Monday, January 14, 2002 - U.S. Government … · 2018-03-17 · Monday, January 14, 2002 Part II...

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Monday,

January 14, 2002

Part II

EnvironmentalProtection Agency40 CFR Parts 9, 141, and 142National Primary Drinking WaterRegulations: Long Term 1 EnhancedSurface Water Treatment Rule; Final Rule

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1812 Federal Register / Vol. 67, No. 9 / Monday, January 14, 2002 / Rules and Regulations

ENVIRONMENTAL PROTECTIONAGENCY

40 CFR Parts 9, 141, and 142

[WH–FRL–7124–2]

RIN 2040–AD18

National Primary Drinking WaterRegulations: Long Term 1 EnhancedSurface Water Treatment Rule

AGENCY: Environmental ProtectionAgency (EPA).ACTION: Final rule.

SUMMARY: In this document, EPA isfinalizing the Long Term 1 EnhancedSurface Water Treatment Rule(LT1ESWTR). The purposes of theLT1ESWTR are to improve control ofmicrobial pathogens, specifically theprotozoan Cryptosporidium, in drinkingwater and address risk trade-offs withdisinfection byproducts. The rule willrequire systems to meet strengthenedfiltration requirements as well as tocalculate levels of microbial inactivationto ensure that microbial protection isnot jeopardized if systems make changesto comply with disinfectionrequirements of the Stage 1 Disinfectionand Disinfection Byproducts Rule(DBPR). The LT1ESWTR applies topublic water systems that use surfacewater or ground water under the directinfluence of surface water and servefewer than 10,000 persons. TheLT1ESWTR builds upon the frameworkestablished for systems serving apopulation of 10,000 or more in theInterim Enhanced Surface WaterTreatment Rule (IESWTR). This rulewas proposed in combination with theFilter Backwash Recycling Rule (FBRR)in April 2000.DATES: This regulation is effectiveFebruary 13, 2002. As discussed in thesupplementary information section andconsistent with sections 1412(b)(10) and1445 of SDWA, regulated entities mustcomply with this rule starting March 15,2002. For judicial review purposes, thisfinal rule is promulgated as of 1 p.m.eastern time on January 14, 2002.ADDRESSES: Public comments, thecomment/response document,applicable Federal Register notices,other major supporting documents, anda copy of the index to the public docketfor this rulemaking (W–99–10, FinalLong Term 1 Enhanced Surface WaterTreatment Rule) are available for reviewat EPA’s Drinking Water Docket: 401 MStreet, SW., Rm. EB57, Washington, DC20460 from 9 a.m. to 4 p.m., EasternTime, Monday through Friday,excluding legal holidays. For access to

docket materials or to schedule anappointment please call (202) 260–3027.FOR FURTHER INFORMATION CONTACT: Fortechnical inquiries contact Tom Grubbsat 1200 Pennsylvania Avenue, NW.,MC4607, Washington, DC 20460, (202)564–5262. For general informationcontact the Safe Drinking Water Hotline,telephone (800) 426–4791. The SafeDrinking Water Hotline is open Mondaythrough Friday, excluding Federalholidays, from 9 a.m. to 5:30 p.m.Eastern Time.SUPPLEMENTARY INFORMATION:

Regulated Entities

Entities potentially regulated by theLT1ESWTR are public water systems(PWSs) that use surface water or groundwater under the direct influence ofsurface water (GWUDI) and serve fewerthan 10,000 persons. Regulatedcategories and entities include:

Category Examples of regu-lated entities

Industry ..................... PWSs that use sur-face water orGWUDI.

State, Local, Tribal orFederal Govern-ments.

PWSs that use sur-face water orGWUDI.

This table is not intended to beexhaustive, but rather provides a guidefor readers regarding entities likely to beregulated by the LT1ESWTR. This tablelists the types of entities that EPA isnow aware could potentially beregulated by this rule. Other types ofentities not listed in this table couldalso be regulated. To determine whetheryour facility is regulated by this action,you should carefully examine thedefinition of PWS in § 141.2 of title 40of the Code of Federal Regulations andapplicability criteria in § 141.501 oftoday’s final rule. If you have questionsregarding the applicability of theLT1ESWTR to a particular entity,consult the person listed in thepreceding FOR FURTHER INFORMATIONCONTACT section.

List of Abbreviations Used in ThisDocument:

AWWA American Water WorksAssociation

AWWSCo American Water WorksService Company

°C Degrees CelsiusCCP Composite Correction ProgramCCR Consumer Confidence ReportCDC Centers for Disease ControlCFR Code of Federal RegulationsCFSII Continuing Survey of Food

Intakes by IndividualsCOI Cost of Illness

CPE Comprehensive PerformanceEvaluation

CTA Comprehensive TechnicalAssistance

DAF Dissolved Air FlotationDBP Disinfection ByproductsDBPR Disinfectants and Disinfection

Byproduct RuleEPA Environmental Protection AgencyESWTR Enhanced Surface Water

Treatment RuleFACA Federal Advisory Committee

ActFBRR Filter Backwash Recycle RuleFR Federal Registergpm Gallons per MinuteGWUDI Ground Water Under Direct

Influence of Surface WaterHAA5 Haloacetic Acids

(Monochloroacetic, Dichloroacetic,Trichloroacetic, Monobromoaceticand Dibromoacetic Acids)

HRRCA Health Risk Reduction andCost Analysis

ICR Information Collection RequestIESWTR Interim Enhanced Surface

Water Treatment RuleLT1ESWTR Long Term 1 Enhanced

Surface Water Treatment RuleMCLG Maximum Contaminant Level

GoalM-DBP Microbial and Disinfectants/

Disinfection ByproductsNDWAC National Drinking Water

Advisory CouncilNPDWR National Primary Drinking

Water RegulationNODA Notice of Data AvailabilityNTTAA National Technology Transfer

and Advancement ActNTU Nephelometric Turbidity UnitsO&M Operation and MaintenanceOMB Office of Management and

BudgetPBMS Performance-based

Measurement SystemPRA Paperwork Reduction ActPWS Public Water SystemPWSS Public Water Supply

SupervisionRFA Regulatory Flexibility ActRIA Regulatory Impact AnalysisSAB Science Advisory BoardSBA Small Business AdministrationSBAR Small Business Advocacy

ReviewSBREFA Small Business Regulatory

Enforcement Fairness Act of 1996SDWA Safe Drinking Water ActSDWIS Safe Drinking Water

Information SystemSWTR Surface Water Treatment RuleTTHM Total TrihalomethanesUMRA Unfunded Mandates Reform

ActWTP Willingness to Pay

Table of Contents

I. Summary

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A. Why is EPA Promulgating theLT1ESWTR?

B. What is Cryptosporidium?C. What are the Health Concerns

Associated with Cryptosporidium?D. Does this Regulation Apply to My Water

System?E. How is the EPA Regulating

Cryptosporidium in the LT1ESWTR?F. What Other Requirements are Included

in this Rule?G. How Will this Regulation Protect Public

Health?II. Background

A. What is the Statutory Authority for theLT1ESWTR?

B. What is the Regulatory History for theLT1ESWTR?

C. How were Stakeholders Involved inDeveloping the LT1ESWTR?

D. What did the April 10, 2000 ProposalContain?

III. Discussion of the Final RuleA. What Level of Cryptosporidium

Removal does the LT1ESWTR Require?B. What Combined Filter Effluent

Requirements does the LT1ESWTRContain?

C. What Individual Filter MonitoringRequirements does the LT1ESWTRContain?

D. What Disinfection Profiling andBenchmarking Requirements does theLT1ESWTR Contain?

E. How does the Definition of GroundWater Under the Direct Influence ofSurface Water Change?

F. What Additional Requirements does theLT1ESWTR Contain for UnfilteredSystems?

G. What does the LT1ESWTR Require forFinished Water Reservoirs?

H. What is the Compliance Schedule forthe LT1ESWTR?

I. What Public Notification and ConsumerConfidence Report Requirements areContained in the LT1ESWTR?

IV. State ImplementationA. What Special State Primacy

Requirements does the LT1ESWTRContain?

B. What State Recordkeeping Requirementsdoes the LT1ESWTR Contain?

C. What State Reporting Requirements doesthe LT1ESWTR Contain?

D. How Must a State Obtain InterimPrimacy for the LT1ESWTR?

V. Economic Analysis (Health RiskReduction and Cost Analysis)

A. What are the Costs of the LT1ESWTR?B. What are the Household Costs of the

LT1ESWTR?C. What are the Benefits of the

LT1ESWTR?D. What are the Incremental Costs and

Benefits?E. Are there Benefits From the Reduction

of Co-Occurring Contaminants?F. Is there Increased Risk From Other

Contaminants?G. What are the Uncertainties in the Risk,

Benefit, and Cost Estimates for theLT1ESWTR?

H. What is the Benefit/Cost Determinationfor the LT1ESWTR?

VI. Other Requirements

A. Regulatory Flexibility Act (RFA), asamended by the Small BusinessRegulatory Enforcement Fairness Act of1996 (SBREFA), 5 U.S.C. 601 et seq.

B. Paperwork Reduction ActC. Unfunded Mandates Reform ActD. National Technology Transfer and

Advancement ActE. Executive Order 12866: Regulatory

Planning and ReviewF. Executive Order 12898: Environmental

JusticeG. Executive Order 13045: Protection of

Children from Environmental HealthRisks and Safety Risks

H. Consultations with the ScienceAdvisory Board, National DrinkingWater Advisory Council, and theSecretary of Health and Human Services

I. Executive Order 13132: Executive Orderson Federalism

J. Executive Order 13175: Consultation andCoordination With Indian TribalGovernments

K. Likely Effect of Compliance with theLT1ESWTR on the Technical, Financial,and Managerial Capacity of Public WaterSystems

L. Plain LanguageM. Congressional Review ActN. Executive Order 13211: Actions

Concerning Regulations ThatSignificantly Affect Energy Supply,Distribution, or Use

VII. References

I. Summary

A. Why Is EPA Promulgating theLT1ESWTR?

The Safe Drinking Water Act (SDWA)requires EPA to set enforceablestandards to protect public health fromcontaminants that may occur indrinking water. As explained in moredetail in the April 10, 2000 proposal fortoday’s rule (65 FR 19046), EPA hasdetermined that the presence ofmicrobiological contaminants is asubstantial health concern. If finishedwater supplies contain microbiologicalcontaminants, disease outbreaks mayresult. Disease symptoms may includediarrhea, cramps, nausea, jaundice,headaches, and fatigue. EPA has setenforceable drinking water treatmenttechniques to reduce the risk ofwaterborne disease outbreaks.Treatment technologies such asfiltration and disinfection can remove orinactivate microbiologicalcontaminants.

Physical removal is critical to thecontrol of Cryptosporidium because it ishighly resistant to standard disinfectionpractices. Cryptosporidiosis, theinfection caused by Cryptosporidium,may manifest itself as a severe infectionthat can last several weeks and maycause the death of individuals withcompromised immune systems. In 1993,Cryptosporidium caused over 400,000people in Milwaukee, WI to experience

intestinal illness. More than 4,000 werehospitalized and at least 50 deaths wereattributed to the cryptosporidiosisoutbreak. There have also beencryptosporidiosis outbreaks in Nevada,Oregon, and Georgia over the pastseveral years.

In 1990, the EPA Science AdvisoryBoard (SAB) cited drinking watercontamination as one of the mostimportant environmental risks andindicated that disease causing microbialcontaminants (i.e., bacteria, protozoa,and viruses) are probably the greatestremaining health risk managementchallenge for drinking water suppliers(USEPA/SAB, 1990). The LT1ESWTRaddresses this challenge by improvingthe control of a wide range of microbialpathogens in public drinking watersystems and, specifically addressingCryptosporidium for the first time insystems serving fewer than 10,000people.

B. What Is Cryptosporidium?Cryptosporidium is a protozoan

parasite found in humans, othermammals, birds, fish, and reptiles. It iscommon in the environment and widelyfound in surface water supplies (Rose,1998; LeChevallier and Norton, 1995;Atherholt et al., 1998; EPA, 2000a). Inthe infected animal, the parasitemultiplies in the gastrointestinal tract.The animal then excretes oocysts of theparasite in its feces. These oocysts aretiny spore-like organisms 4 to 6 micronsin diameter (too small to be seenwithout a microscope), which carrywithin them the infective sporozoites.The oocysts of Cryptosporidium are veryresistant to adverse factors in theenvironment and can survive dormantfor months in cool, dark conditions suchas moist soil, or for up to a year in cleanwater. When ingested by another animalthey can transmit the cryptosporidiosisdisease and start a new cycle ofinfection. Cryptosporidiosis is primarilya waterborne disease, but has also beentransmitted by consumption ofcontaminated food, unhygienic diaperchanging practices (and other person-to-person contact), and contact with youngfarm animals.

Cryptosporidium oocysts are noteasily killed by commonly-useddisinfectants. They are relativelyunaffected by chlorine and chloraminesin the concentrations that are used fordrinking water treatment. Oocystinfectivity appears to persist undernormal temperatures, although oocystsmay lose infectivity if sufficientlycooled or heated (USEPA, 2000a).Research indicates that oocysts mayremain viable even after freezing (Fayerand Nerad, 1996).

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C. What Are the Health ConcernsAssociated With Cryptosporidium?

When someone is infected withCryptosporidium, they may contractcryptosporidiosis, a disease which cancause diarrhea, stomach cramps, nausea,loss of appetite, and a mild fever.Cryptosporidium has becomerecognized as one of the most commoncauses of waterborne disease (drinkingand recreational) in humans in theUnited States. The parasite is found inevery region of the United States andthroughout the world (www.cdc.gov/ncidod/dpd/parasites/cryptosporidiosis/factsht_cryptosporidiosis.htm). Thesymptoms of cryptosporidiosis begin anaverage of seven days after infection.Persons with a normal, healthy immunesystem can expect their illness to last fortwo weeks or less, with constant orintermittent diarrhea. However, evenafter symptoms cease, an individual canstill pass Cryptosporidium in the stoolfor up to two months, and may be asource of infection for others.

Cryptosporidiosis is not treatable withantibiotics, so prevention of infection iscritical. People with weakened immunesystems (those with HIV/AIDS, oncancer chemotherapy, or who havereceived organ transplants) will havecryptosporidiosis for a longer period oftime, and it could become life-threatening. Young children, pregnantwomen, or the elderly infected withcryptosporidiosis can quickly becomeseverely dehydrated.

Twelve waterborne cryptosporidiosisoutbreaks have occurred at drinkingwater systems since 1984 (Craun, 1998;USEPA, 2000a). The largest of theknown outbreaks occurred inMilwaukee and was responsible for over400,000 illnesses and at least 50 deaths(Hoxie, et al., 1997; MacKenzie et al.,1994); other known outbreaks haveoccurred in smaller communities andhave involved many fewer people. Anincident such as a rainstorm that flushesmany oocysts into the source water orcauses a sanitary sewer overflowcombined with a water treatment plantupset could allow a large pulse ofoocysts to move past the multiplebarriers of a water treatment plant.

D. Does This Regulation Apply to MyWater System?

Today’s final regulation applies to allsmall (serving less than 10,000 people)public water systems (PWSs) that usesurface water or ground water under thedirect influence of surface water(GWUDI).

E. How Is the EPA RegulatingCryptosporidium in the LT1ESWTR?

In the IESWTR (63 FR 69478), EPAestablished a maximum contaminantlevel goal (MCLG) of zero forCryptosporidium. When establishing anMCLG, EPA must also establish either acorresponding Maximum ContaminantLevel (MCL) or a treatment technique. Inthe IESWTR and in today’s LT1ESWTR,the Agency chose to establish atreatment technique that relies onstrengthening water treatment processesalready in place. For filtered systemsthis means achieving at least 2-log (99percent) removal of Cryptosporidium bymeeting strengthened combined filtereffluent turbidity limits as establishedby today’s rule. For unfiltered systemsit means maintaining and improvingCryptosporidium control under existingwatershed control plans.

F. What Other Requirements AreIncluded in This Rule?

Today’s final regulation includesseveral requirements.—All surface water and GWUDI systems

serving fewer than 10,000 peoplemust meet the requirements forachieving a 2-log removal or controlof Cryptosporidium;

—Conventional and direct filtrationsystems must comply with specificcombined filter effluent turbidityrequirements while alternativefiltration systems (systems usingfiltration other than conventionalfiltration, direct filtration, slow sandfiltration, or diatomaceous earthfiltration), must demonstrate theability to achieve 2-log removal ofCryptosporidium and comply withspecific State-established combinedfilter effluent turbidity requirements;

—Conventional and direct filtrationsystems must continuously monitorthe turbidity of individual filters andperform follow-up activities if thismonitoring indicates a potentialproblem;

—Systems must develop a disinfectionprofile unless they can demonstratethat their TTHM and HAA5disinfection byproduct (DBP) levelsare less than 0.064 mg/L and 0.048mg/L respectively;

—Systems considering a significantchange to their disinfection practicemust develop a disinfectioninactivation benchmark of theirexisting level of microbial protectionand consult with the State forapproval prior to implementing thedisinfection change;

—Finished water reservoirs for whichconstruction begins after the effective

date of today’s rule must be covered;and

—Unfiltered systems must comply withupdated watershed controlrequirements that addCryptosporidium as a pathogen ofconcern.

G. How Will This Regulation ProtectPublic Health?

Today’s rule for the first timeestablishes Cryptosporidium controlrequirements for small systems byrequiring a minimum 2-log removal forCryptosporidium. The rule alsostrengthens filter performancerequirements to ensure 2-logCryptosporidium removal, establishesindividual filter monitoring to minimizecontaminant pass-through and supportimproved performance, includesCryptosporidium in the definition ofGWUDI, and explicitly considersunfiltered system watershed controlprovisions. Today’s rule also reflects acommitment to the importance ofmaintaining existing levels of microbialprotection in public water systems asplants take steps to comply with newlyapplicable DBP standards. Systemsconsidering significant changes to theirdisinfection practices must first evaluatecurrent levels of Giardia inactivation(and virus inactivation if applicable)and consult with their State PrimacyAgency for approval beforeimplementing those changes to assurethat current microbial protection is notsignificantly reduced. Thus, compliancewith the provisions of today’s rule willimprove public health protection byreducing the risk of exposure toCryptosporidium in small systemsserving fewer than 10,000 people evenas those systems begin to take steps tocomply with related DBP standards.

II. Background

A. What Is the Statutory Authority forthe LT1ESWTR?

The Safe Drinking Water Act (SDWAor the Act), as amended in 1986,requires EPA to publish a maximumcontaminant level goal (MCLG) for eachcontaminant which in the judgement ofthe EPA Administrator, may have anadverse effect on the health of persons,occurs in public water systems with afrequency and at a level of public healthconcern, and whose regulation wouldrepresent a meaningful public healthrisk reduction (Section 1412(b)(1)(A)).MCLGs are non-enforceable health goalsto be set at a level at which no knownor anticipated adverse effect on thehealth of persons occur and whichallows an adequate margin of safety(Section 1412(b)(4)). The Act was again

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amended in August 1996 (Public Law104–83), resulting in the renumberingand augmentation of certain sectionswith additional statutory language. Newsections were added establishing newdrinking water requirements.

The 1986 Amendments to SDWArequires EPA to publish an enforceableNational Primary Drinking WaterRegulation (NPDWR) that specifieseither a maximum contaminant level(MCL) or treatment technique (Sections1401(1) and 1412(7)(a)) at the same timeit publishes an MCLG. EPA isauthorized to promulgate a NPDWR thatrequires the use of a treatmenttechnique in lieu of establishing anMCL, if the Agency finds that it is noteconomically or technologically feasibleto ascertain the level of thecontaminant. Today’s rule relies uponthe treatment technique of improvedfilter performance based onstrengthened turbidity limits to controlfor Cryptosporidium because ananalytical method suitable for finishedwater compliance purposes is currentlynot economically or technologicallyfeasible. In accordance with a scheduleestablished by Section 1412(b)(2)(C) ofSDWA as added by the 1996Amendments to SDWA, EPA is requiredto promulgate today’s rule by November2000.

B. What Is the Regulatory History for theLT1ESWTR?

In 1989, EPA promulgated the SurfaceWater Treatment Rule (SWTR) (54 FR27486, June 29, 1989 (USEPA, 1989))that set MCLGs of zero for Giardialamblia, viruses, and Legionella andpromulgated regulatory requirements forall PWSs using surface water or GWUDI.The SWTR includes treatmenttechnique requirements for filtered andunfiltered systems that are intended toprotect against the adverse health effectsof exposure to Giardia lamblia, viruses,and Legionella, as well as many otherpathogenic organisms. Briefly, thoserequirements include (1) requirementsfor maintenance of a disinfectantresidual in the distribution system; (2)removal and/or inactivation of 3-log(99.9 percent) for Giardia and 4-log(99.99 percent) for viruses; (3) combinedfilter effluent turbidity performancestandard of 5 nephelometric turbidityunits (NTU) as a maximum and 0.5 NTUat the 95th percentile monthly, based on4-hour monitoring for treatment plantsusing conventional treatment or directfiltration (with separate standards forother filtration technologies); and (4)watershed protection and otherrequirements for unfiltered systems.Systems seeking to avoid filtration wererequired to meet avoidance criteria and

obtain avoidance determinations fromStates by December 30, 1991, otherwisefiltration must have been provided byJune 29,1993. For systems properlyavoiding filtration, later failures to meetavoidance criteria triggered arequirement that filtration be providedwithin 18 months.

The intention of the SWTR was toprovide appropriate multiple barriers oftreatment to control pathogenoccurrence in finished drinking water.Cryptosporidium, however, was notaddressed under the SWTR, becauseEPA lacked sufficient health,occurrence, and water treatment controldata regarding this organism at the timeof the rule’s development. The IESWTRand today’s final rule address these gapsin microbial protection.

In 1992, EPA initiated a negotiatedrulemaking (Reg-Neg) to develop adisinfectants and disinfectionbyproducts rule. The Reg-NegCommittee consisting of a variety ofstakeholder groups met from November1992 through June 1993. As part of thiseffort, the Committee concluded that theSWTR needed to be revised to addressthe health risk of high densities ofpathogens in poorer quality sourcewaters than the SWTR addressed as wellas the health risks of Cryptosporidium.The Committee recommended thedevelopment of three sets of rules: atwo-staged Disinfectants/DisinfectionByproducts Rule (DBPR), an ‘‘interim’’Enhanced Surface Water Treatment Rule(IESWTR), a ‘‘long term’’ EnhancedSurface Water Treatment Rule(LT1ESWTR), and an InformationCollection Rule. The IESWTR was onlyto apply to those systems serving 10,000or more persons. The Committee agreedthat the ‘‘long term’’ Enhanced SurfaceWater Treatment Rule would be neededfor systems serving fewer than 10,000persons.

Congress legislatively affirmed thisMicrobial/Disinfection Byproduct (M-DBP) strategy as part of the 1996 SDWAAmendments. As part of those newAmendments, Congress also establisheda new schedule for EPA promulgation ofthese rules (which is the basis for theNovember 2000 schedule for today’srule). EPA established the M-DBPAdvisory Committee under the FederalAdvisory Committee Act (FACA) in1997 to seek advice on how to proceedtowards these deadlines in light of newinformation available since the 1993negotiated rulemaking discussions. TheCommittee met five times in Marchthrough July 1997 to discuss issuesrelated to the IESWTR and the Stage 1DBPR. The Committee reachedagreement in July of 1997 and itsrecommendations are embodied in an

Agreement in Principle document datedJuly 15, 1997, which is also found intwo Notices of Data Availability (NODA)(USEPA1997a,b). The major issuesaddressed in the Agreement in Principlewere discussed in the NODA for theIESWTR (62 FR 59486, November 3,1997) and Stage 1 DBPR (62 FR 59388,November 3, 1997).

On December 16, 1998, EPApromulgated the IESWTR (63 FR 69478),which applies to surface water andGWUDI systems serving 10,000 or morepersons. The purposes of the IESWTRare to improve control of microbialpathogens (specificallyCryptosporidium) and to address risktrade-offs with DBPs. Key provisionsestablished in the IESWTR include: (1)An MCLG of zero for Cryptosporidium;(2) a 2-log Cryptosporidium removalrequirements for systems that filter; (3)strengthened combined filter effluentturbidity performance standards andindividual filter turbidity provisions; (4)disinfection benchmarking provisions toassure continued levels of microbialprotection while facilities take thenecessary steps to comply with newDBP standards; (5) inclusion ofCryptosporidium in the definition ofGWUDI, as another pathogen that wouldindicate the presence of GWUDI, and inthe watershed control requirements forunfiltered public water systems; (6)requirements for covers on new finishedwater reservoirs; and (7) sanitarysurveys for all surface water andGWUDI systems regardless of size.

Today’s rule is based in large partupon the data, research, and technicalanalysis that supported the majorcomponents included in the 1998IESWTR. To that degree, it reflects thenational interim microbial protectioncontrol strategy ratified by a wide rangeof experts and stakeholders as part ofthe 1997 M/DBP Agreement inPrinciple. However, as was discussed inthe April 10, 2000 proposal, today’s rulealso is based on new small systeminformation that became available since1998 and, equally important, it alsoreflects a major commitment tosignificantly reduce small systemcompliance burdens wherever possible,while maintaining public healthprotection.

C. How Were Stakeholders Involved inthe Development of the LT1ESWTR?

EPA began outreach efforts to developthe LT1ESWTR in the summer of 1998with two public meetings: one inDenver, Colorado and the other inDallas, Texas (USEPA, 1999a,b).Building on these two public meetings,EPA has also held a number ofadditional meetings with stakeholders,

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trade associations, environmentalgroups, and representatives of State andlocal elected officials. Of particularimportance for this rule, given its focuson small systems, EPA receivedvaluable input from small entityrepresentatives as part of the SmallBusiness Regulatory EnforcementFairness Act (SBREFA) panel. The panelwas initiated in April of 1998 andofficially convened in August of 1998.Many of the panel’s recommendationsare reflected in today’s rule.

EPA provided numerousopportunities for stakeholder and publicinvolvement. In early June 1999, EPAmailed an informal draft of theLT1ESWTR preamble to theapproximately 100 stakeholders whoattended either of the public stakeholdermeetings. Members of trade associationsand the SBREFA panel also received thedraft preamble. EPA received valuablesuggestions and stakeholder input from15 State representatives, tradeassociations, environmental interestgroups, and individual stakeholders.EPA proposed the LT1ESWTR on April10, 2000. During the comment period,the Agency held a public meeting inWashington D.C. on April 14, 2000.Additionally, the proposed rule waspresented to industry, Staterepresentatives, and the public in nearly50 meetings across the US, including aMay 30, 2000 meeting in Washington,D.C. with ten representatives of electedState and local officials (USEPA2000g,h). Finally, EPA mailedapproximately 200 copies of theproposed rule to stakeholders.

D. What Did the April 10, 2000 ProposalContain?

The proposed rulemaking package,which is the basis for today’s final rule,was entitled The Long Term 1 EnhancedSurface Water Treatment and FilterBackwash Proposed Rule (USEPA,2000b).

The proposed rule included twodistinct sets of provisions: LT1ESWTRprovisions and Filter BackwashRecycling Rule (FBRR) provisions. TheAgency promulgated the final FBRR ina Federal Register announcement onJune 8, 2001 (66 FR 31086), separatefrom today’s final rule. The LT1ESWTRproposed rule provisions applied tosurface and GWUDI systems servingfewer than 10,000 persons and includedthe following provisions:—2-log removal of Cryptosporidium;—Compliance with specific combined

filter effluent turbidity requirements;—Continuous turbidity monitoring for

individual filters with follow-upactivities if monitoring resultsindicated a potential problem;

—Development of a disinfection profileunless optional monitoring at aparticular plant demonstrated TTHMand HAA5 levels less than 0.064 mg/L and 0.048 mg/L respectively;

—Development of a Giardia inactivationdisinfection benchmark andconsultation with the State forapproval before making a significantchange in disinfection practices;

—Mandatory covers for all newlyconstructed finished water reservoirs;and

—Unfiltered system compliance withupdated watershed controlrequirements that addCryptosporidium as a pathogen ofconcern.

III. Discussion of the Final Rule

A. What Level of CryptosporidiumRemoval Does the LT1ESWTR Require?

1. What Does Today’s Rule Require?Today’s final rule establishes a

treatment technique requirement for 2-log removal of Cryptosporidium forsurface water and GWUDI systemsserving fewer than 10,000 persons. Thisrequirement applies between a pointwhere the raw water is not subject tocontamination by surface water runoffand a point downstream before or at thefirst customer.

2. How Was This RequirementDeveloped?

As discussed previously in today’srule, Cryptosporidium is amicrobiological contaminant that hascaused several outbreaks ofcryptosporidiosis and poses serioushealth risks. For these reasons, theAgency set forth to developrequirements to minimize risksassociated with Cryptosporidium indrinking water. In the IESWTR, EPAestablished a MCLG of zero forCryptosporidium. EPA decided toestablish 2-log removal ofCryptosporidium as the accompanyingtreatment technique for this MCLG. Thisrequirement is based on a number oftreatment effectiveness studies thatdemonstrate the ability of well-operatedconventional and direct filtration plantsto achieve at least a 2-log removal ofCryptosporidium (Patania et al., 1995;Nieminski and Ongerth, 1995; Ongerthand Pecoraro, 1995; LeChevallier andNorton, 1992; LeChevallier et al., 1991;Foundation for Water Research, 1994;Kelly et al., 1995; and West et al., 1994).The information and data in these eightstudies provide convincing evidencethat conventional and direct filtrationplants that employ coagulation,flocculation, sedimentation (inconventional filtration only), and

filtration steps, have the ability toachieve a minimum of 2-log removal ofCryptosporidium when meeting specificturbidity limits. EPA has also provideddata in the proposal for today’s finalrule that indicate the ability of slowsand filtration, diatomaceous earthfiltration, and alternative filtration(membrane filtration, cartridgefiltration, etc.) to achieve at least 2-logremoval of Cryptosporidium (Jacangeloet al., 1995; Drozd & Schartzbrod, 1997;Hirata & Hashimoto, 1998; Goodrich etal., 1995; Collins et al., 1996; Lykins etal., 1994; Adham et al., 1998; Shuler &Ghosh, 1991; Timms et al., 1995; Shuleret al., 1990; and Ongerth & Hutton,1997). The Agency believes that thetechnological feasibility for 2-logremoval is demonstrated for both largeand small systems and therefore today’srule extends the 2-log Cryptosporidiumremoval requirement established forlarge and medium systems in the 1998IESTWR to small systems serving fewerthan 10,000 persons.

3. What Major Comments WereReceived?

The majority of the commenters onthe proposed rule agreed with theappropriateness of establishing a 2-logremoval requirement forCryptosporidium. A few commentersnoted that small systems should not berequired to meet the sameCryptosporidium log removalrequirements as large systems. EPAdisagrees. The technological feasibilityof 2-log removal is well demonstrated(as shown in the studies discussed inthe proposal for today’s final rule) andthe Agency believes that persons servedby all sized systems should be affordedcomparable levels of public healthprotection (i.e., the small systemssubject to the LT1ESWTR should havethe same MCLG, and the 2-logCryptosporidium removal treatmenttechnique as large systems subject to theIESWTR).

B. What Combined Filter EffluentRequirements Does the LT1ESWTRContain?

1. What Does Today’s Rule Require?

Today’s final rule requiresstrengthened combined filter effluentperformance for conventional filtration,direct filtration, and alternativefiltration systems (systems usingfiltration technologies other thanconventional filtration, direct filtration,diatomaceous earth filtration, or slowsand filtration) as the treatmenttechnique for achieving a 2-log removalof Cryptosporidium. For conventionaland direct filtration systems, the

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turbidity level of representative samplesof a system’s combined filter effluentwater must be less than or equal to 0.3NTU in at least 95 percent of themeasurements taken each month. Theturbidity level of representative samplesof a system’s filtered water must at notime exceed 1 NTU. Under today’s rule,conventional and direct filtration plantsmeeting these filter performancerequirements are presumed to achieve atleast a 2-log removal ofCryptosporidium. Slow sand anddiatomaceous earth filtration plants arepresumed to achieve at least 2-logremoval of Cryptosporidium if theycontinue to meet the existing filterperformance requirements establishedin the SWTR. Systems using alternativefiltration (i.e., membrane filtration,cartridge filtration, etc.) mustdemonstrate to the State that theirsystem achieves 2-log removal ofCryptosporidium. The State will thenestablish appropriate turbidity limits toreflect this performance. At the end ofeach month, systems must report thetotal number of combined filter effluentturbidity measurements taken eachmonth, as well as the number andpercentage of turbidity measurementsthat exceeded their 95th percentileturbidity limit and the number ofmeasurements that exceeded theirmaximum turbidity limit. Combinedfilter effluent turbidity measurementsmust be kept for at least three years.

2. How Was This RequirementDeveloped?

In establishing the 2-log removal as atreatment technique forCryptosporidium, the Agency relied onthe aforementioned studies todemonstrate the technological feasibilityof establishing the 2-log removal. Thesestudies demonstrated that specifictreatment would achieve 2-log removalof Cryptosporidium when operated toachieve specific turbidity performancelimits. For conventional and directfiltration systems, studies demonstratedthat achieving a turbidity of 0.3 NTU 95percent of the time and never exceeding1 NTU would ensure at least 2-logremoval of Cryptosporidium. For slowsand and diatomaceous earth filtrationsystems, the studies demonstrated thatmeeting existing SWTR turbidity limitswould ensure at least 2-log removal ofCryptosporidium. Alternative filtrationsystems were shown to achieve at least2-log removal of Cryptosporidium at avariety of turbidities based on the typeof filtration and other site-specificcharacteristics. The requirements oftoday’s final rule reflect therecommendations of the 1997 M-DBPCommittee.

As part of the LT1ESWTRdevelopment process, EPA analyzedperformance data from 211 smallsystems in 15 different States. That dataindicated that a substantial number ofsmall systems are presently meeting thetighter performance standards of today’srule. For example, 50 percent of the 211systems are currently meeting 0.3 NTU12 months out of the year. In addition,93 percent of the 211 systems neverexceeded the 1 NTU maximum 12months out of the year. Therefore, EPAbelieves that the strengthened filterperformance standards established forsmall systems in today’s final rule arefeasible and achievable.

3. What Major Comments WereReceived?

The majority of the commenters onthe proposal agreed with theappropriateness of the combined filtereffluent requirements. Manycommenters raised concerns with theproposal’s reliance on turbidity as anindicator for demonstrating thatmembrane filtration meets the sameCryptosporidium removal requirementsas conventional and direct filtrationsystems. Commenters indicated thatalthough turbidity is the most prevalentform of water quality monitoring,establishing a 0.3 NTU 95th percentilelimit and 1 NTU maximum limit wouldnot be as appropriate an indicator of theperformance of membranes than otherparameters such as flux or membraneintegrity. They noted that usingturbidity was appropriate if site specificturbidity limits were utilized. At mostfacilities these limits would typically bemuch lower than 0.3 NTU.Additionally, commenters asserted thatsince the typical operational turbiditiesof membranes (< 0.05 NTU) were somuch lower than those of conventionalfiltration, it would be inappropriate torequire membranes to meet turbiditylimits that were significantly higherthan standard operating practices. Inresponse, EPA notes that in theproposed rule, EPA allowed membranesystems to meet either conventionalfiltration or alternative filtrationcombined filter effluent requirements.After further evaluating existing studiesand information provided bycommenters, EPA agrees that otherappropriate indicators may be used todetermine the treatment efficiency ofmembrane filtration, and that given thedifferent operational turbidities ofconventional filtration and membranefiltration, different turbidity limits areappropriate. Therefore, today’s final ruletreats membrane filtration as anavailable alternative filtrationtechnology, instead of requiring

membranes to meet the same turbiditylimits as conventional and directfiltration.

C. What Individual Filter MonitoringRequirements Does the LT1ESWTRContain?

1. What Does Today’s Rule Require?Today’s final rule establishes a

requirement that all systems usingsurface water or GWUDI, serving fewerthan 10,000 persons, and utilizingconventional or direct filtration mustcontinuously monitor the individualfilter turbidity for each filter used at thesystem. For purposes of this rule,continuous monitoring means at leastevery 15 minutes. Systems must keepthe results of this monitoring for at leastthree years. Each month systems mustreport to the State that they haveconducted individual filter turbiditymonitoring, and are required to indicatethe dates, filter number, and turbiditiesof any measurements that exceeded 1.0NTU. Today’s rule provides thatsystems with two or fewer filters maymonitor combined filter effluentturbidity continuously, in lieu ofindividual filter turbidity monitoring.Based on this monitoring, if a systemexceeds 1.0 NTU in two consecutivemeasurements the system must includethe filter number, date, time and reasonfor the exceedance at the end of themonth in its monthly filter performancereport to the State. If this occurs threemonths in a row for the same filter, asystem is required to conduct a self-assessment of the filter. If a self-assessment is required, it must takeplace within 14 days of the day the filterexceeded 1.0 NTU in two consecutivemeasurements for the third straightmonth. The system must report to theState that the self-assessment wascompleted. A self-assessment mustinclude at least the followingcomponents:—Assessment of filter performance;—Development of a filter profile;—Identification and prioritization of

factors limiting filter performance;—Assessment of the applicability of

corrections; and—Preparation of a self-assessment

report.If a system exceeds 2.0 NTU (in two

consecutive measurements 15 minutesapart) for two months in a row, thesystem must contact the State to arrangefor the State or an approved third partyto conduct a ComprehensivePerformance Evaluation (CPE) not laterthan 60 days following the day the filterexceeded 2.0 NTU in two consecutivemeasurements for the second straightmonth. The CPE must be completed and

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submitted to the State no later than 120days following the day the filterexceeded 2.0 NTU in two consecutivemeasurements for the second straightmonth.

2. How Was This RequirementDeveloped?

Performance of individual filterswithin a plant is of paramountimportance in preventing pathogenbreakthrough. Two important conceptsregarding individual filters underlietoday’s individual filter monitoringrequirement. First, as discussed in moredetail in the April 10, 2000 proposal,poor performance (and potentialpathogen breakthrough) of one filter canbe masked by optimal performance ofthe remaining filters, without exceedingcombined filter effluent turbidityperformance standards. Second, recentfilter performance researchdemonstrates that individual filters aresusceptible to turbidity spikes of shortduration that may not be captured byfour-hour combined filter effluentmeasurements. Several studies(Amirthatajah, 1988; Bucklin et al.,1988; Cleasby 1990; Hall and Croll 1996;and McTigue et al., 1998) haveconfirmed the frequency and magnitudeof individual filter turbidity spikes. Toaddress these spikes and the potentialfor masking, and provide systemoperators with information andadvanced warning with regards toindividual filter performance problemsbefore they lead to treatment techniqueviolations, the Agency proposedindividual filter turbidity monitoring.EPA proposed one option and requestedcomment on two alternative approaches.The alternatives consisted of anapproach identical to the IESWTR thatentailed significantly more burden, andan approach that included 95thpercentile and maximum triggersinstead of a trigger based on twoconsecutive measurements. Theproposed option has been revised inthree minor ways. In today’s rule:

—Systems with two or fewer filters maymonitor combined filter effluentturbidity continuously, in lieu ofindividual filter turbidity (theproposal required all filters bemonitored);

—Systems must schedule CPEs within60 days and complete them within120 days (the proposal required 30and 90 days);

—A system has 14 days following aturbidimeter malfunction to resumecontinuous individual filtermonitoring before a violation occurs(the proposal required 5 days).

3. What Major Comments WereReceived?

The majority of the commenters onthe proposal agreed with theappropriateness of the individual filtermonitoring requirements. The Agencyrequested comment on a variety ofissues to which commenters responded.Most commenters supported themodification that States be provided theopportunity to allow systems with twoor fewer filters to monitor combinedfilter effluent turbidity continuously, inlieu of individual filter turbidityindicating that poor performance of onefilter could not simply be masked byoptimal performance of an additionalfilter. The Agency has included thismodification in today’s final rulebecause it reduces the burden on smallsystems while still providingcontinuous monitoring that can be usedto indicate whether filters areperforming poorly.

Several commenters supported amodification to lengthen CPE schedulesby 30 days. The Agency has includedthis modification in today’s final rule inorder to provide States added flexibilityin performing these activities. The extra30 days will provide States theopportunity to marshal uniqueresources (specifically, employeestrained in conducting CPEs) andprioritize the conduct of CPEs, whenseveral systems trigger them during thesame time period.

Several commenters indicated thatallowing only five working days for anon-line turbidimeter to be off-line beforea violation resulted would beinappropriate for small systems.Commenters indicated that smallersystems often do not have back-up unitsonsite and would be required to contactmanufacturers and await shipping andinstallation which could easily exceedthe five days. EPA agrees and hasmodified the requirement to allowsystems serving fewer than 10,000persons, 14 days to resume onlinemonitoring prior to incurring aviolation.

Several commenters noted thatsystems serving fewer than 10,000persons should be subject to lessfrequent monitoring of individual filtereffluent. EPA believes that continuousindividual filter monitoring is feasibleand assures improved performance offiltration systems. As explained in theproposal, continuous filter monitoring isnecessary to identify short durationturbidity spikes which are likely to bemissed with less frequent monitoring.This is true for systems of all sizes. Lessfrequent monitoring would not identifymany turbidity spikes and accordingly

would not provide a comparable level ofpublic health protection as that ofcontinuous monitoring required forlarge systems under the IESWTR. Infact, the actual frequency of individualfilter monitoring has little effect onburden as much of the costs associatedwith monitoring are derived from thepurchase of the necessary equipmentand would be incurred regardless of thefrequency. Reduced monitoring wouldrepresent reduced public healthprotection and the Agency firmlybelieves that the consumers of thesesmall systems should be afforded acomparable level of public healthprotection as larger systems.

D. What Disinfection Profiling andBenchmarking Requirements Does theLT1ESWTR Contain?

1. What Does Today’s Rule Require?

Today’s final rule requires communityand non-transient non-communitysystems that use surface water orGWUDI and serve fewer than 10,000persons to develop a disinfection profilebased on a 52 week period. Systemsserving between 500 and 9,999 mustbegin profiling and notify the State tothis effect by July 1, 2003. Systemsserving fewer than 500 must beginprofiling and notify the State to thiseffect by January 1, 2004. To conductthe profile, systems must:—Monitor disinfectant residual

concentration, water temperature indegrees Celsius, pH, and contact timeduring peak hourly flow once a week(on the same calendar day) during allmonths that the system is operational;

—Calculate Giardia lamblia inactivationfor each of the 52 weeks; and

—Plot graphically, the 52 weeklyinactivations.Results of the profile must be kept

indefinitely. EPA is developingguidance materials that provide detailedinformation on this procedure. A Statemay determine that a system’s profile isunnecessary where a system submitsTTHM and HAA5 data that:—Is taken during the month of warmest

water temperature (beginning noearlier than 1998);

—Is taken at the point of maximumresidence time; and

—Reports levels of TTHM and HAA5 ofless than 0.064 mg/L and 0.048 mg/Lrespectively.Today’s final rule also requires any

system which developed a profile andwhich decides to make a significantchange to their disinfection practice todetermine their disinfection benchmark(the average microbial inactivationduring the month with the lowest

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inactivation), consult with the State forapproval, and provide the followinginformation during consultation:—Description of the proposed change;—Disinfection profile (and data used to

develop profile); and—Analysis of how the proposed change

will affect the current levels ofdisinfection.

Results of the disinfection benchmark(including the raw data and analysis)must be kept indefinitely.

2. How Was This RequirementDeveloped?

The disinfection benchmarkingrequirements provide the necessary linkbetween simultaneous compliance withmicrobial protection requirements of theIESWTR and LT1ESWTR anddisinfection byproduct requirements ofthe DBPR. The requirements wereestablished pursuant to the authority ofSection 1445 of SDWA to ensure thatsystems would not jeopardize microbialprotection when making changes indisinfection practices to comply withthe DBPR.

During the 1997 M/DBP FACAdeliberations, all participants agreed tothe fundamental premise that newstandards for control of DBPs must notlead to significant reductions in existinglevels of microbial protection. Thispremise is reflected in the 1997 M–DBPAdvisory Committee Agreement inPrinciple document. The AdvisoryCommittee reached agreement on theuse of a microbial profiling andbenchmarking process, whereby asystem and State, working together,could assure that there would not be asignificant increase in microbial risk asa result of modifying disinfectionpractices to meet MCLs for TTHM andHAA5. The final IESWTR establishedthe disinfection benchmark procedureto require large systems (serving 10,000or more persons) that might beconsidering a significant change to theirdisinfection practice (defined as systemswith TTHM or HAA5 concentrations ator above 80 percent of the respectiveMCLs (e.g., 0.064 mg/L TTHM or 0.048mg/L HAA5)) to evaluate the impact onmicrobial risk. Under the IESWTR, largesystems whose TTHM and/or HAA5average levels exceeded theaforementioned values were required todevelop a disinfection profile ofmicrobial inactivation over the course ofa year by calculating the daily level ofGiardia inactivation. Those largesystems required to develop adisinfection profile that also plan tomake a significant change todisinfection practices were required todevelop a ‘‘benchmark’’ of existing

levels of Giardia microbial protectionand to consult with the State prior toimplementing the change.

In developing the disinfectionbenchmarking requirements of theLT1ESWTR, EPA used the IESWTRrequirements as a starting point and,using significant input fromstakeholders, modified the requirementsto significantly reduce burden yetmaintain a comparable level of publichealth protection. The April 10, 2000proposal included several alternativesfor establishing the microbial profilingand benchmarking process.

Of the four TTHM and HAA5monitoring alternatives, the first wasidentical to the IESWTR, and includedfour quarters of monitoring at fourpoints in the distribution system. Thesecond alternative matched DBPcompliance monitoring, requiringsystems serving fewer than 500 tomonitor once per year, and systemsserving 500 or greater to monitorquarterly. A third alternative requiredonly one sample taken at the point ofmaximum residence time for allsystems. The fourth alternative (whichwas proposed) made TTHM and HAA5monitoring optional. This alternativewas chosen over the others, because itsignificantly reduces burden and theconcern about ‘‘early implementation,’’that is, the need for systems to complywith requirements of a rule beforeprimacy states have adopted newconforming regulations, while stillretaining the ability for systems andStates to utilize monitoring data todemonstrate low TTHM and HAA5levels, and therefore avoid profiling.Since this monitoring is no longerrequired to determine the applicabilityof systems to conduct profiles, the finalLT1ESWTR refers to this monitoring as‘‘optional monitoring.’’ The associatedTTHM and HAA5 samples that must beconducted under this optionalmonitoring, are described in section141.531. Of the four profilingalternatives, the first was identical tothe IESWTR, requiring daily profilingfor a year. The second alternative didnot require profiling. The thirdalternative, which was proposed,required weekly profiling for a year. Thefourth alternative required dailyprofiling during a single month. TheAgency proposed weekly profiling overthe course of a full year because itsignificantly reduces burden associatedwith conducting profiling (as comparedto the first alternative), but still providesinformation on the seasonal variationassociated with microbial inactivation,and develops an accurate microbialbenchmark as systems moved to complywith the Stage 1 DBPR. The second and

fourth profiling alternatives would notprovide such information. The Agencyhas revised the proposed option in oneminor way. In today’s rule:—Systems serving between 500 and

9,999 persons must begin weeklyprofiling no later than July 1, 2003,and systems serving fewer than 500persons must begin weekly profilingno later than January 1, 2004 (theproposal required all systems to beginprofiling no later than January 7,2003).

3. What Major Comments WereReceived?

The Agency received significantcomment on the disinfectionbenchmarking provisions of theproposed rule. Commenters bothsupported and opposed the proposed‘‘optional’’ TTHM and HAA5monitoring. Several commenters arguedthat EPA should not require systems orstates to undertake activities, evenoptional monitoring, before three yearsfrom the date a rule is promulgatedbecause it would result in earlyimplementation of the rule. While theAgency agrees that to the extentpossible, implementation should beminimized in the first three years afterthe promulgation of a national primarydrinking water regulation, as requiredby Section 1412(b)(10) of SDWA, theAgency continues to believe thatallowing systems to conduct optionalmonitoring prior to three years afterpromulgation is appropriate andauthorized under section 1445 ofSDWA.

Several commenters raised ‘‘earlyimplementation’’ concerns withprofiling as well, and suggestedprofiling should take place only afterusing the first round of DBP monitoringin 2004 as optional monitoring forprofiling activities. The Agency doesagree, that to the extent possible, earlyimplementation should be minimized inthe first two years after thepromulgation of the rule. However, theAgency believes that developing amicrobial profile and benchmark priorto compliance monitoring under theStage 1 DBPR is key to ensuring thatsystems do not jeopardize existingmicrobial protection when makingchanges to their disinfection practices tocomply with the Stage 1 DBPR.Consequently, today’s final rule requiressystems serving fewer than 500 personsto begin profiling in January 2004, whilesystems serving greater than 500 to9,999 persons are required to beginprofiling in July 2003.

Other commenters believed that theproposed requirement representedburden reduction for small systems and

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States while still achieving the goals ofoptional monitoring and profiling asdeveloped by the 1997 FACA and EPA.Additionally, commenters noted thatEPA should provide States and systemsthe ability to use more representativedata if available (i.e., allowing systemsto average over several quarters of datasimilar to the IESWTR requirements).EPA agrees that systems and Statesshould be allowed the opportunity touse more representative samples, andtoday’s final rule affords States theopportunity to allow morerepresentative data for optionalmonitoring and profiling.

E. How Does the Definition of GroundWater Under the Direct Influence ofSurface Water Change?

1. What Does Today’s Rule Require?

Today’s final rule modifies thedefinition of ground water under thedirect influence of surface water(GWUDI) to include Cryptosporidium,as another pathogen that would indicatethe presence of GWUDI, for all PWSs.

2. How Was This RequirementDeveloped?

Although ground water is typicallyprotected from microbial contaminantsthat are characteristic of surface watersupplies, some ground water systemsare susceptible to microbialcontamination from surface water.Ground water that exhibits physicalwater quality indicators that closelycorrelate with nearby surface water andwhich contain surface water indicatororganisms is ‘‘under the influence,’’ ofthat surface water. In order to protectcustomers of such systems fromillnesses resulting from exposure toGiardia and other microbial pathogens,the Agency addressed this issue duringdevelopment of the 1989 SWTR. Thefinal SWTR requires that systems withsource water found to be GWUDI aresubject to the filtration and disinfectionrequirements of Section 141 subpart H.

During development of today’s finalrule, the Agency proposed to modify thedefinition of GWUDI to includeCryptosporidium, as another pathogenthat would indicate the presence ofGWUDI. This is consistent with theapproach taken by the Agency in theIESWTR and is further supported byrecently available data indicatingCryptosporidium occurrence in 21public water system wells (Hancock etal., 1998). As a result, EPA believes itappropriate and necessary to includeCryptosporidium in the definition ofGWUDI for systems serving fewer than10,000 persons in today’s rule.

3. What Major Comments WereReceived?

Commenters agreed with theappropriateness of modifying thedefinition of GWUDI to includeCryptosporidium for all PWSs. Today’sfinal rule reflects the GWUDI definitionas proposed.

F. What Additional Requirements Doesthe LT1ESWTR Contain for UnfilteredSystems?

1. What Does Today’s Rule Require?

Today’s rule modifies therequirements for surface water orGWUDI systems serving fewer than10,000 persons that do not providefiltration by including Cryptosporidiumin the watershed control provisionseverywhere Giardia lamblia ismentioned.

2. How Was This RequirementDeveloped?

Watershed control requirements wereinitially established in 1989 as part ofthe SWTR. The SWTR contains specificconditions that a system must meet inorder to avoid filtration. Theseconditions include good source waterquality disinfection requirements,periodic on-site inspections, the absenceof waterborne disease outbreaks,compliance with the Total ColiformRule, and a watershed control program.The SWTR requires that the watershedcontrol program must be maintainedspecifically to minimize the potentialfor contamination by Giardia lambliacysts and viruses in the source water.

During development of today’s rule,the Agency proposed thatCryptosporidium should also beincluded as a focus in watershedprogram for unfiltered systems. For thesame public health reasons explained indetail as part of the April 10, 2000proposal and outlined earlier regardingthe risks associated with exposure toCryptosporidium, the Agency believes itis important that watershed controlrequirements for unfiltered systems berevised to include Cryptosporidium.This is particularly important sincesuch systems do not have the additionaltreatment barrier provided by filtrationto protect against possible pass-throughof Cryptosporidium into the distributionsystem.

3. What Major Comments WereReceived?

Commenters agreed with theappropriateness of includingCryptosporidium in the watershedcontrol program requirements forunfiltered systems. No substantive

changes were made to this provisionbetween proposal and today’s final rule.

G. What Does the LT1ESWTR Requirefor Finished Water Reservoirs

1. What Does Today’s Rule Require?

Today’s final rule requires that allfinished water reservoirs, holding tanks,or storage water facilities for finishedwater at systems serving fewer than10,000 persons, for which constructionbegins after March 15, 2002 must becovered.

2. How Was This RequirementDeveloped?

Open finished water reservoirs,holding tanks, and storage tanks areutilized by PWSs throughout thecountry. Because these reservoirs areopen to the environment and outsideinfluences, they can be subject to thereintroduction of contaminants that thetreatment plant was designed to remove.Existing EPA guidelines recommendthat all finished water reservoirs andstorage tanks be covered (USEPA, 1991).Additionally, many States currentlyrequire that finished water storage becovered, and the American Water WorksAssociation (AWWA) has issued apolicy statement strongly supporting thecovering of reservoirs that store potablewater (AWWA, 1983). In the July 29,1994 IESWTR proposal (59 FR 38832),the Agency requested comment onwhether to issue regulations requiringsystems to cover finished water storage.Most commenters supported eitherFederal or State requirements, withsome suggesting requirements shouldonly apply to newly constructedreservoirs. In the final IESWTR, theAgency required systems using surfacewater and GWUDI and serving 10,000persons or more to cover any newlyconstructed finished water reservoirs,holding tanks, or storage tanks. Throughdiscussions with stakeholders andevaluations of available information, theAgency is unaware of any newlyconstructed uncovered finished waterreservoirs at small systems sincediscussions with stakeholders regardingthe LT1ESWTR began in 1998. TheAgency is furthermore unaware of anyfuture plans of small systems toconstruct uncovered finished waterreservoirs. In fact the drinking waterindustry (regulators, consultants, andindustry groups) have discouraged theconstruction of new uncoveredreservoirs for many years. Furthermore,creating a prohibition on newlyconstructed uncovered finished waterreservoirs would not affect currentunfinished water reservoirs or even anysystem, which, despite the industry

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standard of constructing only coveredfinished water reservoirs, may havealready commenced construction on anuncovered finished water reservoirunbeknownst to the Agency orstakeholders which provided input onthe rule. Therefore, in accordance withSection 1412(b)(10) of SDWA, theAgency has determined it is practicableto require as part of today’s rule thatsystems serving fewer than 10,000people provide covers for all finishedwater reservoirs, holding tanks, or

storage reservoirs constructed afterMarch 15, 2002.

3. What Major Comments WereReceived?

Commenters agreed with theappropriateness of requiring that newlyconstructed finished water storage becovered. Several States noted that theycurrently require that all finished waterreservoirs be covered. No substantivechanges were made to this provisionbetween proposal and today’s final rule.

H. What Is the Compliance Schedule forthe LT1ESWTR?

1. When Must My System Comply WithEach of the Requirements of the Rule?

Each of the components of the finalLT1ESWTR has a specific compliancedate. The following table lists eachrequirement, along with the appropriateFederal Register citation and thecompliance date:

Rule requirements FR citation Compliance date

Cover new finished water reservoirs ...... § 141.511 ............................................... March 15, 2002.Comply with updated watershed control

requirements (unfiltered PWSs).§§ 141.520, 141.521 & 141.522 ............ January 14, 2005.

Begin Developing Disinfection Profile ..... §§ 141.530–141.536 .............................. July 1, 2003 for systems serving between 500 and 9,999persons and January 1, 2004 for systems serving fewerthan 500 persons.

Complete the Disinfection Profile ........... §§ 141.530–141.536 .............................. July 1, 2004 for systems serving between 500 and 9,999persons and January 1, 2005 for systems serving fewerthan 500 persons.

Combined Filter Effluent Turbidity Limits §§ 141.550, 141.551, 141.552, &141.553.

January 11, 2005.

Individual Filter Turbidity Monitoring ....... §§ 141.560, 141.561, 141.562, 141.563,141.564.

January 11, 2005.

2. What Major Comments WereReceived?

Many commenters noted that theywould not support requirements thatwould take place prior to two years afterthe promulgation of today’s final rule.Several others recommended requiringthat no portions of the rule should takeeffect until three years after the date ofpromulgation. The Agency does agreethat to the extent possible,implementation should be minimized inthe first two years after thepromulgation of the rule. However,today’s final rule requires systemsserving fewer than 500 persons to beginprofiling in January 2004, while systemsserving greater than 500 to 9,999persons are required to begin profilingin July 2003. This would allow time forStates to work with systems, yet stillprovide profiling data prior tocompliance sampling under the Stage 1DBPR.

I. What Public Notification andConsumer Confidence ReportRequirements Are Contained in theLT1ESWTR?

Today’s final rule modifies the PublicNotification (PN) requirements found inAppendix A and B of subpart Q of Part141 to include public notificationrequirements for systems subject to theLT1ESWTR that are consistent withthose for systems subject to theIESWTR.

Today’s rule does not specificallymodify the Consumer ConfidenceReport (CCR) Requirements found insubpart O of Part 141. However,consumer confidence reports mustcontain any violations of treatmenttechniques or requirements of NPDWRsas specified in § 141.153(d)(6) and§ 141.153(f). This includes any suchviolations of the LT1ESWTR.

Updated CCR and PN appendices canbe found on the Agency’s Web site athttp://www/epa.gov/safewater/tables.html.

IV. State Implementation

A. What Special State PrimacyRequirements does the LT1ESWTRContain?

In addition to adopting drinking waterregulations at least as stringent as theFederal regulations of the LT1ESWTR,EPA requires that States adopt certainadditional provisions related to thisregulation to have their programrevision application approved by EPA.This information advises the regulatedcommunity of State requirements andassists EPA in its oversight of Stateprograms.

Under the final LT1ESWTR, there areseveral special primacy requirementsthat a State’s application must include:

—Description of how the State willconsult with the system and approvemodifications to disinfectionpractices;

—Description of how the State willapprove a more representative data setfor optional monitoring and profilingunder §§ 141.530–141.536.

—Description of how existing rules,adoption of appropriate rules or otherauthority under § 142.16(i)(1) requiresystems to participate in aComprehensive Technical Assistance(CTA) activity, and the performanceimprovement phase of the CompositeCorrection Program (CCP);

—Description of how the State willapprove a method to calculate the logsof inactivation for viruses for a systemthat uses either chloramines, chlorinedioxide, or ozone for primarydisinfection; and

—For alternative filtration technologies(filtration other than conventionalfiltration treatment, direct filtration,slow sand filtration or diatomaceousearth filtration), a description of howthe State will determine under§ 142.16(i)(2)(iv), that a PWS may usea filtration technology if the PWSdemonstrates to the State, using pilotplant studies or other means, that thealternative filtration technology, incombination with the disinfectiontreatment that meets the requirementsof subpart T of this title, consistentlyachieves 3-log (99.9 percent) removaland/or inactivation of Giardia lambliacysts and 4-log (99.99 percent)removal and/or inactivation ofviruses, and 2-log (99 percent)removal of Cryptosporidium oocysts;and a description of how, for the

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system that makes this demonstration,the State will set turbidityperformance requirements that thesystem must meet 95 percent of thetime and that the system may notexceed at any time.

B. What State RecordkeepingRequirements Does the LT1ESWTRContain?

Today’s rule includes changes to theexisting recordkeeping provisions toimplement the requirements in today’sfinal rule. States must maintain recordsof the following:

(1) Records of turbiditymeasurements;

(2) Records of disinfectant residualmeasurements and other parametersnecessary to document disinfectioneffectiveness;

(3) Decisions made on a system-by-system basis and case-by-case basisunder provisions of section 141, subpartH or subpart P or subpart T;

(4) Records of systems consultingwith the State concerning a significantmodification to their disinfectionpractice (including the status of theconsultation);

(5) Records of decisions that a systemusing alternative filtration technologiescan consistently achieve a 2-log (99percent) removal of Cryptosporidiumoocysts, as well as the required levels ofremoval and/or inactivation of Giardiaand viruses for systems using alternativefiltration technologies, including State-set enforceable turbidity limits for eachsystem. A copy of the decision must bekept until the decision is reversed orrevised and the State must provide acopy of the decision to the system, and;

(6) Records of those systems requiredto perform filter self-assessments, CPEor CCP.

C. What State Reporting RequirementsDoes the LT1ESWTR Contain?

Currently States must reportinformation to EPA under section142.15 regarding violations, variancesand exemptions, enforcement actionsand general operations of State publicwater supply programs. There are noadditional requirements under this rule,but States are required to reportviolations, variances and exemptions,and enforcement actions related to thisrule.

D. How Must a State Obtain InterimPrimacy for the LT1ESWTR?

To maintain primacy for the PublicWater Supply Supervision (PWSS)program and to be eligible for interimprimacy enforcement authority forfuture regulations, States must adopttoday’s final rule. A State must submit

a request for approval of programrevisions that adopt the revised MCL ortreatment technique and implementregulations within two years ofpromulgation, unless EPA approves anextension per § 142.12(b). Interimprimacy enforcement authority allowsStates to implement and enforcedrinking water regulations once Stateregulations are effective and the Statehas submitted a complete and finalprimacy revision application. To obtaininterim primacy, a State must haveprimacy with respect to each existingNPDWR. Under interim primacyenforcement authority, States areeffectively considered to have primacyduring the period that EPA is reviewingtheir primacy revision application.

V. Economic Analysis (Health RiskReduction and Cost Analysis)

This section summarizes the HealthRisk Reduction and Cost Analysis(HRRCA) in support of the LT1ESWTRas required by section1412(b)(3)(C) ofthe 1996 SDWA. In addition, underExecutive Order 12866, RegulatoryPlanning and Review, EPA mustestimate the costs and benefits of theLT1ESWTR. EPA has prepared aneconomic analysis to comply with therequirements of this order and theSDWA Health Risk Reduction and CostAnalysis (USEPA, 2001a). The finaleconomic analysis has been publishedon the Agency’s Web site, and can befound at http://www.epa.gov/safewater/lt1eswtr. The analysis can also be foundin the docket for this rulemaking.

EPA has estimated the totalannualized cost for implementing theLT1ESWTR and analyzed the totalbenefits that result from the rule. Totalannual costs for the rule are $39.5million, in 1999 dollars, using threepercent discount rate [$44.8 millionusing a seven percent discount rate].The cost estimate includes capital costsfor treatment changes and start-up andannual labor costs for monitoring andreporting activities. More detailedinformation, including the basis forthese estimates and alternate costestimates using different cost of capitalassumptions are described in theLT1ESWTR economic analysis (USEPA,2001a). Combining the value of illnessand mortalities avoided, the estimate ofthe total quantified annual benefits ofthe LT1ESWTR range from $18.9million to $90.9 million. However, thisrange does not incorporate many of thesources of uncertainty related toquantifying benefits, including manybenefits the Agency was unable toevaluate. Accordingly, incorporatingadditional uncertainties wouldnecessarily increase the size of the

range. For example, the number ofavoided cases of cryptosporidiosismight be higher or lower than thenumber reflected in this range. Moredetailed information, including thebasis for these estimates, are describedin the LT1ESWTR economic analysis(USEPA, 2001a).

A. What Are the Costs of theLT1ESWTR?

In estimating the costs of today’s finalrule, the Agency considered impacts onPWSs and on States (includingterritories and EPA implementation innon-primacy States). The LT1ESWTRwill result in increased costs to publicwater systems for implementing thecomponents of today’s final rule. Stateswill also incur implementation costs.EPA estimates that the annualized costof today’s final rule will be $39.5million using a three percent discountrate ($44.8 million using a seven percentdiscount rate).

Approximately 84 percent ($33.1million using a 3 percent discount rateand $38.2 million using a 7 percentdiscount rate) of the rule’s total annualcosts are imposed on drinking waterutilities. States incur the remaining 16percent ($6.4 million using 3 percentand $6.6 million using 7 percent) of theLT1ESWTR’s total annual cost. Theturbidity provisions, which includetreatment changes, monitoring, andreporting, account for the largest portionof the total rule costs ($37.7 millionusing 3 percent and $42.7 million using7 percent). Systems will incur most ofthe turbidity provision costs and this isdiscussed in more detail in the nextsection. The national estimate of annualsystem costs is based on estimates ofsystem-level costs for the rule andestimates of the number of systemsexpected to incur each type of cost.Total capital costs for the LT1ESWTR(non-annualized) is $173.6 million.

Turbidity Provision Costs—Theturbidity provisions are estimated tocost both public drinking water systemsand States approximately $37.7 millionannually using a three percent discountrate ($42.7 million using 7 percent).However, the majority of these costswill be borne by the systems and are theresult of treatment changes to meet the0.3 NTU turbidity standard as well asthe cost for some systems to purchaseturbidimeters in order to meet themonitoring requirements of this rule.The Agency estimates that 2,207systems will modify their watertreatment in response to this ruleprovision while 2,327 conventional anddirect filtration systems will need toinstall turbidimeters. In addition to thecapital costs associated with this rule

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provision there will also be increases inoperation and maintenance (O&M)costs. These combined capital and O&Mcosts have an estimated cost to systemsof $27.1 million annually using a 3percent discount rate ($31.8 millionusing a 7 percent discount rate). TheO&M expenditures account for 59percent of the $27.1 million using a 3percent discount rate ($31.8 millionusing a 7 percent discount rate) whilethe remaining 41 percent representsannualized capital costs. In addition tothe turbidity treatment costs, turbiditymonitoring costs apply to all smallsurface water or GWUDI systems usingconventional or direct filtrationmethods. There are an estimated 5,817systems that fall under this criterion.The annualized individual filterturbidity monitoring cost to PWSs isapproximately $4.5 million using a 3percent discount rate ($4.7 millionusing 7 percent). In addition to theturbidity treatment and monitoringcosts, individual filter turbidityexceedance reporting is estimated tocost systems $0.6 million annually(using either a 3 percent or 7 percentdiscount rate).

The Agency estimated that the totalState cost for the turbidity provision(monitoring and exceptions) is $6.1million annually (using either a 3percent or 7 percent discount rate), withstart-up and monitoring comprising of81 percent of these annual costs ($4.9million annually using either a 3percent or 7 percent discount rate). Theremaining $1.2 million (using either a 3percent or 7 percent discount rate) inannual costs includes the costs forStates to review the individual filterturbidity exceedance reports andindividual filter self-assessment costs.

Disinfection Benchmarking Costs—The disinfection benchmarkingprovision involves three components:benchmarking, profiling, and optionalmonitoring. The start-up costs for thisprovision are estimated to cost systems$2.9 million ($0.2 million annualizedusing a three percent discount rate and$0.3 million using a seven percentdiscount rate). Disinfectionbenchmarking and profiling areestimated to cost systems approximately$0.4 million annually using a 3 percentdiscount rate ($0.5 million using 7percent). TTHM and HAA5 monitoringis optional and estimated to cost $0.3million annually using a 3 percentdiscount rate ($0.4 million using a 7percent discount rate). State disinfectionbenchmarking annualized costs areestimated to be $0.4 million using a 3percent discount rate ($0.5 millionusing a 7 percent discount rate). Thisestimate includes start-up, compliance

tracking/recordkeeping, andconsultation costs.

Covered Finished Water ReservoirProvision Costs—The LT1ESWTRrequires that small systems cover allnewly constructed finished waterreservoirs, holding tanks, or otherstorage facilities for finished water.Total annual costs, includingannualized capital costs and one year ofO&M costs are expected to be $0.8million (using either a 3 percent or 7percent discount rate) for this provision.This estimate is calculated from aprojected construction rate of newreservoirs and unit cost assumptions forcovering new finished water reservoirs.Also, the Agency believes that this is anoverestimate since there may beadditional States that currently requirefinished water requirement.

Although EPA has estimated the costof all the rule’s components on drinkingwater systems and States, there are somecosts that the Agency did not quantify.These non-quantifiable costs result fromuncertainties surrounding ruleassumptions and from modelingassumptions. For example, EPA did notestimate a cost for systems to acquireland if they needed to build a treatmentfacility or significantly expand theircurrent facility because the need for andcost of land is highly system specific.Additionally, if the cost for land wasprohibitive, an alternative complianceoption may be available (such asconnecting to another source). Onceagain, the Agency has not quantifiedcosts for this scenario due to the highdegree of site specificity. However,based on evaluations of ComprehensivePerformance Evaluations (CPEs), EPAbelieves that most systems possess morethan adequate property to construct newfacilities.

In addition, other LT1ESWTRprovisions may affect some systems butthe Agency was not able to quantifythese costs. These non-quantified costsinclude those for systems that incurincremental costs increases as a result ofincluding Cryptosporidium in thedefinition of GWUDI and also byincluding Cryptosporidium in thewatershed control requirements forunfiltered systems. The Agency lackeddata on the number of systemspotentially affected by these twoprovisions and was therefore, unable toestimate their costs. By includingCryptosporidium in the definition, moreground water systems may bedetermined to be under the directinfluence of surface water resulting inadditional cost because these systemsmust comply with the 1989 SurfaceWater Treatment Rule and today’s rule.EPA also did not estimate the costs for

unfiltered systems to controlCryptosporidium in their watersheds.These systems already control for otherpathogens from similar sources asCryptosporidium so it is likely that thisprovision will have a relatively minorimpact.

B. What Are the Household Costs of theLT1ESWTR?

The mean annual cost per householdis $6.24 and the cost per household isless than $15 for 90 percent of 6.3million households potentially affectedby today’s final rule. Of the remaininghouseholds, nine percent willexperience a range of annual costs from$15 to $120 ($10/month), while onlyone percent of households are estimatedto experience annual costs exceeding$120.

As indicated in the economic analysissupporting today’s final rule, per-household costs exceed $240/year forapproximately 5,600 households out ofthe 6.3 million households potentiallyimpacted by the LT1ESWTR. However,this analysis likely overestimates costsfor most of these households, allowingthat systems might choose to incur costswith up to 28 separate treatmentchanges when in fact it is likely to bemore cost-effective to install a newtreatment system. (This can be thoughtof as building an automobile piece bypiece from an auto parts store comparedto buying one at a dealership.) Theaforementioned 5,600 households areassociated with the end of the costdistribution where systems undertakean unrealistically large number oftreatment changes.

C. What Are the Benefits of theLT1ESWTR?

The primary benefits of today’s finalrule come from reductions in the risksof microbial illness from drinking water.In particular, LT1ESWTR focuses onreducing the risk associated withdisinfection resistant pathogens, such asCryptosporidium. Exposure to otherpathogenic protozoa, such as Giardia, orother waterborne bacteria, viralpathogens, and other emergingpathogens are likely to be reduced bythe provisions of this rule as well, butare not quantified. In addition,LT1ESWTR produces non-quantifiablebenefits associated with the riskreductions that result from theuncovered reservoir provision,including Cryptosporidium in GWUDIdefinition, and includingCryptosporidium in watershedrequirements for unfiltered systems.Non-quantifiable benefits also includereducing the risks to sensitivesubpopulations and the likelihood of

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incurring costs associated withoutbreaks.

1. Quantifiable Health BenefitsThe quantified benefits from this rule

are based solely on the reductions in therisk of cryptosporidiosis that result fromthe turbidity provision. As a result ofdata limitation, this analysis onlyaddresses endemic illness and notillness that results from epidemicdisease outbreaks. Cryptosporidiosis isan infection caused by Cryptosporidiumwhich is an acute, self-limiting illnesslasting 7 to 14 days, with symptoms thatinclude diarrhea, abdominal cramping,nausea, vomiting and fever (Juranek,1995). The monetized value of anavoided case of cryptosporidiosis isestimated to range from $796 to $1,411per case based on a cost-of-illnessmethodology (Harrington et al., 1985;USEPA 2001a). The high end of therange includes losses for medical costs,work time, productivity, and leisuretime. However, the low end of the rangeonly values medical costs and worktime. The medical costs may beoverestimated as they are assumed to bethe same as medical costs for a case ofGiardiasis which has a significantlylonger duration. However, the Agencybelieves it is appropriate not to proratemedical costs for the shorter duration ofCryptosporidiosis because (1) availabledata suggests that the median length ofhospital stays is essentially the same forCryptosporidiosis compared toGiardiasis; (2) the Harrington et al.study was conducted in the mid-1980’s,and consequently, the higher directmedical costs associated with treatingindividuals with HIV/AIDS, who aremore severely impacted byCryptosporidiosis, was not included;and (3) Cryptosporidiosis has no knownmedical treatment and available dataindicates that the range of the length ofhospital stays for immunocompromisedindividuals is larger for cases ofCryptosporidiosis compared toGiardiasis. The Agency also recognizeshowever, that many individuals withCryptosporidiosis do not seek medicaltreatment and thus have little or noassociated medical cost, and that thepercentage of such cases may be higherfor Cryptosporidiosis than Giardiasisgiven its shorter duration.

The benefits of the turbidityprovisions of LT1ESWTR come fromimprovements in filtration performanceat water systems. The benefits analysisaccounts for some of the variability anduncertainty in the analysis by estimatingbenefits under two different currenttreatment and three improved removalassumptions. In addition, EPA usedMonte Carlo simulations to derive a

distribution of estimates to addressuncertainty.

In order to quantify the benefits ofthis rule, the Agency estimated changesin the incidence of cryptosporidiosisthat would result from the rule. Theanalysis included estimating thebaseline (pre-LT1ESWTR) level ofexposure and risk fromCryptosporidium in drinking water andthe reductions in such exposure andrisk resulting from the turbidityprovisions of the LT1ESWTR. Baselinelevels of Cryptosporidium in finishedwater were estimated by assumingnational source water occurrencedistribution (based on data byLeChevallier and Norton, 1995) and anational distribution ofCryptosporidium removal by treatment.

In the LT1ESWTR economic analysis,the following two assumptions weremade regarding the currentCryptosporidium oocyst removalperformance to estimate finished waterCryptosporidium concentrations. First,based on treatment removal efficiencydata presented in the proposal, EPAassumed a national distribution ofphysical removal efficiencies with amean of 2.0 logs and a standarddeviation of 0.63 logs. Because thefinished water concentrations of oocystsrepresent the baseline against whichimproved removal from the LT1ESWTRis compared, variations in the logremoval assumption could haveconsiderable impact on the riskassessment. Second, to evaluate theimpact of the removal assumptions onthe baseline and resultingimprovements, an alternative mean logremoval/inactivation assumption of 2.5logs and a standard deviation of 0.63logs were also used to calculate finishedwater concentrations ofCryptosporidium.

For each of the two baselineassumptions, EPA assumed that acertain number of plants would showlow, mid, or high improved removal asa result of the turbidity provisions. Theamount of improved removal dependsupon factors such as water matrixconditions, filtered water turbidityeffluent levels, and coagulant treatmentconditions. The low, mid, and highimproved removals were derived fromPatania et al., (1995). This studydemonstrated that an incrementaldecrease in turbidity from 0.3 NTU to0.1 NTU (or a 0.2 NTU reductionoverall) resulted in increased oocystremovals of up to one-log. The Agencyused this data to construct low, mid,and high removal assumptions thatwould capture uncertainty associatedwith improved removal. The Agencyalso utilized different low, mid, and

high removal assumptions for distinctcategories of current turbidityperformance (<.2NTU, 0.2–0.3 NTU,0.3–0.4 NTU, and > 0.4 NTU). Forinstance, systems currently operating atgreater than 0.4 NTU would need totarget 0.2 NTU to ensure compliancewith the 0.3 NTU limit and EPAaccordingly assumed a low improvedremoval of 0.5-log, a mid improvedremoval of 0.75-log and a high improvedremoval of 0.9-log. However, systemscurrently operating between 0.2 NTUand 0.3 NTU were only expected tominimally improve turbidityperformance and would therefore onlyexpect improved log removals of 0.15,0.25, and 0.3 (low, mid, and high). Asa result, the economic analysisconsiders various baseline and with-rulescenarios to develop a range of endemichealth damages avoided. Additionalinformation is found in the Benefitschapter of the Economic Analysissupporting today’s final rule.

The finished water Cryptosporidiumdistributions that would result fromadditional log removal with theturbidity provisions were derivedassuming that additional log removalwas dependent on current removal, i.e.,that systems currently operating at thehighest filtered water turbidity levelswould show the largest improvementsor high improved removal assumption.For example, plants now failing to meeta 0.4 NTU limit would show greaterremoval improvements than plants nowmeeting a 0.3 NTU limit.

In addition to assuming the moreconservative baseline and removalassumptions, the lower-end of theLT1ESWTR’s benefit estimate does notinclude valuations for leisure time,productivity losses (returning to workbut still experiencing symptoms), andother loss categories that the authorsdiscuss but do not quantify (e.g., ‘‘highvalued’’ leisure). The authors(Harrington et al.) were highly confidentin the estimates for direct medicalexpenditures and work losses whichcomprise the lower benefit estimate; andless confident in the values for leisuretime losses and productivity losseswhich are included in the upper benefitestimate only. The decreased level ofconfidence was based on the data andmethods used to estimate only theselosses. The authors also conclude that:‘‘* * * nonetheless, the loss categoriesin this group–[productivity, leisuretime, etc.] are unquestionably presentand therefore, raise losses above thosereported in [the lower-end benefitestimate]’’. The Agency believes thatthese categories have positive value asstated in Harrington et al. consequentlythe lower-end estimate for the

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LT1ESWTR understates the true valueof these loss categories.

The Agency further notes that themedical expense component of thevaluation may be overstated because itis not prorated for the shorter durationof Cryptosporidiosis relative toGiardiasis (mean duration of 11.5 v. 41.6days). The Agency believes this isappropriate however, because (1)available data suggests that the medianlength of hospital stays is essentially thesame for Cryptosporidiosis compared toGiardiasis; (2) the Harrington et al.study was conducted in the mid-1980’s,and consequently, the higher directmedical costs associated with treatingindividuals with HIV/AIDS, who aremore severely impacted byCryptosporidiosis, was not included;and (3) Cryptosporidiosis has no knownmedical treatment and available dataindicates that the range of the length ofhospital stays for immunocompromisedindividuals is larger for cases ofCryptosporidiosis compared toGiardiasis. The Agency also recognizeshowever, that many individuals withCryptosporidiosis do not seek medicaltreatment and thus have little or noassociated medical cost, and that thepercentage of such cases may be higherfor Cryptosporidiosis than Giardiasisgiven its shorter duration.

Table V.1 indicates estimated annualquantified benefits associated withimplementing the LT1ESWTR. Thebenefits analysis examines only theendemic health damages avoided basedon the LT1ESWTR for each of theturbidity provision scenarios discussedpreviously. For each of these scenarios,EPA calculated the mean of thedistribution of the number of illnessesavoided. The 10th and 90th percentilesimply that there is a 10 percent chancethat the estimated value could be lower

than the 10th percentile and there is a10 percent chance that the estimatedvalue could be higher than the 90thpercentile. The modeling assumptionsused to obtain the distribution of illnessand mortality avoided for each baselineand the removal scenarios considersboth variability and uncertainty.Specifically, the Agency used a 2-dimensional Monte Carlo simulation toinclude both uncertainty and variabilityinputs. The components that EPAconsidered uncertain include theprobability of illness given an infection,the variability of Cryptosporidium tocause either an infection or illness, andthe infectivity dose-response factor. Thevariability components include:Cryptosporidium occurrence in thefinished water, individual dailydrinking water consumption, and thenumber of days per year of exposure.

In the 2-dimensional simulationstructure, a set of values for theuncertainty parameters is chosen fromtheir respective distributions. This set ofvalues is then ‘‘frozen’’ and a specifiednumber of iterations are run wheredifferent values are chosen for thevariability factors. This process isrepeated for some specified number ofsets of uncertainty parameters. For thisanalysis, 250 sets of uncertaintyparameters were used, with 1,000variability iterations performed on eachof the 250 uncertainty sets.

This modeling exercise provides theAgency with 250 sets of statistics forindividual annual risk of illness (e.g.,mean, standard deviation) that eachreflect different possible combinationsof uncertainty factors. The 250 estimatesfor each set of statistics (i.e., mean,confidence intervals) were then used tocompute an overall population averageannual risk of illness.

Next, the Agency estimates cases ofillness and mortality from the average

annual risk of illness estimates. In orderto do this, the average annualprobability of illness is multiplied bythe number of exposed individuals. In aseparate Monte Carlo simulation for thiscalculation, the average annualprobability of illness is treated as anuncertainty variable. As a result, theAgency has mean estimates withconfidence intervals for various baselineand post LT1ESWTR assumptionsregarding Cryptosporidium removalfrom source water. The 90th percentileconfidence bounds on the expectedvalues largely reflect the followinguncertainty variables: the probability ofillness given infection, the variability ofCryptosporidium to cause either aninfection or illness, and the infectivitydose-response factor.

The Agency has done its best torepresent a reasonable range ofquantifiable uncertainty using standardmodeling techniques. However, theAgency recognizes that additionalsources of uncertainty exist which couldnot be quantified. To the extent thatthese are significant, the true range ofuncertainty may be greater than thatreflected in the quantified analysis.

EPA has evaluated drinking waterconsumption data from USDA’s 1994–1996 Continuing Survey of Food Intakesby Individuals (CSFII) Study. EPA’sanalysis of the CSFII Study using the‘‘all sources, consumer only’’information resulted in a daily wateringestion lognormally distributed with amean of 1.2 liters per person per day(USEPA, 2000j). Results of alternativemodel calculations based on USDAconsumption data for ‘‘communitywater supplies, all respondents’’ (meanof 0.93 liters per person per day) arepresented in the appendix to theeconomic analysis as a lower boundestimate.

TABLE V.1.—QUANTIFIED BENEFITS FROM ILLNESSES AND MORTALITIES AVOIDED ANNUALLY FROM TURBIDITYPROVISIONS

[$Millions]*

Quantified benefits

Daily drinking water ingestion and baseline Cryptosporidium log-removal assumptions, $Millions, 1999

2.0 log 2.5 log

Low Mild High Low Mid High

Mean Benefit from Avoided Ill-nesses ...................................... $23.9–$42.4 $31.6–$56.0 $32.9–$58.3 $9.5–$16.8 $11.2–$19.8 $12.7–$22.6

10th Percentile ...................... 11.4–20.3 15.2–27.0 14.1–24.9 2.2–3.9 2.8–5.0 4.2–7.590th Percentile ...................... 50.1–88.8 58.8–104.2 56.5–100.2 26.6–47.2 27.6–48.9 33.6–59.5

Mean Benefits from Avoided Mor-talities ....................................... 23.7 31.3 32.5 9.4 11.1 12.6

10th Percentile ...................... 11.3 15.0 13.9 2.2 2.8 4.290th Percentile ...................... 49.6 58.2 55.9 26.3 27.3 33.2

Total Mean Quantified Bene-fits ...................................... 47.6–66.1 62.9–87.3 65.4–90.9 18.9–26.2 22.2–30.9 25.4–35.2

* Totals may not equal due to rounding.

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According to the economic analysisperformed for the LT1ESWTR publishedtoday, the rule is estimated to reducethe mean annual number of illnessescaused by Cryptosporidium in watersystems with improved filtrationperformance by 12,000 to 41,000 casesper year depending upon which of thesix baseline and improvedCryptosporidium removal assumptionswas used, and assuming the 1.2 literdrinking water consumptiondistribution. Based on these values, themean estimated annual benefits ofreducing the illnesses ranges from $9.5million to $58.3 million per year. Theeconomic analysis also indicated thatthe rule could result in a meanreduction of 1 to 5 fatalities each year,

depending upon the varied baseline andimproved removal assumptions. Using amean value of $6.3 million perstatistical life saved, reducing thesefatalities could produce benefits in therange of $9.4 million to $32.5 million.Combining the value of illness andmortalities avoided, the estimate of thetotal quantified annual benefits of theLT1ESWTR range from $18.9 million to$90.9 million. However, this range doesnot incorporate many of the sources ofuncertainty related to quantifyingbenefits, including many benefits theAgency was unable to evaluate.Accordingly, incorporating additionaluncertainties would necessarily increasethe size of the range.

New occurrence data and infectivitydata is currently being evaluated by the

Agency in the context of the Long Term2 Enhanced Surface Water TreatmentRule (LT2ESWTR). The analysis iscurrently ongoing and peer review hasnot been completed. EPA conducted asensitivity analysis in the economicanalysis supporting today’s final rule topredict the effect that new data mayhave on the benefits presented earlier.Table V.2 provides a summary of thissensitivity analysis and depicts thecumulative change to the benefits rangethat each of the four new changes (newoccurrence data, new infectivity data,new morbidity data, and new viabilitydata) could have on benefits. Theeconomic analysis includes a moredetailed analysis using this data.

TABLE V.2.—SUMMARY OF RESULTS OF SENSITIVITY ANALYSIS TO PREDICT EFFECTS OF NEW DATA AND INFORMATIONON RANGE OF BENEFITS

Current EA New occurence data New infectivity data New morbidity data New viability data

Change ....................... No Changes .............. Occurrence changesfrom 4.7 oocyst/Lto 1.06 oocyst/L.

Rate of infection from.00424 to .02317.

Morbidity changesfrom 0.39 to 0.5.

Viability changes from16.4 percent to55.2 percent.

Benefits Range ........... $18.9–$90.9 .............. $5.4–$25.2 ................ $17.3–$74.4 .............. $22.5–$88.0 .............. $51.2–$195.8

2. Non-Quantified Health and Non-Health Related Benefits

The quantified benefits from filterperformance improvements do not fullycapture all the benefits of the turbidityprovision. Even the upper boundestimates, which are based on a cost-of-illness (COI) methodology (expanded toincorporate lost leisure time and lostproductivity while working), may notfully capture the willingness-to-pay toavoid a case of Cryptosporidiosis. Inaddition, the Harrington, et al. studywas conducted in the mid-1980’s in arural community and may not be fullyrepresentative of the current nationalpopulation including individuals withHIV/AIDS and chemotherapy patientsthat are more severely impacted byCryptosporidiosis. If this populationwas more accurately represented, it maybe that the average per-case valuationwould be higher than the rangepresented in this analysis. Further, theturbidity provisions are also expected todecrease the risk of waterborne diseaseoutbreaks. However, the quantifiedbenefits reflect only the reduction inendemic Cryptosporidiosis and not anyoutbreak-related illness or mortalities.

Other disinfection resistant pathogensmay also be removed more efficientlydue to implementation of theLT1ESWTR. Exposure to otherpathogenic protozoa, such as Giardia, orother waterborne bacterial or viral

pathogens are likely to be reduced bythe provisions of this rule as well.

In addition to preventing illnesses,this rule is expected to have other non-health related benefits. During anoutbreak, local governments and watersystems must issue warnings and alertsand may need to provide an alternativesource of water. Systems also facenegative publicity and possibly legalcosts. Businesses have to supply theircustomers and employees withalternative sources of water and some,especially restaurants, may even have totemporarily close. Households also haveto boil their water, purchase water, orobtain water from another source. Astudy of a Giardia outbreak in LuzerneCounty, Pennsylvania showed that thesenon-health related outbreak costs can bequite significant (Harrington et al.,1985). This outbreak resulted in anestimated loss to individuals of $31million to $92 million. Additionallosses were also calculated forrestaurants and bars ($2 million to $7million), government agencies ($0.4million) and the water supply utility ($3million).

The remaining rule provisions(disinfection benchmarking, coveredfinished water reservoirs, inclusion ofCryptosporidium in the GWUDIdefinition, and inclusion ofCryptosporidium in watershed controlrequirements for unfiltered systems)provide additional benefits. However,

EPA is only able to discuss the benefitsof these rule provisions qualitativelybecause of data limitations. Thedisinfection benchmark provision willensure that adequate microbialprotection is in place if a system mustmake changes to its disinfectionpractices as a result of the Stage 1 DBPrule. Covering finished water reservoirswill protect the finished water frombecoming re-contaminated from suchthings as animal or bird droppings,surface water runoff, and algae. IfCryptosporidium is found in groundwater supplies, they will be required tochange treatment practice to preventillness. Finally, by requiringCryptosporidium control in watershedsof unfiltered systems, this will minimizethe potential for illness and may alsolower the overall costs of drinking watertreatment.

D. What Are the Incremental Costs andBenefits?

EPA evaluated the incremental ormarginal costs of today’s final ruleturbidity provision by analyzing variousturbidity limits, 0.3 NTU, 0.2 NTU, and0.1 NTU. For each turbidity limit, EPAdeveloped assumptions about whichprocess changes systems mightimplement to meet the turbidity leveland how many systems would adopteach change. The comparison of totalcompliance cost estimates shows thatcosts are expected to increase

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significantly across other turbiditylimits considered by the Agency. Thetotal cost of a 0.2 NTU limit is 346percent higher than the final rule limitof 0.3 NTU, and a 0.1 NTU limit wouldbe 1,192 percent higher.

E. Are There Benefits From theReduction of Co-OccurringContaminants?

If a system chooses to installtreatment, it may choose a technologythat would also address other drinkingwater contaminants. For example, somemembrane technologies installed toremove bacteria or viruses can reduce oreliminate many other drinking watercontaminants including arsenic.

The technologies used to reduceindividual filter turbidities have thepotential to reduce concentrations ofother pollutants as well. Reductions inturbidity that result from today’sproposed rule are aimed at reducingCryptosporidium by physical removal.However, health risks from Giardialamblia and emerging disinfectionresistant pathogens, such asmicrosporidia, Toxoplasma, andCyclospora, are also likely to be reducedas a result of improvements in turbidityremoval. The frequency and extent thatLT1ESWTR would reduce risk fromother contaminants has not beenquantitatively evaluated because of the

Agency’s lack of data on the removalefficiencies of various technologies foremerging pathogens and the lack of co-occurrence data for microbial pathogensand other contaminants from drinkingwater systems.

F. Is There Increased Risk From OtherContaminants?

It is unlikely that LT1ESWTR willresult in any increased risk from othercontaminants. Improvements in plantturbidity performance will not result inany increases in risk. In fact thedisinfection benchmarking componentof today’s final LT1ESWTR will provideinformation to systems so they canminimize the increased risk frommicrobial contaminants as they takesteps to address risks associated withDBPs under the Stage 1 DBPR.

G. What Are the Uncertainties in theRisk, Benefit and Cost Estimates for theLT1ESWTR?

EPA has included in the economicanalysis, a detailed discussion of thepossible sources of uncertainty in risk,benefit and cost estimates. Some sourcesof possible uncertainty associated withcalculation of risk and benefits includeoccurrence of Cryptosporidium oocystsin source waters and finished waters,reduction of Cryptosporidium oocystsdue to improved treatment, viability and

infectivity of Cryptosporidium oocysts,characterization of risk, and willingnessto reduce risk and avoid costs.Uncertainty associated with costsincludes assumptions with respect totreatment a system might choose toemploy to comply with the rule,assumptions about costs of labor,maintenance, and capital, and thenumber of systems expected toundertake certain activities. The Agencybelieves that the risks, benefits, andcosts have been accurately portrayed.Discussions and analyses of risks,benefits, and costs in the economicanalysis indicate where uncertainty maybe introduced and to the extentpossible, the effect uncertainty mayhave on analysis (USEPA, 2001a).

H. What Is the Benefit/CostDetermination for the LT1ESWTR?

The Agency has determined that thebenefits of the LT1ESWTR justify thecosts. As shown in Table V.3, thequantified net benefits of this rule basedon the Agency’s estimate range from$20.6 million to $51.4 million using the3 percent discount rate ($25.9 million to$46.1 million at the 7 percent discountrate). Additionally, EPA believes thatquantified net benefits would be largerif both unquantified benefits and costswere able to be monetized.

TABLE V.3.—ANNUALIZED NET BENEFITS OF THE LT1ESWTR, MILLIONS, 1999 DOLLARS

Benefit rangeCosts using a 3

percent dis-count rate

Costs using a 7percent dis-count rate

Net benefits (3percent)

Net benefits (7percent)

Estimate of Benefits ................................................... $18.9–$90.9 $39.5 $44.8 $¥20.6–$51.4 $¥25.9–$46.1

VI. Other Requirements

A. Regulatory Flexibility Act (RFA), asAmended by the Small BusinessRegulatory Enforcement Fairness Act of1996 (SBREFA), 5 U.S.C. 601 et seq.

The RFA generally requires an agencyto prepare a regulatory flexibilityanalysis of any rule subject to noticeand comment rulemaking requirementsunder the Administrative Procedure Actor any other statute unless the agencycertifies that the rule will not have asignificant economic impact on asubstantial number of small entities.Small entities include small businesses,small organizations, and smallgovernmental jurisdictions.

The RFA provides default definitionsfor each type of small entity. It alsoauthorizes an agency to use alternativedefinitions for each category of smallentity, ‘‘which are appropriate to theactivities of the agency’’ after proposing

the alternative definition(s) in theFederal Register and taking comment. 5U.S.C. 601(3)–(5). In addition to theabove, to establish an alternative smallbusiness definition, agencies mustconsult with SBA’s Chief Counsel forAdvocacy.

For purposes of assessing the impactsof today’s rule on small entities, EPAconsidered small entities to be PWSsserving fewer than 10,000 persons. Thisis the cut-off level specified by Congressin the 1996 Amendments to the SDWAfor small system flexibility provisions.In accordance with the RFArequirements, EPA proposed using thisalternative definition in the FederalRegister (63 FR 7620, February 13,1998), requested comment, consultedwith the Small Business Administration(SBA), and expressed its intention touse the alternative definition for allfuture drinking water regulations in theConsumer Confidence Reports

regulation (63 FR 44511, August 19,1998). As stated in that final rule, thealternative definition would be appliedto this regulation as well.

After considering the economicimpacts of today’s final rule on smallentities, I certify that this action will nothave a significant economic impact ona substantial number of small entities.

In accordance with section 603 of theRFA, EPA convened a Small BusinessAdvocacy Review (SBAR) Panel toobtain advice and recommendationsfrom representatives of small entitiesthat would potentially be regulated bythe rule in accordance with section609(b) of the RFA. A detailed discussionof the Panel’s advice andrecommendations is found in the PanelReport found in the docket for today’sfinal rule (USEPA, 1998k). The Panelrecommendations emphasized the needto provide small systems flexibility. TheAgency has structured today’s final

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LT1ESWTR with an emphasis onproviding flexibility and reducingburden for small systems. For example,the Agency originally contemplatedrequiring four quarters of TTHM andHAA5 monitoring and disinfectionprofiling based on daily measurements.Today’s final rule requires profilingbased on weekly measurements andallows systems the option of using onequarter of TTHM and HAA5 monitoringto opt-out of profiling. Today’s rule alsoprovides systems with two or fewerfilters the flexibility to monitorcombined filter effluent in lieu ofindividual filter turbidity monitoring,effectively allowing these systems toreduce their recordkeeping burden. Acomplete summary of the Panel’srecommendations is presented in theproposal (65 FR 19046, 19127–19130).

While EPA could have certified theproposed rule based on the proposedrule requirements, the Agency originallydeveloped an IRFA (see 65 FR 19046,19126–19127) and convened an SBARPanel because several of the additionalalternatives EPA was requestingcomment on would have resulted insubstantial costs for small systemsthereby preventing the Agency fromcertifying. While EPA included theseadditional alternatives in the proposaland estimated costs in the economicanalysis for the proposal, the Agency re-evaluated the economic effects on smallentities after publication of the April 10,2000 LT1ESWTR proposal using therule requirements of today’s final ruleand was able to certify that today’s finalrule will not have a significanteconomic impact on a substantialnumber of small entities.

EPA’s analysis showed that of theapproximately 11,000 small entitiespotentially affected by the LT1ESWTR,over 5,000 are expected to incur averageannualized costs of less than $70 dollars(0.003 percent of average annualrevenue) while slightly more than 3,000are expected to incur averageannualized costs of less than $850dollars (0.03 percent of average annualrevenue). Of the remaining systems,approximately 500 systems are expectedto incur average annualized costs ofapproximately $2,500 dollars (0.1percent of average annual revenue),approximately 2,000 systems areexpected to incur average annualizedcosts of approximately $13,000 dollars(0.6 percent of average annual revenue).Less than 100 systems are expected toincur average annualized costs ofapproximately $15,700 dollars (0.7percent of average annual revenue). TheAgency has included a detaileddescription of this analysis in theRegulatory Flexibility Screening

Analysis prepared for the rule (USEPA,2000e).

B. Paperwork Reduction ActThe Office of Management and Budget

(OMB) has approved the informationcollection requirements contained inthis rule under the provisions of thePaperwork Reduction Act, 44 U.S.C.3501 et seq, and has assigned OMBcontrol number 2040–0229. Theinformation collected as a result of thisrule will allow the States and EPA todetermine appropriate requirements forspecific systems, in some cases, and toevaluate compliance with the rule. Forthe first three years after February 13,2002, the major informationrequirements are related to disinfectionprofiling activities. The informationcollection requirements in §§ 141.530–141.536, 141.540–141.544, 141.550–141.553, 141.560–141.564, and 141.570–141.571, for systems, and §§ 142.14 and142.16, for States, are mandatory. Theinformation collected is notconfidential. The final estimate ofaggregate annual average burden hoursfor LT1ESWTR is 330,329. Annualaverage aggregate cost estimate is$1,583,538 for capital (expenditures formonitoring equipment), and $1,919,563for operation and maintenanceincluding lab costs (which is a purchaseof service). The burden hours perresponse is 21.8. The frequency ofresponse (average responses perrespondent) is 2.8 annually. Theestimated number of likely respondentsis 5,404 (the product of burden hoursper response, frequency, andrespondents does not total the annualaverage burden hours due to rounding).

Burden means the total time, effort, orfinancial resources expended by personsto generate, maintain, retain, or discloseor provide information to or for aFederal agency. This includes the timeneeded to review instructions; develop,acquire, install, and utilize technologyand systems for the purposes ofcollecting, validating, and verifyinginformation; processing andmaintaining information, and disclosingand providing information; adjust theexisting ways to comply with anypreviously applicable instructions andrequirements; train personnel to be ableto respond to a collection ofinformation; search data sources;complete and review the collection ofinformation; and transmit or otherwisedisclose the information.

An Agency may not conduct orsponsor, and a person is not required torespond to a collection of informationunless it displays a currently valid OMBcontrol number. The OMB controlnumbers for EPA’s regulations are listed

in 40 CFR part 9 and 48 CFR Chapter15. EPA is amending the table in 40 CFRpart 9 of currently approved ICR controlnumbers issued by OMB for variousregulations to list the informationrequirements contained in this finalrule.

C. Unfunded Mandates Reform Act

1. Summary of UMRA Requirements

Title II of the Unfunded MandatesReform Act of 1995 (UMRA), PublicLaw 104–4, establishes requirements forFederal agencies to assess the effects oftheir regulatory actions on State, local,and Tribal governments and the privatesector. Under UMRA section 202, EPAgenerally must prepare a writtenstatement, including a cost-benefitanalysis, for proposed and final ruleswith ‘‘Federal mandates’’ that mayresult in expenditures by State, local,and Tribal governments, in theaggregate, or by the private sector, of$100 million or more in any one year.Before promulgating an EPA rule forwhich a written statement is needed,section 205 of the UMRA generallyrequires EPA to identify and consider areasonable number of regulatoryalternatives and adopt the least costly,most cost-effective or least burdensomealternative that achieves the objectivesof the rule. The provisions of section205 do not apply when they areinconsistent with applicable law.Moreover, section 205 allows EPA toadopt an alternative other than the leastcostly, most cost effective or leastburdensome alternative if theAdministrator publishes with the finalrule an explanation why that alternativewas not adopted.

Before EPA establishes any regulatoryrequirements that may significantly oruniquely affect small governments,including Tribal governments, it musthave developed, under section 203 ofthe UMRA, a small government agencyplan. The plan must provide fornotifying potentially affected smallgovernments, enabling officials ofaffected small governments to havemeaningful and timely input in thedevelopment of EPA regulatoryproposals with significant Federalintergovernmental mandates andinforming, educating, and advisingsmall governments on compliance withthe regulatory requirements.

EPA has determined that this ruledoes not contain a Federal mandate thatmay result in expenditures of $100million or more for State, local andTribal governments, in the aggregate, orthe private sector in any one year. Theestimated annual cost of this rule is$39.5 million. Thus today’s rule is not

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subject to the requirements of sections202 and 205 of the UMRA.

EPA has determined that this rulecontains no regulatory requirements thatmight significantly or uniquely affectsmall governments. Of theapproximately 6,500 small governmententities potentially affected by theLT1ESWTR, approximately 3,000 areexpected to incur average annualizedcosts of less than $70 dollars (0.003percent of average annual revenue)while approximately 2,000 are expectedto incur average annualized costs of lessthan $850 dollars (0.03 percent ofaverage annual revenue). Of theremaining systems, less than 300 areexpected to incur average annualizedcosts of approximately $2,500 dollars(0.1 percent of average annual revenue),approximately 1,200 systems areexpected to incur average annualizedcosts of approximately $13,000 dollars(0.6 percent of average annual revenue).Less than 100 systems are expected toincur average annualized costs ofapproximately $15,700 dollars (0.7percent of average annual revenue).While today’s final rule only applies tosystems serving fewer than 10,000, it isnot unique as it provides a comparablelevel of health protection to individualsserved by small systems as the IESWTRprovided to individuals served by largesystems. While there are smalldifferences between the LT1ESWTR andIESWTR, these differences reflect aneffort to reduce burden for smallsystems while still maintaining acomparable level of health protection.Thus, today’s rule is not subject to therequirements of section 203 of UMRA.

Nevertheless, EPA has tried to ensurethat State, local, and Tribal governmentshad opportunities to provide comment.EPA consulted with small governmentsto address impacts of regulatoryrequirements in the rule that mightsignificantly or uniquely affect smallgovernments. As discussed next, avariety of stakeholders, including smallgovernments, were provided theopportunity for timely and meaningfulparticipation in the regulatorydevelopment process. EPA used theseopportunities to notify potentiallyaffected small governments of regulatoryrequirements being considered.

EPA began outreach efforts to developthe LT1ESWTR in the summer of 1998.Two public stakeholder meetings,which were announced in the FederalRegister, were held on July 22–23, 1998,in Lakewood, Colorado, and on March3–4, 1999, in Dallas, Texas.Stakeholders include representatives ofState, local and Tribal governments,environmental groups and publiclyowned and privately owned public

water systems. In addition to thesemeetings, EPA has held several formaland informal meetings withstakeholders including the Associationof State Drinking Water Administratorsand representatives of State and localelected officials. A summary of eachmeeting and attendees is available in thepublic docket for this rule. EPA alsoconvened a Small Business AdvocacyReview (SBAR) Panel in accordancewith the RFA, as amended by the SmallBusiness Regulatory EnforcementFairness Act (SBREFA) to address smallentity concerns including those of smalllocal governments. The SBAR Panelallows small regulated entities toprovide input to EPA early in theregulatory development process. Inearly June 1999, EPA mailed aninformal draft of the LT1ESWTRpreamble to the approximately 100stakeholders who attended one of thepublic stakeholder meetings. Membersof trade associations and the SBREFAPanel also received the draft preamble.EPA received valuable suggestions andstakeholder input from 15 Staterepresentatives, trade associations,environmental interest groups, andindividual stakeholders. The majority ofconcerns dealt with reducing burden onsmall systems and maintainingflexibility.

To inform and involve Tribalgovernments in the rulemaking process,EPA presented the LT1ESWTR at threevenues: the 16th Annual ConsumerConference of the National IndianHealth Board, the annual conference ofthe National Tribal EnvironmentalCouncil, and the EPA/Inter TribalCouncil of Arizona, Inc. Tribalconsultation meeting. Over 900attendees representing Tribes fromacross the country attended the NationalIndian Health Board’s ConsumerConference and over 100 Tribes wererepresented at the annual conference ofthe National Tribal EnvironmentalCouncil. At the first two conferences, anEPA representative conducted twoworkshops on EPA’s drinking waterprogram and upcoming regulations,including the LT1ESWTR.

At the EPA/Inter Tribal Council ofArizona meeting, representatives from15 Tribes participated. The presentationmaterials and meeting summary weresent to over 500 Tribes and Tribalorganizations. Additionally, EPAcontacted each of the 12 NativeAmerican Drinking Water StateRevolving Fund Advisors to invitethem, and representatives of theirorganizations to the stakeholdermeetings described previously.

During the comment period fortoday’s final rule, the Agency held a

public meeting in Washington D.C. onApril 14, 2000. Additionally, theproposed rule was either presented ordiscussed in nearly 50 meetings acrossthe U.S. Finally, EPA mailedapproximately 200 copies of theproposed rule to stakeholders requestingcomment. EPA received 67 commentsfrom a variety of stakeholders including24 States, 21 municipalities, one Tribe,one elected official, two consultants,eight trade groups, and four privateindustries.

In addition, EPA will educate, inform,and advise small systems, includingthose run by small governments, aboutthe LT1ESWTR requirements. TheAgency is developing plain-Englishguidance that will explain what actionsa small entity must take to comply withthe rule. Also, the Agency hasdeveloped a fact sheet that conciselydescribes various aspects andrequirements of the LT1ESWTR. Thisfact sheet is available by calling the SafeDrinking Water Hotline at 800–426–4791.

D. National Technology Transfer andAdvancement Act

As noted in the proposed rule, section12(d) of the National TechnologyTransfer and Advancement Act of 1995(NTTAA), Public Law No. 104–113,section 12(d) (15 U.S.C. 272 note),directs EPA to use voluntary consensusstandards in its regulatory activitiesunless to do so would be inconsistentwith applicable law or otherwiseimpractical. Voluntary consensusstandards are technical standards (e.g.,materials specifications, test methods,sampling procedures, and businesspractices) that are developed or adoptedby voluntary consensus standardsbodies. The NTTAA directs EPA toprovide Congress, through the Office ofManagement and Budget, explanationswhen the Agency decides not to useavailable and applicable voluntaryconsensus standards.

Today’s rule does not establish anytechnical standards, thus, NTTAA doesnot apply to this rule. It should benoted, however, that systems complyingwith this rule need to use one of threepreviously approved technicalstandards already included in § 141.74(a). Method 2130B (APHA, 1995), ispublished in Standard Methods for theExamination of Water and Wastewater(19th ed.) and is a voluntary consensusstandard. The Great Lakes InstrumentMethod 2, has been approved by USEPAas an alternate test procedure (GreatLakes Instruments, 1992). EPA Method180.1 for turbidity measurement waspublished in August 1993 in Methodsfor the Determination of Inorganic

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Substances in Environmental Samples(EPA–600/R–93–100) (USEPA, 1993).

Today’s final rule also requirescalibration of the individualturbidimeter to be conducted usingprocedures specified by themanufacturer. EPA encouragedcomments on this aspect of therulemaking and specifically invited thepublic to identify potentially applicablevoluntary consensus standards and toexplain why such standards should beused in this regulation. EPA received nocomments on this issue.

E. Executive Order 12866: RegulatoryPlanning and Review

Under Executive Order 12866 (58 FR51735, October 4, 1993), the Agencymust determine whether the regulatoryaction is ‘‘significant’’ and thereforesubject to OMB review and therequirements of the Executive Order.The Order defines ‘‘significantregulatory action’’ as one that is likelyto result in a rule that may:

(1) Have an annual effect on theeconomy of $100 million or more oradversely affect in a material way theeconomy, a sector of the economy,productivity, competition, jobs, theenvironment, public health or safety, orState, local, Tribal governments orcommunities;

(2) Create a serious inconsistency orotherwise interfere with an action takenor planned by another agency;

(3) Materially alter the budgetaryimpact of entitlements, grants, user fees,or loan programs or the rights andobligations of recipients thereof, or;

(4) Raise novel legal or policy issuesarising out of legal mandates, thePresident’s priorities, or the principlesset forth in the Executive Order.

Pursuant to the terms of the ExecutiveOrder 12866, it has been determinedthat this rule is a ‘‘significant regulatoryaction.’’ As such, this action wassubmitted to OMB for review. Changesmade in response to OMB suggestions orrecommendations are documented inthe public record.

F. Executive Order 12898:Environmental Justice

Executive Order 12898 establishes aFederal policy for incorporatingenvironmental justice into Federalagency missions by directing agencies toidentify and address disproportionatelyhigh and adverse human health orenvironmental effects of its programs,policies, and activities on minority andlow-income populations. The Agencyhas considered environmental justicerelated issues concerning the potentialimpacts of this action and consulted

with minority and low-incomestakeholders.

This preamble has discussed how theIESWTR served as a template for thedevelopment of the LT1ESWTR. Assuch, the Agency also built on theefforts conducted during the IESWTRsdevelopment to comply with ExecutiveOrder 12898. On March 12, 1998, theAgency held a stakeholder meeting toaddress various components of pendingdrinking water regulations and howthey may impact sensitive sub-populations, minority populations, andlow-income populations. Topicsdiscussed included treatmenttechniques, costs and benefits, dataquality, health effects, and theregulatory process. Participantsincluded national, State, Tribal,municipal, and individual stakeholders.EPA conducted the meetings by videoconference call between 11 cities. Thismeeting was a continuation ofstakeholder meetings that started in1995 to obtain input on the Agency’sDrinking Water Programs. The majorobjectives for the March 12, 1998meeting were to:—Solicit ideas from stakeholders on

known issues concerning currentdrinking water regulatory efforts;

—Identify key issues of concern tostakeholders, and;

—Receive suggestions from stakeholdersconcerning ways to increaserepresentation of communities inEPA’s Office of Water drinking waterregulatory efforts.In addition, EPA developed a plain-

English guide specifically for thismeeting to assist stakeholders inunderstanding the multiple andsometimes complex issues surroundingdrinking water regulation.

The LT1ESWTR applies tocommunity water systems, non-transient non-community watersystems, and transient non-communitywater systems that use surface water orGWUDI as their source water for PWSsserving less than 10,000 people. Theserequirements will also be consistentwith the protection already afforded topeople being served by systems serving10,000 or more persons.

G. Executive Order 13045: Protection ofChildren From Environmental HealthRisks and Safety Risks

Executive Order 13045: ‘‘Protection ofChildren from Environmental HealthRisks and Safety Risks’’ (62 FR 19885,April 23, 1997) applies to any rule that:(1) Is determined to be economicallysignificant as defined under ExecutiveOrder 12866, and; (2) concerns anenvironmental health or safety risk that

EPA has reason to believe may have adisproportionate effect on children. Ifthe regulatory action meets both criteria,the Agency must evaluate theenvironmental health or safety effects ofthe planned rule on children andexplain why the planned regulation ispreferable to other potentially effectiveand reasonably feasible alternativesconsidered by the Agency.

While this final rule is not subject tothe Executive Order because it is noteconomically significant as defined inExecutive Order 12866, we nonethelesshave reason to believe that theenvironmental health or safety riskaddressed by this action may have adisproportionate effect on children. Asa matter of EPA policy, we thereforehave assessed the environmental healtheffects of Cryptosporidium on children.The results of this assessment arecontained in the LT1ESWTR economicanalysis (USEPA, 2001a). A copy of theanalysis and supporting documents arefound in the public docket for today’sfinal rule (W–99–10, Final Long Term 1Enhanced Surface Water TreatmentRule. The docket is available for publicreview at EPA’s Drinking Water Docket:401 M Street, SW., Rm. EB57,Washington, DC 20460.

The risk of illness and death due tocryptosporidiosis depends on severalfactors, including age, nutrition,exposure, genetic variability, diseaseand immune status of the individual.Mortality resulting from diarrhea showsthe greatest risk of mortality occurringamong the very young and elderly(Gerba et al., 1996). ForCryptosporidium, young children are avulnerable population subject toinfectious diarrhea (CDC 1994).Cryptosporidiosis is prevalentworldwide, and its occurrence is higherin children than in adults (Fayer andUngar, 1986).

Cryptosporidiosis appears to be moreprevalent in populations, such asinfants, that may not have establishedimmunity against the disease and maybe in greater contact withenvironmentally contaminated surfaces(DuPont, et al., 1995). An infected childmay spread the disease to other childrenor family members. Evidence of suchsecondary transmission ofcryptosporidiosis from children tohousehold and other close contacts hasbeen found in a number of outbreakinvestigations (Casemore, 1990; Cordellet al., 1997; Frost et al., 1997). Chapelleet al., (1999) found that prior exposureto Cryptosporidium through theingestion of a low oocyst dose providesprotection from infection and illness.However, it is not known whether thisimmunity is life-long or temporary. Data

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also indicate that either mothers confershort term immunity to their children orthat babies have reduced exposure toCryptosporidium, resulting in adecreased incidence of infection duringthe first year of life. For example, in asurvey of over 30,000 stool sampleanalyses from different patients in theUnited Kingdom, the one to five yearage group suffered a much higherinfection rate than individuals less thanone year of age. For children under oneyear of age, those older than six monthsof age showed a higher rate of infectionthan individuals aged fewer than sixmonths (Casemore, 1990).

EPA has not been able to quantify thehealth effects for children as a result ofCryptosporidium-contaminateddrinking water. However, the result ofthe LT1ESWTR will be a reduction inthe risk of illness for the entirepopulation, including children. Becauseavailable evidence indicates thatchildren may be more vulnerable toCryptosporidiosis than the rest of thepopulation, the LT1ESWTR would,therefore, result in greater risk reductionfor children than for the generalpopulation.

H. Consultations With the ScienceAdvisory Board, National DrinkingWater Advisory Council, and theSecretary of Health and Human Services

In accordance with section 1412 (d)and (e) of the SDWA, the Agencyconsulted with the National DrinkingWater Advisory Council (NDWAC), theSecretary of Health and HumanServices, and the EPA Science AdvisoryBoard (SAB) on the proposedLT1ESWTR. None of the threeconsultations resulted in substantivecomments on the LT1ESWTR.

On March 13 and 14, 2000 inWashington, DC, the Agency met withSAB during meetings open to the publicwhere several of the Agency’s drinkingwater rules were discussed. A copy ofthe SAB’s comments are found in thedocket (USEPA, 2000l). Comments onthe LT1ESWTR were generallysupportive.

On May 10, 2000 in San Francisco,California, the Agency met withNDWAC. A copy of the materialspresented to the NDWAC, as well as thecharge presented to the council arefound in the docket (USEPA, 2000f,NDWAC, 2000).

EPA invited the Secretary of Healthand Human Services to the April 14th,2000 informational meeting regardingthe proposed Long Term 1 EnhancedSurface Water Treatment Rule andconsulted with the Centers for DiseaseControl (CDC) during a June 20, 2000conference call with the Centers’

Working Group on WaterborneCryptosporidiosis. The meeting notesfor that call are found in the docket(CDC, 2000). CDC’s role as an Agency ofthe Department of Health and HumanServices is to provide a system of healthsurveillance to monitor and prevent theoutbreak of diseases. With the assistanceof States and other partners, CDC guardsagainst international diseasetransmission, maintains national healthstatistics, and provides forimmunization services and supportsresearch into disease and injuryprevention.

I. Executive Order 13132: ExecutiveOrders on Federalism

Executive Order 13132, entitled‘‘Federalism’’ (64 FR 43255, August 10,1999), requires EPA to develop anaccountable process to ensure‘‘meaningful and timely input by Stateand local officials in the development ofregulatory policies that have federalismimplications.’’ ‘‘Policies that havefederalism implications’’ is defined inthe Executive Order to includeregulations that have ‘‘substantial directeffects on the States, on the relationshipbetween the national government andthe States, or on the distribution ofpower and responsibilities among thevarious levels of government.’’

This final rule does not havefederalism implications. It will not havesubstantial direct effects on the States,on the relationship between the nationalgovernment and the States, or on thedistribution of power andresponsibilities among the variouslevels of government, as specified inExecutive Order 13132. Today’s finalrule does not have a substantial directeffect on local and State governmentsbecause it is not expected to imposesubstantial direct compliance costs. Therule imposes annualized compliancecosts on State and local governments ofapproximately $30.6 million. $6.4million of these costs are attributable toStates, while $24.2 million isattributable to local governmentsserving fewer than 10,000 persons. Asdescribed in Section V1.A of thepreamble for today’s final rule, this rulewill not have a significant economicimpact on a substantial number of smallentities, including small governments.Furthermore, the rule does not have asubstantial direct effect on therelationship between the nationalgovernment and the States, or thedistribution of power andresponsibilities among the variouslevels of government as specified inExecutive Order 13132 because the ruledoes not change the current roles andrelationships of the Federal government,

State governments and localgovernments in implementing drinkingwater programs. Thus Executive Order13132 does not apply to this rule.Although the Executive Order does notapply to this rule, EPA did consult withState and local officials in developingthis rule. In addition to our outreachefforts described earlier, on May 30,2000, the Agency held a meeting inWashington, DC with tenrepresentatives of elected State andlocal officials to discuss how newFederal drinking water regulations(LT1ESWTR, FBRR, Ground Water Rule,Radon Rule, Radionuclides Rule, andArsenic Rule) may affect State, county,and local governments. Throughout theconsultation, stakeholders asked EPAfor clarification of basic concepts andrule elements. EPA addressed theseissues throughout the consultation andprovided background and clarificationto promote better understanding of theissues. For example, stakeholders askedEPA to describe what Cryptosporidiumis and how individuals are diagnosedwith cryptosporidiosis. A detailedsummary of this consultation meetingand the concerns raised is found in thedocket (USEPA, 2000g). No significantconcerns were raised regarding theLT1ESWTR.

J. Executive Order 13175: Consultationand Coordination With Indian TribalGovernments

On November 6, 2000, the Presidentissued Executive Order 13175 (65 FR67249) entitled, ‘‘Consultation andCoordination with Indian TribalGovernments.’’ Executive Order 13175took effect on January 6, 2001, andrevoked Executive Order 13084 (alsoentitled Consultation and Coordinationwith Indian Tribal Governments.’’) as ofthat date. However, EPA developed andproposed this final rule when ExecutiveOrder 13084 was in effect, and beforethe effective date of the consultationrequirements of Executive Order 13175.Therefore, the consultationrequirements of Executive Order 13084apply to this rule.

Under Executive Order 13084, EPAcould not issue a regulation that was notrequired by statute, that significantly oruniquely affected the communities ofIndian Tribal governments, and thatimposed substantial direct compliancecosts on those communities, unless theFederal government provided the fundsnecessary to pay the direct compliancecosts incurred by the Tribalgovernments, or EPA consulted withthose governments.

Executive Order 13084 required EPAto provide to the Office of Managementand Budget, in a separately identified

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section of the preamble to the rule, adescription of the extent of EPA’s priorconsultation with representatives ofaffected Tribal governments, a summaryof the nature of their concerns, and astatement supporting the need to issuethe regulation. In addition, ExecutiveOrder 13084 required EPA to develop aneffective process permitting electedofficials and other representatives ofIndian Tribal governments ‘‘to providemeaningful and timely input in thedevelopment of regulatory policies onmatters that significantly or uniquelyaffect their communities.’’

EPA has concluded that this rule willnot significantly or uniquely affectcommunities of Indian Tribalgovernments, and will not imposesubstantial direct compliance costs onsuch communities. This rule will affectapproximately 70 of the 700 total Tribaldrinking water systems. Of these 70systems, half are estimated to incurannualized compliance costs of lessthan $70 per year (0.003 percent ofaverage annual revenue) andapproximately 20 systems are estimatedto incur annualized compliance costs ofless than $850 per year (0.03 percent ofaverage annual revenue). The remainingsystems would incur an estimatedannualized compliance costs of lessthan $13,000, or 0.6 percent of averageannual revenue.

Nonetheless, EPA providedrepresentatives of Tribal governmentswith several opportunities to becomeknowledgeable of the proposed rule andto provide meaningful and timely inputin its development. EPA began outreachefforts to develop the LT1ESWTR in thesummer of 1998 as discussed in detailabove in the UMRA and Federalismsections. To inform and involve therepresentatives of Tribal governmentsspecifically, EPA presented theLT1ESWTR at three venues: The 16thAnnual Consumer Conference of the

National Indian Health Board, theannual conference of the National TribalEnvironmental Council, and the EPA/Inter Tribal Council of Arizona, Inc.Tribal consultation meeting. Summariesof the meetings have been included inthe public docket for this rulemaking.EPA’s consultation, the nature of theTribal concerns, and the positionsupporting the need for this rule arediscussed in Section VI.C., whichaddresses compliance with UMRA.

Over 900 Tribal representatives fromacross the country attended the NationalIndian Health Board’s ConsumerConference and over 100 Tribes wererepresented at the annual conference ofthe National Tribal EnvironmentalCouncil. At the first two conferences, anEPA representative conducted twoworkshops on EPA’s drinking waterprogram and upcoming regulations,including the LT1ESWTR. At the EPA/Inter Tribal Council of Arizona meeting,representatives from 15 Tribesparticipated. The presentation materialsand meeting summary were sent to over500 Tribes and Tribal organizations.Additionally, EPA contacted andinvited each of the 12 Native AmericanDrinking Water State Revolving FundAdvisors to attend the meetingsdescribed above.

During the comment period fortoday’s final rule, the Agency held apublic meeting in Washington, DC onApril 14, 2000 which was announced inthe Federal Register. Additionally, theproposed rule was either presented ordiscussed in nearly 50 meetings acrossthe country. Finally, EPA mailedapproximately 200 copies of theproposed rule to stakeholders, includingTribal representatives, requestingcomment. EPA received 67 comments,one of which was from a Tribe. TheTribe indicated that they operated onesurface water treatment plant and askedseveral clarifying questions with respect

to optional monitoring and turbiditymonitoring.

K. Likely Effect of Compliance With theLT1ESWTR on the Technical, Financial,and Managerial Capacity of PublicWater Systems

Section 1420(d)(3) of the SDWA asamended requires that, in promulgatinga NPDWR, the Administrator shallinclude an analysis of the likely effectof compliance with the regulation onthe technical, financial, and managerialcapacity of public water systems. Thisanalysis can be found in the LT1ESWTReconomic analysis (USEPA, 2001a).Overall water system capacity is definedin EPA guidance (USEPA, 1998j) as theability to plan for, achieve, andmaintain compliance with applicabledrinking water standards. Capacity hasthree components: Technical,managerial, and financial. Technicalcapacity is the physical and operationalability of a water system to meet SDWArequirements. Technical capacity refersto the physical infrastructure of thewater system, including the adequacy ofsource water and the adequacy oftreatment, storage, and distributioninfrastructure. It also refers to the abilityof system personnel to adequatelyoperate and maintain the system and tootherwise implement requisite technicalknowledge. Managerial capacity is theability of a water system to conduct itsaffairs to achieve and maintaincompliance with SDWA requirements.Managerial capacity refers to thesystem’s institutional andadministrative capabilities. Financialcapacity is a water system’s ability toacquire and manage sufficient financialresources to allow the system to achieveand maintain compliance with SDWArequirements. Technical, managerial,and financial capacity can be assessedthrough key issues and questions,including:

Technical Capacity

Source water adequacy .................. Does the system have a reliable source of drinking water? Is the source of generally good quality and ade-quately protected?

Infrastructure adequacy .................. Can the system provide water that meets SDWA standards? What is the condition of its infrastructure, in-cluding well(s) or source water intakes, treatment, storage, and distribution? What is the infrastructure’slife expectancy? Does the system have a capital improvement plan?

Technical knowledge and imple-mentation.

Is the system’s operator certified? Does the operator have sufficient technical knowledge of applicablestandards? Can the operator effectively implement this technical knowledge? Does the operator under-stand the system’s technical and operational characteristics? Does the system have an effective oper-ation and maintenance program?

Managerial Capacity

Ownership accountability ................ Are the system owner(s) clearly identified? Can they be held accountable for the system?Staffing and organization ................ Are the system operator(s) and manager(s) clearly identified? Is the system properly organized and

staffed? Do personnel understand the management aspects of regulatory requirements and system op-erations? Do they have adequate expertise to manage water system operations? Do personnel have thenecessary licenses and certifications?

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Effective external linkages .............. Does the system interact well with customers, regulators, and other entities? Is the system aware of avail-able external resources, such as technical and financial assistance?

Financial Capacity

Revenue sufficiency ........................ Do revenues cover costs? Are water rates and charges adequate to cover the cost of water?Credit worthiness ............................ Is the system financially healthy? Does it have access to capital through public or private sources?Fiscal management and controls .... Are adequate books and records maintained? Are appropriate budgeting, accounting, and financial plan-

ning methods used? Does the system manage its revenues effectively?

Systems not making significantmodifications to the treatment processto meet LT1ESWTR requirements arenot expected to require significantlyincreased technical, financial, ormanagerial capacity. As notedpreviously, less than 1 percent ofaffected systems are expected to incurannual costs exceeding 1 percent oftheir annual revenue as described inSection VI.A. Accordingly, mostsystems are not expected to requiresignificantly increased technical,financial, or managerial capacity. EPAdoes recognize that a very small numberof facilities may realize some technical,managerial, or financial capacityconcerns as a result of the rule. EPAworks closely with organizations suchas the National Rural Water Associationand the American Water WorksAssociation to develop technical andmanagerial tools, materials, andassistance to aid small systems.Additionally, the Safe Drinking WaterAct, as amended in 1996, establishedthe Drinking Water State RevolvingFund (DWSRF) to make funds availableto drinking water systems to financeinfrastructure improvements. Theprogram emphasizes providing funds tosmall and disadvantaged communitiesand to programs that encouragepollution prevention as a tool forensuring safe drinking water.

L. Plain Language

Executive Order 12866 requires eachagency to write its rules in plainlanguage. Readable regulations help thepublic find requirements quickly andunderstand them easily. They increasecompliance, strengthen enforcement,and decrease mistakes, frustration,phone calls, appeals, and distrust ofgovernment. Of the several techniquestypically utilized for writing readably,using a question and answer format, andusing the word ’you’ for whoever mustcomply, do the most to improve the lookand sound of a regulation. Today’spreamble and final rule use both ofthese principles and was developedusing a plain language format, except inthe case of modifications or additions toexisting subparts of parts 141 and 142,where such a format would not fit intoexisting rule language. The Agency

requested comment on this approachand several commenter’s indicated thatthe proposal was clear and easy tounderstand.

M. Congressional Review ActThe Congressional Review Act, 5

U.S.C. 801 et seq., as added by the SmallBusiness Regulatory EnforcementFairness Act of 1996, generally providesthat before a rule may take effect, theagency promulgating the rule mustsubmit a rule report, which includes acopy of the rule, to each House of theCongress and to the Comptroller Generalof the United States. EPA will submit areport containing this rule and otherrequired information to the U.S. Senate,the U.S. House of Representatives, andthe Comptroller General of the UnitedStates prior to publication of the rule inthe Federal Register. A major rulecannot take effect until 60 days after itis published in the Federal Register.This action is not a ‘‘major rule’’ asdefined by 5 U.S.C. 804(2). This rulewill be effective February 13, 2002.

N. Executive Order 13211: ActionsConcerning Regulations ThatSignificantly Affect Energy Supply,Distribution, or Use

This rule is not a ‘‘significant energyaction’’ as defined in Executive Order13211, Actions Concerning RegulationsThat Significantly Affect Energy Supply,Distribution, or Use’’ 66 FR 28355, (May22, 2001), because it is not likely to havea significant adverse effect on thesupply, distribution, or use of energy.The requirements in this rule wouldhave a negligible impact upon theenergy demands of some public watersupply systems. Therefore, there is nota significant adverse effect on energysupply, distribution, or use.

VII. References

Adham, S., Gagliado, P., Smith, D., Ross, D.,Gramith, K., and Trussell, R. 1998.Monitoring of Reverse Osmosis for VirusRejection, Proceedings Water Qualityand Technology Conference. 9pp.

American Water Works AssociationCommittee Report. 1983. Deterioration ofwater quality in large distributionreservoirs (open reservoirs). AWWACommittee on Control of Water Qualityin Transmission and DistributionSystems. J. AWWA. June 1983, 313–318.

Amirtharajah, A. 1988. Some theoretical andconceptual views of filtration. J. AWWA.(80:12: 36–46).

APHA. 1995. 19th Edition of StandardMethods for the Examination of Waterand Wastewater, 1995. American PublicHealth Association. 1015 15th StreetNW, Washington D.C. 20005. (Includesmethod 2130A, B).

Atherholt, T., LeChevallier, M., Norton, W.,and Rosen, J. 1998. Effect of rainfall onGiardia and crypto. J.AWWA (90:9:66–80).

Bucklin, K., Amirtharajah, A., and Cranston,K. 1988. The characteristics of initialeffluent quality and its implications forthe filter-to-waste procedure. AWWARF.Denver, 158pp.

Casemore, D. 1990. Epidemiological aspectsof human cryptosporidiosis. Epidemiol.Infect. (104:1–28).

CDC 1994. Addressing Emerging InfectiousDisease Threats: A Prevention Strategyfor the United States. ExecutiveSummary. P. 1–3.

CDC 2000. Notes from June 20, and October10, 2000, CDC Working Group onWaterborne CryptosporidiosisTeleconference. October 10, 2000.

Chappell, C., Okhuysen, P., Sterling, C.,Wang, C., Jakubowski, W., and Dupont,H. 1999. Infectivity of CryptosporidiumParvum in Healthy Adults with Pre-existing Anti-C. Parvum SerumImmunoglobulin G. Am. J. Trop. Med.Hyg. (60:1:157–164).

Cleasby, J. 1990. Filtration, Chapter 8, IN: (F.Pontius, ed) Water Quality andTreatment. AWWA, Denver, 57pp.

Collins, M., Dwyer, P., Margolin, A., andHogan, S. 1996. Assessment of MS2Bacteriphage Virus Giardia Cyst andCryptosporidium Oocyst Removal byHollow Fiber Ultrafiltration(Polysulfone) Membranes. ProceedingsAWWA Membrane Conference, Reno,NV 1996.

Cordell, R., Thor, P., Addiss, D., Theurer, J.,Lichterman, R., Ziliak, S., Juranek, D.,and Davis, J. 1997. Impact of a massivewaterborne cryptosporidiosis outbreakon child care facilities in metropolitanMilwaukee, Wisconsin. Pediatr Infect DisJ. (16:639–44).

Craun, Gunther. 1998. Memorandum from G.Craun to U. S. Environmental ProtectionAgency (M. Negro), dated 10/26/98.Waterborne outbreak data 1971–1996,community and noncommunity watersystems.

Drozd, C., and Schartzbrod, J. 1997.‘‘Removal of Cryptosporidium from RiverWater by Crossflow Microfiltration: APilot Scale Study,’’ Water Science andTechnology. (35:11–12:391–395).

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Dupont, H., Chappell, C., Sterling, C.,Okhuysen, P., Rose, J., and Jakubowski,W. 1995. The Infectivity ofCryptosporidium parvum in HealthyVolunteers. N. Engl. J. Med. (332:13:855–859).

Fayer, R. and Ungar, B. 1986.Cryptosporidium spp. andcryptosporidiosis. Microbial Review.(50:4:458–483).

Fayer, R., and T. Nerad. 1996. Effects of lowtemperatures on viability ofCryptosporidium parvum oocysts. Appl.Environ. Microbiol. 62:1431–1433.

Foundation for Water Research. 1994.Removal of Cryptosporidium oocysts bywater treatment processes. Foundationfor Water Research, Britain. April.

Frost, F., Craun, G., Calderon, R., and Hubbs,S. 1997. So many oocysts, so fewoutbreaks. J. AWWA (89:12:8–10).

Gerba, C.P., J.B. Rose and C.N. Haas (1996).Sensitive populations: who is at thegreatest risk? International Journal ofFood Microbiology: 30(1–2), 10pp.

Goodrich, J., Sylvana, Y., and Lykins, B.1995. Cost and Performance Evaluationsof Alternative Filtration Technologies forSmall Communities. ProceedingsAWWA Annual Conference.

Great Lakes Instruments. 1992. AnalyticalMethod for Turbidity Measurement: GLIMethod 2. GLI, Milwaukee, WI. 8 pp.

Hall, T., and Croll, B. 1996. The UKApproach to Cryptosporidium Control inWater Treatment. Proceedings AWWAWater Quality and TechnologyConference, 14pp.

Hancock, C., Rose, J., and Callahan, M. 1998.Crypto and Giardia in U.S. groundwater.J. AWWA (90:3:58–61).

Harrington W., Krupnick, A.J., and W.O.Spofford. 1985. ‘‘The Benefits ofPreventing an Outbreak of Giardiasis Dueto Drinking Water Contamination.’’ EPA/Resources for the Future Report.

Hirata, T., and Hashimoto, A. 1998.‘‘Experimental Assessment of theEfficacy of Microfiltration andUltrafiltration for CryptosporidiumRemoval,’’ Water Science andTechnology. (38:12:103–107).

Hoxie, N., Davis, J., Vergeront, J., Nashold, R.,and Blair, K. 1997. Cryptosporidiosis-associated mortality following a massivewaterborne outbreak in Milwaukee,Wisconsin. Amer. J. Publ. Health(87:12:2032–2035).

Jacangelo, J., Adham, S., and Laine, J. 1995.Mechanism of Cryptosporidium, Giardia,and MS2 virus removal by MF and UF.J. AWWA (87:9:107–121).

Juranek, D. 1995. Cryptosporidiosis: Sourcesof Infection and Guidelines forPrevention. Clinical Infectious Diseases:21 (1). See also www.cdc.gov/ncidod/dpd/sources.html

Kelley, M., Warrier, P., Brokaw, J., Barrett, K.and Komisar, S. 1995. A Study of TwoU.S. Army Installation Drinking WaterSources and Treatment Systems for theRemoval of Giardia andCryptosporidium. Proceedings AWWAAnnual Conference.

LeChevallier, M., Norton, W., and Lee, R.1991. Giardia and Cryptosporidium spp.

in filtered drinking water supplies. Appl.Environ. Microbial. (57:9:2617–2621).

LeChevallier, M., and Norton, W. 1992.Examining relationships betweenparticle counts and Giardia,Cryptosporidium and turbidity. J.AWWA (84:120:54–60).

LeChevallier, M., and Norton, W. 1995.Giardia and Cryptosporidium in raw andfinished water. J. AWWA (87:9:54–68).

Lykins, B., Adams, J., Goodrich, J., and Clark,R., Meeting Federal Regulations withMF/UF—EPA Ongoing Projects.Microfiltration II Conference, November12–13, 1994, San Diego, CA.

MacKenzie, W.R., N.J. Hoxie, M.E. Proctor,M.S. Gradus, K.A. Blair, D.E. Peterson,J.J. Kazmierczak, D.G. Addiss, K.R. Fox,J.B. Rose, and J.P. Davis. 1994. A massiveoutbreak in Milwaukee ofCryptosporidium infection transmittedthrough the public water supply. NewEngland Jour. Med. 331(3):161–167.

McTigue, N., LeChevallier, M., Arora, H., andClancy, J. 1998. National Assessment ofParticle Removal by Filtration.AWWARF. Denver, 256pp.

NDWAC, 2000. National Drinking WaterAdvisory Council Meeting Minutes andRecommendations, June 14, 2000.

Nieminski, E., and Ongerth, J. 1995.Removing Giardia and Cryptosporidiumby Conventional Treatment and DirectFiltration. J. AWWA (87:9:96–106).

Ongerth, J., and Pecoraro, J. 1995. RemovingCryptosporidium Using MultimediaFilters. J. AWWA. (87:12:83–89).

Ongerth, J., and Hutton, P. 1997. DEFiltration to Remove Cryptosporidium.JAWWA. December. pp. 39–46.

Patania, N., Jacangelo, J., Cummings, L.,Wilczak, A., Riley, K., and Oppenheimer,J. 1995. Optimization of Filtration forCyst Removal. AWWARF. Denver,178pp.

Rose, J.B., 1988, ‘‘Occurrence andSignificance of Cryptosporidium inwater, J. AWWA 80(2):53–58.

Schuler, P., and Gosh, M. 1990.Diatomaceous Earth Filtration of Cystsand Other Particulates Using ChemicalAdditives. Journal AWWA (Dec 1990).82(12):67–75.

Schuler, P., and Gosh, M. 1991. Slow SandFiltration of Cysts and OtherParticulates. AWWA Annual ConferenceProceedings. June. Pp 235–252.

Timms, S., Slade, J. and Fricker, C. 1995.Removal of Cryptosporidium by SlowSand Filtration. Wat. Sci. Tech. Vol. 31.No. 5–6, pp. 81–84.

USEPA.1989. National Primary DrinkingWater Regulations: Filtration,Disinfection; Turbidity, Giardia lamblia,Viruses, Legionella, and HeterotrophicBacteria; Final Rule (SWTR). 54 FR27486, June 29, 1989.

USEPA.1991. Guidance Manual forcompliance with the filtration anddisinfection requirements for publicwater systems using surface watersources. Washington, D.C., 574pp. [Alsopublished by AWWA].

USEPA.1993. Methods for the Determinationof Inorganic Substances inEnvironmental Samples. Environmental

Monitoring Systems Laboratory.Cincinnati, OH 45268. August. 169pp.600/R–93–100.

USEPA.1997a. National Primary DrinkingWater Regulations: Interim EnhancedSurface Water Treatment Notice of DataAvailability. 62 FR 59486. EPA–815–Z–97–001.

USEPA.1997b. National Primary DrinkingWater Regulations: Disinfectants andDisinfection Byproducts; Notice of DataAvailability. 62 FR 59388. EPA–815–Z–97–002/USEPA.1998a. National PrimaryDrinking Water Regulations: InterimEnhanced Surface Water Treatment;Final Rule. 63 FR 69477, December 16,1998. EPA 815–Z–98–009.

USEPA.1998b. Cryptosporidium and GiardiaOccurrence Assessment for the InterimEnhanced Surface Water Treatment Rule.Prepared for the Office of Ground Waterand Drinking Water, Washington, DC byScience Applications InternationalCorporation, McLean, VA, 185pp.

USEPA.1998c. National Primary DrinkingWater Regulations: Disinfectants andDisinfection Byproducts; Final Rule. 63FR 69389, December 16, 1998.

USEPA.1998d. Addendum to the DrinkingWater Criteria Document for Giardia.Prepared for Office of Water, Office ofScience and Technology, U.S. EPA,Washington, D.C., by ARCTECH, Inc.,1999. Gunther F. Craun & Associates.271pp.

USEPA 1998e. Demographic Distribution ofSensitive Population Groups. FinalReport. Prepared by SRA Technologies,Inc., Falls Church, VA. Work AssignmentNo. B–11/22 (SRA 557–05/14: February24).

USEPA 1998f. National Primary DrinkingWater Regulation: Consumer ConfidenceReports; Final Rule. 63 FR 44511, August19, 1998.

USEPA 1998g. Revision of Existing Varianceand Exemption Regulations To ComplyWith Requirements of the Safe DrinkingWater Act. 63 FR 43833, August 14,1998.

USEPA 1998h. Announcement of theDrinking Water Contaminant CandidateList; Notice. 63 FR 10273, March 2, 1998.

USEPA.1998i. Revisions to State PrimacyRequirements to Implement SafeDrinking Water Act Amendments; FinalRule. 63 FR 23362.

USEPA.1998j. Guidance on Implementing theCapacity Development Provisions of theSafe Drinking Water Act Amendments of1996. EPA Document Number: 816–R–98–006.

USEPA.1998k. Final Report of the SBREFASmall Business Advocacy Review Panelon EPA’s Planned Proposed Rule: LongTerm 1 Enhanced Surface WaterTreatment Rule, 76pp.

USEPA.1998l. Response to CommentDocument for the Interim EnhancedSurface Water Treatment Rule.

USEPA.1999a. Meeting Summary: Long Term1 Enhanced Surface Water TreatmentRule (LT1ESWTR) and Filter BackwashRecycle Rule (FBR). Dallas, TX. March.11pp.

USEPA.1999b. Stakeholder MeetingSummary: Long Term 1 Enhanced

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Surface Water Treatment Rule and FilterBackwash Recycle Rule. Denver, CO.July. 67pp.

USEPA.2000a. Occurrence Assessment forthe Long Term 1 Enhanced SurfaceWater Treatment and Filter BackwashRecycle Rule, (EPA/815/R/00/019).

USEPA.2000b. National Primary DrinkingWater Regulations: Long Term 1Enhanced Surface Water Treatment andFilter Backwash Rule; Proposed Rule. 65FR 19046. April 10, 2000. (EPA/815/Z/00/01).

USEPA.2000c. Summary of the ProposedLong Term 1 Enhanced Surface WaterTreatment and Filter Backwash Rule.April, 14, 2000.

USEPA.2000d. Application of the MicrobialFramework to LT2ESWTR FACAOptions, M/DBP FACA Meeting, June 1,2000.

USEPA.2000e. Regulatory FlexibilityScreening Analysis for the Long Term 1Enhanced Surface Water Treatment Rule,September 26, 2000.

USEPA.2000f. Proposed Long Term 1Enhanced Surface Water Treatment andFilter Backwash Rule (LT1FBR) Issuesfor the National Drinking WaterAdvisory Council. April 20, 2000.

USEPA.2000g. Meeting Summary,Government Dialogue on EPA’sUpcoming Drinking Water Regulations,May 30, 2000.

USEPA.2000h. Representative List ofMeetings Attended where Presentationswere Made or where Materials wereHanded out (LT1ESWTR and FBRR).

USEPA.2000i. Response to CommentDocument for the Filter BackwashRecycle Rule.

USEPA.2000j. Estimated Per Capita WaterIngestion in the United States. Office ofScience and Technology. February, 2000.

USEPA.2000k. M/DBP FACA MeetingMaterials. June 1–2, 2000.

USEPA.2000l. SAB Commentary on EPA’sDraft Proposal for LT1ESWTR and FBRR.EPA–SAB–DWC–COM–00–004. May 23,2000.

USEPA.2001a. Economic Analysis for theLong Term 1 Enhanced Surface WaterTreatment Rule. EPA Document Number815–R–00–021. October 12, 2001.

USEPA.2001b. Response to CommentDocument for the Long Term 1 EnhancedSurface Water Treatment Rule. EPADocument Number EPA 815–R–01–026.

USEPA/SAB 1990. Reducing Risk: SettingPriorities and Strategies forEnvironmental Protection. U.S.Environmental Protection AgencyScience Advisory Board (A–101),Washington, D.C. Report No. SAB–EC–90–021 (September).

West, T., Danile, P., Meyerhofer, P., DeGraca,A., Leonard, S., and Gerba, C. 1994.Evaluation of Cryptosporidium Removalthrough High-rate Filtration. ProceedingsAWWA Annual Conference, June. Pp493–504.

List of Subjects

40 CFR Parts 9

Reporting and recordkeepingrequirements.

40 CFR Part 141Environmental protection, Chemicals,

Indians-lands, Intergovernmentalrelations, Radiation protection,Reporting and recordkeepingrequirements, Water supply.

40 CFR Part 142Environmental protection,

Administrative practice and procedure,Chemicals, Indians-lands, Radiationprotection, Reporting and recordkeepingrequirements, Water supply.

Dated: December 20, 2001.Christine Todd Whitman,Administrator.

For the reasons set forth in thepreamble, title 40 chapter I of the Codeof Federal Regulations is amended asfollows:

PART 9—[AMENDED]

1. The authority citation for part 9continues to read as follows:

Authority: 7 U.S.C. 135 et seq., 136–136y;15 U.S.C. 2001, 2003, 2005, 2006, 2601–2671;21 U.S.C. 331j, 346a, 348; 31 U.S.C. 9701; 33U.S.C. 1251 et seq., 1311, 1313d, 1314, 1318,1321, 1326, 1330, 1342, 1344, 1345 (d) and(e), 1361; Executive Order 11735, 38 FR21243, 3 CFR, 1971–1975 Comp. p. 973; 42U.S.C. 241, 242b, 243, 246, 300f, 300g, 300g–1, 300g–2, 300g–3, 300g–4, 300g–5, 300g–6,300j–1, 300j–2, 300j–3, 300j–4, 300j–9, 1857et seq., 6901–6992k, 7401–7671q, 7542,9601–9657, 11023, 11048.

2. In § 9.1 the table is amended byadding under the indicated heading:

a. By adding entries 141.530–141.536,141.540–141.544, 141.550–141.553,141.560–141.564 and 141.570–141.571in numerical order.

b. By removing the entry 142.14(a)–(d)(7) and adding in its place a newentry § 142.14(b)–(d)(7).

c. By adding a new entry for 142.14(a)in numerical order.

d. By adding new entries for 142.16(g)and 142.16(j) in numerical order.

The additions read as follows:

§ 9.1 OMB approvals under the PaperworkReduction Act.* * * * *

40 CFR citation OMB controlNo.

* * * * *

National Primary Drinking WaterRegulations

* * * * *141.530–141.536 .................. 2040–0229141.540–141.544 .................. 2040–0229141.550–141.553 .................. 2040–0229141.560–141.564 .................. 2040–0229141.570–141.571 .................. 2040–0229

40 CFR citation OMB controlNo.

National Primary Drinking WaterRegulations Implementation

* * * * *142.14(a) .............................. 2040–0229

2040–0090142.14(b)–(d)(7) .................... 2040–0090

* * * * *142.16(g) .............................. 2040–0229142.16(j) ................................ 2040–0229

* * * * *

PART 141—NATIONAL PRIMARYDRINKING WATER REGULATIONS

3. The authority citation for part 141continues to read as follows:

Authority: 42 U.S.C. 300f, 300g–1, 300g–2,300g–3, 300g–4, 300g–5, 300g–6, 300j–4,300j–9, and 300j–11.

4. Section 141.2 is amended byrevising the definitions of‘‘Comprehensive performanceevaluation’’ (CPE), ‘‘Ground water underthe direct influence of surface water’’and ‘‘Disinfection profile’’ to read asfollows:

§ 141.2 Definitions.

* * * * *Comprehensive performance

evaluation (CPE) is a thorough reviewand analysis of a treatment plant’sperformance-based capabilities andassociated administrative, operation andmaintenance practices. It is conductedto identify factors that may be adverselyimpacting a plant’s capability to achievecompliance and emphasizes approachesthat can be implemented withoutsignificant capital improvements. Forpurpose of compliance with subparts Pand T of this part, the comprehensiveperformance evaluation must consist ofat least the following components:Assessment of plant performance;evaluation of major unit processes;identification and prioritization ofperformance limiting factors;assessment of the applicability ofcomprehensive technical assistance; andpreparation of a CPE report.* * * * *

Disinfection profile is a summary ofGiardia lamblia inactivation through thetreatment plant. The procedure fordeveloping a disinfection profile iscontained in § 141.172 (Disinfectionprofiling and benchmarking) in subpartP and §§ 141.530–141.536 (Disinfectionprofile) in subpart T of this part.* * * * *

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Ground water under the directinfluence of surface water (GWUDI)means any water beneath the surface ofthe ground with significant occurrenceof insects or other macroorganisms,algae, or large-diameter pathogens suchas Giardia lamblia or Cryptosporidium,or significant and relatively rapid shiftsin water characteristics such asturbidity, temperature, conductivity, orpH which closely correlate toclimatological or surface waterconditions. Direct influence must bedetermined for individual sources inaccordance with criteria established bythe State. The State determination ofdirect influence may be based on site-specific measurements of water qualityand/or documentation of wellconstruction characteristics and geologywith field evaluation.* * * * *

5. Section 141.70 is amended byadding paragraph (e) to read as follows:

§ 141.70 General requirements.* * * * *

(e) Additional requirements forsystems serving fewer than 10,000people. In addition to complying withrequirements in this subpart, systemsserving fewer than 10,000 people mustalso comply with the requirements insubpart T of this part.

6. Section 141.73 is amended byadding paragraph (a)(4) and revisingparagraph (d) to read as follows:

§ 141.73 Filtration.* * * * *

(a) * * *(4) Beginning January 14, 2005,

systems serving fewer than 10,000

people must meet the turbidityrequirements in §§ 141.550 through141.553.* * * * *

(d) Other filtration technologies. Apublic water system may use a filtrationtechnology not listed in paragraphs (a)through (c) of this section if itdemonstrates to the State, using pilotplant studies or other means, that thealternative filtration technology, incombination with disinfection treatmentthat meets the requirements of§ 141.72(b), consistently achieves 99.9percent removal and/or inactivation ofGiardia lamblia cysts and 99.99 percentremoval and/or inactivation of viruses.For a system that makes thisdemonstration, the requirements ofparagraph (b) of this section apply.Beginning January 1, 2002, systemsserving at least 10,000 people must meetthe requirements for other filtrationtechnologies in § 141.173(b). BeginningJanuary 14, 2005, systems serving fewerthan 10,000 people must meet therequirements for other filtrationtechnologies in § 141.550 through141.553.

7. Section 141.153 is amended byrevising the first sentence of paragraph(d)(4)(v)(C) to read as follows:

§ 141.153 Content of the reports.* * * * *

(d) * * *(4) * * *(v) * * *(C) When it is reported pursuant to

§ 141.73 or § 141.173 or § 141.551: thehighest single measurement and thelowest monthly percentage of samplesmeeting the turbidity limits specified in

§ 141.73 or § 141.173, or § 141.551 forthe filtration technology being used.* * ** * * * *

8. The heading to Subpart P is revisedto read as follows:

Subpart P—Enhanced Filtration andDisinfection—Systems Serving 10,000or More People

* * * * *

9. Section 141.170 is amended byadding paragraph (d) to read as follows:

§ 141.170 General requirements.

* * * * *(d) Subpart H systems that did not

conduct optional monitoring under§ 141.172 because they served fewerthan 10,000 persons when suchmonitoring was required, but serve morethan 10,000 persons prior to January 14,2005 must comply with §§ 141.170,141.171, 141.173, 141.174, and 141.175.These systems must also consult withthe State to establish a disinfectionbenchmark. A system that decides tomake a significant change to itsdisinfection practice, as described in§ 141.172(c)(1)(i) through (iv) mustconsult with the State prior to makingsuch change.

10. Section 141.202 is amended inTable 1 by revising entry 6 to read asfollows:

§ 141.202 Tier 1 Public Notice—Form,manner, and frequency of notice.

* * * * *(a) * * *

TABLE 1 TO SEC. 141.202.—VIOLATION CATEGORIES AND OTHER SITUATIONS REQUIRING A TIER 1 PUBLIC NOTICE

* * * * * * *(6) Violation of the Surface Water Treatment Rule (SWTR), Interim Enhanced Surface Water Treatment Rule (IESWTR) or Long Term 1 En-

hanced Surface Water Treatment Rule (LT1ESWTR) treatment technique requirement resulting from a single exceedance of the maximum al-lowable turbidity limit (as identified in Appendix A), where the primacy agency determines after consultation that a Tier 1 notice is required orwhere consultation does not take place within 24 hours after the system learns of the violation;

* * * * * * *

* * * * *11. Section 141.203 is amended by

revising paragraph (b)(3)(ii) to read asfollows:

§ 141.203 Tier 2 Public Notice—Form,manner, and frequency of notice.

* * * * *(b) * * *

(3) * * *(ii) Violation of the SWTR, IESWTR or

LT1ESWTR treatment techniquerequirement resulting from a singleexceedance of the maximum allowableturbidity limit.* * * * *

12. Appendix A to subpart Q isamended:

a. Under I.A. by revising entry 5.b. Under I.A. by revising entry 7.c. Adding a new entry 9.d. Under I.G. by revising entry 10.e. Revising endnote 6.The additions and revisions read as

follows:

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APPENDIX A TO SUBPART Q OF PART 141.—NPDWR VIOLATIONS AND OTHER SITUATIONS REQUIRING PUBLIC NOTICE 1

Contaminant

MCL/MRDL/TT violations 2 Monitoring & testing procedure violations

Tier of pub-lic notice re-

quiredCitation

Tier of pub-lic notice re-

quiredCitation

I. Violations of National Primary DrinkingWater Regulations (NPDWR): 3

* * * * * * *A. Microbiological Contaminants

* * * * * * *5. Turbidity (for TT violations resulting

from a single exceedance of max-imum allowable turbidity level).

6 2,1 141.71(a)(2),141.71(c)(2)(i),141.73(a)(2), 141.73 (b)(2),141.73 (c)(2), 141.73(d),141.173(a)(2), 141.173(b),141.551(b).

3 141.74(a)(1), 141.74(b)(2),141.74(c)(1), 141.174,141.560(a)–(c), 141.561.

* * * * * * *7. Interim Enhanced Surface Water

Treatment Rule violations, other thanviolations resulting from single ex-ceedance of max. turbidity level (TT).

7 2 141.170–141.173, 141.500–141.553.

3 141.172, 141.174, 141.530–141.544, 141.560–141.564.

* * * * * * *9. Long Term 1 Enhanced Surface

Water Treatment Rule violations.2 141.500–141.553 ........................ 3 141.530–141.544, 141.560–

141.564.

* * * * * * *G. Disinfection Byproducts (DBPs), Byprod-

uct Precursors, Disinfectant Residuals.Where disinfection is used in the treatmentof drinking water, disinfectants combinewith organic and inorganic matter presentin water to form chemicals called disinfec-tion byproducts (DBPs). EPA sets stand-ards for controlling the levels of disinfect-ants and DBPs in drinking water, includingtrihalomethanes (THMs) and haloaceticacids (HAAs).9

* * * * * * *10. Bench marking and disinfection

profiling.N/A N/A .............................................. 3 141.172 141.530–141.544.

* * * * * * *

Appendix A–Endnotes:1 Violations and other situations not listed in this table (e.g., reporting violations and failure to prepare Consumer Confidence Reports), do not

require notice, unless otherwise determined by the primacy agency. Primacy agencies may, at their option, also require a more stringent publicnotice tier (e.g., Tier 1 instead of Tier 2 or Tier 2 instead of Tier 3) for specific violations and situations listed in this Appendix, as authorizedunder § 141.202(a) and § 141.203(a).

2 MCL—Maximum contaminant level, MRDL—Maximum residual disinfectant level, TT—Treatment technique3 The term Violations of National Primary Drinking Water Regulations (NPDWR) is used here to include violations of MCL, MRDL, treatment

technique, monitoring, and testing procedure requirements.* * * * * * *6 Systems with treatment technique violations involving a single exceedance of a maximum turbidity limit under the Surface Water Treatment

Rule (SWTR), the Interim Enhanced Surface Water Treatment Rule (IESWTR), or the Long Term 1 Enhanced Surface Water Treatment Rule(LT1ESWTR) are required to consult with the primacy agency within 24 hours after learning of the violation. Based on this consultation, the pri-macy agency may subsequently decide to elevate the violation to Tier 1. If a system is unable to make contact with the primacy agency in the24-hour period, the violation is automatically elevated to Tier 1.

7 Most of the requirements of the Interim Enhanced Surface Water Treatment Rule (63 FR 69477) (§§ 141.170—141.171, 141.173—141.174)become effective January 1, 2002 for the Subpart H systems (surface water systems and ground water systems under the direct influence of sur-face water) serving at least 10,000 persons. However, § 141.172 has some requirements that become effective as early as April 16, 1999. TheSurface Water Treatment Rule remains in effect for systems serving at least 10,000 persons even after 2002; the Interim Enhanced SurfaceWater Treatment Rule adds additional requirements and does not in many cases supercede the SWTR.

* * * * * * *9 Subpart H community and non-transient non-community systems serving ≥10,000 must comply with new DBP MCLs, disinfectant MRDLs,

and related monitoring requirements beginning January 1, 2002. All other community and non-transient non-community systems must meet theMCLs and MRDLs beginning January 1, 2004. Subpart H transient non-community systems serving 10,000 or more persons and using chlorinedioxide as a disinfectant or oxidant must comply with the chlorine dioxide MRDL begining January 1, 2002. Subpart H transient non-communitysystems serving fewer than 10,000 persons and using only ground water not under the direct influence of surface water and using chlorine diox-ide as a disinfectant or oxidant must comply with the chlorine dioxide MRDL beginning January 1, 2004.

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Appendix B—[Amended]

13. Appendix B to subpart Q isamended by:

a. Revising entry A.2c.b. Revising heading B.c. Revising entries B.3., B.4, B.5, B.6.,

and B.7.

d. Revising endnotes 4, 6 and 10.e. Revising endnote 8.The revisions read as follows:

APPENDIX B TO SUBPART Q OF PART 141.—STANDARD HEALTH EFFECTS LANGUAGE FOR PUBLIC NOTIFICATION

Contaminant MCLG 1, mg/L MCL 2 mg/L Standard health effects language for public notifi-cation

National Primary Drinking Water Regulations(NPDWR):

A. Microbiological Contaminants

* * * * * * *2c. Turbidity (IESWTR TT and LT1ESWTR

TT) 8.None .............................. TT Turbidity has no health effects. However, turbidity

can interfere with disinfection and provide amedium for microbial growth. Turbidity may in-dicate the presence of disease-causing orga-nisms. These organisms include bacteria, vi-ruses, and parasites that can cause symptomssuch as nausea, cramps, diarrhea and associ-ated headaches.

* * * * * * *B. Surface Water Treatment Rule (SWTR), Interim

Enhanced Surface Water Treatment Rule(IESWTR), Long Term 1 Enhanced SurfaceWater Treatment Rule (LT1ESWTR) and theFilter Backwash Recycling Rule (FBRR) viola-tions:

* * * * * * *3. Giardia lamblia ............................................(SWTR/IESWTR/LT1ESWTR)

Zero ............................... TT 10 Inadequately treated water may contain disease-causing organisms. These organisms includebacteria, viruses, and parasites which cancause symptoms such as nausea, cramps, diar-rhea, and associated headaches.

4. Viruses(SWTR/IESWTR/LT1ESWTR)5. Heterotrophic plate count (HPC) bacteria 9

(SWTR/IESWTR/LT1ESWTR)6. Legionella(SWTR/IESWTR/LT1ESWTR)7. Cryptosporidium(IESWTR/FBRR/LT1ESWTR)

* * * * * * *1 MCLG—Maximum contaminant level goal.2 MCL—Maximum contaminant level.4 There are various regulations that set turbidity standards for different types of systems, including 40 CFR 141.13, and the 1989 Surface

Water Treatment Rule, the 1998 Interim Enhanced Surface Water Treatment Rule and the 2001 Long Term 1 Enhanced Surface Water Treat-ment Rule. The MCL for the montly turbidity average is 1 NTU; the MCL for the 2-day average is 5 NTU for systems that are required to filter buthave not yet installed filtration (40 CFR 141.13).

6 There are various regulations that set turbidity standards for different types of systems, including 40 CFR 141.13, and the 1989 SurfaceWater Treatment Rule, the 1998 Interim Enhanced Surface Water Treatment Rule and the 2001 Long Term 1 Enhanced Surface Water Treat-ment Rule. Systems subject to the Surface Water Treatment Rule (both filtered and unfiltered) may not exceed 5 NTU. In addition, in filtered sys-tems, 95 percent of samples each month must not exceed 0.5 NTU in systems using conventional or direct filtration and must not exceed 1 NTUin systems using slow sand or diatomaceous earth filtration or other filtration technologies approved by the primacy agency.

8 There are various regulations that set turbidity standards for different types of systems, including 40 CFR 141.13, the 1989 Surface WaterTreatment Rule (SWTR), the 1998 Interim Enhanced Surface Water Treatment Rule (IESWTR) and the 2001 Long Term 1 Enhanced SurfaceWater Treatment Rule (LT1ESWTR). For systems subject to the IESWTR (systems serving at least 10,000 people, using surface water orground water under the direct influence of surface water), that use conventional filtration or direct filtration, after January 1, 2002, the turbiditylevel of a system’s combined filter effluent may not exceed 0.3 NTU in at least 95 percent of monthly measurements, and the turbidity level of asystem’s combined filter effluent must not exceed 1 NTU at any time. Systems subject to the IESWTR using technologies other than conven-tional, direct, slow sand, or diatomaceous earth filtration must meet turbidity limits set by the primacy agency. For systems subject to theLT1ESWTR (systems serving fewer than 10,000 people, using surface water or ground water under the direct influence of surface water) thatuse conventional filtration or direct filtration, after January 14, 2005 the turbidity level of a system’s combined filter effluent may not exceed 0.3NTU in at least 95 percent of monthly measurements, and the turbidity level of a system’s combined filter effluent must not exceed 1 NTU at anytime. Systems subject to the LT1ESWTR using technologies other than conventional, direct, slow sand, or diatomaceous earth filtration mustmeet turbidity limits set by the primacy agency.

9 The bacteria detected by heterotrophic plate count (HPC) are not necessarily harmful. HPC is simply an alternative method of determiningdisinfectant residual levels. The number of such bacteria is an indicator of whether there is enough disinfectant in the distribution system.

10 SWTR, IESWTR, and LT1ESWTR treatment technique violations that involve turbidity exceedances may use the health effects language forturbidity instead.

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14. Part 141 is amended by adding anew subpart T to read as follows:

Subpart T—Enhanced Filtration andDisinfection—Systems Serving Fewer Than10,000 People

General Requirements141.500 General requirements141.501 Who is subject to the requirements

of subpart T?141.502 When must my system comply

with these requirements?141.503 What does subpart T require?

Finished Water Reservoirs141.510 Is my system subject to the new

finished water reservoir requirements?141.511 What is required of new finished

water reservoirs?

Additional Watershed Control Requirementsfor Unfiltered Systems141.520 Is my system subject to the updated

watershed control requirements?141.521 What updated watershed control

requirements must my unfiltered systemimplement to continue to avoidfiltration?

141.522 How does the State determinewhether my system’s watershed controlrequirements are adequate?

Disinfection Profile141.530 What is a Disinfection Profile and

who must develop one?141.531 What criteria must a State use to

determine that a profile is unnecessary?141.532 How does my system develop a

Disinfection Profile and when must itbegin?

141.533 What data must my system collectto calculate a Disinfection Profile?

141.534 How does my system use this datato calculate an inactivation ratio?

141.535 What if my system useschloramines, ozone, or chlorine dioxidefor primary disinfection?

141.536 My system has developed aninactivation ratio; what must we donow?

Disinfection Benchmark141.540 Who has to develop a Disinfection

Benchmark?141.541 What are significant changes to

disinfection practice?141.542 What must my system do if we are

considering a significant change todisinfection practices?

141.543 How is the Disinfection Benchmarkcalculated?

141.544 What if my system useschloramines, ozone, or chlorine dioxidefor primary disinfection?

Combined Filter Effluent Requirements141.550 Is my system required to meet

subpart T combined filter effluentturbidity limits?

141.551 What strengthened combined filtereffluent turbidity limits must my systemmeet?

141.552 My system consists of ‘‘alternativefiltration’’ and is required to conduct ademonstration. What is required of mysystem and how does the State establishmy turbidity limits?

141.553 My system practices limesoftening—is there any special provisionregarding my combined filter effluent?

Individual Filter Turbidity Requirements141.560 Is my system subject to individual

filter turbidity requirements?141.561 What happens if my system’s

turbidity monitoring equipment fails?141.562 My system only has two or fewer

filters—is there any special provisionregarding individual filter turbiditymonitoring?

141.563 What follow-up action is mysystem required to take based oncontinuous turbidity monitoring?

141.564 My system practices limesoftening—is there any special provisionregarding my individual filter turbiditymonitoring?

Reporting and Recordkeeping Requirements141.570 What does subpart T require that

my system report to the State?141.571 What records does subpart T

require my system to keep?

Subpart T—Enhanced Filtration andDisinfection—Systems Serving FewerThan 10,000 People

General Requirements

§ 141.500 General requirements.The requirements of this subpart

constitute national primary drinkingwater regulations. These regulationsestablish requirements for filtration anddisinfection that are in addition tocriteria under which filtration anddisinfection are required under subpartH of this part. The regulations in thissubpart establish or extend treatmenttechnique requirements in lieu ofmaximum contaminant levels for thefollowing contaminants: Giardialamblia, viruses, heterotrophic platecount bacteria, Legionella,Cryptosporidium and turbidity. Thetreatment technique requirementsconsist of installing and properlyoperating water treatment processeswhich reliably achieve:

(a) At least 99 percent (2 log) removalof Cryptosporidium between a pointwhere the raw water is not subject torecontamination by surface water runoffand a point downstream before or at thefirst customer for filtered systems, orCryptosporidium control under thewatershed control plan for unfilteredsystems; and

(b) Compliance with the profiling andbenchmark requirements in §§ 141.530through 141.544.

§ 141.501 Who is subject to therequirements of subpart T?

You are subject to these requirementsif your system:

(a) Is a public water system;(b) Uses surface water or GWUDI as a

source; and

(c) Serves fewer than 10,000 persons.

§ 141.502 When must my system complywith these requirements?

You must comply with theserequirements in this subpart beginningJanuary 14, 2005 except whereotherwise noted.

§ 141.503 What does subpart T require?There are seven requirements of this

subpart, and you must comply with allrequirements that are applicable to yoursystem. These requirements are:

(a) You must cover any finished waterreservoir that you began to construct onor after March 15, 2002 as described in§§ 141.510 and 141.511;

(b) If your system is an unfilteredsystem, you must comply with theupdated watershed control requirementsdescribed in §§ 141.520–141.522;

(c) If your system is a community ornon-transient non-community watersystems you must develop a disinfectionprofile as described in §§ 141.530–141.536;

(d) If your system is consideringmaking a significant change to itsdisinfection practices, you must developa disinfection benchmark and consultwith the State for approval of the changeas described in §§ 141.540–141.544;

(e) If your system is a filtered system,you must comply with the combinedfilter effluent requirements as describedin §§ 141.550–141.553;

(f) If your system is a filtered systemthat uses conventional or directfiltration, you must comply with theindividual filter turbidity requirementsas described in §§ 141.560–141.564; and

(g) You must comply with theapplicable reporting and recordkeepingrequirements as described in §§ 141.570and 141.571.

Finished Water Reservoirs

§ 141.510 Is my system subject to the newfinished water reservoir requirements?

All subpart H systems which servefewer than 10,000 are subject to thisrequirement.

§ 141.511 What is required of new finishedwater reservoirs?

If your system begins construction ofa finished water reservoir on or afterMarch 15, 2002 the reservoir must becovered. Finished water reservoirs forwhich your system began constructionprior to March 15, 2002 are not subjectto this requirement.

Additional Watershed ControlRequirements for Unfiltered Systems

§ 141.520 Is my system subject to theupdated watershed control requirements?

If you are a subpart H system servingfewer than 10,000 persons which does

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not provide filtration, you mustcontinue to comply with all of thefiltration avoidance criteria in § 141.71,as well as the additional watershedcontrol requirements in § 141.521.

§ 141.521 What updated watershed controlrequirements must my unfiltered systemimplement to continue to avoid filtration?

Your system must take any additionalsteps necessary to minimize thepotential for contamination byCryptosporidium oocysts in the sourcewater. Your system’s watershed controlprogram must, for Cryptosporidium:

(a) Identify watershed characteristicsand activities which may have anadverse effect on source water quality;and

(b) Monitor the occurrence ofactivities which may have an adverseeffect on source water quality.

§ 141.522 How does the State determinewhether my system’s watershed controlrequirements are adequate?

During an onsite inspectionconducted under the provisions of§ 141.71(b)(3), the State must determinewhether your watershed controlprogram is adequate to limit potentialcontamination by Cryptosporidiumoocysts. The adequacy of the programmust be based on thecomprehensiveness of the watershedreview; the effectiveness of yourprogram to monitor and controldetrimental activities occurring in thewatershed; and the extent to which yoursystem has maximized land ownershipand/or controlled land use within thewatershed.

Disinfection Profile

§ 141.530 What is a Disinfection Profileand who must develop one?

A disinfection profile is a graphicalrepresentation of your system’s level ofGiardia lamblia or virus inactivationmeasured during the course of a year. Ifyou are a subpart H community or non-transient non-community water systemswhich serves fewer than 10,000 persons,your system must develop a disinfectionprofile unless your State determines thatyour system’s profile is unnecessary.Your State may approve the use of amore representative data set fordisinfection profiling than the data setrequired under §§ 141.532–141.536.

§ 141.531 What criteria must a State use todetermine that a profile is unnecessary?

States may only determine that asystem’s profile is unnecessary if asystem’s TTHM and HAA5 levels arebelow 0.064 mg/L and 0.048 mg/L,respectively. To determine these levels,TTHM and HAA5 samples must becollected after January 1, 1998, duringthe month with the warmest watertemperature, and at the point ofmaximum residence time in yourdistribution system.

§ 141.532 How does my system develop aDisinfection Profile and when must itbegin?

A disinfection profile consists of threesteps:

(a) First, your system must collectdata for several parameters from theplant as discussed in § 141.533 over thecourse of 12 months. If your systemserves between 500 and 9,999 personsyou must begin to collect data no later

than July 1, 2003. If your system servesfewer than 500 persons you must beginto collect data no later than January 1,2004.

(b) Second, your system must use thisdata to calculate weekly log inactivationas discussed in §§ 141.534 and 141.535;and

(c) Third, your system must use theseweekly log inactivations to develop adisinfection profile as specified in§ 141.536.

§ 141.533 What data must my systemcollect to calculate a Disinfection Profile?

Your system must monitor thefollowing parameters to determine thetotal log inactivation using theanalytical methods in § 141.74 (a), onceper week on the same calendar day, over12 consecutive months:

(a) The temperature of the disinfectedwater at each residual disinfectantconcentration sampling point duringpeak hourly flow;

(b) If your system uses chlorine, thepH of the disinfected water at eachresidual disinfectant concentrationsampling point during peak hourly flow;

(c) The disinfectant contact time(s)(‘‘T’’) during peak hourly flow; and

(d) The residual disinfectantconcentration(s) (‘‘C’’) of the waterbefore or at the first customer and priorto each additional point of disinfectionduring peak hourly flow.

§ 141.534 How does my system use thisdata to calculate an inactivation ratio?

Calculate the total inactivation ratioas follows, and multiply the value by3.0 to determine log inactivation ofGiardia lamblia:

If your system * * * Your system must determine * * *

(a) Uses only one point of disinfect-ant application.

(1) One inactivation ratio (CTcalc/CT99.9) before or at the first customer during peak hourly flowor

(2) Successive CTcalc/CT99.9 values, representing sequential inactivation ratios, between the point of dis-infectant application and a point before or at the first customer during peak hourly flow. Under this alter-native, your system must calculate the total inactivation ratio by determining (CTcalc/CT99.9) for each se-quence and then adding the (CTcalc/CT99.9) values together to determine (3CTcalc/CT99.9).

(b) Uses more than one point ofdisinfectant application before thefirst customer.

The (CTcalc/CT99.9) value of each disinfection segment immediately prior to the next point of disinfectantapplication, or for the final segment, before or at the first customer, during peak hourly flow using theprocedure specified in paragraph (a)(2) of this section.

§ 141.535 What if my system useschloramines, ozone, or chlorine dioxide forprimary disinfection?

If your system uses chloramines,ozone, or chlorine dioxide for primarydisinfection, you must also calculate thelogs of inactivation for viruses anddevelop an additional disinfectionprofile for viruses using methodsapproved by the State.

§ 141.536 My system has developed aninactivation ratio; what must we do now?

Each log inactivation serves as a datapoint in your disinfection profile. Yoursystem will have obtained 52measurements (one for every week ofthe year). This will allow your systemand the State the opportunity toevaluate how microbial inactivationvaried over the course of the year bylooking at all 52 measurements (yourDisinfection Profile). Your system mustretain the Disinfection Profile data in

graphic form, such as a spreadsheet,which must be available for review bythe State as part of a sanitary survey.Your system must use this data tocalculate a benchmark if you areconsidering changes to disinfectionpractices.

Disinfection Benchmark

§ 141.540 Who has to develop aDisinfection Benchmark?

If you are a subpart H system requiredto develop a disinfection profile under

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§§ 141.530 through 141.536, yoursystem must develop a DisinfectionBenchmark if you decide to make asignificant change to your disinfectionpractice. Your system must consult withthe State for approval before you canimplement a significant disinfectionpractice change.

§ 141.541 What are significant changes todisinfection practice?

Significant changes to disinfectionpractice include:

(a) Changes to the point ofdisinfection;

(b) Changes to the disinfectant(s) usedin the treatment plant;

(c) Changes to the disinfectionprocess; or

(d) Any other modification identifiedby the State.

§ 141.542 What must my system do if weare considering a significant change todisinfection practices?

If your system is considering asignificant change to its disinfectionpractice, your system must calculate adisinfection benchmark(s) as describedin §§ 141.543 and 141.544 and providethe benchmark(s) to your State. Yoursystem may only make a significantdisinfection practice change afterconsulting with the State for approval.Your system must submit the followinginformation to the State as part of theconsultation and approval process:

(a) A description of the proposedchange;

(b) The disinfection profile for Giardialamblia (and, if necessary, viruses) anddisinfection benchmark;

(c) An analysis of how the proposedchange will affect the current levels ofdisinfection; and

(d) Any additional informationrequested by the State.

§ 141.543 How is the DisinfectionBenchmark calculated?

If your system is making a significantchange to its disinfection practice, itmust calculate a disinfection benchmarkusing the procedure specified in thefollowing table.

To calculate a disinfection benchmark your system must perform the following steps

Step 1: Using the data your system collected to develop the Disinfection Profile, determine the average Giardia lamblia inactivation for each cal-endar month by dividing the sum of all Giardia lamblia inactivations for that month by the number of values calculated for that month.

Step 2: Determine the lowest monthly average value out of the twelve values. This value becomes the disinfection benchmark.

§ 141.544 What if my system useschloramines, ozone, or chlorine dioxide forprimary disinfection?

If your system uses chloramines,ozone or chlorine dioxide for primarydisinfection your system must calculatethe disinfection benchmark from thedata your system collected for viruses todevelop the disinfection profile inaddition to the Giardia lambliadisinfection benchmark calculatedunder § 141.543. This viral benchmarkmust be calculated in the same mannerused to calculate the Giardia lambliadisinfection benchmark in § 141.543.

Combined Filter Effluent Requirements

§ 141.550 Is my system required to meetsubpart T combined filter effluent turbiditylimits?

All subpart H systems which servepopulations fewer than 10,000, arerequired to filter, and utilize filtrationother than slow sand filtration ordiatomaceous earth filtration must meetthe combined filter effluent turbidityrequirements of §§ 141.551–141.553 . Ifyour system uses slow sand ordiatomaceous earth filtration you arenot required to meet the combined filtereffluent turbidity limits of subpart T,but you must continue to meet thecombined filter effluent turbidity limitsin § 141.73.

§ 141.551 What strengthened combinedfilter effluent turbidity limits must mysystem meet?

Your system must meet twostrengthened combined filter effluentturbidity limits.

(a) The first combined filter effluentturbidity limit is a ‘‘95th percentile’’turbidity limit that your system mustmeet in at least 95 percent of theturbidity measurements taken eachmonth. Measurements must continue tobe taken as described in § 141.74(a) and(c). Monthly reporting must becompleted according to § 141.570. Thefollowing table describes the requiredlimits for specific filtrationtechnologies.

If your system consists of * * * Your 95th percentile turbidity value is * * *

(1) Conventional Filtration or Direct Filtration ................................................................................. 0.3 NTU.(2) All other ‘‘Alternative’’ Filtration ................................................................................................. A value determined by the State (no to exceed

1 NTU) based on the demonstration de-scribed in § 141.552.

(b) The second combined filtereffluent turbidity limit is a ‘‘maximum’’turbidity limit which your system mayat no time exceed during the month.

Measurements must continue to betaken as described in § 141.74(a) and (c).Monthly reporting must be completedaccording to § 141.570. The following

table describes the required limits forspecific filtration technologies.

If your system consists of * * * Your maximum turbidity value is * * *

(1) Conventional Filtration or Direct Filtration ................................................................................. 1 NTU.(2) All other ‘‘Alternative’’ ................................................................................................................ A value determined by the State (not to ex-

ceed 5 NTU) based on the demonstration asdescribed in § 141.552.

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§ 141.552 My system consists of‘‘alternative filtration’’ and is required toconduct a demonstration—what is requiredof my system and how does the Stateestablish my turbidity limits?

(a) If your system consists ofalternative filtration(filtration other thanslow sand filtration, diatomaceous earthfiltration, conventional filtration, ordirect filtration) you are required toconduct a demonstration (see tables in§ 141.551). Your system mustdemonstrate to the State, using pilotplant studies or other means, that yoursystem’s filtration, in combination withdisinfection treatment, consistentlyachieves:

(1) 99 percent removal ofCryptosporidium oocysts;

(2) 99.9 percent removal and/orinactivation of Giardia lamblia cysts;and

(3) 99.99 percent removal and/orinactivation of viruses.

(b) [Reserved]

§ 141.553 My system practices limesoftening—is there any special provisionregarding my combined filter effluent?

If your system practices limesoftening, you may acidify

representative combined filter effluentturbidity samples prior to analysis usinga protocol approved by the State.

Individual Filter TurbidityRequirements

§ 141.560 Is my system subject toindividual filter turbidity requirements?

If your system is a subpart H systemserving fewer than 10,000 people andutilizing conventional filtration or directfiltration, you must conduct continuousmonitoring of turbidity for eachindividual filter at your system. Thefollowing requirements apply tocontinuous turbidity monitoring:

(a) Monitoring must be conductedusing an approved method in§ 141.74(a);

(b) Calibration of turbidimeters mustbe conducted using proceduresspecified by the manufacturer;

(c) Results of turbidity monitoringmust be recorded at least every 15minutes;

(d) Monthly reporting must becompleted according to § 141.570; and

(e) Records must be maintainedaccording to § 141.571.

§ 141.561 What happens if my system’sturbidity monitoring equipment fails?

If there is a failure in the continuousturbidity monitoring equipment, yoursystem must conduct grab samplingevery four hours in lieu of continuousmonitoring until the turbidimeter isback on-line. Your system has 14 daysto resume continuous monitoring beforea violation is incurred.

§ 141.562 My system only has two or fewerfilters—is there any special provisionregarding individual filter turbiditymonitoring?

Yes, if your system only consists oftwo or fewer filters, you may conductcontinuous monitoring of combinedfilter effluent turbidity in lieu ofindividual filter effluent turbiditymonitoring. Continuous monitoringmust meet the same requirements setforth in § 141.560(a) through (d) and§ 141.561.

§ 141.563 What follow-up action is mysystem required to take based oncontinuous turbidity monitoring?

Follow-up action is requiredaccording to the following tables:

If * * * Your system must * * *

(a) The turbidity of an individual filter (or the tur-bidity of combined filter effluent (CFE) for sys-tems with 2 filters that monitor CFE in lieu ofindividual filters) exceeds 1.0 NTU in two con-secutive recordings 15 minutes apart.

Report to the State by the 10th of the following month and include the filter number(s), cor-responding date(s), turbidity value(s) which exceeded 1.0 NTU, and the cause (if known) forthe exceedance(s).

If a system was required to report to the State* * * Your system must * * *

(b) For three months in a row and turbidity ex-ceeded 1.0 NTU in two consecutive record-ings 15 minutes apart at the same filter (orCFE for systems with 2 filters that monitorCFE in lieu of individual filters).

Conduct a self-assessment of the filter(s) within 14 days of the day the filter exceeded 1.0NTU in two consecutive measurements for the third straight month unless a CPE as speci-fied in paragraph (c) of this section was required. Systems with 2 filters that monitor CFE inlieu of individual filters must conduct a self assessment on both filters. The self-assessmentmust consist of at least the following components: assessment of filter performance; devel-opment of a filter profile; identification and prioritization of factors limiting filter performance;assessment of the applicability of corrections; and preparation of a filter self-assessment re-port. If a self-assessment is required, the date that it was triggered and the date that it wascompleted.

(c) For two months in a row and turbidity ex-ceeded 2.0 BTU in 2 consecutive recordings15 minutes apart at the same filter (or CFEfor systems with 2 filters that monitor CFE inlieu of individual filters).

Arrange to have a comprehensive performance evaluation (CPE) conducted by the State or athird party approved by the State not later than 60 days following the day the filter exceeded2.0 NTU in two consecutive measurements for the second straight month. If a CPE hasbeen completed by the State or a third party approved by the State within the 12 priormonths or the system and State are jointly participating in an ongoing Comprehensive Tech-nical Assistance (CTA) project at the system, a new CPE is not required. If conducted, aCPE must be completed and submitted to the State no later than 120 days following theday the filter exceeded 2.0 NTU in two consecutive measurements for the second straightmonth.

§ 141.564 My system practices limesoftening—is there any special provisionregarding my individual filter turbiditymonitoring?

If your system utilizes lime softening,you may apply to the State foralternative turbidity exceedance levelsfor the levels specified in the table in

§ 141.563. You must be able todemonstrate to the State that higherturbidity levels are due to limecarryover only, and not due to degradedfilter performance.

Reporting and RecordkeepingRequirements

§ 141.570 What does subpart T require thatmy system report to the State?

This subpart T requires your systemto report several items to the State. Thefollowing table describes the itemswhich must be reported and the

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frequency of reporting. Your system isrequired to report the informationdescribed in the following table, if it is

subject to the specific requirementshown in the first column.

Correspondingrequirement Description of information to report Frequency

(a) Combined Filter Effluent Re-quirements.

(§§ 141.550–141.553)

(1) The total number of filtered water turbidity measurementstaken during the month.

By the 10th of the following month.

(2) The number and percentage of filtered water turbiditymeasurements taken during the month which are less thanor equal to your system’s required 95th percentile limit.

By the 10th of the following month.

(3) The date and value of any turbidity measurements takenduring the month which exceed the maximum turbidityvalue for your filtration system.

By the 10th of the following month.

(b) Individual Turbidity Require-ments.

(§§ 141.560–141.564)

(1) That your system conducted individual filter turbidity moni-toring during the month.

By the 10th of the following month.

(2) The filter number(s), corresponding date(s), and the tur-bidity value(s) which exceeded 1.0 NTU during the month,but only if 2 consecutive measurements exceeded 1.0 NTU.

By the 10th of the following month.

(3) If a self-assessment is required, the date that it was trig-gered and the date that it was completed.

By the 10th of the following month (or 14 daysafter the self-assessment was triggered onlyif the self-assessment was triggered duringthe last four days of the month)

(4) If a CPE is required, that the CPE is required and thedate that it was triggered.

By the 10th of the following month.

(5) Copy of completed CPE report ........................................... Within 120 days after the CPE was triggered.(c) Disinfection Profiling ............(§§ 141.530–141.536)

(1) Results of optional monitoring which show TTHM levels<0.064 mg/l and HAA5 levels <0.048 mg/l (Only if your sys-tem wishes to forgo profiling) or that your system hasbegun disinfection profiling.

(i) For systems serving 500–9,999 by July 1,2003;

(ii) For systems serving fewer than 500 byJanuary 1, 2004.

(d) Disinfection Benchmarking ..(§§ 141.540–141.544)

(1) A description of the proposed change in disinfection, yoursystem’s disinfection profile for Giardia lamblia (and, if nec-essary, viruses) and disinfection benchmark, and an anal-ysis of how the proposed change will affect the current lev-els of disinfection.

Anytime your system is considering a signifi-cant change to its disinfection practice.

§ 141.571 What records does subpart Trequire my system to keep?

Your system must keep several typesof records based on the requirements ofsubpart T, in addition to recordkeeping

requirements under § 141.75. Thefollowing table describes the necessaryrecords, the length of time these recordsmust be kept, and for whichrequirement the records pertain. Your

system is required to maintain recordsdescribed in this table, if it is subject tothe specific requirement shown in thefirst column.

Corresponding requirement Description of necessary records Duration of timerecords must be kept

(a) Individual Filter Turbidity Requirements .........................(§§ 141.560–141.564)

Results of individual filter monitoring ................................... At least 3 years.

(b) Disinfection Profiling .......................................................(§§ 141.530–141.536)

Results of Profile (including raw data and analysis) ........... Indefinitely.

(c) Disinfection Benchmarking .............................................(§§ 141.540–141.544)

Benchmark (including raw data and analysis) .................... Indefinitely.

PART 142—NATIONAL PRIMARYDRINKING WATER REGULATIONSIMPLEMENTATION

15. The authority citation for Part 142continues to read as follows:

Authority: 42 U.S.C. 300f, 300g–1, 300g–2,300g–3, 300g–4, 300g–5, 300g–6, 300j–4,300j–9, and 300j–11.

16. Section 142.14 is amended byrevising paragraphs (a)(3), (a)(4)(i),(a)(4)(ii) introductory text, and (a)(7) toread as follows:

§ 142.14 Records kept by States.

(a) * * *(3) Records of turbidity measurements

must be kept for not less than one year.The information retained must be setforth in a form which makes possiblecomparison with the limits specified in§§ 141.71, 141.73, 141.173 and 141.175,141.550–141.553 and 141.560–141.564of this chapter. Until June 29, 1993, forany public water system which isproviding filtration treatment and untilDecember 30, 1991, for any public watersystem not providing filtrationtreatment and not required by the State

to provide filtration treatment, recordskept must be set forth in a form whichmakes possible comparison with thelimits contained in § 141.13 of thischapter.

(4)(i) Records of disinfectant residualmeasurements and other parametersnecessary to document disinfectioneffectiveness in accordance with§§ 141.72 and 141.74 of this chapter andthe reporting requirements of §§ 141.75,141.175, and 141.570, of this chaptermust be kept for not less than one year.

(ii) Records of decisions made on asystem-by-system and case-by-case basis

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under provisions of part 141, subpart H,subpart P, or subpart T of this chapter,must be made in writing and kept by theState.* * * * *

(7) Any decisions made pursuant tothe provisions of part 141, subpart P orsubpart T of this chapter.

(i) Records of systems consulting withthe State concerning a modification todisinfection practice under§§ 141.170(d), 141.172(c), and 141.542of this chapter, including the status ofthe consultation.

(ii) Records of decisions that a systemusing alternative filtration technologies,as allowed under §§ 141.173(b) and§ 141.552 of this chapter, canconsistently achieve a 99.9 percentremoval and/or inactivation of Giardialamblia cysts, 99.99 percent removaland/or inactivation of viruses, and 99percent removal of Cryptosporidiumoocysts. The decisions must includeState-set enforceable turbidity limits foreach system. A copy of the decisionmust be kept until the decision isreversed or revised. The State mustprovide a copy of the decision to thesystem.

(iii) Records of systems required to dofilter self-assessment, CPE, or CCPunder the requirements of §§ 141.175and 141.563 of this chapter.* * * * *

17. Section 142.16 is amended byrevising paragraph (g) introductory textand adding paragraph (j) to read asfollows:

§ 142.16 Special primacy requirements.* * * * *

(g) Requirements for States to adopt40 CFR part 141, Subpart P EnhancedFiltration and Disinfection—SystemsServing 10,000 or More People. Inaddition to the general primacyrequirements enumerated elsewhere inthis part, including the requirement thatState provisions are no less stringentthan the Federal requirements, an

application for approval of a Stateprogram revision that adopts 40 CFRpart 141, Subpart P Enhanced Filtrationand Disinfection—Systems Serving10,000 or More People, must contain theinformation specified in this paragraph:* * * * *

(j) Requirements for States to adopt 40CFR part 141, Subpart T EnhancedFiltration and Disinfection—SystemsServing Fewer than 10,000 People. Inaddition to the general primacyrequirements enumerated elsewhere inthis part, including the requirement thatState provisions are no less stringentthan the Federal requirements, anapplication for approval of a Stateprogram revision that adopts 40 CFRpart 141, Subpart T Enhanced Filtrationand Disinfection—Systems ServingFewer than 10,000 People, must containthe information specified in thisparagraph:

(1) Enforceable requirements. Statesmust have rules or other authority torequire systems to participate in aComprehensive Technical Assistance(CTA) activity, the performanceimprovement phase of the CompositeCorrection Program (CCP). The Statemust determine whether a CTA must beconducted based on results of a CPEwhich indicate the potential forimproved performance, and a finding bythe State that the system is able toreceive and implement technicalassistance provided through the CTA. ACPE is a thorough review and analysisof a system’s performance-basedcapabilities and associatedadministrative, operation andmaintenance practices. It is conductedto identify factors that may be adverselyimpacting a plant’s capability to achievecompliance. During the CTA phase, thesystem must identify and systematicallyaddress factors limiting performance.The CTA is a combination of utilizingCPE results as a basis for follow-up,implementing process control priority-setting techniques and maintaining

long-term involvement to systematicallytrain staff and administrators.

(2) State practices or procedures.(i) Section 141.530–141.536—How the

State will approve a more representativedata set for optional TTHM and HAA5monitoring and profiling.

(ii) Section 141.536 of this chapter—How the State will approve a method tocalculate the logs of inactivation forviruses for a system that uses eitherchloramines, ozone, or chlorine dioxidefor primary disinfection.

(iii) Section 141.542 of this chapter—How the State will consult with thesystem and approve significant changesto disinfection practices.

(iv) Section 141.552 of this chapter—For filtration technologies other thanconventional filtration treatment, directfiltration, slow sand filtration, ordiatomaceous earth filtration, how theState will determine that a public watersystem may use a filtration technologyif the PWS demonstrates to the State,using pilot plant studies or other means,that the alternative filtration technology,in combination with disinfectiontreatment that meets the requirements of§ 141.72(b) of this chapter, consistentlyachieves 99.9 percent removal and/orinactivation of Giardia lamblia cystsand 99.99 percent removal and/orinactivation of viruses, and 99 percentremoval of Cryptosporidium oocysts.For a system that makes thisdemonstration, how the State will setturbidity performance requirements thatthe system must meet 95 percent of thetime and that the system may notexceed at any time at a level thatconsistently achieves 99.9 percentremoval and/or inactivation of Giardialamblia cysts, 99.99 percent removaland/or inactivation of viruses, and 99percent removal of Cryptosporidiumoocysts.

[FR Doc. 02–409 Filed 1–11–02; 8:45 am]BILLING CODE 6560–50–P

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