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Bruce A. Macler, Ph.D.

USEPA Region 9
(415) 972-3569
macler.bruce@epa.gov
 
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Ë Rule promulgated January 22, 2001
± FR 66, #14, pp 6975-7066
± Effective date February 22, 2002
Ë MCL proposed at 5 ug/L, set at 10 ug/L
± Based on cost-benefit balance
± Used bladder and lung cancer risks
Ë 5-year implementation period
± MCL compliance January 23, 2006
± CCR reporting beginning February 22, 2002
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Ë Ariginal Public Health Service standard was
50 ug/L
± Based on non-cancer endpoints
Ë PHS standard grandfathered as EPA
Maximum Contaminant Level in 1974
Ë 1986 Safe Drinking Water Act amendments
directed EPA to review, revise arsenic MCL
± Concern for skin cancer
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Ë Maximum Contaminant Level Goals
± Not enforceable, but direct MCL
± "Each MCLG...shall be set at the level at which no known
or anticipated adverse effects on the health of persons occur
and which allow an adequate margin of safety"
Ë National Primary Drinking Water Regulations
± Enforceable
± Set as close as feasible to MCLGs
± Feasible analytical methods and treatment technologies
± Administrator can adjust MCL for cost reasons
Ë Ather regulatory applications generally not considered
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Ë For contaminants with no threshold for adverse
effects (i.e., initiator carcinogens)
± MCLG = zero as default or positive data for initiation
± MCL generally set between 1/10,000 and 1/million increased
lifetime risk for cancer, based on risk assessments
Ë For contaminants showing a threshold for adverse
effects (promoter carcinogens, non-carcinogens)
± MCLG based on Reference Dose (RfD), set to be below any
known adverse health effects
± MCL set as close as feasible to MCLG
 
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Ë Arsenic health effects have been extensively studied
Ë A variety of human cancers are associated with
arsenic ingestion
± Lung, bladder, prostate, skin, liver«
± Arsenic inhibits chromosomal repair, enhances cancer
progression
Ë Circulatory and neurological damage, diabetes also
can occur
± Arsenic inhibits mitochondrial respiration
Ë High disease levels seen in populations drinking
water with arsenic 5-20 times higher than current 50
ug/L MCL

 
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Ë We don¶t lack health data«
± 100¶s of arsenic publications in last two years
Ë Arsenic appears to act as endocrine disrupter to
block glucocorticoid action
± May affect diabetes, hypertension, cancer
± Acts as low as 10 ug/L
Ë Dimethylarsinic acid is toxic
± Causes DNA strand breaks in lung tissue (complete
carcinogen)
± Promotes bladder, kidney, liver and thyroid cancers
± Methylation NA a detoxification mechanism
 
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Ë Money
Ë Affected drinking water purveyors
Ë Ather affected parties
Ë Health effects/ regulatory benefits
Ë reatment
 


 

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Ë U59,000 community water systems in US
± U10,000 use surface water, U49,000 use ground
water
± About 2500 utilities serve >10,000 people
± >90% of smallest systems use groundwater
Ë Highestarsenic levels are in small
groundwater systems
± 3300 GW systems, 90 SW systems >10 ug/L
± 3300 small (<10,000), 90 large
 


 

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Ë Most affected systems are very small, rural
Ë Smaller systems not really utilities
± Few have a full-time operator
± Little or no treatment infrastructure
± Limited financial resources
Ë Most affected systems have had few
regulations to follow up to now
Ë Basically, implementation starts from scratch
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Ë Drinking water MCLs used for Superfund and
other hazardous waste cleanups
± While not directly applicable, these are considered
³relevant and appropriate regulations´
± Groundwater cleanups may be set at MCL
Ë Mine wastes, oil extraction brines, coal flyash
often high in arsenic
± Arsenic may be dominant risk in site assessments
Ë Cleanup costs are less important
± Costs could be greater than for all drinking water
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Ë is arsenic a public health problem in the US?
± SDWA goals versus risk perceptions
± Safety is in the eye of the beholder
Ë SDWA has 
 public health risk goal
± MCLs have been set with estimated risks between
1/10,000 - 1/million excess lifetime
± Not law, but precedent
Ë here are no ³bodies in the streets´ in U.S. from
arsenic
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Ë Epidemiology, medicine can at best resolve risks
>1/100 level
± For arsenic, exposures not high enough for
epidemiology to find disease in U.S.
Ë Risk assessments can extrapolate data to lower
exposures and risk levels
± Regulatory risk assessments are conservative, generally
go to upper risk boundaries
Ë Arsenic has always been here, so some
biochemical detoxification mechanism must exist
± Real risks could be lower
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Ë For smaller GW systems, going from
nothing to something
Ë For larger GW systems, wellhead treatment
at multiple wells
Ë Waste disposal hassles and costs
Ë Peripherals: land, permits, human
resources, NiMBYs, etc
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Ë in early 1990¶s, new cancer concerns were growing
Ë But strong opposition by oil, extractive and drinking
water industries
Ë 1996 SDWA amendments featured arsenic, cost-
benefit decision-making
Ë EPA proposed 5 ug/L as arsenic MCL in June 2000
Ë EPA promulgated MCL at 10 ug/L in January 2001
Ë New Administration postponed effective date, set
up review
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Ë EPA Administrator Whitman said, ³it's only a
review. he MCL may stay the same or even go
down.´
Ë National Academy of Sciences reviewed health
data and risk assessments from 3-20 ug/L
Ë National Drinking Water Advisory Committee
reviewed cost and technologies materials
Ë EPA Science Advisory Board reviewed benefits
analysis
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Ë he Academy¶s National Research Council
reviewed EPA¶s arsenic risk assessment
± Reviewed use of aiwanese studies and
aiwanese populations
± Evaluated data for 1% (ED01) cancer risk level
± Considered EPA¶s analysis of mode of action
and dose-response uncertainties
± Judged whether EPA risk estimates for 3, 5, 10
and 20 ug/L were consistent with current science
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Ë Data from aiwan, Chile indicate high risks for
cancer
± Appropriate for risk assessment use
± Utah study too problematic for use
Ë Use linear approach to extrapolate from 1% (ED01)
cancer risk to 1/10,000 regulatory risk level
± Sublinear extrapolation not justified
± Substantial variation in human response needs to be
incorporated
± Consider using U.S. background cancer levels
Ë Epidemiological studies unlikely to show effects in
U.S.
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Ë NAS estimated arsenic-associated lung and
bladder cancers
± Bladder cancer risk about 12-23/10,000 @ 10 ug/L
± Lung cancer risk about 14-18/10,000 @ 10 ug/L
± (EPA had estimated bladder + lung cancer at 0.6-
3/10,000 @ 10 ug/L)
Ë Athercancers not quantified, but add risk
Ë Averall 1% cancer risk level < 50 ug/L
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Ë Science Advisory Board examined how EPA valued
benefits from Arsenic Rule
± Reviewed quantification of cancer costs, and benefits from
not getting cancer
± Also reviewed quantification of costs of other diseases
Ë Recommended EPA quantify ischemic heart disease,
diabetes mellitus and skin cancer
Ë Suggested EPA consider quantifying prostate cancer,
nephritis, nephrosis, hypertension, hypertensive heart
disease and non-malignant respiratory disease
Ë Said EPA should consider latency adjustment
Ë Net result could increase or decrease benefits of Rule
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Ë Examined costing methodologies,
assumptions, information and national
estimate of system costs for the Arsenic Rule
Ë Concluded that EPA¶s estimate was credible
Ë Affered a variety of improvements
± New technologies will lower costs
± Necessary related activities add to costs
± Net result unlikely to significantly change national
costs

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2 3 !!!%%&*+4
u
 Proposed Proposed ³What if´  

 Cost Benefits Benefits 


 $645-756 $44-104 $42-448 

 $379-445 $32-90 $35-384 
 $165-195 $18-52 $20-224 
 $63-77 $8-30 $9-128 
Costs and benefits in $M/yr
Also, unquantified health benefits for cancers of the skin, kidney, nasal
passages, liver, and prostate and noncancer effects on the cardiovascular,
immune, nervous, and glandular systems likely to be substantial
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Ë EPA let MCL stand at 10 ug/L without
comment on reviews
Ë implementation by small systems will be a
challenge
± Need simple, user-friendly treatment
± Must be easy to design, ³off-the-shelf´ to cut costs
± Need to find and train operators
± Need money
± Need to change some minds