Regulatory Update
CA-NV Conference
Adam Carpenter
Regulatory Analyst
AWWA - Washington
Presentation Outline
• Summary of regulatory history
• Current regulatory update
– Already released in 2014
– To be released in the balance of 2014
– Coming out in 2015 (might slip to 2016)
• What the future might hold
Regulatory History
• 19 regulations for 91 contaminants
between 1975-2013
• Nine prior to 1996 SDWA Amendments
– Primarily numerical MCLs based on annual
average of quarterly samples
• Ten after 1996 SDWA Amendments
– Harder to treat contaminants and/or more
complex regulations
Where We Are Today
0
20
40
60
80
100
120
NIPDWR
Phase II, LCR
TTHMR
1980
Phase I
SWTR,TCR
Phase II
19902000
2010
CCRR,Stage 1 DBPR,
IESWTR
Radionuclides, PNR
Arsenic, SFBR
GWR, LT2ESWTR,
Stage 2 DBPR
ST-LCRRTCR
ICR
Number of Regulated Contaminants
Drinking Water Regulations
The First Main Regulatory Process
In the 1996 SDWA
1. New contaminants that might be of concern-Contaminant Candidate List (CCL)
– CCL1 in 1998 - 5 year cycle thereafter
– Regulatory Determinations (RDs) for at least 5• First in 2003 and then every 5 years
• Determinations: regulate, not regulate, issue health advisory, needs more research
– If a determination is made to regulate, then proposal 24 months after and final 36 months after determination
The Second Main Regulatory Process
In the 1996 SDWA
2. Six-Year Review of all existing drinking
water regulations
– Takes into account new health effects,
occurrence, treatment, and/or analytical
methods data
• Is it worthwhile to revise the regulation?
• No SDWA deadlines for proposal/final after the
decision is made to revise
Six Year Review of Existing
NPDWRs
Proposed CCL
Final CCL Preliminary Regulatory
Determinations
Final Regulatory
Determinations
Final Rule (NPDWR)
No Regulatory
Action
Proposed Rule (NPDWR)
Draft UCMR
UCMR Observations
Final UCMR
Source: Adapted from EPA presentation (April, 2010)
SDWA Standard Setting Process
History of CCLs, RDs, and Six-Year ReviewsDate Regulatory Action
1998 CCL1 60 Contaminants
2003 RD1 Do Not Regulate 9
2003 Six-Year 1 Revise Total Coliform Rule
2005 CCL2 51 Contaminants
2008 RD2 Do Not Regulate 11
2009 CCL3 116 Contaminants
2010 Six-Year 2 Revise Four Standards
2014 RD3 (proposal) Regulate 1, do not regulate 4
Off-Cycle Positive Regulatory Determination for perchlorate in 2011
Six Regulatory Actions in 2014
1. Final cybersecurity framework and EPA evaluation
2. Proposed definition of waters of the US
3. Proposed ambient water quality criteria for human health protection
4. Advanced notice of rulemaking for fracking chemicals and mixtures
5. Chemical safety report
6. Proposed Clean Power Plan
Cybersecurity Framework
• Executive Order 13636 – Improving
Critical Infrastructure Cybersecurity
– Draft framework – October 2013
– Final framework – February 2014
– National Institute of Standards and Technology
(NIST) led framework development
– Agencies will seek to support adoption of final
framework
AWWA Guidance and Tool
• AWWA WITAF Project #503
– Developed water sector guidance and tool
that provides a course of action for systems to
adopt NIST framework
– Released Feb. 2014
– Webinars and training ongoing
– For the moment, EPA has accepts voluntary
approach using AWWA guidance and tool
• Need strong response from water sector to
demonstrate use/adoption
Waters of the US
• April 21st – Corps/EPA published new
definition for Waters of the US (WOTUS)
– Lots of concerns with the proposal
• Several exemptions but lack of clarity for others
• AWWA is evaluating the proposal to
determine what our comments might (or
might not) say, and has made a visual
guide available on www.awwa.org
Ambient Water Quality Criteria
• May 13th – EPA proposal for Ambient
Water Quality Criteria for the protection of
human health under Clean Water Act
– Some revised assumptions
• 80 kg body weight (from 70 kg)
• 3 L/day drinking water (from 2 L/day)
• AWWA submitted comments
Fracking Chemicals & Mixtures
• May 19th – EPA released Advance Notice
of Primary Rulemaking (ANPR) for
fracking chemicals and mixtures
– Asked over 50 questions of potential data
elements and data collection approaches
• AWWA submitted comments
Chemical Safety Report
• Executive Order 13650 – Improving Chemical Facility Safety and Handling– Result of Texas fertilizer plant explosion
– Improved local coordination
– Enhanced federal coordination and information collection and sharing
– Policy, regulation, and standards modernization
– Identification of best practices
• EPA is evaluating existing programs– Request for Information for Risk Mgmt. Program
Clean Power Plan
• Climate Policy is the highest stated priority for
the Administration
• Potential for water and wastewater systems to
receive energy efficiency money while GHG
controls roll out
– Needs to be part of the national rule as well as
state-level compliance plans
– Significant work at the state level – need your help
Current Regulatory Schedule
The balance of 2014 (?) Coming out in 2015 (or later)
Preliminary Third Regulatory Determination (in prepublication)
Proposed Lead and Copper Rule Long-Term Revisions (LCR-LTR) (probably 2016)
Draft Fourth Contaminant Candidate List (CCL4)
Proposed Perchlorate Rule
Final recommended fluoride level for drinking water (from HHS)
Proposed Carcinogenic Volatile Organic Compound (cVOC) Rule
Proposed Fourth Unregulated Contaminant Monitoring Rule (UCMR4)
EPA also working on Third Six-Year Review, review of fluoride MCL, and review of Stage 2 DBPR/LT2ESWTR
CCL3 – 116 Contaminants
• Final CCL3 in October 2009
• CCL3 contains 104 chemicals and 12
microbial contaminants
• Research needs table shows that more
occurrence data is needed than health
effects
– Opposite of commonly held belief
RD3/CCL3 Stakeholder Meeting
• EPA presented occurrence data for 32 chemicals at June, 2011 stakeholder meeting
• Final RD3 in 2015 (?) (> 5 yrs. after RD2 in 2008)
– Preliminary RD3 just pre-published on 10/17
• Five nitrosamines
• Chlorate and three metals
• TCP, MTBE, PFOS, PFOA
• Potential negative determinations for 9 chemicals
– Another 8 acetanilides & degradates could be added to the negative determinations
Third Regulatory Determination• EPA is required to make decisions (reg.
determinations) on at least 5 contaminants every 5 years– Decided not to regulate 20 contaminants in first two
• National drinking water regulation did not provide “meaningful opportunity for risk reduction” as required by SDWA
– “Off-cycle” positive determination for perchlorate in 2011
• EPA is under pressure to regulate “something”
• Positive regulatory determination for strontium
• Negative determination for 1,3-dinitrobenzene, Dimethoate, Terbufos, and Terbufos sulfonone
• Delayed action for now on Nitrosamines and chlorate• Nitrosamines is potentially the most problematic
Chlorate and Strontium
• Chlorate – HRL of 210 µg/L (non-cancer)– ICR data from 1997-1998
• Finished water: Hypo – 22/59 (37%) plants >HRL– Chlorine dioxide – 15/29 (52%) plants >HRL
– Initial UCMR3 data – 37% PWSs >HRL• Averages: OSG-100 µg/L, hypolchlorite-175 µg/L
– Likely would be an issue for systems using chlorine dioxide and hypochlorite
• AWWA’s hypochlorite tool helps manage
• Strontium – HRL of 4,200 µg/L (non-cancer)– NIRS: 23/989 (2.33%) systems >HRL
– Initial UCMR3 data – 1.1% PWSs > HRL
Nitrosamines• Nitrosamines meet the first two of the three
SDWA criteria for regulating a new contaminant– NDMA and other nitrosamines are carcinogens
– NDMA and other nitrosamines occur (UCMR 2 data)
• Meeting the third criteria is debatable– Drinking water contribution is small
• Larger contribution from food and from what is produced inside the body (endogenous)
• Drinking water contribution is less than 0.1%
• EPA is under pressure to regulate “something”
• The preliminary third regulatory determination has been substantially delayed
Draft CCL4
• EPA doesn’t have the resources for an
effort comparable to CCL3 development
– Solicited CCL4 nominations in 2012
• How big should CCL4 be?
– Too many – too big of a research agenda
– Too few – not scanning the universe
• Not a simple question to answer
• Draft CCL4 in late 2014
Optimal Fluoride Level
• Jan. 2011-HHS proposed recommended level
of fluoride at low end (0.7 mg/L) of existing
range (0.7-1.2 mg/L)
– Variability of pumps, etc., need to be taken into
account
• Final level to be released in late 2014 (?)– Lots of delays
• EPA has initiated a review of MCL/SMCL
– Review is going slowly
LCR Long-Term Revisions
• This rule impacts all systems
• 1991 - Lead and Copper Rule (LCR)– Water systems learned a lot about site selection, sampling,
and optimized corrosion control
• 2007 – Short Term Revisions– Addressed some (but not all) sampling issues and
compliance determinations
• 2012 – CDC lowers recommended blood lead level for children– Based on a relative percentile as opposed to a fixed
health-based number
LCR-LTR Issues
• LCR Long-Term Revisions will likely address– Partial Lead Service Line Replacement (LSLR)
• Control versus ownership
• Potential supply of filters to households with partial LSLR
– Optimized corrosion control and water quality parameters
– Changes in sample site selection criteria
– Changes in sampling protocol• Systems with LSLs may have to collect LSL water sample
– Flushing interval would depend on LSL length
– Tap sampling & sampling protocol issues
LCR-LTR Dialogue
• With all of the issues, EPA has organized a
stakeholder approach to discuss potential
recommendations
– Broad range of issues being addressed
• Workgroup under the National Drinking
Water Advisory Council (NDWAC)
– Develop recommendations for EPA
• Dialogue started in March 2014
– Dialogue will last through early to mid-2015
Perchlorate• Perchlorate has been on CCL1, CCL2, CCL3
• 1999 – UCMR1 included perchlorate– Detected in 4% (160) of 3,865 systems
• 2005 – NAS Report– Established Reference Dose (RfD)
• 2008 – Proposed regulatory determination – not regulate
• 2009 – Supplemental request for comments– Asked for comments on “life-stages” & data extrapolation
– Also established interim health advisory for cleanups at 15 ppb
• 2011 – Final regulatory determination reversed proposed– Proposed regulation supposed to be released in Feb., 2013
– Unable to meet this deadline due to review by SAB Perchlorate Advisory Panel
Perchlorate (cont).• SAB Perchlorate Advisory Panel provided advice
for setting MCLG– “Life-stages” approach
– PBPK model shows 2% variation in iodine uptake
– Report was completed in May 2013
• Additional EPA analyses to incorporate SAB advice
• Potential precedents with perchlorate– The above issues plus the use of an “effect” versus an
“adverse effect”
– Cost-benefit debatable based on occurrence & cost
• Proposal has slipped until 2015– Final will likely be 12-18 months afterwards
Carcinogenic VOCs (cVOCs)
• Feb. 2, 2011 – EPA Administrator Jackson announced Carcinogenic VOCs (cVOCs) as the first group to be regulated
– Proposal has slipped until 2015(?)• Final rule in 2017 or beyond
– Eight currently regulated VOCs were identified, as well as eight VOCs from the Third Contaminant Candidate List (CCL3)
• The list on potentially included cVOCs is in flux
Potential cVOC Rule
• Second six-year review (2010)
– MCLs for TCE and PCE should be revised
– Zero MCLG and improved analytical method drove EPA analysis of MCLs of 1 ppb or 0.5 ppb
• EPA’s analysis of potential MCLs of 0.5 ppb concluded that approximately 400 (?) systems would be impacted
• Lower TCE/PCE MCLs would likely remove some of the eight unregulated CCL3 VOCs
– TCP is the biggest concern amongst the eight unregulated CCL3 VOCs
Potential cVOC Rule Issues
• TCP will likely be the driver for this rule due to its highest cancer slope factor (i.e., the biggest cancer risk)– Occurrence is LOT less than originally anticipated
• What would be the benefits?
• EPA is considering a “risk cup” or “total risk” regulatory framework– EPA would set a risk “target”
– Compliance would likely be based on the mix of VOCs in your source/finished water
• A new regulatory framework
– Treatment technologies would be air stripping and/or GAC
– Challenging framework
Proposed UCMR4
• June 25th stakeholder meeting
– EPA working on methods for several CCL3
chemicals & microbes
– Other potential UCMR4 issues
• Sampling during “vulnerable time period”
• Monitoring timeframe reduced from 2 to 3 years
• Appropriate sampling locations
• Collecting laboratory QA/QC data
• Inclusion and framing of UCMR4 data in CCRs
UCMR4 Schedule
• Proposal – mid 2015
• Final – late 2016
• Implementation starts in 2017
• Monitoring starts in January, 2018
2015 and Beyond
Cyclical
• Second round of
LT2 monitoring
(2015)
• Third Six-Year
Review (2016)
• Final UCMR4
(late 2016)
Contaminant-specific
• Fluoride
• Hexavalent
chromium (Cr-6)
• Acrylamide and
epichlorohydrin (?)
• Stage 3 DBPR (?)
Emerging Issues
• Naegleria fowleri
• Cyanotoxins
• Premise (interior) plumbing
– Legionella pneumophila
• Other chemicals
– Pharmaceuticals and personal care products
– Endocrine disruptors• Who knows what might be next?
Climate Change
• Third National Climate Assessment
released on May 6th
• Renewed focus within the Administration
– Greenhouse gases regulation proposal
• Carbon capture and storage (CCS) and
hydraulic fracturing
• Some connection with sustainability
Adam CarpenterRegulatory AnalystEmail: [email protected]: (202) 326-6126
American Water Works AssociationGovernment Affairs Office 1300 Eye Street, NW, Suite 701WWashington DC 20005Gen. Office: (202) 628-8303
Questions?