Statlab Medical Product — Hazardous Materials Safety Interpretation

Page 1U.S. Department FEB 28 2003 of Transportation 400 Seventh St., S.W. Washington, D.C. 20590 Mr. John Bickel Vice President Ref. No. 03-0038 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. Sincerely, Hothe smithel Hattie L. Mitchell Office of Hazardous Materials Standards Chief, Regulatory Review and Reinvention 173.22 030038#

Page 201/30/2003 15:20 FAX 8724361369 STATLAB Betts @002 Statlab medical produc 03-0038 Phone 07-436-1010 X20 Lewisville, TX 75057 Fax 072-435-1389 Emall jdbickalSntattab.com 1/30/03 Mr. Edward Mazzulo Director of Office of Hazardous Materials Standards Department of Transportation Washington, DC 2059D Room 8422, 7th. St SW by fax: 202-386-3012 Dear Mr. Mazzulo: I am requesting a revised letter of interpretation from you office regarding the transportation of small quantities of formalin solution. Please reference your letter (01-0184) dated 9/4/01 and the original It is my opinion that Mr. Gale agreed that for the specified material (4% formaldehyde and balance being would not be a regulated material when shipped by air. If this is correct my follow up question deals with water and other non-hazardous materials aka. 10% formalin solution) in unit volumes* of 13mL that these It is my view that 10% formalin in any of the above referenced volumes would not be regulated when appreciate your timely response 1o this matter. shipped by air. Can you please confim this understanding or state your objections? I would very much Sincerely. John Bickel, VP *all referenced units are packaged in plastic screw top vials which have passed the 95kPa pressure test.#

Page 301/30/2003 15:21 FAX 9724361369 STATLAB 41003 Stotlab medical producto 106 Hillside Dr. Phone 97-436-1010 x20 Lewisville, TX 75057 Email Jdbickel@statlab.com Fax 972-436-1369 7/16/01 Mr. Edward Mazzulo Director of Office of Hazardous Materials Standards Room 8422, 7th. St SW Department of Transportation Washington, DC 20590 by fax: 202-366-3012 Dear Mr. Mazzulo: I am requesting a revised letter of interpretation from you office regarding the transportation of small (6/95 letter 10 J.G. McKay with SAF-T-PAK) but have additional information which may be of interest. quantities of formalin solution. I understand this issue has been addressed by your office previously formaldehyde with the balance being water and other non-hazardous materials. Formalin solution is By way of clarification formalin solution (aka 10% formalin) typically consists of 3.7-4% of actual generally packaged in small, screw-top plastic vials of various sizes for diagnostic purposes. These vials that roughly 70 million of these vials are distributed to laboratories in the US, most of which are shipped are filled to 1/2 capacity, the smallest of which (and most popular) contains 13mL of formalin. I estimate UN2209 or UN1198. It has instead been casually classed as UN3335 which leaves it subject to debate. unregulated by air. It is quite clear that formalin solution in this dilution meets neither the definition of Insofar as these formalin vials are generally shipped unregulated by laboratories across the country I hazardous material and is regarded accordingly. To put another way, if this conclusion were inaccurate can't help but conclude that the collective opinion is that formalin solution does not meet any definition of the economic and administrative impact would be tremendous to these laboratories. the other being the collective opinion across the country which departs from this interpretation. I believe So on the one hand there exists the letter of interpretation from your office suggesting class 9 status and the level of being a substance "which has narcotic, noxious or other properties such that, in the event of this collective opinion is based on the notion that formalin solution at the 3.7-4% range does not rise to as to prevent the correct performance of assigned duties." leakage or spillage on an aircraft extreme annoyance or discomfort could be caused to crew members so This is particularly so given the very small toan 52 of material contained in these vials. (note: the actual formaldehyde content per 13mL vial is less Accordingly, it is my opinion that 10% formalin solution does not meet the definition of a hazard and car objections? I would very much appreciate your timely response to this matter. hip unregulated by air as it does by ground. Can you please confim this understanding or state your Sincerely, Jonn Bickel, VP#

Page 4.. 01/30/2003 15:22 FAX 9724361369 STATLAB 0004 400 Seventh St., S.W. Research and Washington. D.C. 20590 Some ration s SEP - 4 2001 Mr. John Bickel Vice President Ref. No. 01-0184 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 Neison of my staff regarding the classification of formaldehyde under the Hazardous Materials Regulations J. G. McKay, and ask if a solution of 3.7 to 4% formaldehyde mixed with non-hazardous materials (HMR; 49 CFR Parts 171-180). Specifically, you cite a June 6, 1995 letter sent from this Office to 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 requiremants of the HMR. The letter you refer to addresses 10% formaldehyde solutions, which meet the definition of a Class 9 hazardous material. Gencrally, 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 FMR. 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 criteria for various hazard classes. classification process, as testing may have to be conducted to see how a product compares to the I hope this satisfies your request. Sincerely, • Gale Transportation Regulations Specialist Office of Hazardous Materials Standards#