United States Nuclear Regulatory Commission - Protecting People and the Environment

Information Notice No. 89-74: Clarification of Transportation Requirements Applicable to Return of Spent Radiopharmacy Dosages From Users to Suppliers

                                UNITED STATES
                        NUCLEAR REGULATORY COMMISSION
              OFFICE OF NUCLEAR MATERIAL SAFETY AND SAFEGUARDS
                           WASHINGTON, D.C.  20555

                              November 7, 1989


Information Notice No. 89-74:  CLARIFICATION OF TRANSPORTATION 
                                   REQUIREMENTS APPLICABLE TO RETURN OF 
                                   SPENT RADIOPHARMACY DOSAGES FROM USERS TO 
                                   SUPPLIERS 

Addressees: 

All manufacturers and distributors of radiopharmaceuticals for medical use, 
nuclear pharmacies, and medical licensees. 

Purpose: 

This notice is provided to answer questions that frequently have arisen 
about the regulatory requirements applicable to transportation of packages, 
containing radioactive materials in the form of "spent" radiopharmacy 
dosages, from the user back to the original supplier.  Most of these 
questions have involved the performance of "shipper" responsibilities in 
such shipments. 

It is expected that addressees will review the information here for 
applicability to their licensed activities, and consider actions, as 
appropriate, to avoid problems in transport of such materials.  However, 
suggestions contained in this notice do not constitute any new U.S. Nuclear 
Regulatory Commission (NRC) requirements, and no written response is 
required. 

Background: 

In the practice of nuclear medicine in the United States, many thousands of 
routine shipments of diagnostic radiopharmaceuticals are made each day.  
Most of these shipments are from the "supplier" radiopharmacy, using private 
vehicles, to the licensee "user," e.g., a hospital or physician.  One major 
supplier, in fact, transports between 1000 to 3000 shipments daily.  As a 
part of the process, the user-licensee then returns such packages to the 
supplier, now containing residual "spent" dosages, contaminated syringes, 
syringe shields, and multi-dose vials.  The user places these materials in 
the original as-received packagings, which are then picked up routinely by 
the supplier at the time "fresh" packages are delivered to the users. 

Discussion: 

Pursuant to 10 CFR Section 71.5, NRC licensees who either transport licensed 
radioactive material outside of their place of use, or deliver such material 
to a carrier for transport, must comply with the applicable requirements of 
the U.S. Department of Transportation (DOT) regulations 49 CFR Parts 170 to 
179.  




8911010053
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Radiopharmacy material shipments almost always involve situations where the 
supplier is a "shipper" acting as a private carrier.  The hospital or 
physician "user" most often is transferring the residual spent-dosage 
packages to the supplier, who then also assumes responsibility for 
performing the "shipper" functions, as well as the carrier functions. 

The questions/answers that follow are intended to clarify the most 
frequently asked questions which have arisen: 

Q1.  Who must act as the "shipper?"

  A. Either party, e.g., the radiopharmacy (supplier) or its customer (user)
     may act as the shipper.  DOT regulations provide no specific definition
     of a "shipper."  The regulations do prescribe many requirements 
     applicable to shippers, consignors, or the "...person who offers for 
     transport." DOT has taken the position that shipper functions actually 
     may be performed by more than one party.  This is, of course, the 
     situation in the case of radwaste "brokers."  In that case, the waste 
     generator may perform certain of the shipper functions, such as 
     filling, closing, and marking the packages and preparing a shipping 
     paper.  The generator then transfers the shipment to the broker, who 
     receives and takes title to the packages, prepares a new manifest, and 
     loads the package onto his vehicle for transport to a collection point 
     or to a burial site.  The broker, in effect, becomes the shipper acting 
     as a private carrier.  Likewise, in radiopharmacy shipment operations, 
     the supplier functions as a shipper acting as a private carrier, in 
     both the delivery of fresh packages to the user, as well as in the 
     pickup of the spent-dosage packages from the user.  In any case, all 
     parties acting as shippers assume liability for any violations that may 
     occur. 
     
Q2.  In the case of radiopharmacy spent-dosage shipments from the user back 
     to the supplier, who is it preferable to have act as the shipper?

  A. As stated previously, either party may act as the shipper, but it is 
     usually preferable that the supplier assume the responsibility.  That 
     is because the supplier is generally more knowledgeable than the user 
     about regulatory requirements for shippers and, likewise, is more apt 
     than the user to be adequately equipped to meet those requirements.  
     NRC strongly recommends that the supplier and the user sign an 
     agreement clearly delineating the respective roles and responsibilities 
     of each party, as they relate to shipper functions, thus eliminating 
     any potential misunderstandings.  With such a written agreement, the 
     supplier may rely on the user to act as his agent in carrying out 
     certain shipper functions.  In such a case, NRC  will hold that 
     supplier totally responsible for ensuring that all shipper 
     requirements are met.  The agreement should be maintained on file and 
     furnished to an inspector upon request.  In the absence of such a 
     written agreement, NRC will generally consider the end-user licensee 
     to be solely responsible for compliance with regulatory shipper 
     requirements when returning radiopharmacy packages to the supplier.  
     This is because the end-user in this case is the point of origin of the 
     shipment. 
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Q3.  What quality control measures would be appropriate on the part of the 
     supplier? 

  A. The return of spent radiopharmacy dosages as limited-quantity packages 
     is not technically subject to the formal shipper requirements for a 
     quality control program, as outlined in 49 CFR Section 173.475, as 
     would be for instance, the shipping of labeled Type A packages.  
     However, if the supplier relies on the user to perform certain shipper 
     functions on his behalf, it is appropriate that the supplier establish 
     procedures to ensure compliance with shipping requirements for 
     limited-quantity packages.  Such a program should include:  
     establishment and dissemination of packaging procedures for the users 
     to follow; provision for training of the involved user personnel; 
     periodic audits by the supplier of the user's performance, to identify 
     discrepancies; and provisions to effect corrective actions by the user 
     when discrepancies are observed.  The specifics of this quality control 
     program should be covered in the written agreement between supplier and 
     end user.  (See Question 2.) 
     
Q4.  Limited-quantity packages of return shipments of spent dosages 
     sometimes are placed within opaque plastic bags which may be either 
     five-sided slipcovers or six-sided covers, providing almost total 
     enclosure of the shipment.  This procedure often is used in lieu of 
     performing contamination surveys to assure compliance with 49 CFR 
     Subsections l73.42l(c) and 173.443(a).  Please comment on this?

  A. Yes.  In the first place, the two types of bags in question do not 
     afford the same quality of protection.  The slipcover bags, since they 
     do not totally enclose the packaging, are not as effective as the 
     six-sided covers in preventing contamination.  Although either of the 
     bags may be a means of avoiding surface contamination, this is not the 
     intended use.  The primary purpose of both types of bags is to display 
     the limited-quantity statement required by 49 CFR Subsection 173.421-1 
     and to cover the labels and marking that were appropriate when the 
     package first came into the user's facility.  In order to ensure 
     compliance with the limits for surface contamination, as stated in 
     Subsection 173.421(c), and certified to by the statement on the bag, 
     NRC strongly recommends that a contamination survey be performed, 
     although this is not mandatory for limited-quantity packages.  If 
     contamination levels are found to exceed the regulatory limits of 
     Subsection 173.443(a), the user or the supplier (if that supplier has 
     assumed responsibility for the shipper functions) will be found to be 
     in violation of the section, regardless of whether a contamination 
     survey was made. 

Q5.  Some radiopharmaceuticals are returned to a supplier unused by the 
     the end user and not "spent."  These packages will usually be Type A, 
     since they exceed the activity limits for a "limited quantity," as 
     specified in 49 CFR Sections 173.421 to 173.423.  Does this present 
     any complications? 
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  A. Definitely.  Different regulatory requirements are specified for 
     packaging, labeling, marking, and shipping papers for Type A packages.  
     If the end user fails to inform the supplier that such packages are not 
     limited-quantity, the packagings, labels, markings, and shipping papers 
     may not be appropriate to the material being returned.  Whatever 
     arrangements have been established in the written agreement between the 
     two parties, as to who performs the specified shipper functions, should 
     also hold for these situations.  The more formal requirements for a 
     quality control program, as outlined in 49 CFR Section 173.475, would 
     now apply for a package that contains more than a limited quantity, 
     e.g., a Type A package. 

Q6.  Packages containing residual materials and spent dosages usually 
     contain much less radioactivity than the original, incoming Type A, 
     labeled packages.  What are the principal requirements applicable to 
     such limited quantitites in order that they might qualify as 
     "Radioactive Material, limited quantity" packages? 

     A. The requirements of 49 CFR Section 173.421, Subsection 173.421-1, 
        and Section 173.423 apply. 
        Briefly, these requirements state that: 

          1. The package must be "strong, tight..."; 

          2. The radiation level at any point on the external surface of the
             package may not exceed 0.5 mrem/hr; 

          3. The radioactive content may not exceed the limits specified in 
             49 CFR Section 173.423; 

          4. Removable radioactive surface contamination on the exterior of 
             the package may not exceed the prescribed limits, e.g., 2,200 
             d/m/100 cm2 [49 CFR Subsection 173.443(a)]; 

          5. The outside of the inner packaging, or if there is no inner 
             packaging, the outside of the package itself must be marked 
             "RADIOACTIVE;" and, 

          6. A notice, with prescribed wording per 49 CFR Subsection 
             173.421-1, must be included in, on or identifiably with the 
             package, certifying that the package meets the requirements for 
             limited-quantity radioactive materials. 

Q7.  I understand that distribution of nuclear medicine materials in the 
     United States is largely accomplished by a network of non-licensed 
     contract motor and air carriers who operate under exemptions issued 
     by DOT (DOT E-8308 for highway shipments and DOT E-7060 for air 
     shipments).  Does this information notice relate to those shipments? 
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  A. No.  The contract carriers involved as parties to those two exemptions 
     are license-exempt and therefore subject solely to DOT jurisdiction. 
     In effect, they are responsible for the carrier requirements of DOT 
     regulations, not the shipper requirements.  They are also responsible 
     for maintenance of the radiation-protection programs, as specified in 
     each exemption.  In cases where "spent" packages of MO 99 - TC 99 
     generators are being returned by an end-user to a supplier using the 
     contract carrier, the end-user is the originator of the return shipment 
     and clearly is responsible for the shipper functions. 




                                  Robert F. Burnett, Director
                                  Division of Safeguards and
                                    Transportation
                                  Office of Nuclear Material Safety
                                    and Safeguards


Technical Contact:  A. W. Grella, NMSS
                    (301) 492-3381

Attachment:  List of Recently Issued NRC Information Notices

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