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U.S. Code as of:
01/19/04
Section 300g-1. National drinking water regulations
(a) National primary drinking water regulations; maximum
contaminant level goals; simultaneous publication of regulations
and goals
(1) Effective on June 19, 1986, each national interim or revised
primary drinking water regulation promulgated under this section
before June 19, 1986, shall be deemed to be a national primary
drinking water regulation under subsection (b) of this section. No
such regulation shall be required to comply with the standards set
forth in subsection (b)(4) of this section unless such regulation
is amended to establish a different maximum contaminant level after
June 19, 1986.
(2) After June 19, 1986, each recommended maximum contaminant
level published before June 19, 1986, shall be treated as a maximum
contaminant level goal.
(3) Whenever a national primary drinking water regulation is
proposed under subsection (b) of this section for any contaminant,
the maximum contaminant level goal for such contaminant shall be
proposed simultaneously. Whenever a national primary drinking water
regulation is promulgated under subsection (b) of this section for
any contaminant, the maximum contaminant level goal for such
contaminant shall be published simultaneously.
(4) Paragraph (3) shall not apply to any recommended maximum
contaminant level published before June 19, 1986.
(b) Standards
(1) Identification of contaminants for listing. -
(A) General authority. - The Administrator shall, in accordance
with the procedures established by this subsection, publish a
maximum contaminant level goal and promulgate a national primary
drinking water regulation for a contaminant (other than a
contaminant referred to in paragraph (2) for which a national
primary drinking water regulation has been promulgated as of
August 6, 1996) if the Administrator determines that -
(i) the contaminant may have an adverse effect on the health
of persons;
(ii) the contaminant is known to occur or there is a
substantial likelihood that the contaminant will occur in
public water systems with a frequency and at levels of public
health concern; and
(iii) in the sole judgment of the Administrator, regulation
of such contaminant presents a meaningful opportunity for
health risk reduction for persons served by public water
systems.
(B) Regulation of unregulated contaminants. -
(i) Listing of contaminants for consideration. - (I) Not
later than 18 months after August 6, 1996, and every 5 years
thereafter, the Administrator, after consultation with the
scientific community, including the Science Advisory Board,
after notice and opportunity for public comment, and after
considering the occurrence data base established under section
300j-4(g) of this title, shall publish a list of contaminants
which, at the time of publication, are not subject to any
proposed or promulgated national primary drinking water
regulation, which are known or anticipated to occur in public
water systems, and which may require regulation under this
subchapter.
(II) The unregulated contaminants considered under subclause
(I) shall include, but not be limited to, substances referred
to in section 9601(14) of this title, and substances registered
as pesticides under the Federal Insecticide, Fungicide, and
Rodenticide Act [7 U.S.C. 136 et seq.].
(III) The Administrator's decision whether or not to select
an unregulated contaminant for a list under this clause shall
not be subject to judicial review.
(ii) Determination to regulate. - (I) Not later than 5 years
after August 6, 1996, and every 5 years thereafter, the
Administrator shall, after notice of the preliminary
determination and opportunity for public comment, for not fewer
than 5 contaminants included on the list published under clause
(i), make determinations of whether or not to regulate such
contaminants.
(II) A determination to regulate a contaminant shall be based
on findings that the criteria of clauses (i), (ii), and (iii)
of subparagraph (A) are satisfied. Such findings shall be based
on the best available public health information, including the
occurrence data base established under section 300j-4(g) of
this title.
(III) The Administrator may make a determination to regulate
a contaminant that does not appear on a list under clause (i)
if the determination to regulate is made pursuant to subclause
(II).
(IV) A determination under this clause not to regulate a
contaminant shall be considered final agency action and subject
to judicial review.
(iii) Review. - Each document setting forth the determination
for a contaminant under clause (ii) shall be available for
public comment at such time as the determination is published.
(C) Priorities. - In selecting unregulated contaminants for
consideration under subparagraph (B), the Administrator shall
select contaminants that present the greatest public health
concern. The Administrator, in making such selection, shall take
into consideration, among other factors of public health concern,
the effect of such contaminants upon subgroups that comprise a
meaningful portion of the general population (such as infants,
children, pregnant women, the elderly, individuals with a history
of serious illness, or other subpopulations) that are
identifiable as being at greater risk of adverse health effects
due to exposure to contaminants in drinking water than the
general population.
(D) Urgent threats to public health. - The Administrator may
promulgate an interim national primary drinking water regulation
for a contaminant without making a determination for the
contaminant under paragraph (4)(C), or completing the analysis
under paragraph (3)(C), to address an urgent threat to public
health as determined by the Administrator after consultation with
and written response to any comments provided by the Secretary of
Health and Human Services, acting through the director of the
Centers for Disease Control and Prevention or the director of the
National Institutes of Health. A determination for any
contaminant in accordance with paragraph (4)(C) subject to an
interim regulation under this subparagraph shall be issued, and a
completed analysis meeting the requirements of paragraph (3)(C)
shall be published, not later than 3 years after the date on
which the regulation is promulgated and the regulation shall be
repromulgated, or revised if appropriate, not later than 5 years
after that date.
(E) Regulation. - For each contaminant that the Administrator
determines to regulate under subparagraph (B), the Administrator
shall publish maximum contaminant level goals and promulgate, by
rule, national primary drinking water regulations under this
subsection. The Administrator shall propose the maximum
contaminant level goal and national primary drinking water
regulation for a contaminant not later than 24 months after the
determination to regulate under subparagraph (B), and may publish
such proposed regulation concurrent with the determination to
regulate. The Administrator shall publish a maximum contaminant
level goal and promulgate a national primary drinking water
regulation within 18 months after the proposal thereof. The
Administrator, by notice in the Federal Register, may extend the
deadline for such promulgation for up to 9 months.
(F) Health advisories and other actions. - The Administrator
may publish health advisories (which are not regulations) or take
other appropriate actions for contaminants not subject to any
national primary drinking water regulation.
(2) Schedules and deadlines. -
(A) In general. - In the case of the contaminants listed in the
Advance Notice of Proposed Rulemaking published in volume 47,
Federal Register, page 9352, and in volume 48, Federal Register,
page 45502, the Administrator shall publish maximum contaminant
level goals and promulgate national primary drinking water
regulations -
(i) not later than 1 year after June 19, 1986, for not fewer
than 9 of the listed contaminants;
(ii) not later than 2 years after June 19, 1986, for not
fewer than 40 of the listed contaminants; and
(iii) not later than 3 years after June 19, 1986, for the
remainder of the listed contaminants.
(B) Substitution of contaminants. - If the Administrator
identifies a drinking water contaminant the regulation of which,
in the judgment of the Administrator, is more likely to be
protective of public health (taking into account the schedule for
regulation under subparagraph (A)) than a contaminant referred to
in subparagraph (A), the Administrator may publish a maximum
contaminant level goal and promulgate a national primary drinking
water regulation for the identified contaminant in lieu of
regulating the contaminant referred to in subparagraph (A).
Substitutions may be made for not more than 7 contaminants
referred to in subparagraph (A). Regulation of a contaminant
identified under this subparagraph shall be in accordance with
the schedule applicable to the contaminant for which the
substitution is made.
(C) Disinfectants and disinfection byproducts. - The
Administrator shall promulgate an Interim Enhanced Surface Water
Treatment Rule, a Final Enhanced Surface Water Treatment Rule, a
Stage I Disinfectants and Disinfection Byproducts Rule, and a
Stage II Disinfectants and Disinfection Byproducts Rule in
accordance with the schedule published in volume 59, Federal
Register, page 6361 (February 10, 1994), in table III.13 of the
proposed Information Collection Rule. If a delay occurs with
respect to the promulgation of any rule in the schedule referred
to in this subparagraph, all subsequent rules shall be completed
as expeditiously as practicable but no later than a revised date
that reflects the interval or intervals for the rules in the
schedule.
(3) Risk assessment, management, and communication. -
(A) Use of science in decisionmaking. - In carrying out this
section, and, to the degree that an Agency action is based on
science, the Administrator shall use -
(i) the best available, peer-reviewed science and supporting
studies conducted in accordance with sound and objective
scientific practices; and
(ii) data collected by accepted methods or best available
methods (if the reliability of the method and the nature of the
decision justifies use of the data).
(B) Public information. - In carrying out this section, the
Administrator shall ensure that the presentation of information
on public health effects is comprehensive, informative, and
understandable. The Administrator shall, in a document made
available to the public in support of a regulation promulgated
under this section, specify, to the extent practicable -
(i) each population addressed by any estimate of public
health effects;
(ii) the expected risk or central estimate of risk for the
specific populations;
(iii) each appropriate upper-bound or lower-bound estimate of
risk;
(iv) each significant uncertainty identified in the process
of the assessment of public health effects and studies that
would assist in resolving the uncertainty; and
(v) peer-reviewed studies known to the Administrator that
support, are directly relevant to, or fail to support any
estimate of public health effects and the methodology used to
reconcile inconsistencies in the scientific data.
(C) Health risk reduction and cost analysis. -
(i) Maximum contaminant levels. - When proposing any national
primary drinking water regulation that includes a maximum
contaminant level, the Administrator shall, with respect to a
maximum contaminant level that is being considered in
accordance with paragraph (4) and each alternative maximum
contaminant level that is being considered pursuant to
paragraph (5) or (6)(A), publish, seek public comment on, and
use for the purposes of paragraphs (4), (5), and (6) an
analysis of each of the following:
(I) Quantifiable and nonquantifiable health risk reduction
benefits for which there is a factual basis in the rulemaking
record to conclude that such benefits are likely to occur as
the result of treatment to comply with each level.
(II) Quantifiable and nonquantifiable health risk reduction
benefits for which there is a factual basis in the rulemaking
record to conclude that such benefits are likely to occur
from reductions in co-occurring contaminants that may be
attributed solely to compliance with the maximum contaminant
level, excluding benefits resulting from compliance with
other proposed or promulgated regulations.
(III) Quantifiable and nonquantifiable costs for which
there is a factual basis in the rulemaking record to conclude
that such costs are likely to occur solely as a result of
compliance with the maximum contaminant level, including
monitoring, treatment, and other costs and excluding costs
resulting from compliance with other proposed or promulgated
regulations.
(IV) The incremental costs and benefits associated with
each alternative maximum contaminant level considered.
(V) The effects of the contaminant on the general
population and on groups within the general population such
as infants, children, pregnant women, the elderly,
individuals with a history of serious illness, or other
subpopulations that are identified as likely to be at greater
risk of adverse health effects due to exposure to
contaminants in drinking water than the general population.
(VI) Any increased health risk that may occur as the result
of compliance, including risks associated with co-occurring
contaminants.
(VII) Other relevant factors, including the quality and
extent of the information, the uncertainties in the analysis
supporting subclauses (I) through (VI), and factors with
respect to the degree and nature of the risk.
(ii) Treatment techniques. - When proposing a national
primary drinking water regulation that includes a treatment
technique in accordance with paragraph (7)(A), the
Administrator shall publish and seek public comment on an
analysis of the health risk reduction benefits and costs likely
to be experienced as the result of compliance with the
treatment technique and alternative treatment techniques that
are being considered, taking into account, as appropriate, the
factors described in clause (i).
(iii) Approaches to measure and value benefits. - The
Administrator may identify valid approaches for the measurement
and valuation of benefits under this subparagraph, including
approaches to identify consumer willingness to pay for
reductions in health risks from drinking water contaminants.
(iv) Authorization. - There are authorized to be appropriated
to the Administrator, acting through the Office of Ground Water
and Drinking Water, to conduct studies, assessments, and
analyses in support of regulations or the development of
methods, $35,000,000 for each of fiscal years 1996 through
2003.
(4) Goals and standards. -
(A) Maximum contaminant level goals. - Each maximum contaminant
level goal established under this subsection shall be set at the
level at which no known or anticipated adverse effects on the
health of persons occur and which allows an adequate margin of
safety.
(B) Maximum contaminant levels. - Except as provided in
paragraphs (5) and (6), each national primary drinking water
regulation for a contaminant for which a maximum contaminant
level goal is established under this subsection shall specify a
maximum contaminant level for such contaminant which is as close
to the maximum contaminant level goal as is feasible.
(C) Determination. - At the time the Administrator proposes a
national primary drinking water regulation under this paragraph,
the Administrator shall publish a determination as to whether the
benefits of the maximum contaminant level justify, or do not
justify, the costs based on the analysis conducted under
paragraph (3)(C).
(D) Definition of feasible. - For the purposes of this
subsection, the term "feasible" means feasible with the use of
the best technology, treatment techniques and other means which
the Administrator finds, after examination for efficacy under
field conditions and not solely under laboratory conditions, are
available (taking cost into consideration). For the purpose of
this paragraph, granular activated carbon is feasible for the
control of synthetic organic chemicals, and any technology,
treatment technique, or other means found to be the best
available for the control of synthetic organic chemicals must be
at least as effective in controlling synthetic organic chemicals
as granular activated carbon.
(E) Feasible technologies. -
(i) In general. - Each national primary drinking water
regulation which establishes a maximum contaminant level shall
list the technology, treatment techniques, and other means
which the Administrator finds to be feasible for purposes of
meeting such maximum contaminant level, but a regulation under
this subsection shall not require that any specified
technology, treatment technique, or other means be used for
purposes of meeting such maximum contaminant level.
(ii) List of technologies for small systems. - The
Administrator shall include in the list any technology,
treatment technique, or other means that is affordable, as
determined by the Administrator in consultation with the
States, for small public water systems serving -
(I) a population of 10,000 or fewer but more than 3,300;
(II) a population of 3,300 or fewer but more than 500; and
(III) a population of 500 or fewer but more than 25;
and that achieves compliance with the maximum contaminant level
or treatment technique, including packaged or modular systems
and point-of-entry or point-of-use treatment units.
Point-of-entry and point-of-use treatment units shall be owned,
controlled and maintained by the public water system or by a
person under contract with the public water system to ensure
proper operation and maintenance and compliance with the
maximum contaminant level or treatment technique and equipped
with mechanical warnings to ensure that customers are
automatically notified of operational problems. The
Administrator shall not include in the list any point-of-use
treatment technology, treatment technique, or other means to
achieve compliance with a maximum contaminant level or
treatment technique requirement for a microbial contaminant (or
an indicator of a microbial contaminant). If the American
National Standards Institute has issued product standards
applicable to a specific type of point-of-entry or point-of-use
treatment unit, individual units of that type shall not be
accepted for compliance with a maximum contaminant level or
treatment technique requirement unless they are independently
certified in accordance with such standards. In listing any
technology, treatment technique, or other means pursuant to
this clause, the Administrator shall consider the quality of
the source water to be treated.
(iii) List of technologies that achieve compliance. - Except
as provided in clause (v), not later than 2 years after August
6, 1996, and after consultation with the States, the
Administrator shall issue a list of technologies that achieve
compliance with the maximum contaminant level or treatment
technique for each category of public water systems described
in subclauses (I), (II), and (III) of clause (ii) for each
national primary drinking water regulation promulgated prior to
June 19, 1986.
(iv) Additional technologies. - The Administrator may, at any
time after a national primary drinking water regulation has
been promulgated, supplement the list of technologies
describing additional or new or innovative treatment
technologies that meet the requirements of this paragraph for
categories of small public water systems described in
subclauses (I), (II), and (III) of clause (ii) that are subject
to the regulation.
(v) Technologies that meet surface water treatment rule. -
Within one year after August 6, 1996, the Administrator shall
list technologies that meet the Surface Water Treatment Rule
for each category of public water systems described in
subclauses (I), (II), and (III) of clause (ii).
(5) Additional health risk considerations. -
(A) In general. - Notwithstanding paragraph (4), the
Administrator may establish a maximum contaminant level for a
contaminant at a level other than the feasible level, if the
technology, treatment techniques, and other means used to
determine the feasible level would result in an increase in the
health risk from drinking water by -
(i) increasing the concentration of other contaminants in
drinking water; or
(ii) interfering with the efficacy of drinking water
treatment techniques or processes that are used to comply with
other national primary drinking water regulations.
(B) Establishment of level. - If the Administrator establishes
a maximum contaminant level or levels or requires the use of
treatment techniques for any contaminant or contaminants pursuant
to the authority of this paragraph -
(i) the level or levels or treatment techniques shall
minimize the overall risk of adverse health effects by
balancing the risk from the contaminant and the risk from other
contaminants the concentrations of which may be affected by the
use of a treatment technique or process that would be employed
to attain the maximum contaminant level or levels; and
(ii) the combination of technology, treatment techniques, or
other means required to meet the level or levels shall not be
more stringent than is feasible (as defined in paragraph
(4)(D)).
(6) Additional health risk reduction and cost considerations. -
(A) In general. - Notwithstanding paragraph (4), if the
Administrator determines based on an analysis conducted under
paragraph (3)(C) that the benefits of a maximum contaminant level
promulgated in accordance with paragraph (4) would not justify
the costs of complying with the level, the Administrator may,
after notice and opportunity for public comment, promulgate a
maximum contaminant level for the contaminant that maximizes
health risk reduction benefits at a cost that is justified by the
benefits.
(B) Exception. - The Administrator shall not use the authority
of this paragraph to promulgate a maximum contaminant level for a
contaminant, if the benefits of compliance with a national
primary drinking water regulation for the contaminant that would
be promulgated in accordance with paragraph (4) experienced by -
(i) persons served by large public water systems; and
(ii) persons served by such other systems as are unlikely,
based on information provided by the States, to receive a
variance under section 300g-4(e) of this title (relating to
small system variances);
would justify the costs to the systems of complying with the
regulation. This subparagraph shall not apply if the contaminant
is found almost exclusively in small systems eligible under
section 300g-4(e) of this title for a small system variance.
(C) Disinfectants and disinfection byproducts. - The
Administrator may not use the authority of this paragraph to
establish a maximum contaminant level in a Stage I or Stage II
national primary drinking water regulation (as described in
paragraph (2)(C)) for contaminants that are disinfectants or
disinfection byproducts, or to establish a maximum contaminant
level or treatment technique requirement for the control of
cryptosporidium. The authority of this paragraph may be used to
establish regulations for the use of disinfection by systems
relying on ground water sources as required by paragraph (8).
(D) Judicial review. - A determination by the Administrator
that the benefits of a maximum contaminant level or treatment
requirement justify or do not justify the costs of complying with
the level shall be reviewed by the court pursuant to section
300j-7 of this title only as part of a review of a final national
primary drinking water regulation that has been promulgated based
on the determination and shall not be set aside by the court
under that section unless the court finds that the determination
is arbitrary and capricious.
(7)(A) The Administrator is authorized to promulgate a national
primary drinking water regulation that requires the use of a
treatment technique in lieu of establishing a maximum contaminant
level, if the Administrator makes a finding that it is not
economically or technologically feasible to ascertain the level of
the contaminant. In such case, the Administrator shall identify
those treatment techniques which, in the Administrator's judgment,
would prevent known or anticipated adverse effects on the health of
persons to the extent feasible. Such regulations shall specify each
treatment technique known to the Administrator which meets the
requirements of this paragraph, but the Administrator may grant a
variance from any specified treatment technique in accordance with
section 300g-4(a)(3) of this title.
(B) Any schedule referred to in this subsection for the
promulgation of a national primary drinking water regulation for
any contaminant shall apply in the same manner if the regulation
requires a treatment technique in lieu of establishing a maximum
contaminant level.
(C)(i) Not later than 18 months after June 19, 1986, the
Administrator shall propose and promulgate national primary
drinking water regulations specifying criteria under which
filtration (including coagulation and sedimentation, as
appropriate) is required as a treatment technique for public water
systems supplied by surface water sources. In promulgating such
rules, the Administrator shall consider the quality of source
waters, protection afforded by watershed management, treatment
practices (such as disinfection and length of water storage) and
other factors relevant to protection of health.
(ii) In lieu of the provisions of section 300g-4 of this title
the Administrator shall specify procedures by which the State
determines which public water systems within its jurisdiction shall
adopt filtration under the criteria of clause (i). The State may
require the public water system to provide studies or other
information to assist in this determination. The procedures shall
provide notice and opportunity for public hearing on this
determination. If the State determines that filtration is required,
the State shall prescribe a schedule for compliance by the public
water system with the filtration requirement. A schedule shall
require compliance within 18 months of a determination made under
clause (iii).
(iii) Within 18 months from the time that the Administrator
establishes the criteria and procedures under this subparagraph, a
State with primary enforcement responsibility shall adopt any
necessary regulations to implement this subparagraph. Within 12
months of adoption of such regulations the State shall make
determinations regarding filtration for all the public water
systems within its jurisdiction supplied by surface waters.
(iv) If a State does not have primary enforcement responsibility
for public water systems, the Administrator shall have the same
authority to make the determination in clause (ii) in such State as
the State would have under that clause. Any filtration requirement
or schedule under this subparagraph shall be treated as if it were
a requirement of a national primary drinking water regulation.
(v) As an additional alternative to the regulations promulgated
pursuant to clauses (i) and (iii), including the criteria for
avoiding filtration contained in 40 CFR 141.71, a State exercising
primary enforcement responsibility for public water systems may, on
a case-by-case basis, and after notice and opportunity for public
comment, establish treatment requirements as an alternative to
filtration in the case of systems having uninhabited, undeveloped
watersheds in consolidated ownership, and having control over
access to, and activities in, those watersheds, if the State
determines (and the Administrator concurs) that the quality of the
source water and the alternative treatment requirements established
by the State ensure greater removal or inactivation efficiencies of
pathogenic organisms for which national primary drinking water
regulations have been promulgated or that are of public health
concern than would be achieved by the combination of filtration and
chlorine disinfection (in compliance with this section).
(8) Disinfection. - At any time after the end of the 3-year
period that begins on August 6, 1996, but not later than the date
on which the Administrator promulgates a Stage II rulemaking for
disinfectants and disinfection byproducts (as described in
paragraph (2)(C)), the Administrator shall also promulgate national
primary drinking water regulations requiring disinfection as a
treatment technique for all public water systems, including surface
water systems and, as necessary, ground water systems. After
consultation with the States, the Administrator shall (as part of
the regulations) promulgate criteria that the Administrator, or a
State that has primary enforcement responsibility under section
300g-2 of this title, shall apply to determine whether disinfection
shall be required as a treatment technique for any public water
system served by ground water. The Administrator shall
simultaneously promulgate a rule specifying criteria that will be
used by the Administrator (or delegated State authorities) to grant
variances from this requirement according to the provisions of
sections 300g-4(a)(1)(B) and 300g-4(a)(3) of this title. In
implementing section 300j-1(e) of this title the Administrator or
the delegated State authority shall, where appropriate, give
special consideration to providing technical assistance to small
public water systems in complying with the regulations promulgated
under this paragraph.
(9) Review and revision. - The Administrator shall, not less
often than every 6 years, review and revise, as appropriate, each
national primary drinking water regulation promulgated under this
subchapter. Any revision of a national primary drinking water
regulation shall be promulgated in accordance with this section,
except that each revision shall maintain, or provide for greater,
protection of the health of persons.
(10) Effective date. - A national primary drinking water
regulation promulgated under this section (and any amendment
thereto) shall take effect on the date that is 3 years after the
date on which the regulation is promulgated unless the
Administrator determines that an earlier date is practicable,
except that the Administrator, or a State (in the case of an
individual system), may allow up to 2 additional years to comply
with a maximum contaminant level or treatment technique if the
Administrator or State (in the case of an individual system)
determines that additional time is necessary for capital
improvements.
(11) No national primary drinking water regulation may require
the addition of any substance for preventive health care purposes
unrelated to contamination of drinking water.
(12) Certain contaminants. -
(A) Arsenic. -
(i) Schedule and standard. - Notwithstanding the deadlines
set forth in paragraph (1), the Administrator shall promulgate
a national primary drinking water regulation for arsenic
pursuant to this subsection, in accordance with the schedule
established by this paragraph.
(ii) Study plan. - Not later than 180 days after August 6,
1996, the Administrator shall develop a comprehensive plan for
study in support of drinking water rulemaking to reduce the
uncertainty in assessing health risks associated with exposure
to low levels of arsenic. In conducting such study, the
Administrator shall consult with the National Academy of
Sciences, other Federal agencies, and interested public and
private entities.
(iii) Cooperative agreements. - In carrying out the study
plan, the Administrator may enter into cooperative agreements
with other Federal agencies, State and local governments, and
other interested public and private entities.
(iv) Proposed regulations. - The Administrator shall propose
a national primary drinking water regulation for arsenic not
later than January 1, 2000.
(v) Final regulations. - Not later than January 1, 2001,
after notice and opportunity for public comment, the
Administrator shall promulgate a national primary drinking
water regulation for arsenic.
(vi) Authorization. - There are authorized to be appropriated
$2,500,000 for each of fiscal years 1997 through 2000 for the
studies required by this paragraph.
(B) Sulfate. -
(i) Additional study. - Prior to promulgating a national
primary drinking water regulation for sulfate, the
Administrator and the Director of the Centers for Disease
Control and Prevention shall jointly conduct an additional
study to establish a reliable dose-response relationship for
the adverse human health effects that may result from exposure
to sulfate in drinking water, including the health effects that
may be experienced by groups within the general population
(including infants and travelers) that are potentially at
greater risk of adverse health effects as the result of such
exposure. The study shall be conducted in consultation with
interested States, shall be based on the best available,
peer-reviewed science and supporting studies conducted in
accordance with sound and objective scientific practices, and
shall be completed not later than 30 months after August 6,
1996.
(ii) Determination. - The Administrator shall include sulfate
among the 5 or more contaminants for which a determination is
made pursuant to paragraph (3)(B) not later than 5 years after
August 6, 1996.
(iii) Proposed and final rule. - Notwithstanding the
deadlines set forth in paragraph (2), the Administrator may,
pursuant to the authorities of this subsection and after notice
and opportunity for public comment, promulgate a final national
primary drinking water regulation for sulfate. Any such
regulation shall include requirements for public notification
and options for the provision of alternative water supplies to
populations at risk as a means of complying with the regulation
in lieu of a best available treatment technology or other
means.
(13) Radon in drinking water. -
(A) National primary drinking water regulation. -
Notwithstanding paragraph (2), the Administrator shall withdraw
any national primary drinking water regulation for radon proposed
prior to August 6, 1996, and shall propose and promulgate a
regulation for radon under this section, as amended by the Safe
Drinking Water Act Amendments of 1996.
(B) Risk assessment and studies. -
(i) Assessment by nas. - Prior to proposing a national
primary drinking water regulation for radon, the Administrator
shall arrange for the National Academy of Sciences to prepare a
risk assessment for radon in drinking water using the best
available science in accordance with the requirements of
paragraph (3). The risk assessment shall consider each of the
risks associated with exposure to radon from drinking water and
consider studies on the health effects of radon at levels and
under conditions likely to be experienced through residential
exposure. The risk assessment shall be peer-reviewed.
(ii) Study of other measures. - The Administrator shall
arrange for the National Academy of Sciences to prepare an
assessment of the health risk reduction benefits associated
with various mitigation measures to reduce radon levels in
indoor air. The assessment may be conducted as part of the risk
assessment authorized by clause (i) and shall be used by the
Administrator to prepare the guidance and approve State
programs under subparagraph (G).
(iii) Other organization. - If the National Academy of
Sciences declines to prepare the risk assessment or studies
required by this subparagraph, the Administrator shall enter
into a contract or cooperative agreement with another
independent, scientific organization to prepare such
assessments or studies.
(C) Health risk reduction and cost analysis. - Not later than
30 months after August 6, 1996, the Administrator shall publish,
and seek public comment on, a health risk reduction and cost
analysis meeting the requirements of paragraph (3)(C) for
potential maximum contaminant levels that are being considered
for radon in drinking water. The Administrator shall include a
response to all significant public comments received on the
analysis with the preamble for the proposed rule published under
subparagraph (D).
(D) Proposed regulation. - Not later than 36 months after
August 6, 1996, the Administrator shall propose a maximum
contaminant level goal and a national primary drinking water
regulation for radon pursuant to this section.
(E) Final regulation. - Not later than 12 months after the date
of the proposal under subparagraph (D), the Administrator shall
publish a maximum contaminant level goal and promulgate a
national primary drinking water regulation for radon pursuant to
this section based on the risk assessment prepared pursuant to
subparagraph (B) and the health risk reduction and cost analysis
published pursuant to subparagraph (C). In considering the risk
assessment and the health risk reduction and cost analysis in
connection with the promulgation of such a standard, the
Administrator shall take into account the costs and benefits of
control programs for radon from other sources.
(F) Alternative maximum contaminant level. - If the maximum
contaminant level for radon in drinking water promulgated
pursuant to subparagraph (E) 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, the Administrator
shall, simultaneously with the promulgation of such level,
promulgate an alternative maximum contaminant level for radon
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 the Administrator
promulgates an alternative maximum contaminant level under this
subparagraph, the Administrator shall, after notice and
opportunity for public comment and in consultation with the
States, publish guidelines for State programs, including criteria
for multimedia measures to mitigate radon levels in indoor air,
to be used by the States in preparing programs under subparagraph
(G). The guidelines shall take into account data from existing
radon mitigation programs and the assessment of mitigation
measures prepared under subparagraph (B).
(G) Multimedia radon mitigation programs. -
(i) In general. - A State may develop and submit a multimedia
program to mitigate radon levels in indoor air for approval by
the Administrator under this subparagraph. If, after notice and
the opportunity for public comment, such program is approved by
the Administrator, public water systems in the State may comply
with the alternative maximum contaminant level promulgated
under subparagraph (F) in lieu of the maximum contaminant level
in the national primary drinking water regulation promulgated
under subparagraph (E).
(ii) Elements of programs. - State programs may rely on a
variety of mitigation measures including public education,
testing, training, technical assistance, remediation grant and
loan or incentive programs, or other regulatory or
nonregulatory measures. The effectiveness of elements in State
programs shall be evaluated by the Administrator based on the
assessment prepared by the National Academy of Sciences under
subparagraph (B) and the guidelines published by the
Administrator under subparagraph (F).
(iii) Approval. - The Administrator shall approve a State
program submitted under this paragraph if the health risk
reduction benefits expected to be achieved by the program are
equal to or greater than the health risk reduction benefits
that would be achieved if each public water system in the State
complied with the maximum contaminant level promulgated under
subparagraph (E). The Administrator shall approve or disapprove
a program submitted under this paragraph within 180 days of
receipt. A program that is not disapproved during such period
shall be deemed approved. A program that is disapproved may be
modified to address the objections of the Administrator and be
resubmitted for approval.
(iv) Review. - The Administrator shall periodically, but not
less often than every 5 years, review each multimedia
mitigation program approved under this subparagraph to
determine whether it continues to meet the requirements of
clause (iii) and shall, after written notice to the State and
an opportunity for the State to correct any deficiency in the
program, withdraw approval of programs that no longer comply
with such requirements.
(v) Extension. - If, within 90 days after the promulgation of
an alternative maximum contaminant level under subparagraph
(F), the Governor of a State submits a letter to the
Administrator committing to develop a multimedia mitigation
program under this subparagraph, the effective date of the
national primary drinking water regulation for radon in the
State that would be applicable under paragraph (10) shall be
extended for a period of 18 months.
(vi) Local programs. - In the event that a State chooses not
to submit a multimedia mitigation program for approval under
this subparagraph or has submitted a program that has been
disapproved, any public water system in the State may submit a
program for approval by the Administrator according to the same
criteria, conditions, and approval process that would apply to
a State program. The Administrator shall approve a multimedia
mitigation program if the health risk reduction benefits
expected to be achieved by the program are equal to or greater
than the health risk reduction benefits that would result from
compliance by the public water system with the maximum
contaminant level for radon promulgated under subparagraph (E).
(14) Recycling of filter backwash. - The Administrator shall
promulgate a regulation to govern the recycling of filter backwash
water within the treatment process of a public water system. The
Administrator shall promulgate such regulation not later than 4
years after August 6, 1996, unless such recycling has been
addressed by the Administrator's Enhanced Surface Water Treatment
Rule prior to such date.
(15) Variance technologies. -
(A) In general. - At the same time as the Administrator
promulgates a national primary drinking water regulation for a
contaminant pursuant to this section, the Administrator shall
issue guidance or regulations describing the best treatment
technologies, treatment techniques, or other means (referred to
in this paragraph as "variance technology") for the contaminant
that the Administrator finds, after examination for efficacy
under field conditions and not solely under laboratory
conditions, are available and affordable, as determined by the
Administrator in consultation with the States, for public water
systems of varying size, considering the quality of the source
water to be treated. The Administrator shall identify such
variance technologies for public water systems serving -
(i) a population of 10,000 or fewer but more than 3,300;
(ii) a population of 3,300 or fewer but more than 500; and
(iii) a population of 500 or fewer but more than 25,
if, considering the quality of the source water to be treated, no
treatment technology is listed for public water systems of that
size under paragraph (4)(E). Variance technologies identified by
the Administrator pursuant to this paragraph may not achieve
compliance with the maximum contaminant level or treatment
technique requirement of such regulation, but shall achieve the
maximum reduction or inactivation efficiency that is affordable
considering the size of the system and the quality of the source
water. The guidance or regulations shall not require the use of a
technology from a specific manufacturer or brand.
(B) Limitation. - The Administrator shall not identify any
variance technology under this paragraph, unless the
Administrator has determined, considering the quality of the
source water to be treated and the expected useful life of the
technology, that the variance technology is protective of public
health.
(C) Additional information. - The Administrator shall include
in the guidance or regulations identifying variance technologies
under this paragraph any assumptions supporting the public health
determination referred to in subparagraph (B), where such
assumptions concern the public water system to which the
technology may be applied, or its source waters. The
Administrator shall provide any assumptions used in determining
affordability, taking into consideration the number of persons
served by such systems. The Administrator shall provide as much
reliable information as practicable on performance,
effectiveness, limitations, costs, and other relevant factors
including the applicability of variance technology to waters from
surface and underground sources.
(D) Regulations and guidance. - Not later than 2 years after
August 6, 1996, and after consultation with the States, the
Administrator shall issue guidance or regulations under
subparagraph (A) for each national primary drinking water
regulation promulgated prior to August 6, 1996, for which a
variance may be granted under section 300g-4(e) of this title.
The Administrator may, at any time after a national primary
drinking water regulation has been promulgated, issue guidance or
regulations describing additional variance technologies. The
Administrator shall, not less often than every 7 years, or upon
receipt of a petition supported by substantial information,
review variance technologies identified under this paragraph. The
Administrator shall issue revised guidance or regulations if new
or innovative variance technologies become available that meet
the requirements of this paragraph and achieve an equal or
greater reduction or inactivation efficiency than the variance
technologies previously identified under this subparagraph. No
public water system shall be required to replace a variance
technology during the useful life of the technology for the sole
reason that a more efficient variance technology has been listed
under this subparagraph.
(c) Secondary regulations; publication of proposed regulations;
promulgation; amendments
The Administrator shall publish proposed national secondary
drinking water regulations within 270 days after December 16, 1974.
Within 90 days after publication of any such regulation, he shall
promulgate such regulation with such modifications as he deems
appropriate. Regulations under this subsection may be amended from
time to time.
(d) Regulations; public hearings; administrative consultations
Regulations under this section shall be prescribed in accordance
with section 553 of title 5 (relating to rulemaking), except that
the Administrator shall provide opportunity for public hearing
prior to promulgation of such regulations. In proposing and
promulgating regulations under this section, the Administrator
shall consult with the Secretary and the National Drinking Water
Advisory Council.
(e) Science Advisory Board comments
The Administrator shall request comments from the Science
Advisory Board (established under the Environmental Research,
Development, and Demonstration Act of 1978) prior to proposal of a
maximum contaminant level goal and national primary drinking water
regulation. The Board shall respond, as it deems appropriate,
within the time period applicable for promulgation of the national
primary drinking water standard concerned. This subsection shall,
under no circumstances, be used to delay final promulgation of any
national primary drinking water standard.
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