Consideration of Other Regulatory
      Revisions for Chemical
  Contaminants in Support of the
  Six-Year Review of the National
Primary Drinking Water Regulations

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Office of Water
Office of Ground Water and Drinking Water (4606M)
EPA815-R-03-005
www.epa.gov/safewater
June 2003
                                       Printed on Recycled Paper

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                                                       EPA815-R-03-005
       Consideration of Other Regulatory Revisions for
          Chemical Contaminants in Support of the
                     Six-Year Review of the
        National Primary Drinking Water Regulations
                               June 2003
                 United States Environmental Protection Agency
                             Office of Water
                  Office of Ground Water and Drinking Water
                      Drinking Water Protection Division
                      Drinking Water Protection Branch
                   1200 Pennsylvania Avenue, NW (4606M)
                          Washington, DC 20460
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                             TABLE OF CONTENTS

List of Acronyms and Abbreviations	vi

1.0   Background  	1
      1.1 Purpose of the Six-Year Review	1
      1.2 Purpose of this Document	2

2.0   Compliance Monitoring and Reporting	3
      2.1 Issue Description	3
      2.2 Summary of Comments and EPA	3
             2.2.1  Flexibility of Monitoring Schedules 	3
             2.2.2  Waiver Issuance and Vulnerability Assessment  	5

3.0   Lead and Copper Rule Requirements  	6
      3.1 Issue Description	6
      3.2 Summary of Comments and EPA Responses	6
             3.2.1  Suggestions for Cost and Burden Reduction	6
             3.2.2  Sampling Methodology and Strategy  	7

4.0   Monitoring for Cyanides 	8
      4.1 Issue Description	8
      4.2 Summary of Comments and EPA Responses	9

5.0   Monitoring for Nitrites	10
      5.1 Issue Description	10
      5.2 Summary of Comments and EPA Responses	10

6.0   Monitoring and Public Notification for Fluoride	11
      6.1 Issue Description	11
      6.2 Summary of Comments and EPA Responses	11

7.0   Consumer Confidence Report and Public Notification Requirements 	12
      7.1 Issue Description	12
      7.2 Summary of Comments and EPA Responses	12

8.0   Re-Evaluation of Risk for Requiring NTNCWS Monitoring  	13
      8.1 Issue Description	13
      8.2 Summary of Comments and EPA Responses	13
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                     TABLE OF CONTENTS, continued...
REFERENCES  	15

APPENDIX	17
      Appendix Table 1: Implementation Issues Identified by Headquarters in the December
             12, 2000 Memo to Regions  	19
      Appendix Table 2: Additional Written and Verbal Implementation Issues Submitted by
             EPA Regions and States  	21
      Appendix Table 3: Implementation and Other Regulatory Revision Issues Submitted as
             Comments to the April 17, 2002 Federal Register Notice  	24
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 ASDWA
 BAT
 CCR
 CFR
 CMR
 CWS
 EPA
 EPTDS
 FR
 GUDI
 HQ
 ICC
 IOC
 LCCA
 LCR
 MCL
 mg/L
 NPDWR
 NTNCWS
 PN
 PWS
 RTC
 SDWA
 SMCL
 SMF
 SOC
 SWAP
 TNCWS
 USEPA
 VOC
 WQP
       List of Acronyms and Abbreviations
Association of State Drinking Water Administrators
Best Available Technology
Consumer Confidence Report
Code of Federal Regulations
Chemical Monitoring Reform
Community water system
United States Environmental Protection Agency
Entry point to the distribution system
Federal Register
Ground water under the direct influence of surface water
EPA Headquarters
Interstate carrier conveyance
Inorganic chemical
Lead Contamination Control Act
Lead and Copper Rule
Maximum Contaminant Level
Milligrams per liter
National Primary Drinking Water Regulation
Non-transient, non-community water system
Public Notification
Public water system
Return-to-C ompli ance
Safe Drinking Water Act
Secondary Maximum Contaminant Level
Standard Monitoring Framework
Synthetic organic chemical
Source Water Assessment and Protection
Transient Non-Community Water System
U.S. Environmental Protection Agency
Volatile organic chemical
Water quality parameter
Consideration of Other Regulatory Revisions
                       VI
                                                          June 2003

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1.0    Background

1.1 Purpose of the Six- Year Review

       Under the Safe Drinking Water Act (SDWA), the U.S. Environmental Protection Agency
(EPA) must periodically review existing National Primary Drinking Water Regulations
(NPDWRs) and, if appropriate, revise them.  This requirement is contained in section 1412(b)(9)
of the SDWA, as amended in 1996, which reads:

       The Administrator shall, not less often than every 6 years, review and revise, as
       appropriate, each national primary drinking water regulation promulgated under this
       title. Any revision of a national primary drinking water regulation shall be promulgated
       in accordance with this section, except that each revision shall maintain, or provide for
       greater, protection of the health of persons.

       To facilitate the quality and consistency of this regulatory review process, EPA
performed a series of analyses at the beginning of each review cycle, intended to target those
NPDWRs that are the most appropriate candidates for revision. The Agency plans to use
available, scientifically-sound data to make decisions regarding whether or not to revise a
regulation.  During each review cycle, EPA will review the following key information to make
decisions regarding regulatory changes:  health risk assessments; technology assessments; other
revisions related to implementation of the regulations; occurrence and exposure analyses; and
economic considerations.

       For its review of other regulatory revisions, EPA focused on issues that are not already
being addressed, or have not been addressed, through alternative mechanisms (e.g., as a part of a
recent or ongoing rulemaking). Where appropriate alternative mechanisms did not exist, EPA
considered these implementation-related concerns if the potential revision met the following
criteria:

       (1)     It indicated a potential change to an NPDWR, as defined under section 1401  of
              SDWA1;

       (2)     It was "ready" for rulemaking - that is, the problem to be resolved has been
              clearly identified and specific option(s) have been formulated to  address the
              problem; and

       (3)     It met at least one of the following conditions:

                     clearly improved the level of public health protection; and/or
1  The subject of the Six-Year-Review, as specified in section 1412(b)(9) of the SDWA, is "each national primary
drinking water regulation," as defined under section 1401 of the SDWA . Therefore, EPA has modified the above
criteria to clarify that revisions the Agency will consider are those "to an NPDWR, as defined under section 1401 of
SDWA" rather than "in the 40 CFR 141 requirements."
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                   represented a meaningful opportunity for cost savings while not lessening
                    public health protection.

1.2 Purpose of this Document

       In December of 2000, EPA Headquarters (HQ) circulated a memorandum to its Regional
offices requesting feedback on issues relating to the implementation of its drinking water
regulations. Although the memorandum specified a "potential set of issues" for consideration
(Appendix, Table 1), Regions were asked to identify any other known issues related to
regulatory implementation. In addition, the Association of State Drinking Water Administrators
(ASDWA) was asked to confer with the States regarding implementation issues that they felt
needed to be reviewed or addressed.

       The number and extent of responses from EPA Regions and States were limited. In
response to the memorandum and the request to the ASDWA, EPA received feedback from: nine
EPA Regions, seven States, and ASDWA. Of the written communications received, a few
discussed issues that have already been addressed in the recently published arsenic and
radionuclides NPDWRs (66 FR 6975, January 22, 2001 (USEPA,  2001); 65 FR 76707,
December 3, 2000 (USEPA, 2000b)), and others are being addressed through ongoing
mechanisms. This document summarizes the implementation issues that were discussed in this
written (and some verbal) feedback from EPA Regions and States (Appendix, Table 2). Copies
of these written communications, as well as the memorandum that was sent to Regions
requesting feedback, are available at the Six-Year Review [OW-2002-0012] Water Docket, U.S.
Environmental Protection Agency; 1301 Constitution Avenue, NW, EPA West, Room B-102,
Washington, DC 20460; (202) 566-2426 between 8:30 a.m. and 4:30 p.m. Eastern Time,
Monday through Friday, excluding Federal holidays.

       The regulatory implementation issues that EPA considered during the 1996-2002 review
cycle are summarized in this report.  In response to public comments received regarding the
April 17, 2002 Federal Register notice in which EPA announced its preliminary revise/not revise
decisions, this document has been amended to provide clarifications on Agency rationale and
findings regarding the various implementation-related issues that were discussed by EPA
Regions and States (67 FR 19030 (USEPA, 2002)). Specifically, EPA has added summary
tables to this document (see Appendix), which provide a concise depiction of the issues raised
and the Agency's current stance on these issues. Other clarifying language has also been added
where necessary, throughout the document.  The EPA Implementation Sub-Team Workgroup's
(consisting of EPA HQ and Regional representatives) positions regarding each of the issues  can
be found within each of the topical sections of this document.  In sections 2 through 8 of this
document, a background issue description is provided, followed by a more detailed summary of
the Region/State feedback, and EPA's positions on each of the issues raised.

       Although EPA received some additional comments (Appendix, Table 3) from the public
regarding implementation issues following the April Federal Register notice, most issues
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overlapped with those raised prior to the Agency's preliminary decisions.  For a summary of the
public comments regarding implementation issues, and EPA's response to those comments,
readers can reference the April 17, 2002, Federal Register notice, or they can obtain a copy of
the document: Public Comment and Response Summary for the Six-Year Review of National
Primary Drinking Water Regulations (USEPA, 2003).
2.0    Compliance Monitoring and Reporting

2.1 Issue Description

       In developing the NPDWRs, EPA established monitoring requirements for contaminants,
including frequency and location of sampling.  The Agency's general monitoring framework for
these chemical contaminants is referred to as the Standard Monitoring Framework (SMF).  This
framework consists of required compliance monitoring every three, six, and nine years,
depending on the occurrence of regulated contaminants, and the issuance of waivers by States.
EPA has allowed the use of grandfathered data for some contaminants, and has a process for
allowing States to issue waivers to public water systems (PWSs) for the regulated chemical
contaminants (see 40 CFR 141.23 and 141.24).

       Many commenters suggested that compliance monitoring schedules and waiver issuance,
as currently structured, provide inadequate flexibility, and/or are inconsistently applied across
different types of PWSs and different contaminant groups. Most commenters would like to see
more consistent application of the regulations.  Some commenters also expressed interest in
reducing recordkeeping and reporting requirements to alleviate the burden on States and PWSs.

2.2 Summary of Comments and EPA Responses

2.2.1 Flexibility of Monitoring Schedules

Comment Summary: Several commenters suggested that current monitoring requirements (and
more specifically, triggers for increased monitoring,  reduced monitoring, and routine
monitoring) provide inadequate flexibility, and/or are inconsistently applied across different
types of PWSs (e.g., ground water vs. surface water,  or community vs. non-community) and
different contaminant groups.  Several commenters stated that there is a need to have more
consistent application of the regulations, particularly for chronic contaminants where maximum
contaminant levels (MCLs) are based on lifetime exposure to contaminants. Related to this,
commenters suggested that, to conserve State and PWS resources, new contaminant monitoring
schedules should be coordinated with existing contaminant schedules in the SMF. Finally,
others commented that the new rules should allow for reductions in monitoring for a variety of
contaminants, particularly those determined to be chronic or naturally-occurring (e.g., arsenic
and fluoride), and that such contaminants should not need to be monitored quarterly.
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Agency Response:  The Agency agrees that consistency across regulations is desirable to the
extent that it does not jeopardize public health protection or the environment. As part of the
Advanced Notice of Proposed Rulemaking (ANPRM) for the Chemical Monitoring Reform
(CMR) (62 FR 36099, July 3, 1997 (USEPA, 1997a)), EPA considered some of these
consistency issues.  However, during the comment period for the CMR, stakeholders generally
indicated that the existing monitoring framework was sufficient.  Most State commenters
indicated that it would be too burdensome to adopt CMR. As a result, the Agency decided to
take no further action on the CMR. However, the Agency established an SMF which applies to
all of the regulated  chemical and radiological contaminants (except lead and copper). The new
chemical and radiological rules that EPA has promulgated (e.g., arsenic and radionuclides) are
coordinated with the SMF. The Agency made special efforts to ensure that the reduced
monitoring periods are in line with the three-year compliance periods in the SMF.

       EPA intends to consistently implement compliance determination provisions for
inorganic chemicals (lOCs), synthetic organic chemicals (SOCs), and volatile organic chemicals
(VOCs) for all non-transient, non-community water systems (NTNCWSs) and community water
systems (CWSs), as described in the preamble to the Final Arsenic Rule (66 FR 6975 at 6990,
January 22, 2001 (USEPA, 2001)). The rule requires compliance determinations to be based on
a running annual average. The  clarifications to compliance determinations for SOCs, lOCs, and
VOCs are based on the average of the initial MCL exceedance and any subsequent State-
required confirmation samples.  States have the flexibility to require confirmation samples and
more frequent monitoring, in addition to required quarterly samples. The average of the
exceedance and confirmation samples constitutes the first quarterly sample. Compliance with
the MCL is based on the average of the first quarterly sample and three additional samples over a
period of one year,  unless any one quarterly sample would cause the running annual average to
exceed the MCL. Then the system is out of compliance immediately.

       With respect to flexibility for States in determining reduced monitoring schedules:
although  the Agency understands the need for PWSs to reduce monitoring where possible, if a
PWS is exceeding an MCL, there is a public health threat and the PWS should monitor on a
quarterly basis or install treatment. Moreover, for an acute contaminant, such as nitrate, the
Agency believes that  regular monitoring is important to characterize any variations in
contaminant concentrations that may exceed levels of public health concern. Quarterly
monitoring is a tool for States and EPA to track non-compliance with MCLs, as well as to
encourage systems  to rectify the problem as expeditiously as possible. However, States have the
flexibility to evaluate situation-specific circumstances and reduce monitoring, and/or waive the
sampling requirements for any given contaminant after minimum criteria are met to demonstrate
that the system is reliably and consistently below the MCL and/or not vulnerable to
contamination.

       Commenters expressed interest in reducing recordkeeping and reporting requirements to
alleviate the burden on States and PWSs.  State-related reporting and recordkeeping
requirements are part of 40 CFR 142, and thus are outside the scope of the Six-Year Review.
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The subject of the Six-Year Review, as specified in section 1412(b)(9), is "each national primary
drinking water regulation."  The NPDWRs are found in part 141. Part 142 governs largely
procedural matters, such as primacy, variances and exemptions. While EPA can and does
periodically consider changes to the part 142 provisions, such review is not governed by section
1412(b)(9) and so is not part of the Six-Year Review protocol.

2.2.2  Waiver Issuance and Vulnerability Assessment

Comment Summary: Several commenters pointed to a need for broader flexibility in
determining not only the appropriate timing for contaminant monitoring, but also in identifying
which contaminants need to be monitored. Specifically, commenters indicated that systems
should not be required to monitor for contaminants that are not found in their geographic areas,
as based on previous monitoring results, source water assessment data, vulnerability
assessments, and hydrogeology.  Commenters also indicated the need for flexibility in setting the
vulnerable times for pesticide monitoring, based on area-specific temporal patterns.

Agency Response: EPA believes that the existing waiver provisions in the SDWA regulations
give States sufficient flexibility to reduce or potentially eliminate monitoring of a chemical
contaminant, where appropriate.  States that have primacy for the drinking water regulations are
responsible for their waiver programs and can grant waivers if a particular pesticide or herbicide
has not been previously used, manufactured, stored, transported, or disposed in the area; a
system's source water is not susceptible to contamination from the chemical; or the State has
determined the system is not vulnerable.  The State can grant waivers for individual
contaminants, a group of contaminants, or issue an area-wide waiver (see 40 CFR 141.23 (b)
and (c), and 141.24 (f) and (h)). In addition, States can adopt alternative monitoring  strategies,
as long as the approach is as stringent as the Federal requirements (USEPA, 1997b).

       With respect to flexibility in determining vulnerable periods for pesticides: the Agency
notes  that statistical studies of sampling strategies in surface water (Battaglin and Hay, 1996)
have shown that incorporating sampling during spring and early summer runoff periods provides
a more accurate representation of annual occurrence than random quarterly sampling (that may
avoid these months). Ground water studies (Pinsky et a/.,  1997) suggest that the more
vulnerable ground water settings also show peaks during these periods. EPA is currently looking
at the vulnerability assessment issue through another mechanism.  The Agency will prepare a
comprehensive report on PWS vulnerability to the range of potential drinking water
contaminants.  The comprehensive report will present approaches to applying vulnerability
concepts to drinking water programs.
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3.0    Lead and Copper Rule Requirements

3.1 Issue Description

       EPA published revisions to the Lead and Copper Rule (LCR) on January 12, 2000 (65 FR
1950 (USEPA, 2000a)). The revisions were designed to streamline monitoring and reporting
burdens for PWSs and State drinking water agencies.  As part of these revisions, EPA added
language to the LCR which clarifies requirements and corrects oversights in the original rule.
The revisions do not affect the lead and copper maximum contaminant level goals, action levels,
or other basic regulatory requirements for monitoring of lead and copper at the tap and
optimizing corrosion control.

       Commenters made numerous suggestions for further streamlining the monitoring,
recordkeeping, and reporting requirements of the LCR. As noted above, State recordkeeping and
reporting requirements  are outside the scope of the Six-Year Review, as they are part of 40 CFR
142.

3.2 Summary of Comments and EPA Responses

3.2.1  Suggestions for Cost and Burden Reduction

Comment Summary: Commenters made several suggestions on ways to reduce burden to PWSs
and States, including:  reducing monitoring requirements, providing monitoring waivers,
discontinuing the copper NPDWR or changing it to a secondary standard, and moving lead and
copper onto the SMF schedule of sampling once every 3/6/9 years. Commenters suggested that
EPA review the NTNCWS sampling and mitigation requirements to allow for meaningful
application of the rule at these systems.

Agency Response:  EPA reduced the monitoring requirements for lead and copper in the January
2000 revisions to the LCR and does not believe that further reductions, particularly for copper,
can be made without undermining the level of public health protection, which is prohibited by
SDWA. Regarding monitoring requirements for lead in the LCR, the Agency believes that any
further reductions in monitoring would not provide adequate public health protection for
members of sensitive populations (i.e., pregnant women and children six years of age or
younger). However, if new peer-reviewed scientific information becomes available, it will be
considered.2
2 Peer-reviewed data are studies/analyses that have been reviewed by qualified individuals (or organizations) who
are independent of those who performed the work but who are collectively equivalent (i.e., peers) to those who
performed the original work. A peer review is an in-depth assessment of the assumptions, calculations,
extrapolations, alternative interpretations, methodology, acceptance criteria, and conclusions pertaining to the
specific major scientific and/or technical work products and of the documentation that supports them (USEPA,
2000c).
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       EPA considered special allowances forNTNCWSs as part of the January 2000 revisions
to the LCR.  However, EPA decided at that time to retain the original requirement because the
Agency did not have sufficient scientific data that would support reasonable alternatives for all
NTNCWSs.

       The issues raised by the commenters were already  considered by the Agency for the
January 2000 revision to the LCR. At this time, the Agency has not received significant new
information that suggests it is appropriate to revisit the LCR requirements. The Agency
recognizes that the LCR is a challenging rule, but continues to believe that the public health
objective addressed by the rule is as important and essential today as it was when the rule was
first promulgated. However, the Agency recognizes that more research would be useful to
obtain additional information that could be utilized to address some of the issues associated with
the implementation of this rule.

3.2.2  Sampling Me thodology and Strategy

Comment Summary: Commenters suggested that the current sampling strategy limits a PWS
operator's ability to identify sampling sites. The commenters noted that the current "tiered
approach" to sampling plans, which is designed to target sites likely to have high levels of lead at
the tap, has raised public concern about why locations where children are more likely to be
exposed to lead and  copper (such as schools and day care centers) are not better sampling points.
In addition, a commenter indicated that the current corrosion control strategies  are marginally
effective at preventing particulate lead  and copper from entering the water supply and
recommended that EPA consider methods  for mitigating the release of insoluble components
from plumbing fixtures.  Commenters also recommended that water systems be allowed to
conduct water quality parameter (WQP) monitoring in lieu of continued lead and copper tap
monitoring.

Agency Response: The Agency considered modifying the sampling protocol as a part of the
January 2000 revisions to the LCR but did not believe that there was sufficient  scientific data on
which to base a revised protocol.  EPA currently believes that regularly utilized household taps
are the most appropriate sampling locations to determine whether consumers are being exposed
to high levels of lead and copper in drinking water. If a PWS does not have enough sites that
meet the tiering criteria, the January 2000 revisions to the  LCR provide PWSs with the authority
to complete their sampling pool with representative sites throughout the  distribution system. At
this time, EPA does  not have any new information that demonstrates that sampling at other
locations (which might be more within the control of the PWS operator), or that modifying the
sampling protocol would maintain the same level of public health protection. However, if new
peer-reviewed scientific information becomes available, it will be considered.

       Regarding the suggestion that schools or day-care centers may be better sampling sites,
the Agency notes that the LCR is designed to address system-wide problems with lead and
copper contamination. The rule does not specifically target particular structures, such as
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schools, but rather contains a monitoring protocol designed to ensure that the overall levels of
lead and copper system-wide are minimized. Once optimal treatment is implemented, any
remaining problems with elevated lead levels in schools may be due to plumbing, coolers, or
other materials in the building.  These potential sources of lead in schools are of concern and for
this reason are explicitly addressed under the provisions of the Lead Contamination Control Act
of 1988 (LCCA) (sections 1461 to 1465  of SDWA). The LCCA directed EPA to  publish a
guidance manual and testing protocol to assist States and schools in identifying sources and
determining the extent of lead contamination in school drinking water and, if necessary, in
remedying such contamination. In January  1989, the Agency published and distributed the
guidance manual, "Lead in School's Drinking Water," to States and schools. In 1994, the
Agency updated and revised the guidance manual entitled "Lead in Drinking Water in Schools
and Non-residential Buildings." A copy of this manual may be obtained from the Safewater
website http://www.epa.gov/safewater/consumer/leadinschools.html. In addition, the LCCA
imposed a ban on the manufacture and sale of water coolers that are not lead free. The LCCA
requirements are independent of the NPDWRs and therefore are not addressed under the Six-
Year Review process. However, the Agency is continuing to work with schools and States to
address problems dealing with lead in school drinking water.

       EPA recognizes that the release of insoluble particulate material containing lead and
copper can be an issue in some water systems. While more research may be of interest to
improve optimization of corrosion control approaches with respect to this source,  EPA expects
that evaluations and pilot studies by water systems should include testing and consideration of
the relative effectiveness of different treatments towards parti culate release in systems for which
it is important.

       EPA does not feel that WQP monitoring is an appropriate substitute for lead and copper
tap monitoring.  Significant treatment changes or water chemistry disturbances (such as new
water sources, major pH/coagulation changes, disinfectant changes, or seasonal water/treatment
changes) can influence the effectiveness of corrosion control, which in turn will require
appropriate adjustments of treatment. Current regulations require water systems to continue
monitoring lead and copper levels to assure that water quality changes adversely affecting the
presence of these contaminants in the drinking water are detected and to  assure that appropriate
adjustments to maintain optimal corrosion control are made.
4.0    Monitoring for Cyanides

4.1 Issue Description

       EPA published the current NPDWR for cyanide on July 17, 1992 (57 FR 31776 (USEPA,
1992)).  Under this regulation, PWSs may receive a waiver for cyanide monitoring. Without a
waiver, ground water systems are required to monitor for cyanide once every three years, while
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surface water systems are required to monitor annually. All samples must currently be collected
from the entry point to the distribution system (EPTDS).

       Comments regarding cyanide addressed the possibility of raw water monitoring due to
possible formation of cyanogen chloride after chlorination. Other commenters identified the
need for a rule revision relating to an error in the Best Available Technology (BAT) specified for
cyanide in the Code of Federal Regulations (CFR).

4.2 Summary of Comments and EPA Responses

Comment Summary: A variety of comments were received on the cyanide issue, ranging from
those that believe that no further expansion of cyanide monitoring is needed to a commenter who
believes monitoring of cyanide and nitrites is the "second highest priority." It was suggested that
the Agency consider requiring cyanide monitoring in raw water, since monitoring treated water
(i.e., after chlorine disinfection) provides no useful data on the presence of cyanogen chloride
formation after chlorination. One commenter believed the treatment of raw water containing
cyanide should be addressed as a regional issue, particularly for many western States. Another
commenter expressed concern that monitoring for cyanide in raw water would "skew the
analysis of risk reduction" and would potentially take away the ability to identify contaminant
levels to which consumers are actually exposed. This commenter also recommended that it
might be better to "use raw water monitoring as a screen, and only require treated water testing
when there is a detect." One commenter pointed out that the BAT for cyanide had been clarified
as being alkaline chlorination in an EPA advisory, and should be changed in the regulation.

Agency Responses:  Regarding cyanide monitoring issues:  EPA has not received any new data
and recognizes that more research may be needed to determine the extent of the problem. If
further research indicates  this is a widespread and  high-priority issue, then the Agency may
consider it in an upcoming rulemaking (e.g., Distribution System Rule).  EPA suggests that
PWSs and States with cyanide and/or cyanogen chloride problems should take advantage of
information in the "Public Water System Warning" Memo (USEPA, 1994), which deals directly
with this issue.  In addition to the required monitoring, States also have the flexibility to monitor
raw source water samples for cyanide as well as monitor for cyanogen chloride in the
distribution system.

       EPA acknowledges that in 40 CFR 141.62(c), the BAT incorrectly specifies "chlorine"
for cyanide. It should specify "alkaline chlorination."  EPA plans to correct this error through a
technical amendment to the  cyanide NPDWR in the future. In the meantime, water systems and
States should continue to be guided by the small system compliance technology list published
September 1998, which correctly lists the technology as alkaline chlorination and the "Public
Water System Warning" Memo (USEPA, 1994; USEPA, 1998).
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5.0    Monitoring for Nitrites

5.1 Issue Description

       EPA published the current NPDWR for nitrite on January 30, 1991 (56 FR 3526
(USEPA, 1991)), establishing an MCL of 1.0 mg/L, and the requirement that all PWSs must
monitor for nitrite at each EPTDS.  States cannot issue waivers for nitrite monitoring. The
federal regulations required that one nitrite sample be collected in the 1993 to 1995 compliance
period.  If results were less than l/2 the MCL, future nitrite monitoring was left to the discretion
of the State. Many States do require their PWSs to monitor for nitrite once every three years, on
the same monitoring schedule as all other lOCs (except nitrate, which, based on monitoring
results, is required quarterly or annually for all systems). As with cyanide monitoring, nitrite
samples are required by the federal regulations to be collected at the EPTDSs.  However, for
PWSs which have a sufficiently high level of ammonia in their water, nitrite may be found at
elevated levels in distribution systems, not at the EPTDSs. In the presence of a sufficient
amount of a strong oxidant (e.g., chlorine dioxide, free chlorine, or ozone), nitrite can be
oxidized to nitrate.

       Comments regarding nitrite monitoring included requests for more flexibility in
determining sampling location.  With more flexibility, commenters suggested that States could
make situation-specific adjustments to monitoring location based on monitoring results or
concern over elevated nitrite levels due to chloramination.

5.2 Summary of Comments and EPA Responses

Comment Summary: Several commenters recommended that EPA provide States with the
flexibility to require routine nitrite monitoring in the distribution system (rather than the EPTDS)
when it appears to be the most appropriate location for that contaminant, and to require raw
water sampling for ammonia when appropriate. Commenters believe that changing the sampling
point from the EPTDS to some point in the distribution system will  affect PWSs  with high levels
of ammonia in raw water, especially if treatment installation is required. Another commenter
recommended that EPA consider requiring distribution monitoring if an entry point result is
greater than 50 percent of the MCL.  Other commenters reported that chloramination may
increase the likelihood of finding elevated nitrite levels in distribution systems, and that it would
therefore seem reasonable to require monitoring in finished water where nitrite levels would be
highest.

Agency Responses: As stated above, although free chlorine and other strong oxidant
disinfectants will usually oxidize nitrite to nitrate in a water sample, EPA believes that this may
not occur in all chlorinated water supplies. This issue was addressed by the Agency in the
Federal Register notice entitled Analytical Methods for Chemical and Microbiological
Contaminants and Revisions to Laboratory Certification Requirements (64 FR 67449, December
1, 1999 (USEPA, 1999)).  Some research is underway, as part of the Distribution System Rule
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development, to look at the nitrification issue. However, EPA recognizes that more
data/research may be necessary. If further research indicates that this is a widespread issue, the
Agency may consider it in an upcoming rulemaking.
6.0    Monitoring and Public Notification for Fluoride

6.1 Issue Description

       Fluoride is unique as a drinking water contaminant because of its beneficial effects at low
level exposures, and because it is voluntarily added to some drinking water systems as a public
health measure for reducing the incidence of cavities among the treated population. EPA is
currently reviewing the health effects of fluoride.

       As part of the review of possible "other regulatory revisions," EPA has identified two
possible issues related to the regulation of fluoride in  drinking water. The first issue is related to
the timeliness of the public notification requirement associated with exceedances of the
secondary maximum contaminant level (SMCL). PWSs are required to notify the public if the
fluoride SMCL is exceeded within 12 months of the initial exceedance.

       The second pertains to the issue that current monitoring for fluoride may not be sufficient
for systems that fluoridate. Under the current regulations, ground water systems are required to
monitor for fluoride once every three years and surface water systems to monitor annually.  This
monitoring scenario is consistent with monitoring requirements for other naturally-occurring
lOCs (other than lead and copper) but does not consider the addition of fluoride for beneficial
purposes that occurs at some water systems.

6.2 Summary of Comments and EPA Responses

Comment Summary: Commenters expressed concern about the timeliness of the public
notification (PN) requirement  associated with exceedances of the SMCL. Currently, as stated
above, PWSs that exceed the fluoride SMCL of 2.0 mg/L are required to notify their customers
within 12 months of the exceedance. Concern has been raised that this requirement is not
sufficiently timely since dental fluorosis occurs as a result of exposure to high levels of fluoride
while the tooth enamel is being laid down. Waiting 12 months to provide PN means that young
children may be exposed to high levels of fluoride during the time at which they are most
vulnerable.

       Commenters raised concern that the current monitoring for fluoride may not be sufficient
for systems that fluoridate. More frequent monitoring may be necessary for systems that
fluoridate because fluoride does not degrade or decrease in concentration in the distribution
system (unlike chlorine).  In particular, concentrations of fluoride may increase above acceptable
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levels where evaporation of water may occur, such as in a storage tank.  Thus, commenters are
suggesting that more frequent monitoring may be appropriate to ensure that this does not occur.

Agency Response:  Although PN requirements are not part of the NPDWR for fluoride, and are
thus outside of the scope of this review, EPA will consider revisions to the fluoride PN
requirements only if it becomes appropriate to revise the fluoride NPDWR in the future. As
noted above, EPA is currently evaluating the health effects of fluoride and will reconsider
whether to revise the fluoride NPDWR as part of the next Six-Year Review once the health
effects review is completed. Similarly, when EPA reconsiders the fluoride NPDWR based on
the health effects review, EPA will consider the suggestion that more frequent monitoring may
be necessary for systems that fluoridate because fluoride does not degrade or decrease in
concentration in the distribution system.
7.0    Consumer Confidence Report and Public Notification Requirements

7.1 Issue Description

       EPA requires CWSs to develop annual drinking water quality reports for distribution to
their customers. Consumer Confidence Report (CCR) and PN requirements are national in
scope, with CCR issues affecting only CWSs, and PN issues affecting all PWSs. Changes to
CCR and PN requirements affect State drinking water agency oversight and compliance
determination activities, and affect the level of reporting burden for PWSs nationwide. CCR
requirements do not apply to NTNCWSs and transient, non-community water systems
(TNCWSs).

7.2 Summary of Comments and EPA Responses

Comment Summary:  Several commenters believed that CCR language requirements are too
prescriptive, and do not provide States with enough flexibility. Commenters believed that EPA
should review the CCR requirements to ensure that flexibility is retained.  Some commenters
expressed concern that the inclusion of mandatory language reduces the "readability" of the
document for  the general public. Commenters also believed that CCR and PN requirements
should be consistent with one another, and that PN requirements  should be simplified, or even
eliminated, because the PN requirements generate additional paperwork and create unnecessary
violations that have no impact on public health.

Agency Response:  The Agency does not consider the recently published CCR and PN Rule
requirements to be part of the NPDWRs,  as defined under section 1401 of SDWA. Moreover,
these rules have only been recently promulgated or revised.  As a result, many States are just
beginning the adoption and implementation phases of the new rules. Therefore, revisions to the
rules at this time would not be appropriate.
Consideration of Other Regulatory Revisions        12                                  June 2003

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8.0    Re-Evaluation of Risk for Requiring NTNCWS Monitoring

8.1 Issue Description

       In general, NTNCWSs are subject to the same monitoring and reporting requirements as
CWSs. Some commenters suggested that EPA conduct risk and exposure assessments to
determine whether NTNCWSs should continue to be regulated in the same manner as CWSs
(which tend to serve a larger proportion of the population over longer time periods).

8.2 Summary of Comments and EPA Responses

Comment Summary:  Some commenters suggested that EPA conduct additional research on the
amount and percentage of water consumed at NTNCWSs and establish a risk assessment for
individuals using these types of systems.  Others recommended that EPA work with States and
other stakeholders to develop a consistent approach to regulating NTNCWSs. One specification
was that EPA needs to review non-acute contaminants in order to assure that the limited
exposure associated with NTNCWSs actually presents a health risk worthy of regulation.

Agency Response:  NTNCWSs are traditionally regulated for chronic contaminants.  However,
the Agency is currently evaluating risk and exposure as they pertain to NTNCWS monitoring
requirements. This review will not be completed in time for this Six-Year Review process.
Until all the issues have been identified and specific options have been formulated, it will not be
clear if a revision to regulations is indicated.
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REFERENCES
Battaglin, W., and Hay, L. 1996. Effects of sampling strategies on estimates of annual mean
       herbicide concentrations in Midwestern rivers. Environmental Science and Technology.
       v. 30, p. 889-896.

Pinsky, P., M. Lorber, K. Johnson, B. Kross, L. Burmeister, A. Wilkins, and G. Hallberg. 1997.
       A study of the temporal variability of atrazine in private well water. Environmental
       Monitoring and Assessment,  v. 47, p. 197-221.

United States Environmental Protection Agency (USEPA).  1991.  National Primary Drinking
       Water Regulations - Synthetic Organic Chemicals and Inorganic Chemicals; Monitoring
       for Unregulated Contaminants; National Primary Drinking Water Regulations
       Implementation; National Secondary Drinking Water Regulations;  Final Rule. Federal
       Register. Vol. 56, No. 30. p. 3526,  January 30,  1991.

USEPA.  1992.  Drinking Water; National Primary Drinking Water Regulations - Synthetic
       Organic Chemicals and Inorganic Chemicals; National Primary Drinking Water
       Regulations Implementation; Final Rule. Federal Register. Vol. 57, No.  138. p. 31776,
       July 17, 1992.

USEPA.  1994. Public Water System Warning:  Cyanide. Memo from William R.  Diamond,
       Acting Director of Drinking Water Standards Division, Office of Ground Water and
       Drinking Water. March 7, 1994.

USEPA.  1997'a. Drinking Water Monitoring requirements for Certain Chemical
       Contaminants-Chemical Monitoring Reform (CMR) and Permanent Monitoring Relief
       (PMR); Proposed Rule. Federal Register.  Vol. 62, No. 128.  p. 36099-36136, July 3,
       1997.

USEPA.  1997b. Alternative Monitoring Guidelines.  EPA 816-R-97-011. August 1997.

USEPA.  1998.  Small System Compliance Technology List for Non-Microbial Contaminants
       Regulated Before 1996. EPA Report 815-98-002. September 1998.

USEPA.  1999.  Analytical Methods for Chemical and Microbiological Contaminants and
       Revisions to Laboratory Certification Requirements.  Federal Register.  Vol. 64, No.
       230. p. 67449,  December 1, 1999.

USEPA. 2000a. National Primary Drinking Water Regulations for Lead and Copper; Final
       Rule. Federal Register. Vol. 65, No. 8.  p. 1950-2015, January 12, 2000.
Consideration of Other Regulatory Revisions        15                                  June 2003

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USEPA.  2000b. National Primary Drinking Water Regulations; Radionuclides; Final Rule.
      Federal Register.  Vol. 65, No. 236. p. 76707-76753, December 3, 2000.

USEPA.  2000c. Science Policy Council Handbook: Peer Review, 2nd Edition. EPA Report 100-
      B-00-001. Office of Science Policy, Office of Research and Development. December
      2000.

USEPA.  2001. National Primary Drinking Water Regulation; Arsenic and Clarifications to
      Compliance and New Source Contaminants Monitoring; Final Rule.  Federal Register.
      Vol. 66, No. 14.  p. 6975-7066, January 22, 2001.

USEPA.  2002.  National Primary Drinking Water Regulations - Announcement of the Results
      of EPA's Review of Existing Drinking Water Standards and Request for Public
      Comment; Proposed Rule. Federal Register.  Vol. 67, No. 74. p. 19030, April 17, 2002.

USEPA.  2003. Public Comment and Response Summary for the Six-Year Review of National
      Primary Drinking Water Regulations. EPA 815-R-03-001.  Final. June 2003.
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                       APPENDIX
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         The following tables provide a brief summary of the major implementation issues that
  were identified by EPA HQ's, EPA Regions and States, along with EPA's general findings
  related to each issue.
             Appendix Table 1:  Implementation Issues Identified by Headquarters
            	in the December 12, 2000 Memo to Regions	
 Implementation
      Issues
     Commenter(s)
        Findings
   Recommended Action
Monitoring for
Cyanide
Two Regions - Need more
data.
One Region - No. 3
Priority.
One State - Did not support.
One State - Need more data.
One association - Allow
State flexibility to require if
necessary.
Place in the "Need More
Research" Box.
OR
Allow State flexibility to
require source water samples
but not mandatory
monitoring.

POSSIBLE Priority
Need more data or research to
determine if this is a big issue.
If further research indicates this
is an issue. Possibly address in
an upcoming rule (e.g., Dist.
System Rule).
Monitoring for
Nitrites
One Region - No. 2 Priority.
One Region - Supports
distribution system
monitoring.
One Region - Chlorine
residual oxidizes nitrite and
systems should not be
required to monitoring.
One State - Need more data.
One State - Supports.
One association - Supports
but also had some State
support for reducing
frequency.
One State- Require dist.
system samples if EPTDS is
>50% MCL.
One Region - Need more
data, but would support.
One State - Allow reduced
monitoring (SMF).
Place in the "Need More
Research" box.
OR
Allow State flexibility to
require distribution system
samples but not mandatory
monitoring.

POSSIBLE Priority
Some research is underway but
need more data or research. If
further research indicates this is
an issue. Possibly address in
an upcoming rule (e.g., Dist.
System Rule).
Pesticide Monitoring
One Region - Important to
tailor monitoring
requirements.
One Region - Support.
One State - Agree with
tailored monitoring but
difficult to implement.
One State - Compliance
should be based on annual
exposure, not one sample
Conceptually good idea but
implementation road block.
No further action
recommended.
  Consideration of Other Regulatory Revisions
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                                           June 2003

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             Appendix Table 1:  Implementation Issues Identified by Headquarters
            	in the December 12, 2000 Memo to Regions	
 Implementation
      Issues
     Commenter(s)
        Findings
                              Recommended Action
                     during vulnerable period.
                     But would like flexibility to
                     require targeted monitoring.
                     One association - Support
                     flexibility but not reg's.
                     One Region - Agree, but
                     difficult to implement.
Period of compliance
                           Taken care of in Arsenic and
                           Radionuclides Rules.
                            No further regulatory action
                            required.
Waiver guidance
One Region - No comments.
One Region - Supports use
of Source Water
Assessment and Protection
(SWAP).
One State - Supports use of
SWAP.
One association - Not a
priority.
One Region - Not a priority.
Program in place and
operational. No action
necessary. Existing tools are
being used.
                            No further regulatory action
                            required.
New system/source
monitoring
                           Resolved in Arsenic and
                           Radionuclides Rules.
                            No further regulatory action
                            required.
PN for Fluoride
Secondary Standard
One Region - No. 1 priority
(believe national problem).
One Region - Current
requirement adequate.
One State - Seems to prefer
only one standard at SMCL.
One State - Supports Tier 2
for SMCL violations
(but notification close to
time of occurrence).
One association - Do not
support.
One Region - Defer to
health effects team.
One State - Does not
support federal regulation.
Potential national issue -
priority unclear.
                            Evaluate if fluoride selected for
                            revision.
  Consideration of Other Regulatory Revisions
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                                            June 2003

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Appendix Table 2: Additional Written and Verbal Implementation Issues
Submitted by EPA Regions and States
Implementation Issues
Commenter(s)
Findings
Recommended Action
40 CFR 141 (System requirements)
Violation determination
Multiple entry points
Provide regulatory clarification
Consistent Compliance Monitoring
Triggers
Frequency - increased, routine,
reduced
Simplify for all source, cont,
system size, etc
 Allow monitoring at locations
other than EPTDS




Simplify Monitoring for IOC,
SOC, and VOC
Base on Health Risks
More prescriptive language to
assist in enforcement of
monitoring
 Allow annual monitoring for
lOCs that exceed the MCL
Require monitoring for seasonal
Transient Non-Community Water
Systems (TNCWS) prior to
opening (more of an issue for
microbials)
New System/Source Monitoring
Requirements
No deadline to complete
SWAPS
Regulatory Method Detection
Limits's (MDLs) > trigger levels?
(primarily SOCs - some States see
this and some do not)




One Region
Two States

Two Regions
Two States
One association


One State







One Region
One State


One State

Three Regions




One Region
Two States


Two Regions






Resolved in Arsenic and
Radionuclides Rule for all
chem/rads.
HIGH Priority but no new
information provided since
CMR dismissed. Also, most
States have dismissed CMR as
too much burden.

Monitoring at EPTDS was
addressed in Arsenic
preamble. State may
designate an alternate
sampling location if approved
in primacy package.


These concepts already
covered above - like CMR
issues.



HIGH Priority




Resolved in Arsenic and
Radionuclides Rule (Only for
Chems/Rads, not for Pb/Cu),
but most States have program.
Resolved in workgroup - and
decided to leave it alone
because there have been
memos and some guidance to
address this. No new
information provided to
resolve issue.
No further action needed.


No further action on CMR
related issues.




Remaining high priority
issues - keep in mind for
future rule making.





No further action on CMR
related issues.




Possibly revise in a future
rule (e.g., Total Coliform
Rule (TCR) revisions).


No further regulatory
action required at this time.


No further action
necessary at this time.





Consideration of Other Regulatory Revisions
21
June 2003

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Appendix Table 2: Additional Written and Verbal Implementation Issues
Submitted by EPA Regions and States
Implementation Issues
Revise PN language, CCR
Requirements and notification
requirements
Revise Lead and Copper Rule
Monitoring requirements and
sampling locations
High lead source water
Systems w/ 1-4 taps?
 Allow waivers
Make Copper- Action Level
Revise optimization
requirements
Include lead and copper in SMF
Reevaluate risk of requiring
NTNCWS to monitor for all
chronic contaminants
Evaluate Phthalate "false
positives"
Extend GUDI (Ground Water
Under Direct Influence)
determination deadline
Eliminate POU/POE (Point-of-
Use/Point-of-Entry) treatment
alternate
Define Consecutive Systems
 M/DBP - chlorine residual as it
moves through dist. system
Commenter(s)
One Region
Two States
One association
One Region
Three States
One association
Two Regions
Three States
One association
Two Regions
One State
One association
One State
One State
One Region
Findings
Refer to Chem/Rad Team for
evaluation.
Resolved in workgroup
discussion to leave it alone;
most of these issues were
addressed in the Pb/Cu Minor
Revisions rule (one way or
another) and no new data has
been presented to merit
reopening.
HIGH Priority
Consistency issue.
HIGH Priority
Not a priority. Extending
deadline is not more
protective of public health.
Evaluate in future rules.
Workgroup decided that we
have no new information to
evaluate to resolve.
Recommended Action
Evaluate in Chem/Rad
Team Vehicle. Outside
scope of Six-Year Review
because not an NPDWRs.
No regulatory action
required at this time; EPA
placed in data gaps
category to research LCR
implementation issues
Being evaluated by a
separate workgroup.
Use laboratory
certification newsletters to
remind laboratories of
problem. Possibly address
in a future methods update
rule.
No regulatory action at this
time.
Keep in mind for
evaluation in future rules.
UseofPOUs(Point-of-
Use) is being evaluated by
a separate workgroup.
FACA (Federal Advisory
Committee Act)
recommendation that EPA
address in LT2ESWTR
(Long Term 2 Enhanced
Surface Water Treatment
Rule).
Consideration of Other Regulatory Revisions
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June 2003

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Appendix Table 2: Additional Written and Verbal Implementation Issues
Submitted by EPA Regions and States
Implementation Issues
Commenter(s)
Findings
Recommended Action
40 CFR 142 (State Primacy)
State Specific Monitoring Waivers
Use SWAP'S for vulnerability
assess
 Allow region to issue waivers
Allow State wide waivers
Revise Primacy Requirement
Make less prescriptive
Data reporting
Limit reporting to critical data
elements
Have SDWIS operational within
one month after FR
Consistent reporting criteria for
all similar rules
One Region
One State
One State
One Region
Two States
One association
Outside scope of Six- Year
Review because not an
NPDWR requirement.
Outside scope of Six- Year
Review because not an
NPDWR requirement.
Outside scope of the Six- Year
Review because part 142 - can
be addressed through an
alternative mechanism.
No further regulatory
action required.
Evaluate in future rules.
Referred to Strategic
Information Plan -
Stakeholder meeting held
March 8-9, 2001 in
Washington, DC.
Non-regulatory (EPA guidance)
Definitions
Return-to-Compliance (RTC)
Compliance periods
 NTNCWS - # served
No specific provisions for
interstate carrier conveyances
(ICCs)inl41
PWS and apartments
Reliably and consistently below
MCL
Implementation Guidance (IG)
Finish IG within one week of
final rule
One Region
One State
One association
One State
The Region and association
strongly prefer regulatory
language as opposed to
guidance. BUT also want
State flexibility.
Address RTC and compliance
periods in strategic plan for
reporting requirements.
Enforcement of these may be
problematic.
Leave NTNCWS and
apartment PWS issues up to
States. EPA guidance
sufficient.
Not a Six-Year Review issue.
Refer to appropriate office.
Refer to Workgroup in
place - Regions and States
involved.
Generally occurs 60 days
after a final rule.
Consideration of Other Regulatory Revisions
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June 2003

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         Appendix Table 3:  Implementation and Other Regulatory Revision Issues
            Submitted as Comments to the April 17, 2002 Federal Register Notice
        Implementation Issues
    Commenters
    Summary of EPA Responses
 Consistent Compliance Monitoring
    Use SMF
One association
One State
The SMF, established by EPA, applies to
all of the regulated chemical and
radiological contaminants (except lead
and copper).  In addition, the new
chemical and radiological rules are
coordinated with the SMF.
 Simplify Monitoring for IOC, SOC,
 and VOC
     Consistent language for lOCs with
     VOC and SOC language from
     Arsenic Rule
Two associations
One State
EPA intends to consistently implement
compliance determination provisions for
lOCs, SOCs, and VOCs for all
NTNCWSs and CWSs.
 Public Notification and Consumer
 Confidence Report
     PN and CCR should be considered
     under the Six-Year Review
One State
The CCR and PN Rules are not
considered to be part of the NPD WRs, as
defined under section 1401 of the
SDWA.
 Revise Lead and Copper Rule
     Release of insoluble components

     Use Water Quality Parameters as
     indicators/surrogate monitoring
One association

One association
One utility
    Evaluations and pilot studies by
    water systems should include testing
    and consideration of the relative
    effectiveness of different treatments
    towards paniculate release in
    systems for which it is important.
    The Agency believes that the
    existing protocols as prescribed in
    the LCR, remain necessary and
    appropriate.
    EPA has placed LCR in data gaps
    category to research implementation
    issues.
 Fluoride
     Do not require frequent monitoring
     for systems that fluoridate
     All fluoride issues should be
     determined at the local level
One association
EPA is currently evaluating the health
effects of fluoride and will reconsider
whether to revise the fluoride NPDWR as
part of the next Six-Year Review once
the health effects review is completed.
Consideration of Other Regulatory Revisions
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                            June 2003

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                                                                 EPA 815-R-03-005

Consideration of Other Regulatory Revisions for Chemical Contaminants in  Support of
             the  Six-Year Review  of the National Primary Drinking Water Regulations

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