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

Page 1of Transportation U.S. Department Washington, D.C. 20590 1200 New Jersey Avenue, SE Materials Safety Pipeline and Hazardous Administration AUG 2 7 2014 Mr. David Creighton Regulatory and Training Manager Saf-T-Pak, Inc. 17827-111 Ave Edmonton, AB TSS 2X3 CANADA Reference No. 14-0060 Dear Mr. Creighton: This is in response to your March 26, 2014 e-mail requesting clarification of the packaging requirements for "UN 3373, Biological substance, Category B, 6.2 (infectious substance)" under the Hazardous Materials Regulations (HMR; 49 CFR Parts 171-180). Specifically, you ask several questions concerning how these requirements would apply if the packaging is composed of components from sources that are different than those of the original tested packaging. We have paraphrased your questions and answered them in the order provided. Q1. Is it possible to alter, add, remove, or mix packaging components of a Category B packaging from its tested design without performing a new drop test? Al. The answer is yes. As specified in § 173.199, a Category B packaging must be capable of successfully passing the drop tests prescribed in paragraph (d) of § 178.609 at a drop height of at least 1.2 meters (3.9 feet) but is not required to be tested using this method. Capability may be demonstrated using a number of methods, including actual previous handling and transportation experience, design specification, or, even though not required, performance testing. Category B packagings authorized under exceptions prescribed in § 173.134(b) are also not required to be drop tested. However, depending on the type of exception used, such packagings must meet one or more of the following: the general packaging requirements prescribed in §§ 173.24 and 173.24a, the packaging provisions of § 173.199, and/or the Department of Labor's Occupational Safety and Health Administration bloodborne pathogen requirements prescribed in 29 CFR 1910.1030. Q2. If a shipper alters the components of a packaging that has met a tested design, is the shipper responsible for ensuring that the altered packaging is capable of passing the drop test prescribed in § 173.199(a)(4)?#

Page 2A2. The answer is yes. Although performance testing is not required for a packaging meeting the requirements of § 173.199, the responsibility remains in effect under the HMR for the person who authorizes that the packaging is in compliance with that standard to demonstrate it is capable of meeting a 1.2 meter drop test. Q3. Is the shipper responsible for creating new closure instructions as prescribed in § 173.199(a)(10) for packagings with components that have been added, removed, or mixed? A3. The answer is no. The HMR requires packaging closure instructions for DOT specification and UN standard packagings that comply with the requirements in 49 CFR Part 178 (see § 178.2(c)(1)(ii)(B)). The HMR does not require closure instructions for packagings that comply with § 173.199. I hope this satisfies your request. Sincerely, Istern rosta T. Glenn Foster Chief, Regulatory Review and Reinvention Branch Standards and Rulemaking Division 2#

Page 3Edmonson §143.199 Edmonson, Eileen (PHMSA) Caregory B Infectious Substances From: David Creighton <DavidCreighton@saftpak.com> 14-0060 Sent: Wednesday, March 26, 2014 3:13 PM To: Edmonson, Eileen (PHMSA) Subject: Letter of Interpretation Hello Eileen I wanted to add my appreciation for your attendance and assistance at the ABSA shipping discussion earlier this month. There was an item from the meeting that I wanted to discuss with you. In the packaging section the question was raised about mixing and matching components of Category B packages from different manufacturers, or adding or removing components that are not part of the approved package design as outlined in the closure instructions. As a packaging manufacturer, we have come across a number of shippers who do not understand the importance of following the closure instructions, especially in relation to drop test requirement. As such I was wondering if it is possible to receive a PHMSA letter of interpretation on the following questions. Is it possible to alter (mix for different manufacturers, add or remove) components of a Category B package from its tested design without performing a new drop test? If the shipper alters the components from the package design, is the shipper responsible to ensure the altered package design is capable of passing the drop test as outlined in 173.199 (a) (4) and is the shipper responsible to create new closure instructions as outlined in 173.199 (a) (10)? Thank you David Creighton Regulatory and Training a rating 25 las Manager 1988-2013 Saf-T-Pak Inc. Phone: 780-733-7702 SAFTPAR Fax: 780-486-0235 A Cantel Medical Company www.saftpak.com or Quality Serie Celebrating 25 years of Trust, Respect & Quality Follow us using This communication (including any attachments) is intended only for use by the addressee(s) named herein and may contain legally privileged or confidential information. If the reader of the message is not the intended recipient or an authorized representative of the intended recipient, you are hereby notified that any dissemination or distribution of this communication (or attachments) is strictly prohibited. If you have received this communication in error, please notify us immediately by e-mail and permanently delete the communication and any attachments from your system.#