06-2931. 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: [e-mail].
• 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 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 [phone], and the telephone number for the Water Docket is [phone].

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: [phone]; e-mail address: [e-mail].

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 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 a,b)1	1999c, 2003 a,b.
2. EPA/AWWARF: Phase II (Lieberman et al. 1994, 1999)	2002, Fout et al, 2003.
	Dahling et al, 2002.
3. Missouri Ozark Plateau #1 (Davis and Witt, 1998, 1999) 2	2000.
4. Missouri Ozark Plateau #2 (Femmer, 1999) 3	2000.
5. Missouri Alluvial Aquifer (Vaughn, 1996) 4	N/A.
6. Wisconsin Migrant Worker Camp (USEPA et al., 1998a)	N/A
7. EPA Vulnerability (USEPA, 1998b)	N/A.
8. U.S.-Mexico Border (TX and NM) (Pillai, 1997)	N/A.
9. Whittier, CA (Yanko et al., 1999)	N/A.
10. Honolulu Board of Water Supply (Fujioka and Yoneyama, 1997)	2001.
11. New England (Doherty et al., 1998) 5	N/A.
12. California Study. (Yates, 1999)	N/A.
13-16. Three-State Study: (Battigelli, 1999)	(Maryland-Banks and 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 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: 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.