# 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

- 3 6Revision No. 2

Date: July 31 , 2014 Page ii of v

ii 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 DateRevision No. 2

Date: July 31

, 2014 Page iii of v

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, 201 1

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

- C

12

- 021including existing data collection, evaluation, analysis, and use.

Comments Received No comments

Comments Addressed No comments

Approval 9 /4/2014Revision No. 2

Date: July 31 , 2014 Page iv of v

iv 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 N o. 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.Revision No. 2

Date: July 31

, 2014 Page v of v

v TABLE OF CONTENTS

Page

1.0 D ISTRIBUTION (E LEMENT A.3)

................................ ................................ ......................... 1

- 1

2.0 P ROJECT M ANAGEMENT E LEMENTS

................................ ................................ ................. 2

- 1

2.1 Project Organization (Element A.4)

................................ ................................ .... 2

- 1

2.2 Problem Definition/Background (Element A.5)

................................ .................. 2

- 2

2.3 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 D ATA G ENERATION

, A CQUISITION

, AND U SE

................................ ................................ ... 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 A SSESSMENT AND O VERSIGHT E LEMENTS

................................ ................................ ........ 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 D ATA V ALIDATION AND U SABILITY E LEMENTS

................................ ............................... 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 R EFERENCES

................................ ................................ ................................ ..................... 6

- 1

Appendix A: CHECK LISTS AND SIGN

- OFF SHEETSRevision No. 2

D ate: July 31, 2014 Page vi of v

LIST OF TABLES

Page

Table 1

- 1. QAPP Distribution List

................................ ................................ .............................. 1

- 1

Table 2

- 1. Literature Review Data Acceptanc e 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 Verifica tion

................................ ................... 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

- 3Section No. 1.0

Revision No. 2

Date: July 31, 2014 Page 1 of 1

1.0 D ISTRIBUTION (E LEMENT 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

- 10 35 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

K imberly

. Bartell @erg.comSection No. 2.0

Revision No. 2

Date: July 31, 2014 Page 1 of 7

2.0 P ROJECT M ANAGEMENT E LEMENTS

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 ens ure 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 Sh eet; 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.

Elemen ts 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 responsi bilities 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, an d 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 proj ect, 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

Revision No. 2

Date: July 31, 2014 Page 2 of 7

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 r educe 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 tox ic element. Mercury

containing 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 a pproximately 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

Environmental Engineering 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 Betsy Bicknell EPA WA Manager

Damon Highsmith

Technical Reviewer
Mary Willett ERG Technical StaffSection No. 2.0

Revision No. 2

Date: July 31, 2014 Page 3 of 7

EPA began a study of this industry as part of its 2006 Effluent Gu idelines 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 se parators 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 de ntal amalgam separators as part of the Health Services Industry Detailed Study , in the spring of 20 08 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 co llection on amalgam separators, including costs for s eparators and polishing systems

, and developed a costing and load ing analyses spreadsheet . Under Work Assignment 9

- 36 of Contract No. 68

- C

- 02

- 095 , ERG provide d 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

- 0 21 , 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 oth er 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 b ases 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

literatu re pertaining to dental amalgam and its d ischarge

, such as information obtained from

vendor s 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 Bu siness 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

Revision No. 2

Date: July 31, 2014 Page 4 of 7

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 :

C urrent, 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 ;

C urrent information on possible treatment solutions (i.e., amalgam separators and polishing systems) for dentists to reduce mercur y from the

wastewater and their effectiveness ; and

C urrent 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 effectivene ss 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 qualit y 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

- 0 95

, ERG amass ed available amalgam separator effectiveness and cost information from vendors in the U.S. Similarly, ERG collect ed information about amalgam separator

effectiveness and costs and information from other sources such as studies conducted for th eSection No. 2.0

Revision No. 2

Date: July 31, 2014 Page 5 of 7

National Association of Clean Water Agencies (NACWA) and the American Dental Association (ADA)

. Information for the industry profile include s 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 eval uate 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 Cr iteria

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 : 200 5 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/reliabili ty for use.

2.4.2 Amalgam Separator Technology Costs

Under Work Assignment 8

- 36 of Contract No. 68

- C

- 02

- 095

, ERG collect ed

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

other treatment technologies including waste handling costs. Because EPA is not conducting an ICR for this rulemaking, ERG obtain ed current (e.g., 2010

- 201 1 ) cost information from equipment from no more than nine vendors that serve dental facilities

. Any cost data used for the ELG analysis wi ll be scaled to 2010 year dollars using the Means Construction Index or other

standard index. The criteria ERG use d to evaluate the quality of amalgam separator technologySection No. 2.0

Revision No. 2

Date: July 31, 2014 Page 6 of 7

cost information are summarized in Table 2

- 2 along with acceptable values for each c riterion. 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 : 200 5 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 on

going 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

- C

02

- 095

, ERG estimate d 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 use d 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 C ost 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 reviewe r 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 basi s trends (i.e., costs for large facilities are

gr eater than the costs for small facilities ).Section No. 2.0

Revision No. 2

Date: July 31, 2014 Page 7 of 7

2.5 Special Training/Certification (Element A.8)

Information and data collected during discussions with vendors or dental facilities may be classified as Confiden tial Business Information (CBI). Therefore, ERG will train project

staff in CBI

- handling procedures as out lined 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 E RG’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, ti tle 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 EP A 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 contain s 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

Revision No. 2

Date: July 31, 2014 Page 1 of 7

3.0 D ATA G ENERATION , A CQUISITION , AND U SE

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 Analytic al 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 s uch 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

- D irect Measurements (Secon dary 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 anothe r 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 Est imate Data

.

Sections 2 .3 and 2 .4 provide details on the source of the above data.Section No. 3.0

Revision No. 2

Date: July 31, 2014 Page 2 of 7

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 previo us 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 informa tion 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 publicati ons, including ―date accessed‖ for information

collected from the Internet. E RG researcher s will save w eb 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 f ile 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

Revision No. 2

Date: July 31, 2014 Page 3 of 7

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 use d information collected about the dental industry to calculate baseline mercury and

other metal loads to POTWs and potential loads reductions from implementing best manageme nt 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 use d the methodology described in the Health Services Industry Detail ed 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 su ch 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 use d Census information in combination with industry studies (for exam ple, ADA’s Survey an d 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.Section No. 3.0

Revision No. 2

Date: July 31, 2014 Page 4 of 7

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 estimate d 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 determine d the amount of mercury typically released to wastewate r per amalgam

restoration or removal based on information from technical literature.

Determine Baseline Mercury and Other Metal Loads to POTWs : ERG

use d data collected for the industry to determine the number of dentists that currently have mercury control s in place and the mercury and other

metal removals associated with these technologies. Control technologies

include polishing system s
, 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 calculate d the baseline loads as

follows:

Baseline M

etal Load to POTWs(lb/yr) = [# of Dentists] * [ M etal 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 calculate d mercury and other metal load reductions for technology options. Technology options include installation of amalgam separators or other treatment technologies . ERG calculate d 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 perce nt removal for that option. ERG determine d the treatment effectiveness of the option s based on secondary data, which ERG

collect ed from vendors and technical literature

.

Determine mercury and other metal reductions in POTW effluent : ERG

calculate d 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 effi ciencies 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 :Section No. 3.0

Revision No. 2

Date: July 31, 2014 Page 5 of 7

Literature Review Data Quality Check List; and Amalgam Separator Technolo gy Cost Data Quality Check List.

ERG researchers will complete these checklists in a Microsoft Access TM 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 use d 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 sourc es 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 proj ect 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 wa s adapted from similar plans prepared for other work assignments on Contract No. 68

- C

- 02

- 095 . This plan provide s detailed instructions for developing a project index and a system to manage information collected on this project. This system is compatible wi th 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 P roject File Management Plan include s 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 EP A 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 Assignm ent 9

- 36 of Contract No. 68

- C

02

- 095

, ERG estimate d costs for the affected dental facilities to perform BMPs and to install andSection No. 3.0

Revision No. 2

Date: July 31, 2014 Page 6 of 7

operate treatment technologies to control discharges of mercury and other metal pollutants to the

POTW

.

3.3.1 Development of Cost Est imates

ERG develop ed several spre adsheets 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 check ed 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 change s 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 an d 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 cha irs) 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 develop ed costing appro aches for each of the options provided by the EPA WAM, and discuss ed the costing approach

, use of cost spreadsheets, and other costi ng documentation with the EPA WAM . ERG develop ed the spreadsheets to reflect the planned approach agreed on by the project t eam , complete d cost estimates for the affected dental facilities, and provide d 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 documente d. 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, c alculations, 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, a n 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 a ppropriate. 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 wi th a written summary of the dataSection No. 3.0

Revision No. 2

Date: July 31, 2014 Page 7 of 7

checked, any errors or problems found, any recommendations for revisions , and ensure that any revisions are incorp o rated

. The spreadsheet review will be documented using the deliverable review sign off sheet provided in App endix A.

Before ERG deliver s the cost estimates to EPA , ERG will compare the estimated costs to the quality sp ecifications listed in Table 2

- 3 . ERG will document the results of this comparison in writing to the EPA WAM.Section No. 4.0

Revision No. 2

Date: July 31, 2014 Page 1 of 2

4.0 A SSESSMENT AND O VERSIGHT E LEMENTS

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 subsequent ly 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 w ill 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 procedure s 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 pro ject 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 ac tivities 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;

Id entification of any problems encountered; Identification of any deviations from the QAPP; andSection No. 4.0

Revision No. 2

Date: July 31, 2014 Page 2 of 2

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 S preadsheet (template) review.

S preadsheet (loaded) review.

Q uality 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 Coo rdinator. ERG will include any reports of corrective actions in the project QA files.Section No. 5.0

Revision No. 2

Date: July 31, 2014 Page 1 of 1

5.0 D ATA V ALIDATION AND U SABILITY E LEMENTS

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 confirmat ion 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 determi ne 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 Spreadshe et 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 ident ifications 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 Inf

ormation Quality Guidelines ( U.S. EPA, 2002).Section No. 6.0

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Date: July 31, 2014 Page 1 of 1

6.0 R EFERENCES

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 Disse minated by the Environmental Protection Agency. EPA/260R

- 02

- 008. October 2002.A ppendix A

CHECK LISTS

AND SIGN

- OFF SHEETSLiterature 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 journalAmalgam 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 cur rent (e.g., 2010

– 201 1 ).

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: