Status Update on Federal Consideration

of Hexavalent Chromium

Presented at

California Nevada American Water Works Association

Sacramento, CA

October 2, 2013

History• July 18, 2003 - First Six-Year Review,

no action awaiting Cr(VI) NTP study completion

• May 16, 2007 – NTP Study released

• August 20, 2009 – Draft CA OEHHA PHG (0.06 ug/L)

• March 29, 2010 - Second Six-Year Review, no action awaiting Cr(VI) risk assessment completion

• Sept 30, 2010 - IRIS Peer-Review Draft Toxicological Review of Hexavalent Chromium

• December 19, 2010 - EWG Report Chromium-6 in U.S. Tap Water

• December 22, 2010 - Administrator Jackson announced decision based on IRIS Cr(VI) assessment

• December 31, 2010 – Revised Draft CA OEHHA PHG (0.04 ug/L)

• January 11, 2011 - Pete Silva Memorandum, Enhanced Monitoring for Cr(VI)

• March 3, 2011 – Proposed UCMR3 request for comment on monitoring.

• April 26, 2011 – AB 403 (CA Cr-VI MCL by Jan 2013 or MCL=PHG) passes committee vote

• July 29, 2011 – Revised Draft CA OEHHA PHG (0.02 ug/L)

• September, 2011 – IRIS schedule shows new six-month delay (subsequently schedule dropped)

• May 2, 2012 – Final UCMR3 with Cr monitoring provisions

• August 25, 2013 – CDPH proposes Cr(VI) MCL

• September, 19 and 25, 2013 – IRIS webcasts

… The Administrator shall, … determines that— (i) the contaminant may have an adverse effect on the health of persons;

(ii) … known to occur or there is a substantial likelihood that the contaminant will occur …

(iii) …presents a meaningful opportunity for health risk reduction …

…Use of science in decision making.

… shall ensure … presentation of information on public health effects is comprehensive, informative, and understandable. …

(C) Health risk reduction and cost analysis.— …

(II) Quantifiable and nonquantifiablehealth risk reduction benefits for which there is an actual basis in the rulemaking record …

(III) Quantifiable and nonquantifiable costs for which there is a factual basis in the rulemaking record

… analysis of the health risk reduction benefits and costs likely to be experienced as the result of compliance with the treatment technique and alternative treatment techniques that are being considered, …

Safe Drinking Water Act – Key Criteria

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)

Federal SDWA Standard Setting Process

“… may have an adverse effect on

the health of persons …”

The NRC Risk Assessment Paradigm

Hazardidentification

Dose-responseassessment

Riskcharacterization

Exposureassessment

RiskManagement

decisions

Other economicand social factors

Controloptions

Legalconsiderations

Source: EPA Office of Research and Development.

Sources of Health Effect Analysis

• Integrated Risk Information System (ORD, NCEA)– Hazard identification and dose-

response

– Responding to concerns• Lack of productivity

• Lack of transparency

• Excessive conservatism

• Office of Science and Technology– Support to rulemaking activity

– Risk assessment

Agency-wide Application

(CAA, CERCLA, CWA, RCRA, SDWA)

Office of Water(CWA and SDWA)

Developing IRIS Health Assessments

Source: http://epa.gov/iris/pdfs/IRIS_PROCESS_FLOW_CHART.PDF, July 2013.

Developing Assessments

Source: http://epa.gov/iris/pdfs/irisprocesstimeline2013.pdf, July 2013.

Step ActivityTimeframe (months)

Standard Complex

1 IRIS draft assessment completed 10.5 15

2 Internal agency review 3 3

3 Interagency science consultation 2 3

4 Public comment and external peer review 5 9.5

5 Draft assessment revised 2 4

6a Internal agency review 2 3

6b Interagency science discussion

7 Final IRIS assessment 1.5 1.5

Total 26 39

“… substantial likelihood that the

contaminant will occur …”

Wholesale system (>10,000 served)

(Produces water)

Purchasing system

(>10,000 served)

(purchased only)

Purchasing system

(>10,000 served)

(also produces water)

Purchasing system

(>10,000 served)

(purchased only)

Purchasing system

(>10,000 served)

(also produces water)

Purchasing system

(<10,000 served)

(if in statistical sample of small systems)

Third Unregulated Contaminant Monitoring Rule

Stand-alone system

(<10,000 served)

(if in statistical sample of small systems)

Stand-alone system

(>10,000 served)

(also produces water)

Third Unregulated Contaminant Monitoring Rule

• National occurrence

– Collects data from roughly 6,300 systems

• Analytical methods

– Known quality

– Low-level quantitation

– Qualified laboratories

– Appropriate QA/QC

• Cr(VI) and total chromium

– Point-of-entry(ies) and maximum detention observations

• Collection takes time

– Jan 2013 – Dec 2015

– Data processing into 2016

“… analysis of the health risk

reduction benefits and costs likely

to be experienced …”

Health Risk Reduction and Cost Analysis

• National benefit

• National cost

• Community-level impacts

• Per household impact

• Small system variances

• Affordability

Inputs Occurrence Risk assessment (by

life stage) Relative source

contribution Available treatment

technology Risk management

alternatives Administrative costs Small business

impacts

“…Use of science {and

consideration of legal and social

factors} …”

Formal opportunity for input provided.

Input may be accepted but agency staff must document interaction for the public record;

in practice input at these points is discouraged.

OGWDW

drafts rule

EPA may or may not solicit

advice

Intra-agency review

Senior EPA management

approval

OMB and inter-agency

review

OGWDW revises as necessary

Senior EPA management

approval

Published proposal in

Federal Register for

comment with supporting

record.

Input from EPA / State

Working Group

Internal Review and Consultation,

(OGC, OPEI, office management, etc.)

Final iteration is sometimes called red-border review.

Administrative Process - Proposal

Formal opportunity for input provided.

Input may be accepted but agency staff must document interaction for the

public record; in practice input at these points is discouraged.

Administrative Process – Final Rule

OGWDW

revises rule

Comments and additional data / analysis

Intra-agency review

Senior EPA management

approval

OMB and inter-agency

review

OGWDW revises as necessary

Senior EPA management

approval

Publish final rule in Federal Register with

supporting record; now including a

comment response document.

Input from EPA / State

Working Group

Internal Review and Consultation,

(OGC, OPEI, office management, etc.)

Now open to lawsuit for 60 days

Final iteration is sometimes called red-border review.

Possible Federal MCL Timelines

20162014 2022

Final Rule(2 years)

IRIS ToxSummary

NOTE : SDWA provides 3 years to come into compliance with a new standard and 2 additional years for capital improvements (if approved by state)

UCMR3 Monitoring(1/2013 – 12/2015)

2018 2020 2024 2026

Six-Year 3 (12/2015)*

]

Proposal(2 years)

Final Rule(2 years)

Proposal(2 years)

Administrator’s Discretion

Implementation(3 years)

Capital Imp.(2 years)

Implementation(3 years)

Capital Imp.(2 years)

Reg Det 3 Final(<9/2014)1

Assuming USEPA proceeds to rulemaking.]

Questions?

Contact Information:

Steve Via

American Water Works Association

1300 Eye Street, NW, Suite 701W

Washington, DC 20005

p. (202) 326-6130

e. svia@awwa.org