State of Wisconsin Department of Health Services — Hazardous Materials Safety Interpretation

Page 1U.S. Department of Transportation Pipeline and Haz.ardous Materials Safety Administration MAR 5 2010 1200 New Jersey Ave, SE Washington, D.C. 20590 Mr. Jason Hunt State of Wisconsin Department of Health Services Radiation Protection Section One West Wilson Street. Room 148 P.O. Box 2659 Madison, Wisconsin 53701-2659 Ref. No. 09-0286 Dear Mr. Hunt: This responds to your email dated December 3, 2009 requesting clarification of the Hazardous Materials Regulations (HMR; 49 CFR Parts 171- t80). You describe a scenario in which a nuclear pharmacy ships radioactive material to nuclear medicine departments. The nuclear pharmacy requires the end users to ship the packaging, "ammo can and empty pigs," back to the nuclear pharmacy in accordance with § 173.421 (Excepted packages for Class 7 (radioactive) materials). Your questions pertaining to this scenario are summarized and answered as follows: Q 1) Are licensees required to perform a survey (exposure or contamination) of "ammo cans" that are shipped back to a nuclear pharmacy in accordance with § 1 73.4 21 ? No. Section 173.421 requires that the radiation level at any point on the external surface of the package does not exceed 0.005 mSv/hour (0.5 mremlhr). In addition, the nonfixed (removable) contamination on the external surface of the package must not exceed the limits in § I 73.443(a). The shipper must ensure that the package is within these regulatory limits when offered for transportation and transported. This generally implies that it is necessary for the shipper to conduct a survey to ensure compliance. However, this regulation provides the shipper with latitude in their methods ofensuring compliance with the radiation and contamination limits; procedures other than measurements, such as quality assurance and quality control. are acceptable means of ensuring compliance. Q2) ffthe contamination exposure of the "ammo cans" exceeds the levels in §§ t73.421 (a)(2) and (3) and the licensee does nothing, will the licensee be cited? It is the shipper's responsibility to ensure compliance with § 173.421. Therefore, if the "ammo cans" exceed the radiation level or contamination limits of § 173.421, they would be in violation of the HMR and could be cited.#

Page 2Q3} Are licensees in violation of § 171.2 when a nuclear pharmacy requires them to ship empty 4'ammo cans" as "Excepted packages for Limited Quantities of Class 7 (radioactive) materials? No. Provided the licensees comply with the requirements of the HMR applicable to Limited Quantity Class 7 (radioactive) materials (see § 173.421). I hope this answers your inquiry. If you need further assistance, please contact this office at 202· 366-8553. Sincerel.~' , \ fIl~ harles E. Betts hief, Standards Development ce of Hazardous Materials Standards#

Page 3Drakeford, Carolyn (PHMSA) From: Betts, Charles (PHMSA) Sent: Thursday, December 03, 2009 8:40 AM s Cit1-e¥l la..u.io To: Drakeford, Carolyn (PHMSA) Cc: Plessas, Karen (PHMSA); Boyle, Rick (PHMSA) Cs 113 . tfz, 1 Subject: FW: Interpetation Request ~ 111. 4 Importance: High ~AM Oq-62<6 (, -----Original Message----From: Plessas, Karen (PHMSA) Sent: Thursday, December 03, 2009 8:35 AM To: Betts, Charles (PHMSA)i Boyle, Rick (PHMSA) Cc: Rogers, Cheryl K - DHSi Schmidt, Paul S - DHS: Sulas, Diana M - DHS; 'Hunt, Jason H DHS' Subject: RE: Interpetation Request Charlie, Jason Hunt from the State of Wisconsin is requesting a formal interpretation on a radioactive materials issue, so I am forwarding his request to you and Rick for disposition. Thanks, Karen Karen Plessas Radioactive Materials Program Manager Office of Hazardous Materials Enforcement Pipeline and Hazardous Materials Safety Administration 202-366-5267 -----Original Message----From: Hunt, Jason H - DHS [mailto:Jason.Hunt@dhs.wisconsin.gov] Sent: Wednesday, December 02, 2009 4:40 PM To: Plessas, Karen (PHMSA) Cc: Rogers, Cheryl K - DHS; Schmidt, Paul S - DHSi Sulas, Diana M - DHS Subject: Interpetation Request Karen I know I had emailed you awhile back and I'm wondering if I can get a formal interpretation by DOT of this requirement. Rule Reference: 49 CFR 173.421 Excepted Packages for limited quantities of Class 7 (radioactive) materials (2) The radiation level at any point on the external surface of the package does not exceed 0.005 mSv/hour (0.5 mrem/hour) . (3) The nonfixed (removable) radioactive surface contamination on the external surface of the package does not exceed the limits specified in 49 CFR 173.443(a). Radioactive Material Regulation Review - December 2008 I understand this states in the note that 'This document is for general guidance only and must not be used to determine compliance with 49 CFR Parts 100-185. Page 86 "This last requirement to ensure compliance with radiation and contamination limits of §§ 173.441 and 173.443 does not require that surveys or direct measurement be made. Both 1#

Page 4sections give shippers latitude in their methods of ensuring compliance with the radiation and contamination limits; procedures other than measurements, such as quality assurance and qual control, are acceptable means of ensuring compliance. However, if a compliance inspection during transportation determines that radiation or contamination levels exceed the limit, the shipper is subject to a citation." The question has arose in our office for Nuclear Medicine Departments that ship (without any material except the empty pigs) ammo cans back to a radiopharmacy under 49 CFR 173.421 (Excepted Packages for limited quantities of Class 7 (radioactive) materials. The Nuclear Pharmacy requires that the licensee ship these ammo cans back under 49 CFR 173.421. Two questions: 1. Are the licensee's required to perform a survey (exposure or contamination) of these ammo cans, being shipped back under 49 CFR 173.421? If no survey is required what does DOT require, procedures (see guidance paragraph)? Is it then acceptable for the licensee to do nothing with these ammo cans, understanding that if the contamination or exposure exceeding the levels in 49 CFR 173.421 (2)&(3) they will be cited? 2. The licensee's have indicated that by the Nuclear Pharmacy requiring them to ship back these empty ammo cans as Excepted for Limited Quantities of Class 7 (radioactive) materials that they are in violation of 49 CFR 171.2. Is this a correct interpretation by the licensees? If I can provide any further clarification please let me know. Jason Hunt ********** NOTICE: This E-mail and any attachments may contain confidential information. Use and further disclosure of the information by the recipient must be consistent with applicable laws, regulations and agreements. If you received this E-mail in error, please noti the sender; delete the email; a~.d do not use, disclose or store the information it contains. Jason H Hunt Radiological Emergency Preparedness State of Wisconsin Department of Health Services Radiation Protection Section 1 West Wilson Street Room 148 P.O. Box 2659 Madison, Wisconsin 53701-2659 (608) 266-9443 (Office) (608) 219-7843 (Cell) (608) 267 3695 Fax Visit our Website at: http://dhs.wisconsin.gov/dph_beh/RadiatioP/Index.htm 2#