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Interpretation Response #03-0038 ([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:

Feb 28, 2003


Mr. John Bickel                Reference  No. 03-0038
Vice President
Statlab Medical Product
P.O. Box 1155
Lewisville, TX 75067

Dear Mr. Bickel:

This is in response to your January 30, 2003 letter regarding the classification of formaldehyde under the Hazardous Materials Regulations (HMR; 49 CFR Parts 171-180).  Specifically, you ask whether a solution of 4% formaldehyde mixed with non-hazardous materials shipped in 20 ml, 30 ml, 45 ml, 60 ml, and 120 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.  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.  However, in some situations, it may be necessary to enlist an outside laboratory to assist in the classification process as testing may have to be conducted to see how a product compares to the criteria for the various hazard classes.

I hope this satisfies your request.



Hattie L. Mitchell
Chief, Regulatory Review and Reinvention
Office of Hazardous Materials Standards


Regulation Sections

Section Subject
173.22 Shipper's responsibility