[Federal Register Volume 63, Number 40 (Monday, March 2, 1998)]
[Rules and Regulations]
[Pages 10140-10144]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-5091]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 131
[FRL-5971-9]
Withdrawal From Federal Regulations of the Applicability to
Alaska's Waters of Arsenic Human Health Criteria
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: In 1992, EPA promulgated federal regulations establishing
water quality criteria for toxic pollutants for several states,
including Alaska (40 CFR 131.36). One of the toxic pollutants included
in that rule was arsenic. In this final rule, EPA withdraws the
applicability to Alaska's waters of the federal human health criteria
for arsenic.
DATES: This rule is effective on April 1, 1998.
ADDRESSES: The administrative record for this rule is available for
public inspection at EPA Region 10, Office of Water, 1200 Sixth Avenue,
Seattle, Washington, 98101, between 8:00 a.m. and 4:30 p.m. Copies of
the record are also available for public inspection at EPA's Alaska
Operations Offices: 222 West 7th Avenue, Anchorage, AK and 410
Willoughby Avenue, Juneau, AK.
FOR FURTHER INFORMATION CONTACT: Fred Leutner at EPA Headquarters,
Office of Water (4305), 401 M Street SW, Washington, DC 20460
(telephone: 202-260-1542), or Sally Brough in EPA's Region 10
(telephone: 206-553-1295).
SUPPLEMENTARY INFORMATION:
Potentially Affected Entities
Citizens concerned with water quality in Alaska, and with pollution
from arsenic in particular, may be interested in this rulemaking. Since
criteria are used in determining NPDES permit limits, entities
discharging arsenic to waters of the United States in Alaska could be
affected by this rulemaking. Potentially affected entities include:
[[Page 10141]]
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Category Examples of affected entities
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Industry............................... Industries discharging arsenic
to surface waters in Alaska.
Municipalities......................... Publicly-owned treatment works
discharging arsenic to surface
waters in Alaska.
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This table is not intended to be exhaustive, but rather provides a
guide for readers regarding entities likely to be affected by this
action. This table lists the types of entities that EPA is now aware
could potentially be affected by this action. Other types of entities
not listed in the table could also be affected. To determine whether
your facility could be affected by this action, you should carefully
examine the applicability criteria in section 131.36 of title 40 of the
Code of Federal Regulations. If you have any questions regarding the
applicability of this action to a particular entity, consult the person
listed in the preceding FOR FURTHER INFORMATION CONTACT section.
Background
On December 22, 1992, the Environmental Protection Agency (EPA or
Agency) promulgated a rule to establish federal water quality criteria
for priority toxic pollutants applicable in 14 states. That rule, which
is commonly called the National Toxics Rule (NTR), is codified at 40
CFR 131.36. The specific requirements for Alaska are codified at
section 131.36(d)(12) and among other criteria, include water quality
criteria for the protection of human health from arsenic. EPA
promulgated a human health criterion for Alaska of 0.18 g/L to
protect waters designated for the consumption of water (i.e., sources
of drinking water) and the consumption of aquatic life which includes
fish and shellfish such as shrimp, clams, oysters and mussels. This
criterion is located in column D1 in the criteria matrix at section
131.36(b)(1). EPA also promulgated a human health criterion of 1.4
g/L for waters designated for the consumption of aquatic life
without considering water consumption. This criterion is located in
column D2 in the criteria matrix. These concentrations are designed to
not exceed an excess lifetime cancer risk of 1 in 100,000 (or
10-5) and reflected Alaska's preference for risk levels as
expressed in its own rule adoptions and in correspondence with EPA's
Region 10. See 57 FR 60848 and 57 FR 60867.
Subsequent to the promulgation of the NTR, a number of issues and
uncertainties arose concerning the health effects of arsenic. EPA
determined that these issues and uncertainties were sufficiently
significant to necessitate a careful evaluation of the risks of arsenic
exposure. Accordingly, EPA has undertaken a number of activities aimed
at reassessing the risks to human health from arsenic. (See Basis and
Purpose section below.)
In light of EPA's review of the health effects of arsenic, the
State of Alaska requested EPA to allow the state to use an arsenic
criteria of 50 g/L which is based on the maximum contaminant
level (MCL) promulgated by EPA pursuant to the Safe Drinking Water Act,
and is currently in the state's water quality standards in lieu of the
human health criteria in the NTR. As adopted by Alaska, the 50
g/l for arsenic applies to almost all fresh waters that have
the public water supply designated use. (According to the state, this
includes all but 10 fresh-water segments.)
Proposed Rule
On May 21, 1997, EPA proposed to withdraw from the NTR the
applicability to Alaska of the arsenic human health criteria, and
requested public comments by July 7, 1997 (62 FR 27707). As discussed
in the preamble to the proposed rule, EPA made a preliminary
determination that the 50 g/l value for arsenic in freshwater
designated for public water supply, in conjunction with Alaska's
aquatic life criteria for arsenic, meets the requirements of the CWA,
and solicited public comment on that determination. Following requests
to allow more time to review the supporting record, EPA re-opened the
public comment period on July 18, 1997 for 2 additional weeks, with
final closing on August 4, 1997 (62 FR 38512). EPA received 70 comment
letters comprising 320 pages.
Final Rule
As discussed below under Basis and Purpose and Response to
Comments, EPA in this rulemaking is finalizing the proposed withdrawal
of the applicability to Alaska's waters of EPA's human health criteria
for arsenic. In a totally unrelated action, EPA recently removed the
NTR aquatic life criteria for 19 acute aquatic life criteria applicable
to Alaska (62 FR 53212, October 10, 1997). Arsenic was one of the
criteria included in that federal action. As a result, when this
rulemaking becomes effective, Alaska's current adopted criteria
approved by EPA will be the only applicable water quality criteria for
arsenic in Alaska. These criteria are: A chronic marine aquatic life
criterion of 36 g/L, a chronic freshwater aquatic life
criterion of 190 g/L, and the freshwater criterion of 50
g/L for waters designated for public water supply discussed
above. The aquatic life criteria are in place for all of the state's
marine and estuarine waters, and in all fresh waters, including those
few cases where the 50 g/l value is not applicable.
Basis and Purpose for Final Rule
EPA has recognized the use of appropriate MCLs in establishing
water quality standards under the CWA. Agency guidance notes the
differences between the statutory factors for developing SDWA MCLs and
CWA section 304(a) criteria, but provides that where human consumption
of drinking water is the principal exposure to a toxic chemical, then
an existing MCL may be an appropriate concentration limit. See guidance
noticed in 54 FR 346, January 5, 1989. Similarly, the CWA section
304(a) human health guidelines are consistent with this position. See
45 FR 79318, November 28, 1980.
To determine whether the MCL could appropriately be used in lieu of
the NTR's human health criteria for arsenic, EPA prepared an exposure
analysis. This analysis estimates the significance of human consumption
of fish and shellfish containing the amounts of inorganic arsenic
indicated as present in representative samples of fish and shellfish,
in conjunction with the consumption of water containing concentrations
of arsenic currently existing in the Nation's waters. See EPA's
``Arsenic and Fish Consumption'' (EPA-822-R-97-003, December 3, 1997)
in the administrative record for this rulemaking. This analysis first
recognizes that the most toxic form of arsenic is inorganic arsenic.
Inorganic arsenic is the principal form in surface waters and almost
the exclusive form in ground waters. However, because of the metabolic
processes affecting arsenic in the food chain, the arsenic in fish and
most shellfish is largely present as organic arsenic (mostly
arsenobetaine), which is significantly less toxic than the inorganic
form. Available information indicates that arsenobetaine passes through
these organisms with minimal retention in the fish, shellfish and human
tissues.
In the NTR, EPA based the promulgated criteria on the human health
criteria methodology contained in the 1980 human health guidelines. See
45 FR 79318, November 28, 1980. To estimate the ambient water
concentration of a pollutant that does not represent a significant risk
to the public (i.e., the criteria levels), the
[[Page 10142]]
methodology makes certain assumptions about human exposure to
pollutants. The methodology assumes that for most people, drinking
water intake is 2 liters per day, and that fish consumption is 6.5
grams per day (a little less than one-half pound per month). The
methodology incorporates a bioconcentration factor (BCF) to account for
a pollutant's concentration in fish and shellfish tissue versus its
concentration in the water. The methodology also assumes that all of
the water and fish consumed is contaminated at the criteria levels (the
``safe'' levels).
Using these same exposure factors from the methodology, EPA has
assessed the protectiveness of the 50 g/l arsenic value as a
human health water quality criterion. In its analysis, EPA focused on
the inorganic form of arsenic, because of its far greater toxicity than
the organic forms. Assuming that the concentration of arsenic in water
is at 50 g/L, primarily in the inorganic form, most people
would be exposed to up to 100 g of inorganic arsenic from
their drinking water intake (i.e., 2 L/day x 50 g/L = 100
g/day), and 0.6 g/day of inorganic arsenic from
consuming 6.5 grams of fish and shellfish collected from water at the
50 g/l arsenic concentration and assuming the BCF used in the
NTR. (See derivation in EPA's ``Arsenic and Fish Consumption'' in the
record.) The total estimated exposure would be 100.6 g/day
which could consist entirely of inorganic arsenic. EPA considers the
small increment of exposure from fish consumption to be insignificant.
EPA therefore concludes that when applied to fresh waters in Alaska,
use of 50 g/L as an ambient water quality criterion for
arsenic (assuming both water and fish consumption) generally provides a
level of protection equivalent to that provided by water consumption
only at 50 g/l. A full characterization of other exposure
scenarios is contained in EPA's exposure analysis described above. This
analysis is in the administrative record for this rule and has
undergone external peer review. The results of the peer review were
considered by the Agency in preparing today's final action. The peer
review comments and EPA's response to those comments are included in
the administrative record for this proceeding. In general, EPA
considers the peer review to be supportive of the methodology applied
to support today's action.
There may be regions in Alaska where high levels of arsenic in the
potable water are accompanied by high levels of fish and shellfish
consumption that also may be high in arsenic contamination. In some of
these situations, it is possible that a water quality criterion of 50
g/l would not provide an acceptable level of protection, and
additional action would be needed. In a recent letter, the State of
Alaska stated,
``AS 46.03.110(d) [Alaska Statutes] and 18 AAC 70.025 [Alaska
Administrative Code] authorizes us to use site-specific data to
develop appropriate permit limits or site specific criteria to
further our statutory mission, which includes protection of public
health. It is our practice, and will continue to be our practice, to
evaluate specific water quality concerns raised by an affected
community or individual. If there is indication of a potential
problem, we will use site specific data to set limits that fully
protect human health.'' [bracketed material added]. October 8, 1997
letter from Michelle Brown, Commissioner, Alaska Department of
Environmental Conservation, to Robert Perciasepe, Assistant
Administrator for EPA's Office of Water, which is in the
administrative record for this action.
EPA is pleased that the State of Alaska is prepared to act in such
situations, and stands ready to assist the state if necessary to
implement this policy. In developing site-specific criteria the state
should use its authorities to characterize the size and location of the
population of concern and determine their fish/shellfish and water
intake rates. The fish and shellfish consumption should consider the
species and dietary intake on a per species basis. Actual total arsenic
and inorganic arsenic values for the species consumed and actual
concentrations in drinking water should be used in the exposure
calculations whenever possible.
There are also a number of ongoing national activities that may
affect and/or necessitate a future change in the arsenic criteria for
both ambient and drinking water in Alaska. The National Academy of
Sciences (NAS) has initiated a study of the health risks posed by
arsenic in water. Results of the study are expected in the Spring of
1998. Moreover, EPA is in the process of reevaluating the risk
assessments for arsenic as part of a pilot program for reconfiguring
the Agency's Integrated Risk Information System (IRIS). EPA originally
planned this re-evaluation to cover aspects of both cancer and non-
cancer risks and to include examination of data not previously
reviewed. With the initiation of the NAS study, EPA redirected the
focus of the IRIS reevaluation to the application of the proposed
revisions to EPA's Guidelines for Cancer Risk Assessment. This
reevaluation of arsenic for IRIS has not yet been completed. EPA
encourages the state to review its water quality criteria for arsenic
as this new information becomes available.
Response to Comments on the Proposed Rule
The Agency received a number of public comments on the proposed
rule. The Agency has prepared a document entitled ``Response to Public
Comment'' which it is placing in the administrative record to this
action. EPA has considered all comments received in developing this
final rule. The majority of commenters favored EPA's proposed action.
However, several commenters urged EPA not to change its criteria in
Alaska. Their arguments focused on the various scientific factors
involved in supporting the NTR criterion. These comments
inappropriately assumed that the issue before the Agency in this action
was the establishment of a new or revised arsenic human health
criterion rather than whether it is scientifically defensible to apply
the 50 g/l value for arsenic as the applicable criterion for
CWA purposes. EPA is not developing or recommending a revised arsenic
Clean Water Act section 304(a) human health criterion in this action.
EPA's water quality standards regulation provides that in
establishing criteria, States should establish numerical values that
may be based on EPA's section 304(a) criteria guidance or ``other
scientifically defensible methods.'' (See 40 CFR 131.11(b).) EPA's
responsibility in this action is to determine the scientific
defensibility of Alaska's arsenic value as a human health water quality
criterion.
EPA's analysis for this rule considered reasonable estimates of
doses not only for typical consumers of drinking water and aquatic
life, but also for highly exposed populations. These populations
include persons who not only consume water with high arsenic
concentrations, but who also consume large amounts of fish and
shellfish captured from waters with significant to high arsenic
concentrations. EPA is satisfied that its calculations demonstrate that
application of the 50 g/l value in Alaska's water quality
standards will provide protection to typical consumers of water and
aquatic life in Alaska. EPA also recognizes that in some cases site
specific procedures will be needed to protect consumers where
extraordinary combinations of high arsenic concentrations in drinking
water and high fish and shellfish consumption occur. EPA will rely on
the state to use the site specific procedures in their policy cited
above to reduce arsenic intakes to acceptable levels. EPA believes that
the technical document developed for this
[[Page 10143]]
rulemaking, which has been externally peer reviewed, satisfies its
responsibilities to ascertain the scientific defensibility of using the
50 g/l value for arsenic as the human health criterion for
Alaska's freshwater. See, for example, NRDC v. EPA, 806 F. Supp. 1263
(E.D. Va., 1992).
Applicability in Indian Country
The National Toxics Rule criteria promulgated by EPA for
application in Alaska are applicable only to the waters of the state.
EPA did not intend to include Indian Country in that promulgation and
thus Indian Country was not mentioned in the NTR preamble or rule.
Thus, this final rule removing the applicability to Alaska's waters of
EPA's NTR human health arsenic criteria only affects waters of Alaska,
and does not affect any waters in Indian Country.
Executive Order 12866
Under Executive Order 12866 (58 FR 51735, October 4, 1993), the
Agency must determine whether a 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 a
``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 Presidents priorities, or of the principles set forth in
the Executive Order.
The withdrawal of the applicability of the arsenic human health
criteria to the waters of Alaska imposes no additional regulatory
requirements. Therefore, it has been determined that this rule is not a
``significant regulatory action'' under the terms of Executive Order
12866 and is not subject to OMB review.
Unfunded Mandates Reform Act
Title II of the Unfunded Mandates Reform Act of 1995 (UMRA), Pub.
L. 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 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. EPA is withdrawing the applicability
of a federal rule to the State of Alaska and therefore does not impose
any additional regulatory requirements or result in the annual
expenditure of $100 million or more for state, local or tribal
governments, in the aggregate, or to the private sector; and is not a
federal mandate, as defined by the UMRA, nor does it uniquely affect
small governments in any way. As such, the requirements of sections
202, 203, and 205 of Title II of the UMRA do not apply to this action.
National Technology Transfer and Advancement Act
Under section 12(d) of the National Technology Transfer and
Advancement Act, the Agency is required to use voluntary consensus
standards in its regulatory activities unless to do so would be
inconsistent with applicable law or otherwise impractical. ``Voluntary
consensus standards'' are ``technical standards'' (e.g., materials
specifications, test methods, sampling procedures, business practices,
management systems practices, etc.) which are developed or adopted by
voluntary consensus standard bodies. Where available and potentially
applicable voluntary consensus standards are not used by EPA, the Act
requires the Agency to provide Congress, through the Office of
Management and Budget, an explanation of the reasons for not using such
standards.
This rule withdraws human health water quality criteria for arsenic
promulgated by EPA for the state of Alaska. The rule does not prescribe
any substantive control standards, including any ``technical
standards'' within the meaning of the NTTAA. Accordingly, this rule is
not subject to the NTTAA.
Regulatory Flexibility Act
Under the Regulatory Flexibility Act (RFA), EPA generally is
required to conduct a regulatory flexibility analysis describing the
impact of the regulatory action on small entities as part of
rulemaking. However, under section 605(b) of the RFA, if EPA certifies
that the rule will not have a significant economic impact on a
substantial number of small entities, EPA is not required to prepare an
RFA. Pursuant to section 605(b) of the RFA, 5 U.S.C. 605(b), the
Administrator certifies that this rule will not have a significant
economic impact on a substantial number of small entities. EPA has not
prepared a final regulatory flexibility analysis for this action
because the agency has determined that this action is deregulatory in
nature and would impose no additional regulatory requirements or costs.
Therefore, pursuant to section 605(b) of the Regulatory Flexibility
Act, the Administrator certifies that this action will not have a
significant economic impact on a substantial number of small entities.
Paperwork Reduction Act
The Paperwork Reduction Act, 44 U.S.C. 3501 et seq. places
requirements on the Agency to estimate projected costs and reporting
burdens for information collection requirements included in proposed
and final rules. Any such requirements are subject to approval by the
Office of Management and Budget. This final rule does not impose any
requirement subject to the Paperwork Reduction Act because the action
withdraws the applicability of a
[[Page 10144]]
federal rule to the State of Alaska and does not place any reporting
requirements on the state.
Submission to Congress and the General Accounting Office
Under 5 U.S.C. 801(a)(1)(A) as added by the Small Business
Regulatory Enforcement Fairness Act of 1996, EPA submitted a report
containing this rule and other required information to the U.S. Senate,
the U.S. House of Representatives and the Comptroller General of the
General Accounting Office prior to publication of the rule in today's
Federal Register. This rule is not a ``major rule'' as defined by 5
U.S.C. 804(2).
List of Subjects in 40 CFR Part 131
Environmental protection, Water pollution control, Water quality
standards.
Dated: February 23, 1998.
Carol M. Browner,
Administrator.
For the reasons set out in the preamble, Title 40, Chapter I, part
131 of the Code of Federal Regulations is amended as follows:
PART 131--WATER QUALITY STANDARDS
1. The authority citation for part 131 continues to read as
follows:
Authority: 33 U.S.C. 1251 et seq.
Sec. 131.36 [Amended]
2. In Section 131.36(d)(12)(ii) the table is amended under the
heading ``Applicable Criteria'', in the entry for ``Column D1'' and
three entries for ``Column D2'' by removing the number ``2'' from the
list of numbers.
[FR Doc. 98-5091 Filed 2-27-98; 8:45 am]
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