[Federal Register Volume 59, Number 243 (Tuesday, December 20, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-30953]
[[Page Unknown]]
[Federal Register: December 20, 1994]
_______________________________________________________________________
Part II
Environmental Protection Agency
_______________________________________________________________________
40 CFR Parts 141, 142, and 143
_______________________________________________________________________
National Primary Drinking Water Regulations--Sulfate; Proposed Rule
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Parts 141, 142 and 143
[WH-FRL-5120-7]
RIN 2040-AC07
Drinking Water; National Primary Drinking Water Regulations--
Sulfate; National Primary Drinking Water Regulation Implementation
AGENCY: Environmental Protection Agency (EPA).
ACTION: Proposed rule.
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SUMMARY: By this action, EPA is reproposing a maximum contaminant level
goal (MCLG), and a National Primary Drinking Water Regulation (NPDWR)
including a maximum contaminant level (MCL) for sulfate. There is a
potential for an adverse health effect for infants, travelers, and new
residents in areas that have high sulfate levels in their drinking
water. The objective of this rule is to ensure that sulfate levels in
drinking water provided by public water systems are reduced below
levels of concern. The proposal contains alternatives that allow public
water systems the flexibility to select compliance options appropriate
to protect the population served.
DATES: Comments must be received on or before March 21, 1995. Comments
received after this date may not be considered. A public hearing on the
proposal will be held in Washington, DC on February 2, 1995 at the
address listed below under ADDRESSES.
ADDRESSES: The Agency will hold a public hearing on the proposal at the
following location: EPA Education Center Auditorium, 401 M Street SW.,
Washington, DC 20460, on February 2, 1995.
The hearing will begin at 9:30 am, with registration at 9 am. The
hearing will end at 4 pm, unless concluded earlier. Anyone planning to
attend the public hearing (especially those who plan to make
statements) may register in advance by writing the Sulfate Public
Hearing Officer, Office of Ground Water and Drinking Water (4603),
USEPA, 401 M Street SW., Washington, DC 20460; or by calling Tina
Mazzocchetti, (703) 931-4600. Oral and written comments may be
submitted at the public hearing. Persons who wish to make oral
presentations are encouraged to have written copies (preferably three)
of their complete comments for inclusion in the official record.
Send written comments to the Sulfate Docket Clerk, Water Docket
(MC-4101), U.S. Environmental Protection Agency, 401 M Street, SW.,
Washington, DC 20460. Please submit any references cited in your
comments. EPA would appreciate an original and three copies of your
comments and enclosures (including references). Commenters who want EPA
to acknowledge receipt of their comments should include a self-
addressed, stamped envelope. No facsimiles (faxes) will be accepted
because EPA cannot ensure that they will be submitted to the Water
Docket.
The proposed rule with supporting documents, including public
comments and EPA responses to the Phase V rulemaking and this proposed
rule, are available for review at the Water Docket at the address
above. For access to Docket materials, call (202) 260-3027 between 9 am
and 3:30 pm for an appointment.
FOR FURTHER INFORMATION CONTACT: The Safe Drinking Water Hotline,
telephone 800-426-4791. The Hotline is open Monday through Friday,
excluding Federal holidays, from 9 am to 5:30 pm Eastern Standard Time.
For technical inquiries, contact Jude Andreasen, Drinking Water
Standards Division, Office of Ground Water and Drinking Water (4603),
U.S. Environmental Protection Agency, 401 M Street, SW., Washington, DC
20460, 202-260-5555, or one of the EPA Regional Office contacts listed
under Supplementary Information.
SUPPLEMENTARY INFORMATION: The Agency prefers that commenters type or
print comments in ink, and cite, where possible, the paragraph(s) in
this proposed regulation (e.g., Sec. 141.32(b)) to which each comment
refers. Commenters should use a separate paragraph for each issue
discussed. Technical inquiries can be directed to the contacts in
regional offices as follows:
I. JFK Federal Bldg., Room 2203, One Congress Street, 11th floor,
Boston, MA 02203, Phone: (617) 565-3484, Jerome Healey
II. 26 Federal Plaza, Room 824, New York, NY 10278, Phone: (212)
264-1800, Walter Andrews
III. 841 Chestnut Street, Philadelphia, PA 19107, Phone: (215) 597-
8826, Stuart Kerzner
IV. 345 Courtland Street, NE., Atlanta, GA 30365, Phone: (404) 347-
2207, Wayne Aronson
V. 77 West Jackson Boulevard, Chicago, IL 60604, Phone: (312) 353-
2151, Ed Watters
VI. 1445 Ross Avenue, Dallas, TX 75202, Phone: (214) 655-7150, Tom
Love
VII. 726 Minnesota Ave., Kansas City, KS 66101, Phone: (913) 551-
7032, Ralph Langemeier
VIII. One Denver Place, 999 18th Street, Suite 500, Denver, CO
80202-2466, Phone: (303) 293-1652, Patrick Crotty
IX. 75 Hawthorne Street, San Francisco, CA 94105, Phone: (415) 744-
1817, Loretta Barsamian
X. 1200 Sixth Avenue, Seattle, WA 98101, Phone: (206) 553-4092,
Kenneth Feigner
Table of Contents
I. Summary of Today's Action
II. Background
A. Statutory Authority
B. Regulatory History
C. Sulfate General Information
III. Explanation of Today's Action
A. Establishment of MCLG for Sulfate
1. Health Effects
2. Occurrence and Human Exposure
3. Previously Proposed MCLG Public Comments, EPA Response
4. Today's Proposed MCLG
B. Establishment of NPDWR for Sulfate
1. Methodology for Determination of MCLs
2. Treatment Technologies and Costs
3. Sulfate Analytical Methods
a. Choice of Analytical Method
b. Method Detection Limits and Practical Quantitation Levels
c. Sulfate Sample Preservation, Container, and Holding Times
d. Laboratory Certification
e. Setting PE Sample Acceptance Limits for Sulfate
4. Establishment of an NPDWR
a. Today's Proposed MCL
b. Lead Option for Implementing the MCL Requirement
c. Method of Compliance
(1) Community Water Systems
(i) Bottled Water
(ii) Public education/notification
(2) Transient and Not-Transient, Non-Community Systems
(i) Bottled Water and POU/POE Devices
(ii) Public education/notification
(3) Rationale
d. Other Options Being Considered
e. Implications of Options 1, 2 and 3
f. Option 4
g. Additional Option
5. Compliance Monitoring Requirements
a. Introduction
b. Proposed Monitoring Requirements for Sulfate
(1) Bottled Water
(2) POU/POE Devices
(3) Effective Date for Initial Monitoring
(4) Sampling Location
(5) Monitoring Frequency
(6) Public Notice Requirements
c. State Implementation
(1) State Primacy Requirements
(2) State Recordkeeping Requirements
(3) State Reporting Requirements
d. Variances and Exemptions
(1) Variances
(2) Exemptions
IV. Economic Analysis
A. Executive Order 12866
B. National Costs of the Proposed Rule
1. Assumptions Used to Estimate Costs
2. Costs to Households
3. Assumptions Used to Estimate Benefits
C. Comparison to Earlier Proposed Rule
D. Annual Burden to PWSs and States
V. Summary of Selected Issues
VI. Other Requirements
A. Regulatory Flexibility Analysis
B. Paperwork Reduction Act
C. Enhancing the Intergovernmental Partnership
VII. References
Abbreviations Used in This Document
ASDWA: Association of State Drinking Water Administrators
BAT: Best Available Technology
BTGA: Best Technology Generally Available
CRAVE: Cancer Risk Assessment Verification Endeavor
CWS: Community Water System
DWEL: Drinking Water Equivalent Level
ED: Electrodialysis
EIA: Economic Impact Analysis
EPA: Environmental Protection Agency
FDA: Food and Drug Administration
FR: Federal Register
FRDS: Federal Reporting Data System
ICR: Information Collection Request
IE: Ion Exchange
IOC: Inorganic Chemical
IRIS: Integrated Risk Information System
LCP: Laboratory Certification Program
LOAEL: Lowest-Observed-Adverse-Effect Level
MCL: Maximum Contaminant Level (expressed as mg/L) (1,000 micrograms
(g) = 1 milligram (mg))
MCLG: Maximum Contaminant Level Goal
MDL: Method Detection Limit
NAS: National Academy of Science
NCWS: Non-Community Water System
NIRS: National Inorganics and Radionuclides Survey
NOA: Notice of Availability
NOAEL: No-Observed-Adverse-Effect Level
NOEL: No-Observed-Effect Level
NPDWR: National Primary Drinking Water Regulation
NTIS: National Technical Information Service
NTNCWS: Non-Transient Non-Community Water System
O&M: Operations & Maintenance
OMB: Office of Management and Budget
PE: Performance Evaluation
POE: Point-of-Entry Device
POU: Point-of-Use Device
PQL: Practical Quantitation Level
PWS: Public Water System
RFA: Regulatory Flexibility Analysis
RfD: Reference Dose
RIA: Regulatory Impact Analysis
RMCL: Recommended Maximum Contaminant Level
RO: Reverse Osmosis
RSC: Relative Source Contribution
RWS: Rural Water Survey
SDWA: Safe Drinking Water Act, or the ``Act,'' as amended in 1986
SMCL: Secondary Maximum Contaminant Level
SMF: Standardized Monitoring Framework
SOC: Synthetic Organic Chemical
T&C: Technology & Costs
TWS: Transient Non-Community Water System
URTH: Unreasonable Risk To Health
VOC: Volatile Organic Chemical
WS: Water Supply
List of Tables
Table 1--Proposed MCLG, BAT and Analytical Methods
Table 2--Compliance Monitoring Requirements
Table 3--Annual Costs of Proposed 1412 BAT
Table 4--Proposed Analytical Methods for Sulfate
Table 5--Proposed Methodology and Detection Limits for Sulfate
Table 6--Sulfate Sample Preservation, Container, and Holding Time
Requirements
Table 7--Number of Systems Expected to Exceed 500 mg/L
Table 8--National Annual Sulfate Costs For Options 1-4
Table 9--Average Annualized Costs for Households
Table 10--Assumptions Made in Estimating Benefits
Table 11--Annual Burden Hours
I. Summary of Today's Action
Today the Agency is proposing an MCLG of 500 mg/L, an MCL of 500
mg/L, and other NPDWR requirements for sulfate. Sulfate is a unique
contaminant for several reasons. The health effect associated with the
ingestion of relatively high levels of sulfate in drinking water (i.e.,
ranging from loose stools to diarrhea) is acute and temporary, and is
expected to last approximately two weeks. In addition, the health risk
only applies to persons not already acclimated to high sulfate-
containing water: infants, travelers, and new residents. (For the
purposes of this rule, infants are defined as children up to the age of
12 months.) Today's proposed rule is also unique because it affects all
public water systems, that is, community water systems, traveler non-
community water systems, and non-transient, non-community water
systems. In the past, only regulations on microbial contaminants and
nitrate have affected transient, non-community systems.
EPA decided to defer promulgation of a sulfate standard, originally
proposed July 25, 1990 (55 FR 30370) in order to identify an
implementation approach which was tailored to the target populations.
The approach EPA developed, working in cooperation with several States
at a 1992 meeting, is innovative, and was designed specifically to
provide flexibility to smaller systems. This approach could reduce
compliance costs while still providing adequate protection of public
health. It provides public water systems a means of compliance which is
less expensive than central treatment, and it affords States
flexibility in implementing the rule. Under this approach, the State
would have the authority to allow the public water system (PWS), as one
means of compliance with the sulfate MCL, to provide ``Alternative
Water'' and public education/notification to the targeted, sensitive
population. A PWS authorized to comply under this option would choose
to supply customers with ``Alternative Water'', defined as either
bottled water which has been monitored or certified to be in compliance
with all EPA MCLs, or water treated by point-of-use (POU) or point-of-
entry (POE) devices.
In the interest of reducing costs and maximizing flexibility, the
proposal allows for unique means of compliance. Four options are being
proposed for public comment. The lead option requires provision of
alternative water to both transient adults (travelers and new
residents) and infants. Two variations of the lead option require
provision of alternative water to infants only. These two options
differ only in the content of the public notification. In one case,
only infants are considered at risk, and temporary diarrhea is
considered as only an inconvenience for adults. In the other, both
adults and infants are considered at risk, but public notification is
deemed sufficient protection for adults. Because the lead option and
its two variations represent a significant change in regulatory
approach, EPA considered another, more conventional option. This fourth
option would enable systems to seek a variance from the sulfate MCL. As
a condition of receiving a variance, systems would be required to
provide alternative water to their target populations, just as in the
lead option. The only difference is that the relief for small systems
would be provided through a different statutory mechanism. The Agency
also considered limiting compliance to central treatment, which would
be consistent with the approach for other contaminants, but which would
not provide flexibility for smaller systems.
The Agency expects that approximately 1,500 of the 2,000 affected
systems would choose the lead option (Option 1) if it were available to
them. The annual cost to those systems is estimated to be $7 million.
The Agency has conservatively assumed that the remaining 500 systems
would choose central treatment or regionalization in spite of the
availability of Option 1. The cost to those systems is estimated to be
$71 million. Total national cost of Option 1, including $8 million for
State implementation and monitoring costs, is $86 million. If central
treatment were the only means of compliance with the sulfate rule, the
annual national cost would be $147 million (household costs ranging
from $244 to $811). Household costs for Option 1 range from $106 to
$287 per year, but this is an average of all households in all systems,
including those choosing central treatment.
In an effort to reduce the cost of this rule even further, the
Agency is giving serious consideration to variations of Option 1. These
variations, described as Options 2 and 3, would require public
notification/education, but would only require the provision of bottled
water which complies with EPA MCLs to infants. The difference between
Options 2 and 3 is that Option 2 would target only infants as being at
risk from an adverse effect, and Option 3 would target both adults and
infants, but would propose that public notification/education is
sufficient protection for adults. The Agency sees advantages and
disadvantages to these alternative options, which are discussed later
in this notice. The cost for either option would be $16 million, which
includes $8 million for State implementation and monitoring costs.
Household costs for these two options would be from $2 to $145 per
year.
EPA also considered Option 4, which would achieve the same result
as Option 1, but with different administrative procedures involving a
variance from the sulfate MCL. Under Option 4, the regulation would
specify that the conditions for States to grant a variance from the
sulfate MCL would include the same elements described for Option 1,
namely public notification/education and Alternative Water provisions.
These elements would be defined as BAT only for the purposes of Section
1415 of the SDWA. The Agency believes that the unique nature of the
sulfate health effect warrants a more flexible perspective on the
implementation of the Act. The Agency recognizes that while the
transitory nature of the diarrhetic effect of high-sulfate water may be
uncomfortable and inconvenient for healthy adults, the potential risk
to infants of diarrhea, as well as the dehydration and electrolyte
imbalance which may be associated with it, are significant and
potentially fatal if untreated.
Table 1.--Proposed MCLG and MCL for Sulfate
Inorganic Contaminant.............. Sulfate
Proposed MCLG...................... 500 mg/L\1\
Proposed MCL....................... 500 mg/L
Best Available Technologies........ Reverse Osmosis (RO)
Ion Exchange\2\ (IE)
Electrodialysis (ED)
Analytical Methods\3\.............. Colorimetry
Gravimetry
Ion Chromatography
\1\An alternative MCLG/MCL option of 400 mg/L was proposed in the July
25, 1990 notice but is not proposed here.
\2\For those systems with other anions that need to be removed (such as
nitrate), the removal efficiency will decrease for those anions since
sulfate binds more strongly to the exchange resin than other anions.
\3\Acceptance limits=15% at 10 mg/L.
Table 2.--Compliance Monitoring Requirements\1\ For Systems Below the MCL, or With BAT Installed
----------------------------------------------------------------------------------------------------------------
Base requirement Trigger that
Contaminant -------------------------------------------------- increases Waivers
Ground water Surface water monitoring
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Sulfate................. 1 Sample/3 yr.......... Annual sample.......... > MCL Yes\2\
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\1\The compliance monitoring requirements apply to community water systems, transient non- community and non-
transient non-community water systems.
\2\Sample/9 Years After 3 Samples < MCL.
The options in today's proposal would override the general
prohibition in 40 CFR 141.101 on using bottled water which complies
with EPA MCLs and point-of-use devices to achieve compliance with an
MCL. This override would apply only to sulfate because of its unique
characteristics.
II. Background
A. Statutory Authority
The Safe Drinking Water Act (SDWA or ``the Act''), as amended in
1986 (Pub. L. No. 99-339, 100 Stat. 642), requires EPA to publish
``maximum contaminant level goals'' (MCLGs) for contaminants which, in
the judgment of the Administrator, ``may have any adverse effect on the
health of persons and which (are) known or anticipated to occur in
public water systems'' (Section 1412(b)(3)(A)). MCLGs are to be set at
a level at which ``no known or anticipated adverse effects on the
health of persons occur and which allows an adequate margin of safety''
(Section 1412(b)(4)).
Concurrent with EPA publishing an MCLG, which is a non-enforceable
health goal, it must promulgate a National Primary Drinking Water
Regulation (NPDWR) which includes either:
(1) an MCL, or (2) a required treatment technique (Section 1401(1),
1412(a)(3), and 1412(b)(7)(A)).
An MCL must be set as close to the MCLG as feasible (Section
1412(b)(4)). Under the Act, ``feasible'' means ``feasible with the use
of the best technology, treatment techniques and other means which the
Administrator finds, after examination for efficacy under field
conditions and not solely under laboratory conditions (taking cost into
consideration)'' (Section 1412(b)(5)). In setting MCLs, EPA considers
the cost of treatment technology to large public water systems (i.e.,
>1,000,000 people) with relatively clean source water supplies (132
Cong. Rec. S6287 (daily ed., May 21, 1986)).\1\ Each NPDWR that
establishes an MCL must list the best available technology, treatment
techniques, and other means that are feasible for meeting the MCL
(Section 1412(b)(6)). NPDWRs include monitoring, analytical and quality
assurance requirements, specifically, ``criteria and procedures, to
assure a supply of drinking water which dependably complies with such
maximum contaminant levels * * *.'' (Section 1401(1)(D)). Section 1445
also authorizes EPA to promulgate monitoring requirements.
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\1\EPA also evaluates the costs to smaller systems in its
analysis of economic impacts.
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A treatment technique may be required if it is not ``economically
or technologically feasible'' to ascertain the level of a contaminant
(Sections 1401(1) and 1412(b)(7)(A)).
Section 1414(c) requires each owner or operator of a PWS to give
notice to persons served by it of (1) any failure to comply with a
maximum contaminant level, treatment technique, or testing procedure
required by a NPDWR; (2) any failure to comply with any monitoring
required pursuant to section 1445 of the Act;
(3) the existence of a variance or exemption; and
(4) any failure to comply with the requirements of any schedule
prescribed pursuant to a variance or exemption.
Under the 1986 Amendments to the SDWA, EPA was to complete the
promulgation of NPDWRs for 83 listed contaminants, including sulfate,
by June 19, 1989. After 1989, an additional 25 contaminants must be
regulated every three years (section 1412(b)).
In the 1986 Amendments to the SDWA, Congress required that MCLGs
and MCLs be proposed and promulgated simultaneously (section
1412(a)(3)). This change streamlined development of drinking water
standards by combining two steps in the regulation development process.
Section 1412(a)(2) renamed recommended maximum contaminant levels
(RMCLs) as maximum contaminant level goals (MCLGs).
B. Regulatory History
EPA is required by the 1986 amendments to the SDWA to issue a
proposed and final standard for sulfate. EPA grouped sulfate with 23
other organic and inorganic compounds in the ``Phase V'' regulatory
package proposal. The 24 contaminants were among the last of the
original list of 83 to be regulated by the SDWA. On June 25, 1990 EPA
proposed the Phase V regulation, including sulfate (published at 55 FR
30370, July 25, 1990). In the notice, EPA described the health effects
associated with sulfate (see 55 FR 30382-83). The notice stated that
the available scientific information suggests that an adverse health
effect from ingesting high levels of sulfate is diarrhea and associated
dehydration. Because local populations usually acclimate to high
sulfate levels, the impact is primarily on infants, transient
populations (e.g., business travelers, visitors and vacationers), and
new residents. In the 1990 notice, EPA proposed alternative levels of
400 mg/L and 500 mg/L for the MCLG for sulfate.
In the Fall of 1991, as EPA was nearing publication of regulations
for the 24 Phase V contaminants, it became apparent that the Agency had
not reached a consensus on how to proceed with the sulfate regulation
in light of concerns raised by the commenters. Given the high cost of
the rule, the relatively low risk, and the need to explore alternative
regulatory approaches targeted at the transient consumer, EPA decided
to seek a deferral of a final regulatory decision on sulfate. The
Agency needed more time to resolve issues that included: (1) Whether
additional research is needed on how long it takes infants to acclimate
to water with high sulfate content, (2) whether new regulatory
approaches were needed for regulating a contaminant whose health effect
is confined largely to transient populations, and (3) whether the
Agency should revise its definition of BAT for small systems (i.e.,
what should be considered affordable for the small, transient non-
community water systems). For the above reasons, the regulation on
sulfate was deferred. A new schedule has been established in connection
with litigation brought over the schedule for regulating sulfate. This
schedule requires EPA to finalize its regulatory action for sulfate by
May 1996.
The secondary maximum contaminant level (SMCL) for sulfate is 250
mg/L and is based on aesthetic effects (i.e., taste and odor). EPA is
not proposing changes in the SMCL for sulfate, but is requesting public
comment on the correlation between sulfate concentrations,
palatability, and consumption of high-sulfate water by the public.
C. Sulfate General Information
Sulfate is the divalent anion (SO4-2). It exists in a
variety of inorganic compounds and salts formed with metal cations.
Sulfate salts with lower molecular weight alkali metals such as sodium,
potassium, and magnesium are very water soluble and are often found in
natural waters. Salts of higher molecular weight metals such as barium,
iron or lead have very low water solubility.
Sulfate is found in soil sediments and rocks, and occurs in the
environment as a result of both natural processes and human activities.
Specific data on the total production of all sulfates are not
available, but production is expected to be thousands of tons per year;
the use of sodium sulfate alone in 1987 was reported to be 792 tons.
Sulfate is used for a variety of commercial purposes, including pickle
liquor (sulfuric acid) for steel and metal industries, and as a reagent
in manufacturing of products such as copper sulfate (a fungicide/
algicide).
Sulfate may enter surface and ground water as a result of discharge
or disposal of sulfate-containing wastes. In addition, sulfur oxides
produced during the combustion of fossil fuels are transformed to
sulfuric acid in the atmosphere. Through precipitation (i.e., acid
rain), sulfuric acid can enter surface waters, lowering the pH and
raising sulfate levels.
III. Explanation of Today's Action
A. Establishment of MCLG for Sulfate
The MCLG for sulfate is reproposed today at a level of 500 mg/L. In
this notice, EPA is responding to the public comments submitted in
reference to the MCLG options contained in the July 1990 proposal.
EPA's complete responses to the public comments on the previously
proposed MCLGs appear in the Comment/Response Document that is included
in the docket for this rulemaking.
MCLGs are set at concentration levels at which no known or
anticipated adverse health effects occur, allowing for an adequate
margin of safety. The process for establishing an MCLG for a
contaminant has been described in many documents, including the final
Phase V rule issued in July 1992 (57 FR 31781-31783).
1. Health Effects
The available information on the health effects of sulfate was
fully described in the July 25, 1990 (55 FR 30370) Phase V proposal.
Studies mentioned in that notice are summarized in the Health Criteria
Document for Sulfate (US EPA, 1992), which is available for review and
comment in the docket for this rulemaking. Since that time, EPA has
funded additional studies on humans and piglets which are currently
under review.
In the July 25, 1990 notice, EPA stated that there was no evidence
of adverse health effects in animals or humans from chronic exposure to
sulfate in drinking water. The available health data indicate that
chronic exposure to sulfate is not harmful to health.
The acute effects noted from exposure to high levels of sulfate
range from soft stools to diarrhea. Infants may be more sensitive to
sulfate than healthy adults. Infants consume more water and food on a
body weight basis than adults, and consequently ingest a higher dose of
sulfate (per body weight) in drinking high-sulfate water than do
adults. In infants, the greatest risk is from dehydration and
electrolyte imbalance that may result from diarrhea. This effect can be
fatal if untreated.
It has been questioned whether the concentration of sulfate found
in drinking water would cause significant dehydration in infants or
adults. Schild (1980) reported that eight grams of sulfate retain 120
milliliters of water in the intestine. In this case, an adult drinking
two liters of water containing 1500 milligrams of sulfate per liter
would ingest three grams of sulfate and retain 45 milliliters of water
in the intestine. The Agency is requesting any scientific data which
would support or refute the hypothesis that this decrease in available
water is likely to cause dehydration and electrolyte imbalance in
adults or infants.
There are three documented case histories of infants, 5 to 12
months old, who were given formulas prepared with water containing 630
to 1,150 mg/L of sulfate (Chien, et al., 1968). These infants developed
diarrhea shortly after they ingested the formula, but the effect
subsided after use of the high sulfate water was discontinued. Cole
(1992) evaluated this study and concluded that neither the potential
effects of osmolarity, specifically hyperosmolarity, nor viral
gastroenteritis had been considered as possible causes of the observed
diarrhea. Thus, Cole suggested and the Agency agrees that the Chien
study provides qualitative evidence of the effects of sulfate but
should not be used quantitatively in a sulfate risk assessment.
Similar effects have been observed in adults, but individuals seem
to become acclimated to high sulfate levels in a short period of time,
with a cessation of all ill effects.
The laxative effect of sulfate is well-known. Peterson (1951)
compiled the results of questionnaires sent to North Dakota residents
and concluded that ``waters with 600 to 750 ppm sulfates should be
looked upon with suspicion as they may or may not be laxative. Over 750
ppm sulfates is generally a laxative water and below 600 ppm sulfates
should be considered safe.'' Moore (1952) replotted the Peterson data
and found that as sulfate concentrations increased from 500 to 1000 mg/
L, the number of adults reporting laxative effects also increased. At
concentrations of sulfate above 1,000 mg/L, the majority of respondents
noted a laxative effect. While it is not known how long is needed to
achieve acclimation in adults or infants, EPA scientists believe the
time to be approximately two weeks, based on mucosal cell turnover rate
in the intestines.
The Agency is using these studies to support the MCLG, although
each has limitations. For example, in the Peterson (1951) study, there
is no information available on the chemical composition or the
microbiological quality of the water, nor on the length of time that
people drank the water.
There are insufficient data to calculate a precise and reliable
quantification of the exact dose which will cause diarrhea in a given
percentage of the susceptible population. Some sulfate salts are used
as laxative agents. Their mechanism of action is known, and there is
apparently little interest in the medical community in additional
research on the subject. Acclimation to sulfate is assumed due to the
fact that people living in regions with high-sulfate drinking water
seem to have no adverse effect, whereas newcomers drinking that
region's water will initially experience the laxative effect.
In developing the MCLG for sulfate, issues were raised concerning
the ability of infants to acclimate to sulfate in drinking water. In
1992, EPA convened an expert panel to discuss the sulfate data base (US
EPA, 1992). The panel (D.E.C. Cole, Children's Hospital, Halifax, Nova
Scotia; M. Cassidy, George Washington University, Washington, DC; and
M. Morris, State University of New York, Amherst, NY) concluded that
the lack of data on the sulfate content and the osmolarity of the
formulas used in the Chien et al. (1968) study prevents it from being a
reliable estimate of the level of sulfate that would induce diarrhea in
infants. They concluded that: (1) Additional studies on sulfate are
desirable, (2) the Chien et al. (1968) study cannot be used
quantitatively, (3) the 500 mg/L value for sulfate is conservative for
adults, and there are no differences between sulfate levels of 400 and
500 mg/L, (4) the three cases of diarrhea reported in the Chien study
may or may not be attributable to sulfate, and (5) acute short-term
effects are the appropriate focus for risk assessment and further
research.
The panel members recommended additional research with piglets and
humans. EPA agreed and initiated studies in collaboration with the
University of North Carolina School of Medicine and the North Carolina
State University Department of Animal Science. These studies have been
completed and are undergoing internal and external peer review.
2. Occurrence and Human Exposure
The available information on the occurrence and human exposure to
sulfate was fully described in the July 25, 1990 proposal. Since that
time, additional State data have been gathered and used to update the
information in Table 8.
Review of data sources for estimating national occurrence levels of
sulfate included: The Community Water Supply Study (CWSS) released in
1969; the Rural Water Survey (RWS) from the late 1970s; new State
survey data from Utah, North and South Dakota, and Texas: The Federal
Reporting Data System (FRDS) and STORET, EPA's computerized water
quality data base. In the CWSS, 106 surface water supplies sampled had
an apparent detection limit of 1 mg/L. For the ground water supplies
the mean of the positive sulfate detections was approximately 43 mg/L
(range of 1 to 480 mg/L), and for surface water it was approximately 49
mg/L (range of 2 to 358 mg/L). The Rural Water Survey (RWS) reported a
lower frequency of positives and a higher mean of the positive values,
but this lower frequency probably reflects the higher detection limit
of 15 mg/L. In the RWS, sulfate was reported to be present in 271 of
494 ground water supplies with a mean of about 98 mg/L (range of 10 to
1,000 mg/L) for the positives (some laboratories can achieve accuracy
at levels lower than the published detection limit of 15 mg/L). In
surface water, it was found in 101 of 154 supplies, with a mean of 53
mg/L (range of 15 to 321 mg/L) for the positives.
As noted above, sulfate can be formed in the atmosphere, and EPA
has reported ambient levels during the period of 1980-1986 to range
from 0.2 to 199.4 g/m\3\. Since the amounts of sulfate that
could be transferred from the atmosphere through the pulmonary system
to the gastrointestinal tract are minuscule compared to what could be
ingested in drinking water, atmospheric levels are not of concern for
the purposes of this rule.
No information is available on the occurrence of sulfate in foods,
nor are there any estimates on dietary intake. The Agency did not
follow its usual practice of determining a relative source contribution
(RSC) factor. As with certain other inorganic contaminants (nitrate,
fluoride, barium, manganese), calculation of RSC is not appropriate for
sulfate because the MCLG is derived directly from human exposure to the
contaminant in drinking water.
3. Previously Proposed MCLG
In July 1990, EPA proposed two alternative options for the sulfate
MCLG based on the available health information. The first option was to
set the MCLG at 400 mg/L, based on a Science Advisory Board (SAB)
conclusion that sulfate's mode of action is well known and some human
data are available indicating that ill effects occur only at
concentrations above 600 mg/L (Peterson, 1951). SAB applied a small
uncertainty factor of 1.5 to the 600P mg/L level to give a recommended
MCLG of 400 mg/L. Their recommendation corresponded to the World Health
Organization (WHO) sulfate standard of 400 mg/L, which is based on
aesthetic considerations.
The second option was to set the MCLG at 500 mg/L. As a basis for
choosing this option, EPA referred to the survey conducted by Peterson
(1951) and evaluated by Moore (1952). Combining the questionnaire
respondents into discrete groups, Moore indicated that the number of
adults reporting laxative effects increased at sulfate concentrations
above 500 mg/L.
The Health Protection Branch of Health and Welfare/Canada has
indicated to EPA (Canadian Guidelines, 1991) that the maximum
acceptable concentration of sulfate in water is 500 mg/L, considered an
aesthetic objective, since ``at this level sulfate gives an
objectionable taste, but is still below the level at which we would
expect to see deleterious health effects''. The Agency notes that the
Canadian sulfate guideline of 500 mg/L and the lack of health problems
reported at that level lends support to the proposed MCLG. Canada does
not yet have national drinking water regulations. Their guidelines are
offered to the provinces, which may choose to adopt them as provincial
regulations.
Public Comments
There were 15 separate comments concerning sulfate on the 1990
proposed rule. Several commenters believed that EPA should not regulate
sulfate due to a lack of adequate health data, lack of chronic effects
and because people acclimate to the laxative effects of sulfate. Eleven
commenters stated that if it were necessary to regulate sulfate, that
the MCLG should be higher than 500 mg/L (between 600 and 1,000 mg/L).
The remaining four commenters stated that 500 mg/L was protective. One
commenter stated that the usual approach for deriving the MCLG--an RfD
calculation--should be used for sulfate. Another commenter cited a July
17, 1989 letter from the Metals Subcommittee of the Science Advisory
Board's Environmental Health Committee to the Administrator stating
that the Subcommittee could not support the setting of an acute MCLG,
and recommending additional study before regulation. Several commenters
urged EPA not to regulate sulfate, stating that a secondary MCL is
sufficient. They noted that infants as well as adults acclimate to
sulfate, sulfate is present in food, and the WHO guidelines are based
on taste considerations and not health effects. Several commenters
noted that systems which do not serve the target population, infants in
particular, should be excused from complying with the sulfate
regulation. Several commenters questioned EPA's cost analysis.
EPA Response
Some commenters noted that no chronic health effects have been
associated with long-term exposure to high levels of sulfate. However,
sulfate can have acute adverse effects on non-acclimated persons. The
population at risk is readily identified and targeted for protective
measures. While the laxative effect eases and disappears as the person
acclimates to the high sulfate concentration, the individual is subject
to debilitation during the acclimation period.
Diarrhea and/or laxative effects have been reported in infants
ingesting water with high levels of sulfate and in adults at
concentrations in the 500 to 1000 mg/L range. EPA believes an MCL level
of 500 mg/L will be sufficiently protective of infants and adults. An
RfD for sulfate has not been determined.
SMCLs for aesthetic qualities relating to the public acceptance of
drinking water are not federally enforceable, and intended only as
guidance for the States. SMCLs do not meet the statutory requirement to
set an NPDWR for sulfate.
The requirements for transient and non-transient, non-community
water systems which do not serve the target population frequently would
be minimal. They could achieve compliance by placing permanent signs at
drinking fountains and having bottled water which complies with EPA
MCLs available for visitors.
The Agency has updated the occurrence data and the cost analysis
since the Phase V proposal.
4. Today's Proposed MCLG
Today EPA is proposing an MCLG of 500 mg/L which represents the
level at which no known or anticipated adverse effects on human health
occur, and which allows for an adequate margin of safety based on
current data. As a basis for choosing this level, EPA notes that the
survey conducted by Peterson (1951) and evaluated by Moore (1952)
indicated that the number of people reporting laxative effects greatly
increased at sulfate concentrations above 500 mg/L. This concentration
is considered protective of infants based on the information reported
by Chien et al. (1968).
EPA believes that the MCLG for sulfate should be based on the
potential for causing loose stools and diarrhea. Infants are at risk
from diarrhea regardless of the cause, and unacclimated adults may also
be at risk. A standard to limit the intake of sulfate will protect the
infant population and unacclimated adults from potential adverse
effects.
EPA requests comment on this proposed MCLG. EPA particularly
requests any new data or any other new information that may be
submitted in support of or opposing the reproposed sulfate MCLG of 500
mg/L. In light of comments opposing the regulation of sulfate, the
Agency is also requesting any new data or information that would
support a higher level for the MCLG. The Agency is particularly
interested in comments that raise issues other than those that EPA has
already considered and responded to above and in the record for today's
proposal.
B. Establishment of NPDWR for Sulfate
1. Methodology for Determination of MCLs
The SDWA directs EPA to set the MCL ``as close to'' the MCLG ``as
is feasible.'' The term ``feasible'' means ``feasible with the use of
the best technology, treatment techniques, and other means, which the
Administrator finds, after examination for efficacy under field
conditions and not solely under laboratory conditions, are available
(taking costs into consideration)'', (SDWA section 1412(b)(5)). Each
NPDWR that establishes an MCL lists the technology, treatment
techniques, and other means which the Administrator finds to be
feasible for meeting the MCL (SDWA section 1412(b)(6)).
The present statutory standard for BAT under 1412(b)(5) represents
a change from the provision prior to 1986, which required EPA to judge
feasibility on the basis of ``best technologies generally available''
(BTGA). The 1986 Amendments to the SDWA changed BTGA to BAT and added
the requirement that BAT must be tested for efficacy under field
conditions, not just under laboratory conditions. The legislative
history explains that Congress removed the term ``generally'' to assure
that MCLs ``reflect the full extent of current technology capability''
(S. Rep. No. 56, 99th Cong., 1st Session at 6 (1985)). EPA has
concluded that the statutory term ``best available technology'' is a
broader standard than ``best technology generally available'' and that
this standard allows EPA to select a technology that is not necessarily
in widespread use, as long as its performance has been validated in a
reliable manner. In addition, EPA believes that the technology selected
need not necessarily have been field tested for each specific
contaminant but, rather, that the operating conditions may be projected
for a specific contaminant using a field tested technology from
laboratory or pilot systems data.
Based on the statutory directive for setting the MCLs, EPA derives
the MCLs based on an evaluation of (1) the availability and performance
of various technologies for removing the contaminant, and (2) the costs
of applying those technologies. Other technology factors considered in
determining the MCL include the ability of laboratories to measure
accurately and consistently the level of the contaminant with available
analytical methods.
EPA's initial step in deriving the MCL is to make an engineering
assessment of technologies that are capable of removing a contaminant
from drinking water. EPA reviews the available data to determine
technologies that have the highest removal efficiencies, are compatible
with other water treatment processes, and are not limited to a
particular geographic region.
Based on the removal capabilities of the various technologies, EPA
calculates the level of each contaminant that is achievable by their
application to large systems with relatively clean raw water sources.
(See H.R. Rep. 1185, 93rd Cong., 2nd Sess. at 13 (1974); 132 Cong. Rec.
S6287, May 21, 1986, statement of Sen. Durenberger.)
When considering costs to control contaminants, EPA analyzes
whether the technology is reasonably affordable by regional and large
metropolitan PWSs (See H.R. Rep. No. 93-1185 at 18 (1974) and 132 Cong.
Rec. S6287 (May 21, 1986) (statement of Sen. Durenberger)). EPA also
evaluates the total national compliance costs, considering the number
of systems that will have to install treatment in order to comply with
the MCL. The resulting total national costs vary depending upon the
concentration level chosen as the MCL. The more stringent the MCL, the
greater the number of systems that may have to install BAT to achieve
compliance and the higher the national cost.
The feasibility of setting the MCL at a precise level is also
influenced by laboratory ability to measure the contaminant reliably.
Because compliance with the MCL is determined by analysis with approved
analytical techniques, the ability to analyze consistently and
accurately for a contaminant at the MCL is important for enforcing a
regulatory standard. Thus, the feasibility of meeting a particular
level is affected by the ability of analytical methods to determine
with sufficient precision and accuracy whether such a level is actually
being achieved.
2. Treatment Technologies and Costs
In the July 25, 1990 proposal, EPA identified two technologies as
BATs under Section 1412 of the SDWA for sulfate: Reverse osmosis (RO)
and ion exchange (IE). EPA believes that the costs of these
technologies to large systems are reasonable, and that these
technologies are compatible with other water treatment processes in
different regions of the U.S. These technologies and the costs of using
them are described as follows:
Reverse Osmosis. RO uses semi-permeable membranes to remove a high
percentage of almost all inorganic ions. The technology is relatively
insensitive to flow and total dissolved solids (TDS). The effectiveness
of RO is adversely affected by the presence of turbidity, iron,
manganese, silica, or scale-producing constituents in the source water.
If pretreatment is not already in place to remove these constituents,
additional costs may be incurred to install other technologies (e.g.,
pH adjustment, filtration, or scale-prevention additives). The cost
generated by the model includes the cost of a scale inhibitor. On the
other hand, in situations where high dissolved solids and/or several
contaminants may have to be removed simultaneously, the RO process may
offer an especially desirable and cost-effective approach to their
removal. Less chlorine may be needed due to removal of many bacteria
and viruses during the RO process.
Disadvantages to RO include fouling of membranes either from
scaling or from water with high organic content and a reject stream of
20% to 50% of the water flow. It is also possible that corrosion
control chemicals will be needed after RO, and a more qualified
operator may be needed.
Full scale tests indicate that RO is capable of removing between 86
and 97 percent of the sulfate, and is effectively used for the
reduction of contaminants other than sulfate. Estimated cost for
reducing sulfate by RO range from $3.50/1,000 gallons for systems
serving between 500 and 1,000 persons to $1.00/1,000 gallons for
systems serving more than 1,000,000 persons. High sulfate levels are
typically associated with high levels of TDS, which can indicate the
presence of other inorganics; in such cases, RO becomes a cost
effective treatment technology because it removes those other
inorganics as well. Since the removal efficiency required for sulfate
will typically be less than 86 percent, a portion of the water can be
treated and blended with an untreated portion to reduce the cost of
this process.
Commenters to the Phase V proposed rule expressed concerns
regarding the potential costs associated with disposal of wastes
generated by treatment processes such as RO, particularly in water-
scarce regions. The Agency believes that wastewater would be minimized,
since only a portion of source water containing elevated sulfate levels
would need to be treated, and would then be blended with source water.
With an MCL of 500 mg/L, EPA believes blending treated water and source
water would greatly reduce the reject stream.
Ion Exchange. IE reduces sulfate concentrations to levels below the
MCLG of 500 mg/L at reasonable costs to large systems. Typical sulfate
anion removals using IE are greater than 75 percent in full-scale
studies that evaluated influent concentrations close to drinking water
levels. Estimated costs for IE to reduce sulfate concentrations range
from $2.90/1,000 gallons for systems serving between 500 and 1,000
persons to $1.40/1,000 gallons for systems serving more than 1,000,000
people. When the removal efficiency required for sulfate is less than
75 percent, a portion of the water can be treated and blended with an
untreated portion to reduce cost. For those systems with other anions
that need to be removed (such as nitrate), the removal efficiency will
decrease for those anions since sulfate binds more strongly to the
exchange resin than other anions. A disadvantage of IE is that it may
not be feasible at high levels of TDS.
EPA received a number of public comments on the proposal to select
RO and IE as BATs for the Phase V inorganic contaminants in general and
for sulfate in particular. EPA's responses are in the comment-response
document for the Phase V rulemaking and in the preamble to the final
rule (57 FR 31809-12). In the preamble, EPA responded to comments on
sulfate in particular concerning the disposal of wash brines from IE
and RO treatments in water-scarce areas and on the costs of using RO
and IE to treat for sulfate. EPA is not aware of any new information on
these two technologies or costs since the proposal. Interested parties
are invited to submit any new public comments or new information on the
selection of RO and IE as BAT for sulfate.
Electrodialysis. Since the Phase V proposal, EPA has identified
electrodialysis (ED) as an additional proposed BAT. EPA requests
comment on its conclusion that electrodialysis should also be
considered BAT for sulfate.
ED was the first membrane process developed for desalting brackish
waters, and was commercially available in the 1950's. In the early
1970's, a major technological improvement was made, called
electrodialysis reversal. Recovery ratios increased from the 50% to 60%
range to 80% to 90% recovery.
In ED, feed water containing dissolved ions is pumped across
electrified membranes. The positive ions migrate to the negative
electrode, and the negative ions migrate to the positive electrode, and
are effectively trapped in alternating compartments. The partially
deionized/dilute stream is circulated through additional stages until
the desired purity is obtained. Since this is a unidirectional process,
membrane fouling and mineral scale formation tend to degrade system
performance. Some pretreatment may be required, such as clarification,
presoftening, or treatment with acid or anti-scaling agents.
Electrodialysis reversal (EDR) is the same process but with the
polarity of the current automatically reversed at regular 15 to 30-
minute intervals. This changes the direction of ion movement within the
membrane stack. As a result, foulants and scale tend to be removed from
the membrane surfaces and carried away during the purge period. EDR
requires minimum pretreatment and is very tolerant of system upsets,
shock chlorination, and long-term operation at temperatures up to 45 C.
Sulfate removal of 84% was achieved in a 1990 pilot study in Virginia,
in which efficiency and costs for RO and EDR were compared (AWWA,
1991).
Operating costs for EDR are comparable to those for RO. All
reference to ED as BAT for sulfate removal in this notice will refer to
electrodialysis reversal, rather than unidirectional electrodialysis.
Table 3 summarizes the efficiency and cost of the treatment
technologies proposed as BATs for sulfate, and indicates that each can
reduce the contaminant level from the maximum expected occurrence level
to below the proposed MCLG. The costs in Table 3 are representative of
annual operation and maintenance (O & M) costs plus annualized capital
costs, and may differ depending on local conditions. Costs may be lower
if sulfate concentration levels encountered in the raw water are lower
than those used for the calculations, or higher if additional system-
specific treatment or storage requirements are needed. The general
assumptions used to develop the treatment costs include: Capital costs
amortized over 20 years at a 7 percent interest rate; engineering fees;
contractor overhead and profit; late 1991 power, fuel, labor and
chemical costs. The removal efficiencies cited in Table 3 are what is
possible, and are not directly linked with the cited costs. These costs
are linked with the efficiency needed to achieve the sulfate MCL.
Table 3. Annual Costs of Proposed 1412 BAT for Sulfate (1991 Dollars)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Cost per 1,000
BAT Percent gallons500-1000 Cost per 1,000 gallons3,300- Cost per 1,000
removal population 10,000population gallons1,000,000population
--------------------------------------------------------------------------------------------------------------------------------------------------------
Reverse osmosis.............................................. 86-97 $3.50 $2.20 $1.00
Ion Exchange................................................. >75 2.90 1.90 1.40
Electrodialysis.............................................. 80-90 3.50 2.20 1.00
--------------------------------------------------------------------------------------------------------------------------------------------------------
3. Sulfate Analytical Methods
a. Choice of analytical method. The reliability of analytical
methods used for compliance monitoring is critical at the MCL. EPA
evaluated the availability, costs and the performance of analytical
methods for measuring sulfate, and considered the ability of
laboratories to measure consistently and accurately for sulfate at the
level of the proposed MCL.
In selecting analytical methods, EPA considers five factors:
(a) Reliability (i.e., precision/accuracy) of the analytical
results;
(b) Specificity in the presence of interferences;
(c) Availability of enough equipment and trained personnel to
implement a national monitoring program;
(d) Simplicity of analysis to permit routine use; and
(e) Cost of analysis to water supply systems.
Sulfate has an SMCL of 250 mg/L for which EPA recommends
measurements be made with an EPA method or a Standard Method (SM)
method (40 CFR 143.4(b)), each of which uses a turbidimetric analytical
technique. The July 1990 proposal listed analytical methods for sulfate
that use one of four analytical techniques: turbidimetry, colorimetry,
ion chromatography, and gravimetry. The July 1992 regulations did not
regulate sulfate, but specified a colorimetric analytical technique to
measure sulfate as an unregulated contaminant (40 CFR 141.409(n)(12)).
However, the regulations did not list specific colorimetric methods. In
an analytical methods proposal (58 FR 60622, December 15, 1993) EPA
removed this ambiguity by identifying several colorimetric methods. The
December 1993 proposal also proposed methods that use other analytical
techniques, and improved laboratory efficiency by allowing all sulfate
methods to be used for both secondary and unregulated contaminant
monitoring.
Today EPA is proposing methods that use colorimetric, gravimetric
or ion chromatographic analytical techniques. The methods are proposed
for analysis of sulfate as regulated and as a secondary contaminant.
For information on the precision and accuracy of these methods, EPA
refers readers to the references in Table 4.
Table 4.--Proposed Analytical Methods for Sulfate
----------------------------------------------------------------------------------------------------------------
Contaminant Method EPA (1) ASTM (2) SM (3)
----------------------------------------------------------------------------------------------------------------
Sulfate..................... Colorimetry................ 375.2 ............... 4500-SO4-F.
Gravimetry................. ........... ............... 4500-SO4-C,D.
Ion chromatography......... 300.0 4327-91........ 4110
----------------------------------------------------------------------------------------------------------------
(1) ``Methods for the Determination of Inorganic Substances in Environmental Samples'', EPA/600/R/93/100. NTIS,
U.S. Department of Commerce, 5285 Port Royal Road, Springfield, VA 22161, PB 94-121811, August 1993.
(2) Annual Book of ASTM Standards, Vol. 11.01, 1993, American Society for Testing and Materials, 1916 Race
Street, Philadelphia, PA 19103.
(3) 18th edition of Standard Methods for the Examination of Water and Wastewater, American Public Health
Association, American Water Works Association, Water Environment Federation, 1992.
EPA is not proposing turbidimetric methods because the methods are
inadequate. The operating range of turbidimetric methods is 0 to 40 mg/
L, which requires excessive dilution of the sample to cover the range
between the SMCL (250 mg/L) and the proposed MCL (500 mg/L). EPA
recommends that compliance samples not be diluted more than four or
five-fold to obtain reliable and reproducible results. The gravimetric
and colorimetric chromatographic methods require acceptable dilution of
the sample to measure samples containing more than 350 mg/L of sulfate.
Colorimetric and gravimetric methods have been used for many years
to measure sulfate in water, and were described in the July 1990
proposal. As stated in the July 1992 rule, EPA agrees with comments
that only methylthymol blue, not chloranilate, colorimetric methods are
suitable for sulfate analysis. Therefore, EPA is only proposing
methylthymol blue colorimetric methods for sulfate analysis.
Ion chromatographic methods have been approved for measurement of
nitrate and nitrite (40 CFR 141.23) in drinking water. These methods
have been described or discussed in the July 1990 and the December 1993
proposals, and in 54 FR 22097 (May 22, 1989). EPA is proposing ion
chromatographic methods for sulfate analysis only with the suppressed
column option. EPA has no data to support use of a ``non-suppressed''
column (57 FR 31800), and the Agency is not proposing to approve this
option in any ion chromatographic method.
EPA believes the proposed analytical methods are technologically
and economically feasible for sulfate monitoring. The analytical cost
for sulfate is $10 to $30 per sample. EPA believes these costs are
affordable. Actual analytical costs may vary with the laboratory,
analytical technique selected, the total number of samples and other
factors. The number of laboratories that routinely participate in EPA's
Water Supply and Water Pollution performance evaluation studies
indicates that many laboratories have the capability to conduct
analysis for sulfate.
Sulfate has a long history as a water quality parameter. There is a
large body of performance data available for water pollution studies.
The proposed analytical methods have detection limits much lower than
the proposed MCLG for sulfate. The detection limit for a given
contaminant varies with the analytical method (Table 5).
b. Method detection limits and practical quantitation levels. EPA
determines practical quantitation levels (PQLs) for each substance for
the purpose of integrating analytical chemistry data into regulation
development. The PQL yields a limit on measurement and identifies
specific precision and accuracy requirements which EPA uses to develop
regulatory requirements. As such, PQLs are a regulatory device rather
than a standard that labs must specifically demonstrate they can meet.
The PQLs for inorganic compounds are determined based on the method
detection limits (MDLs) and the results from performance evaluation
data.
Table 5.--Proposed Methodology and Detection Limits for Sulfate
------------------------------------------------------------------------
Detection
Contaminant Method limit (mg/
L)
------------------------------------------------------------------------
Sulfate..... Colorimetry.................................. 3
Gravimetry................................... 1
Ion chromatography........................... 0.02
------------------------------------------------------------------------
The PQL for sulfate was determined using the MCL as well as EPA and
State laboratory data from Water Pollution PE studies using the
procedure described in 54 FR 22100 (May 22, 1989). A PQL of 10 mg/L was
proposed for sulfate in the Phase V proposed rule (55 FR 30411, July
25, 1990). Since the detection limit using the colorimetric method is 3
mg/L, EPA is soliciting comment on whether a higher PQL of 30 mg/L
should be set in order to retain the colorimetric method.
c. Sulfate sample preservation, container and holding times.
Requirements for sample preservation, containers and holding times
listed in Table 6 were proposed for sulfate in the 1990 proposal. No
comments were received on these specifications. The Agency is
reproposing these requirements today.
Table 6.--Sulfate Sample Preservation Container, and Holding Time
Requirements
------------------------------------------------------------------------
Maximum
Contaminant Preservative Container\1\ holding
time\2\
------------------------------------------------------------------------
Sulfate........... Cool, 4 deg.C... Plastic or glass. 28 days.
------------------------------------------------------------------------
\1\Container may be a hard or soft, plastic or glass material.
\2\Samples should always be analyzed as soon after collection as
possible.
d. Laboratory certification. Today EPA is proposing that only
certified laboratories be allowed to analyze samples for compliance
with the proposed MCL for sulfate. EPA recognizes that the
effectiveness of today's proposed regulations depends on the ability of
laboratories to reliably analyze contaminants at low levels. EPA has a
drinking water laboratory certification program that States must adopt
as a part of primacy. (40 CFR 142.10(b)) EPA's Manual for the
Certification of Laboratories Analyzing Drinking Water, EPA/570/9-90/
008, April, 1990, specifies minimum criteria which States must use to
implement their drinking water laboratory certification program.
Performance evaluation (PE) samples are an important tool in EPA's
laboratory certification program. The samples are provided by EPA or
the States to laboratories seeking certification. To obtain and
maintain certification a laboratory must use an approved method, and at
least once a year successfully analyze an appropriate PE sample.
Successful analysis requires that a laboratory report a concentration
of sulfate in the PE-sample that is within the acceptance limits.
Specification of these proposed limits, which are listed in drinking
water regulations at Sec. 141.23(k), is discussed below.
e. Setting PE sample acceptance limits for sulfate. Acceptable
performance has historically been set by EPA using two different
approaches: (1) Regressions from performance of preselected
laboratories (using 95 percent confidence limits), or (2) specified
accuracy requirements. Acceptance limits based on specified accuracy
requirements are developed from existing PE study data. When there are
insufficient PE data to determine expected laboratory performance, EPA
determines acceptance limits from individual study statistics based
upon 95 percent confidence limits. After sufficient performance data
are generated from PE studies, EPA will develop fixed acceptance limits
using a ``plus or minus of the true value approach.'' The true value
approach requires each laboratory to demonstrate its ability to perform
within pre-defined limits. Laboratory performance is evaluated using a
constant yardstick independent of performance achieved by other
laboratories participating in the same study. A fixed criterion based
on a percent error around the ``true'' value reflects the experience
obtained from numerous laboratories and includes relationships of the
accuracy and precision of the measurement to the concentration of the
analyte. It also assumes little or no bias in the analytical methods
that may result in average reporting values different from the
reference ``true'' value. This concept assures that reported results
can be related to the percentage variance from the PQL.
Performance data are available for sulfate at concentrations
proposed for regulation. The data are sufficient to set fixed
acceptance limits of 15% for sulfate PE samples. The
acceptance limits are estimated using the approach described in 54 FR
22132.
4. Establishment of a NPDWR
a. Today's Proposed MCL. Today EPA is proposing an MCL for sulfate
of 500 mg/L, which is equal to the proposed MCLG. EPA believes that
costs for large systems are reasonable and affordable, and that it is
technologically feasible for PWSs to achieve this level for sulfate.
EPA also believes that the flexibility afforded by Option 1 allows
small systems to comply with the MCL in a way that is reasonable and
affordable.
Examination of the BATs identified above (RO, IE, and ED) indicates
that each can reduce the levels of sulfate from the maximum expected
occurrence levels to levels below the proposed MCLG of 500 mg/L
(minimum removal efficiencies of 86%, 75%, and 80%, respectively). The
maximum reported occurrence level for sulfate in a national study (RWS)
is 1,000 mg/L, although individual State data have shown levels twice
as high. Each of these technologies is currently available, has been
installed in PWSs, is compatible with other water treatment processes,
and can remove sulfate from the maximum occurrence level to below the
proposed MCLG. EPA is proposing an MCL for sulfate based upon an
analysis of several factors, including:
(1) The effectiveness of BAT in reducing sulfate levels from
influent concentrations to the MCLG.
(2) The feasibility (including costs) of applying BAT. EPA
considered the availability of the technology and the costs of
installation and operation for large systems.
(3) The performance of available analytical methods.
b. Lead option for implementing the MCL requirement. As described
in the Regulatory Background section, EPA determined that sulfate is
found primarily in small PWSs in the western part of the U.S., and that
compliance with the sulfate MCL would place a significant burden on
these systems. EPA decided that a requirement for PWSs to comply with
the sulfate MCL by treating all of their source water might be
excessive since high sulfate levels affect only persons who are not
acclimated to the water. Therefore, the Agency decided in 1992 to defer
the regulation for sulfate in order to consider ways of allowing PWSs
to comply with the MCL that would not require central treatment.
To develop alternative options for complying with the MCL, EPA held
a meeting with interested States and the Association of State Drinking
Water Administrators (ASDWA). In November 1992, officials from Texas,
South Dakota, Colorado, and New Mexico, ASDWA staff, EPA Regional
staff, and EPA Headquarters staff met to explore regulatory options for
sulfate. They discussed the regulatory process, a toxicological profile
of sulfate, and State perspectives on sulfate regulation, health
effects and implementation options. Neither the issue of whether or not
to regulate sulfate nor the MCL/MCLG levels were topics of discussion.
The participants felt that the sulfate regulation should give the
States flexibility. After the discussions at this meeting, most of the
States present supported the conclusion that PWSs should be allowed to
protect their customers from the risk of sulfate levels exceeding the
MCL either by centralized treatment or through public education/
notification and provision of Alternative Water. The outline of a
regulatory option that included all of these elements was formulated.
Each of the components was directed at a certain population and the
majority agreed that those components, together, would be adequately
protective. The option developed at that meeting is essentially Option
1, being proposed today. In the past, EPA has not generally set
restrictions or conditions on the means of compliance with the MCL.
Traditionally, EPA simply identifies the central treatment technologies
that are considered BAT and then sets the MCL based on the capabilities
of those technologies to remove the contaminant. PWSs are not required
to use the identified BATs but must achieve compliance with the MCL.
EPA regulations prohibit PWSs from using bottled water or POU devices
to achieve compliance with the MCL. In addition, the regulations
prohibit PWSs from using POE devices to achieve compliance with the MCL
unless the PWS meets certain conditions for ensuring effective
protection of all consumers. See 40 CFR 141.100 and 141.101. In Option
1, EPA proposes to override the general prohibition on the use of
bottled water and POU/POE devices and to allow States to authorize PWSs
to use these methods to achieve compliance with the MCL.
c. Method of compliance. The State would have the authority under
Option 1 to allow PWSs to achieve compliance with the sulfate MCL by
one of two methods. The PWS could comply either by using conventional
central treatment or by providing Alternative Water. With the State's
authorization, PWSs would have the choice of supplying bottled water
which complies with EPA MCLs, POU or POE devices to target populations.
Under Option 1, PWSs that provide Alternative Water would also need to
meet certain public education/notification requirements. Transient
systems would also have to provide Alternative Water, but their public
notification requirement would be posting of signs, unless POE/POU
devices brought all taps into compliance. This approach directly
focuses protection on the sensitive populations: Infants, travelers and
new residents. Under Option 1, any program developed by a PWS would
need to contain the following provisions or others which it can
demonstrate are at least as stringent and protective:
(1) Community Water Systems
(i) Bottled water.
PWSs would need to provide and deliver two liters of bottled water
per person per day (unless the customer requests less), on request, to
households with infants, new residents, or transients (visitors). The
bottled water would have to have been monitored or certified to be in
compliance with all EPA MCLs. PWSs would be allowed to deliver enough
water for several weeks, or the entire time period, at once, and would
not be required to provide daily delivery. Infants, up to one year old,
would receive bottled water for a maximum of 20 weeks from the date of
request. Since a mother may nurse her infant during the first year, it
would be her decision as to when to begin giving the infant tap water.
Each new resident (person moving to the high-sulfate community from
another location) would receive bottled water for a maximum of six
weeks. New residents with infants up to one year old would receive
bottled water for their infant for 20 weeks. New residents with infants
older than one year would receive bottled water for themselves and
their infant for six weeks. Since new residents would be informed about
the Alternative Water by the PWS at the time of starting water service
to their residence, the six weeks would begin at that time. Travelers
(guests visiting residents and hotel guests) would receive bottled
water for the period requested, not to exceed six weeks. In resident
households with infants, the public water system would only need to
supply bottled water for the infant in the household. EPA is not
proposing to require that bottled water be provided to resident
pregnant women prior to childbirth, since there seems to be no transfer
of sulfate through the placenta.
The rule would require PWSs supplying Alternative Water to
determine an equitable way of recouping their expenses in providing
that service without charging a premium to the recipients of the
Alternative Water. EPA believes that an additional charge for
Alternative Water (above and beyond what would normally be charged for
the water if it had been delivered through the distribution system)
would be a disincentive to a consumer's decision to request Alternative
Water and receive protection from high levels of sulfate. Therefore,
the proposed rule would prohibit PWSs from charging a premium. The
Agency believes this is necessary in order to ``assure a supply of
drinking water which dependably complies with'' the sulfate MCL (see
SDWA Section 1401(1)(D)). Each utility would need to determine the best
way to meet its operating expenses without imposing a premium on the
subpopulation of customers that is receiving Alternative Water under
the sulfate rule. For example, a PWS could charge the same unit cost
for each liter of bottled water as it charges for centrally-distributed
water. The number of liters of bottled water delivered to a household
would simply be added to the number of liters of centrally-distributed
water that appears on the meter, and the same unit cost would apply to
the entire volume. EPA requests comment on whether it is appropriate to
restrict the PWS's fee structure in this way. In particular, the Agency
is interested in whether there are State or local ratemaking laws or
other laws that bear on this issue.
Two liters per day is the amount of water selected to be provided
since that is the consumption level used by EPA in calculating risk
estimates, and is the 85th percentile consumption level of water for
the U.S. population. Infants are considered to consume one liter per
day, but since they comprise a small portion of the target population,
two liters per day for all members of the target population is retained
for simplicity of implementation. Twenty weeks was chosen as the period
for providing bottled water to infants since EPA staff scientists
believe that this is a sufficiently lengthy period for infants to
become gradually acclimated to high sulfate-containing water.
Similarly, six weeks was chosen as the period for providing bottled
water to new residents and travelers (guests) to allow gradual
acclimation. Although two weeks is the period necessary to acclimate to
high sulfate levels if a person is exposed continually to high-sulfate
water, this rapid time frame would require the person to experience the
adverse effect. In addition, new residents and travelers are likely to
have many activities occupying their attention which may prevent them
from accomplishing the acclimation in a shorter time period. EPA is
requesting comment on these allotted time periods.
The notice provided to customers by the PWS would advise that
during the period when bottled water is provided, there should be
mixing of bottled water with tap water to allow gradual acclimation of
the digestive system to the high-sulfate water. If gradual introduction
of tap water is not done, there could still be adverse health effects
when use of bottled water ceases.
The PWS would be responsible for providing bottled water which
complies with EPA MCLs on request to any household which has an infant
or travelers (guests), and to any household with new residents who have
moved to the community from outside the service area.
Monitoring requirements to ensure that the bottled water meets the
sulfate MCL and other MCLs are explained in the section below on
Compliance Monitoring Requirements.
PWSs would need to maintain a record of public requests for bottled
water, either by a telephone log or other means, by which the date of
the request and the date of delivery are recorded and maintained for
State verification.
If the public notification is done effectively, it is not
anticipated that emergency delivery of bottled water will be necessary.
Customers should have the time to notify the PWS well in advance of the
desired delivery date. In the event that a customer has not had access
to the public notification and is unable to procure bottled water prior
to the normal delivery by the PWS, the PWS should have the ability to
provide an emergency delivery within 24 hours of receiving the request.
(ii) Public Education/Notification.
Public education and public notification are important in making
people aware of the potential adverse health effects of high levels of
sulfate and educating them about how to protect themselves if they are
within the targeted population. For CWSs, there are four components to
the proposed public education and public notification requirement:
Notices in bills, pamphlets, signs and notices to the media. In
communities where a significant portion of the population speaks a
language other than English, the text would need to be in the
appropriate language(s), in addition to English.
Notices in Bills. PWSs would be required to use their bill notices
to inform residents of the sulfate content in their water and its
potential impact on non-acclimated persons. The compliance requirements
for mail delivery would be the same as those for the general public
notification mail delivery requirements in Sec. 141.32(a) (2) and (3),
except that the interval for sulfate notification is proposed to be
every six months rather than three months. EPA is proposing to specify
a six-month interval to assure that a pregnant woman would receive at
least one notice during the term of her pregnancy. The notice would
have to be typed in bold lettering on the bill itself. There would also
need to be an additional page with more information on the potential
health effect from ingesting high levels of sulfate in drinking water.
That page would include information about how expectant mothers and
residents can request and receive bottled water for infants and guests,
how to mix tap water with bottled water over time to gradually
acclimate the person to sulfate, as well as a section reassuring the
consumer that there are no ill effects from high sulfate-containing
water for residents.
The PWS would also need to provide the same notice to new customers
or billing units prior to or at the time service begins.
Pamphlets. PWSs would be required to provide pamphlets to all
medical facilities, which includes, but is not limited to city, county
and State health departments, pharmacies, public and private hospitals
and clinics, family planning clinics and local welfare agencies. The
PWS would need to request that the operators of those facilities make
the pamphlets available to pregnant women. The pamphlets would contain
the information listed above for notices in bills.
Signs. PWSs would be required to post permanent, prominent and
visible signs in all public areas where not all taps will have treated
water.
Notices to the Media. PWSs would be required to submit copies of
the notice described above to radio and television stations that
broadcast to the community served by the water system when sulfate in
excess of the MCL has been detected in the water, and once every six
months while the water delivered into the distribution system exceeds
the sulfate MCL. The geographical service area in question would have
to be indicated and clearly defined in the notice.
(2) Transient Systems and Non-Transient, Non-Community Systems
(i) Bottled Water and POU/POE Devices
Transient systems, which comprise most of the affected systems
(1,200 of 1,950), and non-transient, non-community systems would be
required to make either bottled water which complies with EPA MCLs or
water treated with a POU/POE device available for travelers at
establishments in the service area. Where the target population is
affected on a relatively continual basis, PWSs may find it more cost-
effective to provide POU or POE devices. Where the system rarely serves
members of the target population, it might choose to have a supply of
bottled water on hand. Non-transient, non-community water systems, such
as schools, factories and hospitals, might choose to install POEs in
their cafeterias. PWSs would be responsible for maintaining POU/POE
devices to ensure their continuing effectiveness.
(ii) Public Education/Notification
Public notification for transient systems and non-transient, non-
community systems would be posting of signs. Such systems have no
customers to ``bill'', and notices to the media and pamphlets would not
be effective or necessary. PWSs would be required to post permanent,
prominent and visible signs, made of durable material such as plastic,
in places such as rest areas, campgrounds, gas stations and public
areas. The signs would target travelers and newcomers, and would alert
the public to the health effects of sulfate and the nearest location of
drinking water for individuals not acclimated to high sulfate levels.
The signs would have to be placed in any location where all taps (i.e.,
faucets, fountains, or other source of water that could be used for
drinking) are not providing water in compliance with the sulfate MCL.
If the location has a POE device, posting would not be necessary, since
all taps would provide water that complies with the MCL. In the case of
campgrounds, sources such as hand pumps or trailer hook-ups would be
posted with signs, and bottled water could be available at the entrance
gate or registration area. The Agency recognizes that there are
unmanned, remote campgrounds in the national parks system, and requests
comment on the means of compliance for those systems.
(3) Rationale
The sanctioning of Alternative Water as a means of compliance is an
innovative approach that EPA has developed in recognition of the
special circumstances and concerns surrounding the sulfate regulation.
The proposed option would provide Alternative Water to sensitive
populations only for the period of time needed for acclimation. The
Alternative Water approach is appropriate in this case because the
target populations are readily identifiable and because their need is
short-term. Option 1 provides PWSs flexibility and seeks to alleviate
the financial burden that central treatment might entail for small
PWSs, and as such is in accordance with the objectives of the
Regulatory Flexibility Act.
EPA believes that the requirements of Option 1 for PWSs to provide
bottled water which complies with EPA MCLs or POU/POE devices and to
provide public notice and education, taken together, will assure a
supply of drinking water to the Target Population which dependably
complies with the MCL for sulfate (see SDWA Section 1401(1)(D).
As detailed below in the section on costs, EPA finds that this
Alternative Water approach would result in an annual national cost of
$86 million annually, as compared to an annual cost for central
treatment by all affected systems of $147 million. The $86 million
estimate would be substantially lower except that EPA assumed
conservatively that about 25% of affected systems would choose central
treatment or regionalization even with Option 1 available to them. Of
the $86 million, $7 million would be the cost to the 1,500 systems
choosing the public notification/Alternative Water method of
compliance, and $71 million would be the cost to the 500 systems
choosing central treatment.
To understand how the logistics of the option would work, the
Agency chose two system sizes: A PWS serving a town of 500 people, and
another serving a town of 3,300 people. As very few systems
(approximately 40) serving 3,300 people or more are expected to exceed
the sulfate MCL, this system size was chosen to illustrate that it
would be more cost-effective for a system of that size to centrally
treat. Costs were calculated by using national averages.
In a population of 500, the Agency assumed (based on analysis of
U.S. Census Bureau and Current Population Reports data) that there
would be eight households (500 times 1.68%) with infants and 30
households with new residents (500 times 16.4% divided by 2.6 persons
per household) at any given time. (EPA assumed that an average
household contains 2.6 people. New residents and infants would require
Alternative Water for 6 weeks and 20 weeks, respectively. A system
serving this population of 500 would be required to deliver a maximum
of approximately 8,800 liters of bottled water annually, or 24 liters
per day, as illustrated by the calculations below.
30 households x 2.6 persons x 2 liters x 42 days=6,552 liters
8 infants x 2 liters x 140 days=2,240 liters
Total Annual Bottled Water Needs=8,792 liters
Average Daily Bottled Water Needs 8,792/365 days=24 liters
The above calculation is given as an example only, and the 24-liter
figure is a high estimate. The required mixing of tap water with
bottled water over time for infants and new residents would reduce
their consumption of bottled water. The cost analysis in the RIA for
this rulemaking assumes that bottled water will represent, on average,
half the water consumption for infants and new residents, and that
customers will exercise their option to have less than 2 liters per day
delivered over the entire period.
Although it is up to the water system to decide how to deliver the
water, the Agency finds that the system could contract the delivery
service out to a bottled water supplier or could procure and distribute
bottled water itself. For the sake of simplifying the model, EPA
assumed that a town with a population of 500 would not have to install
any POUs or POEs, and would rely entirely on bottled water for the
target population. The Agency recognizes that, in actuality, some
percentage of such towns may have a restaurant and/or gas station, and
could use a POU/POE device. However, these towns would be few in
number, and the simplified model is retained for costing purposes only.
If such a town had very few travelers passing through, for example, a
restaurant or gas station might find it more cost-effective to use
permanent signs and have bottled water available for those few
travelers. EPA assumes that systems which rarely serve the target
population would comply by posting signs and having bottled water
available for visitors, rather than install POE/POU devices. The Agency
solicits comment on the types of Alternative Water that PWSs would
choose.
For a town with a population of 3300, the logistics become more
complicated. The estimated number of households with infants increases
from 8 to 55. The number of households with new residents becomes 210,
and the number of liters of bottled water to be delivered per day is
approximately 170. It is also estimated that there will be 3 POU units
per town. The Agency thinks that few PWSs serving populations this
large will choose Option 1, and will choose instead to centrally treat.
There are several disadvantages to Option 1. First, it requires
persons to learn about sulfate and take action to protect themselves.
Second, because high-sulfate water is still available at the tap,
Option 1 does not guarantee that all target audiences will be
protected. The Agency requests comment on the feasibility, equity,
enforceability, and attractiveness of the option.
Although EPA believes that allowing compliance with the MCL through
the use of POUs, POEs, and bottled water is acceptable in the case of
sulfate, the Agency continues to believe that it should not be allowed
in the case of other drinking water contaminants, for which the general
prohibitions in 40 CFR 141.100 and 141.101 still would apply. Option 1
proposes to override the prohibition in these sections against using
bottled water and POU devices as a means of compliance with the sulfate
MCL because of its unique characteristics. The susceptible population
is limited, and the health effects are short-lived, so the logistics of
Option 1 are feasible for smaller systems. The effects are immediate,
so the cause/effect relationship of drinking water containing high
levels of sulfate can be easily demonstrated, and the affected
population can be readily convinced of the need for precautions. EPA is
unaware of any other drinking water contaminant having these unique
features. Therefore, EPA considers Alternative Water and public
notification/education to be acceptable means for compliance with the
MCL for sulfate, but not for other contaminants, given current
information on health risk and treatment costs.
Because of the burden of administering Alternative Water in larger
systems, noncompliance and the difficulties of enforcement become
larger concerns. Therefore, EPA considered, but decided against,
limiting the availability of Option 1 to smaller systems (e.g., systems
serving fewer than 3,300 persons). Such a limitation would be unlikely
to have any practical effect since, for cost efficiency reasons,
systems above this size would probably choose central treatment. Also,
EPA's occurrence projections indicate that few if any systems above
3,300 are likely to exceed a sulfate MCL of 500 mg/L.
d. Other options being considered. Option 1 above is EPA's
preferred approach to regulating sulfate in drinking water and is being
proposed by EPA today. EPA believes that Option 1 fully complies with
SDWA's scheme for establishing drinking water regulations and is the
best approach for regulating sulfate. However, there has been
considerable discussion as to the necessity for federal regulatory
action in protecting the public from the real, yet temporary laxative
effect of sulfate. Various commentors on the 1990 proposal argued that
sulfate should not be regulated at all because diarrhea does not
present a significant risk to health, but rather is only an
inconvenience.
The Agency has a statutory requirement to regulate sulfate. In
light of the above comments, EPA is seriously considering the following
additional options for regulating sulfate. EPA solicits public comment
and scientific evidence on all of the options being considered.
Option 2 Under this option, the sulfate MCL and MCLG would be set
at 500 mg/L. However, the target population would be limited to only
infants, that is, only infants would need to be provided drinking water
that meets the MCL for sulfate. The rationale for this option is that
infants are the only population subgroup potentially subject to a
significant risk to health, not due to the initial effect (diarrhea),
but due to their inability to modify their environment or fluid intake,
and the possibility that dehydration could occur if no action is taken.
Under this Option, EPA would be taking the position that the laxative
effect is more of an inconvenience than an adverse health effect in
adults, and that no protection of adults is necessary.
The implementation of Option 2 would require the same public
notification/education activities outlined in Option 1, with
modifications in the text to limit the target population to infants.
The text would state that only infants are exposed to significant risk
from sulfate ingestion. Just as in Option 1, CWSs in excess of the
sulfate MCL would be required to provide notices in bills, signs,
pamphlets and media notices to their customers in the service area.
These CWSs would be required to deliver Alternative Water upon request
to households with infants for a maximum of 20 weeks during their first
year of life. Transient systems and non-transient, non-community
systems would be required to post signs and assure a supply of bottled
water for infants if there is any possibility of an infant being
present at the facility. Since the target population is comprised only
of infants, the allocation of bottled water would be 1 liter per day,
rather than the 2 liters per day proposed under Option 1 for adults and
infants. For costing purposes, the Agency assumes that under Option 2,
no PWS would choose central treatment as a means of compliance. This
assumption is based on the relatively small number of infants (less
than 2% of a given population) and the option's relatively low
administrative and logistical costs. The cost of arranging delivery of
bottled water and providing public notification in the service area
would be lower than the cost of installing central treatment. However,
it is possible that a large PWS, in anticipation of future regulations
for other contaminants, or to comply with other existing regulations
for contaminants that can be removed by the same treatment technologies
as sulfate (e.g., RO), might, in reality, choose central treatment.
Such a system may find the permanent requirement to provide public
notification and bottled water to the target population to be a long-
term administrative burden that is ultimately less cost-effective than
central treatment. A disadvantage to this option is the possible
precedent that would be set by an EPA statement that diarrhea is not
considered an adverse effect for adults.
Option 3 Option 3 differs from Option 2 in the definition of the
targetpopulation. The target population would be composed, as in Option
1, of infants and transient adults (including new residents), all of
whom are subject to the adverse effect. However, unlike Option 1, there
would be two different strategies under Option 3 to protect the two
target population subgroups, infants and adults. As in Option 2,
Alternative Water would have to be provided for infants. Unlike Option
2 however, PWSs would be required to notify transient adults of their
risk, even though not required to provide them with Alternative Water.
Public education/notification requirements would be identical to those
described for Option 1 for both subgroups, except that the text of the
notices would state that Alternative Water is only provided for infants
upon request of the parent. Just as in Option 2, CWSs exceeding the
sulfate MCL would be required to provide notices in bills, signs,
pamphlets and media notices to their customers in the service area, and
deliver bottled water upon request to households with infants for a
maximum of 20 weeks. Similarly, transient and non-transient, non-
community systems would be required to post signs and maintain a supply
of bottled water.
The rationale for Option 3 is that it is necessary to set the MCL
at a protective level, but sufficient for compliance purposes to
provide notification/education to the affected adult population. This
option is based on the theory that adequate protection for adults can
be achieved through proper education and notification. Informed adults
would be able to reduce or avoid the effect by taking the initiative to
purchase bottled water or otherwise abstain from drinking tap water.
Infants, on the other hand, depend on adults for their survival, and
the minimization of diarrhea's effects depends on the adult's gradual
mixing of the infant's tap water with water that complies with the
sulfate MCL. Consequently, more stringent requirements (provision of
Alternative Water) would be imposed to ensure protection of infants.
The disadvantage of this option is that it requires members of the
affected public to protect themselves after being notified of a
potential risk.
e. Implications of Options 1, 2 and 3. Options 1, 2 and 3 represent
a significant change from the Agency's approach in other drinking water
regulations. The principal advantage to these options is the reduced
cost to systems. However, there are potential disadvantages in terms of
policy implications to adopting any of these options which should be
addressed and debated with public participation. EPA recognizes that
there may be concern over the decision not to require PWSs to treat
their water centrally but to allow them to supply water at levels that
may exceed the sulfate MCL, and to rely on the provision of Alternative
Water at the consumer's end to ensure ultimate compliance. A
disadvantage of these three options is that it is possible that some
members of sensitive subpopulations may still drink untreated tap water
from the distribution system and thus, not be protected. Consumers may
be unaware of the need to request Alternative Water, or may find it too
burdensome to do so. While EPA believes that this strategy conforms
with the requirements and intent of the Safe Drinking Water Act, EPA
requests comment on this issue.
Options 1, 2 and 3 also require more assertive action by the public
to ensure protection, especially those served by a CWS. This is true
for Option 1, where adults in the target population would be required
to contact the CWS for Alternative Water, which would then be
delivered. Even more assertive action is needed for Option 3, since
informed adults would have to obtain Alternative Water themselves. For
Options 2 and 3, in transient systems, an adult wishing Alternative
Water might not readily find it, as there would be no requirement to
have it available, except for infants. The Agency is requesting comment
on whether this need for assertive action would be appropriate, or
whether such a strategy is reasonable, given the unique aspects of
sulfate.
Option 2 is based on the premise that diarrhea is not an adverse
effect in adults. Until now, the Agency has considered some effects as
adverse which, by themselves, are not harmful, but are precursors of
adverse effects. Examples are (a) developmental effects, such as an
extra embryonic rib which is later resorbed; (b) benign tumors; (c)
reduction in maternal weight gain, even with no observable fetal
effect; and (d) marginal cholinesterase inhibition. In comparison to
these effects, the long-term effects of sulfate ingestion appear to be
nil, and acclimation occurs in a short period of time. The other
effects mentioned are only detected with scientific measurement, while
diarrhea or loose stools are readily observed by the person ingesting
sulfate. EPA requests comment on whether transient bouts of diarrhea
should be considered an adverse health effect or simply an
inconvenience in adults.
In addition, EPA requests comment on whether, given the available
information, a conclusion can be made that experiencing transient bouts
of diarrhea resulting from ingestion of sulfate in drinking water is
not an adverse effect in any segment of the population (adults or
infants) within the meaning of the Safe Drinking Water Act.
EPA also recognizes that the provisions of this regulation are more
difficult to enforce than central treatment. Indeed, it is for similar
reasons that EPA has always prohibited Alternative Water as a means of
compliance. While PWSs already have the legal option to use a POE
device to comply with any MCL if certain requirements are followed, the
requirements for using bottled water or POU devices have been
applicable only to temporary situations to prevent unreasonable risk to
health. Adoption of any of the proposed options would also mean that
individuals in the target population would drink bottled water on a
temporary basis. However, the extent to which bottled water quality
(i.e., compliance with all MCLs) can be assured varies from State to
State. The Food and Drug Administration (FDA), which is responsible for
overseeing bottled water quality, is continuing to adopt standards
which ensure truthful labeling. However, production and sales of
bottled water have increased dramatically in recent years, and FDA does
not have a complete inventory of domestic bottled water plants. FDA
inspects the known plants, on average, every three to four years, or
more frequently if problems arise (GAO, 1992). A few States have
stricter standards than FDA (NY, CA, PA, CT) and require all bottled
water plants to register with the State and conform to State
requirements.
Similarly, POU devices are not subject to EPA certification. Since
the proposed rule gives the States full authority to decide whether or
not an alternative option would be allowed, each State would presumably
base its decision on the extent to which it believes implementation is
practicable. EPA requests comment on whether it is appropriate to allow
use of bottled water and POU devices for sulfate MCL compliance.
f. Option 4. Because the proposed option (1) and its variations (2)
and (3) represent a significant change in regulatory approach, and in
order to fully consider the issues raised, EPA considered another, more
conventional option. Option 4 was considered in the event EPA
determines that Alternative Water may not be as effective as central
treatment in enabling small systems to comply with the sulfate MCL.
Option 4 would not directly allow the use of Alternative Water as a
means of compliance with the MCL.
In Option 4, systems would need to obtain a variance from the
sulfate MCL under the provisions of SDWA section 1415. As a condition
of receiving a variance, systems would be required to provide
Alternative Water to their target populations, just as in Option 1.
Therefore, the relief under Option 4 would be similar to the relief
under Option 1 but would be provided through a different statutory
mechanism.
In Option 4, central treatment would be designated as section 1412
BAT. Central treatment would be considered economically feasible
despite the financial difficulties presented to small systems, because
the SDWA legislative history indicates Congress' desire that economic
feasibility be determined by reference to large metropolitan water
systems.
Section 1415 (and corresponding State laws) provide that systems
may obtain a variance only after they have applied the designated BAT
technology. However, section 1415 also states that the EPA
Administrator may vary the technologies identified as BAT for purposes
of section 1415 variances ``depending on the number of persons served
by the system or for other physical conditions related to engineering
feasibility and costs of compliance with [MCLs] as considered
appropriate by the Administrator.'' As a key component of Option 4, EPA
would designate Alternative Water along with central treatment as BAT
for purposes of section 1415 variances only. A PWS that is granted a
variance would also be required to meet all of the requirements of
Option 1 for public education/notification and provision of Alternative
Water.
Alternative Water would be designated as a section 1415 BAT because
of the special need to provide bottled water which complies with EPA
MCLs only to targeted populations for a limited time, which represents
a special ``physical condition related to engineering feasibility''
under section 1415. To protect public health from the adverse effects
of sulfate, it is necessary to protect only these specific
subpopulations (infants, travelers, and new residents). It is
technically infeasible to direct treated water only to those households
containing these subpopulations, particularly when various households
contain sensitive subpopulations at different times. However, it is
technically feasible to direct public education and notification and
Alternative Water only to those homes which require it. To treat water
going to households with sensitive subpopulations would require a PWS
to treat all water. The cost of providing treated water to everyone
could be much higher than the PWS would otherwise have to incur.
Option 4 would require administrative involvement by the State in
reviewing variance applications. The additional administrative burden
is a clear disadvantage of this option, especially because many State
agencies administering the drinking water program currently have
significant funding and resource problems. On the other hand, a scheme
based on individually granted variances might be considered more
desirable in that each PWS would need to justify to the State its
individual plan for providing Alternative Water.
States may also choose to grant variances in a block to many PWSs
at a time, thus reducing their own administrative burden. However, the
burden would remain on each system to make an application and present
the details of its program to the State.
For the reasons stated above with respect to Option 1, EPA has
decided not to limit the availability of variances based on Alternative
Water under Option 4 to smaller systems. The public education/
notification requirements discussed under Option 1 would apply to those
systems receiving a variance under Option 4.
Making relief available to small systems only through variances
presents some additional statutory constraints compared to Option 1.
First, variances are only available at the discretion of the State. The
State is free not to grant variances or to issue them under more
stringent conditions than set by EPA. For sulfate, based on the prior
State comments and input, States are seeking flexibility and relief for
small systems and, therefore, might generally be expected not to be
more stringent on variances than EPA. On the other hand, it is unclear
whether States will be dissuaded from providing many variances by the
administrative burdens presented by Option 4.
Second, under section 1415, variances are available only where the
State finds that they will not result in an unreasonable risk to health
(``URTH''). However, EPA does not believe that this constraint will
present any problems since, as a condition of receiving the variance,
PWSs will be required to supply Alternative Water that complies with
the sulfate MCL.
Third, section 1415 requires the State to prescribe with the
variance a schedule for compliance with the MCL. In this case, by
providing Alternative Water to qualify for the variance, the PWS would
in fact be supplying water that meets the MCL. Therefore, EPA believes
it is not necessary or appropriate to prescribe any further schedules
for achieving compliance with the sulfate MCL.
Finally, EPA also notes that SDWA section 1415 provides for
variances where a system cannot meet the MCL because of characteristics
of the raw water source. Here, the raw water source is not the issue;
application of Alternative Water as section 1415 BAT would achieve the
MCL but would be considered not as effective as central treatment in
ensuring a consistent and reliable supply of water at the MCL. EPA
nevertheless believes that Option 4 is consistent with the purposes and
intent of SDWA section 1415, but requests comment on this issue.
As an additional option, EPA considered whether relief to small
systems could be provided through exemptions under SDWA section 1416.
This does not appear to be a viable approach, however. Unlike section
1415, section 1416 does not authorize EPA to vary its designation of
BAT for purposes of exemptions. Instead, to qualify for indefinite
exemptions, section 1415 envisions that small systems will be
continuously working toward obtaining the financing necessary to
install the BAT technologies identified under section 1412 (i.e.,
central treatment). Therefore, exemptions do not appear to be an
appropriate mechanism for providing relief from the sulfate MCL to
small systems. EPA solicits comment on whether exemptions do provide a
mechanism for relief.
g. Additional option. The Agency requests comment on the
feasibility and appropriateness of the Options discussed above. The
Agency is also considering an additional option, namely the traditional
approach of simply relying on central treatment as BAT for all systems,
with no special provisions for relief for small systems. The advantages
to central treatment are that it is the easiest approach to enforce,
and it is consistent with the Agency's regulatory approach for other
contaminants. The disadvantages are that it is costly and would not
provide flexibility or relief for small systems. In particular, under
this option, drinking water that meets the sulfate MCL would need to be
provided to all consumers even though only a small percentage of the
population would experience adverse health effects from ingesting
sulfate. Also, the Agency has concerns that this option would not be
economically feasible for small systems, as discussed in section IV
below. Accordingly, this option is not being offered as the preferred
option in today's notice, but EPA is still considering it, and it has
the potential to be adopted in the final rule. This option would be
adopted, for example, if it appears that the other options would be
inadequate to assure a supply of drinking water that dependably
complies with the sulfate MCL (see Sec. 1401(1)(D) because members of
the target population would fail to take appropriate action to protect
themselves from an acute but temporary adverse health effect. The total
national cost of this option would be identical to that for Option 4
($147 million, see Table 8), since the economic analysis assumed that
all systems would choose central treatment under Option 4. Similarly,
the household cost for this option would be identical to those for
Option 4 (Table 9). The Agency requests comment on whether this option,
which would effectively limit methods of compliance to central
treatment, should be adopted.
5. Compliance Monitoring Requirements
a. Introduction. The proposed compliance monitoring requirements
for sulfate would apply to all systems (community, non-transient non-
community, and transient non-community water systems).
The occurrence of sulfate in drinking water may be predictable
based on several factors including geological conditions, use patterns
(e.g., pesticides), presence of industrial activity in the area, and
type of source or historic record.
PWSs would need to monitor for sulfate in accordance with EPA's
Standard Monitoring Framework (SMF), published Jan. 30, 1991 (56 FR
3564). Monitoring is done for three, three-year compliance periods in a
nine-year cycle. The Phase II regulations established a nine-year cycle
for those contaminants in that Federal Register notice. By agreement
between States and EPA at a Denver work group meeting in 1992,
subsequent rules will begin their individual nine-year cycles in the
first January after the effective date (18 months after promulgation).
The monitoring requirements described in the next section are
proposed to apply to systems which exceed the MCL and are authorized by
the State to select the preferred option (Option 1) to achieve
compliance with the sulfate MCL. For systems which select central
treatment, or which do not exceed the MCL, the SMF is proposed to
apply. If either Option 2 or Option 3 becomes the final regulation for
sulfate and the State allows that method of compliance, the monitoring
requirements described for Option 1 regarding Alternative Water and the
reporting/record keeping requirements for public notification would
apply for systems exceeding the sulfate MCL. Initial monitoring to
determine MCL exceedence would be required of all systems, that is,
community, transient and non-transient, non-community systems.
b. Proposed monitoring requirements for sulfate. The monitoring
requirements for those systems selecting Option 1, with State
authorization, would be as follows, and are consistent with the
provisions of Sec. 142.62 (g) and (h).
(1) Bottled water.
There are regulations in effect (Sec. 142.62) which state that a
PWS can be required or permitted by the State to supply its customers
with bottled water as a condition for receiving a variance or
exemption. These regulations indicate that the State shall require and
approve a monitoring program for bottled water and that the PWS shall
develop and put in place a monitoring program that provides reasonable
assurances that the bottled water meets all MCLs. These same monitoring
requirements are proposed to apply here. The PWS monitors a
representative sample of the bottled water for all contaminants
regulated under Secs. 141.61 (a) and (c) and 141.62 during the first
three-month period that it supplies the bottled water to the public,
and annually thereafter. Results of the monitoring are provided to the
State annually.
The State, in lieu of the above requirements, could accept
certification from the bottled water company that the bottled water
supplied has come from an approved source as defined in 21 CFR
129.3(a); and that the bottled water company has conducted monitoring
in accordance with 21 CFR 129.80(g) (1) through (3); and that the
bottled water does not exceed any EPA MCLs. The PWS would have to
provide certification to the State the first quarter after it supplies
bottled water and annually thereafter. At the State's option a PWS may
satisfy the requirements of this subsection by citing an approved
monitoring program which is already in place in another State.
The existing regulations regarding interim use of bottled water to
avoid an unreasonable risk to health state that the PWS is fully
responsible for the provision of sufficient quantities of bottled water
to every customer via door-to-door delivery. The Option being proposed
today (Option 1) would similarly require door-to-door delivery by the
PWS to persons in the target population when the sulfate MCL is
exceeded. EPA requests comment on whether this door-to-door delivery
requirement is appropriate for the sulfate rulemaking, or whether the
requirements should be more flexible. For example, several possible
means of delivery might be allowed. Distribution points could be
authorized to stock and supply bottled water to the target population,
with coupons issued to consumers in the target population redeemable at
the distribution point. PWSs supplying bottled water to households
would deliver that water upon request and free of charge, except as
discussed under III.B.4.c. above. EPA requests comment on the degree of
flexibility needed in the mechanism for delivery of bottled water that
meets the sulfate MCL.
(2) POU/POE devices.
The existing regulations for variance and exemption conditions
(Sec. 142.62) also describe the requirements for allowing a PWS to use
POU or POE devices. These regulations state that it is the
responsibility of the PWS to operate and maintain the POU and/or POE
treatment system. Before POU or POE devices are installed, the PWS
obtains the primacy agent's approval of a monitoring plan which ensures
that the devices provide health protection to the target population
equivalent to that provided by central treatment. The PWS must apply
effective technology under a State-approved plan. The microbiological
safety of the water must be maintained at all times. The State must
require certification of adequate performance, field testing, and if
not included in the certification process, an engineering design review
of the POU/POE devices. Under Sec. 142.62(h), the design and
application of the POU/POE devices must consider the potential for
increasing concentrations of heterotrophic bacteria in water treated
with activated carbon. The State must be assured that buildings
connected to the system have sufficient POU or POE devices that are
properly installed, maintained, and monitored such that all consumers
will be protected.
The existing regulations described above would be applied in both
Options 1 and 4. EPA assumes that only Options 1 and 4 would entail the
use of POU/POE devices, since in Options 2 and 3, bottled water would
likely be more cost-effective, given the reduced target population. The
Agency seeks comment on whether all of these existing requirements
should be proposed in the case of sulfate MCL exceedence, or whether
more flexible requirements would be appropriate. For example, if
recordkeeping could demonstrate that an effective maintenance program
was in place to ensure the proper functioning of the treatment
equipment and compliance with the MCL, some reduction in monitoring
might be foreseen. The efficiency or longevity of certain types of POU
or POE devices might also be considered.
(3) Effective Dates for Initial Monitoring.
Initial monitoring for all systems would begin in the first January
after the effective date of the rule. EPA's issuance of the final
sulfate rule is scheduled for May 1996. The effective date will be 18
months after the promulgation of the final rule, or November of 1997.
If this schedule is maintained, the initial monitoring for sulfate
would begin in January 1998 for all systems.
(4) Sampling Location.
Under the proposed regulation, both ground water and surface water
systems would take a minimum of one sample at every entry point to the
distribution system which is representative of each well or source
after treatment. The number of samples a system must take will be
determined by the number of entry points. This will make it easier to
pinpoint possible contaminated sources (wells) within a system. In both
surface and ground water systems, the system shall take each sample at
the same sampling point unless conditions make another sampling point
more representative of each source or treatment plant.
(5) Monitoring Frequency.
Surface water systems would be required to monitor annually and
ground water systems would sample every three years. Systems which
comply by Option 1 would not be required to continue monitoring the
water in the distribution system for sulfate. That water may continue
to exceed the sulfate MCL, but the PWS would be in compliance by
providing Alternative Water and public notification to target
populations. However, the water would still have to be monitored for
and meet MCLs for other contaminants.
(6) Public Notice Requirements.
EPA proposes that PWSs who use central treatment and who are
nevertheless not in compliance with the sulfate MCL would be subject to
the public notification requirements in Sec. 141.32. However, the
Agency recognizes that having different public education/notification
requirements for those systems choosing central treatment and those
choosing Option 1 may create confusion, and seeks comment on this
issue.
For PWSs authorized by the State to use whichever option (1 through
4) is promulgated in the final sulfate rule, public notification
requirements are proposed to be those described in section III.B.4.b.3
of this Notice.
c. State Implementation. The Act provides that States may assume
primary implementation and enforcement responsibilities for the PWS
program (primacy). 40 CFR part 142 contains EPA's primacy regulations.
In States or tribal governments where EPA has direct implementation,
resource constraints make it unlikely that the Agency would offer the
alternative options (1 through 4, whichever is promulgated) to systems.
EPA Regional Offices will, however, have the discretion to consider
particular circumstances in their decision about whether or not to
offer and implement the alternative option. The Agency assumes that
most States with primacy would offer the alternative option, but
requests comment on this issue.
Fifty-five out of 57 jurisdictions have applied for and received
primacy under the Act. To implement the federal regulations for
drinking water contaminants, States must have legal authorities which
are at least as stringent as the federal regulations. To update their
programs, States must comply with the requirements in 40 CFR 142.12 on
revising approved primacy programs. This proposal describes the
regulations and other procedures and policies States would need to
adopt or have in place to implement the new regulations for sulfate.
Under this proposal, States would be required to adopt the
following requirements: Modifications to Sec. 141.23, Inorganic
Chemical Sampling and Analytical Requirements, Sec. 141.32, Public
Notification Requirements (i.e., mandatory health effects language to
be included in public notification or violations), and Sec. 141.62(b),
Maximum Contaminant Levels for Inorganic Contaminants, where sulfate
has been added to the list.
In addition to adopting drinking water provisions no less stringent
than the federal regulations listed above, EPA is proposing to allow
States to adopt certain requirements related to this regulation in
order to have their program revision application approved by EPA. This
rule proposes to provide flexibility to the State with regard to
implementation of the monitoring requirements for sulfate depending on
whether a system chooses central treatment or the alternative method of
compliance promulgated in the final rule. In all cases, States would
decide and inform PWSs as to whether the alternative method of
compliance (referred to as Option 1 for simplicity) promulgated in the
final sulfate rule will be allowed. Specifically, States would be
authorized to offer Option 1 as a means of compliance to PWSs who
exceed the sulfate MCL. Under Option 1, the State would need to approve
the monitoring plan of a PWS that chooses the Alternative Water and
public education/notification as a means of compliance. The
requirements would be as follows:
(1) State Primacy Requirements.
To ensure that the State program includes all the elements
necessary for an effective and enforceable program, the State's request
for approval must include a plan that each system monitor for sulfate
by the end of each compliance period. If the State is planning to
authorize PWSs to use Option 1, it would need to submit the text of
State laws requiring the Alternative Water and public notification/
education program, and a description of the State's plan to oversee
compliance of the program. States planning to issue monitoring waivers
would do so according to the requirements of Sec. 142.16.
(2) State Recordkeeping Requirements.
The State shall keep a record of PWSs choosing to use Option 1 to
comply. If the State has authorized Option 1, PWSs would be required to
notify the State within 30 days of reporting a sulfate MCL exceedence,
of its decision on whether to use Option 1 or other means of achieving
compliance.
(3) State Reporting Requirements.
The quarterly report shall include all systems that have violated
the sulfate MCL, and those which the State has authorized to use Option
1.
d. Variances and Exemptions. Option 4 offers relief to small
systems in the form of an alternative to centralized treatment. If a
system in violation of the sulfate MCL chooses centralized treatment
but for some reason cannot achieve compliance, the system would apply
to the Primacy Agent for a variance, and the conditions of the variance
would be the same elements described for Option 1.
(1) Variances
Under section 1415(a)(1)(A) of the SDWA, EPA or a State with
primacy may grant variances from MCLs to those public water systems
that cannot comply with the MCLs because of characteristics of their
water sources. At the time a variance is granted, the State must
prescribe a compliance schedule and may require the system to implement
additional control measures. The SDWA requires that variances may only
be granted to those systems that have installed BAT (as identified by
EPA). However, in limited situations a system may receive a variance if
it demonstrates that the BAT would only achieve a de minimis reduction
in contamination (see Sec. 142.62(d)). Before EPA or a State issues a
variance, it must find that the variance will not result in an
unreasonable risk to health (URTH). In general, the URTH level would
reflect acute and subchronic toxicity for short-term exposures and high
carcinogenic risks for long-term exposures. For sulfate EPA's guidance
regarding what is an URTH level is set at the MCL because sulfate has
an acute adverse health effect. For the sulfate variance, if the PWS
provides public education/notification and Alternative Water, EPA
believes that the State should be able to conclude that the PWS will
not be considered to exceed an URTH because those actions are
considered protective of public health.
Under section 1413(a)(4) of the Act, States with primacy that
choose to issue variances must do so under conditions and in a manner
that is no less stringent than EPA allows under section 1415.
The Act permits EPA to vary the BAT established under section 1415
from that established under section 1412 based on a number of findings
such as system size, physical conditions related to engineering
feasibility, and the cost of compliance. Paragraph 142.62 of this
proposed rule lists the BAT that EPA has specified under section 1415
of the Act for the purposes of issuing variances. The variance BAT is
Alternative Water and public education/notification.
(2) Exemptions
Under section 1416(a), a State or EPA may grant an exemption
extending deadlines for compliance with a treatment technique or MCL if
it finds that:
(a) Due to compelling factors (which may include economic factors),
the PWS is unable to comply with the requirement;
(b) The exemption will not result in an URTH; and
(c) The system was in operation on the effective date of the NPDWR,
or, for a system not in operation on that date, that no reasonable
alternative source of drinking water is available to the new system.
In determining whether to grant an exemption, EPA expects the State
to determine whether the facility could be consolidated with another
system or whether an alternative source could be developed. Another
compelling factor is the affordability of the required treatments. It
is possible that very small systems may not be able to consolidate or
find a low-cost treatment. EPA's analysis of cost for the proposed
sulfate rule shows that, for very small systems, the cost is lower to
provide public education/notification, and Alternative Water than to
provide central treatment. Thus, EPA believes this alternative BAT is
affordable for these systems.
As discussed above, granting exemptions under SDWA section 1416
does not appear to be a viable approach to providing relief from the
sulfate MCL for smaller systems. Unlike section 1415 for variances,
section 1416 does not authorize EPA to vary its designation of BAT for
purposes of exemptions.
IV. Economic Analysis
A. Executive Order 12866
Under Executive Order 12866 (58 FR 51735 (October 4, 1993)), the
Agency must determine whether the regulatory action is ``significant''
and therefore subject to OMB review and the requirements of the
Executive Order. The Order defines ``significant regulatory action'' as
one that is likely to result in a rule that may:
(1) Have an annual effect on the economy of $100 million or more or
adversely affect in a material way the economy, a sector of the
economy, productivity, competition, jobs, the environment, public
health or safety, or State, local, or tribal governments or
communities;
(2) Create a serious inconsistency or otherwise interfere with an
action taken or planned by another agency;
(3) Materially alter the budgetary impact on entitlements, grants,
user fees, or loan programs or the rights and obligations of recipients
thereof; or
(4) Raise novel legal or policy issues arising out of legal
mandates, the President's priorities, or the principles set forth in
the Executive Order.
Pursuant to the terms of Executive Order 12866, it has been
determined that this rule is a ``significant regulatory action''
because it proposes a means of MCL compliance that is unique in its
attempt to limit protection only to the affected populations. As such,
this action was submitted to OMB for review. Changes made in response
to OMB suggestions or recommendations will be documented in the public
record.
EPA prepared a Regulatory Impact Analysis (RIA) for this rule,
titled the Regulatory Impact Analysis of Sulfate (August 30, 1994). The
analysis used the following data, where available, for sulfate:
Occurrence data to determine the number of systems
exceeding the MCL;
Treatment and waste disposal cost data and corresponding
selection probabilities to estimate the system level and aggregate
costs of achieving the proposed MCL; and
Monitoring costs to estimate aggregate costs of the
monitoring requirements.
Occurrence data adequate to determine the number of systems
exceeding the proposed MCL are available for sulfate. Table 7 indicates
the number of systems in several system size categories expected to be
out of compliance with the proposed MCL of 500 mg/L.
Table 7.--Number of Systems Expected to Exceed 500 mg/L Sulfate\1\
------------------------------------------------------------------------
Serving less Serving less
Water system type than 500 than 3300 Total of all
people people systems
------------------------------------------------------------------------
Community Water Systems. 350(356) 500(477) 500(511)
Non-Transient, Non-
Community Systems...... 250(235) 250(264) 250(266)
Transient, Non-Community
Systems................ 1150(1144) 1200(1187) 1200(1189)
Total Number of Systems. 1750(1735) 1950(1929) 1950(1966)
------------------------------------------------------------------------
\1\Numbers are rounded; actual numbers are in parentheses.
B. National Costs of the Proposed Rule
Under Option 1, annualized national treatment and waste disposal
cost is projected to total $86 million for the proposed MCL of 500 mg/
L, of which $8 million is estimated for monitoring and State
implementation.
With State authorization, the 1,500 systems assumed to choose
public notification/education and Alternative Water account for $7
million of the total, or about $5,000 per system. The Agency assumes
that, despite the availability of Option 1, 25% of the systems
(approximately 500) exceeding the sulfate MCL would choose either
central treatment or regionalization, for a total cost of $71 million.
Possible reasons for choosing central treatment would be to avoid a
permanent requirement for public notification/Alternative Water
provision and its associated administrative and logistical costs and
activities, or to comply with other existing or future regulations on
other contaminants. The difference in cost to large systems choosing
central treatment rather than Option 1 is a factor of approximately 3
to 5. EPA assumes that this additional cost would not dissuade large
systems from choosing central treatment. For costing purposes, it was
assumed that all transient systems not choosing central treatment would
install a POE device, and all CWS and NTNC systems not choosing central
treatment would use bottled water or POU devices. In reality, the
Agency recognizes that there would be a mixture of choices among system
types, and that the choice of a POE by a small system constitutes
``central treatment'' for that system, since all water is treated and
the technology used for the POE would be a BAT technology such as RO.
Small transient systems could legally choose a POE device under any of
the proposed options, and since their cost cannot be counted under both
centralized treatment and Option 1, their costs have been included
under the heading ``non-centralized treatment''.
Under Options 2 and 3, the total cost of the rule is approximately
$16 million, which also includes $8 million for State implementation
and monitoring costs. The implementation of Options 2/3 would be much
less costly than Option 1, but would involve all 2,000 systems,
compared to the 1,500 systems which would choose public notification/
education and Alternative Water in Option 1. Consequently, the cost of
implementation would be $8 million rather than the $7 million for
Option 1. The target population would be reduced to infants and the
water allocated reduced to 1 liter per day. Although more infants would
be included by large systems choosing this option, infants comprise
less than 2% of the population at any given time. The difference in
cost to large systems choosing central treatment rather than Options 2/
3 would be at least an order of magnitude. EPA assumes that this
additional cost would dissuade large systems from choosing central
treatment, and therefore that all systems would choose Option 1.
Implementation of Options 2 and 3 would be identical, except for the
content of the public education/notification.
Under Option 4, the total national cost of the rule is $147
million. For costing purposes, it was assumed that all systems would
install central treatment, rather than request a variance. For some of
the smallest systems, the central treatment installed consists of a POE
device, which functions on the same principles as a treatment plant
(e.g., reverse osmosis). Since some percentage of systems would, in
reality, request a variance and comply by public notification/education
and Alternative Water provision, the cost for Option 4 is somewhat of
an overestimate. At the same time the cost for Option 4 is an accurate
estimate of what the cost would be for central treatment for all
affected systems.
Under all options, approximately 2,000 systems, most serving
populations less than 500, are expected to exceed the sulfate MCL.
1. Assumptions Used To Estimate Costs
For each system size category, for both ground and surface water
systems, the projected number of systems with contamination above the
sulfate proposed MCL was determined from the occurrence data. The
number of systems exceeding the MCL was then merged with a compliance
decision matrix, which gave the relative likelihood that a given system
would choose various treatment, compliance and waste disposal options.
For systems choosing central treatment, the resulting estimates
were then multiplied by the unit engineering costs, which include both
capital and O&M costs. Although pre-treatment costs were included in
the estimates, the operation of reverse osmosis by some systems with
very high influent sulfate levels may contribute to the need for
additional post-treatment corrosion control to comply with the lead and
copper rule. This would likely affect only systems with influent
sulfate concentrations above 750 mg/L because more than one-third of
the influent stream would be treated. These costs would be added to the
costs of the BAT, but would not affect EPA's conclusions on
affordability because they would be insignificant compared to the
overall costs of the central treatment technology.
For the purposes of cost estimation, the Agency assumed that the
cost of either POU or POE is the same. Each system is assumed to
install POE, since the cost of one POE is generally less than the cost
of multiple POU units. For example, in a gas station, a POU unit would
be needed at the men's restroom, the women's restroom and the water
fountain in the public area. In this scenario, it might be cost-
effective to install one POE unit versus three POU devices. Several
sources were used to estimate the capital and O&M costs for POU/POE
units, including (1) ``Point-Of-Use Treatment of Drinking Water in San
Ysidro, New Mexico;'' March, 1990; (2) National Network for
Environmental Management Studies Research Report on Affordable Drinking
Water Treatment for PWSs Contaminated by Excess Levels of Natural
Fluoride;'' December, 1991; and (3) ``Very Small Systems Best Available
Technology Document;'' First Draft; September, 1993. The calculations
included some of the following assumptions:
(1) Laboratory costs including four bacteriological analyses and
two sulfate analyses per year.
(2) The replacement frequency for both the particulate filter and
the carbon post filter is assumed to be twice per year.
(3) The purchase price for the POU devices ranges from $329 to $665
depending on the number purchased at one time.
(4) The cost for installation is assumed to be $79.
(5) The cost for a one year maintenance service contract is assumed
to be $508 per unit.
Bottled water costs are based on data provided by the International
Bottled Water Association. The cost includes cost of water, delivery,
and labor. Water is estimated at $1.06 per gallon. People are assumed
to consume 0.53 gallons per day. The Agency estimated 1 delivery per
week with a round trip distance of 25 miles costing $0.28 cents per
mile. The Agency also estimated one hour for each delivery at a labor
rate of $14.70 per hour. For Options 2 and 3, where bottled water is
provided only to infants, the water allocation is one liter per day.
The Agency used Federal Reporting Data System (FRDS) data to
determine how many people lived in an average system in each system
size category. EPA used U.S. Census Bureau population and fertility
data to estimate that 1.68% of the people were infants and 16.4% of the
people were new residents. Recent census data put the average number of
people per household at 2.6. The number of travelers needing
Alternative Water was derived from information from the National Travel
Data Center that there are approximately 1.27 billion person-trips made
nationally each year. The number of traveling persons exposed is
calculated by multiplying the estimated 250 million people served by
all water systems with the probability that a traveler will visit a
system with water containing sulfate levels exceeding the MCL. The
probability that a traveler will visit such a system is calculated by
dividing the resident population in a given system size category by the
total resident population of all systems. This value is then multiplied
by the number of person trips and divided by five (the number of person
trips per year per traveler) to get the population of exposed travelers
in that size category. The resulting estimate is that approximately 1
million travelers are exposed to sulfate in excess of 500 mg/L.
For the public education and notification requirements, the PWS is
responsible for producing and delivering pamphlets according to EPA's
public notification guidelines. The number of pamphlets needed per size
category is calculated based on the population served by the PWS.
Larger population centers will contain more medical facilities. For
example, if size category 1 (25-100 people) serves 0.03% of the total
population, it is also assumed to serve 0.03% of the nation's 6,634
hospitals, 83,425 schools, and so on. The number of permanent signs per
system is calculated by taking the number of hotels, campgrounds,
interstate rest areas, rest rooms in restaurants and gas stations in
the nation and multiplying by the percent of population served by each
size category.
The national annualized cost of the rule for the four options is
shown in Table 8.
Table 8.--National Annual Sulfate Costs for Options 1-4 (Dollars in
Millions)
------------------------------------------------------------------------
Option 1 Options 2/3 Option 4
------------------------------------------------------------------------
Central Treatment............. $71 ............ $139
Public Not./Ed./Alt. Water.... 7 $8 ............
State Implementation.......... 7 7 7
Monitoring.................... 0.5 0.5 0.5
-----------------------------------------
Total................... 86 16 147
------------------------------------------------------------------------
2. Costs to Households
Table 9 illustrates estimated household costs for the options being
considered. For costing purposes, it was assumed that all systems were
community water systems, since transient systems do not have
households. For Option 1, costs increase for systems serving
populations greater than 3,300 due to the fact that most of those
systems would choose central treatment. Costs level off and decrease
for systems serving populations greater than 10,000 due to economies of
scale.
Table 9.--Average Annualized Costs for Households (Dollars In Millions) in Community Water Systems
----------------------------------------------------------------------------------------------------------------
System size No. of systems Option 1 Options 2/3 Option 4
----------------------------------------------------------------------------------------------------------------
25-100.......................................... 1244 $250 $145 $811
101-500......................................... 491 138 56 534
501-3.3K........................................ 194 106 24 376
3.3K-10K........................................ 26 287 4 287
10K-100K........................................ 10 244 2 244
>100K........................................... 0 NA NA NA
----------------------------------------------------------------------------------------------------------------
\1\NA--no systems that size affected by high-sulfate water.
On the basis of these estimated costs, EPA concludes that the
options being considered would be economically feasible, and requests
comment on this conclusion.
3. Assumptions Used to Estimate Benefits
The Agency made assumptions for estimating the benefits of diarrhea
cases avoided which included affected population, costs of medical
care, and value of days lost to care givers, business travelers and
vacationers.
It is estimated that approximately 1.2 million people will have
reduced exposure to sulfates as a result of PWSs' compliance with the
sulfate MCL. The low and high estimates of reduced population exposure,
based on uncertainty in occurrence data, are 0.9 million and 1.7
million people, respectively.
Evaluating benefits is limited to estimating reduced population
exposure because there are inadequate dose-response data to estimate
cases of adverse health effects avoided. Consequently, potential
benefits per case of diarrhea avoided are estimated rather than total
benefits. Exposed population is usually calculated by multiplying the
number of systems failing the MCL by the average population served by
each system. A different approach was used for sulfate, since only
unacclimated persons and infants are affected. The affected population
is in areas served by systems with sulfate levels of 500 mg/L or more,
and includes resident infants under one year of age, travellers,
including infants, of all ages visiting the area, new residents and
houseguests that stay with residents. Infants were assumed to accompany
parents on pleasure trips but not on business trips. Sources of
population data were the National Travel Data Center and the U.S.
Census Bureau Current Population Reports and fertility statistics. The
Agency used the 1991 census data for the number of infants born in a
year. The number of persons exposed is calculated by multiplying the
estimated 250 million people served by all water systems with the
probability that the average traveler will visit a system with elevated
sulfate levels. The Agency used the National Travel Data Center
estimate of approximately 1.27 billion person-trips made nationally
each year for travelers. The number of diarrhea cases avoided is based
on the estimate of person-trips because each un-acclimatized individual
is assumed to face multiple exposures to sulfate and potentially
contract diarrhea more than once a year.
This estimate of people exposed has uncertainty based on two
variables: the number of systems with elevated sulfate levels, and the
data used to model the traveling population. The best estimate of the
number of travellers and resident infants with reduced exposure to
sulfate at an MCL of 500 mg/L is 1.2 million people (including 27,000
infants). A logistic response function was used to characterize the
statistical relationship between sulfate levels in drinking water and
the probability of an exposed individual experiencing a laxative
effect. One weakness of this approach is that it assumes that
consumption of either sodium sulfate or magnesium sulfate results in
equivalent laxative effects. It has been reported that magnesium
sulfate is a better purgative than sodium sulfate.
Uncertainty is also associated with the lack of toxicological data
on the relationship between various sulfate levels and the resulting
laxative effect. There are insufficient data to plot a dose-response
function. As a result, the Agency is limiting its estimate of benefits
to an individual case basis.
The assumptions made in estimating benefits on a case by case basis
are shown in Table 10. The value of an outpatient case in Table 10 is
between $218-$273. For example, the value of a case of diarrhea in a
resident infant who is not hospitalized would be $55+$11 for the doctor
and medication, plus 8 hours of the care giver's time ($19 x 8=$152),
since it is assumed the caretaker would miss work. The total value for
the case is $66+$152=$218. An additional $55 would be added in the case
of a traveling infant for hotel and travel expenses lost. The range
accounts for the difference between residents and travelers. The infant
hospitalization cases cost between $3,608 and $3,828 per case. The
Agency is requesting comment on the assumptions used in the analysis of
the benefits of the proposed rule.
Table 10.--Assumptions Made in Estimating Benefits
----------------------------------------------------------------------------------------------------------------
Resident Travelling Travelling New resident
infants infants adults adults
----------------------------------------------------------------------------------------------------------------
Out-Patient Cases:
Doctor Charges.............................. $55 $55 $55 $55
Medication Charges.......................... $11 $11 $11 $11
Days Lost Per Case.......................... 1 1 1 1
Value of Each Day Lost\1\................... (NA) $55 $55 (NA)
Hours Lost Per Case......................... 8 8 8 8
Value of Each Hour Lost..................... $19 $19 $19 $19
Value Per Case:............................. $218 $273 $273 $218
Hospitalized Cases:\2\
Number of Days.............................. 4 4 0 0
Hospital Cost Per Day....................... $750 $750 0 0
Value of Each Trip Day Lost\3\.............. (NA) $55 0 0
Hours Lost Per Case......................... 32 32 0 0
Value of Each Hour Lost..................... $19 $19 0 0
Value Per Case.............................. $3,608 $3,828 0 0
----------------------------------------------------------------------------------------------------------------
\1\Out of pocket hotel and travel expenses, not applicable to infants or new residents, only to business
travelers.
\2\NA--Older travellers are not hospitalized.
\3\No value assigned to trip days lost for infants.
C. Comparison to Earlier Proposed Rule
The 1990 proposed rule estimated the cost for central treatment to
be $65 million (excluding monitoring costs). There were assumed to be
1350 systems which would need to treat for sulfate. For this reproposal
EPA updated the cost to $139 million (excluding State and monitoring
costs). The increase in cost is due to: (1) The increase in projected
number of systems that would exceed the sulfate MCL from 1350 to 1950,
(2) change in the interest rate from 3% to 7%, and (3) updating for
1991 dollars.
Although the new occurrence information was taken primarily from
the National Inorganics and Radionuclides Survey (NIRS), EPA
complemented that information with sampling data from New York, Utah,
South Dakota, North Dakota and New Jersey. Because of the new
occurrence information, the number of systems has gone up from 1350 to
1950. Another reason for the increase is EPA's modification, as a
result of research for the upcoming regulation concerning the control
of radionuclides in drinking water, of the number of treatment sites
per ground water system. Ground water systems frequently contain more
than one site requiring treatment because wells are typically not piped
to a central source. EPA has incorporated this estimation method for
all systems served by ground water.
D. Annual Burden to PWSS and States
EPA estimates that the cost of sulfate regulation to State programs
will be $7 million per year. Table 11 illustrates the 18-year average
annual national burden hours, responses and costs to PWSs and States.
Sulfate testing does not require special laboratory equipment.
Therefore, it is assumed that laboratory expansion undertaken to
implement the Phase II and Phase V regulations will largely satisfy the
monitoring needs of this rule. On the other hand, EPA recognizes that
States are likely to provide more technical assistance to systems than
for an average contaminant because of the unique nature of Option 1.
Total annual costs are estimated to be $10.6 million. The additional
public reporting burden on PWSs for this collection of information is
estimated to average 8.6 hours per response.
Table 11.--Annual Burden Hours
------------------------------------------------------------------------
PWSs States Total
------------------------------------------------------------------------
Annual Burden (Hours)... 66,581 300,000 366,581
Annual Cost ($)......... $3,577,613 $7,000,000 $10,577,613
Annual Responses........ 42,615 57 42,672
------------------------------------------------------------------------
Source: Sulfate ICR, August 31, 1994.
V. Summary of Selected Issues
EPA is soliciting public comment and scientific information on all
issues presented in or pertaining to this proposed sulfate regulation.
In particular, EPA requests comments on the following:
(1) Is there a correlation between sulfate concentrations,
palatability and consumption of high-sulfate water by the public?
(2) Are there new data in support of or opposing the reproposed
MCLG of 500 mg/L? Are there new data in support of a higher MCLG?
(3) Are there data to support or refute the hypothesis that the
decrease in available water resulting from sulfate ingestion may result
in dehydration in adults or infants?
(4) Are reverse osmosis, ion exchange and electrodialysis reversal
appropriate technologies for sulfate removal?
(5) Should a higher PQL of 30 mg/L be set in order to retain the
colorimetric method of analysis?
(6) Are the allotted time periods for provision of Alternative
Water, i.e., 20 weeks for infants within the first year of life and 6
weeks for new residents and travelers, appropriate and protective?
(7) What should be the means of compliance for unmanned, remote
campgrounds in the national parks system, particularly in regard to the
provision of Alternative Water?
(8) What types of Alternative Water would be likely to be chosen by
public water systems of various types and sizes?
(9) Are the compliance requirements, that is, Alternative Water and
public notification, sufficiently protective of the sensitive
population?
(10) Should the target population be limited just to infants, or
should there be different requirements for protecting infants and
adults?
(11) Are the proposed options consistent with the purposes and
intent of SDWA, and are they feasible?
(12) Is a provision to allow the water supply to exceed the sulfate
MCL while relying on public notification and self-protection
appropriate under SDWA?
(13) Is the need for assertive action on the part of the public for
self-protection appropriate?
(14) Should temporary diarrhea be considered an adverse health
effect in adults or infants?
(15) Would exemptions provide a mechanism for relief to smaller
systems?
(16) Should compliance be limited to central treatment?
(17) Is it appropriate under SDWA to allow the use of bottled water
and POU devices for sulfate MCL compliance?
(18) What degree of flexibility is appropriate in the bottled water
monitoring requirements and delivery mechanism?
(19) In Options 1 and 4, should all the existing regulations
regarding use of POU and POE devices be imposed in the case of sulfate
levels higher than the MCL, or are more flexible requirements
appropriate?
(20) Should the generic public notice requirements applicable to
variances under Sec. 141.32 apply under Option 4 to systems who choose
central treatment, in lieu of the public notice requirements proposed
in Option 1?
(21) Are the assumptions used in the analysis of the costs and
benefits of the proposed rule reasonable?
(22) What flexibility is appropriate or practical in regard to the
maintenance of POU/POE devices installed to comply with the sulfate
MCL? What flexibility is appropriate regarding a reduction in
monitoring if certain types of POU/POE devices were installed?
(23) Would most States offer the alternative option to PWS as a
means of compliance?
VI. Other Requirements
A. Regulatory Flexibility Analysis
The Regulatory Flexibility Act (5 U.S.C. 601 et seq.) calls for the
Agency to consider the potential impacts of proposed regulations on
small businesses, organizations and government jurisdictions. If an
analysis shows that regulations would have a significant impact on a
substantial number (usually taken as at least 20 percent) of small
entities, then a regulatory flexibility analysis (RFA) must be
prepared. In an RFA, an agency examines ``any significant alternatives
to the proposed rule which accomplish the stated objectives of
applicable statutes and which minimize any significant economic impact
of the proposed rule on small entities'' (Regulatory Flexibility Act
section 603).
Today's proposed regulation would affect less than 2,000, or one
percent, of the total of 200,000 public water systems (including all
community and non-community systems). Nevertheless, EPA's analysis
shows that regulating sulfate through standard approaches that assume
the need for central treatment would have significant economic impacts
that would fall largely on smaller public water systems. Therefore, EPA
has conducted a regulatory flexibility analysis by investigating
alternative, less burdensome regulatory approaches for those small
systems. From these investigations, EPA developed and is considering
the innovative options for regulating sulfate described earlier in this
notice. These innovative options accomplish the Regulatory Flexibility
Act's goal of minimizing the impacts of this regulation on small public
water systems while meeting the objectives of the Safe Drinking Water
Act by ensuring that drinking water that meets the sulfate MCL will be
provided to all persons within the target population.
B. Paperwork Reduction Act
The information collection requirements in this proposed rule have
been submitted for approval to the Office of Management and Budget
(OMB) under the Paperwork Reduction Act (44 U.S.C. 3501 et seq.). An
Information Collection Request (ICR) document has been prepared by
EPA(ICR No. 270.34) and a copy may be obtained from Sandy Farmer,
Information Policy Branch; EPA; 401 M Street, SW. (Mail Code 2136);
Washington, DC 20460 or by calling (202) 260-2740.
This collection of information has an estimated annual reporting
and recordkeeping burden averaging 9.3 hours per respondent. These
estimates include time for reviewing instructions, searching existing
data sources, gathering and maintaining the data needed, and completing
and reviewing the collection of information. National annual burden and
cost estimates for PWSs and States are presented in Table 11.
Send comments regarding the burden estimate or any other aspect of
this collection of information, including suggestions for reducing this
burden to Chief, Information Policy Branch; EPA; 401 M Street, SW.
(Mail Code 2136); Washington, DC 20460; and to the Office of
Information and Regulatory Affairs, Office of Management and Budget;
Washington, DC 20503, marked ``Attention: Desk Officer for EPA''. The
final rule will respond to any OMB or public comments on the
information collection requirements contained in this proposal.
C. Enhancing the Intergovernmental Partnership
Executive Order 12875, Enhancing Intergovernmental Partnerships
explicitly requires Federal agencies to consult with State, local, and
tribal entities in the development of rules and policies that will
affect them. EPA has complied with the Order in proposing the sulfate
rule in the following ways.
First, the Agency met with interested parties, including
representatives from four States, Region 8, and the Association of
State Drinking Water Administrators in Denver, Colorado in November,
1992.
Secondly, the Agency plans to meet with the National Drinking Water
Advisory Council (NDWAC), a group composed of representatives from
State, local and tribal governments in addition to water suppliers and
environmentalists.
Thirdly, the Agency is developing generic contacts with State,
Tribal and local fiscal and program officials which will enable various
programs to consult with affected parties in a coordinated fashion.
Identification of appropriate contacts was not accomplished in a time
frame which enabled EPA's Office of Water to have extensive
consultation with affected parties in compliance with the E.O. before
proposal. However, a contact person has now been designated from ASDWA,
and the Agency will be meeting with this designee and other interested
State officials. EPA is committed to expanded dialogue and
collaboration with State, Tribal and local governments. EPA will
schedule a work group or public meeting to solicit comments of fiscal
and program officials or State, Tribal and local governments. The
intent of such a meeting is to allow for the maximum input from the
regulated community for the drafting of the final rule. EPA will also
send copies of this proposed rule to these governmental bodies, as well
as to national and local associations (e.g., the Association of State
Drinking Water Administrators, the National League of Cities, the
National Association of Towns and Townships, the National Association
of County Health Officers, etc.)
VII. References
The following references are referred to in this notice and are
included in the public docket together with other correspondence and
information. The public docket is available as described at the
beginning of this notice. All public comments received on the proposal
are included in the public docket.
American Water Works Association (AWWA) Conference Proceedings (March
1991): Suffolk Introduces Electrodialysis Reversal to Virginia. M.
Thompson and M. Robinson.
Canadian Guidelines. Personal correspondence (August 23, 1991) from R.
Tobin to C. Abernathy, citing Guidelines for Canadian Drinking Water
Quality, 4th Edition (1989).
Chien, L., Robertson, H., Gerard, J.W. 1968. Infantile gastroenteritis
due to water with high sulfate content. Can. Med. Assoc. J. 99:102-104
Federal Register. Vol. 54, No. 97. National Primary and Secondary
Drinking Water Regulations; Proposed Rule (May 22, 1989) 22062-22160.
(54 FR 22062)
Federal Register. Vol. 55, No.143. National Primary and Secondary
Drinking Water Regulations; Synthetic Organic Chemicals and Inorganic
Chemicals; Proposed Rule (July 25, 1990), 30370-30448. (55 FR 30370)
Federal Register. Vol. 57, No. 138. National Primary and Secondary
Drinking Water Regulations; Synthetic Organic Chemicals and Inorganic
Chemicals; Final Rule (July 17, 1992), 31776-31838. (57 FR 31776)
Federal Register. Vol. 58, No. 239. National Primary and Secondary
Drinking Water Regulations; Proposed Rule. (December 15, 1993) (58 FR
60622)
GAO, Food Safety and Quality, Limitations of FDA's Bottled Water Survey
and Options for Better Oversight. GAO/RCED-92-87, February 1992.
Information Collection Request, August 31, 1994
Peterson, N.L. 1951. Sulfates in drinking water. Official Bulletin N.D.
Water Sewage Works 18:11.
Moore, E.W. 1952. Physiological effects of the consumption of saline
drinking water. A progress report to the 16th Meeting of the
Subcommittee on Water Supply of the Committee on Sanitary Engineering
and Environment, January, 1952. Washington, DC: National Academy of
Sciences, Appendix B.
Regulatory Impact Analysis, August 31, 1994
Schild, H.O. Applied Pharmacology 12th Edition (1980) ``The Alimentary
Canal'': 197-198. Churchill Livingstone, Inc.
U.S. EPA Comment/Response Document for Sulfate from Phase V
U.S. EPA Expert Panel Meeting Minutes, May 20, 1992.
U.S. EPA Early Involvement Meeting Minutes, Denver, CO, 1992
U.S. EPA Health Criteria Document for Sulfate, January 1992
U.S. EPA Lab Certification Manual Section
WHO, 1983. World Health Organization. Guidelines for drinking water
quality--recommendations. Volume 1. Geneva, Switzerland: World Health
Organization.
List of Subjects in 40 CFR Parts 141, 142 and 143
Chemicals, Reporting and recordkeeping requirements, Water supply,
Administrative practice and procedure.
Dated: November 30, 1994.
Carol M. Browner,
Administrator.
For the reasons set out in the preamble, 40 CFR parts 141, 142 and
143 are proposed to be amended as follows:
PART 141--NATIONAL PRIMARY DRINKING WATER REGULATIONS
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 and 300j-9.
Sec. 141.23 Inorganic chemical sampling and analytical requirements.
2. Section 141.23 is amended by revising the last sentence of the
introductory text to read as follows:
Transient, non-community water systems shall conduct monitoring to
determine compliance with the nitrate, nitrite and sulfate maximum
contaminant levels in Sec. 141.11 and Sec. 141.62 (as appropriate) in
accordance with this section.
* * * * *
Sec. 141.23 [Amended]
3. In Sec. 141.23(a)(4)(i), the table is amended by adding in
alphabetical order an entry for sulfate to read as follows:
* * * * *
(a) * * *
(4) * * *
(i) * * *
----------------------------------------------------------------------------------------------------------------
Detection
Contaminant MCL (mg/l) Methodology limit (mg/l)
----------------------------------------------------------------------------------------------------------------
* * * * * **
Sulfate................................ 500 Colorimetry............................ 3
Gravimetry............................. 1
Ion Chromatography..................... 0.02
----------------------------------------------------------------------------------------------------------------
* * * * *
Sec. 141.23 [Amended]
4. In Sec. 141.23(c) introductory text, ``sulfate'' is added in
alphabetical order to the list of contaminants.
Sec. 141.23 [Amended]
5. In Sec. 141.23(d) introductory text, ``and sulfate'' is added
after the word ``nitrate''.
Sec. 141.23 [Amended]
6. In Sec. 141.23(f)(1), ``sulfate'' is added in alphabetical order
to the list of contaminants.
Sec. 141.23 [Amended]
7. In Sec. 141.23(i)(1) and Sec. 141.23(i)(2), ``sulfate'' is added
in alphabetical order to the list of contaminants.
Sec. 141.23 [Amended]
8. The table in Sec. 141.23(k)(1) is amended by adding an entry for
``Sulfate'' in alphabetical order as follows:
* * * * *
(k) * * *
(l) * * *
----------------------------------------------------------------------------------------------------------------
Contaminant Methodology EPA1512 ASTM\2\ SM\3\ USGS\4\ Other
----------------------------------------------------------------------------------------------------------------
* * * * * **
Sulfate......... Ion \8\300.0 D4327-91...... 4110 ........... ...........
chromotography.
Colorimetry.... \8\375.2 .............. 4500-SO4-C,D ........... ...........
Gravimetry..... ........... .............. 4500-SO4-F ........... ...........
----------------------------------------------------------------------------------------------------------------
* * * * *
Sec. 141.23 [Amended]
9. In Sec. 141.23(k)(4), ``Sulfate'' is added in alphabetical order
to the list of contaminants, and the table is amended as follows:
* * * * *
(k) * * *
(4) * * *
------------------------------------------------------------------------
Contaminant Preservative\1\ Container\2\ Time\3\
------------------------------------------------------------------------
*****
Sulfate..... Cool, 4 deg.C......... P or G................. 28 days
------------------------------------------------------------------------
* * * * *
Sec. 141.23 [Amended]
10. In Sec. 141.23(k)(5), introductory text, ``sulfate'' is added
in alphabetical order to the list of contaminants.
Sec. 141.23 [Amended]
11. In Sec. 141.23(k)(5)(ii), the table is amended by adding an
entry for sulfate as follows:
(k) * * *
(5) * * *
(ii) * * *
------------------------------------------------------------------------
Contaminant Acceptance limit
------------------------------------------------------------------------
Sulfate............................ 15% at 10
mg/l
------------------------------------------------------------------------
* * * * *
Sec. 141.23 [Amended]
12. Section 141.23 is amended by adding paragraph (r) to read as
follows:
* * * * *
(r)(1) Compliance with the MCL for Sulfate. (i) PWSs subject to the
sulfate MCL established under Sec. 141.62(b) shall demonstrate
compliance with the sulfate MCL. If authorized by the State to do so,
PWSs may choose to comply in one of the following two ways:
(A) The PWS shall demonstrate compliance by achieving the MCL in
samples taken at each entry point to the distribution system; or
(B) The PWS shall demonstrate compliance by meeting the
requirements of Secs. 141.23(r)(2) and (3) (program for providing
Alternative Water to Target Populations and providing public
notification and education). The requirements of Secs. 141.23(r)(2) and
(3), taken together, are termed the ``Alternative Method of
Compliance.'' However, the availability of the Alternative Method of
Compliance is limited by paragraph (r)(1)(ii) of this section.
(ii) The State has the option of whether or not to allow PWSs to
demonstrate compliance through the Alternative Method of Compliance.
Where the State has chosen not to allow the Alternative Method of
Compliance, PWSs shall demonstrate compliance by achieving the MCL in
samples taken at each entry point to the distribution system.
(iii) Where EPA is the primacy agent, the Regional Administrator
may authorize PWSs to demonstrate compliance through the Alternative
Method of Compliance. In determining whether to authorize the use of
the Alternative Method of Compliance, the Regional Administration in
its sole discretion may consider the availability of regional
resources, and whether it is reasonable and practical for the Regional
Office to oversee implementation of the Alternative Method of
Compliance. If the Regional Administrator authorizes the Alternative
Method of Compliance, each PWS shall have the option to comply either
by achieving the MCL in samples taken at each entry point to the
distribution system or through the Alternative Method of Compliance.
(iv) Until such time as notified by the State or Primacy Agency
that the Alternative Method of Compliance will be authorized, PWSs
shall be required to achieve the MCL at each entry point to the
distribution system.
(v) The general prohibition on the use of bottled water and point-
of-use devices in 40 CFR 141.101 shall not apply to PWSs that choose to
achieve compliance with the MCL for sulfate by meeting the requirements
of the Alternative Method of Compliance.
(vi) A PWS must report failure to comply with a NPDWR to the State
under the requirements of 40 CFR 141.31. Within 30 days of notifying
the State of failure to comply with the sulfate MCL, the PWS shall
notify the State as to which of the two methods of compliance,
Sec. 141.23(r)(1)(i) (A) or (B), the PWS intends to use to return to
compliance with the sulfate MCL.
(2) Alternative Water Supplied to Target Populations. The
requirements of this subsection apply only to a PWS that has chosen to
comply with the MCL for sulfate through the Alternative Method of
Compliance instead of by achieving the MCL in samples taken at each
entry point to the distribution system.
(i) Definitions. (A) Alternative water: For purposes of this
section, a PWS supplies Alternative Water when it supplies either
bottled water or water that has been treated with a POU or POE device
(as defined in Sec. 141.2).
(B) Target population, for purposes of this section, means all
infants, travelers and new residents within the PWS's service area,
according to the following:
(1) For the purposes of this rule, infant is defined as persons
under the age of 12 months.
(2) Transients means visitors from outside the service area,
vacation travelers and business travelers.
(3) New residents means persons who have resided in the service
area for no more than six weeks.
(ii) Community water systems shall maintain a record of all
requests for Alternative Water. Records shall include the name and
address of the person requesting the water, date of request, date of
delivery requested, date of delivery and quantity of water delivered
(or date of installation in the case of a POU/POE device). This record
shall be maintained for five years from the time of recording.
(iii) Community water systems shall supply Alternative Water in
compliance with this subsection to the Target Population for the time
periods described under paragraph (r)(2)(vii) of this section.
Transient water systems and non-transient, non-community systems shall
have alternative water available for infants, travelers, newcomers and
visitors.
(iv) Community water systems shall provide door-to-door delivery of
the bottled water or installation of POU or POE devices upon request to
customers who are within the Target Population. The PWS shall have the
option of deciding whether to provide a customer with bottled water or
POU/POE devices.
(v) Bottled water requirements. (A) Quality. Bottled water provided
by the PWS shall meet the requirements of Sec. 142.62 (g)(1) or (g)(2)
of this chapter.
(B) Quantity. Community water systems shall have bottled water
available and delivered at the level of two liters per day for each
person within the Target Population for whom bottled water is requested
(unless the customer requests a lesser amount). Transient water systems
and non-transient, non-community systems shall have sufficient bottled
water to serve the transient population, unless POE or POU devices are
installed.
(C) Time of delivery. Community water systems shall deliver the
bottled water within 24 hours of the request, or on the date requested,
whichever is later.
(vi) POU and POE device requirements. PWSs that choose POU or POE
devices as a method of compliance shall meet the following
requirements:
(A) PWSs that choose POE devices as a method of compliance shall
meet the requirements of Sec. 141.100 (a) through (d).
(B) If the PWS decides to provide a POE/POU device and is unable to
install such equipment within 24 hours of the request, or on the date
requested, the PWS shall provide bottled water to the target population
during the interim time period between the time of the request and the
time of installation of the POU/POE device.
(C) PWSs that choose POU devices as a method of compliance shall
obtain the approval of a monitoring plan which ensures that the devices
provide water that complies with the sulfate MCL. It is the
responsibility of the public water system to operate and maintain the
POU system. The microbiological safety of the water must be maintained
at all times. The State shall require adequate certification of
performance and a rigorous engineering design review. The design and
application of the POU must consider the potential for increasing
concentrations of heterotrophic bacteria in water treated with
activated carbon.
(D) The State must be assured that the POU and POE devices are
properly installed, maintained and monitored.
(vii) Period of delivery. The PWS shall provide Alternative Water
for the following time periods:
(A) Alternative Water shall be provided to each infant for the
period requested, which may not exceed twenty weeks from the date of
initial delivery. Alternative Water delivery shall be provided for the
full twenty weeks if requested, even if the infant becomes one year of
age during the delivery period.
(B) Alternative Water shall be provided to each traveler and new
resident for the period requested, not to exceed six weeks from the
date of initial delivery.
(3) Public Notification/Education Program. The requirements of this
section apply only in States which have authorized the Alternative
Method of Compliance. The requirements apply only to those PWSs in such
States which have chosen to comply with the sulfate MCL through the
Alternative Method of Compliance rather than by achieving the MCL in
samples taken at each entry point to the distribution system. The PWS
shall implement the public notification/education program described in
this subsection in lieu of Sec. 141.32, and shall provide the State
with copies of all public notification and education materials at the
same time. There are four components to the program: Notices in bills,
pamphlets, signs, and notices to the media. Transient systems (e.g.,
campgrounds and gas stations) and non-transient, non-community systems
(e.g. schools, factories) shall be required to post signs in accordance
with paragraphs (r)(3)(v) of this section, but shall not be required to
comply with the requirements for notices in bills, notices to the
media, or pamphlets in paragraphs (r)(3) (i)-(iv) and (vi) of this
section. Community water systems which are non-transient systems shall
comply with all four components set forth in paragraphs (r)(3) (i)-(vi)
of this section, i.e., notices in bills, pamphlets, signs, and notices
to the media.
(i) Newspaper, mail, hand delivery, of notices. PWSs shall give
notice by publication in a daily newspaper of general circulation in
the area served by the system as soon as possible, but in no case later
than 14 days after sulfate in excess of the MCL has been detected in
the water. The notice shall be repeated at intervals of 6 months while
the sulfate concentration of the water in the distribution system
continues to exceed the MCL. If the area served by a public water
system is not served by a daily newspaper of general circulation,
notice shall instead be given by publication in a weekly newspaper of
general circulation. The notice shall define and describe the
geographic location served by the system. In communities where a
significant portion of the population speaks a language other than
English, the text shall be published in the appropriate language(s), in
addition to English. A telephone number(s) and an office location for
requesting Alternative Water delivery shall be provided. The notice
shall be provided at least once every six months by mail delivery (by
direct mail or with the water bill), or by hand delivery, not later
than 45 days after the sulfate MCL has been exceeded.
(ii) Text of the Notice. The PWS shall, within 60 days of confirmed
detection of sulfate in the distribution system, insert notices in each
customer's water utility bill containing the following mandatory
paragraph on the water bill itself in large bold print.
Warning: The water being supplied to you has high levels of
sulfate which can cause diarrhea in people who are not used to it.
If you have visitors in your home from outside the area, or if you
are expecting a baby, please read the enclosed notice for further
information.
The notices included in the water utility bill and those provided
to the media shall also contain the following mandatory language. Any
additional information presented shall be consistent with the
information in these paragraphs, and in plain English that can be
understood by laypersons. In communities where a significant portion of
the population speaks a language other than English, the text shall be
published in the appropriate language(s), in addition to English. The
text shall be as follows: ``Introduction. The United States
Environmental Protection Agency (EPA), the [insert name of State
primacy agency], and [insert name of water supplier] are concerned
about sulfate in your drinking water. Sulfate salts are found naturally
in soil and rock in certain areas of the country, including ours. With
the exception of infants, residents of the area should be accustomed to
the sulfate in our drinking water, and should not experience ill
effects. However, people who are not accustomed to high levels of
sulfate in their drinking water may experience diarrhea. Under Federal
law, we are required to provide sensitive populations with alternative
water until their bodies adapt to the sulfate concentrations in our
water. This brochure explains the simple steps you can take to protect
the sensitive populations: infants, visitors from outside the area, and
new residents.
Health Effects of Sulfate
Ingestion of sulfate in high concentrations is known to cause
diarrhea. The greatest risk is to infants, for whom prolonged diarrhea
can be dangerous. New residents and travelers may also experience
diarrhea when they first drink water with high levels of sulfate. After
approximately two weeks, adult's bodies become accustomed to the
sulfate, and the diarrhea stops. Available studies have not shown any
long-term or chronic adverse effects from consuming sulfate in drinking
water. Boiling the water will not reduce the sulfate content, and in
fact, will concentrate it through evaporation of the water.
The Alternative Water Program
If you are expecting a baby, if you are a new resident, or
expecting visitors from outside the area, please call [insert phone
number of water system] to request delivery of alternative water to
your home. We will provide you with sufficient water for the cooking
and drinking needs for each sensitive person. We will provide you with
two liters per day of bottled water for your infant for up to 20 weeks,
during which time you should gradually add tap water to the bottled
water. In this way, your baby will become gradually accustomed to the
sulfate in the water. We will provide your out-of-town guests with two
liters of bottled water per day for the period needed, up to a maximum
of six weeks. We will provide new residents with two liters per person
per day for up to six weeks. During that time, tap water should be
gradually mixed with the bottled water. Restaurants and other
establishments who are likely to serve at least some members of the
target population on a continual basis may be provided individual
treatment devices, depending on our evaluation of the size of the
target population and other circumstances.
(iii) New customers. The PWS shall provide notice of the following
to new customers or billing units prior to or on the date service
begins: Sulfate MCL exceedence in the water entering the distribution
system, the health effect of sulfate for target populations, and the
need to mix bottled water and tap water for gradual acclimation to
sulfate.
(iv) Pamphlets. PWSs shall deliver pamphlets to all physicians and
all medical facilities within the PWS service area, including, but not
limited to, city, county and State health departments, pharmacies,
public and private hospitals and clinics, family planning clinics and
local welfare agencies. The PWS shall request the operators of such
facilities to make the pamphlets available, in particular, to pregnant
women. The pamphlets shall contain the information in paragraph
(r)(3)(ii) of this section. The pamphlet shall define the extent of the
geographical service area in question.
(v) Signs. A prominent, permanent sign in a durable material, such
as plastic, shall be placed at each faucet, fountain or source of water
which could be used for drinking water in places such as restaurants,
hotels/motels, rest areas, campgrounds, gas stations and public areas
where not all taps will have treated water. If such facilities are
equipped with a POE device or with POU devices such that all taps
deliver water in compliance with the sulfate MCL, sign posting is not
required. The signs must state the location of the nearest source of
water which complies with the sulfate MCL and why precautions should be
taken by non-acclimated persons. The text of the sign, in multiple
languages where appropriate, shall be as follows:
This water contains high levels of sulfates. This mineral can
cause diarrhea in persons not accustomed to drinking water with high
sulfate content. Persistent diarrhea can cause dehydration. Special
care should be taken for infants. Bottled water is available nearby
at____________________.
(vi) Notices to the media. PWSs shall submit copies of the notice
described in paragraph (r)(3)(ii) of this section to radio and
television stations that broadcast to the community served by the water
system as soon as possible, but in no case later than 14 days after
sulfate in excess of the MCL has been detected in the water, and once
every six months while the water delivered into the distribution system
exceeds the sulfate MCL. The geographical service area in question
shall be indicated and clearly defined in the notice.
13. Section 141.33 is amended by adding paragraph (e) to read as
follows:
Sec. 141.33 Record maintenance.
* * * * *
(e) Record maintenance requirements concerning a PWS's delivery of
Alternative Water as a means of compliance with the MCL for sulfate are
contained in Sec. 141.23(r)(2)(ii).
Sec. 141.51 Maximum contaminant level goals for inorganic
contaminants. [Amended]
14. The table in Sec. 141.51(b) is amended by adding ``Sulfate'' in
alphabetical order under the column heading ``Contaminant'', and next
to it, under the column heading ``MCL(mg/l)'' adding ``500''.
Sec. 141.62 Maximum contaminant levels for inorganic contaminants.
[Amended]
15. In the last sentence in paragraph Sec. 141.62(b), the word
``and'' between ``(b)(8)'' and ``(b)(9)'' is removed, and ``and
(b)(16)'' is added after ``(b)(9)''.
Sec. 141.62 [Amended]
16. The table in Sec. 141.62(b) is amended by adding ``sulfate'' in
alphabetical order under the column heading ``Contaminant'' and next to
it, under the column heading ``MCL'' adding ``500''.
Sec. 141.62 [Amended]
17. The table in Sec. 141.62(c) is amended by adding ``Sulfate'' in
alphabetical order under the column heading ``Chemical Name'', and next
to it, under the column heading ``BAT'' adding ``5, 7, 9''.
18. Section 141.101 is amended by adding two sentences to the end
to read as follows:
Sec. 141.101 Use of other non-centralized treatment devices.
* * * The requirements of this section do not apply to the control
of sulfate in drinking water by public water systems in States
authorizing the Alternative Method of Compliance with the sulfate MCL.
Instead, a public water system that chooses to use bottled water or
point-of-use devices to achieve compliance with the MCL for sulfate
must meet the requirements of Sec. 141.23(r).
PART 142--NATIONAL PRIMARY DRINKING WATER REGULATIONS--
IMPLEMENTATION
19. The authority citation for part 142 continues to read as
follows:
Authority: 42 U.S.C. 300g, 300g-1, 300g-2, 300g-3, 300g-4, 300g-
5, 300g-6, 300j-4 and 300j-9.
20. Section 142.14 is amended by adding paragraph (d)(12) to read
as follows:
Sec. 142.14 Records kept by States.
* * * * *
(d) * * *
(12) Records of notification received pursuant to
Sec. 141.23(r)(1)(vi) of this chapter of the method of compliance
chosen by PWSs which exceed the sulfate MCL.
* * * * *
21. Section 142.15 is amended by adding paragraph (a)(4) to read as
follows:
Sec. 142.15 Reports by States.
* * * * *
(a) * * *
(4) Notification of public water systems authorized to implement
the Alternative Method of Compliance for sulfate.
* * * * *
22. Section 142.16 is amended by adding paragraph (f) to read as
follows:
Sec. 142.16 Special primacy requirements.
* * * * *
(f) Sulfate requirements. The national primary drinking water
regulation for sulfate in part 141 gives States the option to allow
PWSs to use the Alternative Method of Compliance with the sulfate MCL
contained in Secs. 141.23(r)(2) and (3) (see 141.23(r)(1)(ii)). If a
State chooses to allow PWSs to use the Alternative Method of
Compliance, its application for approval of a State program revision
must include the text of State laws and regulations that are no less
stringent than Secs. 141.23(r)(2) and (3) of this chapter. In addition,
the State's application must include a description of the State's
method for overseeing implementation by PWSs of the Alternative Method
of Compliance. Such a description must include actions the State will
take to assure compliance with bottled water requirements
(Sec. 141.23(r)(2)(v) of this chapter), POU and POE device requirements
(Sec. 141.23(r)(2)(vi) of this chapter), and public notification/
education program requirements (Sec. 141.23(r)(3) of this chapter).
23. Section 142.62 is amended by adding one sentence to the end of
paragraph (f) to read as follows:
Sec. 142.62 Variances and exemptions from the maximum contaminant
levels for organic and inorganic chemicals.
* * * * *
(f) * * * The State may authorize a public water system to use
bottled water, point-of-use or point-of entry devices to comply with
the sulfate MCL, pursuant to Secs. 141.23(r)(1) through (3) of this
chapter.
* * * * *
[FR Doc. 94-30953 Filed 12-19-94; 8:45 am]
BILLING CODE 6560-50-P