*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 1 of 108 EO12866_UCMR3 Part 141 and 142_2040 AF10_draft FRN_20111028.docx ENVIRONMENTAL PROTECTION AGENCY

40 CFR Parts 141 and 142

[Docket No. EPA
- HQ
- OW -2009- 0090; FRL - ]

RIN 2040- AF10

Revisions to the Unregulated Contaminant Monitoring Regulation ( UCMR 3 ) for Public Water Systems

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final Rule.

_______________________________________________________________________ SUMMARY: The 1996 amendments to the Safe Drinking Water Act (SDWA) require that the United States Environmental Protection Agency (EPA or the Agency ) establish criteria for a
program to monitor unregulated contaminants and publish a list of contaminants to be monitored every five years. This final rule meets the SDWA requirement by p ublishing the third Unregulated Contaminant Monitoring Regulation (i.e., UCMR 3), listing the unregulated contaminants to be monitored and addressing the requirements for such monitoring. This final*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 2 of 108 rule describes analytical methods to monitor for 28 UCMR 3 chemical contaminants and describes the monitoring for two viruses, for a total of 30 UCMR 3 contaminants. EPA is also requiring the monitoring of total chromium under the authority provided in the SDWA. UCMR 3 provides EPA and other interested parties wi th scientifically valid data on the occurrence of these contaminants in drinking water, permitting the assessment of the number of people potentially being exposed and the levels of that exposure. These data are one of the primary source s of occurrence and exposure information the Agency uses to develop regulatory decisions for these contaminants. In addition, as part of an Expedited Methods Update, this rule finalizes amendatory language for the table in the Code of Federal Regulations (CFR). This minor editorial correction to the table moves methods from the “Other” column to the “ASTM” column, as it applies to the inorganic chemical sampling and analytical requirements. The UCMR program is not affected by these changes.

DATES: This final rule is effect ive on [INSERT DATE 30 DAYS AFTER DATE OF PUBLICATION IN THE FEDERAL REGISTER] . For purposes of judicial review, this rule is promulgated as of 1 p.m. eastern time on [INSERT DATE OF PUBLICATION IN THE FEDERAL REGISTER ] as provided in 40 CFR 23.7. The inco rporation by reference of certain publications listed in this rule is approved by the Director of the Federal Register as of [INSERT DATE 30 DAYS AFTER DATE OF PUBLICATION IN THE FEDERAL REGISTER]

.

ADDRESSES: EPA has established a docket for this action under Docket ID No. EPA- HQ

- OW

2009-0090. All documents in the docket are listed in the index at www.regulations.gov

.*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 3 of 108 Although listed in the index, some information is not publicly available, e.g., confidential busin ess information (CBI) or other information , the disclosure of which is restricted by statute. Certain other material, such as copyrighted material, is not placed on the Internet and will be publicly available only in hard copy form. Publicly available dock et materials are available either electronically at www.regulations.gov or in hard copy at the Water Docket, EPA/DC, EPA West, Room 3334, 1301 Constitution Ave., NW, Washington, DC. This Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The telephone number for this Public Reading Room is (202) 566-1744, and the telephone number for the Water Docket is (202) 566-2426.

FOR FURTHER INFORMATION CONTACT: Brenda D. Parris, Technical Support Center, Standards and Risk Management Division, Office of Ground Water and Drinking Water, United States Environmental Protection Agency, Office of Water, 26 West Martin Luther King Drive (MS 140), Cincinnati, Ohio 45268; telephone (513) 569-7961; or email at parris.brenda@epa.gov. For general information, contact the Safe Drinking Water Hotline. Callers within the United States may reach the Hotline at (800) 426 -4791. The Hotline is open Monday through Friday, excluding legal holidays, from 10:00 a.m. to 4:00 p.m., Eastern time. The Safe Drinking Water Hotline may also be found on the Intern et at http://water.epa.gov/drink/contact.cfm

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SUPPLEMENTARY INFORMATION:
I. General Information*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 4 of 108 A. Does This Action Apply to Me? Entities regulated by this action are public water systems (PWSs). All large community and non-transient non-community water systems serving more than 10,000 people are required to monitor. A community water system (CWS) means a PWS , which has at least 15 service connections used by year-round residents or regularly serves an average of at least 25 year -round residents. A n on-transient non- community water system ( NTNCWS ) means a PWS that is not a
CWS and regularly serves at le ast 25 of the same people over six months per year. Only a nationally representative sample of “ small ” community and non-transient non-community systems serving 10,000 or fewer people are required to monitor for the chemical analytes (see USEPA, 2001 for a description of the statistical approach for the nationally representative sample)

. EPA will pay for the analysis of samples collected by these small systems. Transient non-community water systems (T NCWS ) (i.e., systems that do not regularly serve at least 25 of the same people over six months per year) are not required to monitor for the chemical analytes

. However, transient ground water systems serving 1,000 or fewer people may be selected for virus monitoring. If selected, these systems are required to permit EPA to sample and analyze for List 3 contaminants and pathogen indicators. EPA w ill pay for all sampling and analysis costs associated with virus monitoring at these small systems

. Ex hibit 1 summarizes UCMR 3 applicability by system type and size.

Exhibit 1 : Applicability of UCMR 3 to Water Utilities by System Type and Size UCMR 3 Assessment Monitoring System Type System Size 1 Serving > 10,000 Serving ≤ 10,000*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 5 of 108 CWS & NTNCWS Requires all systems to monitor for List 1 chemicals Requires 800 randomly selected systems to monitor for List 1 chemicals. EPA will pay for the analysis of samples

. TNCWS No requirements No Requirements UCMR 3 Pre
- Screen Testing System Type System Size 1 Serving > 1,000 Serving ≤1,000

CWS, TNCWS & NTNCWS No requirements Requires 800 randomly selected systems to permit EPA to sample and analyze List 3 microbes. The selected systems will be served by nondisinfecting ground water wells in vulnerable areas . EPA will pay for the analysis of samples

. 1. Based on the retail population , as indicated by SDWIS/Fed on December 31, 2010

.
State s, Territories, and Tribes with primary enforcement responsibility (primacy) to administer the regulatory program for PWSs under SDWA may participate in the implementation of UCMR 3 through Partnership Agreement s (P As ). These p rimacy agencies may choose to perform the required analysis of samples collected for UCMR 3; however, the PWS remains responsible for compliance with this rule

. Regulated categories and entities are identified in the following exhibit.

Category Examples of potentially regulated entit ies NAICS a State, Local, & Tribal Governments States, local and Tribal governments that analyze water samples on behalf of public water systems required to conduct such analysis; States, local and Tribal governments that directly operate community, transient and non-transient non- community water syste ms required to monitor. 924110

Industry Private operators of community and non

- transient non

community water systems required to monitor. 221310*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 6 of 108 Municipalities Municipal operators of community and non

- transient non - community water systems required to monitor. 924110

a NAICS = North American Industry Classification System

This exhibit is not exhaustive, but rather provides a guide for readers regarding entities that may be regulated by this action. This exhibit lists the types of entities that EPA is now aware may potentially be regulated by this action. Other types of entities not listed in the exhibit could also be regulated. To determine whether your facility is regulated by this action, you should carefully examine the definition of PWS in §141.2 of Title 40 of the Code of Federal Regulations, and applicability criteria in §141.40(a)(1) and (2) of this action. If you have questions regarding the applicability of this action to a particular entity, consult the person s listed in the preceding F OR FURTHER INFORMATION CONTACT Section

.

B. Copies of This Document and Other Related Information This document is available for download at: www.regulations.gov

. For other related information, see preceding discussion on docket.

Abbreviations and Acronyms μg/L Microgram (s) p er Liter
ASDWA Association of State Drinking Water Administrators
AGI Acute Gastrointestinal Illness
CCL Contaminant Candidate List
CFR Code of Federal Regulations*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 7 of 108 CWS Community Water System DQO Data Quality Objectives
DSMRT Distribution System Maximum Residence Time
EO Executive Order
ELISA Enzyme -linked Immunosorbent Assay
EPA United States Environmental Protection Agency
EPTDS Entry Point to the Distribution System
FR Fed eral Register
GC/MS Gas Chromatography/Mass Spectrometry
GWUDI Ground Water Under the Direct Influence of Surface Water
HCFC -22 Chlorodifluoromethane
HP LC /MS/MS High -Performance Liquid Chromatography/Tandem Mass Spectrometry
HRL Health Reference Level
IC/MS Ion Chromatography/Mass Spectrometry
ICR Information Collection Request
IDC I nitial Demonstration of Capability
IHS Indian Health Service
LCMRL Lowest Concentration Minimum Reporting Level
LC/MS/MS Liquid Chromatography /Tandem Mass Spectrometry
LFSM Laboratory Fortified Sample Matrix
LFSMD Laboratory Fortified Sample Matrix Duplicate*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 8 of 108 MDL Method Detection Limit
MRL Minimum Reporting Level
NAICS North American Industry Classification System
NCOD National Drinking Water Contam inant Occurrence Database
ND Not Detected
NTNCWS Non -Transient Non- Community Water System
NTTAA National Technology Transfer and Advancement Act NWQL National Water Quality Laboratory
OMB Office of Management and Budget
PA Partnership A greement PFBS Perfluorobutanesulfonic Acid
PFC Perfluorinated Compounds PFHpA Perfluoroheptanoic Acid
PFHxS Perfluorohexanesulfonic Aci d
PFNA Perfluorononanoic Acid
PFOA Perfluorooctanoic Acid
PFOS P erfluoro o ctanes ulfonic Acid
PT Proficiency T esting
PWS Public Water System qPCR Q uantitative P olymerase Chain R eaction
RFA Regulatory Flexibility Act
SDWARS Safe Drinking Water Accession and Review System*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 9 of 108 SM Standard Methods
SRF State Revolving Fund
SBA Small Business Administration
SDWA Safe Drinking Water Act
SDWIS/ Fed Federal Safe Drinking Water Information System
TNCWS Transient Non- Community Water System
TTHM Total Trihalomethanes
UCMR Unregulated Contaminant Monitoring Regulation
UMRA Unfunded Mandates Reform Act of 1995
VOC Volatile Organic Compound

TABLE OF CONTENTS:
I. General Information
A. Does This Action Apply to Me?
B. Copies of This Document and Other Related Information
II. Statutory Authority and Background
A. What is the statutory authority for UCMR?
B. How does EPA meet these statutory requirements?
III. Summary of This Rule
A. What are the major changes between the proposed and final UCMR 3 rule?
B. Which water systems must monitor
1. Applicability Based on Population Served*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 10 of 108 2. Applicability for Transient Systems
C. Where are samples collected?
1. Entry point to the distribution system
2. Distribution system maximum residence time location
D. What are the UCMR 3 contaminants and associated methods?
1. List compilation
2. Hormones and related methods
3. Metals, chlorate, and related methods
4. Chromium-6 and total chromium, and related methods
5. Viru ses and related methods
E. How are laboratories approved for UCMR 3 monitoring?
1. This rule
2. Summary of major comments
F. How Wer e Minimum Reporting Levels Determined?
1. This rule
2. Summary of major comments
G. What are the UCMR 3 reporting requirements?
1. General Reporting Requirements/SDWARS
2. Sample location and inventory information (zip codes)
3. Disinfectant Type Specifications
4. Reporting schedule
IV. State and Tribal Participation*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 11 of 108 A. Partnership agreements
1. This rule
2. Summary of major comments
B. Governors’ petition and state- wide waivers
1. This rule
2. Summary of major comments
V. Cost and Benefits of This Rule
VI. Statutory and Executive Order Reviews
A. Executive Order 12866: Regulatory Planning and Review and Executive Order 13563: Improving Regulation and Regulatory Review
B. Paperwork Reduction Act
C. Regulatory Flexibility Act
D. Unfunded Mandates Reform Act (UMRA)
E. Executive Order 13132: Federalism
F. Executive Order 13175: Consultation and Coordination with Indian Tribal
Governments
G. Executive Order 13045: Protection of Children from Environmental Health Risks and Safety Risks
H. Executive Order 13211: Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use
I. National Technology Transfer and Advancement Act
J. Executive Order 12898: Federal Actions to Address Envi ronmental Justice in*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 12 of 108 Minority Populations and Low-Income Populations.
K. Congressional Review Act
VII. Public Involvement in Regulation Development
VIII. Reference s

LIST OF EXHIBITS Exhibit 1: Applicability of UCMR 3 to Water Utilities by System Type and Size Exhibit 2: UCMR 3 Final Contaminant Lists Exhibit 3: Timeline of UCMR 3 Activities Exhibit 4: Changes to UCMR 3 between Proposed and Final Rule Exhibit 5a: 30 UCMR 3 Analytes and Methods Exhibit 5b: Total Chromium Monitoring Exhibit 6: Observed Background Levels During MRL Determination Exhibit 7: UCMR 3 Per Respondent Burden and Cost Summary for the ICR Period (2012-2014) Exhibit 8: Number of Publicly- and Privately

- Owned Small Systems Subject to
UCMR 3 Exhibit 9: EPA and Systems Costs for Implementation of UCMR 3 at Small Systems Exhibit 10: UCMR 3 Relative Cost Analysis for Small Publicly

- Owned Systems (2012-2016) Exhibit 11: UCMR 3 Relative Cost Analysis for Small Privately

- Owned Systems (2012-2016)*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 13 of 108 II. Statutory Authority and Background A. What is the statutory authority for UCMR? Section 1445(a)(2) of SDWA, as amended in 1996, requires that once every five years, the United States Environmental Protection Agency (EPA) issue a new list of no more than 30 unregulated contaminants to be monitored b y public water systems (PWSs). It also requires that EPA enter the monitoring data into the Agency’ s National Drinking Water Contaminant Occurrence Database (NCOD). EPA must ensure that only a national ly representative sample of PWSs serving 10,000 or fewer people is required to monitor. EPA must also vary the frequency and schedule for monitoring based on the number of persons served, the source of supply, and the contaminants likely to be found. Section 1445(a)(1) (A) of SDWA, as amended in 1996, requires that every person who is subject to any SDWA requirements establish and maintain such records, make such reports, conduct such monitoring, and provide such information as the Administrator may reasonably require by regulation to assist the Administrator in establishing SDWA regulations. Pursuant to this authority, EPA is also requiring the monitoring of total chromium under this final rule.
B. How does EPA meet these statutory requirements? This final rule fulfills EPA ’s obligation under SDWA by identifying 30 contaminants for monitoring during the third UCMR, referred to as “ UCMR 3.” These contaminants include: 28 chemicals measured using up to seven analytical methods and/or four equivalent consensus organization-developed methods, and two viruses measured using one sample collection and two detection methods. EPA has developed the contaminant list (Exhibit 2) and sampling design for*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 14 of 108 UCMR 3 (2012-2016) with input from both stakeholders and an EPA- State working group.

Exhibit 2 : UCMR 3 Final Contaminant Lists List 1, Assessment Monitoring 1
17

- β

- estradiol bromochloromethane (Halon 1011) 17

- α
- ethynylestradiol (ethinyl estradiol) 1,4

- dioxane estriol vanadium equilin molybdenum
estrone cobalt

testosterone strontium
4- androstene

- 3,17

- dione chromium

- 6 (hexavalent chromium) 2 1,2,3

- trichloropropane c hlorate 1,3

- butadiene perfluorooctanesulfonic acid (PFOS) chloromethane (methyl chloride) perfluorooctanoic acid (PFOA) 1,1

- dichloroethane perfluorononanoic acid (PFNA)

n - propylbenzene perfluorohexanesulfonic acid (PFHxS) bromomethane (methyl bromide) perfluoroheptanoic acid (PFHpA) chlorodifluoromethane (HCFC

- 22) perfluorobutanesulfonic acid (PFBS) List 3, Pre
- Screen Testing 3
enteroviruses n oroviruses 1. M onitoring for total chromium – in conjunction with UCMR 3 Assessment Monitoring – is also required. This monitoring is required under the authority provided in Section 1445 (a)(1)(A) of SDWA

. 2. Chromium

- 6 will be measured as soluble chromate (ion). 3 . Monitoring for microbial indicators – in conjunction with UCMR 3 Pre- Screen Testing – is also required. This monitoring includes sampling for pathogen indicators (i.e. , total coliforms, E.coli , bacteriophage, Enterococci and aerobic spores ). I t is not su bject to the stipulation in Section 1445(a)(2)(B)(i) of SDWA that restricts UCMR co ntaminants to not more than 30

. EPA will pay for all sampling and analysis costs associated with virus and indicator monitoring at these small systems.

This list is the sa me as was provided in the March 3, 2011, proposed rule (76 FR 11713, (USEPA, 2011a)), with the exception that chromium-6 (hexavalent chromium) has been*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 15 of 108 substituted for sec -butylbenzene. In addition, EPA is requiring total chromium monitoring under the auth ority provided in Sec tion 1445 (a)(1)(A) of SDWA

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III. Summary of This R ule Public water systems (PWS) or EPA will conduct sampling and analysis for Assessment Monitoring ( List 1 ) and Pre

- Screen Testing ( List 3 ) contaminants , as applicable, at each PWS subject to this rule during a 12 month period within the 2013 to 2015 timeframe. Preparations prior to 2013 include coordination of laboratory approval, selection of representative samples of small systems, development of State Monitoring Plans, establishm ent of monitoring schedules, and notification of participating PWSs . Exhibit 3 illustrates the major activities that will take place during implementation of UCMR 3.

Exhibit 3 : Timeline of UCMR 3 Activities 2012 2013 2014 2015 2016 After proposed rule publication: Lab approval program begins After applicability date: EPA/State partnership agreements and State monitoring plans developed (inc. national representative sample and List 3 systems ) After final rule publication : Assessment Monitoring List 1 Contaminants + Total Chromium All systems serving more than 10,000;

800 systems serving 10,000 or fewer Complete reporting and analysis of data

Pre
- Screen Testing List 3 Contaminants + Indicator Organisms 800 non-disinfecting ground water systems in vulnerable areas serving 1,000 or fewer*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 16 of 108 Inform PWSs/establish monitoring plans

“Assessment Monitoring” is the largest in scope of the three UCMR monitoring lists or tiers. Under UCMR 3 Assessment Monitoring, 28 “ List 1 ” contaminants will be monitored to assess national occurrence in drinking water. These are the contaminants for which analytical method technologies are well established. The second tier of UCMR is referred to as “ List 2 ” or “ Screening Survey ” monitoring. List 2 contaminants are those with analytical methods that have generally been more recently developed and employ technologies that are not as widely used; therefore laboratory capacity may be insufficient to conduct the larger scale Assessment Monitoring. Unlike UCMR 1 (64 FR 50556, September 17, 1999, (USEPA, 1999b )) and UCMR 2 (72 FR 367 January 4 , 2007, (USEPA, 2007)), UCMR 3 includes no Screening Survey monitoring.

“ Pre

- Screen Testing ,” the third tier of UCMR monitoring is generally designed for “ List 3” contaminants with very new or specialized analytical methods. Under UCMR 3 , a selected set of 800 systems that serv e fewer than 1,000 retail customers and that do not disinfect are required to assist EPA in sampling their system for two viruses on List 3 and the associated pathogen indicators (i.e., total coliforms, E.coli , bacteriophage, Enterococci and aerobic spores). This requirement includes community and non-transient, non- community water systems and transient systems.*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 17 of 108 EPA will pay for the sample kit preparation, sample shipping fees, and analysis costs to minimize the impact of the rule on small systems (those serving 10,000 or fewer people). In addition, no small system will be required to monitor for both List 1 and List 3 co ntaminants

. Large systems (those serving more than 10,000 people) will pay for the cost of shipping and laboratory testing for their List 1 analyses

. The data collected through the UCMR program are being stored in NCOD to facilitate analysis and review of contaminant occurrence , guide the conduct of the C ontaminant C andidate
L ist ( CCL ) process and support the Administrator in making regulatory decisions for contaminants in the interest of protecting public health, as required under SDWA Section 1412(b)(1). Results of UCMR 1 and 2 monitoring can be viewed by the public at EPA’ s UCMR web site: http://water.epa.gov/lawsregs/rulesreg s/sdwa/ucmr/data.cfm

.

A. What are the major changes between the proposed and final UCMR 3 rule ? EPA published “Revisions to the Unregulated Contaminant Monitoring Regulation for Public Water Systems; Proposed Rule,” on March 3, 2011 (76 FR 11713, ( USEPA, 2011a )). EPA received input from 53 public commenters. After considering the comments , EPA added chromium-6 to the list of contaminants to be monitored under UCMR 3 and removed sec butylbenzene. EPA revised or clarified requirements pertaining to UCMR appl icability criteria, reporting, monitoring and quality control. Exhibit 4 provides a summary of these changes and a listing of the corresponding preamble section that provides a more detailed discussion of the revisions and related public comments. Sections III.B

- G summarize the different aspects of this rule and the associated major comments received in response to the proposed rule. EPA has*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 18 of 108 compiled a more detailed document containing all public comments and EPA’s responses entitled: “ UCMR 3 Public Comments and Responses,” which can be obtained by going to http://www.regulations.gov , and searching for Docket ID No. EPA- HQ

- OW -2009-0090.

Exhibit 4: Changes to UCMR 3 between Proposed and Final Rule

Rule Section Description of Change Corresponding Preamble Section Number Title/Description

141.35 (c)(1) and (d)( 1) Data elements Revise zip code reporting to include only the zip codes for all customers served, rather than those associated with each sampling point III.G.2 Sample location and inventory information ( z ip codes) 141.35(c)(6)(ii) and 141.40(a)(5)(vi) Reporting schedule Change laboratory reporting time to 90 days , rather than 60 days III.G.4 Reporting schedule 141.40(a) (2) (i)(A) and (a) (2)(ii)(A); and 141.40(a) (3) Table 1 Analytes to be monitored and related specification Add chromium

- 6; remove requirement to monitor for sec butylbenzene ; require total chromium monitoring un der SDWA Section 1445 (a)(1)(A) III.D .4 Chromium

- 6 and t otal c hromium, and related methods III.D.1 List compilation

141.35(c)(2) Sample location and inventory information Large systems must provide sample location and inventory information to EPA by October 1, 2012 III.G.4 Reporting schedule

141. 40 (a )( 3) Table 1, footnote c and 141.40 (a)(4)(i) (C) Distribution system maximum residence time (DSMRT) sample location Revise definition of DSMRT sample required for specific List 1 contaminants III.C Where are samples collected? III.D.3 Metals, chlorate, and related methods 141.35(c)(5)(i) and 141.40 (a)(4)(i) General rescheduling notification Large systems may independently change List 1 monitoring schedule prior to October 1, 2012 III.G.4 Reporting schedule

141.35(c)(3) Ground water representative sampling locations Large systems may submit representative sampling plan proposals or changes to existing plans by June 1, 2012 III.C Where are samples collected? III.G.4 Reporting schedule 141.40(a)(3) Table 1 footnote c Representative in take Systems that purchase water from the same wholesaler may sample from a representative intake III.C Where are samples collected?

B. Which water systems must monitor*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 19 of 108 1. Applicability Based on Population Served
a. This rule This rule requ ires that Assessment Monitoring (for List 1 contaminants) be conducted by all large community and non-transient, non-community water systems serving more than 10,000 people, and a nationally representative sample of 800 small water systems serving 10,000 o r fewer people (as indicated by Federal Safe Drinking Water Information System ( SDWIS/Fed ) on December 31, 2010). Transient non- community water systems are excluded from Assessment Monitoring. In contrast to implementation of UCMR 1 and 2 monitoring, those systems that purchase all of their finished water from another system are not excluded from the requirements of UCMR 3 . All systems serving more than 10,000 retail customers must monitor.
b. Summary of major comments EPA received six (6) comments concerni ng UCMR monitoring based on retail population served. The commenters all agreed that applicability should be based on retail population, although some wanted to exclude those who purchas e their water from that applicability. I n UCMR 1 and 2, systems that purchased 100% of their water were excluded from monitoring, making estimates of exposure more difficult because many of these purchasing systems represented high -population areas. For UCMR 3, systems that purchase 100% of their water and serve greater than 10,000 people are required to monitor. Wholesa lers that have a retail population of 10,000 or below are only required to monitor if they are selected as part of the nationally representative sample of small systems for any list of UCMR contaminants. This should greatly improve exposure estimates for UCMR 3 since exposure estimates will be based on where the water is consumed rather than where it is sold.
Some c ommenters also expressed concern that this applicability change could add an*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 20 of 108 estimated 1,250 systems to the list of those that need to monitor and suggested that this would represent a substantial increase in burden to the drinking water industry. To mitigate the burden, EPA is allowing those systems that purchase water with multiple connections from the same wholesaler to select a representative connection for sampling . See Section III.C.1.a for further discussion.
2. Applicability for Transient System s
a. This rule Under UCMR 1 and 2, transient non- community water systems were specifically exempted from monitoring. UCMR 3 now requires participation by transient systems that are selected for Pre -Screen Testing for List 3 contaminants. Under UCMR 3, EPA is conducting PreScreen Testing for e nterovirus and norovirus, as well as related pathogen indicators, at selected undisinfected ground water systems that serve 1,000 or fewer customers. EPA is including transient systems among the candidate systems – and focusing on viruses at those systems – since viruses are acute pathogens and exposure through a one- time ingestion (e.g. , at a transient system) is of potential health concern

. Under 141.40(a)(1) and 141.40(a)(2)(ii)(C), if any system (including transient systems) is notified by EPA or its St ate that it has been selected for Pre

- Screen Testing , the system must permit EPA (at EPA ’s expense) to sample and analyze for List 3 contaminants and pathogen indicators (i.e., total coliform s, E. coli , bacteriophage, Enterococci and aerobic spores).
b. Su mmary of major comments EPA received two comments on including transient non-community systems for List 3 monitoring. One fully supported thei r inclusion, and the other expressed concern that EPA would not be able to adequately fund the collection and processing of these samples. EPA is confident*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 21 of 108 that it has budgeted sufficient funds to support these activities. As the second commenter noted, transient systems represent a substantial number of the syste ms se rving less than 1,000
customers; therefore, the sampling of these potentially vulnerable systems for these acute pathogens is considered important.

C. Where are samples collected? 1. Entry point to the distribution system a. This rule As was the case under UCMR 2, UCMR 3 samples will be collected at entry points to the distribution system (EPTDSs). PWSs may perform sampling at representative sampling locations in two cases:

**•** Demonstrating Representative Ground Water Sampling Locations : Under this rule, large systems that use ground water sources and have multiple EPTDSs can, with prior approval, conduct monitoring at representative sampling locations rather than at each EPTDS. To monitor at representative EPTDSs, large systems must meet the criteria specified in §141.35(c)(3) and receive approval from EPA or the State. Changes to the rule language clarify that when identifying a representative well, the well must be representative of the highest producing (based on annual volume) and most consistently active w ells. In addition, the representative well must be in use at the scheduled sampling time. A n alternative location must be sampled if the representative EPTDS is not available at the time of scheduled sampling

. This rule establishes a deadline of June 1, 2012 for submission of new proposals or updates to existing plans. See Section III.G.4*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 22 of 108 for further discussion.

**•** Representative Intakes from Wholesaler : As specified in §141.40(a )(3) Table 1, footnote

c, s ystems that purchase water with multiple c onnections from the same wholesaler may select one representative connection from that wholesaler for UCMR sampling

. If a PWS chooses to select a representative intake, each representative intake must receive water from the same source. Additionally, if a PWS chooses to select a representative intake, it must choose a sampling location that represents the highest volume EPTDS connection and is in use at the time of schedule sampling . If the connection initially selected as the representative EPTDS is not available at the time of scheduled sampling, an alternate representative connection must be sampled.
b. Summary of major comments Five commenters expressed support for EPA ’ s proposal regarding representative sampling points, and representative intakes for P WSs with multiple connections from the same wholesaler; commenters cited cost savings as a benefit of this approach. One commenter also suggested that EPA ’ s approach to representative sampling locations should provide additional flexibility in cases where multiple water systems are receivin g water from the same wholesale provider. EPA acknowledges that there are many unique situations with the purchase and sale of drinking water at the wholesale level. In t his final rule, EPA has provided clarifying languag e in §141.40(a)(3) Table 1, footnote c, specifying that a PWS may select a representative intake from a given wholesaler . EPA is available to advise PWSs regarding choos ing the most appropriate sampling site, based on their purchasing situation.*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 23 of 108 2. Distribution system maximum residence time location a. This rule This rule requires systems that participat e in Assessment Monitoring also sample for total chromium, chromium-6, cobalt, molybdenum, strontium, vanadium, and chlorate both at EPTDSs and in th e distribution system. This rule requires systems to collect the samples for these analytes at their distribution system maximum residence time (DSMRT) location(s), (§§141.40(a)(3) Table 1, footnote c and 141.40(a)(4)(i)(C)). For clarity, EPA deleted the U CMR reference to the DSMRT specifications under the Stage 1 disinfection byproducts rule at §141.132(b)(1)(i). EPA now defines DSMRT under UCMR as an active point ( i.e., a location that currently provides water to customers) in the distribution system where the water has been in the system the longest relative to the EPTDS . S ystem s that are subject to the Stage 2 D isinfection By-Products Rule should use their total trihalomethanes (( TTHM ) highest concentration sampling site(s) a s their DSMRT sampling site(s) (USEPA, 2003).
b. Summary of major comments As described in greater detail in Section III.D.3., “m etals , chlorate, and related methods,” several commenters suggested that EPA had provided insufficient rationale for requiring DSMRT sampling for cobalt, molybdenum, strontium, vanadium, and chlorate. As elements that may occur in water both naturally, or through industrial activities, cobalt, molybdenum, strontium, and vanadium are expected to be commonly- detected in drinking water. EPA believes these metals may be incorporated into pipe deposits and subsequent erosion and/or dissolution may result in water -borne concentrations that differ between the DSMRT and the EPTDS. Regarding chlorate, the use of disinfectants , including use of hypochlorite, chloramines, chlorine dioxide, and ozone can result in chlorate formation. The presence of residual disinfectant in the*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 24 of 108 distribution system and chlorine boosters within the distribution system may result in increases in chl orate concentrations at the DSMRT relative to the EPTDS.

D. What are the UCMR 3 contaminants and associated methods? 1. List compilation
a. This rule EPA is maintaining the list of contaminants and methods proposed for monitoring with the exception of substituting chromium- 6 for sec -butylbenzene ( see Exhibit 5 a)

. EPA is also requiring PWSs to monitor for total chromium concurrent ly with all chromium -6 monitoring ( Exhibit 5 b). T he additional data generated by side

- by

- side mea surements of chromium-6 and total chromium will provide valuable information on relative occurrence and the utility of monitoring for total chromium as a surrogate for chromium -6.

Exhibit 5a: 30 UCMR 3 Analytes and Methods 7 Hormones using EPA Method 539 (LC/MS/MS) 1 : 17

- β

- estradiol estrone 17

- α
- ethynylestradiol (ethinyl estradiol) testosterone estriol (16

- α
- hydroxy

- 17

- β

- estradiol) 4- androstene

- 3,17

- dione equilin 8 Volatile Organic Compounds (VOC) using EPA Method 524.3 (GC/MS) 2 : 1,2,3

- trichloropropane bromomethane (methyl bromide) 1,3

- butadiene n - propylbenzene chloromethane (methyl chloride) chlorodifluoromethane (HCFC

- 22) 1,1

- dichloroethane bromochloromethane (Halon 1011) Synthetic Organic Compound using EPA Method 522 (GC/MS) 3 : 1,4

- dioxane 4 Metals using EPA Method 200.8 (IC/MS) 4 or alternate SM 5 or ASTM Methods 6 :*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 25 of 108 cobalt strontium molybdenum vanadium Oxyhalide Anion using EPA Method 300.1 (IC/Conductivity) 7 or alternate SM 8 or ASTM Methods 9 :

c hlorate 6 Perfluorinated Chemicals using EPA Method 537 (LC/MS/MS) 10 : perfluorooctanesulfonic acid (PFOS) perfluorohexanesulfonic acid (PFHxS) perfluorooctanoic acid (PFOA) perfluoroheptanoic acid (PFHpA) perfluorononanoic acid (PFNA) perfluorobutanesulfonic acid (PFBS) Chromium
- 6 using EPA Method 218.7 (IC/Conductivity) 11 : chromium -6 2 Viruses (see Section III.D.5 for methods discussion): 12 enterovirus norovirus Exhibit 5b : Total Chromium Monitoring Total Chromium using EPA Method 200.8 (IC/MS) 4 or alternate SM 5 or ASTM Methods 6 : total chromium 1. EPA Method 539 (LC/MS/MS) (USEPA, 2010 e ) 2. EPA Method 524.3 (GC/MS) (USEPA, 2009a) 3. EPA Method 522 (GC/MS) (USEPA, 2008) 4. EPA Method 200.8 (ICP/MS) (USEPA, 1994) 5. SM 3125 (SM, 21 st Ed., 2005 ) 6. ASTM D5673

- 10 (ASTM, 2010) 7. EPA Method 300.1 (IC/Conductivity) (USE PA, 1997) 8. SM 4110D (SM, 21 st Ed., 2005) 9. ASTM D6581

- 08 (ASTM, 2008) 10. EPA Method 537 (LC/MS/MS) (USEPA, 2009b) 11 EPA Method 218.7 (IC/Conductivity) (USEPA, 2011 b) 12. Monitoring also includes sampling for pathogen indicators (i.e., total coliforms, E.coli , bacteriophage, Enterococci and aerobic spores ) . EPA will pay for all sampling and analy sis costs associated with monitoring at these small systems.

b. Summary of major comments C ommenters who expressed an opinion about the proposed UCMR 3 analytes were generally supportive. S everal commenters suggested that cyanobacterial toxins be added to the list of analytes. EPA agrees that cyanobacterial toxins are of significant interest for future drinking water monitoring. However, EPA currently does not have an available drinking water method for analysis of cyanobacterial toxins. W hile enzyme -linked immunosorbent assays (ELISA) and high

- performance liquid chromatography with UV detect ion (HPLC/UV) methods have been published (Howard and Boyer, 2007), they do not provide the level of specificity needed for UCMR monitoring. The high -performance liquid chromatography/ tandem mass*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 26 of 108 spectrometry (HPLC/MS/MS) methods for cyanobacterial toxins that have been published (Oehrle et al., 2010), do not provide su itable accuracy and precision

. EPA has conducted and will continue to conduct methods development research for cyanobacterial toxins both in -house and in cooperation with other laboratories.

2. Hormones and related methods
a. This rule EPA is finalizing the requirement for monitoring of the hormones as proposed : 17- β

estradiol; 17- α - ethynylestradiol; estriol ; equilin; estrone; testosterone; and, 4-androstene-3,17- dione.
b. Summary of major comments Two major issues concerning the hormones were raised by commenters. The first was a concern that other than 17

- α - ethynylestradiol , the hormones all occur naturally. Based on the low minimum reporting levels (MRLs) specified in this rule , these c ommenters were concerned that there may be issues with false positi ves due to background levels of these compounds from samplers

. The ranges of blank results observed during the determination of MRLs are contained in Exhibit 6. In all cases the laboratories easily met the requirement that the concentration of the analytes observed in the blank must be less than one-third of the MRL. In the “ worst case ” the observed blank level equal ed one-eighth the MRL. EPA is requiring the collection of field blank samples for UCMR 3 and , to minimize the potential issue of field blank and sample contamination, will provide instructions to both the samplers and the laboratory personnel to

wear nitrile gloves when collecting or handling samples for the hormones. These details are*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 27 of 108 specified in EPA ’ s technical manual titled: “UCMR 3 Laborat ory Approval Requirements and Information Document” (USEPA, 2012d).

Exhibit 6 : Observed Background Levels During MRL Determination

Analyte UCMR MRL (μg/L) Laboratory 1 (μg/L) Laboratory 2 (μg/L) Laboratory 3 (μg/L) 17

- β

- estradiol 0.0004 ND

– 0.00006 ND ND

– 0.00005 17

- α
- ethynylestradiol 0.0009 ND

– 0.00007 ND

– 0.00008 ND

– 0.0002 e striol 0.0008 ND

– 0.00007 ND ND

– 0.00006 e quilin 0.004 ND

– 0.00002 ND ND

– 0.0005 e strone 0.002 ND

– 0.0001 0.00001

– 0.00003 0.02

– 0.0002 t estosterone 0.0001 ND ND ND

– 0.00001 4

- androstene

- 3,17

- dione 0.0003 ND ND ND

– 0.000008 ND = Not Detected

EPA also stipulated in the rule that it will evaluate the situation after six months of monitoring. If at that time, the data indicate that excessive resampling is occurring, EPA will establish alternative MRLs and will notify all affected PWSs and laboratories. The second issue concerned whether all of the proposed hormones should be monitored (versus a subset of them). There was no consensus among the commenters a s to what the “subset” should be. Some commenters suggested that monitoring be limited to the five (5) proposed hormones that are also listed on the final CCL 3 ( 17- β -estradiol, 17- α - ethynylestradiol, estriol, equilin and estrone). EPA believes that monito ring fortestosterone and 4-androstene3,17-dione is also justified. A number of articles have been published that show the occurrence of testosterone and 4-androstene-3,17-dione in surface waters:

**•** National Surface Water Reconnaissance (1999 – 2000): detec ts of testosterone in 2 (2.8%) of 70 samples at a median concentration of 0.116 μg/L and a maximum concentration of 0.214 μg/L (Kolpin et al., 2002).*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 28 of 108 **•** California, Rivers, Irrigation Canals, and Tile Drains (2003 – 2005): detects of
testosterone in 2 (18%) of 11 river samples at a maximum concentration of 0.0006 μg/L; detects in 4 (27%) of 15 irrigation canal samples at a maximum concentration of 0.0019 μg/L; detects in 2 (33%) of 6 tile drain samples at a maximum concentration of <0.0003 μg/L (Kolodziej et al., 2004).

**•** California Surface Waters (2005 – 2006): detects of 4-androstene-3,17-dione in 16 (18%) of 89 grazing rangeland surface water samples at a maximum concentration of 0.044 μg/L (Kolodziej and Sedlak, 2007).

In addition, testosterone and 4-andros tene -3,17-dione have been shown to be relatively resistant to oxidation ( Mash et al ., 2010).

3. Metals , chlorate, and related methods a. This rule This rule requires that samples for the metals – chromium-6, total chromium, cobalt, molybdenum, strontium, and vanadium – as well as chlorate, be collected at one distribution system sampling point per treatment plant (i.e., at the DSMRT) in addition to sampling at the
EP T DS

. DSMRT samples must be collected at a location that represents the maximum residence time in the distribution system (§§141.40(a)(3) Table 1, footnote c and 141.40(a)(4)(i)(C)). (As noted in Section III.C.2.a of this preamble, EPA clarified the DSMRT specifications and deleted the direct DSMRT reference under the Stage 1 disinfection byproducts rule at §141.132(b)(1)(i).) EPA is requiring that chlorate samples be collected at both the EPTDS and DSMRT locations to permit the Agency to evaluate if chlorate occurs as an oxyhalide disinfection by-*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 29 of 108 product b. Summary of major comments Eight commenters suggested that further justification was needed to support monitoring cobalt, molybdenum, strontium, and vanadium at the DSMRT. Three commenters also made similar comments regarding chlorate. Research indicates that vanadium can become incorporated in the corrosion products in iron pipes used for drinking water distribution. As a result, vanadium may be released via dissolution and/or erosion of the mineral deposits that form inside many iron distribution pipes. Gerke et al . (2010) cite research that indicates that relatively minor scouring of these deposits can result in water concentrations of vanadium in excess of 15 μg/L. Similar findings were published by the Water Research Foundation ( Friedman et al ., 2009). The authors reported vanadium in scaling from several different distribution systems. Molybdenum has been identified as being among the heavy metals that can be mobilized from reservoir sediments containing iron and aluminum oxides and hydroxides. Fluctuations in pH of approximately 0.2 pH units were sufficient to considerably affect the release of previously absorbed molybdenum (Friedman et al. , 2009). Although such findings for cobalt and strontium are not available in the scientific literature, these two elements c ommonly occur in drinking water. As a result, EPA believes that incorporation of cobalt and/or strontium into pipe deposits within a distribution system could result in mobilization of these metals into drinking water within the distribution system via dissolution and/or erosion. Strontium has been found in greatest amounts in calcium- rich minerals and sediments due to similarities in atomic radii (Fairbridge, 1972) . In addition, Friedman et al . (2009) report calcium to be the fourth most concentrated eleme nt found in pipe*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 30 of 108 deposit samples. Thus, erosion and/or dissolution of pipe deposits within the distribution system may affect human exposure levels for cobalt, molybdenum, strontium, and vanadium. The presence of residual disinfectant in the distribution s ystem may result in increases in chlorate concentrations at the DS MRT relative to the EPTDS. The following studies on chlorate formation have linked its presence in treated drinking water to the use of several disinfection
processes:

**•** the generation of chlorine dioxide from chlorite and free chlorine (Gordon et al., 1990; Bolyard et al., 1993; Gallagher et al., 1994);

**•** the generation of chlorine dioxide from chlorite and hypochlorite (Gallagher et al., 1994);

**•** chlorine dioxide oxidation by residual free chlorine (Gordon and Tachiyashiki, 1991; Bolyard et al., 1993);

**•** transition metal -catalyzed free chlorine decomposition during disinfection (Gordon et al., 1995);

**•** base -catalyzed disproportionation of chlorine dioxide (USEPA, 1999a ; Gallagher et al., 1994);

**•** photodecomposition of chlorine dioxide ( Rice and Gomez -Taylor, 1986; Bolyard et al., 1993; Gallagher et al., 1994; Bergmann and Koparal, 2005);

**•** use of chlorate-contaminated hypochlorite solutions – chlorate can come from either the impurity of the original stock solution or decomposition during storage (Bolyard et al., 1992; Bolyard et al., 1993; Gordon et al., 1993; Gordon et al., 1995; Gordon et al., 1997; USEPA, 1999a; WHO, 2005; Snyder et al., 2009 ; Stanford et al., 2011 );*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 31 of 108 **•** use of ozone with residual chlorine (Siddiqui, 1996; von Gunten, 2003); and

**•** use of electrochemical disinfection processes (Czarnetzki and Janssen, 1992; Bergmann and Koparal, 2005).

4. Chromium -6 and total chromium, and related methods
a. This rule While EPA did not include chromium-6 in the proposed list of chemicals for UCMR 3 monitoring, EPA did request comment on whether the Agency shou ld include it in the final rule due to the concerns about its potential occurrence in public water supplies

. EPA also requested comments on whether total chromium should be measured concurrent with chromium-6.
Commenters strongly supported requiring monitoring for both chromium-6 and total chromium. EPA agrees with these commenters and has substituted chromium-6 for sec -butylbenzene
in UCMR 3. EPA also completed the development and v alidation of a revised analytical method for the determination of chromium-6 in drinking water, EPA Method 218.7: Determination of Dissolved Hexavalent Chromium in Drinking Water by Ion Chromatography

. This revised method has been extensively studied both within EPA and ion chromatography manufacturers’ laboratories as well as through external laborator y validation (USEPA, 2011b). EPA is usin g the authority provided in SDWA Section 1445(a)(1)(A) to require monitoring for total chromium in conjunction with the UCMR 3 monitoring of chromium-6. b. Summary of major comments EPA received 30 comments regarding the inclusion of chromium-6 in UCMR 3. Twentyeight of the 30 commenters supported inclusion. The other two suggested that a health risk from*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 32 of 108 drinking water exposure had not been conclusively established, that regional levels of total chromium in drinking water are very low, and that speciation would not be beneficial. The Ag ency believes that the ongoing studies of chromium- 6 toxicity warrant UCMR monitoring at this time. EPA believes that collecting national occurrence data will provide beneficial information to the Agency regarding how best to protect human health. EPA’s second Six- Year Review of National Primary Drinking Water Regulations s ( USEPA, 2010d ) indicated that the levels of total chromium warrant further investigation of chromium-6 occurrence . Chromium can enter the environment from both natural and industrial sources; thus the distribution of both total chromium and chromium-6 may vary based on regional geology and regional industrial activity. Part of the goal of UCMR is to assess the national distribution of the contaminants selected.
Commenters who supported the inclusion of chromium- 6 cited two primary reasons for its inclusion in UCMR 3:

**•** generating national occurrence data in UCMR 3 will avoid potential delays in any possible regulatory action;

**•** monitoring for both total chromium and chromium- 6 may allow f or determining a relationship between the two species, allowing for possible use of total chromium monitoring, which is less costly and has better holding time requirements, as a surrogate for chromium-6 monitoring. While generally supporting chromium-6 monitoring in UCMR 3 , some commenters expressed concern about the current analytical method. The concerns included procedural issues (e.g., field filtration, preservation and holding time compliance ), interferences concerns (e.g., sensitivity and species interconv ersion prior to sample analysis ), the need for ro und-robin testing*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 33 of 108 of the method laboratory capacity , and the need to determine a lowest concentration minimum reporting level (LCMRL) and MRL for chromium-6. Extensive research by EPA, with support
fr om instrument manufacturers and commercial laboratories, addressed the issues of interferences, sensitivity and analyte preservation. EPA Method 218.7 has undergone peer review , and multi-laboratory LCMRL and MRL determinations have been completed ( USEPA, 2011b; USEPA, 2006). Because UCMR is limited by statu te to 30 unregulated contaminants, c ommenters offered a variety of suggestions for which analyte to remove to accom modate chromium-6. Suggestions included dropping one of the metals, hormones, PFCs, or VOCs. Other suggestions included removing “the contaminant with the least chance of being detected during monitoring.” EPA selected sec -butylbenzene, a non- carcinogenic VOC , for removal after considering data submitted by states that indicated a v ery low and declining occurrence rate. EPA also considered the fact that the currently available health reference level , 10.3 μg/L, is well above the reported levels of occurrence in these data (USEPA, 2012c).

5. Viruses and r elated me thods a. This rule EPA is finalizing the requirement for monitoring of the viruses as proposed. This rule requires monitor ing for enter ovirus and norovirus in UCMR 3 via Pre

- Screen Testing of selected undisinfected ground water systems located in karst or fractured bedrock. The monitoring will include 800 PWSs serving 1,000 or fewer customers, including CWSs, and non-transient and transient non- community water system s. Monitoring will also include sampling for pathogen indicators (i.e., total coliforms, E.coli , bacteriophage, Enterococci and aerobic spores). This*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 34 of 108 monitoring will obtain information concerning the occurrence of enterovirus and norovirus for further evaluation, and provide EPA with a better understanding of the co- occurrence of pathogen indicators and viruses. Enterovirus es will be monitored using one method that has two detection assays. The first is a cell culture assay also used in the Information C ollection Rule survey conducted by EPA (61 FR 24353, May 14, 1996 (USEPA, 1996)), with one change; the Virosorb 1- MDS filter will be replaced by the NanoCeram ® filter, which will significantly reduce sampling cost. The
NanoCeram ® filter has proven to be as effective as Virosorb 1- MDS filter for the recovery of enteroviruses (Karim et al., 2009) and norovirus es (Gibbons et al., 2010). The second assay is quantitative polymerase chain reaction (qPCR) based , and detects the viral nucleic acid. Norovirus es will only be monitored using qPCR, as there is no cell culture method avai lable. Both norovirus and enterovirus qPCR will be performed per the protocol in Lambertini et al. (2008). The qPCR primers and probe for genogroup I norovirus will be as referenced in Jothikumar et al. (2005), while genogroup II Norovirus primers and pro be will be as referenced in Ando et al. (1995). Primers and probe referenced in De Leon et al. (1990) and Monpoeho et al. (2000) will be used for enterovirus qPCR.
b. Summary of major comments Several commenters expressed concern about us ing Method 1615 for monitoring viruses because it has not undergone multi-laboratory validation. EPA notes, however, that individual elements of the method have been used by many researchers worl dwide, and the culture assay is, with the exception of a new filter, identical to the Information Collection Rule validated method (FR 24353, May 14, 1996 (USEPA, 1996)). The complete method is published and has*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 35 of 108 undergone thorough peer review as per protocols established by EPA’s National Exposure Research Laboratory and consistent with “The Handbook for Preparing ORD Reports” (USEPA, 1995). The method has undergone validation at EPA’s laboratory, has built in quality controls for PCR inhibition, and has positive and negative controls to identify false negative and positive
assays . R esults from the analysis of initial and ongoing positive and negative proficiency testing (PT) samples will ensure the ability of analysts to perform the method

. Several comment er s question ed EPA ’s use of Borchardt ’ s (2008) data as the basis for including viruses in UCMR 3, since that work has not been published or undergone peer review. In his study, Borchardt sampled wells from 14 communities in Wisconsin for the presence of enteroviruses and noroviruses. The initial ente ric virus RT

- qPCR assay results ar e published in a peer reviewed journal ( Hunt et. al, 2010 ). Borchardt’ s work showed a statistically significant correlation between viral qPCR and self

- reported AGI (acute gastrointestinal illness) in the population served. Borchardt ’s work is also one of the very few studies to assess presence of enteric viruses in undisinfected ground water systems. EPA expects that complete results from Borchardt ’s work will be published in a peer reviewed journal in the near future. The study results have also been pres ented at numerous scientific conferences as well as in testimony to the Wisconsin State Senate. A project advisory committee comprised of epidemiologists from the University of California, Berkeley, Michigan State University and the University of Washington provided additional peer review comments during the study planning and data analysis stages. A few commenters expressed concern s as to whether a survey of 800 undisinfected ground water systems in a sensitive hydrogeology would be nationally representati ve, noting that only specific geologic regions within the country would be included in the survey. While EPA*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 36 of 108 acknowledges that the 800 undisinfected ground water systems are only a small subset of the total number of systems in the country, the selection o f 800 PWSs was statistically derived to be nationally representative of those with sensitive hydrogeology. EPA also received c omments regarding how the Agency would use data obtained from a focused and limited occurrence survey, at highly vulnerable and susceptible systems, to provide meaningful data to judge nationwide occurrence and to support regulatory determination. EPA notes that results will provide an understanding of the exposure risks in populations potentially served by a large number of undisinfected systems in karst aquifers nationally. Lastly , some comments addressed the current information on virus-indicator correlation, suggesting that the correlations are weak. EPA notes that most virus-indicator correlation studies have been perform ed in disinfected systems, not undisinfected ground water systems. EPA also notes that the use of multiple indicators in looking at the correlation will make this monitoring more useful.

E. How are laboratories approved for UCMR 3 monitoring? 1. This rule A ll laboratories conducting analyses for UCMR 3 List 1 contaminants must receive EPA approval to perform those analyses. Laboratories seeking approval are required to provide EPA with data that demonstrate their successful completion of an initial demonstratio n of capability (IDC) as outlined in each method, verify successful method performance at the MRLs as specified in this action, and successful ly participat e in an EPA PT program for the analytes of interest. On

- site audits of candidate laboratories may be conducted. Details of the EPA laboratory approval program are contained in the technical manual titled: “ UCMR 3 Laboratory Approval Requirements and Information Document” (USEPA, 2012d). This document will be*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 37 of 108 available on the electronic docket at www.regulations.gov and w ill be provided to laboratories that register for the laboratory approval program. In addition, EPA may supply analytical reference standards of known concentrations for select analytes to par ticipating/approved laboratories, where such standards are not readily available through commercial sources

. Pre

- Screen Testing (List 3) analyses for viruses and related pathogen indicators (i.e., total coliform s, E. coli , bacteriophage, Enterococci , and aerobic spores) are organized and paid for by EPA through direct contract s with microbial laboratories. These laboratories are not required to go through the same formal laboratory approval process as the Assessment Monitoring laboratories; however, they a re subject to an analogous laboratory approval process as part of their direct contracts with EPA.

a. Laboratory Approval Process for UCMR 3 The UCMR 3 laboratory approval program is similar to the approval program under
UCMR 1 and 2. It is designed to assess and confirm the capability of laboratories to perform analyses using the methods listed in §141.40(a)(3), Table 1 , of this final rule. It will assess whether laboratories meet the required equipment, laboratory performance, and data reporting criteria described in this action. This evaluation program is voluntary in that it only applies to laborator ies intending to analyze UCMR 3 samples. However, EPA require s water systems to

use UCMR 3 approved laboratories when conducting monitoring for those anal ytes listed in Table 1 of §141.40(a)(3) of this final rule. A list of laboratories approved for UCMR 3 monitoring is posted to EPA’ s UCMR w eb site: http://water.epa.gov/lawsregs/rulesregs/sdwa/ucmr/ucmr3/laboratories.cfm

. Laboratories are encouraged to apply for UCMR 3 approvals as early as possible, as schedules for large PWS*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 38 of 108 sampling will be completed soon after the final rule is promulgated. The steps for the laboratory approval process are listed in the following paragraphs, b through f. b. Request to p articipate Laboratories must contact EPA and request to participate in the UCMR 3 laboratory approval program. Laboratories must send th eir request to: UCMR 3 Laboratory Approval Coordinator, USEPA, Technical Support Center, 26 West Martin Luther King Drive (MS 140), Cincinnati, OH 45268; or e mail at: UCMR_Sampling_Coordinator@epa.gov . EPA began accepting requests for registration for the List 1 (Assessment Monitoring) methods on March 03,
2011. T he final opportunity for a laboratory to request the necessary registration forms is [INSERT DATE 90 DAYS AFTER PUBLICATION OF THE FINAL RULE ].

c. Registration Each laboratory that wishes to participate in UCMR 3 monitoring must complete a registration form. R egistration information includes the following : la boratory name, mailing address, shipping address, contact na me, phone number, e mail address, and a list of the UCMR 3 methods for which the laboratory is seeking approval. T he registration step provides EPA with the necessary contact information, and ensures that each laboratory receives a customized application package of materials and instructions for the me thods that it plans to use. d. Application p ackage When EPA receives the registration information, a customized application package will be emailed to the laboratory for completion. Information requested in the application includes the following: IDC data , including precision , accuracy and results of MRL studies; i nformation regarding analytical equipment; p roof of current drinking water laboratory certification (for any*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 39 of 108 currently regulated chemical) ; and example chromatograms for each method under review. The laboratory must post UCMR 3 monitoring results (on behalf of its PWS clients) to
EPA ’ s UCMR electronic data reporting system as a condition of maintaining EPA approval.

e. EPA r eview of application p ackage EPA will review the application package and, i f necessary, request follow -up information. The laboratory must s atisfactor ily complet e this portion of the process before they can participate in the UCMR 3 PT program

. f. Proficiency t esting (PT) A PT sample is a synthetic sample containing a concentrati on of an analyte that is known to EPA, but unknown to the laboratory being tested. To complete the initial laboratory approval process, a laboratory must meet specific acceptance criteria for the analysis of a UCMR 3 PT sample( s) for each method for which the laboratory is seeking approval. Initial laboratory approval is contingent upon successful completion of a PT study. EPA will offer two to four opportunities for a laboratory to successfully analyze UCMR 3 PT samples . At least one of these studies will be conducted prior to the publication of the final rule; at least one study will be conducted after publication of the final rule. This will allow laboratories to complete their portion of the laboratory approval process prior to publication of the final rule, and th erefore receive their approval immediately following the publication of the final rule, or to wait until the final rule is published before completing the required laboratory approval analyses. A laboratory must pass one of the PT studies for each analytical method for which they are requesting approval. Laboratories applying for UCMR 3 approval and laboratories conducting UCMR 3 analyses, may be subject to on-site laboratory audits. No PT studies will be conducted after the*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 40 of 108 start of monitoring; however, laboratory audits will be ongoing throughout the entire monitoring period of 2013-2015. Continued laboratory approval is contingent upon successful participation in any audits conducted by EPA.

g. Written EPA approval After laboratories successfully complete steps “b” through “f” of the laboratory approval
process , EPA will send the laboratory a letter listing (a) the method(s) for which approval is pending (if the PT study and laboratory evaluation are conducted prior to promulgation of the final rule) or (b) approval is granted (after promulgation of the final rule). Laboratories receiving a pending approval letter (prior to final rule promulgation) will be considered approved without further action , following promulgation of the final rule.
2. Summa ry of major comments Three commenters suggested that EPA modify the requirements for PT samples in
UCMR 3 by including a round of PT samples during the UCMR 3 monitoring period in addition to the initial ro und of PT samples conducted prior to monitoring. Instead of requiring laboratories to conduct ongoing PT samples, EPA will conduct ongoing laboratory audits similar
to the process under UCMR 2. Ongoing laboratory audits will allow EPA to evaluate each laboratory’s analytical processes for all aspects of sample receipt, storage, processing, analysis and reporting of routine samples. This will provide a better mechanism , compared to an additional PT study, for uncover ing any potential data issues and ensuring that laboratories meet the quality requirements.

F. How Were Minimum Reporting Levels Determined?*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 41 of 108 1. This rule Lowest Concentration Minimum Reporting Levels (L CMRLs ) and Minimum Reporting Levels ( MRLs ) for each analyte were determined through an EPA LCMRL study assessing the data from multiple laboratories prior to publication of the UCMR 3 proposal. The LCMRL is defined as the lowest spiking concentration at which recovery of between 50 and 150% is expected 99% of the time by a single analyst. The LCMRL is estim ated using advanced statistical procedures that have been incorporated into an LCMRL calculator tool that is available on EPA ’ s w ebsite ( http://water.epa.gov/scite ch/drinkingwater/labcert/analyticalmethods_ogwdw.cfm ). The tool estimates a probability distribution for spike recovery as a function of spiking concentration.
MRL
EPA revised the definition of the MRL used in UCMR 2 (72 FR 367, January 4, 2007, (USEPA, 2 007)). The revised definition reflects improvements in the statistical procedures for determining the LCMRL and MRL. These improvements were implemented by EPA to make the models more robust, i.e., so that the models can accommodate a wider range of observ ed
LCMRL data sets (USEPA, 2010f) . The MRL for an analyte measured by a specified analytical method is designed to be an estimate of an LCMRL that is achievable, with 95% confidence, by a capable analyst/laboratory at least 75% of the time. Such a demonstr ation of ability to reliably make quality measurements at the MRL is intended to achieve high quality measurements across the nation’ s laboratories.
In UCMR 3 , EPA estimated the MRL for an analyte/method by obtaining data from several labora tories performi ng corresponding LCMRL studies. These data were used to construct an approximation to the distribution that would result from picking at random a*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 42 of 108 laboratory/analyst proficient in performing the analytical method and having them perform an LCMRL study and c ompute an LCMRL estimate. The strategy for computing the MRL is two

fold. First, for each LCMRL data set, a distribution for repeated LCMRL determinations by the same laboratory/analyst is estimated by generating a large number of simulated values. Second, these values are combined to create an estimated overall distribution. If a result from one of thelaboratories is significantly higher than that of other laboratories, this value would be downweighted using a robust weight function. The resulting weight ed values are used to construct a probability distribution from which the MRL is computed as the 95th percentile.
2. Summary of major comments Several commenters remarked on the complexity of the procedures for determining the LCMRL and the MRL. These commenters were concerned about the amount of time and effort needed to calculate LCMRLs and MRLs. Some suggested that as an alternative, EPA use the procedure developed for consideration by the Clean Water Act as part of the Federal Advisory Commi ttee on Detection and Quantitation. As a point of clarification, EPA notes that laboratories that participate in UCMR 3 do not need to use the LCMRL and MRL procedures. Instead, l aboratories that participate in UCMR 3 will be required to demonstrate their ability to meet the already

- established UCMR 3 analyte MRLs by analyzing reagent water samples spiked at or below the established UCMR 3 MRLs. This initial demonstration of capability ( IDC ) requirement , as described in EPA’ s “ UCMR 3 Laboratory Approval Requirements and Information Document,” is no more complex than determining a Me thod Detection Limit (MDL) (USEPA, 2012d). A di verse selection of laboratories representing different size s, experience and business status were selected to participate in the EPA LCMRL studies (as described previously in this*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 43 of 108 section) . For transparency, EPA will provide summary tables showi ng all LCMRL results for
UCMR 3 in the docket (USEPA, 2012a ). With regard to comments that the MRLs are being set well below health reference levels ( HRLs ) in certain cases, EPA believes that this is appropriate because new health effects data may become available in the future that result in lower HRLs.

G. What are the UCMR 3 reporting requirements? 1. General Reporting Requirements/SDWARS
a. Thi s rule Under this rule, EPA is committed to pre -populating the inventory and monitoring data in the reporting system (Safe Drinking Water Accession and Review System (SDWARS)), using data from UCMR 2 and SDWIS/Fed information. For PWSs subject to UCMR 3 th at have data in SDWARS from UCMR 2 , EPA will transfer data to “ SDWARS 3 ” (i.e., the SDWARS update associated with UCMR 3 ). F or water systems that are new to UCMR , EPA will pull the available information from SDWIS/Fed and coordinate with States and EPA Reg ions for their input where possible. EPA will load the available information into SDWARS 3 prior to the publication of this final rule. PWSs will then have until October 1, 2012, to update, edit, or change their information or monitoring schedule in SDWARS 3 (see Section III.G.4 for further discussion of reporting deadlines). b. Summary of major comments Several commenters expressed concern over possible inefficiencies related to data entry into SDWARS, including concern over duplication of past efforts ( e.g., having to re

- enter*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 44 of 108 information for each sample point for each sampling event) and time spent identifying representative sampling locations at both the EPTDS and DSMRT for UC MR 2. Commenters further noted it would be very helpful if elements that are duplicated for each sample would be automatically pre

- filled in each field once the information was entered the first time. As noted, for UCMR 3, EPA plans to preload as much inventory to SDWARS as possible and is taking commenter suggestions into consideration in its design updates to SDWARS. The pre-loaded data will include representative sampling locations previously identified at the EPTDS and
DSMRT. PWSs will be asked to verif y their inventory in SDWARS and large systems may be required to revise this information once their ground water representative monitoring plan has been approved, depending on the level of their S tate ’s involvement. S ee Section III.G.4 for discussion of reporting deadlines.
2. Sample location and inventory information (z ip codes)
a. This rule This final rule establishes a requirement for reporting zip codes associated with all PWS
customers

. EPA had proposed reporting of sampling point U.S. Postal Service Z ip Codes and the zip codes of all customers served by a given sampling point (as part of the reporting associated with Data Element 4 – Sampling Point Identification Code). Obtaining the zip code of the sampling point was intended to assist with future vulnerability assessments. Zip codes that tie populations served to each sampling point were intended to assist with future occurrence and exposure analyses. However, based on stakeholder concerns about the burden associated with report ing this information and concerns about the usefulness of having the zip code of the sampling point, EPA revised the rule language to establish a requirement of only reporting zip codes for customers served by the PWS . These reporting specifications are now established in*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 45 of 108 §§141.35 (c)( 1) and (d)( 1) for large and small systems, respectively. EPA believes that required reporting of customer zip codes will provide EPA with useful information for future occurrence analyses.
b. Summary of major comments Eight com ments were received regarding the proposed zip code reporting requirements. Most commenters believed that reporting the zip code for each sampling point location would not provide EPA with the information necessary to make future correlations between water quality and the areas served by the water being distributed. After considering public comments,
EPA has revised the reporting requirement to only include the zip codes served by the PWS

.

3. Disinfectant Type Specifications
a. This rule EPA is changing Data Element 6, in Table 1 of 141.35(e). Under UCMR 2, this data element was established to provide information on “ Disinfectant Residual Type ” as it related to monitoring for nitrosamines (part of UCMR 2 Screening Survey monitoring). EPA is modifying the definition of this data element to account for changes to the analyte and monitoring specifications between UCMR 2 and UCMR 3 . This revised definition lists additional disinfectant types to provide more specific information on the sources and types of disi nfectant schemes that may lead to chlorate formation/occurrence in drinking water.
b. Summary of major comments While commenters were supportive of the collection of these data, several commenters noted that the requirement for reporting this data element was unclear. Some commenters noted*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 46 of 108 that PWSs frequently use multiple disinfectants and reporting only one of those would provide an inaccurate assessment of disinfectants being used. Others noted that EPA needed to make sure that PWSs indicate whether their hypochlorite solution was generated on or off site (onsite: essentially no storage of stock solution will be n eeded; offsite: the storage of stock solution will be needed)

. EPA agrees that the presentation of the requirements warranted clarification and has revised the list of disinfectants. EPA will clearly indicate in the data reporting system (SDWARS) that PWSs should identify all of the disinfectants used to treat the water

.

4. Reporting schedule
a. This rule To help ensure that monitoring and reporting are conducted as scheduled, UCMR 3 specifies several deadlines related to initial reporting of inventory and scheduling information, as well as reporting of monitoring data. Several deadlines were newly proposed for UCMR 3 (i.e., not used for UCMR 1 or UCMR 2 ) and finalized in this rule, and some are revised in this final rule to ensure that UCMR 3 is implemented as scheduled. These deadlines are being established to allow EPA enough time to review and process the information, and complete the planning process for UCMR 3 monitoring to begin on January 1, 2013. C hanges in deadlines only affect large systems. There are no changes to small system reporting schedules. The schedule changes that are finalized in t his rule include:

**•** Inventory and Scheduling : L arge systems that are subject to UCMR 3 must report their inventory and sampling location information (141.35(c)(2)), and any proposed changes to their monitoring schedule (141.35(c)(5)(i) and 141.40(a)(4)(i)) no later than October 1,*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 47 of 108 2012. As noted, EPA will load existing information into SDWARS 3 prior to the publication of this final rule. PWSs will have until October 1, 2012 to update, edit, or change their inventory and sample location information or monitoring schedule in
SDWARS 3

.

**•** Ground water representative monitoring plans: As described in 141.35(c)(3), large systems that use ground water sources and that have multiple EPTDSs can, with prior approval, conduct monitoring at representative sampling locations rather than at each EPTDS. For systems that have existing approved representative monitoring plans, their approved sampling location information will be pre-loaded into SDWARS and systems must review and confirm, or update this information by October 1, 2012. This rule establishes a deadline of June 1, 2012 for submi tting a new ground w ater representative plan to be reviewed by the State or EPA.

**•** Monitoring d ata : T his rule establishes two revised deadlines related to reporting of monitoring data : l arge systems must require their laboratories to post data to SDWARS within 90 days of sample collection; and large systems must review, approve, and submit the data to the ir State and EPA within 30 days of when the laboratory posts the data. These time frames are specified in 141.35(c)(6)(ii) and 141.40(a)(5)(vi).
b. Summary of major comments Five comments were received on the reduced laboratory reporting timeframe. Most commenters did not support the 60-day proposed timeframe for laboratories to post data to
SDWARS and expressed several concerns: that laboratories may see increased workload due to additional monitoring; that UCMR 3 methods are not in common use and are very sensitive, so*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 48 of 108 greater validation of results may be required; and that field blank analysis may be required for some methods, resulting in longer turnaround times for sampling results. Commenters did not believe that the reduced reporting timeframe would increase compliance with monitoring schedules. Seven c omments were also received regarding the 30- day proposed timeframe for large PW Ss to review and approve their data. The majority of the commenters requested the timeframe be returned to th e 60 -day period used under UCMR 1 and 2. Commenters believe the shortened timeframe would not give PWSs sufficient time to conduct a full data review and that schedule coordination among multiple staff would be difficult. After considering the public
comments , EPA has increased the laboratory reporting timeframe to 90 days after sample collection and retained the PWS reporting timeframe of 30 days after laboratory posting data

. EPA believes that these turn -around- times are feasible given historical information from
UCMR 2 on laboratory reporting and system approval of data:

**•** Laboratory posting of data to SDWARS : 90% of the data posted by laboratories w ere posted within 92 days of sample collection.

**•** PWS approval of laboratory data: 65% of PWSs chose to explicitly approve their data, as opposed to allowing automatic approval by SDWARS 60 days after laboratory posting of data ; of PWSs that explicitly approved their data, 90% did so within 35 days of the laboratory posting data

.

IV. State and Tribal P articipation A. Partnership agreements 1. This rule*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 49 of 108 Under UCMR 3, States may continue to have a role in rule implementation through Partnership Agreements (PAs) . B ecause specific activities for individual States are identified and established through the PAs, not through rule language, this rule does not contain reference to
PAs. 2. Summary of major comments EPA received no c omments regarding State participation in UCMR 3.

B. Governors’ petition and state
- wide waivers 1. This rule This rule retains the UCMR 1 and 2 language that, consistent with SDWA, allows a minimum of seven State Governors to petition EPA to add contaminants to the UCMR Contaminant list. This rule also retains the UCMR 1 and 2 language that allows States to waive monitoring requirements with EPA approval and under very limited conditions.
2. Summary of major comments EPA received no comments regarding the governor ’ s petition or state

- wide waiver allowances of UCMR 3.

V. Cost and Benefits of This R ule In this rule, EPA finalize s a new set of contaminants for monitoring in the third five- year UCMR monitoring period. UCMR 3 also incorporates modifications to improve the rule design.
UCMR 3 Assessment Monitoring (for List 1 contaminants) will be conducted from January 2013 through December 2015 by 800 systems serving 10,000 or fewer people, and by all systems serving more than 10,000 people. The 800 small systems will be randomly selected fo r List 1*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 50 of 108 monitoring. The Pre-Screen Testing for List 3 contaminants will also be conducted from January 2013 through December 2015 in 800 undisinfected ground water systems serving 1,000 or fewer persons (different systems than those selected for List 1 monitoring). It is assumed for this cost estimate that one- third of systems will monitor during each of the three monitoring years. Labor costs pertain to systems, States, and EPA. They include activities such as reading the regulation, notifying systems selected to participate, training water system staff on sample collection procedures, sample collection, including travel time to collect samples, data review, reporting, and record keeping. Non- labor costs will be incurred primarily by EPA and by large PWSs . They include the cost of shipping samples to laboratories for testing and the cost of the actual laboratory analyses.
In this rule , EPA specifie s seven EPA -developed analytical methods and four equivalent consensus organization developed methods to monitor for 28 UCMR 3 chemical contaminants, and two viruses for a total of 30 contaminants . While this preamble also describes the analytical methods that w il l be used for virus monitoring, the rule does not address these methods. Laboratory approval for virus monitoring is not addressed since all of the analyses for the two viruses will be conducted in laboratories under EPA contract and at EPA’ s expense. E stimated system and EPA costs are based on the analytical costs for all UCMR 3 methods. With the exceptio n of Methods 200.8 and 300.1, these methods are comparatively new and w il l not coincide with other compliance monitoring (i.e. , no cost savings for concurrent monitoring can be realized). Laboratory analysis and shipping of samples account for approxim ate ly 89% of the total national cost for UCMR 3 implementation. These costs are calculated as follows: the number of*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 51 of 108 systems, multiplied by the number of sampling locations, multiplied by the sampling frequency, multiplied by the unit cost of laboratory analysis. Under UCMR 3 , for List 1 Assessment Monitoring, surface water (and g round water under the direct influence of surface water ( GWUDI )) sampling points w ill be monitored four times during the applicable year of monitoring, and ground water sample points w ill be monitored twice during the applicabl e year of monitoring. Systems w ill monitor for the metals – cobalt, molybdenum, vanadium, strontium, chromium-6, and total chromium – as well as chlorate, at their EPTDS sampling locations and at one distribution system sampling point per treatment plant (i.e., at the DSMRT ). Pre

- Screen Testing systems will monitor two times during the three year monitoring period (2013 through 2015) at their EPTD S. Following publication of the proposed rule and EPA’ s initial cost and burden estimates, EPA received several cost

- related public comments. Several suggested that EPA ’ s estimates of cost and burden (e.g., laboratory and estimated labor burden) to PWSs were too low. EPA estimates of laboratory fees are based on consultations with commercial drinking water laboratories and a review of the costs of similar analytical methods. In response to comments, EPA revisited the analytical method cost estimates. EPA approached four commercial drinking water laboratories and reques ted pricing estimates for UCMR 3 methods, including the cost of field blanks for methods 524.3 (VOCs), 537 (PFCs), and 539 (hormones). EPA averaged the estimates from the four laboratories and updated the cost figures. With respect to per

- system burden estimates, EPA notes that all estimates represent

av erage burden hours, which include surface water systems that may have very few sampling points, and thus lower sampling burden, as well as those systems with higher number s of*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 52 of 108 sampling points that would have greater labor burden. Moreover, a system ’s burde n is primarily incurred during its one year of required UCMR monitoring (between January 2013 and December 2015). However, in compliance with the requirements of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.), these cost and burden estimates are pres ented as an average over the applicable three -year information collection request (ICR) period (2012 - 2014). Small systems (those serving 10,000 or fewer people) will have the lowest burden not only because they generally have fewer sampling locations , but also because these systems will receive substantial direct assistance from EPA and/or their State. The cost of the Assessment Monitoring analysis for the UCMR 3 chemicals is estimated at $1,50 3 per sample set (at the EPTDS) where contaminants are no t detected, and field blank samples for methods 524.3 (VOCs), 537 (PFCs), and 539 (hormones) do not have to be analyzed. The cost to analyze both a UCMR sample and a field blank sample (where contaminants are detected) for the three methods above is estimated at $2,300. The cost to EPA of the Pre -Screen analyses for viruses and related pathogen indicators (i.e., total coliform s, E. coli , bacteriophage, Enterococci , and aerobic spores) is estimated at $1,880 per sample set. Shipping estimates are added to th e calculated costs to der ive the total direct analytical non

- labor costs. Estimated shipping costs were based on the average cost of shipping a 25-pound package. In preparing the UCMR 3 ICR, EPA relied on standard assumptions and data sources used in the preparation of other drinking water program ICRs. These include the PWS inventory, number of sampling points per system, and labor rates. EPA expects that States will incur only labor costs associated with voluntary assistance with UCMR 3 implementation. St ate costs were estimated using the relevant modules of the State Resource Model that was developed by the*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 53 of 108 Association of State Drinking Water Administrators (ASDWA) in conjunction with EPA (ASDWA, 2003) to help States forecast resource needs. Model estimat es were adjusted to account for actual levels of State participation under UCMR. Because State participation is voluntary, level of effort will vary across States and depend on their individual agreements with
EPA. Over the UCMR implementation period of 2012-2016, EPA estimates that nationwide, the average annual cost of UCMR 3 is approximately $ 19.8 million . These total estimated annual costs (labor and non- labor) are incurred as follows:

Respondent Avg. Annual Cost. All Respondents (2012
- 16) Small Systems (25

- 10,000), including labor only, non

- labor costs paid for by EPA $0.05 2 m Large Systems (10,001

- 100,000), including labor and non

- labor costs $11. 8 m Very Large Systems (100,001 and greater), including labor and non

- labor costs $2.9 m States, including labor costs related to implementation coordination $0.75 m EPA, including labor for implementation, non

- labor for small system testing $4. 2 m AVERAGE ANNUAL NATIONAL TOTAL 1 $ 19. 8 m 1. Average Annual National Total of $19.8 million is based on rounding.

Additional details regarding EPA’s cost assumptions and estimates can be found in the
ICR amendment prepared for this final rule (Office of Management and Budget (OMB) number 2040-NEW), which presents estimated cost and burden for the 2012-2014 period. Estimates of costs over the entire five

- year UCMR 3 period of 2012

- 2016 are attached as an appendix to the ICR. Copies of the ICR and its amendment may be obtained from the EPA public docket for this
fin al rule under Docket ID Number EPA- HQ

- OW -2009-0090.*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 54 of 108 VI. Statutory and Executive Order Reviews A. Executive Order 12866: Regulatory Planning and Review and Executive Order 13563: Improving Regulation and Regulatory Review Under Executive Order 12866 (58 FR 51735, October 4, 1993), this action is a

“ significant regulatory action. ” Accordingly, EPA submitted this action to the Office of Management and Budget (OMB) for review under Executive Orders 12866 and 13563 (76 FR 3821, January 21, 2011) and any changes made in response to OMB recommendations have been documented in the docket for this action. In addition, EPA prepared an analysis of the potential costs and benefits associated with this action. This analysis is contained in the “ Information Collect ion Request for the Unregulated Contaminant Monitoring Regulation ( UCMR 3)” . A copy of the analysis is available in the docket for this action and the analysis is briefly summarized in Section V of the preamble of this final rule.

B. Paperwork Reduction Act The information collection requirements in this rule have been submitted for approval to the Office of Management and Budget (OMB) under the Paperwork Reduction Act , 44 U.S.C. 3501 et seq . The information collection requirements are not enforceable until OMB approves them. The information collected under this final rule fulfills the statutory requirements of Section 1445(a)(2) of SDWA, as amended in 1996. The data collected will describe the source of the water, location, and test results for samples taken from PWSs. The concentrations of any identified UCMR contaminants will be evaluated in conjunction with health effects information*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 55 of 108 and will be considered for future regulation accordingly. Reporting is mandatory. The data are not subject to confidentiality protection. The annual burden and cost estimates described in this section are for the implementation assumptions described in Section V. Cost and Benefits of the Rule. Respondents to the UCMR 3 will include 1,600 small water systems (800 for Assessment Monitoring, and 800 for Pre- Screen Testing), the 4,215 large PWSs, and the 56 States and Primacy agencies ( 5,871 total respondents). The frequency of response varies across respondents and years. S ystem costs (particularly laboratory analytical costs) vary depending on the number of sampling locations. For cost estimat es, it is assumed that systems will conduct sampling evenly across January 2013 through December 2015 (i.e., one- third of systems in each of the 3 consecutive 12-month periods). Because the applicable ICR period is 2012-2014, the third year of monitoring activity (i.e., January through December of 2015) is not captured in the current ICR estimates. The burden and cost estimates presented in this section represent average costs. In some cases, the costs are presented as an annual average. Average burden or cost per system was derived by calculating total costs, and dividing by the total number of systems expected to monitor during the ICR years of 2012-2014. Average annual burden or cost per system was derived by summing total costs (or burden), dividing by the number of systems expected to monitor during the ICR years of 2012-2014, and then dividing by three years. The total costs and the annual average costs over the ICR years of 2012- 2014 are presented in Exhibit 7. Total and annual average costs for the entire 5 -year UCMR 3 period can be found in the ICR for UCMR 3, available in the docket for this final rule. Small systems (those servi ng 10,000 or fewer) that are selected for UCMR 3 monitoring*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 56 of 108 will sample an average of 2.3 times per system (i.e., number of responses per system) across the three -year ICR period of 2012-2014. The average burden per response for small systems is estimated to be 3.1 hours. Large systems (those serving 10,001 to 100,000 people) and very large systems (those serving more than 100,000 people) will sample and report an average of 2.7 and 3.7 times per system, respectively, across the three-year ICR period of 2012-2014. The average burden per response for large and very large systems is estimated to be 9.1 and 9.4 hours, respectively. States are assumed to have an average of 1.0 response per year (3.0 responses per State across the three -year ICR period of 2012-2014), related to coordination with EPA and systems, with an average burden per response of 233 hours. In aggregate, during the ICR period of 2012-2014, the average response (e.g., responses from systems and States) is associated with a burden of 11.3 hours, with a labor plus non-labor cost of $4,984 per response. Exhibit 7 presents respondent burden and cost estimates for the ICR period of 2012-2014.

Exhibit 7 : UCMR 3 Per Respondent Burden and Cost Summary for the ICR Period (2012-2014) Burden (hours)/

Cost (dollars) Small Systems Large Systems Very Large Systems States National Average Three
- Year Total Per Respondent Total # of Responses Per Respondent (hr) 2.3 2.7 3.7 3.0 2.7 Labor Cost Per Respondent $162 $767 $1,327 $41,975 $1,229 Non

- Labor Cost Per Respondent $0 $14,756 $34,181 $0 $11,904 Total Cost (Labor plus Non

- Labor) $162 $15,524 $35,508 $41,975 $13,133 Total Cost Per Response $69 $5,781 $9,673 $13,992 $4,927 Total Burden Per Respondent (hr) 7.0 24.6 34.6 700.1 30.1 Total Burden Per Response (hr) 3.0 9.1 9.4 233.4 11.3 Average Annual Per Respondent Ave. # of Responses Per Respondent (hr) 0.8 0.9 1.2 1.0 0.9 Labor Cost Per Respondent $54 $256 $442 $13,992 $410 Non

- Labor Cost Per Respondent $0 $4,919 $11,394 $0 $3,968*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 57 of 108 Exhibit 7 : UCMR 3 Per Respondent Burden and Cost Summary for the ICR Period (2012-2014) Burden (hours)/

Cost (dollars) Small Systems Large Systems Very Large Systems States National Average Ave. Cost (Labor plus Non

- Labor) $54 $5,175 $11,836 $13,992 $4,378 Ave. Cost Per Response $23 $1,927 $3,224 $4,664 $1,642 Ave. Burden Per Respondent (hr) 2.3 8.2 11.6 233.4 10 Ave. Burden Per Response (hr) 1.0 3.0 3.1 61.3 3.8
The average per respondent burden hours and costs per year for the ICR period of 2012- 2014 are: small systems – 2.3 hour burden at $54 for labor; large systems – 8.2 hours at $256 for labor, and $4,919 for analytical costs; very large systems – 11.6 hours at $442 for labor, and $11,394 for analytical costs; and States – 233.4 hours at $13,992 for labor. Burden is defined at 5 CFR 1320.3(b). An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. The OMB control numbers for EPA’s regulations in 40 CFR are listed in 40 CFR part 9. When this ICR is approved by OMB, the Agency will publish a technical amendment to 40 CFR part 9 in the Federal Register to display the OMB control number for the approved information collection requirements contained in this final rule.

C. Regulatory Flexibility Act The Regulatory Flexibility Act (RFA) generally requires an agency to prepare a regulatory flexibility analysis of any rule subject to notice and comment rulemaking requirements under the Administrative Procedure Act or any other statute unless the agency certifies that the rule will not have a significant economic impact on a substantial number of*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 58 of 108 small entities. Small entities include small businesses, small organizations, and small governmental jurisdictions. The RFA provides default definitions for each type of small entity. Small entities are defined as: (1) a small business as defined by the Small Business Administration ’ s (SBA) regulations at 13 CFR 121.201; (2) a small governmental jurisdiction that is a government of a city, county, town, school district or special district with a population of less than 50,000; and (3) a small organization that is any “not- for -profit enterprise which is independently owned and operated and is not dominant in its field.” However, the RFA also authorizes an agency to use alternative definitions for each category of small entity, “ which are appropriate to the activities of the agency ” after proposing the alternative definition(s) in the Federal Register and taking comment (5 U.S.C. 601(3) - (5)). In addition, to establish an alternative small business definition, agencies must consult with SBA’s Chief Counsel for Advocacy. For purposes of assessing the impacts of this rule on small entities, EPA considered small entities to be PWSs serving 10,000 or fewer people, because this is the system size specified in SDWA as requiring special consideration with respect to small system flexibility. As required by the RFA, EPA proposed using this alternative def inition in the Federal Register (63 FR 7606, February 13, 1998 (USEPA, 1998a)), requested public comment, consulted with the SBA, and finalized the alternative definition in the Co nsumer Confidence Reports rulemaking (63 FR 44512, August 19, 1998 (USEPA, 1998b)). As stated in that Final Rule, the alternative definition will be applied to future drinking water regulations, including this regulation. After considering the economic impacts of this rule on small entities, I certify that this action will not have a significant economic impact on a substantial number of small entities. The*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 59 of 108 small entities directly regulated by this rule are PWSs serving 10,000 or fewer people. EPA has deter mined that the small entities subject to the requirements of this rule are a subset of the small PWSs (those serving 10,000 or fewer people). The Agency has determined that 1,600 small PWSs (across Assessment Monitoring and Pre-Screen Testing), or approxim ately 3% of small systems, will experience an impact of no more than 0.4% of revenues; the remainder of small systems will not be impacted. Although this final rule will not have a significant economic impact on a substantial number of small entities, EPA has tried to reduce the impact of this rule on small entities. To ensure that this rule will not have a significant economic impact on a substantial number of small entities, EPA will assume all costs for analyses of the samples and for shipping the sample s from these systems to the laboratories contracted by EPA to analyze UCMR 3 samples. EPA has set aside $2.0 million each year from the State Revolving Fund (SRF) with its authority to use SRF monies for the purposes of implementing this provision of SDWA. Thus, the costs to these small systems will be limited to the labor hours associated with 800 small systems collecting a n Assessment Monitoring sample and preparing it for shipping. The evaluation of the overall impact on small systems, summarized in the preceding discussion, is further described as follows. EPA analyzed the impacts for privately- owned and publicly- owned water systems separately due to the different economic characteristics of these ownership types, such as different rate structures and pr ofit goals. For both publicly- and privately -owned systems, EPA used the “ revenue test, ” which compares annual system costs attributed to the rule to the system ’s annual revenues. Median revenue data from the 2006 Community Water System Survey Volume II: D etailed Tables and Survey Methodology*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 60 of 108 ( http://water.epa.gov/aboutow/ogwdw/upload/cwssreportvolumeII2006.pdf ) were used for public and private water systems. EPA assumes that the distribution of the sample of participating small systems will reflect the proportions of publicly - and privately-owned systems in the national inventory. The estimated distribution of the representative sample, categorized by ownership type, source water, and system size, is presented in Exhibit 8.

Exhibit 8 : Number of Publicly - and Privately- Owned Small Systems Subject to UCMR 3 System Size (# of people served) Publicly- Owned Privately

- Owned Total
Ground Water 500 and under 121 364 485 501 to 3,300 451 172 623 3,301 to 10,000 179 41 220 Subtotal GW 751 577 1,328 Surface Water (and GWUDI) 500 and under 5 5 10 501 to 3,300 61 22 83 3,301 to 10,000 139 40 179 Subtotal SW 205 67 272 Total of Small Water Systems 956 644 1,600

The basis for the UCMR 3 RFA certification for this final rule is as follows: for the 1,600 small water systems that will be affected, the average annual costs for complying with this rule represent 0.4% of system revenues (the highest estimated percentage is for ground water systems serving 500 or fewer people, at 0.41% of its median revenue). Exhibit 9 presents th e yearly costs*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 61 of 108 to small systems and to EPA for the small system sampling program, along with an illustration of system participation for each ye ar of the UCMR 3 program.

Exhibit 9: EPA and Systems Costs for Implementation of UCMR 3 at Small Systems Cost Description 2012 2013 2014 2015 2016 Total Costs to EPA for Small System Program (including Assessment Monitoring, and Pre- Screen Testing) $0 $5,550,429 $5,550,429 $5,550,429 $0 $16,651,288 Costs to Small Systems (including Assessment Monitoring, and Pre- Screen Testing): $0 $86,405 $86,405 $86,405 $0 $259,214 Total Costs to EPA and Small Systems for UCMR 3: $0 $5,636,834 $5,636,834 $5,636,834 $0 $16,910,502 System Monitoring Activity Timeline: 1

Assessment Monitoring 1/3 PWSs Sample 1/3 PWSs Sample 1/3 PWSs Sample 800 Pre

- Screen

Testing 1/3 PWSs Sample 1/3 PWSs Sample 1/3 PWSs Sample 800 1 Total number of systems is 1,600. No small system conducts more than one type of monitoring study.

System costs are attributed to the labor required for reading about their requirements, training staff on requirements, monitoring, including travel time needed to collect samples, reporting, and record keeping. The estimated average annual burden across the five- year UCMR 3 implementation period of 2012-2016 is estimated to be 1.4 hours at $32 per small system. Average annual cost, in all cases, is less than or equal to 0.41% of system revenues. As required by SDWA, the Agency specifically structured the r ule to avoid significantly affecting*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 62 of 108 small entities by assuming all costs for laboratory analyses, shipping, and quality control for small entities. As a result, EPA incurs the entirety of the non

- labor costs associated with
UCMR 3 small system monitoring, or 99 % of total small system testing costs. Exhibits 10 and 11 present the estimated economic impacts in the form of a revenue test for publicly - and privately

owned systems.

Exhibit 10 : UCMR 3 Relative Cost Analysis for Small Publicly
- Owned Systems (2012-2016)
System Size (# of people served) Annual Number of

Systems Impacted Average Annual Hours

per System (2012-2016) Average Annual Cost per System (2012-2016) Revenue Test 1

Ground Water Systems 500 and under 24 1.2 $24.32 0.08% 501 to 3,300 90 1.3 $27.98 0.02% 3,301 to 10,000 36 1.7 $43.71 0.01% Surface Water (and GWUDI) Systems 500 and under 1 1.8 $38.06 0.07% 501 to 3,300 12 1.9 $41.99 0.02% 3,301 to 10,000 28 2.0 $51.02 0.005% 1 The “ Revenue Test ” was used to evaluate the economic impact of an information collection on small government entities (e.g., publicly

- owned systems); costs are presented as a percentage of median annual revenue in each size category.

Exhibit 11 : UCMR 3 Relative Cost Analys is for Small Privately -Owned Systems (2012-2016) System Size (# of people served) Annual Number of

Systems Impacted Average Annual Hours

per System (2012
- 2016) Average Annual Cost per System (2012
- 2016) Revenue Test 1*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 63 of 108 Ground Water Systems 500 and under 73 1.2 $24.32 0.41% 501 to 3,300 34 1.3 $27.98 0.03% 3,301 to 10,000 8 1.7 $43.71 0.004% Surface Water (and GWUDI) Systems 500 and under 1 1.8 $38.06 0.11% 501 to 3,300 4 1.9 $41.99 0.02% 3,301 to 10,000 8 2.0 $51.02 0.005% 1 The “ Revenue Test ” was used to evaluate the economic impact of an information collection on small private entities (e.g., privately

- owned systems); costs are presented as a percentage of median annual revenue in each size category.

EPA specifically solicited additional com ment on the proposed action on small systems. No comments were received.

D. Unfunded Mandates Reform Act (UMRA) This rule does not contain a Federal mandate that may result in expenditures of $100 million or more for State, local, and tribal governments, in the aggregate, or the private sector in any one year. Total annual costs of this final rule (across the implementation period of 2012– 2016), for State, local, and Tribal governments and the private sector, are estimated to be $19.8 million, of which EPA will pay $4.2 million, or approximately 21%. Thus, this rule is not subject to the requirements of Sections 202 or 205 of UMRA. This rule is also not subject to the requirements of Section 203 of UMRA because it contains no regulatory requirements that might significantly or uniquely affect small governments. As noted previously, the Agency expects to pay for the reasonable costs of sample*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 64 of 108 analysis for the small PWSs required to monitor for unregulated contaminants under this final rule, including those owned and operated by small governments. The only costs that small systems will incur are those attributed to collecting the UCMR sa mples and packing them for shipment to the laboratory (EPA will pay for shipping). These costs are minimal. They are not signific ant or unique. Thus, this rule is not subject to the requirements of UMRA Section 203.

E. Executive Order 13132: Federalism This action does not have federalism implications. It will not have substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132. The cost to State and local governments is minimal and the rule does not preempt State law. Thus, Executive Order 13132 does not apply to this action. In the spirit of Executive Order 13132, and consistent with EPA policy to promote communications between EPA and State and local governments, EPA specifically solicited comment on the proposed action from State and local officials.

F. Executive Order 13175 : Consultation and Coordination with Indian Tr ibal Governments Subject to the Executive Order 13175 (65 FR 67249, November 9, 2000) EPA may not issue a regulation that has tribal implications, that imposes substantial direct compliance costs, and that is not required by statute, unless the Federal government provides the funds necessary to pay the direct compliance costs incurred by tribal governments, or EPA consults with tribal officials early in the process of developing the proposed regulation and develops a tribal*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 65 of 108 summary impact statement. EPA has concluded that this action will have tribal implications. However, it will neither impose substantial direct compliance costs on tribal governments, nor preempt Tribal law. As described previously, this final rule requires monitoring by all large systems (i.e., those serving more than 10,000 people); 17 Tribal water systems have been identified as large systems based on information in the SDWIS/Fed water system inventory. EPA estimates the average annual cost to each of these large systems, over the five -year rule period, to be less than $3,105. This cost is based on a labor component (associated with the collection of samples) and a non-labor component (associated with shipping and laboratory fees) and represents less than 0.11 % of average revenue/sales fo r large systems. UCMR also requires monitoring by a nationally representative sample of small systems ( i.e., those serving 10,000 or fewer people). EPA estimates that approximately one percent of small Tribal systems will be selected as a nationally representative sample for Assessment Monitoring. EPA estimates the average annual cost to the small Tribal systems, over the five year rule period to be $32. Such cost is based on the labor associated with collecting a sample and preparing it for shipping and represents 0.4% or less of average revenue/sales for small systems. All other small

- system expenses (associated with shipping and laboratory fees) are paid by EPA. EPA consulted with tribal officials early in the process of developing UCMR to permit them to have meaningful and timely input into its development. In developing the original UCMR rule, EPA held stakeholder meetings and prepared background information for stakeholder review. EPA sent requests for review of stakeholder documents to nearly 400 Tribe s, Tribal organizations, and small systems organizations to obtain their input. Representatives from*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 66 of 108 the Indian Health Service (IHS) Sanitary Deficiency System and Tribes were consulted regarding decisions on rule design, the design for the statistical sel ection of small systems, and potential costs. Tribes raised issues concerning the selection of the nationally representative sample of small systems, particularly the manner in which Tribal systems would be considered under the sample selection process. EPA developed the sample frame for Tribal systems and Alaska Native water systems in response to those concerns. EPA worked with the Tribes, Alaska Natives, the IHS, and the States to determine how to classify each Tribal system for consideration in the
stat istically

- based selection of the nationally representative sample of small systems. As a result of those discussions, small PWSs located in Indian country in each of the EPA Regions containing Indian country were evaluated as part of a Tribal category that receives selection consideration comparable to that of small systems outside of Indian country. Thus, Tribal systems have the same probability of being selected as other water systems in the stratified selection process that weighs systems by water source and size class by population served. This final rule maintains the basic program design of UCMR 1 and 2, and continues to build upon the structure of this cyclical program. As part of the development of this rule, EPA held a public stakeholder meeting on April 7, 2010. This meeting was announced to the public in a Federal Register notice dated Februar y 23, 2010 (75 FR 8063 (USEPA, 2010a)). Prior to the meeting, background materials and rule development information were sent to specific stakeholders, including representatives from the IHS and the Native American Water Association. EPA specifically solic ited additional comment on the proposed action from tribal officials. EPA received n o comments.*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 67 of 108 G. Executive Order 13045: Protection of Children from Environmental Health Risks and Safety Risks EPA interprets EO 13045 (62 FR 19885, April 23, 1997) as applying only to those regulatory actions that concern health or safety risks, such that the analysis required under Section 5 -501 of the EO has the potential to influence the regulation. This action is not subject to EO 13045 because it does not establish an env ironmental standard intended to mitigate health or safety risks and it is not an economically significant regulation pursuant to EO 12866.

H. Executive Order 13211: Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use This action is not a “ significant energy action ” as defined in Executive Order 13211 (66 FR 28355 (May 22, 2001)), because it is not likely to have a significant adverse effect on the supply, distribution, or use of energy. None of the final UCMR requirements involve actions that use a measurable amount of energy.

I. National Technology Transfer and Advancement Act Section 12(d) of the National Technology Transfer and Advancement Act of 1995 (“ NTTAA ”), Public Law No. 104-113, 12(d) (15 U.S.C. 272 note) directs EPA to use voluntary consensus standards in its regulatory activities unless to do so would be inconsistent with applicable law or otherwise impractical. Voluntary consensus standards are technical standards (e.g., materials specifications, test methods , sampling procedures, and business practices) that are developed or adopted by voluntary consensus standards bodies. NTTAA directs EPA to provide Congress, through OMB, explanations when the Agency decides not to use available and*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 68 of 108 applicable voluntary consensus standards. This rulemaking involves technical standards. EPA has decided to use the methods developed by the Agency as well as voluntary consensus standards for the analysis of UCMR 3 contaminants. The Agency conducted a search of potentially applicable voluntary consensus standards and identified two major organizations whose methods are acceptable for determinations under UCM R . These organizations are Standard Methods ( SM ) and ASTM International . For many of the parameters included in this final action, EPA was unable to identify methods from voluntary consensus method organizations that were appropriate for the monitoring required. However, EPA identified acceptable consensus method organization standards for the analysis of total chromium, vanadium, molybdenum, cobalt, strontium and chlorate. Therefore, EPA is approving analytical methods published by EPA, SM, and ASTM International for these analytes.

J. Executive Order 12898: Federal Actions to Address Environmental Justice in Minority Populations and Low- Income Populations. Executive Order (EO) 12898 (59 FR 7629 (Feb. 16, 1994)) establishes federal executive policy on environmental justice. Its main provision directs federal agencies , to the greatest extent practicable and permitted by law, to make environmental justice part of their mission by identifying and addressing, as appropriate, disproportionately high and adverse human health orenvironmental effects of their programs, policies, and activities on minority populations and lowincome populations in the United States. EPA has determined that this final rule will not have disproportionately high and adverse human health or environmental effects on minority or low-income populatio ns because it*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 69 of 108 increases the level of environmental protection for all affected populations without having any disproportionately high and adverse human health or environmental effects on any population, including any minority or low-income population. By seeking to identify unregulated contaminants that may pose health risks via drinking water from all PWSs, UCMR furthers the protection of public health for all citizens, including minority and low-income populations using public water supplies. UCMR uses a statistically -derived set of systems for the nationally representative sample that is population

- weighted within each system size and source water category so that any PWS within a category has an equivalent likelihood of selection. Additionally, EPA is re quiring that PWSs report all U.S. Postal Service Zip Codes in their service area. This additional data element will be used in the evaluation of UCMR 3 occurrence data and could potentially identify areas that have disproportionately high and adverse human health or environmental effects on minority or low-income populations.

K. Congressional Review Act The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. EPA will submit a report containing this rule and oth er required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of the rule in the Federal Register. A Major rule cannot take effect until 60 days after it is published in the Federal Register. This action is not a “ major rule ” as defined by 5 U.S.C.*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 70 of 108 804(2). This rule will be effective [ INSERT DATE 30 DAYS AFTER PUBLICATION IN THE
FEDERAL REGISTER ].

VII. Public I nvolvement in Regulation D evelopment EPA ’s Office of Ground Water and Drinking Water routinely engages stakeholder s in its regulatory activities for the purpose of providing early input to regulation development. When designing and developing the UCMR program in the late 1990s, EPA held meetings for developing the CCL, establishing the information requirements of the NCOD, and selecting priority contaminants for UCMR monitoring. During the initial development of the UCMR program, stakeholders including PWSs, States, industry, and other organizations attended meetings to discuss the UCMR. Seventeen other meetings were held specifically concerning UCMR development. For a description of public involvement activities related to the first
UCMR ( UCMR 1) , please see the discussion in the September 17, 1999 UCMR Final Rule Federal Register at 64 FR 50556 (USEPA, 1999b ). Specific to the development of UCMR 3, a stakeholder meeting was held on April 7, 2010, in Washington, DC. There were 22 attendees, representing State agencies, laboratories, PWSs, environmental groups, and drinking water associations. The topics of presentations and discussions included: status of UCMR 2; rationale for developing the new list of potential contaminants; analytical methods that could be used in measuring these contaminants; sa mpling design; procedure for determining LCMRLs; laboratory approval; and other potential revisions based on lessons learned during implementation of UCMR 1 and UCMR 2 (see USEPA, 2010b for presentation materials, and USEPA, 2010c for meeting notes).*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 71 of 108 EPA requested public comment on the proposed rule (76 FR 11713, March 3, 2011 (USEPA, 2011a)), and established a public docket, under Docket ID No. EPA

- HQ

- OW -2009- 0090. Each set of comments received in response to this r equest was assigned an EPA Document ID ( EPA

- HQ

- OW -2009-0090+unique four digit extension) and posted for public access on regulations.gov. To view comments, search for the docket ID on the regulations.gov homepage, then click the link to public submissions. EPA received feedback on UCMR 3 from 53 commenter s. Commenters included: private citizen s; local and State governments as well as U.S. territories; industry and industry groups; drinking water systems and organizations; and, non-governmental organizations, such as environmental and health advoc acy groups . An overview of key comments received is included in Section III of this rule, and the complete report of comments and full EPA responses can be found in the docket on regulations. gov (USEPA, 2012b).

VIII. References Ando, T., S.S. Monroe, J.R. Gentsch, Q. Jin, D.C. Lewis, and R.I. Glass. 1995. Detection and differentiation of antigenically distinct small round -structured viruses (Norwalk- like viruses) by reverse transcription -PCR and southern hybridization. Journal of Clinical Microbiology. 33(1):64-71. Association of State Drinking Water Administrators (ASDWA). 2003. Public Health Protection Threatened by Inadequate Resources for State Drinking Water Programs–An Analysis of State Drinking Water Programs Resources, Needs, and Barriers. April 2003.
AST M D5673-10. 2010. Standard Test Method for Elements in Water by Inductively Coupled*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

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- Mass Spectrometry. Available for purchase on the Internet at http://www.astm.org/Standards/D5673.htm

. ASTM D6581-08. 2008. Standard Test Methods for Bromate, Bromide, Chlorate, and Chlorite in Drinking Water by Suppressed Ion Chromatography. Available for purchase on the
Internet at http://www.astm.org/ Standards/D6581.htm

. Bergmann, H. and S. Koparal. 2005. The formation of chlorine dioxide in the e lectrochemical
t reatment of drinking w ater for disinfection. Electrochimica Acta

. 50:5218-5228. Bolyard, M., P. S. Fair, and D.P. Hautman. 1992. Occurrence of chlorate in hypochlorite solutions used for drinking water disinfection. Environmental Science and Technology. 26(8):1663-1665. Bolyard, M., P. S. Fair, and D.P. Hautman. 1993. Sources of chlorate ion in US drinking water. Journal of the American Water Works Association . 85(9):81-88. Borchardt, M.A. 2008. Wisconsin Water And Health Trial for Enteric Risks (WAHTER Study) - Part 1:Risk of Illness from Municipal Groundwater Consumption. EPA Office of Water Symposium on Groundwater- Borne Infectious Disease, Etio logic Agents and Indicators, Washington, DC, December 2-4, 2008. Czarnetzki, L.R. and J.J. Janssen. 1992. Formation of hypochlorite, chlorate, and oxygen during NaCl e lectrolysis from a lkaline solutions at an RuO 2 /TiO 2 anode. Journal of Applied Electrochemistry . 22:315-324. De Leon, R., C. Shieh, R.S. Baric, and M.D. Sobsey. 1990. Detection of enteroviruses and hepatitis A virus in environmental samples by gene probes and polymerase chain
reaction . P. 833-835. In Advances of Water Analysis and Treatment Proceedings 1989.*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 73 of 108 Water Quality Technology Conference, American Water Works Association, Denver, CO. American Water Works Association, San Diego, CA. Fairbridge, R.W. 1972. The Encyclopedia of Geochemistry and Environmental Sciences, IVA Volume. New York: Van Nostrand Reinhold Company. Friedman, M.J., A.S. Hill, S.H Reiber, R.L. Valentine, and G.V. Korshin. 2009. Assessment of Inorganics Accumulation in Drinking Water System Scales and Sediments . Published by
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. Gallagher, D.L, R.C Hoehn, and A.M. Dietrich. 1994. Sources, Occurrence, and Control of Chlorine Dioxide By-Product Residuals in Drinking Water . Published by AwwaRF and
AWWA. Gerke, T.L., K.G. Scheckel, and J.B. Maynard. 2010. Speciation and distribution of vanadium in drinking water iron pipe corrosion by-products. Science of the Total Environment

. 408(23):5845-5853. Gibbons, C.D., R.A. Rodriguez., L. Tallon, and M.D. Sobsey. 2010. Evaluation of positively charged alumina nanofibre cartridge filters for the primary concentration of noroviruses, adenoviruses and male- specific coliphages from seawater. Journal of Applied Microbiology. 109(2):635-641. Gordon, G., B. Slootmaekers, S. Tachiyashiki, and D.W. Wood III. 1990. Minimizing chlorite ion and chlorate ion in water treated with chlorine dioxide. Journal of the American Water Works Association . 82(4):160-165. Gordon, G. and S. Tachiyashiki. 1991. Kinetics and mechanism of formation of chlorate ion from the hypochlorous acid/chlorite ion reaction at pH 6-10. Environmental Science and*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 74 of 108 Technology. 25(3):468-474. Gordon, G., L.C. Adam, B.P. Bubnis, B. Hoyt, A.J. Gillette, and A. Wilczak. 1993. Controllin g the formation of chlorate ion in liquid hypochlorite feedstocks. Journal of the American Water Works Association . 85(9):89-97. Gordon, G., L.C. Adam, and B.P. Bubnis. 1995. Minimizing Chlorate Ion Formation in Drinking Water When Hypochlorite Ion is the Chlorinating Agent . Published by AwwaRF and
AWWA. Gordon, G., L.C. Adam, B.P. Bubnis, C. Kuo, R.S. Cushing, and R.H. Sakaji. 1997. Predicting liquid bleach decomposition. Journal of the American Water Works Association. 89(4):142-149.Howard, K.L. and G.L. Boyer. 2007. Quantitative analysis of cyanobacterial toxins by matrixassisted laser desorption ionization mass spectrometry. Analytical Chemistry

. 79(15):5980-5986. Hunt, R.J., M.A. Borchardt, K.D. Richards, and S.K. Spencer. 2010. A ssessment of sewer source contamination of drinking water wells using tracers and human enteric viruses. Environmental Science and Technology. 44(20):7956-7963. Jothikumar, N., J.A. Lowther, K. Henshilwood, D.N. Lees, V.R. Hill, and J. Vinje ́. 2005. Rapid and sensitive detection of noroviruses by using TaqMan-based one- step reverse transcription -PCR assays and application to naturally contaminated shellfish samples. Applied and Environmental Microbiology. 71(4):1870-1875. Karim, M.R., E.R. Rhodes, N. Brinkman, L. Wymer, and G.S. Fout. 2009. New electropositive filter for concentrating enteroviruses and noroviruses from large volumes of water.*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 75 of 108 Applied and Environmental Microbiology. 75(8):2393–2399. Kolodziej, E.P., T. Harter, and D.L. Sedlak. 2004. Dairy wastewater, aquaculture, and spawning fish as sources of steroid hormones in the aquatic environment. Environmental Science and Technology . 38:6377-6384. Kolodziej, E.P. and D.L. Sedlak. 2007. Rangeland grazing as a source of steroid hormones to surface waters. Environmental Science and Technology . 41:3514-3520. Kolpin, D.W., E.T. Furlong, M.T. Meyer, E.M. Thurman, S.D. Zaugg, L.B. Barber, and H.T. Buxton. 2002. Pharmaceuticals, hormones, and other organic wastewater contaminants in U.S. streams, 1999-2000 : A national reconnaissance. Environmental Science and Technology . 36:1202-1211. Lambertini, E., S.K. Spencer, P.D. Bertz, F.J. Loge, B.A. Kieke, and M.A. Borchardt. 2008. Concentration of enteroviruses, adenoviruses, and noroviruses from drinking water by use of glass wool filters. Applied and Environmental Microbiology. 74(10):2990-2996. Mash, H., K. Schenck, and L. Rosenblum. 2010. Hypochlorite oxidation of select androgenic steroids. Water Research . 44:1950-1960. Monpoeho, S., A. Dehée, B. Mignotte, L. Schwartzbrod, V. Marechal, J.C. Nicolas, S. Billaudel, and V. Ferré. 2000. Quantification of enterovirus RNA in sludge samples by single tube real

- time RT

- PCR. BioTechniques. 29:88-95. Oehrle, S.A., B. Southwell, and J. Westrick. 2010. Detection of various freshwater cyanobacterial toxins using ultra-performance liquid chromatography tandem mass spectrometry. Toxicon . 55:965-972. Rice, R.G. and M. Gomez- Tayl or. 1986. Occurrence of by-products of strong oxidants reacting*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 76 of 108 with drinking water contaminants-scope of the problem. Environmental Health Perspectives . 69:31-44. Siddiqui, M.S. 1996. Chlorine-ozone interactions: Formation of chlorate. Water Research

. 30(8):2160-2170. Snyder, S.A., B.D. Stanford, A.N. Pisarenko, G. Gordon, and M. Asami. 2009. Hypochlorite – An Assessment of Factors that Influence the Formation of Perchlorate and Other
Contaminants . Jointly funded by AWWA and WRF. Available on the Internet at http://www.awwa.org/files/GovtPublicAffairs/PDF/HypochloriteAssess.pdf

. SM 3125. 2005. Metals by Inductively Coupled Plasma/Mass Spectrometry

. Standard Methods for the Examination of Water and Wastewater , 21 st edition. American Public Health Association, 800 I Street, NW, Washington, DC 20001-3710. SM 4110D. 2005. Determination of Anions by Ion Chromatography, Part D, IC Determination of Oxyhalides and Bromide. Standard Methods for the Examination of Water and
Wastewater , 21 st edition. American Public Health Association, 800 I Street, NW, Washington, DC 20001-3710. Stanford, B.D., A.B. Pisarenko, S.A. Snyder, and G. Gordon. 2011. Perchlorate, bromate, and chlorate in hy pochlorite solutions: Guidelines for utilities. Journal of the American Water Works Association . 103(6):71-83. USEPA. 1994. Method 200.8 - Determination of Trace Elements in Waters and Wastes by Inductively Coupled Plasma-Mass Spectrometry. Revision 5.4. Available on the Internet
at https://www.nemi.gov/

. USEPA. 1995. Handbook for Preparing Office of Research and Development Reports , Third*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 77 of 108 Edition. EPA 600-K-95-002. August 1995. USEPA. 1996. National Primary Drinking Water Regulations: Monitoring Requirements for Public Drinking Water Supplies: Cryptosporidium, Giardia, Viruses, Disinfection Byproducts, Water Treatment Plant Data and Other Information Requirements. Federal Registe r. Vol. 61, No. 94, p. 24353, May 14, 1996. USEPA. 1997. Method 300.1 - Determination of Inorganic Anions in Drinking Water by Ion Chromatography. Revision 1.0. Available on the Internet at http://water.epa.gov/scitech/drinkingwater/labcert/analyticalmethods_ogwdw.cfm

. USEPA. 1998a. 40 CFR Parts 141 and 142 National Primary Drinking Water Regulations: Consumer Confidence; Proposed Rule. Federal Register . Vol. 63, No. 30, p. 7606, February 13, 1998. USEPA. 1998b. 40 CFR Parts 141 and 142 National Primary Drinking Water Regulation: Consumer Confidence Reports; Final Rule. Federal Register . Vol. 63, No. 160, p. 44512, August 19, 1998.
USEPA. 1999a. Alternative Disinfectants and Oxidants Guidance Manual . Office of Water. EPA 815-R-99-014. April 1999. Available on the Internet at http://water.epa.gov/lawsregs/rulesregs/sdwa/mdbp/mdbptg.cfm

. USEPA. 1999b. Revisions to the Unregulated Contaminant Monitoring Regulation for Public Water Systems; Final Rule. Federal Register. Vol. 64, No. 180, p. 50556, September 17, 1999.
USEPA. 2001. Statistical Design and Sample Selection for the Unregulated Contaminant Monitoring Regulation (1999). EPA 815-R-01-004. August 2001.*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 78 of 108 USEPA. 2003. National Primary Drinking Water Regulations: Stage 2 Disinfectants and Disinfection Byproducts Rule; National Primary and Secondary Drinking Water Regulations: Approval of Analytical Methods for Chemical Contaminants. Federal Register. Vol. 68, No. 159, p. 49547, August 18, 2003.
USEPA. 2006. U.S. Environmental Protection Agency Peer Review Handbook, Third Edition. EPA 100-B-06-002. Available on the Internet at http://www.epa.gov/peerreview/pdfs/peer_review_handbook_2006.pdf

. USEPA. 2007. Unregulated Contaminant Monitoring Regulation (UCMR) for Public Water Systems Revisions. Federal Register . Vol. 72, No. 2, p. 367, January 4, 2007.
USEPA. 2008. Method 522 - Determination of 1,4-Dioxane in Drinking Water by Solid Phase Extraction (SPE) and Gas Chromatography/Mass Spectrometry (GC/MS) with Selected Ion Monitoring (SIM). Version 1.0, September 2008. EPA 600-R-08-101. Available on the Internet at http://www.epa.gov/nerlcwww/ordmeth.htm

. USEPA. 2009a. Method 524.3 - Measurement of Purgeable Organic Compounds in Water by Capillary Column Gas Chromatography/Mass Spectrometry. Version 1.0, June 2009.
EPA 815-B-09-009. Available on the Internet at http://water.epa.gov/scitech/drinkingwater/labcert/analyticalmethods_ogwdw.cfm

. USEPA. 2009b. Method 537 - Determination of Selected Perfluorinated Alkyl Acids in Drinking Water by Solid Phase Extraction and Liquid Chromatography/Tandem Mass Spectrometry ( LC/MS/MS). Version 1.1, September 2009. EPA 600-R-08-092. Available on the Internet at http://www.epa.gov/nerlcwww/ordmeth.htm

. USEPA. 2010a. Stakeholder Meeting Regarding Revisions to the Unregulated Contaminant*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 79 of 108 Monitoring Regulation. Federal Register. Vol. 75, No. 35, p. 8063, February 23, 2010. USEPA. 2010b. Stakeholder Meeting Regarding Revisions to the Unregulated Contaminant Monitoring Regulation – Presentation Materials. April 7, 2010.
USEPA. 2010 c. Stakeholder Meeting Regarding Revisions to the Unregulated Contaminant Monitoring Regulation – Meeting Notes. April 2010. USEPA. 2010d. The Analysis of Regulated Contaminant Occurrence Data from Public Water Systems in Support of the Second Six- Year Rev iew of National Primary Drinking Water Regulations

. EPA 815-B-09-006. September 2010. Available on the Internet at http://water.epa.gov/lawsregs/rulesregs/regulatingcontaminants/sixyearreview/second_re view/upload/6Yr2OccurrenceReport_Revised_September2010.pdf

. USEPA. 2010e. Method 539 - Determination of Hormones in Drinking Water by Solid Phase Extraction (SPE) and Liquid Chromatography Electrospray Ionization Tandem Mass Spectrometry (LC

- ESI -MS/MS). Version 1.0, November 2010. EPA 815-B-10-001. Available on the Internet at http://water.epa.gov/scitech/drinkingwater/labcert/analyticalmethods_ogwdw.cfm

. USEPA. 2010f. Technical Basis for the Lowest Concentration Minimum Reporting Level (LCMRL) Calculator . EPA 815-R-11-001. December 2010.
USEPA . 2011a. Revisions to the Unregulated Contaminant Monitoring Regulation ( UCMR 3 ) for Public Water Systems; Proposed Rule. Federal Register

. Vol. 76, No. 42, p. 11713, March 3, 2011. USEPA. 2011b. EPA Method 218.7 - Determination of Dissolved Hexavalent Chromium in Drinking Water by Ion Chromatography. Version 1.0, November 2011 . EPA 600-R-11-*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 80 of 108 0XX

. Available on the Intern et at http://water.epa.gov/scitech/drinkingwater/labcert/analyticalmethods_ogwdw.cfm

. USEPA. 2012a. Memo to file: Summary of Lowest Concentration Minimum Reporting Level (LCMRL) Results for UCMR 3. January 2012. USEPA. 2012b. Response to Comments Document for the Unregulated Contaminant Monitoring Regulation (UCMR 3). EPA 815-R-11-004. January 2012.
USEPA. 2012c. UCMR 3 Contaminants – Information Compendium. EPA 815-B-11-001. January 2012. USEPA. 2012d. UCMR 3 Laboratory Approval Requirements and Information Document

. Version 2.0. EPA 815-R-11-003. January 2012. von Gunten, U. 2003. Ozonation of drinking water: Part II. Disinfection and by-product formation in presence of bromide, iodide or chlorine. Water Research . 37:1469-1487. World Health Organization (WHO). 2005. Chlorite and Chlorate in Drinking-water, Backg round Document for Development of WHO Guidelines for Drinking- water Quality , WHO/SDE/WSH/05.08/86.

List of Subjects

40 CFR Part 141 Environmental protection, Chemicals, Incorporation by reference, Indians-lands, Intergovernmental relations, Radiation protection, Reporting and record keeping requirements, Water supply.*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 81 of 108 [ Title: Revisions to the Unregulated Contaminant Monitoring Regulation ( UCMR 3 ) for Public Water Systems ; page 81 of 108]

40 CFR Part 142 Environmental protection, Administrative practices and procedures, Chemicals, Indian lands, Radiation protection, Reporting and recordkeeping requirements, Water supply.

Dated:

Lisa P. Jackson, Administrator.

For the reasons set out in the preamble, Title 40, chapter 1 of the Code of Federal Regulations is amended as follows:

PART 141 - NATIONAL PRIMARY DRINKING WATER REGULATIONS

1. The authority citation for Part 141 continues to read as follows:*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 82 of 108 Authority: 42 U.S.C. 300f, 300g-1, 300g-2, 300g-3, 300g-4, 300g-5, 300g-6, 300j-4, 300j-9, and 300j-11.

Subpart C

– Monitoring and Analytical Requirements

2. Section 141.23 is amended in the table to paragraph (k)(1) by revising entries 18, 19, and 20;

and by removing footnote 23. The revisions read as follows:

§141.23 Inorganic chemical sampling and analytical requirements.

* * * * * (k) Inorganic analysis:
* * * * *

Contaminant Methodology 13 EPA Method ASTM 3 SM 4 (18 th
, 19 th ed.) SM 4 (20 th ed.) SM Online 22 Other * * * * * * * 18. Nitrate Ion Chromatography 300.0 6 300.1 19 D4327

- 97, 03 4110 B 4110 B 4110 B

00 B

- 1011 8
Automated Cadmium Reduction 353.2 6 D3867

- 90 A 4500

- NO 3 - F 4500

- NO 3 - F 4500

- NO 3 - F00 Ion Selective Electrode ......................... .................. 4500

- NO 3 - D 4500

- NO 3 - D 4500

- NO 3 - D00 601 7

Manual Cadmium Reduction ......................... D3867

- 90 B 4500

- NO 3 - E 4500

- NO 3 - E 4500

- NO 3 - E00*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 83 of 108 Contaminant Methodology 13 EPA Method ASTM 3 SM 4 (18 th
, 19 th ed.) SM 4 (20 th ed.) SM Online 22 Other Capillary Ion Electrophoresis ......................... D6508

- 00.

................. ................. .............. 19. Nitrite Ion Chromatography 300.0 6 300.1 19 D4327

- 97, 03 4110 B.... 4110 B.... 4110 B

00 B

- 1011 8
Automated Cadmium Reduction 353.2 6 D3867

- 90 A 4500

- NO 3 - F 4500

- NO 3 - F 4500

- NO 3 - F00 Manual Cadmium Reduction ......................... D3867

- 90 B 4500

- NO 3 - E 4500

- NO 3 - E 4500

- NO 3 - E00 Spectrophotometric

......................... .................. 4500

- NO 2 - B 4500

- NO 2 - B 4500

- NO 2 - B00 Capillary Ion Electrophoresis ......................... D6508

- 00

................. ................. ............... 20. Ortho

phosphate Colorimetric, Automated, Ascorbic Acid 365.1 6

.................. 4500

- P F 4500

- P F

...............
Colorimetric, ascorbic acid, single reagent ......................... D515

- 88 A 4500

- P E 4500

- P E

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

Colorimetric Phosphomolybdate; Automated

segmented flow; Automated Discrete .........................

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

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

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

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

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

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

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

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

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

............... I

- 1601

- 85 5
I-2601- 90 5 I-2598- 85 5 Ion Chromatography 300.0 6 300.1 19 D4327

- 97, 03 4110 B 4110 B 4110 B

00 Capillary Ion Electrophoresis ......................... D6508

- 00

................. ................. ............... * * * * * * *

* * * * *

3 Annual Book of ASTM Standards , 1994, 1996, 1999, or 2003, Vols. 11.01 and 11.02, ASTM International; any year containing the cited version of the method may be used. The previous versions of D1688-95A, D1688-95C (copper), D3559-95D (lead), D1293-*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 84 of 108 95 (pH), D1125-91A (conductivity) and D859- 94 (silica) are also approved. These previous versions D1688-90A, C; D3559-90D, D1293-84, D1125-91A and D859-88, respectively are located in the Annual Book of ASTM Standards , 1994, Vol. 11.01. Copies may be obtained from ASTM International, 100 Barr Harbor Drive, West Conshohocken, PA 19428.

4 Standard Methods for the Examination of Water and Wastewater , 18 th edition (1992), 19 th edition (1995) or 20 th edition (1998). American Public Health Association, 800 I Street, NW, Washington, DC 20001-3710. The cited methods published in any of these three editions may be used, except that the versions of 3111 B, 3111 D, 3113 B and 3114 B in the 20 th edition may not be used.

5 Method I -2601-90, Methods for Analysis by the U.S. Geological Survey National Water Quality Laboratory – Determination of Inorganic and Organic Constituents in Water and Fluvial Sediment, Open File Report 93-125, 1993; For Meth ods I -1030- 85; I -1601- 85; I

1700- 85; I -2598- 85; I -2700-85; and I-3300- 85. See Techniques of Water Resources Investigation of the U.S. Geological Survey, Book 5, Chapter A-1, 3 rd edition, 1989; Available from Information Services, U.S. Geological Survey, Fe deral Center, Box 25286, Denver, CO 80225-0425.

6 “Methods for the Determination of Inorganic Substances in Environmental Samples,” EPA/600/R-93/100, August 1993. Available at NTIS, PB94-120821.*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 85 of 108 7 The procedure shall be done in accordance with the Techni cal Bulletin 601 “Standard Method of Test for Nitrate in Drinking Water,” July 1994, PN 221890- 001, Analytical Technology, Inc. Copies may be obtained from ATI Orion, 529 Main Street, Boston, MA 02129.

8 Method B-1011. “ Waters Test Method for Determination of Nitrite/Nitrate in Water Using Single Column Ion Chromatography,” August, 1987. Copies may be obtained from Waters Corporation, Technical Services Division, 34 Maple Street, Milford, MA 01757, Telephone: 508/482-2963, Fax: 508/482-4056.

* * * * *

13 Because MDLs reported in EPA Methods 200.7 and 200.9 were determined using a 2x preconcentration step during sample digestion, MDLs determined when samples are analyzed by direct analysis ( i.e. , no sample digestion) will be higher. For direct analysis of cadmium and arsenic by Method 200.7, and arsenic by Method 3120 B, sample preconcentration using pneumatic nebulization may be required to achieve lower detection limits. Preconcentration may also be required for direct analysis of antimony, lead, and thallium by Method 200.9; antimony and lead by Method 3113 B; and lead by Method D3559-90D, unless multiple in- furnace depositions are made.*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 86 of 108 * * * * *

19 “Methods for the Determination of Organic and Inorganic Compounds in Drinking Water, ” Vol. 1, EPA 815-R-00-014, August 2000. Available at NTIS, PB2000-106981.

* * * * *

22 Standard Methods Online are available at http://www.standardmethods.org . The year in which each method was approved by the Standard Methods C ommittee is designated by the last two digits in the method number. The methods listed are the only online versions that may be used.

3. Section 141.35 is amended as follows:

a. In paragraph ( a) by revising the third sentence, b. By revising paragraph (b) introductory text,

c. By revising paragraph (b)(1) , d. In paragraph (b)(2) by revising the first sentence,

e. By revising paragraph (c)(1) , f. By revising paragraph (c )( 2),
g. In paragraph (c)(3)(i) by remov ing “May 4, 2007” and add ing in its place, “June 1, 2012,” h. In paragraph (c) (3) ( ii ) by adding a new second and third sentence,*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 87 of 108 i. In paragraph (c)(4) by removing “June 4, 2007” and add ing in its place, “[ INSERT DATE 150 DAYS AFTER DATE OF PUBLICATION IN FEDERAL REGISTER ],” j. By revising paragraph (c)(5)(i ), k. By revising paragraph (c)(6) introductory text, l. By revising paragraph (c)(6)(ii) ,

m. By revising paragraph (d)(1), n. By revising paragraph ( d)(2) , and o. In the table to paragraph ( e) by revising entry 6.

The revisions and additions read as follows: §141.35 Reporting for unregulated contaminant monitoring results. (a) * * * For the purposes of this section, PWS “population served” is the retail population served directly by the PWS as reported to the Federal Safe Drinking Wate r Information System (SDWIS/Fed) ; wholesale or consecutive populations are not included. * * *

(b) Reporting by all systems . You must meet the reporting requirements of this paragraph if you meet the applicability criteria in §141.40 (a)(1) and (2).
* * * * *

(1) Where to submit UCMR reporting requirement information. Some of your reporting*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 88 of 108 requirements are to be fulfilled electronically and others by mail. Information that must be submitted using EPA’ s electronic data reporting system must be submitted th rough: http://water.epa.gov/lawsregs/rulesregs/sdwa/ucmr/ucmr3/reporting.cfm . Documentation that is required to be mailed can be submitted either: To UCMR Sampling Coordinator, USEPA, Technical Support Center, 26 West Martin Luther King Drive (MS 140), Cincinnati, OH 45268; or by email at UCMR_Sampling_Coordinator@epa.gov . In addition, you must notify the public of the availability of unregulated contaminant monitoring data as provided in Subpart Q (Public Notification) of this part (40 CFR 141.207). Community Water Systems that detect unregulated contaminants under this monitoring must also address such detections as part of their Consumer Confidence Reports, as provided in Subpart O of this part (40 CFR 141.151).
(2) * * * If you have received a letter from EPA concerning your required monitoring and your system does not meet the applicability criteria for UCMR established in §141.40(a)(1) or (2), or if a change occurs at yo ur system that may affect your requirements under UCMR as defined in §141.40(a)(3) through (5), you must mail or

e mail a letter to EPA, as specified in paragraph (b)(1) of this section. * * *
* * * * *

(c ) * * *
(1) Contact and zip code information. You must provide contact information by October 1, 2012, and provide updates within 30 days if this information changes. The contact*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 89 of 108 information must be submitted using EPA’ s electronic data reporting system, as specified in paragraph (b)(1) of this section, and include the name, affiliation, maili ng address, phone number, and email address for your PWS Technical Contact and your PWS Official. In addition, as a one- time reporting requirement, you must report the U.S. P ostal Service Z ip Code (s) for all areas being served water by your PWS.
(2) Sampling location and inventory information. You must provide your sampling location and inventory information by October 1, 2012, using EPA’ s electronic data reporting system. You must submit, verify or update th e following information for each sampling location, or for each approved representative sampling location (as specified in paragraph (c)(3) of this section regarding representative sampling locations): PWS identification (PWSID) code; PWS facility identifi cation code; water source type, sampling point identification code; and sampling point type code; (as defined in Table 1 of paragraph (e) of this section). If this information changes, you must report updates, including new sources and sampling locations t hat are put in use before or during the
PWS ’ UCMR sampling period, to EPA’ s electronic data reporting system within 30 days of the change.

* * * * * (3) * * * (ii) * * * The proposed well must be representative of the highe st annual volume producing and mo st consistently active well s in the representative array. If that representative well is not in use at the scheduled sampling time, you must select and*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 90 of 108 sample an alternative representative well . * * *

* * * * * (5) * * *

( i) General rescheduling notification requirements. Large systems may change their Assessment Monitoring (List 1) schedule up to October 1, 2012, using EPA’ s electronic data reporting system, as specified in paragraph (b)(1) of this section. After these dates have passed, if your PWS cannot sample according to your assigned sampling schedule (e.g., because of budget constraints, or if a sampling location will be closed during the scheduled month of monitoring), you must mail or e mail a letter to EPA, as specified in paragraph (b)(1) of this section, prior to the scheduled sampling date. You must include an explanation of why the samples cannot be taken acc ording to the assigned schedule, and you must provide the alternati ve schedule you are requesting. You are subject to your assign ed UCMR sampling schedule or the schedule that you revised on or before October 1, 2012 , unless and until you receive a letter from EPA specifying a new schedule.

* * * * * (6) Reporting monitoring results. For each sample, you must report all data element s specified in Table 1 of paragraph (e) of this section, using EPA’ s electronic data reporting system. You also must report any changes, relative to what is currently posted, made to data elements 1 through 6 to EPA, in writing, explaining the nature and purpose of the proposed change, as specified in paragraph (b)(1) of this section.
* * * * **** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 91 of 108 (ii) Reporting schedule. You must ensure that your laboratory posts the data to EPA’s electronic data reporting system within 90 days from the sample collection date (sample collection must occur as specified in §141.40(a)(4)). You have 30 days from when the laboratory posts the data in EPA’s electronic data reporting system to review, approve, and submit the data to the State and EPA, at the Web address specified in paragraph (b)(1) of this section. If you do not electronically approve and submit the laboratory data to EPA within 30 days of the laboratory’s posting data to EPA ’ s electronic reporting system, the data will be considered approved by you and available for State and EPA review.

* * * * * (d) * * *
(1) Contact and zip code information. EPA will send you a notice requesting contact information for key individuals at your system, including name, affiliation, maili ng address , phone number and email address. These individuals include your PWS Technical Contact and your PWS Official. You are required to provide this contact information within 90 days of receiving the notice from EPA as specified in paragraph (b)(1) of this sect ion. If this contact information changes, you also must provide updates within 30 days of the change, as specified in paragraph (b)(1) of this section. In addition,

as a one - time reporting requirement, you must report the U.S. P ostal Service Z ip Code (s) fo r all areas being served water by your PWS.
(2) Reporting sampling information . You must record all data elements listed in Table 1*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 92 of 108 of paragraph (e) of this section on each sample form and sample bottle provided to you by the UCMR Sampling Coordinator. You must send this information as specified in the instructions of your sampling kit, which will include the due date and return address. You
must report any changes made in data elements 1 through 6 by mailing or emailing an explanation of the nature and purpose of the proposed change to EPA, as specified in paragraph (b)(1) of this section. (e) * * *

Table 1. Unregulated Contaminant Monitoring Reporting Requirements

Data Element Definition * * * * * * * 6. Disinfectant Type All of the disinfectants that have been added to the water being sampled. To be reported by systems for each sampling point, with possible choices being: CLGA= Gaseous chlorine CLOF = Offsite G enerated Hypochlorite (stored as a liquid form) CLON = Onsite G enerated Hypochlorite (no storage) CAG C = Chloramine (formed from gaseous chlorine) CAOF = Chloramine (formed from off site hypochlorite) CAON = Chloramine (formed from on site hypochlorite) CLD O = Chlorine dioxide O ZON = Ozone ULVL = Ultraviolet L ight OTH D = All Other Types of D isinfectant NOD U = No Disinfectant U sed * * * * * * *

Subpart E

– Special Regulations, Including Monitoring Regulations and Prohibition on
Lead Use

4. Section 141.40 is amended as follows: a. By revising paragraph ( a) introductory text,*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 93 of 108 b. By revising paragraph ( a) (1), c. By revising paragraph (a)(2)(i) introductory text, d. By revising the first sentence of paragraph (a)(2)(i)(A) , e. By revising paragraph (a)(2)(ii) introductory text, f. By revising paragraph (a)(2)(ii)(A) , g. By revising paragraph (a)(2)(ii)(C), h. By revising paragraph (a)(3), i. In paragraph (a)(4)(i) introductory text by remov ing “August 2, 2007” and adding in its place, “October 1, 2012”, j. By revising paragraph ( a)(4)(i) (B), k. By revising paragraph ( a)(4)(i)(C) , l. In paragraph ( a)(4)(i)(D) by removing the last sentence , m. By revising paragraph ( a)(4)(ii)(G) , n. I n paragraph (a)(5)(ii) by remov ing “April 4, 2007” and add ing in its place, “[ INSERT DATE 90 DAYS AFTER DATE OF PUBLICATION IN THE FEDERAL REGISTER ]” and by revising the last sentence , o. By revising paragraph ( a)(5)(iii) introductory text, p. By revising paragraph (a)(5)(iii)(A)( 1 ), q. By revising paragraph (a)(5)(iv), and r. By revising paragraph (a)(5)(vi).

The revisions read as follows:*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 94 of 108 §141.40 Monitoring requirements for unregulated contaminants.

( a) General applicability. This section specifies the monitoring and quality control requirements that must be followed if you own or operate a public water system (PWS) that is subject to the Unregulated Contaminant Monitoring Regulation (UCMR), as specified in paragraphs (a)(1) and (2) of this section. In addition, this section specifies the UCMR requirements for State and Tribal participation. For the purposes of this section, PWS “population served,” “State,” “ PWS Official,” “PWS Technical Contact,” and “finished water” apply as defined in §141.35(a). The determination of whether a PWS is required to monitor under this rule is based on the type of system (e.g., community water system, non- tr ansient non-community water system, etc.), and its retail population, as indicated by SDWIS/Fed on December 31, 2010. (1) Applicability to transient non-community systems. If you own or operate a transient

non- community water system, and you are notified by your State or EPA, you must permit the State, EPA or their contractors to collect samples for the contaminants specified on List 3 of Table 1, in paragraph (a)(3) of this section. (2) * * * (i) Large systems . If you own or operate a retail PWS (other than a transient noncommunity system) that serves more than 10,000 people, you must monitor according to the specifications in this paragraph (a)(2)(i). If you believe that your applicability status is different than EPA has specified in the notification let ter that you received, or if you are subject to UCMR requirements and you have not been notified by either EPA or your*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 95 of 108 State, you must report to EPA, as specified in §141.35(b)(2) or (c)(4). (A) Assessment Monitoring. You must monitor for the unregulated contaminants on List 1 and Total Chromium per Table 1, UCMR Contaminant List, in paragraph (a)(3) of this section. * * *
* * * * * (ii) Small systems . Small PWSs, as defined in this paragraph, will not be selected to monitor for any more than one of the three monitoring lists provided in Table 1, UCMR Contaminant List, in paragraph (a)(3) of this section. EPA will provide sample containers, provide pre- paid air bills for shipping the sampling materials, conduct the laboratory analysis, and report and review monitoring results for all small systems selected to conduct monitoring under paragraphs (a)(2)(ii)(A) through (C) of this section. If you own or operate a PWS that serves 10,000 or fewer people you must monitor as follows: (A) Assessment Monitoring. You must monitor for the unregulated contaminants on List 1 and Total Chromium per Table 1, in paragraph (a)(3) of this section, if you are notified by your State or EPA that you are part of the State Monitoring Plan for Assessment Monitoring.
* * * * * (C) Pre

- Screen Testing. You must allow EPA or its representative to collect samples to support monitoring for the unregulated contaminants on List 3 of Table 1, in paragraph (a)(3) of this section, if you are notified by your State or EPA that you are part of the State Monitoring plan for Pre-Screen Testing. In addition, you must permit the collection*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 96 of 108 of samples as necessary for EPA to perform analysis for total coliforms, E. coli , bacteriophage, Enterococci and aerobic spores. (3) Analytes to be monitored . Lists 1, 2, and 3 of unregulated contaminants and total chromium monitoring are provided in the following table:

Table 1 . UCMR Contaminant List

List 1: Assessment Monitoring Chemical Contaminants 1

- Contaminant 2

- CAS Registry Number 3

- Analytical Methods a 4

- Minimum Reporting Level b 5

- Sampling Location c 6

- Period During Which Monitoring to be Completed
Hormones 17

- β

- estradiol 50

- 28

- 2 EPA 539 d 0.0004 μg/L EPTDS 1/1/2013

- 12/31/2015 17

- α
- ethynylestradiol 57

- 63

- 6 EPA 539 d 0.0009 μg/L EPTDS 1/1/2013

- 12/31/2015 estriol 50

- 27

- 1 EPA 539 d 0.0008 μg/L EPTDS 1/1/2013

- 12/31/2015

e quilin 474

- 86

- 2 EPA 539 d 0.004 μg/L EPTDS 1/1/2013

- 12/31/2015

e strone 53

- 16

- 7 EPA 539 d 0.002 μg/L EPTDS 1/1/2013

- 12/31/2015
t estosterone 58

- 22

- 0 EPA 539 d 0.0001 μg/L EPTDS 1/1/2013

- 12/31/2015 4

- androstene

- 3,17

- dione 63

- 05

- 8 EPA 539 d 0.0003 μg/L EPTDS 1/1/2013

- 12/31/2015 Volatile Organic Compounds 1,2,3

- trichloropropane 96

- 18

- 4 EPA 524.3 e 0.03 μg/L EPTDS 1/1/2013

- 12/31/2015 1,3

- butadiene 106

- 99

- 0 EPA 524.3 e 0.1 μg/L EPTDS 1/1/2013

- 12/31/2015

c hloromethane 74

- 87

- 3 EPA 524.3 e 0.2 μg/L EPTDS 1/1/2013

- 12/31/2015 1,1

- dichloroethane 75

- 34

- 3 EPA 524.3 e 0.03 μg/L EPTDS 1/1/2013

- 12/31/2015

n - propylbenzene 103

- 65

- 1 EPA 524.3 e 0.03 μg/L EPTDS 1/1/2013

- 12/31/2015 b romomethane 74

- 83

- 9 EPA 524.3 e 0.2 μg/L EPTDS 1/1/2013

- 12/31/2015 chlorodifluoromethane (HCFC

22) 75

- 45

- 6 EPA 524.3 e 0.08 μg/L EPTDS 1/1/2013

- 12/31/2015*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 97 of 108 bromochloromethane ( H alon 1011) 74

- 97

- 5 EPA 524.3 e 0.06 μg/L EPTDS 1/1/2013

- 12/31/2015
Synthetic Organic Compound 1,4

- dioxane 123

- 91

- 1 EPA 522 f 0.07 μg/L EPTDS 1/1/2013

- 12/31/2015 Metals

v anadium 7440

- 62

- 2 EPA 200.8 ASTM D5673

- 10 SM 3125 g 0.2 μg/L EPTDS and DSMRT 1/1/2013

- 12/31/2015

m olybdenum 7439

- 98

- 7 EPA 200.8 ASTM D5673

- 10 SM 3125 g 1. μg/L EPTDS and DSMRT 1/1/2013

- 12/31/2015

c obalt 7440

- 48

- 4 EPA 200.8 ASTM D5673

- 10 SM 3125 g 1. μg/L EPTDS and DSMRT 1/1/2013

- 12/31/2015

s trontium 7440

- 24

- 6 EPA 200.8 ASTM D5673

- 10 SM 3125 g 0.3 μg/L EPTDS and DSMRT 1/1/2013

- 12/31/2015

Chromium
- 6 chromium

- 6 k 18540

- 29

- 9 EPA 218.7 h 0.03 μg/L EPTDS and DSMRT 1/1/2013

- 12/31/2015
Oxyhalide Anion

c hlorate 14866

- 68

- 3 EPA 300.1 ASTM D 6581

- 08 SM 4110D i 20 μg/L EPTDS and DSMRT 1/1/2013

- 12/31/2015

Perfluorinated Compounds perfluorooctanesulfonic acid (PFOS) 1763

- 23

- 1 EPA 537 j 0.04 μg/L EPTDS 1/1/2013

- 12/31/2015
perfluorooctanoic acid (PFOA) 335

- 67

- 1 EPA 537 j 0.02 μg/L EPTDS 1/1/2013

- 12/31/2015 perfluorononanoic acid (PFNA) 375

- 95

- 1 EPA 537 j 0.02 μg/L EPTDS 1/1/2013

- 12/31/2015 perfluorohexanesulfonic acid (PFHxS) 355

- 46

- 4 EPA 537 j 0.03 μg/L EPTDS 1/1/2013

- 12/31/2015
perfluoroheptanoic acid 375

- 85

- 9 EPA 537 j 0.01 μg/L EPTDS 1/1/2013

- 12/31/2015*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 98 of 108 List 2: Screening Survey 1

- Contaminant 2

- CAS Registry Number 3

- Analytical Methods a 4

- Minimum Reporting Level b 5

- Sampling Location c 6

- Period During Which Monitoring to be Completed Reserved Reserved Reserved Reserved Reserved Reserved

List 3: Pre
- Screen Testing Microbiological Contaminants 1

- Contaminant 2

- CAS Registry Number 3

- Analytical Methods a 4

- Minimum Reporting Level b 5

- Sampling Location c 6

- Period During Which Monitoring to be Completed

e nteroviruses N/A N/A N/A EPTDS 1/1/2013

- 12/31/2015

n oroviruses N/A N/A N/A EPTDS 1/1/2013

- 12/31/2015

Total Chromium Monitoring 1

- Contaminant 2

- CAS Registry Number 3

- Analytical Methods a 4

- Minimum Reporting Level b 5

- Sampling Location c 6

- Period During Which Monitoring to be Completed total chromium N/A EPA 200.8 ASTM D5673

- 10 SM 3125 g 0.2 μg/L EPTDS and DSMRT 1/1/2013

- 12/31/2015

Column headings are: 1-Contaminant: the name of the contaminant to be analyzed.
2- CAS (Chemical Abstract Service) Registry Number or Identification Number: a unique number identifying the chemical contaminants. (PFHpA) perfluorobutanesulfonic acid (PFBS) 375

- 73

- 5 EPA 537 j 0.09 μg/L EPTDS 1/1/2013

- 12/31/2015*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 99 of 108 3-Analytical Methods: method numbers identifying the methods that must be used to test the contaminants. For List 3, analysis will only be performed by laboratories under
contract to EPA.
4- Minimum Reporting Level: the value and unit of measure at or above which the concentration of the contaminant must be measured using the approved analytical methods. If EPA determines, after the first six months of monitoring, that the MRLs specified in UCMR 3 result in excessive resampling, EPA will establish alternate MRLs and will notify affected PWSs and laboratories of the new MRLs. For List 3, minimum reporting level is based on volume of water filtered and PCR amplification level.
5- Sampling Location: the locations within a PWS at which samples must be collected. 6-Period During Which Monitoring to b e Completed: the time period during which the sampling and testing will occur for the indicated contaminant.

a Th e analytical procedures shall be performed in accordance with the documents associated with each method (per the following footnotes). The incorporation by reference of the following documents listed in footnotes d through j was approved by the Director of the Federal Register in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Information on how to obtain these documents can be provided by the Safe Drinking Water Hotline at (800) 426-4791. Publically available docket materials are available either electr onically in www.regulations.gov or in hard copy at the Water Docket. The Docket ID is EPA

- OW -2009-0090. Hard copies of these documents may be viewed at the Water Docket in the EPA Docket Center, (EPA/DC) EPA West, R oom 3334, 1301 Constitution Avenue, NW, Washington, DC. The EPA Docket Center Public Reading*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 100 of 108 Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Public Reading Room is (202) 566-1744, and the telephone number for the Water docket is (202) 566-2426. Copyrighted materials are only available for viewing in hard copy. These documents may also be viewed at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 1 -866-272-6272 or go to: http://www.archives.gov/locations/

. b The m inimum reporting l evel (MRL) is the minimum concentration of each analyte that must be reported to EPA.

c Sampling must occur at entry points to the distribution system (EPTDSs) after treatment is applied that represent each non- emergency water source in routine use over the 12

- month period of monitoring. Systems that purchase water with multiple connections from the same wholesaler may select one representative connection from that wholesaler. This EPTDS sampling location must be representative of the highest annual volume connections. If the connection selected as the representative EPTDS is not available fo r sampling, an alternate highest volume representat ive connection must be sampled. See 40 CFR 141.35(c)(3) for an explanation of the requirements related to use of representative ground water EPTDSs. Sampling for total chromium, chromium-6, cobalt, molybdenum, strontium, vanadium, and chlorate must be conducted at distribution system maximum residence time (DSMRT) sampling locations. DSMRT is defined as an active point (i.e., a location that currently provides water to customers) in the distribution system where the water has been in the system the longest relative to the EPTDS

.*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 101 of 108 d EPA Method 539 “Determination of Hormones in Drinking Water by Solid Phase Extraction (SPE) and Liquid Chromatography Electrospray Ionization Tandem Mass Spectrometry (LC

- ESI

- MS/M S) ,” Version 1.0, November 2010, EPA 815-B-10-001 is available at http://water.epa.gov/scitech/drinkingwater/labcert/analyticalmethods_ogwdw.cfm

.

e EPA Method 524.3 “Measurement of Purgeable Organic Compounds in Water by Capillary Column Gas Chromatography/Mass Spectrometry,” Version 1.0, June 2009, EPA 815-B-09-009 is available at http://water.epa.gov/scitech/drinkingwater/labcert/analyticalmethods_ogwdw.cfm

. f EPA Method 522 “Determination of 1,4-Dioxane in Drinking Water by Solid Phase
Extra ction (SPE) and Gas Chromatography/Mass Spectrometry (GC/MS) with Selected Ion Monitoring (SIM),” Version 1.0, September 2008 , EPA 600-R-08-101 is available at http://www.epa.gov/nerlcwww/ordmeth.htm

.
g EPA Method 200.8 “Determination of Trace Elements in Waters and Wastes by Inductively Coupled Plasma - Mass Spectrometry,” Version 5.4, 1994 is available at http://www.NEMI.gov

. ASTM D5673-10 “Standard Test Method for Elements in Water by Inductively Coupled Plasma

- Mass Spectrometry ,” is available for purchase at http://www.astm.org/Standards/D5673.htm

. SM 3125 “ Metals by Inductively Coupled Plasma/Mass Spectrometry ,” Standard Methods for the Examination of Water and Wastewater , 21 st edition (2005). American Public Health Association, 800 I Street, NW, Washington, DC 20001-3710.*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 102 of 108 h EPA Method 218.7 “Determination of Dissolved Hexavalent Chromium in Drinking Water by Ion Chromatography,” Version 1.0, September 2011, EPA TSC-3-0768 is available at http://water.epa.gov/scitech/drinkingwater/labcert/analyticalmethods_ogwdw.cfm

. i EPA Method 300.1 “Determination of Inorganic Anions in Drinking Water by Ion Chromatography,” Revision 1.0, 1997 is available at http://water.epa.gov/scitech/drinkingwater/labcert/analyticalmethods_ogwdw.cfm

. ASTM D6581-08 “Standard Test Methods for Bromate, Bromide, Chlorate, and Chlorite in Drinking Water by Suppressed Ion Chrom atography ,” Available for purchase on the
Internet at http://www.astm.org/Standards/D6581.htm

. SM 4110D “Determination of Anions by Ion Chromatography, Part D, Ion Chromatography Determination of Oxyhalides and Bromide ,” Standard Methods for the Examination of Water and Wastewater , 21 st edition (2005). American Public Health Association, 800 I Street, NW, Washington, DC 20001-3710.
j EPA Method 537 “Determination of Selected Perfluorinated Alkyl Acids in Drinking Water by Solid Phase Extraction and Liquid Chromatography/Tandem Mass Spectrometry (LC/MS/MS) ,” Version 1.1, September 2009 , EPA 600-R-08-092 is available at http://www.epa.gov/nerlcwww/ordmeth.htm

. k Chromium-6 will be measured as soluble chromate ion (CAS Registry Number 13907-
45- 4).

* * * * **** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 103 of 108 (4) * * * (i) * * *
(B) Frequency. You must collect the samples within the time frame and according to the frequency specified by contaminant type and water source type for each sampling location, as specified in Table 2, in this paragraph. For the second or subsequent round of sampling, if a sample location is non -operational for more than one month before and one month after the scheduled sampling month ( i.e. , it is not possible for you to sample within the window specified in Table 2, in this paragraph), you must notify EPA as specified in §141.35(c)(5) to reschedule your sampling.

Table 2 . Monitoring Freque ncy by Contaminant and Water Source Types Contaminant Type Water Source Type Time Frame Frequency Chemical Surface water or ground water under the direct influence of surface water (GWUDI) (includes all sampling locations for which some or all of the water comes from a surface water or GWUDI source at any time during the 12 month monitoring period) 12 months You must monitor for 4 consecutive quarters. Sample events must occur 3 months apart.

Ground water 12 months You must monitor twice in a consecutive 12-month period. Sample events must occur 5 - 7 months apart.*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 104 of 108 Microbiological Ground water 12 months You must monitor twice in a consecutive 12-month period. Sample events must occur 5 - 7 months apart.

(C) Location . You must collect samples for each List 1 Assessment Monitoring contaminant, and, if applicable, for each List 2 Screening Survey, or List 3 Pre- Screen Testing contaminant, as specified in Table 1, in paragraph (a)(3) of this section. Samples must be collected at each sample point that is specified in column 5 and footnote c of Table 1, in paragraph (a)(3) of this section. If you are a ground water system with multiple EPTDSs, and you request and receive approval from EPA or the State for sampling at repre sentative EPTDS(s), as specified in §141.35(c)(3), you must collect your samples from the approved representative sampling location(s). Systems conducting Assessment Monitoring must also sample for total chromium, chromium-6, cobalt, molybdenum, strontium, vanadium, and chlorate at the location that represents the maximum residence time in the distribution system (DSMRT ). DSMRT is defined as an active point (i.e., a location that currently provides water to customers) in the distribution system where the water has been in the system the longest relative to the EPTDS

.

(ii) * * *

* * * * *
(G) Sampling forms. You must completely fill out each of the sampling forms and bottles*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 105 of 108 sent to you by the UCMR Sampling Coordinator, including data elements listed in §141.35(e) for each sample, as specified in §141.35(d)(2). You must sign and date the sampling forms.

* * * * * (5) * * *
* * * * * (ii) * * * Correspondence must be addressed to: UCMR Laboratory Approval Coordinator, USEPA, Technical Support Center, 26 West Martin Luther King Drive, (MS 140), Cincinnati, OH 45268; or emailed to EPA at: UCMR_Sampling_Coordinator@epa.gov. (iii) Minimum Reporting Level. The MRL is an estimate of the quantitation limit

. Assuming good instrumentation and experienced analysts, an MRL is achievable , with 95% confidence, by 75 % of laboratories nationwide. (A) * * *
( 1) All laboratories performing analysis under UCMR must demonstrate that they are capable of meeting data quality objectives at or below the MRL listed in Table 1, column 4, in paragraph (a)(3) of this section.

* * * * *

(iv) Laboratory fortified sample matrix and laboratory fortified sample matrix duplicate.*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 106 of 108 You must ensure that your laboratory prepares and analyzes the Laboratory Fortified Sample Matrix (LFSM) sample for accuracy and Laboratory Fortified Sample Matrix Duplicate (LFSMD) samples for precision to determine method accuracy and precision for all c ontaminants in Table 1, in paragraph (a)(3) of this section. LFSM/LFSMD samples must be prepared using a sample collected and analyzed in accordance with UCMR requirements and analyzed at a frequency of 5% (or 1 LFSM/LFSMD set per every 20 samples) or with each sample batch, whichever is more frequent. In addition, the LFSM/LFSMD fortification concentrations must be alternated between a low

- level fortification and mid

- level fortification approximately 50% of the time. (For example: a set of 40 samples will require preparation and analysis of 2 LFSM/LFSMD paired samples. The first LFSM/LFSMD paired sample set must be fortified at either the low

level or mid

- level, and the second LFSM/LFSMD paired sample set must be fortified with the other standard, either th e low

- level or mid

- level, whichever was not used for the initial LFSM/LFSMD paired sample set.) The low

- level LFSM/LFSMD fortification
concentration must be within **±** 50% of the MRL for each contaminant (e.g., for an MRL of 1 μ g/L the acceptable fortificatio n levels must be between 0.5 μg/L and 1.5 μg/L). The
mid

- level LFSM/LFSMD fortification concentration must be within **±** 20% of the midlevel calibration standard for each contaminant, and is to represent, where possible and where the laboratory has data from previously analyzed samples, an approximate average concentration observed in previous analyses of that analyte. There are no UCMR contaminant recovery acceptance criteria specified for LFSM/LFSMD analyses. All LFSM/LFSMD data are to be reported.*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 107 of 108 * * * * *

(vi) Reporting You must require your laboratory to submit these data electronically to the State and EPA using EPA’ s electronic data reporting system, accessible at ( htt p://water.epa.gov/lawsregs/rulesregs/sdwa/ucmr/ucmr3/reporting.cfm ), within 90 days from the sample collection date. You then have 30 days from when the laboratory posts the data to review, approve and submit the data to the State and EPA, via EPA’ s electr onic data reporting system. If you do not electronically approve and submit the laboratory data to EPA within 30 days of the laboratory posting data to EPA ’ s electronic reporting system, the data will be considered approved and available for State and EPA review.
* * * * *

PART 14 2 - NATIONAL PRIMARY DRINKING WATER REGULATIONS IMPLEMENTATION

5. The authority c itation for p art 14 2 continues to read as follo ws: Authority: 42 U.S.C. 300f, 300g-1, 300g-2, 300g-3, 300g-4, 300g-5, 300g-6, 300j-4, 300j-9, and 300j-11.

Subpart B

– Primary Enforcement Responsibility

6. Section 142.16 is amended as follows:*** E.O. 12866 Review – Draft – Do Not Cite, Quote, or Release During Review ***

Page 108 of 108 a. In paragraph (j) introductory text by removing “§141.40”. b. In paragraph (j)(1) by revising the first sentence.

§142.16 Special primacy requirements.

* * * * * (j) * * *
(1) If a State chooses to issue waivers from the monitoring requirements in §§141.23 and 141.24, the State shall describe the proc edures and criteria which it will use to review waiver applications and issue wavier determinations. * * *

* * * * *