First Filtration International Co., Ltd. — Hazardous Materials Safety Interpretation

Page 1FEB 1 3 2003 of Transportation U.S. Department 400 Seventh St., S.W. Special Programs Research and Washington, D.C. 20590 Administration Mr. Alastair Hayton-Williams Sales and Marketing Consultant Reference No. 02-0264 37/2 Moo 9, Sukhumvit Road First Filtration International Co., Ltd. Banglamung, Chonburi 20260 Thailand Dear Mr. Hayton-Williams: This is in response to your letters and additional information concerning your product, the Aqui- Pak pouch. You described the product as being made of a multi-layered, absorbent, disposable polymeric material. You state that the pouch provides separation, absorption and cushioning in one product and can be used as the secondary packaging for liquid primary receptacles. You also state that a liquid upon contact with the polymeric material is completely absorbed and becomes inconvenience this may have caused. a gel. We have paraphrased your questions. We apologize for the delay in responding and any Q1. Must our Aqui-Pak pouch be tested by the Research and Special Programs agnostic specimen under the Hazardous Materials Regulations (HMR; 49 CFR Part dministration (RSPA) or other company to be approved as a packaging component for 171-180)? Al. The answer is no. The secondary packaging is not required to be tested as an individual component but as part of the complete packaging. RSPA does not test or certify hazardous materials packagings. In a recently published final rule, we adopted new § 173.199 to the HMR to permit a diagnostic specimen other than Risk Group 4 to be transported in a non-DOT and an outer packaging (Docket No. RSPA-98-3971 (HM-226), August 14, 2002, copy specification triple packaging consisting of a primary receptacle, a secondary packaging, enclosed). This section requires that the primary receptacle and the secondary packaging be properly packed and secured and that the secondary packaging be leakproof. The completed packaging must also be capable of passing a 1.2 meter (3.9 feet) drop test as prescribed in § 178.603. If intended for the transport of liquids by aircraft, § 173.199(b)(4) requires that the primary receptacle or secondary packaging be capable of withstanding, without leakage, an internal pressure producing a pressure differential of not less than 95 kPa (0.95 bar, 14 psi). It is the shipper's responsibility to ensure that the packaging or container is an authorized packaging and meets all applicable requirements. 173.199 020264#

Page 2A Risk Group 4 diagnostic specimen must be classed and transported as a UN 2814 or UN 2900 infectious substance in a packaging tested and marked as required by § 173.196 and § 178.503(f), respectively. See §173.134(a)(4). The new requirements become effective February 14, 2003; however, voluntary compliance is authorized. Q2. Our Aqui-Pak pouch conforms to Packing Instruction 650 of the International Civil Aviation Organization's Technical Instructions for the Transport of Dangerous Goods by A2. If, as you state, the combination packaging containing the Aqui-Pak pouch conforms to the completed secondary packaging must meet all applicable requirements. Packing Instruction 650 of the ICAO Technical Instructions, the answer is 10. However, I hope this satisfies your request. Sincerely, White 2. Mitshelf Hattie L. Mitchell, Chief Regulatory Review and Reinvention Office of Hazardous Materials Regulation Enclosures#

Page 3Page 1 of 2 INFOCNTR From: Alastair [eightwestfour@hotmail.com] Sent: Wednesday, October 02, 2002 1:39 AM To: Infocntr, Infocntr <RSPA> Edmonson Subject: Fw: OHMS\Aqui-Pak -§/73.34199 Redugnoshe Specumen = sorry! Last letter sent without attachments. Mr. Edward T. Mazzullo 02-0264 Ms. Susan gorsky Office of Hazardous Materials Standards U.S. DOT/RSPA (DHM-10) 400 7th Street S.W. Washington, D.C. 20590-0001 Dear Mr. Mazzullo and Ms. Gorsky, Transportation of Diagnostic Medical Specimens We are writing to you as we would greatly appreciate your advice and assistance concerning a material used for transporting hazardous liquids, serum and medical specimens. You can see on our web-site the most recent article concerning Safebox and the Royal Mail (Great 3ritain). We manufacture the insert for Safebox - Aqui-Pak. Aqui-Pak is a super-absorbent including blood and urine. This concept is of immense interest to those concerned with safety disposable material for the sate transportation of hazardous liquids and diagnostic specimens, involved in taking and transporting samples. You can also see the magazine in which our in the courier and mailing companies, medical and veterinary professions and to anyone press release was published and photographs of both Aqui-Pak and Safebox on our Web- site. There is strong interest in this product from companies in USA, and we would very much like to know if our material has to be tested by you, or whether it is tested in conjunction with the outer packaging supplied by the client company. The material was developed following requests from couriers and the postal service in Great stations although there are many other applications and uses. No doubt you may have other Britain for use by hospitals; laboratories, drug and alcohol testers, veterinarians and police ideas. The pouch form costs only a few US cents. The directive P650 is also on our web-site, which relates to UN 3373 concerning packaging specifications, particularly by allowing the four samples to be places alongside each other yet materials used in the transportation of diagnostic specimens. Aqui-Pak conforms to these separated in the totally absorbent pouch. As such, do we need to take any further steps? 10/2/02#

Page 4Page 2 of 2 Our new web address is www.firstfiltration.com Thank you for your assistance. Yours sincerely Alastair Hayton-Williams Sales and Marketing Consultant First Filtration International Co. Ltd. 10/2/02#