69478 Federal Register /Vol. 63, No. 241/Wednesday, December 16, 1998/Rules … · 2018-03-17 ·...

69478 Federal Register / Vol. 63, No. 241 / Wednesday, December 16, 1998 / Rules and Regulations

ENVIRONMENTAL PROTECTIONAGENCY

40 CFR Parts 9, 141, and 142

[WH–FRL–6199–9]

RIN 2040–AC91

National Primary Drinking WaterRegulations: Interim Enhanced SurfaceWater Treatment

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

SUMMARY: In this document, EPA isfinalizing the Interim Enhanced SurfaceWater Treatment Rule (IESWTR). Thepurposes of the IESWTR are to: Improvecontrol of microbial pathogens,including specifically the protozoanCryptosporidium, in drinking water; andaddress risk trade-offs with disinfectionbyproducts. Key provisions establishedin today’s final IESWTR include: AMaximum Contaminant Level Goal(MCLG) of zero for Cryptosporidium; 2-log Cryptosporidium removalrequirements for systems that filter;strengthened combined filter effluentturbidity performance standards andindividual filter turbidity provisions;disinfection benchmark provisions toassure continued levels of microbialprotection while facilities take thenecessary steps to comply with newdisinfection byproduct standards;inclusion of Cryptosporidium in thedefinition of ground water under thedirect influence of surface water(GWUDI) and in the watershed controlrequirements for unfiltered public watersystems; requirements for covers on newfinished water reservoirs; and sanitarysurveys for all surface water systems

regardless of size. The IESWTR buildsupon the treatment techniquerequirements of the Surface WaterTreatment Rule.

EPA believes that implementation ofthe IESWTR will significantly reducethe level of Cryptosporidium in finisheddrinking water supplies throughimprovements in filtration. The Agencyestimates that the likelihood of endemicillness from Cryptosporidium willdecrease by 110,000 to 463,000 casesannually. The Agency believes that therule will also reduce the likelihood ofthe occurrence of outbreaks ofcryptosporidiosis by providing a largermargin of safety against such outbreaksfor some systems. In addition, thefiltration provisions of the rule areexpected to increase the level ofprotection from exposure to otherpathogens (i.e., Giardia or otherwaterborne bacterial or viral pathogens).

The IESWTR applies to public watersystems that use surface water orGWUDI and serve 10,000 or morepeople. The rule also requires primacyStates to conduct sanitary surveys for allsurface water and GWUDI systemsregardless of size.EFFECTIVE DATE: This regulation iseffective February 16, 1999. Compliancedates for specific components of the ruleare discussed in the SupplementaryInformation section.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 are available forreview at EPA’s Drinking Water Docket:401 M Street, SW., Rm. EB57,Washington, DC 20460 from 9 a.m. to 4p.m., Monday through Friday, excluding

legal holidays. For access to docketmaterials, please call (202) 260–3027 toschedule an appointment.

FOR FURTHER INFORMATION, CONTACT: Forgeneral information contact the SafeDrinking Water Hotline, Telephone(800) 426–4791. The Safe DrinkingWater Hotline is open Monday throughFriday, excluding Federal holidays,from 9 a.m. to 5:30 p.m. Eastern Time.For technical inquiries, contactElizabeth Corr or Paul S. Berger, Ph.D.(Microbiology), Office of Ground Waterand Drinking Water (MC 4607), U.S.Environmental Protection Agency, 401M Street SW, Washington DC 20460;telephone (202) 260–8907 (Corr) or (202)260–3039 (Berger). For Regionalcontacts see SupplementaryInformation.

SUPPLEMENTARY INFORMATION: Thisregulation is effective 60 days afterpublication of FR document forpurposes of the AdministrativeProcedures Act and the CongressionalReview Act. Compliance dates forspecific components of the rule arediscussed below. Solely for judicialreview purposes, this final rule ispromulgated as of 1 p.m. Eastern TimeDecember 30, 1998 as provided in 40CFR 23.7.

Regulated entities. Entities potentiallyregulated by the IESWTR are publicwater systems that use surface water orground water under the direct influenceof surface water and serve at least10,000 people. (States are required tocarry out sanitary surveys for all surfacewater and GWUDI systems includingthose that serve less than 10,000people.) Regulated categories andentities include:

Category Examples of regulated entities

Industry ............................................................... Public Water Systems (PWSs) that use surface water or ground water under the direct influ-ence of surface water and serve at least 10,000 people

State, Local, Tribal or Federal Governments ..... PWSs that use surface water or ground water under the direct influence of surface water andserve at least 10,000 people.

This table is not intended to beexhaustive, but rather provides a guidefor readers regarding entities likely to beregulated by the IESWTR. This tablelists the types of entities that EPA isnow aware could potentially beregulated by the 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 theapplicability criteria in subpart H(§ 141.70(a)—systems subject to theSurface Water Treatment Rule) and

subpart P (§ 141.170(a)—subpart Hsystems that serve 10,000 or morepeople) of the final rule. If you havequestions regarding the applicability ofthe IESWTR to a particular entity,consult one of the persons listed in thepreceding FOR FURTHER INFORMATIONCONTACT section.

Regional Contacts

I. Kevin Reilly, Water Supply Section,JFK Federal Bldg., Room 203, Boston,MA 02203, (617) 565–3616

II. Michael Lowy, Water Supply Section,290 Broadway, 24th Floor, New York,NY 10007–1866, (212) 637–3830

III. Jason Gambatese, Drinking WaterSection (3WM41), 1650 Arch Street,Philadelphia, PA 19103–2029, (215)814–5759

IV. David Parker, Water Supply Section,345 Courtland Street, Atlanta, GA30365, (404) 562–9460

V. Kimberly Harris, Water SupplySection, 77 W. Jackson Blvd., Chicago,IL 60604, (312) 886–4239

69479Federal Register / Vol. 63, No. 241 / Wednesday, December 16, 1998 / Rules and Regulations

VI. Blake L. Atkins, Drinking WaterSection, 1445 Ross Avenue, Dallas,TX 75202, (214) 665–2297

VII. Ralph Flournoy, Drinking Water/Ground Water Management Branch,726 Minnesota Ave., Kansas City, KS66101, (913) 551–7374

VIII. Bob Clement, Public Water SupplySection (8P2–W–MS), 999 18th Street,Suite 500, Denver, CO 80202–2466,(303) 312–6653

IX. Bruce Macler, Water Supply Section,75 Hawthorne Street, San Francisco,CA 94105, (415) 744–1884

X. Wendy Marshall, Drinking WaterUnit, 1200 Sixth Avenue (OW–136),Seattle, WA 98101, (206) 553–1890

List of Abbreviations Used in ThisDocument

ASCE: American Society of CivilEngineers

ASDWA: Association of State DrinkingWater Administrators

ASTM: American Society for Testingand Materials

AWWA: American Water WorksAssociation

AWWARF: American Water WorksAssociation Research Foundation

°C: Degrees CentigradeCCP: Composite Correction ProgramCDC: Centers for Disease ControlCFE: Combined Filter EffluentCFR: Code of Federal RegulationsCPE: Comprehensive Performance

EvaluationCT: The Residual Concentration of

Disinfectant (mg/L) Multiplied by theContact Time (in minutes)

CTA: Comprehensive TechnicalAssistance

DBPs: Disinfection ByproductsDBPR: Disinfectants/Disinfection

Byproducts RuleESWTR: Enhanced Surface Water

Treatment RuleFACA: Federal Advisory Committee ActGAC: Granular Activated CarbonGAO: Government Accounting OfficeGWUDI: Ground Water Under the Direct

Influence of Surface WaterHAA5: Haloacetic acids

(Monochloroacetic, Dichloroacetic,Trichloroacetic, Monobromoaceticand Dibromoacetic Acids)

HPC: Heterotropic Plate Counthrs: HoursICR: Information Collection RuleIESWTR: Interim Enhanced Surface

Water Treatment RuleIFA: Individual Filter AssessmentLog Inactivation: Logarithm of (N0/NT)Log: Logarithm (common, base 10)LTESWTR: Long Term Enhanced

Surface Water Treatment RuleLT1: Long Term 1 Enhanced Surface

Water Treatment RuleMCL: Maximum Contaminant Level

MCLG: Maximum Contaminant LevelGoal

M–DBP: Microbial and Disinfectants/Disinfection Byproducts

MPA: Microscopic Particulate AnalysisNODA: Notice of Data AvailabilityNPDWR: National Primary Drinking

Water RegulationNT: The Concentration of Surviving

Microorganisms at Time TNTTAA: National Technology Transfer

and Advancement ActNTU: Nephelometric Turbidity UnitPE: Performance EvaluationPWS: Public Water SystemReg. Neg.: Regulatory NegotiationRIA: Regulatory Impact AnalysisRFA: Regulatory Flexibility ActRSD: Relative Standard DeviationSAB: Science Advisory BoardSDWA: Safe Drinking Water ActSWTR: Surface Water Treatment RuleTC: Total ColiformsTCR: Total Coliform RuleTTHM: Total TrihalomethanesTWG: Technical Work GroupUMRA: Unfunded Mandates Reform Actx log removal: Reduction to 1⁄10x of

original concentration

Table of Contents

I. Background

A. Statutory Requirements and LegalAuthority

B. Regulatory History1. Existing Regulations—Surface Water Treatment Rule (SWTR)—Total Coliform Rule (TCR)—Total Trihalomethane (TTHM) Rule—Information Collection Rule (ICR)2. Public Health Concerns to be Addressed3. Regulatory Negotiation Process4. Federal Advisory Committee Process5. Overview of 1994 Proposal and 1997

Notice of Data Availability

II. Summary of the Final Rule

III. Explanation of Today’s Action

A. MCLG for Cryptosporidium1. Today’s Rule2. Background and Analysis3. Summary of Major Comments

B. Removal of Cryptosporidium by Filtration1. Today’s Rule2. Background and Analysis3. Summary of Major Comments

C. Turbidity Control1. Today’s Rule2. Background and Analysis3. Summary of Major Comments

D. Disinfection Benchmark for Stage 1 DBPRMCLs

1. Today’s Rule2. Background and Analysis3. Summary of Major Comments

E. Definition of Ground Water Under theDirect Influence of Surface Water

1. Today’s Rule2. Background and Analysis3. Summary of Major Comments

F. Inclusion of Cryptosporidium inWatershed Control Requirements

1. Today’s Rule

2. Background and Analysis3. Summary of Major Comments

G. Covered Finished Water Reservoirs1. Today’s Rule2. Background and Analysis3. Summary of Major Comments

H. Sanitary Survey Requirements1. Today’s Rule2. Background and Analysis3. Summary of Major Comments

I. Compliance Schedules1. Today’s Rule2. Background and Analysis3. Summary of Major Comments

IV. State ImplementationA. Special State Primacy RequirementsB. State Recordkeeping RequirementsC. State Reporting RequirementsD. Interim Primacy

V. Economic AnalysisA. Today’s RuleB. Overview of RIA for Proposed RuleC. What’s Changed Since the Proposed RuleD. Summary of Cost AnalysisE. Household CostsF. Summary of Benefits AnalysisG. Comparison of Costs and Benefits

VI. Additional Issues Discussed in 1994Proposal and 1997 NODA

A. Inactivation of CryptosporidiumB. Giardia Inactivation CT values for

Profiling/BenchmarkingC. Cross Connection ControlD. Filter Backwash RecyclingE. Certification Criteria for Water Plant

Operators

VII. Other Requirements

A. Regulatory Flexibility ActB. 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. Executive Order 12875: Enhancing theIntergovernmental Partnership

I. Executive Order 13084: Consultation andCoordination With Indian TribalGovernments

J. Consultation with the Science AdvisoryBoard, National Drinking Water Council,and Secretary of Health and HumanServices

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

L. Submission to Congress and the GeneralAccounting Office

VIII. References

I. Background

A. Statutory Requirements and LegalAuthority

The Safe Drinking Water Act (SDWAor the Act), as amended in 1986,


requires USEPA to publish a ‘‘maximumcontaminant level goal’’ (MCLG) foreach contaminant which, in thejudgement of the USEPA Administrator,‘‘may have any adverse effect on thehealth of persons and which is knownor anticipated to occur in public watersystems’’ (Section 1412(b)(3)(A)).MCLGs are to be set at a level at which‘‘no known or anticipated adverse effecton the health of persons occur andwhich allows an adequate margin ofsafety’’ (Section 1412(b)(4)).

The Act was amended in August1996. As a result of these Amendments,several of these provisions wererenumbered and augmented withadditional language. Other sectionswere added establishing new drinkingwater requirements. Thesemodifications are outlined below.

The Act also requires that at the sametime USEPA publishes an MCLG, whichis a non-enforceable health goal, it alsomust publish a National PrimaryDrinking Water Regulation (NPDWR)that specifies either a maximumcontaminant level (MCL) or treatmenttechnique (Sections 1401(l) and1412(a)(3)). USEPA is authorized topromulgate a NPDWR ‘‘that requires theuse of a treatment technique in lieu ofestablishing a MCL,’’ if the Agency findsthat ‘‘it is not economically ortechnologically feasible to ascertain thelevel of the contaminant’’ EPA’s generalauthority to set a maximumcontaminant level goal (MCLG) andNational Primary Drinking WaterRegulation (NPDWR) applies tocontaminants that may ‘‘have an adverseeffect on the health of persons,’’ that are‘‘known to occur or there is a substantiallikelihood that the contaminant willoccur in public water systems with afrequency and at levels of public healthconcern,’’ and for which ‘‘in the solejudgement of the Administrator,regulation of such contaminant presentsa meaningful opportunity for health riskreduction for persons served by publicwater systems’’ (SDWA Section1412(b)(1)(A)).

The amendments, also require EPA,when proposing a NPDWR that includesan MCL or treatment technique, topublish and seek public comment on ananalysis of health risk reduction andcost impacts. In addition, EPA isrequired to take into consideration theeffects of contaminants upon sensitivesubpopulations (i.e. infants, children,pregnant women, the elderly, andindividuals with a history of seriousillness), and other relevant factors.(Section 1412 (b)(3)(C)).

The amendments established anumber of regulatory deadlines,including schedules for a Stage 1

Disinfection Byproduct Rule (DBPR), anInterim Enhanced Surface WaterTreatment Rule (IESWTR), a Long TermFinal Enhanced Surface WaterTreatment Rule (LTESWTR) affectingPublic Water Systems (PWSs) that serveunder 10,000 people, and a Stage 2DBPR (Section 1412(b)(2)(C)). The Actas amended also requires EPA topromulgate regulations to address filterbackwash (Section 1412(b)(14)) and topromulgate regulations specifyingcriteria for requiring disinfection ‘‘asnecessary’’ for ground water systems.

Finally, as part of the 1996 SDWAAmendments, recordkeepingrequirements were modified to apply toevery person who is subject to arequirement of this title or who is agrantee (Section 1445(a)(1)(A)). Suchpersons are required to establish andmaintain such records, make suchreports, conduct such monitoring, andprovide such information as theAdministrator may reasonably requireby regulation.

B. Regulatory History

1. Existing Regulations

Surface Water Treatment Rule (SWTR)Under the Surface Water Treatment

Rule (SWTR) (54 FR 27486, June 29,1989) (EPA, 1989b), EPA set maximumcontaminant level goals of zero forGiardia lamblia, viruses, and Legionella;and promulgated National PrimaryDrinking Water Regulations for all PWSsusing surface water sources or groundwater sources under the direct influenceof surface water. The SWTR includestreatment technique requirements forfiltered and unfiltered systems that areintended to protect against the adversehealth effects of exposure to Giardialamblia, viruses, and Legionella, as wellas many other pathogenic organisms.Briefly, those requirements include (1)requirements for maintenance of adisinfectant residual in the distributionsystem; (2) removal and/or inactivationof 3 log (99.9%) for Giardia and 4 log(99.99%) for viruses; (3) combined filtereffluent turbidity performance standardof 5 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.

Total Coliform Rule (TCR)The Total Coliform Rule (TCR) (54 FR

27544, June 29, 1989) applies to allpublic water systems (EPA, 1989c). Thisregulation sets compliance with theMaximum Contaminant Level (MCL) for

total coliforms (TC) as follows. Forsystems that collect 40 or more samplesper month, no more than 5.0% of thesamples may be TC-positive; for thosethat collect fewer than 40 samples, nomore than one sample may be TC-positive. In addition, if two consecutivesamples in the system are TC-positive,and one is also fecal coliform or E. coli-positive, then this is defined as an acuteviolation of the MCL. If a systemexceeds the MCL, it must notify thepublic using mandatory languagedeveloped by the EPA. The requiredmonitoring frequency for a systemdepends on the number of peopleserved and ranges from 480 samples permonth for the largest systems to onceannually for certain of the smallestsystems. All systems must have awritten plan identifying where samplesare to be collected.

If a system has a TC-positive sample,it must test that sample for the presenceof fecal coliforms or E. coli. The systemmust also collect a set of repeat samples,and analyze for TC (and fecal coliformor E. coli if necessary) within 24 hoursof being notified of a TC-positivesample.

The TCR also requires an on-siteinspection (referred to as a sanitarysurvey) every 5 years for each systemthat collects fewer than five samples permonth. (This requirement is extended toevery10 years for non-communitysystems using only protected anddisinfected ground water.)

Total Trihalomethane (TTHM) RuleIn November 1979 (44 FR 68624)

(EPA, 1979) EPA set an interim MCL fortotal trihalomethanes (TTHM) of 0.10mg/L as an annual average. Complianceis defined on the basis of a runningannual average of quarterly averages ofall samples. The value for each sampleis the sum of the measuredconcentrations of chloroform,bromodichloromethane,dibromochloromethane and bromoform.

The interim TTHM standard onlyapplies to community water systemsusing surface water and/or ground waterserving at least 10,000 people that adda disinfectant to the drinking waterduring any part of the treatment process.At their discretion, States may extendcoverage to smaller PWSs; however,most States have not exercised thisoption.

Information Collection Rule (ICR)The Information Collection Rule (ICR)

is a monitoring and data reporting rulethat was promulgated on May 14, 1996(61 FR 24354) (EPA, 1996b). Thepurpose of the ICR is to collectoccurrence and treatment information to


help evaluate the need for possiblechanges to the current SWTR andexisting microbial treatment practices,and to help evaluate the need for futureregulation for disinfectants anddisinfection byproducts (DBPs). The ICRwill provide EPA with additionalinformation on the national occurrencein drinking water of (1) chemicalbyproducts that form when disinfectantsused for microbial control react withnaturally occurring compounds alreadypresent in source water and (2) disease-causing microorganisms, includingCryptosporidium, Giardia, and viruses.The ICR will also provide engineeringdata on how PWSs currently control forsuch contaminants. This information isbeing collected because the 1992Regulatory Negotiating (Reg. Neg.)Committee on microbial pathogens anddisinfectants and DBPs concluded thatadditional information was needed toassess the potential health problemcreated by the presence of DBPs andpathogens in drinking water and toassess the extent and severity of risk inorder to make sound regulatory andpublic health decisions. The ICR willalso provide information to supportregulatory impact analyses for variousregulatory options, and to help developmonitoring strategies for cost-effectivelyimplementing regulations.

The ICR pertains to large public watersystems serving populations of at least100,000; a more limited set of ICRrequirements pertain to ground watersystems serving between 50,000 and100,000 people. About 300 PWSsoperating 500 treatment plants areinvolved with the extensive ICR datacollection. Under the ICR, these PWSsmonitor for water quality factorsaffecting DBP formation and DBPswithin the treatment plant and in thedistribution system monthly for 18months. In addition, PWSs mustprovide operating data and a descriptionof their treatment plant design andsurface water systems must monitor forbacteria, viruses, and protozoa. Finally,a subset of PWSs must performtreatment studies, using either granularactivated carbon (GAC) or membraneprocesses, to evaluate DBP precursorremoval and control of DBPs.Monitoring for treatment studyapplicability began in September 1996.The remaining occurrence monitoringbegan in July 1997.

One initial intent of the ICR was tocollect pathogen occurrence data andother information for use in developingthe Interim Enhanced Surface WaterTreatment Rule (IESWTR) and toestimate national costs for varioustreatment options. However, because ofdelays in promulgating the ICR and

technical difficulties associated withlaboratory approval and review offacility sampling plans, ICR monitoringdid not begin until July 1, 1997, whichwas later than originally anticipated. Asa result of this delay and the newstatutory deadlines for promulgating theStage 1 DBPR and IESWTR in Novemberof 1998 (resulting from the 1996 SDWAamendments), ICR data were notavailable in time to support these rules.In place of the ICR data, the Agencyworked with stakeholders to identifyother sources of data developed since1994 that could be used to support thedevelopment of the Stage 1 DBPR andIESWTR. EPA will continue to workwith stakeholders in analyzing andusing the comprehensive ICR data andresearch for developing future EnhancedSurface Water Treatment requirementsand the Stage 2 DBPR.

2. Public Health Concerns To BeAddressed

In 1990, EPA’s Science AdvisoryBoard (SAB), an independent panel ofexperts established by Congress, citeddrinking water contamination as one ofthe most important environmental risksand indicated that disease-causingmicrobial contaminants (i.e., bacteria,protozoa and viruses) are probably thegreatest remaining health riskmanagement challenge for drinkingwater suppliers (EPA/SAB, 1990).Information on the number ofwaterborne disease outbreaks from theU.S. Centers for Disease Control andPrevention (CDC) underscores thisconcern. CDC indicates that, between1980 and 1996, 401 waterborne diseaseoutbreaks were reported, with over750,000 associated cases of disease(Craun 1998, 1997a; Kramer et al 1996).During this period, a number of agentswere implicated as the cause, includingprotozoa, viruses and bacteria, as wellas several chemicals. Most of the cases(but not outbreaks) were associated withsurface water, and specifically with asingle outbreak of cryptosporidiosis inMilwaukee (over 400,000 cases)(MacKenzie et al, 1994).

It is important to note that for anumber of reasons, the CDC reports maysubstantially understate the actualnumber of waterborne disease outbreaksand cases in the U.S. First, few Stateshave an active outbreak surveillanceprogram. Second, disease outbreaks areoften not recognized in a community or,if recognized, are not traced to thedrinking water source. Third, a largenumber of people experiencinggastrointestinal illness (predominantlydiarrhea) do not seek medical attention.Fourth, physicians may often not havea broad enough community-wide basis

of information to attributegastrointestinal illness to any specificorigin such as a drinking water source.Finally, an unknown but probablysignificant portion of waterbornedisease is endemic (i.e., not associatedwith an outbreak), and thus is evenmore difficult to recognize.

Waterborne disease is usually acute(i.e., sudden onset and typically lastinga short time in healthy people). Somepathogens (e.g., Giardia,Cryptosporidium) may cause extendedillness, sometimes lasting months orlonger, in otherwise healthyindividuals. Most waterborne pathogenscause gastrointestinal illness, withdiarrhea, abdominal discomfort, nausea,vomiting, and/or other symptoms. Otherwaterborne pathogens cause, or at leastare associated with, more seriousdisorders such as hepatitis, gastriccancer, peptic ulcers, myocarditis,swollen lymph glands, meningitis,encephalitis, and a myriad of otherdiseases.

Gastrointestinal illness may bechronic in vulnerable populations (e.g.,immunocompromised individuals). Theseverity and duration of illness is oftengreater in immunocompromised personsthan in healthy individuals and may befatal among this population. Forinstance, a follow-up study of the 1993Milwaukee waterborne disease outbreakreported that at least 50Cryptosporidium-associated deathsoccurred among the severelyimmunocompromised (Hoxie et al.,1997). Immunocompromised personsinclude infants, pregnant women, theelderly, and especially those withseverely weakened immune systems(e.g., AIDS patients, those receivingtreatment for certain types of cancer,organ-transplant recipients and peopleon immunosuppressant drugs) (Gerba etal., 1996).

With specific reference tocryptosporidiosis, the disease is causedby ingestion of environmentally-resistant Cryptosporidium oocysts,which are readily carried by thewaterborne route. Humans and otheranimals may excrete these oocysts.Transmission of this disease oftenoccurs through ingestion of the infectiveoocysts from contaminated water orfood, but may also result from direct orindirect contact with infected persons oranimals (Casemore, 1990; Cordell andAddiss, 1994). Symptoms ofcryptosporidiosis include typicalgastrointestinal symptoms (Current etal., 1983). As noted above, these maypersist for several days to severalmonths.

While cryptosporidiosis is generally aself-limiting disease with a complete


recovery in otherwise healthy persons,it can be very serious inimmunosuppressed persons. EPA has aparticular concern regarding drinkingwater exposure to Cryptosporidium,especially in severelyimmunocompromised persons, becausethere is no effective therapeutic drug tocure the disease. There have been anumber of waterborne disease outbreakscaused by Cryptosporidium in theUnited States, United Kingdom andmany other countries (Rose, 1997).There appears to be an immuneresponse to Cryptosporidium, but it isnot known if this results in protection(Fayer and Ungar, 1986).

One of the key regulations EPA hasdeveloped and implemented to counterpathogens in drinking water is theSWTR. Among its provisions, the rulerequires that a surface water systemhave sufficient treatment to reduce thesource water concentration of Giardiaand viruses by at least 99.9% (3 log) and99.99% (4 log), respectively. Ashortcoming of the SWTR is that therule does not specifically control for theprotozoan Cryptosporidium. The firstreport of a recognized outbreak causedby Cryptosporidium was publishedduring the development of the SWTR(D’Antonio et al., 1985).

In terms of occurrence,Cryptosporidium is common in theenvironment. Runoff from unprotectedwatersheds allows transport of thesemicroorganisms to water bodies used asintake sites for drinking water treatmentplants. A particular public healthchallenge is that simply increasingexisting disinfection levels above thosemost commonly practiced in the UnitedStates today does not appear to be aneffective strategy for controllingCryptosporidium, because theCryptosporidium oocyst is especiallyresistant to disinfection practicescommonly used at water treatmentplants. Today’s rule addresses theconcern of passage of Cryptosporidiumthrough physical removal processesduring water treatment. It alsostrengthens the effectiveness andreliability of physical removal forparticulate matter and microorganismsin general, thereby reducing thelikelihood of the disinfection barrierbeing over challenged. Waterbornedisease outbreaks have been associatedwith a high level of particles passingthrough a water treatment plant (Foxand Lytle, 1996). This presents asignificant public health concern.Hence, there is a need to optimizetreatment reliability and to enhancephysical removal efficiencies tominimize the Cryptosporidium levels infinished water. This rule, with tightened

turbidity performance criteria andrequired individual filter monitoring, isformulated to address these publichealth concerns.

3. Regulatory Negotiation ProcessIn 1992 EPA initiated a negotiated

rulemaking to address public healthconcerns associated with disinfectants,DBPs and microbial pathogens. Thenegotiators included representatives ofState and local health and regulatoryagencies, public water systems, electedofficials, consumer groups andenvironmental groups. The Reg. Neg.Committee met from November 1992through June 1993.

Early in the process, the negotiatorsagreed that large amounts of informationnecessary to understand how tooptimize the use of disinfectants toconcurrently minimize microbial andDBP risk on a plant-specific basis wereunavailable. Nevertheless, the Reg. Neg.Committee agreed that EPA propose aStage 1 DBPR to extend coverage to allcommunity and nontransientnoncommunity water systems that usedisinfectants, reduce the current TTHMMCL, regulate additional DBPs, setlimits for the use of disinfectants, andreduce the level of organic precursorcompounds in the source water thatmay react with disinfectants to formDBPs.

EPA’s most significant concern indeveloping regulations for disinfectantsand DBPs was the need to ensure thatadequate treatment be maintained forcontrolling risks from microbialpathogens. One of the major goalsaddressed by the Reg. Neg. Committeewas to develop an approach that wouldreduce the level of exposure fromdisinfectants and DBPs withoutundermining the control of microbialpathogens. The intention was to ensurethat drinking water is microbiologicallysafe at the limits set for disinfectantsand DBPs and that these chemicals donot pose an unacceptable health risk atthese limits. Thus, the Reg. Neg.Committee also considered a range ofmicrobial issues and agreed that EPAshould also propose a companionmicrobial rule (IESWTR).

Following months of intensivediscussions and technical analysis, theReg. Neg. Committee recommended thedevelopment of three sets of rules: atwo-staged approach for the DBPs(proposal: 59 FR 38668, July 29, 1994)(EPA, 1994a), an ‘‘interim’’ ESWTR(proposal: 59 FR 38832, July 29, 1994)(EPA, 1994b) and ‘‘long-term’’ ESWTR,and an Information Collection Rule(proposal: 59 FR 6332, February 10,1994) (EPA, 1994c) (promulgation:61FR24354, May 14, 1996) (EPA,

1996b). The approach used indeveloping these proposals consideredthe constraints of simultaneouslytreating water to control for bothmicrobial contaminants anddisinfectants/DBPs.

The Reg. Neg. Committee agreed thatthe schedules for IESWTR andLTESWTR should be ‘‘linked’’ to theschedule for the Stage 1 DBPR to assuresimultaneous compliance and abalanced risk-risk basedimplementation. The Reg. Neg.Committee agreed that additionalinformation on health risk, occurrence,treatment technologies, and analyticalmethods needed to be developed inorder to better understand the risk-risktradeoff, and how to accomplish anoverall reduction in health risks fromboth pathogens and disinfectants/DBPs.

Finally, the Reg. Neg. Committeeagreed that to develop a reasonable setof rules and to understand more fullythe limitations of the current SWTRadditional field data were critical. Thus,a key component of the regulationnegotiation agreement was thepromulgation of the ICR previouslydescribed.

4. Federal Advisory Committee ProcessIn May 1996, the Agency initiated a

series of public informational meetingsto provide an update on the status of the1994 proposal and to review new datarelated to microbial and DBP regulationsthat had been developed since July1994. In August 1996, Congress enactedthe 1996 SDWA Amendments whichcontained a number of newrequirements, as discussed above, aswell as specifying deadlines for finalpromulgation of the IESWTR and Stage1 DBPR. To meet these deadlines and tomaximize stakeholder participation, theAgency established the Microbial-Disinfectants/Disinfection Byproducts(M–DBP) Advisory Committee under theFederal Advisory Committee Act(FACA) in March 1997, to collect, share,and analyze new information and data,as well as to build consensus on theregulatory implications of this newinformation. The Committee consistedof 17 members representing EPA, Stateand local public health and regulatoryagencies, local elected officials, drinkingwater suppliers, chemical andequipment manufacturers, and publicinterest groups.

The M–DBP Advisory Committee metfive times in March through July 1997to discuss issues related to the IESWTRand Stage 1 DBPR. Technical supportfor these discussions was provided by aTechnical Work Group (TWG)established by the Committee at its firstmeeting in March 1997. The


Committee’s activities resulted in thecollection, development, evaluation,and presentation of substantial new dataand information related to key elementsof both proposed rules. The Committeereached agreement on a number ofmajor issues that were discussed inNotices of Data Availability (NODA) forthe IESWTR (62 FR 59486, November 3,1997) (EPA, 1997a) and the Stage 1DBPR (62 FR 59388, November 3, 1997)(EPA, 1997b). The major issuesaddressed by the Committee and in theNODAs include: (1) Maintain theproposed MCLs for TTHMs, HAA5 andbromate; (2) modify the enhancedcoagulation requirements as part of DBPcontrol; (3) include a microbialbenchmarking/profiling to provide amethodology and process by which aPWS and the State, working together,assure that there will be no significantreduction in microbial protection as theresult of modifying disinfectionpractices in order to meet MCLs forTTHM and HAA5; (4) continue creditfor compliance with applicabledisinfection requirements fordisinfection applied at any point priorto the first customer, consistent with theexisting SWTR; (5) modify the turbidityperformance requirements and addrequirements for individual filters; (6)establish an MCLG for Cryptosporidium;(7) add requirements for removal ofCryptosporidium; (8) provide formandatory sanitary surveys; and (9) acommitment to additional analysis ofthe role of Cryptosporidium inactivationas part of a multiple barrier concept inthe context of a subsequent FederalRegister microbial proposal. The newdata and analysis supporting thetechnical areas of agreement weresummarized and explained at length inEPA’s 1997 NODAs. The Committee’srecommendations are embodied in anAgreement In Principle document datedJuly 15, 1997.

5. Overview of 1994 Proposal and 1997Notice of Data Availability

EPA proposed to amend the SurfaceWater Treatment Rule in 1994 toprovide additional protection againstdisease-causing organisms (pathogens)in drinking water (59 FR 38832: July 29,1994). In November 1997 EPApublished a Notice of Data Availability(62 FR 59486) (EPA, 1997a, b) thatsummarized the 1994 proposal;described new data and information thatthe Agency had obtained and analysesthat had been developed since theproposal; provided informationconcerning the July 1997recommendations of the M–DBPAdvisory Committee described above onkey issues related to the proposal; and

requested comment on theserecommendations as well as on otherregulatory implications that flowed fromthe new data and information. TheAgency also solicited additional dataand information that were relevant tothe issues discussed in the Notice. Inaddition, EPA provided notice that theAgency was re-opening the commentperiod for the 1994 proposal for 90 days.EPA also requested that any informationthat members of the public would likethe Agency to consider as part of thefinal rule development processregarding data or views submitted to theAgency since the close of the commentperiod on the 1994 proposal be formallyresubmitted during the reopened 90-daycomment period unless already in theunderlying record in the Docket for theNotice of Data Availability.

II. Summary of the Final RuleThe primary purposes of the IESWTR

are (1) to improve control of microbialpathogens in drinking water,particularly for the protozoanCryptosporidium, and (2) to guardagainst significant increases inmicrobial risk that might otherwiseoccur when systems implement theStage 1 Disinfectants/DisinfectionByproducts Rule. Major components ofthe IESWTR include the followingprovisions:

(a) A Maximum Contaminant LevelGoal (MCLG) of zero is established forthe protozoan genus Cryptosporidium.

(b) Surface water systems serving10,000 or more people, that are requiredto filter under the SWTR, must achieveat least 2 log removal ofCryptosporidium. Systems that useconventional or direct filtration meetthis requirement if they comply withstrengthened turbidity performancestandards for combined filter effluent(described below) and the currentrequirements under the SWTR (e.g.,meet design and operating conditions asspecified by the State). Systems that useslow sand filtration or diatomaceousearth meet the 2 log removalrequirement if they are in compliancewith existing turbidity performancestandards under the SWTR (less than orequal to 1 NTU in at least 95% ofmeasurements taken each month or, forslow sand, alternative criteria asapproved by the State; and a maximumof 5 NTU).

(c) The rule includes a series ofrequirements related to turbidity. Theseaddress the following:

Strengthened turbidity performancerequirements for the combined filtereffluent. For all surface water or GWUDIsystems that use conventional treatmentor direct filtration, serve 10,000 or more

people, and are required to filter: (a) Theturbidity level of a system’s combinedfiltered water at each plant must be lessthan or equal to 0.3 NTU in at least 95percent of the measurements taken eachmonth, and (b) the turbidity level of asystem’s combined filtered water at eachplant must at no time exceed 1 NTU.For both the maximum and the 95thpercentile requirements, compliance isdetermined based on measurements ofthe combined filter effluent at four-hourintervals.

Individual Filter Requirements. Allsurface water or GWUDI systems thatuse conventional or direct filtration,serve 10,000 or more people, and arerequired to filter must conductcontinuous monitoring of turbidity foreach individual filter and must providean exceptions report to the State on amonthly basis. Exceptions reportingmust include the following: (1) Anyindividual filter with a turbidity levelgreater than 1.0 NTU based on twoconsecutive measurements fifteenminutes apart; and (2) any individualfilter with a turbidity level greater than0.5 NTU at the end of the first 4 hoursof filter operation based on twoconsecutive measurements fifteenminutes apart. A filter profile (which isa graphical representation of anindividual filter performance) must beproduced within seven days of theexceedance if no obvious reason for theabnormal filter performance can beidentified.

If an individual filter has turbiditylevels greater than 1.0 NTU based ontwo consecutive measurements fifteenminutes apart at any time in each ofthree consecutive months, the systemmust make an exceptions report andconduct a self-assessment of the filter. Ifan individual filter has turbidity levelsgreater than 2.0 NTU based on twoconsecutive measurements fifteenminutes apart at any time in each of twoconsecutive months, the system mustmake an exception report and arrangefor the conduct of a ComprehensivePerformance Evaluation (CPE) by theState or a third party approved by theState.

State Authority. States must haverules or other authority to requiresystems to conduct a CompositeCorrection Program (CCP) and to assurethat systems implement any follow-uprecommendations that result as part ofthe CCP. The CCP consists of twoelements—a CPE and ComprehensiveTechnical Assistance (CTA). The CPE isa thorough review and analysis of aplant’s performance-based capabilitiesand associated administrative, operationand maintenance practices. It isconducted to identify factors that may


be adversely impacting a plant’scapability to achieve compliance andemphasizes approaches that can beimplemented without significant capitalimprovements. The CPE must includethe following components: (1)Assessment of plant performance; (2)evaluation of major unit processes; (3)identification and prioritization ofperformance limiting factors; (4)assessment of the applicability ofcomprehensive technical assistance; and(5) preparation of a CPE report. A CTAis the performance improvement phasethat is implemented if the CPE resultsindicate improved performancepotential. During the CTA phase, thesystem must identify and systematicallyaddress plant-specific factors. The CTAis a combination of utilizing CPE resultsas a basis for follow up, implementingprocess control priority-settingtechniques, and maintaining long-terminvolvement to systematically train staffand administrators.

(d) Microbial benchmarking/profilingrequirements are included to provide amethodology and process by which apublic water system and the State,working together, assure that there willbe no significant reduction in microbialprotection as the result of significantdisinfection practice modifications inorder to meet MCLs for TTHM andHAA5. The disinfection profilingrequirement included in today’s ruleapplies to surface water systems serving10,000 or more people and which have,based on a one year running annualaverage of representative samples takenin the distribution system, (1) measuredTTHM levels of at least 80% of the MCL(0.064 mg/L) or (2) measured HAA5levels of at least 80% of the MCL (0.048mg/L). Those PWSs required to developa disinfection profile that subsequentlydecide to make a significant change indisinfection practice must consult withthe State prior to implementing such achange.

(e) States are required to conductsanitary surveys for all public watersystems using surface water or groundwater under the direct influence ofsurface water, regardless of system size.Sanitary surveys are required no lessfrequently than every three years forcommunity systems and no lessfrequently than every five years fornoncommunity systems. For communitysystems determined by the State to haveoutstanding performance based on priorsanitary surveys, subsequent sanitarysurveys may be conducted no lessfrequently than every five years. Statesmust have the appropriate rules or otherauthority to require systems to respondin writing to significant deficienciesoutlined in a sanitary survey report

within at least 45 days, indicating howand on what schedule the system willaddress significant deficiencies noted inthe survey. States must also have theappropriate rules or other authority toassure that facilities take the stepsnecessary to address significantdeficiencies identified in the surveyreport that are within the control of thePWS and its governing body.

(f) Cryptosporidium is added to thedefinition of ground water under thedirect influence of surface water (forsystems serving 10,000 or more people).

(g) Cryptosporidium is added to thewatershed protection requirements forsystems that are avoiding filtration (forsystems serving 10,000 or more people).

(h) Surface Water and GWUDIsystems serving 10,000 or more peopleare required to cover all new treatedwater reservoirs, holding tanks or otherstorage facilities for which constructionbegins after the effective date of the rule.

The Surface Water Treatment Ruleremains the base rule regulating publicwater systems that use surface waterand ground water under the influence ofsurface water. All systems, filtered andunfiltered, must continue to complywith all the requirements of the SWTRand, where applicable, meet the newrequirements of the IESWTR. TheIESWTR’s requirements for filteredsystems are intended to ensure thatwhere a filtration plant is required toprotect public health, as specified in theSWTR, that plant will be operating wellfor the removal of Cryptosporidium andother microorganisms. EPA wishes toemphasize that compliance with today’srequirements in no way relieves apublic water system of its obligation tocomply fully with pre-existing SWTRrequirements. With regard to unfilteredsystems in particular, development oftoday’s rule was based on theassumption of full compliance with allfiltration avoidance criteria in theSWTR.

Finally, EPA notes that today’sFederal Register also contains the finalStage 1 Disinfectants/DisinfectionByproducts Rule (DBPR). EPA proposedthis rule at the same time as theIESWTR and has finalized it along withthe IESWTR.

III. Explanation of Today’s Action

A. MCLG for Cryptosporidium

1. Today’s RuleThe Agency is establishing an MCLG

of zero for Cryptosporidium, asproposed. During the 1997 M–DBPAdvisory Committee discussions, theCommittee supported the proposedestablishment of an MCLG of zero forCryptosporidium. A key issue identified

by the Advisory Committee and publiccommenters was whether the MCLGshould be set at the genus level (i.e.,Cryptosporidium) or at the more specificspecies level (i.e., C. parvum). Becauseof the uncertainties regarding taxonomy,cross reactions and cross transmissionamong mammals, EPA believes it ispremature to establish theCryptosporidium MCLG at the specieslevel. In addition, the Agency believesthat establishing an MCLG forCryptosporidium at the genus level isconsistent with the Safe Drinking WaterAct, which requires EPA to set theMCLG with an adequate margin ofsafety (Section 1412(b)(4)(A)).

2. Background and AnalysisIn the 1994 proposal of the IESWTR

(59 FR 145, p. 38855; July 29, 1994),EPA proposed to establish an MCLG ofzero for Cryptosporidium. The Agencybased its proposal upon concerns aboutsignificant health effects on personsconsuming inadequately treated surfacewaters and ground water under theinfluence of surface waters. Technicaljustifications for the proposed MCLGrelied upon animal studies and humanepidemiology studies of waterborneoutbreaks of cryptosporidiosis.

Since the proposed rule, results of ahuman feeding study have becomeavailable which further warrant theestablishment of an MCLG of zero (1997NODA 59492). DuPont et al. (1995) fed29 healthy volunteers single dosesranging from 30 to 1 million C. parvumoocysts obtained from a calf. Of the 16volunteers who received 300 or moreoocysts, 88% became infected. Of thefive volunteers who received the lowestdose (30 oocysts), one became infected.According to a mathematical modelbased upon the DuPont et al. data, if anindividual ingests a single viable oocystthere is about a 0.5% chance ofinfection (Haas et al., 1996). Theprobability of infection from C. parvummay be different for different strains.

In the process of further reviewingnew information since 1994, EPA hasre-examined the issues related to settingan MCLG at the genus level versus thespecies level. This issue was discussedin some detail during the M–DBPAdvisory Committee meetings.Currently, the classification of a numberof Cryptosporidium species is based, inpart, on the animal host from whichthey were isolated. The Agency is awarethat investigators have not found aCryptosporidium species other than C.parvum that infects humans (with onehighly questionable exception). To theAgency’s knowledge, however, nohuman infectivity studies have beenconducted to date with any species


other than C. parvum. Moreover, thetaxonomy of the genus Cryptosporidiumis uncertain and changing (Tzipori andGriffiths, 1998; Fayer et al., 1997). As aresult, EPA cannot preclude thepossibility that a new classification ofthe species comprising the genusCryptosporidium may include morethan one species capable of infectinghumans. Recently, for example, Peng etal. (1997) analyzed 39 isolates of C.parvum from humans and cattle andfound they could be separated intoeither of two genotypes, one of whichcould infect humans but not cattle ormice. In the future, these two genotypesmay be separated into two differentspecies.

In addition to the taxonomic issue,the current tests for C. parvum in stoolspecimens and water, which involve themicroscopic examination of a stainedspecimen, may give positive results forCryptosporidium species other than C.parvum. Often this results because otherCryptosporidium species (as well asother microorganisms) may react withthe stains used to detect C. parvum.This is especially true for the commonlyused acid-fast stain. In addition, C.parvum oocysts do not differ in size andshape from those of C. baileyi and C.meleagridis (Arrowood, 1997). As aresult, it is not necessarily certain thatoocysts in a human fecal specimenidentified by a clinical laboratory as C.parvum are always C. parvum. (Ingeneral, clinical labs do not use a stainor other procedure that can distinguishbetween C. parvum and otherCryptosporidium species).

The Agency is aware that a fewattempts have been made to infect onetype of animal (e.g., mammals) withCryptosporidium species isolated fromother types of animals (e.g., birds),generally without success (Fayer, 1997).In addition, Graczyk et al. (1996b) foundthat C. parvum was not transmissible tofish, amphibia, or reptiles. Nevertheless,until more cross-species transmissiondata are available, the Agency cannotforeclose on the possibility that speciesother than C. parvum may be infectiveto humans. In their review of theliterature, Fayer et al. (1990) concludedthat the success of transmission studiesis contingent upon not only speciesspecificity, but also the condition andage of the oocysts, the route ofinoculation of oocysts, and the age andimmune status of the recipient.Therefore, negative results to date ontransmission are not necessarilyconclusive regarding host specificity.

EPA believes that it is prudent to setan MCLG at zero not only for taxonomicreasons but also because of concern thatcertain populations are at greater risk of

waterborne cryptosporidiosis thanothers. This concern is heightened bythe fact that currently there is no curefor cryptosporidiosis (for healthyindividuals the disease tends to be selflimiting). Thus, the importance ofprevention and avoidance of infectionbecomes even more central to EPA’sconsideration of this issue. Until thetaxonomy of Cryptosporidium has beenclarified, EPA believes that an MCLG ofzero for Cryptosporidium at the genuslevel is appropriate especially in light ofthe statutory requirement to establishMCLGs with ‘‘an adequate margin ofsafety’’.

3. Summary of Major CommentsRegarding the value of the MCLG

most commenters supported theestablishment of a MCLG of zero forCryptosporidium. Reasons that weregiven for their support included: (1)Uncertainty exists in the infective dosefor both healthy and vulnerable(immunocompromised) individuals; (2)an MCLG of zero is consistent with theregulatory approach for pathogensunder the existing Surface WaterTreatment Rule (SWTR); (3) one viableoocyst can cause an infection at least insome people; and (4) Cryptosporidiumhas particularly adverse effects onpersons with immune disorders. Nocommenter proposed an MCLG valueother than zero. Some commentersopposed any MCLG forCryptosporidium, arguing that: (1)Current levels of treatment have somelevel of effectiveness againstCryptosporidium transmission todrinking water; (2) uncertainty existsassociated with the analyticalprocedures used to detectCryptosporidium; (3) current technologylimits the ability to determine viability,infectivity, and species; and (4) theinfectivity threshold has not beendetermined.

EPA agrees with the commenters whosupported an MCLG of zero forCryptosporidium for reasons stated inthe previous section. EPA does not agreewith comments opposing any MCLG forCryptosporidium. While it is true thatcurrent levels of treatment controlCryptosporidium to some extent, studieshave found Cryptosporidium oocysts infiltered water supplies of sometreatment plants (LeChevallier, 1991b;LeChevallier, 1995). Therefore, theAgency believes that regulation ofCryptosporidium and enhancedtreatment practices are warranted.Furthermore, the effectiveness oftreatment is irrelevant to the question ofsetting an MCLG, which asks what is thelevel of (uncontrolled) Cryptosporidiumin drinking water that will pose no risk

to the health of persons. For the reasonsdiscussed, that level is at zero. Theavailability of effective treatment merelyensures that EPA can regulate to controlthe health risk from Cryptosporidiumreflected by the MCLG.

Comments which address theuncertainty related to the analyticalmethod for Cryptosporidium and thefact that current technology does notallow viability, infectivity, and speciesto be determined may relate to the issueof whether EPA establishes an MCLversus treatment techniquerequirements for Cryptosporidium.However, they are not compelling withregard to the public health goal thatshould be set for this contaminant.

With regard to the infectivitythreshold for Cryptosporidium,according to a mathematical modelbased upon the DuPont et al., 1995 data,if an individual ingests a single viableoocyst there is a 0.5% chance ofinfection (Haas et al., 1996). It is knownthat Cryptosporidium oocysts arecapable of causing an infection in bothhealthy and seriously ill individuals.Death has been associated with somecryptosporidiosis cases, particularlyamong sensitive subpopulations (i.e.,immunocompromised individuals)(Hoxie et al., 1997). For such reasons,EPA considers an MCLG of zero forCryptosporidium to be appropriate.

EPA also received comments onwhether the MCLG for Cryptosporidiumshould be set at the genus or the specieslevel. Commenters offered severalreasons for supporting an MCLG for C.parvum, as opposed toCryptosporidium. Several professed thatonly C. parvum could infect humans,and therefore EPA should establish anMCLG based on that particular species.Commenters also contended that if, infuture regulations, EPA were toestablish a treatment techniquerequirement based on theCryptosporidium density in the sourcewater, publishing an MCLG forCryptosporidium at the genus levelmight require systems to provide anadditional level of treatment forCryptosporidium species that are notknown to be infectious to humans. Incontrast, other commenters whosupported the establishment of anMCLG for Cryptosporidium at the genuslevel stated that, unless further researchjustifies an MCLG at the species level,the MCLG should be set at the genuslevel. They reasoned thatCryptosporidium method limitationsargued for setting the MCLG at thegenus level.

In response to comments that did notsupport establishing an MCLG of zerofor Cryptosporidium at the genus level,


EPA has carefully considered the issueof genus versus species level forCryptosporidium. As mentioned earlier,EPA concludes that there exists muchuncertainty regarding Cryptosporidiumtaxonomy, cross reactions and crosstransmissions. Thus, EPA cannotconclude that these other species poseno health risk. For reasons mentionedabove, the Agency believes that it ismore appropriate to establish an MCLGfor Cryptosporidium at the genus levelat this time. This decision does notaffect the level of treatment requiredunder the IESWTR. EPA will revisit theimpact of the MCLG in the context offuture rules that include considerationof risk-based options.

B. Removal of Cryptosporidium byFiltration

1. Today’s Rule

Today’s final rule establishes arequirement for 2-log removal ofCryptosporidium for surface water andGWUDI systems serving 10,000 or morepeople that must filter under the SWTR.The requirement for at least 99 percent(2-log) removal of Cryptosporidiumapplies between a point where the rawwater is not subject to recontaminationby surface water runoff and a pointdownstream before or at the firstcustomer. As discussed below, the dataavailable to EPA indicate that rapidgranular filtration systems (i.e., systemsusing conventional or direct filtration)when operated under appropriatecoagulation conditions and optimized tomeet the turbidity performancestandards of the IESWTR (less than orequal to 0.3 NTU in 95% of themeasurements each month and amaximum of 1 NTU) are achieving atleast 2-log removal.

2. Background and Analysis

The 1994 proposal to amend theSurface Water Treatment Rule includedseveral proposed treatment alternatives.Two of these alternatives—AlternativesB and C—specifically addressedCryptosporidium. Alternative Benvisioned treatment options forCryptosporidium based on levels ofsource water occurrence. Alternative Ccalled for 99% (2-log) removal ofCryptosporidium. EPA was unable toconsider Alternative B for the IESWTRbecause occurrence data and relatedanalysis from the ICR sampling andanalysis survey discussed above werenot available in time to meet thestatutory promulgation deadline ofNovember 1998. For the reasonsoutlined below and as recommended bythe M–DBP Advisory Committee, EPA isproceeding with a 2-log removal

requirement for Cryptosporidium forsurface water and GWUDI systemsserving 10,000 or more people that arerequired to filter under the SWTR.

As part of the 1997 M–DBP AdvisoryCommittee process, substantial newdata and information related to removalof Cryptosporidium by filtration werecollected, evaluated and analyzed. TheCommittee recommended adoption of a2-log Cryptosporidium removalrequirement for all surface watersystems that serve more than 10,000people and are required to filter. TheCommittee also recommended thatsystems which use rapid granularfiltration (direct filtration orconventional filtration treatment) andmeet today’s strengthened combinedfilter effluent turbidity requirementswould be in compliance with therequirement for at least a 2-log removalof Cryptosporidium. Systems which useslow sand filtration and diatomaceousearth filtration and meet existing SWTRturbidity performance requirements(less than or equal to 1 NTU for the 95thpercentile or alternative criteria asapproved by the State) also would be incompliance with the requirement for atleast a 2-log removal ofCryptosporidium.

In November of 1997, EPA issued aNotice of Data Availability (NODA)which discussed new data andinformation that the Agency hadobtained and analyses that had beendeveloped since the 1994 proposal. Italso summarized recommendations ofthe M–DBP Advisory Committee onCryptosporidium removal. The 1997NODA requested comment on the newinformation, the Advisory Committee’srecommendations, and on otherregulatory implications and impacts.

The November 3, 1997 NODAprovided new information regardingeight studies (Patania et al., 1995;Nieminski and Ongerth, 1995; Ongerthand Pecoraro, 1995; LeChevallier andNorton, 1992; LeChevallier et al., 1991b;Foundation for Water Research, 1994;Kelley et al., 1995; and West et al., 1994)that indicated that rapid granularfiltration when operated underappropriate coagulation conditions andoptimized to achieve a filtered waterturbidity of less than 0.3 NTU shouldachieve at least 2-log ofCryptosporidium removal. These studieswere analyzed as part of the 1997IESWTR NODA.

3. Summary of Major CommentsIn response to the 1994 Proposal,

most commenters addressing the issueof treatment alternatives supportedAlternative C which would require 2-logphysical removal of Cryptosporidium.

Some opposed any treatmentrequirement greater than a 2-log removaldue to a lack of better understanding ofdose-response, effectiveness oftreatment and analyses to justify thehigher treatment costs involved. Today’srule requires at least 2-log removal forCryptosporidium. EPA will revisitissues related to further control ofCryptosporidium in future rulemakings.

The majority of commenters to theNovember 1997 NODA agreed with theappropriateness of establishing a 2-logremoval requirement forCryptosporidium in the IESWTR,although some commenters hadadditional concerns. One major concernwas that a quantitative relationshipbetween removal of Cryptosporidiumand lowered turbidity was prematureand had not been established. EPAbelieves that the studies identified inthe NODA illustrate the removalefficiencies for Cryptosporidium byseveral filtration technologies. Whilethese studies demonstrated a range ofCryptosporidium log-removals, it isimportant to realize that 2-log removalwas consistently obtainable at turbiditylevels of less than 0.3 NTU whensystems were operated underappropriate coagulation conditions andoptimized to achieve a filtered waterturbidity level of less than 0.3 NTU.EPA will continue to assess data forcontrol of Cryptosporidium by physicalremoval and disinfection as it becomesavailable, and will consider such data insubsequent regulations.

Another significant issue noted byseveral commenters was that systemsshould be provided the opportunity todemonstrate greater log removal ofCryptosporidium. Consistent with a keypoint made during M–DBP AdvisoryCommittee discussions on this issue,EPA takes this opportunity to note theAgency’s position that the requirementfor at least 2-log removal is not intendedto prevent a facility from demonstratingthat it can achieve higher than 2-logremoval of Cryptosporidium on a site-specific basis or States fromdemonstrating based on site-specificinformation that a specific facility mayactually be achieving less than 2-logremoval of Cryptosporidium eventhough it is meeting strengthenedturbidity standards of 0.3 NTU for the95th percentile and a maximum of 1NTU.

C. Turbidity Control

1. Today’s Rule

Today’s rule establishes a number ofrequirements for filtration performanceand filter monitoring and reporting,outlined below, which apply to surface


water systems or ground water underthe direct influence of surface water(GWUDI) that serve 10,000 or morepeople and are required to filter underthe SWTR. The basis for theseprovisions is explained at greater lengthin background sections of the 1997IESWTR NODA.

Combined Filter Effluent RequirementsFor conventional and direct filtration

systems, the turbidity level ofrepresentative samples of a system’scombined filter effluent water must beless than or equal to 0.3 NTU in at least95 percent of the measurements takeneach month. The turbidity level ofrepresentative samples of a system’sfiltered water must at no time exceed 1NTU. For slow sand and diatomaceousearth filtration, the turbidity level ofrepresentative samples of a system’sfiltered water must be less than or equalto 1 NTU in at least 95 percent of themeasurements taken each month andthe turbidity level of representativesamples of a system’s filtered watermust at no time exceed 5 NTU (nochange from the combined filter effluentturbidity requirements in the 1989SWTR). For both the maximum and95th percentile requirements,compliance is determined based onmeasurements of the combined filtereffluent at four-hour intervals.

In carrying out these combinedeffluent requirements, and theindividual filter requirements describedbelow, systems must use methods forturbidity measurement previouslyapproved by EPA. These are Method2130B, published in Standard Methodsfor the Examination of Water andWastewater (19th ed.); Great LakesInstrument Method 2; and the revisedEPA Method 180.1, approved in August1993 in Methods for the Determinationof Inorganic Substances inEnvironmental Samples (EPA–600/R–93–100). EPA notes that today’s rulerequires the measurement of turbidity.Turbidity is a method-definedparameter. Turbidity therefore is not acandidate for, and will not be subject to,the performance-based measurementssystem.

Individual Filter RequirementsConventional and direct filtration

systems must conduct continuousmonitoring of turbidity for eachindividual filter and must provide anexceptions report to the State on amonthly basis as part of the existingcombined filter effluent reportingprocess. Exceptions reporting mustinclude the following: (1) Anyindividual filter with a turbidity levelgreater than l.0 NTU based on two

consecutive measurements fifteenminutes apart; and (2) any individualfilter with a turbidity level greater than0.5 NTU at the end of the first 4 hoursof filter operation based on twoconsecutive measurements fifteenminutes apart. The system mustproduce a filter profile for eithersituation if no obvious reason for theabnormal filter performance can beidentified. EPA is including adiscussion on filter profiles in itsguidance document on turbidity whichis currently being developed with inputfrom stakeholders.

Individual Filter Follow-Up ActivitiesIf an individual filter has turbidity

levels greater than l.0 NTU based on twoconsecutive measurements fifteenminutes apart at any time in each ofthree consecutive months, the systemmust, in addition to filing an exceptionsreport, conduct a self-assessment of thefilter. The self-assessment must consistof at least the following components: (1)Assessment of filter performance; (2)development of a filter profile; (3)identification and prioritization offactors limiting filter performance; (4)assessment of the applicability ofcorrections; and (5) preparation of afilter self-assessment report. The systemmust conduct the self-assessment within14 days of the exceedance and report tothe State that the self-assessment wasconducted. If an individual filter hasturbidity levels greater than 2.0 NTUbased on two consecutive measurementsfifteen minutes apart at any time in eachof two consecutive months, the systemmust file an exceptions report and mustno later than 30 days following theexceedance arrange for the conduct of aCPE by the State or a third partyapproved by the State. The CPE must becompleted and submitted to the State nolater than 90 days following theexceedance.

2. Background and AnalysisA primary focus of the 1994 proposal

was the establishment of treatmentrequirements that would address publichealth risks from high densities ofpathogens in poor quality source watersand from the waterborne pathogenCryptosporidium. Approaches outlinedin the 1994 proposal included treatmentrequirements based on site-specificconcentrations of pathogens in sourcewater and a proposed 2-log removalrequirement for Cryptosporidium byfiltration.

EPA specifically requested commenton what criteria, if any, should beincluded to ensure that systemsoptimize treatment plant performanceand on whether any of the existing

turbidity performance criteria should bemodified (e.g., should systems berequired to base compliance with theturbidity standards on individual filtereffluent monitoring in lieu of or inaddition to monitoring the confluence ofall filters; and should any performancestandard value be changed). In addition,the Agency also requested comment inthe 1994 proposal on possiblesupplemental requirements for Statenotification of persistent high turbiditylevels (e.g., broadening the requirementsfor State notification of turbidityexceedances).

The 1997 M-DBP Advisory Committeemeetings resulted in the collection,development, evaluation, andpresentation of substantial data andinformation related to turbidity control.The Committee’s recommendations arereflected in today’s rule.

The November 3, 1997 IESWTRNODA discussed new data andinformation regarding turbidity controlwith respect to three areas: (1) Currentturbidity levels at systems throughoutthe country; (2) individual filterperformance; and (3) turbiditymeasurement.

Current Turbidity LevelsThe November 3, 1997 NODA

discussed three data sets thatsummarized the historical turbidityperformance of various filtration plants(AWWSC, 1997; Bissonette, 1997; SAIC,1997b). These were evaluated to assessthe national impact of modifyingexisting turbidity requirements. Each ofthe data sets was analyzed to assess thecurrent performance of plants withrespect to the number of months inwhich selected 95th percentile andmaximum turbidity levels wereexceeded. The data show that upwardsof 90% of the systems are currentlymeeting the new requirements of amaximum turbidity limit of 1 NTU.With respect to the 95th percentileturbidity limit, roughly 78% of thesystems are currently meeting the newrequirement of 0.3 NTU. Estimates forsystems needing to make changes tomeet a turbidity performance limit of0.3 NTU were based on the ability ofsystems currently to meet a 0.2 NTU.This assumption was intended to takeinto account a utility’s concern withpossible turbidity measurement errorand to reflect the expectation that anumber of utilities will ‘‘aim’’ lowerthan the regulatory performance level toassure compliance. The percentage ofsystems estimated to modify treatmentpractices to meet the revised turbidityrequirements (i.e., 0.3 NTU 95thpercentile and 1 NTU maximumcombined filter effluent levels) is


approximately 50%. Based on theturbidity performance data, EPAassumed that for systems serving lessthan 100,000 people, 51.2 percent of thesystems can be expected to maketreatment changes to consistentlycomply with a monthly 95th percentilelimit of 0.3 NTU. Similarly, for systemsserving over 500,000 people, EPAassumed that 41.7 percent can beexpected to make treatment changes tocomply with a 0.3 NTU regulatory limit.For systems serving 100,000 to 500,000people, EPA assumed that 46.5 percentof systems can be expected to makechanges. As discussed in greater detailin the November 3, 1997 NODA, thetighter turbidity performance criteria forcombined filter effluent in today’s rulereflect actual current performance for asubstantial percentage of systemsnationally. Revising the turbiditycriteria effectively ensures that thesesystems continue to perform at theselevels (in addition to improvingperformance of systems that currentlymeet existing SWTR criteria but operateat turbidity levels higher than those intoday’s final rule).

Individual Filter PerformanceSeveral of the studies published since

1994, considered by both EPA and theM-DBP Advisory Committee andoutlined in the 1997 NODA, note thatthe greatest potential for a peak inturbidity (and thus, pathogen break-through) is near the beginning of thefilter run after filter backwash or startup of operation (Amirtharajah 1988;Bucklin et al. 1988; Cleasby 1990; andHall and Croll 1996). During a turbidityspike, significant amounts of particulatematter (including oocysts, if present)may pass through the filter. Variousfactors affect the duration andamplitude of filter spikes, includingsudden changes to the flow rate throughthe filter, treatment of the filterbackwash water, filter-to-wastecapability, and site-specific waterquality conditions. As discussed in the1997 IESWTR NODA, these issueshighlighted the need to ensure thatsystems have a greater understanding ofindividual filter performance and thusfor establishment of individual filtermonitoring and reporting requirements.

Turbidity MeasurementThe November 3, 1997 NODA

discussed several issues relating tomeasurement of turbidity. It was notedthat issues exist concerning theaccuracy and precision of turbiditymeasurement due to design criteria,calibration methods, calibrationstandards, and sampling technique.Performance evaluation (PE) studies

conducted by EPA provide anindication of the current level ofaccuracy and precision for turbiditymeasurements among differentlaboratories for a common syntheticallyprepared water. In PE studies, PEsamples with known turbidity levels aresent to participating laboratories (whichare not informed of the turbidity level).Laboratories participating in thesestudies used turbidimeters from variousmanufacturers and conducted theiranalysis in accordance with calibrationand analytical procedures they arefamiliar with. Thus, the variability ofthe results reflects differences resultingfrom using different turbidimetermodels and methods and the effects ofdifferent laboratory procedures. Four PEstudies were discussed in the NODAwith turbidities in the range of 0.35 to0.72 NTU. The Relative StandardDeviations (RSD) at turbidity levelsconsidered in these PE studies areslightly below 20%.

3. Summary of Major CommentsIn response to the 1994 proposal, EPA

received a range of comments both insupport of and in opposition tooptimizing existing water treatmentprocesses to address Cryptosporidiumremoval. Several commenters supportedtighter turbidity standards as well asmonitoring of individual filters. Othercommenters suggested no modificationsbe made to turbidity standards untilfurther implementation of the SWTRand/or further supporting data wasgathered.

Commenters on the 1997 NODAprovided additional views on thegeneral subject of filtration performanceand turbidity. Commenters generallysupported tightening combined filtereffluent performance standards as wellas the establishment of individual filtermonitoring requirements. EPA agreeswith these comments, as reflected intoday’s rule. EPA also notes thatturbidity performance data that reflectsimplementation of the SWTR wasanalyzed as part of the M–DBP AdvisoryCommittee discussions and wasconsidered by the Committee indeveloping the recommendations forturbidity which are reflected in today’srule.

Several commenters discussed theability of systems to measure turbidityat low levels (<0.3 NTU) with accuracyand consistency. EPA believes that theperformance evaluation (PE) studiescited in the NODA provide anindication of the precision and accuracyof turbidity measurements at low levels.While turbidities in these studies onlyranged from 0.35 to 0.72 NTU, theyprovided an understanding of the ability

to measure at such levels. EPArecognizes that accurate and consistentmeasurements are not only a function ofavailable technology but also a functionof a range of operator/technician factorsincluding calibration, maintenance,training, and adherence to manufacturerinstructions. In conjunction with theIESWTR, EPA is currently developingguidance, with stakeholder input,targeted at assisting owners/operatorswith understanding turbidity as well asfocusing on the importance of accuracyand consistency in turbiditymeasurement, including the low levelmeasurement concerns noted by thecommenters.

Many commenters discussed the issueof lime-softening plants and how thenew requirements would affect suchplants which, because of the softeningprocesses, have artificially elevatedlevels of turbidity. The IESWTR allowsacidification of samples for thecombined filter effluent at limesoftening plants. In addition, EPA isallowing systems that use lime softeningto apply to States for alternativeexceedance reporting levels forindividual filters if they candemonstrate that higher turbidity levelsin individual filters are due to limecarryover and not due to degraded filterperformance.

Several commenters noted thatspecial filters would present difficultiesin complying with the individual filtermonitoring requirements. While EPArealizes that variations exist in filterconfigurations and filters in use atsystems throughout the country, theIESWTR will not seek to address thespecific requirements of each and everyone. EPA intends to provide States theflexibility and the tools necessary toeffectively deal with special filtersdiscussed by the commenters on a moreappropriate case-by-case basis.

Another issue raised in publiccomments was the need to clarify howpublic notice requirements in theIESWTR would be integrated withfuture public notice requirements underthe SDWA. EPA notes that today’saction addresses public notification byusing the existing public notificationlanguage for microbiologicalcontaminants in 40 CFR 141.32 (e)(10)for violations of treatment techniquerequirements under the IESWTR. EPAtakes this opportunity to note that the1996 amendments to the SDWA requirethe Agency to make certain technicalchanges to the public notice regulations.EPA intends to propose changes to thepublic notice requirements in theFederal Register shortly afterpromulgation of the IESWTR.Applicable changes in the public notice


requirements, when they becomeeffective, will supersede today’sprovisions. EPA also takes thisopportunity to note that today’s ruleamends the Consumer ConfidenceReport Regulation (CCR) to extend theCCR requirements to apply to Subpart Pviolations.

Several respondents indicated that itwould be necessary to provide guidancematerials to systems to aid incompliance with these rules. EPA iscurrently developing a number ofguidance manuals, with stakeholderinput, to aid systems in understandingand complying with requirements. Onesuch manual will address issues ofturbidity control and filter performance.

D. Disinfection Benchmark for Stage 1DBPR MCLs

1. Today’s Rule

Today’s rule establishes thedisinfection benchmark as a procedurerequiring certain PWSs to evaluate theimpact on microbial risk of proposedchanges in disinfection practice. Itreflects the recommendation of the M–DBP Advisory Committee to develop amechanism that allows utilities andStates working together to assure thatpathogen control is maintained whilethe Stage 1 DBPR provisions areimplemented. In essence, this procedureinvolves a PWS charting daily levels ofGiardia lamblia inactivation for a periodof at least one year to create a profile ofinactivation performance. The PWSmust then use this profile to determinea baseline or benchmark of inactivationagainst which proposed changes indisinfection practices can be measured.However, only certain systems arerequired to develop a profile and keepit on file for State review during sanitarysurveys. When those systems requiredto develop a profile plan a significantchange in disinfection practice, theymust submit the profile, along with ananalysis of how the proposed changewill affect the current disinfectionbenchmark, to the State for review. Thedisinfection benchmark provisions,then, contain three major components:applicability requirements,characterization of disinfection practice,and State review of proposed changes indisinfection practice. Each of thesecomponents is discussed in turn below.

Applicability

Systems are required to prepare adisinfection profile if at least one of thefollowing criteria is met:

(1) TTHM levels are at least 80% ofthe MCL (0.064 mg/L) as an annualaverage

(2) Haloacetic acid (HAA5) levels areat least 80% of the MCL (0.048 mg/L) asan annual average

In connection with TTHM and HAA5monitoring to create a disinfectionprofile, the following provisions apply:

First, the TTHM annual average mustbe the annual average during the sameperiod as is used for the HAA5 annualaverage. Second, systems that havecollected TTHM and HAA5 data underthe ICR must use the results of samplescollected during the last 12 months ofmonitoring unless the State determinesthat there is a more representativeannual data set. Third, systems notrequired to collect data under the ICRbut which have collected fourconsecutive quarters of TTHM andHAA5 data that substantially meet thesample location, handling, andanalytical methods requirements of theICR may use those data if approved bythe State. (Systems must coordinatewith the State to confirm acceptabilityof the existing data). Fourth, if thesystem does not have four quarters ofacceptable HAA5 and TTHM data by theend of 90 days following the IESWTRpromulgation date, the PWS mustconduct HAA5 and TTHM monitoringto determine an annual average.Alternatively, the system may elect toconduct profiling, as described below,and forego TTHM/HAA5 monitoring todetermine applicability. Thismonitoring must be completed no laterthan 15 months after promulgation ofthis rule and conform to the monitoringlocation requirements of the 1979TTHM Rule and the analytical methodsin the May 1996 Information CollectionRule.

Today’s rule applies profilingrequirements to systems with TTHM orHAA5 concentrations of at least 80% ofthe MCL, based upon the M–DBPAdvisory Committee technicalrecommendation that this level willcover most systems that might beexpected to modify their disinfectionpractices to comply with the Stage 1DBPR. Also, EPA previously consideredthis 80% target level at therecommendation of the 1992 Reg NegCommittee to evaluate Stage 1 DBPRcompliance forecasts and costs, basedupon the judgment that most facilitieswill take additional steps to ensurecontinuing MCL compliance if they areat or above this level.

Developing the Profile and BenchmarkProfiling is the characterization of a

system’s disinfection practice over a oneyear period. The system can create theprofile by conducting new dailymonitoring and also by using‘‘grandfathered’’ data (as explained

below). A disinfection profile consists ofa compilation of daily Giardia lamblialog inactivations (plus virusinactivations for systems using eitherchloramines or ozone for primarydisinfection), computed over the periodof a year, based on daily measurementsof operational data (disinfectant residualconcentration(s), contact time(s),temperature(s), and, where necessary,pH).

Grandfathered data are thoseoperational data that a system haspreviously collected at a treatment plantduring the course of normal operation.These data may or may not have beenused previously for compliancedeterminations with the SWTR. Thosesystems that have all necessary data todetermine profiles using existingoperational data collected prior topromulgation of the IESWTR may usethese data in developing profiles.However, grandfathered data must besubstantially equivalent to operationaldata that would be collected under thisrule. These data must be representativeof inactivation through the entiretreatment plant and not just of certaintreatment segments. The Statedetermines whether grandfathered dataare acceptable. (EPA believes thatgrandfathered data used in constructingprofiles should be the most recent dataavailable, unless the State determinesthat there is a more representative data.)

Systems required to developdisinfection profiles under this rulemust exercise one of the following threeoptions:

Option 1—Systems must conductdaily monitoring as described below.This monitoring must begin no laterthan 15 months after IESWTRpromulgation and must continue for aperiod of one year. The data collectedfrom this monitoring must be used todevelop a one year disinfection profile;

Option 2—Systems that conductmonitoring under this rule, as describedunder Option 1, may also use one or twoyears of acceptable grandfathered data,in addition to the one year of newoperational data, in developing thedisinfection profile;

Option 3—Systems that have threeyears of acceptable existing operationaldata are not required to conductmonitoring to develop the disinfectionprofile under this rule. Instead, theymay use grandfathered data to developa three year disinfection profile.Systems must coordinate with the Stateto confirm acceptability ofgrandfathered data no later than 15months after promulgation of this rule,but must conduct the requiredmonitoring until the State approves thesystem’s request to use grandfathered


data. In order to develop the profile, asystem must:—Measure disinfectant residual

concentration (C, in mg/L) before or atthe first customer and just prior toeach additional point of disinfectantaddition, whether with the same or adifferent disinfectant.

—Determine contact time (T, inminutes) for each residualdisinfectant monitoring point duringpeak flow conditions. T can be basedon either a tracer study orassumptions based on contactor basingeometry and baffling. However,systems must use the same method forboth grandfathered data and new data.

—Measure water temperature (°C).—Measure pH (for chlorine only).The system must then convert dailyoperational data to daily log inactivationvalues for Giardia (and viruses whenchloramines or ozone is used forprimary disinfection) as follows:—Determine CTcalc for each

disinfection segment.—Determine CT99.9 (i.e., 3-log

inactivation) from tables in the SWTRusing temperature (and pH forchlorine) for each disinfectionsegment. Alternatively, States mayallow an alternate calculationprocedure (e.g. use of spreadsheet).

—For each segment, log inactivation =(CTcalc/CT99.9)×3.0.

—Sum the log inactivations for eachsegment to get the daily loginactivation.A log inactivation benchmark is then

calculated as follows:1. Calculate the average log

inactivation of all the days for eachcalendar month.

2. Determine the calendar month withthe lowest average log inactivation.

3. The lowest average month becomesthe critical period for that year.

4. If acceptable data from multipleyears are available, the average ofcritical periods for each year becomesthe benchmark.

5. If only one year of data is available,the critical period (lowest monthlyaverage inactivation level) for that yearis the benchmark.

State Review

If a system that is required to producea disinfection profile decides to make asignificant change in disinfectionpractice after the profile is developed, itmust consult with the State beforeimplementing such a change.Significant changes in disinfectionpractice are defined as: (1) Moving thepoint of disinfection (this is notintended to) include routine seasonalchanges already approved by the State),

(2) changing the type of disinfectant or(3) changing the disinfection process, (4)making other modifications designatedas significant by the State. Supportingmaterials for such consultation with theState must include a description of theproposed change, the disinfectionprofile developed under this rule forGiardia lamblia (and, if necessary,viruses), and an analysis of how theproposed change will affect the currentdisinfection benchmark. In addition, theState is required to review disinfectionprofiles as part of its periodic sanitarysurvey.

EPA is currently developing, withstakeholder input, the DisinfectionBenchmarking Guidance Manual forStates and systems. This manual willprovide instruction on the developmentof disinfection profiles, identificationand evaluation of significant changes indisinfection practices, andconsiderations for setting an alternativebenchmark. This manual will alsoprovide guidance for systems that arerequired to develop a profile based onvirus inactivation instead of Giardialamblia inactivation.

2. Background and AnalysisA fundamental principle of the 1992–

93 regulatory negotiation reflected inthe 1994 proposal for the IESWTR wasthat new standards for control ofdisinfection byproducts must not resultin significant increases in microbialrisk. This principle was also one of theunderlying premises of the 1997 M-DBPAdvisory Committee’s deliberations,i.e., that existing microbial protectionmust not be significantly reduced orundercut as a result of systems takingthe necessary steps to comply with theStage 1 DBPR. The Advisory Committeereached agreement on the use ofmicrobial profiling and benchmarkingas a process by which a PWS and theState, working together, assure thatthere will be no significant reduction inmicrobial protection as the result ofmodifying disinfection practices inorder to meet MCLs for TTHM andHAA5.

The strategy of disinfection profilingand benchmarking stemmed from dataprovided to the EPA and M-DBPAdvisory Committee by PWSs andreviewed by stakeholders, in which thebaseline of microbial inactivation(expressed as logs of Giardia lambliainactivation) demonstrated highvariability. Inactivation varied byseveral log on a day-to-day basis at anyparticular treatment plant and by asmuch as tens of logs over a year due tochanges in water temperature, flow rate(and, consequently, contact time),seasonal changes in residual

disinfectant, pH, and disinfectantdemand (and, consequently,disinfectant residual). There were alsodifferences between years at individualplants. To address these variations, M-DBP stakeholders developed theprocedure of profiling a plant’sinactivation levels over a period of atleast one year, and then establishing abenchmark of minimum inactivation asa way to characterize disinfectionpractice. This approach makes itpossible for a plant that may need tochange its disinfection practice in orderto meet DBP MCLs to determine theimpact the change would have on itscurrent level of disinfection and,thereby, to assure that there is nosignificant increase in microbial risk.

3. Summary of Major CommentsIn the 1997 IESWTR NODA, EPA

requested public comment on allaspects of the benchmarking procedure,along with any alternative suggestions,from stakeholders and other interestedparties. EPA specifically requestedcomment on the following issues:Applicability requirements;characterization of disinfectionpractices and components; use of TTHMand HAA5 data from the same timeperiod instead of TTHM data from oneyear and HAA5 data from another;definition of significant changes todisinfection practice; differentapproaches to evaluating possiblechanges in disinfection practice againsta disinfection profile; and whether theuse of grandfathered data, if available,should be mandatory for profiling andbenchmarking.

The majority of comments on theoverall benchmarking procedureoutlined in the 1997 IESWTR NODAwere positive. Commentersacknowledged the procedure as a way tomaintain microbial control in systemschanging their disinfection practices tocomply with DBP MCLs. However, asignificant area of concern expressed incomments was that if PWSs believe theywill be held to a relatively higherregulatory standard as a result ofmaintaining a greater level ofdisinfection than is currently required,then some PWSs may reduce loginactivation during profiling in order tolower their benchmarks. EPAemphasizes that benchmarking is notintended to function as a regulatorystandard. Rather, the objective of thedisinfection benchmark is to facilitateinteractions between the States andPWSs for the purpose of assessing theimpact on microbial risk of proposedsignificant changes to existingdisinfection practices. Final decisionsregarding levels of disinfection beyond


those required by the SWTR that arenecessary to protect public health willcontinue to be left to the States. For thisreason EPA has not mandated specificevaluation protocols or decisionmatrices for analyzing changes indisinfection practice. EPA is, however,providing support to the States inmaking these analyses through theissuance of guidance. This approach isconsistent with a majority of commentson this issue which requested that EPAnot require specific procedures for thesetting of alternative benchmarks but,rather, provide guidance to States.

Several commenters suggested thatinstead of requiring profiling andbenchmarking in regulations, EPAshould place these procedures inguidance and allow the States toimplement them at their discretion. EPAconsiders benchmarking to be animportant measure in preventingsignificant increases in microbial riskduring implementation of the M-DBPrule cluster. Moreover, States havedifferent statutory authorities governingwhat they can mandate and some Stateagencies are prohibited by State lawfrom adopting procedures not requiredby federal regulations. Consequently,EPA believes the inclusion ofbenchmarking as a regulation iswarranted.

Commenters were concerned that thebenchmarking procedure would not takeinto account source watercharacteristics and that benchmarkingwould not be accurate for systemsswitching from one disinfectant toanother (e.g. chlorine to ozone). EPAwill cover both of these topics in theDisinfection Benchmarking GuidanceManual in sections that address settingan alternative benchmark. Commentersalso asked EPA to provide instructionon awarding disinfection credits takinginto account possible synergistic effectsfor different sequential disinfectants.However, as discussed in other parts ofthis preamble, research in this area isnot adequate for a disinfection creditscheme to be developed based onsynergistic inactivation.

Most comments submitted to EPA onthe issue of applicability favored using80% of the MCLs for TTHM and HAA5as threshold levels for profiling.Commenters agreed with the EPA andM-DBP Advisory Committee that thesevalues would capture most of the PWSslikely to change their disinfectionprocesses to meet DBP MCLs. Onecommenter proposed that using TTHMand HAA5 data from two different yearswould not present a problem becauseeither one of these parameters cantrigger the profiling requirement.However, the majority of comments on

this subject supported requiring TTHMand HAA5 data to be collected duringthe same period since changes in waterquality and treatment conditionsinfluence not only the total quantity ofDBPs but also the relative formation ofdifferent DBP species. In today’s ruleEPA requires that TTHM and HAA5data used in determining applicabilitybe collected during the same period. Afew commenters recommended that theapplicability requirements for profilingshould also include ozonation systemswith bromate concentrations at least80% of the MCL (i.e. 8µg/L). EPA haselected not to include bromate levels inthe profiling requirements becauseoperational changes, such as droppingthe pH during ozonation, can decreasebromate formation without reducingdisinfection efficacy.

Certain commenters felt thatdisinfection profiling should only berequired in the event that a systemplanned to change disinfection practiceand that requiring plants which meetwater quality standards to performadditional studies is unwarranted. EPAbelieves, however, that a profile shouldspan all seasons of at least one year toshow how seasonal variations impactthe log inactivation provided.Consequently, waiting to profile until adisinfection change is needed is notpractical because at least one year ofmonitoring is required and this couldsignificantly delay the desiredmodifications. Accordingly, EPAmaintains that profiling in advance of adecision to change disinfectionpractices will allow systems to complywith TTHM and HAA5 MCLs in atimely manner without increasingmicrobial risk. For this reason, EPArequires profiling of those PWSs mostlike to modify their disinfectionprocedures (i.e. those with TTHM andHAA5 concentrations at or above 80%of the MCLs).

Many comments advocated allowingthe use of grandfathered data indeveloping disinfection profiles.However, commenters werepredominantly against making the useof existing operational data mandatory.They expressed concern that such arequirement would be inherentlyinequitable, could entail significantretrieval costs, and that the data mightnot be representative of a system’scurrent operations. EPA believes thatgrandfathered data will often providethe most accurate picture of historiclevels of microbial disinfection andencourages its use in constructing thedisinfection profile. However, EPArecognizes that certain problems, suchas those identified by commenters, mayjustify the exclusion of grandfathered

data and, therefore, has made the use ofsuch data optional. EPA notes thatStates may consider issues related toprofiling data when determiningwhether a proposed change indisinfection practice is acceptable.

The benchmarking procedure intoday’s rule, therefore, reflects theconcerns of commenters in manyrespects. On issues such as the use ofgrandfathered data, applicabilityrequirements, and evaluating proposedchanges in disinfection practice, thedisinfection benchmark requirementsconform to the majority view ofcomments. In cases where the rule is atvariance with certain commenters’suggestions, such as making thedisinfection benchmarking procedurediscretionary and requiring profilingonly in advance of a proposed change indisinfection practice, EPA has acted inaccordance with the need to achieverisk-risk balancing, which is a centralobjective of the M–DBP rule cluster.

E. Definition of Ground Water Underthe Direct Influence of Surface Water

1. Today’s Rule

In today’s rule, EPA includesCryptosporidium in the definition ofground water under the direct influenceof surface water (GWUDI). This changein definition applies only to publicwater systems that serve 10,000 or morepeople.


EPA issued guidance in October 1992as the Consensus Method forDetermining Groundwater Under theDirect Influence of Surface Water UsingMicroscopic Particulate Analysis (MPA).As part of this method, a microscopicexamination is made of the groundwater to determine whether insect parts,plant debris, rotifers, nematodes,protozoa, and other material associatedwith the surface or near surfaceenvironment are present. Additionalguidance for making GWUDIdeterminations is also available (EPA,1994d, e). Since 1990, States haveacquired substantial experience inmaking GWUDI determinations andhave documented their approaches(Massachusetts Department ofEnvironmental Protection, 1993;Maryland, 1993; Sonoma County WaterAgency, 1991). Guidance on existingpractices undertaken by States inresponse to the SWTR may also befound in the State Sanitary SurveyResource Directory, jointly published inDecember 1995 by EPA and theAssociation of State Drinking WaterAdministrators. AWWARF has also


published guidance (Wilson et al.,1996).

In the existing MPA guidance (EPA,1992), Cryptosporidia oocysts areincluded under the general category ofcoccidian protozoans, a moreencompassing grouping, some of whichare pathogenic to humans. The scoreassigned to an occurrence of a coccidianis equivalent to the score assigned to anoccurrence of a Giardia cyst. Thus, itnot anticipated that any change isneeded in the MPA scoringmethodology to accommodate theregulation of Cryptosporidium by thisrule.

The 1997 NODA summarized theavailable guidance and additionalinformation provided by the States andregulated community. Most recently,Hancock et al. (1998) summarized someof the available data on parasiticprotozoan occurrence in ground waterand EPA compiled additional data onsuch occurrence in wells (SAIC, 1997a).

3. Summary of Major Comments

The July 29, 1994, Federal Registernotice proposed to amend the SWTR byincluding Cryptosporidium in thedefinition of a GWUDI system. Underthe 1994 IESWTR proposal, a systemusing ground water consideredvulnerable to Cryptosporidiumcontamination would be subject to theprovisions of the SWTR. EPA proposedthat this determination be made by theState for individual sources using State-established criteria. The 1994 proposedIESWTR also requested comment onrevisions to EPA’s guidance on thisissue.

Commenters generally agreed thatCryptosporidium should be added to thedefinition.

F. Inclusion of Cryptosporidium inWatershed Control Requirements

1. Today’s Rule

In today’s final rule, EPA is extendingthe existing watershed controlregulatory requirements for unfilteredsystems serving 10,000 or more peopleto include the control ofCryptosporidium. Cryptosporidium willbe included in the watershed controlprovisions for these systems whereverGiardia lamblia is mentioned.


Watershed control requirements wereinitially established in 1989 (EPA,1989b, 54 FR 27496, June 29, 1989) asone of a number of preconditions that apublic water system using surface watermust meet to avoid filtration. As part ofits 1994 IESWTR proposal (EPA, 1994b,59 FR 38839, July 29, 1994), EPA

requested comment on extending theseexisting watershed control requirementsfor unfiltered systems at 40 CFR141.71(b)(2) to include the control ofCryptosporidium. This was intended tobe analogous to and build upon theexisting requirements for Giardialamblia and viruses; Cryptosporidiumwould be included in the watershedcontrol provisions wherever Giardialamblia is mentioned. In the November3, 1997 NODA (EPA, 1997a, 62 FR59506), the Agency also requestedcomment on issues pertaining tomonitoring for Giardia andCryptosporidium for unfiltered systemsserving 10,000 or more people.

As noted above, the SWTR specifiesthe conditions under which a systemcan avoid filtration (40 CFR 141.71).These conditions include good sourcewater quality, as measured byconcentrations of coliforms andturbidity; disinfection requirements;watershed control; periodic on-siteinspections; the absence of waterbornedisease outbreaks; and compliance withthe Total Coliform Rule and the MCL forTTHMs. This watershed controlprogram under the SWTR must includea characterization of the watershedhydrology characteristics, landownership, and activities which mayhave an adverse effect on source waterquality, and must minimize thepotential for source watercontamination by Giardia lamblia andviruses. The SWTR Guidance Manual(EPA, 1991a) identifies both natural andhuman-caused sources of contaminationto be controlled. These sources includewild animal populations, wastewatertreatment plants, grazing animals,feedlots, and recreational activities. TheGuidance Manual recommends thatgrazing and sewage discharges not bepermitted within the watershed ofunfiltered systems, but indicates thatthese activities may be permissible on acase-by-case basis where there is a longdetention time and a high degree ofdilution between the point of activityand the water intake. Although there areno specific monitoring requirements inthe watershed protection program, thenon-filtering utility is required todevelop State-approved techniques toeliminate or minimize the impact ofidentified point and non-point sourcesof pathogenic contamination. Theguidance already suggests identifyingsources of microbial contamination,other than Giardia, transmitted byanimals, and points out specifically thatCryptosporidium may be present if thereis grazing in the watershed.

As discussed in the 1997 IESWTRNODA, the Seattle Water Departmentsummarized the Giardia and

Cryptosporidium monitoring resultsfrom several unfiltered water systems(Montgomery Watson, 1995). Thecentral tendency of this data isapproximately 1 oocyst/100L. In light ofdata previously discussed that indicatesthat at least 2-log removal ofCryptosporidium is achievable withfiltration, and considering the Seattledata analysis, it appears that unfilteredwater systems that comply with thesource water requirements of the SWTRhave a risk of cryptosporidiosisequivalent to that of a water system witha well-operated filter plant using a watersource of average quality. EPA plans tocontinue to evaluate this issue whenadditional data becomes available.

3. Summary of Major CommentsCommenters generally supported

specific inclusion of Cryptosporidium inthe watershed control requirements forunfiltered systems. Some commenterssupported watershed control programsin general without specifically offeringan opinion on Cryptosporidium. A fewcommenters specifically opposed theinclusion of Cryptosporidium in thewatershed control program, maintainingthat other avenues of watershed controlcould be promoted without includingthis organism in the control plan andthat environmental sources of Giardiaand Cryptosporidium were notsufficiently understood.

In response, EPA believes that theenvironmental sources ofCryptosporidium are sufficientlyunderstood, as described above, tosupport rule requirements.Cryptosporidium cannot be easilycontrolled with conventionaldisinfection practices, and therefore itspresence in source water servingunfiltered surface water systems mustbe addressed. EPA also believes thatCryptosporidium poses a potentialhazard to public health and, as notedabove, is establishing in today’s rule anMCLG of zero for this pathogenicprotozoan. EPA is therefore amendingthe existing watershed controlrequirements for unfiltered systems toinclude Cryptosporidium in order toprotect public health. EPA believes thatan effective watershed protectionprogram will help to improve sourcewater quality. Existing guidance alreadyreferences the need to guard againstpathogenic protozoa includingspecifically Cryptosporidium. EPA isproceeding on the presumption thatexisting watershed programs alreadyconsider and State reviews haveevaluated the adequacy of watershedprovisions to assure that raw drinkingwater supplies are adequately protectedagainst Cryptosporidium contamination.


To the extent this is not the case,however, EPA expects that unfilteredsystems, and States in their annualreview, will reassess their program withregard to this concern and take whateversteps are necessary to ensure thatpotential vulnerability toCryptosporidium contamination isconsidered and adequately addressed.

With regard to monitoring, manyNODA commenters supported someform of routine monitoring for Giardiaand Cryptosporidium in unfilteredwatershed systems serving 10,000 ormore people. A few NODA commenterssupported event monitoring (i.e., anoccasion where the raw water turbidityand/or fecal/total coliformconcentration exceeds a specific valueor possibly a site-specific 90thpercentile value) for large unfilteredsystems while others were silent on theissue or against event monitoring. Inresponse, today’s final rule does notinclude monitoring requirements forunfiltered systems for several reasons.The IFA method is the only methodcurrently and widely available toevaluate the presence or absence ofCryptosporidium in a water supply.However, EPA does not believe thismethod is appropriate for regulatorycompliance purposes because of its lowrecovery and variability. EPA thereforebelieves that monitoring is mostappropriately handled through guidanceat this time. EPA is working withstakeholders to develop a guidancedocument for unfiltered systems whichwill describe possible monitoringprograms. Moreover, the Agency issupporting and participating in thedevelopment of improvedCryptosporidium analytical methods,including a draft interim method 1622.At the moment, it is unclear whenprototype Cryptosporidium methods(both method 1622, as well as methodsunder development to determineviability and infectivity) will beadequate for regulatory use andcompliance determinations at lowconcentration levels, but ongoingresearch appears promising in this area.As a result, establishment ofCryptosporidium monitoringrequirements for unfiltered systems willbe considered during the developmentof future microbial rules when EPA hasmore information on which to base aregulation (e.g. availability of bettermethods, ICR monitoring data, andresearch characterizing the relationshipbetween watershed control andpathogen occurrence).

G. Covered Finished Water Reservoirs

1. Today’s RuleIn today’s final rule EPA is requiring

surface water and GWUDI systems thatserve 10,000 or more people to cover allnew reservoirs, holding tanks or otherstorage facilities for finished water forwhich construction begins after theeffective date of this rule, February 16,1999. Today’s final rule does not applythese requirements to existinguncovered finished water reservoirs.

2. Background and AnalysisThe proposed IESWTR (EPA, 1994b,

59 FR 38841) indicated that EPA wasconsidering whether to issue regulationsrequiring systems to cover finishedwater reservoirs and storage tanks, andrequested public comment. TheIESWTR Notice of Data Availability(EPA, 1997a, 62 FR 59509) indicatedthat EPA was considering a requirementthat systems cover all new reservoirs,holding tanks or other storage facilitiesfor finished water for whichconstruction begins after the effectivedate of the rule and invited comment onthis issue. The IESWTR NODA alsoinvited further comment on whetherthere should be a requirement that allfinished water reservoirs, holding tanksand other storage facilities be covered aspart of the development of futureregulations.

As discussed in the 1997 IESWTRNotice of Data Availability, when afinished water reservoir is open to theatmosphere it may be subject to some ofthe environmental factors that surfacewater is subject to, depending upon site-specific characteristics and the extent ofprotection provided. Potential sourcesof contamination to uncoveredreservoirs and tanks include airbornechemicals, surface water runoff, animalcarcasses, animal or bird droppings andgrowth of algae and other aquaticorganisms due to sunlight that results inbiomass (Bailey and Lippy, 1978). Inaddition, uncovered reservoirs may besubject to contamination by personstossing items into the reservoir or illegalswimming (Pluntze 1974; Erb, 1989).Increases in algal cells, heterotrophicplate count (HPC) bacteria, turbidity,color, particle counts, biomass anddecreases in chlorine residuals havebeen reported (Pluntze, 1974, AWWACommittee Report, 1983, Silverman etal., 1983, LeChevallier et al. 1997a).

Small mammals, birds, fish, and thegrowth of algae may contribute to themicrobial degradation of an openfinished water reservoir (Graczyk et al.,1996a; Geldreich, 1990; Fayer andUngar, 1986; Current, 1986). In onestudy, sea gulls contaminated a 10

million gallon reservoir and increasedbacteriological growth, and in anotherstudy waterfowl were found to elevatecoliform levels in small recreationallakes by twenty times their normallevels (Morra, 1979). Algal growthincreases the biomass in the reservoir,which reduces dissolved oxygen andthereby increases the release of iron,manganese, and nutrients from thesediments. This, in turn, supports moregrowth (Cooke and Carlson, 1989). Inaddition, algae can cause drinking watertaste and odor problems as well asimpact water treatment processes.

EPA suggested in the proposal thatcovering reservoirs and storage tankswould reduce the potential forcontamination of the finished water bypathogens and hazardous chemicals, aswell as limit the potential for taste andodor problems and increased operationand maintenance costs resulting fromalgal blooms associated withenvironmental factors such as sunlight.Because of these concerns, EPAguidelines recommend that all finishedwater reservoirs and storage tanks becovered (EPA, 1991a,b). The AmericanWater Works Association (AWWA) alsohas issued a policy statement stronglysupporting the covering of reservoirsthat store potable water (AWWA, 1993).In addition, a survey of nine States wasconducted in the summer of 1996(Montgomery Watson, 1996). The Stateswhich were surveyed included severalin the West (Oregon, Washington,California, Idaho, Arizona, and Utah),two States in the East known to havewater systems with open reservoirs(New York and New Jersey), and onemidwestern State (Wisconsin). Seven ofthe nine States which were surveyedrequire by direct rule that all newfinished water reservoirs and tanks becovered.

EPA is currently developing, withstakeholder input, an UncoveredFinished Water Reservoir GuidanceDocument. The manual will discussmethods to maintain water quality,control aquatic and microbial growths,describe methods to cover and linereservoirs, and discuss the use ofsampling and sampling points tomonitor reservoir water quality.

3. Summary of Major CommentsMost commenters on the proposed

rule supported either federal or Staterequirements for covered finished waterreservoirs. Some commenters on theproposed rule suggested that regulationsapply only to new reservoirs while othercommenters opposed any requirement,citing high cost, the notion that ‘‘onesize does not fit all,’’ and aestheticbenefits of an open reservoir. Nearly all


the commenters on the NODAsupported regulatory requirements forcovered finished water reservoirs inorder to protect human health. Manycommenters on the NODA supportedrequirements for covered finished waterreservoirs for both new and existingreservoirs. Some commenters on theNODA supported requirements for newreservoirs only to be covered andbelieved that requirements for existinguncovered reservoirs should beincluded in a future regulation ratherthan in today’s rule. Severalcommenters on the NODA were againsta federal requirement for coveredfinished reservoirs. One commenterthought that EPA should provide Stateswith sufficient flexibility to make thefinal decision on this issue whileanother commenter suggested that anyfuture regulatory action for existingreservoirs should take the form ofguidance to States. One commenterbelieves that EPA does not have enoughinformation to require covered finishedreservoirs.

In response, EPA believes, in light ofthe substantial information summarizedabove, that microbial contaminationrisks are posed by uncovered finishedwater reservoirs and therefore isrequiring that all new reservoirs becovered. The final rule requires thatfinished water reservoirs for whichconstruction begins after the effectivedate of today’s rule be built with covers.With respect to existing reservoirs, EPAneeds more time to collect and analyzeadditional information to evaluateregulatory impacts on systems withexisting uncovered reservoirs on anational basis. EPA needs thisinformation in order to carry out thecost benefit analysis for a requirementthat existing reservoirs be covered. TheIESWTR therefore does not require thatexisting reservoirs have covers installed.EPA will further consider whether torequire the covering of existingreservoirs during the development ofsubsequent microbial regulations whenadditional data and analysis to developthe national costs of coverage areavailable.

H. Sanitary Survey Requirements

1. Today’s RuleThe State must complete sanitary

surveys for all surface water andGWUDI systems no less frequently thanevery three years for communitysystems and no less frequently thanevery five years for noncommunitysystems. The State may ‘‘grandfather’’sanitary surveys conducted afterDecember 1995 for the first set ofrequired sanitary surveys if the surveys

address the eight survey components ofthe 1995 EPA/State guidance. The rulealso provides that for communitysystems determined by the State to haveoutstanding performance based on priorsanitary surveys, successive sanitarysurveys may be conducted no lessfrequently than every five years. In itsprimacy application, the State mustinclude: (1) How it will decide whethera system has outstanding performanceand is thus eligible for sanitary surveysat a reduced frequency, and (2) how itwill decide whether a deficiencyidentified during a survey is significant.

In the IESWTR, a sanitary survey isdefined as an onsite review of the watersource (identifying sources ofcontamination using results of sourcewater assessments where available),facilities, equipment, operation,maintenance, and monitoringcompliance of a public water system toevaluate the adequacy of the system, itssources and operations and thedistribution of safe drinking water.

Components of a sanitary survey maybe completed as part of a staged orphased State review process within theestablished frequency interval set forthbelow. A sanitary survey must addresseach of the following eight elements:Source; treatment; distribution system;finished water storage; pumps, pumpfacilities, and controls; monitoring andreporting and data verification; systemmanagement and operation; andoperator compliance with Staterequirements. In addition, sanitarysurveys include review of disinfectionprofiles for systems required to complywith the disinfection benchmarkingrequirements discussed elsewhere intoday’s notice.

States must have the appropriate rulesor other authority to assure thatfacilities take the steps necessary toaddress any significant deficienciesidentified in the survey report that arewithin the control of the public watersystem and its governing body. As notedabove, a State must also, as part of itsprimary application, include how it willdecide; (1) Whether a system hasoutstanding performance and is thuseligible for sanitary surveys at a reducedfrequency, and (2) whether a deficiencyidentified during a survey is significantfor the purposes of this rule. In addition,a State must have appropriate rules orother authority to ensure that a publicwater system responds to significantdeficiencies outlined in a sanitarysurvey report within 45 days of receiptof the report, indicating how and onwhat schedule the system will addresssignificant deficiencies noted in thesurvey.

EPA notes that it will considersanitary surveys that meet IESWTRrequirements to also meet therequirements for sanitary surveys underthe Total Coliform Rule (TCR), since thedefinition of a sanitary survey under theIESWTR is broader than that for the TCR(i.e., a survey as defined under theIESWTR includes all the elements, andmore, of a sanitary survey as requiredunder the TCR). Moreover, with regardto TCR sanitary survey frequency, theIESWTR requires that surveys beconducted at least as frequently, or, insome cases, possibly more often thanrequired under the TCR.


The July 29, 1994, Federal Registerproposed to amend the SWTR to requireperiodic sanitary surveys for all publicwater systems that use surface water, orground water under the direct influenceof surface water, regardless of whetherthey filter or not. States would berequired to review the results of eachsanitary survey to determine whetherthe existing monitoring and treatmentpractices for that system are adequate,and if not, what corrective measures areneeded to provide adequate drinkingwater quality.

The July 1994 notice proposed thatonly the State or an agent approved bythe State would be able to conduct therequired sanitary survey, except in theunusual case where a State has not yetimplemented this requirement, i.e., theState had neither performed therequired sanitary survey nor generated alist of approved agents. The proposalsuggested that under exceptionalcircumstances the sanitary survey couldbe conducted by the public watersystem with a report submitted to theState within 90 days. EPA alsorequested comment on whether sanitarysurveys should be required every threeor every five years.

In 1993, the Government AccountingOffice (GAO) issued a reportsummarizing the findings of a surveyconducted to examine sanitary surveyprograms as well as GAO’s keyobservations (GAO, 1993). ‘‘On the basisof a nationwide questionnaire and areview of 200 sanitary surveysconducted in four States (Illinois,Montana, New Hampshire andTennessee), GAO found that sanitarysurveys are often deficient in how theyare conducted, documented and/orinterpreted.’’

The GAO survey found that 45 Statesomit one or more of the key elements ofsurveys that EPA recommends beevaluated. The report also indicatedthat, ‘‘regardless of a system’s size,


deficiencies previously disclosedfrequently went uncorrected.’’

In summary, GAO observed thatproblems with sanitary survey programsare compounded by the lack of anyminimum requirements on how surveysare to be conducted and documented.The GAO report notes that the result‘‘has been that a key benefit of surveys—identifying and correcting problemsbefore they become larger problemsaffecting water quality— has often notbeen realized.’’

Sanitary surveys have historicallybeen conducted by State drinking waterprograms as a preventive tool to identifywater system deficiencies that couldpose a threat to public health. Thegeneral requirements for State primacyin § 142.10(b)(2) of subpart B include aprovision that the State have asystematic program for conductingsanitary surveys for public watersystems, with priority given to thosesystems not in compliance with theState’s primary drinking waterregulations. In addition, the TCRincludes regulatory requirements forsystems to have a periodic on-sitesanitary survey (54 FR 27544–27568, 29June 1989). This rule requires allsystems that collect fewer than 5 totalcoliform samples each month toundergo such surveys. These sanitarysurveys must be conducted by the Stateor an agent approved by the State.Community water systems were to havehad the first sanitary survey conductedby June 29, 1994, and every five yearsthereafter while non-community watersystems are to have the first sanitarysurvey conducted by June 29, 1999, andevery five years thereafter unless thesystem is served by a protected anddisinfected ground water supply, inwhich case, a survey must be conductedevery 10 years. The TCR does notspecify in detail what must beaddressed in a sanitary survey or howsuch a survey should be conducted.

The SWTR does not specificallyrequire water systems to undergo asanitary survey. Instead, it requires thatunfiltered water systems, as onecriterion to remain unfiltered, have anannual on-site inspection to assess thesystem’s watershed control program anddisinfection treatment process. The on-site survey must be conducted by theState or a party approved by the State.This on-site survey is not a substitutefor a more comprehensive sanitarysurvey, but the information can be usedto supplement a full sanitary survey.

EPA’s SWTR Guidance Manual (EPA,1991a), Appendix K, suggests that, inaddition to the annual on-siteinspection, a sanitary survey beconducted every three to five years by

both filtered and unfiltered systems.This time period is suggested ‘‘since thetime and effort needed to conduct thecomprehensive survey makes itimpractical for it to be conductedannually.’’

Since the publication of the proposedESWTR and GAO report, EPA and theStates (through the Association of StateDrinking Water Authorities) have issueda joint guidance on sanitary surveysentitled EPA/State Joint Guidance onSanitary Surveys (1995). The Guidanceoutlines the following elements asintegral components of a comprehensivesanitary survey:

• Source—Protection—Physical Components and

Condition• Treatment• Distribution System• Finished Water Storage• Pumps/Pump Facilities and

Controls• Monitoring/Reporting/Data

Verification• Water System Management/

Operations• Operator Compliance with State

RequirementsThe guidance also addresses the

qualifications for sanitary surveyinspectors, the development ofassessment criteria, documentation,follow-up after the survey, tracking andenforcement.

As discussed earlier, EPA published aNODA (62 FR 59485) in November 1997discussing new information the Agencyhas received since the 1994 IESWTRproposal as well as recommendations ofthe M-DBP Advisory Committee. TheAdvisory Committee maderecommendations on the definition andfrequency of surveys, as well as onsurvey components based on the 1995EPA/State Guidance, and follow-upactivities. In the 1997 Notice, EPArequested comment on the AdvisoryCommittee recommendations. Inaddition, the Agency requestedcomment on whether systems should berequired to respond in writing to aState’s sanitary survey report. EPA alsorequested comment on (1) what wouldconstitute ‘‘outstanding performance’’for purposes of allowing sanitarysurveys for a community water systemto be conducted every five years and (2)how to define ‘‘significant deficiencies.’’

3. Summary of Major Comments

Commenters on the 1994 proposalgenerally voiced support for requiring aperiodic sanitary survey for all systems.One commenter suggested that EPAdevelop sanitary survey guidance foradministration by the States, while

another commenter suggested thatsanitary surveys by the private sector becertified by States or nationalassociations using EPA-defined criteria.Commenters recommended that surveysbe conducted either by the State or aprivate independent party/contractor.One respondent contended that sanitarysurveys, as presently conducted, wereinsufficient to assess operationaleffectiveness in surface water systems.

With regard to sanitary surveyfrequency, commenters on the 1994proposal were nearly evenly dividedbetween every three years and every fiveyears. Some commenters argued that thefrequency should depend on: (1)Whether a system’s control is effectiveor marginal, (2) system size (lessfrequent for small systems), (3) sourcewater quality, (4) whether the Statebelieves a system’s water quality islikely to change over time, (5) results ofthe previous survey, and (6) populationdensity on the watershed. Onecommenter suggested an annual sanitarysurvey.

In terms of the frequency ofconducting a sanitary survey,commenters on the 1997 noticegenerally voiced support for thefrequencies recommended by the M–DBP Advisory Committee. Onecommenter suggested that all publicwater systems should have a sanitarysurvey no less often than once everythree years and that systems withunsatisfactory or provisional ratingsshould be surveyed annually or moreoften. Another commenter suggestedthat even outstanding systems should besurveyed on a three year cycle becausepersonnel or management changes canimpact plant performance. Onerespondent recommended that sanitarysurveys be required at a maximumfrequency of every five years for allpublic water systems using surfacewater or ground water under the directinfluence of surface water as a source.One commenter suggested that threeand five year schedules be given astargets rather than requirements to allowStates flexibility in deploying resources.

EPA believes that the frequencies intoday’s rule allow States the flexibilityto prioritize and carry out the sanitarysurvey process, while also ensuring thatthese surveys will be conducted as aneffective preventive tool to identify andcorrect water system deficiencies thatcould pose a threat to public health.Given these considerations andrecognizing that there are many morenon-community than community watersystems, EPA believes that the requiredfrequencies for sanitary surveys arereasonable.


With respect to the definition ofoutstanding performance, mostcommenters on the 1997 noticesuggested some combination of both ahistory of no rule or public healthviolations and past surveys withoutsignificant deficiencies. One commentersuggested that a system with no ruleviolations in a year meeting 0.1 NTUninety-five percent of the time andpracticing filter to waste should getsome type of formal recognition fromEPA and be considered to haveoutstanding performance. Anotherrespondent pointed out that in additionto performance, other factors such asmanagement, emergency preparednessand backup structures are critical tomaintain outstanding performance.

EPA believes that today’s ruleprovides State flexibility to work withintheir existing programs in addressinghow to define outstanding performanceand significant deficiencies as part oftheir primacy application. The Agencywill discuss these issues in furtherdetail in Sanitary Survey Guidancewhich is currently under developmentwith stakeholder input.

I. Compliance Schedules

1. Today’s rule

Today’s action establishes revisedcompliance deadlines for States to adoptand for public water systems toimplement the requirements in thisrulemaking. Central to thedetermination of these deadlines are theprinciples of simultaneous compliancebetween the Stage 1 DBPR and thecorresponding rules (Interim EnhancedSurface Water Treatment Rule, LongTerm Enhanced Surface WaterTreatment Rule, and Ground WaterRule) to ensure continued microbialprotection, and minimization of risk-risk tradeoffs. These deadlines alsoreflect new legislative provisionsenacted as part of 1996 SDWAamendments. Section 1412 (b)(10) of theSDWA as amended provides PWSs mustcomply with new regulatoryrequirements 36 months afterpromulgation (unless EPA or a Statedetermines that an earlier time ispracticable or that additional time up totwo years is necessary for capitalimprovements). In addition, section1413(a)(1) provides that States have 24instead of the previous 18 months frompromulgation to adopt new drinkingwater standards.

Applying the 1996 SDWAAmendments to today’s action, thisrulemaking provides that States havetwo years from promulgation to adoptand implement the requirements of this

regulation. Simultaneous compliancewill be achieved as follows.

Subpart H water systems that serve apopulation of 10,000 or more generallyhave three years from promulgation tocomply with all requirements of thisrule, except for profiling andbenchmarking, which require systems tobegin sampling after three months. Incases where capital improvements areneeded to comply with the rule, Statesmay grant such systems up to anadditional two years to comply. Thesedeadlines were consistent with those forthe Stage 1 DBPR.

While only subpart H systems servingat least 10,000 people are affected bytoday’s rule, EPA has includedinformation on the compliancerequirements for other system categoriesfor the reader. Subpart H systems thatserve a population of less than 10,000and all ground water systems will berequired to comply with applicableStage 1 DBPR requirements within fiveyears from promulgation. Since theLong Term 1 Enhanced Surface WaterTreatment Rule (LT1) requirements thatapply to systems under 10,000 and theGround Water Rule (GWR) arescheduled to be promulgated two yearsafter today’s rule or in November 2000,the net result of this staggered deadlineis that these systems will be required tocomply with both Stage 1 DBPR andLT1/GWR requirements three years afterpromulgation of LT1/GWR at the sameend date of November 2003. For reasonsdiscussed in more detail below, EPAbelieves this is both consistent with therequirements of section 1412(b)(10) aswell as with legislative history affirmingthe Reg. Neg. objectives of simultaneouscompliance and minimization of risk-risk tradeoff.

2. Background and AnalysisThe background, factors, and

competing concerns that EPAconsidered in developing thecompliance deadlines in today’s rule areexplained in detail in both the Agency’sIESWTR and Stage 1 DBPR November1997 NODAs. As explained in thoseNODAs, EPA identified four options toimplement the requirements of the 1996SDWA Amendments. The requirementsoutlined above reflect the fourth optionthat EPA requested comment upon inNovember 1997.

By way of background, the SDWA1996 Amendments affirmed several keyprinciples underlying the M–DBPcompliance strategy developed by EPAand stakeholders as part of the 1992regulatory negotiation process. First,under section 1412(b)(5)(A), Congressrecognized the critical importance ofaddressing risk/risk tradeoffs in

establishing drinking water standardsand gave EPA the authority to take suchrisks into consideration in setting MCLor treatment technique requirements.The technical concerns and policyobjectives underlying M–DBP risk-risktradeoffs are referred to in the initialsections of today’s rule and haveremained a key consideration in EPA’sdevelopment of appropriate compliancerequirements. Second, Congressexplicitly adopted the phased M–DBPregulatory development scheduledeveloped by the NegotiatingCommittee. Section 1412(b)(2)(C)requires that the M–DBP standardsetting intervals laid out in EPA’sproposed ICR rule be maintained evenif promulgation of one of the M–DBPrules is delayed. As explained in the1997 NODA, this phased or staggeredregulatory schedule was specificallydesigned as a tool to minimize risk/risktradeoff. A central component of thisapproach was the concept of‘‘simultaneous compliance’’, whichprovides that a PWS must comply withnew microbial and DBP requirements atthe same time to assure that in meetinga set of new requirements in one area,a facility does not inadvertently increasethe risk (i.e., the risk ‘‘tradeoff’’) in theother area.

A complicating factor that EPA tookinto account in developing today’sdeadlines is that the SDWA 1996Amendments changed two statutoryprovisions that elements of the 1992Negotiated Rulemaking Agreement werebased upon. The 1994 Stage 1 DBPR andICR proposals provided that 18 monthsafter promulgation large PWS wouldcomply with the rules and States wouldadopt and implement the newrequirements. As noted above, Section1412(b)(10) of the SDWA as amendednow provides that drinking water rulesshall become effective 36 months afterpromulgation (unless the Administratordetermines that an earlier time ispracticable or that additional time forcapital improvements is necessary—upto two years). In addition, section1413(a)(1) now provides that States have24 instead of the previous 18 months toadopt new drinking water standards thathave been promulgated by EPA.

Today’s compliance deadlinerequirements reflect the principle ofsimultaneous compliance and theconcern with risk-risk tradeoffs. SubpartH systems serving a population of atleast 10,000 will be required to complywith the key provisions of this rule onthe same schedule as they will berequired to comply with the parallelrequirements of the accompanying Stage1 DBPR that is also included in today’sFederal Register.


With regard to subpart H systemsserving fewer than 10,000, EPA believesthat providing a five year complianceperiod under Stage 1 DBPR isappropriate and warranted undersection 1412(b)(10), which expresslyallows five years where necessary forcapital improvements. As discussed inmore detail in the 1997 IESWTR NODA,capital improvements require, ofnecessity, preliminary planning andevaluation. An essential prerequisite ofsuch planning is a clear understandingof final compliance requirements thatmust be met. In the case of the staggeredM–DBP regulatory schedule establishedas part of the 1996 SDWA Amendments,LT1 microbial requirements for systemsunder 10,000 are required to bepromulgated two years after the finalStage 1 DBPR. As a result, small systemswill not even know what their finalcombined compliance obligations areuntil promulgation of the LT 1 rule.Thus, an additional two year periodreflecting the two year Stage 1 DBPR/LT1 regulatory development intervalestablished by Congress is required toallow for the preliminary planning anddesign steps which are inherent in anycapital improvement process.

In the case of ground water systems,the statutory deadline for promulgationof the GWR is May 2002. However, EPAintends to promulgate this rule byNovember 2000, in order to allow threeyears for compliance and still ensuresimultaneous compliance by groundwater systems with the Stage 1 DBPRand the GWR. As in the case of subpartH systems serving fewer than 10,000,system operators will not know untilNovember 2000 what the finalcompliance requirements for both rulesare. EPA thus believes it appropriate togrant the additional two years forcompliance with the Stage 1 DBPRallowed by the statute.

EPA has been very successful inmeeting all of the new statutorydeadlines and is on track for the LT1Rule and GWR. While EPA fully intendsto meet the schedule discussed earlier,if those rules are delayed the Agencywill evaluate all available options toprotect against unacceptable risk-risktrade-offs. Part of this effort is theextensive outreach to systems alreadyunderway to fully inform water suppliesof the likely elements in the upcomingrules. In addition, EPA would considerincluding provisions for streamlinedvariance and/or exemption processingin these rules if they were delayed, inorder to enhance State flexibility inensuring that compliance with the Stage1 DBPR is not required before thecorresponding microbial protection rule.

Under today’s Stage 1 DBPR, EPA hasalready provided small subpart Hsystems and ground water systems thetwo-year extension for capitalimprovements since these systems willnot know with certainty until November2000 if capital improvements will beneeded for simultaneous compliancewith the Stage 1 DBPR and LT1/GWR.States considering whether to grant atwo-year capital improvement extensionfor compliance with the GWR or LT1will also need to consider the impact ofsuch extensions on compliance withtoday’s rule, since the two-yearextension for the Stage 1 DBPR hasalready been used. EPA believes,however, that these systems willgenerally not require extensive capitalimprovements that take longer thanthree years to install to meet Stage 1DBPR, GWR, and LT1 requirements, orwill require no capital improvements atall. However if needed, EPA will workwith States and utilities to addresssystems that require time beyondNovember 2003 to comply. This strategymay include exemptions. In addition,EPA will provide guidance andtechnical assistance to States andsystems to facilitate timely compliancewith both DBP and microbialrequirements. EPA will requestcomment on how best to do this whenthe Agency proposes the LTESWTR andGWR.

3. Summary of Major CommentsCommenters were in general

agreement that the compliance deadlinestrategy contained in the fourth optionof the 1997 NODA did the best job ofcomplying with the requirements to1996 SDWA Amendments and meetingthe objectives of the 1993 Reg. Neg.Agreement that Congress affirmed aspart of the 1996 Amendments.Nonetheless, a number of commentersexpressed concern about the ability oflarge surface water systems that had tomake capital improvements to complywith all requirements of the Stage 1DBPR and IESWTR. They pointed outthat capital improvements include morethan just the construction, but alsofinancing, design, and approval.

EPA believes that the provisions ofsection 1412(b)(10) of the SDWA asamended allow systems the flexibilityneeded to comply. As noted earlier inthis section, States may grant up to anadditional two years compliance timefor an individual system if capitalimprovements are necessary. Moreover,as both of these rules have been undernegotiation since 1992, proposed in1994 and further clarified in 1997, EPAbelieves that most systems have hadsubstantial time to consider how to

proceed with implementation and toinitiate preliminary planning. Severalcommenters also supported delaying thepromulgation of the Stage 1 DBPR forground water systems until the GWR ispromulgated, in order to ensuresimultaneous compliance with bothrules. EPA believes that this optionwould not be consistent with the reg-neg agreement, as endorsed by Congress,because the agreement specifies that theStage 1 DBPR will apply to allcommunity and nontransientnoncommunity water systems.Moreover, EPA has committed to theLT1 and GWR promulgation scheduleoutlined above precisely to address thisissue.

In conclusion EPA believes that thecompliance deadlines outlined abovefor systems covered by this rule areappropriate and consistent with therequirements of the 1996 SDWAamendments. The Agency notes,however, that some elements of Option4 outlined in the 1997 NODA apply tosystems that may be covered by futureLong Term Enhanced and Ground Waterrules. EPA intends to follow thedeadline strategy outlined in Option 4for these future rules. However, astoday’s action only relates to theIESWTR, the Agency will defer finalaction on deadlines associated withfuture rules until those rules,themselves, are finalized.

IV. State ImplementationThis section describes the regulations

and other procedures and policies Stateshave to adopt, or have in place, toimplement today’s final rule. Statesmust continue to meet all otherconditions of primacy in section 142.

Section 1413 of the SDWA establishesrequirements that a State or eligibleIndian tribe must meet to maintainprimary enforcement responsibility(primacy) for its public water systems.These include (1) adopting drinkingwater regulations that are no lessstringent than Federal NPDWRs in effectunder sections 1412(a) and 1412(b) ofthe Act, (2) adopting and implementingadequate procedures for enforcement,(3) keeping records and making reportsavailable on activities that EPA requiresby regulation, (4) issuing variances andexemptions (if allowed by the State)under conditions no less stringent thanallowed by sections 1415 and 1416, and(5) adopting and being capable ofimplementing an adequate plan for theprovision of safe drinking water underemergency situations.

40 CFR part 142 sets out the specificprogram implementation requirementsfor States to obtain primacy for thepublic water supply supervision


program, as authorized under section1413 of the Act. In addition to adoptingthe basic primacy requirements, Statesmay be required to adopt specialprimacy provisions pertaining to aspecific regulation. These regulation-specific provisions may be necessarywhere implementation of the NPDWRinvolves activities beyond those in thegeneric rule. States are required by 40CFR 142.12 to include these regulation-specific provisions in an application forapproval of their program revisions.These State primacy requirements applyto today’s final rule, along with thespecial primacy requirements discussedbelow.

To implement today’s final rule,States are required to adopt revisions to§ 141.2—definitions; § 141.32—publicnotification; § 142.14—records kept byStates; § 142.15—reports by States;§ 142.16—special primacy requirements;§ 141.52—maximum contaminant levelgoals for microbiological contaminants;§ 141.70—general requirements;§ 141.71—criteria for avoiding filtration;§ 141.73—filtration; § 141.153—contentof the reports; and a new subpart P,consisting of § 141.170 to § 141.175.

A. Special State Primacy Requirements

In addition to adopting drinking waterregulations at least as stringent as theFederal regulations listed above, EPArequires that States adopt certainadditional provisions related to thisregulation to have their programrevision application approved by EPA.This information advises the regulatedcommunity of State requirements andhelps EPA in its oversight of Stateprograms. States which require withoutexception all public water systems usinga surface water source or a ground watersource under the direct influence ofsurface water to provide filtration neednot demonstrate that the State programhas provisions that apply to systemswhich do not provide filtrationtreatment. However, such States mustprovide the text of the State statutes orregulations which specifies that publicwater systems using a source water mustprovide filtration.

EPA is currently developing, withstakeholder input, several guidancedocuments to aid the States and watersystems in implementing today’s finalrule. This includes guidance for thefollowing topics: Enhanced coagulation,disinfection benchmark and profiling,turbidity, alternative disinfectants, M–DBP simultaneous compliance, sanitarysurvey, unfiltered systems anduncovered finished water reservoirs. Inaddition, upon promulgation of theIESWTR, EPA will work with States to

develop a State implementationguidance manual.

To ensure that the State programincludes all the elements necessary fora complete enforcement program, theState’s application must include thefollowing in order to obtain EPA’sapproval for implementing this rule:

(1) Adoption of the promulgatedIESWTR.

(2) Description of how the State willimplement its sanitary survey programand how the State will assure that asystem responds in writing to a sanitarysurvey report within 45 days indicatinghow and on what schedule the systemwill address significant deficienciesnoted in the survey. The descriptionmust also identify the appropriate rulesor other authority of the State to assurethat PWSs respond to significantdeficiencies. The State must conductsanitary surveys that include eightspecified components (described below)for all surface water and GWUDIsystems no less frequently than every 3years for community systems and noless frequently than every five years fornoncommunity systems. The State may‘‘grandfather’’ sanitary surveysconducted after December 1995 for thefirst set of required sanitary surveys ifthe surveys address the eight sanitarysurvey components (source; treatment;distribution system; finished waterstorage; pumps, pump facilities andcontrols; monitoring and reporting anddata verification; system managementand operation; and operator compliancewith State requirements). Forcommunity systems determined by theState to have outstanding performancebased on prior sanitary surveys,subsequent sanitary surveys may beconducted no less than every five years.The State must include how it willdecide whether a system hasoutstanding performance in its primacyapplication. Components of a sanitarysurvey may be completed as part of astaged or phased State review processwithin the established frequency. TheState must also describe how it willdecide whether a deficiency identifiedduring a sanitary survey is significant.

(3) Description of the procedures theState will use to determine the adequacyof changes in disinfection process bysystems required to profile andbenchmark under § 141.172 and howthe State will consult with PWSs toevaluate modifications to disinfectionpractice.

(4) Description of existing or adoptionof appropriate rules or other authority toassure PWSs to conduct a CompositeCorrection Program (CCP) and to requirethat PWSs implement any follow up

recommendations that results as part ofthe CCP.

(5) Description of how the State willapprove a more representative annualdata set than the data set determinedunder § 141.172(a)(1) or (2) for thepurpose of determining applicability ofthe requirements of § 141.172(disinfection benchmarking/profiling).

(6) Description of how the State willapprove a method to calculate the logsof inactivation for viruses for a systemthat uses either chloramines or ozonefor primary disinfection.

(7) For filtration technologies otherthan conventional filtration treatment,direct filtration, slow sand filtration ordiatomaceous earth filtration, adescription of how the State willdetermine that a public water systemmay use a filtration technology if thePWS demonstrates to the State, usingpilot plant studies or other means, thatthe alternative filtration technology, incombination with the disinfectiontreatment that meets the requirements of§ 141.172(b) of this title, 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;and a description of how, for the systemthat makes this demonstration, the Statewill set turbidity performancerequirements that the system must meet95 percent of the time and that thesystem may not exceed at any time at alevel that consistently achieves 99.9percent removal and/or inactivation ofGiardia lamblia cysts, 99.99 percentremoval and/or inactivation of viruses,and 99 percent removal ofCryptosporidium oocysts.

B. State Recordkeeping RequirementsToday’s rule includes changes to the

existing record-keeping provisions toimplement the requirements in today’sfinal rule. States must maintain recordsof the following: (1) Turbiditymeasurements must be kept for not lessthan one year, (2) disinfectant residualmeasurements and other parametersnecessary to document disinfectioneffectiveness must be kept for not lessthan one year, (3) decisions made on asystem-by-system basis and case-by-casebasis under provisions of part 141,subpart H or subpart P, (4) a list ofsystems consulting with the Stateconcerning a modification ofdisinfection practice (including thestatus of the consultation), (5) a list ofdecisions that a system using alternativefiltration technologies can consistentlyachieve a 99 percent removal ofCryptosporidium oocysts as well as therequired levels of removal and/or


inactivation of Giardia and viruses forsystems using alternative filtrationtechnologies, including State-setenforceable 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, (6)a list of systems required to do filterself-assessments, CPE or CCP. Thesedecision records must be kept for 40years (as currently required by § 142.14for other State decision records) or untila subsequent determination is made,whichever is shorter.

C. State Reporting RequirementsCurrently States must report to EPA

information under 40 CFR 142.15regarding violations, variances andexemptions, enforcement actions andgeneral operations of State public watersupply programs. Today’s rule requiresStates to provide additional informationto EPA within the context of the existingspecial report requirements for theSWTR (§ 142.15(c)(1)). States mustreport a list of Subpart H systems thathave had a sanitary survey completedduring the previous year and anevaluation of the State’s program forconducting sanitary surveys.

D. Interim PrimacyOn April 28, 1998, EPA amended its

State primacy regulations at 40 CFR142.12 (EPA 1998d, 63 FR 23362) toincorporate the new process identifiedin the 1996 SDWA amendments forgranting primary enforcement authorityto States while their applications tomodify their primacy programs areunder review. The new process grantsinterim primary enforcement authorityfor a new or revised regulation duringthe period in which EPA is making adetermination with regard to primacyfor that new or revised regulation. Thisinterim enforcement authority begins onthe date of the primacy applicationsubmission or the effective date of thenew or revised State regulation,whichever is later, and ends when EPAmakes a final determination. However,this interim primacy authority is onlyavailable to a State that has primacy forevery existing national primary drinkingwater regulation in effect when the newregulation is promulgated.

As a result, States that have primacyfor every existing NPDWR already ineffect may obtain interim primacy forthis rule, beginning on the date that theState submits its complete and finalapplication for primacy for this rule toEPA, or the effective date of its revisedregulations, whichever is later. Inaddition, a State which wishes to obtaininterim primacy for future NPDWRs

must obtain primacy for this rule. Afterthe effective date of today’s rule, anyState that does not have primacy for thisrule cannot obtain interim primacy forfuture rules.

V. Economic Analysis

A. Today’s Rule

EPA has estimated that the totalannualized cost for implementing theIESWTR is $307 million, in 1998dollars, at 7 percent rate cost of capital.This estimate includes annualizedtreatment costs to utilities ($192million), start-up and annualizedmonitoring costs to utilities ($99million), and start-up and annualizedmonitoring costs to States ($16 million).Annualized treatment costs to utilitiesincludes annual operation andmaintenance costs ($106 million) andannualized capital costs assuming 7percent cost of capital ($86 million).The two cost elements which have thegreatest impact on total annualized costsare treatment ($192 million), which forthe most part reflects turbidity treatmentcosts, and turbidity monitoring ($96million). More detail including the basisfor these estimates and alternate costestimates using different cost of capitalassumptions are described later in thissection. The benefits resulting from thisrule range from $0.263 billion to $1.240billion per year using a valuation of$2,000 in health damages avoided percryptosporidiosis illness prevented(based on the mean of a distribution ofvalues ascribed to health damagesavoided, as discussed below). Based onthis analysis, EPA has determined thatthe benefits of today’s rule justify thecosts.

B. Overview of RIA for Proposed Rule

The Regulatory Impact Analysis (RIA)(EPA, 1994f) for the proposed IESWTR(59 FR 38832, July 29, 1994) onlyconsidered one of the rule options thatwere proposed: that which wouldrequire systems to provide enoughtreatment to achieve less than a 10¥4

risk level from giardiasis while meetingthe Stage 1 DBPR. Other rule optionswere not considered for the RIA becauseof insufficient data at the time ofproposal. The RIA for the proposed1994 IESWTR estimated national capitaland annualized costs (amortized capitaland annual operating costs) for surfacewater systems serving at least 10,000people at $4.4 billion and $468 million(in 1998 dollars at a 10% cost of capital)respectively. In estimating these costs, itwas assumed that additional Giardiareduction beyond the requirements ofthe SWTR to achieve the 10¥4 risk levelwould be achieved solely by using

chlorine as the disinfectant andproviding additional contact time byincreasing the disinfectant contact basinsize. Under the 1994 RIA, EPA alsoestimated that 400,000 to 500,000Giardia infections per year that could beavoided would have an economic valueof $1.4 to $1.7 billion per year (in 1998dollars at a 10% cost of capital),suggesting under this rule option, thebenefit nationwide of avoiding Giardiainfections would be as much as three orfour times greater than the estimated$468 million national annual cost ofproviding additional contact time.Development of the proposed ruleoption was based on the availability ofan analytical method to quantify Giardiasource water concentrations andprescribe appropriate levels of treatmentto achieve the 10¥4 risk level. This ruleoption was dropped from considerationof a final IESWTR since adequatemethods for measuring Giardia were notavailable during the final developmentphase of this rule. Also, ICR data wasnot available to evaluate the validity ofassumed national Giardia source waterconcentration levels under the RIA forthe proposed rule.

C. What’s Changed Since the ProposedRule

National source water occurrence datafor Giardia and Cryptosporidium arebeing collected as part of the ICR butthis data will not become available untilafter promulgation of the IESWTR.Since February 1997, the Agencyworked with stakeholders to identifyadditional data available since 1994 tosupport the RIA for the IESWTRpublished today. USEPA established theMicrobial and Disinfectants/Disinfection Byproducts AdvisoryCommittee to collect, share and analyzenew information and data, as well as tobuild consensus on the regulatoryimplications of this new information.

D. Summary of Cost AnalysisThe IESWTR will result in increased

costs to public water systems forimproved turbidity treatment,monitoring, disinfection benchmarkingand covering new finished waterreservoirs, as well as Stateimplementation costs. As discussedearlier in this Notice, the rule will onlyapply to systems using surface water orground water under the direct influenceof surface water that serve 10,000 ormore persons. (EPA notes that the ruledoes include provisions for primacyStates to conduct sanitary surveys for allsurface water and GWUDI systemsregardless of size.) EPA intends toaddress systems serving less than 10,000people, under the Long Term 1


Enhanced Surface Water TreatmentRule.

Table V.1 indicates estimated annualcosts associated with implementing theIESWTR in 1998 dollars for differentcost of capital assumptions. A cost ofcapital rate of 7 percent was used tocalculate the unit costs for the nationalcompliance cost model. This raterepresents the standard discount ratepreferred by the Office of Managementand Budget (OMB) for benefit-costanalyses of government programs andregulations. The 3 percent rate and 10percent rate are provided as a sensitivityanalysis. The 10 percent rate alsoprovides a link to the 1994 Stage 1DBPR cost analysis which was based ona 10 percent rate.

Estimated costs are presented aseither public water system (utility) orState costs. Utility costs include allcosts associated with improvedturbidity treatment, start-up and annualcosts for turbidity monitoring, the one-time cost of performing disinfectionbenchmarking, and costs for coveringnew finished water reservoirs. Statecosts include program start-up andongoing implementation costs,including sanitary surveys.

The 1994 proposal, in 1998 dollars, isequivalent to $4.370 billion for totalcapital costs, a difference of $3.611billion (in 1998 dollars) from the capitalcosts estimated for today’s final rule.The difference is accounted forprimarily by rule criteria evaluated inthe benefit-cost analysis, i.e., changes inthe level of disinfection required. Underthe final IESWTR virtually no systemswould need to install additionaldisinfection contact basins. Also, thecapital costs associated with physicalremoval under the final IESWTR aresubstantially lower than those estimatedin the 1994 RIA.

To comply with the IESWTR, systemswould be expected to employ treatmentenhancement and/or modifications.These activities were grouped into 10decision tree categories based on generalprocess descriptions as follows:chemical addition, coagulantimprovements, rapid mixing,flocculation improvements, settlingimprovements, filtration improvements,hydraulic improvements, administrationculture improvements, laboratorymodifications and process controltesting modifications. Descriptions ofhow systems were expected to evaluatethese activities are included in thedocument Technologies and Costs forthe Interim Enhanced Surface WaterTreatment Rule (USEPA, 1998b).

The decision tree stratifies publicwater systems into groups or categoriesbased on the number of people served

and the range of treatment choicesavailable to them to achievecompliance. The decision treeincorporates estimates of the percent ofpublic water systems in each categoryselecting a particular approach toachieve compliance. These percentageswere factors in the national cost modeland represent the percentage of systemsneeding to modify treatment to meet thelimits. Further description of thecompliance decision tree andmethodology are included in theRegulatory Impact Analysis for theInterim Enhanced Surface WaterTreatment Rule (USEPA, 1998a). Basedon this decision tree analysis and thetotal costs indicated in Table V.1, thetwo cost elements which have thegreatest impact on national costs areTotal Treatment, which for the mostpart reflects turbidity treatment costs,and Turbidity Monitoring. The percentof systems estimated to modifytreatment practices to meet the revisedturbidity requirements (i.e., 0.3 NTU 95percentile and 1 NTU maximumcombined filter effluent levels) is 50percent (or 691 out of a possible 1,381systems), as shown in Table V.2.Turbidity monitoring is required of allsystems covered by the rule and usingrapid granular filtration (i.e.,conventional or direct filtration). Asshown in table V.3, total annual cost toutilities for turbidity monitoring are $96million.

E. Household Costs

Household costs are a way torepresent water system treatment costsas costs to the system customer. Underthe IESWTR, households will face theincreases in annual costs displayed inFigure V.1. All households served bylarge surface water systems will incuradditional costs under the IESWTRsince all systems are required to performturbidity monitoring activities.However, as shown in the cumulativedistribution of households affected bythe rule, 92 percent of households (60million) will incur less than a cost of $1per month. 7 percent of households (5million) will face an increase in cost ofbetween $1 and $5 per month. Thehighest cost faced by 23,000 householdsis approximately $100 per year ($8 permonth).

The assumptions and structure of thisanalysis, in describing the curve, tend tooverestimate the highest costs. To be onthe upper bound of the curve, a systemwould have to implement all, or almostall, of the treatment activities. Thesesystems, however, might seek less costlyalternatives, such as connecting into alarger regional water system.

F. Summary of Benefits Analysis

The economic benefits of the IESWTRderive from the increased level ofprotection to public health. The primarygoal of these provisions is to improvepublic health by increasing the level ofprotection from exposure toCryptosporidium and other pathogens(i.e., Giardia, or other waterbornebacterial or viral pathogens) in drinkingwater supplies through improvementsin filtration at water systems. TheIESWTR is expected to reduce the levelof Cryptosporidium and other pathogencontamination in finished drinkingwater supplies through improvementsin filtration at water systems (i.e.,revised turbidity requirements). In thiscase, benefits will accrue due to thedecreased likelihood of endemicincidences of cryptosporidiosis,giardiasis and other waterborne disease,and the avoidance of resulting healthcosts. In addition to reducing theendemic disease, the provisions areexpected to reduce the likelihood of theoccurrence of Cryptosporidiumoutbreaks and their associated economiccosts, by providing a larger margin ofsafety against such outbreaks for somesystems.

The benefit analysis attempts to takeinto account some of the uncertaintiesin the analysis by estimating benefitsunder two different current treatmentassumptions and three improvedremoval assumptions. The benefitanalysis also used Monte Carlosimulations to derive a distribution ofestimates, rather than a single pointestimate.

The benefits analysis focused onestimating changes in incidence ofcryptosporidiosis that would result fromthe rule. The analysis includedestimating the baseline (pre-IESWTR)levels of exposure fromCryptosporidium in drinking water,reductions in such exposure resultingfrom treatment changes to comply withthe IESWTR, and resultant reductions ofrisk.

Baseline levels of Cryptosporidium infinished water were estimated byassuming national source wateroccurrence distribution (based on databy LeChevallier and Norton 1995) and anational distribution ofCryptosporidium removal by treatment.

In the IESWTR RIA, the following twoassumptions were made about theperformance of current treatment inremoving oocysts to estimate finishedwater Cryptosporidium concentrations.Based on treatment removal efficiencydata presented in the 1997 IESWTRNODA, EPA assumed a nationaldistribution of physical removal


efficiencies with a mean of 2.5 logs anda standard deviation of ±0.63 logs.Under this assumption, average logremoval for different plants wouldgenerally range from 1.25 logs to 3.75logs. Because the finished waterconcentrations of oocysts represent thebaseline against which improvedremoval from the IESWTR is compared,variations in the log removalassumption could have considerableimpact on the risk assessment. Toevaluate the impact of the removalassumptions on the baseline andresulting improvements, an alternativemean log removal/inactivationassumption of 3.0 logs and a standarddeviation of ±0.63 logs was also used tocalculate finished water concentrationsof Cryptosporidium. Under thisassumption average log removal fordifferent plants would generally rangefrom 1.75 to 4.25 logs.

For each of the two baselineassumptions, USEPA assumed that acertain number of plants would showlow, mid or high improved removal,depending upon factors such as watermatrix conditions, filtered waterturbidity effluent levels, and coagulanttreatment conditions. As a result, theRIA considers six scenarios thatencompass the range of endemic healthdamages avoided based on the 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 sites currently operating at thehighest filtered water turbidity levelswould show the largest improvementsor high improved removal assumption(e.g., plants now failing to meet a 0.4NTU limit would show greater removal

improvements than plants now meetinga 0.3 NTU limit).

Table V.4 indicates estimated annualbenefits associated with implementingthe IESWTR. The benefits analysisquantitatively examines endemic healthdamages avoided based on the IESWTRfor each of the six scenarios mentionedabove. For each of these scenarios, EPAcalculated the mean of the distributionof the number of illnesses avoided. Theassessment also discusses, but does notquantify, other economic benefits thatmay result from the provisions,including the avoided health damagecosts associated with reduced risk ofoutbreaks and avoided costs of avertingbehavior such as boiling water or use ofan alternative water source duringoutbreaks or periods of high turbidity.

According to the RIA performed forthe IESWTR published today, the rule isestimated to reduce the mean annualnumber of illnesses caused byCryptosporidium in water systemsimproving filtration by 110,000 to463,000 cases depending upon which ofthe six baseline and improvedCryptosporidium removal assumptionswas used. Based on these values, themean estimated annual benefits ofreducing the illnesses ranges from$0.263 billion to $1.240 billion per year.This calculation is based on a valuationof $2,000 per incidence ofcryptosporidiosis prevented which isthe mean of a distribution of valuesascribed to health damages avoided. TheRIA also indicated that the rule couldresult in a mean reduction of 14 to 64fatalities each year, depending upon thevaried baseline and improved removalassumptions. Using a mean value of$5.6 million per statistical life saved,reducing these fatalities could producebenefits in the range of $0.085 billion to$0.363 billion.

G. Comparison of Costs and Benefits

Given the costs summarized in TableV.1 and the benefits summarized inTable V.4, the IESWTR results inpositive net benefits under all threeimproved removal scenarios (low, mid,and high) assuming that currenttreatment as a national average achieves2.5 log of Cryptosporidium removal,taking into account only the value ofcost of illness avoided. Using a currentnational average treatment removalassumption of 3.0 logs, net benefits arepositive under the high and midimproved removal scenarios. Netbenefits using the 3.0 log currentremoval assumption are negative underthe low improved removal scenariousing only the value of cost of illnessavoided, however, when the value ofmortalities prevented is added into thebenefits, all scenarios have positive netbenefits at the mean.

Thus, the monetized net benefits arepositive across most of the range ofcurrent treatment assumptions,improved log removal scenarios, anddiscount rates. The benefits due to theillnesses avoided may be slightlyoverstated when aggregated withbenefits due to mortalities avoided,because the mortalities were not nettedout of the number of illnesses. Thisvalue is minimal and would not becaptured at the level of significance ofthe analysis. Several categories ofbenefits, including reducing the risk ofoutbreaks, reducing exposure to otherpathogens such as Giardia, and avoidingthe cost of averting behavior have notbeen quantified for this analysis, butcould represent substantial additionaleconomic value. In addition, theestimates for avoided costs of illness donot include the value for pain andsuffering or the risk premium.

TABLE V.1.—ANNUAL COSTS OF THE INTERIM ENHANCED SURFACE WATER TREATMENT RULE ($000S)

Final Rule (1998 dollars) 1994 Proposal

3% Cost ofCapital

7% Cost ofCapital

10% Cost ofCapital

10% Cost ofCapital

1992 dollars

10% Cost ofCapital

1998 dollars

Utility CostsUtility Treatment Capital .................................................................... $758,965 $758,965 $758,965 $3,665,568 $4,370,389

Annual CostsAnnualized Capital † .......................................................................... 65,999 85,611 103,437Annual O&M ...................................................................................... 105,943 105,943 105,943Total Treatment ................................................................................. 171,942 191,554 209,380 391,702 466,891Turbidity Monitoring ........................................................................... 95,924 95,924 95,924Turbidity Exceptions* ......................................................................... 195 195 195Disinfection Benchmarking ................................................................ 2,841 2,841 2,841

Subtotal ...................................................................................... 270,902 290,514 308,340 391,702 466,891Annualized One-Time Costs**

Turbidity Monitoring Start-Up ............................................................ 289 405 504 .................... ....................


TABLE V.1.—ANNUAL COSTS OF THE INTERIM ENHANCED SURFACE WATER TREATMENT RULE ($000S)—Continued

Final Rule (1998 dollars) 1994 Proposal

3% Cost ofCapital

7% Cost ofCapital

10% Cost ofCapital

10% Cost ofCapital

1992 dollars

10% Cost ofCapital

1998 dollars

HAA Benchmarking ........................................................................... 175 246 306 .................... ....................

Subtotal ...................................................................................... 464 651 810 .................... ....................

Total Annual Utility Costs .................................................... 271,366 291,165 309,150 .................... ....................

State Costs

Annual Costs

Turbidity Monitoring ........................................................................... 5,256 5,256 5,256 .................... ....................Turbidity Exceptions*** ...................................................................... 409 409 409 .................... ....................Sanitary Survey ................................................................................. 6,979 6,979 6,979 867 1,034Disinfection Benchmarking ................................................................ 2,789 2,789 2,789 .................... ....................

Subtotal ...................................................................................... 15,433 15,433 15,433 867 1,034

Annualized One-Time Costs**

Turbidity Monitoring Start-Up ............................................................ 27 38 48 .................... ....................Disinfection Benchmarking Start-Up ................................................. 22 30 38 .................... ....................Sanitary Survey Start-Up ................................................................... 39 55 69 .................... ....................

Subtotal ...................................................................................... 88 123 155 .................... ....................

Total Annual State Costs .................................................... 15,521 15,556 15,588 .................... ....................

Total Annual Costs .............................................................. 286,887 306,721 324,738 392,569 467,925

* Costs associated with Individual Filter Effluent Turbidity Requirements for exceptions reporting, Individual Filter Assessments.** All one-time costs are annualized over 20 years.*** Costs associated with Reporting Exceptions and Comprehensive Performance Evaluations.† Most costs are annualized over 20 years. Some costs, including turbidimeters and process control monitoring, are annualized over 7 years.

TABLE V.2.—FINAL ANNUAL COST ESTIMATES FOR TURBIDITY TREATMENT REQUIREMENTS

[0.3 NTU CFE 95th percentile, 1 NTU CFE Maximum 1998 $000s]

System Size (population served) Number ofSystems

SystemsModifyingTreatment

3 PercentCost ofCapital



10,000–25,000 .......................................................................................... 594 303 $ 33,946 $ 37,624 $40,93225,000–50,000 316 161 29,316 31,862 35,30450,000–75,000 .......................................................................................... 124 63 15,450 17,143 18,56475,000–100,000 ........................................................................................ 52 27 7,958 8,861 9,508100,000–500,000 ...................................................................................... 259 122 56,895 63,544 69,080500,000–1 Million ...................................................................................... 26 11 16,310 18,381 20,092>1 Million .................................................................................................. 10 4 10,130 11,641 12,927

Total ................................................................................................... 1,381 691 170,005 189,056 206,407

TABLE V.3.—UTILITY TURBIDITY START-UP AND MONITORING ANNUAL COSTS

Compliance Activities Respondents Affected Unit Costs CF * Annual Costs

Utility Start-Up Costs ** .............................................. 1,381 Systems ..................................... $3,108 0.09439 $405,136Utility Plant Monitoring Costs .................................... 1,728 Plants ......................................... 52,644 90,968,832Utility System Monitoring Costs ................................. 1,381 Systems ..................................... 3,588 4,955,028

Total Annual Utility Costs for Turbidity Monitor-ing and Start-Up.

......................................................... 96,328,996

* The Capitalization Factor (CF) is calculated using the cost of capital (7%), the number of years of capitalization (20 years), and the currentvalue of money ($1).

** Start-up costs are annualized over 20 years with a CF of 0.09439.


TABLE V.4.—SUMMARY OF POTENTIAL ANNUAL BENEFITS

Baseline Assumes

2.5 Log Cryptosporidium Removal 3.0 Log Cryptosporidium Removal

Mean Range Mean Range

Cryptosporidiosis IllnessAvoided Annually

Low Estimate of Number ofIllnesses Avoided.

338,000 .......................... 0–1,029,000 ................... 110,000 .......................... 0–322,500

Cost of Illness Avoided .. $0.950 billion .................. 0–1.883 billion ................ 0.263 billion .................... 0–0.585 billionMid Number of Illnesses

Avoided.432,000 .......................... 0–1,074,000 ................... 141,000 .......................... 0–333,000

Cost of Illness Avoided .. 1.172 billion .................... 0–1.960 billion ................ 0.327 billion .................... 0–0.608 billionHigh Number of Illnesses

Avoided.463,000 .......................... 0–1,080,000 ................... 152,000 .......................... 0–338,000

Cost of Illness Avoided .. 1.240 billion .................... 0–1.999 billion ................ 0.359 billion .................... 0–0.620 billion

Value of CryptosporidiosisMortalities Avoided Annually

Low Number of MortalitiesAvoided.

48 ................................... 0–129 ............................. 14 ................................... 0–40

Value of MortalitiesAvoided.

0.272 billion .................... 0–0.674 billion ................ 0.085 billion .................... 0–0.209 billion

Mid Number of MortalitiesAvoided.

60 ................................... 0–135 ............................. 18 ................................... 0–42



High Number of MortalitiesAvoided.

64 ................................... 0–136 ............................. 20 ................................... 0–42



Reduced Risk ofCryptosporidiosis Outbreaks

Cost of Illness AvoidedEmergency ExpendituresLiability Costs Benefits not quantified, but could be substantial for large outbreak ($0.800 billion cost of illness avoided for a

Milwaukee-level outbreak).Reduced Risk from Other

Pathogens.Benefits not quantified.

Enhanced Aesthetic WaterQuality.

Difference may not be noticeable to consumer.

Averting Behavior ...................... Benefits not quantified, but could be substantial for large outbreak ($0.020 billion to $0.062 billion for a Mil-waukee-level outbreak).

BILLING CODE 6560–50–P


BILLING CODE 6560–50–C

VI. Additional Issues Discussed in 1994Proposal and 1997 NODA

A. Inactivation of Cryptosporidium

When the IESWTR was proposed in1994, EPA recognized that chlorinedisinfectants were relatively ineffectivein inactivating Cryptosporidium, butwas not certain if alternativedisinfectants might be more effectivethan chlorine. In the NODA for theIESWTR, EPA discussed the presentdata on Cryptosporidium disinfectionfor a variety of disinfectants. Manycommenters thought that sufficient datawas not available to develop guidelinesfor estimating inactivation ofCryptosporidium in water. Severalcommenters pointed out theinconsistency of inactivation data fromdifferent studies. Some commenters alsosupported the use of Giardia as thetarget organism for defining thedisinfection benchmark required bytoday’s rule. EPA believes thatvariability in inactivation results is notsurprising, given the absence ofstandard testing protocol andmethodology, and agrees that theexisting data is not sufficient to enablethe development of guidelines forestimating inactivation efficiencies forCryptosporidium in water. The Agencyalso notes that research is underway tobetter clarify inactivation efficiencies forCryptosporidium and anticipates thatnew research results will be availablefor consideration during the

development of the Long Term 2Enhanced Surface Water Treatment Rulewhich EPA plans to promulgatesimultaneously with the Stage 2 DBPR.

B. Giardia Inactivation CT Values forProfiling/Benchmarking

In the 1997 NODA for the IESWTR,EPA requested comment on developingCT tables for free chlorine at pH levelsabove 9, which are not currentlyavailable in EPA’s guidance to theSWTR. This effort was intended tosupport implementation of themicrobial profiling/benchmarkingrequired in the today’s rule. Under theprofiling/benchmarking requirement,certain utilities must determine CTvalues and compute daily average loginactivation of Giardia.

While some commenters supportedthe CT tables for high pHs presented inthe NODA, other commenters opposedthem because they thought that theliterature data were not sufficient fordevelopment of these CT tables.Commenters also noted that for thesystems with pH levels higher than 9,States currently provide guidelines bywhich utilities can estimate inactivationlevels for the purpose of compliancewith the SWTR. State guidelines are touse inactivation levels at pH 9 for abovepH 9 conditions. EPA believes theseguidelines, along with existing CTtables, are sufficient for implementingthe benchmark/profiling requirementsand therefore no additional CT tableshave been developed at this time.

As explained previously, inconjunction with today’s rule, EPA isalso concurrently promulgating the

Stage 1 DBPR under which themaximum disinfectant residual level forfree chlorine is 4 mg/L. However, the CTtables for free chlorine that appear inthe SWTR Guidance Manual only coverthe chlorine residual up to 3 mg/L.Some commenters expressed a need forCT values for higher chlorine residuals.Since it has been observed that the freechlorine residual concentration (C) isnot as significant as the contact time (T)in terms of inactivation kinetics forGiardia cysts and no data are currentlyavailable to support the development ofadditional CT tables for the range ofchlorine residuals between 3 and 4 mg/L, EPA recommends that for the purposeof microbial profiling/benchmarking thevalue of 3 mg/L as Cl2 be used forestimating log inactivation when thechlorine residual level is higher than 3mg/L.

C. Cross Connection Control

Today’s Rule

EPA is not establishing requirementsfor cross connection control in today’sfinal rule. The Agency does plan toconsider cross connection control issuesduring the development of subsequentmicrobial regulations, in the context ofa broad range of issues related todistribution systems. At that time theresults of research currently in progressshould be available to the Agency andenable EPA to make regulatorydecisions.

Background and Analysis

The proposed IESWTR (EPA, 1994b,59 FR 38841, July 29, 1994) requested


public comment on whether the Agencyshould require States and/or systems tohave a cross-connection controlprogram. In addition, the Agencysolicited comment on a number ofassociated issues, including (1) whatspecific criteria, if any, should beincluded in such a requirement, (2) howoften such a program should beevaluated, (3) whether EPA should limitany requirement to only thoseconnections identified as a crossconnection by the public water systemor the State, and (4) conditions underwhich a waiver from this requirementwould be appropriate. The Agency alsorequested commenters to identify otherregulatory measures EPA shouldconsider to prevent contamination ofdrinking water in the distributionsystem (e.g., minimum pressurerequirements in the distributionsystem).

Historically, a significant portion ofwaterborne disease outbreaks reportedby CDC are caused by distributionsystem deficiencies. Distribution systemdeficiencies are defined in CDC’spublication Morbidity and MortalityWeekly Report as cross connections,contamination of water mains duringconstruction or repair, andcontamination of a storage facility.Between 1971–1994, approximately 53waterborne disease outbreaks reportedwere associated with cross connectionsor backsiphonage. Fifty-six outbreakswere associated with other distributionsystem deficiencies (Craun, Pers. Comm.1997b). Some outbreaks have resultedfrom water main breaks or repairs.

There is no centralized repositorywhere backflow incidents are reportedor recorded. The vast majority ofbackflow incidents are probably notreported. Examples of specific backflowincidents are described in detail inEPA’s Cross-Connection Control Manual(EPA, 1989a).

Where cross connections exist, someprotection is still afforded to thedistribution system by the maintenanceof a positive water pressure in thesystem. Adequate maintenance ofpressure provides a net movement ofwater out through breaks in thedistribution pipes and preventscontaminated water outside of the pipesfrom entering the drinking watersupply. The loss of pressure in thedistribution system, less than 20 psi,can cause a net movement of water fromoutside the pipe to the inside, possiblyallowing the introduction of fecalcontamination into the system. Thisproblem is of special concern wherewastewater piping is laid in the samestreet as the water pipes, creating a

potential threat to public healthwhenever there is low or no pressure.

A number of States have crossconnection control programs, althoughthe extent to which they vary is unclear.A Florida Department of EnvironmentalProtection survey evaluated cross-connection control regulations in the 50States (Florida DEP 1996). The surveyresults showed that 29 of the 40 Statesthat responded to the survey requesthave programs. The rigor of theprograms and the extent to which theyare enforced was not addressed by thesurvey. An EPA report suggests that theresponsibility for administration andenforcement of the State programs isgenerally at the local level (EPA, 1995a).

Summary of Major CommentsMost commenters supported either a

federal or State cross connection controlprogram in order to prevent diseaseoutbreaks and injury to the public.Some commenters suggested EPAupdate its guidance document on crossconnection control. Commentersopposed to a cross connection controlprogram indicated that (1) a federally-mandated program would beimpractical, burdensome, and wouldfail, (2) a State or local program wouldbe more appropriate than an EPA-mandated program, (3) most Statesalready have a comprehensive program,thus negating need for federalregulations, (4) EPA should publishgeneral guidelines only, and (5) thereshould be a separate regulation becausea cross connection control programwould affect both surface water andground water.

As noted above, EPA plans toconsider cross connection control in thecontext of future microbial rules ratherthan in the IESWTR. The Agency willconsider cross connection control issuesin connection with a broad range ofissues related to distribution systems asit develops these microbial rules. Issuesto be considered include biofilm growthand the potential for biofilm associatedwith pathogens, water treatment anddistribution system operations tominimize microbial growth, and causesof pathogen intrusion into thedistribution system. These are all areasthat are the focus of a significantresearch effort, most of which is still inprogress. The American Water WorksAssociation Research Foundation(AWWARF) presently has 17 projectspertaining to maintenance of waterquality in the distribution system thatare not yet complete. EPA’s laboratoriesare also working on important researchquestions in these areas. EPA intends toevaluate this large body of distributionsystem research as well as data on State

and local government requirements andtheir impact in order to developcomprehensive regulations andguidance on distribution systemmaintenance and operations, includingthe prevention of cross-connections.

EPA has previously publishedguidance on cross connection controlentitled the Cross Connection ControlManual (EPA, 1989a, EPA 570/9–89–007, June 1989). This guidancedescribes methods, devices, etc. forprevention of backflow and back-siphonage, testing procedures forbackflow preventers, administration ofcross-connection programs and cross-connection control ordinanceprovisions. The Agency plans to updatethis Cross Connection Control Manualduring the development of futuremicrobial rules that address crossconnection. The Agency will requestpublic comment on issues related tocross connection control at that time.EPA would also like to point out that anumber of States and local governmentshave existing cross connection controlprograms and strongly encourages Statesand local governments to implementeffective cross connection controlprograms.

D. Filter Backwash RecyclingThe SDWA Amendments of 1996

require that the EPA promulgate aregulation governing the recycle of filterbackwash water within the treatmentprocess by August 2000. The Agency iscurrently developing data and collectinginformation to consider these issues ina separate rule rather than in theIESWTR. The Agency held a publicmeeting in Denver, Colorado, in July1998 and plans to hold another meetingin early 1999 to discuss available dataand possible regulatory options, andintends to propose a rule in August of1999.

E. Certification Criteria for Water PlantOperators

The July 29, 1994 notice requestedcomment on whether the ESWTRshould define minimum certificationcriteria for surface water treatment plantoperators. Currently, the SWTR (141.70)requires such systems to be operated by‘‘qualified personnel who meet therequirements specified by the State’’.EPA is not further defining ‘‘qualified’’in the IESWTR as the operatorcertification requirements discussedbelow will address this issue. The 1996Amendments to the SDWA direct theAdministrator, EPA, in cooperation withthe States, to publish guidelines in theFederal Register specifying minimumstandards for certification andrecertification of operators of


community and nontransientnoncommunity public water systems.Draft guidelines were published in theFederal Register Friday, March 27, 1998(EPA 1998f) with a 90-day publiccomment period. Final guidelines arerequired to be published by February1999. States then have two years toadopt and implement an operatorcertification program that meets theseguidelines. After that date, if a State hasnot adopted and implemented anapproved program, the Administratormust withhold 20 percent of the fundsa State is otherwise entitled to receivein its Drinking Water State RevolvingFund (DWSRF) capitalization grantsunder section 1452 of SDWA. Questionsregarding the draft guidelines may bedirected to Jenny Jacobs (202–260–2939)or Richard Naylor (202–260–5135) ofEPA’s Office of Ground Water andDrinking Water. Their e-mail addressesare: [email protected] [email protected]. In lightof the 1996 Amendments and the draftguidelines, certification criteria neednot be included in today’s rule.

VII. Other Requirements

A. Regulatory Flexibility Act

Under the Regulatory Flexibility Act(RFA), 5 U.S.C. 601 et seq., as amendedby the Small Business RegulatoryEnforcement Fairness Act of 1996, EPAis generally required to prepare aregulatory flexibility analysis describingthe impact of the regulatory action onsmall entities as part of the rulemaking.However, under section 605(b) of theRFA, if EPA certifies that the rule willnot have a significant economic impacton a substantial number of smallentities, EPA is not required to preparea regulatory flexibility analysis.Pursuant to section 605(b) of the RFA,the Administrator certifies that this rulewill not have a significant economicimpact on a substantial number of smallentities.

The RFA authorizes use of analternative definition to that of theSmall Business Administration for asmall water utility. Throughout the1992–93 negotiated rulemaking processfor the Stage 1 DBPR and IESWTR andin the July 1994 proposals for theserules, a small public water system(PWS) was defined as a system servingfewer than 10,000 persons. Thisdefinition reflects the fact that theoriginal 1979 standard for totaltrihalomethanes applied only to systemsserving at least 10,000 people. Thedefinition thus recognizes that baselineconditions from which systems servingfewer than 10,000 people will approachdisinfection byproduct control and

simultaneous control of microbialpathogens is different than that forsystems serving 10,000 or more persons.EPA again discussed this approach tothe definition of a small system for theserules in the March 1998 Disinfectants/Disinfection Byproducts Notice of DataAvailability (63 FR 15676, March 31,1998). EPA is continuing to define‘‘small system’’ for purposes of this ruleand the Stage 1 DBPR as a system whichserves fewer than 10,000 people. TheIESWTR applies only to systems servingat least 10,000 people and accordinglydoes not have a significant economicimpact on a substantial number of smallentities. Accordingly EPA has notcompleted a regulatory flexibilityanalysis for the IESWTR or a smallentity compliance guide.

The Agency has since proposed andtaken comment on its intent to define‘‘small entity’’ as a public water systemthat serves 10,000 or fewer persons forpurposes of its regulatory flexibilityassessments under the RFA for all futuredrinking water regulations. (SeeConsumer Confidence Reports Rule, 63FR 7620, Feb. 13, 1998.) In thatproposal, the Agency discussed thebasis for its decision to use thisdefinition and to use a single definitionof small public water system whetherthe system was a ‘‘small business’’,‘‘small nonprofit organization’’, or‘‘small governmental jurisdiction.’’ EPAalso consulted with the Small BusinessAdministration on the use of thisdefinition as it relates to smallbusinesses. Subsequently, the Agencyhas used this definition in developingits regulations under the Safe DrinkingWater Act. This approach is virtuallyidentical to the approach used in theIESWTR and Stage 1 DBPR.

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 2040–0205.

The information collected as a resultof this rule will allow the States andEPA to evaluate PWS compliance withthe rule. For the first three years afterpromulgation of this rule, the majorinformation requirements pertain tomonitoring, compliance reporting andsanitary surveys. Responses to therequest for information are mandatory(Part 141). The information collected isnot confidential.

EPA is required to estimate theburden on PWS for complying with thefinal rule. Burden means the total time,effort, or financial resources expended

by persons to generate, maintain, retain,or disclose or provide information to orfor a Federal agency. This includes thetime needed to review instructions;develop, acquire, install, and utilizetechnology and systems for the purposesof collecting, 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.

EPA estimates that the annual burdenon PWS and States for reporting andrecordkeeping will be 150,557 hours.This is based on an estimate that therewill be 998 respondents per year whowill each, on average, need to provide3,803 responses and that the averageresponse will take 40 hours. The totalannual cost burden is $27,448,013. Thisincludes total annual labor costs of$4,615,791 for the following activities:reading and understanding the rule,planning, training, data collection, datareview, data reporting, recordkeeping,compliance tracking and makingdeterminations. The cost burden alsoincludes capital costs of $17,137,222 forturbidimeter installation by PWS, andan operations and maintenance cost of$5,695,000 for turbidimeters.

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 listedin 40 CFR part 9 and 48 CFR chapter 15.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. This ICR was previously subject topublic notice and comment prior toOMB approval. As a result, EPA findsthat there is ‘‘good cause’’ under section553 (b) (B) of the AdministrativeProcedures Act (5 U.S.C. 553 (b) (B) toamend this table without prior noticeand comment. Due to the technicalnature of the table, further notice andcomment would be unnecessary.

C. Unfunded Mandates Reform Act

1. Summary of UMRA requirements

Title II of the Unfunded MandatesReform Act of 1995 (UMRA), Pub. L.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 to State, local,and tribal governments, in the aggregate,or to the private sector, of $100 millionor more in any one year. Beforepromulgating an EPA rule for which awritten statement is needed, section 205of the UMRA generally requires EPA toidentify and consider a reasonablenumber of regulatory alternatives andadopt the least costly, most cost-effective or least burdensome alternativethat achieves the objectives of the rule.The provisions of section 205 do notapply when they are inconsistent withapplicable law. Moreover, section 205allows EPA to adopt an alternative otherthan the least costly, most cost effectiveor least burdensome alternative if theAdministrator publishes an explanationwhy that alternative was not adoptedwith the final rule.

Before EPA establishes any regulatoryrequirements that may significantly oruniquely affect small governments,including tribal governments, it musthave developed under section 203 of theUMRA a small government agency plan.The plan must provide for notifyingpotentially affected small governments,enabling officials of affected smallgovernments to have meaningful andtimely input in the development of EPAregulatory proposals with significantFederal intergovernmental mandates,and informing, educating and advisingsmall governments on compliance withthe regulatory requirements.

2. Written Statement for Rules WithFederal Mandates of $100 Million orMore

EPA has determined that this rulecontains a Federal mandate that mayresult in expenditures of $100 million ormore for State, local, and tribalgovernments, in the aggregate and theprivate sector in any one year.Accordingly, EPA has prepared undersection 202 of the UMRA a writtenstatement which is summarized below.The written statement addresses thefollowing areas: (a) Authorizinglegislation; (b) cost-benefit analysisincluding an analysis of the extent towhich the costs of State, local andTribal governments will be paid for bythe Federal government; (c) estimates offuture compliance costs anddisproportionate budgetary effects; (d)macro-economic effects; and (e) asummary of EPA’s consultation withState, local, and Tribal governments andtheir concerns, including a summary of

the Agency’s evaluation of thosecomments and concerns; (f)identification and consideration ofregulatory alternatives; and (g) selectionof the least costly, most cost-effective orleast burdensome alternative thatachieves the objectives of the rule. Themajor points of this written statementare summarized below. A more detaileddescription of this analysis is presentedin EPA’s Unfunded Mandates ReformAct Analysis for the IESWTR(EPA,1998c) which is included in thedocket for this rule.

a. Authorizing LegislationToday’s rule is promulgated pursuant

to (section 1412(b)(2)(C)) of the 1996amendments to the SDWA; paragraph Cof this section establishes a statutorydeadline of November 1998 topromulgate this rule. In addition, theInterim Enhanced Surface WaterTreatment Rule (IESWTR) is closelyintegrated with the Stage 1 DBPR, whichalso has a statutory deadline ofNovember 1998.

b. Cost Benefit AnalysisSection V of this preamble discusses

in detail the cost and benefits associatedwith the IESWTR. Also, the EPA’sRegulatory Impact Analysis of theInterim Enhanced Surface WaterTreatment Rule (EPA, 1998a) contains adetailed cost benefit analysis. Theanalysis includes both qualitative andmonetized benefits for improvements tohealth and safety. Because of scientificuncertainty regarding the exposureassessment and the risk assessment forCryptosporidium, the Agency calculatedpartial monetary benefit estimates forthree different scenarios (low, medium,high) of improved removal ofCryptosporidium concentrationsassuming two different levels of currentinactivation (2.5 log baseline or 3.0 logbaseline). Potential monetized annualbenefits for illness avoided associatedwith Cryptosporidium ranged from amean of $0.263 billion (3.0 log) to amean of $1.24 billion (2.5 log) for thisrule depending upon varied baselineand improved Cryptosporidium removalassumptions. The benefits fromreduction in exposure toCryptosporidium have been comparedwith the aggregate annualized costs toState, local, and tribal governments andthe private sector that totaledapproximately $307 million (annualizedat 7%).

Using a current national averagetreatment removal assumption of 3.0logs, net benefits are positive under thehigh and mid improved removalscenarios. Net benefits using the 3.0 logcurrent removal assumption are

negative near and below the meanassociated with the low improvedremoval assumption using only thevalue of cost of illness avoided;however, when the value of mortalitiesprevented is added with the benefits, allscenarios have positive net benefits atthe mean.

Thus, the monetized net benefits arepositive across most of the range ofcurrent treatment assumptions,improved log removal scenarios, anddiscount rates. The benefits due to theillnesses avoided may be slightlyoverstated because mortalities were notnetted out of the number of illnessesavoided. This value is minimal andwould not be captured at the level ofsignificance of the analysis. Otherpossible benefits considered in theanalysis but not monetized are reducingthe risk of outbreaks, reducing theexposure to other pathogens, enhancingaesthetic water quality, avoiding thecost of averting behavior, and reducingthe cost of pain and suffering. Thesebenefits could add substantial economicvalue to this rule.

Various Federal programs exist toprovide financial assistance to State,local, and Tribal governments incomplying with this rule. The Federalgovernment provides funding to Statesthat have primacy enforcementresponsibility for their drinking waterprograms through the Public WaterSystems Supervision Grants program.Additional funding is available fromother programs administered either byEPA or other Federal agencies. Theseinclude the Drinking Water StateRevolving Fund (DWSRF) and Housingand Urban Development’s CommunityDevelopment Block Grant Program.

For example, SDWA authorizes theAdministrator of the EPA to awardcapitalization grants to States, which inturn can provide low cost loans andother types of assistance to eligiblepublic water systems. The DWSRFassists public water systems withfinancing the costs of infrastructureneeded to achieve or maintaincompliance with SDWA requirements.Each State will have considerableflexibility to determine the design of itsprogram and to direct funding towardits most pressing compliance and publichealth protection needs. States mayalso, on a matching basis, use up to tenpercent of their DWSRF allotments foreach fiscal year to assist in running theState drinking water program.

c. Estimates of Future Compliance Costsand Disproportionate Budgetary Effects

EPA believes that the cost estimatesindicated above in Section V to be afairly accurate assessment of future


compliance costs and generally does notanticipate any disproportionatebudgetary effects. In general, the coststhat a public water system, whetherpublicly or privately owned, will incurto comply with this rule will depend onmany factors that are not generallybased on location. However, the dataneeded to confirm this assessment andto analyze other impacts of this problemare not available; therefore, EPA lookedat three other factors: The impacts of theregulation on small versus largesystems, the costs to public versusprivate water systems, and the costs tohouseholds. First, EPA notes that theIESWTR does not have a significantimpact on a substantial number of smallentities, as discussed previously inSection VII.A. These small systems arethe subject of a subsequent rulemakingplanned for 2000.

Second, the review of costs to publicversus private systems is based onestimates of the allocation of thesystems across size categories and canonly be viewed as an indication ofpossible impacts. More important,implementation of the rule affects bothpublic and private water systemsequally, with the variance in total costby system size merely a function of thenumber of affected systems. Thisanalysis is presented in further detail inthe IESWTR UMRA Analysis Document(EPA, 1998c).

Finally, the highest estimatedhousehold costs would be for thosehouseholds served by systems thatwould have to implement all proposedcombined filter effluent alternativetreatment activities to meet the 0.3 NTUrequirement for 95 percent of samples ina given month and a maximum of 1NTU. However, this analysis mayoverstate costs because these systemsmay choose a less costly alternativesuch as point-of-use devices, selectingalternative water sources, or connectingto a larger regional water system.

d. Macro-economic EffectsAs required under UMRA Section

202, EPA is required to estimate thepotential macro-economic effects of theregulation. Macro-economic effects tendto be measurable in nationwideeconometric models only if theeconomic impact of the regulationreaches 0.25 percent to 0.5 percent ofGross Domestic Product (GDP). In 1997,real GDP was $7,188 billion so a rulewould have to cost at least $18 billionto have a measurable effect. A regulationwith a smaller aggregate effect isunlikely to have any measurable impactunless it is highly focused on aparticular geographic region oreconomic sector. The macro-economic

effects on the national economy fromthe IESWTR should be negligible basedon the fact that the total annual costs areabout $307 million per year (at a 7percent cost of capital) and the costs arenot expected to be highly focused on aparticular geographic region or sector.

e. Summary of EPA’s Consultation WithState, Local, and Tribal Government andTheir Concerns

Under UMRA section 202, EPA is toprovide a summary of its consultationwith elected representatives (or theirdesignated authorized employees) ofaffected State, local and Tribalgovernments in this rulemaking.Although this rule was proposed beforeUMRA became a statutory requirement,EPA initiated consultations withgovernmental entities and the privatesector affected by this rule throughvarious means. This includedparticipation on a RegulatoryNegotiation Committee, chartered underthe Federal Advisory Committee Act(FACA), in 1992–93 that includedstakeholders representing State andlocal governments, public healthorganizations, public water systems,elected officials, consumer groups, andenvironmental groups.

After the amendments to SDWA in1996, the Agency initiated a secondFACA process, similarly involving abroad range of stakeholders, and heldmeetings during 1997 to address theexpedited deadline for promulgation ofthe IESWTR in November 1998. EPAestablished the M–DBP AdvisoryCommittee to collect, share, and analyzenew data reviewed since the earlier Reg.Neg. process and also to build aconsensus on the regulatoryimplications of this new information.The M–DBP Advisory Committeeestablished a technical working group toassist them with the many scientificissues surrounding this rule. TheCommittee included representativesfrom organizations such as the NationalLeague of Cities, the NationalAssociation of City and County HealthOfficials, the Association ofMetropolitan Water Agencies, theAssociation of State Drinking WaterAdministrators, and the NationalAssociation of Water Companies. Inaddition, the Agency invited the NativeAmerican Water Association toparticipate in the FACA process todevelop this rule. Although theyeventually decided not to take part, theAssociation continued to be informed ofmeetings and developments through astakeholders mailing list. Stakeholderswho participated in the FACAprocesses, as well as all other interestedmembers of the public, were invited to

comment on the proposed rule andNODA. Also, as part of the Agency’sCommunication Strategy, EPA sentcopies of the proposed rule and NODAto many stakeholders, including sixtribal associations.

In addition, the Agency notifiedgovernmental entities and the privatesector of opportunities to provide inputon this rule in the Federal Register onJuly 29, 1994 (59 FR 38832) and onNovember 3, 1997 (62 FR 59485). EPAreceived written comments fromapproximately 37 commenters on theJuly 29, 1994 notice and fromapproximately 157 commenters on theNovember 3, 1997 notice. Of the 37commenters on the 1994 proposed rule,approximately 22% were States and35% were local governments. Of the 157commenters on the 1997 Notice of DataAvailability, approximately 8% wereStates and 27% were local governments.

The public docket for this rulemakingcontains all comments received by theAgency and provides details about thenature of State and local governments’concerns. Issues addressed by State andlocal government commenters includedconcerns about the cost and feasibilityof proposed regulatory alternatives torequire treatment levels based onGiardia and/or Cryptosporidiumoccurrence in a public water system’ssource water; preferences for requiring 2log removal of Cryptosporidium forfiltered systems; and concerns about thefeasibility of requiring source watermonitoring for unfiltered systems. Anumber of commenters on the issue ofsanitary survey frequencies supportedthe three and five years frequencies forcommunity and non-community watersystems, respectively, as recommendedby the M–DBP Advisory Committee.Some State commenters, however,expressed concern about resources forcarrying out the surveys on such aschedule. On the issue of flexibility inimplementing the Stage 1 DBPR andIESWTR to ensure that the rules areimplemented simultaneously, mostcommenters preferred option four(discussed in the November 1997IESWTR NODA) that calls forsimultaneous implementation of boththe IESWTR and the Stage 1 DBPR.

EPA understands the State and localgovernment concerns noted above. EPAagrees that of the regulatory alternativesproposed, the appropriate alternative isthe 2 log removal requirement forCryptosporidium included in the finalrule; the rule does not include treatmentrequirements based on microbialoccurrence in source water. Nor does itrequire source water monitoring forunfiltered systems, based in part onconcerns about current availability of


analytical methods. With respect tosanitary survey frequencies, the finalIESWTR reflects the M–DBP AdvisoryCommittee’s recommendations,including provisions that allow States to(1) grandfather surveys done afterDecember 1995 if they address eightelements that are currently part ofexisting State/EPA guidance; (2) dosanitary surveys on a five-year insteadof a three-year schedule for communitywater systems that the State determinesto be outstanding performers; and (3)carry out survey components in a stagedor phased manner within theestablished frequency. EPA believes thatthese frequencies and associatedprovisions in the final rule allow Statesthe flexibility to prioritize and carry outthe sanitary survey process as aneffective tool to identify and correctwater system deficiencies that couldpose a threat to public health. EPAagrees that concurrent implementationof the Stage 1 DBPR and IESWTR, asdescribed in option 4 and reflected inthe final Stage 1 DBPR complianceschedules, is the most effective means ofimplementing both rules. Finally, theAgency believes that the final IESWTRwill provide public health benefits thatjustify the costs of the rule by reducingthe public’s exposure to microbialpathogens, including Cryptosporidium.EPA notes that, as discussed in SectionV. above, over 90% of affectedhouseholds will incur costs of less than$1 per month.

f. Regulatory Alternatives ConsideredAs required under section 205 of the

UMRA, EPA considered severalregulatory alternatives that developedfrom the Regulatory Negotiationprocess, M–DBP Advisory Committee,and stakeholder comments. Theseapproaches sought to improve microbialprotection and balance the risk/risktradeoff of controlling microbialpathogens while simultaneouslylimiting the formation of disinfectionbyproducts. EPA proposed corerequirements related to ground waterunder the direct influence of surfacewater, watershed control for unfilteredsystems and sanitary surveys for allsurface water systems, as well as fivetreatment alternatives for controllingpathogens, including a number of sub-options. In addition, the Agencyrequested comment on possiblesupplemental treatment requirementsfor requiring covers on finished waterreservoirs, cross connection controlprograms and State notification of highturbidity levels and other issues relatedto turbidity control. Among thesevarious approaches, the Agency wasunable to pursue certain ones in the

final IESWTR because additional datawas needed.

Additional analysis of the regulatoryalternatives was provided by the M–DBP Advisory Committee. The M–DBPAdvisory Committee assessed tighteningturbidity performance criteria andmonitoring individual filtrationperformance. The Committee discussedat least one alternative that would haverequired the use of membranetechnology to improve turbidityperformance but concluded that utilitiescould more affordably achieve sufficientperformance levels through changes inoperation and administrative practices.The Committee considered threedifferent turbidity standards as well assome existing State requirements forindividual filter monitoring. A moredetailed description of these alternativesis discussed in Chapter V of the IESWTRRegulatory Impact Analysis (EPA,1998a).

g. Selection of the Least Costly, MostCost-Effective or Least BurdensomeAlternative That Achieves theObjectives of the Rule

As discussed above, EPA consideredvarious regulatory options that wouldreduce exposures to pathogens anddisinfectant byproducts that are theobjectives of the SDWA. For instance,the M–DBP Committee analyzed thecost for three different levels of turbidityperformance for the combined filtereffluent turbidity requirements(measured in NTUs). The three NTUlimits considered at the 95th percentilewere 0.1, 0.2, and 0.3 and their costestimates show a clear distinctionamong the three different levels. At the0.1 NTU, the total annual costs oftreatment were estimated to be $3,213million. At 0.2 NTU and 0.3 NTU, thetotal annual costs of treatment wereestimated to be $317 million and $174million, respectively. The costs of the0.1 NTU requirement were roughly 20times the 0.3 NTU scenario and 10 timesthe 0.2 NTU scenario.

The large increase in costs for the 1.0NTU scenario occurs because it wasassumed that 95 percent of systemswould need to install costly membranetechnology to comply with this level.Most of the difference between the 0.2and 0.3 levels is attributable to twice asmany systems having to installcoagulant aid polymer feed and filteraid polymer feed capabilities incomplying with the 0.2 NTU limit ascompared with the 0.3 NTU limit. TheCommittee recommended the 0.3 optionbecause they felt that this level wouldprovide adequate health protection atthe least cost. The 0.3 NTU limit wasthe option that was eventually adopted

as part of this rule and is the least costlyoption that accomplishes the objectivesof the IESWTR.

3. Impacts on Small GovernmentsEPA has determined that this rule

contains no regulatory requirements thatmight significantly or uniquely effectsmall governments. Thus this rule is notsubject to the requirements of section203 of UMRA. For purposes of theIESWTR, EPA has defined small publicwater systems as those that serve apopulation of fewer than 10,000, asdiscussed above in Section VIIA.Consequently, section 203 of UMRAdoes not apply because, as discussedabove, the IESWTR applies to systemsserving 10,000 or more people. As notedabove, EPA plans to address surfacewater systems serving fewer than 10,000people in the Long Term 1 EnhancedSurface Water Treatment Rule.

Even though section 203 does notapply, the FACA processes gave avariety of stakeholders, including smallgovernments, the opportunity for timelyand meaningful participation in theregulatory development process. Groupssuch as the National Association of Cityand County Health Officials and theNational League of Cities participated inthe rule making process. Through suchparticipation and exchange, EPAnotified small governments ofrequirements under consideration andprovided officials of these smallgovernments with an opportunity tohave meaningful and timely input intothe development of regulatoryproposals.

D. National Technology Transfer andAdvancement Act

Under section 12(d) of the NationalTechnology Transfer and AdvancementAct (‘‘ANTTAA’’), the Agency isrequired 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, businesspractices, etc.) that are developed oradopted by voluntary consensusstandards bodies. Where available andpotentially applicable voluntaryconsensus standards are not used byEPA, the Act requires the Agency toprovide Congress, through the Office ofManagement and Budget, anexplanation of the reasons for not usingsuch standards.

Today’s rule requires the use ofpreviously approved technicalstandards for the measurement ofturbidity. In previous rulemakings, EPA


approved three methods for measuringturbidity in drinking water. Turbidity isa method-defined parameter andtherefore modifications to any of thethree approved methods requires priorEPA approval. One of the approvedmethods was published by the StandardMethods Committee of American PublicHealth Association, the American WaterWorks Association, and the WaterEnvironment Federation, a voluntaryconsensus standard body. That method,Method 2130B is published in StandardMethods for the Examination of Waterand Wastewater (19th ed.). StandardMethods is a widely used referencewhich has been peer-reviewedthroughout the scientific community. Inaddition to this voluntary consensusstandard, EPA approved Great LakesInstrument Method 2 as an alternate testprocedure for the measurement ofturbidity. Finally, the Agency approveda revised EPA Method 180.1 forturbidity measurement in August 1993in Methods for the Determination ofInorganic Substances in EnvironmentalSamples (EPA–600/R–93–100).

In 1994, EPA reviewed and rejectedan additional technical standard for themeasurement of turbidity, the ISO 7027standard, which measures turbidity at ahigher wavelength than the approvedtest measurement standards. The ISO7027 is an analytical method for themeasurement of turbidity. ISO 7027measures turbidity using either 90°scattered or transmitted light dependingon the turbidity concentrationevaluated. Although instrumentsconforming to ISO 7027 specificationsare similar to the GLI instrument, onlythe GLI instrument uses pulsed,multiple detectors to simultaneouslyread both 90° scattered and transmittedlight. EPA has no data upon which toevaluate whether the separate 90°scattered or transmitted lightmeasurement evaluations according tothe ISO 7027 method would produceresults that are equivalent to resultsproduced using GLI Method 2, StandardMethod 2130B, or EPA Method 180.1.

Today’s final rule also requirescontinuous individual filter monitoringfor turbidity and requires PWSs tocalibrate the individual turbidimeteraccording to the turbidimetermanufacturer’s instructions. Thesecalibration instructions may constitutetechnical standards as that term isdefined in the NTTAA. EPA has lookedfor voluntary consensus standards withregard to calibration of turbidimeter.The American Society for Testing andMaterials (ASTM) is developing suchvoluntary consensus standards;however, there do not appear to be any

voluntary consensus standards availableat this time.

E. Executive Order 12866, RegulatoryPlanning and Review

Under Executive Order 12866, (58 FR51,735 (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, or 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 ExecutiveOrder 12866, it has been determinedthat this rule is a ‘‘significant regulatoryaction’’ because it will have an annualeffect on the economy of $100 millionor more. 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 (59 FR 7629)establishes a Federal policy forincorporating environmental justice intoFederal agency missions by directingagencies to identify and addressdisproportionately high and adversehuman health or environmental effectsof its programs, policies, and activitieson minority and low-incomepopulations. The Agency hasconsidered environmental justicerelated issues concerning the potentialimpacts of this action and has consultedwith minority and low-incomestakeholders.

Three aspects of today’s rule complywith the Environmental JusticeExecutive Order and they can beclassified as follows: (1) The overallnature of the rule; (2) the inclusion ofsensitive sub-populations in theregulatory development process; and (3)the convening of a stakeholder meeting

specifically to address environmentaljustice issues. The IESWTR appliesuniformly to all surface water andGWUDI systems that serve a populationof at least 10,000 and consequently, thehealth protection benefits this ruleprovides are equal across all income andminority groups within thesecommunities. A complementaryregulation is under development thatwill address similar issues for systemsserving fewer than 10,000 people.

In addition, concerns of the sensitivesub-populations were included in theIESWTR through the Reg. Neg. and M-DBP Advisory Committee processundertaken to craft the regulation. BothCommittees were chartered under theFACA authorization, and included abroad cross-section of regulators,regulated communities, industry, publicinterest groups, and State and localpublic health officials. Representativesof sensitive sub-populations, inparticular people with AIDS,participated in the regulatorydevelopment process. Extensivediscussion on setting treatmentrequirements that provide the maximumfeasible protection took place, and thefinal consensus that resulted in the ruleconsidered issues of affordability,equity, and safety.

Finally, as part of EPA’sresponsibilities to comply with E.O.12898, the Agency held a stakeholdermeeting on March 12, 1998 (EPA 1998e)to address various components ofpending drinking water regulations; andhow they 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 eleven cities.This meeting was a continuation ofstakeholder meetings that started in1995 to obtain input on the Agency’sDrinking Water Programs. The majorobjectives for the March 12, 1998 (EPA1998e) meeting were:

• Solicit ideas from EnvironmentalJustice (EJ) stakeholders on knownissues concerning current drinkingwater regulatory efforts;

• Identify key issues of concern to EJstakeholders; and

• Receive suggestions from EJstakeholders concerning ways toincrease representation of EJcommunities in OGWDW regulatoryefforts.In addition, EPA developed a plain-English guide specifically for this


meeting to assist stakeholders inunderstanding the multiple andsometimes complex issues surroundingdrinking water regulation.

Overall, EPA believes this rule willequally protect the health of all minorityand low income populations withincommunities served by public watersystems regulated under this rule.

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

Executive Order 13045 (62 FR 19885,April 23, 1997) applies to any ruleinitiated after April 21, 1997, orproposed after April 21, 1998, that (1) isdetermined to be ‘‘economicallysignificant’’ as defined under E.O. 12866and (2) concerns an environmentalhealth or safety risk that EPA has reasonto believe may have a disproportionateeffect on children. If the regulatoryaction meets both criteria, the Agencymust evaluate the environmental healthor safety effects of the planned rule onchildren, and explain why the plannedregulation is preferable to otherpotentially effective and reasonablyfeasible alternatives considered by theAgency.

The final rule is not subject to theExecutive Order because EPA publisheda notice of proposed rulemaking beforeApril 21, 1998. However, EPA’s policysince November 1, 1995, is toconsistently and explicitly considerrisks to infants and children in all riskassessments generated during itsdecision making process including thesetting of standards to protect publichealth and the environment.

In promulgating the IESWTR theAgency recognizes that the health risksassociated with exposure to theprotozoan Cryptosporidium are ofparticular concern for certain sensitivesubpopulations, including children andimmunocompromised individuals.These concerns were considered as partof the regulatory development process,particularly in the establishment of theMCLG for Cryptosporidium in drinkingwater, and are reflected in the final rule.The IESWTR establishes a MaximumContaminant Level Goal (MCLG) of zerofor Cryptosporidium at the genus level,taking into account the need to protectsensitive populations (e.g., children)and providing for an adequate margin ofsafety. For public water systems that usesurface water, filter and serve at least10,000 people, the Agency isestablishing physical removal treatmentrequirements for Cryptosporidium. Forsystems that use conventional or directfiltration, the Agency is strengtheningthe existing turbidity standards forfinished water and is also requiring

individual filter monitoring to assist incontrolling pathogen breakthroughduring the treatment process.

H. Executive Order 12875: Enhancingthe Intergovernmental Partnership

Under Executive Order 12875, EPAmay not issue a regulation that is notrequired by statute and that creates amandate upon a State, local or tribalgovernment, unless the Federalgovernment provides the fundsnecessary to pay the direct compliancecosts incurred by those governments, orEPA consults with those governments. IfEPA complies by consulting, ExecutiveOrder 12875 requires EPA to provide tothe Office of Management and Budget adescription of the extent of EPA’s priorconsultation with representatives ofaffected State, local and tribalgovernments, the nature of theirconcerns, copies of any writtencommunications from the governments,and a statement supporting the need toissue the regulation. In addition,Executive Order 12875 requires EPA todevelop an effective process permittingelected officials and otherrepresentatives of State, local and tribalgovernments ‘‘to provide meaningfuland timely input in the development ofregulatory proposals containingsignificant unfunded mandates.’’

EPA has concluded that this rule willcreate a mandate on State, local, andtribal governments and that the Federalgovernment will not provide all of thefunds necessary to pay the direct costsincurred by the State, local, and tribalgovernments in complying with themandate. In developing this rule, EPAconsulted with State and localgovernments to enable them to providemeaningful and timely input in thedevelopment of this rule. EPA alsoinvited the Native American WaterAssociation to participate in the FACAprocess to develop this rule. Althoughthey decided not to take part in thedeliberations, the Association continuedto be informed of meetings anddevelopments through a stakeholdersmailing list.

As described above in Section VII.C.2(e), EPA held extensive meetingswith a variety of State and localrepresentatives who providedmeaningful and timely input in thedevelopment of the proposed rule. Stateand local representatives were part ofthe FACA committees involved in thedevelopment of this rule. Summaries ofthe meetings have been included in thepublic docket for this rulemaking. Seesection VII.C.2(e) for summaries of theextent of EPA’s consultation with State,local, and tribal governments; the natureof the government concerns; and EPA’s

position supporting the need to issuethe rule.

I. Executive Order 13084: Consultationand Coordination With Indian TribalGovernments

Under Executive Order 13084, EPAmay not issue a regulation that is notrequired by statute, that significantly oruniquely affects the communities ofIndian tribal governments, and thatimposes substantial direct compliancecosts on those communities, unless theFederal government provides the fundsnecessary to pay the direct compliancecosts incurred by the tribalgovernments, or EPA consults withthose governments. If EPA complies byconsulting, Executive Order 13084requires EPA to provide to the Office ofManagement and Budget, in a separatelyidentified section of the preamble to therule, a description of the extent of EPA’sprior consultation with representativesof affected tribal governments, asummary of the nature of their concerns,and a statement supporting the need toissue the regulation. In addition,Executive Order 13084 requires EPA todevelop an effective process permittingelected officials and otherrepresentatives of Indian tribalgovernments ‘‘to provide meaningfuland timely input in the development ofregulatory policies on matters thatsignificantly or uniquely affect theircommunities.’’

Today’s rule does not significantly oruniquely affect the communities ofIndian tribal governments. There arevery few Tribal surface water systemsthat serve 10,000 or more people.Moreover, the rule does not imposerequirements on the Tribal systems thatdiffer from those required for otherwater systems covered under the rule.Accordingly, the requirements ofsection 3(b) of Executive Order 13084do not apply to this rule.

J. Consultation With the ScienceAdvisory Board, National DrinkingWater Council, and Secretary of Healthand Human Services

In accordance with section 1412(d)and (e) of SDWA, EPA consulted withthe Science Advisory Board, NationalDrinking Water Council, and Secretaryof Health and Human Services, andrequested and considered theircomments in developing this rule.

K. Likely Effect of Compliance With theIESWTR 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 shall


include an analysis of the likely effectof compliance with the regulation onthe technical, financial, and managerialcapacity of public water systems. Thefollowing analysis has been performedto fulfill this statutory obligation.

Overall water system capacity isdefined in EPA guidance (EPA 816–R–98–006) (EPA 1998g) as the ability toplan for, achieve, and maintaincompliance with applicable drinkingwater standards. Capacity has threecomponents: technical, managerial, andfinancial.

Technical capacity is the physical andoperational ability of a water system tomeet SDWA requirements. Technicalcapacity refers to the physicalinfrastructure of the water system,including the adequacy of source waterand the adequacy of treatment, storage,and distribution infrastructure. It alsorefers to the ability of system personnelto adequately operate and maintain thesystem and to otherwise implementrequisite technical knowledge. A watersystem’s technical capacity can bedetermined by examining key issuesand questions, including:

• Source water adequacy. Does thesystem have a reliable source ofdrinking water? Is the source ofgenerally good quality and adequatelyprotected?

• Infrastructure adequacy. Can thesystem provide water that meets SDWAstandards? What is the condition of itsinfrastructure, including well(s) orsource water intakes, treatment, storage,and distribution? What is theinfrastructure’s life expectancy? Doesthe system have a capital improvementplan?

• Technical knowledge andimplementation. Is the system’s operatorcertified? Does the operator havesufficient technical knowledge ofapplicable standards? Can the operatoreffectively implement this technicalknowledge? Does the operatorunderstand the system’s technical andoperational characteristics? Does thesystem have an effective operation andmaintenance program?

Managerial capacity is the ability of awater system to conduct its affairs in amanner enabling the system to achieveand maintain compliance with SDWArequirements. Managerial capacity refersto the system’s institutional andadministrative capabilities.

Managerial capacity can be assessedthrough key issues and questions,including:

• Ownership accountability. Are thesystem owner(s) clearly identified? Canthey be held accountable for the system?

• Staffing and organization. Are thesystem operator(s) and manager(s)

clearly identified? Is the systemproperly organized and staffed? Dopersonnel understand the managementaspects of regulatory requirements andsystem operations? Do they haveadequate expertise to manage watersystem operations? Do personnel havethe necessary licenses andcertifications?

• Effective external linkages. Does thesystem interact well with customers,regulators, and other entities? Is thesystem aware of available externalresources, such as technical andfinancial assistance?

Financial capacity is a water system’sability to acquire and manage sufficientfinancial resources to allow the systemto achieve and maintain compliancewith SDWA requirements.

Financial capacity can be assessedthrough key issues and questions,including:

• Revenue sufficiency. Do revenuescover costs? Are water rates and chargesadequate to cover the cost of water?

• Credit worthiness. Is the systemfinancially healthy? Does it have accessto capital through public or privatesources?

• Fiscal management and controls.Are adequate books and recordsmaintained? Are appropriate budgeting,accounting, and financial planningmethods used? Does the system manageits revenues effectively?

1,381 systems are affected by theIESWTR. Of these, 691 may need tomodify their treatment process andundertake turbidity monitoring, andwill need to meet the disinfectionbenchmarking and turbidity exceptionsreporting requirements. The other 690systems will need to do turbiditymonitoring and will need to meet thedisinfection benchmarking and turbidityexceptions reporting requirements asapplicable, but will not need to modifytheir treatment process.

Systems not modifying treatment willneed to do turbidity monitoring,disinfection benchmarking, andturbidity exceptions reporting, Thesesystems are not generally expected torequire significantly increasedtechnical, financial, or managerialcapacity to comply with these newrequirements. Some individual facilitiesmay have weaknesses in one or more ofthese areas, but overall surface watersystems should have or be able to easilyobtain the capacity needed for theseactivities.

Systems needing to modify treatmentwill employ one or more of a variety ofsteps. The steps expected to beemployed by 25% or more of systems invirtually all size categories covered bythe rule are: install backwash water

polymer feed capability; installindividual filter turbidimeters; accountfor recycle flow in process controldecisions; implement a policy andcommitment to lower water qualitygoals; utilize alternative process controltesting equipment; modify/implementprocess control monitoring and control;and designate a process control strategyfacilitator.

Furthermore, there are a number ofactions that are expected to be takendisproportionately by the smaller sizedsystems covered under the IESWTR(that is to say, a greater percentage ofsmaller sized systems will undertakethese activities than will larger sizedsystems). These steps include:Structural and mechanical rapid miximprovements; filter underdrainretrofits and gravel media; filter rate-of-flow controller replacement; hydraulicimprovements in flow distribution/control/measurement; increase plantstaffing; replace obsolete bench topturbidimeters; purchase jar testapparatus; and train staff to understandprocess control strategy.

For many systems serving between10,000 and 100,000 persons which needto make treatment modifications anenhancement of technical, financial,and managerial capacity may likely beneeded. As the preceding paragraphmakes clear, these systems will bemaking structural improvements andenhancing laboratory and staff capacity.Larger sized systems have typicallyalready made these improvements aspart of normal operations. Meeting therequirements of the IESWTR willrequire operating at a higher level ofsophistication and in a better state ofrepair than some plants in the 10,000–100,000 person size category haveconsidered acceptable in the past.

Certainly there will be exceptionsboth between 10,000 and 100,000persons and above. Some larger plantsare expected to find that their technical,managerial, and financial capacityneeds to be upgraded to support thesystem in meeting the newrequirements. Likewise, some plantsserving 10,000–100,000 persons willalready have more than adequatetechnical, financial, and managerialcapacity to meet these requirements.However, in general, the systemsserving 10,000–100,000 persons needingto make treatment modifications will bethe ones most needing to enhance theircapacity.

L. Submission to Congress and theGeneral Accounting Office

The Congressional Review Act, 5U.S.C. 801 et seq., as added by the SmallBusiness Regulatory Enforcement


Fairness 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 rule is a ‘‘major rule’’ as defined by5 U.S.C. 804(2). This rule will beeffective February 16, 1999.

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List of Subjects

40 CFR Parts 9Reporting and recordkeeping

requirements.

40 CFR Parts 141 and 142Drinking water, Environmental

protection, Public utilities, Reportingand recordkeeping requirements,Reservoirs, Utilities, Water supply,Watersheds.

Dated: November 30, 1998.Carol M. Browner,Administrator.

For the reasons set out 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; E.O. 11735, 38 FR 21243, 3 CFR,1971–1975 Comp. p. 973; 42 U.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, 1857 et seq., 6901–6992k, 7401–7671q, 7542, 9601–9657, 11023,11048.

2. In § 9.1 the table is amended byadding under the indicated heading thenew entries in numerical order to readas follows:

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

40 CFR citation OMB controlno.

* * * * *

National Primary Drinking WaterRegulations

* * * * *141.170 ................................. 2040–0205141.172 ................................. 2040–0205141.174–141.175 .................. 2040–0205

* * * * *

PART 141—National Primary DrinkingWater 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 definition of ‘‘ground waterunder the direct influence of surfacewater’’ and adding the followingdefinitions in alphabetical order to readas follows:

§ 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. Forpurposes of compliance with subpart Pof 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 ofdaily Giardia lamblia inactivationthrough the treatment plant. Theprocedure for developing a disinfectionprofile is contained in § 141.172.* * * * *

Filter profile is a graphicalrepresentation of individual filterperformance, based on continuousturbidity measurements or total particlecounts versus time for an entire filterrun, from startup to backwashinclusively, that includes an assessmentof filter performance while another filteris being backwashed.* * * * *

Ground water under the directinfluence of surface water means anywater beneath the surface of the groundwith significant occurrence of insects orother macroorganisms, algae, or large-diameter pathogens such as Giardialamblia or (for subpart H systemsserving at least 10,000 people only)Cryptosporidium, or significant andrelatively rapid shifts in watercharacteristics such as turbidity,temperature, conductivity, or pH which

closely correlate to climatological orsurface water conditions. Directinfluence must be determined forindividual sources in accordance withcriteria established by the State. TheState determination of direct influencemay be based on site-specificmeasurements of water quality and/ordocumentation of well constructioncharacteristics and geology with fieldevaluation.* * * * *

Uncovered finished water storagefacility is a tank, reservoir, or otherfacility used to store water that willundergo no further treatment exceptresidual disinfection and is open to theatmosphere.* * * * *

5. Section 141.32 is amended byrevising paragraph (e)(10) to read asfollows:

§ 141.32 Public notification.

* * * * *(e) * * *(10) Microbiological contaminants (for

use when there is a violation of thetreatment technique requirements forfiltration and disinfection in subpart Hor subpart P of this part). The UnitedStates Environmental Protection Agency(EPA) sets drinking water standards andhas determined that the presence ofmicrobiological contaminants are ahealth concern at certain levels ofexposure. If water is inadequatelytreated, microbiological contaminants inthat water may cause disease. Diseasesymptoms may include diarrhea,cramps, nausea, and possibly jaundice,and any associated headaches andfatigue. These symptoms, however, arenot just associated with disease-causingorganisms in drinking water, but alsomay be caused by a number of factorsother than your drinking water. EPA hasset enforceable requirements for treatingdrinking water to reduce the risk ofthese adverse health effects. Treatmentsuch as filtering and disinfecting thewater removes or destroysmicrobiological contaminants. Drinkingwater which is treated to meet EPArequirements is associated with little tonone of this risk and should beconsidered safe.* * * * *

6. In § 141.52, the table is amended byadding a new entry, in numerical order,to read as follows:

§ 141.52 Maximum contaminant level goalsfor microbiological contaminants.

* * * * *


Contaminant MCLG

* * * * *(5) Cryptosporidium ......................... zero.

7. Section 141.70 is amended byadding paragraph (d) to read as follows:

§ 141.70 General requirements.* * * * *

(d) Additional requirements forsystems serving at least 10,000 people.In addition to complying withrequirements in this subpart, systemsserving at least 10,000 people must alsocomply with the requirements insubpart P of this part.

8. Section 141.71 is amended byrevising paragraph (b)(6) to read asfollows:

§ 141.71 Criteria for avoiding filtration.* * * * *

(b) * * *(6) The public water system must

comply with the requirements fortrihalomethanes in §§ 141.12 and 141.30until December 17, 2001. AfterDecember 17, 2001, the system mustcomply with the requirements for totaltrihalomethanes, haloacetic acids (five),bromate, chlorite, chlorine,chloramines, and chlorine dioxide insubpart L of this part.* * * * *

9. Section 141.73 is amended byadding paragraph (a)(3) and revisingparagraph (d) to read as follows:

§ 141.73 Filtration.* * * * *

(a) * * *(3) Beginning December 17, 2001,

systems serving at least 10,000 peoplemust meet the turbidity requirements in§ 141.173(a).* * * * *

(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 December 17, 2001, systemsserving at least 10,000 people must meetthe requirements for other filtrationtechnologies in § 141.173(b).

10. 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: The highest singlemeasurement and the lowest monthlypercentage of samples meeting theturbidity limits specified in §§ 141.73 or141.173 for the filtration technologybeing used. * * ** * * * *

11. Part 141 is amended by adding anew subpart P to read as follows:

Subpart P—Enhanced Filtration andDisinfectionSec.141.170 General requirements.141.171 Criteria for avoiding filtration.141.172 Disinfection profiling and

benchmarking.141.173 Filtration.141.174 Filtration sampling requirements.141.175 Reporting and recordkeeping

requirements.

§ 141.170 General requirements.(a) The requirements of this subpart P

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 requirements of thissubpart are applicable to subpart Hsystems serving at least 10,000 people,beginning December 17, 2001 unlessotherwise specified in this subpart. Theregulations in this subpart establish orextend treatment techniquerequirements in lieu of maximumcontaminant levels for the followingcontaminants: Giardia lamblia, viruses,heterotrophic plate count bacteria,Legionella, Cryptosporidium, andturbidity. Each subpart H system servingat least 10,000 people must providetreatment of its source water thatcomplies with these treatmenttechnique requirements and are inaddition to those identified in § 141.70.The treatment technique requirementsconsist of installing and properlyoperating water treatment processeswhich reliably achieve:

(1) 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.

(2) Compliance with the profiling andbenchmark requirements under theprovisions of § 141.172.

(b) A public water system subject tothe requirements of this subpart is

considered to be in compliance with therequirements of paragraph (a) of thissection if:

(1) It meets the requirements foravoiding filtration in §§ 141.71 and141.171 and the disinfectionrequirements in §§ 141.72 and 141.172;or

(2) It meets the applicable filtrationrequirements in either § 141.73 or§ 141.173 and the disinfectionrequirements in §§ 141.72 and 141.172.

(c) Systems are not permitted to beginconstruction of uncovered finishedwater storage facilities beginningFebruary 16, 1999.

§ 141.171 Criteria for avoiding filtration.

In addition to the requirements of§ 141.71, a public water system subjectto the requirements of this subpart thatdoes not provide filtration must meet allof the conditions of paragraphs (a) and(b) of this section.

(a) Site-specific conditions. Inaddition to site-specific conditions in§ 141.71(b), systems must maintain thewatershed control program under§ 141.71(b)(2) to minimize the potentialfor contamination by Cryptosporidiumoocysts in the source water. Thewatershed control program must, forCryptosporidium:

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

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

(b) During the onsite inspectionconducted under the provisions of§ 141.71(b)(3), the State must determinewhether the watershed control programestablished under § 141.71(b)(2) isadequate to limit potentialcontamination by Cryptosporidiumoocysts. The adequacy of the programmust be based on thecomprehensiveness of the watershedreview; the effectiveness of the system’sprogram to monitor and controldetrimental activities occurring in thewatershed; and the extent to which thewater system has maximized landownership and/or controlled land usewithin the watershed.

§ 141.172 Disinfection profiling andbenchmarking.

(a) Determination of systems requiredto profile. A public water system subjectto the requirements of this subpart mustdetermine its TTHM annual averageusing the procedure in paragraph (a)(1)of this section and its HAA5 annualaverage using the procedure in


paragraph (a)(2) of this section. Theannual average is the arithmetic averageof the quarterly averages of fourconsecutive quarters of monitoring.

(1) The TTHM annual average must bethe annual average during the sameperiod as is used for the HAA5 annualaverage.

(i) Those systems that collected dataunder the provisions of subpart M(Information Collection Rule) must usethe results of the samples collectedduring the last four quarters of requiredmonitoring under § 141.142.

(ii) Those systems that use‘‘grandfathered’’ HAA5 occurrence datathat meet the provisions of paragraph(a)(2)(ii) of this section must use TTHMdata collected at the same time underthe provisions of §§ 141.12 and 141.30.

(iii) Those systems that use HAA5occurrence data that meet the provisionsof paragraph (a)(2)(iii)(A) of this sectionmust use TTHM data collected at thesame time under the provisions of§§ 141.12 and 141.30.

(2) The HAA5 annual average must bethe annual average during the sameperiod as is used for the TTHM annualaverage.

(i) Those systems that collected dataunder the provisions of subpart M(Information Collection Rule) must usethe results of the samples collectedduring the last four quarters of requiredmonitoring under § 141.142.

(ii) Those systems that have collectedfour quarters of HAA5 occurrence datathat meets the routine monitoringsample number and locationrequirements for TTHM in §§ 141.12and 141.30 and handling and analyticalmethod requirements of § 141.142(b)(1)may use those data to determinewhether the requirements of this sectionapply.

(iii) Those systems that have notcollected four quarters of HAA5occurrence data that meets theprovisions of either paragraph (a)(2)(i)or (ii) of this section by March 16, 1999must either:

(A) Conduct monitoring for HAA5that meets the routine monitoringsample number and locationrequirements for TTHM in §§ 141.12and 141.30 and handling and analyticalmethod requirements of § 141.142(b)(1)to determine the HAA5 annual averageand whether the requirements ofparagraph (b) of this section apply. Thismonitoring must be completed so thatthe applicability determination can bemade no later than March 16, 2000, or

(B) Comply with all other provisionsof this section as if the HAA5monitoring had been conducted and theresults required compliance withparagraph (b) of this section.

(3) The system may request that theState approve a more representativeannual data set than the data setdetermined under paragraph (a)(1) or (2)of this section for the purpose ofdetermining applicability of therequirements of this section.

(4) The State may require that asystem use a more representative annualdata set than the data set determinedunder paragraph (a)(1) or (2) of thissection for the purpose of determiningapplicability of the requirements of thissection.

(5) The system must submit data tothe State on the schedule in paragraphs(a)(5)(i) through (v) of this section.

(i) Those systems that collectedTTHM and HAA5 data under theprovisions of subpart M (InformationCollection Rule), as required byparagraphs (a)(1)(i) and (a)(2)(i) of thissection, must submit the results of thesamples collected during the last 12months of required monitoring under§ 141.142 not later than December 16,1999.

(ii) Those systems that have collectedfour consecutive quarters of HAA5occurrence data that meets the routinemonitoring sample number and locationfor TTHM in §§ 141.12 and 141.30 andhandling and analytical methodrequirements of § 141.142(b)(1), asallowed by paragraphs (a)(1)(ii) and(a)(2)(ii) of this section, must submitthose data to the State not later thanApril 16, 1999. Until the State hasapproved the data, the system mustconduct monitoring for HAA5 using themonitoring requirements specifiedunder paragraph (a)(2)(iii) of thissection.

(iii) Those systems that conductmonitoring for HAA5 using themonitoring requirements specified byparagraphs (a)(1)(iii) and (a)(2)(iii)(A) ofthis section, must submit TTHM andHAA5 data not later than March 16,2000.

(iv) Those systems that elect tocomply with all other provisions of thissection as if the HAA5 monitoring hadbeen conducted and the results requiredcompliance with this section, asallowed under paragraphs (a)(2)(iii)(B)of this section, must notify the State inwriting of their election not later thanDecember 16, 1999.

(v) If the system elects to request thatthe State approve a more representativeannual data set than the data setdetermined under paragraph (a)(2)(i) ofthis section, the system must submitthis request in writing not later thanDecember 16, 1999.

(6) Any system having either a TTHMannual average ≥0.064 mg/L or an HAA5annual average ≥0.048 mg/L during the

period identified in paragraphs (a)(1)and (2) of this section must comply withparagraph (b) of this section.

(b) Disinfection profiling. (1) Anysystem that meets the criteria inparagraph (a)(6) of this section mustdevelop a disinfection profile of itsdisinfection practice for a period of upto three years.

(2) The system must monitor daily fora period of 12 consecutive calendarmonths to determine the total logs ofinactivation for each day of operation,based on the CT99.9 values in Tables1.1–1.6, 2.1, and 3.1 of § 141.74(b), asappropriate, through the entiretreatment plant. This system must beginthis monitoring not later than March 16,2000. As a minimum, the system witha single point of disinfectant applicationprior to entrance to the distributionsystem must conduct the monitoring inparagraphs (b)(2)(i) through (iv) of thissection. A system with more than onepoint of disinfectant application mustconduct the monitoring in paragraphs(b)(2)(i) through (iv) of this section foreach disinfection segment. The systemmust monitor the parameters necessaryto determine the total inactivation ratio,using analytical methods in § 141.74(a),as follows:

(i) The temperature of the disinfectedwater must be measured once per day ateach residual disinfectant concentrationsampling point during peak hourly flow.

(ii) If the system uses chlorine, the pHof the disinfected water must bemeasured once per day at each chlorineresidual disinfectant concentrationsampling point during peak hourly flow.

(iii) The disinfectant contact time(s)(‘‘T’’) must be determined for each dayduring peak hourly flow.

(iv) The residual disinfectantconcentration(s) (‘‘C’’) of the waterbefore or at the first customer and priorto each additional point of disinfectionmust be measured each day during peakhourly flow.

(3) In lieu of the monitoringconducted under the provisions ofparagraph (b)(2) of this section todevelop the disinfection profile, thesystem may elect to meet therequirements of paragraph (b)(3)(i) ofthis section. In addition to themonitoring conducted under theprovisions of paragraph (b)(2) of thissection to develop the disinfectionprofile, the system may elect to meet therequirements of paragraph (b)(3)(ii) ofthis section.

(i) A PWS that has three years ofexisting operational data may submitthose data, a profile generated usingthose data, and a request that the Stateapprove use of those data in lieu ofmonitoring under the provisions of


paragraph (b)(2) of this section not laterthan March 16, 2000. The State mustdetermine whether these operationaldata are substantially equivalent to datacollected under the provisions ofparagraph (b)(2) of this section. Thesedata must also be representative ofGiardia lamblia inactivation through theentire treatment plant and not just ofcertain treatment segments. Until theState approves this request, the systemis required to conduct monitoring underthe provisions of paragraph (b)(2) of thissection.

(ii) In addition to the disinfectionprofile generated under paragraph (b)(2)of this section, a PWS that has existingoperational data may use those data todevelop a disinfection profile foradditional years. Such systems may usethese additional yearly disinfectionprofiles to develop a benchmark underthe provisions of paragraph (c) of thissection. The State must determinewhether these operational data aresubstantially equivalent to datacollected under the provisions ofparagraph (b)(2) of this section. Thesedata must also be representative ofinactivation through the entiretreatment plant and not just of certaintreatment segments.

(4) The system must calculate thetotal inactivation ratio as follows:

(i) If the system uses only one pointof disinfectant application, the systemmay determine the total inactivationratio for the disinfection segment basedon either of the methods in paragraph(b)(4)(i)(A) or (b)(4)(i)(B) of this section.

(A) Determine one inactivation ratio(CTcalc/CT99.9) before or at the firstcustomer during peak hourly flow.

(B) Determine successive CTcalc/CT99.9 values, representing sequentialinactivation ratios, between the point ofdisinfectant application and a pointbefore or at the first customer duringpeak hourly flow. Under thisalternative, the system must calculatethe total inactivation ratio bydetermining (CTcalc/CT99.9) for eachsequence and then adding the (CTcalc/CT99.9) values together to determine (Σ(CTcalc/CT99.9)).

(ii) If the system uses more than onepoint of disinfectant application beforethe first customer, the system mustdetermine the CT value of eachdisinfection segment immediately priorto the next point of disinfectantapplication, or for the final segment,before or at the first customer, duringpeak hourly flow. The (CTcalc/CT99.9)value of each segment and ((CTcalc/CT99.9)) must be calculated using themethod in paragraph (b)(4)(i) of thissection.

(iii) The system must determine thetotal logs of inactivation by multiplyingthe value calculated in paragraph(b)(4)(i) or (ii) of this section by 3.0.

(5) A system that uses eitherchloramines or ozone for primarydisinfection must also calculate the logsof inactivation for viruses using amethod approved by the State.

(6) The system must retaindisinfection profile data in graphicform, as a spreadsheet, or in some otherformat acceptable to the State for reviewas part of sanitary surveys conducted bythe State.

(c) Disinfection benchmarking. (1)Any system required to develop adisinfection profile under the provisionsof paragraphs (a) and (b) of this sectionand that decides to make a significantchange to its disinfection practice mustconsult with the State prior to makingsuch change. Significant changes todisinfection practice are:

(i) Changes to the point ofdisinfection;

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

(iii) Changes to the disinfectionprocess; and

(iv) Any other modification identifiedby the State.

(2) Any system that is modifying itsdisinfection practice must calculate itsdisinfection benchmark using theprocedure specified in paragraphs(c)(2)(i) through (ii) of this section.

(i) For each year of profiling datacollected and calculated underparagraph (b) of this section, the systemmust determine the lowest averagemonthly Giardia lamblia inactivation ineach year of profiling data. The systemmust determine the average Giardialamblia inactivation for each calendarmonth for each year of profiling data bydividing the sum of daily Giardialamblia of inactivation by the number ofvalues calculated for that month.

(ii) The disinfection benchmark is thelowest monthly average value (forsystems with one year of profiling data)or average of lowest monthly averagevalues (for systems with more than oneyear of profiling data) of the monthlylogs of Giardia lamblia inactivation ineach year of profiling data.

(3) A system that uses eitherchloramines or ozone for primarydisinfection must also calculate thedisinfection benchmark for virusesusing a method approved by the State.

(4) The system must submitinformation in paragraphs (c)(4)(i)through (iii) of this section to the Stateas part of its consultation process.

(i) A description of the proposedchange;

(ii) The disinfection profile forGiardia lamblia (and, if necessary,viruses) under paragraph (b) of thissection and benchmark as required byparagraph (c)(2) of this section; and

(iii) An analysis of how the proposedchange will affect the current levels ofdisinfection.

§ 141.173 Filtration.

A public water system subject to therequirements of this subpart that doesnot meet all of the criteria in thissubpart and subpart H of this part foravoiding filtration must providetreatment consisting of bothdisinfection, as specified in § 141.72(b),and filtration treatment which complieswith the requirements of paragraph (a)or (b) of this section or § 141.73 (b) or(c) by December 17, 2001.

(a) Conventional filtration treatmentor direct filtration. (1) For systems usingconventional filtration or directfiltration, the turbidity level ofrepresentative samples of a system’sfiltered water must be less than or equalto 0.3 NTU in at least 95 percent of themeasurements taken each month,measured as specified in § 141.74(a) and(c).

(2) The turbidity level ofrepresentative samples of a system’sfiltered water must at no time exceed 1NTU, measured as specified in§ 141.74(a) and (c).

(3) A system that uses lime softeningmay acidify representative samplesprior to analysis using a protocolapproved by the State.

(b) Filtration technologies other thanconventional filtration treatment, directfiltration, slow sand filtration, ordiatomaceous earth filtration. A publicwater system may use a filtrationtechnology not listed in paragraph (a) ofthis section or in § 141.73(b) or (c) 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,and 99 percent removal ofCryptosporidium oocysts, and the Stateapproves the use of the filtrationtechnology. For each approval, the Statewill set turbidity performancerequirements that the system must meetat least 95 percent of the time and thatthe system may not exceed at any timeat a level that consistently achieves 99.9percent removal and/or inactivation ofGiardia lamblia cysts, 99.99 percentremoval and/or inactivation of viruses,


and 99 percent removal ofCryptosporidium oocysts.

§ 141.174 Filtration samplingrequirements.

(a) Monitoring requirements forsystems using filtration treatment. Inaddition to monitoring required by§ 141.74, a public water system subjectto the requirements of this subpart thatprovides conventional filtrationtreatment or direct filtration mustconduct continuous monitoring ofturbidity for each individual filter usingan approved method in § 141.74(a) andmust calibrate turbidimeters using theprocedure specified by themanufacturer. Systems must record theresults of individual filter monitoringevery 15 minutes.

(b) If there is a failure in thecontinuous turbidity monitoringequipment, the system must conductgrab sampling every four hours in lieuof continuous monitoring, but for nomore than five working days followingthe failure of the equipment.

§ 141.175 Reporting and recordkeepingrequirements.

In addition to the reporting andrecordkeeping requirements in § 141.75,a public water system subject to therequirements of this subpart thatprovides conventional filtrationtreatment or direct filtration must reportmonthly to the State the informationspecified in paragraphs (a) and (b) ofthis section beginning December 17,2001. In addition to the reporting andrecordkeeping requirements in § 141.75,a public water system subject to therequirements of this subpart thatprovides filtration approved under§ 141.173(b) must report monthly to theState the information specified inparagraph (a) of this section beginningDecember 17, 2001. The reporting inparagraph (a) of this section is in lieu ofthe reporting specified in § 141.75(b)(1).

(a) Turbidity measurements asrequired by § 141.173 must be reportedwithin 10 days after the end of eachmonth the system serves water to thepublic. Information that must bereported includes:

(1) The total number of filtered waterturbidity measurements taken duringthe month.

(2) The number and percentage offiltered water turbidity measurementstaken during the month which are lessthan or equal to the turbidity limitsspecified in § 141.173(a) or (b).

(3) The date and value of anyturbidity measurements taken duringthe month which exceed 1 NTU forsystems using conventional filtrationtreatment or direct filtration, or which

exceed the maximum level set by theState under § 141.173(b).

(b) Systems must maintain the resultsof individual filter monitoring takenunder § 141.174 for at least three years.Systems must report that they haveconducted individual filter turbiditymonitoring under § 141.174 within 10days after the end of each month thesystem serves water to the public.Systems must report individual filterturbidity measurement results takenunder § 141.174 within 10 days after theend of each month the system serveswater to the public only ifmeasurements demonstrate one or moreof the conditions in paragraphs (b)(1)through (4) of this section. Systems thatuse lime softening may apply to theState for alternative exceedance levelsfor the levels specified in paragraphs(b)(1) through (4) of this section if theycan demonstrate that higher turbiditylevels in individual filters are due tolime carryover only and not due todegraded filter performance.

(1) For any individual filter that hasa measured turbidity level of greaterthan 1.0 NTU in two consecutivemeasurements taken 15 minutes apart,the system must report the filternumber, the turbidity measurement, andthe date(s) on which the exceedanceoccurred. In addition, the system musteither produce a filter profile for thefilter within 7 days of the exceedance (ifthe system is not able to identify anobvious reason for the abnormal filterperformance) and report that the profilehas been produced or report the obviousreason for the exceedance.

(2) For any individual filter that hasa measured turbidity level of greaterthan 0.5 NTU in two consecutivemeasurements taken 15 minutes apart atthe end of the first four hours ofcontinuous filter operation after thefilter has been backwashed or otherwisetaken offline, the system must report thefilter number, the turbidity, and thedate(s) on which the exceedanceoccurred. In addition, the system musteither produce a filter profile for thefilter within 7 days of the exceedance (ifthe system is not able to identify anobvious reason for the abnormal filterperformance) and report that the profilehas been produced or report the obviousreason for the exceedance.

(3) For any individual filter that hasa measured turbidity level of greaterthan 1.0 NTU in two consecutivemeasurements taken 15 minutes apart atany time in each of three consecutivemonths, the system must report thefilter number, the turbiditymeasurement, and the date(s) on whichthe exceedance occurred. In addition,the system must conduct a self-

assessment of the filter within 14 daysof the exceedance and report that theself-assessment was conducted. The selfassessment must consist of at least thefollowing components: assessment offilter performance; development of afilter profile; identification andprioritization of factors limiting filterperformance; assessment of theapplicability of corrections; andpreparation of a filter self-assessmentreport.

(4) For any individual filter that hasa measured turbidity level of greaterthan 2.0 NTU in two consecutivemeasurements taken 15 minutes apart atany time in each of two consecutivemonths, the system must report thefilter number, the turbiditymeasurement, and the date(s) on whichthe exceedance occurred. In addition,the system must arrange for the conductof a comprehensive performanceevaluation by the State or a third partyapproved by the State no later than 30days following the exceedance and havethe evaluation completed and submittedto the State no later than 90 daysfollowing the exceedance.

PART 142—NATIONAL PRIMARYDRINKING WATER REGULATIONSIMPLEMENTATION

12. 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.

13. Section 142.14 is amended byrevising paragraphs (a)(3), (a)(4)(i), and(a)(4)(ii) introductory text, and addingparagraph (a)(7) to read 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 141.175of 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 Stateto 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 and


the reporting requirements of §§ 141.75and 141.175 of this chapter must be keptfor not less than one year.

(ii) Records of decisions made on asystem-by-system and case-by-case basisunder provisions of part 141, subpart Hor subpart P of this chapter, must bemade in writing and kept at the State.* * * * *

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

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

(ii) Records of decisions that a systemusing alternative filtration technologies,as allowed under § 141.173(b) of thischapter, can consistently achieve a 99.9percent removal and/or inactivation ofGiardia lamblia cysts, 99.99 percentremoval and/or inactivation of viruses,and 99 percent removal ofCryptosporidium oocysts. The decisionsmust include State-set enforceableturbidity limits for each system. A copyof the decision must be kept until thedecision is reversed or revised. TheState must provide a copy of thedecision to the system.

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

14. Section 142.15 is amended byadding paragraph (c)(5) to read asfollows:

§ 142.15 Reports by States.

* * * * *(c) * * *(5) Sanitary surveys. A list of subpart

H systems that have had a sanitarysurvey completed during the previousyear and an annual evaluation of theState’s program for conducting sanitarysurveys under § 141.16(b)(3) of thischapter.* * * * *

15. Section 142.16 is amended byredesignating paragraph (b)(1) as(b)(1)(i), and adding paragraphs(b)(1)(ii), (b)(3), and (g) to read asfollows:

§ 142.16 Special primacy requirements.

* * * * *(b) * * *(1) Enforceable requirements. (i)

* * *(ii) States must have the appropriate

rules or other authority to assure thatPWSs respond in writing to significantdeficiencies outlined in sanitary surveyreports required under paragraph (b)(3)

of this section no later than 45 days afterreceipt of the report, indicating how andon what schedule the system willaddress significant deficiencies noted inthe survey.

(iii) States must have the appropriaterules or other authority to assure thatPWSs take necessary steps to addresssignificant deficiencies identified insanitary survey reports required underparagraph (b)(3) of this section, if suchdeficiencies are within the control of thePWS and its governing body.* * * * *

(3) Sanitary survey. In addition to thegeneral requirements for sanitarysurveys contained in § 142.10(b)(2), anapplication must describe how the Statewill implement a sanitary surveyprogram that meets the requirements inparagraphs (b)(3)(i) through (v) of thissection. For the purposes of thisparagraph, ‘‘sanitary survey’’ means anonsite review of the water source(identifying sources of contaminationusing results of source waterassessments where available), facilities,equipment, operation, maintenance, andmonitoring compliance of a publicwater system to evaluate the adequacyof the system, its sources and operationsand the distribution of safe drinkingwater.

(i) The State must conduct sanitarysurveys for all surface water systems(including groundwater under theinfluence) that address the eightsanitary survey components listed inparagraphs (b)(3)(i)(A) through (H) ofthis section no less frequently thanevery three years for communitysystems and no less frequently thanevery five years for noncommunitysystems. The State may allow sanitarysurveys conducted after December 1995to serve as the first set of requiredsanitary surveys if the surveys addressthe eight sanitary survey componentslisted in paragraphs (b)(3)(i)(A) through(H) of this section.

(A) Source.(B) Treatment.(C) Distribution system.(D) Finished water storage.(E) Pumps, pump facilities, and

controls.(F) Monitoring and reporting and data

verification.(G) System management and

operation.(H) Operator compliance with State

requirements.(ii) For community systems

determined by the State to haveoutstanding performance based on priorsanitary surveys, subsequent sanitarysurveys may be conducted no less thanevery five years. In its primacy

application, the State must describehow it will decide whether a system hasoutstanding performance and is thuseligible for sanitary surveys at a reducedfrequency.

(iii) Components of a sanitary surveymay be completed as part of a staged orphased state review process within theestablished frequency.

(iv) When conducting sanitarysurveys for systems required to complywith the disinfection profilingrequirements in § 141.172 of thischapter, the State must also review thedisinfection profile as part of thesanitary survey.

(v) In its primacy application, theState must describe how it will decidewhether a deficiency identified during asanitary survey is significant for thepurposes of paragraph (b)(1)(ii) of thissection.* * * * *

(g) Requirements for States to adopt40 CFR part 141, subpart P EnhancedFiltration and Disinfection. In additionto the general primacy requirementsenumerated elsewhere in this part,including the requirement that Stateprovisions are no less stringent than thefederal requirements, an application forapproval of a State program revisionthat adopts 40 CFR part 141, subpart PEnhanced Filtration and Disinfection,must contain the information specifiedin this paragraph:

(1) Enforceable requirements. Statesmust have the appropriate rules or otherauthority to require PWSs to conduct aComposite Correction Program (CCP)and to assure that PWSs implement anyfollowup recommendations that resultas part of the CCP. The CCP consists oftwo elements—a ComprehensivePerformance Evaluation (CPE) andComprehensive Technical Assistance(CTA). A CPE is a thorough review andanalysis of a plant’s performance-basedcapabilities and associatedadministrative, 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. ACTA is the performance improvementphase that is implemented if the CPEresults indicate improved performancepotential. During the CTA phase, thesystem must identify and systematicallyaddress plant-specific factors. The CTAis a combination of utilizing CPE resultsas a basis for followup, implementingprocess control priority-settingtechniques and maintaining long-terminvolvement to systematically train staffand administrators.


(2) State practices or procedures. (i)Section 141.172(a)(3) of this chapter—How the State will approve a morerepresentative annual data set than thedata set determined under § 141.172(a)(1) or (2) of this chapter for thepurpose of determining applicability ofthe requirements of § 141.172 of thischapter.

(ii) Section 141.172(b)(5) of thischapter—How the State will approve amethod to calculate the logs ofinactivation for viruses for a system thatuses either chloramines or ozone forprimary disinfection.

(iii) Section 141.172(c) of thischapter—How the State will consult

with PWSs to evaluate modifications todisinfection practice.

(iv) Section 141.173(b) of thischapter—For filtration technologiesother than conventional filtrationtreatment, direct filtration, slow sandfiltration, or diatomaceous earthfiltration, how the State will determinethat a public water system may use afiltration technology if the PWSdemonstrates to the State, using pilotplant studies or other means, that thealternative filtration technology, incombination with disinfection treatmentthat meets the requirements of§ 141.172(b) of this chapter, consistentlyachieves 99.9 percent removal and/orinactivation of Giardia lamblia cysts

and 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. 98–32888 Filed 12–15–98; 8:45 am]

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