Eastern Isotopes, Inc. — Hazardous Materials Safety Interpretation

Page 1of Transportation J.S. Department 400 Seventh St., S.W. Research and Washington, D.C. 20590 A diministrations SEP 2 6 2002 Mr. Jim Kostka Compliance Assistant Ref No: 02-0165 Eastern Isotopes, Inc. P.O. Box 1096 Ashburn, Virginia 20146 Dear Mr. Kostka: This is in response to your May 31, 2002, letter requesting clarification regarding the documentation requirements for Radioactive Material, Excepted Package, and Empty Packaging. In Docket HM-230 (67 ER 21327; April 30, 2002) Section 173.422 states, consistent with the new marking provisions for excepted packages containing radioactive materials in TS-R-1, we propose to eliminate the requirements in § 173.422(a) for a certification statement for such packages. In addition, in §§ 173.422 and 173.428 we are proposing to add the requirement that excepted package-empty package or empty packaging be marked with the UN identification number. The International Air Transport Association (IATA) standards do not have official standing under the Hazardous Materials Regulations (HMR; 49 CFR Parts 171-180); however, the International Civil Aviation Organization's (ICAO) Technical Instructions do have official standing. Section 171.11 of the HMR authorizes the use of the ICAO Technical Instructions in lieu of the HMR for packaging, marking, labeling, classifying, and describing hazardous materials which are transportation by air or by motor vehicle either before or after being transported by air. Part 2; paragraph 7.9.6 of the ICAO Technical Instructions states that, an empty packaging which had previously contained radioactive material may be transported as an excepted package. In addition, Part 3; Special Provision A130 of the ICAO Technical Instructions requires that when this material meets the definitions and criteria of other classes or divisions, it must be classed in accordance with the predominant subsidiary risk. Such material must be declared under the proper shipping name 173.422 020165#

Page 2and UN number appropriate for the material in that predominant Class or division, with the addition of the name applicable to this radioactive material, and must be transported in accordance with provisions applicable to that UN number. I hope this information is helpful. Please contact us if you require additional assistance. Sincerely, Delmer F. Billings Chief, Standards Development Office of Hazardous Materials Standards#

Page 3GIBA Mastern isotope May 31, 2002 Reterford Edward Mazzullo $173.422(aX4)) Director Office of Hazardous Materials Standards U.S. Department of Transportation Marking 400 7' Street, SW Washington, DC 20590 D2-8165 Dear Sir, 171.11 LEM ICAO I am seeking clarification on the use of new UN markings, specifically the use of Radioactive Material, Excepted Package, Empty Packaging. Dastacte 49 CFR. 173.422(a)(4) requires the use of UN2910 and the word "Package', whereas the IATA 43"d edition blue pages requires the use of UN2908 and the word 'packaging'. I need to display the correct wording or'marking' on our returning dose containers which are EMPTY after the customer uses the unit dose radiopharmaceutical. These returns come back to us by ground and by air. I would like to make a sign with the proper markings on it to be used both by air Please advise. Sincerely Jim Kostka Compliance Assistant Eastern Isotopes, Inc. ... •.:: :::: Eastern Isotopes, Inc. • Post Office Box, 1096 = Ashburn, Virginia 20146 - Tel.: (703) 787-7900 • Fax: (703) 787-4079 Website: easternisotopes.com or iba-worldwide.com#