Saf-T-Pak, Inc. — Hazardous Materials Safety Interpretation

Page 1U.S. Department of Transportation 100 Seventh Street, S.W. Vashington, D.C. 2059( AFP 2 2 1998 Mr. Eric Cook Sat-I-Pak, Inc. Ref. No. 98-0131 101, 17872-106 Avenue Edmonton, Alberta CANADA T5S 1V4 Dear Mr. Cook: This is in response to your letter dated June 2, 1998, regarding the marking requirements for infectious substance packagings manufactured in the United States. Your questions have been paraphrased and answered as follows. Q1. Is it correct that a UN specification mark is not required on packaging manufactured or used in the United States for infectious substances? A1. Yes. the Infectious substance packagings manufactured in United States are not required to have package specification markings under the Hazardous Materials Regulations (HMR; 49 CFR Part 171-180). As you state in your letter, § 178.609 (i) meet the test requirements in that section from the excepts packagings that requirements of Subpart N of Part 178, except for Infectious substance packages transported in the United States by aircraft under § 171.11, or by vessel under 171.12, must be marked with the appropriate UN specification mark. International markings for such packagings, including the markings required under the International Civil Aviation Organizations Technical Instructions for the Transport of Dangerous Goods by Air (ICAO Technical Instructions) and the International Maritime Dangerous Goods Code (IMDG Code), are acceptable to the DOT provided test records show that the test requirements of § 178.609 have been met. Q2. If a hazardous materials packaging manufacturer in the United States were to put a UN specification mark on an infectious substance packaging manufactured in the United States, what would this marking designate?#

Page 2A2. If the mark is as prescribed in the ICAO Technical Instructions or the IMDG Code, the mark designates that the packaging conforms to the UN specification packaging criteria contained in those regulations. Also, enclosed is a recently published advance notice requirements. of proposed rulemaking concerning infectious substance I hope this satisfies your request. Sincerely, Hattie I. Mitchell, Chief Regulatory Review and Reinvention Office of Hazardous Materials Standards Enclosure 2#

Page 330ch SAFA PAK® 19XX Annisceras 190% SAF PAK INC. June 2, 1998 mack Ed Mazzullo US Department of Transportation File 173,196 Research and Special Programs Administration Office of Hazardous Materials Standards 400 Seventh Street, S.W., Washington, D.C. 20590 Dear Mr. Mazzullo: goods. Currently we are preparing to set up a manufacturing facility in the US and plan to have a Saf-T-Pak, Inc. manufactures UN Specification packaging for transporting Class 6.2 dangerous US facility test our packaging. I wish to inquire about US requirements for specification markings on packaging for Class 6.2 dangerous goods manufactured and used in the US. My question is in 1.1 am aware of UN and ICAO requirements for specification marking however, is it correct the US for Class 6.2 Dangerous Goods? that a UN specification mark is not required on packaging manufactured and or used in 49 CFR 173.196 outlines the components of authorized packagings and indicates that each packagings subject to this section are not subject to the specification marking requirements of package must be capable of passing the tests specified in 178.609. 178.609(i) stipulates that 178.503. As long as a package met all the requirements in 173.196 and was capable of passing the tests in 178.609, would it require the UN specification mark in order to transport infectious substances legally in the US? 2. If a US manufacturer were to put a UN specification mark on such packaging what would it designate? standard is set forth in the HMR and the other in which a UN standard is not set forth. Is the UN 178.3(b) outlines two options for marking of UN standard packagings: one in which the UN standard set forth in 178.609 or would a manufacturer be required to establish that the packaging packaging for infectious substances manufactured in the US, indicate conformance to 178.609 or contorms to the applicable ICAO standards? In other words, does the UN specification mark, on conformance to the ICAO standards set out in Packing Instruction 602 and Part 7 Chapter 6 of Thank you for taking the time to respond at your earliest convenience so that we may plan our production strategy. Please call me at 1-800-814-7484 if any further clarification is needed. Sincerely, Eau look Biological Technical Specialist Eric Cook Saf-T-Pak, Inc. 101, 17872 - 106 Avenue Edmonton, Alberta Canada T5S 1V4 • (403) 486-0211 Fax: (403) 486-0235 (800) 814-7484 E-Mail: 75357.1226@compuserve.com Website: www.saftpak.com#

Page 4NAST $ 1999 SAF I PAK Edward Mazzul1o Suite 101 17872 106 arenue US Department of Transportation Research and Special Programs Admin. Edmonton. Alberta Conada Office of Hazardous Materials Standards. TSS 1Y4 400 Seventh Street, s.w., washington, D.C. 20590#