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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                   Federal Register/Vol. 66, No. 139/Thursday, July 19,  2001/Proposed Rules
                                                                      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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Federal Register/Vol. 66, No. 139/Thursday, July 19, 2001/Proposed Rules
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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                 Federal Register/Vol.  66, .No. 139/Thursday, July 19, 2001/Proposed Rules
                                                                    37621
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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 37622
Federal  Register/Vol. 66, No. 139/Thursday, July 19, 2001/Proposed Rules
 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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                  Federal Register/Vol. 66, No.  139/Thursday, July 19, 2001/Proposed Rules           37623
 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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Federal  Register/Vol. 66, No.  139/Thursday,  July  19,  2001/Proposed Rules
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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Federal Register/Vol.  66,  No. 139/Thursday, July 19, 2001/Proposed Rules
 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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Federal Register/Vol.  66, No.  139/Thursday, July 19, 2001/Proposed Rules
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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                   Federal Register/Vol.  66, No. 139/Thursday, July  19, 2001/Proposed Rules
                                                                          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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