ARUP Laboratories — Hazardous Materials Safety Interpretation

Page 1of Transportation U.S. Department 400 Seventh St., S.W. Research and Washington, D.C. 20590 Special Programs Administration AUG 1 1 2003 Mr. Paul H. Brinton Ref. No. 03-0161 Assistant Vice President, Transportation and Logistics ARUP Laboratories 00 Chipeta Way Salt Lake City, Utah 8410 Dear Mr. Brinton: This responds to your email of July 2, 2003, concerning the applicability the Hazardous Materials Regulations (HMR; 49 CFR Parts 171-180) to the transportation of infectious substances. Specifically, you ask about shipping paper and package labeling requirements for a shipment containing multiple pathogens. According to your email, you ship specimens in containers that are placed inside plastic bags and then placed within pressure vessels. Each specimen container may contain a different pathogen. Several pressure vessels are then placed with temperature media inside a secondary packaging that consists of a layer of fiberboard, a layer of urethane, and an additional layer of fiberboard that is coated with waterproofing. The secondary packagings are then placed within an outside packaging. You provide an example of a shipping paper for a single package that contains three 5-ml tubes of Hepatitis C and one 5-ml tube of Human immunodeficiency virus packed with 2.2 kg of dry ice. You ask how the different hazardous materials contained in the package should be listed on the shipping paper. Your shipping paper entry for the infectious substances packed with dry ice should read as follows: Proper Shipping Name UN or It Packing Group Subsidiary Risk Quantity and type of packaging affecting humans (Hepatitis Infectious substance, 6.2 UN 2814 20 ml immunodeficiency virus) C, Human AND Carbon dioxide, solid UN 1845 Ill 2.2kg Packed in 1 plastic box 173.196173199 030161#

Page 2As an alternative, you may elect to list each pathogen separately. In that case, your shipping paper entry should read as follows: Proper Stripping Name Class or Division UN or ID No. Packing Group Subsidiary Risk Quantity and type of packaging affecting humans (Hopatitis Infectious substance, 6.2 UN 2814 15 ml c) AND affecting humans (Human Infectious substance, 6.2 UN 2814 5 ml immunodeficiency virus) AND Carbon dioxide, solid UN 1845 22kg Packed in 1 plastic box With your email, your provided a copy of the label that you propose to utilize to meet the package be marked with the technical name of the hazardous material in parentheses in association with the marking requirements of § 172.301 of the HMR. Paragraph (b) of § 172.301 requires a package to proper shipping name. On the label you provided, the technical names of the material are not listed in parentheses in association with the proper shipping name. To conform with § 172.301(b), the package must be marked "Infectious substance, affecting humans (Hepatitis C, Human immunodeficiency virus)". I hope this information is helpful. If you have further questions, please do not hesitate to contact this office. Sincerely, Edward T. Mazzullo Director, Office of Hazardous Materials Standards ...........#

Page 3Gorsku Gorsky, Susan € /13/14 Sent: From: Brinton, Paul [brintoph@arupiab.com] Subject: To: Wednesday, July 02, 2003 12:09 PM $173.199 Gorsky, Susan Infectious Substance RE: DOT Infectious Substance/Diagnostic Specimen Transport Regulations 03-0161 Open Pressure Vessel with tube... Box with inner sections.jpg Box with opened refrigerated s... DGD Form_filled out.jpg Box roady for shipping.jpg Open Pressure Vessel.jpg Proper Shipping Name outer, and then Our packaging generally consists of a corrugated plastic three possible configurations of inner containers, one for each temperature of specimen being shipped. fiberboard, a one inch layer of urethane, The inner containers an additional layer of fiberboard, consist of a layer of and that layer is coated with a waterproofing coating. medium, either cold gel packs, or dry ice is interspersed with the pressure The temperature vessels inside the inner container. containers, inside plastic bags and then inside the pressure vessels. The specimens are generally in specimen certification markings are on the plastic outer layer. from the outer plastic jacket was certified as a pack the entire package was certified as a whole, the package is not considered an over I am including some pictures of our process. II not, I would be happy to print them and send them to you. I hope you can receive questions, please call or contact me. brief explanations as to what they show. In addition, I would like to request If you have labeling of the shipping container with the names of the organisms. an official letter supporting our position on the format of the DGD and the may be able to give us. that label the Proper Shipping Name (PSN) label. Thank you for any help you Paul H. Brinton, MT (ASP) President, Transportation & Logistics 500 Chipeta Way Salt Lake City, UT 84108 brintonph@aruplab.com <mailto:brintonph@aruplab.com> (801) 584-5136 -----Original Message----- Sent: Monday, June Susan [mailto:Susan.Gorsky@rspa.dot.gov] 'brintoph@aruplab.com' Regulations RE: DOT Infectious Substance/Diagnostic Specimen Transport Paul, I have consulted with several of my colleagues in the Hazmat Standards multiple organisms in one The answer to your question depends on how you package your box, then you may list "Infectious substance, affecting humans" once on the If by one shipment you mean a single shipping paper and list the different organisms in parentheses after the boxes, then you must separately list the contents of each box on the However, if your one shipment consists of several different shipping paper (thus, if five boxes, then five separate entries for "Infectious substance, affecting humans" followed by the technical name of#

Page 4the specific organism after each entry). I hope this is helpful. Susan From: Brinton, Paul [mailto:brintoph@aruplab.com] •----Original Message----- To: Gorsky, Susan Sent: Wednesday, June 18, 2003 3:44 Regulations Subject: RE: DOT Infectious Substance/Diagnostic Specimen Transport Susan, I am wrestling with an issue as to how a Dangerous Goods Declaration It has been our procedure to list 1 Son or procedure es is enforcise botan ame in Longe so Char forat, and and apcat he Treet o3 anement for dan that, placed inside parentheses. the opportunity for errors and extra forms to no good purpose. This seems overly complex to us, me information to help alleviate this situation, or direct me to someone Can you give that may be able to help ? Thank you very much. Paul H. Brinton, MI (ASCP) ARUP Laboratories Assistant Vice President, Transportation & Logistics Salt Lake City, UT 84108 500 Chipeta Way brintonph@aruplab.com<mailto:brintonph@aruplab.com> (801) 584-5136 «<Box with opened refrigerated section. ipg>› Vessel with tubes. jpg>> «<DGD Form_filled out. jpg»> with inner sections. jpg>> Vessels wth gel packs.jpg>> shipping. jpg>> «Proper Shipping Name Label. ipq>> «Open Pressure Vessel.jpg>> «Pressure#