[Federal Register Volume 59, Number 243 (Tuesday, December 20, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-30953]


[[Page Unknown]]

[Federal Register: December 20, 1994]


_______________________________________________________________________

Part II





Environmental Protection Agency





_______________________________________________________________________



40 CFR Parts 141, 142, and 143



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National Primary Drinking Water Regulations--Sulfate; Proposed Rule
ENVIRONMENTAL PROTECTION AGENCY

40 CFR Parts 141, 142 and 143

[WH-FRL-5120-7]
RIN 2040-AC07

 

Drinking Water; National Primary Drinking Water Regulations--
Sulfate; National Primary Drinking Water Regulation Implementation

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

-----------------------------------------------------------------------

SUMMARY: By this action, EPA is reproposing a maximum contaminant level 
goal (MCLG), and a National Primary Drinking Water Regulation (NPDWR) 
including a maximum contaminant level (MCL) for sulfate. There is a 
potential for an adverse health effect for infants, travelers, and new 
residents in areas that have high sulfate levels in their drinking 
water. The objective of this rule is to ensure that sulfate levels in 
drinking water provided by public water systems are reduced below 
levels of concern. The proposal contains alternatives that allow public 
water systems the flexibility to select compliance options appropriate 
to protect the population served.

DATES: Comments must be received on or before March 21, 1995. Comments 
received after this date may not be considered. A public hearing on the 
proposal will be held in Washington, DC on February 2, 1995 at the 
address listed below under ADDRESSES.

ADDRESSES: The Agency will hold a public hearing on the proposal at the 
following location: EPA Education Center Auditorium, 401 M Street SW., 
Washington, DC 20460, on February 2, 1995.
    The hearing will begin at 9:30 am, with registration at 9 am. The 
hearing will end at 4 pm, unless concluded earlier. Anyone planning to 
attend the public hearing (especially those who plan to make 
statements) may register in advance by writing the Sulfate Public 
Hearing Officer, Office of Ground Water and Drinking Water (4603), 
USEPA, 401 M Street SW., Washington, DC 20460; or by calling Tina 
Mazzocchetti, (703) 931-4600. Oral and written comments may be 
submitted at the public hearing. Persons who wish to make oral 
presentations are encouraged to have written copies (preferably three) 
of their complete comments for inclusion in the official record.
    Send written comments to the Sulfate Docket Clerk, Water Docket 
(MC-4101), U.S. Environmental Protection Agency, 401 M Street, SW., 
Washington, DC 20460. Please submit any references cited in your 
comments. EPA would appreciate an original and three copies of your 
comments and enclosures (including references). Commenters who want EPA 
to acknowledge receipt of their comments should include a self-
addressed, stamped envelope. No facsimiles (faxes) will be accepted 
because EPA cannot ensure that they will be submitted to the Water 
Docket.
    The proposed rule with supporting documents, including public 
comments and EPA responses to the Phase V rulemaking and this proposed 
rule, are available for review at the Water Docket at the address 
above. For access to Docket materials, call (202) 260-3027 between 9 am 
and 3:30 pm for an appointment.

FOR FURTHER INFORMATION CONTACT: The Safe Drinking Water Hotline, 
telephone 800-426-4791. The Hotline is open Monday through Friday, 
excluding Federal holidays, from 9 am to 5:30 pm Eastern Standard Time. 
For technical inquiries, contact Jude Andreasen, Drinking Water 
Standards Division, Office of Ground Water and Drinking Water (4603), 
U.S. Environmental Protection Agency, 401 M Street, SW., Washington, DC 
20460, 202-260-5555, or one of the EPA Regional Office contacts listed 
under Supplementary Information.

SUPPLEMENTARY INFORMATION: The Agency prefers that commenters type or 
print comments in ink, and cite, where possible, the paragraph(s) in 
this proposed regulation (e.g., Sec. 141.32(b)) to which each comment 
refers. Commenters should use a separate paragraph for each issue 
discussed. Technical inquiries can be directed to the contacts in 
regional offices as follows:

I. JFK Federal Bldg., Room 2203, One Congress Street, 11th floor, 
Boston, MA 02203, Phone: (617) 565-3484, Jerome Healey
II. 26 Federal Plaza, Room 824, New York, NY 10278, Phone: (212) 
264-1800, Walter Andrews
III. 841 Chestnut Street, Philadelphia, PA 19107, Phone: (215) 597-
8826, Stuart Kerzner
IV. 345 Courtland Street, NE., Atlanta, GA 30365, Phone: (404) 347-
2207, Wayne Aronson
V. 77 West Jackson Boulevard, Chicago, IL 60604, Phone: (312) 353-
2151, Ed Watters
VI. 1445 Ross Avenue, Dallas, TX 75202, Phone: (214) 655-7150, Tom 
Love
VII. 726 Minnesota Ave., Kansas City, KS 66101, Phone: (913) 551-
7032, Ralph Langemeier
VIII. One Denver Place, 999 18th Street, Suite 500, Denver, CO 
80202-2466, Phone: (303) 293-1652, Patrick Crotty
IX. 75 Hawthorne Street, San Francisco, CA 94105, Phone: (415) 744-
1817, Loretta Barsamian
X. 1200 Sixth Avenue, Seattle, WA 98101, Phone: (206) 553-4092, 
Kenneth Feigner

Table of Contents

I. Summary of Today's Action
II. Background
     A. Statutory Authority
     B. Regulatory History
     C. Sulfate General Information
III. Explanation of Today's Action
     A. Establishment of MCLG for Sulfate
     1. Health Effects
     2. Occurrence and Human Exposure
     3. Previously Proposed MCLG Public Comments, EPA Response
     4. Today's Proposed MCLG
     B. Establishment of NPDWR for Sulfate
     1. Methodology for Determination of MCLs
     2. Treatment Technologies and Costs
     3. Sulfate Analytical Methods
     a. Choice of Analytical Method
    b. Method Detection Limits and Practical Quantitation Levels
     c. Sulfate Sample Preservation, Container, and Holding Times
     d. Laboratory Certification
     e. Setting PE Sample Acceptance Limits for Sulfate
     4. Establishment of an NPDWR
     a. Today's Proposed MCL
     b. Lead Option for Implementing the MCL Requirement
     c. Method of Compliance
     (1) Community Water Systems
     (i) Bottled Water
    (ii) Public education/notification
    (2) Transient and Not-Transient, Non-Community Systems
    (i) Bottled Water and POU/POE Devices
    (ii) Public education/notification
    (3) Rationale
     d. Other Options Being Considered
     e. Implications of Options 1, 2 and 3
     f. Option 4
     g. Additional Option
     5. Compliance Monitoring Requirements
     a. Introduction
     b. Proposed Monitoring Requirements for Sulfate
    (1) Bottled Water
    (2) POU/POE Devices
    (3) Effective Date for Initial Monitoring
    (4) Sampling Location
    (5) Monitoring Frequency
    (6) Public Notice Requirements
     c. State Implementation
    (1) State Primacy Requirements
    (2) State Recordkeeping Requirements
    (3) State Reporting Requirements
     d. Variances and Exemptions
    (1) Variances
    (2) Exemptions
IV. Economic Analysis
     A. Executive Order 12866
     B. National Costs of the Proposed Rule
     1. Assumptions Used to Estimate Costs
     2. Costs to Households
     3. Assumptions Used to Estimate Benefits
     C. Comparison to Earlier Proposed Rule
     D. Annual Burden to PWSs and States
V. Summary of Selected Issues
VI. Other Requirements
     A. Regulatory Flexibility Analysis
     B. Paperwork Reduction Act
     C. Enhancing the Intergovernmental Partnership
VII. References

Abbreviations Used in This Document

ASDWA: Association of State Drinking Water Administrators
BAT: Best Available Technology
BTGA: Best Technology Generally Available
CRAVE: Cancer Risk Assessment Verification Endeavor
CWS: Community Water System
DWEL: Drinking Water Equivalent Level
ED: Electrodialysis
EIA: Economic Impact Analysis
EPA: Environmental Protection Agency
FDA: Food and Drug Administration
FR: Federal Register
FRDS: Federal Reporting Data System
ICR: Information Collection Request
IE: Ion Exchange
IOC: Inorganic Chemical
IRIS: Integrated Risk Information System
LCP: Laboratory Certification Program
LOAEL: Lowest-Observed-Adverse-Effect Level
MCL: Maximum Contaminant Level (expressed as mg/L) (1,000 micrograms 
(g) = 1 milligram (mg))
MCLG: Maximum Contaminant Level Goal
MDL: Method Detection Limit
NAS: National Academy of Science
NCWS: Non-Community Water System
NIRS: National Inorganics and Radionuclides Survey
NOA: Notice of Availability
NOAEL: No-Observed-Adverse-Effect Level
NOEL: No-Observed-Effect Level
NPDWR: National Primary Drinking Water Regulation
NTIS: National Technical Information Service
NTNCWS: Non-Transient Non-Community Water System
O&M: Operations & Maintenance
OMB: Office of Management and Budget
PE: Performance Evaluation
POE: Point-of-Entry Device
POU: Point-of-Use Device
PQL: Practical Quantitation Level
PWS: Public Water System
RFA: Regulatory Flexibility Analysis
RfD: Reference Dose
RIA: Regulatory Impact Analysis
RMCL: Recommended Maximum Contaminant Level
RO: Reverse Osmosis
RSC: Relative Source Contribution
RWS: Rural Water Survey
SDWA: Safe Drinking Water Act, or the ``Act,'' as amended in 1986
SMCL: Secondary Maximum Contaminant Level
SMF: Standardized Monitoring Framework
SOC: Synthetic Organic Chemical
T&C: Technology & Costs
TWS: Transient Non-Community Water System
URTH: Unreasonable Risk To Health
VOC: Volatile Organic Chemical
WS: Water Supply

List of Tables

Table 1--Proposed MCLG, BAT and Analytical Methods
Table 2--Compliance Monitoring Requirements
Table 3--Annual Costs of Proposed 1412 BAT
Table 4--Proposed Analytical Methods for Sulfate
Table 5--Proposed Methodology and Detection Limits for Sulfate
Table 6--Sulfate Sample Preservation, Container, and Holding Time 
Requirements
Table 7--Number of Systems Expected to Exceed 500 mg/L
Table 8--National Annual Sulfate Costs For Options 1-4
Table 9--Average Annualized Costs for Households
Table 10--Assumptions Made in Estimating Benefits
Table 11--Annual Burden Hours

I. Summary of Today's Action

    Today the Agency is proposing an MCLG of 500 mg/L, an MCL of 500 
mg/L, and other NPDWR requirements for sulfate. Sulfate is a unique 
contaminant for several reasons. The health effect associated with the 
ingestion of relatively high levels of sulfate in drinking water (i.e., 
ranging from loose stools to diarrhea) is acute and temporary, and is 
expected to last approximately two weeks. In addition, the health risk 
only applies to persons not already acclimated to high sulfate-
containing water: infants, travelers, and new residents. (For the 
purposes of this rule, infants are defined as children up to the age of 
12 months.) Today's proposed rule is also unique because it affects all 
public water systems, that is, community water systems, traveler non-
community water systems, and non-transient, non-community water 
systems. In the past, only regulations on microbial contaminants and 
nitrate have affected transient, non-community systems.
    EPA decided to defer promulgation of a sulfate standard, originally 
proposed July 25, 1990 (55 FR 30370) in order to identify an 
implementation approach which was tailored to the target populations. 
The approach EPA developed, working in cooperation with several States 
at a 1992 meeting, is innovative, and was designed specifically to 
provide flexibility to smaller systems. This approach could reduce 
compliance costs while still providing adequate protection of public 
health. It provides public water systems a means of compliance which is 
less expensive than central treatment, and it affords States 
flexibility in implementing the rule. Under this approach, the State 
would have the authority to allow the public water system (PWS), as one 
means of compliance with the sulfate MCL, to provide ``Alternative 
Water'' and public education/notification to the targeted, sensitive 
population. A PWS authorized to comply under this option would choose 
to supply customers with ``Alternative Water'', defined as either 
bottled water which has been monitored or certified to be in compliance 
with all EPA MCLs, or water treated by point-of-use (POU) or point-of-
entry (POE) devices.
    In the interest of reducing costs and maximizing flexibility, the 
proposal allows for unique means of compliance. Four options are being 
proposed for public comment. The lead option requires provision of 
alternative water to both transient adults (travelers and new 
residents) and infants. Two variations of the lead option require 
provision of alternative water to infants only. These two options 
differ only in the content of the public notification. In one case, 
only infants are considered at risk, and temporary diarrhea is 
considered as only an inconvenience for adults. In the other, both 
adults and infants are considered at risk, but public notification is 
deemed sufficient protection for adults. Because the lead option and 
its two variations represent a significant change in regulatory 
approach, EPA considered another, more conventional option. This fourth 
option would enable systems to seek a variance from the sulfate MCL. As 
a condition of receiving a variance, systems would be required to 
provide alternative water to their target populations, just as in the 
lead option. The only difference is that the relief for small systems 
would be provided through a different statutory mechanism. The Agency 
also considered limiting compliance to central treatment, which would 
be consistent with the approach for other contaminants, but which would 
not provide flexibility for smaller systems.
    The Agency expects that approximately 1,500 of the 2,000 affected 
systems would choose the lead option (Option 1) if it were available to 
them. The annual cost to those systems is estimated to be $7 million. 
The Agency has conservatively assumed that the remaining 500 systems 
would choose central treatment or regionalization in spite of the 
availability of Option 1. The cost to those systems is estimated to be 
$71 million. Total national cost of Option 1, including $8 million for 
State implementation and monitoring costs, is $86 million. If central 
treatment were the only means of compliance with the sulfate rule, the 
annual national cost would be $147 million (household costs ranging 
from $244 to $811). Household costs for Option 1 range from $106 to 
$287 per year, but this is an average of all households in all systems, 
including those choosing central treatment.
    In an effort to reduce the cost of this rule even further, the 
Agency is giving serious consideration to variations of Option 1. These 
variations, described as Options 2 and 3, would require public 
notification/education, but would only require the provision of bottled 
water which complies with EPA MCLs to infants. The difference between 
Options 2 and 3 is that Option 2 would target only infants as being at 
risk from an adverse effect, and Option 3 would target both adults and 
infants, but would propose that public notification/education is 
sufficient protection for adults. The Agency sees advantages and 
disadvantages to these alternative options, which are discussed later 
in this notice. The cost for either option would be $16 million, which 
includes $8 million for State implementation and monitoring costs. 
Household costs for these two options would be from $2 to $145 per 
year.
    EPA also considered Option 4, which would achieve the same result 
as Option 1, but with different administrative procedures involving a 
variance from the sulfate MCL. Under Option 4, the regulation would 
specify that the conditions for States to grant a variance from the 
sulfate MCL would include the same elements described for Option 1, 
namely public notification/education and Alternative Water provisions. 
These elements would be defined as BAT only for the purposes of Section 
1415 of the SDWA. The Agency believes that the unique nature of the 
sulfate health effect warrants a more flexible perspective on the 
implementation of the Act. The Agency recognizes that while the 
transitory nature of the diarrhetic effect of high-sulfate water may be 
uncomfortable and inconvenient for healthy adults, the potential risk 
to infants of diarrhea, as well as the dehydration and electrolyte 
imbalance which may be associated with it, are significant and 
potentially fatal if untreated.

               Table 1.--Proposed MCLG and MCL for Sulfate              
Inorganic Contaminant..............  Sulfate                            
Proposed MCLG......................  500 mg/L\1\                        
Proposed MCL.......................  500 mg/L                           
Best Available Technologies........  Reverse Osmosis (RO)               
                                     Ion Exchange\2\ (IE)               
                                     Electrodialysis (ED)               
Analytical Methods\3\..............  Colorimetry                        
                                     Gravimetry                         
                                     Ion Chromatography                 
\1\An alternative MCLG/MCL option of 400 mg/L was proposed in the July  
  25, 1990 notice but is not proposed here.                             
\2\For those systems with other anions that need to be removed (such as 
  nitrate), the removal efficiency will decrease for those anions since 
  sulfate binds more strongly to the exchange resin than other anions.  
\3\Acceptance limits=15% at 10 mg/L.             


        Table 2.--Compliance Monitoring Requirements\1\ For Systems Below the MCL, or With BAT Installed        
----------------------------------------------------------------------------------------------------------------
                                          Base requirement                      Trigger that                    
       Contaminant       --------------------------------------------------      increases           Waivers    
                                Ground water            Surface water            monitoring                     
----------------------------------------------------------------------------------------------------------------
Sulfate.................  1 Sample/3 yr..........  Annual sample..........  > MCL                Yes\2\         
----------------------------------------------------------------------------------------------------------------
\1\The compliance monitoring requirements apply to community water systems, transient non- community and non-   
  transient non-community water systems.                                                                        
\2\Sample/9 Years After 3 Samples < MCL.                                                                        

    The options in today's proposal would override the general 
prohibition in 40 CFR 141.101 on using bottled water which complies 
with EPA MCLs and point-of-use devices to achieve compliance with an 
MCL. This override would apply only to sulfate because of its unique 
characteristics.

II. Background

A. Statutory Authority

    The Safe Drinking Water Act (SDWA or ``the Act''), as amended in 
1986 (Pub. L. No. 99-339, 100 Stat. 642), requires EPA to publish 
``maximum contaminant level goals'' (MCLGs) for contaminants which, in 
the judgment of the Administrator, ``may have any adverse effect on the 
health of persons and which (are) known or anticipated to occur in 
public water systems'' (Section 1412(b)(3)(A)). MCLGs are to be set at 
a level at which ``no known or anticipated adverse effects on the 
health of persons occur and which allows an adequate margin of safety'' 
(Section 1412(b)(4)).
    Concurrent with EPA publishing an MCLG, which is a non-enforceable 
health goal, it must promulgate a National Primary Drinking Water 
Regulation (NPDWR) which includes either:
    (1) an MCL, or (2) a required treatment technique (Section 1401(1), 
1412(a)(3), and 1412(b)(7)(A)).
    An MCL must be set as close to the MCLG as feasible (Section 
1412(b)(4)). Under the Act, ``feasible'' means ``feasible with the use 
of the best technology, treatment techniques and other means which the 
Administrator finds, after examination for efficacy under field 
conditions and not solely under laboratory conditions (taking cost into 
consideration)'' (Section 1412(b)(5)). In setting MCLs, EPA considers 
the cost of treatment technology to large public water systems (i.e., 
>1,000,000 people) with relatively clean source water supplies (132 
Cong. Rec. S6287 (daily ed., May 21, 1986)).\1\ Each NPDWR that 
establishes an MCL must list the best available technology, treatment 
techniques, and other means that are feasible for meeting the MCL 
(Section 1412(b)(6)). NPDWRs include monitoring, analytical and quality 
assurance requirements, specifically, ``criteria and procedures, to 
assure a supply of drinking water which dependably complies with such 
maximum contaminant levels * * *.'' (Section 1401(1)(D)). Section 1445 
also authorizes EPA to promulgate monitoring requirements.
---------------------------------------------------------------------------

    \1\EPA also evaluates the costs to smaller systems in its 
analysis of economic impacts.
---------------------------------------------------------------------------

    A treatment technique may be required if it is not ``economically 
or technologically feasible'' to ascertain the level of a contaminant 
(Sections 1401(1) and 1412(b)(7)(A)).
    Section 1414(c) requires each owner or operator of a PWS to give 
notice to persons served by it of (1) any failure to comply with a 
maximum contaminant level, treatment technique, or testing procedure 
required by a NPDWR; (2) any failure to comply with any monitoring 
required pursuant to section 1445 of the Act;
    (3) the existence of a variance or exemption; and
    (4) any failure to comply with the requirements of any schedule 
prescribed pursuant to a variance or exemption.
    Under the 1986 Amendments to the SDWA, EPA was to complete the 
promulgation of NPDWRs for 83 listed contaminants, including sulfate, 
by June 19, 1989. After 1989, an additional 25 contaminants must be 
regulated every three years (section 1412(b)).
    In the 1986 Amendments to the SDWA, Congress required that MCLGs 
and MCLs be proposed and promulgated simultaneously (section 
1412(a)(3)). This change streamlined development of drinking water 
standards by combining two steps in the regulation development process. 
Section 1412(a)(2) renamed recommended maximum contaminant levels 
(RMCLs) as maximum contaminant level goals (MCLGs).

B. Regulatory History

    EPA is required by the 1986 amendments to the SDWA to issue a 
proposed and final standard for sulfate. EPA grouped sulfate with 23 
other organic and inorganic compounds in the ``Phase V'' regulatory 
package proposal. The 24 contaminants were among the last of the 
original list of 83 to be regulated by the SDWA. On June 25, 1990 EPA 
proposed the Phase V regulation, including sulfate (published at 55 FR 
30370, July 25, 1990). In the notice, EPA described the health effects 
associated with sulfate (see 55 FR 30382-83). The notice stated that 
the available scientific information suggests that an adverse health 
effect from ingesting high levels of sulfate is diarrhea and associated 
dehydration. Because local populations usually acclimate to high 
sulfate levels, the impact is primarily on infants, transient 
populations (e.g., business travelers, visitors and vacationers), and 
new residents. In the 1990 notice, EPA proposed alternative levels of 
400 mg/L and 500 mg/L for the MCLG for sulfate.
    In the Fall of 1991, as EPA was nearing publication of regulations 
for the 24 Phase V contaminants, it became apparent that the Agency had 
not reached a consensus on how to proceed with the sulfate regulation 
in light of concerns raised by the commenters. Given the high cost of 
the rule, the relatively low risk, and the need to explore alternative 
regulatory approaches targeted at the transient consumer, EPA decided 
to seek a deferral of a final regulatory decision on sulfate. The 
Agency needed more time to resolve issues that included: (1) Whether 
additional research is needed on how long it takes infants to acclimate 
to water with high sulfate content, (2) whether new regulatory 
approaches were needed for regulating a contaminant whose health effect 
is confined largely to transient populations, and (3) whether the 
Agency should revise its definition of BAT for small systems (i.e., 
what should be considered affordable for the small, transient non-
community water systems). For the above reasons, the regulation on 
sulfate was deferred. A new schedule has been established in connection 
with litigation brought over the schedule for regulating sulfate. This 
schedule requires EPA to finalize its regulatory action for sulfate by 
May 1996.
    The secondary maximum contaminant level (SMCL) for sulfate is 250 
mg/L and is based on aesthetic effects (i.e., taste and odor). EPA is 
not proposing changes in the SMCL for sulfate, but is requesting public 
comment on the correlation between sulfate concentrations, 
palatability, and consumption of high-sulfate water by the public.

C. Sulfate General Information

    Sulfate is the divalent anion (SO4-2). It exists in a 
variety of inorganic compounds and salts formed with metal cations. 
Sulfate salts with lower molecular weight alkali metals such as sodium, 
potassium, and magnesium are very water soluble and are often found in 
natural waters. Salts of higher molecular weight metals such as barium, 
iron or lead have very low water solubility.
    Sulfate is found in soil sediments and rocks, and occurs in the 
environment as a result of both natural processes and human activities. 
Specific data on the total production of all sulfates are not 
available, but production is expected to be thousands of tons per year; 
the use of sodium sulfate alone in 1987 was reported to be 792 tons. 
Sulfate is used for a variety of commercial purposes, including pickle 
liquor (sulfuric acid) for steel and metal industries, and as a reagent 
in manufacturing of products such as copper sulfate (a fungicide/
algicide).
    Sulfate may enter surface and ground water as a result of discharge 
or disposal of sulfate-containing wastes. In addition, sulfur oxides 
produced during the combustion of fossil fuels are transformed to 
sulfuric acid in the atmosphere. Through precipitation (i.e., acid 
rain), sulfuric acid can enter surface waters, lowering the pH and 
raising sulfate levels.

III. Explanation of Today's Action

A. Establishment of MCLG for Sulfate

    The MCLG for sulfate is reproposed today at a level of 500 mg/L. In 
this notice, EPA is responding to the public comments submitted in 
reference to the MCLG options contained in the July 1990 proposal. 
EPA's complete responses to the public comments on the previously 
proposed MCLGs appear in the Comment/Response Document that is included 
in the docket for this rulemaking.
    MCLGs are set at concentration levels at which no known or 
anticipated adverse health effects occur, allowing for an adequate 
margin of safety. The process for establishing an MCLG for a 
contaminant has been described in many documents, including the final 
Phase V rule issued in July 1992 (57 FR 31781-31783).
1. Health Effects
    The available information on the health effects of sulfate was 
fully described in the July 25, 1990 (55 FR 30370) Phase V proposal. 
Studies mentioned in that notice are summarized in the Health Criteria 
Document for Sulfate (US EPA, 1992), which is available for review and 
comment in the docket for this rulemaking. Since that time, EPA has 
funded additional studies on humans and piglets which are currently 
under review.
    In the July 25, 1990 notice, EPA stated that there was no evidence 
of adverse health effects in animals or humans from chronic exposure to 
sulfate in drinking water. The available health data indicate that 
chronic exposure to sulfate is not harmful to health.
    The acute effects noted from exposure to high levels of sulfate 
range from soft stools to diarrhea. Infants may be more sensitive to 
sulfate than healthy adults. Infants consume more water and food on a 
body weight basis than adults, and consequently ingest a higher dose of 
sulfate (per body weight) in drinking high-sulfate water than do 
adults. In infants, the greatest risk is from dehydration and 
electrolyte imbalance that may result from diarrhea. This effect can be 
fatal if untreated.
    It has been questioned whether the concentration of sulfate found 
in drinking water would cause significant dehydration in infants or 
adults. Schild (1980) reported that eight grams of sulfate retain 120 
milliliters of water in the intestine. In this case, an adult drinking 
two liters of water containing 1500 milligrams of sulfate per liter 
would ingest three grams of sulfate and retain 45 milliliters of water 
in the intestine. The Agency is requesting any scientific data which 
would support or refute the hypothesis that this decrease in available 
water is likely to cause dehydration and electrolyte imbalance in 
adults or infants.
    There are three documented case histories of infants, 5 to 12 
months old, who were given formulas prepared with water containing 630 
to 1,150 mg/L of sulfate (Chien, et al., 1968). These infants developed 
diarrhea shortly after they ingested the formula, but the effect 
subsided after use of the high sulfate water was discontinued. Cole 
(1992) evaluated this study and concluded that neither the potential 
effects of osmolarity, specifically hyperosmolarity, nor viral 
gastroenteritis had been considered as possible causes of the observed 
diarrhea. Thus, Cole suggested and the Agency agrees that the Chien 
study provides qualitative evidence of the effects of sulfate but 
should not be used quantitatively in a sulfate risk assessment.
    Similar effects have been observed in adults, but individuals seem 
to become acclimated to high sulfate levels in a short period of time, 
with a cessation of all ill effects.
    The laxative effect of sulfate is well-known. Peterson (1951) 
compiled the results of questionnaires sent to North Dakota residents 
and concluded that ``waters with 600 to 750 ppm sulfates should be 
looked upon with suspicion as they may or may not be laxative. Over 750 
ppm sulfates is generally a laxative water and below 600 ppm sulfates 
should be considered safe.'' Moore (1952) replotted the Peterson data 
and found that as sulfate concentrations increased from 500 to 1000 mg/
L, the number of adults reporting laxative effects also increased. At 
concentrations of sulfate above 1,000 mg/L, the majority of respondents 
noted a laxative effect. While it is not known how long is needed to 
achieve acclimation in adults or infants, EPA scientists believe the 
time to be approximately two weeks, based on mucosal cell turnover rate 
in the intestines.
    The Agency is using these studies to support the MCLG, although 
each has limitations. For example, in the Peterson (1951) study, there 
is no information available on the chemical composition or the 
microbiological quality of the water, nor on the length of time that 
people drank the water.
    There are insufficient data to calculate a precise and reliable 
quantification of the exact dose which will cause diarrhea in a given 
percentage of the susceptible population. Some sulfate salts are used 
as laxative agents. Their mechanism of action is known, and there is 
apparently little interest in the medical community in additional 
research on the subject. Acclimation to sulfate is assumed due to the 
fact that people living in regions with high-sulfate drinking water 
seem to have no adverse effect, whereas newcomers drinking that 
region's water will initially experience the laxative effect.
    In developing the MCLG for sulfate, issues were raised concerning 
the ability of infants to acclimate to sulfate in drinking water. In 
1992, EPA convened an expert panel to discuss the sulfate data base (US 
EPA, 1992). The panel (D.E.C. Cole, Children's Hospital, Halifax, Nova 
Scotia; M. Cassidy, George Washington University, Washington, DC; and 
M. Morris, State University of New York, Amherst, NY) concluded that 
the lack of data on the sulfate content and the osmolarity of the 
formulas used in the Chien et al. (1968) study prevents it from being a 
reliable estimate of the level of sulfate that would induce diarrhea in 
infants. They concluded that: (1) Additional studies on sulfate are 
desirable, (2) the Chien et al. (1968) study cannot be used 
quantitatively, (3) the 500 mg/L value for sulfate is conservative for 
adults, and there are no differences between sulfate levels of 400 and 
500 mg/L, (4) the three cases of diarrhea reported in the Chien study 
may or may not be attributable to sulfate, and (5) acute short-term 
effects are the appropriate focus for risk assessment and further 
research.
    The panel members recommended additional research with piglets and 
humans. EPA agreed and initiated studies in collaboration with the 
University of North Carolina School of Medicine and the North Carolina 
State University Department of Animal Science. These studies have been 
completed and are undergoing internal and external peer review.
2. Occurrence and Human Exposure
    The available information on the occurrence and human exposure to 
sulfate was fully described in the July 25, 1990 proposal. Since that 
time, additional State data have been gathered and used to update the 
information in Table 8.
    Review of data sources for estimating national occurrence levels of 
sulfate included: The Community Water Supply Study (CWSS) released in 
1969; the Rural Water Survey (RWS) from the late 1970s; new State 
survey data from Utah, North and South Dakota, and Texas: The Federal 
Reporting Data System (FRDS) and STORET, EPA's computerized water 
quality data base. In the CWSS, 106 surface water supplies sampled had 
an apparent detection limit of 1 mg/L. For the ground water supplies 
the mean of the positive sulfate detections was approximately 43 mg/L 
(range of 1 to 480 mg/L), and for surface water it was approximately 49 
mg/L (range of 2 to 358 mg/L). The Rural Water Survey (RWS) reported a 
lower frequency of positives and a higher mean of the positive values, 
but this lower frequency probably reflects the higher detection limit 
of 15 mg/L. In the RWS, sulfate was reported to be present in 271 of 
494 ground water supplies with a mean of about 98 mg/L (range of 10 to 
1,000 mg/L) for the positives (some laboratories can achieve accuracy 
at levels lower than the published detection limit of 15 mg/L). In 
surface water, it was found in 101 of 154 supplies, with a mean of 53 
mg/L (range of 15 to 321 mg/L) for the positives.
    As noted above, sulfate can be formed in the atmosphere, and EPA 
has reported ambient levels during the period of 1980-1986 to range 
from 0.2 to 199.4 g/m\3\. Since the amounts of sulfate that 
could be transferred from the atmosphere through the pulmonary system 
to the gastrointestinal tract are minuscule compared to what could be 
ingested in drinking water, atmospheric levels are not of concern for 
the purposes of this rule.
    No information is available on the occurrence of sulfate in foods, 
nor are there any estimates on dietary intake. The Agency did not 
follow its usual practice of determining a relative source contribution 
(RSC) factor. As with certain other inorganic contaminants (nitrate, 
fluoride, barium, manganese), calculation of RSC is not appropriate for 
sulfate because the MCLG is derived directly from human exposure to the 
contaminant in drinking water.
3. Previously Proposed MCLG
    In July 1990, EPA proposed two alternative options for the sulfate 
MCLG based on the available health information. The first option was to 
set the MCLG at 400 mg/L, based on a Science Advisory Board (SAB) 
conclusion that sulfate's mode of action is well known and some human 
data are available indicating that ill effects occur only at 
concentrations above 600 mg/L (Peterson, 1951). SAB applied a small 
uncertainty factor of 1.5 to the 600P mg/L level to give a recommended 
MCLG of 400 mg/L. Their recommendation corresponded to the World Health 
Organization (WHO) sulfate standard of 400 mg/L, which is based on 
aesthetic considerations.
    The second option was to set the MCLG at 500 mg/L. As a basis for 
choosing this option, EPA referred to the survey conducted by Peterson 
(1951) and evaluated by Moore (1952). Combining the questionnaire 
respondents into discrete groups, Moore indicated that the number of 
adults reporting laxative effects increased at sulfate concentrations 
above 500 mg/L.
    The Health Protection Branch of Health and Welfare/Canada has 
indicated to EPA (Canadian Guidelines, 1991) that the maximum 
acceptable concentration of sulfate in water is 500 mg/L, considered an 
aesthetic objective, since ``at this level sulfate gives an 
objectionable taste, but is still below the level at which we would 
expect to see deleterious health effects''. The Agency notes that the 
Canadian sulfate guideline of 500 mg/L and the lack of health problems 
reported at that level lends support to the proposed MCLG. Canada does 
not yet have national drinking water regulations. Their guidelines are 
offered to the provinces, which may choose to adopt them as provincial 
regulations.

Public Comments

    There were 15 separate comments concerning sulfate on the 1990 
proposed rule. Several commenters believed that EPA should not regulate 
sulfate due to a lack of adequate health data, lack of chronic effects 
and because people acclimate to the laxative effects of sulfate. Eleven 
commenters stated that if it were necessary to regulate sulfate, that 
the MCLG should be higher than 500 mg/L (between 600 and 1,000 mg/L). 
The remaining four commenters stated that 500 mg/L was protective. One 
commenter stated that the usual approach for deriving the MCLG--an RfD 
calculation--should be used for sulfate. Another commenter cited a July 
17, 1989 letter from the Metals Subcommittee of the Science Advisory 
Board's Environmental Health Committee to the Administrator stating 
that the Subcommittee could not support the setting of an acute MCLG, 
and recommending additional study before regulation. Several commenters 
urged EPA not to regulate sulfate, stating that a secondary MCL is 
sufficient. They noted that infants as well as adults acclimate to 
sulfate, sulfate is present in food, and the WHO guidelines are based 
on taste considerations and not health effects. Several commenters 
noted that systems which do not serve the target population, infants in 
particular, should be excused from complying with the sulfate 
regulation. Several commenters questioned EPA's cost analysis.

EPA Response

    Some commenters noted that no chronic health effects have been 
associated with long-term exposure to high levels of sulfate. However, 
sulfate can have acute adverse effects on non-acclimated persons. The 
population at risk is readily identified and targeted for protective 
measures. While the laxative effect eases and disappears as the person 
acclimates to the high sulfate concentration, the individual is subject 
to debilitation during the acclimation period.
    Diarrhea and/or laxative effects have been reported in infants 
ingesting water with high levels of sulfate and in adults at 
concentrations in the 500 to 1000 mg/L range. EPA believes an MCL level 
of 500 mg/L will be sufficiently protective of infants and adults. An 
RfD for sulfate has not been determined.
    SMCLs for aesthetic qualities relating to the public acceptance of 
drinking water are not federally enforceable, and intended only as 
guidance for the States. SMCLs do not meet the statutory requirement to 
set an NPDWR for sulfate.
    The requirements for transient and non-transient, non-community 
water systems which do not serve the target population frequently would 
be minimal. They could achieve compliance by placing permanent signs at 
drinking fountains and having bottled water which complies with EPA 
MCLs available for visitors.
    The Agency has updated the occurrence data and the cost analysis 
since the Phase V proposal.
4. Today's Proposed MCLG
    Today EPA is proposing an MCLG of 500 mg/L which represents the 
level at which no known or anticipated adverse effects on human health 
occur, and which allows for an adequate margin of safety based on 
current data. As a basis for choosing this level, EPA notes that the 
survey conducted by Peterson (1951) and evaluated by Moore (1952) 
indicated that the number of people reporting laxative effects greatly 
increased at sulfate concentrations above 500 mg/L. This concentration 
is considered protective of infants based on the information reported 
by Chien et al. (1968).
    EPA believes that the MCLG for sulfate should be based on the 
potential for causing loose stools and diarrhea. Infants are at risk 
from diarrhea regardless of the cause, and unacclimated adults may also 
be at risk. A standard to limit the intake of sulfate will protect the 
infant population and unacclimated adults from potential adverse 
effects.
    EPA requests comment on this proposed MCLG. EPA particularly 
requests any new data or any other new information that may be 
submitted in support of or opposing the reproposed sulfate MCLG of 500 
mg/L. In light of comments opposing the regulation of sulfate, the 
Agency is also requesting any new data or information that would 
support a higher level for the MCLG. The Agency is particularly 
interested in comments that raise issues other than those that EPA has 
already considered and responded to above and in the record for today's 
proposal.

B. Establishment of NPDWR for Sulfate

1. Methodology for Determination of MCLs
    The SDWA directs EPA to set the MCL ``as close to'' the MCLG ``as 
is feasible.'' The term ``feasible'' means ``feasible with the use of 
the best technology, treatment techniques, and other means, which the 
Administrator finds, after examination for efficacy under field 
conditions and not solely under laboratory conditions, are available 
(taking costs into consideration)'', (SDWA section 1412(b)(5)). Each 
NPDWR that establishes an MCL lists the technology, treatment 
techniques, and other means which the Administrator finds to be 
feasible for meeting the MCL (SDWA section 1412(b)(6)).
    The present statutory standard for BAT under 1412(b)(5) represents 
a change from the provision prior to 1986, which required EPA to judge 
feasibility on the basis of ``best technologies generally available'' 
(BTGA). The 1986 Amendments to the SDWA changed BTGA to BAT and added 
the requirement that BAT must be tested for efficacy under field 
conditions, not just under laboratory conditions. The legislative 
history explains that Congress removed the term ``generally'' to assure 
that MCLs ``reflect the full extent of current technology capability'' 
(S. Rep. No. 56, 99th Cong., 1st Session at 6 (1985)). EPA has 
concluded that the statutory term ``best available technology'' is a 
broader standard than ``best technology generally available'' and that 
this standard allows EPA to select a technology that is not necessarily 
in widespread use, as long as its performance has been validated in a 
reliable manner. In addition, EPA believes that the technology selected 
need not necessarily have been field tested for each specific 
contaminant but, rather, that the operating conditions may be projected 
for a specific contaminant using a field tested technology from 
laboratory or pilot systems data.
    Based on the statutory directive for setting the MCLs, EPA derives 
the MCLs based on an evaluation of (1) the availability and performance 
of various technologies for removing the contaminant, and (2) the costs 
of applying those technologies. Other technology factors considered in 
determining the MCL include the ability of laboratories to measure 
accurately and consistently the level of the contaminant with available 
analytical methods.
    EPA's initial step in deriving the MCL is to make an engineering 
assessment of technologies that are capable of removing a contaminant 
from drinking water. EPA reviews the available data to determine 
technologies that have the highest removal efficiencies, are compatible 
with other water treatment processes, and are not limited to a 
particular geographic region.
    Based on the removal capabilities of the various technologies, EPA 
calculates the level of each contaminant that is achievable by their 
application to large systems with relatively clean raw water sources. 
(See H.R. Rep. 1185, 93rd Cong., 2nd Sess. at 13 (1974); 132 Cong. Rec. 
S6287, May 21, 1986, statement of Sen. Durenberger.)
    When considering costs to control contaminants, EPA analyzes 
whether the technology is reasonably affordable by regional and large 
metropolitan PWSs (See H.R. Rep. No. 93-1185 at 18 (1974) and 132 Cong. 
Rec. S6287 (May 21, 1986) (statement of Sen. Durenberger)). EPA also 
evaluates the total national compliance costs, considering the number 
of systems that will have to install treatment in order to comply with 
the MCL. The resulting total national costs vary depending upon the 
concentration level chosen as the MCL. The more stringent the MCL, the 
greater the number of systems that may have to install BAT to achieve 
compliance and the higher the national cost.
    The feasibility of setting the MCL at a precise level is also 
influenced by laboratory ability to measure the contaminant reliably. 
Because compliance with the MCL is determined by analysis with approved 
analytical techniques, the ability to analyze consistently and 
accurately for a contaminant at the MCL is important for enforcing a 
regulatory standard. Thus, the feasibility of meeting a particular 
level is affected by the ability of analytical methods to determine 
with sufficient precision and accuracy whether such a level is actually 
being achieved.
2. Treatment Technologies and Costs
    In the July 25, 1990 proposal, EPA identified two technologies as 
BATs under Section 1412 of the SDWA for sulfate: Reverse osmosis (RO) 
and ion exchange (IE). EPA believes that the costs of these 
technologies to large systems are reasonable, and that these 
technologies are compatible with other water treatment processes in 
different regions of the U.S. These technologies and the costs of using 
them are described as follows:
    Reverse Osmosis. RO uses semi-permeable membranes to remove a high 
percentage of almost all inorganic ions. The technology is relatively 
insensitive to flow and total dissolved solids (TDS). The effectiveness 
of RO is adversely affected by the presence of turbidity, iron, 
manganese, silica, or scale-producing constituents in the source water. 
If pretreatment is not already in place to remove these constituents, 
additional costs may be incurred to install other technologies (e.g., 
pH adjustment, filtration, or scale-prevention additives). The cost 
generated by the model includes the cost of a scale inhibitor. On the 
other hand, in situations where high dissolved solids and/or several 
contaminants may have to be removed simultaneously, the RO process may 
offer an especially desirable and cost-effective approach to their 
removal. Less chlorine may be needed due to removal of many bacteria 
and viruses during the RO process.
    Disadvantages to RO include fouling of membranes either from 
scaling or from water with high organic content and a reject stream of 
20% to 50% of the water flow. It is also possible that corrosion 
control chemicals will be needed after RO, and a more qualified 
operator may be needed.
    Full scale tests indicate that RO is capable of removing between 86 
and 97 percent of the sulfate, and is effectively used for the 
reduction of contaminants other than sulfate. Estimated cost for 
reducing sulfate by RO range from $3.50/1,000 gallons for systems 
serving between 500 and 1,000 persons to $1.00/1,000 gallons for 
systems serving more than 1,000,000 persons. High sulfate levels are 
typically associated with high levels of TDS, which can indicate the 
presence of other inorganics; in such cases, RO becomes a cost 
effective treatment technology because it removes those other 
inorganics as well. Since the removal efficiency required for sulfate 
will typically be less than 86 percent, a portion of the water can be 
treated and blended with an untreated portion to reduce the cost of 
this process.
    Commenters to the Phase V proposed rule expressed concerns 
regarding the potential costs associated with disposal of wastes 
generated by treatment processes such as RO, particularly in water-
scarce regions. The Agency believes that wastewater would be minimized, 
since only a portion of source water containing elevated sulfate levels 
would need to be treated, and would then be blended with source water. 
With an MCL of 500 mg/L, EPA believes blending treated water and source 
water would greatly reduce the reject stream.
    Ion Exchange. IE reduces sulfate concentrations to levels below the 
MCLG of 500 mg/L at reasonable costs to large systems. Typical sulfate 
anion removals using IE are greater than 75 percent in full-scale 
studies that evaluated influent concentrations close to drinking water 
levels. Estimated costs for IE to reduce sulfate concentrations range 
from $2.90/1,000 gallons for systems serving between 500 and 1,000 
persons to $1.40/1,000 gallons for systems serving more than 1,000,000 
people. When the removal efficiency required for sulfate is less than 
75 percent, a portion of the water can be treated and blended with an 
untreated portion to reduce cost. For those systems with other anions 
that need to be removed (such as nitrate), the removal efficiency will 
decrease for those anions since sulfate binds more strongly to the 
exchange resin than other anions. A disadvantage of IE is that it may 
not be feasible at high levels of TDS.
    EPA received a number of public comments on the proposal to select 
RO and IE as BATs for the Phase V inorganic contaminants in general and 
for sulfate in particular. EPA's responses are in the comment-response 
document for the Phase V rulemaking and in the preamble to the final 
rule (57 FR 31809-12). In the preamble, EPA responded to comments on 
sulfate in particular concerning the disposal of wash brines from IE 
and RO treatments in water-scarce areas and on the costs of using RO 
and IE to treat for sulfate. EPA is not aware of any new information on 
these two technologies or costs since the proposal. Interested parties 
are invited to submit any new public comments or new information on the 
selection of RO and IE as BAT for sulfate.
    Electrodialysis. Since the Phase V proposal, EPA has identified 
electrodialysis (ED) as an additional proposed BAT. EPA requests 
comment on its conclusion that electrodialysis should also be 
considered BAT for sulfate.
    ED was the first membrane process developed for desalting brackish 
waters, and was commercially available in the 1950's. In the early 
1970's, a major technological improvement was made, called 
electrodialysis reversal. Recovery ratios increased from the 50% to 60% 
range to 80% to 90% recovery.
    In ED, feed water containing dissolved ions is pumped across 
electrified membranes. The positive ions migrate to the negative 
electrode, and the negative ions migrate to the positive electrode, and 
are effectively trapped in alternating compartments. The partially 
deionized/dilute stream is circulated through additional stages until 
the desired purity is obtained. Since this is a unidirectional process, 
membrane fouling and mineral scale formation tend to degrade system 
performance. Some pretreatment may be required, such as clarification, 
presoftening, or treatment with acid or anti-scaling agents.
    Electrodialysis reversal (EDR) is the same process but with the 
polarity of the current automatically reversed at regular 15 to 30-
minute intervals. This changes the direction of ion movement within the 
membrane stack. As a result, foulants and scale tend to be removed from 
the membrane surfaces and carried away during the purge period. EDR 
requires minimum pretreatment and is very tolerant of system upsets, 
shock chlorination, and long-term operation at temperatures up to 45 C. 
Sulfate removal of 84% was achieved in a 1990 pilot study in Virginia, 
in which efficiency and costs for RO and EDR were compared (AWWA, 
1991).
    Operating costs for EDR are comparable to those for RO. All 
reference to ED as BAT for sulfate removal in this notice will refer to 
electrodialysis reversal, rather than unidirectional electrodialysis. 
Table 3 summarizes the efficiency and cost of the treatment 
technologies proposed as BATs for sulfate, and indicates that each can 
reduce the contaminant level from the maximum expected occurrence level 
to below the proposed MCLG. The costs in Table 3 are representative of 
annual operation and maintenance (O & M) costs plus annualized capital 
costs, and may differ depending on local conditions. Costs may be lower 
if sulfate concentration levels encountered in the raw water are lower 
than those used for the calculations, or higher if additional system-
specific treatment or storage requirements are needed. The general 
assumptions used to develop the treatment costs include: Capital costs 
amortized over 20 years at a 7 percent interest rate; engineering fees; 
contractor overhead and profit; late 1991 power, fuel, labor and 
chemical costs. The removal efficiencies cited in Table 3 are what is 
possible, and are not directly linked with the cited costs. These costs 
are linked with the efficiency needed to achieve the sulfate MCL.

                                          Table 3. Annual Costs of Proposed 1412 BAT for Sulfate (1991 Dollars)                                         
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                               Cost per 1,000                                                           
                             BAT                                  Percent     gallons500-1000   Cost per 1,000 gallons3,300-        Cost per 1,000      
                                                                  removal        population           10,000population        gallons1,000,000population
--------------------------------------------------------------------------------------------------------------------------------------------------------
Reverse osmosis..............................................  86-97                  $3.50                   $2.20                         $1.00       
Ion Exchange.................................................  >75                     2.90                    1.90                          1.40       
Electrodialysis..............................................  80-90                   3.50                    2.20                          1.00       
--------------------------------------------------------------------------------------------------------------------------------------------------------

3. Sulfate Analytical Methods
    a. Choice of analytical method. The reliability of analytical 
methods used for compliance monitoring is critical at the MCL. EPA 
evaluated the availability, costs and the performance of analytical 
methods for measuring sulfate, and considered the ability of 
laboratories to measure consistently and accurately for sulfate at the 
level of the proposed MCL.
    In selecting analytical methods, EPA considers five factors:
    (a) Reliability (i.e., precision/accuracy) of the analytical 
results;
    (b) Specificity in the presence of interferences;
    (c) Availability of enough equipment and trained personnel to 
implement a national monitoring program;
    (d) Simplicity of analysis to permit routine use; and
    (e) Cost of analysis to water supply systems.
    Sulfate has an SMCL of 250 mg/L for which EPA recommends 
measurements be made with an EPA method or a Standard Method (SM) 
method (40 CFR 143.4(b)), each of which uses a turbidimetric analytical 
technique. The July 1990 proposal listed analytical methods for sulfate 
that use one of four analytical techniques: turbidimetry, colorimetry, 
ion chromatography, and gravimetry. The July 1992 regulations did not 
regulate sulfate, but specified a colorimetric analytical technique to 
measure sulfate as an unregulated contaminant (40 CFR 141.409(n)(12)). 
However, the regulations did not list specific colorimetric methods. In 
an analytical methods proposal (58 FR 60622, December 15, 1993) EPA 
removed this ambiguity by identifying several colorimetric methods. The 
December 1993 proposal also proposed methods that use other analytical 
techniques, and improved laboratory efficiency by allowing all sulfate 
methods to be used for both secondary and unregulated contaminant 
monitoring.
    Today EPA is proposing methods that use colorimetric, gravimetric 
or ion chromatographic analytical techniques. The methods are proposed 
for analysis of sulfate as regulated and as a secondary contaminant. 
For information on the precision and accuracy of these methods, EPA 
refers readers to the references in Table 4.

                                Table 4.--Proposed Analytical Methods for Sulfate                               
----------------------------------------------------------------------------------------------------------------
         Contaminant                     Method              EPA (1)        ASTM (2)              SM (3)        
----------------------------------------------------------------------------------------------------------------
Sulfate.....................  Colorimetry................        375.2  ...............  4500-SO4-F.            
                              Gravimetry.................  ...........  ...............  4500-SO4-C,D.          
                              Ion chromatography.........        300.0  4327-91........  4110                   
----------------------------------------------------------------------------------------------------------------
(1) ``Methods for the Determination of Inorganic Substances in Environmental Samples'', EPA/600/R/93/100. NTIS, 
  U.S. Department of Commerce, 5285 Port Royal Road, Springfield, VA 22161, PB 94-121811, August 1993.          
(2) Annual Book of ASTM Standards, Vol. 11.01, 1993, American Society for Testing and Materials, 1916 Race      
  Street, Philadelphia, PA 19103.                                                                               
(3) 18th edition of Standard Methods for the Examination of Water and Wastewater, American Public Health        
  Association, American Water Works Association, Water Environment Federation, 1992.                            

    EPA is not proposing turbidimetric methods because the methods are 
inadequate. The operating range of turbidimetric methods is 0 to 40 mg/
L, which requires excessive dilution of the sample to cover the range 
between the SMCL (250 mg/L) and the proposed MCL (500 mg/L). EPA 
recommends that compliance samples not be diluted more than four or 
five-fold to obtain reliable and reproducible results. The gravimetric 
and colorimetric chromatographic methods require acceptable dilution of 
the sample to measure samples containing more than 350 mg/L of sulfate.
    Colorimetric and gravimetric methods have been used for many years 
to measure sulfate in water, and were described in the July 1990 
proposal. As stated in the July 1992 rule, EPA agrees with comments 
that only methylthymol blue, not chloranilate, colorimetric methods are 
suitable for sulfate analysis. Therefore, EPA is only proposing 
methylthymol blue colorimetric methods for sulfate analysis.
    Ion chromatographic methods have been approved for measurement of 
nitrate and nitrite (40 CFR 141.23) in drinking water. These methods 
have been described or discussed in the July 1990 and the December 1993 
proposals, and in 54 FR 22097 (May 22, 1989). EPA is proposing ion 
chromatographic methods for sulfate analysis only with the suppressed 
column option. EPA has no data to support use of a ``non-suppressed'' 
column (57 FR 31800), and the Agency is not proposing to approve this 
option in any ion chromatographic method.
    EPA believes the proposed analytical methods are technologically 
and economically feasible for sulfate monitoring. The analytical cost 
for sulfate is $10 to $30 per sample. EPA believes these costs are 
affordable. Actual analytical costs may vary with the laboratory, 
analytical technique selected, the total number of samples and other 
factors. The number of laboratories that routinely participate in EPA's 
Water Supply and Water Pollution performance evaluation studies 
indicates that many laboratories have the capability to conduct 
analysis for sulfate.
    Sulfate has a long history as a water quality parameter. There is a 
large body of performance data available for water pollution studies. 
The proposed analytical methods have detection limits much lower than 
the proposed MCLG for sulfate. The detection limit for a given 
contaminant varies with the analytical method (Table 5).
    b. Method detection limits and practical quantitation levels. EPA 
determines practical quantitation levels (PQLs) for each substance for 
the purpose of integrating analytical chemistry data into regulation 
development. The PQL yields a limit on measurement and identifies 
specific precision and accuracy requirements which EPA uses to develop 
regulatory requirements. As such, PQLs are a regulatory device rather 
than a standard that labs must specifically demonstrate they can meet. 
The PQLs for inorganic compounds are determined based on the method 
detection limits (MDLs) and the results from performance evaluation 
data.

     Table 5.--Proposed Methodology and Detection Limits for Sulfate    
------------------------------------------------------------------------
                                                              Detection 
 Contaminant                      Method                      limit (mg/
                                                                  L)    
------------------------------------------------------------------------
Sulfate.....  Colorimetry..................................         3   
              Gravimetry...................................         1   
              Ion chromatography...........................         0.02
------------------------------------------------------------------------

    The PQL for sulfate was determined using the MCL as well as EPA and 
State laboratory data from Water Pollution PE studies using the 
procedure described in 54 FR 22100 (May 22, 1989). A PQL of 10 mg/L was 
proposed for sulfate in the Phase V proposed rule (55 FR 30411, July 
25, 1990). Since the detection limit using the colorimetric method is 3 
mg/L, EPA is soliciting comment on whether a higher PQL of 30 mg/L 
should be set in order to retain the colorimetric method.
    c. Sulfate sample preservation, container and holding times. 
Requirements for sample preservation, containers and holding times 
listed in Table 6 were proposed for sulfate in the 1990 proposal. No 
comments were received on these specifications. The Agency is 
reproposing these requirements today.

    Table 6.--Sulfate Sample Preservation Container, and Holding Time   
                              Requirements                              
------------------------------------------------------------------------
                                                              Maximum   
    Contaminant        Preservative       Container\1\        holding   
                                                              time\2\   
------------------------------------------------------------------------
Sulfate...........  Cool, 4  deg.C...  Plastic or glass.  28 days.      
------------------------------------------------------------------------
\1\Container may be a hard or soft, plastic or glass material.          
\2\Samples should always be analyzed as soon after collection as        
  possible.                                                             

    d. Laboratory certification. Today EPA is proposing that only 
certified laboratories be allowed to analyze samples for compliance 
with the proposed MCL for sulfate. EPA recognizes that the 
effectiveness of today's proposed regulations depends on the ability of 
laboratories to reliably analyze contaminants at low levels. EPA has a 
drinking water laboratory certification program that States must adopt 
as a part of primacy. (40 CFR 142.10(b)) EPA's Manual for the 
Certification of Laboratories Analyzing Drinking Water, EPA/570/9-90/
008, April, 1990, specifies minimum criteria which States must use to 
implement their drinking water laboratory certification program.
    Performance evaluation (PE) samples are an important tool in EPA's 
laboratory certification program. The samples are provided by EPA or 
the States to laboratories seeking certification. To obtain and 
maintain certification a laboratory must use an approved method, and at 
least once a year successfully analyze an appropriate PE sample. 
Successful analysis requires that a laboratory report a concentration 
of sulfate in the PE-sample that is within the acceptance limits. 
Specification of these proposed limits, which are listed in drinking 
water regulations at Sec. 141.23(k), is discussed below.
    e. Setting PE sample acceptance limits for sulfate. Acceptable 
performance has historically been set by EPA using two different 
approaches: (1) Regressions from performance of preselected 
laboratories (using 95 percent confidence limits), or (2) specified 
accuracy requirements. Acceptance limits based on specified accuracy 
requirements are developed from existing PE study data. When there are 
insufficient PE data to determine expected laboratory performance, EPA 
determines acceptance limits from individual study statistics based 
upon 95 percent confidence limits. After sufficient performance data 
are generated from PE studies, EPA will develop fixed acceptance limits 
using a ``plus or minus of the true value approach.'' The true value 
approach requires each laboratory to demonstrate its ability to perform 
within pre-defined limits. Laboratory performance is evaluated using a 
constant yardstick independent of performance achieved by other 
laboratories participating in the same study. A fixed criterion based 
on a percent error around the ``true'' value reflects the experience 
obtained from numerous laboratories and includes relationships of the 
accuracy and precision of the measurement to the concentration of the 
analyte. It also assumes little or no bias in the analytical methods 
that may result in average reporting values different from the 
reference ``true'' value. This concept assures that reported results 
can be related to the percentage variance from the PQL.
    Performance data are available for sulfate at concentrations 
proposed for regulation. The data are sufficient to set fixed 
acceptance limits of  15% for sulfate PE samples. The 
acceptance limits are estimated using the approach described in 54 FR 
22132.
4. Establishment of a NPDWR
    a. Today's Proposed MCL. Today EPA is proposing an MCL for sulfate 
of 500 mg/L, which is equal to the proposed MCLG. EPA believes that 
costs for large systems are reasonable and affordable, and that it is 
technologically feasible for PWSs to achieve this level for sulfate. 
EPA also believes that the flexibility afforded by Option 1 allows 
small systems to comply with the MCL in a way that is reasonable and 
affordable.
    Examination of the BATs identified above (RO, IE, and ED) indicates 
that each can reduce the levels of sulfate from the maximum expected 
occurrence levels to levels below the proposed MCLG of 500 mg/L 
(minimum removal efficiencies of 86%, 75%, and 80%, respectively). The 
maximum reported occurrence level for sulfate in a national study (RWS) 
is 1,000 mg/L, although individual State data have shown levels twice 
as high. Each of these technologies is currently available, has been 
installed in PWSs, is compatible with other water treatment processes, 
and can remove sulfate from the maximum occurrence level to below the 
proposed MCLG. EPA is proposing an MCL for sulfate based upon an 
analysis of several factors, including:
    (1) The effectiveness of BAT in reducing sulfate levels from 
influent concentrations to the MCLG.
    (2) The feasibility (including costs) of applying BAT. EPA 
considered the availability of the technology and the costs of 
installation and operation for large systems.
    (3) The performance of available analytical methods.
    b. Lead option for implementing the MCL requirement. As described 
in the Regulatory Background section, EPA determined that sulfate is 
found primarily in small PWSs in the western part of the U.S., and that 
compliance with the sulfate MCL would place a significant burden on 
these systems. EPA decided that a requirement for PWSs to comply with 
the sulfate MCL by treating all of their source water might be 
excessive since high sulfate levels affect only persons who are not 
acclimated to the water. Therefore, the Agency decided in 1992 to defer 
the regulation for sulfate in order to consider ways of allowing PWSs 
to comply with the MCL that would not require central treatment.
    To develop alternative options for complying with the MCL, EPA held 
a meeting with interested States and the Association of State Drinking 
Water Administrators (ASDWA). In November 1992, officials from Texas, 
South Dakota, Colorado, and New Mexico, ASDWA staff, EPA Regional 
staff, and EPA Headquarters staff met to explore regulatory options for 
sulfate. They discussed the regulatory process, a toxicological profile 
of sulfate, and State perspectives on sulfate regulation, health 
effects and implementation options. Neither the issue of whether or not 
to regulate sulfate nor the MCL/MCLG levels were topics of discussion. 
The participants felt that the sulfate regulation should give the 
States flexibility. After the discussions at this meeting, most of the 
States present supported the conclusion that PWSs should be allowed to 
protect their customers from the risk of sulfate levels exceeding the 
MCL either by centralized treatment or through public education/
notification and provision of Alternative Water. The outline of a 
regulatory option that included all of these elements was formulated. 
Each of the components was directed at a certain population and the 
majority agreed that those components, together, would be adequately 
protective. The option developed at that meeting is essentially Option 
1, being proposed today. In the past, EPA has not generally set 
restrictions or conditions on the means of compliance with the MCL. 
Traditionally, EPA simply identifies the central treatment technologies 
that are considered BAT and then sets the MCL based on the capabilities 
of those technologies to remove the contaminant. PWSs are not required 
to use the identified BATs but must achieve compliance with the MCL. 
EPA regulations prohibit PWSs from using bottled water or POU devices 
to achieve compliance with the MCL. In addition, the regulations 
prohibit PWSs from using POE devices to achieve compliance with the MCL 
unless the PWS meets certain conditions for ensuring effective 
protection of all consumers. See 40 CFR 141.100 and 141.101. In Option 
1, EPA proposes to override the general prohibition on the use of 
bottled water and POU/POE devices and to allow States to authorize PWSs 
to use these methods to achieve compliance with the MCL.
    c. Method of compliance. The State would have the authority under 
Option 1 to allow PWSs to achieve compliance with the sulfate MCL by 
one of two methods. The PWS could comply either by using conventional 
central treatment or by providing Alternative Water. With the State's 
authorization, PWSs would have the choice of supplying bottled water 
which complies with EPA MCLs, POU or POE devices to target populations. 
Under Option 1, PWSs that provide Alternative Water would also need to 
meet certain public education/notification requirements. Transient 
systems would also have to provide Alternative Water, but their public 
notification requirement would be posting of signs, unless POE/POU 
devices brought all taps into compliance. This approach directly 
focuses protection on the sensitive populations: Infants, travelers and 
new residents. Under Option 1, any program developed by a PWS would 
need to contain the following provisions or others which it can 
demonstrate are at least as stringent and protective:
    (1) Community Water Systems
    (i) Bottled water.
    PWSs would need to provide and deliver two liters of bottled water 
per person per day (unless the customer requests less), on request, to 
households with infants, new residents, or transients (visitors). The 
bottled water would have to have been monitored or certified to be in 
compliance with all EPA MCLs. PWSs would be allowed to deliver enough 
water for several weeks, or the entire time period, at once, and would 
not be required to provide daily delivery. Infants, up to one year old, 
would receive bottled water for a maximum of 20 weeks from the date of 
request. Since a mother may nurse her infant during the first year, it 
would be her decision as to when to begin giving the infant tap water. 
Each new resident (person moving to the high-sulfate community from 
another location) would receive bottled water for a maximum of six 
weeks. New residents with infants up to one year old would receive 
bottled water for their infant for 20 weeks. New residents with infants 
older than one year would receive bottled water for themselves and 
their infant for six weeks. Since new residents would be informed about 
the Alternative Water by the PWS at the time of starting water service 
to their residence, the six weeks would begin at that time. Travelers 
(guests visiting residents and hotel guests) would receive bottled 
water for the period requested, not to exceed six weeks. In resident 
households with infants, the public water system would only need to 
supply bottled water for the infant in the household. EPA is not 
proposing to require that bottled water be provided to resident 
pregnant women prior to childbirth, since there seems to be no transfer 
of sulfate through the placenta.
    The rule would require PWSs supplying Alternative Water to 
determine an equitable way of recouping their expenses in providing 
that service without charging a premium to the recipients of the 
Alternative Water. EPA believes that an additional charge for 
Alternative Water (above and beyond what would normally be charged for 
the water if it had been delivered through the distribution system) 
would be a disincentive to a consumer's decision to request Alternative 
Water and receive protection from high levels of sulfate. Therefore, 
the proposed rule would prohibit PWSs from charging a premium. The 
Agency believes this is necessary in order to ``assure a supply of 
drinking water which dependably complies with'' the sulfate MCL (see 
SDWA Section 1401(1)(D)). Each utility would need to determine the best 
way to meet its operating expenses without imposing a premium on the 
subpopulation of customers that is receiving Alternative Water under 
the sulfate rule. For example, a PWS could charge the same unit cost 
for each liter of bottled water as it charges for centrally-distributed 
water. The number of liters of bottled water delivered to a household 
would simply be added to the number of liters of centrally-distributed 
water that appears on the meter, and the same unit cost would apply to 
the entire volume. EPA requests comment on whether it is appropriate to 
restrict the PWS's fee structure in this way. In particular, the Agency 
is interested in whether there are State or local ratemaking laws or 
other laws that bear on this issue.
    Two liters per day is the amount of water selected to be provided 
since that is the consumption level used by EPA in calculating risk 
estimates, and is the 85th percentile consumption level of water for 
the U.S. population. Infants are considered to consume one liter per 
day, but since they comprise a small portion of the target population, 
two liters per day for all members of the target population is retained 
for simplicity of implementation. Twenty weeks was chosen as the period 
for providing bottled water to infants since EPA staff scientists 
believe that this is a sufficiently lengthy period for infants to 
become gradually acclimated to high sulfate-containing water. 
Similarly, six weeks was chosen as the period for providing bottled 
water to new residents and travelers (guests) to allow gradual 
acclimation. Although two weeks is the period necessary to acclimate to 
high sulfate levels if a person is exposed continually to high-sulfate 
water, this rapid time frame would require the person to experience the 
adverse effect. In addition, new residents and travelers are likely to 
have many activities occupying their attention which may prevent them 
from accomplishing the acclimation in a shorter time period. EPA is 
requesting comment on these allotted time periods.
    The notice provided to customers by the PWS would advise that 
during the period when bottled water is provided, there should be 
mixing of bottled water with tap water to allow gradual acclimation of 
the digestive system to the high-sulfate water. If gradual introduction 
of tap water is not done, there could still be adverse health effects 
when use of bottled water ceases.
    The PWS would be responsible for providing bottled water which 
complies with EPA MCLs on request to any household which has an infant 
or travelers (guests), and to any household with new residents who have 
moved to the community from outside the service area.
    Monitoring requirements to ensure that the bottled water meets the 
sulfate MCL and other MCLs are explained in the section below on 
Compliance Monitoring Requirements.
    PWSs would need to maintain a record of public requests for bottled 
water, either by a telephone log or other means, by which the date of 
the request and the date of delivery are recorded and maintained for 
State verification.
    If the public notification is done effectively, it is not 
anticipated that emergency delivery of bottled water will be necessary. 
Customers should have the time to notify the PWS well in advance of the 
desired delivery date. In the event that a customer has not had access 
to the public notification and is unable to procure bottled water prior 
to the normal delivery by the PWS, the PWS should have the ability to 
provide an emergency delivery within 24 hours of receiving the request.
    (ii) Public Education/Notification.
    Public education and public notification are important in making 
people aware of the potential adverse health effects of high levels of 
sulfate and educating them about how to protect themselves if they are 
within the targeted population. For CWSs, there are four components to 
the proposed public education and public notification requirement: 
Notices in bills, pamphlets, signs and notices to the media. In 
communities where a significant portion of the population speaks a 
language other than English, the text would need to be in the 
appropriate language(s), in addition to English.
    Notices in Bills. PWSs would be required to use their bill notices 
to inform residents of the sulfate content in their water and its 
potential impact on non-acclimated persons. The compliance requirements 
for mail delivery would be the same as those for the general public 
notification mail delivery requirements in Sec. 141.32(a) (2) and (3), 
except that the interval for sulfate notification is proposed to be 
every six months rather than three months. EPA is proposing to specify 
a six-month interval to assure that a pregnant woman would receive at 
least one notice during the term of her pregnancy. The notice would 
have to be typed in bold lettering on the bill itself. There would also 
need to be an additional page with more information on the potential 
health effect from ingesting high levels of sulfate in drinking water. 
That page would include information about how expectant mothers and 
residents can request and receive bottled water for infants and guests, 
how to mix tap water with bottled water over time to gradually 
acclimate the person to sulfate, as well as a section reassuring the 
consumer that there are no ill effects from high sulfate-containing 
water for residents.
    The PWS would also need to provide the same notice to new customers 
or billing units prior to or at the time service begins.
    Pamphlets. PWSs would be required to provide pamphlets to all 
medical facilities, which includes, but is not limited to city, county 
and State health departments, pharmacies, public and private hospitals 
and clinics, family planning clinics and local welfare agencies. The 
PWS would need to request that the operators of those facilities make 
the pamphlets available to pregnant women. The pamphlets would contain 
the information listed above for notices in bills.
    Signs. PWSs would be required to post permanent, prominent and 
visible signs in all public areas where not all taps will have treated 
water.
    Notices to the Media. PWSs would be required to submit copies of 
the notice described above to radio and television stations that 
broadcast to the community served by the water system when sulfate in 
excess of the MCL has been detected in the water, and once every six 
months while the water delivered into the distribution system exceeds 
the sulfate MCL. The geographical service area in question would have 
to be indicated and clearly defined in the notice.
    (2) Transient Systems and Non-Transient, Non-Community Systems
    (i) Bottled Water and POU/POE Devices
    Transient systems, which comprise most of the affected systems 
(1,200 of 1,950), and non-transient, non-community systems would be 
required to make either bottled water which complies with EPA MCLs or 
water treated with a POU/POE device available for travelers at 
establishments in the service area. Where the target population is 
affected on a relatively continual basis, PWSs may find it more cost-
effective to provide POU or POE devices. Where the system rarely serves 
members of the target population, it might choose to have a supply of 
bottled water on hand. Non-transient, non-community water systems, such 
as schools, factories and hospitals, might choose to install POEs in 
their cafeterias. PWSs would be responsible for maintaining POU/POE 
devices to ensure their continuing effectiveness.
    (ii) Public Education/Notification
    Public notification for transient systems and non-transient, non-
community systems would be posting of signs. Such systems have no 
customers to ``bill'', and notices to the media and pamphlets would not 
be effective or necessary. PWSs would be required to post permanent, 
prominent and visible signs, made of durable material such as plastic, 
in places such as rest areas, campgrounds, gas stations and public 
areas. The signs would target travelers and newcomers, and would alert 
the public to the health effects of sulfate and the nearest location of 
drinking water for individuals not acclimated to high sulfate levels. 
The signs would have to be placed in any location where all taps (i.e., 
faucets, fountains, or other source of water that could be used for 
drinking) are not providing water in compliance with the sulfate MCL. 
If the location has a POE device, posting would not be necessary, since 
all taps would provide water that complies with the MCL. In the case of 
campgrounds, sources such as hand pumps or trailer hook-ups would be 
posted with signs, and bottled water could be available at the entrance 
gate or registration area. The Agency recognizes that there are 
unmanned, remote campgrounds in the national parks system, and requests 
comment on the means of compliance for those systems.
    (3) Rationale
    The sanctioning of Alternative Water as a means of compliance is an 
innovative approach that EPA has developed in recognition of the 
special circumstances and concerns surrounding the sulfate regulation. 
The proposed option would provide Alternative Water to sensitive 
populations only for the period of time needed for acclimation. The 
Alternative Water approach is appropriate in this case because the 
target populations are readily identifiable and because their need is 
short-term. Option 1 provides PWSs flexibility and seeks to alleviate 
the financial burden that central treatment might entail for small 
PWSs, and as such is in accordance with the objectives of the 
Regulatory Flexibility Act.
    EPA believes that the requirements of Option 1 for PWSs to provide 
bottled water which complies with EPA MCLs or POU/POE devices and to 
provide public notice and education, taken together, will assure a 
supply of drinking water to the Target Population which dependably 
complies with the MCL for sulfate (see SDWA Section 1401(1)(D).
    As detailed below in the section on costs, EPA finds that this 
Alternative Water approach would result in an annual national cost of 
$86 million annually, as compared to an annual cost for central 
treatment by all affected systems of $147 million. The $86 million 
estimate would be substantially lower except that EPA assumed 
conservatively that about 25% of affected systems would choose central 
treatment or regionalization even with Option 1 available to them. Of 
the $86 million, $7 million would be the cost to the 1,500 systems 
choosing the public notification/Alternative Water method of 
compliance, and $71 million would be the cost to the 500 systems 
choosing central treatment.
    To understand how the logistics of the option would work, the 
Agency chose two system sizes: A PWS serving a town of 500 people, and 
another serving a town of 3,300 people. As very few systems 
(approximately 40) serving 3,300 people or more are expected to exceed 
the sulfate MCL, this system size was chosen to illustrate that it 
would be more cost-effective for a system of that size to centrally 
treat. Costs were calculated by using national averages.
    In a population of 500, the Agency assumed (based on analysis of 
U.S. Census Bureau and Current Population Reports data) that there 
would be eight households (500 times 1.68%) with infants and 30 
households with new residents (500 times 16.4% divided by 2.6 persons 
per household) at any given time. (EPA assumed that an average 
household contains 2.6 people. New residents and infants would require 
Alternative Water for 6 weeks and 20 weeks, respectively. A system 
serving this population of 500 would be required to deliver a maximum 
of approximately 8,800 liters of bottled water annually, or 24 liters 
per day, as illustrated by the calculations below.

30 households x 2.6 persons x 2 liters x 42 days=6,552 liters
8 infants x 2 liters x 140 days=2,240 liters
Total Annual Bottled Water Needs=8,792 liters
Average Daily Bottled Water Needs 8,792/365 days=24 liters

    The above calculation is given as an example only, and the 24-liter 
figure is a high estimate. The required mixing of tap water with 
bottled water over time for infants and new residents would reduce 
their consumption of bottled water. The cost analysis in the RIA for 
this rulemaking assumes that bottled water will represent, on average, 
half the water consumption for infants and new residents, and that 
customers will exercise their option to have less than 2 liters per day 
delivered over the entire period.
    Although it is up to the water system to decide how to deliver the 
water, the Agency finds that the system could contract the delivery 
service out to a bottled water supplier or could procure and distribute 
bottled water itself. For the sake of simplifying the model, EPA 
assumed that a town with a population of 500 would not have to install 
any POUs or POEs, and would rely entirely on bottled water for the 
target population. The Agency recognizes that, in actuality, some 
percentage of such towns may have a restaurant and/or gas station, and 
could use a POU/POE device. However, these towns would be few in 
number, and the simplified model is retained for costing purposes only. 
If such a town had very few travelers passing through, for example, a 
restaurant or gas station might find it more cost-effective to use 
permanent signs and have bottled water available for those few 
travelers. EPA assumes that systems which rarely serve the target 
population would comply by posting signs and having bottled water 
available for visitors, rather than install POE/POU devices. The Agency 
solicits comment on the types of Alternative Water that PWSs would 
choose.
    For a town with a population of 3300, the logistics become more 
complicated. The estimated number of households with infants increases 
from 8 to 55. The number of households with new residents becomes 210, 
and the number of liters of bottled water to be delivered per day is 
approximately 170. It is also estimated that there will be 3 POU units 
per town. The Agency thinks that few PWSs serving populations this 
large will choose Option 1, and will choose instead to centrally treat.
    There are several disadvantages to Option 1. First, it requires 
persons to learn about sulfate and take action to protect themselves. 
Second, because high-sulfate water is still available at the tap, 
Option 1 does not guarantee that all target audiences will be 
protected. The Agency requests comment on the feasibility, equity, 
enforceability, and attractiveness of the option.
    Although EPA believes that allowing compliance with the MCL through 
the use of POUs, POEs, and bottled water is acceptable in the case of 
sulfate, the Agency continues to believe that it should not be allowed 
in the case of other drinking water contaminants, for which the general 
prohibitions in 40 CFR 141.100 and 141.101 still would apply. Option 1 
proposes to override the prohibition in these sections against using 
bottled water and POU devices as a means of compliance with the sulfate 
MCL because of its unique characteristics. The susceptible population 
is limited, and the health effects are short-lived, so the logistics of 
Option 1 are feasible for smaller systems. The effects are immediate, 
so the cause/effect relationship of drinking water containing high 
levels of sulfate can be easily demonstrated, and the affected 
population can be readily convinced of the need for precautions. EPA is 
unaware of any other drinking water contaminant having these unique 
features. Therefore, EPA considers Alternative Water and public 
notification/education to be acceptable means for compliance with the 
MCL for sulfate, but not for other contaminants, given current 
information on health risk and treatment costs.
    Because of the burden of administering Alternative Water in larger 
systems, noncompliance and the difficulties of enforcement become 
larger concerns. Therefore, EPA considered, but decided against, 
limiting the availability of Option 1 to smaller systems (e.g., systems 
serving fewer than 3,300 persons). Such a limitation would be unlikely 
to have any practical effect since, for cost efficiency reasons, 
systems above this size would probably choose central treatment. Also, 
EPA's occurrence projections indicate that few if any systems above 
3,300 are likely to exceed a sulfate MCL of 500 mg/L.
    d. Other options being considered. Option 1 above is EPA's 
preferred approach to regulating sulfate in drinking water and is being 
proposed by EPA today. EPA believes that Option 1 fully complies with 
SDWA's scheme for establishing drinking water regulations and is the 
best approach for regulating sulfate. However, there has been 
considerable discussion as to the necessity for federal regulatory 
action in protecting the public from the real, yet temporary laxative 
effect of sulfate. Various commentors on the 1990 proposal argued that 
sulfate should not be regulated at all because diarrhea does not 
present a significant risk to health, but rather is only an 
inconvenience.
    The Agency has a statutory requirement to regulate sulfate. In 
light of the above comments, EPA is seriously considering the following 
additional options for regulating sulfate. EPA solicits public comment 
and scientific evidence on all of the options being considered.
    Option 2  Under this option, the sulfate MCL and MCLG would be set 
at 500 mg/L. However, the target population would be limited to only 
infants, that is, only infants would need to be provided drinking water 
that meets the MCL for sulfate. The rationale for this option is that 
infants are the only population subgroup potentially subject to a 
significant risk to health, not due to the initial effect (diarrhea), 
but due to their inability to modify their environment or fluid intake, 
and the possibility that dehydration could occur if no action is taken. 
Under this Option, EPA would be taking the position that the laxative 
effect is more of an inconvenience than an adverse health effect in 
adults, and that no protection of adults is necessary.
    The implementation of Option 2 would require the same public 
notification/education activities outlined in Option 1, with 
modifications in the text to limit the target population to infants. 
The text would state that only infants are exposed to significant risk 
from sulfate ingestion. Just as in Option 1, CWSs in excess of the 
sulfate MCL would be required to provide notices in bills, signs, 
pamphlets and media notices to their customers in the service area. 
These CWSs would be required to deliver Alternative Water upon request 
to households with infants for a maximum of 20 weeks during their first 
year of life. Transient systems and non-transient, non-community 
systems would be required to post signs and assure a supply of bottled 
water for infants if there is any possibility of an infant being 
present at the facility. Since the target population is comprised only 
of infants, the allocation of bottled water would be 1 liter per day, 
rather than the 2 liters per day proposed under Option 1 for adults and 
infants. For costing purposes, the Agency assumes that under Option 2, 
no PWS would choose central treatment as a means of compliance. This 
assumption is based on the relatively small number of infants (less 
than 2% of a given population) and the option's relatively low 
administrative and logistical costs. The cost of arranging delivery of 
bottled water and providing public notification in the service area 
would be lower than the cost of installing central treatment. However, 
it is possible that a large PWS, in anticipation of future regulations 
for other contaminants, or to comply with other existing regulations 
for contaminants that can be removed by the same treatment technologies 
as sulfate (e.g., RO), might, in reality, choose central treatment. 
Such a system may find the permanent requirement to provide public 
notification and bottled water to the target population to be a long-
term administrative burden that is ultimately less cost-effective than 
central treatment. A disadvantage to this option is the possible 
precedent that would be set by an EPA statement that diarrhea is not 
considered an adverse effect for adults.
    Option 3  Option 3 differs from Option 2 in the definition of the 
targetpopulation. The target population would be composed, as in Option 
1, of infants and transient adults (including new residents), all of 
whom are subject to the adverse effect. However, unlike Option 1, there 
would be two different strategies under Option 3 to protect the two 
target population subgroups, infants and adults. As in Option 2, 
Alternative Water would have to be provided for infants. Unlike Option 
2 however, PWSs would be required to notify transient adults of their 
risk, even though not required to provide them with Alternative Water. 
Public education/notification requirements would be identical to those 
described for Option 1 for both subgroups, except that the text of the 
notices would state that Alternative Water is only provided for infants 
upon request of the parent. Just as in Option 2, CWSs exceeding the 
sulfate MCL would be required to provide notices in bills, signs, 
pamphlets and media notices to their customers in the service area, and 
deliver bottled water upon request to households with infants for a 
maximum of 20 weeks. Similarly, transient and non-transient, non-
community systems would be required to post signs and maintain a supply 
of bottled water.
    The rationale for Option 3 is that it is necessary to set the MCL 
at a protective level, but sufficient for compliance purposes to 
provide notification/education to the affected adult population. This 
option is based on the theory that adequate protection for adults can 
be achieved through proper education and notification. Informed adults 
would be able to reduce or avoid the effect by taking the initiative to 
purchase bottled water or otherwise abstain from drinking tap water. 
Infants, on the other hand, depend on adults for their survival, and 
the minimization of diarrhea's effects depends on the adult's gradual 
mixing of the infant's tap water with water that complies with the 
sulfate MCL. Consequently, more stringent requirements (provision of 
Alternative Water) would be imposed to ensure protection of infants. 
The disadvantage of this option is that it requires members of the 
affected public to protect themselves after being notified of a 
potential risk.
    e. Implications of Options 1, 2 and 3. Options 1, 2 and 3 represent 
a significant change from the Agency's approach in other drinking water 
regulations. The principal advantage to these options is the reduced 
cost to systems. However, there are potential disadvantages in terms of 
policy implications to adopting any of these options which should be 
addressed and debated with public participation. EPA recognizes that 
there may be concern over the decision not to require PWSs to treat 
their water centrally but to allow them to supply water at levels that 
may exceed the sulfate MCL, and to rely on the provision of Alternative 
Water at the consumer's end to ensure ultimate compliance. A 
disadvantage of these three options is that it is possible that some 
members of sensitive subpopulations may still drink untreated tap water 
from the distribution system and thus, not be protected. Consumers may 
be unaware of the need to request Alternative Water, or may find it too 
burdensome to do so. While EPA believes that this strategy conforms 
with the requirements and intent of the Safe Drinking Water Act, EPA 
requests comment on this issue.
    Options 1, 2 and 3 also require more assertive action by the public 
to ensure protection, especially those served by a CWS. This is true 
for Option 1, where adults in the target population would be required 
to contact the CWS for Alternative Water, which would then be 
delivered. Even more assertive action is needed for Option 3, since 
informed adults would have to obtain Alternative Water themselves. For 
Options 2 and 3, in transient systems, an adult wishing Alternative 
Water might not readily find it, as there would be no requirement to 
have it available, except for infants. The Agency is requesting comment 
on whether this need for assertive action would be appropriate, or 
whether such a strategy is reasonable, given the unique aspects of 
sulfate.
    Option 2 is based on the premise that diarrhea is not an adverse 
effect in adults. Until now, the Agency has considered some effects as 
adverse which, by themselves, are not harmful, but are precursors of 
adverse effects. Examples are (a) developmental effects, such as an 
extra embryonic rib which is later resorbed; (b) benign tumors; (c) 
reduction in maternal weight gain, even with no observable fetal 
effect; and (d) marginal cholinesterase inhibition. In comparison to 
these effects, the long-term effects of sulfate ingestion appear to be 
nil, and acclimation occurs in a short period of time. The other 
effects mentioned are only detected with scientific measurement, while 
diarrhea or loose stools are readily observed by the person ingesting 
sulfate. EPA requests comment on whether transient bouts of diarrhea 
should be considered an adverse health effect or simply an 
inconvenience in adults.
    In addition, EPA requests comment on whether, given the available 
information, a conclusion can be made that experiencing transient bouts 
of diarrhea resulting from ingestion of sulfate in drinking water is 
not an adverse effect in any segment of the population (adults or 
infants) within the meaning of the Safe Drinking Water Act.
    EPA also recognizes that the provisions of this regulation are more 
difficult to enforce than central treatment. Indeed, it is for similar 
reasons that EPA has always prohibited Alternative Water as a means of 
compliance. While PWSs already have the legal option to use a POE 
device to comply with any MCL if certain requirements are followed, the 
requirements for using bottled water or POU devices have been 
applicable only to temporary situations to prevent unreasonable risk to 
health. Adoption of any of the proposed options would also mean that 
individuals in the target population would drink bottled water on a 
temporary basis. However, the extent to which bottled water quality 
(i.e., compliance with all MCLs) can be assured varies from State to 
State. The Food and Drug Administration (FDA), which is responsible for 
overseeing bottled water quality, is continuing to adopt standards 
which ensure truthful labeling. However, production and sales of 
bottled water have increased dramatically in recent years, and FDA does 
not have a complete inventory of domestic bottled water plants. FDA 
inspects the known plants, on average, every three to four years, or 
more frequently if problems arise (GAO, 1992). A few States have 
stricter standards than FDA (NY, CA, PA, CT) and require all bottled 
water plants to register with the State and conform to State 
requirements.
    Similarly, POU devices are not subject to EPA certification. Since 
the proposed rule gives the States full authority to decide whether or 
not an alternative option would be allowed, each State would presumably 
base its decision on the extent to which it believes implementation is 
practicable. EPA requests comment on whether it is appropriate to allow 
use of bottled water and POU devices for sulfate MCL compliance.
    f. Option 4. Because the proposed option (1) and its variations (2) 
and (3) represent a significant change in regulatory approach, and in 
order to fully consider the issues raised, EPA considered another, more 
conventional option. Option 4 was considered in the event EPA 
determines that Alternative Water may not be as effective as central 
treatment in enabling small systems to comply with the sulfate MCL. 
Option 4 would not directly allow the use of Alternative Water as a 
means of compliance with the MCL.
    In Option 4, systems would need to obtain a variance from the 
sulfate MCL under the provisions of SDWA section 1415. As a condition 
of receiving a variance, systems would be required to provide 
Alternative Water to their target populations, just as in Option 1. 
Therefore, the relief under Option 4 would be similar to the relief 
under Option 1 but would be provided through a different statutory 
mechanism.
    In Option 4, central treatment would be designated as section 1412 
BAT. Central treatment would be considered economically feasible 
despite the financial difficulties presented to small systems, because 
the SDWA legislative history indicates Congress' desire that economic 
feasibility be determined by reference to large metropolitan water 
systems.
    Section 1415 (and corresponding State laws) provide that systems 
may obtain a variance only after they have applied the designated BAT 
technology. However, section 1415 also states that the EPA 
Administrator may vary the technologies identified as BAT for purposes 
of section 1415 variances ``depending on the number of persons served 
by the system or for other physical conditions related to engineering 
feasibility and costs of compliance with [MCLs] as considered 
appropriate by the Administrator.'' As a key component of Option 4, EPA 
would designate Alternative Water along with central treatment as BAT 
for purposes of section 1415 variances only. A PWS that is granted a 
variance would also be required to meet all of the requirements of 
Option 1 for public education/notification and provision of Alternative 
Water.
    Alternative Water would be designated as a section 1415 BAT because 
of the special need to provide bottled water which complies with EPA 
MCLs only to targeted populations for a limited time, which represents 
a special ``physical condition related to engineering feasibility'' 
under section 1415. To protect public health from the adverse effects 
of sulfate, it is necessary to protect only these specific 
subpopulations (infants, travelers, and new residents). It is 
technically infeasible to direct treated water only to those households 
containing these subpopulations, particularly when various households 
contain sensitive subpopulations at different times. However, it is 
technically feasible to direct public education and notification and 
Alternative Water only to those homes which require it. To treat water 
going to households with sensitive subpopulations would require a PWS 
to treat all water. The cost of providing treated water to everyone 
could be much higher than the PWS would otherwise have to incur.
    Option 4 would require administrative involvement by the State in 
reviewing variance applications. The additional administrative burden 
is a clear disadvantage of this option, especially because many State 
agencies administering the drinking water program currently have 
significant funding and resource problems. On the other hand, a scheme 
based on individually granted variances might be considered more 
desirable in that each PWS would need to justify to the State its 
individual plan for providing Alternative Water.
    States may also choose to grant variances in a block to many PWSs 
at a time, thus reducing their own administrative burden. However, the 
burden would remain on each system to make an application and present 
the details of its program to the State.
    For the reasons stated above with respect to Option 1, EPA has 
decided not to limit the availability of variances based on Alternative 
Water under Option 4 to smaller systems. The public education/
notification requirements discussed under Option 1 would apply to those 
systems receiving a variance under Option 4.
    Making relief available to small systems only through variances 
presents some additional statutory constraints compared to Option 1. 
First, variances are only available at the discretion of the State. The 
State is free not to grant variances or to issue them under more 
stringent conditions than set by EPA. For sulfate, based on the prior 
State comments and input, States are seeking flexibility and relief for 
small systems and, therefore, might generally be expected not to be 
more stringent on variances than EPA. On the other hand, it is unclear 
whether States will be dissuaded from providing many variances by the 
administrative burdens presented by Option 4.
    Second, under section 1415, variances are available only where the 
State finds that they will not result in an unreasonable risk to health 
(``URTH''). However, EPA does not believe that this constraint will 
present any problems since, as a condition of receiving the variance, 
PWSs will be required to supply Alternative Water that complies with 
the sulfate MCL.
    Third, section 1415 requires the State to prescribe with the 
variance a schedule for compliance with the MCL. In this case, by 
providing Alternative Water to qualify for the variance, the PWS would 
in fact be supplying water that meets the MCL. Therefore, EPA believes 
it is not necessary or appropriate to prescribe any further schedules 
for achieving compliance with the sulfate MCL.
    Finally, EPA also notes that SDWA section 1415 provides for 
variances where a system cannot meet the MCL because of characteristics 
of the raw water source. Here, the raw water source is not the issue; 
application of Alternative Water as section 1415 BAT would achieve the 
MCL but would be considered not as effective as central treatment in 
ensuring a consistent and reliable supply of water at the MCL. EPA 
nevertheless believes that Option 4 is consistent with the purposes and 
intent of SDWA section 1415, but requests comment on this issue.
    As an additional option, EPA considered whether relief to small 
systems could be provided through exemptions under SDWA section 1416. 
This does not appear to be a viable approach, however. Unlike section 
1415, section 1416 does not authorize EPA to vary its designation of 
BAT for purposes of exemptions. Instead, to qualify for indefinite 
exemptions, section 1415 envisions that small systems will be 
continuously working toward obtaining the financing necessary to 
install the BAT technologies identified under section 1412 (i.e., 
central treatment). Therefore, exemptions do not appear to be an 
appropriate mechanism for providing relief from the sulfate MCL to 
small systems. EPA solicits comment on whether exemptions do provide a 
mechanism for relief.
    g. Additional option. The Agency requests comment on the 
feasibility and appropriateness of the Options discussed above. The 
Agency is also considering an additional option, namely the traditional 
approach of simply relying on central treatment as BAT for all systems, 
with no special provisions for relief for small systems. The advantages 
to central treatment are that it is the easiest approach to enforce, 
and it is consistent with the Agency's regulatory approach for other 
contaminants. The disadvantages are that it is costly and would not 
provide flexibility or relief for small systems. In particular, under 
this option, drinking water that meets the sulfate MCL would need to be 
provided to all consumers even though only a small percentage of the 
population would experience adverse health effects from ingesting 
sulfate. Also, the Agency has concerns that this option would not be 
economically feasible for small systems, as discussed in section IV 
below. Accordingly, this option is not being offered as the preferred 
option in today's notice, but EPA is still considering it, and it has 
the potential to be adopted in the final rule. This option would be 
adopted, for example, if it appears that the other options would be 
inadequate to assure a supply of drinking water that dependably 
complies with the sulfate MCL (see Sec. 1401(1)(D) because members of 
the target population would fail to take appropriate action to protect 
themselves from an acute but temporary adverse health effect. The total 
national cost of this option would be identical to that for Option 4 
($147 million, see Table 8), since the economic analysis assumed that 
all systems would choose central treatment under Option 4. Similarly, 
the household cost for this option would be identical to those for 
Option 4 (Table 9). The Agency requests comment on whether this option, 
which would effectively limit methods of compliance to central 
treatment, should be adopted.
5. Compliance Monitoring Requirements
    a. Introduction. The proposed compliance monitoring requirements 
for sulfate would apply to all systems (community, non-transient non-
community, and transient non-community water systems).
    The occurrence of sulfate in drinking water may be predictable 
based on several factors including geological conditions, use patterns 
(e.g., pesticides), presence of industrial activity in the area, and 
type of source or historic record.
    PWSs would need to monitor for sulfate in accordance with EPA's 
Standard Monitoring Framework (SMF), published Jan. 30, 1991 (56 FR 
3564). Monitoring is done for three, three-year compliance periods in a 
nine-year cycle. The Phase II regulations established a nine-year cycle 
for those contaminants in that Federal Register notice. By agreement 
between States and EPA at a Denver work group meeting in 1992, 
subsequent rules will begin their individual nine-year cycles in the 
first January after the effective date (18 months after promulgation).
    The monitoring requirements described in the next section are 
proposed to apply to systems which exceed the MCL and are authorized by 
the State to select the preferred option (Option 1) to achieve 
compliance with the sulfate MCL. For systems which select central 
treatment, or which do not exceed the MCL, the SMF is proposed to 
apply. If either Option 2 or Option 3 becomes the final regulation for 
sulfate and the State allows that method of compliance, the monitoring 
requirements described for Option 1 regarding Alternative Water and the 
reporting/record keeping requirements for public notification would 
apply for systems exceeding the sulfate MCL. Initial monitoring to 
determine MCL exceedence would be required of all systems, that is, 
community, transient and non-transient, non-community systems.
    b. Proposed monitoring requirements for sulfate. The monitoring 
requirements for those systems selecting Option 1, with State 
authorization, would be as follows, and are consistent with the 
provisions of Sec. 142.62 (g) and (h).
    (1) Bottled water.
    There are regulations in effect (Sec. 142.62) which state that a 
PWS can be required or permitted by the State to supply its customers 
with bottled water as a condition for receiving a variance or 
exemption. These regulations indicate that the State shall require and 
approve a monitoring program for bottled water and that the PWS shall 
develop and put in place a monitoring program that provides reasonable 
assurances that the bottled water meets all MCLs. These same monitoring 
requirements are proposed to apply here. The PWS monitors a 
representative sample of the bottled water for all contaminants 
regulated under Secs. 141.61 (a) and (c) and 141.62 during the first 
three-month period that it supplies the bottled water to the public, 
and annually thereafter. Results of the monitoring are provided to the 
State annually.
    The State, in lieu of the above requirements, could accept 
certification from the bottled water company that the bottled water 
supplied has come from an approved source as defined in 21 CFR 
129.3(a); and that the bottled water company has conducted monitoring 
in accordance with 21 CFR 129.80(g) (1) through (3); and that the 
bottled water does not exceed any EPA MCLs. The PWS would have to 
provide certification to the State the first quarter after it supplies 
bottled water and annually thereafter. At the State's option a PWS may 
satisfy the requirements of this subsection by citing an approved 
monitoring program which is already in place in another State.
    The existing regulations regarding interim use of bottled water to 
avoid an unreasonable risk to health state that the PWS is fully 
responsible for the provision of sufficient quantities of bottled water 
to every customer via door-to-door delivery. The Option being proposed 
today (Option 1) would similarly require door-to-door delivery by the 
PWS to persons in the target population when the sulfate MCL is 
exceeded. EPA requests comment on whether this door-to-door delivery 
requirement is appropriate for the sulfate rulemaking, or whether the 
requirements should be more flexible. For example, several possible 
means of delivery might be allowed. Distribution points could be 
authorized to stock and supply bottled water to the target population, 
with coupons issued to consumers in the target population redeemable at 
the distribution point. PWSs supplying bottled water to households 
would deliver that water upon request and free of charge, except as 
discussed under III.B.4.c. above. EPA requests comment on the degree of 
flexibility needed in the mechanism for delivery of bottled water that 
meets the sulfate MCL.
    (2) POU/POE devices.
    The existing regulations for variance and exemption conditions 
(Sec. 142.62) also describe the requirements for allowing a PWS to use 
POU or POE devices. These regulations state that it is the 
responsibility of the PWS to operate and maintain the POU and/or POE 
treatment system. Before POU or POE devices are installed, the PWS 
obtains the primacy agent's approval of a monitoring plan which ensures 
that the devices provide health protection to the target population 
equivalent to that provided by central treatment. The PWS must apply 
effective technology under a State-approved plan. The microbiological 
safety of the water must be maintained at all times. The State must 
require certification of adequate performance, field testing, and if 
not included in the certification process, an engineering design review 
of the POU/POE devices. Under Sec. 142.62(h), the design and 
application of the POU/POE devices must consider the potential for 
increasing concentrations of heterotrophic bacteria in water treated 
with activated carbon. The State must be assured that buildings 
connected to the system have sufficient POU or POE devices that are 
properly installed, maintained, and monitored such that all consumers 
will be protected.
    The existing regulations described above would be applied in both 
Options 1 and 4. EPA assumes that only Options 1 and 4 would entail the 
use of POU/POE devices, since in Options 2 and 3, bottled water would 
likely be more cost-effective, given the reduced target population. The 
Agency seeks comment on whether all of these existing requirements 
should be proposed in the case of sulfate MCL exceedence, or whether 
more flexible requirements would be appropriate. For example, if 
recordkeeping could demonstrate that an effective maintenance program 
was in place to ensure the proper functioning of the treatment 
equipment and compliance with the MCL, some reduction in monitoring 
might be foreseen. The efficiency or longevity of certain types of POU 
or POE devices might also be considered.
    (3) Effective Dates for Initial Monitoring.
    Initial monitoring for all systems would begin in the first January 
after the effective date of the rule. EPA's issuance of the final 
sulfate rule is scheduled for May 1996. The effective date will be 18 
months after the promulgation of the final rule, or November of 1997. 
If this schedule is maintained, the initial monitoring for sulfate 
would begin in January 1998 for all systems.
    (4) Sampling Location.
    Under the proposed regulation, both ground water and surface water 
systems would take a minimum of one sample at every entry point to the 
distribution system which is representative of each well or source 
after treatment. The number of samples a system must take will be 
determined by the number of entry points. This will make it easier to 
pinpoint possible contaminated sources (wells) within a system. In both 
surface and ground water systems, the system shall take each sample at 
the same sampling point unless conditions make another sampling point 
more representative of each source or treatment plant.
    (5) Monitoring Frequency.
    Surface water systems would be required to monitor annually and 
ground water systems would sample every three years. Systems which 
comply by Option 1 would not be required to continue monitoring the 
water in the distribution system for sulfate. That water may continue 
to exceed the sulfate MCL, but the PWS would be in compliance by 
providing Alternative Water and public notification to target 
populations. However, the water would still have to be monitored for 
and meet MCLs for other contaminants.
    (6) Public Notice Requirements.
    EPA proposes that PWSs who use central treatment and who are 
nevertheless not in compliance with the sulfate MCL would be subject to 
the public notification requirements in Sec. 141.32. However, the 
Agency recognizes that having different public education/notification 
requirements for those systems choosing central treatment and those 
choosing Option 1 may create confusion, and seeks comment on this 
issue.
    For PWSs authorized by the State to use whichever option (1 through 
4) is promulgated in the final sulfate rule, public notification 
requirements are proposed to be those described in section III.B.4.b.3 
of this Notice.
    c. State Implementation. The Act provides that States may assume 
primary implementation and enforcement responsibilities for the PWS 
program (primacy). 40 CFR part 142 contains EPA's primacy regulations. 
In States or tribal governments where EPA has direct implementation, 
resource constraints make it unlikely that the Agency would offer the 
alternative options (1 through 4, whichever is promulgated) to systems. 
EPA Regional Offices will, however, have the discretion to consider 
particular circumstances in their decision about whether or not to 
offer and implement the alternative option. The Agency assumes that 
most States with primacy would offer the alternative option, but 
requests comment on this issue.
    Fifty-five out of 57 jurisdictions have applied for and received 
primacy under the Act. To implement the federal regulations for 
drinking water contaminants, States must have legal authorities which 
are at least as stringent as the federal regulations. To update their 
programs, States must comply with the requirements in 40 CFR 142.12 on 
revising approved primacy programs. This proposal describes the 
regulations and other procedures and policies States would need to 
adopt or have in place to implement the new regulations for sulfate.
    Under this proposal, States would be required to adopt the 
following requirements: Modifications to Sec. 141.23, Inorganic 
Chemical Sampling and Analytical Requirements, Sec. 141.32, Public 
Notification Requirements (i.e., mandatory health effects language to 
be included in public notification or violations), and Sec. 141.62(b), 
Maximum Contaminant Levels for Inorganic Contaminants, where sulfate 
has been added to the list.
    In addition to adopting drinking water provisions no less stringent 
than the federal regulations listed above, EPA is proposing to allow 
States to adopt certain requirements related to this regulation in 
order to have their program revision application approved by EPA. This 
rule proposes to provide flexibility to the State with regard to 
implementation of the monitoring requirements for sulfate depending on 
whether a system chooses central treatment or the alternative method of 
compliance promulgated in the final rule. In all cases, States would 
decide and inform PWSs as to whether the alternative method of 
compliance (referred to as Option 1 for simplicity) promulgated in the 
final sulfate rule will be allowed. Specifically, States would be 
authorized to offer Option 1 as a means of compliance to PWSs who 
exceed the sulfate MCL. Under Option 1, the State would need to approve 
the monitoring plan of a PWS that chooses the Alternative Water and 
public education/notification as a means of compliance. The 
requirements would be as follows:
    (1) State Primacy Requirements.
    To ensure that the State program includes all the elements 
necessary for an effective and enforceable program, the State's request 
for approval must include a plan that each system monitor for sulfate 
by the end of each compliance period. If the State is planning to 
authorize PWSs to use Option 1, it would need to submit the text of 
State laws requiring the Alternative Water and public notification/
education program, and a description of the State's plan to oversee 
compliance of the program. States planning to issue monitoring waivers 
would do so according to the requirements of Sec. 142.16.
    (2) State Recordkeeping Requirements.
    The State shall keep a record of PWSs choosing to use Option 1 to 
comply. If the State has authorized Option 1, PWSs would be required to 
notify the State within 30 days of reporting a sulfate MCL exceedence, 
of its decision on whether to use Option 1 or other means of achieving 
compliance.
    (3) State Reporting Requirements.
    The quarterly report shall include all systems that have violated 
the sulfate MCL, and those which the State has authorized to use Option 
1.
    d. Variances and Exemptions. Option 4 offers relief to small 
systems in the form of an alternative to centralized treatment. If a 
system in violation of the sulfate MCL chooses centralized treatment 
but for some reason cannot achieve compliance, the system would apply 
to the Primacy Agent for a variance, and the conditions of the variance 
would be the same elements described for Option 1.
(1) Variances
    Under section 1415(a)(1)(A) of the SDWA, EPA or a State with 
primacy may grant variances from MCLs to those public water systems 
that cannot comply with the MCLs because of characteristics of their 
water sources. At the time a variance is granted, the State must 
prescribe a compliance schedule and may require the system to implement 
additional control measures. The SDWA requires that variances may only 
be granted to those systems that have installed BAT (as identified by 
EPA). However, in limited situations a system may receive a variance if 
it demonstrates that the BAT would only achieve a de minimis reduction 
in contamination (see Sec. 142.62(d)). Before EPA or a State issues a 
variance, it must find that the variance will not result in an 
unreasonable risk to health (URTH). In general, the URTH level would 
reflect acute and subchronic toxicity for short-term exposures and high 
carcinogenic risks for long-term exposures. For sulfate EPA's guidance 
regarding what is an URTH level is set at the MCL because sulfate has 
an acute adverse health effect. For the sulfate variance, if the PWS 
provides public education/notification and Alternative Water, EPA 
believes that the State should be able to conclude that the PWS will 
not be considered to exceed an URTH because those actions are 
considered protective of public health.
    Under section 1413(a)(4) of the Act, States with primacy that 
choose to issue variances must do so under conditions and in a manner 
that is no less stringent than EPA allows under section 1415.
    The Act permits EPA to vary the BAT established under section 1415 
from that established under section 1412 based on a number of findings 
such as system size, physical conditions related to engineering 
feasibility, and the cost of compliance. Paragraph 142.62 of this 
proposed rule lists the BAT that EPA has specified under section 1415 
of the Act for the purposes of issuing variances. The variance BAT is 
Alternative Water and public education/notification.
(2) Exemptions
    Under section 1416(a), a State or EPA may grant an exemption 
extending deadlines for compliance with a treatment technique or MCL if 
it finds that:
    (a) Due to compelling factors (which may include economic factors), 
the PWS is unable to comply with the requirement;
    (b) The exemption will not result in an URTH; and
    (c) The system was in operation on the effective date of the NPDWR, 
or, for a system not in operation on that date, that no reasonable 
alternative source of drinking water is available to the new system.
    In determining whether to grant an exemption, EPA expects the State 
to determine whether the facility could be consolidated with another 
system or whether an alternative source could be developed. Another 
compelling factor is the affordability of the required treatments. It 
is possible that very small systems may not be able to consolidate or 
find a low-cost treatment. EPA's analysis of cost for the proposed 
sulfate rule shows that, for very small systems, the cost is lower to 
provide public education/notification, and Alternative Water than to 
provide central treatment. Thus, EPA believes this alternative BAT is 
affordable for these systems.
    As discussed above, granting exemptions under SDWA section 1416 
does not appear to be a viable approach to providing relief from the 
sulfate MCL for smaller systems. Unlike section 1415 for variances, 
section 1416 does not authorize EPA to vary its designation of BAT for 
purposes of exemptions.

IV. Economic Analysis

A. Executive Order 12866

    Under Executive Order 12866 (58 FR 51735 (October 4, 1993)), the 
Agency must determine whether the regulatory action is ``significant'' 
and therefore subject to OMB review and the requirements of the 
Executive Order. The Order defines ``significant regulatory action'' as 
one that is likely to result in a rule that may:
    (1) Have an annual effect on the economy of $100 million or more or 
adversely affect in a material way the economy, a sector of the 
economy, productivity, competition, jobs, the environment, public 
health or safety, or State, local, or tribal governments or 
communities;
    (2) Create a serious inconsistency or otherwise interfere with an 
action taken or planned by another agency;
    (3) Materially alter the budgetary impact on entitlements, grants, 
user fees, or loan programs or the rights and obligations of recipients 
thereof; or
    (4) Raise novel legal or policy issues arising out of legal 
mandates, the President's priorities, or the principles set forth in 
the Executive Order.
    Pursuant to the terms of Executive Order 12866, it has been 
determined that this rule is a ``significant regulatory action'' 
because it proposes a means of MCL compliance that is unique in its 
attempt to limit protection only to the affected populations. As such, 
this action was submitted to OMB for review. Changes made in response 
to OMB suggestions or recommendations will be documented in the public 
record.
    EPA prepared a Regulatory Impact Analysis (RIA) for this rule, 
titled the Regulatory Impact Analysis of Sulfate (August 30, 1994). The 
analysis used the following data, where available, for sulfate:
     Occurrence data to determine the number of systems 
exceeding the MCL;
     Treatment and waste disposal cost data and corresponding 
selection probabilities to estimate the system level and aggregate 
costs of achieving the proposed MCL; and
     Monitoring costs to estimate aggregate costs of the 
monitoring requirements.
    Occurrence data adequate to determine the number of systems 
exceeding the proposed MCL are available for sulfate. Table 7 indicates 
the number of systems in several system size categories expected to be 
out of compliance with the proposed MCL of 500 mg/L.

   Table 7.--Number of Systems Expected to Exceed 500 mg/L Sulfate\1\   
------------------------------------------------------------------------
                           Serving less    Serving less                 
    Water system type        than 500        than 3300     Total of all 
                              people          people          systems   
------------------------------------------------------------------------
Community Water Systems.        350(356)        500(477)        500(511)
Non-Transient, Non-                                                     
 Community Systems......        250(235)        250(264)        250(266)
Transient, Non-Community                                                
 Systems................      1150(1144)      1200(1187)      1200(1189)
Total Number of Systems.      1750(1735)      1950(1929)     1950(1966) 
------------------------------------------------------------------------
\1\Numbers are rounded; actual numbers are in parentheses.              

B. National Costs of the Proposed Rule

    Under Option 1, annualized national treatment and waste disposal 
cost is projected to total $86 million for the proposed MCL of 500 mg/
L, of which $8 million is estimated for monitoring and State 
implementation.
    With State authorization, the 1,500 systems assumed to choose 
public notification/education and Alternative Water account for $7 
million of the total, or about $5,000 per system. The Agency assumes 
that, despite the availability of Option 1, 25% of the systems 
(approximately 500) exceeding the sulfate MCL would choose either 
central treatment or regionalization, for a total cost of $71 million. 
Possible reasons for choosing central treatment would be to avoid a 
permanent requirement for public notification/Alternative Water 
provision and its associated administrative and logistical costs and 
activities, or to comply with other existing or future regulations on 
other contaminants. The difference in cost to large systems choosing 
central treatment rather than Option 1 is a factor of approximately 3 
to 5. EPA assumes that this additional cost would not dissuade large 
systems from choosing central treatment. For costing purposes, it was 
assumed that all transient systems not choosing central treatment would 
install a POE device, and all CWS and NTNC systems not choosing central 
treatment would use bottled water or POU devices. In reality, the 
Agency recognizes that there would be a mixture of choices among system 
types, and that the choice of a POE by a small system constitutes 
``central treatment'' for that system, since all water is treated and 
the technology used for the POE would be a BAT technology such as RO. 
Small transient systems could legally choose a POE device under any of 
the proposed options, and since their cost cannot be counted under both 
centralized treatment and Option 1, their costs have been included 
under the heading ``non-centralized treatment''.
    Under Options 2 and 3, the total cost of the rule is approximately 
$16 million, which also includes $8 million for State implementation 
and monitoring costs. The implementation of Options 2/3 would be much 
less costly than Option 1, but would involve all 2,000 systems, 
compared to the 1,500 systems which would choose public notification/
education and Alternative Water in Option 1. Consequently, the cost of 
implementation would be $8 million rather than the $7 million for 
Option 1. The target population would be reduced to infants and the 
water allocated reduced to 1 liter per day. Although more infants would 
be included by large systems choosing this option, infants comprise 
less than 2% of the population at any given time. The difference in 
cost to large systems choosing central treatment rather than Options 2/
3 would be at least an order of magnitude. EPA assumes that this 
additional cost would dissuade large systems from choosing central 
treatment, and therefore that all systems would choose Option 1. 
Implementation of Options 2 and 3 would be identical, except for the 
content of the public education/notification.
    Under Option 4, the total national cost of the rule is $147 
million. For costing purposes, it was assumed that all systems would 
install central treatment, rather than request a variance. For some of 
the smallest systems, the central treatment installed consists of a POE 
device, which functions on the same principles as a treatment plant 
(e.g., reverse osmosis). Since some percentage of systems would, in 
reality, request a variance and comply by public notification/education 
and Alternative Water provision, the cost for Option 4 is somewhat of 
an overestimate. At the same time the cost for Option 4 is an accurate 
estimate of what the cost would be for central treatment for all 
affected systems.
    Under all options, approximately 2,000 systems, most serving 
populations less than 500, are expected to exceed the sulfate MCL.
1. Assumptions Used To Estimate Costs
    For each system size category, for both ground and surface water 
systems, the projected number of systems with contamination above the 
sulfate proposed MCL was determined from the occurrence data. The 
number of systems exceeding the MCL was then merged with a compliance 
decision matrix, which gave the relative likelihood that a given system 
would choose various treatment, compliance and waste disposal options.
    For systems choosing central treatment, the resulting estimates 
were then multiplied by the unit engineering costs, which include both 
capital and O&M costs. Although pre-treatment costs were included in 
the estimates, the operation of reverse osmosis by some systems with 
very high influent sulfate levels may contribute to the need for 
additional post-treatment corrosion control to comply with the lead and 
copper rule. This would likely affect only systems with influent 
sulfate concentrations above 750 mg/L because more than one-third of 
the influent stream would be treated. These costs would be added to the 
costs of the BAT, but would not affect EPA's conclusions on 
affordability because they would be insignificant compared to the 
overall costs of the central treatment technology.
    For the purposes of cost estimation, the Agency assumed that the 
cost of either POU or POE is the same. Each system is assumed to 
install POE, since the cost of one POE is generally less than the cost 
of multiple POU units. For example, in a gas station, a POU unit would 
be needed at the men's restroom, the women's restroom and the water 
fountain in the public area. In this scenario, it might be cost-
effective to install one POE unit versus three POU devices. Several 
sources were used to estimate the capital and O&M costs for POU/POE 
units, including (1) ``Point-Of-Use Treatment of Drinking Water in San 
Ysidro, New Mexico;'' March, 1990; (2) National Network for 
Environmental Management Studies Research Report on Affordable Drinking 
Water Treatment for PWSs Contaminated by Excess Levels of Natural 
Fluoride;'' December, 1991; and (3) ``Very Small Systems Best Available 
Technology Document;'' First Draft; September, 1993. The calculations 
included some of the following assumptions:
    (1) Laboratory costs including four bacteriological analyses and 
two sulfate analyses per year.
    (2) The replacement frequency for both the particulate filter and 
the carbon post filter is assumed to be twice per year.
    (3) The purchase price for the POU devices ranges from $329 to $665 
depending on the number purchased at one time.
    (4) The cost for installation is assumed to be $79.
    (5) The cost for a one year maintenance service contract is assumed 
to be $508 per unit.
    Bottled water costs are based on data provided by the International 
Bottled Water Association. The cost includes cost of water, delivery, 
and labor. Water is estimated at $1.06 per gallon. People are assumed 
to consume 0.53 gallons per day. The Agency estimated 1 delivery per 
week with a round trip distance of 25 miles costing $0.28 cents per 
mile. The Agency also estimated one hour for each delivery at a labor 
rate of $14.70 per hour. For Options 2 and 3, where bottled water is 
provided only to infants, the water allocation is one liter per day.
    The Agency used Federal Reporting Data System (FRDS) data to 
determine how many people lived in an average system in each system 
size category. EPA used U.S. Census Bureau population and fertility 
data to estimate that 1.68% of the people were infants and 16.4% of the 
people were new residents. Recent census data put the average number of 
people per household at 2.6. The number of travelers needing 
Alternative Water was derived from information from the National Travel 
Data Center that there are approximately 1.27 billion person-trips made 
nationally each year. The number of traveling persons exposed is 
calculated by multiplying the estimated 250 million people served by 
all water systems with the probability that a traveler will visit a 
system with water containing sulfate levels exceeding the MCL. The 
probability that a traveler will visit such a system is calculated by 
dividing the resident population in a given system size category by the 
total resident population of all systems. This value is then multiplied 
by the number of person trips and divided by five (the number of person 
trips per year per traveler) to get the population of exposed travelers 
in that size category. The resulting estimate is that approximately 1 
million travelers are exposed to sulfate in excess of 500 mg/L.
    For the public education and notification requirements, the PWS is 
responsible for producing and delivering pamphlets according to EPA's 
public notification guidelines. The number of pamphlets needed per size 
category is calculated based on the population served by the PWS. 
Larger population centers will contain more medical facilities. For 
example, if size category 1 (25-100 people) serves 0.03% of the total 
population, it is also assumed to serve 0.03% of the nation's 6,634 
hospitals, 83,425 schools, and so on. The number of permanent signs per 
system is calculated by taking the number of hotels, campgrounds, 
interstate rest areas, rest rooms in restaurants and gas stations in 
the nation and multiplying by the percent of population served by each 
size category.
    The national annualized cost of the rule for the four options is 
shown in Table 8.

   Table 8.--National Annual Sulfate Costs for Options 1-4 (Dollars in  
                                Millions)                               
------------------------------------------------------------------------
                                  Option 1     Options 2/3    Option 4  
------------------------------------------------------------------------
Central Treatment.............         $71    ............        $139  
Public Not./Ed./Alt. Water....           7            $8    ............
State Implementation..........           7             7             7  
Monitoring....................           0.5           0.5           0.5
                               -----------------------------------------
      Total...................          86            16           147  
------------------------------------------------------------------------

2. Costs to Households
    Table 9 illustrates estimated household costs for the options being 
considered. For costing purposes, it was assumed that all systems were 
community water systems, since transient systems do not have 
households. For Option 1, costs increase for systems serving 
populations greater than 3,300 due to the fact that most of those 
systems would choose central treatment. Costs level off and decrease 
for systems serving populations greater than 10,000 due to economies of 
scale.

       Table 9.--Average Annualized Costs for Households (Dollars In Millions) in Community Water Systems       
----------------------------------------------------------------------------------------------------------------
                   System size                    No. of systems     Option 1       Options 2/3      Option 4   
----------------------------------------------------------------------------------------------------------------
25-100..........................................            1244            $250            $145            $811
101-500.........................................             491             138              56             534
501-3.3K........................................             194             106              24             376
3.3K-10K........................................              26             287               4             287
10K-100K........................................              10             244               2             244
>100K...........................................               0              NA              NA             NA 
----------------------------------------------------------------------------------------------------------------
\1\NA--no systems that size affected by high-sulfate water.                                                     

    On the basis of these estimated costs, EPA concludes that the 
options being considered would be economically feasible, and requests 
comment on this conclusion.
3. Assumptions Used to Estimate Benefits
    The Agency made assumptions for estimating the benefits of diarrhea 
cases avoided which included affected population, costs of medical 
care, and value of days lost to care givers, business travelers and 
vacationers.
    It is estimated that approximately 1.2 million people will have 
reduced exposure to sulfates as a result of PWSs' compliance with the 
sulfate MCL. The low and high estimates of reduced population exposure, 
based on uncertainty in occurrence data, are 0.9 million and 1.7 
million people, respectively.
    Evaluating benefits is limited to estimating reduced population 
exposure because there are inadequate dose-response data to estimate 
cases of adverse health effects avoided. Consequently, potential 
benefits per case of diarrhea avoided are estimated rather than total 
benefits. Exposed population is usually calculated by multiplying the 
number of systems failing the MCL by the average population served by 
each system. A different approach was used for sulfate, since only 
unacclimated persons and infants are affected. The affected population 
is in areas served by systems with sulfate levels of 500 mg/L or more, 
and includes resident infants under one year of age, travellers, 
including infants, of all ages visiting the area, new residents and 
houseguests that stay with residents. Infants were assumed to accompany 
parents on pleasure trips but not on business trips. Sources of 
population data were the National Travel Data Center and the U.S. 
Census Bureau Current Population Reports and fertility statistics. The 
Agency used the 1991 census data for the number of infants born in a 
year. The number of persons exposed is calculated by multiplying the 
estimated 250 million people served by all water systems with the 
probability that the average traveler will visit a system with elevated 
sulfate levels. The Agency used the National Travel Data Center 
estimate of approximately 1.27 billion person-trips made nationally 
each year for travelers. The number of diarrhea cases avoided is based 
on the estimate of person-trips because each un-acclimatized individual 
is assumed to face multiple exposures to sulfate and potentially 
contract diarrhea more than once a year.
    This estimate of people exposed has uncertainty based on two 
variables: the number of systems with elevated sulfate levels, and the 
data used to model the traveling population. The best estimate of the 
number of travellers and resident infants with reduced exposure to 
sulfate at an MCL of 500 mg/L is 1.2 million people (including 27,000 
infants). A logistic response function was used to characterize the 
statistical relationship between sulfate levels in drinking water and 
the probability of an exposed individual experiencing a laxative 
effect. One weakness of this approach is that it assumes that 
consumption of either sodium sulfate or magnesium sulfate results in 
equivalent laxative effects. It has been reported that magnesium 
sulfate is a better purgative than sodium sulfate.
    Uncertainty is also associated with the lack of toxicological data 
on the relationship between various sulfate levels and the resulting 
laxative effect. There are insufficient data to plot a dose-response 
function. As a result, the Agency is limiting its estimate of benefits 
to an individual case basis.
    The assumptions made in estimating benefits on a case by case basis 
are shown in Table 10. The value of an outpatient case in Table 10 is 
between $218-$273. For example, the value of a case of diarrhea in a 
resident infant who is not hospitalized would be $55+$11 for the doctor 
and medication, plus 8 hours of the care giver's time ($19 x 8=$152), 
since it is assumed the caretaker would miss work. The total value for 
the case is $66+$152=$218. An additional $55 would be added in the case 
of a traveling infant for hotel and travel expenses lost. The range 
accounts for the difference between residents and travelers. The infant 
hospitalization cases cost between $3,608 and $3,828 per case. The 
Agency is requesting comment on the assumptions used in the analysis of 
the benefits of the proposed rule.

                               Table 10.--Assumptions Made in Estimating Benefits                               
----------------------------------------------------------------------------------------------------------------
                                                     Resident       Travelling      Travelling     New resident 
                                                      infants         infants         adults          adults    
----------------------------------------------------------------------------------------------------------------
Out-Patient Cases:                                                                                              
    Doctor Charges..............................             $55             $55             $55             $55
    Medication Charges..........................             $11             $11             $11             $11
    Days Lost Per Case..........................               1               1               1               1
    Value of Each Day Lost\1\...................            (NA)             $55             $55            (NA)
    Hours Lost Per Case.........................               8               8               8               8
    Value of Each Hour Lost.....................             $19             $19             $19             $19
    Value Per Case:.............................            $218            $273            $273            $218
Hospitalized Cases:\2\                                                                                          
    Number of Days..............................               4               4               0               0
    Hospital Cost Per Day.......................            $750            $750               0               0
    Value of Each Trip Day Lost\3\..............            (NA)             $55               0               0
    Hours Lost Per Case.........................              32              32               0               0
    Value of Each Hour Lost.....................             $19             $19               0               0
    Value Per Case..............................          $3,608          $3,828               0               0
----------------------------------------------------------------------------------------------------------------
\1\Out of pocket hotel and travel expenses, not applicable to infants or new residents, only to business        
  travelers.                                                                                                    
\2\NA--Older travellers are not hospitalized.                                                                   
\3\No value assigned to trip days lost for infants.                                                             

C. Comparison to Earlier Proposed Rule

    The 1990 proposed rule estimated the cost for central treatment to 
be $65 million (excluding monitoring costs). There were assumed to be 
1350 systems which would need to treat for sulfate. For this reproposal 
EPA updated the cost to $139 million (excluding State and monitoring 
costs). The increase in cost is due to: (1) The increase in projected 
number of systems that would exceed the sulfate MCL from 1350 to 1950, 
(2) change in the interest rate from 3% to 7%, and (3) updating for 
1991 dollars.
    Although the new occurrence information was taken primarily from 
the National Inorganics and Radionuclides Survey (NIRS), EPA 
complemented that information with sampling data from New York, Utah, 
South Dakota, North Dakota and New Jersey. Because of the new 
occurrence information, the number of systems has gone up from 1350 to 
1950. Another reason for the increase is EPA's modification, as a 
result of research for the upcoming regulation concerning the control 
of radionuclides in drinking water, of the number of treatment sites 
per ground water system. Ground water systems frequently contain more 
than one site requiring treatment because wells are typically not piped 
to a central source. EPA has incorporated this estimation method for 
all systems served by ground water.

D. Annual Burden to PWSS and States

    EPA estimates that the cost of sulfate regulation to State programs 
will be $7 million per year. Table 11 illustrates the 18-year average 
annual national burden hours, responses and costs to PWSs and States. 
Sulfate testing does not require special laboratory equipment. 
Therefore, it is assumed that laboratory expansion undertaken to 
implement the Phase II and Phase V regulations will largely satisfy the 
monitoring needs of this rule. On the other hand, EPA recognizes that 
States are likely to provide more technical assistance to systems than 
for an average contaminant because of the unique nature of Option 1. 
Total annual costs are estimated to be $10.6 million. The additional 
public reporting burden on PWSs for this collection of information is 
estimated to average 8.6 hours per response.

                     Table 11.--Annual Burden Hours                     
------------------------------------------------------------------------
                               PWSs           States           Total    
------------------------------------------------------------------------
Annual Burden (Hours)...          66,581         300,000         366,581
Annual Cost ($).........      $3,577,613      $7,000,000     $10,577,613
Annual Responses........          42,615              57          42,672
------------------------------------------------------------------------
Source: Sulfate ICR, August 31, 1994.                                   

V. Summary of Selected Issues

    EPA is soliciting public comment and scientific information on all 
issues presented in or pertaining to this proposed sulfate regulation. 
In particular, EPA requests comments on the following:
    (1) Is there a correlation between sulfate concentrations, 
palatability and consumption of high-sulfate water by the public?
    (2) Are there new data in support of or opposing the reproposed 
MCLG of 500 mg/L? Are there new data in support of a higher MCLG?
    (3) Are there data to support or refute the hypothesis that the 
decrease in available water resulting from sulfate ingestion may result 
in dehydration in adults or infants?
    (4) Are reverse osmosis, ion exchange and electrodialysis reversal 
appropriate technologies for sulfate removal?
    (5) Should a higher PQL of 30 mg/L be set in order to retain the 
colorimetric method of analysis?
    (6) Are the allotted time periods for provision of Alternative 
Water, i.e., 20 weeks for infants within the first year of life and 6 
weeks for new residents and travelers, appropriate and protective?
    (7) What should be the means of compliance for unmanned, remote 
campgrounds in the national parks system, particularly in regard to the 
provision of Alternative Water?
    (8) What types of Alternative Water would be likely to be chosen by 
public water systems of various types and sizes?
    (9) Are the compliance requirements, that is, Alternative Water and 
public notification, sufficiently protective of the sensitive 
population?
    (10) Should the target population be limited just to infants, or 
should there be different requirements for protecting infants and 
adults?
    (11) Are the proposed options consistent with the purposes and 
intent of SDWA, and are they feasible?
    (12) Is a provision to allow the water supply to exceed the sulfate 
MCL while relying on public notification and self-protection 
appropriate under SDWA?
    (13) Is the need for assertive action on the part of the public for 
self-protection appropriate?
    (14) Should temporary diarrhea be considered an adverse health 
effect in adults or infants?
    (15) Would exemptions provide a mechanism for relief to smaller 
systems?
    (16) Should compliance be limited to central treatment?
    (17) Is it appropriate under SDWA to allow the use of bottled water 
and POU devices for sulfate MCL compliance?
    (18) What degree of flexibility is appropriate in the bottled water 
monitoring requirements and delivery mechanism?
    (19) In Options 1 and 4, should all the existing regulations 
regarding use of POU and POE devices be imposed in the case of sulfate 
levels higher than the MCL, or are more flexible requirements 
appropriate?
    (20) Should the generic public notice requirements applicable to 
variances under Sec. 141.32 apply under Option 4 to systems who choose 
central treatment, in lieu of the public notice requirements proposed 
in Option 1?
    (21) Are the assumptions used in the analysis of the costs and 
benefits of the proposed rule reasonable?
    (22) What flexibility is appropriate or practical in regard to the 
maintenance of POU/POE devices installed to comply with the sulfate 
MCL? What flexibility is appropriate regarding a reduction in 
monitoring if certain types of POU/POE devices were installed?
    (23) Would most States offer the alternative option to PWS as a 
means of compliance?

VI. Other Requirements

A. Regulatory Flexibility Analysis

    The Regulatory Flexibility Act (5 U.S.C. 601 et seq.) calls for the 
Agency to consider the potential impacts of proposed regulations on 
small businesses, organizations and government jurisdictions. If an 
analysis shows that regulations would have a significant impact on a 
substantial number (usually taken as at least 20 percent) of small 
entities, then a regulatory flexibility analysis (RFA) must be 
prepared. In an RFA, an agency examines ``any significant alternatives 
to the proposed rule which accomplish the stated objectives of 
applicable statutes and which minimize any significant economic impact 
of the proposed rule on small entities'' (Regulatory Flexibility Act 
section 603).
    Today's proposed regulation would affect less than 2,000, or one 
percent, of the total of 200,000 public water systems (including all 
community and non-community systems). Nevertheless, EPA's analysis 
shows that regulating sulfate through standard approaches that assume 
the need for central treatment would have significant economic impacts 
that would fall largely on smaller public water systems. Therefore, EPA 
has conducted a regulatory flexibility analysis by investigating 
alternative, less burdensome regulatory approaches for those small 
systems. From these investigations, EPA developed and is considering 
the innovative options for regulating sulfate described earlier in this 
notice. These innovative options accomplish the Regulatory Flexibility 
Act's goal of minimizing the impacts of this regulation on small public 
water systems while meeting the objectives of the Safe Drinking Water 
Act by ensuring that drinking water that meets the sulfate MCL will be 
provided to all persons within the target population.

B. Paperwork Reduction Act

    The information collection requirements in this proposed rule have 
been submitted for approval to the Office of Management and Budget 
(OMB) under the Paperwork Reduction Act (44 U.S.C. 3501 et seq.). An 
Information Collection Request (ICR) document has been prepared by 
EPA(ICR No. 270.34) and a copy may be obtained from Sandy Farmer, 
Information Policy Branch; EPA; 401 M Street, SW. (Mail Code 2136); 
Washington, DC 20460 or by calling (202) 260-2740.
    This collection of information has an estimated annual reporting 
and recordkeeping burden averaging 9.3 hours per respondent. These 
estimates include time for reviewing instructions, searching existing 
data sources, gathering and maintaining the data needed, and completing 
and reviewing the collection of information. National annual burden and 
cost estimates for PWSs and States are presented in Table 11.
    Send comments regarding the burden estimate or any other aspect of 
this collection of information, including suggestions for reducing this 
burden to Chief, Information Policy Branch; EPA; 401 M Street, SW. 
(Mail Code 2136); Washington, DC 20460; and to the Office of 
Information and Regulatory Affairs, Office of Management and Budget; 
Washington, DC 20503, marked ``Attention: Desk Officer for EPA''. The 
final rule will respond to any OMB or public comments on the 
information collection requirements contained in this proposal.

C. Enhancing the Intergovernmental Partnership

    Executive Order 12875, Enhancing Intergovernmental Partnerships 
explicitly requires Federal agencies to consult with State, local, and 
tribal entities in the development of rules and policies that will 
affect them. EPA has complied with the Order in proposing the sulfate 
rule in the following ways.
    First, the Agency met with interested parties, including 
representatives from four States, Region 8, and the Association of 
State Drinking Water Administrators in Denver, Colorado in November, 
1992.
    Secondly, the Agency plans to meet with the National Drinking Water 
Advisory Council (NDWAC), a group composed of representatives from 
State, local and tribal governments in addition to water suppliers and 
environmentalists.
    Thirdly, the Agency is developing generic contacts with State, 
Tribal and local fiscal and program officials which will enable various 
programs to consult with affected parties in a coordinated fashion. 
Identification of appropriate contacts was not accomplished in a time 
frame which enabled EPA's Office of Water to have extensive 
consultation with affected parties in compliance with the E.O. before 
proposal. However, a contact person has now been designated from ASDWA, 
and the Agency will be meeting with this designee and other interested 
State officials. EPA is committed to expanded dialogue and 
collaboration with State, Tribal and local governments. EPA will 
schedule a work group or public meeting to solicit comments of fiscal 
and program officials or State, Tribal and local governments. The 
intent of such a meeting is to allow for the maximum input from the 
regulated community for the drafting of the final rule. EPA will also 
send copies of this proposed rule to these governmental bodies, as well 
as to national and local associations (e.g., the Association of State 
Drinking Water Administrators, the National League of Cities, the 
National Association of Towns and Townships, the National Association 
of County Health Officers, etc.)

VII. References

    The following references are referred to in this notice and are 
included in the public docket together with other correspondence and 
information. The public docket is available as described at the 
beginning of this notice. All public comments received on the proposal 
are included in the public docket.

American Water Works Association (AWWA) Conference Proceedings (March 
1991): Suffolk Introduces Electrodialysis Reversal to Virginia. M. 
Thompson and M. Robinson.
Canadian Guidelines. Personal correspondence (August 23, 1991) from R. 
Tobin to C. Abernathy, citing Guidelines for Canadian Drinking Water 
Quality, 4th Edition (1989).
Chien, L., Robertson, H., Gerard, J.W. 1968. Infantile gastroenteritis 
due to water with high sulfate content. Can. Med. Assoc. J. 99:102-104
Federal Register. Vol. 54, No. 97. National Primary and Secondary 
Drinking Water Regulations; Proposed Rule (May 22, 1989) 22062-22160. 
(54 FR 22062)
Federal Register. Vol. 55, No.143. National Primary and Secondary 
Drinking Water Regulations; Synthetic Organic Chemicals and Inorganic 
Chemicals; Proposed Rule (July 25, 1990), 30370-30448. (55 FR 30370)
Federal Register. Vol. 57, No. 138. National Primary and Secondary 
Drinking Water Regulations; Synthetic Organic Chemicals and Inorganic 
Chemicals; Final Rule (July 17, 1992), 31776-31838. (57 FR 31776)
Federal Register. Vol. 58, No. 239. National Primary and Secondary 
Drinking Water Regulations; Proposed Rule. (December 15, 1993) (58 FR 
60622)
GAO, Food Safety and Quality, Limitations of FDA's Bottled Water Survey 
and Options for Better Oversight. GAO/RCED-92-87, February 1992.
Information Collection Request, August 31, 1994
Peterson, N.L. 1951. Sulfates in drinking water. Official Bulletin N.D. 
Water Sewage Works 18:11.
Moore, E.W. 1952. Physiological effects of the consumption of saline 
drinking water. A progress report to the 16th Meeting of the 
Subcommittee on Water Supply of the Committee on Sanitary Engineering 
and Environment, January, 1952. Washington, DC: National Academy of 
Sciences, Appendix B.
Regulatory Impact Analysis, August 31, 1994
Schild, H.O. Applied Pharmacology 12th Edition (1980) ``The Alimentary 
Canal'': 197-198. Churchill Livingstone, Inc.
U.S. EPA Comment/Response Document for Sulfate from Phase V
U.S. EPA Expert Panel Meeting Minutes, May 20, 1992.
U.S. EPA Early Involvement Meeting Minutes, Denver, CO, 1992
U.S. EPA Health Criteria Document for Sulfate, January 1992
U.S. EPA Lab Certification Manual Section
WHO, 1983. World Health Organization. Guidelines for drinking water 
quality--recommendations. Volume 1. Geneva, Switzerland: World Health 
Organization.

List of Subjects in 40 CFR Parts 141, 142 and 143

    Chemicals, Reporting and recordkeeping requirements, Water supply, 
Administrative practice and procedure.

    Dated: November 30, 1994.
Carol M. Browner,
Administrator.

    For the reasons set out in the preamble, 40 CFR parts 141, 142 and 
143 are proposed to be amended as follows:

PART 141--NATIONAL PRIMARY DRINKING WATER REGULATIONS

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

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


Sec. 141.23  Inorganic chemical sampling and analytical requirements.

    2. Section 141.23 is amended by revising the last sentence of the 
introductory text to read as follows:
    Transient, non-community water systems shall conduct monitoring to 
determine compliance with the nitrate, nitrite and sulfate maximum 
contaminant levels in Sec. 141.11 and Sec. 141.62 (as appropriate) in 
accordance with this section.
* * * * *


Sec. 141.23  [Amended]

    3. In Sec. 141.23(a)(4)(i), the table is amended by adding in 
alphabetical order an entry for sulfate to read as follows:
* * * * *
    (a) * * *
    (4) * * *
    (i) * * *

----------------------------------------------------------------------------------------------------------------
                                                                                                     Detection  
              Contaminant                  MCL (mg/l)                  Methodology                 limit (mg/l) 
----------------------------------------------------------------------------------------------------------------
                                                                                                                
                                                  * * * * * **                                                  
Sulfate................................             500  Colorimetry............................            3   
                                                         Gravimetry.............................            1   
                                                         Ion Chromatography.....................            0.02
----------------------------------------------------------------------------------------------------------------

* * * * *


Sec. 141.23  [Amended]

    4. In Sec. 141.23(c) introductory text, ``sulfate'' is added in 
alphabetical order to the list of contaminants.


Sec. 141.23  [Amended]

    5. In Sec. 141.23(d) introductory text, ``and sulfate'' is added 
after the word ``nitrate''.


Sec. 141.23  [Amended]

    6. In Sec. 141.23(f)(1), ``sulfate'' is added in alphabetical order 
to the list of contaminants.


Sec. 141.23  [Amended]

    7. In Sec. 141.23(i)(1) and Sec. 141.23(i)(2), ``sulfate'' is added 
in alphabetical order to the list of contaminants.


Sec. 141.23  [Amended]

    8. The table in Sec. 141.23(k)(1) is amended by adding an entry for 
``Sulfate'' in alphabetical order as follows:
* * * * *
    (k) * * *
    (l) * * *

----------------------------------------------------------------------------------------------------------------
   Contaminant      Methodology      EPA1512        ASTM\2\              SM\3\            USGS\4\       Other   
----------------------------------------------------------------------------------------------------------------
                                                                                                                
                                                  * * * * * **                                                  
Sulfate.........  Ion                 \8\300.0  D4327-91......  4110                    ...........  ...........
                   chromotography.                                                                              
                  Colorimetry....     \8\375.2  ..............  4500-SO4-C,D            ...........  ...........
                  Gravimetry.....  ...........  ..............  4500-SO4-F              ...........  ...........
----------------------------------------------------------------------------------------------------------------

* * * * *


Sec. 141.23  [Amended]

    9. In Sec. 141.23(k)(4), ``Sulfate'' is added in alphabetical order 
to the list of contaminants, and the table is amended as follows:
* * * * *
    (k) * * *
    (4) * * *

------------------------------------------------------------------------
 Contaminant      Preservative\1\            Container\2\        Time\3\
------------------------------------------------------------------------
                                                                        
                                  *****                                 
Sulfate.....  Cool, 4  deg.C.........  P or G.................   28 days
------------------------------------------------------------------------

* * * * *


Sec. 141.23  [Amended]

    10. In Sec. 141.23(k)(5), introductory text, ``sulfate'' is added 
in alphabetical order to the list of contaminants.


Sec. 141.23  [Amended]

    11. In Sec. 141.23(k)(5)(ii), the table is amended by adding an 
entry for sulfate as follows:
    (k) * * *
    (5) * * *
    (ii) * * *

------------------------------------------------------------------------
            Contaminant                        Acceptance limit         
------------------------------------------------------------------------
Sulfate............................  15% at  10  
                                      mg/l                              
------------------------------------------------------------------------

* * * * *


Sec. 141.23  [Amended]

    12. Section 141.23 is amended by adding paragraph (r) to read as 
follows:
* * * * *
    (r)(1) Compliance with the MCL for Sulfate. (i) PWSs subject to the 
sulfate MCL established under Sec. 141.62(b) shall demonstrate 
compliance with the sulfate MCL. If authorized by the State to do so, 
PWSs may choose to comply in one of the following two ways:
    (A) The PWS shall demonstrate compliance by achieving the MCL in 
samples taken at each entry point to the distribution system; or
    (B) The PWS shall demonstrate compliance by meeting the 
requirements of Secs. 141.23(r)(2) and (3) (program for providing 
Alternative Water to Target Populations and providing public 
notification and education). The requirements of Secs. 141.23(r)(2) and 
(3), taken together, are termed the ``Alternative Method of 
Compliance.'' However, the availability of the Alternative Method of 
Compliance is limited by paragraph (r)(1)(ii) of this section.
    (ii) The State has the option of whether or not to allow PWSs to 
demonstrate compliance through the Alternative Method of Compliance. 
Where the State has chosen not to allow the Alternative Method of 
Compliance, PWSs shall demonstrate compliance by achieving the MCL in 
samples taken at each entry point to the distribution system.
    (iii) Where EPA is the primacy agent, the Regional Administrator 
may authorize PWSs to demonstrate compliance through the Alternative 
Method of Compliance. In determining whether to authorize the use of 
the Alternative Method of Compliance, the Regional Administration in 
its sole discretion may consider the availability of regional 
resources, and whether it is reasonable and practical for the Regional 
Office to oversee implementation of the Alternative Method of 
Compliance. If the Regional Administrator authorizes the Alternative 
Method of Compliance, each PWS shall have the option to comply either 
by achieving the MCL in samples taken at each entry point to the 
distribution system or through the Alternative Method of Compliance.
    (iv) Until such time as notified by the State or Primacy Agency 
that the Alternative Method of Compliance will be authorized, PWSs 
shall be required to achieve the MCL at each entry point to the 
distribution system.
    (v) The general prohibition on the use of bottled water and point-
of-use devices in 40 CFR 141.101 shall not apply to PWSs that choose to 
achieve compliance with the MCL for sulfate by meeting the requirements 
of the Alternative Method of Compliance.
    (vi) A PWS must report failure to comply with a NPDWR to the State 
under the requirements of 40 CFR 141.31. Within 30 days of notifying 
the State of failure to comply with the sulfate MCL, the PWS shall 
notify the State as to which of the two methods of compliance, 
Sec. 141.23(r)(1)(i) (A) or (B), the PWS intends to use to return to 
compliance with the sulfate MCL.
    (2) Alternative Water Supplied to Target Populations.  The 
requirements of this subsection apply only to a PWS that has chosen to 
comply with the MCL for sulfate through the Alternative Method of 
Compliance instead of by achieving the MCL in samples taken at each 
entry point to the distribution system.
    (i) Definitions. (A) Alternative water: For purposes of this 
section, a PWS supplies Alternative Water when it supplies either 
bottled water or water that has been treated with a POU or POE device 
(as defined in Sec. 141.2).
    (B) Target population, for purposes of this section, means all 
infants, travelers and new residents within the PWS's service area, 
according to the following:
    (1) For the purposes of this rule, infant is defined as persons 
under the age of 12 months.
    (2) Transients means visitors from outside the service area, 
vacation travelers and business travelers.
    (3) New residents means persons who have resided in the service 
area for no more than six weeks.
    (ii) Community water systems shall maintain a record of all 
requests for Alternative Water. Records shall include the name and 
address of the person requesting the water, date of request, date of 
delivery requested, date of delivery and quantity of water delivered 
(or date of installation in the case of a POU/POE device). This record 
shall be maintained for five years from the time of recording.
    (iii) Community water systems shall supply Alternative Water in 
compliance with this subsection to the Target Population for the time 
periods described under paragraph (r)(2)(vii) of this section. 
Transient water systems and non-transient, non-community systems shall 
have alternative water available for infants, travelers, newcomers and 
visitors.
    (iv) Community water systems shall provide door-to-door delivery of 
the bottled water or installation of POU or POE devices upon request to 
customers who are within the Target Population. The PWS shall have the 
option of deciding whether to provide a customer with bottled water or 
POU/POE devices.
    (v) Bottled water requirements. (A) Quality. Bottled water provided 
by the PWS shall meet the requirements of Sec. 142.62 (g)(1) or (g)(2) 
of this chapter.
    (B) Quantity. Community water systems shall have bottled water 
available and delivered at the level of two liters per day for each 
person within the Target Population for whom bottled water is requested 
(unless the customer requests a lesser amount). Transient water systems 
and non-transient, non-community systems shall have sufficient bottled 
water to serve the transient population, unless POE or POU devices are 
installed.
    (C) Time of delivery. Community water systems shall deliver the 
bottled water within 24 hours of the request, or on the date requested, 
whichever is later.
    (vi) POU and POE device requirements. PWSs that choose POU or POE 
devices as a method of compliance shall meet the following 
requirements:
    (A) PWSs that choose POE devices as a method of compliance shall 
meet the requirements of Sec. 141.100 (a) through (d).
    (B) If the PWS decides to provide a POE/POU device and is unable to 
install such equipment within 24 hours of the request, or on the date 
requested, the PWS shall provide bottled water to the target population 
during the interim time period between the time of the request and the 
time of installation of the POU/POE device.
    (C) PWSs that choose POU devices as a method of compliance shall 
obtain the approval of a monitoring plan which ensures that the devices 
provide water that complies with the sulfate MCL. It is the 
responsibility of the public water system to operate and maintain the 
POU system. The microbiological safety of the water must be maintained 
at all times. The State shall require adequate certification of 
performance and a rigorous engineering design review. The design and 
application of the POU must consider the potential for increasing 
concentrations of heterotrophic bacteria in water treated with 
activated carbon.
    (D) The State must be assured that the POU and POE devices are 
properly installed, maintained and monitored.
    (vii) Period of delivery. The PWS shall provide Alternative Water 
for the following time periods:
    (A) Alternative Water shall be provided to each infant for the 
period requested, which may not exceed twenty weeks from the date of 
initial delivery. Alternative Water delivery shall be provided for the 
full twenty weeks if requested, even if the infant becomes one year of 
age during the delivery period.
    (B) Alternative Water shall be provided to each traveler and new 
resident for the period requested, not to exceed six weeks from the 
date of initial delivery.
    (3) Public Notification/Education Program. The requirements of this 
section apply only in States which have authorized the Alternative 
Method of Compliance. The requirements apply only to those PWSs in such 
States which have chosen to comply with the sulfate MCL through the 
Alternative Method of Compliance rather than by achieving the MCL in 
samples taken at each entry point to the distribution system. The PWS 
shall implement the public notification/education program described in 
this subsection in lieu of Sec. 141.32, and shall provide the State 
with copies of all public notification and education materials at the 
same time. There are four components to the program: Notices in bills, 
pamphlets, signs, and notices to the media. Transient systems (e.g., 
campgrounds and gas stations) and non-transient, non-community systems 
(e.g. schools, factories) shall be required to post signs in accordance 
with paragraphs (r)(3)(v) of this section, but shall not be required to 
comply with the requirements for notices in bills, notices to the 
media, or pamphlets in paragraphs (r)(3) (i)-(iv) and (vi) of this 
section. Community water systems which are non-transient systems shall 
comply with all four components set forth in paragraphs (r)(3) (i)-(vi) 
of this section, i.e., notices in bills, pamphlets, signs, and notices 
to the media.
    (i) Newspaper, mail, hand delivery, of notices. PWSs shall give 
notice by publication in a daily newspaper of general circulation in 
the area served by the system as soon as possible, but in no case later 
than 14 days after sulfate in excess of the MCL has been detected in 
the water. The notice shall be repeated at intervals of 6 months while 
the sulfate concentration of the water in the distribution system 
continues to exceed the MCL. If the area served by a public water 
system is not served by a daily newspaper of general circulation, 
notice shall instead be given by publication in a weekly newspaper of 
general circulation. The notice shall define and describe the 
geographic location served by the system. In communities where a 
significant portion of the population speaks a language other than 
English, the text shall be published in the appropriate language(s), in 
addition to English. A telephone number(s) and an office location for 
requesting Alternative Water delivery shall be provided. The notice 
shall be provided at least once every six months by mail delivery (by 
direct mail or with the water bill), or by hand delivery, not later 
than 45 days after the sulfate MCL has been exceeded.
    (ii) Text of the Notice. The PWS shall, within 60 days of confirmed 
detection of sulfate in the distribution system, insert notices in each 
customer's water utility bill containing the following mandatory 
paragraph on the water bill itself in large bold print.

    Warning: The water being supplied to you has high levels of 
sulfate which can cause diarrhea in people who are not used to it. 
If you have visitors in your home from outside the area, or if you 
are expecting a baby, please read the enclosed notice for further 
information.

    The notices included in the water utility bill and those provided 
to the media shall also contain the following mandatory language. Any 
additional information presented shall be consistent with the 
information in these paragraphs, and in plain English that can be 
understood by laypersons. In communities where a significant portion of 
the population speaks a language other than English, the text shall be 
published in the appropriate language(s), in addition to English. The 
text shall be as follows: ``Introduction. The United States 
Environmental Protection Agency (EPA), the [insert name of State 
primacy agency], and [insert name of water supplier] are concerned 
about sulfate in your drinking water. Sulfate salts are found naturally 
in soil and rock in certain areas of the country, including ours. With 
the exception of infants, residents of the area should be accustomed to 
the sulfate in our drinking water, and should not experience ill 
effects. However, people who are not accustomed to high levels of 
sulfate in their drinking water may experience diarrhea. Under Federal 
law, we are required to provide sensitive populations with alternative 
water until their bodies adapt to the sulfate concentrations in our 
water. This brochure explains the simple steps you can take to protect 
the sensitive populations: infants, visitors from outside the area, and 
new residents.

Health Effects of Sulfate

    Ingestion of sulfate in high concentrations is known to cause 
diarrhea. The greatest risk is to infants, for whom prolonged diarrhea 
can be dangerous. New residents and travelers may also experience 
diarrhea when they first drink water with high levels of sulfate. After 
approximately two weeks, adult's bodies become accustomed to the 
sulfate, and the diarrhea stops. Available studies have not shown any 
long-term or chronic adverse effects from consuming sulfate in drinking 
water. Boiling the water will not reduce the sulfate content, and in 
fact, will concentrate it through evaporation of the water.

The Alternative Water Program

    If you are expecting a baby, if you are a new resident, or 
expecting visitors from outside the area, please call [insert phone 
number of water system] to request delivery of alternative water to 
your home. We will provide you with sufficient water for the cooking 
and drinking needs for each sensitive person. We will provide you with 
two liters per day of bottled water for your infant for up to 20 weeks, 
during which time you should gradually add tap water to the bottled 
water. In this way, your baby will become gradually accustomed to the 
sulfate in the water. We will provide your out-of-town guests with two 
liters of bottled water per day for the period needed, up to a maximum 
of six weeks. We will provide new residents with two liters per person 
per day for up to six weeks. During that time, tap water should be 
gradually mixed with the bottled water. Restaurants and other 
establishments who are likely to serve at least some members of the 
target population on a continual basis may be provided individual 
treatment devices, depending on our evaluation of the size of the 
target population and other circumstances.
    (iii) New customers. The PWS shall provide notice of the following 
to new customers or billing units prior to or on the date service 
begins: Sulfate MCL exceedence in the water entering the distribution 
system, the health effect of sulfate for target populations, and the 
need to mix bottled water and tap water for gradual acclimation to 
sulfate.
    (iv) Pamphlets. PWSs shall deliver pamphlets to all physicians and 
all medical facilities within the PWS service area, including, but not 
limited to, city, county and State health departments, pharmacies, 
public and private hospitals and clinics, family planning clinics and 
local welfare agencies. The PWS shall request the operators of such 
facilities to make the pamphlets available, in particular, to pregnant 
women. The pamphlets shall contain the information in paragraph 
(r)(3)(ii) of this section. The pamphlet shall define the extent of the 
geographical service area in question.
    (v) Signs. A prominent, permanent sign in a durable material, such 
as plastic, shall be placed at each faucet, fountain or source of water 
which could be used for drinking water in places such as restaurants, 
hotels/motels, rest areas, campgrounds, gas stations and public areas 
where not all taps will have treated water. If such facilities are 
equipped with a POE device or with POU devices such that all taps 
deliver water in compliance with the sulfate MCL, sign posting is not 
required. The signs must state the location of the nearest source of 
water which complies with the sulfate MCL and why precautions should be 
taken by non-acclimated persons. The text of the sign, in multiple 
languages where appropriate, shall be as follows:

    This water contains high levels of sulfates. This mineral can 
cause diarrhea in persons not accustomed to drinking water with high 
sulfate content. Persistent diarrhea can cause dehydration. Special 
care should be taken for infants. Bottled water is available nearby 
at____________________.

    (vi) Notices to the media. PWSs shall submit copies of the notice 
described in paragraph (r)(3)(ii) of this section to radio and 
television stations that broadcast to the community served by the water 
system as soon as possible, but in no case later than 14 days after 
sulfate in excess of the MCL has been detected in the water, and once 
every six months while the water delivered into the distribution system 
exceeds the sulfate MCL. The geographical service area in question 
shall be indicated and clearly defined in the notice.
    13. Section 141.33 is amended by adding paragraph (e) to read as 
follows:


Sec. 141.33  Record maintenance.

* * * * *
    (e) Record maintenance requirements concerning a PWS's delivery of 
Alternative Water as a means of compliance with the MCL for sulfate are 
contained in Sec. 141.23(r)(2)(ii).


Sec. 141.51  Maximum contaminant level goals for inorganic 
contaminants. [Amended]

    14. The table in Sec. 141.51(b) is amended by adding ``Sulfate'' in 
alphabetical order under the column heading ``Contaminant'', and next 
to it, under the column heading ``MCL(mg/l)'' adding ``500''.


Sec. 141.62  Maximum contaminant levels for inorganic contaminants. 
[Amended]

    15. In the last sentence in paragraph Sec. 141.62(b), the word 
``and'' between ``(b)(8)'' and ``(b)(9)'' is removed, and ``and 
(b)(16)'' is added after ``(b)(9)''.


Sec. 141.62  [Amended]

    16. The table in Sec. 141.62(b) is amended by adding ``sulfate'' in 
alphabetical order under the column heading ``Contaminant'' and next to 
it, under the column heading ``MCL'' adding ``500''.


Sec. 141.62  [Amended]

    17. The table in Sec. 141.62(c) is amended by adding ``Sulfate'' in 
alphabetical order under the column heading ``Chemical Name'', and next 
to it, under the column heading ``BAT'' adding ``5, 7, 9''.
    18. Section 141.101 is amended by adding two sentences to the end 
to read as follows:


Sec. 141.101  Use of other non-centralized treatment devices.

    * * * The requirements of this section do not apply to the control 
of sulfate in drinking water by public water systems in States 
authorizing the Alternative Method of Compliance with the sulfate MCL. 
Instead, a public water system that chooses to use bottled water or 
point-of-use devices to achieve compliance with the MCL for sulfate 
must meet the requirements of Sec. 141.23(r).

PART 142--NATIONAL PRIMARY DRINKING WATER REGULATIONS--
IMPLEMENTATION

    19. The authority citation for part 142 continues to read as 
follows:

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

    20. Section 142.14 is amended by adding paragraph (d)(12) to read 
as follows:


Sec. 142.14  Records kept by States.

* * * * *
    (d) * * *
    (12) Records of notification received pursuant to 
Sec. 141.23(r)(1)(vi) of this chapter of the method of compliance 
chosen by PWSs which exceed the sulfate MCL.
* * * * *
    21. Section 142.15 is amended by adding paragraph (a)(4) to read as 
follows:


Sec. 142.15  Reports by States.

* * * * *
    (a) * * *
    (4) Notification of public water systems authorized to implement 
the Alternative Method of Compliance for sulfate.
* * * * *
    22. Section 142.16 is amended by adding paragraph (f) to read as 
follows:


Sec. 142.16  Special primacy requirements.

* * * * *
    (f) Sulfate requirements. The national primary drinking water 
regulation for sulfate in part 141 gives States the option to allow 
PWSs to use the Alternative Method of Compliance with the sulfate MCL 
contained in Secs. 141.23(r)(2) and (3) (see 141.23(r)(1)(ii)). If a 
State chooses to allow PWSs to use the Alternative Method of 
Compliance, its application for approval of a State program revision 
must include the text of State laws and regulations that are no less 
stringent than Secs. 141.23(r)(2) and (3) of this chapter. In addition, 
the State's application must include a description of the State's 
method for overseeing implementation by PWSs of the Alternative Method 
of Compliance. Such a description must include actions the State will 
take to assure compliance with bottled water requirements 
(Sec. 141.23(r)(2)(v) of this chapter), POU and POE device requirements 
(Sec. 141.23(r)(2)(vi) of this chapter), and public notification/
education program requirements (Sec. 141.23(r)(3) of this chapter).
    23. Section 142.62 is amended by adding one sentence to the end of 
paragraph (f) to read as follows:


Sec. 142.62  Variances and exemptions from the maximum contaminant 
levels for organic and inorganic chemicals.

* * * * *
    (f) * *  * The State may authorize a public water system to use 
bottled water, point-of-use or point-of entry devices to comply with 
the sulfate MCL, pursuant to Secs. 141.23(r)(1) through (3) of this 
chapter.
* * * * *
[FR Doc. 94-30953 Filed 12-19-94; 8:45 am]
BILLING CODE 6560-50-P