815-Z-01-003
Federal Register/Vol. 66, No. 139/Thursday, July 19, 2001/Proposed Rules
37617
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Parts 141 and 142
[WH-FRL-7015-4J
RIN2040-AB75
National Primary Drinking Water
Regulations; Arsenic and Clarifications
to Compliance and New Source
Contaminants Monitoring
AGENCY: Environmental Protection
Agency (EPA).
ACTION: Notice of proposed rulemaking.
SUMMARY: Today's action proposes and
requests comment on a range of MCL
options for the drinking water standard
for arsenic. In particular, EPA is
requesting comment on whether the
data and technical analyses associated
with the arsenic rule published in the
January 22, 2001, Federal Register (66
FR 6976) as well as any new
information that may be available would
support setting the enforceable arsenic
standard, or Maximum Contaminant
Level (MCL), at 3 micrograms per liter
(Hg/L) (the feasible level), 5 u,g/L (the
level proposed in June 2000), 10 ng/L
(the level published in the January 2001
rule), or 20 u,g/L.
To assist commenters, today's
document provides a brief summary of
the principal data and technical
analyses that accompanied the January
2001 arsenic rule and solicits comment
on key issues associated with this
information and analyses. In providing
comment on these issues, commenters
should focus on the preamble, technical
support documents, and record
associated with the January 2001 rule
(not the June 2000 proposal (65 FR
38888)) because EPA made many
changes to the .analyses supporting the
January decisions in response to public
comment on the June 2000 proposal. In
developing comments, commenters may
also wish to consider information EPA
plans to have in a notice in the fall of
2001, which will request comment on
the results of the additional analyses of
key scientific, technical and economic
elements of the rule. The comment
period for today's notice ends October
31, 2001, because the Agency expects
this comment period to overlap with the
fall 2001 notice's comment period on
the scientific, cost, and benefits reviews.
On May 22, 2001, EPA published in
the Federal Register (66 FR 6976) a final
rule delaying the effective date of the
arsenic rule until February 22, 2002, in
order to conduct reviews of the science
and costing analyses. Additional
information about these reviews as well
as a review of the benefits analysis for
the January 22, 2001, rule are provided
in today's document. EPA expects the
results of these reviews to be available
within the comment period for today's
proposal.
This proposal does not affect the
clarifications to compliance and new
source contaminants monitoring
regulations also issued on January 22,
2001, (66 FR 6976), for inorganic,
volatile organic, and synthetic organic
contaminants. Those regulations go into
effect on January 22, 2004, as provided
in the January 22, 2001, final rule.
DATES: Your comments on a range of
arsenic MCLs from 3 ug/L to 20 ug/L
must be in writing and either
postmarked or received by EPA's Water
Docket by October 31, 2001.
ADDRESSES: You may mail your written
comments to the W—99—16-VI Arsenic
Comments Clerk, Water Docket (MC—
4101); U.S. EPA; 1200 Pennsylvania
Avenue, NW.; Washington, DC 20460.
Comments may be hand delivered (e.g.,
courier or overnight delivery service) to
EPA's Water Docket, located at 401 M
Street, SW.; East Tower BasemenlrRoom
57; in Washington, DC; between 9 a.m.
and 3:30 p.m. Eastern Time, Monday
through Friday. Comments may be
submitted electronically to ow-
docket@epa.gov. See SUPPLEMENTARY
INFORMATION for file formats and other
information about electronic filing and
docket review.
FOR FURTHER INFORMATION CONTACT: The
Safe Drinking Water Hotline, phone:
(800) 426-4791 or (703) 285-1093, e-
mail: hotline-sdwa@epa.gov for general
information, meeting information, and
copies of arsenic regulations and
support documents. For inquiries about
the on-going cost of compliance review,
contact: Mr. Amit Kapadia, (202) 260—
1688, e-mail: kapadia.amit@epa.gov.
For all other questions about this
document, contact Irene Dooley, (202)
260—9531, e-mail: dooley.irene@epa.gov.
SUPPLEMENTARY INFORMATION:
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 § 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 § 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." EPA
has an inventory totaling over 54,000
CWSs and approximately 20,000
NTNCWSs nationwide. Entities
potentially regulated by this action are
CWSs and NTNCWSs. The following
table provides examples of the regulated
entities under this rule.
TABLE OF REGULATED ENTITIES
Category
Industry
State, State,
Tribal, and
Local Gov-
ernment.
Federal Gov-
ernment.
Examples of potentially regu-
lated entities
Privately owned/operated
community water supply
systems using ground
water, surface water, or
mixed ground water and
surface water.
State, Tribal, or local govem-
ment-owned/operated
water supply systems
using ground water, sur-
face water; or mixed
ground water and surface
water.
Federally owned/operated
community water supply
systems using ground
water, surface 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 §§ 141.11 and
141.62 as revised by the January 22,
2001 (66 FR 6976) arsenic rule.
Additional Information for Commenters
No facsimiles (faxes), compressed or
zipped files will be accepted, and
comments must be submitted in writing.
In providing comment on these issues,
commenters should focus on the
preamble, technical support documents,
and record associated with the January
2001 arsenic in drinking water
regulation (not the June 2000 proposal
(65 FR 38888)). EPA addressed
comments prepared for the June 2000
proposed rule in the response-to-
comments document in the docket for
W—99—16—III and summarized responses
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Federal Register/Vol. 66, No. 139/Thursday, July 19, 2001/Proposed Rules
to the major comments in the preamble
of the January 2001 regulation. Please
submit an original and three copies of
your comments and enclosures
(including references) and identify your
submission by the docket number W—
99-16-VI. To ensure that EPA can read,
understand, and therefore properly
respond to comments, the Agency
would prefer that comments cite, where
possible, the question(s) or sections and
page numbers in the document or
supporting documents to which each
comment refers. Commenters should
use a separate paragraph for each issue
discussed. Commenters who want EPA
to acknowledge receipt of their
comments should include a self-
addressed, stamped envelope.
EPA uses WordPerfect as its standard
software, so electronic submissions
(including 3.5 inch floppy disks) must
be submitted in WordPerfect 8 (or older
version) or ASCII file format (unless
four hard copies are also submitted).
Comments submitted in other electronic
formats (e.g.. Word, pdf, Excel, and
compressed or zipped files) must also be
submitted as hard copies. For purposes
of dating dual hard copy/electronic
copy submissions, the date of the
electronic copy will be recorded as the
date submitted. Please indicate that you
are sending hard copies so the Docket
can link your two submissions rather
than log in two sets of your comments.
Electronic comments on this document
may be Died online at many Federal
Depository Libraries.
The Agency's response-to-comments
document for W-99-16-VI will address
the comments received for this
proposal, and this document will be
made available in the docket. Since the
comment period ends October 31, 2001,
the response-to-comment document will
not be completed until sometime later
in the fall of 2001. To facilitate
development of a response-to-comments
document, EPA appreciates receiving an
electronic version in addition to the
original and three copies for large
submissions (e.g., over 10 pages). The
Agency does not send out individual
replies to respond to those who submit
comments.
Availability of Docket
For an appointment to review the
docket for this rulemaking, 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-VI. Every
user is entitled to 100 free pages, and
after that the Docket charges 15 cents a
page. Users are invoiced after they copy
S25, which is 267 photocopied pages.
The Safe Drinking Water Hotline can
provide some hard copies of some of the
supporting documentation and some
electronically, phone: (800) 426-4791 or
(703) 285-1093, e-mail: hotline-
sdwa@epa.gov. EPA's arsenic-in-
drinking-water web page contains links
to the arsenic Federal Register notices
and other supporting material at
www.epa.gov/safewater/arsenic.html.
Abbreviations Used in This Proposed Rule
>—greater than
<—less than
§—section
Hg—micrograms, one millionth of a gram (3.5
X 10~8 ounce, 0.000000035 oz.)
Hg/L—micrograms per liter, same as parts per
billion (ppb)
AES—Atomic emission spectroscopy
ARBRP—-Arsenic Rule Benefits Review Panel
of SAB
AWWARF—American Water Works
Association Research Foundation
BAT—Best available technology
CCR—Consumer Confidence Report
CFR—Code of Federal Regulations
CWS—Community water system
DWSRF—Drinking Water State Revolving
Fund
EA—Economic analysis
EO—Executive Order
EPA—U.S. Environmental Protection Agency
ERDDAA—Environmental Research,
Development, and Demonstration
Authorization Act, SAB
FACA—Federal Advisory Committee Act
FR—Federal Register
FRFA—Final regulatory flexibility analysis
FSIS—Federalism summary impact statement
GW—Ground water
ICP—Inductively coupled plasma
ICR—Information Collection Request
ISCV—Intra-system coefficient of variation
IRFA—Initial regulatory flexibility analysis
ISCV—Intra-systein coefficients of variation
L—Liter, also referred to as lower case "1" in
older citations
MCL—Maximum contaminant level
MCLG—Maximum contaminant level goal
nig—milligrams, one thousandth of a gram, 1
mg= l.OOOjig
mg/L—milligrams per liter
NAS—National Academy of Sciences
NCWS—Non-community water system
NDWAC—National Drinking Water Advisory
Council, EPA FACA group
NOD A—Notice of Data Availability
NPDWR—National primary drinking water
regulation
NRC—National Research Council, the
operating arm of NAS
NTNCWS—Non-transient non-community
water system
NTTAA—National Technology Transfer and
Advancement Act
OMB—Office of Management and Budget
P.L.—Public Law
PNR—Public Notification Rule
POTW—Publicly owned treatment works,
wastewater treatment
POU—Point-of-use treatment devices
PRA—Paperwork Reduction Act
PWS—Public water systems
REF—Relative exposure factors
RFA—Regulatory Flexibility Act
RUS—Rural Utilities Service
SAB—Science Advisory Board
SBA—Small Business Administration
SBAR—Small Business Advocacy Review
SBREFA—Small Business Regulatory
Enforcement Fairness Act
SDWA—Safe Drinking Water Act
SW—Surface water
UMRA—Unfunded Mandates Reform Act
U.S.—United States
USGS—U.S. Geological Survey
VSL—Value of statistical life
WTP—Willingness to pay
Table of Con tents
I. Background and History Preceding This
Document
A. What is in the arsenic rule published on
January 22, 2001?
1. Summary of arsenic regulation
2. Changes to the Consumer Confidence
Report (CCR) for arsenic
3. Changes to public notification for
arsenic
4. Arsenic rule's effect on State/Tribal
primacy programs
B. What did EPA's Administrator
announce on March 20, 2001?
C. How has the effective date of the arsenic
rule changed?
1. March 23, 2001 Federal Register 60-day
delay notice
2. April 23, 2001 Federal Register 9-month
extension proposal
3. May 22, 2001 Federal Register February
22, 2002 effective date
4. Effect on CCR for calendar year 2001
D. With what regulatory standard for
arsenic must systems comply now?
II. EPA's Plans to Review Parts of the Arsenic
Rule
A. What is the purpose of today's action
and what happens now?
B. What approach will EPA use to review
the science, costs, and benefits of the
rale?
1. Overview
2. Approach to review of health science
3. Approach to review of cost of '
compliance estimates
4. Approach to review of benefits estimates
C. How did EPA assess the occurrence of
arsenic?
1. Summary of arsenic occurrence analysis
2. Request for occurrence comments
D. How did EPA evaluate the health risks
of arsenic in drinking water?
1. Summary of health risk elements
2. Request for comment on health issues
E. How did EPA calculate the national
costs of compliance with the arsenic in
drinking water rule?
1. Summary of cost elements of January 22,
2001 rule and record
2. List of cost issues and request for
comments
F. How did EPA calculate the benefits of
the arsenic rule?
1. Summary of the January 22, 2001,
benefits assessment
2. List of key benefit analysis issues
a. Discounting benefits over a cancer
latency period
b. Consideration of non-quantifiable
benefits in the regulatory decision-
making process
3. Request for comments on benefits
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37619
G. What process is EPA planning for
review of financial, technical, and
planning tools for small systems?
1. Small system review process
2. List of small system issues
a. Affordability, availability of financial
assistance, and treatment technology
b. SDWA Capacity Development
Framework
3. Request for small systems comment
III. Process to be Employed after Technical
Reviews and Public Comment
A. How will EPA notify the public of
results of the technical reviews and the
nature of the public comments?
B. What process will EPA use to make final
decisions on the rule?
IV. Administrative Requirements
A. Executive Order 12866, Regulatory
Planning and Review
B. Regulatory Flexibility Act (RFA), as
amended by the Small Business
Regulatory Enforcement Fairness Act of
1996 (SBREFA), 5 U.S.C. 601 et seq.
C. Unfunded Mandates Reform Act
(UMRA) of 1995
D. Paperwork Reduction Act (PRA)
E. National Technology Transfer and
Advancement Act
F. Executive Order 12898: Environmental
Justice
G. Executive Order 13045: Protection of
Children from Environmental Health
Risks and Safety Risks
H. Executive Order 13132, Federalism
I. Executive Order 13175, Consultation and
Coordination with Indian Tribal
Governments
J. Consultations with the Science Advisory
Board, National Drinking Water
Advisory Council, and the Secretary of
Health and Human Services
K. Likely Effect of Compliance With the
Arsenic Rule oh the Technical,
Financial, and Managerial Capacity of
Public Water Systems
L. Executive Order 13211, Actions
Concerning Regulations That
Significantly Affect Energy Supply,
Distribution, or Use
V. References
I. Background and History Preceding
This Document
''A. What Is in the Arsenic Rule
Published on January 22, 2001?
1. Summary of Arsenic Regulation
In the Monday, January 22, 2001,
Federal Register (EPA 2001a), EPA
issued regulations revising the arsenic
drinking water standard and clarifying
compliance and new-source
contaminants monitoring provisions (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) in § 141.15(b) and an
enforceable Maximum Contaminant
Level (MCL) for arsenic of 0.01 mg/L
(i.e., 10 micrograms per liter ((ig/L)} for
both community water systems (CWSs)
and non-transient non-community water
systems (NTNCWSs) in § 141.62{b)(16).
(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
ug/L in this preamble.) As part of the
arsenic regulation, EPA also listed the
approved analytical methods to measure
compliance (§ 141.23(k)(l)), as well as
the best available technologies (BAT)
(§ 141.62(b)), small system technologies
that could achieve compliance with the
MCL (§ 141.62(d)), consumer confidence
report requirements for CWSs, and
public notification requirements for
PWSs for the new MCL. Because the
Agency identified affordable
technologies for small systems, the rule
did not list any small system variance
technologies under § 1412{b)(15)(A) of
the Safe Drinking Water Act (SDWA).
All but one of the five existing arsenic
analytical technologies can be used for
compliance determinations. As noted in
the June 2000 proposal (65 FR 38888 at
38913) and January 2001 rule (66 FR
6976 at 6988), inductively coupled
plasma (ICP)—atomic emission
spectroscopy (AES) methods in EPA
Method 200.7 and Standard Methods
312 0 B have unacceptably high
detection limits (see footnote 15 to table
in § 141.23(k)(l); 66 FR 6976 at 7062).
EPA established an effective date of
March 23, 2001, and a compliance date
(§ 141.6(j)) for the arsenic regulation of
January 23, 2006, five years after
issuance for all systems. However, the
consumer confidence reporting
requirements for arsenic listed in
§ 141.6(j) had a March 23, 2001
compliance date.
EPA intended to issue a small entity
implementation or compliance guide
shortly after issuing the rule (66 FR
6976 at 7033). However, because of the
on-going reviews, the Agency believes
that it is premature to distribute small
entity guidance at this time.
2. Changes to the Consumer Confidence
Report (CCR) for Arsenic
On August 19, 1998, EPA issued part
141 subpart O, the final rule requiring
community water systems to provide
annual water quality report to their
customers (63 FR 44512; EPA, 1998a).
Reports are now due by July 1 for the
preceding calendar year (§ 141.152(a)).
Any time arsenic is detected, the report
must list the MCL (50 ug/L), the MCLG
(none), and the highest level used to
determine compliance and the range of
detected levels, according to
§§141.153(d)(4)(i), (ii), and (iv),
respectively. Section 141.153(d)(6)
requires the CCR to identify MCL
. violations, steps taken to address
violations, and potential health effects
using the language in appendix A of
subpart O. In addition, using the
authority of section 1414(c)(4)(B)(vi) of
SDWA (63 FR 44512 at 44514), systems
that detect arsenic between 25 ug/L and
50 fig/L are also required to provide an
informational statement (§ 141.154(b)).
As published, the arsenic rule would
make two reporting changes for systems
detecting arsenic below 50 ug/L that
would affect the CCR due by July 1,
2002, for calendar year 2001 (66 FR
6976 at 6991). First, CWSs would be
required to include a revised
informational statement (§ 141.154(b))
about arsenic when detected from 5 ug/
L.to 10 ug/L. In the arsenic rule; the
Agency retained § 141.154(b) reporting
requirements because the MCL is higher
than the technologically feasible MCL
(66 FR 6976 at 6991). Second, as
proposed in § 141.154(b) and finalized
in § 141.154(f), systems detecting from
10 ug/L to 50 ug/L would also provide
the arsenic health language in appendix
A to subpart O (§ 141.154(fJ), even
though systems are in compliance with
the 50 Ug/L MCL through January 22,
2006. (January 23, 2006, is the effective
date for the MCL of 10 ug/L
(§ 141.60(b)(4)).) As explained in section
I.C.4, the current 9-month extension of
the effective date until February 22,
2002, affects the CCR requirements of
the January 2001 rule for calendar year
2001 reports.
3. Changes to Public Notification for
Arsenic
On May 4, 2000, EPA issued the final
Public Notification Rule (PNR) to revise
the minimum requirements that public
water systems must meet for public
notification of violations of EPA's
drinking water standards (65 FR 25982;
EPA, 2000b). Systems must begin to
comply with the revised PNR
regulations on October 31, 2000 (if they
are in jurisdictions where the program
is directly implemented by EPA, such as
Wyoming and many Tribes), or on the
date that a primacy State/Tribe adopts
the new requirements (no later than
May 6, 2002).
The January 2001 arsenic rule would
require CWSs and NTNCWSs to provide
a Tier 2 public notice for arsenic MCL
violations (> 10 ug/L) and to provide a
Tier 3 public notice for violations of the
monitoring and testing procedure
requirements. In addition, public water
systems must give notice for all
violations when operating under a
variance or exemption and for violating
conditions of the variance or exemption.
The arsenic regulation (66 FR 6976)
amended the PNR, subpart Q of part
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141, for purposes of compliance starting
January 23, 2006 (§ 141.6(j); 66 FR 6976
at 7061).
4. Arsenic Rule's Effect on State/Tribal
Primacy Programs
States must submit applications for
revised primacy no later than 2 years
after promulgation of a new standard
unless the State requests and is granted
an additional 2-year extension. Interim
primacy enforcement authority
(§ 142.12(e)) allows States to implement
and enforce drinking water regulations
once State regulations are effective and
the State has submitted a complete and
final primacy revision application.
In the arsenic rule, EPA reduced
requirements for submitting revisions
for existing regulated contaminants
(§§ 142.16(e) and (j)), so that
information required in § 142.16(e) is
not required for States revising the MCL
for arsenic. In addition, revisions to
§ 142.16Q) clarified that States may
inform the Agency in their applications
of any changes to their existing
monitoring plans and waiver
procedures. These regulations are
effective for purpose of compliance on
January 22, 2004 (§ 141.600; 66 FR 6976
at 7061).
Currently, the Navajo Nation is the
only federally recognized Indian Tribe
with primacy to enforce drinking water
regulations. EPA Regions implement the
rules for all other Tribes under section
1451(a)(l) of SDWA. Tribes must submit
a primacy application (§ 142.76) to have
oversight for the inorganic contaminants
(i.e., the Phase n/V rule) to obtain the
authority for the revised arsenic MCL.
Tribes with primacy for drinking water
programs are eligible for grants and
contract assistance (section!451(a)(3) of
SDWA). Tribes are also eligible for
grants under the Drinking Water State
Revolving Fund Tribal set-aside grant
program authorized by section 1452(i) of
SDWA for public water system
expenditures.
. EPA is aware of the practical
implications of the ongoing reviews and
delayed effective date on States and
Tribes in terms of primacy and other
requirements. EPA will consult with
States and interested Tribes before
addressing the effects on State primacy
in future Federal Register notices.
B. What Did EPA's Administrator
Announce on March 20,2001?
On March 20, 2001, the Administrator
announced in a press release that EPA
xvould delay the effective date for the
arsenic rule 60 days. That extension was
in accordance with the White House
(WH) memorandum of January 20, 2001,
entitled "Regulatory Review Plan,"
which was published in the Federal
Register (WH 2001) on January 24, 2001
(66 FR 7702). The January 20, 2001,
memorandum from Andrew Card,
Assistant to the President and Chief of
Staff, communicated the President's
plan to ensure that his appointees had
•the opportunity to review new
regulations "at the outset of his
Administration" in order to avoid
"costly, burdensome, or unnecessary
regulation* * *." For regulations that
had been published in the Federal
Register, but were not yet in effect, the
memorandum requested departments
and agencies to postpone their effective
dates for 60 days. In order to provide
safe and affordable drinking water, the
Administrator announced plans to seek
independent reviews of the science
behind the arsenic standard and the cost
estimates used to develop the rule.
C. How Has the Effective Date of the
Arsenic Rule Changed?
1. March 23, 2001 Federal Register 60-
Day Delay Notice
On March 23, 2001 (EPA 2001b), the
Federal Register published EPA's 60-
day delay of the effective date for the
arsenic regulation (66 FR 16134), in
accordance with the White House
memorandum, "Regulatory Review
Plan" (66 FR 7702). The delay changed
the effective date for the arsenic
regulation from March 23, 2001, to May
22, 2001, including the dates for
compliance with the consumer
confidence reporting requirements for
§ 141.154(b) and (f) that were
specifically linked to the new arsenic
regulation.
2. April 23, 2001 Federal Register 9-
Month Extension Proposal
On April 23, 2001 (EPA 2001c), EPA
proposed (66 FR 20580) to extend the
effective date for the arsenic rule from
May 22, 2001, to February 22, 2002, in
order to obtain independent reviews of
the science, cost, and benefit analyses
used to support the arsenic in drinking
•water regulation. The notice outlined
the process for the science and cost
reviews,.
3. May 22, 2001 Federal Register
February 22, 2002 Effective Date
After reviewing the comments
received on the 9-month proposed delay
of the effective date, the Agency issued
a final rule (EPA 2001f) on May 22, 2001
(66 FR 28342), delaying the final
effective date until February 22, 2001,
so the Agency could proceed as planned
with the proposed reviews and
opportunities for additional public
comment. EPA identified mechanisms
for reviewing the science and cost
estimates in the notice and provided
responses to comments in the preamble
(66 FR 28342 at 28345) that are in the
response-to-comment document for
docket W-99-16-IV (EPA 2001).
4. Effect on CCR for Calendar Year 2001
The final rule for the 9-month delay
(66 FR 28342 at 28350) also changed the
§ 141.6(j) compliance date to February
22, 2002, for the new arsenic consumer
confidence reporting requirements in
§§ 141.165(b) and (f). The delay will
affect some systems that send out
calendar year 2001 reports. CWSs that
send out calendar year 2001 reports
prior to February 22, 2002 must comply
with the old arsenic CCR requirements
(those in effect prior to the January 2001
rule). CWSs that send their reports after
February 22, 2002, will have to comply
with the new arsenic CCR requirements.
In light of the current analyses being
conducted on aspects of the arsenic
rule, the Agency plans to address CCR
reporting issues and options in the fall
2001 notice.
D. With What Regulatory Standard for
Arsenic Must Systems Comply Now?
In the process of extending the
effective date for the arsenic rule, EPA
has not changed the compliance date for
the MCL issued in the January 2001
rule. Until January 23, 2006, the MCL
for arsenic is 50 flg/L, which only
applies to CWSs (§§ I41.11(a) and (b)),
and there is no MCLG for arsenic
II. EPA's Plans to Review Parts of the
Arsenic Rule
A. What Is the Purpose of Today's
Action and What Happens Now?
The January 22, 2001, rule established
an MCLG of 0 ng/L and an MCL of 10
p.g/L for arsenic and explained in detail
the rationale for this decision. However,
because of concerns raised by some
stakeholders concerning the arsenic in
drinking water regulation,. especially
small community systems that may bear
a high cost burden to comply with the
new standard, EPA has decided to
request further comment on the arsenic
standard set in the January 22, 2001,
drinking water rule.
As a result, today EPA proposes and
requests stakeholder input on a range of
MCL options for arsenic from 3 |ig/L to
20 (ig/L. In developing comments,
commenters should refer to the
information provided in the January 22,
2001, arsenic rule, the background
documents supporting that rule, the
notice and request for comment on the
scientific, technical, and benefits
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reviews that EPA plans to publish in the
fall of 2001, and any new (post-January
2001) information commenters wish to
provide. EPA is accepting comments
until October'31, 2001, on today's notice
to facilitate commenters' ability to
examine the most current information.
The Agency also anticipates that the
comment period for the notice
summarizing the fall 2001 reviews will
overlap with today's comment period,
thereby allowing commenters to provide
a single set of comments covering both
today's notice and the expected fall
2001 notice, if they wish.
EPA is also undertaking additional
analyses on science, cost, and benefits
issues, as explained in section II.B., and
expects these analyses to be completed
in August 2001. Once the analyses are
completed, EPA will consider this new
information and provide for an
additional opportunity for public
comment on the new analyses along
with EPA's preliminary conclusion
about whether the January 2001 arsenic
rule should be revised, and if so, what
the revised standard should be. EPA
will consider the public comments, as
well as the record for the arsenic rule for
this reconsideration, and issue a final
decision on whether to revise the
January 2001 rule. In particular, EPA is
considering whether to retain the
revised MCL of 10 ug/L or replace it
with another standard—specifically, 3
ug/L (the feasible level), 5 ug/L (the
level proposed in June 2000) or 20 ug/
L (another alternative considered in the
June 2000 proposal). If EPA does decide
to revise the January 2001 rule, EPA will
issue a new revised rule.
B. What Approach Will EPA Use To
Review the Science, Costs, and Benefits
of the Rule?
1. Overview
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 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.
The Agency is committed to safe and
affordable drinking water for all
Americans.- At the same time, we want
to be sure that the conclusions about
arsenic in the rule are supported by the
best available science and policy
decisions based on thorough cost-
benefit considerations. The Agency is
therefore moving rapidly to review
arsenic research and national cost and
benefit estimates related to the arsenic
standard so that communities that need
to reduce arsenic in drinking water can
proceed with confidence that the new
standard is based on sound science and
accurate cost-benefit estimates.
Independent review of the science, cost,
and benefits analysis behind the arsenic
in drinking water standard will help
resolve questions that have arisen about
the health basis and costs and benefits
of reducing arsenic in drinking water.
EPA's criteria for conducting the
reviews will be to ensure that reviewers
are recognized experts in their fields
and are as impartial and objective as
possible; that the reviews can be
completed in August 2001; and that the
results of the reviews are made available
for public comment. EPA plans to
utilize the mechanisms for the reviews
described in the following section.
EPA does not plan to seek outside,
expert review of its approaches for
estimating occurrence or determining
the availability of analytical methods
and their capabilities but is requesting
further public comment on these aspects
of the January 2001 rule.
2. Approach to Review of Health
Science
Under a cooperative agreement with
EPA, on May 21 the National Academy
of Sciences (NAS) convened a
subcommittee of the National Research
Council's (NRC) Committee on
Toxicology to prepare a report updating
the scientific analyses, uncertainties,
findings and recommendations of the
report "Arsenic in Drinking Water (NRC
1999)." NAS posts information about
the arsenic study, including project
scope, the subcommittee membership
and biographies, meetings, and meeting
summaries of the closed sessions (NRC
2001a and NRC 2001b) in the website
www.nationalacademies.org under
Current Projects (the short cut to the
direct NRC arsenic project address,
www4.nas.edu/cp.nsf/
Of89ea56d4264b948525639b0043e7c7/
7ae42f9d0397214b85256a310071 Ifl 5?
OpenDocument, is available from
www.epa.gov/safewater/ arsenic.html].
Information on NRC's committee
process is also available on the NAS
website under Frequently Asked
Questions at
www.nqtionalacademies.org/ about/
faq4.html. Specifically, the
subcommittee is reviewing 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 and the health effects
discussion in EPA's SAB December
2000 report entitled, "Arsenic Proposed
Drinking Water Regulation: A Science
Advisory Board Review of Certain
Elements of the Proposal (EPA 2000f)."
The subcommittee is addressing 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 will produce a
consensus report in August 2001. On
May 21, the NRC subcommittee heard
presentations from EPA, the Small
Business Administration, a consultant
for Albuquerque, researchers, industry,
environmental and other interested or
affected parties. At the open session
meeting on June 20, the committee
heard from EPA's Administrator. The
draft consensus report will undergo the
established NRC peer review process
before NRC issues the final report that
is available to the public. In addition,
EPA will make the NRC's report
available to the general public and
request comment on its
recommendations as part of a notice this
fall.
3. 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 asked the NDWAC, and the
Council agreed to convene a panel of
nationally recognized technical experts
to review the cost of compliance
estimates associated with the regulatory
options that were considered in the
proposed rule and discussed in the
January 2001 rule. On May 4, 2001 (EPA
200ld), EPA requested nominations for
the working group (66 FR 22551). In
particular, the working group is
reviewing the costing methodologies,
assumptions, and information
underlying the system-size as well as
the aggregated national estimate of
system costs underlying the January
2001 arsenic in drinking water rule. As
a part of this review, the group is
evaluating significant alternative costing
approaches or critiques where there is
adequate information upon which to
evaluate the basis for such alternate
estimates or approaches.
The working group first met May 29—
30, 2001, as announced in the May 22,
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2001, Federal Register (EPA 2001f).
Working group members have been
asked to attend a series of meetings
(June 28-29 in Denver, Colorado; July
9-10 in Phoenix, Arizona; and July 19-
20 in Washington, DC) over the summer
of 2001 (June 15, 2001 Federal Register,
EPA 2001h), participate in discussion of
key issues and assumptions at these
meetings, and review work products of
the working group. The working group
will make a recommendation to the full
NDWAC based on its review of the
national cost estimates. The NDWAC,
will in turn, 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/sa/ewater.
EPA posts the working group member
list and meeting summaries athttp://
\v\v\v.epa.gov/safewater/nd\vac/
council'Jitml. The report of the working
group and the final recommendations of
the NDWAC will be made available for
public review and comment.
4. Approach To Review of Benefits
Estimates
The EPA Science Advisory Board
(SAB), which also is chartered under the
FACA, was established in 1978 by the
Environmental Research, Development,
and Demonstration Authorization Act
(ERDDAA) (42 U.S.C. 4365), to provide
such scientific advice as may be
requested by the Administrator. At the
request of the Agency the SAB has
convened a panel, the Arsenic Rule
Benefits Review Panel (ARBRP), to
review the Agency's'analysis of
quantified and unqualified benefits
associated with the arsenic drinking
xvater rule. The Agency has asked this
panel of nationally recognized technical
experts to review the Agency's analysis
of quantified and unquantified arsenic
benefits analysis as required by SDWA,
and evaluate whether the components,
methodology, criteria and estimates
reflected in EPA's benefits analysis are
reasonable and appropriate in light of:
(1) The SAB's benefits transfer report
(EPA 2000d; available on the SAB
Website at ivivw.epa.gov/sa6/
eeacf013.pdf); (2) EPA's Guidelines for
Preparing Economic Analyses (EPA
20001; mviv.epa.gov/econprn/cs); (3)
relevant requirements of.the Safe
Drinking Water Act (SDWA;
inviv.epa.gov/sa/eivafer/sdwa/
sdwa.html); (4) NDWAC
recommendations to EPA on benefits
(unpublished October 29,1998, Benefits
Working Group Report to the National
Drinking Water Advisory Council; EPA
1998b); and (5) recent literature.
Panel members have been asked to
attend one or more meetings over the
summer of 2001, participate in
discussion of key issues and
assumptions at these meetings, and
review the previously described
documents and literature. The first
meeting of the ARBRP will be on July
19-20, in Washington, D.C. (EPA 2001i).
To ensure that the SAB's
recommendations are fully considered
in decision making, the Agency has
asked for a report to be made available
to the Administrator in August 2001 to
coincide with the findings and
recommendations from independent
reviews of the health effects by NRG and
costs by NDWAC. All ARBRP meetings
are open to the public and time will be
allotted for presentations by the public.
Meeting information is posted on the
calendar accessible from MTVW.epa.gov/
safewater. The report of the ARBRP and
the final recommendations of the SAB
•will be made available for public review
and comment.
C. How Did EPA Assess the Occurrence
of Arsenic?
1. Summary of Arsenic Occurrence
Analysis
EPA's occurrence estimates were a
fundamental building block in cost of
compliance estimates as well as its
benefits estimates. To develop this
occurrence estimate, EPA used arsenic
compliance monitoring data consisting
of almost 77,000 observations from 25
States to estimate the distribution of
arsenic in finished drinking water in
public water systems (PWS) in the U.S.
These States voluntarily submitted the
data from public water systems. Figure
V-l in the June 2000 proposed rule (65
FR 38888 at 38906) is a map of the 25
States from which EPA used data to
estimate occurrence. These States are
distributed throughout the U.S., with at
least one located in each of the seven
geographic regions that the Agency used
in its analysis (EPA 2000h). Ten other
States (Florida, Idaho, Iowa, Louisiana,
Pennsylvania, South Dakota, Maryland,
Nebraska, Vermont, and West Virginia)
submitted compliance monitoring data,
but those data were not complete
enough to estimate State occurrence (66
FR 6976 at 7029). EPA lists the database
parameters used to derive its national
occurrence estimate in Appendix D-2 of
the occurrence document (EPA 2000h).
In order to estimate a national
occurrence distribution of arsenic, EPA
began with individual water systems
and built up estimates for States,
regions, and the nation. For each PWS
in its database, the Agency estimated
the mean arsenic concentration over
time in finished water. (Although MCL
compliance is determined by computing
a running annual average of quarterly
samples, EPA elected to characterize
arsenic occurrence in each system in
terms of the mean arsenic concentration
over time, rather than by a set of
running averages; for the benefits
estimates, the long-term mean is
preferable, because health risks are
determined by mean exposure to arsenic
over time; for the cost estimates, the
approach used may not accurately
predict costs in all cases, since some
systems with a long-term average below
the standard might still exceed it during
some compliance cycles.) Next* the
Agency collected the system mean
estimates into State distributions, then
merged the State distributions into
regional and finally, national
distributions. The regions used in the
analysis are shown in Figure V—1 in the
June 2000 proposed rule (65 FR 38888
at 38906). In combining the regional
distributions into a national
distribution, the Agency weighted each
region by the;total number of systems in
the region, not just the number of
systems in the States in its database.
This procedure has the same effect as
assigning the regional distributions to
the 25 States for which there are no
observations in the database.,
EPA estimated separate arsenic
occurrence distributions for community
water systems (CWS) and non-transient,
non-community water systems
(NTNCWS), and for systems with
ground water (GW) and surface water
(SW) sources. Systems identified as
having ground water under the
influence of surface water were treated
as surface water systems. Table III.C-1
(66 FR 6976 at 6996) shows the Agency
had data from 17 States for ground
water NTNCWS, compared to 25 States
for CWS, so there are, on average, fewer
States with NTNCWS data in each
region. Moreover there is no data about
NTNCWS from any States in the
Southeast region (Alabama, Florida,
Georgia, Mississippi, and Tennessee).
EPA therefore used the occurrence
distribution for ground water CWS as a
surrogate for ground water NTNCWS in
the Southeast. For surface water
NTNCWS, EPA used the occurrence
estimates from surface water CWS,
because the characteristics of source
water for NTNCWS are expected to be
similar to source water for CWS, and
there is a larger CWS data set to draw
from.
Table HI.C-5 of the January 2001 rule
(66 FR 6976 at 6998) shows EPA's
estimated arsenic occurrence
distributions for the U.S. The results are
comparable to those of two other arsenic
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occurrence studies: the National Arsenic
Occurrence Survey (Frey and Edwards,
1997) and USGS (2000).
In addition to the distributions of
system means, EPA estimated '
nationwide intra-system coefficients of
variation (ISCV). For a given water
system, the ISCV quantifies the
variation of mean arsenic levels at the
system's entry points to the distribution
system (i.e., sampling points of
individual wells and treatment points)
around the overall system mean. EPA
estimated separate ISCVs for ground
water CWS, surface water CWS, and
ground water NTNCWS. Each of these
ISCVs was assumed to be constant
throughout the U.S. EPA used the
estimated ISCVs as part of its cost
simulation model summarized today in
section II.E.
Since the completion of its occurrence
analysis for the arsenic rule (EPA
2000h), EPA has received additional
occurrence data from one State, North
Carolina. More occurrence data from
other States may become available in
the future.
2. Request for Occurrence Comments
Some stakeholders expressed concern
that EPA estimated nationwide
occurrence using data from only 25
States, and that the national occurrence
estimate was therefore not as reliable as
it should have been. Many commenters
provided occurrence data about their
individual system, which could not be
used in the statistical approach. Some
commenters suggested that EPA should
either request data from all States, or
else augment its data set with data from
other sources. As noted in EPA's
Response-to-Comments document for
the January 2001 rale, EPA's occurrence
estimates are based on finished water
data from States for which data of
adequate quality in the range of interest
(3-20 ug/L) were available. EPA
requests comment on the assumptions,
data, methodologies, and results of its
occurrence analysis, as well as any new
occurrence data that commenters
believe EPA should consider in its
occurrence assessment. EPA also
requests comment on •whether it is
appropriate to use long-term averages as
a proxy for compliance in computing
costs for various levels of the standard.
D. How did EPA Evaluate the Health
Bisks of Arsenic in Drinking Water?
\. Summary of Health Risk Elements
Arsenic ingestion at various levels has
been linked to a variety of health effects,
both cancerous and non-cancerous.
These health effects include cancer of
the bladder, lungs, skin, kidney, nasal
passages, liver, and prostate. Arsenic
ingestion has also been associated with
cardiovascular, pulmonary,
immunological, neurological, endocrine,
and reproductive and developmental
effects, hi almost all cases, the drinking
water levels at which these associations
have been found are higher than the
current 50 ug/L standard and the levels
typically found in U.S. drinking water.
Extrapolating these associations down
to levels of regulatory interest (i.e., less
than 50 ug/L) entails uncertainty and
there has been debate among
stakeholders over the appropriate
methodology for doing so. Of all the
studies noted in the report issued by the
National Research Council (NRC 1999)
and literature reviewed by EPA, the
Agency believes that those studies
focusing on bladder and lung cancer
provide the best basis to quantify dose
response relationships and extrapolate
these relationships down to the levels of
regulatory interest. Therefore, the
Agency based its assessment of the
quantifiable health risk reduction
benefits on the risks of arsenic-induced
bladder and lung cancers.
The Agency's approach for the health
risk quantitative analysis includes five
components. First, EPA developed
relative exposure factor (REF)
distributions, where the life-long REFs
indicate the sensitivity of exposure of an
individual relative to the sensitivity of
exposure of an "average" person
weighing 70 kilograms and consuming
approximately 2 liters of water per day.
These REFs incorporate data from the
recent EPA water consumption study
(EPA 2000a) with age, sex; and weight
data. Second, EPA calculated arsenic
occurrence distributions for the
population exposed to arsenic levels
above 3 ug/L. Third, EPA chose risk
distributions for bladder and lung
cancer for the analysis from Morales et
al. (2000), a peer-reviewed article
published in July 2000, which presented
additional analyses of bladder cancer
risks as well as estimates of lung and
liver cancer risks for the same
Taiwanese population analyzed in the
NRC report. EPA summarized and
analyzed the new information from the
Morales et al. (2000) article in a Notice
of Data Availability (NODA) (EPA
2000e) published on October 20, 2000
(65 FR 63027). Although the data used
were the same as used by the NRC to
analyze bladder cancer risk in their
1999 publication, Morales et al. (2000)
considered more dose-response models
and evaluated how well they fit the
Taiwanese data, for both bladder cancer
risk and lung cancer risk. Fourth, EPA
developed estimates of the projected
bladder and lung cancer risks faced by
exposed populations using Monte-Carlo
simulations, bringing together the
relative exposure factor, occurrence, and
risk distributions. These simulations
resulted in upper-bound estimates of the
actual risks faced by U.S. populations
exposed to arsenic concentrations at or
above 3 ug/L in their drinking water.
Finally, EPA identified three significant
sources of uncertainty and made
adjustments to address one of these to
derive alternate, lower risk estimates
that reflect exposure to arsenic in
cooking water and in food in Taiwan.
EPA also recognized and considered
qualitatively two other sources of
uncertainty (e.g., the shape of the dose
response curve at low exposure levels
and the different health and nutritional
status of the Taiwanese study
population relative to the typical U.S.
population) that it was not able to
quantify (see page 7021 of the January
22, 2001 rule) that might also lead to
lower risk estimates if it were possible
to account for them quantitatively. EPA
also indicated, in the preamble to the
January 2001 rule, that it believed that
its health risk analysis comprised a
plausible range of likely risk associated
with various concentrations of arsenic
in drinking water. This analysis is
described in more detail at pages 7001—
7009 and 7020-7021 of the January 22,
2001, rule. Finally, EPA considered the
non-monetizable benefits associated
with avoiding certain adverse health
impacts known to be caused by arsenic
at higher concentrations, which also
may be associated with low level
concentrations, which included other
nonquantified cancer endpoints and
adverse cardiovascular, pulmonary,
immunological, neurological, endocrine,
reproductive, and developmental
effects. EPA listed reductions in these
health effects as unquantified benefits in
Tables IH.E-3 and III.E-7 that listed the
monetizable benefits. In moving off the
feasible MCL of 3 ug/L, EPA considered
the costs and benefits, including the
unquantified benefits (66 FR 6976 at
7022 and 7023).
2. Request for Comment on Health
Issues
EPA has asked the National Academy
of Sciences (NAS) to update the findings
and recommendations of the NRC
report, Arsenic in Drinking Water (NRC
1999), based on new studies and
analyses, including EPA's risk analyses.
EPA recognizes that there are a number
of uncertainties inherent in its risk
analysis that reflect the state of existing
science, available research, and the
difficulties associated with applying
epidemiological data from one
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population to another. The NAS, in its
1909 NRC report, and the Science
Advisory Board, in its 2000 report (EPA
2000f), highlighted a number of key
issues, as have stakeholders who have .
participated in the arsenic rule
development process. EPA requests
comment and any additional data that
may be available in the following areas:
(1) Are the data from the
southwestern Taiwanese studies
presented in the NRC report still the
most appropriate data set for the dose-
response assessment and risk
estimation? What are the uncertainties
in the data on which the risk estimates
are based, and what is the likely effect
of these uncertainties on the
quantitative risk estimates?
(2) Did EPA's analyses of U.S. risk
provide appropriate adjustments for
population differences, including
factors such as diet, health status, life
style (e.g., smoking, cooking water use),
when extrapolating from the Taiwanese
study population to the U.S.
population? Is it possible and
appropriate for EPA to make additional
quantitative adjustments to account for
such differences using existing data?
(3) Part of EPA's analysis requires the
determination of an arsenic level that is
projected to cause an adverse effect in
one per cent of the population (EDoi). Is
the dose-response analysis conducted
by EPA, as well as any available more
recent data, adequate for estimating an
EDoi?
(4) Did EPA's analysis appropriately '
consider and characterize the available
data on mode of action of arsenic, the
dose-response information, and the
information on uncertainties, when
assessing the public health impacts?
(5) Are EPA's risk estimates at 3, 5,
10, and 20 ug/L consistent with
available scientific information,
including information from new
studies?
(6) What is known or can be inferred
about the latency period between
exposure to arsenic in drinking water
and increased incidence of cancer based
on existing research?
E. How Did EPA Calculate the National
Costs of Compliance With the Arsenic in
Drinking Water Rule?
1. Summary of Cost Elements of January
22, 2001 Rule and Record
EPA listed the national cost estimate
for the January 22,2001, rule in Table
1II.E.1 (66 FR 6976 at 7010). (This
information is discussed at greater
length in the Technology and Cost
document (EPA 2000i) in the record for
the January 22, 2001, rule.) The table
presented national cost estimates for the
MCL of 10 Hg/L and the other three
options considered in the proposed rule
published on June 22, 2000. Treatment
costs represent the vast majority of the
total national costs for all four MCL
options. For the MCL of 10 ug/L, the
treatment costs are estimated to be
$169.6 million per year using a 3%
discount rate and $193 million per year
using a 7% discount rate.
In summary, EPA developed the cost
of compliance estimate for the arsenic in
drinking water rule as follows. The
treatment costs were derived using
occurrence data, treatment train unit
costs, and decision trees. The
occurrence data provide the number of
systems that would need to install
treatment in each size category. The
treatment train unit cost estimates
provide a measure of how much a
technology will cost to install. Decision
trees vary by system size and are used
as a prediction of,the treatment
technology trains that facilities would
likely install to comply with the options
considered for the revised arsenic
standard. An analysis of the available
treatment trains for arsenic removal and
the unit costs for the 13 treatment trains
(listed in Exhibits A-7 through A-22ln
EPA 2000g) used in the national cost
estimate are described in the December
2000 document entitled "Technologies
and Cost for the Removal of Arsenic in
Drinking Water" (EPA 2000i). The
decision tree and a description of the
model used to calculate the national
cost estimate are described in the
December 2000 document entitled
Arsenic in Drinking Water Rule
Economic Analysis (EPA 2000g).
Many of the comments EPA received
on the June 2000 proposed rule were on
the national cost estimate and the
available treatment technologies. EPA
reviewed these comments and
comments from the Drinking Water
Committee of EPA's Science Advisory
Board. The January 2001 rule
incorporates a number of changes based
on these comments, which are
discussed in detail in sections V.F and
V.G of the preamble (66 FR 6976 at
7034) and are discussed more
extensively, in the Technology and Cost
document (EPA 2000i). The major
changes are summarized in today's
document.
EPA received many comments on the
proposed rule stating that the Agency
did not adequately consider problems
with waste generation and disposal
when evaluating which technologies
would be most appropriately used for
achieving compliance. Prior to issuing
the arsenic rule, EPA re-examined the
25 treatment trains considered for the
proposed rule. The Agency eliminated
five treatment trains due to concerns
about hazardous waste. The ability to
discharge brine streams to publicly
owned treatment works (POTWs) was
another issue related to waste
generation and disposal. Comments
indicated that potential increases in
total dissolved solids and technically
based local limits at the POTW would
limit the discharge of brines to POTWs.
EPA eliminated brine discharge to
POTWs from .activated alumina
processes as a Best Available
Technology due to the arsenic
concentration in the brine. EPA also
significantly reduced the use of anion
exchange with POTW discharge in the
decision tree for the January 2001 rule.
These issues are discussed in greater
detail on pages 7036-7038 of the
. January 2001 preamble.
The national cost estimate generated a
large number of stakeholder comments.
Many of these comments stated that
EPA underestimated the costs for
implementing the proposed rule. Many
of these comments referred to the report
"Cost Implications of a Lower Arsenic
MCL" as the basis for their comments.
This report (Frey et al. 20003) was
published by the American Water
Works Association Research Foundation
(AWWARF) in May 2000. The national
cost estimates in the AWWARF report •
•were updated in October 2000 (Frey et
al. 2000b), For the MCL of 10 ug/L, the
October 2000 Update lists a national
compliance cost estimate of $345
million per year with no sensitivity
considerations (lower bound) and $585
million per year with sensitivity
considerations (upper bound). (These
upper and lower bound estimates result
from different assumptions about cost
model input variables.) EPA reviewed
the May 2000 AWWARF report and the
October 2000 update and summarized
factors in the report in detail on pages
7040-7041 of the January 2001
preamble that EPA identified as being
key reasons for the differences in cost
estimates. These factors include
differences in flow rate assumptions,
unit costs, and national estimates for
arsenic occurrence. The Arsenic
Response-to-Comments Document (EPA
2000J) also includes more detail on
EPA's review of the national cost
estimates in "Cost Implications of a
Lower Arsenic MCL."
In commenting on the proposed rule,
the SAB also expressed concern that the
Agency's cost estimates appeared low.
The SAB identified two concerns in
particular: (1) The assumptions
regarding disposal options for brine and
other residuals (see discussion in
section II. E. 1. of the revision EPA
made to address these concerns); and (2)
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37625
whether the technologies identified as
BAT have been implemented or
optimized for arsenic removal at the
treatment plant scale, and whether
doing so would reduce their
effectiveness for the other purpose for
which they have been designed, in
which case compliance costs could be
underestimated.
A Working Group of the National
Drinking Water Advisory Council
(NDWAG) is reviewing the costing
methodologies, assumptions, and
information underlying the system-size
.as well as the aggregated national
estimate of system costs of the arsenic
rule. As a part of this review, the
Working Group is also evaluating
significant alternative costing
approaches where there is adequate
information upon which to evaluate the
basis for the alternate estimates or
approaches, including the AWWARF
cost reports. The group may identify
and comment on additional factors
affecting these cost estimates (e.g.,
number of entry points to the
distribution system) in addition to those
discussed in the January 2001 rule. The
NDWAC Working Group will make a
recommendation to the full NDWAG
based on their review of the national
cost estimates.
2. List of Cost Issues and Request for
Comments .
Specific questions related to the cost
of compliance analysis for the arsenic
rule on which EPA is interested in
receiving public comment include the
following:
(1) Did EPA use appropriate
"baseline" assumptions (e.g.,
occurrence, co-occurring contaminants,
affected systems, entry points, design
and average flows, availability of land,
in-place treatment)? If not, how could
these assumptions be improved and
what data would support such revised
assumptions?
(2) Did EPA identify an appropriate
set of treatment "trains" and make
appropriate assumptions about the costs
of technologies included in those
treatment trains as a part of the process
of developing national cost estimates?
Has EPA identified restrictions that may
limit or eliminate treatment technology
and residuals management
combinations, including the application
of treatment technologies to arsenic on
a large scale, and integration of arsenic
removal with other treatment plant
objectives? If not, how could these
assumptions and inputs be improved?
(3) Did EPA use an appropriate
"decision tree" for the final rule? If not,
how can that decision tree be improved?
F. How Did EPA Calculate the Benefits
of the Arsenic Rule?
1. Summary of the January 22, 2001,
Benefits Assessment
Of the various health effects linked to
arsenic ingestion, in the January 2001
rule EPA prepared a quantitative
assessment of lung and bladder cancer.
Other health effects and possible non-
health benefits that EPA was unable to
quantify were considered qualitatively
as required by SDWA, and as discussed
in the January 2001 rule.
The process by which EPA analyzed
the benefits of reduced bladder and lung
cancer cases for the arsenic rule
involved several steps. These steps
included the calculation of risk
reductions, calculation of the number of
cancer cases avoided, monetization of
avoided bladder and lung cancer cases,
qualitative analysis of non-quantifiable
benefits, and a sensitivity analysis of
benefits estimates to examine the
impacts of discounting over a latency
period and accounting for other
adjustments such as voluntariness and
controllability.
Using the risk estimate calculations
described in section E.G. of today's
notice, EPA calculated the number of
bladder and lung cancer cases avoided
for CWSs and NTNCWSs (see Table
III.D-3, 66 FR 6976 at 7009). Note that
EPA derived separate cancer risks for
NTNCWSs, as summarized in the
preamble to the June 2000 proposal
(pages 38952-38956) and described in
section 5.3.3 of the Economic Analysis
(EPA 2000g). The lower- and upper-
bound risk estimates were applied to the
exposed population to generate cases
avoided for Community Water Systems
(CWS) serving fewer than 1 million
customers. Since the Agency had
arsenic occurrence information for very
large systems (those serving greater than
one million customers), their system-
specific arsenic distributions could be
directly computed and cases avoided
calculated from these distributions
(appendix b.2 in EPA 2000g). In the
proposal and January 2001 rule, EPA
adjusted the number of bladder cancer
cases avoided to reflect a possible lower
mortality rate in Taiwan (a lower death
rate would increase the number of
estimated Taiwanese cases to include
more non-fatal cancers) than was
assumed in the risk assessment process,
which is described in section 5.4.1 of
the Arsenic Economic Analysis (EPA
2000g). The Agency adjusted the upper-
bound U.S. cancer cases avoided to
assume an 80% mortality rate for
bladder cancer and 100% fatality for
lung cancer in Taiwan. The Agency then
divided the U.S. cases avoided into
morbidity (non-fatal) and premature
fatality cases based on U.S. mortality
rates of 26% for bladder cancer and
88% for lung cancer.
In order to monetize the benefits from
bladder and lung cancer cases avoided,
the Agency used two different values.
First, a Value of Statistical Life (VSL)
estimate was applied to those cancer
cases that result in a mortality. As
noted, EPA assumed a 26% mortality
rate for bladder cancer and an 88%
mortality rate for lung cancer. The
current VSL value used by the Agency
is $6.1 million, in 1999 dollars (66 FR
6976 at 7012). VSL does not refer to the
value of an identifiable life, but rather
to the value of small reductions in
mortality risks in a population. A
"statistical" life is thus the sum of small
individual risk reductions across an
entire exposed population and is not the
value for saving a particular individual's
life.
Second, EPA used a Willingness to
Pay (WTP) value (66 FR 6976 at 7012)
to monetize the cancer cases that do not
result in a mortality. A WTP value for
avoiding a non-fatal cancer is currently
not available; therefore the Agency used
a WTP estimate to reduce a case of
chronic bronchitis as a proxy. The mean
value of this WTP estimate is $607,000
in 1999 dollars. A complete discussion
of the VSL and WTP values and how
they are calculated can be found in
Chapter 5 of the Arsenic Economic
Analysis (EPA 2000g).
There are also a number of non-
quantifiable benefits that EPA
considered in its analysis of the benefits
for the arsenic rule. Chief among these
are certain health impacts identified in
various studies involving arsenic levels
greater than 50 ng/L. To date, the extent
to which these impacts occur at levels
below 50 fig/L has not been determined.
These additional health effects include
other cancers such as skin, kidney, nasal
passage, liver, and prostate cancers and
non-cancer endpoints such as
cardiovascular, pulmonary,
immunological, neurological, and
endocrine impacts. These health effects
and the relevant studies linking these
health effects to arsenic in drinking
water are discussed in section III.D of
the preamble to the rule (66 FR 6976 at
7000). Table III.E-3 in the preamble to
the rule.(66 FR 6976 at 7012) shows the
estimated benefits from reducing arsenic
in drinking water for arsenic levels of 3,
5,10, and 20 Hg/L. This table also
includes a listing of the potential non-
quantifiable benefits associated with
reducing arsenic in drinking water.
The Agency also provided a
sensitivity analysis on benefits estimates
in the rule to examine the impacts of
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discounting over a latency period and
adjustments for income growth and the
nature of the risk (the extent to which
the risk is voluntary and controllable).
In a July 2000 letter, the EEAC of the
SAB recommended that benefits
estimates for environmental regulations
include adjustments for latency and for
income growth in the primary analysis,
while adjustments for other factors,
such as die extent to which risk is
voluntary or controllable, be addressed
in a sensitivity analysis. For the arsenic
rule, the Agency chose to address all of
these factors in a sensitivity analysis
because it lacked quantitative data on
cancer latency periods associated with
arsenic exposure in drinking water. The
sensitivity analysis used a range of
latencies from 5 to 20 years and
discount rates of 3 and 7%. It also
adjusted for income growth and
included a 7% increase in valuation to
account for the lack of voluntariness
and controllability of risk. The
sensitivity analysis showed that the
adjustments to monetized benefits could
range from a 10% increase (accounting
for income growth only) to a 70%
decrease (accounting for income growth,
latency, and voluntariness/
controllability). The sensitivity analysis
did not provide estimates accounting
only for latency and income growth.
Tables III.E-5 and III.E-6 in the January
2001 preamble illustrate the sensitivity
of monetized benefits estimates to
different assumptions for latency period
duration, discount rate, rate of income
growth, and inclusion of a voluntariness
and controllability factor. A more
detailed description of this analysis is
shown in section III.E.2.b of the
preamble to the rule (66 FR 6976 at
7012) and Chapter 5 of the Arsenic
Economic Analysis (EPA 2000g).
2. List of Key Benefit Analysis Issues
Significant issues associated with the
benefits analysis for the arsenic in
drinking water rule addressed topics
such as the timing of health benefits
accrual (latency) and the Agency's
consideration of non-quantifiable
benefits in its regulatory decision-
making process. The Agency requests
comments on these and related issues in
the following summary.
Specific issues related to the benefits
analysis for the arsenic rule include:
a. Discounting benefits over a cancer
latency period. The SAB has
recommended that EPA should discount
its monetized benefits over a cancer
latency period (EPA 2000d). A latency
period is generally defined as the time
between exposure to an environmental
carcinogen and the resulting cancer
fatality. Precise information on the
latency period for most cancers is
generally unavailable, but latency
periods can be significant. The latency
period may also be defined in several
different ways. This period can be
defined as the time between exposure
and the resulting fatality or the time
between exposure and onset or
diagnosis of the cancer. This definition
does not consider the time between
exposure and early adverse changes at
the cellular level in the body (i.e., before
clinical expression of cancer). Definition
of the latency period can have a
significant impact on the length of time
over which benefits are discounted,
especially for cancer illnesses •where the •
period of morbidity (e.g., non-fatal
illness) is lengthy. EPA has specifically
requested the National Academy of
Sciences, in their review of the health
risks of arsenic in drinking water, to
examine this issue in more detail and
discuss what is known or can be
inferred about the latency period
between exposure to arsenic in drinking
water and increased incidence of cancer
based on existing research.
b. Consideration of non-quantifiable
benefits in the regulatory decision-
making process. Some stakeholders
have argued that EPA did not fully
consider the non-quantifiable benefits in
its decision-making process for the
arsenic rule and that EPA should have
performed sensitivity analyses to
characterize the potential magnitude of
these benefits. Other stakeholders have
argued that EPA placed too much
emphasis on non-quantifiable benefits
in the choice of the arsenic MCL. EPA
requests comment on how to handle
non-quantifiable benefits in its selection
of a final arsenic MCL.
3. Request for Comments on Benefits
(1) How should total benefits and
costs and incremental benefits and costs
be addressed in the rule in analyzing
regulatory alternatives to ensure
appropriate consideration by decision
makers and the public?
(2) How should latency be addressed
in the benefits estimates for the final
rule when existing literature does not
provide specific quantitative estimates
of latency periods associated with
exposure to arsenic in drinking water?
(3) Should reduction/elimination of
exposure be evaluated as a separate
benefits category, in addition to or in
conjunction with mortality and
morbidity reduction?
(4) How should health endpoints
(other than bladder and lung cancer) be
addressed in EPA's analysis, when ,
existing literature does not provide
specific quantification, to ensure
appropriate consideration by decision
makers and the public?
(5) How should uncertainties be
addressed in EPA's analysis to ensure
appropriate consideration by decision
makers and the public?
G. What Process Is EPA Planning for
Review of Financial, Technical, and
Planning Tools for Small Systems?
1. Small System Review Process
As part of its overall review of the
arsenic rule, EPA wishes to reassess the
financial, technical, and planning tools
available to help small systems achieve
compliance. SDWA provides special
consideration for small systems in a
number of areas and also created the
Drinking Water State Revolving Fund
(DWSRF) to help systems, including
small systems, comply with the
provisions of the Act. The DWSRF
provides lowi interest loans, and allows
forgiveness of principal for communities
identified by the States as
disadvantaged. The Agency believes
that State capacity development
strategies offer a useful framework
within which to address small system
issues. The Agency seeks comment to
help it reassess the financial, technical,
and planning tools available to small
systems and determine what, if any,
additional steps the Agency should take
to facilitate compliance with a revised
arsenic standard.
2. List of Small System Issues
a. Affordability, availability of
financial assistance, and treatment
technology. Extensive concerns have
been raised regarding the ability of
households served by small systems to
afford compliance with a revised arsenic
standard. In the January 2001 rule, the
Agency attempted to address many of
these concerns. The preamble of the
January 2001 rule emphasized the
framework established by SDWA to
consider affordability and the tools
available to help address affordability
concerns. These tools include financial
assistance; and extended compliance
time frames through exemptions. SDWA
also provides for small system
variances, but EPA determined in the
January 2001 -rule that affordable small
system compliance technologies are
available for all categories of system
size, so this option is not available for
the new arsenic standard published in
the January 2001 rule.
The January 2001 preamble points out
that about $1 billion/year is being made
available to large and small systems
through the Drinking Water State
Revolving Fund (DWSRF), and about
$780 million/year is being made
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37627
available through the water and waste
disposal program of the Rural Utilities
Service (RUS) of the Department of
Agriculture. EPA also noted that almost
one quarter of the DWSRF loans have
been made to systems States classified
as disadvantaged (66 FR 6796 at 7020).
Treatment technology is another issue
around which small system concerns
have clustered. The major concern
voiced in this regard has been that small
systems may not be able to apply the
lower cost compliance technologies
identified by EPA. The most significant
issue relates to the application of Point-
of-Use (POU) technology. Under the
arsenic rule, EPA has designated POU
technology as an affordable compliance
technology. The Agency recognizes that
application of POU technology for
compliance is not presently a common
practice and water systems would face
a number of challenges in implementing
such an approach. EPA's probability
decision trees (Exhibits A-7 through A-
22 in the Economic Analysis (EPA
2000g)) assigned POU technologies to
approximately 5% of systems serving
fewer than 500 in the decision tree. The
Agency believes that customers may be
quite supportive of a POU solution once
they understand the cost-savings it
offers based upon pilot studies and
information that EPA has analyzed.
b.-SDWA Capacity Development
Framework. SDWA recognized that
small systems would find it more
challenging than large systems to
achieve the public health protection
goals of the Act. In amending SDWA in
1996, Congress found that effective
protection of public health requires
water systems with adequate
managerial, technical, and financial
capacity. Congress further found that
compliance with the requirements of
SDWA continues to be a concern at
public water systems experiencing
technical and financial limitations; and
Federal, State, and local governments
need more resources and more effective
authority to attain the objectives of
SDWA. In response to these findings,
Congress included, in the amendments a
number of provisions designed to help
EPA and the States address the needs of
small systems, including, for the first
time, the State Revolving Loan Fund for
assisting drinking water systems in
complying with standards.
These provisions included new
flexibility for EPA in setting standards
and compliance time frames; explicit
authority to allow Point-of-Use
technologies for compliance; broader
and more flexible authority for issuing
exemptions to provide systems with
additional time to comply; small system
variances in cases where EPA
determines that affordable small system
compliance technologies are not
available; and financial assistance
through a new drinking water State
revolving fund. In order to help focus
these and other tools on helping systems
develop managerial, technical, and
financial capacity, Congress created a
strong incentive for States to develop a
"capacity development strategy." States
were given broad flexibility in designing
their strategy, but were required to
consider a number of issues including
how they would use the authority and
resources of SDWA or other means to
assist systems in complying with
regulations and to encourage the
development of partnerships between
systems to enhance their capacity.
All States have developed strategies
consistent with the SDWA framework.
EPA believes that implementation of a
revised arsenic standard will be the first
major test of these strategies. SDWA
clearly anticipated that systems would
need to enhance their technical,
financial, and managerial capacity in
order to achieve the public health
protection objectives of the law. The
extensive concerns which have been
voiced about systems ability to meet a
revised arsenic standard serve to
confirm the need for such
enhancements.
Successful implementation of a
revised standard will require that States
focus on developing system capacity by
fully utilizing the flexibilities available
under SDWA. In particular, the Agency
believes that appropriate use of these
three provisions will be essential:
(1) DWSRF assistance, including
principal forgiveness for disadvantaged
communities and set-aside funds to
assist systems through a State's capacity
development strategy.
(2) Exemptions to allow additional
time for systems that demonstrate the
need for such time to achieve
compliance. Such systems of any size
can be granted an additional 3 years
beyond the compliance date for the
revised MCL to achieve compliance,
while systems serving <3300 persons
can be granted up to 6 additional years
beyond that date. This extra time can be
used to obtain financial assistance or
undertake restructuring or other changes
to achieve compliance.
(3) Application of Point-of-Use (POU)
technology.
States may wish to utilize their
capacity development strategy as a
framework within which to plan the
most effective utilization of all of the
tools available. In addition to the SDWA
provisions discussed previously,
another important tool is financial
assistance available through the United
States Department of Agriculture's Rural
Utilities Service.
3. Request for Small Systems Comment
EPA invites comments on all aspects
of small system compliance with a
revised arsenic standard. In particular,
the Agency seeks comment on the
following issues:
(1) What additional guidance,
information, or other assistance, if any,
do States need to help them develop
and apply system-level affordability
criteria (for prioritizing use of drinking ,
water revolving funds in a State; and for
determining whether or not to grant
exemptions)?
(2) Will exemptions allowing needy
systems additional time to achieve
compliance be a useful tool? What
guidance, information, or other
assistance, if any, should EPA make
available to States and or systems
relative to exemptions?
(3) To what extent can systems lower
their compliance costs or enhance their
ability to comply by forming
partnerships with other systems or
otherwise restructuring their
operations? What barriers (physical and/
or institutional) exist to the formation of
these partnerships? What guidance, .
information, or other assistance, if any,
should EPA make available to States
and or systems to assist in the formation
of system-level partnerships?
(4) What challenges or barriers exist to
adoption of POU technology? What do
EPA and or the States need to do to
facilitate application of POU
technology?
(5) What additional guidance,
information, or other assistance do
States need to help them refine their
capacity development strategies to
facilitate compliance with a revised
arsenic standard?
HI. Process To Be Employed After
Technical Reviews and Public
Comment
A. How Will EPA Notify the Public of
Results of the Technical Reviews and
the Nature of the Public Comments?
As previously noted, the findings of
the expert review panels will be made
publicly available, hi addition, EPA will
publish a notice with a summary of
these findings for public comment. The
purpose of the notice will be to provide
EPA's perspective on the findings of the
review of the costs, benefits, and science
underlying the arsenic rule. In addition,
the notice will summarize comments
received on this proposal and EPA's
perspective on those comments. Finally,
the notice will provide an indication of
how the Agency plans to synthesize this
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new information with, respect to final
decisions on the arsenic in drinking
water rule. EPA expects that the notice
will be published in the Fall of 2001.
B. What Process Will EPA Use To Make
Final Decisions on the Rule?
The process of making final decisions
on the arsenic in drinking water
regulation will involve legal, regulatory,
policy, and scientific considerations.
The results of the expert panels' reviews
and public comment will be significant
and important sources of information
that will be fully considered by the
Agency as it makes a final decision. In
making a final decision, EPA will also
exercise judgment and discretion based
on the record and all applicable legal,
regulatory, and policy requirements.
EPA expects to make a final decision on
how to proceed with the arsenic rule by
February 22, 2001, after considering the
reviews and public comments.
IV. Administrative Requirements
A. Executive Order 12866, Regulatory
Planning and Review
Under Executive Order 12866, [58
Federal Register 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;
13) 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 the January 22, 2001, rule is a
"significant regulatory action" because
it will have annual costs of more than
$100 million. Because this proposal is
an extension of a rulemaking published
on January 22,2001 (66 FR 6976), and
is based on the record for that
rulemaking, EPA has complied with this
Executive Order through the economic
analyses prepared for the January 22,
2001, rulemaking. Those analyses were
reviewed by OMB. In addition, this
action was submitted to OMB for
review. Changes made in response to
OMB suggestions or recommendations
are documented in the public record for
W-99-16-VI.
B. Regulatory Flexibility Act (RFA), as
Amended 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 requirements
under the Administrative Procedure Act
or any other statute unless the agency
certifies that the rule will not have a
significant economic impact on a
substantial number of small entities.
Small entities include small businesses,
small organizations, and small
governmental jurisdictions.
The RFA provides default definitions
for each type of small entity. It also
authorizes an agency to use alternative
definitions for each category of small
entity, "which are appropriate to the
activities of the agency" after proposing
the alternative definition(s) in the
Federal Register and taking comment (5
U.S.C. 601(3)-(5)). In addition to the
above, to establish an alternative small .
business definition, agencies must
consult with the Small Business
Administration's (SBA) 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 at 7620; 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.
As noted in the previous section, this
proposal is an extension of, and relies
on the record of, a previous rulemaking
concerning the same regulatory options.
In accordance with section 603 of the
RFA, EPA prepared an initial regulatory
flexibility analysis (IRFA) for the
original proposed rule, published in the
Federal Register on June 22, 2000 (EPA
2000b), and convened a Small Business
Advocacy Review Panel to obtain advice
and recommendations of representatives
of the regulated small entities in
accordance with section 609(b) of the
RFA. A detailed discussion of the
Panel's advice and recommendations is
found in the Panel Report (EPA 1999).
The June 2000 proposed rule presented
a summary of the Panel's
recommendations (65 FR 38888 at
38963).
As required by section 604 of the
RFA, EPA also prepared a final
regulatory flexibility analysis (FRFA) for
the January 2001 rule (EPA 2001a). The
FRFA and the January 2001 arsenic
rale's preamble (66 FR 6976 at 7047)
addressed the issues raised by public
comments on the ERFA, which was part
of the regulatory impact analysis for the
proposed rule (65 FR 38888 at 38962;
EPA 2000b). The FRFA (EPA 2000J) is
available for review in the docket. The
previous analyses encompass all of the
options proposed again today, and as a
result, EPA is relying on those analyses
for compliance with the RFA for this
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
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37629
UMRA a small government agency plan.
. The plan must provide for notifying
potentially affected small governments,
enabling officials of affected small
governments to have meaningful and
timely input in the development of EPA
regulatory proposals with significant
Federal intergovernmental mandates,
and informing, educating, and advising
small governments on compliance with
the regulatory requirements.
EPA has determined that the January
22, 2001, rule contains a Federal
mandate that may result in expenditures
of $100 million or more for State, Tribal,
and local governments, in the aggregate,
or the private sector in any one year.
Because today's proposal is an
extension of the January 2001 arsenic
rulemaking and discusses only those
options which were fully analyzed in
the previous rulemaking, EPA is relying
on the record of the January, 2001 rule
to provide the analyses required by
UMRA. A detailed description of this
analysis is presented in EPA's Economic
Analysis of the arsenic rule (EPA 2000g)
which is included in the Office of Water
docket for the arsenic rule, and
summarized in the January 2001
preamble (66 FR 6976 at 7049). Through
targeting mailing of this notice to
entities on the arsenic mailing list, we
will continue to solicit State, local, and
Tribal access and dialog on the arsenic
rule. EPA will also develop a small
government agency plan.
D. Paperwork Reduction Act (PRA)
• The information collection
requirements in this proposed rule were -
previously submitted for approval to the
Office of Management and Budget
(OMB) under the provisions of the
Paperwork Reduction Act, 44 U.S.C.
3501 et seq. As noted in previous
sections, today's proposal is an
extension of a previous rulemaking
which analyzed the same options
presented today. As a result, EPA is
. relying on the PRA analyses prepared
for the January 2001 rulemaking and its
proposal for compliance with the PRA
for this rule. OMB has already reviewed
and approved the information collection
request (ICR) in the previous rulemaking
and assigned OMB control number
2040-0231. This action does not impose
any additional information collection
burden under the provisions of the
Paperwork Reduction Act, 44 U.S.C.
3501 et seq.
E. 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.
EPA's analysis of the NTTAA's
application to this rulemaking is
described in the June 22, 2000, proposal
at 65 FR 38971-38972 and the January
22, 2001, preamble at 66 FR 7051. EPA
requests comment on this analysis.
F. 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. The Agency has
considered environmental justice
related issues concerning the potential
impacts of this action and consulted
with minority and low-income
stakeholders.
In the preamble to the June 2000
proposal (65 FR 38888 at 38972), EPA
noted arsenic concerns raised during the
March 12,1998, environmental justice
stakeholder meeting. The issues raised
included confusion over units of
measure of test results (i.e., ppb and ug/
L), effects on sensitive subpopulations
(e.g., incidence of diabetes in Tribal
communities), infeasibility of regional
consolidation, affordable treatments for
small systems, increased access to
funding, considering regional needs in
standard setting, more training, and
protection of low income communities.
The Agency took these issues into
consideration during the development
of the January 2001 arsenic rule and the
response-to-comments document. The
public is invited to comment on EPA's
analysis of environmental justice as it
relates to today's proposal (which was
discussed in the June 2000 proposal and
January 2001 rule) and to recommend
additional methods to address
environmental justice concerns with the
approach for treating arsenic in drinking
water.
G. 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
proposed rule is not subject to Executive
Order 13045 because 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. The public is invited to '
submit or identify any new peer-
reviewed studies and data that assess
results of early life exposure to arsenic
via ingestion.
H. 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."
Under section 6 of Executive Order
13132, EPA may not issue a regulation
that has federalism implications,
imposes substantial direct compliance
costs, and is not required by statute
(unless the Federal government
provides the funds necessary to pay the
direct compliance costs incurred by
State and local governments, or EPA
consults with State and local officials
early in the process of developing the
proposed regulation). EPA also may not
issue a regulation that has federalism
implications and that preempts State
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law, unless the Agency consults with
State and local officials early in the
process of developing the proposed
regulation. If EPA complies by
consulting, Executive Order 13132
requires EPA to provide to OMB in a
separately identified section of the
preamble to the rule, a federalism
summary impact statement (FSIS). The
FSIS must include a description of the
extent of EPA's prior consultation with
State and local officials, a summary of
the nature of their concerns and the
agency's position supporting the need to
issue the regulation, and a statement of
the extent to which the concerns of
State and local officials have been met.
Also, when EPA transmits a draft final
rule with federalism implications to
OMB for review pursuant to Executive
Order 12866, EPA must include a
certification from the agency's
Federalism Official stating that EPA has
met die requirements of Executive Order
13132 in a meaningful and timely
manner.
EPA has concluded that this proposed
rule will have federalism implications;
these are the same federalism
implications discussed and analyzed in
the June 2000 and January 2001 arsenic
rules. EPA provided the Office of
Management and Budget (OMB) with a
federalism summary impact statement
(FSIS) in the preamble to the proposed
and final rules. EPA provided the FSIS
on page 7052 of the January 2001 rule
(66 FR 6976).
I. 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 the Indian tribes."
This proposed rule may have tribal
implications. It may have substantial
direct compliance costs 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 the Indian
tribes, as specified in Executive Order
13175. As a result of administrative
review of the regulation published on
January 22, 2001, the Environmental
Protection Agency (EPA) is requesting
additional comments on the regulatory
options via this proposal. In developing
the January 2001 rule, EPA consulted
with Tribal governments to permit them
to have meaningful and timely input
into its development, as described in the
preamble (66 FR 6976 at 7052). In the
spirit of Executive Order 13175, and
consistent with EPA policy to promote
communications between EPA and
tribal governments, EPA specifically
solicits additional comment on this
proposed rule from tribal officials.
/. Consultations With the Science
Advisory Board, National Drinking
Water Advisory Council, and the
Secretary of Health and Human Services
In accordance with sections 1412 (d)
and (e) of SDWA, the Agency discussed
or submitted possible arsenic rule
requirements to the Science Advisory
Board, National Drinking Water
Advisory Council (NDWAC), and to the
Secretary of Health and Human Services
and requested comment from the
Science Advisory Board on the arsenic
rule, as described in the January 2001
preamble (66 FR 6976 at 7053). In
addition, the April 23, 2001 proposed
rule (66 FR 20580) outlines the
additional consultations planned with
NDWAC. EPA will continue contacts
with the Department of Health and
Human Services during the arsenic rule
review process.
K. Likely Effect of Compliance With the
Arsenic Rule on the Technical,
Financial, and Managerial Capacity of
Public Water Systems
Section 1420(d)(3) of SDWA as
amended requires that, in promulgating
a National Primary Drinking Water
Regulation (NPDWR), the Administrator
shall include an analysis of the likely
effect of compliance with the regulation
on the technical, financial, and
managerial capacity of public water
systems. EPA provided the analysis
performed to fulfill this statutory
obligation for the January 2001 rule
(EPA 2000a). During this
reconsideration process, EPA will
review the capacity issues further.
L. Executive Order 13211, Actions
Concerning Regulations That
Significantly Affect Energy Supply,
Distribution, or Use
Executive Order 13211, "Actions
Concerning Regulations That
Significantly Affect Energy Supply,
Distribution, or Use" (66 FR 28355; May
22, 2001), provides that agencies shall
prepare and submit to the Administrator
of the Office of Information and
Regulatory Affairs, Office of
Management and Budget, a Statement of
Energy Effects for certain-actions
identified as "significant energy
actions." Section 4(b) of Executive
Order 13211 defines "significant energy
actions" as "any action by an agency
(normally published in the Federal
Register) that promulgates or is
expected to lead to the promulgation of
a final rule or regulation, including
notices of inquiry, advance notices of
proposed rulemaking, and notices of
proposed rulemaking: (l)(i) that is a
significant regulatory action under
Executive Order 12866 or any successor
order, and (ii) is likely to have a
significant adverse effect on the supply,
distribution, or use of energy; or (2) that
is designated by the Administrator of .
the Office of Information and Regulatory
Affairs as a significant energy action."
We have not prepared a Statement of
Energy Effects for this proposed rule
because this rule is not a significant
energy action, as defined in Executive
Order 13211. While this rule is a
significant regulatory action under
Executive Order 12866, it is not likely
to have a significant adverse effect on
the supply, distribution, or use of
energy.
V. References
Chiou, H.-Y., S.-T. Chiou, Y.-H. Hsu, Y.-L.
Chou, C.-H. Tseng, M.-L. Wei, and C.-J.
Chen. 2001. Incidence of transition cell
carcinoma and arsenic in drinking water: A
follow-up study of 8,102 residents, in an
arsenic-endemic area in Northeastern
Taiwan. American Journal of
Epidemiology. 153:411-^418.
Frey, M. M. and M. A. Edwards. 1997.
Surveying Arsenic Occurrence. Journal of
the American Water Works Association.
89(3):105-117.
Frey, M., J. Chwirka, S. Kommineni, and Z.
Chowdhury. 2000a. "Cost Implications of a
Lower Arsenic MCL". May 5, 2000.
American Water Works Association
Research Foundation, Denver, CO.
Frey, M., J. Chwirka, S. Kommineni, and Z.
Chowdhury. 2000b. "Update Cost
Implications of a Lower Arsenic MCL".
October 10, 2000.
Morales, K.H., L. Ryan, T.-L. Kuo, M.-M. Wu
and C.-J. Chen. 2000. Risk of internal
cancers from arsenic in drinking water.
Environmental Health Perspectives
108:655-661.
National Research Council. 1999. Arsenic in
Drinking Water. Washington, DC. National
Academy Press.
US EPA. 1996. Proposed Guidelines for
Carcinogenic Risk Assessment; Notice.
Federal Register. Vol 61, No. 79, p. 17960.
April 23,1996.
US EPA. 1998a. National Primary Drinking
Water Regulations: Consumer Confidence
Reports. Final Rule. Federal Register. Vol.
63, No. 160, p. 44512. August 19, 1998.
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37631
US EPA. 1998b. Benefits Working Group
Report to the National Drinking Water
Advisory Council, unpublished. October
29,1998.
US EPA. 1999. Analytical Methods Support
Document for Arsenic in Drinking Water.
Prepared by Science Applications
International Corporation under contract
with EPA. December 1999. EPA-815-R-00-
010. Available on web at wwiv.epa.gov/
safewater/arsenic.html.
US EPA. 2000a. Estimated Per Capita Water
Ingestion in the United States: Based on
Data Collected by the United States
Department of Agriculture's (USDA) 1994-
1996 Continuing Survey of Food Intakes by
Individuals. Office of Water, Office of
Standards and Technology. EPA-822-00-
008. April 2000.
US EPA. 2000b. National Primary Drinking
Water Regulations; Public Notification
Rule; Final Rule. Federal Register. Vol. 65,
No. 87, p. 25982. EPA 815-Z-00-001. May
4, 2000. Available on web at wivw.epa.gov/
safe water/pn .h tml.
US EPA. 2000c. 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. EPA 815-Z-00-004 June
22, 2000. Available on web at
www.epa.gov/safewater/arsenic.html.
US EPA. 2000d. SAB Report from the
Environmental Economics Advisory
Committee (EEAC) on EPA's White Paper
"Valuing the Benefits of Fatal Cancer Risk
Reduction. EPA-SAB-EEAC-00-013. July
27, 2000.
US EPA. 2000e. National Primary Drinking
Water Regulations; Arsenic and
Clarifications to Compliance and New
Source Contaminants Monitoring; Notice of
Data Availability. Federal Register.
Volume 65, Number 204. October 20, 2000.
Page 63027-63035. Available on web at
www.epa.gov/safewater/arsenic.htmL
US EPA. 2000f. Arsenic Proposed Drinking
Water Regulation: A Science Advisory
Board Review of Certain Elements of the
Proposal. EPA-SAB-DWC-1-001.
December 12, 2000. Available on web at
www.epa.gov/sab.
US EPA. 2000g. Arsenic Economic Analysis.
Prepared by Abt Associate for Office of
Ground Water and Drinking Water. EPA
815-R-00-026 December 2000. Available
on web at www.epa.gov/safewater/
arsenic.html.
US EPA. 2000h. Arsenic Occurrence in
Public Drinking Water Supplies. Prepared
by ISSI for EPA Office of Ground Water
and Drinking Water. EPA 815-R-00-023.
December 2000. Available online at
www.epa.gov/safewater/arsenic.html.
US EPA. 2000i. Arsenic Technologies and
Costs for the Removal of Arsenic from
Drinking Water. EPA 815-R-00-028.
December 2000. Available on web at
www.epa.gov/safewater/arsenic.himl.
US EPA. 2000J. Arsenic Response-to-
Comments Document for W-99-16-III.
December 2000.
US EPA. 2000k. Final Regulatory Flexibility.
Analysis (FRFA) for the Final Arsenic
Rule. December 29, 2000.
US EPA. 2000L SAB Report on EPA's White
Paper, Valuing the Benefits of Fatal Cancer
Risk Reduction. EPA-SAB-EEAC-00-013.
July 27, 2000. Available on web at
www.epa.gov/sdb/eeacf013.pdf.
US 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. EPA 815-Z-01-001. January 22, 2001.
Available on web at wivw.epa.gov/
safewater/arsenic.html.
US 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. Available on web at
www.epa.gov/safewater/arsenic.html.
US 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.
Available on web at www.epa.gov/
safewater/arsenic.html.
US EPA. 2001d. National Primary Drinking
Water Regulations; Arsenic and *
Clarifications to Compliance and New
Source Contaminants Monitoring; Notice;
request for nominations to the Arsenic Cost
Working Group of the National Drinking
Water Advisory Council. Vol. 66, No. 87,
p. 22661. May 4, 2001. Available on web
at www.epa.gov/safewater/arsenic.html.
US EPA. 2001e. 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. 99, p. 28342. May 22,
2001. Available on web at www.epa.gov/
safewater/arsenicJhtml.
US EPA. 2001f. National Primary Drinking
Water Regulations; Arsenic and
Clarifications to Compliance and New
Source Contaminants Monitoring; Notice
[of NOW AC Arsenic Cost Working Group
meeting]. Vol. 66, No. 99, p. 28161. May
22, 2001. Available on web at
www.epa.gov/safewater/arsenic.html.
US EPA. 2001g. Arsenic Response-to-
Comments Document for W—99—16-IV. May
2001.
US EPA. 200lh. Meetings of the Arsenic Cost
Working Group of the National Drinking
Water Advisory Council; Notice of Public
Meeting. Vol. 66, No. 116, p. 32617. June
15, 2001.
US EPA. 2001i. EPA Science Advisory Board;
Notification of Public Advisory Committee
Meetings. Vol. 66, No. 127, p. 34924. July
2, 2001.
WH. 2001. Memorandum for the Heads and
Acting Heads of Executive Departments
and Agencies. Federal Register. Vol. 66,
No 66, pg. 7702. January 24, 2001.
Available on web at www.epa.gov/
safewater/arsenic.h tml.
US GS. 2000. Focazio, M., A. Welch, S.
Watkins, D. Helsel & M. Horn. A
retrospective analysis of the occurrence of
arsenic in ground water resources of the
United States and limitations in drinking
water supply characterizations. Water
Resources Investigations Report: 99-4279.
May 2000. Available on web at: http://
co.water.usgs.gov/trace/arsenic.
List of Subjects in 40 CFR Parts 141 and
142
•Environmental protection, Chemicals,
Indian lands, Intergovernmental
relations, Radiation protection,
Reporting and recordkeeping
requirements, Water supply.
Dated: July 13, 2001.
Christine Todd Whitman,
Administrator.
[FRDoc. 01-18093 Filed 7-18-01; 8:45 am]
BILLING CODE 6560-50-P
FEDERAL COMMUNICATIONS
COMMISSION
47 CFR Part 64
[CC Docket No. 98-67; DA 01-1555]
Provision of Improved
Telecommunications Relay Service
AGENCY: Federal Communications
Commission.
ACTION: Proposed rule.
SUMMARY: This document solicits
additional comment on the provision of
improved Telecommunications Relay
Service (TRS). Title IV of the Americans
with Disabilities Act (ADA) requires the
Commission to promulgate regulations
on TRS, to make available to Americans
with hearing or speech disabilities
telecommunications services that are
functionally equivalent to those
available to individuals without
disabilities.
DATES: Comments are due on or before
July 30, 2001 and reply comments are
due on or before August 6, 2001.
ADDRESSES: Federal Communications
Commission, 445 12th Street, S.W,
Washington, DC 20554.
FOR FURTHER INFORMATION CONTACT:
Dana Jackson, (202) 418-2247 (voice),
(202) 418-7898 (TTY). This document is
available to individuals with disabilities
requiring accessible formats (electronic
ASCII text, Braille, large print, and
audio) by contacting Brian Millin at
(202) 418-7426 (voice), (202) 418-7365
(TTY), or by .sending an email to
access@fcc.gov.
SUPPLEMENTARY INFORMATION: The
Bureau is issuing this document to seek
comment on WorldCom's Petition and
additional issues associated with IP
Relay. Comments already submitted in
response to WorldCom's petition will be
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