William Wilkening — Hazardous Materials Safety Interpretation

Page 1• Memorandum US Deportment of Transportation Research and Administration Special Programs Dato JUN 12 2001 Redly to Aren of Ref. No. 01-0038 Subject INFORMATION: Dry Shipper Instructions from Chart Industries Alo From Office of Hazardous Materials Standards, DHM-10 William Wilkening, Program Manager Dangerous Goods/Cargo Security, ACO-800 This responds to your memorandum dated February 2, 2001, requesting clarification of the applicability of the Hazardous Materials Regulations (HMR; 49 CFR Parts 171-180) to the use of a "dry shipper." A "dry shipper" is a dewar flask that has an outer jacket and an inner containment vessel. The absorbent material, saturated with liquid nitrogen, is located between the inner and outer walls in order to serve as a refrigerated container for the shipment of biological materials. If there is no free liquid present in the packaging, the liquid nitrogen does not exhibit the characteristics of a "cryogenic liquid" as defined in 49 CFR 173.115(g) and does not pose a hazard in transportation. Therefore, a "dry shipper" with no free liquid present in the packaging, regardless of the orientation of the packaging, is not subject to regulation under either the HMR or the International Civil Aviation Organization (ICAO) Technical Instructions for the Safe Transport of Hazardous Materials. However, if the packaging is offered for transportation with free liquid present, it is subject to regulation when offered for transportation by aircraft (see 49 CFR 173.320). I hope this answers your inquiry. If you need further assistance, please do not hesitate to contact us. ##

Page 2Boothe $173.320 Memorandum U.S. Department of Transportation Exceptions Federal Avlation Administration 01 - 0038 Subject: ACTION: Dry shipper instructions from Chart Dato: Industries FEB 22001 From: Program Manager, Dangerous Goods/Cargo Reply t Security, ACO-800 ston. of To: Robert McGuire, Associate Administrator for Hazardous Materials Safety, DHM-1 Our Western Pacific region has opened a case against the University of Arizona Medical School for offering an improperly packaged cryogenic liquid in air transportation. The university failed to drain excess nitrogen from a "dry shipper" container, and the package leaked at a Federal Express facility. In response to our Letter of Investigation, the university provided the attached letter from the Applied Technologies Division of Chart Industries, dated August 16, 2000. We request your opinion as to whether the information provided in this letter is valid, and section 173.320(a)(3)(ii) is in effect. If the letter cannot be verified, we will continue to 16282) move against the shipper. We are interested in sending an agent from our Minneapolis field office to inspect this company, which is located in Bumsville, Minnesota. We invite participation by your Central Region inspectors on this inspection to clarify the regulations. We appreciate any support you can provide on this matter. William Wilkening Attachment cc: Debra Straus, AGC-300 JUN 1 9 2001 JUN 1 1 2001 ' 12 2001 JUN 12 2001 JUN 12 2001#

Page 3- TART ippled Technologies Divistor nart laduseries, ine 3309 Courry Road 42 Wer Tel 612.892.5000 Fox 612.0923193 suramik, MN 33305-3803 USA ww.neesc.com August 16,2000 Attention: This confirms our relephone conversation concerning the applicability of the Federal Hazardous Material Regulations to the shipment of refrigerated samples in your "dry shipper" container. A "Dry Shipper'" package consists of an oures container tbat is lined with an absorbent material. The container is charged with nitrogen refrigerated liquid which is absorbed into the container lining. The charged, completo package serves as a refrigerated container for the shipruent of biological materials. In consideration of the above, consultation with the Matenal Iraasportation Buresu of the Research and Special Programs Administration has determined that the use of nitrogen refrigerated liquid charged "dry shipper" containers for the sbipment of biological materials falls within the regulation exception provided in 49CFR173.320. Paragraph (a)(3X(III) of that section stares the requirements of this subchapter (subchapier C-the Hazardous Maichal Regulations) do not apply to atmospheric gases and helium when used in the operation of a process system; such as & rein geration sysiem. (622) I sincerely, - i Lois Tuma Inside Sales : Biological Products SEES 'ON 8805 288 256 6S:ST 18/92/10 200d 168'ON 981549228216 ts 2-dny 28:88 18/92/88#

Page 4_ FEB. 7.2001. 3:01PM CIVIL AVIATION SECURITY NO.253 P.113 .... : Federal Aviation Administration Civil Aviation Security Dangerous Goods Advisory Bulletin - Information of Concern to Air Carriers Subject: Liquid Nitrogen In Dewars : Number: DGAB-98-03 Date: AUG 25 1998 : INFORMATION: The Federal Aviation Administration (FAA) is issuing this Advisory Bulletin to alert air carriers to the hazards associated with mishandling authorized packagings utilizing liquid nitrogen as a refrigerant. These packagings are "non-pressurized" flasks and specially designed flasks known as "dry shippers", which are used to transport refrigerated biological specimens. Liquid nitrogen is a regulated material subject to 49 CFR Parts 100 - 180, Hazardous Materials Regulations, (see 173.320(c)) and the Interational Civil Aviation Organization's Technical Instructions for the Safe Transport of Dangerous Goods by Air (see Packing Instructions 202). Safe Handling: The closure of the container is designed to allow venting to the atmosphere, through the fill opening, in order to prevent the build up of pressure within the package. Packages are designed to be transported in an "upright" position at all times. These containers release of liquid nitrogen through the venting system when handled adversely to the orientation markings and package design. Therefore, it is important that personnel that handle, load and unload flasks that contain liquid nitrogen maintain the flask in the upright position at all times. Failure to do so may result in the release of liquid nitrogen and cause injury. • instructions in 202. Non-pressurized flasks are similar in design and appearance to "dry shippers", except they are filled with liquid nitrogen, and the biological specimens are suspended in it. OPTIONAL FORM 19 (7-80) FAX TRANSMITTAL 3 • Jaln Gale Tron Blomo Prone 73207 Fax 8 NSN 7540-01-317-7744 43012 5080-101 GENERA GEAVICES ADMINSTRATION.#

Page 5FEB. 7.2001 3:01PM CIVIL AVIATION SECURITY NO.253 P. 2/3 • Dry Shippers: Instructions 202) are not subject to the requirements of the regulations. However, Dry shippers, when property prepared see the Note at the end of Packing if the dry shippers are offered with free liquid nitrogen present, they would be subject to the regulations when offered for transportation by aircraft (see 49 CFR 173.320) and must be offered in accordance with the ICAO Technical Instructions. These packagings use liquid nitrogen (Division 2.2, cryogenic liquid) as a refrigerant. A dry shipper consists of an outer metal jacket and an inner shell, with the space between filled with insulation and vacuum-sealed. The interior of the packaging contains a cylindrical void, which holds the material requiring refrigeration, surrounded by absorbent material. The absorbent material is saturated with the liquid nitrogen. The FAA has found shipments where the nitrogen is not completely absorbed so when handled adverse to the orientation markings, results in a loss of liquid nitrogen. FAA Enforcement: The FAA, will actively pursue enforcement actions against all partles who violate the Hazardous Materials Regulations or the ICAO Technical Instructions. Violators are subject to civil penalties of $27,500 and criminal prosecution with penalties: of $250,000 and up to five years in prison. Bruce Butterworth Director, Office of Civil Aviation Security Operations#

Page 6FEB. 7.2001 3:02PM CIVIL AVIATION SECURITY No.253 P.3/3 ! \MVE MVE, Inc. 3S0S Country Road 42 West i 8-800-100-683 Bumsville, MN 55006 F.612-682-5172 ! FILLING INSTRUCTIONS FOR MVE VAPOR SHIPPERS : MATERIALS, COMPATIBLE WITH THE DIVERGENT TEMPERATURE EXTREMES AND BROAD THESE HIGH QUALITY VACUUM INSULATED UNITS ARE CONSTRUCTED OF DURABLE APPLICATIONS OF CRYOBIOLOCY. THE ABSORBENT MATERIAL USED IN CONSTRUCTION AFTER 1993 IS HYDROPHOBIC (WILL NOT ABSORB WATER) WHICH UNLIKE CALCIUM SILICATE DOES NOT NEED TO BE PERIODICALLY HEATED TO REMOVE ABSORBED MOISTURE. THE MVE VAPOR SHIPPERS WERE PRIMARILY DESIGNED AS VAPOR SHIPPING CONTAINERS; HOWEYER, THEY CAN ALSO BE USED FOR IMMERSION OF SAMPLES. WHEN USING UNIT TO THE TIP AND ALLOW THE LIQUID NITROGEN TO ABSORB. UPON COMPLETE ABSORPTION IN EITHER CONDITION. THE RECOMMENDED FILLING PROCEDURE IS AS FOLLOWS: FILL THE ANOTHER FILL, REPEAT AGAIN IF NECESSARY. COMPLETE ABSORPTION MAY TAKE UP TO 2 OF THE FIRST FILL OF LNZ. WHICH SHOULD TAKE A MINIMUM OF & HOURS, REPEAT WITH LIQUID IF THEY ARE INTENDED TO BE USED AS A VAPOR (DRY, SHIPMENT. HOURS. AFTER COMPLETING THE LAST FILL. JUST PRIOR TO SHIPMENT, POUR OFF THE EXCESS LIQUID, IT IS ADVISABLE TO WEIGH THEM. TO COMPLETELY FILL THE ABSORBENT. THE TO INSURE THAT THE VAPOR SHIPPERS HAVE ABSORBED THEIR FULL CAPACITY OF SUGGESTED ABSORDED WEIGHT OF THE UNITS IS A LISTED BELOW SHOULD BE REACHED. THIS WILL ALLOW THE CONTAINERS TO HOLD THE MAXIMUM NUMBER OF DAYS IN THE VAPOR SPECIFICATIONS I*1/ hey leafle 8.8 8 SCARY 11 IS 14 20.6 SC20/12v 53 XCZ0/3Y 23 38 24 39 25 XC142v 25 CRYOSHIPPER 26 37.3 10 30 14 MINI MOOVER CRYOSHIPPER * CBP. 8.J 11.6 14 CRYO-MOOVER 30K 33 12 8 11.63 ARCTIC I S 6 2.8 LNZ NEEDED TO FILL THE ABSORBENT WILL BE GREATER. THE TIME NEEDED FOR THIS FILLING DURING THE INITIAL FILL OR AFTER THE UNIT IS ALLOWED TO WARM. THE AMOUNT OF PROCEDURE WILL ALSO BE GREATER. 8/2 8 56E8 ON 100% 90 M 8205 28025 Ter92/10#