Information Notice 2004-13, Registration, Use, and Quality Assurance Requirements for NRC-Certified Transportation Packages

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: Information Notice 2004-13, Registration, Use, and Quality Assurance Requirements for NRC-Certified Transportation Packages
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