# Draft Quality Assurance Project Plan for the Plastics Molding and Forming Preliminary Category Review

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

November 2010

EPA Contract No. 68-C-02-095 Work Assignment 8-05i TITLE AND APPROVAL SHEET

Quality Assurance Project Plan for the Pl astics Molding and Forming Preliminary Category Review

Ellie Codding - ERG Work Assignment Manager Date

Mary Willett - ERG Project Quality Assurance Coordinator Date

Damon Highsmith - EPA Technical Project Officer Date

Bill Swietlik - EPA Work Assignment Manager Date

Marion Kelly - EPA/EAD Quality Assurance Coordinator Date

Jan Goodwin - EPA Branch Chief, T echnology and Statistics Branch Dateii TABLE OF CONTENTS

Page

1.0 I NTRODUCTION ..................................................................................................... 1-1

2.0 P ROJECT M ANAGEMENT E LEMENTS ..................................................................... 2-1 2.1 Project Organization (Element A.4) ........................................................ 2-1 2.2 Problem Definition/Background (Element A.5) ...................................... 2-2 2.2.1 Background .................................................................................. 2-2 2.2.2 Statement of Key Questions and Project Objectives ................... 2-3 2.3 Project/Task Description (Element A.6) .................................................. 2-4 2.3.1 Characterization of the Cellulose Products Manufacturing Subcategory.................................................................................. 2-5 2.3.2 Review of Carbon Disulfide Discharges from Cellulose Products Manufacturing Facilities ............................................... 2-6 2.3.3 Identification of Potential Impacts from PMF Wastewater Discharges .................................................................................... 2-6 2.3.4 Review of Technologies Appr opriate for the Treatment of Wastewater Discharges fr om the PMF Category ......................... 2-6 2.4 Quality Objectives and Acceptan ce Criteria (Element A.7) .................... 2-7 2.5 Special Training/Certifica tion (Element A.8) .......................................... 2-8 2.6 Documents and Records (Element A.9) ................................................... 2-8

3.0 D ATA G ENERATION AND A CQUISITION ................................................................. 3-1 3.1 Sampling (Data Collection) Proc ess Design (Element B.1) .................... 3-1 3.2 Sampling (Data Collection) Methods (Element B.2) ............................... 3-1 3.3 Sample (Data) Handling and Custody (Element B.3) .............................. 3-2 3.4 Quality Control (Element B.5) ................................................................. 3-2 3.5 Non-Direct Measurements (Element B.9) ............................................... 3-3 3.6 Data Management (Element B.10) .......................................................... 3-3

4.0 ASSESSMENT AND OVERSIGHT ELEMENTS ............................................. 4-1 4.1 Assessments and Response Actions (Element C.1) ................................ 4-1 4.2 Reports to Management (Element C.2) ................................................... 4-1

5.0 DATA VALIDATION AND USABILITY ELEMENTS .................................... 5-1 5.1 Data Review, Verification, and Va lidation; and Validation Methods (Element D.1 and D.2) ............................................................................. 5-1 5.2 Reconciliation with User Requirements (Element D.3) ......................... 5-1

6.0 R EFERENCES ......................................................................................................... 6-1

Appendix A: ERG STANDARD OPERATING PROCEDURESiii LIST OF TABLES

Page

1-1 QAPP Distribution ............................................................................................... 1-1

2-1 Cellulose Manufacturers in the United States ...................................................... 2-3

2-2 Literature Review Source and Trea tability Data Acceptance Criteria ................. 2-7

2-3 §308 Informal Data Request Data Acceptance Criteria ....................................... 2-8

LIST OF FIGURES

Page

2-1 Project-Level QA Organization for ERG’s Support of the PMF Preliminary Category Review .............................................................................. 2-2Section No. 0 Revision No. 0 Date: 2 November 2010 Page 1 of 2

Distribution (Element A.3)

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

Table 1-1. QAPP Distribution

Name Title Contact Information Mailing Address
U.S. Environmental Protection Agency
Damon Highsmith Technical Project Officer (202) 566-2504 (phone) highsmith.damon@epamail.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 Coordinator (202) 566-1045 (phone) kelly.marion@epamail.epa.gov

Bill Swietlik Work Assignment Manager (202) 566-1129 swietlik.william@epamail.epa.gov
Jan Goodwin, Technical and Statistics Branch Chief (202) 566-1060 goodwin.janet@epamail.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 Project Quality Assurance Coordinator (703) 633-1615 Mary.Willett@erg.com

Ellie Codding Work Assignment Manager (703) 633-1673 Eleanor.Codding@erg.com
Jessica Gray PMF Task Lead (703) 633-1681 (phone) Jessica.Gray@erg.comSection No. 0 Revision No. 0 Date: 2 November 2010 Page 1 of 2

1.0 I NTRODUCTION

The U.S. Environmental Protection Agency (EPA) establishes national technology-based regulations known as effluent limitations guidelines and standards (ELGs) to reduce pollutant discharges from industrial catego ries that discharge directly to waters of the United States. EPA establishes analogous pretre atment standards for discharges to publicly owned treatment works (POTWs). The Clean Wa ter Act (CWA) sections 301(d), 304(b), 304(g), and 307(b) require EPA to annua lly review these regulations.

CWA section 304(b) requires EPA to revi ew its existing effluent limitations guidelines for direct dischargers each year and to revise such re gulations “if appropriate.” CWA section 304(m) supplements the core requirement of section 304(b) by requiring EPA to publish an Effluent Guidelines Program Plan (“Plan ”) every two years announcing its schedule for performing this annual review and its rulemaking schedule for any e ffluent guideline selected for possible revision as a result of that annual review.

EPA’s annual review of existing ELGs, refe rred to as the 304(m ) Program in this document, includes the following three steps:

1. Annual screening-level analysis to prioritize categories.

2. Preliminary review of existing ELGs to address data gaps of prioritized categories and to investigate stakeholder recommendations and comments.

3. Detailed studies of prioritized categories to investigate pollu tant sources and pollutant reduction approaches to determine if EPA should identify any of the prioritized categories fo r possible revision of their existing effluent guidelines and/or pretreatment standards.

This Quality Assurance Project Pl an (QAPP) covers the second st ep, preliminary review, for one prioritized category. Specifically, this QAPP cove rs the analysis of the Cellulose Products Manufacturing Subcategory of th e Plastics Molding and Formi ng (PMF) Point Source Category 1

. Analysis of the Cellulose Products Manufacturin g Subcategory may include the collection of primary data (e.g., facility information, wastew ater treatment information) and the use of secondary data (e.g., existing treatability data, data collected during literatu re searches) to better understand wastewater discharges from the Cellulose Products Manufacturing Subcategory.

Based on currently available informati on, discharges from cellulose products manufacturing facilities may c ontain significant quantities of carbon disulfide and other toxic pollutants. Because cellulose products manufacturi ng is specifically excluded from the Plastics Molding and Forming ELGs (see 40 CFR Part 463), EPA is reviewing these discharges to better understand the potential hazard they pose to human health and the environment, and to determine if the hazard posed by these di scharges warrants regulation by technology-based standards.

1 According to Beach et al. (2000), th e Cellulose Products Manuf acturing Subcategory includ es facilities covered by NAICS codes 32511, 325199,3252, 326121, and 326199.Section No. 0 Revision No. 0 Date: 2 November 2010 Page 2 of 2

As part of the PMF Preliminary Cate gory Review, ERG will collect facility information to characterize the industry, wast ewater treatment information to understand currently used treatment technol ogies, and available literature to identify potential impacts caused by wastewater discharges.

As directed by Work Assignment 8- 05 of Contract No. 68-C-02-095, ERG prepared this detailed QAPP addressing the suppor t we will provide in collecting primary data (e.g., facility information, wastew ater treatment information) and using secondary data (e.g., treatability data, surface water impacts data co llected during literature searches) to better understand cellulose products manufacturing and the PMF Category. This QAPP is responsive to all applicable elements specified in EPA Requirements for Quality Assurance Project Plans (EPA, 2001)

. It is a project-specific supplement to ERG’s Quality Management Plan for Technical Support for the Strate gy for National Clean Water I ndustrial Regulations, June 2002 (EPA, 2002a), which was prepared in accordan ce with EPA Requirements for Quality Management Plans (EPA, 2001b). ERG’s Quality Assurance (QA) coordinators and project management team plan, implement, and assess pr oject quality procedures throughout all project levels. These procedures, tailored to the needs of the tasked activities, will be used on this work assignment.Section No. 2.0 Revision No. 0 Date: 2 November 2010 Page 1 of 9

2.0 P ROJECT M ANAGEMENT E LEMENTS

This section addresses project mana gement, including project history and objectives, roles and responsibilities, and projec t goals. In addition, this section presents the mechanisms ERG will use to ensure that all participants understand the goals and the approach to be used for primary and secondary data collec tion and literature revi ew conducted under the PMF Preliminary Category Review. In its Requirements of Quality Assurance Project Plans (EPA, 2001), EPA identifies nine project manage ment elements. The nine elements are:

 A.1: Title and Approval Sheet;

 A.2: Table of Contents;

 A.3: Distribution List;

 A.4: Project Organization;

 A.5: Problem Definition/Background;

 A.6: Project/Task Description;

 A.7: Quality Objectives;

 A.8: Special Training /Certification; and

 A.9: Project Documents and Records.

Elements A.1, A.2, and A.3 are included at the front of this document. The remaining elements are presented below.

2.1 Project Organization (Element A.4)

Figure 2-1 presents the project organi zation for the PMF Preliminary Category Review. ERG’s WAM will be responsible for ensu ring that the quality of work, schedule, and budget meet the requirements of the PMF Prel iminary Category Review. The ERG WAM will be the principal contact for the EPA WAM a nd EPA PMF Task Lead on project issues, deliverables, and schedule. She will also keep the Project QA Coordinator and the ERG Program Manager advised of any quality problems that arise.

The ERG PMF Review Task Lead will be resp onsible for the data analysis efforts. She will provide technical direction to ERG staff and will be responsible for the daily activities on the project. Additional ERG staff will assist in collecting primary and secondary data and reviewing information to bette r understand wastewater discharg es from the PMF Category. ERG staff will also assist in producing documents repo rting the findings of the data review. The ERG Project QA Coordinator will review this QAPP to confirm it specifies the qu ality required for primary and secondary data collection and analysis activities to be used on the project. The Project QA Coordinator will also confirm that the ERG WAM is obtaining a ppropriate technical review of all documents.Section No. 2.0 Revision No. 0 Date: 2 November 2010 Page 2 of 9

Figure 2-1. Project-Level QA Organization for ERG’s Support of the PMF Preliminary Category Review

2.2 Problem Definition/Background (Element A.5)

This section discusses th e purpose of the PMF Preliminary Category Review and outlines the key questions to be addressed in the analysis of primary and secondary data collected as part of the review.

2.2.1 Background

EPA first identified the PMF Category fo r additional review in the 2006 Final Effluent Guidelines Program Plan due to carbon disulfide discharges reported to PCS and TRI for 2002 (U.S. EPA, 2006). In the 2010 Final Effl uent Guidelines Program Plan, EPA designated the PMF Category for a preliminary category revi ew due to discharges of carbon disulfide and other pollutants (U.S. EPA, 2010). ERG National Strategy Contract QA Coordinator

ERG Project QA Coordinator

Reviewers ERG Program Manager

ERG Work Assignment

Manager

ERG PMF Project Staf f EPA Work Assignment Manager

EPA PMF Task
Lead

EPA QA Coordinator

Lines of Communication Reporting and Authority ERG National Strategy Contract QA Coordinator

ERG Project QA Coordinator

ERG Technical ERG Program Manager

ERG Work Assignment

Manager EPA Work

EPA QA Coordinator

Lines of Communication Reporting and AuthoritySection No. 2.0 Revision No. 0 Date: 2 November 2010 Page 3 of 9

EPA is specifically focusing on cellulo se products manufact uring facilities because their discharges were the top con cern for the PMF Category during the 2010 annual review. According to EPA’s screening level da tabases, carbon disulfide discharges from cellulose film and sponge manufacturers are respons ible for the majority of the PMF Category’s discharge of toxic weighted pounds equivale nt (TWPE). These products are made from regenerated cellulose usi ng the viscose process, which is spec ifically excluded from the current PMF ELGs (see 40 CFR Part 463). Using screeni ng-level data, EPA identified the cellulose products manufacturers listed in Table 2-1.

Table 2-1. Cellulose Manufacturers in the United States a

TRI ID NPDES ID Facility Name Facility Location Product Type 14150GNRLM305SA NYR00D034 3M Corporation Tonawanda, NY Cellulosic Sponges

66542FLXLN6000S KS 0003204 Innovia Films Inc. Tecumseh, KS Cellophane
38402SPNTXSANTA TN0001571 Spontex Inc. Columbia, TN Cellulosic Sponges
61832TPKNC915NM ILR000333 Viscofan USA Inc. Danville, IL Meat Casings
37774VSKSCEASTL TN0001457 Viskase Corporation Loudon, TN Meat Casings
72370VSKSCRT198 AR0036544 Viskase Corporation Osceola, AR Meat Casings
36505CRTLDUSHIG AL0003026, AL0074497 Lenzing Fibers Corp. Axis, AL Rayon

37778BSFCRHWY16, 37778LNZNGTENNE TN0068187 Lenzing Fibers Corp. Lowland, TN Rayon

NA NA Nylonge Corp. Elyria, OH Cellulosic Sponges
53821MCMPN217NO NA 3M Corp. Prairie du Chien, WI Cellulosic Sponges

Source: TRIReleases2002_4 ; TRIReleases2003_2 ; Facility NPDES Permits (TDEC, 2002; IEPA, 2003; KDHE, 2001; ADEQ, 2000; TDEC, 2005); Industry Profile of the Cellulosic Products Manufacturing Facilities in the U.S. (Schmidtke, 2000).

As a result, EPA identified the need fo r further review of discharges from cellulose products manufacturing facilities. ERG will support EPA’s primary data and secondary data collection activities for this project. ERG w ill also support EPA in analyzing these data to better understand discharges from the PMF Cate gory. The following sections discuss the key questions that EPA intends to answer as a result of the data collection activities.

2.2.2 Statement of Key Questions and Project Objectives

Information acquired during data collection activities will be used to answer the following questions:

 What is the number and type of ce llulose product manuf acturing facilities discharging carbon disulf ide to U.S. waters?

 Are carbon disulfide discharges co mmon to all cellulose products manufacturing facilities?Section No. 2.0 Revision No. 0 Date: 2 November 2010 Page 4 of 9

 What is the quantity and concentra tion of carbon disulfide discharged (pollutant loading)?

 What is the fate and transport and resulting potential impact to human health and the environment from these discharges?

 Is there a demonstrated technol ogy, process change , or pollution prevention approach that can c ontrol carbon disulf ide discharges?

 What are the cost, performance, and affordability of any demonstrated treatment technologies reducing carbon disulfid e discharges?

 What are the implementation and efficiency considerations for treatment technologies as well as process change or pollution prevention measures that could be used?

2.3 Project/Task Description (Element A.6)

This subsection discusses the management of the work ERG will perform in support of the PMF Preliminary Category Review. ERG will perform this work at the direction of EPA, within the framework of Work Assignment 8-05 and a ny successor work assignments.

Under EPA Contract 68-C-02-095, ER G will support EPA by collecting and reviewing both primary and secondary data for the following purposes:

 Characterization of the cellulose products manufacturing subcategory (including development of a facility list);

 Review of carbon disulfide discha rges from cellulose products manufacturing facilities;

 Identification of potential impacts fr om PMF wastewater discharges; and

 Review of technologies appropriate for the treatment of wastewater discharges from the PMF Category.

To perform these tasks, ERG will collect and use primary and secondary data, as directed by the EPA WAM. ERG ex pects that EPA will collect pr imary data under the authority of Section 308 of the Clean Water Act by reques ting facility and treatment system information from nine cellulose products companies. Sec ondary data sources may include data from the rulemaking record supporting the National Emi ssion Standards for Hazardous Air Pollutants: Cellulose Products Manufacturing, reports documenting surface water impacts (e.g., TMDL studies), and wastewater treatment data (e.g., carbon disulfide tr eatability data).Section No. 2.0 Revision No. 0 Date: 2 November 2010 Page 5 of 9

2.3.1 Characterization of the Cellulose Products Manufacturing Subcategory

ERG expects that EPA will collect facil ity information from companies that manufacture cellulose products using an informal data request, in a letter format. The purpose of the letter will be to better unde rstand cellulose products manufactu ring wastewater and determine whether carbon disulfide discharg es can be treated, or whether further data collection is warranted. ERG expects that EPA will request su pport drafting the data request letter and expects to include the following questions in the data request:

1. How is carbon disulfide received?

a. Unloaded under nitrogen blanket b. Unloaded under water blanket

c. Other (describe).

2. What type of air pollution control is used in the receiving area and how much wastewater is generated?

3. How is carbon disulfide stored?

4. What type of air pollution control is used in the storage area and how much wastewater is generated?

5. How is carbon disulfide used in the pr ocess and what type of reactor is used?

6. What air pollution control is used in the process area, and how much wastewater is generated?

7. How much wastewater overall does your facil ity generate?

8. What are the sources of wa stewater at your facility?

9. What wastewater treatment is performed?

Please provide any wastewater characterization data you have for both in-process and end-ofpipe locations. Include a descri ption of the sample point, th e pollutants measured, and the sampling results.

ERG will summarize the facility information collected in a master facility list for the Cellulose Products Manufacturing Subcategory. The facility list will be sorted by geographic area and will include operator companies, major products and/or processes, wastewater treatment information, and applicable NDPES and TRI fac ility identification numbers. Section 3 discusses how data from the request will be managed.Section No. 2.0 Revision No. 0 Date: 2 November 2010 Page 6 of 9

2.3.2 Review of Carbon Disulfide Disc harges from Cellulose Products Manufacturing Facilities

ERG will summarize available discharge data from EPA’s TRI and DMR databases for carbon disulfide to determine whether it is present in wastewater from all cellulose products manufacturing facilities. ERG will also use these data to summarize the quantity and characteristics of carbon disulfide discharges across the industry. ERG will use the facility information discussed in Section 2.4.1 to evalua te the completeness of carbon disulfide discharge data and to determine whether additional data ar e needed. Specifically, ERG will determine what percent of the industry is represen ted in the screening-level data.

ERG will estimate the total carbon disulfid e load produced by cellulose products manufacturing facilities using th e compiled facility list and availa ble discharge information. The presentation of pollutant load estimates will in clude a description of the limited data set (e.g., discharge data for a limited set of facilities) from which the pollutant loads are calculated.

ERG will supplement screening-level data with data from industry trade group information and state and local wastewater perm its, as directed by the EPA WAM. These data will be used to verify screening-level data.

2.3.3 Identification of Potential Impacts from PMF Wastewater Discharges

ERG will conduct a literature search to identify reports and studies that discuss the fate and transport of carbon disulfide in wast ewater discharges and th e potential impacts to human health and the environment caused by these discharges. For example, ERG will begin with the data in the rulemaking record s upporting the National Emission Standards for Hazardous Air Pollutants: Cellulose Produc ts Manufacturing (August 10, 2005, 70 FR 46684). ERG will include other sources as directed by the EPA WAM. Literature sources may include risk assessments for carbon disu lfide, industry trade group inform ation, state and local permits, and Total Maximum Daily Load (TMDL) studies. In the event that no such information is available in the existing literatur e, ERG will note this finding at the conclusion of the study and list all sources consulted.

2.3.4 Review of Technologies Appropriate for the Treatment of Wastewater Discharges from the PMF Category

ERG will collect treatment system information from companies that manufacture cellulose products as part of the informal data request (see Section 3 of this QAPP). ERG will also summarize existing treatability data for carb on disulfide using sources such as the Risk Reduction Engineering Laboratory Treatab ility Database (available online at http://cfpub.epa.gov/npdes/pkeyword.cfm?keywor ds=permit+writers&program_id=0). ERG will use treatability data to evaluate technologies currently used for th e treatment of wastewater from the PMF Category, and to identify any new technologies that may be appropriate.Section No. 2.0 Revision No. 0 Date: 2 November 2010 Page 7 of 9

2.4 Quality Objectives and Accepta nce Criteria (Element A.7)

The primary objective of this QAPP is to ensure that the data collected for the PMF Preliminary Category Review are of the quality necessary to achieve the objectives discussed in this section. All project deliverables will meet EP A’s standards of transparency, objectivity, integrity, and utility as specified in EPA’s Guidelines for Ensuring and Maximizing the Quality, Objectivity, Utility, and Integrity of Information Disseminated (EPA, 2002). Documentation supporting the work presented in deliverables will identify the sources of data, assumptions made, and calculations used in thei r development with sufficient transparency to ensure the reproducibility of the work by qualified third parties.

Table 2-2 presents the accepta nce criteria for the literature review data sources identified by EPA and ERG. QA/QC activities that ERG will perform to ensure data and results meet these data quality specifications are pres ented in Section 3.0. Table 2-3 presents the acceptance criteria for the informal data request.

Table 2-2. Literature Review Source and Treatability Data Acceptance Criteria

Acceptance Criterion:

Literature Review Description/Definition Specification
Currency (up to date) Do the data reflect current conditions? Year of publication (or presentation, if a paper presented at a conference) Priority: 2000 or after. ERG will consider using older publications based on best professional judgment.
Accuracy/Reliability Are the data reported true?  U.S. government publication

 Peer-reviewed source ERG will consider using publications that do not fit these criteria based on best professional judgment.
Facility Scope a Does the information pertain to cellulose products manufacturing facilities? Facilities activities are classified under NAICS Codes 32511, 325199, 3252, 326121, and 326199

Analyte Scope b Do the data reported reflect pollutants of concern in this study? Focus on carbon disulfide only.

a – Applies only to facility and treatment system information. b – Applies only to the treatment efficiency data. Facility lists do not have analyte scope acceptance criteria.Section No. 2.0 Revision No. 0 Date: 2 November 2010 Page 8 of 9

Table 2-3. §308 Informal Data Request Data Acceptance Criteria

Acceptance Criterion: Data Request Description/Definition Specification
Unambiguous For an individual response, can the response to the question be interpreted without confusion?  Units of measure are identified.

 Responses to open-ended questions are clear.

 The question was interpreted consistently by multiple respondents.
Internal consistency For an individual response, are the answers to one question consistent with answers to other questions?  Responses to multiple questions asking for similar or related information are comparable and consistent.
Completeness For a facility’s response, were all questions answered? For each question, was it answered by all respondents?  A facility’s response includes answers all applicable questions.

 Each question is answered by all respondents to which it applies.
Representativeness Do the facilities that responded to the data request reflect the population of cellulose products manufacturing facilities?  Will be determined based on professional judgment and consultation with EPA WAM.

Comparability For a facility’s response, is the information provided in response to the §308 Data Request consistent with facility descriptions in NPDES permit documents, including the annual report?  Reported discharge flows, production, and/or pounds of waste discharged are not more than 50% different from the values reported in NOI and not more than 15% different from values included in the facility annual report.

2.5 Special Training/Certification (Element A.8)

Information and data collected throug h EPA data request activities may be claimed as confidential business information (CB I) by the PMF industry. Therefore, project staff will be trained in CBI handling procedures as ou tlined in ERG’s CBI security plan entitled Security Plan for Handling Confidential Busi ness Information Under the Clean Water Act , dated September 25, 2008 (ERG, 2008) and approved by Ahmar Siddiqui, EPA’s Document Control Officer for this contract, on March 12, 2009. Only staff demonstrating their understanding of CBI handling procedures by passing a written test will be permitted to access CBI on this project.

2.6 Documents and Records (Element A.9)

ERG has developed and instituted docume nt control mechanisms for revising and distributing QAPPs. Each QAPP ha s a signed approval form, title page, table of contents, and EPA-approved document control format (see header at the top of each page in this QAPP). During the course of the project, any revision to the approved QAPP will be circulated to all ERG and EPA staff supporting the PMF Preliminary Category Review and documented by a signature page for the revision. During this proj ect, ERG will circulate any revisions to the QAPP to everyone on the di stribution list in Table 1-1 of this QAPP.Section No. 2.0 Revision No. 0 Date: 2 November 2010 Page 9 of 9

ERG employs standard controls to ensure the quality of project-related data, documents, and records. ERG’s WA M is responsible for designati ng an individual to maintain all project files. She is also responsible for ensuring that proj ect team members have a second level of review for all calcula tions and analyses, that techni cal reviewers are used throughout project activities, and that all data sources us ed are documented. ERG will handle and store all secondary data collected, reviewed, and analyzed during the PMF Preliminary Category Review in a docket, as described in the 304(m) Project File Management Plan (ERG, 2009). This docket contains all data collected or accessed from ot her sources and documents analyses of data collected (e.g., calculations forms and analytical spreadsheets). The contents of the docket are indexed using a Microsoft Office AccessTM database.Section No. 3.0 Revision No. 0 Date: 2 November 2010 Page 1 of 4

3.0 D ATA G ENERATION AND A CQUISITION

In its Requirements of Quality Assurance Project Plans (EPA, 2001a), EPA identifies 10 elements to ensu re that appropriate methods for data collection and generation are employed and documented. The six elements that are applicable to the PMF Preliminary Category Review are:

 B.1: Sampling (data collection) process design;

 B.2: Sampling (data collection) methods;

 B.3: Sample (data) handling and custody;

 B.5: Quality control;

 B.9: Non-direct measurements; and

 B.10: Data management.

Elements B.1, B.2, B.3, and B.5 apply to the informal data request activities conducted for the PMF Preliminary Category Re view. Element B.9 applies to non-direct measurements (or secondary data). Element B .10 applies to the collect ion and analysis of responses to the data request. Because the data request does not collect sampling or monitoring data, but rather facility and tr eatment system configuration in formation, Elements B.4, B.6, B.7, and B.8 do not apply.

3.1 Sampling (Data Collection) Process Design (Element B.1)

The respondent universe for these data reque sts is made up of facilities from the NAICS code listed in Section 2.4 of this QAPP. EPA provided estimates for the number of facilities in this NAICS Code in the Tec hnical Support Document for the 2010 Effluent Guidelines Program Plan (EPA, 2010). ERG expect s that EPA will distribute data requests to nine or less companies that manufacture cellulose products in the U.S. To identify data request recipients, ERG expects that EPA will direct ER G to identify all facilities that manufacture cellulose products in the U.S., based on TRI, NESHAP, and industry trade group information. ERG expects that EPA will select companies to receive the informal data request based on including all cellulose product type s (fibers, tubes, sheets, and sponges). Also, ERG expects that EPA will request support in identifying the comp anies with greatest production of cellulose products and/or wastewater discharges.

Following receipt from EPA of the final sample frame and final mailing list of facilities to receive the data reque st, ERG will mail the data requests to the selected facilities via Federal Express or comparable carrier to ensure that a point of contact (the facility contact person) receives and signs for the data request package.

3.2 Sampling (Data Collection) Methods (Element B.2)

The data collection will be conducted on a mandatory basis under Section 308 authority. QC activities associated with the mailout process in clude the following:Section No. 3.0 Revision No. 0 Date: 2 November 2010 Page 2 of 4

 Checks of the mailing addresses to ensu re that they are valid addresses;

 Tracking of the mailout through either Fe deral Express trackin g mechanisms or USPS registered mail receipts;

 Tracking of the returned data requests to identify facilities that did not respond or provided incomplete responses;

 Reviewing responses for consistency, accuracy, and reasonableness, including developing a technical review checklist; and

 Follow-up communication with facilities providing incomplete responses, including documentation of such follow up.

In the EPA data request, information will be collected for calendar year 2010.

3.3 Sample (Data) Handling and Custody (Element B.3)

Completed data requests will be mailed to ERG, where they will be tracked in a database logged into ERG’s 304m Project File. ERG will develop procedures to track survey mailing and receipt, for EPA WAM approval. ERG’s standard controls for project-related data, documents, and records are presented in the 304m Project File Management Plan (ERG, 2009). See Section 3.6 for a discussion of ERG’s SOPs for maintaining spread sheets and databases.

3.4 Quality Control (Element B.5)

ERG will maintain the quality and comp leteness of data request responses through the followi ng activities:

 Develop technical review guidelines for EPA WAM approval, and follow these guidelines during data request review.

 Offer assistance to respondents in comp leting the data request through a telephone helpline. Helpline assistance will be doc umented and placed in the study record.

 Check the consistency and completeness of the data for 100 percent of the

responses.

 Conduct follow-up with respondents by telephone and/or e- mail to resolve missing, illegible, or inconsistent information. All communication with respondents will be documented and placed in the study record.

ERG will ensure that all information co llected is entered into a spreadsheet designed for this project, as described in Section 3.6.Section No. 3.0 Revision No. 0 Date: 2 November 2010 Page 3 of 4

3.5 Non-Direct Measurements (Element B.9)

Non-direct measurements means data or information obtained from existing data sources, not directly measured or generated on th is project. The term “s econdary data” is also used for such existing data that were collected for another purpose. This project includes collecting and using the following types of secondary data:

 Literature review data (supporting surface water impacts analysis); and

 Pollutant treatability data.

Section 2.4 discusses the pla nned uses of secondary data sources for use in the PMF Category Review. Table 2-1 presents the accep tance criteria for seco ndary data sources to be used in the PMF Preliminary Category Review . ERG will use secondary data sources for this study as directed by the EPA WAM.

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

 ERG researchers will collect full bibliographic information on all collected publications, in cluding “date accessed” for information collected from the Internet.

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

 ERG researchers will submit the publica tions and meta data to the project file index keeper. The index keeper will add meta data describing the publications to the 304 (m) Record Index. Following the procedures detailed in the project file manageme nt plan, the index keeper will add the publication file to the PMF Project File.

3.6 Data Management (Element B.10)

ERG expects to provide the data request to recipients in hard copy and electronic format (Microsoft Word ® ). For this project, ERG will design a spreadsheet according to ERG’s Standard Operating Procedure for Developing, Do cumenting, and Evaluating the Accuracy of Spreadsheet Data to store information collected from th e data request, attached as Appendix A. Following ERG’s technical review and follow-up of the responses to the data requests, ERG will key-enter information from hardcopy responses or electronically copy information from electronic responses into the spreadsheet. ERG expects to perform a 100 percent check of all key-entered and electronically copied data, based on the receipt of responses from nine companies. However, ERG will follow EPA direction if the amount of data collected is too large to accommodate a 100 percent check of data tran scription. Regardless, if ERG identifies a high rate of errors (more than 10 percent) in the entered data, ERG will notify the EPA WAM andSection No. 3.0 Revision No. 0 Date: 2 November 2010 Page 4 of 4

perform a check of all key-entered data. The data base will be stored electronically on the ERG network or ERG’s CBI server, if data are marked CBI.

To ensure that the database is comple te, ERG will maintain a checklist of responses to the data requests and will “check off” the respondents for whom responses have been entered into the spreadsheet.

Documentation for the data request task in cludes the responses, revisions, or edits made by the data request reviewer, the comp leted data request review checklist, and documentation of communications with facility cont acts via the helpline or follow-up e-mails or telephone calls. The data re quest review task leader or his/her designee will ensure that the data request review documentation is legible and co mplete. ERG will follow up with organizations that provide illegible or incomplete responses. ERG will log these records into the project file and copies of these records will be provided to EPA as requested. ERG’s standard controls for project-related data, documen ts, and records are presente d in Section 5 of the 2002 QMP

.Section No. 4.0 Revision No. 0 Date: 28 November 2010 Page 1 of 2 4.0 ASSESSMENT AND OVERSIGHT ELEMENTS

This section describes the methods ERG will use to assess the quality of the work conducted for the PMF Preliminary Category Review.

4.1 Assessments and Response Actions (Element C.1)

Section 3.1 describes the tech nical review, audits, and co rrective actions that ERG will conduct on the PMF Preliminary Category Review.

All work conducted on the PMF Preliminary Category Review will be subject to technical review, which is a docum ented critical review of work that has been performed within the “state of the art” and will be conducted by ERG’s WAM. ERG will document all reviews of project deliverables in a “Deliv erable Sign-Off Sheet.” All deli verables will subsequently be reviewed by EPA’s PMF Task Lead.

ERG’s Project QA Coordinator for this project or her designee will assess the implementation of QA/QC procedures on this pr oject. Her primary role includes reviewing the QAPP (this document) for completeness and applicab ility and auditing the pr oject files to ensure that the follow QA activities are occurring:

 Project staff have developed and are using QC procedures; and

 Project staff are following the deli verable review process and using document sign-off sheets.

At any time or at the end of the projec t or work assignment, the Corporate QA Manager or her designee may in spect the project QA files.

4.2 Reports to Management (Element C.2)

Any quality deficiencies detected by t echnical reviewers or the Project QA Coordinator will be communicated, in wr iting, to the ERG WAM. The ERG WAM is responsible for ensuring that appropriate correctiv e action is taken and re ported to the Project QA Coordinator.

QA reports will be incorporated into our monthly technical progress reports which will be supplemented 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;Section No. 4.0 Revision No. 0 Date: 28 November 2010 Page 2 of 2

 Identification of any deviat ions from the QAPPs; and

 Identification of problem resolution and/or corrective act ions taken during the reporting period, if any.Section No. 5.0 Revision No. 0 Date: 28 November 2010 Page 1 of 1 5.0 DATA VALIDATION AND USABILITY ELEMENTS

This section describes review, verificati on, and validation of data collected from manufacturing companies and literature review s ources to determine if they adequately answer the questions posed in Section 2.2.2 and meet the objectives stated in Section 2.4.

5.1 Data Review, Verification, and Va lidation; and Validation Methods (Element D.1 and D.2)

Data review is an in-house data examin ation to ensure that data have been recorded and transmitted correctly (e.g., by checking for transcription and calculation errors). ERG will use procedures appropriate to the data source and transmission method to verify that data have been transcribed accurately. Data ve rification involves examining and reviewing the objective evidence to confirm that the data are complete, correct, consistent, and in compliance with technical requirements, esta blished standards, and contractua l requirements. Data validation entails a person different from the data generato r confirming that the par ticular requirements for a specific intended use are fulfilled. Verification pr ocedures for environmental end-points data include proof-reading and spot checking of any data transcri bed into a new database or spreadsheet. All data entries will be proof read to verify data transcription accuracy.

The PMF Preliminary Category Review involves collecting and using existing environmental data for purposes other than thos e for which they were originally collected. Section 2.5 describes the data quality indicators that ERG will implement to determine if these secondary data are suitable for EPA’s us e in characterizing th e Cellulose Products Manufacturing Subsector and associated wastewat er discharges. ERG will include only sources that meet the quality requirements sp ecified in Section 2.5 in the analysis.

5.2 Reconciliation with User Re quirements (Element D.3)

The primary objective of this QAPP is to ensure that data collected are of the quality necessary to support EPA’s PMF Preliminary Category Review.

ERG will describe data quality and limitations in its reports so later data users may determine if the data are of sufficient quality for their use. ERG will work with EPA to determine to what extent data that do not meet the specified data acceptance criteria may be used to support the PMF Preliminary Category Revi ew and how this determination will be documented.

ERG will include an evaluation of data qua lity in all project deliverables. ERG will also identify the sources of data, assumptions made, and calculations used in their development in all project deliverables. These identifications will be sufficiently detailed and transparent to ensure the repr oducibility of the work by qualifi ed third parties. All project deliverables will meet EPA’s standards of transp arency, objectivity, integrity, and utility as specified in EPA’s Information Quality Guidelines (EPA, 2002).Section No. 6.0 Revision No. 0 Date: 28 November 2010 Page 1 of 1 6.0 R EFERENCES

Beach, Robert. Buckley, Mark. Depr o, Brooks. Van Houtven, George. 2000. Economic Analysis or Air Pollution Regulations: Miscellane ous Cellulose Manufacturing Industry

. February 2000.

EPA. 2001a. EPA Requirements for Quality Assurance Project Plans QA/R-5. EPA/240/B01/003. U.S. Environmental Protection Agency, Office of Environmental Information. March
2001.

EPA.2001b. EPA Requirements for Qu ality Management Plans QA/R-2 , EPA/240/B-01/002, Office of Environmental Information, 2001.

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

ERG. 2002a. Quality Management Plan for Technical Support for the Strategy for National Clean Water Industrial Regulations

. June 2002.

ERG. 2002b. Standard Operating Procedure for Deliverab le Review Sign-Off Sheets, SOP No:
ERG-CHA-001 . December 10, 2002.

ERG. 2002c. Standard Operating Procedure for Developing, Documenting, and Evaluating the Accuracy of Spreadsheet Data, SOP No: ERG-CHA-002 . December 10, 2002.

U.S. EPA. 2006. Technical Support Document for the 2006 Effluent Guidelines Program Plan

. EPA 821-R-06-018. Washington, DC. (December). EPA-HQ-OW-2004-0032-2782.

ERG, 2008. Security Plan for Handling Confidential Business Information Under the Clean
Water Act . September 25, 2008.

ERG. 2009. 304(m) Project File Management Pl an. Eastern Research Group, Inc . Revised January 7, 2009.

U.S. EPA. 2010. Technical Support Document for the 2010 Effluent Guidelines Program Plan

. EPA 821-R-04-014. Washington, DC. (August).Appendix A

ERG STANDARD OPERATING PROCEDURES