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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76730     Federal Register/Vol. 65, No.  236/Thursday, December 7, 2000/RuIes and Regulations
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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           Federal Register/Vol. 65, No.  236/Thursday, December 7, 2000/Rules and Regulations     76731
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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