[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.
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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