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U.S. EPA Regulatory Update October 2013 1 U.S. EPA Regulatory Update U.S. EPA Regulatory Update Miguel A. Del Toral October 3, 2013 U.S. EPA Regulatory Update Outline • Regulatory Development Process • Revisions to Existing Law/Regulations Revised Total Coliform Rule Reduction of Lead in Drinking Water Act Lead and Copper Rule Long-Term Revisions • Other Regulatory Development Activities

U.S. EPA Regulatory Update · U.S. EPA Regulatory Update October 2013 2 U.S. EPA Regulatory Update Generalized Flow of Regulatory Processes At each stage, need increased specificity

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Page 1: U.S. EPA Regulatory Update · U.S. EPA Regulatory Update October 2013 2 U.S. EPA Regulatory Update Generalized Flow of Regulatory Processes At each stage, need increased specificity

U.S. EPA Regulatory Update October 2013 1

U.S. EPA Regulatory Update

U.S. EPA Regulatory Update

Miguel A. Del ToralOctober 3, 2013

U.S. EPA Regulatory Update

Outline

• Regulatory Development Process

• Revisions to Existing Law/Regulations

� Revised Total Coliform Rule

� Reduction of Lead in Drinking Water Act

� Lead and Copper Rule Long-Term Revisions

• Other Regulatory Development Activities

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U.S. EPA Regulatory Update October 2013 2

U.S. EPA Regulatory Update

Generalized Flow of Regulatory Processes

At each stage, need increased specificity and confidence in the type

of supporting data used (e.g. health and occurrence).

Draft CCL

Final CCL

Final Rule

(NPDWR)Six Year Review of

Existing NPDWRs

No further action if

make decision to not to

regulate (may develop

health advisory).

Preliminary

Regulatory

Determinations

Final Regulatory

Determinations

Proposed Rule

(NPDWR)

Public review and comment

Draft UCMR

Final UCMR

UCMR Monitoring

Results

U.S. EPA Regulatory Update

Revisions to Existing Regulations

• Original Total Coliform Rule and Lead and Copper Rule promulgated in 1989 & 1991

• Revised Total Coliform Rule (RTCR)

� Proposed July 2010

� Final Rule: February 13, 2013

• Lead and Copper Rule Long-Term Revisions (LCR-LTR)

� Proposed Rule: TBD - 2015?

� Final Rule: TBD

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U.S. EPA Regulatory Update October 2013 3

U.S. EPA Regulatory Update

Revised Total Coliform Rule(RTCR)

Additional Information (U.S. EPA Website):http://water.epa.gov/lawsregs/rulesregs/sdwa/tcr

U.S. EPA Regulatory Update

RTCR Major General ProvisionsMCLs

• Total Coliform MCL replaced with Assessment &

Corrective Action (A/CA) Requirement

• Acute MCL based on TC/E. coli monitoring results

� Fecal coliform is no longer used

• Acute (E. coli) MCL is assessed as follows:

� The system has an E. coli (+) repeat sample following a TC

(+) routine sample.

� The system has a TC (+) repeat sample following an E. coli

(+) routine sample.

� The system fails to take all required repeat samples following

an E. coli (+) routine sample.

� The system fails to test for E. coli when any repeat sample

tests (+) for TC.

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U.S. EPA Regulatory Update October 2013 4

U.S. EPA Regulatory Update

RTCR Major General ProvisionsAssessments

• Level 1 (L1) Assessment triggers

� For a system collecting at least 40 samples per

month, more than 5.0% of samples collected are

TC(+)

� For a system collecting fewer than 40 samples per

month, no more than one sample is TC(+)

� Failure to collect all repeat samples

U.S. EPA Regulatory Update

RTCR Major General ProvisionsAssessments

• Level 2 (L2) Assessment triggers

� E. coli MCL violation

� Two L1 triggers in a rolling 12 month period

� A L1 trigger in each of 2 consecutive years

(NCWSs on annual monitoring)

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U.S. EPA Regulatory Update October 2013 5

U.S. EPA Regulatory Update

RTCR Major General ProvisionsAssessments

• Basic Elements of Assessments

• Look at atypical events that may affect distributed water quality or

indicate that distributed water quality was impaired

• Review changes in distribution system maintenance and

operation that may affect distributed water quality, including water

storage

• Evaluate source and treatment considerations that bear on

distributed water quality

• Review/evaluate Existing water quality monitoring data

• Determine if there are inadequacies in sample sites, sampling

protocol, and sample processing

U.S. EPA Regulatory Update

RTCR Major General ProvisionsCorrective Action

• Systems must correct all sanitary defects found during

assessments

• “Sanitary defects” and Corrective Actions must be

described in the Assessment form

� PWS must submit assessment to the State within 30 days

� State may require more immediate action by PWS

• A timetable for any Corrective Actions not already

completed must also be in the form.

� The State will determine a schedule after consulting with the

PWS

• The State determines if the Assessment is sufficient

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U.S. EPA Regulatory Update October 2013 6

U.S. EPA Regulatory Update

RTCR Major General ProvisionsMonitoring Requirements

• Sampling plans required for all systems

• Systems taking at least 1 routine sample per

month

� Requirement for five additional routine samples

following TC(+) result has been eliminated

• Systems sampling less frequently than monthly

� Number of additional routine samples required

reduced from 5 to 3

• Reduced repeat monitoring from 4 samples to 3

samples per TC(+) result for PWS ≤ 1,000

U.S. EPA Regulatory Update

RTCR Provisions(specific requirements)

• Seasonal systems

� Implement a State-approved start-up procedure

� Monitor monthly or during most vulnerable time period.

• New requirements for community and non-community systems to reduce monitoring or remain on reduced monitoring

• Many different State approaches to implementing the RTCR� Anticipate that States RTCR programs will vary

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U.S. EPA Regulatory Update October 2013 7

U.S. EPA Regulatory Update

RTCR Guidance/Training(under development)

• A Small Systems Guide to the Revised Total Coliform

Rule

• Revised Total Coliform Rule: A Quick Reference Guide

• RTCR laboratory quick reference guide

• Fact sheets, placards

• Assessments and Corrective Actions Guidance

• Webcasts for States and PWSs (beginning in Fall 2013)

U.S. EPA Regulatory Update

Questions

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U.S. EPA Regulatory Update October 2013 8

U.S. EPA Regulatory Update

Reduction of Lead in Drinking Water Act(Effective January 2014)

U.S. EPA Regulatory Update

Reduction of Lead in Drinking Water Act

• SDWA Amendment (signed Jan 5, 2011)

� Prohibits any pipe or plumbing fixture that is not

lead-free to be introduced into commerce after

Jan 4, 2014.

� Revises the definition of ‘Lead-Free’ to: “not more

than a weighted average of 0.25 percent lead

when used with respect to the wetted surfaces of

pipes, pipe fittings, plumbing fittings, and fixtures.”

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U.S. EPA Regulatory Update October 2013 9

U.S. EPA Regulatory Update

Reduction of Lead in Drinking Water Act

• EPA-ORD Brochure on Lead-Free Certification Marks

� Assist general public and public water systems to identify lead-free plumbing materials using certification marks

U.S. EPA Regulatory Update

Reduction of Lead in Drinking Water Act

• EPA published draft ‘frequently asked questions’ on website:

� Comments received from 150+ organizations and individuals

� Final FAQs anticipated before end of the calendar year, if not sooner

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U.S. EPA Regulatory Update October 2013 10

U.S. EPA Regulatory Update

How to Identify Lead-Free Certification Marks

http://nepis.epa.gov/Exe/ZyPDF.cgi?Dockey=P100GRDZ.txt

Lead-free Draft FAQ

http://water.epa.gov/drink/info/lead/upload/epa815p13xxx.pdf

Reduction of Lead in Drinking Water Act

U.S. EPA Regulatory Update

Questions

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U.S. EPA Regulatory Update October 2013 11

U.S. EPA Regulatory Update

Lead and Copper Rule Long-Term Revisions

(LCR-LTR)

Additional Information (U.S. EPA Website):http://water.epa.gov/lawsregs/rulesregs/sdwa/lcr

U.S. EPA Regulatory Update

Lead & Copper RuleLong-Term Revisions

• Original rule was promulgated in 1991

� Many studies have been conducted since 1991 on

corrosion and corrosion control

� Lessons learned from systems attempting to

simultaneously comply with multiple NPDWRs

• Several relatively minor revisions have been

made to the rule since 1991

• Significant issues left for LCR ‘Long-Term’

revisions

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U.S. EPA Regulatory Update October 2013 12

U.S. EPA Regulatory Update

Lead & Copper RuleLong-Term Revisions

The goal for the LCR Long-Term Revisions is to improve public health protection provided by the LCR by making substantive changes based on topics that were identified in the 2004 National Review, and to streamline the rule requirements.

U.S. EPA Regulatory Update

Lead & Copper RuleLong-Term Revisions

•Challenges� LCR is the most complex rule� Simultaneous compliance has resulted in unintended consequences for some systems

� Not all problems affect all systems•Systems with and without lead service lines•Infrastructure work can affect lead levels•Water quality differences •Ground water and surface water systems can have different issues

� Current rule provisions are outdated, and rule requirements are prescriptive/inflexible

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U.S. EPA Regulatory Update October 2013 13

U.S. EPA Regulatory Update

Lead & Copper RuleLong-Term Revisions

• Potential Changes

� Sample site selection criteria (lead and copper)

� Sampling procedures for lead and copper tap monitoring

� Public education for lead and copper

� Corrosion control treatment & process control

� Lead service line replacement requirements

� Remove/revise outdated requirements

� Streamline rule requirements for systems

� Other Issues

U.S. EPA Regulatory Update

Sampling ProtocolJust to Highlight One Area

• EPA Region 5 and Chicago DWM partnered to conduct a sampling study

� Evaluate the current sampling used by public water systems to monitor lead levels.

� Three rounds of comparative stagnation sampling by volunteers in 32 single-family homes in Chicago.

� To inform EPA during Lead and Copper Rule revisions.

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U.S. EPA Regulatory Update October 2013 14

U.S. EPA Regulatory Update

All samples � Volume = 1 liter; Stagnation time >= 6 hours

Three rounds of monitoring:1) Mar/Apr 2011

� first-draw

� flushed: 45 sec

2) June 2011� 12 sequential

3) Sept/Oct 2011� 11+ sequential

� first-draw

� flushed: 3, 5, 7 minute

• “First-draw” included normal household use or pre-flushing

prior to stagnation

Lead Sampling Study Sampling Protocols

First-Draw :: 1st Sequential :: LCR-Type Compliance Samples

U.S. EPA Regulatory Update

Lead Sampling StudyConducted 2011-2012 / Published 2013

• Major Findings: Lead service line (LSL) sites

� Regulatory sampling can significantly underestimate peak lead levels

� High Variability in Pb levels within and across sampling sites

� Pb higher in warmer months

� Sites with physical disturbances to LSLs had highest Pb levels

� Advising residents to flush for 30 to 45 seconds can increase residents lead exposure

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U.S. EPA Regulatory Update October 2013 15

U.S. EPA Regulatory Update

Lead Sampling StudyFirst Draw and 45-sec Flushed Samples

0

5

10

15

20

25

30

35

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38

Le

ad

g/L

)

Site

1st Draw (Normal Household Use) 45-Sec Flush (Normal Household Use)

Lead Action Level

Results � EPA’s ‘30 to 45 second’ flushing guidance

can take residents with LSLs to higher lead.

U.S. EPA Regulatory Update

0

5

10

15

20

25

30

FirstDraw

Sample

Liter 2 Liter 3 Liter 4 Liter 5 Liter 6 Liter 7 Liter 8 Liter 9 Liter 10 Liter 11 Liter 12

Lead

g/L

)

June 2011 90th %ile Chicago Compliance Data 90th %ile (1999-2009 Ave)*

Lead Sampling StudySequential Sampling Results

Peak values above 30 µg/L at some sites

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U.S. EPA Regulatory Update October 2013 16

U.S. EPA Regulatory Update

Lead Sampling Study High Variability Within and Across Sites

0

5

10

15

20

25

30

35

40

8 1 29 10 12 30 9 27 7 33 31 3 23 21 35 36 24 5 18 25 17 22 32 4 28 13 26 19 11 38 6 34

Lead

g/L

)

Site

Sequential Sample Results (June – Oct 2011)

Ave (ug/L) Bars = Min. and Max.

Most variable site Least variable site

U.S. EPA Regulatory Update

# of Disturbed Sites 13

36%over 15 μg/L

Total Samples Collected 327

# Samples Above 15 μg/L 117

# of Undisturbed Sites 16

2 %over 15 μg/L

Total Samples Collected

(Undisturbed) 372

# Samples above 15 μg/L 6

Note: May be link between disturbed sites and low water usage.

Lead Sampling Study Sites with disturbed lead service lines had highest lead

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U.S. EPA Regulatory Update October 2013 17

U.S. EPA Regulatory Update

Follow up work

Sediment/Scale � Primarily Aluminum,

Phosphorous & Calcium

•330,000 μg/L Pb in particulate sample

•125,000 μg/L Pb in suspended sample

Disturbance to LSL

Dislodged High-Pb

Scale/Sediment

U.S. EPA Regulatory Update

Lead Sampling StudyEPA Region 5 website

• Provides advice for resident with LSLs

� Chicago lead sampling study findings• Study can be downloaded from EPA website or Environmental

Science & Technology Journal Website

� How to find out if you have a LSL

� Cleaning aerators

� Revised flushing instructions

� Recommendations for collecting water samples

For more information: http://www.epa.gov/Region5/water/chicagoserviceline/index.html

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U.S. EPA Regulatory Update October 2013 18

U.S. EPA Regulatory Update

Flushing Recommendations Following LSL Disturbances

U.S. EPA Regulatory Update

Lead & Copper RuleLong-Term Revisions (Next Steps)

• Consultation with NDWAC on Lead and Copper Issues� FR notice – http://www.gpo.gov/fdsys/pkg/FR-2013-08-

07/pdf/2013-19080.pdf

• Revise Guidance Manual for Corrosion Control Treatment (under development)� Update GM to include the latest science and understanding

of corrosion and corrosion control treatment� Include step-by-step templates to guide public water

systems and States through the entire optimal corrosion control treatment installation and evaluation process

• Promulgate proposed rule changes for public comment

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U.S. EPA Regulatory Update October 2013 19

U.S. EPA Regulatory Update

Questions

U.S. EPA Regulatory Update

Other Regulatory Development Activities

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U.S. EPA Regulatory Update October 2013 20

U.S. EPA Regulatory Update

Regulatory Development

• Regulatory Determinations (3rd round)

• Perchlorate

• Chromium VI

• Fluoride

• U.S. EPA Drinking Water Strategy

� Carcinogenic VOCs

U.S. EPA Regulatory Update

RegulatoryDeterminations

Round 3

Additional Information (U.S. EPA Website):http://water.epa.gov/lawsregs/rulesregs/sdwa/ccr

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U.S. EPA Regulatory Update October 2013 21

U.S. EPA Regulatory Update

Generalized Flow of Regulatory Processes

At each stage, need increased specificity and confidence in the type

of supporting data used (e.g. health and occurrence).

Draft CCL

Final CCL

Final Rule

(NPDWR)Six Year Review of

Existing NPDWRs

No further action if

make decision to not to

regulate (may develop

health advisory).

Preliminary

Regulatory

Determinations

Final Regulatory

Determinations

Proposed Rule

(NPDWR)

Public review and comment

Draft UCMR

Final UCMR

UCMR Monitoring

Results

U.S. EPA Regulatory Update

Regulatory Determinations

• The SDWA directs EPA to publish a Contaminant Candidate List

(CCL) to assist in priority-setting efforts and EPA must select five or

more contaminants from the CCL and determine whether to regulate

them (regulatory determinations).

• To regulate a contaminant SDWA requires that EPA determine

whether:

� The contaminant may have an adverse effect on the health of

persons;

� The contaminant is known to occur or there is a substantial

likelihood the contaminant will occur in public water systems with

a frequency and at levels of public health concern; and

� In the sole judgment of the Administrator, regulation of the

contaminant presents a meaningful opportunity for health risk

reductions for persons served by public water systems.

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U.S. EPA Regulatory Update October 2013 22

U.S. EPA Regulatory Update

Regulatory DeterminationsRound 3

• The third final Contaminant Candidate List (CCL 3) list

includes 104 chemicals or chemical groups and 12

microbiological contaminants.

• As of today, EPA has not made final decisions on these

contaminants, but may still do so this year.

• EPA requested nominations for CCL 4 in May 2012 and

may propose CCL 4 in early 2014.

U.S. EPA Regulatory Update

Perchlorate

Additional Information (U.S. EPA Website):http://water.epa.gov/drink/contaminants/unregulated/perchlorate.cfm

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U.S. EPA Regulatory Update October 2013 23

U.S. EPA Regulatory Update

Perchlorate Regulatory Determination

• On February 11, 2011, EPA published its decision to

regulate perchlorate.

• This decision reversed a 2008 preliminary

determination and considered input from almost

39,000 public commenters.

• Science Advisory Board convened panel to review

perchlorate and held a public meeting on perchlorate

in December 2012 and submitted its report to EPA in

May 2013.

• Statutory deadline for Perchlorate proposal was Feb

2013.

• My guess is it will slip into 2014.

U.S. EPA Regulatory Update

Carcinogenic VOCs

Additional Information (U.S. EPA Website):http://water.epa.gov/lawsregs/rulesregs/sdwa/dwstrategy/upload/FactSheet_DrinkingWaterStrategy_VOCs.pdf

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U.S. EPA Regulatory Update October 2013 24

U.S. EPA Regulatory Update

• In 2010 EPA decided to re-evaluate TCE and PCE

under the 6-year review process.

• In 2011, the EPA Administrator asked OGWDW to look

into regulating contaminants as a group.

• EPA began with Carcinogenic VOCs (including TCE

and PCE in that group).

• The cVOC group may include up to six additional

regulated VOCs and up to eight unregulated VOCs

from the EPA's Contaminant Candidate List 3.

Carcinogenic VOC Group

U.S. EPA Regulatory Update

Carcinogenic VOC Group

• All cVOCs must meet the following four criteria to be

considered for inclusion:

� have a similar health endpoint (cancer);

� be measured by the same analytical method (EPA method 524.3);

� be treated by the same the same method (PTA or GAC); and

� occur in drinking water individually and possibly co-occur.

• EPA is still in the early stages of rule development for the

carcinogenic volatile organic chemicals (cVOC) rule.

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U.S. EPA Regulatory Update October 2013 25

U.S. EPA Regulatory Update

Questions

[email protected]

(312) 886-5253

Miguel A. Del Toral