in conformance with the exception in § 173.150(e)(1).

A2.   No.  The subparagraphs in § 173.150(e) stand alone.  Therefore, for the reasons discussed in Answer A1, an aqueous solution containing 24% or less alcohol by volume and no other hazardous material may be reclassed as a combustible liquid.  If the solution contains 50% or more water, it is excepted from the HMR (see § 173.150(e)(2)).

Q3.   You seek confirmation of your understanding that Product 1 is excepted from the HMR when reclassified as a combustible liquid and placed in a non-bulk packaging provided the product is not a hazardous substance, hazardous waste, or marine pollutant. 

A3.   Your understanding is correct.  See Answer A1.

Q4.   You ask if Product 1 must qualify for the exception in § 173.150(f)(1) before it can be considered for the exception prescribed in paragraph (f)(2) of this section.

A4.   No.  See Answer A2.

Q5.   You seek confirmation of your understanding that Product 1 is not subject to the HMR and may be transported in commerce to patients in the State of Hawaii by railcar, motor vehicle, or aircraft.

A5.   Your understanding is correct.  See Answer A1.

You describe Product 2 as a gel that contains 55–70% ethanol, has a flashpoint of 21.7 ºC (71.06 ºF), and is classed as “UN1170, Ethanol solution, Class 3, PG II.”  You asked the following two questions about this material.

Q6.   You ask if Product 2 is excepted from the HMR under § 173.150(g)(1).

A6.   Provided all the applicable requirements in § 173.150(g)(1) are met, the answer is yes.

Q7.   You seek confirmation of your understanding that Product 2 is not subject to the HMR and may be transported in commerce to patients in the State of Hawaii by railcar, motor vehicle, or aircraft provided the shipment complies with §§ 173.150(g)(1)(i)–(iii) and 173.150(g)(3)(i).

A7.   Your understanding is correct.  See Answer A6.

I hope this information is helpful.  Please contact us if we can be of further assistance.

Sincerely,

T. Glenn Foster
Chief, Regulatory Review and Reinvention Branch
Standards and Rulemaking Division
173.150(e)(1), 171.8, 173.150(f)(2), 173.150(f), 173.150(e)(2), 173.150(e), 173.150(f)(1), 173.150(g)(1), 173.150(g)(1)(i)–(iii), 173.150(g)(3)(i)

 

 

Regulation Sections

Section Subject
171.8 Definitions and abbreviations
173.150 Exceptions for Class 3 (flammable and combustible liquids)