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 8-05 
i

TITLE AND APPROVAL SHEET

Quality Assurance Project Plan for the Plastics 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, Technology and Statistics Branch Date 
ii

TABLE OF CONTENTS 

Page 

1.0 INTRODUCTION ..................................................................................................... 1-1 

2.0 PROJECT MANAGEMENT ELEMENTS ..................................................................... 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 Appropriate for the Treatment of 

Wastewater Discharges from the PMF Category ......................... 2-6 

2.4 Quality Objectives and Acceptance Criteria (Element A.7) .................... 2-7 

2.5 Special Training/Certification (Element A.8) .......................................... 2-8 

2.6 Documents and Records (Element A.9) ................................................... 2-8 

3.0 DATA GENERATION AND ACQUISITION ................................................................. 3-1 

3.1 Sampling (Data Collection) Process 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 Validation; and Validation Methods 

(Element D.1 and D.2) ............................................................................. 5-1 

5.2 Reconciliation with User Requirements (Element D.3) ......................... 5-1 

6.0 REFERENCES ......................................................................................................... 6-1 

Appendix A: ERG STANDARD OPERATING PROCEDURES 
iii

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 Treatability 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 .............................................................................. 2-2 
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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 project 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.com 
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1.0 INTRODUCTION

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 categories that discharge directly to waters of the 

United States. EPA establishes analogous pretreatment standards for discharges to publicly 

owned treatment works (POTWs). The Clean Water Act (CWA) sections 301(d), 304(b), 304(g), 

and 307(b) require EPA to annually review these regulations. 

CWA section 304(b) requires EPA to review its existing effluent limitations 

guidelines for direct dischargers each year and to revise such regulations “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 effluent guideline selected for 

possible revision as a result of that annual review. 

EPA’s annual review of existing ELGs, referred 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 pollutant sources 

and pollutant reduction approaches to determine if EPA should identify 

any of the prioritized categories for possible revision of their existing 

effluent guidelines and/or pretreatment standards. 

This Quality Assurance Project Plan (QAPP) covers the second step, preliminary review, for one 

prioritized category. Specifically, this QAPP covers the analysis of the Cellulose Products 

Manufacturing Subcategory of the Plastics Molding and Forming (PMF) Point Source Category1

. 

Analysis of the Cellulose Products Manufacturing Subcategory may include the collection of 

primary data (e.g., facility information, wastewater treatment information) and the use of 

secondary data (e.g., existing treatability data, data collected during literature searches) to better 

understand wastewater discharges from the Cellulose Products Manufacturing Subcategory. 

Based on currently available information, discharges from cellulose products 

manufacturing facilities may contain significant quantities of carbon disulfide and other toxic 

pollutants. Because cellulose products manufacturing 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 discharges warrants regulation by technology-based standards. 

 

1

 According to Beach et al. (2000), the Cellulose Products Manufacturing Subcategory includes facilities covered by 

NAICS codes 32511, 325199,3252, 326121, and 326199. 
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As part of the PMF Preliminary Category Review, ERG will collect facility 

information to characterize the industry, wastewater treatment information to understand 

currently used treatment technologies, 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 support we will provide in collecting primary data 

(e.g., facility information, wastewater treatment information) and using secondary data (e.g., 

treatability data, surface water impacts data collected 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 Strategy for National Clean Water Industrial Regulations, June 2002

(EPA, 2002a), which was prepared in accordance with EPA Requirements for Quality 

Management Plans (EPA, 2001b). ERG’s Quality Assurance (QA) coordinators and project 

management team plan, implement, and assess project quality procedures throughout all project 

levels. These procedures, tailored to the needs of the tasked activities, will be used on this work 

assignment. 
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2.0 PROJECT MANAGEMENT ELEMENTS

This section addresses project management, including project history and 

objectives, roles and responsibilities, and project 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 collection and literature review conducted under the 

PMF Preliminary Category Review. In its Requirements of Quality Assurance Project Plans 

(EPA, 2001), EPA identifies nine project management 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 organization for the PMF Preliminary Category 

Review. ERG’s WAM will be responsible for ensuring that the quality of work, schedule, and 

budget meet the requirements of the PMF Preliminary Category Review. The ERG WAM will be 

the principal contact for the EPA WAM and 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 responsible 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 better understand wastewater discharges from the PMF Category. ERG 

staff will also assist in producing documents reporting the findings of the data review. The ERG 

Project QA Coordinator will review this QAPP to confirm it specifies the quality 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 appropriate 

technical review of all documents.
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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 the 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 for 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 Effluent Guidelines Program Plan, EPA designated 

the PMF Category for a preliminary category review 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 Staff

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 Authority
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EPA is specifically focusing on cellulose products manufacturing facilities 

because their discharges were the top concern for the PMF Category during the 2010 annual 

review. According to EPA’s screening level databases, carbon disulfide discharges from 

cellulose film and sponge manufacturers are responsible for the majority of the PMF Category’s 

discharge of toxic weighted pounds equivalent (TWPE). These products are made from 

regenerated cellulose using the viscose process, which is specifically excluded from the current 

PMF ELGs (see 40 CFR Part 463). Using screening-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 KS0003204 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 for 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 will also support EPA in analyzing these data to 

better understand discharges from the PMF Category. 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 cellulose product manufacturing facilities 

discharging carbon disulfide to U.S. waters? 

 Are carbon disulfide discharges common to all cellulose products 

manufacturing facilities? 
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 What is the quantity and concentration 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 technology, process change, or pollution 

prevention approach that can control carbon disulfide discharges? 

 What are the cost, performance, and affordability of any demonstrated 

treatment technologies reducing carbon disulfide 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 any successor work assignments. 

Under EPA Contract 68-C-02-095, ERG 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 discharges from cellulose products 

manufacturing facilities; 

 Identification of potential impacts from 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 expects that EPA will collect primary data under the authority 

of Section 308 of the Clean Water Act by requesting facility and treatment system information 

from nine cellulose products companies. Secondary data sources may include data from the 

rulemaking record supporting the National Emission 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 treatability data). 
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2.3.1 Characterization of the Cellulose Products Manufacturing Subcategory 

ERG expects that EPA will collect facility 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 understand cellulose products manufacturing wastewater and determine 

whether carbon disulfide discharges can be treated, or whether further data collection is 

warranted. ERG expects that EPA will request support 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 process 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 facility generate? 

8. What are the sources of wastewater 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 description of the sample point, the 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 facility identification numbers. Section 3 discusses 

how data from the request will be managed. 
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2.3.2 Review of Carbon Disulfide Discharges 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 evaluate the completeness of carbon disulfide discharge 

data and to determine whether additional data are needed. Specifically, ERG will determine what 

percent of the industry is represented in the screening-level data. 

ERG will estimate the total carbon disulfide load produced by cellulose products 

manufacturing facilities using the compiled facility list and available discharge information. The 

presentation of pollutant load estimates will include 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 permits, 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 wastewater discharges and the potential impacts to 

human health and the environment caused by these discharges. For example, ERG will begin 

with the data in the rulemaking record supporting the National Emission Standards for 

Hazardous Air Pollutants: Cellulose Products 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 disulfide, industry trade group information, state and local permits, 

and Total Maximum Daily Load (TMDL) studies. In the event that no such information is 

available in the existing literature, 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 carbon disulfide using sources such as the Risk 

Reduction Engineering Laboratory Treatability Database (available online at 

http://cfpub.epa.gov/npdes/pkeyword.cfm?keywords=permit+writers&program_id=0). ERG will 

use treatability data to evaluate technologies currently used for the treatment of wastewater from 

the PMF Category, and to identify any new technologies that may be appropriate. 
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2.4 Quality Objectives and Acceptance 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 EPA’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 their development with sufficient transparency to 

ensure the reproducibility of the work by qualified third parties. 

Table 2-2 presents the acceptance 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 presented 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. 
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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 through EPA data request activities may be 

claimed as confidential business information (CBI) by the PMF industry. Therefore, project staff 

will be trained in CBI handling procedures as outlined in ERG’s CBI security plan entitled 

Security Plan for Handling Confidential Business 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 document control mechanisms for revising and 

distributing QAPPs. Each QAPP has 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 project, ERG will circulate any revisions to the 

QAPP to everyone on the distribution list in Table 1-1 of this QAPP. 
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ERG employs standard controls to ensure the quality of project-related data, 

documents, and records. ERG’s WAM is responsible for designating an individual to maintain 

all project files. She is also responsible for ensuring that project team members have a second 

level of review for all calculations and analyses, that technical reviewers are used throughout 

project activities, and that all data sources used 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 other 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. 
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3.0 DATA GENERATION AND ACQUISITION

In its Requirements of Quality Assurance Project Plans (EPA, 2001a), EPA 

identifies 10 elements to ensure 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 Review. Element B.9 applies to non-direct 

measurements (or secondary data). Element B.10 applies to the collection and analysis of 

responses to the data request. Because the data request does not collect sampling or monitoring 

data, but rather facility and treatment system configuration information, 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 requests 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 Technical Support Document for the 2010 Effluent 

Guidelines Program Plan (EPA, 2010). ERG expects 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 ERG 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 types (fibers, tubes, sheets, and sponges). Also, ERG expects that 

EPA will request support in identifying the companies 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 request, 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 include the following: 
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 Checks of the mailing addresses to ensure that they are valid addresses; 

 Tracking of the mailout through either Federal Express tracking 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 spreadsheets and databases. 

3.4 Quality Control (Element B.5)

ERG will maintain the quality and completeness of data request responses 

through the following activities: 

 Develop technical review guidelines for EPA WAM approval, and follow these 

guidelines during data request review. 

 Offer assistance to respondents in completing the data request through a telephone 

helpline. Helpline assistance will be documented 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 collected is entered into a spreadsheet 

designed for this project, as described in Section 3.6. 
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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 this project. The term “secondary 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 planned uses of secondary data sources for use in the 

PMF Category Review. Table 2-1 presents the acceptance criteria for secondary 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, including “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 publications 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 management 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, Documenting, and Evaluating the Accuracy of 

Spreadsheet Data to store information collected from the 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 transcription. Regardless, if ERG identifies a high 

rate of errors (more than 10 percent) in the entered data, ERG will notify the EPA WAM and 
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perform a check of all key-entered data. The database will be stored electronically on the ERG 

network or ERG’s CBI server, if data are marked CBI. 

To ensure that the database is complete, 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 includes the responses, revisions, or edits 

made by the data request reviewer, the completed data request review checklist, and 

documentation of communications with facility contacts via the helpline or follow-up e-mails or 

telephone calls. The data request review task leader or his/her designee will ensure that the data 

request review documentation is legible and complete. 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, documents, and records are presented in Section 5 of the 2002 QMP. 

 
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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 technical review, audits, and corrective 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 documented 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 “Deliverable Sign-Off Sheet.” All deliverables 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 project. Her primary role includes reviewing the 

QAPP (this document) for completeness and applicability and auditing the project 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 deliverable review process and using 

document sign-off sheets. 

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. 

4.2 Reports to Management (Element C.2)

Any quality deficiencies detected by technical reviewers or the Project QA 

Coordinator will be communicated, in writing, to the ERG WAM. The ERG WAM is 

responsible for ensuring that appropriate corrective action is taken and reported 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; 
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 Identification of any deviations from the QAPPs; and 

 Identification of problem resolution and/or corrective actions taken during 

the reporting period, if any. 
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5.0 DATA VALIDATION AND USABILITY ELEMENTS 

This section describes review, verification, and validation of data collected from 

manufacturing companies and literature review sources 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 Validation; and Validation Methods 

(Element D.1 and D.2)

Data review is an in-house data examination 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 verification involves examining and reviewing the 

objective evidence to confirm that the data are complete, correct, consistent, and in compliance 

with technical requirements, established standards, and contractual requirements. Data validation 

entails a person different from the data generator confirming that the particular requirements for 

a specific intended use are fulfilled. Verification procedures for environmental end-points data 

include proof-reading and spot checking of any data transcribed 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 those 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 use in characterizing the Cellulose Products 

Manufacturing Subsector and associated wastewater discharges. ERG will include only sources 

that meet the quality requirements specified in Section 2.5 in the analysis. 

5.2 Reconciliation with User Requirements (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 Review and how this determination will be 

documented. 

ERG will include an evaluation of data quality 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 reproducibility of the work by qualified third parties. All project 

deliverables will meet EPA’s standards of transparency, objectivity, integrity, and utility as 

specified in EPA’s Information Quality Guidelines (EPA, 2002). 
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6.0 REFERENCES 

Beach, Robert. Buckley, Mark. Depro, Brooks. Van Houtven, George. 2000. Economic Analysis 

or Air Pollution Regulations: Miscellaneous 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 Quality 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 Protection 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 Deliverable 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 Plan. 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