United States Nuclear Regulatory Commission - Protecting People and the Environment

Bulletin 95-01: Quality Assurance Program For Transportation of Radioactive Material

                                 UNITED STATES             OMNB No.: 3150-0011
                         NUCLEAR REGULATORY COMMISSION            NRCB:  95-01
               OFFICE OF NUCLEAR MATERIAL SAFETY AND SAFEGUARDS
                            WASHINGTON, D.C.  20555

                               January 13, 1995


NRC BULLETIN 95-01:  QUALITY ASSURANCE PROGRAM FOR TRANSPORTATION 
                     OF RADIOACTIVE MATERIAL

Addressees

      For Action - All radiography licensees

      For Information - None

Purpose

The U.S. Nuclear Regulatory Commission is issuing this bulletin to (1) notify
action addressees about the failure of some licensees to have NRC-approved
quality assurance (QA) Programs for transportation of radioactive material,
(2) request that all action addressees implement the actions described herein,
and (3) require that all action addressees answer the questions in
Attachment 1 and return the completed form to NRC. 

Description of Circumstances

Most radiographers perform activities that require NRC-approved QA Programs. 
These activities involve transport, or delivery to a carrier for transport, of
licensed material in Type B packaging.  Examples include transport of
radiography devices to and from work sites, and shipment of radiography
sources to source suppliers.  However, NRC has noted that not all
radiographers have NRC-approved QA Programs.  Furthermore, a review of NRC
materials license records shows that there are radiographers who may be
transporting, or delivering to carriers for transport, licensed material in
Type B packagings without having NRC-approved transportation QA Programs.

NRC has also conducted inspections of radiographers with NRC-approved QA
Programs applicable to procurement, use, maintenance, and repair of Type B
packaging used in transport of radioactive material.  These radiographers
transport special form radioactive material in packagings for which
certificates of compliance (COCs) have been issued by NRC.  The inspections
were conducted to determine compliance with the transportation QA requirements
of 10 CFR 71.12.

The results of the inspections showed that four out of the five radiographers
inspected had serious shortcomings in the implementation of their
transportation QA programs.  In most instances, procedures used to implement
their transportation QA programs were incomplete, were not available, or were
not followed.  QA records, which document the results of required QA
activities, were found to be incomplete, inaccurate, or missing.  

9501090219.                                                            NRCB 95-01
                                                            January 13, 1995
                                                            Page 2 of 4


Discussion

The provisions of 10 CFR 71.12 provide for the issuance of a general license
to radiographers to transport, or deliver to a carrier for transport, licensed
material in a packaging for which a COC has been issued by NRC.  To comply
with the general license provisions of 10 CFR 71.12, the actions requested to
be taken by radiographers before transportation activities are performed
include the following:

1.    Obtain NRC approval of transportation QA Programs.

2.    Implement transportation QA Programs using written procedures.

3.    Review records on activities affecting quality.

4.    Register with NRC as users of Type B packagings utilized in
      transportation activities.

Requested Actions

Radiographers are requested to fill out the enclosed form, return the
completed form to NRC, and take the following actions relating to compliance
with regulatory requirements:

1.    QA Program - Review your operating activities.  If you perform
      transportation activities, as described in 10 CFR 71.12(a), and you do
      not currently have an NRC-approved transportation QA Program, prepare
      and submit to NRC, within 60 days of the date of this bulletin, a
      transportation QA Program that satisfies the requirements of Subpart H
      of 10 CFR Part 71.  A $370.00 application fee, as required by 10 CFR
      170.31(10)(B), must also be submitted with the application.  Please note
      that Regulatory Guide 7.10, "Establishing Quality Assurance Programs for
      Packaging Used in the Transport of Radioactive Material," may be helpful
      to you in developing your transportation QA Program.

2.    Implementing Procedures - Review your operating procedures.  If you are
      required to have a transportation QA Program, as required by 10 CFR
      71.12(b), and do not have written procedures that implement each element
      of your transportation QA program in accordance with the requirements of
      10 CFR 71.111, develop these procedures and implement them within 60
      days of the date of this bulletin.  Please note that methods for
      complying with each of the criteria of Subpart H of 10 CFR Part 71,
      applicable to your transportation activities, and all other activities
      important to safety, must be prescribed and accomplished in accordance
      with documented procedures, instructions, and drawings.  The procedures
      should not be submitted to NRC at this time.  However, these procedures
      must be implemented and kept on file at your location for future
      inspections.  .                                                         NRCB 95-01, Pg 3 of 4
                                                         January 13, 1995
                                                            
3.    QA Records - Review your operating records.  If you do not maintain
      records describing activities affecting quality, maintain records of
      each shipment of licensed material, and maintain records furnishing
      evidence of the quality of Type B packaging in accordance with the
      requirements of 10 CFR 71.135, 71.91(a), and 71.91(c), respectively, you
      should:

      a.  Identify all of the records that are required by your transportation
          QA Program and the records that are incomplete or missing.

      b.  Document, in a status report, all the instances where you find that
          your QA records are incomplete or missing, and keep this status
          report on file.

          Caution:  Do not attempt to falsify any QA records.  If QA records
          are incomplete or missing, state so in your status report.  The
          status report should not be submitted to NRC at this time.  However,
          this information must be documented and kept on file at your
          location for future inspections.  Full compliance must be achieved
          within 60 days from the date of this bulletin.

      c.  Take the necessary corrective steps to assure that you document, in
          the future, the results of all QA activities that are described in
          your transportation QA Program.

4.    Packaging Registration - Review your transportation packaging
      registrations.  If you are not registered as a user of all the models of
      Type B transportation packagings you are utilizing, submit to NRC within
      60 days of the date of this bulletin a written request to be registered
      in accordance with 10 CFR 71.12(c)(3).  You are also required to submit
      to NRC, before the first use of new Type B packaging models, a written
      request to be registered as a user of the Type B packaging.  The
      requests should include the radiographer's name, NRC license number,
      transportation QA Program approval number, Type B packaging
      identification numbers, and corresponding COC numbers.

Transportation QA Programs, application fees, and requests to be registered as
users of packagings should be sent to Mr. Robert L. Baer, Chief, Source
Containment and Devices Branch, Office of Nuclear Material Safety and
Safeguards, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001.

Please note that it will be considered a willful violation of NRC regulatory
requirements, therefore subject to civil penalties and criminal penalties
under 10 CFR 71.100, if, subsequent to the issuance of this bulletin, you
perform transportation activities requiring an NRC-approved QA Program and do
not:  have, or take steps in accordance with this bulletin to put into effect,
an NRC-approved QA Program for transportation; implement your QA program
through detailed procedures; maintain QA records; or register as a user of the
Type B transportation packagings you are utilizing.  All such transportation
activities must be stopped until you have a transportation QA Program approved
by NRC, have procedures in place that implement your transportation QA
Program, and are registered as a user of the Type B transportation packagings.                                                            NRCB 95-01
                                                            January 13, 1995
                                                            Page 4 of 4

you are utilizing.  Your QA program, implementation procedures, QA records,
and Type B packagings registration will be subject to future inspections.

Required Responses

Within 30 days of the date of this bulletin, each action addressee is required
to complete and submit the form provided in Attachment 1.  Address the
completed form to the U.S. Nuclear Regulatory Commission, ATTN:  Document
Control Desk, Washington, D.C. 20555-0001, under oath or affirmation, under
the provisions of Section 182a, Atomic Energy Act of 1954, as amended.  

In preparing your response, if you discover incomplete or missing records, you
should so indicate in a status report and keep this report on file.  Creation
of false records may be subject to civil and criminal sanctions.

Paperwork Reduction Act Statement

The information collections contained in this request are covered by the
Office of Management and Budget clearance number 3150-0011, which expires July
31, 1997.  The public reporting burden for this collection of information is
estimated to average 2 hours per response, including the time for reviewing
instructions, searching existing data sources, gathering and maintaining the
data needed, and completing and reviewing the collection of information.  Send
comments regarding this burden estimate or any other aspect of this collection
of information, including suggestions for reducing this burden, to the
Information and Records Management Branch, U.S. Nuclear Regulatory Commission,
Washington, D.C. 20555-0001, and to the Desk Officer, Office of Information
and Regulatory Affairs, NEOB-10202 (3150-0011), Office of Management and
Budget, Washington, D.C. 20503.

If you have any questions about this matter, please contact one of the
technical contacts listed below.

                                    /S/'D BY CJPAPERIELLO

                                    Carl J. Paperiello, Director
                                    Division of Industrial and Medical 
                                      Nuclear Safety
                                    Office of Nuclear Material Safety
                                      and Safeguards

Technical contacts:  Thomas Matula, NMSS 
                     (301) 415-7873
                        
                     John Jankovich, NMSS 
                     (301) 415-7274 

Attachments:
1.    Quality Assurance Program for 
        Transportation of Radioactive Material.
              Instructions for Completing and Returning the Form


You are required to complete the questions on the following pages and complete
and sign the statement following the questions.

Please remove the pages from this bulletin by tearing along the perforated
line.

Fold the pages in half and staple them closed.

Apply correct postage on the back page and complete the return address
section. 

Mail your response to NRC within 30 days of the date of this bulletin..ENCLOSURE TO NRC BULLETIN 95-01
QUALITY ASSURANCE PROGRAM 
FOR TRANSPORTATION OF RADIOACTIVE MATERIAL

Radiographers are required to answer the following questions.  Attach
additional
pages if more space is needed to provide complete answers.

Mail this completed form, with any attachments, within 30 days of the date of
this bulletin to the U.S. Nuclear Regulatory Commission, ATTN:  Document
Control
Desk, Washington, D.C. 20555-0001.

Licensee identification information:

     Licensee Name:      __________________________________________
     Address:            __________________________________________
                         __________________________________________
     Phone No.:          __________________________________________


1.   Do you have a Quality Assurance (QA) Program approved by NRC in
accordance
     with the requirements of 10 CFR 71.12(b)?

                              Yes_____     No_____

     a.   If the answer to Question Number 1 is "Yes," enter your
transportation
          QA Program Approval Number in the space below and skip Question
Numbers
          2 and 3.  Answer Question Number 4.

          Transportation QA Program Approval Number ________.

     b.   If the answer to Question Number 1 is "No," answer Question Numbers
2
          and 3.

2.   Do you procure, use, maintain, or repair Type B packaging for which a
     Certificate of Compliance (COC) has been issued by NRC?  Please note that
     radiography devices are usually Type B packagings.

                              Yes_____     No_____

3.   Do you transport, or deliver to a carrier for transport, licensed
material
     in Type B packaging for which a COC has been issued by NRC?  Please note
     that this activity includes transport of radiography devices to and from
     work sites and shipment of radiography sources to source suppliers.

                              Yes_____     No_____        .     a.   If the answer to Question Numbers 2 or 3 is "Yes," you are required
to
          have a transportation QA Program approved by NRC in accordance with
10
          CFR 71.12(b).  If you have not already done so, prepare and submit
your
          transportation QA Program to NRC following the directions presented
in
          "Requested Actions" (Page 2, Item 1) in the body of this bulletin. 
          Answer Question Number 4.

     b.   If the answers to Question Numbers 1, 2, and 3 are "No," you may
skip
          Question Numbers 4 through 8.  Complete and sign the statement
          following the questions, and return this form to NRC by following
the
          mailing directions at the top of this form.

4.   Do you have written procedures that implement each element of your
     transportation QA program in accordance with the requirements of 10 CFR
     71.111?  

                              Yes_____     No_____

     a.   If the answer to Question Number 4 is "Yes," answer Question Numbers
5,
          6, and 7.

     b.   If the answer to Question Number 4 is "No," and you determined that
you
          are required to have a transportation QA program, develop these
          procedures and implement them within 60 days of the date of this
          bulletin as described in "Requested Actions" (Page 2, Item 2) in the
          body of this bulletin.  The procedures should not be submitted to
NRC
          at this time.  However, these procedures must be implemented and
kept
          on file at your location for future inspections.  Answer Question
          Numbers 5, 6, and 7.

5.   Do you maintain records describing activities affecting quality, your
     transportation QA program, and your implementation procedures in
accordance
     with the requirements of 10 CFR 71.135?

                              Yes_____     No_____

6.   Do you maintain records of each shipment of licensed material in
accordance
     with the requirements of 10 CFR 71.91(a)?

                              Yes_____     No_____

.7.   Do you maintain records furnishing evidence of the quality of Type B
     packaging for activities such as inspections, tests, and audits, and
     procurement, maintenance, repair, and replacement of packagings in
     accordance with the requirements of 10 CFR 71.91(c)?

                              Yes_____     No_____

     a.   If the answer to Question Numbers 5, 6, and 7 are "Yes," answer
          Question Number 8.

     b.   If the answer to Question Numbers 5, 6, or 7 is "No," and you
          determined that you are required to have a transportation QA
program,
          document in a status report all the instances where you find that
your
          QA records are incomplete or missing, and keep this status report on
          file as described in "Requested Actions" (Page 3, Item 3) in the
body
          of this bulletin.

          Answer Question Number 8.

8.   Are you registered as a user of all models of Type B packagings that you
are
     utilizing for which COCs have been issued by NRC in accordance with the
     requirements of 10 CFR 71.12(c)(3)?

                              Yes_____     No_____

     If the answer to Question Number 8 is "No," and you determined that you
are
     required to have a transportation QA program, prepare and submit your
     request to be registered as a user of packagings following the directions
     presented in "Requested Actions" (Page 3, Item 4) in the body of this
     bulletin.  

Complete and sign the following statement, and return this form to NRC by
following the mailing directions at the top of this form.

I hereby certify under penalty of perjury and under the laws of the United
States
of America that the foregoing is true and correct.

     Name: ____________________________________________________
     
     Title: ___________________________________________________

     Signature: ___________________________ Date: _____________.

























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