Regulatory & Related 

Updates

National Drinking Water Advisory Council

November 17, 2015

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Regulatory Analysis, Rule Development, and 

Stakeholder Support

• Contaminant Candidate List

• Unregulated Contaminant Monitoring Rule

• Regulatory Determination

• Rule Development/Revision

– Perchlorate

– Reduction of Lead

– cVOCs Group

• Six Year Review of Regulations

• Stakeholder Support/Guidance

– Cyanotoxins

– Legionella

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General Flow of SDWA Regulatory Processes

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

of supporting data used (e.g. health, occurrence, treatment). 

Draft CCL

Final CCL

Final Rule 

(NPDWR)

Six Year Review of 

Existing NPDWRs

No further action if make 

decision 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

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Regulatory Analysis: 

Contaminant Candidate List (CCL) 

• Published draft CCL 4 - Feb 4, 2015 

– 60-day comment period ended April 6

– Lists 100 chemicals or chemical groups and 12 microbial contaminants 

– CCL 4 info at- http://www2.epa.gov/cct/draft-contaminant-candidatelist-4-ccl-4

•Next Steps -

– Compile, consider, and analyze public comments

– Revise CCL 4, as appropriate

– Publish Final CCL in 2016

• Background –

– Published CCL 3 – October 2009

– Requested public to nominate contaminants for CCL 4 – May 2012

4
Third Unregulated Contaminant 

Monitoring Rule (UCMR 3)

• Proposal published March 3, 2011

• Final rule published May 2, 2012

• Monitoring is occurring from 2013-15

• 28 chemicals and 2 viruses

• Contaminants include hormones, perfluorinated compounds 

(e.g., PFOS/PFOA), VOCs, metals (including Cr+6 and total Cr), 

1,4-dioxane, chlorate and pathogens

• Data are posted to the National Contaminant Occurrence 

Database (NCOD) 

(water.epa.gov/lawsregs/rulesregs/sdwa/ucmr/data.cfm) 

• Will complete monitoring in 2015 and data reporting in 2016 5
UCMR 3 – Contaminants

• Pharmaceuticals (EPA Method 539)

– 17-α-ethynylestradiol

– 17-β-estradiol

– equilin

– estriol

– estrone

– testosterone

– 4-androstene-3,17-dione

• Metals (EPA Method 200.8)

– cobalt

– molybdenum

– strontium

– vanadium

– (total) chromium

•EPA Method 218.7

-hexavalent chromium

• Volatile Organic Compounds (EPA Method 524.3)

- 1,1-dichloroethane

- 1,2,3-trichloropropane

- 1,3-butadiene

- bromochloromethane

- chlorodifluoromethane

- chloromethane

- methyl bromide

• EPA Method 522

-1,4-dioxane

• EPA Method 300.1

-chlorate

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UCMR 3 – Contaminants (cont.)

• Microbials

– 2 viruses

• enterovirus (qPCR & cell culture)

• norovirus (qPCR)

– “Indicator organisms”

• Total coliform

• E. coli

• enterococci

• coliphage

• aerobic spores

• Perfluorinated Chemicals (EPA Method 537)

– Perfluorooctane sulfonate (PFOS)

– Perfluorooctanonic acid (PFOA)

– Perfluoroheptanoic acid (PFHpA)

– Perfluorononanoic acid (PFNA)

– Perfluorobutane sulfonic acid (PFBS)

– Perfluorohexane sulfonic acid (PFHxS)

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Future Plans for UCMR -- UCMR 4

1. Develop and publish the proposed UCMR 4 Rule in late 

2015.

2. Hold a UCMR 4 stakeholder webinar during the public 

comment period.

3. Develop and publish the final UCMR 4 Rule by January 

2017.

4. Anticipated monitoring period Jan 2018 thru Dec 2020.

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Regulatory Analysis:

Regulatory Determinations 

SDWA requires EPA to make regulatory 

determinations for at least 5 CCL contaminants 

every 5 years. EPA must regulate if:

2) The contaminant is known to occur or there is 

substantial likelihood that the contaminant will occur in 

public water systems with a frequency and at levels of 

public health concern; and

1) The contaminant may have an adverse effect on the 

health of persons;

3) In the sole judgment of the Administrator, regulation of such 

contaminant presents a meaningful opportunity for health risk reduction 

for persons served by public water systems

*SDWA Section 1412(b)(1) 9

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Status and Next Steps for 

Regulatory Determinations 3 (RD 3)

• On October 20, 2014, published the preliminary RD 3 FR notice 

for public comment. 

– The FR notice contained the following preliminary determinations:

• 4 negatives: 1,3-Dinitrobenzene, Dimethoate, Terbufos, and Terbufos Sulfone

• 1 positive: Strontium

• On December 9, 2014, held a public meeting/webinar to solicit 

input on:

– The process to identify, and the information used to evaluate CCL 3 

contaminants to make preliminary determinations; and 

– The 5 preliminary determinations

• Public comment period closed on December 19, 2014.

• Expect to publish the final RD 3 in early 2016.

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Rule Development: Perchlorate

• Developing a proposed perchlorate standard

– Evaluating available data on perchlorate occurrence 

– Evaluating the feasibility of treatment technologies to remove 

perchlorate

– Examining the costs and benefits of potential standards

• Following up on SAB recommendations (made in May 2013) for 

methodologies to derive a MCLG

– Expect to develop a perchlorate MCLG using Physiologically Based 

Pharmacokinetic (PBPK) modeling

– Working with FDA scientists to develop a PBPK model consistent 

with SAB recommendations to derive a perchlorate MCLG

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2011 Reduction of Lead in Drinking Water Act

• The RLDWA was enacted on January 4, 2011 to amend Section 1417 

of the SDWA respecting the use and introduction into commerce of 

lead pipes, plumbing fittings or fixtures, solder and flux. 

• The effective date was January 4, 2014. 

• In 2013, EPA published a summary of the RLDWA requirements and 

some answers to frequently asked questions related to the 

amendments to assist manufacturers, retailers, plumbers and 

consumers in understanding the changes to the law 

(http://water.epa.gov/drink/info/lead/upload/epa815s13003.pdf)

• EPA initiated an action to codify the lead free requirements in the 

RLDWA.

• EPA plans to propose regulations in mid-2016

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Rule Development: 

Carcinogenic Volatile Organic Compounds (cVOCs) Group

EPA is developing a proposed group cVOC standard 

• Considering regulated (tetrachloroethylene (PCE), trichloroethylene 

(TCE), and others) and unregulated carcinogenic VOCs (cVOCs)

• Occurrence data are being collected for 3 unregulated cVOCs 

currently under UCMR 3, which concludes in Dec 2015. Plan to 

wait until UCMR 3 monitoring is complete to proceed with rule 

development to consider new occurrence data. 

• Presented approaches for a group MCL construct to the NDWAC in fall 

2014.

• Examining the feasibility of analytical methods and treatment 

technologies.

• Any revision for currently regulated cVOCs will improve or maintain 

health protection 13
Regulatory Analysis: Six Year Review 

• EPA must review existing National Primary Drinking Water 

Regulations (NPDWRs) every six years and, if appropriate, revise

Background 

• Completed the 1st Six Year Review of 69 NPDWRs (2003); made 

decision to revise TCR

• Completed the 2nd Six Year Review of 71 NPDWRs (2010) and 

identified PCE, TCE, acrylamide and epichlorohydrin as candidates for 

revision

– Status

• Will complete the 3rd Six Year Review in 2016 - this will be the first 

time a Six Year Review addresses the microbial and disinfection 

byproduct regulations 

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Stakeholder Support: Cyanotoxins

• Public meeting/webinar: May 11, 2015

o Purpose: To obtain additional information the Agency can provide to 

states and public water systems to help them prepare for and respond to 

potential cyanotoxin health concerns in drinking water

o Approximately 500 attendees (online and in person)

• June 17, 2015 EPA publications:

o Health Advisories

• Microcystins

• Cylindrospermopsin

o Health Effects Support Documents

• Microcystins

• Cylindrospermopsin

• Anatoxin-a

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Stakeholder Support: Cyanotoxins (cont.)

• On June 17, EPA also published a supporting document to assist in 

managing risks from cyanotoxins: Recommendations for Public 

Water Systems to Manage Cyanotoxins in Drinking Water

– Purpose: 

o To provide information to public water systems (PWSs), state and local 

authorities, and other stakeholders to assist with the management of 

cyanotoxins that occur in drinking water 

o To encourage PWSs and primacy agencies to coordinate and prepare for 

harmful algal blooms, and develop a response focusing on 

communication, monitoring, and treatment

o The document serves as a companion to the EPA Health Advisories (HA) 

for microcystins and cylindrospermopsin. 

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Stakeholder Support: Cyanotoxins (cont.)

• On August 7, 2015, P.L. 114-45 was signed into law, 

amending the Safe Drinking Water Act by adding Section 

1459 for Algal Toxin Risk Assessment and Management

• Section 1459 directs the EPA to submit to Congress a 

strategic plan for assessing and managing risks associated 

with algal toxins in drinking water provided by public 

water systems 

• EPA solicited stakeholder input on September 16, 2015 

which has been very helpful in developing the plan

• EPA is currently developing the strategic plan and intends 

to submit it to Congress in November 2015 17
Stakeholder Support:

Legionella Treatment Technology Document

• Purpose: 

o To characterize the effectiveness of treatment technologies to 

control for Legionella based on findings from peer reviewed 

literature 

• Audience:

o States and primacy agencies, affected facilities and system 

operators

• Authors:

o A multi-agency taskforce has been participating in the data compilation

• EPA, CDC, ASDWA, state primacy agencies

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Next Steps in Development of the 

Legionella Treatment Technology 

Document

• Publish draft document – October 21, 2015

• Public meeting/webinar – November 9, 2015

• Independent external peer review – late 2015/early 2016

• Publish final document – 2016

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