## Support for Regulatory Determination 3 Expert Reviews

Contract EP

- C

- 08

- 005

Work Assignment (WA) 4

- 19

Meeting Summary

October 26 th and 27 th 2011
Washington D.C.

Prepared for: Ali Arvanaghi

– WAM US EPA, Room 2209F 1200 Pennsylvania Ave., NW Mail Code 4607M Washington, DC 20460 E

- mail: arvanaghi.ali@epa.gov

Prepared by: IntelliTech Systems, Inc. Timothy E. Soward , MPH Technical Project Manager tim.soward@itsysteminc.com

Hema Patel, Ph.D. Program Manager hema.patel@itsysteminc.com



### December 20112 

## Table of Contents

Introduction

................................ ................................ ................................ ............................ 3 1. Background

................................ ................................ ................................ ............................ 3 2. Expert Review Process

................................ ................................ ................................ .......... 4 3.

3.1 Expert Reviewers

................................ ................................ ................................ .......................... 4

3.2 Review Charge

................................ ................................ ................................ ............................... 4 Expert Re view Meeting

................................ ................................ ................................ .......... 5 4.

4.1 Welcome and Introduction

− James McFarland, IntelliTech Systems, Facilitator

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

4.2 Background on Regulatory Determination Process

................................ ................................ ...... 7

4.3 Background on Drinking Water Strategy

................................ ................................ ...................... 7

4.4 Background on Regulatory Determination 3 Process

................................ ................................ ... 7

4.5 Expert Review Discussion of individual Charge Questions

................................ ........................... 7

4.6 Regulatory Determination

– Phase 1: Data Availability

................................ ................................ 8

4.7 Regulatory Determination

– Phase 2: Data Evaluation

................................ ............................... 11

4.8 Regulatory Determination

– Phase 3: Regulatory Determination Assessment

.......................... 16

4.9 Regulatory Determi nation

– Overall Charge Questions Comments

................................ ........... 18

4.10 Key Summary Comments from the Expert Reviewers

................................ ................................ 19
Annex

................................ ................................ ................................ ................................ .......... 213 

## Introduction 1.

The primary goal of this Work Assignmen t ( WA ) was to provide the a gency with an unbiased expert review of the approach used for Regulatory Determination 3 (RD 3)

. This work consisted of a paper review of EPA’s October 2011 Draft Document, Protocol for the Regulatory Determination 3 , b y seven expert reviewers. 1 The reviewers were chosen out of a list of over 20 potential candidates. Reviewers were selected based upon their availability and m ore importantly their experience in one or more of the following areas of expertise: evaluation of health and/ or drinking water occurrence /exposure information, state drinking water or public water system perspective, and/or some familiarity with the RD 3 process ( including the Candidate Contaminant L ist). A draft list of candidates was submitted to th e EPA Work Assignment Manager (WAM) by IntelliTech Systems Inc. along with their resumes or CVs, and how they were identified.

The first expert review consisted of a paper review of the Protocol for the Regulatory Determination 3 document. The reviewers were given a list of ten charge questions to which they were asked to provide written comments. Intellitech facilitated two teleconferences between the expert reviewers and EPA to provide the experts with (a) an overview of the R D 3 process and the ten ch arge questions , and (b) a forum for the experts to ask questions and make comments specific to the charge of the expert reviewers . After the written comments were received and compiled by IntelliTech Systems, a meeting was held at EPA Headquarters in Washington D.C. on October 26 th and 27 th of 2011 to allow the experts to discuss the RD 3 process and to provide EPA with constructive comments. The expert reviewers were able to review and edit their original written comments following the October 26 th and 27 th meeting ( if they chose to do so)

.


## Background 2.

The Safe Drinking Water Act (SDWA), as amended in 1996, directed the Environmental Protection

a gency (EPA) to publish a list of contaminants referred to as the Contaminant Candidate List ( CCL) to assist in pr iority

- setting efforts. The SDWA also directs EPA to select five or more contaminants from the CCL and determine whether or not to regulate these contaminants with a National Primary Drinking Water Regulation (NPDWR). This process is called Regulatory Dete rmination ( RD ). This work assignment (WA 4

- 19) required IntelliTech Systems Inc. to perform an expert review on the Regulatory Determination 3 Process Document , the Protocol for the Regulatory Determination 3

.

1 The final version of the Protocol is available in the RD 3 docket as : USEPA. 2014. Protocol for the Regulatory Determination 3. Including Appendices A

- F. April 2014. EPA Publication # 815

- R14

- 005.4 Expert review is intended to provide a focuse d, objective evaluation of a document or approach. EPA addresses the criticisms, suggestions, and new ideas provided by the expert reviewers prior to redrafting the reviewed work. Comprehensive, objective technical reviews contribute to good science and

re gulatory acceptance of precedent

- setting methodologies and /or controversial issues within the scientific and regulated communities.
An independent expert reviewer is an expert who did not provide substantial contributions or consultation to the work produc t development. Independent expert reviewers are expected to be objective and free from institutional, ideological, or technical bias regarding the issues under review. Expert reviewers should represent a range of technically legitimate points of view (cons idering the industrial, academic, governmental, and environmental communities) that have the expertise to provide a balanced scientific or technical evaluation of the work.



## Expert Review Process 3.

3.1 Expert Reviewers
The seven reviewers selected for the RD 3 E xpert R eview included :

Damon Guterman, Massachusetts Department of Environmental Protection Brian Ramaley, P.E., Newport News Waterworks Gary Rogers Lynch, Park Water Company Kate Sande, Minnesota Department of Health Phil ip Singer, Ph.D., University of N orth Carolina at Chapel Hill Mary Skopec, Ph.D., Iowa Department of Natural Resources Lynn Thorp, Clean Water Action



### 3.2 Review Charge
The expert reviewers were tasked with reviewing EPA’s October 2011 Draft Document, Protocol for the Regulatory Determination 3 . EPA prepared ten specific questions that they asked the e xpert reviewers to consider in reviewing the draft document. These ten questions , which constitute the Expert Reviewer ’s Charge , are as follows:

1. Is the approach and evaluation described in the R egulatory Determination 3 Protocol clear, consistent and transparent?

2. Does the a gency’s Regulatory Determination 3 P rotocol sufficiently explain EPA’s interpretation and evaluation of the first and second SDWA statutory criteria used for making a regulatory determination? Note: The third statutory criterion is in the sole judgment of the Administrator.

3. Does the overall Regulatory Determination 3 process described in the P rotocol identify and focus on contaminants of greatest public health concern t o be referred to the Administrator for an evaluation5 of the third statutory criterion ( i.e., to determine whether or not regulation presents a meaningful opportunity for health risk reduction for persons served by public water systems)?

4. Are the data availa bility criteria used in Phase 1: Data Availability appropriate for identifying contaminants with sufficient health and occurrence data/information to be placed on the “short list” to proceed to Phase 2: Data Evaluation ?

5. Are the information and factors cons idered in the Phase 2: Data Evaluation appropriate and sufficient for selecting contaminants of “greatest public health concern” to proceed to Phase 3: Regulatory Determination Assessment ?

6. Are the information and factors considered in the Phase 2: Data Eva luation appropriate and sufficient for selecting contaminants that indicate “no to low potential for public health concern” to proceed to Phase 3: Regulatory Determination Assessment ?

7. Does the P rotocol adequately explain the rationale for those contaminant s that do not proceed through the process (i.e., through Phases 1 and 2)?

8. In Phase 3: Regulatory Determination Assessment , has the a gency used the best available science and integrated the data appropriately to evaluate the first and second statutory crite ria for each of the contaminants selected for Regulatory Determination 3?

9. In the evaluation of the first and second statutory criteria for Regulatory Determination 3, did the

a gency appropriately consider the available health effects on sensitive populatio ns?

10. Are there additional information or factors that should be considered in any of the three phases? Please explain why.



## Expert Review Meeting 4.

The Regulatory Determination 3 Expert Review Meeting convened in Washington, D.C. , at the U.S. EPA Office of Gr ound Water and Drinking Water. The meeting was scheduled for the afternoon of October 26, 2011, and a full day on October 27, 2011.
The following sections pr ovide a brief summary of overall comments and discussions among the RD 3 Expert Reviewers . This su mmary was prepared using written notes taken during the expert review meeting and compiled by EPA’s contractor, IntelliTech Systems, Inc. The summary was reviewed and supplemented with additional written notes recorded by EPA’s OGWDW staff.6 

### 4.1 Welcome and Introduction

− James McFarland, IntelliTech Systems, Facilitator
The meeti ng began with the expert r eviewers and EPA participants introducing themselves (see section 3.1 for the list of expert reviewers) . Though the expert reviewer s identified their p rofessional affiliations, all participants agreed that their attendance and input was based on their professional expertise and not as an advocate for a public water system, regulatory agency, or non

- profit group. Comments were noted as representing the ex pert reviewers own personal views and professional opinions. It was also noted that a ll information discussed during the expert review was confidential EPA internal deliberative information. Welcoming Comments

– Cynthia Dougherty, Director, USEPA Office of Ground 4.1.1 Water and Drinking Water , and Pamela Barr, Director, Standards and Risk Management Division, USEPA OGWDW Ms. Dougherty and Ms. Barr both expressed their thanks to the e xpert r eviewers for participating in this effort and spoke of this effort as a response to the Government Accountability Office (GAO) recommendations for improving the consistency, clarity and transparency in the process for identifying drinking water contaminants that pose the greatest public health concern under the Safe Drinking Water Act. The expert reviewers were asked to consider during the expert review meeting and in their submitted written comments whether EPA’s RD 3 Protocol is logical and adequately addresses GAO’s concerns and whether the RD 3 Protocol ( as documented ) has allowed the agency to identify those contaminants of greatest public health concern.
When asked by the expert reviewers how OGWDW intends to use the comments and review meeting output, Ms. Dougherty respond ed that the results of the expert review discussi ons would be shared with the Deputy Administrator.
Meeting Objectives and Ground Rules

– Meeting Facilitator 4.1.2
The expert reviewers w ere instructed that the purpose and objective for this RD 3 Expert Review Meeting , was to provide a forum for:

• EPA to present and summarize its program objectives of the Protocol for the Regulatory Determination 3 ;

• Expert r eviewers to discuss and clarify their written comments and exchange ideas that will help EPA improve the RD 3 Protocol document;

• EPA to respond to questions related to the RD 3 P rotocol and help clarify the thinking that went into the P rotocol approach; and

• Participants to i dentify any available information or data that the reviewers may know of that could help EPA improve the document.7 EPA reinf orced its objective that the meeting was intended to foster the exchange of information and not intended to foster debate regarding its RD 3 P rotocol approach or individual expert reviewers own personal opinions, but rather to gather information and techni cal perspectives through academic discussion of the issues. It was stated clearly that group consensus was not sought on any of the Expert Review Charge questions. Moreover , the primary purpose of the meeting was to have an open discussion of issues and ga ther information that would improve the RD 3 P rotocol document.

Expert r eviewers were further instructed that a written summary of the expert review meeting would be prepared (this document), but their submitted written comments would serve as their offi cial comments in response to each charge question. The reviewers were encouraged to revise their written comments as they deemed necessary based on the meeting discussions.



### 4.2 Background on Regulatory Determination Process Wynne Miller, Branch Chief, Standards and Risk Reduction Branch (SRRB), Standards and Risk Management Division (SRMD) within OGWDW, provided a brief presentation on the background on Regulatory Determination and other related regulatory processes (slides i ncluded in an Annex to this meeting summary ).



### 4.3 Background on Drinking Water Strategy
Zeno Bain, RD 3 Team Leader, Standards and Risk Reduction Branch (SRRB

- SRMD

- OGWDW), provided a brief overview of EPA’s Drinking Water Strategy and how that strategy compl ements the RD 3 Protocol (slides included in the Annex to this meeting summary )



### 4.4 Background on Regulatory Determination 3 Process
Zeno Bain, RD 3 Team Leader, SRRB

- SRMD

- OGWDW , provided a brief presentation describing the agency’s overall approach and conce pt for RD 3 (slides included in the Annex to this meeting summary ).



### 4.5 Expert Review Discussion of individual Charge Questions
The c harge questions were presented and discussed as they related to the three Phases of EPA’s RD 3 P rotocol . Some of the Charge q u e stions related to more than one o f the three phases and are repeated below with comments limited to the phase being discussed.

Each expert reviewer was provided an opportunity to summarize their comments in answering each of the ten Charge questions and to ask clarifying questions of EPA staff. The summary below captures the highlight of the e xpert r eviewer’s comments and EPA responses when those were sought.8 

### 4.6 Regulatory Determination

– Phase 1 : Data Availability Overview of OGWDW’s Phase 1 Approach

– Zeno Bain, RD 3 Team Leader, 4.6.1 OGWDW Zeno Bain presented a brief summary of Phase 1 ( Data Evaluation ) of the RD 3 Protocol (slides included in the Annex to this meeting summary ).
Expert Review Discussion of Phase 1 Charge Questions 4.6.2 Charge Question 4 : Are the data availability criteria used in Phase 1: Data Availability appropriate for identifying contaminants with sufficient health and occurrence data/information to be placed on the “short list” to proceed to Phase 2: Data Evaluation ?

The e xpert r eviewers acknowledged that significant effort was involved in identifying and evaluating occurrence and health assessment data sources. However, there appeared to be general agreement from the reviewers that the discussion could be clearer as to the basis for iden tifying and evaluating these data sources. The document was less clear in discussing the use of non

- national occurrence data, than when discussing the merits of using national data. When u sing non

- national data , the expert reviewers wanted examples of how they were evaluated or why the agency chose to use particular datasets over other data sets

. [ EPA acknowledged that the agenc y could increase transparency by giving examples for a selection of contaminants as to why they were not selected for further evalu ation in Phase 2 on the basis of the assessment of available data sources. ]
Select comments in response to this charge question include the following:

• One expert reviewer wanted greater clarity particularly on the use of non

- national data and any judgment that was applied in selecting or deselecting these data: “Is there a minim um level of scientific validity that determines whether a data set is valid or not ? Do not have a problem with the use of non

- national data, b ut what criteria or factors are used to select the data?”

• C oncern voiced about the use of some occurrence data which may lack transparency, inconsistent methodologies across states, and poor documentation regarding underlying values (e.g., raw vs. finished water errors )

.

• Add a listing of the he alth sources to the document (similar to the occurrence sources listed in the appendi ces ) , explain basis for the health data assessments used (i.e. , available vs. no assessment), and clarify if EPA and non

- EPA data sources are viewed differently.

• Clarify w hat is meant by a peer

- reviewed Health Risk Level (HRL) and whether an internal or external peer

- review is completed.9 • Provide additional footnotes on tables in appendices (especially A ppendix D of the P rotocol ) and in the document to improve the clarity of the discussion of data sources and results of each Regulatory Determination 3 Phase.

• Want to be clear we are not missing contaminants of concern, such as cyanotoxins. These are still under study but are not moving forward to Phase 2 because occurrence d ata are limited

.

• Clarify the term “ widely available analytic al method ” and what it mea ns in the context of this document

. [ EPA agreed to address these co mment s and further clarify the document

. ]
Charge Question 7: Does the P rotocol adequately explain the rationale for those contaminants that do not proceed through the process (i.e., through Phases 1 and 2)?

The expert reviewers generally considered the discussion in the P rotocol to be clear and logical with regard to the rationale f or Phase 1 determinations. However, there was considerable discussion regarding whether the document should address what happens next to these contaminants. The document should further discuss how the data gaps for contaminants deemed to have insufficient data in Phase 1 might be addressed, including:

• Will those contaminants not proceeding to Phase 2 be p laced into the Unregulated Contaminant Monitoring Regulation (UCMR) program?

• Will they be p laced back into the Contaminant Candidate List (CCL) if newer data becomes available?

• For a lay

- reader, what constitutes a data gap and “How big is a data gap before it causes an item to be dropped from moving forward in this process?”

• The group wanted more details on what conditions would trigger the re

- examinati on of a particular contaminant by EPA.

• What happens to “ no determination ” and “ negative determination ” contaminants?
[EPA explained that “no determination” conta minants that do not proceed to P hase 2 or 3 would be considered and prioritized for research to fill data gaps. For example, a contaminant that needs additional monitoring data could potentially be considered for inclu sion on a subsequent UCMR monitoring cycle (pending the availability of analytical methods) . EPA also expl ained that the CCL process involves an evaluation of c urrent c ontaminant health and occurrence data, a screening of contaminants and a selection of contaminants based on an evaluation of health and occurrence attributes. Contaminants that have a positive o r negative regulatory determination are not placed on a subsequent CCL unless new data indicate that the contaminant should be listed on CCL

. ]

Additional comments included:10 • The grouping of contaminants caused some confusion in the discussion.

o Why is one group in RD 3 process (nitrosamines) moving forward and another group ( c VOCs) not?

o What happens next if during a group evaluation a particular contaminant no longer
meet s the group criteria? Does it stay in this round of Regulatory Determination or doe s it go to the next round?
[EPA explained that the evaluation of the cVOCs (carcinogenic volatile organic compounds) as the first group for drinking water regulation was announced in February 2011 , while the RD 3 was in the midst of the Phase 2 evaluation

. The cVOCs, which include regulated and unregulated contaminants , is a separate but concurrent a gency effort

. Therefore, the contaminants included in th e cVOC group do not proceed to P hase 3 for this RD 3 evaluation . However, t he nitrosamines are being evaluated as part of this RD 3 and proceed to P hase 3 as a group. If particular contaminants no longer meet the group criteria, then they are removed from the group, but remain on the CCL and are considered for RD. The round of RD (e.g., RD 3, RD 4) that the contaminant will be considered for depends on the timing of the contaminant ’ s remov al from the group and its return to the CCL. The cutoff date for consideration for RD 3 is December 2011. However, the agency is able to make an off

- cycle determination, if warranted. ]
Charge Question 10: Are there additional information or factors that should be considered in any of the three phases? Please explain why. (Phase 1 only

. )

The discussion started with one expert reviewer suggesting that the prioritization of contaminants for RD 3 should happen in Phase 1 and not in Phase 2. Specifically, the question was raised that if Phase 1 has filtered out contaminants with supporting health assessment data but insufficient occurrence data, has EPA truly identified those contaminants posing the greatest health concern? Perhaps Phase 1 should seek to recommend contaminants with priority data collection needs to fill data gaps (e.g. prioritization to ORD for health assessments, data needs, and anal ytical method development).
Along those data gap lines, one expert reviewer questioned whether EPA is missing occurrences of contaminants, especially those with greater seasonality in occurrence that may not be found during a study timeframe. This reviewer noted that EPA may want to consider increased use of occurrence modeling to fill potential data gaps by modeling scenarios in which contaminants may be considered likely to occur.
[EPA agreed that although the process seeks to identify contaminants of gre atest public health concern, it is limited by the available data. As part of the RD process and other regulatory processes, data gaps are identified and referred to the research team. EPA agreed that there could be seasonal variability among some contamina nts. EPA also discussed the design of UCMR sampling and also some of the
current use s and/or potential applicability of modeling for the drinking water program .]
Additional discussion and comments suggested EPA should acknowledge its efforts to improve bot h the CCL and RD processes. Specifically, one expert reviewer suggested that in the RD 3 Protocol Appendix A ,11 the a gency may have missed an opportunity to acknowledge its support for and involvement in the FACA/Stakeholder process to validate and improve t he NRC recommended process for identifying CCL3 contaminants. Similarly, another expert reviewer suggested EPA needs to better e xplain the whole winnowing process to de s cribe how it got to the RDs (i.e., from universe to PCCL to CCL to shortlist to RD deci sions)

. Consider placing Appendix A in the main text of the document. Further, the agency should take more credit for the process it has established to identify potential drinking water contaminants given its resource constraints. The stakeholder process t hat EPA has established has led to real positive results and has gotten the best p rofessional expertise available

. This is best process given constraints.
[EPA agreed to further discuss the CCL3 process as it relates to the RD 3 process and move it from the P rotocol appendi ces to the main portion of the P rotocol document .]
Other comments discussed include the following:

• When discuss ing the minimum reporting limit ( MRL ), it would be beneficial to note the analytical metho d used to achieve a specific MRL (if it is known)

.

• The document s hould indicate that the potential source of contaminants was also a factor that was considered in selecting and evaluating contaminants

. S ome contaminants come from the treatment process itself ; pr oduced via coagulants, disinfection, etc.

• One expert r eviewer suggested using 1⁄2 HRL for the non

- national data to adjust for the uncertainty (instead of the HRL)

. [ EPA agreed to address these additional co mmen ts in the document

. ]



### 4.7 Regulatory Determination

– Phase 2 : Data Evaluation Overview of OGWDW’s Phase 2 Approach

– Zeno Bain, RD 3 Team Leader, 4.7.1 OGWDW
Zeno Bain discussed Phase 2 ( Data Evaluation ), explaining the purpose, the approach, the factors considered at each step, and outcome (see slides in Appe ndix A).
Expert Review Discussion of Phase 2 Charge Questions 4.7.2 Charge Question 5 : Are the information and factors considered in the Phase 2: Data Evaluation appropriate and sufficient for selecting contaminants of “greatest public health concern” to proceed to Phase 3: Regulatory Determination Assessment ?
This particular charge question generated significant discussion among the expert reviewers with regard to transparency in Phase 2 data evaluations. The expert reviewers noted that it appears that EPA has a method for prioritizing contaminants for this phase , but that the RD 3 Protocol document could be clearer in describing th e approach used to determine whether or not the contaminants posing the greatest public health concern were indeed identified in Phase 2. One expert reviewer stated that this is probably the one area of the report that could use greater clarity in describing the methodology. The RD12 3 Protocol Appendix E presents detailed information for each RD 3 contaminan t, but it is not clear how all the information in Appendix E is considered in order to select the contaminants that proceed to P hase 3. How did EPA aggregate all the factors into a decision? The expert reviewer suggested a decision tree would clarify how E PA prioritizes and reaches its decisions for this phase

. [EPA agreed that a decision tree would be useful

. ]
After much discussion among expert reviewers of the prioritization approach presented in the RD 3 Protocol , it was indicated that EPA is not actually developing a prioritization (i.e., ranking) of contaminants, but more of a binning approach to narrow down contaminants onto a list for further evaluation and regulatory consideration. There was broad agreement that this concept of binning needed to be made clearer in the document and prioritization may need to be removed from section titles since it gives the impression that direct contaminant comparisons were made resulting in individual rankings.
[EPA agreed that the process is not a prioritiza tion/ranking of contaminants but a binning among contaminants with no/low occurrence
, contaminants that have higher occurrence at health levels of

concern and contaminants that have insufficient data . EPA agreed to clarify this in the document

. ]

The expert reviewers indicated/noted that public perception of risk is an important consideration and EPA should define more clearly what is meant by the “greatest public health concern” so that the public can better understand the agency’s goals. A n expert re viewer observed that it is a challenge to make the method clear in the document such that the public will agree that the greatest health concerns are addressed and suggested EPA needed to develop an “elevator speech” for each contaminant in Phase 2 “... as to why it rose to the level of greatest public health concern.” The RD 3 Protocol Appendix F was identified as a place to put such a decision summary.
[EPA indicated that the terminology used for “greatest public health concern” is meant to describe thos e contaminants occurring in public water systems at a frequency and level of concern based on available data. EPA indicat ed that they do not have a “threshold or bright line” for separating those contaminants with no/low occurrence from those with moderate to high occurrence.]
Another area of discussion was the process for consideration of geographically or geologically

- limited occurrences and health risks. A n expert reviewer noted that a geographically localized problem could be considered a “greatest publ ic health concern” in some cases. Boron was cited as an example of a localized contaminant where a health advisory is issued. EPA should better explain the criteria it applies to geographic or geologically

- limited occurrences and risks

. [ EPA indicated that the agenc y do es not have a strict definition for localized, regional or national occurrence, b u t they do evaluate the number of systems and states in which a contaminant may be occurring at a level and frequency of concern. EPA also noted that in those ca ses in which they have found low levels of occurrence at health levels of concern (such as boron), the a gency does develop or updates health advisories to provide states/local agencies and water systems with health information

. ]13 A second expert reviewer agreed with the evaluation of geographically localized data and offered manganese as an example of a contaminant that ...”may have slipped through the cracks.” The reviewer further suggested that if there was a ranking for severity or potency ( suc h as a high/medium/low ) , the situation with manganese may have been avoided. EPA should make its criteria more transparent about how severity of the health effect is considered or factored into the process

.
Other ob servations and comments of the e xpert r eviewers included:

• The discussion of health effects (in the RD 3 Protocol Appendix E) could be made clearer for the reader using simple language.

• Concern was expressed that the HRL is the focus of the health risk determination. The underlying basis for th e HRL should be more clearly defined. Specifically, what is EPA assuming about what constitutes a public health concern (cancer vs. non

- cancer).

• What happens to contaminants that don’t proceed to Phase 3 (i.e., no determination contaminants) ?
[EPA indicate d that the severity of health effects was considered in the selection of contaminants for CCL3, but it is not a factor that is ranked or weighted in the Regulatory Determination process. All contaminants listed on CCL3 have been evaluated by the severity o f their adverse health effects and have been determined to have adverse health effects by the time they reach the RD phase . The RD process does not evaluate the severity of the health effects but rather the three SDWA criteria: ( 1) May the contaminant have an adverse effect on the health of persons? ( 2) Is it known to occur or is there substantial likelihood that the contaminant will occur at levels and frequencies of public health concern? ( 3) In the sole judgment of the Administrator, does regulation of the contaminant present a meaningful opportunity to protect public health ? ]
[ EPA acknowledged that this section of the P rotocol document could be made clearer and improve the document. EPA also note d that there is not a weighting or a ranking for the fac tors related to the health and occurrence information. ]
[ Note : At this point, the meeting adjourned for the day. The discussion of Phase 2 charge questi ons resumed on Thursday morning October 27, 2011.]
Charge Question 6 : Are the information and factors considered in the Phase 2: Data Evaluation appropriate and sufficient for selecting contamina nts that indicate “no to low potential for public health

concern ” to proceed to Phase 3: Regulatory Determination Assessment ?

The e xpert r eviewers indicated that the factors considered in Phase 2 are appropriate and sufficient for selecting contaminants that pose no or low potential for public health concern to proceed to Phase 3, with the caveat that the Question 5 comments are ade quately addressed by EPA. One expert reviewer concurred that the Phase 2 P rotocol is sufficient and appropriate ; however , the final Regulatory Determination could reverse this opinion if they are not consistent.14 Public perception of agency actions with re gard to negative determinations was also discussed , and one expert reviewer suggested the agency has taken unfair criticism from the public because of all the negative determinations in the past , but “we have determined there are not a lot of problems in t he water supply. We have identified contaminants but determined that they are not posing problem which suggests intent of SDWA working.” Expert r eviewers indicated that negative determinations are just as important as positive one s in alleviating public co ncern about contaminants that may/may not occur in their water. Other expert reviewers agreed and indicated that the a gency should take credit for implementing a rigorous process to identify and evaluate contaminants , and that knowledgeable people see the negative determinations as a positive result when the public may possibly see these as a negative result. Additionally, providing more explanation to the general public about past negative determinations could be useful.
[ EPA noted that in identifying and selecting contaminants that may be negative determinations, the

a gency attempts to select candidates that have the best available information since the decision to “ not regulate ” a contaminant is judicially reviewable. The a gency agreed that negative determinations were just as important as positive determinations since it may help alleviate public concern about a particular contaminant. ]
Additional comments and suggestions for improving the Phase 2 determinations discussio n included the following:

• With regard to the 11 contaminants identified in the P rotocol document, identify which of these came through the bulleted list of criteria in the P rotocol (i.e., which category or bin did they fall under).

• Provide greater clari ty about how or what happens to contaminants designated no/low that may be become negative determinations, especially if new information becomes available (e.g. manganese)

.

• State that a negative determination is important and for what reasons.

• Occurrence data findings are summarized for particular contaminant s in Appendix E of the P rotocol . Provide the same type of summary for the health findings.
[EPA agreed to include language about the importance of negative determinations, as well as provide an expla nation of what happens to negative determinations and how new information might be considered. Additionally, EPA agreed to provide a health summary in Appendix E similar to the occurrence summary

. ]
Charge Question 7: Does the P rotocol adequately explain the rationale for those contaminants that do not proceed through the process (i.e., through Phases 1 and 2)?
The discussion began with a n expert reviewer comment that the document again needs to be clearer as to what happens to those co ntaminants that do not make it through the process. This was followed with

a n other expert reviewer comment that EPA should further clarify that a negative determination contaminant goes “back to square one”, but if any new information becomes available it may return15 quickly to its place on the list ahead of others and “is right back on the table” for consideration. Therefore, the negative determination is not as final as it appears.
It was suggested that a CCL sublist or “parking lot” of previous negativ e determination contaminants be developed so that when new information becomes available , it more easily can be brought back for CCL consideration. The expert reviewers seemed to like the parking lot concept.
[Note: An EPA staff person pointed out that thi s type of process would not have picked up manganese.]

One expert reviewer suggested that EPA include a summary under the health and occurrence information to furthe r explain what the data gap is (i.e., what is the occurrence data gap or specific health da ta gap)? Are these data gaps treated equally? Provide more details on why some chemicals make it through the process and other s do not when it appears that the data evaluation identifies equivocal concerns. Alachlor was cited as an example.

Another expert reviewer cited the example of dimethoate ( which proceeds) and disulfoton ( which does not proceed), presumably on the basis of national data availability. Clarify the a gency’s thought process since disulfoton has no national data so you cannot answer yes to the P rotocol question, “Does the contaminant have national finished water data showing no or low number or percentage of detections ≥ draft HRL?”. This part of the P rotocol should be clearer because it is part of a decision tree and could be presented as such. Furthermore, why move a contaminant forward from Phase 1 to 2 with non

- national data only, but then not allow it to proceed from Phase 2 to 3 with non

- national data?
[ EPA agreed to better explain why some chem icals proceed and others do not ( e.g., dimethoate and disulfoton) and the nature of any data gap(s) or exception s for contaminants that do not proceed

. EPA also agreed to provide an explanation of what happens to negative determinations and how new informa tion might be considered

. Charge Question 10: Are there additional information or factors that should be considered in any of the three phases? Please explain why. (Phase 2 only.)

The expert reviewers offered few comments in response to this charge questio n as they felt they had made the relevant points already for other questions, especially those pertaining to contaminant prioritization. Issues and concerns that were discussed included:

• Need better information/discussion about how the HRL is developed wit h consideration to sensitive sub

- populations.

• The document could better explain the concept of contaminant grouping and how determinations for contaminants within groups are made. For example, a positive determination for one or more contaminants within a group can move a group forward even if

an individual contaminant (s) within the group is not of public health concern. In addition, further explain how a potential negative determination for an individual contaminant do es not allow the group to proceed forward if other contaminant s in the group have data gaps (i.e., no determination).16 • The expert reviewers discussed several issues related to analytical methods. Analytical method s need to be spelled out more clearly. Mini mum Reporting Levels are an important determinant and need to be better discussed in the P rotocol ( possibly earlier in document). (Also, one expert reviewer noted that we need to distinguish MRLs for analytical methods from MRLs used in health assessments like those made by ATSDR)

.

• How EPA defines a method is important, especially to states for establishing lab capacity. This is an important point f or the regulated community. Cost considerations for acquiring lab services are significant at public utilities , so establishing analytical methods with little capacity in the market, drives prices way up for utilities.

• EPA needs to think about what happens if the demand for a method drops significantly. Labs will not be able to perform the necessary analyses at ve ry low volumes.

• How much capacity must be available for a method to be considered “widely available”?
[EPA agreed to clarify a few of these items where possible, which included: how sensitive populations are considered, the evaluation of contaminant group s, analytical methods/MRLs used for monitoring and potential uncertainties/limitations
, and explaining the distinction between MRL terminologies for analytical methods and health. Some of the other analytical methods comments may be more relevant to other regulatory efforts.]



### 4.8 Regulatory Determination

– Phase 3 : Regulatory Determination Assessment Overview of OGWDW’s Phase 3 Approach

– Zeno Bain, RD 3 Team Leader, 4.8.1 OGWDW Zeno Bain explained the approach used for Phase 3 along with the factors considered at each step and the outcome (see slides in the Annex to this meeting summary ).
Expert Review Discussion of Phase 3 Charge Questions 4.8.2 Charge Question 8 : In Phase 3: Regulatory Determination Assessment , has the a gency used the best available science and integrated the data appropriately to evaluate the first and second statutory criteria for each of the contaminants selected for Regulatory Determination 3?

The expert r eviewers generally agreed that th e a gency had identified the best available science and integrated the information appropriately but could provide more transparency in the Regulatory Determination decision making. They noted that the RD 3 P rotocol list numerous factors that are considered in making a regulatory determination

. While t h e bulleted list of factors suggests a sequence of steps or a decision process , the expert reviewers wanted to know whether and how these factors are weighted

. Is any one fac tor more important than another? Are a majority of factors needed or only one? What factor, if any, would tip the scale on a decision?17 The expert reviewers would like for the agency to define or clarify what it considers to be best available science, whi ch appears to differ at times within the agency . What criteria were applied to choose a dataset? What is sufficient or necessary to make a decision?
As it applies to the development of the HRL, another expert reviewer agreed , stating that if using the best available science, then are we using the most recent studies, since it did not come through in the report that the science literature on health effects to create the final HRL has been updated as the regulatory determination is closer to being made. It is not clear that some of the health data assessment may be dynamic throughout the determination process and appears that it can be based on static or older studies. Make it clear er that the HRL is not finalized until you have completed the health support do cuments

.
Additional comments included:

• The agency has diligently considered the science; however, when the preliminary regulatory determination is published, it is important to note that the public has opportunity to bring additional information to EPA’s attention

.

• In the P rotocol , there was some confusion over the d efinition and use of HRLs as benchmarks. Are we comparing to one benchmark carcinogen? Need to b etter explain the use of the b enchmark term in the context of the HRL

.

• Use and trends could be important to consider for evaluating “likely to occur

. ”
[EPA agreed to address these additional co mment s in the document.]
Charge Question 9 : In the evaluation of the first and second statutory criteria for Regulatory Determination 3, did the agency approp riately consider the available health effects on sensitive populations?
The discussion began with one expert reviewer noting that they were encouraged to see that EPA has considered available health effects on sensitive sub

- populations , particularly infants and pregnant

wom e n , as part of this RD 3 Protocol

. Still , the document should be clearer with regard to how the data for these subgroups was evaluated. The RD 3 Protocol document qualitatively discusses the exposure risks to these sub

- populations in Appendix E. Quantifying risk for sensitive sub

- population, however, is difficult and extremely important and is included in EPA’s analysis , but it may not be apparent to a reader. The reviewer further indicated surprise at how important dri nking water intake rates were for infants and pregnant wom e n in the studies they examined and was encouraged to know that EPA accounts for differential drinking water intake rates for sensitive sub

- populations in its analysis of health risk. This informati on should be made more obvious in the calculation of the HRL and included in Appendix E.
[EPA noted that strontium is an example of where age

- specific drinking water intake rates are being applied to better characterize exposure during the period of sensit ivity (i.e. , bone growth). In addition,
age

- dependent adjustment factors (ADAFs) are being considered in calculating the HRL for the nitrosamines since they are mutagenic carcinogens. The information regarding sensitive sub

- populations18 and HRLs will be cla rified within the RD 3 Protocol and will be further explained in the RD 3 Health Effect Support Documents.]
Charge Question 10: Are there additional information or factors that should be considered in any of the three phases? Please explain why. (Phase 3 o nly.)

The e xpert reviewers had little to add in response to this question that they had not already commented on earlier. The points that were raised during this discussion included:

• One commenter asked if there a staff document that feeds into the Administrator’s Decision.
[EPA noted that they brief senior managers on the information and recommendations .]



### 4.9 Regulatory Determination

– Overall Charge Questions Comments Expert Review Discussion of Overall Char ge Questions 4.9.1 Charge Question 1 : Is the approach and evaluation described in the Regulatory Determination 3 Protocol clear, consistent and transparent?
The expert r eviewers concurred, with a few individual caveats , that the overall approach and evaluation d escribed in the RD 3 Protocol was clear, consistent, and transparent. A Reviewer did add that more explanation is needed in those sections of the P rotocol where judgment is applied to ensure consistency , and that transparency should carry through the entire document. Any references to appendix material should carry the same level of transparency supported by additional notations (e.g., datasets).
Charge Question 2 : Does the Regulatory Determination 3 Pro tocol sufficiently explain EPA’s interpretation and evaluation of the first and second SDWA statutory criteria used for making a regulatory determination , particularly criteria one and two ? Note: The third statutory criterion is in the sole judgment of the Administrator.
The expert r eviewers concurred, with the same caveats and comments noted in the discussion of the previous question s , that the overall approach and evaluation described in the RD 3 Protocol sufficiently explained EPA’s interpretation and ev aluation of the first and second SDWA statutory criteria for making regulatory determinations. Additional comments included:

• Further clarify the discussion of Low/No public health concern determination. Provide better understanding of which criteria tip the scale (i.e., decision tree).
Charge Question 3 : Does the overall Regulatory Determination 3 process described in the P rotocol identify and focus on contaminants of greatest public health concern to be referred to the Administrator for an evaluation of the third statutory criterion (i.e., to determine whether or not regulation presents a meaningful opportunity for health risk reduction for persons served by public water systems)?19 The expert r eviewers concurred, with the same caveats and comments noted in previous discussions, that the overall RD 3 process described in the P rotocol (using the available knowledge and data) identified and focused on contaminants of greatest public health concern to be referred to the Administrator for an evaluation of the third statutory criterion. Additional comments included:

• Data limitations may stop a contaminant from moving forward even though it is believed to be of significant health concern. Cyanotoxins are a good example of this limitation.

• Be clear that the P rotocol , as presented , is not an exercise in prioritization but is an exercise in binning or narrowing down after the highly st ructured prioritization scheme used in CCL3.

• Provide more discussion as to why nitrosamines move forward and C VOCs do not. Why does nitrobenzene fall out? 1,2,3 trichloropropane is not considered as a C VOC by some stakeholders/experts

.

• If specific conta minants in a group fall out of that group , how are they recaptured in the RD process? A b ack

- up plan is needed for these contaminants

.

• Need to explain to the lay person why hot topic issues/contaminants in the news may not be on the list and why , as well a s further clarify the agency’s definition of “greatest public health concern”.
[EPA agreed to clarify the following items

– (a) binning versus prioritization for RD 3 and that RD 3 follows a highly structured CCL prioritization process, (b) better explain why some groups move forward and others do not, (c) explain what happens if a contaminant falls out of a group , and (d) explain the use of the term “greatest public health concern” in the context of a regulatory determination

. ]



### 4.10 Key Summary Comments from the Expert Reviewers The final segment of the RD 3 Expert Review Meeting involved a quick summary of the reviewer ’ s main comments on the RD 3 P rotocol document. These key comments are as follows:

1. Explain better the criteria for selecting the health and occ urrence data sources used in the RD 3 Protocol. Explain how EPA identifies and evaluates these data sources. What qualified as best available data and which were more informative and used for corroboration ? What is definition of best available science?

2. Exp lain what happens to the “no determination contaminants

. ” How are data gaps filled for those with no determinations?

3. What happens to the potentially negative determinations? How can they be reconsidered?

– The Parking Lot concept. Explain why there may be more negative contaminants than positive determinations. Also explain the benefits of a negative determination and how it provides evidence that SDWA is working.20 4. Explain how contaminants are identified by binning using different criteria (e.g., data avai lability and occurrence above the threshold of public health concern )

. Prioritization language may need to be removed from document.

5. Explain where “judgment” is used. Specifically , Phase 2 would benefit from a decision tree.

6. Further define “greatest/thr eshold of public health” subject to availability of data and ability to proceed with regulation.

7. Explain what happens to contaminants in a group (e

. g. , n itrosamines or CVOCs). Why are they being treated in a different process? What happens to those specifi c contaminants that fall out of the group? Where and when do they enter back into the process?

8. More on CCL 3 background and process discussion ( move to body of document ). Further explain the ranking/prioritization scheme used and the conclusions from those rankings in RD 3 (i.e., all have adverse health effects). T ake more credit and demonstrate stakeholder outreach to show effort. List the stakeholders that were involved in the process.

9. Definition and use of HRLs as benchmarks is not entirely accurate ; HRL s are normalized. Health risk level is not equivalent in a numeric sense in that each endpoint is not the same.

10. Better explain how sensitive sub

- populations are considered in the process , both qualitatively and quantitatively , as it applies to derivation of the HRLs . It is included in the derivation but it is not described well. What are statutory drivers to consider risks to sensitive sub

- populations ?
The individual expert reviewer’s written comments and agency responses can b e found in Response to External Expert Review of the Regulatory Determination 3 Protocol.

## Annex

Expert Review Meeting Slideshow

October 26

- 27, 2011

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1 

# Regulatory Determinations 3

Expert Review Meeting Washington D.C.

October 26-27, 2011

USEPA Office of Ground Water and Drinking Water



# Background on Regulatory Determinations

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## SDWA Regulatory Processes

Contaminant Candidate List (CCL) – List of unregulated contaminants that are known or may occur in drinking water; publish every 5 years.

Regulatory Determinations – Decisions on whether to regulate CCL contaminants with a drinking water standard; make decisions on a t least 5 every 5 years; Must consider 3 SDWA criteria. If decide to regulate, SD WA requires EPA to propose in 24 months and finalize in 18 months.
Unregulated Contaminant Monitoring – Process to monitor at least 30 different unregulated contaminants every 5 years.
Regulation Development - If regulate, SDWA requires that we evaluate/consid er a number of factors in the standard setting process ( health, analytical/treatment feasibility, costs/benefits, etc).

Six Year Review – Every 6 years, review and (if appropriate) revise the standard. Any revision must maintain or improve public health pro tection. If revise, we go through the regulation development process again and evaluate a number of factors.

3



## General Flow of SDWA Regulatory Processes

*For these three stages, we like to have increased specificit y and confidence in the type of supporting data used (e.g. health and occurrence). SDWA requires that w e used best available data to make our decisions. List unregulated contaminants* “Contaminant Candidate List ”

Review & decide whether to revise the standard

“ Six Year Review ” Determine whether at least five need a drinking water standard*

“ Regulatory Determinations ” Develop or revise the drinking water standard*

“ Regulation Development ” List and collect monitoring data at least 30 unregulated contaminants

“ Unregulated Contaminant Monitoring ” If yes

If yes

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## Three Regulatory Determination Criteria SDWA requires EPA to consider the following criteria in evaluating whether to regulate a contaminant:

2) The contaminant is known to occur or there is substantial likelihood that the contaminant will occur in public water systems with a frequency and at levels of public health concern; and 1) The contaminant may have an adverse effect on th e health of persons;

3) In the sole judgment of the Administrator, regul ation of such contaminant presents a meaningful opportunity for he alth risk reduction for persons served by public water system s.
*SDWA Section 1412(b)(1)

5



## Potential Outcome of Determinations

• No Regulatory Determination – Insufficient data to assess contaminant on three c riteria



### • Positive Determination – Answer “yes” decision for “all three” criteria – Begin process to develop a drinking water regulati on



### • Negative Determination – Answer “no” for “any one” of the three criteria – Do not develop a drinking water regulation – Developing a Health Advisory is a non-regulatory o ption # Outcome 1  2 x 3 x

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## CCL & Regulatory Determinations Timeline

**Regulatory Determination 1**  2008

**Regulatory Determination 2** 

2009 **CCL3: 116 Contaminants**  **See Appendix A**

2013

**Regulatory Determination 3**  2005 **CCL2: 51 Contaminants** 

1998 **CCL1: 60 Contaminants** 

**9 Negative Determinations**

**0 Positive Determinations 11 Negative Determinations**  **0 Positive Determinations Perchlorate –**  **Published positive determination 2/11** 

7



# Background on Drinking Water Strategy

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## Drinking Water Strategy March 2010 Administrator Announcement
1. Address contaminants as groups rather than one at a time. 2. Foster development of new drinking water treatment technologies. 3. Use the authority of multiple statutes to help prote ct drinking water. 4. Partner with states to share more complete data from monitoring at public water systems.

9



## What Did We Hear From Outreach Efforts?

• Public health protection should be of paramount im portance.
• Consider the following: – Health effect endpoints in grouping of contaminant s – Treatment feasibility to identify/address contamin ant groups – Analytical methods and/or use surrogates – Occurrence and co-occurrence of contaminants – Addressing groups of contaminants at their source • Evaluate approaches used by States and other count ries.
• Consider non-regulatory approaches (e.g. health advisories).

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## Potential Factors & Preliminary Evaluation

• Sept 2010 DWS Stakeholder Meeting - Identified four factors to consider when evaluating groups: – Has similar health effect endpoint – Removed by common treatment or control processes – Measured by common analytical method(s) – [Known or likely occurrence and co-occurrence] • “Promising” groups likely to have multiple factors in common. • Sept 2010 DWS Stakeholder Meeting – EPA indicated t hat we would evaluate nitrosamines as a group; addressing as par t of RD3. • February 2011 – announced that EPA would evaluate c arcinogenic Volatile Organic Compounds (cVOCs) as the first gro up for regulatory effort (several listed on CCL3 and mentioned in tod ay’s discussion).

11



# Overview of Regulatory Determinations 3

Protocol

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# RegDet 3 Process Flow (Page 12)

13 **Health Data Availability Assessment** 

• Health Assessment available or in process **Occurrence Data Availability Assessment** 

• National data “or”

• Non-national data with detects greater than CCL3 derived HRL

**Evaluation of Outcomes of Health & Occurrence Data Availability Assessments**  Does it potentially have sufficient health and occurrence data available? **Phase 1: Data Availability & Evaluation**

**Phase 2: Data Evaluation & Prioritization Phase 3:**  **Regulatory Determination Assessments**

**Step 1:** Collect & Evaluate Health Information and Derive a Draft HRL

**Step 2:** Gather & Evaluate Additional Occurrence Data Sources Relative to the Draft HRL **Evaluate Statutory Criteria 2: Occurrence Assessment**  Does the contaminant occur above the HRL at a frequency and level of public

health concern? **Evaluate Statutory Criteria 1: Health Assessment**  May the contaminant have an adverse effect on the health of

persons?

**Evaluate Statutory Criteria 3: Meaningful Opportunity Assessment**  **(Administrator’s Decision)** In the sole judgment of the Administrator, does regulation of such contaminant present a meaningful opportunity for health risk reduction for persons served by

public water systems? **CCL3**

**Step 4:** Identify Contaminants That Have No or Low Potential for Public Health Concern **Step 3:** Identify Contaminants of Greatest Public Health Concern



## Phase 1: Data Availability and Evaluation (Page 12) Criteria to proceed to phase 2: • A health assessment available or in process, and • Widely available analytical method for monitoring available, and • National finished water monitoring data available, or • Non-national finished water monitoring data with 1 or more detections ≥ CCL3 HRL • Note: Contaminants can proceed as part of a group based on factors defined by the Drinking Water Strategy • Disulfoton and Diuron were exceptions to the criteria. The combination of UCMR1 Screening Survey and supplementary data allowed these contaminants to proceed without “national” data. Health Data Availability Assessment

• Health Assessment available or in process Occurrence Data Availability Assessment

• National data “or”

• Non-national data with detects greater than CCL3 derived HRL

Evaluation of Outcomes of Health & Occurrence Data Availability Assessments Does it potentially have sufficient health and occurrence data available? **Phase 1: Data Availability & Evaluation**

**116 CCL3**

34 Contaminants proceed to Phase 2

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## Health Data and Information Sources (Page 13) • Identify recent or in process Agency risk assessme nts from: – The Agency's Integrated Risk Information System (I RIS), – The Agency’s Office of Water (OW), – The Agency's Office of Pesticide Programs (OPP), – The National Academy of Sciences (NAS), and/or – The Agency for Toxic Substances and Disease Regist ry (ATSDR)
• Identify the following: – Potential health effects – Reference Dose (RfD) or other non-cancer health va lue, and/or – Cancer slope factor
• For phase 1, HRLs from 2009 CCL3 were used to eval uate nonnational drinking water data.

15



## National Finished Water Occurrence Data Sources (Page 13)

• Unregulated Contaminant Monitoring Regulation (UCMR )

– UCMR 1 Assessment (2001 – 2003)

– UCMR 2 Assessment (2008 – 2010)

• Unregulated Contaminant Monitoring (UCM)

– Round 1 (1988 – 1992)

– Round 2 (1993 – 1997)

• National Inorganics and Radionuclides Survey (NIRS) (1984 – 1986)

• Occurrence results presented as the number/percent of systems with an analytical result > a specified concentration (e .g., > MRL (detection), > 1⁄2 HRL or HRL, etc.).

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## Non-National Finished Water Occurrence

Data Sources (Page 14) • UCMR1 (SS) • State Data • DBP-ICR • Supplemental DW data (e.g., PDP, PMP, NREC, target surveys, localized state/federal monitoring studies

• For phase 1, HRLs from 2009 CCL3 were used to eval uate nonnational drinking water data (1 or more detections ≥ CCL3 HRL to proceed)

17



# See Appendix D in the RD3 Protocol: Summary of Phase 1 Data Availability and Evaluation

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## Phase 1 Charge Questions

• Question 4: Are the data availability criteria used in Phase 1: Data Availability and Evaluation appropriate for identifying contaminants with sufficient health and occurrence data/information to be placed on the “short list” t o proceed to Phase 2: Data Evaluation and Prioritization ?

• Question 7: Does the protocol adequately explain the rationale for those contaminants that do not proceed through the process (i.e., through Phases1 and 2)?

• Question 10: Are there additional information or factors that should be considered in any of the three phases? Pl ease explain why. (Any comments that apply to Phase 1)

19



# Discussion of Phase 1 Comments
October 26 - 1:55 pm to 2:55 pm

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### 5/1/2014

11 **Phase 2: Data Evaluation & Prioritization**
Step 1 Collect & Evaluate Health Information and Derive a Draft HRL

Step 2 Gather & Evaluate Additional Occurrence Data Sources Relative to the Draft HRL Step 4 Identify Contaminants that have No or Low Potential Public Health Concern Step 3 Identify Contaminants of Greatest Public Health Concern 

## Phase 2: Evaluation and Prioritization (Page 16)

11 Contaminants proceed to Phase 3 Criteria to proceed to phase 3: • Identified as a contaminant of greatest public health concern

OR • Identified as a contaminant of no or low public health concern with sufficient data to evaluate the statutory criteria

21



## Contaminants of Greatest Public Health Concern (Page 17)
• How many samples (# and %) have detections ≥ draft HRL in the national and non-national finished water occurrence data?

• How many systems (# and %) have detections ≥ draft HRL in the national and non-national finished water occurrence data?

• Is the contaminant associated with a contaminant g roup that is of public health concern and is being considered as pa rt of the Drinking Water Strategy?

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## Contaminants that have No or Low Potential for Public Health Concern (Page 18)

• Does the contaminant have national finished water data showing no or low # or % of detections ≥ draft HRL? • If a contaminant has non-national finished water d ata, does it support no or low potential for occurrence in drinking water? • Does additional occurrence information support low or no occurrence or potential for occurrence in drinking water? For example, is t he occurrence in ambient/source water at levels below the draft HRL? Are releases to the environment or use/production decreasing over time? • Is there a health assessment for the contaminant t hat requires no or minimal updates and will any updates be completed by Fall 2 011? • There are no critical information/data gaps or unc ertainties after evaluating the available health or occurrence data. • The contaminant is not included or being evaluated with a group of contaminants being considered as part of the Drinking Water Stra tegy (e.g. cVOCs).

23



# See Appendix E in the RD3 Protocol: Summary of Phase 2 Data Evaluation and Prioritization

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13 

## Phase 2 Charge Questions

• Question 5: Are the information and factors considered in the P hase 2: Data Evaluation and Prioritization appropriate and sufficient for selecting contaminants of “greatest public health c oncern” to proceed to Phase 3: Regulatory Determinations Assessment ?

• Question 6: Are the information and factors considered in the P hase 2: Data Evaluation and Prioritization appropriate and sufficient for selecting contaminants that indicate “no to low pot ential for public health concern” to proceed to Phase 3: Regulatory Determinations Assessment

?

• Question 7: Does the protocol adequately explain the rationale for those contaminants that do not proceed through the process (i.e., through Phases 1 and 2)?

• Question 10: Are there additional information or factors that sh ould be considered in any of the three phases? Please expla in why. (Any comments that apply to Phase 2)

25

26 

# Discussion of Phase 2 Comments
October 26 – 3:25 pm to 4:45 pm October 27 – 9:15 am to 9:55 am

### 5/1/2014

14 **Phase 3: Regulatory Determination Assessments** 

Evaluate Statutory Criteria 2: Occurrence Assessment Does the contaminant occur above the HRL at a frequency and level of public health concern? Evaluate Statutory Criteria 1: Health Assessment May the contaminant have an adverse effect on the health of

persons?

Evaluate Statutory Criteria 3: Meaningful Opportunity Assessment (Administrator’s Decision) In the sole judgment of the Administrator, does regulation of such contaminant present a meaningful opportunity for health risk reduction for persons served by public water

systems? • Chlorate • Dimethoate • 1,3- Dinitrobenzene • N-nitrosodimethylamine (NDMA) • N-nitroso-di-n-propylamine (NDPA) • N-nitrosodiethylamine (NDEA) • N-nitrosopyrrolidine (NPYR) • RDX • Strontium • Terbufos • Terbufos Sulfone

27 

## Phase 3: Regulatory Determination Assessments (Page 20)



## Evaluation of Statutory Criteria #1 (Page 20)


### • Complete health assessment that needed to be updated and peer-reviewed, if necessary • Identify adverse health effect(s) • Derive final peer-reviewed HRL

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15 

## Factors of Primary Consideration for Evaluation of Statutory Criteria #2 (Page 21)
• How many samples (# and %) have detections ≥ final HRL in the national and non-national finished water occurrence data? • How many systems (# and %) have detections ≥ final HRL in the national and non-national finished water occurrence data? • Is the contaminant associated with a contaminant g roup that is of public health concern and is being considered as part of the DWS? • Is the geographic distribution of contaminant occu rrence national, regional or localized? • In addition to the number of systems, what type of systems does the contaminant occur in? Does the contaminant occur in large or small systems? Does the contaminant occur in surface or ground wat er systems? • Are there significant uncertainties or limitations with the data and/or analyses, such as the age of the dataset, limitation of the d etection limit (i.e. MRL > final HRL) and/or representativeness of the data (e.g. li mited in scope to a specific region)?

29



## Additional Factors of Consideration for Evaluation of Statutory Criteria #2 (Page 21) • How many samples (# and %) have detections ≥ 1⁄2 final HRL in the national and non-national finished water occurrence data? • How many systems (# and %) have detections ≥ 1⁄2 final HRL in the national and non-national finished water occurrence data? • How many samples (# and %) have detections ≥ final HRL and 1⁄2 final HRL in the ambient/source water occurrence data? • How many sites (# and %) have detections ≥ final HRL and 1⁄2 final HRL in the ambient/source water occurrence data? • Are production and use trends for the contaminant increasing or decreasing? • How many pounds are discharged annually to surface water and/or released to the environment? • Do the environmental fate and transport parameters indicate that the contaminant would persist and/or be mobile in water ? • Are there other uncertainties or limitations with the data and/or analyses for these additional factors that should be conside red?

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16 

# See Appendix F in the RD3 Protocol: Summary of Phase 3 Regulatory Determination 3 Assessments

31



## Phase 3 Charge Questions

• Question 8: In Phase 3: Regulatory Determinations Assessment
, has the Agency used the best available science and integrated the data appropriately to evaluate the first and second statutory criteria for each of the contaminants selected for Regulator y Determinations 3?

• Question 9: In the evaluation of the first and second statutory criteria for Regulatory Determinations 3, did the A gency appropriately consider the available health effects on sensitive populations?

• Question 10: Are there additional information or factors that should be considered in any of the three phases? Pl ease explain why. (Any comments that apply to Phase 3)

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17 33 

# Discussion of Phase 3 Comments October 27 – 10:30 am to 11:30 pm

Additional Overall Charge Questions

• Question 1: Is the approach and evaluation described in the Regulatory Determinations 3 Protocol clear, consist ent and transparent?

• Question 3: Does the overall Regulatory Determinations 3 described in the protocol identify and focus on con taminants of greatest public health concern to be referred to th e Administrator for an evaluation of the third statutory criterion (i.e., to determine whether or not regulation presents a meaningful opp ortunity for health risk reduction for persons served by public water systems?

• Question 2: Does the Agency’s Regulatory Determinations 3 Protocol sufficiently explain EPA’s interpretation and evaluation of the first and second SDWA statutory criteria used f or making regulatory determinations? Note: The third statutor y criteria is in the sole judgment of the Administrator.

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18 35 

# Discussion of Overall Comments October 27 – 11:30 am to 12:30 pm



# Appendices

Appendix A – Contaminant Candidate List 3 Appendix B – Outreach for Addressing Contaminants as Groups

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## Appendix A: Unregulated CCL 3 Contaminants 106 Chemicals and 12 Microbes

1,1,1,2-Tetrachloroethane 1,1-Dichloroethane 1,2,3-Trichloropropane 1,3-Butadiene 1,3-Dinitrobenzene 1,4-Dioxane 17 alpha-Estradiol 1-Butanol 2-Methoxyethanol 2-Propen-1-ol 3-Hydroxycarbofuran (degradate) 4,4'-Methylenedianiline Acephate Acetaldehyde Acetamide Acetochlor Acetochlor ethanesulfonic acid (ESA) Acetochlor oxanilic acid (OA) Acrolein Alachlor ethanesulfonic acid (ESA) Alachlor oxanilic acid (OA) alpha-Hexachlorocyclohexane (former) Aniline Bensulide Benzyl chloride Butylated hydroxyanisole Captan Chlorate (also D-DBP) Chloromethane (Methyl chloride) Clethodim Cobalt Cumene hydroperoxide Cyanotoxins (3) Dicrotophos Dimethipin Dimethoate Disulfoton Diuron Equilenin Equilin Erythromycin Estradiol (17-beta) Estriol Estrone Ethinyl Estradiol (17-alpha) Ethoprop Ethylene glycol Ethylene oxide Ethylene thiourea Fenamiphos Formaldehyde (formerly) Germanium Halon 1011 (Bromochloromethane) HCFC-22 Hexane Hydrazine Mestranol Methamidophos Methyl bromide (Bromomethane) Methyl tert-butyl ether Metolachlor Metolachlor ethanesulfonic acid (ESA) Metolachlor oxanilic acid (OA) Molinate Molybdenum Nitrobenzene Nitroglycerin N-Methyl-2-pyrrolidone N-Nitrosodiethylamine (NDEA) N-nitrosodimethylamine (NDMA) N-Nitroso-di-n-propylamine (NDPA) N-Nitrosodiphenylamine N-nitrosopyrrolidine (NPYR) Norethindrone (19-Norethisterone) n-Propylbenzene o-ToluidineOxirane, methylOxydemeton-methyl Oxyfluorfen Perchlorate Perfluorooctane sulfonic acid (PFOS) Perfluorooctanoic acid (PFOA) Permethrin Profenofos Quinoline RDX sec-Butylbenzene Strontium Tebuconazole Tebufenozide Tellurium Terbufos Terbufos sulfone Thiodicarb Thiophanate-methyl Toluene diisocyanate Tribufos Triethylamine Triphenyltin hydroxide (TPTH) Urethane Vanadium Vinclozolin Ziram

Adenovirus Caliciviruses Campylobacter jejuni Enterovirus Escherichia coli (0157) Helicobacter pylori Hepatitis A virus Legionella pneumophila Mycobacterium avium Naegleria fowleri Salmonella enterica Shigella sonnei

37



## Appendix B: Outreach for Addressing Contaminants as Groups

• Informal Planning Meeting (June 7) • 4 Listening Sessions  June 21 – Chicago, IL  Aug 11 – Cincinnati, OH  Aug 16 – Washington, DC  Aug 19 – Rancho Cucamonga, CA • National Drinking Water Advisory Council Consultat ion (July 21) • Web Dialogue (July 28-29) and Web Forum (July 2010 to Jan 2011) • Stakeholder Meeting (Sept 21) • ASDWA Annual Meeting (Oct 18-21) • National Drinking Water Advisory Council Consultat ion (Dec 8 & 9)

38