Federal Register: July 14, 2010 (Volume 75, Number 134)
DOCID: fr14jy10-21 FR Doc 2010-15205
ENVIRONMENTAL PROTECTION AGENCY
U.S. Citizenship and Immigration Services
CFR Citation: 40 CFR Parts 141 and 142
RIN ID: RIN 2040-AD94
EPA ID: [EPA-HQ-OW-2008-0878; FRL-9166-8]
NOTICE: Part III
DOCID: fr14jy10-21
DOCUMENT ACTION: Proposed Rule.
SUBJECT CATEGORY:
National Primary Drinking Water Regulations: Revisions to the Total Coliform Rule
DATES: Comments must be received on or before September 13, 2010.
DOCUMENT SUMMARY:
The Environmental Protection Agency (EPA or the Agency) is proposing revisions to the 1989 Total Coliform Rule. The proposed Revised Total Coliform Rule offers a meaningful opportunity for greater public health protection beyond the current Total Coliform Rule. The proposed revisions require systems that have an indication of coliform contamination in the distribution system to assess the problem and take corrective action that may reduce cases of illnesses and deaths due to potential fecal contamination and waterborne pathogen exposure. This proposal also updates provisions in other rules that reference analytical methods and other requirements in the current TCR (e.g., Public Notification and Ground Water Rules). These proposed revisions are in accordance with the Safe Drinking Water Act as amended, which requires EPA to review and revise, as appropriate, each national primary drinking water regulation promulgated under the Safe Drinking Water Act not less often than every six years. As with the current Total Coliform Rule, the proposed Revised Total Coliform Rule applies to all public water systems.
SUMMARY:
Environmental Protection Agency
SUPPLEMENTAL INFORMATION
I. General Information
A. Regulated Categories and Entities
Entities potentially regulated by the proposed Revised Total
Coliform Rule (RTCR) are all public water systems (PWSs). Regulated categories and entities include the following:
Examples of regulated
Category entities
Industry.................................. Privatelyowned community
water systems (CWSs),
transient noncommunity
water systems (TNCWSs), and
nontransient noncommunity
water systems (NTNCWSs).
State, Tribal, and local governments...... Publiclyowned CWSs, TNCWSs, and NTNCWSs.
This table is not intended to be exhaustive, but rather provides a guide for readers regarding entities regulated by this action. This table lists the types of entities that EPA is now aware could potentially be regulated by this action. Other types of entities not listed in the table could also be regulated. To determine whether your facility is regulated by this action, you should carefully examine the definition of ``public water system'' in Sec. 141.2 and the section entitled ``Coverage'' in Sec. 141.3 in title 40 of the Code of Federal Regulations (CFR), and the applicability criteria in Sec. 141.850(b) of this proposed rule. If you have questions regarding the applicability of this action to a particular entity, consult the person listed in the preceding FOR FURTHER INFORMATION CONTACT section. [[Page 40927]]
B. Copies of This Document and Other Related Information
This document is available for download at http://www.epa.gov/
safewater/disinfection/tcr/. For other related information, see preceding discussion on docket.
Abbreviations Used in This Document
ADWR Airline Drinking Water Rule
AGI Acute Gastrointestinal Illness
AIDS Acquired Immune Deficiency Syndrome
AIP Agreement in Principle
AWWA American Water Works Association
ATP Alternative Test Procedure
AWOP Area Wide Optimization Program
BAT Best Available Technology
C Celsius
CA Corrective Action
CBI Confidential Business Information
CCR Consumer Confidence Report
CDC Centers for Disease Control and Prevention
CFR Code of Federal Regulations
COI Cost of Illness
CWS Community Water System
DBPs Disinfection Byproducts
DWC Drinking Water Committee
EA Economic Analysis
EC E. coli
ECMUG EC Medium with MUG
EPA United States Environmental Protection Agency
ETV Environmental Technology Verification
FR Federal Register
GW Ground Water
GWR Ground Water Rule
GWS Ground Water System
GWUDI Ground Water Under the Direct Influence of Surface Water HRRCA Health Risk Reduction and Cost Analysis
HUS Hemolytic Uremic Syndrome
ICR Information Collection Request
IESWTR Interim Enhanced Surface Water Treatment Rule
M Million
MCL Maximum Contaminant Level
MCLG Maximum Contaminant Level Goal
mg/L Milligrams per Liter
ml Milliliters
MOU Memorandum of Understanding
MRDL Maximum Residual Disinfectant Level
MUG 4methylumbelliferylBetaDglucuronide
NCWS Noncommunity Water System
NDWAC National Drinking Water Advisory Council
NPDWR National Primary Drinking Water Regulation
NTNCWS NonTransient NonCommunity Water System
NTU Nephelometric Turbidity Unit
OMB Office of Management and Budget
PN Public Notification
PWS Public Water System
RFA Regulatory Flexibility Act
RICP Research and Information Collection Partnership
RTCR Revised Total Coliform Rule
SAB Science Advisory Board
SBA Small Business Administration
SDWA Safe Drinking Water Act
SDWIS Safe Drinking Water Information System
SDWIS/FED Safe Drinking Water Information System Federal Version SOP Standard Operating Procedure
Stage 1 DBPR Stage 1 Disinfectants and Disinfection Byproducts Rule
Stage 2 DBPR Stage 2 Disinfectants and Disinfection Byproducts Rule SW Surface Water
SWTR Surface Water Treatment Rule
TC Total Coliforms
TCR Total Coliform Rule
TCRDSAC Total Coliform Rule/Distribution System Advisory Committee TNCWS Transient NonCommunity Water System
T&C Technology and Cost
US United States
UV Ultraviolet Radiation
WRF Water Research Foundation
Table of Contents
I. General Information
A. Regulated Categories and Entities
B. Copies of This Document and Other Related Information II. Background
A. Statutory Authority
B. Total Coliform Rule Distribution System Advisory Committee (TCRDSAC)
C. Other Outreach Processes
D. Public Health Concerns Addressed by the Proposed Revised Total Coliform Rule
1. Public health concerns, fecal contamination, and waterborne pathogens
2. Indicators
3. Occurrence of fecal contamination and waterborne pathogens III. Proposed Revised Total Coliform Rule
A. Proposed Rule Provisions and Rationale
1. Terms used in the proposed RTCR
2. MCLG and MCL for E. coli, and coliform treatment technique
3. Monitoring
4. Repeat samples
5. Treatment technique requirements
6. Violations
7. Providing notification and information to the public
8. Reporting and recordkeeping requirements for systems
9. Analytical methods
B. Proposed Compliance Date
C. Links to Other Drinking Water Rule Requirements
1. SWTR, Stage 1 and Stage 2 DBPRs, ADWR
2. GWR
3. Sanitary surveys
D. Best Available Technology (BAT)
1. Provisions
2. EPA's rationale
3. Request for comment
E. Variances and Exemptions
1. Provisions
2. EPA's rationale
3. Request for comment
F. Request for Comment on Other Issues Related to the Proposed RTCR
1. Consistency between the proposed RTCR and the GWR
2. Storage tank inspection and cleaning
3. States under EPA direct implementation
G. Limitations to the Public Comment on the Proposed RTCR IV. State Implementation
A. State Special Primacy Requirements
B. State Recordkeeping Requirements
C. State Reporting Requirements
D. Interim Primacy
E. Request for Comment
V. Distribution System Research and Information Collection Activities
A. Research and Information Collection Partnership
B. Distribution System Optimization Activities
C. Request for Comment
VI. Economic Analysis (Health Risk Reduction and Cost Analysis)
A. Regulatory Options Considered
B. Major Sources of Data and Information used in Supporting Analyses
1. Safe Drinking Water Information System Federal Version data
2. SixYear Review 2 data
3. Other information sources
C. Occurrence and Predictive Modeling
1. Model used for public water systems serving 4,100 or fewer people
2. Model used for public water systems serving more than 4,100 people
D. Baseline Profiles
E. Anticipated Benefits of the Proposed RTCR
1. Relative risk analysis
2. Changes in violation rates and corrective actions
3. Nonquantifiable benefits
F. Anticipated Costs of the Proposed RTCR
1. Total annualized present value costs
2. PWS costs
3. State costs
4. Nonquantifiable costs
G. Potential Impact of the Proposed RTCR on Households
H. Incremental Costs and Benefits
I. Benefits from Simultaneous Reduction of Cooccurring Contaminants
J. Change in Risk from Other Contaminants
K. Effects of Fecal Contamination and/or Waterborne Pathogens on the General Population and Sensitive Subpopulations
1. Risk to children, pregnant women, and the elderly
2. Risk to immunocompromised persons
L. Uncertainties in the Benefit and Cost Estimates for the Proposed RTCR
1. Inputs and their uncertainties
2. Sensitivity analysis
M. Benefit Cost Determination for the Proposed RTCR
N. Request for Comment on the Economic Analysis
VII. Statutory and Executive Order Review
A. Executive Order 12866: Regulatory Planning and Review
B. Paperwork Reduction Act
C. Regulatory Flexibility Act (RFA)
D. Unfunded Mandates Reform Act (UMRA)
E. Executive Order 13132: Federalism
F. Executive Order 13175: Consultation and Coordination with Indian Tribal Governments
G. Executive Order 13045: Protection of Children From Environmental Health Risks and Safety Risks
[[Page 40928]]
H. Executive Order 13211: Actions That Significantly Affect Energy Supply, Distribution, or Use
I. National Technology Transfer and Advancement Act
J. Executive Order 12898: Federal Actions to Address Environmental Justice in Minority Populations and LowIncome Populations
K. Consultations with the Science Advisory Board, National Drinking Water Advisory Council, and the Secretary of Health and Human Services
L. Impacts on Sensitive Subpopulations as Required by Section
1412(b)(3)(C)(i) of the 1996 Amendments of the Safe Drinking Water Act (SDWA)
M. Plain Language
VIII. References
II. Background
A. Statutory Authority
The Safe Drinking Water Act (SDWA) requires the EPA to review and
revise, as appropriate, each existing national primary drinking water
regulation (NPDWR) at least once every six years (SDWA section
1412(b)(9), 42 U.S.C. 300g1(b)(9)). In 2003, EPA completed its review
of the Total Coliform Rule (TCR) and 68 NPDWRs for chemicals that were
promulgated prior to 1997 (USEPA 2003, 68 FR 42908, July 18, 2003). The
purpose of the review was to identify new health risk assessments,
changes in technology, and other factors that would provide a health
related or technological basis to support a regulatory revision that
would maintain or improve public health protection. In the SixYear
Review 1 determination published in July 2003 (USEPA 2003, 68 FR 42908,
July 18, 2003), EPA stated its intent to revise the 1989 TCR (also referred to as the ``current TCR'').
B. Total Coliform Rule Distribution System Advisory Committee (TCRDSAC)
In June 2007, EPA established the Total Coliform Rule/Distribution System Advisory Committee (``TCRDSAC'' or ``the advisory committee'') in accordance with the provisions of the Federal Advisory Committee Act, 5 U.S.C. App.2, 9 (c), to provide recommendations to EPA on revisions to the 1989 TCR and on what information about distribution system issues is needed to better understand and address possible public health impacts from potential degradation of drinking water distribution systems (USEPA 2007a, 72 FR 35869, June 29, 2007). The decision to include a review of distribution system issues was made, in part, to address recommendations made by the Stage 2 Microbial and Disinfection Byproducts Federal Advisory Committee in December 2000 (USEPA 2000b, 65 FR 83015, December 29, 2000). The TCRDSAC used available information to analyze options for revisions to the TCR. The TCRDSAC also considered research and information needed to better understand and address public health risks from contamination of distribution systems.
The advisory committee consisted of representatives of EPA, State and local public health and regulatory agencies, consumer
organizations, environmental organizations, local elected officials,
Indian Tribes, and drinking water suppliers. A technical workgroup was
also formed to provide the advisory committee with necessary technical
support and analysis to facilitate the committee's discussions. The
advisory committee met on 13 occasions between July 2007 and September
2008. All advisory committee members agreed to and signed the final
Agreement in Principle (AIP) in September 2008. All of the
recommendations of the advisory committee are found in the signed AIP.
Pursuant to the AIP, EPA agreed to propose revisions to the TCR that,
to the maximum extent consistent with EPA's legal obligations, have the
same substance and effect as the elements of the AIP. Each party
represented on the advisory committee agreed in the AIP not to take any
action to inhibit the adoption and implementation of final rule(s) to
the extent it and the corresponding preamble have the same substance
and effect as the elements of the AIP. EPA also agreed in the AIP to
develop a Research and Information Collection Partnership (RICP) to
``inform and support the drinking water community in developing future
national risk management decisions pertaining to drinking water
distribution systems'' by providing ``a formal process for systematic
planning, implementation, analysis, and communication of distribution
system research and information collection'' (USEPA 2008c). A
discussion of the RICP can be found in section V of this preamble. The
AIP and details about the advisory committee can be found at EPA's Web
site at: http://www.epa.gov/safewater/disinfection/tcr/regulation_ revisions.html.
In addition to the outreach mentioned above, EPA agreed to engage in various future stakeholder meetings at least annually, to which all advisory committee members and the public at large would be invited. In April 2009, EPA held its first annual stakeholder meeting to provide draft proposed regulation updates and an opportunity for stakeholders to provide feedback on the development of the proposed RTCR. C. Other Outreach Processes
In addition to consulting with the advisory committee, EPA engaged
in several other activities as part of the Agency's outreach to
stakeholders in developing the proposed RTCR. EPA held a technical
workshop in Washington, DC, from January 30 to February 1, 2007, to
discuss available information on the current TCR and available
information regarding risks in distribution systems in support of
revisions to the TCR. Other EPA outreach activities, namely the
National Drinking Water Advisory Council consultation, Science Advisory
Board consultation, and the Tribal consultation, are discussed in section VII of this preamble.
D. Public Health Concerns Addressed by the Proposed Revised Total Coliform Rule
1. Public Health Concerns, Fecal Contamination, and Waterborne Pathogens
The proposed RTCR aims to increase public health protection through the reduction of potential pathways of entry for fecal contamination into the distribution system. Since these potential pathways represent vulnerabilities in the distribution system whereby fecal contamination and/or waterborne pathogens, including bacteria, viruses and parasitic protozoa could possibly enter the system, the reduction of these pathways in general should lead to reduced exposure and associated risk from these contaminants. Fecal contamination and waterborne pathogens can cause a variety of illnesses, including acute gastrointestinal illness (AGI) with diarrhea, abdominal discomfort, nausea, vomiting, and other symptoms. Most AGI cases are of short duration and result in mild illness. Other more severe illnesses caused by waterborne pathogens include hemolytic uremic syndrome (HUS) (kidney failure), hepatitis, and bloody diarrhea (WHO 2004). Chronic disease such as irritable bowel syndrome, reduced kidney function, hypertension and reactive arthritis can result from infection by a waterborne agent (Clark et al. 2008).
When humans are exposed to and infected by waterborne enteric
pathogens, the pathogens become capable of reproducing in the
gastrointestinal tract. As a result, healthy humans shed pathogens in
their feces for a period ranging from days to weeks. This shedding of
pathogens often occurs in the absence of any signs of clinical illness.
Regardless of whether a pathogen causes clinical illness in the [[Page 40929]]
person who sheds it in his or her feces, the pathogen being shed may
infect other people directly by persontoperson spread, contact with
contaminated surfaces, and other means which are referred to as
secondary spread. As a result, waterborne pathogens that are initially
waterborne may subsequently infect other people through a variety of
routes (WHO 2004). Sensitive subpopulations are at greater risk from
waterborne disease than the general population (Gerba et al. 1996). For
a discussion of sensitive subpopulations, see section VII.L of this preamble.
2. Indicators
Total coliforms are a group of closely related bacteria that, with a few exceptions, are not harmful to humans. Coliforms are abundant in the feces of warmblooded animals, but can also be found in aquatic environments, in soil, and on vegetation. Coliform bacteria may be transported to surface water by runoff or to ground water by infiltration. Total coliforms are common in ambient water and may be injured by environmental stresses such as lack of nutrients, and water treatments such as chlorine disinfection, in a manner similar to most bacterial pathogens and many viral enteric pathogens (including fecal pathogens). EPA considers total coliforms to be a useful indicator that a potential pathway exists through which fecal contamination can enter the distribution system. The absence (versus the presence) of total coliforms in the distribution system indicates a reduced likelihood that fecal contamination and/or waterborne pathogens are occurring in the distribution system.
Under the current TCR, each total coliformpositive sample is
assayed for either fecal coliforms or E. coli. Fecal coliform bacteria
are a subgroup of total coliforms that traditionally have been
associated with fecal contamination. Since the promulgation of the TCR,
more information and understanding of the suitability of fecal coliform
and E. coli as indicators have become available. Study has shown that
the fecal coliform assay is imprecise and too often captures bacteria
that do not originate in the human or mammal gut (Edberg et al. 2000).
On the other hand, E. coli is a more restricted group of coliform
bacteria that almost always originate in the human or animal gut
(Edberg et al. 2000). Thus, E. coli is a better indicator of fecal contamination than fecal coliforms.
3. Occurrence of Fecal Contamination and Waterborne Pathogens
a. Presence of fecal contamination. Fecal contamination is a very general term that includes all of the organisms found in feces, both pathogenic and nonpathogenic. Fecal contamination can occur in drinking water both through use of contaminated source water as well as direct intrusion of fecal contamination into the drinking water distribution system. Lieberman et al. (1994) discuss the general association between fecal contamination and waterborne pathogens. Biofilms in distribution systems may harbor waterborne bacterial pathogens and accumulate enteric viruses and parasitic protozoa (Skraber et al. 2005; Helmi et al. 2008). Waterborne pathogens in biofilms may have entered the distribution system as fecal contamination from humans or animals.
Cooccurrence of indicators and waterborne pathogens is difficult to measure. The analytical methods approved by EPA to assay for E. coli are able to detect indicators of fecal contamination. They do not specifically identify most of the pathogenic E. coli strains. There are at least 700 recognized E. coli strains (Kaper et al. 2004). About 10 percent of recognized E. coli strains are pathogenic to humans (Feng 1995; Hussein 2007; Kaper et al. 2004). Pathogenic E. coli include E. coli O157:H7, which is the primary cause of hemolytic uremic syndrome (HUS) in the United States (Rangel et al. 2005). The U.S. Centers for Disease Control and Prevention (CDC) estimates that there are 73,000 cases of illness each year in the U.S. due to E. coli O157:H7 (Mead et al. 1999). The CDC estimates that about 15 percent of all reported E. coli O157:H7 cases are due to water contamination (Rangel et al. 2005). Active surveillance by CDC shows that 6.3 percent of E. coli O157:H7 cases progress to HUS (Griffin and Tauxe 1991; Gould et al. 2009) and about 12 percent of HUS cases result in death within four years (Garg et al. 2003). About 4 to 15 percent of cases are transmitted within households by secondary transmission (Parry and Salmon 1998).
Because EPAapproved standard methods for E. coli do not typically identify the presence of the pathogenic E. coli strains, an E. coli positive monitoring result is an indicator of fecal contamination but is not necessarily a measure of waterborne pathogen occurrence. Specialized assays and methods are used to identify waterborne pathogens, including pathogenic E. coli.
One notable exception is the data reported by Cooley et al. (2007), which showed high concentrations of pathogenic E. coli strains in samples containing high concentrations of fecal indicator E. coli. These data are from streams and other poor quality surface waters surrounding California spinach fields associated with the 2006 E. coli O157:H7 foodborne outbreak. Data equivalent to these samples are not available from drinking water samples collected under the TCR.
Because E. coli is an indicator of fecal contamination (Edberg et al. 2000), and because of the general association between fecal contamination and waterborne pathogens (Lieberman et al. 1994; Lieberman et al. 2002), E. coli is a meaningful indicator for fecal contamination and the potential presence of associated pathogen occurrence.
b. Waterborne disease outbreaks. The CDC defines a waterborne disease outbreak as occurring when at least two persons (or one with amoebic meningoencephalitis) experience a similar illness after ingesting a specific drinking water (or after exposure to recreational water) contaminated with pathogens (or chemicals) (Kramer et al. 1996). The CDC maintains a database on waterborne disease outbreaks in the United States. The database is based upon responses to a voluntary and confidential survey form that is completed by State and local public health officials.
The National Research Council strongly suggests that the number of identified and reported outbreaks in the CDC database for surface and ground waters represents only a small percentage of actual number of waterborne disease outbreaks (NRC 1997; Bennett et al. 1987; Hopkins et. al. 1985 for Colorado data). Underreporting occurs because most waterborne outbreaks in community water systems are not recognized until a sizable proportion of the population is ill (Perz et al. 1998; Craun 1996), perhaps 1 percent to 2 percent of the population (Craun 1996).
EPA drinking water regulations are designed to protect against endemic waterborne disease and to minimize waterborne outbreaks. In contrast to epidemic, endemic refers to the persistent low to moderate level or the usual ongoing occurrence of illness in a given population or geographic area (Craun et al. 2006).
III. Proposed Revised Total Coliform Rule
The proposed RTCR maintains and strengthens the objectives of the current
[[Page 40930]]
TCR and is consistent with the recommendations in the AIP. The
objectives are: (1) To evaluate the effectiveness of treatment, (2) to
determine the integrity of the distribution system, and (3) to signal
the possible presence of fecal contamination. The proposed revision
better addresses these objectives by requiring systems that may be
vulnerable to fecal contamination (as indicated by their monitoring
results) to do an assessment, to identify whether any sanitary
defect(s) is (are) present, and to correct the defects. Therefore, the
Agency anticipates greater public health protection under the proposed
RTCR compared to the current TCR because of its more preventive
approach to identifying and fixing problems that affect or may affect public health.
The following is an overview of the key provisions of the proposed
FOR FURTHER INFORMATION CONTACT
Sean Conley, 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) 5641781; email address: conley.sean@epa.gov. For general information, contact the Safe Drinking Water Hotline, telephone number: (800) 4264791. The Safe Drinking Water Hotline is open Monday through Friday, excluding legal holidays, from 10 a.m. to 4 p.m. Eastern time.