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**Service Center**

**Safety Guide**

***Defense Programs***

***Package Certification***

***and***

***Offsite Transportation***

***Authorization***

***Guide***

**SG-500**

Revision 3

July 2003

**TABLE OF CONTENTS**

**[SECTION]{.underline}**

[**Foreword**](#foreword)

1.  [**General Overview**](#general-overview)

2.  **Responsibilities**

    1.  [Introduction](#Responsibilities_Introduction)

    2.  [Responsibilities](#Responsibilities_Responsibilities)

        1.  [DOE/NNSA Headquarters](#Responsibilities_HQ)

        2.  [DOE/NNSA Certifying
            Official](#Responsibilities_Certifying_official)

        3.  [PCD Manager](#Responsibilities_PCD_Manager)

> 2.2.3.1 [PCD Certification Engineers (CEs)](#Responsibilities_CEs)
>
> 2.2.4 OST

1.  [OST_Planning_Staff](#OST_Planning_Staff)

2.  [OST Engineering Assistance Staff](#engineeringassurance-staff)

> 2.2.5 [Federal DOE/NNSA Site Line
> Manager](#Federal_DOE_NNSA_Site_Line_Managers)

6.  [DOE/NNSA Package Line Managers](#doennsa-package-line-managers)

7.  [Weapon System Program Manager](#Weapon_System_Program_Manager)

8.  [SARP Owner](#SARP_Owner)

9.  [Package Owner](#package-owner)

10. [Site Approved to Perform Maintenance on DOE/NNSA Certified
    Packages](#site-approved-to-perform-maintenance-on-doennsa-certified-packages)

11. [Site Approved to Provide Packaging
    Supplies](#site-approved-to-provide-packaging-supplies)

12. [SARP/TSRA Development
    Organization](#sarptsra-development-organization)

13. [OTA/OTC Applicant](#OTA_OTC_Applicant)

14. [OTA/OTC Users (consignors and
    consignees)](#otaotc-users-consignors-and-consignees)

15. [Technical Support Contractor](#technical-support-contractor)

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2.  [Graded Approach](#graded-approach)

3.  [Applicable
    Standards/Requirements](#applicable-standardsrequirements)

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3.  **Programs and Processes**

    1.  [Introduction](#Introduction_Programs_Processes)

    2.  [Cargo Packing, Loading and Transportation
        Requirements](#CArgo_Packing_Loading_Transportation_Req)

    3.  [Pre-Packaging/Shipment Determinations and Document
        Requirements](#Prepackaging_Shipment_Determination_Docu)

    4.  [Type A Quantity RAM](#Type_A_Quantity_RAM)

        1.  [DOT Compliant Shipments](#DOT_Compliant_Shipments)

        2.  [Type AF Package Certified by United Kingdom Ministry of
            Defence (UK MOD) Transported in
            TSS](#Type_AF_Packages_Certified_By_UK)

        3.  [Shipment of Nuclear Weapon Special Assemblies that contain
            less than Type B quantity of RAM or no
            RAM](#Shipment_of_Non_HiFi_NELAs)

> 3.5 [Type B Quantity RAM](#type-b-quantity-ram)

1.  [Type B Packaging Certified Under an DOE/NNSA
    OTC](#type-b-packaging-certified-under-an-doennsa-otc)

> [Joint PCD CE, Site POC and Packaging Line Manager Packaging Project
> Checklist](#joint-pcd-certification-engineer-site-poc-and-packaging-line-manager)

1.  [Actions Required of Prospective Package
    Users](#actions-required-of-prospective-package-users)

2.  [How to Become an Authorized User of a Currently Certified
    Package](#How_to_Be_Authorized_Package_User)

3.  [Process for Qualifying Tritium Reservoirs for Packaging and
    Shipping in the H1616-1 and the H1616-2 Without
    Getter](#Process_for_Qualifying_Reservoirs)

4.  [Process for Getting Authorization to Package and Ship Unqualified
    or Suspect Tritium Reservoirs in the H1616-2 With
    Getter](#Authorization_to_ship_Unqualified_Reserv)

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2.  [Process Options for Packages Not Currently
    Certified](#Process_for_Pkgs_Not_Currently_Certified)

3.  [Applying for and Processing Recertification and/or Mofification
    Applications for NNSA Previously Certified Type B
    Packages](#Applying_for_Recert_or_Mod_Applications)

    1.  [Process for Applying and Processing Applications for Returning
        Previously Certified Type B Packages to
        Service](#Applying_for_Return_to_Service)

    2.  [Process for Applying for and Processing Applications for
        Recertifying Currently Certified Type B Packages with no
        Modifications](#Applying_for_Recert_With_No_Mods)

    3.  [Process for Applying for and Processing Applications for Adding
        New Content to a NNSA Currently Certified Type B
        Package](#Adding_new_Content)

        1.  [Process Description Listed in Process
            Sequence](#Adding_New_Content_in_Process_Sequence)

        2.  [Process Checklists](#Process_Checklists)

> [Applicant's Checklist](#Adding_New_Contents_Applicants_Checklist)
>
> [Line Management's Checklist](#Adding_New_Content_Line_Mgts_Checklist)
>
> [SARP Owner's Checklist](#Adding_New_Content_SARP_Owners_Checklist)
>
> [Other Prospective Package User's
> Checklist](#Adding_New_Content_Other_Users_Checklist)
>
> [Office of Deputy Administrator for Defense Program's
> Checklist](#Adding_New_Content_DADP_Checklist)
>
> [PCD's Checklist](#Adding_New_Content_PCD_Checklist)
>
> [Certifying Official's
> Checklist](#Adding_New_Content_Cert_Officials_Checkl)
>
> [Federal Site Manager's
> Checklist](#Adding_New_Content_Fed_Site_MGR_Checklis)
>
> 3.5.3.4 [Process for Applying for and Processing Recertification
> Applications for Currently Certified Type B Packages with Significant
> Changes](#Apply_for_Recert_W_Sig_Design_Changes)

4.  [Nuclear Weapon Program Special Assemblies Containing Type B
    Quantity RAM](#NELAs_Containing_Type_B_RAM)

5.  [Type B Packages Certified Under DOE
    CofCs](#Type_B_Packages_Certified_Under_CofCs)

6.  [Type B Packages Certified Under NRC or IAEA/DOT CofCA Transported
    in TSS](#Packages_Certified_by_NRC_IAEA_DOT)

7.  [Type B Package Certified by UK MOD Transported in
    TSS](#MOD_UK_Certified)

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5.  [Revocation of Authorization to Use Type B
    Package](#revocation-of-authorization-to-use-type-b-package)

6.  [Authorization of Shipping
    Conveyance](#authorization-of-shipping-conveyances)

7.  [Identification and Control of
    Items](#identification-and-control-of-items)

8.  [Handling, Storing and Shipping](#handling-storing-and-shipping)

9.  [Control of Engineered Items](#control-of-engineered-items)

10. [Control of Commercially Procured
    Items](#Control_of_Commercially_Procured_Items)

11. [As Low As Reasonably Achievable
    (ALARA)](#as-low-as-reasonably-achievable-alara)

12. [Packaging Design Control](#Packaging_Design_Control)

13. [Procurement](#Procurement)

14. [Inspection and Acceptance
    Testing](#Inspection_and_Acceptance_Testing)

15. [Computer Software Control](#computer-software-control)

[**Appendix A**](#appendix-a)

**Guide for Reviewing SARPs and TSRAs and Performing Confirmatory
Analysis**

1.  [Introduction](#Appendix_A_Introduction)

2.  [Guidance for Reviewing SARPs and
    TSRAs](#Appendix_A_Reviewing_SARPs_TSRAs)

3.  [SARP/TSRA Review Process and
    Timelines](#sarp-and-tsra-review-process-and-timelines)

    1.  [SARP and TSRA Review Process and Timelines for Initial
        Certification/Authorization](#review-process-and-timelines-for-initial-certification-of-a-type-b-package-and-for-certifying-a-nnsa-currently-certified-type-b-package-with-new-contents-and-for-the-initial-issuance-of-an-ota-based-on-a-tsra)

    2.  [SARP and TSRA Review Process and Timelines for
        recertification/reauthorization](#Timelines_for_recert_reauthorization)

4.  [HAR Submission Schedule and Review
    Timelines](#Appendix_A_HAR_Timelines)

5.  [Guidance for Performing SARP Confirmatory
    Analysis](#guidance-for-performing-sarp-confirmatory-analysis)

6.  [Guidance for Performing TSRA Confirmatory
    Analysis](#guidance-for-performing-tsra-confirmatory-analysis)

[**Appendix B**](#appendix-b)

**Guide for Developing SARPs, SRs, TSRAs and HARs**

1.  [Introduction](#Appendix_B_Intro)

2.  [Guide for Developing SARPs/SARP
    Addendums](#Appendix_B_Guide_for_Developing_SARPs)

3.  [Guide for Developing Supplemental
    Reports](#Appendix_B_Developing_Supplemental_Repor)

4.  [Guide for Implementing SARP Document Control
    Measures](#guide-for-implementing-sarp-document-control-measures)

5.  [Guide for Developing TSRAs for Containers Used to Package Type B
    Quantity
    RAM](#guide-for-developing-tsras-for-containers-used-to-package-type-b-quantity-ram)

6.  [Guide for Developing TSRAs for Special Assemblies Containing Type B
    Quantity of SNM](#Appendix_B_TSRAs_for_NELAs)

7.  [Guide for Developing HARs](#Appendix_B_Guide_for_Developing_HAR)

[**Appendix C**](#Appendix_C)

**Guide for Developing SERs, OTAs and OTCs and Description of TSRP
Process**

1.  [Introduction](#Appendix_C_Introduction)

2.  [Guide for Developing SERs for Type B
    Packages](#guide-for-developing-sers-for-type-b-packages)

3.  [Guide for Developing SERs for Type A Packages and Special
    Assemblies that Contain No SNM or Less than Type B Quantity of
    SNM](#guide-for-developing-sers-for-type-a-packages-and-special)

4.  [Guide for Developing SERs for Special Assemblies that Contain Type
    B Quantity
    RAM](#guide-for-developing-sers-for-special-assemblies-that-contain)

5.  [TSRP Process](#tsrp-process)

6.  [Guidance for Developing OTAs and
    OTCs](#Appendix_C_Developing_OTAs_and_OTCs)

[**Appendix D**](#appendix-d)

**PCD Surveillance Process**

1.  [Introduction](#Appendix_D_Intro)

2.  [Surveillance Process](#Appendix_D_Surveillance_Process)

[**Appendix E**](#appendix-e)

**PCD Web Page**

1.  [Introduction](#Appendix_E_Intro)

2.  [Web Page Master
    Responsibilities](#Appendix_E_Web_Master_Responsibilities)

3.  [Modifying Data on Web Page](#Appendix_E_Modifying_data_on_Web_Page)

    1.  [Linking Certified Container Designator in OTC File (table) to
        File that Contains Container
        Information](#Appendix_E_Container_Designator)

4.  [CE Responsibilities](#Appendix_E_CE_Responsibilities)

5.  [Web Page Users Services and
    Responsibilities](#Appendix_E_Users_ServiceResponsibilities)

[**Appendix F**](#appendix-f)

**Guide for Developing A Scope of Work and for Developing the Support**

**Contractor's Monthly Reports**

1.  [Introduction](#Appendix_F_Intro)

2.  [Scope of Work (SOW) Outline](#Appendix_F_Scope_of_Work)

3.  [Support Contractor's Monthly Report
    Outline](#Appendix_F_Support_Contractor_Monthly_Rp)

[**Appendix G**](#appendix-g)

**DOE/NNSA** **PCD Quality Assurance Program Plan**

1.  Introduction

    1.  [Purpose](#Appendix_G_Purpose)

    2.  [Scope](#Appendix_G_Scope)

    3.  [Graded Approach](#Appendix_G_Graded_Approach)

    4.  [Integrated Safety Management (ISM)
        Relationship](#Appendix_G_Integrated_Safety_Management)

2.  Quality Assurance Program

    1.  [Quality Policy](#Appendix_G_Quality_Policy)

    2.  [Program](#Appendix_G_QA_Program)

    3.  [Responsibilities](#Appendix_G_QA_Responsibilities)

3.  Personnel Training and Qualifications

    1.  [Introduction](#Appendix_G_TQ_Intro)

    2.  [Responsibilities](#Appendix_G_TQ_Responsibilities)

    3.  [Qualification of
        Personnel](#Appendix_G_TQ_Qualification_of_Personnel)

    4.  [Training](#Appendix_G_TQ_Training)

    5.  [Reading File](#Appendix_G_TQ_Reading_File)

    6.  [Records](#Appendix_G_TQ_Records)

4.  Program Improvement

    1.  [Introduction](#Appendix_G_Program_Improvement_Intro)

    2.  [Activities](#Appendix_G_Program_Improvement_Activity)

5.  Documentation and Records

    1.  [Introduction](#Appendix_G_Documentation_Records_Intro)

    2.  [Documents](#Appendix_G_Documents)

    3.  [Records Maintenance Measures](#records-maintenance-measures)

6.  Work Processes

    1.  [Introduction](#Appendix_G_Work_Processes_Intro)

    2.  [Management
        Responsibility](#Appendix_G_Work_Processes_Mgt_Responsibi)

7.  [Design Control](#design-control)

8.  [Procurement](#procurement)

9.  [Inspection and Inspection
    Testing](#inspection-and-acceptance-testing)

10. [Appraisals](#appraisals)

11. [DOE/NNSA PCD Independent
    Surveillances](#doennsa-pcd-independent-surveillances)

[**Appendix H**](#appendix-h)

[**Acronyms and Definitions**](#acronyms-and-definitions-1)

[**Appendix I**](#appendix-i)

[**References**](#references-1)

**FOREWORD**

**\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_**

The purpose of this safety guide is to establish and disseminate
standardized Department of Energy (DOE)/National Nuclear Security
Administration (NNSA) processes for establishing and maintaining
packaging programs that ensure that off-site shipments of nuclear weapon
components, Category I and II special nuclear materials (SNM), nuclear
weapon program special assemblies (SAs), and other materials of national
security interest are safe, comply with the applicable federal
regulatory and DOE Order 461.1A requirements, and present no undue risk
to the public, worker safety and health, or the environment.

Comments (recommendations, proposed additions or deletions, or any other
suggested improvements) should be sent to:

U.S. Department of Energy/ National Nuclear Security Administration

Service Center

Packaging Certification Division

Attention: Manager

P.O. Box 5400

Albuquerque, NM 87185-5400

# SECTION 1.0 {#section-1.0 .unnumbered}

# GENERAL OVERVIEW {#general-overview .unnumbered}

###  {#section .TextBold .unnumbered}

The United States Government in cooperation with other countries,
regulates the design and certification of packaging used in the
transport of hazardous materials with a special emphasis on radioactive
material (RAM). The U.S. Department of Transportation (DOT), in *Title
49 Code of Federal Regulations (CFR) Part 173* (49 CFR 173) grants the
U.S. Department of Energy the authority to certify packagings used for
transporting Class 7 materials. More specifically, 49 CFR 73(d) states
the following: "Notwithstanding the requirements of §§ 173.416 and
173.417 of this subchapter, packagings made by or under the direction of
the U.S. Department of Energy may be used for the transportation of
Class 7 materials when evaluated, approved and certified by the
Department of Energy against packaging standards equivalent to those
specified in 10 CFR part 71. Packages shipped in accordance with this
paragraph shall be marked and otherwise prepared for shipment in a
manner equivalent to that required by this subchapter for packagings
approved by the Nuclear Regulatory Commission."

Neither 49 CFR nor 10 CFR 71 impose specific requirements on structural
components in terms of allowable stress or limits on permissible
deformation. Nevertheless, it is well understood that a packaging's
containment boundary may be compromised if the structure components are
overstressed or grossly distorted, and could negatively impact the
packaging's ability to remain within regulatory limits for containment
of hazards, radiation protection and protection from criticality events.
Therefore, it is essential that structural components be designed in
accordance with a well-established design standard.

The Nuclear Regulatory Commission (NRC), in order to meet its regulatory
responsibilities, adopted the philosophy of applying strict requirements
and high margins of safety to packages used to transport significant
quantities of RAM, and has therefore developed numerous regulatory
guides to establish guidance for the design criteria for shipping casks
used to package and ship radioactive materials. NRC Regulatory Guides
7.6, *Design Criteria for the Structural Analysis of Shipping Casks
Containment Vessels* and 7.11, *Fracture Toughness Criteria of Ease
Material for Ferritic Steel Shipping Cask Containment Vessels with a
Maximum Wall Thickness of 4 Inches (0.1 m)* are two of those guides.

Regulatory Guide 7.6 recommends that structural components be designed
in accordance with the American Society of Mechanical Engineers (ASME)
Code. Regulatory Guide 7.6 also describes the design criteria for the
structural analysis of shipping cask containment vessels and explains
the use of the "design-analysis" approach for Class I components from
Section III of the ASME Code as a design criteria for the containment
vessels. Other codes and standards can be used as design criteria
provided that they can be justified to be as conservative as the ASME
Code.

Regulatory Guide 7.11 Section 2.2 recommends that the structural design
of all shielding structures be in accordance with the criteria contained
in the ASME Boiler and Pressure Vessel Code. Regulatory Guide 7.11 also
defines three categories of Type B packages based on the activity levels
of the contents. For a specific radio-isotope or combination of
radio-isotopes, Category I includes the highest levels of hazards and
therefore requires packaging designs with the highest margin of safety,
whereas Categories II and III include the medium to low activity levels
and therefore require packaging designs with lower margins of safety.

The DOE/NNSA has assigned the DOE/NNSA Service Center's Certifying
Official and Packaging Certification Division (PCD) the overall
responsibility for certifying Type B packages, and assessing the safety,
and when appropriate, authorizing shipments of nuclear weapon program
special assemblies or other materials of national security interest
transported in the Transportation Safeguards System (TSS), or other
vehicles approved by the Assistant Deputy Administrator for Secure
Transport. The TSS is managed and operated by the Office of Secure
Transportation (OST). Refer to DOE Order 461.1A for additional
information on this subject.

The DOE/NNSA PCD maintains a program and corresponding management system
for certifying Type B packages and for reviewing applications and
associated Transportation System Risk Assessments (TSRAs)/Hazards
Assessment Reports (HARs) for authorizations to ship special assemblies
and other materials of national security interest off-site. The DOE/NNSA
PCD's program and management system is based on the requirements
contained in 10 CFR 71, 49 CFR 100-185, DOE Order 461.1A, and applicable
ASME, American National Standards Institute (ANSI) and American Society
for Testing and Materials (ASTM) national standards, and the guidance
contained in the NRC Regulatory Guides. The processes and
responsibilities delineated in this guide are based on these regulatory
requirements and guides, and industry standards, and their effectiveness
has been proven through years of successful implementation.

Applicants/users who choose to deviate from the responsibilities and
processes provided in this guide do so at the risk of not having a
certified package, and/or offsite shipment authorization in time to
support their needs, or not being authorized to use a currently
certified package.

Requests for authorizations for off-site shipments that meet the 10 CFR
71 and 49 CFR 100-185 requirements must be supported by a safety
analysis report for packaging (SARP) that is prepared and submitted by
the applicant to the DOE/NNSA PCD for review and approval via the
appropriate contractor and DOE/NNSA line management chain. The safety of
the associated operations shall be documented in a safety evaluation
report (SER) that is prepared by the PCD, and the authorization, if
approved by the DOE/NNSA Certifying Official, is granted via an Offsite
Transportation Certificate (OTC).

Requests for authorizations for off-site shipments of packages that
contain Type B quantity of RAM, but which cannot be shown to meet all of
the 10 CFR 71 performance requirements must be supported by SARPs and
TSRAs.

Requests for authorizations for off-site shipments of packages that
contain Type B quantity of RAM, but cannot be shown to meet the 49 CFR
and/or 10 CFR and/or DOE Order 461.1A requirements must be supported by
SARPs and TSRAs, and must include requests, that are addressed to the
DOE/NNSA Deputy Administrator for Defense Programs (NA-10), for an
exemption from the requirements of DOE Order 461.1A.

Requests for authorization for off-site shipments of nuclear weapon
special assemblies that contain a Type B quantity of RAM, but cannot be
shown to meet the 49 CFR and/or 10 CFR requirements must be supported by
TSRAs. Requests for authorizations for off-site shipment of nuclear
weapon special assemblies that contain a Type A quantity of RAM, or
contain no RAM but contain other hazardous material; or contain no
hazardous material but must be shipped in the TSS due to security
reasons, must be supported by hazards assessment reports (HARs). The
TSRA/HAR must be prepared by the applicant and must be submitted to PCD
for review and approval via the appropriate contractor and DOE/NNSA line
management chain. The safety of the associated operations shall be
documented in a SER that is prepared by PCD, and the authorization, if
approved by the DOE/NNSA Certifying Official, is granted via an Offsite
Transportation Authorization (OTA).

The safety guide is intended to serve those subject to DOE Order 461.1A.
The safety guide is also intended as an operations manual that is
consistent with both DOT 49 CFR 173 and NRC 10 CFR 71 requirements, and
to emphasize the DOE/NNSA PCD requirement for contractors to develop and
maintain a formal approved Quality Assurance Program Plan (QAPP) for
packaging RAM.

Appendix G of this guide satisfies the 10 CFR 71 Subpart H and 10 CFR
830.120 requirements for a DOE/NNSA PCD QAPP. This guide fully complies
with the requirements of a DOE Integrated Safety Management System as
required in DOE Policy P 450.4.

The safety guide is a living document and will continue to be updated as
new processes and/or technologies are developed and as management
systems change. This safety guide does not address on-site transfers of
RAM, which are covered by DOE M 461.1A-1. In addition, this safety guide
does not address accident response activities covered by 10 CFR 830.

The provisions of this safety guide should not be construed as
contractual requirements in any audit or appraisal for compliance with
DOE Order 461.1A unless such provisions are specified by laws, federal
regulations (10 CFR 71, 10 CFR 830, and 49 CFR 100-185), or other
"requirements" documents such as DOE Directives, Orders, etc.

# RESPONSIBILITIES {#responsibilities .unnumbered}

1.  []{#Responsibilities_Introduction .anchor}**Introduction**

The DOE/NNSA PCD management retains the primary responsibility for the
scope and implementation of the DOE/NNSA Service Center's Package
Certification and Offsite Transportation Authorization Program including
quality assurance related activities. The sites and organizations that
use the products and/or services of this program are responsible for
complying with the requirements of this program and with achieving
quality in the activities for which they are responsible.

2.  []{#Responsibilities_Responsibilities .anchor}**Responsibilities**

This section delineates the responsibilities of each of the principals
involved in the DOE/NNSA package certification, and offsite
transportation authorization use and associated processes. The
responsibilities are based on the requirements contained in 10 CFR 71,
49 CFR 100-185, DOE Order 461.1A, and ASME, ANSI, and ASTM national
standards, and the guidance contained in NRC Regulatory Guides.

Applicants/users who choose to deviate from the responsibilities
delineated below do so at the peril of not having a certified package,
and/or offsite transportation authorization in time to support their
needs, or not being authorized to use a currently certified package.

1.  []{#Responsibilities_HQ .anchor}**DOE/NNSA Headquarters**

Refer to DOE Order 461.1A.

2.  []{#Responsibilities_Certifying_official .anchor}**DOE/NNSA
    Certifying Official**

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A.  **Budget**

    1.  Ensures that the DOE/NNSA PCD has the staff and resources to
        continue to perform assigned Type B package certification and
        off-site transportation authorization functions.

    2.  Works with funding sources to ensure that the PCD is allocated
        the resources needed to fund the SARP and TSRA reviews, maintain
        program guides, conduct staff training, and perform official
        travel.

B.  []{#Certifying_Official_Subsection_B .anchor}**Package Certification
    and Shipment Authorization**

    1.  Certifies Type B Package by approving an OTC and returning the
        signed OTC and the SER to the PCD Manager for distribution.

    2.  Authorizes off-site shipment of special assembly or other
        material of national security interest by approving the OTA and
        returning the signed OTA and SER to the PCD Manager for
        distribution.

    3.  Forwards requests for exemptions to DOE Order 461.1A to the
        DOE/NNSA Deputy Administrator for Defense Programs (NA-10) with
        recommendations for approval/disapproval via management chain.

    4.  Approves/disapproves a OTC/OTA, SER and distribution memorandum
        associated with a NA-10 exemption by signing the OTC/OTA and
        distribution memorandum.

    5.  If OTC, OTA, SER and/or distribution memorandum are disapproved,
        identifies the reason(s) for the disapproval and instructs the
        PCD on how to proceed.

    6.  Reviews the PCD Manager's recommendations to decertify a
        currently certified package and take action as needed. For
        example:

> [Option 1:]{.underline} approve PCD's recommendation, brief/notify
> senior DOE/NNSA management of planned action, and sign a letter that
> is prepared by the PCD staff to notify the Nuclear Weapons Complex
> that the package has been decertified and must not be used under the
> specified SARP(s), SER(s), OTC(s) and/or OTA(s) until further notice.
> The letter should also specify that the applicable Packaging Line
> Manager should submit a recovery plan, via the Packaging Line
> Manager's management chain, to the Certifying Official for review and
> approval prior to proceeding with proposed corrective actions.
>
> [Option 2:]{.underline} disapprove PCD Manager's recommendation and
> instruct the PCD to re-review package and recommendations and revise
> proposed recommendations as needed and resubmit for reconsideration,
> if required.

7.  Reviews documentation and recommendations provided by the PCD to
    terminate a user's use of a specified OTC/OTA based on the user's
    noncompliance and/or violations of the SARP, and/or OTC/OTA, and
    take action as needed. For example: approve the PCD's
    recommendation, brief/notify upper management of planned action, and
    sign a letter that is prepared by the PCD staff to notify the
    subject user, DOE/NNSA management, DOE/NNSA Site Manager, and the
    applicable Packaging Line Manager/Weapon System Program Manager that
    the subject user is prohibited from using the authority granted in
    the specified OTC/OTA until further notice. The letter should also
    specify that a recovery plan must be submitted, via the user's
    management chain, to the Certifying Official for review and approval
    prior to proceeding with proposed corrective actions.

**2.2.3** []{#Responsibilities_PCD_Manager .anchor}**PCD Manager**

A.  **Budget**

    1.  Works with Certifying Official and funding sources to ensure
        that the PCD is allocated the resources needed to fund the SARP
        and TSRA reviews, maintain program guides, conduct staff
        training, and perform official travel.

    2.  Develops, maintains, and submits budget projections to DOE/NNSA
        Headquarters via applicable management chain.

    3.  Manages PCD budget.

    4.  Maintains records of allocations and expenditures.

B.  **Program Management**

    1.  Establishes and maintains PCD position descriptions and team
        composition to ensure that the staff can perform all of the
        program's assigned functions.

    2.  Makes PCD team member candidate selection, when applicable.

    3.  Establishes work assignment priorities, assigns resources,
        monitors work and makes adjustments as required based on
        schedule demands, funding availability, and other considerations
        as appropriate.

    4.  Appoints PCD Web Page Master and Alternate.

    5.  Establishes and maintains a viable Lessons Learned Workshop
        program. Conduct periodic workshops to review the Program
        status, improve the working relations between the Transportation
        Safety Review Panel (TSRP) members and applicant's staff,
        incorporate lessons learned, improve the processes, increase
        efficiency, and ensure that the Program requirements and
        processes are appropriate and do not become unnecessarily
        cumbersome.

    6.  Appoints an Acting Manager during his/her absence of one day or
        more, and notifies management and customers of his/her absence
        by providing the name of the Acting Manager, the period for the
        appointment, and information on how he/she can be contacted.

    7.  Implements and complies with the guidance specified in [Section
        3.0](#section-3.0), *Programs and Processes*.

C.  **Training**

    1.  Completes and maintains qualification through the PCD Manager's
        Technical-Qualification Standard (TQS).

    2.  Establishes and maintains PCD Manager's and Package
        Certification Engineer's (CE's) TQS and oversees/manages team
        members' TQS training and qualifications.

    3.  Ensures that the CEs are trained on the TSS's capacity,
        restraint hardware and general systems limitations.

D.  **Support of Others**

    1.  Provides technical assistance/advice to DOE/NNSA Headquarters,
        DOE/NNSA Certifying Official, Site management, Package Line
        Managers, Weapon System Program Managers and OST when required.

    2.  Assigns CEs that have undergone training on the TSS's capacity,
        restraint hardware and general systems limitations as liaisons
        between OST and PCD staffs, if the need arises.

    3.  Works with Package Line Managers, Site managers and Weapon
        System Program Managers to ensure that they understand their
        responsibilities, and why their roles in the success of the
        package certification and off-site transportation authorization
        program are critical to the success of their programs.

E.  []{#PCD_Mgr_Pkg_Cert_and_Ship_Authoriz_respo .anchor}**Package
    Certification and Shipment Authorizations**

    1.  Assigns TSRP Chairman to lead SARP and TSRA reviews, and
        Packaging Project Lead Certification Engineer to lead HAR
        reviews and/or other projects.

    2.  Appoints Technical Advisor to support SARP and/or TSRA
        development team, if resources allow.

    3.  Assigns/allocates resources to TSRP Chairman, HAR review leader,
        and TSRA technical advisor.

    4.  Reviews and approves comments (Qs) developed during SARP and
        TSRA reviews and forward them to the applicant via applicable
        DOE/NNSA line management (Site management, Package Line Managers
        or Weapon System Program Manager, as applicable).

    5.  Reviews TSRP Chairman's and HAR review leader's recommendation
        for approving SARP, TSRA or HAR or for terminating the review
        and informing the applicant and the DOE/NNSA line management
        (Site's management, Package Line Managers and/or Weapon System
        Program Manager, as applicable).

    6.  Reviews SER, OTC or OTA, and associated distribution for
        completeness and correctness.

    7.  Returns SER, OTA or OTC and associated distribution memorandum
        to the TSRP Chairman or HAR review leader for rework, or
        forwards to the DOE/NNSA Certifying Official with recommendation
        for approval.

    8.  Forwards signed OTAs/OTCs and SER to the CEs for distribution.

    9.  Forwards requests for exemptions to DOE Order 461.1A to the
        DOE/NNSA Certifying Official with recommendations for the
        DOE/NNSA Deputy Administrator for Defense Programs to
        approve/disapprove.

    10. Reviews information on OTA/OTC user's noncompliance with SARP,
        and/or OTA/OTC requirements and takes appropriate action. See
        PCD Manager Oversight Section for additional information. The
        following are examples of actions that could be taken:

        a.  Review documentation of the OTA/OTC user's acts of
            noncompliance. Review, and if applicable approve, CE
            developed recommended action(s) and present to the DOE/NNSA
            Certifying Official. Review and if appropriate forward the
            letter that is prepared by the CE for the DOE/NNSA
            Certifying Official's signature. The letter shall notify the
            subject user, DOE/NNSA management, DOE/NNSA Site Manager,
            and the applicable Packaging Line Manager/Weapon System
            Program Manager that the subject user is prohibited from
            using the authority granted in the specified OTA/OTC until
            further notice. The letter should also specify that a
            recovery plan must be submitted, via the user's management
            chain, to the DOE/NNSA Certifying Official for review and
            approval prior to proceeding with proposed corrective
            actions.

        b.  Staff a surveillance team and conduct a surveillance visit
            of the OTA/OTC user and tasks the team to develop a
            recommended course of action. Present the surveillance
            team's recommended course of action to the DOE/NNSA
            Certifying Official and take action(s) as directed by the
            DOE/NNSA Certifying Official. Refer to Appendix D for
            guidance on surveillance process.

11\. Reviews all reports or evidence concerning any currently certified
Type-B package that may indicate that the package may not meet the
applicable regulatory requirements (i.e., the regulatory requirements
that were applicable when the package was first designed and certified
and new regulatory requirements that have been specified for the package
type since its original certification) and take the appropriate action.
For example:

a.  Develop recommended package certification course of action (continue
    the package's certification or decertify the package) and provide to
    the DOE/NNSA Certifying Official for his/her approval. Review and if
    applicable forward the CE prepared letter to the DOE/NNSA Certifying
    Official.

b.  Recommend that Packaging Line Manager task the SARP and package
    owners to perform a review of the issues and to develop a
    recommended course of action.

c.  Task a CE or TSRP to conduct a review and provide a recommended
    package certification course of action (continue the package's
    certification or decertify the package).

d.  For proposed actions that involve the termination/suspension of a
    currently certified package' certification, task the CE to prepare a
    letter for the DOE/NNSA Certifying Official's signature. The letter
    shall notify the Nuclear Weapons Complex that the package has been
    decertified and must not be used under the specified SARP, OTC
    and/or OTA until further notice. The letter should also specify that
    the applicable Packaging Line Manager should submit a recovery plan,
    via the Packaging Line Manager's management chain, to the Certifying
    Official for review and approval prior to proceeding with proposed
    corrective actions.

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F.  **Management of Technical Support Contractor**

    1.  Tasks, provides oversight and manage Technical Support
        Contractor(s).

    2.  Funds Technical Support Contractor(s) activities.

    3.  Develops work plan and work scope and budget as a "Work For
        Others" work transfer for on-call technical support. Refer to
        Appendix F for guidance on developing a Scope of Work.

    4.  Develops Work Scope for Package Certification support (Work For
        Others) technical subject matter experts (SMEs) that perform
        SARP/TSRA reviews and associated confirmatory analysis
        (Structural, Thermal, Shielding, Criticality, quality assurance
        (QA), etc. -- NRC NUREG-1609/Regulatory Guide 7.9) and selects
        providers using the following criteria:

        a.  Availability and affordability of national laboratory and
            contractor resource for providing technical support.

        b.  Record of leadership and performance.

        c.  Qualifications of prospective technical SMEs and their
            compatibility with TSRP needs. The TSRP must be composed of
            members that are technically competent to review the
            adequacy and correctness of each of the SARP sections
            recommended in NRC NUREG-1609/Regulatory Guide 7.9 and that
            are technically competent to review the adequacy and
            correctness of TSRAs. Refer to Appendix A for information on
            SARP and TSRA reviews.

        d.  Ability to develop and implement work plans and procedures
            for performing SARP/TSRA reviews and confirmatory analysis,
            and maintaining prescribed schedule. Refer to Appendix A for
            additional information on performing confirmatory analysis.

        e.  Ability to demonstrate that there is no conflict of
            interest. The technical support contractor must provide
            assurance to DOE/NNSA PCD that they can staff the team
            leader and SMEs positions with qualified staff members that
            have not provided direction or technical input nor
            participated in any procurement and/or development
            activities for the package to be evaluated prior to
            initiating any SARP/TSRA review activities.

        f.  Ability to document and clearly communicate the results of
            the SARP/TSRA review.

        g.  Ability to manage a program to ensure that it stays on
            schedule and within budget.

        h.  Ability to develop and provide monthly expenditure and
            activity reports for each of the assigned tasks to DOE/NNSA
            PCD.

        i.  Ability for maintaining auditable records of the work
            performed in support of the DOE/NNSA package certification
            and offsite authorization program.

5\. Periodically reviews the capabilities and affordability of the
technical support contractor(s) used to supplement SARP and/or TSRA
reviews and to perform confirmatory analysis and other available
contractor sources available for these tasks to ensure that the
contractor used is technically competent and cost effective. One of the
principal goals of this process is to ensure the availability of
technically competent and affordable on-call technical support that can
provide technically correct and timely products in response to tasks.

G.  **Oversight**

    1.  Provides appropriate oversight of OTA/OTC user activities.

    2.  Supports DOE/NNSA Headquarters in their appraisal/oversight
        function by providing members for appraisal/oversight teams.

    3.  Appoints surveillance team and team leader to conduct
        surveillance of OTA/OTC user activities, as required. Refer to
        Appendix D for information on surveillance process.

    4.  Provides the surveillance team's findings and recommendations to
        the DOE/NNSA Certifying Official.

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    1.  []{#Responsibilities_CEs .anchor}**PCD Certification Engineers
        (CEs)**

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A.  **Program Management**

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1.  Perform the functions of Acting PCD Manager, when assigned.

2.  Implement and comply with the guidance specified in [Section
    3.0](#section-3.0), *Programs and Processes*.

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B.  []{#CE_Pkg_Cert_and_Ship_Authoriz_responsibi .anchor}**Package
    Certification and Shipment Authorizations**

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1.  Lead and manage SARP, TSRA and HAR reviews, and/or other tasks as
    assigned.

2.  Review all reports or evidence, concerning currently certified
    Type-B packages under their cognizance and/or other packages as
    assigned, that may indicate that the package may not meet the
    applicable regulatory requirements (i.e., the regulatory
    requirements that were applicable when the package was first
    designed and certified and new regulatory requirements that have
    been specified for the package type since its original
    certification). Develop action plan that is commensurate with the
    level of the review, lead and/or perform the review, and prepare the
    resultant documents and recommendations and provide them to the PCD
    Manager on a predetermined schedule. Prepare a letter for the
    DOE/NNSA Certifying Official's signature that shall notify the
    Nuclear Weapons Complex that the package has been decertified and
    must not be used under the specified SARP(s), OTC(s) and/or OTA(s)
    until further notice. The letter should also specify that the
    applicable Packaging Line Manager should submit a recovery plan, via
    the Packaging Line Manager's management chain, to the DOE/NNSA
    Certifying Official for review and approval prior to proceeding with
    proposed corrective actions.

3.  Review information on OTA/OTC user's noncompliance with SARP, and/or
    OTA/OTC requirements and prepare a brief/document that addresses the
    issues and provides a proposed recommended course of action, and
    provide it to the PCD Manager. Prepare a letter, for the DOE/NNSA
    Certifying Official's signature, that notifies the subject user,
    DOE/NNSA management, DOE/NNSA Site Manager, and the applicable
    Packaging Line Manager/Weapon System Program Manager that the
    subject user is prohibited from using the authority granted in the
    specified OTA/OTA until further notice. The letter should also
    specify that a recovery plan must be submitted, via the user's
    management chain, to the DOE/NNSA Certifying Official for review and
    approval prior to proceeding with proposed corrective actions.

4.  Perform the following SARP, TSRA and HAR functions:

> a\. TSRP Chairman must:

1.  Assist the PCD Manager in developing documents for tasking the
    Technical Support Contractor that will perform the SARP and/or TSRA
    review and associated confirmatory analysis, and/or other technical
    reviews.

2.  Lead the TSRP's review of the SARP/TSRA.

3.  Provide distribution list for draft SARP and/or TSRA to applicant.

4.  Convene the TSRP to evaluate the SARP/TSRA upon receipt of the
    SARP/TSRA from the PCD Manager.

5.  Chair TSRP-applicant comment review meeting.

6.  Document Qs developed during the review and submit the Qs and
    distribution memorandum to the PCD Manager.

7.  Review applicant's responses to the Qs and:

    a.  Recommend closure of Qs to the PCD Manager, if applicable.

    b.  Develop and submit Qs that address issues that remain open or
        new Qs in response to applicant's responses, if applicable.

    c.  Submit open/new Qs and associated distribution memorandum to PCD
        Manager.

> \(8\) Recommend approval of SARP/TSRA after all Qs have been resolved
> satisfactorily, or recommend termination of review if Qs cannot be
> resolved.
>
> b\. CEs who lead HAR reviews must:

1.  Review HAR and document Qs developed during the review and provide
    to the applicant and the applicable Weapon System Program Manager.

2.  Approve applicant's responses to Qs, or if unable to come to closure
    on the Qs, recommend termination of the review to the PCD Manager.

3.  Prepare correspondence, for the PCD Manager's signature, to
    officially advise the applicant and the Weapon System Program
    Manager of the decision to terminate the review, when required.

> c\. []{#CE_Review_of_PkgProcedures_and_QA_Plan .anchor}CEs that chair
> TSRPs or lead HAR reviews must:

1.  Review and approve or disapprove and provide review comments for
    resolution to the prospective package users on their draft
    package-specific packaging procedures for items packaged and shipped
    in certified containers, and the associated Site quality assurance
    plan. If unable to approve a prospective user's packaging procedures
    and/or Site quality assurance plan, due to irresolvable
    deficiencies, the issue will be briefed to the DOE/NNSA Certifying
    Official and the DOE/NNSA Service Center's management. The
    prospective user shall not be designated an authorized user of the
    package and the prospective user will be prohibited from using the
    package until the packaging procedures and Site quality assurance
    plan have been approved. If the prospective user disagrees with the
    DOE/NNSA Service Center's decision to not approve the prospective
    user's draft packaging procedures, the prospective user is free to
    appeal this decision, with appropriate technical justification, to
    upper DOE/NNSA management.

2.  Ensure that the documentation submitted for items shipped in
    handling gear lists the approved handling gear for that item.

3.  Develop SER in accordance with the format provide in Appendix C.

4.  []{#CE_SER_OTC_OTA_Prep .anchor}Provide SER and associated OTC/OTA
    and distribution memorandum to PCD Manager. If applicable, lead the
    effort to resolve the issues that led to the DOE/NNSA Certifying
    Official disapprove the OTC/OTA, SER or distribution memorandum, and
    if necessary rewrite and resubmit the documents for approval. The
    probability of this occurring in not very high since the PCD will
    have kept the DOE/NNSA Certifying Official informed of all possible
    problems as the project progressed.

5.  Ensure that copies of approved OTAs/OTCs and SERs are distributed to
    the applicant and other NNSA-approved users, and the Office of
    Secure Transportation.

6.  Maintain OTA/OTC, SARP, TSRA, HARs and associated records.

7.  Provide timely and accurate information to update PCD Web Page to
    the Web Page Master. Refer to [Appendix E](#appendix-e) for
    information on Web Page content.

> d\. SARP/TSRA Technical Advisor must:

(1) Provide technical advice to applicable line manager/Weapon System
    Manager responsible for overseeing SARP/TSRA development.

(2) Attend, support and participate in SARP and TSRA related meeting, as
    needed.

(3) Attend, support and participate in TSRA kick-off meeting, as
    required.

(4) Keep PCD Manager advised of SARP/TSRA support activities.

(5) Maintain SARP/TSRA Technical Advisor records.

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C.  **Assistance to OST Staff**

    1.  Assist OST planning staff to properly interpret OTAs, OTCs, NRC
        and EM-5 Certificates of Compliance **(**CofCs), and other
        regulatory approval documents.

    2.  Screen all OTC and OTA requests to determine if Technical
        Publication (TP) 45-51 and/or the DOE/NNSA tiedown manuals
        contain the tiedown procedures needed to secure the package
        and/or handling gear and associated configuration proposed for
        shipment. Remind the applicant that they must submit draft
        tiedown procedures to the OST Engineering/Assurance Staff for
        those package/handling gear/configurations not covered in the TP
        45-51 or DOE tiedown manuals and notify the OST
        Engineering/Assurance Staff of the situation. Consult with OST
        Engineering/Assurance Staff when there is uncertainty as to
        whether the TSS hardware can accommodate a specified cargo
        configuration.

    3.  Supplement OST staff efforts to advise potential OST customers
        of the general limits on TSS hardware application and practical
        hazardous material (HAZMAT) and particularly radiological
        emission guidelines.

    4.  In consultation with OST, mirror maximum HAZMAT limits on mixed
        hazards and radiological exposure hazards into OTCs and OTAs.

    5.  Function as liaisons between OST and PCD staffs if the need
        arises.

D.  **Training**

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1.  Complete and maintain Package Certification Engineer qualification
    under the Package Certification Engineer's TQS.

2.  Establish and maintain familiarity with operation of the TSS trailer
    hardware and restraint systems, and TSS capabilities and
    limitations.

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E.  **Oversight**

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1.  Perform oversight of OTA/OTC activities as directed.

2.  Notify the PCD Manager of all noncompliance issues/concerns and/or
    OTA/OTC violations and provide recommended course of action.

3.  Perform surveillance visit of OTA/OTC users when directed.

    a.  Refer to [Appendix D](#appendix-d) for guidance on surveillance
        process.

    b.  Prepare surveillance report with associated recommendations, and
        submit the report to the PCD Manager.

4\. Participate on DOE/NNSA Headquarters appraisal/oversight teams when
directed.

F.  **Web Page Management**

    1.  Assist OTA/OTC Web Page Master in maintaining the Web Page by
        providing timely updates.

    2.  Perform the functions of the PCD Web Page Master and/or
        Alternate Web Page Master when assigned by updating the Web Page
        information to reflect the current status of all items addressed
        in the Web Page. See [Appendix E](#appendix-e) for information
        on PCD Web Page.

### OST {#ost .TextBold}

###  {#section-1 .TextBold .unnumbered}

1.  []{#OST_Planning_Staff .anchor}**OST Planning Staff**

###  {#section-2 .TextBold .unnumbered}

A.  Validate that the requirements outlined in OTA(s) and OTC(s) are
    consistent with the stipulations of the transportation service
    request (TSR).

B.  Address inquiries about a particular OTA or OTC to the cognizant CE.
    The cognizant CE is identified in the OTA/OTC transmittal
    memorandum.

C.  Maintain current copies of SERs, OTCs, CofCs and OTAs.

D.  Advise PCD through the cognizant CE of any notable anomalies with
    the application of the OTC or OTA during a shipment, including any
    incompatibility with TSS hardware issues.

E.  Notify the PCD when any transportation requests indicate that the
    proposed shipment does not concur with the authorized content
    specified in the applicable OTA or OTC.

### Engineering/Assurance Staff {#engineeringassurance-staff .TextBold}

###  {#section-3 .TextBold .unnumbered}

A.  Provide general training to all CEs on the TSS vehicles and
    restraint equipment, as needed.

B.  Address CE inquiries concerning use of TSS vehicles and restraint
    equipment for proposed shipment applications.

C.  Review applicant developed restraint tiedown procedures and approve
    or disapprove, as applicable, and notify the applicant and PCD in
    writing.

D.  Provide technical assistance to CEs on TSS safety and risk bases
    documents in support of transportation risk assessment activities
    performed in support of OTA requests/renewals.

    3.  []{#Federal_DOE_NNSA_Site_Line_Managers .anchor}**Federal
        DOE/NNSA Site Line Managers**

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A.  Determine Site needs for OTCs and/or OTAs and communicate the need
    to supporting organizations and PCD.

B.  Ensure that the consignor and consignee sites are authorized users
    of the Type B packages that they need to support their mission. If
    they are not authorized users, the sites must submit the applicable
    packaging procedures for review and approval by DOE/NNSA PCD, and be
    designated an approved user of the package before they can be
    allowed to use the package.

C.  Ensure that contractor(s) comply with OTA/OTC requirements, and
    report all noncompliances to the DOE/NNSA Certifying Official and
    the PCD Manager.

D.  Review recovery plans that are developed by OTA/OTC users that have
    been prohibited to use specified OTA(s)/OTC(s) by the DOE/NNSA
    Certifying Official and provide comments, as applicable.

E.  Oversee the contractor assigned to develop the SARP, TSRA and/or HAR
    and ensure that the SARP, TSRA and/or HAR are submitted in the time
    schedule prescribed.

F.  Review SARP and completed current version of the Safety Guide (SG)
    200 *SARP Completeness Review Checklist of DOE/NNSA Defense Programs
    Packages*, TSRA and/or HAR and associated OTC/OTA request to ensure
    that they are correct, complete, and accurate.

G.  Participate in TSRP-applicant SARP and/or TSRA comment review
    meeting(s), when requested by PCD.

H.  Review the Qs developed by the TSRP during the SARP/TSRA review and
    the applicant's responses to the Qs to ensure that they are correct
    and timely.

I.  Assist in issue resolution, if required.

J.  Review the Site's exemption requests to the DOE/NNSA Deputy
    Administrator for Defense Programs and provide recommendation for
    approval/disapproval to the DOE/NNSA Deputy Administrator for
    Defense Programs. If the DOE/NNSA Deputy Administrator for Defense
    Programs grants the exemption, perform the functions directed in the
    DOE/NNSA Deputy Administrator for Defense Programs correspondence
    that grants the exemption, and determine if and when the packaging
    and transportation activities addressed in the DOE/NNSA Deputy
    Administrator for Defense Programs exemption may begin.

K.  Review package specific packaging procedures to ensure that they are
    correct, complete, and accurate.

L.  Ensure Site's compliance with DOE Order 461.1A, and OTA/OTC
    requirements.

M.  Establish and maintain, and ensure that the applicable site
    contractor(s) establishes and maintains a packaging program QAPP
    that meets 10 CFR 71, Subpart H requirements.

N.  Maintain file of current OTAs and OTCs applicable to the site.

O.  Support DOE/NNSA Headquarters in their appraisal/oversight function
    by providing members for appraisal/oversight teams.

P.  Verify that that there are no outstanding appraisal findings that
    might affect a packaging/shipment operation.

Q.  Perform oversight of packaging and off-site transportation
    activities.

R.  Implement and comply with the guidance specified in [Section
    3.0](#section-3.0), *Programs and Processes*.

### DOE/NNSA Package Line Managers {#doennsa-package-line-managers .TextBold}

###  {#section-4 .TextBold .unnumbered}

A.  Oversee the contractor assigned to develop the SARP and/or TSRA and
    ensure that the SARP and/or TSRA are submitted at least nine months
    prior to the OTC/OTA need date. Refer to [Section
    3.0](#section-3.0), [Appendix A](#appendix-a) and [Appendix
    B](#appendix-b) for additional information on the associated
    processes.

B.  Review SARP and completed SG 200 *SARP Completeness Review Checklist
    of DOE/NNSA Defense Programs Packages* and/or TSRA and associated
    OTC/OTA request to ensure that they are correct, adequate, and
    accurate.

C.  Participate in and support TSRP-applicant SARP and/or TSRA comment
    review meeting(s).

D.  Review the Qs developed by the TSRP during the SARP/TSRA review and
    the applicant's responses to the Qs to ensure that the responses are
    correct and timely.

E.  Assist in issue resolution, if required.

F.  Review package specific packaging procedures to ensure that they are
    correct, adequate, and accurate.

G.  Support DOE/NNSA Headquarters in their appraisal/oversight function
    by providing members for appraisal/oversight teams.

H.  Verify that that there are no outstanding appraisal findings that
    might affect a packaging/shipment operation.

I.  Review all reports or evidence concerning any currently certified
    Type-B package that may indicate that the package may not meet the
    applicable regulatory requirements (i.e., the regulatory
    requirements that were applicable when the package was first
    designed and certified and new regulatory requirements that have
    been specified for the package type since its original
    certification) and task the SARP and package owners to perform a
    review of the issues and to develop a recommended course of action.
    Submit the results of the review and recommended course of action to
    the DOE/NNSA Certifying Official and PCD Manager. When applicable,
    develop recovery plan for packages that have been decertified by the
    DOE/NNSA Certifying Official and submit the draft recovery plan to
    the DOE/NNSA Certifying Official and the PCD Manager for review and
    approval via the appropriate management chain.

J.  Implement and comply with the guidance specified in [Section
    3.0](#section-3.0), *Programs and Processes*, of this guide.

    3.  []{#Weapon_System_Program_Manager .anchor}**Weapon System
        Program Manager**

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A.  Determine special assembly needs.

B.  Get written authorization from the senior DOE/NNSA Headquarters
    nuclear weapons program line manager who has responsibility for
    granting approval to build and test special assemblies that contain
    Type B quantity RAM prior to scheduling a build or test of a special
    assembly that contains fissile material.

C.  Determine program needs for OTAs and communicate the need to
    supporting organizations and PCD.

D.  Select, task, fund and oversee the contractor assigned to develop
    the TSRA and/or HAR.

E.  Ensure that the TSRA is submitted not less than nine months prior to
    the OTA need date, and the HAR is submitted not later than 60 days
    prior to the OTA need date. Refer to [Section 3.0](#section-3.0),
    [Appendix A](#appendix-a) and [Appendix B](#appendix-b) for
    additional information on the associated processes.

F.  Review TSRA and/or HAR and associated OTC/OTA request to ensure that
    they are correct, complete and accurate.

G.  Review the Qs developed by the TSRP during the TSRA review and the
    applicant's and/or TSRA development organization's responses to Qs
    to ensure that the applicant and/or TSRA development organization
    provides correct and timely responses.

H.  Assist in issue resolution, if required.

I.  Review recovery plans that are developed by OTA/OTC users that have
    been prohibited to use specified OTA(s)/OTC(s) by the DOE/NNSA
    Certifying Official and provide comments, as applicable.

J.  Perform the functions associated with the responsibilities assigned
    in DOE Order 461.1A.

K.  Support DOE/NNSA Headquarters in their appraisal/oversight function
    by providing members for appraisal/oversight teams.

L.  Implement and comply with the guidance specified in [Section
    3](#section-3.0), *Programs and Processes*, of this guide.

    3.  []{#SARP_Owner .anchor}**SARP Owner**

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A.  Maintain contact with DOE/NNSA PCD for requirements and guidance
    relating to packaging and transportation.

B.  Manage and maintain SARP and supporting documents.

    1.  Develop or manage (See SARP/TSRA Development Organization
        Section) the development of the SARP/SARP addendum.

    2.  Attend, support and participate in applicable SARP/SARP addendum
        related meetings, as needed.

    3.  Attend, support and participate in applicable SARP/SARP addendum
        kick-off meetings, as required.

    4.  Ensure that the SARP/SARP addendum is prepared using the formats
        and contents specified in [Appendix B](#appendix-b). Refer to
        [Section 3.0](#section-3.0) and [Appendix A](#appendix-a) for
        additional information on the associated processes.

    5.  Ensure that at least nine months prior to the OTC need date,
        copies of the draft SARP/SARP addendum are provided to the
        Package Line Manager and to the individuals on the list provided
        by PCD.

    6.  Participate in TSRP-applicant SARP/SARP addendum comment review
        meetings.

    7.  Review the Qs developed by the TSRP during the SARP/SARP
        addendum /TSRA review, and ensure that responses are developed
        and submitted on time, and are correct and appropriate to the
        Qs. Proposed changes to SARP/SARP addendum/TSRA and/or
        supporting documents must be submitted to PCD verbatim for
        review and approval before the SARP/SARP addendum /TSRA and/or
        supporting documents is changed.

    8.  Ensure that the final SARP/SARP addendum /TSRA and/or supporting
        documents are published and distributed after the changes have
        been approved by PCD.

**C.** Work with applicant to determine whether previously performed
tests, analysis and documentation support their needs, as
needed/requested.

**D.** Review proposed changes to authorized contents and provide
recommendations to PCD.

**E.** Review all reports or evidence concerning any currently certified
Type-B package that may indicate that the package may not meet the
applicable regulatory requirements (i.e., the regulatory requirements
that were applicable when the package was first designed and certified
and new regulatory requirements that have been specified for the package
type since its original certification) and develop a recommended course
of action, and provide to PCD and the Package Line Manager.

**F.** Review operational occurrence reports associated with the
certified package(s) under their cognizance, and work in consonance with
PCD to develop and implement changes/actions to prevent their
recurrence, as needed.

**H.** Implement and comply with the guidance specified in [Section
3.0](#section-3.0), *Programs and Processes*.

### Package Owner {#package-owner .TextBold}

###  {#section-5 .TextBold .unnumbered}

A.  Ensure that all required operating/refurbishment actions are
    completed and that all nonconformances identified are documented,
    evaluated, and reported to PCD.

B.  Work in consonance with PCD to resolve all nonconformances.

C.  Review all reports or evidence concerning any currently certified
    Type-B package that may indicate that the package may not meet the
    applicable regulatory requirements (i.e., the regulatory
    requirements that were applicable when the package was first
    designed and certified and new regulatory requirements that have
    been specified for the package type since its original
    certification) and develop a recommended course of action, and
    provide to PCD and the Package Line Manager.

D.  Receive package user complaints and provide responses to users and
    PCD.

E.  Ensure that the packaging's configuration is controlled and
    maintained.

F.  Implement and comply with the guidance specified in [Section
    3.0](#section-3.0), *Programs and Processes*.

### Site Approved to Perform Maintenance on DOE/NNSA Certified Packages {#site-approved-to-perform-maintenance-on-doennsa-certified-packages .TextBold}

A.  Perform authorized maintenance actions on certified packagings.

B.  Perform specified acceptance tests and all other specified
    acceptance requirements on certified packagings under their
    cognizance.

C.  Maintain fixtures for authorized contents of packagings under their
    cognizance.

D.  Warehouse spare packagings and provide packagings to users as
    needed.

E.  Track use, condition and location of packagings.

F.  Submit proposed package design and/or SARP improvements to the
    package/SARP owner, as necessary. This site should also work
    collaboratively with the package/SARP owner, and support the 5-year
    package re-certification activities by performing non-destructive
    analysis on selected packagings as directed by the package owner,
    updating applicable documents, and performing other functions, as
    needed.

G.  Implement and comply with the guidance specified in [Section
    3.0](#section-3.0), *Programs and Processes*.

###  Site Approved to Provide Packaging Supplies {#site-approved-to-provide-packaging-supplies .TextBold}

A.  Provide authorized packagings, and packaging components/consumables
    to package authorized users and sites authorized to perform
    maintenance, as applicable.

B.  Procure and perform quality acceptance of packagings and packaging
    supplies (i.e., spare parts such as O-rings, bolts, etc.).

C.  Comply with the applicable requirements of [Section
    3.0](#section-3.0) of this Guide. The requirements that are of
    particular interest to this function are contained in [Sections
    3.10](#control-of-engineered-items), Co*ntrol of Engineered Items*,
    [3.11](#Control_of_Commercially_Procured_Items), *Control of
    Commercially Procured Items*, [3.14](#Procurement), *Procurement,*
    and [3.15](#Inspection_and_Acceptance_Testing), *Inspection and
    Acceptance Testing* of this Guide.

D.  Maintain a DOE-auditable quality system that complies with the
    requirements of 10 CRF 71, Subparts G and H. The site shall maintain
    a qualified supplier list, use a graded approach for supplier
    qualification, periodically audit suppliers, track supplier
    performance, and require supplier corrective action, as necessary.
    The quality requirements for the item procured must be specified in
    the purchase order.

E.  This site may also be used for maintenance and storage of packagings
    until needed by a using site. This activity includes performing
    periodic re-certification of the packagings. Refer to [Section
    2.2.10](#site-approved-to-perform-maintenance-on-doennsa-certified-packages),
    *Site Approved to Perform Maintenance on DOE/NNSA Certified
    Packages* for additional information on this responsibility.

F.  Submit proposed package design and/or SARP improvements to the
    package/SARP owner, as necessary. This site should also work
    collaboratively with the package/SARP owner, and support the 5-year
    package re-certification activities by performing non-destructive
    analysis on selected packagings only as directed by the package
    owner, updating applicable documents, and performing other
    functions, as needed.

###   SARP/TSRA Development Organization {#sarptsra-development-organization .TextBold}

###  {#section-6 .TextBold .unnumbered}

A.  Attend, support, and participate in SARP/TSRA kick-off meeting,
    TSRP-applicant SARP and/or TSRA comment review meeting and other
    applicable SARP and TSRA related meetings, as needed.

B.  Ensure that the SARP and TSRA are prepared using the formats and
    contents specified in [Appendix B](#appendix-b). Refer to [Section
    3.0](#section-3.0) and [Appendix A](#appendix-a) for additional
    information on the associated processes.

C.  Distribute one copy of draft SARP and/or TSRA to Site Management/
    Package Line Manager/Weapon System Program Manager and four copies
    to the recipients identified by PCD. The draft SARP/TSRA must be
    submitted not later than nine months prior to the OTC/OTA need date.

D.  Review the Qs developed by the TSRP during the SARP/TSRA review, and
    develop and submit timely, correct and appropriate responses to Qs.
    Proposed changes to SARPs and/or TSRAs and/or supporting documents
    must be submitted to PCD verbatim for review and approval before the
    SARPs and/or TSRAs and/or supporting documents are changed.

E.  Publish final SARP and/or TSRA and/or supporting documents after the
    changes have been approved by PCD.

F.  Implement and comply with the guidance specified in [Section
    3.0](#section-3.0), *Programs and Processes*.

    3.  []{#OTA_OTC_Applicant .anchor}**OTA/OTC Applicant**

```{=html}
<!-- -->
```
A.  Determine the program needs for OTCs and/or OTAs and communicate the
    need to Site Management and/or Package Line Manager/Weapon System
    Program Manager and PCD.

B.  Implement and comply with the guidance specified in [Section
    3.0](#section-3.0), *Programs and Processes*.

C.  Use guidance in [Section
    3.5.3](#Applying_for_Recert_or_Mod_Applications) for determining
    whether the new content(s) can be added to the list of approved
    content(s) for a DOE/NNSA currently certified package or whether a
    new package must be designed, developed, certified and procured to
    need the need.

D.  If the OTA/OTC Applicant and the SARP/TSRA Development Organization
    are the same organization, the organization must:

    1.  Select staff and assign resources to develop the SARP/SARP
        addendum and/or TSRA.

    2.  Attend, support and participate in SARP/SARP addendum, TSRA and
        HAR related meetings, as needed.

    3.  Attend, support and participate in SARP/SARP addendum/TSRA
        kick-off meetings, as required.

    4.  Ensure that the SARP/SARP addendum, TSRA and/or HAR are prepared
        using the formats and contents specified in [Appendix
        B](#appendix-b). Refer to [Section 3.0](#section-3.0) and
        [Appendix A](#appendix-a) for additional information on the
        associated processes.

    5.  Distribute one copy of draft SARP/SARP addendum and/or TSRA to
        Site Management/ Package Line Manager/Weapon System Program
        Manager and four copies to recipients identified by PCD not
        later than nine months prior to the OTC/OTA need date.

    6.  Submit copy of draft HAR to Weapon System Program Manager and
        PCD not later than 60 days prior to the OTA need date.

    7.  Review the Qs developed by the TSRP during the SARP/SARP
        addendum /TSRA review, and develop and submit timely, correct
        and appropriate responses to Qs. Proposed changes to SARPs/SARP
        addendums and/or TSRAs and/or supporting documents must be
        submitted to PCD verbatim for review and approval before the
        SARPs/SARP addendums and/or TSRAs and/or supporting documents
        are changed.

    8.  Publish final SARP/SARP addendum and/or TSRA and/or supporting
        documents after the changes have been approved by PCD.

E.  If the organization selected to develop the SARP and/or TSRA is not
    the same organization as the OTC/OTA applicant, the applicant must:

    1.  Support and work closely with the SARP/TSRA Development
        Organization to ensure that it receives all of the data and
        information needed to develop the SARP/TSRA.

    2.  Ensure that the SARP/TSRA Development Organization understands
        the applicant's needs.

F.  Select staff and assign resources to develop the HAR.

###  OTA/OTC Users (consignors and consignees) {#otaotc-users-consignors-and-consignees .TextBold}

A.  Establish and maintain packaging staff that is qualified to perform
    packaging functions.

B.  Establish, maintain and implement a packaging program QAPP that
    meets the requirements of 10 CFR 830.120, 10 CFR 71 Subpart H, and
    QC-1, and that is approved by the Federal Site Manager.

C.  Establish and maintain open communications with DOE/NNSA PCD.

D.  Maintain file of current OTAs, OTCs, and SARPs and supporting
    documents and/or TSRAs, and SERs applicable to the site.

E.  Perform oversight of program operations.

F.  Perform annual self-assessment of their activities that support the
    DOE/NNSA packaging program, document the results and implement and
    maintain a corresponding corrective actions program.

G.  Support DOE/NNSA Headquarters in their appraisal/oversight function
    by providing members for appraisal/oversight teams.

H.  Verify that that there are no outstanding appraisal findings that
    might affect a packaging/shipment operation.

I.  Implement and comply with the guidance specified in [Section
    3.0](#section-3.0), *Programs and Processes*.

J.  Ensure compliance with the guidance provided in [Applicant's
    Checklist](#Adding_New_Contents_Applicants_Checklist) or [Other
    Perspective Package Users'
    Checklist](#Adding_New_Content_Other_Users_Checklist), as
    applicable, prior to using packaging that is authorized under a
    DOE/NNSA Deputy Administrator for Defense Programs exemption.

K.  Prepare a recovery plan in response to the DOE/NNSA Certifying
    Official's actions to prohibit the OTA/OTC user from using a
    specified OTA/OTC as a result of the user's noncompliance with
    SARPs, and/or OTC/OTA requirements, and submit the recovery plan to
    the DOE/NNSA Certifying Official and the PCD Manager for review and
    approval via the applicable management chain.

L.  Once all of the documents and processes listed above are in place
    and/or implemented, the following processes and requirements
    specific to the proposed operation must be followed:

    1.  Ensure that the site is an authorized user for the container
        prior to use by verifying that the DOE/NNSA OTA/OTC Web Page
        lists the Site as an authorized user of the package.

    2.  Ensure that site‑specific operating, handling, loading, tiedown,
        and maintenance (if applicable) procedures applicable to the
        packaging/shipment are written, approved and implemented, and
        that personnel have been trained and subsequently qualified in
        the performance of these activities.

    3.  []{#OTA_OTC_Users_Pkg_Procedures_and_QA_Plan .anchor}Ensure that
        draft packaging procedures, associated packaging quality
        assurance plan that complies with the requirements of 10 CFR 71
        Subpart H, and Site quality assurance plan are developed and
        submitted to DOE/NNSA for approval. Provide responses, to PCD
        review comments, that include prospective verbatim changes to
        the draft packaging procedures, associated packaging quality
        assurance plan that complies with the requirements of 10 CFR 71
        Subpart H, and Site quality assurance plan until all review
        comments are resolved and the packaging procedures and Site
        quality assurance plan are approved. If the DOE/NNSA Service
        Center, due to irresolvable deficiencies, is unable to approve a
        prospective user's packaging procedures, associated packaging
        quality assurance plan that complies with the requirements of 10
        CFR 71 Subpart H, and/or Site quality assurance plan, the
        DOE/NNSA Service Center will not designate the prospective user
        an authorized user of the package and the prospective user will
        be prohibited from using the package. If the prospective user
        disagrees with the DOE/NNSA Service Center's decision to not
        approve the prospective user as an authorized user, the
        prospective user is free to appeal this decision, with
        appropriate technical justification, to upper DOE/NNSA
        management. Approved package users shall publish, disseminate,
        maintain and use the approved packaging procedures, associated
        packaging quality assurance plan that complies with the
        requirements of 10 CFR 71 Subpart H, and Site quality assurance
        plan.

    4.  Comply with the requirements and restrictions specified in the
        applicable OTC, SER, and SARP and supporting documents, and OTA
        and SER, as applicable. Report noncompliance occurrences, and or
        concerns and issues to PCD.

    5.  Package and ship nuclear weapon components, Category I and II
        special nuclear materials, nuclear weapon program special
        assemblies, and other materials of national security interest in
        certified packages, handling gear or other packaging authorized
        specified in the applicable OTA or OTC.

### Technical Support Contractor {#technical-support-contractor .TextBold}

A.  Ensure that the technical support team leader has a proven record
    for managing and leading a team of highly competent technical SMEs.
    The team leader must be capable of taking inputs provided by the
    SMEs and consolidating them into an accurate and timely report that
    documents the results of a comprehensive SARP/TSRA review and
    associated confirmatory analysis.

B.  Submit monthly report that documents the status of SARP/TSRA review
    tasks and associated expenditures not later than the 15^th^ of each
    month to DOE/NNSA PCD. Refer to Appendix F for monthly report
    outline.

C.  Each SME must be an expert in his/her respective engineering and/or
    physical science field(s) and be knowledgeable of the NRC and DOT
    federal regulations, national standards and DOE Orders applicable to
    the packaging and shipment of RAM. Each SME must have successfully
    completed the two-week DOE sponsored SARP review training course
    provided by the Lawrence Livermore National Laboratory or undergo
    training specified by the PCD Manager (e.g., attend/participate in
    two SARP/TSRA reviews while undergoing on-the-job training, etc.).
    The SME's working relations must be conducive to functioning as an
    integral part of the TSRP team that must speak with a unified voice
    and work with the SARP/TSRA applicant's staff to resolve issues
    identified during the review. In case of a minority opinion on a
    specific topic or action, the SME is free to communicate his/her
    position to the federal TSRP Chairman.

D.  Develop and implement work plans that comply with the tasking
    provided by DOE/NNSA PCD to meet the SARP/TSRA review and
    confirmatory analysis needs.

E.  Attend, support and participate in SARP/TSRA kick-off meetings and
    other SARP and TSRA related meetings, as required.

F.  Document and communicate the technical review comments and questions
    developed during the SARP/TSRA reviews and associated confirmatory
    analysis and provide them to DOE/NNSA PCD. Refer to Appendix A for
    additional information on SARP/TSRA review scope and associated
    report requirements.

G.  Prepare and approve official confirmatory review correspondences and
    report, and ensure that records for confirmatory reviews are
    established and maintained.

H.  Submit official confirmatory review correspondence and report to
    DOE/NNSA PCD.

I.  Implement and comply with the guidance specified in [Section
    3](#section-3.0), *Programs and Processes*.

### Graded Approach {#graded-approach .TextBold}

The DOT regulations are so structured that materials representing a
greater hazard are subject to greater containment, communication, and
control requirements. 10 CFR 830.3 states that a graded approach means
the process of ensuring that the level of analysis, documentation, and
actions used to comply with a requirement in this part are commensurate
with the: relative importance to safety, safeguards, and security;
magnitude of any hazard involved; life cycle stage of an activity;
programmatic mission of an activity; particular characteristics of an
activity; relative importance of radiological and non-radiological
hazards; and any other relevant factor.

10 CFR 830.7 also states that where appropriate, a contractor must use a
graded approach to implement the requirements of this part, document the
basis of the graded approach used, and submit that documentation to DOE.

The contractor management's application of the requirements to the
activities associated with Offsite Packaging and Transportation
activities should be graded to provide the flexibility to design
controls that best suit the facility or activity after satisfying all
requirements mandated by law (Reference: 10 CFR 71.101(b).) The graded
approach process determines the appropriate level of effort necessary to
satisfy a requirement and then documents the level of effort. Factors to
be considered in the graded approach include: level of risk
(consequences of failure/being wrong); importance of data generated;
cost and schedule impacts; complexity of a packaging or transportation
process; importance of reproducibility or replacement; history of a
packaging or transportation process problem; importance of
standardization; application of regulations, codes, and standards (Note:
The 10 CFR 830 Rule does not allow for the use of the graded approach
with regard to implementing unreviewed safety questions (USQ) or in
implementing technical safety requirements.); need for process
control/special controls; importance of functional compliance by
inspection or test; importance of special handling, shipping or storage;
adequacy of existing safety documentation; and complexity of products or
services involved.

The basis and methodology for selecting an action pursuant to the graded
approach, to the extent that is consistent with its importance to
safety, should be documented in the QAPP.

### 2.4 Applicable Standards/Requirements {#applicable-standardsrequirements .TextBold .unnumbered}

All pertinent standards and requirements are as cited in DOE Order
461.1A,

10 CFR 71, 49 CFR 100-185, and 10 CFR 830.120.

# SECTION 3.0 {#section-3.0 .unnumbered}

# PROGRAMS AND PROCESSES {#programs-and-processes .unnumbered}

1.  []{#Introduction_Programs_Processes .anchor}Introduction

This section provides requirements and guidance for establishing and
maintaining a program and processes for gaining and maintaining approval
for packaging and/or shipping DOE/NNSA nuclear weapon components,
Category I and II SNM, nuclear weapon program special assemblies, and
other materials of national security interest. It also contains
information on when a user's authorization to use a certified Type B
package may be revoked and who can authorize vehicles used to perform
the associated off-site transportation operations.

**3.2** []{#CArgo_Packing_Loading_Transportation_Req .anchor}**Cargo
Packing, Loading and Transportation Requirements**

In accordance with 49 CFR 173, nuclear components with greater than
A~1~/A~2~ quantities should be packaged in Type B containers. Hazardous
materials combinations for special assemblies are packaged in accordance
with the following criteria:

A.  Explosives with depleted uranium and/or Be/BeO should be packaged in
    accordance with 49 CFR.

B.  High explosives (HE) with the detonators attached and depleted
    uranium should be packaged in accordance with 49 CFR and the
    explosive contents should be classified.

C.  Radioactive materials greater than A~1~/A~2~ quantity and live
    detonators with mock HE should be packaged in accor­dance with 10 CFR
    71 or equivalent criteria, and an OTC/OTA should be issued on a
    case-by-case basis by DOE/NNSA Certifying Official.

D.  Radioactive materials less than A~1~/A~2~ quantity with HE should be
    shipped in accordance with 49 CFR performance based packaging
    criteria under an OTA.

E.  Hazardous components other than the DOT Class 1, Division 1.1
    explosives (49 CFR 173.50) with depleted uranium should be
    transported in accordance with 49 CFR.

**3.3** []{#Prepackaging_Shipment_Determination_Docu
.anchor}**Pre-Packaging/Shipment Determinations and Document
Requirements**

Upon determination of the need for packaging/shipment of NNSA nuclear
weapon components, Category I and II SNM, nuclear weapon program special
assemblies, and other materials of national security interest containing
RAM, the DOE/NNSA contractor (customer) determines whether the quantity
of RAM should be categorized as a Type A or Type B quantity.

After the quantity of RAM is determined, the customer uses that
information to determine which of the following processes described in
the Sections 3.4 and [3.5](#type-b-quantity-ram) is applicable.

**3.4** []{#Type_A_Quantity_RAM .anchor}**Type A Quantity RAM**

**3.4.1** []{#DOT_Compliant_Shipments .anchor}**DOT Compliant
Shipments**

For shipments that contain a Type A quantity of RAM and are otherwise 49
CFR compliant, the Site/Contractor may make shipments of Type A
packaging in compliance with the Department of Transportation
regulations.

**3.4.2** []{#Type_AF_Packages_Certified_By_UK .anchor}**Type AF Package
Certified by United Kingdom Ministry of Defence (UK MOD) Transported in
TSS**

The Weapon System Program Manager shall submit a request to PCD and OST
for authorization to transport Type AF package UK MOD in the TSS. The
PCD Manager shall assign a CE or TSRP to evaluate the proposed UK MOD
Type AF package's compliance with 10 CFR 71 and 49 CFR 173 requirements,
and to assess the adequacy of the UK MOD's safety documentation and the
package by conducting or managing an independent confirmatory technical
assessment . This review shall consist of validation of the proper use
of the packaging for the application intended. The PCD shall assure that
the proposed configuration is within maintenance and serviceability
dates, and can be delivered within prescribed deadlines. Review of
DOE/NNSA users operating procedures are completed in accordance to work
process defined for US origin Type A packaging designs. The CE shall
also work with OST to ensure that the package is compatible with TSS
equipment and the tiedown procedures are contained in TP 45-51D, DOE
Tiedown Manuals or approved in a separate correspondence from OST to PCD
before an OTC/OTA is issued.

1.  []{#Shipment_of_Non_HiFi_NELAs .anchor}**Shipment of Nuclear Weapon
    Special Assemblies that contain less than Type B quantity of RAM or
    no RAM**

The shipper and receiver must be in the possession of the current
version of the OTA whose authorized content matches the content of the
special assembly proposed for off site shipment; or, must submit a
request for an OTA supported by a HAR, and wait until the OTA is issued
before making the shipment. See [Appendix B](#appendix-b) for guidance
developing the HAR.

### Type B Quantity RAM {#type-b-quantity-ram .TextBold}

Shipments that contain a Type B quantity of RAM must be packaged and
shipped in:

A.  Type B packaging certified under a DOE/NNSA OTC (see [Section
    3.5.1](#type-b-packaging-certified-under-an-doennsa-otc));

B.  Packaging or weapon handling gear specified in an OTA, (see [Section
    3.5.4](#NELAs_Containing_Type_B_RAM), as applicable);

C.  Type B packaging certified under a DOE certificate of compliance
    (CofC), (see [Section
    3.5.5](#Type_B_Packages_Certified_Under_CofCs));

D.  Type B packaging certified under an NRC or International Atomic
    Energy Agency (IAEA)/DOT certificate of competent authority (CofCA),
    (see [Section 3.5.6](#Packages_Certified_by_NRC_IAEA_DOT)); or,

E.  Type B packaging certified under a UK MOD certificate (see [Section
    3.5.7](#MOD_UK_Certified)).

### Type B Packaging Certified Under an DOE/NNSA OTC  {#type-b-packaging-certified-under-an-doennsa-otc .TextBold}

**A.** The Site working with the Packaging Line Manager identify Type B
quantity RAM and agree that the material must be shipped offsite.
Initial Certification: The SARP owner/applicant should comply with the
responsibilities listed in [Sections 2.2.8](#SARP_Owner) and
[2.2.12](#sarptsra-development-organization) for taking a proposed Type
B package through the initial certification process.

**B.** Applying for Recertification and/or Approval of Modifications for
NNSA Previously Certified Type B Packages: The SARP owner should use the
protocol provided in [Section
3.5.3](#Applying_for_Recert_or_Mod_Applications) when applying for a
recertification and/or an approval of a modification of a NNSA
previously certified Type B package.

**C.** Refer to [Appendix A Section
3.1](#sarp-and-tsra-review-process-and-timelines) for details on the
SARP review and approval process and timelines.

D. Use the following joint checklist to ensure that all the principles
(i.e., applicant, PCD and line Management) are exchanging information
needed to support a packaging and/or offsite transportation
authorization project:

+--------------------------------------+----+--------+----------------+
| # Joint PCD                          |    |        |                |
|  Certification Engineer, Site POC an |    |        |                |
| d Packaging Line Manager {#joint-pcd |    |        |                |
| -certification-engineer-site-poc-and |    |        |                |
| -packaging-line-manager .unnumbered} |    |        |                |
|                                      |    |        |                |
| # Packaging Project Checklist {#pack |    |        |                |
| aging-project-checklist .unnumbered} |    |        |                |
|                                      |    |        |                |
| **WARNING: All of the information on |    |        |                |
| this data sheet must be              |    |        |                |
| unclassified.**                      |    |        |                |
+======================================+====+========+================+
| **Action**                           | *  | *      | **Action       |
|                                      | *D | *Infor | Owner**        |
|                                      | ue | mation |                |
|                                      | Da | Prov   |                |
|                                      | te | ided** |                |
|                                      | ** |        |                |
+--------------------------------------+----+--------+----------------+
| ###                                  |    |        | PCD            |
| OTC or OTA Number Assigned (When PCD |    |        |                |
|  starts work on the project.) {#otc- |    |        |                |
| or-ota-number-assigned-when-pcd-star |    |        |                |
| ts-work-on-the-project. .unnumbered} |    |        |                |
+--------------------------------------+----+--------+----------------+
| **PCD CE** assigned (Name, Phone     |    |        | PCD            |
| Number and e-mail address)           |    |        |                |
+--------------------------------------+----+--------+----------------+
| **Site POC** (Name, Phone number and |    |        | Site in        |
| e-mail address)                      |    |        | coordination   |
|                                      |    |        | with the NNSA  |
|                                      |    |        | Packaging Line |
|                                      |    |        | Manager        |
+--------------------------------------+----+--------+----------------+
| **NNSA Line Management POC** (Name,  |    |        | NNSA Packaging |
| Phone Number and e-mail address)     |    |        | Line Manager   |
+--------------------------------------+----+--------+----------------+
| **Site** (LANL, LLNL, SNL/NM,        |    |        | Site in        |
| SNL/CA, etc) **& Project Identifier  |    |        | coordination   |
| if Assigned**                        |    |        | with the NNSA  |
|                                      |    |        | Packaging Line |
|                                      |    |        | Manager        |
+--------------------------------------+----+--------+----------------+
| **On-site Location of Material**     |    |        | Site in        |
|                                      |    |        | coordination   |
|                                      |    |        | with the NNSA  |
|                                      |    |        | Packaging Line |
|                                      |    |        | Manager        |
+--------------------------------------+----+--------+----------------+
| **Provide Security Classification    |    |        | Site in        |
| Level of Material and identify the   |    |        | coordination   |
| Security Guide that specifies the    |    |        | with the NNSA  |
| material's security classification   |    |        | Packaging Line |
| level.**                             |    |        | Manager        |
+--------------------------------------+----+--------+----------------+
| ## OTC/Shipping need date            |    |        | Site in        |
|                                      |    |        | coordination   |
|                                      |    |        | with the NNSA  |
|                                      |    |        | Packaging Line |
|                                      |    |        | Manager        |
+--------------------------------------+----+--------+----------------+
| ## Proposed Destination              |    |        | Site in        |
|                                      |    |        | coordination   |
|                                      |    |        | with the NNSA  |
|                                      |    |        | Packaging Line |
|                                      |    |        | Manager        |
+--------------------------------------+----+--------+----------------+
| **Work with SARP/TSRA Owner & PCD to |    |        | Site in        |
| Determine Documentation Required**   |    |        | coordination   |
| (Using proposed specific content(s)' |    |        | with the NNSA  |
| chemical and physical properties,    |    |        | Packaging Line |
| isotopic characterization and        |    |        | Manager        |
| activity, A~2~s, thermal             |    |        |                |
| properties/decay heat/wattage,       |    |        |                |
| criticality potential, and           |    |        |                |
| three-dimensional volume and weight  |    |        |                |
| in the proposed shipping             |    |        |                |
| configuration(s) and the candidate   |    |        |                |
| Packages' SARPs.                     |    |        |                |
+--------------------------------------+----+--------+----------------+
| **Identify Candidate Packaging**     |    |        | SARP/TSRA      |
|                                      |    |        | Owner & NNSA   |
|                                      |    |        | Packaging      |
|                                      |    |        | manager in     |
|                                      |    |        | coordination   |
|                                      |    |        | with PCD       |
+--------------------------------------+----+--------+----------------+
| **If OTC, Determine whether SARP or  |    |        | SARP Owner in  |
| SARP Addendum is appropriate**       |    |        | coordination   |
|                                      |    |        | with PCD       |
+--------------------------------------+----+--------+----------------+
| **Establish a formal agreement, with |    |        | Site in        |
| the SARP/TSRA owner that documents   |    |        | coordination   |
| the project's actions and            |    |        | with the NNSA  |
| milestones.**                        |    |        | Packaging Line |
|                                      |    |        | Manager        |
+--------------------------------------+----+--------+----------------+
| **Draft SARP/SARP Addendum/TSRA      |    |        | SARP/TSRA      |
| Submitted**                          |    |        | Owner (Y-12,   |
|                                      |    |        | LANL, LLNL,    |
|                                      |    |        | etc.)          |
+--------------------------------------+----+--------+----------------+
| ### SARP/TSRA R                      |    |        | PCD            |
| eview {#sarptsra-review .unnumbered} |    |        |                |
+--------------------------------------+----+--------+----------------+
| **Review SARP/SARP Addendum/TSRA &   |    |        | TSRP           |
| prepare & submit comments to the     |    |        |                |
| TSRP chairman**                      |    |        |                |
+--------------------------------------+----+--------+----------------+
| **Perform Confirmatory Analysis**    |    |        | Confirmatory   |
|                                      |    |        | organization   |
|                                      |    |        | under the      |
|                                      |    |        | direction of   |
|                                      |    |        | PCD            |
+--------------------------------------+----+--------+----------------+
| **Consolidate comments and           |    |        | TSRP Chairman  |
| distribute to TSRP members and the   |    |        |                |
| SARP/TSRA Owner**                    |    |        |                |
+--------------------------------------+----+--------+----------------+
| **TSRP & Applicant meet to discuss   |    |        | TSRP &         |
| draft Q~0~s (comments)**             |    |        | SARP/TSRA      |
|                                      |    |        | Owner          |
+--------------------------------------+----+--------+----------------+
| **Finalize and issue Q~0~**          |    |        | TSRP Chairman  |
+--------------------------------------+----+--------+----------------+
| **Complete confirmatory Analysis &   |    |        | Confirmatory   |
| submit comments to SARP/TSRA owner** |    |        | organization   |
|                                      |    |        | under the      |
|                                      |    |        | direction of   |
|                                      |    |        | PCD            |
+--------------------------------------+----+--------+----------------+
| **Develop and issue confirmatory     |    |        | Confirmatory   |
| report**                             |    |        | organization   |
|                                      |    |        | under the      |
|                                      |    |        | direction of   |
|                                      |    |        | PCD            |
+--------------------------------------+----+--------+----------------+
| **Prepare & submit Q~0~ Responses to |    |        | SARP/TSRA      |
| TSRP**                               |    |        | Owner (Y-12,   |
|                                      |    |        | LANL, LLNL,    |
|                                      |    |        | etc.)          |
+--------------------------------------+----+--------+----------------+
| **Review Q~0~ responses, & prepare & |    |        | TSRP           |
| submit Q~1~ comments which include   |    |        |                |
| confirmatory comments**              |    |        |                |
+--------------------------------------+----+--------+----------------+
| **Review Q~1~ comments & prepare &   |    |        | SARP/TSRA      |
| submit responses**                   |    |        | Owner          |
+--------------------------------------+----+--------+----------------+
| **Close out comments & approve       |    |        | Service Center |
| SARP/SARP Addendum/TSRA**            |    |        |                |
+--------------------------------------+----+--------+----------------+
| **Complete and distributes approved  |    |        | SARP/TSRA      |
| SARP/SARP Addendum/TSRA**            |    |        | owner          |
+--------------------------------------+----+--------+----------------+
| **Complete & distribute OTC/OTA, SER |    |        | Service Center |
| and transmittal letter**             |    |        |                |
+--------------------------------------+----+--------+----------------+
| **For OTC, Prepare Draft Packaging   |    |        | Prospective    |
| Procedures &Submit to PCD for        |    |        | Package Users  |
| approval**                           |    |        |                |
+--------------------------------------+----+--------+----------------+
| **For OTC, Submit QAP that meets 10  |    |        | Prospective    |
| CFR 71 Subpart H requirements to PCD |    |        | Package Users  |
| for Approval**                       |    |        |                |
+--------------------------------------+----+--------+----------------+
| **For OTC, Publish & disseminate     |    |        | Prospective    |
| copies of the approved packaging     |    |        | Package Users  |
| procedures & QAP.**                  |    |        |                |
+--------------------------------------+----+--------+----------------+
| **For OTC, Approve Site Packaging    |    |        | PCD            |
| Procedures & QAP & add the           |    |        |                |
| organization as an authorized user   |    |        |                |
| of the package on the PCD Web Site** |    |        |                |
+--------------------------------------+----+--------+----------------+
| **Close out data sheet & remove      |    | NA     | PCD            |
| hyperlink**                          |    |        |                |
+--------------------------------------+----+--------+----------------+

###  Actions Required of Prospective Package Users {#actions-required-of-prospective-package-users .TextBold}

Prospective users of Type B packagings must verify the following prior
to any use of a packaging to package any Type B quantity of RAM for
off-site shipment:

A.  The specific package (packaging and content) is certified under a
    current OTC; and,

B.  The prospective user (Site/Contractor) is an authorized user of the
    package; and has:

    1.  Current copies of the SARP, OTC and SER;

    2.  DOE/NNSA approved packaging procedures for the specific package;

    3.  DOE/NNSA approved QAPP; and,

    4.  Personnel that are trained and qualified to perform the
        applicable packaging and associated shipping functions.

Once the prospective user has verified all of the items listed above,
the user is authorized to prepare the package for shipment and to ship
the package via the transportation conveyance(s) authorized in the OTC.

1.  []{#How_to_Be_Authorized_Package_User .anchor}**How to Become an
    Authorized User of a Currently Certified Package**

The applicant is not an Authorized User for the Package, and/or does not
have one or any of the items listed in [3.5.1.1B(1) through
(4).](#actions-required-of-prospective-package-users) In this situation,
the applicant must apply to PCD for and be approved as an authorized
user of the package and have the items listed in [3.5.1.1B(1) through
(4)](#actions-required-of-prospective-package-users) in place before
that applicant can be authorized to use the package.

3.  []{#Process_for_Qualifying_Reservoirs .anchor}**Process for
    Qualifying Tritium Reservoirs for Packaging and Shipping in the
    H1616-1 and the H1616-2 Without Getter**

```{=html}
<!-- -->
```
A.  Applicant must evaluate the tritium reservoir proposed for shipment
    as outlined in the current issue of Sandia Specification *Reservoir
    Qualification AL-SX (H1616)(U),* SS393217.

B.  Applicant must submit reservoir qualification report that documents
    the evaluation of the reservoir proposed for shipment. The report
    must be prepared in the format specified in SS393217.

C.  The PCD reviews the reservoir qualification report and provides Qs
    to applicant based on the results of the review.

D.  Applicant provides responses to Qs that include proposed verbatim
    changes to the reservoir qualification report.

E.  Applicant and PCD achieve consensus on Qs and responses and PCD
    approves qualification report. If applicant and PCD are unable to
    achieve consensus, DOE/NNSA Service Center notifies the applicant,
    applicable Weapon System Program Manager, and DOE/NNSA management
    that the review was terminated.

F.  Applicant publishes and distributes the PCD-approved reservoir
    qualification report.

G.  The PCD directs the Sandia National Laboratories to add the newly
    qualified reservoir to the H1616-1 and H1616-2 Without Getter
    section of the Shipping Configuration Index, H1616 Container (U),
    SC395685.

H.  Sandia National Laboratories updates and distributes the revised
    SC395685.

I.  Authorized users of the H1616 use the updated SC395685 as their
    authorization to package and ship the qualified reservoir in the
    H1616-1 or the H1616-2 without getter.

**3.5.1.4** []{#Authorization_to_ship_Unqualified_Reserv
.anchor}**Process for Getting Authorization to Package and Ship
Unqualified or Suspect Tritium Reservoirs in the H1616-2 With Getter**

A.  A unqualified reservoir is a reservoir that has not been approved as
    qualified by the PCD in accordance with the SS393217 defined
    process, and therefore is not listed in the H1616-1 and H1616-2
    Without Getter section of the Shipping Configuration Index, H1616
    Container (U), SC395685. A suspect reservoir is a reservoir that has
    been approved as qualified by the PCD in accordance with the
    SS393217 defined process, but which the current custodian of the
    reservoir has determined that the reservoir may not meet the
    SS393217 requirements and/or could present a safety hazard to the
    workers, the public and/or the environment.

B.  Notify Sandia National Laboratories California (H1616 SARP Owner)
    and PCD about situation concerning the reservoir.

C.  Prepare and submit a request for authorization to package and ship
    the reservoir in the H1616-2 with getter and submit it to the PCD
    with a copy to Sandia National Laboratories California. In addition
    to the reservoir information described in SS393217 Section 4.3, the
    request should, at a minimum, provide the following additional
    information:

```{=html}
<!-- -->
```
1.  For Unqualified Reservoirs the applicant must follow the process
    prescribed in [Section 3.5.1.3](#Process_for_Qualifying_Reservoirs)
    above with the following modification:

    a.  Identify the SS393217 requirements that the reservoir proposed
        for shipment is unable to comply with and why;

    b.  Provide proof that the safety issues that could result from this
        reservoir being packaged and shipped offsite have been
        mitigated;

    c.  Provide any other supporting information, data and/or analysis
        requested by the Sandia National Laboratories and/or the PCD.

2.  For Suspect Reservoirs, the applicant must provide the following:

    a.  Detailed information on the condition of the reservoir and why
        it is suspect;

    b.  How the consequences associated with the failure of the suspect
        safety features of the reservoir will be mitigated during
        packaging and/or offsite shipment;

    c.  Provide any other supporting information, data and/or analysis
        requested by the Sandia National Laboratories and/or the PCD.

    ```{=html}
    <!-- -->
    ```
    A.  Sandia National Laboratories shall review the information/data
        provided by the applicant, perform any required analysis and
        provide their recommendations to the PCD.

    B.  The PCD in consultation with the Sandia National Laboratories
        shall develop a recommendation on this issue for presentation to
        the DOE/NNSA Certifying Official and upper DOE/NNSA management.

    C.  If the packaging and offsite transportation of an unqualified or
        suspect tritium reservoir is approved by the DOE/NNSA Certifying
        Official and/or upper DOE/NNSA management, the PCD shall prepare
        and distribute the correspondence to notify all concerned about
        the decision and to provide the applicable implementing
        instructions.

**3.5.2** []{#Process_for_Pkgs_Not_Currently_Certified .anchor}**Process
Options for Packages Not Currently Certified**

A.  The package is not a certified Type B package, but the applicant
    believes that the package can be certified. In this situation, the
    applicant must develop a draft SARP using the format provided in
    [Appendix B](#appendix-b), a completed SG 200 SARP Completeness
    Review Checklist and other supporting documents and submit copies to
    the individuals listed on a list provided by PCD and one copy to the
    Package Line Manager not later than nine months prior to the OTC
    need date.

B.  The package is not certified and cannot be shown to meet the letter
    of the requirements of 10 CFR 71 or 49 CFR 173. In this situation,
    the applicant must apply to PCD for an OTA by submitting an
    application that is supported by a SARP and supporting documents,
    and a TSRA for review and consideration not later than nine months
    prior to the OTC need date. The applicant must provide copies of the
    SARP, TSRA and supporting documents to the individuals listed on a
    list provided by PCD and one copy to the Package Line Manager. See
    Appendix B for guidance for developing TSRAs for these packages.

C.  The package is not certified and cannot be shown to meet the
    requirements of 10 CFR 71 or 49 CFR 173, but must still be shipped
    in the interest of national security. In this situation, the
    applicant can apply to NA-10 via its management chain, and PCD.

**3.5.3** []{#Applying_for_Recert_or_Mod_Applications
.anchor}**-Applying for and Processing Recertification and/or
Modification Applications for NNSA Previously Certified Type B
Packages**

NNSA previously certified packages proposed for recertification and/or
modification must satisfy the current 10 CFR 71 and 49 CFR 100-185
requirements, or if they cannot satisfy the current 10 CFR 71 and 49 CFR
100-185 requirements they must satisfy the previous 10 CFR 71 and 49 CFR
100-185 requirements in accordance with the provisions contained in the
10 CFR 71 section titled *Previously approved packages*.

**A.** If the package's certification has expired and the packaging is
determined to be a viable candidate for return to service, the SARP
owner should proceed to [Section
3.5.3.1](#Applying_for_Return_to_Service). If the package's
certification has not expired the SARP owner should continue the process
in this section.

**B.** If the package is not being modified but must be recertified
because its certification period is due to expire and the package is
still needed to support the Department's mission, the SARP owner should
proceed to [Section 3.5.3.2](#Applying_for_Recert_With_No_Mods). If the
package is being modified, the SARP owner should continue the process in
this section.

**C.** []{#Recert_Subsection_C .anchor}If the modification involves a
proposed change in the approved content and not a design change, the
SARP owner should proceed to SG 500 [Section
3.5.3.3](#Adding_new_Content). If the modification involves a design
change, the SARP owner should continue the process in this section.

**D.** The SARP owner should determine whether the design change is
significant with respect to the design, operating characteristics, or
safe performance of the containment system, when the package is subject
to the tests specified in 10CFR71.71 and 10CFR71.73. If the SARP owner
determines that the design change is significant, the SARP owner should
proceed to [Section 3.5.3.4](#Apply_for_Recert_W_Sig_Design_Changes). If
the SARP owner determines that the design change is not significant, the
SARP owner should continue the process in this section.

**E.** The SARP owner should develop an application that contains the
following:

1.  a detailed explanation of the proposed design change;

2.  the analysis used to verify that the determination that the design
    change with respect to the design, operating characteristics, or
    safe performance of the containment system, when the package is
    subject to the tests specified in 10CFR71.71 and 10CFR71.73 is not
    significant; and,

3.  a detailed plan for implementing the design change that includes the
    quality assurance process that will be used to ensure that the
    package continues to comply with 10CFR Subpart H and other quality
    assurance requirements.

The SARP owner should submit the application to PCD for review and
approval.

**F.** The PCD will review the application, and based on the results of
the review will notify the SARP owner via a memorandum that PCD:

1\. approves the design change and implementation plan; or,

2.  approves the design change, but does not approve the implementation
    plan. In this case, the PCD should provide comments on the
    implementation plan. The SARP owner should rework the implementation
    plan based on the guidance provided in the PCD comments, and
    resubmit the revised plan to PCD for approval. PCD approves the
    design change and implementation plan once PCD and the SARP owner
    reach consensus; or,

3.  determined that the design change is significant and directs the
    SARP owner to use the process specified in [Section
    3.5.3.4](#Apply_for_Recert_W_Sig_Design_Changes).

**3.5.3.1** []{#Applying_for_Return_to_Service .anchor}**Process for
Applying and Processing Applications for Returning Previously Certified
Type B Packages to Service**

The SARP owner supported by the Sites(s) that need to make the
shipment(s), performs an assessment to confirm that the previously
certified NNSA packaging is a viable candidate for recertification and
documents the results. The SARP owner submits the resultant documents to
PCD for review and concurrence. If PCD determines that the candidate
packaging is viable, and:

1.  if the previously certified package does not need to be modified and
    the proposed contents are identical to or bounded by the previously
    certified package's authorized content it advises the SARP owner to
    proceed to [Section 3.5.3.2](#Applying_for_Recert_With_No_Mods); or,

2.  if the package must be modified it advises the SARP owner to proceed
    to [Section 3.5.3.C](#Recert_Subsection_C).

    2.  []{#Applying_for_Recert_With_No_Mods .anchor}**Process for
        Applying for and Processing Applications for Recertifying
        Currently Certified Type B Packages with no Modifications**

Prepare a revised SARP, Supplemental Report, completed SG 200 SARP
Completeness Review Checklist and other supporting documents, and submit
them not later than 26 workweeks prior to OTC renewal need date to the
individuals on a list provided by PCD. Refer to [Appendix
B](#appendix-b) for guidance on preparing the SARP and Supplemental
Report. Refer to [Appendix A Section
3.2](#Timelines_for_recert_reauthorization) for the recertification
review and approval process sequence and timelines.

3.  []{#Adding_new_Content .anchor}**Process for Applying and Processing
    Applications for Adding New Content to a Currently Certified Type B
    Package**

This section is designed to guide the key participants through the
process of screening DOE/NNSA currently certified Type B packages for
candidate packaging(s) that might be suitable for packaging and shipping
Type B quantities of RAM (hereafter called specific content(s)),
preparing and submitting documents for approval of the new proposed
package, and the processing of these requests. [Section
3.5.3.3.1](#Adding_New_Content_in_Process_Sequence) describes the
process, in the prescribed chronological sequence, that should be used
by the key participants, and [Section 3.5.3.3.2](#Process_Checklists)
contains checklists that are designed to assist the key participants
([applicant](#Adding_New_Contents_Applicants_Checklist), DOE/NNSA [line
management](#Adding_New_Content_Line_Mgts_Checklist), [SARP
owners](#Adding_New_Content_SARP_Owners_Checklist), [other prospective
package users](#Adding_New_Content_Other_Users_Checklist), DOE/NNSA
[Deputy Administrator for Defense
Programs](#Adding_New_Content_DADP_Checklist),
[PCD](#Adding_New_Content_PCD_Checklist), DOE/NNSA [Certifying
Official](#Adding_New_Content_Cert_Officials_Checkl), and [Federal Site
Managers](#Adding_New_Content_Fed_Site_MGR_Checklis)) through this
process.

**3.5.3.3.1** []{#Adding_New_Content_in_Process_Sequence
.anchor}**Process Description Listed in Process Sequence-**

The DOE/NNSA line management, and the site (hereafter called applicant)
at which an item that contains a Type B quantity of RAM (hereafter
called specific content(s)) is located determine that the specific
content must to shipped off site.

The applicant determines and documents all of the pertinent information
such as the proposed specific content(s)' chemical and physical
properties, isotopic characterization and activity, A~2~s, thermal
properties/decay heat/wattage, criticality potential, and
three-dimensional volume and weight in the proposed shipping
configuration(s).

The applicant identifies the security classification level of the
proposed specific content(s), the security guide that specifies the
proposed specific content(s)' security classification level, and the
projected shipping need date.

The applicant, assisted by DOE/NNSA line management, screens DOE/NNSA
currently certified Type B packages to identify possible candidate
packaging(s) for this application based on the dimensions of the
proposed specific content(s) and the dimensions of the packaging(s) of
currently certified package(s). If no candidate packaging is identified
during this screening, the screening process will be terminated and the
applicant and DOE/NNSA line management can pursue the design,
development, certification and procurement of a new package. If
candidate packaging(s) are identified, the screening should continue,
and the applicant should determine if the site has a copy of the SARP(s)
for the candidate packaging(s).

For those candidate packaging(s) that the applicant has a copy of the
approved SARP, the applicant should compare the proposed specific
content(s)' chemical and physical properties, isotopic characterization
and activity, A~2~s, thermal properties/decay heat/wattage and
criticality potential, and three-dimensional volume and weight in the
proposed shipping configuration(s) to the capabilities of the candidate
packaging(s) to further refine the list of possible candidate
packaging(s). Once the applicant refines the list of candidate
packaging(s), the applicant should contact the owner(s) of the SARP(s)
of the candidate packaging(s) on the refined list with a request that
the SARP owner(s) assess the feasibility of packaging the proposed
specific content(s) in packaging(s) covered by their SARP(s). The
request should be supported by a data package that includes the proposed
specific content(s)' chemical and physical properties, isotopic
characterization and activity, A~2~s, thermal properties/wattage and
criticality potential and three-dimensional volume and weight in the
proposed shipping configuration(s).

For those candidate packaging(s) that the applicant does not has a copy
of the approved SARP(s), the applicant should contact the owner of the
SARP(s) to request that the SARP owner(s) assess the feasibility of
packaging the proposed specific contents in packaging covered by their
SARP(s). The request shall be supported by a data package that includes
the proposed specific content(s)' chemical and physical properties,
isotopic characterization and activity, A~2~s, thermal properties/decay
heat/wattage, criticality potential, and three-dimensional volume, and
weight in the proposed shipping configuration(s).

The SARP owner(s) contacted shall review the applicant's request(s)
using the data package provided by the applicant and the applicable
approved SARP. Once the review and associated analysis are completed,
the results will be provided to the applicant and PCD.

The applicant, using the information provided in the SARP owner(s)
response(s) and the requirements of 10 CFR 71 Section titled *Previously
approved package*, and in consultation with the SARP owner(s), selects
the best possible packaging candidate for the proposed application, or
determines that there is no packaging candidate that can meet the needs
of the proposed application. The screening should be terminated if no
candidate packaging, that can meet the needs of this application, is
identified.

If a candidate package is identified, the applicant, DOE/NNSA line
management, and the SARP owner of the candidate packaging should work
together to provide/identify the funding and to develop the schedule
needed to continue the screening process, and the DOE/NNSA line
management authorizes the SARP owner to begin the follow-on screening
process.

The SARP owner's initial task should include analytical work that can be
used to assess the candidate package's (candidate packaging with
proposed content(s)) viability for the proposed application. This
analytical work should include analysis on the candidate package's
criticality per 10 CFR 71, and shielding (or actual proposed content(s)
dose rate measurements which can be used to determine that shielding is
not an issue), and structural viability. The structural analysis should
be a complete analysis, or at a minimum, should be sufficiently
comprehensive to prove that the proposed configuration(s) is bounded by
the candidate packaging's currently approved configuration(s). The SARP
owner should document this analytical work and submit a copy of the
documentation to the applicant and PCD.

The applicant, concurrent with the SARP owner's submission of the
results of their criticality, shielding and structural analytical work,
should submit the proposed specific content(s)' chemical and physical
properties, isotopic characterization and activity, A~2~s, thermal
properties/decay heat/wattage, criticality potential, and
three-dimensional volume, and weight in the proposed shipping
configuration(s), and proposed shipping campaign information to the PCD.

The PCD, using the information provided by the SARP owner and the
applicant, will assess the viability of the candidate package. If the
PCD determines that the candidate package is not a viable candidate for
certification, the applicant and SARP owner should terminate the
screening process, but the applicant still has the option of pursuing
the development, certification and procurement of a new package, or of
developing and submitting a request for a DOE/NNSA Deputy Administrator
for Defense Programs exemption (addressed later in this process). If the
PCD determines that the candidate package is a viable candidate for
certification, the PCD should determine whether the application for
certification of the candidate package should be supported by a SARP or
a SARP addendum, and should inform the SARP owner and applicant of the
determination.

The applicant, SARP owner and DOE/NNSA line management should establish
a formal agreement that documents the agreed to actions and milestones
for each participant, and the data and other resources that the
applicant and/or DOE/NNSA line management will provide to the SARP
effort.

The applicant and/or DOE/NNSA line management should provide the
additional resources to the SARP owner before the SARP owner will
commence the work stipulated in the formal agreement.

The SARP owner performs the tasks required to support the development of
a draft SARP/SARP addendum and associated documents, develops the draft
SARP/SARP addendum and associated documents that complies with the
applicable requirements of 10 CFR 71 and 49 CFR 100-185, as specified in
DOE Order 461.1A (See the protocol that is provided in [Appendix
B](#appendix-b).), and submits the SARP/SARP addendum and associated
documents to the PCD for review. The SARP owner shall keep the PCD
informed of the project status, project delays and/or any project
difficulties.

The PCD performs a review and confirmatory analysis (hereafter called
review) of the SARP/SARP addendum and associated documents and provides
comments to the SARP owner, as specified in [Sections
2.2.3](#PCD_Mgr_Pkg_Cert_and_Ship_Authoriz_respo),
[2.2.3.1](#CE_Pkg_Cert_and_Ship_Authoriz_responsibi), and [Appendix
A](#appendix-a). The PCD will keep the DOE/NNSA Certifying Official
informed of project status, project delays and/or any project
difficulties.

The SARP owner performs the SARP/SARP addendum review process activities
specified in [Section 2.2.8](#SARP_Owner).

The applicant and other prospective package users begin the development
of their packaging quality assurance plans that comply with the
requirements of 10 CFR 71 Subpart H, and begin their review and, if
required, revision of their Site's quality assurance plan.

The PCD, through its SARP/SARP addendum review, and responses from the
SARP owner determines that the proposed package meets or doesn't meet
the applicable 10 CFR 71/49 CFR 100-185 requirements and can or cannot
be certified. If PCD determines that the proposed package can be
certified, proceed to Section A. If PCD determines that the proposed
package cannot be certified, proceed to [Section
B](#Proposed_Pkg_cannot_be_Certified).

A.  **Proposed Package Can Be Certified**

If the PCD determines that the proposed new package meets the applicable

10 CFR 71 and 49 CFR 100-185 requirements and can be certified:

1.  The PCD and the SARP owner resolve all of the draft SARP/SARP
    addendum review comments, and the PCD approves the draft SARP/SARP
    addendum.

2.  The applicant and prospective users submit their draft packaging
    quality assurance plans that comply with the requirements of 10 CFR
    71 Subpart H to the PCD for review and approval.

3.  The PCD reviews the draft packaging quality assurance plans to
    verify their compliance with 10 CFR 71 Subpart H, and approves the
    plans that comply with 10 CFR 71 Subpart H.

4.  The SARP owner publishes and distributes the final (approved)
    SARP/SARP addendum to the PCD, applicant and other prospective
    package users. If the PCD and the SARP owner are unable to resolve
    the SARP/SARP addendum review comments, the issues will be presented
    to DOE/NNSA upper management for resolution.

5.  The applicant and prospective users publish and distribute the
    packaging quality assurance plans that comply with 10 CFR 71 Subpart
    H.

6.  The PCD develops additional, if applicable, packaging and shipping
    restrictions for inclusion in the OTC and communicates them to the
    applicant and other prospective package users.

7.  The applicant and other prospective users start the development of
    the draft packaging procedures. The packaging procedures are based
    on the SARP/SARP addendum and OTC restrictions.

8.  The PCD follows the applicable portions of [Sections
    2.2.3](#PCD_Mgr_Pkg_Cert_and_Ship_Authoriz_respo) and
    [2.2.3.1](#CE_Pkg_Cert_and_Ship_Authoriz_responsibi), and Appendix C
    to develop a draft OTC, SER and distribution memorandum and submits
    them to the DOE/NNSA Certifying Official for approval.

9.  The DOE/NNSA Certifying Official certifies or doesn't certify the
    candidate package as specified in [Section
    2.2.2](#Certifying_Official_Subsection_B).

    a.  If the DOE/NNSA Certifying Official disapproves the
        certification of the new package the PCD Certification Engineer
        shall proceed as specified in [Section
        2.2.3.1.B.4(c)(4)](#CE_SER_OTC_OTA_Prep) .

    b.  If the DOE/NNSA Certifying Official certifies the new package
        the process continues.

10. The PCD distributes copies of the new OTC, SER and associated
    distribution memorandum to DOE/NNSA headquarters, Office of Secure
    Transportation, applicant, and other authorized package users.

11. The applicant and other prospective users submit their draft
    packaging procedures and their Site quality assurance plans to the
    PCD for review and approval, and support the review/approval process
    as specified in [Section
    2.2.14.L.3](#OTA_OTC_Users_Pkg_Procedures_and_QA_Plan).

12. The PCD processes the draft packaging procedures and Sites' quality
    assurance plans as specified in [Section
    2.2.3.1](#CE_Pkg_Cert_and_Ship_Authoriz_responsibi).

13. The PCD identifies the approved package users by updating the
    DOE/NNSA OTA/OTC Web Page.

14. The applicant and other prospective users check the DOE/NNSA OTA/OTC
    Web Page to verify that their Site is designated an approved user of
    the package. If the Web Site does not list their Site as an approved
    user of the package, they should contact the PCD for resolution.

15. The Federal Site Managers shall provide oversight of the packaging
    and off-site transportation associated activities at their site.

16. The authorized users of the newly certified package:

    a.  May commence packaging operations with the newly certified
        package as prescribed in SARP/SARP addendum, OTC, and SER.

    b.  May submit a transportation services request to the Office of
        Secure Transportation, in accordance to their prescribed format,
        to request and schedule off-site transportation services.

    c.  May commence shipping operations as prescribed in SARP/SARP
        addendum, OTC, and SER.

17. The SARP owner must ensure that when the SARP is revised for package
    recertification, the new SARP includes this new content(s), if there
    is still a need to ship these new content(s).

```{=html}
<!-- -->
```
B.  []{#Proposed_Pkg_cannot_be_Certified .anchor}**Proposed Package
    Cannot Be Certified**

The DOE/NNSA Service Center determines that the proposed new package
does not meets the applicable 10 CFR 71/49 CFR 100-185 requirements as
specified in DOE Order 461.1A and cannot be certified.

1.  The PCD notifies the applicant, SARP owner and applicable DOE/NNSA
    line managers of the determination.

2.  If the specified content(s) still needs to be shipped off site, the
    applicant, under the direction of applicable DOE/NNSA line
    management, must determine whether to initiate a request for the
    design of a new Type B package that will meet this need, or whether
    the applicant should request an exemption from the requirements of
    DOE Order 461.1A from the DOE/NNSA Deputy Administrator for Defense
    Programs.

3.  If the decision is made to request an exemption from the DOE/NNSA
    Deputy Administrator for Defense Programs, the applicant must
    prepare the exemption request. The exemption request must include
    evidence that indicates that the proposed shipment is not prohibited
    by law, and a technical analysis that supports a conclusion that the
    packaging and transportation operations of the proposed package do
    not present an undue risk to the public health and safety, the
    environment, or workers. The exemption request should be submitted
    via the applicant's contractor and Federal Site management, and the
    DOE/NNSA Service Center for their technical review and
    recommendations for approval/disapproval. The Federal Site Managers
    and DOE/NNSA Service Center must review the exemption request and
    provide their recommendations for approval/disapproval to the
    DOE/NNSA Deputy Administrator for Defense Programs.

4.  The DOE/NNSA Deputy Administrator for Defense Programs reviews the
    exemption request, and based on the results of its review of the
    analysis and documentation provided in the request, its own
    independent analysis, the exemption criteria of DOE Order 461.1A,
    and the recommendations provided by the other exemption request
    reviewers, grants or denies the exemption request.

    a.  If the DOE/NNSA Deputy Administrator for Defense Programs denies
        the exemption request, the correspondence which communicates the
        DOE/NNSA Deputy Administrator for Defense Programs' denial of
        the exemption should indicate whether the exemption request
        would be reconsidered if additional information/data were
        provided or whether the applicant should seek another solution
        for packaging the proposed content(s) (i.e., initiate a new
        packaging design).

    b.  If the DOE/NNSA Deputy Administrator for Defense Programs grants
        the exemption request, the correspondence that announces the
        granting of the exemption may include exemption implementing
        instructions, if applicable. The DOE/NNSA Deputy Administrator
        for Defense Programs shall address the correspondence to the
        Federal Site Manager of the applicant's Site and provide copies
        to the applicant, the DOE/NNSA Service Center Manager, and all
        other organizations to which the exemption applies.

        1.  The applicant, the applicant's Federal Site Managers and any
            other organization to which a DOE/NNSA Deputy Administrator
            for Defense Programs exemption is granted shall comply with
            the exemption and its implementing instructions.

        2.  The Federal Site Managers must ensure that the applicable
            contractors under their cognizance comply with the
            requirements of the DOE/NNSA Deputy Administrator for
            Defense Programs exemption and its implementing
            instructions.

        3.  The PCD and the SARP owner reach consensus on all SARP/SARP
            addendum comments.

        4.  The applicant and prospective users work with PCD to get
            their approval for the packaging quality assurance plans'
            format and content, and submit the packaging quality
            assurance plans to PCD for approval.

        5.  The PCD reviews the draft packaging quality assurance plans
            and approves, as applicable.

        6.  Applicant and prospective users publish and distribute their
            approved packaging quality assurance plans.

        7.  The PCD approves the draft SARP/SARP addendum, and the SARP
            owner publishes and distributes the final SARP/SARP
            addendum.

        8.  The PCD provides a list of the restrictions that will be
            imposed, via the OTA, on this package's packaging and
            shipping operations to the applicant and other prospective
            user(s).

        9.  The applicant/other prospective package users develop draft
            packaging procedures and Site quality assurance plans based
            on the final SARP/SARP addendum, DOE/NNSA Deputy
            Administrator for Defense Programs exemption and packaging
            and shipping restrictions contained in the OTA, and submits
            them to the PCD for review and approval.

        10. The PCD processes the draft packaging procedures and quality
            assurance plans as specified in [Section
            2.2.3.1](#CE_Pkg_Cert_and_Ship_Authoriz_responsibi).

        11. The PCD uses the final DOE/NNSA Deputy Administrator for
            Defense Programs exemption and approved SARP/SARP addendum
            to develop a draft OTA, SER and distribution memorandum and
            submits them to the DOE/NNSA Certifying Official for
            approval.

        12. The DOE/NNSA Certifying Official processes the draft SER,
            OTA and distribution memorandum as specified in [Section
            2.2.2.B.4](#Certifying_Official_Subsection_B).

        13. The PCD distributes the new OTA, SER and distribution
            memorandum, and updates the DOE/NNSA OTA/OTC Web Page.

        14. The applicant's Federal Site Manager is the final authority
            for authorizing the shipment. Therefore, no packaging or
            transportation, with this packaging, may commence until the
            applicant's Federal Site Manager [authorizes]{.underline}
            the packaging/shipment.

> \(a\) Disapproves the proposed packaging and shipment and advises the
> applicant on how to proceed, and the DOE/NNSA Deputy Administrator for
> Defense Programs, PCD, and other prospective users of the decision;
> or,
>
> \(b\) Authorizes the packaging and transportation to commence.

15. The authorized users of this packaging may commence packaging
    operations with this packaging as prescribed in SARP/SARP addendum,
    OTA, and SER, DOE/NNSA Deputy Administrator for Defense Programs
    exemption, and restrictions and/or guidance provided by the
    applicant's Federal Site Manager.

16. Authorized users of this packaging may submit a transportation
    services request to the Office of Secure Transportation, in
    accordance to their prescribed format, to request and schedule
    off-site transportation services.

17. Authorized users of this packaging may commence shipping operations
    as prescribed in SARP/SARP addendum, OTA, SER, DOE/NNSA Deputy
    Administrator for Defense Programs exemption, and restrictions
    and/or guidance provided by the applicant's Federal Site Manager.

**3.5.3.3.2** []{#Process_Checklists .anchor}**Process Checklists**

+-----+----------------------------------------------------+-----------+
| []  |                                                    |           |
| {#A |                                                    |           |
| ddi |                                                    |           |
| ng_ |                                                    |           |
| New |                                                    |           |
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| nte |                                                    |           |
| nts |                                                    |           |
| _Ap |                                                    |           |
| pli |                                                    |           |
| can |                                                    |           |
| ts_ |                                                    |           |
| Che |                                                    |           |
| ckl |                                                    |           |
| ist |                                                    |           |
| .a  |                                                    |           |
| nch |                                                    |           |
| or} |                                                    |           |
| **A |                                                    |           |
| ppl |                                                    |           |
| ica |                                                    |           |
| nt' |                                                    |           |
| s** |                                                    |           |
|     |                                                    |           |
| *   |                                                    |           |
| *Ch |                                                    |           |
| eck |                                                    |           |
| lis |                                                    |           |
| t** |                                                    |           |
|     |                                                    |           |
| P   |                                                    |           |
| roc |                                                    |           |
| ess |                                                    |           |
| for |                                                    |           |
| G   |                                                    |           |
| ett |                                                    |           |
| ing |                                                    |           |
| Ap  |                                                    |           |
| pro |                                                    |           |
| val |                                                    |           |
| for |                                                    |           |
| Add |                                                    |           |
| ing |                                                    |           |
| New |                                                    |           |
| C   |                                                    |           |
| ont |                                                    |           |
| ent |                                                    |           |
| to  |                                                    |           |
| a   |                                                    |           |
|     |                                                    |           |
| DO  |                                                    |           |
| E/N |                                                    |           |
| NSA |                                                    |           |
| Cur |                                                    |           |
| ren |                                                    |           |
| tly |                                                    |           |
| Cer |                                                    |           |
| tif |                                                    |           |
| ied |                                                    |           |
| T   |                                                    |           |
| ype |                                                    |           |
| B   |                                                    |           |
| P   |                                                    |           |
| ack |                                                    |           |
| age |                                                    |           |
+=====+====================================================+===========+
| **  | **Activity**                                       | **C       |
| Ste |                                                    | ompletion |
| p** |                                                    | Date**    |
+-----+----------------------------------------------------+-----------+
| 1   | Identifies item containing a Type B quantify of    |           |
|     | RAM and works with DOE/NNSA line management to     |           |
|     | determine whether the item must be shipped off     |           |
|     | site. If the determination indicates that the item |           |
|     | must be shipped off site, this process should      |           |
|     | continue. Otherwise the process should end.        |           |
+-----+----------------------------------------------------+-----------+
| 2   | Determines and documents all of the pertinent      |           |
|     | information such as the proposed specific          |           |
|     | content(s)' chemical and physical properties,      |           |
|     | isotopic characterization and activity, A~2~s,     |           |
|     | thermal properties/decay heat/wattage, criticality |           |
|     | potential, and three-dimensional volume and weight |           |
|     | in the proposed shipping configuration(s).         |           |
+-----+----------------------------------------------------+-----------+
| 3   | Identifies the security classification level of    |           |
|     | the proposed specific content(s), the security     |           |
|     | guide that specifies the proposed specific         |           |
|     | content(s)' security classification level, and the |           |
|     | projected shipping need date.                      |           |
+-----+----------------------------------------------------+-----------+
| 4   | Screens DOE/NNSA currently certified Type B        |           |
|     | packages to identify possible candidate            |           |
|     | packaging(s) for this application based on the     |           |
|     | dimensions of the proposed specific content(s) and |           |
|     | the dimensions of the candidate packaging(s) with  |           |
|     | the assistance of DOE/NNSA line management. If no  |           |
|     | candidate packaging is identified during this      |           |
|     | screening, the screening process will be           |           |
|     | terminated and the applicant and DOE/NNSA line     |           |
|     | management can pursue the design, development,     |           |
|     | certification and procurement of a new package. If |           |
|     | candidate packaging(s) are identified, the         |           |
|     | screening should continue.                         |           |
+-----+----------------------------------------------------+-----------+
| 5   | Determines whether or not the site has a copy of   |           |
|     | the SARP(s) for the candidate packaging(s).        |           |
+-----+----------------------------------------------------+-----------+
| 5.a | If approved SARP(s) for those candidate            |           |
|     | packaging(s) are available, compare the proposed   |           |
|     | specific content(s)' chemical and physical         |           |
|     | properties, isotopic characterization and          |           |
|     | activity, A~2~s, thermal properties/decay          |           |
|     | heat/wattage, criticality potential, and           |           |
|     | three-dimensional volume and weight in the         |           |
|     | proposed configurations to the capabilities of the |           |
|     | candidate packaging(s) to further refine the list  |           |
|     | of possible candidate packaging(s).                |           |
+-----+----------------------------------------------------+-----------+
| 5.b | If approved SARP(s) for candidate packaging(s) are |           |
|     | not available, but the site still believes that    |           |
|     | the packaging(s) could be a viable candidate       |           |
|     | packaging(s), adds the packaging(s) to the refined |           |
|     | list of possible candidate packaging(s).           |           |
+-----+----------------------------------------------------+-----------+
| 6   | Develops request(s) that are supported by a data   |           |
|     | package that includes the proposed specific        |           |
|     | content(s)' chemical and physical properties,      |           |
|     | isotopic characterization and activity, A~2~s,     |           |
|     | thermal properties/wattage and criticality         |           |
|     | potential, and three-dimensional volume and weight |           |
|     | in the proposed shipping configuration(s).         |           |
+-----+----------------------------------------------------+-----------+
| 7   | Submits the request(s) to the SARP(s) owner(s) of  |           |
|     | the candidate packaging(s) requesting that the     |           |
|     | SARP owner(s) assess the feasibility of packaging  |           |
|     | the proposed specific content(s) in packaging(s)   |           |
|     | covered by their SARP(s).                          |           |
+-----+----------------------------------------------------+-----------+
| 8   | Reviews the results of the SARP owner(s)'          |           |
|     | assessment(s).                                     |           |
+-----+----------------------------------------------------+-----------+
| 9   | Uses the information provided in the SARP owner(s) |           |
|     | responses and the requirements in 10 CFR 71        |           |
|     | Section titled *Previously approved package*, and  |           |
|     | consults with the SARP owner(s) to select the best |           |
|     | possible packaging candidate or to determine that  |           |
|     | there is no viable packaging candidate for the     |           |
|     | proposed application. If no packaging candidate is |           |
|     | identified, the screening process should end.      |           |
+-----+----------------------------------------------------+-----------+
| 10  | Works with DOE/NNSA line management and the SARP   |           |
|     | owner of the candidate packaging to                |           |
|     | provide/identify the funding and schedule needed   |           |
|     | to continue the screening process.                 |           |
+-----+----------------------------------------------------+-----------+
| 11  | Submits the specific content(s)' chemical and      |           |
|     | physical properties, isotopic characterization and |           |
|     | activity, A~2~s, thermal properties/decay          |           |
|     | heat/wattage, criticality potential, and           |           |
|     | three-dimensional volume and weight in the         |           |
|     | proposed shipping configuration(s), plus           |           |
|     | information on the proposed shipping campaign to   |           |
|     | PCD concurrently with the SARP owner's submission  |           |
|     | of the results of their criticality, shielding and |           |
|     | structural analysis.                               |           |
+-----+----------------------------------------------------+-----------+
| 12  | Reviews the SARP owner(s)' submissions.            |           |
+-----+----------------------------------------------------+-----------+
| 13  | When the PCD, after their review of the SARP       |           |
|     | owner's criticality, shielding and structural      |           |
|     | analysis, and the information provided by the SARP |           |
|     | owner, determines that the candidate packaging     |           |
|     | is/isn't a viable candidate for certification:     |           |
+-----+----------------------------------------------------+-----------+
| 1   | Terminates the screening process and pursues the   |           |
| 3.a | development, certification and procurement of a    |           |
|     | new package, or develops and submits a request for |           |
|     | a DOE/NNSA Deputy Administrator for Defense        |           |
|     | Programs exemption if PCD determines that the      |           |
|     | candidate packaging is not a viable certification  |           |
|     | candidate.                                         |           |
+-----+----------------------------------------------------+-----------+
| 1   | Continues the screening process if PCD determines  |           |
| 3.b | that the candidate packaging is a viable candidate |           |
|     | for certification.                                 |           |
+-----+----------------------------------------------------+-----------+
| 14  | Works with the SARP owner and DOE/NNSA line        |           |
|     | management to determine the need date for the      |           |
|     | certification of the new package, and determine    |           |
|     | the funding, data, and/or other resources needed   |           |
|     | by the SARP owner to revise the SARP or to develop |           |
|     | a SARP addendum in support of this effort.         |           |
+-----+----------------------------------------------------+-----------+
| 15  | Establishes a formal agreement, with the SARP      |           |
|     | owner and DOE/NNSA line management that documents  |           |
|     | the agreed to actions and milestones for each      |           |
|     | participant, and the resources that will be        |           |
|     | provided to the SARP owner.                        |           |
+-----+----------------------------------------------------+-----------+
| 16  | Works with DOE/NNSA line management to provide the |           |
|     | additional resources to the SARP owner before the  |           |
|     | SARP owner commences the work stipulated in the    |           |
|     | formal agreement discussed immediately above.      |           |
+-----+----------------------------------------------------+-----------+
| 17  | Supports the SARP owner during the SARP/SARP       |           |
|     | addendum development and approval process.         |           |
+-----+----------------------------------------------------+-----------+
| 18  | Participates in draft SARP/SARP addendum comment   |           |
|     | resolution, as required by the formal agreement    |           |
|     | addressed in Step 15 above.                        |           |
+-----+----------------------------------------------------+-----------+
| 19  | Begins the development of their packaging quality  |           |
|     | assurance plans that comply with the requirements  |           |
|     | of 10 CFR 71 Subpart H, and begins their review    |           |
|     | and, if required, revision of their Site's quality |           |
|     | assurance plan.                                    |           |
+-----+----------------------------------------------------+-----------+
| 20  | If the PCD determines that the proposed package    |           |
|     | can be certified, the process may proceed to [Step |           |
|     | 23](#Step_Two_Three). If the PCD determines that   |           |
|     | the proposed package cannot be certified, the      |           |
|     | process must proceed to [Step 21](#Step_Two_One).  |           |
+-----+----------------------------------------------------+-----------+
| [   | Works with DOE/NNSA line to determine whether to   |           |
| ]{# | initiate the design of a new Type B package that   |           |
| Ste | will meet this need, or whether to request an      |           |
| p_T | exemption from the requirements of DOE Order       |           |
| wo_ | 461.1A from the DOE/NNSA Deputy Administrator for  |           |
| One | Defense Programs.                                  |           |
| .   |                                                    |           |
| anc |                                                    |           |
| hor |                                                    |           |
| }21 |                                                    |           |
+-----+----------------------------------------------------+-----------+
| 22  | Performs the following functions/activities if the |           |
|     | decision is to pursue a DOE/NNSA Deputy            |           |
|     | Administrator for Defense Programs exemption:      |           |
+-----+----------------------------------------------------+-----------+
| 2   | Prepares the exemption request. The exemption      |           |
| 2.a | request must include evidence that indicates that  |           |
|     | the proposed shipment is not prohibited by law,    |           |
|     | and a technical analysis that supports a           |           |
|     | conclusion that the packaging and shipment of the  |           |
|     | proposed package do not present an undue risk to   |           |
|     | public health and safety, the environment, or      |           |
|     | workers.                                           |           |
+-----+----------------------------------------------------+-----------+
| 2   | Submitted the request via the Site's contractor    |           |
| 2.b | and federal management, and the DOE/NNSA Service   |           |
|     | Center Manager via PCD for their technical review  |           |
|     | and recommendations for approval/disapproval.      |           |
+-----+----------------------------------------------------+-----------+
| 2   | [Do not proceed with any subsequent process steps  |           |
| 2.c | unless]{.underline} the DOE/NNSA Deputy            |           |
|     | Administrator for Defense Programs grants the      |           |
|     | exemption.                                         |           |
+-----+----------------------------------------------------+-----------+
| []{ | Submits draft packaging quality assurance plan to  |           |
| #St | the PCD for approval:                              |           |
| ep_ |                                                    |           |
| Two |                                                    |           |
| _Th |                                                    |           |
| ree |                                                    |           |
| .   |                                                    |           |
| anc |                                                    |           |
| hor |                                                    |           |
| }23 |                                                    |           |
+-----+----------------------------------------------------+-----------+
| 2   | For certified packages, the plan must comply with  |           |
| 3.a | the requirements contained in 10 CFR 71 Subpart H  |           |
|     | in its entirety.                                   |           |
+-----+----------------------------------------------------+-----------+
| 2   | For packaging authorized under a DOE/NNSA Deputy   |           |
| 3.b | Administrator for Defense Programs grants the      |           |
|     | exemption, the plan format and content must be     |           |
|     | approved by the PCD.                               |           |
+-----+----------------------------------------------------+-----------+
| 24  | Ensures that the Site receives a copy of the new   |           |
|     | SARP/SARP addendum.                                |           |
+-----+----------------------------------------------------+-----------+
| 25  | Publishes and distributes the approved packaging   |           |
|     | quality assurance plan.                            |           |
+-----+----------------------------------------------------+-----------+
| 26  | Ensures that the Site receives a copy of           |           |
|     | restrictions that will be contained in the OTC/OTA |           |
|     | from the PCD.                                      |           |
+-----+----------------------------------------------------+-----------+
| 27  | Develops draft packaging procedures that are based |           |
|     | on the SARP/SARP addendum and OTC/OTA              |           |
|     | restrictions, and if applicable the DOE/NNSA       |           |
|     | Deputy Administrator for Defense Programs          |           |
|     | exemption and restrictions and/or guidance         |           |
|     | provided by the applicant's Federal Site Manager.  |           |
+-----+----------------------------------------------------+-----------+
| 28  | Submits the draft packaging procedures and the     |           |
|     | associated Site quality assurance plan to the PCD  |           |
|     | for review and approval, and supports the review   |           |
|     | process as specified in SG 500 [Section            |           |
|     | 2.2.1                                              |           |
|     | 4.L.3](#OTA_OTC_Users_Pkg_Procedures_and_QA_Plan). |           |
+-----+----------------------------------------------------+-----------+
| 29  | Publishes and disseminates copies of the approved  |           |
|     | packaging procedures and Site quality assurance    |           |
|     | plan (if revisions are made).                      |           |
+-----+----------------------------------------------------+-----------+
| 30  | Ensures that the Site receives a copy of the new   |           |
|     | OTC/OTA and SER.                                   |           |
+-----+----------------------------------------------------+-----------+
| 31  | Checks the DOE/NNSA OTA/OTC Web Page to verify     |           |
|     | that the Site is an authorized user for this       |           |
|     | package. Contacts the PCD if the Site is not       |           |
|     | listed as an authorized user of this package, but  |           |
|     | should be listed.                                  |           |
+-----+----------------------------------------------------+-----------+
| 32  | Does not commence packaging operations that must   |           |
|     | be performed under a DOE/NNSA Deputy Administrator |           |
|     | for Defense Programs exemption until the Site has  |           |
|     | implemented all of the requirements specified in   |           |
|     | the DOE/NNSA Deputy Administrator for Defense      |           |
|     | Programs exemption and the Federal Site Manger has |           |
|     | authorized the Site to proceed with these          |           |
|     | operations.                                        |           |
+-----+----------------------------------------------------+-----------+
| 33  | Commences packaging operations with the newly      |           |
|     | certified package or the packaging authorized      |           |
|     | under a DOE/NNSA Deputy Administrator for Defense  |           |
|     | Programs exemption, as applicable, using the       |           |
|     | approved packaging procedures, SARP/SARP addendum, |           |
|     | OTC/OTA, SER, and if applicable the DOE/NNSA       |           |
|     | Deputy Administrator for Defense Programs          |           |
|     | exemption instructions and restrictions and/or     |           |
|     | guidance provided by the applicant's Federal Site  |           |
|     | Manager.                                           |           |
+-----+----------------------------------------------------+-----------+
| 34  | Submits a transportation services request to the   |           |
|     | Office of Secure Transportation, in accordance to  |           |
|     | their prescribed format, to request and schedule   |           |
|     | off-site transportation services.                  |           |
+-----+----------------------------------------------------+-----------+
| 35  | Commences shipping operations as prescribed in     |           |
|     | SARP/SARP addendum, OTC/OTA, SER, and if           |           |
|     | applicable the DOE/NNSA Deputy Administrator for   |           |
|     | Defense Programs exemption instructions and        |           |
|     | restrictions and/or guidance provided by the       |           |
|     | applicant's Federal Site Manager.                  |           |
+-----+----------------------------------------------------+-----------+

+-----+----------------------------------------------------+-----------+
| []{ |                                                    |           |
| #Ad |                                                    |           |
| din |                                                    |           |
| g_N |                                                    |           |
| ew_ |                                                    |           |
| Con |                                                    |           |
| ten |                                                    |           |
| t_L |                                                    |           |
| ine |                                                    |           |
| _Mg |                                                    |           |
| ts_ |                                                    |           |
| Che |                                                    |           |
| ckl |                                                    |           |
| ist |                                                    |           |
| .an |                                                    |           |
| cho |                                                    |           |
| r}* |                                                    |           |
| *DO |                                                    |           |
| E/N |                                                    |           |
| NSA |                                                    |           |
| L   |                                                    |           |
| ine |                                                    |           |
| Ma  |                                                    |           |
| nag |                                                    |           |
| eme |                                                    |           |
| nt' |                                                    |           |
| s** |                                                    |           |
|     |                                                    |           |
| *   |                                                    |           |
| *Ch |                                                    |           |
| eck |                                                    |           |
| lis |                                                    |           |
| t** |                                                    |           |
|     |                                                    |           |
| P   |                                                    |           |
| roc |                                                    |           |
| ess |                                                    |           |
| for |                                                    |           |
| G   |                                                    |           |
| ett |                                                    |           |
| ing |                                                    |           |
| Ap  |                                                    |           |
| pro |                                                    |           |
| val |                                                    |           |
| for |                                                    |           |
| Add |                                                    |           |
| ing |                                                    |           |
| New |                                                    |           |
| C   |                                                    |           |
| ont |                                                    |           |
| ent |                                                    |           |
| to  |                                                    |           |
| a   |                                                    |           |
|     |                                                    |           |
| DO  |                                                    |           |
| E/N |                                                    |           |
| NSA |                                                    |           |
| Cur |                                                    |           |
| ren |                                                    |           |
| tly |                                                    |           |
| Cer |                                                    |           |
| tif |                                                    |           |
| ied |                                                    |           |
| T   |                                                    |           |
| ype |                                                    |           |
| B   |                                                    |           |
| P   |                                                    |           |
| ack |                                                    |           |
| age |                                                    |           |
+-----+----------------------------------------------------+-----------+
| **  | **Activity**                                       | **C       |
| Ste |                                                    | ompletion |
| p** |                                                    | Date**    |
+-----+----------------------------------------------------+-----------+
| 1   | Works with site (applicant) to determine whether   |           |
|     | the item must be shipped off site. If the          |           |
|     | determination indicates that the item must be      |           |
|     | shipped off site, this process should continue.    |           |
|     | Otherwise the process should end.                  |           |
+-----+----------------------------------------------------+-----------+
| 2   | Assists the applicant in the screening of          |           |
|     | currently certified packages to identify possible  |           |
|     | candidate packaging(s) for this application based  |           |
|     | on the dimensions of the proposed specific         |           |
|     | content(s) and the dimensions of the packaging(s)  |           |
|     | of DOE/NNSA currently certified Type B package(s). |           |
|     | If no candidate packaging is identified, the       |           |
|     | screening process should be terminated and a       |           |
|     | determination on whether the applicant should      |           |
|     | pursue the design, development, certification and  |           |
|     | procurement of a new package will be made. If      |           |
|     | candidate packaging(s) are identified, the         |           |
|     | screening can continue.                            |           |
+-----+----------------------------------------------------+-----------+
| 3   | Works with the applicant and the SARP owner of the |           |
|     | candidate packaging to provide/identify the        |           |
|     | funding and to develop schedule needed by the SARP |           |
|     | owner to perform the criticality, shielding and    |           |
|     | structural analysis.                               |           |
+-----+----------------------------------------------------+-----------+
| 4   | Authorizes the SARP owner to perform the           |           |
|     | criticality, shielding and structural analyses     |           |
|     | using the funding provided/identified in the step  |           |
|     | immediately above.                                 |           |
+-----+----------------------------------------------------+-----------+
| 5   | Works with the SARP owner and applicant to         |           |
|     | establish a formal agreement that documents the    |           |
|     | agreed to actions and milestones for each          |           |
|     | participant, and the data and other resources that |           |
|     | the applicant and/or DOE/NNSA line management will |           |
|     | provide for the SARP effort.                       |           |
+-----+----------------------------------------------------+-----------+
| 6   | Provides the additional resources to the SARP      |           |
|     | owner before the SARP owner commences the formal   |           |
|     | work agreed to in the step immediately above.      |           |
+-----+----------------------------------------------------+-----------+
| 7   | Assists the applicant pursue the design,           |           |
|     | development, certification and procurement of a    |           |
|     | new package after it has been determined that the  |           |
|     | content(s) still need to be shipped off site, and  |           |
|     | the packaging of a DOE/NNSA currently certified    |           |
|     | package can not be certified for this use, a       |           |
|     | request for a DOE/NNSA Deputy Administrator for    |           |
|     | Defense Programs exemption that would allow the    |           |
|     | use of an package that can not be certified has    |           |
|     | been denied, or the Federal Site Manager will not  |           |
|     | approve the proposed packaging and shipping        |           |
|     | operations after the DOE/NNSA Deputy Administrator |           |
|     | for Defense Programs has granted an exemption      |           |
+-----+----------------------------------------------------+-----------+

+-----+------------------------------------------------+---------------+
| []  |                                                |               |
| {#A |                                                |               |
| ddi |                                                |               |
| ng_ |                                                |               |
| New |                                                |               |
| _Co |                                                |               |
| nte |                                                |               |
| nt_ |                                                |               |
| SAR |                                                |               |
| P_O |                                                |               |
| wne |                                                |               |
| rs_ |                                                |               |
| Che |                                                |               |
| ckl |                                                |               |
| ist |                                                |               |
| .a  |                                                |               |
| nch |                                                |               |
| or} |                                                |               |
| **S |                                                |               |
| ARP |                                                |               |
| Own |                                                |               |
| er' |                                                |               |
| s** |                                                |               |
|     |                                                |               |
| *   |                                                |               |
| *Ch |                                                |               |
| eck |                                                |               |
| lis |                                                |               |
| t** |                                                |               |
|     |                                                |               |
| P   |                                                |               |
| roc |                                                |               |
| ess |                                                |               |
| for |                                                |               |
| G   |                                                |               |
| ett |                                                |               |
| ing |                                                |               |
| Ap  |                                                |               |
| pro |                                                |               |
| val |                                                |               |
| for |                                                |               |
| Add |                                                |               |
| ing |                                                |               |
| New |                                                |               |
| C   |                                                |               |
| ont |                                                |               |
| ent |                                                |               |
| to  |                                                |               |
| a   |                                                |               |
|     |                                                |               |
| DO  |                                                |               |
| E/N |                                                |               |
| NSA |                                                |               |
| Cur |                                                |               |
| ren |                                                |               |
| tly |                                                |               |
| Cer |                                                |               |
| tif |                                                |               |
| ied |                                                |               |
| T   |                                                |               |
| ype |                                                |               |
| B   |                                                |               |
| P   |                                                |               |
| ack |                                                |               |
| age |                                                |               |
+=====+================================================+===============+
| **  | **Activity**                                   | **Completion  |
| Ste |                                                | Date**        |
| p** |                                                |               |
+-----+------------------------------------------------+---------------+
| 1   | Complies with the applicant's initial          |               |
|     | screening request(s) by using the data package |               |
|     | provided by the applicant and the applicable   |               |
|     | approved SARP, performing the applicable       |               |
|     | analysis, and providing the results to the     |               |
|     | applicant and PCD.                             |               |
+-----+------------------------------------------------+---------------+
| 2   | Consults with the applicant as needed.         |               |
+-----+------------------------------------------------+---------------+
| 3   | Works with the applicant and DOE/NNSA line     |               |
|     | management to secure funding and to develop a  |               |
|     | schedule for any follow-on screening.          |               |
+-----+------------------------------------------------+---------------+
| 4   | Performs and documents analytical work that    |               |
|     | can be used to assess the candidate package's  |               |
|     | viability for the proposed application. This   |               |
|     | analytical work should include analysis on the |               |
|     | candidate package's criticality per 10 CFR 71, |               |
|     | and shielding (or actual proposed content(s)   |               |
|     | dose rate measurements which can be used to    |               |
|     | determine that shielding is not an issue), and |               |
|     | structural viability. The structural analysis  |               |
|     | should be a complete analysis, or at a         |               |
|     | minimum, should be sufficiently comprehensive  |               |
|     | to prove that the proposed configuration(s) is |               |
|     | bounded by the candidate packaging's currently |               |
|     | approved configuration(s).                     |               |
+-----+------------------------------------------------+---------------+
| 5   | Submits the results of the analytical work to  |               |
|     | the applicant and PCD, and continues or        |               |
|     | terminates the process based on guidance       |               |
|     | provided by the applicant and PCD.             |               |
+-----+------------------------------------------------+---------------+
| 6   | Establishes a formal agreement with the        |               |
|     | applicant that includes the actions and        |               |
|     | milestones that will be used to support the    |               |
|     | need date for the certification of the new     |               |
|     | package, and the funding, data, and/or other   |               |
|     | resources that will be provided to the SARP    |               |
|     | owner to revise the SARP or develop a SARP     |               |
|     | addendum in support of this effort.            |               |
+-----+------------------------------------------------+---------------+
| 7   | Receives the additional resources from the     |               |
|     | applicant and/or DOE/NNSA line management      |               |
|     | before commencing the work stipulated in the   |               |
|     | formal agreement.                              |               |
+-----+------------------------------------------------+---------------+
| 8   | Performs the activities required to support    |               |
|     | the development of the new SARP or SARP        |               |
|     | addendum and associated documents.             |               |
+-----+------------------------------------------------+---------------+
| 9   | Develops a draft SARP/SARP addendum and        |               |
|     | associated documents.                          |               |
+-----+------------------------------------------------+---------------+
| 10  | Submits the SARP/SARP addendum and associated  |               |
|     | documents to the PCD for review, and performs  |               |
|     | the SARP/SARP addendum review activities       |               |
|     | specified in SG 500 [Section                   |               |
|     | 2.2.8](#SARP_Owner).                           |               |
+-----+------------------------------------------------+---------------+
| 11  | Proceeds to [Step 13](#Step_Thirteen) once all |               |
|     | of the comments are resolved, the PCD          |               |
|     | determines that the package meets the          |               |
|     | applicable 10 CFR 71 and 49 CFR 100-185        |               |
|     | requirements, and approves the SARP/SARP       |               |
|     | addendum and associated documents, or          |               |
|     | continues to [Step 12](#Step_Twelve) if the    |               |
|     | PCD determines that the proposed package       |               |
|     | cannot be certified.                           |               |
+-----+------------------------------------------------+---------------+
| []{ | Meets with the applicant to determine the path |               |
| #St | forward based on the formal agreement and      |               |
| ep_ | resources available.                           |               |
| Twe |                                                |               |
| lve |                                                |               |
| .   |                                                |               |
| anc |                                                |               |
| hor |                                                |               |
| }12 |                                                |               |
+-----+------------------------------------------------+---------------+
| []  | Participates in the resolution of the          |               |
| {#S | SARP/SARP addendum and associated documents    |               |
| tep | comments.                                      |               |
| _Th |                                                |               |
| irt |                                                |               |
| een |                                                |               |
| .   |                                                |               |
| anc |                                                |               |
| hor |                                                |               |
| }13 |                                                |               |
+-----+------------------------------------------------+---------------+
| 14  | Comes to consensus with the PCD on the         |               |
|     | SARP/SARP addendum and associated documents    |               |
|     | comments.                                      |               |
+-----+------------------------------------------------+---------------+
| 15  | Publishes and distributes the final (approved) |               |
|     | SARP/SARP addendum to the PCD, applicant and   |               |
|     | other prospective package users.               |               |
+-----+------------------------------------------------+---------------+
| 16  | Prior to the package's recertification, the    |               |
|     | SARP owner must ensure that the revised SARP   |               |
|     | includes this new content(s) if there is still |               |
|     | a need to ship these new content(s) off site.  |               |
+-----+------------------------------------------------+---------------+

+-----+----------------------------------------------------+-----------+
| []  |                                                    |           |
| {#A |                                                    |           |
| ddi |                                                    |           |
| ng_ |                                                    |           |
| New |                                                    |           |
| _Co |                                                    |           |
| nte |                                                    |           |
| nt_ |                                                    |           |
| Oth |                                                    |           |
| er_ |                                                    |           |
| Use |                                                    |           |
| rs_ |                                                    |           |
| Che |                                                    |           |
| ckl |                                                    |           |
| ist |                                                    |           |
| .an |                                                    |           |
| cho |                                                    |           |
| r}* |                                                    |           |
| *Ot |                                                    |           |
| her |                                                    |           |
| Pr  |                                                    |           |
| osp |                                                    |           |
| ect |                                                    |           |
| ive |                                                    |           |
| P   |                                                    |           |
| ack |                                                    |           |
| age |                                                    |           |
| Us  |                                                    |           |
| ers |                                                    |           |
| '** |                                                    |           |
|     |                                                    |           |
| *   |                                                    |           |
| *Ch |                                                    |           |
| eck |                                                    |           |
| lis |                                                    |           |
| t** |                                                    |           |
|     |                                                    |           |
| P   |                                                    |           |
| roc |                                                    |           |
| ess |                                                    |           |
| for |                                                    |           |
| G   |                                                    |           |
| ett |                                                    |           |
| ing |                                                    |           |
| Ap  |                                                    |           |
| pro |                                                    |           |
| val |                                                    |           |
| for |                                                    |           |
| Add |                                                    |           |
| ing |                                                    |           |
| New |                                                    |           |
| C   |                                                    |           |
| ont |                                                    |           |
| ent |                                                    |           |
| to  |                                                    |           |
| a   |                                                    |           |
|     |                                                    |           |
| DO  |                                                    |           |
| E/N |                                                    |           |
| NSA |                                                    |           |
| Cur |                                                    |           |
| ren |                                                    |           |
| tly |                                                    |           |
| Cer |                                                    |           |
| tif |                                                    |           |
| ied |                                                    |           |
| T   |                                                    |           |
| ype |                                                    |           |
| B   |                                                    |           |
| P   |                                                    |           |
| ack |                                                    |           |
| age |                                                    |           |
+-----+----------------------------------------------------+-----------+
| **  | **Activity**                                       | **C       |
| Ste |                                                    | ompletion |
| p** |                                                    | Date**    |
+-----+----------------------------------------------------+-----------+
| 1   | Begin the development of their packaging quality   |           |
|     | assurance plan that complies with the requirements |           |
|     | of 10 CFR 71 Subpart H, and their review, and, if  |           |
|     | required, revision of the Site's quality assurance |           |
|     | plan.                                              |           |
+-----+----------------------------------------------------+-----------+
| 1.a | For certified packages, the packaging quality      |           |
|     | assurance plan must comply with all of the         |           |
|     | requirements of 10 CFR 71 Subpart H.               |           |
+-----+----------------------------------------------------+-----------+
| 1.b | For packaging authorized under a DOE/NNSA Deputy   |           |
|     | Administrator for Defense Programs exemption: work |           |
|     | with PCD to get their approval for the packaging   |           |
|     | quality assurance plans' format and content. [Do   |           |
|     | not proceed with any subsequent process steps      |           |
|     | unless]{.underline} the DOE/NNSA Deputy            |           |
|     | Administrator for Defense Programs grants the      |           |
|     | exemption.                                         |           |
+-----+----------------------------------------------------+-----------+
| 2   | Submit their packaging quality assurance plan to   |           |
|     | PCD for approval.                                  |           |
+-----+----------------------------------------------------+-----------+
| 3   | Ensure that the Site receives a copy of the        |           |
|     | SARP/SARP addendum, and the DOE/NNSA Deputy        |           |
|     | Administrator for Defense Programs exemption, if   |           |
|     | applicable.                                        |           |
+-----+----------------------------------------------------+-----------+
| 4   | Publish and distribute the approved packaging      |           |
|     | quality assurance plan.                            |           |
+-----+----------------------------------------------------+-----------+
| 5   | Start the development of draft packaging           |           |
|     | procedures that are based on the SARP/SARP         |           |
|     | addendum, OTC/OTA restrictions, and the DOE/NNSA   |           |
|     | Deputy Administrator for Defense Programs          |           |
|     | exemption, if applicable.                          |           |
+-----+----------------------------------------------------+-----------+
| 6   | Submit the draft packaging procedures and the      |           |
|     | associated Site quality assurance plan to the PCD  |           |
|     | for review and approval, and supports the review   |           |
|     | process as specified in SG 500 [Section            |           |
|     | 2.2.1                                              |           |
|     | 4.L.3](#OTA_OTC_Users_Pkg_Procedures_and_QA_Plan). |           |
+-----+----------------------------------------------------+-----------+
| 7   | Publish and disseminate copies of the approved     |           |
|     | packaging procedures and Site quality assurance    |           |
|     | plan (if revisions are made).                      |           |
+-----+----------------------------------------------------+-----------+
| 8   | Ensure that their Site receives a copy of the new  |           |
|     | OTC/OTA and SER.                                   |           |
+-----+----------------------------------------------------+-----------+
| 9   | Check the DOE/NNSA OTA/OTC Web Page to verify that |           |
|     | their Site is an authorized user for this package. |           |
|     | Contact the PCD if their Site is not listed as an  |           |
|     | authorized user of this package, but should be     |           |
|     | listed.                                            |           |
+-----+----------------------------------------------------+-----------+
| 10  | Do not commence packaging operations that must be  |           |
|     | performed under a DOE/NNSA Deputy Administrator    |           |
|     | for Defense Programs exemption until their Site    |           |
|     | has implemented all of the requirements specified  |           |
|     | in the DOE/NNSA Deputy Administrator for Defense   |           |
|     | Programs exemption and the Federal Site Manager    |           |
|     | has authorized their Site to proceed with these    |           |
|     | operations.                                        |           |
+-----+----------------------------------------------------+-----------+
| 11  | Commence packaging operations with the newly       |           |
|     | certified package or the packaging authorized      |           |
|     | under a DOE/NNSA Deputy Administrator for Defense  |           |
|     | Programs exemption, as applicable, using the       |           |
|     | approved packaging procedures, SARP/SARP addendum, |           |
|     | OTC/OTA, SER, and if applicable the DOE/NNSA       |           |
|     | Deputy Administrator for Defense Programs          |           |
|     | exemption instructions and restrictions and/or     |           |
|     | guidance provided by the applicant's Federal Site  |           |
|     | Manager.                                           |           |
+-----+----------------------------------------------------+-----------+
| 12  | Submit a transportation services request to the    |           |
|     | Office of Secure Transportation, in accordance     |           |
|     | with the Office of Secure Transportation           |           |
|     | prescribed format, to request and schedule         |           |
|     | off-site transportation services.                  |           |
+-----+----------------------------------------------------+-----------+
| 13  | Commence shipping operations as prescribed in      |           |
|     | SARP/SARP addendum, OTC/OTA, SER, and if           |           |
|     | applicable the DOE/NNSA Deputy Administrator for   |           |
|     | Defense Programs exemption instructions and        |           |
|     | restrictions and/or guidance provided by the       |           |
|     | applicant's Federal Site Manager.                  |           |
+-----+----------------------------------------------------+-----------+

+-----+--------------------------------------------------+-------------+
| [   |                                                  |             |
| ]{# |                                                  |             |
| Add |                                                  |             |
| ing |                                                  |             |
| _Ne |                                                  |             |
| w_C |                                                  |             |
| ont |                                                  |             |
| ent |                                                  |             |
| _DA |                                                  |             |
| DP_ |                                                  |             |
| Che |                                                  |             |
| ckl |                                                  |             |
| ist |                                                  |             |
| .   |                                                  |             |
| anc |                                                  |             |
| hor |                                                  |             |
| }** |                                                  |             |
| Off |                                                  |             |
| ice |                                                  |             |
| of  |                                                  |             |
| the |                                                  |             |
| DO  |                                                  |             |
| E/N |                                                  |             |
| NSA |                                                  |             |
| Dep |                                                  |             |
| uty |                                                  |             |
| A   |                                                  |             |
| dmi |                                                  |             |
| nis |                                                  |             |
| tra |                                                  |             |
| tor |                                                  |             |
| for |                                                  |             |
| D   |                                                  |             |
| efe |                                                  |             |
| nse |                                                  |             |
| Pr  |                                                  |             |
| ogr |                                                  |             |
| ams |                                                  |             |
| '** |                                                  |             |
|     |                                                  |             |
| *   |                                                  |             |
| *Ch |                                                  |             |
| eck |                                                  |             |
| lis |                                                  |             |
| t** |                                                  |             |
|     |                                                  |             |
| P   |                                                  |             |
| roc |                                                  |             |
| ess |                                                  |             |
| for |                                                  |             |
| G   |                                                  |             |
| ett |                                                  |             |
| ing |                                                  |             |
| Ap  |                                                  |             |
| pro |                                                  |             |
| val |                                                  |             |
| for |                                                  |             |
| Add |                                                  |             |
| ing |                                                  |             |
| New |                                                  |             |
| C   |                                                  |             |
| ont |                                                  |             |
| ent |                                                  |             |
| to  |                                                  |             |
| a   |                                                  |             |
|     |                                                  |             |
| DO  |                                                  |             |
| E/N |                                                  |             |
| NSA |                                                  |             |
| Cur |                                                  |             |
| ren |                                                  |             |
| tly |                                                  |             |
| Cer |                                                  |             |
| tif |                                                  |             |
| ied |                                                  |             |
| T   |                                                  |             |
| ype |                                                  |             |
| B   |                                                  |             |
| P   |                                                  |             |
| ack |                                                  |             |
| age |                                                  |             |
+-----+--------------------------------------------------+-------------+
| **  | **Activity**                                     | *           |
| Ste |                                                  | *Completion |
| p** |                                                  | Date**      |
+-----+--------------------------------------------------+-------------+
| 1   | Reviews the exemption request, and based on the  |             |
|     | results of its review of the analysis and        |             |
|     | documentation provided in the request, its own   |             |
|     | independent analysis, the exemption criteria of  |             |
|     | DOE Order 461.1A, and the recommendations        |             |
|     | provided by the other exemption request          |             |
|     | reviewers, grants or denies the exemption        |             |
|     | request.                                         |             |
+-----+--------------------------------------------------+-------------+
| 1.a | If the exemption request is denied, the          |             |
|     | correspondence which communicates the denial     |             |
|     | should indicate whether the exemption request    |             |
|     | would be reconsidered if additional              |             |
|     | information/data were provided or whether the    |             |
|     | applicant should seek another solution for       |             |
|     | packaging the proposed content(s) (i.e.,         |             |
|     | initiate a new packaging design).                |             |
+-----+--------------------------------------------------+-------------+
| 1.b | If the exemption is granted, the correspondence  |             |
|     | that issues the exemption should be addressed to |             |
|     | the Federal Site Manager of the applicant's      |             |
|     | Site, copy to the applicant, the NNSA Service    |             |
|     | Center Manager, and all other organizations to   |             |
|     | which the exemption applies, and should provide  |             |
|     | exemption-implementing instructions, if          |             |
|     | applicable.                                      |             |
+-----+--------------------------------------------------+-------------+

+-----+--------------------------------------------------+-------------+
| []{ |                                                  |             |
| #Ad |                                                  |             |
| din |                                                  |             |
| g_N |                                                  |             |
| ew_ |                                                  |             |
| Con |                                                  |             |
| ten |                                                  |             |
| t_P |                                                  |             |
| CD_ |                                                  |             |
| Che |                                                  |             |
| ckl |                                                  |             |
| ist |                                                  |             |
| .an |                                                  |             |
| cho |                                                  |             |
| r}* |                                                  |             |
| *DO |                                                  |             |
| E/N |                                                  |             |
| NSA |                                                  |             |
| S   |                                                  |             |
| erv |                                                  |             |
| ice |                                                  |             |
| Ce  |                                                  |             |
| nte |                                                  |             |
| r's |                                                  |             |
| Pac |                                                  |             |
| kag |                                                  |             |
| ing |                                                  |             |
| C   |                                                  |             |
| ert |                                                  |             |
| ifi |                                                  |             |
| cat |                                                  |             |
| ion |                                                  |             |
| Div |                                                  |             |
| isi |                                                  |             |
| on' |                                                  |             |
| s** |                                                  |             |
|     |                                                  |             |
| *   |                                                  |             |
| *Ch |                                                  |             |
| eck |                                                  |             |
| lis |                                                  |             |
| t** |                                                  |             |
|     |                                                  |             |
| P   |                                                  |             |
| roc |                                                  |             |
| ess |                                                  |             |
| for |                                                  |             |
| G   |                                                  |             |
| ett |                                                  |             |
| ing |                                                  |             |
| Ap  |                                                  |             |
| pro |                                                  |             |
| val |                                                  |             |
| for |                                                  |             |
| Add |                                                  |             |
| ing |                                                  |             |
| New |                                                  |             |
| C   |                                                  |             |
| ont |                                                  |             |
| ent |                                                  |             |
| to  |                                                  |             |
| a   |                                                  |             |
|     |                                                  |             |
| DO  |                                                  |             |
| E/N |                                                  |             |
| NSA |                                                  |             |
| Cur |                                                  |             |
| ren |                                                  |             |
| tly |                                                  |             |
| Cer |                                                  |             |
| tif |                                                  |             |
| ied |                                                  |             |
| T   |                                                  |             |
| ype |                                                  |             |
| B   |                                                  |             |
| P   |                                                  |             |
| ack |                                                  |             |
| age |                                                  |             |
+=====+==================================================+=============+
| **  | **Activity**                                     | *           |
| Ste |                                                  | *Completion |
| p** |                                                  | Date**      |
+-----+--------------------------------------------------+-------------+
| 1   | Supports SARP owners and applicants as needed.   |             |
+-----+--------------------------------------------------+-------------+
| 2   | Uses the information on the proposed content(s)  |             |
|     | provided by the applicant and the SARP owner's   |             |
|     | documentation of the results of the analytical   |             |
|     | work on criticality, shielding and structural to |             |
|     | assess the candidate packaging's viability for   |             |
|     | certification and notifies the SARP owner,       |             |
|     | applicant, DOE/NNSA Certifying Official, and     |             |
|     | DOE/NNSA Service Center management of the        |             |
|     | determination. If the PCD determines that the    |             |
|     | candidate packaging is a viable candidate for    |             |
|     | certification the process should continue,       |             |
|     | otherwise the process should stop.               |             |
+-----+--------------------------------------------------+-------------+
| 3   | Determines whether the application for           |             |
|     | certification should be supported by a SARP or a |             |
|     | SARP addendum and notifies the SARP owner and    |             |
|     | the applicant.                                   |             |
+-----+--------------------------------------------------+-------------+
| 4   | Performs review/confirmatory analysis of         |             |
|     | SARP/SARP addendum and develops comments based   |             |
|     | in the review/confirmatory analysis as specified |             |
|     | in SG 500 [Sections                              |             |
|     | 2                                                |             |
|     | .2.3](#PCD_Mgr_Pkg_Cert_and_Ship_Authoriz_respo) |             |
|     | and                                              |             |
|     | [2.2                                             |             |
|     | .3.1](#CE_Pkg_Cert_and_Ship_Authoriz_responsibi) |             |
|     | and Appendix A, and keeps the DOE/NNSA           |             |
|     | Certifying Official and DOE/NNSA Service Center  |             |
|     | management informed of project status, project   |             |
|     | delays and/or any project difficulties.          |             |
+-----+--------------------------------------------------+-------------+
| 5   | Through its SARP/SARP addendum review and        |             |
|     | responses from the SARP owner, determines that   |             |
|     | the proposed package meets or doesn't meet the   |             |
|     | applicable 10 CFR 71 and 49 CFR 100-185          |             |
|     | requirements and can or cannot be certified.     |             |
+-----+--------------------------------------------------+-------------+
| 6   | Notifies the SARP owner, applicant, DOE/NNSA     |             |
|     | Certifying Official that the proposed package    |             |
|     | can or cannot be certified.                      |             |
+-----+--------------------------------------------------+-------------+
| 7   | If the proposed package can be certified proceed |             |
|     | to [Step 9](#Step_Nine), otherwise continue to   |             |
|     | Step 8.                                          |             |
+-----+--------------------------------------------------+-------------+
| 8   | If the proposed package cannot be certified, but |             |
|     | the applicant applies for a DOE/NNSA Deputy      |             |
|     | Administrator for Defense Programs exemption:    |             |
+-----+--------------------------------------------------+-------------+
| 8.a | Reviews the applicant's exemption request and    |             |
|     | provides recommendation for approval/disapproval |             |
|     | to the DOE/NNSA Deputy Administrator for Defense |             |
|     | Programs via the DOE/NNSA Certifying Official    |             |
|     | and the DOE/NNSA Service Center Manager.         |             |
+-----+--------------------------------------------------+-------------+
| 8.b | Terminates all activities on this project if the |             |
|     | DOE/NNSA Deputy Administrator for Defense        |             |
|     | Programs denies the exemption request. Continues |             |
|     | the process if the DOE/NNSA Deputy Administrator |             |
|     | for Defense Programs grants the exemption        |             |
|     | request.                                         |             |
+-----+--------------------------------------------------+-------------+
| 8.c | Works with applicant and other perspective users |             |
|     | of packaging authorized under a DOE/NNSA Deputy  |             |
|     | Administrator for Defense Programs exemption and |             |
|     | approves the format and content of their         |             |
|     | packaging quality assurance plans.               |             |
+-----+--------------------------------------------------+-------------+
| [   | Resolves all of the draft SARP/SARP addendum     |             |
| ]{# | review comments, and approves the draft          |             |
| Ste | SARP/SARP addendum. If the PCD and the SARP      |             |
| p_N | owner are unable to resolve the SARP/SARP        |             |
| ine | addendum review comments, the issues may be      |             |
| .an | presented to DOE/NNSA upper management for       |             |
| cho | resolution.                                      |             |
| r}9 |                                                  |             |
+-----+--------------------------------------------------+-------------+
| 10  | Review the applicant's and other perspective     |             |
|     | users' draft packaging quality assurance plans:  |             |
+-----+--------------------------------------------------+-------------+
| 1   | For certified packages: approve if the plans are |             |
| 0.a | in compliance with the 10 CFR 71 Subpart H       |             |
|     | requirements.                                    |             |
+-----+--------------------------------------------------+-------------+
| 1   | For packaging authorized under a DOE/NNSA Deputy |             |
| 0.b | Administrator for Defense Programs exemption:    |             |
|     | approve if the format and content are in         |             |
|     | compliance with the format and content approved  |             |
|     | earlier.                                         |             |
+-----+--------------------------------------------------+-------------+
| 11  | Develops additional, if applicable, packaging    |             |
|     | and shipping restrictions for inclusion in the   |             |
|     | OTC/OTA and communicates them to the applicant   |             |
|     | and other prospective package users.             |             |
+-----+--------------------------------------------------+-------------+
| 12  | Uses the final SARP/SARP addendum to develop a   |             |
|     | draft OTC for certifying the new package, or the |             |
|     | final SARP/SARP addendum and the DOE/NNSA Deputy |             |
|     | Administrator for Defense Programs exemption to  |             |
|     | develop a draft OTC or OTA for authorizing the   |             |
|     | use of packaging approved under a DOE/NNSA       |             |
|     | Deputy Administrator for Defense Programs        |             |
|     | exemption, and the associated SER and            |             |
|     | distribution memorandum.                         |             |
+-----+--------------------------------------------------+-------------+
| 13  | Submits the OTC/OTA, SER and distribution        |             |
|     | memorandum to the DOE/NNSA Certifying Official   |             |
|     | for approval. Proceeds as specified in SG 500    |             |
|     | [Section                                         |             |
|     | 2.2.3.1.B.4.c.(4)](#CE_SER_OTC_OTA_Prep) if the  |             |
|     | DOE/NNSA Certifying Official disapproves the     |             |
|     | SER, OTC/OTA or distribution memorandum.         |             |
+-----+--------------------------------------------------+-------------+
| 14  | Distributes the approved OTC/OTA, SER and        |             |
|     | distribution memorandum to DOE/NNSA              |             |
|     | Headquarters, applicant, SARP owner, Office of   |             |
|     | Secure Transportation, and other prospective     |             |
|     | package users.                                   |             |
+-----+--------------------------------------------------+-------------+
| 15  | Processes the Sites'/other prospective user'(s)  |             |
|     | draft packaging procedures and associated Site   |             |
|     | quality assurance plans as specified in SG 500   |             |
|     | [Section                                         |             |
|     | 2.2.3.1.B.4.                                     |             |
|     | c.(1)](#CE_Review_of_PkgProcedures_and_QA_Plan). |             |
|     | If the draft packaging procedures and quality    |             |
|     | assurance plan are approved the process          |             |
|     | continues. Otherwise the review and approval     |             |
|     | process stops until the issues are resolved.     |             |
+-----+--------------------------------------------------+-------------+
| 16  | Updates the DOE/NNSA OTA/OTC Web Page.           |             |
+-----+--------------------------------------------------+-------------+

+-----+--------------------------------------------------+-------------+
| []  |                                                  |             |
| {#A |                                                  |             |
| ddi |                                                  |             |
| ng_ |                                                  |             |
| New |                                                  |             |
| _Co |                                                  |             |
| nte |                                                  |             |
| nt_ |                                                  |             |
| Cer |                                                  |             |
| t_O |                                                  |             |
| ffi |                                                  |             |
| cia |                                                  |             |
| ls_ |                                                  |             |
| Che |                                                  |             |
| ckl |                                                  |             |
| .an |                                                  |             |
| cho |                                                  |             |
| r}* |                                                  |             |
| *DO |                                                  |             |
| E/N |                                                  |             |
| NSA |                                                  |             |
| C   |                                                  |             |
| ert |                                                  |             |
| ify |                                                  |             |
| ing |                                                  |             |
| Off |                                                  |             |
| ici |                                                  |             |
| al' |                                                  |             |
| s** |                                                  |             |
|     |                                                  |             |
| *   |                                                  |             |
| *Ch |                                                  |             |
| eck |                                                  |             |
| lis |                                                  |             |
| t** |                                                  |             |
|     |                                                  |             |
| P   |                                                  |             |
| roc |                                                  |             |
| ess |                                                  |             |
| for |                                                  |             |
| G   |                                                  |             |
| ett |                                                  |             |
| ing |                                                  |             |
| Ap  |                                                  |             |
| pro |                                                  |             |
| val |                                                  |             |
| for |                                                  |             |
| Add |                                                  |             |
| ing |                                                  |             |
| New |                                                  |             |
| C   |                                                  |             |
| ont |                                                  |             |
| ent |                                                  |             |
| to  |                                                  |             |
| a   |                                                  |             |
|     |                                                  |             |
| DO  |                                                  |             |
| E/N |                                                  |             |
| NSA |                                                  |             |
| Cur |                                                  |             |
| ren |                                                  |             |
| tly |                                                  |             |
| Cer |                                                  |             |
| tif |                                                  |             |
| ied |                                                  |             |
| T   |                                                  |             |
| ype |                                                  |             |
| B   |                                                  |             |
| P   |                                                  |             |
| ack |                                                  |             |
| age |                                                  |             |
+-----+--------------------------------------------------+-------------+
| **  | **Activity**                                     | *           |
| Ste |                                                  | *Completion |
| p** |                                                  | Date**      |
+-----+--------------------------------------------------+-------------+
| 1   | If the proposed package is certifiable:          |             |
+-----+--------------------------------------------------+-------------+
| 1.a | Reviews the draft OTC, SER and distribution      |             |
|     | memorandum.                                      |             |
+-----+--------------------------------------------------+-------------+
| 1.b | Certifies the new package by approving the draft |             |
|     | OTC, SER and distribution memorandum and signing |             |
|     | the OTC and distribution memorandum, or          |             |
|     | disapproves the new package's certification.     |             |
|     | Identifies the reason for the disapproval and    |             |
|     | provides the PCD instructions on how to proceed  |             |
|     | if the OTC, SER or distribution memorandum is    |             |
|     | disapproved.                                     |             |
+-----+--------------------------------------------------+-------------+
| 2   | If the proposed package is not certifiable and   |             |
|     | the applicant requests an exemption from the     |             |
|     | DOE/NNSA Deputy Administrator for Defense        |             |
|     | Programs:                                        |             |
+-----+--------------------------------------------------+-------------+
| 2.a | Reviews the applicant's exemption request and    |             |
|     | provides recommendation for approval/disapproval |             |
|     | to the DOE/NNSA Deputy Administrator for Defense |             |
|     | Programs.                                        |             |
+-----+--------------------------------------------------+-------------+
| 3   | If the DOE/NNSA Deputy Administrator for Defense |             |
|     | Programs grants the exemption:                   |             |
+-----+--------------------------------------------------+-------------+
| 3.a | Reviews the draft OTC/OTA, SER and distribution  |             |
|     | memorandum.                                      |             |
+-----+--------------------------------------------------+-------------+
| 3.b | Approves/disapproves the OTC/OTA, SER or         |             |
|     | distribution memorandum. Identifies the reason   |             |
|     | for the disapproval and provides the PCD         |             |
|     | instructions on how to proceed if the OTC/OTA,   |             |
|     | SER or distribution memorandum is disapproved,.  |             |
+-----+--------------------------------------------------+-------------+

+-----+--------------------------------------------------+-------------+
| []  |                                                  |             |
| {#A |                                                  |             |
| ddi |                                                  |             |
| ng_ |                                                  |             |
| New |                                                  |             |
| _Co |                                                  |             |
| nte |                                                  |             |
| nt_ |                                                  |             |
| Fed |                                                  |             |
| _Si |                                                  |             |
| te_ |                                                  |             |
| MGR |                                                  |             |
| _Ch |                                                  |             |
| eck |                                                  |             |
| lis |                                                  |             |
| .a  |                                                  |             |
| nch |                                                  |             |
| or} |                                                  |             |
| **F |                                                  |             |
| ede |                                                  |             |
| ral |                                                  |             |
| S   |                                                  |             |
| ite |                                                  |             |
| Ma  |                                                  |             |
| nag |                                                  |             |
| er' |                                                  |             |
| s** |                                                  |             |
|     |                                                  |             |
| *   |                                                  |             |
| *Ch |                                                  |             |
| eck |                                                  |             |
| lis |                                                  |             |
| t** |                                                  |             |
|     |                                                  |             |
| P   |                                                  |             |
| roc |                                                  |             |
| ess |                                                  |             |
| for |                                                  |             |
| G   |                                                  |             |
| ett |                                                  |             |
| ing |                                                  |             |
| Ap  |                                                  |             |
| pro |                                                  |             |
| val |                                                  |             |
| for |                                                  |             |
| Add |                                                  |             |
| ing |                                                  |             |
| New |                                                  |             |
| C   |                                                  |             |
| ont |                                                  |             |
| ent |                                                  |             |
| to  |                                                  |             |
| a   |                                                  |             |
|     |                                                  |             |
| DO  |                                                  |             |
| E/N |                                                  |             |
| NSA |                                                  |             |
| Cur |                                                  |             |
| ren |                                                  |             |
| tly |                                                  |             |
| Cer |                                                  |             |
| tif |                                                  |             |
| ied |                                                  |             |
| T   |                                                  |             |
| ype |                                                  |             |
| B   |                                                  |             |
| P   |                                                  |             |
| ack |                                                  |             |
| age |                                                  |             |
+-----+--------------------------------------------------+-------------+
| **  | **Activity**                                     | *           |
| Ste |                                                  | *Completion |
| p** |                                                  | Date**      |
+-----+--------------------------------------------------+-------------+
| 1   | Works with site (applicant) to determine whether |             |
|     | the item must be shipped off site. If the        |             |
|     | determination indicates that the item must be    |             |
|     | shipped off site, this process should continue.  |             |
|     | Otherwise the process should end.                |             |
+-----+--------------------------------------------------+-------------+
| 2   | If the proposed package is certified, provides   |             |
|     | oversight of packaging and off-site              |             |
|     | transportation associated activities at the      |             |
|     | Site.                                            |             |
+-----+--------------------------------------------------+-------------+
| 3   | If the package is not certified, and the         |             |
|     | decision is made to submit an exemption request  |             |
|     | to the DOE/NNSA Deputy Administrator for Defense |             |
|     | Programs, review the applicant's exemption       |             |
|     | request and provide recommendation for           |             |
|     | approval/disapproval to the DOE/NNSA Deputy      |             |
|     | Administrator for Defense Programs.              |             |
+-----+--------------------------------------------------+-------------+
| 4   | If the DOE/NNSA Deputy Administrator for Defense |             |
|     | Programs grants the exemption:                   |             |
+-----+--------------------------------------------------+-------------+
| 4.a | Implements the exemption and its implementation  |             |
|     | instructions, and ensures that the applicable    |             |
|     | contractor(s) under his/her cognizance comply    |             |
|     | with the exemption and its implementation        |             |
|     | instructions.                                    |             |
+-----+--------------------------------------------------+-------------+
| 4.b | Exercises final authority for authorizing/not    |             |
|     | authorizing the shipment(s) after all other      |             |
|     | documents and processes have been approved.      |             |
+-----+--------------------------------------------------+-------------+
| 4.b | Disapproves the proposed packaging and shipment  |             |
| (1) | and advises the applicant on how to proceed, and |             |
|     | the DOE/NNSA Deputy Administrator for Defense    |             |
|     | Programs, PCD, and other prospective users of    |             |
|     | the decision; or,                                |             |
+-----+--------------------------------------------------+-------------+
| 4.b | [Authorizes]{.underline} the packaging and       |             |
| (2) | shipment of the content(s) and provides          |             |
|     | oversight of the activities.                     |             |
+-----+--------------------------------------------------+-------------+

**3.5.3.4** []{#Apply_for_Recert_W_Sig_Design_Changes .anchor}**Process
for Applying for and Processing Recertification Applications for
Currently Certified Type B Packages with Significant Design Changes**

The SARP owner must prepare this package certification application the
same as he/she would prepare an application for any other package that
hasn't been certified. Refer to [Sections 2.2.8](#SARP_Owner) and/or
[2.2.12](#sarptsra-development-organization), as applicable, for
guidance on SARP development, and [Appendix A Section
3.2](#Timelines_for_recert_reauthorization) for information on SARP
review process steps and timelines.

4.  []{#NELAs_Containing_Type_B_RAM .anchor}**Nuclear Weapon Program
    Special Assemblies Containing**

**Type B Quantity RAM**

For shipments of nuclear weapon special assemblies that contain Type B
quantities of RAM, the applicant shall apply for an OTA by submitting an
application that is supported by a TSRA. The application must also
submit a copy of the written authorization, granted by the senior
DOE/NNSA Headquarters nuclear weapons program line manager who has
responsibility for granting this approval to build and test the special
assembly that is addressed in the application. This authorization must
be granted before PCD will accept a request to review the TSRA. See
Appendix B for guidance for developing TSRAs for special assemblies.

**3.5.5** []{#Type_B_Packages_Certified_Under_CofCs .anchor}**Type B
Packages Certified Under DOE CofCs**

If the proposed contents and configurations match the authorized
contents and configurations of packages certified by the DOE
Certification Office (EM-5), there is packaging reciprocity between the
DOE Certification Office and the NNSA Approval Authority for packaging
certification and shipment authorizations. The user of these packages
must have DOE approved packaging procedures and a DOE/NNSA approved
quality assurance plan.

**3.5.6** []{#Packages_Certified_by_NRC_IAEA_DOT .anchor}**Type B
Package Certified Under NRC or IAEA/DOT CofCA Transported in TSS**

The prospective applicant must be an authorized NRC licensee. The
proposed NNSA user/applicant of Type B Package certified under an NRC or
IAEA/DOT CofCA must submit a request to PCD and OST via the Package Line
Manager/Weapon System Program Manager requesting authorization to
transport the NRC or IAEA/DOT CoCA package in the TSS. The applicant and
the Package Line Manager/Weapon System Program Manager must understand
that DOE/NNSA cannot issue revisions to NRC or IAEA/DOT CofCAs or their
certified packagings. The only viable alternative would be for the
applicant to submit a SARP that would be reviewed by a TSRP. The
applicant's request to ship a NRC or IAEA/DOT package under a valid
CofCA in the TSS must comply with the CofCA requirements and applicable
federal regulations, and must provide the documentation needed to
validate the packages compatibility with the TSS loading, unloading,
tiedown and any other specified requirements. The PCD Manager shall
assign a CE or TSRP to evaluate the package's compliance with 10 CFR 71
and 49 CFR 173 requirements, and to assess the adequacy of the NRC or
IAEA/DOT package's safety documentation and the package by conducting or
managing an independent confirmatory technical assessment . This review
shall consist of the validation of the proper use of the packaging for
the application intended. The PCD shall assure that the proposed
configuration is within maintenance and serviceability dates, and that
it can be delivered within the prescribed deadlines. PCD shall issue a
memorandum to OST that documents the results of the review. The CE shall
also work with OST to ensure that the package is compatible with TSS
equipment and the tiedown procedures are contained in either TP 45-51D,
DOE Tiedown Manuals or approved in a separate correspondence from OST to
PCD before an OTC/OTA is issued.

**3.5.7** []{#MOD_UK_Certified .anchor}**Type B Package Certified by UK
MOD Transported in TSS**

The Weapon System Program Manager shall submit a request for
authorization to transport Type B Package certified by UK MOD in the TSS
to PCD and OST. The PCD Manager shall assign a CE or TSRP to evaluate
the proposed UK MOD Type B package's compliance with 10 CFR 71 and 49
CFR 173 requirements, and to assess the adequacy of the UK MOD's safety
documentation and the package by conducting or managing an independent
confirmatory technical assessment. This review shall consist of
validation of the proper use of the packaging for the application
intended. The PCD shall assure that the proposed configuration is within
maintenance and serviceability dates, and can be delivered within
prescribed deadlines. Reviews of DOE/NNSA users operating procedures are
completed in accordance with work process defined for US origin Type B
packaging designs. The CE shall also work with OST to ensure that the
package is compatible with TSS equipment and that the tiedown procedures
are contained in TP 45-51D, Technical Manual, Tiedown Procedures for
Type-B Containers Shipped in Safe-Secure Trailer/Safeguards Transporter
(SST/SGT), DOE/OST Tiedown Manuals or approved in a separate
correspondence from OST to PCD before an OTC/OTA is issued.

### 3.6 Revocation of Authorization to Use Type B Package  {#revocation-of-authorization-to-use-type-b-package .TextBold .unnumbered}

Revocation of a certificate for a specific shipper or class of shippers
may occur if any of the following situations arises:

**A.** Failure of the packaging.

**B.** Disclosure that the currently certified package fails to meet the
applicable regulatory requirements (requirements in effect when the
package was first designed and certified).

**C.** User violates the OTC.

**D.** User violates the associated SARP.

**E.** Use of packaging to package something other than the authorized
content.

**F.** Violation of shipment loading limits.

**G.** Changes in the regulations or the law that would invalidate the
certification. Noncompliance with the DOE-approved QAPP that conforms to
10 CFR 71 Subpart H.

### 3.7 Authorization of Shipping Conveyances  {#authorization-of-shipping-conveyances .TextBold .unnumbered}

Only OST owned and operated vehicles or other vehicles authorized by the
OST, as provided in DOE Order 461.1A, are authorized for off site
transport of nuclear weapon components, Category I and II special
nuclear materials, nuclear weapon program special assemblies, and other
materials of national security interest.

### 3.8 Identification and Control of Items {#identification-and-control-of-items .TextBold .unnumbered}

The users of the DOE/NNSA Service Center Package Certification and
Offsite Transportation Authorization products and services should
maintain quality assurance programs that provide for a management system
that establishes and implements methods to identify, maintain, and
control items and activities and to prohibit the use of incorrect or
unidentified items.

When required, physical identification of items should be used to the
maximum extent possible. Identifying markings should be permanent and
legible and should not adversely affect the function, service, or
archival life of the item. When identification directly on the item is
impractical, physical segregation, record traceability, or other
tracking methods should be described in procedures. When applicable and
safe, each part or piece of an item, when removed from the sample lot,
should have a unique identifier affixed.

### 3.9 Handling, Storing, and Shipping {#handling-storing-and-shipping .TextBold .unnumbered}

The users of the DOE/NNSA Service Center Package Certification and
Offsite Transportation Authorization products and services should
maintain quality assurance programs that define the basic requirements
for a system of controls to ensure that packagings are handled, stored,
shipped, cleaned, and preserved to prevent deterioration or damage.
These controls are established according to instructions,
specifications, drawings, and technical manuals for items that are
sensitive, have a high cost, or have been identified as having a
significant impact on the environment, public, employees, cost or
schedule.

Handling, storage, and shipping of items, (e.g., nuclear components and
special assemblies) should be conducted in accordance with established
procedures specified for use in conducting the activity.

All items to be shipped should be processed by appropriately qualified
personnel. The cognizant individual should assure that documentation
(e.g., carrier shipping forms, chain-of-custody forms, labels, property
release forms) is prepared and if required, signed by the appropriate
person(s).

Shipping documentation should accurately reflect tag and serial numbers
for tagged items. Traceability should be maintained at all times for the
items to be shipped, from the point of origination to the final receipt
of the item or material.

Offsite transportation should be conducted in accordance with local,
state, and federal regulations.

Measures should be established and documented to control handling,
storage, and shipping, including cleaning, packaging, and preservation
of material and equipment in accordance with established instructions,
procedures, or drawings to prevent damage, deterioration, and loss. When
necessary for particular items, special coverings, special equipment,
and special protective environments such as inert gas atmosphere,
specific moisture content levels, and temperature levels should be
specified, provided, and their existence verified.

For critical, sensitive, perishable, or high-value articles, specific
written procedures for handling, storage, packaging, shipping, and
preservation should be used. Special handling tools and equipment should
be provided and controlled to ensure safe and adequate handling.

Special handling tools and equipment should be inspected and tested in
accordance with written procedures and at specified times to verify that
the tools and equipment are adequately maintained.

Special attention should be given to providing adequate instruction for
marking and labeling for packaging, shipment, and storage of items.
Marking should be adequate to identify, maintain, and preserve the
shipment, including indication of the presence of special environments
or the need for special control. DOT regulations provide the necessary
instructions for marking and labeling.

### A. Special Handling Equipment  {#a.-special-handling-equipment .TextBold .unnumbered}

When required for nuclear components and special assemblies, special
equipment (such as containers, fork lifts, shock absorbers, and
accelerometers), special protective environments (such as inert gas
atmosphere), and specific moisture content levels and temperature levels
should be specified and provided, and the condition of each item should
be verified and documented.

### B. Packaging/Shipment {#b.-packagingshipment .TextBold .unnumbered}

Requirements should be specified for protection of a packaging/shipment
against corrosion, contamination, physical damage, or any effect that
would negatively impact the packaging/shipment or cause deterioration
during the time it is handled, stored, or shipped in accordance with 49
CFR 73.

### C. Storage of Items  {#c.-storage-of-items .TextBold .unnumbered}

Limited-access areas should be designated, when required, for storage of
packaging quality-related items.

Storage areas should be protected, should provide for access control,
and should maintain environmental storage conditions, as necessary
(e.g.*,* temperature, humidity, light).

### 3.10 Control of Engineered Items  {#control-of-engineered-items .TextBold .unnumbered}

### Control of engineered items that have been specifically designed to DOE/NNSA Defense Programs requirements and those that require traceability should be assigned a unique identifier through the use of identification numbers, color coding, or similar means. 10 CFR 71 Subpart H requires that the quality category of each packaging component be identified using a graded approach. These category designations are identified in the SARP and approved by DOE/NNSA Service Center when DOE/NNSA issues the OTC. Subsequent design changes to selected category items must be submitted to DOE/NNSA PCD for review and approval before the design changes are issued for use. {#control-of-engineered-items-that-have-been-specifically-designed-to-doennsa-defense-programs-requirements-and-those-that-require-traceability-should-be-assigned-a-unique-identifier-through-the-use-of-identification-numbers-color-coding-or-similar-means.-10-cfr-71-subpart-h-requires-that-the-quality-category-of-each-packaging-component-be-identified-using-a-graded-approach.-these-category-designations-are-identified-in-the-sarp-and-approved-by-doennsa-service-center-when-doennsa-issues-the-otc.-subsequent-design-changes-to-selected-category-items-must-be-submitted-to-doennsa-pcd-for-review-and-approval-before-the-design-changes-are-issued-for-use. .TextBold .unnumbered}

###  {#section-7 .TextBold .unnumbered}

**3.11** []{#Control_of_Commercially_Procured_Items .anchor}**Control of
Commercially Procured Items**

Commercially available items should have identification requirements
established by the DOE/NNSA Service Center. These requirements should be
included in procurement documents when traceability is to be maintained
by the user. Traceability is maintained through batch numbers, heat
numbers, lot numbers, purchase order numbers, or similar means that are
affixed to the item and that appear in supporting documentation.
Identification should be maintained on installed items and in documents
traceable to these items.

### 3.12 As Low As Reasonably Achievable (ALARA) {#as-low-as-reasonably-achievable-alara .TextBold .unnumbered}

DOE/NNSA and contractor management should ensure that procedures and
practices are developed and used to ensure that personnel exposure to
radiation is maintained *as low as reasonably achievable* as required in
10 CFR 835.

3.13 []{#Packaging_Design_Control .anchor}Packaging Design Control

A. Introduction

Packaging design related activities should have measures established and
documented to assure that the applicable specified design requirements,
such as design bases, regulatory requirements, codes, and standards are
correctly translated into the specifications, drawings, procedures, or
instructions. These measures must include provisions to assure that
appropriate quality standards are specified and included in the design
documents.

Items and processes should be designed using sound
engineering/scientific principles. Design inputs refer to the criteria,
parameters, or other design requirements upon which the final detailed
design is based. Design measures should include provisions to assure
that appropriate quality standards are specified and included in design
documents. Changes or deviations from specified design requirements or
quality standards should be identified, documented, and controlled.
Records of implementation of these measures for design control should be
available for review.

B. Package/Packaging Design Input

### 1. Input Criteria and Records: {#input-criteria-and-records .TextBold .unnumbered}

a.  Design inputs such as design bases, performance and regulatory
    requirements, codes and standards, and safety criteria should be
    identified and recorded.

b.  Changes from approved design inputs, including reasons for the
    changes, should be identified and approved by the organization that
    approved the original design input. These changes should also be
    documented, controlled, and retrievable.

2\. Analyses:

###  {#section-8 .TextBold .unnumbered}

Design input should provide for package design analyses such as
criticality physics, radiation shielding, stress, thermal, hydraulic,
accident, compatibility of materials, accessibility for in-service
inspection, maintenance and repair, hazard assessment, features to
facilitate decontamination and delineation of acceptance criteria for
inspections, and tests.

### 3. Suitability Selection and Review {#suitability-selection-and-review .TextBold .unnumbered}

a.  Measures should be established for the selection and review for
    suitability of materials, parts, equipment, and processes that are
    essential to the safety-related functions of the packaging/shipment.

b.  Design input selection should be reviewed and approved by the
    organization that requested the design and should be reviewed and
    approved by the design organization during design verification.

c.  Structures, systems or components (SSC) important to the safe and
    reliable operation of the packaging/shipment should be identified.
    For those SSC, procedures should be established to ensure that
    required maintenance/modifications are performed and documented.

C. Package/Packaging Design Process

### 1. Design Interfaces {#design-interfaces .TextBold .unnumbered}

Measures should be applied, as necessary, to identify and control design
interfaces and to coordinate participating DOE/NNSA packaging design
organizations. These measures should include the establishment of
written procedures and/or instructions for the review. Approval,
release, distribution, and revision of documents involving design
interfaces should also be controlled.

D. Package/Packaging Design Output

### 1. Design Output Requirements {#design-output-requirements .TextBold .unnumbered}

a.  The results of packaging design processes should be verified or
    checked for adequacy of design according to pre-established design
    control measures.

b.  Design output documents should relate to the design input in
    sufficient detail to permit design verification.

c.  Design outputs such as drawings, specifications, results of
    scientific investigations, computer programs, etc. should be
    established in formal written documents that have a unique
    identification and revision status, and are approved prior to issue.

d.  Design output documents should indicate that the required reviews
    and approvals have been accomplished prior to release for use in
    other design activities.

E. Package/Packaging Design Verification

### 1. Adequacy of Design {#adequacy-of-design .TextBold .unnumbered}

a.  Design verification of the packaging design should be performed by
    technically competent, independent reviewer(s) other than the
    individual(s) performing the original design or developing design
    inputs. The reviewer(s) may be from the same organization and may
    have provided technical assistance for a portion of the design.

b.  The reviewer(s) performing the verification should be competent,
    through education and/or work experience, to perform the design
    being verified.

c.  Verification may be performed by the originator's supervisor.
    However, cursory supervisory reviews are not design verification.

d.  Where state-of-the-art technology is involved, a peer review should
    be used.

e.  The concerns which design and technical reviews should address,
    include but are not limited to, the following:

    1.  Were the design inputs correctly selected?

    2.  Are the assumptions necessary to perform the design adequately
        identified and described, and are they reasonable?

    3.  Was an appropriate design method used?

    4.  Were the design inputs correctly used in the design?

    5.  Are the necessary design input and verification requirements
        specified in the design document or in supporting procedures and
        instructions?

    6.  Were the alternate calculations and analyses that were used to
        verify the correctness of the original calculations or analyses
        (performed by an independent individual or organization) of
        sufficient rigor to determine the adequacy of assumptions, input
        data, and the computer program calculation method, or other
        calculation methods?

### 2. Design Control Measures  {#design-control-measures .TextBold .unnumbered}

a.  Design reviews, alternate or simplified calculation methods, or a
    suitable testing program are examples of measures that should be
    used to verify or check the adequacy of the packaging design.

b.  A packaging design should be verified and validated before approval
    for implementation of the design, and before use as a design input
    for other design activities. When such timing cannot be met, the
    portions of the design activities that have not been verified should
    be identified and controlled.

### 3. Performance Standards {#performance-standards .TextBold .unnumbered}

a.  The verifying or checking process should be performed by individuals
    or groups other than those who performed the original design; they
    may be from the same organization, however.

b.  A graded approach to design reviews should be developed and applied
    as appropriate to consider the importance and complexity of the
    design being reviewed, the degree of standardization, the state of
    the art, hazards identified, and the similarity with previously
    proven designs.

c.  When a standardized or previously proven packaging design could be
    used, every application should be verified for conformance with
    pertinent design requirements such as 10 CFR 71.

d.  When the adequacy of packaging design will be verified by testing,
    the test requirements must be identified. These tests should
    demonstrate adequacy of performance under the most adverse
    conditions (10 CFR 71.73). Operating modes and environmental
    conditions in which the packaging/shipment must perform
    satisfactorily should be considered in determining the most adverse
    conditions. (See SG600)

e.  If testing indicates that changes to the packaging/shipment are
    necessary to obtain acceptable performance, then the item should be
    modified and retested or analyzed to assure satisfactory
    performance.

###  {#section-9 .TextBold .unnumbered}

### 4. Minimum Requirements {#minimum-requirements .TextBold .unnumbered}

Verifying or checking should consist of, at a minimum, reviewing the
packaging design, spot checking the calculations or analyses, and
assessing the results against the original design bases and functional
requirements. The particular design verification methods used should be
identified and documented.

F. Package/Packaging Design Changes

Packaging design changes, including field (operational) changes, should
be governed by measures for control of design commensurate with those
applied to the original design, including review and approval by the
organization that performed the original design, or another designated
organization which is competent in the design area of interest, and has
access to pertinent background information.

Note: If any Quality Category A design feature, requirement, or
specification on certified packaging, or any additional feature
specified by the certifying agency is changed, it must be approved by
the agency granting the Certificate of Compliance or OTC/OTA.

3.14 []{#Procurement .anchor}Procurement

Measures should be established and documented to assure that purchased
components, equipment, and services, whether purchased directly or
through contractors, conform to the DOE/NNSA approved drawings and
specifications detailed in the procurement documents, and that specific
quality requirements are identified for the items being procured and are
specified in the procurement documents. These measures should include
provisions, as appropriate, for source evaluation and selection,
objective evidence of quality furnished by the contractor, inspection
and audit at the source, and examination of items upon delivery. (See
DOE/AL QC-1, Section III, 4.2, Supplier Assessment.)

DOE/NNSA organizations have responsibility for following the procurement
process to ensure that procured items and services comply with
documented requirements and perform acceptably. Suppliers are evaluated
and selected to meet these criteria under management controls compliant
with the DOE regulations. Quality assurance personnel perform vendor
surveillances as directed by the project management plans, the design
authority, and specifications, or other engineering requirements. The
DOE quality personnel should maintain records of any DOE/NNSA lead
evaluations and performance for reference in future procurements. The
identification and resolution of Suspect/Counterfeit items continues to
be a part of procurement quality, and purchasing activities and
function.

3.15 []{#Inspection_and_Acceptance_Testing .anchor}Inspection and
Acceptance Testing

Inspection and acceptance testing of specified items (i.e., packagings,
transport vehicles, aircraft, and prime movers) and processes should be
conducted using established written acceptance and performance criteria.

### 3.16 Computer Software Control  {#computer-software-control .TextBold .unnumbered}

DOE/NNSA package certification applicants and support contractors must
establish, maintain and use computer software controls that are based on
the American Society of Quality Control (ASQC) standards.

###  {#section-10 .TextBold .unnumbered}

###  {#section-11 .TextBold .unnumbered}

###  {#section-12 .TextBold .unnumbered}

###  {#section-13 .TextBold .unnumbered}

###  {#section-14 .TextBold .unnumbered}

###  {#section-15 .TextBold .unnumbered}

###  {#section-16 .TextBold .unnumbered}

###  {#section-17 .TextBold .unnumbered}

###  {#section-18 .TextBold .unnumbered}

### APPENDIX A {#appendix-a .TextBold .unnumbered}

###  {#section-19 .TextBold .unnumbered}

### Guide {#guide .TextBold .unnumbered}

### for  {#for .TextBold .unnumbered}

### Reviewing SARPs and TSRAs {#reviewing-sarps-and-tsras .TextBold .unnumbered}

### and {#and .TextBold .unnumbered}

### Performing Confirmatory Analysis {#performing-confirmatory-analysis .TextBold .unnumbered}

###  {#section-20 .TextBold .unnumbered}

###  {#section-21 .TextBold .unnumbered}

###  {#section-22 .TextBold .unnumbered}

###  {#section-23 .TextBold .unnumbered}

###  {#section-24 .TextBold .unnumbered}

###  {#section-25 .TextBold .unnumbered}

###  {#section-26 .TextBold .unnumbered}

###  {#section-27 .TextBold .unnumbered}

**1.0** []{#Appendix_A_Introduction .anchor}**Introduction**

The information on SARP/TSRA/HAR reviews and SARP/TSRA confirmatory
reviews provided in this Appendix is intended as guidance for the PCD
CEs and PCD customers.

**2.0** []{#Appendix_A_Reviewing_SARPs_TSRAs .anchor}**Guidance for
Reviewing SARPs and TSRAs**

###  {#section-28 .unnumbered}

The PCD uses NRC NUREG-1609, *Standard Review Plan for Transportation
Packages for Radioactive Materials* as a guide for performing these
reviews.

### SARP and TSRA Review Process and Timelines

###  {#section-29 .unnumbered}

### Review Process and Timelines for Initial Certification of a Type B Package and for Certifying a NNSA Currently Certified Type B Package with New Content(s), and for the Initial Issuance of an OTA Based on a TSRA 

The process and timelines for a typical SARPs review for an initial
certification of a Type B Package and for certifying a NNSA Currently
Certified Type B package with new content, and issuance of the
associated OTC, and for reviewing a TSRA and issuing an initial OTA are
summarized below. Unless funding or other resources dictate otherwise,
the review timeline begins when the TSRP receives the SARP/TSRA from the
SARP/TSRA Owner on the prearranged schedule. The processes described in
Sections A, C, D, E, F, G and H below must be performed in sequence. The
processes described in Section B must begin not later than two weeks
after the SARP/TSRA review begins (Section A processes begin).

**A.** Perform SARP/TSRA Review: 12 weeks

1.  TSRP reviews SARP/TSRA and prepares and submits comments to the TSRP
    chairman: 10 weeks

2.  TSRP Chairman consolidates comments and distributes to TSRP members
    and the SARP/TSRA Owner prior to TSRP meeting, when possible: 4 days

3.  TSRP meeting: 2 days

4.  Finalize and issue Q~0~ comments: 4 days

**B.** Perform Confirmatory Analysis: 18 weeks

1.  Develop and issue confirmatory comments: 16 weeks

2.  Develop and issue confirmatory report: 2 weeks

**C.** SARP/TSRA Owner prepares and submits Q~0~ responses: 7 weeks

**D.** TSRP reviews Q~0~ responses, and prepares and submits Q~1~
comments which include confirmatory comments: 4 weeks

**E.** SARP/TSRA Owner reviews Q~1~ comments and prepares and submits
responses: 6 weeks

**F.** TSRP closes out comments and approves SARP/TSRA: 5 weeks

**G.** SARP/TSRA Owner completes and distributes approved SARP/TSRA: 2
weeks

**H.** Service Center completes, approves and distributes OTC/OTA, SER
and transmittal letter: 4 weeks

Additional time may be required when more than two rounds (Q~0~ and
Q~1~) of TSRP comments and SARP/TSRA Owner response cycles are needed to
resolve all comments, and/or if significant comments are generated from
the TSRP\'s confirmatory analyses, and/or delays inherent in
transmitting classified documents among the process participants are
experienced.

1.  []{#Timelines_for_recert_reauthorization .anchor}**Review Process
    and Timelines for Recertification of a NNSA Currently Certified Type
    B Package or Revision of an OTA Based on a Revised TSRA**

The process and timelines for a typical SARP and associated documents
review for the recertification of a NNSA Currently Certified Type B
package and revision of OTAs based on a revised TSRA are summarized
below. Unless funding or other resources dictate otherwise, the review
timeline begins when the TSRP receives the TSAR or SARP and associated
documents from the SARP/TSRA Owner on the prearranged schedule. The
processes described in Sections A, C, D, E, F, G and H below must be
performed in sequence. The processes described in Section B must begin
not later than one week after the SARP/TSRA review begins (Section A
processes begin).

**A.** Perform SARP Review: 8 weeks

1.  TSRP reviews TSRA or SARP and associated documents, and prepares and
    submits comments to the TSRP chairman: 6 weeks

2.  TSRP Chairman consolidates comments and distributes to TSRP members
    and the SARP/TSRA Owner prior to TSRP meeting, when possible: 4 days

3.  TSRP meeting: 2 days

4.  Finalize and issue Q~0~ comments: 4 days

**B.** Perform Confirmatory Analysis: 12 weeks

1.  Develop and issue confirmatory comments: 10 weeks

2.  Develop and issue confirmatory report: 2 weeks

**C.** SARP/TSRA Owner prepares and submits Q~0~ responses: 5 weeks

D.  TSRP reviews Q~0~ responses, and prepares and submits Q~1~ comments
    which include confirmatory comments: 3 weeks

E.  SARP/TSRA Owner reviews Q~1~ comments and prepares and submits
    responses: 4 weeks

F.  TSRP closes out comments and approves TSRA or SARP and associated
    documents: 2 weeks

G.  SARP/TSRA Owner completes and distributes approved TSRA or SARP and
    associated documents: 2 weeks

H.  Service Center completes, approves and distributes OTC/OTA, SER and
    transmittal letter: 2 weeks

Additional time may be required when more than two rounds (Q~0~ and
Q~1~) of TSRP comments and SARP/TSRA Owner response cycles are needed to
resolve all comments, and/or if significant comments are generated from
the TSRP\'s confirmatory analyses, and/or delays inherent in
transmitting classified documents among the process participants are
experienced.

**4.0** []{#Appendix_A_HAR_Timelines .anchor}**HAR Submission Schedule
and Review Timelines**

The 60-day window starts the day the HAR is received by PCD.

The process/timelines for reviewing HARs and developing a new or revised
OTA and SER are summarized as follows:

**A.** CE receives HAR, performs HAR review provides initial Qs to
applicant - 3 weeks

**B.** Applicant develops responses to Qs and submits to CE and through
an iterative process the CE approves the applicant's responses - 3 weeks

**C.** CE develops SER and OTA, OTA is approved and distributed -- 2
weeks

### 5.0 Guidance for Performing SARP Confirmatory Analysis {#guidance-for-performing-sarp-confirmatory-analysis .unnumbered}

The confirmatory analysis begins as soon as the SARP is received by the
organization tasked to perform the analysis, and typically takes
approximately 16 weeks. The following sections describe the objectives
of the confirmatory analysis and a brief description of what the
reviewer does to perform the analysis.

**A.** Structural Confirmatory Analysis

The primary objective of the structural confirmatory analysis is to
provide a detailed confirmation of the validity of the applicant's
calculational methods and resulting conclusions used for demonstrating
acceptable regulatory compliance. Also, due to the importance of ASME
Boiler and Pressure Vessel Code (BPVC) requirements in demonstrating
acceptable structural performance, the applicant's ASME BPVC
calculations and interpretations are verified by independent
calculations. The verification of the applicant's calculational methods
is accomplished by various alternate methods selected by the reviewer
based on the complexity of the applicant's analysis.

In most free drop, crush, and puncture evaluations, the applicants will
use complex finite element analysis (FEA) computer simulations and/or
testing to demonstrate acceptable structural performance of the package.
In other cases, the applicant will use simplified quasi-static
evaluations and empirical methods. The reviewer selects an appropriate
alternate method to verify that the applicant's evaluations and results
are technically valid, the computer program is appropriate for the
application, the assumptions are valid, appropriate material properties
are used, applicable code requirements are met, and the evaluation is
consistent with physical laws.

When an applicant uses complex FEA elastic-plastic computer simulations
to predict acceptable performance and structural behavior, detailed
verification of the accuracy of programming codes and numerical modeling
assumptions are not economically feasible due to the complexity of the
codes and enormous amount of data generated by the computer simulation.
Subsequently, the reviewer uses conservative, independently developed
FEA computer simulations to assess the technical validity of the results
stated by the applicant. When possible, the computer simulations used by
the reviewer are developed using different and appropriately comparable
computer codes. The reviewer uses these computer simulations to verify
that the applicant's results, predictions, and conclusions about the
structural behavior of the package are valid.

When the applicant uses testing to verify packaging compliance, the
tests should be performed using the initial conditions specified in
Regulatory Guide 7.8. The reviewer then uses confirmatory computer
simulations to verify the validity of the applicant's predictions of
acceptable package performance for environmental conditions specified in
the regulations. In all cases, the objective of the confirmatory
analysis is to verify that package performance is accurately
demonstrated and meets regulatory requirements for maintaining
containment, subcriticality, and shielding.

**B.** Thermal Confirmatory Analysis

The primary objective of the thermal confirmatory analysis is to provide
a detailed confirmation of the validity of applicant's calculational
methods and resulting conclusions used for demonstrating acceptable
regulatory compliance. The verification of the applicant's calculational
methods is accomplished by various alternate methods selected by the
reviewer based on the complexity of the applicant's analysis.

In most cases for normal and fire accident conditions, the applicants
will use complex computer simulations and/or testing to demonstrate
acceptable performance of the package. In other cases, the applicant
will use empirical methods. The reviewer selects an appropriate
alternate method to verify that the applicant's evaluations and results
are technically valid, the computer program is appropriate for the
application, the assumptions are valid, appropriate material properties
are used, applicable code requirements are met, and the evaluation is
consistent with physical laws.

When an applicant uses computer simulations to predict acceptable
performance and thermal behavior, detailed verifications of the accuracy
of programming codes and numerical modeling assumptions are not
economically feasible due to the complexity of the codes and enormous
amount of data generated by the computer simulation. Subsequently, the
reviewer uses conservative and independently developed computer
simulations to assess the technical validity of the results stated by
the applicant.

When possible, the computer simulations used by the reviewer are
developed using different and appropriately comparable computer codes.
The reviewer uses these computer simulations to verify that the
applicant's results, predictions, and conclusions about the thermal
performance of the package are valid.

When the applicant uses testing to verify packaging compliance, the
tests are normally performed under nominal ambient conditions. The
reviewer then uses confirmatory computer simulations to verify the
validity of applicant's predictions of acceptable package performance
for environmental conditions specified in the regulations. In all cases,
the objective of the confirmatory analysis is to verify that package
performance is accurately demonstrated and meets regulatory requirements
for maintaining containment, subcriticality, and shielding.

**C.** Containment Confirmatory Analysis

The containment chapter is reviewed to determine the bounding source
term and what was analyzed to demonstrate compliance with 10 CFR 71
normal conditions of transport (NCT) and hypothetical accident
conditions (HAC) leakage rate limits.

Confirm that the source term selected as bounding for the containment
evaluation is consistent with the allowable payloads in Chapter 1, and
confirm overall consistency of source term with that used in the
shielding and criticality evaluations, while recognizing that these
evaluations have different considerations.

Independently calculate the bounding source term for the containment
evaluation (i.e., A~2~ for mixture, activity-to-A~2~ value ratios, etc.)
using ORIGEN-S to build in decay products for various decay times.
Verify that the correct decay time was selected as bounding for the
source terms used in the containment evaluation in the SARP.

Calculate the reference leakage rates per ANSI 14.5 using the bounding
source term(s) and compare against the SARP results to verify
correctness. Verify that the NCT and HAC pressures and temperatures used
in the leak rate calculations are consistent with the results from the
thermal evaluation in Chapter 3.

**D.** Shielding Confirmatory Analysis

The shielding chapter is reviewed to determine the bounding source term
and what package configurations were analyzed to demonstrate compliance
with 10 CFR 71 NCT and HAC dose rate limits. Confirm that the source
term selected as bounding for the shielding evaluation is consistent
with the allowable payloads in Chapter 1, and confirm overall
consistency of source term with that used in the containment and
criticality evaluations, while recognizing that these evaluations have
different considerations.

Independently calculate the gamma and neutron radiation emission rates
for the bounding source term using ORIGEN-S for various decay times.
Verify that the correct decay time was selected as bounding for the
gamma and neutron source terms used in the SARP.

Develop three-dimensional Monte Carlo Neutral Particle (MCNP) models for
NCT and HAC consistent with the models contained in the SARP. Calculate
NCT and HAC dose rates and compare against the SARP results and confirm
that they are within the allowable limits. Ensure that no anomalies
exist between the MCNP and SARP results. If anomalies exist, investigate
and document conclusions in the confirmatory report and/or provide
additional questions.

**E.** Criticality Confirmatory Analysis

The criticality chapter is reviewed to determine the bounding source
term.

Confirm that the source term selected as bounding for the criticality
evaluation is consistent with the allowable payloads in Chapter 1, and
confirm overall consistency of source term with that used in the
shielding and containment evaluations, while recognizing that these
evaluations have different considerations.

Develop three-dimensional MCNP models for NCT and HAC consistent with
the models contained in the SARP. Duplicate the criticality calculations
performed in the SARP to ensure all-important conditions were properly
considered. Include additional confirmatory cases if the SARP did not
adequately address certain parameter sensitivities. Ensure that no
anomalies exist between the MCNP and SARP results. If anomalies exist,
investigate and document conclusions in the confirmatory report and/or
provide additional questions.

### 6.0 Guidance for Performing TSRA Confirmatory Analysis {#guidance-for-performing-tsra-confirmatory-analysis .TextBold .unnumbered}

The TSRA document is reviewed to determine the postulated normal and
credible accident conditions and their relation to the NCT and HAC in 10
CFR 71. The number of confirmatory analyses to be performed will be
based on the 10 CFR 71 NCT and HAC events that are addressed in the
TSRA. The appropriate structural and thermal confirmatory analyses will
be performed for all NCT and HAC structural and thermal events that are
evaluated in the TSRA.

The objective of both the structural and thermal confirmatory analyses
is to provide a detailed confirmation of the validity of the applicant's
calculational methods and resulting conclusions used for demonstrating
compliance with 10 CFR 71. The verification of the calculational methods
is accomplished by various alternate methods that are selected by the
reviewer based on the complexity of the applicant's analysis. The
reviewer selects an appropriate method to verify that the applicant's
evaluations and results are valid, the computer program is appropriate
for the application, the assumptions are valid, appropriate material
properties are used, applicable design code requirements are met, and
the evaluation is consistent with physical laws.

In addition to the structural and thermal confirmatory analyses,
shielding, criticality, and containment confirmatory analyses are also
performed. The shielding section is reviewed to determine the bounding
source term and then the source term is independently confirmed using
the ORIGEN-S code. A three-dimensional model of the package is developed
using the MCNP code and the dose rates are calculated and compared to
the results listed in the TSRA. For fissile material, the criticality
source term is confirmed and a three-dimensional model of the package is
prepared using MCNP. The MCNP model is used to confirm the criticality
calculations in the TSRA and is also used to perform additional
sensitivity analyses to determine if the worst-case scenarios were
addressed. For the containment section, the bounding source term is
confirmed and compared to the source term used in the shielding and
criticality sections. The reference leakage rates are calculated per
ANSI N14.5 using the bounding source term and the results are used to
verify the results in the TSRA.

The TSRA will contain a probabilistic risk assessment (PRA) for those
requirements in 10 CFR 71 that cannot be met by the package. The PRA
confirmatory analysis includes an independent assessment of the
variables and basic data used to calculate accident frequencies and
consequences, critical review of the accident progression models (i.e.,
combinations of events that lead to a release of radioactive materials),
hand calculations which attempt to duplicate the results of the accident
frequency calculations, validation of release fractions used in the
analysis, application of alternative atmospheric dispersion models to
calculate concentrations of released radioactive and hazardous materials
at various receptor locations, and verification that risk‑related
conclusions are valid. If necessary, an independent PRA will be prepared
to verify the results in the TSRA.

### Appendix B {#appendix-b .TextBold .unnumbered}

###  {#section-30 .TextBold .unnumbered}

### Guide {#guide-1 .TextBold .unnumbered}

### for {#for-1 .TextBold .unnumbered}

### Developing {#developing .TextBold .unnumbered}

### SARPs, SRs, TSRAs and HARs {#sarps-srs-tsras-and-hars .TextBold .unnumbered}

###   {#section-31 .TextBold .unnumbered}

###  {#section-32 .TextBold .unnumbered}

**1.0** []{#Appendix_B_Intro .anchor}**Introduction**

The guidance provided in this Appendix, if followed and all of the
required elements are met, will facilitate the processing of OTC/OTA
application and/or SARP/TSRA/HAR approval by PCD and will improve the
probability of an applicant receiving authorization in time to support
their program.

**2.0** []{#Appendix_B_Guide_for_Developing_SARPs .anchor}**Guide for
Developing SARPs/SARP Addendums**

DOE Order 461.1A specifies that DOE/NNSA SARPs must conform to NRC
Regulatory Guide 7.9, *Standard Format and Content of Part 71
Applications for Approval of Packaging for Radioactive Material.*
However, Regulatory Guide 7.9 is extremely out of date. NRC NUREG-1609,
*Standard Review Plan for Transportation Packages for Radioactive
Material* provides guidance for performing and documenting SARP reviews,
and it is more comprehensive than Regulatory Guide 7.9. Therefore,
NUREG-1609 is the preferred guide for developing DOE/NNSA SARPs, and
applicants are encouraged to use the template provided in NUREG-1609 for
their SARPs.

The SARP should document the structural, thermal, containment,
shielding, and criticality safety features; the acqui­sition and
maintenance control programs; operating procedures; and associated
quality assurance measures for the packaging (10 CFR 71, and
NUREG-1609/Regulatory Guide 7.9). A SARP should be developed in
conformance with: this guide; Safety Guide 100; Safety Guide 200; Safety
Guide 600; NRC NUREG/CR-3019, *Recommended Welding Criteria for Use in
the Fabrication of Shipping Containers for Radioactive Materials*;
NUREG/CR-3854, *Fabrication Criteria for Shipping Containers*,
NUREG/CR-4775, *Guide for Preparing Operating Procedures for Shipping
Packages*; NUREG 7.8, Regulatory Guide 7.6, Regulatory Guide 7.11, and
NUREG-1609/Regulatory Guide 7.9, as amended, for Type A or B quantities.
The SARP would include:

**A.** A description of the proposed packaging in sufficient detail to
identify the packaging accurately and provide the basis for evaluating
the packaging.

**B.** Identification of established codes and standards proposed for
use in package design, fabrication, assembly, testing, mainte­nance, and
use. In the absence of any established codes and standards, the
DOE/NNSA/contractor should describe the basis and rationale used to
establish the packaging quality assurance program.

**C.** Demonstration of compliance with each applicable section of
10 CFR 71 and any other requirements specified by DOE/NNSA. For example,
DOE/NNSA PCD thermal testing guidance contained in Safety Guide 141.1,
*Combination Test/Analysis Method Used to Demonstrate Compliance to DOE
Type B Packaging Thermal Test Requirements*. The SARP's format and
content shall conform to the guidance provided in NUREG-1609/Regulatory
Guide 7.9. The SARP shall provide evidence that the test performed in
compliance with the requirements of 10 CFR 71 conform to the initial
conditions provided in Regulatory Guide 7.8 tests, and that the
fabrication of the containers conform to the guidance provided in
NUREG/CR-3019 and NUREG/CR-3854.

**D.** A completed SG-200 Checklist that provides evidence for
determining the completeness of the SARP in addressing the regulatory
requirements.

**E.** This submittal should be made 9 months before the first use date
for new packagings and/or 9 months before the packaging certification
expiration date. Submittal in this context means that the SARP must be
in the hands of PCD and the recipients identified in the list provided
by PCD.

**3.0** []{#Appendix_B_Developing_Supplemental_Repor .anchor}**Guide for
Developing Supplemental Reports**

The SR must be prepared in support of package recertification requests
and must be submitted by the applicant to PCD prior to or with the
revised SARP. The purpose of the SR is to document the information
concerning the package use and performance during the most recent
certification period (generally the last 5 years), the current inventory
of packagings, and a summary of the changes made to the SARP.

The SR should be organized in a manner consistent with the format
provided below and should address the issues discussed in the format:

[Current Packaging Inventory]{.underline}

This section should include the following information:

**A.** Available Packaging -- The number of packagings available for
shipping throughout the complex, including those temporarily at
Department of Defense (DoD) or en route between DOE and DoD;

**B.** Onsite Storage -- Number of packagings used for onsite storage at
sites throughout the complex, including DoD, if applicable;

**C.** Procurement -- Specify plans, if any to procure additional
packagings. In this context, container refers to drums and/or inner
containers (for drum-type containers); and,

**D.** Vendors of Packaging Components -- The manufacturer of packaging
components (e.g., drum, inner container, O-rings, insulation) should be
specified, as well as any contemplated changes in suppliers. The PCD may
perform surveys of the suppliers, or review the applicant's survey
documents/reports and all other related quality assurance records.

[Package History]{.underline}

The package history section must cover the package's activities during
the most recent certification period. That is, the last five years or
the time between the last certification and the recertification process
period if it happens to be less than five years. The package history
section must contain the following information:

**A.** Package Use -- Items which must be discussed include: the number
of shipments made; the reportable occurrences, their root causes, and
how they were resolved/corrected; packages removed from service due to
damage or radioactive contamination; and any other incidents during
their use that are relevant to the package performance. Reportable
occurrences for the same container with different contents must also be
provided.

**B.** Acceptance and Maintenance Data -- The following information
should be included:

1\. Summary of data obtained from acceptance tests on procured
materials/components;

2\. Summary of data obtained during refurbishment and/or maintenance
activities; and,

3\. Summary of reports obtained from vendor surveys and quality
assurance appraisals.

[Continued Use of Package]{.underline}

Discuss the need for continued use of the package, including the
expected time period, and any anticipated changes in use.

[Container Modifications]{.underline}

Identify and discuss all modifications made to the design of the
certified container since the current certification was issued. All
modifications require the approval of DOE/NNSA PCD (10 CFR 71.107(c)).
The rationale for the design change should be identified and the effect
that the change has on the container's ability to comply with applicable
regulations should be discussed. Tests and associated analysis performed
to demonstrate the modified container's compliance with the federal
regulations should be presented in the Testing section of the SR.

[Testing]{.underline}

Discuss the additional testing and associated analysis performed (if
any) to support recertification, and summarize the results. For packages
with a modified design, provide justification if the entire 10 CFR 71
Normal Conditions of Transport and Hypothetical Accident Conditions test
series were not performed. Provide confirmation that the initial
conditions specified in Regulatory Guide 7.8 were used.

[Compliance with Orders and Regulations]{.underline}

Discuss changes made to applicable requirements since the package was
certified, and provide test data or analysis that documents the
package's compliance with the current requirements.

**A.** Federal Regulations

> Discuss any changes made to 10 CFR 71 or 49 CFR 170-173, and the
> effect that these changes had on the package's certification basis.

**B.** DOE/NNSA Requirements

> Discuss changes made to DOE Orders and DOE/NNSA guidance documents
> such as the DOE/NNSA PCD issued safety guides. Include a discussion of
> the effects that these changes had on the package's certification
> basis.

**C.** NRC Guides

> Discuss the packages' conformance to the requirements specified in
> Regulatory Guide 7.8, NUREG/CR-3019, and NUREG/CR-3854.

**D.** Miscellaneous Requirements

> Identify changes to other requirements that affect the packaging
> program.

[SARP Changes]{.underline}

Summarize all approved changes to the SARP. Changes that are discussed
in other sections of the SR may be referenced rather than repeated.

### 4.0 Guide for Implementing SARP Document Control Measures  {#guide-for-implementing-sarp-document-control-measures .TextBold .unnumbered}

The purpose of these control measures is to promote consistency among
SARPs and to provide adequate controls to ensure that sites will
maintain up-to-date SARPs. The focus of the policy is on administrative
policies related to document production and distribution, and not on
classification or classified document control requirements. Users are
responsible for following security and classification policies effective
at their site. This policy is mandatory for all SARPs under the
jurisdiction of DOE/NNSA. This policy may also be used for other types
of documents. The Manager, Packaging Certification Division, is
responsible for revisions and changes to this policy. Changes should be
reviewed and approved by the same organizations that performed the
original review and approval, unless other organizations are
specifically designated by an individual with the authority to do so.
The reviewing organization should have access to pertinent background
information upon which to base its approval, and should have adequate
understanding of the requirements and intent of the original record. The
changes should include the date and the identification of the person
authorized to issue such changes.

**A.** Document pages may be numbered sequentially (1, 2, 3) or by SARP
Chapter (1-1, 1-2). If a change will not fit in the existing pages,
additional pages may be added, e.g., 123A or 4-3A. These extra pages
should be renumbered at the next revision.

**B.** Each page in the body of the SARP shall include a footer that, as
a minimum, identifies the SARP or document number, revision, change
number (if applicable), and the issue date of the change. Organizations
are free to add other information and choose the format of the footer.

**C.** A return receipt is issued for all revisions and changes. The
addressee's name will be given on the return receipt for all revisions
and changes. The addressee should send the return receipt back to the
place of issuance.

**D.** The organization issuing a change or revision shall verify that
receipts are returned. If receipts are not returned, the issuing
organization should make reasonable attempts to contact the site.
DOE/NNSA PCD should be notified if the problem cannot be resolved.

**E.** The initial issue of a SARP will be referred to as "Revision 0"
(R0). The SARP cover page is required to contain a title, an issue date,
a document and revision number, and the name and location of the issuing
organization. The initial SARP revision will not contain change pages.
Revisions will be issued with return receipts for all distribution
copies. If a large number of pages have been changed either by one
specific change or cumulatively by several changes, the SARP TSRP
chairman may decide that a new revision should be issued. New revisions
will incorporate all prior changes with new and proper pagination and
include a new cover page with the new date and revision number.

**F.** All information that is revised by a change will be marked in the
margin as shown in the following example:

The mass of the content is less than the mass of the package.

Also, the mass of the...

**Note:** Changes should be numbered sequentially starting with "C1."

**G.** Issuance of a Change should include return receipts, instruction
sheets, and a list of affected pages. Requirements are noted below:

The Instruction Sheet will contain the information listed below:

1.  Instructions for posting changes such as, "Please remove pages and
    replace with new change pages as described below. Destroy all
    superseded pages according to appropriate procedures."

2.  A two-column list that shows pages which are to be removed on the
    left and corresponding pages to be inserted on the right. See
    example below:

  ----------------------------------- -----------------------------------
  **Old Pages**                       **New Pages**

  iii-x                               iii-x

  1-1 thru 1-6                        1-1 thru 1-6

  1-9 thru 1-18                       1-9 thru 1-18D

  1-27 thru 1-30                      Deleted

  1-157 thru 1-188                    1-157 thru 1-188

  1-203 thru 1-204                    1-203 thru 1-204
  ----------------------------------- -----------------------------------

**H.** The List of Affected Pages is a summary of all changes that have
been posted to the revision. The column on the left indicates the page
number(s) of the changed page(s) and the column on the right indicates
the number of the change that changed that specific page. The example
shown indicates that two changes have been issued to the revision. Pages
that are not noted in the table have not been changed. This table can be
included on the back of the instruction sheet.

  ----------------------------------- -----------------------------------
  **Page**                            **Change**

  iii-x                               2

  1-1 thru 1-6                        2

  1-7 thru 1-8                        1

  1-9 thru 1-18D                      2

  1-27 thru 1-30                      2

  1-45 thru 1-48                      1

  1-157 thru 1-188                    2

  1-203 thru 1-204                    2
  ----------------------------------- -----------------------------------

**I.** When a set of change pages is received, the changes will be
posted to the document as instructed. A note to that effect, with the
date posted and name of person posting the change, should be included.

**J.** The Instruction Sheet and List of Affected pages will be in front
of the title page. All portions of the change will be retained. All
superseded pages will be destroyed in accordance with applicable
procedures.

**K.** The return receipt will be signed by the addressee and returned
to the place of issuance. A copy of the return receipt may be retained
with the document.

### 5.0 Guide for Developing TSRAs for Containers Used to Package Type B Quantity RAM {#guide-for-developing-tsras-for-containers-used-to-package-type-b-quantity-ram .TextBold .unnumbered}

The following outline identifies the minimum information that should be
included in each section of a TSRA. In general, a TSRA will address the
issues of package shielding, containment, and subcriticality for both
NCT and HAC. A TSRA should conform to the extent practicable with the
general outline of NUREG-1609/Regulatory Guide 7.9, *Standard Format and
Content of Part 71 Applications for Approval of Packaging for
Radioactive Material* (NRC 1986). It should address the Type B package
requirements of 10 CFR 71, "Packaging and Transportation of Radioactive
Material," and to the extent possible, (1) identify the specific
conditions the packaging system is unlikely to withstand without
releasing material in excess of established limits and (2) indicate
instances in which approval to ship will be based on a PRA. A summary of
composite risk to the public (consequences and frequency) from all
hazard mechanisms should be provided.

1\. General Information

a\. Introduction

This section should include a brief overview of the packaging system and
description of the cargo and shipping campaign. The introduction should
incorporate a general discussion of 10 CFR 71 NCT and HAC requirements
as applied to the package safety basis for shielding, containment, and
subcriticality. Requirements that are addressed through the conduct of a
probabilistic risk assessment should be identified. The section is to
include a summary of composite risk to the public (consequences and
frequency) from all hazard mechanisms associated with the proposed
shipping campaign. Operational controls necessary to mitigate risk to
the public should be identified if required. The criticality transport
index and shielding transport index should be included.

b\. Packaging System and Shipping Campaign Description

This section should include descriptions of the packaging system
(including the transport vehicle and separate internal packagings, where
applicable) and shipping campaign. Package information should include
gross weight, materials, dimensions, internal and external structures
including over-packs, lifting and tiedown devices, shielding, valves,
ports, and other special package features. The confinement and
containment (if applicable) boundaries should be clearly identified.
Descriptions of the transport and tie-down configurations should also be
provided. Sketches should be included to clarify the packaging system
description. Special operational features required for the mitigation of
risk should be discussed.

A general payload description should be included with sketches.
Materials in the payload should be clearly identified with information
on mass, physical and chemical form, and density. All hazardous material
including RAM should be described completely and accurately. The
description for the RAM must include the material's mass, radionuclide
activity, isotopic composition, physical and chemical form, decay heat,
and density. Maximum decay heat, maximum pressure buildup in the inner
container, and loading restrictions should be identified. Specify
conditions for maximum pressure buildup in both the expected NCT and
HAC.

A general description of the shipping campaign should be included.
Information should be given on the number of units per vehicle, total
units to be shipped, campaign time period, and routing.

c\. Regulatory Compliance

This section is to include a discussion of compliance with each section
of 10 CFR 71 Subpart D, E, F, G and H applicable to a Type B quantity of
material in each AS or package. Package response to the 10 CFR 71 NCT
and HAC should be described. This section should provide confirmation
that the tests complied with the initial conditions specified in
Regulatory Guide 7.8, and provide confirmation that the packages
are/will be fabricated in conformance with NUREG/CR-3019 and
NUREG/CR-3854**.** Package failure thresholds or equivalent should be
provided. Package responses being addressed via a probabilistic risk
assessment should be identified where the unit is non-compliant with 10
CFR 71 equivalence. Identification of established DOE, NRC, or NNSA
contractor codes and standards proposed for application to package
testing, maintenance, quality assurance, and use will be included.

d\. Summary of TSRA Sections

Synopses of each of the TSRA sections will be prepared that summarize
the results of the analysis and/or testing of the packaging system. This
will include a statement of the risk (consequences and frequency of
potential accidents) from all hazards to the public resulting from the
proposed shipment campaign.

e\. Appendix

The Appendix of Section 1 should include detailed dimensional drawings
of the packaging, packaging contents, overpack, tiedown, and loading
configurations.

2\. Structural Evaluation

Follow guidance given in NRC (1986) for structural design, weights and
centers of gravity, mechanical properties of materials, general
standards for all packages (include all subsections of 10 CFR 71.43),
and lifting and tiedown standards (10 CFR 71.45).

For NCT assess packaging system performance through test or analysis to
conditions specified in 10 CFR 71.71, "Normal conditions of transport."
The packaging system, including payload, payload container, overpack (if
applicable), tie-down system, and external packaging, if applicable
(e.g., TSS), should be assessed against each condition separately and a
determination made that the applicable performance requirements
specified in the regulations have or have not been satisfied. If they
have not been satisfied, provide a safety basis and justification for
package use. For NCT, the assessment should consider package only
(contents plus container/overpack), it should not take credit for
tie-down system or SST/SGT. Same comment applies for thermal evaluation.

For hypothetical accident conditions, assess packaging system
performance through test or analysis to conditions specified in 10 CFR
71.73, "Hypothetical accident conditions." The packaging system should
be assessed against each condition in the sequence specified by the
regulations. A determination should be made that the applicable
performance requirements specified in the regulations have or have not
been satisfied. If they have not been satisfied, provide packaging
system failure thresholds or equivalent for use in the PRA. Please note
that there is a need to clearly define the packaging system. This will
simplify the analysis, as it is preferable to evaluate the package alone
if possible.

The tests should conform to the initial conditions specified in
Regulatory Guide 7.8.

3\. Thermal Evaluation

Follow the guidance given in NRC (1986) for thermal evaluation. For NCT
and HAC assess packaging system performance through test or analysis to
conditions specified in 10 CFR 71.71 and 71.73, respectively. Evaluate
the packaging system performance with respect to the results of the
thermal analysis or tests. Compare the results with allowable limits of
temperature, pressure, etc., of the package components and determine if
the applicable performance requirements specified in the regulations
have or have not been satisfied. If NCT allowable limits have not been
satisfied, provide a safety basis and justification for package use. If
HAC requirements have not been met, provide packaging system failure
thresholds or equivalent for use in the PRA. Knowledge of the packaging
system failure threshold may be compared to a fully compliant package,
which helps to establish a safety basis. This helps the reviewer to
identify the margin of safety and further establishes a justification
for use of the package.

4\. Containment

Identify the containment boundary (if applicable), penetrations, seals,
welds, and closure devices. Determine compliance with 10 CFR 71.51,
"Additional requirements for Type B packages," for NCT and HAC using
ANSI standard 14.5-1997 and the performance of the packaging system
following application of normal and accident conditions as determined in
the structural, thermal, and PRA sections. If the package is not
compliant with 10 CFR 71.51, provide a safety basis and justification
for package use. In the case of NCT, the safety basis may be provided
from historical data and/or test data (e.g., stockpile sampling). For
HAC, noncompliance with containment requirements may be addressed in the
PRA. If there is not a leak-testable containment boundary then
additional emphasis should be placed on the content and any potential
dispersal.

5\. Shielding Evaluation

Following the outline provided in NRC (1986), give an analysis to
demonstrate compliance with 49 CFR 173, "Shippers---General Requirements
for Shipments and Packagings;" 173.441, "Radiation level limitations;"
and 10 CFR 71.47, "External radiation standards for all packages."
Include determination of a transport index.

6\. Criticality Evaluation

This section is to follow the general outline of NRC (1986) updated by
incorporating 10 CFR 71.55, "General requirements for fissile material
packages," and 71.59, "Standards for arrays of fissile material
packages." Credible HAC for use in modeling should be adopted from the
results of the structural, thermal, and PRA sections. All fissile
material package requirements should be discussed. If the packaging
system does not meet the requirements for NCT or HAC, a safety basis and
justification for use must be provided. If HAC requirements cannot be
met, the PRA section must predict the likelihood that the component
might be subjected to the conditions required to achieve a potential
criticality event during the entire duration of the transportation
campaign and justification for packaging system use. If possible, a
criticality transport index must be calculated.

7\. Operating Procedures

Provide a list of operating procedures per NRC (1986). Any special
procedures that result from the PRA should be included. Note that any
special requirements should be highlighted.

8\. Acceptance Tests and Maintenance Program

This section should include descriptions of acceptance tests (if
applicable) and maintenance program elements to be used on the package
in conformance with NRC (1986).

9\. Quality Assurance

This section should document the shipper's quality assurance program and
its implementation for all manufacturing phases of the package. It
should also address the implementation of the quality assurance program
in the preparation of the payload for packaging, determination of the
radioactive material contents, loading, unloading, tiedown, maintenance,
and transportation.

10\. Probabilistic Risk Assessment

This chapter provides an assessment of public risk attributable to the
proposed shipping campaign. An assessment of the frequencies of
accidents and the consequences of those accidents to members of the
public is required. The Probabilistic Risk Assessment chapter should
include details on the shipping campaign, the number of units in a
shipment, number of potential shipments, routes (or generic routes if
specific information is not available), and any other campaign
information that would have potential impact on public safety or the
environment.

The PRA should determine consequences and frequencies of accidents using
input from structural, thermal, containment, and criticality analyses of
the packaging system as appropriate. The significant potential hazards
(flammable gas, explosives, toxic, hazardous when wet, and etc.) in the
package payload should be considered in the PRA with the dominant
contributors to accident frequency and consequences identified. Other
potential accidents that the 10 CFR 71 addresses may be considered given
any unique transportation environments.

A composite summary of the risk to the public presented by the shipping
campaign should be provided. The PRA should estimate the frequency and
consequences of potential accidents. The PRA should include
sensitivity/uncertainty information to support decision-making and
development of administrative controls and operating procedures, where
appropriate. Risk may be subdivided by accident type (for instance,
criticality versus particulate dispersion) or hazard type (radiological
versus toxicological). Transportation authorization will be based on the
estimation of composite public risk and will be decided on a
case-by-case basis. The overall risk consequence should be express in
person-rem (LCF) for a population or for the maximum exposed individual
or radiation dose (mrem/h) at some distance from the source (See BWXT-12
document, Y/LF-504, Rev.1, *Effect of a Postulated Uranium
Transportation Accident*, September 1999). The likely shipping
configurations will have a direct impact on the assessment and the TSS
may be included in the assessment for the HAC.

**6.0** []{#Appendix_B_TSRAs_for_NELAs .anchor}**Guide for Developing
TSRAs for Special Assemblies Containing Type B Quantity of SNM**

The following paragraphs identify the minimum information that should be
contained in each section of the subject TSRA:

1.  **[Executive Summary.]{.mark}**

2.  **[Revision Log.]{.mark}**

3.  Lists of figures and tables, definition of terms, and list and
    definition of the acronyms used in the report.

4.  **[Introduction]{.mark}** section must, at a minimum, includes the
    following:

    a.  **[Introduction]{.mark}** subsection that provides a short
        description of the purpose of the TSRA.

    b.  **[Content Description]{.mark}** section that provides a short
        description and associated figures/graphic depiction of the
        Nuclear Explosive-Like Assembly (NELA) and its subcomponents.

    c.  **[Transportation Configuration Description]{.mark}** section
        that describes each of the NELA configurations proposed for
        shipment and provides detailed hazardous material information
        (identity of material, quantity and location) for each of the
        proposed configurations, identification of transportation
        conveyance, origin and destination of each off-site
        transportation operation (include the specific routes that will
        be used during each transportation segment), start and end dates
        of campaign, number of shipments per year, tests and
        reconfigurations that will be performed at the units
        intermediate destinations, and packaging and/or handling
        equipment (H-gear) that will be used for each of the
        transportation segments.

    d.  **[Summary of Subsequent Sections]{.mark}** that includes
        summaries of the Transportation Environment, Criticality,
        Shielding, Containment, Probability Risk Assessment, and Quality
        Assurance sections.

5.  **[Transportation Environment]{.mark}** section must, at a minimum,
    describe the transportation environments that are considered during
    each of the NELAs off-site transportation segments, include a
    section on how the NELA meets the 10 CFR 71.71 Normal Conditions of
    Transport, a section on Credible Hypothetical Accident Conditions, a
    section on the Analysis of the Transportation Conveyance, and a
    section on any other relevant information.

6.  **[Criticality]{.mark}** section must, at a minimum, provide a
    Discussions and Results of the criticality evaluation section;
    Package Fuel Loading section; Model Specifications section that
    includes subsections on description of calculation models,
    calculation model used to analyze the transportation safety critical
    NELA subassembly(s), single-unit packaging calculational model,
    array packaging calculational model, package regional densities,
    material compositions used in the transportation safety critical
    subassembly(s) calculational model, material composition used in the
    single-unit packaging calculational model, and material composition
    used in the array packaging calculational model; Criticality
    Calculation section that includes subsections on Calculational or
    Experimental Method, Fuel Loading or Other Contents Loading
    Optimization, Criticality Results, single --unit packaging
    calculational results, infinite array packaging calculational
    results, and conclusions; Criticality Benchmark Experiments section
    that includes subsections on Benchmark Experiments and
    Applicability, Details of Benchmark Calculations, and Results of
    Benchmark Calculations.

7.  **[Shielding]{.mark}** section must, at a minimum, describe the
    shielding evaluation performed on the NELA. The objective of the
    evaluation is to demonstrate the NELA's compliance with the NCT and
    HAC performance requirements specified in 10 CFR 71 and 49 CFR 173.

8.  **[Containment]{.mark}** section must, at a minimum, describe the
    containment evaluation performed on the NELA. The objective of the
    evaluation is to demonstrate the NELA's compliance with the
    requirements of 10 CFR 71 and ANSI N14.5-1997.

9.  **[Probabilistic Risk Assessment]{.mark}** section must, at a
    minimum, include a bounding analysis that demonstrates that the
    consequences resulting from a bounding credible noncriticality
    transportation accident scenario are acceptably low. At a minimum,
    the following five conservative bounding accidents must be evaluated
    and documented: (1) direct radiation exposure; (2) exposure of
    hazardous materials released by a fire; (3) effects associated with
    the release of potential energy by a fire; (4) release of hazardous
    materials into a waterway and uptake into drinking water supply;
    and (5) hazards associated with explosives, if applicable.

10. **[Quality Assurance]{.mark}** section must, at a minimum, provide a
    description of the NELA's Preparation and Test Procedures. The
    Preparation and Test Procedures shall include information on the
    NELA assembly process, each of the tests performed with the NELA,
    the post-test recovery procedures of each test and the associated
    reconfiguration process between the tests, and the planned
    disposition of the NELA after the completion of the final test.

**7.0** []{#Appendix_B_Guide_for_Developing_HAR .anchor}**Guide for
Developing HARs**

HARs and their associated transmittal memoranda are used to request
authorizations for off site shipments of special assemblies that contain
either a Type A quantity of RAM or no RAM ( e.g., Type A quantity RAM
and other hazardous materials or no other hazardous material, or no RAM
but other hazardous materials, or no hazardous materials but must be
shipped via the TSS). The HAR must contain the following:

1.  Identity of current OTA that applicant believes the "new" unit
    should be covered by, if applicable.

2.  The high-level part number and high-level graphic number for the
    proposed configuration.

3.  Copy of drawing(s) that define the proposed configuration.

4.  The identity of the container or handling gear in which the unit
    will be shipped. If the tie-down procedures for the proposed
    configuration are not contained in TP45-51D or the DOE tie-down
    manuals, the applicant must submit the proposed tie-down procedures,
    the analysis performed to verify the adequacy of the proposed
    tie-down procedures and the associated documentation for the
    proposed procedures to the OST and a copy included in the data
    package submitted to DOE/NNSA PCD.

5.  Indicate whether the shipments will be only pre-test or both
    pre-test and post-test.

6.  The identity of the unit's point of origin, destination and
    intermediate locations, if applicable.

7.  A list of all components that contain hazardous material, and the
    identity of the hazardous materials and the associated quantity of
    each hazardous material contained in each of the components.

8.  The component's MC number and Part Number (P/N). If no MC number is
    associated with the component, the applicant must provide the
    component's name and the P/N.

9.  The applicable DOT and TP 20-11 designators for components that
    contain explosives.

10. For post-test units, indicate the planned status of each component
    that contains hazardous material. Indicate whether a component that
    contains hazardous material will be fired, unfired, or unchanged as
    a result of the planned test. Provide a copy of the approved pretest
    and post-test procedures that will be used to ensure that the
    special assembly is safe to package and ship for review.

11. An analysis of the potential hazards and associated consequences
    posed by the hazardous material in the proposed shipping
    configuration(s).

The HAR shall be submitted to arrive at DOE/NNSA PCD no later than 60
days prior to the OTA need date.

> []{#Appendix_C .anchor}**APPENDIX C**

###  {#section-33 .TextBold .unnumbered}

###  {#section-34 .TextBold .unnumbered}

### Guide {#guide-2 .TextBold .unnumbered}

### for {#for-2 .TextBold .unnumbered}

### Developing {#developing-1 .TextBold .unnumbered}

### SERs, OTAs and OTCs {#sers-otas-and-otcs .TextBold .unnumbered}

### and  {#and-1 .TextBold .unnumbered}

### Description of TSRP Process  {#description-of-tsrp-process .TextBold .unnumbered}

**1.0** []{#Appendix_C_Introduction .anchor}**Introduction**

The guidance provided in this Appendix is intended to assist the PCD CEs
and to communicate to the customers documentation that must be developed
and maintained in support of Type B package certifications and offsite
transportation authorizations. The SER serves the following functions:

**A.** Provides a description of the package design, if applicable.

**B.** Documents the results of the SARP and/or TSRA review and
confirmatory analysis, or the results of the analysis of the HAR.

**C.** Confirms that the methodology, assumptions, and technical data
used are in compliance with safety standards and regulations.

**D.** Identifies packaging design deficiencies or SARP/TSRA and how
they were resolved.

**E.** Documents restrictions on the use of the packaging/shipment that
will be repeated in the OTC/OTA.

**F.** Provides the basis for recommending approval or disapproval of
the OTA/OTC.

A SER is not required for a NRC/DOT approved package, and may not be
required for a "package" that contains no hazardous material, or the
hazardous material contained in the "package" presents very little risk
and the hazardous materials are fully documented in the OTA.

## 2.0 Guide for Developing SERs for Type B Packages {#guide-for-developing-sers-for-type-b-packages .unnumbered}

NUREG-1609, *Standard Review Plan for Transportation Packages for
Radioactive Material* contains guidance for reviewing SARPs and a format
and content for documenting those reviews. Copies of NUREG-1609 can be
obtained from the Nuclear Regulatory Commission Web Site located at
[www.nrc.gov](http://www.nrc.gov/) or by going directly to
[www.nrc.gov/reading-rm/doc-collections/nuregs/staff/sr1609/](http://www.nrc.gov/reading-rm/doc-collections/nuregs/staff/sr1609/).

The SER should describe how the package and SARP conform to the
specifications provided in Regulatory Guide 7.8, NUREG/CR-3019 and
NUREG/CR-3854.

##  {#section-35 .unnumbered}

## 3.0 Guide for Developing SERs for Type A Packages and Special {#guide-for-developing-sers-for-type-a-packages-and-special .unnumbered}

##  Assemblies that contain No SNM or Less than Type B Quantity of SNM {#assemblies-that-contain-no-snm-or-less-than-type-b-quantity-of-snm .unnumbered}

1\. General Information

This section should state the following:

"The applicant's request, Reference number, for a new OTA or OTA
revision for the off-site shipment of SA BXX-X YYY (the weapon
designator and the Joint Test Assembly (JTA), Joint Test Subassembly
(JTS), Flight Test Unit (FTU), Laboratory Test Unit (LTU), etc. SA
designators) and its supporting HAR, Reference number, were reviewed in
accordance to DOE Order 461.1A and SG 500." "Because the amount of
radioactive material in this unit is not a Type B quantity, a
Transportation System Risk Assessment is not required."

"The hazardous material information provided in the HAR has been
reviewed and has been determined to be acceptable for issuing the OTA.
This SER supports OTA **DOE/NNSA**/XXXXXX/JTA. If the SER is a revision
of a previous SER, this paragraph should identify the reason for
changing the SER and OTA (e.g., change of authorized SA, changes of
components or their hazardous material constituents, changes in shipping
configurations or mode of transport, etc.)."

2\. Description of Units

This section should provide the following:

"The special assemblies addressed in this SER are NELAs."

This section should indicate whether the SA(s)/SA variant(s) addressed
in this SER will be pre- and post-test configurations or just pre-test
or just post-test, and shall also identify the handling gear or
packaging for each of the configurations authorized.

This section should also provide a short description of the SA
variant(s) addressed in the SER, and each of the delivery modes that the
SA(s) may be tested under and what the physical differences among the
units are for the different delivery modes.

This section should also list the shipments origination and destination
points and the modes of transportation that are authorized and any modes
of transportation that are prohibited

3\. Drawing Definition

The following table lists the SA variant and its associated top level
drawing and part numbers:

  -------------------------------- --------------------------------------
  SA Variant                       Top Level Part/Drawing Number

  BXX JTA 10                       678945/AY92854\*
  -------------------------------- --------------------------------------

\* Used for example purposes only

Notes to convey other information may be used to supplement this table.

4\. Hazardous Materials Analysis

This section should provide the following:

"The pre-test and planned post-test (if needed) TP 20-11, Reference Y,
hazardous materials categories/designators for the SA variant(s)
addressed in this SER are provided in the following Table."

+----------------------+------------------------+----------------------+
| Pre-test and         |                        |                      |
| Post-test (if        |                        |                      |
| shipment of          |                        |                      |
| post-test            |                        |                      |
| configuration is     |                        |                      |
| planned) BXX-X JTA   |                        |                      |
| 10 (the weapon       |                        |                      |
| designator and the   |                        |                      |
| JTA, JTS, FTU, etc.  |                        |                      |
| SA designators)      |                        |                      |
| TP20-11 Hazardous    |                        |                      |
| Materials            |                        |                      |
| Ca                   |                        |                      |
| tegories/Designators |                        |                      |
+----------------------+------------------------+----------------------+
| SA Variant           | Pre-test               | Planned Post-test    |
|                      | Categories/Designators | Ca                   |
|                      |                        | tegories/Designators |
|                      |                        |                      |
|                      |                        | (if needed)          |
+----------------------+------------------------+----------------------+
| BXX-X JTA 10         | Category/designator    | Category/designator  |
|                      | from TP 20-11          | from TP 20-11        |
+----------------------+------------------------+----------------------+

Notes to convey additional information may be used to supplement this
table.

"The hazardous materials contained in the SA(s) addressed in this SER
are contained within DOE/NNSA components and are packaged in strong,
tight envelopes that will not release any of the hazardous materials
during conditions normal to transport. For post-test units, the test
engineer is required by the OTA to inspect the unit to ensure that it is
in a condition that is safe to transport prior to offering the unit for
shipment."

"The following table lists SA variant(s), the identity of every
component that contains hazardous materials and its association with the
SA variant(s), the planned post-test (if applicable) status of each of
the components, and the identity and quantity of each of the hazardous
materials constituents of each component. Part numbers are required for
all units built at or shipped to the Pantex Plant."

+---------------+---+------------------+---------+------+-------+-------+
| SA Hazardous  |   |                  |         |      |       |       |
| Materials\*   |   |                  |         |      |       |       |
+---------------+---+------------------+---------+------+-------+-------+
| Component     |   | Hazardous        | Planned | Var  |       |       |
|               |   | Material         |         | iant |       |       |
|               |   | Description and  | Po      |      |       |       |
|               |   | Quantity         | st-test | (To  |       |       |
|               |   |                  |         | w    |       |       |
|               |   |                  | Status  | hich |       |       |
|               |   |                  |         | the  |       |       |
|               |   |                  |         | li   |       |       |
|               |   |                  |         | sted |       |       |
|               |   |                  |         | c    |       |       |
|               |   |                  |         | ompo |       |       |
|               |   |                  |         | nent |       |       |
|               |   |                  |         | appl |       |       |
|               |   |                  |         | ies) |       |       |
+---------------+---+------------------+---------+------+-------+-------+
|               |   |                  |         | JTA  | EFI-A | JTA2  |
|               |   |                  |         | 1    |       |       |
+---------------+---+------------------+---------+------+-------+-------+
| Identity of   |   |                  |         |      |       |       |
| Major         |   |                  |         |      |       |       |
| Subassembly   |   |                  |         |      |       |       |
| (e.g., JTA2   |   |                  |         |      |       |       |
| Telemetry     |   |                  |         |      |       |       |
| Assembly)     |   |                  |         |      |       |       |
+---------------+---+------------------+---------+------+-------+-------+
| MC XXXX       |   | X.X mg Explosive | E       |      |       | X     |
| Actuator      |   | A                | xpended |      |       |       |
|               |   |                  |         |      |       |       |
| (Part Number) |   |                  |         |      |       |       |
+---------------+---+------------------+---------+------+-------+-------+
| MC XXXX       |   | X.X g Lithium    | No      | X    |       | X     |
|               |   |                  | Change  |      |       |       |
| (Part Number) |   | X.X g            |         |      |       |       |
|               |   | Lithium/Mercury  | No      |      |       |       |
| **or**        |   | Compound         | Change  |      |       |       |
|               |   |                  |         |      |       |       |
| MC YYYY       |   |                  |         |      |       |       |
|               |   |                  |         |      |       |       |
| (Part Number) |   |                  |         |      |       |       |
+---------------+---+------------------+---------+------+-------+-------+
| Identity of   |   |                  |         |      |       |       |
| Major         |   |                  |         |      |       |       |
| Subassembly   |   |                  |         |      |       |       |
| (e.g.,        |   |                  |         |      |       |       |
| Witness Plate |   |                  |         |      |       |       |
| Assembly)     |   |                  |         |      |       |       |
+---------------+---+------------------+---------+------+-------+-------+
| MC XXXX       | X |                  | E       |      | X     |       |
|               | X |                  | xpended |      |       |       |
| (Part Number) | X |                  |         |      |       |       |
|               | m |                  |         |      |       |       |
|               | g |                  |         |      |       |       |
|               | E |                  |         |      |       |       |
|               | x |                  |         |      |       |       |
|               | p |                  |         |      |       |       |
|               | l |                  |         |      |       |       |
|               | o |                  |         |      |       |       |
|               | s |                  |         |      |       |       |
|               | i |                  |         |      |       |       |
|               | v |                  |         |      |       |       |
|               | e |                  |         |      |       |       |
|               | Z |                  |         |      |       |       |
+---------------+---+------------------+---------+------+-------+-------+

\* The information contained in the table is for examples only.

Notes to convey additional information may be used to supplement this
table.

5\. Packaging and Transportation

"The pre-test BXX-X (and other SA(s) addressed in the SER) are
transported in the HXXXX Bomb Cradle and are secured in the transport
conveyance using XXXXXX (e.g., TP 45-51, Technical Manual *Tiedown
Procedures for Type-B Containers Shipped in Safe-Secure
Trailer/Safeguards Transporter (SST/SGT),* and/or Technical Manual
*DOE/TSD Aircraft Cargo Tiedown Manual*, as applicable)."

After the BXX-X (and other SA(s) addressed in the SER) undergoes the
planned test, the Sandia test director shall determine whether the test
was normal and utilize the Sandia procedure SPXXXX (e.g., SP472837, *B83
Joint Test Assembly and Type --3E Post-test Inspection at the Tonopah
Test Range*) to recover the unit. The procedure outlines the hazards
posed by the unit and methods used to recover the unit(s). It is also
used to inform personnel of the external hazards that exist or may exist
after a normal and abnormal test. DOE/NNSA PCD must be notified prior to
offering the post-test unit for shipment anytime observations during the
test or the post-test inspection indicate that the unit experienced an
abnormal test. DOE/NNSA PCD shall perform a safety assessment of the
unit and authorize its shipment before it can be offered for shipment.
The DOE/NNSA PCD assessment may include the development and imposition
of additional administrative measures that are designed to mitigate the
hazards associated with the post-test unit.

This section will also identify applicable transportation restrictions
(e.g., "The pre-test and post-test shipments will be made via the TSS".
"These units shall be transported via ground transport only.").

### 6. Conclusions {#conclusions .TextBold .unnumbered}

This section should provide a recommendation to approve or disapprove
the OTA request (e.g., "The risk posed by the shipment of these units is
within the safety and security bases of the TSS and should be
authorized.").

> 7\. References
>
> This section should list the memorandum submitted to request the OTA
> or OTA revision, the HAR, applicable tiedown manuals, TP 20-11 and all
> other publications used to develop the SER.

## 4.0 Guide for Developing SERs for Special Assemblies that Contain {#guide-for-developing-sers-for-special-assemblies-that-contain .unnumbered}

##  Type B Quantity RAM {#type-b-quantity-ram-1 .unnumbered}

> The SER for SAs that contain Type B quantity of RAM is a hybrid of a
> SER for a TSRA as described in Section 2 of this Appendix and for a
> HAR as described in Section 3 of this Appendix and must address all of
> the areas addressed by those two types of SERs.

###  {#section-36 .TextBold .unnumbered}

### 5.0 TSRP Process {#tsrp-process .TextBold .unnumbered}

The PCD Manager, in coordination with the PCD staff and in advance of
the start of a TSRP review:

**A.** Establishes procedures to witness/inspect any field per­formance
tests on which the determination of packaging adequacy is based.

**B.** Witnesses/inspects any field per­formance tests on which the
determination of packaging adequacy is based.

**C.** Ensures that all procedures required by DOE/NNSA contractor QAPP
are identified to the TSRP.

**D.** Verifies that the contractor-performed inspections that will be
used during package processing are documented in the procurement
paperwork (10 CFR 71.109). This documentation is required from DOE
Category A or B vendors and should include the vendor\'s quality
assurance plan and other quality assurance records (10 CFR 71.101-105).
These documents should be available for review by DOE/NNSA upon request
(10 CFR 71.101-105), and should show in-depth, clear compliance with
regulatory and/or standards and criteria requirem­ents (10 CFR
71.101-105).

**E.** Assigns organization that will perform the confirmatory review.

The applicant submits one copy of the draft SARP/TSRA to the Package
Line Manager/Weapons System Program Manager, as applicable, and four
copies to the recipients identified on a list provided by DOE/NNSA PCD.

TSRP chairperson convenes the TSRP.

TSRP conducts review and reports the results.

**6.0** []{#Appendix_C_Developing_OTAs_and_OTCs .anchor}**Guidance for
Developing OTAs and OTCs**

An OTA may be issued for a one-time shipment or for a transportation
campaign covering a period of time not to exceed five years. An OTC may
be issued for a period of time not to exceed five years. Each OTA/OTC is
assigned a unique number and that number will not change throughout the
life of that particular OTA/OTC. The original version of each OTA/OTC is
assigned revision number zero and each subsequent change to the OTA/OTC
will result in a change to the revision number. Section 3 of the OTC
must list the SARP and supporting documents (for OTCs), or the TSRA (if
applicable) and/or HAR (for OTA), and applicant's correspondences and/or
other documents that contain data/information relative to the operations
authorized by the OTA/OTC. Section 7.a shall provide a short description
of the packaging/handling gear. Section 7.b shall identify the contents
that are authorized to be shipped under the OTA/OTC. Information in this
section and/or in the documents that this section may refer the user to,
shall be definitive and unambiguous. Section 7.c shall contain a list of
transportation and handling restrictions that are applicable to the
operations authorized under the OTA/OTC. For example, it will list the
type(s) of off-site transportation conveyance that is authorized to
perform the off-site transportation operations authorized, direct the
user to secure the items in the transport vehicle using the tiedown
documents specified, provide marking and labeling requirements, require
the person in charge of providing security during the transportation to
have a copy of the OTA/OTC, specify conditions of operation including
transporter and shipment configuration, positive measures,
administrative controls, and declared maximum number of specified
shipments per calendar year and various other restrictions that are
specific to the operations authorized under the OTA/OTC. Section 7.d may
include a listing of documents such as tiedown manuals, TP 20-11
(Firefighting Guide), etc. that may be referenced in the OTA/OTC. The
following OTA and OTC are provided as examples:

U. S. Department of Energy

DOE/NNSA Service Center

**OFFSITE TRANSPORTATION CERTIFICATE**

+------------------------+--------------+-------+-------------+----+---+
| 1a. Certificate Number | 1b. Revision | 1c.   |             |    |   |
|                        | Number       | Total |             |    |   |
| > **DOE/NNSA/2003XX    |              | No.   |             |    |   |
| > for new OTC or       | \- \# -      | Pages |             |    |   |
| > DOE/AL/2002XX for a  |              |       |             |    |   |
| > revision of an OTC** |              | \- \# |             |    |   |
|                        |              | -     |             |    |   |
+------------------------+--------------+-------+-------------+----+---+
| 2\. This Certificate   |              |       |             |    |   |
| is issued pursuant to  |              |       |             |    |   |
| 49 CFR 173.7 (d), DOE  |              |       |             |    |   |
| Order 461.1A,          |              |       |             |    |   |
| Reference 7.d.1.       |              |       |             |    |   |
| Willful violation of   |              |       |             |    |   |
| the provisions of this |              |       |             |    |   |
| Certificate is subject |              |       |             |    |   |
| to action under Title  |              |       |             |    |   |
| 49 U.S.C. 1809(b).     |              |       |             |    |   |
+------------------------+--------------+-------+-------------+----+---+
| 3\. This Certificate   |              |       |             |    |   |
| is issued on the basis |              |       |             |    |   |
| of the following       |              |       |             |    |   |
| Safety Analysis Report |              |       |             |    |   |
| for Packaging (SARP),  |              |       |             |    |   |
| SARP supporting        |              |       |             |    |   |
| documents listed       |              |       |             |    |   |
| below, and the Safety  |              |       |             |    |   |
| Evaluation Report for  |              |       |             |    |   |
| the H1616 Package:     |              |       |             |    |   |
|                        |              |       |             |    |   |
| a.  Title and issue    |              |       |             |    |   |
|     date of SARP.      |              |       |             |    |   |
|                        |              |       |             |    |   |
| b.  Title and issue    |              |       |             |    |   |
|     dates of           |              |       |             |    |   |
|     associated         |              |       |             |    |   |
|     documents. For     |              |       |             |    |   |
|     example, the       |              |       |             |    |   |
|     additional         |              |       |             |    |   |
|     documents listed   |              |       |             |    |   |
|     could be the SR,   |              |       |             |    |   |
|     SARP               |              |       |             |    |   |
|     Attachment(s),     |              |       |             |    |   |
|     SARP Addendum(s)   |              |       |             |    |   |
|     and the SER        |              |       |             |    |   |
+------------------------+--------------+-------+-------------+----+---+
| 4\. The packaging and  |              |       |             |    |   |
| contents described in  |              |       |             |    |   |
| the SARP and further   |              |       |             |    |   |
| described in Item 7    |              |       |             |    |   |
| must meet the          |              |       |             |    |   |
| standards prescribed   |              |       |             |    |   |
| in Item 2 above.       |              |       |             |    |   |
+------------------------+--------------+-------+-------------+----+---+
| 5\. Containers and/or  |              |       |             |    |   |
| shipping papers will   |              |       |             |    |   |
| be identified by the   |              |       |             |    |   |
| Certificate Number     |              |       |             |    |   |
| shown in Item 1a. on   |              |       |             |    |   |
| this form.             |              |       |             |    |   |
+------------------------+--------------+-------+-------------+----+---+
| 6\. This Certificate   |              |       |             |    |   |
| does not relieve the   |              |       |             |    |   |
| consignor from         |              |       |             |    |   |
| compliance with        |              |       |             |    |   |
| applicable             |              |       |             |    |   |
| requirements of the    |              |       |             |    |   |
| regulations of the U.  |              |       |             |    |   |
| S. Department of       |              |       |             |    |   |
| Transportation or      |              |       |             |    |   |
| other applicable       |              |       |             |    |   |
| regulatory agencies    |              |       |             |    |   |
| except as noted in     |              |       |             |    |   |
| Item 7c on this form.  |              |       |             |    |   |
+------------------------+--------------+-------+-------------+----+---+
| 7\. Description of     |              |       |             |    |   |
| Packaging and          |              |       |             |    |   |
| Authorized Contents,   |              |       |             |    |   |
| Restrictions and       |              |       |             |    |   |
| References:            |              |       |             |    |   |
|                        |              |       |             |    |   |
| a\. **[Description of  |              |       |             |    |   |
| Pac                    |              |       |             |    |   |
| kaging:]{.underline}** |              |       |             |    |   |
|                        |              |       |             |    |   |
| Provide short          |              |       |             |    |   |
| description of the     |              |       |             |    |   |
| packaging to include   |              |       |             |    |   |
| the packaging's        |              |       |             |    |   |
| identity, composition  |              |       |             |    |   |
| and dimensions.. For   |              |       |             |    |   |
| example: AL-SX/2       |              |       |             |    |   |
| (H1616-1), etc. Both   |              |       |             |    |   |
| consist of a stainless |              |       |             |    |   |
| steel outer drum lined |              |       |             |    |   |
| with a 0.5-inch thick  |              |       |             |    |   |
| high-performance       |              |       |             |    |   |
| alumina silica ceramic |              |       |             |    |   |
| fiber thermal barrier  |              |       |             |    |   |
| and rigid polyurethane |              |       |             |    |   |
| foam. An approximately |              |       |             |    |   |
| 0.030 inch thick       |              |       |             |    |   |
| stainless steel liner  |              |       |             |    |   |
| that encapsulates the  |              |       |             |    |   |
| thermal barrier and    |              |       |             |    |   |
| polyurethane foam is   |              |       |             |    |   |
| welded to the drum.    |              |       |             |    |   |
| The stainless steel    |              |       |             |    |   |
| liner is shaped to     |              |       |             |    |   |
| accept a stainless     |              |       |             |    |   |
| steel containment      |              |       |             |    |   |
| vessel. The drum and   |              |       |             |    |   |
| outer lid are          |              |       |             |    |   |
| manufactured from      |              |       |             |    |   |
| 18-gauge 304 stainless |              |       |             |    |   |
| steel. The drum's size |              |       |             |    |   |
| is 16 gallons and its  |              |       |             |    |   |
| dimensions are 21.3    |              |       |             |    |   |
| inches high and 16.4   |              |       |             |    |   |
| inches in diameter.    |              |       |             |    |   |
| The drum lid is        |              |       |             |    |   |
| secured to the drum    |              |       |             |    |   |
| body by a stainless    |              |       |             |    |   |
| steel locking ring     |              |       |             |    |   |
| with a 0.375 diameter  |              |       |             |    |   |
| bolt and nut. The      |              |       |             |    |   |
| containment vessel is  |              |       |             |    |   |
| made from 304          |              |       |             |    |   |
| austenitic steel. The  |              |       |             |    |   |
| H1616-1 containment    |              |       |             |    |   |
| vessel's inner         |              |       |             |    |   |
| diameter is 12.16      |              |       |             |    |   |
| inches and its height  |              |       |             |    |   |
| is 14.3 inches. The    |              |       |             |    |   |
| H1616-2 containment    |              |       |             |    |   |
| vessel's inner ...     |              |       |             |    |   |
+------------------------+--------------+-------+-------------+----+---+
| 8a. Address of DOE     |              |       | 8b.         |    |   |
| Certifying Authority:  |              |       | Signature   |    |   |
|                        |              |       |             |    |   |
| **U. S. Department of  |              |       |             |    |   |
| Energy**               |              |       |             |    |   |
|                        |              |       |             |    |   |
| **National Nuclear     |              |       |             |    |   |
| Security               |              |       |             |    |   |
| Administration**       |              |       |             |    |   |
|                        |              |       |             |    |   |
| **DOE/NNSA Service     |              |       |             |    |   |
| Center**               |              |       |             |    |   |
|                        |              |       |             |    |   |
| > **P.O. Box 5400**    |              |       |             |    |   |
| >                      |              |       |             |    |   |
| > **Albuquerque, New   |              |       |             |    |   |
| > Mexico 87185-5400**  |              |       |             |    |   |
+------------------------+--------------+-------+-------------+----+---+
|                        |              |       | 8c. Name    |    |   |
|                        |              |       | and Title   |    |   |
|                        |              |       |             |    |   |
|                        |              |       | **Name and  |    |   |
|                        |              |       | title of    |    |   |
|                        |              |       | Certifying  |    |   |
|                        |              |       | Official**  |    |   |
+------------------------+--------------+-------+-------------+----+---+
|                        |              |       | 9\.         | 10 |   |
|                        |              |       | Expiration  | \. |   |
|                        |              |       | Date        | Da |   |
|                        |              |       |             | te |   |
+------------------------+--------------+-------+-------------+----+---+

7.b. **[Authorized Contents]{.underline}**

This section must provide a short description of the authorized content.
The description must be sufficiently definitive to preclude anyone from
misinterpreting what is authorized to be shipped under this OTC.

7.c. **[Transportation and Handling Restrictions]{.underline}**

1.  Under the authority of DOE Order 461.1A, this shipment is made for
    the purpose of national security. These shipments must be escorted
    by personnel specifically designated by the DOE, and the OTC must be
    in the possession of the person in charge of providing security
    during transportation. These packages must be transported off site
    via the TSS.

2.  These packages may be transported in -- *the identity of the
    authorized conveyance* - (For example air and ground, ground only,
    etc.). For transportation via ground, the escorts shall be in a
    separate vehicle from that carrying the packages authorized under
    this OTC.

3.  These packages shall not be transported in the same conveyance with
    nuclear weapons, nuclear explosives, or other DOE, NRC, or
    DOT-regulated quantities of hazardous material except for nuclear
    weapon components or radioactive material contained in certified
    Type B packages.

4.  The - *identity of the package authorized under this OTC* - users
    must be specifically approved by the DOE/NNSA PCD prior to any use
    of these packages. Site specific operating procedures approved by
    DOE/NNSA PCD and DOE/NNSA approved QAPPs must be used for all
    operations with these packages. The operating procedures shall be in
    accordance with the SARP and -- list other pertinent documents --
    (For example SS393218 for the H1616.).

5.  Each package must be inspected prior to loading the authorized
    contents and off-site shipment.

6.  List of package specific restrictions/requirements.

7.  A radiological survey must be conducted on each package; validation
    that the survey was performed must be communicated to the package
    destination and retained by the shipper as part of the shipment
    records. Surface contamination on any part of the package must not
    exceed the limits specified in 49 CFR 173.443, Table 11. Emanations
    must not exceed the limits specified in 49 CFR 173.441. Measuring
    equipment used for surveys must be calibrated and of sufficient
    accuracy.

8.  Exterior package marking and labeling must be legible and visible
    and in conformance with 49 CFR 172, Sections D and E (49 CFR 172.310
    and 172.403 (c)) except that classified information shall not be
    revealed.

9.  The package shall be secured in the transport conveyance in
    accordance with the procedures contained in the -- *list of
    documents that contain the applicable approved tiedown procedures
    for the package and conveyance(s) authorized under the OTA* - (For
    example: *DOE/TSD Aircraft Cargo Tiedown Manual*, Reference 7.d.3,
    *Tiedown Procedures for Type-B Containers*, Reference 7.d.4 or TP
    45-51D, Reference 7.d.5, as applicable).

7.d. **[References]{.underline}**

List DOE Order 461.1A, tiedown manuals referenced and other documents,
as applicable.

U. S. Department of Energy

DOE/NNSA Service Center

**OFFSITE TRANSPORTATION AUTHORIZATION**

+----------------------------------------+-----+----------+-------+---+
| 1a. Authorization Number               | 1b. |          | 1c.   |   |
|                                        | Re  |          | Total |   |
| > **DOE/NNSA/2003XX for new OTA or     | vis |          | No.   |   |
| > DOE/AL/2002XX for a revision of an   | ion |          | Pages |   |
| > OTA**                                | Num |          |       |   |
|                                        | ber |          | \- \# |   |
|                                        |     |          | -     |   |
|                                        | \-  |          |       |   |
|                                        | \#  |          |       |   |
|                                        | -   |          |       |   |
+----------------------------------------+-----+----------+-------+---+
| 2\. This Authorization is issued       |     |          |       |   |
| pursuant to 49 CFR 173.7 (b), DOE      |     |          |       |   |
| Order 461.1A, Reference 7.d.1. Willful |     |          |       |   |
| violation of the provisions of this    |     |          |       |   |
| Authorization is subject to action     |     |          |       |   |
| under Title 49 U.S.C. 1809(b).         |     |          |       |   |
+----------------------------------------+-----+----------+-------+---+
| 3\. This Authorization is issued on    |     |          |       |   |
| the basis of the following Safety      |     |          |       |   |
| Analysis Report for Packaging (SARP);  |     |          |       |   |
| SARP supporting documents 3.b, 3.c,    |     |          |       |   |
| and 3.d; the Transportation System     |     |          |       |   |
| Risk Assessment listed in 3.e; and the |     |          |       |   |
| Safety Evaluation Report for the H1616 |     |          |       |   |
| Package in 3.f:                        |     |          |       |   |
|                                        |     |          |       |   |
| **For a package:**                     |     |          |       |   |
|                                        |     |          |       |   |
| a.  Titles and issue dates of the SARP |     |          |       |   |
|     and TSRA.                          |     |          |       |   |
|                                        |     |          |       |   |
| b.  Title and issue dates of           |     |          |       |   |
|     associated documents. For example, |     |          |       |   |
|     the additional documents listed    |     |          |       |   |
|     could be the SR, SARP              |     |          |       |   |
|     Attachment(s), SARP Addendum(s)    |     |          |       |   |
|     and the SER.                       |     |          |       |   |
|                                        |     |          |       |   |
| **For HiFi (Contains Type B quantity   |     |          |       |   |
| of RAM) NELAs:**                       |     |          |       |   |
|                                        |     |          |       |   |
| a\. Title and issue date of the TSRA   |     |          |       |   |
| and the SER.                           |     |          |       |   |
|                                        |     |          |       |   |
| **For other (Contains Type A quantity  |     |          |       |   |
| or no RAM) NELAs:**                    |     |          |       |   |
|                                        |     |          |       |   |
| The title(s) and issue date(s) of the  |     |          |       |   |
| applicable HAR(s), and the SER.        |     |          |       |   |
+----------------------------------------+-----+----------+-------+---+
| 4\. The packaging and contents         |     |          |       |   |
| described in the Hazards Analysis      |     |          |       |   |
| Report and further described in Item 7 |     |          |       |   |
| must meet the format and content       |     |          |       |   |
| specified in SG 500 for special        |     |          |       |   |
| assemblies or nuclear component        |     |          |       |   |
| shipments.                             |     |          |       |   |
+----------------------------------------+-----+----------+-------+---+
| 5\. As appropriate, containers and/or  |     |          |       |   |
| shipping papers will be identified by  |     |          |       |   |
| the Authorization Number shown in Item |     |          |       |   |
| 1a. on this form.                      |     |          |       |   |
+----------------------------------------+-----+----------+-------+---+
| 6\. This Authorization does not        |     |          |       |   |
| relieve the consignor from compliance  |     |          |       |   |
| with applicable requirements of the    |     |          |       |   |
| regulations of the U. S. Department of |     |          |       |   |
| Transportation or other applicable     |     |          |       |   |
| regulatory agencies.                   |     |          |       |   |
+----------------------------------------+-----+----------+-------+---+
| 7\. Description of Shipment and        |     |          |       |   |
| Authorized Contents, Restrictions, and |     |          |       |   |
| References:                            |     |          |       |   |
|                                        |     |          |       |   |
| a\. **[Description of                  |     |          |       |   |
| Packaging:]{.underline}**              |     |          |       |   |
|                                        |     |          |       |   |
| > This section must provide a short    |     |          |       |   |
| > description of the packaging or      |     |          |       |   |
| > handling gear and configurations     |     |          |       |   |
| > authorized under this OTA.           |     |          |       |   |
+----------------------------------------+-----+----------+-------+---+
| 8a. Address of DOE Certifying          |     | 8b.      |       |   |
| Authority:                             |     | S        |       |   |
|                                        |     | ignature |       |   |
| **U. S. Department of Energy**         |     |          |       |   |
|                                        |     |          |       |   |
| **National Nuclear Security            |     |          |       |   |
| Administration**                       |     |          |       |   |
|                                        |     |          |       |   |
| **NNSA Service Center**                |     |          |       |   |
|                                        |     |          |       |   |
| **P. O. Box 5400**                     |     |          |       |   |
|                                        |     |          |       |   |
| > **Albuquerque, New Mexico            |     |          |       |   |
| > 87185-5400**                         |     |          |       |   |
+----------------------------------------+-----+----------+-------+---+
|                                        |     | 8c. Name |       |   |
|                                        |     | and      |       |   |
|                                        |     | Title    |       |   |
|                                        |     |          |       |   |
|                                        |     | **Name   |       |   |
|                                        |     | and      |       |   |
|                                        |     | title of |       |   |
|                                        |     | Ce       |       |   |
|                                        |     | rtifying |       |   |
|                                        |     | Of       |       |   |
|                                        |     | ficial** |       |   |
+----------------------------------------+-----+----------+-------+---+
|                                        |     | 9\.      |       | 1 |
|                                        |     | Ex       |       | 0 |
|                                        |     | piration |       | \ |
|                                        |     | Date     |       | . |
|                                        |     |          |       | D |
|                                        |     |          |       | a |
|                                        |     |          |       | t |
|                                        |     |          |       | e |
+----------------------------------------+-----+----------+-------+---+

7.b. **[Authorized Contents]{.underline}**

This section must provide a short description of the authorized content.
The description must be sufficiently definitive to preclude anyone from
misinterpreting what is authorized to be shipped under this OTA. For
NELAs this paragraph should include the unit's high-level part and
drawing number.

7.c. **[Transportation and Handling Restrictions]{.underline}**

1.  Under the authority of DOE Order 461.1A, this shipment is made for
    the purpose of national security. These shipments must be escorted
    by personnel specifically designated by the DOE, and the OTA must be
    in the possession of the person in charge of providing security
    during transportation. These -- *identity of the packages or NELA,
    as applicable* - must be transported off site via the TSS.

2.  These -- *identity of the packages or NELAs - may be transported in
    -- the identity of the authorized conveyance* - (For example air and
    ground, ground only, etc.). For transportation via ground, the
    escorts shall be in a separate vehicle from that carrying the
    packages authorized under this OTA.

3.  These -- *identity of the packages or NELAs, as applicable* - shall
    not be transported in the same conveyance with nuclear weapons,
    nuclear explosives, or other DOE, NRC, or DOT-regulated quantities
    of hazardous material.

4.  For Packages:

> The - *identity of the package(s) authorized under this OTA* - users
> must be specifically approved by the DOE/NNSA PCD prior to any use of
> these packages. Site-specific operating procedures approved by
> DOE/NNSA PCD and DOE/NNSA approved QAPPs, must be used for all
> operations with these packages. The operating procedures shall be in
> accordance with the SARP and -- *list other pertinent documents* --
> (For example SS393218 for the H1616.).
>
> Each package must be inspected prior to loading the authorized
> contents and off-site shipment.
>
> List of package specific restrictions/requirements.

\(5\) For NELAs:

> The shipper and receiver are both responsible for ensuring that the
> receiving site is authorized to receive the type of NELA proposed for
> shipment prior to offering the NELA for shipment.
>
> This section of the OTA must list the TP 20-11 hazardous material
> designators/categories that are applicable to each of the NELAs
> variants and configurations authorized under this OTA. For example:

  ----------------------- ------------------------ -----------------------
  NELA Variant            TP 20 --11 Hazardous     
                          Material                 
                          Designators/Categories   

                          Pre-test                 Post-test

  BXX-4 JTA2              E-3, E-4, R-3            R-3
  ----------------------- ------------------------ -----------------------

\(6\) A radiological survey must be conducted on each package/NELA;
validation that the survey was performed must be communicated to the
package destination and retained by the shipper as part of the shipment
records. Surface contamination on any part of the package must not
exceed the limits specified in 49 CFR 173.443, Table 11. Emanations must
not exceed the limits specified in 49 CFR 173.441. Measuring equipment
used for surveys must be calibrated and of sufficient accuracy.

\(7\) Exterior package marking and labeling must be legible and visible
and in conformance with 49 CFR 172, Sections D and E (49 CFR 172.310 and
172.403 (c)) except that classified information shall not be revealed.

\(8\) The package or NELA, as applicable, shall be secured in the
transport conveyance in accordance with the procedures contained in the
-- *list of documents that contain the applicable approved tiedown
procedures for the package and conveyance(S) authorized under the OTA* -
(For example: *DOE/TSD Aircraft Cargo Tiedown Manual*, Reference 7.d.3,
*Tiedown Procedures for Type-B Containers*, Reference 7.d.4 or TP
45-51D, Reference 7.d.5, as applicable).

7.d. **[References]{.underline}**

List DOE Order 461.1A, tiedown manuals referenced and other documents as

applicable.

###  {#section-37 .TextBold .unnumbered}

###  {#section-38 .TextBold .unnumbered}

###  {#section-39 .TextBold .unnumbered}

###  {#section-40 .TextBold .unnumbered}

###  {#section-41 .TextBold .unnumbered}

###  {#section-42 .TextBold .unnumbered}

###  {#section-43 .TextBold .unnumbered}

###  {#section-44 .TextBold .unnumbered}

###  {#section-45 .TextBold .unnumbered}

### Appendix D {#appendix-d .TextBold .unnumbered}

###  {#section-46 .TextBold .unnumbered}

### PCD {#pcd .TextBold .unnumbered}

### Surveillance Process {#surveillance-process .TextBold .unnumbered}

###  {#section-47 .TextBold .unnumbered}

###  {#section-48 .TextBold .unnumbered}

###  {#section-49 .TextBold .unnumbered}

###  {#section-50 .TextBold .unnumbered}

###  {#section-51 .TextBold .unnumbered}

###  {#section-52 .TextBold .unnumbered}

###  {#section-53 .TextBold .unnumbered}

###  {#section-54 .TextBold .unnumbered}

###  {#section-55 .TextBold .unnumbered}

###  {#section-56 .TextBold .unnumbered}

**1.0** []{#Appendix_D_Intro .anchor}**Introduction**

Surveillance is the act of monitoring or observing to verify whether an
item or activity conforms to specified requirements.

This surveillance process provides the mechanism for PCD to ensure that
the users of its products (certified packages, OTA, OTC, etc.) have
programs and processes for ensuring that the requirements specified for
the use of the PCD products are correctly implemented. This surveillance
process is also designed to meet PCD oversight responsibilities
specified in DOE Order 461.1A.

**2.0** []{#Appendix_D_Surveillance_Process .anchor}**Surveillance
Process**

As the DOE/NNSA organization responsible for DOE/NNSA package
certifications and offsite transportation authorizations, PCD has the
responsibility to ensure that the users of these certified packages and
authorizations comply with the requirements contained in DOE/NNSA
Orders, federal requirements, SARPs, SERs, OTCs and/or OTAs, and other
supporting documents. The PCD will perform surveillances of OTC and OTA
users on an as needed basis. The following information is provided to
guide PCD in the performance of their surveillance responsibilities:

**A.** Activities of PCD Manager:

1\. Maintain cognizance of OTA and OTC users performance and their
compliance with the requirements specified for their use and conduct
surveillances of user sites as needed.

2\. Appoint Surveillance Team Leader and members when required.

3\. Meet with Surveillance Team Leader to assign and provide guidance on
tasking.

4\. Review and approve Surveillance Team's surveillance plan for high
profile/complex surveillance assignments, as needed.

5\. Approve surveillance report for distribution, and determine
distribution recipients.

6\. Oversee post-surveillance activities until all issues have been
resolved.

**B.** Activities of Surveillance Team Leader:

1\. Pre-surveillance Activities:

> a\. Review the requirements for the area(s)/activities which will be
> the focus of the surveillance.
>
> b\. Develop surveillance plan that contains a checklist and proposed
> initial inquiries for the areas which will undergo the surveillance.
>
> c\. Identify principal point of contact and subject matter points of
> contact at the site undergoing the surveillance.
>
> d\. Develop draft agenda.
>
> e\. Work with the site's principal point of contact to finalize agenda
> and to pair the surveillance team members with the site's subject
> matter points of contact at specified times.
>
> f\. Present proposed plan to PCD Manager for approval.
>
> g\. Provide copies of agenda, surveillance plan and subject
> matter/team member pairings to the site's principal point of contact
> and the surveillance team members.

2\. On-site Surveillance Activities:

> a\. Conduct in-brief for the surveillance team, and the site's points
> of contact and management to convey the purpose of the surveillance,
> the areas to be reviewed and the responsibilities of the participants.
>
> b\. Perform surveillance as scheduled.
>
> c\. Keep PCD Manager advised of surveillance activities.
>
> d\. Conduct out-brief for surveillance team, and site's points of
> contact and management to convey the outcome of the surveillance.

3\. Post Surveillance Activities:

a.  Prepare surveillance report and distribute to the PCD Manager and
    the management of the site that underwent the surveillance.

b.  Lead post-surveillance activities until all issues have been
    resolved.

###  {#section-57 .TextBold .unnumbered}

###  {#section-58 .TextBold .unnumbered}

###  {#section-59 .TextBold .unnumbered}

###  {#section-60 .TextBold .unnumbered}

###  {#section-61 .TextBold .unnumbered}

###  {#section-62 .TextBold .unnumbered}

###  {#section-63 .TextBold .unnumbered}

###  {#section-64 .TextBold .unnumbered}

###  {#section-65 .TextBold .unnumbered}

###  {#section-66 .TextBold .unnumbered}

### Appendix E {#appendix-e .TextBold .unnumbered}

###  {#section-67 .TextBold .unnumbered}

### PCD Web Page  {#pcd-web-page .TextBold .unnumbered}

###  {#section-68 .TextBold .unnumbered}

###  {#section-69 .TextBold .unnumbered}

###  {#section-70 .TextBold .unnumbered}

###  {#section-71 .TextBold .unnumbered}

###  {#section-72 .TextBold .unnumbered}

###  {#section-73 .TextBold .unnumbered}

###  {#section-74 .TextBold .unnumbered}

###  {#section-75 .TextBold .unnumbered}

###  {#section-76 .TextBold .unnumbered}

###  {#section-77 .TextBold .unnumbered}

**1.0** []{#Appendix_E_Intro .anchor}**Introduction**

The Web Page provides tables that lists the current OTCs , OTAs and
their respective issue and expiration dates, applicable SARPs and/or
TSRAs, graphics of applicable certified containers, approved package
users, and the DOE/NNSA Service Center points of contact for the Web
Page.

The guidance provided in this Appendix is to assist the PCD maintain a
Web Page that contains information that is useful to our customers, and
is current and accurate. The PCD is committed to maintaining a Web Page
that provides a wide array of useful information to our customers.

**2.0** []{#Appendix_E_Web_Master_Responsibilities .anchor}**Web Page
Master Responsibilities**

**A.** Revise Web Page as needed by using Microsoft FrontPage software
to update Web Page files.

**B.** Notify the Albuquerque (AL) Publish group via e-mail when any Web
Page file is updated and ask them post the change to the Web Page.

**C.** Notify Web Page customers via e-mail of any significant changes
to the Web Page.

**3.0** []{#Appendix_E_Modifying_data_on_Web_Page .anchor}**Modifying
Data on Web Page**

A.  Activate FrontPage Software

B.  Open NNSA-OTA Web Page

C.  Double Click on folder that contains the data that must be changed

D.  Change the data as needed

E.  Save file with changes

F.  Close and exit FrontPage

G.  Send e-mail message to Publish group to inform them that you have
    made changes to the NNSA-OTA Web Page files and ask them to post the
    changes.

**3.1** []{#Appendix_E_Container_Designator .anchor}**Linking Certified
Container Designator in OTC File (table) to File that Contains Container
Information**

A.  Activate FrontPage Software

B.  Open NNSA-OTA Web Page

C.  Double Click on OTC_update.htm

D.  Double Click on container designator that needs to be linked to its
    data sheet

E.  Select *Create or Edit Hyperlink*

F.  Go to Container ID Folder

G.  Highlight file that contains the container data

H.  Click OK

I.  Save

J.  Notify the Albuquerque (AL) Publish group via e-mail when any Web
    Page file is updated and ask them post the change to the Web Page.

```{=html}
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4.  []{#Appendix_E_CE_Responsibilities .anchor}**CEs Responsibilities**

**A.** Notify Web Master of OTA/OTC undergoing review/revision.

**B.** Provide the following information to the Web Page Master when new
or revised OTCs/OTAs are issued:

1\. OTA/OTC number, OTC/OTA revision number, issue date, expiration
date, plus the following:

> a\. For current OTC: changes in SARP owner, changes in SARP revision
> (SARP identifying information), Sites approved to perform packaging
> maintenance, Sites approved to provide packaging supplies, and number
> of packagings in service.
>
> b\. For new OTC: SARP owner, SARP identifying information, Sites
> approved to perform packaging maintenance, Sites approved to provide
> packaging supplies, number of packagings manufactured, number of
> packagings in service, package's highest approved gross weight, empty
> weight, external height and diameter and cavity height and diameter,
> and electronic graphic of the packagings.

**C.** Provide updates to the Web Master any time they lead activities
that result in changes to the information contained in the PCD Web Page.

5.  []{#Appendix_E_Users_ServiceResponsibilities .anchor}**Web Page
    Users Services and Responsibilities**

```{=html}
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```
A.  Refer to Web Page to determine:

    1.  Current OTAs and OTCs, their revision numbers, issue dates and
        expiration dates.

    2.  Organizations that are Authorized Users of a specific OTC and
        associated certified package.

    3.  Brief descriptions of DOE/NNSA certified packagings.

    4.  Basic dimensions, and maximum approved gross and empty weights
        of DOE/NNSA certified packagings.

    5.  Sites approved to perform maintenance on DOE/NNSA certified
        packagings.

    6.  Sites approved to provide supplies for DOE/NNSA certified
        packaging.

    7.  SARP owner and identification of current SARP.

    8.  Number of certified packagings manufactured.

    9.  Approximate certified packagings in service.

    10. Information to indicate that a current OTA/OTC is undergoing
        review/revision.

**B.** Provide PCD suggested changes and/or additions to the information
contained in the Web Page.

**C.** Contact the PCD Web Page Master with any questions via the e-mail
or telephone listed on the Web Page.

###  {#section-78 .TextBold .unnumbered}

###  {#section-79 .TextBold .unnumbered}

###  {#section-80 .TextBold .unnumbered}

###  {#section-81 .TextBold .unnumbered}

###  {#section-82 .TextBold .unnumbered}

###  {#section-83 .TextBold .unnumbered}

###  {#section-84 .TextBold .unnumbered}

###  {#section-85 .TextBold .unnumbered}

### Appendix F {#appendix-f .TextBold .unnumbered}

###  {#section-86 .TextBold .unnumbered}

### Guide {#guide-3 .TextBold .unnumbered}

### for {#for-3 .TextBold .unnumbered}

### Developing a Scope of Work (SOW) {#developing-a-scope-of-work-sow .TextBold .unnumbered}

###  and for {#and-for .TextBold .unnumbered}

### Developing the Support Contractor's Monthly Report  {#developing-the-support-contractors-monthly-report .TextBold .unnumbered}

###  {#section-87 .TextBold .unnumbered}

###  {#section-88 .TextBold .unnumbered}

###  {#section-89 .TextBold .unnumbered}

###  {#section-90 .TextBold .unnumbered}

###  {#section-91 .TextBold .unnumbered}

###  {#section-92 .TextBold .unnumbered}

###  {#section-93 .TextBold .unnumbered}

###  {#section-94 .TextBold .unnumbered}

###  {#section-95 .TextBold .unnumbered}

###  {#section-96 .TextBold .unnumbered}

**1.0** []{#Appendix_F_Intro .anchor}**Introduction**

The guidance provided in this Appendix is to assist the PCD in
developing scopes of work for technical support contractors, and to
provide guidance to the technical support contractor on the required
content of the Monthly Activity Report.

**2.0** []{#Appendix_F_Scope_of_Work .anchor}**Scope of Work Outline**

The following outline should be used by the PCD to develop a SOW for
tasking contractors.

[Objective]{.underline}: Reference to DOE Order 461.1A, guidance and
standards, support for organization, workspace, security classification
level of tasks, computer skills, document storage requirements.

[Scope and Technical Requirements]{.underline}: a break out of specific
elements included in the task.

[Background]{.underline}: providing subject matter experts for specific
support.

[Tasks]{.underline}: Describe each functional task

[Travel]{.underline}: Indicate locations where travel is expected to
perform the tasks.

[Security Clearance]{.underline}: Requirements for clearance level
needed (i.e., "Q" or "L") and Need to Know and locations where work is
performed.

[Schedule and Deliveries]{.underline}: Period of performance with an
identification of fiscal years for tasks.

[Key Personnel]{.underline}: Identify essential technical personnel that
are required to perform the tasks that will be required by the SOW.

[Level of Effort]{.underline}: The number of hours assigned to the task
involved.

[Cost Estimate]{.underline}: by fiscal Year.

**3.0** []{#Appendix_F_Support_Contractor_Monthly_Rp .anchor}**Support
Contractor's Monthly Report Outline**

The following outline should be used by PCD support contractor to
develop their required monthly activity report.

[Reference assigned tasks.]{.underline}

[Scope, Schedule, and Status of Deliverables]{.underline}:(Usually in a
table format).

[Cost Summary:]{.underline} (By fiscal year (FY) funds provided for the
approved Work Scope, any prior FY carry-over funds, funds approved for
the assigned task, and funds expended during the monthly reporting
period, as well as cumulative totals to date, - usually a table).

[Open Items and Status of Work:]{.underline} (By task providing only a
highlight sentence).

[Distribution]{.underline}: Program Manager and each Project Engineer
that the task supports.

###  {#section-97 .TextBold .unnumbered}

###  {#section-98 .TextBold .unnumbered}

###  {#section-99 .TextBold .unnumbered}

###  {#section-100 .TextBold .unnumbered}

###  {#section-101 .TextBold .unnumbered}

###  {#section-102 .TextBold .unnumbered}

###  {#section-103 .TextBold .unnumbered}

###  {#section-104 .TextBold .unnumbered}

###  {#section-105 .TextBold .unnumbered}

### Appendix G {#appendix-g .TextBold .unnumbered}

###  {#section-106 .TextBold .unnumbered}

### DOE/NNSA PCD {#doennsa-pcd .TextBold .unnumbered}

### Quality Assurance Program Plan {#quality-assurance-program-plan .TextBold .unnumbered}

# SECTION 1.0 {#section-1.0-1 .unnumbered}

# INTRODUCTION {#introduction .unnumbered}

1.1 []{#Appendix_G_Purpose .anchor}Purpose

The DOE/NNSA PCD is responsible for the Type B packaging certification
program, and for reviewing and recommending approvals or disapprovals of
requests for offsite transportation authorizations.

NRC regulations in 10 CFR 71, Subpart H, Quality Assurance, require that
users of Type B packaging have an approved quality assurance program
that meets Subpart H requirements. 10 CFR 830.120 and DOE Order 414.1A
require that DOE organizations/elements develop their QAPPs by applying
the quality assurance criteria using a graded approach. DOE Order 414.1A
also endorses the use of a single integrated quality assurance program
to satisfy the requirements for the regulated work, and any additional
quality requirements imposed by DOE elements, and the requirements of
DOE Order 414.1A.

1.2 []{#Appendix_G_Scope .anchor}Scope

This QAPP applies to the DOE/NNSA PCD's organization and programs. The
overall management systems for the administration and operation of this
organization are provided by DOE/NNSA and Service Center policies and
procedures developed to meet the requirements of this QAPP, applicable
DOE Orders, regulatory and industry documents, and good management
practices.

This program description contains the quality requirements necessary to
meet the requirements of 10 CFR 830.120, DOE Order 414.1A, and 10 CFR 71
Subpart H, Quality Assurance.

1.3 []{#Appendix_G_Graded_Approach .anchor}Graded Approach

This QAPP was developed on the premise that the degree of application of
the program is based on a graded approach to quality commensurate with
the identified risk associated with the failure of items, processes, or
services as related to the safety of employees or the public; protection
of the environment; and achievement of DOE/NNSA programmatic missions.
Management controls are applied consistent with consideration of risk
and cost associated with the activity.

1.4 []{#Appendix_G_Integrated_Safety_Management .anchor}Integrated
Safety Management (ISM) Relationship

The elements of this QAPP are intended to be fully consistent with and
supportive of DOE/NNSA Integrated Safety Management Program functions
and principles. This QAPP details the methodologies employed to do work
processes safely, securely, and in accordance with established
procedures.

# SECTION 2.0 {#section-2.0 .unnumbered}

# QUALITY ASSURANCE PROGRAM {#quality-assurance-program .unnumbered}

**2.1** []{#Appendix_G_Quality_Policy .anchor}**Quality Policy**

It is the policy of PCD to provide reliable quality-based products and
services in a cost-effective manner. The PCD is committed to meeting and
exceeding both internal and external customer's requirements and
expectations by focusing on problem prevention and providing quality
improvement in all of its products and services. This QAPP applies to
those services, projects, and activities that may have an impact upon
the accomplishment of the DOE/NNSA mission objectives, the safety of
personnel, and the protection of the public and the environment.

**2.2** []{#Appendix_G_QA_Program .anchor}**Program**

This document is responsive to, and meets the requirements of ,10 CFR
830.120 and DOE Order 414.1A. It focuses on quality improvement by using
management systems for planning, performing, controlling, and evaluating
work. This QAPP has been developed and implemented to address the
commitments contained in the requirements documents and will be
maintained as required.

This document is the basis of the PCD quality assurance program. This
program is based on a business strategy, philosophy, and commitment that
emphasizes the continuous improvement of DOE/NNSA PCD products,
services, and processes and actions that are intended to increase the
satisfaction of both its internal and external customers. The PCD does
this by empowering its staff through the use of teamwork among its
members and customers, and by establishing and ensuring the attainment
of well-defined, measurable goals that support the success and quality
of its products and services. The PCD management has the authority,
responsibility, and accountability for establishing/maintaining
management systems that are consistent with the requirements of this
document and that will ensure its continued successful implementation.

The PCD management is responsible for ensuring that the requirements of
the quality program are appropriately adopted in programs and procedures
and are communicated and understood by appropriate personnel.

**2.3** []{#Appendix_G_QA_Responsibilities .anchor}**Responsibilities**

**A.** Senior management is accountable and responsible for the
development, scope and successful implementation of the quality
assurance program through:

1\. Providing for the development of a PCD integrated quality program
that includes procedures for implementing the work.

2\. Disseminating philosophies and guidance that promote the
establishment and maintenance of a workplace in which quality
performance is paramount, goals are established, achievement is
monitored and measured, and personnel are empowered and rewarded for
mission success.

3\. Providing an integrated line and quality function that will
effectively implement the quality program and ensure that work is
performed in a safe and secure manner.

The DOE/NNSA Service Center management retains the primary
responsibility for the scope and implementation of the DOE/NNSA Package
Certification and Offsite Transportation Authorization Program including
quality assurance related activities. However, individuals associated
with the program are responsible for achieving quality in the activities
for which they are responsible.

Senior management is to ensure that adequate resources are provided to
accomplish these quality objectives.

**B.** Line management personnel are responsible for the implementation
of the quality program. They are accountable for the attainment of
quality and for conducting management assessments to ensure the
effectiveness of the quality program. Line management is also
responsible for identifying, monitoring, evaluating, and reporting
measured results of selected performance indicators and achieving
mission success.

**C.** The quality system establishes that employees are empowered to
achieve continuous quality improvement as they perform their daily and
routine tasks. Empowered employees identify and report problems in
quality so that problems may be evaluated and corrective actions be
initiated when necessary. Every employee has the right, obligation, and
authority to "stop work" IMMEDIATELY when any operation or activity
jeopardizes safety, security, health, the environment, has imminent
life-threatening implications, or creates a significant condition
adverse to quality. The employee notifies responsible management of the
discrepant conditions so that remedial action can be taken.

**D.** For certain activities, QA specialists may be matrixed to provide
support for an activity, including site observations and surveillance,
quality studies, and further support dictated by the project or
activity.

# SECTION 3.0 {#section-3.0-1 .unnumbered}

# PERSONNEL TRAINING AND QUALIFICATIONS {#personnel-training-and-qualifications .unnumbered}

3.1 []{#Appendix_G_TQ_Intro .anchor}Introduction

Both 10 CFR 71, Subpart H and 10 CFR 830.120 require that training
programs and procedures for safety packaging and transportation of
nuclear materials associated with DOE/NNSA Defense Programs be developed
and implemented. This training program should ensure that all DOE/NNSA
Service Center employees who support packaging certification and offsite
transportation authorization requests are trained and qualified to
perform their assigned work, and provide continuing training which
ensures that the employee's job proficiency is maintained. These
requirements may be satisfied through formal training, in-house
training, seminars, on-the-job training, or educational opportunities
available through outside organizations. The principal components of the
DOE/NNSA PCD training program are the CE TQS and Manager TQS, and the
associated Technical Qualification Cards.

3.2 []{#Appendix_G_TQ_Responsibilities .anchor}Responsibilities

**A.** Management (the individuals identified in Section 2,
"Responsibilities" of this guide) should ensure that DOE/NNSA PCD
personnel receive on-the-job training or classroom training sufficient
to enable them to perform their assigned tasks and meet the PCD CE and
Manager TQS and Technical Qualification Card requirements. This should
be accomplished through coordination with, and guidance from, the
DOE/NNSA Service Center's Training and Development Department.

**B.** Management should commit resources to facilitate the training
qualification processes, to establish qualification and training
requirements for personnel in their organizations, and to ensure that
personnel hired or transferred into positions meet the appropriate TQS
requirements.

**C.** Management should ensure that specifications are established for
each level of their organization which describe training and
qualification processes, including requirements, interfaces, training
methods, and the assignment of training responsibilities and duties.
These specifications should comply with the guidance provided by
DOE/NNSA Service Center's Training and Development Department.

**D.** Training records and written test scores should be maintained for
qualified packaging and transportation personnel.

3.3 []{#Appendix_G_TQ_Qualification_of_Personnel .anchor}Qualification
of Personnel

DOE/NNSA Service Center management is responsible for ensuring that a
packaging certification personnel qualification system continues to be
implemented and maintained. The purpose for evaluating experienced
packaging personnel currently supporting the packaging program and for
the subsequent qualification process is to ensure that the performance
levels of the individuals working in these programs are maintained at
high levels. Packaging certification personnel will be re-certified at
three-year intervals unless otherwise specified. Packaging certification
personnel who are assigned as TSRP Chairman are selected and qualified
on the basis of education, experience, and proficiency. 10 CFR 830.120,
paragraph 2.3 "Qualification of Personnel" states that "policies and
procedures that describe personnel selection requirements should be
established for each position." DOE Order 5480.20A, *Personnel
Selection, Qualification, and Training Requirements for Nuclear
Facilities,* addresses "selection, qualification, and training
requirements for...personnel involved in the operation, maintenance, and
technical support of DOE-owned...nuclear facilities." It also states the
following - "qualification is defined in terms of education, experience,
training, examination, and any special requirements necessary for
performance of assigned responsibilities."

**3.4** []{#Appendix_G_TQ_Training .anchor}**Training**

DOE/NNSA Service Center management is responsible for ensuring that the
packaging certification personnel associated with approving radioactive
material packages and authorizations for offsite shipments made in the
interest of national security and associated activities achieve and
maintain the qualifications they need to perform their assigned work. To
ensure that all identified training needs are fully met, training is
obtained from a variety of sources. Training for each individual is
obtained in accordance with an individual development plan or equivalent
document. The contents of each individual's development plan are the
result of consideration of a number of factors. These factors include
the individual's unique background, the formal training and
certification requirements established for a particular job and the
individual's developmental needs.

This information should be reviewed annually by the packaging management
and be updated as needed to provide more current, in-depth, and complete
training. Special attention should be paid to maintaining the
availability of training that will encourage workers to maintain and
enhance proficiency. Required re-training or refresher training will
also be identified and provided, as appropriate.

DOE/NNSA Service Center personnel who perform and/or control packaging
and offsite transportation tasks require special training. They are to
be qualified and certified as determined by the DOE/NNSA CE and Manager
TQS and Technical Qualification Card and Service Center management.
These special training needs should be documented in the individual's
development plan or equivalent documentation. The following suggested
training and the required training (shaded areas) are listed:

1.  Effective Public Presentations,

2.  Effective Letter Writing,

3.  Fundamentals for DOE Operations Course, NNSA Service Center

4.  Radiation Worker Safety SNL/NM

5.  [Hazardous Materials Transport 49 CFR (12 Modules), DOE]{.mark}

6.  Basic RAM Packaging DOE

7.  Advanced RAM Packaging DOE

8.  Social Styles, Wilson Learning,

9.  Authorized Derivative Classifier, NNSA Service Center

10. Methods of Probabilistic Risk Assessment, DOE/INEL

11. [Nuclear Weapons Systems Safety, LANL/LLNL/SNL]{.mark}

12. Nuclear Weapons Electrical Testers, SNL/NM

13. Nuclear Weapons Design Workshop for DOE SNL/NM

14. Containment Criteria for shipping containers LLNL

15. [Welding Criteria for Shipping Containers. LLNL]{.mark}

16. SARP Reviewers Workshop LLNL

17. Quality Assurance for RAM Packages, LLNL

18. [Design of Type B Packages Workshop, NNSA Service Center]{.mark}

19. [DOE Hoisting and Rigging, DOE/Hanford]{.mark}

20. Communications Skills, NNSA Service Center

21. [Criticality Safety, LANL/ORNL]{.mark}

22. [Explosive Firing Site and Laboratory Safety Course, NM/TECH]{.mark}

[]{.mark}

3.5 []{#Appendix_G_TQ_Reading_File .anchor}Reading File

Because training is an ongoing process, a reading file should be
established and maintained. Newly issued regulations, lessons learned
and other relevant materials concerning individual work assignments
should be distributed and/or readily available (electronic files/Web
Pages), and their mandatory reading should be discussed in open forums
and documented. This is required for DOE employees certified to the
Personnel Security Program (PSP) and should be applied as appropriate to
non-PSP staff.

3.6 []{#Appendix_G_TQ_Records .anchor}Records

10 CFR 830.120 and 10 CFR 71, Subpart H require that records that
reflect the results of training and qualification activities are
maintained. These records should be compiled into a records management
system that ensures the records are auditable.

DOE/NNSA Service Center training should be documented in accordance with
Section 4.0 of this Appendix and according to the DOE/NNSA Training
Coordinator protocols.

Objective documentation of personnel job proficiency, both satisfactory
and unsatisfactory, should be maintained for the duration of the project
or activity affected, or longer if required by statute.

**SECTION 4.0**

# PROGRAM IMPROVEMENT {#program-improvement .unnumbered}

4.1 []{#Appendix_G_Program_Improvement_Intro .anchor}Introduction

As stated in DOE G 414.1-2, *Quality Assurance Management System Guide,*
an effective planned and implemented quality assurance management system
is one that:

**A.** Uses feedback information to improve items, services, and the
processes that produce them.

**B.** Prevents or minimizes quality problems.

**C.** When necessary, corrects problems that occur.

DOE/NNSA PCD programs and procedures provide systems for continually
pursuing quality improvement by reducing the variability of activity
results and through promotion of problem prevention, identification, and
correction. The PCD has established and implemented systems to detect
and prevent quality problems. It emphasizes problem prevention, problem
correction, and continuous improvement. This strategy consists of these
elements: worker involvement, goal setting, measurement, feedback, and
teamwork.

A no-fault environment is promoted in which all personnel have the
freedom (and are expected) to identify potential problems and
nonconformances and recommend improvements without fear of reprisal.

**4.2** []{#Appendix_G_Program_Improvement_Activity
.anchor}**Activities**

Work product should be checked to ensure conformance with the approved
management system controlling that work activity. Services and products
that do not meet established requirements are identified, controlled,
and corrected according to the importance of the problem and the work
affected. Personnel that are responsible for analyzing and
dispositioning non-compliances are required to have an adequate
technical understanding of the noncompliance and have access to
pertinent information associated with the noncompliance. Included within
the management control system is the corrective action planning,
tracking, validating, verifying, and closing of issues. Root cause
analyses are performed in accordance with procedures, to identify basic
causal factors to prevent recurrence of the problem.

# SECTION 5.0 {#section-5.0 .unnumbered}

# DOCUMENTATION AND RECORDS {#documentation-and-records .unnumbered}

5.1 []{#Appendix_G_Documentation_Records_Intro .anchor}Introduction

In accordance with 10 CFR 830.120, 10 CFR 71, Subpart H and DOE Order
414.1A requirements, a proceduralized document control and records
management system is required to support the DOE/NNSA Package
Certification and Offsite Transportation Authorization Program and other
nuclear weapons program functions. Such a system should establish and
maintain sufficient written records that describe the Defense Programs
activities in a cost-effective manner and are consistent with the
applicable regulations.

Features of the system include limiting access by unauthorized persons;
providing protection from misuse or natural disasters; ensuring
efficient document issuance, distribution, record storage, retention,
and prompt retrieval; as well as providing preservation, or disposition
of records according to schedules modeled after the National Archives
and Records Administration (NARA) Guide and General Records Schedule
(GRS) directives. Retention of records is specified for three years
beyond the date when the activity was last performed. Superseded
procedures or instructions must be retained for three years after the
superseding material is issued.

**NOTE:** A **document** is any recorded information that specifies,
describes, defines, reports, or certifies activities, requirements,
procedures, or results. Documents include plans for important activities
to be accomplished. A document is a working instrument that may be
revised and reissued as needed before being declared a quality record. A
document is not considered a record until it meets the definition of a
record (10 CFR 830.3(a)). A **record** contains information that is
retained for its expected future value. Records should be sufficient to
support technical and regulatory decisions. Records may be in a variety
of forms (e.g., electronic, written or printed, microfilm, photographs,
radiographs, optical disks, and etc.).

5.2 []{#Appendix_G_Documents .anchor}Documents

Documents are required by DOE/NNSA to control policy and administrative
and/or technical information. A document may describe work to be done,
data to be used at different locations or by different people, or, in
changing situations, data to be controlled from time to time for
reference purposes. Documents that will not become records may be
managed at the discretion of the responsible manager or supervisor.
Documents should be controlled in accordance with written and approved
procedures and instructions. Procedures and instructions must ensure
that documents, including changes, are reviewed for adequacy and
approved for release.

### A. DOE/NNSA PCD Documents {#a.-doennsa-pcd-documents .TextBold .unnumbered}

1\. OTC/OTA Documents

The PCD Manager should maintain a master packaging records file for each
packaging OTC and OTA. The master files should include but not be
limited to the following documents:

a\. Final packaging SARP or TSRA as appropriate and any subsequent
amendment or revisions of the document or the OTC/OTA.

b\. The request for the new packaging.

c\. The packaging production specifications and design drawing package
including special fixtures inside the packaging and/or the shipment
vehicle.

d\. Packaging specifications for active packaging procurements.

e\. Results of any subsequent reviews of amendments or revisions to
SARPs, TSRAs, and packaging or transportation related criteria.

f\. Updated list of users for specific packaging and their authorization
for use.

g\. Maintenance, safety, and quality assurance records, including the
contractor's QAPP.

h\. Modifications to the package including requests to DOE/NNSA for
Quality Category design changes.

i\. Safety Evaluation Report.

j\. Other pertinent information, i.e., loading, unloading, tie-down,
vehicle complication documentation, etc.

k\. Documentation of re-certification or stop use.

### B. Procedures {#b.-procedures .TextBold .unnumbered}

1.  Approved procedures and instructions should be issued through an
    approved document control process.

2.  Revisions to procedures and instructions should be controlled by the
    same process used to review and approve the original procedures or
    instructions.

3.  Special process procedures and instructions concerning
    non-standardized, non-routine work tasks that are expected to be
    performed once or rarely should be documented in accordance with
    applicable codes or standards.

4.  Procedures should address the following considerations for the
    control and guidance of work activities:

a\. Acceptance criteria.

b\. Conditions and requirements as defined by the applicable
specifications, codes, or standards.

c\. Qualification and certification requirements for procedures,
specifications, and personnel.

d\. Equipment or calibration requirements.

e\. Parameters for which verification and/or documentation is required.

5.  Procedures and/or instructions should be prepared for each
    quality-affecting activity to the level of detail necessary to
    assure that the activity can be performed as required. Procedures
    and/or instructions should include or refer to appropriate
    quantitative or qualitative acceptance criteria for determining that
    prescribed activities have been completed as specified. Procedures
    and/or instructions should be uniquely identifiable, retrievable,
    and reproducible.

6.  Procedures should include, but not be limited to, the following
    stipulations:

a\. Approval signatures and effective date.

b\. Unique identifier, including revision number.

c\. Purpose: a short statement of the objective of the procedure or
instruction and what it contains.

d\. Applicability or scope: a concise description of the requirements
and to which organization they apply.

e\. References: identification of the source of requirements.

f\. Definitions: descriptions of unique acronyms or unique terms.
Definitions should be based on standards, codes, regulations, DOE
orders, etc.

g\. Procedure: description of the actions necessary to accomplish the
objectives identified in the purpose statement.

h\. Records: identification of records produced or retained by
compliance with the procedure.

### 5.3 Records Maintenance Measures  {#records-maintenance-measures .TextBold .unnumbered}

(See G-830.120, Para. 4 reference to the NARA and GRS regulations, 10
CFR 830.120(c)(1)(iv), and 10 CFR 71.135)

**A.** At a minimum, these measures should include, but not be limited
to, the following:

1.  Ensuring that records are legible, complete, and authenticated as
    the record copy before acceptance.

2.  Identifying and marking (indexing) records, including records
    released for review.

3.  Creating a records index to facilitate retrievability. It should
    include the record type, unique identifier, record retention time,
    criteria for disposition, and location of the record within the
    record system.

4.  Acknowledging receipt of record transmittals.

5.  Archiving according to the model of the NARA GRS, and in a manner
    that protects records from detrimental environmental effects.

### B. Quality Assurance Records  {#b.-quality-assurance-records .TextBold .unnumbered}

(See 10 CFR 830.120(c)(1)(iv), G-830.120, Para. 4, with reference to the
NARA and GRS regulations; and 10 CFR 71.113)

Sufficient records should be prepared and maintained as work is
performed to furnish documentary evidence of the quality of items and of
activities affecting quality. The following elements should be included
in the contractor's records system

1.  Records should be consistent with applicable codes, standards,
    specifications, and contracts and should be adequate for use in
    management of the Package Certification and Offsite Transportation
    Authorization Program and other nuclear weapons safety programs.

2.  Records should include the instructions, procedures, and drawings
    that prescribe quality assurance activities (when completed or
    superseded), results of reviews, inspections, tests, audits,
    monitoring of work performance, materials analyses, and facility
    operating logs.

3.  Records should include, as appropriate, closely related data such as
    qualifications of personnel, procedures, and equipment and other
    documentation required by the applicable parts of this Guide.

4.  Inspection and test records should, at a minimum, identify the date
    of inspection or test; the inspector or data recorder; the type of
    observation, the results, the acceptability, and the action taken in
    connection with any deficiencies noted.

5.  Required records should be legible, identifiable, and retrievable.

6.  Requirements and responsibilities for record transmittal, retention,
    and maintenance subsequent to completion of work should be
    established and documented consistent with applicable codes,
    standards, and procurement documents.

7.  Records that correctly identify the as*-*built conditions of
    packages, packaging, and other designated materials should be
    maintained for at least the life of the item, while the item is
    stored for future use or while it is in use. Retention times for all
    records should be specified. These records should include:

    a.  Material certification and test data for traceability and
        quality verification.

    b.  Reports of inspections, examinations, and test results for
        conformance verification.

    ```{=html}
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    ```
    a.  Drawings, specifications, procedures, and instructions for use
        in control of configuration.

d\. Records of nonconformances and their resolution.

### C. Changes to Records {#c.-changes-to-records .TextBold .unnumbered}

Changes to records should be reviewed and approved by the same
organizations that performed the original review and approval unless
other organizations are specifically designated by an individual with
the authority to do so. The reviewing organization should have access to
pertinent background information upon which to base its approval, and
should have adequate understanding of the requirements and intent of the
original record. The changes should include the date and the
identification of the person authorized to issue such changes.

# SECTION 6.0 {#section-6.0 .unnumbered}

# WORK PROCESSES {#work-processes .unnumbered}

6.1 []{#Appendix_G_Work_Processes_Intro .anchor}Introduction

This section provides general requirements and guidance for the
establishment and execution of the DOE/NNSA PCD responsibilities for the
design, fabrication, and use of packaging for the transportation of
materials of national security interest. Some activities included are:
designing, modifying, fabricating, assembling, installing, inspecting,
testing and evaluation, procuring, handling, shipping, documenting,
independent review, operating, maintaining, repairing, and application
of Quality Assurance requirements identified in DOE Order 414.1A.

6.2 []{#Appendix_G_Work_Processes_Mgt_Responsibi .anchor}Management
Responsibility

### A. Conduct of Work {#a.-conduct-of-work .TextBold .unnumbered}

DOE/NNSA Service Center management promotes the ISM concept that quality
and safety are part of the work process. Employees are properly trained
and are knowledgeable in the procedures, instructions, drawings,
specifications, and other related administrative and technical documents
that control the work. Work processes are conducted according to the
applicable requirements established in DOE/NNSA management requirements'
documents, including flow down procedures and instructions, which are
prepared for the conduct of work activities. Work is then undertaken in
accordance with DOE standards, procedures, and instructions.

1.  Work should be performed to established technical standards and
    administrative controls.

2.  Work should be performed under controlled conditions using approved
    instructions, procedures or other appropriate means.

3.  Work should be performed in accordance with an established and
    executed QAPP consistent with DOE Order 461.1A for the activities
    cited in Section 5.1 above.

### Identification and Control of Items {#identification-and-control-of-items-1 .TextBold}

The PCD is not directly involved in the identification and control of
items. Refer to Section 3 of this guide for information and control of
items guidance that PCD provides to the users of its products and
services.

### Handling, Storing, and Shipping {#handling-storing-and-shipping-1 .TextBold}

The PCD is not directly involved in handling, storing and shipping.
Refer to Section 3 of this guide for handling, storing and shipping
guidance that PCD provides to the users of its products and services.

### D. Control of Engineered Items  {#d.-control-of-engineered-items .TextBold .unnumbered}

The PCD is not directly involved in the control of engineered items.
Refer to Section 3 of this guide for guidance on control of engineered
items that PCD provides to the users of its products and services.

### E. Control of Commercially Procured Items  {#e.-control-of-commercially-procured-items .TextBold .unnumbered}

The PCD is not directly involved in the control of commercially procured
items. Refer to Section 3 of this guide for control of commercially
procured items guidance that PCD provides to the users of its products
and services.

### F. As Low As Reasonably Achievable  {#f.-as-low-as-reasonably-achievable .TextBold .unnumbered}

DOE/NNSA management should ensure that procedures and practices are
developed and used to ensure that personnel exposure to radiation is
maintained *as low as reasonably achievable* as required in 10 CFR 835.

### G. Computer Software Control  {#g.-computer-software-control .TextBold .unnumbered}

DOE/NNSA PCD does not procure software used in support
operations/activities under its cognizance. Refer to Section 3 of this
guide for guidance on computer software control for organizations that
provide technical computer based support to PCD.

# SECTION 7.0 {#section-7.0 .unnumbered}

# DESIGN CONTROL {#design-control .unnumbered}

DOE/NNSA PCD does not design any of the hardware or equipment used in
the DOE/NNSA Defense Programs packaging program. However, PCD does
oversee and enforce design control requirements for the DOE/NNSA
certified packages through the package certification process. Refer to
Section 3 of this Safety Guide for additional information.

# SECTION 8.0 {#section-8.0 .unnumbered}

# PROCUREMENT  {#procurement .unnumbered}

DOE/NNSA PCD will comply with the DOE prescribed procurement process by
ensuring that tasks for technical support services comply with specified
SOW requirements. Quality assurance representatives that perform vendor
surveillances in support of the DOE/NNSA package certification program
will follow acceptable ASME NQA-1, engineering assessments requirements.

# SECTION 9.0 {#section-9.0 .unnumbered}

# INSPECTION AND ACCEPTANCE TESTING  {#inspection-and-acceptance-testing .unnumbered}

Inspection and acceptance testing of specified items (i.e., packagings,
transport vehicles, aircraft, and prime movers) and processes should be
conducted using established written acceptance and performance criteria.
Equipment used for inspections and tests should be calibrated and
maintained. This criterion is typically not directly applicable to PCD
functions and activities as its contractors have the lead responsibility
for these functions as dictated by the individual SARPs for each
approved packaging.

# SECTION 10.0 {#section-10.0 .unnumbered}

# APPRAISALS  {#appraisals .unnumbered}

DOE Order 461.1A assigns DOE/NNSA Headquarters the responsibility for
maintaining a comprehensive system of planning, conducting and
documenting appraisals of DOE/NNSA contractors, National Laboratories,
and Site Offices. PCD supplies members for the DOE/NNSA Headquarters
appraisal teams, as requested.

# SECTION 11.0 {#section-11.0 .unnumbered}

# DOE/NNSA PCD INDEPENDENT SURVEILLANCES  {#doennsa-pcd-independent-surveillances .unnumbered}

A surveillance system for oversight and/or analyses of packaging and
transportation processes is maintained and used by the DOE/NNSA to
assist its customers in establishing and maintaining programs and
processes that conform to the federal regulatory and DOE Order
requirements and promote continuous improvements.

The focus and emphasis of the surveillance may differ depending on the
reason(s) for conducting the surveillance. Regulatory compliance is the
baseline for any surveillance conducted by DOE. DOE/NNSA PCD performed
independent surveillances, in addition to reviewing the organization's
compliance with regulatory and DOE Order requirements, focus on
identifying areas for program improvement. Management surveillances
focus on management issues of the entire program and how well the
organizations are working together rather than just compliance issues.

The PCD Manager should:

**A.** Define the scope of each surveillance activity, with the help of
the CEs, prior to tasking a team to perform the surveillance; and,

**B.** Ensure that the surveillance team member(s) are sufficiently
independent from the subject organization to objectively perform the
assigned surveillance (e.g., personnel selected to perform surveillance
activities should not have direct responsibilities in the area they are
assessing).

Refer to Appendix D of this guide for additional information on PCD
performed surveillances.

###  {#section-107 .TextBold .unnumbered}

###  {#section-108 .TextBold .unnumbered}

###  {#section-109 .TextBold .unnumbered}

###  {#section-110 .TextBold .unnumbered}

###  {#section-111 .TextBold .unnumbered}

###  {#section-112 .TextBold .unnumbered}

###  {#section-113 .TextBold .unnumbered}

###  {#section-114 .TextBold .unnumbered}

###  {#section-115 .TextBold .unnumbered}

###  {#section-116 .TextBold .unnumbered}

###  {#section-117 .TextBold .unnumbered}

###  {#section-118 .TextBold .unnumbered}

### Appendix H {#appendix-h .TextBold .unnumbered}

###  {#section-119 .TextBold .unnumbered}

### Acronyms and Definitions {#acronyms-and-definitions .TextBold .unnumbered}

H-1

# ACRONYMS AND DEFINITIONS {#acronyms-and-definitions-1 .unnumbered}

AL Albuquerque

ALARA As Low as Reasonably Achievable

ANSI American National Standard Institute, Incorporated

Applicant A DOE Element that requests DOE/NNSA approval to use certified
(OTC) or authorized (OTA) packaging.

Appraisal A planned and documented investigative evaluation of an item
or process to determine the adequacy and effectiveness as well as
compliance with established procedures, instructions, drawings, Quality
Assurance Program Plans (QAPPs), and/or other applicable documents.

ASME American Society of Mechanical Engineers

ASTM American Society for Testing and Materials

Authorized User A DOE or NNSA contractor that is listed as an Authorized
user on the PCD Package Certification and Offsite Authorization WEB
Site. To obtain the status of Authorized User, the shipper and receiver
must have a copy of the applicable current SARP, SER and OTC and/or OTA,
PCD approved packaging procedures, and a QAPP approved by the site's
federal management. Similar requirements are required for proposed TSS
shipments made under a CofC or CofCA.

BPVC Boiler and Pressure Vessel Code

CE Certification Engineer

Certified or Certification Refers to a written statement signed and
dated by a qualified person that confirms a standard of performance as
true, accurate or genuine.

CFR Code of Federal Regulations

CofC Certificate of Compliance

CofCA Certificate of Competent Authority

Consignee Package receiver

Consignor Package shipper

H-2

Corrective Action Action(s) to correct an identified nonconformance such
that, at the completion of the action, the nonconformance no longer
exists.

Customer The DOE/contractor who is the package user (e.g., design
agency, or Department of Defense).

Design Owner The DOE/NNSA contractor that is responsible for the Type B
Packaging's design specifications, packaging's design and configuration
control, packaging's performance testing and evaluation, packaging's
material selection and fabrication, packages acceptance and maintenance
procedures, and maintenance of the official records for those
responsibilities.

Design Specifications The specific regulatory requirements, national
standards, performance characteristics and operational needs that will
ensure that the radioactive material packages shipped in the TSS comply
with DOE Orders and regulatory requirements.

Document Recorded information that describes, specifies, reports,
certifies, requires, or provides data or results. A document is not
considered a record until it meets the definition of a record. (10 CFR
830.3(a).)

DoD Department of Defense

DOE Department of Energy

DOT Department of Transportation

Electronic Record Any information that is recorded in a form that only a
computer can process and that satisfies the definition of a record. (41
CFR 201-45.201.)

FEA Finite Element Analysis

Fissile Material plutonium-239, plutonium-241, uranium-233, uranium-235,
or any combination of these radionuclides.

FTU Flight Test Unit

GRS General Record Schedule

HAC Hypothetical Accident Conditions

HAR Hazards Analysis Report

H-3

Hazardous Components Those parts of nuclear explosives or special
assemblies that contain hazardous (other than radioactive) materials, as
defined in 49 CFR.

HAZMAT Hazardous Materials

HE High Explosives

IAEA International Atomic Energy Agency

INEEL Idaho National Engineering and Environmental Laboratory

ISM Integrated Safety Management

JTA Joint Test Assembly

LANL Los Alamos National Laboratory

LLNL Lawrence Livermore National Laboratory

LTU Laboratory Test Unit

Major Design Change Any change to a Quality Category A or B container
component

Minor Design Change Any change to a Quality Category C container
component

MCNP code Monte Carlo Neutral Particle code

NARA National Archives and Records Administration

NCT Normal Conditions of Transport

NELA Nuclear Explosive-Like Assembly, a nuclear weapon program special
assembly that meets the definition specified in the *Nuclear
Explosive-Like Assembly Requirements* section of DOE Order 452.2B.

NM New Mexico

NM/TEC New Mexico Institute of Mining and Technology

NNSA National Nuclear Security Administration

Nonconformance A deficiency in design requirements, characteristics,
documentation, or procedures which renders the quality of an item or
activity unacceptable or indeterminate. Examples of nonconformance
include: out of design tolerance, physical defects, test failures,
incorrect or inadequate documentation, and deviation from prescribed
procedures.

H-4

NRC Nuclear Regulatory Commission

Nuclear Components Those parts of nuclear explosives or special
assemblies that contain fissile and/or radioactive and other materials.

ORNL Oak Ridge National Laboratory

OTA Offsite Transportation Authorization, a DOE/NNSA document , approved
and issued by the DOE/NNSA Certifying Official, that authorizes a
nuclear weapons-related shipping campaign on a limited basis (i.e., for
a specific package and loading configuration, designated routes, and
campaign duration).

OTC Offsite Transportation Certificate, a DOE/NNSA document , approved
and issued by the DOE/NNSA Certifying Official, that authorizes
(certifies) a specific package (packaging and specified content) for
DOE/NNSA radioactive material transportation activities for use on a
one-time basis or for up to 5 years.

OST Office of Secure Transportation

Package The packaging together with its contents as presented for
transport.

Packaging The assembly of components necessary to comply with the
packaging requirements of Title 49 CFR, e.g., marking, labeling, tamper
indicator device (TID) sea, radiological surveys, and records. It may
consist of one or more receptacles, absorbent materials, spacing
structures, thermal insulation, radiation shielding, and devices for
cooling or absorbing mechanical shocks.

PRA Probabilistic Risk Assessment

PSP Personnel Security Program

PCD Packaging Certification Division

QA Quality Assurance

H-5

QAPP Quality Assurance Program Plan. A record which cites the overall
criteria, including policies, to be met by the Nuclear Explosive and
Weapon Safety Program; defines the staff authority and responsibility;
explains how the program functions to accomplish criteria requirements;
explains how procedure activities are related to one another; and
provides for the performance and appraisal of work.

QC Quality Control

Qs Comments/questions developed during the review of a SARP/TSRA/HAR.

Qualified or Qualification Refers to a person's ability or skill that
satisfies a condition or standard to which compliance is required for
the performance of a specified activity.

Quality Assurance Refers to those process or product features which meet
customer requirements, and thereby provide process or product
satisfaction; and/or freedom from deficiencies in a process or product.

Radioactive Material Any material having a specific activity greater
than 0.002 microcuries per gram.

RAM Radioactive Material

Record 1) A completed document or other medium which provides objective
evidence of an item, service, or process. (10 CFR 830.3(a).)

2\) "\...all books, papers, maps, photographs, photo-negatives, machine
readable materials, or other documentary materials, regardless of
physical form or characteristics, made or received by an agency of the
United States Government under federal law or in connection with the
transaction of public business and preserved or appropriate for
preservation by that agency or its legitimate successor as evidence of
the organization, functions, policies, decisions, procedures,
operations, other activities of the Government or because of the
informational value of data in them." (44 USC 33010 and DOE G 1324.5B
*Guide for DOE1324.5B Records Management*)

H-6

Risk The combination of the probability of an incident releasing
radioactive and/or hazardous materials, and the consequences of the
release on the public and the environment, which when taken over all
events relating to system operation provide a meaningful picture of the
adverse impact.

SA Special Assembly, a major assembly that may contain nuclear
components and/or hazardous components, or no hazardous or nuclear
components but still meet the definition of a NELA (See *Nuclear
Explosive-Like Assembly Requirements* section of DOE Order 452.2B) that
does not compose a complete nuclear explosive and is not capable of
producing a nuclear detonation. Special assemblies include, joint test
assemblies, flight test units, laboratory test units and trainers.

SARP Safety Analysis Report for Packaging, a document that provides a
comprehensive technical evaluation of packaging. The SARP consists of
sections on general information; structural, thermal, containment,
shielding testing, analysis and evaluations; operating procedures;
acceptance tests, and maintenance and quality assurance programs. The
purpose of the SARP is to demonstrate compliance with the applicable
sections of 10 CFR 71 and 49 CFR 100-185. DOE/NNSA uses the approved
SARPs as the safety basis certifying Type B packages and issuing OTCs.

H-7

SER Safety Evaluation Report, a document that provides

> final results of the PCD TSRP's safety evaluation, including its
> independent review of the SARP and/or TSRA and/or HAR. More
> specifically, the SER serves the following functions: provides a
> description of the package design, if applicable; documents the
> results of the SARP and/or TSRA review and confirmatory analysis, or
> the results of the analysis of the HAR; confirms that the methodology,
> assumptions, and technical data used are in compliance with safety
> standards and regulations; identifies packaging design deficiencies or
> SARP/TSRA and how they were resolved; documents restrictions on the
> use of the packaging/shipment that will be repeated in the OTC/OTA;
> and provides the basis for recommending approval or disapproval of the
> OTA/OTC.

SG Safety Guide

SGT Safeguards Transporter

SNL Sandia National Laboratories

SNL/NM Sandia National Laboratories/New Mexico

SME Subject Matter Expert, an individual who has achieved a senior level
status in his or her profession according to the criteria established by
the profession, and/or documented knowledge and years of experience.

SNM Special Nuclear Material

SR Supplemental Report

SSC Structures, Systems, Components

SST Safe-Secure Trailer

Surveillance The act of monitoring or observing to verify whether an
item or activity conforms to specified requirements. (ASME NQA-1-1994.)

TQS Technical Qualification Standard

H-8

TSRA Transportation System Risk Assessment, a formal documentation that
records the hazards, the assessment of the hazards, the analysis
method(s), and actual analysis and results used to determine the
probability and consequences of undesired but credible events that could
pose risks to the workers, public and/or the environment during the
proposed offsite transportation of an uncertified package or a special
assembly that contains a Type B quantity of radioactive material in a
prescribed transportation system and routes.

TSRP Transportation Safety Review Panel, a committee, chaired by a
Federal employee and composed of persons with appropriate expertise,
that performs technical reviews to verify compliance with DOE Order
461.1A and makes recommendations for package certifications and offsite
transportation authorizations.

TSS Transportation Safeguards System

Type A package A packaging that, together with its radioactive contents
limited to A~1~ or A~2~ as appropriate, meets the requirements of 49 CFR
173.410 and 49 CFR 173.412 and is designed to retain the integrity of
containment and shielding required by 49 CFR 173 under normal conditions
of transport as demonstrated by the tests set forth in 49 CFR 173.465
and 49 CFR 173.466, as appropriate. A Type A package does not require a
Competent Authority Approval.

Type AF package A Type A package that is qualified for packaging and
shipping a Type A quantity of fissile material.

Type B package A Type B packaging that, together with its radioactive
content, is designed to retain the integrity of containment and
shielding required by 49 CFR 173 when subjected to the normal conditions
of transport and hypothetical accident test conditions set forth in 10
CFR 71.

H-9

Verification The act of reviewing, inspecting, testing, checking,
conducting surveillances, auditing, or otherwise determining whether
items, processes, or services meet specified requirements. The terms
*appraisal* and *verification*, as used in DOE Order 5700.6C and 10 CFR
830.120, are synonymous; their use is determined by who is performing
the work. Appraisals are performed by, or for senior management.
Verifications are performed by the line organization.

H-10

###  {#section-120 .TextBold .unnumbered}

###  {#section-121 .TextBold .unnumbered}

###  {#section-122 .TextBold .unnumbered}

###  {#section-123 .TextBold .unnumbered}

###  {#section-124 .TextBold .unnumbered}

###  {#section-125 .TextBold .unnumbered}

###  {#section-126 .TextBold .unnumbered}

###  {#section-127 .TextBold .unnumbered}

###  {#section-128 .TextBold .unnumbered}

### Appendix I {#appendix-i .TextBold .unnumbered}

###  {#section-129 .TextBold .unnumbered}

### References {#references .TextBold .unnumbered}

I-1

# REFERENCES {#references-1 .unnumbered}

1.  American Society of Mechanical Engineers, *Quality Assurance
    Requirements for Nuclear Facility Applications*, ASME NQA-1-2000.

    1.  DOE/NNSA, *Design Guide for Packaging and Offsite Transportation
        of Nuclear Components, Special Assemblies, and Radioactive
        Materials Associated with the Nuclear Explosives and Weapons
        Safety Program*, SG 100.

    2.  DOE/NNSA *Design Guide for Testing Type B Packaging*, SG 600.

    3.  DOE/NNSA, *SARP Completeness Review Checklist for DOE/NNSA
        Defense Programs Packages*, SG 200.

    4.  DOE/AL Safety Guide 140.1, *Combined Test/Analysis Method Used
        to Demonstrate Compliance to DOE Type B Packaging Thermal Test
        Requirements (30 Minute Fire Test)*.

    5.  *DOE Radiation Protection Manual*, DOE/EH-0256T.

    6.  DOE Guide 414.1-2, *Quality Assurance Management System Guide
        for use with 10 CFR Part 830.120 and DOE O 414.1*, 06/17/99.

    7.  *DOE/NNSA Qualification Card, NNSA Package Certification
        Engineer, NNSA Service Center*.

    8.  *DOE/NNSA Qualification Standard, NNSA Package Certification
        Engineer, NNSA Service Center*.

    9.  *DOE/NNSA Qualification Card, Division Manager, Packaging
        Certification Division, NNSA Service Center*.

    10. *DOE/NNSA Division Manager, Packaging Certification Division,
        NNSA Service Center*.

    11. DOE Order 151.1A, *Comprehensive Emergency Management System*,
        November 1, 2000.

    12. DOE Order 231.1, *Environment, Safety, and Health Reporting*,
        Change 2, November 7, 1996.

    13. DOE Order 232.1A, *Occurrence Reporting and Processing of
        Operations Information*, August 1, 1997.

    14. DOE Order 420.1A, *Facility Safety*, 5/20/02.

    15. DOE Order 440.1A, *Worker Protection Management for DOE Federal
        and Contractor Employees*, 3/27/98.

    16. DOE Order 5480.19, *Conduct of Operations Requirements for DOE
        Facilities*, Change 2, October 23, 2001.

    17. DOE Order 461.1A, *Packaging and Transfer or Transportation of
        Materials of National Security Interest*, Publication of this
        revision is expected to be sometime in the near future.

    18. DOE Order 452.2B, *Safety of Nuclear Explosive Operations*,
        8/07/2001.

    19. DOE Manual M 461.1-1, *Packaging and Transfer of Materials of
        National Security Interest*, 9/29/00.

    20. DOE Order 414.1A, *Quality Assurance*, Change 1, July 12, 2001.

I-2

21. DOE Standard, *Preparation Guide for U.S. Department of Energy
    Nonreactor Nuclear Facility Safety Analyses*, DOE-STD-3009-94, July
    1994, Change Notice No. 2, April 2002.

22. DOE Standard, *Review and Approval of Nuclear Facility Safety Basis
    Documents (Documented Safety Analysis and Technical Safety
    Requirements),* DOE STD 1104-96, February 1996, Change 1 May 2002.

23. National Archives and Records Administration (NARA), Office of
    Records Administration, Records Administration Information Center,
    Agency Services Division (NIA), *General Records Schedules*, 1988
    ed., Washington, DC 20408. NOTE: These schedules provide a listing
    of record files common to several or all agencies of the federal
    government, and they include the corresponding disposition standard
    for each file.

24. Nuclear Regulatory Commission, *Standard Format and Content of Part
    71 Applications for Approval of Packaging for Radioactive
    Materials*, Proposed Revision 2, Regulatory Guide 7.9, May 1986.

25. Nuclear Regulatory Commission, *Standard Review Plan for
    Transportation Packages for Radioactive Materials*, NUREG-1609,
    March 31, 1999.

26. Technical Manual, *TIEDOWN PROCEDURES FOR TYPE-B CONTAINERS Shipped
    in Safe-Secure Trailer/Safeguards Transporter (SST/SGT)*.

27. Technical Manual, *DOE/TSD AIRCRAFT CARGO TIEDOWN MANUAL*.

28. Title 10 CFR, Energy, Part 71, *Packaging and Transportation of
    Radioactive Material*, and Subpart H, *Quality Assurance*.

29. Title 10 CFR, Energy, Part 830, *Nuclear Safety Management*.

30. Title 10 CFR, Energy, Part 830.120, *Quality Assurance*.

31. Title 10 CFR, Energy, Part 835, *Occupational Radiation Protection*.

32. Title 29 CFR, Labor, Part 1910, *Occupational Safety and Health
    Administration*.

33. Title 49 CFR, Transportation, Part 171, *Hazardous Materials
    Regulation*.

34. Title 49 CFR, Transportation, Part 172, *Hazardous Materials Table,
    Special Provisions, Hazardous Materials Communications, Emergency
    Response Information, and Training Requirements*.

35. Title 49 CFR, Transportation, Part 173, *Shippers--General
    Requirements for Shipments and Packagings*.

36. Title 49 CFR, Transportation, Part 175, *Carriage by Aircraft*.

37. Title 49 CFR, Transportation, Part 177, *Carriage by Public
    Highway*.

38. Title 49 CFR, Transportation, Part 397, *Transportation of Hazardous
    Materials; Driving and Parking Rules*.

39. Title 49 USC 1809(b), *Hazardous Materials Transportation Uniform
    Safety Act*, November 1990.

40. *Transportation of Nuclear Weapons Materiel*, Technical Publication
    TP 45-51.

41. Sandia Specification, *Reservoir Qualification AL-SX (H1616)* (U),
    SS393217.

42. *Shipping Configuration Index, H1616 Container* (U), SC395685.

43. *Regulatory Guide 7.8, Load Combinations for the Structural Analysis
    of Shipping Casks for Radioactive Material, Revision 1* dated March
    1989*.*

I-3

44. Nuclear Regulatory Commission, *Recommended Welding Criteria For Use
    in the Fabrication of Shipping Containers for Radioactive
    Materials*, NUREG/CR-3019, dated March 1984.

45. Nuclear Regulatory Commission, *Fabrication Criteria for Shipping
    Containers*, NUREG/CR-3854, dated March 1985.

46. Nuclear Regulatory Commission, *Guide for Preparing Operating
    procedures for Shipping Packages*, NUREG/CR-4775, dated December
    1998**.**

47. Nuclear Regulatory Commission, *Design Criteria for the Structural
    Analysis of Shipping Casks Containment Vessels*, Regulatory Guide
    7.6, dated March 1978**.**

48. Nuclear Regulatory Commission, *Fracture Toughness Criteria for Ease
    Material for Ferritic Steel Shipping Cask Containment Vessels with a
    Maximum Wall Thickness of 4 Inches (0.1 m)*, Regulatory *Guide
    7.11*, dated June 1991**.**

[]{#foreword .anchor}I-4