[Federal Register Volume 66, Number 99 (Tuesday, May 22, 2001)]
[Rules and Regulations]
[Pages 28342-28350]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-12878]
[[Page 28341]]
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Part IV
Environmental Protection Agency
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40 CFR Parts 9, 141, and 142
National Primary Drinking Water Regulations; Arsenic and Clarifications
to Compliance and New Source Contaminants Monitoring: Delay of
Effective Date; Final Rule
Federal Register / Vol. 66, No. 99 / Tuesday, May 22, 2001 / Rules
and Regulations
[[Page 28342]]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Parts 9, 141, and 142
[WH-FRL-6983-8]
RIN 2040-AB75
National Primary Drinking Water Regulations; Arsenic and
Clarifications to Compliance and New Source Contaminants Monitoring:
Delay of Effective Date
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule; delay of effective date.
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SUMMARY: Today's action delays the effective date of the arsenic in
drinking water regulation published on January 22, 2001 (66 FR 6976),
to February 22, 2002. The effective date for the arsenic regulation was
previously delayed 60 days on March 23, 2001 (66 FR 16134), to May 22,
2001. The effective date for clarifications to compliance and new-
source contaminants monitoring in the January 22 arsenic regulation
remains unchanged as January 22, 2004.
On March 20, 2001, EPA's Administrator publicly announced that the
Agency would take steps to reassess the scientific and cost issues
associated with the arsenic rule published on January 22, 2001, and
seek further public input on important issues with that rule. On April
23, 2001, EPA published in the Federal Register (66 FR 20580) a
proposal to delay the effective date of the arsenic rule for an
additional nine months in order to conduct reviews of the science and
costing analysis and make the results available for public review.
Today's action extends the effective date for the arsenic rule from May
22, 2001, to February 22, 2002, in order to conduct the reviews
described in the April 23, 2001 Federal Register (66 FR 20580). For
now, the current standard of 50
g/L remains the applicable arsenic drinking water standard
until the 2006 compliance date for the January 2001 final rule.
DATES: As of May 22, 2001, the effective date of the National Primary
Drinking Water Regulations; Arsenic and Clarifications to Compliance
and New Source Contaminants Monitoring, amending 40 CFR parts 9, 141
and 142, published in the Federal Register on Monday, January 22, 2001,
at 66 FR 6976 and delayed on Friday, March 23, 2001, at 66 FR 16134, is
further delayed for nine months, from the scheduled effective date of
May 22, 2001, to a new effective date of February 22, 2002, except for
the amendments to Secs. 141.23(c)(9), 141.23(i)(1), 141.23(i)(2),
141.24(f)(15), 141.24(f)(22), 141.24(h)(11), 141.24(h)(20), 142.16(e),
142.16(j), and 142.16(k) which are effective on January 22, 2004. The
amendment to Sec. 141.6 in this rule is also effective February 22,
2002.
ADDRESSES: You can review copies of the public comments received on the
proposed nine-month extension of the effective date, EPA responses, and
all other supporting documents in docket W-99-16-IV at the U.S. EPA
Water Docket (4101), East Tower Basement room 57, 401 M Street, SW.,
Washington, DC 20460.
FOR FURTHER INFORMATION CONTACT: The Safe Drinking Water Hotline,
phone: (800) 426-4791 or (703) 285-1093, e-mail: [email protected]
for general information and copies of arsenic documents. For technical
inquiries, contact: James Taft, (202) 260-5519, e-mail:
[email protected]. Contact the Water Docket at (202) 260-3027 to
review the supporting documents and public comments on the proposed
nine-month extension as well as EPA's responses to those comments.
SUPPLEMENTARY INFORMATION: Availability of Docket. For an appointment
to review the docket for this nine-month extension of the effective
date, call 202-260-3027 between 9 a.m. and 3:30 p.m. Eastern Time,
Monday through Friday and refer to Docket W-99-16-IV. Every user is
entitled to 100 free pages, and after that the Docket charges 15 cents
a page. Users are invoiced after they copy $25, which is 267
photocopied pages.
Regulated Entities
A public water system (PWS), as defined in 40 CFR 141.2, provides
water to the public for human consumption through pipes or other
constructed conveyances, if such system has ``at least fifteen service
connections or regularly serves an average of at least twenty-five
individuals daily at least 60 days out of the year.'' A public water
system is either a community water system (CWS) or a non-community
water system (NCWS). A community water system, as defined in
Sec. 141.2, is ``a public water system which serves at least fifteen
service connections used by year-round residents or regularly serves at
least twenty-five year-round residents.'' The definition in Sec. 141.2
for a non-transient non-community water system (NTNCWS) is ``a public
water system that is not a CWS and that regularly serves at least 25 of
the same persons over 6 months per year.'' Entities potentially
regulated by this action are community water systems and non-transient,
non-community water systems. The following table provides examples of
the regulated entities under this rule.
Table of Regulated Entities
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Examples of potentially regulated
Category 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 State, Tribal, or local government-owned/
Government. 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.
------------------------------------------------------------------------
The 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
could potentially be regulated by this action. Other types of entities
not listed in this table could also be regulated. To determine whether
your facility is regulated by this action, you should carefully examine
the applicability criteria in Secs. 141.11 and 141.62 as revised by the
January 22, 2001 (66 FR 6976) arsenic rule.
Abbreviations Used in This Rule
Sec. --section
g/L--micrograms per liter, same as ppb
APA--Administrative Procedure Act
BAT--Best available technologies
CCR--Consumer confidence reports (Subpart O)
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CFR--Code of Federal Regulations
CWS--Community water system
EPA--U.S. Environmental Protection Agency
FACA--Federal Advisory Committee Act
FR--Federal Register
MCL--Maximum Contaminant Level
MCLG--Maximum Contaminant Level Goal
mg/L--milligrams per liter
NAS--National Academy of Sciences, private entity chartered in 1863
to advise the government
NCWS--Non-community water system
NDWAC--National Drinking Water Advisory Council, chartered under
FACA to advise EPA
NPDWR--National primary drinking water regulation
NRC--National Research Council, operating arm of NAS
NTNCWS--Non-transient non-community water system
NTTAA--National Technology Transfer and Advancement Act
OMB--Office of Management and Budget
POTWs--Publicly owned treatment works (treat wastewater)
ppb--parts per billion, same as g/L
PRA--Paperwork Reduction Act
PWS--Public water systems
RFA--Regulatory Flexibility Act
SBREFA--Small Business Regulatory Enforcement Fairness Act
SDWA--Safe Drinking Water Act
TDS--Total dissolved solids
UMRA--Unfunded Mandates Reform Act
U.S.--United States
WHO--World Health Organization
Table of Contents
I. Background and History
A. What is in EPA's January 22, 2001, final rule and what
requirements will be affected by a delay in the effective date?
1. Final arsenic regulations
2. Clarifications for monitoring and compliance for new systems and
new sources
3. Primacy Requirements
4. Changes in consumer confidence reports (CCR) for arsenic
B. What did EPA announce on March 20, 2001?
C. What did EPA propose on April 23, 2001?
D. Why did EPA propose further review of the arsenic rule?
II. What will be the Process for Reviewing the Arsenic Rule?
A. Overview
B. Approach to review of health science
C. Approach to review of cost of compliance estimates
III. Response to Comments
A. Comments specific to the proposal to further delay the
effective date of the January 22, 2001, arsenic rule until February
22, 2002
1. Health concerns
2. Adequacy of existing scientific research
3. Comparison of January 22, 2001 standard to WHO recommended
standard
4. Adequacy of comment period
5. Procedural concerns
6. Review of underlying costs and health effects associated with the
rule
B. Comments not specific to the proposal to further delay the
effective date of the final rule
1. Consumer confidence reports
2. Adverse impacts on small systems
3. Selection and Instruction of the expert panels
4. Use of a sublinear dose response relationship
IV. Administrative Requirements
A. Executive Order 12866, Regulatory Planning and Review
B. Executive Order 13045: Protection of Children from
Environmental Health Risks and Safety Risks
C. Unfunded Mandates Reform Act (UMRA) of 1995
D. Paperwork Reduction Act (PRA)
E. Regulatory Flexibility Act (RFA), as amended by the Small
Business Regulatory Enforcement Fairness Act of 1996 (SBREFA), 5
U.S.C. 601 et. seq.
F. National Technology Transfer and Advancement Act
G. Executive Order 13132, Federalism
H. Executive Order 13175 (Consultation and Coordination with
Indian Tribal Governments)
I. Executive Order 12898: Environmental Justice
J. Congressional Review Act
K. Administrative Procedure Act (APA)
V. References
I. Background and History
A. What is in EPA's January 22, 2001, Final Rule and What Requirements
Will Be Affected by a Delay in the Effective Date?
1. Final Arsenic Regulations
In the Monday, January 22, 2001, Federal Register (EPA 2001a), EPA
issued final regulations for arsenic and clarifications to compliance
and new-source contaminants monitoring (66 FR 6976). The Agency
established a health-based, non-enforceable Maximum Contaminant Level
Goal (MCLG) for arsenic of zero milligrams per liter (mg/L) and an
enforceable Maximum Contaminant Level (MCL) for arsenic of 0.01 mg/L
(i.e., 10 micrograms per liter (g/L)). Until the January 2001
arsenic regulation becomes effective, the existing arsenic regulation
(i.e., no MCLG and an MCL of 50 g/L) issued December 24, 1975
(40 FR 59566) remains in effect. (Although EPA lists drinking water
standards in Title 40 of the Code of Federal Regulations (40 CFR) in
units of mg/L, except where noted, the Agency will refer to arsenic
concentrations in g/L in this preamble.) As part of the
January 2001 arsenic regulation, EPA also listed the approved
analytical methods to measure compliance, the best available
technologies (BAT) and small system technologies that could achieve
compliance with the MCL, and the public reporting requirements (changed
by revising the MCL to 10 g/L). The January 2001 rule
contained an effective date of March 23, 2001, and a compliance date
for this final arsenic regulation of January 22, 2006, five years after
publication for all systems.
2. Clarifications for Monitoring and Compliance for New Systems and New
Sources
On January 22, 2001 (66 FR 6976), EPA also published regulations
for inorganic, volatile organic, and synthetic organic contaminants
(EPA, 2001a), and these regulations are not affected by today's action.
Sections 141.23(i)(1), 141.23(i)(2), 141.24(f)(15), and 141.24(h)(11)
covered the clarifications for monitoring and compliance when a system
fails to collect the required number of samples. Sections 141.23(c)(9),
141.24(f)(22), 141.24(h)(20), and 142.16(k) recognized the State-
specified time period and sampling frequency for new public water
systems and systems using a new source of water for demonstrating
compliance with drinking water regulations.
EPA's review of the arsenic rule does not include a review of the
clarifications to compliance and new source compliance monitoring
regulations issued on January 22, 2001 (66 FR 6976). Therefore, the
``effective date for purposes of compliance'' for these regulations
remains January 22, 2004, as specified in the January 2001 rule in
Sec. 141.6(k).
While provisions of the January 2001 final rule will move arsenic
into the standardized monitoring framework for inorganics (i.e.,
Secs. 141.23(a)(4)(i), (a)(5), (c), (i)(1), (i)(2), and (k)(2),
(k)(3)), the compliance date for the revised arsenic regulations
remains January 23, 2006. Until then, the revisions to Sec. 141.11(a)
and (b) retain the existing monitoring and compliance requirements of
Sec. 141.23(l)--(p) for arsenic.
3. Primacy Requirements
Section 1413(a)(1) of the Safe Drinking Water Act (SDWA), as
amended in 1996, requires States with primary enforcement
responsibility to adopt drinking water regulations that are no less
stringent than EPA's regulations. By statute, States are required to do
so no later than two years after EPA promulgates national primary
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drinking water regulations unless EPA provides up to a two-year
extension. Specifically, States will be required to specify the initial
monitoring requirements for new PWSs and new sources (Sec. 142.16(k))
mentioned in the previous section. In addition, States will have to
adopt the wording for submitting more information for newly regulated
contaminants per Sec. 142.16(e) and less information than now required
for revising primacy for an existing contaminant per Sec. 142.16(j).
EPA is reviewing the final arsenic regulation, and may ultimately
decide to revise the MCL published on January 22, 2001. EPA is also
aware of the practical implications of such possible decisions on State
primacy requirements and State schedules for implementing these
changes. As a result, EPA will be working closely with States in this
regard and will be addressing the issue of State primacy requirements
in more detail in future Federal Register actions.
4. Changes in Consumer Confidence Reports (CCR) for Arsenic
The January 2001 revisions to the CCR rule that included new
reporting requirements for arsenic will be delayed until February 22,
2002. The final rule issued for the consumer confidence rule (63 FR
44512) on August 19, 1998, at Sec. 141.154(b) required CWSs that detect
arsenic between 25 g/L and 50 g/L to include an
informational statement about EPA's review of the arsenic standard
beginning with the report for calendar year 1998 (see Sec. 141.152(a)).
Section 141.153(d)(4) requirements stipulate that if arsenic is
detected, the CCR must list the MCL (i.e., 50 parts per billion (ppb)),
the highest contaminant level used to determine compliance, the range
of detected levels (specified in Sec. 141.153(d)(4)(iv)), and likely
source(s) of contamination. Section 141.153(d)(6) requires that, for
any data indicating violations of the arsenic MCL (i.e., 50 parts per
billion (ppb)), the CCR must explain the length of the violation,
actions taken to address the violation, and the potential adverse
health effects described in appendix A to subpart O.
The final arsenic rule (EPA 2001a) issued on January 22, 2001 (66
FR 6976), made two changes to the annual consumer confidence reports
for arsenic. The January 2001 arsenic rule changed the informational
reporting for arsenic in Sec. 141.154(b) to require additional
information for CWSs that detected between 5 g/L and 10
g/L starting with the calendar year 2001 report (due July 1,
2002). The January 2001 rule (66 FR 6976) also added Sec. 141.154(f) to
require reporting of health effects information for systems that detect
arsenic between 10 g/L and 50 g/L beginning with the
report due July 1, 2002 and ending January 22, 2006, before the new MCL
becomes effective for compliance purposes.
Because of the review of the January 2001 arsenic rule, the
reporting requirements in Secs. 141.154(b) and (f) relating to arsenic
will also need to be reconsidered and may, at the least, need to be
amended to delay the due date for reporting. EPA will be considering
changes to these CCR requirements for arsenic as part of the
forthcoming arsenic rulemaking discussed in section II of today's
preamble.
The effect of today's 9-month delay of the effective date is that,
for the CCR reports for calendar year 2001, CWSs will continue to
implement the CCR requirements for arsenic contained in the August 19,
1998 rule until February 22, 2002, rather than any of the new
requirements of the January 22, 2001 rule.
B. What Did EPA Announce on March 20, 2001?
On March 20, 2001, the Administrator announced plans to seek
independent reviews of the science and cost estimates supporting the
arsenic standard. The March 23, 2001, Federal Register notice (66 FR
16134) delayed the effective date for parts of the arsenic rule by 60
days, from March 23, 2001, to May 22, 2001 (EPA, 2001b). That delay was
in accordance with the memorandum of January 20, 2001, from the
Assistant to the President and White House Chief of Staff, entitled
``Regulatory Review Plan,'' published in the Federal Register on
January 24, 2001 (66 FR 7702).
C. What Did EPA Propose on April 23, 2001?
On April 23 (66 FR 20580), EPA proposed (EPA, 2001c) a further
delay of the effective date for parts of the arsenic rule, until
February 22, 2002, to allow additional time for reconsideration of
specific aspects of the arsenic rule as explained in the next section.
EPA accepted public comments during a 14-day comment period on the
proposed delay of the effective date.
D. Why Did EPA Propose Further Review of the Arsenic Rule?
Consistent with the Administrator's public announcement on March
20, the purpose of proposing a 9-month delay to the effective date was
to allow additional time for review of the science and costing analyses
underlying the arsenic in drinking water rule. EPA understands and
appreciates that the question of setting a final arsenic in drinking
water standard is a controversial one for several reasons. From an
economic standpoint, the new regulation can be expected to have
significant impacts on a number of drinking water utilities, especially
those serving less than 10,000 people in areas of high naturally
occurring arsenic. Stakeholders have an understandable desire to ensure
that any new regulation be based on accurate and reliable compliance
cost and benefit estimates. Stakeholders also want to be confident that
the health risks associated with a new standard have been appropriately
evaluated and are based on the best available science.
II. What Will Be the Process for Reviewing the Arsenic Rule?
A. Overview
EPA considered a number of possible mechanisms for conducting the
necessary reviews of the underlying science and cost of compliance
estimates associated with the arsenic in drinking water rule, and is
also considering establishing a third mechanism to review the benefits
of the rule. The Agency's criteria for conducting the reviews are to
ensure that reviewers are recognized experts in their fields and are as
impartial and objective as possible; that the reviews can be completed
quickly; and that the results of the review be made publicly available
for comment. At present, EPA is using two distinct mechanisms for the
review and will continue to consider other steps to ensure timely and
thorough review of the standard.
Review of Health Effects of Arsenic and Consideration of
Key Issues Associated with the Risk Analysis: National Academy of
Sciences' National Research Council.
Review of Process for Developing Cost of Compliance
Estimates: Specially convened subgroup of the National Drinking Water
Advisory Council.
In the case of the National Research Council, EPA is relying on the
same independent judgment, objective analysis, and scientific expertise
that is reflected in the March 1999 NRC report (NRC, 1999), entitled,
``Arsenic in Drinking Water'' in reviewing the Agency's interpretation
and application of existing arsenic research as well as new studies of
arsenic health effects science that have been published since the 1999
report. With regard to costing issues, the National Drinking Water
Advisory Council has a charter, under the Federal Advisory Committee
Act, to advise the Agency on an array of drinking water issues
associated with
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implementing the national drinking water program and has previously
provided recommendations to the Agency in the development of the
arsenic in drinking water rule.
As its next step in the process for review of the arsenic MCL, EPA
plans to release a proposal requesting comment on a range of arsenic
MCLs from 3 g/L to 20 g/L. The purpose of this
proposal is to provide for additional public comment on the range of
arsenic MCLs and the science, cost and benefit and other analysis
related to the arsenic rule. EPA will also provide the public an
opportunity to comment on the results of the independent science and
cost reviews. EPA then plans to analyze the results of these reviews
together with any public comment on the range of arsenic MCLs to reach
a final decision on how to proceed with regard to the arsenic MCL. As
it becomes available, further information on this process will also be
available on EPA's arsenic in drinking water webpage at www.epa.gov/safewater/arsenic.html and from the Safe Drinking Water Hotline phone:
(800) 426-4791, or (703) 285-1093, e-mail: [email protected].
B. Approach to Review of Health Science
Under a cooperative agreement with EPA, on May 21 the National
Academy of Sciences (NAS) will convene a subcommittee of the National
Research Council's (NRC) Committee on Toxicology to prepare a report
updating the scientific analyses, uncertainties, and findings of the
1999 NRC report ``Arsenic in Drinking Water.'' Specifically, the
subcommittee will review relevant toxicological and health-effects
studies published and data developed since the 1999 NRC report,
including the toxicological risk-related analyses performed by EPA in
support of its regulatory decision-making for arsenic in drinking
water. The subcommittee will address only scientific topics relevant to
toxicological risk and health effects of arsenic.
The subcommittee will meet approximately three times to discuss and
evaluate issues and plans to produce a consensus report in August 2001.
The subcommittee will hear presentations from government agencies,
industry, and other interested or affected parties. Notices of meetings
open to the public are to be posted on the website www.national-academies.org. EPA has asked NRC to make its final report publicly
available, and the report will be available in EPA's arsenic rulemaking
record.
C. Approach to Review of Cost of Compliance Estimates
The National Drinking Water Advisory Council (NDWAC) is chartered
under the Federal Advisory Committee Act (FACA) to advise, consult
with, and make recommendations to EPA. The Agency has asked the NDWAC
to convene a panel of nationally recognized technical experts to review
the cost of compliance estimates associated with the final arsenic
rule. In particular, the working group is to review the costing
methodologies, assumptions, and information underlying the costs
applicable for various categories of water system sizes as well as the
aggregated national estimate of system costs underlying the final
arsenic rule. As a part of this review, the group should evaluate
significant alternative costing approaches or critiques where there is
adequate information upon which to evaluate the basis for such
alternate estimates or approaches.
Working group members will be asked to attend a series of meetings
(approximately three) over the summer of 2001, participate in
discussion of key issues and assumptions at these meetings, and review
work products of the working group. EPA has asked NDWAC to ensure the
working group prepares a report and makes a recommendation to the full
NDWAC based on their review of the national cost estimates. The NDWAC,
in turn, would submit a report and make a recommendation to EPA. All
NDWAC working group meetings and full NDWAC meetings are open to the
public, and meeting information is posted on the calendar accessible
from www.epa.gov/safewater. The report and the final recommendations of
the NDWAC will be made available for public review and comment by EPA
and will also be available in the arsenic rulemaking record.
III. Response to Comments
A. Comments Specific to the Proposal To Further Delay the Effective
Date of the January 22, 2001, Arsenic Rule Until February 22, 2002
The Agency received over 12,000 comments on the April 23, 2001,
proposal to delay the effective date of the January 22, 2001, final
rule (66 FR 6976) another nine months until February 22, 2002, to allow
additional time for reconsideration of the provisions of this final
rule. The majority of the comments came from private citizens sending
electronic mail (i.e., e-mail). Many of these commenters did not
support the extension and cited several reasons for their position:
their concerns about the health hazards posed by arsenic in drinking
water and the consequences of a delayed effective date on
implementation deadlines; their belief that the decade or more of
scientific reviews, public hearings, and other deliberations that
supported the revised arsenic MCL were sufficient and that additional
time is not warranted; and their belief that the standard published on
January 22, 2001, is appropriate and should not be delayed further
since the 10 g/L MCL conforms with the standard set by other
entities, such as the World Health Organization (WHO). A few commenters
believed that the 14-day comment period on the April 23, 2001, proposal
was too short to obtain meaningful comment.
Other commenters, most of whom represented the drinking water
industry, small system water providers, and States, believed that a
short delay to re-examine some of the consequences of the final rule
was warranted, especially to carefully consider the financial impact on
small systems (i.e., systems serving populations of 10,000 or fewer).
These commenters supported a comprehensive and independent review of
the underlying science (health studies used and interpretations of
these studies) and costing associated with the arsenic final rule.
These commenters strongly supported the Agency's plan to use NAS (NRC)
and NDWAC expert panels.
The following sections respond to the comments that were
specifically directed towards the issue of whether or not to delay the
effective date. Section III.B. provides a more general response to the
many issues raised by the commenters that were not directly tied to the
delay of the effective date.
1. Health Concerns
The overwhelming number of commenters expressed concern about a
nine-month delay of the effective date of the revised arsenic rule, due
in part to concerns about immediate health impacts due to a delay in
implementation of the rule. EPA does not believe that this short delay
of the effective date will result in health effects of any kind for
several reasons. First of all, the delay EPA issues today is very
short; EPA has committed to reviewing the science and cost issues
related to the revised final arsenic rule as expeditiously as possible
and no later than early next year. Second, the compliance date for the
revised arsenic rule was five years in the future even under the
January 2001 rule so that there would have been no immediate
implementation of the new standard in
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any case. Moreover, EPA does not anticipate that this short delay will
mean a delay in these compliance deadlines.
2. Adequacy of Existing Scientific Research
Many commenters expressed their belief that extensive research
supports the 10 g/L MCL published in the January 2001 rule and
that there is an insufficient technical and procedural basis for
reconsidering the rule. Many of these commenters urged the Agency to
simply allow the effective date to occur on May 22, 2001, without
impediment. The Agency understands these concerns, but wishes to allow
time for serious reconsideration of the arsenic standard published on
January 22, 2001. A relatively short delay of the effective date
provides flexibility for fully reconsidering the rule and a full range
of options consistent with SDWA section 1412(b)(9) (concerning review
and revisions of existing drinking water regulations). While the Agency
agrees that the January 2001 rule was supported by extensive data and
analysis, the Agency also agrees with other commenters who argued that
this rule is very important and the issues of cost and science that are
central to the rulemaking deserve one final review before concluding
this rulemaking. Thus, EPA believes that the ultimate decision to be
made in early 2002 will be strengthened by allowing additional public
comment and a review by expert panels from NAS and NDWAC. This review
includes a reconsideration of the 3, 5 and 10 g/L MCLs
suggested by the commenters who oppose the extension. The nine-month
period provides a unique opportunity for independent, expert panels to
review the Agency's actions in the final rule in connection with both
the underlying science and the Agency's compliance cost assumptions and
methodologies contained in the final January 2001 rule. This review
also provides an opportunity to examine information that has only
recently become available. In particular, the Agency is aware of many
scientific articles that have become available since the original
report of the NAS (NRC 1999) committee published in March 1999.
3. Comparison of January 22, 2001, Standard to WHO Recommended Standard
Several commenters expressed concerns that the Agency may, as a
result of a nine-month delay of the effective date, revise the January
22, 2001, standard to a less stringent standard that would not comport
with the WHO recommended standard of 10 g/L. In this regard,
the Agency noted in the preamble of the January 2001 final rule (66 FR
7025) that the nonenforceable WHO guideline was not set using the same
health endpoints, feasibility of implementation, or other risk
management factors that are mandated under SDWA. Because the U.S.
drinking water standard for arsenic was not developed using the basis
employed in setting the WHO guideline, the Agency specifically noted in
the 2001 final rule that a possible future change in the WHO value
would not necessarily require a revision to EPA's MCL. For the same
reasons, the Agency's MCL is not dependent on arsenic standards
established by the European Union, or other countries or international
organizations. In any case, the Agency has made no commitment to revise
the standard to a concentration more or less stringent than the January
22, 2001, level.
4. Adequacy of Comment Period
The Agency believes that the fourteen-day comment period was
sufficient to allow public comment on the very narrow issue of whether
or not to provide a short delay of the effective date. Because (1) the
issue is so narrow and the implications so minor in light of the five-
year compliance period and the length of the delay; (2) the rule had
just been issued a few months ago after many months of public input;
(3) there has been intense public attention already devoted to this
rulemaking: and (4) there is an urgency to the upcoming May 22
deadline, the Agency did not feel that it was necessary to have a
longer comment period. Indeed, the number of comments received (over
12,000) greatly exceeded the 1,000 or so comments received on the June
2000 rule that proposed a range of new MCLs for arsenic. The Agency
helped facilitate this strong and diverse response with prior publicity
and a targeted mailing. Prior to publication of the April 23, 2001,
proposal, EPA widely publicized the proposed rule indicating EPA's
intention to seek a delay, and performed a direct mailing to
approximately 1,000 individuals and organizations who had expressed
interest in the arsenic rulemaking.
5. Procedural Concerns
One commenter suggested that the Agency is obliged to provide an
opportunity for a public hearing(s) on the proposed regulation to delay
the effective date, in accordance with section 1412(d) of SDWA before
taking final action on the proposal. Section 1412(d) states that EPA
must provide opportunity for public hearing prior to promulgation of
regulations under section 1412 of SDWA and consult with NDWAC. Today's
action is merely a short delay of the effective date of a recently
published national primary drinking water regulation (NPDWR). As such,
it is, in essence, a continuation of the rulemaking process to revise
the arsenic rule first commenced several years ago. The whole purpose
of this delay is to allow for additional public input and NDWAC
consultation. The Agency does not believe that it is necessary or
appropriate to provide for extensive public comment hearings and
consultations on the issue of whether to have further public debate and
consultation. Indeed, EPA provided several opportunities for public
involvement, including hearings and consulted with NDWAC prior to
issuance of the January 22, 2001, NPDWR and will provide an opportunity
for a public hearing in developing a final decision of whether and how
to revise the January rule, based upon the findings of expert review
panels. As discussed earlier, EPA's review includes working with NDWAC
on some of the most controversial aspects of the January rule. As a
result, while EPA does not believe that it makes sense to hold a public
hearing for today's action, the Agency has fully complied with this
provision throughout this extended rulemaking on arsenic and will
continue to provide public hearing opportunities and hold NDWAC
consultations before taking any action to withdraw, modify or supercede
the January 2001 rule.
Another procedural question raised by some commenters was whether
or not the Agency had met its obligations pursuant to SDWA and Public
Law 106-377 (fiscal year 2001 appropriations act for EPA), requiring
the Agency to promulgate a final rule by June 22, 2001. These
commenters contended that a delay of the effective date would result in
the Agency missing that deadline and urged the Agency to allow the rule
to go into effect on May 22, 2001. The Agency believes that,
independent of the statutory deadline for promulgation, EPA has the
authority to establish appropriate effective dates.
6. Review of Underlying Costs and Health Effects Associated With the
Rule
Several commenters expressed support for delaying the effective
date in order to undertake the necessary scientific and technical
reviews. The Agency agrees with the sentiment that additional time for
technical reviews of elements of the rule is warranted. The Agency also
believes that it is also
[[Page 28347]]
important to recognize that the economic impact of the 80% decrease in
the 50 g/L MCL to 10 g/L affects about 4,000 PWSs,
many of whom serve populations of less than 3,300. Thus, the per capita
cost of the final MCL could be significant at some affected PWSs. The
independent review proposed by EPA provides more time to develop a
mitigation strategy, and the re-opening of the comment period allows
the public to participate in this process and suggest other options.
The Administrator announced her intention to review the cost and
science underlying the rule on March 20, 2001. The delay of the
effective date for parts of the final arsenic rule by nine months will
provide the Agency and the public the benefit of the results of reviews
by independent expert panels and allow for additional comment by
affected individuals and entities. The reviews will be comprehensive
and independent, as suggested by commenters. The results will be a
significant and important source of information for the Agency to
consider as it makes a final decision. There will be no adverse health
impacts resulting from this short delay of the effective date within
the five-year compliance period. For these reasons, the Agency in
today's rule delays the effective date of the January 22, 2001, final
rule until February 22, 2002.
B. Comments Not Specific to the Proposal To Further Delay the Effective
Date of the Final Rule
Some commenters also commented on issues not specific to the April
2001 proposal to delay the effective date of the final arsenic rule by
nine months. Some of these commenters resubmitted or referenced the
same or similar comments that had been submitted in response to the
June 22, 2000, proposed rule. A summary of these extra comments
follows. EPA does not intend to provide a comprehensive response to
these comments because they are not germane to the specific rule issued
today. However, many of these issues will be discussed in an upcoming
proposal as well as in a future notice providing the results of the
reviews of the expert panels referred to earlier.
1. Consumer Confidence Reports
Several commenters disagreed with the consumer confidence reporting
(CCR) rule requirements in the revised arsenic rule. Because of the
high public awareness about arsenic as a potentially toxic contaminant
and carcinogen that may occur in drinking water, the commenters are
concerned that these new requirements will unnecessarily alarm
consumers. The commenters also noted that one of the reporting
requirements is set at 10% of the current 50 g/L MCL. One
commenter believes that the 5 g/L reporting limit is
appropriate, because of the consumer right to know about contamination
of their drinking water.
Based on the recent interest and awareness of the general public
with arsenic in drinking water, the Agency understands that the
requirement for a system to provide health information for arsenic
contamination well below the current MCL of 50 g/L that is in
effect until January 22, 2006, requires further analysis and
discussion. The Agency will study this issue during the nine-month
review of final rule and consider public comment that may be received
during that review. The Agency plans to make a final decision whether
to revise the arsenic CCR requirements as part of its decision making
on whether or not to revise the MCL.
2. Adverse Impacts on Small Systems
Several commenters supporting the delay until February 22, 2002,
also noted that the 2001 final rule requires treatment changes that are
too costly. Commenters were concerned about costs for small systems.
Two commenters also noted that timely compliance with the 2006 date was
in jeopardy, because systems affected by the 10 g/L MCL cannot
begin treatment or other changes until the Agency takes final action on
the results of the review of the final rule.
The Agency appreciates the support for the delay to allow a review
of costs and other issues associated with implementation of the 2001
final rule. The Agency will be further considering concerns raised by
commenters with respect to the issue of how to address the impact of
the nine-month delay on the compliance dates in the final rule. The
statute sets out specific requirements for establishing and extending
compliance dates and EPA will comply with these provisions in
confirming or revising the January 2001 rule.
Many comments on the April 23, 2001, document were limited to a
statement that the costs of the January 2001 rule were too high, or
could not be borne within the 2006 time frame. A few commenters
resubmitted their comments on the June 2000 proposed rule. These
comments on the proposed rule were more detailed and cited specific
issues, such as point-of-use devices, feasibility of treatment in arid
climates, landfill and waste disposal, wastewater treatment burdens on
publicly owned treatment works (POTWs), and impacts of chloride and
total dissolved solids (TDS).
Although the Agency has not yet decided whether or how to change
the provisions of the January 22, 2001, final rule, the issue of the
costs of small system treatment technologies is within the purview of
the forthcoming NDWAC review of the cost models used in the final rule.
Subsequent to additional public comment on this and other issues, and
to the NDWAC expert panel review, the Agency will again address the
issues of costs to small systems.
3. Selection and Instruction of the Expert Panels
Several commenters provided detailed suggestions about how to
select members and charge the expert panels in the review of the
arsenic final rule. Commenters requested that the charge to the panel
be very broad and include all of the issues described in the preamble
of the final rule. The Agency appreciates the suggestions for charging
the expert panels, and is providing the public with several ways to
participate in the review of the final arsenic rule process. For
example, on May 4, 2001 (66 FR 22551), EPA requested nominations of
individuals to serve on the cost working group of NDWAC (EPA, 2001c).
This document provided an opportunity to advise EPA on the selection of
this expert panel. In addition, many of these issues will be discussed
in the future proposed rule that will request comment on a range of
arsenic MCLs and provide for additional public comment on the range of
science and cost issues related to the arsenic rule (66 FR 20582, April
23, 2001). In the April 2001 document, the Agency noted that the
results of the independent science and cost reviews will be made public
along with further information on the review process. Finally, much of
this information will be available on EPA's drinking water webpage at
www.epa.gov/safewater/arsenic.html and from the Safe Drinking Water
Hotline. Similarly, on April 17, 2001, the NAS provided notice about
its charge to the new arsenic committee on its web site and solicited
comment on the provisionally named members of the committee.
The Agency believes there is still a strong basis to specify an
arsenic MCL significantly less than the current 50 g/L
standard. Although the Agency will ask for a review of the 3-20
g/L range proposed in the June 22, 2000, proposed rule, the
public may provide evidence to support a higher drinking water arsenic
standard.
[[Page 28348]]
4. Use of a Sublinear Dose Response Relationship
Some commenters resubmitted their comment on the June 2000 proposal
that the dose-response relationship for arsenic health effects should
use a sublinear model rather than the model used by EPA to specify the
final MCL and MCLG. These commenters believed that a sublinear model
would lead to derivation of a higher MCL and possibly a non-zero MCLG.
Although the Agency has not yet decided whether or how to change
the provisions of the January 22, 2001, final rule, the nonlinear dose
relationship mentioned by commenters is within the purview of the
forthcoming NAS review of the science supporting the final rule.
Subsequent to this expert panel review, and to public comment on this
and other issues, the Agency will determine whether to adopt a
nonlinear dose relationship to calculate an MCLG and MCL for arsenic.
IV. Administrative Requirements
A. Executive Order 12866 Regulatory Planning and Review
Under Executive Order 12866 (58 FR 51735 (October 4, 1993)), the
Agency must determine whether the regulatory action is ``significant''
and therefore subject to OMB review and the requirements of the
Executive Order. The Order defines ``significant regulatory action'' as
one that is likely to result in a rule that may:
(1) Have an annual effect on the economy of $100 million or more or
adversely affect in a material way the economy, a sector of the
economy, productivity, competition, jobs, the environment, public
health or safety, or State, local, or tribal governments or
communities;
(2) Create a serious inconsistency or otherwise interfere with an
action taken or planned by another agency;
(3) Materially alter the budgetary impact of entitlements, grants,
user fees, or loan programs or the rights and obligations of recipients
thereof; or
(4) Raise novel legal or policy issues arising out of legal
mandates, the President's priorities, or the principles set forth in
the Executive Order.
Pursuant to the terms of Executive Order 12866, it has been
determined that this rule is not a ``significant regulatory action,''
and, as such, has not been submitted to OMB for review under the
Executive Order.
B. Executive Order 13045: Protection of Children From Environmental
Health Risks and Safety Risks
Executive Order 13045: ``Protection of Children from Environmental
Health Risks and Safety Risks'' (62 FR 19885, April 23, 1997) applies
to any rule that: (1) Is determined to be ``economically significant''
as defined under Executive Order 12866, and (2) concerns an
environmental health or safety risk that EPA has reason to believe may
have a disproportionate effect on children. If the regulatory action
meets both criteria, the Agency must evaluate the environmental health
or safety effects of the planned rule on children, and explain why the
planned regulation is preferable to other potentially effective and
reasonably feasible alternatives considered by the Agency. This final
rule is not subject to Executive Order 13045 because it is not
economically significant and the Agency does not have reason to believe
that the environmental health risks or safety risks addressed by this
action present a disproportionate risk to children. Nonetheless, EPA
evaluated the environmental health and safety effects of arsenic in
drinking water on children as part of the January 2001 rule and its
proposal.
C. Unfunded Mandates Reform Act (UMRA) of 1995
Title II of the Unfunded Mandates Reform Act of 1995 (UMRA), Public
Law 104-4, establishes requirements for Federal agencies to assess the
effects of their regulatory actions on State, local, and tribal
governments and the private sector. Under section 202 of UMRA, EPA
generally must prepare a written statement, including a cost-benefit
analysis, for proposed and final rules with ``Federal mandates'' that
may result in expenditures to State, Tribal, and local governments, in
the aggregate, or to the private sector, of $100 million or more in any
one year. Before promulgating an EPA rule for which a written statement
is needed, section 205 of UMRA generally requires EPA to identify and
consider a reasonable number of regulatory alternatives and adopt the
least costly, most cost-effective or least burdensome alternative that
achieves the objectives of the rule. The provisions of section 205 do
not apply when they are inconsistent with applicable law. Moreover,
section 205 allows EPA to adopt an alternative other than the least
costly, most cost-effective or least burdensome alternative if the
Administrator publishes with the final rule an explanation why that
alternative was not adopted.
Before EPA establishes any regulatory requirements that may
significantly or uniquely affect small governments, including Tribal
governments, it must have developed under section 203 of the UMRA a
small government agency plan. The plan must provide for notifying
potentially affected small governments, enabling officials of affected
small governments to have meaningful and timely input in the
development of EPA regulatory proposals with significant Federal
intergovernmental mandates, and informing, educating, and advising
small governments on compliance with the regulatory requirements.
Today's rule contains no Federal mandates (under the regulatory
provisions of Title II of the UMRA) for State, local, or tribal
governments or the private sector. This is because the rule imposes no
enforceable duty on any State, local or tribal governments or the
private sector. Thus today's rule is not subject to the requirements of
section 202 and 205 of the UMRA. For the same reason, EPA also has
determined that this action contains no regulatory requirements that
might significantly or uniquely affect small governments. This action
does not impose any requirement on anyone. Thus, there are no costs
associated with this action. Therefore, today's rule is not subject to
the requirements of section 203 of UMRA.
D. Paperwork Reduction Act (PRA)
This action does not impose any new information collection burden
under the provisions of the Paperwork Reduction Act, 44 U.S.C. 3501 et
seq. This action does not impose any requirements on anyone and does
not voluntarily request information. The Office of Management and
Budget (OMB) has previously approved the information collection
requirements contained in the January 22, 2001, regulations, 40 CFR
parts 9, 141 and 142 under the provisions of the Paperwork Reduction
Act, 44 U.S.C. 3501 et seq. and has assigned OMB control number 2040-
0231.
E. Regulatory Flexibility Act (RFA), as Aamended by the Small Business
Regulatory Enforcement Fairness Act of 1996 (SBREFA), 5 U.S.C. 601 et
seq.
The RFA generally requires an agency to prepare a regulatory
flexibility analysis of any rule subject to notice and comment
rulemaking under the Administrative Procedure Act or any other statute
unless the agency certifies that the rule will not have a significant
economic impact on a substantial number of small entities. Small
entities include small businesses, small organizations, and small
governmental jurisdictions.
[[Page 28349]]
The RFA provides default definitions for each type of small entity.
It also authorizes an agency to use alternative definitions for each
category of small entity, ``which are appropriate to the activities of
the agency'' after proposing the alternative definition(s) in the
Federal Register and taking comment. 5 U.S.C. 601(3)-(5). In addition
to the above, to establish an alternative small business definition,
agencies must consult with the Small Business Administration's Chief of
Counsel for Advocacy.
For the purposes of assessing the impacts of today's rule on all
three categories of small entities, EPA considered small entities to be
systems serving 10,000 or fewer customers. In accordance with the RFA
requirements, EPA proposed using this alternative definition for all
three categories of small entities in the Federal Register (63 FR 7605,
February 13, 1998), requested public comment and consulted with SBA
regarding the alternative definition as it relates to small businesses.
In the preamble to the final Consumer Confidence Reports (CCR)
regulation (63 FR 4511, August 19, 1998), EPA stated its intent to
establish this alternative definition for regulatory flexibility
assessments under the RFA for all drinking water regulations and has
thus used it in this proposed rulemaking.
After considering the economic impacts of today's final rule on
small entities, I certify that this action will not have a significant
economic impact on a substantial number of small entities. This action
does not impose any requirements on anyone, including small entities,
it merely extends the effective date of the January 2001 rule.
F. National Technology Transfer and Advancement Act
Section 12(d) of the National Technology Transfer and Advancement
Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272
note) directs EPA to use voluntary consensus standards in its
regulatory activities unless to do so would be inconsistent with
applicable law or otherwise impractical. Voluntary consensus standards
are technical standards (e.g., materials specifications, test methods,
sampling procedures, and business practices) that are developed or
adopted by voluntary consensus standards bodies. The NTTAA directs EPA
to provide Congress, through OMB, explanations when the Agency decides
not to use available and applicable voluntary consensus standards.
This final rulemaking does not impose any new technical standards.
EPA's analysis of the NTTAA's application to the arsenic rulemaking
is described in the June 22, 2000, proposal at 65 FR 38971-38972 and
the January 22, 2001, final rule at 66 FR 7051.
G. Executive Order 13132, Federalism
Executive Order 13132, entitled ``Federalism'' (64 FR 43255, August
10, 1999), requires EPA to develop an accountable process to ensure
``meaningful and timely input by State and local officials in the
development of regulatory policies that have federalism implications.''
``Policies that have federalism implications'' is defined in the
Executive Order to include regulations that have ``substantial direct
effects on the States, on the relationship between the national
government and the States, or on the distribution of power and
responsibilities among the various levels of government.''
This final rule does not have federalism implications. It will not
have substantial direct effects on the States, on the relationship
between the national government and the States, or on the distribution
of power and responsibilities among the various levels of government,
as specified in Executive Order 13132. This rule does not establish or
change any requirements. Thus, Executive Order 13132 does not apply to
this rule.
H. Executive Order 13175 (Consultation and Coordination With Indian
Tribal Governments)
Executive Order 13175, entitled ``Consultation and Coordination
with Indian Tribal Governments'' (65 FR 67249, November 6, 2000),
requires EPA to develop an accountable process to ensure ``meaningful
and timely input by tribal officials in the development of regulatory
policies that have tribal implications.'' ``Policies that have tribal
implications'' is defined in the Executive Order to include regulations
that have ``substantial direct effects on one or more Indian tribes, on
the relationship between the Federal government and the Indian tribes,
or on the distribution of power and responsibilities between the
Federal government and Indian tribes.''
This final rule does not have tribal implications. It will not have
substantial direct effects on tribal governments, on the relationship
between the Federal government and Indian tribes, or on the
distribution of power and responsibilities between the Federal
government and Indian tribes, as specified in Executive Order 13175. As
a result of administrative review of the final regulation published on
January 22, 2001, the Environmental Protection Agency (EPA) is delaying
the effective date for the drinking water regulation for arsenic. The
purpose is to reassess the scientific and cost issues and seek further
public input, as well as to fully review the support available for
small systems. This delay does not impose any burden on tribes or
tribal governments. Thus, Executive Order 13175 does not apply to this
rule.
I. Executive Order 12898: Environmental Justice
Executive Order 12898 establishes a Federal policy for
incorporating environmental justice into Federal agencies' missions by
directing agencies to identify and address disproportionately high and
adverse human health or environmental effects of its programs,
policies, and activities on minority and low-income populations.
Today's action does not establish or change any requirements and
therefore does not have any environmental justice implications.
J. Congressional Review Act
The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. EPA will submit a report containing this rule and other
required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of the rule in the Federal Register. A major rule cannot
take effect until 60 days after it is published in the Federal
Register. This action is not a ``major rule'' as defined by 5 U.S.C.
804(2). This rule will become effective upon publication.
K. Administrative Procedure Act (APA)
Section 553(d) of the Administrative Procedure Act, 5 U.S.C.
553(d), generally requires that a substantive rule not become effective
prior to 30 days after publication. However, that section allows rules
to be effective immediately if the rule relieves a restriction or for
other good cause found by the Agency and published with the rule.
Today's effective date delay is immediately effective. EPA believes
that this action is justified because there is no need to delay the
effective date of a rule that merely delays an effective date. This
rule has little, if any, substantive impact. Thus, EPA believes that
this action is consistent with Section 553 of the APA.
[[Page 28350]]
V. References
NRC. 1999. Arsenic in Drinking Water. Washington, DC. National
Academy Press.
U.S. EPA. 2000. National Primary Drinking Water Regulations;
Arsenic and Clarifications to Compliance and New Source Contaminants
Monitoring; Proposed Rule. Federal Register. Vol. 65, No. 121, p.
38888. June 22, 2000.
U.S. EPA. 2001a. National Primary Drinking Water Regulations;
Arsenic and Clarifications to Compliance and New Source Contaminants
Monitoring; Final Rule. Federal Register. Vol. 66, No. 14, p. 6976.
January 22, 2001.
U.S. EPA. 2001b. National Primary Drinking Water Regulations;
Arsenic and Clarifications to Compliance and New Source Contaminants
Monitoring; Final Rule; Delay of effective Date. Federal Register.
Vol. 66, No. 57, p. 16134. March 23, 2001.
U.S. EPA. 2001c. National Primary Drinking Water Regulations;
Arsenic and Clarifications to Compliance and New Source Contaminants
Monitoring; Notice of Proposed Rulemaking. Federal Register. Vol.
66, No. 78, p. 20580. April 23, 2001.
WH. 2001. Memorandum for the Heads and Acting Heads of Executive
Departments and Agencies. Federal Register. Vo. 66, No. 16, p. 7702.
January 24, 2001.
List of Subjects in 40 CFR Part 141
Environmental protection, Chemicals, Indian lands,
Intergovernmental relations, Radiation protection, Reporting and
recordkeeping requirements, Water supply.
Dated: May 17, 2001.
Christine Todd Whitman,
Administrator.
For the reasons stated in the preamble, the Environmental
Protection Agency takes the following actions:
PARTS 9, 141, AND 142--[DELAY OF EFFECTIVE DATE]
1. To delay the effective date of the amendments to 40 CFR parts 9,
141, and 142 published January 22, 2001 (66 FR 6976), and delayed on
March 23, 2001 (66 FR 16134), from May 22, 2001, to February 22, 2002,
except for the amendments to Secs. 141.23(c)(9), 141.23(i)(1) and
(i)(2), 141.24(f)(15), (f)(22), (h)(11) and (h)(20), and 142.16(e),
(j), and (k), which are effective January 22, 2004.
PART 141--NATIONAL PRIMARY DRINKING WATER REGULATIONS
2. To amend 40 CFR part 141 as follows:
A. The authority citation for part 141 continues to read as
follows:
Authority: 42 U.S.C. 300f, 300g-1, 300g-2, 300g-3, 300g-4, 300g-
5, 300g-6, 300j-4, 300j-9, and 300j-11.
Subpart A--[Amended]
B. Paragraph (j) of 40 CFR 141.6, as added at 66 FR 7061, January
22, 2001, and amended at 66 FR 16134, March 23, 2001, is further
amended by revising the last sentence to read follows:
Sec. 141.6 Effective dates.
* * * * *
(j) * * * However, the consumer confidence rule reporting
requirements relating to arsenic listed in Sec. 141.154(b) and (f) are
effective for the purpose of compliance on February 22, 2002.
* * * * *
[FR Doc. 01-12878 Filed 5-21-01; 8:45 am]
BILLING CODE 6560-50-P