International Radiation Safety Consulting, Inc. — Hazardous Materials Safety Interpretation

Page 1U.S. Department of Transportation Pipeline and Hazardous Materials Safety Administration 1200 New Jersey Avenue. SE Washington. DC 20590 SEP 0 7 2011 Mr. Sean Chapel President International Radiation Safety Consulting, Inc. 17 Norfolk Road Holbrook, MA 02343 Ref. No.: 11-0163 Dear Mr. Chapel: This responds to your July 12, 2011 letter requesting clarification of the Hazardous Materials Regulations (HMR; 49 CFR Parts 171-180) applicable to the transportation of excepted packages for radioactive instruments and articles. Your questions are paraphrased and answered below. Ql: You ask whether, under the requirements for excepted packages for radioactive instruments and articles and contamination control (see §§ 173.424(g) and 173.443(a)), a shipper may perform a wipe test on the instrument itself instead of the actual external surface of the package? AI: Provided certain conditions are met, the answer is yes. As required by § 1 73.424(g), the non-fixed (removable) radioactive surface contamination on the external surface ofthe package must meet the requirements specified in § 173.443(a), which has both a quantitative upper limit, and an as-low-as reasonably achievable component. Section 173.443(a) requires that the level of non-fixed radioactive contamination may not exceed the limits set forth in Table 9 of § 173.443. The shipper must either make one or more package wipe measurements and compare the results against the limits in Table 9, or use another method ofequal or greater efficiency. Ifa shipper utilizes a method which relies on a wipe test on the instrument itself instead ofthe actual external surface ofthe package, it is acceptable provided it is of equal or greater efficiency than the methodology in § 173.443(a)(1) and meets compliance. Q2: You ask whether it would be necessary to wipe test every device to demonstrate compliance, or if a representative sample ofdevices per lot shipped could be wipe tested? Further, you ask what minimum criteria would constitute a representative sample?#

Page 2A2: A physical contamination survey on the outside of every package, or a wipe test on every device, is not mandated prior to each shipment. Furthermore, there is no minimum criterion ofwhat would constitute a sample. The contamination limits must be met, and it is the shipper's responsibility to determine the methodology, as permitted by § 173.443(a)(2), to be utilized by its operations while maintaining compliance with the requirements of the HMR. It should be noted that many shippers survey every package because they do not want to assume the increased perceived risk ofusing an alternate method that might allow a contamination non-compliance issue. I hope this satisfies your inquiry. Please contact us if we can be of further assistance. Sincerely, (W~~ T. Glenn Foster Chief, Regulatory Review and Reinvention Branch Standards and Rulemaking Division#

Page 3Successfol Device Approvals July 12,2011 Jim Williams Radioactive Materials Branch, PHH-23 Office of Hazardous Materials Technology Pipeline and Hazardous Materials Safety Administration U.S. Department ofTransportation 1200 New Jersey Ave. SE East Building, 2nd Floor (PH) Washington D.C. 20590-0001 Dear Mr. Williams: This letter is a request for a formal regulatory interpretation ofthe requirements listed in 49 CFR 173.424(g), which state: (g) The nonfixed (removable) radioactive surface contamination on the external surface ofthe package does not exceed the limits specified in §173.443(a); Is it acceptable for the shipper ofan instrument containing a radioactive source to perform a wipe test on the instrument itself, as opposed to wiping the actual external surface of the package it is being shipped in, in order to demonstrate compliance with this requirement? In addition, please confirm ifit would be necessary to wipe test every device to demonstrate compliance, or if a representative sample ofdevices per lot shipped could be wipe tested. If so please confirm what minimum criteria would constitute a representative sample. 17 Norfolk Rd., Holbrook, MA 02343 USA Ph. 877.266.0794 (U.S.) 781.767.2176 (outside U.S.) Fax: 781.207.0453 www.irsc-inc.com#

Page 42 If you have any questions please call me at 781.767.2176 or email me at schapel@irsc-inc.com. Sincerely, Sean C. Chapel President 17 Norfolk Rd., Holbrook, MA 02343 USA Ph. 877.266.0794 (U.S.) 781.767.2176 (outside U.S.) Fax: 781.207.0453 www.irsc-inc.com#