Statlab Medical Product — Hazardous Materials Safety Interpretation

Page 1of Transportation U.S. Department 400 Seventh St., SW Washington, D.C. 20590 Special Programs Research and Administration SEP - 4 2001 Mr. John Bickel Ref. 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. Sincerely, Gale Transportation Regulations Specialist Office of Hazardous Materials Standards 173.4 010184#

Page 207/16/2001 10:46 FAX 9724361369 STATLAB Statlab medical producio Lawlaville, TX 76057 106 Hillsido Dr. Phone 87-438-1010 x20 Emall jablckel@oratlab.com Fax 972-436-1369 Nelson 7/16/01 $173.4 Mr. Edward Mazzulo Director of Office of Hazardous Materials Standards Room 8422, 7th. St SW Department of Transportation smallquanitity Washington, DC 20590 01-0184 by fax: 202-366-3012 Dear Mr. Mazzulo: small quantities of formalin solution. I understand this issue has been addressed by your office I am requesting a revised letter of interpretation from you office regarding the transportation of previously (6/95 letter to J.G. McKay with SAF-T-PAK) but have additional information which may be of interest. formaldehyde with the balance being water and other non-hazardous materials. By way of clarification formalin solution (aka 10% formalin) typically consists of 3.7-4% of actual is generally packaged in small, screw-top plastic vials of various sizes for diagnostic purposes. formalin. I estimate that roughly 70 million of these vials are distributed to laboratories in the US, These vials are filled to 1/2 capacity, the smaliest of which fand most popular) contains 13mL of AEC/str-i,2most of which are shipped unrequlated by air. is quite clear that formaln solution in This dilurian meets neither the definition of UN2209 or UN1198. It has instead been casually classed as 8/22/011 UN3335 which leaves in subject to debate. Insotar as these formalin vials are generally shipped is that formalin solution does not meet any definition of hazardous material and is regarded unregulated by laboratories across the country i can't help but conclude that the collective opinion accordingly. To put another way, if this conclusion were inaccurate the economic and administrative impact would be tremendous to these laboratories. status and the other being the collective opinion across the country which departs from this So on the one hand there exists the latter of interpretation from your office suggesting class 9 interpretation. I believe this collective opinion is based on the notion that formalin solution at the 3.7-4% range does not rise to the level of being a substance "which has narcotic, noxious or other roperties such that, in the event of leakage or spillaga on an aircraftextreme annoyance o iscomfort could be caused to crew members so as to prevent the correct performance of assignec (note: the actual formaldehyde content per 13mL vial is less than .52mLl "This is particularly so given the very small volumes of materia! contained in these vials. and can ship unregulated by air as it does by ground. Can you please confirm this understanding or Accordingly, it is my opinion that 10% formalin solution does not meat the definition of a hazard state your objections? I would very much appreciate your timely response to this matter. Sincerely, John Bickel, VP#