# Draft Quality Assurance Project Plan for Use of the Existing Data in EPA’s Screening-Level Analyses for Review of Industrial Discharges

Prepared for:



## U.S. Environmental Protection Agency Engineering and Analysis Division Office of Water 1200 Pennsylvania Avenue, NW Washington, D.C. 20460

Prepared by:



## Eastern Research Group, Inc. 14555 Avion Parkway Suite 200 Chantilly, VA 20151-1102

October 2011

EPA Contract No . 68-C-02-095 Work Assignment 9-05This page is intentionally blankTITLE AND APPROVAL SHEET

Quality Assurance Project Plan for Use of Existing Data in EPA’s Screening-Level Analyses for Review of Industrial Discharges

10/24/2011 Eleanor Codding - ERG Work Assignment Manager Date

10/24/2011 Mary Willet - ERG Project Quality Assurance Coordinator Date

10/24/2011 Deborah Bartram - ERG Program Manager Date

Meghan Hessenauer - EPA Technical Projec t Officer (ERG Support Contract) Date

William Swietlik - EPA Work Assignment Manager (ERG Support Contract) Date

Samantha Lewis - EPA Alternate Work Assign ment Manager (ERG Support Contract) Date

Jan Goodwin - EPA Branch Chief, T echnology and Statistics Branch Date

Marion Kelly - EPA/EAD Quality Assurance Manager DateHistory of QAPP for Use of Existing Data in EPA’s Screening-Level Analyses for Review of Industrial Discharges

Revision 0
Delivery Date October 24, 2011
Work Assignment 9-05
Scope Existing data for screening-level analyses

Comments Received NA

Comments Addressed NA
Approval NA
NA – Not yet received, addressed, or approved.Distribution

This Quality Assurance Project Plan (QAPP) will be distributed to staff of the U.S. Environmental Protection Agency and Eastern Re search Group, Inc. (Table 1). A copy of the document will be provided to all Eastern Resear ch Group, Inc. staff involved in the project, including those who join the proj ect after publication of the QAPP.

Table 1. QAPP Distribution

Name
Title Contact Information Mailing Address

U.S. Environmental Protection Agency
Meghan Hessenauer Technical Project Officer (202) 566-1040 Hessenauer.Meghan@epa.gov U.S. Environmental Protection Agency Office of Science and Technology 1200 Pennsylvania Avenue, NW (4303T) Washington, DC 20460 (202) 566-1053 (fax) Marion Kelly Quality Assurance Manger (202) 566-1045 Kelly.Marion@epa.gov

William Swietlik Work Assignment Manager (202) 566-1129 Swietlik.William@epa.gov

Jan Goodwin
Branch Chief (202) 566-1060 Goodwin.Janet@epa.gov
Eastern Research Group, Inc

Deborah Bartram ERG Program Manager (703) 633-1669 Deborah.Bartram@erg.com

Eastern Research Group, Inc. 14555 Avion Parkway
Suite 200 Chantilly, VA 20151-1102 (703) 263-7280 (fax) Mary Willett ERG Corporate Quality Assurance Manager and Project Quality Assurance Officer (703) 633-1615 Mary.Willett@erg.com

Eleanor Codding Work Assignment Manager (703) 633-1673 Eleanor.Codding@erg.com
Teresa Medley ERG Project Assistant (703) 633-1655 Teresa.Medley@erg.com

Elizabeth Sabol
Task Lead (703) 633-1659 Elizabeth.Sabol@erg.com
Jessica Gray Chemical Engineer (703) 633-1681 Jessica.Gray@erg.com
Kimberly Landick Environmental Engineer (703) 633-1119 Kimberly.Landick@erg.comi CONTENTS

Page

1. I NTRODUCTION .................................................................................................................... 1

2. P ROJECT M ANAGEMENT ...................................................................................................... 3
2.1 Project Organization and Responsibilities .............................................................. 3
2.2 Special Training and Certifications ........................................................................ 5
2.3 Project Records ....................................................................................................... 5
2.4 Assessment of QAPP Implementation .................................................................... 6
2.5 Project Status Reports for Management ................................................................. 7

3. P ROJECT D ESCRIPTION AND O BJECTIVES ............................................................................. 8
3.1 Problem Definition/Background ............................................................................. 8
3.2 Project Description .................................................................................................. 9

4. D ATA N EEDS
, S OURCES
, AND Q UALITY C RITERIA ............................................................. 10
4.1 Data Needs ............................................................................................................ 10
4.2 Data Sources ......................................................................................................... 10
4.2.1 Toxics Release Inventory (TRI) Expansion Sector Program Data
Sources..... ................................................................................................ 10
4.2.2 Office of Chemical Safety and Pollution Prevention (OCSPP) and
Office of Pollution Prevention a nd Toxic Substances (OPPTS) Program Data Sources............................................................................... 11
4.2.3 OAQPS Data Sources ............................................................................... 11
4.2.4 Office of Water Sewage Sludge Survey Data Sources ............................. 11
4.2.5 Additional Data Sources ........................................................................... 11
4.3 Data Quality Criteria and Specifications .............................................................. 12
4.3.1 Existing EPA Data Sources ...................................................................... 12
4.3.2 Existing Data Related to Environmen tal and Human Health Effects ....... 13

5. D ATA A CQUISITION
, R EVIEW
, Q UALITY V ERIFICATION
, AND R EPORTING ......................... 17
5.1 Data Acquisition and Documentation ................................................................... 17
5.2 Data Storage and Management ............................................................................. 17
5.3 Data Review .......................................................................................................... 18
5.4 Data Quality Verification ...................................................................................... 18
5.5 Data Quality Reporting ......................................................................................... 19

6. U SE OF E XISTING D ATA ..................................................................................................... 19
6.1 Data Summary or Analysis ................................................................................... 19
6.2 Technical Review of Data Analysis ...................................................................... 19
6.2.1 Methodology Documentation a nd Conceptual Review ............................ 19
6.2.2 Developmental Review ............................................................................. 20
6.2.3 Final Product Technical Review ............................................................... 20
6.3 Validation of Analysis Results.............................................................................. 20
6.4 Reconciliation with User Requirements ............................................................... 20

7. P ROJECT R EPORTS (D ELIVERABLES ) .................................................................................. 21CONTENTS (Continued)

Page

ii 8. R EFERENCES ...................................................................................................................... 21

Appendix A: PROJECT FILE MANAGEMENT PLANiii LIST OF TABLES

Page

Table 2-1. Reporting QA/QC Activities ......................................................................................... .8

Table 3-1. Key Products and Milestones .......................................................................................1 0

Table 4-1. Data Source s Acceptance Criteria ................................................................................15

Table 7-1. Project Deliverables ............................................................................................... .......21iv LIST OF FIGURES

Page

Figure 2-1. Project-Level QA Organization for Existing Data Anlaysis .........................................4

Figure 5-1. Telephone Cont act Report Form .................................................................................18Revision No. 0 Date: October 24, 2011 Page 1 of 22

1. I NTRODUCTION

Overview. EPA’s Engineering and Analysis Division (EAD) is conducting an annual review of existing effluent lim itations guidelines and standards (ELGs) and identification of possible new ELGs. This review will be presented in the 2012 Final Effluent Guidelines Program Plan , to be published in 2012. Under Work Assignment 9-05 of Contract No. 68-C-02- 095, ERG is providing technical s upport to EPA in conducting its annual review of existing ELGs and identifying and evaluating new source s of wastewater discharges. This support includes evaluating facilities or categories ba sed on the considerations contained in EPA’s Strategy for National Clean Water Industrial Regulations , namely those facilities or categories that discharge significant quantities of pollutants capable of causing water quality impairments or of impacting human health. EPA evaluates the re lative hazard to human health and aquatic life using EPA-provided toxic weight ing factors. EPA’s annual revi ew includes these steps:

1. Annual screening-level analysis to prioritize categories.

2. Preliminary review of existing ELGs to i nvestigate discharges from prioritized categories and to investigate stakeholder recommendations and comments.

3. Detailed studies of prioritized ELGs to investigat e pollutant sources and pollutant reduction approaches, to determine if EPA should identify prioritized categories for possible revision of their existing effluent limitations guidelines and/or pretreatment standards.

4. Identification of potential new s ources of wastewater discharges through
evaluation of new data sources.

Under the Revised Quality Assurance Project Pl an for the 2009 Annual Screening-Level Analysis of TRI, ICIS-NPDES, and PC S Industrial Category Discharge Data (September 2009), ERG conducts analyses for the firs t step. This Quality Assurance Pr oject Plan (QAPP) covers the fourth step, identification of potential ne w sources of wastewater discharges.

Under previous work assignments, ERG prepared, and EPA approved three related QAPPs:

 Quality Assurance Project Plan for the Sc reening Level Analysis of TRI and PCS Industrial Category Discharge Data (February 2004);

 Quality Assurance Project Plan for the 2007 An nual Screening-Level Analysis of TRI and PCS Industrial Category Discharge Data (March 2007); and

 Revised Quality Assurance Project Plan fo r the 2009 Annual Screening-Level Analysis of TRI, ICIS-NPDES, and PCS I ndustrial Category Discharge Data (September 2009).

The previous QAPPs outline the quality assuranc e procedures for the annual screening-level analysis. This QAPP is a project-spec ific supplement to ERG’s corporate Quality Management Plan for Technical Support for th e Strategy for National Clean Water Industrial Regulations

, June 2002 (QMP) (ERG, 2002) which was prepared in accordance with EPA Requirements for Quality Management Plans (U.S. EPA, 2001b). ERG’s QMP details the responsibilities of theRevision No. 0 Date: October 24, 2011 Page 2 of 22

ERG Quality Assurance (QA) coordinators a nd Project Management Team and describes procedures used to plan, implement, and asse ss project quality. ERG will use these procedures,
tailored to the needs of the task ed activities, in the 2012 screening- level analysis of existing data

sources.

EPA’s Quality Guidelines . In response to guidelines issu ed by the Office of Management and Budget (OMB, 2002) under Section 515 of the Treasury and General Government Appropriations Act for Fiscal Year 2001 (P ublic Law 106-554; H.R. 5658), EPA developed Information Quality Guidelines (EPA, 2002) for ensuring and maximizing the quality of
information disseminated by EPA.

EPA’s Information Quality Guidelines defines quality as

 Objectivity - information is accurate, reli able, and unbiased and its presentation is clear, complete, and unbiased;

 Utility- information is useful for the intended users; and

 Integrity - information is not compromi sed through corruption or falsification either by accident or by unauthorized access or revision. (from EPA, 2003, p. 9)

In executing projects involving the collecti on and use of existing data, ERG will support EPA in meeting these guidelines by:

 Understanding how EPA intends to use th e collected data and collecting data appropriate for that use;

 Working with EPA to develop specificati ons for the required accuracy, reliability, and objectivity of the data, evaluating collected data ag ainst those specifications, and including the results of these evalua tions in intermediate and final project deliverables; and

 Presenting the sources of data, assumpti ons made, and calculations used in all project deliverables. These identificati ons will be sufficiently detailed and transparent to ensure the re producibility of the work by qualified third parties.

QAPP Approval and Distribution. Each QAPP has a signed approval form, title page, table of contents, and EPA-approved document contro l format (see header at the top of each page in this QAPP). During the course of the project , the ERG WAM will circul ate any revision to the approved QAPP to all ERG and EP A project staff. ERG will doc ument the circulation of the revised QAPP to project staff with a signature page for the revision.

History of this QAPP. As directed by Work Assignment 9-05, ERG prepared a detailed Quality Assurance Project Plan (QAPP) addressing the support it will provide for use of existing data in EPA’s screening-level analyses for review of industrial discharges. In previous years, as directed by Work Assignme nt 6-05, ERG prepared the Revised Quality Assurance Project Plan for the 2009 Annual Screening- Level Analysis of TRI, IC IS-NPDES, and PCS Industrial Category Discharge Data (September 2009).

QAPP Organization. This QAPP is organized according to the work flow ERG uses for projects involving the collecti on and use of existing data. Alt hough its organization differs fromRevision No. 0 Date: October 24, 2011 Page 3 of 22

that presented in EPA Requirements for Quality Assurance Project Plans QA/R-5 (EPA, 2001b), it is responsive to all app licable elements of QA/R-5

. The organization of this plan is as follows:

 Section 2 Project Management

 Section 3 Project Descri ption and Objectives

 Section 4 Data Needs, Sources, and Quality Criteria

 Section 5 Data Acquisition, Review, Quality Verification, and Reporting

 Section 6 Use of Existing Data

 Section 7 Project Reports (Deliverables)

 Section 8 References

2. P ROJECT M ANAGEMENT

This section addresses pr oject management, including:

 Project organization an d responsibilities;

 Special training and certification;

 Project records;

 Assessment of the implementation of this QAPP; and

 Project status and quality ac tivity reports to management.

2.1 Project Organization and Responsibilities

Project organization for ERG’s collection and use of existing data for support of EPA’s industrial wastewater discharge review is depicted in Figure 2-1. The figure shows staff with program management and technical responsibilities and those with QA/QC roles. It also shows the relationship and lines of authority, re porting, and communicati on among all project participants, includi ng those from EPA.

The ERG Program Manager has overall responsib ility for individual work assignments or directives. She organizes and dire cts the technical activities and functions as the primary liaison between EPA, ERG management, and the proj ect team. Her respons ibilities include:

 Communicating with the EP A client on technical ma tters, the ERG Contract Administrator on contractual matters, a nd ensuring project staff follows the contract requirements;

 Reviewing all work assignments, work plans, cost estimates, technical and financial progress repor ts, and invoices;

 Working with the Project QA Coordi nator and the ERG Work Assignment Manager (WAM) to resolve any qual ity problems that arise; and

 Monitoring the technical activities on the work assignment to ensure that the technical objectives, budget, and schedule are met.Revision No. 0 Date: October 24, 2011 Page 4 of 22

Figure 2-1. Project-Level QA Organization for Existing Data Anlaysis

The ERG WAM will be the principal contact for the EPA WAM on project issues, deliverables, and schedule. The ERG WAM will be responsible for:

 Ensuring that the quality of work, schedul e, and budget meet the requirements of the EPA effluent guidelines program;

 Providing technical directi on to ERG staff and managi ng the daily activities on the project;

 Providing the official, approved QAPP to the ERG project team;

 Obtaining appropriate technical review of all deliverables and ensuring
deliverables conform to EPA’s tech nical review requi rements; and ERG Corporate

QA Manager

ERG Project QA Coordinator

ERG Technical
Reviewers
To be assi g ne d ERG Program Manager

ERG Work Assignment

Mana g e r

ERG
Task Lead

ERG
Staff EPA Project Officer

EPA Work Assignment

Mana g e r

EPA QA Coordinator

Lines of Communication
Re p ortin g and Authorit yRevision No. 0 Date: October 24, 2011 Page 5 of 22

 Keeping the Project QA Coor dinator and the Project Manager advised of any quality problems that arise.

ERG’s QA staff functions independently of the team collecting and analyzing data for this project. Ms. Mary Willet will serve as Proj ect QA Coordinator, responsible for ensuring that the requirements of this QAPP are implemente d and documented. Ms. Mary Willett also serves as ERG’s overall Corporate QA Manager and will ensure that project-sp ecific QA/QC programs are commensurate with project objectiv es and with ERG’s quality system.

The EPA QA Coordinator is responsible for approving the QAPP and for retaining the official approved QAPP. The QA PP is not effective until appr oved and signed by the EPA QA
Coordinator.

2.2 Special Training and Certifications

The owners of the information may classify information and data collected during this project as Clean Water Act Confidential Busine ss Information (CBI). Therefore, ERG will train project staff in CBI-handling procedures as ou tlined in ERG’s CBI security plans. ERG will permit only staff demonstrating their understand ing of CBI handling procedures by passing a written test to access CBI on this project. ERG’s CBI Security Officer, Ms. Laurie Morgan, will maintain a list of all personnel cleared to access Clean Water Act CBI. The ERG WAM will confirm that project personnel are included on this list before they are permitted to access CBI.

ERG will strictly adhere to all EPA proce dures when handling industry CBI. ERG will manage all reports, documents, and other material s and all draft documents developed under this work assignment in accordance with the procedures set forth in ERG’s CBI security plan or its successor approved plan:

 Security Plan for Handling Confidential Business Information Under the Clean
Water Act , dated September 25, 2008 and a pproved by Ahmar Siddiqui, EPA’s
Document Control Officer for this contract, on March 12, 2009.

2.3 Project Records

ERG has developed and instituted document control mechanisms for the review, revision, and distribution of QAPPs. Each QAPP has a signed approval form, title page, table of contents, and EPA-approved document control format (see head er at the top of each page in this QAPP). During the course of the project, the ERG WA M will circulate any revision to the approved QAPP to all ERG and EPA project staff. ERG will document the ci rculation of the revised QAPP to project staff with a signature page for the revision.

ERG will handle and store all information colle cted, generated, and analyzed during this project in a centralized record. This centralized record cont ains all data collected or accessed from other sources and documents analyses of data collected (e.g., li terature reviews and database analyses). During the period of perfor mance, all project file s, including interim or working files and final project deliverables, wi ll be located and mainta ined on a computer at ERG’s facilities and will be backed up daily. An y files that contain CBI will be maintained on
ERG’s secure CBI server.Revision No. 0 Date: October 24, 2011 Page 6 of 22

The ERG WAM is responsible for establishing and ensuring that vers ion control is used for all project documents. Under this work a ssignment, the version of interim and working documents will be identified in the document and in the electronic file name using a sequential numbering or dating scheme. First versions may or may not have the version indicated as “v0.” Historical files will be kept and maintained in th e project file. Final versions of documents will
be identified in the electronic filename as “FINAL.”

At the conclusion of each year of the annua l review, ERG will copy a ll docket files to a DVD disk and provide it to the EPA WAM. ERG will retain a copy of project electronic files in the ERG archive and will return paper ma terials to the EPA WAM, as directed.

ERG’s WAM is responsible for designating an individual to maintain all project files, known as the index keeper. She is also responsib le for ensuring that project team members document all data sources used. ERG is using a pr oject file management plan for this project adapted from similar plans prepared for othe r work assignments on Contract No. 68-C-02-095. The plan provides detailed instructions for de veloping a project index us ing a Microsoft Office AccessTM database and a system to manage informa tion collected on this project. This system is compatible with the needs of the Federal Do cket Management System (FDMS). The ERG WAM has assigned the “index keeper ” the responsibility of maintain ing the file index and filing documents in the electronic project file.

The 304m Project File Management Plan (Appendix A) includes detailed procedures for ensuring the quality of the project file and docket and for quality checks that will be performed during the assembly of th e public and CBI dockets.

2.4 Assessment of QAPP Implementation

ERG will conduct several stages of review during the plan ning and execution of this project to assess that the procedures outlined in this QAPP are followed. All tasks conducted and products generated receive (1) a conceptual revi ew, (2) a developmental review, and (3) a final product review.

The ERG program manager and senior engine ers with effluent guidelines knowledge who are not directly involved in th e work assignment will provide a conceptual review during the initial stages of work development. This review will ensure that the fi nal product and associated documentation address the needs set forth by th e EPA WAM, the work assignment, and this QAPP.

The quality of intermediate deliverables and final products is also evaluated as these work products evolve. This developmental review includes, for example, (1) checks on calculations and data quality and (2) reviews of dr aft documents to ensure that the direction of work is consistent with the conceptual review outline.

ERG’s WAM will conduct a final product technical review of all deliverables prior to delivery to EPA. Technical review is a documen ted critical review of work that has been performed within the “state of the art.” In addi tion, reports and memoranda to the record will be reviewed by a senior-level engi neer (for engineering activities) not direct ly involved with theRevision No. 0 Date: October 24, 2011 Page 7 of 22

product. All deliverables will subsequently be reviewed by the EPA WAM. ERG will document all reviews of project deli verables in a deliverable review tracking spreadsheet.

ERG’s Project QA Coordinator for this project or her designee will assess the implementation of QA/QC procedures on this project as follows:

 Review the QAPP (this document) for completeness and applicability; and

 Audit project files to ensure and verify the following:

— That project staff have develope d QC procedures and that these procedures are used; and

— That project staff are documenting th eir use of these QC procedures by completing checklists, review spread sheets, and other project-specific
forms.

Any quality deficiencies detected by techni cal reviewers or the Project QA Coordinator will be communicated, in writing, to the ER G WAM. The ERG WAM is responsible for ensuring that appropriate correc tive action is taken and reported to the Project QA Coordinator. The Project QA Coordinator will note if, at any tim e, she considers the pr oject to have quality
deficiencies that are not remedied in a timely manner. Upon noting that there are quality deficiencies, the Project QA Coordinator will co nduct a project review as the ERG Corporate QA Manager. If the work is deficient, she wi ll recommend to the ERG Program Manager that work related to these deficiencies be stopped until remedied. The ERG Program Manager will take necessary steps to resolve the issues with the ERG WAM a nd, if appropriate, will notify the
EPA PO and/or WAM of actions taken.

ERG will include any reports of corrective actio ns in the project QA files. At any time or at the end of the project or work assignment, the Corporate QA Manager or her designee may inspect the project QA files.

2.5 Project Status Reports for Management

Monthly, ERG will electronically submit to th e EPA WAM and PO a progress report that documents the costs incurred and work perfor med during the previous accounting period and work planned for the current accounting period.

Additionally, ERG will provide the EPA WAM with monthly reports on the status of quality assurance (QA) activities. These reports w ill be incorporated into our monthly technical progress reports which will be supple mented to include the following:

 Quality assurance activities performed during the reporting period as part of the implementation of the work assignment;

 Identification of any problems encountered;

 Identification of any deviat ions from the QAPP; and

 Identification of problem resolution a nd/or corrective acti ons taken during the reporting period, if any.

Table 2-1 lists the type of QA/QC activitie s that ERG will report to the EPA WAM.Revision No. 0 Date: October 24, 2011 Page 8 of 22

Table 2-1. Reporting QA/QC Activities

Data Generation, Acquisition, and Use QA/QC Activities that ERG will report to EPA in the monthly QA activity report
Existing Data

Collection Evaluate the quality of data using data acceptance criteria.
Follow set procedures when collecting published data or data from telephone/email

contacts. Submit project data and publications to the project file index keeper.
Verify that data sources have been correctly entered into the project file index.
Perform a conceptual review, a developmental review, and a final product review on all
technical memoranda.

ERG will describe QA activities conducted for major deliverables, such as summary memoranda, when such documents are delivered to EPA. These descriptions may be included in the document or in the transmittal email, as directed by EPA.

3. P ROJECT D ESCRIPTION AND O BJECTIVES

This section provides a management-level overv iew of the project a nd its objectives. That is, this section focuses on the purpose of the proj ect. Planned execution of the project is detailed in the following sections:

 Section 4 describes the data needed to answer the questions and problem presented in Section 3;

 Section 5 describes how ERG will obtai n, check, and store collected data;

 Section 6 describes how ERG will use the data by developing data summaries or engineering analyses; and

 Section 7 describes the project deliverables.

3.1 Problem Definition/Background

ERG’s analysis of existing data sources wi ll provide technical support to EPA for their preparation of the 2012 Final Effluent Guidelines Program Plan required by CWA Section 304(m). The key elements in the 2012 Final Effluent Guidelines Program Plan are as follows:

 Annual review of effluent guidelines a nd pretreatment standards that EPA has promulgated under the CWA;

 Identification of categories of source s discharging toxic or nonconventional pollutants for which guidelines or pretre atment standards have not previously been published; and

 Establishing a schedule for further investigation and/or possible development or revision of effluent guidelines and pretreatment standards.Revision No. 0 Date: October 24, 2011 Page 9 of 22

To prepare its 2012 Final Effluent Guidelines Program Plan , EPA will seek to answer, among others, the following questions:

 What industrial wastewater discharges pose the greatest potential threat to
human health or the environment?

 What industrial wastewater disc harges should be studied further?

 What industrial wastewater discharge s warrant possible ELG development or
revision?

ERG’s analysis of existing data sources will support EPA in answering these questions.

3.2 Project Description

Previous screening-level analyses . On earlier work assignments, ERG supported EPA’s development of the 2004, 2006, 2008, and 2010 Effluent Guidelines Program Plans. This support included developing nine database s of TRI reported releases ( TRIReleases2000

, TRIReleases2002

, TRIReleases2003, TRIReleases2004, TRIReleases2005, TRIReleases2006, TRIReleases2007, TRIReleases2008, and TRIReleases2009 ) and six databases of discharge monitoring report (DMR) discharges ( PCSLoads2000, PCSLoads2002, PCSLoads2004, DMRLoads2007, DMRLoads2008, and DMRLoads2009 ). The following documents describe the development of these databases:

 Technical Support Document for the 2004 Effluent Guidelines Program Plan (U.S. EPA, 2004) ;

 2005 Annual Screening-Level Analysis: Suppor ting the Annual Review of Existing Effluent Limitations Guidelines and Standards and Identification of New Point Source Categories for Effluent Limitations and Standards (U.S. EPA, 2005) ;

 Technical Support Document for the 2006 Effluent Guidelines Program Plan (U.S. EPA, 2006a) ;

 Technical Support Document for the Preliminary 2008 Effluent Guidelines Program Plan (U.S. EPA, 2007) ;

 Technical Support Document for the 2008 Effluent Guidelines Program Plan (U.S. EPA, 2008) ;

 Technical Support Document for the Preliminary 2010 Effluent Guidelines Program Plan (U.S. EPA, 2009) ; and

 Technical Support Document for the 2010 Effluent Guidelines Program Plan (U.S. EPA, 2010)

.Revision No. 0 Date: October 24, 2011 Page 10 of 22

ERG’s support for the 2012 Final Effluent Guidelines Program Plan will build on the work from the previous screening-level analyses by includin g new data sources.

The key products ERG will produce and ke y milestones are listed in Table 3-1.

Table 3-1. Key Products and Milestones

Key products and milestones Date Five technical approach memoranda, initial draft October 31, 2011 or as directed by EPA
WAM Five technical approach memoranda, final draft November 30, 2011 or as directed by
EPA WAM Draft report sections documenting findings May 2012 or as directed by EPA WAM All documents drafted to support EPA’s Final 2012
Plan Concurrent with EPA’s draft Final 2012 Plan projected date (August 2012) All documents finalized to support EPA’s Final 2012
Plan Concurrent with EPA’s Final 2012 Plan projected publication date (September 2012)

4. D ATA N EEDS , S OURCES , AND Q UALITY C RITERIA

This section discusses the data needed to answer the key que stions listed in Section 3.1
and describes the sources that ERG w ill review to identify these data.

4.1 Data Needs

To answer the key questions to support the existing data screeni ng-level analyses in preparation of the 2012 Final Effluent Guidelines Program Plan , EPA needs data characterizing industrial wastewater discharges and related treatment residues, and data identifying the sources
of the wastewater.

4.2 Data Sources

This section provides general descriptions of the data sources that ERG will use for this project. Quality criteria and sp ecifications for the collected da ta are discussed in Section 4.3. Section 5.1 provides additional deta ils of how data will be collected and documented. ERG will obtain the existing data from employees and pub lications/databases available from other EPA offices, www.regulations.gov, and other websites.

4.2.1 Toxics Release Inventory (TRI) Expansi on Sector Program Data Sources

ERG will review data collected on Industrial Laundries, which were collected as part of the TRI Program’s consideration of expansion sect ors. ERG will consider these data in concert with existing data, such as data from EPA’ s 1999 Final Action on Industrial Laundries ELGs, which resulted in no rulemaking.Revision No. 0 Date: October 24, 2011 Page 11 of 22

4.2.2 Office of Chemical Safety and Pollution Prevention (OCSPP) and Office of Pollution Prevention and Toxic Substances (OPPTS) Program Data Sources

ERG will screen the latest publications from the OCSPP/OPPTS Programs for new industry categories or potential new pollutant s of concern not currently regulated. These publications will include the High Production Volume (HPV) Program, Significant New Use Rules (SNUR), and the Invent ory Update Rule (IUR).

4.2.3 Office of Air Quality Planning and Standards (OAQPS) Data Sources

ERG will review the recent air emission rules to determine any trends in wet air pollution control and resulting wastewater. These review s will include rules from the National Emission Standards for Hazardous Air Pollutants (NESHA Ps)/Maximum Achievable Control Technology (MACT), New Source Performance Standards (NSPS), New Source Review (NSR)/Prevention of Significant Deterioration (PSD ), and other air programs.

4.2.4 Office of Water Sewage Sludge Survey Data Sources

ERG will examine the Office of Water’s Targeted National Sewage Sludge Survey (TNSSS) for pollutants of concern associated wi th industrial activity, in cluding examining recent
contamination issues associated with the benefici al reuse of biosolids, such as, perfluorinated
chemicals.

4.2.5 Additional Data Sources

ERG will evaluate the possible use of the following data sources to identify any alternative investigation categories:

 Data from EPA’s WATERS program (http://www.epa.gov/waters/):

o Clean Water Act Section 303d data for impaired waters, for impairments resulting from industry discharges . Specifically looking at TMDLs for pollutants such as pathogens, metals other than mercury, mercury, nutrients,
and sediments.

o Newly-developed wate r quality criteria.

o Fish consumption advisories to identi fy pollutants most commonly triggering
advisories.

o High priority targeted watersheds for i ndustrial impacts, such as those in the National Estuary Program.

 OECA enforcement initiatives described in spreadsheets, databases, or reports of
sector information.

 Emerging drinking water and groundwater contamination problems that may be caused by industry by reviewing current Office of Groundwater and DrinkingRevision No. 0 Date: October 24, 2011 Page 12 of 22

Water (OGWDW) priorities and data ware houses and publications from the U.S. Geological Survey.

 New analytical methods that would bette r characterize contamination problems not currently identified in the screening-level databases.

 Reports of new, more effective wastewat er treatment technologies for an existing industry category, including review of public comments and technical conference material to identify new technologies.

 Environmental Justice (EJ) areas develope d using zip code and/or GIS polygons.

 Data received during outreach to industry and non-governmental stakeholders, as well as EPA Region, state, and local organizations.

4.3 Data Quality Criteria and Specifications

The primary objectives of this QAPP are to ensure that:

1. Data generated and collected are of the quality necessary for EPA to identify industrial wastewater disc harges not currently regulated; and

2. The results of the analyses of these data are documented and of the type, quality, transparency, and reproducibility needed.

Measures and descriptions of data quality cr iteria that ERG will use to identify data that
are fit for this use are described in this sect ion. ERG will collect information about industrial wastewater discharges from ex isting data sources. ERG antic ipates collecting data on:

 Industrial sector products a nd pollution control trends.

 Wastewater characteristics.

 Treatment technology performance/efficiency.

 Pollutant loads discharged by industry, facility, and pollutant.

 Treatment technology costs.

 Environmental and human health effects.

The criteria ERG will use to evaluate the qual ity of information collected on these topics are summarized in Table 4-1, along with acceptable values for each criterion. ERG will describe data quality in the QA section of monthly technical progress reports, and as needed in emails that accompany deliverables.

4.3.1 Existing EPA Data Sources

Table 4-1 lists the data sources acceptance crit eria by type of use in relationship to the type of data. Existing data sources will incl ude discharge data (e.g., data received during
stakeholder outreach and database s from other EPA offices such as IUR and WATERS), articlesRevision No. 0 Date: October 24, 2011 Page 13 of 22

and technical papers, industry/vendor data, a nd internet information. Table 4-1 provides the specific circumstances that define when data meet acceptance criteria or when data are unusable.

When existing data are received, ERG will use th e criteria in Table 4-1 to identify if the data are usable for this program. In addition to th e criteria listed in Ta ble 4-1, ERG will evaluate the reasonableness of existing data. For example, pollutants must be reasonably related to the process or waste stream from which they were discharged. ERG may flag data sets as questionable and subject to further investigation if a chemical is de tected that is not expected in the waste stream or if an expected chemical is missing (based on historical data from earlier annual reviews, such as the DMRLoads and TRIReleases databases described in Section 3.2). ERG will communicate to the EPA WAM whether repo rted or calculated pollutant loads, plant wastewater flows, or other existi ng data reflect the range of exp ected values. In addition, if the data provided by a data source are repeatedly found to be unreasonable, ERG will communicate these quality issues to EPA and wait fo r further direction from the EPA WAM.

ERG will not review the quality of existi ng data contained in published EPA databases and data systems (e.g., WATERS) or other database s provided by federal or state agencies or trade organizations but will desc ribe known limitations of the data in reports on which they are based. If ERG identifies limitations in the quality of the data from published literature or federal/state generated databases that may impact decisions regarding th e overall direction of further data collection efforts or the quality of deliverables, ERG will communicate these issues to the EPA WAM. Data limitation discussions will identify where data gaps exist and a description of data re porting requirements.

4.3.2 Existing Data Related to Environmental and Human Health Effects

In addition to the analyses listed in Table 4-1, ERG will also use existing data to support qualitative assessments of the impact of industria l discharges on the environment. These analyses will likely rely on published literatu re identified during review of ma terials related to the targeted analyses. The criteria that ERG will use to eval uate the quality of literature are 1) accuracy, 2) reliability, and 3) representativeness.

Accuracy . ERG assumes that the underlying data and information contained in state and federal reports and peer-reviewed journal articles are accurate. ERG assumes that data from these sources are of sufficient quality to identify potential environm ental impacts associated with industrial discharges. ERG will present data that are outliers (e.g., data that are not consistent with the body of information collected from the li terature review) to EPA for further direction on how to incorporate or exclude the data in the analysis.

Reliability. During the review of existing literatu re, ERG may encounter sources that
contain limited documentation of the environmenta l impact claim (e.g., unidentified speaker at a stakeholder meeting or a local resident commenti ng in a newspaper article). These data sources represent a lower level of reliability than p eer-reviewed literature, but may provide useful information for capturing the full range of envi ronmental impacts associated with industrial discharges. If ERG identifies limitations in the quality of information taken from other existing data sources (e.g., web sites, newspapers, and stakeholder meetings), ERG will communicate these data quality issues to EPA. ERG will also evaluate existing data for use in qualitative analyses for reliability based on the following factors:Revision No. 0 Date: October 24, 2011 Page 14 of 22

 The scientific work is clearly written, so that all assumptions and methodologies can be identified;

 The variability and uncertainty (quantitativ e and qualitative) in the information or in the procedures, measures, methods, or models are evaluated and characterized;
and

 The assumptions and methodologies are consistently applied throughout the analysis as reported in the source.

Representativeness. ERG will evaluate existing data for use in qualitative analyses for representativeness based on whether they represent:

1) The types of environmental impact s caused by wastewater discharges. 2) The range of concentrations. 3) The environments affected (e.g., rivers, lakes, and wetlands).Revision No. 0Date: October 24, 2011Page 15 of 22Table 4-1. Data Sources Acceptance CriteriaType of DataData Not UsableData Usable forIndustrial SectorTrendsData Usable toCharacterizeWastewaterData Usable toDemonstrate SystemPerformance/EfficiencyData Usable toEstimatePollutant LoadsData Usable toEstimate Cost ofTreatmentData Usable forEnvironmentaland HumanHealth EffectsDischarge Data(e.g., Databasesfrom other EPAoffices such asWATERS)(1) Data collectedby an unknownmethod or unitsundefined.(2) Data collectedduring upsetconditions.(3) Represents aprocess that is notof interest (e.g.,sanitarywastewater).Waste streamidentified andanalytesidentified.Waste streamidentified andanalytes, units, anddetection limitsidentified.(1) Represents full-scalesystem.(2) Paired influent andeffluent data shows thattreatment system is welldesigned and operated.(3) Analytes identifiedand units included.Identified asdischarge,analytesidentified andunits provided,approvedanalyticalmethod used,represent currenttreatmentoperations.Data nottypically used forthis purpose.Waste and typeof receivingstream identifiedand analytesidentified.Articles/Technical PapersInformation doesnot address keyquestionsDocumented andreputable sourcesfound throughliterature searches(e.g., peerreviewed journalsand governmentpublications).Waste streamidentified andanalytes, units, anddetection limitsidentified.(1) Represents full-scalesystem.(2) Paired influent andeffluent data shows thattreatment system is welldesigned and operated.(3) Data do not representupset conditions.(4) Analytes identifiedand units and detectionlimits included.Identified asdischarge,analytesidentified andunits provided,approvedanalyticalmethod used,representtreatmentoperations.Cost componentsfully defined andidentified (e.g.,direct andindirect capital,annual operatingandmaintenance),cost yearidentified.Documented andreputable sourcesfound throughliteraturesearches (e.g.,peer-reviewedjournals andgovernmentpublications).Revision No. 0Date: October 24, 2011Page 16 of 22Table 4-1. Data Sources Acceptance CriteriaType of DataData Not UsableData Usable forIndustrial SectorTrendsData Usable toCharacterizeWastewaterData Usable toDemonstrate SystemPerformance/EfficiencyData Usable toEstimatePollutant LoadsData Usable toEstimate Cost ofTreatmentData Usable forEnvironmentaland HumanHealth EffectsIndustry/ VendorDataInformation doesnot address keyquestions.These data aregenerallyacceptable forrelevant sources.Data not typicallyused for thispurpose.(1) Represents full-scalesystem.(2) Paired influent andeffluent data shows thattreatment system is welldesigned and operated.(3) Data do not representupset conditions.(4) Analytes identifiedand units and detectionlimits included.Data nottypically used forthis purpose.Cost componentsfully defined andidentified (e.g.,direct andindirect capital,annual operatingandmaintenance),cost yearidentified.These data aregenerallyacceptable forrelevant sources.InternetInformation (notpublishedarticles ortechnical papers)Information doesnot address keyquestions.These data aregenerallyacceptable forrelevant sources.Data not typicallyused for thispurpose.Data not typically usedfor this purpose.Data nottypically used forthis purpose.Data nottypically used forthis purpose.These data aregenerallyacceptable forrelevant sources.Revision No. 0 Date: October 24, 2011 Page 17 of 22

5. D ATA A CQUISITION , R EVIEW , Q UALITY V ERIFICATION , AND R EPORTING

This section describes how ERG will acquire th e data needed to answer the key questions listed in Section 3.1, describes how ERG will determin e if the data meet the specifications listed in Section 4, and how this determination will be documented. The use of these existing data
sources is described in Section 6.

5.1 Data Acquisition and Documentation

ERG will obtain data from sources such as employees and publications/databases available from other EPA offices, government publications, and scien tific literature.

ERG staff will use the following procedures when collecting published data:

 ERG researchers will collect full bibl iographic information on all collected publications, including “dat e accessed” for information collected from the
Internet.

 ERG researchers will save Web pages as PD F files, so that the data source can be added to the electronic project file.

ERG staff will use the following procedures wh en collecting data via telephone and email

contact.

 ERG researchers will document all telephone contacts using the Telephone Contact Report depict ed in Figure 5-1.

 ERG researchers will save all email contact s as pdf files, so that they can be added to the electronic project file.

 ERG researchers will ensure that telephone contact reports an d email records are added to the electronic project file.

ERG will notify EPA of any data quality limitations during weekly meetings or via email.
ERG will follow EPA WAM direction on which data to include or exclude in the technical review of existing sources for the 2012 Final Effluent Guidelines Program Plan

.

5.2 Data Storage and Management

ERG researchers will submit publications and me ta data to the project file index keeper. The index keeper will add meta da ta describing the publications to the 304m Project File Index. Following the procedures detailed in the project f ile management plan, the index keeper will add the publication file to the 304 m Electronic Project File.Revision No. 0 Date: October 24, 2011 Page 18 of 22

Figure 5-1. Telephone Contact Report Form

5.3 Data Review

According to EPA’s Guidance for QAPPs ( QA/G-5), data review is “the in-house examination to ensure that the data have been recorded, transmitted, and processed correctly. That includes, for example, checking for data entry, transcription, calculation, and reduction errors...It is a completeness check to determine if there are any deficiencies, such as data missing....”

After acquiring existing data, ERG will ensure that the documentation for these data sources has been correctly entered into the projec t file index. ERG will also ensure that the data meet the acceptance criteria in Table 4-1. Informa tion added to the project file will be checked as described in the Project File Ma nagement Plan, which includes pe riodic project file review and project file reviews conduc ted during docket assembly.

5.4 Data Quality Verification

According to EPA’s Guidance for QAPPs (QA/G- 5), data verification is “the process of evaluating the completeness, correctness, and co nformance of a specific data set against the method, procedural or contractua l specifications.” For this proj ect, data verification means the process in which ERG will determine if collected da ta meet the data acceptance criteria specified in Section 4.3. To accomplish this, ERG will check th e data source and/or data itself against the quality criteria of Table 4-1. ERG will also documen t if any data or data sources do not meet the
criteria. Project No.: DISTRIBUTION

Page 1 of 1
Project Name:

TELEPHONE CALL
RECORD

Outgoing Call Date: Time:

Company Name: Contact Name:

Phone No.:

Name:

GENERAL SUBJECT :

TOPICS DISCUSSED AND ACTION TAKENRevision No. 0 Date: October 24, 2011 Page 19 of 22

ERG may use data that do not meet the speci fications if, for example, there are no other available data. ERG will discuss such data qua lity issues with the EPA WAM and obtain his written approval before using thes e data in subsequent analyses. This approval will be added to the project quality file. In its final project repor t, ERG will describe data quality, including any
need to use data that did not meet quality acceptance specifications.

5.5 Data Quality Reporting

As discussed in Section 2.5, ERG will prov ide the ERG WAM with a monthly report of the status of QA activities. ERG will describe da ta quality, including any need to use data that did not meet quality acceptance specifica tions, in its final project report.

6. U SE OF E XISTING D ATA

ERG will use the collected data to compile industrial discharge data for EPA. ERG will follow EPA WAM direction for using the collecte d data to supplement the annual screeninglevel analysis. If any calculations occur, an ERG technical reviewer will verify that any calculations performed reflect the technical approach a nd that original data are correctly input into the spreadsheet.

6.1 Data Summary or Analysis

ERG will review the data sources to determ ine if additional consideration is needed. Examples of data needing additi onal consideration include discharg e data from one year to the next year showing significant incr eases or new technologies identifie d for an industry sector that were not considered in previous ELG rulemakings. If data meet the quality criteria, listed in Table 4-1, ERG will discuss findings with the EPA WAM during weekly status calls. At the direction of the EPA WAM, ERG will summarize the relevant data in memoranda or draft report
sections for EPA’s review.

6.2 Technical Review of Data Analysis

Related to the use of existing data in EP A’s annual review, process, ERG will prepare
memoranda that describe the tec hnical approach to ERG’s analys is of existing data for EPA’s review. ERG will follow the prescribed appr oach once approved by the EPA WAM, reporting findings during weekly meetings. As directed by the EPA WAM, ERG will then summarize findings in report sections or additional memoranda.

The memoranda ERG develops for this project will document the data sources and describe how the data will be used in support of the screening-level anal ysis. They will receive (1) a conceptual review, (2) a developmenta l review, and (3) a fi nal product review.

6.2.1 Methodology Documentation and Conceptual Review

ERG will set up a technical approach in memoranda for EPA review. ERG senior engineers knowledgeable in the development of ELGs, but not directly involved in the work assignment, and the ERG program manager will revi ew these approach memoranda; that is, theyRevision No. 0 Date: October 24, 2011 Page 20 of 22

will provide conceptual review. Their review will ensure that the planned discussion will address the needs set forth by the EPA WAM and the work assignment. The ERG WAM will discuss conceptual review findings with the EPA WA M before the memoranda are completed during weekly meetings.

6.2.2 Developmental Review

An ERG technical reviewer will verify that any calculations performed reflect the technical approach and that origin al data are correctly input into any spreadsheets or databases. ERG will use standard engineering references to document that calculations are appropriate. ERG will review any constants used for appropria teness, will check that units are converted properly, and will document and check the equati ons used in the costing spreadsheets. The spreadsheet reviewer will provide the spreadsheet developer with a written summary of the data checked, any errors or problems found, a nd any recommendations for revisions.

6.2.3 Final Product Technical Review

ERG will summarize findings of targeted revi ew methodologies in memoranda or reports
for EPA WAM review. A senior-level engineer not directly involve d with the project will review the final report. ERG will document this review and record it in th e deliverable review spreadsheet in the project QA files.

6.3 Validation of Analysis Results

According to EPA’s Guidance for QAPPs (QA/ G-5), data validation is “an analyte- and sample-specific process that extends the ev aluation of data beyond method, procedural, or contractual compliance (i.e., data verification) to determine the an alytical quality of a specific
data set.”

ERG will support EPA in validating the re sults of the data summaries by using engineering judgment to evaluate whether the estimates “make sense” in the context of our knowledge of industrial wastewater discharges. This evaluation may include analysis of the results, for example toxic weighting factors. ER G will investigate the input data and assumptions and use engineering judgment to unders tand whether the result is logical.

6.4 Reconciliation with User Requirements

ERG will identify the sources of data, assumptions made, and calculations used in our development in all project deliverables. These identifications will be sufficiently detailed and transparent to ensure the re producibility of the work by qualified third parties.

ERG will include an evaluation of data and data analysis quality in all project deliverables and during weekly meetings. Any limita tions of the data and data analyses will be described in all project deliverables, but EPA will decide how to use the data and data analyses.

ERG will compare findings to known values to verify results, including overall industry trends, pollutant loadings, and geographic scope. For example, ERG will use results from previous years’ findings, including published screen ing-level databases, the TRIReleases andRevision No. 0 Date: October 24, 2011 Page 21 of 22

DMRLoads databases and the most recent Preliminary and/or Final ELG Plans described in Section 3.2 of this QAPP. Additionally, ERG will report how well the data collected and analyzed for this project answer the key quest ions identified in Section 3.1 of this QAPP.

7. P ROJECT R EPORTS (D ELIVERABLES )

The key products ERG will produce and how da ta quality will be reported in each are
listed in Table 7-1.

Table 7-1. Project Deliverables

Key products Data Quality Report Content

Five Technical Memoranda  The ERG WAM will discuss memoranda conceptual review findings with
the EPA WAM.
2012 Final Plan  Supporting documentation as directed by the EPA WAM: additional memoranda or report section. Documentation will assess how well project collected and analyzed data answer the key questions.

 Executive summary will discuss limitations of the collected data.

8. R EFERENCES

EPA, 2001. U.S. Environmental Protection Agency. EPA Requirements for Quality Assurance Project Plans QA/R-5 . EPA/240/B-01/003. Office of Environmental Information. March 2001.

EPA, 2002. U.S. Environmental Protection Agency. Guidance for Quality Assurance Project Plans QA/G-5 . EPA/240/R-02/009. Office of Environm ental Information. March 2001.

EPA, 2002. U.S. Environmental Protection Agency . Guidelines for Ensuring and Maximizing the Quality, Objectivity, Utility, and Integrity of Information Dissem inated by the Environmental Protection Agency. EPA/260R-02-008. October 2002.

EPA, 2003 U.S. Environmental Protection Agency. A Summary of General Assessment Factors for Evaluating the Quality of Scie ntific and Technical Information , EPA 100/B-03/001. June,
2003.

OMB, 2002. U.S. Office of Management and Budget. Guidelines for Ensuring and Maximizing the Quality, Objectivity, Utility , and Integrity of Information Di sseminated by Federal Agencies (67 FR 8452).Appendix A

304M PROJECT FILE MANAGEMENT PLAN

# 304m Project File Management Plan

Prepared for:



## U.S. Environmental Protection Agency Engineering and Analysis Division Office of Water 1200 Pennsylvania Avenue, NW Washington, D.C. 20460

Prepared by:



### Eastern Research Group, Inc. 14555 Avion Parkway Suite 200 Chantilly, VA 20151

24 March 2003 Revised 05 March 2004 Revised 01 December 2004 Revised 30 March 2006 Revised 18 July 2006 Revised 30 April 2007 Revised 7 March 2008 Revised 15 August 2008 Revised 19 December 2008 Revised 26 June 2009

EPA Contract No. 68-C02-095 Work Assignment 6-05

### USE AND DISCLOSURE OF DATA

The data contained herein must be treated as privileged and confiden tial. As such, the contents of this document shall not be duplicated, used, or disclosed in whole or in part without the permission of Eastern Research Group, Inc. for any purpose other than to evaluate this project file management plan. The entire contents of this plan are subject to this restriction.i TABLE OF CONTENTS

Page

1.0 INTRODUCTION AND DEFINITIONS .............................................................................1-1 1.1 Background ................................................................................................................ ..1-1 1.2 304m Project File.......................................................................................................... ...1-2
1.3 Docket ..................................................................................................................1 -3 1.4 Federal Docket Management System (FDMS)................................................................1-3 1.5 Electronic Project File.................................................................................................... ..1-4
1.6 Contract File ............................................................................................................. .....1-4
1.7 Personal Files ............................................................................................................ ......1-4 1.8 Project File Index......................................................................................................... ....1-4
1.9 FDMS Metadata.............................................................................................................. .1-4 1.10 Confidential Business Information (CBI)........................................................................1-5
1.11 CBI-Deducible Information.............................................................................................1-5

2.0 G ENERAL P ROCEDURES ....................................................................................................2-1 2.1 Submitting Material to the Project File............................................................................2-1 2.1.1 Step-By-Step Process for Submitti ng Project File Materials...........................................2-1
2.1.2 Detailed Discussion of Document Submission Process...................................................2-9 2.2 Document Control Numbers (DCNs) ............................................................................2-11 2.2.1 Appendices........................................................................................2-11 2.2.2 Copies............................. ......................................................................................2-11
2.2.3 CBI Documents........................................................................................................2-11 2.3 Project File Index......................................................................................................... ..2-11
2.3.1 Index Structure.........................................................................................................2-11

3.0 Q UALITY C ONTROL P ROCEDURES .....................................................................................3-1 3.1 Responsibilities........................................................................................................... .....3-1 3.2 Project File Quality Review Procedures..........................................................................3-1 3.2.1 Project File Index........................................................................................................3-2 3.2.2 Project File and Filing Review ........................................................................................3-2 3.2.3 Project File Revision Plan..... ..........................................................................................3 -3

4.0 D OCKET A SSEMBLY ..........................................................................................................4-1

Attachment 1 PROJECT FILE OUTLINE
Attachment 2 304m PROJ ECT FILE LOG-IN FORM
Attachment 3 FDMS GUIDELINES FOR FREE TEXT FIELDS1-1 1.0 

### I NTRODUCTION AND 

### D EFINITIONS

This document is a plan for the preparation of the project file for EPA’s evaluation of categories of industrial dischargers for pot ential national regulations. ERG is supporting this work through a series of work assignm ents on the National Strategy contract (EPA Contract No. 68-C02-095). Because EPA’s ac tivities are, in part, required by Clean Water Act Section 304(m), the project files are referred to as the 304m project files. This project file management plan is a living document and will be revised and reissued, as necessary. This plan includes definitions and procedures so that all 304m project team members will have the same understanding of our file system. The definitions and procedures are project-specific and may di ffer from terms used for other regulatory development work.

All project file materials will be managed according to ERG’s EPA-approved Confidential Business Information (CBI) security plan that describe s the procedures we
will use to handle CBI on this contract. A ll 304m team members will be trained and tested in CBI procedures before they are permitted to access CBI.

1.1 Background

ERG is supporting EPA in the development and implementation of a strategy for National Clean Water Industrial Regulations. This National Strategy sets out how EPA will fulfill the responsibilities of Section 304(m) and Section 304(g) of the Clean Water
Act. The 1972 Clean Water Act directs EPA to develop national regulations placing limits on the pollutants that are discharged by categories of industry to rivers and streams (termed “effluent guidelines”) or to sewage treatment plants 1 (termed “pretreatment standards”). The Act also directs EPA to de velop national regulations for new industrial facilities (termed “n ew source performance standards”).

An additional critical component of the Act is that it requires EPA to periodically study and review existing effluent guidelines, pretreatment standards, and new source performance standards and consider the need to develop regulati ons for industries not covered by a national regulation. These pl anning requirements are found in several sections of the Clean Water Act (CWA). Section 304(m) provides for an effluent guidelines plan to be published on February 4, 1987 and biennially thereafter. Each effluent limitations guidelines (ELG) pl an contains three basic elements.

First, EPA must establish a schedule for the an nual review of existing effluent guidelines promulgated under Section 304(b) (i.e., limitations for existing direct dischargers) and for revision of the guidelines if appropriate (see Section 304(m)(1)(A )). Second, EPA must identify categories of sources that directly discharge toxi c or non-conventional pollutants for which EPA has not published effluent limitations guidelines or new source performance standards (see S ection 304(m)(1)(B)). Third, EP A must establish a schedule for the establishment of national regulations for any categories identified in the second step, with a promulgated regulation after id entification in a national plan (see Section 304(m)(1)(C)).

1 Also referred to as publicly owned treatment works or POTWs.1-2 For indirect dischargers, S ection 304(g) requires EPA to revi ew at least annually and, if appropriate, revise the pretre atment standards EPA has prom ulgated under Section 307 of the Clean Water Act. In addition, Section 307(c ) provides that pretre atment standards are
to be established at the same time as effluent guidelines for a given industry.

ERG will support the Agency in conducting its annual reviews, developing its biennial ELG plans, and conducting related studies of ca tegories of wastewater dischargers. Some of these studies may result in EPA’s selecti on of that category for further action. These actions may include rulemaking efforts, voluntary programs, and/or further study.

ERG’s support includes collec ting information from exis ting databases, technical publications, and other sources. ERG w ill also support EPA by analyzing this information. The documents, references, and other materials assembled by ERG comprise the 304m project file.

One of EPA’s overarching goals for this work is to provide transp arent decision-making.
This means that the information EPA uses to develop the biennial ELG plans, choose categories for review, and select appropriate fu rther actions, will be made available to the public (with the exceptio n of Confidential Business Inform ation, discussed later in this plan). As EPA announces its actions in the Federal Register , ERG will support EPA in preparing an official docket for the ac tion from the materials assembled in the 304m project file (see Section 4).

1.2 304m Project File

The 304m project file will co ntain items that are collect ed or developed during the support of EPA’s annual reviews, category re views, detailed st udies and ELG plan development. These items may include:

 Meeting minutes;

 Summaries and transcripts of public meetings and hearings;

 Records of communications with partie s outside of EPA, including telephone calls, memoranda, and letters;

 Public statements made by EPA employ ees in their official capacities;

 Public comments, including written opini ons, data, and other information;

 Items submitted to EPA that agree, disagr ee, and/or suggest alternatives to the proposed action; and

 Bibliographies of materials to possibly add to the 304m Docket.

The project file may also c ontain certain material that would not be appropriate for inclusion in public dockets, such as:

 Internal briefing packages;

 “Deliberative” items, including memora nda from ERG to EPA that present regulatory alternatives;1-3  Drafts of Site Visit Reports and Sampling Episode Reports with affected facility review comments (where only the final ve rsion is placed in the public docket);

 EPA Work Group briefing materials and reports;

 EPA management briefing materials;

 EPA internal transmittal memoranda for the rulemaking package;

 Other internal EPA communications; and

 Memoranda from ERG to EPA that set out the pros and cons of various technical approaches if they are deliberative in nature.

The project file should not c ontain contractual materials:

 ERG’s contracts with EPA or our subcontractors;

 Work assignments, work pl ans, monthly reports, etc.;

 Contract performance evaluations; and

 Any other material relating to th e contract between ERG and EPA.

All items in the 304m project file will be assigned an ERG document control number (DCN) for document management purposes. Do cuments that become part of an EPA docket will be assigned an additional document number through the Federal Docket Management System (FDMS). See Section 2.2 for more information.

1.3 Docket

An official docket serves as the repository for the collection of documents or information related to a particular agency action or activity. The official docket generally consists of the documents specifically referenced in the Federal Register notices, any public comments received, and other information used by decision-makers, or otherwise related to the Agency action or activity. Agencies most commonly use dockets for regulatory actions, but dockets may also be used for va rious other non-rulemaking activities, such as Federal Register notices seeking public comments on draft guidance, policy statements, information collection requests under the Pa perwork Reduction Act, and other non-rule activities. Each time an Agen cy action is announced in the Federal Register , a docket is established and assigned a tracking number to accumulate materials throughout the development process.

Multiple dockets will be created from the 304m project file. As project file documents are identified for inclusion in a specific docke t, they will be assigned Docket Numbers.

1.4 Federal Docket Management System (FDMS)

FDMS is designed for use by over a hundred fede ral agencies and entities. FDMS is built on a document management system platform and has Internet access for both public users and agency personnel. FDMS is used to es tablish the public docket, index the docket contents, and to the extent f easible, provide the electronic ve rsion of publicly available docket materials. On November 28, 2005 FDMS replaced EDocket as EPA’s docketing system. The public interface with FDMS can be accessed at http ://www.regulations.gov.1-4 1.5 Electronic Project File

The electronic project file is the network ar ea in which ERG stores the electronic version of items in the 304m project file. These file s are named by DCN. Electronic versions of any CBI items in the 304m project file will be stored in 304(m) area on the CBI server.

1.6 Contract File

The contract file contains materials specifi c to ERG’s management of the contract with EPA. These materials would not be passed on to a succeeding contractor and would be retained by ERG at the conclusion of the c ontract. The contract file contains the following:

 The contract;

 Work assignments;

 Work plans and cost estimates;

 Contract and task instructions;

 Weekly and monthly reports;

 Invoices;

 Contract performance evaluations;

 Project wrap-up meeting notes and reports;

 ERG document review sign-off sheets (com pleted for all project deliverables);
and

 Correspondence with the EPA Contracting Officer.

Items in the ERG contract file are filed sepa rately from the 304m pr oject file and are not assigned DCNs.

1.7 Personal Files

Personal files include project team member not es that are not necessarily interpretable by others, as well as copies of non-CBI materials th at are referred to frequently. Copies will be minimized to keep file space requirements under control. Working drafts of CBI and CBI computer files are managed according to ERG’s CBI Plan.

1.8 Project File Index

The project file index is a lis ting of all documents in the 304m project file. The index is a computerized database that allows for sorti ng and searching the project file by key word, section, date, DCN, docket number, etc. The project file index lis ts all documents, CBI
and non-CBI. Index entries should not contai n CBI information. The index includes a field that designates the CBI status of each item. See Section 2.3 for more details on the project file index.

1.9 FDMS Metadata

Metadata are descriptive information about th e elements of a set of data. For FDMS the
“elements” are documents and the “set of dat a” is the docket. Thus, FDMS metadata are1-5 information that describes each document in a docket. FDMS metadata are similar to the information contained in the project file index, and include among other information, the title, abstract, author, author da te, source citation and page count.

1.10 Confidential Business Information (CBI)

At the time a business or trade association s upplies information to EPA, they may assert a business confidentiality claim covering all or part of the information. If no such claim accompanies the information, EPA may make it available to the public without further notice to the business. If EPA receives a reque st from an outside party for information claimed confidential, it will determine if th e information is entitled to confidential treatment (see 40 CFR Part 2). Please refer to ERG’s Security Plan for Handling Confidential Business Informa tion Under the Clean Water Act , dated March 2004, for further information on handling CBI.

As specified in ERG’s CBI Plan, documents containing CBI will be stored in a designated locked archive or file cabinet. Electronic files containing CBI will be stored on ERG’s separate, limited-access CBI server.

Documents containing CBI will be sanitized prior to their placement in the public docket. The original non-sanitized version of the document will be maintained as a CBI
document.

1.11 CBI-Deducible Information

CBI-deducible information is information th at is not CBI, but when used in conjunction with other publicly-available materials, can be used to deduce CBI. Examples of documents containing CBI-deducible informa tion include pre-test questionnaires and non-CBI screener questionnaires which contain both facility identifier information (e.g., facility name, address, contact s, etc.) and facility codes. To prevent the deduction of CBI, documents containing CBI-deducible information will be sanitized prior to their placement in the public docket. The sanitizati on step will be designed to remove the
information that allows CBI to be deduced. The original non-sani tized version of the
document will be maintained as a CBI document.2-1 2.0 G ENERAL P ROCEDURES

All 304m project file items (i.e., excluding ER G contract file items) will be recorded in the project file index and assi gned a unique DCN (discussed in section 2.2). Project file
items are those items and materials which are defined in Section 1.2 of this project file plan. Team members will submit items that are ready to be entered into the project file, using the steps detailed furthe r in this section, to the ER G staff member with primary responsibility for the project file index (the index keeper). The index keeper will issue DCNs as individual documents are generated and submitted to her.

The outline for the project file, which specifies project file sections, is included as Attachment 1 to this plan. The project file outline will be modified as needed during the performance of this work. Except for CBI docum ents, project file materials will be stored in the 304m electronic project file on ERG’s network. The el ectronic project file will
include folders for each EPA docket that the 304m project file supports. The electronic project file will contain a separate folder (label ed “project file”) for materials that are not part of a docket.

As ERG is directed by EPA to assemble a docket supporting an Agency action, a subset of the items included in the 304m project file will be identified for inclusion in that docket. The appropriate docket num ber will be added to the proj ect file index database to identify these items. Electronic files of thes e documents will be moved from the project
file folder to the a ppropriate docket folder.

If any items identified for inclusion in the docket contain CBI or CBI-deducible information, a sanitized version of the item will be prepared. If CBI is removed from a
document to create a “sanitized” version of the document, that document will receive a
new DCN. The “sanitized” version of the document will be designated with a non-CBI
cover sheet and noted “saniti zed version.” In some cases it may be impossible to produce
a sanitized version of the document. In these cases, the document will be described in the
index and the CBI document will be stored on the CBI server.

2.1 Submitting Material to the Project File

This section presents the processes to be used to submit materials to the Project File, first as step-by-step procedures (Section 2.1.1) then in a more detailed discussion of the submission process (Section 2.1.2)

2.1.1 Step-By-Step Process for Submit ting Project File Materials

Documents will be submitted to the project file following the steps below:

1. If the document is in a format that ca n easily be converted to a PDF (e.g., Word document, Web site, Visio diagram, email) , convert the document to PDF. If the document is hard copy, either scan the documen t in as a pdf or request assistance from ERG docket staff for scanning support.2-2 2. Complete an electronic project file log-in fo rm (see Attachment 1) using the instructions
below.

• DCN : Leave this entry blank; the index keeper will assign this number. For logging in placeholder documents, put the DCN of the placeholder. For logging in attachments to a document, put MAIN in the DCN for the main document, and A1, A2, A3, etc. for the attachments to the document.

 Placeholder (Y or N): If the document is not finalized and the metadata was entered to get a DCN for references, enter TRUE. If the document is finalized,
enter FALSE.

 Title : This should be the full title of the article, study, or report, limited to 400 characters. For memoranda, letters, a nd e-mail correspondence, use the format:

 Memorandum to Angela Beard, Vice President, Medical Research Department, Flonasd Corporation: Subject Subject ;

 Letter to Susan Clark, Citizen: Subject Subject ; or

 Email to John Wright, Cont ractor, Viztronix: Subject Subject

.

For records of telephone conversations (only in formal; formal telephone conversations (e.g., conference call notes) are written as memoranda), use the
format:

 Notes from telephone conversation between John Smith, ERG and Jane Doe, XYZ Corporation, August 6, 2001: Subject Subject

.

For permits, fact sheets, and perm it applications, use the format:

 NPDES Permit: CF Industries, Inc., Donaldsonville, Louisiana;

 NPDES Permit Fact Sheet: CF Industries, Inc., Donaldsonville, Louisiana;

or

 NPDES Permit Application: CF I ndustries, Inc., Donaldsonville,
Louisiana.

For CBI documents, use the format:

 CBI Document Title

.

For Placeholder submittals, use the format:

 PLACHOLDER: Document Title

.

 Abstract : This field is used to provide a dditional description of the individual document. It may be the continuation of a lengthy title. The subject of a memorandum, email, or letter should be en tered as the abstract. Be descriptive; do not simply repeat information that is c ontained in the title. For permits, fact2-3 sheets, and permit applications, the abstra ct should be the NPDES permit number.
Abstracts are limited to 500 characters.

 Document Sub-type: This is the type of document. Choose from the following types.

Sub-Type Description Analysis A review and summation of data or facts which might be used in a report and/or study or which might serve as the basis of an audit, assessment, or
evaluation. Comment Response Agency responses to public comments. Data Facts and figures used to support a position or for the modeling or forecasting of outcomes. Typically thes e records are provided electronically as data dumps on alternative media or as listings or spreadsheets. Economic Analysis A review and summation of economic data or facts. Fact/Data Sheet This subtype includes Materi al Safety Data Sheets (MSDS). Formalized information regarding a particular event, chemical, product, or other used as a tool to disseminate knowledge in a standardized factual manner. Broad
announcements of events or informati on might otherwise be classified as "Press Releases, Public Announcements, Public Notices." Federal Register
Document A draft or formal document published or to be published in the Federal Register which is used as a supporting document as opposed to authorizing a comment period or other action. Form Any government form not specific elsewhere or not part of a larger subtype category such as audit forms which should be classified under "Audit, Assessment, Evaluation." Guidance, Interpretation, Policy,
Procedure Documents which provide direction to Agency employees, contractors, or the public including Standard Operating Procedures, methodologies, and guidelines. Documents which alert others to events used primarily to distribute broad knowledge in a standardized manner. ICR Supporting
Statement The supporting statement wh ich accompanies an ICR.

Index A listing of materials or cross-re ference of sources or citations in a publication, report or study. Interagency Review Draft materials reviewed by outside entities which show signs of being edited including redline/strikeouts. Do not include specific OMB reviews of documents in this category. See "Offi ce of Management and Budget" below. Letter, Memorandum,
Email Correspondence both internal and external to the Agency.

Map A stand-alone map not included in the body of a report, study, presentation,

etc. Meeting or
Teleconference
Materials Telephone contact reports, meeting minut es, and materials used to schedule, inform, conduct or summarize a meeti ng, teleconference, or less formal telephone call including but not limited to: agenda, presentations/handouts/slides, and attendee lists/sign-in sheets. Office of Management and Budget (OMB) Correspondence to and from and drafts reviewed by speci fically by OMB.

Other Non-copyright protected web pages. Permit, Registration A form which registers or perm its the holder to perform a certain action or to use a specific chemical (e.g ., NPDES discharge permit). Physical Item Any item which is considered a record under the NARA definition but which
cannot be otherwise classified as a docum ent or be imported as an image into the system such as a brick, paper plate, or bag. Press Release, Public
Announcement/Notice Documents which alert others to events used primarily to distribute broad knowledge in a stan dardized manner.2-4 Sub-Type Description Public Hearing Transcript, Deposition, Testimony Documents that reflect the words spoken during a legal or administrative law proceeding or interview, typica lly created by a court reporter.

Publication; Copyrighted Material Any non-governmental work which appears to be afforded US copyright protection including journal or magazine articles, abstracts, books or any portion thereof, newspaper articles, on line/trade articles, online news wires or services including MSN.com or CNN.com Publication; Other
Governmental Federal/state/local government publication other than EPA publications.

Publication; USEPA USEPA publication; incl ude an EPA Publication Number in the title. Report A statement of fact and findings usually formalized. This subtype includes status reports on projects or contracts as well as outcomes and findings from the analysis, audit, review or study of processes or procedures whether
scientific or business in function. Signed Federal Register
Document Document authorizing the submission to and release of a Federal Register by
NARA Speech Presentation or transcript of a speech Study A study is a compilation of analysis, data, multiple assessment or audits to ascertain the strength, accuracy or ou tcome of a position or methodology. Studies differ from reports in that a study offers more detailed scientific data, facts or figures from a variety of sources.

Test Data

• Author Name: Name of the individual who authored, edited, compiled or wrote the memorandum, report, study, article, or book. Author Name is limited to 25 characters. For documents with multiple authors, use the format: Bartram, Deborah, et. al.

• Author Affiliation : The affiliation of the author. For documents written by ERG staff, use the format: Eastern Research Group, Inc. For documents written by EPA staff, use the format: U.S. EPA.

• Author Date: Enter as MM/DD/YYYY. Provide th e date of publication, issue, edition, or version. Letters and memoranda usually bear a date in their respective headings. Reports, reviews, and studies us ually have a date located within their respective forwards. Publica tions bear copyright dates. For meeting and telephone notes provide the date of the actual event. If only the month and year are known, enter the first day of th e month. For example: use 05/01/2002 rather than 05/2002.

• Page Count: Enter the total number of pages of the PDF. If the document was not converted to PDF (e.g., Excel file or A ccess database), leave the page count blank. Page Count is lim ited to five characters.

• Category/Industry: If the document pertains to an existing ELG, provide the category name from the drop down menu. If the document pertains to an industry without existing ELGs, provi de the industry name from the drop down menu. If the industry name is not in the drop down menu, type in the name. If the document is not industry-specific, leave this field blank (e.g., Technical Support Document).2-5 • Copyright Protected (Y or N): If the document is copyrighted, enter TRUE, and make sure the document sub-type is “Pub lication; Copyrighted Material.” If the document is not copyrighted, enter FALSE.

• Source Citation: For copyright protected materi al, enter the bibliographic citation, excluding the title, author name, and date because those are included in
other fields. Source citations are limite d to 150 characters. If the copyrighted document is a Web site, use the format:

 Internet Materials: < WEBSITE >. (Accessed DATE ).

If the website is above format is longer than 150 characters, just put the website. If the copyrighted document is a journal article, use the format:

 Journal Article: Natu re 393(2002):639-40; or

 Article in Electronic Journal: JA MA. 287, no. 5 (2001), http:/jama.amaassn.org/issues/v287n5/rfull/joc10108.html (accessed January 7, 2002).

See the ERG Style Guide, Appendix C (available under tools on the ERG Intranet) for additional bibliographic formats.

• Confidential Business Information (Y or N): If the document contains CBI or is CBI-deducible, enter TRUE, and make sure “CBI” is at the beginning of the title.
If the entire document is non-confidentia l or has been sani tized, enter FALSE.

• NPDES Permit ID Number: If the information in the document is specific to a single facility, enter the facility’s NPDE S permit ID. This is typically for notes from a telephone conversations, permits, permit fact sheets, permit applications, or facility websites. If the facility’s NPDES permit ID is not readily available,
leave this field blank.

• TRI ID Number: If the information in the document is specific to a single facility, enter the f acility’s TRI ID. This is typica lly for notes from a telephone conversation, sampling data, or facility we bsites. If the facility ’s TRI ID is not readily available, leave this field blank.

• Keyword 1 and Keyword 2: Enter keywords about the document that could be used to search the index for specific documents. Do not repeat information in other index fields (e.g., title, abstract, NPDES pe rmit ID, or TRI ID).

• Electronic Copy File Location: Copy the full file path, including document title, into this field. For example: Q:\304m\ 2008 Annual Review and Final Plan\Final Reports - Formatted\2008 TSD\ 2008 TSD.2008.09.04 - Draft Final Version formatted 508.pdf. Identify if the item is stored on the CBI network by putting “CBI” in front of the file path.

• Docket Item (Y or N): If the document is for the docket, enter TRUE; if the document is for the project file only, enter FALSE.2-6 • Project File Section Number: Enter the project file section number for the subject outline of the 304m proj ect file (see Attachment 1).

• Submitter Name: Enter your name. If a projec t assistant is entering the information for you, have them enter your name.

3. Submit the log-in form and documents to the index keeper. If you have:

• A non-CBI electronic file, email the file and the log-in form to 304m_record@erg.com . Be sure to include the filename and path to the network area on the log-in form.

• A CBI electronic file, email only the log-in form to 304m_record@erg.com . Be sure to include the filename and path to the CBI network area on the log-in
form.

• A hard copy item that cannot be scanne d (such as a large map or a physical specimen):

 Email the log-in form to 304m_record@erg.com and indicate in the message that the document is not electronic; and

 Print out the log-in form, attach it to the item, and put the item with the log-in form in the 304m project file inbox (in Teresa’s office).

• A database or other file th at must be saved to cd in stead of being uploaded:

 Email the log-in form to 304m_record@erg.com and indicate in the message that the document will be provided on CD or DVD; and

 Print out the log-in form, make two c opies of the CD or DVD, attach the log-in form to the disks, and place th em in the 304m project file inbox (in Teresa’s office).

Adding the Document to the R ecord and Electronic Project File

The index keeper, or designee, will check the 304m_record@erg.com email box weekly
to determine if documents have been subm itted for login. The index keeper will add the documents to the record index on a bi-weekly basis during slow periods (less than 10 items per week) and weekly during high paced periods (more than 10 items per week).

4. The index keeper will import the log-in file into the record inde x and append it to the 304m Index table using the steps outlined in Attachment 2. The index keeper will also update the following fields when the log-in file is appended to the 304m Index table:

• EPA Docket 2010: This field indicates that th e document was identified as Docket Item ‘Y’ and will be placed in the docket for the 2010 ELG Plan. Enter “EPA-HQ-OW-2008-0517.” Documents that ar e identified as Docket Item ‘N’
will have blank fields in this column.

• Input Date: The date the index keeper added the item to the index.2-7 • Metadata Checked (Y or N): This field indicates if the metadata has been
checked. All documents added to the 304m Index will have ‘N’ in this column.

• File Checked (Y or N): This field indicates if the file in the electronic project file
areas has been checked. All documents a dded to the 304m Index will have ‘N’ in
this column.

• Metadata Approved (Y or N) : This field indicates if the metadata has been approved for upload to FDMS. All documen ts added to the 304m Index will have
‘N’ in this column.

5. The index keeper will compare the imported table to the updated 304m Index to make sure the information was added correctly.

6. The index keeper will save the documents to the designated electronic project file areas.

• If the item is not CBI and:

 Not copyright protected, the index keeper will save the document as dcn.pdf to: non-CBI network Q:\304m\Record\Electronic Project File (with appropriate subfolder).

 Copyright protected, the index keeper will save the document as dcn.pdf to: non-CBI network Q:\304m\Reco rd\Electronic Project File.

 Hardcopy, the index keeper will scan the document and save it to the respective electronic project file area.

• If the item is CBI, the index keeper w ill use the Electronic Copy File Location to save the document to the proper pr oject-related area on the CBI network (either p:CBI\304m, p:CBI\steam\, or other).

7. The index keeper will email the submitter the DCNs to the documents they submitted when they are added to the 304m Index.2-8 QA Process for Metadata, Document, and Upload to FDMS

The index keeper will generate qua rterly reports and provide them to the appropriate project file section leads to review the metadata. The repor ts will include at least the following fields
from 304m Index:

• DCN;

• Placeholder;

• Title;

• Abstract;

• Document Sub-Type;

• Author;

• Category Industry;

• Copyright Protected;

• CBI;

• Docket Item;

• Project File Section Number;

• Metadata Checked;

• File Checked; and

• Metadata Approved.

1. The project file section leads wi ll review the metadata and id entify any changes for the index keeper to make. The project file section lead will change the Metada ta Checked field from
‘N’ to ‘Y’ for metadata th at do not need changed.

2. The index keeper will update the metadata based on the project file section leads’ comments. The index keeper will update the Metadata Checked field for the metadata that does not need changing to ‘Y.’

3. For a selected quarterly report, repeat st eps 1 through 3 until all the Metadata Checked fields are changed to ‘Y.’

4. The index keeper will perform quarterly audits of the documents iden tified as Placeholder ‘N’ in the electronic project file areas and compare the files to the metadata.

18.1. For documents that match the metadata, the index keeper will update the File Checked field from ‘N’ to ‘Y;’
18.2. For documents that do not match the metada ta or are missing but not identified as
Placeholder ‘N:’
18.2.1. The index keeper will email the proj ect file section lead the DCN and
document title.
18.2.2. The project file section lead will loca te the document and email either the electronic copy file location or document to the index keeper.
18.2.3. The index keeper will update the electronic project file area with the correct document and update the File Checked field from ‘N’ to ‘Y.’

Additional explanation of the subm ission process is provided below.2-9 2.1.2 Detailed Discussion of Do cument Submission Process

Because the official dockets supporting EPA act ions consist, with a few exceptions, of electronic files, you should submit materials to the project file in electronic format as much as possible. In addition to final re ports supporting the EP A action, project file
materials include ERG deliverables and bac kground materials such as telephone contact reports, journal articles, NPDES permits, etc. These materials should be submitted to the project file as they are finalized even if EPA has not determined if they will be part of an
official docket.

As of November 28, 2005 EPA is using th e Federal Docket Management System (FDMS) to store and manage its dockets. FD MS is a web-based database that holds document records (metadata) that describe each document in a docket and electronic copies of the documents. To expedite devel opment and delivery of the docket, the 304m project file will be stored in the 304m electronic project file. Because the FDMSpreferred format for documents is portable data format (pdf), ERG will store project file documents as pdf files in the electronic proj ect file network area. The electronic project file will have read-only access to preserve th e integrity of the project file items. In addition to standard network backups, the index keeper will back up additions to electronic project file on CD or DVD on a regular basis. The DCN will serve as the filename. For example, 00066.pdf will be the electronic version of document 00066. If a DCN is comprised of multiple documents, a folder will be created using the DCN as the folder name, and each document will be availa ble within the folder. The individual files
will not be renamed.

The first step in submitting materials to the project file is to complete an electronic project file log-in form and e-mail it to the i ndex keeper with the item to be added to the project file. The index keeper will add the data from the log-in form to the project file index and assign the item a DCN. The project fi le index is used to complete the FDMS metadata description for the document, so it is essential that the log-in form is completed properly. The index keeper will store project file documents in the electronic project file (electronic form), with a few exceptions described later.

Project deliverables, with de liverable review sign off sheets

. If the item submitted to the project file is a project deliverable, print ou t the project file log-in form and attach printouts of the transmittal e-mail or transm ittal letter and the deliverable review sign-off sheets. After the index keeper assigns a DCN to the document, she will record the DCN
on the cover letter and revi ew sheet and file them in the contract file.

Related materials . Related materials that do not need to be indexed separately can be logged in as one item and give n one DCN. Examples of mate rials that may be included
under one DCN are:

 Materials presented by several pa rticipants in one meeting;

 A series of telecons between two people about one subject;

 Correspondence between two people on one subject; and

 A related series of calculation sheets.2-10 CBI Items. Team members submitting CBI items for the electronic project file must include on the log-in form the full CBI Serv er path and filename for the electronic
version of the item that is to be added to the CBI Server electronic project file. That
electronic version will then be added to the CBI Server electronic pr oject file area and renamed using the DCN.

Electronic Files on compact disk (CD), digital video disk (DVD), or diskette. As noted above, pdf is the FDMS preferred file format. Some docket items, such as databases and large spreadsheets cannot be saved as pdf files. These items will be submitted to the EPA docket on DVD, CD, or diskette. Copies will be stored in the ERG National Strategy archive, similar to hard copy printouts of documents. Simila rly, computer files received on diskettes, CDs, or DVDs will be identified in the project file index in the title field as being on diskette, CD or DVD. Diskettes, CDs, or DVDs will be clearly marked with the item name and DCN and filed in the ERG National Strategy archive in pouches/envelopes attached to the project file item file folder.

Internet Website Material. Because web addresses and web site content may change over
time and become unavailable el ectronically, Internet website materials should be saved as a pdf file (or html file if the team memb er’s computer is not equipped with Adobe
Writer ® ) and printed out. Log-in information should include the URL and date accessed. The index keeper will convert any html files to pdf and add the electr onic version to the electronic project file.

E-mail Correspondence. E-mail correspondence to be added to the project file should be saved as a pdf file and managed like othe r project file documents. DO NOT simply forward the message on to the index keeper.

Copyright Protected Material . Copyright protected material is often part of an official docket. However, these materials cannot be stored in FDMS. FDMS will include the metadata for the copyright protected material, but will not include an electronic copy of the document. ERG will provide electronic copi es of copyright protected material to the docket office via cd or email. The docket staff will produce hard copies of copyright protected materials that will be available in the docket office for public review. For ERG’s project files, copyright protected material will be saved in a separate section of the electronic project file area of the network

Hard-Copy Items. Items that are only available in hard copy format must be converted to an electronic file, typically by scanning and saving the material in pdf format. The team member will provide the hard copy and comple ted log-in form to the index keeper, who will arrange for creation of the electronic vers ion. Exceptions include copyright protected material (e.g., books and other published mate rial) and physical objects (maps, aerial photos, colored charts, etc.).

NPDES Permits . For NPDES permits and permit fact sheets, ERG will use the following
conventions:

 Title is “NPDES Permit: Name of Plant ” or “Draft NPDES Permit: Name of Plant” ; and

 Abstract is the NPDES perm it number (e.g., PAXXXXXXX).2-11 NPDES Permit Fact Sheets . For NPDES permits and permit fact sheets, ERG will use the following conventions:

 Title is “NPDES Permit Fact Sheet: Name of Plant ”; and

 Abstract is the NPDES pe rmit number (e.g., PAXXXXXXX).

2.2 Document Control Numbers (DCNs)

All 304m project file items will be assigne d a unique document control number (DCN). The ERG staff member with primary responsibi lity for the project f ile index (the index keeper) will issue DCNs as individual documen ts are generated and submitted. The index keeper may also issue batches of DCNs to the EPA WAM to assign to materials received or generated at EAD. Each DCN will consist of five digits plus extensions.

2.2.1 Appendices and Attachments

Major appendices and attachments to documen ts, such as the analytical data reports attached to Sampling Episode Reports, will be given the same DCN as the parent
document with an extension added to de signate the appendix. For example, 09289A001 will designate Appendix 1 to document 09289.

2.2.2 Copies

In accordance with ERG’s CBI plan, each in dividual copy of a CBI document will be tracked in a separate electron ic copy log (the CBI copy log) . The copy log tracks the copy numbers, date generated, des tination, and ultimate dispos ition (e.g., returned to ERG, destroyed). The copy number of a CBI document will be incorporated into the DCN as an extension. For example, 09287C1 will designate copy 1 of document 09287. Multiple copies of non-CBI materials will not be tracked or designated.

2.2.3 CBI Documents

CBI documents will be designated in the project file index as a “yes” in the CBI column
of the index. A sanitized version of a CBI document will receive a unique DCN. CBI documents will be stored in a designated, lo cked storage space. CBI electronic files will
be stored on the CBI server. Names of all files containing CBI will begin with CBI (e.g., CBI0661.pdf).

2.3 Project File Index

The project file index will list all project fi le items. The index will be maintained using
Access® 2003 database software. Entries to the index will be made by the index keeper, or her designee. 304m project team members will have read-only access to the index via
the network. The file will be located under Q:\304m\Record\.

2.3.1 Index Structure

The index key fields are listed below with a br ief description of thei r content. The first 16 fields are included on the project file log-in form and will be completed by the document2-12 submitter. These entries are used to comple te the FDMS metadata description of the document, so it is essential that the log-in form entries are consistent with FDMS metadata requirements. Additional index fiel ds are completed by the index keeper as described below. An asterix (*) preceding th e index field name i ndicates that it is included in the FDMS system. 2

Four of the index fields that will be incl uded in FDMS (Document Title, Abstract, Source Citation, Author Name) are free te xt format. However, informa tion should be recorded in a consistent format to ensure easy retrieval. Because the Document Title is a searchable field, it is especially important that it be free of typos and use consistent abbreviations, punctuation, and capitalization. FDMS guidelines for free text fields are presented in
Attachment 3.

FDMS free text fields are si ze limited, in terms of number of characters (including blank spaces). The character count of an index entr y can be checked using tools/word count in
MS Word.

 *Title : This should be the full title of the article, study, or report, limited to 400 characters. For memoranda, letters, a nd e-mail correspondence, use the format:

 Memorandum to Angela Beard, Vice President, Medical Research Department, Flonase Corporation Re: [Insert Subject Line of Memorandum],

 Letter to Susan Clark, Citizen, or

 Email to John Wright, Contractor, Viztronix.

For records of telephone c onversations, use the format:

 Notes from telephone conversation between John Smith, ERG and Jane Doe, XYZ Corporation, August 6, 2001.

When entering the document title into the FDMS metadata field, the ERG index keeper or her designee will add our DCN to the end of the title.

 *Abstract : This field is used to provide a dditional description of the individual document. It may be the con tinuation of a lengthy title. 3 The subject of a memorandum, email, or letter should be en tered as the abstract. Be descriptive; do not simply repeat information that is cont ained in the title. Abstracts are limited to
500 characters.

2 Only two fields are required to upload a document in to FDMS: the document title and document type. However, ERG will include information from all fields listed in this document as part of its record-keeping support to EPA.

3 Docket staff also use the abstract to explain aspects of the document that might otherwise be confusing to the user (for example, if a document file is not included b ecause it is CBI or a duplicate of another document).2-13  *Document Sub-type: This is an FDMS field with a drop-down menu of allowable document subtypes. To exped ite the index keeper ’s entry of FDMS metadata, choose from the following types.2-14 Sub-Type Description Analysis A review and summation of data or facts which might be used in a report and/or study or which might serve as the basis of an audit, assessment, or
evaluation. Comment Response Agency responses to public comments. Data Facts and figures used to support a position or for the modeling or forecasting of outcomes. Typically these records are provided electronically as data dumps on a lternative media or as listings or spreadsheets. Economic Analysis A review and summation of economic data or facts. Fact/Data Sheet This subtype includes Materi al Safety Data Sheets (MSDS). Formalized information regarding a particular event, chemical, product, or other used as a tool to disseminate knowledge in a standardized factual manner. Broad announcements of events or information might otherwise be classified as "Press Releases, Pub lic Announcements, Public Notices." Federal Register
Document A draft or formal document published or to be published in the Federal Register which is used as a supporting document as opposed to authorizing a comment period or other action. Form Any government form not specific elsewhere or not part of a larger subtype category such as audit forms which should be classified under "Audit, Assessment, Evaluation." Guidance, Interpretation, Policy,
Procedure Documents which provide direction to Agency employees, contractors, or the public including Standard Operating Procedures, methodologies, and guidelines. Documents which alert others to events used primarily to distribute broad knowledge in a standardized manner. ICR Supporting
Statement The supporting statement wh ich accompanies an ICR.

Index A listing of materials or cross-re ference of sources or citations in a publication, report or study. Interagency Review Draft materials reviewed by outside entities which show signs of being edited including redline/strikeouts. Do not include specific OMB reviews of documents in this category. See "Office of Management and Budget"
below. Letter, Memorandum,
Email Correspondence both internal and external to the Agency.

Map A stand-alone map not included in the body of a report, study, presentation, etc. Meeting or
Teleconference
Materials Telephone contact reports, meeti ng minutes, and materials used to schedule, inform, conduct or summar ize a meeting, teleconference, or less formal telephone call including but not limited to: agenda, presentations/handouts/slides, and attendee lists/sign-in sheets. Office of Management and Budget (OMB) Correspondence to and from and draf ts reviewed by specifically by
OMB. Other Non-copyright protected web pages. Permit, Registration A form which registers or permits the holder to perform a certain action or to use a specific chemical (e.g., NPDES discharge permit). Physical Item Any item which is considered a record under the NARA definition but which cannot be otherwise classified as a document or be imported as an image into the system such as a brick, paper plate, or bag. Press Release, Public
Announcement/Notice Documents which alert others to events used primarily to distribute broad knowledge in a standardized manner. Public Hearing Transcript, Deposition, Testimony Documents that reflect the words spoken during a legal or administrative law proceeding or interview, typica lly created by a court reporter.2-15 Sub-Type Description Publication; Copyrighted Material Any non-governmental work which appears to be afforded US copyright protection including journal or magazine articles, abstracts, books or any portion thereof, newspaper articles , online/trade articles, online news wires or services including MSN.com or CNN.com Publication; Other
Governmental Federal/state/local government publication other than EPA publications.

Publication; USEPA USEPA publication; incl ude an EPA Publication Number in the title. Report A statement of fact and findin gs usually formalized. This subtype includes status reports on projects or contracts as well as outcomes and findings from the analysis, audit, review or study of processes or procedures whether scientific or business in function. Signed Federal Register Document Document authorizing the submission to and release of a Federal Register by NARA Speech Presentation or transcript of a speech Study A study is a compilation of analysis, data, multiple assessment or audits to ascertain the strength, accuracy or outcome of a position or methodology. Studies differ from reports in that a study offers more detailed scientific data, facts or figures from a variety of sources.

Test Data

• *Source Citation: For copyright protected material, this is a mandatory field. It consists of a bibliographic citation the pub lic can use to identify the document and to locate a copy through alte rnative means such as a reference library. Source citation is an important part of the me tadata for copyright protected documents
because it allows FDMS to li nk back to the paper record.

The source citation does NOT need to include the title or the author name because those metadata are captured elsewher e in the system. The citation should, however, include such standard informati on as the publisher’s name and city, date of publication, editor or comp ilers’ names, and volume or serial numbers. Source
citations are limited to 150 characters.

See the ERG Style Guide, Appendix C (available under tools on the ERG Intranet) for bibliographic formats. Th ree commonly used citations are shown
below:

Journal article: Nature 393(2002):639-40.

Article in electronic journal: Journal of the American Medical Association . 287, no. 5 (2001), http:/jama.ama-assn.or g/issues/v287n5/rfull/joc10108.html (accessed January 7, 2002).

Internet Materials: <www.epa.gov/wate r/residuals/wtrdoc.html>. (Accessed May 17, 1998).

• *Author Name: name of the individual who auth ored, edited, compiled or wrote the memorandum, report, study, article, or book. For documents with multiple authors, list the primary author (e.g., Ba rtram, Deborah, et. al.). Use full names whenever possible. Author Name is limited to 25 characters.2-16 • Author Affiliation: The affiliation of the author. For documents written by ERG staff, use the format: Eastern Resear ch Group, Inc. For documents written by EPA, use the format: U.S. EPA.

• *Author Date: Enter as MM/DD/YYYY. Provide th e date of publication, issue, edition, or version. Letters and memoranda usually bear a date in their respective headings. Reports, reviews, and studies us ually have a date located within their respective forwards. Publica tions bear copyright dates. For meeting and telephone notes provide the date of the actual event. If only the month and year are known, enter the first day of th e month. For example: use 05/01/2002 rather than 05/2002.

• Page Count: Enter the total number of pages of the PDF. If the document is copyrighted, include the page count of the paper document. This is the total page
count so be sure to include all blank pages. Page Count is limited to 5 characters.

• Category/Industry: This entry is specific to the 304m project file index and will
not be included in the FDMS metadata. If the document pertains to an existing ELG category, provide an abbreviate d category name (e.g., OCPSF, pulp and paper). If the document pertains to an industry without existing ELGs, provide the industry name (e.g., tobacco, PBST). If the document is not industry-specific,
leave this field blank.

• *Copyright Protected (Y or N): All project file items will be identified in the project file index as Y (the item is copyright protected) or N (the item is not copyright protected). The document sub-type of copyright protected material is typically “Publication; Copyrighted Material.”

• Confidential Business Information (Y or N): All project file items will be identified in the project file index as Y (a ll or part of the item contains CBI or is CBI-deducible) or N (the entire item is non-confidential).

• NPDES Permit ID Number: This entry is specific to the 304m project file index
and will not be included in the FDMS metadata. Always include the NPDES permit ID number for permits. For inform ation specific to a single facility (e.g., correspondence; telephone contact report) include the NPDES permit ID number
as it is available.

• TRI ID Number: This entry is specific to the 304m project file index and will not be included in the FDMS metadata. For information specific to a single facility (e.g., corresponden ce; telephone contact repor t) include the TRI ID
number as it is available.

• Keyword 1 and Keyword 2: This entry is specific to th e 304m project file index; however, the key words will be included in FDMS metadata in the abstract field. Key words are intended to aid in searchi ng the index for specific documents. Do not repeat information in other index entries. When completing the key word entry line on the log-in form, refer to th e key words in the existing index database
ensure correct and consis tent spelling, abbreviation, and punctuation are used.2-17 • Electronic Copy File Location: This entry is specific to the 304m project file
index and will not be included in the FDMS metadata. This field refers to the
source location of the document on ERG’s network area. Once the document is submitted to the index keeper for addition to the project file, it will be re-saved
with the DCN as the file name and stor ed in the electronic project file. Items
stored on the CBI server should be identifie d as such. They will be stored in the electronic project file on the CBI server.

• Docket Item (Y or N): Project file items will be identified in the project file index as Y (the item is or will be deliver ed to the EPA docket) or N (the item is project file, only, and will not be deliv ered to the EPA docket). The document submitter should complete this field, entering N if they are not certain that the document will be added to a docket. However, the list of items for the docket will be reviewed and approved by EPA before any documents are uploaded to FDMS.

• Project File Section Number: To help locate documents addressing related topics or subjects ERG created a subject outline of the 304m project file (see Attachment 1). Each outline section is numbered. The individual submitting an item to the index keeper for inclusion in the project file will identify the outline
section for the item.

The index keeper adds the following information to the index as they manage the project file.

• Document Control Number (DCN) : This entry is specific to the 304m project file index; however, our DCN will be in cluded in FDMS metadata at the end of the document title. FDMS will assign a separate, unique document ID to every
document added to a docket. The index keeper will use the following convention for assigning DCNs:

 DCN XXXX;

 Attachments to the DCN will be DCN XXXXA001, DCN XXXXA002,

etc.

• Input Date: This field is the date the index keeper adds the item to the index, EDF, and/or Project File archive.

• *EPA Docket Number: This field identifies the docket in which each document was originally placed:

 EPA-HQ-OW-2003-0074 supports the 2004 ELG Plan;  EPA-HQ-OW-2004-0032 supports the 2006 ELG Plan; and  EPA-HQ-OW-2006-0771 supports the 2008 ELG Plan.

EPA will assign additional dockets to support subsequent biennial plans.

• *Date to Docket: This field lists the date the item was delivered to the EPA docket or uploaded to FDMS.2-18 • Placeholder: A field used by the index keeper to track the flow of pre-assigned
DCNs for documents that have not b een finalize to upload into FDMS.

• ERG_Project: This field is no longer actively used. It identifies items supporting
the Petroleum Bulk Stations and Term inals detailed study conducted in 2003-
2004.

• Source: This field is no longer actively use d. It includes information about the source of the item in pre-FDMS format.

• Recipient: This field is no longer actively used. It includes information about the recipient of correspondence. For FDMS, this information is included in the
document title.

• Placeholder: This field indicates if the DCN is being assigned as a placeholder
until a document has been created. For exam ple, report titles and dates may not be complete at the time their DCN is needed for reference. In this case, the index keeper assigns a placeholder DCN. Once the document is complete, the index keeper completes the metadata for th e document and updates the Placeholder
field.3-1 3.0 Q UALITY C ONTROL P ROCEDURES

Only fully legible, complete documents should be added to th e project file, unless specifically noted as a document excerpt. All documents prepared by ERG will be reviewed prior to submission to the project file. This review will be documented on a Deliverable Review Sign-off Sheet. As indi cated on the sign-off sheet, review of all deliverables includes checking and revi ewing for completeness of supporting documentation. Data and calculations will be checked according to the appropriate ERG Standard Operating Procedure. The docu mentation (such as backup calculations, spreadsheets, and telephone cont act reports) will be added to th e project file at the same time as the document. In most cases, a document will be added to the 304m project file
when it is delivered to EPA.

No item will be added to the project file i ndex unless it is available in hard copy to be filed in the archive and/or electronic form for the electronic project file. No changes will be made to section assignments in the inde x unless the project file item is physically refiled. Correct spelling, standard key word s, accepted abbreviations, and consistent format are required to ensure the index can function as a database.

3.1 Responsibilities

The overall responsibility for the quality of the project file and index belongs to the ERG Work Assignment 6-05 Work Assignment Manager (WAM ). The index-keeper is responsible for the quality of the index (i.e., correct spelling, consistent format) and for correct filing of project file materials. E ach team member is responsible for submitting materials to the project file in a timely fash ion and is responsible for completing project file log-in forms when submitting materials.

The 304m technical team member providing th e technical lead for a particular activity will be responsible for project file submitta ls on the activity, including index entries. They will also be responsible for ensuring that this plan is carried out and that materials are submitted to the project file in a timely manner.

Periodically, the ERG WAM will divide the proj ect file into parts and assign each part to
a 304m technical team member for review. In general, the team member providing the technical lead for the activity included in a project file section will be assigned that
section for review.

3.2 Project File Quality Review Procedures

ERG will perform quality assurance/quality cont rol checks on the project file index, hard copy project file, and the electronic projec t file on a periodic basis to ensure completeness and accuracy. ERG will also periodically review this plan for possible
revision.3-2 3.2.1 Project File Index

After the index keeper or their design ee completes a batch of new index entries (approximately 50 entries or fewer), they will print a list of the new entries. The list will be reviewed for spelling and format consiste ncy. Approximately once a quarter, the index keeper will run database queries on th e index to check for the following:

• Errors in the metadata, such as missing fields, duplicate DCNs, duplicate entries, typos, etc.

• Copyright protected material or other restri cted use material that is not marked as such. For example, some site visit re ports contain materials provided by the facility that was visited. The map or other document provided may contain a copyright symbol or a statement that th e document’s use is restricted. In these cases, ERG project team members or EPA staff should obtain permission to make the document public or exclude the prot ected information from the document being uploaded. As another example, web sites are often copyright protecteded, but the registry symbol appears only on the home page. This type of document
should also be marked as copyright protected.

• Non-CBI material that cont ains the word “confidential” in the document. For example, facilities may provide a document to EPA that is not claimed as CBI; however, pages within the document have been marked with the words “For Internal Use Only” or “Confidential – Draft.” In these cases, ERG project team
members or EPA staff shoul d obtain permission to make the document public or
exclude information marked “Confidentia l” from the document being uploaded. This check is important because if a document is uploaded to FDMS containing any indication of confidential or intern al material, the FDMS docket staff will automatically designate it as CBI.

3.2.2 Project File and Filing Review

Review of the project file content and f iling will occur semi-annually. The index keeper will conduct the following checks:

• Prepare a printout of the 304 m project file index that supports the current docket;

• Ensure all items listed in the index are file d in the archive in the section listed in the index;

• Ensure all filed materials in the archive a nd electronic project f ile are listed in the index with complete and accurate information;

• Ensure all deliverable items listed in the monthly reports are indexed and filed in
the archive and electr onic project file; and

• Communicate all discrepancies to the ERG WAM for resolution.3-3 The ERG WAM will divide the index into part s and assign each part to a 304m technical
team member. The technical team revi ewers will conduct the following checks:

• Resolve discrepancies iden tified by the index keeper;

• Ensure all appropriate documents (e.g., de liverables, reference materials, etc.) have been entered into the project file;

• Ensure all back-up materials (i.e., references, calculations, etc.) for each document are indexed and filed;

• Ensure index entries accurately represent the material; and

• Ensure the CBI and copyright status identification in the index and on the
document is accurate and consistent.

When the project file reviews are complete , the team will meet to discuss and resolve discrepancies and to discuss any possible ch anges needed in the project file plan.

3.2.3 Project File Plan Revision

This plan will be reviewed each year afte r the index-keeper and technical team have completed their annual reviews. As necessa ry, the ERG WAM will ensure the plan will
be revised and submitted to EPA for review . All revisions to the plan will be communicated to the ERG team, following approval from EPA.4-1 4.0 D OCKET A SSEMBLY

The 304m project file supports EPA’s bie nnial Effluent Guidelines plans. EPA opens a new docket for each plan. The doc ket numbers are listed in Table 4-1.

Table 4-1. Effluent Guidelines Plans Docket Numbers

Docket Number ELG Plan Year EPA-HQ-OW-2003-0074 2004 EPA-HQ-OW-2004-0032 2006 EPA-HQ-OW-2006-0771 2008 EPA-HQ-OW-2008-0517 2010

EPA opens a docket prior to the publica tion of a preliminary plan. Next, the Federal Register (FR) notice of the preliminary plan a nd supporting documents are added to the docket. Public comments on the preliminary pl an are added next. Finally, documents supporting the final plan, including res ponses to comments, and the Federal Register notice of the final plan are added to complete the docket.

EPA staff is responsible for opening the docket and working with the EPA Docket
staff to create the docket in FDMS. The ERG i ndex keeper (and a few other ERG project team members) has an FDMS user ID and password. EP A/EAD staff (the “docket contact” in FDMS) must grant permission, by FDMS user ID, for ERG staff to access a specific docket. Once access is granted, ERG staff can create documents by en tering metadata and uploading document files. The FDMS web page can be accessed at http://www.fdms.gov ; however, only approved users can upload files and access other FDMS tools. ERG’s Work Assignment Manager and Document
Control Officer have access to FDMS.

EPA Docket staff conducts a series of QC steps on the created documents, eventually identifying the document as “Pending Post.” The document will not be released to the publicly accessible side of FDMS until a date (“docket phase posting date”) specified by the
EPA/EAD docket contact.

ERG can create document records (ent er metadata) without uploading the document files. Once a document file is uploaded, ERG cannot delete it. If the document has not been posted (released to the public), ERG can request the docket staff to de lete the entire record (Document ID, metadata, and document) by movi ng it to an FDMS area called the “sandbox”. If the document has been posted, the docket cannot ch ange or delete a posted entry, but will add the
revised file and insert a comment to the original entry that a revised document has been uploaded with the new assigned FDMS number. Because of these limitations, it is essential that only final documents (no drafts!) be uploaded to FDMS. Ho wever, the document record can be created, and a Document ID assigned, without uploading the document file. Note, ERG can edit document records before public posting.

ERG will identify items from the project file to be included in the docket and designate those items in the record index, as discussed in Section 2.3.1. These items will include references cited in the Federal Register notice and other supporting docu mentation. Periodically during the development of each ELG plan, a prin tout of the index of the suggested docket
materials will be submitted to EPA for re view. Upon approval from EPA, ERG will add documents to the docket using FDMS by comple ting the document metadata and uploading the4-2 pdf files from ERG’s electronic pr oject file. For electronic databa ses and large spreadsheets that can’t be rendered to pdf, ERG will complete the document metadata and obtain an FDMS “Document ID” for the document. ERG will provi de electronic copies of these materials on
removable media labeled with the Document ID number.

All documents will be added to the docket as pdf files, with the following exceptions:

• Copyright protected material. ERG will provide electronic c opies on removable
media of these materials.

• Physical objects (maps, aerial photos, colored charts, etc.).

• Large documents that present an undue bur den for ERG (as contractor to the EPA program office) to scan (determined af ter consultation with EPA/EAD and docket staff).

• Databases and large spreadsheets that cannot be rendered to pdf. ERG will provide copies of these documents on DVD, CD, diskette, or other electronic medium acceptable to the docket.

• Any document containing CBI. ERG will co mplete the FDMS metadata for CBI documents and include the following in the abstract field: “This document
contains Confidential Business Informati on. Please contact the Document Control Officer listed in the Federal Register Notice if access is necessary.” ERG will not provide copies of CBI to the docket.

Below are abbreviated instructions for submitting material to the Docket. The index keeper and other staff will receive more detail ed instructions prior to the use of FDMS.

• FDMS Metadata Entry into the project f ile index, including adding the ERG DCN
at the end of the FDMS document title.

• EPA approves index entries from Access database printout.

• Index keeper retypes (or block/copies) i ndex information as FDMS metadata into
the interface at http://www.fdms.gov , and each document is assigned an FDMS
Document ID. Use the FDMS “create doc ument” wizard for this process.

• Add descriptions to the abst ract of documents that will not be uploaded to FDMS:

 CBI documents,

 Copyright protected publications,

 Databases and large spreadsheets, and

 Other materials as directed by docket staff.

• Assign a second staff person to open the meta data for a subset of the entries and compare the document details to the Acce ss database printout. Any discrepancies will be brought to the attention of the index keeper, who will correct the FDMS4-3 metadata, as appropriate. The ERG work assignment manager and index keeper
will determine the number of entries to review.

• When a DCN is assigned, the pdf file is saved to the q:\ 304m\Record\Electronic Project File\ area. Assign a second staff pe rson to open the pdf files for all entries and compare the pdf to the metadata. A ny discrepancies will be brought to the attention of the index keeper, who will obtain the correct PDF from the ERG WAM or project team me mber, as appropriate.

• Upload electronic files.

– Document files can be added at the same time that the document record is created, or as a separate step.

– Use the “create document” wizard to add files. In general, ERG will not use the “bulk upload” function.

– Upload pdf files from ERG’s elec tronic project file to FDMS.

– The ERG index keeper will notify docket staff in advance of docket
activities.

– As specified by the project, the inde x keeper or her designee will open the uploaded files to confirm they match the metadata.

• Prepare hard copy material for docket submittal, if necessary. The index keeper will try to convert hard copy material into an electronic file, typically by scanning and saving the material in pdf format. If the material cannot be converted, the index keeper will prepare a hard copy for submittal. This is only expected for the following materials:

– Copyright protected publications;

– Databases and large sp readsheets on DVD, CD or diskette;

– Large Books;

– Physical Objects (maps, and aerial photos);and

– Other materials as directed by docket staff.

• Create a document record (metadata) for hard copy material, as described above.
The document record includes the FDMS document ID.

• Create a label for the hard copy material. The label must not obscure any
information. The label should include:

 Docket number;  FDMS Document ID (in pencil);  ERG Section number;  ERG DCN.4-4 • Prepare paper documents as two-sided copies.

• Assemble all copies in FDMS Document ID order.

• Place copies in top tab accordion folders.

• Submit a hard copy list (index) of the docum ents at the time they are delivered.

• Deliver hard copy docket materials by Fed Ex, courier or ERG staff to the following address: EPA Water Docket , EPA-West Room 3334, 1301 Constitution Avenue, Washington, D.C. 20460.Attachment 1

PROJECT FILE OUTLINEA1-1 2009 Annual Review and Preliminary 2010 Effluent Guidelines Pr ogram Plan Docket Subject Outline

Docket OW-2003-0074

The following existing sections include the docke t materials for the 2004 Effluent Guidelines Program Plan.

Docket OW-2003-0074: Background Docume nts (includes TSD and appendices)

Docket OW-2003-0074: Screening Le vel Review (supporting 2004 Plan)

Docket OW-2003-0074: Industry Rankings

Docket OW-2003-0074: Public Comments

Docket EPA-HQ-OW-2004-0032 Docket EPA-HQ-OW-2003-0074 Docket EPA-HQ-OW-2006-0771 Docket EPA-HQ-OW-2008-0517

The following sections will be used to organize the docket and project file materials for the 2006, 2008, and 2010 Effluent Guidelines Program Plans.

5 No entries

6 Federal Register Notices, Ou treach Materials, and Ot her Background Documents

6.1 Previous Dockets, by reference 6.2 Federal Register Notices
6.3 Outreach Efforts 6.4 Technical Support Documents and Appendices

7 Public and Inter-Agency Comments

7.1 Public Co mments on the 2004 Effluent Guidelines Program Plan
7.2 Public Comments on the Preliminary 2006 Efflue nt Guidelines Program Plan
7.3 Public Commen ts on the Final 2006 Effluent Guidelines Program Plan
7.4 Public Comments on the Preliminary 2008 Efflue nt Guidelines Program Plan 7.5 Public Comments on the First CBM ICR (January 2008) 7.6 Public Comments on the first HCI ICR (August 2008)
7.7 Public Commen ts on the Final 2008 Effluent Guidelines Program PlanA1-2 8 CWA §304(g) Review

Review of the pretreatment standards for industr ial point source categories composed entirely or almost entirely of indirect dischargers.

8.1 Food Service Establishments
8.2 Industrial Laundries 8.3 Photo-processing 8.4 Printing and Publishing
8.5 Health Services Industries
8.5.1 Independent and Stand-alon e Medical and Dental Laboratories
8.5.2 Offices and Clinics of Doctors of Medicine
8.5.3 Offices and Clinics of Dentists 8.5.4 Nursing and Personal Care Facilities 8.5.5 Veterinary Care Services 8.5.6 Hospitals and Clinics
8.5.7 Health Services Industries Economic Information 8.6 Independent and Stand-alone Laboratories
8.7 Industrial Container a nd Drum Cleaning (ICDC) 8.8 Tobacco Products Processing 8.9 Correctional Institutions (Prisons)

9 Screening-Level Reviews

Screening-level review of existing guidelines and sta ndards and new categories.

9.1 Analyses of the Toxics Release Inventory Plan, database, QC checks (including telecons) 9.2 Analyses of Pe rmit Compliance System data Plan, ICIS-NPDES Data Plan, database, QC checks (including telecons)
9.3 Other Screeni ng-Level Data Sources NAICS/S IC/Point Source Category
Crosswalks 9.4 Screening-Level Review Reports QA Project Plans for TRI and PCS Analysis, 2005 Screening-Level Analysis Report
Nutrients Memo 9.5 Toxic Weighting Factor DevelopmentA1-3 10 Existing Guidelines and Standards Review

Further review based on National Strategy Factor s, of industries with existing guidelines and standards, prioritized during scre ening-level review. The National St rategy Factors are: 1) human health and environment hazards; 2) technology innovation and proce ss changes; 3) economics; 4) implementation and efficiency considerations.

10.1 Preliminary Review Reports Review of Prioritized Categories of Industrial Dischargers

All existing categories are listed below. Poten tial new subcategories are included with their parent category. If no materials sp ecific to a category are collected, the section will be identified
as “no entries.” Materials collect ed in support of detailed studies are organized in additional sections, following Section 11.

10.2 Aluminum Forming, Part 467 10.3 Aquatic Animal Production Industry, Part 451 10.4 Asbestos Manufacturing, Part 427 10.5 Battery Manufacturing, Part 461 10.6 Centralized Waste Treaters, Part 437 10.7 Canned and Preserved Seafood, Part 408 10.8 Carbon Black Manufacturing, Part 458 10.9 Cement Manufacturing, Part 411 10.10 Coal Mining, Part 434 10.11 Coil Coating, Part 465 10.12 Concentrated Animal Feeding Operations, Part 412 10.13 Copper Forming, Part 468 10.14 Dairy Products Processing, Part 405
10.15 Electrical and El ectronic Components, Part 469 10.16 Electroplating, Part 413 10.17 Explosives, Part 457 10.18 Ferroalloy Manufacturing, Part 424 10.19 Fertilizer Manufacturing, Part 418 10.20 Fruits and Vegetable Processing, Part 407 10.21 Glass Manufacturing, Part 426
10.22 Grain Mills Manufacturing, Part 406 10.23 Gum and Wood Chemicals, Part 454 10.24 Hospitals Part 460 10.25 Ink Formulating, Part 447 10.26 Inorganic Chemicals, Part 415
10.27 Iron and Steel Manufacturing, Part 420 10.28 Landfills, Part 445 10.29 Leather Tanning and Finishing, Part 425 10.30 Meat and Poultry Products, Part 432 10.31 Metal Finishing, Part 433 10.32 Metal Molding and Casting (Foundries), Part 464 10.33 Metal Products and Machinery, Part 438 10.34 Mineral Mining and Processing, Part 436 10.35 Nonferrous Metals Forming and Metal Powders, Part 471A1-4 10.36 Nonferrous Metals Manufacturing, Part 421 10.37 Oil & Gas Extraction, Part 435
10.37.1 Coalbed Methane 10.38 Ore Mining and Dressing, Part 440 10.39 Organic Chemicals, Plastics and Synt hetic Fibers, Part 414 (including Thompson Report response materials) 10.39.1 Chemical Formulating, Packaging and Repackaging 10.39.2 Biodiesel, Ethanol, and Other Biofuels 10.40 Paint Formulating, Part 446 10.41 Paving and Roofing Mate rials (Tars and Asphalt), Part 443
10.42 Pesticide Chemicals Manufacturi ng, Formulation and Repackaging, Part 455 10.43 Petroleum Refining, Part 419 10.43.1 Petroleum Bulk Stations and Terminals (PBST) 10.44 Pharmaceutical Manufacturing, Part 439 10.45 Phosphate Manufacturing, Part 422 10.46 Photographic, Part 459 10.47 Plastic Molding and Forming, Part 463 10.48 Porcelain Enameling, Part 466 10.49 Pulp, Paper, and Paperboard, Part 430 (materials not related to detailed study, e.g., Phase III permit writers support materials) 10.50 Rubber Manufacturing, Part 428 10.51 Soaps and Deterg ents Manufacturing, Part 417
10.52 Steam Electric Power Generation, Part 423 10.53 Sugar Processing, Part 409 10.54 Textile Mills, Part 410 10.55 Timber Products Processing, Part 429 10.56 Transportation Equipment Cleaning, Part 442 10.57 Waste Combustors (Commercial Inci nerators Combusting Hazardous Waste), Part 444

11 Review of Categories Without Existing Guidelines

11.1 Airport Deicing Operations 11.2 Water Supply (Drinking Water Treatment) 11.3 Miscellaneous Foods and Beverages 11.4.1 Distilled and Blended Liquor 11.4.2 Malt Beverages 11.4.3 Soybean Oil Mills 11.4.4 Miscellaneous Foods and Beverages Economic Information 11.4 Liquefied Natural Gas Import Terminals 11.5 Biofuel ManufacturingA1-5 12 Water Pollution Control Technologies, Water Reuse, Water Conservation Include information about pollution prev ention, wastewater tr eatment, and other wastewater pollution control technologies that applies to multiple point source categories. Technologies or case studies th at focus on one category should be included
in the section for the category or detailed study.

12.1 Water Conservation Issues

13 Steam Electric Power Generation Detailed Study

13.1 Study Plans Detailed Study Plan, QA Project Plan 13.2 Industry Profile Includes pollutants of concern/loadings/sources analys es and relevant articles regarding wastewater characterizatio n issues relevant to key questions"
13.2.1 Permit Review
Includes memoranda listi ng relevant facilitie s and permits selected for review, briefing materials/meeting summaries
13.2.2 Pollutant Data Includes monitoring data packages received from plan ts and monitoring database. 13.2.3 Facility Databases and Supporting Documentation Includes facility database, a ny telecons or other notes to clarify facility data, and change forms.
13.3 NPDES Permits
Includes fact sheets and telecons from follow-up calls with permit writers regarding specific permits 13.4 Stakeholder Meeting Material 13.5 Pollution Control Technologies and Their Costs
Includes data/articles collected on control technologies (scrubbers, wastewater systems), including meetings a nd requests with treatment vendors. 13.6 Industry Surveys UWAG Survey 13.7 Detailed Study Reports
13.8 Site Visits 13.8.1 Site Visit Selection Approach
13.8.2 Yates 13.8.3 Wansley
13.8.4 Widows Creek 13.8.5 Conemaugh 13.8.6 Homer City
13.8.7 Pleasant Prairie 13.8.8 Bailly 13.8.9 Big Bend
13.8.10 Seminole 13.8.11 AES Cayuga
13.8.12 Mitchell
13.8.13 Cardinal
13.8.14 Bruce MansfieldA1-6 13.8.15 Roxboro
13.8.16 Belews Creek
13.8.17 Marshall
13.8.18 Mount Storm
13.8.19 Harrison
13.8.20 Mountaineer
13.8.21 Gavin
13.8.22 Clover 13.8.23 CPS Energy/JK Spruce 13.8.24 Fayette Power Project/Sam Seymour
13.8.25 Ghent 13.8.26 Trimble County
13.8.27 Cane Run
13.8.28 Mill Creek
13.8.29 Brandon Shores
13.8.30 Coleman
13.8.31 Gibson
13.8.32 WVPA - Wabash River 13.8.33 Duke Energy - Wabash River
13.8.34 Paradise
13.8.35 Miami Fort

13.9 Sampling 13.9.1 Sampling Program Planning (Generic SAP, cost estimates, methods/SCC coordination, EPRI information and supplementary data) 13.9.2 Episode 6546 13.9.3 Episode 6547 13.9.4 Episode 6548 13.9.5 Episode 6549 13.9.6 Episode 6550 13.9.7 Episode 6551 13.9.8 Episode 6557 13.10 EPA Data Request Development File s (draft and final DR, m eeting notes, EPA and Battelle comments) 13.10.1 Mail List Development (company summaries –econ, company lists, directories) 13.10.2 Responses 13.10.3 Database (dbase development, data entry QC, data element dictionary, tables/queries) 13.11 Technology Options, Costs, and Loads Includes EPA's analyses, documentation, and memoranda related to defining options, estimating facility and industry costs, a nd estimating facility and industry loads.
13.12 Environmental Assessment DocumentationA1-7 14 Tobacco Products Proce ssing Detailed Study (closed as of December 2006)

14.1 Study Plans (Det ailed Study Plan, QA Project Plan) 14.2 Industry Profile (include information on companies and individual plants) 14.3 Site Visits, Sampling and Analys is (include pre-sampling telephone contact reports) 14.4 Pollution Control Technologies and Their Costs 14.5 Detailed Study Reports
14.6 Tobacco Products Economic Information

15 Pulp, Paper, and Paperboard Detailed Study (closed as of December 2006)

15.1 Study Plans (Detailed Study Plan) 15.2 Industry Information Meeting summary, AF&P A disputed loads letter with enclosures, AF&PA minimum monitoring letter with encl osures, Mill discharge data (i.e., minor discharger, Washington mills), Phase I Mill Industry Profile.
Draft TRI Guidance Document, TAPPI paper Comparing Chlorinated Phenolic loadings 15.2.1 Pulp and Paper Industry Economic Information 15.3 Quality Review Designation of SIC codes into Phase, Changes to Phas es, telecons (i.e., Kimberly- Clark Everett WA, Weyerhaeuser surf ace impoundment, IP-Cantonment Permit Status) 15.4 NPDES Permits (Includes fact sheets and communication from mills that defined outfalls) 15.4.1 Phase I mill permits 15.4.2 Phase II mill permits 15.5 Detailed Study Reports

16 Coal Mining Detailed Study

16.1 Study Plans (Detailed Study Plan, QAPP) 16.2 Industry profile for the coal mining industry
16.3 Pollutant loads
Data Obtained from states and IMCC Pollutant Loads Concept Memo Loads spreadsheets and results 16.4 Treatment technologies and costs Model mine memo, AMD Treat review, costing spreadsheets and results
16.5 Environmental assessment Memos addressing “Key questions”
Articles collected related to impacts of manganese 16.6 Flight 93 Memorial Site Information Joanne Hanley e-mails, Lenny Lichvar document, PBS Coals letters 16.7 Non-CWA Regulations (SMCRA, Other Federal, and State Laws) 16.8 Economics, Bonds, and Trust FundsA1-8 17 Health Care Detailed Study

17 Health Care Detailed Study 17.1 Study Plans and Reports 17.2 Dental Hg Industry Profile and Background Information (including wastewater characteristics, regulations, guidance) 17.3 Dental Hg BMPs, Control Technologies, and their Costs 17.4 Dental Hg POTW Treatment Efficiencies, pass th rough, and interferences 17.5 Dental Hg Economic Information 17.6 Dental Hg Meetings
17.7 Unused Pharmaceuticals Indus try Profile and Background Information (including
wastewater characteristic s, regulations, guidance) 17.8 Unused Pharmaceuticals Data Request and Responses 17.9 Unused Pharmaceuticals BMPs, Control Technologies, and their Costs
17.10 Unused Pharmaceuticals POTW Treatment Efficiencies, pass through, and
interferences
17.11 Unused Pharmaceuticals Economic Information 17.12 Unused Pharmaceuticals Meetings and Site Visits

18 Coalbed Methane Detailed Study

18.1 Plans 18.2 Stakeholder Meetings 18.3 Site Visits/Sampling 18.4 Industry Survey Development and Distribution 18.4.1 Questionnaire Development 18.4.2 Survey Sampling Strategy includes development of mailing list
18.4.3 Information Coll ection Request includes burden estimate, drafts of ICRs 18.5 Industry Survey Results 18.5.1 Responses raw completed questionnaires 18.5.2 Database(s) 18.6 Technical Background Information 18.6.1 Produced water quality and volume data
18.6.2 Reuse and Tr eatment Technologies tech nology performance and costs 18.7 Economic Background Information 18.8 Environmental Assessment Background Information 18.9 Detailed Study ReportsA2-1 Attachment 2

304m PROJECT FILE LOG-IN FORMSA2-1This page illustrates the electronic Microsoft Excel spreadsheet, with dropdown menusavailable for auto-population of some fields. The second page shows the alternative loginsheet: a table that can becompleted in eitherMicrosoft Excel or Word.Example Blank Microsoft Excel Login SheetExample of Login Sheet Drop-Down MenuExample Completed Microsoft Excel Login SheetA2-2 

## 304(m) ELECTRONIC PROJECT FILE INDEX LOG-IN SHEET

Submitted by:

DCN: Index Keeper will assign DCN

TITLE:

ABSTRACT:

DOCUMENT_SUB TYPE:

SOURCE_CITATION:

AUTHOR:

AUTHOR_DATE:

PAGE_COUNT:

CATEGORY_INDUSTRY:

COPYRIGHT PROTECTED (Yes or No):

CBI (Yes or No):

NPDES_PERMIT_ID:

TRI_ID_NUMBER:

KEYWORD_1:

KEYWORD_2

ELECTRONIC COPY FILE LOCATION:

DOCKET_ITEM (Yes or No)Attachment 3
FDMS GUIDELINES FOR FREE TEXT FIELDSA4-1 Guidelines for Free Text FDMS Metadata

Information for free text fields should be record ed in a consistent format to ensure reliable
retrieval.

The guidelines described below cover the most co mmon types of errors: grammar, abbreviations, capitalization, use of numerals, and punctuati on. Two additional areas where errors are likely to be generated include spelling and typographical formatting. Use of spell checking software and proofreading ente red data can reduce spelling errors. Typographical or formatting errors can be caused by sloppy cut and paste functions, forgetting to close a parenthetical expressi on, or failing to use quotation marks correctly. These errors can be addressed by using gram mar checking software and, again, carefully proofreading data entry.

Within the FDMS system, the Document ID, Document Title, and Document Type are
searchable fields. The search fields are case se nsitive. Document Title is a free text field, so special care for consistency in capitalizati on must be taken with this field. If the user searches on a term using a mix of upper and lower case letters, the database will only return results that match that specific mix of characters. Searches performed using letters of a single case will return results regardless of specific character combinations. Since users are most likely to use a mix of upper a nd lower case letters with proper names, you
must be sure that the metadata are entere d in the correct format for a proper name.
Guidelines are included below on the use of abbreviations, capitaliz ation, numerals, and punctuation. Additional resources that can be used in making formatting decisions
include dictionaries and the MLA Handbook for Writers of Research Papers , Sixth Edition (2003).

I. Grammar Review

The same careful thought given to writing a memo randum or a letter should be used when composing metadata. Fields such as Abstr act are designed to allow the data entry operator to present information using a nywhere from a single sentence to a full paragraph. It is important, therefore, that th is information be presented in proper syntax using complete sentences. Run-on sentences sh ould be avoided. As with any free text field, it is important that the data be presen ted in a way that other readers will find clear and concise. Since space in the field is limited, you may need to redraf t text to fit within the parameters of the field. When doing so, it is important be sure that all unnecessary
characters have been removed and that the ne w text conforms to the flow of the existing

sentences.

II. Abbreviations

Abbreviation styling is, unfortuna tely, inconsistent and depends most often on the organization’s policy. Company names are especially arbitr ary as many businesses desire a unique look and feel to distinguish their name and letter head from other firms. For example, Gulf + Western Industries, Inc. is the actual company name. This firm selected to represent the
word “and” not with the more traditional “&” but with a posi tive or plus sign “+”. In such cases, you should default to the official name as presented by the organization.A4-2 Abbreviations are used for many reasons in document development. The most common reasons include (1) to avoid repetition of long words and phrases that may di stract the reader, (2) to save space and time, (3) to replace keys trokes and increase output , and (4) to reflect statistical data in limited space. When usi ng an abbreviation that may be unfamiliar or confusing to the reader, one should give the fu ll form first followed by the abbreviation in parentheses as

Summary of Orders from the Offi ce of Management and Budget (OMB).....

followed in subsequent references by just the abbreviation, as

At the June 14, 2003, OMB meeting, agents met to discuss......

When abbreviating an Agency employee’s various program affiliations, it is acceptable to use virgules. For example: Dave Beck, USEPA/ESED/CPB/CM

If a position title had been provided, the proper format would have been: Dave Beck, Regulatory Analyst, USEPA/ESED/CPB/CM

Guidelines for Abbreviations
The only terms which do not require use of the fu ll form before the use of the abbreviation are
those business units within the U.S. Envir onmental Protection Agency or the agency
name itself.

If the full form and abbreviation are used in the docket or document title field, then the abbreviation may stand alone in the dock et or document de scription field.

Guideline Sample
The Environmental Protection Agency should be abbreviated according to Agency
Standard. USEPA

Beginning a sentence wi th an abbreviation
should be avoided unless the abbreviation represents a courtesy title. Page 22 contains.... but not P. 22 contains ....

Dr. Smith is here. or Doctor Smith is here.
Company names are not abbreviated unless abbreviations comprise their official

name. Ginn and Company Harwood Engineering Co., Inc.

Compass points are abbreviated when occurring after street names and they can be unpunctuated. 2122 Apple Street, NW

Geographical and topographical names should
utilize U.S. Postal Service
abbreviations. AL AK MN DC
BLVD ST PL RR US

Laws and bylaws when first mentioned are typed in full; however, subsequent references may be abbreviated. first reference Article I, Section 1 subsequent reference Art. I, Sec. 1A4-3 Guidelines for Abbreviations
Personal names should not be abbreviated. George S. Patterson not Geo. S. Patterson

Scientific terms in binomial nomenclature may have the genus abbreviated after
the first full form reference. first reference Escherichia coli subsequent reference E. coli

Titles that are invariably abbreviated include Mr., Mrs., Ms., Messrs., and Dr.
Honorable and Reverend when used
with The are typed out. If used without
The , these forms of address may be
abbreviated. Colonel COL John P. Howe, USA General GEN John P. Howe, USA Private PVT John P. Howe, USA

Versus is abbreviated as the lowercase Roman
letter v. in legal contexts. In general context, it is abbreviated as vs. Smith v. State of Vermont honesty vs. dishonesty

III. Capitalization

Upper case letters are used for two broad purposes in English: they mark the beginning of a sentence and they signal a proper noun or ad jective. Keeping mind that the database’s search function are case sensitive, it becomes even more critical for you to apply the rules of capitalization accurately.

Guidelines for Capitalization
Abbreviations are only capitalized if the words they re present are proper n ouns or adjectives.
The first word of a sentence, of a sentence fragment, or of a complete sentence enclosed in parentheses is capitalized.

Guideline Sample
Most acronyms are capitalized unless they
have been assimilated into the language as parts of speech.

Consult a dictionary for proper styling. Acronyms that are not part of the daily language: MIRV NOW account

Acronyms that are used as part of the daily language: scuba, quasar, laser, radar, sonar, snafu
Abbreviations of air force, army, coast guard, and navy ranks are all capitalized. Those of the marine corps are capitalized and lower cased. BG John P. Howe, USA LCDR Mary I. Lee, USN Col. John P. Howe, USMC

Abbreviations of academic degrees and professional ratings may be allcapitalized or capitalized and lowercased depending on the term. Consult a dictionary for proper styling. D.D.S. M.B.A.
P.E. C.P.A.
Ph.D.A4-4 Guidelines for Capitalization

Branches and units of the armed forces are capitalized, as are easily recognizable
short forms. United States Army and Army Rangers

Popular names of localities are capitalized. Capitol Hill Foggy Bottom Georgetown the Sunshine State
the Corn Belt the Eastern Shore

Nouns used with numbers or letters to designate major reference headings are capitalized; however, minor reference headings and subheads are typically
lowercased. Book II Volume V Part 1 Table 5 Figure A Appendix III

footnote 14 page 12 line 8 item 16 note 10 paragraph 7
Words in titles of printed matter are capitalized except for internal conjunctions, prepositions, and
articles. Introduction to Word Processing
Before the Fall
Journal of Scientific Medicine

The first word following a colon in a title is capitalized. CBS: Reflections in a Bloodshot Eye Women in Baseball: The Forgotten History

Trademarks, brand names, and service marks are capitalized. the Dell workstation Federal Express
Touch-Tone
The names of ships, airplanes, and spacecraft are capitalized. space shuttle Columbia Spirit of St. Louis
M. V. West Star

IV. Numerals

In modern business writing, most numerals - an d especially exact numbers above 10 - are expressed in figures. Since there is flexibility in expressing monetary units, dates, and other numerical combinations, the overriding consideration is to be consistent in the
standard selected. Provided below are the st andards selected for us e of numerals in the
FDMS database.

Guidelines for Numerals

Guideline Sample
Ages are expressed in figures. Her 11 year-old son... A 65 year-old veteran...
Space permitting, numbers that begin a
sentence are to be written out. Thirty-two birds died.

Dates should be written as Month, Day, and Four Digit Year when expressed in
narrative format. Ordinal numbers
should not be used. January 1, 2003

not the 1 st of January, 2003A4-5 Guidelines for Numerals

Guideline Sample
Dates may be represented in figures when not
in narrative format but must be in the
format of MM/DD/YYYY. 11/21/2003

Exact amounts are usuall y expressed in figures unless they begin a sentence. Thirty-two birds died. Due to the chemical spill, 32 birds died.
Percentages will use the % character. 10 % not 10 percent
Figures over 999 will use a comma except
when the number is a set combination such as a contract number, policy number, check or invoice number,
address or room number. 1,135 keystrokes not 1135 keystrokes

Check 34567 the year 2003 page 4526
Room 6000-B Contract No. W-03-12456

V. Punctuation

The English writing system uses punctuation marks to separate groups of words for meaning and emphasis; to convey an idea of the variations of pitch, volume, paus es, and intonation of speech; and to help avoid contextual ambi guity. Punctuation marks should be used sparingly as special characters can make se arching for and retrieving data difficult.

Spacing is an important issue in the use of speci al characters. There should be no space between the following combinations: any word and the punctuation that closes a sentence, quotation marks and the quoted matter, parenthe ses or brackets and the words or figures that they enclose, between initials co mprising abbreviations , between hyphenated compounds, or on either side of a dash. Th ere should be one space after a comma or semicolon, after a period following an initial in a proper name (Mr. H. C. Milker), before and after mathematical signs, and between U. S. Postal Service state abbreviations and
the ZIP Code.

Guidelines for Punctuation
Virgules (/) are not used to separate items in a list or to divi de phrases but can be used if it is part of a title or acronym. (E.g. OEI/OIAA)
Use of the ampersand (&) should be avoided wh enever possible. Spe ll out the word “and” instead. Use of the ampersand is permissible when it is a part of a proper noun such as a company name or is part of a legal case title or publication title.
Hyphens/dashes (-) are not used to introduce a list of items.
Ellipses (...) are used when a title or quote is to long to fit within a field.

Guideline Sample
While apostrophes normally mark the
omission of numerals or letters, this use
should be avoided in the FDMS database
where the electronic record will be retained indefinitely. the class of 1967 not the class of ‘67

fiscal year 1987 not fiscal year ‘87A4-6 Guidelines for Punctuation
Apostrophes are used in posse ssive nouns. One Man’s Junk

The History of the Thirty Years’ War

Brackets set off extraneous data and function as parentheses within parentheses. The company deceived them [the suspects] and is now paying hefty penalties.

(Bowman Act [also known as the Freedom Act] Ch. 4, sec. 4, p. 50)
Colons introduce a clause or phrase that explains, illustrates, amplifies or restates what has gone on before. The Hazards of Benzene: An Inhalation Study

Colons introduce items in a series. Please reference the following dockets: OAR2002-0012, OAR-1999-0014, and
OW-2001-0142.
Colons separate elements in set formulas such as ratios, time, volume and page references, biblical citations, and place and publisher. a ratio of 3:5 8:30 a.m.
Words and Phrases 11:261 John 4:10 Springfield, MA: Merriam-Webster Inc.

Commas divide items in a list and set off cities from states, dates from years, and lines in an
address. ...includes: OAR-2002-0012, OAR-1999- 0014, and OW-2001-0142. Shreveport, LA December 7, 2003

Hyphens are used only in numerical sets where dictated by style. OAR-2003-0012
Contract No. W-03-125-8954A
Hyphens are used between some prefix and
root combinations.

Consult a dictionary for proper styling. trans-Atlantic flight pre-2003 re-publish
non-road

Hyphens are used in compound words, especially those containing a preposition.

Consult a dictionary for proper styling. chairperson-elect attorney-at-law

Hyphens are used between compound adjectives. light-duty large-scale eight-cylinder
Hyphens are used in expressing written out numbers, between a numerator and denominator, dividing years and pages in a range, or showing a distance relationship. forty-two flowers a two-thirds majority pages 40-67
the decade 1960-1970 US-Iraq relations
Ellipses (...) are used when a title or quote is too long to fit within the field. The organization replied that it “felt overwhelmed by the workload required
under...the Clean Air Act.”A4-7 Guidelines for Punctuation
Alternative spellings of English terms should
be retained in formal ti tles and affiliations. In FDMS, include the Amer ican spelling of the
term in brackets after the foreign language spelling.

Consult your dictiona ry for the proper American spelling. organisation [organization] colour [color] centre [center] glycerine [glycerin]