Tuesday
December 20, 1994
Part II
Environmental
Protection Agency
40 CFIR Parts 141, 142, and 143
National Primary Drinking Water
Regulations—Sulfate; Proposed Rule
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65578 Federal Register / Vol. 59, No. 243 / Tuesday, December 20, 1994 / Proposed Rules
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.
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., § 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, llth 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 Grotty :
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
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Federal Register / Vol. 59, No. 243 / Tuesday, December 20, 1994 / Proposed Rules 65579
B. Paperwork Reduction Act
C. Enhancing the Intergovernmental
Partnership
VII, References
Abbreviations Used in This Document
ASDVVA: 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 (ug)
s i milligram (mg))
MCLG: Maximum Contaminant Level Goal
MDL: Method Detection Limit
NAS: National Academy of Science
NCWS: Non-Community Water System
N1RS: National Inorganics and Radionuclides
Survey
NOAt 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
RSG 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
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65580 Federal Register / Vol. 59, No. 243 / Tuesday, December 20, 1994 / Proposed Rules
$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 Contami-
nant.
Proposed MCLG
Proposed MCL
Best Available Tech-
nologies.
Analytical Methods3 .
Sulfate
500mg/L1
500 mg/L
Reverse Osmosis
(RO)
ion Exchange2 (IE)
Electrodialysis (ED)
Colorimetry
Gravimetry
Ion Chromatography
1An alternative MCLG/MCL option of 400
mg/L was proposed in the July 25, 1990 no-
tice but is not proposed here.
2 For those systems with other anions that
need to be removed (such as nitrate), the re-
moval efficiency will decrease for those anions
since sulfate binds more strongly to the ex-
change 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
Contaminant
Sulfate
Base requirement i
Ground water
1 Sample/3 yr
Surface water
Annual S3mple
Trigger that in-
creases mon-
itoring
>MCL
Waivers
Yes2
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,
1 EPA also evaluates the costs to smaller systems
in its analysis of economic impacts.
"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.
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
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Federal Register / Vol. 59, No. 243 / Tuesday, December 20, 1994 / Proposed Rules 65581
contaminants must be regulated every
three years (section 1412(b)).
In the 1986 Amendments to the
SDVVA, 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 (SCU"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
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65582 Federal Register / Vol. 59, No. 243 / Tuesday, December 20, 1994 / Proposed Rules
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
Tables.
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 ng/m3. 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 the1
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 600
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,
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Federal Register / Vol. 59, No. 243 / Tuesday, December 20, 1994 / Proposed Rules 65583
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
I, 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
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65584 Federal Register / Vol. 59, No. 243 / Tuesday, December 20, 1994 / Proposed Rules
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 i
$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 re'gions. 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,
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Federal Register / Vol. 59, No. 243 / Tuesday, December 20, 1994 /Proposed Rules 65585
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)
BAT
Electrodialysis
Percent re-
moval
86-97
>75
80-90
Cost per
1,000 gal-
Ions
500-1000
population
$3.50
2.90
3.50
Cost per
1 ,000 gal-
lons
3,300-
10,000
population
$2.20
1.90
2.20
Cost per
1,000 gal-
lons
1 ,000,000
population
$1.00
1.40
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
Sulfate ...
Method
Colorimetry ....
Gravimetry
Ion chromatoaraohv
EPA 0)
375.2
300.0
ASTM m
4327-91
SM<3>
4500-SO4-F.
4500-SO4-C,D.
4110
<") "Methods for the Determination of Inorganic Substances in Environmental Samples", SPA/600/R/93/100. NTIS, U.S. Department of Com-
merce, 5285 Port Royal Road, Springfield, VA 22161, PB 94-121811, August 1993.
»> Annual Book of ASTM Standards, Vol. 11.01, 1993, American Society for Testing and Materials, 1916 Race Street, Philadelphia, PA 191Q3.
w 18lh edition of Standard Methods for the Examination of Water and Wastewater, American Public Health Association, American Water
Works Association, Water Environment Federation, 1992.
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65586 Federal Register / Vol. 59, No. 243 / Tuesday, December 20, 1994 / Proposed Rules
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
Contami-
nant
Sulfate ..
Method
Colorimetry
Gravimetry
Ion chroma-
tography.
Detection
limit (mg/L)
3
1
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 pf
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 PRESER-
VATION CONTAINER, AND HOLDING
TIME REQUIREMENTS
Contami-
nant
Sulfate ..
Preserv-
ative
Cool, 4
°C.
Con-
tainer1
Plastic
or
glass.
Maximum
holding
time2
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 § 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
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Federal Register / Vol. 59, No. 243 / Tuesday, December 20, 1994 / Proposed Rules 65587
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
PVVSs 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 tp
supply bottled water for the infant in
the household. EPA is not proposing to
require that bottled water be provided to
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Federal Register / Vol. 59, No. 243 / Tuesday, December 20, 1994 / Proposed Rules
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 § 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.
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Federal Register / Vol. 59, No. 243 / Tuesday, December 20, 1994 / Proposed Rules 65589
(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
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 householdsx2.6 personsx2 Iitersx42
days=6,552 liters
8 infantsx2 Iitersxl40 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
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Federal Register /Vol. 59, No. 243 / Tuesday, December 20, 1994 / Proposed Rules
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, PQEs, 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
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65591
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
those 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
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65592 Federal Register / Vol. 59, No. 243 / Tuesday, December 20, 1994 / Proposed Rules
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
§ 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
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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 § 142.62 (g) and
(h).
(1) Bottled water.
There are regulations in effect
(§ 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 §§ 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 ralemaking, 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 IH.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 (§ 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 PQU/
POE devices. Under § 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.
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65594 Federal Register / Vol. 59, No. 243 / Tuesday, December 20, 1994 / Proposed Rules
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
§ 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 § 141.23,
Inorganic Chemical Sampling and
Analytical Requirements, § 141.32,
Public Notification Requirements (i.e.,
mandatory health effects language to be
included in public notification or
violations), and § 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 § 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)(l)(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 § 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
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Federal Register / Vol. 59, No. 243 / Tuesday, December 20, 1994 / Proposed Rules 65595
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;
(t>) 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 \vhether 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
Water system type
Community Water Systems
Non-Transient Non-Community Systems
Transient Non-Community Systems
Total Number of Systems
Serving less
than 500 peo-
ple
350 (356)
250 (235)
1150 (1144)
1750 (1735)
Serving less
than 3300
people
500 (477)
250 (264)
1200 (1187)
1950 (1929)
Total of all
systems
500 (511)
250 (266)
1200 (1189)
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 S7 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 isitreated 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
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65596 Federal Register / Vol. 59, No. 243 / Tuesday, December 20, 1994 / Proposed Rules
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/
J-i«
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
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Federal Register / Vol. 59, No. 243 / Tuesday, December 20, 1994 / Proposed Rules 65597
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)
i
Dithllr* Mnfr /Pri /AH Wafpr •
Total •
Option 1
$71
7
7
0.5
86
Options 2/3
$8
7
0.5
16
Option 4
$139
7
0.5
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
OK_1(V)
101-500
cni_100K
No. of sys-
tems
1244
491
194
26
10
0
Option 1
$250
138
106
287
244
NA
Options 2/3
$145
56
24
4
2
NA
Option 4
$811
534
376
287
244
NA
iNA—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
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65598 Federal Register / Vol. 59, No. 243 / Tuesday, December 20, 1994 / Proposed Rules
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 $55+$ll
for the doctor and medication, plus 8
hours of the care giver's time
($19x8=$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
Out-Patient Cases:
Doctor Charges
Medication Charges
Days Lost Per Case
Value of Each Day Lost1
Hours Lost Per Case
Value of Each Hour Lost
Value Per Case:
Hospitalized Cases:2 ,
Number of Days
Hospital Cost Per Day
Value of Each Trip Day Lost3
Hours Lost Per Case
Value of Each Hour Lost
Value Per Case
Resident
infants
$55
$11
•)
fNAl
3
$19
$218
4
$750
fNA^
32
$19
$3,608
Travelling
infants
7i
ty^n
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Federal Register / Vol. 59, No. 243 / Tuesday, December 20, 1994 / Proposed Rules 65599
(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 § 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 (NOWAC), a group
composed of representatives from State,
local arid tribal governments in addition
to water suppliers and
environmentalists.
Thirdly, the Agency is developing
generic contacts with State, Tribal and
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Federal Register / Vol. 59, No. 243 / Tuesday, December 20, 1994 / Proposed Rules
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 i$ 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 1 7,1992),
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-l, 300g-2,
300g-3, 300g-4, 300g-5, 300g-6, 300J-4 and
300J-9.
§ 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 § 141.11 and
§ 141.62 (as appropriate) in accordance
with this section.
§141.23 [Amended]
3. In § 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)* * *
Contaminant
MCL (mg/l)
Methodology
Detection limit
(mg/l)
Sulfate
500 Colorimetry
Gravimetry
Ion Chromatography
3
1
0.02
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Federal Register / Vol. 59, No. 243 / Tuesday, December 20, 1994 / Proposed Rules
65601
§141.23 [Amended]
***** §141.23 [Amended]
*.mo, TA nH«n 6. In § 141.23(f)(l), "sulfate" is added 8. The table in § 141.23(k)(l) is
§ 4 £ § iScTintroductory text, * alphabetical order to the list of amended by adding an entry for
"sulfate" is added in alphabetical order contaminants
to the list of contaminants.
§141.23 [Amended]
5. In § 141.23[d) introductory text,
"and sulfate" is added after the word
"nitrate".
§141.23 [Amended]
7. In § 141.23(i)(l) and § 141.23(i)(2),
"sulfate" is added in alphabetical order
to the list of contaminants.
"Sulfate" in alphabetical order as
follows:
(k)* * *
CD* * *
Contaminant
Methodology
EPA' 5 '2
ASTM2
SM3
USGS4
Other
Sulfate Ion chromotography
Colorimetry
Gravimetry
8 300.0 D4327-91 . 4110
8375.2 4500-SO4-C,D
4500-SO4-F
§141.23 [Amended]
9. In § 141.23(k)(4), "Sulfate" is added
in alphabetical order to the list of
contaminants, and the table is amended
as follows:
*****
(k)* * *
(4)* * *
Contaml- Preserva- Con- Time3
nanl five' tainer* llme
Sulfate .... Cool, 4 P or G .... 28 days
§141.23 [Amended]
10. In § 141.23(k){5), introductory
text, "sulfate" is added in alphabetical
order to the list of contaminants.
§141.23 [Amended]
11. In § 141.23(k)(5](ii), the table is
amended by adding an entry for sulfate
as follows:
(k)* * *
(5}* * *
(ii)* * *
Contaminant
Sulfate
Acceptance limit
±15%at>10mg/l
§141.23 [Amended]
12. Section 141.23 is amended by
adding paragraph (r) to read as follows:
*****
(rKD Compliance with theMCLfor
Sulfate. (i) PWSs subject to the sulfate
MCL established under § 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 §§ 141.23(r)(2) and (3)
(program for providing Alternative
Water to Target Populations and
providing public notification and
education). The requirements of
§§ 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)(l)(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, § 141.23(r)(l)(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 § 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.
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Federal Register / Vol. 59, No. 243 / Tuesday, December 20, 1994 / Proposed Rules
(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
§ 142.62 (g)(l) 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 § 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
§ 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
M(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
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Federal Register / Vol. 59. No. 243 / Tuesday, December 20, 1994 / Proposed Rules
65603
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:
§ 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 § 141.23(r)(2)(ii).
§ 141.51 Maximum contaminant level goals
for inorganic contaminants. [Amended]
14. The table in § 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".
§ 141.62 Maximum contaminant levels for
inorganic contaminants. [Amended]
15. In the last sentence in paragraph
§ 141.62(b), the word "and" between
"(b)(8)" and "(b)(9)" is removed, and
"and (b)(16)" is added after "(b)(9)".
§141.62 [Amended]
16. The table in § 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".
§141.62 [Amended]
17. The table in § 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:
§ 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
§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-l, 300g-
2, 300g-3, 300g-4, 300g-5, 300g-6, 300J-4
and 300J-9.
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Federal Register / Vol. 59, No. 243 / Tuesday, December 20, 1994 / Proposed Rules
20. Section 142.14 is amended by
adding paragraph (d)(12) to read as
follows:
§ 142.14 Records kept by States.
*****
(d) * * *
(12) Records of notification received
pursuant to § 141.23(r)(l)(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:
§142.15 Reports by States.
*****
ta) * * *
(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:
§ 142.16 Special primacy requ irements.
*****
(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
§§ 141.23(r)(2) and (3) (see
141.23(r)(l)(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 §§ 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
(§ 141.23(r)(2)(v) of this chapter), POU
and POE device requirements
(§ 141.23(r)(2)(vi) of this chapter), and
public notification/education program
requirements (§ 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:
§ 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 §§ 141.23(r)(l) through (3)
of this chapter.
*****
[FR Doc. 94-30953 Filed 12-19-94; 8:45 am]
BILLING CODE 6560-50-P
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