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Interpretation Response #00-0229 ([Artegraft, Inc.] [Ms. Cathy VanDerVeer])

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

Interpretation Response Details

Response Publish Date:

Company Name: Artegraft, Inc.

Individual Name: Ms. Cathy VanDerVeer

Location State: NJ Country: US

View the Interpretation Document

Response text:

October 3, 2000

 

Ms. Cathy VanDerVeer                   Reference No. 00-0229
Artegraft, Inc.
P.O. Box 7305
North Brunswick, NJ 08902

Dear Ms. VanDerVeer:

I am responding to your August 11, 2000 letter regarding the definition of a consumer commodity the Hazardous Materials Regulations (HMR; 49 CFR Parts 171-180) as it applies to Artegraft's under alcohol based “Sterilizing Solution.”

You stated that your company’s sterilizing solution is an alcohol based sterilant utilized in the manufacturing process of an Artegraft.  An Artegraft is an all collagen vascular access graft used by physicians.  The sterilizing solution is 50% ethyl alcohol with the remaining balance being water.  The product is a Class 3 (flammable liquid) in Packing Group III, in accordance with §§ 173.120 and 173.121, and described as “Ethyl alcohol solutions.”

The product is packaged in 500-milliliter inner containers, placed in a Styrofoarn box, and then packaged in an outer fiberboard box.  The boxes are overpacked in a fiberboard box with a higher burst/edge crush strength.  The outer packaging contains from 1 to 10 units depending upon the quantities ordered.  The total weight of the packages range from 4 pounds to 34 pounds.  Specifically, because the components of Artegraft’s sterilant are similar to many alcohol based household sterilants, you believe that the alcohol based sterilizing solution meets the definition of “Consumer commodity, ORM-D.”

The definition of a consumer commodity in § 171.8 includes a material that is packaged and distributed in a form suitable for retail sale for consumption by individuals for purposes of personal use or household use even if not specifically so intended, We agree that the Artegraft alcohol based sterilizing solution described in your letter is suitable for household use and qualifies to be described and classed as a “Consumer commodity, ORM-D.”

I hope this satisfies your inquiry.  If we can be of further assistance, please contact us.

Sincerely,

 

Delmer F. Billings
Chief, Regulations Development
Office of Hazardous Materials Standards

171.8

Regulation Sections

Section Subject
171.8 Definitions and abbreviations