National Primary Drinking Water Regulations: Monitoring Requirements for Public Drinking Water Supplies: Cryptosporidium, Giardia, Viruses, Disinfection Byproducts, Water Treatment Plant Data and Other Information Requirements

Federal RegisterFeb 10, 1994

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SUMMARY: EPA is proposing to require public water systems which serve

10,000 people or greater to generate and provide the Agency with

specific monitoring data and other information characterizing their

water systems. Systems which use surface water, or ground water under

the influence of surface water, and serve between 10,000-100,000 people

would be required to (a) monitor their source water at the intake of

each plant for two disease-causing protozoa, Giardia and

Cryptosporidium; fecal coliforms or Escherichia coli; and total

coliforms; and (b) provide specific engineering data as it pertains to

removal of disease-causing microorganisms. Systems which use surface

water, or ground water under the influence of surface water, and serve

more than 100,000 people would be required to monitor their source

water at the intake of each plant for the microorganisms indicated

above, plus viruses, and, when pathogen levels exceed one pathogen/

liter in the source water, finished water for these microorganisms;

monitor for certain disinfection byproducts (DBPs) as well as other

water quality indicators; and provide specific engineering data as they

pertain to removal of disease causing organisms and control of DBPs.

All ground water systems that serve more than 100,000 people would be

required to monitor for certain DBP, other water quality indicators,

and to provide specific physical and engineering data. Systems which

use surface water and serve more than 100,000 people and systems which

use ground water and serve more than 50,000 people would be required to

conduct bench or pilot scale studies to evaluate treatment performance

for the removal of precursors to DBPs unless they have met certain

source water or treated water quality criteria. This information will

be used to consider possible changes to the current Surface Water

Treatment Rule (SWTR) and to develop drinking water regulations for

disinfectants and DBPs. If the SWTR is amended, information collected

under this monitoring rule would assist utilities in complying with

such amendments.

DATES: Comments should be postmarked or delivered by hand on or before

March 14, 1994. Comments received after this date may not be considered

because of time constraints.

ADDRESSES: Send written comments to ESWTR/DBPR Monitoring 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 and all comments

received are available for review at the Water Docket at the address

above. For access to Docket materials, call (202) 260-3027 between 9

a.m. and 3:30 p.m. for an appointment.

FOR FURTHER INFORMATION CONTACT: The Safe Drinking Water Hotline,

Telephone (800) 426-4791. The Safe Drinking Water Hotline is open

Monday through Friday, excluding Federal holidays, from 9 a.m. to 5:30

p.m. Eastern Time. For technical inquiries, contact Stig Regli or Paul

S. Berger, Ph.D., Office of Ground Water and Drinking Water (WH-550D),

U.S. Environmental Protection Agency, 401 M Street SW., Washington DC

20460, telephone (202) 260-7379 (Regli) or (202) 260-3039 (Berger).

SUPPLEMENTARY INFORMATION:

Table of Contents

I. Statutory Authority

II. Regulatory Background

III. Discussion of Proposed Rule

A. Enhanced Surface Water Treatment Requirements (ESWTR)

1. Need for Enhanced SWTR

2. Monitoring and reporting requirements and rationale

3. Reasons for monitoring listed pathogens and indicators

4. Rationale for frequency of microbial monitoring

5. Rationale for reporting physical data and engineering

information

6. Analytical methods

7. Laboratory approval

8. Quality assurance

B. Disinfection Byproducts Rule (Stage 2)

1. Need for additional data

2. Monitoring and reporting requirements and rationale

3. Treatment process information collection

4. Database development

5. Analytical methods

6. Quality assurance

7. Bench/pilot scale testing

C. Dates

D. Reporting Requirements

E. List of Systems Required to Submit Data

IV. State Implementation

V. Cost of Rule

VI. Other Statutory Requirements

A. Executive Order 12866

B. Regulatory Flexibility Act

C. Paperwork Reduction Act

D. Science Advisory Board, National Drinking Water Advisory

Council, and Secretary of Health and Human Services

VII. Request for Public Comments

VIII. References

I. Statutory Authority

The Safe Drinking Water Act (SDWA or the Act), as amended in 1986,

requires EPA to promulgate National Primary Drinking Water Regulations

(NPDWRs) which specify maximum contaminant levels (MCLs) or treatment

techniques for drinking water contaminants (42 U.S.C. 300g-1). NPDWRs

apply to public water systems (42 U.S.C. 300f(1)(A). Section 1412(b)(3)

of the Act requires EPA to publish regulations for at least 25

contaminants at three year intervals. Section 1412(b)(9) of the Act

requires EPA to review existing national primary drinking water

regulations at least once every 3 years.

According to section 1445(a)(1) of the Act, every public water

system ``shall establish and maintain such records, make such reports,

conduct such monitoring, and provide such information as the

Administrator may reasonably require by regulation to assist him in

establishing regulations, [or] * * * in evaluating the health risks of

unregulated contaminants''. This section authorizes EPA to require

systems to monitor and provide the Agency with these data as well as

other data characterizing the system, including source and treated

water quality.

In addition, section 1401(1)(d) of the Act defines NPDWRs to

include ``criteria and procedures to assure a supply of drinking water

which dependably complies with such maximum contaminant levels;

including quality control and testing procedures * * * ''. This section

authorizes EPA to require systems and laboratories to use Agency-

approved methods and quality assurance criteria for collecting and

analyzing water samples.

II. Regulatory Background

Two regulations attempt to control disease-causing microorganisms

(pathogens) in public water supplies--the Total Coliform Rule (54 FR

27544; June 29, 1989) and the Surface Water Treatment Requirements

(SWTR) (54 FR 27486; June 29, 1989). A third regulation, the

Groundwater Disinfection Rule, which is currently under development,

will add further protection for systems using ground water. The Agency

is considering revising the SWTR in conjunction with the development of

other new regulations.

Another rule EPA is currently developing will address chemical

byproducts that form when disinfectants used for microbial control in

drinking water react with various organic chemicals in the source

water. Some of these disinfection byproducts are toxic or are probable

human carcinogens. As such, they were included on the 1991 Drinking

Water Priority List (56 FR 1470; January 14, 1991) as candidates for

future regulations. They are among the candidate contaminants for which

EPA must meet a Court-ordered deadline that is currently being

negotiated.

To develop the Disinfectant/Disinfection Byproducts (D/DBP) Rule,

EPA instituted a formal regulation negotiation process in 1992 (57 FR

53866; Nov 13, 1992) including representatives from water utilities,

State and local agencies, environmental groups, consumer groups, and

EPA. The Negotiating Committee agreed to propose three rules: a) an

information collection rule (ICR), which is proposed herein, b) an

``interim'' enhanced surface water treatment rule (ESWTR), to be

proposed within the next few months, and c) D/DBP regulations, to be

proposed concurrently with the interim ESWTR.

During the development of the D/DBP Rule, a number of members of

the Negotiating Committee did not believe that there were adequate data

available to address some of the DBPs on EPA's priority list (56 FR

1473; January 14, 1991). They believed that insufficient data were

available on many aspects of DBPs necessary to make appropriate

regulatory decisions including health effects and health effect related

issues, occurrence of and exposure to contaminants, and the

capabilities of treatment technologies. Also of concern were the

limited data on microbial contaminants for making regulatory decisions.

The Negotiating Committee's development of the three proposed rules

mentioned above was based on the premise of (1) taking prudent

immediate steps by proposing a two staged D/DBP rule and an interim

ESWTR, and (2) developing additional data through monitoring and

research for future regulatory decisions that would support refinements

to the proposed interim ESWTR and the Stage 2 D/DBP rule. For example,

decisions on the direction of an ESWTR will be limited without more

data on the occurrence of microorganisms, the effectiveness of current

and advanced treatment schemes, potential consumer exposure, dose

response relationships for certain pathogens, pathogen strain

differences, and cyst/oocyst viability measures. Likewise, important

decisions on the Stage 2 D/DBP rule would benefit from additional data

on occurrence of DBPs, effects of current and advanced treatment

approaches on DBP formation, potential consumer exposures, acute short-

term health effects, chronic health effects, and the use of surrogates

as tools for defining adequacy of treatment for specific contaminants

and reduced monitoring.

The ICR was developed to obtain both microbial and DBP occurrence,

exposure, and treatment data for input to the ESWTR and Stage 2, as

outlined below, and would require the expenditure of an estimated $130

million over three and a half years by a segment of public water

suppliers. The commitment by the public water supply community to

support the collection of additional data was linked to EPA's

commitment to provide (1) adequate quality control procedures for

collecting and managing the information obtained under the ICR and (2)

additional funding, especially on health effects, for properly

interpreting the data collected under the ICR. As evidence of this

linkage, non-EPA members of the Negotiating Committee sought to assist

the Agency in obtaining funding for the health effects and other

research equally critical to the future decisions. On May 20, 1993,

these committee members sent letters to the Administration and members

of Congress requesting support for a federal commitment of $4 million

per year for five years to support the needed research. The letters

noted that the American Water Works Association Research Foundation

had, independent of the negotiations, presented a public-private

partnership research plan under which they committed to provide up to

$2 million per year for the research under a one for two match.

On a related effort, non-EPA Negotiating Committee members

requested on July 14, 1993, in a letter to EPA's Administrator,

consideration of reallocation of Agency research funds to support the

research needs described above. The July 14, 1993 letter also spoke of

the need for the Agency to commit funds necessary to adequately

collect, manage, and analyze data collected under the ICR. A number of

Negotiating Committee members believed that, without additional federal

research and data management funding, the ICR data generated by systems

would not be particularly useful in developing the ESWTR or Stage 2 D/

DBP Rule.

The Negotiating Committee agreed that more data, especially

monitoring data, should be collected under the ICR to assess possible

shortcomings of the SWTR and develop appropriate remedies, if needed,

to prevent increased risk from microbial disease when systems began

complying with the new D/DBP Rule. It was also agreed that EPA would

propose an interim ESWTR for systems serving greater than 10,000 people

that included a wide range of regulatory alternatives. Data gathered

under the ICR would form the basis for developing the most appropriate

criteria among the options presented in the proposed interim ESWTR, and

eventually for a long-term ESWTR that would include possible

refinements to the interim ESWTR and be applicable to all system sizes.

Both of these ESWTR rules would become effective concurrently with the

requirements of the Stage 1 D/DBP rule for the respective different

system sizes.

The Negotiating Committee also agreed that additional data on the

occurrence of disinfectants, DBPs, potential surrogates for DBPs,

source water and within-treatment conditions affecting the formation of

DBPs, and bench-pilot scale information on the treatability for removal

of DBP precursors would be useful for developing Stage 2 D/DBP

regulatory criteria beyond those currently being considered for

proposal in Stage 1. To this end, today's proposed ICR rule, which

would require this additional information, was accepted as necessary

and reasonable by the Negotiating Committee.

III. Discussion of Proposed Rule

A. Enhanced Surface Water Treatment Requirements

1. Need for Enhanced SWTR

The SWTR, which became effective on December 31, 1990, requires all

systems using surface water, or ground water under the direct influence

of surface water, to disinfect. It also requires all such systems to

filter their water unless they can demonstrate that they have an

effective watershed protection program and can meet other EPA-specified

requirements. The SWTR also specifies that systems using surface water

must treat water to remove/inactivate at least 99.9% (3 logs10) of

the Giardia lamblia cysts (a protozoan) and at least 99.99% (4

logs10) of the viruses. The SWTR does not require a system to

monitor its source water or drinking water for these pathogens.

During the development of the SWTR, the United States experienced

its first large recognized waterborne disease outbreak of

cryptosporidiosis, caused by the protozoan, Cryptosporidium (Hayes et

al., 1989). Other outbreaks caused by this pathogen have since been

reported both in the United States and other countries. Because of the

lack of data before 1989 on Cryptosporidium oocyst occurrence and

susceptibility to treatment, EPA decided to regulate this pathogen in a

future rulemaking, rather than to delay publication of the SWTR until

these data were available. EPA and others are now performing research

to understand the health risks posed by Cryptosporidium. Although some

occurrence and treatment data are now available, EPA believes that much

more is needed before EPA can promulgate a suitable regulation for

Cryptosporidium. EPA is planning to propose an MCLG and treatment

technique requirement for Cryptosporidium in the ESWTR, and use the

data from this rule to determine the need for, and specifics of, that

regulation.

Another shortcoming of the SWTR is that a 3-log removal/

inactivation of Giardia and a 4-log removal/inactivation of enteric

viruses may be inadequate when a system is supplied by a poor quality

source water. In developing the SWTR, EPA assumed on the basis of data

available at that time, that this level of treatment was adequate for

most systems. The Agency published associated guidance recommending

greater treatment for systems supplied by poor quality source waters

(EPA, 1991).

Subsequent data on Giardia densities in source water and drinking

water (LeChevallier et al., 1991a,b), however, bring into question the

assumption that the treatment specified in the SWTR was adequate for

most systems. These new data suggest that Giardia cyst concentrations

in the source waters of many systems may be too great for the specified

minimum level of treatment to adequately control waterborne giardiasis

(to be discussed in the preamble of the forthcoming proposed interim

ESWTR).

As a result of this uncertainty, EPA needs much more data on the

concentration of Giardia cysts and viruses for various qualities of

source waters, with variation over time and seasonal influences, to

determine the need for additional treatment to provide adequate Giardia

and virus control. In addition, EPA needs more field data on the

effectiveness of different types of water treatment for controlling

these pathogens.

If these new data indicate that EPA's original assumption was

correct, i.e., that only a small percentage of systems have source

water Giardia and virus concentrations that are too great for adequate

control under the SWTR, then guidance (EPA, 1991) may suffice and no

revision of the SWTR would be needed. In contrast, if a high percentage

of systems have elevated concentrations of Giardia, then EPA believes

that the SWTR may need to be revised to require additional treatment

for such systems.

If the data indicate that a revision of the SWTR is needed, then

one regulatory option would be to tailor required treatment levels to

Giardia concentrations in the source water. For example, the Agency

might require a system to achieve at least a 99.9 percent (3-log)

reduction if the source water(s) contained less than 1 cyst/100 liters,

a 99.99 percent (4-log) reduction if the source water(s) contained 1 to

9 cysts/100 liters, a 99.999 percent (5-log) reduction if the source

water(s) contained 10 to 99 cysts/100 liters, and a 99.9999 percent (6-

log) reduction if the source water(s) contained more than 99 cysts/100

liters. These suggested level of treatment requirements are consistent

with existing EPA Guidance (USEPA 1991). Based on the dose response

curve developed by Rose et al (1991) these levels of treatment have

been predicted to ensure a risk of less than 1 infection per 10,000

people per year. The concept of utilities providing higher levels of

treatment to meet a desired acceptable risk level will be one of the

options discussed in the preamble of the forthcoming proposed ESWTR.

The data collected under today's monitoring rule, if promulgated, could

be used as the basis for the treatment level prescribed.

If EPA decides to revise the SWTR according to the above or similar

approach, then the monitoring data would assist the Agency in

determining the most appropriate manner for calculating source water

pathogen densities. For example, options include the arithmetic means,

geometric means, highest value, or a 90th percentile value (e.g., for

ten data points, the system would select the second highest, or for 18

data points, the system would select the third highest). These options

will be discussed in greater detail in the forthcoming proposed interim

ESWTR. These proposed revisions would be modified or withdrawn based on

monitoring data collected under the present rule.

In summary, today's proposed rule, if promulgated, would provide

the Agency with much needed field data to determine the need for

amending the SWTR to control microorganisms in an appropriate manner.

Data collected under this proposed rule could also form the basis by

which systems could establish levels of treatment, perhaps beyond those

minimally required under the SWTR, that are appropriate for controlling

microbial risk while complying with new D/DBP regulations. EPA

understands that the water industry may voluntarily provide additional

useful data for these purposes. The data collected under today's

proposed rule, if promulgated, would also support the long-term ESWTR

rule.

2. Monitoring and Reporting Requirements and Rationale

The rule would require systems using surface water that serve a

population greater than 100,000 (about 233 systems nationally) to

monitor their influent to each plant for Giardia cysts, Cryptosporidium

oocysts, ``total culturable viruses'' (hereafter referred to as

``viruses'', unless otherwise indicated), fecal coliforms or

Escherichia coli, and total coliforms. Monitoring would be monthly for

18 months. If a plant has several sources of water, the system must

sample the blended water from all sources or, if this is not possible,

sample the source with the expected highest pathogen concentration. If,

during the first twelve months of monitoring, any pathogen were to

exceed a density of one/liter, or if the detection limit for any

pathogen exceeds one/liter, the system would be required to monitor

their finished water for the entire set of pathogens and indicators at

the same frequency as source water sampling for the remaining months.

Under this rule, systems would not be required to continue

monitoring for viruses if: (1) viruses are not detected in the source

water at the intake (for each plant) during the first twelve months of

monitoring, or (2) the system has tested the source water at the intake

(for each plant) for either total coliforms or fecal coliforms at least

five times per week between [insert first day of month, 4 months prior

to the promulgation date of this rule] and [insert first day of month,

2 months after the promulgation date of this rule], and the density of

total coliforms or fecal coliforms is less than 100 colonies/100 ml or

20 colonies/100 ml, respectively, for at least 90% of the samples.

For surface water systems that serve between 10,000 and 100,000

people, the rule would require source water monitoring at the intake of

each plant for the organisms listed above, except that they would not

have to monitor for viruses. Monitoring for this category of systems

would be every two months for 12 months. The rule would require all

systems serving more than 10,000 people to provide the above monitoring

data and other, system-specific information to EPA. The rule would not

apply to systems that purchase all of their water from other systems.

The rationale for requiring this information is to provide EPA with

much needed data on the concentrations and variations with time of

viral and protozoan pathogens in various types of source waters. It

would also help EPA evaluate whether current assumptions on water

treatment removal efficiencies for pathogenic protozoa and viruses are

appropriate. Together, these data and the data on source water

concentrations would provide EPA and the system a better understanding

of pathogen concentrations following treatment, which would allow for a

more accurate assessment of the pathogen levels and the associated

health risk to which the public may be exposed. These data, along with

possible additional data on dose-response patterns, pathogen strain

differences, and cyst/oocyst viability measures, would allow EPA to

determine the circumstances under which the SWTR is not adequate and to

revise this rule accordingly to overcome any shortcomings.

The data would also help EPA characterize occurrence relationships

among Giardia cysts, Cryptosporidium oocysts, and viruses. For example,

these data would help the Agency evaluate the merits of using Giardia

as the primary target to define treatment requirements, as it did in

the SWTR. In addition, the data may help EPA identify and prevent

treatment changes that systems might inappropriately consider to meet

the forthcoming D/DBP rule.

The source water data collected under this rule might also be used

for determining appropriate levels of treatment for particular systems

serving more than 10,000 people, if minimum treatment requirements were

specified as a function of source water quality conditions under the

interim ESWTR.

EPA would not require systems serving between 10,000 and 100,000

people to monitor treated water because the Agency believes that

sufficient data for microorganisms would be provided by the larger

systems, which are generally better able to fund the collection of the

needed data. EPA would also not require these sized systems to monitor

viruses in source waters because the Agency believes that the larger

systems would provide sufficient data to establish any relationship

between the viruses and the two protozoan pathogens being monitored,

regarding source water densities and treatment effectiveness. The

Agency, in the absence of data suggesting otherwise, would continue to

use Giardia, possibly including Cryptosporidium, as the primary target

organism(s) for regulation, given their greater disinfection resistance

compared to most other organisms, and consequently less data would be

needed for the viruses.

The data from these larger systems would also be useful for

estimating pathogen concentrations in many source waters serving

systems with fewer than 10,000 people, which EPA believes typically do

not have the financial resources or technical expertise to collect and

process the samples as part of the above monitoring requirements. The

Agency would use the large system data to define the relationship

between the pathogen concentrations in the source water and the

concentrations of potential/existing microbial indicators of water

quality. If such a relationship were found, then small systems could

use one or more of these easily-measured indicators to estimate

pathogen concentrations in their source waters.

In addition, small systems that use the same source water and are

in the same vicinity as a large system may be able to use the same

pathogen concentrations measured by the large system as a basis for

determining the minimum level of treatment required. Finally, EPA may

be able to use these data to develop national occurrence patterns that

would allow the Agency to establish more appropriate treatment criteria

for small systems. By characterizing source water quality using any one

or a combination of these three approaches, a small system could

evaluate the effectiveness of treatment in place for pathogen control

and determine the need for additional treatment steps.

The Agency requests suggestions for assessing pathogen exposure in

small systems in addition to the three approaches provided above.

Following the full compilation of data under the ICR and other research

developments, EPA is considering proposing a long-term ESWTR that would

include criteria by which systems serving less than 10,000 people could

determine appropriate levels of treatment for different source water

qualities.

As stated above, under this proposed ICR, systems using surface

water and serving more than 100,000 people would be required to monitor

their finished water for the entire set of pathogens and indicators if

any pathogen density in the source water were to exceed one/liter.

Since pathogen occurrence in a particular source water can vary by

several orders of magnitude, a pathogen density of slightly greater

than one/liter during one month might be followed by considerably

greater densities in subsequent months. Requiring a system to monitor

its raw and filtered water concurrently in the months following a

source water pathogen concentration of greater than one/liter would be

more likely to result in pathogen detection in the filtered water

compared to a situation where source water pathogen densities are less

than one/liter. EPA believes that, at Giardia occurrence levels above

one/liter or virus occurrence levels above 10/liter, a 3-log Giardia

reduction or 4-log virus reduction, depending upon the efficacy of

treatment, should still be countable in the treated water. At a density

less than one/liter in source water, the sample volume needed to detect

pathogens in treated waters would be unreasonably high and technically

difficult to achieve.

To avoid virus monitoring that is likely to be uninformative

because of exceptionally good source water quality, EPA would allow two

circumstances under which a system that serves more than 100,000 people

could forgo all or part of the virus monitoring requirement. In one

case, a system that does not detect any viruses during the first twelve

months of monitoring would not be required to monitor viruses during

the last six months of monitoring. In the other case, if a system has

monitored for total coliforms or fecal coliforms in the source water

for at least five days/week every week for six months before the

effective date of this rule, and 90 percent of all samples are no

greater than 100 total coliform/100 ml or 20 fecal coliforms/100 ml,

the system may forgo the virus monitoring requirement, per approval by

EPA upon submission of this data. EPA believes that systems that do not

detect viruses during a full year of monitoring, or where the densities

of total coliforms or fecal coliforms do not exceed the values

specified in the SWTR above which a system is required to filter, could

assume that treatment that removes/inactivates Giardia satisfactorily

would also reduce viruses to a safe level.

One issue raised during rule development is whether a system could

submit previously collected monitoring data in lieu of part or all of

the data required by this rulemaking. EPA believes such data would be

useful only if (1) the laboratory used the same analytical methods

approved under this rulemaking, (2) the Agency has some assurance that

the laboratory used adequate quality assurance procedures in analyzing

the samples, (3) the system provides all data, rather than selected

data, and that these data include seasonal information, and (4) the

laboratory analyzed the full set of pathogens and bacterial indicators

required by this rule so that microbial interrelationships can be

evaluated. The Agency solicits comment on whether to allow systems to

submit previously collected data in lieu of the requirements of this

rulemaking and, if so, the appropriateness of the criteria outlined

above regarding the admissibility of such data.

Another issue is whether EPA should require systems to submit some

percentage of their processed microbiological samples to the Agency or

some other repository for archiving. Such a repository would allow EPA,

States, systems, and research centers to study the samples in the

future for any newly identified pathogens or any additional

relationships. Also, a repository could allow for very efficient

research since particular samples of interest could be selected from

the same sites based on previous ICR monitoring results. The previous

data could, in part, be validated using new analytical methods that

become available in the future. An examination of archived data may

allow EPA to require monitoring of an easily measured indicator rather

than pathogens in any future rulemaking.

If the Agency determines that archiving is appropriate, based on

public comments received, EPA would facilitate its implementation by

making any requirement as simple as possible for systems and

laboratories. For this purpose, EPA intends to serve as the repository

for all archived samples under this rule. For Giardia/Cryptosporidium

samples, systems/laboratories would collect a total volume of at least

140L and 1400L for raw and treated waters, respectively, and send

approximately one-fourth of the sample concentrate (\1/4\ of the

pellet), i.e., about 5 ml of sediment in 5 ml of formalin, to EPA for

archiving under refrigeration. For viruses, systems/laboratories would

collect a total volume of at least 200L and 1400L for raw and treated

waters, respectively, and ship a 100-ml filter eluant (pH neutralized)

on dry ice to EPA for each sample.

EPA solicits comment on the feasibility and utility of archiving

samples.

EPA also requests comment on the option for requiring systems to

collect particle size count data within the treatment plant in lieu of,

or in addition to, finished water monitoring for Giardia and

Cryptosporidium. The intent of the finished water monitoring is to

provide data on removal efficiencies throughout the treatment process,

and applicability of pathogen removal credits for various treatment

processes. However, because suspended solids in some source waters may

clog the filters and thus limit the sample volume collected, systems

may only be able to determine an upper limit for pathogen

concentration, i.e., less than the detection limit, rather than an

actual concentration. This problem would preclude a system from

calculating pathogen reduction efficiencies by treatment. Additionally,

the analytical method currently specified does not clearly

differentiate between live or dead cysts/oocysts of Giardia and

Cryptosporidium. Potential public misunderstandings of cysts/oocysts

detected in plant effluent is another reason to allow particle count

data.

Removal efficiencies indicated by particle count data may

approximate removal efficiencies of Giardia cysts and Cryptosporidium

oocysts. Particle size counting may be used as a tool for evaluating

removal efficiencies of physical removal processes. Ongoing research

may provide enough information to establish a quantitative relationship

between reductions by treatment of particle counts of specific size and

reductions of Giardia cysts and Cryptosporidium oocysts. Due to

recovery problems of Giardia and Cryptosporidium by the methodology and

the inability to quantitate removal efficiencies in many waters, the

use of particle counts in the same or smaller size range as Giardia and

Cryptosporidium may be a better method for the evaluation of removal

efficiencies by treatment.

The intent of the option for allowing particle size measurements in

lieu of finished water monitoring for Giardia and Cryptosporidium is to

obtain data on the use of particle count data as a surrogate for

Giardia and Cryptosporidium removal. Under this option particle counts

would be taken on the plant influent, settled water, filter effluent,

and plant effluent. The particle count data would be taken on the same

day as the plant influent data for Giardia and Cryptosporidium.

The particle count data would be recorded on a form similar to that

shown in Appendix A of this preamble. The data would be recorded as

particle size counts for each treatment step between the plant influent

and effluent. By requiring particle size counts in increments of

``greater than'' values for some specified volume of flow, removal

efficiency for a specified particle size range (e.g., 5-10 m),

could be calculated for a particular treatment process. This would be

done by subtracting the count in the higher size range (e.g., >10

m) from the count in the lower size range (e.g., >5

m) for the effluent of one treatment process (or the raw

water) and comparing this value, ``a'', to a similarly calculated

value, ``b'', for a subsequent treatment process (i.e., [``a'' -

``b'']/``a'' x 100). Removal efficiencies calculated based upon

particle size counts in the ranges of 2-5 m and 5-10

m, as indicated in Appendix A of this preamble, may be

conservative indicators for estimating the removal efficiency of

Giardia or Cryptosporidium which are generally in the respective size

ranges of 3-7 microns and 8-12 microns, respectively.

EPA solicits comment on the following issues pertaining to

monitoring of particle size counts: Under what circumstances, if any,

should monitoring of particle size counts be allowed in lieu of

monitoring finished water for Giardia and Cryptosporidium? What

particle size ranges and sample volumes should be monitored? What

analytical method(s), including instrumentation, should be used for

such monitoring? What criteria should be specified to ensure that

particle size data collected from different systems could be

appropriately compared? What criteria should be specified to ensure

that the particle size measurements would be most representative of

removal of Giardia and Cryptosporidium? Should methods in addition to,

or in lieu of, particle size counting, such as Microscopic Particulate

Analysis (MPA), be included as a condition for avoiding finished water

monitoring of Giardia and Cryptosporidium?

3. Reasons for Monitoring Listed Pathogens and Indicators

EPA would require monitoring of Giardia concentrations because this

pathogen causes more reported waterborne disease outbreaks than any

other single known pathogen and is more resistant to environmental

stresses and disinfection than almost all other known waterborne

pathogens. The Agency would require monitoring of Cryptosporidium

because this pathogen has caused major waterborne disease outbreaks in

the United States, England, and elsewhere, and is even more resistant

to disinfection than is Giardia. Cryptosporidium may also not be as

readily removed by filtration as Giardia, given its smaller size.

A number of enteric viruses have caused waterborne disease and they

may be responsible for many, if not most, of the outbreaks where a

causative agent was not specifically identified (about half of all

reported outbreaks). EPA believes, however, that it would be

prohibitively expensive to monitor for all of them, using current

technology. Moreover, adequate analytical methodology is not yet

available for routine analysis for many of them. For this reason, the

Agency would require systems to monitor total culturable viruses (as

determined by BGM (Buffalo Green Monkey) tissue cultures), a group of

enteric viruses that are commonly found in fecally polluted waters and

which EPA believes are at least somewhat representative of other

pathogenic enteric viruses. Total culturable viruses contain some

strains that are capable of causing waterborne disease, have been

widely studied for many years, and analytical methods are far better

defined for them than is the case for many specific enteric viruses.

EPA believes that monitoring for total culturable viruses is useful

both because this group of viruses contains pathogens and is a

potential indicator for other viral pathogens.

Some individuals believe that systems which satisfactorily control

for Giardia cysts will adequately control for pathogenic viruses, since

viruses generally are much less resistant to disinfection than are

Giardia cysts, and thus virus monitoring is not warranted under this

rulemaking. They point out that, based on the Guidance Manual to the

Surface Water Treatment Requirements (EPA, 1991), the disinfection CT

values (disinfection concentration in mg/l x disinfection contact time

in minutes) for achieving the SWTR compliance level inactivation of

viruses, which is based on hepatitis A inactivation data, is about one

to two orders of magnitude below that for achieving the SWTR compliance

level of inactivation of Giardia.

EPA, however, does not believe that sufficient data are yet

available to conclude that the Giardia density in source waters is an

adequate gauge to define the necessary treatment for viruses in all

types of source waters. The Agency is not aware of data on relative

densities between Giardia and viruses in source water. If the virus

concentration in some source waters greatly exceeds that of Giardia,

and some pathogenic viruses are significantly more resistant to

disinfection than is hepatitis A, an adequate treatment for Giardia may

not result in adequate control of viruses. Moreover, the Agency notes

that viruses have often been detected in fully treated waters (i.e.,

coagulation, sedimentation, filtration, and disinfection) (Gerba and

Rose, 1990; Payment et al., 1985; Hurst, 1991), and it is not aware of

any data demonstrating that viruses in raw water or treated water are

usually or always accompanied by Giardia cysts. The Agency also notes

that the CT values for viruses in the Guidance Manual to the SWTR (EPA,

1991) were based upon laboratory studies on free (i.e., non-aggregated)

viruses; in environmental waters, viruses are usually aggregated or

associated with cell debris, some of which may not be removed entirely

by filtration processes. Such cell-associated aggregates are

considerably more resistant to disinfection than free viruses

(Williams, 1985; Sobsey et al., 1991). Moreover, some pathogenic

enteric viruses may be substantially more resistant to disinfection

than others (Keswick et al., 1985).

Because of these uncertainties, it may not be appropriate to assume

that by controlling Giardia densities, systems will adequately control

viral pathogens. EPA needs monitoring data from many systems nationwide

to determine the level of treatment needed to control viruses.

Specifically, the Agency needs to determine the extent to which Giardia

are present in source waters when viruses are present. The Agency also

needs to determine what minimum level of disinfection inactivation is

necessary for surface water supplies to ensure adequate virus control,

regardless of Giardia densities. These data will allow the Agency to

determine whether a system that consistently provides an overall

Giardia reduction of 3-logs (of which at least 0.5-log is due to

disinfection alone) or any greater reduction level for Giardia, will

also consistently provide an adequate control for viruses, especially

in cases where virus densities in source waters are much higher than

those for Giardia. Information collected under this rule would provide

part of these data. The Agency believes that these data, along with a

more intensive voluntary monitoring effort among a small number of

systems, should clarify this situation sufficiently to allow it to

develop suitable revisions to the SWTR.

With regard to bacterial pathogens, EPA believes that pathogenic

protozoa and many waterborne viruses are more resistant to

environmental stress and disinfection than most enteric bacteria that

cause waterborne disease. Thus a system that protects the public from

pathogenic protozoa and viruses will concurrently protect them from

most pathogenic bacteria (except possibly for those bacteria that can

proliferate within the distribution system or which have special

protective factors). For this reason, EPA would not require these

systems to monitor pathogenic bacteria in the source water or in

treated water.

While EPA would not require systems to monitor pathogenic bacteria,

the Agency would require them to monitor potential bacterial indicators

for waterborne pathogens in source water and treated water. Under this

rule, EPA is proposing to require systems to monitor for total

coliforms and either fecal coliforms or E. coli. Total coliforms and

fecal coliforms have been used widely for decades to assess source

water quality, testing for these two groups of bacteria is very simple

and inexpensive, and systems are familiar with these tests. Total

coliforms are usually much more numerous in water than fecal coliforms,

and therefore enumeration in source waters and treated water is more

sensitive than with fecal coliforms. However, fecal coliforms are a

better indicator of fresh fecal contamination than are total coliforms.

Because the bacterium E. coli is more closely related to fresh fecal

pollution and to gastrointestinal illness among bathers than are fecal

coliforms, EPA would allow a system to analyze for E. coli in lieu of

fecal coliforms.

EPA solicits comment on the requirement to monitor the specific

pathogens and bacterial indicators mentioned above. The Agency

specifically seeks comment on whether to require systems to monitor

both fecal coliforms and E. coli, rather than one or the other. In

addition, the Agency may include a requirement to monitor for two other

potential indicators--Clostridium perfringens (C. perfringens) and

coliphage which are discussed below.

Clostridium perfringens. C. perfringens is a bacterium that is

common in the intestinal tract of warm-blooded animals. This organism

forms an endospore in the environment that is extremely resistant to

environmental stresses and disinfection. Of the more than 60 species of

Clostridium, C. perfringens is the one most consistently associated

with human fecal wastes (Cabelli, 1977). It is consistently present in

human feces at a relatively high density (Bisson and Cabelli, 1980) and

appears to be excreted in greater numbers than are fecal pathogens

(NATO, 1984). There is controversy over whether other important animal

hosts exist, since C. perfringens spores are widely found in

terrestrial and aquatic environments (Cabelli, 1977). The survivability

of C. perfringens spores in water and their resistance to treatment

compared to the pathogens is much greater than other indicators (Bonde,

1977), except possibly for Giardia and Cryptosporidium. Analysis is

relatively easy and inexpensive. The European Community has a

supplementary standard for the endospores of sulfite-reducing

Clostridium for drinking waters.

Recently, Payment and Franco (1993) published a paper that showed

that C. perfringens may be a suitable indicator for viral and protozoan

pathogens in both raw water and filtered water. In this study, the

investigators collected large-volume samples from three water treatment

plants and analyzed them for Giardia cysts, Cryptosporidium oocysts,

cultivable human enteric viruses, Clostridium, and somatic and male-

specific coliphage. They found that Clostridium densities were

significantly correlated with the densities of viruses, cysts, and

oocysts in river water and with viruses and oocysts (but not Giardia

cysts) in filtered water.

For the above reasons, EPA is considering a requirement that

systems monitor their source and filtered water for C. perfringens at

the same frequency as is being proposed for the other organisms. C.

perfringens may be appropriate as a low cost monitoring indicator for

estimating pathogen densities in the source water and/or for defining

treatment effectiveness. If feasible, such an indicator could greatly

reduce monitoring costs for determining appropriate levels of treatment

to address microbial concerns. This would be of special benefit for

smaller systems under the long-term ESWTR. EPA solicits comment on this

issue.

Coliphage. The Agency also seeks comment on the utility of

coliphage as an indicator of pathogen presence. Coliphages, which are

viruses that infect the bacterium E. coli, are far simpler to analyze

than other viruses and are, like E. coli, generally associated with

fecal contamination. They have often been discussed as a possible

indicator of treatment effectiveness for enteric viruses. Coliphages

are commonly categorized into two groups: the somatic phage and the

male-specific (or F-specific) phage. The somatic phage gain entry into

E. coli cells via the cell wall, while the male-specific phage gain

entry only through the sex-pili of those E. coli cells that have them

(referred to as male cells).

Because coliphages are so much simpler to analyze than human

viruses, EPA wants to determine whether systems can use coliphages to

indicate the presence of the human viruses in source waters and

filtered water. Data on relative densities in natural waters are

sparse. Somatic phages are common in the feces of humans and other

animals but, unlike human viruses, some of them apparently can multiply

in natural water, probably in species other than E. coli. Male-specific

phages are not common in humans and other animals, but are common in

sewage, suggesting they can multiply in the sewerage system (IAWPRC,

1991). Data on the relative resistance and removal of coliphages and

human viruses during the water treatment process is also scarce, and

the data which exist are inconsistent, especially for the somatic

phages (IAWPRC, 1991). Some of the male-specific phages (e.g., MS2),

however, appear to be more resistant to chemical disinfection than most

waterborne pathogens (Sobsey, 1989).

One recent study suggests that coliphages are suitable as an

indicator for viruses, at least in filtered water. In the Payment and

Franco (1993) study indicated above, the densities of somatic

coliphages (E. coli CN13 host) were statistically correlated with human

enteric viruses and Cryptosporidium oocysts (but not Giardia cysts) in

filtered water, and not in river water. Male-specific coliphages

(Salmonella typhimurium WG49 host) were correlated with human enteric

viruses in filtered water, but not in river water. The male-specific

coliphages were also correlated with Giardia cysts, but not

Cryptosporidium oocysts, in river water.

In another study, Havelaar et al. (1993) compared the

concentrations of culturable viruses (BGM cell line) with those of

thermotolerant coliforms, fecal streptococci, and male-specific RNA

phages (Salmonella typhimurium WG49 host) for a variety of water types.

The investigators found that the male- specific phages were

significantly correlated (significant at P g/ml of 4-

methylumbelliferyl-beta-D-glucuronide (MUG), as specified in

Sec. 141.21(f)(6)(i). In this method, each total coliform-positive

broth culture from the Multiple Tube Fermentation (MTF) Technique

(Sec. 141.74(a)(2)) or each total coliform-positive colony from the

Membrane Filter Technique (Sec. 141.74(a)(2)) is transferred to 10 ml

of EC + MUG. After incubation, the inoculated medium is examined with

an ultraviolet light. If fluorescence is observed, the medium contains

E. coli.

(2) Nutrient agar supplemented with 100 g/ml of MUG, as

specified in Sec. 141.21(f)(6)(ii), with the additional requirement

that E. coli colonies be counted.

(3) Minimal Medium ONPG-MUG Test, often referred to as the Colilert

Test, as specified in Sec. 141.74(a)(2), with the additional

requirement that total coliform-positive tubes be examined with an

ultraviolet light. If fluorescence is observed, the medium contains E.

coli.

Giardia, cryptosporidium, and total culturable viruses. In August

1993, EPA sponsored a workshop of invited experts in Giardia,

Cryptosporidium, and virus analysis and quality assurance procedures to

help the Agency develop standardized methods for these organisms for

use with the ICR. Workshop participants included representatives from

academia; water industry; commercial laboratories; and federal, State

and local governments. As the basis for the discussion, the workshop

used the Giardia/Cryptosporidium method published by ASTM (1992) and

the method to be published shortly in the 18th edition Supplement to

Standard Methods for the Examination of Water and Wastewater. Two virus

methods in the 18th edition of Standard Methods (Method 9510C for virus

collection and elution; Method 9510G for virus assay) (APHA, 1992) were

used. The methods in ASTM (1992) and Standard Methods were used as the

basis for this discussion because these texts are highly respected and

widely used references that have been peer-reviewed throughout the

scientific community. The workshop generally recommended use of the

methods above, but, because these methods allow many sub-options,

decided to refine and standardize them to achieve more precise

comparisons among systems under the ICR (USEPA, 1993a).

The method for Giardia/Cryptosporidium, as revised, is in Appendix

C of the proposed rule. This method includes sample collection,

purification, and microscopic assay, and allows the density of Giardia

and Cryptosporidium to be determined simultaneously on the same sample.

The microscopic assay includes the use of epifluorescence along with

differential-interference- (or Hoffman Modulation) contrast optics to

identify morphological characteristics.

One issue with regard to the Giardia/Cryptosporidium method

concerns how to express the results. The total number of cysts and

oocysts are counted, based on immunofluorescence, size, shape, and

presence of internal structures. Then the total number of cysts with

internal structures is tallied. The issue is what terminology to use

for these two steps. One procedure is to categorize the first step as a

``presumptive'' test and the second step as the ``confirmed'' test. The

terminology ``confirmed'' could be used if at least two internal

structures are identified as being Giardia/Cryptosporidium cysts/

oocysts. The second procedure is to categorize the first step as the

``total number of cysts and/or oocysts per 100L'' (which would be

equivalent to ``presumptive'') and the second step as the ``total

number of cysts and/or oocysts with internal structures.'' The

terminology ``with internal structures'' could be used if at least one

internal structure is identified as being Giardia/Cryptosporidium

cysts/oocysts.

The rationale for considering the two steps as presumptive and

confirmed is: (1) Some algal and yeast cells recovered with this

procedure cross-react with the protozoan monoclonal antibodies used,

(2) many algae and other particles autofluoresce and thereby confuse

the analyst, and (3) depending upon the criteria that will be used for

defining level of treatment requirements in the interim ESWTR, use of

the terminology ``confirmed'' may reduce the number of false positives

and thereby not lead to excessive levels of treatment to achieve the

desired health risk goal. However, the use of these terms is somewhat

inaccurate in that it diminishes the importance of the total count

(i.e., the presumptive test). The confirmed test only reflects those

particles where internal structures can be specifically observed, which

may represent only a small fraction of the cysts/oocysts on the slide.

EPA requests comment on which terminology is most suitable for

referring to the two steps.

Other methods for the assay of Giardia and Cryptosporidium are

currently being developed. One of these assays (the electrotation

assay) is based on the observation that particles in a rotating

electric field also rotate if the frequency is right. In addition to

this assay, other potential assays for the protozoa include polymerase

chain reaction and flow cytometry. The Agency requests comment about

the most appropriate means for incorporating new and easier analytical

methods for Giardia and Cryptosporidium into the ICR.

The method for viruses, as revised, is in Appendix D of the

proposed rule. This method relies on a most probable number technique

using BGM tissue culture monolayers, with cytopathic effect (CPE) as

the sole enumeration endpoint. Attendees at the workshop considered

plaque-forming units (PFU) as an endpoint, but rejected it. Although

the PFU endpoint can be determined without the use of a microscope,

unlike the CPE endpoint, it may not be as sensitive as CPE, i.e., use

of CPE should result in greater virus densities. The workshop members

determined that sensitivity was more important than precision in

quantitation for comparing virus and protozoan data to determine the

appropriateness of using Giardia and possibly Cryptosporidium as the

primary target organism(s) for defining adequacy of treatment.

Clostridium perfringens. If EPA decides to require systems to

monitor Clostridium perfringens, as was discussed in Section IIIA3

above, the Agency would also specify a method for this bacterium. The

Agency believes that the most appropriate method is a membrane filter

procedure using M-CP medium (Bisson and Cabelli, 1979), possibly as

modified by Armon and Payment (1988). The Agency solicits comment on

whether this method is most suitable for monitoring Clostridium

perfringens. The Agency notes that this organism must be grown under

strict anaerobic conditions (i.e., without oxygen).

Coliphage. If EPA decides to require the monitoring of somatic

coliphages and/or male-specific coliphage, as was discussed in Section

IIIA3, the Agency believes that the most appropriate method is a simple

agar overlay procedure. For somatic phage testing, the Agency believes

that the most suitable host is E. coli C. The Agency solicits comment

on whether this procedure and host are most suitable for monitoring the

somatic coliphage. The Agency also seeks comment, with data, on what

bacterial host is most suitable for monitoring male-specific

coliphages. The method for sample collection, sample processing, and

assay for somatic and male-specific coliphage is presented in Appendix

D of the proposed rule.

EPA requests comment on the appropriateness of the above methods.

7. Laboratory Approval

General. EPA is developing a program for approving laboratories to

analyze the pathogens that would be monitored under this rule. This

program would ensure that these laboratories are competent to perform

the analyses. Analytical skill is especially important for the

difficult and sophisticated processing and analyses specified for the

total culturable viruses and Giardia and Cryptosporidium. Another

prominent reason for approving laboratories is to ensure that

laboratory procedures are as standardized as possible for uniform data

comparison among systems.

Currently, EPA has a laboratory certification program for drinking

water analyses. All laboratories that analyze drinking water samples to

determine compliance with MCLs must be certified by EPA or the State,

as specified by 40 CFR 142.10(b)(4) and 141.28. Under this program, EPA

certifies the principal State laboratory and, with certain exceptions

(see 40 CFR 142.10), each State certifies all drinking water

laboratories within the State. Laboratories certified to perform

analysis for coliforms under the Total Coliform Rule would be approved

to analyze for total coliforms, fecal coliforms, and E. coli under the

ICR without further action. The current program does not address

pathogens.

Rather than broaden the present laboratory certification program to

include Giardia, Cryptosporidium, and the viruses, EPA believes that it

would be more appropriate to develop a separate program and to

differentiate the two programs by using the term laboratory

``approval'' instead of ``certification'' to refer to laboratories

performing pathogen analyses required by the ICR. The rationale for

this approach is that (1) EPA expects that only a small number of

laboratories will be qualified to perform analyses for the protozoa and

viruses because of the complexity of the methods, (2) few States and

EPA Regions are currently able to certify laboratories for the

pathogens of interest, and (3) the short time constraints for

implementing this rule and the short-term nature of the sampling (up to

18 months) do not provide time for a full certification program.

Nevertheless, EPA is proposing to use several major elements of the

current certification program in its program to ``approve''

laboratories for pathogen analysis, including performance evaluation

(PE) samples, training, and on-site evaluations. If an interim or long-

term ESWTR were to require some systems to monitor the same pathogens

as those specified by the ICR, then the laboratory approval criteria

would probably be incorporated into the drinking water laboratory

certification program.

Performance evaluation samples. Under the laboratory approval

program proposed herein, a laboratory would need to analyze

satisfactorily a set of PE samples to become approved and subsequent

sets of PE samples (e.g., 6, 12, 18 months) to maintain approval.

Workshop participants recommended that a set of PE samples for Giardia/

Cryptosporidium consist of (1) a mixture of Giardia cysts and

Cryptosporidium oocysts, (2) a mixture of Giardia cysts and

Cryptosporidium oocysts plus algal cells, and (3) algal cells only

(negative control). According to workshop recommendations, a set of PE

samples for viruses should include virus samples of varying titers

(concentrations) that the laboratory would process as if they were

filter eluates. Currently, EPA is developing a PE sample program

intended to satisfy these recommendations.

Training. In addition to PE samples, at least one principal analyst

in each laboratory would need to complete an EPA-specified training

course or meet the requirements of equivalent training, as defined by

the Agency. Although EPA has not yet defined ``equivalent training'',

the Agency is considering an approach involving a training video or an

apprenticeship with an expert. EPA is developing two training courses--

one in Giardia/Cryptosporidium analysis, and the other in environmental

virus analysis. Each of these courses would also include training in

sample collection.

On-site evaluation. EPA is also proposing to require a laboratory

to pass an on-site evaluation before receiving approval. The EPA

Regional Administrator would be the ultimate approval authority. The

Agency would develop criteria for determining whether an individual has

the necessary expertise to conduct the intended tests.

The Agency has drafted a laboratory approval manual that lists the

specific criteria that an on-site evaluator would examine. These

criteria are based on workshop recommendations. This manual, which is

available in the Water Docket, includes a number of certification

criteria from Chapters III and V of EPA's laboratory certification

manual (USEPA, 1990). For example, as part of the on-site evaluation,

the certification officer would ensure that the laboratory has prepared

and is using a written laboratory Quality Assurance Plan. This plan is

described in EPA's laboratory certification manual (Chapter III). Some

draft criteria pertaining to the qualifications of laboratory personnel

are indicated below.

For Giardia and Cryptosporidium analysis:

Technician: This person performs at the bench level and

is actively involved in collecting samples, extracting filters, and/or

processing the filter eluent for Giardia/Cryptosporidium analysis. The

technician must have two years of college (full time) in life sciences

or a related field.

Analyst: This person must have two years of college (full

time) in the life sciences or a related field and have at least three

months experience in examining indirect fluorescent antibody stains

under the microscope.

Principal Analyst/Supervisor: This person is a qualified,

experienced microbiologist with a minimum of a B.A./B.S. degree in

microbiology or a closely related field. The principal analyst must

have completed the ICR protozoan training course (mentioned above) or

have equivalent experience, as approved by EPA.

For virus analysis:

Technician: This person extracts the filter and processes

the sample, but does not perform tissue culture work. The technician

must have at least three months experience in filter extraction of

virus samples and sample processing.

Analyst: This person performs at the bench level and is

involved in all aspects of the analysis, including sample collection,

filter extraction, sample processing, and assay. The analyst must have

two years of college (full time) in the life sciences or at least six

months of bench experience in cell culturing and animal virus analyses.

Principal Analyst/Supervisor: This person is a qualified,

experienced microbiologist who oversees the entire analysis. The

individual must have a B.A./B.S. degree in the life sciences with three

years experience in cell culture and animal virus analyses. This

individual must have completed the ICR environmental virology training

course or have equivalent experience, as approved by EPA.

Because of the tight time constraints and the limited number of

national experts capable of participating in on-site evaluations, EPA

proposes to give highest priority in evaluating those laboratories

(e.g., commercial, academic, utility, State) that (1) have been

analyzing Giardia and Cryptosporidium or virus samples for at least one

year, (2) have nationally recognized experts in protozoan or virus

analyses, or (3) have the technical capability, capacity, and

willingness to analyze at least four samples/month under the ICR

requirements for Giardia and Cryptosporidium or viruses.

Laboratory capacity. If, following the beginning effective date of

this rule, a system cannot locate an approved laboratory to analyze its

water samples for the indicated pathogens, the system would be required

to notify EPA in writing (see Section III.C). EPA will inform the

system which laboratories are available for performing the requisite

analysis, or when new approved laboratories become available to do such

analysis.

EPA solicits comment on the approach above for approving

laboratories and, more broadly, on the most appropriate means for

ensuring that laboratories performing the pathogen analyses are

competent. Laboratories wishing to become approved for doing these

analyses should contact ICR Laboratory Coordinator, USEPA, Office of

Ground Water and Drinking Water, Technical Support Division, 26 West

Martin Luther King Drive, Cincinnati, Ohio 45268, for an application

form to initiate the approval process.

8. Quality Assurance

Sample collection. For the collection of samples for pathogens, the

laboratory would document that each sample collector, either from the

laboratory or the system, is properly trained. Without such

documentation, the laboratory would not proceed with analyzing the

system's samples. EPA encourages approved laboratories to provide

adequate training, if needed, not only to laboratory sample collectors,

but to individuals at client water systems who collect their own

samples for pathogens. Other criteria for sampling are included in the

draft laboratory approval manual mentioned in Section 7, above.

Data reporting. EPA proposes to require a laboratory to submit data

results to both the Agency and the client system for the pathogens. The

water system would also be required to submit the same data results to

the Agency. By receiving and comparing both data submissions, EPA can

reduce reporting errors. EPA would require that systems report data in

a computer-readable form; in addition, systems serving at least 100,000

people would be required to report data in an EPA-specified electronic

format (see Section III.B6 for more discussion). EPA encourages systems

serving 10-100,000 people to also submit data using the electronic

format.

EPA also proposes to require a laboratory, when the laboratory

submits pathogen data to the Agency, to include its results on the most

recent set of PE samples for that pathogen. This quality assurance

criterion would allow EPA to assess the quality of that data,

especially if the data appear to be atypical or equivocal.

B. Stage 2 Disinfection By-Products Rule

1. Need for Additional Data

When drinking water is disinfected, the organic material and

bromide that are naturally present in the water react with the

disinfectant to form hundreds of DBPs. Only a small subset of these

chemicals have been identified due to the complexities of measuring

them. Many of them are not stable, so they decompose during the

sampling or analytical process. Others are polar and so are not easily

extracted from the water for further analysis.

Most of the DBPs that can be measured in drinking water (i.e.,

there are analytical techniques available to detect them) are

byproducts from the use of chlorine. However, there is limited

occurrence information on even these DBPs, so the extent of exposure

cannot be estimated. Only a subset of them have been studied to

determine whether exposure to them presents a risk to health.

Several DBPs were included on the 1991 Drinking Water Priority List

(56 FR 1470; January 14, 1991), as candidates for future regulations.

During development of the proposed Stage 1 D/DBP Rule, the Negotiating

Committee did not believe there were adequate data available to address

most of the DBPs on the Priority List, so MCLs were recommended for a

subset of the Priority List DBPs (trihalomethanes [THMs], haloacetic

acids [HAAs], chlorite and bromate). The Stage 1 D/DBP Rule would

address the ``other'' DBPs in two ways: 1) EPA would assume that

control of other Priority List DBPs would occur if systems could meet

the MCLs for THMs and HAAs; and 2) EPA would require some surface water

systems using conventional treatment to implement optimized coagulation

to remove as much organic material as possible before disinfection,

thereby minimizing the formation of all DBPs. Total organic carbon

(TOC) was designated as the surrogate for the organic precursor

material removed during optimized coagulation.

Many members of the Negotiating Committee expressed concern on the

adequacy of data to support the use of surrogate limits such as TOC for

inclusion in the Stage 1 regulatory criteria. The lack of field data

led the Negotiating Committee to base its decisions on the Stage 1 D/

DBP Rule using a water treatment plant model to predict DBP

concentrations resulting from various changes in treatment practices.

The THM and HAA compliance monitoring requirements being considered

for proposal in the Stage 1 D/DBP Rule were modeled after the

requirements of the current Total Trihalomethane (TTHM) Rule (44 FR

68624, November 1979). Some members of the Negotiating Committee were

concerned that quarterly monitoring for THMs and HAAs would not

accurately reflect consumer exposure to DBPs. An under-prediction of

consumer exposure would be especially serious if research indicated

there were short-term adverse health effects from exposure to DBPs.

Field data were not available to assess the spatial and seasonal

variability of DBP concentrations within distribution systems. Data

were also lacking concerning the usefulness of surrogates, such as

total organic halide (TOX), as tools for reducing compliance monitoring

costs.

As a result of the above uncertainties, the Negotiating Committee

strongly recommended that additional information be collected and

analyzed to assist in the development of a Stage 2 D/DBP Rule. Field

data are needed to: (1) Characterize source water parameters that

influence DBP formation, (2) determine the concentrations of DBPs in

drinking water, (3) refine models for predicting DBP formation based on

treatment and water quality parameters, and (4) establish cost-

effective monitoring requirements that are protective of the public

health. Today's proposed rule would provide EPA with the data necessary

to accomplish the above tasks.

2. Monitoring and Reporting Requirements and Rationale

The rule would require all community and nontransient, noncommunity

systems serving at least 100,000 persons to: (1) Perform the monitoring

summarized in Table III.1-.2 and (2) report treatment plant operational

data specified in Table III.6. Treatment plants that use alternate

disinfectants (chloramines, ozone, or chlorine dioxide) or hypochlorite

solutions would also be required to perform monitoring for DBPs that

are of particular concern for the disinfectant being used. Community

and nontransient, noncommunity systems that use groundwater not under

the direct influence of surface water and serve between 50,000 and

99,999 persons would be required to conduct monthly monitoring for

total organic carbon (TOC) in water entering the distribution system.

Table III.1.--Sampling Points for All Systems

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

Sampling point Analyses\1\ Frequency

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

Treatment plant influent.. pH, alkalinity, turbidity, Monthly.

temperature, calcium and

total hardness, TOC,

UV254, bromide, and

ammonia.

Treatment plant influent Optional oxidant demand Monthly.

(optional for waters with test.

high oxidant demand due

to the presence of

inorganics).

Treatment plant influent.. TOX....................... Quarterly.

After air stripping....... Ammonia................... Monthly.

Before and after pH, alkalinity, turbidity, Monthly.

filtration. temperature, calcium and

total hardness, TOC, and

UV254.

At each point of pH, alkalinity, turbidity, Monthly.

disinfection\2\. temperature, calcium and

total hardness, TOC, and

UV254.

At end of each process in Disinfectant residual\3\.. Monthly.

which chlorine is applied.

After filtration (if THMs, HAAs(6), HANs, CP, Quarterly.

chlorine is applied prior HK, CH, and TOX.

to filtration).

Entry point to pH, alkalinity, turbidity, Monthly.

distribution system. temperature, calcium and

total hardness, TOC,

UV254, and disinfectant

residual\3\.

Entry point to THMs, HAAs(6), HANs, CP, Quarterly.

distribution system. HK, CH, TOX, and SDS\4\.

4 THM Compliance THMs, HAAs (6), HANs, CP, Quarterly.

Monitoring Points in HK, CH, TOX, pH,

Distribution System (1 Temperature, Alkalinity,

sample point will be Total Hardness and

chosen to correspond to Disinfectant Residual\3\.

the SDS sample,\4\ 1 will

be chosen at a maximum

detention time, and the

remaining 2 will be

representative of the

distribution system).

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

\1\TOC is total organic carbon. UV254 is absorbance of ultraviolet light

at 254 nanometers. THMs are chloroform, bromodichloromethane,

dibromochloromethane, and bromoform. HAAs(6) is mono-, di-, and

trichloroacetic acid; mono- and di- bromoacetic acid; and

bromochloroacetic acid. HANs are dichloro-, trichloro-, bromochloro-,

and dibromo- acetonitrile. CP is chloropicrin. HK is 1,1-

dichloropropanone and 1,1,1- trichloropropanone. CH is chloral

hydrate. TOX is total organic halide. SDS is the simulated

distribution system test.

\2\For utilities using ozone or chlorine dioxide, Tables III.4 and

III.5, respectively, show additional monitoring requirements at this

sampling point.

\3\Free chlorine residual will be measured in systems using free

chlorine as the residual disinfectant; total chlorine residual will be

measured in systems using chloramines as the residual disinfectant.

\4\The SDS (simulated distribution system test) sample will be stored in

such a manner that it can be compared to the results from one of the

distribution system sampling points. This distribution system sampling

point will be selected using the following criteria: 1) No additional

disinfectant added between the treatment plant and this point, 2)

Approximate detention time of water is available, and 3) No blending

with water from other sources. The SDS sample will be analyzed for

THMs, HAAs(6), HANs, CP, HK, CH, TOX, pH and disinfectant residual.

\5\Five THM samples.

Monitoring of source water quality. EPA would require all community

and nontransient noncommunity water systems serving at least 100,000

persons to conduct monthly monitoring of the raw water entering each

treatment plant for pH, alkalinity, turbidity, temperature, calcium and

total hardness, total organic carbon (TOC), ultraviolet absorbance at

254 nm (UV254), bromide ion, and ammonia. If the raw water were to

contain a sufficiently high concentration of inorganic chemicals (i.e.,

hydrogen sulfide, iron, manganese) to cause a high oxidant demand, then

the system would be encouraged to monitor for this inorganic oxidant

demand at the same frequency. Systems would collect samples from the

plant influent after water from multiple sources is blended. The

sampling point would be before the first treatment step to characterize

the chemical quality of the water being treated. A system that uses

ground water not under the direct influence of surface water and with

multiple wells in the same aquifer would only be required to collect

raw water samples from representative wells in the two aquifers serving

the largest portion of the system's population.

The above parameters were selected because they influence the

quantity and chemical character of the DBPs formed when the

disinfectant is added to the water. High oxidant demand water should be

characterized because the availability of the disinfectant for reaction

with organic material to form DBPs will depend on the amount of

disinfectant that is consumed by inorganic chemicals. EPA solicits

comments on the definition of high oxidant demand water and the type(s)

of measurements necessary to characterize it.

Monthly sampling at the treatment plant influent would provide an

estimate of the variability in raw water quality. EPA would use data

from this portion of the rule to characterize source water parameters

that influence DBP formation.

Monitoring within the treatment plant. EPA would require systems

serving at least 100,000 people to monitor for most of the same

parameters at several points within the treatment plant. These

requirements are summarized in Table III.1. Samples from representative

points before and after the filters collected on a monthly basis would

be measured for pH, alkalinity, turbidity, temperature, calcium and

total hardness, TOC, and UV254. These measurements would provide

data on changes in water quality between the plant influent and the

last filtration step. Of particular importance are data on how the

organic precursor material (as represented by TOC and UV254) is

removed prior to and through filtration.

Monthly monitoring of the same parameters (pH, alkalinity,

turbidity, temperature, calcium and total hardness, TOC, and

UV254) would be required at each point of disinfection. These data

are critical, because most data now available for comparing these

variables with DBP concentrations are based on source water data. Most

utilities do some treatment of the water prior to the addition of

disinfectant, so source water measurements do not accurately reflect

the quality of the water when the disinfectant is added. These data

would provide a more accurate determination of how these parameters

influence DBP formation.

Disinfectant residuals would be measured monthly at the end of each

treatment process in which chlorine is applied. Free and total chlorine

residual would be reported if free chlorine is used as the

disinfectant; total chlorine residual would be reported if ammonia is

added in combination with chlorine or when sufficient ammonia is

present in the source water that breakpoint chlorination is not

achieved. These data combined with information on the applied

disinfectant dosages and contact times (from the plant operational data

discussed in the next section) would give a more accurate picture on

DBP formation, because the chlorine or chloramine demand of the water

can be estimated. Part of this demand is reflected in the formation of

DBPs.

If a water plant practices air stripping to remove volatile organic

compounds (VOCs) from the raw water prior to the addition of a

disinfectant and the raw water contains ammonia, then a monthly sample

collected immediately following the air stripper and analyzed for

ammonia would be required. Air stripping might change the concentration

of ammonia, and an accurate concentration of ammonia is necessary to

determine DBP formation.

EPA would also require systems serving at least 100,000 people to

analyze samples from the entry point to the distribution system

monthly. The monitoring would consist of pH, alkalinity, turbidity,

temperature, calcium and total hardness, TOC, UV254, and

disinfectant residual.

Systems are already monitoring for many of the parameters listed

above, either to comply with other drinking water regulations or for

operational considerations. Therefore, the additional costs of

providing monthly data would not be excessive for these parameters.

The monthly data from the treatment plants would provide EPA with

the necessary information to conduct two analyses essential for the

development of the Stage 2 D/DBP Rule: (1) The variability in source

water quality and treatment operation and its impacts on the parameters

that influence the formation of DBPs, and (2) when the data are

combined with the DBP data described below, EPA will have a better

understanding of how water quality and treatment practices influence

DBP formation. This understanding would allow EPA to refine models for

predicting DBP formation based on treatment and water quality

parameters and thus to further clarify the interrelationships between

disinfectant concentrations and DBPs under field conditions.

EPA would require community and nontransient, noncommunity water

systems that use only ground water not under the direct influence of

surface water and serve between 50,000 and 99,999 people to analyze TOC

samples monthly from the entry points to the distribution system.

Additional monitoring for chlorination by-products. EPA would

require monitoring for specific chlorination by-products quarterly to

fulfill three objectives: (1) To relate water quality and treatment

practices to DBP formation, (2) to determine the concentration of DBPs

in drinking water, and (3) to establish cost effective monitoring

requirements that are protective of public health. The Agency would

require analysis for the following chlorination by-products:

chloroform, bromodichloromethane, dibromochloromethane, bromoform,

monochloroacetic acid, dichloroacetic acid, trichloroacetic acid,

monobromoacetic acid, dibromoacetic acid, bromochloroacetic acid,

trichloroacetonitrile, dichloroacetonitrile, bromochloroacetonitrile,

dibromoacetonitrile, 1,1- dichloropropanone, 1,1,1-trichloropropanone,

chloropicrin, and chloral hydrate. Each time a DBP sample is collected,

the system would also be required to measure and report pH,

temperature, alkalinity, and disinfectant residual. Free chlorine

residual would be measured in systems using free chlorine as the

disinfectant. Total chlorine residual would be measured at sampling

points after the addition of ammonia, because the residual disinfectant

would be chloramines.

To relate DBP formation to water quality and treatment practices,

EPA would require systems to monitor the above DBPs at the following

locations: (1) At a representative point immediately after the last

filtration step (if chlorine is applied prior to the filters), (2) at

the entry point to the distribution system, and (3) at a TTHM

compliance monitoring sampling point in the distribution system which

can be related to a simulated distribution system (SDS) sample. This

distribution system sampling point would be selected using the

following criteria: (1) No additional disinfectant is added to the

water between entry to the distribution system and the sampling point,

(2) the approximate detention time of the water is available, and (3)

there is no blending with water from other treatment plants. A sample

would also be collected at the entry point to the distribution system

and incubated at a time and temperature corresponding to the

distribution system sample. This SDS sample would be analyzed for the

same DBPs as the distribution system sample and it would provide a

measure of DBP formation under controlled conditions. Data from SDS

samples would also be evaluated as a cost-effective alternative to

distribution system compliance monitoring.

The concentration of chlorination by-products would be determined

by requiring the utilities to conduct quarterly monitoring at four

points in the distribution system using the same criteria for sampling

point selection as specified in the THM Rule. One sample would be taken

from a point representing a maximum detention time in the system. The

sample point with the highest THM concentrations would meet this

criterion. The second sample would correspond to the SDS sampling point

described above. The remaining two points would be representative of

the distribution system. All four sampling points would be routine

sampling points for TTHM compliance monitoring. This regimen minimizes

the sampling costs, since additional sampling points are not required.

It also provides a link between the measurements made for this rule and

the historical TTHM compliance monitoring data for each system. Systems

that have two or more treatment plants serving the same distribution

system would only be required to collect four DBP samples in the

distribution system.

Six quarters of DBP monitoring would provide EPA with information

concerning the spatial and seasonal variability of DBPs within

distribution systems. In an effort to evaluate lower cost monitoring

options, EPA would also require systems to monitor total organic halide

(TOX) concentrations at the same sampling points and at the same time

DBP concentrations are measured. Total organic halide (TOX) is an

indicator of the total quantity of dissolved halogenated organic

material present in water. Essentially all of the TOX present in

chlorinated drinking water in the United States is the result of

reactions between chlorine and the organic material and bromide ion

present in the source water. The eighteen chlorination by-products

listed above typically account for less than 50% of the TOX that is

measured in chlorinated drinking water. Since TOX also includes the

halogenated by-products not routinely measured, it might be a better

surrogate of chlorination by-product concentrations than are TTHMs and

THAAs. The TOX analysis of treatment plant influent would also be

required quarterly, because the source water could contain background

concentrations of halogenated organic compounds as a result of chemical

contamination or upstream discharges of chlorinated water. The DBP,

TOX, and surrogate precursor (i.e., TOC and UV254) data will be

evaluated to determine the most cost-effective monitoring requirements

that are protective of public health.

All the samples for the above-named parameters would be collected

as close together in time as feasible (during the same working day if

possible). Samples would be collected during normal plant operating

conditions, when there were no obvious changes in source water quality

due to storm events, chemical spills, etc. The quarterly sampling for

DBPs would be conducted at the same time as the sampling from the

treatment plant(s). The quarterly samples would be collected at a time

when the source water quality and plant operations had been stable for

several days, so that the distribution system sample can be related to

the SDS sample that is collected at the same time.

Additional monitoring required for systems using chloramines. EPA

would require systems serving at least 100,000 people and using

chloramines to analyze for one additional DBP, cyanogen chloride. This

by-product is formed when chlorine reacts with organic material in the

presence of the ammonium ion (Ohya and Kanno, 1985). There are little

data available to assess the occurrence of this compound and the

factors influencing its formation are poorly understood. Therefore,

these data are necessary to determine how the distribution of by-

products would change if utilities switched from free chlorine to

chloramines as the residual disinfectant to meet the MCLs for TTHM and

THAA.

Monitoring for cyanogen chloride would be required quarterly, as

summarized in Table III.2. Only one sample would be required from the

distribution system, because of the analytical complexities of

measuring the compound. By sampling at the entry point to the

distribution system and at a point of maximum detention time, EPA would

be able to assess the concentration range at which this compound

occurs. Cyanogen chloride is very reactive, and would be expected both

to decompose and be produced within the distribution system.

Table III.2.--Additional Sampling Required of Systems Using Chloramines

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

Sampling point Analyses Frequency

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

Entry point to Cyanogen chloride......... Quarterly.

distribution system.

One THM compliance Cyanogen chloride......... Quarterly.

monitoring sample point

representing a maximum

detention time in

distribution system.

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

Additional monitoring required of systems using hypochlorite

solutions. EPA would require systems serving at least 100,000 people

and using hypochlorite solutions for chlorination to perform the

additional monitoring presented in Table III.3. The monitoring would

include quarterly measurements for chlorate in the treatment plant

influent, hypochlorite feedstock solution, and water at the entry point

to the distribution system. Chlorate is a decomposition product found

in hypochlorite feedstock (Lister, 1956; Bolyard, et al., 1992; and

Gordon et al., 1993). Its concentration in the drinking water would not

be expected to change in the distribution system unless additional

hypochlorite solution was added, because it is not a DBP from chlorine

reactions under drinking water conditions. Quarterly monitoring of the

hypochlorite stock solution to assess the factors that influence

chlorate formation (pH, storage temperature, and hypochlorite ion

concentration) would also be required. These data would allow EPA to

assess the significance of chlorate ion resulting from the use of

hypochlorite solutions. EPA anticipates chlorate would be regulated as

part of the Stage 2 DBP Rule.

Table III. 3.--Additional Sampling Required of Systems Using

Hypochlorite Solutions

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

Sampling point Analyses Frequency

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

Treatment plant influent.. Chlorate.................. Quarterly.

Hypochlorite stock pH, temperature, free Quarterly.

solution. residual chlorine, and

chlorate.

Entry point to Chlorate.................. Quarterly.

distribution system.

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

Additional monitoring required of systems using ozone. EPA would

require systems serving at least 100,000 people and using ozone in

their treatment process to perform the additional monitoring listed in

Table III.4. The ozone contactor influent would be monitored monthly

for parameters that influence formation of by-products: pH, alkalinity,

turbidity, temperature, calcium and total hardness, TOC, UV254,

bromide, and ammonia. The ozone residual would be measured in the

contactor effluent and immediately prior to filtration. These data

would be combined with the operational data and the DBP data to better

understand and predict DBP formation.

Table III.4.--Additional Sampling Required of Systems Using Ozone

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

Sampling point Analyses Frequency

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

Ozone contactor influent.. pH, alkalinity, turbidity, Monthly.

temperature, calcium and

total hardness, TOC,

UV254, bromide, and

ammonia.

Ozone contactor influent.. Aldehydes\1\ and AOC/ Quarterly.

BDOC\2\.

Ozone contactor effluent.. Ozone residual............ Monthly.

Ozone contactor effluent.. Aldehydes\1\ and AOC/ Quarterly.

BDOC\2\.

Before filtration......... Ozone residual............ Monthly.

Entry point to Bromate................... Monthly.

distribution system.

Entry point to Aldehydes\1\ and AOC/ Quarterly.

distribution system. BDOC\2\.

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

\1\The aldehydes to be included in this analysis are: formaldehyde,

acetaldehyde, butanal, propanal, pentanal, glyoxal, and methyl

glyoxal. Measurement of other aldehydes is optional.

\2\Submission of data for assimilable organic carbon (AOC) or

biodegradeable organic carbon (BDOC) is optional.

Water systems using ozone would also be required to monitor for

specific DBPs that are known to be formed as the result of oxidation

reactions. The contactor influent, contactor effluent and water from

the entry point to the distribution system would be monitored on a

quarterly basis for aldehydes. Utilities would also be encouraged to

voluntarily measure assimilable organic carbon (AOC) or biodegradeable

dissolved organic carbon (BDOC) at the same sampling points and at the

same frequency and voluntarily submit the data. The concentration of

bromate would be monitored on a monthly basis at the entry point to the

distribution system. The concentration of bromate is not expected to

increase in the water after it leaves the treatment plant.

Additional monitoring required of systems using chlorine dioxide.

EPA would require systems serving 100,000 people and using chlorine

dioxide in their treatment process to conduct the additional monitoring

listed in Table III.5. Parameters that influence the formation of by-

products would be measured on a monthly basis at sampling point(s)

prior to each application of chlorine dioxide. The analyses would

include: pH, alkalinity, turbidity, temperature, calcium and total

hardness, TOC, UV254, and bromide.

Table III.5--Additional Sampling Required of Systems Using Chlorine

Dioxide

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

Sampling point Analyses Frequency

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

Treatment plant influent.. Chlorate.................. Quarterly.

Before each chlorine pH, alkalinity, turbidity, Monthly.

dioxide application. temperature, calcium and

total hardness, TOC,

UV254, and bromide.

Before first chlorine Aldehydes\1\ and AOC/ Quarterly.

dioxide application. BDOC\2\.

Before application of pH, chlorine dioxide Monthly.

ferrous salts, sulfur residual, chlorite,

reducing agents, or GAC. chlorate.

Before downstream chlorine/ Aldehydes\1\ and AOC/ Quarterly.

chloramine application. BDOC\2\.

Entry point to Chlorite, chlorate, Monthly.

distribution system. chlorine dioxide

residual, bromate.

Entry point to Aldehydes\1\ and AOC/ Quarterly.

distribution system. BDOC\2\.

3 distribution system chlorite, chlorate, Monthly.

sampling points (1 near chlorine dioxide

first customer, 1 in residual, pH, and

middle of distribution temperature.

system, and 1 at a

maximum detention time in

the system).

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

\1\The aldehydes to be included in this analysis are: formaldehyde,

acetaldehyde, butanal, propanal, pentanal, glyoxal, and methyl

glyoxal. Measurement of other aldehydes is optional.

\2\Submission of data for AOC or BDOC is optional.

The by-products of particular concern from the use of chlorine

dioxide are chlorite and chlorate. Since the application of ferrous

salts or sulfur reducing agents changes the concentrations of these by-

products, utilities would be required to monitor for chlorite and

chlorate prior to and following each of these treatment processes.

Monitoring would also be required before and after granular activated

carbon (GAC) filtration. These data would provide a better

understanding of the formation and control of these two by-products and

would allow the development of predictive models for use in development

of the Stage 2 D/DBP Rule.

Very little data are available concerning the chlorite and chlorate

concentrations generally present in drinking water as a result of

chlorine dioxide use. Therefore, utilities would be required to monitor

for these by-products at the entry point to the distribution system and

at three sites within the distribution system. The concentrations of

chlorite and chlorate are expected to change as the water is

distributed through the system, so distribution system samples are

needed to assess the magnitude of the changes. One sample would be

collected near the first customer; another sample would be collected at

a point representing the maximum detention time in the distribution

system and the last sample would be collected at a point representative

of the average consumer.

These water systems would also be required to monitor the chlorine

dioxide residual concentrations, pH and temperature at the above

sampling points. Of particular concern is the possible re-formation of

chlorine dioxide in the distribution system as a result of reactions

between chlorite and chlorine. Since chlorine dioxide and its by-

products may pose acute health risks, monitoring for them would be

required on a monthly basis. The proposed Stage 1 D/DBP Rule may

require daily monitoring for chlorine dioxide at the point of entry

into the distribution system and monthly monitoring for chlorite at

three points in the distribution system.

Because low levels of chlorate have been reported in source water

(Bolyard, et al., 1993; and Gordon, et al., 1993), EPA would also

require systems using chlorine dioxide to monitor the treatment plant

influent monthly for chlorate. This monitoring would provide data to

assess the relative amounts of chlorate from source water versus the

amount produced as the result of chlorine dioxide use.

EPA would also require systems using chlorine dioxide to perform

quarterly monitoring for several oxidation by-products, because there

is a small amount of data indicating their presence as the result of

chlorine dioxide use. Quarterly monitoring for aldehydes would be

required: (1) Before the first chlorine dioxide application in order to

determine background levels from the source waters; (2) before

application of the secondary disinfectant to determine what was

produced by chlorine dioxide; and (3) at the entry point to the

distribution system to evaluate the total level delivered to the

consumers based upon all the treatment processes and disinfectants. EPA

would also encourage systems to voluntarily measure AOC or BDOC at the

same sampling points and at the same frequency and voluntarily submit

the data. The Agency would require systems to report the bromate

concentration present in the sample analyzed for chlorite and chlorate

from the entry point to the distribution system, because there are

limited data indicating that bromate may be formed as a result of

sunlight catalyzed reactions between chlorine dioxide and bromide ion

present in the source water (Zika et al., 1985). This would be an

additional sample, because the measurement of low levels of bromate

(g/L) in the presence of much higher levels of chlorite

(100-1000 g/L) would require special treatment of the sample.

3. Treatment Process Information Collection

Background/justification. EPA proposes collecting treatment process

information as part of this rule to characterize the various forms of

treatment currently being used by treatment plants serving more than

100,000 persons. The treatment process information will be used to

evaluate options available to large water utilities to monitor and

reduce DBP formation. The Water Treatment Plant (WTP) Model

(Harrington, et al., 1992) was used to predict THM and HAA levels in

the development of the Stage 1 D/DBP Rule. The model is available from

the Safe Drinking Water Act Hotline (1-800-426-4791). It uses raw water

quality and treatment process data to predict THM and HAA formation.

The WTP model is calibrated on fewer than 100 bench-, pilot-, and full-

scale studies. This rule would provide a sufficiently large database to

upgrade the model to include additional processes, predict other DBPs,

and better calibrate the model based on hundreds of plant experiences.

The process data would be coupled with the water quality data

described in Tables III.1 through III.5 to assess how treatment impacts

precursor removal; how treatment affects the formation of THMs, HAAs

and other DBPs; and how parameters like TOX and SDS compare to

distribution system compliance parameters. Relationships between the

process data and water quality data collected under this rule would be

evaluated to help define Stage 2 requirements of the D/DBP Rule and to

better evaluate and refine prediction models that will be used for the

Stage 2 D/DBP Rule development.

Specific Process Information. The treatment plant information and

unit processes listed in Table III.6 and the water quality data

described in previous sections will provide the information necessary

to develop predictions between raw water quality, treatment conditions,

precursor removal, and DBP formation. EPA selected the parameters

listed to characterize the unit process for use in developing the

predictions and Stage 2 D/DBP Rule development. For example,

coagulation parameters are needed for evaluation of efficiencies to

better define the impact of enhanced coagulation for precursor (TOC)

control. The depth of the filter is needed to evaluate the feasibility

of adding GAC to the filter for precursor removal. The complete process

train details are needed to evaluate the feasibility and costs of

treatment changes being considered for DBP control. The list does not

include every possible water treatment process parameter, but does

include the parameters that would be used to characterize the treatment

practices for the purpose of this monitoring rule.

Table III.6.--Treatment Plant Information

Utility information:

Utility Name

Mailing Address

Contact Person & Phone Number

Public Water Supply Identification Number FRDS (PWSID)

Population Served

Plant information:

Name of plant

Design flow (MGD)

Annual minimum water temperature (C)

Annual maximum water temperature (C)

Hours of operation (hours per day)

Source water information:

Name of source

Type of source (One of the following)

1River

2Stream

3Reservoir

4Lake

5Ground water under the direct influence of surface water

6Ground water

7Spring

8Purchased from Utility Name, FRDS PWSID

9Other

Surface water as defined by SWTR (TRUE/FALSE)

Monthly Average Flow of this Source (MGD)

Upstream sources of microbiological contamination

Wastewater plant discharge in watershed (yes/no)

Distance from intake (miles)

Monthly average flow of plant discharge (MGD)

Point source feedlots in watershed (yes/no)

Distance of nearest feedlot discharge to intake (miles)

Non-point sources in watershed

Grazing of animals (yes/no)

Nearest distance of grazing to intake (miles)

Plant influent (ICR influent sampling point):

Monthly average flow (MGD)

Monthly peak hourly flow (MGD)

Flow at time of sampling (MGD)

Plant effluent (ICR effluent sampling point):

Monthly average flow (MGD)

Monthly peak hourly flow (MGD)

Flow at time of sampling (MGD)

Sludge treatment:

Monthly average solids production (lb/day)

Installed design sludge handling capacity (lb/day)

General process parameters:

The following data will be required for all unit processes:

Number of identical parallel units installed

Number of identical parallel units in service at time of sampling

The following parameters will be required for all unit processes except

chemical feeders:

Design Flow per unit (MGD)

Liquid volume per unit (gallons)

Tracer study flow (MGD)

T50 (minutes)

T10 (minutes)

Presedimentation basin:

Surface loading at design flow (gpm/ft2)

Chemical feeder:

Type of feeder (one of the following)

1Liquid

2Gas

3Dry

Capacity of each unit (lb/day)

Purpose (one or more of the following)

1Coagulation

2Coagulation aid

3Corrosion control

4Dechlorination

5Disinfection

6Filter aid

7Fluoridation

8Oxidation

9pH adjustment

10Sequestration

11Softening

12Stabilization

13Taste and odor control

14Other

Chemical feeder chemicals (one of the following):

Alum

Anhydrous ammonia

Ammonium hydroxide

Ammonium sulfate

Calcium hydroxide

Calcium hypochlorite

Calcium oxide

Carbon dioxide

Chlorine dioxide--acid chlorite

Chlorine dioxide--chlorine/chlorite

Chlorine gas

Ferric chloride

Ferric sulfate

Ferrous sulfate

Ozone

Polyaluminum chloride

Sodium carbonate

Sodium chloride

Sodium fluoride

Sodium hydroxide

Sodium hypochlorite

Sodium hexametaphosphate

Sodium silicate

Sulfuric acid

Zinc orthophosphate

Other

Notes:

1. The above list is intended to be a comprehensive list of chemicals

used at water treatment plants. If the name of a chemical does not

appear in the list then ``Other Chemical'' information will be

requested.

2. Formulas and feed rate units will be included in data reporting

software.

Monthly average feed rate based on inventory (mg/L) Feed rate at time

of sampling (mg/L)

Other chemical:

Note:

In addition to Chemical Feeder information the following will be

required for any chemical not included in the Chemical Feeder list of

chemicals.

Trade name of chemical

Formula

Manufacturer

Rapid mix:

Type of mixer (one of the following)

1Mechanical

2Hydraulic jump

3Static

4Other

If mechanical: horsepower of motor

If hydraulic: head loss (ft)

If static: head loss (ft)

Flocculation basin:

Type of mixer (one of the following)

1Mechanical

2Hydraulic

3Other

If mechanical: Mixing power (HP)

If hydraulic: head loss (ft)

Sedimentation basin:

Loading at Design Flow (gpm/ft2)

Depth (ft)

Filtration:

Loading at Design Flow (gpm/ft2)

Media Type (one or more of the following)

1Anthracite

2GAC

3Garnet

4Sand

5Other

Depth of top media (in)

If more than 1 media: Depth of second media (in)

If more than 2 media: Depth of third media (in)

If more than 3 media: Depth of fourth media (in)

If GAC media: Carbon replacement frequency (months):

Water depth to top of media (ft)

Depth from top of media to bottom of backwash trough (ft)

Backwash Frequency (hours)

Backwash volume (gallons)

Contact basin (Stable liquid level):

Baffling Type (one of the following as defined in SWTR guidance

manual)

1Unbaffled (mixed tank)

2Poor (inlet/outlet only)

3Average (Inlet/Outlet and intermediate)

4Superior (Serpentine)

5Perfect (Plug flow)

Clearwell (Variable liquid level):

Baffling Type (one of the following as defined in SWTR guidance

manual)

1Unbaffled (mixed tank)

2Poor (inlet/outlet only)

3Average (Inlet/Outlet and intermediate)

4Superior (Serpentine)

5Perfect (Plug flow)

Minimum liquid volume (gallons)

Liquid volume at time of tracer study (gallons)

Ozone contact basin:

Basin Type

1Over/Under (Diffused O3)

2Mixed (Turbine O3)

Number of Stages

CT (min mg/L)

EPA requests comments on the design and operating parameters to be

reported for ozone contact basins.

Tube settler:

Surface loading at design flow (gpm/ft2)

Tube angle from horizontal (degrees)

Upflow clarifier:

Design horse power of turbine mixer (HP)

Surface loading at design flow (gpm/ft2)

Special Equipment (none, one, or more of the following)

1Lamella plates

2Tubes

Plate settler:

Surface loading at design flow (gpm/ft2)

DE filter:

Surface loading at design flow (gpm/ft2)

Precoat (lb/ft3)

Bodyfeed (mg/L)

Run length (hours)

Granular activated carbon:

Empty bed contact time at design flow (minutes)

Design regeneration frequency (days)

Actual regeneration frequency (days)

Membranes:

Type (one of the following)

1Reverse osmosis

2Nanofiltration

3Ultrafiltration

4Microfiltration

5Electrodialysis

6Other

Name of Other type

Membrane type (one of the following)

1Cellulose acetate and derivatives

2Polyamides

3Thin-film composite

4Other

Name of other membrane type

Molecular weight cutoff (gm/mole)

Configuration (one of the following)

1Spiral wound

2Hollow fiber

3Tube

4Plate and frame

5Other

Name of other configuration

Design flux (gpd/ft2)

Design pressure (psi)

Purpose of membrane unit (one or more of the following)

1Softening

2Desalination

3Organic removal

4Other

5Contaminant removal--name of contaminant

Percent recovery (%)

Operating pressure (psi)

Air stripping:

Packing height (ft)

Design liquid loading (gpm/ft2)

Design air to water ratio

Type of packing (Name)

Nominal size of packing (inch)

Operating air flow (SCFM)

Adsorption clarifier:

Surface loading at design flow (gpm/ft2)

Dissolved air flotation:

Surface loading at design flow (gpm/ft2)

Slow sand filtration:

Surface loading at design flow (gpd/ft2)

Ion exchange:

Purpose (one or more of the following)

1Softening

2Contaminant removal

Contaminant name

Media type (Name)

Design exchange capacity (equ/ft3)

Surface loading at design flow (gpm/ft2)

Bed depth (ft)

Regenerant Name (one of the following)

1Sodium Chloride (NaCl)

2Sulfuric Acid (H2SO4)

3Sodium Hydroxide (NaOH)

4Other

If other: Name and formula

Operating regeneration frequency (hr)

Regenerant concentration (%)

Regenerant Used (lb/day)

Other treatment:

Name

Purpose

Design Parameters

EPA will be working with the industry to develop the software to

collect this process information as described in the following section.

Utilities would use the data collection software to input the process

data once at the beginning of the monitoring period with monthly

updates of the operating data and any treatment modifications.

EPA requests comments on the completeness of Table III.6 to

describe treatment plant configurations and the specific design

parameters for the unit processes that would be relevant to Stage 2 D/

DBP rule development and future model development for predicting DBPs.

Is all the requested information essential? Are more efficient

mechanisms available than those proposed herein for obtaining the

desired information? Will the treatment plant information requested be

adequate for developing models by which to predict the ability of

utilities to achieve various potential regulatory criteria under Stage

2 (e.g., DBP and TOX occurrence levels in the distribution system)?

Will the treatment plant information required for systems serving

100,000 or more people be adequate for developing predictive models of

DBP formation for systems serving less than 100,000 people? What

additional information, if any, would be important to obtain to predict

the formation of DBPs in systems serving less than 10,000 people? If

additional information is needed, what mechanisms should be used for

obtaining it? For example, would any survey techniques of

representative systems be useful for obtaining this information?

Data collection software design. Since the collection of DBP

occurrence data and source water quality data must be combined with

information about the treatment processes, EPA proposes using data

collection software as a mechanism for obtaining the monitoring data

and treatment plant process information necessary for developing the

Stage 2 D/DBP Rule. The software would capture information about source

water quality, treatment plant design, unit processes, chemical

dosages, and the monitoring results listed in Tables III.1-III.6. EPA

would provide technical assistance for use of the data collection

software.

To capture both water quality data and process information from

each plant, the data collection software and database would be designed

to handle various treatment configurations including split flow,

process parameters relevant to each configuration, and water quality

monitoring data described in earlier sections.

EPA would provide each utility a diskette containing the data

collection software. The software would generate screen driven data

entry forms that are customized for the water utility depending on the

treatment process configuration entered by the utility. The water

quality parameters listed in Tables III.1 through III.5 and the results

of the microbiological monitoring would also be entered by the utility.

The water utility would only enter monitoring results pertinent to its

system. Table III.6 lists the unit process choices that would be used

to develop the process train for a given water treatment plant. The

computer program would be designed to prompt the user for the process

parameters based on the process choices selected. For example, a plant

using only chlorine for disinfection would not see prompts for chlorine

dioxide residual, bromate, or chlorite on its data entry screen.

The software will determine such details as where sampling points

should generally be located and which water quality parameters should

be measured. The user would have the option of printing a series of

data forms to be used as a guide in identifying sample point locations,

requesting laboratory analysis, and gathering design and operation

parameters. The software will be designed in data segments and will

save data to a monthly data file on a hard drive or diskette. The

utility will send data to EPA as described in the following section.

4. Database Development

The proposed procedure would entail each PWS collecting the data on

a computer diskette provided by EPA using the data collection software,

sending the data via modem or by diskette to a database coordinator,

having the data reviewed for correctness by an engineer or scientist

familiar with water treatment, loading the data into a master database,

having the data analyzed periodically throughout the monitoring period,

generating interim reports, and having the database in final usable

form for Stage 2 D/DBP Rule development shortly after the conclusion of

the sixth quarter monitoring period. Any interested party would have

access to the data at various points in time during the collection

period. EPA would provide technical assistance throughout the data

collection and reporting process.

EPA proposes that a personal computer with an MS-DOS operating

system be used for data entry. EPA would provide the ICR data

collection software to the utilities for data collection. The utilities

would provide the personal computer. The software will have many built

in features to guide the user through the process train configuration

and data input. In addition, EPA intends to make technical assistance

available, if needed, to help assure the quality of information

provided.

The output from the data collection software would be monthly data

files in ASCII format. Data files on diskette would be mailed to EPA

and transferred to the master data base. Data files transferred via

modem would be sent using telecommunication software supplied by the

utility. EPA requests comment on the use of diskettes, modem or other

means for data reporting.

Design of the database, its input/output mechanisms, and its output

formats would be considered before start-up of the monitoring effort.

The output would target the requirements being considered for the Stage

2 D/DBP Rule and the Enhanced SWTR. Examples of the many questions the

output would address are: (1) What is the national distribution of

bromide, TOC, etc., i.e., the factors that affect DBP formation? (2)

What is the distribution of HAAs, chloral hydrate, etc. in distribution

system waters? (3) What treatment processes and operating conditions

are associated with minimum DBP levels? (4) What levels of bromate form

in ozonation plants under different conditions?

Testing data collection and transfer. Before monitoring begins, EPA

would need to beta test the ICR data collection software for

transferring data from the utility to a master database to identify

unforeseen problems with the data collection procedure. Therefore, the

Agency's schedule for beta testing must have enough lead time to modify

the process, if needed, before monitoring begins. EPA intends to

conduct the data collection software beta testing with the cooperation

of a small number of utilities with diverse characteristics. The master

database and its data manipulation and output procedures would also be

beta tested to identify unforeseen problems with the data handling

procedures after the data are reported to EPA.

Frequency of reporting. EPA would require systems to submit data to

the Agency two months after monitoring begins and thereafter monthly.

Periodic reporting would allow EPA to review the data and resolve

problems associated with data collection and submission, and also to

quicken the pace of regulatory development of the interim and long-term

ESWTRs.

Data availability. EPA would make raw (unanalyzed) data available

to interested organizations and individuals periodically throughout the

monitoring period via electronic transfer. EPA proposes that the data

be made available after the first two quarters' raw data have been

verified, and for every 6 months of data thereafter following the

verification of that data until the conclusion of the monitoring

period. This access would be a ``read only'' mode.

EPA would make analyzed data available in summary form. The

analyzed data would be grouped by source water type, utility size, type

of treatment, distribution of DBPs, distribution of TOC, treatment

effectiveness, etc. These data would be used in developing the interim

and long-term ESWTR and the Stage 2 D/DBP rule.

5. Analytical Methods

Approved methods. Analytical methods that are currently approved

for monitoring purposes under other drinking water regulations would be

approved for use under this rule. These include the parameters: (1) pH;

(2) alkalinity; (3) turbidity; (4) temperature; (5) calcium hardness;

(6) free residual chlorine; (7) total residual chlorine; (8) chlorine

dioxide residual; (9) ozone residual; (10) chloroform; (11)

bromodichloromethane; (12) dibromochloromethane; and (13) bromoform.

Analytical methods for several of the above named parameters have

also been updated in the 18th edition of Standard Methods for the

Examination of Water and Wastewater for the Examination of Water and

Wastewater. These include: (1) pH; (2) alkalinity; (3) turbidity; (4)

temperature; (5) calcium hardness; (6) free residual chlorine; (7)

total residual chlorine; (8) chlorine dioxide residual; and (9) ozone

residual. The updated versions of these methods would also be approved

for compliance monitoring under this rule.

In addition to the methods currently approved for monitoring

purposes under other drinking water regulations and their most recent

versions, approved methods for the remainder of the parameters that

must be measured for this rule are listed in Table III.7. The methods

are published and contain descriptions of the methodology and

information on the precision and accuracy of the methods.

EPA is proposing one new method (EPA Method 551) for trihalomethane

(chloroform, bromodichloromethane, dibromochloromethane, and bromoform)

monitoring under this rule. EPA is also soliciting comment on whether

use of this method should also be approved for compliance with the

monitoring requirements under the Trihalomethane rule [44 FR 68264,

November 29, 1979].

Monitoring for the six haloacetic acids (HAAs) would be done using

EPA Method 552.1 or an expanded version of Method 6233 B which is

published in the 18th edition of Standard Methods. Bromochloroacetic

acid is not listed as an analyte in the published version of Method

6233 B, because an analytical standard was not commercially available

when the method was first developed. The feasibility of including it in

Method 6233 B has been demonstrated (Barth and Fair, 1992), and it will

be added to the method during the next revision.

Method 6233 B is undergoing revision for the 19th edition of

Standard Methods, so EPA proposes that a draft version be made

available to laboratories performing HAA analyses for this monitoring

rule.

EPA would require laboratories to use EPA Method 551 for measuring

trichloroacetonitrile, dichloroacetonitrile, bromochloroacetonitrile,

dibromoacetonitrile, 1,1-dichloropropanone, 1,1,1-trichloropropanone,

and chloropicrin. The use of pentane instead of methyl-tertiary-butyl

ether (MTBE), the solvent described in the method, would be permissible

when analyzing for these analytes and for the THMs.

Chloral hydrate (CH) would also be measured using EPA Method 551,

but its concentration would be determined by analyzing a separate

sample from the one collected for the other 551 analytes. CH requires a

different dechlorinating agent than the other DBPs included in the

method. The THMs can also be measured in the chloral hydrate sample.

MTBE must be used as the extracting solvent when measuring CH.

EPA Method 551 specifies that the pH of the sample be adjusted to

between 4.5 and 5.0 when the sample is collected, to prevent base-

catalyzed hydrolysis of several of the analytes. Sample stability has

been demonstrated for 14 days when this technique is used in the

laboratory. However, field application of this preservation technique

(i.e., titration) has not been tested and may not be practical. EPA

proposes that the samples be collected without adjusting the pH and

that the laboratories be required to extract the samples within 24-48

hours of sample collection. This requirement would result in a negative

bias in the data for several of the analytes, with the bias increasing

as the pH of the samples increases. EPA solicits comments on this

approach or suggestions on alternative approaches.

Chlorate, chlorite, bromide, and bromate would be measured using

EPA Method 300.0. Laboratories would be permitted to use alternate

eluents (e.g., borate eluent) or sample cleanup or concentration

techniques in order to lower the detection limit for bromate, as long

as the quality assurance criteria specified in the method are met.

EPA is aware that the above method may not be sensitive enough to

provide quantitative data for bromate at concentrations g/

L. Some laboratories may be able to detect bromate in samples at

concentrations as low as 5 g/L, but the data will not be

precise enough to be used for making decisions on how treatment

practices and source water characteristics influence bromate formation.

Since the Stage 1 D/DBP Rule may propose a maximum contaminant level

goal (MCLG) of zero for bromate, it is important to extend the

quantitation for bromate to as low a concentration as possible during

this information collection process.

One of EPA's laboratories has the capability to measure bromate at

concentrations of g/L using a selective anion concentration

technique prior to ion chromatography analysis (Hautman, D.P., Nov.

1992). EPA does not think this new technique could be readily

transferred to laboratories doing routine analyses, because the

required instrumentation is not commercially available and the

technique is complex and time consuming. Therefore, in order to obtain

low level bromate measurements, EPA is proposing that utilities be

required to collect duplicate samples and to send one sample from each

duplicate set to EPA. EPA could then obtain more sensitive quantitation

to better characterize bromate formation as a function of water quality

treatment characteristics. EPA would use the data generated by

utilities to evaluate the ability of laboratories to accurately and

precisely measure bromate near the anticipated MCL of 10 g/l

in the Stage 1 D/DBP rule that was agreed to by the Negotiating

Committee. EPA would be responsible for obtaining the required analyses

using the new technique. EPA solicits comments on this approach for

obtaining low level bromate measurements.

Cyanogen chloride (CNCl) concentrations would be monitored using a

modified version of EPA Method 524.2. This compound is not listed in

the method, but feasibility has been demonstrated (Flesch and Fair,

1988). Cyanogen chloride is unstable, so laboratories would be required

to perform the analysis within 24-48 hours of sample collection.

Samples for CNCl analysis must be dechlorinated using ascorbic acid.

EPA is aware of one other technique for measuring CNCl. A headspace

analytical technique using gas chromatography with electron capture

detection was recently described in the literature (Xie and Reckhow,

1993). It can also be used to measure cyanogen bromide which may be

preferentially formed when the source water contains bromide ion. EPA

solicits comments on whether this technique should be used to generate

data for this monitoring rule. Use of the technique would be contingent

upon preparation of a written protocol for performing the analysis

including specific quality control requirements. The protocol would be

published in the ICR DBP Analytical Methods Guidance Manual.

A method for the analysis of aldehydes in source water and drinking

water is being written for the 19th edition of Standard Methods. The

methodology involves the use of O-(2,3,4,5,6-pentafluorobenzyl)-

hydroxylamine (PFBHA) as a derivatizing agent. PFBHA reacts with low

molecular weight carbonyl compounds, including aldehydes, in aqueous

solutions to form the corresponding oximes. These derivatives are

extractable with organic solvents and can be measured using gas

chromatography with either electron capture (ECD) or selective ion

monitoring-mass spectrometry (SIM-MS) detection (Glaze et al., 1989;

Cancilla et al., 1992). EPA proposes that the draft version of the

method be used by laboratories performing aldehyde analyses for this

monitoring rule.

Analyses for aldehydes are usually begun immediately or within 24

to 48 hours after sample collection, because a preservation technique

has not been demonstrated. EPA proposes that all aldehyde analyses for

this rule be initiated within 48 hours of sample collection. EPA

solicits comments on alternative approaches.

Total organic halide (TOX) would be monitored using Standard Method

5320 B. All samples for this monitoring rule would be dechlorinated and

acidified at the time of collection.

Total organic carbon (TOC) would be monitored using Standard Method

5310 C (persulfate-ultraviolet oxidation) or 5310 D (wet-oxidation).

The samples must not be filtered prior to analysis. Turbid samples

would be diluted using organic free water in order to remove

interferences from high concentrations of particulate matter.

EPA is aware of recent advances in the measurement of TOC using

high temperature catalytic oxidation (Benner and Hedges, 1993; Kaplan,

1992). The instrumentation is commercially available and is being used

in some drinking water laboratories. Published data suggest the new

technique may be slightly more effective than the proposed methods in

oxidizing refractory organic material. If this is true, then results

produced using the new technique would indicate higher TOC levels than

would be measured using the proposed methods, when samples contained

refractory organic material. The methodology has not been evaluated by

EPA and it is not published in a reference text such as Standard

Methods or an EPA Methods Manual. EPA solicits comments on whether (or

under what conditions) the use of this new oxidation technique should

be permitted for monitoring under this rule.

No written method exists for measuring ultraviolet absorbance at

254 nm (UV254). EPA proposes that a protocol be developed by a

workgroup composed of persons familiar with techniques currently being

used to study precursor removal. The protocol would be distributed to

all laboratories that generate UV254 data for this rule and its

use would be required. The protocol would also be published in the ICR

DBP Analytical Methods Guidance Manual. The protocol will specify

sample filtration and pH adjustment procedures.

Simulated distribution system (SDS) samples would be incubated at

the same temperature and pH as the distribution system for a reaction

time comparable to the estimated detention time of the distribution

system sampling point selected for comparison purposes. The general

protocol is described in the 18th edition of Standard Methods under

Method 5710 E. Exact details of how the SDS samples would be handled

will be specified in the ICR DBP Analytical Methods Guidance Manual.

Since the temperature and incubation time of the SDS samples will be

utility specific, EPA will recommend that the utility incubate the

sample for the specified time period. The pH and disinfectant residual

would be measured at the end of the incubation period. The sample would

then be poured into sample bottles containing the appropriate

dechlorinating agents and preservatives and sent to the laboratory for

analysis. This procedure would alleviate concern over laboratory

logistics in dealing with many SDS samples requiring different

incubation temperatures and times. The SDS sample would be analyzed for

chloroform, bromodichloromethane, dibromochloromethane, bromoform,

monochloroacetic acid, dichloroacetic acid, trichloroacetic acid,

monobromoacetic acid, dibromoacetic acid, bromochloroacetic acid,

chloral hydrate, trichloroacetonitrile, dichloroacetonitrile,

bromochloroacetonitrile, dibromoacetonitrile, 1,1- dichloropropanone,

1,1,1-trichloropropanone, chloropicrin, total organic halide, pH, and

disinfectant residual.

Table III.7--Analytical Methods Approved for Monitoring Rule

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

Methodology

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

Analyte 40 CFR Standard

reference\1\ EPA method method\2\

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

pH............... 141.74(a)(7), 4500-H+

141.89(a).

Alkalinity....... 141.89(a)........ 2320 B

Turbidity........ 141.22(a), 180.1\3\ 2130 B

141.74(a)(4).

Temperature...... 141.74(a)(6), 2550 B

141.89(a).

Calcium hardness. 141.89(a)........ 200.7\4\ 3111 B, 3120 B,

3500-Ca D

Free residual 141.74(a)(5)..... 4500-Cl D, 4500-

chlorine. Cl F, 4500-Cl

G, 4500-Cl H

Total residual 141.74(a)(5)..... 4500-Cl D, 4500-

chlorine. Cl E, 4500-Cl

F, 4500-Cl G,

4500-Cl I

Chlorine dioxide 141.74(a)(5)..... 4500-ClO2 C,

residual. 4500-ClO2 D,

4500-ClO2 E

Ozone residual... 141.74(a)(5)..... 4500-O3 B

Chloroform....... 141 Subpt C, App. 502.2\5\, 524.25,6, 5517,8 ................

C.

Bromodichlorometh 141 Subpt C, App. 502.2\5\, 524.25,6, 5517,8 ................

ane. C.

Dibromochlorometh 141 Subpt C, App. 502.2\5\, 524.25,6, 5517,8 ................

ane. 3.

Bromoform........ 141 Subpt C, App. 502.2\5\, 524.25,6, 5517,8, ................

C.

Monochloroacetic ................. 552.1\6\ 6233 B

acid.

Dichloroacetic ................. 552.1\6\ 6233 B

acid.

Trichloroacetic ................. 552.1\6\ 6233 B

acid.

Monobromoacetic ................. 552.1\6\ 6233 B

acid.

Dibromoacetic ................. 552.1\6\ 6233 B

acid.

Bromochloroacetic ................. 552.1\6\ 6233 B\9\

acid.

Chloral Hydrate.. ................. 551\7\ ................

Trichloroacetonit ................. 5517,8 ................

rile.

Dichloroacetonitr ................. 5517,8 ................

ile.

Bromochloroaceton ................. 5517,8 ................

itrile.

Dibromoacetonitri ................. 5517,8 ................

le.

1,1- ................. 5517,8 ................

Dichloropropanon

e.

1,1,1- ................. 5517,8 ................

Trichloropropano

ne.

Chloropicrin..... ................. 5517,8 ................

Chlorite......... ................. 300.0\10\ ................

Chlorate......... ................. 300.0\10\ ................

Bromide.......... ................. 300.0\10\ ................

Bromate.......... ................. 300.0\10\ ................

Cyanogen Chloride ................. 524.2\6\ ................

Aldehydes........ ................. ........................................................ draft method

submitted to

19th Edition

Total Organic ................. ........................................................ 5320 B

Halide (TOX).

Total Organic ................. ........................................................ 5310 C, 5310 D

Carbon.

UV absorbance at ................. ........................................................ ................

254 nm (method

described in

preamble--protoc

ol will be

developed).

Simulated ................. ........................................................ 5710 E

Distribution

System Test

(SDS).

Total Hardness... ................. ........................................................ 2340 B, 2340 C

Ammonia.......... ................. ........................................................ 4500-NH3 D, 4500-

NH3 F

Oxidant Demand/ ................. ........................................................ 2350 B, 2350 C,

Requirement 2350 D

(optional).

AOC/BDOC ................. ........................................................ 9217 B/

(optional).

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

\1\Currently approved methodology for drinking water compliance monitoring is listed in Title 40 of the Code of

Federal Regulations in the sections referenced in this column.

\2\Standard Methods for the Examination of Water and Wastewater, 18th ed., American Public Health Association,

American Water Works Association, Water Pollution Control Federation, 1992.

\3\``Methods of Chemical Analysis of Water and Wastes,'' EPA Environmental Monitoring Systems Laboratory,

Cincinnati, OH EPA-600/4-79-020, Revised March 1983.

\4\Methods for the Determination of Metals in Environmental Samples. Available from National Technical

Information Service (NTIS), U.S. Department of Commerce, Springfield, Virginia, PB91-231498, June 1991.

\5\USEPA, ``Methods for the Determination of Organic Compounds in Drinking Water,'' EPA/600/4-88/039, PB91-

231480, National Technical Information Service (NTIS), December 1988 (revised July 1991).

\6\USEPA, ``Methods for the Determination of Organic Compounds in Drinking Water--Supplement II,'' EPA/600/R-92/

129, PB92-207703, NTIS, August 1992.

\7\USEPA, ``Methods for the Determination of Organic Compounds in Drinking Water--Supplement I,'' EPA/600/4-90-

020, PB91-146027, NTIS, July 1990.

\8\Pentane may be used as the extraction solvent for this analyte, if the quality control criteria of the method

are met.

\9\This analyte is not currently included in the method. However, Barth and Fair (1992) present data

demonstrating it can be added to the method. The method is being revised for the 19th edition of Standard

Methods and it will include this analyte.

\10\USEPA, ``Methods for the Determination of Inorganic Substances in Environmental Samples,'' EPA/600/R/93/100-

, August 1993.

Laboratory approval. EPA recognizes that the usefulness of the data

generated as the result of this rule depends on the ability of

laboratories to reliably analyze the disinfectants, disinfection by-

products and other parameters. EPA has a laboratory certification

program for drinking water analyses. All laboratories that analyze

drinking water samples to determine compliance with drinking water

regulations must be certified by EPA or the State, as specified by 40

CFR 142.10(b)(4) and 141.28. Under this program, EPA certifies the

principal State Laboratory and, with certain exceptions (see 40 CFR

142.10), each State certifies drinking water laboratories within the

State.

Laboratories currently certified to perform analyses using EPA

Methods 501.1, 501.2, 502.2 or 524.2 for TTHMs or volatile organic

compound (VOC) would be approved to analyze for chloroform,

bromodichloromethane, dibromochloromethane, and bromoform using the

same analytical method under the ICR without further action. In

addition, all persons or laboratories already approved by EPA or the

State for analyzing alkalinity, pH, temperature, turbidity,

disinfectant residual, and calcium hardness analyses would be approved

to perform these measurements under the ICR without further action.

Parties approved by a State for calcium hardness analyses using

Standard Methods 3500-Ca D would also be approved for total hardness

measurements using Standard Method 2340 C under this rule. Parties

approved by a State for calcium hardness analyses using Standard

Methods 3111 B or 3120 B would also be approved for total hardness

measurements using Standard Methods 2340 B under this rule. Parties

approved by a State for pH measurements using Standard Methods 4500-

H+ would also be approved for ammonia measurements using Standard

Method 4500-NH3 F under this rule.

For other parameters to be monitored under this rule, EPA proposes

to develop a separate laboratory evaluation process apart from the

drinking water laboratory certification program. A new process is being

proposed for several reasons: 1) few States and EPA Regions are

currently able to certify laboratories for the new analytes of interest

in this rule and it is unlikely that they could develop the capacity in

the time frame to implement this rule; 2) the short-term nature of the

monitoring period may not warrant a full certification program, since

monitoring would not be required for many of the analytes after the 18

month monitoring period; and 3) large numbers of laboratories are not

needed to perform the DBP-related monitoring, because the monitoring

requirements only affect approximately 300 systems.

Under the new process, EPA would require laboratories to meet

specific criteria (described below) before approving them to perform

monitoring of the new analytes covered in the DBP portion of the ICR.

Laboratories would be approved on a method-by-method basis.

Laboratory approval criteria would consist of the following

elements:

(1) The laboratory would be required to contact ICR Laboratory

Coordinator, USEPA, Office of Ground Water and Drinking Water,

Technical Support Division, 26 West Martin Luther King Drive

Cincinnati, Ohio, 45268, for an application form to initiate the

approval process. The form would request information on the laboratory

personnel, facilities, analytical methods/protocols in use for ICR

analyses, current State certification status, and laboratory capacity

to process DBP/ICR samples. The laboratory could submit a copy of the

most recent application form it had filed with the State and the most

recent copy of the State's on-site visit report, in lieu of completing

portions of the EPA form. The laboratory could also provide EPA with

copies of its PE data for ICR analytes in the three most recent PE

studies. The PE data must have been generated using the methods for

which the laboratory is seeking approval.

(2) EPA would require the laboratory to use the analytical methods

or protocols specified in this rule and contained in the ICR DBP

Analytical Methods Guidance Manual. A laboratory that desires to use

EPA Method 551 for trihalomethane analyses under this rule would have

to apply for approval under this process, even though it may be

certified for THM compliance monitoring using a different method.

(3) EPA would require the laboratory to have a Quality Assurance

(QA) Manual specific to this rule. Guidance for preparing this manual

will be provided in the ICR DBP Analytical Methods Guidance Manual.

(Examples of the types of information that should be included in the QA

Manual are: (1) Laboratory organization; (2) sampling handling

procedures; (3) analytical method references and quality control; and

(4) data handling and reporting procedures. The QA manual would also

include or reference the standard operating procedure (SOP) for each

analytical method/protocol in use for ICR analyses.) The QA manual must

be available for review, if requested.

(4) EPA would require the laboratory to conduct an initial

demonstration of capability (IDC) and method detection limit (MDL)

determinations for each analysis for which it requests approval for

this monitoring rule, and submit these data to the Agency. EPA would

require laboratories to determine the MDL according to the procedure

outlined in 40 CFR part 136 Appendix B, with additional guidance being

given in the ICR DBP Analytical Methods Guidance Manual. The manual

will also outline minimum requirements for performing the IDC

determinations. Minimum performance criteria for each method IDC and

MDL would also be specified in the ICR DBP Analytical Methods Guidance

Manual based on what is feasible to achieve and what is necessary to

obtain the data quality objectives of this rule. (EPA is proposing that

the minimum performance criteria for IDCs and MDLs be based on IDC and

MDL data obtained from a minimum of three laboratories that are

experienced in conducting each specific analysis.)

(5) If the laboratory does not have a history of successfully

analyzing PE samples for the ICR analytes using the methods specified

in this rule, then EPA would require the laboratory to satisfactorily

analyze two PE samples, if available, for each of the methods it uses

to generate data for this monitoring rule. Historical performance in PE

studies could be applied toward meeting this requirement if the

laboratory had satisfactory performance on at least two of three PE

samples analyzed by the method in question and the last PE sample was

satisfactorily analyzed. EPA proposes that satisfactory performance on

PE samples be defined as achieving within 40% of the study

mean concentration for this rule. EPA considers this criteria as

reasonable relative to what laboratories should be able to achieve in

order to meet the objectives of the rule.

PE samples are currently available for THMs, six HAAs, chloral

hydrate, bromate, chlorite, and chlorate. EPA plans to conduct special

PE studies for the ICR which will also include trichloroacetonitrile,

dichloroacetonitrile, bromochloroacetonitrile, dibromoacetonitrile,

1,1- dichloropropanone, and 1,1,1-trichloropropanone, bromide, TOC, TOX

and UV254 PE samples. A PE sample for chloropicrin will not be

required because laboratory performance using EPA Method 551 can be

assessed using the data from the other method analytes.)

EPA is considering using a third party (independent organization)

to review the application form, IDC, MDL, and PE study data and conduct

an on-site inspection, if necessary. Based upon the third party's

assessment of the laboratory, EPA would approve laboratories. EPA

solicits comment on this process or other options such as laboratories

paying for the review by a third party.

Implementation of the laboratory approval process would begin upon

promulgation of the ICR and it would extend until the end of the first

quarter period of monitoring, following the beginning effective date of

this rule, but possibly later, if EPA determines that insufficient

laboratories through that date had been approved. No additional

laboratories would be evaluated after this period unless there was not

adequate laboratory capacity to handle the monitoring required by the

DBP ICR. If additional capacity was required, then new laboratories

would be evaluated until the necessary capacity was reached.

EPA proposes that a list of ``approved'' laboratories be made

available to all the utilities required to monitor for DBPs, their

precursors and surrogates. The list would be distributed directly to

the utilities, as well as to each EPA Regional Office and State Primacy

Agency. The list would also be available for public distribution from

EPA.

EPA would monitor the performance of ``approved'' laboratories

throughout the ICR monitoring period by requiring the laboratories to:

(1) periodically (either quarterly or semiannually, depending on

feasibility) analyze PE samples; and (2) report specific quality

control (QC) data with the analytical results from the monitoring

samples. Maintaining laboratory ``approval'' throughout the ICR

monitoring period would be contingent upon successfully meeting the

acceptance criteria for the PE samples and the quality control data.

The required QC data and performance criteria would be included in the

ICR DBP Analytical Methods Guidance Manual. (An overview is presented

in Section 6 of this preamble under Analytical Data.) Laboratories that

do not pass a PE sample would receive another PE sample before the next

regularly scheduled EPA PE study, to demonstrate successful completion

of corrective action. EPA, either directly or by third party, would

provide technical assistance to laboratories that had initially been

``approved'' and then develop problems, if the operation of such

laboratories is necessary to maintain the lab capacity to fulfill the

requirements of this rule.

Laboratory capacity. EPA recognizes that obtaining the necessary

laboratory capacity to complete the DBP monitoring required by this

rule may be difficult. For this reason, as for pathogen monitoring, EPA

is proposing a period within which monitoring could be initiated and

completed. Systems would be required to conduct microbial and DBP

monitoring simultaneously, beginning as soon as EPA approved

laboratories could be identified for conducting both analysis. However,

TOC monitoring would not be delayed because these data are required to

assess which systems would need to do bench or pilot scale testing of

precursor removal technologies. Therefore, all TOC monitoring must

begin by [insert date 3 months following the promulgation of this

rule]. EPA also proposes to delay or omit the monitoring of certain

analytes, if their inclusion would cause undue delay in the start of

monitoring for the remainder of the analytes. Monitoring would not be

omitted for the following parameters: (1) Trihalomethanes; (2)

haloacetic acids; (3) bromate; (4) chlorite; (5) chlorate; (6) total

organic halide; (7) total organic carbon; and (8) bromide. EPA requests

comments on this issue.

EPA is concerned about the feasibility of developing laboratory

capacity for measuring cyanogen chloride (CNCL) and aldehydes. In

addition, EPA is concerned about its ability to evaluate laboratories

that may develop capabilities for measuring these analytes, because PE

samples will not be available. These issues are described below.

EPA has several concerns about the measurement of CNCl. The first

issue is one of safety. Analytical standards must be prepared from pure

CNCl, because pure CNCl is the only commercially available material.

The worker who prepares the stock liquid CNCl standards must be

experienced in the preparation of liquid standards from gases. Due to

the toxicity of the compound, special precautions must be taken to

ensure the safety of the worker. Few laboratories that specialize in

analyses of drinking water are equipped to prepare CNCl standards from

pure gas.

One solution to the safety issue would be for EPA to provide liquid

CNCl standards to laboratories that perform this analysis for the ICR.

EPA is not certain that development of liquid CNCl standards is

feasible within the time frame of this rule. In addition, EPA is

concerned about the ability to evaluate the performance of laboratories

that conduct this analysis.

EPA does not have the resources to develop performance evaluation

(PE) samples for CNCl or aldehydes in time to meet the requirements of

this regulation. An alternative approach to compare laboratory

performance would be to conduct round robin interlaboratory studies

using whole volume samples. Due to issues concerning the stability of

CNCl and aldehydes and limited data on the intralaboratory performance

of the methods, the results from round robin interlaboratory studies

would be very difficult to interpret.

One of EPA's laboratories has the capability to measure CNCl in

water using EPA Method 524.2 and to measure aldehydes using the PFBHA

methodology. Utilities could be required to send all samples for CNCl

and aldehyde analyses to EPA. Having one laboratory perform all these

analyses for the ICR would eliminate the data variability that results

from multiple laboratory analyses, thus producing more precise data.

Greater precision would make it easier to determine how treatment

practices and source water characteristics influence CNCl and aldehyde

formation. EPA solicits comment on this approach for obtaining CNCl and

aldehyde measurements.

6. Quality Assurance

The integrity of the DBP monitoring database is contingent upon

accurate and precise analytical data from the samples, accurate plant

process information from each utility, and correct input of the data

into the database. EPA proposes that each utility prepare a Quality

Assurance Project Plan (QAPP) specific for the ICR monitoring. The QAPP

would cover the entire project starting with the objectives of the

project, through the sampling strategy and procedures, laboratory

procedures and analytical methods and finally, the data handling and

reporting processes. Guidance for preparing it would be provided in an

ICR Guidance Manual.

Sampling. The sampling for this rule would primarily be done by the

system. Each system has its own sampling regime and protocol for the

currently regulated contaminants. Sampling for the unregulated DBPs is

more complex, and will require greater coordination with the analytical

laboratory. As a result, EPA intends to develop a sampling guidance

manual to describe the proper sampling techniques for use in complying

with this rule. The manual would describe: (1) Sample containers; (2)

sampling techniques; (3) required preservatives and dechlorinating

agents; (4) sample shipping conditions; and (5) sample holding times

and conditions. Samplers would be required to follow the specifications

outlined in the manual. EPA solicits comments concerning alternative

mechanisms for ensuring consistency in the sampling aspects of the

study.

Analytical data. The analytical data for this rule may be generated

by many laboratories. As a result, the data will have variable

characteristics such as: (1) Detection level; (2) precision; and (3)

bias. As a first step to ensuring data comparability, EPA would require

laboratories to use the specific analytical methods or protocols

outlined in the ICR and described in the ICR DBP Analytical Methods

Guidance Manual. An additional technique that may be employed to assist

in data comparability is to require all laboratories to obtain their

primary standards (i.e., standards which laboratories use to calibrate

their instruments) from the same source. EPA is evaluating the cost of

providing primary standards for the major ICR analytes to laboratories

``approved'' for performing analyses for the ICR.

In addition, EPA proposes that minimum quality control acceptance

criteria be established for all data that are entered into the DBP

database. A workgroup will establish acceptance criteria for each

parameter being measured based on the data quality objectives necessary

for successfully completing the monitoring study objectives. These

criteria will be included in the ICR DBP Analytical Methods Guidance

Manual. The performance of the method as it is routinely used in

laboratories currently doing the same analysis will be used as a guide

for determining feasibility in meeting the data quality objectives.

Laboratories will be required to: (1) Demonstrate the absence of

interferences from background contamination by analyzing method and/or

shipping blanks, depending upon the method at a specified frequency;

(2) achieve quantitative recovery of surrogate standards that are

spiked into samples for some analytical methods; (3) achieve

quantitative recovery of the internal standard when its use is

specified in the method/protocol; (4) perform a specified minimum

number of duplicate analyses and analyses of fortified samples (or

reagent water, depending upon the analysis) with each batch of samples

processed through the analytical procedure; (5) achieve a specified

level of precision and accuracy for each batch of samples. Where

appropriate, calibration will require a specified number of procedural

standards, as well as periodic verification of quantitation at the

minimum reporting level. The ICR Analytical Methods Guidance Manual

will contain specific criteria for: (1) The quality control (QC)

procedures that must be followed with each analytical method or

protocol; (2) the minimum reporting level for each method/protocol and

a method for demonstrating it (The minimum reporting level, which is

the level at which laboratories will be able to accurately and

precisely measure the analyte, will be higher than the method detection

limit [MDL]); and (3) data quality acceptance criteria for each method/

protocol. The QC procedures and acceptance criteria may be more

stringent than the specifications in the current versions of the

methods based on ICR data quality objectives. Concentrations below the

minimum reporting level specified for each method/protocol will be

reported as ``zero'' in the database. EPA requests comments on the use

of zero in the database to indicate concentrations below the reporting

level, or whether data should be reported as low as the MDL level.

EPA would require laboratories to include the above mentioned QC

data with the analytical results for the samples in the reports they

send to the systems. The Agency would provide systems guidance on how

to evaluate the QC data. Monitoring data that meet the minimum QC

acceptance criteria (as specified in the ICR DBP Analytical Methods

Manual) would be reported to EPA along with a subset of the associated

QC data. The utility would send the QC information and identification

of the laboratories to EPA using the same mechanism as it uses to

report plant process and monitoring data. In some cases, the QC data

for a batch of samples will be shared by two or more utilities (e.g.,

analyses of laboratory fortified blanks). EPA would require both the

laboratory and utility to report to EPA the extraction and analysis

dates for each batch of samples.

The QC data would be entered into the DBP database along with the

analytical data. Computer algorithms will be used to determine if the

data meet the specified QC criteria and the data will be classified as

acceptable or marginally acceptable. Systems would not submit to EPA

data that do not meet the minimum QC criteria. Instead, the utility

will notify EPA of the reason for losing the sample (i.e, breakage,

sample holding time exceeded, laboratory QC out of control, etc.). When

the laboratory fails to consistently meet performance criteria, EPA

would assist the system in finding an alternate laboratory for future

monitoring. EPA would also provide technical assistance, upon request,

either directly or through a contractor, to laboratories who develop

technical difficulties in measuring critical ICR analytes, to maintain

the necessary laboratory capacity and capability to complete the ICR

monitoring. EPA requests comments on the QA/QC criteria for data entry

into the database.

Treatment plant process data. To maintain quality and integrity of

data input, EPA would undertake some level of review of system data.

The Agency would screen the data for proper use of the input software,

proper electronic transfer of data, submission of all required data and

plant operating information, reasonableness and completeness of the

data, consistency with previous reports, etc. EPA requests comment on

how the data review should be conducted.

7. Bench/Pilot Scale Testing

During the negotiation of the D/DBP rule, the Negotiating Committee

agreed to require surface water systems serving greater than 100,000

people and ground water systems serving greater than 50,000 people to

conduct bench or pilot studies on DBP precursor removal, using either

GAC or membrane filtration, unless these systems met certain water

quality conditions or already had such full scale treatment in place.

The purpose of this requirement was twofold: (a)

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National Primary Drinking Water Regulations: Monitoring Requirements for Public Drinking Water Supplies: Cryptosporidium, Giardia, Viruses, Disinfection Byproducts, Water Treatment Plant Data and Other Information Requirements | Frix