United States
             Environmental Protection
             Agency
Office of Water
4603
EPA811-F-96-003
May 1996
&EPA   INFORMATION  COLLECTION  RULE:

             KEY ISSUES



Issue #1: Strategy for Collecting and Using Protozoa Data

One of the major causes of delay between the proposal of the information Collection Rule in
February 1994 and its promulgation in May 1996 was the need to assess the adequacy of the
analytical method to be  used to collect data on Giardia and Cryptosporidium.  Early testing indicated
there were significant questions about the ability of the analytical method (Immunofluorescent
Assay) to produce meaningful data. Nonetheless, negotiators were hopeful that subsequent
evaluation would enable the method to be included in the rule.

EPA conducted extensive testing of the method.  Based on that testing, EPA recognizes that the
method is difficult to run-, has poor recovery, and does not have a high level of precision.  Because
of the method's limitations, EPA will restrict analysis of samples to laboratories which meet
stringent approval criteria.  EPA will also limit the use of the data to developing a national
occurrence data base and national cost impacts of regulatory options. These and other steps EPA
has taken to improve the method and ensure data quality are described more fully below.

         >•  Consultation  with Outside Experts

            In 1994 and 1995, EPA held public meetings to discuss the method,
            possible modifications, and results of performance studies. Important
            recommendations on improving the method emerged from these
            meetings  and were implemented to the extent possible.

         >•  Testing

            Two full rounds of performance studies (method analysis using a single
            source water) were conducted in 1995, as well as a field spiking study
            to show the performance of the method with representative .source
            waters.       .

         >•  Statistical Analysis

            After the  testing was completed, EPA performed an extensive
            statistical analysis to determine minimum  percentage recoveries and
            precision  to meet the objectives for the data. The objectives at the
            time of proposal were to provide EPA with a national occurrence data
            base and  cost estimates for regulatory options for controlling microbes
            and disinfection byproducts, and to provide public water systems with
            site specific information they could use to comply with any future
            rules.
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>•  Narrowed Scope of Objectives

    Based on EPA's statistical analysis, EPA no longer believes the last
    objective, (site-specific information) can be met with the current
    protozoa method.  EPA believes that the objectives of meaningful
    national occurrence data and regulatory impact analyses can be derived
    if laboratories achieve, on  average, greater than an 8% recovery for
    protozoan cysts. .EPA simulation studies indicate that this level of
    laboratory performance should detect protozoa in at least two of
    eighteen monthly samples in at least 60% of the sites where protozoa
    are actually present.  This level of occurrence, with use of a
    statistically-derived adjustment factor for estimating true protozoan
    concentrations from measured values, would enable EPA to estimate
    the number of systems nationally that require different levels of
    treatment to achieve a desired finished water concentration, as might
    be prescribed in the Enhanced  Surface Water Treatment Rule.

>•  Tighten Lab Approval Criteria

    EPA recognizes that, to meet the data quality objective of 8% recovery
    for protozoan cysts, protozoa laboratories will have to meet stringent
    approval criteria to qualify for performing ICR analyses.  These criteria
    include performance evaluation studies, an on-site inspection,
    employment of  at least one principal analyst with extensive experience
    using this  method, and a comprehensive inventory to ensure the
    adequacy  of equipment and personnel.

>•  Narrow Coverage of Rule

    In  order to ensure sufficient laboratory capacity to perform the testing,
    EPA has limited the number of water systems required to conduct
    microbial testing from the  10,000 persons and above contained in the
    proposed rule to 100,000  and  above in the final rule.

>  Supplemental Surveys

    EPA will augment the data collected under the rule with three surveys.
    The first is a survey of 50 utilities serving 100,000 people or more to
    measure Cryptosporidium under even more tightly controlled laboratory
    conditions than can be imposed on laboratories analyzing data under
    the ICR. The second is a survey of 50 utilities serving between 10,000
    and 100,000 people to ensure that data developed on large systems
    can be extrapolated to medium size systems.  The third is a survey of
    systems serving fewer than 10,000 persons to understand differences
    affecting smaller systems. The first and second of these surveys are to
    be conducted in 1997; the third would occur the following year. Only
    data from  the rule which meet the data quality objectives, with the EPA
    survey data, will be used in EPA's analysis.
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The statistical analysis supporting the data quality objectives has been peer reviewed within EPA
and by two outside reviewers. The outside reviewers found no significant problems which would
prevent the analysis from being used to support the data quality objectives established by EPA.
EPA recognizes that much more dialogue and peer review is needed for stakeholders to understand
the analysis and assess their support of it.  EPA is committed to conducting that dialogue during
1996.  EPA is initiating a series of meetings with  stakeholders to discuss issues such as this one
and to  keep stakeholders informed while the Information Collection Rule and the research  program
are underway.

EPA also recognizes that the ultimate usefulness of the data will depend upon: 1) the ability of
laboratories to meet the data quality objectives, and 2) the  comparability of the data generated
under the rule and the surveys to data generated by whichever method is adopted in the Enhanced
Surface Water Treatment'Rule.
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       EPA believes the protozoa method should be included in the Information Collection
       Rule because:

          •  There is a good likelihood it will provide useful data

          •  The more  experience laboratories have with the method, the better their performance
             should be

          •  Through subsequent testing, an adjustment factor may be generated to improve the
             utility of rule-generated protozoan data

          •  There is a public perception that protozoa occurrence is a significant health  issue;
             whatever data can be gathered will help address this concern

          •  The total cost of including it  is less than $5 million of the $130 million estimated for
             the entire rule, with less than $1  million attributed to the incremental inclusion of
             Cryptosporidium over Giardia.
Issue #2: Implementation Schedule

The schedule for implementation of the Information Collection Rule is as follows:

      June 1996:
       August 1996:

       November 1996:
       December 1996:
       February  1997:
EPA mails notice of applicability to utilities expected to be subject to
the rule
Utilities initiate TOC monitoring and begin to prepare their sampling
plans
Utilities submit sampling plans
EPA issues sampling plan decisions
Sampling begins
This schedule is ambitious. While some slippage is possible, EPA is hopeful that most utilities will
begin testing by March so that data are collected during the 1997 spring runoff—a period of
expected high microbial contamination and natural organic content.
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Utilities will report data to EPA on a monthly basis and will have four months from the time of
sampling to conduct the analyses and submit the data.  EPA will then validate the data and they
will become publicly available.

Negotiators envisioned that eight months of data would be sufficient to initiate analysis and identify
appropriate regulatory options for the Enhanced Surface Water Treatment Rule.  EPA plans to issue
a Notice of Availability containing its analysis and choice of regulatory option for the Enhanced
Surface Water Treatment Rule in late 1998.  EPA would receive and process comments on that
notice and then begin preparation of the final rule. The rule would only be promulgated after the
full 18 months of data were received, analyzed, and found to corroborate the analysis  of the first
eight  months. These steps would probably not be completed until the year 2000. (The Enhanced
Surface Water Treatment Rule proposed in July 1994 applied only to systems serving  10,000 or
more  people. An Enhanced Surface Water Treatment Rule covering smaller size systems, and
possible modifications applicable to large systems, would be proposed later.)

Similarly, EPA would analyze  all the data (disinfection byproduct and  microbial monitoring and
treatment technology effectiveness) collected under the rule, as well  as the results of research
conducted to date.  EPA would then publish the results of its analysis in a Notice of Availability.
That notice would likely be published in early 2000.  Discussions regarding the Stage II DBP rule
could begin shortly thereafter.
Issue #3: Implementation of the Research Plan

Negotiators recognized that two  activities were needed to select the appropriate regulatory option
for the Enhanced Surface Water Treatment Rule and to enable meaningful discussion of the Stage II
DBP rule: 1) the Information Collection Rule and 2) the five year, $50 million research program.
The research program was to be  funded jointly by EPA and other research organizations. Utilities
are concerned that they should not be required to spend funds to generate data under the
Information Collection Rule until EPA had initiated its share of the research effort.

Since the negotiation, EPA has drafted a research plan to better identify research needs. EPA has
made a significant commitment to funding the research on health effects, risk assessment,
exposure,  and treatment research that will  be used in  conjunction with the Information Collection
Rule data to develop the Enhanced  Surface Water Treatment Rule and the Stage II DBP  rule.  This
topic is among EPA's top research priorities as described in the Strategic Plan for EPA's Office of
Research and Development.  EPA has reprogrammed research monies from other planned projects
and has requested additional money to conduct necessary research. By the end of FY 96 EPA will
have funded greater than $10 million of the estimated $50 million research effort.
For More Information  Contact the Safe Drinking Water Hotline at 1-800-426-4791
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