D-_10_(14_of_18)_N3B-AP-ER-0001,_r.0_Document_Development_for_Environmental_Deliverables.pdf

N3B-AP-ER-0001, R0

Document Development for Environmental Deliverables

Effective Date: 2/13/19

Next Review Date: 2/13/22

Hazard Class: Low Moderate High/Complex Usage Mode: Reference UET Both UET & Reference

The Responsible Manager has determined that the following organizations’ review is required for initial procedure release as well as subsequent major revisions. Review documentation is contained in the Document History File.

RCRA Remediation, Regulatory Documentation Group RCRA Remediation, Remediation Science and Engineering Regulatory and Stakeholder Interface, Regulatory Compliance Quality Assurance

Classification Review: Unclassified UCNI Classified

Tracy Drake /140891 / Signature on File / 1/28/19 Name (print) Z# Signature Date

Responsible Manager

Pamela Maestas /112829 / Signature on File / 2/5/19 Name (print) Z# Signature Date

Working Copy / Information Only (circle one) Initials / Date: /

RFP-0000300

Document Development Document No.: N3B-AP-ER-0001 for Environmental Deliverables Revision: 0 Effective Date: 2/13/19 Reference Page: 2 of 18

REVISIONS HISTORY

Document No./Revision No. Effective Date Action Description EP-DIR-AP-10020, R0 2/6/14 New Procedure

This procedure supersedes SOP-4006, Document Development and Deliverables Compliance Process.

This procedure defines the process for the development of documents generated by Environmental Programs Directorate organizations.

Removed three attachments and incorporated the content into the body of the procedure.

Added information on DOE’s participation in the decision peer review process;

processing communication record forms;

tracking deliverables; and determining documents that are not sent to the Electronic Public Reading Room.

EM-AP-10087, R0 2/22/2017 New Procedure This procedure was cancelled in the ADEM system and is being reissued as a new procedure with a new number.

N3B-AP-ER-0001, R0 2/13/19 Major Revision New procedure issued to change the procedure number, to address N3B blue sheet revisions, and to make changes to work flow to reflect N3B practices. This document supercedes Blue Sheeted EM-

AP-10087.

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TABLE OF CONTENTS

Section Page

TITLE PAGE

REVISION HISTORY

TABLE OF CONTENTS

1. PURPOSE

2. SCOPE

3. REFERENCES

4. RESPONSIBILITIES

5. PRECAUTIONS AND LIMITATIONS

6. PREREQUISITE ACTIONS

6.1 Document Services Request Form

6.2 Training

6.3 Planning and Coordination

6.4 Materials, Equipment, and Writing Resources

6.5 Decision Peer Reviews

6.6 Preliminary Communications and Concurrence

6.7 Certifications

7. PERFORMANCE

7.1 Preparing Drafts for Review

7.2 Preparing Documents That May Require ONLY Peer Review

7.3 Review Process

7.4 Using the Accelerated Approach

7.5 Preparing the Submittal Letter

7.6 Preparing the Final Document

7.7 Signature (Blue Folder) Process

7.8 Submittal of Final Document

7.9 Distribution and Archiving

8. RECORDS

9. APPENDICES

Appendices Appendix A, Document Development Process Flow Chart Appendix B, Example Document Services Request Form

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1. PURPOSE

This procedure describes the process used by the Environmental Remediation (ER) Program of

Newport News Nuclear BWXT–Los Alamos, LLC (N3B) to produce documents under the Los Alamos Legacy Cleanup Contract (LLCC). Documents are produced for the U.S. Department of Energy (DOE), the New Mexico Environment Department (NMED), the U.S. Environmental Protection Agency (EPA), local and tribal governments, and other N3B organizations, when requested. Documents include regulatory reports and correspondence, as well as technical reports, posters, presentations, and procedures.

NOTE Documents that are contract deliverables are submitted to DOE and should be prepared following N3B-AP-ER-0004, Document Development for Contract Deliverables.

2. SCOPE

This process guides staff in planning, scheduling, tracking, developing, editing, formatting, reviewing, signing, producing, submitting, and distributing documents. A flow chart of the document development process is included as Appendix A. This procedure becomes applicable once a document author/designee completes N3B-Form-6123, Document Services Request Form (an example is shown in Appendix B) and submits it to the Regulatory Documentation Manager.

3. REFERENCES

N3B-AP-ER-0002, Peer Review of Documents/Deliverables

N3B-AP-ER-0003, Deliverables Tracking and Reporting

N3B-AP-ER-0004, Document Development for Contract Deliverables

N3B-AP-RCG-0001, Formalizing Regulatory Communications

N3B-AP-SDM-1200, Requesting and Managing Data Sets

N3B-Form-6123, Document Services Request Form

N3B-P1020-1, N3B Records Management

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4. RESPONSIBILITIES

Author/Designee

• Determines the document type and assesses available information to develop the document, such as historical information that can be found by searching the Potential Release Site (PRS) Website, previous submittals to NMED or any other administrative authority, Compliance Order on Consent (Consent Order) and EPA Individual Permit for Storm Water Discharges (IP) requirements, and/or data or maps.

• Gives the Regulatory Documentation Manager adequate notice and fills out N3B-Form-6123, Document Services Request Form (example shown in Appendix B) for all document-related requests. A Document Services Request Form should be submitted as soon as pertinent information is available and does not have to be provided at the same time as the draft document. Documents that require peer review and DOE review (Consent Order or IP deliverables) should be submitted to the Regulatory Documentation team at least 1 month before the due date, depending upon document size and complexity.

NOTE If a document requires peer review but does not require editing or compositing, see Section 7.2.

• Meets with project manager, subject matter experts (SMEs), Regulatory Documentation team, and subcontractor personnel to (1) develop a schedule that includes deadlines for writing assignments, reviews, comment incorporation, final draft submission, final editing and composition, and signatures and (2) determine the resources needed (e.g., editing, composition, geographic information system [GIS] resources, data, illustration).

• Emails schedule to project staff working on the document. Communicates changes in document logistics to the Regulatory Documentation Manager as necessary.

• Consults with the data and GIS teams about data and map/figure requirements and requests the GIS specialist prepare new maps, as necessary. Requests the necessary data for the document from the data steward. The data may also be requested by the subcontractor.

• Schedules a decision peer review if necessary. DOE counterparts must be included in the decision peer review, the formal peer review, and any key decision phases.

• Coordinates resources and obtains templates and previous versions from the Regulatory Documentation Manager to produce 95% draft.

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NOTE Authors must obtain written approval to use copyrighted material. Referenced materials cited in documents that are not already in the Master Reference Set, including books, must be provided to NMED. Authors can contact the Regulatory Documentation Manager to verify the appropriate copyright use for journal articles, books, or other referenced materials. Authors can also contact the Regulatory Documentation Manager to obtain EMIDs used to reference works cited in documents.

• Ensures the schedule is followed and adjusted as necessary and reports progress and any issues that may arise to the Program Director and the Regulatory Documentation Manager as needed.

NOTE Documents that include data from San Ildefonso Pueblo must be reviewed by the Pueblo before submittal to the regulator. The review period is 60 days, and the author is responsible for ensuring the review is conducted and appropriate time is included in the document schedule.

Regulatory Documentation Team

NOTE The Deliverables Action Tracking System (DATS) is the official database for tracking deliverables to a regulatory authority. Refer to N3B-AP-ER-0003.

• Assigns document catalog numbers. This number is unique to N3B and signifies the start of the document process.

• Requests number from N3B Document Control or DOE for the submittal letter. Note that multiple documents of the same type that are submitted under one cover letter will each have a document number (e.g., periodic monitoring reports or IP certificates of completion).

• Edits and composites the document based on the schedule established by the completed Document Services Request Form.

• Adds document information to DATS. Maintains the database and tracks deliverable information, including notifications, due dates, signature dates, completion dates, staff resources, peer review, and N3B document numbers.

• Produces final documents, delivers documents to regulatory authorities and customers, and distributes final documents.

Project Manager

• Meets with author/designee and others to develop schedules and resources for document development.

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• Determines if a decision peer review is required and conducts the peer review. Documents the review and distributes outcomes to project team.

5. PRECAUTIONS AND LIMITATIONS

The author/designee is ultimately responsible for the document’s quality and schedule and for obtaining required approvals. The author/designee and the Regulatory Documentation Manager must work together to complete the process.

If a document due date falls on a weekend or on a holiday, the document is due to the regulator on the preceding weekday. The author/designee must identify whether the document must be delivered to external parties (e.g., local governments, EPA) at the same time it is delivered to the administrative authority and/or regulator.

6. PREREQUISITE ACTIONS

6.1 Document Services Request Form

The author/designee completes N3B-Form-6123, Document Services Request Form (see example in Appendix B) and submits it to the Regulatory Documentation Manager. The Regulatory Documentation team assigns a document catalog number to the document once the Document Services Request Form is received, signaling the initiation of the document development process.

Note that assignment of an EMID number (formerly an ERID or an ESHID number), which occurs during records submittal, signifies the end of the document process.

6.2 Training

Personnel using this procedure are expected to have completed basic site and job function training.

No additional training is required to execute this procedure.

6.3 Planning and Coordination

Planning and coordination steps required for development of documents are reflected in the procedure performance in Section 7.

6.4 Materials, Equipment, and Writing Resources

Only standard office equipment and materials are required for this procedure. Authors/designees can use this procedure along with tools for document development, including the following:

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• Editing and Compositing Guidelines

• Writing resources o Checklists o Templates o Master acronym list o List of references with EMIDs/ERIDs/ESHIDs

6.5 Decision Peer Reviews

Decision peer reviews may be conducted before document preparation or at a key decision phase.

The review focuses on the appropriateness of the stated objectives for any problems or issues identified; the proposed approach to address the objectives; important assumptions; deliverable milestones; and any risks, issues, and contingencies. DOE representatives must be included in the decision peer review for documents that will be submitted to NMED, EPA, or DOE to ensure DOE input is captured and documented. Project managers are responsible for deciding if decision peer reviews are conducted and for documenting any review output.

Project Manager [1] DETERMINES if a decision peer review is required.

[2] CONDUCTS decision peer review with project team.

[3] DOCUMENTS and DISTRIBUTES review outcomes to project team.

NOTE Formal peer reviews are conducted when the document reaches the 95% draft stage. See N3B-AP-ER-0002, Peer Review of Documents/Deliverables, and note that formal peer review is coordinated by the Regulatory Documentation Manager.

6.6 Preliminary Communications and Concurrence

Per N3B-AP-RCG-0001, Formalizing Regulatory Communications, communication records are processed through the Regulatory Documentation team because the information therein may affect regulatory due dates, commitments, submittals, and project scope or trigger new commitments to regulators.

NMED’s general expectations and guidance for reporting and document formats are included in Appendix E of the Consent Order available at https://www.env.nm.gov/hazardous-waste/lanl.

https://www.env.nm.gov/hazardous-waste/lanl

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6.7 Certifications

Certification statements are required for documents prepared under the IP, and for other documents as applicable.

7. PERFORMANCE

7.1 Preparing Drafts for Review

Author/Designee [1] DETERMINES the SMEs to draft the document.

[2] ASSIGNS sections and due dates to SMEs if more than one author is working on the document.

[3] REVIEWS completed sections and PROVIDES feedback to the author(s) or subcontractor.

[4] RECEIVES 95% completed peer review draft from the in-house authors or subcontractor.

NOTE Subcontractor staff preparing drafts for peer review must use current templates, follow the Editing and Compositing Guidelines, and use the tools listed in section 6.4.

[5] REQUESTS the reporting data set as necessary from the data steward per N3B-AP-SDM-1200, Requesting and Managing Data Sets.

[6] REQUESTS base maps from a GIS specialist as necessary.

[7] ENSURES that the assigned data steward has provided the final data set and that the GIS specialist validates the spatial data.

[8] COORDINATES file transfer to the Regulatory Documentation team, including

SUBMITTING electronic Microsoft Word files of the document, SUBMITTING source files for maps (i.e., Adobe Illustrator or Acrobat), and SUBMITTING any other files needed for delivery to the administrative authority (e.g., data files).

NOTE These files are now the master files, and any changes must be coordinated through the assigned compositor or editor.

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Compositor [9] SETS UP electronic folders and DISCUSSES document particulars with editor.

Editor [10] EDITS before peer review unless the schedule is condensed, RESOLVES queries and

REVIEWS editorial changes with the author/designee, and INFORMS the compositor when edited pieces are ready to format.

[11] USES the Editing and Compositing Guidelines and editing checklist.

Compositor [12] COMPILES and FORMATS the peer review draft according to the Editing and

Compositing Guidelines and composition checklist.

[13] INFORMS the Regulatory Documentation Manager when the file(s) are ready for peer review.

7.2 Preparing Documents That May Require ONLY Peer Review

Examples of documents that are peer reviewed, but not edited and composited, include maps, drawings, statements of work, and safety and security plans and reports.

Author/Designee [1] COMPLETES N3B-Form-6123, Document Services Request Form, and REQUESTS peer review only.

[2] ALLOWS appropriate time for review and reconciling and incorporating comments.

[3] ASSIGNS a document catalog number.

[4] COORDINATES the peer review.

Author/Designee [5] FINALIZES the document and OBTAINS required signatures within document, as appropriate.

[6] SUBMITS complete document to Regulatory Documentation Manager.

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Regulatory Documentation Team [7] SCANS the final document.

[8] ASSIGNS an EMID number and SUBMITS the document to N3B Records.

7.3 Review Process

NOTE Most documents go through the peer review and comment resolution process. The length of this review process depends on the length and complexity of the document.

Allow at least 2 weeks for final editing and composition and for obtaining signatures.

[1] REQUESTS peer review on the Document Services Request Form in accordance with

N3B-AP-ER-0002, Peer Review of Documents/Deliverables.

[2] RETURNS the document to the editor and compositor for final editing and compositing after peer review comments have been addressed and incorporated.

7.4 Using the Accelerated Approach

Documents that have a shorter schedule for completion follow the accelerated approach. Some examples include documents triggered by storm water sampling and revisions to previously published documents.

[1] SUBMITS a Document Services Request Form indicating the need for an expedited peer review (shorter review time and fewer reviewers) for a document going through the accelerated process.

Regulatory Documentation Manager

NOTE 1 For major changes, such as revisions, the document is reissued in its entirety as a “Revision 1” because the content has changed significantly.

NOTE 2 For minor changes, such as replacing pages, correcting grammar or spelling, renumbering, or making changes that do not affect content, the document does not require the same level of review and approval as the original.

[2] SUBMITS the document for a peer review.

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7.5 Preparing the Submittal Letter

Regulatory Documentation Manager [1] EMAILS the draft submittal letter to the author/designee to modify content and to update the standard distribution list, as appropriate.

Author/Designee [2] REVIEWS the draft letter and INCLUDES any relevant information regarding the document, including adding to the standard distribution list, indicating whether additional hard copies must be produced, and indicating if the document proposes future/additional scope or documents.

[3] SUBMITS the final draft submittal letter to the Regulatory Documentation Manager to finalize and prepare the blue folder (for the signature process) as described in Section 7.7.

7.6 Preparing the Final Document

Editor [1] RECEIVES final draft of document for editing from the author/designee or designee.

[2] PERFORMS a full edit and REVIEWS editorial changes and RESOLVES any queries with the author/designee.

Compositor

[3] RECEIVES final edited draft of document from the editor and PERFORMS final composition.

[4] PRINTS a final review copy of the document, ASSEMBLES a complete document

(including CD/DVD labels and plates), and PROVIDES the document to an editor or compositor not assigned to the document to perform a final document check using the in-house checklist.

[5] MAKES any corrections based on the final document check and REPRINTS pages.

[6] PRODUCES final document for author/designee to approve.

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Author/Designee [7] REVIEWS final and makes additional changes and APPROVES by signing the final document checklist (for large documents) and/or the blue folder signature form, indicating the document is complete and ready for production.

7.7 Signature (Blue Folder) Process

Regulatory Documentation Manager [1] ASSEMBLES blue folder with the submittal letter, document(s), and the signature form. If applicable, includes certification page.

NOTE 1 The N3B signature process takes approximately 2 days. DOE requires 5 full days to review and sign. At DOE, the deliverables sign-in sheet must be completed to record when the document was dropped off and picked up to ensure deadlines are met.

NOTE 2 DOE often “reviews” the document during the 5-day review and signature timeframe, and significant changes may occur.

NOTE 3 The blue folder signature form lists reviewers/approvers who sign vouching that the document(s) meets technical, programmatic, and regulatory requirements. Reviewers include the author, technical reviewer (as necessary), project manager, regulatory compliance reviewer, and program director(s).

[2] ROUTES the blue folder and document to other signatories for review and signature or

TRACKS the routing.

[3] Once signatures are complete, SUBMITS the folder and document to DOE (and signs in the document).

Author/Designee [4] COORDINATES with DOE to resolve any comments. WORKS with Regulatory

Documentation team to make changes and reprint pages.

[5] RECEIVES the blue folder and document with all DOE signatures.

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[6] PRODUCES final copies.

NOTE 1 For Consent Order deliverables, Compositor prepares two copies for NMED, one copy for DOE, and one copy for the author/designee at the time of the NMED delivery. The remaining distribution can be completed after the document has been submitted.

NOTE 2 For EPA or other deliverables, Compositor prepares files as noted on the distribution list or the associated Document Services Request Form.

7.8 Submittal of Final Document

Regulatory Documentation Team [1] ENSURES documents are delivered as follows, and CONFIRMS delivery is documented via a date/time stamp.

• Documents under the Consent Order are hand-delivered to NMED in the form of two hard copies with accompanying CDs/DVDs and the original submittal letter; non– Consent Order documents may have different requirements. Correspondence without attachments is hand-delivered in the form of one hard copy or may be emailed. NMED date stamps a copy of the submittal letter to verify the document was received.

• Documents are delivered to the EPA via U.S. certified mail in the form of one hard copy with accompanying CD/DVD (as necessary). The domestic return receipt card is filled out and the box checked for certified mail. A certified mail receipt is obtained and scanned along with the submittal letter to verify the document was mailed. This return receipt card is sent back to the Regulatory Documentation Manager and verifies that the document was received. The card is scanned and archived in the respective document folder.

• Documents for local and tribal governments are emailed, and originals are hand-delivered or sent via U.S. mail, as appropriate. If hand-delivered or sent via U.S. mail, a copy of the submittal letter serves as the date stamp to verify delivery.

[2] SCANS and ARCHIVES the electronic copy of the date-stamped letter on the N3B network

Pubs drive.

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7.9 Distribution and Archiving

For any document, the compositor prepares the hard copies for distribution as indicated on the submittal letter. This distribution also includes submittal to N3B Records, the Electronic Public Reading Room (EPRR) (as applicable), the Hard Copy Public Reading Room (HPRR) (as applicable), and local governments.

NOTE 1 For some deliverables, there are EPRR/HPRR deadlines, and distribution must be completed immediately (the next day).

NOTE 2 The following documents are not submitted to the EPRR or HPRR: air-monitoring reports, spill responses, access agreements, communication records, contract deliverables to DOE, and internal project plans and reports.

[1] ENSURES all final document files are in the document folder and properly named and organized.

Regulatory Documentation Manager [2] DISTRIBUTES documents according to the distribution list in the submittal letter, including submittal to Records, and FOLLOWS the distribution checklist.

[3] SCANS and ARCHIVES all relevant document forms in the appropriate document folders.

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8. RECORDS

Records generated by this procedure will be submitted to the designated Records Management point of contact in accordance with N3B-P1020-1, N3B Records Management. The creation and management of communication records are defined and managed by N3B-AP-RCG-0001, Formalizing Regulatory Communications. However, communication records are processed through the Regulatory Documentation Team because the information therein may affect regulatory due dates, commitments, submittals, and project scope or trigger new commitments to regulators.

Record Identification Record Type

Determination Protection/Storage

Methods Processing

Information Final deliverable or document

Non-QA record This document is archived in N3B electronic storage as outlined in N3B- P1020-1.

When a document is ready for final disposition, it is transferred to Records Management in accordance with N3B- P1020-1.

Communication record Non-QA record This record is archived in N3B electronic storage as outlined in N3B- P1020-1.

When a communication record is ready for final disposition, it is transferred to Records Management in accordance with N3B- P1020-1.

9. APPENDICES

Appendix A, Document Development Process Flow Chart Appendix B, EXAMPLE Document Services Request Form

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APPENDIX A

Document Development Process Flow Chart

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APPENDIX B

EXAMPLE Document Services Request Form

(Obtain the current version of N3B-Form-6123 from the Regulatory Documentation Manager or Document Control)