Protecting People and the EnvironmentUNITED STATES NUCLEAR REGULATORY COMMISSION
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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November 7, 1989
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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
