Document 3NkGmBeRx46q6jmOK1qKb5bN0

A/C Pi;- F'-oo'jie.'s Associolion Board of Directors International Affairs Committee F. Welch, Vice President \' U.S. Environmental Protection Agency (EPA) - National Revised Primary Drinking Water Regulations --" " REF:' (1) JFW correspondence, U.S. Environmental Protection Agency (EPA) Advance Notice of Proposed Rulemaking on Asbestos in Drinking Water, February 25, 1983 ACTION REQUIRED? Review for information Background The Safe Drinking Water Act (SDWA) directs EPA to review the National Interim Primary Drinking Water Regulations and issue National Revised Primary Drinking Water Regulations for contaminants in drinking water. This is the third phase in the evolution of EPA drinking water regulations. During this process (1977, 1980, 1982) the National Academy of Sciences (NAS) was engaged by EPA to assess health effects of various contaminants in drinking water and to propose "recommended maximum contaminant levels (RMCLs)" where "no known or anticipated effects on health of persons" would result. While NAS conducted the toxicological assessments, it declined to develop proposed RMCLs, stating this was a regulatory, rather than a scientific, function. Thus, EPA will use NAS studies and other scientific information to develop and publish RMCLs and "maximum contaminant levels" (MCLs) for substances meriting regulation. Current Status On October 5, 1983, EPA published an advance notice of proposed rulemaking (ANPRM) of its intentions to propose National Revised Primary Drinking Water Regulations (enclosed). The questions raised in the ANPRM are: 1. Which contaminants should be regulated? 2. What levels for RMCLs and MCLs would be appropriate? 3. IVhat monitoring and reporting requirements would be appropriate? In the context of the above issues, the ANPRM requests comments on asbestos in drinking water. The agency's remarks on asbestos are presented on pages 45515 and 45516 of the enclosure. Attention is also directed to page 45517, specifically the section entitled "Corrosion." AACPP Action Plan AACPP Strategic Operational Plan SOP-01-03 refers. Staff will meet with Kirkland & Ellis on October 14, 1983 to identify information needs and develop a work plan for preparing industry comments to the ANPRM. If you have any questions, please do not hesitate to call. CAPCO JEN OOI0655 JFW/ajb Enclosure cc: A. Kahn, Esq. Special Counsel (all states) AIA/NA AIA copies to: Board of Directors L. Ambler L. Cejudo J. M. Couture L. Taylor A. Verploegh 0172101401 Chrono r e. International Affairs Committee R. Dorner E. van der Rest A. Junes L. Giannitrapani G. Zaviezo J. Schmuas C. Barton F. Mansour M. Delcourt J. Cuvelier R. G. Cairns J. G. Cartuyvels H. Hudson R. Hobbs P. Hart A. Saoulis R. Jalan V. Pattabhi S. Al-Tarkait C. Snidvongs B. Giboin M. A. Elola L. Dolbeau CAP CO JEN OOI0656 ... i.- . r.P&r* * . ^r " l \ ** j._ -j .s, m v ..VffU::; *;:. 3 . : . . . :. v--;-'.'vl; ' .V1"'-'--'. `A: - i'i V" \ : ..-^Wednesday . '.October 5, 1933 / CAP CO JEN 0010657 45302 Federal Register / Vol. 48, No. 194 / Wednesday, October 5,1983 / Proposed Rules ENVIRONMENTAL PROTECTION be available for review during normal ' judgment, "no known or anticipated agency * business hours at the EPA, Room 55EB, ; adverse effects on the health of persons V 401M Street, SW., Washington, D.C. occur and which allows an adequate National Revised Primary Drinking 20460. It is requested that anyone T. margin of safety". Section 1412(b)(1)(B). Water Regulations planning to attend the public meeting ' - Congressional guidance on RMCLs for . (especially those who plan to make , carcinogens was contained in House 40 CFR Part 141 `V : / : ` statements) register in advance by * ..Report 93-1185: [WH-FRL 2418-1] . agency: Environmental Protection calling or writing Ms. Arnetta Davis at. 202/382-7575, EPA, WH-550,401M St., / ' ' '"I * *. * The Administrator must consider the possible impact of synergistic effects, long- ' SW., Washington, D.C. 20460. Persons term and multi-stage exposures, and the Agency (EPA). ?.... planning to make statements at the existence of more susceptible groups in the ' action: Advance notice of proposed rulemaking (ANPRM). ' ' '. . meeting are encouraged to submit ! /' "j ' population. Finally, the recommended - r . / . /written copies of their remarks at the 1 ; maximum level must be set to prevent the - / 'time of the meeting.- - occurrence of any known or anticipated . summary: EPA is today publishing this The public technical workshops will .y,` adverse effect, It must include an adequate - advance notice of its intention to . propose National Revised Primary -'"v Drinking Water Regulations (NPDWR) 'provide a forum for a full discussion of .'issues and a complete exchange of "/'/: - information and data. Registration for' margin of safety, unless there is no safe " ' threshold for a contaminant. In such a case, the recommended maximum contaminant " level should be set at zero level. A - !. ' for organic, inorganic, microbial and . `V ! the workshops and additional- radionuclide contaminants in drinking -I information can be obtained by -r .The primary drinking water '' water.-The Safe Drinking Water Act [42 * contacting AWWA Research ' regulations must also, set MCLs; MCLs"? USC 300f et seg.) (SDWA), following the - Foundation, 6666 West Quincy Ave.,- ` are the enforceable standards. MCLs * issuance of National Interim Primary Denver, Colorado 80235, which Is the\-',,.. must be set as cose to RMCLs as is Drinking Water Regulations [i.ei, Interim grantee conducting the workshops for feasible. Feasible means' Vwith the use. Regulations) directs EPA to issue- - ,. /EPA..;. v;V/\ :;-/' " ,.r: -A '. of the best technology, treatment . ... revised regulations! The foundation of FOR FURTHER INFORMATION CONTACT: ';!'.;' techniques and other means, which the the NPDVVR will be a comprehensive reassessment of the Interim Regulations' directed toward identifying chemicals in Joseph A! Cotruvo, Ph.D., Director, -Administratorfinds are generally . - Criteria and Standards Division, Office . available (taking costs into - <- . of Drinking Water (WH-550),: . ' ',/ consideration)". Section 1412(b)(3). drinking water for which national Environmental Protection Agency, 401 M In addition, the SDWA specifies that drinking water regulations would be''- ' Street, SW.,' Washington, D.C. 20460. primary drinking water regulations warranted. Detailed assessments will be telephone (202) 382-7575. " /'y \ ' contain criteria and procedures to made of the experiences since SUPPLEMENTARY INFORMATION: application of the Interim Regulations, occurrence frequency and human exposure potential, human health I. Statutory Requirements , II. Regulatory Framework III. NPDWR: Approaches Under concerns and basic toxicology, water. . -Consideration -. treatment technologies and costs, . J - IV.NPDWR: Regulatory Assessments assure a supply of water that complies with the MCLs. Section 1401(1)(D) 42 U.S.C. 3D0f(l)(D). Section 1445(a) authorizes EPA to require by regulation any public water supplier to keep . records, make reports, conduct analytical chemistry and monitoring V. NPDWR: Specific Considerations ' ' monitoring and provide such other ' methods and implementation options ; VI.References . that would optimize public health . ' ' .. VII. Request for Comments .... information as may be required to assist ...... . in determining compliance with the protection without unnecessary ..'....... I. Statutory Requirements '. SDWA, in evaluating health risks of economic burdens on the States and communities. ' `` EPA is issuing this ANPRM as an . :. invitation for the public to comment on all of the technical and regulatory issues that are being examined and requests . any information that will assist in the development of the NPDVVR. The Safe Drinking Water Act [42 ' . U.S.C.-300f, et seg.) ("SDWA" or "the' ' Act") requires the EPA to publish primary drinking water regulations .. which:-. .. 1. Apply to public water systems, . - 2. "Specify(s) contaminants which in ' ' the judgment of the Administrator, may ' unregulated contaminants, or in advising the public of such health risks. The SDWA also requires that the revised primary drinking water regulations be reviewed every three years and amended whenever changes in technology, treatment techniques or .other factors permit greater health DATESiWritten comments should be have any adverse effect on the health of protection. submitted by January 3^1983. A public' mecting.will be held on December 13; 1983, beginning at 9:00 a.in. in Room persons" [Section 1401(1), 42 U.S.C.- / The SDWA provides for the issuance "" 300g-l),and - !' . of variances to give legal protection to 3. Specify for each contaminant either systems that are unable to comply with 3906, EPA, 401M St. SW., Washington, (a) maximum contaminant levels (MCLs) the regulations, despite the application D.C. Public technical workshops will be or (b) treatment techniques. of treatment technologies, because of held in the following locations: A treatment technique requrement poor source quality. If a system will not Philadelphia, Pennsylvania--September - would only be set if "it is not be able to comply with an MCL after 21-23,1983 ' ' economically or technologically ' ... - installation and/or use of the "best . St. Louis. Missouri--October 4--6,1983 feasible" to ascertain the level of a . technology, treatment techniques, or Reno. Nevada--November 1-3,1983 contaminant in drinking water. .. other means which the Administrator Orlando, Florida--November 28-30,1983 In the revised primary drinking water finds to be generally available," taking addresses: Send written comments to regulations, "recommended maximum costs into consideration, the system may Comment Cleik, Criteria and Standards contaminant levels" (RMCLs) must also apply for a variance. Section Division, Office of Drinking Water be specified. RMCLs are non- 1415(a)(1)(A). 42 U.S.C. 300gM(a)[l)[A). (VVH-550). Environmental Protection enforceable health goals for public A variance, if granted, would insulate Agency, 401M Street, SVV,, Washington, water systems. RMCLs are to be set at a the system not in compliance from D.C. 204CO. A copy of all comments will level at which, in the Administrator's enforcement actions for exceeding the CAP CO JEN 0010658 Federal Register / Vol. 48, No. 194 / Wednesday, October 5, 1983 / Proposed Rules 45503. MCL. The system, however, would be microbiological, inorganic, organic, and In general'the approach for'all four* required in connection with a variance . radio-nuclide contaminants. At the phases will be similar.- to install and/or use "generally . direction of the Congress, EPA based th ;Initially an ANPRM will be ai uilable" treatment methods that Interim Regulations in large part on the published followed by a comment period would reduce the levels of a particular 1962 U.S. Public Health Service (PHS) and a public meeting. Public technical contaminant. Thus, the treatment Standards for drinking water which in workshops will also be held. The . method should be in-place to turn were derived from previous workshops provide an opportunity for' ' demonstrate that non-compliance is--.. standards dating as far back as 1915 for EPA to present the issues that must be - attributable to poor source water the microbiological standards and the- addressed in development of the quality, thereby entitling the system to a 1940's for the MCLs for some of the regulations and to receive information.- variance. However, this finding may be .... inorganic chemicals. .on scientific and technical matters as made prior to the methods actually .. As the second step. Section 1412(e) of .. well as receive comments on regulatory - '. being operational.The important fact is .. the SDWA directed EPA to'arrange for" - approaches. .... that the "available and effective"- : the National Academy of Sciences .; ". '' RMCLs will then be proposed '' . V .' ' methods be installed in order to reduce ... (NAS) to conduct a study to assess the followed by a public comment period - * \ contaminant levels! In addition,' health effects of contaminants in and a public hearing(s). ' pursuant to Section 1414(c)(2), 42 U.S.C. drinking water and to provide proposed 'RMCLs will then be promulgated 300g-3(c)(2) and 300g-4(a)(l)(A), any-V- RMCLs at levels at which there were and proposals published for MCLs, ' -.. system that receives a variance will be'. "no known or anticipated effects on the monitoring and reporting, and other put on a compliance schedule and .must health of persons * * *" The NAS requirements followed by a public . give notice of the variance to its V-. submitted its initial report, Drinking comment period and a public hearing(s). consumers. . Water and Health, to EPA in 1977 which Technologies will be identified that In addition to the primary regulation's,' was published in the Federal Register were used as the basis of determining the SDWA requires EPA to set for public comment; additional reports the MCLs; in addition, generally - Secondary Drinking Water Regulations' were submitted in 1980 and-1982. Whi!e:? available treatment technologies (GAT) which are to protect the public welfare. Congress envisioned that NAS would J:\ will be identified for use in the issuance The secondary regulations may apply to provide proposed RMCLs in the report,, j of variances. . ;-. _ ' J; any contaminant in drinking water tha ' the NAS stated essentially that it would? ,, The MCLs, monitoring and may adversely affect the odor or .. do toxicological assessments of- reporting, and other requirements ' appearance of the'water. Section 1401(2) contaminants in'drinking water but including GAT will then be promulgated.'. 42 U.S.C. 300g-l(c). Secondary \ developing proposed RMCLs was not an? An ANPRM for Phase I (volatile maximum contaminant levels (SMCLs) ' NAS responsibility but. an EPA" j synthetic organic chemicals) was issued and monitoring requirements have been regulatory function. In the words of the established (40 CFR Part 143,44 FR ' Academy, "determining safe levels to' 42195, July 19,1979).; In addition to the regulatory " mandates, the SDWA provides authorities for ensuring the safety of the nation's drinking water in a nonregulatory context. Section 1442(a)(2)(B) authorizes EPA to provide technical assistance to States and publicly owned ' water systems in response to and alleviation of any emergency situation which the Administrator determines to be a substantial danger to public health.. In the absence of appropriate State or locat action. Section 1431 authorizes ' EPA to take such-actions as the -. Administrator deems necessarv.to .protect the health of persons' drinking water containing contaminants requires consideration of other factors in addition to the harmful properties of the contaminants" (John S. Coleman. Executive Officer. NAS, Feb. 20,1975). The 1977 and subsequent NAS reports have provided EPA with toxicological assessments of contaminants in drinking water. Using this information and data"-., from other scientific sources, EPA will develop and publish RMCLs for some oft these substances. As the third step. Section 1412(b)(1)(B) and 1412(b)(2) provided that EPA must"s on March 4.1932 (47 FR 9350), and a ' public meeting was held in Washington, D.C., on April 28,1982. In addition, four public technical workshops were conducted across the country on volatile synthetic organic chemicals (VOCs) in drinking water. Today's ANPRM addresses Phases II and III and initiates the regulatory assessment of the Interim Regulations. The proposed revised regulations for radionuclides (Phase 111) will follow the Phase II proposal by approximately one * year. In addition, within Phase II, regulations for fluoride will be proposed separately in response to a petition filed by the State of South Carolina (see 46 protect public health from a -v:. propose and'promulg3te RMCLs"and ' FR 58345, December 1,1981). contaminant that may present an ' National Revised Primary Drinking ' ". ; While this ANPRM initiates the imminent and substantial endangerment to the health of persons. ,\VaterRegulations (NPDWR) that would' .include MCLs'and monitoring'and ' . ;' reporting requirements for thofee 'V formal rulemaking process for ' development of Phase II and III of the NPDWR, data collection and V ; Ht Regulatory Framework contaminants that may have an adverse developmental activites have been on The issuance of Revised Primary effect on human health. Drinking Water Regulations is the third Regulatory Development Approach step in the evolution of the primary . .. ' drinking water regulations mandated by Development of the NPDWR will be " the SDWA. accomplished in four phases: In the first step, the National Interim Phase I Volatile Synthetic Organic Primary Drinking Water Regulations Chemicals. going for the past several years. As part of these efforts, two public workshops have been conducted; a public workshop on the microbiological standards, was held on December 4-6. 1981, and a workshop on the radionuclide standards was held on were promulgated on December 24,1975. Phase II Synthetic Organic May-24-26,19S3. In addition, four public with an effective date of June 24.1977. Chemicals, Inorganic Chemicals and workshops will be conducted at several Amendments were issued in 1976.1979 Microbiological Contanimants . locations across the country during the and 1980. Maximum contaminant levels Phase 111 Radionuclides comment period for this ANPRM. ' (MCLs) and monitoring and reporting Phase IV Disinfectant By-Products Phase IV of the NPDWR will address requirements were set for numerous including Trihalomelhnnes trihalomethanes (THMs) and other CAPCO JEN 0010659 455M , # Federal Register / Vol.'. 48, No. 194 /- Wednesday, October 5, 1983 / Proposed Rules disinfection-related contaminant issues, ("This analysis would also be available 163,000 non-community systems. Most of since regulations for these substances for public comment. these systems are small and use ground have been in effect only since 1979 and The development process described water as their source; 90 percent of the this has not yet provided sufficient time above is intended to provide the............ systems serve 10 percent of the ' for a re-evaluation and revision to be greatest opportunity for all inte.ested population. Approximately two-thirds feasible. It is expected that by 1985 parties including States, communities, (i.e., over 38,000 systems) of all additional data on implementation with ' health and science experts, public ' community systems serve fewer than the THM regulations and other research . interest groups, water engineering and . S00 people. . .'. -- ` - ' . experience will be available including -treatment officials and citizens to . Status ofDrinking Water Quality. - new data on the nature and toxicology . participate and advise EPA on the. ' Despite improvements in disinfection of alternate disinfectants and their by- \ ' proper direction to be taken. .' : ?' h: . and other types of water treatment, products; at that time-EPA will review in:"NPDWR:'Apptdadi'es^i3nder. .J. ^outbreaks of waterborne disease still ' . tNaAcpefbswrEnnatcdmeprcssErthAtowcowfeacctchuuiefehpreaenefurPPdroopsoafhPlooosxaDfvodeiobasrealecprdeedsvnnsAkepDoetirnnivcrAntpavetcctutetrpedecigeegtakrcemoewe'ciitsssoWatorsisto'needrrtsaweresnsainiisahcuusrorirsnpsnfanmltiicopnsem,dnoceSiomtcnRtgtehmiasrOcorslgltewsuaaggde..eoaigyrgiiegtcmgeurse.ieTnatihflysspeprnseSfyrwlenduieoyftpcesefeseacttahseithptntacPiswh;ealtcsavuafhiipocxadnhcaxnlaeuoaeilioett(HaoartremiscnlleeeiacprieettteHtineidroasinsatsrlioeeisefeHltdededrAhooomrselo.tgastetocnAcrwnllsvriaine.iennpcaHeAentsrrtAsafdoibwdaiafiysalaenHaoivdcoshsssnuacsvkgcisdngADsind)rostaetamtilieniicoodileesesteiomstardcadfgvcgdwstwllrcbsutrsaamooelsosa-ycnehponiitociuewoperifunaotlmisuawonhdprealiaissoradmirovindtnenlsoontkfodearosemsirfhilta.ci-nfiefimsvecetgscoernionnedfaodtitrsvrabntnta.r,ehhtbtiyAieeosngnaienaHimeddfrhweeFogvtrddnoeycteudnrisdatctdesledheeBhc'ecfceeeoeiseon-uicrtWf.eeodncvagvteturmiaoetoediradIirvnhepnhcomaoedniivenoudVmomrnaosrevecldotaaiaftte,.inletnltvawte.bcioirnnosnaahoyilauhddttstoTrdctindoi-mmheeeepprstrntsieenenfrno.hteioiietspcredeoiroeafeehdah.bdt`irnnno.xeibifdn'erb.cirdncnsess(erfcypnkhiiyairndiAHoiayoserecnff.poiihae'sniosnnvbgs.picAeksedeaa'etkgyettouiawvsseallon.iritnsnr/nflihlrg-ectiiit;.g.c-hnlh'se.l,`.";\,'['..";-;-'"'.--';v"irCcier.oMrcn-8owaatUntiRN"neiegfedeRueamrm"orxo`oefcnov-vvexxceeqCagnqDrsenP*;penRtnIccldinpppaoaplahlapnundut_ugdniueLgDteoeuseeeeslalliiettieeeluiaWeekevrdliuslrrsFWmvw-amrsarWirrdaaFmicArrerCldneireme,lmisieipatoeSnadeeaewntibbiemietaheminppshontlRnoiothntrnnlgtrdonehgDeaiininllroaincapoeomgadlnlyyeecowecocapieaninittaetsWtuwcrtdntatsi;ttesenneenbimtfnntyepeytrhetasroolIeisarmaleeta,sdtoi.teengteblAn-hsiseenmnsnohsiesoactsto;ceqtanatesviatiod-xne,fue.,nohetceohniafubxwipnfr!lie-ao-stn7ntrhnnrvlt.snnevdcrntanaiemtrmca;dlehrlociiihebaseedo"eoottdmmnneneass,edhpgoohoueeot.ehloernlf'ms?eufasupob!eereaeanibprflixnoee*tnrtmindciIRiflipaaghasvrtfartnplferanynf~innrihchfaidaftiosiretbmeeeealoepkonbetcosgtsoootte*mi:etiebg,lghadhrdnirlitcerisiiqr_eNirpd'nneecovdistmalnariurIieej,gaiesun"inuriaesnnneegmnaPainomnqalni'aulmneagaiaR'gs~taiq'fatcpnddpuDcntnaamwfnpoeeesn.tttsoienup;stMeeiemeRreescddotndrsoW~cf.raeect.ci.rariswsaer?lsosnetntCtemoucertaiftoatqdthaheltssnpRhnrehsi7gapinditiLstulteotosoet'e,ntiloos.ieryhtu-nirotehesohsidonhwtmfsifdrril-ahnom'c:sinseaotercns'a.nsIi.tifeio.t"uoantm.nnfle,oein'i'iVblmTolots.lgtdk?ndt`rei.e.enhthno'.ei.t-stninreeshnno*itog,.mge;ssf.-f>'V..7.v:,;7'':."-'',.-.-.o3diocIccadonwicdricmfrndatdCi9nifrnhotlmnoce1onoheimocouenioiueoraesiilva6isfaeoau5efssoscsemacdmtrntMvsdttcnneofMopibdh0sbecnedwhtoupniloneirjetoDat-cboscleomrrmeaeaaoetrateardocvrsfoslagaoiersabrtreo,iasdtreseqssmp.qsnuoleemneahuienlnutvaiyemapietoesfoscutneeounmytadasdaeonieynikcikisaazslittnaatcnarainritkt.oonbodwhiias,oibnso,bemmttrtorriestttatsai,eMagnheoeveupyiehtabrlauenedoenla.teitcitayrued"yveoss-acrhereinntasirwtea.nafooAboeodteaennhCnlfutc.iatngth(crovocSdmolnujorbsnhitanriteeueaFtolntsduttoeoiatuefar.lurpleyhlnfdtduups2deroirepeoaaronoofettTtiqnrtomceeg0rushlbaeonmebcwaalrkftldttc1frenruhfaymn,ecreeafrilraert0sroMscctgr5oiiaonesieiostaihehscefoeplnuri0,fecouttis0frleflnylnatseient1tuiayeCseamupipoos0octtedrt0erscs(ekbpi9dspwarektwourroCriL-ans,ogotdwruceboscn7teho3igesslrninmelhsocnauctarraDninssrl1tota0nwmoibastooedee)icdasedodtotulytcio-e0Cfstautbhtndaeupeu6daafsssbo.sherenf7wrrws0ilmree)irsbns0rowiietgknlAtoe8tocretln,,bieeurwtaeeoyafar,msdssrla,oetubuowiaaccfysmsue0rprtsrcertntfyeotnngiaehetrcbkemuhot0wwepanthtthsbrrreetsrricihhisrbcs0pcoerhrieecfrroetegttoe,ria,iadretumeoeuhconoesrreopcuabwnmnactnrtsseenmphrvoseureeaotoasiCoenaer.gaoentnheyeistodtrekwesgecsrsrdnkidIrerbsrseytdottne.sonatdfeeondeeiat.ent.hlesfr,Inseenolayesifbnitstri`iat;atemneren!teiniptlho`rovn5nheimr-gsde'.""es0fngdV.e.-,'\...- Pursuant to Executive.Order 12291 (48''. Interim Regulations Implementation removal of inorganic chemicals c.an be FR13193. February 19,1981). EPA will ./ Experience ' difficult and relatively expensive cn a prepare a regulatory impact analysis- (RIA) prior to proposal if the Agency 2 determines that the NPDWR are The Interim Regulations include MCLs . per capital ba3is for small public water and monitoring and reporting systems. Problems continue primarily requirements for ten organic compounds with compliance with the MCLs for considered ``major rules''. (i.e., six pesticides and total arsenic, barium, lead (from pipe or in addition, pursuant to the trihalomeihanes). ten inorganic solder corrosion), fluoride and to an Regulatory Flexibility Act, an analysis compounds, microbial contaminants increasing degree, nitrate. of the impacts on small entities will be (coliforms and turbidity), nnd . In addition to the traditional' . conducted prior to proposal ofNPDWR radionuclides. Monitoring and reporting contaminants of mineral origin, the if the Agency determines such requirements are also included for presence of synthetic organic chemicals regulations are iikely to have a sodium and corrosivity. of industrial orgin (including pesticides) significant economic impact on a The regulations apply to some 60.000 . hns been detected with increasing substantial number of small entities. community water supply systems end frequency. ----tnltv in ground water Fedpral Register / Vol. 48, No. 194 / Wednesday, October 5, 1983 / Proposed Rules 4550o sources. Some surface waters are being Compliance with the Interim systems) within their boundaries. States contaminated with industrial and ' Regulations has been a problem mostly have reported that certain of these municipal wastes although in many for small systems. For example: inorganic compounds have not been cases, application of pollution controls The microbiological requirements detected at singificant levels in the has apparently improved surface water were not met by'many of the smaller drinking water in many systems and the quality in recent years. While the six ; systems (serving less than 3,300 people) probability of future contamination is pesticides in the Interim Regulations in 1982; the data show that 10 percent of very slight. Monitoring has shown that have seldom been found in drinking the systems violated the MCL and over 'little change in concentrations occurs water supplies, contamination of surface 25 percent violated the monitoring over time for certain contaminants, water by other pesticides'during runoff , requirements.'' ' primarily ground water contaminants. In can be a significant problem in certain ; > 'Of the large systems (serving over addition, some contaminants such as the areas; this has been shown by recent 'V.. ICO,000 people), 4 percent exceeded an six pesticides in the Interim Regulations, studies in Ohio in which finished ` MCL, and 3.7 percent failed to monitor..' have been found only rarely since " r drinking water levels of locally used" adequately. . / .'y. compliance monitoring requirements agricultural pesticides paralleled-; f';'J ''Although most small water systems'. went into effect. * v.v seasonal use.- N ... * deliver good quality water, when a These are areas which appear to }' ; Radionuclide contamination in ; ' problem does occur, a small community warrant significant modification in' ; drinking water can be due to natural or' - is generally least able to.cope with it. I' development of the NPDWR in order man-made radioactivity. Monitoring for . The cost of treatment is sometimes that public water system and State man-made radioactivity currently ; beyond the economic capability of the' resources will be used more efficiently applies only to surface water supplies .-. small system, and the skilled manpower .to be more reflective of local or regional serving populations larger than 100,000. necessary to operate treatment facilities There have been no violations reported is even more difficult .to obtain.. of the MCL for man-made radioactivity, ' ' For those systems not in compliance . conditions. * '. .. * 'Approaches Under Consideration .. . * The regulations for radium apply to all . with various MCLs, in particular some of As outlined above, several problems public water systems and monitoring . the MCLs for inorganic chemicals, the with the Interim Regulations and their -has shown that approximately 500 - problems are generally because of the implementation need to be addressed in public water supplies exceed the MCL. . costs and feasibility of installing and the developmental efforts leading to the for radium (a natural contaminant). operating treatment facilities. However, NPDWR. The regulatory approaches Uranium and radon, though not included this compliance problem goes beyond currently under consideration to address in current regulations, occur with .. the question of costs and includes the these problems are discussed below. . comparable frequency. .. issue of potential health effects While contamination of source waters has traditionally been the primary, concern, attention must also be given to the impact of treatment and distribution on the quality of water delivered to the consumer. For example, chlorine used in water treatment generates--' . especially for naturally occurring (particularly in ground water supplies) contaminants like radium, selenium. .. barium, and fluoride. Some of these systems, many of which are small, remain unconvinced that the net benefits of contaminant reduction are worth their costs. Compliance by (Small) Systems The NPDWR would identify technologies representative of generally, available treatments described in the SDWA. The approach would be similar -to. that promulgated for the trihalomethane regulations (40 CFR Part 142. 48 FR 8406, February 28,1983). trihalomethanes and other organic chemicals; other treatment chemicals may contribute traces of contaminants from impurities or residues. The ,, materials used to construct and preserve'/ the conduits and storage facilities for drinking water as well as plumbing in'--.if the home can also contribute >4' contaminants such as metals and - J - Monitoring Experience. The SDWA assigns to EPA the responsibility for . developing national primary drinking water regulations which contain the minimum national requirements for the assurance of safe drinking water. States which have primary enforcement responsibility must adopt regulations which are no less stringent than the These would assist States in issuing . . variances. , Variances may be granted when a system, "because of characteristics of the raw water sources which are reasonably available to the systems, cannot meet the requirements * * *: .. despite application of the best technology, treatment techniques, or organic-residues from surface coatings.'- - national regulations. State regulations other means, which the Administrator Eacterial growths in distribution ' may contain more detailed monitoring finds are generally available (taking systems are ajamiliar characteristic requirements or more specific criteria costs into consideration)." (Section especially of older systems or where- - end procedures than do the national 1415(a)(1)(A)). Variances do not have a - water is inadequately treated. ' regulations. . .' fixed date in the law for the system to Compliance Problems With the The Interim Regulations require come into compliance but the.system Interim:Regalelions. During fiscal year monitoring to assess compliance with must be put on a compliance schedule. . 3952, over 70,000 violations of the the MCLs at set frequencies for certain Generally available technology (GAT) Interim Regulations were recorded by ( contaminants; for example, monitoring would be defined for each regulated 20,000 of the community water systems. for inorganic compounds must be contaminant, taking costs into Most of these violations were for conducted at least once per year or once consideration and possibly categorizing monitoring and reporting (84%) but it is per three years for supplies using by system characteristics such as size or estimated that over 9,000 systems surface or ground water sources, water source. States would evaluate require improved facilities to meet respectively. While monitoring once a each case on 0 site-specific basis to drinking water standards. Compliance year or every three years does not seem determine if the identified GAT was records for non-community systems to be overly demanding, this can be a appropriate and effective for that were incomplete but do indicate that burden upon small system, and upon system. In addition to central treatment monitoring is generally not being those States that conduct monitoring for alternatives, use of bottled water and conducted on schedule. certain of the systems (e.g.. small point-of-use treatment devices are being CAP CO JEN 0010661 45506 Federal Register / Vol. 48. No. 194 / Wednesday. October 5, 1983 / Proposed Rules considered as means of reaching . record. Contaminants such as natural with peer review by leading - =- compliance with the NPDWR.. radionuclides, certain pesticides and toxicologists. '. . In addition to identification of GAT ' ' some inorganics such as barium may and the-associated costs of contaminant well be predictable; thus, repeated ; .. IV. NPDWR: Regulatory Assessments rcdncfton. EPA will provide for public monitoring according to the present comment comprehensive health criteria . formula may use resources for.non- This section provid :s background documents for each of the .contaminants productive monitoring, once compliance information on the issues and to be included in the NPDWR. These status has been determined and source . . alternatives that must be considered in documents will contain detailed. .. .. - conditions are stablized. determining the appropriate levels for ; assessments of all available information' Cases such as these appear to warrant .RMCLs and MCLs and the specific .' and will fulfill the mandate's of .. .* conferring the maximum discretion with moniforing/reporting requirements. , '. evaluating the risks of contaminants in' States'so that activities can be'tailo'red ..- Public 'comments and information are' ' / drinking water and the design of the ` to regional conditions. Thus, although an'- requested that will assist.EPA in making- regulatory framework for them. ' 'MCL identical to Category I would be these determinations/'-. :Thre^ieredApproach?, developed by EPA, and compliance with . the MCL would be required in all cases, tRMCLs'f .'..V.' A three tiered approach'has been-"/ ' developed for determining whether and In what manner to regulate specific.'/'''/; States could be provided flexibility in ;' RMCLs are to be set at levels at establishing monitoring requirements','.''/;,;. which: .....; ;within stated criteria./-..'. / '' contaminants. This approach was'" i'::- '/ ' In addition, some contaminants such /'' No knovvn'or anticipated adverse effects on discussed in the public meetings on the 3. ' as nitrate may be of concern to a ' '/. ' /.' . the health of persons occur and which allow : Safe Drinking Water Act in February-. '-v definable portion of the population, e.g., an adequate margin of safety.-' ' 1982 and by the National Drinking : youngchildrenbelowacertainage.lt .Water Advisory Council in March -1982 may be.possible to provide flexibility to For those toxic compounds for which and was widely supported. . States in applying a standard when the.. there may be no threshold (e.g., Drinking water contaminants would V high risk population is not exposed. ' ' carcinogens), the House Report 93-1135...' be divided into three categories for * ' regulatory purposes: `CategoryJIIjjoriiatniriantsj .-- _suggested that.the "no effect".level : - should be zero. -. :. ,, *. ,./ :. /; Category I.--Those which occur with / Over the past few years, particularly ' RMCLs: Scientific Approaches. When ' sufficient frequency and which are of in connnection'with contamination of appropriate data are available from sufficient concern-to warrant national ground waters by organic solvents-and ' human epidemiology or animal studies.' ' regulation (MCLs) and consistent . pesticides, there has been a ne.ed for..-. determination of the "no effect" level for ' monitoring and reporting. . rapid determination of "safe" or - RMCL purposes for toxic agents not Category II:--Those which are of `'acceptable" levels of these `- ; . considered to have carcinogenic sufficient concern to warrant national contaminants in drinking water for short potential is a relatively well-accepted ' regulation (MCLs) but which occur at ' periods of consumption. Advice is often procedure. In classical toxicology, "no. : frequency, justifying flexible needed in a very short time to determine effect" levels for chronic or lifetime '-mal minimum monitoring whether immediate control is necessary. periods of exposure are referred to jitirements to be applied by State 'In many cases the need has been met by . commonly as ADIs or Acceptable Daily authorities. - issuing Health Advisories which provide #. Intakes. These ADIs are defined as. Category ///.--Those which'would not-' information on the health effects of exposure levels which would be without warrant development-of a regulation but / unregulated contaminants so that users risk to humans when received daily over for which non-regulatory health...... of the water in question can be assisted a lifetime. For non-carcinogenic end guidance could be provided to States or in determining what action to take. - water systems. .............. - - Health Advisories are developed for Category I Contaminants .i , various lengths of exposure, from one day to longer term (up to one to two - Certain contaminants such as s - years), depending on the availability of coliforms. turbidity and some inorganic date. . . and organic chemicals are widely . . While some of the contaminants for detected in drinking water supplies and which Health Advisories have been ' pose serious health risks when MCLs .' prepared may occur with sufficient. * are exceeded. Without consistent or . frequency and at high enough - -. frequent oversight, these MCLs have a : concentrations to be considered for . .-- high potential for being exceeded. Such NPDWR, there undoubtedly will be a points of toxicity, it is assumed that an organism can tolerate and detoxify some amount of a toxic agent without ill effect up to a certain dose or threshold. A threshold is defined as that dose'of a given substance which is required to ' elicit a'measurable biologic response.' .: As the threshold is exceeded, the extent of the response will be a function of the dose applied and the length'of time exposed. - .- -. . contaminants warrant national large number of contaminants which do The intent of a toxicological analysis aegufafibgffi wilfe fixed', minimum not merit that level of regulation. In performed as part of the regulatory requirement's, including regular these latter cases, EPA would not development process is to identify the ` monitoring requirements. States would establish NPDWRs but provide non- highest no-observed-adverse-effect-level be required to adopt and apply those regulatory advisories when requested (NOAEL) based upon assessment of regulations as written; States could by a State or public water system. These human or animal data (usually from produce more stringent requirements as advisories would be produced through a animal experiments). To determine the neederL process that would integrate activities in ADI or RMCL "no effect" level, the the various EPA program offices NOAEL is divided by appropriate Category II Contaminants including the Office of Drinking Water "uncertainty" or "safety" factors. This The occurrence of many drinking and the Office of Pesticide Programs. process accommodates for the water contaminants is sometimes Development of the advisories would extrapolation of animal data to the predictable based upon geological - include intensive scientific and technical human, for the existence of weak or ' conditions, source type, and historical evaluation of available data coupled insufficient data and for differences in CAP CO JEN 0010662 Federal Register / Vol. 48, No. 194 / Wednesday, October 5, 1983 / Proposed Rules 45597 human sensitivity to toxic agents, among other factors. General guidelines were.. providedby the NAS Safe Drinking;::' Water Committee which state that an1";uncertainty factor of 10 is used if there' exist valid experimental results^via-/.; . ingestion in'humansrah uncertainty':?,:. .animal data; Additional factors also factor of 100 is used if there'exist valid may be used if the circumstance dictate experimental results on long-termit. * .feeding studies on experimental- The process by which an ADI ur ' ''animals; and an uncertainty factor of\ RMCL "no effect" level for humans is ;'1000 is.used if there'exist_inadequate^;'f established is illustrated in Figure 1. Dose '' ' I' . A: .'"NOAEL' (experimentally : - '= derived) : B:--''.NOAEL (theoretically /'./..-..possible) C: -.ADI or RMCL "np effect?'- ;.V.;level! .. ' ' .v*' .... ..-%!! . D: .'...Presumed threshold for ./.--any effect (not adverse) D^t ` Another possible presumed threshold for any effect .. , ; \ . v-..(not-adverse) -D2S Non-threshold end point of toxicity CAP CO JEN 0010663 45508 Federal Register / Vol. 48. .No. 194 /'Wednesday, October'5, 1983 / Prpposed Rules Figure 1 shows the lower end of,a as evidence which provides indirect finds are generally available (taking ' typical sigmoid-shaped dose-response support (e.g., mutagenicity and other costs into consideration)." curve as might be generated > -. short-term test results). This process is . Thus, MCLs are based upon a' ''' experimentally for a non-carcinogenic difficult since the reduction of cancer :. balancing of numerous factors including:./ en '-point of toxicity believed to have a is a multistage eve.... determined by a. Potential health risks: threshold. The solid line represents the.,, multiplicity of mechanisms, the nature of Performance of available treatment . curve as experimentally-determined. . which remain, for the most part, technologies: Point A represents the highest NOAEL hypothesized rather than identified. Feasibility and costs of treatment: determined during the experiment. Point To date, scientists have been unable and - - . ~ D represents the threshold dose at or to demonstrate experimentally a .' ... Analytical methods: levels of " ' above which any effect would be ' threshold of effect for "carcinogens,!' ' precision and accuracy attainable by " elicited. The distinction between D and according to the 1977 report of the NAS qualified laboratories " ' .* A is that there may be an effect of the. ' Safe Drinking Water Committee.-Thisjc. . As part of this analysis,'generally .' V applied dose at D but this effect is of r finding leads to the assumption.that'v-"?* available treatment (GAT) (as defined in such a nature or magnitude's to not be '' since.no safe exposure dose can be Section 1412(b)) is identified (see ' ; considered adverse-, the effect xvould be ^demonstrated forcarcinogens,'any< */ discussion in Section III) along with considered adverse somewhere on-the " .exposure represents some finite level of-/ levels of contaminant reduction that can curve between Point D and Point A and risk. Depending upon the potency of the./ .- be achieved,- and the associated costs is represented by Point B. Point B may - specific carcinogen and the level, such a? are determined. The costs of achieving a ' be the actual no adverse effect level, if ' ! risk.wouldbe vanishingly small at very ' specific level are examined on the basis . the experimental procedure which determined Point A were not sufficiently sensitive to measure the precise response relatable to an ultimate human low.'ddses.' . ~ Human epidemiology'dataare'!;'^ extremely limited in their ability to.i '.fdentify.carcinogenic risks. Thus, animal of costs to individual public water -.' systems as well as aggregated to determine national cost impacts. The " ; level of contaminant reduction risk. .-. .. r experiments are conducted from which considered to be reasonable'or feasible To derive the human RMCL "no . .'potential human risk is extrapolated. In is then translated into the MCL, with effect" level or ADI based upon the the first volume of Drinking Water and experimentally derived data displayed ' - Health, the NAS Safe Drinking Water due consideration given to other pertinent factors. in Figure 1. the appropriate margin of Committee provided principles to serve Public comments are requested on safety (i.e,, uncertainty factor) is applied as guidance to EPA when assessing the what factors should be considered in the to establish an acceptable level of irreversible effects. . analyses, including: exposure, depicted as Point C. The Principle 1: Effects in animals. What engineering and technical objective of applying the uncertainty properly qualified, are applicable to . feasibility criteria should be used to set factor Is to make Point C below the no man. GAT? -dverse effect level. Point B. Thus. Point . Principle 2: Methods do. not now exist . - What is a reasonable cost for the C would represent the ADI or RMCL "no to establish a threshold for long term consumer? ' ' ' ' effect" level with a margin of safety. It is effects of toxic agents. What other factors should be possible that the actual dose response Principle 3: The exposure of considered as pertinent in determination curve would result in Point Di. in which experimental animals to toxic agents in of. the levels for MCLs? case the ADI or RMCL "no effect" level (i.e., Point C) might not be below the high doses is a necessary and valid method of discovering possible Monitoring/Reporting presumed threshold for any effect. carcinogenic hazards in man. The objective of monitoring is to There is suggestive scientific evidence Principle 4: Material should be assure compliance with the MCLs and, available to postulate that thresholds do assessed in terms of human risk, rather of course, toTndicate the quality of the exist for noncarcinogenic end-points of .than "safe" or "unsafe". drinking water. Monitoring requirements toxicity. In the absence of irrefutable Many of the substances treated in this will vary depending upon which _ - evidence, however, it remains ANPRM are not considered to be contaminants and into which Category theoretically possible that one or more 'noncarcinogenic end-points may not carcinogens. The issue of RMCLs and (i.e., of the three tiered approach MCLs for carcinogens was discussed in discussed previously) the contaminants have a demonstrable threshold. The the ANPRM for VOCs {47 FR 9350) and have been placed. The primary " dose-response curve for this case is will be discussed at length in the . considerations include: depicted as the dashed line from Point A forthcoming proposed RMCLs for VOCs. Frequency of sampling: to the origin or Dj.D. represents the J. Public comments are requested on the Number of samples: threshold dose and the RMCL "no establishment of RMCLs including the Locations of samples: in the effect" level.fir t&is, case would thus be .. methodology for assessing non distribution system, at the plant, or each zero. carcinogenic toxic effects and the use of well; Determination of RMCL "no effect"- -s the ADI as the RMCL. In addition, public ' Availability of reliable analytical levels for substances which may possess ' comments are requested on the method methods: carcinogenic potential is a two-phase. to be used to determine the level that Precision/accuracy of analytical process. In the first phase, the' . should be set for RMCLs for methods: toxicological data base for non- carcinogens.- Availability of qualified carcmogenic end-points of toxicity is evaluated in the same manner as MCLs! t laboratories: Costs of monitoring: and. described above for "noncarciriogens". Section 1412(b)(3) requires that MCLs Distinctions between surface and - In the second phase, assessment is be set "as close to" the RMCLs "as is ground water sources. made of the evidence which measures feasible". Feasible means "with the use Public comment is requested on the directly the carcinogenic potential (e.g., of the best technology, treatment and above factors and how they would long-term bioassays in rodents) as well other means, which the Administrator apply to the contaminants under CAPCO JEN O01 0664- Federal Register / Vol. 48, No. 194 / Wednesday, October 5, 1983 / Proposed Rules 45509 consideration. In addition assistance is systems serving 25 to 1,000 persons. outbreaks of. giardiasis with about 20.000" requested on factors that should be used Turbidity monitoring is required daily reported cases. ' in determining reduced (or increased) for systems using surface water 1 At the present time, there is no simple monitoring requirements, such as quality supplies. and reliable method for assaying of the water supply based upon Although coliforms are not usually Giardia cysts in water samples. sampling or a sanitary survey, proximity pathogenic, their presence in water to hazardous waste sites, or proximity to implies that human microbial pathogens potential contamination sources such as may be present. The concept of coliform upstream industrial pollutant discharges. measurements as a practical indicator of or pesticide usage. tr- i? .' microbiological quality is universally .. Public comment is also requested on f.l accepted, but there have been numerous appropriate reporting requirements for f,'other parameters suggested as means for public water systems such that ;v judging the microbiological quality of ' efficient procedure is followed for j;^^; drinking water. While the coliform determining compliance while minimizing paperwork. Current ' 'measurement still appears to be the :. preferred parameter, as confirmed by requirements are (1) to report any recent symposia and workshops, there positive samples above MCLs (after --:Vi - appears to be a need to reconsider and appropriate check or follow-up update the regulatory framework. The sampling) within 48 hours and (2) to' current regulations for microbiological' report routine monitoring data either (a) contaminants are admittedly 10 days following the month in which ,. complicated; there are two analytical the result is received or (b) within the '; ' procedures, the sampling frequency is first 10 days following.the end of a . . variable, the volume of sample to be monitoring period..^.. examined is variable, and there are " Microscopic methods for detection and enumeration are tedious and require skill and patience on the part of the examiner. . Giardia cysts are relatively resisitant to chloride, but preliminary evidence indicates that cysts can be killed at ' ' warmer temperatures (e.g., 20* C) with ' ' 1.5 mg/l chlorine for 10 minutes.. Filtration, whether through .'' diatomaceous earth or granular medial has been show to be effective for. removing cysts of Giardia and another pathogenic protozoan, Entamoeba . ' .5 histolytica. '. .' Viruses have been implicated in . numeropus outbreaks of waterborne ' disease. Between 1978 and 1931,12 waterborne outbreaks involving about ' 5,000 cases were attributed to viruses. iVrNPD'VyRrSp'ecificConsiderations ; ' MCLs for single samples and for , monthly averages; in addition the . Undoubtedly, the reported number of . .outbreaks is substantially lower than Discusse'd beloware" specific . concept of "check" samples is frequently actual numbers. Moreover, in about half contaminants which are being r/f'?' ' misunderstood, in large parfbecause the the outbreaks of waterborne disease, the considered for inclusion in' the NPDWR'.. term "check samples" is not an accurate causative agent has not been found. For each contaminant EPA is assessing .' description" of the samples or their There is growing suspicion that most of the current K1CL and monitoring ' . purpose. EPA's goal for the NPDWR is these are due to viruses. These requirements and requesting assistance to streamline, to the extent feasible,.the organisms are generally more resistant n defermining answers to the following; complex aspects of existing to disinfection than coliforms, and thus ' For which contaminants are RMCLs .microbiological regulations and to may be present in drinking waters and MCLs appropriate under the SDWA assure that meeting the regulations will meeting current regulations. Because of requirements? In addition to those assure safe drinking water. In addition these factors, viruses are being discussed below, which additional to coliforms and turbidity, consideration considered for inclusion in the NPDWR.' substances should be considered? . What additional data are available to support the determination of appropriate RMCLs and MCLs? Given the toxicology and occurrence characteristics, what monitoring and reporting requirements would be appropriate in each case? . - . Microbiology and Turbidity ':' . " The microbiological aspect of drinking water quality has been the subject of standards since 1914. The Interim Regulations, as do most of the earlier standards, rely on the measurement of total coliforms and turbidity as . indfeafoss of fecal pollution and water tieatineiT? efficiency, respeetively. Specific MCL requirements of the Interim Regulations, simply stated, are .. the following: is being given to the following drinking water microbiology issues in the NPDWR in light of recommendations from the Drinking Water Microbiology Workshop. Giardia lamblia Viruses .. Standard plate count Legionella ' Filtration treatment for surface water Disinfection requirement ' As noted above, development of NPDWR will not only inyolve addressing current requirements in the Interim Regulations but will also evaluate new controls for such contaminants as Giardia lamblia and viruses. Giardia lamblia is a protozoan which is a human intestinal parasite and is the cause of giardiasis,' a disease Some of the information needed to develop RMCLs and MCLs for Giardia and-or viruses would include dose- response data, which are currently limited, and suitable recovery and assay methods. Alternatives under consideration include: 1. Because analytical methods do not appear to be "economically or technically feasible" (Section 1401(l)(c)(ii)) and because conventional drinking water treatment technologies are effective in removing Giardia and/or viruses, one option would be to ; - - establish a treatment technique requirement consisting of filtration and disinfection for surface water systems. 2. On the other hand, perhaps a hybrid approach could be considered where " RMCLs and MCLs and a treatment technique requirement would be set; Total eoUerm*____ 1 po* 100 ml monthly fcveteg*. 4 par 100 ml vlnjlo sarrpi*. which can be mild or extremely debilitating. Giardia infections can be States would than be able to allow installation and operation of appropriate Twt*3*1 Tu'bttiy Unit (TU) (op Ip 5 TU). acquired by ingesting viable cysts from technologies in lieu of expensive food or water. Several outbreaks of monitoring that would be associated Monitoring requirements for coliforms, giardiasis have been traced to municipal with MCL compliance requirements. depending upon the siie of system, range from 500 samples per month for systems serving more than 4.7 million persons to one sample per month for water" supplies, and humans and both wild and domestic animals have been implicated as hosts. Between 1972 and 1980 there were 33 reported waterborne Legionella is being considered for inclusion in the NPDWR. This bacteria is responsible for causing Legionnaires Disease and Pontiac Fever and many CAP CO JEN 0010665 Federal Register / Vol. 48, No. 194 / Wednesday, October 5, 1983 / Proposed Rules 45509 consideration. In addition assistance is ' systems serving 25 to 1,000 persons. outbreaks of giardiasis with about 20.000 requested on factors that should be used Turbidity monitoring is required daily reported cases. in determining reduced (or increased} . for systems using surface water ' At the present time, there is no simple monitoring requirements, such as quality supplies.... .> . and reliable method for assaying .;... of the water Bupply based upon Although coliforms are not usually sampling or a sanitary survey, proximity _ pathogenic, their presence in water Giardia cysts in water samples. Microscopic methods for detection, and to hazardous waste sites, or proximity to . implies that human microbial pathogens enumeration are tedious and require potential contamination sources such os may be present. The concept of coliform skill and patience on the part of the upstream industrial pollutant discharges' , measurements as a practical indicator of . examiner. ':`- `or pesticide usage. .,' - microbiological quality is universally Giardia cysts are relatively resistant - . Public comment is also requested on.',! ^accepted, but there have been numerous to chloride, but preliminary evidence ' appropriate reporting requirements for/;:-'.'' other parameters suggested as means for indicates that cysts can be killed at . public water systems such that judging the microbiological quality of ` warmer temperatures (e.g., 20* CJ with efficient procedure is followed for .)j!^!'!!'. drinking water. While the coliform 1.5 mg/l chlorine for 10 minutes. . determining compliance while '/measurement still appears to be the ' Filtration, whether through minimizing paperwork Current preferred parameter, as confirmed by diatomaceous earth or granular media, ' .requirements are (1) to report any I recent symposia and workshops, there positive samples above MCLs (after.;'" Vappears to be a need to reconsider and appropriate check or follow-up !:': /update the regulatory framework. The sampling} within 48 hours and (2) to'- j- current regulations for microbiological' has been show to be effective for ; removing cysts of Giardia and another pathogenic protozoan. Entamoeba \" "' histolytica. report routine monitoring data either (a) 10 days following the month in which .contaminants are admittedly complicated: there are two analytical;'' the result is received or (b} within the first 10 days following the end of a monitoring period..;'. .,' !;'/.. ' procedures, the sampling frequency is : variable, the volume of sample to be examined is variable, and there are " Viruses have been implica''\i . . numeropus outbreaks of.wa ; me"' disease. Between 1978 and 1. .2 waterborne outbreaks involving about ' 5,000 cases were attributed to viruses.- ^yrNPb\V^^p'e^c Considerations ; ;. - MCLs for single samples and for, . Undoubtedly, the reported number of " - monthly averages: in addition the.' . outbreaks is substantially lower than Discussed below are .`specific;rjXtiTTvi . concept of "check" samples is frequently actual numbers. Moreover, in about half contaminants which are.being ' ' misunderstood, in large part because the the outbreaks of waterborne disease, the considered for inclusion in .the NPDWR1. term "check samples" is not an accurate causative agent has not been found. For each contaminant EPA is assessing description of the samples or their There is growing suspicion that most of the current MCL and monitoring . I purpose.'EPA's goal for the NPDVVR is these are due to viruses. These requirements and requesting assistance." ' to streamline, to the extent feasible,.the organisms are generally more resistant m'detcrminihg'answers to the following: complex aspects of existing to disinfection than coliforms, and thus ' . For which contaminants are RMCLs .microbiological regulations and to may be present in drinking waters and MCLs appropriate under the SDWA assure that meeting the regulations will meeting current regulations. Because of requirements? In addition to those assure safe drinking water. In addition these factors, viruses are being discussed below, which additional to coliforms and turbidity, consideration considered for inclusion in the NPDWR.' substances should be considered? . What additional data are available to support the determination of appropriate RMCLs and MCLs? * Given the toxicology and . occurrence characteristics, what monitoring and reporting requirements ' is being given to the following drinking water microbiology issues in the NPDWR in light of recommendations from the Drinking Water Microbiology Workshop. ' Ciardia lemblia would be appropriate in each case?. Viruses Microbiology and Turbidity^ ., " Standard plate count ,.. Legionella The microbiological aspect of drinking ' Filtration treatment for surface water water quality has been the subject of standards since 1914. The Interim Regulations, as do most of the earlier standards, rely on the measurement of total coliforms and turbidity as Indicators of fecal pollution and water ` treatment efficiency,,respectively; Specific MCL requirements of the Interim Regulations, simply stated, are . the following: - Disinfection requirement " As noted above, development of NPDWR will not only inyolve addressing current requirements in the Interim Regulations but will also evaluate new controls for such contaminants as Giardia lemblia and viruses. Giardia lamblia is a protozoan which is a human intestinal parasite and is the cause of giardiasis, a disease Some of the information needed to develop RMCLs and MCLs for Giardia and-or viruses would include doseresponse data, which are currently limited, and suitable recovery and assay methods. Alternatives under consideration include: 1. Because analytical methods do not appear to be "economically or technically feasible" (Section 1401(l][c}(ii}) and because conventional drinking water treatment technologies are effective in removing Giardia and/or viruses, one option would be to establish a treatment technique requirement consisting of filtration and disinfection for surface water systems. 2. On the other hand, perhaps a hybrid approach could be considered where ` RMCLs and MCLs and a treatment technique requirement would be set; Total edifonn*______ 1 por 100 ml monthly which can be mild or extremely States would than be able to allow 4 pdf 100 ml w'xjte debilitating. Giardia infections can be installation and operation of appropriate TcetfCtf. , , ,,, t tWr (TU) to 5 TU). acquired by ingesting viable cysts from technologies in lieu of expensive food or water. Several outbreaks of monitoring that would be associated Monitoring requirements for coliforms, giardiasis have been traced to municipal with MCL compliance requirements. depending upon the siie of system, water supplies, end humans and both Legionella is being considered for range from 500 samples per month for wild and domestic animals have been inclusion in the NPDVVR. This bacteria systems serving more than 4.7 million implicated as hosts. Between 1972 and is responsible for causing Legionnaires persons to one sample per month for 1980 there were 38 reported waterborne Disease and Pontiac Fever and many CAP CO JEN 0010666 Federal Register / Vol. 48, No. 194 / Wednesday, October 5, 1933 / Proposed Rules 45511 of the currently existing population- indiscriminantly, but based on the corrosion.' The above inorganic frequency relationship; (2) five samples/ specific situatior. Some participants chemicals, end their associated __ month end use of the tote! length of recommended a 30-hour maximum limit monitoring requirements of one per year pipes in the distribution system es a on unrefrigerated samples and 54 hours for surface water supplies and once per be. s for frequency of sampling. The on refrigerated ones. - ' three years for ground water supplies, minimum number of samples for the largest category of systems should . ` Some participants suggested that ere being reviewed by EPA for possible coliforms be defined as any rod-shaped, inclusion, with or without modifications, remain DOO/month. . gram-negative, facultative anaerobe ' In the NPDWR. Additional inorganic' . SPC levels should be monitored at\ which ferments lactose in 48 hours at chemicals are also being considered as"-' the same frequency as coliforms, at least 35*C. This would include the genus 'listed below. Inclusion in'the list' doesv"7 initially until a data base is established. Aeromonas. .. -:,:1 ' not necessarily mean thatregulations----''.- , Monitoring for turbidity should be .. Source Water, Treatment and " will be developed; other inorganics may'-' increased to one each eight hours unless '. 'Distribution System Requirements. On-,, also be included iii the regulations^if^/ continuous monitoring Is provided. The .. the subject of treatment guidelines and ' determiiied'to be'appropriateV"7 "... average of the three analyses should be . requirements, the following coricltisions reported as the daily value or, with emerged. . ' Aluminum. Antimony f* *'' Sodium............ ;, Nickel ; continuous monitoring, the average of _ . The issue of establishing a water Molybdenum s ` Zinc - the graphical record should be used... V quality index; relating raw water quality Some monitoring for specific and treatment requirements, was . pathogens which are not directly related . discussed. It was felt that sufficient data to fecal indicator counts in finished - ; on a variety of parameters'do not exist water were also recommended. See the ' to allow establishment of such an index. '`Proceedings'' document for more detail. Instead, minimum treatment on these recommendation. ` ' requirements for water .supply sources .The existing sampling regulations were recommended." - . for non-community water systems ` Minimum treatment for ground (NCWS) ( 141.21 (c)) are adequate for water sources should be disinfection. small systems. It was recommended that All surface water sources should be NCWS serving more than 500 persons, pretreated by such processes as per day be required to sample at the coagulation, sedimentation and filtration same frequency as community water or their equivalent prior to disinfection, systems of similar size. . " : unless it can be shown on the basis of'a All systems using surface water, sanitary survey that such treatment is except small systems, should provide not necessary. One reason for this is for continuous monitoring of disinfectant control of Ciardia cysts. residual at an entry point to the ' . Some participants felt that distribution system. Systems serving minimum treatment requirements for - more than 10,000 persons should monitor small systems should be evaluated on a disinfectant residual in the distribution case-by-case basis but this assumed a system at the same frequency as ' ' history of compliance and that increased bacteriological sampling [suggested as '. monitoring and use of SPC will be done. guidance). ' ' . All new finished water reservoirs AnalyticalMethods and Sample should be required to have a cover. Non- Handling. The following recommendations were made relative to analytical methods and sampling: Participants concluded that the - mandatory policy should be developed for covering existing finished water reservoirs. Comments are solicited on all of the Asbeatoa . Thallium "Sulfate V* .'Beryllium . .. Copper "Cyanide ` " * Vanadium *' " t -1 - -" The National Academy of Sciences ,. ' ha3 reviewed the existing regulations and has made recommendations regarding the adequacy of the - regulations including suggestions on possible additions or deletions. The frequency and levels of occurrence of these inorganics in drinking water often vary regionally across the country; in-, some locations certain contaminants are\ found at levels of concern but in other..}. locations, the contaminants have seldom, been found. While many of the inorganics are natural contaminants cf ground waters, some inorganics may occur in drinking water as a result of uncontrolled hazardous waste sites and thus, future contamination of water supplies may result if sources are not contained. Numerous inorganic compounds, such bs lead, cadmium, and chromium, have been found, many times at relatively high levels, in leachates and runoff from hazardous waste sites. . These pose a potential threat to surface water quality but primarily to ground fermentation tube (FT) and membrane: filtration (MF) procedures are above recommendations produced by the Microbiological Standards water quality. Because of the slow movement and lack of self-cleansing apprbpriate for the enumeration of total Workshop.' coliforms; participants recognized that significant underestimates of coliform jlnorgariic Chemicals; . .. . . characteristics of ground water, once contaminated, the ground waters will ' . remain so for long periods of time. Other number occur with both procedures, and - The Interim Regulations contain MCLs such sources include contamination of suggested specific requirements be...... for the following inorganic chemicals: ground water with nitrate as a result of included in the NPDWR to attempt to ' application of fertilizer on croplands. minimize this problem. See the _ - Contaminant MCL.mg/1 Issues involving these contaminants .. "Proceeding" for more details. For SPC analysis, any of the procedures listed in Standard Methods ' or equivalent, using 46-hour incubation at 35'C. are acceptable. It was recommended that the .'current 30-hour maximum sample transport time be retained with some modifications. The regulation should specify that samples shall be analyzed as soon as possible, but no later than 30 hours after collection. Later samples should not be discarded , N.ifula (aa ____ 0.05. . 1. 0.010. 0.05. 0.05. 0.002. 10. 0.01. 0.05. 1.4 to 2.4, 6.mala. * . oo Monitoring and reporting requirements were also included in the Interim Regulations for sodium and ' include the frequency of occurrence, carcinogenicity, relative toxicity of different valence states, relative toxicity of inorganic vs. organic forms, adverse health effects vs. beneficial health effects or nutritional requirements, synergistic or antagonistic effects and . the availability and cost of treatment. , Comments are requested on each of these issues as they relate to each inorganic chemical as well as on specific issues raised in the discussions below of each compound. Commented are also CAP CO JEN 0010667 45512 Federal Register / Vol. 40,. No: 194 / Wednesday,' October 5, 1983 / Proposed Rules requested to provide comments on the and if RMCLs and MCLs should be set' was not taken into account. " ' '' * need for and levels for RMCLs and for separate valence states.. Carcinogenci, mutagenic and teratogenic MCLa for each contaminant, the health Barium.- Barium is a natural mineral ' potential was not considered. Research risk of exposure, effective treatment " end deposits appear to be concentrated is currently in progress to determine the methods and costs, and available . - ;. in the midwest. Virtually all cases on. effects of cadmium on the reproductive, monitoring techniques... . .. '_... .non-compliance with the Interim nervous and cardiovascular systems. Inorganic Chemicals in theInterim-- ' Regulations have resulted from barium -' in ground water-sources. - ''.v.- ''_ Regulations- ' Barium in drinking water was. The critical concentration of cadmium in _ the renal cortex necessary for the-. . ''5'" '' developmentofproteinuria needs to be Arsenic- Although, arsenic compounds included in the U.S.PHS stardards since- reinvestigated;' .; ' may occasionally contaminate water, -.j-; 1948. The MCL for barium of 1 mg/1 was- . The most effective treatment methods-1 sources as the result of industrial r; based'on projected effects on the.-1-} for cadmium'removal include lime and. ..' discharges or pesticide, use,. the:. peripheral nervous and cardiovascular-. excess lime softening when cadmium is;:" occurrence ofarsenic in drinking water systems. The derivation of the MCL was- " present ss a contaminant, inthe water.'.i'.- is usually the result.of ground waters from inhalation data..An assumption source. Cadmium levels resulting from .' V" being drawn from mineral forma tions'-.V was made regarding the absorption of- corrosion can be. reduced by >' containing natural arsenic'ores. The- barium into the blood stream from the-- ' , implementation of an effective corrosion ' ' areas affected include the southwest,'""';' gastrointestinal tract,'which is'.',' v:v..r.:.?j . control program, including pH.' \ northwest, northeast, and Alaska. reasonable for children but conservative adjustment;'calcium carbonate . ;v 'f1' - Arsenic occurs in both trivalent and" for adults-.The possible role of barium in-' stabilization or addjtion of.corrosion"'"' ''. t pentavalent states, as well as in organic drinking water in cardiovascular disease- inhibitors:'.... .r/.'' '` .' forms. Trivalent compounds are more ' , includinghypertensioiris a matter of Cadmium.in drinking.water has been.'. toxic than pentavelent compounds. The." controversy and conjecture. Several :=.. included in'the U.S..PHS standards since... pentavalent state appears to . ,'i ' aspects of barium toxicity are currently- 1962. The current drinking water ' j:'...' ^ ' predominate in foods,.particularly- v being investigated, including the ' standard is 0.010 mg/LThe. WHO seafood. -- : . gastrointestinal absorption rate3'and'.- , guideline level for cadmium-is 0:005 mg/.'.' Arsenic has been considered by. . health effects following ingestion".' certain researchers to be an etiological. .! Preliminary experimental findings have 1 The derivation of an MCL'for the-' - ,- - factor'in epidemiod'carcinoma of the . -'. skin and lungs and precancerqus dermal:, keratoses. At this time, there is not an. acceptable animal model' demonstrating. carcinogenic potential' of arsenic. Recent.' findings indicate that'scsenic may be a ; promotor of carcinogenesis rather than an initiator. Also, the carcinogenic risk' may be a-function of nutritional'factors."' No nutritional requirement for arsenic has been firmly established; however someauthorities consider that trace ' amounts of arsenic are "nutritionally, revealed that chronic,: low-level barium ' ingestion produces increased blood ' pressure and EKG abnormalities in rats. The: WHO has.not established a ' recommended guideline level for.. ' '_ -. barium^ " ' -- :* . Most treatmentmethods used'for-- water softening are effective, for barium removal.These- methods include;lime: '' softening.and ion exchange using-either natural greensand or synthetic- resins.. Reverse osmosis is-also extremely . effective for barium removal. Recent estimates of gastrointestinal NPDWR will entailconsideration of-.. many factors, including the-additive or , synergistic effects'ofcadmium and other- trace metals'.irt drinking water. Public comments-are-.requested om (1) the role -., of cadmium in reproductive, nervous. - t and cardiovascular dysfunctions; [2) the-; potential carcinogenic effects; [3) the . , importance of cadmium-from other . routes-of exposure relative to drinking .. water and (4)-monitoring requirements for corrosion-related cadmium in-... .- ... , drinking water. - " ' desirable". ' absorption rates and the results of Chromium. The occurrence of excess Ion exchange treatment usinganfon" experimental and epidemiological chromium in drinking wateris relatively exchange resins.'activatedalumina, studies indicatetbat the MCL for barium- bone char and reverse osmosis can . in the Interim Regulations needs to-be remove both trivalent'and pentavalent" ,' revised. The NAS-Safe Drinking 'Water- infrequent and the result of .. : contamination- of water sources or use of: chromates as corrosion inhibitors. . arsenic encountered in drinking water. ' Committee recommended that 4.7 mg/l. The MCL fortotal chromium (trivalent. sources. Lime softening iseffectfve for - provided an adequate margin of safety and hexavalent) was based on the '. " removingpentavatent arsenic but less . . based upon adult intake and exposure- - toxicity of hexavalent chromium.. effective for removing, trivalent'arsenic.: parameters, but did not consider the . Trivalent chromium.is relatively non- Activated alumina absorption has been.-' higher uptake efficiency and water toxic only very slightly soluble in water shown to be effective for arsenic . consumption rate-of children: Public ;' and is considered essential in man and - . removal from ground water sources. comment is requested on -.. / '' animals for efficient lipid, glucose and . . Arsenic &t drinking-water has been ..: gastrointestinal absorption rates and. protein metabolism. An MCL for includedin the U.S. PHS standards since cardiovascular effects of barium. chromium expressed only in terms of the 1942. The current MCL for arsenic of 0.05 Cadmium. The presence of cadmium " hexavalent form is complicated by the mg/1 was derived from toxicity . 1 ' in drinking water is normally the result likely conversion of trivalent to considerations other than - ' '" of corrosion of galvanized pipes and hexavalent chromium in drinking water . carcinogenicity. The World Health fittings. Also, cadmium-may Qrgani2jtaxs [WHO} guideline level for occasionally be present as the result of sources under oxidizing conditions, such as during chlorination- arsenic is also 0.05 mg/1. contamination of the water sources. Hexavalent chromium exerts adverse At this time, it is not possible to speculate whether the existing MCL for nrsenic should be altered from-that in the Interim Regulations. Public comment There are very few instances where water systems have exceeded the current MCL for cadmium.. The MCL for cadmium was based on effects on the renal,hepatic and gastrointestinal systems and the skin. Carcinogenic and mutagenic potential of this form of chromium has been shown. is requested upon the basis for the the intake necessary to ptoduce- - Trivalent chromium can be effectively RMCL: carcinogenicity vs. other effects, proteinuria; while a significant source of. removed from drinking water by nutritional requirements vs. health risk; intake could be cigarette smoking, this conventional coagulation techniques. / CAP CO JEN 0010668  Federal Register / Vol. 48, No. 194' / Wednesday. October 5, 1983 / Proposed Rules45515 ailments has not been correlated with thus are generally found only in Dietary molybdenum affects copper aluminum ingestion, but the apparent . individuals working in the antimony metabolism in many species. Data are accumulation of aluminum in the brains industries.'Most cardiovascular - available which suggest that copper andskelelons of dialysis patients has .. abnormalities (cardiac arrhythmias) depletion may result from molybdenum Become a cause for concern. ; _ - have been attributed to the consumption exposure of.as low as B0 pg/1 in-drinking Since alumimum in drinking water .. of pharmaceutical preparations water. In India, molybdenum has been frequently results from water treatment containing antimony. The latter are implicated in the formation of a recently with alum, the concentration of residual parasticides used to treat - ! identified bone-crippling disease. Genu aluminum could be minimized by schistosomiasis, bilharziasis-and.. ; valgum (knock-knee'd syndrome). The ! providing contols on the treatment '! leishmaniasis. However, patients with NAS has estimated the average dietary' .- process. Should severe restrictions be - :'i -pre-existing cardiac and pulmonary . molybdenum intake to be between 100 warrented, alternative coagulants could.,' I' conditions might find their ailments - .. and 4600 pg/day. At the same time, the be required. Activated alumina, which. exacerbated by exposure to waterborne NAS cautions that molybdenum should also contributes some aluminum to'-^. iij " antimony and thus become a group at not habitually exceed 500 pg/day. - -' drinking water, Is'.us'ed to remove a risk. Additional research is needed on. : Persons consuming a diet at the high end ' number of contaminants from drinking the health effects of antimony derived of the' range could possibly be at risk water. Cation exchange should'be !... from drinking water. " from molybdenum in drinking water. : J effective for removing aluminum from -Antimony exists in natural waters .'-Molybdenum is not removed to any V -. water, whether the'aluminum is from: . withvalences of three and five, as well great extent during conventional water;':', .'.natural sources or from water treatment!-' as in two organic forms, methylstibnic treatment processes. Molybdenum as In Drinking Water andHealth, Vol.,' and dimethylstibnic acids. Removal . molybdate could-be removed by anion IV. the NAS calculated a 7-day Health!.- treatment for the inorganic forms . : exchange, and reverse osmosisshould .. Advisory of 5 mg/I but did not calculate includes ion exchange and reverse '' be effective for either the cationic or any values for chronic exposure. The osmosis, while activated carbon should - anionic forms of molydenum. . WHO guideline level for aluminum is 0.2 . be effective for removal of the organic The NAS recommends a dietary : - - mg/1 on the basis of.aesthetic " **. forms. Antimony(V) is by far the most molybdenum intake of between 150 and considerations. Consideration ofany possibleMCL would involve evaluation, of relative exposure from drinking water. -. versus other sources, health effect' studies and control evaluations.-- Antimony. There is no current MCL. for antimony, but the development of an. MCL has been suggested on the basis of possible health risks. Antimony. tesembles arsenic both chemically and biologically and symptoms of acute and chronic toxicity from antimony closely resemble those induced by arsenic. The limited available occurrence data show that antimony has been found . ; most often in tap water-derived from -. -j abundant form in river waters.. EPA's "Ambient Water Quality ' . Criteria for Antimony" contains a criterion of 145 pg/1 for drinking water sources. The USSR has a limit of 50 pg/1 for antimony. The WHO has not - developed a guideline for antimony. The paucity of information on health effects attributable to the consumption of antimony from drinking water and tht0v data on antimony occurrence in drinking'"water do not seem to warrant the . establishment of primary drinking water regulations for antimony at this time. Molybdenum. On the basis of occurrence of molybdenum in some. 500 pg/day for adults. Some " - investigators recommend that drinking ' water molybdenum levels should not exceed 50 pg/1, but the need for an MCL is still under consideration. The WHO '' has not established a guideline level for molybdenum. In general it does not appear that the contribution of molybdenum from drinking water is . . .'significant, but high levels have been selected in drinking water in some 5 areas. ; Asbestos. This substance occurs frequently in drinking water both from natural mineral sources and from the surface sources, and while individual " surface waters, and on the basis of the degradation of asbestos-cement water ' samples have been reported to contain association of molybdenum intake with pipe in contact with aggressive water. as much as 90 mg/1, most reported . the incidence of gout, the establishment positive.samples contained less than 200 of the MCL has been suggested. While airborne asbestos is a recognized health hazard, the effect of asbestos pg/1. The average concentration of Molybdenum is commonly found in ingested from drinking water is unclear:-, positive samples of antimony in drinking ground and surface waters. However, The role of asbestos in the etiology of ;/ . water is probably in the order of a few - unless the water originates from a gastrointestinal cancer has been a ' }ig/l. Mining operations and leaching - processing or mining source, the matter of-scientific controversy. Many from plumbing systems (tin/antimony molybdenum concentrations of positive aspects of asbestos have been the solder) are possible sources of drinking samples are generally in the order of a subject of intense investigation, water contamination, although there are few pg/1. Isolated cases of high including the health effects of ingeslqd . only two antimony mining sites in the ' molybdenum drinking water . asbestos and the significance of U.S. and tin/antimony solder is not concentrations were reported in the asbestos exposure from asbestos- widely used. The total antimony proximity of open-pit uranium mines. cement pipe. The WHO has not contribution from food and drinking Aqueous effluents from such sources' as established a recommended action level water appears to be less than 100 fig per shale oil production and coal - for asbestos. day on the average. combustion may also introduce Asbestos in raw water sources can be Three primary health effects are molybdenum to the aquatic- removed by modified conventional associated with exposure to antimony at high doses: pulmonary irritation and its" consequences, dermatitis, and cardiovascular abnormalities. Toxicity environment Molybdenum is essential in the diet, ' as it is an integral part of five enzymes: aldehyde oxidase, sulfite oxidase, coagulation and filtering techniques. Filtration alone is ineffective because of the small size of the asbestos fibers. When the source of asbestos is the symptoms also include gastrointestinal nitrogenase. nitrate reductase and deterioration of asbestos-cement pipes upset, irritability, sleeplessness, fatigue, xanthine oxidase. However, some in contact with aggressive waters,. dizziness and muscular pains. The investigators have reported increased calcium carbonate saturation of the pulmonary and dermal problems are blood and uric acid levels as the result water is effective. Other treatments mostly related to airborne antimony and of increased molybdenum intake. showing promise for inhibiting CAP CO JEN 0010669 45516 Federal Register / Vol. 48,: No. 194 / Wednesday, October 5, 1983 / Proposed Rules' -deterioration of asbestos-cement pipe drinking water. While the hazard to Sodium: Sodium is ubiquitous in include the use of zinc corrosion . . health from copper appears to be small drinking water and the levels detected inhibitors, pH adjustment and lime for the general population, there are a vary from 0.2 to 260 mg/l or more in stabilization........; .,__ few people who cannot tolerate even ' public systems and 0.2 to 622 mg/l in Consideration of an MCL for asbestos normal amounts of copper in the diet. individual wells, according to the most fibers in drinking water involves factors These people are those suffering from - recent survey. However, food is the ranging from analytical detection and ./ ` Wilson's disease, an inherited - major source of sodium intake in the; '- . counting methods to establishment of a'? autosomal recessive trait characterized ' vast majority of cases.': ;-v dose-response relationship; The.latter-.i rt by a disorder in copper metabolism . : The available evidence indicates that 'depends on the outcome of animal. . which can lead to hepatic cirrhosis and ' excessive intake contributes to an age- \ feeding studies, the most recent of whiejfto necrosis and sclerosis of the corpus related increase in hypertension in .' v have not shown any.-adverse health*.'^'; .--straitum. A few people may also have a.-" genetically susceptible individuals. The'i-. : effects from ingestion. An intensive -.'.V: deficiency of glucose phosphate National Academy of Sciences has; " seminar on this subject was conducted dehydrogenase which is believed to estimated that about 15 percent to 20 by EPA in October WBZ^The results of cause hypersensitivity to copper. percent of the population are'at the risk the seminar will be.publi$hed shortly.. ^ Since the occurrence of copper in ' of developing hypertension; There is The epidemiology-data.on the drinking water is usually a result of also a small segment of the population':""'-1' Occurrence of ga stroiritestirial' tfac't '.j-'^v corrosion, techniques for reducing the'-:-..- who are on severely restricted diets for " pcaenrscoe_nr_sa_.ma_po_pn_eg_aoris_c._ct_ou_pb_ae-t'.ti1ho_en_aml_loy_se.txrpeole_s_veadn'.t'?^ ; ' corrosivity of the drinking water are effective in limiting the presence of V ' . various medical reasons and who must limit their total sodium intake.-'-'.' "" _. - issue.relating to risks from ingestiori:^:/ _ copper. The EPA SMCL and the WHO. " Development of an MCL has been -3 - '. .-" from drinking water:' , ~-'T~ r SGunlifranttee. fSinullffate is mcurrrroenntttluy included.. ,, guideline action level for copper are 1.0 ' mg/I based on taste considerations, but suggested but since food is the major . - source of sodium intake and because of ; in the secondary drinking water-. '' development of primary drinking water the difficulty and cost of removing . . . regulations because of its effect on the regulations has been suggested based\ .sodium from water, the regulation of the taste of drinking water. However,-.'":-..'- upon health considerations. ; sodium content of drinking water . `: sulfate is a common water contaminant, Vanadium. Vanadium occurs in both : appears to be impractical. Some recent / and in some cases it occurs at : . . ground and surface water.supplies, with studies using drinking water sodium as a concentrations high enough to cause the highest concentrations found near - ' control variable have suggested slight laxative effects, particularly in those hot uranium-vanadium mining and milling ' blood pressure increases in some groups: ' acclimated to use of high-sulfate waters. operations or near industrial operations. related to sodium concentration.' .. Concentrations as high as 2,000 mg/1 The source of vanadium in the latter have been found in some public water instances is fossil fuels which frequently systems. '. : : ' '- have high vanadium contents. Although Sulfate has been "suspected-as a data are limited, the mean concentration contributing factor in the formation of .^X-anadium in tap water samples ' . - various organ or duct calculi, but .-C^appears to be in the range of a few pg/1. ' evidence establishing a relationship."' *^*J,*Estimates of daily intake of vanadium riween the formation of these calculi from food and water average about 116 d sulfate concentrations in drinking jxg/day with intake from drinking water wafer is lacking. Sulfate is extremely from 4 to 7 percent of the intake from - difficult to remove from drinking water. ' food. Air might contribute an additional Anion exchange and reverse osmosis / maximum amount of 9 pg/day. ' are reasonably effective. The WHO has Chronic respiratory exposure to a"guideline level for sulfate at 400 mg/l vanadium may decrease cholesterol . -- based essentially on taste. The synthesis, uncouple oxidative " secondary MCL (SMCL) for sulfate is ' phosphorylationjn liver mitochondria, 250 mg/l. ", and decrease urinary excretion of 5- - Copper. Copper is currently regulated hydroxyindoleacetic acid, with transient . . Sodium is probably the.most difficult substance to remove from drinking - water. Only the most rigorous treatment . processes, such as distillation, reverse - osmosis and deionization will remove ' - sodium. It should be noted that virtually all other substances present in the water will be removed by these processes, and that reconstitution of the water . .. . . following treatment will be necessary. for the water to be acceptable on the basis of taste, corrosivity and desirable .. mineral content. - , .. ; . .. The current primary drinking water regulations contain a monitoring and: . reporting requirement for sodium. The dissemination of information on the In the secondary drinking water - - bilirubinemia and albuminuria. There is---- sodium content of drinking water should regulations because of its effect on taste - also some evidence that vanadium , - enable those who must or wish to limit y, of drinking water. It is.comnionly found. causes the appearance of scattered their sodium intake to adjust their diets ' in drinking water from corrosion of copper pipes. \ allergy-like eczematos skin lesions. - -. `according to their needs. The WHO J; ' 'However, there is no evidence of any - recommended action level for sodium is " Copper is an essential nutrient, but " ' chronic oral toxicity, probably because 200 mg/l based on taste. Comment is -. there is no evidence of copper " i:-"-' . ingested vanadium is poorly absorbed.' requested on the evidence relating de&iesMy iot the LL&. population except Vanadium may have nutritional drinking water concentrations and . for isolated" cases in patients maintained significance, and it appears possible that elevation of blood pressure, and the - by total parenteral nutrition. Copper is ; the contribution of vanadium from .- significance of contribution of sodium toxic to monogastric animals when V - drinking water to the daily intake may from drinking water to the overall ingested in quantities that are 40 to 135 be beneficial. ' " exposure and the need for the MCL. times greater than their respective The WHO has not established a - Nickel. Nickel is seldom observed in requirements. Toxic effects from" - recommended action level for. fresh water. Natural nickel salts tend to elevated drinking water levels have -. vanadium. The beneficial aspects of hydrolyze to insoluble hydrolysates in been reported especially for infants. vanadium intake and the absence of water, so any nickel in surface or ground Copper imparts an unpleasant taste to evidence of chronic oral toxicity do not waters would likely be present in small drinking water, which, along with an . appear to support the development of amounts unless the presence of nickel . emetic effect, serves to limit the amount primary drinking water regulations for was due to industrial pollution. The of copper which can be ingested from vanadium. . - limited available data show that the CAP CO JEN 0010670 .Federal Register / Vol. 40. No. 194 / Wednesday, October 5, 1983 / Proposed Rules 45517 concentration of nickel in tap water . of cadmium and lead. Some segments'of leaching these compounds for piping usually does not exceed 20 pg/1 and is . the population of the United States may materials, it is very likely that other likely to be present at average be marginally zinc-deficient. compounds of health concern are also concentrations of a few pg/l or less. The Treatment for zinc reduction usually * leaching from the pipes. Further, a average oral intake of nickel has been is limited to processes which reduce number of epidemiological studies reported to be 300 to 600 pg/day. corrosivity of water, since the presence, Indicate that there may be an increased Inhalation exposure ranges from 2.4 pg/'. of zinc in drinking water is usually the incidence of cardiovascular disease person/day. and the average intake result of corrosion. associated (however, this subject is still from water is probably less than that''... The SMCL for zinc is 5.0 pg/1 and the . under investigation). ... from air. . /' y.1; i WHO recommends that zinc be kept For many chemicals of concern, Therefore, based on average food! ; 'below 5.0 pg/1 for aesthetic reasons. - .' corrosion is the major source of drinking water, and air concentrations, most Comment is requested on the need for water exposure. For example, lead is drinking water contributes a very small'? an MCL for zinc. . proportion of the daily nickel intake..'- . ' ,' .......... .. . , ' . Nickel salts, like the salts of copper arid <Corrpsiorv- .. a.-..-. Lr-.-i-tih . seldom found in the water source but is ifyU commonly found in tap waters that are ! corrosive and are delivered through a. zinc, exert their toxic action mainly by' ' gastrointestinal irritation iand not by ' ' inherent toxicity. Nickel ha3 long been The Interim Regulations include ' requirements to (1) determine the : presence of specific materials in' .1 . " s distribution system using lead piping material or if lead is used bs a - ,' constitutent of solders used to join non- . .' thought to be relatively'non-toxic,;';.'. distribution systems and (2) to monitor although nickel exposure has been7. V for characteristics of corrosivity of the associated with .the development of '. - water.'The water supplier must occupationally related cancers of the- determine and report whether the . lungs, larnyx and nasal cavity. Contact- following materials of construction are' dermatitis from exposure to nickel is present in the distribution system; . well known. Quantities of nickel as .1. Lead used in piping, caulking, minute as 58.7 pg/1 have produced interior lining of distribution mains,, exzema in sensitized, susceptible alloys and home plumbing. ; individuals. Dietary'nickel can ' 2. Copper used in piping and alloys, aggravate nickel dermatitis. Apparently service lines, and home plumbing. ` insoluble nickel compounds pass rather " 3. Galvanized piping, service lines, quickly through the gastrointestinal tract' and home plumbing. ; . and have limited absorption: - - ' 4. Ferrous piping materials such as Conventional water treatment- - ; cast iron and steel. :' processes (e.g., use of alum, lime or soda ' 5..'Asbestos cement pipe:?. \. ash) do not appear to be effective for removal of nickel. Ion exchange and ' reverse osmosis would likely be The objective of obtaining this ' information regarding water quality and the presence of specific materials of : . ' ` v lead piping materials. Normal monitoring requirements, intended to determine the extent of contamination of the source water, are unlikely to characterize the exposure to high leve'3 of lead that are associated with toad piping materials and solders that are. expected to the distributed unequally : throughout the distribution system. Control of corrosion can be accomplished by a number_of measures Including pH adjustment, controlled alkalinity, addition of corrosion inhibitors or lime stabilization. In setting the corrosion monitoring and reporting requirements in the Interim Regulations, consideration was given to setting an MCL for one or more effective. - . * construction was to enable.the primary of the various corrosivity indices, ' - The WHO has not established a' - enforcement agency to determine which including the Aggressive Index (AI), the recommended action level for nickel. water supply system should initiate Ryznar Index (RI) and the Langelier The NAS does not view nickel in - corrosion control measures. Index (LI). The indices are not a direct drinking water in terms of current levels --- -Results of two independent studies' v measure of the corrosivity of the water as a cause for concern. In view of the estimate that approximately 16 percent but rather are indicators of the calcium usually low concentations of nickel in of the public water systems in the '; carbonate stability which may be used drinking water and in view' of the United States distribute waters that are to predict whether or not a calcium limited health effects aspects, the highly aggressive (U<--2.0) (LI: . carbonate (CaCCh) layer may be :' establishment or a limit for nickel in Langelier Index), while an additional 52 deposited and maintained on pipe drinking water may not be warranted. percent distribute moderately aggressive surfaces to protect against corrosion. At Zinc. Zinc is currently regulated in the waters (--2.0 <LI <0.0). It is also that time these indices were determined secondary drinking water regulations known that only a limited number of not to be ideal as a determinant for based upon taste considerations. Zinc : these systems have instituted corrosion corrosive characteristics of drinking occurrence in drinking water is most control measures. water in all instances. frequently due to the corrosion of Corrosion is a very significant concern The approach being considered for the galvanized iron pipe and fittings. Some- not'only'affecting the aesthetic quality NPDWR is to set specific monitoring very high zinc concentrations have been of the water but having a serious requirements for corrosion by-products,'' noted when catchment systems made of economic impact and posing health such as lead and cadmium, that would galvanized iron were used to collect rain implication. Corrosion byproducts address the problems of obtaining water for drinking purposes. Zinc is containing materials such as lead and representative samples to assess water relatively non-toxic and is an essential cadium have been associated with quality. The definition of "compliance", trace element. A wide margin of safety serious risks to the health of consumers with an MCL will be revised to assure . exists between normal intake from the . of drinking water. In addition, by that everaging.will not permit portions diet and the amount likely to cause oral products of corrosion commonly include of a water supply to exceed an MCL on ' toxicity. At drinking water such compounds as zinc, iron and a continuing basis. Specifically, systems concentrations high enough to cause copper for which SMCLs have been set that have known corrosive water or gastrointestinal disturbances, zinc in the NSDWR; occurrence of these which have piping materials that are '. would impart a strong astringent taste compounds, as a result of corrosion, susceptiable to corrosion will be and milky appearance to the water. Zinc should be considered indicators of required to take sufficient samples in . . interacts with other trace metals, and possible deterioration of the distribution their distribution systems so that the has a protective action against toxicity . systems. Also, if corrosive waters are . State can be assured that the MCLs for CAPCO JEN 0010671 45513Federal Register / Vol. 48. No. 194 / Wednesday, October 5, 1983 / Proposed Rules die corrosion by-products will riqt be1 Atrarine : risk ever a lifetime. The Carcinogen' bcceeded in various parts of the V 'y -'f- Phthslates 1 :.- - distifbotion system. Commentsare requested on this approach and on what ^ Acrylamide' Dibromochloropropane (DBCP) 1,2-Dichloropropane specific monitoring requirements should' Pentachlorophenol . ,. beset.Also, any available new - Pichloram ... information on theuse'of corrosion"-* -1 Dinoseb ' '" indices is reques(ed^~rf"i--',*-;""r--:-;??^.; Atachlor ; -' ' Ethylene dibromide " Synthetic Organic Chemicals (SOCs) ., Epichlorohydrin .Hh^BriSesfflai Regulations contain MCLs Dibromomethane . forj&e following organic chemicals: : Toluene '.'Xylene ; ' .j.v- Contaminant '* .; * Interim regulation* -.Adipates . - -.WHO Recommend'1 Hexachlorocyclopentadiene . MCC mg/I. ed Limit 2,3,7,8-TCDD [Dioxin) . ;; ~. Assessment Group recently recalculated their excess cancer risk estimates for ; lindane. Assuming consumption of 2 liters of water per day, a concentration level of 32 ng/1 was estimated to result ,in a one in a million risk over a lifetime. ' The NAS felt that there were ... insufficient data'on which to basean . estimate of cancer risk for endrin. For ' ^methoxychlor and toxaphene, the NAS ... Strived ADIs of 0.1 mg/kg/day and' . *'0.00125 mg/kg/day,'respectively.. '. It is important to note that NAS established the ADI for toxaphene. : .; ^ 0.002 Inclusion of specific SOCs on the ' '.; before the NCI bioassays in rats and *-*-0.004 0.003'* above list was based upon the .' ; ' mice were completed. Under the i_n 0.005 - :. *O0.030' occurrence of the SOC in drinking water lV`- * `0.1 *" ' J3A ' ; and the potential health effects of : ' conditions of testing, toxaphene was ; found to be carcinogenic in mice of both *-::;:\o.oi ` .0.10 - *0.030. ' exposure to that SOC. The pesticides included in the above list have either , sexes (Increased incidence of ...; hepatocellular carcinoma). The tests'. . *ftr cMofOorm only. * * i ............ / vl- These organic chemical MCLs, with..- the exception of trihalomethanes and theiar associated monitoring .. '' requirements, are being reviewed at this ' time for possible inclusion in the ,. NPDWR.The total trihalomethane (TTHM) regulations have only recently ,.' ...been detected in drinking water, are ' registered for use in or around drinking '. water, or are used in such a manner that the potential exists for entering drinking water supplies. Inclusion in the above list does not necessarily mean that \ ' regulations will be developed for the SOC but that these are SOCs currently . ' results also suggested carginogenicity of ' toxaphene for the thyroid of rats of both, sexes. .. . ;'. - ;' ' ' .. Chlorophenoxy Herbicides. The NAS. -; also derived ADIs for the two .... chlorophenoxy herbicides, 2,4-D and ;: 2,4,5-TP. These were 0.0125 end 0.00075 mg/kg/day, respectively.The food . taken effect, and then only for a limited' | being considered; other SOCs not listed segment of public water systems; it, may also be considered and included in additive tolerance level established for' .2.4-D in water is 0.1 mg/1, identical to v would be premature to consider ' ' -'' ''' the NPDWR. Determination of which the MCL for this substance in the.. : . revisaoss at this time.The'entire area of . -SOCs should be included in the NPDWR Interim Regulations. -. ; ..; -.?: - ..!; diaroffectSoa by-products and alternative will be based upon an analysis of the Other Synthetic Organic Chemicals disinfectants will be considered at a ' significance of potential human (SOCs) Under Consideration . lalra-diate. Experience must be gained , -! exposure, associated health effects of the- fall implementation of the . regulations. Also, further health' ` exposure, and other pertinent factors. - Other Pesticides. A number of other Brief discussions of the pesticides pesticides are registered by EPA for <fcts data are required in order to '.. 1 included in the Interim Regulations are uses which may result in their presence evaluate the potential health risks to provided below and are followed by a in drinking water sources. During the ' ' these substances. ' discussion of several of the other SOCs registration process under the Federal In the U.S., establishment of limits for under consideration....... , ' - . ', .' : Insecticide, Fungicide and Rodenticide '-- pesticides fn drinking water began with the advisory groups engaged in revising thelS62 Public Health Service drinking Organic Chemicals in the Interim Regulations -. . ; Act (FIFRA), and acceptable residue : limit in drinking water is determined for ' each of the aquatic use pesticides, but '. water standards. Virtually no cases of Chlorinated Hydrocarbon. not for other pesticides. Depending upon non-compliance with the current MCLs " Insecticides. The Interim Regulations the quality of the available data, these have been, reported. The USSR's contain MCLs for endrin, lindane, allowable limits may be of a permanent diisffifflg water standards [1970) listed a methoxychlor and toxaphene. The NAS, - or temporary nature. Allowable limits nianEsssrof these pesticides among the in Dinking Water andHealth (1977), " . for certain of the aquatic use pesticides apprmfciafely 200 organic chemicals for .' ' considered lindane to be an animal ore listed below:-' ' ' ' - which limits were set. _ carcinogen and endrin to be a suspected A number of other synthetic organic " - animal carcinogen. The NAS derived a FIFRA chemicals ara being considered for : .. risk estimate for lindane of 5.6 to ' * Compound derived acceptable ADI (p*f NAS) inclusion in the NPDWR including a *. ,13X10*5per microgram per liter for mnnfrsircSregistered pesticides. These lifetime exposure. This corresponds to a fcmrt fcsdUdfe:- A'.&carb Chlcrriane Dabpon Diquat Eadolhall "V concentration level of 77 to 180 nanograms per liter (ng/1) at the 10" ............. . '-riskrate. ` ..-The EPA Ca'rcingen Assessment i ' .-' Group derived excess cancer risk ' estimates for exposure to lindane in ___ ______ Simaaine `................... 0.2 ppm_____ 0.1 ppm.-- 0.2 ppm4^. 0.1 ppm___ 0 5 ppm_____ 021$ mg/g/day. * Temporary hrr.it. Gfcpftosnte. - . ambient water (U.S. EPA, 1980). Other pesticides which have been ' ' Assuming the ingestion of two liters of reported to occur, at least occasionally, Uti^rotJitoroelhana Vjisl'e Siirsiine , drinking water/day and 6.5 grams/day of contaminated fish and seafood, a in drinking water sources include chlordane, aldicarb, carbofuran, PAKs water concentration of 18.6 ng/1 was pentachlorophenol, PC0J - estimated to yield a one in one million dibromochloropropane (DBCP). dinoseb. CAP CO JEN 0010672 Federal Register / Vol: 48, No. 194 / Wednesday, October 5, 1983 / Proposed Rules 45521 The analytical methods for detecting VII. Request for Public Comments and quantifying radionuclides. Monitoring requirements for radionuclides. Public comments and information on all aspects of the issues presented in this ANPRM are requested to assist EPA The treatment for removing in determining the appropriate radionuclides from drinking water, its regulatory approaches and specific . .cost and general availability. requirements of the NPDWR. Supporting Waste management practices for information is requested for any removal ofradionuclides from drinking comments provided. For microbiological, .water. ...... . ' inorganic, organic, and radionuclide Methodology for protecting against multiple exposure..'.1 ' .VI. References '" .'s ' . ; contaminants, the following questions are being'examined.. .."'What criteria should be used to determine which contaminants should , . The following references are. available " be in each category? What contaminants from the addresses listed at the ; "should be included in Category I, beginning of this notice. . Category II, and Category HI as described? Assessment ofMicrobiology and Turbidity . Standards for Drinking Water, EPA, ODVV, 1983. National Interim Primary Drinking Water Is waiving certain MCLs when . susceptible populations are not affected an appropriate approach? For which Regulations. Amendment Trihalomethanes,. contaminants? Could this be used as on 48FR8406. February28.1983.' . ... > criteria for determining which Category Fluoride: Response to Petition from South would be appropriate for certain Carolina. 46 PR SS345, December 1.1981. contaminants? . . .' , Ronald Reagan, Executive Order 12291, 46 FR What level should be established 13193. Feb. 19.1981. -, , Safe Drinking Water Act Reauthorization, 47. - FR 670. January 6.1982. "Small Systems Strategy" 45 FR 40222. June 13.1980. for each RMCL? *. ; --What safety factors should be used in ' conjunction with chronic toxicity data in RMCLs for non-carcinogens? The following documents are available from the sources indicated: --Is using the ADI an appropriate method for establishing RMCLs for ' - non-carcinogens? National Interim Primary Drinking Water Regulations. NT1S, Accession No. PB 267530." ' -ng Water and Health. Vols. 1. II, III, IV. v V. National Academy of Sciences. --By what method should RMCLs be set for carcinogens? What level should be established for each MCL? Washington, D.C. Manual of Treatment Techniques for Meeting fee Interim Primary Drinking Water . Regulations, EPA ORD. MERL, Water Supply Research Division. Cincinnati. Ohio 45260. Evaluation of the Microbiology Standards for Drinking Water. NT1S, Accession No. PB 297119L --What criteria should be used to identify Generally Available Technology (GATJ under the SDWA? Engineering and technical feasibility factors? What factors affect "reasonble" cost determinations? What is a reasonable cost for the consumer? --How should system size, water quality and other factors be incorporated in the GAT? Should .. "n;m-conventional" solutions such as bottled water and point-of-use treatment devices be considered acceptable means for achieving compliance? , .. ' What requirements should be set for monitoring for each type of . contaminant? - ' --What frequency of monitoring would ' 'provide.adequate measurement of , ; ' water quality within the feasible means of water systems?- , --Which analytical methods are most `. reliable and what are the costs involved? ' . --What limits of measurement accuracy and precision should be set for each analytical method? What reporting requirements should be established to provide an efficient means of determining compliance while minimizing paper work burdens on public water systems and State programs? A public meeting and four public workshops will be held for the interested public to comment and provide information and data on the regulatory approaches and other issues presented here. Dates and locations of the meeting and workshops are provided * in the Dates section of this notice. ' List of Subjects in 80 CFR Part 141 Chemicals, Intergovernmental relations, Radiation protection, Reporting and recordkeeping requirements, Water supply. Dated: September 27,19B3. William Ruckelshaus, Adnu'jiislrctor. (FR Doc. 63-Z71J4 Flint 10-4-63:8 43 amj BflUKQ CODE 6380-SO-M CAP CO JEN 0010673