Interpretation Response #14-0060 ([Safe-T- Pak, Inc.] [Mr. David Creighton])
Below is the interpretation response detail and a list of regulations sections applicable to this response.
Interpretation Response Details
Response Publish Date:
Company Name: Safe-T- Pak, Inc.
Individual Name: Mr. David Creighton
Country: CA
View the Interpretation Document
Response text:
August 27, 20014
Mr. David Creighton
Regulatory and Training Manager
Saf-T-Pak, Inc.
17827-111 Ave
Edmonton, AB T5S 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?
A1. 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)?
A2. 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,
T. Glenn Foster
Chief, Regulatory Review and Reinvention Branch
Standards and Rulemaking Division
173.199, 178.609, 173.134(b), 173.24, 173.24a, 173.199(a)(4), 173.199(a)(10), 178.2(c)(1)(ii)(B)