[Federal Register Volume 66, Number 174 (Friday, September 7, 2001)]
[Proposed Rules]
[Pages 46928-46935]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-22522]



[[Page 46927]]

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Part IV





Environmental Protection Agency





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40 CFR Part 141



National Primary Drinking Water Regulations: Minor Revisions to Public 
Notification Rule and Consumer Confidence Report Rule; Proposed Rule

  Federal Register / Vol. 66, No. 174 / Friday, September 7, 2001 / 
Proposed Rules  

[[Page 46928]]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 141

[FRL-7050-8]
RIN 2040-AD06


National Primary Drinking Water Regulations: Minor Revisions to 
Public Notification Rule and Consumer Confidence Report Rule

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: Today's action proposes to make specific changes to the health 
effects language for di(2-ethylhexyl) adipate (DEHA) and di(2-
ethylhexyl) phthalate (DEHP) in the Public Notification (PN) Rule (May 
4, 2000, 65 FR 26020) and the Consumer Confidence Report (CCR) Rule 
(August 19, 1998, 63 FR 44511). EPA is also clarifying the proper use 
of the Integrated Risk Information System (IRIS) database. In addition, 
today's rule proposes to correct mistakes in Appendix A of the CCR 
Rule. These minor changes to Appendix A address errors in the list of 
major sources in drinking water for copper, the placement of regulatory 
and health effects information for the disinfection byproducts (i.e., 
bromate, chloramines, chlorite, chlorine, and chlorine dioxide), and 
reference to chloride dioxide instead of chlorine dioxide. EPA is not 
reopening its consideration of the health effects statements in the PN 
and CCR Rules for contaminants other than DEHA and DEHP.

DATES: Written comments on this proposed rule must be received by 
October 9, 2001.

ADDRESSES: Send written comments to the Comment Clerk, docket number W-
01-07, Water Docket (MC 4101), Rm EB 57, U.S. Environmental Protection 
Agency, 1200 Pennsylvania Ave, NW Washington, DC 20460. The record for 
this proposed rule is established under docket number W-01-07. The 
record is available for inspection from 9 a.m. to 4 p.m. Monday through 
Friday, excluding legal holidays at the Water Docket, East Tower 
Basement, Rm EB 57, USEPA, 401 M Street, SW, Washington DC. For access 
to docket materials, please call 202-260-3027 to schedule an 
appointment. Comments may be hand-delivered to the Water Docket, U.S. 
Environmental Protection Agency; 401 M Street SW, East Tower Basement, 
Rm EB 57, Washington DC, 20460.

FOR FURTHER INFORMATION CONTACT: Kathleen Williams at (202)-260-2589 or 
e-mail: [email protected]. Contact the Safe Drinking Water 
Hotline (800-425-4791) for general information about these rules. Hours 
of operation are 9 am to 5:30 pm (ET), Monday -Friday, excluding 
Federal holidays.

SUPPLEMENTARY INFORMATION:

                       Table of Regulated Entities
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           Category                  Examples of regulated entities
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State/Local/Tribal             Publicly-owned PWSs, such as
 governments.                   municipalities; county governments,
                                water districts, water and sewer
                                authorities, state governments, and
                                other publicly- owned entities that
                                deliver drinking water as an adjunct to
                                their primary business (e.g., schools,
                                State parks, roadside rest stops).
Industry.....................  Privately-owned PWSs, such as private
                                utilities, homeowner associations, and
                                other privately-owned entities that
                                deliver drinking water as an adjunct to
                                their primary business (e.g., trailer
                                parks, factories, retirement homes, day-
                                care centers).
Federal government...........  Federally-owned PWSs, such as water
                                systems on military bases.
------------------------------------------------------------------------

      
    In June 2000, the American Chemistry Council (ACC) filed a petition 
for review of the May 4, 2000 revised Public Notification (PN) Rule in 
the D.C. Circuit Court of Appeals, alleging that EPA violated 
Administrative Procedure Act (APA) notice and comment requirements with 
respect to the health effects language for the contaminants di(2-
ethylhexyl)adipate (DEHA) and di(2-ethylhexyl)phthalate (DEHP). ACC 
contended that the Agency relied solely on the Integrated Risk 
Information System (IRIS) database to develop health effects language 
for these two contaminants although other information was available. As 
part of a settlement agreement with ACC, EPA is proposing minor 
modifications for the DEHA and DEHP health effects language used in the 
PN and Consumer Confidence Report (CCR) Rules. EPA is also including a 
statement in this preamble on the proper use of IRIS.
    EPA is also using today's action to propose other minor changes for 
Appendix A of the CCR Rule. In Appendix A ``leaching from wood 
preservatives'' is incorrectly listed as a major source of copper in 
drinking water. This rule deletes ``leaching from wood preservatives'' 
from the list of major sources for copper. Regulatory and health 
effects information for the disinfection byproducts bromate, 
chloramines, chlorite, chlorine, and chlorine dioxide is incorrectly 
placed in the volatile organic contaminants section of Appendix A. In 
addition, the entry for chlorine dioxide was inadvertently listed as 
chloride dioxide. Today's action moves entries for the disinfection 
byproducts from their existing locations and places them in the 
inorganic contaminants section of Appendix A. Misspelling of chlorine 
dioxide is also corrected.

I. Proposed Revisions to the Public Notification Rule

    Section 1414(c) of the SDWA required EPA to revise its existing 
regulations governing the public notification that public water systems 
must provide to the persons served by the system when the system 
violates drinking water standards, or in certain other circumstances. 
This public notification is an integral part of the public health 
protection and consumer right-to-know provisions of the SDWA as amended 
in 1996. EPA's regulations set the requirements that public water 
systems must follow regarding the form, manner, frequency, and content 
of a public notice. When there is a violation, public water systems 
must, among other things, provide information to the public on the 
potential health effects of exposure to the contaminant in question. 
The Public Notification (PN) Rule (40 CFR part 141, subpart Q) provides 
specific health effects statements for each regulated contaminant that 
a public water system must provide in its public notice.
    On May 14, 1999, EPA published proposed revisions to the PN rule 
for public comment. In that rulemaking EPA proposed to use the same 
brief health effects language for the PN Rule as EPA had recently 
required for the CCR Rule, issued in August, 1998. As a result, the PN 
proposal contained the CCR health effects language for DEHP

[[Page 46929]]

and DEHA. During the public comment period, the Chemical Manufacturers 
Association (now known as the American Chemistry Council) submitted 
comments questioning several aspects of the health effects language for 
these two contaminants, including the reference to ``general toxic 
effects'' for DEHA and the basis for characterizing DEHP as a human 
carcinogen. They submitted over 100 pages of comments on these 
contaminants providing support for their suggested changes to the 
health effects language. EPA did not change the health effects 
statements as a result of these comments, but responded to the comments 
by stating that the current health effects language for DEHA and DEHP 
is consistent with the most recent Agency IRIS document for those 
contaminants. EPA published the final public notification rule on May 
4, 2000.
    On June 30, 2000, the American Chemistry Council filed a petition 
for review of the final public notification rule in the D.C. Circuit 
Court of Appeals challenging the health effects language for these two 
contaminants. ACC specifically challenged EPA's failure to respond to 
their extensive comments on the health effects language and EPA's 
apparent reliance solely on the IRIS database.
    To resolve the ACC petition, EPA reconsidered comments requesting 
changes to health effects language and agreed that the response to 
comments with respect to the issues ACC raised was inadequate. However, 
any contention that EPA relies solely on IRIS data for health effects 
language is inaccurate. EPA does not rely solely on IRIS in developing, 
or considering changes to, the health effects statements for the CCR 
and PN Rules.
    EPA recognizes that IRIS is not a comprehensive toxicological 
database. There may be more recent relevant information available than 
is contained in IRIS. IRIS values are not rules adopted after notice 
and comment rulemaking, although recent IRIS assessments are posted on 
the Internet and public comments are solicited. IRIS values are not 
legally binding and are not entitled to conclusive weight in any 
rulemaking. In addition, EPA or any State agency that uses IRIS should 
not rely exclusively on IRIS values but should consider all credible 
and relevant information that is submitted in any particular 
rulemaking. If an outside party questions IRIS values during the course 
of an EPA rulemaking (such as a rule to establish health effects 
language for a contaminant for CCR and PN purposes), EPA considers all 
credible and relevant information before it in that proceeding.
    EPA also believes that some minor changes to the health effects 
language for these two contaminants is appropriate based on the 
existing science (which, as noted above, includes but is not limited to 
the IRIS database.) The specific changes and the rationale for those 
changes is discussed in detail below.

A. Di(2-ethylhexyl)phthalate

    Di(2-ethylhexyl)phthalate (DEHP) was regulated by EPA in 1992 as a 
B2 Carcinogen (probable human carcinogen) with an MCLG of zero and an 
MCL of 0.006 mg/L (57 FR 31776). The regulation was based on a 1987 EPA 
assessment of the data from a study in rats by the National Toxicology 
Program (NTP, 1982). Noncancer effects of concern included 
proliferation of peroxisomes, and enlargement of the liver, factors 
that appear to play a role in tumor development, and effects on 
reproduction and development (U.S. EPA, 1991). The Consumer Confidence 
Report/Public Notification language was developed to reflect the 
potential for these effects to occur when the drinking water exposure 
exceeds the MCL for a long period of time. The health effects language 
for DEHP given in Appendix A of the CCR Rule (40 CFR part 141, subpart 
O) and Appendix B of the PN Rule ( 40 CFR part 141, subpart Q) states:

    ``Some people who drink water containing di(2-
ethylhexyl)phthalate in excess of the MCL over many years may have 
problems with their liver, or experience reproductive difficulties, 
and may have an increased risk of getting cancer.''

    ACC objected to three components of the Consumer Confidence Report/
Public Notification language as follows:
--ACC felt that EPA should not rely on the 1987 cancer classification 
for DEHP;
--ACC felt that it was very unlikely that DEHP was a cancer hazard in 
humans and that this should be reflected in the Consumer Confidence 
Report/Public Notification language; and
--ACC requested that EPA delete the reference to reproductive effects.
    In the opinion of EPA, the requested modifications to the Consumer 
Confidence Report/ Public Notification language are not consistent with 
the DEHP toxicological data. DEHP does not appear to be a genotoxic 
carcinogen, but it has not been possible to completely define its mode 
of tumorigenic action at this time. The data suggest that activation of 
the Peroxisome Proliferator Activated Receptor, the production of 
hydrogen peroxide by peroxisomes, enhanced cell proliferation, and 
apoptosis may all play a role in tumorigenesis (ATSDR, 2000). However, 
unless an assessment that incorporates and links the various lines of 
evidence for a nonlinear mode of action can be completed, 
carcinogenicity remains as an endpoint of human concern. An Agency 
assessment is presently underway which may change the classification 
and quantification of the cancer endpoint, but it is premature to 
predict the final conclusion of that assessment.
    In the time that has elapsed since EPA regulated DEHP, the link 
between DEHP and effects on reproduction and development has been 
strengthened (Hileman, 2000). Accordingly, there is no justification 
for removing the language about the potential for reproductive effects 
from the Consumer Confidence Report/Public Notification language. 
Reproductive effects that are associated with exposure to DEHP include 
abnormalities in testicular maturation in males (Arcadi et al., 1998, 
Dostal et al., 1988; Gray and Butterworth, 1980), teratogenic effects 
(Tyl et al., 1988), and effects on fertility (Lamb et al., 1987). The 
data from the studies by Tyl and Lamb suggest a steep dose-response 
curve.
    On the other hand there are data that indicate that, at least for 
the biomarkers of liver effects including precancerous changes (i.e. 
induction of peroxisomal enzymes; liver enlargement), DEHP has a more 
pronounced effect on rodents than on primates. Accordingly, EPA feels 
that it is appropriate to qualify the exposures that may lead to 
adverse health effects from ingestion of water containing DEHP by 
saying that concentrations would have to be well in excess of the MCL 
(0.006 mg/L) and occur for a long period of time to be of concern. The 
testicular effects of DEHP can occur with short duration exposures, 
particularly if they occur in early development (Arcadi et al., 1998, 
Dostal et al., 1988). However, they appear to be reversible if exposure 
ceases before puberty (Dostal et al., 1988) and, thus, generate concern 
primarily when exposures occur over many years. Accordingly, EPA 
proposes to modify the Consumer Confidence Report/Public Notification 
language to state:

    ``Some people who drink water containing di(2-
ethylhexyl)phthalate well in excess of the MCL over many years may 
have problems with their liver, or experience reproductive 
difficulties, and may have an increased risk of getting cancer.''

--Di(2-ethylhexyl)adipate
    Di(2-ethylhexyl)adipate (DEHA) was regulated by EPA in 1992 as a C

[[Page 46930]]

Carcinogen (possible human carcinogen) with a MCLG of 0.4 mg/L and an 
enforceable MCL of 0.4 mg/L (57 FR 31776). The existing health effects 
statement regarding di(2-ethylhexyl) adipate, found in Appendix A of 
the CCR Rule (40 CFR part 141, subpart O) and Appendix B of the PN Rule 
(40 CFR part 141, subpart Q), is as follows:

    ``Some people who drink water containing di(2-ethylhexyl)adipate 
well in excess of the MCL over many years could experience general 
toxic effects or reproductive difficulties.''

    ACC raised concerns, and EPA has agreed, that the term ``general 
toxic effects'' in the existing health effect statement for di(2-
ethylhexyl)adipate may be unnecessarily vague and alarming to the 
public. The specific toxic effects of DEHA seen in animal toxicological 
studies are reduction in body weight gain and increase in absolute and 
relative liver weights. Accordingly, EPA is today proposing to replace 
the reference to ``general toxic effects'' with new language that 
incorporates a more specific description of these ``general toxic 
effects,'' namely, weight loss and liver enlargement.
    In addition, EPA is proposing to add the qualifier ``possible'' to 
the reference to ``reproductive difficulties'' in the health effects 
statement for DEHA in the PN and CCR Rules. The MCLG and MCL values for 
DEHA are derived from the Reference Dose (RfD) of 0.6 mg/kg/day.\1\ 
This RfD is based on two studies in rats: a one-generation reproductive 
toxicity study which examined effects on fertility, reproductive 
outcome and gross and histological parameters in parents of both sexes; 
and a developmental study which assessed the effects of DEHA on 
gestating females and their developing fetuses (ICI, 1988 a and b). 
Both studies identified a no-observed-adverse-effect level (NOAEL) of 
170 mg/kg/day. The data base for the derivation of the RfD was 
considered somewhat deficient because of the lack of a multi-generation 
reproductive study and the lack of relevant data in species other than 
rats. Accordingly, an uncertainty factor (UF) of 300 was applied to the 
NOAEL to derive the RfD of 0.6 mg/kg/day. This UF consists of the 
standard 100 factor for interspecies extrapolation and intraspecies 
variability, and an additional factor of 3 for database deficiencies.
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    \1\ Using the RfD of 0.6 mg/kg/day and assuming 70 kg body 
weight, 2 liter/day drinking water consumption, a relative source 
contribution of 20%, and applying an additional management factor of 
10 for possible carcinogenicity of DEHA, the MCLG is 0.4 mg/liter. 
The MCL was also established at 0.4 mg/liter.
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    In deriving the RfD for DEHA, it was therefore implicitly 
recognized that the data base for reproductive and developmental 
effects was not entirely satisfactory. To reflect this uncertainty in 
the data base, EPA believes it is appropriate to include in the new 
health effects statement the wording ``possible'' before ``reproductive 
difficulties.''
    Today, EPA is proposing to modify the existing health effects 
statement regarding di(2-ethylhexyl)adipate in the PN and CCR Rules to 
state as follows:

    ``Some people who drink water containing di(2-ethylhexyl)adipate 
well in excess of the MCL over many years could experience toxic 
effects such as weight loss, liver enlargement or possible 
reproductive difficulties.''

    EPA believes that this change is appropriate. It is critical that 
standard health effects language for public notification conveys to the 
public clear descriptions, in easy-to-understand language, of the 
potential adverse health effects of a drinking water contaminant when 
such a contaminant is found at concentrations above the Federal 
standard.

II. Proposed Revisions to the Consumer Confidence Report Rule

    The Consumer Confidence Report (CCR) Rule (40 CFR part 141, subpart 
O) requires community water systems to issue an annual water quality 
report to their customers. The report provides a snapshot of local 
drinking water quality, including information on the source of the 
water, the contaminants found in the water, the potential health 
effects of any contaminants found above Federal health standards, the 
ways the water system protects its water supply, and how consumers can 
get involved in protection of source water. As part of that rule, CWSs 
must provide a statement concerning the health effects of contaminants 
when those contaminants are found at levels that violate the regulatory 
standard. Because the PN and CCR rules are closely related, EPA has 
required that systems use the same health effects language for CCR 
purposes as for PN purposes. For this reason, EPA is proposing to make 
the same changes to the CCR health effects language for DEHP and DEHA 
as is proposed today for the PN Rule.
    EPA is also proposing to make the following minor corrections to 
Appendix A of the CCR Rule (40 CFR part 141, subpart O):
    A. For the entry on Copper: ``Leaching from wood preservatives'' is 
listed as a major source of copper in drinking water. EPA mistakenly 
included that listing although leaching from wood preservatives is not 
a major source of copper in drinking water. This rule proposes to 
delete that part of the entry so the amended appendix lists only 
``corrosion of household plumbing systems; erosion of natural 
deposits'' as major sources for copper in drinking water.
    B. For the disinfection byproducts entries: Bromate, Chloramines, 
Chlorite, Chlorine, and Chlorine Dioxide. EPA mistakenly placed 
information for these contaminants in the volatile organic contaminants 
section of Appendix A instead of the inorganic contaminants section. 
This rule proposes to correct that mistake by placing information for 
these contaminants in the inorganic contaminants section of Appendix A. 
Also, the entry for chlorine dioxide was misspelled. This rule also 
proposes to correct that mistake by replacing ``chloride dioxide'' with 
``chlorine dioxide'' in the appendix.
    EPA does not solicit, and will not respond to, comments on the text 
of the health effects statements for these or any contaminants other 
than DEHA and DEHP.

III. Administrative Requirements

A. Executive Order 12866--Regulatory Planning and Review

    Under Executive Order 12866, (58 FR 51735, October 4, 1993) the 
Agency must determine whether the regulatory action is ``significant'' 
and therefore subject to Office of Management and Budget (OMB) review 
and the requirements of the Executive Order. The Order defines 
``significant regulatory action'' as one that is likely to result in a 
rule that may:
    (1) Have an annual effect on the economy of $100 million or more or 
adversely affect in a material way the economy, a sector of the 
economy, productivity, competition, jobs, the environment, public 
health or safety, or State, local, or tribal governments or 
communities;
    (2) create a serious inconsistency or otherwise interfere with an 
action taken or planned by another agency;
    (3) materially alter the budgetary impact of entitlements, grants, 
user fees, or loan programs or the rights and obligations of recipients 
thereof; or
    (4) raise novel legal or policy issues arising out of legal 
mandates, the President's priorities, or the principles set forth in 
the Executive Order.
    It has been determined that this rule is not a ``significant 
regulatory action'' under the terms of Executive Order 12866 and is 
therefore not subject to OMB review.

[[Page 46931]]

B. Executive Order 13045--Protection of Children From Environmental 
Health Risks and Safety Risks

    Executive Order 13045 (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 the Executive Order because it is not 
economically significant as defined in Executive Order 12866. This rule 
makes minor changes to the Public Notification Rule and Consumer 
Confidence Report Rule which do not change the regulatory burden.

C. Unfunded Mandates Reform Act

    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 the 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, local, and tribal 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 the UMRA generally requires EPA to identify 
and consider a reasonable number of regulatory alternatives and adopt 
the least costly, most cost-effective or least burdensome alternative 
that achieves the objectives of the rule. The provisions of section 205 
do not apply when they are inconsistent with applicable law. Moreover, 
section 205 allows EPA to adopt an alternative other than the least 
costly, most cost-effective or least burdensome alternative if the 
Administrator publishes with the final rule an explanation why that 
alternative was not adopted.
    Before EPA establishes any regulatory requirements that may 
significantly or uniquely affect small governments, including tribal 
governments, it must have developed under section 203 of the UMRA a 
small government agency plan. The plan must provide for notifying 
potentially affected small governments, enabling officials of affected 
small governments to have meaningful and timely input in the 
development of EPA regulatory proposals with significant Federal 
intergovernmental mandates, and informing, educating, and advising 
small governments on compliance with the regulatory requirements.
    Today's rule contains no Federal mandates (under the regulatory 
provisions of Title II of the UMRA) for State, local, or Tribal 
governments or the private sector. The rule imposes no enforceable duty 
on any State, local or Tribal governments or the private sector. This 
rule does not change the costs to State, local, or Tribal governments 
as estimated in the final Public Notification Rule (65 FR 26020, May 4, 
2000) and the final Consumer Confidence Report Rule (August 19, 1998, 
63 FR 44511), and does not change either the frequency of reports or 
the regulatory burden of public notification. Thus, today's rule is not 
subject to the requirements of sections 202 and 205 of the UMRA.
    For the same reason, EPA has determined that this proposed rule 
contains no regulatory requirements that might significantly or 
uniquely affect small governments. Thus today's rule is not suject to 
the requirements of section 203 of UMRA.

D. Paperwork Reduction Act

    This action does not impose any new information collection burden 
under the provisions of the Paperwork Reduction Act, 44 U.S.C. 3501 et 
seq. This rule makes minor changes to the Public Notification Rule and 
the Consumer Confidence Report Rule, and does not change the frequency 
of reporting or the regulatory burden. The rule imposes no additional 
enforceable duty on any State, local or tribal governments or the 
private sector.
    Burden means the total time, effort, or financial resources 
expended by persons to generate, maintain, retain, or disclose or 
provide information to or for a Federal agency. This includes the time 
needed to review instructions; develop, acquire, install, and utilize 
technology and systems for the purposes of collecting, validating, and 
verifying information, processing and maintaining information, and 
disclosing and providing information; adjust the existing ways to 
comply with any previously applicable instructions and requirements; 
train personnel to be able to respond to a collection of information; 
search data sources; complete and review the collection of information; 
and transmit or otherwise disclose the information.
    An Agency may not conduct or sponsor, and a person is not required 
to respond to a collection of information, unless it displays a 
currently valid OMB control number. The OMB control numbers for EPA's 
regulations are listed in 40 CFR part 9 and 48 CFR chapter 15.

E. Regulatory Flexibility Act (RFA), as amended by the Small Business 
Regulatory Enforcement Fairness Act of 1996 (SBREFA), 5 U.S.C. 601 
et.seq.

    The RFA generally requires an agency to prepare a regulatory 
flexibility analysis of any rule subject to the notice-and-comment 
rulemaking requirement 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 
government 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 for 
the agency'' after proposing the alternative definition(s) in the 
Federal Register and taking comment. 5 U.S.C. 601(30-(5). In addition 
to the above, to establish an alternative small business definition, 
agencies must consult with SBA's Chief Counsel for Advocacy.
    For purposes of assessing the impacts of today's rule on small 
entities, EPA considered small entities to be public water systems 
serving 10,000 or fewer persons. This is the cut-off level specified by 
Congress in the Safe Drinking Water Act Amendments of 1996 for small 
system flexibility provisions. In accordance with the RFA requirements, 
EPA proposed using this alternative definition in the Federal Register 
(63 FR 7620, February 13, 1998), requested public comment, consulted 
with the Small Business Administration, finalized this definition for 
the final CCR regulation, and expressed its intention to use the 
alternative definition for all future drinking water regulations (63 FR 
44511, August 19, 1998).
    After considering the economic impacts of today's proposed rule on 
small entities, I certify that this action will not have a significant 
economic impact on a substantial number of small entities. This rule 
makes minor changes to the Public Notification Rule and the Consumer 
Confidence Report Rule and imposes no additional enforceable duty on 
any State, local or tribal governments or the private sector. It does 
not change

[[Page 46932]]

either the frequency of reports or the regulatory burden of public 
notification.
    We continue to be interested in the potential impacts of the 
proposed rule on small entities and welcome comments on issues related 
to such impacts.

F. National Technology Transfer and Advancement Act

    Section 12 (d) of the National Technology Transfer and Advancement 
Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 
note), directs EPA to use voluntary consensus standards in its 
regulatory activities unless to do so would be inconsistent with 
applicable law or otherwise impractical. Voluntary consensus standards 
are technical standards (e.g., material specifications, test methods, 
sampling procedures, and business practices) that are developed or 
adopted by voluntary consensus standards bodies. The NTTAA directs EPA 
to provide Congress, through OMB, explanations when the Agency decides 
not to use available and applicable voluntary consensus standards.
    This proposed rulemaking does not involve technical standards. 
Therefore, EPA is not considering the use of any voluntary consensus 
standards.
    EPA welcomes comments on this aspect of the proposed rulemaking 
and, specifically, invites the public to identify potentially-
applicable voluntary consensus standards and to explain why such 
standards should be used in this regulation.

G. Executive Order 12898--Environmental Justice Strategy

    Executive Order 12898 establishes a Federal policy for 
incorporating environmental justice into Federal agency missions by 
directing agencies to identify and address disproportionately high and 
adverse human health or environmental effects of its programs, 
policies, and activities on minority and low-income populations. 
Today's proposed rule makes minor changes to the Consumer Confidence 
Report Regulation and Public Notification Regulation, and does not 
alter the regulatory requirements of those regulations. The Agency 
considered environmental justice related issues concerning the 
potential impacts of public notification during development of the 
Public Notification Regulation and Consumer Confidence Report 
Regulation. In the May 4, 2000, PN Rule (65 FR 2620), EPA concluded 
that the PN requirements would be beneficial to low-income and minority 
communities. In the August 19, 1998 Consumer Confidence Report 
Regulation (August 19, 1998, 63 FR 44511), EPA determined that 
provisions in that regulation would be beneficial to low-income and 
minority communities, particularly the provision requiring a good faith 
effort to reach non bill-paying customers.

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.''
    This proposed rule does not have federalism implications. It will 
not have substantial direct effects on the States, on the relationship 
between the national government and the States, or on the distribution 
of power and responsibilities among the various levels of government, 
as specified in Executive Order 13132. Today's rule proposes minor 
changes to the Consumer Confidence Report Regulation and Public 
Notification Rule. Thus, Executive Order 13132 does not apply to this 
rule.
    In the spirit of Executive Order 13132, and consistent with EPA 
policy to promote communications between EPA and State and local 
governments, EPA specifically solicits comment on this proposed rule 
from State and local officials.

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 Indian tribes.''
    This proposed rule does not have tribal implications. It will not 
have substantial direct effects on tribal governments, on the 
relationship between the Federal government and Indian tribes, or on 
the distribution of power and responsibilities between the Federal 
government and Indian tribes, as specified in Executive Order 13175. 
Today's rule makes minor changes to the Consumer Confidence Report Rule 
and Public Notification Rule. It imposes no additional enforceable duty 
on any tribal governments or the private sector, and does not change 
either the frequency of reports or the regulatory burden of public 
notification. Thus, Executive Order 13175 does not apply to this rule.
    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.

J. 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: (1)(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.'' This rule is not 
subject to Executive Order 13211, because it is not a significant 
regulatory action under Executive Order 12866.

IV. References

    Agency for Toxic Substances and Disease Registry (ATSDR) 1999. 
Toxicological profile for di(2-ethylhexyl)phthalate. December. U.S.

[[Page 46933]]

Department of Health and Human Services. Public Health Service.
    Agency for Toxic Substances and Disease Registry (ATSDR) 2000. 
Toxicological profile for di(2-ethylhexyl)phthalate (update) September 
U.S. Department of Health and Human Services. Public Health Service.
    Arcadi, F.A., C. Costa, C. Imperatore, A. Marchese, A. Rapisarda, 
M. Salemi, G.R. Trimarchi, and G. Costa, 1998. Oral toxicity of bis(2-
ethylhexyl)phthalate during pregnancy and suckling in Long-Evans rat. 
Food Chem Toxicol 36:963-970 (as cited in ATSDR, 2000).
    Dostal, L.A., R.E. Chapin, S.A. Stephanski, M.W. Harris, and B.A. 
Schwetz, 1988. Testicular toxicity and reduced Sertoli cell numbers in 
neonatal rats by di(2-ethylhexyl)phthalate and the recovery of 
fertility as adults. Toxicol. Appl. Pharmacol. 95:104-121.
    Gray, T.J. and K.R. Butterworth. 1980. Testicular atrophy produced 
by phthalate esters. Arch. Toxicol. 1980 (Supp. 4):452-455.
    Hileman, B. 2000. Alert on phthalates. Chem, and Eng. News. 78 
(32):52-54.
    ICI Central Toxicology Laboratory (1988a). ``Di(2-
ethylhexyl)adipate (DEHA): Fertility study in rats.'' Study No. RR0374. 
Alderly Park, Cheshire, UK. Tinston DJ.
    ICI Central Toxicology Laboratory (1988b). ``Di(2-
ethylhexyl)adipate: Teratogenicity study in the rat''. Study No. 
RR0372. Alderly Park, Cheshire, UK. Hodge MCE.
    Lamb, J.C., R.E. Chapin, J. Teague, A.D Lawton, J.R. Reel, 1987. 
Reproductive effects of four phthalic acid esters in the mouse. 
Toxicol. Appl. Pharmacol. 88:255-269.
    NTP 1982. Carcinogenesis bioassay of di(2-ethylhexyl)phthalate (CAS 
No 117-81-7) in F344 rats and B6C3F1 mice. Department of 
Health and Human Services. Public Health Services. National Institute 
of Health. NTP Publication No. 217.
    Tyl, R.W. 1988. Developmental toxicity evaluation of dietary di(2-
ethylhexyl) phthalate in Fischer 344-rats and CD-1 mice. 10:395-412.
    U.S. EPA. 1991. Drinking Water Criteria Document for Phthalic Acid 
Esters (PAES). Environmental Criteria and Assessment Office. Office of 
Health and Environmental Assessment. Cincinnati, OH 45268. ECAO-CIN-
D009. August 1988, Revised August 1991.

List of Subjects in 40 CFR Part 141

    Environmental protection, Chemicals, Intergovernmental relations, 
Reporting and recordkeeping requirements, Water supply.

    Dated: August 30, 2001.
Christine Todd Whitman,
Administrator.
    For the reasons set out in the preamble, 40 CFR part 141 is 
proposed to be amended as follows:

PART 141--[AMENDED]

    1. The authority citation for part 141 continues to read as 
follows:

    Authority: 42 U.S.C 300f, 300g-1, 300g-2, 300g-3, 300g-4, 300g-
5, 300g-6, 300j-4, 300j-9, and 300j-11.

Subpart Q--[AMENDED]

    2. Appendix B to Subpart Q is amended by revising entries 33. for 
``Di(2-ethylhexyl) adipate'' and 34. for ``Di(2-ethylhexyl) phthalate'' 
to read as follows:

          Appendix B to Subpart Q of Part 141--Standard Health Effects Language for Public Notification
----------------------------------------------------------------------------------------------------------------
                                                                     Standard health effects language for public
           Contaminant (units)             MCLG (mg/l)   MCL (mg/l)                  notification
----------------------------------------------------------------------------------------------------------------
 
*                  *                  *                  *                  *                  *
                                                        *
E. Synthetic Organic Chemicals (SOCs)....
 
*                  *                  *                  *                  *                  *
                                                        *
33. Di(2-ethylhexyl) adipate.............          0.4          0.4  Some people who drink water containing di(2-
                                                                      ethylhexyl)adipate well in excess of the
                                                                      MCL over many years could experience toxic
                                                                      effects such as weight loss, liver
                                                                      enlargement or possible reproductive
                                                                      difficulties.
34. Di(2-ethylhexyl) phthalate...........            0        0.006  Some people who drink water containing di(2-
                                                                      ethylhexyl)adipate well in excess of the
                                                                      MCL over many years may have problems with
                                                                      their liver, or experience reproductive
                                                                      difficulties, and may have an increased
                                                                      risk of getting cancer.
 
*                  *                  *                  *                  *                  *
                                                        *
----------------------------------------------------------------------------------------------------------------

Subpart O--[AMENDED]

    3. Appendix A to Subpart O is amended:
    a. under the heading ``Volatile organic contaminants'' by removing 
entries for: ``Bromate (ppb), ``Chloramines (ppm)'', ``Chlorite 
(ppm)'', ``Chlorine (ppm)'', and ``Chloride dioxide (ppm)''.
    b. under the heading ``Inorganic contaminants'' by adding in 
alphabetical order entries for: ``Bromate (ppb), ``Chloramines (ppm)'', 
``Chlorine (ppm)'', ``Chlorine dioxide (ppm)'', and ``Chlorite (ppm)''.
    c. under the heading ``Inorganic contaminants'' by revising the 
entry for ``copper (ppm)''.
    d. under the heading ``Synthetic organic contaminants including 
pesticides and herbicides'' by revising entries for ``Di(2-ethylhexyl) 
adipate (ppb)'' and ``Di(2-ethylhexyl) phthalate (ppb)''.

[[Page 46934]]



                                                     Appendix A to Subpart O--Regulated Contaminants
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                         To convert
           Contaminant (units)             Traditional    for CCR,    MCL in CCR      MCLG      Major sources in drinking      Health effects language
                                           MCL in mg/L  multiply by     units                             water
--------------------------------------------------------------------------------------------------------------------------------------------------------
 
                   *                  *                  *                  *                  *                  *                  *
Inorganic contaminants:
 
                   *                  *                  *                  *                  *                  *                  *
Bromate (ppb)............................        0.010         1000           10            0  By-product of drinking       Some people who drink water
                                                                                                water chlorination.          containing bromate in
                                                                                                                             excess of the MCL over many
                                                                                                                             years may have an increased
                                                                                                                             risk of getting cancer.
 
                   *                  *                  *                  *                  *                  *                  *
Chloramines (ppm)........................     MRDL = 4                  MRDL = 4    MRDLG = 4  Water additive used to       Some people who use water
                                                                                                control microbes.            containing chloramines well
                                                                                                                             in excess of the MRDL could
                                                                                                                             experience irritating
                                                                                                                             effects to their eyes and
                                                                                                                             nose. Some people who drink
                                                                                                                             water containing
                                                                                                                             chloramines well in excess
                                                                                                                             of the MRDL could
                                                                                                                             experience stomach
                                                                                                                             discomfort or anemia.
Chlorine (ppm)...........................     MRDL = 4                  MRDL = 4     MRDL = 4  Water additive used to       Some people who use water
                                                                                                control microbes.            containing chlorine well in
                                                                                                                             excess of the MRDL could
                                                                                                                             experience irritating
                                                                                                                             effects to their eyes and
                                                                                                                             nose. Some people who drink
                                                                                                                             water containing chlorine
                                                                                                                             well in excess of the MRDL
                                                                                                                             could experience stomach
                                                                                                                             discomfort.
Chlorine dioxide (ppm)...................    MRDL = .8         1000   MRDL = 800  MRDLG = 800  Water additive used to       Some infants and young
                                                                                                control microbes.            children who drink water
                                                                                                                             containing chlorine dioxide
                                                                                                                             in excess of the MRDL could
                                                                                                                             experience nervous system
                                                                                                                             effects. Similar effects
                                                                                                                             may occur in fetuses of
                                                                                                                             pregnant women who drink
                                                                                                                             water containing chlorine
                                                                                                                             dioxide in excess of the
                                                                                                                             MRDL. Some people may
                                                                                                                             experience anemia.
Chlorite (ppm)...........................            1                         1          0.8  By-product of drinking       Some infants and young
                                                                                                water chlorination.          children who drink water
                                                                                                                             containing chlorite in
                                                                                                                             excess of the MCL could
                                                                                                                             experience nervous system
                                                                                                                             effects. Similar effects
                                                                                                                             may occur in fetuses of
                                                                                                                             pregnant women who drink
                                                                                                                             water containing chlorite
                                                                                                                             in excess of the MCL. Some
                                                                                                                             people may experience
                                                                                                                             anemia.
 
                   *                  *                  *                  *                  *                  *                  *
Copper (ppm).............................       AL=1.3                    AL=1.3          1.3  Corrosion of household       Copper is an essential
                                                                                                plumbing systems; Erosion    nutrient, but some people
                                                                                                of natural deposits.         who drink water containing
                                                                                                                             copper in excess of the
                                                                                                                             action level over a
                                                                                                                             relatively short amount of
                                                                                                                             time could experience
                                                                                                                             gastrointestinal distress.
                                                                                                                             Some people who drink water
                                                                                                                             containing copper in excess
                                                                                                                             of the action level over
                                                                                                                             many years could suffer
                                                                                                                             liver or kidney damage.
                                                                                                                             People with Wilson's
                                                                                                                             disease should consult
                                                                                                                             their personal doctor.
 
                   *                  *                  *                  *                  *                  *                  *
Synthetic organic contaminants including
 pesticides and herbicides:

[[Page 46935]]

 
Di(2-ethylhexyl) adipate (ppb)...........           .4         1000          400          400  Discharge from chemical      Some people who drink water
                                                                                                factories.                   containing di(2-ethylhexyl)
                                                                                                                             adipate well in excess of
                                                                                                                             the MCL over many years
                                                                                                                             could experience toxic
                                                                                                                             effects such as weight
                                                                                                                             loss, liver enlargement or
                                                                                                                             possible reproductive
                                                                                                                             difficulties.
Di(2-ethylhexyl) phthalate (ppb).........         .006         1000            6            0  Discharge from rubber and    Some people who drink water
                                                                                                chemical factories.          containing di(2-ethylhexyl)
                                                                                                                             phthalate well in excess of
                                                                                                                             the MCL over many years may
                                                                                                                             have problems with their
                                                                                                                             liver, or experience
                                                                                                                             reproductive difficulties,
                                                                                                                             and may have an increased
                                                                                                                             risk of getting cancer.
 
                   *                  *                  *                  *                  *                  *                  *
--------------------------------------------------------------------------------------------------------------------------------------------------------

[FR Doc. 01-22522 Filed 9-6-01; 8:45 am]
BILLING CODE 6560-50-P