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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 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
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
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.
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)
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
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
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
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.”
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
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
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
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
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.
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
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
(µ
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
(µ
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
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
(µ
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
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
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
U.S. EPA Regulatory Update October 2013 19
U.S. EPA Regulatory Update
Questions
U.S. EPA Regulatory Update
Other Regulatory Development Activities
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
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.
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
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
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.
U.S. EPA Regulatory Update October 2013 25
U.S. EPA Regulatory Update
Questions
(312) 886-5253
Miguel A. Del Toral