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Interpretation Response #01-0184 ([Statlab Medical Product] [Mr. John Bickel])

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

Interpretation Response Details

Response Publish Date:

Company Name: Statlab Medical Product

Individual Name: Mr. John Bickel

Location State: TX Country: US

View the Interpretation Document

Response text:

September 4, 2001


Mr. John Bickel                              Reference No. 01-0184
Vice President
Statlab Medical Product
P.O. Box 1155
Lewisville, TX 75067

Dear Mr. Bickel:

This is in response to your July 16, 2001 letter and subsequent telephone conversation with Eric Nelson of my staff regarding the classification of formaldehyde under the Hazardous Materials Regulations (HMR; 49 CFR Parts 171-180).  Specifically, you cite a June 6, 1995 letter sent from this Office to J. G. McKay, and ask if a solution of 3.7 to 4% formaldehyde mixed with non-hazardous materials shipped in 13 ml vials by aircraft are subject to the HMR.

Based on subsequent information you provided to this Office, it is our opinion that your products are not subject to the requirements of the HMR.  The letter you refer to addresses 10% formaldehyde solutions, which meet the definition of a Class 9 hazardous material.  Generally, solutions of less than 10% formaldehyde mixed with non-hazardous materials do not meet the definition of a Class 9 hazardous material and, provided they do not meet any other hazard class, are not subject to the HMR.  However, as provided by § 173.22 of the HMR, it is the shipper’s responsibility to properly class a hazardous material.  Generally, manufacturers have the knowledge to properly class the materials and products they produce, although it may be necessary to enlist an outside laboratory to assist in classification process, as testing may have to be conducted to see how a product compares to the criteria for various hazard classes.

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