ARUP Laboratories — Hazardous Materials Safety Interpretation

Page 1400 Seventh St., S.W. Washington, D.C. 20590 NOV 18 2004 Mr. Paul Brinton Reference No. 04-0216 Vice President, Transportation & Logistics ARUP Laboratories 500 Chipeta Way Salt Lake City, Utah 84108 Dear Mr. Brinton: This is in further response to your August 27, 2004 e-mail concerning how to properly describe and label an unknown fungus suspected of being an infectious substance under the Hazardous Materials Regulations (HMR; 49 CFR Parts 171-180). We responded to your e-ma: I in a letter dated September 20, 2004. In your August 27 e-mail, you stated that you are shipping an unknown fungus suspected "fungus" raay be used to meet the requirements for a technical name in accordance with of being an infectious substance to a laboratory for testing. You asked if the term response, ive suggested that you use the term "mycotic species" as the technical name to §§ 171.8, 72.101(b)(4), and 172.203(k) of the HMR. In our September 20, 2004 complete the generic shipping description for the suspected infectious substance. In a community uses the terms "fungus" and "mycotic species" interchangeably and defines September 23, 2004 e-mail responding to our letter, you note that the sciertific "mycotic" to mean "... infection with or disease caused by a fungus." Based on the information you provided, we agree that either "fungus" or "mycotic species" may be used to comply with the technical name requirements in § 172.101(b)(4) for transportation of an unknown fungus described and classed as an "Infectious substance, affecting humans, 6.2, UN 2814." We note concerning the shipping description of unknown samples of hazardous materials your sample a tentative proper shipping name, hazard class, identification number, and being transported for testing that, in accordance with § 172.101(c)(11), you may assign packing group, if applicable, and offer it for transportation for testing to determine its hazard class. You must assign a proper shipping name based on your knowledge of the material ard the hazard precedence prescribed in § 173.2a. In addition, if the word "sample" is not already included in the proper shipping name, you must add it to the proper shipping name or place it in close proximity to the basic shipping description. Thus, for the fungus you are shipping, the shipping description would be "Sample infectious substance, affecting humans, 6.2, UN 2814." For samples transported in accordance with this section, the provisions requiring a technical name for the constituen (s) of the material do not apply (see § 172.101(c)(iv)(B)). 171.8 040216 112.203 (к)#

Page 2You also ask if the wording "Suspected Category A Infectious Substance" and the packaging and hazard communication prescribed in the 2005-2006 edition of the International Civil Aviation Organization (ICAO) Technical Instructions for the Transport of Dangerous Good by Air (Technical Instructions) may be used now to transport the fungus you described or if you must wait until January 1, 2005, to use these requirements. The ICAO does not authorize the use of these requirements until January 1, 2005. (See the foreword of the ICAO Technical Instructions in the section describing their operational use.) Under § 171.11, the HMR permit the use of the 2003- 2004 edition of the ICAO Technical Instructions, as incorporated by reference in § 171.7, as an alternative to the requirements prescribed in the HMR for air shipments, with certain exceptions. In a notice of proposed rulemaking we issued in the Federal Register on June 22, 2004 (Docket No. RSPA-04-17036 (HM-215G), 69 FR 34724), we proposed to revise this incorporation by reference to permit the use of the 2005-2006 edition of the ICAO Technical Instructions. We expect to publish the rule in time to authorize use of the 2005-2006 edition ICAO Technical Instructions under the HMR by January 1, 2005. I hope this information is helpful. Sincerely, Director, Office of Hazardous Edward T. Mazzullo Materials Standards#

Page 3Infectious Substance Technical Names Edmonson Page 1 of 2 $ 171.8 4/14/04 Drakeford, Carolyn § 172.203 (к) From: Edmonson, Eileen Technical Nanues Sent: Monday, September 13, 2004 1:16 PM To: Drakeford, Carolyn 04-0216 Subject: FW: Irfectious Substance Technical Names letter writer. Thanks, Eileen Carolyn - Please og this letter into the System. I've prepared a draft and am waiting for a call back from the From: Mazzullo, Ed ----Original Message--. To: Edmonson, Eileen Sent: Tuesday, September 07, 2004 11:23 AM Cc: Gorsky, Susan; Mitchell, Hattie; Mazzullo, Ed Subject: FW: Infectious Substance Technical Names Please handle. Ed -----Original Message----- Sent: Friday, August 27, 2004 1:39 PM From: Brinton, Paul [mailto:brintoph@aruplab.com] To: Mazzullo, Ed <RSPA> Subject: Infectious Substance Technical Names Dear Mr. Mazzullo of our clients in Cleveland that was sending specimen of fungus to our laboratory for identification. They used the Recently, an FAA agent by the name of Jim Berk here in Salt Lake City called me regarding a shipment from one technical name (Fungus). Mr. Berk felt that this designation was not sufficiently technical for use as the technical issue on occasion. In the past, I have trained classes of clients and others that if they do not know what the name. The client feels that they do not know any more about the specimen than that it is fungus. We have this organism is, they should enter the Gram Stain results, such as (Gram negative bacillus) or (Gram positive rods). I Sample). I discussed this with Mr. Berk. He then forwarded two pieces of information to me. One was a letter called the Hazmat Hotline, and I was told by Kurt that the client in this case should use the term (Fungus es of ratormation to me. One was letter signed by you dated May 8'h Virus Sample" is rot sufficient as a technical name. That leads me to wonder about the (Fungus Sample) , 2002, to Beth E. Henricson, Ref. # 02-0127. In that letter, you mention that the term designation. In addition, Mr. Berk told me that ICAO would not accept the (Fungus Sample) designation, anc since airlines follov/ IATA rules, a well informed airline cargo agent may refuse that shiprent as well I would like a clarif cation as to what an Infectious Substance Technical Name should be in the situations I have when they are sending it for identification. Thank you for your response. described, where the source hospital or clinic does not know to what Genus and species an organism belongs Paul H. Brinton, MT (ASCP) Vice President, Transportation & Logistics ARUP Laboratories 9/13/2004#

Page 4Infectious Substance Technical Names Page 2 of 2 500 Chipeta Way Salt Lake City, UT 84108 (801)584-5136 brintoph@aruplab.com attachments are from ARUP Laboratories and are intended only for the The information transmitted by this e-mail and any included and may constitute inside or non-public information under recipient. The information contained in this message is confidential international, federal, or state securities laws, or protected health information and is intended only for the use of the recipient. nauthorized forwarding, printing, copying, distributing, or use of such information is strictly prohibited and may be unlawful. If you are not the intended recipient, please promptly delete this e-mail Laboratories Compliance Hot Line in Salt Lake City, Utah USA at (+1 and notify the sender of the delivery error or you may call ARUP 9/13/2004#

Page 5Zad Response Edmonson, Eileen Kel. No. 04-0216 Sent: From: To: Thursday, November 04, 2004 9:12 AM §§171-8,172.101(c)(11), Subject: Cc: la susan form1102200 72016477172.2032 Gorsky, Susan; Mitchell, Hattie Technical Names PaulsLabels_Form.p df (225 KB) Eileen, Please handle. Thanks, Ed From: Brinton, Paul [mailto:brintoph@aruplab.com] •----Original Message-- To: Ed Mazzullo Sent: Wednesday, November 03, 2004 6:14 PM Subject: FW: Labels and (E-mail) Forms 11022004 mandated forms Mr. Mazzullo, I wanted to send this file to you to make sure that, if we use the IATA Law. Much of the verbiage has changed for the coming year. This will also change the and labels in the attached PDF file, we will not be in violation of Federal name. information we recently asked for regarding the use of the term "Fungus" as the technical date of March, 2005. We are in the process of creating ship specimens. Ne must have all information ready by the end of November, This User's Guide includes instructions for our clients on how to our scientific User's Guide, with a publication lot receive the "ATA regulations until late October, 2004. We are also updating our on- 2004. We did and a written response, line Infectious Substance training course. so that, if questioned, I might be able to send the your response I would like to request an immediate response, to satisfy the question. Thank you for your help. Vice President, Paul H. Brinton, MT (ASP) ARUP Laboratories Transportation & Logistics 500 Chipeta Way Salt Lake City, UT 84108 (801) 584-5136 brintoph@aruplab.com From: -----Original Message- Sent: Wednesday, November 03, 2004 15:48 say november 03, 2000 35.10 Subject: To: Brinton, Paul Labels and Forms 11022004 <<Paulslabels_Form.pdf>> Paul, here is the file you requested. 500 Chipeta Way Timothy Scot Millar - Problem Resolution Specialist ARUP Laboratories, Inc. Salt Lake City, Utah 84123 1-800-242-2787 ext. 2336 <<Paulslabels_Form.pdf>> The information transmitted by this e-mail and any included attachments are from ARUP 1#

Page 6Laboratories anc. are intended only for the recipient. The information contained in this international, federal, or state securities laws, or protected health information and is message is confidential and may constitute inside or non-public information under distributing, or use of such information is strictly prohibited and may be unlawful. If intended only fcr the use of the recipient. Unauthorized forwarding, printing, copying, sender of the delivery error or you may call ARUP Laboratories Compliance Hot Line in Salt you are not the intended recipient, please promptly delete this e-mail and notify the Lake City, Utah USA at (+1 (800) 522-2787 ext. 2100#

Page 7UN3373 SPECIMENS DIAGNOSTIC Salt Lake Cly, Ull 84108 Responsible person#

Page 8Dry Ice Note: 2 Ibs. = 1 kg. кg.* REFRIGERATION 800•242 • 2787 Salt Lake City, UT 84104 500 Chipeta Way ARIP SPECIMENS OF MEDICAL UN 1845 FOR THE#

Page 9SHIPPER'S DECLARATION FOR DANGEROUS GOODS Stripper Air Waybil No. Page 1 1 Pages Shipper's Reference Number: (optional) Consignee: 600 Chipeta Way Associated Regional and Univorsity Pathologists, Inc. Salt Lake City, Utah 84108 ARIP faul Brinton (801) 583-2787 ext. 5136 to the operator. Two completed and signed copies of this Declaration must be handed WARNING TRANSPORT DETAILS Failure to comply in all respects with the applicable limitations prescribed for: This shipinent is within the Airport of Departure applicable law, subject to legal penalties. Dangerous Goods Regulations may be in breach of the (delete run-applicable) PASSENGER AND CARGO AIRCRAFT Airport of Destinatin: Salt Lake City, Utah NON-RADIOACTIVE XXXXXXXXX Shipment type: (delete non-applicable) NATURE AND QUANTITY OF DANGEROUS GOODS (see sub-Section 8.1 of lATA Dangerous Goods Regulations) Dangerous Goods Identification UN ID or No. Proper Shipping Name Division Class or Pack- Group ing type of packing Quantity and Packing Inst. Authorization WN 2814 Infectious substance, 6.2 (Suspected Category A affecting humans _mL 602 Infectious Substance) Arklitional Handling Information described above by the proper shipping name, and are ciassilied, packaged. 1 hereby desiare that the contents of this consignment are fully and accurately Name/Title of Signatory transport acéording lo ile applicable International and National Government marked and labeled placarded, and are in all respects in proper condition for ave been net. Ragdations ¡ decture the ed of the applicable air transport requirements Place and Date (sce waning abo) Signature#