Implant Technologies — Hazardous Materials Safety Interpretation

Page 1U.S. Department of Transportation Pipeline and Hazardous Materials Safety Administration 1200 New Jersey Ave. SE Washington. D.C. 20590 SfP 1 3 2010 Mr. James V. McManus Sr. Project Manager Implant Technologies 7 Commerce Drive Danbury, CT 96810 Ref. No. 10-0167 Dear Mr. McManus: This responds to your July 26,2010 request for clarification on the Hazardous Materials Regulations (HMR; 49 CFR Parts 171-180). According to your letter and subsequent telephone conversation with a member ofmy staff, you are going to ship "UN 3383, Toxic by inhalation liquid, flammable, n.o.s.," using packaging authorized in §173.226. Specifically, you ask ifyou may use selective testing variation 2 in § 178.601(g)(2) to exclude testing ofthe inner packaging system as normally required in § 173.226(c)(3)(ii). The answer to your question is no. In accordance with 178.601 (g)(2), selective testing of combination packaging variation 2 provides relief from performance testing for outer packaging of combination packaging when inner packaging differ in minor respects from the tested pack~ging configuration. Variation 2 applies to inner packaging that are not themselves subject to performance testing. Section 173.226(c)(3)(ii) requires the inner packaging system to meet the drop test, leakproofness test, and hydrostatic pressure performance tests ofpart 178 subpart M at the Packing Group I performance level. Additionally, the outer packaging ofthe non-bulk combination packaging must also conform to the performance test requirements of subpart M ofpart 178 at the Packaging Group I performance level. As a result ofthe specific requirements for your packaging, you may not use variation 2 to exclude performance testing ofthe inner packaging system required by § 173.226(c)(3)(ii). I hope this answers your inquiry. If you need additional assistance, please contact this Office at 202-366-8553. Sincerely, Ben Supko Acting Chief, Standards Development Office ofHazardous Materials Standards#

Page 2'Drakeford, Carolyn (PHMSA) From: INFOCNTR (PHMSA) -§/7Z./0/ Sent: Tuesday, July 27,20109:18 AM To: Drakeford, Carolyn (PHMSA) lesf-iY)~ Cc: DerKinderen, Dirk (PHMSA) IO-lJJl!" Subject: FW: Request for Interpretation Carolyn, See below, yet another request for a formal written letter of interpretation. -Rob From: jmcmanus@atmi.com [mailto:jmcmanus@atmi.com] Sent: Monday, July 26, 2010 5:04 PM To: INFOCNTR (PHMSA) Subject: Request for Interpretation To Whom it May Concern: I request an interpretation on the following situation in order to answer the question below: 1. The material of interest is UN3383, Toxic by inhalation liquid, flammable, n.o.s. 2. The packaging authorization for UN3383 is CFR 49 173.226. 3. The packaging we are using is a non-bulk combination packaging. 4. The inner packaging system consists of: a. A helium leak tight 1.3 liter stainless steel container that contains the UN3383 liquid. b. A 5 gallon leak tight drum certified to UN1A2 is the second part of the inner packaging system that contains the 1.3 liter stainless steel container. My question pertaining to the above hazardous material and the associated packaging authorization is as follows: Can I use the Selective Testing Variation prescribed in 178.601 (g) (2) to exclude testing of the inner packaging system as normally required in CFR 49 173.226 (c) (2) (iv) if the outer packaging complies with CFR 49 178 (g) (2) (i)-(vii)? I note that 178.601 (g) (2) indicates "inner packagings of any type" for solids or liquids, may be assembled and transported without testing in an outer packaging if the outer packaging complies with CFR 49 178 (g) (2) (i)-(vii). We look forward your interpretation on the above question as we have received conflicting information from several sources regarding this question. 1#

Page 3Kind regards, Jim McManus Jim McManus Project Manager Mobile 203-482-1606 Phone 203-207-9307 ************************* *********** individual or entity named above. If the reader of this message is not the intended recipient, or the employee or agent This email message may contain information that is confidential and/or privileged and is intended only for use of the responsible to deliver it to the intended recipient, you are hereby notified that any dissemination, distribution, or copying of this communication is strictly prohibited. If you have received this communication in error, please notify sendel immediately and destroy the original message. Thank you. 2#