Saf-T-Pak — Hazardous Materials Safety Interpretation

Page 1U.S. Department of Transportation MAR 9 2007 Washington, D.C. 20590 400 Seventh Street, S.W. Pipeline and Hazardous Materials Safety Administration Gail Ryckis-Kite Reference No. 07-0018 Development and Quality Manager Saf-T-Pak 17854 - 106A Avenue Edmonton, AB Canada T5S 1V3 Dear Ms. Ryckis-Kite: This is in response to your January 24 and 25, 2007 e-mails to this agency concerning a final rule we issued under Docket No. PHMSA-2004-16895 (HM-226A) (6/2/06, 71 FR 32244) to revise the requirements for transporting Division 6.2 (infectious substance) materials under requirements. You note that on page 32247, Column 1, paragraph 1, of the final rule we state the Hazardous Materials Regulations (HMR; 49 CFR Parts 171-180) with international a Category B infectious substance packaging must be capable of passing a drop test, but not a to be capable of passing at a height of 1.2 meters (3.9 feet) the drop and steel rod impact tests puncture or other performance test; however, under § 173.199(a)(4) we require this packaging prescribed in §178.609(d) and (h), respectively. You ask if the regulatory text requiring the steel rod impact test for this packaging is an error. The answer is yes. A packaging used to transport a Category B infectious substance must be capable of passing the drop test prescribed in § 178.609(d). The packaging is not required to in a future rulemaking. also be capable of passing the steel rod impact test in § 178.609(h). We will correct this error I hope this information is helpful. Sincerely, Hattie L. Mitchell, Chief Regulatory Review and Reinvention Office of Hazardous Materials Standards 173. (a)4) 070018 178.409 (h)#

Page 2Edmonson $173.199 3178.609 (h) From: Gail Ryckis-Kite [mailto:GailRyckisKite@saf-t-pak.com] Infections. Subtances To: Edmonson, Eileen <PHMSA> Sent: Thursday, January 25, 2007 5:24 PM Packaging 07-0018 Subject: RE: Questions/Concerns regarding CFR173.199 Category B Packaging Requirements Hi Elleen forward to seeing the correction. In the interim, our company still has a probiem that Thank you vary much for your reply. We can appreciate how this may happen and look maybe you can help me with, or direct me to ancther authority. This test came to our attention by the US DOT Office of Hazardous Materials Enforcement. commercially (Report Number 05435035 Supplemental). We would like to provide that This specific test was requested to be performed on a small shippor that we privide office with an appropriate response that invalidates the requirement of this specific test. to comply to ail regulations. in reaching compliance we have had to inform our customers in addition, as a supplier of compliance training and packaging material, we do our utmost of the regulatory text and the changes required to meet the standard. We wou d ask that we may provide both to the DOT testing authority and our customers showing that this the US Dopartment of Transportation provide us with some sort of formal response that 178.600(h). was indeed inadvertently text and compliance is not required to the steel rod impact test in Thank you again for your assistance in this matter. Gail Ryckis-Kite GaiRyckisKite@sattpak.com Development and Quality Manager www.sai-t-pak.com 1-800-814-7484 This communication (including any attachments) is intended only for use by the addressee(s) named herein and may contain alacements) is strictly prohible. If you have receivedy his communication in ror, please nily us immediately by ermain nor legally privileged or confidential information. If the reader of the message is not the intended recipient or an authorized permanently delete the communication and any attachments from your system From: Gail Ryckis-Kite [mailto:GailRyckisKite@saf-t-pak.com] Sent: Wednesday, January 24, 2007 5:49 PM To: Edmonson, Eileen <PHMSA> Subject: Questions/Concerns regarding CFR173.199 Category B Packaging Requirements Dear Ms. Edmonson, I am the Development and Quality Manager at Saf-T-Pak in Edmonton Alberta Canada. This regarding a change in the package testing requirements for Category B infectious substances company is a certified packaging and compliance training supplier and I have some questions (49CFR173.199). In particular, the addition of a puncture test specified in 49CFR178.609(h). Upon review of the Federal Register Vol. 71 No. 106 Friday June 2, 2006 | understand that the PHMSA proposed to harmonize with other requirements applicable to the transportation of Division 6.2 materials and adopt packaging requirements for Category A and Category B#

Page 3Instructions. infectious substances consistent with those in the UN Recommendations and ICAO Technical capable of passing a drop test, but need not be capable of passing a puncture or other In the preamble to the Section by Section review it reads that Category B packagings must be erformance test (p. 32247), However, the amended 49CFR173.199 section specifically state: Recommendations and ICAO Technical Instructions do not place this requirement onto the hat a puncture test (referenced only as 178.609(h)) must be successfully passed. Both the Ur Category B infectious substances packaging. discuss any recommendations and insight you might provide to us regarding international shipments in and out of the USA This material may demand a bit of your time for review thus I submitted this email first. Unless ote report 1202-36 or or you prefer may be c acted bye ma or he number sted one below - at your convenience. I look forward to discussing this material with you and receiving a bit more clarification. Kindest Regards, Gail Ryckis-Kite GailRyckisKiteKosaftpak.com Development and Quality Manager www.sai-t-pak.com 1-800-814-7484 gally privileged or confidential information. If the reader of the message is not the intended recipient or an authc rize is communication (including any attachments) is intended only for use by the addressee(s) named herein and inay conta alasment is the ride. yout you are evely no ren that at disemir, please intry or eaten year nar permanently delete the communication and any attachments from your system#