Information Notice 2004-13, Registration, Use, and Quality Assurance Requirements for NRC-Certified Transportation Packages
ML041810535 | |
Person / Time | |
---|---|
Issue date: | 06/30/2004 |
From: | Brach E, Chris Miller NRC/NMSS/IMNS, NRC/NMSS/SFPO |
To: | |
Barr C, NMSS/SFPO 415-4015 | |
Shared Package | |
ML041810497 | List: |
References | |
IN-04-013 | |
Download: ML041810535 (10) | |
UNITED STATES
NUCLEAR REGULATORY COMMISSION
OFFICE OF NUCLEAR MATERIAL SAFETY AND SAFEGUARDS
WASHINGTON, DC 20555 June 30, 2004 NRC INFORMATION NOTICE 2004-13: REGISTRATION, USE, AND QUALITY
ASSURANCE REQUIREMENTS FOR NRC-
CERTIFIED TRANSPORTATION PACKAGES
Addressees
All materials and decommissioning reactor licensees.
Purpose
The U.S. Nuclear Regulatory Commission (NRC) is issuing this Information Notice (IN) to clarify
responsibilities regarding the packaging and transportation of licensed material, as delineated in
10 CFR Part 71. Specifically, this IN is being issued to remind licensees of 10 CFR 71.12 requirements to notify NRC before the first use of NRC-approved transport packages (user
registration), and to ensure licensees have copies of the current Certificates of Compliance
(CoCs), or other approval, and comply with all of their conditions prior to each transport; and, if
necessary, to properly transfer licensed material prior to transport, or delivery to a carrier for
transport.
It is expected that licensees will review this information for applicability to activities involving
transport of licensed radioactive materials in NRC-approved packages for Type B quantities.
Licensees should consider actions, if appropriate, to ensure compliance with packaging and
transport regulatory requirements. However, suggestions contained in this notice do not
constitute NRC requirements; therefore, no specific action nor written response is required.
Description of Circumstances
The NRC staff has recently become aware of several instances of failure to register with NRC
before first use of an NRC-approved transport package, as required by 10 CFR 71.12(c)(3),
compatible Agreement State regulations, and 49 CFR 173.471(a) (note that, effective
October 1, 2004, 10 CFR 71.12 is renumbered 10 CFR 71.17). To help determine the potential
scope of the registration problem, a list of Type B package users filing for reciprocity (see
10 CFR 150.20) in 2003 was compiled and compared to a list of Type B package users
registered in NRCs user database. Although the Type B package users filing for reciprocity in
2003 should have been registered with NRC, some Type B transport package users (primarily
radiographers) were not listed in NRCs user database. Additionally, a few expired CoCs were
listed on 2003 reciprocity forms (NRC Form 241, Report of Proposed Activities in Non- Agreement States, Areas of Exclusive Federal Jurisdiction, or Offshore Waters).
The NRC staff has also found instances where licensees were apparently confused about their
responsibilities under 10 CFR 71.121 in that the licensee assumed a consolidator, consultant, or
carrier was the party responsible for meeting the requirements of 10 CFR 71.12.1 However, only
consolidators, consultants, or carriers who are licensees authorized to possess licensed
material at the transport points of origin, and who are in possession of the material to be
transported, are eligible for general licenses under 10 CFR 71.12.1 Discussion:
Section 10 CFR 71.121 grants an NRC licensee a general license to use an NRC-approved
package to transport, or to deliver to a carrier for transport, licensed material, provided that the
user meets certain requirements, most of which are listed below. The user must:
register with NRC before their first use of the package (send their name, license
number, and package identification number to the Director of the Spent Fuel Project
Office),
have and comply with an NRC-approved Quality Assurance (QA) program (except for
radiographers as noted below), and
have a copy of the CoC, or other approval of the package, and comply with the terms
and conditions of the certificate or approval.
A license to possess radioactive material is a prerequisite for obtaining and using the general
license to ship or transport licensed material, under Part 71. The general license does not
authorize the receipt, possession, or use of byproduct, source, or special nuclear material;
such authorization must be obtained separately pursuant to the regulations found in 10 CFR
Parts 30, 40, and 70 (or compatible Agreement States regulations). Before discussing the
specific requirements of 10 CFR 71.121 listed above, it is important to first establish the roles
and responsibilities of the parties involved in the shipment and transport of licensed radioactive
materials.
Roles of Shipper/Consignor, and Carrier
NRC recognizes that there has been significant confusion regarding the possession and
transfer of licensed material for the purposes of transport, and the roles/responsibilities of the
shipper (consignor) and the carrier during transport. Generally, issues related to the transfer of
radioactive material arise when a service firm (e.g., consolidator, consultant, carrier, etc.)
comes to an NRC licensees facility to collect radioactive materials. Licensees may be
assuming that their materials are being transferred to such firms prior to the shipment.
However, these firms usually do not want to accept responsibility for shipments from the
licensees facilities. A licensee should understand these arrangements, in particular, who has
authorized possession of the materials at the time of shipment. Unless a firm is authorized and
agrees to accept possession of the licensees material prior to any shipment in an NRC-certified
package from the licensees facility, the licensee, not the service firm, is responsible for the
shipment.
Since only the licensee in possession of the material may deliver the material to the carrier, the
licensee that possesses the material should be listed as the consignor on the shipping papers
for the shipment. As such, the consignor/shipper is responsible for compliance with NRC
requirements for the shipment, including meeting all of the general license requirements of 10 CFR 71.121 (e.g., user registration, NRC-approved QA plan, and proper use of current
CoC). Accordingly, NRC views the person who signs the consignors declaration on the DOT
shipping papers as representing the NRC licensee in possession of radioactive material who
offers the material for transport.
User Registration
Section 10 CFR 71.121 grants an NRC licensee a general license to use an NRC-approved
package provided that the licensee meets the conditions of the rule, including registering with
the NRC before first use of the package. Agreement States have adopted regulations
compatible with 10 CFR 71.12,1 and all NRC and Agreement State licensees are required to
abide by Department of Transportation (DOT) regulations, which also require users of NRC-
approved transport packages to register with NRC. Thus, all licensees (both NRC and
Agreement State) using NRC-approved transport packages for Type B and fissile materials
must register with NRC. As discussed in the section above, the licensee/consignor, not the
carrier, is responsible for registering with the NRC. Not only is registration a regulatory
requirement, it is also important for transport package users to register with NRC to ensure that
they are kept informed of changes to package authorizations and other important
communications with respect to transport package use. There are no fees assessed for
package user registration with NRC.
NRC-Approved QA Program
Additionally, an NRC licensee that delivers radioactive material in an NRC-approved package
must have and follow an NRC-approved QA program (see 10 CFR 71.101 for QA
requirements). Again, the licensee/consignor, not the carrier, is responsible for having the
NRC-approved QA program, as required by 10 CFR 71.121 or the comparable Agreement State
requirement. A notable exception is for radiographers licensed under 10 CFR Part 34, who are
required to have written procedures for inspection and maintenance of radiographic Type B
packages [10 CFR 34.31(b)] that meet the NRC QA requirements, making separate QA
programs unnecessary. Therefore, these licensees are exempt from the requirement of
10 CFR 71.121 to have NRC-approved QA programs [see 10 CFR 71.101(g)], although they
must still meet the other requirements of 10 CFR 71.121 to obtain general licenses.
Use of Valid Certificates of Compliance
Section 10 CFR 71.121 also requires that the licensee have in its possession a copy of the CoC,
drawings, and other documents related to the use and maintenance of the packaging and the
actions to be taken for shipment; and complies with the applicable terms and conditions of the
CoC or other approval. Copies of current, approved CoCs are included in the NRC report,
"Directory of Certificates of Compliance for Radioactive Materials Packages" (NUREG-0383),
which is normally updated annually. As discussed above, several CoCs listed on 2003 reciprocity filings by Agreement State licensees have expired or were terminated several years
ago. For example, several reciprocity filings listed model 660B radiography devices (NRC CoC
No. 9033), which expired in June 1999 and was replaced by model 660-OP (currently NRC CoC
No. 9283). A list of recent (since 1997) expired/terminated CoCs and/or changes to package
designs (and corresponding CoC numbers) is provided in Attachment 1. Summary
The general license requirements of 10 CFR 71.121 apply to all NRC-licensees that transport, or deliver to a carrier for transport, licensed material in an NRC-approved transport package.
Transport package users must:
register with NRC before their first use of the package,
have and comply with an NRC-approved Quality Assurance (QA) program (except for
radiographers as noted above), and
have a copy of the CoC, or other approval of the package, and comply with the terms
and conditions of the certificate or approval.
All NRC licensees using NRC-approved transport packages are responsible for ensuring that all
of these requirements have been met, and that they are using currently authorized packages
(see list of approved packages in NUREG-0383). All Agreement State licensees using NRC-
approved transport packages are also required to register with the NRC, to have a valid CoC,
and to meet applicable QA requirements as dictated by their respective Agreement State
regulations. A summary list of relevant Part 71 requirements in question and answer form is
provided in Attachment 2 for additional information. It is expected that licensees will review this
IN for applicability to activities involving transport of licensed radioactive materials in NRC-
approved packages for Type B quantities. Licensees should consider actions, if appropriate, to
ensure compliance with these regulatory requirements.
This IN requires no specific action nor written response. If you have any questions about the
information in this notice, please contact one of the technical contacts listed below or the
appropriate regional office.
/RA/ /RA/
Charles L. Miller, Director E. William Brach, Director
Division of Industrial and Spent Fuel Project Office
Medical Nuclear Safety Office of Nuclear Material Safety
Office of Nuclear Material Safety and Safeguards
and Safeguards
Technical Contacts: Cynthia Barr, NMSS Tomas Herrera, NMSS
(301)415-4015 (301)415-7138 E-mail: csb2@nrc.gov E-mail: txh1@nrc.gov
Attachments: 1. Table of Models with Recently Expired, Terminated, or Modified CoCs
2. Summary Part 71 Requirement Questions and Answers
3. List of Recently Issued NRC Information Notices
4. List of Recently Issued NMSS Information Notices
1 Effective October 1, 2004, 10 CFR 71.12 will be renumbered 71.17 Summary
The general license requirements of 10 CFR 71.121 apply to all NRC-licensees that transport, or deliver to a carrier for transport, licensed material in an NRC-approved transport package.
Transport package users must:
register with NRC before their first use of the package,
have and comply with an NRC-approved Quality Assurance (QA) program (except for
radiographers as noted above), and
have a copy of the CoC, or other approval of the package, and comply with the terms
and conditions of the certificate or approval.
All NRC licensees using NRC-approved transport packages are responsible for ensuring that all
of these requirements have been met, and that they are using currently authorized packages
(see list of approved packages in NUREG-0383). All Agreement State licensees using NRC-
approved transport packages are also required to register with the NRC, to have a valid CoC,
and to meet applicable QA requirements as dictated by their respective Agreement State
regulations. A summary list of relevant Part 71 requirements in question and answer form is
provided in Attachment 2 for additional information. It is expected that licensees will review this
IN for applicability to activities involving transport of licensed radioactive materials in NRC-
approved packages for Type B quantities. Licensees should consider actions, if appropriate, to
ensure compliance with these regulatory requirements.
This IN requires no specific action nor written response. If you have any questions about the
information in this notice, please contact one of the technical contacts listed below or the
appropriate regional office.
/RA/ /RA/
Charles L. Miller, Director E. William Brach, Director
Division of Industrial and Spent Fuel Project Office
Medical Nuclear Safety Office of Nuclear Material Safety
Office of Nuclear Material Safety and Safeguards
and Safeguards
Technical Contacts: Cynthia Barr, NMSS Tomas Herrera, NMSS
(301)415-4015 (301)415-7138 E-mail: csb2@nrc.gov E-mail: txh1@nrc.gov
Attachments: 1. Table of Models with Recently Expired, Terminated, or Modified CoCs
2. Summary Part 71 Requirement Questions and Answers
3. List of Recently Issued NRC Information Notices
4. List of Recently Issued NMNSS Information Notices
DISTRIBUTION:
NRC File Center SFPO r/f NMSS r/f
g:\sfpo\barr\registration_IN2004-13.wpd *=see previous concurrence
OFC: SFPO PMDA IMNS IMNS SFPO SFPO
NAME: CBarr* EKraus* THerrera* ICabrera* RLewis* LCamper*
DATE: 6 / 08 / 04 6 / 06 / 04 6 / 08 / 04 6 / 09 / 04 6 / 09 / 04 6 / 09 / 04 OFC: OGC DWM STP IMNS SFPO
NAME: STreby* JGreeves* JPiccone* CMiller* WBrach/mwh*
DATE: 6 / 15 / 04 6 /22/ 04 6 / 24 / 04 6 / 25 / 04 6 /28 / 04 OFFICIAL RECORD COPY
Attachment 1 Table of Models with Recently Expired, Terminated, or Modified CoCs
Model No. Package ID # (CoC) Status
AI 500 SU USA/9006/B(U) Terminated 7/1/1998 C-8 USA/9128/B(U) Terminated 7/1/1998 CNS 4-85 USA/6244/B(U) Terminated 6/7/2000
GE-500 USA/9049/B( ) Terminated 12/21/2000
IR-50 USA/9156/B(U) Expired 7/31/1999, non-renewable
100, 100A USA/9127/B(U) Terminated 7/1/1998
20, 20A, 50, 50A USA/9127/B(U) Terminated 7/1/1998
3206B, 3218, 3227B USA/9167/B(U) Terminated 7/1/1998
420 USA/9245/B(U) Terminated 10/23/2000
650 USA/9032/B(U) Terminated 10/10/2000
Replaced with Model 650L
CoC No. USA/9269/B(U)-85 issued
11/28/1995 (Rev. 3)
660, 660A, 660AE, 660B, 660BE, 660E USA/9033/B(U) Expired 6/30/1999, non-renewable
Replaced with Model OP- or OPL-660
CoC No. USA/9283/B(U)-85 issued
6/19/1998 (Rev. 1)
6717-B USA/6717/B(U) Expired 11/30/2003 Terminated 11/5/2003
676, 676A, 676AE, 676B, 676BE, 676E USA/9029/B(U) Terminated 3/4/1999
680, 680A, 680AE, 680B, 680BE, 680E USA/9035/B(U) Replaced with Model 680-OP
CoC No. USA/9035/B(U)-85 issued
5/7/1999 (Rev. 18)
684, 684A, 684AE, 684B, 684BE, 686E USA/9028/B(U) Terminated 7/1/1998
715 USA/9039/B(U) Expired 2/28/2003
741, 741A, 741AE, 741B, 741BE, 741E USA/9027/B(U) Replaced with Model 741-OP
CoC No. USA/9027/B(U)-85 issued
5/7/1999 (Rev. 17)
771 USA/9107/B(U) Expired 6/30/2003
820 USA/9137/B(U) Terminated 10/31/1997
850 USA/9147/B(U) Terminated 7/1/1998
864 USA/9166/B(U) Terminated 7/26/1999
920 USA/9143/B(U) Terminated 7/1/1998
934 USA/9243/B(U) Expired 1/31/2001
Attachment 2 Relevant Part 71 Requirements Questions and Answers
To further clarify the responsibilities of NRC licensees who transport, or deliver to a carrier for
transport, licensed material, we pose the following questions and summarize the pertinent Part
71 requirements.
Who is required to obtain a license under Part 71? NRC licensees that intend to ship
(deliver to a carrier for transport) or transport licensed material are required to obtain
general or specific licenses from the Commission per 10 CFR 71.3, unless exempt from
Part 71, as provided in 10 CFR 71.8, 71.9, or 71.10 (10 CFR 71.12 through 71.15 after
October 1, 2004).
Who is exempt from most Part 71 requirements? Specific exemptions include Type A
quantities of radioactive material; most low-specific activity (LSA) or surface
contaminated objects (SCO); and other packages listed in 10 CFR 71.10 (10 CFR 71.14 after October 1, 2004). Licensee shipments of Type B and fissile packages are subject
to the requirements of Part 71.
It is important to note that the Part 71 exemptions listed above do not apply to 10 CFR
71.5, that requires each licensee that transports or ships (delivers to a carrier for
transport) licensed material to comply with the applicable requirements of DOT
regulations found in 49 CFR Parts 170 through 189. Therefore, all NRC licensees, including those that use Type A packages, are subject to DOT regulations and NRC
inspection.
Who may use the general license and who retains possession of the licensed material
during transport? As stated in the IN above, only NRC licensees who are authorized to
possess and who are in possession of the radioactive material may be issued a general
license under 10 CFR 71.12.1 The licensee maintains possession of (i.e., is responsible
for) the licensed material until the transfer of that material to another party that is
authorized to receive it is completed. Normally, it is the licensee at the point of origin
that retains possession of the material until delivery and transfer of the licensed material
to an authorized licensee at the destination point occurs. In fact, the carrier (common
and contract) who transports the licensed material is exempt from the requirements to
obtain a license authorizing possession of the material during transport (e.g., 10 CFR
30.13, 40.12, and 70.12). The carrier simply carries the material to another party
authorized to possess the material and, upon receipt of the material, the transfer is
made.
Attachment 2 Can an Agreement State Licensee Obtain Possession of Licensed Material from a Non- Agreement State (NRC) Licensee? With respect to Agreement State licensees, a
general license is issued, under the reciprocity provisions of 10 CFR 150.20, to perform
work in areas of NRC jurisdiction, provided that the Agreement State license does not
limit its authorized activities to specified installations or locations and the licensee
submits NRC Form 241 to the appropriate NRC regional office. In this case, if the
Agreement State licensee is authorized to possess the material, then an on-site transfer
of the radioactive material from the NRC licensee can occur and the Agreement State
licensee may subsequently deliver the licensed material to a carrier for transport if the
Agreement State licensee complies with 10 CFR 71.121 (e.g., registers with the NRC,
has an NRC-approved QA program, and has and follows the conditions of a valid CoC).
1 Effective October 1, 2004, 10 CFR 71.12 will be renumbered 71.17
Attachment 3 LIST OF RECENTLY ISSUED
NRC INFORMATION NOTICES
_____________________________________________________________________________________
Information Date of
Notice No. Subject Issuance Issued to
_____________________________________________________________________________________
2004-12 Spent Fuel Rod Accountability 06/25/2004 All holders of operating licenses
for nuclear power reactors, research and test reactors, decommissioned sites storing
spent fuel in a pool, and wet
spent fuel storage sites.
2004-11 Cracking in Pressurizer Safety 05/06/2004 All holders of operating licenses or
and Relief Nozzles and in construction permits for nuclear
Surge Line Nozzle power reactors, except those that
have permanently ceased
operations and have certified that
fuel has been permanently
removed from the reactor.
2004-10 Loose Parts in Steam 05/04/2004 All holders of operating licenses
Generators for pressurized-water reactors
(PWRs), except those who have
permanently ceased operations
and have certified that fuel has
been permanently removed from
the reactor.
2004-09 Corrosion of Steel 04/27/2004 All holders of operating licenses
Containment and Containment for nuclear power reactors except
Liner those who have permanently
ceased operation and have
certified that fuel has been
permanently removed from the
reactor vessel.
2004-08 Reactor Coolant Pressure 04/22/2004 All holders of operating licensees
Boundary Leakage Attributable for nuclear power boiling-water
to Propagation of Cracking in reactors (BWRs), except those
Reactor Vessel Nozzle Welds who have permanently ceased
operations and have certified that
fuel has been permanently
removed from the reactor vessel.
Note: NRC generic communications may be received in electronic format shortly after they are
issued by subscribing to the NRC listserver as follows:
To subscribe send an e-mail to <listproc@nrc.gov >, no subject, and the following
command in the message portion:
subscribe gc-nrr firstname lastname
______________________________________________________________________________________
OL = Operating License
CP = Construction Permit
Attachment 4 LIST OF RECENTLY ISSUED
NMSS INFORMATION NOTICES
_____________________________________________________________________________________
Information Date of
Notice No. Subject Issuance Issued to
_____________________________________________________________________________________
2004-03 Radiation Exposures to 02/24/2004 All well-logging licensees.
Members of the Public in
Excess of Regulatory Limits
Caused by Failures to Perform
Appropriate Radiation Surveys
During Well-logging
Operations
2004-02 Strontium-90 Eye Applicators 02/05/2004 All U.S. Nuclear Regulatory
New Calibration Values and Commission (NRC) medical-use
Use licensees and NRC master
materials license medical-use
permittees.
2003-22 Heightened Awareness for 12/09/2003 All medical licensees and NRC
Patients Containing Detectable Master Materials License medical
Amounts of Radiation from use permittees.
Medical Administrations
2003-21 High-Dose-Rate-Remote- 11/24/2003 All medical licensees.
Afterloader Equipment Failure
2003-20 Derating Whiting Cranes 10/22/2003 All holders of operating licenses
Purchased Before 1980 for nuclear power reactors, except those who have
permanently ceased operations
and have certified that fuel has
been permanently removed from
the reactor vessel; applicable
decommissioning reactors, fuel
facilities, and independent spent
fuel storage installations.
Note: NRC generic communications may be received in electronic format shortly after they are issued by
subscribing to the NRC listserver as follows:
To subscribe send an e-mail to <listproc@nrc.gov >, no subject, and the following command in the
message portion:
subscribe gc-nrr firstname lastname
______________________________________________________________________________________
OL = Operating License
CP = Construction Permit