Document ID: EPA-HQ-OW-2002-0061-0004
Agency: epa
Document Type: Proposed Rule
Title: National Primary Drinking Water Regulations; Ground Water Rule; Notice of Data Availability
Posted Date: 2006-03-27T13:33:58Z

[Federal Register: March 27, 2006 (Volume 71, Number 58)]
[Proposed Rules]               
[Page 15105-15109]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr27mr06-33]                         

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

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 142

[EPA-HQ-OW-2002-0061; FRL-8046-5]

 
National Primary Drinking Water Regulations; Ground Water Rule; 
Notice of Data Availability

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proprosed rule; notice of data availability.

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

SUMMARY: On May 10, 2000, EPA published the proposed Ground Water Rule 
(GWR), a national primary drinking water regulation, in the Federal 
Register. The purpose of the proposed rule is to provide for increased 
protection against microbial pathogens in public water systems that use 
ground water sources. In the proposed rule, EPA presented 16 occurrence 
studies. Since the rule was proposed, new data have become available 
that further delineate pathogen and fecal indicator occurrence in 
groundwater. The purpose of this notice of data availability is to 
present additional occurrence studies that the Agency may use in 
performing its economic analysis of the final GWR, and to solicit 
comment on those additional studies and on whether EPA should consider 
any additional ground water microbial occurrence data not mentioned in 
the proposed rule or in this notice.

DATES: Comments must be received on or before April 26, 2006.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-HQ-OW-
2002-0061, by one of the following methods:
     http://www.regulations.gov: Follow the on-line 

instructions for submitting comments.
     E-mail: OW-Docket@epa.gov.
     Mail: Water Docket, Environmental Protection Agency, 
Mailcode: 4101T, 1200 Pennsylvania Ave., NW., Washington, DC 20460.
     Hand Delivery: Deliver your comments to Water Docket, EPA 
Docket Center, Environmental Protection Agency, Room B102, 1301 
Constitution Ave., NW., Washington, DC, Attention Docket ID No. OW-
2002-0061. Such deliveries are only accepted during the Docket's normal 
hours of operation, and special arrangements should be made for 
deliveries of boxed information.
    Instructions: Direct your comments to Docket ID No. EPA-HQ-OW-2002-
0061. EPA's policy is that all comments received will be included in 
the public docket without change and may be

[[Page 15106]]

made available online at http://www.regulations.gov, including any 

personal information provided, unless the comment includes information 
claimed to be Confidential Business Information (CBI) or other 
information whose disclosure is restricted by statute. Do not submit 
information that you consider to be CBI or otherwise protected through 
http://www.regulations.gov or e-mail. The http://www.regulations.gov 
Web site is an ``anonymous access'' system, which means EPA will not 
know your identity or contact information unless you provide it in the 
body of your comment. If you send an e-mail comment directly to EPA 
without going through http://www.regulations.gov your e-mail address 

will automatically be captured and included as part of the comment that 
is placed in the public docket and made available on the Internet. If 
you submit an electronic comment, EPA recommends that you include your 
name and other contact information in the body of your comment and with 
any disk or CD-ROM you submit. If EPA cannot read your comment due to 
technical difficulties and cannot contact you for clarification, EPA 
may not be able to consider your comment. Electronic files should avoid 
the use of special characters, any form of encryption, and be free of 
any defects or viruses. For additional information about EPA's public 
docket visit the EPA Docket Center homepage at http://www.epa.gov/epahome/dockets.htm.
 For additional instructions on submitting 

comments, go to Section I of the SUPPLEMENTARY INFORMATION section of 
this document.
    Docket: All documents in the docket are listed in the http://www.regulations.gov
 index. Although listed in the index, some 

information is not publicly available, e.g., CBI or other information 
whose disclosure is restricted by statute. Certain other material, such 
as copyrighted material, will be publicly available only in hard copy. 
Publicly available docket materials are available either electronically 
at http://www.regulations.gov or in hard copy at the Water Docket, EPA/

DC, EPA West, Room B102, 1301 Constitution Ave., NW., Washington, DC. 
The Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday 
through Friday, excluding legal holidays. The telephone number for the 
Public Reading Room is (202) 566-1744, and the telephone number for the 
Water Docket is (202) 566-2426.

FOR FURTHER INFORMATION CONTACT: Crystal Rodgers, Standards and Risk 
Management Division, Office of Ground Water and Drinking Water (MC 
4607M), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460; telephone number: (202) 564-5275; e-mail address: 
Rodgers.Crystal@epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does This Action Apply to Me?

    Today's action itself does not impose any requirements on anyone. 
Instead, it presents to interested parties pathogen and indicator 
occurrence data that the Agency has become aware of after publication 
of the proposed GWR. EPA is considering using this new information in 
this rulemaking.

B. What Should I Consider as I Prepare My Comments for EPA?

    1. Submitting CBI. Do not submit this information to EPA through 
http://www.regulations.gov or e-mail. Clearly mark the part or all of 

the information that you claim to be CBI. For CBI information in a disk 
or CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM 
as CBI and then identify electronically within the disk or CD-ROM the 
specific information that is claimed as CBI. In addition to one 
complete version of the comment that includes information claimed as 
CBI, a copy of the comment that does not contain the information 
claimed as CBI must be submitted for inclusion in the public docket. 
Information so marked will not be disclosed except in accordance with 
procedures set forth in 40 CFR part 2.
    2. Tips for Preparing Your Comments. When submitting comments, 
remember to:
     Follow directions--The agency may ask you to respond to 
specific questions or organize comments by referencing a Code of 
Federal Regulations (CFR) part or section number.
     Explain why you agree or disagree; suggest alternatives 
and substitute language for your requested changes.
     Describe any assumptions and provide any technical 
information and/or data that you used.
     Provide specific examples to illustrate your concerns, and 
suggest alternatives.
     Explain your views as clearly as possible, avoiding the 
use of profanity or personal threats.
     Make sure to submit your comments by the comment period 
deadline identified.

Abbreviations Used in This Notice

AWWARF American Water Works Association Research Foundation
AWWSCo American Water Works Service Company
BGMK Buffalo Green Monkey Kidney
CWS community water system
DV data verification
EPA Environmental Protection Agency
FR Federal Register
GWR Ground Water Rule
GWUDI Ground Water Under the Direct Influence of Surface Water
mL milliliters
MPN most probable number
NCWS non-community water system
NTNCWS non-transient non-community water system
PCR polymerase chain reaction
PWS public water system
RIA Regulatory Impact Analysis
RT-PCR reverse-transcriptase, polymerase chain reaction
SAL single agar layer
SDWIS Safe Drinking Water Information System
TCR Total Coliform Rule
TNCWS transient non-community water system
USGS United States Geological Survey

II. Purpose of This Document

    The purpose of this document is to present pathogen and indicator 
occurrence data that the Agency has become aware of since publication 
of the proposed GWR. EPA is considering the incorporation of the new 
information in the economic analysis of the final GWR.
    In the proposed GWR, EPA presented 16 occurrence studies. The 
Agency did not use data from all of those 16 studies in developing the 
proposed rule because certain studies had a different scope and were 
not nationally representative. Since the proposal, EPA has become aware 
of seven additional relevant studies. Based on public comments received 
on the proposed GWR, the Agency has re-evaluated the 16 occurrence 
studies described in the proposed rule and examined the data from the 
seven additional new studies. Some of these seven additional studies 
demonstrate actual pathogen and/or fecal indicator presence in ground 
water at detectable levels. The Agency believes that, when considered 
collectively, these studies inform EPA's understanding of the national 
occurrence of viruses and fecal indicators and confirm that certain 
public ground water systems may be at risk of fecal contamination, 
which may pose a threat to public health.

III. Background

A. New Occurrence Data and Information

    The proposed Ground Water Rule provided summaries of 16 studies 
that

[[Page 15107]]

evaluated pathogen and/or fecal indicator occurrence in U.S. ground 
waters (65 FR 30194). The preamble to the proposed rule discussed how 
EPA planned to use those studies in assessing public health risk (65 FR 
30207). Table III-1 lists these 16 studies and presents updated 
publication dates where available and applicable. Table III-1 also 
lists the seven additional studies that EPA is noticing for public 
comment today. This section also provides a summary of the additional 
studies.

       Table III-1.--List of Microbial Occurrence Studies/Surveys
------------------------------------------------------------------------
       Studies cited in Proposed Rule         Updated publication dates
------------------------------------------------------------------------
1. AWWARF/AWWSCo (Abbaszadegan, 1999         1999c, 2003 a,b.
 a,b)\1\.
2. EPA/AWWARF: Phase II (Lieberman et al.    2002, Fout et al, 2003.
 1994, 1999).
                                             Dahling et al, 2002.
3. Missouri Ozark Plateau 1 (Davis  2000.
 and Witt, 1998, 1999) \2\.
4. Missouri Ozark Plateau 2         2000.
 (Femmer, 1999) \3\.
5. Missouri Alluvial Aquifer (Vaughn, 1996)  N/A.
 \4\.
6. Wisconsin Migrant Worker Camp (USEPA et   N/A
 al., 1998a).
7. EPA Vulnerability (USEPA, 1998b)........  N/A.
8. U.S.-Mexico Border (TX and NM) (Pillai,   N/A.
 1997).
9. Whittier, CA (Yanko et al., 1999).......  N/A.
10. Honolulu Board of Water Supply (Fujioka  2001.
 and Yoneyama, 1997).
11. New England (Doherty et al., 1998) \5\.  N/A.
12. California Study. (Yates, 1999)........  N/A.
13-16. Three-State Study: (Battigelli,       (Maryland-Banks and
 1999).                                       Battigelli, 2002)\6\;
                                              (Maryland-Banks et al.,
                                              2001)\7\; (Minnesota DOH,
                                              2000).
------------------------------------------------------------------------
Additional Occurrence Studies:
    1. Pennsylvania Noncommunity Wells (Lindsey et al., 2002).
    2. Microbial Indicators (Karim et al., 2003, 2004).
    3. Southeast Michigan (Francy et al., 2004).
    4. Validation of Methods (USEPA, 2006).
    5. La Crosse, WI (Borchardt et al., 2004).
    6. Mountain Water Company in Missoula, MT (DeBorde et al., 1995).
    7. New Jersey (Atherholt et al, 2003).
------------------------------------------------------------------------
Updated results:
\1\ PCR: Rotavirus (62/448), Hepatitis A virus (31/448), Enterovirus (68/
  448).
\2\ Cell culture: Enterovirus (1/109).
\3\ Cell culture: Enterovirus (0/109).
\4\ Cell culture: Enterovirus (12/81).
\5\ Cell culture: Enterovirus (0/124); PCR: Enterovirus (11/119), HAV
  (37/119), Rotavirus (6/119).
\6\ Cell culture: Enteric virus (0/91); RT-PCR: Enteric virus (11/91).
\7\ Cell culture: Enteric virus (1/27); RT-PCR: Enteric virus (3/30).

1. Summary of Additional Occurrence Studies
    EPA is now aware of seven additional studies that provide 
information on pathogen occurrence in U.S. ground waters. These studies 
were designed to collect occurrence data for varying reasons. This 
section includes a summary of each study.
a. Pennsylvania Noncommunity Wells (Lindsey et al., 2002)
    The purpose of this study was to measure pathogen and indicator 
occurrence in a random stratified sample of non-community water system 
(NCWS) wells in primarily carbonate aquifers and crystalline aquifers, 
which are hydrogeologically sensitive settings. The United States 
Geological Survey (USGS) (Lindsey et al. 2002) analyzed 59 samples 
selected from 60 NCWS wells from September 2000 to January 2001 to 
assess the occurrence and distribution of pathogens in ground water 
used for non-community water supplies and indicator organisms 
(evaluated as surrogates for those pathogens).
b. Microbial Indicators (Karim et al., 2003, 2004)
    The overall objective of this study was to evaluate Methods 1601 
and 1602, analytical procedures that test for coliphage in water 
samples, and to develop a useful microbial indicator for assessing the 
vulnerability of groundwater for viral/fecal contamination (Karim et 
al., 2003, 2004). Researchers selected and sampled for one year 20 
ground water wells from 11 states from a previous national study 
(Abbaszadegan et al., 2003).
c. Southeast Michigan (Francy et al., 2004)
    The purpose of this study of small (serving fewer than 3,000 
people) public ground water supply wells was to assess the presence of 
both viral contamination and microbiological indicators of fecal 
contamination, relate the co-existence of indicators and enteric 
viruses, and consider the factors that affect the presence of enteric 
viruses. From July 1999 through July 2001, researchers collected a 
total of 169 regular samples and 32 replicate pairs in southeastern 
Michigan from 38 wells in discontinuous sand and gravel aquifers.
d. Validation of Methods (USEPA, 2006)
    The purpose of this two-phase study was to evaluate EPA Methods 
1601 and 1602 in detecting coliphages in ground water. In phase I, the 
data was used to further establish and quantify the performance of the 
methods. In phase II, the methods were applied to samples from 
geographically representative groundwater samples from both PWSs and 
private wells that were potentially vulnerable to fecal contamination.
e. La Crosse, WI (Borchardt et al., 2004)
    The objective of this study was to evaluate the vulnerability of 
six PWS wells in La Crosse, Wisconsin to enteric virus contamination 
(Borchardt et al. 2004). Researchers sampled monthly for

[[Page 15108]]

one year, analyzing for the presence of several viruses.
f. Mountain Water Company, MT (De Borde et al., 1995)
    Two PWS production wells located in the Missoula aquifer were 
tested for the presence of enteroviruses and coliphage every month for 
one year. Both wells were located in unsewered residential areas.
g. New Jersey (Atherholt et al., 2003)
    26 public water supply wells were sampled for a variety of fecal 
indicator organisms. Three wells were non-community water supplies. 69 
samples were collected from the 14 ground water wells (128 samples from 
all wells) between June 1999 and February 2002.

IV. Request for Comment

    Through this notice of data availability, EPA solicits public 
comment on the seven additional studies listed and summarized in this 
notice. In addition to soliciting public comment on those seven 
studies, EPA also solicits public comment on whether EPA should 
consider any ground water microbial occurrence data not included in the 
seven studies listed and summarized in this notice or in the proposed 
Ground Water Rule. EPA is not soliciting public comment on any other 
issues at this time.

V. References

Abbaszadegan, M., P.W. Stewart, M.W. LeChevallier, Rosen, Jeffery S. 
and C.P. Gerba. 1999a. Occurrence of viruses in ground water in the 
United States. American Water Works Association Research Foundation. 
Denver, CO, 162 p.
Abbaszadegan, M., P. Stewart, and M. LeChevallier. 1999b. ``A 
Strategy for Detection of Viruses in Groundwater by PCR.'' Applied 
and Envir. Microbiology, 65(2):444-449.
Abbaszadegan, M., M. Denhart, M. Spinner, G. Di Giovanni, and M. 
LeChevallier. 1999c. ``Identification of viruses present in ground 
water cell culture harvest by PCR.'' In Proceedings, Water Quality 
Technology Conference, Tampa, FL, October, 1999.
Abbaszadegan, M., M. LeChevallier and C. Gerba. 2003a. ``Occurrence 
of viruses in U.S. Groundwaters.'' Journal Amer. Water Works Assoc. 
95(9):107-120.
Abbaszadegan, M. 2003b. ``Viruses in Drinking Water and 
Groundwater'' in Encyclopedia of Environmental Microbiology, G. 
Bitton, editor in chief, John Wiley and Sons, New York, NY, p. 3288-
3300.
Atherholt, T., E. Feerst, B. Hovendon, J. Kwak, J. and D. Rosen. 
2003. ``Evaluation of indicators of fecal contamination in 
groundwater.'' Journal Amer. Water Works Assoc. 95(10):119-131.
Banks, W.S.L., C.A. Klohe, D.A. Battigelli. 2001. ``Occurrence and 
distribution of enteric viruses in shallow ground water and factors 
affecting well vulnerability to microbiological contamination in 
Worcester and Wicomico Counties, Maryland.'' USGS Water-Resources 
Investigations Report 01-4147.
Banks, W.S.L. and D.A. Battigelli. 2002. ``Occurrence and 
distribution of microbiological contamination and enteric viruses in 
shallow ground water in Baltimore and Harford Counties, Maryland.'' 
USGS Water-Resources Investigations Report 01-4216, 32 p.
Battigelli, D.A. 1999. ``Monitoring ground waters in Wisconsin, 
Minnesota, and Maryland for enteric viruses and candidate viral 
indicators.'' Unpublished report, February 23, 1999.
Borchardt, M.A., N. L. Haas, R.J. Hunt. 2004. ``Vulnerability of 
drinking-water wells in La Crosse, Wisconsin, to enteric-virus 
contamination from surface water contributions.'' Applied Envir. 
Microbiology 70(10):5937-5946.
Dahling, D.R. 2002. ``An improved filter elution and cell culture 
assay procedure for evaluating public groundwater systems for 
culturable enteroviruses.'' Water Envir. Research 74(6):564-568.
Davis, J.V. and E.C.Witt, III. 1999. ``Microbiological and Chemical 
Quality of Ground Water Used as a Source of Public Supply in 
Southern Missouri.'' USGS Water-Resources Investigations Report 99-
XXXX.
Davis, J.V. and E.C.Witt, III. 1998. ``Microbiological Quality of 
Public Water Supplies in the Ozark Plateaus Aquifer System, 
Missouri.'' USGS Fact Sheet 028-98.
Davis, J.V. and E.C.Witt, III. 2000. ``Microbiological and Chemical 
Quality of Ground Water Used as a Source of Public Supply in 
Southern Missouri--Phase I, May 1997-March 1998.'' USGS Water-
Resources Investigations Report 00-4038, 77 pp.
DeBorde, D.C., R. Ward. 1995. Results of one year of virus testing 
at two high-yield water table wells in areas served by septic 
systems. Unpublished report to Mountain Water Co., Missoula, MT.
Doherty, K. 1998. ``Status of the New England ground water viral 
study.'' Proceedings, American Water Works Association Annual 
Meeting, Dallas, Texas, June 23, 1998. American Water Works 
Association, Denver.
Femmer, S. 1999. ``Microbiological Quality of Older Wells in Public 
Water Supplies in the Ozark Plateaus Aquifer System, Missouri.'' 
Unpublished report to Missouri Department of Natural Resources.
Femmer, S. 2000. ``Microbiological and chemical quality of ground 
water used as a source of public supply in southern Missouri--Phase 
II, April-July, 1998.'' USGS Water-Resources Investigations Report 
00-4260.
Fout, S., B.C. Martinson, M.W.N. Moyer, and D.R. Dahling. 2003. A 
multiplex reverse transcription--PCR method for detection of human 
enteric viruses in groundwater. Appl. Envir. Microbiology 
69(6):3158-3164.
Francy, D.S., R.N. Bushon, J. Stopar, E.J. Luzano, and G.S. Fout. 
2004. ``Environmental factors and chemical and microbiological 
water-quality constituents related to the presence of enteric 
viruses in ground water from small public water supplies in 
Southeastern Michigan.'' USGS Scientific Investigations Report 2004-
5219, 54 p.
Fujioka, R.S. and B.S. Yoneyama. 1997. ``Vulnerability to pathogens: 
phase 1 water quality monitoring and assessment study.'' Unpublished 
report to the Honolulu Board of Water Supply by Hawaii Water 
Resources Center, University of Hawaii, WRRC 98-01, 54 p.
Fujioka, R.S. and B.S. Yoneyama. 2001. ``Assessing the vulnerability 
of groundwater sources to fecal contamination.'' Journal Amer. Water 
Works Assoc. 93(8):62-71.
Karim, M.R., M. Abbaszadegan, A. Alum, and M. LeChevallier. 2003. 
``Virological quality of groundwater'' in Proceedings, Water Quality 
Technology Conference, Philadelphia, PA, October, 1999.
Karim, M.R., M. LeChevallier, M. Abbaszadegan, A. Alum, J. Sobrinho, 
and J. Rosen. 2004. ``Microbial indicators for assessing the 
vulnerability of groundwater to fecal contamination.'' American 
Water Co. report, 106 p.
Lieberman, R.J., L.C. Shadix, B.S. Newport, S.R. Crout, S.E. 
Buescher, R.S. Safferman, R.E. Stetler, D. Lye, G.S. Fout, and D. 
Dahling. 1994. ``Source water microbial quality of some vulnerable 
public ground water supplies.'' Proceedings, Water Quality 
Technology Conference, San Francisco, CA, October, 1994.
Lieberman, R.J., L.C. Shadix, B.S. Newport, S.R. Crout, S.E. 
Buescher, R.S. Safferman, R.E. Stetler, D. Lye, G.S. Fout, and D. 
Dahling. 1999. ``Source water microbial quality of some vulnerable 
public ground water supplies.'' Unpublished report in preparation.
Lieberman, R.J., L.C. Shadix, B.S. Newport, C.P. Frebis, M.W.N. 
Moyer, R.S. Safferman, R.E. Stetler, D. Lye, G.S. Fout, and D. 
Dahling. 2002. ``Microbial monitoring of vulnerable public ground 
water supplies.'' American Water Works Association Research 
Foundation, Denver, CO, 162 p.
Lindsey, B.D., Raspberry, J.S. and Zimmerman, T.M. 2002. 
``Microbiological quality of water from noncommunity supply wells in 
carbonate and crystalline aquifers of Pennsylvania.'' U.S. 
Geological Survey Water--Resources Investigations Report 01-4268, 30 
p.
Minnesota Department of Health. 2000. ``Minnesota Department of 
Health viral occurrence study.'' Minnesota Department of Health, St. 
Paul, 7 p.
Pillai, S. 1997. ``Virus sampling and microbial analysis at the 
U.S.-Mexico border for the U.S. Environmental Protection Agency.'' 
Unpublished report for The Cadmus Group, Inc.
USEPA. 2006. National Field Study for Coliphage Detection in 
Groundwater:

[[Page 15109]]

Method 1601 and 1602 evaluation in regional aquifers. EPA Office of 
Water. EPA/822/R/06/002.
USEPA et al. 1998a. ``Wisconsin migrant worker camp drinking water 
quality study.'' Unpublished report prepared for U.S. EPA Region V, 
Safe Drinking Water Branch, July, 1998, 37 p.
USEPA. 1998b. ``GWR vulnerability assessment study, April 3, 1998.'' 
Unpublished report prepared by International Consultants, Inc. for 
the Office of Ground Water and Drinking Water, 29 p.
Vaughn, J.M. 1996. ``Sample Analyses.'' Attachment, unpublished 
letter on the analysis of alluvial wells in Missouri by J. Lane and 
K. Duzan, Missouri Department of Natural Resources, Rolla, MO, 
November 7, 1996.
Yanko, W.A., J.L. Jackson, F.P. Williams, A.S. Walker and M.S. 
Castillo. 1999. ``An unexpected temporal pattern of coliphage 
isolation in ground waters sampled from wells at varied distance 
from reclaimed water recharge sites.'' Wat. Research, 33:53-64.
Yates, M.V. 1999. Viruses and indicators in ground water, Results of 
repeated monitoring. Unpublished report, February 23, 1999.

    Dated: March 14, 2006.
Benjamin H. Grumbles,
Assistant Administrator, Office of Water.
[FR Doc. 06-2931 Filed 3-24-06; 8:45 am]

BILLING CODE 6560-50-P