815-Z-00-006
Thursday,
December 7, 2000
Part H
Environmental
Protection Agency
40 CFR Parts 9, 141, and 142
National Primary Drinking Water
Regulations; Radionuclides; Final Rule
Note to Reader: Hand edits were made to correct typographical errors in this document. A
corrections notice will be published in the Federal Register. In addition, there was a computer
problem translating the symbol for micrograms Cug/L) in several places in this document. The
Maximum Contaminant Level for Uranium should be cited throughout the document as 30 //g/L.'
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76708 Federal Register/Vol. 65, No. 236/Thursday, December 7, 2000/Rules and Regulations
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Parts 9,141, and 142
[FRLr-6909-3]
RIN 2040-AC98
National Primary Drinking Water
Regulations; Radionuclides; Final Rule
AGENCY: Environmental Protection
Agency.
ACTION: Final rule.
SUMMARY: Today, EPA is finalizing
maximum contaminant level goals
(MCLGs), maximum contaminant levels
(MCLs), and monitoring, reporting, and
public notification requirements for
radionuclides. Today's rule is only
applicable to community water systems.
Today's rule includes requirements for
uranium, which is not currently
regulated, and revisions to the
monitoring requirements for combined
radium-226 andradium-228, gross alpha
particle radioactivity, and beta particle
and photon radioactivity. Based on an
improved understanding of the risks
associated with radionuclides in
drinking \vater, the current MCL for
combined radium-226/-228 and the
current MCL for gross alpha particle
radioactivity will be retained. Based on
the need for further evaluation of the
various risk management issues
associated with the MCL for beta
particle and photon radioactivity and
the flexibility to review and modify
standards under the Safe Drinking
Water Act (SDWA), the current MCL for
beta particle and photon radioactivity
will be retained in this final rule, but
will be further reviewed in the near
future.
Some parts of EPA's 1991 proposal,
including the addition of MCLGs and
the National Primary Drinking Water
Regulation (NPDWR) for uranium, are
required under the SDWA. Other
portions were intended to make the
radionuclides NPDWRs more consistent
with other NPDWRs, e.g., revisions to
monitoring frequencies and the point of
compliance. Lastly, some portions were
contingent upon 1991 risk analyses, e.g.,
MCL revisions to the 1976 MCLs for
combined radium-226 and -228, gross
alpha particle radioactivity, and beta
particle and photon radioactivity. The
portions required under SDWA and the
portions intended to make the
radionuclides NPDWRs more consistent
with other NPDWRs are being finalized
today. The portions contingent upon the
outdated risk analyses supporting the
1991 proposal are not being finalized
today, in part based on updated risk
analyses.
DATES: This regulation is effective
December 8, 2003. The incorporation by
reference of the publications listed in
today's rule is approved by the Director
of the Federal Register as of December
8, 2003. For judicial review purposes,
this final rule is promulgated as of 1
p.m. Eastern Time on December 7, 2000.
ADDRESSES: The record for this
regulation has been established under
the docket name: National Primary
Drinking Water Regulations for
Radionuclides (W-00-12). The record
includes public comments, applicable
Federal Register notices, other major
supporting documents, and a copy of
the index to the public docket. The
record is available for inspection from 9
a.m. to 4 p.m., Eastern Standard Time,
Monday through Friday, excluding
Federal holidays, at the Water Docket,
401 M Street SW, East Tower Basement
[Room EB 57), Washington, DC 20460.
For access to the Docket materials,
please call (202) 260-3027 to schedule
an appointment.
FOR FURTHER INFORMATION CONTACT: For
technical inquiries, contact David
Huber, Standards and Risk Management
Division, Office of Ground Water and
Drinking Water, EPA (MC-4607), 1200
Pennsylvania Avenue, NW.,
Washington, DC 20460; telephone (202)
260-9566. For general inquiries, the
Safe Drinking Water Hotline is open
Monday through Friday, excluding
Federal holidays, from 9:00 a.m. to 5:30
p.m. Eastern Standard Time. The Safe
Drinking Water Hotline toll free number
is (800) 426-4791.
SUPPLEMENTARY INFORMATION:
Regulated Entities
Entities potentially regulated by this
rule are public water systems that are
classified as community water systems
(CWSs). Community water systems
provide water for human consumption
through pipes or other constructed
conveyances to at least 15 service
connections or serve an average of at
least 25 people year-round. Regulated
categories and entities include:
be regulated. To determine whether
your facility is regulated by this action,
you should carefully examine the
applicability criteria in
Category
Industry
State, Tribal, Local,
and Federal Gov-
ernments.
Examples of
regulated entities
Privately-owned com-
munity water sys-
tems.
Publicly-owned com-
munity water sys-
tems.
This table is not intended to be
exhaustive, but rather, provides a guide
for readers regarding entities likely to be
regulated by this action. Other types of
entities not listed in the table could also
141.26(b)(l), and 141.26(b)(2) of this
rule. If you have questions regarding the
applicability of this action to a
particular entity, consult the person
listed in the preceding FOR FURTHER
INFORMATION CONTACT section.
Abbreviations and Acronyms Used in
This Document
ASTM: American Society for Testing and
Materials
AWWA: American Water Works Association
BAT: Best available treatment
BEIR: Biological effects of ionizing radiation
CFR: Code of Federal Regulations
CWS: Community water systems
EDE: Effective dose equivalent
EML: Environmental Measurements
Laboratory
FR: Federal Register
ICRP: International Commission on
Radiological Protection
IE: Ion exchange
kg: Kilogram
L/day: Liter per day
LET: Low energy transfer
LOAEL: Lowest observed adverse effect level
MCL: Maximum contaminant level
MCLG: Maximum contaminant level goal
mg/L: Milligram per liter
ug/L: Microgram per liter
mGy: MilliGray
mrem: Millirem
mrem/yr: Millirem per year
NBS: National Bureau of Standards
NDWAC: National Drinking Water Advisory
Committee
NIRS: National Inorganic and Radionuclide
Survey
NIST: National Institute of Standards and
Technology
NODA: Notice of Data Availability
NPDWRs: National Primary Drinking Water
Regulations
NRC: National Research Council
NTIS: National Technical Information
Service
NTNC: Non-transient, non-community
NTNCWS: Non-transient, non-community
water systems
pCi: Picocurie
pCi/L: Picocurie per liter
PE: Performance evaluation
PNR: Public Notification Rule
POE: Point-of-entry
POU: Point-of-use
PQL: Practical quantitation level
PT: Performance testing
RADRISK: A computer code for radiation risk
estimation
R£D: Reference dose
RO: Reverse osmosis
SM: Standard methods
SMF: Standardized monitoring framework
SSCTL: "Small Systems Compliance
Technology List"
SWTR: Surface Water Treatment Rule
TAW: Technical Advisory Workgroup
UCMR: Unregulated Contaminant Monitoring
Rule
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Federal Register/Vol. 65, No. 236/Thursday, December 7, 2000/Rules and Regulations 76709
UNSCEAR: United Nations Scientific
Committee on the Effects of Atomic
Radiation
USDOE: United States Department of Energy
USEPA: United States Environmental
Protection Agency
USGS: United States Geological Survey
Table of Contents
I. Background and Summary of the Final
Rule
A. What did EPA propose in 1991?
B. Why did EPA propose changes to the
radionuclides drinking water regulations
in 1991?
C. What new information has become
available since 1991? Overview of the
2000 Notice of Data Availability (NODA).
D. What are the rationales for the
regulatory decisions being promulgated
today?
• 1. Retaining the Combined Radium-226
and Radium-228 MCL
a. Major Comments Regarding Retention of
the Combined Radium-226 and Radium-
228 MCL
2. The Final Uranium MCL
a. What is the final MCL for uranium and
the rationale for that regulatory level?
b. MCLG and Feasible Level for Uranium
c. Basis for 1991 Proposed MCL and Cancer
Risk from Uranium
d. Uranium Health Effects: Kidney Toxicity
e. New Kidney Toxicity Analyses
Announced in the NODA
f. Costs and Benefits from Regulating
Uranium in Drinking Water
g. Administrator's Decision to Promulgate
MCL Higher than Feasible Level
h. California Drinking Water Regulation
i. Summary of Major Comments on the
Uranium Options
(1) Costs and Benefits of Uranium MCLs of
20, 40, and 80 ug/L or pCi/L
[2) The Calculation of the Safe Level for
Uranium in Water
(3) Compliance Options for Small Systems
for an MCL of 20 ug/L or pCi/L
(4) The Use of a Dual Standard for
Uranium
3. Retaining Beta Particle and Photon
Radioactivity MCL
a. Summary of Major Comments Regarding
the Decision to Retain the Current Beta
Particle and Photon Radioactivity MCL
4. Retaining the Current Gross Alpha
Particle Activity MCL .
a. Summary of Major Comments Regarding
the Decision to Retain the Current
Definition of the (Adjusted) Gross Alpha
Particle Activity MCL
5. Further Study of Radium-224
a. Summary of Major Comments on
Radium-224
(1) The Use of a Short Gross Alpha Particle
Activity Sample Holding Time to
Measure Radium-224
(2) The Need to Regulate Radium-224
. 6. Entry Point Monitoring and the
Standardized Monitoring Framework
7. Separate Monitoring for Radium-228 and
Change to Systems Required to Monitor
for Beta Particle and Photon
Radioactivity
. 8. Future Actions Regarding the Regulation
of Radionuclides at Non-Transient Non-
Community Water Systems
a. Summary of Major Comments on
NTNCWSs and EPA Responses
E. What are the health effects that may
result from exposure to radionuclides in
drinking water?
1. Major Comments
a. Linear Non-threshold Model
b. Radium Carcinogenicity Threshold
c. "Beneficial Effects" of Radiation
F. Does this regulation apply to my water
system?
G. What are the final drinking water
regulatory standards for radionuclides
(Maximum Contaminant Level Goals and
Maximum Contaminant Levels)?
H. What are the best available technologies
(BATs) for removing radionuclides from
drinking water?
I. What analytical methods are approved
for compliance monitoring of
radionuclides?
1. Major Comments
a. Request for ICP-MS Method for Uranium
b. Detection Limit for Uranium
J. Where and how often must a water
system test for radionuclides?
1. Monitoring frequency for gross alpha,
radium 226, radium 228, and uranium:
2. Monitoring frequency for beta particle
and photon radioactivity:
3. Sampling points and data grandfathering
4. Does the rule allow compositing of
samples?
5. Interpretation of Analytical Results
K. Can my water system use point-of-use
. (POU), point-of-entry (FOE), or bottled
water to comply with this regulation?
L. What do I need to tell my customers?
1. Consumer Confidence Reports
2. Public Notification
M. Can my water system get a variance or
an exemption from an MCL under
today's rule?
N. How were stakeholders involved in the
development of this rule?
O. What financial assistance is available for
complying with this rule?
P. How are the radionuclides MCLs used
under the Comprehensive Environmental
Response, Compensation, and Liability
Act (CERCLA)?
Q. What is the effective date and
compliance date for the rule?
R. Has EPA considered laboratory
approval/certification and laboratory
capacity?
1. Laboratory Approval/Certification
2. Laboratory Capacity: Laboratory
Certification and PT Studies
3. Summary of Major Comments Regarding
Laboratory Capacity and EPA Responses
a. Laboratory Certification, Availability of
PT Samples and Costs of PT Samples:
b. Laboratory Capacity:
II. Statutory Authority and Regulatory
Background
A. What is the legal authority for' setting
National Primary Drinking Water
Regulations (NPDWRs)?
B. Is EPA required to finalize the 1991
radionuclides proposal?
III. Rule Implementation
A. What are the requirements for primacy?
B. What are the special primacy
requirements?
C. What are the requirements for record
keeping?
D. What are the requirements for reporting?
E. When does a State have to apply for
primacy? ,
F. What are Tribes required to do under
this regulation?
IV. Economic Analyses
A. Estimates of Costs and Benefits for
- Community Water Systems .-
B. Background
1. Overview of the 1991 Economic
Analysis
2. Summary of the Current Estimates of
Risk Reductions, Benefits, and Costs
3. Uncertainties in the Estimates of
Benefits and Cost
a. Uncertainties in Risk Reduction and
Benefits Estimates
b. Uncertainty in Compliance Cost
Estimates
4. Major.Comments
a. Retention of radium-226/-228 MCL of 5
pCi/L
b. Cost/Benefit Analysis Requirements
c. Cumulative Affordability
d. Disposal costs
e. Discounting of Costs and Benefits
f. Use of MCLs for Ground Water
Protection Needs to be Evaluated as Part
of this Rulemaking
V. Other Required Analyses and
Consultations
A. Regulatory Flexibility Act (RFA)
B. Paperwork Reduction Act
C. Unfunded Mandates Reform Act
1. Summary of UMRA Requirements
D. National Technology Transfer and
Advancement Act
E. Executive Order 12866: Regulatory
Planning and Review
F. Executive Order 12898: Environmental
Justice
G. Executive Order 13045: Protection of
Children from Environmental Health
Risks and Safety Risks
H. Executive Order 13084: Consultation
and Coordination with Indian Tribal
Governments
I. Executive Order 13132
J. Consultation with the Science Advisory
Board and the National Drinking Water
Advisory Council
K. Congressional Review Act
I. Background and Summary of the
Final Rule
A. What Did EPA Propose in 1991?
In 1991, EPA proposed a number of
changes and additions to the
radionuclides NPDWRs. Among other
things, EPA proposed to:
• Set a maximum contaminant level
goal (MCLG) of zero for all
radionuclides.
• Set a maximum contaminant level
(MCL) of 20 ng/L or 30 pCi/L for
uranium (with options of 5 pCi/L to 80
Hg/U
• Change the radium standard from a
combined limit for radium-226 and 228
of 5 pCi/L to separate standards at 20
pCi/L. .,
• Remove radium-226 from the
radionuclides included in the definition
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76710 Federal Register /Vol. 65, No. 236/Thursday, December 7, 2000/Rules and Regulations
of gross alpha, while keeping the gross
alpha MCL at 15 pCi/L, since the
proposed radium-226 MCL was greater
than the gross alpha MCL.
• Change dose limit from critical
organ dose (millirems) to "weighted
whole body dose" (mUlirems-effective
dose equivalent).
• Require community water systems
which are determined by the State to be
vulnerable or contaminated to monitor
for beta particle and photon
radioactivity, rather than at all surface
water systems serving a population over
100,000 people (as under the current
1976 rule).
• Establish a monitoring framework
more in line with the standardized
monitoring framework used for other
contaminants.
• Exclude compositing for beta
particle and photon emitters.
• Include non-transient, non-
community water systems (NTNCWSs)
in the regulation.
• Require that each entry point to the
distribution system be monitored to
ensure that each household in the
system received water protective at the
MCL.
B. Why Did EPA Propose Changes to the
Radionuclides Drinking Water
Regulations in 1991?
In 1976, National Interim Primary
Drinking Water Regulations were
promulgated for radium-226 and -228,
gross alpha particle radioactivity and
beta particle and photon radioactivity.
The health risk basis for the 1976
radionuclides MCLs was described in
the recent radionuclides Notice of Data
Availability (NODA), (65 FR 21575,
April 21,2000). The 1986
reauthorization of the Safe Drinking
Water Act (SOWA) required EPA to
promulgate MCLGs and National
Primary Drinking Water Regulations
(NPDWRs) for the above radionuclides,
radon and uranium. Also in 1986, EPA
published an Advance Notice of
Proposed Rulemaking for the
radionuclides NPDWRs (EPA 1986),
which stated EPA's intent to accomplish
this goal. In 1991, EPA proposed
changes to the current radionuclides
standards and new standards for radon
and uranium. EPA determined that both
combined radium-226 and -228 and
uranium could be analytically
quantified and treated to 5 pC£/L.
However, EPA concluded that, given the
much greater cost-effectiveness of
reducing risk through radon water
treatment relative to radium and
uranium, the feasible levels were 20
pCi/L each for radium-226 and -228 and
20 ug/L (or 30 pCi/L) for uranium.
Between 1986 and 1991, EPA made risk
estimates based on then-current models
and information, as described in the
NODA (EPA 2000e) and its Technical
Support Document (USEPA 2000h). The
1991 risk estimates1 indicated that the
proposed MCL changes would result in
lifetime cancer risks within the risk
range of 10"* and 10~4 (one in one
million to one in ten thousand) that EPA
considers in establishing NPDWRs. The
1991 proposed uranium MCL was based
on both'kidney toxicity risk and cancer
risk. All MCLGs for radionuclides were
proposed as zero pCi/L, based on a
linear no-threshold cancer risk model
for ionizing radiation. A summary of the
difference between the 1976 rule and
the 1991 proposal are presented in
Table 1-1. The detailed differences
between the 1976 rule and the 1991
proposal can be found in the record for
this rulemaking (EPA 1976; 1986; 1991;
2000a).
TABLE 1-1.—COMPARISON OF THE 1976 RULE. 1991 PROPOSAL, AND 2000 FINAL RULE
Provision
1976 rule (current rule)
1991 proposal
2000 final rule
Affected Systems ....
MCLG for all radio-
nuclides.
Radium MCL .....
Beta/Photon Radio-
activity MCL.
Gross alpha MCL ...
Polonium-210
Lead-210
Uranium MCL .
CWS
No MCLG
CWS + NTNC .
MCLG of zero .
Combined Ra-226 + Ra-228 MCL of
5pCi/L.
• £4 mrem/y to the total body or-any
given internal organ
• Except for H-3 and Sr-90, derived
radionucide-specific activity con-
centrations yielding 4 mrem/y based
on NSB Handbood 69 and 2L/d
• H-3 = 20,000 pCi/L; Sr-90 = 8 pCi/L
. Total dose from co-occurring beta/
photon emitters must be £ 4 mrem/y
to the total body of any internal
organ
15 pCi/L excluding U and Rn. but in-
cluding Ra-226.
Induded in gross alpha
Ra-226 MCL of 20 pCi/L
Ra-228 MCL of 20 pCi/L
« 4 mrem/y effective dose equivalent
(ede)
• Re-derived radionuclide-specific ac-
tivity concentrations yielding 4
mrem/y ede based on EPA
RADRISK code and 2 Ud
• Total dose from co-occurring beta/
photon emitters must be < 4 mrem/y
ede
"Adjusted" gross aplha MCL of 15 pCi/
L. excluding Ra-226, radon, and ura-
nium.
Included in gross alpha
Not Regulated
Not Regulated
Included in beta partide and photon
radioactivity: concentration limit pro-
posed at 1 pCVL.
20j4*/t.or 30 pCi/L w/ option for 5 pCi/
csw.
MCLG of zero.
Maintain current MCL based on the
newly estimated risk level associ-
ated with the 1991 proposed MCL.
Maintain current MCL based on the
newly estimated risk level associ-
ated with the 1991 proposed MCL.
This MCL will be reviewed within 2
to 3 years based on a need for fur-
ther re-evaluation of risk manage-
ment issues.
Maintain current MCL based on the
newly estimated risk level associ-
ated with the 1991 proposed MCL.
Included under gross alpha, as in cur-
rent rule. Monitoring required under
, the UCMR ru\e. Further action may
be proposed at a later date.
No changes to current rule. Monitoring
required under the UCMR rule. Fur-
ther action may be proposed at a
later date.
30
"The taat cancer risk estimates were based on
«ho now-OMtdatcd RADRISK model (see the NODA
and its Technical Support Document. USEPA 2000e
and h).
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Federal Register/Vol. 65, No. 236/Thursday, December 7, 2000/Rules and Regulations 76711
TABLE 1-1.—COMPARISON OF THE 1976 RULE, 1991 PROPOSAL, AND 2000 FINAL RULE—Continued
Provision
1976 rule (current rule)
1991 proposal
2000 final rule
Ra-224
Radium monitoring .
Monitoring baseline
Beta particle and
photon emitters
monitoring.
Gross alpha moni-
toring.
Analytical Methods
I
Part of gross alpha, but sample hold-
ing time too long to capture Ra-224.
Ra-226 linked to Ra-228; measure Ra-
228 if Ra-226 > 3 pCi/L and sum.
4 quarterly measurements ..—
Monitoring reduction based on results:
> 50% of MCL required 4 samples
every 4 yrs; < 50% of MCL reguired
1 sample every 4 yrs
Surface water systems > 100,000 pop-
ulation Screen at 50 pCi/U; vulner-
able systems screen at 15 pCi/L.
Analyze up to one year later
Provide methods
Part of gross alpha, but sample hold-
ing time too long to capture Ra-224.
Measure Ra-226 and -228 separately
Annual samples for 3 years; Std Moni-
toring Framework: > 50% of MCL re-
quired 1 sample every 3 years; <
50% of MCL enabled system to
apply for waiver to 1 sample every 9
years.
Ground and surface water systems
within 15 miles of source screen at
30 or 50 pCi/t.
Six month holding time for gross alpha
samples; Annual compositing of
samples allowed.
Method updates proposed in 1991;
Current methods were updated in
1997.
No changes to current gross alpha
rule. Will collect national occurrence
information; further action may be
proposed at a later date.
Measure Ra-226 and -228 separately.
Implement Std Monitoring Framework
as proposed in 1991. Four initial
consecutive quarterly samples in
first cycle. If initial average level >
50% of MCL: 1 sample every 3
years; < 50% of MCL: 1 sample
every 6 years; Non-detect: 1 sample
•-• every 9 years, (beta particle and
| photon radioactivity has a unique
schedule—see section III, part—K)
-States will have discretion in data
grandfathering for establishing initial
monitoring baseline.
CWSs determined to be vulnerable by
the State screen at 50 pCi/L.
As proposed in 1991.
Current methods with clarifications.
C. What New Information Has Become
Available Since 1991? Overview of the
2000 Notice of Data Availability
(NODA)
EPA published a Notice of Data
Availability (NODA) on April 21, 2000.
This NODA described the new
information that has become available
since the 1991 proposal and the basis
for today's final regulatory decisions.
The most significant source of new
information is Federal Guidance Report-
13 (FGR-13) (USEPA 1999b), "Cancer
Risk Coefficients for Environmental
Exposure to Radionuclides," which
provides the numerical factors used in
estimating cancer risks from low-level
exposures to radionuclides. The risk
coefficients in FGR-13 are based on
state-of-the-art methods and models and
are a significant improvement over the
risk coefficients that supported the 1991
radionuclides proposal. FGR-13 is the
latest report in a series of Federal
guidance documents that are intended
to provide Federal and State agencies
technical information to assist their
implementation of radiation protection
programs. FGR-13 was formally
reviewed by EPA's Science Advisory
Board and was peer-reviewed by
academic and government radiation
experts. An interim version of the report
was published for public comment in
January of 1998. Comments were
provided by Federal Agencies,
including the Nuclear Regulatory
Commission and the Department of
Energy, State Agencies, and the public.
The final version (September 1999)
reflects consideration of all of these
comments. The risk analyses supporting
today's regulatory decisions are
described in detail in the NODA (EPA
2000e) and its Technical Support
Document (USEPA 2000h).
The NODA also reported the results
from a June 1998 USEPA workshop held
to discuss non-cancer toxicity issues
associated with exposure to uranium
from drinking water. At this workshop,
a panel of experts reviewed and
evaluated new information regarding
kidney toxicity was examined. The
findings from this workshop can be
found in the NODA's Technical Support
Document (USEPA 2000h).
Other important new information
includes the results from a 1998 U.S.
Geological Survey study which targeted
the occurrence of radium-224 and beta
particle/photon radioactivity (USEPA
2000e and h). Previously, it was
assumed that the alpha-emitting
radium-224 isotope rarely occurred in
drinking water. If present in drinking
water, because of its short half-life (3.6
days) and estimated low occurrence, it
was thought that sufficient time would
elapse to allow the isotope to decay to
low levels before entry into the
distribution system. Hence, radium-224
was not thought to appreciably occur in
drinking water. This new information
indicates that radium-224 significantly
(positively) correlates with both radium-
228 (correlation coefficient of 0.82) and
radium-226 (correlation coefficient of
0.69), suggesting that radium-224
should be evaluated as a potential
drinking water contaminant of national
concern (USEPA 2000h). The impact of
this and other information on decisions
regarding radium-224 is discussed in
part D of this section. In addition to the
radium-224 occurrence information, the
USGS study also determined that the
majority of the beta particle/photon
radioactivity in the samples collected
was due to the presence of radium-228
and potassium-40, both naturally
occurring contaminants. Since radium-
228 is regulated under the combined
radium-226/-228 standard and
potassium-40 is not regulated, this ..
suggests that most situations in which
the beta/photon screening level is
exceeded will not result in MCL
violations. Of more concern, minor
contributions from naturally occurring
lead-210 were also reported. Lead-210
occurrence will be studied under the
Unregulated Contaminant Monitoring
Rule(UCMR).
In addition to this new technical
information, the NODA also described
the 1996 changes to the statutory
framework for setting drinking water
NPDWRs. The SDVVA. as amended in
1996, requires EPA to review and revise,
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76712 Federal Register/Vol. 65, No. 236/Thursday, December 7, 2000/Rules and Regulations
as appropriate, each national drinking
water regulation at least once every six
years. The Act also requires that any
revision to an NPDWR "maintain, or
provide for greater, protection of the
health of persons" (section 1412(b)(9)).
Regarding the setting of new
NPDWRs, the SDWA as amended in
1996 gives EPA the flexibility to set an
MCL at a level less stringent than the
feasible level, if the Administrator
determines that the benefits do not
justify the costs at the feasible level. If
the Administrator makes this finding,
the Act directs EPA to set the MCL at
a level that "maximizes health risk
reduction benefits at a cost that is
justified by the benefits" (section
1412(b)(6)J. This provision applies to
uranium only, since it is the only
contaminant for which a new MCL is
being established by today's regulatory
action.
D. What Are the Rationales for the
Regulatory Decisions Being Promulgated
Today?
As previously discussed, EPA is
retaining the current MCLs for
combined radium-226 and 228, gross
alpha particle radioactivity, and beta
particle and photon radioactivity and is
promulgating a new standard for
uranium. The following is a discussion
of the rationales supporting these
decisions. In addition to the responses
to major comments in the following
section, responses to each individual
comment are in the comment response
document which is available for review
in the docket for this final rule.
1. Retaining the Combined Radium-226
and Radium-228 MCL
The 1991 proposed changes to the
MCLs for combined radium-226 and
radium-228 were premised on a cost-
effectiveness trade-off between radium
mitigation and radon mitigation (a
radon standard was also included in the
1991 proposal). This cost-effectiveness
argument was used to support a
proposal to raise the combined radium-
2267-228 MCL of 5 pCi/L to individual
MCLs of 20 pCi/L for each isotope. At
the time, it was thought that the risks
associated wjth 20 pCi/L of radium-226
and radium-228 were within the 10~6 to
10—' risk range. However, current risk
analyses based on Federal Guidance
Report-13 (see Part C of this section)
indicate that these higher MCLs have
associated risks that are well above the
10~* to lO"4 risk range. For details on
the basis and findings of this risk
analysis, see the NODA (USEPA 2000e)
and its Technical Support Document
(USEPA 2000h). Since this proposed
change would introduce higher risks
than envisioned in the original 1976
rule, approaching lifetime cancer risks
of one in one thousand (10 ~3) for
occurrence at or near the 1991 proposed
MCLs, EPA believes that its decision to
retain the current combined radium-
226/-22S MCL of 5 pCi/L is justified.
Under the 1996 Amendments to the Safe
Drinking Water Act, EPA is required to
ensure that any revision to a drinking
water regulation maintains or provides
for greater protection of the health of
persons (section 1412(b)(9)).
a. Major Comments Regarding Retention
of the Combined Radium-226 and
Radium-228 MCL
The major comments and responses
concerning the retention of the
combined radium-226 and radium-228
MCL are summarized in part E of this
section ("What are the health effects
that may result from exposure to
radionuclides in drinking water?").
2. The Final Uranium MCL
a. What Is the Final MCL for Uranium
and the Rationale for That Regulatory
Level?
With today's rule, EPA is
promulgating a uranium MCL of 30 jig/
L. The SDWA generally requires that
EPA set the MCL for each contaminant
as close as feasible to the MCLG, based
on available technology and taking costs
to large systems into account. The 1996
amendments to the SDWA added the
requirement that the Administrator
determine whether or not the
quantifiable and non-quantifiable
benefits of an MCL justify the
quantifiable and non-quantifiable costs
based on the Health Risk Reduction and
Cost Analysis (HRRCA) required under
section 1412(b)(3)(C). The 1996 SDWA
amendments also provided new
discretionary authority for the
Administrator to set an MCL that is less
stringent than the feasible level if the
benefits of an MCL set at the feasible
level would not justify the costs (section
1412(b)(6)). This final rule establishing
an MCL for uranium of 30 |ig/L is the
first time EPA has invoked this new
authority.
In conducting this analysis, EPA
considered all available scientific
information concerning the health
effects of uranium, including various
uncertainties in the interpretation of the
results, as well as all costs and benefits,
both quantifiable and non-quantifiable.
As discussed in more detail below, all
health endpoints of concern were
considered in this analysis. For some of
these, the risk can currently be
quantified (i.e., expressed in numerical
terms); and for some, it cannot.
Similarly, there are a variety of health
and other benefits attributable to
reductions in levels of uranium in
drinking water, some of which can be
monetized (i.e., expressed in monetary
terms) and others that cannot yet be
monetized. All were considered in this
analysis. A detailed discussion of each
of the principal factors considered
follows.
b. MCLG and Feasible Level for
Uranium
Since uranium is radioactive and EPA
uses a non-threshold linear risk model
for ionizing radiation, today's rule sets
the MCLG (non-enforceable health-
based goal) for this contaminant at zero.
The Safe" Drinking Water Act requires
EPA to set the MCL as close to the .
MCLG as is feasible, where this is
defined as "feasible with the use of the
best technology, treatment techniques
and other means which the
Administrator finds, after examination
for efficacy under field conditions and
not solely under laboratory conditions,
are available (taking cost into
consideration) * * * " [section
1412(b)(4)(D)]. EPA proposed a feasible
level of 20 |ig/L in its 1991 proposal. In
doing so, EPA determined that uranium
may be treatable and quantifiable at
levels below 20 ng/L, however, levels
below 20 p.g/L were not considered
feasible under the Safe Drinking Water
Act. EPA believes the feasible level is
still 20 ng/L.
c. Basis for 1991 Proposed MCL and
Cancer Risk from Uranium
EPA is required by the Safe Drinking
Water Act (section 1412(b)(2)) to
regulate uranium in drinking water. In
1991, EPA proposed a uranium MCL of
20 ng/L ("mass concentration") based
on health effects endpoints of kidney
toxicity and carcinogenicity. In the
proposal, EPA estimated that 20 ng/L
would typically2 correspond to 30 pCi/
L ("activity"), based on an assumed
mass:activity ratio of 1.5 pCi/p.g. While
such values are known to occur in
ground water, this conversion factor
.does not reflect our "best estimate"
today. The best estimate of a geometric
average mass:activity ratio is 0.9 pCi/ng
for values near the MCL, based on data
from the National Inorganics and
Radionuclides Survey (see USEPA
2000h). Given the closeness of this
2 The actual relationship between mass
concentration (ng/L) and activity (pCi/L) varies
somewhat in drinking water sources, since tho
relative amounts of the radioactive isotopes that
make up naturally occurring uranium (U-238, U-
235, and U-234) vary between drinking water
sources. The typical conversion factors that arc
observed in drinking water range from 0.67 up to
1.5 pCi/ng.
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Federal Register/Vol. 65, No. 236/Thursday, December 7, 2000/Rules and Regulations 76713
value to unity (1 pCi/ug), the available
data suggests that, to a first
approximation3, themassractivity ratio
is 1:1 for typical systems. The 1991
proposed MCL of 20 ug/L was
determined, at that time, to correspond
to a "drinking water equivalent level"
(DWEL4) with respect to kidney toxicity
for a lifetime exposure. The
corresponding 30 pCi/L level (based on
the 1991 mass to activity conversion)
was estimated to have a lifetime cancer
risk of slightly below the 10 ~4 level.
Because the kidney toxicity health
effects and the corresponding non-
quantifiable kidney toxicity benefits are
a very important consideration in
setting the MCL, we first provide
background on these effects before
discussing the rationale for setting the
uranium MCL.
d. Uranium Health Effects: Kidney
Toxicity
Each kidney consists of over a million
nephrons, the filtration functional units
of the kidney. The nephron consists of
glomeruli, which filter the blood, and
renal tubules (proximal, distal,
collecting duct, etc.), which collect the
fluid that passes through the glomeruli
(the "filtrate"). After the filtrate flows
into renal tubules, glucose, proteins,
sodium, water, amino acids, and other
essential substances are reabsorbed,
while wastes and some fraction of
electrolytes are left behind for later
excretion. The efficiency of this process
can be monitored by analyzing urine
("urinalysis"), •which reveals the
concentrations of the various
constituents making up the urine. For
example, protein or albumin in the
urine (proteinuria or albuminuria)
indicates reabsorption deficiency or
leakage of albumin, a class of proteins
found in blood and which are
responsible for maintaining fluid
balance between blood and body cells.
In the case of uranium toxicity, it is not
clear whether long-term exposure may
lead to marked albumin loss.
The level of proteinuria in urine is an
indication of the degree of kidney
toxicity: levels are divided into "trace",
"mild", "moderate", or "marked",
which are defined by increasing levels
of proteinuria. Increased excretion of
3 This is mentioned since, for the sake of
simplicity, the reader may thus easily convert
between ug/L and pCi/L. However, in current
calculations, we use the geometric mean from the
NIRS data, which is 0.9 pCi/ ug. We reiterate that
conversion factors ranging from 0.67 up to 1.5 pCi/
ug do occur in drinking water sources.-
4Tho drinking water equivalent level (DWEL) ( ug/
L) is the best estimate of the drinking water
concentration that results in the Reference Dose ( ug/
kg/day), assuming a water irigestion rate of 2 L/day
and a body mass of 70 kg.
protein in the urine could be the result
of tubular damage, inflammation, or
increased glomerular permeability. It
should be noted that a gradual loss of
. nephrons is asymptomatic until the loss
is well advanced; the kidneys normally
have the ability to compensate for.
nephron-loss. For example, chronic
renal failure occurs when there is
around 60% nephron loss. During the
gradual loss of functioning nephrons,
the remaining nephrons appear to adapt,
increasing their capacity for filtration,
reafasorption, and excretion.
Uranium has been identified as a
nephrotoxic metal (kidney toxicant),
exerting its toxic effects by chemical
action mostly in the proximal tubules in
humans and animals. However,
uranium is a less potent nephrotoxin
than the classical nephrotoxic metals
such as cadmium, lead, and mercury.
Uranium has an affinity for renal
proximal tubular cells and interferes
with reabsorption of proteins, as
previously described. Specifically,
uranium-induced renal tubular
dysfunction in humans is marked by
mild proteinuria, due to reduced
reabsorption in the proximal renal
tubules. Furthermore, the pathogenesis
of the kidney damage in short-term
animal studies indicates that
regeneration of the tubular cells may
occur upon discontinuation of exposure
to uranium. We do not know if
uranium-induced proteinuria is an
indicator of the beginning of an adverse
effect or whether it is a reversible effect
that does not typically result in kidney
disease. Based on the uncertainty
involved in the ultimate effects, the
scientists at our experts workshop
(discussed next) treated this effect as an
indicator of an incipient change in
kidney function that may lead
ultimately to frank adverse effects such
as breakdown of kidney tubular
function. For general information on
proteinuria, kidney function, and
kidney disease, see the fact sheets at
"http://www.niddk.nih.gov/health/
kidney/pubs/ proteinuria/
proteinuria.htm", "http://
www.niddk.nih.gov/health/kidney/
pubs/yourkids/index.htm", and "http://
www.niddk.nih.gov/health/kidney/
kidney .htm" (NIH 2000a, NIH 2000b,
and NIH 2000c).
e. New Kidney Toxicity Analyses
Announced in the NODA
Since the 1991 radionuclides
proposal, EPA has re-evaluated the
available kidney toxicity data and,
based on the results of an experts
workshop (see the NODA, USEPA
2000e, for details), has estimated the
DWEL to be 20 ug/L. The DWEL is
derived from the Reference Dose (RfD),
which is an estimate of a daily ingestion
exposure to the population, including
sensitive subgroups, that is likely to be
•without an appreciable risk of
deleterious effects during a lifetime. The
RfD (in ug of uranium per kg of body
mass per day; ug/kg/day) for uranium
was calculated from the Lowest
Observed Adverse Effects Level
("LOAEL"), which is the lowest level at
which adverse effects were observed to
occur. The LOAEL is taken directly from
health effects data. The RfD is
calculated by dividing the LOAEL by a
numerical uncertainty factor which
accounts for areas of variability in
human populations because of
uncertainty in the uranium health
database. EPA followed the
recommended methodology of the
National Academy of Sciences in
estimating the uncertainty factor.
As described in the NODA, we
reported that our best-estimate of the
LOAEL is 60 ug/kg/day, based on rat
data. In support of this estimate of the
DWEL, EPA has some human data
which demonstrates that mild
proteinuria has been observed at
drinking water levels between 20 and
100 ug/L. In estimating the RfD, we have
used an uncertainty factor of 100
(rounded from the product of 3 for intra-
species variability, 10 for inter-species
variability, and 3 for the use of a
LOAEL). Using this uncertainty factor,
the RfD is calculated to be 0.6 ug/kg/
day. The estimated uncertainty in the
RfD spans an order of magnitude (a
factor often). The 20 ng/L DWEL is
calculated by using this RfD and
assuming that an adult with a body
mass of 70 kilograms drinks 2 liters of
water per day 5 and that 80% of
exposure to uranium is from water.
These calculations are described in
more detail in the NODA's Technical
Support Document (USEPA 2000h).
The Agency believes that 30 ug/L is
protective against kidney toxicity. While
20 ug/L is the Agency's best estimate of
the DWEL, there are several reasons, in
the Agency's judgment, that
demonstrate that there is not a
predictable difference in health effects
due to exposure between the DWEL of
20 ug/L and a level of 30 ug/L. For
instance, variability in the normal range
for proteinuria in humans is very large
and there is additional variability in
proteinuria levels observed at uranium
5 The standard assumptions for the DWEL are
conservative, since the ingestion rate is at the 90th
percentile, while the body mass is more typical.
Conservative assumptions arc used to ensure that
the resulting exposure level is protective of
individuals that consume significantly more water
than typical and children (low body masses).
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76714 Federal Register/Vol. 65, No. 236/Thursday, December 7, 2000/Rules and Regulations
exposures large enough to induce the
effect. In the existing few epidemiology
studies, each of which are based on
small study populations, there were
some persons exposed to over five times
the DWEL of 20 ug/L without the
observation of effects more serious than
mild proteinuria (within the high end of
the normal range). An MCL of 30 ug/L
represents a relatively small increase
over the DWEL compared to the over-all
uncertainty in the RfD and the
uncertainty in the importance of the
mild proteinuria observed for uranium
exposures from high drinking water
levels (keeping in mind that, as
discussed previously, the DWEL is
based on the RfD and is an estimate of
a no effect level for a population). While
it is assumed that risk of an effect (here
a mild effect) increases as exposure
increases over the RfD, it is not known
at what exposure an effect is likely.
Given that the uncertainty factor of 100
provides a relatively wide margin of
safety, the likelihood of any significant
effect in the population at 30 ug/L is
very small. EPA, thus, believes that the
difference in kidney toxicity risk for
exposures at 20 ug/L versus 30 ug/L is
insignificant.
f. Costs and Benefits From Regulating
Uranium in Drinking Water
As discussed in the NODA, EPA has
estimated the risk reductions,
monetized benefits, and costs associated
with compliance with an MCL of 20 ug/
L, 40 ug/L, and 80 ug/L. In the NODA,
EPA solicited comment on using its
statutory authority provided in section
1412(b)(6) of the Safe Drinking Water
Act to set the uranium MCL at a level
higher than the proposed level of 20 ug/
L, based on its analysis of costs and
benefits.
The monetized costs and benefits
associated with various MCL options are
discussed further in section IV of
today's notice and in more detail in the
economic analysis support document
(USEPA 2000g). Table 1-2 shows
incremental annual cancer risk
reductions, total national annual
compliance costs and monetized
benefits (excluding kidney toxicity
benefits), and the numbers of
community water systems predicted to
have MCL violations for MCLs of 80, 30,
and 20 ug/L (assuming the 0.9 pCi/ug
conversion factor for estimating cancer
risk reductions and benefits). Keeping in
mind that the monetized benefits and
risk reductions exclude kidney toxicity
benefits, several things can be noted
from the analysis. Focusing on the MCL
change from 30 ug/L to 20 ug/L (see
lower part of table 1-2), one can see that
the incremental benefits for
implementing an MCL of 30 ug/L are
three times greater than the incremental
benefits for a lower MCL of 20 ug/L,
while the incremental annual costs are
much closer in magnitude ($54 million
vs. $39 million). In terms of incremental
cancer cases avoided, the estimated
number of cancer cases avoided for an
MCL of 30 ug/L is 0.8 annually, while
lowering the MCL to 20 ug/L would
result in an additional 0.2 cases avoided
annually (25% reduction) at an
additional cost of $39 million annually
(75% increase). Approximately 37% of
systems predicted to have MCL
violations occur between 30 ug/L and 20
ug/L, resulting in significant increases
in annual compliance costs (42% of
national compliance costs occur
between 30 ug/L and 20 ug/L), while the
number of cancer cases avoided
increases much less significantly (only
20% of cancer risk reduction occurs
between 30 ug/L and 20 ug/L).
Since the kidney benefits are not
quantified, this is an incomplete
picture, but EPA believes that the
uncertainties in the analysis of health
effects are such that it is not known
whether the risk of mild proteinuria are
appreciably different between 20 ug/L
and 30 ug/L. Assuming that there is a
risk increase, it would be expected to be
negligible compared to the risk increase
that occurs between the highest
uranium levels that occur in drinking
water (i.e., approximately 200 ug/L) and
an MCL of 30 ug/L. Considering only
cancer risk reduction benefits, the
annual net benefits 6 for a uranium MCL
of 20 ug/L are negative $90 million7 and
for an MCL of 30 ug/L are negative $50
million. Since the cancer risk reduction
net benefits are higher at 30 ug/L than
at 20 ug/L and the non-quantified
kidney toxicity benefits are expected to
be substantially the same at 20 ug/L and
30 ug/L, EPA believes an MCL of 30 ug/
L maximizes the benefits at a cost
justified by the benefits. EPA does not
believe that uranium levels above 30 ug/
L are protective of kidney toxicity with
an acceptable margin of safety. (EPA
believes that the margin of safety
associated with a 30 ug/L are
comparable with those at 20 ug/L.)
Further, EPA believes that the net
kidney toxicity benefits of an MCL
greater than 30 ug/L would be less than
those at 30 ug/L. Finally, EPA believes
that 30 ug/L is protective of the general
population, including children and the
elderly.
TABLE 1-2.—INCREMENTAL COSTS AND BENEFITS FOR URANIUM MCLs OF 80 UG/L, 30 UG/L, AND 20
Uranium MCL
20 ug/L
Exposure
change
~-80 ug/L
80-30 ug/L
30-20 ug/L
Incremental
annual cancer
cases avoided
0.5
0.4
0.2
Incremental
annual
compliance
costs
(in millions)
$16
38
39
Incremental
annual monetized
cancer benefits
(kidney benefits not
monetized)
(in millions)
$2
1
1
Incremental
number of
community water
systems
impacted
100
400
290
Incremental Costs and Benefits for Uranium MCLs of 30 ug/L (ug/L) and 20 u.g/L only
20 ug/L
~-30 ug/L
30-20 [ig/L
0.8
0.2
54
39
3
1
500
290
Note: Numbers are rounded, so numbers resulting from addition and subtraction of the numbers shown may appear to yield incongruous re-
sults. However, the numbers shown are calculated using more significant figures and rounded after, which is the appropriate approach for num-
bers with large uncertainties.
f-Not incremental net benefits, but not benefits:
"BenoSts for an MCL in isolation"—"Cost of an
MCL in isolation".
'Annual net benefits for an MCL of 20 ug/L = S4
million—S93 million, which rounds to negative S90
million; annual net benefits for an MCL of 30 ug/
L = S3 million—S54 million, which rounds to
negative S50 million. See Table IV-1, "Summary of
Costs and Benefits for Community Water Systems
Predicted to Be Impacted by the Regulatory Options
Being Considered for Finalization", in today's
notice and the supporting Economic Analysis
(USEPA 2QOOg) for more details.
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Federal Register/Vol. 65, No. 236/Thursday, December 7, 2000/Rules and Regulations 76715
g. Administrator's Decision To
Promulgate MCL Higher Than Feasible
Level
Based on the relatively modest annual
cancer risk reductions and the expected
modest kidney toxicity risk reductions
between 30 ug/L and 20 ug/L (see Table
1—2] and the high annual compliance
costs for an MCL of 20 ug/L, the
Administrator has determined that the
benefits do not justify the costs at the
feasible level. Furthermore, as
previously described, the Administrator
has determined that an MCL of 30 ug/
L maximizes the health risk reduction
benefits at a cost justified by the
benefits. In summary, this finding is
based on the fact that potential uranium
MCLs lower than 30 ug/L have
substantially higher associated
compliance costs and only modest
additional cancer risk reduction and
kidney toxicity benefits. EPA has not
selected a higher MCL for several
reasons. Higher uranium MCLs would
still incur implementation and
monitoring costs, •with benefits greatly
diminished because uranium does not
occur significantly at levels much
higher than 30 Ug/L. Additionally, EPA
believes that a uranium MCL of 30 ug/
. L is appropriate since it is protective of
kidney toxicity and cancer with an
adequate margin of safety. We do not
believe that MCL options higher than 30
ug/L afford a sufficient measure of
protection against kidney toxicity.
Assuming a conversion factor of 0.9
pCi/ug, an MCL of 30 ug/L will typically
correspond to 27 pCi/L, which has a
lifetime radiogenic cancer risk of
slightly less than one in ten thousand,
within the Agency's target risk range of
one in one million to one in ten
thousand. EPA is aware that
circumstances may exist in which more
extreme conversion factors (> 1.5 pCi/
Ug) apply. EPA does not have extensive
data on these ratios at local levels, but
believes these higher ratios to be rare. In
these rare circumstances, uranium
activities in drinking water may exceed
40 pCi/L. Although these concentrations
are still within EPA's target risk ceiling
of 1X10 ~ 4, EPA recommends that
drinking water systems subject to
extreme pCi/ug conversion factors
mitigate uranium levels to 30 pCi/L or
less, to provide greater assurance that
adequate protection from caricer health
effects is being afforded.
In today's final rule, the
Administrator is exercising her
authority to set an MCL at a level higher
than feasible (section 14l2(b)(6)), based
on the finding that benefits do not
justify the costs at the feasible level (20
Ug/L) and that the net benefits are
maximized at a level (30 ug/L) that is
still protective of kidney toxicity and
carcinogenicity with an adequate
margin of safety. EPA believes that there
are considerable non-quantifiable
benefits associated with ensuring that
kidney toxicity risks are minimized and
has weighed these non-quantifiable
benefits in its decision to exercise its
discretionary authority under SDWA
section 1412(b)(6).
In invoking the discretionary
authority of section 1412(b)(6) to set an
MCL level higher than feasible, the
Agency is in compliance with the
provisions of section 1412(b)(6)(B). This
provision provides that the judgment
with respect to when benefits of the
regulation would justify the costs under
subparagraph (6)(A) is to be made based
on assessment of costs and benefits
experienced by persons served by large
systems and those other systems
unlikely to receive small system
variances (e.g. systems serving up to
10,000 persons). In effect, the costs to
systems likely to receive a small system
variance are not to be considered in
judging the point at which benefits
justify costs. Subparagraph (6}(B) also
provides, however, that this adjusted
assessment does not apply in the case of
a contaminant found "almost
exclusively" in "small systems eligible"
for a small system variance. Because the
contaminants addressed in today's rule
are found almost exclusively in small
systems and because the Agency has
identified affordable treatment
technologies for small systems that
would need to comply with today's rule
(i.e., we do not contemplate granting
small system variances), the Agency has
not adjusted the proposed MCL
pursuant to subparagraph (B).
h. California Drinking Water Regulation
Approximately one-third of the
community water systems that are
expected to be impacted by the uranium
MCL are located in California. Thus,
current and likely future practices of
these systems is of particular interest.
The State of California currently has a
drinking water standard for uranium of
20 pCi/L (enforced as 35 Ug/L), which it
adopted in 1989. EPA has used
comments and information from the
State of California in considering its
MCL for uranium. The California
standard is based on the California
Department of Health Services' 1989
estimate of the DWEL for kidney
toxicity, 35 ug/L. While California has
recently proposed revising its non-
enforceable public health goal for
uranium in drinking water, it is not
currently known what the final estimate
will be. In response to the NODA,
representatives of the California
Department of Health Services
commented that at uranium levels of 35
Ug/L, most of its small water systems
were able to use alternate sources of
water (new wells) as a means of
complying with the standard, but that
20 ug/L would lead to many of these
small systems having to install
treatment, which, because of waste
disposal issues (i.e., inability to safely
dispose of hazardous radioactive
wastes), could lead to a significant
number of small systems being unable
to come into compliance through
' treatment. EPA believes that these
comments lend support to the choice of
an MCL of 30 ug/L as being both
protective of kidney toxicity and a
standard that allows for significant use
of non-treatment options by small
systems, reducing the need for dealing
with radioactive waste handling and
disposal.
i. Summary of Major Comments on the
Uranium Options
(1) Costs and Benefits of Uranium
MCLs of 20, 40, and ,80 ug/L or pCi/L:
Most commenters stated that the
benefits of an MCL of 20 ug/L or pCi/
L did not justify the costs and suggested
that EPA should exercise its authority
under SDWA section 1412(b)(6) to set
an MCL higher than the feasible level.
As discussed previously in this section,
EPA agrees that the benefits of an MCL
at 20 ug/L do not justify the costs and
has exercised its SDWA authority by
setting the uranium MCL at a level of 30
ug/L, a level at which EPA believes the
benefits do justify the costs.
(2) The Calculation of the Safe Level
for Uranium in Water: One commenter
suggested that the use of 70 kg as the
reference body mass with a "90th
percentile ingestionrate" of 2 L/day
will lead to a kidney toxicity DWEL that
is more protective than the 90th
percentile. EPA agrees that it is possible
that 20 ug/L is more protective than the
90th percentile value for the general
population. EPA has performed a
preliminary Monte Carlo analysis of the
safe level that replaces point estimates
for consumption rate and body mass
with distributions based on the
available data. Based on this analysis
the 90th percentile (for the general
population) equivalent level could be as
high as 30 Ug/L.
(3) Compliance Options for Small
Systems for an MCL of 20 ug/L or pCi/
L: Several commenters stated that an
MCL of 20 ug/L or pCi/L would force
small systems to install water treatment,
rather than allowing other compliance
options like installing new wells or
blending water. The commenters
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76716 Federal Register/Vol. 65, No. 236/Thursday, December 7, 2000/Rules and Regulations
suggested that an MCL of 20 ug/L or
pCi/L would pose a significant hardship
on small systems with little benefit,
including significant costs and technical
problems associated with waste
disposal. Commenters also suggested
that a higher MCL would allow a larger
fraction of small systems to use
compliance options other than
treatment, most notably, new well
installation. EPA agrees that a lower
MCL does decrease the probability that
some non-treatment options could be
used, including new well installation
and blending. EPA agrees that the
benefits of the MCL of 20 ug/L or pCi/
L do not justify the costs and thus has
chosen a higher MCL. EPA also believes
that an MCL of 30 ug/L should allow a
greater fraction of small systems to use
non-treatment options for compliance,
avoiding waste disposal issues and
excessive treatment costs.
(4) The Use of a Dual Standard for
Uranium: Commenters suggested that
the use of a dual standard for uranium
to ensure protectiveness of both kidney
toxicity and carcinogenicity, i.e., one in
ug/L and one in pCi/L, would be
unnecessarily complicated, since it
would require that both uranium
isotopic analyses and mass analyses be
performed by each water system. EPA
agrees that a dual standard would be
unnecessarily complicated and has
chosen a single standard expressed in
ug/L that is protective of both kidney
toxicity and carcinogenicity.
3. Retaining Beta Particle and Photon
Radioactivity MCL
With today's rule, EPA is retaining the
existing MCL for beta and photon
emitters and the methodology for
deriving concentration limits for
individual beta and photon emitters that
is incorporated by reference. The
concentrations for these contaminants
were derived from a dosimetry model
used at the time the rule was originally
promulgated in 1976. When these risks
are calculated in accordance with the
latest dosimetry models described in
Federal Guidance Report 13, the risks
associated with these concentrations,
while varying considerably, generally
fall within the Agency's current risk
target range for drinking water
contaminants of 10-" to 10 -«.
Accordingly, we are not changing the
MCL for beta particle and photon
radioactivity at this time.
We also are concerned that under the
regulatory changes for the beta particle
and photon radioactivity MCL proposed
in 1991") the concentrations of many
•4 rarcm ode with a look-up table of
concentrations different from those calculated using
individual radionuclides have
associated lifetime cancer morbidity
(and mortality) risks that exceed the
Agency's target risk range. A newly
proposed MCL expressed in mrem-ede
could result in a more consistent risk
level within the Agency's target risk
range. However, in today's final rule, we
are ratifying the current standard since
it is protective of public health. At the
same time, we believe a near future
review of the beta particle and photon
radioactivity MCL and the methods for
calculating individual radionuclide
concentration limits is appropriate. We
intend to reevaluate the MCL under the
authority of section 1412(b)(9) of the
SDWA to ensure that the MCL reflects
the best available science. This review
will be performed as expeditiously as
possible (expected to be 2 to 3 years).
Particular questions that we believe
warrant examination as part of such a
reevaluation process would include, but
are not limited to, the following:
• What additional beta and photon
emitters should be regulated?
• What is the appropriate aggregate
MCL expression for this category of
radionuclides?
• What new information concerning
occurrence, analytical methods, health
effects, treatment, costs, and benefits
would have a bearing on this
reevaluation?
• Is there an advantage to setting
individual radionuclide concentration
limits using a "uniform risk level
MCL"?
• If the basis of the current MCL
changes, is there an advantage.to and
legal basis for setting concentration
limits for individual beta particle and
photon emitters -within a guidance
document that can be readily updated as
scientific understanding improves?
• To what degree, in Keeping with the
provisions of sections 1412(b)(9) and
1412(b)(3)(A), can the existing
methodology for calculating the
concentration limits of individual beta
and photon emitters be adjusted in
accordance with the best available
scientific models and information and
still meet the requirement that revised
regulations provide "greater or
equivalent protection to the health of
persons"?
• How would any adjustments be
reconciled with the requirement that
MCLs be set "as close as feasible" to
MCLGs?
Finally, we note that there should be
no assumption, from the outset of this
reevaluation, that the process will
necessarily lead to a different set of
individual beta and photon emitter
concentration limits than those that
result from the methodology
incorporated by reference in the current
and final rule. This reevaluation will
involve a complicated set of legal,
regulatory, and technical information
that will need to be carefully
considered.
a. Summary of Major Comments
Regarding the Decision To Retain the
Current Beta Particle and Photon
Radioactivity MCL
Of the 70 commenters who responded
to the April 21, 2000 NODA,
approximately 14 commented on the
MCL for beta particle and photon
radioactivity. The commenters
represented Federal agencies, State
governments, local governments, water
utilities, water associations, nuclear
institute representatives and public
interest groups. Seven commenters
support EPA's proposal to retain the
current MCL and several of these
commenters agreed that it was
appropriate to review the standard
under the six year review process 9. The
commenters that supported EPA's
proposal to maintain this MCL felt there
was no appreciable occurrence of man-
made beta emitters in drinking water, so
it was not a pressing public health
concern to revise the MCL. Several of
these commenters also felt it was
appropriate to delay action on lead-210
until more occurrence information
becomes available.
Three of the 14 commenters objected
to EPA's proposal to retain the current
standard and to defer re-evaluation to
the statutorily required six year process.
These commenters felt that the Agency
should propose to update the models
used as the basis for the MCL on a
shorter time-frame than the six year
review process. The commenters felt
that deferring the reevaluation of beta/
photons to the six year review process
would increase and perpetuate the
uncertainty involved with standards
which are used in waste management
and cleanup decisions. One commenter
pointed out that most DOE sites with
the current MCL and the methodology incorporated
by reference in the current rule.
n Six Year Review Process—Under the Safe
Drinking Water Act (SDWA), the U.S. :
Environmental Protection Agency (EPA) must
periodically review.existing National Primary
Drinking Water Regulations (NPDWRs) and, if
appropriate, revise them. This requirement is
contained in section 1412(b)(9) of SDWA, as
amended in 1996, which reads, "The Administrator
shall, not less often than every 6 years, review and
revise, as appropriate, each national primary
drinking water regulation promulgated under this
title. Any revision of a national primary drinking
water regulation shall bo promulgated in
accordance with this section, except that each
revision shall maintain, or provide for greater,
protection of the health of persons/'
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Federal Register/Vol. 65, No. 236/Thursday, December 7, 2000/Rules and Regulations 76717
radiological contamination are moving
towards the final Record of Decision
(ROD) stage (as required as part of site
clean-up under the Superfund Program).
The commenter felt that delaying the re-
evaluation of this MCL until the next six
year review process (2002—2008) would
occur after most RQDs were already in
place and it would be too late to
incorporate a new-MCL into the RODs,
The commenter further stated that some
ROD commitments will be using clean
up standards based on the 1976 values
and if the standards are eventually
relaxed, the committed RODs (which
were based on the 1976 values) will be
extremely expensive and may not be
justifiable. EPA agrees that review of the
MCL for beta particle and photon
radioactivity is a priority and, as
previously discussed in this section, the
Agency intends to review this standard
within the general time frame
established for the U.S. Department of
Energy's (DOE) submission of the
licensing application for the Yucca
Mountain site.
4. Retaining the Current Gross Alpha
Particle Activity MCL
In 1991, EPA proposed excluding
radium-226 from adjusted gross alpha
particle activity, which is currently
defined as the gross alpha particle
activity result minus the contributions
from uranium and radon (in practice, it
is not necessary to exclude radon, since
it volatilizes before analysis). The 1991
proposal to increase the combined
radium-226/-228 MCL from 5 pCi/L
combined to 20 pCi/L each made the
adjusted gross alpha definition
necessary, since the radium-226 MCL
exceeded the adjusted gross alpha
particle activity MCL. Besides
addressing this inconsistency, at the
time EPA believed that the unit risk
from radium-226 was small enough that
the change in the definition of adjusted
gross alpha particle activity would not
result in a significant change in health
protectiveness. As discussed in the
NODA, the 1991 risk analysis was based
on the EPA RADRISK model, which is
now outdated.
The most current risk analyses are
based on FGR—13, discussed previously
in today's preamble and in detail in the
NODA and its Technical Support
Document. These new radionuclide
cancer risk coefficients greatly improved
health effects analyses indicate that the
unit risk from radium-226 is too
significant to exclude radium-226 from
adjusted gross alpha particle activity
without an appreciable loss in health
protectiveness. For this reason, today's
rule does not change the definition of
adjusted gross alpha from the current
rule.
Also, as discussed in the NODA,
further occurrence data will be collected
for polonium-210 and radium-224
(discussed in more detail next) and,
based on findings, EPA may propose in
the future to address these and/or other
contaminants that contribute to gross
alpha particle activity through changes
to the definition of adjusted gross alpha
particle activity. Regardless of the
findings concerning polonium-210 and
radium-224 occurrence, the gross alpha
particle activity standard will be
reviewed under the required six year
regulatory review process.
a. Summary of Major Comments
Regarding the Decision to Retain the
Current Definition of the (Adjusted)
Gross Alpha Particle Activity MCL
Of the 70 commenters -who responded
to the April 21, 2000 NODA,
approximately 23 commented on issues
regarding the gross alpha particle
activity MCL and/or whether or not to
regulate polonium-210 and/or radium-
224 separately. The summary of the
comments regarding radium-224 is
discussed further in the next section.
The commenters represented State
governments, local governments, water
associations, water utilities, associations
of elected officials and public interest
groups. Of these 23 commenters, 14
stated that EPA should not regulate
polonium-210 and/or radium-224
separately. Some commenters felt either
the occurrence of these radionuclides is
rare in water supplies or they felt that
not enough occurrence data was
available to warrant separate limits. EPA
agrees that occurrence information
should be collected before proposing
separate standards. Commenters felt that
occurrence information should, be
gathered under an unregulated
contaminant monitoring mechanism,
which EPA is doing in.the case of
polonium-210. Only one commenter
supported an immediate separate
standard for polonium-210 and quick
gross alpha particle activity analysis to
ensure that radium-224 was included in
gross alpha particle activity
measurement. EPA points out that a
proposal would be necessary for such
actions and that a proposal would
require adequate occurrence
information. Of those commenters who
commented on retaining the current
definition of the gross alpha particle
activity MCL, including radium-226,
most supported retaining the standard
as is. However, three commenters stated
that radium-226 should not be included
in the gross alpha particle activity MCL,
since it is already regulated in the
combined radium-226/-228 standard.
EPA points out that the contribution
from radium-226 to the over-all risk
from gross alpha particle activity is
significant and that removing it would
reduce the health protectiveness of the
gross alpha particle activity standard.
Also, two commenters felt that gross
alpha particle activity should only be
used as a screening tool (versus a
standard) since the commonly occurring
alpha emitting radionuclides are already
covered under other standards. EPA
points out polonium-210 is not
regulated under any other standard at
this time. The gross alpha particle
activity standard will be reviewed under
six year review and these and other
considerations will be taken into
account.
5. Further Study of Radium-224
As discussed in section I.C., recent
studies show that there is a positive
correlation between radium-228 and
radium-224 (correlation coefficient of
0.82, approximately 1:1). This
correlation means that in most
situations in which a system has high
radium-224 levels, it will also have high
radium-228 levels and, with a less
degree of certainty, high radium-226
levels. More details on this relationship,
including the summary statistics, can be
found in the NODA and its Technical
Support Document (USEPA 2000e and
2000h). The expected result of these
correlations is that high radium-224
levels will be mitigated by enforcement
of the combined radium-226/-228 MCL,
keeping in mind that treatment for
radium does not differentiate between
the different isotopes. Since radium-228
is estimated to be eight times more
radiotoxic than radium-224, it appears
that radium-224 may not be a pressing
public health concern compared to the
co-occurring regulated contaminant
radium-228. The Agency plans to collect
'additional national occurrence
information for radium-224, which may
involve coordination with the USGS,
and will evaluate whether future
regulatory action or guidance is
necessary. Radium-224 occurrence data
collection activities are not as high a
priority as addressing other
radionuclide commitments such as the
review of the beta particle and photon
radioactivity MCL.
For several reasons, a change in the
gross alpha particle activity holding
time has been determined to be an
inappropriate regulatory solution. First,
the uncertainty in the national
occurrence data does not allow EPA to
determine the number of systems out of
compliance with the gross alpha particle
activity standard due to radium-224 if a
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76718 Federal Register/Vol. 65, No. 236/Thursday, December 7, 2000/Rules and Regulations
48-72 hour holding time is required.
Since this change may result in a
significant number of systems out of
compliance with the current gross alpha
particle activity MCL, EPA would need
to issue a proposed amendment before
making such a change. Such a proposal
would require national level occurrence
data for radium-224 in drinking water.
Since EPA's next course of action is to
collect such data to determine if a
proposal is needed, EPA believes that
this course of action is the appropriate
one.
a. Summary of Major Comments on
Radium-224
(1) The Use of a Short Gross Alpha
Particle Activity Sample Holding Time
to Measure Radium-224: Several
commenters stated that the use of a
short gross alpha sample holding time to
* measure radium-224 would raise
technical difficulties and would be
costly. Several commenters stated that
there was not enough information to
warrant a change to the gross alpha
holding time or to regulate radium-224
separately. EPA agrees with this
comment and, as stated in the Notice of
Data Availability (NODA; USEPA
2000e), will not change the gross alpha
holding time or regulate radium-224
separately in today's final rule. Some
commenters stated that it would not be
appropriate to change the holding time
or to issue a separate standard in the
final rule without a proposal. This is in
agreement with what the Agency stated
in the NODA.
(2) The Need to Regulate Radium-224:
One commenter suggested that the
radium-224 cancer mortality risk
coefficient from Federal Guidance
Report-13 (FGR-13) warranted a health
concern and warranted regulating
radium-224. While EPA agrees that
radium-224 is a health concern, the
radium-224 cancer mortality unit risk is
eight times less than the radium-228
cancer mortality unit risk. In other
words, it would take 40 pCi/L of
radium-224 to present an equal cancer
mortality risk as 5 pCi/L of radium-228.
Since the correlation between radium-
224 and radium-228 is approximately
one-to-one (1:1) in the areas known to
be of concern, one would typically
expect to find 5 pCi/L of radium-224
associated with 5 pCi/L of radium-228.
Since radium-226 and radium-228 also
significantly co-occur, EPA believes that
in most situations in which radium-224
occurs it would be present at levels
lower than 5 pCi/L for systems in
compliance with the combined radium-
2267-228 standard. Table 1-3 shows the
predicted increase in risk for water
systems in areas in which radium-224 is
known to co-occur with radium-228,
assuming a 1:1 correlation. This table
shows that the presence of radium-224
increases the over-all combined radium
risk by 5%-13%, depending on the
relative contributions of radium-226 to
radium-228 to the MCL of 5 pCi/L. EPA
believes that this situation indicates that
radium-224 may be of concern in some
areas, but also believes that collecting
data to determine if radium-224 is of
national concern is the appropriate next
step for determining if radium-224
should be regulated separately.
TABLE 1-3—TYPICAL INCREASE IN COMBINED RADIUM RISK DUE TO PRESENCE OF RA-224 FOR WATER SYSTEMS WITH
COMBINED RA-226/-228 LEVELS OF 5 PCi/L, ASSUMING A 1:1 CORRELATION OF RA-224 AND. RA-228
Ra-226 (pCi/L)
4
3
0
Ra-228 (pCi/L)
0
1
2
3
4
5
Ra-224 (pCi/L)
0
1
2
3
4
5
Percent increase in risk due to
presence of Ra-224
0%
5%
8%
10%
12%
13%
6. Entry Point Monitoring and the
Standardized Monitoring Framework
The changes to the existing
distribution system-hased monitoring
scheme proposed in 1991 are
promulgated in today's final rule. New
monitoring must be performed at entry
points to the distribution system, which
is meant to ensure that all customers are
protected by the radionuclides
NPDWRs. The 1976 monitoring scheme
ensured that "average customers" were
protected, but did not ensure that all
customers were served by water at or
below the MCL for the various
radionuclides.
While EPA is finalizing a change to
the point of compliance from a
representative distribution system
sampling point to all points of entry to
the distribution system, EPA realizes
that unless data grandfathering is
allowed, many systems will have to re-
establish monitoring baselines that have
been established for many years. The
"monitoring baseline" refers to the
average contaminant level analytical
result that is used for determining the
future monitoring frequency. For this
reason, EPA is allowing primacy entities
(States, Tribes, and other) the option of
developing data grandfathering plans
that are suited to their individual
situations (e.g., occurrence patterns,
water system configurations, and other
factors) as a part of then- primacy
packages. This situation will allow
primacy entities flexibility to
grandfather historical data for
determining future monitoring
frequencies, while allowing EPA
oversight of the process to ensure that
the goal of having each entry point in
compliance with the MCLs is met. Since
future monitoring will be conducted at
each entry point, this approach will
ensure that compliance is achieved at
every entry point.
The new requirements for uranium
and radium-228 will mean that initial
monitoring baselines for determining
future monitoring frequencies will need
to be established. Only community
water systems that have gross alpha
particle activity screening levels greater
that 15 pCi/L will be required to
monitor for uranium. Thus, many
systems will be able to use historical
gross alpha data to determine future
monitoring frequency under the
uranium standard. And, since the
current monitoring requirements for
gross alpha particle activity already
require systems with gross alpha
particle activity levels greater than 15
pCi/L to quantify uranium levels (to
subtract out the uranium contribution to
the gross alpha particle activity), EPA
expects that many of these water
systems will also be able to grandfather
historical uranium data. Given this
situation, EPA does not expect uranium
monitoring requirements to be overly
burdensome to community water
systems or drinking water programs.
Community water systems, without
historical radium-228 data (expected to
be those with gross alpha particle
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Federal Register/Vol. 65, No. 236/Thursday, December 7, 2000/Rules and Regulations 76719
activity levels less than 5 pCi/L and
radium-226 levels less than 3 pCi/L)
will need to establish an initial
monitoring baseline to determine future
monitoring frequency. Four consecutive
quarterly samples will be required to
establish this baseline. However, States
and Tribes may waive the last two
quarterly samples and determine the
initial monitoring baseline on the first
two samples if the results for the first
two samples are below the detection
limit (1 pCi/L), which would be
considered a non-detect and would be
reported as "zero" (this discussion
assumes that radium-226 levels are also
non-detects and are reported as zero).
Systems with non-detects for radium-
228 and radium-226 would have to
monitor once every nine years after the
initial monitoring period. Other
monitoring requirements are discussed
in section I.J.
7. Separate Monitoring for Radium-228
and Change to Systems Required To
Monitor for Beta Particle and Photon
Radioactivity
Separate monitoring for radium-228,
proposed in 1991, is promulgated in
today's rule. The need for separate
monitoring of radium-228 is supported
by the occurrence studies supporting
the 1991 proposal and new occurrence
studies (USEPA 2000e and i), which
indicate that the 1976 radium-228
screens are not robust. Since the unit
risks for radium-228 are higher than for
radium-226 (described in the NODA and
its Technical Support Document,
USEPA 2000e and h), EPA believes that
separate monitoring for radium-228, as
proposed in 1991, is essential to
enforcing the combined radium-226/-
228 standard.
In addition, today's rule eliminates
the previous requirement that all surface
water systems serving more than
100,000 persons must monitor for beta
particles and photon radioactivity. Beta
particle and photon radioactivity
monitoring will be performed only by
community water systems designated by
the State as "vulnerable" or
"contaminated". In 1976, the Agency
was concerned about nuclear fallout
contaminating surface water sources.
The Agency anticipated that large
surface water systems [i.e. systems
serving greater than 100,000 persons)
would be vulnerable to becoming
contaminated by nuclear testing
activities. Therefore, the radionuclides
regulation required all surface water
systems serving more than 100,000
persons and any other systems
determined by the State to be vulnerable
to monitor for beta and photon emitters.
Since that time above-ground testing
of nuclear •weapons has been banned,
and sources of man-made radiation are
not expected, thus, large surface water
systems are not automatically
vulnerable to beta and photon emitters.
As a result, the Agency has reevaluated
the 1975 approach, and in today's rule,
as proposed in 1991, is removing the
requirement for all large surface water
systems to monitor for beta and photon
emitters, unless they have been
designated as vulnerable by the State.
The Agency believes that States are in
the best position to determine which
systems are vulnerable to beta and
photon emitters. The EPA is also
encouraging States to reevaluate a
system's vulnerability to beta photon
emitters when conducting source water
assessments and provide immediate
notification to those systems that have
been deemed vulnerable.
8. Future Actions Regarding the
Regulation of Radionuclides at Non-
Transient Non-Community Water
Systems
EPA will not regulate NTNC water
systems with today's rule, but may
propose to do so in the future. As
described in the NODA (USEPA 2000e),
EPA considered regulating non-transient
non-community (NTNC) water systems
for today's final rule, as proposed in
1991. The NODA also described EPA's
analysis of the risks faced by customers
of NTNC water systems, potential risk
reductions, and compliance costs. EPA
stated that several options were being
considered for finalization: (1) Not
regulating NTNC water systems; (2)
regulating all NTNC water systems
under the same requirements faced by
CWSs; (3) regulating targeted NTNC
water systems, based on occurrence
potential, typical lengths of exposure,
the age distribution of typical
customers, and other factors; (4) issuing
guidance recommending that States
require that targeted NTNC systems
monitor, and in some cases, mitigate to
acceptable levels.
EPA's rationale for not regulating
NTNC water systems at this tune is
based upon consideration of several
factors. EPA summarized the results of
a conservative Monte Carlo analysis of
risks at NTNC water systems in the
NODA and discussed the analysis in
more detail in its Technical Support
Document (USEPA 2000h). After
evaluating the available information and
the various comments on the NODA,
EPA does not believe that exposure to
radionuclides by consumers of water
from NTNC systems poses an
unacceptable health risk. This
conclusion is based on consideration of
the total pattern of exposure of
individuals, considering their
consumption of both NTNC water and
water from other types of water systems.
However, EPA's information for these
radionuclides is limited and will be the
subject of additional future analyses and
reevaluation, together with any new
data that can be obtained.
In the immediate future and in
consultation with the National Drinking
Water Advisory Committee (NDWAC),
EPA will further evaluate various
approaches to regulating NTNCs
generally (including radionuclides).
This further analysis will involve
examination of additional data and
information and will include further
analysis of a full range of possible
options. In this evaluation, EPA will
consider risk analyses for adults and
children, occurrence patterns, the
national distribution of NTNC water
systems, and other factors. In
determining the appropriate action, EPA
will 'consider the issue of consistency
between the various regulations for
chronic contaminants applicable to
NTNC water systems, including future
rules.
a. Summary of Major Comments on
NTNCWSs and EPA Responses
Of the 70 commenters who responded
to the April 21, 2000 NODA,
approximately 31 commented on the
issue of NTNC water systems and the
options presented in the NODA. About
75 percent of these 31 commenters
oppose regulation of NTNC water
systems. While several of the
commenters felt that EPA should only
require targeted monitoring, many
commenters felt that monitoring of
NTNC water systems should be left to
the discretion of the States. A few
commenters felt that EPA should treat
NTNC water systems like CWSs and
require regulation and some
commenters felt partial coverage of
targeted NTNC water systems would be
appropriate.
Those opposed to the regulation of
NTNC water systems felt the cost/
benefit and risk analyses presented in
the NODA did not support a
requirement to regulate. Some of those
opposed to regulating NTNC water
systems believe EPA needs to gather
more information about the occurrence
of radionuclides, the amount and
percentage of water consumed, and the
duration of exposure at NTNC water
systems. Many commenters felt that
EPA should allow States the flexibility
or discretion to determine whether or
not to regulate NTNC water systems and
leave it to the States to target specific
NTNC water systems. Some commenters
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76720 Federal Register/Vol. 65, No. 236/Thursday, December 7, 2000 /Rules and Regulations
suggested that EPA issue guidance that
recommends targeted NTNC water
systems monitor and meet the CWS
MCLs. In addition, some commenters
stated that EPA should be consistent in
all their rules when considering
whether or not to regulate NTNC water
systems. EPA believes that all of these
comments have merit and that the
regulation of radionuclides at NTNC
water systems deserves further
evaluation along with an analysis of
additional data and information. If EPA
proposes to regulate NTNC water
systems in the future, stakeholders will
have future opportunity to comment.
Regarding State discretion, States may at
any time choose to regulate NTNC water
systems, either under a targeted rule or
otherwise.
E. What Are the Health Effects That May
Result From Exposure to Radionuclides
in Drinking Water?
Radioactive drinking water
contaminants differ from one another in
•ways that determine their harmfulness.
Each radionuclide has a particular half-
life and emits characteristic forms of
radiation (alpha particles, beta particles,
and/or photons). A radionuclide's half-
life and concentration determine its
radioactivity, i.e., the number of
radioactive "decay events" that occur in
a particular unit of time. These factors,
concentration, half-life, form of
radioactive decay, and radiation energy,
all determine a particular radionuclide's
potential for impacting human health. .
For a discussion of half-life and the
different forms of radioactive decay, see
Appendix I ("Fundamentals of
Radioactivity in Drinking Water") to the
Radionuclides NODA's Technical
Support Document (USEPA 2000h).
The potential for harmful health
effects from exposure to radioactive
compounds results from the ability of
ionizing radiation to chemically change
the molecules that make-up biological
tissues (e.g., stomach, liver, lung)
through a process called "ionization."
The radiation (alpha and beta particles
and photons) emitted by radionuclides
is called "ionizing radiation" because
the radiation has sufficient energy to
strip electrons from nearby atoms as
they travel through a cell or other
material. Ionization may result in
significant chemical changes to
biologically important molecules. For
example, ionizing radiation can damage
important molecules like DNA. DNA is
the elementary building block for genes
and the diemical that carries genetic
information involved in many
fundamental biological processes.
Damage to the DNA of an individual
gene may cause the gene to mutate,
changing a cell's genetic code. Such
mutation can lead to cancer. Since
ionizing radiation may damage genes, it
can adversely affect individuals directly
exposed as well as their descendants.
While much of this cellular damage is
repaired by the body, restoring proper
biological functions, the net result of an
increase in exposure to ionizing
radiation is an increase in the risk of
cancer or harmful genetic mutations that
may be passed on to future generations.
(See, EPA's fact sheets on ionizing
radiation and associated health effects at
http://wwwr.epa.gov/radiation/
ionize.htm and in the record of this final
rulemaking; (USEPA 1998a andl998c)).
Alpha emitters and beta/photon
emitters differ in the magnitude of their
biological effects. Alpha particles
interact very strongly with matter (e.g.,
human tissues), transferring their energy
through these interactions. Beta
particles interact less strongly, which
allows them to travel further through
tissue before being absorbed. The
difference of interest is in the
concentration of tissue damage. Alpha
particles may damage many molecules
over a short distance, while beta
particles may damage molecules spread
out over a greater distance. The actual
number of potentially damaged
molecules depends upon the energy of
the alpha particle or beta particle
(which differs between individual alpha
emitters and beta emitters). Photon
emissions may also interact with
tissues, but they interact over much
longer distances (they can pass through
the body entirely). Exposure to any of
these forms of radiation increases the
risk of cancer.
All people are chronically exposed to
background levels of radiation present
in the environment. Many people also
receive additional chronic exposures,
including exposure to radionuclides in
drinking water, and/or relatively small
acute exposures, for example from
medical X-rays. For populations
receiving such exposures, the primary
concern, is that radiation could increase
the risk of cancers or harmful genetic
effects.
The likelihood of developing cancer
or genetic mutations from short-term
exposure to the concentrations of
radionuclides found in drinking water
supplies is negligible. However, long-
term exposures may result in increased
risks of genetic effects and other effects
such as cancer, precancerous lesions,
benign tumors, and congenital defects.
For example, an individual that is
exposed to relatively high levels of
radium-228 (e.g., 20 pCi/L) in drinking
water over the course of a lifetime is
projected to have a significantly
increased chance of developing fatal
cancer (roughly a one in one thousand
increased risk if exposed to radium-228
at 20 pCi/L over a lifetime of 70 years).
The probability of a radiation-caused
cancer or genetic effect is related to the
total amount of radiation accumulated
by an individual. Based on current
scientific models, it is assumed that any
exposure to radiation may be harmful
(or may increase the risk of cancer);
however, at very low exposures (e.g.,
drinking water exposures below the
MCL), the estimated increases in risk are
very small and uncertain. For this
reason, cancer rates in populations
receiving very low doses of radiation
may not show increases over the rates
for unexposed populations.
For information on effects at high
levels of exposure, scientists largely
depend on epidemiological data on
survivors of the Japanese atomic bomb
explosions and on people receiving
large doses of radiation for medical
purposes. These data demonstrate a
higher incidence of cancer among
exposed individuals and a greater
probability of cancer as the exposure
increases. In the absence of more direct
information, that data is also used to
estimate what the effects could be at
lower exposures. Where questions arise,
scientists extrapolate from information
. obtained from cellular and molecular
studies, but these extrapolations are
acknowledged to be only estimates.
Professionals in the radiation protection
field prudently assume that the chance
of a fatal cancer from radiation exposure
increases in proportion to the
magnitude of the exposure.
In the case of uranium in drinking
water, we must consider not only
carcinogenic health effects but also ..
damage to the kidneys that may result
from ingestion. When uranium
radioactively decays in the body, it
results in increased cancer risks.
However, natural uranium isotopes have
long half-lives, which means that
uranium tends to persist in the body
until it is excreted or stored in tissue. As
discussed in detail in the Notice of Data
Availability (USEPA 2000e), its
Technical Support Document (USEPA
2000h), and the Toxicological Review of
Uranium (USEPA 2000b) this persistent
uranium may result in kidney toxicity.
See section I.D.2 for a brief summary of
kidney (renal) function and uranium
toxicity.
1. Major Comments
Most comments on Health Effects
related to three areas of risk estimation:
(1) The use of a linear, non-threshold
model, (2) not finding a threshold for
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Federal Register/Vol. 65, No. 236/Thursday, December 7, 2000/Rules and Regulations 76721
radium, and [3) not promoting claimed
beneficial effects of ionizing radiation.
a. Linear Non-threshold Model: Some
commenters suggested that the Agency
abandon the linear nonthreshold (LNT)
model it employs to estimate radiation
induced carcinogenesis. They suggest a
new paradigm should be used.
The Agency disagrees and believes its
position is based on weight of evidence
and support from national and
international groups of experts
interested in radiation protection. EPA
classifies all radionuclides as Group A
(known human) carcinogens. This
classification is based on the
considerable weight of epidemiological
evidence that exposure to high doses of
ionizing radiation causes cancer in
humans and on the fact that all
radionuclides emit ionizing radiation.
Radiation has been shown to induce
unique DNA damage, mutations, and
transformation of cells in culture. The
monoclonal nature of cancers is
evidence that a single "wild" cell can
give rise to a cancer. For alpha particles,
it has been shown experimentally that a
single alpha passing through a cell is
sufficient to induce a mutational event;
there are strong theoretical reasons to
expect that the same is true for low
energy transfer (LET) radiation such as
gamma rays. Since a single particle
traversal of a cell is the minimum event
for radiation exposure, a prudent
assumption is that there is no threshold
for radiation induced mutations.
To estimate radiogenic cancer risks
and to regulate low-dose radiation
exposures from continuous intakes of
radionuclides in environmental media,
EPA uses a linear, non-threshold (LNT)
dose-response model. The LNT model
permits direct extrapolation of low-dose
cancer risks from high-dose exposures—
allowing for adjustments, as needed, for
differences in radiation quality, dose
rate, and exposed populations,
including such factors as age at
exposure, time since exposure, baseline
cancer rates, and gender and assumes
that there is no threshold for effects; i.e.,
it is assumed that exposure to any
amount of radioactivity has a finite
potential to induce cancers in humans.
As noted above, support for the LNT
model comes in part from the linear
dose-response relationships observed
for most types of cancers in the
intermediate- to high-dose range for
atomic bomb survivors, and from results
of molecular and cellular studies.
Several such studies have shown that a
single radiation track traversing a cell
nucleus can cause unrepaired or
misrepaired DNA lesions and
chromosomal aberrations. Other studies
have shown that DNA lesions and
chromosomal aberrations, can lead to
cancer. From these studies, it is
assumed that the probability of DNA
damage and carcinogenesis is linearly
proportional to the dose.
EPA's application of the LNT model
to estimate and regulate cancer risks
from environmental exposures to
radionuclides is entirely consistent with
all past and current observations and
recommendations of the International
Commission on Radiological Protection
(ICRP), the National Council on
Radiation Protection and Measurements
(NCRP), the National Academy of
Sciences Committee on the Biological
Effects of Ionizing Radiation (BEIR), and
the United Nations Scientific Committee
on the Effect of Atomic Radiation
(UNSCEAR), and the National Radiation
Protection Board (NRBP). Citing the
recommendations of these national and
international advisory bodies, the U.S.
Department of Energy, the U.S. Nuclear
Regulatory Commission, and other
Federal and State agencies with
regulatory authority over radioactive
materials also apply the LNT model as
the basis for setting regulations and
guidelines for radiation protection.
However, to address these limitations
and the uncertainties associated with
this model and improve its radiation
risk assessments, EPA is actively
supporting national and international
studies of radiation dosimetry and dose
reconstruction, radionuclide
biokinetics, quantitative techniques for
uncertainty analyses, and long-term
follow-up epidemiological studies of
populations exposed chronically to low-
dose radiation. The Agency also
continues to review its policies and
positions as new reports and data are
published so that the best science is
applied.
b. Radium Carcinogenicity Threshold:
Some commenters have suggested that
there is a threshold for radium
Carcinogenicity. They generally base
this conclusion on the "Radium Dial
Painter" studies.
The Agency disagrees. While the
"Radium Dial Painter" studies are
interesting, they are of limited value for.
the estimation of risk. First, no one
knows the quantity of radium ingested
in those studies, so dose estimates are
speculative. The intake estimates are
based on the body burden the first time
the subjects were measured and back-
calculated with biokinetics modeling.
Moreover, the quantities of radium
ingested by the subjects was great
enough to cause extensive skeletal
pathology and interfere with normal
bone metabolism. In addition to
problems of radium dosimetry, the high
mortality in some groups, and the small
numbers of subjects in all exposure
groups, would impair use of the data to
develop dose response relationships.
Only a small fraction of persons
known to have been exposed to radium
have been located and their radium
content at that time measured. Of 6,675
subjects identified above as being in the
data base and as having been exposed to
radium, 2,383 have been measured to
determine their radium-226 burden. (21
of the 85 osteosarcomas occurred in
subjects who had never been measured
for radium burden.) Since the radium
intake in dial painters is unknown, body
burden is known only from the date of
first radioassay (usually many years
after the radium intake), and
metabolism is estimated from other
sources, estimates of the radiation dose
must be based on a series of poorly
verified assumptions. In spite of these
inherent problems in the data set, efforts
have been made to use the radium dial
workers, or some subset of them, to
establish a "practical threshold" for
radium or other internal emitter
exposure.
The "practical threshold" concept is
derived from studies of chemical
carcinogenesis which include dose
levels causing extensive life shortening.
Plots of the mean age at tumor onset vs
dose indicates an increase in tumor
latency with decreasing dose.
Extrapolation of these curves to
environmental dose levels has led some
investigators to conclude at these dose
levels tumor latency would exceed the
human life span. This "practical
threshold" is as an argument for a
threshold and against LNT models. The
"practical threshold" model has been
examined and rejected by experts at the
International Agency for Research on
Cancer (IARC). The IARC warned in
their discussion regarding mean tumor
latency or mean age at tumor onset that
"care must be taken not to extrapolate
the observed tendency for the mean age
at onset to increase with decreasing
dose below the dose range in which
most animals get cancer. Failure to
observe this restriction has led to the
unjustified speculation that
progressively lower and lower human
doses of environmental contaminants
will produce cancers only at age 200 or
300 years; for refutation, see Peto
(1978)."
Even if there were no problems with
intake, dose, metabolism, extensive
pathology, etc., as mentioned above, the
radium dial studies would be
uninformative on the subject of the dose
response relationship at environmental
exposure levels. The number of subjects
and their distribution in dose categories
is too small. The number of subjects
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76722 Federal Register/Vol. 65, No. 236/Thuisday, December 7, 2000/Rules and Regulations
needed to show a given risk increases as
the square of the decrease in dose. For
example, if 10 subjects are required to
show an radiogenic risk at dose level x,
250 would be needed to show the same
risk at dose level x/5, and 1000 at dose
level x/10. There just are not enough
subjects at lower dose levels to show the
risk, giving the illusion of a threshold.
The claims regarding a possible
"practical threshold" addressed above
are based solely on the bone cancer
data. However, bone cancer constitutes
only a fraction of the estimated risk
from ingested radium. Radium-226 has
also been found to induce epithelial
cancers in sinuses in the head [due to
radon-222 released into the sinus air
spaces from the decay of radium-226 in
bone). The data in the dial painter study
is inadequate to develop a dose
response relationship for sinus cancers,
however the number of epithelial
cancers expected in the dial painters is
about the same as the number of bone
cancers. The number of bone cancers in
the Agency's radium-226 risk model is
doubled to get an estimate of combined
bone and sinus cancers. In addition to
bone cancer, patients treated with
radium-224 were found to have
significant increases in breast cancer,
soft tissue sarcomas, liver cancer,
thyroid cancer, cancers of urinary
organs, and leukemia. Given our
understanding of radium metabolism
and the effects of alpha irradiation, it is
expected that ingestion of any of the
radium isotopes will increase the risks
for various types of cancer other than
bone. EPA's risk estimates include all
these potential sites.
c. "Beneficial Effects" of Radiation:
One commenter suggests there are
beneficial effects of radiation,
"Hormesis" (small doses of radiation are
good for you) and "Adaptive Response"
(relatively small doses of radiation
protect against large doses of radiation).
The Agency finds that, based on
available scientific evidence, these
phenomena are not relevant to
environmental radiation protection.
Neither has been shown to occur at
environmental dose levels. Neither has
been shown to influence the dose
response for induction of radiation
induced cancer. Hormesis has not been
demonstrated in normal healthy active
populations of mammals, much less in
humans. Adaptive response may have
some application in radiotherapy (very
high radiation doses), but it is not
relevant to environmental exposure
levels.
Hormesis is a non-specific
phenomenon. Biological, chemical, or
physical agents may stimulate hormesis;
thus, cold, physical stress, toxic
chemicals, antibiotics, as well as
ionizing radiation, can be hormetins.
Hormesis originally was used to
describe a stimulatory effect, which was
not inherently good or bad. Recent
usage of the term "Radiation Hormesis"
implies the discussion relates to
beneficial effects. It should not,
however, imply absence of radiation
carcinogenesis.
The "adaptive response" is also a
nonspecific response to stress, which
has been observed at the cellular level.
An "adaptive response" is observed
experimentally when a "conditioning"
exposure is given, followed at some
later time by a "challenge" exposure,
and the response in the "conditioned"
organism or cell culture is less than in
controls; that is, the conditioning
exposure was "protective" against the
challenge. In typical studies where cells
in culture are given a conditioning dose
of radiation in the range of 0.2 to 20 rad
(2 to 200 milliGray or mGy), a dose of
100 to 200 rad (1000 to 2000 mGy) given
later causes only about 50% as great an
effect as that observed in controls with
no conditioning exposure. However
several points are noteworthy: not all
cells respond, effects may be different
for cells at different stages in the cell
cycle, not all conditioning doses give
the same response (sometimes instead of
protection there is synergism between
doses), the "adaptive" effects are
transient, and the timing of the
challenge dose may be critical to
response. Given these limitations, EPA
does not believe it is appropriate at this
time to consider such an adaptive
response in its assessment of the risks
from environmental levels of radiation.
F. Does This Regulation Apply to My
Water System?
The NPDWRs for combined radium-
226 arid radium-228, gross alpha
particle radioactivity, beta particle and
photon radioactivity, and uranium
apply to all community •water systems.
G. What Are the Final Drinking Water
Regulatory Standards for Radionuclides
(Maximum Contaminant Level Goals
and Maximum Contaminant Levels)?
The maximum contaminant level
goals (non-enforceable health-based
target, MCLGs) and maximum
contaminant levels (enforceable
regulatory limits, MCLs) are listed in
table 1-4. For the reasons already
described, EPA is retaining the existing
MCLs for combined radium-226 and
radium-228, gross alpha, and beta
particle and photon radioactivity. EPA
is finalizing an MCL of 30 ng/L for
uranium, based on kidney toxicity and
cancer risk endpoints. The final MCLGs
are zero for all radionuclides, based on
the no-threshold cancer risk model for •
ionizing radiation.
TABLE 1-4.—MCLGs AND MCLs FOR RADIONUCLIDES IN DRINKING WATER (OTHER THAN RADON)
Contaminant
Beta Particle and Photon Radioactivity
Uranium
MCLG (pCi/L)
Zero
Zero
Zero
Zero
MCL
5 pCi/L.
15 pCi/L.
4 mrem/year.
30 ng/L.
H. What Are the Best Available
Technologies (BATs) for Removing
Radionuclides From Drinking Water?
Under the SDWA, EPA must specify
the best available technology (BAT) for
each MCL that is set. PWSs that are
unable to achieve an MCL may be
granted a variance if they use the BAT
and meet other requirements (see
section I.M for a discussion of variances
and exemptions). Table 1-5 lists the best
available technologies (BATs) for
complying with the radionuclides
MCLs. '
TABLE 1-5.—BEST AVAILABLE TECHNOLOGIES (BATs) FOR RADIONUCLIDES IN DRINKING WATER
Contaminant
BAT
Combined radium-226 and radium-228 I Ion Exchange, Lime Softening, Reverse Osmosis.
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Federal Register/Vol. 65, No. 236/Thursday, December 7, 2000/Rules and Regulations "76723
TABLE 1-5.—BEST AVAILABLE TECHNOLOGIES (BATs) FOR RADIONUCUDES IN DRINKING WATER—Continued
Contaminant
Gross alpha (excluding radon and uranium)
Beta particle and photon radioactivity
Uranium
BAT
Reverse Osmosis
Bon/Filtration.
In addition to BATs, the SOW A, as
amended in 1996, requires EPA to list
small system compliance technologies
(the requirements are described in
section LMJ..EPA published a list of
small systems compliance technologies
for the existing radionuclide MCLs in
1998 (63 FR 42032) and issued a
guidance document on their use
(USEPA 1998f). EPA took comment on
small system compliance technologies
for uranium in the NODA (USEPA
2000e; 65 FR 21576). Table 1-6 is a
compilation of all of the small systems
compliance technologies for
radionuclides, including limitations,
required operator skill, raw water
quality ranges, and other considerations.
Table 1—7 shows the small systems
compliance technologies listed for:
combined radium-226 and radium-228,
gross alpha particle radioactivity, beta
particle and photon radioactivity, and
uranium.
TABLE 1-6.—LIST OF SMALL SYSTEMS COMPLIANCE TECHNOLOGIES FOR RADIONUCLIDES AND LIMITATIONS TO USE
Unit technologies
Limitations
(see footnotes)
Operator skill level required 1
Raw water quality range &
considerations1
1. Ion Exchange (IE)
2. Point of Use (POU2) IE
3. Reverse Osmosis (RO) .
4. POU2 RO
5. Lime Softening .
6. Green Sand Filtration
7. Co-precipitation with Barium Sulfate
8. Electrodialysis/Electrodialysis Rever-
sal.
9. Pre-formed Hydrous Manganese
Oxide Filtration.
10. Activated alumina
11. Enhanced coagulation/filtration ........
00
00
00
(0
Intermediate
Basic :
Advanced ....
Basic .
Advanced
Basic .-.
Intermediate to Advanced
Basic to Intermediate
Intermediate
Advanced
(0
Advanced
All ground waters.
All ground waters.
Surface waters usually require pre-fil-
tration.
Surface waters usually require pre-fil-
tration.
All waters.
Ground waters with suitable water
quality.
All ground waters.
•All ground waters.
All ground waters; competing anion
concentrations may affect regenera-
tion frequency.
Can treat a wide range of water quali-
ties.
11 National Research Council (NRC). Safe Water from Every Tap: Improving Water Service to Small Communities. National Academy Press.
2 AT "
t l Or "P0int-°f-use" technology is a treatment device installed at a single tap used for the purpose of reducing contaminants in drinking
water at that one tap. POU devices are typically installed at the kitchen tap. See the April 21, 2000 NODA for more details.
Limitations Footnotes to Table I-6: Technologies for Radionudides
•The regeneration solution contains high concentrations of the contaminant ions. Disposal options should be carefully considered before
choosing this technology.
bWhen POU devices are used for compliance, programs for long-term operation, maintenance, and monitoring must be provided bv water util-
ity to ensure proper performance. '
o/ Warer di^P°sal oP«ons should be carefully considered before choosing this technology. See other RO limitations described in the
SWTR Compliance Technologies Table.
"The combination of variable source water quality any the complexity of the water chemistry involved may make this technology too complex
for small surface water systems. «
c Removal efficiencies can vary depending on water quality. :
/This technology may be very limited in application to small systems. Since the process requires static mixing, detention basins, and filtration,
it is most applicable to systems with sufficiently high sulfate levels that already have a suitable filtration treatment train in place
nThis technology is most applicable to small systems that already have filtration in place.
h Handling of chemicals required during regeneration and pH adjustment may be too difficult for small systems without an adequately trained
operator. . . '
•Assumes modification to a coagulation/filtration process already in place. ,
TABLE I-7. — COMPLIANCE TECHNOLOGIES BY SYSTEM SIZE CATEGORY FOR RADIONUCLIDE NPDWRs
Contaminant
Compliance technologiesn for system size categories
(population served)
3,300-10,000
25-500
501-3,300
Combined radium-226 and radium-228
Gross alpha particle activity.
Beta particle activity and phton activity .
1,2,3.4,5,6,7,8.9
3. 4
1.2. 3.4, 5.6,7,8.9 | 1, 2. 3.4, 5, 6. 7. 8,9
3,4
3,4
1. 2. 3, 4 ,.-. ! 1. 2. 3, 4
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76724 Federal Register/Vol. 65, No. 236/Thursday, December 7, 2000/Rules and Regulations
TABLE 1-7.—COMPLIANCE TECHNOLOGIES BY SYSTEM SIZE CATEGORY FOR RADIONUCLIDE NPDWRs—Continued
Contaminant
Uranium
Compliance technologies1 for system size categories
(population served)
25-500
1,2, 4, 10, 11
501-3,300
1,2,3,4,5, 10, 11
3,300-10,000
1,2, 3,4,5, 10, 11
Note: (1) Numbers correspond to those technologies found listed in the table I-6 above.
/. What Analytical Methods Are for
Compliance Monitoring of
Radionuclides?
The approved methods for
compliance monitoring of radionuclides
are listed in § 141.25. These methods are
shown in Table 1-8. A large portion of
the approved methods for radionuclides
were added after the 1991 proposed rule
(56 FR 33050). There, the Agency
proposed to approve fifty-six methods
for the measurement of radionuclides in
drinking water (excluding radon). Fifty-
four of the fifty-six were actually
promulgated in the March 5,1997 final
methods rule (62 FR 10168). In addition
to these fifty-four, EPA also
promulgated 12 radiochemical methods
in the March 5,1997 final methods rule,
which were submitted by commenters
after the 1991 proposed rule.
In the March 5,1997 final methods
rule for radionuclides (62 FR 10168), the
Agency approved several methods for
the analysis of uranium. Specific
analysis for uranium can be performed
by radiochemical methods, alpha
spectrometry, fluorometric (mass), or
laser phosphorimetry (mass) (see Table
1-8). The radio-chemical method
separates and concentrates uranium
from potentially-interfering
radionuclides and non-radioactive
sample constituents. The resulting
concentrate, depending on the method,
can then be counted by gas flow
proportional counting, alpha
scintillation, or alpha spectrometry.
Results from proportional counting or
alpha scintillation counting accurately
determine the alpha emission rate from
total uranium in the sample; however,
the uranium isotope ratio (uranium-234/
uranium-238) cannot be determined and
the uranium mass cannot be estimated
unless an empirical conversion factor is
applied to the measured count rate. The
use of alpha spectrometry allows for the
determination of individual isotopes of
uranium and the accurate calculation of
the mass of uranium-238 present in the
sample. Additionally, the concentration
of uranium-234 can be accurately
measured, if necessary to assess the
radiotoxicity of this isotope.
Both the fluorometric and the laser
phosphorimetry methods measure the
mass of uranium-238 present in the
sample; a conversion factor must be
used to convert the mass measurement
to an approximate radioactivity
concentration in picoCuries. The
computed radioactivity is only
approximate because the ratio of
uranium isotopes must be assumed. The
use of mass-type methods is acceptable
provided a conversion factor of 0.67
pCi/|ig is used to convert the
fluorometric or laser phosphorimetry
uranium-238 mass result from
micrograms to picoCuries. This
conversion factor is conservative and is
based on a 1:1 ratio of uranium-234 to
uranium-238 in uranium-bearing
minerals. The scientific literature
indicates that the activity ratio varies in
ground water from region to region
(typically from 0.67 to 1.5 pCi/ng).
EPA recognizes that the mass
conversion factor is conservative in that
the calculated uranium alpha emission
rate based on the mass measurement
may be biased low (i.e.,
underestimated). The use of this
conversion factor may result in a larger
net gross alpha (gross alpha less the
calculated uranium gross alpha
contribution), •which may require
additional testing to resolve.
Conversely, the calculated mass of
uranium based on gross alpha could be
biased high and result in an
overestimation, which may require
additional testing to resolve. Both
situations are protective in that the bias
requires additional testing to resolve
when the uranium concentration in a
sample is near the proposed MCL
regardless of •which method is used to
measure the uranium.
1. Major Comments
a. Request for ICP-MS Method for
Uranium: In response to the NODA,
several commenters asked EPA to
consider the approval of an Inductively
Coupled Plasma Mass Spectrometry
(ICP-MS) method for uranium analysis
(a mass method). Many commenters
stated that the ICP-MS method (i.e., EPA
200.8 or SM 3125) is more cost-effective,
less labor-intensive and offers greater
sensitivity than some of the currently
approved methods for uranium analysis.
EPA is currently reviewing the ICP-MS
method for uranium and will publish a
proposal and a final in a future
rulemaking.
b. Detection Limit for Uranium: In
1976, the NPDWRs defined the
"detection limit" (DL) as the
"concentration •which can be counted
with a precision of plus or minus 100
percent at the 95 percent confidence
level (1.96 o, where a is the standard
deviation of the net counting rate of the
sample)." The detection limits for gross
alpha, radium-226, radium-228, gross
beta and other radionuclides are listed
at § 141.25 and reproduced in Table I-
9. In the NODA, EPA stated that it
would maintain the use of detection
limits as the required measures of
sensitivity for radiochemical analysis,
instead of using the method detection
limit (MDL), the practical quantitation
level (PQL) and acceptance limits, as
was proposed in 1991. Although no
comments were submitted about EPA's
decision to maintain the use of the
detection limits listed in § 141.25,
several commenters submitted
comments about the appropriate
measure of sensitivity for uranium.
Since uranium was not previously
regulated, no detection limit is listed in
the CFR and none was proposed in
1991. In 1991, the Agency only
proposed a PQL (5 pCi/L) and an
acceptance limit (±30%) for uranium.
Because the NODA was not the
appropriate mechanism to propose a
detection limit for uranium, the Agency
stated that it "may have to adopt the
PQL for uranium until a detection limit
is proposed." Several commenters
disagreed with the use of a PQL and
acceptance limits for uranium. They felt
that EPA should be consistent with
other regulated radionuclides and set a
detection limit for uranium as the
required measure of sensitivity. The
Agency agrees with the commenters and
will propose a detection limit for
uranium in a future rulemaking before
the compliance date of this rule to be
consistent with the sensitivity measures
used for other radionuclides.
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Federal Register/Vol. 65, No. 236/Thursday, December 7, 2000/Rules and Regulations 76725
TABLE 1-8.—ANALYTICAL METHODS APPROVED BY EPA FOR RADIONUCLIDE MONITORING (§141.25)
Contaminant
Naturally occurring:
Gross alpha11 and beta ...
Gross alpha11 ;
Radium 226 .....
Radium 228
Man-made:
Radioactive cesium
Radioactive Strontium 89,
90.
Gamma emitters
Methodology
Evaporation
Radon emanation
Fluorometric
Radiochemical .....
Gamma ray spectrometry
Radiochemical
Gamma ray spectrometry
Gamma ray spectrometry
EPA1
900.0
903.1
903.0
904.0
908.0
908.1
901.C
901.1
902.(
901.1
905.0
906.0
901.1
902.0
901.0
EPA*
p1
pis
p13
p24
P4
P6
p9
p29
p34
EPA3
00-01
00-02
Ra-04
Ra-03
Ra-05
00-07
Sr-4
H-2
EPA"
p1 .
p19
P19
p33
p92 '
P92
p. 65
p. 87
p92
Reference (method. or page number) •
SM5
302,71108
7110 C
7500-Ra C
304, 305, 7500-Ra B
304, 7500-Ra D
7500-U B
7500-U C (17th Ed.)
7500-U C (18th or
19th Ed.)
7500-Cs B
7120
7500-1 B
7500-1 C
7500-1 D
7120 (19th Ed.)
303, 7500-SrB
306.7500-3H B
7120 (19th Ed.)
7500-Cs B
7500-1 B
ASTMS
D 3454-91
D 2460-90
D 2907-91
D 3972-90
D 5174-91
D 2459-72
D 3649-91 .
D 3649-91
O 4785^-88
D 4107-91
D 3649-91
D 4785-88
USGS7
R-1120-76
R-1 141-76
R-1 140-76
R_1 142-76
R-1 180-76
R-1 181-76
R-1182-76
R-1 11 1-76
R-1 11 0-76
R-1171-76
R-1.110-76
DOE8
Ra-05
U-04
U-02
4.5.2.3
4.5.2.3
Sr-01
Sr-02
4.5.2.3
Other
Nff.
N.f.
N.J.1°
vST™^ ' MaUSt 1'980- AVa"able at ""P"*"" of Commerce, National Technical information
2"lnterim Radiochemical Methodology for Drinking Water," EPA 600/4-75-008 (revised). March 1976. Available at NTIS ibid FB3258
,3"Radiochemistry Procedures Manual", EPA 520/5-84-006, December 1987. Available at NTIS, ibid. PB 84-215581
4"Radiochemical Analytical Procedures for Analysis of Environmental Samples." U.S. Department of Energy, March 1979 AvailaataMTIS ibid EMSL LV 053917
=, ,M,ard,M,e"l°ds.forS?-ESmn'JaH?nuf^Vaterand Wastewater. 13th, 17th, 18th, 19th Editions, 1971, 1989, 1992, 1995. AvailaHt American Public Health Association 1015 Fifteenth
?SWff|^^^^^^^
etry is only in the 18th and 19th editions. Method 7120 is only in the 19th edition. Methods 302, 303, 304, 305 and 306 areyjM the 13th edition cu'"on' ana '™u " o «ipna speorom
.. BAnnita Rnntf nf ARTM stanHarrte \/n\ 11 D9 -1QQ4- AmanV^n Cn/>iafi> fnw Tallinn nn«t mt.-. •»»-.!,.. «._.. .,„„ „_*_:_:: *i.- _:» > .; . z .^ »,. _ . . . . _ • .• . .
TABLE I-9.—REQUIRED REGULATORY
DETECTION LIMITS FOR THE VAR-
IOUS RADIOCHEMICAL CONTAMI-
NANTS (§141.25)
logical Survey, 1977; Available at U.S. Geological Survey Information Services, Box 25286. Federal Center Denver CO 80225-SJ2
10014^3621OCedUSeS Manual"' 27th Edition' Volume 1,1990. Available at the Environmental Measurements Laboratory, U.S. Departrhefi Energy (DOE), 376 Hudson Street. New York, NY
partrSfnt of Health °EmP1r|2|tatedplS2AlDan'0N)Y' 12201 ^ 19M: Revise«iia=.y«uvis
the distribution system, beginning
within one quarter after being notified
by the State. Systems already designated
by the State must continue to sample
until the State reviews and either
reaffirms or removes the designation. If
the gross beta particle activity minus the
naturally occurring potassium-40 beta
particle activity at a sampling point has
a running annual average less than or
equal to 50 pCi/L (screening level), the
system may reduce the frequency of
monitoring at that sampling point to
once every 3 years.
Community water systems (both
surface and ground water) designated by
the State as utilizing waters
contaminated by effluents from nuclear
facilities must collect quarterly samples
for beta emitters and iodine-131 and
annual samples for tritium and
strontium-90 at each entry point to the
distribution system, beginning within
one quarter after being notified by the
State. Systems already designated by the
State as systems using waters
contaminated by effluents from nuclear
facilities must continue to sample until
the State reviews and either reaffirms or
removes the designation. If the gross
Contaminant
Gross Alpha
Gross Beta ....
Radium-226
Radium-228
Cesium-1 34
Strontium-89
Strontium-90
lodine-131
Tritium
Other Radionuclides and Pho-
ton/Gamma Emitters.
Detection
Limit
(pCi/L)
3
4
1
1
10
10
2
1
1 000
Viothofthe
rule.
/. Where and How Often Must a Water
System Test for Radionuclides?
1. Monitoring Frequency for Gross
Alpha, Radium 226, Radium 228, and
Uranium
The monitoring scheme being
finalized today provides for more
frequent, but less sample-intensive (on a
per compliance site basis), monitoring
for systems with a demonstrated .
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76726 Federal Register/Vol. 65, No. 236/Thursday, December 7, 2000/Rules and Regulations
beta particle activity beta minus the
naturally occurring potassium-40 beta
particle activity at a sampling point has
a running annual average less than or
equal to 15 pCi/L (screening level), the
system may reduce the frequency of
monitoring at that sampling point to
every 3 years.
For CWS in the vicinity of a nuclear
facility, the State may allow the CWS to
utilize environmental surveillance data
collected by the nuclear facility in lieu
of monitoring at the system's entry
pointfs), where the State determines if
such data is applicable to a particular
water system. Community water
systems designated by the State to
monitor for beta particle and photon
radioactivity can not apply to the State
for a waiver from the monitoring
frequencies.
Several USGS studies, including the
study entitled Gross-beta Activity in •
Ground Water: Natural Sources and
Artifacts of Sampling and Laboratory
Analysis, have found that Potassium-40
and Radium-228 appear to be the
primary sources of beta activity in
ground water. EPA recognizes that
naturally occurring potassium could
trigger many systems into conducting
expensive beta speciation analysis due
to exceedance of the screening level.
Therefore, as noted above, naturally
occurring Potassium-40 analyzed from
the same or equivalent sample used for
the gross beta analysis may be
subtracted from the total gross beta
activity to determine if the screening
level is exceeded. The potassium-40
beta particle activity must be calculated
by multiplying elemental potassium
concentrations (in mg/L) by a factor of
0.82. If the gross beta particle activity
minus the naturally occurring
potassium-40 beta particle activity
exceeds the screening level, an analysis
of the sample must be performed to .
identify the major radioactive
constituents present in the sample and
the appropriate doses must be
calculated and summed to determine
compliance xvith § 141.66(d). Doses
must also be calculated and combined
for measured levels of tritium and
strontium to determine compliance.
The regulatory language in
§ 141.26(b)(6) of today's rule requires
systems to monitor monthly at sampling
points which exceed the maximum
contaminant levels in § I41.66(d)
beginning in the next month after the
exceedance occurred. There are many
circumstances that may arise from this
requirement such as collecting and
obtaining the results in two separate
months, however, the EPA intended this
to require all systems to collect the
initial monthly sample no later than 30
days following the collection date of the
initial MCL exceedance.
The EPA believes that States have
evaluated the vulnerability of systems to
potential beta emitting sources under
the existing rule. Therefore, States
should use the existing vulnerability
assessments to notify systems of their
status and monitoring requirements if
they have not provided that notification
previously. The EPA is also encouraging
States to reevaluate a systems
vulnerability to beta photon emitting
sources when conducting a systems
source water assessment and provide
immediate notification to those systems
that have been deemed vulnerable.
3. Sampling Points and Data
Grandfathering
Because the current radionuclide
NPDWRs have been in effect for almost
25 years, States have much historical
distribution system data for the
regulated radionuclides at most
community water systems and have data
regarding occurrence patterns at various
scales. The monitoring scheme is an
attempt to balance two opposing goals:
first, to ensure that every entry point is
in compliance, and second, to allow
States and drinking water systems to
make maximal use of the existing
distribution system historical data.
To meet the first goal, today's final
rule requires that all new monitoring be
at the entry point to the distribution
system. This will ensure that all entry
points are in compliance with the MCLs
from now on. But, rather than narrowly
prescribing specific criteria for
grandfathering existing distribution
system data, today's rule provides
flexibility to States to devise a
grandfathering plan applicable to their
own circumstances. In particular, States
may devise a plan for determining
which systems will need to analyze new
samples from each entry point to
establish initial monitoring baselines for
the currently regulated radionuclides
and which can rely on the existing
distribution system data for the same
purpose (including existing uranium
data). EPA had considered more
prescriptive options, such as allowing
grandfathering for systems with fewer
than three entry points, systems serving
fewer than 3,300 persons, systems
drawing from aquifers of certain
characteristics, etc. However, the many
competing variables present at the local
level make generalizations impractical
at the national level. Since the
grandfathering plans will be a part of
the primacy packages approved by the
EPA Regions, EPA will have oversight
over these plans. EPA expects that the
plans would allow grandfathering only
for situations in which it is to be
expected that every entry point is in
compliance with the MCLs. For
example, if a system with five entry
points (all of significant flows) has gross
alpha monitoring data from a
representative point in the distribution
system and the result is 75% of the MCL
(11 pCi/L), EPA expects that this data
would not be grandfathered, since it can
not be ruled out that at least one of the
entry points has a contaminant level
greater than the MCL. On the other
hand, if the distribution system sample
baseline result is below the detection
limit and the State determines that,
based on aquifer and other
characteristics, the entry points are
expected to have fairly uniform
contaminant levels, then a State could
reasonably determine that this water
system should be able to grandfather its
distribution system data. EPA will
provide an Implementation Guidance to
further explain this issue after today's
rule is final.
4. Does the Rule Allow Compositing of
Samples?
Compositing allows a system to have
combined samples analyzed to reduce
the costs of monitoring. Compositing of
samples is done in the laboratory. The
1976 rule allowed compositing for gross
alpha and allowed (but did not
recommend) some compositing for beta/
photon emitters. Compositing is
essentially an issue for the initial round
of monitoring for systems without data •
to grandfather. Once decreased
monitoring is in effect, only a single
sample will be required and
compositing will not be an issue. In
general, there are three kinds of
compositing: combining samples taken
• from the same sampling point from
different quarters (temporal
compositing), samples taken in the same
quarter from different sampling points
within a system (spatial compositing),
and samples taken from different water
systems each having one well (inter-
system compositing). Inter-system and
spatial compositing are not allowed in
today's rule, since this kind of
compositing defeats the purpose of
monitoring at each entry point to the
distribution system.
Because compositing lessens the
burden on systems and allows for
adequate monitoring reliability in some
situations, temporal compositing is
allowed under circumstances in which
the detection limit is low compared to
the MCL. In particular, temporal
compositing is allowed for uranium,
gross alpha radium-226 (provided a DL
of 1 pCi/L is met) and radium-228
(provided a DL of 1 pCi/L is met). While
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Federal Register /Vol. 65, No. 236/Thursday, December 7, 2000/Rules and Regulations 76727
compositing is allowed under these
circumstances, compositing of several
samples taken at different times
provides less information than
individual analysis of the samples. For
example, if contaminant levels vary
appreciably with pumping rates and
pumping rates are seasonal, compositing
will hide this potentially significant
variance. Additionally, if a State allows
a system •with low contaminant levels to
base compliance on two results from
different quarters, compositing may not
be desirable. If a State wishes to be more
stringent and use the highest result of
four initial samples to set future
monitoring frequency, compositing is
not appropriate. However, under some
conditions, States may wish to allow
water systems to have their samples
composited before analysis.
Commenters generally agreed that
spatial monitoring was impractical,
since it would provide limited
information on contaminant levels at
individual entry points. Some
commenters suggested that the six
month holding time for gross alpha
would necessitate compositing twice,
two samples in the first six months and
two in the second six months. Although
this type of compositing would be
allowed, EPA disagrees that this is
necessary, since, for statistical reasons,
analysis of four composited samples
taken in four different quarters will
achieve results of comparable quality
(assuming that the analysis is done
within the same year that the first
sample is taken) to individual analyses
of four samples using six month holding
times. For this reason, annual
compositing at a single entry point is
allowed for gross alpha. While several
commenters were desirous of maximum
compositing flexibility, the technical
limitations described rule out some
types of compositing, specifically
spatial and inter-system compositing.
5. Interpretation of Analytical Results
The Agency recognizes that States
have interpreted radionuclide analytical
results in a variety of ways, including
adding or subtracting standard
deviations from the analytical results.
The Agency believes that compliance
and reduced monitoring frequencies
should be calculated based on the
"analytical result(s)" as stated in
§ 141.26(c)(3). It is EPA's interpretation
that the analytical result is the number
that the laboratory reports, not
including (i.e. not adding or subtracting)
the standard deviation. For example, if
a laboratory reports that the gross alpha
measurement for a sampling point is 7
± 2 pCi/L, then compliance and reduced
monitoring would be calculated using a
value of 7 pCi/L.
K. Can My Water System Use Point-of-
Use (POU), Point-of-Entiy (POE)10, or
Bottled Water To Comply With This
Regulation?
EPA has listed: (1) POU ion exchange
and POU reverse osmosis as small
system compliance technologies for
combined radium-226 and radium-228,
and beta particle and photon
radioactivity; and (2) POU reverse
osmosis as a small systems compliance
technology for gross alpha particle
activity (63 FR 42032; on August 6,
1998, also see Table 1-6 and 1-7)). While
these POU technologies are not
considered BAT for large systems, they
may be used as BAT under sections
1412 and 1415 of the Act for systems
serving 10,000 persons or fewer.
Guidance documents were published to
support the small systems compliance
technology lists ("Small System
Compliance Technology List for the
Non-Microbial Contaminants Regulated
Before 1996," USEPA 1998f). The small
system compliance technology list
described in section I.H., table 1-6, of
today's final rule is identical to the 1998
list, with the exception of the addition
of small systems compliance
technologies for uranium. See section
I.H. for details about the lists. POE
technologies are not being listed as
small systems compliance technologies
since they are considered emerging
technologies and due to concerns
regarding waste disposal and costs. POE
technologies (and other technologies)
may be added in the future through
small system compliance technology
updates.
The authority for listing POU
technologies as small system
compliance technologies comes from
section 1412(b)(4)(e)(ii) of the SDWA,
which identifies both Point-of-Entry
(POE) and Point-of-Use (POU) treatment
units as options for compliance
technologies. The SDWA identifies
requirements that must be met when
POU or POE units are used by a water
system to comply with an NPDWR.
Section 1412(b)(4)(e)(ii) stipulates that
"point-of-entry and point-of-use
treatment units shall be owned,
10 Point-of-entry (POE) treatment units treat all of
the water entering a household or other building,
with the result being treated water from any tap.
Point-of-use (POU) treatment units treat only the
water at a particular tap or faucet, with the result
being treated water at that one tap, with the other
taps serving untreated water. POE and POU
treatment units often use the same technological
concepts employed in the analogous central
treatment processes, the main difference being the
much smaller scale of the device itself and the
flows being treated.
controlled, and maintained by the
public water system or by a person
under contract with the public water
system to ensure proper operation and
maintenance and compliance with the
MCL or treatment technique and
equipped with mechanical warnings to
ensure that customers are automatically
notified of operational problems." Other
conditions in this section of the SDWA
include the following: "If the American
National Standards Institute has issued
product standards applicable to a
specific type of POE or POU treatment
unit, individual units of that type shall
not be accepted for compliance with a
MCL or treatment technique unless they
are independently certified in
accordance with such standards."
In order to list POU treatment units as
compliance technologies, EPA had to
withdraw the part of § 141.101 that
prohibited POU devices being used to
comply with an MCL. To this end, a
final rule was published in the Federal
Register on June 11, 1998 (EPA 1998g).
For more details on POU and POE
devices, see the supporting guidance
document for the small system
compliance technology lists (USEPA
1998f).
Public water systems are not allowed
to use bottled water to comply with an
MCL (63 FR 31932; June 11,1998).
Bottled water may only be used on a
temporary basis to avoid unreasonable
risks to health, e.g., as negotiated with
the State or other primacy agency as
part of the compliance schedule period
for an exemption or variance.
L. What Do I Need To Tell My
Customers?
1. Consumer Confidence Reports
On August 19,1998, EPA issued
Subpart O, the final rule requiring
community water systems to provide
annual reports on the quality of water
delivered to their customers (63 FR
44512). The first Consumer Confidence
Reports (CCRs) were to be made
available to customers by October 19,
1999, and now they are due each year
by July 1 (§ 141.152(a)). In these reports,
systems must provide, among other
things, the levels and sources of all
detected contaminants and a description
of the potential health effects of any
contaminant found at levels that violate
EPA or State rules, as part of a broader
description of the violation and efforts
to remedy it. For MCL or treatment
technique violations, specific "health .
effects language" in Appendix A of
Subpart O must be included verbatim in
the report. Today's rule updates the
Appendix to include health effects
language and "likely source"
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76728 Federal Register/Vol. 65, No. 236/Thursday, December 7, 2000/Rules and Regulations
information for uranium. This language other radionuclides and with the health effects language required for the
is consistent both with previously language now required hy the Public radionuclides for the purposes of CCR
published health effects language for Notification Rule. Table 1-10 shows the and public notification.
TABLE 1-10.—STANDARD HEALTH EFFECTS LANGUAGE FOR CCR AND PUBLIC NOTIFICATION
Contaminant
Standard health effects language for CCR and public notification
Beta/photon emitters
Alpha Emitters
Combined Radium (-226 &-22S) .
Uranium
Certain minerals are radioactive and may emit forms of radiation known as photons and beta radiation.
Some people who drink water containing beta and photon emitters in excess of the MCL over many
years may have an increased risk of getting cancer. ,. . „ .
Certain minerals are radioactive and may emit a form of radiation known as alpha radiation. Some people
who drink water containing alpha emitters in excess of the MCL over many years may have an in-
creased risk of getting cancer.
Some people who drink water containing radium 226 or 228 in excess of the MCL over many years may
have an increased risk of getting cancer.
Some people who drink water containing uranium in excess of the MCL over many years may have an in-
creased risk of getting cancer and kidney toxicity.
2. Public Notification
Sections 1414(c)(l) and (c)(2) of the
SDWA, as amended in 1996, require
that public water systems notify then-
customers when they are in violation of
NPDVVRs. In the case of the
radionuclides NPDWRs, this only
applies to community water systems.
On May 4, 2000, EPA revised the
minimum requirements that public
xvater systems must meet for public
notification of violations of EPA's
drinking water standards and other
situations that pose a. risk to public
health from the drinking water. These
revisions were promulgated under the
Public Notification Rule (PNR), under
40 CFR Part 141, Subpart Q. Water
systems must begin to comply with the
new regulations on October 31,2000 (if
they are in jurisdictions where the
program is directly implemented by
EPA), or on the date a primacy State
adopts the new requirements (but not
later than May 6, 2002). Until the
effective date of the new requirements,
water systems must continue to comply
with the requirements under § 141.32.
Subsequent EPA drinking water
regulations that affect public
notification requirements will amend
the PNR as a part of each individual
rulemaking.
Public notification of drinking water
, violations is an important part of the
"public right to know" provisions of the
1996 Amendments to the Safe Drinking
Water Act. The PNR sets the
requirements that public water systems
must follow regarding the form, manner,
frequency, and content for public
notifications. These requirements apply
to owners and operators of, in the case
of the radionuclides NPDWRs,
community water systems. The PNR
requires that any regulated system
notify its customers when: (1) A
violation of a NPDWR occurs; (2) the
system obtains a variance or an
exemption from a NPDWR; or (3) the
system is facing another situation
Eosing a significant risk to public
ealth.
Depending on the severity of the
situation, water suppliers have from 24
hours to one year to notify their
customers after a violation occurs. EPA
specifies three categories, or tiers, of
public notification. Depending under
which tier a violation situation falls,
water systems have different amounts of
time to distribute and ways to deliver
the notice:
• Immediate Notice (Tier 1): Any time
a situation occurs where there is the
potential for human health to be
immediately impacted, water suppliers
have 24 hours to notify people who may
drink the water of the situation. Water
suppliers must use media outlets such
as television, radio, and newspapers,
post their notice in public places, or
personally deliver a notice to their
customers in these situations.
• Notice "as soon as possible" (Tier
2): Anytime a water system provides
water with levels of a contaminant that
exceed EPA or State standards or that
hasn't been treated properly, but that
does not pose an immediate risk to
human health, the water system must
notify its customers as soon as possible,
but within 30 days of the violation.
Notice may be provided via the media,
posting, or through the mail.
• Annual Notice (Tier 3): When water
systems violate a drinking water
standard that does not have a direct
impact on human health (for example,
failing to take a required sample on
time) the water supplier has up to a year
to provide a notice of this situation to
its customers. The extra time gives
water suppliers the opportunity to
consolidate these notices and send them
with annual water quality reports
(consumer confidence reports (CCR)), if
the CCR meets the PNR timing, content,
and distribution requirements.
The PNR lists the currently regulated
radionuclides (combined radium-226
and radium-228, gross alpha, and beta
particle and photon radioactivity) as
being subject to "Tier 2" public notice
requirements for MCL violations and
"Tier 3" public notice requirements for
violations of the monitoring and testing
procedure requirements. Today's rule
does not change this designation for the
currently regulated radionuclides and
adds uranium to the list of contaminants
subject to Tier 2 requirements for MCL
violations and Tier 3 requirements for
violations of the monitoring and testing
procedure requirements.
The elements to be included in each
public notice are specified under
§ 141.205(a). All notices must include:
• A description of the violation that
occurred, including the potential health
effects (as specified in appendix B to
subpart Q for MCL violations and the
standard language under § 141.205(d)(2)
for monitoring violations);
• The population at risk and if
alternate water supplies need to be
used;
• What the water system is doing to
correct the problem;
• Actions consumers can take;
• When the violation occurred and
when the system expects it to be
resolved;
• How to contact the water system for
more information; and
• Standard language encouraging
broader distribution of the notice.
The standard health effects language
used for public notification is the same
as that for CCR, which is provided in
Table 1-10.
The public notice requirements under
40 CFR 141.203(b)(l) are such that the
public water system must provide a Tier
2 public notice to persons served as
soon as practical, but no later than 30
days after the system learns of the
violation. Posted notices are required to
remain in place for as long as the
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Federal Register/Vol. 65, No. 236/Thursday, December 7, 2000/RuIes and Regulations
76729
violation or situation persists, but in no
case for less than seven days, even if the
violation or situation is resolved. The
PNR under § 141.203(b)(2) also requires
the public water system to repeat the
notice every three months for as long as
the violation persists. In contrast, the
current rule requires a newspaper notice
within 14 days, a notice mailed to all
bill-payers within forty-five days, and a
repeat notice mailed every three months
thereafter until the violation is resolved.
The public notification requirement
gives the primacy agency discretion, in
appropriate circumstances, to extend
the time period allowed for the Tier 2
notice from 30 days to up to three
months for the initial notice and to
allow repeat notice less frequently than
every three months (but no less than
once per year]. Permission must be
granted in writing. Although the
discretion given to the primacy agency
is fairly broad, the rule specifically
disallows extensions of the 30-day
deadline for the initial public notice for
any unresolved violation. The PNR also
does not allow primacy agencies to
establish regulations or policies that
automatically give "across-the-board"
extensions or reductions in the repeat
notice frequency for all the otter
violations.
For the most up-to-date version of the
OCR and PNR tables that will be
• published in the July edition of the
Code of Federal Regulations (appendix
A to subpart O, and appendices A and
B to subpart Q of 40 CFR part 141), visit
EPA's Office of Ground Water and
Drinking Water's website at "http://
www.epa.gov/safewater/tables.html."
These on-line tables incorporate
changes on an on-going basis.
, M. Can My Water System Get a Variance
or an Exemption From an MCL Under
Today's Rule?
There are two kinds of variances
applicable to public water systems:
"regular variances," which are usually
referred to simply as "variances," and
"small systems variances." The
currently regulated radionuclides are
already subject to the provisions for
variances and exemptions and nothing
in today's rule changes these provisions.
The regular variances and exemptions
provisions will be discussed later in this
section.
As discussed in the NODA, the
"Small Systems Compliance
Technology List" (SSCTL) for combined
radium-226 and -228, gross alpha
particle activity, and beta particle/
photon emitter radioactivity was
published in the Federal Register on
August 6, 1998 (63 FR 42032), as
required by the amended SDWA. The
SSCTL list for uranium was published
for comment in the radionuclides
NODA.
The 1996 SDWA identifies three
categories of small drinking water
systems, those serving populations
between 25-500, 501-3,300, and 3,301-
10,000. hi addition to BAT
determinations, the SDWA directs EPA
to make technology assessments for
each of the three small system size
categories in all future regulations
establishing an MCL or treatment
technique. Two classes of small systems
technologies are identified for future
NPDWRs: small system compliance
technologies and small system variance
technologies.
Small system compliance
technologies ("compliance
technologies") may be listed for
NPDWRs that promulgate MCLs or
treatment techniques. In the case of an
MCL, "compliance technology" refers to
a technology or other means that is
affordable for the appropriate small
systems (if applicable) and that achieves
compliance. Possible compliance
technologies include packaged or
modular systems and point-of-entry
(POE) or point-of-use (POU) treatment
units, as described previously.
Small system variance technologies
("variance technologies") are only
specified for those system size/source
water quality combinations for which
no technology meets all of the criteria
for listing as a compliance technology
(section 14l2(b)(l5)(A)). Thus, the
listing of a compliance technology for a
size category/source water combination
prohibits the listing of variance
technologies for that combination.
While variance technologies may not
achieve compliance with the MCL or
treatment technique requirement, they
must achieve the maximum reduction
that is affordable considering the size of
the system and the quality of the source
water. Variance technologies must also
achieve a level of contaminant
reduction that is "protective of public
health" (section 1412(b)(15)(B)). The
process for determining small system
compliance technologies and small
system variance technologies is
described in more detail in the guidance
document, "Small System Compliance
Technology List for the Non-Microbial
Contaminants Regulated Before 1996"
(USEPA 1998f).
In the case of the currently regulated
radionuclides, i.e., combined radium-
226 and -228, gross alpha particle
activity, and total beta particle and
photon radioactivity, there are no
variance technologies allowable since
the SDWA (section 1415(e)(6)(A))
specifically prohibits small system
variances for any MCL or treatment
technique which was promulgated prior
to January 1,1986. The Variance and
Exemption Rule describes EPA's
interpretation of this section in more
detail (see 63 FR 19442; April 20,1998).
Stakeholders provided input
regarding the small system compliance
technologies for combined radium-226
and -228, gross alpha emitters, and beta
particle and photon radioactivity, and
uranium that are listed in section I.H.
The small system compliance
technologies for the radionuclides
regulated since 1976 were listed and
described in the Federal Register on
August 6, 1998 (63 FR 42032) and in an
accompanying guidance manual (EPA
1998b). Small systems compliance
technologies for uranium were
evaluated subsequent to the 1998 list,
and presented in the Small Systems
Compliance Technology List for the
Radionuclides Rule (USEPA 1999a).
Small systems compliance technologies
for uranium were evaluated in terms of
each technology's removal capabilities,
contaminant concentration applicability
ranges, other water quality concerns,
treatment costs, and operational/
maintenance requirements. This list was
published for comment in the April 21,
2000, Notice of Data Availability
(USEPA 2000e). No comments were
received.
Small system compliance technology
lists are technology specific, but not
product (manufacturer) specific.
Product specific lists were determined
to be inappropriate due to the potential
resource intensiveness involved.
Information on specific products will be
available through another mechanism.
EPA's Office of Research and
Development has a pilot project under
the Environmental Technology
Verification (ETV) Program to provide
treatment system purchasers with
performance data from independent
third parties.
The currently regulated radionuclides
are already subject to the provisions for
"regular variances" and exemptions.
Uranium will be subject to the same
provisions. Variances generally allow a
system to provide drinking water that
may be above the maximum
contaminant level on the condition that
the quality of the drinking water is still
protective of public health. The SDWA
(I415(a)) requires that any system
obtaining a variance must enter into a
compliance schedule with the primacy
entity as a condition of the variance. An
exemption, on the other hand, is
intended to allow a system with
compelling circumstances an extension
of time before the system must comply
with applicable SDWA requirements.
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An exemption is limited to three years
after the otherwise applicable
compliance date, although, extensions
up to a total of six additional years may
be available to small systems under
certain conditions.
W. How Were Stakeholders Involved in
the Development of This Rule?
EPA has consulted -with a broad range
of stakeholders and technical experts.
EPA held a two-day stakeholders
meeting on the radionuclides rule in
Washington, DC on December 11-12,
1997. The meeting was announced in
the Federal Register and open to any
one interested in attending in person or
by phone. During the meeting, EPA
discussed a range of regulation
development issues with the
stakeholders, including the statutory
requirements, the stipulated agreement,
MCLs for each of the radionuclides, new
scientific information on health, effects,
occurrence, analytical methods,
treatment technologies, and the current
and proposed monitoring framework.
The presentations generated useful
discussion and provided feedback to
EPA regarding technical issues,
stakeholder concerns and possible
regulatory options. Participants in EPA's
stakeholder meeting included
representatives from the Association of
Metropolitan Water Agencies (AMWA),
Association of State Drinking Water
Administrators (ASDWA). American
Waterworks Association (AWWA),
National Association of Water
Companies, State departments of
environmental protection, State health
department, State drinking water
programs. Federal agencies,
environmental groups, and local water
systems. The public docket for this final
rulemaking contains the meeting
summary for EPA's stakeholder meeting
on radionuclides in drinking water.
In addition, during the regulation
development process, EPA gave
presentations on the radionuclides
regulation at meetings of the AWWA,
ASDWA and EPA State/Regional
conferences, and met with States from
Regions 2,3,7, and 8 regarding
radionuclides issues and the upcoming
final rule. EPA participated in AWWA's
Technical Advisory Workgroup (TAW),
which meets annually to discuss
technical issues including treatment,
occurrence, and health risks. State
public health departments and drinking
water program representatives of both
large and small drinking water districts
participated in TAW meetings. EPA also
held frequent conference calls xvith
interested State drinking water
programs about the development of the
rule. In addition, EPA made
presentations and received input at
Tribal meetings in Nevada, Alaska, and
California. Finally, EPA held a one-day
meeting with associations that represent
State, county, and local government
elected officials on May 30, 2000, and
discussed five upcoming drinking water
regulations, including radionuclides.
See section V.I "Executive Order 13132"
for more information about the meeting.
The Agency utilized the feedback
received from the stakeholders during
all these meetings in developing today's
final rule.
O. What Financial Assistance Is
Available for Complying With This
Rule?
Various Federal programs exist to
provide financial assistance to State,
local, and Tribal governments to
administer and comply with this and
other drinking water rules. The Federal
government provides funding to States
and Tribes that have a primary
enforcement responsibility for their
drinking water programs through the
Public Water Systems Supervision
(PWSS) Grants program. Additional
funding is available from other
programs administered either by EPA or
other Federal agencies. These include
the Drinking Water State Revolving
Fund (DWSRF) and Housing and Urban
Development's Community
Development Block Grant Program. For
example, the SDWA authorizes the
Administrator of the EPA to award
capitalization grants to States, which in
turn can provide low cost loans and
other types of assistance to eligible
public water systems. The DWSRF
assists public water systems with
financing the costs of infrastructure
needed to achieve or maintain
compliance with SDWA requirements.
Each State has considerable flexibility to
determine the design of its program and
to direct funding toward its most
pressing compliance and public health
protection needs. States may also, on a
matching basis, use up to ten percent of
their DWSRF allotments for each fiscal
year to assist in running the State
drinking water program.
Under PWSS Program Assistance
Grants, the Administrator may make
grants to States to carry out public water
system supervision programs. States
may use these funds to develop primacy
programs. States may "contract" with
other State agencies to assist in the
development or implementation of their
primacy program. However, States may
not use program assistance grant funds
to contract with regulated entities (i.e.,
water systems). PWSS Grants may be
used by States to set-up and administer
a State program which includes such
activities as: public education, testing,
training, technical assistance,
developing and administering a
remediation grant and loan or incentive
program (excludes the actual grant or
loan funds), or other regulatory or non-
regulatory measures.
P. How Are the Radionuclides MCLs
Used Under the Comprehensive
Environmental Response,
Compensation, and Liability Act
(CERCLA)?
The framework for the
Comprehensive Environmental
Response, Compensation, and Liability
Act (CERCLA) and the National Oil and
Hazardous Substances Pollution
Contingency Plan (NCP) includes the
expectation that contaminated ground
waters will be returned to beneficial
uses whenever practicable (see
§300.430(a)(l)(iii)(F)). Section 12l(d) of
CERCLA requires on-site remedial
actions to attain MCLGs and water
quality standards under CWA when
relevant and appropriate. The NCP
(§ 300.430(e)(2)(i)(B) and (C) clarify that
MCLs or non-zero MCLGs established
under SDWA will typically be
considered relevant and appropriate
cleanup levels for ground waters that
are a current or potential source of
drinking water.
EPA's guidance on complying with
these requirements are contained in an
EPA document entitled "Presumptive
Response Strategy and Ex-Situ
Treatment Technologies for
Contaminated Ground Water at CERCLA
Sites, Final Guidance," (October 1996.
OSWER Directive 9283.1-12). A
discussion of the flexibility of EPA's
guidance under CERCLA on the
attainment of drinking waters in ground
water is contained in section 2.6 "Areas
of Flexibility in Cleanup Approach" (pp
15-19) of the 1996 OSWER directive.
The discussion in the 1996 OSWER
directive regarding monitored natural
attenuation and determining beneficial
uses of groundwater has been updated
by the following EPA guidance
documents: (l) "Use of Monitored
Natural Attenuation at Superfund,
RCRA Corrective Action, and
Underground Storage Tank Sites" (April
1999. Final OSWER Directive 9200.4-
17P), and (2) "The Role of CSGWPPs in
EPA Remediation Programs" (April 4,
1997, OSWER Directive 9283.1-09).
Q. What Is the Effective Date and
Compliance Date for the Rule?
Much of today's rule will involve
retaining current elements of the
radionuclides NPDWR. Those portions
of the final rule that are unaffected by
the upcoming regulatory changes are
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already in effect. MCLs for gross alpha,
beta particle and photon radioactivity,
and combined radium-226 and -228 will
be unchanged and are already in effect.
Regarding water systems that are
currently out of compliance with the
existing NPDWRs for gross alpha,
combined radium-226 and -228, and/or
beta particle and photon radioactivity,
States with primacy and EPA will
renegotiate, as necessary, enforcement
actions that put systems on compliance
schedules as expeditiously as possible.
Under 'the Safe Drinking Water Act,
the final rule becomes effective three
years after promulgation December 8,
2003. Under the Standard Monitoring
Framework (SMF), systems usually have
three years to complete the initial
monitoring cycle of four consecutive
quarterly samples. In order to
synchronize the monitoring periods for
radionuclides with the Standardized
Monitoring Framework and alleviate
potential laboratory capacity problems,
the end of the initial monitoring period
will be December 31, 2007. EPA expects
that States will phase-in monitoring
over this period and determine
compliance upon completion of each
water system's initial monitoring
schedule. For example, the fraction of
water systems that begin monitoring in
the first year would have compliance
determinations made at the end of the
first year, based upon the average results
of the four quarterly samples. New
monitoring includes initial monitoring
for uranium, the new monitoring
requirements for radium-228, and new
initial monitoring under the
requirements for entry points. Data
grandfathering discretion for existing
monitoring data to determine future
monitoring schedules is discussed in
sections I.D and I.J. Combined radium-
226 and radium-228 MCL violations
which result from the new requirement
for separate radium-228 monitoring will
be treated as "new violations" and •will
be on the same schedule as other new
violations (e.g. uranium). Water systems
with existing monitoring data for
radium-228 and uranium that
demonstrate that they are not in
compliance with the MCL will be out of
compliance on the effective date of the
rule.
R. Has EPA Considered Laboratory
Approval/Certification and Laboratory
Capacity?
The ultimate effectiveness of the
approved regulations depends upon the
ability of laboratories to reliably analyze
contaminants at relatively low levels.
The Drinking Water Laboratory
Certification Program is intended to
ensure that approved drinking water
laboratories analyze regulated drinking
water contaminants within acceptable
limits of performance. The Certification
Program is managed through a
cooperative effort between EPA's Office
of Ground Water and Drinking Water
and the Office of Research and
Development. The program stipulates
that laboratories analyzing drinking
water compliance samples must be
certified by U.S. EPA or the State. The
program also requires that certified
laboratories must analyze Proficiency
Testing (PT) samples [formerly called
Performance Evaluation (PE) samples],
use approved methods and pass
periodic on-site audits.
1. Laboratory Approval/Certification
As discussed in the April 21, 2000
NOD A, EPA recently privatized the PT
program, including the Water Supply
(WS) studies. The decision to privatize
the PT studies programs was announced
in the Federal Register on June 12,1997
(62 FR 32112). The notice indicated that
in the future the EPA would issue
standards for the operation of the
program, while the National Institute of
Standards and Technology (NIST)
would develop standards for private
sector PT suppliers and would evaluate
and accredit PT suppliers. The private
sector would develop and manufacture
PT samples and conduct PT studies.
2. Laboratory Capacity: Laboratory
Certification and PT Studies
The availability of laboratories is also
dependent on laboratory certification
efforts in the individual States with
regulatory authority for their drinking
water programs. Until June of 1999, a
major component of many of these
certification programs was their
continued participation in the current
EPA Water Supply (WS) PT program. As
discussed previously, NIST is
administering the program to accredit a
provider for PT samples for
radionuclides. States also have the
option of approving their own PT
sample providers. The extent to which
the PT program will affect short-term
and long-term laboratory capacity for
radionuclides will be assessed after PT
providers are approved by NIST or the
States. However, EPA anticipates that
radionuclide PT samples will be
available in time to allow for laboratory
certification before compliance
monitoring is required.
3. Summary of Major Comments
Regarding Laboratory Capacity and EPA
Responses
In the April 21, 2000 NODA, the
Agency stated that it is difficult to
ascertain how.and if externalization of
the PT program will affect
radiochemical laboratory capacity and
the cost of radiochemical analyses. In
the absence of definitive information,
the Agency solicited public comments
on this subject. The Agency stated hi the
NODA that it recognized that PT
externalization may be an
implementation issue for at least three
reasons:
• The externalization of the
radionuclides PT studies program may
cause short-term disruption in
laboratory accreditation;
• Requiring NTNCWSs to monitor
under the Standard Monitoring
Framework will add approximately
20,000 systems to the universe of
systems that are already required to
monitor;
• And the radon rule will be
implemented at approximately the same
time as the radionuclides rule.
To alleviate potential laboratory
capacity problems that could result, the
Agency solicited comments on whether
or not to extend the initial monitoring
period to four years (instead of three
years). Of the 70 commenters who
provided comments on the
radionuclides NODA, 15 commented on
laboratory externalization and its related
issues. The major concerns raised by the
commenters and the Agency's responses
to them are provided below.
a. Laboratory Certification,
Availability of PT Samples and Costs of
PT Samples: Several commenters noted
there is currently no certification
process through which laboratories can
receive State certification for
radionuclide analyses due to the lack of
availability of PT samples. Some
commenters noted that only one PT
provider has volunteered to provide PT
samples for radionuclides and based on
their inquiries, PT sample costs are too
high. Commenters believe the high costs
of PT samples will affect the resulting
costs of the radiochemical analyses (by
increasing operational costs). Several
commenters felt EPA should reconsider
the privatization of PT program.
Commenters stated that EPA must
ensure that an adequate number of
laboratories are available to perform
accurate measurements and provide
data of good quality for compliance and
enforcement efforts.
After evaluating public comment,
EPA published its final decision about
the externalization of the PT Program in
the June 12, 1997 final notice (62 FR
32112). Currently, the PT program for
radionuclides is being privatized, i.e.,
operated by an independent third party
provider accredited by the National
Institute of Standards and Technology
(NIST). EPA believes this program will
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76732 Federal Register/Vol. 65, No. 236/Thursday, December 7, 2000/Rules and Regulations
ensure the continued viability of the
existing FT programs, with EPA
maintaining oversight. NIST is in the
process of approving a provider for PT
samples for radionuclides. To alleviate
concerns about the costs of PT samples,
States have the option to approve PT
sample provider(s) themselves. The
Agency anticipates that radionuclide PT
samples will be available in time to
allow for laboratory certification before
compliance monitoring is required.
b. laboratory Capacity: Commenters
stressed the impact that the
extornalization of the PT program, this
regulation and the radon regulation
would have on laboratory capacity and
workloads of the laboratories. Some
commenters felt the externalization and
high costs of PT samples would
decrease the number of radiochemical
laboratories and in affect decrease
laboratory capacity. Also, commenters
felt that if EPA required 48-72 hour turn
around times for gross alpha (to catch
the alpha particle contribution from
radium-224) or monitoring of regulated
radionuclides by NTNCWSs,
radiochemical laboratories would not be
able to address the additional demand
for analytical services. EPA agrees that
laboratory capacity could be effected by
the externalization of the PT program. In
an effort to alleviate potential laboratory
capacity problems, EPA has agreed to
extend the initial monitoring period
from three to four years. Extending the
initial monitoring period will spread the
burden on the laboratories as well as the
costs associated with the monitoring. In
addition, EPA is allowing systems to
grandfather existing data on currently
regulated radionuclides and composite
under certain circumstances (for more
information on compositing and
grandfathering, see section I.J. In
addition, because EPA has decided not
to require a 48 to 72 hour turn around
time for gross alpha particle activity nor
to regulate NTNCWSs, the potential
burden on laboratory capacity should be
alleviated.
n. Statutory Authority and Regulatory
Background
A. What Is the Legal Authority for
Setting National Primary Drinking
Water Regulations (NPDWRs)?
The SDVVA requires EPA to
promulgate regulations pertaining to
public water systems. Specifically,
section 1412(b)(4) requires that EPA set
a health-based goal called a maximum
contaminant level goal (MCLG) as a
target for setting an enforceable
standard, the maximum contaminant
level (MCL). The MCLG is determined
by studies of the health effects of
contaminants on animals under
laboratory conditions or humans via
epidemiological studies. The MCLG is
the level at which no known or
anticipated adverse effects on the health
of persons occur and which allows an
adequate margin of safety. The Safe
Drinking Water Act requires EPA to set
the MCL as close to the MCLG as is
"feasible," which is defined as "feasible
with the use of the best technology,
treatment techniques and other means
which the Administrator finds, after
examination for efficacy under field
conditions and not solely under
laboratory conditions, are available
(taking cost into consideration) * * *"
[section 1412(b)(4)(D)]. Additionally,
section 1412(b)(6) provides that if the
Administrator determines that at the
feasible level, the benefits do not justify
the costs, EPA can set a standard which
maximizes the health risk reduction
benefits at a cost that is justified by the
benefits. In today's rule, EPA is
invoking these authorities with respect
to the uranium standard. Section 1412
(b)(9) requires that any revisions to
NPDWRs maintain or provide for greater
protection of the health of persons.
B. Is EPA Required To Finalize the 1991
Radionuclides Proposal?
The SDWA requires that EPA issue
MCLGs for the currently regulated
radionuclides in drinking water and
establish a NPDWR for uranium. When
EPA failed to finalize the 1991 proposal,
a citizen group brought suit to establish
a schedule for finalizing the appropriate
portions of the proposal. Following the
1996 amendments to the SDWA, the
plaintiffs and EPA agreed on a schedule
for completing the revisions to the
radionuclides rulemaking by either
finalizing applicable parts of the 1991
proposal or affirming the validity of the
current rule with an explanation of why
the current rule is preferable. With
respect to uranium, EPA has no current
rule, and is required to finalize a
uranium regulation on the same
schedule as gross alpha particle activity,
combined radium-226 and -228, and
beta particle and photon radioactivity.
This agreement was reflected in a
stipulation of the parties in litigation in
U.S. District Court in Oregon.
m. Rule Implementation
A. What Are the Requirements for
Primacy?
This section describes the regulations
and other procedures and policies
primacy entities have to adopt, or have
in place, to implement today's final
rule. States must continue to meet all
other conditions of primacy in 40 CFR
part 142.
Section 1413 of the SDWA establishes
requirements that primacy entities
(States or Indian Tribes) must meet to
maintain primary enforcement
responsibility (primacy) for its public
water systems. These include:
(1) Adopting drinking water
regulations that are no less stringent
than Federal NPDWRs in effect under
sections 1412(a) and 1412(b) of the Act,
(2) Adopting and implementing
adequate procedures for enforcement,
(3) Keeping records and making
reports available on activities that EPA
requires by regulation,
(4) Issuing variances and exemptions
(if allowed by the State) under
conditions no less stringent than
allowed by sections 1415 and 1416, and
(5) Adopting and being capable of
implementing an adequate plan for the
provision of safe drinking water under
emergency situations.
40 CFR part 142 sets out the specific
program implementation requirements
for States to obtain primacy for the
Public Water Supply Supervision
Program, as authorized under section
1413 of the Act. In addition to adopting
the basic primacy requirements, States
may be required to adopt special
primacy provisions pertaining to a
specific regulation. These regulation-
specific provisions may be necessary
where implementation of the NPDWR
involves activities beyond those in the
generic rule. States are required by
§ 142.12 to include these regulation-
specific provisions in an application for
approval of their program revisions.
These State primacy requirements apply
to today's final rule, along with the
special primacy requirements discussed
To implement today's final rule,
States are required to adopt revisions to
§ 141.25 — Analytical methods for
radioactivity; § 141.26 — Monitoring
frequency and compliance requirements
for radioactivity in community water
systems; appendix A to subpart O —
Regulated contaminants; appendix A to
subpart Q— NPDWR violations and
other situations requiring public notice;
appendix B to subpart Q — Standard
health effects language for public
notification; §142.16 — Special primacy
requirements; and new requirements
§ 141.55 — Maximum contaminant level
goals for radionuclides; and § 141.66 —
Maximum contaminant levels for
radionuclides.
B. What Are the Special Primacy
Requirements?
In addition to adopting drinking water
regulations at least as stringent as the
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Federal Register/Vol. 65, No. 236/Thursday, December 7, 2000/Rules and Regulations 76733
Federal regulations listed above, EPA
requires that States adopt certain
additional provisions related to this
regulation to have their program
revision application approved by EPA.
The State's request for approval must
contain the following:
(l) If a State chooses to use
grandfathered data in the manner
described in § 141.26(a)(2)(ii)(C) of this
chapter, then the State must describe
the procedures and criteria which it will
use to make these determinations
(whether distribution system or entry
point sampling points are used).
(i) The decision criteria that the State
will use to determine that data collected
in the distribution system are
representative of the drinking water
supplied from each entry point to the
distribution system. These
determinations must consider:
(A) All previous monitoring data.
(B) The variation in reported activity
levels.
(C) Other factors affecting the
representativeness of the data (e.g.
geology).
(2) A monitoring plan by which the
State will assure all systems complete
the required monitoring within the
regulatory deadlines. States may update
their existing monitoring plan or use the
same monitoring plan submitted for the
requirements in § 142.16(e)(5) under the
National Primary Drinking Water
Regulations for the inorganic and
organic contaminants (i.e. the Phase HI
V Rules). States may note in their
application any revision to an existing
monitoring plan or note that the same
monitoring plan will be used. The State
must demonstrate that the monitoring
plan is enforceable under State law.
There are many ways that a State may
satisfy the special primacy
requirements. The Agency intends to
issue guidance regarding ways to satisfy
these requirements, but States have the
flexibility to develop individual
programs appropriate for the
circumstances within each State.
C. What Are the Requirements for
Record Keeping?
The current regulations in § 142.14
require States with primacy
enforcement responsibility to keep
records of analytical results to
determine compliance, system
inventories, sanitary surveys, State
approvals, vulnerability determinations,
monitoring requirements, monitoring
frequency decisions, enforcement
actions, and the issuance of variances
and exemptions. These records include:
(1) Any determination of a system's
vulnerability to contamination by beta
and photon emitters (§ 142.14(d)(4));
and
(2) Any determination that a system
can reduce or increase monitoring
frequency for gross alpha particle
activity, gross beta particle and photon
radioactivity, uranium, radium-226 and
228. The records must include the basis
for the decision, and the repeat
monitoring frequency (§ 142.14(d)(5)).
Since these requirements are,',,
generally included in § 142.l4(d)(4) and
(5), revisions to the rule are not
necessary.
D. What Are the Requirements for
Reporting?
Currently, States must report to EPA
information under § 142.15 regarding
violations, variances and exemptions,
enforcement actions and general
operations of State public water supply
programs. These reporting requirements
remain unchanged and apply to the
radionuclides as with any other
regulated contaminant.
E. When Does a State Have To Apply for
Primacy?
The State must submit a request for
approval of program revisions that
adopts the uranium MCL, implementing
regulations, and other revisions
promulgated hi today's final rulemaking
within two years of the publication date
of today's rule unless EPA approves an
extension per § 142.12(b). To maintain
primacy for the Public Water Supply
Supervision (PWSS) Program and to be
eligible for interim primacy enforcement
authority for future regulations, States
must adopt today's rule. Interim
primacy enforcement authority allows
States to implement and enforce
drinking water regulations once State
regulations are effective and the State
has submitted a complete and final
primacy revision application. To obtain
interim primacy, a State must have
primacy with respect to each existing
NPDWR. Under interim primacy
enforcement authority, States are
effectively considered to have primacy
during the period that EPA is reviewing
their primacy revision application.
F. What Are Tribes Required To Do
, Under This Regulation?
Currently, no federally recognized
Indian tribes have primacy to enforce
any of,the drinking water regulations.
EPA Regions implement the rules for all
Tribes under section 145l(a)(l) of
SDWA. Tribes would need to submit a
primacy application in order to have the
authority to implement the
radionuclides NPDWRs. Tribes with
primacy for drinking water programs are
eligible for grants and contract
assistance (section 1451(a)(3)). Tribes
are also eligible for grants under the
Drinking Water State Revolving Fund
Tribal set aside grant program
authorized by SDWA section 1452(i) for
public water system expenditures.
IV. Economic Analyses
Under Executive Order 12866,
Regulatory Planning and Review, EPA
must estimate the costs and benefits of
the finalized changes to the
Radionuclides NPDWRs and submit the
impact analysis to the Office of
Management and Budget (OMB) as part
of the rulemaking process. EPA has
prepared an Economic Analysis (USEPA
2000g) to comply with the requirements
of this Order. This section provides a
summary of the information from the
economic analysis regarding estimates
of the costs and benefits related to the
changes to the existing radionuclides
NPDWRs and the uranium NPDWR
being finalized today. The economic
analysis is an update to the Health Risk
Reduction and Cost Analysis (USEPA
2000f) announced in the NODA (USEPA
2000e) and summarized in the NODA's
Technical Support Document (USEPA
2000h). The updates to the economic
analysis reflect comments received on
the NODA. This section will not repeat
all of the material presented in the
NODA and in some cases will refer back
to that notice. Changes made in
response to comments will be
highlighted.
A. Estimates of Costs and Benefits for
Community Water Systems
Two requirements under today's rule
are expected to incur costs and benefits:
the adoption of the uranium MCL of 30
ug/L and the requirement for separate
monitoring of radium-228, which is
expected to result in additional systems
in violation of the combined radium-
226/-22S MCL of 5 pCi/L. EPA estimates
that these requirements will result in
annual compliance costs of $81 million
in 1999 dollars, with $25 million of this
annual cost being due to mitigation of
systems newly in violation of the
radium-226/-228 standard due to new
monitoring requirements, $51 million
due to mitigation of systems in violation
of a uranium MCL of 30 ug/L, $ 4.9
million due to monitoring and reporting
by CWSs, and $ 0.06 million due to new
implementation costs for States. While
these represent new compliance costs,
most water systems will experience
reduced compliance costs in the long-
term because of reduced monitoring
frequency for^systems with low
contaminant levels under the
Standardized Monitoring Framework.
The basis for these estimates, and
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76734 Federal Regjster/Vol. 65, No. 236/Thursday. December 7, 2000/Rules and Regulations
alternate cost estimates using different
assumptions are described later in this
section.
State implementation and CWS start
up costs are estimated to be S10 million
annually for the first three years. Of this
S10 million, approximately S 0.25
million are State start up costs with the
remainder being comprised by CWS
start up costs tUSEPA 2000d). Over the
first twenty-three year period, the
implementation costs for States and
CVVSs are estimated to be S 4.9 million
annually (included in the annual
compliance costs reported previously).
These costs include preparation of the
primacy application, training, planning,
and other compliance preparations, and
monitoring and reporting costs for
PWSs.
The treatment/non-treatment
compliance unit costs and national
costing assumptions used in the
Economic Analysis (USEPA 2000g) are
standard and are consistent with those
used for estimating the costs of
compliance the other recently proposed
drinking water rules. The updated
Technologies and Costs document
(USEPA 20001) provides unit capital
and "operations & maintenance" costs
for water treatment plants, including
residuals disposal costs. Typical model
small system treatment costs ranged
from S 0.25 to S 3 per kilogallon of
water treated, with associated annual
per household costs ranging from S20 to
S250, with the value depending upon
water system size and water quality.
Large system model unit costs ranged
from S0.17 to S 0.28 per kilogallon
treated, with associated annual per
household costs ranging from S14 to
S23.
For various reasons (see the NODA's
Technical Support Document for
details, USEPA 2000h), the estimate of
monetized benefits associated with
compliance of today's rule are more
uncertain than the costs estimates. In
the case of the requirement for separate
monitoring for radium-228, cancer risk
reduction benefits of S1.7 million
annually are expected. While the net
benefits for this monitoring change are
expected to be negative, this monitoring
change is essential for enforcing the
combined radium-226/-228 standard. In
the case of the uranium standard, the
benefits are difficult to monetize, since
the number of kidney toxicity cases
avoided cannot be estimated using
current risk models. For this reason, the
uranium kidney toxicity benefits are
considered to be "non-quantified
benefits" for this rule. As discussed in
detail in part D of section I ("Rationale
for the Final Uranium MCL"), we
consider iheso non-quantified kidney
benefits to be a significant part of this
assessment of costs and benefits.
The uranium cancer risk reduction
benefits are estimated to be $3 million
annually, which, we reiterate, do not
include the non-quantified kidney
toxicity risk reduction benefits. As
discussed in the NODA, there are
significant uncertainties associated with
any estimate of drinking water benefits,
including uncertainties in the unit risks
used to estimate risk reductions and the
various health endpoints that cannot yet
be fully quantified. •
Other non-quantified benefits include
those related to the technologies used to
remove radium and uranium from
ground water (e.g., water softening
technologies like ion exchange, lime
softening, and membrane softening and
iron removal technologies like green
sand filtration and oxidation/filtration).
EPA does not have enough information
to estimate these benefits, but believes
that they could be significant. Examples
of benefits related to water softening
include reductions in excessive calcium
and manganese carbonate scaling in
distribution systems, water heaters, and
boilers and reductions in soap and
detergent use. Examples of benefits
related to iron removal include
improvements in color and taste and
reduction in staining of clothes, sinks,
and basins.
B. Background
1. Overview of the 1991 Economic
Analysis
Many of the options proposed in 1991
economic analysis are not being
finalized today. Today's discussion will
focus on the analysis of costs and
benefits of the options that are being
finalized: a final uranium standard and
separate monitoring for radium-228. The
1991 economic analysis (USEPA 1991)
estimated the annual cost of compliance
with a uranium MCL of 20 ug/L to be
555 million, affecting approximately
1,500 systems, the vast majority of them
being small systems. The 1991 estimate
of the annual cost of compliance with a
uranium MCL of 40 ug/L was $23
million. The current estimate of the cost
of compliance with a uranium MCL of
20 ug/L is S93 million, impacting 900
systems, most of them small.
2. Summary of the Current Estimates of
Risk Reductions, Benefits, and Costs
Table IV-1 shows the summarized
results for EPA's analysis of risk
reductions, benefits valuations, and
costs of compliance (see USEPA 2000g
for more detailed break-downs of the
risk reductions, costs, and benefits by
system size). The risk reductions and
cost estimates are based on the
estimated range of numbers of
community water systems predicted to
be out of compliance with the uranium
MCL of 30 ug/L and the systems that are
predicted to be out of compliance with
the current combined radium-226/-228
standard of 5 pCi/L because of the new
requirement for separate radium-228
monitoring. The best estimate values
shown are the midpoints from ranges
that are based on the two occurrence
model methodologies described in the
NODA (USEPA 2000e), the "direct
proportions" and "lognonnal model"
approaches. As described in the NODA,
these two approaches are expected to
serve as "low-end" and "high-end"
occurrence estimates, respectively.
Eliminating the combined radium-
226/-22S monitoring deficiency11 is
predicted to lead to 295 (range of 270 to
320) systems out of compliance with an
MCL of 5 pCi/L, affecting 420,000
persons (range 380,000 to 460,000). A
uranium MCL of 30 ug/L is predicted to
impact 500 systems (range 400 to 590),
affecting 620,000 persons (range 130,000
to 1,100,000). The estimates of .
occurrence and risk reductions for a
uranium MCL of 30 ug/L are based on
the assumption that the activity-to-mass
ratio in drinking water is 0.9 ptf/iuj.
Based on the available information, the
average activity-to-mass ratio for the
various uranium isotopes in drinking
water typically varies from 0.7 to 1.5
pCi/ug.
The estimated cancer morbidity risk
reduction for the option addressing the
combined radium monitoring deficiency
is 0.4 (0.3 to 0.5) cancer cases avoided
annually, with an associated annual
monetized benefit of S1.7 million (range
of SI.2 to S2.2 million). The annual
cancer morbidity risk reduction
estimated for a uranium MCL of 30 Ug/
L is 0.9 cases/year (range 0.1 to 1.6). The
associated annual monetized benefit
related to uranium cancer risk reduction
is S3 million (range from S0.2 to $6
million)IZ. The risk reductions and
"The monitoring deficiency is corrected by
requiring the separate analysis of radium-228 for
systems with gross alpha levels below S pCi/L and
radium-226 levels below 3 pCi/L.
"The Agency has agreed to consider the July 27,
2000 recommendations of its Science Advisory
Board (SAB) concerning discounting of benefits in
future drinking water regulations. In particular, the
SAB recommended that quantitative adjustments to
benefits be considered with respect to timing of risk
(e.g., consideration of a lag or latency period before
the resulting cancer fatality) and income growth.
The SAB also recommended that other possible
adjustments to benefits estimates be considered in
a qualitative manner. We have not made any such
adjustments to the benefits associated with today's
rule since the principal benefits are non-
quantifiable (avoidance of kidney toxicity due to
reductions in exposure to uranium). We do not
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Federal Register/Vol. 65, No. 236/Thursday, December 7, 2000/Rules and Regulations 76735
benefits shown for uranium do not
include those related to kidney toxicity,
which are non-quantifiable (cases
avoided cannot be estimated]. As
discussed in section I.D.2 of today's
final rule, these non-quantifiable
benefits are projected to be preventing a
series of adverse affects on the
functioning of the kidney such as
proteinuria (e.g., reabsorption
deficiency or leakage of albumin), that
could ultimately lead to a more
widespread breakdown in kidney
tubular function. Such effects on tubular
function would be manifested by an
impaired ability of the kidneys to filter
and reabsorb nutrients and to excrete
urine.
Annual compliance costs are
estimated to be $25 million (range $16
to $35 million) for the option addressing
the combined radium monitoring
deficiencies. Annual compliance costs
for the uranium NPDWR are predicted
to be $51 million (range from $9 to $92
million). In addition to these mitigation
related compliance costs, water systems
are expected to incur $4.9 million
annually in monitoring and reporting
costs. As demonstrated by this analysis
the estimated range of central-tendency
annual compliance costs exceed the
ranges of central-tendency annual
monetized benefits for both provisions
finalized today.
TABLE IV-1.—SUMMARY OF COSTS AND BENEFITS FOR COMMUNITY WATER SYSTEMS PREDICTED To BE IMPACTED BY
- . . • . THE REGULATORY OPTIONS BEING CONSIDERED FOR FINALIZATION
Options
Numbers of sys-
tems impacted 1
(population ex-
posed above MCL)
Estimated lifetime
radiogenic cancer
morbidity risk at
MCL1-3-* ;
Total cancer cases avoided
annually (fatal cases)
Best-estimate value of
avoided cancer cases, in
millions of
S/year)
, Best-estimate of
annual compli-
ance costs, in
millions of
S/year)
Systems predicted to be impacted by corrections to the monitoring deficiencies for combined radium-226 and -228
radium monitoring
deficiency.
K persons).
IxlO--1
04
(0.3)
1 7
25
Systems predicted to be out of compliance with proposed options for uranium MCL
• on i
K persons).
30 pCi/i.}.
09
(0.6)
(Total Number of kidney tox-
icity cases cannot be ac-
curately estimated, but ex-
pected to be substantial)
3 o
Kidney toxicity benefits
range from prevention of
mild proteinurea to pos-
sible more serious im-
paired kidney tubular func-
tion
51
Notes: Compliance costs do not include monitoring and reporting costs, which comprise an additional S5 million annually. Ranges based on
directly proportional versus lognormal distribution approach.
1 Compared to the initial baseline (i.e., occurrence data are adjusted to eliminate existing MCL violations) for combined radium. Occurrence
data is unadjusted for uranium options. ; . .
21x10 is equivalent to "one in ten thousand", EPA's usual upper limit of acceptable cancer incidence (morbidity) risk for contaminants in dnnk-
3These risk estimates are based on several simplifying assumptions and are only meant to be illustrative. The reported combined radium risk
is based on an "occurrence weighted average" for radium-226 and radium-228 (2.3x10-s per ppi/L). The "best-estimate" for a particular situa-
tion would depend on the actual levels of Radium226 and Radium228 that comprise the combined level of 5 pCi/L. Regarding uranium risks,
since the individual uranium isotopes that make up naturally-occurring uranium have cancer morbidity risks that are similar in magnitude (6.4 to
7.1X10--11 per pCi), the assumptions about isotopic prevalence are not important. Here, we assumed that the simple average applied (3.83x10-*
per pCi/L).
4 Kidney toxicity is not considered in this estimate of risk or monetized benefits.
3. Uncertainties in the Estimates of •
Benefits and Cost
The models used to estimate costs and
benefits related to regulatory measures
have uncertainty associated with the
model inputs. The types and
uncertainties of the various inputs and
the uncertainty analyses for risks,
benefits, and costs are qualitatively
discussed in this section.
a. Uncertainties in Risk Reduction and
Benefits Estimates
For each individual radionuclide,
EPA developed a central-tendency risk
coefficient that expresses the estimated
probability that cancer will result in an
exposed individual per unit of
radionuclide activity (e.g., per pCi/L)
over the individual's lifetime (assumed
to be 70 years). Two types of risks are
considered, cancer morbidity, which
refers to any incidence of cancer (fatal
or non-fatal), and cancer mortality,
which refers to a fatal cancer illness. For
this analysis, we used the draft
September 1999 risk coefficients
developed as part of EPA's revisions to
Federal Guidance Report 13 (FGR-13,
EPA 1999e). FGR-13 compiled the
results of several models predicting the
cancer risks associated with
radioactivity. The cancer sites
considered in these models include the
esophagus, stomach, colon, liver, lung,
bone, skin, breast, ovary, bladder.
kidney, thyroid, red marrow (leukemia),
as well as residual impacts on all
remaining cancer sites combined.
There are substantial uncertainties
associated with the risk coefficients in
FGR-13 (EPA 1999e): researchers
estimate that some of the coefficients
may change by a factor of more than 10
if plausible alternative models are used
to predict risks. While the report does
not bound the uncertainty for all
radionuclides, it estimates that the
central-tendency risk coefficients for
uranium-234 and radium-226 may
change by a factor of seven depending
on the models employed to estimate
believe that adjustments to these monetized cancer
avoidance benefits estimates for either timing or
income growth would materially affect our benefits
assessment or decisions resulting from overall
consideration of the benefits and costs of the
regulatory standard.
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76736 Federal Register/Vol. 65, No. 236/Thursday, December 7, 2000/Rules and Regulations
risk.13 Ranges that reflect uncertainty
and variability in the risk coefficients
have been used to conduct a sensitivity
analysis of risk reductions and benefits,
the results of which are reported in
Economics Analysis (USEPA 2000g).
Since the available occurrence data do
not provide information on the
contribution of individual radionuclides
or isotopes to the total activities of gross
alpha or uranium, there is uncertainty
involved in the assumptions about
isotopic ratios. These and other
uncertainties related to occurrence
information (e.g., uncertainty in
extending the NIRS database results to
the national level) also contribute to
uncertainty in the estimates of impacts.
Other inputs that were used in the
sensitivity analysis of risk reductions
and benefits are the age- and gender-
dependent distributions of water
ingestion, which are used in estimating
lifetime exposure, and the credible
range for the "value of a statistical life."
b. Uncertainty in Compliance Cost
Estimates
Regarding uncertainty in the
compliance cost estimates, these
estimates assume that most systems will
install treatment to comply with the
MCLs, while recent research suggests
that water systems usually select
compliance options like blending
(combining water from multiple
sources), developing new ground water
wells, and purchasing water (USEPA
2000g). As discussed in the NODA,
preliminary data (202 compliance
actions from 14 States) on nitrate
violations suggest that only around a
quarter (25%) of those systems taking
action in response to a nitrate violation
installed treatment, while roughly a
third developed a new well or wells.
The remainder either modified the
existing operations (10-15%), blended
(15%), or purchased water (15-20%).
Similar data for radium violations from
the State of Illinois (77 compliance
actions) indicate that around a quarter
of systems taking action installed
treatment, while the majority (50-55%)
purchased water, with, the remainder
(20-25%) either installing a new well,
blending, or stopping production from
the contaminated well or wells. EPA
will continue to gather information
regarding the prevalence of treatment
versus non-treatment options for
compliance for other contaminants. At
this time, this data is considered
preliminary and will be used for
comparisons only.
To evaluate the potential variability in
the compliance cost estimates, EPA has
performed a sensitivity analysis for
uncertainties in the decision tree by
varying the assumed percentages for the
modeled compliance options. Since per
system costs are much higher for very
large systems, the assumptions used in
the large water system size categories
can be expected to dominate the
variability in national costs. The
sensitivity analysis results are reported
in the Economic Analysis (USEPA
2000g).
4. Major Comments .
Following is a summary of the major
comments received on the analysis of
costs and benefits for the finalization of
the radionuclides rule.
a/Retention of radium-226/-228 MCL
of 5 pCi/L: Several commenters
suggested that the costs and benefits of
compliance with the existing radium-
226/-22S MCL should be included in the
analysis of the costs and benefits of the
finalization of today's rule, because
"systems currently in non-compliance
with the combined radium MCL are in
that situation because of EPA's
proposed rule changes in 1991." EPA
disagrees with this comment since all of
MCLs for the currently regulated
radionuclides, including radium-226/-
228 have been fully enforceable since
1976. While some may argue that the
radionuclides rules were "National
Interim Primary Drinking Water
Regulations" (NIPDWRs) between 1976
and 1986, NIPDWRs were fully
enforceable. In addition, six years
elapsed between the re-authorization of
the Safe Drinking Water Act (1986),
which finalized all NIPDWRs, and the
1991 proposal. Given the fact that 25
years have elapsed since this MCL
became an enforceable standard, EPA
believes that it is appropriate to
consider only the costs and benefits of
the changes that are being made in the
current standards. In view of the fact
that 25 years have elapsed since this
MCL became an enforceable standard,
EPA believes that is appropriate to
consider only the costs and benefits of
the changes that are made to the current
radium standards as a cost of today's
rule. EPA further believes that any costs
incurred by facilities that are required to
comply with the 1976 rule represent
deferred costs that those facilities
elected not to expend until now.14
"TobJo 2A. Uncertainty Categories for Selected
Risk Coefficient!, Federal Guidance Report 13
(ISM),
14 It is difficult to estimate these costs due to
recent efforts by many CWSs to comply with the
current radium rule, however, we would expect
approximately 200-400 systems would spend in the
range of S18-36 million annually to comply with
the current standard. (Low estimate in range is
b. Cost/Benefit Analysis
Requirements: One commenter
suggested that the analysis of costs and
benefits, as presented in the Notice of
Data Availability (USEPA_2000e)
omitted some information required
under section 1412(b)(4)(C) of the 1996
SDWA. EPA disagrees with this
comment. All of the required
information relevant to the analysis of
costs and benefits for the options
considered are found in the draft Health
Risk Reduction and Cost Analysis
(HRRCA, USEPA 2000f), which was
announced by and described in the
NODA. In the HRRCA, EPA did meet
the requirements of the Safe Drinking
Water Act. for performing analyses of
costs and benefits. For compliance with
each regulatory option being
considered, EPA updated the analysis
supporting the 1991 radionuclides
proposal, including estimates of
quantifiable and non-quantifiable health
risk reduction benefits, quantifiable and
non-quantifiable health risk reduction
benefits likely to occur from reductions
in co-occurring contaminants (excluding
those associated with compliance with
other proposed or promulgated
regulations), quantifiable and non-
quantifiable costs, the incremental costs
and benefits for the uranium options,
the effects of the contaminant on the
general population and on sensitive
groups within the population (e.g.,
children), and other relevant factors. In
addition to the HRRCA, EPA is
supporting today's final actions with a
Economic Analysis (USEPA 2000g) that
builds on the HRRCA, including some
changes made in response to comments
received.
c. Cumulative Affordability: Several
commenters suggested that EPA
consider the cumulative impact of its
regulations on the affordability of water
service, as opposed to looking at
affordability one regulation at a time.
EPA agrees that it would be best to look
at "cumulative affordability," since this
is the only realistic indicator of
affordability. For this reason, EPA
includes a "water bill baseline" in its
affordability assessments, which
includes cumulative impacts from
existing regulations. When a rule is
promulgated, the water bill baseline
increases and the estimate of
affordability decreases, the details of
which depend on the percentages of
systems impacted and the estimates of
the annual per household costs
associated with the regulation. The
affordability assessment supporting the
uranium small systems compliance
based on recent SDWIS data; high estimate is based
on 1984 NIRS occurrence database.)
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Federal Register/Vol. 65, No. 236/Thursday, December 7, 2000/Rules and Regulations 76737
technology list is based on the current
baseline, which is described in
"Variance Technology Findings for
Contaminants Regulated Before 1996",
which can be downloaded at "http://
wwwr.epa.gov/OGWDW/standard/
varfd.pdf." As future rules are
promulgated that impact small water
systems (including this one), this
baseline will be revised.
d. Disposal costs: One commenter
suggested that EPA "did not adequately
address the disposal of waste stream
residuals" in the NOD A and that waste
disposal costs are a "significant factor"
in estimating costs. EPA agrees that
waste disposal considerations are very
important when considering the
implementation of this rule. Since the
only MCL that EPA is finalizing today
is the uranium MCL (the others are
existing regulations), this is the only
MCL that could be impacted by this
consideration. In estimating the
compliance costs for today's actions,
EPA did include waste disposal costs in
its estimate of treatment costs, including
estimated waste-related capital costs,
operations and maintenance costs, and
residuals disposal. EPA believes that its
estimate of residuals disposal are
adequate and are based on the best
available information.
e. Discounting of Costs and Benefits:
One commenter stated that it is
"appropriate and standard practice to
ensure that costs and benefits be
evaluated on the same basis to avoid
apples and oranges comparison,"
further stating that EPA should discount
both or neither. EPA agrees that costs
and benefits should be evaluated in
such a way that they can be compared.
One approach to accomplish this is to
annualize the costs and benefits of the
regulation. In such instances, the capital
costs, paid up front, need to be spread
out across the life of the equipment. To
do that, one needs to reflect the time
value of resources. The analyst must ask
the question: What is the annual
payment that could finance the capital
investment? Such a calculation would
reflect the social discount rate. Annual
operations and maintenance (O&M)
costs would not have to be annualized,
since these costs are assumed to be
accrued on a continual basis each year.
Ideally, the analysis would also -
annualize the benefits using the same
techniques. As noted previously, we
have not made any such adjustments to
the benefits associated with today's rule
for uranium since the principal benefits
are non-quantifiable (avoidance of
kidney toxicity due to reductions in
exposure to uranium). We do not
believe that adjustments to these
benefits estimates for either timing or
income growth would materially affect
our benefits assessment or decisions
resulting from overall consideration of
the benefits and costs of the regulatory
standard.
f. Use of MCLs for Ground Water
Protection Needs to be Evaluated as Part
of this Rulemaking: One commenter .
stated that, since linkages are made
between drinking water standards and
"clean-up standards" for radioactively
contaminated sites, the costs and
benefits of applying drinking water
standards to clean-up efforts should be
evaluated as part of this rulemaking.
EPA disagrees that clean-up costs and
benefits should be used to influence the
setting of drinking water MCLs. EPA
does, however, agree that cross-program
costs and benefits should be considered
when appropriate. In this case, it is
inappropriate to consider clean-up and
ground water protection costs since
MCLs are set specifically and solely
with drinking water exposures in mind.
If another program or Agency applies
these MCLs for other purposes (e.g.,
clean-up standards), then the costs and
benefits of that application should be
considered when evaluating that
application.
V. Other Required Analyses and
Consultations •
A. Regulatory Flexibility Act (UFA)
The RFA, as amended by the Small
Business Regulatory Enforcement
Fairness Act of 1996 (SBREFA), 5 USC
601 et seq., generally requires an agency
to prepare a regulatory flexibility
analysis of any rule subject to notice
and comment rulemaking requirements
under the Administrative Procedure Act
or any other statute unless the agency
certifies that the rule will not have a
significant economic impact on a
substantial number of small entities.
Small entities include small businesses,
small organizations, and small
governmental jurisdictions.
The RFA provides default definitions
for each type of small entity. It also
authorizes an agency to use alternative
definitions for each category of small
entity, "which are appropriate to the
activities of the agency" after proposing
the alternative definition(s) in the
Federal Register and taking comment. 5
U.S.C. sec. 601(3)-(5). hi addition to the
above, to establish an alternative small
business definition, agencies must
consult with SBA's Chief Counsel for
Advocacy.
For purposes of assessing the impacts
of today's rule on small entities, EPA
considered small entities to be CWSs
serving fewer than 10,000 persons. This
is the cut-off level specified by Congress
in the 1996 Amendments to the Safe
Drinking Water Act for small system
flexibility provisions. Because this
definition does not correspond to the
definitions of "small" for small
businesses, governments, and non-profit
organizations, EPA requested comment
on an alternative definition of "small
entity" in the preamble to the proposed
Consumer Confidence Report (CCR)
regulation (63 FR 7620, February 13,
1998). Comments showed that
stakeholders support the proposed
alternative definition. EPA also
consulted with the Small Business .
Administration's Office of Advocacy on
the definition as it relates to small
business, analysis. In the preamble to the
final CCR regulation (63 FR 4511,
August 19, 1998), EPA expressed its
intention to use this alternative
definition for regulatory flexibility
assessments under the RFA for all
drinking water regulations and has thus
used it in this final rulemaking.
In accordance •with section 603 of the
RFA, EPA prepared an initial regulatory
flexibility analysis (IRFA) for the 1991
proposed rule (see 56 FR 33050). Since
the proposed rule (July 18, 1991) pre-
dated the 1996 Amendments to the
RFA, EPA did not convene a Small
Business Advocacy Review Panel for
this rule.
We also prepared a final regulatory
flexibility analysis (FRFA) for today's
final rule. The FRFA addresses the
issues raised by public comments on the
IRFA, which was part of the proposal of
this rule. The FRFA is available for
review in the docket and is summarized
below.
The RFA requires EPA to include the
following when completing an FRFA:
(1) A succinct statement of the need
for, and objectives of the rule;
(2) A summary of the significant
issues raised by the public comments on
the IRFA, and a summary of the
assessment of those issues, and a
statement of any changes made to the
proposed rule as a result of those
comments;
(3) A description of the types and
number of small entities to which the
rule will apply and the impact they will
experience, or an explanation why no
estimate is available;
(4) A description of reporting, record
keeping, and other compliance
requirements of the rule, including an
estimate of the classes of small entities
which will be subject to the rule and the
type of professional skills necessary for
preparation of reports or records; and
(5) A description of the steps the
Agency has taken to minimize the
significant impact on small entities
consistent with the stated objectives of
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76738 Fe'deral Register/Vol. 65, No. 236/Thursday, December 7, 2000/Rules and Regulations
the applicable statutes, including a
statement of the factual, policy, and
legal reasons why we selected the
chosen alternative in the final rule and
why the other significant alternatives to
the rule were rejected.
EPA has considered and addressed all
of the requirements. The following is a
summary of the FRFA. The need for and
objectives for the rule are discussed in
sections I.A, I.B, I.C and HA of this
preamble. Requirements "2" through
"4" are addressed in the subsections
that follow. The fifth requirement is
discussed in sections I.D and I.J., which
provide information about steps EPA
has taken that will lessen impacts on
small systems, including: (1) The
selection of the less stringent uranium
MCL, (2) overall reduced monitoring
frequencies for systems with
radionuclides levels less than the MCL,
(3) allowance of grandfathering of data
and State monitoring discretion for
determining initial monitoring baseline,
and (4) exclusion of NTNCWS from the
regulation. Sections I.C. and I.B provide
the rationale for the retention of the
MCLs for radium-226 and -228, gross
alpha, and photon/beta emitters.
The significant issues raised in public
comments were the high cost of
compliance for small systems and high
cumulative costs for water contaminant
testing. EPA understands these concerns
and has made several changes to the
proposed rule that will reduce cost
impacts to small systems. In addition,
commenters disagreed with the proposal
to include NTNC water systems in the
rule. Based on several factors, including
these comments and the analyses of
risks faced by NTNC customers, risk
reductions, benefits, and costs, EPA has
decided that additional future analyses
and reevaluation, together with any new
data that can be obtained is needed
before regulating radionuclides at NTNC
drinking water systems (see section
I.D.8. for further discussion]. This
information will be collected and future
regulatory action will be assessed under
the regulatory review process. A
complete summary of comments
received and EPA's responses can be
obtained from the docket (USEPA
2000a).
For many small entities, today's final
rule will reduce long-term monitoring
costs because the rule provides for less
frequent follow-up monitoring (relative
to the 1976 rule) for systems if they have
radionuclides levels (e.g., gross alpha
and radium-226 and -228) below the
MCLs (most small systems). For
example, under the 19,76 rule, a system
with a gross alpha level less than the
MCL but greater than V2 MCL is
required to monitor four times in a four
year period. The revised monitoring
scheme will allow this system to reduce
the monitoring frequency to one sample
every three years or less. In addition,
EPA is giving States discretion in using
historical monitoring data
(grandfathering) to determine the initial
monitoring baseline for systems.
Therefore, systems with sufficient data
may not be required to take four
quarterly samples for the initial
monitoring period and may immediately
begin reduced monitoring (e.g., one
sample per three years, six years, or
nine years) after the rule is effective
(e.g., three years after the rule is
promulgated). See sections ID "How
has this new information impacted the
regulatory decisions being promulgated
today?" and I.J "Where and how often
must a water system test for
radionuclides?" for additional
information about monitoring. A small
percentage (<1.5%) of systems are
expected to exceed the radium-226 and-
228 and uranium MCLs and will be
required to take action to come into
compliance. '
The number of small entities subject
to today's rule is shown in Table V-l.
TABLE V-1.—SUMMARY OF ANALYSIS RESULTS
From the "Economic Analysis of the Radionuclides NPDWR" (USEPA 2000g)
Commu-
nity
v.-alor
system
size
class
(25to
10.00)
Total
Ground water systems
Combined radium loop-
hole
Number of
systems
270-310
Cost/
Rev-
enue1
21-2
Uranium (20ng/L)
Number of
systems
820-900
Cost/
Rev-
enue1
21-3
Uranium (40 |ig/L)
Number of
systems
soo^too
Cost/
Rev-
enue1
21-3
Surface water systems
Uranium (20 ug/L)
Number of
systems
< 10-40
Cost/
Rev-
enue1
2 1-3
Uranium (40 jig/L)
Number of
systems
0-20
Cost/
Rev-
enue 1 .
' 2o_3"
Notes:
'As reported in the economic analysis support document (USEPA 2000g), the revenue portion of the cost per revenue estimates are based on
data collected the 1992 Census of Governments. The Agency then estimated average revenues for small governments.
The reported ranges represent results using the directly proportional approach followed by results using the lognormal distribution approach.
"0" indicates that no systems in this category are expected to be out of compliance with the MCL.
Revenue estimates are taken from Exhibit 6-3 of the economic analysis support document (USEPA 2000g).
See Appendix G of the economic analysis support document (USEPA 2000g) for information regarding the number of affected for the 25 to
10.000 size class and the associated costs. Detail does not add to totals due to rounding.
2 Percent.
Small systems are also required to
provide information in the Consumer
Confidence Report or other public
notification if the system exceeds one of
the MCLs. As is the case for other
contaminants, required information on
radionuclides levels must be provided
by affected systems and is not
considered to be confidential. The
professional skills necessary for
preparing reports are the same skill
level required by small systems for
current reporting and monitoring
requirements for other drinking water
standards.
In addition to the public comments on
the proposal, the Agency considered
comments received through an outreach
process that obtained input from small
entities, including a Stakeholders
meeting, Tribal consultations, and other
consultations. After considering all the
input from stakeholders as well as its
own analyses, the Agency has included
several measures in today's rule that
should reduce the burden on small
drinking water systems: (1) A revised
monitoring scheme with long-term
monitoring reduction for most small
systems; (2) State discretion for
grandfathering existing monitoring data;
(3) the decision not to regulate non-
transient, non-community water
systems, which are generally very small
water systems; and (4) the selection of
a uranium MCL that is less stringent
than the 1991 proposed feasible level.
The uranium MCL is still protective of
public health with an adequate margin
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Federal Register/Vol. 65, No. 236/Thursday, December 7, 2000/Rules and Regulations 76739
of safety, but will impact fewer small
systems, reducing the number of
systems that may face waste disposal
issues, and increasing the likelihood
that non-treatment options for achieving
compliance may be used. These items
are discussed in more detail in sections
• ID and I.J.
EPA also is preparing a small entity
compliance guide to help small entities
comply with this rule. Small entities
will be able to access a copy of this
guide at: http://www.epa.gov/sbrefa/ (to
be available within 60 days of the
publication of the rule in the Federal
Register).
B. Paperwork Reduction Act
The Office of Management and Budget
(OMB) has approved the information
collection requirements contained in
this rule under the provisions of the
Paperwork Reduction Act, 44 U.S.C.
3501 et seq. and has assigned OMB
control number—2040-0228
Under this rule, respondents to the
monitoring, reporting, and
recordkeeping requirements include the
owners and operators of community
water systems and State officials that
must report data to the Agencyi
Monitoring for radium-228, uranium,
and beta and photon emitters will be
required at each entry point to the
distribution system under the final
radionuclides rule. States will have
discretion in grandfathering existing
data for determining initial monitoring
baselines for the currently regulated
contaminants, combined radium-226/-
228, gross alpha particle activity, and
beta particle and photon radioactivity.
EPA has estimated the burden
associated with the specific information
collection, record keeping and reporting
requirements of the proposed rule in the
accompanying Information Collection
Request (ICR). The ICR for today's final
rule compares the current requirements
to the revised requirements for
information collection, reporting and
record-keeping. There are several
activities that the State and the CWSs
must perform in preparing to comply
with the revised Radionuclides Rule.
Start-up activities include reading the
final rule to become familiar with the
requirements and training staff to
perform the required activities.
For PWSs, the number of hours
required to perform each activity may
vary by system size. This rule only
applies to community water systems. As
shown in Table V—2, there are
approximately 53,121 CWSs and 56
States and territories considered in this
ICR (a total of 53,177 respondents).
During the first three years after
promulgation of this rule, the average
burden hours per respondent per year is
estimated to be 6 hours for PWSs and
115 hours for States. During this period,
the total burden hour per year for the
approximately 53,177 respondents
covered by this rule is estimated to be
342,873 hours to prepare to comply
with this revised Radionuclide Rule.
There are no new monitoring, record-
keeping, reporting or equipment costs
for CWSs during the first three-year
period, hence no responses are expected
from the CWSs. The average number of
responses for the States is expected to
be 37 per year during the first three year
period. Total annual labor costs during
this first 3 year period are expected to
be about $10 million per year for CWS.
TABLE v-2.—AVERAGE BURDEN, RESPONDENTS, AND RESPONSES DURING THE THREE-YEAR ICR APPROVAL PERIOD
Average Burden Hours per Respondent per Year
Average Burden Hours per Response per Year
Averaae Resoonses oer Resoondent oer Year
CWSs
336,433
53,121
6
10
10
10
States
6,440
56
115
33
17
2.66
Total
(each year)
342,873
53,177
121
33
17
.66
1 Preparation only.
2Two over 3-year period.
TABLE V-3.—SUMMARY OF BURDEN AND COSTS FOR THE RADIONUCLIDES RULE FOR THE ICR APPROVAL PERIOD
Respondent Category
CWSs
States
Total
Number of
respondents
annually
53,121
56
53,177
Number of
responses
annually
(1)
2 37 (2 per
respondent
over 3 year
period)
33
Total annual
burden
(hours)
336,433
6,440
342,873
Total annual
labor costs
($ dollars)
$9,925,042
247,905
10,172,947
Total annual
capital cost
0
0
0
Total annual
O&M cost
0
0
0
1 Preparation only.
2Twp per respondent over 3-year period.
Three years after the promulgation
date, community water systems will
begin collecting mandatory monitoring
data as described earlier in this section.
As reported in the ICR (using a 7%
discount rate over a 23 year period),
EPA estimates that today's revisions to
monitoring will result in a national
annual monitoring, reporting and record
keeping burden of $ 4.85 million
(25,197 hours) for all CWSs and an
average annual programmatic burden of
$63,723 (4,170 hours) for States (total
for all 56 jurisdictions) over the first 23
years after promulgation of this rule (see
Table V-4).
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76740 Federal Register/Vol. 65, No. 236/Thursday, December 7, 2000/Rules and Regulations
TABLE V-4.—SUMMARY OF BURDEN AND COSTS FOR THE RADIONUCLIDES RULE FOR THE POST-ICR APPROVAL PERIOD
Respondent category
CWSs
States
Toiat
Number of
respondents
annually
53,121
56
53,177
Number of
responses
annually
50,394
224
50,618
Total annual
burden
(hours)
25,197
4,170
29,367
Total annual
labor costs
$537,574
63,723
601,297
Total annual
capital cost
0
0-
0
Total annual
O&M cost
(monitoring)
$4,855,439
63,723
4,919,162
Burden means the total time, effort, or
financial resources expended by persons
to generate, maintain, retain, or disclose
or provide information to or for a
Federal agency. This includes the time
needed to review instructions; develop,
acquire, install, and utilize technology
and systems for the purposes of
collecting, validating, and verifying
information, processing and
maintaining information, and disclosing
and providing information; adjust the
existing procedures to comply with any
previously applicable instructions and
requirements; train personnel to be able
to respond to a collection of
information; search data sources;
complete and review the collection of
information; and transmit or otherwise
disclose the information.
An agency may not conduct or
sponsor, and a person is not required to
respond to, a collection of information
unless it displays a currently valid OMB
control number. The OMB control
numbers for EPA's regulations are listed
in 40 CFRpart 9 and 48 CFR chapter 15.
EPA is amending the table in 40 CFR
part 9 of the currently approved ICR
control numbers issued by OMB for
various regulations to list the
information requirements contained in
this final rule.
C. Unfunded Mandates Reform Act
1. Summary of UMRA Requirements
Title II of the Unfunded Mandates
Reform Act of 1995 (UMRA), Pub.L.
104-4, establishes requirements for
Federal agencies to assess the effects of
their regulatory actions on State, local,
and tribal governments and the private
sector. Under UMRA section 202, EPA
generally must prepare a written
statement, including a cost-benefit
analysis, for proposed and final rules
with "Federal mandates" that may
result in expenditures to State, local,
and tribal governments, in the aggregate,
or to the private sector, of S100 million
or more in any one year. Before
promulgating an EPA rule, for which a
written statement is needed, section 205
of the UMRA generally requires EPA to
identify and consider a reasonable
number of regulatory alternatives and
adopt the least costly, most cost-
effective or least burdensome alternative
that achieves the objectives of the rule.
The provisions of section 205 do not
apply when they are inconsistent with
applicable law. Moreover, section 205
allows EPA to adopt an alternative other
than the least costly, most cost-effective
or least burdensome alternative if the
Administrator publishes with the final
rule an explanation of why that
alternative was not adopted.
Before EPA establishes any regulatory
requirements that may significantly or
uniquely affect small governments,
including tribal governments, it must
have developed, under section 203 of
the UMRA, a small government agency
plan. The plan must provide for
notifying potentially affected small
governments, enabling officials of
affected small governments to have
meaningful and timely input in the
development of EPA regulatory
proposals with significant Federal
intergovernmental mandates and
informing, educating, and advising
small governments on compliance with
the regulatory requirements.
EPA has determined that this rule
does not contain a Federal mandate that
may result in expenditures of $100
million or more for State, local, and
tribal governments, in the aggregate, or
the private sector in any one year. The
estimated total annual compliance costs
of the final rule is 83 million (See
section IV. Economic Analyses for
additional information). Thus, today's
rule is not subject to the requirements
of sections 202 and 205 of the UMRA.
This rule will establish requirements
that affect small community water
systems. EPA has determined that this
rule may contain regulatory
requirements that significantly or
uniquely affect small governments. As
described in part A of this section, EPA
has provided all public water systems
(including small systems) with
opportunities to provide input into the
development of this rule and to be
informed about the requirements for
compliance.
D. National Technology Transfer and
Advancement Act
Section 12(d) of the National
Technology Transfer and Advancement
Act of 1995 (NTTAA), (Pub. L. 104-113,
section 12(d), 15 U.S.C. 272 note),
directs EPA to use voluntary consensus
standards in its regulatory activities
unless to do so would be inconsistent
with applicable law or otherwise
impractical. Voluntary consensus
standards are technical standards (e.g.,
material specifications, test methods,
sampling procedures, business
practices) that are developed or adopted
by voluntary consensus standard bodies.
The NTTAA directs EPA to provide to
Congress, through OMB, explanations
when the Agency decides not to use
available and applicable voluntary
consensus standards.
Today's rule does not establish any
technical standards, thus, NTTAA does
not apply to this rule. It should be
noted, however, that systems complying
with this rule need to use previously
approved technical standards already
included in § 141.25. Currently, a total
of 89 radiochemical methods are
7 approved for compliance monitoring of
radionuclides in drinking water. Of
these methods, twenty-four (24) are
approved by the Standard Methods
Committee and are described in the
"Standard Methods for the Examination
of Waste and Wastewater (13th, 17th,
18th, and 19th editions)," which was
prepared and published by the
American Public Health Association. In
addition, twelve of the approved
radiochemistry methods are from the
American Society for Testing and
Materials (ASTM) and are described in
the Annual Book of ASTM Standards.
These methods and their references are
provided in Table 1-8 (shown in section
I of this preamble).
E. Executive Order 12866: Regulatory
Planning and Review
Under Executive Order 12866, [58 FR
51735 (October 4,1993)] the Agency
must determine whether the regulatory
action is "significant" and therefore
subject to OMB review and the
requirements of the Executive Order.
The Order defines "significant
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Federal Register/Vol. 65, No. 236/Thursday, December 7, 2000/Rules and Regulations 76741
regulatory action" as one that is likely
to result in a rule that may:
(1) Have an annual effect on the
economy of $100 million or more or
adversely affect in a material way the
economy, a sector of the economy,
productivity, competition, jobs, the
environment, public health or safety, or
State, local, or tribal governments or
communities;
(2) Create a serious inconsistency or
otherwise interfere with an action taken
or planned by another agency;
(3) Materially alter the budgetary
impact of entitlements, grants, user fees,
or loan programs or the rights and
obligations of recipients thereof; or
(4) Raise novel legal or policy issues
arising out of legal mandates, the
President's priorities, or the principles
set forth in the Executive Order."
Pursuant to the terms of Executive
Order 12866, it has been determined
that this rule is a "significant regulatory
action." As such, this action was
submitted to OMB for review. Changes
made in response to OMB suggestions or
recommendations will be documented
in the public record.
F. Executive Order 12898:
Environmental Justice
Executive Order 12898 "Federal
Actions To Address Environmental
Justice in Minority Populations and
Low-Income Populations," (59 FR 7629,
February 16,1994) establishes a Federal
policy for incorporating environmental
justice into Federal agency missions by
directing agencies to identify and
address disproportionately high and
adverse human health or environmental
effects of its. programs, policies, and
activities on minority and low-income
populations. The Agency has
considered environmental justice-
related issues concerning the potential
impacts of this action and has consulted
with minority and low-income
stakeholders by convening a stakeholder
meeting via video conference
specifically to address environmental
justice issues.
As part of EPA's responsibilities to
comply with E.O. 12898, the Agency
held a stakeholder meeting via video
conference on March 12,1998, to
highlight components of pending
drinking water regulations and how
they may Impact sensitive sub-
populations, minority populations, and
low-income populations. Topics
discussed included treatment
techniques, costs and benefits, data
quality, health effects, and the
regulatory process. Participants
included national, State, tribal,
municipal, and individual stakeholders.
EPA conducted the meeting by video
conference call between eleven cities.
This meeting was a continuation of
stakeholder meetings that started in
1995 to obtain input on the Agency's
Drinking Water programs. The major
objectives for the 1998 meeting were:
(1) Solicit ideas from Environmental
Justice (EJ) stakeholders on known
issues concerning current drinking
water regulatory efforts;
(2) Identify key issues of concern to EJ
stakeholders; and
(3) Receive suggestions from EJ
stakeholders concerning ways to
increase representation of EJ
communities in OGWDW regulatory
efforts.
In addition, EPA developed a plain-
English guide specifically for this
meeting to assist stakeholders in
understanding the multiple and
sometimes complex issues surrounding
drinking water regulations. A meeting
summary for the March 12,1998
Environmental Justice stakeholders
meeting (USEPA 1998J) is available in
the public docket for this final
rulemaking.
The radionuclides rule applies to all
community water systems, which will
provide equal health protection for all
minority and low-income populations
served by systems regulated under this
rule from exposure to radionuclides.
G. Executive Order 13045: Protection of
Children From Environmental Health
Bisks and Safety Risks
Executive Order 13045: "Protection of
Children from Environmental Health
Risks and Safety Risks" (62 FR 19885,
April 23,1997) applies to any rule that:
(1) Was initiated after April 21,1997, or
for which a Notice of Proposed
Rulemaking was published after April
21,1998; (2) is determined to be
"economically significant" as defined
under E.O. 12866, and (3) concerns an
environmental health or safety risk that
EPA has reason to believe may have a
disproportionate effect on children. If
the regulatory action meets all three
criteria, the Agency must evaluate the
environmental health or safety effects of
the planned rule on children, and
explain why the planned regulation is
preferable to other potentially effective
and reasonably feasible alternatives
considered by the Agency.
This final rule is not subject to the
Executive Order because EPA published
a notice of proposed rulemaking before
April 21,1998. However, EPA's policy
since November 1,1995 is to
consistently and explicitly consider
risks to infants and children in all risk
assessments generated during its
decision making process including the
setting of standards to protect public
health and the environment.
Today's action primarily involves
retaining the current MCLs for the
regulated radionuclides, rather than
adopting the less stringent 1991
proposed MCLs for the regulated
radionuclides. In addition, an MCL for
uranium, currently unregulated, is
promulgated in today's rule. Since
today's rule involves the decision to
retain the more stringent current MCLs
and to adopt a uranium MCL that is
protective of both kidney toxicity and
radiological carcinogenicity, today's
action is consistent with greater
protection of children's health.
The cancer risks estimated and
presented in today's final rule explicitly
account for differential cancer risks to
children. In the case of uranium kidney
toxicity, there is no information that
suggests that children are a sensitive
subpopulation. However, as discussed
in the Notice of Data Availability
(USEPA 2000e), the Agency does have
reason to believe that radionuclides in
drinking water present higher unit risks
to children than to adults, since there is
evidence that children are more
sensitive to radiation than adults.
Because of this, we have explicitly
considered the risks to children in
evaluating the lifetime risks associated
with the current MCLs and 1991
proposed MCLs. In other words, the
lifetime risks that are reported for each
MCL are integrated over the entire
lifetime of the individual and include
the risks incurred during childhood.
In more detail, the per unit dose risk
coefficients used to estimate lifetime
risks are age-specific and organ-specific
and are used in a lifetime risk model
that applies the appropriate age-specific
sensitivities throughout the calculation.
The model also includes age-specific
changes in organ mass and metabolism,
which further incorporates age-specific
effects pertinent to age sensitivity. The
risk estimate at any age is the best
estimate of risk for an individual of that
age, so the summation of these age-
specific risk estimates over all ages is
best estimate of the lifetime risk for an
individual. In developing the lifetime
risks, the model calculates the risks over
an age distribution for a stationary
population to simulate the lifetime risk
of an individual. The model also
accounts for competing causes of death
and age-specific survival rates. These
adjustments make the lifetime risk
estimate more realistic. At the same
time, consumption rates of food, water
and ,air are different between adults and
children. The lifetime risk estimates for
radionuclides in water use age-specific
water intake rates derived from average
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76742 Federal Register/Vol. 65, No. 236/Thursday, December 7, 2000/Rules and Regulations
national consumption rates when
calculating the risk per unit intake.
While radiation protection
organizations have developed the
concept of committed dose, the dose to
an organ or tissue from time of intake
to end of life, there is no equivalent for
risk. If we define "committed risk" as
the lifetime risk from a given intake,
then it will be easier to compare the
risks of intakes at different times of life.
In Table V-5, the "committed risk" is
given for 5 isotopes and 5 periods of life
and continuous lifetime exposure. If the
radionuclide concentration in the water
is kept constant, the fraction of the
lifetime risk committed during any age
interval will also remain constant.
Unless the intake is restricted in an age-
specific manner, the fraction of the
lifetime risk contributed by any age
interval is a constant.
TABLE V-5.—LIFETIME RISKS AND FRACTIONS OF LIFETIME RISK PER AGE GROUP
Age (yts)
0-6
6-18
18-30
30-70
70-110
0-110
Lifetime risk for intake of water containing 1 Bq/L during several different age intervals
Ra-224 . •
Ra-226 . . .
Ra-228
U-238
H-3
2.3e-05
2.9e-05
1.1e-04
6.76-06
3.9e-09
3.3e-05
8.6e-05
2.66-04
1.26-05
8.56-09
1.16-05
S.Oe-05
1.26-04
6.16-06.
6.26-09
1.56-05
5.16-05
1.16-04
. 9.86-06
9.66-09
9.86-07
2.96-06
5.1e-06
3.7e-07
6.7e-10
8.46-05
2.2e-04
6.16-04
3.46-05
2.9e-08
Percentage of lifetime risk committed for water intake during the age interval
Ra-224
Ra-226
Ra-228 . ...
U-238
H-3 .
28
13
17
19
13
40
39
43
33
29
13
23
20
18
21
18
23
19
28
33
1
1
1
1
2
100
100
100
100
100
In summary, today's decision to retain
the current more stringent MCLs for
radionuclides and to establish an MCL
for uranium in drinking water is
consistent with the protection of
children's health. In making this
decision, EPA evaluated the lifetime
radiogenic cancer risks associated with
the current and final MCLs, which are
based on age-specific cancer risk models
that explicitly consider children's
higher per unit dose risks.
H, Executive Order 13084: Consultation
and Coordination With Indian Tribal
Governments
Under Executive Order 13084, EPA
may not issue a regulation that is not
required by statute if it significantly or
uniquely affects the communities of
Indian tribal governments and imposes
substantial direct compliance costs on
those communities, unless the Federal
government provides the funds
necessary to pay the direct compliance
costs incurred by the tribal governments
or if EPA consults with those
governments. If EPA complies by
consulting. Executive Order 13084
requires EPA to provide to the Office of
Management and Budget, in a separately
identified section of the preamble to the
rule, a description of the extent of EPA's
prior consultation with representatives
of affected tribal governments, a
summary of the nature of their concerns,
and a statement supporting the need to
issue the regulation. In addition,
Executive Order 13084 requires EPA to
develop an effective process permitting
elected officials and other
representatives of Indian tribal
governments "to provide meaningful
and timely input in the development of
regulatory policies on matters that
significantly or uniquely affect their
communities."
EPA does not believe that today's rule
significantly or uniquely affect the
communities of Indian tribal
governments nor does it impose
substantial direct compliance costs on
these communities. The provisions of
today's rules apply to all community
water systems. Tribal governments may
be owners or operators of such systems,
however, nothing in today's provisions
uniquely affects them. EPA believes that
the final rule will not significantly
burdens most Tribal systems, and in
some cases, will be less burdensome
than the current radionuclides rule.
Accordingly, the requirements of
section 3(b) of Executive Order 13084
do not apply to this rule.
Nonetheless, EPA did inform and
involve Tribal governments in the
rulemaking process. EPA staff attended
the 16th Annual Consumer Conference
of the National Indian Health Board on
October 6-8,1998 in Anchorage,
Alaska. Over nine hundred attendees
representing Tribes from across the
country were in attendance. During the
conference, EPA conducted two
workshops for meeting participants. The
objectives of the workshops were to
present an overview of EPA's drinking
water program, solicit comments on key
issues of potential interest in upcoming
drinking water regulations, and to
solicit advice in identifying an effective
consultative process with Tribes for the
future.
EPA, in conjunction with the Inter
Tribal Council of Arizona (ITCA), also
convened a Tribal consultation meeting
on February 24-25,1999, in Las Vegas,
Nevada to discuss ways to involve
Tribal representatives, both Tribal
council members and tribal water utility
operators, in the stakeholder process.
Approximately twenty-five
representatives from a diverse group of
Tribes attended the two-day meeting.
Meeting participants included
representatives from the following
Tribes: Cherokee Nation, Nezperce
Tribe, Jicarilla Apache Tribe, Blackfeet
Tribe, Seminole Tribe of Florida, Hopi
Tribe, Cheyenne River Sioux Tribe,
Menominee Indian Tribe, Tulalip
Tribes, Mississippi Band of Choctaw
Indians, Narragansett Indian Tribe, and
Yakama Nation.
The major meeting objectives were to:
(1) Identify key issues of concern to
Tribal representatives;
(2) Solicit input on issues concerning
current OGWDW regulatory efforts;
(3) Solicit input and information that
should be included in support of future
drinking water regulations; and
(4) Provide an effective format for
Tribal involvement in EPA's regulatory
development process.
EPA staff also provided an overview
on the forthcoming radionuclides rule at
the meeting. The presentation included
the health concerns associated with
radionuclides, EPA's current position
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Federal Register/Vol. 65, No. 236/Thursday, December 7, 2000/Rules and Regulations 76743
on radionuclides in drinking water, and
specific issues for Tribes. The following
questions were posed to the Tribal
representatives to begin discussion on
radionuclides in drinking water:
(1) What are the current radionuclides
levels in your water systems?
(2) Are you treating for radionuclides
if they exceed the MCL? Is it effective
and affordable?
(3) What are Tribal water systems
affordability issues in regard to
radionuclides?
(4) Would in home treatment units be
an acceptable alternative to central
treatment?
(5) What level of monitoring is
reasonable?
The summary for the February 24-25,
1999 meeting was sent to all 565
Federally recognized Tribes in the
United States. '. .
EPA also conducted a series of
workshops at the Annual Conference of
the National Tribal Environmental -
Council which was held on May 18—20,
1999 in Eureka, California.
Representatives from over 50 Tribes
attended all, or part, of these sessions.
The objectives of the workshops were to
provide an overview of forthcoming
EPA regulations affecting water systems;
discuss changes to operator certification
requirements; discuss funding for Tribal
•water systems; and to discuss
innovative approaches to regulatory cost
reduction. Meeting summaries forEPA's
Tribal consultations are available in the
public docket for this rulemaking
(USEPA 1999C, USEPA 1999d).
I. Executive Order 13132
Executive Order 13132, entitled
"Federalism" (64 FR 43255, August 10,
1999), requires EPA to develop an
accountable process to ensure
"meaningful and timely input by State
and local officials in the development of
regulatory policies that have federalism
implications." "Policies that have
federalism implicatipns'are defined in
the Executive Order to include
regulations that have "substantial direct
effects on the States, on the relationship
between the national government and
the States, or on the distribution of
power and responsibilities among the
various levels of government."
This final rule does not have
federalism implications. It will not have
substantial direct effects on the States,
on the relationship between the national
government and the States, or on the
distribution of power and
responsibilities among the various
levels of government, as specified in
Executive Order 13132.Thus, Executive
Order 13132 does not apply to this rule
Although Executive Order 13132 does
not apply to this rule, EPA did consult
with representatives of State and local
elected officials in the process of
developing this final regulation. On May
30, 2000, EPA held a one-day meeting
in Washington, DC with representatives
of elected State and local officials to
discuss how upcoming drinking water
regulations may affect State, county, and
local governments. The rules discussed
were: Arsenic, Radon, Radionuclides,
Long Term 1 Enhanced Surface Water
Treatment and Filter Backwash Rule,
and the Ground Water Rule. EPA
invited associations which represent
elected officials, including National
Governors' Association (NGA), National
League of Cities (NLC), Council of State
Governments (CSG), U.S. Conference of
Mayors, International City/County
Management Association, (ICMA),
National Association of Counties
(NACO), National Association of Towns
and Townships, and National
Conference of State Legislators (NCSL).
EPA also invited the National . ;
Association of Attorneys General
(NAAG), the Association of State and
Territorial Health Officials (ASTHO),
the Environmental Council of States -
(EGOS), and the Southern Govenors'
Association (SGO). With the invitation
letter, EPA provided an agenda and
background information about the five
upcoming drinking water rules,
including today's rule.
Ten representatives of elected officials
participated in the one-day meeting,
which included State of Florida—
Governor Bush's Office, State of Ohio-
Governor Taft's Office, NGA, NACO,
NAAG, NLC, EGOS, ICMA, SGO, and
ASTHO. The meeting encompassed
presentation and discussion about each
of the five rules. The purpose of the
meeting was to:
• Provide information about the five,
upcoming drinking water regulations;
• Consult on the expected
compliance and implementation costs of
these rules for State, county, and local
governments; and
• Gain a better understanding of
State, county, and local governments'
and their elected officials' views.
Following the meeting, EPA sent the
materials presented and distributed at
the meeting to the organizations that
were not able to attend, in order to
provide them additional information
about the upcoming regulations. EPA
has prepared a meeting summary which
provides in more detail the participants'
concerns and questions regarding each
rule. This summary is available in the
public docket supporting this
rulemaking (USEPA 2000c).
This meeting was not held sooner due
to the relatively recently signed
Executive Order and the need to
consider how to best comply with its
terms and conditions. Thus, many of the
issues associated with today's
rulemaking were in relatively advanced
stages of development by the time of the
May 30, 2000 meeting. Nevertheless, we
endeavored to accommodate each of the
comments received from elected
officials or their representatives to the
maximum extent possible, within the
constraints imposed by our statutory
mandate to protect public health
through the promulgation of drinking
water standards.
The principal concerns of these
officials were the' overall burden of the
rule and the potentially high costs of
compliance with its provisions, hi
particular, they expressed concerns
about the affordability for the rule for
small systems and costs for disposal of
treatment residues that may be
considered hazardous due to
radioactivity. In response, we took
several steps to address these particular
concerns as well as actions in response
to the generalized concern about the
overall burden of the rule.
EPA believes that today's regulatory
action is necessary to reduce kidney •
toxicity and cancer health risks from
uranium, as well as to maintain public
health protection resulting from the
current radionuclide National Primary
Drinking Water Regulations. The
Agency understands the officials'
concerns about regulatory burden and
have addressed them in several ways.
First, EPA selected a less stringent MCL
for uranium of 30 |j.g/L by invoking the
discretionary authority for the
Administrator to set an MCL less
stringent than the feasible level if the
benefits of an MCL set at the feasible
level would not justify the costs (section
1412(b)(6)). As a result, fewer water
systems will be in violation of the
uranium MCL, reducing the number of
systems that may face radioactive waste
disposal issues, and resulting in the
ability of a higher percentage of water
systems to use non-treatment options for
achieving compliance (e.g., new wells,
blending of water sources, modifying
existing operations, etc.).
To further mitigate impacts on water
systems and State drinking water
programs, EPA is allowing State
discretion in grandfathering data for
determining initial monitoring
frequency. Since the data grandfathering
plan will be a part of a State's primacy
package, EPA will have oversight over
the data grandfathering process. EPA
believes that this approach provides
flexibility for States to consider their
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76744 Federal Register/Vol. 65, No. 236/Thursday, December 7, 2000/Rules and Regulations
particular circumstances, while
allowing EPA to ensure that goals are
met. Under this approach, many
systems will be able to use existing
monitoring data to establish initial
monitoring baselines, which will be
used to determine future monitoring
frequency under the Standardized
Monitoring Framework. Water systems
that do not have adequate data to
grandfather will be required to follow
the requirements for new monitoring.
The details of these requirements can be
found in part J of section I, "Where and
how often must a water system test for
radionuclides?" EPA expects that there
xvill be overall reduced monitoring
burden in the long-term, with
monitoring relief being targeted towards
those water systems that have low
radionuclide levels. Today's final rule
will not apply to non-transient, non-
community water systems (e.g., schools,
state parks, nursing homes), which are
primarily small ground water systems.
EPA -will provide guidance to small
water systems on complying with
today's rule. This will include
information on monitoring, treatment
technology and other compliance
options, including information on the
disposal of water treatment residuals.
Regarding the cost of treatment, EPA
agrees that treatment technologies can
be expensive for small water systems.
However, EPA expects that many small
water systems will rely on other
compliance options, e.g., alternate
source, purchasing water, and point-of-
use devices. In cases in which small
water systems have no other option and
cannot afford to install treatment, they
may apply to the State for exemptions
(see part M of section I, "Can my water
system get a variance or an
exemption?"), which gives them extra
time. An exemption is limited to three
years after the otherwise applicable
compliance date, although extensions
up to a total of six additional years may
be available to small systems under
certain conditions. If a water system has
very high contaminant levels and no
compliance options other than
treatment, the water system can apply
for a variance, under the requirements
described in part M of section I. In
addition, there are various sources of
funding for State and local governments,
including the Drinking Water State
Revolving Fund, which is described in
part M of section I, "What financial
assistance is available for complying
with the rule?"
/. Consultation With the Science
Advisory Board and the National
Drinking Water Advisory Council
In accordance with section 1412(d)
and (e) of SDWA, EPA consulted with
the Science Advisory Board and
National Drinking Water Advisory
Council and considered their comments.
in developing this rule. See the OW
Docket for additional information.
K. Congressional Review Act
The Congressional Review Act, 5
U.S.C. 801 etseq., as added by the Small
Business Regulatory Enforcement
Fairness Act of 1996, generally provides
that before a rule may take effect, the
agency promulgating the rule must
submit a rule report, which includes a
copy of the rule, to each House of the
Congress and to the Comptroller General
of the United States. EPA will submit a
report containing this rale and other
required information to the U.S. Senate,
the U.S. House of Representatives, and
the Comptroller General of the United
States prior to publication of the rule in
the Federal Register. A major rule
cannot take effect until 60 days after it
is published in the Federal Register.
This rule is not a "major rule" as
defined by 5 U.S.C. 804(2). This rule
will be effective December 8, 2003.
VI. References
NIH 2000a. "Kidney Diseases: Publications
On-Line." National Institute of Diabetes
and Digestive and Kidney Diseases
(NIDDK). June 2000. National Institutes of
Health.
NIH 2000b. "Proteinuria." National Kidney
and Urologic Diseases Information
Clearinghouse. June 2000. National
Institutes of Health.
NIH 2000c. "Your Kidneys and How They
Work." National Kidney and Urologic
Diseases Information Clearinghouse. June
2000. National Institutes of Health.
USEPA 1991. "Regulatory Impact Analysis of
Proposed National Primary Drinking Water
Regulations for Radionuclides [Draft dated
June 14,1991). Prepared by Wade Miller
Associates.
USEPA 1994. Federal Actions to Address
Environmental Justice in Minority
Populations and Low-Income Populations,
59 FR 7629, February 16,1994.
USEPA 1998a. "A Fact Sheet on the Health
Effects from Ionizing Radiation." Prepared
by the Office of Radiation & Indoor Air,
Radiation Protection Division. EPA 402-F-
98-010. May 1998.
USEPA 1998b. Announcement of Small
System Compliance Technology Lists for
Existing National Primary Drinking Water
Regulations and Findings Concerning
Variance Technologies, 63 FR 42032,
August 6,1998.
USEPA 1998c. "Ionizing Radiation Series No.
1." Prepared by the Office of Radiation &
Indoor Air, Radiation Protection Division.
EPA 402-F-98-009. May 1998.
-USEPA 1998d. National Primary Drinking
Water Regulations: Consumer Confidence;
Proposed Rule 63 FR 7605, February 13,
1998.
USEPA 1998e. National Primary Drinking
Water Regulation: Consumer Confidence
Reports; Final Rule, 63 FR 44511, August
19,1998.
USEPA 1998f. "Small System Compliance
Technology List for the Non-Microbial
Contaminants Regulated Before 1996."
EPA-815-R-98-002. September 1998.
USEPA 1999a. "Small Systems Compliance
Technology List for the Radionuclides
Rule." Prepared by International
Consultants, Inc. Draft. April 1999.
USEPA 1999b. Cancer Risk Coefficients for
Environmental Exposure to Radionuclides,
Federal Guidance Report No. 13. US
Environmental Protection Agency,
Washington, DC, 1999.
USEPA 1999c. "Inter Tribal Council of
Arizona, Inc.: Ground Water and Drinking
Water Tribal Consultation Meeting."
Executive Summary. February 24-25,1999.
USEPA 1999d. "OGWDW Tribal
Consultations: Workshops at the Annual
Conference of the National Tribal
Environmental Council." May 18—20, 1999.
USEPA 2000a. "Comment/Response
Document for the Radionuclides Notice of
Data Availability and 1991 Proposed
Rule." Prepared by Industrial Economics,
Inc. for EPA. November 2000.
USEPA 2000b. "Draft Toxicological Review
of Uranium." Prepared by the Office of
Science and Technology. Draft. June 6,
2000. '
USEPA 2000c. Government Dialogue on U.S.
EPA's Upcoming Drinking Water
Regulations. Meeting Summary. May 30,
2000.
USEPA 2000d. "Information Collection
Request for National Primary Drinking
Water Regulations: Radionuclides".
Prepared by ISSI Consulting Group, for
EPA. September 22, 2000.
USEPA 2000e. National Primary Drinking
Water Regulations; Radionuclides; Notice
of Data Availability; Proposed Rule. 65 FR
21577. April 21, 2000.
USEPA 2000f. "Preliminary Health Risk
Reduction and Cost Analysis: Revised
National Primary Drinking Water
Standards for Radionuclides." Prepared by
Industrial Economics, Inc. for EPA. Draft.
January 2000.
USEPA 2000g. "Economic Analysis of the
Radionuclides National Primary Drinking
Water Regulations." Prepared by Industrial
Economics, Inc. for EPA. November 2000.
USEPA 2000h. "Technical Support
Document for the Radionuclides Notice of
Data Availability." Draft. March, 2000.
USEPA 2000i. "Technologies and Costs for
the Removal of Radionuclides from Potable
Water Supplies." Draft. Prepared by
Malcolm Pirnie, Inc. June, 2000.
List of Subjects
40 CFR Part 9
Reporting and recordkeeping
requirements.
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Federal Register/Vol. 65, No. 236/Thursday, December 7, 2000/Rules and Regulations 76745
40 CFR Part 141
Environmental protection, Chemicals,
Indians-lands, Incorporation by
reference, Intergovernmental relations,
Radiation protection, Reporting and
recordkeeping requirements, Water
supply.
40 CFR Part 142
Environmental protection,
Administrative practice and procedure,
Chemicals, Indians-lands,
Intergovernmental relations, Radiation
protection, Reporting and recordkeeping
requireme'nts, Water supply.
Dated: November 21, 2000.
Carol M. Browner,
Administrator,
For reasons set out in the preamble,
40 CFR parts 9,141, and 142 are
amended as follows:
1. The authority citation for part 9
continues to read as follows:
Authority: 7 U.S.C. 135 et seq., 136-136y;
15 U.S.C. 2001, 2003, 2005, 2006, 2601-2671;
21 U.S.C. 331), 346a, 348; 31 U.S.C. 9701; 33
U.S.C. 1251 et seq., 1311,1313d, 1314,1318,
1321,1326-1330,1324,1344,1345 (d) and
(e), 1361; E.0.11735, 38 FR 21243, 3 CFR,
1971-1975 Comp. p. 973; 42 U.S.C. 241,
242b, 243, 246, 300f, 300g, 300g-l, SOOg-^2,
300g-3, 300g-4, 300g-5, 300g-6, 300J-1,
300J-2, 300J-3, 300)^1, 300J-9,1857 et seq.,
6901-6992k, 7401-7671q, 7542, 9601-9657,
11023,11048.
2. In § 9.1 the table is amended by:
(a) Removing the entry for 141.25-
141.30 and adding new entries for
141.25(a)-(e), 141.26 (a)-(b), and
141.27-141.30;
(b) Removing the entry for 142.14(a)-
(d)(7) and adding new entries for
142.14(a)-(d)(3), 142.14(d)(4)-(5), and
142.14(d)(6)-(7); and
(c) Removing the entry for
142.15(c)(5)-(d) and adding new entries
for 142.15(c)(5), 142.15(c)(6)-(7), and
142.15(d).
The additions read as follows:
§9.1 OMB approvals under the Paperwork
Reduction Act.
40 CFR citation
OMB
control No.
National Primary Drinking
Water Regulations
141.25(a)-(e) ••
141.26(a)-
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76746 Federal Register/Vol. 65, No. 236/Thursday, December 7, 2000/Rules and Regulations
must begin to conduct initial monitoring
for the new source within the first
quarter after initiating use of the source.
CVVSs must conduct more frequent
monitoring when ordered by the State in
the event of possible contamination or
when changes in the distribution system
or treatment processes occur which may
increase the concentration of
radioactivity in finished water.
(2) Initial monitoring: Systems must
conduct initial monitoring for gross
alpha particle activity, radium-226,
radium-228, and uranium as follows:
(i) Systems without acceptable
historical data, as defined below, must
collect four consecutive quarterly
samples at all sampling points before
December 31,2007.
(ii) Grandfathering of data: States may
allow historical monitoring data
collected at a sampling point to satisfy
the initial monitoring requirements for
that sampling point, for the following
situations.
(A) To satisfy initial monitoring
requirements, a community water
system having only one entry point to
the distribution system may use the
monitoring data from the last
compliance monitoring period that
began between June 2000 and December
8,2003.
(B) To satisfy initial monitoring
requirements, a community water
system with multiple entry points and
having appropriate historical
monitoring data for each entry point to
the distribution system may use the
monitoring data from the last
compliance monitoring period that
began between June 2000 and December
8,2003.
(C) To satisfy initial monitoring
requirements, a community water
system with appropriate historical data
for a representative point in the
distribution system may use the
monitoring data from the last
compliance monitoring period that
began between June 2000 and December
8,'2003, provided that the State finds
that the historical data satisfactorily
demonstrate that each entry point to the
distribution system is expected to be in
compliance based upon the historical
data and reasonable assumptions about
the variability of contaminant levels
between entry points. The State must
make a written finding indicating how
the data conforms to the these
requirements.
(iii) For gross alpha particle activity,
uranium, radium-226, and radium-228
monitoring, the State may waive the
final two quarters of initial monitoring
for a sampling point if the results of the
samples from the previous two quarters
are below the detection limit.
(iv) If the average of the initial
monitoring results for a sampling point
is above the MCL, the system must
collect and analyze quarterly samples at
that sampling point until the system has
results from four consecutive quarters
that are at or below the MCL, unless the
system enters into another schedule as
part of a formal compliance agreement
with the State.
(3) Reduced monitoring: States may
allow community water systems to
reduce the future frequency of
monitoring from once every three years
to once every six or nine years at each
sampling point, based on the following
criteria.
(i) If the average of the initial
monitoring results for each contaminant
(i.e., gross alpha particle activity,
uranium, radium-226, or radium-228) is
below the detection limit specified in
Table B, in § 141.25(c)(l), the system
must collect and analyze for that
contaminant using at least one sample at
that sampling point every nine years.
(ii) For gross alpha particle activity
and uranium, if the average of the initial
monitoring results for each contaminant
is at or above the detection limit but at
or below Vz the MCL, the system must
collect and analyze for that contaminant
using at least one sample at that
sampling point every six years. For
combined radium-226 and radium-228,
the analytical results must be combined.
If the average of the combined initial
monitoring results for radium-226 and
radium-228 is at or above the detection
limit but at or below Vz the MCL, the
system must collect and analyze for that
contaminant using at least one sample at
that sampling point every six years.
(iii) For gross alpha particle activity
and uranium, if the average of the initial
monitoring results for each contaminant
is above Vz the MCL but at or below the
MCL, the system must collect and
analyze at least one sample at that
sampling point every three years. For
combined radium-226 and radium-228,
the analytical results must be combined.
If the average of the combined initial
monitoring results for radium-226 and
radium-228 is above Vz the MCL but at
or below the MCL, the system must
collect and analyze at least one sample
at that sampling point every three years.
(iv) Systems must use the samples
collected during the reduced monitoring
period to determine the monitoring
frequency for subsequent monitoring
periods (e.g., if a system's sampling
point is on a nine year monitoring
period, and the sample result is above
Vz MCL, then the next monitoring
period for that sampling point is three
years).
(v) If a system has a monitoring result
that exceeds the MCL while on reduced
monitoring, the system must collect and
analyze quarterly samples at that
sampling point until the system has
results from four consecutive quarters
that are below the MCL, unless the
system enters into another schedule as
part of a formal compliance agreement
with the State.
(4) Compositing: To fulfill quarterly
monitoring requirements for gross alpha
particle activity, radium-226, radium-
228, or uranium, a system may
composite up to four consecutive
quarterly samples from a single entry
point if analysis is done within a year
of the first sample. States will treat
analytical results from the composited
as the average analytical result to
determine compliance with the MCLs
and the future monitoring frequency. If
the analytical result from the
composited sample is greater than Vz
MCL, the State may direct the system to
take additional quarterly samples before
allowing the system to sample under a
reduced monitoring schedule.
(5) A gross alpha particle activity
measurement may be substituted for the
required radium-226 measurement
provided that the measured gross alpha
particle activity does not exceed 5
pCi/1. A gross alpha particle activity
measurement may be substituted for the
required uranium measurement
provided that the measured gross alpha
particle activity does not exceed 15
pCi/1.
The gross alpha measurement shall
have a confidence interval of 95%
(1.65cr, where cr is the standard
deviation of the net counting rate of the
sample) for radium-226 and uranium.
When a system uses a gross alpha
particle activity measurement in lieu of
a radium-226 and/or uranium
measurement, the gross alpha particle
activity analytical result will be used to
determine the future monitoring
frequency for radium-226 and/or
uranium. If the gross alpha particle
activity result is less than detection, Vz
the detection limit will be used to
determine compliance and the future
monitoring frequency.
(b) Monitoring and compliance.
requirements for beta particle and
photon radioactivity.
To determine compliance with the
maximum contaminant levels in
§ 141.66(d) for beta particle and photon
radioactivity, a system must monitor at
a frequency as follows:
(l) Community water systems (both
surface and ground water) designated by
the State as vulnerable must sample for
beta particle and photon radioactivity.
Systems must collect quarterly samples
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Federal Register/Vol. 65, No. 236/Thursday, December 7, 2000/Rules and Regulations 76747
for beta emitters and annual samples for
tritium and strontium-90 at each entry
point to the distribution system
(hereafter called a sampling point),
beginning within one quarter after being
notified by the State. Systems already
designated by the State must continue to
sample until the State reviews and
either reaffirms or removes the
designation.
(i) If the gross beta particle activity
minus the naturally occurring
potassium-40 beta particle activity at a
sampling point has a running annual
average (computed quarterly) less than
or equal to 50 pCi/L (screening level),
the State may reduce the frequency of
monitoring at that sampling point to
once every 3 years. Systems must collect
all samples required in paragraph (b)(l)
of this section during the reduced
monitoring period.
(ii) For systems in the vicinity of a
nuclear facility, the State may allow the
CWS to utilize environmental
surveillance data collected by the
nuclear facility in lieu of monitoring at
the system's entry point(s), where the
State determines if such data is
applicable to a particular water system.
In the event that there is a release from
a nuclear facility, systems which are
using surveillance data must begin
monitoring at the community water
system's entry point(s) in accordance
with paragraph (b)(l) of this section.
(2) Community water systems (both
surface and ground water) designated by
the State as utilizing waters
contaminated by effluents from nuclear
facilities must sample for beta particle
and photon radioactivity. Systems must
collect quarterly samples for beta
emitters and iodine-131 and annual
samples for tritium and strontium-90 at
each entry point to the distribution
system (hereafter called a sampling
point), beginning within one quarter
after being notified by the State.
Systems already designated by the State
as systems using waters contaminated
by effluents from nuclear facilities must
continue to sample until the State
reviews and either reaffirms or removes
the designation.
(i) Quarterly monitoring for gross beta
particle activity shall be based on the
analysis of monthly samples or the
analysis of a composite of three monthly
samples. The former is recommended.
(ii) For iodine-131, a composite of five
consecutive daily samples shall be
analyzed once each quarter. As ordered
by the State, more frequent monitoring
shall be conducted when iodine-131 is
identified in the finished water.
(iii) Annual monitoring for strontium-
90 and tritium shall be conducted by
means of the analysis of a composite of
four consecutive quarterly samples or
analysis of four quarterly samples. The
latter procedure is recommended.
(iv) If the gross beta particle activity
beta minus the naturally occurring
potassium-40 beta particle activity at a
sampling point has a running annual
average (computed quarterly) less than
or equal to 15 pCi/L, the State may
reduce the frequency of monitoring at
that sampling point to every 3 years.
Systems must collect all samples
required in paragraph (b)(2) of this
section during the reduced monitoring
period.
(v) For systems in the vicinity of a
nuclear facility, the State may allow the
CWS to utilize environmental
surveillance data collected by the
nuclear facility in lieu of monitoring at
the system's entry point(s), -where the
State determines if such data is
applicable to a particular water system.
In the event that there is a release from
a nuclear facility, systems which are
using surveillance data must begin
monitoring at the community water
system's entry point(s) in accordance
with paragraph (b)(2) of this section.
(3) Community water systems
designated by the State to monitor for
beta particle and photon radioactivity
can not apply to the State for a waiver
from the monitoring frequencies
specified in paragraph (b)(lj or (b)(2) of
this section.
(4) Community water systems may
analyze for naturally occurring
potassium-40 beta particle activity from
the same or equivalent sample used for
the gross beta particle activity analysis.
Systems are allowed to subtract the
potassium-40 beta particle activity value
from the total gross beta particle activity
value to determine if the screening level
is exceeded. The potassium-40 beta
particle activity must be calculated by
multiplying elemental potassium
concentrations (in mg/L) by a factor of
0.82.
(5) If the gross beta particle activity
minus the naturally occurring
potassium-40 beta particle activity
exceeds the screening level, an analysis
of the sample must be performed to
identify the major radioactive
constituents present in the sample and
the appropriate doses must be
calculated and summed to determine
compliance with § 141.66(d)(l), using
the formula in § 141.66(d)(2). Doses
must also be calculated and combined
for measured levels of tritium and
strontium to determine compliance.
(6) Systems must monitor monthly at
the sampling point(s) which exceed the
maximum contaminant level in
§ 141.66(d) beginning the month after
the exceedance occurs. Systems must
continue monthly monitoring until the
system has established, by a rolling
average of 3 monthly samples, that the
MCL is being met. Systems who
establish that the MCL is being met
must return to quarterly monitoring
until they meet the requirements set
forth in paragraph (b)(l)(ii) or (b)(2)(i) of
this section.
(c) General monitoring and
compliance requirements for
radionuclides.
(l) The State may require more
frequent monitoring than specified in
paragraphs (a) and (b) of this section, or
may require confirmation samples at its
discretion. The results of the initial and
confirmation samples will be averaged
for use in compliance determinations.
(2) Each public water systems shall
monitor at the time designated by the
State during each compliance period.
(3) Compliance: Compliance with
§ 141.66 (b) through (e) will be
determined based on the analytical
result(s) obtained at each sampling
point. If one sampling point is in
violation of an MCL, the system is in
violation of the MCL.
(i) For systems monitoring more than
once per year, compliance with the MCL
is determined by a running annual
average at each sampling point. If the
average of any sampling point is greater
than the MCL, then the system is out of
compliance with the MCL.
(ii) For systems monitoring more than
once per year, if any sample result will
cause the running average to exceed the
MCL at any sample point, the system is
out of compliance with the MCL
immediately.
(iii) Systems must include all samples
taken and analyzed under the
provisions of this section in determining
compliance, even if that number is
greater than the minimum required.
(iv) If a system does not collect all
required samples -when compliance is
based on a running annual average of
quarterly samples, compliance will be
based on the running average of the
samples collected.
(v) If a sample result is less than the
detection limit, zero will be used to
calculate the annual average, unless a
gross alpha particle activity is being
used in lieu of radium-226 and/or
uranium. If the gross alpha particle
activity result is less than detection, Vz
the detection limit will be used to
calculate the annual average.
(4) States have the discretion to delete
results of obvious sampling or analytic
errors.
(5) If the MCL for radioactivity set
forth in § 141.66 (b) through (e) is
exceeded, the operator of a community
water system must give notice to the
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76748 Federal Register/Vol. 65, No. 236/Thursday, December 7, 2000/Rules and Regulations
Stale pursuant to § 141.31 and to the
public as required by subpart Q of this
part.
Subpart F—[Amended]
5. A new § 141.55 is added to subpart
F to read as follows:
§141.55 Maximum contaminant level goals
for radlonuclidcs.
MCLGs for radionuclides are as
indicated in the following table:
Contaminant
1. Combined radium-226 and radium-
228.
2. Gross alpha particle activity (ex-
cluding radon and uranium).
3. Beta particle and photon radioac-
tivity.
4. Uranium
MCLG
Zero.
Zero.
Zero.
Zero.
Subpart G—National Primary Drinking
Water Regulations: Maximum
Contaminant Levels and Maximum
Residual Disinfectant Levels
6. The heading of subpart G is revised
as set out above.
7. A new § 141.66 is added to subpart
G to read as follows:
§ 141.66 Maximum contaminant levels for
radionuclides.
(a) [Reserved]
(b} MCLfor combined radium-226 and
-228. The maximum contaminant level
for combined radium-226 and radium-
228 is 5 pCi/L. The combined radium-
226 and radium-228 value is determined
by the addition of the results of the
analysis for radium-226 and the analysis
for radium-228.
(c) MCL for gross alpha particle
activity (excluding radon and uranium).
The maximum contaminant level for
gross alpha particle activity (including
radium-226 but excluding radon and
uranium) is 15 pCi/L.
(d) MCLfor beta particle and photon
radioactivity. (1) The average annual
concentration of beta particle and
photon radioactivity from man-made
radionuclides in drinking water must
not produce an annual dose equivalent
to the total body or any internal organ
greater than 4 millirem/year (mrem/
year).
(2) Except for the radionuclides listed
in table A, the concentration of man-
made radionuclides causing 4 mrem
total body or organ dose equivalents
must be calculated on the basis of 2 liter
per day drinking water intake using the
168 hour data list in "Maximum
Permissible Body Burdens and
Maximum Permissible Concentrations
of Radionuclides in Air and in Water for
Occupational Exposure," NBS (National
Bureau of Standards) Handbook 69 as
amended August 1963, U.S. Department
of Commerce. This incorporation by
reference was approved by the Director
of the Federal Register in accordance
with 5 U.S.C. 552(a) and 1 CFR part 51.
Copies of this document are available
from the National Technical Information
Service.,.NTIS ADA 280 282, U.S.
Department of Commerce, 5285 Port
Royal Road, Springfield, Virginia 22161.
The toll-free number is 800-553-6847.
Copies may be inspected at EPA's
Drinking Water Docket, 401 M Street,
SW., Washington, DC 20460; or at the
Office of the Federal Register, 800 North
Capitol Street, NW., Suite 700,
Washington, DC. If two or more
radionuclides are present, the sum of
their annual dose equivalent to the total
body or to any organ shall not exceed
4 mrem/year.
TABLE A.—AVERAGE ANNUAL CONCENTRATIONS ASSUMED To PRODUCE: A TOTAL BODY OR ORGAN DOSE OF 4 MREM/YR
1. Radionudide .
2. Tritium
3. Strontium-90 .
Critical organ .
Total body
Bone Marrow.
pCi per liter
20,000
8
(e) MCLfor uranium. The maximum
contaminant level for uranium is 30 ug/
L.
(f) Compliance dates. (1) Compliance
dates for combined radium-226 and
-228, gross alpha particle activity, gross
beta particle and photon radioactivity,
and uranium: Community water systems
must comply with the MCLs listed in
paragraphs (b), (c), Cd), and (e) of this
section beginning December 8,2003 and
compliance shall be determined in
accordance with the requirements of
§§ 141.25 and 141.26. Compliance with
reporting requirements for the
radionuclides under appendix A to
subpart O and appendices A and B to
subpart Q is required on December 8,
2003.
(g) Best available technologies (BATs)
for radionuclides. The Administrator,
pursuant to section 1412 of the Act,
hereby identifies as indicated in the
following table the best technology
available for achieving compliance with
the maximum contaminant levels for
combined radium-226 and -228,
uranium, gross alpha particle activity,
and beta particle and photon
radioactivity.
TABLE B.—BAT FOR COMBINED RADiuw-226 AND RADiUM-228, URANIUM, GROSS ALPHA PARTICLE ACTIVITY, AND BETA
PARTICLE AND PHOTON RADIOACTIVITY
Contaminant
1. Combined r?*dhim~??6 and radium-???*
3. Gross alpha particle activity (excluding Radon and Uranium)
4. Beta particle and photon radioactivity
BAT
Ion exchange reverse osmosis lime softening
Reverse osmosis.
Ion exchange reverse osmosis
(h) Small systems compliance
technologies list for radionuclides.
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Federal Register/Vol. 65, No. 236/Thursday, December 7. 2000/Rules and Regulations 76749
TABLE c.—LIST OF SMALL SYSTEMS COMPLIANCE TECHNOLOGIES FOR RADIONUCLIDES AND LIMITATIONS TO USE
Unit technologies
-
2 Point of use (POU2) IE
4 POU2 RO
6 Green sand filtration
filtration.
11. Enhanced coagulation/filtration
Limitations
(see foot-
notes)
W
M
/c\
(M
(d)
(c)
M
M (M
C)
Operator skill level required 1
Intermediate
Basic "...
Advanced
Basic
Advanced
Basic.
Intermediate to Advanced
Basic to intermediate
Advanced
Advanced
Raw water quality range and
considerations.1
All ground waters.
All ground waters.
Surface waters usually require pre-filtra-
tion.
Surface waters usually require pre-filtra-
tion.
All waters.
Ground waters with suitable water quality.
All ground waters.
All ground waters.
All ground waters: competing anion con-
centrations may affect regeneration fre-
quency.
Can treat a wide range of water qualities.
i National Research Council (NRC). Safe Water from Every Tap: Improving Water Service to Small Communities. National Academy Press.
2 A POU or "point-of-use" technology is a treatment device installed at a single tap used for the purpose of reducing contaminants in drinking
water at that one tap. POU devices are typically installed at the kitchen tap. See the April 21, 2000 NODA for more details.
Limitations Footnotes: Technologies for Radionuclides:
•The regeneration solution contains high concentrations of the contaminant ions. Disposal options should be carefully considered before
bWhen POU devices are used for compliance, programs for long-term operation, maintenance, and monitoring must be provided by water util-
ity to ensure proper performance. „„ ,. -^^ j -u j • u.
'Reject water disposal options should be carefully considered before choosing this technology. See other RO limitations descnbed in the
SWTR Compliance Technologies Table. . «.•*_•. i . i
dThe combination of variable source water quality and the complexity of the water chemistry involved may make this technology too complex
for small surface water systems.
c Removal efficiencies can vary depending on water quality. .
This technology may be very limited in application to small systems. Since the process requires static mixing, detention basins, and tiltration,
it is most applicable to systems with sufficiently high sulfate levels that already have a suitable filtration treatment train in place.
KThis technology is most applicable to small systems that already have filtration in place. _..,.•..
"Handling of chemicals required during regeneration and pH adjustment may be too difficult for small systems without an adequately trained
operator.
'Assumes modification to a coagulation/filtration process already in place.
TABLE D.—COMPLIANCE TECHNOLOGIES BY SYSTEM SIZE CATEGORY FOR RADIONUCLIDE NPDWR's
Contaminant
1. Combined radium-226 and radium-228
3. Beta particle activity and photon activity
4. Uranium
Compliance technologies n for system size categories
(population served)
25-500
1,2,3,4, 5.6,7,8,9
3 4
1, 2, 3, 4
1,2.4, 10, 11
501-3,300
1, 2.3,4.5.6.7.8. 9
3, 4
1, 2, 3, 4
1,2. 3. 4. 5. 10, 11
3,300-10.000
1, 2. 3, 4, 5, 6. 7. 8, 9.
3,4.
1.2,3,4.
1,2,3,4,5,10. 11.
Note: ' Numbers correspond to those technologies found listed in the table C of 141.66(h).
Subpart O—[Amended]
8. The table in appendix A to subpart
O is amended under the heading
"Radioactive contaminants" by revising (pCi/l)", and "Combined radium (pCi/
the entries for "Beta/photon emitters I)" and adding & new entry for
(mrem/yr)", "Alpha emitters "Uranium (Ay /L)" to read as follows:
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1
76750 Federal Register/Vol. 65, No. 236/Thursday, December 7, 2000/Rules and Regulations.
Appendix A to Subpart O—Regulated Contaminants
Contaminant units
Traditional MCL
in mg/L
To con-
vert for
OCR,
multiply
by
MCL in
CCR
units
MCLG
Major sources in
drinking water
Health effects language
Radioactive contami-
nants:
Beta/photon 4 mrem/yr .
emitters
(mremyyr).
Alpha emitters 15 pCi/L .
(PCi/L).
Combined ra- 5 pCi/L
dium (pCi/L).
Uranium Iff, A.) 30 ug/L
15
30
0 Decay of natural and
man-made depos-
its.
0 Erosion of natural
deposits.
0 Erosion of natural
deposits.
0 Erosion of natural
deposits.
Certain minerals are radioactive and may
emit forms of radiation known as pho-
tons and- beta radiation. Some people
who drink water containing beta par-
ticle and photon radioactivity in excess
of the MCL over many years may have
an increased risk of getting cancer.
Certain minerals are radioactive and may
emit a form of radiation known as
alpha radiation. Some people who
drink water containing alpha emitters in
excess of the MCL over many years
may have an increased risk of getting
cancer.
Some people who drink water containing
radium-226 or -228 in excess of the
MCL over many years may have an in-
creased risk of getting cancer.
Some people who drink water containing
uranium in excess of the MCL over
many years may have an increased
risk of getting cancer and kidney tox-
icity.
Subpart Q—[Amended] a. Revising entries 1, 2, and 3;
9. Appendix A to subpart Q under I.F. b- Addin8 entry 4;
"Radioactive contaminants" is amended c. Redesignating endnotes 9 through
by: 17 as endnotes 11 through 19; and
d. Adding new endnotes 9 and 10.
Appendix A to Subpart Q—NPDWR Violations and Other Situations Requiring Public Notice1
Contaminant
MCL/MRDUTT Violations2
Tier of pub-
lic notice Citation
required
Monitoring and testing
procedure violations
Tier of pub-
lic notice Citation
required
I. Violations of National Primary Drinking Water Regulations (NPDWR)'
F. Radioactive contaminants
1. Beta/photon emitters
2. Alpha emitters
3. Combined radium (226 and 228)
4. Uranium ,
* * *
2 141 66(d)
2 141 66(c)
2 141 66(b)
* * *
3
3
3
10*3
141 yttfsti
141.26(b)
141 Jlfa}
141.26(a)
141 25(a)
141.26(a)
141.26(a)
*
Appendix A—Endnotes
1. Violations and other situations not listed
in this table [e.g.. reporting violations and
failure to prepare Consumer Confidence
Reports), do not require notice, unless
otherwise determined by the primary agency.
Primacy agencies may. at their option, also
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Federal Register/Vol. 65. No. 236/Thursday, December 7. 2000/Rules and Regulations 76751
10. Appendix B to Subpart Qis amended
require a more stringent public notice tier
(e.g.. Tier 1 instead of Tier 2 or Tier 2 instead
of Tier 3) for specific violations and •
situations listed in this Appendix, as
authorized under Sec. 141.202(a) and Sec.
141.203(a).
2. MCL—Maximum contaminant level,
MKDL—Maximum residual disinfectant
level, TT—Treatment technique.
3. The term Violations of National Primary
Drinking Water Regulations (NPDWR) is used
here to include violations of MCL, MRDL,
treatment technique, monitoring, and testing
procedure requirements.
9. The uranium MCL Tier 2 violation
citations are effective December 8,2003 for
all community water systems.
10. The uranium Tier 3 violation citations
are effective December 8,200$ for all
community water systems.
by:
a. Redesignating entries 79 through 84 and
86 through 88 as 80 through 85 and 87
through 89, respectively, and entries 85a and
85b as 86a and 86b, respectively;
b. Adding a new entry 79 for uranium
under "G. Radioactive contaminants";
c. Redesignating endnote entries 16
through 21 as 17 through 22: and
d. adding a new endnote 16.
Appendix B to Subpart Q—Standard Health Effects Language for Public Notification
Contaminant
MCLG' mg/L MCL2 mg/L
Standard health effects language for public notification
National Primary Drinking
Water Regulations (NPDWR)
G. Radioactive contaminants
79. Uranium16 - Zero
30
Some people who drink water containing uranium in excess of the MCL over
many years may have an increased risk of getting cancer and kidney tox-
icity.
Appendix B—Endnotes
1. MCLG—Maximum contaminant level
goal
2. MCL—Maximum contaminant level
16. The uranium MCL is effective
December 8, 2003 for all community water
systems.
PART 142—NATIONAL PRIMARY
DRINKING WATER REGULATIONS
IMPLEMENTATION
1. The authority citation for part 142
continues to read as follows:
Authority: 42 U.S.C. 300f, 300g-l. 300g-2,
300g-3. 300g-4, 300g-5, 300g-6, 300J-4,
300J-9. and 300J-11.
Subpart B—Primary Enforcement
Responsibility
2. Section 142.16 is amended by
adding and reserving paragraphs (i), (j),
and (k) and adding a new paragraph (1)
to read as follows:
§142.16 Special primacy requirements.
*****
(i)-(k) [Reserved]
(1) An application for approval of a
State program revision for radionuclides
which adopts the requirements
specified in§141.26(a)(2)(ii)(C) of this
chapter must contain the following (in
addition to the general primacy
requirements enumerated in this part,
including that State regulations be at
least as stringent as the Federal
requirements):
(1) If a State chooses to use
grandfathered data in the manner
described in § 141.26(a)C2)(ii)(C) of this
chapter, then the State must describe
the procedures and criteria which it will
use to make these determinations
(whether distribution system or entry
point sampling points are used).
(i) The decision criteria that the State
will use to determine that data collected
in the distribution system are
representative of the drinking water
supplied from each entry point to the
distribution system. These
determinations must consider:
(A) All previous monitoring data.
(B) The variation in reported activity
levels.
(C) Other factors affecting the
representativeness of the data (e.g.
geology).
(ii) [Reserved]
(2) A monitoring plan by which the
State will assure all systems complete
the required monitoring within the
regulatory deadlines. States may update
their existing monitoring plan or use the
same monitoring plan submitted for the
requirements in § 142.16(e)(5) under the
national primary drinking water
regulations for the inorganic and organic
contaminants (i.e. the phase H/V rules).
States may note in their application any
revision to an existing monitoring plan
or note that the same monitoring plan
will be used. The State must
demonstrate that the monitoring plan is
enforceable under State law. :
Subpart G—[Amended]
3: Section 142.65 is added to read as
follows.
§ 142.65 Variances and exemptions from
the maximum contaminant levels for
radionuclides.
(a)(l) Variances and exemptions from
the maximum contaminant levels for
combined radium-226 and radium-228,
uranium, gross alpha particle activity
(excluding Radon and Uranium), and
beta particle and photon radioactivity.
(i) The Administrator, pursuant to
section 1415(a)(l)(A) of the Act, hereby
identifies the following as the best
available technology, treatment
techniques, or other means available for
achieving compliance with the
maximum contaminant levels for the
radionuclides listed in § 141.66(b), (c),
(d), and (e) of this chapter, for the
purposes of issuing variances and
exemptions, as shown in Table A to this
paragraph.
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76752 Federal Register/Vol. 65, No. 236/Thursday, December 7, 2000/Rules and Regulations
TABLE A. — BAT FOR RADIONUCLIDES LISTED IN § 141.66
Contaminant
Combined rad!iirn-9PR and radinm-9?R ,
Uranium ....
Gross alpha particle activity (excluding radon and uranium)
Beta particle and photon radioactivity
BAT
Ion exchange, reverse osmosis, lime softening.
Ion exchange, reverse osmosis, lime softening, coagulation/filtration.
Reverse osmosis.
Ion exchange, reverse osmosis.
(ii) In addition, the Administrator
hereby identifies the following as the
best available technology, treatment
maximum contaminant levels for the
radionuclides listed in § 141.66(b), (c),
(d), and (e) of this chapter, for the
techniques, or other means available for purposes of issuing variances and
systems, defined here as those serving
10,000 persons or fewer, as shown in
Table C to this paragraph.
achieving compliance with the
exemptions to small drinking water
TABLE B.—LIST OF SMALL SYSTEMS COMPLIANCE TECHNOLOGIES FOR RADIONUCLIDES AND LIMITATIONS TO USE
Unit technologies
1. Ion exchange (IE) .'.
2. Point of use (POU2) IE
3. Reverse osmosis (RO)
4. POU 2 RO
5. Lima softening
6. Green sand filtration
7. Co-precipitation with barium sulfate
8. Electrodialysis/electrodialysis reversal
3. Pro-formed hydrous manganese oxide
ffflralion.
10. Activated alumina
11. Enhanced coagulation/filtration
Limitations
(see foot-
notes)
(a)
(b)
(c)
(b)
(d)
(e)
o
(3)
(a), (h)
C)
Operator skill level required '
Intermediate
Basic
Advanced
Basic
Advanced
Basic •
Intermediate to Advanced '..
Basic to Intermediate
Intermediate
Advanced
Advanced
Raw water quality range &
considerations1
tion.
tion.
All ground waters
centrations may affect regeneration fre-
quency.
Can treat a wide range of water qualities.
1 National Research Council (NRC). Safe Water from Every Tap: Improving Water Service to Small Communities. National Academy Press
Washington. D.C. 1997. • ••
2A POU, or "point-of-use" technology is a treatment device installed at a single tap used for the purpose of reducing contaminants in drinking
water at that one tap. POU devices are typically installed at the kitchen tap. See the April 21, 2000 NODA for more details.
Limitations Footnotes: Technologies for Radionuclides:
•The regeneration solution contains high concentrations of the contaminant ions. Disposal options should be carefully considered before
choosing this technology.
bWheo POU devices are used for compliance, programs for long-term operation, maintenance, and monitoring must be provided by water util-
ity to ensure proper performance.
cReJect water disposal options should be carefully considered before choosing this technology. See other RO limitations described in the
SWTR compliance technologies table.
dThe combination of variable source water quality and the complexity of the water chemistry involved may make this technology too complex
for small surface water systems.
"Removal efficiencies can vary depending on water quality.
'This technology may be very limited in application to small systems. Since the process requires static mixing, detention basins, and filtration,
it ts most applicable to systems with sufficiently high sulfate levels that already have a suitable filtration treatment train in place.
oThis technology Is most applicable to small systems that already have filtration in place.
h Handling of chemicals required during regeneration and pH adjustment may be too difficult for small systems without an adequately trained
operator. . •
'Assumes modification to a coagulation/filtration process already in place.
TABLE C.—BAT FOR SMALL COMMUNITY WATER SYSTEMS FOR THE RADIONUCLIDES LISTED IN § 141.66
Contaminant
Combined radium-226 and radium-228
Gross alpha particle activity
Beta particle activity and photon activity
Uranium
Compliance technologies 1 for system size categories (population served)
25-500
1, 2, 3, 4, 5, 6, 7, 8, 9
3, 4
1.2,3,4
1,2, 4, 10, 11
501-3,300
1,2, 3,4, 5, 6, 7, 8,9
3 4
1, 2, 3, 4
1, 2, 3,4,5, 10, 11
3,300-10,000
1, 2, 3,4, 5,6,7, 8, 9.
3,4.
1,2,3,4.
1, 2, 3, 4, 5, 10, 11.
1 Note: Numbers correspond to those technologies found listed in the table B to this paragraph.
(2) A State shall require community
water systems to install and/or use any
treatment technology identified in Table water systems (those serving 10,000
A to this section, or in the case of small persons or fewer), Table B and Table C
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Federal Register/Vol. 65, No. 236/Thursday, December 7, 2000/Rules and Regulations 76753
of this section, as a condition for
granting a variance except as provided
in paragraph (a)(3) of this section. If,
after the system's installation of the
treatment technology, the system cannot
meet the MCL, that system shall be
eligible for a variance under the
provisions of section 1415(a)(l)(A) of
the Act.
(3) If a community water system can
demonstrate through comprehensive
engineering assessments, •which may
include pilot plant studies, that the
treatment technologies identified in this
section would only achieve a de
minimus reduction in the contaminant
level, the State may issue a schedule of
compliance that requires the system
being granted the variance to examine
other treatment technologies as a
condition of obtaining the variance.
(4) If the State determines that a
treatment technology identified under
paragraph (a)(3) of this section is
technically feasible, the Administrator
or primacy State may require the system
to install and/or use that treatment
technology in connection with a
compliance schedule issued under the
provisions of section 1415(a)(l)(A) of
the Act. The State's determination shall
be based upon studies by the system
and other relevant information.
(5) The State may require a
community water system to use bottled
water, point-of-use devices, point-of-
entry devices or other means as a
condition of granting a variance or an
exemption from the requirements of
§ 141.66 of this chapter, to avoid an
unreasonable risk to health.
(6] Community water systems that use
bottled water as a condition for
receiving a variance or an exemption
from the requirements of § 141.66 of this
chapter must meet the requirements
specified in either § 142.62(g)(l) or
§142.62(g)(2)and(gK3).
(7) Community water systems that use
pointof-use or point-of-entry devices as
a_condition for obtaining a variance or
an exemption from the radionuclides
NPDWRs must meet the conditions in
§142.62(h)(l) through (h)(6).
[FR Doc. 00-30421 Filed 12-6-00; 8:45 am]
BILLING CODE 6560-50-U
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