Quality Assurance Project Plan: 

Dental Amalgam Effluent Guidelines 

Regulatory Support

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

Revision 2 July 31, 2014

Contract No. EP-C-12-021

Work Assignment 1-36
Revision No. 2

Date: July 31, 2014

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Quality Assurance Project Plan for Dental Amalgam Effluent Guidelines Regulatory 

Support

Revision 2

APPROVAL SHEET

7/28/2014

Jill Lucy - ERG Work Assignment Manager Date

7/29/2014

Mary Willett - ERG Project Quality Assurance Coordinator Date

 7/30/2014 

Deborah Bartram - ERG Program Manager Date
Revision No. 2

Date: July 31, 2014

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iii

History of Quality Assurance Project Plan (QAPP) for Dental Amalgam Effluent 

Guidelines Regulatory Support

Revision 0

Delivery Date January 1, 2011

Work Assignment Contract No. 68-C-02-095, 8-36

Scope Covers work performed for EAD under Contract 68-C-02-

095 including existing data collection, evaluation, 

analysis, and use.

Comments Received EPA Comments on First Draft; received 2/14/2011

Comments Addressed ERG Second Draft QAPP delivered 2/21/2011

Approval 2/25/2011

Revision 1

Delivery Date December 1, 2011

Work Assignment Contract No. 68-C-02-095, 9-36

Scope Covers work performed for EAD under Contract 68-C-02-

095 including existing data collection, evaluation, 

analysis, and use.

Comments Received No comments

Comments Addressed No comments

Approval 1/26/2012

Revision 2

Delivery Date July 31, 2014

Work Assignment 1-36

Scope Covers work performed for EAD under Contract EP-C12-021including existing data collection, evaluation, 

analysis, and use.

Comments Received No comments

Comments Addressed No comments

Approval 9/4/2014
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List of Revision 2 Updates

Section 

Number

Page 

Number Revision

1.0 1-1 Updated Table 1-1.

2.1 2-1 Added reference to ERG’s Environmental Engineering Support for Clean Water 

Regulations Programmatic Quality Assurance Project Plan (PQAPP).

2.1 2-2 Updated Figure 2-1.

2.2 2-2 Updated tons of mercury being discharged by dental offices.

2.2 2-2 Added that new fillings placed by dentists are called ―restorations.‖

2.2 2-2 Removed sentence ―Some of the waste amalgam particles settle out in the sewers, 

and some are carried to POTWs.‖

2.2 2-3 Modified text to list tasks performed under Work Assignment 8-36 and Work 

Assignment 9-36 of Contract No. 68-C-02-095, and anticipated work under 

Contract EP-C-12-021, Work Assignment 1-36.

2.4.1 2-5 Table 2-1: Under Accuracy/Reliability, added ―Is the scientific work clearly 

written so that all assumptions and methodologies can be identified?‖ 

2.4.3 2-6 Updated text to describe work performed under Work Assignment 9-36.

2.5 2-7 Updated ERG’s CBI security plan title and dates.

3.1.1 3-3 Updated text to describe work performed under Work Assignment 9-36.

3.1.2 3-5 Updated text to describe work performed under Work Assignment 9-36.

3.3 3-5 Updated text to describe work performed under Work Assignment 9-36.

6.0 6-1 Changed references from ―EPA‖ to ―U.S. EPA,‖ updated ERG security plan 

reference, and added PQAPP.
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TABLE OF CONTENTS

Page

1.0 DISTRIBUTION (ELEMENT A.3) .........................................................................................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

2.3 Project/Task Description (Element A.6)..............................................................2-3

2.3.1 Secondary Data Collection and Use ........................................................2-4

2.3.2 Secondary Data Activities Supporting Dental Amalgam ELG................2-4

2.4 Quality Objectives and Acceptance Criteria (Element A.7)................................2-4

2.4.1 Literature and Other Information Search and Review.............................2-4

2.4.2 Amalgam Separator Technology Costs ...................................................2-5

2.4.3 Amalgam Separator Technology Cost Estimates ....................................2-6

2.5 Special Training/Certification (Element A.8)......................................................2-7

2.6 Documents and Records (Element A.9)...............................................................2-7

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

3.1 Non-Direct Measurements (Secondary Data) (Element B.9) ..............................3-1

3.1.1 Activities and Procedures for Collection and Use of Secondary 

Data ..........................................................................................................3-2

3.1.2 QC Activities Related to Collection and Use of Secondary Data............3-4

3.2 Data Management (Element B.10) ......................................................................3-5

3.2.1 Project File Management and QC Activities...........................................3-5

3.3 Amalgam Separator Technology Costing............................................................3-5

3.3.1 Development of Cost Estimates...............................................................3-6

3.3.2 QC Activities Related to Development of Cost Estimates ......................3-6

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 

(Elements 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: CHECK LISTS AND SIGN-OFF SHEETS
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LIST OF TABLES

Page

Table 1-1. QAPP Distribution List .............................................................................................. 1-1

Table 2-1. Literature Review Data Acceptance Criteria.............................................................. 2-5

Table 2-2. Treatment Technology Cost Data Acceptance Criteria.............................................. 2-6

Table 2-3. Cost Estimate Quality Specifications......................................................................... 2-6

Table 4-1. Reporting QA/QC Activities...................................................................................... 4-2

Table 5-1. Summary of Data and Results Quality Verification................................................... 5-1

LIST OF FIGURES

Page

Figure 2-1. Project Level QA Organization for ERG’s Support for the Dental Amalgam 

Rulemaking...................................................................................................................... 2-2

Figure 3-1. Telephone Contact Report Form............................................................................... 3-3
Section No. 1.0

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1.0 DISTRIBUTION (ELEMENT A.3)

This Quality Assurance Project Plan (QAPP) will be distributed to staff of the 

U.S. Environmental Protection Agency and Eastern Research Group, Inc. (Table 1-1). A copy of 

the document will be provided to all Eastern Research Group, Inc. staff involved in the project, 

including those who join the project after publication of the QAPP.

Table 1-1. QAPP Distribution List

Name

Title Contact Information Mailing Address

U.S. Environmental Protection Agency

Meghan Hessenauer

Technical Project Officer

(202) 566-1040

hessenauer.meghan@epa.gov

U.S. Environmental Protection Agency

Office of Science and Technology

1200 Pennsylvania Avenue, NW (4303T)

Washington, DC 20460

(202) 566-1053 (fax)

Marion Kelly

EAD Quality Assurance 

Coordinator

(202) 566-1045 

kelly.marion@epa.gov

Damon Highsmith

Work Assignment Manager

(202) 566-2504

highsmith.damon@epa.gov

Jan Matuszko, 

Branch Chief, Engineering and 

Analytical Support Branch 

(202) 566-1035

matuszko.jan@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)

Betsy Bicknell

Project Quality Assurance 

Coordinator

(703) 633-1612

Betsy.Bicknell@erg.com

Jill Lucy

Work Assignment Manager

(703) 622-0322 

Jill.Lucy@erg.com

Kimberly Bartell

Environmental Engineer

(517) 515-1721

Kimberly.Bartell@erg.com
Section No. 2.0

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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 EPA and ERG will use to ensure that all participants understand the goals and the 

approach to be used for this project. In its Requirements of Quality Assurance Project Plans 

(U.S. EPA, 2001), EPA identifies the following nine project management elements: 

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 through A.3 have been provided earlier in this document. The 

remaining elements are presented below.

2.1 Project Organization (Element A.4) 

Project Organization is depicted in Figure 2-1, listing the staff with program 

management and technical responsibilities and those with QA/QC roles. It shows the relationship 

and lines of communication among all project participants, including those from EPA. 

ERG’s Work Assignment Manager (WAM) will be responsible for ensuring that 

the quality of work, schedule, and budget meet project requirements. She will provide technical 

direction to ERG staff and will be responsible for the daily activities on the project. The ERG 

WAM will be the principal contact for the EPA WAM on project issues, deliverables, and 

schedule. The ERG WAM will also keep the Project QA Coordinator and the ERG Program 

Manager advised of any quality problems that arise. The ERG Project QA Coordinator is 

responsible for the development and execution of QA activities throughout the course of the 

project, including all data collection activities. ERG’s Environmental Engineering Support for 

Clean Water Regulations Programmatic Quality Assurance Project Plan (PQAPP) (ERG, 2013) 

provides an expanded list of project staff responsibilities. 
Section No. 2.0

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Figure 2-1. Project Level QA Organization for ERG’s Support for the Dental Amalgam 

Rulemaking

2.2 Problem Definition/Background (Element A.5) 

EPA is initiating an effluent guideline rulemaking for dental facilities to reduce 

discharges of mercury to the environment. EPA estimates that dentists discharge approximately 

4.4 tons of mercury each year to publicly-owned treatment works (POTWs). Mercury is a 

concern to human health because it is a persistent bioaccumulative toxic element. Mercurycontaining amalgam wastes can enter the environment when new fillings are placed 

(restorations) or old mercury-containing fillings are removed, and the wastes are flushed into the 

chair-side drains. Treatment processes at POTWs remove approximately 90 to 95 percent of the 

mercury received in the wastewater. The mercury removed from the wastewater then resides in 

the biosolids or sewage sludge generated during treatment. 

Reporting/authority

 Communication

EAD QA Coordinator

Marion Kelly

ERG CEO

Corporate QA Manager

Mary Willett EPA Project Officer

Meghan Hessenaeur

EnvironmentalEngineering

Support Contract Program

Manager

Deb Bartram

Environmental

Engineering Support

Contract QA Manager

Mary Willett

Local QA

Coordinators

(QACs)

Environmental

Engineering Support

Contract WA Manager

Jill Lucy

Environmental

Engineering Support

Contract WA QAC

BetsyBicknell

EPA WA Manager

Damon Highsmith

Technical Reviewer

Mary Willett

ERG Technical Staff
Section No. 2.0

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EPA began a study of this industry as part of its 2006 Effluent Guidelines Plan, 

and completed the Health Services Industry Detailed Study Report for Dental Amalgam in 

August 2008 (EPA-821-R-08-014). Among other things, the 2008 report provided an industry 

profile, information on the types and effectiveness of amalgam separators available, information 

on mercury discharges from dental facilities, and information on existing state and local 

amalgam separator requirements. EPA collected secondary data and performed a preliminary 

review of existing treatability studies on dental amalgam separators as part of the Health Services 

Industry Detailed Study, in the spring of 2008 under Work Assignment 5-05 of Contract No. 68-

C-02-095. Under Work Assignment 8-36 of Contract No. 68-C-02-095, ERG performed 

additional secondary data collection on amalgam separators, including costs for separators and 

polishing systems, and developed a costing and loading analyses spreadsheet. Under Work 

Assignment 9-36 of Contract No. 68-C-02-095, ERG provided technical support to EAD in 

developing regulations for dental facilities, including cost and effectiveness calculations for 

amalgam separators and best management practices (BMPs) and loadings calculations. Under 

Work Assignment 1-36 of Contract EP-C-12-021, ERG will provide technical support to EAD to 

complete the technical and economic development document (TEDD) and record items for the 

proposed regulation.

2.3 Project/Task Description (Element A.6) 

In evaluating and proposing this rulemaking, among other things, EPA needs to 

describe the industry (e.g., how many dentists, how many discharge mercury, etc) and determine 

the baseline (e.g., current mercury discharges and current treatment in place, if any). EPA also 

needs to evaluate possible technology bases to reduce these discharges further, examine the 

effectiveness of such technologies, their associated costs, and estimate mercury reductions 

associated with their use. EPA anticipates using only readily available data for this rulemaking. 

It does not anticipate an information collection request (ICR) or wastewater sampling.

ERG will continue to support EPA’s secondary data collection efforts to help 

inform the above. Secondary data that ERG will use on this work assignment include technical 

literature pertaining to dental amalgam and its discharge, such as information obtained from 

vendors about the effectiveness and costs of dental amalgam separators, information obtained 

from the American Dental Association (ADA), information from studies performed by the 

National Association of Clean Water Agencies (NACWA), publicly available industry profile

information, such as Census information, Risk Management Association’s (RMA) Annual 

Statement Studies, Small Business Administration’s (SBA) Table of Small Business Size 

Standards Matched to North American Industry Classification Codes, the Almanac Financial of 

Business and Industrial Ratios, and data on the treatment and pass through of mercury at 

POTWs.

This subsection provides a management level overview of the work ERG will 

perform in support of this project, as directed by EPA. 
Section No. 2.0

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2.3.1 Secondary Data Collection and Use

ERG is supporting EPA in the following activities for collection and use of 

secondary data by updating and supplementing the previous secondary data collection for this 

study. As needed, ERG will gather information on the following: 

Current, relevant technical publications that describe the mercury waste 

generated (and their source) at dental facilities and their discharge of 

mercury and other amalgam filling metals (i.e., copper, silver, tin, and 

zinc) to POTWs; 

Current information on possible treatment solutions (i.e., amalgam 

separators and polishing systems) for dentists to reduce mercury from the 

wastewater and their effectiveness; and

Current implementation costs for technologies to reduce mercury and 

other metal discharges at dental facilities.

2.3.2 Secondary Data Activities Supporting Dental Amalgam ELG

ERG will collect and use secondary data to support the Dental Amalgam ELG, 

including preparing materials for outreach meetings, providing general technical support to EPA 

in preparing presentations, internal briefings, conducting technical analyses (e.g., determining 

technology effectiveness and costs, profiling and subcategorizing the dental industry, and 

calculating loadings), and drafting a technical development document. 

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

The primary objectives of this QAPP are to ensure that: 

1. Data generated and collected are of the quality necessary for EPA to 

develop the Dental Amalgam ELG; and

2. The underlying data and results of the analyses of these data are 

documented and of the type, quality, transparency, and reproducibility 

needed. 

ERG is supporting EPA in secondary data collection activities. The criteria that 

ERG will use to evaluate the quality of secondary data collected are described in this section. 

2.4.1 Literature and Other Information Search and Review

As explained above, the primary information ERG will be collecting is 

technology performance and cost data. Based on EPA’s previous study, EPA is focusing its 

technology evaluation on amalgam separators. Under Work Assignment 8-36 of Contract No. 

68-C-02-095, ERG amassed available amalgam separator effectiveness and cost information 

from vendors in the U.S. Similarly, ERG collected information about amalgam separator 

effectiveness and costs and information from other sources such as studies conducted for the 
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National Association of Clean Water Agencies (NACWA) and the American Dental Association 

(ADA). Information for the industry profile includes publicly available sources, such as Census 

information and those sources indicated in Section 1.3.

Previously collected data from such sources has been through public review and 

comment. As such, it has already been validated. EPA will use such data if it remains current 

(meets currency criteria described in Table 2-1). The criteria ERG will use to evaluate the quality 

of additional information collected during literature reviews are summarized in Table 2-1 along 

with acceptable values for each criterion. ERG will only use sources that meet these criteria. 

Table 2-1. Literature Review Data Acceptance Criteria

Acceptance Criterion: 

Literature Review Description/Definition Specification

Currency (up to date) Does the information reflect 

current conditions?

Year of publication (or presentation, if a paper presented 

at a conference). 

For amalgam separator and other treatment system 

effectiveness –

Priority: 2005 or after

For industry profile (number of dental offices and 

number currently using amalgam separators) – Priority: 

2008 or after

Amalgam Separator 

Effectiveness

Does the information reflect 

an evaluation conducted in 

according with established 

standards, such as ISO or 

ANSI?

Effectiveness was evaluated in accordance with 

protocols established in ISO, ANSI, or other established 

standard.

Accuracy/Reliability Is the information reported 

true? Is the scientific work 

clearly written so that all 

assumptions and 

methodologies can be 

identified?

Government publication (U.S., state)

For academic researcher:

Publication in peer-reviewed journal

Presentation at professional technical conference

For vendor researcher or ADA or NAQWA:

Publication in peer-reviewed journal

For other sources (not peer-reviewed or published), ERG 

will discuss the use of these sources with the EPA WAM 

to determine its accuracy/reliability for use.

2.4.2 Amalgam Separator Technology Costs

Under Work Assignment 8-36 of Contract No. 68-C-02-095, ERG collected

information about the costs for dental facilities to install and operate amalgam separators and 

other treatment technologies including waste handling costs. Because EPA is not conducting an 

ICR for this rulemaking, ERG obtained current (e.g., 2010 - 2011) cost information from 

equipment from no more than nine vendors that serve dental facilities. Any cost data used for the 

ELG analysis will be scaled to 2010 year dollars using the Means Construction Index or other 

standard index. The criteria ERG used to evaluate the quality of amalgam separator technology 
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cost information are summarized in Table 2-2 along with acceptable values for each criterion. 

ERG will only use sources that meet these criteria to calculate costs. 

Table 2-2. Treatment Technology Cost Data Acceptance Criteria

Acceptance Criterion: 

Literature Review Description/Definition Specification

Currency (up to date) Does the information reflect 

current conditions?

Reference year must be available in order to scale costs 

to current (2010) dollars.

Requirement: 2005 or after

Meet requirements for 

cost estimates

Is the basis of the cost 

estimate known?

Source indicates what the cost includes, such as one-time 

costs for equipment purchase and installation, and/or ongoing operating and maintenance costs, including 

recycling of amalgam (annual costs).

Accuracy/Reliability Is the information reported 

true?

Obtained from a vendor who does business with dental 

facilities, dental trade association (ADA), or dental 

facility.

Comparability Are the costs comparable to 

costs provided by sources that 

meet these acceptance 

criteria?

Comparable to costs obtained from other vendors and 

from studies (within 25% variability from one another).

If only one vendor’s data are available, ERG will consult 

with the EPA WAM to determine data use.

2.4.3 Amalgam Separator Technology Cost Estimates

Under Work Assignment 8-36 and Work Assignment 9-36 of Contract No. 68-C02-095, ERG estimated capital and annual operation and maintenance costs for the affected 

dental facilities to install and operate amalgam separators and to recycle the amalgam. The 

criteria that ERG used to determine if the estimated costs are of the quality needed to support 

EPA’s Dental Amalgam ELG are summarized in Table 2-3, along with acceptable values for 

each criterion. 

Table 2-3. Cost Estimate Quality Specifications

Acceptance Criterion: 

Cost Estimates Specification

Complete Cost information is available for all elements necessary to implement the 

amalgam separator technology (i.e. equipment, installation and operation).

Accurate (spreadsheet input) Cost spreadsheet inputs reflect design assumptions agreed on with project team, 

as double-checked by a reviewer.

Cost spreadsheet inputs reflect baseline condition assumptions or information 

agreed on with the project team at each facility as double checked by a reviewer.

Accurate (spreadsheet 

output)/Precision

Spreadsheet calculations are correct as double-checked by a reviewer and obtain 

the same result. 

Unit conversions are correct as double-checked by a reviewer.

Reasonable/Accurate Order-of-magnitude of costs is comparable to costs for similar installations at 

similar locations.

Cost trends follow the design basis trends (i.e., costs for large facilities are 

greater than the costs for small facilities).
Section No. 2.0

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2.5 Special Training/Certification (Element A.8)

Information and data collected during discussions with vendors or dental facilities

may be classified as Confidential Business Information (CBI). Therefore, ERG will train project 

staff in CBI-handling procedures as outlined in ERG’s CBI security plans. ERG will permit only 

staff demonstrating their understanding of CBI handling procedures by passing a written test to 

access CBI on this project. 

ERG will strictly adhere to all EPA procedures when handling industry CBI. ERG 

will manage all reports, documents, and other materials and all draft documents developed under 

this work assignment in accordance with the procedures set forth in ERG’s CBI security plans or 

their successor approved plans: 

Security Plan for Handling Confidential Business Information Under the 

Clean Water Act Contract EP-C-12-021, dated November 9, 2012 and 

approved by Ahmar Siddiqui, EPA’s Document Control Officer for this 

contract, on January 9, 2013; and 

Security Plan for Handling CWA Confidential Business Information 

Lexington, MA Office dated Oct. 25, 2005. 

2.6 Documents and Records (Element A.9) 

ERG has developed and instituted document control mechanisms for the review, 

revision, and distribution of QAPPs. Each QAPP has a signed approval form, title page, table of 

contents, and EPA-approved document control format (see header at the top of each page in this 

QAPP). During the course of the work assignment and/or project, the ERG WAM will circulate 

any revision to the approved QAPP to all ERG and EPA project staff as directed in Table 1. ERG 

will document the circulation of the revised QAPP to project staff with a signature page for the 

revision.

ERG’s WAM is responsible for designating an individual to maintain all project 

files, known as the index keeper. She is also responsible for ensuring that project team members 

document all data sources used. ERG will handle and store all information collected, generated, 

and analyzed during this project in a centralized record. This centralized record contains all data 

collected or accessed from other sources and documents analyses of data collected (e.g., 

literature reviews and database analyses). The contents of the record are indexed using a 

Microsoft Office AccessTM database. 
Section No. 3.0

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3.0 DATA GENERATION, ACQUISITION, AND USE

In its Requirements of Quality Assurance Project Plans (U.S. EPA, 2001), EPA 

identifies 10 elements to ensure that appropriate methods for data collection and generation are 

employed and documented. The 10 elements are: 

B.1 Sampling process design;

B.2 Sampling methods;

B.3 Sample handling and custody;

B.4 Analytical methods;

B.5 Quality control;

B.6 Instrument/equipment testing, inspection and maintenance;

B.7 Instrument/equipment calibration and frequency;

B.8 Inspection/acceptance of supplies and consumables;

B.9 Non-direct measurements; and

B.10 Data management.

Only elements B.9 and B.10 are applicable to ERG’s activities for this project. 

These elements are discussed below. To fulfill the work assignment direction, this section 

describes: 

1. The activities and procedures ERG will use to collect secondary data, how 

ERG will determine if the collected data meet the data acceptance criteria 

specified in Section 2.4.1 and 2.4.2, and how this determination will be 

documented;

2. What analyses ERG will perform using secondary data, how ERG will 

perform such analyses, how ERG will determine that the analyses and 

results meet project objectives, and how this determination will be 

documented; and

3. How ERG will manage project documents and data provided by vendors 

and industry. 

3.1 Non-Direct Measurements (Secondary Data) (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/or using the following types of secondary data:

Literature Review Data (Supporting Engineering Analyses); 

Amalgam Separator and other Treatment Technology Data; 

Industry Profile Data; and

Cost and Loads Estimate Data.

Sections 2.3 and 2.4 provide details on the source of the above data.
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3.1.1 Activities and Procedures for Collection and Use of Secondary Data

Collection of Secondary Data. ERG will update/supplement existing secondary 

data contained in EPA’s previous study and record from sources such as government 

publications and databases, scientific literature, industry published studies, and vendor quotes. In 

addition to published information, ERG will update/supplement amalgam separator technology 

cost information by contacting vendors by telephone and/or email, as needed. 

ERG staff will use the following procedures when collecting published secondary 

data:

ERG researchers will collect full content and bibliographic information on 

all newly 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 Dental Amalgam ELG Project File Index. Following 

the procedures detailed in the project file management plan, the index 

keeper will add the publication file to the Dental Amalgam ELG

Electronic Project File. ERG’s project file management plan is included in 

the Dental Amalgam ELG Project File Index, Document Control Number 

(DCN) DA00128.

ERG staff will use the following procedures when collecting secondary data via 

telephone and email contact.

ERG researchers will document all telephone contacts, questions asked, 

and responses using the Telephone Contact Report depicted in Figure 3-1. 

ERG researchers will save all email contacts as PDF files, so that they can 

be added to the electronic project file.

ERG researchers will ensure that telephone contact reports and email 

records are added to the Dental Amalgam ELG Project File.
Section No. 3.0

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Figure 3-1. Telephone Contact Report Form

Use of Secondary Data. ERG will prepare reports of the literature review 

supporting engineering analyses in formats directed by the EPA WAM. Formats could include 

annotated spreadsheets or technical memoranda, including tables of findings and bibliographic 

citations. Under Work Assignment 8-36 and Work Assignment 9-36 of Contract No. 68-C-02-

095, ERG used information collected about the dental industry to calculate baseline mercury and 

other metal loads to POTWs and potential loads reductions from implementing best management 

practices (BMPs) or control technologies (e.g., amalgam separators). Cost data were used to 

develop cost estimates and determine affordability, as discussed in Section 3.3 below. 

ERG used the methodology described in the Health Services Industry Detailed 

Study Report for Dental Amalgam (EPA-821-R-08-014) to calculate baseline loads and 

reductions in discharges for BMPs and technology options. Updated secondary data were used in 

this methodology, as appropriate. Underlying information or documentation such as ADA 

surveys will be included in the record supporting this rulemaking. The methodology uses the 

following calculation steps and assumptions:

Estimate total number of dentists: ERG used Census information in 

combination with industry studies (for example, ADA’s Survey and 

Economic Research on Dentistry) to estimate the total number of U.S. 

dentists and the number of U.S. dentists that may potentially remove 

mercury amalgam filling or place new mercury amalgam fillings.

Project No.: DISTRIBUTION

Page 1 of 1 

Project Name: 

TELEPHONE CALL 

RECORD

 Outgoing Call

Date: Time: 

Company Name: Contact Name: 

Phone No.: 

Name: 

GENERAL SUBJECT : 

TOPICS DISCUSSED AND ACTION TAKEN
Section No. 3.0

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Determine mercury and other metal discharges from amalgam restorations 

and amalgam removals: Under Work Assignment 8-36 of Contract No. 

68-C-02-095, ERG estimated the total number of amalgam restorations 

and removals typically performed in one year based on statistics from 

technical literature approved by the EPA WAM (for example, ―An 

Assessment of Mercury in the Form of Amalgam in Dental Wastewater in 

the United States.‖ Water, Air and Soil Pollution) ERG then determined

the amount of mercury typically released to wastewater per amalgam 

restoration or removal based on information from technical literature.

Determine Baseline Mercury and Other Metal Loads to POTWs: ERG 

used data collected for the industry to determine the number of dentists 

that currently have mercury controls in place and the mercury and other 

metal removals associated with these technologies. Control technologies 

include polishing systems, amalgam separators, chair-side traps, and 

vacuum pump filters, and may also include BMPs. Dental facilities were

grouped based on the control technology, BMP, or combination of control 

technologies and BMPs, in place. ERG calculated the baseline loads as 

follows:

Baseline Metal Load to POTWs(lb/yr) = [# of Dentists] * [Metal Released 

from Amalgam Restorations and Removals (lb/yr)]*(1-[Percent Removal 

for Control Technology or BMP])

Calculate mercury and other metal load reductions for technology options: 

ERG calculated mercury and other metal load reductions for technology 

options. Technology options include installation of amalgam separators or 

other treatment technologies. ERG calculated the new mercury and metal 

(i.e., copper, silver, tin, and zinc) loads using the same equation for 

baseline loads, shown above; however, all applicable dental facilities now 

achieve removals associated with the chosen technology option and will 

apply the percent removal for that option. ERG determined the treatment 

effectiveness of the options based on secondary data, which ERG 

collected from vendors and technical literature.

Determine mercury and other metal reductions in POTW effluent: ERG 

calculated the mercury and other metal reductions for implementing 

control technologies by applying POTW removal efficiencies to the 

baseline and post-change loads. ERG applied removal efficiencies from 

EPA’s Fate of Priority Pollutants in Publicly Owned Treatment Works

(EPA 440/1-82/303). 

3.1.2 QC Activities Related to Collection and Use of Secondary Data

Collection of Secondary Data. ERG will determine if collected secondary data 

meet the data acceptance criteria specified in Sections 2.4.1 and 2.4.2 by using the check lists 

found in Appendix A:
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Literature Review Data Quality Check List; and

Amalgam Separator Technology Cost Data Quality Check List.

ERG researchers will complete these checklists in a Microsoft AccessTM database 

form. The completed checklists will be maintained in a bibliographic database that will be

provided to EPA upon request. The database will be retained in the project file to document that 

ERG evaluated the quality of the collected secondary data.

Use of Secondary Data. Under Work Assignment 8-36 and Work Assignment 9-

36 of Contract No. 68-C-02-095, ERG used secondary data to develop an industry profile, 

determine effectiveness of amalgam separators, estimate pollutant loadings reductions and

calculate costs for dental facilities to implement amalgam separator technologies and polishing 

systems. ERG may also use the data to prepare materials for outreach meetings, provide general 

technical support to EPA in preparing presentations, internal briefings, and to draft a technical 

development document. ERG will plan and document review of any materials developed using 

secondary data. The ERG WAM (or other reviewer) will verify that the data sources used meet 

quality specifications by reviewing the associated data quality check lists as discussed in Section 

4.2 below. The deliverable review will be documented in a sign off sheet. An electronic copy of 

the sign off sheet will be retained in the project network area to document that the review 

occurred. 

3.2 Data Management (Element B.10) 

This section describes how ERG will manage project data.

3.2.1 Project File Management and QC Activities

ERG is using a project file management plan for this project that was adapted 

from similar plans prepared for other work assignments on Contract No. 68-C-02-095. This plan 

provides detailed instructions for developing a project index and a system to manage information 

collected on this project. This system is compatible with the needs of the Federal Docket 

Management System (FDMS). The ERG WAM has assigned a project team member (the ―index 

keeper‖) the responsibility of maintaining the file index and filing documents in the electronic 

project file. 

The Dental Amalgam ELG Project File Management Plan includes detailed 

procedures for ensuring the quality of the project file and docket and for quality checks that will 

be performed during the assembly of the public and CBI dockets. ERG will report the following 

activities to EPA in our monthly QA activity report: 

Quarterly project file review of index for completeness and accuracy; and 

Final Project file review conducted during docket assembly. 

3.3 Amalgam Separator Technology Costing 

Under Work Assignment 8-36 and Work Assignment 9-36 of Contract No. 68-C02-095, ERG estimated costs for the affected dental facilities to perform BMPs and to install and 
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operate treatment technologies to control discharges of mercury and other metal pollutants to the 

POTW. 

3.3.1 Development of Cost Estimates

ERG developed several spreadsheets to estimate costs for dental facilities to meet 

ELG requirements for BMPs, amalgam separators, and other treatment technologies as 

determined by the EPA WAM. ERG checked spreadsheet data entry and calculations as 

discussed above in Table 2.3 and document these checks in a separate table in the spreadsheet 

workbook. Cost information was compared to the quality requirements specified in Table 2-3. 

When changes are made to a spreadsheet, ERG will:

Assign a unique name and number to the revised version of the 

spreadsheet; 

Maintain a historical file of the spreadsheet(s); and 

In a separate QA worksheet (spreadsheet) in the workbook (notebook) 

itself, log the changes made to the different versions and explain what was 

revised, why it was changed, the date the revision was made, and by 

whom. 

Costs may differ among dental facilities, for example amalgam separator costs 

may be less expensive for smaller sized dental facilities (defined by number of chairs) than for 

large dental facilities. Where available, ERG will collect cost information that is based on facility 

size (e.g., # of chairs) so that costs can be evaluated for a range of dental facility size. At EPA’s 

direction, ERG developed costing approaches for each of the options provided by the EPA 

WAM, and discussed the costing approach, use of cost spreadsheets, and other costing 

documentation with the EPA WAM. ERG developed the spreadsheets to reflect the planned 

approach agreed on by the project team, completed cost estimates for the affected dental 

facilities, and provided estimated capital and operating and maintenance costs to EPA. The 

costing approaches will be generally included in the QAPP when those discussions are made and 

outputs documented. ERG’s specific costing approaches will be documented in the TEDD for 

this project.

ERG anticipates that some vendors may claim their cost information to be CBI. In 

that case, as appropriate, calculations, including estimated costs, dependent on CBI will be 

managed as CBI until EPA determines that facility-specific information has been adequately 

masked.

3.3.2 QC Activities Related to Development of Cost Estimates

Evaluating and Documenting Cost Estimate Quality. If further costs estimates are 

generated, an ERG technical reviewer will verify the appropriateness of the technical approach 

and verify that original data are correctly input into the spreadsheet as specified in Table 2-3. 

ERG will use standard engineering references to document that calculations are appropriate. 

ERG will review any constants used for appropriateness, will check that units are converted 

properly, and will document and check the equations used in the costing spreadsheets. The 

spreadsheet reviewer will provide the spreadsheet developer with a written summary of the data 
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checked, any errors or problems found, any recommendations for revisions, and ensure that any 

revisions are incorporated. The spreadsheet review will be documented using the deliverable 

review sign off sheet provided in Appendix A.

Before ERG delivers the cost estimates to EPA, ERG will compare the estimated 

costs to the quality specifications listed in Table 2-3. ERG will document the results of this 

comparison in writing to the EPA WAM. 
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4.0 ASSESSMENT AND OVERSIGHT ELEMENTS

This section describes the methods ERG will use to assess that this QAPP is 

implemented as prescribed. 

4.1 Assessments and Response Actions (Element C.1)

ERG will subject all work conducted on this project to technical review. 

Technical review is a documented critical review of work. ERG’s WAM will conduct this 

review. In addition, reports and memoranda to the record will be reviewed by a senior-level 

engineer (for engineering activities) not directly involved with the project. All deliverables will 

subsequently be reviewed by the EPA WAM. ERG will document all reviews of project 

deliverables and maintain copies of deliverable review sign off sheets (provided in Appendix A)

in the project QA files.

ERG’s Project QA Coordinator for this project or her designee will assess the 

implementation of QA/QC procedures on this project as follows: 

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

Audit project files to ensure and verify the following: 

— That project staff have developed QC procedures and that these 

procedures are used; and

— That project staff are documenting these QC activities by completing 

checklists, review spreadsheet, and other project-specific forms.

Documentation of any Project QA Coordinator audits will be included in the project QA files

and reported to the WAM as described below. 

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)

ERG will describe QA activities conducted for all deliverables, such as summary 

memos, when such documents are delivered to EPA. These descriptions will be included in the 

document. 

Additionally, ERG will provide the EPA WAM with monthly reports on the status 

of QA activities. These 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; 

Identification of any deviations from the QAPP; and
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Identification of problem resolution and/or corrective actions taken during 

the reporting period, if any. 

Table 4-1 provides a list of the QA/QC activities performed during the reporting period as part of 

the implementation of the work assignment that ERG will report to the EPA WAM. 

Table 4-1. Reporting QA/QC Activities

Data Generation, 

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

Non-direct 

Measurements 

(Secondary data)

The number of secondary data collection sources reviewed that meet the criteria, an

indication if this number is sufficient, and the associated reasoning.

Development of 

Technical Analyses

Spreadsheet (template) review.

Spreadsheet (loaded) review.

Quality review.

In addition, any quality deficiencies detected by technical reviewers or the Project 

QA Coordinator will be communicated, in writing, to the ERG WAM and should be captured in 

the QA report as well. The ERG WAM is responsible for ensuring that appropriate corrective 

action is taken and reported to the Project QA Coordinator. ERG will include any reports of 

corrective actions in the project QA files.
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5.0 DATA VALIDATION AND USABILITY ELEMENTS

ERG will compare the quality of collected data and analyses to quality objectives 

described in Section 2.4 and report our findings to the EPA WAM to enable him/her to 

determine whether the collected and analyzed data are of sufficient quality for use in the 

development of the Dental Amalgam ELG. This subsection discusses how ERG will review data 

quality and report the results. 

5.1 Data Review, Verification, and Validation; and Validation Methods 

(Elements D.1 and D.2)

Data verification means confirmation that data quality specifications have been 

met. Verification of a result (for example, estimated costs) means confirmation that the results 

are of the type, quality, transparency, and reproducibility needed. This section summarizes how 

ERG will determine that data and results meet quality specifications and how ERG will 

document data quality review occurred. 

Technical Data Collection and Use. Table 5-1 provides a summary of the 

procedures ERG will use to determine that data used and results generated on this project meet 

quality specifications. 

Table 5-1. Summary of Data and Results Quality Verification 

Data Source and 

Use Specification

How ERG Will Determine That 

Data Meet Quality Specifications

How ERG Will Document Data 

Quality Review

Literature review 

(engineering)

Table 2-1 Compare data source to Table 2-1

requirements

Literature Review Data Quality 

Check List

Cost Data Table 2-2 Compare data source to Table 2-2

requirements

Amalgam Separator Technology 

Cost Data Quality Check List

Cost Estimates Table 2-3 Spreadsheet reviews; Compare to 

Table 2-3 requirements

Summary memo delivered to EPA

Project File Project File 

Plan

Comparison to FDMS docket 

requirements

Preparation of project file and 

project file index that meet FDMS 

requirements.

Quarterly review of project file 

index for completeness and 

accuracy of metadata.

5.2 Reconciliation with User Requirements (Element D.3) 

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 (U.S. EPA, 2002).
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6.0 REFERENCES

ERG, 2012. Security Plan for Handling Confidential Business Information Under the Clean 

Water Act Contract EP-C-12-021. November 9, 2012.

ERG, 2005. Security Plan for Handling CWA Confidential Business Information, Lexington, MA 

Office, October 25, 2005.

ERG, 2014. Environmental Engineering Support for Clean Water Regulations Programmatic 

Quality Assurance Project Plan (PQAPP). October 2013.

U.S. EPA, 2001. U.S. Environmental Protection Agency. EPA Requirements for Quality 

Assurance Project Plans QA/R-5. EPA/240/B-01/003. Office of Environmental Information. 

March 2001. 

U.S. 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. October 2002. 
Appendix A

CHECK LISTS

AND SIGN-OFF SHEETS
Literature Review Data Quality Check List

Reference Citation:

DCN

Reviewer Name: 

Date Reviewed: 

Source Usability Determination:

____meets quality specifications

____does not meet quality specifications

Specification Value Comments

Year of publication (or presentation, if a paper presented at 

a conference) 

Priority: 2005 or after.

Consider: 2000 or after.

Demonstration Status

Priority: full-scale processes (i.e., amalgam separator) in 

commercial use.

Consider: processes demonstrated in pilot scale. 

Geographic Scope

Priority: processes used in the U.S.

Consider: processes used outside the U.S.

Type of Publication

Government publication (U.S., state, etc.)

For academic researcher:

Publication in peer-reviewed journal

Presentation at professional technical conference

For vendor, ADA, or NAQWA researcher:

Publication in peer-reviewed journal
Amalgam Separator Technology Cost Data Quality Check List

Cost Information Source:

DCN

Reviewer Name: 

Date Reviewed: 

Source Usability Determination:

____meets quality specifications

____does not meet quality specifications

Specification Value Comments

Costs are current (e.g., 2010 – 2011).

Obtained from a vendor who does business with dental 

facilities in the U.S..

Within +/- 33% of other sources identified in previous study. 
Deliverable Review Sign-off Sheet

Charge No.: Date:

DeliverableTitle/Draft No.:

Original Author:

Client Due Date:

CONTAINS CBI YES NO

WAM/Designee Signature

REVIEW OF SUPPORTING DOCUMENTATION (applicable to deliverables based on data analysis or calculations):

Supporting Documentation Checked: Tech. Reviewer Date:

Complete, Organized, Checked Documentation Provided: WAM Date:

Review Sequence

Technical Review: Scheduled Review:

Date:

Date:

WAM Review: Scheduled Review:

Date:

Date:

Sr. Technical Review: Scheduled Review:

Date:

Date:

Peer Review: Scheduled Review:

Date:

Date:

PjM Review: Scheduled Review:

Date:

Date:

Project QA Coordinator: Scheduled Review:

Date:

Date:

Editorial Review: Scheduled Review:

Date:

Date:

Review Comments Resolution/Incorp: Scheduled Review:

Date:

Date:

Client Comments Incorporated: Scheduled Review:

Date:

Date:

Distribution Instructions: 

Network file location: