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National Primary Drinking Water Regulations; Radon-222; Proposed Rule
Federal Register Document
Related Material
[Federal Register: November 2, 1999 (Volume 64, Number 211)]
[Proposed Rules]
[Page 59245-59294]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr02no99-35]
[[Page 59245]]
_______________________________________________________________________
Part II
Environmental Protection Agency
_______________________________________________________________________
40 CFR Parts 141 and 142
National Primary Drinking Water Regulations; Radon-222; Proposed Rule
[[Page 59246]]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Parts 141 and 142
[WH-FRL-6462-8]
RIN 2040-AA94
National Primary Drinking Water Regulations; Radon-222
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice of proposed rulemaking.
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SUMMARY: In this action, the Environmental Protection Agency (EPA) is
proposing a multimedia approach to reducing radon risks in indoor air
(where the problem is greatest), while protecting public health from
the highest levels of radon in drinking water. Most radon enters indoor
air from soil under homes and other buildings. Only approximately 1-2
percent comes from drinking water. The Agency is proposing a Maximum
Contaminant Level Goal (MCLG) and National Primary Drinking Water
Regulations (NPDWR) for radon-222 in public water supplies. Under the
framework set forth in the 1996 amendments to the SDWA, EPA is also
proposing an alternative maximum contaminant level (AMCL) and
requirements for multimedia mitigation (MMM) programs to address radon
in indoor air. Public water systems (PWS) are defined in the Safe
Drinking Water Act (SDWA). This proposed rule applies to community
water systems (CWS), a subset of PWSs. Under the proposed rule, CWSs
may comply with the AMCL if they are in States that develop an EPA-
approved MMM program or, in the absence of a State program, develop a
State-approved CWS MMM program. This approach is intended to encourage
States, Tribes, and CWSs to reduce the health risk of radon in the most
cost-effective way. The Agency is also proposing a maximum contaminant
level (MCL) for radon-222, to apply to CWSs in non-MMM States that
choose not to implement a CWS MMM program. The proposal also includes
monitoring, reporting, public notification, and consumer confidence
report requirements for radon-222 in drinking water.
DATES: EPA must receive public comments, in writing, on the proposed
regulations by January 3, 2000.
ADDRESSES: You may send written comments to the Radon-222, W-99-08
Comments Clerk, Water Docket (MC-4101); U.S. Environmental Protection
Agency; 401 M Street, SW., Washington, DC 20460. Comments may be hand-
delivered to the Water Docket, U.S. Environmental Protection Agency;
401 M Street, SW., East Tower Basement, Washington, DC 20460. Comments
may be submitted electronically to owdocket@epamail.epa.gov. Electronic
comments must be submitted as an ASCII, WP6.1, or WP8 file avoiding the
use of special characters and any form of encryption. Electronic
comments must be identified by the docket number W-99-08. Comments and
data will also be accepted on disks in WP6.1, WP8, or ASCII format.
Electronic comments on this action may be filed online at many Federal
Depository libraries.
Please submit a copy of any references cited in your comments.
Facsimiles (faxes) cannot be accepted. EPA would appreciate one
original and three copies of your comments and enclosures (including
any references). Commenters who would like EPA to acknowledge receipt
of their comments should include a self-addressed, stamped envelope.
The proposed rule and supporting documents, including public
comments, are available for review in the Water Docket at the address
listed previously. The Docket also has several of the key supporting
documents electronically available as PDF files. For information on how
to access Docket materials, please call (202) 260-3027 between 9 a.m.
and 3:30 p.m. Eastern Time, Monday through Friday.
FOR FURTHER INFORMATION CONTACT: For general information on radon in
drinking water, contact the Safe Drinking Water Hotline, phone (800)
426-4791. The Safe Drinking Water Hotline is open Monday through
Friday, excluding Federal holidays, from 9 a.m. to 5:30 p.m. Eastern
Time. For technical inquiries regarding the proposed regulations,
contact Sylvia Malm, Office of Ground Water and Drinking Water, U.S.
Environmental Protection Agency (mailcode 4607), 401 M Street, SW,
Washington DC, 20460. Phone: (202) 260-0417. E-mail:
malm.sylvia@epa.gov. For inquiries regarding the proposed multimedia
mitigation program, contact Anita Schmidt, Office of Radiation and
Indoor Air, U.S. Environmental Protection Agency, (mailcode 6609J), 401
M Street, S.W, Washington, DC, 20460. Phone: (202) 564-9452. E-mail:
schmidt.anita@epa.gov. For general information on radon in indoor air,
contact the Radon Hotline at 1-800-SOS-RADON (1-800-767-7236).
SUPPLEMENTARY INFORMATION:
Potentially Regulated Entities
Potentially regulated entities include community water systems
using ground water or mixed ground and surface water.
The following table lists potentially regulated entities. This
table is not intended to be exhaustive, but rather provides a guide for
readers regarding entities likely to be regulated by this action. This
table lists the types of entities that EPA is now aware of that could
potentially be regulated by this action. Other entities not listed in
the table could also be regulated. To determine whether your
organization is affected by this action, you should carefully examine
the proposed applicability criteria in section 40 CFR parts
141.20(b)(1) and Section IV of the preamble. If you have questions
regarding the applicability of this action to a particular entity,
consult Sylvia Malm who is listed in the preceding FOR FURTHER
INFORMATION CONTACT section.
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Examples of potentially
Category regulated entities
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Industry.................................. Privately owned/operated
community water supply
systems using ground water
or mixed ground water and
surface water.
State, Tribal, and Local Government....... State, Tribal, or local
government-owned/operated
water supply systems using
ground water or mixed
ground water and surface
water.
Federal Government........................ Federally owned/operated
community water supply
systems using ground water
or mixed ground water and
surface water.
------------------------------------------------------------------------
Abbreviations Used in This Proposal
AMCL: Alternative Maximum Contaminant Level
BAT: Best Available Technology
BEIR: Committee on the Biological Effects of Ionizing Radiation. The
Committee on Health Risks of Exposure on Radon that conducted the
National Research Council Biological Effects of Ionizing Radiation
(BEIR) VI Study (NAS 1999a). The committee is formed by the Radiation
Effect Research/Commission on Life Sciences/National Research Council/
National Academy of Sciences.
CFR: Code of Federal Regulations
CWS: Community Water System
EF: Equilibrium Factor
EPA: U.S. Environmental Protection Agency
FR: Federal Register
GAC: Granular Activated Carbon
[[Page 59247]]
HRRCA: Health Risk Reduction and Cost Analysis
IOC: Inorganic Contaminant
LSC: Liquid Scintillation Counting
MCL: Maximum Contaminant Level
MCLG: Maximum Contaminant Level Goal
MMM: Multimedia Mitigation
NAS: National Academy of Sciences
NAS Radon in Drinking Water Committee: The Committee on Risk Assessment
of Exposure to Radon of the Drinking Water that conducted the National
Research Council Risk Assessment of Radon in Drinking Water Study (NAS
1999b). The committee is formed by the Board of Radiation Effect
Research of the Commission on Life Sciences of the National Research
Council, National Academy of Sciences.
NELAC: National Environmental Laboratory Accreditation Conference
NIST: National Institute of Standards and Technology
NIRS: National Inorganics and Radionuclides Survey
NPDWR: National Primary Drinking Water Regulation
NPRM: Notice of Proposed Rulemaking
NTNC: Non-Transient, Non-Community
OGWDW: Office of Ground Water and Drinking Water
OMB: Office of Management and Budget
PBMS: Performance-Based Measurement System
PE: Performance Evaluation
PT: Proficiency Testing
POE: Point-of-Entry
POU: Point-of-Use
PRA: Paperwork Reduction Act
PWS: Public Water System
pCi/L: Picocuries per Liter
RFA: Regulatory Flexibility Act
SAB: Science Advisory Board
SBA: Small Business Administration
SBO: Small Business Ombudsman
SBREFA: Small Business Regulatory Enforcement and Fairness Act
SDWA: Safe Drinking Water Act
SDWIS: Safe Drinking Water Information System
SIRG: State Indoor Radon Grant
SSCT: Small Systems Compliance Technology
SSVT: Small Systems Variance Technology
SMF: Standardized Monitoring Framework
UMRA: Unfunded Mandates Reform Act
URTH: Unreasonable Risks to Health
WL: Working Level
WLM: Working Level Month
Table of Contents
I. Summary: What Does Today's Proposed Rulemaking Mean for My Water
System?
A. Why is EPA Proposing to Regulate Radon in Drinking Water?
B. What is Radon?
C. What are the Health Concerns from Radon in Air and Water?
D. Does this Regulation Apply to My Water System?
E. How Will this Regulation Protect Public Health?
F. How Will the Multimedia Mitigation (MMM) Program Work?
G. What are the Proposed Limits for Radon in Drinking Water?
H. What is the Proposed Best Available Technology (BAT) for
Treating Radon in Drinking Water?
I. What Analytical Methods are Recommended?
J. Where and How Often Must I Test My Water for Radon?
K. May I Use Point-of-Use (POU) Devices, Point-of-Entry (POE)
Devices, or Bottled Water to Comply with this Regulation?
L. May I Get More Time or Use a Cheaper Treatment? Variances and
Exemptions
M. What are State Primacy, Record Keeping, and Reporting
Requirements?
N. How are Tribes Treated in this Proposal?
Statutory Requirements and Regulatory History
II. What Does the Safe Drinking Water Act Require the EPA to Do When
Regulating Radon in Drinking Water?
A. Withdraw the 1991 Proposed Regulation for Radon
B. Arrange for a National Academy of Sciences Risk Assessment.
C. Set an MCLG, MCL, and BAT for Radon-222
D. Set an Alternative MCL (AMCL) and Develop Multimedia
Mitigation (MMM) Program Plan Criteria
E. Evaluate Multimedia Mitigation Programs Every Five Years
III. What Actions Has EPA Taken on Radon in Drinking Water Prior to
This Proposal?
A. Regulatory Actions Prior to 1991
B. The 1991 NPRM
C. 1994 Report to Congress: Multimedia Risk and Cost Assessment
of Radon
D. 1997 Withdrawal of the 1991 NPRM for Radon-222
E. 1998 SBREFA Small Business Advocacy Review Panel for Radon
F. 1999 HRRCA for Radon in Drinking Water
Requirements
IV. To Which Water Systems Does this Regulation Apply?
V. What is the Proposed Maximum Contaminant Level Goal (MCLG) for
Radon?
A. Approach to Setting the MCLG
B. MCLG for Radon in Drinking Water
VI. What Must a State or Community Water System Have In Its
Multimedia Mitigation Program Plan?
A. What are the Criteria?
B. Why Will MMM Programs Get Risk Reduction Equal or Greater
Than Compliance with the MCL?
C. Implementation of an MMM Program in Non-Primacy States
D. Implementation of the MMM Program in Indian Country
E. CWS Role in State MMM Programs
F. Local CWS MMM Programs in Non-MMM States and State Role in
Approval of CWS MMM Program Plans
G. CWS Role in Communicating to Customers
H. How Did EPA Develop These Criteria?
I. Background on the Existing EPA and State Indoor Radon
Programs
VII. What are the Requirements for Addressing Radon in Water and
Radon in Air? MCL, AMCL and MMM
A. Requirements for Small Systems Serving 10,000 People or Less
B. Requirements for Large Systems Serving More Than 10,000
People
C. State Role in Approval of CWS MMM Program Plans
D. Background on Selection of MCL and AMCL
E. Compliance Dates
VIII. What are the Requirements for Testing for and Treating Radon
in Drinking Water?
A. Best Available Technologies (BATs), Small Systems Compliance
Technologies (SSCTs), and Associated Costs
B. Analytical Methods
C. Laboratory Approval and Certification
D. Performance-Based Measurement System (PBMS)
E. Proposed Monitoring and Compliance Requirements for Radon
IX. State Implementation
A. Special State Primacy Requirements
B. State Record Keeping Requirements
C. State Reporting Requirements
D. Variances and Exemptions
E. Withdrawing Approval of a State MMM Program
X. What Do I Need to Tell My Customers? Public Information
Requirements
A. Public Notification
B. Consumer Confidence Report
Risk Assessment and Occurrence
XI. What is EPA's Estimate of the Levels of Radon in Drinking Water?
A. General Patterns of Radon Occurrence
B. Past Studies of Radon Levels in Drinking Water
C. EPA's Most Recent Studies of Radon Levels in Ground Water
D. Populations Exposed to Radon in Drinking Water
XII. What Are the Risks of Radon in Drinking Water and Air?
A. Basis for Health Concern
B. Previous EPA Risk Assessment of Radon in Drinking Water
C. NAS Risk Assessment of Radon in Drinking Water
D. Estimated Individual and Population Risks
E. Assessment by National Academy of Sciences: Multimedia
Approach to Risk Reduction
Economics and Impacts Analysis
XIII. What is the EPA's Estimate of National Economic Impacts and
Benefits?
A. Safe Drinking Water Act (SDWA) Requirements for the HRRCA
B. Regulatory Impact Analysis and Revised Health Risk Reduction
and Cost Analysis (HRRCA) for Radon
[[Page 59248]]
C. Baseline Analysis
D. Benefits Analysis
E. Cost Analysis
F. Economic Impact Analysis
G. Weighing the Benefits and Costs
H. Response to Significant Public Comments on the February 1999
HRRCA
XIV. Administrative Requirements
A. Executive Order 12866: Regulatory Planning and Review
B. Regulatory Flexibility Act (RFA)
C. Unfunded Mandates Reform Act (UMRA)
D. Paperwork Reduction Act (PRA)
E. National Technology Transfer and Advancement Act (NTTAA)
F. Executive Order 12898: Environmental Justice
G. Executive Order 13045: Protection of Children from
Environmental Health Risks and Safety Risks
H. Executive Order on Federalism
I. Executive Order 13084: Consultation and Coordination with
Indian Tribal Governments
J. Request for Comments on Use of Plain Language
Stakeholder Involvement
XV. How has the EPA Provided Information to Stakeholders in
Development of this NPRM?
A. Office of Ground Water and Drinking Water Website
B. Public Meetings
C. Small Entity Outreach
D. Environmental Justice Initiatives
E. AWWA Radon Technical Work Group
Background
XVI. How Does EPA Develop Regulations to Protect Drinking Water?
A. Setting Maximum Contaminant Level Goal and Maximum
Contaminant Level
B. Identifying Best Available Treatment Technology
C. Identifying Affordable Treatment Technologies for Small
Systems
D. Requirements for Monitoring, Quality Control, and Record
Keeping
E. Requirements for Water Systems to Notify Customers of Test
Results if Not in Compliance
F. Approval of State Drinking Water Programs to Enforce Federal
Regulations
XVII. Important Technical Terms
XVIII. References
Appendix I to the Preamble: What are the Major Public Comments on the
1991 NPRM and How has the EPA Addressed Them in this Proposal?
A. General Issues
B. Statutory Authority and Requirements
C. Radon Occurrence
D. Radon Exposure and Health Effects
E. Maximum Contaminant Level
F. Analytical Methods
G. Treatment Technologies and Cost
H. Compliance Monitoring
I. Summary: What Does Today's Proposed Rulemaking Mean for My Water
System?
A. Why Is EPA Proposing To Regulate Radon in Drinking Water?
The proposed National Primary Drinking Water Regulation (NPDWR) for
radon in drinking water is based on a multimedia approach designed to
achieve greater risk reduction by addressing radon risks in indoor air,
with public water systems providing protection from the highest levels
of radon in their ground water supplies. The framework for this
proposal is set out in the Safe Drinking Water Act as amended in 1996
(SDWA), which provides for a multimedia approach for addressing the
public health risks from radon in drinking water and radon in indoor
air from soil. This statutory-based framework reflects the
characteristics uniquely specific to radon among drinking water
contaminants: that the relative cost-effectiveness of reducing risk
from exposure to this contaminant is substantially greater for a non-
drinking water source of exposure--indoor air--than it is from drinking
water. Accordingly, SDWA directs the Environmental Protection Agency
(EPA) to promulgate a maximum contaminant level (MCL) for radon in
drinking water, but also to make available a higher alternative maximum
contaminant level (AMCL) accompanied by a multimedia mitigation (MMM)
program to address radon risks in indoor air. Further, in setting the
MCL, EPA is to take into account the costs and benefits of programs
that control radon in indoor air (SDWA 1412(b)(13)(E)).
B. What Is Radon?
Radon's Physical Properties
Throughout this preamble, ``radon'' refers to the specific isotope
radon-222. Radon is a naturally occurring gas formed from the
radioactive decay of uranium-238. Low concentrations of uranium and its
other decay products, specifically radium-226, occur widely in the
earth's crust, and thus radon is continually being generated, even in
soils in which there is no man-made radioactive contamination. Radon is
colorless, odorless, tasteless, chemically inert, and radioactive. A
portion of the radon released through radioactive decay moves through
air or water-filled pores in the soil to the soil surface and enters
the air, while some remains below the surface and dissolves in ground
water (water that collects and flows under the ground's surface).
Because radon is a gas, when water that contains radon is exposed
to the air, the radon will tend to be released into the air. Therefore,
radon is usually present in only low amounts in rivers and lakes. If
ground water is supplied to a house, radon in the water will tend to be
released into the air of the house via various water uses. Thus
presence of radon in drinking water supplies leads to exposure via both
oral route (ingesting water containing radon) and inhalation route
(breathing air containing both radon and radon decay products released
from water used in the house such as for cooking and washing).
Radon itself also decays, emitting ionizing radiation in the form
of alpha particles, and transforms into decay products, or ``progeny''
radioisotopes. It has a half-life of about four days and decays into
short-lived progeny. Unlike radon, the progeny are not gases, and can
easily attach to and be transported by dust and other particles in air.
The decay of progeny continues until stable, non-radioactive progeny
are formed. At each step in the decay process, radiation is released.
C. What Are the Health Concerns From Radon in Air and Water?
National and international scientific organizations have concluded
that radon causes lung cancer in humans. The primary risk is lung
cancer from radon entering indoor air from soil under homes. Tap water
is a smaller source of radon in air; however, breathing radon released
to air from household water uses also increases the risk of lung
cancer, and consumption of drinking water containing radon presents a
smaller risk of internal organ cancers, primarily stomach cancer.
In most cases, radon in soil under homes is the biggest source of
exposure and radon from tap water will be a small source of radon in
indoor air.
The U.S. Surgeon General has warned that indoor radon (from soil)
is the second leading cause of lung cancer (USEPA 1988b). The National
Academy of Sciences (NAS 1999a) estimates that radon from soil causes
about 15,000 to 22,000 (using two different approaches) lung cancer
deaths each year in the U.S. If you smoke and your home has high indoor
radon levels, your risk of lung cancer is especially high. EPA and the
U.S. Surgeon General recommend testing all homes below the third floor.
The NAS report mandated by the 1996 SDWA identifies the same unit
risk associated with radon in drinking water compared with previous EPA
analyses. Based on the NAS risk assessment and an updated EPA
[[Page 59249]]
occurrence analysis, the Agency estimates that uncontrolled levels of
radon in public drinking water supplies cause 168 fatal cancers each
year in the U.S. However, radon in domestic drinking water generally
contributes a very small part (about 1-2 percent) of total radon
exposure from indoor air. The NAS estimated that about 89 percent of
the fatal cancers caused by radon in drinking water were due to lung
cancer from inhalation of radon released to indoor air, and about 11
percent were due to stomach cancer from consuming water containing
radon (NAS 1999b).
D. Does This Regulation Apply to My Water System?
The regulation for radon in drinking water and the multimedia
approach proposed in this action would apply to all community public
water systems (CWSs) that use ground water or mixed ground and surface
water. The proposed regulation would not apply to non-transient non-
community (NTNC) public water supplies, nor to transient public water
supplies.
E. How Will This Regulation Protect Public Health?
Given the much greater potential for risk reduction in indoor air
and years of experience with radon mitigation programs, EPA expects
that greater overall risk reduction will result from this proposal than
from an approach which solely addresses radon in public drinking water
supplies. The proposed regulation for radon in drinking water is
intended to promote a more cost-effective multimedia approach to reduce
radon risks, particularly for small systems with limited resources, and
to reduce the highest levels of radon in drinking water. This
determination to have a strong and effective multimedia radon program
to address radon in indoor air is consistent with the SDWA framework
for multimedia radon programs and the SDWA expectation that EPA would
give significant weight to the risk findings of the NAS report, which
confirm the health risks of radon in drinking water, and the much
greater risks from radon in indoor air arising from soil under homes.
F. How Will the Multimedia Mitigation (MMM) Program Work?
The multimedia mitigation (MMM) program is modeled on the National
Indoor Radon Program implemented by EPA, States and others. That
program has achieved substantial risk reduction through voluntary
public action since the release of the original ``A Citizen's Guide to
Radon'' in 1986 (USEPA 1986, 1992b) and the U.S. Surgeon General's
recommendation in 1988 that all homes be tested and elevated levels be
reduced. The program has been successful in achieving indoor radon risk
reduction through a variety of program strategies, which form the basis
for EPA's proposed multimedia mitigation program plan criteria. Based
on the estimated number of existing homes fixed and the number of new
homes built radon-resistant since the national program began in 1986,
EPA estimates that under existing Federal and State indoor radon
programs, a total of more than 2,500 lives will be saved through indoor
radon risk reduction efforts expected to take place through the year
2000. Every year the rate of lives saved increases as more existing
houses with elevated radon levels are fixed and as more new houses are
built radon-resistant. For the year 2000, EPA estimates that the rate
of radon-related lung cancer deaths that will be avoided from
mitigation of existing homes and from homes built radon-resistant (in
high radon areas) will be about 350 lives saved per year (USEPA 1999i).
The MMM/AMCL approach is intended to provide a more cost-effective
alternative to achieve radon risk reduction, by allowing States (or
community water systems) to address radon in indoor air from the soil
source, while reducing the highest levels of radon in drinking water.
It is EPA's expectation that most States will develop State-wide
multimedia mitigation programs as the most cost-effective approach.
Most of the States currently have indoor radon programs that are
addressing radon risk from soil, and can be used as the foundation for
development of MMM program plans. EPA expects that State indoor radon
programs will implement MMM programs under agreements with the State
drinking water programs. The regulatory expectation of community water
systems serving 10,000 persons or less is that they meet the
alternative maximum contaminant level (AMCL) and be associated with an
approved MMM program plan--either developed by the State and approved
by EPA or developed by the CWS and approved by the State. Tribal CWS
MMM programs, as well as those in States and Territories that do not
have drinking water primacy, will be approved by EPA. The same general
criteria for State MMM program plans would apply to CWSs in developing
local MMM programs in States that do not have such a program, albeit
with a local perspective on such criteria and commensurate with the
unique attributes of small CWSs. EPA expects that MMM program
strategies for CWSs will be less comprehensive than those of State MMM
programs, and will need to reflect the local character of the community
served by the CWS. Strong public participation in the development of
the CWS MMM program plans will help to ensure this, as well as
community support for the MMM program. Figures I.1 and I.2 provide a
conceptual model for the MCL, AMCL, and MMM programs for small and
large systems.
BILLING CODE 6560-50-P
[[Page 59250]]
[GRAPHIC] [TIFF OMITTED] TP02NO99.000
[[Page 59251]]
[GRAPHIC] [TIFF OMITTED] TP02NO99.001
BILLING CODE 6560-50-C
[[Page 59252]]
To meet the requirements of SDWA, the risk reduction benefits
expected to be achieved by MMM programs are to be equal to or greater
than risk reduction benefits that would be achieved by CWSs complying
with the MCL. Under SDWA, this means that if all States implemented MMM
programs they would be expected to result in about 62 cancer deaths
averted annually, equal to what would be achieved with universal
compliance with the MCL at 300 pCi/L. Unlike health risk reduction
benefits gained through water treatment, which remain constant from one
year to the next, the rate of health benefits from reducing indoor
radon is cumulative; that is, it steadily increases every year with
every additional existing home that is mitigated and with every new
home built radon-resistant. Therefore, MMM programs will use and build
on the indoor radon program framework to achieve ``equal or greater''
risk reduction, rather than focusing efforts on precisely quantifying
``equivalency'' to the much more limited risk reduction expected to
occur if community water systems complied with the MCL.
G. What Are the Proposed Limits for Radon in Drinking Water?
The proposed regulation provides that States may adopt State-wide
MMM programs and the alternative maximum contaminant level (AMCL) of
4000 pCi/L. This is the most effective approach for radon risk
reduction and the one EPA expects the majority of States to adopt. If a
State has an EPA-approved MMM program plan, CWSs in that State may
comply with the AMCL. In the absence of an approved State MMM program
plan the regulatory expectation for small CWSs (those serving 10,000 or
fewer) is that they comply with a level of 4000 pCi/L in drinking
water, and develop and implement a State-approved local MMM program
plan to reduce indoor radon risks arising from soil and rock under
homes and buildings. Small CWSs may also choose to comply with the MCL
of 300 pCi/L (and not develop a local MMM program.)
The AMCL/MMM approach is EPA's regulatory expectation for small
CWSs because an MMM program and compliance with the AMCL is a much more
cost-effective way to reduce radon risk than compliance with the
maximum contaminant level (MCL) of 300 pCi/L. (While EPA believes that
the MMM approach is preferable for small systems in a non-MMM State,
small CWSs may, at their discretion, choose the option of meeting the
MCL instead of developing a local MMM program). Large CWSs (serving a
population of more than 10,000) must either comply with the proposed
MCL or comply with the AMCL and implement a State-approved CWS MMM
program plan (in the absence of an approved State MMM program plan).
If a State has an approved MMM program plan, the standard for radon
in drinking water that the State would adopt in order to obtain primacy
would be 4000 pCi/L.
Under the proposed requirements, an MMM program plan must address
four criteria:
1. Public involvement in development of the MMM program plan
2. Quantitative goals for existing homes fixed and new homes built
radon-resistant
3. Strategies for achieving goals
4. Plan to track and report results
CWSs must monitor for radon in drinking water according to the
requirements described in Section VIII of this preamble, and report
their results to the State. If the State determines that the radon
level in a CWS is below 300 pCi/L, the system need only continue to
meet monitoring requirements and is not covered by the requirements
described in Section VI of this preamble, regarding MMM programs.
H. What Is the Proposed Best Available Technology (BAT) for Treating
Radon in Drinking Water?
Proposed BAT for Radon Under Section 1412 of the SDWA
High-performance aeration, as described in Section VIII.A of this
preamble, is the BAT for all systems. For systems serving 10,000
persons or fewer, the BAT is high-performance aeration and the Small
Systems Compliance Technologies, as described in Section VIII.A.
Proposed BAT for Radon Under Section 1415 of the SDWA
BAT for purposes of variances is the same as BAT under Section 1412
of the Act.
I. What Analytical Methods Are Recommended?
EPA is proposing Liquid Scintillation Counting (Standard Method
7500-Rn) and de-emanation (``Lucas Cell'') as the approved methods. The
Liquid Scintillation Counting method designated ``D 5072-92'' by the
American Society for Testing and Materials (ASTM) is being proposed as
an alternate method.
J. Where and How Often Must I Test My Water for Radon?
All CWSs that use ground water must monitor for radon. If your
system relies on ground water or uses ground water to supplement
surface water during low-flow periods, you must monitor for radon. If
you are required to monitor for radon you must collect samples for
analysis at each entry point to the distribution system, after
treatment and storage. Initially all CWSs using ground water must
monitor for radon at each entry point to the distribution system
quarterly for one year. (See Section VII.E for discussion of compliance
dates). If the results of analyses show that the average of all first
year samples at any sample site is above the MCL/AMCL, you must
continue monitoring quarterly at that sampling site until the average
of four consecutive quarterly samples is below the MCL/AMCL. If the
results of analyses show that the average of all first year samples at
each sample site is below the MCL/AMCL, you may reduce monitoring to
once a year at State discretion at each sample site. If the results
indicate that the average of the four quarterly samples are close to
the MCL/AMCL (as discussed next), the State may require you to continue
monitoring quarterly.
The State may allow you to reduce monitoring for radon to a
frequency of once every three-years, if the average from four
consecutive quarterly samples is less than \1/2\ the MCL/AMCL and the
State determines that your system is reliably and consistently below
the MCL/AMCL. However, if a sample collected while monitoring annually
or less frequently exceeds the radon MCL/AMCL, the monitoring frequency
must be increased to quarterly until the average of 4 consecutive
quarterly samples is less than the MCL/AMCL. The State may require the
collection of a confirmation sample(s) to verify the result of the
initial sample. In the case of reduced monitoring, if the analytical
results from any sampling point are found to exceed \1/2\ the MCL/AMCL,
the State may require you to collect a confirmation sample at the same
sampling point. The results of the initial sample and the confirmation
sample(s) will be averaged and the resulting average will be used to
determine compliance. States may, at their discretion, disregard
samples that have obvious sampling errors.
If, after initial monitoring, the State determines that it is
highly unlikely that radon levels in your system will be above the MCL/
AMCL, the State may grant a waiver reducing monitoring frequency to
once every nine years. In granting the waiver, the State must take into
consideration factors such as the geological area of the source water
and previous analytical results which demonstrate that radon levels do
not
[[Page 59253]]
occur above the MCL/AMCL. If you are granted a waiver, it remains in
effect for a nine year period.
If you monitor for radon after proposal of this rule, you may use
the data, at the State's discretion, toward satisfying the initial
sampling requirements for radon. Your monitoring program and the
methods used to analyze for radon must satisfy the regulations set out
in the proposal.
K. May I Use Point-of-Use (POU) Devices, Point-of-Entry (POE) Devices,
or Bottled Water To Comply With This Regulation?
POE aeration or granular activated carbon (GAC) would be allowable
for use to achieve compliance with MCLs. While these POE technologies
are not considered BAT for large systems, they are considered small
system compliance technologies (SSCTs), and thus may serve as BAT under
Sections 1412 and 1415 of the Act for systems serving 10,000 persons or
fewer. Since POU devices are used to treat water at a single tap, radon
will be released at unacceptable levels from the other non-treated
taps, including the shower head. For this reason, POU devices do not
adequately address radon risks and will not be allowed to be used for
compliance purposes. Likewise, although bottled water reduces ingestion
risk from radon, it does not reduce radon-related inhalation risks from
household water. For this reason, compliance determinations based on
bottled water consumption cannot be used.
L. May I Get More Time or Use a Cheaper Treatment? Variances and
Exemptions
Variances and Exemptions (Section 1415.a of the SDWA)
States and Tribes with primary enforcement responsibility
(``primacy'') may issue a variance under Section 1415(a)(1)(A) of the
Act to a CWS that cannot comply with an MCL because of source water
characteristics on condition that the system install the best available
technology. Under Section 1416 of the Act, primacy entities may exempt
a CWS from an NPDWR due to ``compelling factors'', subject to the
restrictions described in the Act. Primacy entities may require systems
to implement additional interim control measures such as installation
of additional centralized treatment or POE devices for each customer as
measures to reduce the health risk before granting a variance or
exemption. The primacy entity must find that the variance or exemption
will not pose an ``unreasonable risk to health'', as determined by the
State or other primacy entity. Guidance for estimating ``unreasonable
risk to health'' (URTH) values for contaminants, including radon, is
being developed by EPA and will result in an upcoming publication (a
draft of the guidance is expected in the Fall of 1999). Preliminary
information regarding URTH values may be found elsewhere (Orme-Zavaleta
1992, USEPA 1998f). States must require CWSs to provide POE devices or
other means, as appropriate to the risks present (i.e., no POU or
bottled water for volatile contaminants, such as radon), to reduce
exposure below unreasonable risk to health values before granting a
variance or exemption.
``Small Systems Variances'' (Section 1415(e) of the SDWA)
For NPDWRs proposed after the 1996 Amendments to the Act, EPA is
required to evaluate the affordability and technical feasibility of
treatment technologies for use as compliance technologies for small
systems. Three categories of small systems will be considered: those
serving: (1) 25-500, (2) 501-3,300, and (3) 3,301-10,000 persons. If
EPA determines that source water conditions exist for one or more small
water system size categories such that typical small systems within a
given category will not be able to afford and/or implement a technology
capable of achieving compliance, then EPA will designate applicable
``small systems variance technologies'' (SSVTs) capable of achieving
contaminant levels that are ``protective of public health''. Primacy
entities may issue small systems variances to eligible CWSs that
install and properly maintain a listed SSVT. For a small system to be
eligible for a small systems variance, the primacy entity must
determine that the system cannot afford to comply through installing
treatment, finding an alternate source of water, or restructuring/
consolidating.
EPA has determined that affordable and technically feasible
technologies exist for radon removal for all classes of small systems.
Under the 1996 SDWA, if EPA lists at least one small systems compliance
technology for a given system size category for all source water
qualities, then it may not list any small systems variance technologies
for that size category, i.e., small systems compliance technologies and
variance technologies are mutually exclusive. For this reason, no small
system will be eligible for a small systems variance for radon under
the SDWA (Section 1415(e)). Small systems may be eligible for general
variances (under Section 1415.a of the Act) and/or exemptions on a case
by case basis. It is also important to emphasize that the presumptive
regulatory expectation for small systems is an MMM program (in the
absence of a State MMM program) and compliance with the AMCL of 4000
pCi/L. Thus, for the vast majority of small systems (those with radon
levels below 4000 pCi/L), compliance with this proposed rule will not
involve any treatment of drinking water.
M. What Are State Primacy, Record Keeping, and Reporting Requirements?
The proposed Radon Rule requires States to adopt several regulatory
requirements, including public notification requirements, MCL/AMCL for
radon, and the requirements of Subpart R in the proposed rule. In
addition, States and eligible Indian tribes will be required to adopt
several special primacy requirements for the Radon Rule. The proposed
rule includes additional reporting requirements for MMM program plans.
The proposed rule also requires States to keep specific records in
accordance with existing regulations. These requirements are discussed
in more detail in Section IX of this preamble.
N. How Are Tribes Treated in This Proposal?
The proposal provides Tribes the option of seeking ``treatment in
the same manner as a State'' for the purposes of assuming enforcement
responsibility for a CWS program, and developing and implementing an
MMM program (see Section VI.C). If a Tribe chooses not to implement an
EPA-approved MMM program, any tribal CWS may develop an MMM plan for
EPA approval, under the same criteria described in Section VI.A.
Statutory Requirements and Regulatory History
II. What Does the Safe Drinking Water Act Require the EPA To Do
When Regulating Radon in Drinking Water?
The 1996 Amendments to the Safe Drinking Water Act (PL 104-182)
establish a new charter for public water systems, States, Tribes, and
EPA to protect the safety of drinking water supplies. (For an overview
of the general requirements for all drinking water regulations, see
Section XVI of this preamble). Among other mandates, Congress amended
Section 1412 of the SDWA to direct EPA to take the following actions
regarding radon in drinking water.
[[Page 59254]]
A. Withdraw the 1991 Proposed Regulation for Radon
Congress specified that EPA should withdraw the drinking water
standards proposed for radon in 1991 (see discussion in Section III.D).
B. Arrange for a National Academy of Sciences Risk Assessment
The amendments in Section 1412(b)(13)(B) require EPA to arrange for
the National Academy of Sciences (NAS) to conduct an independent risk
assessment for radon in drinking water and an assessment of the health
risk reduction benefits from various mitigation measures to reduce
radon in indoor air.
C. Set an MCLG, MCL, and BAT for Radon-222
Congress specified in Section 1412 (b)(13) that EPA should propose
a new MCLG and NPDWR for radon-222 by August, 1999. EPA is also
required to finalize the regulation by August, 2000. As a preliminary
step, EPA was required to publish a radon health risk reduction and
cost analysis (HRRCA) for possible radon MCLs for public comment by
February, 1999. As required by SDWA, this analysis addressed: (1)
Health risk reduction benefits that come directly from controlling
radon; (2) health risk reduction benefits likely to come from
reductions in contaminants that occur with radon; (3) costs; (4)
incremental costs and benefits associated with each MCL considered; (5)
effects on the general population and on groups within the general
population likely to be at greater risk; (6) any increased health risk
that may occur as the result of compliance; and (7) other relevant
factors, including the quality and extent of the information, the
uncertainties in the analysis, and factors with respect to the degree
and nature of the risk.
D. Set an Alternative MCL (AMCL) and Develop Multimedia Mitigation
(MMM) Program Plan Criteria
The amendments in Section 1412(b)(13)(F) introduced two new
elements into the radon in drinking water rule: (1) An Alternative
Maximum Contaminant Level (AMCL), and (2) radon multimedia mitigation
(MMM) programs. If the MCL established for radon in drinking water is
more stringent than necessary to reduce the contribution to radon in
indoor air from drinking water to a concentration that is equivalent to
the national average concentration of radon in outdoor air, EPA is
required to simultaneously establish an AMCL. The AMCL would be the
standard that would result in a contribution of radon from drinking
water to radon levels in indoor air equivalent to the national average
concentration of radon in outdoor air. If an AMCL is established, EPA
is to publish criteria for State multimedia mitigation (MMM) programs
to reduce radon levels in indoor air. Section VI of this preamble
describes what a State or public water system must have in their
multimedia mitigation program plan.
E. Evaluate Multimedia Mitigation Programs Every Five Years
Once the MMM programs are established, EPA must re-evaluate them no
less than every five years (Section 1412(b)(13)(G)). EPA may withdraw
approval of programs that are not expected to continue to meet the
requirement of achieving equal or greater risk reduction.
III. What Actions Has EPA Taken on Radon in Drinking Water Prior to
This Proposal?
A. Regulatory Actions Prior to 1991
Section 1412 of the SDWA, as amended in 1986, required the EPA to
publish Maximum Contaminant Level Goals (MCLGs) and to promulgate
NPDWRs for contaminants that may cause an adverse effect on human
health and that are known or anticipated to occur in public water
supplies. On September 30, 1986, EPA published an advance notice of
proposed rulemaking (ANPRM) (51 FR 34836) concerning radon-222 and
other radionuclides. The ANPRM discussed EPA's understanding of the
occurrence, health effects, and risks from these radionuclides, as well
as the available analytical methods and treatment technologies, and
sought additional data and public comment on EPA's planned regulation.
EPA's Science Advisory Board (SAB) reviewed the ANPRM and the four
draft criteria documents that supported it prior to publication of the
ANPRM in the Federal Register. EPA subsequently revised the criteria
documents and resubmitted them to the SAB for review during the summer
of 1990. EPA then revised the criteria documents based on this
additional round of SAB review and presented a summary of the SAB
comments and the Agency's responses in a 1991 Notice of Proposed
Rulemaking (NPRM).
B. The 1991 NPRM
On July 18, 1991 (56 FR 33050), EPA proposed a NPDWR for radon and
the other radionuclides addressed in the 1986 ANPRM. The 1991 notice,
which built on and updated the information assembled for the 1986
ANPRM, proposed an MCLG, an MCL, BAT, and monitoring, reporting, and
public notification requirements for radon in public water supplies.
The proposed MCLG was zero, the proposed MCL was 300 pCi/L, and the
proposed BAT was aeration. Under the proposed rule, all CWSs and
NTNCWSs relying on ground water would have been required to monitor
radon levels quarterly at each point of entry to the distribution
system. Compliance monitoring requirements were based on the arithmetic
average of four quarterly samples. The 1991 proposed rule required
systems with one or more points of entry out of compliance to treat
influent water to reduce radon levels below the MCL or to secure water
from another source below the MCL.
The proposed rule was accompanied by an assessment of regulatory
costs and economic impacts, as well as an assessment of the risk
reduction associated with implementation of the MCL. EPA estimated the
following potential impacts from the 1991 proposed MCL:
An estimated lifetime cancer risk of about two cancers for
every 10,000 persons exposed to radon in drinking water.
Avoidance of about 80 cancer cases per year.
About 27,000 public water systems affected.
A total annual cost of about $180 million.
The Agency received substantial comments on the proposal and its
supporting analyses from States, water utilities, and other stakeholder
groups. EPA has included in Appendix I of this preamble a summary of
major public comments on the 1991 NPRM and how EPA subsequently
addressed those comments.
C. 1994 Report to Congress: Multimedia Risk and Cost Assessment of
Radon
In 1992, Congress directed EPA to report on the multimedia risks
from exposure to radon, the costs to control this exposure, and the
risks from treating to remove radon. EPA's 1994 Report to Congress
(USEPA 1994a) estimates the risk, fatal cancer cases, cancer cases
avoided and costs for mitigating radon in water and in indoor air. The
Report found that cancer risks from radon in both air and water are
high. While radon risk in air typically far exceeds that in water, the
cancer risk from radon in water is higher than the cancer risk
estimated to result from any other currently regulated drinking water
contaminant.
EPA conducted a quantitative uncertainty analysis of the risks
associated with exposure to radon in
[[Page 59255]]
drinking water. This analysis, reviewed by EPA's SAB at the direction
of Congress, found that:
People are exposed to waterborne radon in three ways: (1)
From ingesting radon dissolved in water; (2) from inhaling radon gas
released from water during household use; and (3) from inhaling radon
progeny derived from radon released from water.
The estimated total U.S. cancer fatalities per year from
unregulated waterborne radon via all three routes of exposure were 192,
with a range from about 51 to 620.
The estimated annual cost was $272 million.
The 1994 Report to Congress noted that the regulated industry
estimated considerably higher costs than EPA for a 300 pCi/L MCL. For
example, in October 1991 the American Water Works Association (AWWA)
estimated national costs at $2.5 billion/year (for discussion of this
issue, see Section G of the Appendix to this preamble). The final part
of the report included the SAB's comments on each analysis presented
and an EPA discussion of the issues raised by the SAB.
D. 1997 Withdrawal of the 1991 NPRM for Radon-222
As required by the SDWA as amended, EPA withdrew the MCLG, MCL, and
monitoring, reporting, and public notification requirements proposed in
1991 for radon-222 on August 6, 1997 (62 FR 42221). No other provision
of the 1991 proposal was affected by this withdrawal.
E. 1998 SBREFA Small Business Advocacy Review Panel for Radon
In 1998, EPA convened a Small Business Advocacy Review Panel to
address the radon rule, in accordance with the Regulatory Flexibility
Act (RFA) as amended by the Small Business Regulatory Enforcement
Fairness Act (SBREFA). The Panel of representatives from EPA, the
Office of Management and Budget's Office of Information and Regulatory
Affairs, and the Small Business Administration's Office of Advocacy
reviewed technical background information related to this rulemaking,
and reviewed comments provided by small business and government
entities affected by this rule. The Panel made recommendations in a
final report to the Administrator which included a discussion of how
the Agency could accomplish its environmental goals while minimizing
impacts to small entities. For additional details, see Section XIV.B of
this proposal.
F. 1999 HRRCA for Radon in Drinking Water
EPA published the Health Risk Reduction and Cost Analysis required
by the SDWA on February 26, 1999 (64 FR 9559), and took public comment
for 45 days. EPA held a one-day public meeting in Washington, D.C. on
March 16, 1999, to present the HRRCA and the latest MMM framework, and
discuss stakeholder questions and issues. For details of the contents
of the HRRCA and EPA's response to significant public comment, see
Section XIII of this preamble.
Requirements
IV. To Which Water Systems Does This Regulation Apply?
The SDWA directs EPA to develop national primary drinking water
regulations (NPDWRs) that apply to public water systems (PWSs). The
statute defines a PWS as a system that provides water to the public for
human consumption if such system has at least 15 service connections or
regularly serves at least 25 individuals (Section 1401(4)(A)). EPA's
regulations at 40 CFR 141.2 define different types of PWSs. A community
water system (CWS) serves at least 15 service connections used by year
round residents or regularly serves at least 25 year-round residents. A
non-community system does not serve year-round residents; rather, it
(1) regularly serves at least 25 of the same persons over 6 months of
the year (a ``non-transient'' system such as a restaurant or church) or
(2) does not serve at least 25 of the same persons over 6 months of the
year (a ``transient'' system such as a campground or service station).
The regulation for radon in drinking water and the multimedia
approach for reduction of radon in indoor air (MMM program) proposed in
this notice applies only to CWSs that use ground water or mixed ground
and surface water (see following discussion regarding ``mixed''
supplies). The proposed regulation does not apply to transient water
systems because most people who use such facilities do so only
occasionally (e.g., travelers). There is no evidence that such short-
term exposure to radon would cause acute illness. The data on which
health risks from radon were determined for this rulemaking reflect
long-term exposure (see chapter 3 of the RIA (USEPA 1999f) HRRCA
section that discusses calculation of risk). And, as discussed next in
the context of non-transient non-community systems, even workers at
transient facilities who regularly drink the water would be expected to
have much less exposure than persons served by community water systems.
For these reasons, the proposed rule does not cover transient systems.
The proposed regulation also does not apply to non-transient non-
community (NTNC) water systems. EPA has determined that the risks posed
to persons served by NTNC systems (such as factories, hospitals, and
schools with their own drinking water wells) are substantially less
than the risks to persons served by community water systems.
The Agency recently completed a preliminary analysis of radon
occurrence (using data provided by six States), exposure and risk at
NTNC public water systems. Results from this preliminary analysis
indicate that even though radon concentrations are likely to be about
60 percent higher at NTNC locations than at locations served by a
community water system, the lifetime average risk to individuals who
work or attend school in buildings served by a groundwater-based NTNC
system is probably about 17 percent of the average risk to a worker
(and 6.7 percent of the average risk to a student) exposed in a home
served by a community ground water system. The reason that risks are
lower in the NTNC setting than the residential setting is that people
who are exposed at NTNC locations spend a smaller fraction of their
lifetime there than in the home. Further, in the particular case of
students most do not spend their entire school years in the same
school. EPA also notes that there is limited data in this area, and
more information is needed on how water is used in NTNC facilities and
on the contribution NTNC water use makes to radon inhalation risk. In
addition, the overall population served by NTNC PWSs is relatively
small (5.2 million vs. 89.7 million in homes served by CWSs using
ground water (USEPA 1999b)).
EPA acknowledges that the SDWA applies to all public water systems.
However, EPA believes that limiting the applicability of the radon rule
to community water systems where the risk from radon exposure is the
greatest meets a major goal of Congress in enacting the 1996 amendments
to the Act-to focus regulations on the most significant problems. In
the Conference Report adopting the 1996 amendments, Congress finds that
``more effective protection of public health requires--a Federal
commitment to set priorities that will allow scarce Federal, State, and
local resources to be targeted toward the drinking water problems of
greatest public health concerns. `` H. Rep. 104-182, Sec. 3. Moreover,
Congress specifically directed EPA in setting the NPDWRs for radon to
take into
[[Page 59256]]
consideration the costs and benefits of control programs for radon from
other sources. EPA has used this authority in this proposal to set the
MCL at 300 pCi/L and to encourage small systems to implement the MMM
program and comply with the AMCL. In both circumstances, EPA took into
account the fact that programs to control radon in indoor air promise
greater benefits at considerably less cost. EPA believes this cost-
effectiveness factor is also relevant in determining the applicability
of the radon rule. EPA's preliminary analysis of the risk associated
with exposure to radon from NTNC systems is that it is much less than
the risk from exposure from CWSs. For this reason, EPA has determined
that it is not cost-effective to regulate these systems.
However, it is important to note that this analysis is based on
limited occurrence and exposure data. In particular, relatively little
is known about the transfer factor for release of radon from water into
indoor air at NTNC locations, or about the equilibrium factor affecting
the amount of radon in indoor air at such locations. The calculations
done by EPA to date have assumed that certain values for these
parameters at NTNC locations are similar to those in homes, although
the data are limited.
The EPA is soliciting comment on the proposal to exclude NTNC PWSs
from the radon regulation. EPA is soliciting comments on the Agency's
preliminary analysis of radon exposure in NTNC PWSs, as well as any
additional data on key parameters, including data on the release of
radon from drinking water in the types of buildings (e.g., restaurants,
factories, churches, etc.) supplied by NTNC PWSs, and occurrence of
radon in NTNC PWSs. If information by commenters shows a greater
opportunity for risk reduction than identified in its initial analysis,
EPA may make the final radon rule applicable to NTNC PWSs without
further public comment.
With regard to systems using mixed ground and surface water,
current regulations require that all systems that use any amount of
surface water as a source be categorized as surface water systems. This
classification applies even if the majority of water in a system is
from a ground water source. Data currently in SDWIS does not identify
how many of these mixed systems exist although this information would
help the Agency to better understand regulatory impacts. To the extent
that systems correctly classified by SDWIS as surface water systems
also use ground water that may exceed the MCL/AMCL for radon, the costs
and benefits of the current proposal will be underestimated.
EPA is investigating ways to identify how many mixed systems exist
and how many mix their ground and surface water at the same entry point
or at separate entry points within the same distribution systems. For
example, a system may have several plants/entry points that feed the
same distribution system. One of these entry points may mix and treat
surface water with ground water prior to its entry into the
distribution system. Another entry point might use ground water
exclusively for its source while a different entry point would
exclusively use surface water. However, all three entry points would
supply the same system classified in SDWIS as surface water.
One method EPA could use to address this issue would be to analyze
Community Water System Survey (CWSS) data then extrapolate this
information to SDWIS to obtain a national estimate of mixed systems.
CWSS data, from approximately 1,900 systems, breaks down sources of
supply at the level of the entry point to the distribution system and
further subdivides flow by source type. The Agency could use the
national estimate of mixed systems to regroup surface water systems for
certain impact analyses when regulations only impact one type of
source. The Agency requests comment on this methodology and its
applicability for use in regulatory impact analyses.
V. What Is the Proposed Maximum Contaminant Level Goal for Radon?
A. Approach To Setting the Maximum Contaminant Level Goal (MCLG)
Under Section 1412(b)(4) of the SDWA, the EPA must establish
maximum contaminant level goals (MCLG) at the level at which no known
or anticipated adverse effects on the health of persons occur, and
which allow an adequate safety margin. Section 1412(b)(13) requires the
Administrator to set an MCLG for radon in drinking water.
B. MCLG for Radon in Drinking Water
As described in Section XII of this preamble, radon is a documented
human carcinogen, classified by EPA as a Group A carcinogen (i.e.,
there is sufficient evidence of a causal relationship between exposure
to radon and lung cancer in humans). Radon is classified as a known
human carcinogen based on data from epidemiological studies of
underground miners. This finding is supported by a consensus of opinion
among national and international health organizations. The
carcinogenicity of radon has been well established by the scientific
community, including the Biological Effects of Ionizing Radiation (BEIR
VI) Committee of the National Academy of Sciences (NAS 1999a), the
National Institute of Environmental Health Sciences, U.S. Department of
Health and Human Services, the World Health Organization's
International Agency for Research on Cancer (IARC 1988), the
International Commission on Radiological Protection (ICRP 1987), and
the National Council on Radiation Protection and Measurement (NCRP
1984). In addition, the Centers for Disease Control, the American Lung
Association, the American Medical Association, the American Public
Health Association and others have recognized radon as a significant
public health problem.
Based on the well-established human carcinogenicity of radon, and
of ionizing radiation in general, the Agency is proposing an MCLG of
zero for radon in drinking water. This decision is also supported by
the NAS' current recommendation for a linear non-threshold relationship
between exposure to radon and cancer in humans. In the BEIR VI report
(NAS 1999a), the NAS concluded that there is good evidence that a
single alpha particle (high-linear energy transfer radiation) can cause
major genomic changes in a cell, including mutation and transformation
that potentially could lead to cancer. They noted that even if
substantial repair of the genomic damage were to occur, ``the passage
of a single alpha particle has the potential to cause irreparable
damage in cells that are not killed.'' Given the convincing evidence
that most cancers originate from damage to a single cell, the committee
went on to conclude that ``On the basis of these [molecular and
cellular] mechanistic considerations, and in the absence of credible
evidence to the contrary, the committee adopted a linear non-threshold
model for the relationship between radon exposure and lung-cancer risk.
However, the BEIR VI committee recognized that it could not exclude the
possibility of a threshold relationship between exposure and lung
cancer risk at very low levels of radon exposure.'' The NAS committee
on radon in drinking water (NAS 1999b) reiterated the finding of the
BEIR VI committee's comprehensive review of the issue, that a
``mechanistic interpretation is consistent with linear non-threshold
relationship between radon exposure and cancer risk''. The committee
noted that the ``quantitative
[[Page 59257]]
estimation of cancer risk requires assumptions about the probability of
an exposed cell becoming transformed and the latent period before
malignant transformation is complete. When these values are known for
singly hit cells, the results might lead to reconsideration of the
linear no-threshold assumption used at present.'' EPA recognizes that
research in this area is on-going but is basing its regulatory
decisions on the best currently available science and recommendations
of the NAS that support use of a linear non-threshold relationship. For
additional information on this issue see Section XII.C.3. ``Biologic
Basis of Risk Estimation'' of this preamble.
VI. What Must a State or Community Water System Have in Its
Multimedia Mitigation Program Plan?
Today's proposed rule provides States (as defined in Section 1401
of the SDWA) with alternatives for controlling radon exposure. States
can develop a MMM program for the reduction of the higher risk of radon
in indoor air together with an alternative MCL (AMCL) of 4000 pCi/L to
address the highest levels of exposure from radon in drinking water. If
a State does not choose this option, the community water systems (CWS)
in that State must develop and implement local MMM program plans or
comply with an MCL of 300 pCi/L. See Section VII for information on the
regulatory expectations for CWSs.
A. What Are the Criteria?
1. Overview
EPA has identified four criteria that State MMM program plans are
required to meet to be approved by EPA. MMM program plans developed by
Indian tribes will be reviewed by EPA, according to these same
criteria. CWSs developing local MMM programs are also subject to these
criteria. These four criteria are: public participation, setting
quantitative goals, strategies for achieving goals, and a plan to track
and report results.
The criteria are based on a number of factors. Foremost, the
criteria reflect the elements found in successful voluntary action
programs for radon in indoor air that have been underway for more than
a decade. It is estimated that at the end of the year 2000, voluntary
programs to test homes and mitigate elevated radon levels in indoor air
and to encourage the construction of ``radon-resistant'' new homes will
have saved some 2500 lives; and, there is much more that can be done.
In the 1999 BEIR VI report (NAS 1999a), NAS concluded that 5,000 to
7,000 cancer cases (using two different methods) could be avoided
annually if all homes were below EPA's voluntary radon action level of
4 pCi/L of air. Incorporating these program elements into the criteria
required for the MMM programs builds on successful efforts and can be
expected to result in an even greater number of lives saved as more
States adopt programs and existing programs are strengthened and
expanded.
EPA has developed criteria that allow considerable flexibility for
those developing and expanding programs. EPA was urged by States and
other stakeholders to avoid prescribing the specific elements of the
MMM program in a ``one size fits all'' approach. States and CWSs
adopting MMM programs will be required to set quantitative goals for
mitigating elevated levels of radon in indoor air of existing homes and
building radon-resistant new homes, and to initiate strategies to
promote and increase these activities. However, there are requirements
that will be new to many of the State indoor radon programs. Those
adopting MMM programs will be required to involve the public in a
number of important (and on-going) ways, and to track and report
results from the implementation of the programs. With these additional
elements, both the affected public and EPA will be able to assess the
success of the MMM programs. Stakeholder input and EPA's experience
with the national voluntary program and the State indoor radon programs
led EPA to conclude that these criteria will provide the basis for a
program that meets the statutory directive for equal or greater risk
reduction benefits.
The Agency also considered equity-related issues concerning the
potential impacts of MMM program implementation. There is no factual
basis to indicate that minority and low income or other communities are
more or less exposed to radon in drinking water than the general
public. However, some stakeholders expressed more general concerns
about equity in radon risk reduction that could arise from the MMM/AMCL
framework outlined in SDWA. One concern is the potential for an uneven
distribution of risk reduction benefits across water systems and
society. Under the proposed framework for the rule, customers of CWSs
complying with the AMCL could be exposed to a higher level of radon in
drinking water than if the MCL were implemented, though this level
would not be higher than the background concentration of radon in
ambient air. However, these CWS customers could also save the cost,
through lower water rates, of installing treatment technology to comply
with the MCL. Under the proposed regulation, CWSs and their customers
have the option of complying with either the AMCL (associated with a
State or local MMM program) or the MCL. EPA believes it is important
that these issues and choices be considered in an open public process
as part of the development of MMM program plans. Therefore, EPA has
incorporated requirements into the proposed rule that provide a
framework for consideration of equity concerns with the MMM/AMCL.
First, the proposed rule includes requirements for public participation
in the development of MMM program plans, as well as for notice and
opportunity for public comment. EPA believes that the requirement for
public participation will result in State and CWS program plans that
reflect and meet their different constituents' needs and concerns and
that equity issues can be most effectively dealt with at the State and
local levels with the participation of the public. In developing their
MMM program plans, States and CWSs are required to document and
consider all significant issues and concerns raised by the public. EPA
expects and strongly recommends that States and CWSs pay particular
attention to addressing any equity concerns that may be raised during
the public participation process. In addition, EPA believes that
providing CWS customers with information about the health risks of
radon and on the AMCL and MMM program option will help to promote
understanding of the health risks of radon in indoor air, as well as in
drinking water, and help the public to make informed choices. To this
end, EPA is requiring CWSs to alert consumers to the MMM approach in
their State in consumer confidence reports issued between publication
of the final radon rule and the compliance dates for implementation of
MMM programs. This will include information about radon in indoor air
and drinking water and where consumers can get additional information.
EPA is encouraging the States to elect to develop and implement
State-wide MMM program plans. Since almost all States currently have
State indoor radon programs, EPA considers the States to be best
positioned to develop strong MMM program plans that, when implemented,
will be expected to achieve equal or greater radon risk reduction when
compared to compliance with the MCL. For example, a State-wide plan can
take into account the within-State variations in indoor radon
potential, the differences in radon
[[Page 59258]]
levels in drinking water, the experienced coalitions and cooperative
partners that have been working to promote public action on indoor
radon, the technical expertise of State drinking water and indoor radon
programs, and many other factors. EPA expects that the States will be
best positioned to develop MMM program plans that are robust and
credible in terms of the level of public participation in the
development and review process, the goals that are to be achieved from
implementation of MMM, and the program strategies to be used.
In the development of State MMM program plans meeting EPA's
criteria and in the implementation of the State's MMM program plan, EPA
expects and strongly recommends that the State's programs responsible
for drinking water and for indoor radon coordinate and collaborate on
their efforts. This is particularly important because of the uniqueness
of the MMM/AMCL approach which addresses radon risk reduction in
drinking water and in indoor air in a multimedia manner that is outside
the normal regulatory structure for drinking water. Both programs have
important responsibilities and roles in making the AMCL and MMM program
approach successful in achieving optimal radon risk reduction. To this
end, EPA has included as a special primacy requirement (see Section
142.16 of the proposed rule) that States include in their primacy
revision application for the AMCL a description of the extent and
nature of coordination between the State's interagency programs (i.e.,
indoor radon and drinking water programs) on development and
implementation of the MMM program plan, including the level of
resources that will be made available for implementation and
coordination between these agencies.
CWSs developing local MMM program plans are also subject to these
criteria. CWS MMM program plans developed in the absence of a State
program are deemed to be approved by EPA if they meet the same criteria
and are approved by the State. States without a MMM program, as a
special condition of primacy (see Section 142.16 of the proposed rule),
will be required to review and approve local CWS MMM program plans and
to submit their process for approving such plans to EPA. The Agency
considered an approach under which it would directly review and approve
CWS MMM program plans. However, for several reasons, EPA is proposing
that States review local MMM program plans. EPA believes that
responsibility for such reviews is an appropriate and natural extension
of the States' primacy responsibilities for oversight and enforcement
of drinking water regulations. State review and approval of local MMM
program plans will ensure that all elements of the radon rulemaking--
both the MMM program as well as implementation of the AMCL/MCL--are
enforced through the State, rather than separating elements of the rule
between the Federal and State governments. Dividing responsibility in
such a way may complicate implementation of both elements of the radon
rule and be confusing to both CWSs and the public. EPA also believes
that the States are best positioned to assist CWSs, especially small
systems, in the development of local MMM programs plans to review and
approve local plans that meet the four criteria. States have a direct
and ongoing regulatory relationship with CWSs as a part of their
primacy authorities, as well as a major responsibility for public
health related policy and programs in the State. In addition, States
are aware of and sensitive to local public health needs and concerns,
as well as other issues, that may need to be considered in the
development and implementation of local MMM programs. For all these
reasons, EPA is proposing an approach today that would require the
States to review and approve local MMM program plans in accordance with
the same criteria used in EPA's review of State MMM program plans.
However, EPA solicits comments on other approaches, such as EPA review
and approval of local MMM program plans or other options intermediate
between sole State or sole Federal responsibility.
EPA anticipates, and recommends, that States would assist CWSs in
developing their local MMM program plans and would approve program
plans that meet the criteria and that reflect local radon
implementation issues as discussed in Section VI.F. In non-MMM States,
EPA is also including as a special primacy requirement that States
include in their primacy revision application for the MCL a description
of the extent and nature of coordination between interagency programs
(i.e., indoor radon and drinking water programs) on development and
implementation of the State's review and approval process for CWS MMM
program plans, including the level of resources will be made available
for implementation and coordination between these agencies.
2. Criteria for MMM Program Plans
The following four criteria are required for approval of State MMM
program plans by EPA. Local MMM program plans developed by community
water systems are deemed to be approved by EPA if they meet these
criteria (as appropriate for the local level) and are approved by the
State. The term ``State'', as referenced next, includes States, Indian
tribes and community water systems. EPA is requesting comment on each
of the criteria for approval of State, and CWS, MMM program plans. In
particular, EPA is requesting comment on whether the criteria need to
be more or less stringent, and the supporting rationale for EPA's
consideration of other potentially credible approaches.
(a) Description of Process for Involving the Public. (1) States are
required to involve community water system customers, and other sectors
of the public with an interest in radon, both in drinking water and in
indoor air, in developing their MMM program plan. The MMM program plan
must include:
A description of processes the State used to provide for public
participation in the development of its MMM program plan, including the
components identified in the following paragraphs b, c, and d;
A description of the nature and extent of public participation that
occurred, including a list of groups and organizations that
participated;
A summary describing the recommendations, issues, and concerns arising
from the public participation process and how these were considered in
developing the State's MMM program plan; and,
A description of how the State made information available to the public
to support informed public participation, including information on the
State's existing indoor radon program activities and radon risk
reductions achieved, and on options considered for the MMM program plan
along with any analyses supporting the development of such options.
(2) Once the draft program plan has been developed, the State must
provide notice and opportunity for public comment on the draft plan
prior to submitting it to EPA.
(b) Quantitative Goals. (1) States are required to establish and
include in their plans quantitative goals, to measure the effectiveness
of their MMM program, for the following:
(i) Existing houses with elevated indoor radon levels that will be
mitigated by the public; and,
(ii) New houses that will be built radon-resistant by home
builders.
EPA is proposing to require establishing quantitative goals in
these
[[Page 59259]]
two areas because they represent the most direct link to the risk
reduction benefits that are the ultimate objective of the MMM programs.
In addition, EPA analyses indicate that it is very cost-effective to
test and mitigate existing homes with elevated indoor radon levels. It
is also very cost-effective to build new homes radon-resistant,
especially in higher radon potential areas. In the existing indoor
radon program, EPA has been encouraging the States to promote testing
and mitigation in all areas of a State. EPA has also encouraged the
States to focus on their activities to promote radon-resistant new
construction on the highest radon potential areas (Zone 1) where
building homes radon-resistant is most cost-effective. However, it is
also cost-effective to build homes in medium potential areas (Zone 2),
as well as in ``hot'' spots found in most lower radon potential areas
(Zone 3).
EPA recognizes the States' (and CWSs') need for flexibility in
designing MMM programs reflecting their needs and circumstances, in
particular the extent to which opportunities are available for risk
reduction in mitigation of existing homes with elevated indoor radon
levels or in construction of new homes built radon-resistant. Some
States, in particular those with a preponderance of lower radon
potential areas (and for CWSs in lower radon potential areas), may find
it preferable to focus more heavily on testing and mitigation of
existing housing than on radon-resistant new construction.
EPA is requesting comment on whether there are alternative goals
that achieve radon risk reduction and the rationale for those goals.
EPA is also soliciting comments on the goals outlined in paragraph (b),
in particular on the appropriateness of the goals and whether the goals
need to be more or less stringent.
(2) These goals must be defined quantitatively either as absolute
numbers or as rates. If goals are defined as rates, a detailed
explanation of the basis for determining the rates must be included.
EPA is proposing to provide this option, in part, because
opportunities available for risk reduction in mitigation of existing
homes with elevated indoor radon levels or in construction of new homes
built radon-resistant may vary between States and within States. In
addition, the level of new home construction may vary from year to year
in different parts of a State or in a local jurisdiction. In this
situation, it may be more appropriate to set goals for radon-resistant
new construction as a rate, rather than absolute numbers, to account
for this variability. This may be especially true for CWS developing
local MMM program plans where no new home construction is currently
taking place but may in the future.
(3) States are required to establish goals for promoting public
awareness of radon health risks, for testing of existing homes by the
public, for testing and mitigation of existing schools, and for
construction of new public schools to be radon-resistant, or to include
an explanation of why goals were not established in these program
areas.
EPA is proposing that States have this option of defining goals as
absolute numbers or as rates because, while awareness of radon health
risks is a necessary element and a first step in getting the public to
take action on indoor radon, public awareness, in and of itself, does
not constitute radon exposure reduction. It does, however, help to
facilitate informed choice by the public regarding radon testing and
mitigation. Since the level of awareness on the health effects of radon
is already high in many States, EPA is proposing to give flexibility to
the States on this goal. In the case of radon in schools, many States
have undertaken a range of activities to address radon in schools and
some have done extensive testing, in some cases passing State
legislation requiring the State to test public schools. Therefore, EPA
is proposing to give States the option of setting these goals for
schools. Although this approach provides flexibility in goal setting,
EPA strongly encourages those States which do not have high levels of
public awareness on radon and where there has been limited testing of
public schools across the State to set goals in these areas. EPA is
soliciting comment on whether States should be required to set
quantitative goals in all or some of these areas in paragraph (b)(3).
(c) Implementation Plans. (1) States are required to include in
their MMM program plan implementation plans outlining the strategic
approaches and specific activities the State will undertake to achieve
the quantitative goals identified in paragraphs (b)(1) and (b)(2). This
must include implementation plans in the following two key areas:
(i) Promoting increased testing and mitigation of existing housing
by the public through public outreach and education and during
residential real estate transactions.
(ii) Promoting increased use of radon-resistant techniques in the
construction of new homes.
(2) If a State has included goals for promoting public awareness of
radon health risks; promoting testing of existing homes by the public;
promoting testing and mitigation of existing schools; and promoting
construction of new public schools to be radon resistant, then the
State is required to submit a description of the strategic approach
that will be used to achieve the goals.
(3) States are required to provide the overall rationale and
support for why their proposed quantitative goals identified in
paragraphs (b)(1) and (b)(2), in conjunction with their program
implementation plans, will satisfy the statutory requirement that an
MMM program be expected to achieve equal or greater risk reduction
benefits to what would have been expected if all public water systems
in the State complied with the MCL.
(d) Plans for Measuring and Reporting Results. (1) States are
required to include in the MMM plan submitted to EPA a description of
the approach that will be used to assess the results from
implementation of the State MMM program, and to assess progress towards
the quantitative goals in paragraphs (b)(1) and (b)(2). This
specifically includes a description of the methodologies the State will
use to determine or track the number of existing homes with elevated
levels of radon in indoor air that are mitigated and the number or the
rate of new homes built radon-resistant. This must also include a
description of the approaches, methods, or processes the State will use
to make the results of these assessment available to the public.
(2) If a State includes goals in paragraph (b)(3) for promoting
public awareness of radon health risks; testing of existing homes by
the public; testing and mitigation of existing schools; and,
construction of new public schools to be radon-resistant; the State is
required to submit a description of how the State will determine or
track progress in achieving each of these goals. This must also include
a description of the approaches, methods, or processes the State will
use to make these results available to the public.
B. Why Will MMM Programs Get Risk Reduction Equal or Greater Than
Compliance With the MCL?
The National Indoor Radon Program implemented by EPA, States and
others, has achieved substantial risk reduction through voluntary
public action since the release of the original ``A Citizen's Guide to
Radon'' in 1986 (USEPA 1986) (updated: USEPA 1992b) and the U.S.
Surgeon General's recommendation in 1988 (US EPA, 1988b) that all homes
be tested and elevated radon levels be reduced. The program has been
[[Page 59260]]
successful in achieving voluntary risk reduction on indoor radon
through a variety of program strategies. It is important to keep in
perspective the comparatively large potential for risk reduction that
can be achieved if all existing homes with indoor radon levels at or
above EPA's voluntary action level for indoor radon of 4 pCi/L in the
U.S. were mitigated (approximately 6 million homes). In addition there
is the potential for significant risk reduction potential if the
approximately 1 million new homes built annually in the U.S. were built
radon-resistant. Based on the estimated number of existing homes fixed
and the number of new homes built radon-resistant since the national
program began in 1986, EPA estimates that a total of more than 2,500
lives will be saved through voluntary indoor radon risk reduction
efforts expected to take place up through the year 2000. Every year the
rate of lives saved increases as more existing houses with elevated
radon levels are fixed and as more new houses are built radon-
resistant. On average this rate of lives that will be saved from these
risk reduction actions increases by about 30 additional lives per year.
EPA estimates that for the year 2000, the rate of radon-related lung
cancer deaths that will be avoided from mitigation of existing homes
and from homes built radon-resistant in high radon areas will be about
350 lives saved per year (USEPA 1999i).
Under the radon provision of SDWA, if all States adopted the AMCL,
all State MMM programs together must be expected to result in at
minimum about 62 cancer deaths averted annually; equal to what would be
achieved with universal compliance with the MCL. Unlike these health
risk reduction benefits which remain constant from one year to the
next, the rate of health benefits from reducing radon in indoor air, as
noted previously, steadily increases every year with every additional
existing home that is mitigated and with every new home built radon-
resistant. This steady incremental risk reduction offered by mitigation
of existing homes with elevated indoor radon and building homes radon-
resistant, especially during real estate transactions and through
builder and consumer education and State and local adoption of radon-
resistant building codes, holds the potential for substantial long-term
risk reduction. NAS in their 1999 BEIR VI Report, concluded that up to
one third (i.e., 5,000 to 7,000) of their estimated 15,000 to 22,000
annual radon-related lung cancer deaths in the U.S. could be avoided if
all homes were below EPA's voluntary radon action level of 4 pCi/L of
air (NAS 1999a). This does not include the risk reduction that is
achieved from new homes built radon-resistant. The one million new
homes on average being built every year represent a significant radon
risk reduction opportunity. Therefore, a critical element for MMM is to
utilize and build on the indoor radon program framework to achieve
``equal or greater'' risk reduction rather than focusing efforts on
precisely quantifying the much more limited risk reduction that will
not occur in community water systems complying with the AMCL (i.e., the
difference in the risk reduction between the MCL and the AMCL).
C. Implementation of an MMM Program in Non-Primacy States
A State that does not have primary enforcement responsibility for
the Public Water System Program under Section 1413 of the SDWA
(``primacy'') and where EPA administers the CWS program may still
develop a State-wide MMM program plan. EPA would not expect to develop
an MMM program plan where the State elects not to develop a State-wide
MMM program plan. Accordingly, CWSs in such jurisdictions would be
required to comply with the more stringent MCL or develop local MMM
program plans for approval by EPA.
The SDWA authorizes all States to develop and submit a MMM program
plan to mitigate radon levels in indoor air for approval by the
Administrator under Section 1412(b)(13)(G). EPA is proposing that
States that do not have primacy may submit a plan to EPA that meets the
criteria of 40 CFR 141.302. If the State's plan is approved, the State
would be subject to all reporting and compliance requirements of 40 CFR
141.303. Community water systems in States with approved MMM programs
would comply with the AMCL of 4000 pCi/L, and would be subject to the
requirements for monitoring and analytical methods in 40 CFR 141.20.
EPA would continue to administer compliance with the MCL/AMCL, and with
monitoring and methods requirements.
D. Implementation of the MMM Program in Indian Country
Under this proposal, States can develop State-wide MMM programs for
the reduction of radon in indoor air, and community water systems in
such States can then comply with an AMCL of 4000 pCi/L (rather than an
MCL of 300 pCi/L). Under Section 1451 of the SDWA, the Administrator of
EPA is authorized to treat Indian Tribes in the same manner as States.
The proposal provides tribes the option of seeking ``treatment in the
same manner as a State'' for the purposes of assuming enforcement
responsibility for a community water system program, and developing and
implementing an MMM program. If a tribe does not choose to implement an
MMM program, any tribal CWS may develop an MMM program plan for EPA
approval, under the same criteria described previously.
EPA is proposing to amend the ``treatment as a State'' regulations
to allow tribes to be treated in the same manner as States for purposes
of carrying out the MMM program. Under this proposal, a tribe would not
need to demonstrate that it qualified for treatment in the same manner
as a State for any other purpose other than the MMM provisions. Tribes
may want to seek treatment in the same manner as a State for this
limited purpose to the extent that radon is a significant problem on
tribal lands because the MMM program provides an opportunity to focus
resources on reducing the higher risk exposure--indoor air--and
addressing radon in drinking water at the highest levels of exposure.
EPA is proposing to amend the treatment in the same manner as State
regulations (40 CFR 142.72 and 40 CFR 142.78) to obtain treatment as a
State status solely for the purpose of implementing the MMM
authorities. Tribes can, of course, always apply to be treated in the
same manner as a State for primacy over the Public Water Supply Program
under 40 CFR 142.72.
A tribe applying for authority to develop and implement an MMM
program plan that has met the criteria under 40 CFR 142. 72 to be
treated in the same manner as a State for any purpose will not need to
reestablish that it meets the first two criteria (40 CFR 142.72 (a) and
(b)) and needs to provide only information in 40 CFR 142.76 that is
necessary to demonstrate that the criteria in 40 CFR 142.72 (c) and (d)
are met for the MMM program plan. A tribe whose application for
authority to carry out the MMM program is approved must develop and
implement a MMM program plan in accordance with 40 CFR 141.302 and
141.303.
E. CWS Role in State MMM Programs
EPA anticipates that CWSs, especially small systems, would have a
limited role in State-wide MMM programs. For example, States may
develop information brochures on radon that could be distributed
locally by CWSs. EPA expects that States will want to consult with
CWSs, small and large, in
[[Page 59261]]
making a determination about the nature and scope of the role, if any,
of CWSs in implementing a State-wide MMM program. During EPA's
stakeholder process, many States and CWSs agreed that States were best
positioned to design and implement effective State-wide MMM programs
and that it was not apparent what role CWSs might take in such a
program. However, CWSs do have important responsibilities for
communicating information on radon to their customers (see Section
VI.G).
F. Local CWS MMM Programs in Non-MMM States and State Role in Approval
of CWS MMM Program Plans
The regulatory expectation of small community public water systems
(CWSs) is that they meet the AMCL and be associated with a MMM program-
either developed by the State and approved by EPA or developed by the
CWS and approved by the State. EPA strongly recommends that States
choose to develop and implement State-wide MMM programs as the most
cost-effective approach to manage the health risks from radon. In those
cases where States do not elect to do a State-wide MMM program, CWSs
would need to notify the State of its intention to develop and submit a
local MMM program plan to the State (4 years after publication of the
final rule in the Federal Register). EPA believes that, in all cases,
the regulatory burden of complying with AMCL and implementing a MMM
program will be considerably less than complying with the more
stringent regulatory level for radon in drinking water. EPA believes
that the MMM/AMCL is the appropriate standard for CWSs, especially for
small systems, because it results in greater radon risk reduction and
makes better use of limited resources. EPA believes that the four
criteria for plan approval can be applied to CWS local MMM program
plans (as appropriate for the local level), commensurate with the
unique attributes of these CWSs and their service areas. As previously
discussed in more detail, these four criteria are: public
participation, setting quantitative goals, strategies for achieving
goals, and a plan to track and report results.
In general, EPA expects that CWSs would be able to meet the four
criteria by carrying out a wide range of diverse activities, many of
which are well within the expertise of CWSs. However, small CWSs would
not necessarily be expected to perform some of the activities entirely
on their own. In carrying out certain activities, small CWSs would be
expected to seek help from others in order to build upon and take
advantage of existing CWS and State networks. The existing State indoor
radon programs, for example, operate in large measure through a network
of State and local partners such as the American Lung Association, the
National Association of Counties, the National Environmental Health
Association, the National Safety Council, consumer advocacy groups,
non-government organizations, and other local and county governmental
organizations. CWSs should be able to use the same networks and their
capabilities, and State radon in indoor air programs should help
facilitate these contacts. The following provides some additional
perspective on the four criteria relative to CWS MMM programs.
Public Participation: Thorough public participation is certainly
within the capability of CWSs. Systems are often required in the course
of CWS activities, such as operation, maintenance, water bill
collection, violation notification, and planning for new facilities, to
involve, communicate with, inform, and in other ways interact with the
public. Thus, these systems already engage, to a significant degree, in
public outreach and communication. EPA expects that such expertise can
readily be directed toward the particular public participation
requirements associated with MMM programs. Public participating during
development of local MMM plans will help ensure greater local support
for and implementation of the CWS MMM programs.
Quantitative Goals: EPA notes that the quantitative goals that
CWSs, especially small CWSs, typically will need to establish may be
rather modest compared to those that would be expected for State-wide
programs. The level of risk reduction needed to ensure ``equal or
greater'' risk reduction be achieved (as if the MCL were being met)
from a local MMM program plan is a function of and takes into account
factors such as the size of the population served, level of radon in
drinking water, and most importantly, the needs and goals of the
community.
Strategies for Achieving Goals: EPA recognizes that promoting
public action in the areas of new homes built radon-resistant and
mitigation of existing homes with elevated levels of radon in indoor
air will be entirely new ventures for CWSs. However, EPA believes CWSs,
including small CWSs, will be capable of conducting various activities
designed to promote testing and mitigation of existing homes with
elevated levels of radon in indoor air and building of new homes to be
radon-resistant. Such activities include public education programs,
provision of radon test kits, establishing networks with local health
and government officials to gain their support and involvement in MMM
implementation, meeting with community leaders, customers, local real
estate and home building officials and organization, utilizing existing
information distribution network employed by CWSs, and other types of
activities to promote public action on indoor radon. EPA expects that
MMM program strategies for CWSs will be less comprehensive and far
reaching than those of State MMM programs, and will need to reflect the
local character of the community served by the CWS.
Tracking and Reporting of Results: EPA recognizes that assessing or
tracking progress towards meeting these goals also represents a new
responsibility for CWSs. However, CWSs may be able to build upon their
experience and networks for communicating with customers and
identifying their needs or concerns and find ways to collect
information about actions taking place in the community. To track homes
built or modified to be radon resistant, CWSs may be able to obtain
needed information from various local and State programs and offices
and other organizations in its network. CWS may also choose to employ
contractor support or consultant services to obtain this information or
to help track other MMM related activities. EPA also expects the States
to provide assistance to CWSs in developing their tracking and
assessment approach based on State experience in determining the
results of their State indoor radon programs. EPA recognizes that CWSs'
options for tracking results may be more limited than those available
to the States, and that States should consider such limitations in
their five-year review of local programs.
CWSs may find it useful to combine efforts with adjacent CWSs for
purpose of developing and implementing joint MMM programs, thereby
broadening their combined expertise, local infrastructure and
institutional bases, and network of partners. EPA also expects that
privately-owned, as well as publicly owned, CWSs can avail themselves
of these same kinds of networks, partnership, and consultant services.
Private systems will generally also be well connected to the municipal
entities in the jurisdictions in which they operate.
The report of the Small Business Advocacy Review Panel included a
discussion of the concept of a ``model MMM program'' for small systems
which would not be required but could
[[Page 59262]]
provide a workable option for small systems. It might address potential
concerns of the smallest systems that anticipate they may lack the
resources and expertise to develop an MMM program. As discussed
subsequently in Section VI. H., EPA has concerns in general about the
appropriateness and applicability of a ``one-size-fits-all'' approach
for MMM programs. A model approach, even for small CWSs, would not
address the unique, site-specific needs of different CWSs and their
associated communities. EPA is requesting public comment on the concept
of a model MMM program for CWSs.
As noted previously, EPA is strongly recommending that States
choose to develop and implement State-wide MMM programs as the most
cost-effective approach to manage the health risks from radon which
would preclude the need for water systems to develop such programs on
their own. EPA also believes the States which choose not to do an MMM
program have an important role, and are the best positioned, to assist
CWSs in development of local MMM program plans. EPA will also be
providing guidance to assist CWSs, including small CWSs, in the
development of local MMM programs. This section has discussed the
manner in which the four criteria could be applied to CWSs in non-MMM
States. EPA is requesting comment on approaches to applying these
criteria to CWSs, especially the smallest CWSs, in view of the
capabilities of these systems and their ability to get assistance from
others. EPA is also requesting comment on options that may be available
to CWSs, particularly, small systems, to develop and implement an MMM
program plan.
In summary, EPA recognizes that CWSs do not have the same
institutional base and infrastructure, legislative authority,
proportionate resource base, or indoor radon program experience as
States on which to base development of a local MMM program plan.
However, EPA believes that the four criteria for approval are equally
applicable to both States and CWSs, and can be applied to CWSs
(particularly small CWSs) in a manner that recognizes and accounts for
these differences. As discussed previously, the manner in which these
criteria are addressed by CWSs in local MMM program plans, and the
level and scope of effort, will necessarily differ from that embodied
in State plans. States should consider these differences in evaluating
CWS MMM program plans and in their five-year review of CWS MMM program
implementation. EPA believes that States, in particular, are best
positioned to assist CWSs, especially small systems, in the development
of local MMM programs that satisfy the four criteria, and expects them
to provide such assistance. In evaluating CWS plans, States should
exercise flexibility in their review and approval process, especially
for small CWSs, recognizing that they will not have the same
institutional and resource base or experience and may need to obtain
assistance from others.
The Agency expects that most systems in non-MMM States with radon
levels between 4,000 pCi/L and 300 pCi/L will develop and submit MMM
program plans. However, the Agency recognizes that some CWSs in non-MMM
States may elect not to develop a MMM program plan for a variety of
reasons. In these cases, certain options are available to small CWSs.
They may consider working with one or more other systems for the
purposes of developing and implementing an MMM program plan, in order
to take advantage of greater institutional capabilities. If a system
does not develop an MMM program plan on its own or together with other
systems, the system must comply with the MCL of 300 pCi/L through any
available means (e.g., blending, use of alternate sources, and
treatment).
From a risk communication standpoint, EPA wishes to convey to
customers of small CWSs that its regulatory expectation for these
systems is that they meet the AMCL and implement an MMM program.
However, CWSs can choose to meet the MCL rather than take the MMM
approach. If a CWS opts for the MMM/AMCL approach but is unable to
develop and successfully implement a State-approved MMM program plan,
it may be required as part of an enforcement order, to meet the MCL
rather than comply with the MMM/AMCL. The Agency requests comment on
this approach for small system MMM programs.
The SDWA provides that EPA will approve local water system MMM
program plans and EPA has developed the criteria to be used for
approving MMM program plans, as discussed in (A). EPA will review and
approve State MMM program plans. CWS MMM program plans that address the
criteria and are approved by the State are deemed approved by EPA. The
proposed rule requires States that do not have a State-wide MMM
program, as a condition of primacy for the radon regulation, to review
MMM program plans submitted by CWSs and to approve plans meeting the
four criteria for MMM program plans discussed in Section VI.A. of this,
including providing notice and opportunity for public comment on CWS
MMM program plans. EPA solicits comment on this approach to reviewing
and approving local MMM plans. Under SDWA, MMM program plans submitted
by CWSs are to be subject to the same criteria and conditions as State
MMM program plans. EPA believes that the States are best positioned to
assist CWSs, especially small systems, in the development and review of
local MMM program plans that meet the four criteria, and to have public
health oversight of the progress of the implementation of these local
radon risk reduction programs. EPA encourages those States not choosing
to develop a State-wide MMM program plan to exercise flexibility in
their review and approval of local MMM program plans, especially for
small CWSs, recognizing that CWSs will not have the same institutional
base, nor the State's program experience on indoor radon, on which to
base to local development of a MMM program plan. EPA expects that the
State drinking water programs and indoor radon programs will work
collaboratively in assisting CWSs that elect to develop and implement
local CWS MMM program plans and comply with the AMCL. In non-primacy
states, EPA will review and approve local CWS MMM program plans and
oversee compliance with the AMCL if the state chooses not to do a
state-wide MMM program plan. MMM program plans developed by Indian
Tribes or tribal community water systems will be reviewed by EPA. The
specific requirements of a CWS in a State with a State-wide MMM program
are addressed in Section VI.E. CWSs may choose to meet the MCL.
For those CWSs (both large and small) in non-MMM States that
develop local MMM program plans, the State would review the MMM program
at least once every 5 years and provide progress reports to the EPA in
keeping with the statutory requirements of the SDWA and this Section.
(States may also establish interim reporting requirements for the CWS
under a MMM program to help ensure adequate progress toward the goals
set forth in the local MMM program plan.) Failure of a CWS to develop
its MMM program plan by the required regulatory deadline or failure of
a CWS to implement its approved MMM program plan (5 years and 5\1/2\
years, respectively after the final rule is published) would be a
violation of this regulation unless the CWS is complying with the MCL.
It is expected that a CWS would be given time to correct any violations
relating to its MMM program
[[Page 59263]]
through an appropriate enforcement action.
G. CWS Role in Communicating to Customers
At a minimum, CWSs have important responsibilities for
communicating information on radon to their customers. Under the
requirements of the Consumer Confidence Rule (CCR), CWSs will be
required to provide key information on the health effects of radon
should the level of radon in drinking water exceed the MCL (or AMCL in
States with MMM programs). Today's action also updates the standard CCR
rule requirements and adds special requirements that reflect the
multimedia approach of this rule. The intent of these provisions is to
assist in clearer communication of the relative risks of radon in
indoor air from soil and from drinking water, and to encourage public
participation in the development of the State or CWS MMM program plans.
Today's action also proposes to require CWSs to add information to the
mandatory yearly report which would inform their customers on how to
get involved in developing their State or local CWS MMM program plan.
This information would include a brief educational statement on radon
risks, explaining that the principal radon risk comes from radon in
indoor air, rather than drinking water, and for that reason, radon risk
reduction efforts may be focused on indoor air rather than drinking
water. This information will also note that many States and systems are
in the process of creating programs to reduce exposure to radon, and
encourage readers to call for more information. This information would
be provided every year until the compliance date for implementation of
State MMM programs (or CWS local MMM programs in States without a
State-wide MMM program. (See Section X of this preamble for more
information on CCR and public notice requirements for radon). EPA is
also planning to develop public information materials on radon in
drinking water and indoor air as ``tools'' to assist CWSs, as well as
the States, Indian tribes, and others, with the risk communication
issues associated with the MCL, AMCL, and MMM.
H. How Did EPA Develop These Criteria?
EPA obtained extensive stakeholder input in developing the
regulatory criteria for State MMM program plans. Stakeholders
participating in this process represented many diverse groups and
organizations with an interest in radon, both from the perspective of
radon in drinking water and of radon in indoor air. This included State
drinking water and State radon program representatives, municipal and
privately owned public water system suppliers, local government
officials, environmental groups, and organizations representing State
health officials, county governments, public interest groups, and
others.
As part of the process of getting stakeholder input on development
of MMM guidelines and criteria, EPA presented several conceptual
framework options for MMM for discussion and consideration. Three
preliminary approaches were discussed: (1) To set specific numerical
targets in mitigations of existing houses and houses built radon-
resistant (as surrogates for lives saved) for each State to meet; (2)
to set a level of effort that States must demonstrate would be achieved
under their MMM plan; and (3) to set minimum core indoor radon program
elements required for all plans.
Under the first approach, specific targets to achieve ``equal''
risk reduction could be set using a variety of approaches and tools and
based on a number of factors, such as the level of radon in the
drinking water, the number of people served by that system, and other
factors. It would also require allocating among the States the total
number of lives saved nationally by universal compliance with the MCL
(estimated to be about 62 lives saved yearly). The allocation of lives
saved by States would likely lead to some State targets being fractions
of a life saved yearly, depending on the number of systems, radon
levels, and people served. Many stakeholders thought that significant
attention would need to be paid to the risk communication challenges of
communicating this approach to the public. Although some stakeholders
thought this approach might be workable, others did not consider it
universally applicable or workable and that it might preclude
flexibility and innovation.
The second approach, ``level of effort'', would focus more on a
plan for implementation of risk reduction strategies using a point
system where different risk reduction strategies (such as public
education, radon-resistant new construction code adoption, etc.) would
be assigned a specific number of points based on potential to achieve
health risk reduction. The number of State-specific points that a MMM
program plan would have to meet to be approved would require
determining the number of systems complying with the AMCL rather than
the MCL, the radon levels in their drinking water, and |
