ML23153A019

PR-020 - 59FR09146 - Disposal of Radioactive Material by Release Into Sanitary Sewer Systems

ML23153A019
Person / Time
Issue date:	02/25/1994
From:	Chilk S NRC/SECY
To:
References
PR-020, 59FR09146
Download: ML23153A019 (1)

Text

ADAMS Template: SECY-067 DOCUMENT DATE: 02/25/1994 TITLE: PR-020 - 59FR09146 - DISPOSAL OF RADIOACTIVE MATERIAL BY RELEASE INTO SANITARY SEWER SYSTEMS CASE

REFERENCE:

PR-020 59FR09146 KEYWORD: RULEMAKING COMMENTS Document Sensitivity: Non-sensitive - SUNSI Review Complete

DOCKET NO. PR-020 (59FR09146)

In the Matter of DISPOSAL OF RADIOACTIVE MATERIAL BY RELEASE INTO SANITARY SEWER SYSTEMS DATE DATE OF TITLE OR DOCKETED DOCUMENT DESCRIPTION OF DOCUMENT

- 02/22/94 02/18/94 FEDERAL REGISTER NOTICE - PROPOSED RULE 03/22/94 03/17/94 COMMENT OF NAT HENDRICKS ( 1) 04/06/94 03/30/94 COMMENT OF ALAN M. JACKSON ( 2) 04/22/94 04/22/94 COMMENT OF RAY PAQUETTS ( 3) 05/02/94 05/02/94 COMMENT OF IMAGE AMERICA (TED BENNETT) ( 4) 05/05/94 04/26/94 COMMENT OF COMMITTEE TO BRIDGE THE GAP (JOSEPH K. LYOU) ( 5) 05/17/94 05/13/94 COMMENT OF UCLA SCHOOL OF MEDICINE (CAROLS. MARCUS) ( 6) 05/17/94 05/06/94 COMMENT OF SOUTHWESTERN MEDICAL SCHOOL UNIV TEXAS

- (FREDERICK J. BONTE) ( 7) 05/18/94 05/13/94 COMMENT OF INTERSTATE NUCLEAR SERVICES (MICHAEL J. BOVINO) ( 8) 05/20/94 05/12/94 COMMENT OF UNIV OF CALIFORNIA, BERKELEY (JOSEPH CERNY) ( 9) 05/20/94 05/16/94 COMMENT OF EAST BAY MUNICIPAL UTILITY DISTRICT (THOMAS C. PAULSON) ( 10) 05/23/94 05/13/94 COMMENT OF ROEDIGE PITTSBURGH, INC.

(NORMAN W. TESLIK) ( 11) 05/24/94 05/20/94 COMMENT OF CHARM SCIENCES INC. (DAVID R. LEGG) ( 12) 05/24/94 05/20/94 COMMENT OF THE ENZYME CENTER (DAVID R. LEGG) ( 13) 05/24/94 05/20/94 COMMENT OF BOSTON UNIVERSITY MEDICAL CENTER (VICTOR EVDOKIMOFF) ( 14) 05/25/94 05/24/94 COMMENT OF SAINT BARNABAS MEDICAL CENTER (LETTY G. LUTZKER) ( 15)

DOCKET NO. PR-020 (59FR09146)

DATE DATE OF TITLE OR DOCKETED DOCUMENT DESCRIPTION OF DOCUMENT 05/25/94 05/24/94 COMMENT OF DEPT OF VETERANS AFFAIRS (DONALD R. SAXTON) ( 16) 05/25/94 05/24/94 COMMENT OF ONCOGENE SCIENCE (DAVIDE. HILL) ( 17) 05/26/94 05/26/94 COMMENT OF OHIO RADIOACTIVE MATERIALS USERS GROUP (TIMOTHY A. WALKER) ( 18) 05/26/94 05/24/94 COMMENT OF CITY OF OAK RIDGE (GARY M. CINDER) ( 19) 05/26/94 05/24/94 COMMENT OF THE DU PONT MERCK PHARMACEUTICAL CO.

(DENNIS DUMAS) ( 20) 05/26/94 05/25/94 COMMENT OF ELI LILLY AND COMPANY (MARTHA CARTER BHATTI) ( 21) 05/26/94 05/25/94 COMMENT OF AMERICAN COLLEGE OF NUCLEAR PHYSICIANS (WM MCCARTNEY/RICHARD REBA) ( 22) 05/26/94 05/25/94 COMMENT OF THE UNIVERSITY OF TEXAS SYSTEM (CAROLYN H. WRIGHT) ( 23) 05/26/94 05/25/94 COMMENT OF GENETICS INSTITUTE (DALE BLANK) ( 24) 05/27/94 05/20/94 COMMENT OF SAINT BARNABAS MEDICAL CENTER (IRA M. GARELICK) ( 25) 05/27/94 05/23/94 COMMENT OF JORDAN HOSPITAL INC. (DONNAL PECHALONIS) ( 26) 05/27/94 05/25/94 COMMENT OF NEW YORK STATE ENERGY OFFICE (EUGENE J. GLEASON) ( 27) 05/31/94 05/20/94 COMMENT OF BRIGHAM AND WOMEN'S HOSPITAL (FRANK P. CASTRONOVO, JR.) ( 28) 05/31/94 05/23/94 COMMENT OF WALTHAM WESTON HOSPITAL & MEDICAL CENTER (D. MCCARTY/S. LEVITSKY) ( 29) 05/31/94 05/24/94 COMMENT OF SPAULDING REHABILITATION HOSPITAL (ANNA NEWBERG) ( 30) 05/31/94 05/23/94 COMMENT OF SIERRA CLUB (CMTE ON RADIATION &ENVIRONMENT) ( 31) 05/31/94 05/16/94 COMMENT o*F PAUL LAVELY ( 32) 05/31/94 05/19/94 COMMENT OF PECO ENERGY COMPANY (G. A. HUNGER, JR.) ( 33) 05/31/94 05/20/94 COMMENT OF TEXAS DEPT OF HEALTH (RICHARD A. RATLIFF) ( 34)

DOCKET NO. PR-020 (59FR09146)

DATE DATE OF TITLE OR DOCKETED DOCUMENT DESCRIPTION OF DOCUMENT 05/31/94 05/23/94 COMMENT OF BEVERLY HOSPITAL (JAMS H. CHAFEY) ( 35) 05/31/94 05/24/94 COMMENT OF HYBRITECH INCORPORATED (STEVE BURSIK) ( 36) 05/31/94 05/24/94 COMMENT OF PROTEIN ENGINEERING CORPORATION (RACHEL B. KENT) ( 37) 05/31/94 05/26/94 COMMENT OF WESTINGHOUSE ELECTRIC CORPORATION (A. T. SABO) ( 39) 05/31/94 05/31/94 COMMENT OF FLORIDA POWER &LIGHT CO. (W. H. BOHLKE) ( 40) 05/31/94 05/26/94 COMMENT OF US ENVIRONMENTAL PROTECTION AGENCY (RICHARD E. SANDERSON) ( 41) 05/31/94 05/31/94 COMMENT OF NUCLEAR INFORMATION & RESOURCE SERVICE (NIRS) ( 42) 05/31/94 05/26/94 COMMENT OF STATE OF ILLINOIS DEPT NUCLEAR SAFETY (STEVEN C. COLLINS) ( 43) 05/31/94 05/26/94 COMMENT OF BROCKTON HOSPITAL (CHRIS CONSTANTINOU) ( 44) 05/31/94 05/23/94 COMMENT OF GENZYME CORPORATION (RICHARD MATTILA) ( 45) 06/01/94 05/25/94 COMMENT OF OCULON CORPORATION (OCULON CORPORATION) ( 38) 06/01/94 05/18/94 COMMENT OF MD ANDERSON CANCER CENTER (M. E. MORTON) ( 46) 06/01/94 05/20/94 COMMENT OF ENVIRONMENTAL COALITION ON NUCLEAR POWER (JUDITH H. JOHNSRUD) ( 47) 06/01/94 05/23/94 COMMENT OF NEW ENGLAND MEDICAL CENTER (F. X. MASSE) ( 48) 06/01/94 05/23/94 COMMENT OF MITOTIX INCORPORATED (GIULIO F. DRAETTA) ( 49) 06/01/94 05/23/94 COMMENT OF MIT (F. X. MASSE) ( 50) 06/01/94 05/24/94 COMMENT OF NEW ENGLAND REGIONAL NEWBORN SCREENING (MARVIN L. MITCHELL) ( 51) 06/01/94 05/24/94 COMMENT OF HALE HOSPITAL (KIRWAN T. MACMILLAN) ( 52) 06/01/94 05/25/94 COMMENT OF TUFTS UNIVERSITY (JUNE R. APRILLE) ( 53) 06/01/94 05/25/94 COMMENT OF BIRGHAM AND WOMEN'S HOSPITAL (DAVIDE. DRUM) ( 54) 06/01/94 05/25/94 COMMENT OF TUFTS UNIVERSITY (ACACIA ALCIVAR-WARREN) ( 55)

DOCKET NO. PR-020 (59FR09146)

DATE DATE OF TITLE OR DOCKETED DOCUMENT DESCRIPTION OF DOCUMENT 06/01/94 05/25/94 COMMENT OF MERCY HOSPITAL (CHARLES C. KEOGH) ( 56) 06/01/94 05/25/94 COMMENT OF MERCK RESEARCH LABORATORIES (EDWIN A. WURTZ) ( 57) 06/02/94 05/18/94 COMMENT OF CORAR (LEONARD R. SMITH) ( 58) 06/06/94 06/02/94 COMMENT OF NATIONAL INSTITUTES OF HEALTH (WILLIAM J. WALKER, PH.D.) ( 59) 06/07/94 05/05/94 COMMENT OF JERRY L. PETTIS MEMORIAL VETERANS' HOSP.

(J.G. LLAURADO, M.D., CHIEF) ( 60) 06/07/94 05/24/94 COMMENT OF GOOD SAMARITAN MEDICAL CENTER (R.A. NEBESAR, MD/J.T. REILLY, CNMT) ( 61) 06/07/94 05/25/94 COMMENT OF WHIDDEN MEMORIAL HOSPITAL (R.T. FRANCE/T. ARANA, M.D.) ( 62) 06/07/94 05/26/94 COMMENT OF ASSOC. OF METROPOLITAN SEWERAGE AGENCIES (SAMUEL J. HADEED, DIRECTOR) ( 63) 06/08/94 05/19/94 COMMENT OF NORTHEAST OHIO REGIONAL SEWER DISTRICT (ERWIN J. ODEAL, EXECUTIVE DIRECTOR) ( 64) 06/08/94 06/01/94 COMMENT OF LAWRENCE MEMORIAL HOSPITAL OF MEDFORD (GWENDOLYN B. NICHOLS, M.D.) ( 65) 06/08/94 06/02/94 COMMENT OF HEALTH PHYSICS ASSOCIATES, INC.

(ANTHONY LAMASTRA) ( 66) 06/08/94 06/02/94 COMMENT OF VA MEDICAL CENTER/ OUTPATIENT CLINICS (SMITH JENKINS, JR.) ( 67) 06/09/94 06/03/94 COMMENT OF ADDISON GILBERT HOSPITAL (DIANE V. JOHNSON, RT(N)) ( 68) 06/09/94 05/26/94 COMMENT OF ERIC BOELDT, CHP ( 69) 06/20/94 06/16/94 COMMENT OF METROPOLITAN WASTE CONTROL COMMISSION (LEO H. HERMES, P.E.) ( 70) 06/21/94 06/13/94 COMMENT OF DEPARTMENT OF ENERGY (RAYMOND F. PELLETIER, DIRECTOR) ( 71) 07/11/94 07/07/94 COMMENT OF KAISER FOUNDATION HEALTH PLAN, INC.

(MARKS. ZEMELMAN, COUNSEL) ( 72) 07/18/94 07/13/94 COMMENT OF CITY OF COLUMBUS, DEPT OF PUBLIC UTILS

{RONALD F. SCOTT) ( 73)

DOCKET NO. PR-020 (59FR09146)

DATE DATE OF TITLE OR DOCKETED DOCUMENT DESCRIPTION OF DOCUMENT 08/18/94 08/16/94 COMMENT OF NUCLEAR ENERGY INSTITUTE (FELIX M. KILLAR, JR.) ( 74)

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~5~1"t;J~) [7590-01-P]

NUCLEAR REGULATORY COMMISSION 10 CFR Part 20

~RIN 3150-AE90]

Disposal of Radioactive Material by Release Into Sanitary Sewer Systems; Withdrawal of Advance Notice of Proposed Rulemaking DOCKETED AGENCY: Nuclear Regulatory Commission. USNRC November 7, 2005 (11:31am))

OFFICE OF SECRETARY ACTION: Advance notice of proposed rulemaking: Withdrawal. RULEMAKINGS AND ADJUDICATIONS STAFF

SUMMARY

The Nuclear Regulatory Commission (NRC) is withdrawing an advance notice of proposed rulemaking (ANPR) that presented possible changes to the regulations governing the were proposed to account for the potential for radionuclide concentration during some types of wastewater treatment processes. NRC is withdrawing this advance notice of proposed rulemaking because it has determined that there are no widespread public health and safety concerns due to potential radiation exposures associated with the handling, beneficial use, and disposal of sewage sludge containing radioactive materials. This notice of withdrawal acknowledges public comments sent in response to the ANPR.

FOR FURTHER INFORMATION CONTACT: A. Christianne Ridge, Office of Nuclear Material Safety and Safeguards, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001, telephone (301) 415-5673, e-mail acr1@nrc.gov.

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SUPPLEMENTARY INFORMATION:

On February 25, 1994 (59 FR 9146), NRC published an ANPR to seek information to licensed nuclear facilities into sanitary sewer systems was needed. NRC was considering revising the approach to limiting these releases because of the potential effects of newly-developed sewage treatment technologies on radionuclide reconcentration during wastewater treatment. The Commission requested advice and recommendations on several proposals and asked related questions regarding whether and in what way the regulations governing the release of radionuclides from licensed nuclear facilities into sanitary sewer systems should be changed. NRC received seventy-four comment letters in response to the ANPR. The comment period expired on May 26, 1994.

Because there were concerns raised on the broader issue of long-term effects of releases of radioactive materials into sanitary sewer systems, action on the ANPR was deferred until studies were conducted regarding potential radioactive contamination in sewage sludge.

Since that time, NRC participated in the lnteragency Steering Committee of Radiation Standards (ISCORS) and co-chaired, with the Environmental Protection Agency (EPA), the Sewage Sludge Subcommittee to facilitate a systematic and thorough study of the potential concerns related to radionuclides in sewage sludge and to obtain data to support a technical basis for a regulatory decision.

Regulatory Framework Relevant to the Release of Radioactive Material into Sanitary Sewers NRC regulations governing the release of licensed material into sanitary sewer systems can be found in *1 O CFR 20.200:3. This regulation was published in the Federal Register

_ (!5§ FR 2J~6Q;},1~y 2J ,_ 1_9JH) ?_s p~rt_Qf go-9\LeJajl rnyi~i_oo. otNFiC_standar_ds tor p_ro_tection ______ .

against radiation. Licensees were required to implement this regulation by January 1, 1993. As 2

part of the 1991 revision of 10 CFR Part 20 regulations, NRC removed the broad provision that allowed the release of non-biological insoluble materials into sanitary sewers because of the potential for this material to reconcentrate in sewers, publicly owned treatment works (POTWs),

L -- -,-- -- - -- -

• and sewage s!udge. The c!..!rrer.t-!'!RC regulations req1_.1ire that any !ic~msed m3t0r!3.!. discharged--- -* -.

into a sanitary sewer system must be readily soluble in water or be readily dispersible biological material. In addition, the concentration limits for radionuclides released into a sanitary sewer system, listed in Table 3 of the Appendix B to Part 20, were reduced by a factor of 1O as part of an overall reduction in effluent release limits. In addition to the limits in 10 CFR 20.2003, NRC -

I I

recommends that licensees should maintain doses as low as is reasonably achievable* (ALARA) by setting goals for effluent concentrations_ and quantities to be only a modest fraction ( 1O to 20 percent) of their allowable limits, as described in NRC Regulatory Guide 8.37, "ALARA Levels 'for Effluents from Materials Faciliti£:!s," dated July 1993. NRC also conducts periodic inspections to ensure thatHcensees are ilJ compliance with NRC regulations.

Surveys, Studies, and Reports Relevant to the Release of Radioactive Material into Sanitary Sewers In May 1992, NRC issued the results of a scoping study in NUREG/CR-5814, "Evalua"lioh of Exposure Pathways to Man from Disposal of Radioactive Materials into Sanitary Sewer Systems," which evaluated the potential radiological doses to POTW workers and members of the public from exposure to radionuclides in sewage sludge. The first part of the analysis estimated the potential doses to workers for five cases in which radioactive materials were detected at POTWs {Tonawanda, NY; Grand Island, NY; Royersford, PA; Oak Ridge, TN; and Washington, DC). Doses from the case studies were estimated to range from less than

- 1O microsieverts per year (µSv/yr) (1 millirem per year (mrem/yr)) to 930 µSv/yr {93 mrem/yr) for

______ m_ernb_er.s_ottbe_p_ubli.c,_usioga_d_e_terministic__s_cen.ario_analysis_andJbe_rep_orted_radionuclide ___ _

concentrations and/or discharges. The second part of the study estimated the maximum 3

radiation exposures to POTW workers and others who could be affected by low levels of man-made radioactivity in wastewater. The quantities of radionuclides released into the sewer systems were assumed to be the maximum allowed under NRC regulations at the time.

Estimates of the !:iypothet!cal-, !'T!ax!ml!m-oxposurnsto-wcr!<e:-s rar.ged from :zc:-o--tc-adose roughly equal to the dose individuals receive from natural background radiation.

In May 1994, the U.S. General Accounting Office (GAO, now U.S. Government Accountability Office) issued a report, GAO/RCED-94-133, "Nuclear Regulation: Action Needed to Control Radioactive Contamination at Sewage Treatment Plants",.that described nine cases where contamination was found in sewage sludge or ash or in wastewater collection systems.

GAO concluded that the full extent of contamination nationwide was unknown. GAO also concluded that the "problem of radioactive contamination of sludge and ash in the reported cases was the resu!t, in large _part, of NRC's r_egulation, whic_h was incorrectly based on the assumption that radioactive material~ would flow through treatment systems and not

• concentrate." In June 1994, a joint U.S. House of Representatives and Senate hearing (June 2,1, 1994; S. Hrg. 103-1034) was held to officially release and address questions raised in the GAO report. At the hearing, NRG and EPA agreed to cooperate to develop guidance for POTW s and to collect more data on the concentration of radioactive materials in samples of sewage sludge and ash from POTWs nationwide.

Between 1994 and 1997, Federal, State, and industry studies were conducted to assess reconcentration of radioactive materials that are released into sanitary sewer systems. In December 1994, NRC published NUREG/CR-6289, "Reconcentration of Radioactive Material Released into Sanitary Sewers in Accordance with 10 CFR Part 20." A review of the literature

• aemonstrated that sorrie radioactive materials discharged into sanitary sewer systems

__________ reconcentrate_ io__s._e_w_age _sludge.._ 1:-IQwe_ye_r,Jbe r_ep_or:t_c_onclude.cltbatthe available_data_were. ____________ . __ _

not sufficient to assess the adequacy of the requirements in 10 CFR 20.2003 in preventing 4

~ - - - - - - - - - -

occurrences of radionuclide reconcentration in sewage sludge at levels which present significant risk to the public; nor is the available data sufficient to suggest strategies for changing the requirements.

limited survey of reconcentration of radioactivity in sewage sludge and ash samples from some of its member POTWs. Samples were obtained from 55 wastewater treatment plants in 17 States. The most significant sources of radioactivity were potassium and radium isotopes, which are Naturally Occurring Radioactive Materials (NORM). In December 1997, the Washington State Department of Health issued a report WDOH/320-013, The Presence of Radionuclides in Sewage Sludge and Their Effect on Human Health," that was based on sludge samples taken at six POTWs in the State. The report concluded that that there was no i_ndication that radioactive material in sewage sludge in the State of \Nashington poses a health risk.

The lnteragency Steering Committee on Radiation Standards (ISCORS) was formed in 1995, -to address inconsistencies, gaps, and overlaps in current radiation protection standards.

In 1996, the Sewage Sludge Subcommittee of ISCORS was formed to coordinate efforts to address the recommendations in the 1994 GAO Report. Between 1998 and 2000, the EPA and NRG (through the ISCORS) jointly conducted a voluntary survey of POTW sewagA sludge and ash to help assess the potential need for NRG and/or EPA regulatory decisions. Sludge and ash samples were analyzed from 313 POTWs, some of which had greater potential to receive releases of radionuclides from NRG and Agreement State licensees, and some of which were located in areas of the country with higher concentrations of NORM. In November 2003, the results of the survey were published in a final report, NUREG-1775, "ISCORS Assessment of

___Radjoacthlity_ inSewage_Sludge:_BadiologicaLSur:v:ey_ Besults-al'.ld-Al'.lalysis.--No widespread or- - - -- - -- - --- -

nationwide public health concern was identified by the survey and no excessive concentrations 5

of radioactivity were observed in sludge or ash. The results indicated that the majority of samples with elevated radioactivity had elevated concentrations of NORM, such as radium, and did not have elevated concentrations of radionuclides from manmade sources.

- -___ , , __ -!n-F0bruE.r-y, 2005, ths Sewage S!udge Subc0rnmitta0 pLlblished-a rop.::;rt, NUREG-1783, "ISCORS Assessment of Radioactivity in Sewage Sludge: Modeling to Assess Radiation Doses." This report contains dose modeling results for seven different sewage sludge management scenarios Jor POTW workers and members of the public. Results of the dose models and survey results indicated that there is no widespread concern to public health and safety from potential radiation exposures associated with the handling, beneficial use, and disposal of sewage sludge containing radioactive materials, including NORM.

In February, 2005, the Sewage Sludge Subcommittee also published a report, "ISCORS Assessment of R~dioactivity in Sewage Sludge: Recommendations on Management ~f Radioactive Materials in Sewage Sludge and Ash at Publicly Owned Treatment Works" (EPA 832-R-03-0028; ISCORS Technical Report 2004-04). This report provides guidance to:

(1) alert POTW operators, as well as State and Federal regulators, to the possibility that radioactive materials may concentrate in sewage sludge and incinerator ash; (2) inform POTW operators how to determine whether there are elevated levels of radioactive materials in the POTW_'s sludge or ash; and (3) assist POTW operators in identifying actions for reducing potential radiation exposure from sewage and ash.

Reasons for Withdrawing the ANPR The results of the survey and dose modeling work conducted by the ISCORS Sewage Sludge Subcommittee regarding radioactive materials in sewage sludge and ash provide a technical basis for withdrawing the ANPR. The survey demonstrated thafthe most significant -

______Je.v.eJs__otradioacfo,e_materialsJn_eOIWs_are__attributable to_NOBM.-The-dose-modeling-work- -- - - -

indicated that, in general, the doses from licensed materials in sewage sludge present a 6

sufficiently low health and safety risk to POTW workers and to the public under the current regulatory structure. Therefore, it is not necessary to modify the current restrictions regarding the release of radioactive materials into sanitary sewers (1 O CFR 20.2003) as discussed in the

.-. -- = ,_ .. , "A!'JPR; ,ln addition, pub!:c ccmmont3 indicated-that savGia: of the 0pticns clis\;usseG 0 ii*i ih.::*"* --*

ANPR would be costly to implement and may not be consistent with efforts to maintain doses ALARA. For these reasons, NRG is withdrawing the ANPR.

Public Comments on the Potential Changes to 10 CFR Part 20 In the ANPR, NRG invited comment on the following aspects of the regulation of release of radionuclides into sanitary sewers: the form of materials suitable for disposal, the limits on the total radioactivity of materials that can be released by a licensee into sanitary sewers in a year, also called the "total quantity limit," the types of limits applied, and the exemption for medical patient excr~ta. The following is a summary of those 9omments ~nd ~RC responses.

(1) Form of Material for Disposal The May 21, 1991, final rule (1 0 CFR 20.2003) allows seluble and readily dispersible

. biological material to be released but prohibits the release of any non-biological insoluble material. Because NRG recognized that new technologies for wastewater treatment, such as ion-excha.n*ge and some types of biological treatment, can reconcentrate radionuclides, NRG invited comments regarding whether and how regulations should account for the effects of different wastewater treatment technologies on radionuclide reconcentration. NRC also invited comments regarding the potential impacts that additional restrictions on the form of materials allowable for release into sanitary sewers would have on licensee operations. Public comments regarding the adequacy of the current restrictions also were received.

-Comment: Nine commenters, including representatives of the New York State Energy

____________Qtfice.,J'llew_Y:ork-8tateDepartmenLof_EnvironmentaLGonser:vation,-AMSA,-and-the Department--------- --- -

of Energy (DOE), expressed the view that the regulations should be reevaluated because of 7

new sewage treatment technologies or should account for the effects of new technologies used to treat sewage or sewage sludge. One commenter suggested that NRG limits should account for a variety of POTW-specific factors, including sludge handling processes, and sludge I

. ,. * . "** . i I

suggested NRG should take new sewage treatment technologies into account only if the results of NUREG/CR-6289, which was incomplete at the time the comment was made, indicated that new sewage treatment technologies had the potential to cause significant recoricentration of radionuclides in sewage sludge. Two commenters recommended NRG develop technology-specific reconcentration factors to help POTW operators to design appropriate pretreatment plans. A representative of DOE suggested NRG should expect that advances in the sewage treatment process would result in increasing concentration of radionuclides in sewage sludge.

Two commenters recomm~n_d~d _NRG regulation_s accq1c1n! forsy11ergistic tiealth effects of radiation and pollutants in wastewater, and one suggested NRG evaluate the synergistic effects of radiation and the chlorine and fluoride used in drinking vvater treatment.

Response: NRG acknowledges the commenters' support for regulations that would

• account for the reconcentration of radionuclides by wastewater treatment processes. However, the regulations will not be changed 'because the ANPR is being withdrawn for the reasons previously explained.

Comment: Four commenters expressed the view that NRG regulations should not take sewage treatment technologies into account. Reasons included uncertainty that new technologies will be implemented and a lack of information about the effects of the new technologies on radionuclide reconcentration. A representative of the State of Illinois Department of Nuclear Safety suggested NRG *should keep informed of technological

_ _:_ ___de~elopments,_but.sbould-110Umplementadditional restrictions-without.significant.evidence-that-- - -- - --- -- -

the current restrictions are not adequate. Two commenters suggested that, rather than revising 8

§ 20.2003 to account for new treatment technologies, NRC should consider placing additional restrictions on individual licensees to provide the necessary protection to the receiving POTWs in unusual cases where the number of licensees, size of the sewage treatment plant or nature of ths technology-* used at tha t:-eatment-plar.t-may CiJ.Li:58 dose~ a!Jove *1 CC*; .1~Gr.-,Jyr:* Orn~ -**

commenter stated that it is unnecessary for NRC regulations to account for sewage sludge treatment technologies because local POTWs have the authority and mandate to account for these technologies by developing industrial water discharge permits pursuant to 40 CFR 403.5(c)(1 ).

Response: NRC acknowledges the commenters' opposition to the proposed rule change, which supports NRC's decision to withdraw the ANPR. With respect to the comment that POTWs have the authority and mandate to impose limits on radioactive materials released inJo S§ln!tary_s~wers, NRC _nqJes that, as des()ri_b_ecJ in Sec!ion 4? of the ISCORS recommendations on management of radioactive materials in sewage sludge and ash (EPA 832-R~03-002B), POTWs may not have the same authority to regulate radioactive material as they do to regulate other materials released into sanitary sewers.

Comment: Eight commenters expressed the view that NRC regulations should account for the fact that several licensees may discharge to the same 'POTW, and, of those, five expressed the view that the regulations should also take the capacity of the POTW into account.

Five commenters stated that restrictions on the release of nonradioactive pollutants established under EPA's National Pollutant Discharge Elimination System (NPDES) account for the capacity of the receiving POTW, the wastewater treatment systems used, and the number of industrial users discharging to a POTW, and suggested any new regulations governing the release of radioactive materials into sanitary sewers should take these factors into account. A representative .otDOE expressedJhe_view..thatchanges.to_the r:egulations-to_accounUor:- - _______ - - - --- -- -

multiple dischargers should be considered but may not be necessary because sanitary systems 9

serving multiple licensees would probably be large systems in which the licensees' effluent would be diluted by many other inputs to the sewer system. One commenter suggested that, if limits on the total amount of radioactivity individual POTWs could receive were developed, any sewage into the sewer system before the limits were developed should be handled on a case-by-case basis.

Response: NRG acknowledges the commenters' support for regulations that would account for the capacity of individual POTWs and the number of licensees discharging to a single POTW. However, the proposed change will not be implemented for the reasons previously explained.

Comment: Twenty-seven commenters were opposed to additional restrictions on the fe>rms*of rtJat_erial suitable for release into ~ar'litary sewers. T\_'lf~nty-_one stated that the potential for significant reconcentration of radionuclides during wastewater treatment probably had been addressed by the May 21, 1991 changes to Part 20 {56 FR 23360) that restricted the forms of materials that could be released into sanitary sewers and lowered concentration limits. Another commenter expressed the view that it was unclear whether contamination described in the case

• studies discussed in the ANPR occurred because of violations of the existing regulatior1s, and also that it would be inappropriate for NRG to respond to individual violations of regulatory requirements by making changes to the regulations for all licensees. Representatives of six licensees indicated that additional restrictions on the forms of material appropriate for disposal would impose a significant burden on their operations. Commenters listed the costs of building new storage facilities, analyzing samples of waste to determine whether insoluble radionuclides were present, and establishing new collection, handling, and disposal procedures as well as

~ ~---r_etraining_otper.sonneLas_expensesthatwould-be-incur.redJtadditionaLrestr:ictions.were - -- - --- - -- - - --- .. - -

imposed. In addition, three commenters expressed the concern that further restricting the forms 10

of material appropriate for disposal in a sanitary sewer would not be consistent with NRC's policy that doses should be maintained ALARA.because the additional waste handling that would be required would cause doses to workers that would not be justified based on the Response: NRC acknowledges the commenters' remarks, which support the withdrawal of the ANPR. However, the NRC staff notes the need to analyze samples of waste to determine if the waste contains insoluble radionuclid~s should not impose an additional burden because the restriction on releasing insoluble, non-biological wastes was already in place when the comment was made.

Comment: Twenty-three commenters encouraged NRC to continue to allow release of readily soluble wastes that met the quantity and concentration release criteria in 10 CFR Part 20. Twenty-one of those commenters indicated that they were unaware of any significant prob_l~rns caus~d by the dispo~al of so(uble radioactive ~aterial in sewer systems. Three commenters stated that they were not aware of any mechanisms that would reconcentrate the wastes typical of biomedical research in sewage sludge, and two of these stated that the activity. **

levels were sufficiently low that reconcentration, even if it did occur, would not cause a significant dose.

Response: NRG acknowledges the commenters' support for the continuation of the

• current regulations which allow certain concentration and quantities of readily soluble radioactive material into sanitary sewers.

Comment: Two commenters suggested that NRC should change the regulation to re-

• establish disposal of dispersible non-biological materials. One commenter suggested disposal

• of nor1~bioiogicai dispersible materials should be allowed for matei"ials that have half-live~ o, less than

- 100 days- -or are below the concentrations listed in 10 CFR Part 20 Appendix C.

Response: NRC acknowledges the commenters' suggestion that release of 11

non-biological dispersible material into sanitary sewers be allowed. NRC understands that

• reconcentration of a radionuclide in sewage sludge can be limited by its half life. However, NRC has chosen not to change the regulation governing the release of radior:ictive material into Comment: Six commenters, including a representative of DOE, noted that the chemical form of materials released into the sewer can change, and that materials that are soluble When released may precipitate or sorb to solid particles in "the sewer or treatment plant. A representative of the New York State Department of Environmental Conservation suggested NRC study not only the effect of new technologies on radionuclide solubilities, but also how the solubility of radioactive materials change in sanitary sewers. A representative of DOE noted that precipitation and sorption could cause risks to individuals who work in POTWs, work in clo~e.c:9nta.9t~ith s~\1,rersLqr yv_ho incinerate or u~~ vvastewater treatment sludge, In addition,

. the commenter remarked that, while it appeared to be r~asonable to limit sewer releases t9 soluble and dispersible biological materials, NRC should realize that licensees could release insoluble or nondispersible materials to sewer systems inadvertently. One commenter e_xpressed the view that NRC regulations should account not only for the form of material when released, but the form it was likely totake after being discharged.

Three commenters expressed the view that, because the form of a material discharged is likely to change when it reaches the sewer or POTW, the modification to 10 CFR 20 that eliminated disposal for non-biological "readily-dispersible" materials may not have removed the chance that radionuclides could reconcentrate in wastewater treatment sludge. Two

• commenters remarked that reconcentration of radionuclides probably would continue, in part

. hecause POTvits" are designed to remove dissolved *contaminants from wastewater.. H~w~ve~,.

_ *- ___ ******- bo.tl:Lcommenter:ssexpressed_the-opinion thatr:econcentration is-not-necessarily. a problem-if-the- - -.- -- - - -- - *- -

dose any individual is expected to receive from exposure to sewers, sewage, or sludge is low.

12

Response: NRG understands that materials that are released into the sewer in a soluble form can precipitate or sorb to solid materials in sewers or POTWs, as discussed in NUREG/CR-6289. Most of the commenters' concerns about the potential risk to POTW workers are alidressed in ti1e ,SCORS t:Jose 1i1uddin\:rrep0ti{NUnEG'-'-"1783-), as µrev;-,Ji.isiy expia1n8d.

Although the ISCORS dose analysis (NUREG-1783) does not include an analysis of doses to workers that come into contact with sewers, those doses are expected to be limited because of the limited amount of time a worker would spend in close contact with a sewer and because of the relatively low doses predicted for most scenarios that involve contact with sewage sludge.

NRC acknowledges the concern that licensees may inadvertently dispose of insoluble non-biological material. NRG also acknowledges the suggestion that the regulations should account for changes in the form of materials that are likely to occur in sewers and POTWs and the concern about the efficacy of the 1991 revisions. For the reasons previously explained, NRC has decided not to change the regulations governing the release of radioactive material into sanitary sewers. However, NRG staff notes that, in addition to restrictions on form, NRG also has imposed annual limits in 10 CFR 20.2003 (a) (4) on the total amount of radioactivity that can be released into sanitary sewers to limit the potential for reconcentration of radioactive material in sanitary sewers, sewage sludge, and sludge ash.

Comment: Five commenters supported additional restrictions on the form of materials that can be released into sanitary sewers. One commenter expressed the view that the practice, used by some medical research laboratories, of releasing pureed tissue samples to the sanitary sewer was distasteful. Another commenter expressed the opinion that NRC should impose any requirement that would minimize the amount of radioactivity in the environment.

Responsei NRC acknowledges the commenters' support for additional restrictions on

--the-forms-of material suitable fer-release into-saRitar-y sewers but is-not-changing tl'.Je regulations--_ - - -

because it believes the current approach is sufficiently protective, as previously explained.

13

Comment: Three commenters requested clarification regarding the distinction between soluble and readily dispersible materials. One requested that an information notice be produced to address materials used in the biotech industry.* Another commenter expressed the

, --.. , concom thnt-it *.-:ou!d*-be difficult to-demonst;-ate ccmp:lance w;t:-; tll.3 i&atiiction tha.t*0nly :solubie -,

• and readily-dispersible biological materials be released into sanitary sewers if colloids that flow through filters and resins are classified as non-biological dispersible material. The commenter proposed an operational procedure to distinguish between soluble and readily dispersible materials. A representative of the New York State Department of Environmental Conservation noted that traces of insoluble radioactive material could be released into sewers with soluble materials, and requested that NRC establish a lower limit of detection for insoluble material.

Response: NRC acknowledges the commenters' request for additional guidance.on how

/

license_es ~houl_d d~monstrate the sohJbjlity of radioactive_material released ):o sanitary sewers, Although NRC does not have plans to provide additional guidance on this issue, the staff notes that, as discussed in NRC Information Notice 94-007, licensees are free to develop alternative methods of demonstrating the solubility of materials they wish to release into sanitary sewers and to subniit these procedures to NRC for evaluation on a case-by-case basis.

(2) Total Quantity of Material In the May 21, 1991 final rule, NRC did not change the total quantity limits, which allow a licensee to release 185 gigabecquerel (GBq) (5 curies (Ci)) of H-3, 37 GBq (1 Ci) of C-14, and 37 GBq (1 Ci) of all other radioactive materials combined into sanitary sewers each year. The use of total quantity limits has been a long-standing requirement and was originally included in the rule (1 O CFR 20.2003(a)(4)) to address concerns regarding the possibility for

. reconcentraticin of radionuclides. In the ANPR, .NRC fnvited comments about the alternative

.. approach.otlimiting.the.annuaLrelease.of each.radionuclide-individually.. NRG-also invited- - - . - - - --- -- - -

comments about the current total quantity limits and the potential impacts that additional 14

restrictions on the annual releases into sanitary sewers would have on licensees.

Prior to publishing the ANPR, NRG received a petition for rulemaking to amend 10 CFR 20.303 (superseded by§ 20.2003) and § 20.305 (superseded by§ 20.2004) from the published in the Federal Register (58 FR 54071; October 20, 1993). The petitioner requested that NRG amend its regulations to require that all licensees provide at least 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> advance notice to th.e appropriate POTW before releasing radioactive material to the sanitary sewer system. The petitioner also requested that NRG exempt materials that enter the sanitary waste stream from the requirements regarding Commission approval for incineration under NRC's current regulations. NRG solicited comments on the petition in the ANPR. The denial of the petition was noticed in the Federal Register on January 27, 2005 (70 FR 3898).

Comm~nt: ~ix (?Omment~ receive~ in respons~ to t~e)\NPR supported_an11w~.I _to.tal quantity limits. Two commenters, including a representative of DOE, suggested total quantity limits should be retained because they help prevent reconcentration of radionuclides in sewage sludge and two suppor:ted the total quantity limits because they are easy for licensees arid regulators to understand and implement. Two commenters, including the representative of DOE, suggeeted it may be worthwhile for NRG to evaluate whether the regulation could be optimized by changing the annual release limits for some radionuclides. A representative of the Illinois Department of Nuclear Safety expressed the opinion that the relatively low doses calculated for the case studies described in the ANPR and predicted for other scenarios in NUREG/CR-5814 indicated that reconcentration of radionuclides in sewage sludge could be addressed on a case-by-case basis rather than by changing the total quantity limits in § 20.2003.

________ . ___ Response:_NHG_ack owledges_supp_ort for Jhe current approach of .using.annual limits _________ *-- _

on the total quantity of radioactive material that can be released into sanitary sewers by a 15

licensee. In accor~ with the commenters' suggestion, NRG performed a study to evaluate the reconcentration of various radiounuclides in POTWs, the results of which are discussed in NUREG/CR~6289 .

.-*., Cor..;r,ent:-c-*Arepisseiitat:va of ths City-cf Oa:. n.idge madc*positiveand ney&tivEr statements about NRG annual total quantity limits. The commenter stated that both concentration and total quantity limits were necessary to ensure protection of workers and to ensure that traditional methods of sludge disposal remain acceptable. However, the commenter also expressed the view that the current values of the total quantity limits are too high and stated that disposal of 37 GBq (1 Ci) of Co-60 annually to the Oak Ridge POTW would result in unacceptably high concentrations of Co-60 in the POTW's sludge, especially if the material was released during a relatively short time period. The commenter also expressed the opinion that the total qua_ntity li_mits are _in_appropriate _for low spe_cific actbiity raq_ionuclides becau_se _of the _

__- large mass of the radionuclide that could be discharged. As an example, the commenter stated that release of 37 GBq (1 Ci) of U-238 to the city's POTW in a year would result in a mass concentration of uranium of more than 0.05 percent in the POTW's sludge, making the sludge licensable source material. In addition to these comments, the commenter suggested that, because the mean retention time of sludge at a POTW typically is one month or less, a monthly discharge limit would be more appropriate than an annual limit.

Response: NRG acknowledges the commenter's concern about the release of Co-60 to a POTW and the suggestion that quantity limits should be implemented on a monthly, rather than an annual, basis. The staff notes that the 1991 revision to 10 CFR Part 20 that eliminated the discharge of insoluble non-dispersible radioactive material into sanitary sewers was implemented to reduce the possibility of significant contamination- of sewage sludge with

___________ insoluble radionuclides,-sucb-as Co,,.60.-NRC-has-decided-not to change the regulations- - - - - - - - -- - - - -

governing sewer release of radioactive material for the reasons previously explained. NRG 16

acknowledges the commenter' concern about the applicability of the total quantity limit to low specific activity radionuclides. However, NRC does not agree that the accumulation of large masses of low-specific activity radionuclides in POTWs is likely to be problematic. In addition when the purpose of the limits is not radiation protection, as discussed in Section 4.7 of the ISCORS recommendations on management of radioactive materials in sewage sludge and ash (EPA 832-R-03-0028).

Comment: Twenty-three commenters described concerns about the .current approach of limiting the total amount of radioactivity a licensee may release into a sanitary sewer system.

Nineteen commenters expressed the opinion that it is not appropriate to apply the same total quantity limit to large and small facilities that discharge different amounts of sewage and

.therefore dilute radioactive materials to different extents. Another commenter stated that NRC shoule! not attempt to impose total quantity limits on large facilities. Seventeen commenters expressed thevievy that NRC should consider relaxing the total quantity limits because of the new restriction on 1he form of material and lower release concentration limits implemented .in the 1991 revision to 10 CFR Part 20. The commenters expressed the opinion that adherence to the new form and concentration limits may eliminate the need for tctal quantity limits. Three commenters suggested that, instead of limiting the total quantity otradjoactivity a licensee could dispose of into a sewer, NRC should focus on the radionuclides and chemical forms of radionuclides that reconcentrate in POTWs to a significant extent. One commenter expressed the concern that a person could dispose of 37 GBq (1 Ci) of Cs-137 within a month while remaining in compliance with the current concentration and total quantity limits. Another commenter suggested concentration iimits are sufficient and are superior "to total quantity iimits

- - --because concentration limits account for the total volume of water a licensee releases to the sanitary sewer system. The commenter noted that, although the nominal purpose of the total 17

quantity limits is to eliminate reconcentration, the total quantity limits do not appear to prevent reconcentration, as evidenced by the case studies described in the ANPR. The commenter suggested reconcentration could be avoided by reducing the allowable concentrations of those radiorn.:didos that h~ve* shown *a tondancy to ;econcer.!;-ato* in sewage* s1udga. - -*

Response: NRG acknowledges the comment about the application of the same total quantity limit to large and small facilities, but believes that the system is appropriate. Because the total quantity limit is designed to reduce the potential for reconcentration of radionuclides at POTWs, an appropriate total quantity limit is more dependent on the volume of sewage received by a POTW than it is on the volume of a licensee's effluent.

NRG acknowledges the comment that total quantity limits should be relaxed or eliminated, but does not agree that the limits on form and concentration eliminate the need for annual quantity ljmits.__ A12, _di'2,CU_S'2,e~ in N_UREG/9R~6289, the form of radionuclides can change upon entering a sewer or POTW because.of sorption and precipitation. NRG also acknowledges the concern that total quantity limits did not prevent the cases of contamination

• discussed in the ANPR. NRG believes that limiting both the form and total quantity of material released into sanitary sewers is the best way to limit the potential for significant reconcentration of radionuclides released by licensees into sanitary sewers.

NRG acknowledges the commenters' suggestion that, instead of imposing total quantity limits, it should focus on those radionuclides that have been shown to reconcentrate in sewers or sewage sludge. NRG also acknowledges the commenter's concern about the discharge of Cs-137 but believes the current approach to be sufficiently protective for the reasons previously explained.

.. Comment: One commenter expressed ttie view that additional limitations on-the release

_ .of 1:1-3 and.C-j 4_into_sanitary.sewers would not.pr:oduce any. public.health benefit-because any- -- - - -- - - -- - - ..

dose an individual received from sewer-disposed H-3 and C-14 would be negligible in 18

comparison to the dose the individual would receive from naturally-produced H-3 and C-14.

Response: NRG acknowledges the commenter's view that additional restrictions on the quantities of H-3 and C-14 are unnecessary. The comment supports the withdrawal of the H-3 and 37 GBq (1 Ci) of C-14 in addition to the release of 37 GBq (1 Ci) of all other radionuclides combined.

Comment: Eight licensees expressed the view that additional restrictions on the total quantity of radioactive material that could be released into sanitary sewers annually would have a severe negative impact on their facilities' operations. Representatives of a biomedical company, a university, and the National Institutes of Health (NIH) noted that a reduction in the total quantity limits would impose a significant financial burden on organizations involved in

_biotechnjcal research,_deveh;,pment, or medical practice, especially if the limits wer_e reduced to a point that liquid wastes would need to be solidified and disposed of as low level waste (LLW) ..

The representative of NIH estimated that solidification and disposal of liquid wastes as LLW wo61d cost NIH 2.8 million dollars annually, as of 1994. Two commenters remarked that companies would bear the additional expense of acquiring or building storage facilities or -

acquiring treatment technologies to remove radioactivity from liquid waste streams. One commenter noted that LLW disposal of many of the materials currently released into sanitary sewer systems would be a particularly unnecessary expense and inefficient use of LLW landfill space because, in many cases, the material would decay to negligible quantities before it reached the LLW landfill.

Five commenters associated with medical research facilities or companies that produce radiciphafrnaceuticals suggested additional restrictions on the total quantity of radioactive

____ materiaLtbat_could be-released-into-sanitary_sewers-annually-could-harmpublic l"lealth and-- -

safety by causing companies to limit biomedical research and development efforts. One of 19

these commenters stated that the amount of radioactivity released into sanitary sewers in association with medical research was insignificant as compared to the amount of radioactivity released to sewers in patient excreta and concluded that release of radioactive materials excreta is continued. Two commenters expressed the opinion that additional restrictions on _the total quantity of radioactivity a licensee could release into sanitary sewers annually would not be consistent with efforts to maintain doses ALARA because* workers would be exposed to radioactive material while processing liquid waste to make it suitable for LLW disposal.

A representative of a company that offers health physics services stated that, for most of its clients who want to release radioactive material into sanitary sewers, the most limiting factor is the annual total quantity limits. A representative of the University of California expressed concern th?t th~ nul'!leri9al limits in 1_0 CFR 20.2003 ~ould be _l,ow_e~eg,_ altl:,9ugh_ the tJniver~ity

_typically releases only 11.1 Gbq (0.2 Ci) of radioactivity into sanitary sewers each year.

Response: NRG acknowledges the commenter's concerns about the potential impacts of .additional restrictions on the total quantity of radioactive material that a licensee can release to sewers annually. As previously explained, the additional restrictions discussed in the ANPR

• will not be implemented.

Comment: A representative of AMSA stated that. although the organization understands that lowering* total quantity limits could impose financial burdens on licensees, additional restrictions are appropriate if they are needed to prevent contamination of sewage sludge.

Response: NRG acknowledges the commenter's statement, but has decided not to change the total quantity limits because it believes the current approach is sufficiently protective

• tor the reasons p*reviously explained.

_ _ . ____ .Comment: Twenty-one.letters.received.in response .to-the ANPH included-comments on - -

the Northeast Ohio Regional Sewer District's request for NRG to amend its regulations to 20

require that all licensees provide at least 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> advance notice to the appropriate POTW before releasing radioactive material into a sanitary sewer system. Six of the twenty-one commenters supported a requirement for licensees to provide the sewage treatment plant with These commenters supported a wide range of reporting requirements, including the petitioner's request for a 24-hour advance notification before licensees release radioactive material, monthly or annual discharge reports, reports-of releases that could be-a threat to the POTW workers or the environment, or notification of large accidental releases. One commenter suggested licensees should analyze effluent samples and include the results in discharge reports. A representative of AMSA stated that advance notice of releases is necessary so that POTW operators can ensure worker health and safety and make appropriate decisions about

_s_ludge disposal and reuse.

Fifteen of the twenty-one commenters did not support_such a requirement for licensees to provide at least 24-hour advance notice to the appropriate sewage treatment plant before releasing radioactive material into a sanitary sewer system. Several commenters. said that a 24-hour advance notification would result in an unnecessary regulatory burden without providing additional protection against radiation or dose reduction. These commenters expressed the view that the existing regulatLons for discharges of licensed material-maintain doses at or below

• the existing dose limits for members of the public and if licensees meet the ALARA goals, the 24-hour advance notification would be unnecessary. Several commenters noted that such notification would be impractical because most releases are continuous and involve very small quantities of radioactive material. For example, discharges from hospitals and medical facilities

. would change dailidepending on the number-of patients treated and types 6t treatment used .

. SeveraLcommenters also_noted _thaUhere _could be- large cost implications and-regulatory burdens associated with such notification. In addition, commenters were concerned 21

that data about releases of radioactive material could be misinterpreted if release reports were received and interpreted by sewage treatment plant personnel rather than radiation safety specialists. Several commenters stated that such an NRG requirement for licensees to provide

• • ..c:.. *-~*-'

over their local sewer district, already have requirements to follow the Clean Water Act, and may establish a pretreatment program for wastewater acceptance. One commenter noted that the usefulness of a 24-hour advance notification should be assessed after the new limits for sewer discharges are in place.

Response: NRG has determined that a requirement for advance notification of each release of radioactive material to a sanitary sewer would impose an unnecessary regulatory burden on licensees without a commensurate health and safety benefit. Additional reasons for

_t~e__denial_ qt the petition are c;iiscl!~S!;!tj in tbe_ Fed_era/ _R_egist(}]r noti_ce_ p_uQli_~heq or, J~nuary 27, 2005 *1(70 FR 3898).

Comment: Six comment letters received in response to the ANPR included comments on the-Northeast Ohio Regional Sewer District's request that NRG exempt materials that enter the sanitary waste stream from the requirement for NRC approval prior to treatment or disposal of licensed material by incineration. Four commenters supported such an amendment because, given the radioisotopes and activities involved, the pathways for human exposure from radioactive wastes seem no more or less significant if the wastes are dispersed into water or air.

These commenters suggested that, if release into a sanitary sewer system is to be considered disposal, the limits should be set so that no turther regulation of.the radioactive material is needed after release. One commenter did not support such an amendment and expressed the view that it wou.ld only serve to provide an open-e.nded system for radioactive material to pass

__ into the-environment and to-the-public-without-limitation- or-characterization. - -- - - - - - - --

Response: NRG approval to incinerating waste is required to ensure that NRG may 22

evaluate the potential impact to the public health and safety and the environment on a case-by-

- case and site-specific basis. Hazards associated with incineration of sewage sludge will depend on the specific characteristic of the sludge and the radionuclides that may be present published on January 27, 2005 (70 FR 3898}.

(3) Type of Limits The present-approach to limiting releases of radioactive material into sanitary sewers is to specify limits on both the monthly average concentration of each radionuclide in a licensee's sewage and the total quantity of radioactive matter that a licensee can release annually.

Table 3, Appendix. B, of 10 CFR Part 20 lists the allowable monthly average concentration of each radionuclide in a licensee's release to sewers, Allowable concentrations are based upon a

~alcu~a!ed dose of 5 Q1$v/yr (~00_ l'T)r~f!l/yr) _d!,Je_ to i11gestion _C>f 2 _liters pE:lr Qf!Y of_ a lic~ns~e'l:i __

effluent into the sanitary sewer.

In the ANPR; NRG invited comments on this regulatory approach. Specifically, NRG invited*comment as to whether it should continue to base concentration limits on the assumption that an individual would drink 2 liters of the effluent from a licensee's facility each day, and':

whether exposure at other locations, such as at a POTW, should be considered in developing release limits. In addition, NRG invited comments about how other exposure scenarios, such as exposure to radionuclides in contaminated sludge, should be accounted for. NRG also invited comments as to whether it should establish limits in terms of dose instead of limits on the quantity and concentrations of radioactive material discharged. Included with the responses to these inquiries were several comments about monitoring, enforcement actions, and regulatory authority to set limits ori releases of radioactive material fnto sanitary sewers that have been i.

____ addressed_with-the-GeneraLComments .. - - - - - - - - -- - - - -- - - - - - --- - - - - - - - - -- -- --

Comment: Twenty-three commenters supported the current modeling approach of 23

assuming that an individual ingests 2 liters of water taken from the Hcensee's outfall to the sewer system each day. Nineteen of these commenters, representing hospitals, biomedical laboratories, and universities, noted that this assumption is conservative and easy for licensees has been "largely successful as a regulatory measure". The commenter also expressed the view that, because this type of consumption is not expected to be chronic, it is appropriate to base concentration limits on a calculated annual dose ofS00 mrem instead of 100 mrem. One commenter did not specifically address the assumption that an individual would drink 2 liters of a licensee's discharge each day, but did support the use of a licensee's sewer outfall as an appropriate exposure location. Two commenters expressed the view that the modeling assumption was appropriate because individuals, including children, could drink or otherwise be

~~J:)()9eq to yi,_13:~er ~ir~ctly d~wn~trea_m _of__ a_~~w~r_Ol:!_tfall. __ Another ~9m_1T1enter tbat suppo_rted the current assumption expressed the view that modeling exposure at a licensee's outfall to a sewer system is consistent with modeling exposure at a licensee's fence line, as is done in other NRG assessments, and that considering a downstream location would be inconsistent with modeling exposure to the maximally exposed individual.

Response: NRG acknowledges support for the current modeling assumption. The staff ,

notes that several commenters appeared to believe that the concentration. limits were based on the assumption that an individual would consume 2 liters of sewage from a POTW outfall, rather than 2 liters of a licensee's effluent into the sewer system, each day. Staff notes that the assumption that an individual would consume a licensee's effluent is more conservative than the assumption that an individual would ~onsume POTW effluent because the concentration of radionuclides in POTW effluent will have been diluted with effluent from all of the other

_ _ _ ____ residential a dJ dustrialdischargers lo_the POTW. _ _ _ __ _

Comment: Three commenters expressed concern that the concentration limits are 24

based on an annual dose of 5 mSv (500 mrem) and stated that the concentration limits should be based on an annual dose of no more than 1 mSv (100 mrem), in accord with the 10 GFR 20.1301 limit on doses to members of the general public from licensed activities. One

,-,* commenter--sxpresscd-the,view thaMhe *1 mSv- {1-C0*mrem) ailnuai**pubiitdbst; m*i ,it'i:iiiotild-be * --

lowered. Two commenters expressed the view that the dose from ingesting a licensee's effluent should be included in the 1 mSv (100 mrem) TEDE annual public_ dose limit rather than

• being calculated separately and excluded from the 10 GFR 20.1301 limit. Another expressed the view that, if any activity were to be permitted to be discharged into sanitary sewers, the limiting dose for exposure to sewage sludge should be no greater than the dose limit for low level radioactive waste.

Response: NRG acknowledges the commenters' concern about the hypothetical dose

_u~ed _as thE3 _~a~is_ for the concentration li111its. Af3 giscu_Ei~eq in tbe__ ANPR, the NRG staff

. believes the concentration limits based on an annual dose of 5 mSv (500 mrem) are reasonable because it is unlikely that an individual would have access to and would consume water at the point at which a licensee discharges water into the sanitary sewer and because dilution from additional discharges into the sewer is likely to reduce the expected dose to well below the 1 mSv (100 mrem) annual dose limit.

NRG also acknowledqes the commenters' suggestion that the dose from consuming effluent released into the sanitary sewer be included in the TEDE from other licensee operations. However, in the case of sewer discharge, the point of exposure is expected to be remote from the licensee's facility. Because individuals that could be exposed to a facility's effluent are different individuals than those that live closest to the facility, it would be unrealistic to include the dose from exposure to a licensed facility's effluent in the total dose from all of the

. facility's activities. The staff notes-that-comments-regarding .the-appropriate-value-of the annual-dose limit for members of the public from licensed activities specified in 1O GFR 20.1301 are 25

beyond the scope of this rulemaking.

Comment: Ten commenters did not support the use of the current modeling approach of assuming that an individual ingests 2 liters of water taken from a licensee's sewer outfall each ds.y_ ./\!most all-of these commentar3"expressed thevievv th.iHhcr ci;:;s0mption is tmrnailsifo: -

One commenter expressed the view that, while the assumption that an individual ingests 2 liters of water taken from a licensee's sewer outfall each day is a reasonably conservative basis for concentration limits, the assumption may not be a-basis for total quantity limits because it would over-emphasize the potential impact of short-lived radionuclides.

Response: NRG acknowledges the commenters' opposition to the current modeling approach. However, it will be retained because the ANPR is being withdrawn for the reasons previously explained. With respect to the comment about the basis for total quantity limits, the

_stafJ\n~tes that t~e assumption th~t _an individual i,yould_ c_onsume a licen~~E3's effl!Jent is LJsed a,s _

the basis of the concentration limits but is not used as the basis of the total quantity limits.

Comment: Ten commenters suggested alternate locations that NRG should consider when developing restrictions on the release radioactive materials into sanitary sewer systems.

Of these, five suggested NRG consider the dose to a person ingesting water once it has reached or is leaving a POTW rather than at the licensee's sewer outfall. Three commenters suggested NRG consider locations downstream of a PQTW that would be likely to be locations from which a municipality would extract drinking water, while one suggested doses in the nearest residential area should be considered. Another commenter suggested realistic models would incorporate a factor of at least one million between the point of discharge and a receptor locations, and suggested that, if NRG used a more realistic dose model, it would become clear that additional release restrictions are unnecessary. One commenter suggested that, in considering. potential .doses -to members of the public, NBC. should consider. that.sludge could -

be sent to a landfill, applied to agricultural land, or made into compost for sale to the public.

26

Five commenters, including representatives of POTWs and DOE, recommended NRG consider doses to sanitation workers and two commenters suggested NRG consider doses to workers that come into contact with sewage collection systems as well as POTW workers. One suggested external radiation by gamma emitters may be an important pathway for POTW workers, whereas ingestion of beta emitters would be expected to be more important at a downstream drinking water source. Five commenters suggested NRG consider that the careful treatment given to sewage and sludge because of the other hazards it presents should limit doses to sanitary system workers. One commenter added that NRG regulations also should prevent contamination of sewers, POTWs, receiving waters, and sludge and ash disposal sites.

Another commenter suggested NRG consider potential exposures to all POTW residuals,*

ir:iclutjing sludg_l?,_scre9.nings, grit,_and ash. T_he q_omr:nenter §l_so pointed ouphat~evver pipes may leak and suggested NRG consider the potential for groundwater contamination.

Response: The alternate locations that the commenters suggested should be considered in dose models will not be used as a basis for a revision to the regulations because the ANPR is being withdrawn for the reasons previously explained. However, the NRG staff notes that several of the modeling scenarios suggested by the commenters, including sludge han_dling by POTW workers, sludge incineration, and exposure to land-applied sewage sludge, were considered in the ISCORS dose modeling project (NUREG-1783).

Comment: Six commenters, including representatives of POTWs and the New York State Department of Environmental Conservation, suggested that, in addition to protecting the general public and sanitation workers, NRG regulations should ensure that POTWs can continue to use traditional forms of use or disposal of biosolids (sewage sludge). One

_commenter-noted .that events that have.notresulted in .significant worker exposure have prevented POTWs from using or disposing of sewage sludge.

27

Response: Additional restrictions on the release of radioactive material into sanitary sewers will not be implemented for the reasons previously discussed. Section 7.2 of the ISCORS recommendations on management of radioactive materials in sewage sludge and ash (EP,l\.832-R-:03**0028} provides-gi..iidarn~e to* iissiat POT\-\' opsrat0i3*ii'i *reducing soiff0es c,*f **

radiation entering their treatment facilities.

Comment: Four commenters made suggestions about ways to account for complex exposure scenarios, such as exposure to contaminated sewage sludge.* One commenter suggested that a variety of scenarios should be evaluated and that the scenario resulting in the highest dose should be used to establish limits on releases of radionuclides to sewers. Another commenter expressed the opinion that dose mod.els should reflect limitations on access that are imposed to protect individuals from other health risks associated with sewage and sewage sluq_g_e. One co_mmenter sugge~t~d _no model 9qL1ld ?deguat~ly represent c_or:r1plex expos_ure _

sce,narios because dose modeling was not sufficiently well developed.

Response: The approaches the commenters s_uggested will not be used as a basis for new restrictions on the release of radioactive material into sanitary sewers because the ANPR is being withdrawn for the reasons previously explained. NRG staff acknowledge the commenter's statement about the capabilities of dose modeling.

Comment: Of the fourteen commenters that addressed dose limits, seven supported implementation of dose limits. One commenter expressed the view that dose limits are preferable to limits on concentration and quantity alone because dose limits are easier to relate to risk. The commenter suggested the assumptions used to evaluate compliance with dose limits should be realistic. The commenter also suggested the use of a tiered approach, in whicti simple bounding assumptions are first used to evaluate compliance, and more complex models

.and more.site-specific data.are used only iUhe simple.bounding model does not-demonstrate - --

compliance. Another commenter suggested that, if the appropriate models were developed, 28

releases into sanitary sewers should be controlled under the requirements of 10 CFR 20.1302 and ALARA guidelines just as other facility effluents are. The commenter also noted that the potential doses calculated in NUREG/CR-5814 indicate that the current regulations governing on facility effluents. Two commenters expressed the view that dose limits should be adopted only if the current limits were found not to be protective of the public or POTW workers. Four commenters agreed with the proposal-in the ANPR that; if dose limits were adopted,-NRC should publish a regulatory guide that included concentration and total quantity guidelines to facilitate compliance. One commenter asked if licensees would have a choice of complying with the dose limit or with the concentration and quantity guidelines published in a Regulatory Guide.

Two commenters advocated dose limits, but expressed the view that the dose limits should be

_ base~_ O!") _mea_s!:-'_r~d ~a_d!o_nuclid~ c~mc_entr~tions from sal}lple~ tak_en from_ sewer_ outfalls and intakes or on readings from dosimeters placed at POTWs rather than on concentrations calculated based on assumptions about releases to and dilution in sanitary sewers.

Response: NRG acknowledges the commenters' support for sewer release restrictions to be expressed as limits on dose rather than activity. NRG also acknowledges the commenters' suggestion that compliance with dose limits be madet,ased on sample measurements. _However, these options will not be implemented because the ANPR is bP-ing withdrawn for the reasons previously explained. No response is required to the commenter's question about compliance with dose limits because the ANPR is being withdrawn.

Comment: Of the fourteen commenters that addressed dose limits, six commenters opposed dose limits, and a representative of the New York State Department of Environmental Conservation noted potential problems with implementing dose limits but suggested NRG study the option. Almost all of the commenters that opposed dose limits commented on -the -

uncertainty of assumptions about exposure pathways and the relative complexity of 29

. . implementing dose limits as compared to concentration *and quantity limits. Three commenters predicted dose limits would require more regulatory oversight because NRC would need to review each licensee's dose model. One commenter expressed the concern that dose limits material into sanitary sewers. One commenter supported the current limits but suggested that, if dose limits were adopted, the dose limit should be 500 mrem/yr, realistic modeling

• • assumptions sh-oold b-e made, and the modeling assumptions-to be-used ih-com-pliarice calculations should be clearly defined. Another commenter advocated the use of limits expressed in "verifiable units of measure" rather than limits expressed as dose and expressed doubts about the capabilities of computer models used to calculate dose. Another commenter stated NRC should not limit the dose a patient could receive from a prescribed medical Rr_oc;~_cj1Jr_e~_

Response: NRC acknowledges the commenters' opposition to dose limits, which will not be-implemented because the ANPR is being withdrawn.

With respect to the commenter's concern that NRC should not limit the dose a patient could receive due to a medical procedure prescribed by his physician, the NRC staff notes the scope of the ANPR was limited to potential doses due to exposure to radioactive material ln sewage o_r sludge. In general, NRC regulates the uses of radionuclides in medicine as necessary to provide for the radiation safety of workers and the general public and does not intrude into medical judgments affecting patients. Additional detail on this topic can be found in NRC's Final Policy Statement on the Medical Use of Byproduct Material, which was published in the Federal Register on August 3, 2000 (70 FR 3898).

Comment: Two commenters expressed concern that NRG would consider setting any non-zero dose .limit.for-R.OTW workers. Both commenters expressed-the-view that any dose -

received by a POTW worker because of exposure to radionuclides released into sanitary 30

sewers by licensees would not be ALARA if the only reason such releases were allowed was to provide an inexpensive method of waste disposal to NRG licensees.

Response: NRG acknowledges the commenters' concern about sanitary system worker

.., _.- .... -doses.but dieagrees with t!13vb*w,:tr.ato:1ly-a-dose'Of-zem could be,AlARA. Tlie staff notes*

0 that the ISCORS dose modeling report (NUREG-1783) concludes that POTW worker doses typically are very low and are dominated by exposure to NORM. Additional restrictions on the

- - - - -release of radioactive material *into sanitary sewers will not be-implemented for the reasons previously discussed.

Comment: Three commenters expressed views on the appropriate time period over which releases should be averaged. A representative ofa municipality suggested monthly averages should not be used because the practice encourages the use of dilution as a means . i

__ of_:meeti!1~ the r~g~l~tions: A rei:?_r~se.n!a!iv~_ of AM_~.A. sugg§lsted daily aver_ag~s should be used because POTW workers could be exposed to sewage and sludge on a daily basis. In contrast, a representative of a public utility district supported the use of weekly or mo thly averages.

Response: NRG acknowledges the commenters' suggestions about appropriate time periods over which releases should be averaged. NRG believes monthly averages are appropriate because the effects of small quantities of radioactivity released during a month are not expected to depend on the time period over which the radioactive material is discharged.

Monthly limits will be retained because the ANPR is being withdrawn for the reasons previously explained.

Comment: Ten commenters supported the development of annual release limits for individual radionuclides or groups of radionuclides. Eight commenters suggested limits for

.individual radionuclides.should_be_based.on the results of.dose.models .. Specific factors that commenters suggested should be included in a dose model included a radionuclide's specific 31

activity, half-life, and solubility, and factors affecting the radionuclide's fate and transport in sewers, wastewater treatment process, and the environment. Two commenters recommended NRC consider imposing different discharge limits for those radionuclides and chemical forms

. . . . ,. -** -- thatreconcentrf;l.!e in- !?.OT.Ws.to a_significan:textent .a.ndJl::!ose Jhat do_nQt. Another cornlT)eJJter .__

suggested NRC set limits for individual radionuclides based on whether they pose a risk primarily due to internal or external exposure and specifically suggested pathway modeling

- - should include-expesure to radionuclides-that-volatilize from sewage ata POTW, exposure to-raw river water, and ingestion of treated river water. Another commenter suggested NRC consider the fate of radionuclides in engineered wetlands that are used by some POTWs as a final treatment step. One commenter predicted annual release limits for individual radionuclides would provide more flexibility to licensees and eliminate the need for special licensing exceptions to the current total quantity limits. A representative of DOE predicted t_hat only a very few radionuclides would require reduced quantity limits even if the limits were conservative to bot.ind variations in sewage plant designs and operating characteristics and to account for potential improvements in waste water treatment technology.

Four commenters suggested that annual release limits should be based on radionuclide half-life. A representative of the Texas OE.ipartment of Health predicted it may be difficult for licens~es to keep track of the quantity of eaq_h radionuclide relea~ed and suggested NRC

• impose one quantity limit for short-lived radionuclides that would be unlikely to reconcentrate in sewage sludge and a lower limit for long-lived radionuclides that have a greater potential to reconcentrate in sewage sludge.

A representative of the New York State Department of Environmental Conservation noted that it may not be appropriate to use Annual Limit of Intake (AU) values as a basis for annual retea~e lirn_it~ for inqivjd_u~l_ratjio_nu9li9EJs, a_s suggested_in t_!,e ANPR, b~ca!Jse th'? _

ingestion pathway may not be the most significant exposure pathway and because the qhemical 32

form of a radionuclide may be significantly different when.it is released from a POTW than it was when it was originally discharged to the sewer. One commenter suggested both the total quantity of all radionuclides as well as quantities of individual radionuclides released should be limited, and that quantity limits for indivirl11al radir:muc!iries sh0u!d be h::!sec! or fre.ctioris, rether than multiples, of ALI values. The commenter also suggested annual limits should assure the lowest possible rather than the lowest "reasonably achievable" exposure of members of the public to radionuclides.

Response: NRG acknowledges the commenters' support for the development of annual release limits for individual radionuclides or groups of radiounuclides. However, the proposed change will not be made because the ANPR is being withdrawn for the reasons previously explained.

Comment: Five commenters opposed the development of annual release limits for individual radionuclides. Two commenters suggested the low calculated doses received in the case studies discussed in the ANPR indicate the current regulations are adequate. Two commenters suggested that, if NRG were to change the annual quantity limits, it should focus on Co-60, Sr-90, Gs-137, lr-192, and Am-241, because these radionuclides were identified in NUREG/CR-5814 as having the potential to result in a significant dose, bused on the pre-1991 release limits. A representative of the State of Illinois Department of Nuclear Safety recommended NRG change the total quantity limits only if the releases of Co-60, Sr-90, Cs-137, lr-192, and Am-241 that were determined to be potentially problematic in NUREG/CR-5814 would still be permitted, given the restrictions on form and lower concentration limits introduced in the 1991 revision to 1O GFR 20.

Another commenter noted that, although limiting the quantities ot radionuciides released would not necessarily be difficult, the need to analyze batches of vya~tew~.ter to determine the quantities of individual radionuclides being released would be a significant burden as compared 33

to the current method the company uses, which is to base releases on DOT shipping papers that identify the most limiting radionuclide in a batch. However, the commenter also noted that using limits based on multiples of ALI would be "on the right track" and would be similar to methods usedin Europe.

One commenter expressed the view that the biokinetics of individual radionuclides could not be modeled well enough to provide a basis for limits on the quantity, concentration, or form in which a radionuclide could be discharged, especially because the models would not include the synergistic effects of radiation and other pollutants. The commenter also expressed the view that the exempt quantities published in 10 CFR Part 30 represented quantities "below regulatory concern" (BRC) and suggested it would be inappropriate to use multiples of the exempt quantity values as annual quantity limits.

Response: NRC acknowledges the commenters' opposition to annual release limits for individual radionuclides, which supports withdrawal of the ANPR.

(4) Exemption of Patient Excreta The fourth topic on which NRC invited comment was the exemption of patient excreta from the regulations governing releases of radioactive material into sanitary sewers. NRC

• received fifty-two letters that addressed the exemption for patient excreta.

Comment: Forty-four commenters, including a representative of AMSA, recommended the exemption for patient excreta be continued and suggested it required no additional evaluation. Thirty-three of the commenters stated the exemption is necessary to maintain doses ALARA. Several commenters predicted that the radiological risks to health care workers, in the case of hospitalized patients, or family members, in the case of patients released from the

~ hospital, associated with managing excreta would be far greater than any risk that the excreta

__ would pos~ to POTW workers or _members of th_e general pu_blic on_ce re~ea~ed !o !he l:3ew_er _

system. Several commenters noted the possibility that excreta could be spilled or inadequately 34

shielded, especially in the case of patients that had been released from the hospital. One commenter expressed concern about radioactive materials volatilizing from containers of urine.

Another commenter noted that children or pregnant women could be subject to increased risk from excreta stored in the home if the i:>.YArnption. "'*'ere withdrawn. Seven commenters noted that, in addition to the radiological risks, collection and storage of patient excreta also could pose biological hazards.

Twenty-seven of the commenters that supported the exemption noted the short half life of most radiopharmaceuticals, and most of these commenters hypothesized that the risk that*

radiopharmaceuticals could pose to sanitary system workers or members of the general public would be limited by their short half lives. Representatives of two hospitals indicated that approximately 90 percent of the radioactivity used at their hospitals was in the form of Tc-99m, which has a half life of 6 hours6.944444e-5 days <br />0.00167 hours <br />9.920635e-6 weeks <br />2.283e-6 months <br />, and that most of the remaining radionuclides used have a half-life on the order of a few days. Twenty commenters noted the soluble or dispersible nature of patient excreta and five commenters suggested the dilution of patient excreta that occurs in the sewer system affords ample protection to the public and to the environment.

Four commenters remarked that, if NRG believes the regulation is adequate, as stated in the ANPR, there shoulfrnot be a need to modify the exemption for patient excreta. Two commenters predicted restrictions on the release of patient excreta into sanitary sewers would not provide a significant benefit to public health and eleven commenters suggested the current exemption creates no environmental or public health hazard. One commenter remarked that none of the six case studies presented in the ANPR indicated that patient excreta released into sanitary sewers had caused a significant dose to any individual. A representative of a large

• health care organization noted that no complaints had been made about the sewage from any of the organization's hospitals, although the hospitals' effluents were ~este.9 by sanitary system staff routinely. Another hospital representative expressed the opinion that hospitals should not 35

be required to monitor patient excreta because the practice causes undue anxiety in the patients, creates additional burdens for nursing staff, and is unnecessary because survey readings generally are low.

Re.sponBe.: NRG e.cknowledges th8 cnrrimen+.f:'rs' supp0rt for the ex13!T!pticn for patient excreta, which supports the withdrawal of the ANPR.

Comment: Fourteen commenters stated that elimination of the exemption would impose significant burdens on their facilities' operations. Commenters expressed concern about the costs of building holding tanks for excreta, building separate plumbing systems, retraining workers, and employing additional workers to manage patient excreta. One commenter remarked that facilities would also incur the cost of hiring professionals to assess their current waste management practices and to recommend changes that would be needed to comply with new regulations. Three commenters remarked that medical facilities may also incur the costs of increased NRC licensing fees and inspections. Several commenters suggested any net health benefits associated with eliminating the exemption could not justify the costs of controlling the excreta, particularly for patients being treated on an out-patient basis.

Seven commenters predicted the costs of compliance with restrictions on release of patient excreta into sanitary sewers would cause a -significant increase in health care costs for patients. Three commenters predicted that health care costs would increase both because of the increased infrastructure and labor required to manage patient excreta and because patients' hospital stays would be extended so that their excreta could be managed by hospital staff. A physician and member of the NRC's Advisory Committee on the Medical Uses of Isotopes (ACMUI) estimated that the national increase in health care costs would be approximately 4.5 billion doliars for patients undergoing therapeutic procedures and 62 billion dollars for patients undergoing diagnostic proceq_ures, as _of 1_ 9~4. _T~e ~merican _college of Nu~lear Physicians and the Society of Nuclear Medicine jointly estimated that elimination of the 36

exemption would cause an increase in health care costs of 5.9 billion dollars annually.

One commenter expressed the concern that medical facilities may stop offering nuclear medicine services to avoid the legal consequences that could result if patients did not comply

'!'!it!""!-restrictions OP. the release of excreta to sewer s~1sterns. Five cornr,enters predicted th::>t !t ..

would be difficult to compel patients being treated on an out-patient basis to store their excreta for decay or return it to a licensed facility. One commenter expressed the concern that strict controls over patients could infringe upon a patient's constitutional rights.

Several commenters expressed the concern that elimination of the exemption would impact patient care. Four commenters expressed the opinion that, if the exemption were eliminated, the costs or logistical difficulties associated with managing patient excreta would cause many facilities to discontinue offering nuclear medicine services and could cause the end of nuclear medicine in the United States. Three commenters expressed the concern that elimination of the exemption for patient excreta would limit patient access to diagnostic and therapeutic nuclear medicine services and five commenters expressed the view that inaccessibility of nuclear medicine services would be far more detrimental to public health than any adverse health effects that could be averted by eliminating the exemption for patient excreta. One commenter noted that many facilities already have eliminatec.l-some clinical procedures because of the lack of access to low level radioactive waste disposal facilities. Two commenters expressed the concern that eliminating the exemption for patient excreta would diminish the quality of care that patients received if facilities limited patient doses to comply with restrictions on the radioactivity of patient excreta released into sanitary sewers. One commenter expressed the concern that patients may decline beneficial medical procedures

. because of an objection to collecting or having someon*e else collect their excreta. One

• commenter note.d that pe,tient 1J1.1ell-being would b_e compromised if patien_ts ne_eged to remain in the hospital so that their excreta could be managed because it would prolong the time away 37

from their families and jobs. Another commenter suggested the current exemption for patient excreta should be maintained until the impact on health care could be assessed.

Response: NRG acknowledges the commenters' concerns about the potential costs, legal implic8.tinrJ.s, ::inctimpHcts on.patient c::i.re.Jhat may be caused by remD'I!rlQ the-exemption for patient excreta. The exemption will be maintained because the ANPR is being withdrawn for the reasons previously explained.

Comment: Three commenters suggested the effects of the exemption should be studied to determine if the exemption should be eliminated or modified. A representative of DOE recommended NRG maintain the exemption for the excreta of patients undergoing diagnostic procedures, but consider placing restrictions on the excreta of patients undergoing therapeutic procedures because they typically receive higher doses of radiopharmaceuticals. Another commenter remarked that it would be inconsistent of NRG to impose strict restrictions on the release of excreta by hospitalized patients if the excreta of patients being treated on an out-patient basis contributed more radioactivity to sanitary sewer systems. A representative of an association of POTWs in Minnesota stated that the organization is prepared to rely on NRG judgement about the appropriateness of the exemption once NRG has evaluated the amounts

• and types of radioactive materials released into sanitary sewers through patient excreta, but expressed concern that the ANPR indicated that the_ effects of the exemption had not been studied and would not be included in planned modeling efforts. The commenter also expressed the opinion that the safety of the exemption should be evaluated irrespective of the origin of the waste in medical uses. A representative of the New York State Department of Environmental Conservation suggested that a range of possibilities, including retaining the exemption, eliminating the exemption, and modifying the exemption, should be evaluated in an Environmental Impact Statemerit (EIS). The commenter stated an El~ would Rr9vide a "long-needed" record of the rationale for the decision to exempt patient excreta from the sewer 38

release restrictions and the expected impacts of the exemption on the environment and public health.

Response: NRG acknowledges the suggested modifications to the exemption of patient excreta.. and .the.~11ggestion that8.l'.1 EIS shou!d be perfmmed . .However,.those suggest!ons 'NH!

not be implemented because the ANPR is being withdrawn for the reasons previously explained.

Comment: Two commenters suggested releases of radioactive materials into sanitary sewers should be regulated uniformly, irrespective of the origin of the wastes. One of the commenters questioned why the ANPR specifically stated that doses from patient excreta were expected to be "far below the NRC's dose limit" when this description was equally appropriate for the discharges from other licensees. Another commenter remarked that, although it may be difficult for medical institutions to meet restrictions on the release of patient excreta, the releases should be regulated because they have been shown to contaminate sewage sludge.

Another commenter provided measurements of 1-131 in sewage and sludge in one municipality's POTW and expressed the concern that 1-131 could be a source of radiation exposure to sanitary system workers. The commenter also expressed the concern that, although it has a short halfclife, Tc-99m could cause significant radiation doses to workers exposed to sewage collection systems directly downstream of hospitals. In addition, the commenter expressed the concern that, because 1-131 is very soluble, most of the 1-131 that entered a POTW would be discharged in the treated effluent and that the POTW's effluent may, therefore, exceed NRG limits on the allowable releases of radioactivity to unrestricted areas .

The commenter also expressed concern that many municipalities are not aware that releases of patient excreta are exempt from NRG restrictions and can be a significant source of radioactivity in wastewater.

Response: NRG acknowledges the commenters' suggestion that the release of 39

radioactive material should be regulated uniformly irrespective of its origin. However, NRC believes the exemption for patient excreta is appropriate because of the potential biological and radiological hazards associated with alternate methods of managing patient excreta. Additional

... limitations 011 t'1e rnh'lase nf ~::'lti_P,nLexcrntFl into sanita~1.sewP-rs arP. not being imposed for th8 reasons previously discussed. NRC appreciates the commenter's concern that municipalities may be unaware of the potential for patient excreta to contribute to the radioactivity of wastewater and sewage sludge. Section 3.2 of the ISCORS recommendations on managing radioactive material in sewage sludge and ash (EPA 832-R-03-0028) alerts POTW operators that a significant amount of the radioactivity discharged to POTWs that serve medical facilities can be discharged in the form of patient excreta.

Comment: Two commenters suggested the exemption for patient excreta should be eliminated to minimize the release of man-made radioactivity to the environment. One commenter expressed concern about NRC's policy on allowing patients who had received nuclear medicine treatments to leave the hospital (described in NRC Information Notice 94-009). The commenter also expressed concern about specific incidents in which, the commenter believed, patients had not been warned that high residual radioactivity would result from the medical procedures they had undergone or"had been told that releasing excreta to a septic system would not cause adverse health effects. The commenter remarked that, although the radionuclides used in nuclear medicine procedures may be short-lived, each contribution of radioactivity to wastewater increased the potential dose to a member of the public. Another commenter noted that the contribution of radiopharmaceuticals to the radioactivity of wastewater increases as the number of procedures performed increases. The commenter also remarked that, if the half-lives of radioisoiopes used in niedicaJ procedures typically are short, as NRC stated in the ANPR, the burden of stor_ing the ex~reta until the radioac:tiyity_qecays_ to background levels should not be large.

40

Response: NRC acknowledges the commenters' concerns about the potential effects of the release of patient excreta into sanitary.sewers. However, NRC believes the current regulations are protective and has decided to retain the exemption and withdraw the ANPR for the reasons previously.explained .. The staff .110tes th8tcomments 9.bbut the regl!!ations governing the release of nuclear medicine patients from the hospital-are beyond the scope of this rulemaking.

Comment: One commenter suggested patient "vomitus" should be included in the exemption for the release of patient excreta into sanitary sewers explicitly. Two additional commenters mentioned sweat, saliva, blood, tears, and nasal fluids, but did not make any specific suggestions about how those fluids should be addressed in NRC regulations.

Response: The suggested change to the wording of the exemption will not be made because the ANPR is being withdrawn. However, NRC staff note that, in practice, the term "patient excreta" typically is understood to include situatio.ns when patients vomit.

Comment: A representative of a company that manufactures equipmenf ~hat removes radionuclides from hospital waste noted German law requires that radioactive materials be removed from hospital effluent before it is released into sanitary sewers.

Response: NRC appreciates the information provided by the comme;nter. However, the exemption for patient excreta will be retained because the ANPR is being withdrawn for the reasons previously explained.

Comment: Three commenters asked questions about the regulatory implications of potential modifications to the exemption of patient excreta from sewer release restrictions. Two commenters asked whether patients would be required to store .their excreta at home until it decayed to background levels of radioactivity or if theywould 6e req*uired to return-it to trie*

• medical facility at -which they. were treated. Two commenters asked whether the homes of nuclear medicine patients would need to be monitored to ensure that proper waste disposal 41

procedures had been followed. One commenter asked if the elimination of the exemption would result in changes to 10 CFR 35.75. The commenter also asked whether restrictions would apply to all patients treated with radiopharmaceuticals, irrespective of the dose they had by each patient and whether records of the releases would need to be maintained by the licensee.

Response: NRG acknowledges the many questions on this issue, but is not responding to them because the ANPR is being withdrawn.

Comment: One commenter suggested NRG should exempt the excreta of animals used in biomedical research from the restrictions governing the release of radioactive material into sanitary sewers.

Response: NRG notes that this comment is beyond the scope of this rulemaking.

(5) General Comments In addition to comments on the topics discussed in the ANPR, NRG received a number of comments on other aspects of the release of radioactive material into sanitary sewers. These comments are addressed in this section.

• ' - - Comment: Sixteen commenters expressed the opinion that the current regulations go'lerning the release of radioactive materials into sanitary sewers are adequate and should not be changed. To support this view, commenters remarked that the number of incidents of contamination is small compared to the number of POTWs receiving radioactive materials and that the doses received in those instances are believed to be low. Commenters also suggested the regulations should not be changed in response to a small number of cases of cfontamination, especially if some of those cases involved violations of the appiicable regulatic:ms. One commenter noted that modeling results described in NUREG/CR-5814 indicate that releases of radionuclides used in biomedical research are expected to result in 42

doses below the ALARA guidelines-in NRG Regulatory Guide 8.37. A representative of the Texas Department of Health suggested the regulations should not be changed unless modeling results demonstrated that exposures other than ingestion could cause an annual dose greater

- ___ than 5omSv (500 mr':\rn).- Two ~omm8ri~8r!=: suggested the rlsk of adverse h13alth effectg associated with exposure to radioactive material released into sanitary sewers should be evaluated in comparison to the health risks associated with exposure to hazardous chemical and biological materials in sewage and sludge. One commenter suggested the current limits are appropriate because the quantities and concentrations of radionuclides at affected POTW s appear to be within 10 GFR Part 30 limits for general licensees.

Response: NRG acknowledges the commenters' support for the current regulations, which supports withdrawal of the ANPR.

Comment: Nine commenters, including a representative of DOE, suggested the changes made to 10 GFR Part 20 in 1991 may have significantly reduced the potential for reconcentration of radionuclides in POTWs, and that resources should not be expended to address a problem that may have already been solved. Of these, five commenters noted that the ANPR did not include any information about contamination problems that had occurred since the modification of 10 GFR Part 20 and two commenters noted that most of the contaminants in the case studies presented in the ANPR were insoluble non-biological materials and would not meet current release criteria. Several commenters recommended NRG evaluate the effects of the lower discharge concentration limits and prohibition against discharging insoluble, non-biological materials into sanitary sewers before making additional changes to 10 GFR Part 20. One commenter expressed the opposite view and stated that the NRG should riot assume that the- changes made to 10 CFR Part 20 in 1991 would eliminate contamination of POTWs with licensed radioactive materials.

Response: NRG acknowledges the commenters' recommendation that it study the 43

effect of the changes made to 10 CFR Part 20 in 1991 on the amount of radioactive material at POTWs. The NRG staff notes that the ISCORS sewage sludge survey and dose modeling work were performed several years after the January 1, 1993, deadline for licensees to meet the

. .revised requirements and should reflect thr:>. effects of the 1991 re"i!3i0n of tr.e re~u!ati0n. -

Comment: Five commenters expressed the view that additional restrictions on the release of radioactive materials into sanitary sewers would not be consistent with efforts to keep doses ALARA. Several of the commenters predicted that doses to workers that were required to collect or prepare waste for disposal would be far greater than the collective dose that could be averted by more restrictive sewer release limits.

Response: NRG acknowledges the commenters' opposition to additional restrictions on the release of radioactive materials into sanitary sewers, which supports the withdrawal of the ANPR.

Comment: Four commenters stated that any additional restrictions on the release of radioactive material into sanitary sewers would have a significant negative impact on the facilities they represented. One commenter expressed the view that banning the release of radioactive material into sewers would impose a large financial burden on all biological research facilities and estimated that, as of 1994, alternative Llisposal methods would cost his company

$150,000 to $300,000 annually. A representative of a nuclear laundry stated that additional restrictions on the release of radioactive material into sanitary sewers could have a serious detrimental effect on his company and its customers if nuclear laundries could no longer operate. Another commenter suggested new restrictions should be implemented gradually by adding new restrictions during license renewals.

One commenter expressed concern that additional restrictions *on the release of radioactive material to sewers would eocumbl3r facilities that perform medical research, and requested that educational and medical research institutions be exempted from the regulations 44

because the long-lived radionuclides that had been detected in the cases described in the ANPR typically are not used by medical research facilities. The commenter also requested that, if medical research facilities were not exempted, more explicit guidance about the implications of the regulations on spedfic practices us'3c! in mediG:'11 r:eseai:ch faci!itles be provided by !'lP.C ...

Another commenter proposed that the regulation should explicitly permit disposal of medical diagnostic products in aqueous mixtures that contain less than 370 kBq (1 0 microcuries) of radioactivity and which are composed of isotopes with half-lives less than 61 days.

Response: NRG acknowledges the commenters' information about the burdens that could be caused by additional restrictions on the release of patient excreta into sanitary sewers, which supports the withdrawal of the ANPR. The staff notes that requests for exemptions of certain classes of facilities or types of waste are beyond the scope of this rulemaking. NRG acknowledges that guidance written specifically for medical research facilities would be helpful to some li~ensees, but does not have plans or resources to develop such guidance.

Comment: A representative of DOE expressed the view that the current rules are protective of public heath and safety and the environment, and noted that, if the provision for release of radioactive materials into sanitary sewers was not available, risks to the public would result from other waste management options. As an example, the commenter-predicted elimination of the release of radioactive material into sewers would cause an increase in traffic accidents because of the need to transport more waste to LLW disposal facilities. However, the commenter also recommended NRG increase inspections of licensees' releases into sanitary sewers and perform additional analyses of potential doses to members of the public and sanitary system workers to ensure that adequate safety provisions are in place to preclude accidental discharge of large quantities ot radioactive material. The commenter also recommend~d NR_G contact AMSA .and Jngustry trade gmups to obt~in_ additi_onal information about variations and trends in wastewater treatment technologies, practices, and regulations.

45

Response: NRG acknowledges the commenter's remarks regarding the risks that could result from additional restrictions on the release of radioactive material into sanitary sewers, which support the withdrawal of the ANPR. In accord with the commenter's suggestions, NRG

_ particip-8.t~ctin thP.-_l_8CORS SAW:=.i.ge sludge surve.y(NUREG-1775) and dose modeling report - _

(NUREG-1783}, the results of which provide a technical basis for withdrawing the ANPR. The staff acknowledges the suggestion regarding NRG inspection activities but notes the topic is beyond the scope of this rulemaking.

Comment: A representative of NIH stated that, although NIH is a large facility conducting both biomedical research and medical diagnosis and treatment, and its usage of some isotopes fluctuates considerably, NIH has been able to manage its radioactive liquid wastes in compliance with NRG regulations. The commenter also stated that NIH uses large, centrally-located tanks to hold short-lived radionuclides for decay, and that NIH has been granted an exception to the total quantity limits that allows it to discharge a total of 296 GBq (8

• Ci) annually.

Response: NRG acknowledges the commenter's information regarding the adequacy of the current regulations governing the release of radioactive material into sanitary sewers.

,,._

• Comment: A commenter who was a member of ACMUI as well as a physician and professor of Radiological Sciences at the University of California, Los Angeles, expressed several concerns regarding the possible changes described in the ANPR. The commenter expressed the opinion that NRG resources would be better spent changing other parts of 10 CFR Part 20 than by making the changes proposed in the ANPR. The commenter also stated that Agreement States had been reluctant to adopt the changes made to 10 CFR Part 20 in 1991 because of unspecified proble*ms with the revised rule. The commenter expressed -

concern that user_fees w~~e u_sed to support? _N~tional Coun~il on Radiation Prote9tion ~tudy of the number of various types of nuclear medicine procedures performed annually as of 1989.

46

The commenter also expressed concern that any change in NRC regulations governing the release of radioactive mate.rials into sewers would later be changed by an EPA rule, and that NRC licensees would, in effect, pay for a rule twice by paying both NRC user fees and paying

__ ,, taxe&, to support. Er A The commenter asked why the NRC had published the ANPR and expressed concern that NRC wasted licensees' time by asking for data regarding various nuclear medicine procedures. The commenter stated that the data had been given to NRC in 1990 and asked why NRC did not used these data to derive concentrations of various radionuclides in sanitary sewage. The commenter also suggested NRC could request data regarding concentrations of radioactive materials in wastewater and sewage sludge from POTWs in Agreement States. In addition, the commenter suggested NRC review any proposed changes related to medical uses of isotopes with the ACMUI and expressed an unfavorable opinion about NRC's program to regulate medical uses of radionuclides.

Response: NRC acknowledges the commenter's statements about the 1991 revision to 10 CFR Part 20 but notes that other parts of the regulation are beyond the scope of this rulemaking. A response to the commenter's displeasure at paying licensing fees to support this rulemaking is not needed b~cause the ANPR is being withdrawn. The same applies to the commenter's concern that EPA would impact a change in NRC's regulations. Because the ANPR is being withdrawn, that concern is no longer applicable to this issue.

NRC published the ANPR to invite comments and recommendations from interested parties on potential changes in the regulations governing the release of radioactive materials into sanitary sewers. In response to the commenter's concern about the time licensees may have spent responding to the ANPR, NRG notes that the-AN PR invited comment but did not re~L_!ire a response. In addition, NRC notes that the ANPR invited comment on a varie_ty of issues and was not limited to a request for information to support the derivation of 47

concentrations of radionuclides in sewage.

NRG acknowledges the commenter's suggestion that potential changes to the rule be discussed with the ACMUI, and the commenter's statements about NRC's program to regulate

. medical l!Bes of radk:inuclid'?-s .

Comment: Three commenters expressed the view that cases of contamination at POTWs demonstrate that the current regulations governing the release of radioactive material into sanitary sewers is inadequate. All three commenters expressed the concern that the regulations did not adequately protect the health and safety of POTW workers. In addition, a representative of AMSA expressed the concern that the current regulations could jeopardize the ability of POTWs to fulfill their environmental objectives. The commenter also expressed concern about NRC's involvement with existing cases of contamination and urged NRG to take a more active role in protecting POTWs from contamination with radionuclides.

Each of the three commenters expressed the opinion that the current regulations also fail to protect POTWs from the legal and financial consequences of contamination of POTWs and POTW biosolids with radionuclides. Two commenters noted that the public ultimately bears the costs associated with contamination of POTWs and one estimated that billions of dollars of public funds could be required to dispose of contamir,ated sludge and decontaminate POTWs.

A representative of the City of Oak Ridge outlined the history of contamination of the Oak Ridge POTW with Co-60, Cs-137, uranium isotopes, and 1-131 from 1984 to 1994. The commenter noted that, as of 1994, disposal of wastewater treatment sludge cost the City of Oak Ridge approximately $100,000 per year, primarily because of radioactive contamination. The commenter stated that, because of this expense, the city is in the process of implementing its own limits to controi releases of radioactive materiais ihto the sa*nita:ry..sewers and provided a reference that describes the approach that has been taken to conJn::>I Jc!di_oa_ctive materials through the municipality's industrial pretreatment program.

48

A representative of the Northeast Ohio Regional Sewer District noted that, although no significant health or safety problems had been found to result from the contamination at the district's Southerly Facility, the district has had to manage difficult regulatory issues and

.. con.r.ems from the public a11d. from workers th8.tbadcn'?t the district, e.~ of 1994, $1.5 rr:il!!o~.t,...,

resolve. The commenter remarked that the sanitary district had over one hundred thousand cubic meters (4 million cubic feet) of Co-60 contaminated ash at its Southerly Facility and had recently discovered contamination at another one of its POTWs. The commenter expressed the view that the District's problems were attributable to inadequate regulations or ineffective enforcement by NRC and suggested that major revisions to both 10 CFR Part 20 and to NRC's enforcement program were overdue.

Response: NRG acknowledges the commenters' concerns about cases of contamination and protection of POTW workers. However, NRC believes that the restrictions on the forms of material suitable for release and lower concentration limits established in the 1991 revision to 10 CFR Part 20 have reduced the potential for significant contamination of POTWs or sewage sludge with radionuclides. Although additional restrictions on the release of radioactive material into sanitary sewers will not be implemented, Section 7.2 of the ISCORS recommendations on management of radioactive materials in sewage sludge ai1d ash (EPA 832-R-03-002B) provides guidance to assist POTW operators in reducing sources of radiation entering their treatment facilities. Comments about NRC's enforcement program are beyond the scope of this rulemaking.

NRG acknowledges the information provided by the City of Oak Ridge regarding the POTW's industrial pretreatment program. Information about the program is summarized in Appendix F of the ISCORS recommendations on management of radioactive materials in sewage sludge and ash (EPA 832-R-03-002B).

Comment: A representative of a sanitary district stated that, contrary to the position 49

taken by NRC in the ANPR, many cases of contamination of POTWs are the result of relatively basic wastewater treatment technologies. In addition, the commenter expressed the view that NRC's emphasis on the concept of "reconceritration" as the cause of contamination problems is misleading and not~r.i that atone POTWin the district,. it appeared th_a~ partic!es at co,.60 were .

removed from the sewage through settling, as other solids are removed, rather-than through reconcentration of dissolved cobalt or agglomeration of fine particles. The commenter expressed the view that the new restrictions on the forms of materials suitable for release into sanitary sewers may p_revent many problems with insoluble materials such as Co-60 if the regulations are properly enforced.

Response: NRC acknowledges the commenter's concern that the term "reconcentration" was used in the ANPR to describe all processes by which the concentration of radionuclides in sewage sludge or ash could be increased on volumetric basis. NRC understands that radioactive materials may be concentrated by common wastewater treatment processes, as discussed in NUREG/CR-6289.

Comment: Seven commenters expressed the view that discharges of radioactive materials into sanitary sewers should be regulated locally. Two commenters suggested that,

• ,. I

. . *~

beci3tJse relatively few cases of contamination had been observed, it appeared that the cases \':."",. '

could be resolved without NRC involvement. One commenter expressed the view that local control would be easiest to implement if the problematic discharges involved other hazardous, nonradioactive materials.

Five commenters, including a representative of AMSA, expressed the opinion that POTWs should have the legal authority to establish local limits for the release of radioactive

• material into sanitary sewe"rs. Three of the commenters expressed the concern that, although ll}Unicipallties are held responsibl§l for the disposal or beneficial use of POTW sludge_, !he municapalities have no control over the radioactivity of materials discharged to the sewer 50

system that affect sludge quality. One commenter expressed the concern that the existing regulatory framework is inadequate because NRG maintains that the party in possession of the radioactive material is responsible for remediation, offers no assistance to POTWs that have

-been conta,mina.ter.! by 9. Jit::~nsee'<:: effluent, ~nd R-tate,~ the.tthe-AE.A*indicRtE!s that its.

regulations preempt more restrictive local regulations. The commenter expressed concern that NRG has indicated that this position would not change even if NRG had proof that material was illegally discharged by a licensee and that a POTW's only recourse to recover remediation costs is to take legal action against the discharger. One of the commenters suggested NRG should either assume responsibility for disposing of radioactive sludge generated in POTWs as a result of "errant discharge" from NRG licensees or allow POTWs to regulate the discharge of radioactive materials into sewer systems. The other commenter suggested that, in cases in which the reuse or disposal of sludge is restricted because of its radiological contamination, NRG .should cooperate with EPA to help affected POTWs establish local discharge limits to protect the traditional method of disposal or reuse of the biosolids .

. Another commenter stated that it was not necessary, feasible, or appropriate for NRG to develop new regulations that would limit the disposal of radioactive material into sanitary sewers because POTWs already hacJthe legal authority and mandate to establish and enforce appropriate pretreatment standards that would prevent contamination of POTWs or sewage sludge, pursuant to the Clean Water Act (33 U.S.C. 1317(b) and (d) and 1319} and EPA Clean*

Water Act Standards (40 CFR Part 403}.

Response: NRG acknowledges the commenters' concern about the power that local authorities have to regulate the release of radioactive material to their POTWs. The U.S.

Supreme Court has heid that, for certain activities covered by the AEA, Federal authority preempts other regulatory authori!ies whose purpose is radiation protection. It is difficult to predict whether unusual cost to the POTW caused by radioactive effluent discharges would be 51

,.t a sufficient reason to impose more restrictive discharge limits than those permitted under Federal law because there are no Federal cases in which the specific facts corresponded to the scenarios faced by local POTW authorities. More information on this issue is presented in Chapter 4 *ar.d- Sect:or- -7 .2 of tr.:; ISC ORS rscc:r.:T!e::dat:cr.::; on m::!~2.2~~ent c~ re.dia3.ct!ve

• materials in sewage sludge and ash (EPA 832-R-03-002B).

Comments regarding NRC's responsibility for the disposal of contaminated sludge are beyond the scope of this rulemaking. As discussed in Chapter 7 of the ISCORS recommendations (EPA 832-R-03-002B), in individual cases of contamination, legal counsel should be consulted to determine if dischargers may be liable for portions of remediation costs.

Comment: One commenter recommended NRG exempt POTWs from any regulations that would apply to material released into their systems because the potential benefits of regulating POTWs would not justify the costs.

Response: This suggestion is beyond the scope of this rulemaking.

Comment: Five commenters, including a representative of AMSA, expressed the view that POTWs should be able to apply the same type of pretreatment standards to radionuclides in licensees' effluent that are applied to toxic materials discharged into sewer systems by industrial dischargers as part of EPA's NPDES prograni':'-Commenters noted that local limits can account for the number of licensees discharging to a single POTW, the total flow into a POTW, and the effects of various treatment process on radionuclide reconcentration. Three commenters noted that, in general, local restrictions on discharges of pollutants to POTWs are established by determining an allowable load of a pollutant to a POTW that will not create a violation of the POTW's effluent limit and not interfere with disposal or reuse of the POTW's biosoffds,-and then allocating that limit among industrial facilitles tnat discharge effluent to the POTW. Two_commenters expressed the view that the same process should be used to develop individual limits for each radionuclide, taking into account each radionuclide's specific activity, 52

half-life, and solubility. One commenter noted that this procedure cannot be followed with radioactive materials because no "acceptable" levels of radionuclides in sludge have been established. Another commenter recommended NRG coordinate any future regulations affe.c.~in!J sanitary sewer discharges *_hf!~h EPA reqt~lr.erne~ts '!'or Clean We.te~ .ll,ctdischarges, .

including Categorical Standards, NPDES permits, and regulations pertaining to sewage sludges.

Two commenters suggested that, because setting limits for radioactive materials will be new to many POTWs, NRG should provide guidance on establishing local limits on the release of radioactive materials into sanitary sewers. A representative of AMSA suggested a number of topics that the recommended guidance should address and recommended NRG consider two EPA resources used to develop limits on industrial discharges to POTWs.

Response: This comment includes detailed recommendations about the creation of a program in which the release of radionuclides into sanitary sewers would be regulated by local, rather than Federal, authorities, and is beyond the scope of this rulemaking. Although guidelines for the development of local limits under such a program have not been developed, many of the topics the commenters requested be included in such guidance are included in the ISCORS recommendations on management of radioactive materials in sewage sltldge and ash (EPA 832-R-03-0028), as is information about local pretreatment programs established in Albuquerque, NM, St. Louis, MO, and Oak Ridge, TN.

Comment: One commenter was concerned that system-specific discharge limits could be difficult to implement if, as is done in the NPDES process, discharge limits are based on the "waste assimilative capacity" of the receiving waterway, which, the commenter stated, could be

• difficuit to determine. The commenter also expressed concern that licensees would need to*

o_btain prior approva! for sewer disc~arges, and that regulatory agencies would need to keep track of separate discharge allotments for each licensee and any changes to each POTW's 53

treatment processes. The commenter noted that an alternative to establishing system-specific discharge limits would be to set activity limits so low that regulatory limits or ALARA goals for public doses would be met, irrespective of the wastewater treatment process used, the capacity

. <of the receiving PQTVV, or the number of dischargers discharglng .to the P.OTW. T!le- - _, --

commenter noted that this approach would not require as much regulatory oversight and suggested these approaches should be evaluated in an EIS.

Response: NRG acknowledges the commenter's concerns about the difficulties involved -

with implementing system-specific discharge limits. An EIS that evaluates the alternatives will not be developed because the ANPR is being withdrawn for the reasons previously discussed.

Comment: One commenter asked for clarification as to how the revised rule would relate to NRG decommissioning standards and various EPA rules and suggested NRG hold public hearings on the issue.

Response: NRG is not responding to the request for clarification on the relationship between the proposed rule and EPA or NRG standards because the ANPR is being withdrawn.

Comment: Ten commenters expressed the view that any change to the regulations governing the rele_ase of radioactive materials into sanitary sewers should have a solid technical basis:-,Three commenters recommended NRC delay decisions about the need for modifications to the regulation until NUREG/CR-6289, which was incomplete at the time, was made available to licensees. Two commenters expressed concern that the ANPR was offered without a significant risk assessment. Six commenters recommended that any proposed change in the regulation should be based on a realistic assessment of either the collective dose or the risks to members of the public and POTW workers that the new regulations would avert. Two commenters expressedlhe concern that changes to the regulations would be made for reasons other th_an technjcal _reasoris, incl!,Jtjing regulatory con_vef!ienc::e, a percE!ptiqn of public _o_piniqn, or political pressure.

54

A representative of the New York State Department of Labor remarked that some of the regulatory changes proposed in the ANPR would be complex for both licensees and regulatory agencies to implement and, therefore, should not be undertaken without a without a firm excreta, all of the options discussed in the ANPR required more analysis before NRG would have sufficient information on which to base a decision. The commenter expressed the opinion that frequent changes in the same regulation are especially burdensome for licensees and urged NRG to perform the necessary analyses before changing the rule again. Representatives of the New York State Energy Office and New York State Department of Environmental Conservation encouraged NRG to develop an EIS to evaluate the options discussed in the ANPR. The representative of the New York State Department of Environmental Conservation remarked that the current regulations, including the revisions made in 1991, had never undergone a full environmental review.

Two commenters expressed the concern that the current limits on the discharge of radioactive material to sewers do not reflect the hazards radioactive materials could pose in a POTW or after release to the environment. The commenters recommended NRG initiate a study that would include a POTW hazard identification and assessment, exposure and toxicity assessments, and a risk characterization. The two commenters also recommended NRG study the fate and transport of radionuclides in sewers, POTWs, and the environment. A representative of the City of Oak Ridge provided a reference that discussed the fate and transport of radionuclides in the municipality's POTW. A representative of AMSA recommended NRG cooperate with EPA, POTWs, and affected industries to assess the exposure and contamination pathways 01' radionuclides, and the impact of radioactive rriateriais on wastewater treatment processes.

Response: NRG acknowledges the commenters' view that the 1991 revision to the 55

regulations governing the release of radioactive materials into sanitary sewers should have been based upon detailed risk analyses. As discussed previously, NRG cooperated with representatives of EPA and POTWs in developing the ISCORS survey and dose modeling project ta. a.~~e.~sJhe n=1dioacti""=i ~.0r1.tarninatirmJn.POTW.s.and pathwey~ for,.exp0B1Jre.af F;?OTV\f.

workers and members of the general public to radionuclides released into sanitary sewers. The results of these analyses served as the technical basis for the withdrawal of the ANPR. An EIS for the rulemaking will not be performed because the ANPR is being withdrawn for the reasons previously discussed.

Comment: Three commenters, including a representative of AMSA, recommended NRG study the extent of the use of sewer discharges and contamination of POTWs around the country. The representative of AMSA suggested that, because NRG had acknowledged that it did not know how many POTWs in the country were contaminated with radionuclides and because it would be inappropriate to develop national standards based on contamination in a few isolated cases, NRG should establish a task force composed of NRG and EPA staff as well as representatives of POTWs and licensees to study the nature and extent of radioactive contamination of POTWs nationally. Three commenters recommended NRG determine which licensees release radioactive material into sanitary sew8rs and two of these commenters recommended NRG make the information available in a national database. Of these commenters, one suggested the database should be similar to the EPA's Toxic Release Inventory and the other suggested the database should include information about the mass of each radionuclide discharged per year by each licensee, the volume of the licensee's discharge, and the licensee's POTW service area. A representative of one utility district expressed concern that, as*of 1994, the NRC had not be*en able to *provide a iis't of the licensees discharging into the district's sewer system an_d that the gistrict h~d,_ therefore, b~e_n _un~~I~ to initiate an appropriate monitoring program.

56

_)

Response: NRG acknowledges the commenters' request for a national database, but notes that a database that contains information about releases of radioactive material into sanitary sewers by licensees is not being developed. As discussed in Section 5.1 of the

... !SGORS recommendations-on management of.radloactlve me.teria!s ir.i se\l'!sge s!udge,ar.d ash (EPA 832-R-03-002B), POTW operators are encouraged to contact the applicable NRG Regional Office, appropriate State Radiation Safety Office, and any nearby DOE facilities if they have questions about the sewer releases of facilities in the POTW's service area that use radioactive materials.

Comment: One commenter requested that, because NRC had just begun to study the fate of radionuclides in POTWs and because NRC did not know which of its licensees discharged materials into sanitary sewers, a moratorium be imposed on the disposal of radioactive material into sanitary sewers until NRG had the information necessary to help POTWs develop protective limits.

Response: NRG notes that this comment is beyond the scope of this rulemaking.

Comment: One commenter expressed concern that the assumptions used in 10 CFR Part 20 ignored exposures to children, fetuses, elderly, people with existing body burdens of radioactive material, and individuals in other sensitive groups. The commenter expressed

• concern that the risk of birth defects from ionizing radiation had been limited to only two generations in NRG analyses and stated that the greatest number of birth defects will be seen in generations beyond the next two. The commenter also expressed the view that NRG should consider non-cancer and nonfatal cancer health effects in risk calculations and expressed concern that these effects were not considered in the promulgation of 10 CFR Part 20.

Response: The commenter's *remarks about NRO's development of standards for the-protection ~gainst radiation are beyond the scope of this rulemaking.

Comment: Three commenters recommended NRC perform a cost/benefit analysis of 57

~- alternatives to the release of radioactive materials into sanitary sewers before proceeding with a

.. rulemaking and two of those commenters expressed the view that the proposed changes could not be justified by either a risk analysis or cost/benefit analysis. One commenter urged NRG to

.... app!ythe.backfit prov\i;:.ir:ins thet-3.pply.topower rea.ctors.to a broe.c!er.si:::ope..,cf. r.u!s~e._kir!g -- - .

decisions, and expressed the view that the alternatives suggested in the ANPR could not be justified in a backfit analysis.

Response: NRG is not performing a cost/benefit analysis or risk analysis because the ANPR is being withdrawn for the reasons previously discussed. The staff note that the commenter's opinions about NRG's backfit provisions are beyond the scope of this rulemaking.

Comment: One commenter expressed the concern that limits based on overly-simplified dose models could be overly-restrictive and could cause unintended harm to the public by limiting beneficial uses of radioactive materials. The commenter suggested NRG consider the "total societal impact" of its release limits, and expressed the view that NRG and other regulatory agencies typically perform inadequate assessments of the financial impacts of their rules. The commenter added that NRG should not avoid this responsibility by claiming that the AEA does not give it the responsibility to evaluate the total societal impact of its rules, because evaluaNon of cost, benefit, and total societal impact is inherently included in the concept of maintaining doses ALARA.

Response: NRG acknowledges the commenter's concern about the adequacy of financial impact analyses performed by NRG and other regulatory agencies. NRG staff agree that, as defined in 10 CFR Part 20.1003, the term "ALARA" indicates consideration of societal and socioeconomic impacts.

• -comiilent: .. Five commenters expressed.the opinion that, in general,_any changes to the regulations should allow less radi9active material to be released into sanitary sewers. Reasons for this position included new information about the adverse effects of chronic exposure to low 58

levels of ionizing radiation, information about the synergistic effects of radiation and chemical pollutants, and concern about the cumulative effects of multiple sources of radiation on public health and the environment. Two commenters suggested that all radioactive waste should be

-isolated in secure stcm=:i.ge. or dispose.! faci!ifi9s ..~nother commenter stated that NRG sho1Jlc! not allow environmental build-up of multiple sources of radiation even if each, individually, could be dismissed as being minimal. One commenter stated that his organization had commented on the revision of 10 CFR Part 20 repeatedly and that it remains concerned that the allowable concentrations of many radionuclides in air and water increase.

Response: The ANPR is being withdrawn for the reasons previously explained.

Comments about the basis for NRC's standards for the protection against radiation are beyond the scope of this rulemaking.

Comment: Four commenters expressed the opinion that the potential burden that additional restrictions on the release of radioactive material into sanitary sewers would impose on licensees is secondary to the primary goal of protecting public health and safety and should be given little weight in the evaluation of whether additional restrictions should be established.

Two commenters expressed concern that, in the ANPR, NRG made several inquiries about the impacts of new restrictions on lieensees without expressing a similar interest in the potential*

impacts of the release of radioactive material into sanitary sewers on other parties. One of the commenters expressed the view that the concern for licensees may be misplaced because it is municipalities, and not licensees, that ultimately bear the costs of disposal of contaminated sludge and POTW decontamination. The commenter also remarked that it appeared to be more appropriate for licensees, rather than the public, to bear the expense of the disposal of radioactive materials used by iicensees. Tne other commenter suggested NRG should have soHcited comments reg?irding the potential impact_ of the r~gulations on public health, healthcare costs, contamination of agricultural land, restriction of land uses, and environmental 59

degradation. Two commenters stated that it would be inappropriate for NRC to allow any risk to members of the public to lessen economic or regulatory burden on licensees. Another commenter noted that, in cases in which contamination of a POTW has been discovered, I., licensees must recogniz:,::, thst s9fety of the c0mDJL!~i~1 ls m0r9 irr.port2.nt the.n the desire for a i

licensee to use its current disposal options.

Response: NRC acknowledges the commenters' concerns regarding the specific requests for comment in the ANPR. With regard to the consideration given to the potential effects of changes in the regulation on public health and the environment as compared to potential burdens on licensees, the NRC staff notes that a significant effort was made to study the potential effects of the release of radioactive material into sanitary sewers on the public and POTW workers in conjunction with the ISCORS reports that were described previously.

Comments about the basis for NRC's standards for the protection against radiation are beyond the scope of this rulemaking.

Comment: Six commenters suggested that detection of radionuclides at a few POTWs is an insufficient reason to impose additional restrictions on the release of radioactive material to sanitary sewers. These commenters stated that radioactivity can be measured at very low levels that are not expected to cause a significant advers0 health effect for any individual. One commenter stated that lowering release limits to values that are significantly lower than limits needed to protect the public makes it more difficult for licensees to assure compliance of medical research and clinical staff with radiation safety procedures and undermines the public's confidence in realistic exposure or activity standards. Another commenter recommended NRC acknowledge that the risks caused by radioactivity in sewage sludge are small compared to the risks associated with the extra handiing and transportat101l ot waste *Iiiatwould occur if releases of radioactive material to sanitary sewers were eliminated.

One commenter also suggested that, because radioactivity can exist in sewer systems 60

• and POTWs without causing a significant dose to any individual, and because there are beneficial uses of radioactive materials, that it might be better to attempt to build public acceptance of the current practices than it would be to lower release limits or eliminate sewer di.c;chargP-.- Anothercomrn8nter. BuggeRterl Jni::idents ofc011t~rrilnation ~hrJu!r.Lb13 handled lr:- a _

consistent, routine way without undue alarm. A representative of DOE predicted that any discovery of radioactive contamination of sewage pipes or sewage treatment plants is likely to result in regulatory concern, even if the possible doses are tiny, because it may take time to determine whether the contamination poses a threat to public health and safety.

Response: NRC acknowledges the commenters' opinions, which support the withdrawal of the ANPR. The staff acknowledges the commenters' recommendations about proper treatment of cases of contamination, but notes they are beyond the scope of this rulemaking.

Comment: Three commenters addressed the potential for accidental releases of radioactive material into sanitary sewers. One commenter hypothesized that the case studies presented in the ANPR may have been the result of abnormal events and expressed the opinion that no amount of regulation, planning or notification can prevent inadvertent releases that result from system failures or other errors. Another commenter suggested NRC should realize that, irrespective of its regulations, an individual is likely to find a way to def&at-

"reasonable safeguards." Another commenter expressed concern that the modeling results described in the ANPR did not account for the potential for accidental releases in excess of the 10 CFR Part 20 limits and suggested the reported calculated doses may be underestimates.

Response: NRC acknowledges the commenters' statements about the possibility of accidental releases. NRC staff note that its inspections are designed to ensure licensees' operations are conducted safeiy and in-accordance with good practices ana iicense- conditions.'

With respect to the commenter's concern that the dose modeling results discussed in the ANPR do not include the effects of accidental releases, NRC staff note that the doses estimated in 61

,, NUREG/CR-1548 did not include the potential effects of accidental releases; however, the doses reported in the ISCORS dose modeling report (NUREG-1783) were based on observed levels of radioactivity measured in conjunction with the ISCORS sewage sludge survey

__ ____ __ (NUREG-1.77'.5)-a.nd, therefwe, n::ifler.t any acc.;idental m!ee.ses thi:it rriay h::i."9 beer, IT!!:'.dc, to the 313 POTWs surveyed.

Comment: Seven commenters addressed LLW disposal. Four commenters noted that additional restrictions on the release of radioactive materials to sewers would increase the amount of low level radioactive waste that would need to be disposed of in some other way.

Two commenters recommended NRG evaluate the options proposed in the ANPR in the context of the risks associated with the disposal of low level nuclear waste and the limited capacity of LLW disposal facilities. Two commenters noted that many licensees had, as of 1994, very limited or no access to LLW disposal facilities and one of the commenters noted that licensees without access to a LLW disposal facility would ne_ed to store waste on site indefinitely. Three commenters noted that additional restrictions on the release of radioactive materials into sanitary sewers would be especially burdensome because the facilities they represented lacked access to LLW disposal sites. One commenter stated that sewer disposal is the primary way

-, -*:*1 that ma;;,y medical research and biotechnology laboratories minimize generation of LLW.

One commenter expressed the concern that the use of sanitary sewer disposal of radioactive material would increase because of the high cost and limited availability of LLW disposal. The commenter noted that the release of radioactive material into sanitary sewers itself can lead to the creation of large volumes of LLW by contaminating sludge. Another commenter opposed the implication that sanitary sewer disposals would be used as a means of relief from the relaiive inaccessibiliiy of LLW disposal and noted that most types OT LLW do not meet the requirements for release into sanitary sewers.

Response: NRG acknowledges the commenters' concerns regarding the impact that the 62

_J

• proposed changes would have because of some licensees' lack of access to LLW disposal facilities. These comments support the withdrawal of the ANPR.

NRG also acknowledges the commenter's concern that limitations on LLW disposal staff notes that the results of the ISCORS sewage sludge suNey (NUREG/CR-1775) do not indicate that the frequency of POTW contamination incidents has increased since the commenters' remarks were made in 1994.

Comment: Five commenters expressed the opinion that licensees should bear all costs associated with waste disposal. One commenter suggested NRC's descriptions of case studies should include a description of the financial costs associated with the contamination and should indicate the party paying the remediation costs. Two commenters stated that NRG licensees should bear the costs of data collection, data reporting, and worker training needed to implement any new NRG studies or regulations needed to protect POTWs from contamination.

Two commenters expressed the view that licensees should pay to have monitoring equipment installed at POTWs.

Response: NRG acknowledges the commenter's suggestion that NRC's descriptions of case studies should include infer.nation about the economic aspacts of the contamination and notes that some information about remediation costs is provided in Section 1.2 of the ISCORS recommendations on management of radioactive materials in sewage sludge and ash (EPA 832-R-03-002B). Comments regarding the costs associated with implementation of new sewer release restrictions are moot because the ANPR is being withdrawn.

Comment: Six commenters expressed opinions about NRG enforcement actions. A represeh'iative of DOE stated that it was unciear whether one or more of the incidents described in the ANPR involved violations of the regulations, and suggested enhanced inspections, and not additional rulemaking, would be the most appropriate way to eliminate contamination of 63

111.*'

J II POTWs. Three commenters suggested NRG or POTWs should verify licensee's reported discharges into sanitary sewers and one commenter suggested compliance with NRG regulations should be demonstrated at the licensee's outfall into the sanitary sewer system so

_ .that POTWs.would no\ beJmpacted ::ind.wQulrinot need to implem'?.nt special controls. Two __

• representatives of POTWs noted that POTWs routinely sample the effluent of major industrial users as part of their industrial pretreatment programs. Another commenter suggested NRG should assist POTWs with monitoring of licensee's effluents and enforcement of the discharge limits.

Response: NRG notes that suggestions about inspection and enforcement activities are beyond the scope of this rulemaking.

Comment: Six commenters made specific suggestions about monitoring. Two commenters suggested licensees' outfalls and potable water intakes should be monitored, and three. commenters suggested monitoring also should occur at POTWs. One of the commenters that advocated monitoring at POTWs expressed the view that monitoring Would limit uncertainty in model results and would facilitate the study of the effects of influent radionuclide form and quantity on POTW worker doses. The commenter also suggested licensees should be encouraged to provide dosimetry and elementary radiation safE:Jfy training to POTW workers.

One commenter expressed the opinion that radionuclides in licensees' effluents should be monitored to record the highest concentrations discharged and facilitate a regulator's ability to link discharges with their sources. Three commenters suggested the radioactivity of sewage sludge should be monitored. One commenter expressed concern about the radioactivity of an engineered wetland used to treat wastewater in his town.

- -Response: Recommendations regarding* iocationsforrnonitoring a*iicens'i:3e's efflu*ent are beyond the scope of the proposed rulemaking.

Comment: A representative of the New York State Department of Environmental 64 L __

• Conservation recommended that the Notice of Proposed Rulemaking for any change to the regulation governing the release of radioactive material into sanitary sewers notice, for public comment, the compatibility category NRG intends to apply to each provision so that Agreement

. _ .States and other interested pE1rties cF.tn participate in .decisions about cr.,mpatlbility .

requirements. The commenter stated that, as of 1994, Agreement States were required to develop regulations that were compatible with the revised 10 CFR Part 20 without NRG having determined compatibility requirements and stated that this type of situation must not recur.

Response: NRG acknowledges the commenter's recommendation that intended compatibility categories be included in Notices of Proposed Rulemaking. Compatibility categories for the options discussed in the ANPR are moot because the ANPR is being withdrawn.

Comment: One commenter expressed a number of concerns about the case studies described in the ANPR. Concerns raised by the commenter included specific exposure pathways that may not have been included in the dose analyses, the appropriateness of NRC's comparison of doses with background radiation, and the concern that calculated doses to individuals could have been higher if the sludge to which they were exposed included radiation from multiple sources. The commenter expressed the view that radioactivity in the emvironment may increase because of human activity, and that it would be inappropriate to consider manmade contributions of radioactivity to the environment in the calculation of "background" radiation, or to allow releases because they would be minimal in comparison to background radiation. The commenter*also remarked that the cases of contamination that had occurred in Washington, DC, and Cleveland, OH, indicated the potential for contamination to be significant to large popUlations. In *addition, "the eommente*r asked specific questions about the

• as~umptions _used to calculate the doses resulting from the case studies discussed in the ANPR and what sources of radiation NRC included in its calculation of "background radiation".

65

Response: The commenter's concerns about the doses calculated in the case studies are no longer applicable because more recent studies served as the technical basis for the withdrawal of the ANPR. NRG acknowledges the commenter's concern regarding c_qntc1,mination at P~:nws'. The c_omme~ter'!3 specific qui3s!io_~s about the modeling assumptions used to calculate doses for the case studies discussed in the ANPR are addressed in NUREG/CR-1548. NRG notes that its definition of "background radiation", provided in 10 CFR Part 20.1003, excludes contributions of radioactivity fr(?m source, byproduct, or special nuclear materials regulated by NRG.

For the reasons cited in this document, NRG withdraws this ANPR.

Dated at Rockville, Maryland, this // day of t!>e:; T ,2005.

For the Nuclear Regulatory Commission.

tive Director for 66

DOCKETED US( RC NUCLEAR ENERGY I NST I TUTE

• 94 AUG 18 P5 :14 Felix M. Killar, Jr.

DIRECTOR, MATERIAL Free: ~.r-  ;;EcHETMrYllCENSEES PROGRAMS Augu~ oocll'f\ -~I I ~'ll u

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Mr. Samuel J. Chill<

Secretary U.S. Nuclear Regulatory Commission Washington, DC 20555 ATTENTION: Docketing and Services Branch

SUBJECT:

Advance Notice of Proposed Rulemaking: Disposal of Radioactive Material by Release into Sanitary Sewer Systems 59 Federal Register 9146 (February 25, 1994)

Request for Comments

Dear Mr. Chill<:

The Nuclear Energy Institute (NEI) 1 submits this letter and enclosed comments on behalf of our nuclear material licensee membership. The nuclear industry recognizes the necessity to regulate the disposal of radioactive materials into sewage treatment facilities .

It is not clear, however, that significant change to the existing regulation is needed.

While six incidents of contamination are cited in the subject Federal Register notice, they all occurred before the NRC modified 10 CFR Part 20, imposing additional restrictions on disposal of radioactive material into sewage treatment facilities. It seems prudent for the NRC to stay the course in retaining the current regulatory system of limiting the concentrations and quantities of radioactive materials that may be disposed into sewer systems.

We believe that NRC licensing of sewage treatment facilities would be counter-productive. On the infrequent occasion where treated sewage yields unacceptable radioactive concentration levels in ash or sludge, the NRC should consider imposing 1NEI is responsible for coordinating the efforts of all utilities licensed by the NRC to construct or operate nuclear power plants, and of other nuclear industry organizations, in all ~tters involving generic regulatory policy issues and the regulatory aspects of generic operational and technical issues affecting the nuclear industry. NEI's members include every utility licensed to operate a commercial nuclear power plant in the United States, the major nuclear steam supply system vendors, major architect/engineering firms, fuel fabrication facilities, materials licensees and other holders of NRC licenses, and other individuals and organizations involved in the nuclear energy industry.

1 776 I STREE T, NW SU ITE 4 00 WAS H IN GTON , DC 20006 - 370 8 PH O N E 202 739 . 8000 FAX 202 785 4 0 1 9

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Samuel J. Chilk August 16, 1994 Page 2 more restrictive license conditions on the contributing organizations. This notwithstanding, it may be prudent for the NRC to consider ways in which the regulatory system might be maximized, resulting in the potential modification of quantity limits for some radionuclides (e.g., raising some and lowering others). It is interesting to note here that over 99 percent of radiopharmaceutical activity is composed of radionuclides with half-lives of less than three days; therefore, these radioactive mateials would decay away within 30 days.

We appreciate the opportunity to comment on this important issue and would welcome the opportunity to discuss our comments further with appropriate NRC staff members.

Sincerely, fJl:;Al(;f}fL.-)

Felix M. Killar, Jr.

FMKjr/RCE:slr Enclosure c: Radiopharmaceuticals and Radionuclides Committee Facility Operations Committee

NEI Comments on the Advance Notice of Proposed Rulemaking: Disposal of Radioactive Material by Release into Sanitary Sewer Systems I. 10 CFR Part 20 has been recently modified to reduce the concentrations of radionuclides that may be discharged to sewer systems, and to further restrict the materials allowable for discharge to soluble material and dispersible biological material. It seems logical for the NRC to, at a minimum, delay any regulatory changes pending a study to determine the effect(s) of the changes to Part 20.

2. In the six incidents cited, it is unclear whether all resulted from activities carried out in compliance with the older regulations, or whether one or more of the incidents involved violations of the regulations. It seems, therefore, inappropriate for the NRC to respond to individual violations of regulatory requirements by changing regulations for all licensees.

3. In determining appropriate discharge limits, the NRC should consider distinguishing between those radionuclides and chemical forms that significantly concentrate in sewage treatment plants sludge and ash, and those that do not.

4. The NRC approach of basing the concentration limits on ingestion of water taken from the outfall of a discharging facility seems overly conservative and bounding.

The current model assuming direct drinking of licensee effluent is not a plausible exposure path. The model needs to realistically consider the actual influent to the plant from both licensees and other users to determine more realistic dilution factors .

The model should consider that sewage contains many materials more hazardous than

- radioactivity that require isolation and special handling to avoid personnel exposure.

5. It seems that Ohio's request for 24 hour2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> notice on radionuclides released to the sanitary sewer is impractical since every user, including households, releases small amounts of radionuclides every time effluent is disposed in the sewer. It is more reasonable to notify sewage treatment plants if large accidental releases occur.

However, this reporting capability already exists.

Department of Public Utilities James P. Joyce, P.E., Director DOC KETED QJ USNRC ~

July 13, 1994 *94 JUL 18 P3 :28 OF FICE OF ..,E.(:RE 1ARY OOCKET :t*r l S'"-R /ICi The Secretary of the Commission BRAtCH Nuclear Regulatory Commission Washington, DC 20555 DOCKET NUMBER Attention: Docketing and Service Branch . . * *---~r-o RULE PR 2. O

(§Cf FR 11LJ9

Subject:

February 25, 1994 ANPR

Dear Secretary:

Although the published deadline for receipt of comments has passed, the Division of Sewerage And Drainage (DOSD) of the City of Columbus, Ohio wishes to provide its opinion on the proposed changes to 10 CFR part 20 as published in the February 25, 1994 Federal Register advance notice of proposed rule making by the Nuclear Regulatory Commission. The focus of DOSD's concern is the concept of being held responsible for ultimate disposal of and quality of biosolids generated by municipal wastewater treatment processes without control of the radioactive character of materials discharged to the sewer system that affect the quality of those biosolids.

In the USA, the primary regulator, and in most instances the exclusive regulator of radioactive materials (including waste materials) is the Nuclear Regulatory Commission (NRC) .. The NRC is currently under no obligation to share regulatory authority

• or discharge monitoring data obtained regarding radioactive discharges to the environment. In particular regulation and data collection on radioactive discharges to the nation's sanitary sewers. is not shared with the owners and/or operators of those sanitary sewer systems. The proposed regulatory change does not rectify this critical shortcoming of the nuclear regulatory regime.

Utilities Complex 910 Dublin Road Columbus, Ohio 43215-9060 Director's Office 614/645-6141 Electricity Division 614 / 645-8371 TDD: 614 / 645-6454 Sewerage and Drainage Division 614/645 -7175 FAX: 614/645-3801 TDD: 614/645-6338 Water Division 614 / 645- 7020 FAX: 614/645 -8177 TDD: 614/645-7188 The City of Columbus is an Equal Opportunity Employe e, OWi edged b y card.................

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Secretary of the NRC July 13, 1994 page 2 of 3 If nuclear material discharged to a Publicly Owned Treatment Works (POTW) is concentrated in treatment process sludges (and it is). and that concentration effect results in the sludge having a sufficiently high radioactive contamination that it becomes unacceptable for beneficial reuse in land application programs. the burden of that liability lies with the POTW and not with the original radioactive waste generator. Under current and proposed regulatory regimes. the exclusive regulator of radioactive discharges is the NRC. This seat of authority does not provide the POTW with the necessary tools to protect its beneficial biosolids reuse programs. The Division of Sewerage and Drainage of the City of Columbus Ohio opposes mandates that are imposed without concomitant authority to control the circumstances prerequisite to managing the associated liability. In other words. if the POTW is going to be accountable for the level of radioactivity in its recyclable biosolids. it must be accorded the authority to regulate discharge of radioactive nuclides to the sewer system.

The local POTW should be all owed to establish. with the technical assistance of the NRC, what levels of radioactive discharges to the sewer system would be allowable in the particular local system in question. Methodology similar to the Headworks Loading Analysis should be applied. as in the case of other toxic.

conservative pollutants discharged to local POTWs. Subsequent to establishing an allowable Headworks loading. the loading should be equitably distributed to the known local radionuclide dischargers by the POTW. The NRC could then assist the POTW with monitoring and enforcement of the established discharge limits. Since the effects of radioactivity are more or less cumulative and affect biosolids most severely. limits might be best expressed in time units of per week or month instead of per day as for more acutely toxic parameters.

Minimally. the NRC must share the regulatory authority with POTW and the POTW must be provided consistent, routine monitoring

Secretary of the NRC July 13, 1994 page 3 of 3 information regarding the level of radioactive nuclide discharge to the sewer system from each contributor. If NRC is sampling and collecting its own information that information should be shared with the POTW, and if the dischargers are performing self-monitoring. the POTW should be copied on any reports submitted to the NRC.

Unless the POTW has regulatory control over discharge of radioactive nuclides to the sanitary sewer system, it should 1iQI be held accountable for the presence of radioactivity in its treatment process byproducts. Responsibility without authority is NOT a viable scenario. NRC should either assume responsibility for disposing of radioactive sludges generated in POTWs as a result of errant discharge from NRC regulated dischargers or allow the POTWs to regulate discharge of radioactive materials to the sewer system.

If there is need for clarification or expansion of information presented in this commentary letter I can be reached during normal Eastern Daylight Time working hours at (614)-645-7429. Thank you for consideration of these comments.

Sincerely, DIVISION OF SEWERAGE AND DRAINAGE Ronald F. Scott Assistant Administrator, Operations RFS:RWG CC: J.Francis, Columbus DOSD Paul Novak, OEPA Surface Water file Filed : [ RWG]b: & C: \IIIPWI N60\'JP00CS\erfs0629. 1 tr

fti KAISER PERMANENTE DOCKETED USHRC Executive Offices, Ordway Building "94 Jl. l 1 P5 :13 OFFICE F SECRETA~Y DOCKETlf G& SERV1cE BRANCH July 7, 1994 The Secretary of the Commission U.S. Nuclear-Regulatory Commission Washington, D.C. 20555 Re: Comments on Advance Notice of Proposed Rulemaking - Disposal of Radioactive Material into Sanitary Sewer Systems

Dear Madame/Sir:

On behalf of Kaiser Permanente, we appreciate the opportunity to comment on the above-referenced advance notice, which was published in the Federal Register on February 25, 1994.

Kaiser Permanente is the largest health maintenance organization in the United States.

Kaiser Permanente owns and operates hospitals in four states and medical offices in 16 states and the District of Columbia.

We wish to comment on two of the questions posed by the NRC. First, should the NRC prohibit the discharge of tissue samples and other non-soluble radioactive materials? Second, should the NRC continue to exempt from regulation patient excreta that may contain radioactive materials as a result of nuclear medicine diagnosis or treatment?

In our opinion, the NRC should not prohibit the discharge of tissue samples and other non-soluble radioactive materials, and it should continue to exempt patient excreta from regulation. The basis for both of these opinions is set forth below:

Currently the clinical practice of nuclear medicine (as distinguished from academic research) employs the use of radionuclides which are short-lived, i.e., that have half-lives of less than 90 days. In fact, a survey of 10 hospitals in Southern California revealed that at least 95% of the radiophannaceutical activity received by the facilities was from Technetium 99, which has a J:\ZEMELMA\RADI02.DSP Kaiser Foundation Health Plan, Inc.

One Kaiser Plai.a Oakland, California 94612 510-271-5910 SEP 2 8 1994 .

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half-life of 6 hours6.944444e-5 days <br />0.00167 hours <br />9.920635e-6 weeks <br />2.283e-6 months <br />. Greater than 99% of the radiopharmaceutical activity received was from radionuclides with half-lives of less than 3 days.

Most of the radionuclides are excreted from the body in the urine. Sweat, stool, saliva are other sources, as are small quantities of residuals from preparation and cleaning of equipment.

The discharge of non-soluble radioactive materials, if any, is incidental to discharges of soluble materials.

Alternative methods of disposing of these wastes are impractical. First, it would be virtually impossible to identify and regulate persons entering a medical facility that had received radionuclides at home or at another facility. Second, capture and containment of nuclear materials in excreta would be hazardous, extremely difficult and would constitute a costly and unnecessary burden on health c.:ire providers. Third, r~diopharmaceuticals are often provided on an out-patient basis, and requiring patients to capture, store, and return their body waste to medical facilities would be difficult to enforce and would risk exposing patients and the public to biohazards.

Although Kaiser is the largest owner and operator of hospitals in California, and sewer discharges from its hospitals are routinely tested by local sewage treatment plant personnel, I am not aware of a single complaint or citation regarding the discharge of radionuclides from Kaiser Permanente facilities to the sewer. Apparently, because of both the rapid decay of nuclear medicine radionuclides and because of the rapid, massive dilution of radioisotopes once they are discharged into the sewer system, the discharge of nuclear medicine radionuclides from Kaiser Permanente facilities to sewer systems has not posed any significant problem at sewage treatment plants.

In summary, the risk to hospital personnel and the public of capturing, containing, transporting and disposing of radioactive excreta would be much greater than the current practice of discharging it to the sanitary sewer system. Similarly, it would not be wise from a risk perspective to require health care providers to isolate non-soluble radioactive wastes from soluble radioactive wastes.

Sincerely, KAISER FOUNDATION HEALTH PLAN, INC.

By: ~--  :::::----.....

k S. Zemelman ~

Counsel J :\ZEMELMA\RAD102.DSP Department of Energy DOCKETED j __

Washington , DC 20585 us C t'()

I J1.1-V\ 2. I

'JUN 1 3 1994

'94 Jl-15 P4 :15 OCKET NUMBER -"?~\~

Samuel J. Chi lk, . secretary PROPOSED RULE of the Commission ( ...;....;.,;;._!......r-,-._-_.;,

U. s. Nuclear Regulatory Commission SCf FR q I'-/ 6)

Washington, DC 20555 Attention: Docketing and Service Branch

Dear Mr. Chilk:

This letter encloses comments in response to the Commission's 25 February 1994 Advance Federal Register Notice (FRN) of Proposed Rulemaking on disposal of radioactive material by release into sanitary sewer systems (59 FR 9146).

It is not clear that significant change to the existing regulation is needed. Although we note the six incidents of contamination cited in the FRN, we also note that these incidents all occured before NRC's recent modifications to 10 CFR Part 20 that, among other things, have already imposed additional restrictions on disposal of radioactive material i nto sanitary sewers. In any case, it would appear that the best approach would be to retain the current regulatory system of limiting the concentrations and quantities of radioactive materials that may be disposed into sewers. Nonetheless, it may be prudent to consider ways in which the regulatory system might be optimized, which might result in modified quantity limits for some radionuclides (e.g., lowering some while raising others).

If you have questions about our comments please contact Mr. G.

Roles at 202--586-0829.

Ra ond F. Pell Director Office of Environmental Guidance Enclosure S:P 2 8 1994_

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Comments on NRC Advance Notice of Proposed Rulemaking on Disposal of Radioactive Material by Release into Sanitary Sewers The sewage disposal provision in 10 CFR Part 20 should be retained and applicable to all licensees. Disposal of negligibly small quantities of radioactive materials into sanitary sewers does not cause significant risks to public health and safety and the environment. If the provision was not made available to licensees, then comparable risks to the public might result from other waste management options (e.g., transporting waste to LLW disposal facililties, resulting in non-radiological risks from traffic accidents).

Notwithstanding this, several incidents have been recorded where radionuclides have been detected at sewage treatment plants in activity concentrations elevated above background. This has led NRC to issue the Advance Notice of Proposed Rulemaking in a 25 February, 1994 Federal Register Notice (FRN, 59 FR 9146).

However, we wonder whether a major change is needed in NRC regulations at this time. All the incidents cited in the FRN occurred under less restrictive requirements than those that are going into effect this year. As NRC notes in the FRN, 10 CFR Part 20 has already been modified to reduce the concentrations of radionuclides that may be discharged to sanitary sewers, and to further restrict the materials allowable for discharge to soluble material and dispersible biological material. (Formerly, any dispersible material was allowed.) It is also unclear whether all incidents resulted from activities carried out in compliance with the older regulations or whether one or more of the incidents involved violations of the regulations.

Therefore, we suggest that NRC proceed cautiously. Besides the revised Part 20 requirements, significant gain might result merely from increased focus on this area when inspecting licensees. In any case, it would appear that the best approach would be to retain the current approach of limiting the concentrations and quantities of radioactive materials that may be disposed into sewers. Nonetheless, it may be prudent to investigate the possible doses that could occur from particular exposure pathways to determine whether the regulatory system could be optimized. Allowable release quantities of some radioisotopes might be reduced while others might be raised.

Also, in response to the FRN, we have prepared four general comments addressing the four issues identified by NRC: (1) form of material for disposal; (2) total quantity of material; (3) type of limits; and (4) exemption for patient excreta. We have followed these comments with discussions of some additional issues.

2 Form of material released. It is reasonable to limit the materials that may be discharged to sewers to soluble and dispersible biological materials, which would be expected to readily decompose.

However, it would be unreasonable to assume that licensees would never dispose of insoluble or nondispersible materials into sewers. Honest mistakes may be made. Perhaps more significantly, it would be unreasonable to assume that the chemical forms of disposed materials would remain the same after discharge into a sewer. Chemical interactions might cause some materials to precipitate within or plate onto sewer pipes. This might cause a risk to workers if sewer pipes ever require replacement or repair. Perhaps more significantly, NRC should expect that advances in chemical processes at sewage treatment plants will increasingly result in concentration of radioactive materials into treatment sludges, as sewage treatment facilities strive to further decontaminate wastewater before discharge. To our understanding, to comply with EPA's regulations under the Clean Water Act, most wastewater treatment plants use primary and secondary treatment systems. Increasing numbers of plants are installing tertiary treatment systems.

Other than tritium and perhaps a few other isotopes, it would be prudent for NRC to assume that at most sewage treatment plants to be operated in the future, radioactive isotopes contained in wastewater processed by the plants would be retained in sewage sludge (or perhaps plate out on equipment surfaces). This might result over time in potential risks to sewage treatment plant workers as well as to those incinerating or using sewage sludge.

On the other hand, it would not be wise to assume that this situation is presently always the case. At many cities older sewage systems are designed so that sewage may be sometimes discharged without treatment, generally during high precipitation 1

events (combined sewage overflows). Of course, discharge of radioactive material during combined sewage overflow events would be diluted to a greater extent than under normal circumstances.

Total quantity of material. The total quantity of radioactive material is probably the most important consideration. It is the only sure way to preclude a possible accumulation of radioactive material in sewer pipes near the licensed facility, and the only sure way to preclude excessive concentration of radioactive material in sewage sludge. It addition, it is by far the easiest approach to regulatory control, by licensees as well as by NRC 1

The Environmental Protection Agency recently issued a national policy statement on controlling discharges from combined sewer overflows through the permit program under the National Pollutant Discharge Elimination System (59 FR 18688, 19 April 1994.

3 and state regulatory agencies.

The issue of multiple licensees releasing radionuclides to the same sewage system merits consideration. Although it might be argued that releases by multiple licensees could produce a cumulative effect in a single sewage system, we suspect that this situation would most likely arise in urban areas having very large sewage systems and large volumes of wastewater and sludge.

As such, any cumulative effects of multiple licensees would be diluted by the larger quantities of wastewater and sludge.

Types of limits. The Commission's approach of basing the concentration limits on ingestion of water taken from the outfall of a discharging facility would appear to be conservative and bounding. DOE knows of no data, statistical or anecdotal, about the propensity for humans to knowingly consume sewage water. DOE does suspect, however, that such consumption would not occur chronically, which leads us to agree that an annual 500 mrem dose would seem more appropriate as a limit than an annual 100 mrem dose.

It is less obvious that the sewage-consumption assumption is meaningful for development of quantity limits. Nonetheless, in considering the evidence of NUREG/CR-5814 2 , it would appear that NRC's use of the sewage-consumption assumption has been largely successful as a regulatory measure. NUREG/CR-5814 modeled possible doses arising from various pathways and exposure scenarios after waste had been discharged into sewers. For example, the report considered exposures to sewer workers, exposures to persons using sewage sludge, etc. Among other things, this report examined the doses that might be associated with the six incidents cited in the FRN. In no case did the modeled doses exceed the annual 100 mrem limit in 10 CFR Part 20 for routine release from licensed facilities.

Nonetheless, it may be prudent for NRC to consider whether further analyses could be conducted, with the intent of optimizing the regulatory system. We expect that these controls might principally entail modified quantity limits on disposal of particular radionuclides. For such an optimization effort, given the high unlikelihood of many people consuming untreated sewage directly from a licensee, we are skeptical of its efficacy for this task, particularly for short-lived radionuclides. Realistic doses from disposal of radionuclides into sanitary sewers would be associated with other possible pathways, such as those doses 2

Kennedy, W.E., M.A. Parkhurst, R.L. Aaberg, K.C. Rhoads, R.L. Hill, and J.B. Martin, Evaluation of Exposure Pathways to Man from Disposal of Radioactive Materials Into Sanitary Sewer Systems, NUREG/CR-5814, Pacific Northwest Laboratory for U.S.

Nuclear Regulatory Commission, May 1992.

4 that could occur from handling and use of sewage sludge. For these pathways radioactive decay would be an important consideration.

For this task, then, NRC should focus on the possible doses that might be associated with the possible concentration of nuclides (except for tritium and perhaps a few others) within sewage sludge, and possibly with the possibility of precipication or plating of contamination within sewer lines. 3 We suspect that this should be done in a fairly conservative manner to bound variations in sewage plant designs and operating characteristics, and to cover future improvements in wastewater treatment technology. We suspect that probably only a very few radionuclides would possibly require reduced quantity limits.

NUREG/CR-5814 suggested five radionuclides of most concern based on the prevalence of their use by materials licensees. We also suggest that NRC consider the effect of radioactive decay on possible doses when optimizing the system. Most licensees taking advantage of the sewage disposal provisions probably discharge mainly short-lived radionuclides. It could well be that current quantity limits are overly conservative for these radionuclides.

As part of optimizing the system we would suggest that NRC consider that any discovery of radioactive contamination within sewage pipes or sewage treatment plants will likely result in regulatory concern, even if the possible doses are tiny. This is because when the contamination is discovered, it probably will not immediately be conclusively obvious that a possible threat to public health and safety should be ruled out, because the extent of the contamination will probably not be immediately obvious.

Public health officials would probably want to first obtain an improved understanding of the contamination levels, the radio-nuclides involved, the possible pathways for human exposures, the possible magnitude of human doses, and so forth. These activities would require expenditure of time and money.

Finally, we would not recommend that NRC adopt a dose limit approach to regulating discharge of materials into sewers as a primary regulatory mechanism. It would be inefficient for each of the 23,000 licensees to conduct such an analysis, and inefficient for regulatory agencies to review and approve analyses of impacts from sewage disposal for each licensee.

Among other problems, there are a very large number of sewage treatment plants in the country (the FRN indicates 15,000) having very wide variations in designs and operating characteristics.

Exemotion of patient excreta. There is no question about the benefits arising from the use of radionuclides in the medical 3

The NUREG/CR-5814 analysis in this area was limited.

5 field. Nonetheless, it may be useful for NRC to consider this use under two categories. The first of these categories is the use of radioactive materials in diagnostic applications. This use typically involves small quantities of short-lived isotopes, and excreta from these patients should continue to be exempt. On the other hand, some patients receive therapeutic doses of radionuclides; here, large quantities of radioactive materials are used to treat cancer and other diseases. It may be appropriate for NRC to consider further controls on the release of excreta from patients receiving therapeutic quantities of radionuclides.

Additional issues.

1. As noted above, we suggest that NRC retain the existing form of the requirement -- quantity and concentration limits --

as well as its applicability to all licensees. We also suggest, however, that NRC consider ways to optimize the system, perhaps by alternative quantity limits for particular radionuclides. Beyond this, however, we suggest that NRC:

(a) Monitor the efficacy of the recent changes to 10 CFR Part 20 to help determine whether further refinements in the system are really needed; (b) Consider the option of increased inspection of licensees focusing on this area of the regulations; and (c) Consider whether additional analyses should occur in this area, perhaps as part of license renewal activities, focusing on licensees holding large quantities of radioactive material in a nonsealed form. The intent would be to further ensure that adequate safety provisions and procedures are in place to preclude accidental discharge of large quantities of radioactive material.

2. We suggest that NRC contact the Association of Metropolitan Sewerage Agencies or industry trade groups to obtain additional information about variations and trends in sewage treatment facilities, practices, and regulations.

3. The terms "sewage treatment," sewerage treatment," and "sewer treatment" are used interchangeably, which is incorrect terminology. When referring to a wastewater treatment plant, call it a "sewage treatment plant." When referring to the conduit that conducts the sewage, call it a "sewer." When referring to the wastewater conveyance system and its appurtenances call it "sewerage."

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~ ( sq F f{ °1t4o) Metropolitan Waste Control Commission Mears Park Centre, 230 East Fifth $t ' tKf r '

Jp'J l, Minnesota 55101-1633 June 16, 1994 612 222-8423 The Secretary of the Commission '94 JUN 20 P2 :20 U.S. Nuclear Regulatory Commission Washington, D.C. 20555 Attention: Docketing and Service Branch OFf!C( 01t: er '"-,r- -\'"

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1 Re: February 25, 1994 Federal Register Advance 1Jot 'i c e of Proposed Rulemaking. "Disposal Of Radioactive Material By Release Into Sanitary Sewer Systems"

Dear Secretary of the Commission:

This letter is in response to the advance notice of proposed rulemaking. I have spoken with Dr. George Powers (NRC) recently, he stated that comments may still be submitted.

Dr. Powers also stated that he had received comments from the Association of Metropolitan Sewerage Agencies (AMSA). Although these comments were discussed only briefly, the Metropolitan Waste Control Commi s sion (MWCC) believes that AMSA has raised some valid concerns.

Enclosed are two fact sheets regarding the MWCC and the Industrial Waste Division of the MWCC. These fact sheets should help you understand the scope of our organization.

MWCC comments are as follows:

1. The NRC should consider exposure to collection system workers, in addition to wastewater treatment plant (WWTP) personnel and overall environmental issues.

2. Due to the variability, the NRC should consider the size and methods of treatment utilized by a WWTP, when considering the allowable quantity of radioactive wastes discharged.

3. The NRC should consider whether there are multiple NRC license holders discharging to individual WWTP's. It may suffice to keep track of license holders by community.

4. The NRC should consider all "releases" from WWTP's (not just the normal sludges) such as: screenings, grit, ash, and any other residual material generated at a WWTP.

5. In terms of the type or method of deriving a limit, the most appropriate approach would be to evaluate all scenarios of exposure, and choose the most conservative limit in terms of protecting human health and the environment. As far as determining the actual numerical limits, the MWCC has relied on the NRC to establish minimal federal limits. The MWCC would however, like to have the authority to establish more stringent local limits, if warranted.

Equal Opportunity/Affirmative Action Employer n SEP 2 8 19~

'-4' Acknowladged by card ...--""'-"'"

DOCKETING & ::,ERVICE SEClllQN OFFICE OF THE SECRETAR.'11' OF THE COMMISSION.

Document Statistics ar1< Date 6 / 11 /Cf'i Copies Received _ ___,__ _ __

Add'I Copies Reproduced ..,.Jc--_____

Special Distribution 12..:r: 0 5, P/Jh. ,

L 7  ;

Page 2, U.S. Nuclear Regulatory Commission June 16, 1994

6. Regarding radioactive materials within human waste, the February 25, 1994 Federal Register indicated that the Pacific Northwest Lab study did not address these wastes.

The federal register did not indicate whether these types of wastes had been evaluated before. If the NRC is aware of all types, and amounts, of radioactive materials being used in this manner, then the MWCC (at this time) wi ll rely on the judgement of the NRC to evaluate the fate of these wastes.

The fact that radioactive materials are being used for diagnostic or therapeautic purposes is not reason enough to go without a thorough evaluation.

7. Another issue, not necessarily raised in the federal register, deals with reporting and sampling by NRC license holders. As a condition of holding a NRC license, licensees should take and analyze samples, then report these findings to the NRC. A report should also indicate how much radioactive waste was discharged, based on calculations or logs. This information could then be checked against the monitoring results. This information should be readily available to the respective WWTP operator.

8. There is another issue that may be of interest, and warrants consideration; and that is the possibility that a community's wastewater collection system is not 100%

watertight. In other words, there may be the possibility that a small percentage of the wastewater, flowing through the sewer lines, is going into the ground, before arriving at the WWTP.

The MWCC appreciates having the opportunity to comment on these issues. If the MWCC can be of assistance in the future, or if you have any questions related to these comments, please phone Peter Berglund at (612) 772-7008.

Sincerely,

~#~

Leo H. Hermes, P.E.

Industrial Waste Manager MWCC Industrial Waste Division LHH/PAB enclosures cc: Peter Berglund, MWCC

FACT SHEET CONTACT: Jeff Syme (612) 229-2109 METROPOLITAN WASTE CONTROL COMMISSION

1. The Metropolitan Waste Control Commission was established by the Minnesota Legislature in 1969 to manage wastewater in the Twin Cities metropolitan area, to protect the public health and environment.

The MWCC owns and operates the wastewater treatment system in the metropolitan area and treats approximately 300 million gallons of wastewater every day from 105 area communities. The system includes IO treatment plants and more than 500 miles of interceptor sewers (sewers shared by two or more communities that convey sewage from the communities to MWCC's plants for treatment). MWCC's largest facility, the Metro Plant, treats approximately half of the wastewater generated in Minnesota. The MWCC is also responsible for construction and maintenance within the regional system.

3. The MWCC has about 1,200 employees and an annual operating budget of $152.5 million in 1993. The average household in the metro area generates about 80,000 gallons of wastewater each year and is charged less than $100 annt:ally by the MWCC for treatment.

4. The MWCC has a 20-year Implementation Plan that is updated every two years. The Implementation Plan, describing the agency':; goals, projections and strategies to meet future needs, is approved by the Metropolitan Council, the lonr,;-range planning and coordinating agency for the metropolitan area.

A nine-member Board of Commissioners is responsible for policymaking at the MWCC. The chair is appointed by the governor and eight commissioners are appointed to four-year terms by the Metropolitan Council. Commission meetings, which occur several times each month, are open to the public. Day-to-day operations are administered by the MWCC staff, headed by the chief administrator.

6. To track the effectiveness of its treatment programs, the MWCC conducts 200,000 environmental laboratory tests every year, sampling air quality, raw sewage, groundwater and receiving waters. In 1992, MWCC achieved 99.8 percent compliance with all federal and state water quality regulations.

7. The U.S. Department of Energy presented MWCC with a Special Recognition Award for Energy Innovation for a solids processing/energy recovery system that is saving area residents $4 million annually.

8. Every year, the MWCC receives awards for outstanding plant performance from the Minnesota Pollution Control Agency and the national Association of Metropolitan Sewerage Agencies. In 1991, the U.S.

Environmental Protection Agency presented MWCC its Award of Excellence for Beneficial Use of Sludge for MWCC's NutraLime ash-recycling program. In 1992, MWCC was presented an Award of Excellence from the National Environmental Awards Council, representing 28 leading environmental organizations, also for the NutraLime ash-recycling program.

JDS/sgk 08/01/93 Metropolitan Waste Control Commission Mears Park Centre, 230 East Fifth Street, St. Paul. MN 55101 612 222-8423 0

FACT SHEET

Contact:

Jeff Syme (612) 229-2109 INDUSTRIAL WASTE DIVISION

1. The Industrial Waste Division is a division of the Quality Control Department of the Metropolitan Waste Control Commission (MWCC). This division controls and regulates industrial discharges to the sewer system to ensure compliance with local and federal regulations. The division also responds to sewer related spills and community sewer problems.

2. Division staff issue Industrial Discharge Permits to industrial users of the Metropolitan Disposal System (public sanitary sewers). Currently, more than 800 permits are in effect.

3. Each permittee is required to engage in self-monitoring and report to the Industrial Waste Division on a routine basis. These reports are one means of determining permit compliance with the MWCC Waste Discharge Rules.

4. Another means of determining compliance involves monitoring by the Industrial Waste Division, which uses specialized equipment (automatic samplers, flow meters, pH recorders). The U.S. Environmental Protection Agency (EPA) now requires the MWCC to inspect and monitor significant industrial users at least once per year. The samples obtained are analyzed by the Laboratory Services Division of the Quality Control Department. MWCC's laboratory performs approximately 16,000 analyses per year for the Industrial Waste Division.

5. The Industrial Waste Division also regulates liquid waste haulers (septage pumpers). About 40 liquid waste haulers are permitted to dispose of household septage, commercial and certain industrial wastes in the sewer system.

Another special program regulates discharges ofleachate and contaminated groundwater. More than 140 special permits are in effect for these sources, which often result from remedial actions related to underground tank or pipeline leaks or disposal site cleanups.

6. Another important task of the Industrial Waste Division is responding to spills, accidental discharges and other problems which may adversely affect MWCC facilities or the sewer system. Examples include chemical spills, transportation accidents (tank truck or railcar releases), industrial fires (toxic fire-fighting water can result),

underground tank/pipeline leaks, and various sewer blockage or damage problems. The Industrial Waste Division conducts about 60 such response actions of various types each year.

7. The Industrial Waste Division is actively involved in promoting "pollution prevention" among industrial users.

Pollution prevention involves preventing the generation of waste which then requires disposal. MWCC received an EPA grant for this purpose, and activities include workshops, on-site technical assistance, referrals and interagency coordination.

- over -

Metropolitan Waste Control Commission Mears Park Centre, 230 East Fifth Street, St. Paul. MN 55101 612 222-8423

~ 0 0

8. The Industrial Waste Division also perfonns special community flow measuring projects to verify metered wastewater flows and check unmetered discharge volumes. This helps ensure that communities served by MWCC are accurately billed for treatment costs. MWCC also assists local communities in industrial or commercial wastewater-related discharge problems.

9. The Metropolitan Waste Control Commission is responsible for managing wastewater in the Twin Cities area, to protect the public health and the environment. The MWCC serves 105 communities and treats approximately 300 million gallons of sewage per day. Agency policies are set by a Board of Commissioners who represent geographic precincts within the seven-county metro area.

JDS/sgk 08/18/93

DOCKET NUMBER PAoPosEo RULE Pl :<o

{ .f9 FR t:;1J..1b)

DOCKETED May 26, 1994 The Secretary of the Commission USHRC U. S. Nuclear Regulatory Commission Washington, DC 20555 "94 JUN -9 P3 :45 ATI'N: Docketing and Service Branch OFFICE OF SECRETARY 400 South Gil1 Street DOCKETING & SERV\CE State College, PA 16801 BRANCH Comment on Advanced Notice of Proposed Rulemaking:

Disposal of Radioactive Material by Release into Sanitary Sewer Systems

Dear Sirs:

I have a few quick comments regarding your advanced notice of proposed rulemaking on Disposal of Radioactive Material by Release into Sanitary Sewer Systems. These comments are my own and are not related to my employment.

1. Banning release of radioactive material to sewers would impose a huge fmancial burden on all biological research facilities. If the 2700 gallons ofliquid released last year at my institution had required solidification, I would have had to arrange disposal for 70, 55-gallon drums. At $300 - $600 per cubic foot (which is the anticipated cost for disposal at the Pennsylvania LLRW site), liquid waste disposal would have cost an additional $150,000 to $300,000.

2. Pre-notification of each release of radioactive material to the sewer system would be difficult. During 1993, the Broadscope Licensee with whom I am affiliated, through the Health Physics Office discharged the following materials into the sanitary sewer:

H-3 73. mCi S-35 0.400 mCi C-14 0.750 I-125 0.003 P-32 0.260 Other < 0.010 These discharges occurred almost on a weekly basis. The amount of radioactivity released was similar to releases for the last five years, and I expect this year's disposal activities to be. In addition, the approximately one hundred laboratories on campus regularJy pour dish-washing rinse water down the drain. Notification prior to, or even after, such release would be difficult. An annual notification to the sewage treatment plant (STP) listing the radionuclides and amounts released, along with an estimate of the next year's release, should be sufficient for all purposes. This estimate could be as simple as "Last year's releases were .. . Next year's releases will probably be the same, plus or minus 20%". If notifications were required to be sent in January, operators of sewage treatment plants would be able to add up the amount of radioactive material expected to flow through their facilities in the coming year.

SEP 2 8 1994J

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Copies Received I Add'I Copies Rep-rod_uc_ed-.. .-3__- - - -=-

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3. The Commission should recognize that reconcentration of sewage effluent is possible for some radionuclides in some forms of sewage effluent treatment. Some STPs are using marsh grass as a final purification technique.

Reconcentration of biological materials (hydrogen, carbon, iodine, sulfur, iron) is not likely, but the reconcentration of heavy metals (caesium, strontium, americium) might be a problem in this type of effluent treatment.

4. The flat one-curie disposal limit of "other" radionuclides has always bothered me. I keep picturing the following scenano.

137 Professor Smith at a Type A Broadscope License purchased 2 curie solution of Cs in 1950 to use in an irradiation chamber, but never did. His successor, Professor Jones, now wishes to dispose of this material. No low-level radioactive-waste-disposal facility is in available. His university discharges 5 6 1,000,000 gallons of water a day to the local treatment facility. The discharge limit is 10- uCi/ml { 10 x 3785 ml/gallon x 10-s = 37.8 mCi/day}. Ifhe were to set up a drip system, a discharge of260 mCi per week would not exceed any limits. The caesium could be "dumped" within a month with very little cost or effort. The sewage treatment plant might have a problem.

Remember, this might be Professor Jone's only achievable disposal option for the next eight years. (If this is the only possible disposal option, is it then "as low as reasonably achievable"'?)

14 90 137 A curie of C is very different from a curie of Sr or Cs, and any revision to the regulations should recognize this fact.

5. Different annual limits for different radionuclides would not pose an undue burden of record-keeping for any modem office.

6. Please avoid "dose limit approaches". A simple limit, even if a different for each radionuclide, is much preferable to spending hours trying to verify assumptions about fish consumption and groundwater flow to municipal water supplies, and then having to keep track of different limits.

Thank you for considering these comments.

Sincerely, Eric Boeldt, CHP

DOCKET NUMBER p ., *cJ i>ROPOSED RULE...;,..;;.;.....,,,,L...

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DOCKETED SHRC June 3, 1994

• 94 JUN -9 P 3 :so Secretary of the Commission US Nuclear Regulatory Commission Washington, DC 20555 OFFICE Of SECRETARY DOCKETING & SER "ICE BRANCH Attention: Docketing and Service Branch Gentlemen:

This is in response to the request for comments dn the current policy for disposal of radioactive material by release into sanitary sewerage systems, Following is our position on this issue:

(1) Form of material released: The most recent regulations restrict sewerage disposal materials that are soluble or readily dispersible biological materials. We believe that any prior concerns for concentration of non -

biological readily dispersible material are resolved by the new restriction to biological materials and are unaware of any significant problems with soluble material. We therefore recommend continuation of this allowed release form, (2) Total quantity of material: Although these unchanged limits easily meet the needs of most licensees, it seems appropriate,given the new restriction on form of material released and the new more restrictive release concentrations, to consider relaxation of these limits for large users since reconcentration should be much less of a concern. It may even be practical to eliminate such an upper cap totally, depending only on concentration restriction with the reduced limits now in effect, We have never seen the logic in apprying the same cap to a large ~program with thousands of users as is applied to a small one with only a few users.

(3) Types of limits: The present method of limitation based on an individual being exposed by ingestion of wa er from the sewer outfall seems to be sufficien ly conservative to satisfy all needs, particularly in view of the new lower release concentrations. This is readil controllable

• n the workplace and is easily understood for radionuclide users.

Proper adherence to concentrat ' on limits would appear to negate the need for an upper cap mentioned in item 2 above.

(4) Exemption of Pat

• ent Excreta: Continuation of this important exemption is encouraged as a significant ALARA consideration. Collection and control of patient excreta would result in the deliberate reconcentration of a significant waste stream with the potential for worker exposure, sp ' lls, and emergency issues that have been avoided SEP 281 A kno I ged card *-...-*ll1tNnlmmrn:t1'

.S. NUCU:r,*, r '--~ ..,I.I"\ I ORY COMMISSION DOCKETING & SERVICE SECTION OFFICE OF THE SECRETARY OF THE COMMISSION Document Stattstlc:s stmartt Date lt /'( LI Coples Received _ __ _ _ _ __

WI Copies RAproducGd __ J_

Special Distribution fl,;rn~ (IlJfl.,

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through the judicial use of this exemption. The rapid dispersal of this soluble waste stream of short-lived material seems the most practical approach of the exemption in its current form.

We thank the Commission for the opportunity to comment on this important issue and look forward to commenting on any proposed regulations that are forthcoming.

Yours Truly,

~ \ c,_ (U..- *~ *~ {)°'.:,~f\ I \<_-\ ( ~)

Diane V. Johnson, RT(Nl Nuclear Medicine Dept.

Addison Gilbert Hospital Glau., Ma. 01930 AddisoN CilhERT HospiTAL 298 WAsltiNGTON ST CloucESTER, MA 019}()

Nu c l ear Me dicine Dep t

DOCKET NUMBER p 1..0--.

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<a 150 South Huntington Avenue Boston, Massachusetts 02130

• 94 JUN -8 Pl2 :48 In Reply iOfFrtb OF SECRETARY DOCK ETING & SERVICE Secretary of the Commission BRANCH US Nuclear Regulatory Commission Washington, DC 20555 Attention: Docketing and Service Branch Gentlemen:

This is in response to the request for comments on the current policy for the disposal of radioactive material by release into sanitary sewerage systems. Following is our position on this issue:

Form of material released: The most recent regulations restrict sewerage disposal to materials that are soluble or readily dispersible biological materials. We believe that any prior concerns for concentration of non-biological readily dispersible material are resolved by the new restriction to biological materials and are unaware of any significant problems with soluble material. We therefore recommend continuation of this allowed release form.

Total quantity of material: Although these unchanged limits easily meet the needs of most licensees, it seems appropriate, given the new restriction on form of material re l ease and the new more restrictive release concentrations, to cons i der relaxation of these limits for large users since reconcentration should be much less of a concern. It may even be practica l to eliminate such an upper cap totally, depending only on concentration restriction with the reduced limits now in effect. We have never seen the logic in applying the same cap to a iarge program with thousands of users as is applied to a small one with only a few users.

Types of limits: The present method of limitation based on an individual being exposed by ingestion of water from the sewer outfall seems to be sufficiently conservative to satisfy all needs, particularly in view of the new lower release concentrations. This is readily controllable in the workplace and is easily understood for radionuclide users. Proper adherence to concentration limits would appear to negate the need for an upper cap as mentioned above in total quantity of material.

Exemption of patient excreta: Continuation of this important exemption is encouraged as a significant ALARA consideration.

Ackr.owl dged by card gp_~! 19~

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pies Received ____ , _ _ _ __

Add'I Copies Reproduced _1_ .____,____ _

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Collection and control of patient excreta would result in the deliberate reconcentration of a significant waste stream with the potential for workers exposure, spills, and emergency issues that have been avoided through the judicial use of this exemption.

The rapid dispersal of this soluble waste stream of short-lived material seems the most practical approach to this issue and we strongly recommend the continuation of the exemption in its current form.

We thank the commission for the opportunity to comment on this important issue and look forward to commenting on any proposed regulations that are forthcoming.

Sincerely,

~J Medic

HEALTH PHYSICS ASSOCIATE~dc 1

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BOX 796, RD#I usNRc LENHARTSVILLE, PA 19554 (215)75&4153 (VOICE) OCKET NUMBER (215)756-0042 (FAX) D p '94 JUN -8 Pl2 :48 PROPOSED RULE..:..::...:;.;,,--~ .

(S°IFR q,'16)

Secretary us Nuclear Regulatory Commission Washington, DC 20555 Att: Docketing & Service Branch re: Federal Register Notice, Vol. 59, number 38 February 25, 1994 LJi~pco~l 02 ~cG iuhct~v~ m~ t e ~ ial Ly ~el~ase into sanitary sewer systems.

Gentlemen:

Health Physics Associates, Inc. (Lenhartsville, PA) wishes to offer comments on the referenced advanced notice of proposed rulemaking. We believe this issue is only one of many that the Commission will be faced with following the revision of Part 20.

1. Forms of Material for Disposal - The question should go beyond whether the material is soluble upon discharge to what is the likelihood of the radioactive material remaining soluble within the system and not precipitating out. However, the Commission also has to realize that no matter what it permits, someone will find a way to defeat reasonable safeguards. The Commission has to balance the needs of the public with the needs of licensees.

And while common sense dictates that protection of the public must take precedence, that decision must be based on real data and not on computer modeling using unrealistic "worst case" scenarios. The concept of someone ingesting sewage water at the point of release from a licensee's con~rol is high~y unrealistic.

If new technologies of sewage treatment cause reconcentration, an industry will develop to address that problem and prevent public irradiation above whatever l imit is ultimately set.

2. Total Quantity of Material - In working with licensees who wished to utilize sewer discharge as a method, the limiting factor in most cases is the annual limit.

The limits adopted must refl ect real risk. For example, there is probably no risk to sewage workers from tritium, carbon 14, and other beta emitters since ingestion is improbable and volatilization and inhalation does not appear to be very likely.

In this case, limits should be based on the potential for downstream i ntake by a water treatment plant. In the case of a RADIATION PROTECTION CONSULTANTS

11Jt..,.., ._ !I \JI DOCKETING & bl::HVICt SECTION OFFICE OF THE SECRETARY OF THE COMMISSION Document Statistics ar1< Date __,,6~,...._- ~ - - -

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us Nuclear Regulatory Commission ANPR, FR Vol. 59, number 38, February 25, 1994 Disposal of radioactive material by release 2 into sanitary sewer systems.

soluble discharge of cobalt 57 or 60, perhaps the limits should be based on the potential for precipitation and concentration in the sludge, with subsequent external irradiation of sewage plant workers.

The formulation of sewage discharge limits may become a complicated project that should not be trivialized with a simplistic approach that will eliminate this avenue of disposal for a large number of research facilities. If the Commission takes the easy way out, they may find they will have made a significant contribution to the elimination of R&D efforts in this country. Then t>!here wil 1 our new drugs come from? How *will new industrial applications be developed? What will happen to the economic base of this country as we force R&D off-shore? How will the nuclear reactor discharges be truly ALARA if the replacement power production methods carry a far greater risk to the workers or society? The NRC has to begin looking at the impact its decisions will have in forcing the adoption of more hazardous non-radiological technologies. The Commission has to stop hiding behind the excuse that, "The Atomic Energy Act (AEA) does not include that in our responsibility." If the AEA includes the concept of ALARA, which includes the concept of benefit, cost, and total societal impact, the Commission has to begin including the impact on society from non-radiological technologies in its decision making process.

The question of a licensee providing a 24 hour2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> notice to a sewage treatment plant is meaningless. This will become another instance of added record keeping and cost to licensees that offers no protection or potential dose reduction to the public or the workers at a sewage plant. What will the plant do, send its workers home the next day? Very few, if any, sewage plants have personnel that are familiar with radiological units or concepts.

How will a plant manager assess the difference in risk potential, or even the occurrence of detectable radioactivity between discharges from licensees, hospital in-patients, hospital out-patients, infiltration from NORM in the ground and groundwater, and infiltration of surface water containing fallout. Such notification is another example of a meaningless mandate by government that carries added cost to those regulated, but offers no usable information to government. It will, however, increase costs to both licensees and government, if only due to the added records storage costs for government (including sewage plants).

And all of this without any benefit, whatsoever.

3. Types of Limits - Limits must be based on realistic pathways and include both internal and external exposure as appropriate.

It appears, on the surface, that the internal and external pathways have different populations at risk. For example, it

us Nuclear Regulatory Commission ANPR, FR Vol. 59, number 38, February 25, 1994 Disposal of radioactive material by release 3 into sanitary sewer systems.

does not appear likely that a worker in a sewer plant will be exposed to a pathway including ingestion, but will to a pathway including concentration in sludge with subsequent external exposure. Even if a worker were to swallow a mouthful of sewage, the real risk is from biological pathogens and possibly chemical toxins, rather than a low probability, long term risk of radiation induced cancer or leukemia.

The Commission should set limits for each radionuclide based on whether it poses an internal or external risk. This should be further divided into whether the risk is due to the presence in raw sewage (perhaps those highly volatile forms that ~re also soluble if any exist), raw river water (accumulation and concentrated in aquatic life forms and for such uses as fire fighting in some large cities where personnel could be directly exposed), and by way of water that is withdrawn to be treated and distributed as potable water.

The question of types of limits appears to reinforce the concern that we are dealing with a complicated issue that may not have an easy solution. The Commission should consider the real impact its decisions will have on the regulated industry. Too often the NRC and other regulatory agencies perform inadequate financial impact assessments. Given the long term projections for a poor economy, impractical consideration of the impact on the regulated industry may drive many licensees to discontinue the use of radionuclides in research and either discontinue research or use more hazardous non-radiological methods.

4. Exemption of Patient Excreta - It is not known how the NRC can, in all fairness and logic, apply strict control of in-patient excreta while realizing that there is probably a larger total activity of out-patient excreta that enters the sewage system.

We hope these comments are useful in this early stage of regulatory development.

sincerely, GR~

Anthony LaMastra Certified Health Physicist

1/c)

DOCKETED ~

CHARLES F. JOHNSON PRESIDENT Lawrerie~Memorial Hospital

• 94 JUN -8 PS :15 of Medford DOCKET NUMBER PR 2-0 OFFI CE OF SECRETARY I

PROPOSED RULE DOCKETING & SERVICE (sci FR 11'-1£) BRANCH 170 Governors Avenue June 1, 1994 Medford, Massachusetts 02155 617-396-9250 Secretary of the Commission U.S. Nuclear Regulatory Commission Washington, D.C. 20555 Attention: Docketing and Service Branch Gentlemen:

This is in response to the request for comments on the current policy for disposal of radioactive material by re lease into sanitary sewerage systems. Following is our position on this issue:

1. Form of material released : The most recent regulations restrict sewerage disposal to materials that are soluble or readily dispersible biological materials. We believe that any prior concerns for concentration of non-biological readi ly=

dispersible material are resolved by the new res triction to biological materials and are unaware of any significant p roblems with soluble material. We, therefore, r ecommend continuation of this allowed release form.

2. Total quantity of material: Although these unchange d l i mits easily meet the needs of most licensees, it seems appropr iate, g iven the new restriction on form of material released and the new mor e restrictive release concentrations, to consider r elaxation of these limits for large users since reconcentration restriction with the reduced limits now in effect. We have never see n the logic in applying the same cap to a large program with thousands of users as is applied to a small one with only a few us e r s.

3. Types of limits: The present method of limitation based on an individual being exposed by ingestion of water from the sewer outfall seems to be sufficiently conservative to satisfy all needs, particularly in view of the new lower release concentrations.

This is readily controllable in the workplace and is easily under-stood for radionuclide users. Proper adherence t o concentration limiss would appear to negate the need for an upper cap in item 2 above.

as mentioned SEP 2 8 1994.

Acknowledged by card .....*--*--.....--

AN AFFILIATED TEACHING HOSPITAL OF TUFTS UNIVERSITY SCHOOL OF MEDICINE.

I I

S. NU1,.,L*-' . ..., , , 1 vuMMISSION OOCKETlrK, ~ SERVICE SECTION OFF ICE OF THE SECRETARY OF THE COMMISSION Doct.Jment Statistics ark Date , / J... / 9 t./

tA,pies Received. _ _....:/_ _ _ __

d'I Copies Reproduced "" J_____

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4. Exemption of patient excreta: Continuation of this important exemption is encouraged as a significant ALARA consideration.

Collection and control of patient excreta would result in the deliberate reconcentration of a significant waste stream with the potential for worker exposure, spills and emergency issues that have been avoided through the judicial use of this exemption.

The rapid dispersal of this soluble waste stream of short-lived material seems the most practical approach to this issue and we strongly recommend the continuation of the exemption in its current form.

We thank the commission for the opportunity to comment on this important issue and look forward to commenting on any proposed regulations that are forthcoming.

Sincerely,

~d~ 8. h;_~ 1 '7YJ(!Y, Gwendolyn B. Nichols,M.D.

Chief, Department of Radiology GBN/k

DOCKET NUMBER PR 1. 0 u, PROPOSED RULE _

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• rw Northeast Ohio Region8'Sewer District 3826 Euclid Avenue

• Cleveland, Ohio 44115-2504 SC,F R C,JL/6 216

• 881

• 6600 I -'

FAX: 216

• 881

• 9709

'94 JUN -8 PS :16 Mr. Samuel J. Chilk Secretary of the Connnission U.S. Nuclear Regulatory Commission Washington, D.C. 20555 ATfN: Docketing &Service Branch Re: RIN 3150-AE 90

Dear Secretary Chilk:

The following comments are in response to the advance notice of proposed rulemaking (#RIN 3150-AE90) that was published in the Federal Register on February 25, 1994. Pursuant to that notice, the NRC is soliciting connnents on the need for a rulemak.ing regarding disposal of radionuclides into sanitary sewer systems.

Based on the experience of the Northeast Ohio Regional Sewer District (District") and on the experiences of other publicly owned treatment works (POTWs) located throughout the country, it is obvious that current NRC regulations are not adequate to protect the workers and property at POTWs. Th.ere is clearly a need for a rulemaking regarding sanitary disposal. We are concerned, however, that the published notice indicates a lack of understanding as to the proper approach to the regulation of sanitary disposal.

Contrary to the position taken by the NRC, the cases of contamination at P01Ws documented in the notice, and other cases not mentioned, have not been the result of recently developed technologies in sewage treatment. While certainly the NRC should consider the probability that treatment technology will improve and increase the removal efficiencies of radionuclides, there is substantial evidence that the NRC's current regulatory program is not adequately protecting POTWs utilizing very basic wastewater treatment techniques.

As a second preliminary point, the District believes that the NRC's emphasis on the concept of "reconcentration" as the cause of the problem is misleading. In the case of the contamination of the District's Southerly Wastewater Treatment Plant with C0-60, for example, there SEP 2 8 1994 Ac~nowledged by card.. -

The mission of the Northeast Ohio Regional Sewer District is to enhance public health and welfare through the efficient, cost-effective conveyance and treatment of wastewater. This is accomplished by an organization dedicated to professionalism, fairness and consistency that anticipates and responds to the changing environmental needs of the community.

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Mr. Samuel J. Chilk May 19, 1994 Page 2 appears to have been little if any reconcentration in the sense of removal of soluble C0-60 from solution or even in the sense of aggregating very fine suspended particles into larger particles. It appears that particles of C0-60 were simply removed from the wastestream in the same manner as other solids are removed, primarily through settling. The only "reconcentration" that occurred was in the sense that the volume of material surrounding the Cobalt particles was reduced. The situation encountered by the District at the Southerly Plant is one of "hot spots" located within large volumes of slightly contaminated incinerator ash. The "hot spots" are caused by metallic particles of C0-60 that were unaffected by the plant's treatment processes.

As noted in the supplementary information section of the advanced notice, the NRC has previously amended 10 CFR Part 20 to no longer allow the discharge of dispersable (but non-soluble) materials, unless such materials are biological. If this new regulation is adequately enforced, it may prevent many problems with insoluble materials such as C0-60. The District believes, however, that the current language of 10 CFR Part 20 is inadequate to protect POTWs from all radioactive contamination problems and offers the following comments:

1. Impact on Licensees The advanced notice suggests considerable concern that any further tightening of the restrictions on sanitary disposal would have a negative financial impact on NRC licensees. This concern is presumably in part the result of current high cost and limited availability of low-level waste disposal. The only disposal site for most generators, at Barnwell, South Carolina, is scheduled to close during the summer of 1994. Each state (or compact of states) must then assume responsibility for waste generated within it, and provide for disposal. Most states are many years from opening a low-level waste disposal site. We are concerned that radioactive waste generators, such as the SO-plus facilities in Ohio, will be forced to either store such waste, or seek an alternative disposal method such as the sanitary sewers.

Sanitary disposal will, therefore, appear increasingly more attractive to many licensees. Without proper regulation and enforcement, however, the effect of sanitary disposal can ultimately be the creation of huge quantities of low-level waste. For example, the District now has well over 4,000,000 cubic feet of C0-60 contaminated ash at the Southerly facility.

Further compounding the problems with radioactive contamination at PO'IWs is the NRC's position that the party in possession of radioactive material is fully responsible for remediating the situation and must bear the full cost of such remediation. NRC Chairman Ivan Selin has publicly stated this position would remain unchanged in the case of the District

Mr. Samuel J. Chilk May 19, 1994 Page 3 even if the NRC had absolute proof that the material was illegally discharged by a known licensee. The chairman stated the P0TWs only recourse in that situation would be a legal action against the discharger to recover the remediation cost. Notwithstanding this lack of assistance provided by the NRC to a contaminated P0TW, the NRC has also consistently held the position that the Atomic Energy Act pre-empts any attempt by a P0TW to enforce local discharge regulations regarding radiation that are more restrictive than 10 CFR Part 20.

In view of the fact that the consequences of sanitary disposal fall solely on the P0'IW, the District does not believe that the impact on NRC licensees can or should be a major consideration in revising the sanitary disposal regulations. The effect of current NRC regulations and policies is to create a situation that can easily lead to a small volume of low-level waste contaminating a large volume of material, or an entire P0TW. The NRC then requires the public, not the discharger, to pay for the clean-up. This policy must change.

2. Total Quantity/Types of Limits First, the District is amazed that the NRC would even seek public comment on whether dose limits to protect P0'IW workers should be a factor in calculating discharge limits. The District is extremely concerned with the health and safety of employees and therefore insists that worker protection receive the highest priority. The District is very concerned that the NRC would select any level of radiation exposure above background to which P0TW workers (either at the plant or in the collection system) will be exposed without their consent. The very concept of the NRC developing such a dose criteria for P0TW workers flies in the face of the NRC's policy of ALARA (As Low As Reasonable Achievable). The only apparent reason for exposing P0TW workers to any additional radiation dose is to provide a cheap disposal method to NRC Licensees. The District does not find such an approach to be reasonable unless the applicable dose limit is zero.

Limits that are protective of workers are not, however, adequate to protect property at a P01W. The incidents that have occurred at P01Ws to date have not resulted in any significant exposures to workers. What has occurred is that P01Ws have been prevented from using or disposing of the biosolids (sewage sludge) that are produced in the wastewater treatment process. Any method of calculating licensee discharge limits that does not adequately consider the potential for interfering with biosolids disposal at the receiving P0TW is wholly inadequate and can result in billion dollar clean-ups paid with public funds.

Discharge of pollutants other than radionuclides are regulated by the local P0'IW. These local limits for dischargers to the sanitary sewer are based upon the POTWs' influent loading of each pollutant that will

Mr. Samuel J. Chilk May 19, 1994 Page 4 create neither a violation of the plant's effluent limit nor an interference with the plant's biosolids disposal. Developing such local limits is a complex process that requires a knowledge of the volume of a given pollutant being discharged to the system and a knowledge of the plant's capacity to handle that pollutant. Only with this information can a limit be assigned to each discharger that is protective of the plant.

The same general method must be applied to radionuclides if any sanitary disposal is to be safely permitted. Each radionucl ide should be 1

evaluated seperately taking into account such factors as specific activity, half-life, and solubility. The NRC has only recently begun, though its contractor Pacific Northwest Laboratories, to study the basics of the fate of radionuclides in PO'IWs. In addition to lacking knowledge on radionuclide behavior in a POTW, NRC Region III cannot even identify which of its Cleveland area licensees practice sanitary disposal, and therefore cannot possibly have any idea as to the quantities actually discharged.

Given the NRC's lack of knowledge of the elements required to establish effective limits that would be protective of sewage sludge, a reasonable revision to the limits on sanitary disposal may not be possible at this time. The District therefore requests that a moratorium on sanitary disposal be imposed until such time as the NRC can develop limits that are protective of PO'IWs.

3. Exemption of Patient Excreta Medical sources have been implicated in POTW contamination, as evidenced by the Region III conclusion that a hospital was responsible for the radioactive iodine at an Ohio POTW. The level of radioactivity in this facility's incinerator ash was sufficient to cause the ash to be rejected by a landfill after truck monitors at the landfill detected radioactivity. The District understands that, in certain medical applications, a complete elimination of radioactive discharges would be much more difficult to achieve than in an industrial situation.

Nevertheless, all of the above comments are equally applicable to radionuclides, regardless of the source.

4. NR.C Enforcement Revision of the NRC's sanitary disposal regulations will provide protection against future contamination of P01Ws only if coupled with reforms in the NRC enforcement program. 10 CFR Part 20 currently requires that any licensee that utilizes sanitary disposal must maintain a record of such disposals. This record must be available upon request for review by the NRC. There is no requirement for the licensee to submit any type of discharge report to the NRC.

Mr. Samuel J. Chilk May 19, 1994 Page 5 As a result of this policy, NRC Region III is unable to compile a list of dischargers in the Cleveland area. A P01W, such as the District, is therefore unable to obtain a list of dischargers from the NRC in the event the P01W wishes to implement its own surveillance program.

In a petition for rulemaking (August 2, 1993; 58 FR 54071), the District has requested that licensees be required to provide the receiving POTW with 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> advance notice prior to each sanitary disposal of radioactive material. At a minimum, the NRC should also require that licensees submit such notice to the NRC and submit monthly discharge reports to the appropriate NRC regional office as well as to the receiving POTW. These reports should contain a complete record of all discharges for the month, sample results of concentrations, and total quantities discharged for the month and year.

In addition to requiring self-monitoring and reporting, it is imperative that the NRC establish a system of verification sampling of sanitary disposals. It is the District's understanding that the NRC has never conducted such a program and licensees are therefore aware that there is a near zero chance that sample results recorded in their sanitary disposal log book will be challenged by the NRC. Any program that relies on self-monitoring without verification invites carelessness if not fraud.

Pursuant to the Clean Water Act, the District is the local pretreatment authority through delegated authority under the NPDES Program for all pollutants other than radionuclides. District inspectors routinely place automatic 24 hour2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> composite samplers in the sewer downstream of dischargers to verify compliance with all discharge permit limits. Nothing short of an NRC sampling program of this type will provide reasonable assurance that NRC licensees are complying with the sanitary disposal regulations.

In conclusion, the District considers the regulation of sanitary disposal of radioactive material to be a very important issue. In addition to the case studies presented in the advance notice, the District has reason to believe that contamination has been identified at additional POTWs and probably will be found at others as more POTWs are surveyed for radiation.

There is no evidence that this contamination has presented a significant health or safety problem. The District, however, has experienced a three year nightmare during which a never ending string of regulatory issues and concerns of the public and District employees have been addressed. This nightmare has cost over $1.5 million to date, and can be attributed only to inadequate regulations or ineffective enforcement by the NRC. Due to recent discoveries of additional contamination at the District's Easterly plant, there is no end in

Mr. Samuel J. Chilk May 19, 1994 Page 6 sight. Based on the District's experience and the experience of many other P01Ws, major revisions to 10 CFR Part 20 are long overdue, as are revisions to the NRC enforcement program.

Please contact Tom Lenhart at (216) 881-6600 if you wish to discuss these comments.

Sincerely,

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Erwin J. Odeal Executive Director EJO/TEL/ydm cc: Senator Howard Metzenbaum Congressman Martin Hoke Congressman Louis Stokes Mayor Thomas Longo Mayor Michael White Mayor Louis Bacci Mayor Kathleen Edwards Javier Garza (General Accounting Office)

Karen Schneiderman (AFSCME)

Chris Trepal (Earth Day Coalition)

Ken Kirk (AMSA)

Dave Van Fleet (Ohio Water Environment Association)

Barry Koh William Schatz Thomas Lenhart

ASSOCIATION OF METROPOLITAN SEWERAGE AGENCIES 1000 CONNECTICUT AVENUE, N.W. SUITE 410 WASHING~J?~"'jl~QJJ 6-5302 ~3 (202) 833-AMSA FAX (202) 833-4657 U N l., ~

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_ _ , County Urillecl WasleWater IJIS1rlcts, KS Attached for your consideration are comments from the Association of Lowvllle & Jefferson Cou"t.:'= KY CilyolWiclllla,KS Metropolitan Sewerage Agencies (AMSA) on the Nuclear Regulatory An::,,,:~::'::~": &'/nr:.* ~ Commission' s (NRC's) February 25, 1994 advance notice of proposed

- llepaflrnonl ol Public Work!, MO Musachusen, Water Resources Authority, MA W.....,_ Utl lties,MA Lowe,I Regional Water & rulemaking on Disposal of Radioactive Material by Release Into Sanitary Upper BlackSlOne Water PoHUlion Soulh A-IJIS1rlct,MA Essex Sewfflgo IJIS1rlct, MA Sewer Systems. We appreciate the opportunity to provide comments on NRC' s County ot WayM, Ml Detroit Water & S.W.roge llepanment, Ml advance notice. AMSA believes strongly that early input is crucial to crafting City al Grand Rapids, Ml Kilama.zoo Department of Publk: Utilities, Ml Western Lake Superior Sanitary IJIS1rlct, MN an effective and realistic rulemaking.

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Oepartme,. ol Public Ulll~, OH Urillecl Sewerage Agency al Wastingtoo County, OR 8: of publicly owned treatment works (POTWs) to_ fulfill their environmental objectives while exposing treatment plant workers to unmeasured hazards. For c'2':::g~ those facilities experiencing radioactive material contamination, the current Cltyol Ptoiladel~~*s.=: ~:

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Secretary Chilk May 26, 1994 Page AMSA recognizes that the cases of documented radionuclides contamination problems may be isolated instances, and that it would be inappropriate to develop a national standards based on the experiences of potentially only several POTWs. It is therefore crucial that the Commission identify those facilities which are experiencing radioactive materials contamination or which are found subsequently to be contaminated by radionuclides. For those POTWs with documented contamination problems, the Commission needs to move forward immediately with a definitive plan of action. AMSA recommends that NRC commit to a timeframe for the development of guidance to assist POTWs in calculating site-specific limits for the problem dischargers. AMSA urges NRC to work cooperatively with the Environmental Protection Agency (EPA) in the development of the local limits guidance, as that agency is statutorily responsible for protecting the nation's waters and POTW workers. Additionally, AMSA recommends establishing a task force, which will work in concert with EPA and NRC, to be responsible for studying the issue of sanitary disposal of radioactive materials to better understand the nature and extent of the radioactive contamination problem. This task force should be made up of a multi-disciplinary group of NRC, EPA, POTW, and industrial interests.

AMSA hopes that it.s comments are constructive and will assist NRC in moving aggressively forward on the issues outlined in the Federal Register notice. For your convenience, we have organized our comments according to the Commission's specific requests in the advance notice

[pages 9147-9148]. We have also included an additional section, following the general comments section, which addresses several "POTW-Specific Issues" that are of particular interest to AMSA. Please contact me at (202) 833-4655 if you have any questions or comments concerning this letter or other related issues.

Sincerely, Samuel J. Hadeed Director, Technical Services & Regulatory Affairs Attachment

ASSOCIATION OF METROPOLITAN SEWERAGE AGENCIES COMMENTS ON NRC ADVANCE NOTICE OF PROPOSED RULEMAKING "DISPOSAL OF RADIOACTIVE MATERIAL BY RELEASE INTO SANITARY SEWER SYSTEMS"

GENERAL COMMENT

S The advance notice highlights several documented instances where publicly owned treatment works (POTW s) have detected radioactive materials in their sewer system resulting from discharges licensed by the Nuclear Regulatory Commission (NRC). As the Commission is authorized by statute under 10 CFR Part 20 to regulate the release of radioactive material by licensees into sewer systems, the above referenced case studies point to inadequacies within NRC's existing regulatory program. Where radioactive materials have been detected, it is apparent that NRC's regulatory framework is jeopardizing the POTW's required purpose to protect worker health and safety, as well as environmental quality. The inability to prevent this type of contamination may result in exorbitant clean-up costs unfairly borne by the public.

AMSA urges that the Commission assume a greater role in preventing any further contamination of POTW facilities by radionuclides.

AMSA recognizes that the problem of radionuclides contamination may be isolated to the instances referenced in the advance notice. While it is imperative that NRC protect these facilities with existing radioactive material contamination problems from further difficulties, it would be a mistake to subject POTWs to a national regulatory program based on several specific cases. AMSA strongly recommends that the Commission undertake a study, in conjunction with EPA, to determine the extent of this problem nationally. The Commission needs to determine the specific magnitude (by mass of pollutant and flow rate), character (types of pollutants), and geographic location (by POTW service area) of material discharges to the nation's sewer systems. This study will allow NRC to identify which facilities are discharging specific types of materials and which additional POTWs, if any, are impacted.

The Commission admittedly has not developed a sufficient understanding of the fate, transport, and impact of radioactive materials discharges through the sewer systems.

Before NRC can improve upon its current program, the Commission needs to better understand the nature of radioactive releases and the ability of treatment works to handle different types and quantities of radionuclides. AMSA strongly recommends that NRC, in conjunction with the U.S. Environmental Protection Agency (EPA), selected POTWs, and affected industries, initiate a data collection and survey effort to assess the exposure and contamination pathways of radionuclides. A collaborative effort offers

the best chance to understand the nature of the problem from its source. This study will provide a framework to apprise POTW s of the impacts of different types of radionuclides as they are transported throughout the sewer system and different types of wastewater treatment plants.

The Association believes that the POTW local limits development process is the appropriate mechanism for assuring the protection of environmental quality and worker health and safety. However, NRC should develop specific guidance for use by POTWs in calculating and allocating local limits for radioactive material discharges, as POTW s likely have limited experiences with the regulation of radioactive materials. The information from the study should be utilized to develop guidance for the calculation of site-specific limits (i.e., local limits) at impacted sewer systems. If a system has been contaminated, or if the POTW finds necessary to prevent potential future contamination, the POTW would employ the guidance to establish limits for dischargers of radioactive materials of concern.

At a minimum, the guidance should address the following considerations:

• number of facilities discharging radionuclides to the POTW, or contribution of radionuclides from multiple discharges;

• effects of half-lives, solubility, and specific activity of different radionuclides;

• type and mass of different radionuclide pollutants;

• impacts on biosolids handling and disposal methods;

• different routes of exposure, such as ingestion and inhalation, and other worker health and safety considerations; and

• flow rate into the POTW.

The possession of the necessary legal authority to establish local limits for discharges of radionuclides from NRC licensees is of equal importance to the POTW as part of the issuance of appropriate local limits guidance. The Commission needs to recommend that POTW s be authorized to establish local limits for radionuclides where the treatment plant deems it necessary to protect human health and the environment.

AMSA Comments on NRC Advance Notice Page 2

PUBLICLY OWNED TREATMENT WORKS - SPECIFIC COMMENTS ISSUE: Whether NRC should consider the prevention of biosolids use and disposal interference in establishing site-specific limits AMSA members believe that interference with biosolids use and disposal must be a consideration for POTW s in establishing local limits for facilities discharging to the sewer system. While current limits appear to restrict the exposure to radionuclides in liquid waste, case studies in the advance notice show that the current limits on radionuclides disposal are not adequately protecting biosolids from contamination.

POTW s that have industries located in their service area, which discharge high levels of radionuclides over a short period of time, may also be inadequately protected.

POTWs must use and dispose of biosolids in a safe and legal manner, and the amount of radionuclides discharged to the sewer system must not interfere with this process.

If restrictions are ultimately placed on the use or disposal of biosolids due to contamination with radioactive materials, the Commission, in conjunction with EPA, must develop guidance to assist POTW experiencing such problems in establishing site-specific discharge limits that protect beneficial use programs.

ISSUE: How NRC can calculate the maximum load of radionuclides that may be discharged to a particular POTW AMSA believes that, given the experience of several POTW s with documented radionuclides contamination, current limitations on radionuclides disposal do not properly reflect the hazards involved in discharging radioactive materials through the sewer system.

The Commission will need data to support the development of local limits guidance for POTW s. NRC acknowledges that it does not have a sufficient understanding of the issues regarding the potential for interference, pass through, and reconcentration of radionuclides in particular wastewater treatment systems. An understanding of these issues is absolutely necessary to crafting appropriate guidance for POTW s to use in developing supportable site-specific limits that are sufficiently protective of the particular facility. AMSA strongly recommends that NRC, in cooperation with EPA, POTWs, and industry, conduct further testing and surveys on the radiation issue to enable the Commission to develop such guidance.

The Commission should fund and initiate a phased study to determine the fate of radionuclide discharges to the sanitary sewers and to identify those facilities currently experiencing radionuclide contamination. An appropriate study would include: (1)

AMSA Comments on NRC Advance Notice Page 3

POTW hazard identification; (2) exposure assessment; (3) toxicity assessment; and (4) risk characterization. The study should have two concurrent objectives. First, the study should establish a database to determine the specific magnitude (by mass of pollutant and flow rate), character (types of pollutants), and geographic location (by POTW service area) of radioactive material discharges to the nation's sewer systems. This data would allow the Commission to identify which facilities are discharging specific types of radioactive materials and which POTWs are impacted. Second, the study should investigate the impacted POTWs and the fate of the various radionuclides as they enter the plant's influent and residuals management processes, and as they are discharged from the treatment system. The costs of data collection, data reporting, and worker training should be borne by NRC license holders.

Once such a study has been completed, the Commission should proceed with the development of local limits development guidance for use by POTW s. AMSA recommends that the considerations, referenced earlier, be addressed in such guidance At the municipal level, POTWs restrict the amount of regulated pollutants discharged to their system through implementation of the pretreatment program and development of local limits for individual industrial user discharges. Local limits define the level of pollutants that, upon being introduced to the treatment plant's influent, will not lead to occurrences of interference or pass through. Developing such local limits is a complex process that requires knowledge of the volume and mass of a given pollutant being discharged to the system and an understanding of the plant's capacity to handle that pollutant. Only with this information can a limit that is protective of the plant be assigned to each discharger. AMSA believes that the same general method should be applied to the disposal of radionuclides in those specific sewer systems with existing contamination problems. AMSA urges NRC to develop generic guidance for use by POTW s in developing local limits for radioactive material discharges, where appropriate, to protect the treatment plant workers and processes.

Additionally, NRC should be aware of two EPA resources that are used to develop and implement local discharge limits. The computer program PRELIM is employed by EPA as a means to calculate local limits for pollutants that enter POTWs. EPA also has a publication that may provide appropriate guidance, entitled Guidance Manual on the Development and Implementation of Local Limits Under the Pretreatment Program (EPA, 1987). The Commission should consult with these EPA resources as it develops local limits guidance.

AMSA Comments on NRC Advance Notice Page 4

ISSUE: What provisions NRC might include in its regulations to adequately protect POTWs from radionuclide contamination As mentioned previously, the local limits program offers a proven approach towards protecting worker health and safety and preventing biosolids contamination. Currently, however, NRC acknowledges that it does not have enough technical information on the amount of radionuclides discharged to the sewers or on the fate and transport of radioactive material through different types of POTW processes. AMSA recommends that NRC, in cooperation with EPA, be required to conduct a survey of licensee discharges to POTWs.

As a preliminary measure of protection, prior to the development of actual site-specific discharge limits, NRC should provide a means for POTWs experiencing contamination from radionuclides to be informed of all permitted radionuclide discharges within a sewer service area. AMSA endorses the Northeast Ohio Regional Sewer District's (NEORSD's) request for an amendment to NRC's program requiring NRC licensees to provide at least 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> advance notice to the appropriate POTW before releasing radioactive material to the sewer system. This notification will give the POTW operation sufficient time to consider the implications for worker health and safety and for biosolids use and disposal of specific discharges. At a minimum, the Commission should also require that licensees submit such notice to the Commission and submit monthly discharge reports to the appropriate NRC regional office as well as to the receiving POTW. These reports should contain a complete record of all discharges for the month, sample results of concentrations, and total quantities discharged for the month and year. Similarly, all permits issued to licensees by NRC should include a requirement for advance notification by the permitted discharger to the POTW.

FORM OF MATERIAL FOR DISPOSAL - SPECIFIC COMMENTS ISSUE: How the potential regulations should take into account the technologies for processing sewage, including bioprocessing or exchange [page 914 7]

The Commission should be required to take into account the different technologies for processing sewage, including biosolids processing, in conducting the research into the implications of introducing radioactive materials to POTW s and in developing site-specific limits to protect to POTWs from harmful levels of radionuclides. NRC should address each of the different types of basic wastewater treatment technologies. AMSA AMSA Comments on NRC Advance Notice Page 5

suggests that NRC, in consultation with EPA, develop a table listing each type of treatment technology, accompanied with recommendations on the amount of each type of radionuclide that the particular process can handle. This information will assist POTW operators when developing local limits for dischargers of radionuclides.

ISSUE: What are the potential impacts upon licensed users of radioactive materials which discharge to POTWs from further restrictions regarding the forms of materials suitable for disposal [page 914 7]

The Commission has initiated studies to analyze typical wastewater treatment processes, including a determination of how the solubility of materials in treatment plant influent may be changed in a way that affects the potential dose to members of the public. In those instances where contamination at a POTW has been documented, AMSA believes that licensees must recognize that safety of the community overrides the desire for a licensee to use its current disposal option. However, in order for these POTWs to fulfill their requirements under their National Pollutant Discharge Elimination System (NPDES) permit, in relation to safeguarding worker health and safety and providing safe use and disposal options for biosolids, dischargers of radionuclides must conform to the limits or restrictions imposed on them through future pretreatment permits and sewer use ordinance provisions.

TOTAL QUANTITY OF MATERIAL - SPECIFIC COMMENTS ISSUE: How should a total quantity limit for radioactive materials discharges be expressed [page 914 7]

Again, AMSA believes that the most effective approach to address radionuclide contamination is to develop appropriate guidance for POTWs to protect themselves from contamination. If a POTW finds that it is necessary to protect environmental quality and worker health and safety from contamination, it is appropriate for that facility to use a total quantity limit for radionuclides dischargers. AMSA recommends that NRC express this limit as the amount of material discharged per year (mrem/year) or per day (mg/day). AMSA believes that narrative limits may be open to too broad an interpretation to be applied effectively. However, narrative limits are acceptable if they specifically authorize the POTW to develop its own limits whenever appropriate to better safeguard worker health and safety and environmental quality.

AMSA Comments on NRC Advance Notice Page 6

ISSUE: What approach could be used to limit the total quantity of ,!Och radionuclide [page 91471 AMSA recommends that NRC develop specific guidance for use by POTWs in calculating and allocating local limits for radioactive material discharges, as POTW s likely have limited experiences with the regulation of radioactive materials. If a system has been contaminated, or if the POTW deems it necessary to prevent potential future contamination, the POTW would employ the guidance to establish limits for dischargers of radioactive materials of concern. This guidance should address the considerations outlined on page 2 of these comments.

ISSUE: What are the potential impacts on licensee's operations associated with further restrictions on the total quantity of radioactive material which could be released during a year [page 9148]

AMSA believes that an unavoidable result of further restrictions will be an increase in operational costs to the licensee. If a discharger's release exceeds the allowable quantity of radioactive material, the licensee will need to find alternative methods of disposal which will likely impose a greater cost. Another unavoidable result of further restrictions is an increase in the amount of paperwork for the licensee associated with more monitoring and reporting requirements. This paperwork increase is necessary to serve as proper notice to the POTW of any radioactive materials discharges. In view of the fact that the consequences of sanitary disposal of radioactive materials fall solely on the POTW, the NRC regulations could potentially lead to a low-level waste contamination of a large volume of material, or an entire POTW. By the present system, the public pays for the ultimate cleanup of contaminated sites and the POTW is held to blame. This philosophy must be changed to hold the dischargers more responsible for the pollutants they are introducing, regardless of potential impacts.

AMSA Comments on NRC Advance Notice Page 7 fi6-C -9 vswv:,1.g l N3s

ISSUE: Whether the total quantity of radionuclides that may be released to a sanitary sewer by a licensed nuclear facility should take into consideration the capacity and treatment methods used by the wastewater treatment plant that serves the licensee; whether consideration should be given to the fact that many licensed facilities may discharge into the same sewer treatment plant AMSA agrees that, in establishing total quantity limits for releases of radioactive materials at those facilities with current contamination problems, consideration should be made of the capacity and treatment methods (including biosolids processing and use) and the number of nuclear facilities discharging to the POTW.

TYPES OF LIMITS - SPECIFIC COMMENTS ISSUE: Whether the Commission should continue an approach of limitation based upon an individual being exposed by the ingestion of water from the sewer outfall; Whether the Commission should consider other locations, such as at a treatment facility, in determining the level of protection to be provided [page 9148]

AMSA believes that appropriate local limits for the prevention against radionuclides contamination should address the following considerations: elimination of harmful exposure at the treatment plant, and immediately downstream from the facility; and safeguarding of the safe use and disposal of biosolids. AMSA notes that limitations should be based on an individual being exposed to radionuclides at the influent of the POTW, thereby achieving the joint result of maximizing worker health and safety protection while also eliminating potential hazards to the POTWs processes.

Additionally, the Association believes that since the POTW worker could theoretically be exposed to radiation 365 days per year, the maximum daily allowable discharge from each facility should not exceed 11365th of the annual human exposure limit.

Issue: Whether limits should be based on a dose limit approach accompanied by total quantity and concentration values in a Regulatory Guide to facilitate compliance with the dose limit [page 9148]

AMSA supports the use of dose limits as the most reasonable way to regulate the licensee's discharge. However, the Association is concerned with the implication of selecting any level of radiation exposure above background to which POTW workers AMSA Comments on NRC Advance Notice Page 8

(either at the plant or in the collection system) will be exposed without their consent.

The provision of a simple, cost-effective disposal method for radioactive materials is not an adequate reason to expose POTW workers to radiation. AMSA believes that the dose limit for POTW workers should not exceed background levels.

Additionally, the publication of a regulatory guide to facilitate compliance would be helpful to give each discharger the same level of information prior to discharge.

EXEMPTION OF PATIENT EXCRETA - SPECIFIC COMMENTS ISSUE: Whether it is appropriate to continue the exemption for patient excreta AMSA believes that the exemption for patient excreta should be continued.

AMSA Comments on NRC Advance Notice Page 9

OOCKETEO WHIDDEN MEMORIAL HOSPITAL USHRC tn ~<,'t1r/tl)u/ Sin'<'!

• 94 JUN -7 A9 :47 !1erel/ . .\/.1 U.ll1'J ',I)()';

11,, -).;1,<) - (,.J-1) f,1x 11,rJ ;st -1.1s OFFICE OF S CRETARY wMay 25, 1994 DOCKETING & SERVICE BRANCH DOCKET NUMBER PROPOSED RULE R

p 20

(~'7F~ q/Lfb)

Secretary of the Commission US Nuclear Regulatory Commission Washington, DC 20555 ATTENTION: Docketing and Service Branch Gentlemen:

This is in response to the request for comments on the current policy for disposal of radioactive material by release into sanitary sewerage systems. Following is our position on this issue:

(1) Form of material released: The most recent regulations restrict sewerage disposal to materials that are soluble or readily dispersible biological materials. We believe that any prior concerns for concentration of non-biological readily dispersible material are resolved by the new restriction to biological materials and are unaware of any significant problems with soluble material. We, therefore, recommend continuation of this allowed release form.

(2) Total quantity of material: Although these unchanged limits easily meet the needs of most licensees, it seems appropriate, given the new restriction on form of material released and the new more restrictive release concentrations, to consider relaxation of these limits for large users since reconcentration should be much less of a concern. It may even be practical to eliminate such an upper cap totally, depending only on concentration restriction with the reduced limits now in effect.

We have never seen the logic in applying the same cap to a large program with thousands of users as is applied to a small one with only a few users.

(3) Types of limits: The present method of limitation based on an individual being exposed by ingestion of water from the sewer outfall seems to be sufficiently conservative to satisfy all needs, particularly in view of the new lower release SEP 2 8 1994 ~

Ac"now1edged by card .................,_...__ _

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concentrations. This is readily controllable in the workplace and is easily understood for radionuclide users. Proper adherence to concentration limits would appear to negate the need for an upper cap as mentioned in item 2 above.

(4) Exemption of Patient Excreta: Continuation of this important exemption is encouraged as a significant ALARA consideration. Collection and control of patient excreta would result in the deliberate reconcentration of a significant waste stream with the potential for worker exposure, spills and emergency issues that have been avoided through the judicial use of this exemption. The rapid dispersal of this soluble waste stream of short-lived material seems the most practical approach to this issue and we strongly recommend the continuation of the exemption in its current form.

We thank the commission for the opportunity to comment on this important issue and look forward to commenting on any proposed regulations that are forthcoming.

Yours truly, Ross T. France Thomas Arana, M.D.

Chief Executive Officer Radiation Safety Officer

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{sq FRq1'ftj DOCKETED USNRC May 24, 1994 *94 JUN -7 A9 :45 OFFICE OF SECRETARY DOCKETING & SERVICE BRANCH The Secretary of the Commission Attention: Docketing and Service Branch U.S. Nuclear Regulatory Commission Cushing Campus 235 N. Pearl Street Washington, DC 20555 A-ockton. MA 0240 l

.8.427 .3000 RE: 10 CFR Part 20, RIN 3150-AE90, DISPOSAL OF RADIOACTIVE MATERIAL BY RELEASE INTO SANITARY SEWER SYSTEMS

Dear Sir/Madam:

As a Physician and a Registered Technologist in Nuclear Medicine we are involved with diagnostic and therapeutic Nuclear Medicine procedures. I feel that patient excreta should be exempt from any prohibitions on disposal into the sewer system. Lack of disposal of excreta into the sewer system would cause serious disruptions of critical diagnostic and therapeutic services and result in more contamination and exposure to the public at large. The only practical solution is to allow excretion into the sewer system as is the current practice.

Sincerely, s~~

Robert A. Nebesar, M.D. ~  : : Reilly, CNMT Radiologist Lead Technologist Nuclear Medicine Dept.

A SJM>nsorcd .\ffiliatc of Cmitas Christi .

.\ Catholic Healthcare System. ,md An .\ffiliate j ei of Goddard I lc,~th l'lruu1in~ ( ~orporati

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DEPARTMENT OF HEALTH&. HUMAN SERVICES Public Health Service DOCKETED National Institutes of Health Bethesda, Maryland 20892 "94 JUN -6 P2 :59 OFFICE OF , CPET~ qy The Secretary of the Com.mission OOCKE Tll'G 0
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U.S. Nuclear Regulatory Commission B *.. :r:r J.t4 2 1994 Washington, DC 20555 Attn: Docketing and Service Branch DOCKET NUMBER PROPOSED RULE PR .2..0 (~~FR qu..;,&J

Dear Sir,

The National Institutes of Health (NIH) wishes to provide the following comments regarding the Advanced Notice of Proposed Rulemaking for "Disposal of Radioactive Material by Release into Sanitary Sewer Systems", published in the Federal Register on February 25, 1994. NIH is a large facility conducting biomedical research and medical diagnosis and treatment. Disposal of radioactive materials to the sewer is performed in accordance with existing regulations and conditions of our license with the NRC. Radioactive materials are utilized in laboratory research, which generates a large quantity of aqueous radioactive waste, and in research with patients, which generates a large volume of radioactive excreta. TABLE 1 is a list of radioactive materials received at NIH from 1989-1993.

Radionuclide usage fluctuates considerably for some isotopes. New research procedures may result in large increases or decreases in the use of certain radionuclides. Yet in spite of this, NIH has been able to successfully manage the radioactive liquid wastes in accordance with existing regulations and license conditions. Any changes to the regulations that would place new restrictions or further limit this method of disposal would have a significant negative impact on NIH's radioactive waste management program and the programs of other similar research facilities.

Existing license conditions and procedures at NIH require collection of all radioactive liquid wastes from laboratories for analysis and disposal at a centralized waste management facility. Once centrally collected, radioactive liquids may be discharged to the sewer system or placed in any one of nine holding tanks (total storage volume approximately 76,000 liters) prior to discharge. The primary use of the tanks is to hold short-lived radionuclides for decay, thus minimizing the radioactivity discharged. NIH has been granted an exception to the regulations governing the total quantity of materials that may be discharged. The exception allows a total annual release limit of 296 GBq (8 Ci) for all radionuclides. This exception has been extremely beneficial in allowing NIH to successfully manage the radioactive liquid wastes generated. For example, NIH utilizes a large quantity of S-35 in conducting biomedical research (see TABLE 1). The annual quantity of S-35 alone discharged to the sewer has consistently been above 37 GBq (I Ci) each of the past five years. Discharge of this. level of radioactive materials to the sewer would not be possible if the special exception were not authorized. However, the amount of H-3 discharged is well below the 185 GBq (5 Ci) limit in the regulations (see TABLE 4). It is important to note that all discharges from NIH have been below 1 % of the maximum permissible concentrations (IO CFR 20, Appendix B, Table 1, Column 2) when annually averaged for the past 5 years.

It would be beneficial to further study the issue of reconcentration of radioactive materials at sewer treatment plants (STP's). It appears, from the case studies presented in the February 25, 1994 notice, that the primary radionuclides of interest are radioactive metals or wastes that were not soluble, not the majority of radionuclides typically used in biomedical research facilities such as NIH. A determination on whether or not to further restrict the total quantity of radioactive materials released should be based on a thorough study of the treatment technologies used and radiological impact to the public that results from reconcentration of radioactive materials at the STP's or use of the STP residue in some other fashion. It may be determined that the existing limits in IO CFR 20.2003 are overly restrictive for some radionuclides and not restrictive enough for others. Adjustments could be made that would eliminate the need for special licensing approval for exceptions to the regulations, such as the one NIH has been granted, and allow greater flexibility to licensees whose use of radioactive materials changes over time.

SEP 2 s* 19941 Ac! no *I dged by card ...... ..... -

Reduction in the amount of radioactive material that may be released to the sewer may present a significant financial burden to large research facilities such as NIH. It may be necessary to solidify liquid wastes for land disposal, acquire additional storage facilities such as tanks, or identify other waste treatment systems to remove the radioactivity from the liquid waste stream. For example, solidification of liquid wastes would be tremendously expensive given the current cost of disposal of solid radioactive wastes. In 1993 NIH generated 140,299 liters of aqueous liquid radioactive waste. Solidification of this volume of liquid would generate approximately 1350 55-gallon drums of solid waste. At the current cost for disposal at Barnwell, SC for out of region waste, this would represent approximately $2. 8 million. It would also increase the potential for spills involving radioactive liquids and higher radiation doses to the waste technicians due to increased handling of the liquid waste.

Radioactive excreta from patients is not collected and managed as other radioactive wastes at NIH. NIH has a 450 bed research hospital and admits a large number of patients for diagnostic and therapeutic procedures each year; The majority of patients admitted at NIH for research studies receive radiopharmaceutical doses below 1.11 GBq (30 mCi) and are released with no radiation safety restrictions pursuant to 10 CFR 35.75. Some of these patients may remain in the hospital for observation with no further radiation safety restrictions on their activities. A small number of patients are administered doses greater than Lll GBq (30 mCi) for therapeutic treatment, primarily thyroid cancer treatment using 1-131. While these patients remain under radiation safety restrictions until released pursuant to 10 CFR 35. 75, no excreta is collected and managed as radioactive waste. Collection of all the excreta as radioactive waste would present a substantially increased radiation hazard to NIH employees due to the large activity administered to the patients, typically 5.55-11.1 GBq (150-300 mCi). The current method of disposal is appropriate for maintaining radiation doses to patients, nurses, and waste handling personnel ALARA.

Another consideration in deciding the appropriateness for continuing the exemption for patient excreta is the fact that the majority of the radionuclides used in human research studies have very short half-lives, typically less than 9 days. Data from May 1993 through April 1994 shows that 4,365 radiopharmaceutical doses were prepared for patient studies at NIH (see TABLE 2). Excluding Xe-133 studies (which generate no solid or liquid waste) and Sr-89 therapies, the remaining 4240 doses were of radionuclides with half lives less than 9 days. These studies accounted for 96.8% of the radioactivity. Studies utilizing Tc-99m, the shortest lived radionuclide with a half-life of approximately 6 hours6.944444e-5 days <br />0.00167 hours <br />9.920635e-6 weeks <br />2.283e-6 months <br />, accounted for 87.7% of the total radioactivity used during this period (see TABLE 3).

If these radionuclides were found to accumulate in sludge or other water treatment facility residues, the radiological impact would be negligible due to rapid decay of the radioactivity.

Removal of the patient exemption would present significant problems in conducting a biomedical research and medical diagnosis and treatment program. Questions arise such as: "Would this result in changes to 10 CFR

35. 75?", "Would a patient that receives fil!Y radiopharmaceutical dose have their activities restricted for radioactive waste management purposes?", "Is there a significant difference in patient excretion at a licensed 'facility as*

compared to excretion at a person's home or other public location?", "How will the licensee calculate the total radioactivity released by each patient and must this information be maintained in facility records?", and "Will this result in less effective medical diagnosis and treatment if use of smaller quantities of radioactive materials is required to comply with restrictive sewer discharge limits?" If the exemption for patient excreta is removed, a significant volume of radioactive waste will result. Assuming each dose, excluding Xe-133 doses, from TABLE 2 was administered to one patient and waste. from each patient is collected for a minimum of one day, using the average values of approximately 1000 ml/day of urine excretion and 135 gram/day fecal loss (ICRP 26, October 1974), the minimum amount of additional radioactive waste that would have to be collected annually is 4244 liters of urine and 55,172 grams (over 0.6 tons) of feces.

The NRC will need to consider the impact on all patient care activities if the current exemption is removed from the regulations. It is recommended that the current exemption for patient excreta be continued without further restriction.

Another topic for the NRC to consider is the disposal of radioactive animal excreta. Use of radioactive materials in animals in biomedical research studies is ongoing. Collection and disposal of animal excreta is increasingly difficult due to restrictions placed on waste generators by commercial waste processors and disposal facilities. It is common that "biological" wastes, including animal excreta, are not accepted at waste processing and disposal

facilities unless they are first treated. It is logical that disposal of animal excreta to the sewer should be considered exempt as the current disposal of patients excreta is. There is no significant difference in the waste forms other than the fact that studies involving animals may use longer-lived radionuclides such as H-3, C-14, and I-125. This will ease the burden of research facilities that use a large number of animals in biomedical research.

We hope that these comments are useful for your review of this topic. Please feel free to contact me at (301) 496-2254 if you have any questions regarding these comments.

TABLE 1 NIH - Total Annual Radioisotope Receipts, by year - GBq (Ci).

Isotope 1989 1990 1991 1992 1993 H-3 786.1 (21.245) 1207 .5 (32.636) 477.6 (12.908) 451.4 (12.199) 478.3 (12.928)

C-14 9.5 (0.256) 9.9 (0.267) 10.5 (0.285) 8.2 (0.221) 8.6 (0.232)

S-35 653.6 (17,664) 708.3 (19.143) 619.1 (16.733) 663.0 (17.920) 597.2 (16.141)

P-32 799.3 (21.604) 866. 7 (23.425) 892.4 (24.118) 961.0 (25.974) 899.0 (24,297) 1-125 239.2 (6.466) 244.9 (6,620) 205.1 (5,543) 176.5 (4,771) 157 .9 (4,268) 1-131 453.0 (12.242) 375.7 (10.155) 291.4 (7,875) 341.0 (9,216) 217 .0 (5,864)

Ga-67 72.4 (1,958) 68.0 (1,838) 77.2 (2,086) 54.8 (1.481) 67.3 (1,819)

Tc-99m 533.8 (14,426) 501. 7 (13.560) 594.4 (16.066) 752.5 (20.339) 643.0 (17.378)

Ca-45 7.4 (0.201) 5.5 (0.149) 5.1 (0.138) 3.8 (0.104) 4.8 (0.129)

Cr-51 226.6 (6.123) 249.5 (6,742) 221.4 (5,983) 186.2 (5,033) 162.2 (4,383) ln-111 17 .9 (0.483) 18.8 (0.507) 26.3 (0. 712) 26.2 (0. 708) 19.9 (0.537)

Lu-177 0.1 (0.002) 0.0 (0.0) 0.6 (0.017) 87 .0 (2,350) 7.0 (0.189)

Tl-201 48.0 (1.296) 58.9 (1,593) 75.9 (2,051) 90.5 (2,445) 110.4 (2.985)

Cu-67 11.8 (0.319) 12.0 (0.323) 6.4 (0.172) 1.8 (0.049) 3.0 (0.082)

Y-90 109.3 (2,953) 1 53. 1 (4.139) 118.0 (3.190) 59.9 (1,620) 43.3 (1.170)

Mo-99 12767.6 (345.07) 12736.9 (344.24) 12987. 7 (351 .02) 12549. 7 (339.18) 12195.9 (329.62)

Other 327.0 (8,837) 413.1 (11.165) 407.8 (11.021) 274.4 (7 .416) 273.8 (7.401)

Total 17062.3 (461.144) 17630.6 (476.502) 17017.0 (459.918) 16687.9 (451.023) 15888.65 (429.423)

TABLE 2 Radiopharmaceutical Doses Prepared - May 1 993-April 1 994 I STUDY DOSES TOTAL ACTIVITY I I I GBq (Ci)

Adrenal MIBG 1-131 12 0.2 (0.006)

Bone Tc-99m 1,688 1,561.4 (42.200)

Brain Tc-99m 8 3.0 (0.080)

Cisternagram ln-111 2 0.04 (0.001)

Gallium Absess/Tumor Ga-67 158 56.8 (1 .535)

Venogram Tc-99m 1 0.9 (0.025)

Gastric Emptying Tc-99m/ln-111 13 0.3 (0.008)

GI Bleed Tc-99m 16 14.8 (0.400)

Heart(TcO 4 /PYP) Tc-99m 1,189 1,099.8 (29. 725)

Heart (Sestamibi)Tc-99m 35 67.0 (1.810)

Heart Tl-201 491 72.7 (1.964)

Hepatobiliary Tc-99m 15 2.9 (0.078)

Liver/Spleen Tc-99m 22 4.9 (0.132)

Lung V iO Xe-1 33 121 103.6 (2.800)

Lung MAA Tc-99m 118 17.5 (0.472)

Meckle's Tc-99m 3 1.1 (0.030)

Parotid Tc-99m 1 0.3 (0.007)

Parathyroid(TcO 4 ) Tc-99m 57 42.2 (1.140)

Parathyriod Tl-201 4 0.4 (0.012)

Renogram Tc-99m 31 1.1 (0.031)

Renogram 1-131 51 0.3 (0.007)

Renogram MAG3 Tc-99m 37 13. 7 (0.370)

Thyroid Uptake 1-1 23 96 0.7 (0.018)

Whole Body 1-131 73 13.5 (0.365)

Therapy 1-131 20 149.9 (4.050)

Limb perfusion 1-131 66 0.5 (0.0145)

Renal (DMSA) Tc-99m 4 0.4 (0.012)

Lymphoscintigraphy Tc-99m 16 0.6 (0.016)

Breast (Sestamibi) Tc-99m 13 9.6 (0.260)

Therapy Sr-89 4 0.6 (0.016)

Totals 4,365 3,240.6 (87 .585)

TABLE 3 Radiopharmaceutical Doses BREAKDOWN BY ISOTOPE ISOTOPE DOSES ACTIVITY GBq (Ci)

Tc-99m 3263 2841 .6 (76.800)

Tl-201 495 73.1 (1.976) ln-111 6 0.05 (0.0014)

Ga-67 158 56.8 (1.535)

Xe-133 121 103.6 (2.800) 1-131 222 164.4 (4.442) 1-123 96 0.7 (0.018)

Sr-89 4 0.6 (0.016)

Totals 4365 3240.2 (87.572)

TABLE 4 Annual Radioactive discharges from NIH - GBq (Ci)

Nuclides 1990 1991 1992 1993 H-3 109.4 (2.956) 91.5 (2.473) 101 .0 (2. 730) 112.2 (3.032)

C-14 2.1 (0.056) 1.2 (0.032) 1.0 (0.026) 1.2 (0.032)

All others 107.8 (2.914) 152.2 (4.114) 131.1 (3,543) 79.2 (2.141)

DOCKETED Council on .fB.SJlifiluclides and Radiopharmaceuticals, Inc.

3911 Campolindo Drive Moraga, CA 94556-1551

• 94 JUN - 2 P3 :18 510/283-1850 Fax: 510/283-1850 Henry H. Kramer, Ph.D., FACNP OFFIC E OF SE CRETN~Y Executive Director OOCKE flN G & SER' ' ICF B .ANCd Secretary of the Commission U.S. Nuclear Regulatory Commission Washington, DC 20555 DOCKET NUMBER PROPOSED RULE PR 'J__Q Attention: Docketing and Service Branch CsctFP.C/JL/~

Date: 5/18/94

Subject:

Federal Register Vol. 59, No. 38, Friday, February 25, 1994.

Advanced notice of proposed rulemaking: Disposal of Radioactive Material by Release into Sanitary Sewer Systems

Dear Mr. Chilk,

The attached comments on the above referenced subject are submitted on behalf of the Council on Radionuclides and Radiopharmaceuticals, Inc. (CORAR). CORAR is comprised of representatives of the major manufacturers and distributors of radiopharmaceuticals, radioactive sources and research radionuclides used in the USA for therapeutic and diagnostic medical applications and for industrial, environmental and biomedical quality control and research.

The manufacture of radioactive materials involves the use of process water and cleaning materials that can be slightly contaminated with radioactive materials and that are subsequently disposed into sanitary sewers. Also the use of radioactive products in nuclear medicine i-)fOCt!dures result., in the disposal of contaminated patient excreta in sanitary sewers. Because of these activities NRC considerations of rulings for disposal into sewers apply to CORAR operations and those of our customers.

CORAR appreciates the need to regulate the disposal of radioactive materials in sanitary sewer. It appears that recent changes in the revised 10 CFR 20 regulations should be more than sufficient to protect sewage treatment plants. We believe it to be inappropriate for the NRC to license sewage treatment plants. In those rare occasions where treated sewage results in contaminated ashes or sludges the NRC should consider imposing more restrictive license conditions to major contributing sources.

lrs-5-18-94 JUL 2 1 1994 Acknowledged by card ...- .....-.-*...... N

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~NOCU:1-\ I h-*-,1...AfC'liY CCJMMTSSION DOCKETING & SERVICE SECTION OFFICE OF THE SECRET ARV OF lHE COMMISSIOf'l Document StatistiCS Postmark.Date 5 J,t...6(C/'1 O)pies Received _ ____ _ _ __

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We appreciate the opportunity to comment on this advanced notice of rulemaking.

Please call or write if you need clarification or any further information.

Sincerely yours,

~ --/ll Leonard R. Smith, CHP Chairperson of CORAR Committee on Sewer Dif:posa! Reguhtions lrs-5-18-94

CORAR COMMENTS ON THE ADVANCED NOTICE OF PROPOSED RULEMAKING: DISPOSAL OF RADIOACTIVE MATERIAL BY RELEASE INTO SANITARY SEWER SYSTEMS

1. a. Doses due to radioactive materials to members of the public and sewage treatment plant workers are known to be generally very low.

b. The NRC does not appear to have determined that actual individuals have received doses exceeding public dose limits even in those few cases where measurable radioactivity was determined in sewage treatment plants.

Instead the NRC has presenter:J conservative dose estimates which also indicate very little potential for over exposure.

c. The NRC should determine the actual collective dose to be adverted to justify any substantial regulatory change.

2. Eftluent concentration limits for disposal into sanitary sewers were recently reduced in the revised 10 CFR 20 by about a factor of ten. Since historic contamination cases relate to a period when much higher limits were in effect it appears prudent for the NRC to delay any regulatory changes pending a study to determine the effect of these new regulations.

3. It is not clear in the NRC case studies whether radionuclides were disposed in excess of existing regulatory requirements. It is apparent that the physical forms were not dispersible. It would be inappropriate for the NRC to respond to individual violations of regulatory requirements by making changes to the regulations for all licensees.

4. a. The NRC should establish concentration and quantity limits that ensure that public dm;es are maintained below the 100 mrem/year limit at the majority of sewage treatment plants. In unusual cases where the number of*

licensees, size of the sewage treatment plant or nature of the technology used at the treatment plant implies higher doses, the NRC should consider placing additional restrictions on licenses to provide the necessary protection.

b. It would be inappropriate for the NRC to license sewage treatment plants.

Licensing does not provide a solution to preventing contamination of these plants.

lrs-5-18-94

5. In determining appropriate limits the NRC should distinguish between those radionuclides and chemical forms that significantly concentrate in treatment plants and those that do not.

6. The NRC should continue current concentration limits and exemptions for soluble and biological materials in effluent and reestablish (stricter) limits for non-biological, non-soluble dispersible materials.

7. The NRC should model sewer disposal to predict actual doses measured. The current model assuming direct drinking of licensee effluent is not a plausible

,posu;-e path. Th~ model needs to r~alisti~a!ly consider the a~tual influent to the plant from both licensees and other users to determine more realistic dilution factors. The model should consider that sewage contains many materials more hazardous than radioactivity that requires isolation and special handling to avoid personnel exposure.

8. It will be impractical and potentially hazardous to sample patient excreta. If there is any net benefit it is unlikely that it will be sufficient to justify the cost, particularly since much of the patient excreta will be disposed from households.

Also there is no need for sampling since contamination levels are very low.

9. Ohio's request for 24 hour2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> notice on radionuclides released to the sanitary sewer is impractical since every user including households releases small amounts of radionuclides every time effluent is disposed in the sewer. It might make sense that sewage treatment plants be notified oflarge accidental releases. However, this reporting capability already exists. It is not, of course, possible to predict an accidental release 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br />, in advance, by definition.

lrs-5-18-94

DOCKET NUMBER PR 2-.0 Edwin A Wurtz, PhPoROPOSED RULE..::...::.:..----- Merck & Co , Inc.

Associate Director ( 5C{ f ~ C/ / 1-f 61 KET ED PO. Box 4, WP42-212 Health Physics. Bi osafety, '/ 00 C West Point PA 19486 and Environmental Affairs US RC Fax 215 652 2290 Tel 215 652 4890

• 94 JUN -1 p 1 :21 May 25, 1994 OF FICE OF SECRETARY DOCKETING &. ~ER ICE The Secretary of the Commission BRA CH 0 MERCK Research Laboratories U.S. Nuclear Regulatory Commission Washington, D.C. 20555 ATIN: Docketing and Service Branch RE: Advanced Notice of Proposed Rulemaking: Disposal of Radioactive Material by Release into Sanitary Sewer Systems (Federal Register, Vol. 59, No. 38, pp. 9146 - 9149)

Merck & Co., Inc. is a large multinational pharmaceutical company with corporate headquarters in Whitehouse Station, NJ. The company pursues a rigorous research and development program in human and animal health through its research division, Merck Research Laboratories (MRL). The use of radionuclides is a critical component in many ofMRL's research programs. The proper and safe use of radioactive material, as well as, the safe and efficient disposal of radioactive waste are primary goals ofMRL's health physics program.

The MRL Department of Health Physics, Biosafety & Environmental Affairs doesn't believe that there is a need for additional restrictions to the current regulations governing the release of radionuclides to sanitary sewer systems. The current regulations have maintained the radiation dose to members of the public to well below the 100 mrem/year limit stipulated in 10 CFR 20 .1302, Compliance with Dose Limits for Individual Members of the Public. The six case studies presented in the federal register indicate that no individual (even in these highly unusual situations) received a radiation dose in excess of the 10 mrem/y ALARA guideline recommended in Regulatory Guide 8 .3 7, ALA.RA Levels for EfJluents from Materials Facilities.

If the Commission feels compelled to amend the regulations in view of the findings of NUREG/CR-5814, Evaluation of Exposure Pathways to Man From Disposal ofRadioactive Material Into Sanitary Sewer Systems, then the Commission should limit its changes to the handful of potentially problematic radionuclides. As presented in the table below, the range of potential radiation doses arising from the sewer disposal of radionuclides typically used in biomedical research are well within the Regulatory Guide 8.37 recommendations for ALARA effluents.

RADIATION DOSES CALCULATED IN NUREG/CR-5814 FOR RADIONUCLIDE DISCHARGES OF 1 CURIE PER YEAR TO A 5 MILLION GALLON PER DAY SEWAGE TREATMENT PLANT Radionuclide Maximum Radiation Dose Minimum Radiation Dose

---

H-3 (mrem/ )

1. 6E-04 4 .lE-02 (mrem/

< 1. OE-07 3.0E-06 C-14 P-32 1 .2E+OO < 1. OE-07 P-33 1 .2E-Ol < 1.0E-07 S-35 4 .4E-02 1-125 6 .8E-01 < 1.0E-07 Acknowl ad by JUL 2 1 1994--.

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Secretary of the Commission May 25, 1994 2 Changes in the sewer disposal regulations could have a detrimental impact on the management of certain radioactive waste streams. Therefore, Merck feels that it is necessary to comment on the topics published in the Federal Register notice. For clarity, the topics are presented in bold italics and our response follows.

THE POTENTIAL IMPACTS ON LICENSEE'S OPERATIONS ASSOCIATED WITH ANY ADDITIONAL RESTRICTIONS REGARDING FORMS OF MATERIAL SUITABLE FOR DISPERSAL Merck does not support any additional restrictions regarding forms of material suitable for dispersal. 10 CFR 20 states that only readily soluble or readily dispersible biological material is satisfactory for disposal by release into sanitary sewerage. Considering that the design of sewage treatment plants is to process readily dispersible biological material; the need to further restrict this waste form isn't clear. However, if the ability to dispose of this waste form to the sanitary sewer was restricted there would be a major impact on waste management practices. For example, in large animal in-vivo studies large volumes of excreta containing low radionuclide concentrations are directly washed into the sanitary sewer system (with proper evaluation and recordkeeping). If this disposal method was no longer available, the large volume of excreta (containing very little licensed material) would have to be contained, packaged, transported and stored prior to disposal.

All of this extra handling increases the potential for personnel radiation dose from the raw, undiluted waste. The increased radiation exposure to caretakers and costs for waste handling do not appear to be outweighed by the slight reduction in calculated radiation doses to members of the public that are already far below federal limits.

Additionally, further restrictions in the sewer disposal regulations would lead to a sizable increase in the volume of radioactive waste for interim storage at biomedical research facilities. Since this increase wasn't foreseen, the existing facilities designated for interim storage may not have the necessary capacity. Therefore, it will be necessary for organizations to increase capital spending on storage facilities.

The suggestion of further restrictions on sewer disposal appears to contradict the ALARA philosophy, considering the increased radiation exposure to personnel and increased costs of waste handling at biomedical research institutions versus the minimal reduction in radiation doses to members of the public.

THE POTENTIAL IMPACT ON LICENSEE'S OPERATIONS ASSOCIATED WITH FURTHER RESTRICTIONS ON THE TOTAL QUANTITY OF RADIOACTIVE MATERIAL THAT COULD BE RELE4SED DURING A YE4R.

Merck does not support further restrictions on the total quantity of radioactive material that could be released during the year. The same general arguments and conclusions presented above would apply to this proposal.

TO REQUIRE AT LE4ST 24 HOURS ADVANCE NOTICE TO THE APPROPRIATE SEWAGE TRE4TMENT PLANT BEFORE RELE4SING RADIOACTIVE MATERIAL TO THE SANITARY SEWAGE SYSTEM.

Merck does not support the idea of 24 hour2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> notification prior to discharge. The utility of this proposal is not clear. What benefit is derived from this notification? What action would the

Secretary of the Commission May 25, 1994 3 operator of a sanitary sewerage system take? This requirement would become burdensome to large facilities that have routine discharges, requiring almost daily notification of the appropriate sewage treatment plant.

SHOULD THE COMMISSION CONSIDER LIMITATION USING A DOSE LIMIT APPROACH, AND PROVIDE TOTAL QUANTITY AND CONCENTRATION VALUES IN A REGULATORY GUIDE TO FACILITATE COMPLIANCE WITH THE DOSE LIMIT?

Merck supports the use of a dose limit approach to sewer disposal regulations. From the radiation dose values presented in NUREG/CR-5814, it appears that the current sewer disposal regulations are more restrictive than other effluent stream requirements. If the appropriate models are developed, like those in NUREG/CR-5814, there should be no reason for sewer disposal to be handled differently than any other facility effluent. Using this approach, facility discharges and associated public radiation doses could be controlled under the requirements of 10 CFR 20.1302, Compliance with Dose Limits for Indfridual illembers of the Public, or tht: ALARA guideiine recommended in Regulatory Guide 8.37, ALA.RA Levels for Efj1uents from Materials Facilities.

THE APPROPRIATENESS OF CONTINUING THE EXEMPTION FOR PATIENT WASTES.

Merck concurs with the Commission's assessment that the current regulation is adequate. We can not identify any benefit to regulating patient excreta; however, the cost of an extended hospital stay or the potential exposures to family members from the handling and storage of patient excreta are obvious.

I am sure that this comment will receive careful review and consideration before the publication of a proposed rule change. If you require additional information on this matter, I would welcome the opportunity to discuss this topic with a member of the NMSS staff.

~u.Jdy Edwin A. Wurtz, Ph.D.

Associate Director, Health Physics, Biosafety, and Environmental Affairs Merck Research Laboratories j :\wurtz\sew_ comm.doc

~ MERCY HOSPITAL DOCKETED USNRC DOCKET NUMBER PR BOPOSED RULE~_2 c..,.r-,...

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May 25, 1994

{5Cf F~ c!flLfb) *94 JUN -1 Pl :20 Secretary of the Commission US Nuclear Regulatory Commission OFFICE OF SECRETARY Washington DC, 20555 DOCKETING & SERVICE BRANCH Attention : Docketing and Service Branch

Dear Sir(s):

As a nuclear medicine supervisor in a 200 bed community hospital in Maine, I would like to accept your offer to comment on the possible changes that would further restrict release of radioactive waste into the sanitary system.

I strongly recommend that present exemptions to patient excreta, whether from diagnostic or therapeutic procedures, NOT be changed. The collection and storage of this material would cause unneccesary exposure and unacceptable working practices and conditions for healthcare workers.

The added expense to facilities attempting to safely store this waste would be unreasonable in light of the fact that the material is soluble/readily dispersible, and short-lived. I believe the current practice is safe and the most practical approach.

I thank the commission for the opportunity to express my viewpoints.

Yours truly, Charles C Keogh BS, CNMT, RT(R)

Supervisor-Nuclear Medicine Ul 2 t 1994 144 State Street, Portland, Maine 04101 -3795 207-879-3000

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DOCKETED USHRC TUFTS UNIVERSITY *94 JUN -1 p 1 :20 School of Veterinary Medicine OFFICE OF SECRETARY Department of Comparative Medicine DOCKETING &1 SERVICE BRA CH t)OOKET NUMBER May 25, 1994 PROPOSED RULE PR 2 O (5°! F A q 1'-16)

Secretary of the Commission US Nuclear Regulatory Commission Washington, DC 20555 Attn: Docketing and Service Branch Gentlemen:

This is in response to the request for comments on the current policy for disposal of radioactive material by release into sanitary sewerage systems. Following is our position on this issue:

1. Form of material released: The most recent regulations restrict sewerage disposal to materials that are soluble or readily dispersible biological materials. We believe that any prior c6ncerns for concentration of non-biological readily dispersible material are resolved by the new restriction to biological materials and are unaware of any significant problems with soluble material. We therefore recommend continuation of this allowed release form.

2. Total quantity of material: although these unchanged limits easily meet the needs of most licensees, it seems appropriate, given the new restriction on form of material released and the new more restrictive release concentrations, to consider relaxation of these limits for large users sine~

reconcentration should be much less of a concern. It may even be practical to eliminate such an upper cap totally, depending only on concentration restriction with the reduced limits now in effect. We have never seen the logic in applying the same cap to a large program with thousands of users as is applied to a small one with only a few users.

200 Westboro Road North Grafton, Massachusetts 01536 (508) 839-5302 2 1 1 ---....

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Secretary of the Commission Page 2.

3. Types of limits: The present method of limitation based on an individual being exposed by ingestion of water from the sewer outfall seems to be sufficiently conservat i ve to satisfy all needs, particularly in view of the new lower release concentrations. This is readily controllable in the workplace and is easily understood for radionuclide users. Proper adherence to concentration limits would appear to negate the need for an upper cap as mentioned in item 2 above.

4. Exemption of Patient Excreta: continuation of this important exemption is encouraged as a significant ALARA consideration.

Collection and control of patient excreta would result in the deliberate reconcentration of a significant waste stream with the potential for worker exposure, spills, and emergency issues that have been avoided through the judicial use of this exemption. The rapid dispersal of this soluble waste stream of short-lived material seems the most practical approach to this issue and we strongly recommend the continuation of the exemption in its current form.

We thank the commission for the opportunity to comment on this important issue and look forward to commenting on any proposed regulations that are forthcoming.

Yours truly, Acacia Alcivar-Warren, D.V.M., Ph.D.

Assistant Professor

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HARVAl[JOOK[Cf'K f3C HOOI DEPARTMENT OF RADIOLOGY BRIGHAM USHRC AND WOMEN'S HOSPITAL

• 94 JUN -1 P 1 :19 7S Francis Street Boston, MA 02115 (617) 7326203

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OFF ICE OF SEC RE fARY DPROCOPKOETSENDUMRUBELER DOCKETING & SERVICE PR 2.0 BRAHC~ 5 May 1994 ( ft re F q !'76)

Secretary of the Commission Nuclear Regulatory Commission Washington, DC 20555 Attention: Docketing and Service Branch re: Disposal of radioactive materials by release into the sanitary sewer system Sir:

I write to express concern about proposal s to reevaluate the sewer disposal limits of 10CFR20.

Although I have not had access to the contractors ' reports, I suspect most local accumulation in the sewers and treatment systems can be dealt with locally and without specific attention of the NRC, especially if the nature of the accumulation is such as to reflect also the accumulation of other more hazardous, nonradioactive materials as well.

For medical research and biotechnology laboratories, the present sewer limits afford the major means for source reduction of low-level radioactive waste. And the sewer system receives many other forms of hazardous chemical and biological materials.

The form of permitted disposal must be evaluated in relationship to the carriers via nonradioactive, proven accumulation. The total quantity limits presently applied are adequate. The limits should be related to activity, not dose; if a local dose exceeding limits is detected, local amelioration must be accomplished. Ingestion of sewer outfall, of course, is an absurd assumption. Patient excreta should continue exempted from the limits; any local retention would be a rank violation of ALARA principles and biologically unacceptable.

I support the Commission's belief that the present regulations are adequate.

Sincerely yours,

~f~

David E. Drum, MD, PhD, CHP

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USNRC TUFTS UNIVERSITY *94 JUN -1 P1 :13 May 25, 1994 OFFI CE OF SECRETARY Department of Biology OOCKE TIHG & SEIWICE BRANCH tJOCKET NUMBER Secretary of the Commission US Nuclear Regulatory Commission PROPOSED RULE PR 2-C>

Washington, DC 20555 {_f Cf FR CJ I '-/6)

Attention: Docketing and Setvice Branch

Dear Secretary:

This is in response to the request for comments on the current policy for disposal of radioactive material by release into sanitary sewerage systems. Following is my position on this issue:

1) Form of material released: The most recent regulations restrict sewerage disposal to materials that are soluble or readily dispersible biological materials. I believe that any prior concerns for concentration of non-biological readily dispersible material are resolved by the new restriction to biological materials and am unaware of any significant problem with soluble material. I therefore recommend continuation of this allowed release form.

2) Total quantity of material: Although these unchanged limits easily meet the needs of most licensees, it seems appropriate, given the new restriction on form of material released and the new more restrictive release concentrations, to consider relaxation of these limits for large users since reconcentration should be much less of a concern. It may even be practical to eliminate such an upper cap totally, depending only on concentration restriction with the reduced limits now in effect. I have never seen the logic in applying the same cap to a large program with thousands of users as is applied to a small one with only a few users.

3) Types of limits: The present method of limitation based on an individual being exposed by ingestion of water from the sewer outfall seems to be sufficiently consetvative to satisfy all needs, particularly in view of the new lower release concentrations. This is readily controllable in the workplace and is easily understood for radionuclide users. Proper adherence to concentration limits would appear to negate the need for an upper cap as mentioned in item 2 above.

4) Exemption of Patient Excreta: Continuation of this important exemption is encouraged as a significant ALARA consideration. Collection and control of patient excreta would result in the deliberate reconcentration of a significant waste stream with the potential for worker exposure, spills, and emergency issues that have been avoided through the judicial use Medford, Massachusetts 02155-7009 617 627-3195 FAX 617 627-3805 'JUL 2 1 1994' cknow edged by cat N ..... NtNNN ...... HIHNfft#

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Secretary of the Commission May 25, 1994 Page 2 of this exemption. The rapid dispersal of this soluble waste stream of short-lived material seems the most practical approach to this issue and I strongly recommend the continuation of the exemption in its current form.

I thank the commission for the opportunity to comment on this important issue and look forward to commenting on any proposed regulations that are forthcoming.

Sincerely,

~UML R.~!\~~

June R. Aprille Henry Bromfield Pearson Professor of Natural Sciences Professor of Biology JRNjc

DOCKET NUMBER PR 'J O PROPOSED RULE~;..:;. ~- - -

P Hale (_r; d/ FR o/11--16) DOCKETED Ill Hospital USNRC affiliated with 140 Lincoln Avenue Haverhill, MA 01830 '94 JUN -1 P1 :21 QJ),UM HIAI I H Rf~ l<<._l~ l'\l.

508 374-2000 OFFICE OF SECRETAR Y DOCKETING & SEP !Cf May 24, 1994 BRAHCH Secretary of the Commission US Nuclear Regulatory Commission Washington, DC 20555 Attention: Docketing and Service Branch Gentlemen, This is in response to the request for comments on the current policy for disposal of radioactive material by release into sanitary sewage systems. Following is our position on this issue:

1. Form of material released: The most recent regulations restrict sewerage disposal to materials that are soluble or readily dispersible biological materials. We believe that any prior concerns for concentration of nonbiological readily dispersible material are resolved by the new restriction to biological materials and are unaware of any significant problems with soluble material. We therefore recommend continuation of this allowed release form.

2. Total quantity of material: Although these unchanged limits easily meet the needs of most licensees, it seems appropriate, given the new restriction on form of material released and the new more restrictive release concentrations, to consider relaxation of these limits for large users since reconcentration should be much less of a concern. It may even be practical to eliminate such an upper cap totally, depending only on concentration restriction with the reduced l i mi ts now in effect.

We have never seen the logic in applying the same cap to a large program with thousands of users as is appl ied t o a small one with only a few users.

3. Types of limits: The present method of limitation based on an individual being exposed by ingestion of water from the sewer outfall seems to be sufficiently conservative to satisfy all needs, particularly in view of the new lower release concentrations. This is readily controllable in the workplace and is easily understood for radionuclide users. Proper adherence to concentration limits woul d appear to negate the need for an upper cap as mentioned in item 2 above.

4. Exemption of Patient Excreta: Continuation of this important exemption is encouraged as a significant ALARA consideration.

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Collection and control of patient excreta would result in the deliberate reconcentration of a significant waste stream with the potential for worker exposure, spills, and emergency issues that have been avoided through the judicial use of this exemption.

The rapid dispersal of the soluble waste stream of short lived material seems the most practical approach to this issue and we strongly recommend continuation of the exemption in it's current form.

We thank the commission for the opportunity to comment on this important issue and look forward to commenting on any proposed regulations that are forthcoming.

Yours Truly, I(~ ?k~

Kirwan T. MacMillan, M.D.

Radiation Safety Officer Director, Nuclear Medicine

NEW ENGLAND REGIONAL NEWBORN SCREENING PROGRAM STATE LABORATORY INSTITUTE 305 SOUTH STREET DOC 'ETEDTEL: (617) 522-3700 JAMAICA PLAIN , MA 02130-3523 USN r, FAX: {617) 522-2846

'94 JUN - 1 P1 :13 NEWBORN DISORDERS:

A REGIONAL CONCERN May 24, 199 FFICE OF SECRETARY OOCKETH G & SE. /IC:=

BRANCH DOCKET NUMBER R PROPOSED RULE p A (J Samuel J. Chilk (S1 F R '1l'-1 6)

Secretary of the Commission US Nuclear Regulatory Commission Washington, DC 20555 Attention: Docketing and Service Branch

Dear Mr. Chilk:

This is in response to the request for comments on the current policy for disposal of radioactive material by release into sanitary sewerage systems. Following is our position on this issue:

(1) Form of material released: The most recent regulations restrict sewerage disposal to materials that are soluble or readily dispersible biological materials.

We believe that any prior concerns for concentration of non-biological readily dispersible material are resolved by the new restriction to biological materials and are unaware of any significant problems with soluble material. We therefore recommend continuation of this allowed release form.

(2) Total quantity of material: Although these unchanged limits easily meet the needs of most licensees, it seems appropriate, given the new restriction on form of material released and the new more restrictive release concentrations, to consider relaxation of these limits for large users since reconcentration should be much less of a concern. It may even be practical to eliminate such an upper cap totally, depending only on concentration restriction with the reduced limits now in effect. We have never seen the logic in applying the same cap to a large program with thousands of users as is applied to a small one with only a few users.

(3) Types of limits: The present method of limitation based on an individual being exposed by ingestion of water from the sewer outfall seems to be sufficiently conservative to satisfy all needs, particularly in view of the new lower release concentrations. This is readily controllable in the workplace and is easily understood for radionuclide users. Proper adherence to concentration limits would appear to negate the need for an upper cap as mentioned in item 2 above.

edbv . JUL 21 l ~

The NERNSP is operated in cooperation with the Mass. Dept. of Public Health and the Mass. Health Research Institute.

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Samuel J. Chilk May 24, 1994 (4) Exemption of Patient Excreta: Continuation of this important exemption is encouraged as a significant ALARA consideration. Collection and control of patient excreta would result in the deliberate reconcentration of a significant waste stream with the potential for worker exposure, spills, and emergency issues that have been avoided through the judicial use of this exemption. The rapid dispersal of this soluble waste stream of short-lived mate1*ial seems the most practical approach to this issue and we strongly recommend the continuation of the exemption in its current form.

We thank the commission for the opportunity to comment on this important issue and look forward to commenting on any proposed regulations that are forthcoming.

Marvin L. Mitchell, M.D.

Chief of Endocrinology

- MLM/k

Environmental MASSACHUSETTS INSTITUTE OF TECHN@OKE1ED Medical USHRC MEDICAL DEPARTMENT Service Bates Radiation Protection Q ~~e JUN -1 p 1 :21 Bates linear Accelerator Center PO Box 95, 21 Manning Road f SECRETARY (617) 253-9217 Middleton MA Ol949-010t F~f 1?tm & SERVICE FAX (617) 253-9599 DOC BRANCH May 23, 1994 DOCKET NUMBER Secretary of the Commission PROPOSED RULE PR 2__()

US Nuclear Regulatory Commission (SCf Fn. C/t'-f i,)

Washington DC 20555 Attention: Docketing and Service Branch RE: Release of By Product Materials into Sanitary Sewerage Systems Gentlemen:

This is in response to the request for comments on the current policy for disposal of radioactive material by release into sanitary sewerage systems. Following is our position on this issue:

( 1) Form of material released: The most recent regulations restrict sewerage disposal to materials that are soluble or readily dispersible biological materials. We believe that any prior concerns for concentration of non-biological readily dispersible material are resolved by the new restriction to biological materials and are unaware of any significant problems with soluble material. We therefore recommend continuation of this allowed release form.

(2) Total quantity of material: Although these unchanged limits easily meet the needs of most licensees, it seems appropriate, given the new restriction on form of material released and the new more restrictive release concentrations, to consider relaxation of these limits for large users since reconcentration should be much less of a concern. It may even be practical to eliminate such an upper cap totally, depending only on concentration restriction with the reduced limits now in effect. We have never seen the logic in applying the same cap to a large program with thousands of users (e.g. a large university with a broad license) as is applied to a small license with only a few users.

(3) Types of limits: The present method of limitation based on an individual being exposed by ingestion of water from the sewer outfall seems to be sufficiently conservative to satisfy all needs, particularly in view of the new lower release concentrations. This is readily controllable in the workplace and is easily understood

1.,;__, * * - ** ~-- ... c:CIION OFFIGr: S:)r (HE SECRETARY Of. ThE COMMISSION Co~t.::r,c:nt Statistics Postmark Date otL/

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US Nuclear Regulatory Commission May 23, 1994 Page 2 by radionuclide users. Proper adherence to concentration limits would appear to negate the need for an upper cap as mentioned in item 2 above. Elimination of the cap would greatly simplify the record-keeping in a larger program.

(4) Exemption of Patient Excreta : Continuation of this important exemption is encouraged as a significant ALARA consideration.

Collection and control of patient excreta would result in the deliberate reconcentration of a significant waste stream with the potential for worker exposure, spills, and emergency issues that have been avoided through the judicial use of this exemption. The rapid dispersal of this soluble waste stream of short-lived material seems the most practical approach to this issue and we strongly recommend the continuation of the exemption in its current form.

We thank the commission for the opportunity to comment on this important issue and look forward to commenting on any proposed regulations that are forthcoming.

Yours truly,

/

~fill~

F . X. Masse, CHP, CMP Director, Radiation Protection Program FXM/nlj

oocKETED One Kendall Square US, RC Mitotix Building 600 Cambridge. MA 02139 INCORPORATED

, A JUN -1 p 1 :13 Tel 617 225 0001 9<+ Fax 617 225 0005 May 23, 1994 Oh \Ct. Of __sECJETAfcl OOCKET\ { u &. --:ER\I Secretary of the Commission BRA,CH US Nuclear Regulatory Commission DOCKET NUMBER Washington, DC 20555 PROPOSED RULE PR 2 0 Attention: Docketing and Service Branch ( SC, FR Cf IL/&,)

Gentlemen:

This is in response to the request for comments on the current policy for disposal of radioactive material by release into sanitary sewerage systems. Following is our position on this issue:

(1) Form of material released: The most recent regulations restrict sewerage disposal to materials that are soluble or readily dispersible biological materials.

We believe that any prior concerns for concentration of non-biological readily dispersible materials are resolved by the new restriction to biological materials and are unaware of any significant problems with soluble material. We therefore recommend continuation of this allowed release form.

(2) Total quantity of material: Although these unchanged limits easily meet the needs of most licensees, it seems appropriate, given the new restriction on form of material released and the new more restrictive release concentrations, to consider relaxation of these limits for large users since reconcentration should be much less of a concern. It may even be practical to eliminate such an upper cap totally, depending only on concentration restriction with the reduced limits now in effect.

We have never seen the logic in applying the same cap to a large program with thousands of users as is applied to a small one with only a few users.

(3) Types oi iimits: The present meihou of lirniiaiio11 ba::;&d on an individual being exposed by ingestion of water from the sewer outfall seems to be sufficiently conservative to satisfy all needs, particularly in view of the new lower release concentrations. This is readily controllable in the workplace and is easily understood for radionuclide users. Proper adherence to concentration limits would appear to negate the need for an upper cap as mentioned in item 2 above.

(4) Exemption of Patient Excreta: Continuation of this important exemption is encouraged as a significant ALARA consideration. Collection and control of patient excreta would result in the deliberate reconcentration of a significant waste stream with the potential for worker exposure, spills, and emergency issues that have been avoided through the judicial use of this exemption. The rapid dispersal of this soluble waste stream of short-lived material seems the most practical approach to this issue and we strongly recommend the continuation of the exemption in its current form.

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We thank the commission for the opportunity to comment on this important issue and look forward to commenting on any proposed regulations that are forthcoming.

Yours truly,

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Giulio F. Draetta, M.D., Ph.D.

Vice President of Biological Research

D\,,-..;I ... I" NU,.1BER PR PROPOSED RULE 20 New England Medical Center (S'1 FR Cf I'-/ t,,J DOCKETED May 23, 1994 US RC

'94 D - t P1 :21 Secretary of the Commission US Nuclear Regulatory Commission Washington DC 20555 OFFICE Of SECREt RY DOCKETI .. ~ .I&.. .M.P.

Attention: Docketing and Service Branch BR fftU,ld.>n Safety Offiar RE: Release of By Product Materials into Sanitary Sewerage Systems NEMC#787 750 Washington Street Boston, Massachusetts 02111 Gentlemen:

Tel: (617) 956-6168 This is in response to the request for Fax: (617) 9S6-5353 comments on the current policy for disposal of radioactive material by release into sanitary sewerage systems. Following is our position on this issue:

( 1) Form of material released: The most recent regulations restrict sewerage disposal to materials that are soluble or readily dispersible biological materials. We believe that any prior concerns for concentration of non-biological readily dispersible material are resolved by the new restriction to biological materials and are unaware of any significant problems with soluble material.

We therefore recommend continuation of this allowed release form.

(2) Total quantity of material: Although these unchanged limits easily meet the needs of most licensees, it seems appropriate, given the new restriction on form of material released and the new more restrictive release concentrations, to consider relaxation of these limits for large users since reconcentration should be much less of a concern. It may even be practical to eliminate such an upper cap totally, depending only on concentration restriction with the reduced limits now in effect. We have never seen the logic in applying the same cap to a large program with thousands of users (e . g. a large university with a broad license} as is applied to a small license with only a few users.

(3) Types of limits: The present method of limitation based on an individual being exposed by ingestion of water from the sewer The principal teaching hospital for Tufts University School of Medicine JL 2

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US Nuclear Regulatory Commission May 23, 1994 Page 2 outfall seems to be sufficiently conservative to satisfy all needs, particularly in view of the new lower release concentrations. This is readily controllable in the workplace and is easily understood by radionuclide users. Proper adherence to concentration limits would appear to negate the need for an upper cap as mentioned in item 2 above. Elimination of the cap would greatly simplify the record-keeping in a larger program.

(4) Exemption of Patient Excreta: Continuation of this important exemption is encouraged as a significant ALARA consideration.

Collection and control of patient excreta would result in the deliberate reconcentration of a significant waste stream with the potential for worker exposure, spills, and emergency issues that have been avoided through the judicial use of this exemption. The rapid dispersal of this soluble waste stream of short-lived material seems the most practical approach to this issue and we strongly recommend the continuation of the exemption in its current form.

We thank the commission for the opportunity to comment on this important issue and look forward to commenting on any proposed regulations that are forthcoming.

Yours truly, I'

fx)[fu,~

F.X. Masse, CHP, CMP Radiation Safety Officer Chairman, Radiation Safety Committee FXM/nlj

D ENVIRONMENTAL COALITION ON NUCLEAR POWER PR Dr. Judith Johnsrud, Director 433 Orlando Averue, Stat~ t f !Q16803 814-237-3900 Hay 20, 199!)SHRC t;ji'1 Secre t ary of the Commission RE: ANPR, 59 FR 9~§, i~!ilf9~ *fljsposall.2._Y U.S. Nuclear Regulatory Commission of Radioactive Mat1tlal by Release Washington, D.C. 20555 into Sanitary Sewer Systems OFFICE OF SECRETARY

Dear Madam or Sir:

OOCKETlNG & SERVICE BRANCH These comments are submitted on behalf of the Pennsylvania-based Environ-mental Coalition on Nuclear Power. They address the Commission's proposed rule on disposal by release of radioactive material in san i tary sewage systems.

Comments on Background and Discussion:

We commend those parts of the Commission's actions, in the May 1991 10 CFR Part 20 revision, that disallowed disposal of dispersible materials into sewers and reduced by a factor of ten the permissible concent rations of radionuclides released to sewers. They move in the right regulatory direction.

However, we note that the assumption of dilution at the point of water intake that is adequate to reduce a calculated individual dose from 500 mre /yr at the point ot outfall to a level below the 100 mrem/yr dose to a member of the public is Q.D..!.y an assumption. These assumptions should have been, and now should be, verified with ample clear evidence - not mere calculational models.

Obviously, the concentrations and dilutions will depend upon a number of factors, including but not limited to distance from outfall to drinking water intake, water composition, volume and flow variations, turbulence, water treatment, multiple sources ot releases, and other conditions. Because of the number and variety of uncertainties and confounding factors, the standards should be set most conservatively, assuming always truly worst case conditions and incorporating all unknowns and variables into the analysis.

The FR notice cites cases ot contamination and reconcentration but the Commission appears to believe that, because they occurred prior to implementa-tion of the revised 10 CFR Part 20, they cannot recur. This is not so.

We strongly urge that the 20.2003 exemption tor medical recipient excreta, also cited in the Discussion section, should be removed; these contributions, while assumed to be a short - lived and small contribution, are an additive exposure and may therefore be of significance to the health ot others.

In the same section, the reconcentration modeling assumption that is de-scribed takes no account of potential accidental releases in excess of the Part 20 limit. Thus, the total effective dose equivalent exposures calculated may well represent dose levels well below what might be experienced in the real world where the unexpected often happens. To assure adequate conservatism, in view of rapidly changing medical and scientific opinion about adverse effects of chronic low- dose exposures to ionizing radiation greater than are recognized in Part 20 and the impacts of synergisms among radiation and other environ-mental contaminants, the rule should be more restrictive than is proposed.

L 21 1

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Page 2 <Comments on 59 FR 9146>

Responses to Request for Information and Comment:

The Commission states that it is seeking in particular information on the "impacts [of various options) on various types of licensees." It is the Com-mission's statutory role to seek information on the impacts of radioactive materials and wastes on those who are exposed to them, not on those entities that do the releasing of the materials, thereby placing in jeopardy the health and well-being of individual members of the public. There is here no compar-able expression of concern or inquiry about the impacts on the various sectors of the affected public (present or future>, in terms of their health damage and health costs, contamination of agricultural land, restriction of other land uses, other economic losses to affected areas, or environmental degradation.

(1) Form of the Material for Disposal: In devising regulations, the NRC should take into account the nature of, and both the positive and negative consequences of, existing and new technologies for sewage treatment, with added measures of conservatism to provide an extra safety cushion in the event of unanticipated negative effects. While a licensee is free to submit its opinion about impacts on its operations, those impacts are not, and must not be, the primary regulatory concern; health and safety are -- or should be. lf restrict-ions need to be increased because of treatment technology, then the Commission should do so, but complaints from generators of costs or burdens of compliance with stringent regulations designed to protect the public must be disallowed.

If the NRC does otherwise, it acts in an capricious and arbitrary manner with disregard for its legal mandates to protect health, safety, and environment.

(2J Total Quantity of Haterial: If the NRC has determined to limit the permissible total effective dose equivalent CTEDE> that a member of the public may receive annually on some basis of risk deemed "acceptable" to and by the Commission -- but with no opportunity for the potential recipient to determine acceptability -- then that limit should include all sources and pathways for emissions and effluents associated with a licensee's operations. There is no justification offered for the added dose from releases to a sewer, or for the presence of radionuclides in septage or in sewage sludge, or other releases with or without regulatory control. Yet each addition to total dose increases the risk ill health, cancers, genetic damage, or early death for the recipient.

Both the total quantity and a maximum for each radionuclide (in fractions, not multiples, of annual limits of intake> should be held to the minimum; both approaches should be applied, to attempt to assure the lowest possible (not merely "reasonably achievable") exposure for members of the public. No credits should be given for an advanced technology of treatment, but the adverse health and environmental impacts of multiple, additive, cumulative, and synergistic sources must be incorporated into the analysis and into release limits. To omit any potentially adverse impacts is also an arbitrary and capricious action by the agency and contrary to its charge under the Atomic Energy Act of 1954, as amended; the 1969 National Environmental Protection Act, the Energy Reorgan-ization Act of 1974, and the recent Pollution Prevention Act.

As for the Northeast Ohio Regional Sewer District petition <PRM-20-22),

the NRC should require a 24-hour notice if any radioactive materials are to be released. Since it is now recognized and accepted by the scientific community

Page 3 <Comments on 59 FR 9146) that there is no threshold of safe exposure to ionizing radiation, (see BEIR V Report> NRC should eliminate exemptions from regulatory control altogether.

(3) Type of limits: In response to the first question (continue l imita-tion based on ingestion of water from the sewer outfall): yes, but the permissible limit should be lowered from the 500 mrem/yr cited in the previous paragraph and incorporated into the maximum TEDE permitted for a member of the public from any aspect of operations of all licensed facilities. Sources should not be considered separately in calculating TEDE. We also contend that the maximum permissible total exposure should be set well below 100 mrem/yr for a member of the public, in recognition of no threshold and higher sensitivity of the young and the elderly. We urge monitoring at both outfall and intake.

As for the second part of this question (consider other locations): no; at any downstream location, some dilution will have taken place, with variations as described above. Measurement at outfall is equivalent to measurement at fence post in assessing dose to the maximally exposed person. Sewage sludge should be monitored separately and exposure limits should be no greater than, and incorporated with, those for "low-level" radioactive waste, if any activity is to be permitted in sewage and sludge. My sewage is your drinking water.

For the reasons given above, calculational models would not serve to protect the public adequately and should not be used. They cannot "deal with exposure scenarios such as contamination of sewage sludge" with enough accuracy to provide acceptable levels of protection for the public. Self-regulation should be disallowed; the industry has not merited such trust.

The second question asks if the NRC should consider limitation using a dose limit approach and provide quantity and concentration values. Yes; the dose limit should be substantially lower than the limit for "low-level" radio-active waste. And each affected municipality should also have the right to set standards more restrictive than those of NRC to protect its residents.

(4) Exemption of Patient Excreta: Sewer releases of patient excreta should not be exempted from regulatory control. Information Notice 94-09 (Release of Patients with Residual Radioactivity from Medical Treatment and Control of Areas Due to Presence of Patients Containing Radioactivity Following Implementation of Revised 10 CFR Part 20) is indicative of the relaxations of regulatory control which may affect public health and safety. Although the NRC notes nuclear medicines are generally short-lived, each amount released to a sewer is an addition, worsening the potential total contribution to TEDE, especially if NRC determines to abandon outfall measurement.

This commenter has observed, on more than one occasion, counts at or above 20,000 cpm in patients released but given no warning about high residual radio-activity after diagnosis and treatment with nuclear medicines. In one event, the patient had been assured that excreta to septic systems are of no health importance, indicating physicians' tendency to ignore multiple, additive, cumulative, and synergistic effects of environmental contaminants.

Comments on Case Studies:

Cases 1 and 2 -- Tonawanda and Grand Island, NY: Americium-241 is not short-lived. Its presence and other radioactive materials in sewage sludge may

Page 4 (59 FR 9146) presumably result in subsequent exposures via ingestion or inhalation, the latter especially if sludge is then spread on open fields. The fact that the particular workers tested did not exhibit detectable activity "over background levels" must not be used as justification for releases of radioactive materials to sewers or their presence in sludge. What level of activity was considered as "background" by NRC? "Naturally-occurring background" levels <c. 100-200 mrem/yr) or the augmented "background" figure that NRC now claims CNCRP's estimate of c. 300-400 mrem/yr, an average of 360 mrem/yr)? As the levels of activity may rise over years ahead -- due to increased numbers of generators, accidents, routine releases, deregulations, abandoned facilities, regulatory relaxation, or legislative changes -- the temptation and pressures to allow higher levels, based on a de minimis approach, will undoubtedly increase.

Case 3 -- Royersford, PA: Here, NRC again uses this example to assure that "the highest potential doses would be received by farmers working the fields where sludge had been applied. However, potential doses were less than .*. 5 mrem/yr." This is not a scientifically justifiable conclusion; it is based on too small a sample size. Doses to farm workers, nearby residents, or consumers of agricultural produce could very well be substantially higher, particularly if the sludge spread on farm fields contains radioactive materials from multiple sources.

Case 4 -- Oak Ridge, TN: Did the analysis of r i sk from these sludges, which are said to have contained cesium-137, extend over the full hazardous life of the radionuclides? In the instance of spread on deforested land, were inhalation doses from uptake by subsequent vegetation and later release to the atmosphere by burning taken into account? This release pathway for residual radioactivity has been noted in Belarus and Ukraine post-Chernobyl, as it has also with respect to wood ash in this country <Farber and Hodgdon, Health Physics Society, 1991).

Cases 5 and 6 -- Washington, DC, and Cleveland OH: In these instances, urban water was affected, indicative of the potential for contaminations of significance to large populations. A licensee should certainly be required to assume all costs resulting from offsite releases of any of its licensed radio-active material found at a treatment plant or sludge waste disposal facility or on sludge-treated lands, and full liability for clean-up of contaminants under rebuttable presumption, plus all costs of decontamination in such instances.

We urge the Commission to incorporate these positive changes into its Notice of Rulemaking on Disposal of Radioactive Material by Release into Sanitary Sewer Systems. The Commission's goal must be to assure the isolation, not release, of all forms of radioactive waste, not to permit an environmental build-up or "environmental loading" from multiple sources in a succession of small incremental amounts, each of which can be dismissed as merely de minimis.

The best approach is to curtail the generation of more wastes.

Sincerely, jtubffi x11~

Judith H. Johnsrud, Ph.D.

Director, Environmental Coalition on Nuclear Power

Tl~_ ~ '- l\11- l{Sl . 'r t .~ f ~ Radiation Safety Office MDAN)ERSON EnviO ~ f L ~~ ~nd Safet~

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• 94 JUN - 1 P1 :13 OFFICE OF SECR ETAR Y DOCKETING & SERVICE May 18, 1994 BRJ..t,CH Secretary of the Commission U.S. Nuclear Regulatory Commission Washington, DC 20555

SUBJECT:

Advanced Notice of Proposed Rulemaking / Request for Information: Disposal of Radioactive Materials by Release into Sanitary Sewer Systems: FR/Vol.59, No. 38/Friday, February 25, 1994/ 9146-9149.

Dear Mr. Secretary:

Thank you for this opportunity to comment on the above notice.

As a general comment, from the discussion and cases given in the FR Notice, the major reason for considering revising sewer disposal limits appears to be the mere detectability of certain radioisotopes and not to any real or even probable adverse health effects on either STP workers or the general public. This seems to be more and more the standard response of many regulatory agencies.

One of the problems of responding in this way is that any realistic exposure or activity release standards automatically become suspect by the general public or special interest groups. From another angle, it becomes more and more difficult for biomedical Licensees to assure compliance of medical research and clinical staff to even realistic and necessary radiation safety procedures when that staff observes the constant racheting down of radiation regulatory limits below levels that have any scientific meaning.

Concerning the specific subjects listed:

(1) Form of the Material for Disposal --- I am not aware of what effect, if any, sludge bioprocessors would have on reconcentrating radio-labeled buffers/organics commonly used in biomedical research, but I think the NRC should be very skeptical of making regulatory changes because of any theoretical effects. The nature of the vast majority of biomedically used materials disposed of in the sewer system is that upon sewer disposal they almost immediately break down into relatively simple compounds and are readily soluble or dispersible. The activity levels are likely to be very low in any event, even with multiple, localized biomedical institutional releases.

It would be currently be impossible for the University of Texas M.D. Anderson Cancer Center (UTMDACC) to otherwise dispose of our TEXAS MEDICAL CENTER Acknowl ad IIJ \ia.l\J n

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1515 HOLCOMBE BOULEVARD* HOUSTON, TEXAS 77030 * (713) 792-2121 A Comprehensive Cancel" Center Designated by the National Cancer Institute

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There are currently no available commercial disposal options. We are not permitted to incinerate any radioactive material, nor is this likely to occur unless NRC allows current sewer release limits for incineration also. There is not sufficient space available at UTMDACC for storage for decay to background levels (not an option for H-3 or C-14 in any case).

(2) Total Quantity of Material --- In terms of actual biokinetics and health risks for the low levels of radio-labeled materials commonly used in medical research (e.g. H-3, C-14, P-32/33, S-35, Cr-51, I-125, etc.), the three current NRC total quantity limits on releases per year are probably too low. However, as a practical matter, these limits should be retained as they are simple to state, understand and document. In my opinion this is much preferable to individual quantity/concentration/form limits for each radionuclide.

The petitioner's request that all licensees provide at least 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> advance notice to the appropriate sewer treatment plant (STP) before releasing radioactive material to the sewer system is unnecessary and impractical, certainly in terms of biomedical institutions. UTMDACC releases some small amounts of radioactive material to the sewer system on a daily basis. These activities could probably only be detected, if at all, at the STP by expensive continuing on-line sampling and scintillation counting. I cannot see how this would serve any radiation safety purpose.

However, I would support the petitioner's request that the NRC exempt materials that enter the sewer system waste stream from the requirements regarding NRC approval for incineration under current NRC regulations, certainly with regard to those radioisotopes commonly used in biomedical research. Given the radioisotopes and activities involved, the pathways for human exposure from radioactive wastes seem no more or less significant whether the wastes are dispersed in water or air.

(3) Type of Limits --- I think that the most realistic model of exposure from radioactive material released to a sanitary sewer system would be to assume that an individual would always ingest water after the water had passed through the system's STP. Credit should be given to the licensee for any extra water volume this model would provide. From the cases cited there appears to be no significant concentrations of contamination in sewage sludge from radioactive material used in medical research or patients. This is consistent with what one would expect from such radioisotopes and would indicate no significant exposure to STP workers.

I recommend that the NRC not consider a dose limit approach to sewer disposal primarily because the current regulations are

adequate, particularly concerning radioactive material used in medical research or patients. If a dose limit approac~ is considered, it should be based on a calculated dose of 500 mrem/year with all of the terms, methods of calculation and report requirements clearly and realistically defined , particularly for biomedical institutions.

(4) Exemption of Patient Excreta Patient excreta should continue to be exempt from sewer release limits . Again, detectibility by no means equates with either actual or even probable significant personal exposure in terms of patient excreta in the sewer system. Although there has been a significant increase in the number of nuclear medicine diagnostic procedures over the years, the use of radioisotopes with much shorter half-lives have mostly replaced longer half-life radioisotopes previously used.

Any attempt to regulate the release of excreta from patients receiving nuclear medicine diagnosis would be totally impractical.

Holding for decay excreta from hospitalized patients receiving nuclear medicine therapy will definitely increase radiation exposures and contamination incidents involving nurses, nuclear medicine technicians and radiation safety personnel. This was our past experience at UTMDACC.

Sincerely, M. E. Norton Radiation Safety Officer k :\user \ bnorton\o ldbud\ utoeasew.mem

DOCKETED GENZYME CORPORATION USHRC PO BOX 9322 ONE MOUNTAIN ROAD FRAMINGHAM, MA 01707-9322 508-872-8400 May 23, 1994 "94 MAY 31 PS :1 7 FAX 508-872-9080 OFF ICE OF SECRE\AR OCKET NUMBER The Secretary of the Commission DOCKETING & ER /IC ROPOSED RULE PR 20 U.S. Nuclear Regulatory Commission BRANCH Washington, D.C. 20555 (SC/ f /? 91Lf6)

ATTN: Docketing and Service Branch REF: NUREG/CR-5814 We wish to comment on the Advance notice of proposed rulemaking referenced above and published in the Federal Register Vol. 59, No. 38. We support the current limits of total quantity, form and types of limits as listed in 10 CFR part 20. The studies conducted to determine those limits were in our view consistant with good practices in disposal of radioactive materials.

There Is a real concern in our biotechnology industry that reduction in the sewer disposal limits as listed in the current version of 10 CFR part 20 is being considered. Currently, we are dealing with the difficulties in the management of low level radioactive waste (LLW) both within the Commonwealth of Massachusetts and In other states. One of the key elements of reduction of the volume of solid LLW is the conversion at the source of generation of that waste into low levels of water soluable liquid waste. Maintaining the waste as liquid waste which is disposed safely at the site of generation (ex. research laboratory sinks) eliminates many waste management problems and reduces the risk of exposure associated with that material when it would otherwise become absorbed solid waste material. Any significant change in the reasonable limits for sewer disposal would increase the amount of liquid and solid waste and increase risk of exposure associated with the handling of that waste.

We would hope that due consideration will be given to any changes in sewer disposal limits in relationship to the low level radioactive waste Issue as a whole so as not to reduce risks of exposure in one media at the expense of increasing risk in another.

If you have any questions conerning our comments you may call me at (508) 872-8400, Ext. 2150.

Sincerely yours,

---;~~;fir'

~ rdMattila Director of Safety and Laboratory Services (RSO)

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• 94 MAY 31 PS :14 OFF ICE OF SECRETARY DOCKETING & SERV ICE May 26, 1994 BRANCH The Secretary of the Commission Attention: Docketing and Service Branch U.S. Nuclear Regulatory Commission Washington, D.C. 20555

Reference:

Proposed Rule on "Disposal of Radioactive Material by Release into Sanitary Sewer Systems 10 CFR part 20 (RIN 3150 - AE 90)

Dear Sir/Madam:

I believe that the approach of limitation based upon an individual being exposed by the ingestion of water from the sewer outfall (2 liters/day at the point of release) is unrealistically stringent. Insead, the commission should consider other locations such as the sewage treatment plant (STP) or the nearest residential area, in determining the protection to be provided. Incoming sewage~ ~ l d be routinely monitored at some distance from the S e c.u~L'1a. ,Ye..ci.~t Pict""t-- Cfr P ) .

The use of a dose limit approach with total quantity and concentration values in a regulatory guide to facilitate compliance seems most appropriate.

It is my opinion that patient excreta which may contain radioactive materials as a result of nuclear medicine diagnosis or treatment, should be excluded from sewer release limits, because the radioactive materials used in these studies are short lived and decay rapidly, resulting in doses to individuals well below the NRC dose limit for members of the public.

The current regulation is adequate and any radionuclides detected in excreta are usually of very low concentrations. Consequently it is appropriate to continue the exception for patient excereta.

Sincerely, C lv,~ C.':)>t\ i-a. 1-1 h\'l;IA.

Chris Constantinou, Ph.D.

R.S.O.,

NRC License

1. 20 - 12828-01 CC:ec JUL 2 1 19M -.

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Jim Edgar Governor May 26, 1994 Secretary of the Commission U.S. Nuclear Regulatory Commission Washington, D.C. 20555 Attention: Docketing and Service Branch Re: Disposal of Radioactive Material by Release into Sanitary Sewer Systems Gentlemen:

The Illinois Department of Nucl ear Safety (Department} hereby submits its comments on the referenced advanced notice of proposed rulemaking. We were pleased to see that NRC chose to begin discussion on this very sensitive issue in the Advanced Notice of Proposed Rulemaking (ANPR) stage, rather than as a proposed rule. Comments received on the ANPR should assist you in determining the need, or lack of a need, to proceed further.

The first issue you have asked for information and comment on is the form of material allowed for disposal. The Department adopted regulations equivalent to 10 CFR Part 20 allowing only readily soluble or readily dispersible biological material to be released into sanitary sewerage. The Department also recognizes that new sewer treatment technologies are under development, but would caution NRC about developing regul ations to match developmental technologies. There are no guarantees the new technologies will be used, and no evidence that indicates these new technol ogies would result in increased radiation exposure to workers or the public. We think it is prudent for NRC to keep abreast of technological developments, but do not believe additional restrictions on disposal of these wastes should be implemented with no significant evidence of need.

The second issue for comment is the total quantity of material which could be released into sanitary sewers. Departmental staff reviewed NUREG/CR-581 4, "Evaluation of Exposure Pathways to Man From Disposal of Radioactive Materials Into Sanitary Sewer Systems" and found no evidence to support the idea of limiting the total quantity of each radionuclide as mentioned in the ANPR.

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Sanitary Sewer Comments Page 2 The Discussion section of the Federal Register notice summarized the NUREG's modeling scenarios which estimated doses to workers at sewage treatment plants to be from 0.2 to 93 mrem/year. The dose estimate of 93 mrem/year represents an upper bound of doses that could be received assuming all material was released at the 10 CFR Part 20 limits and subsequently reconcentrated. Even the highly unlikely worse-case scenario results in doses less than the current dose limit of 100 mrem/year for members of the public.

We also note that at least five of the six case studies did not result in any actual significant exposures to workers or members of the public. It appears that the few cases that might be of concern could be handled on an ad hoc basis, rather than by rule.

The NUREG also reviewed current industry practice regarding sewer disposal of radionuclides and found that only five radionuclides (Co-60, Sr-90, Cs-137, Ir-192 and Am-241) are of the most concern from a potential public dose perspective. Since NUREG/CR-5814 was completed in 1991 and published in 1992, well before the new 10 CFR Part 20 disposal limits were implemented by licensees, the Department recommends that NRC focus its attention on facilities disposing of Co-60, Sr-90, Cs-137, Ir-192 and Am-241 via sewers. It is possible that these facilities no longer meet the criteria to qualify for sewer disposal and would no longer pose a threat. If this is the case, there is no evidence to support the idea of changing disposal limits at this time.

The second issue for comment also mentions a petition for rulemaking requesting that NRC amend its regulations to require all licensees provide notice to sewage treatment plants 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> prior to release of radioactive material. The Department is concerned that this type of notification could lead to misinterpretation of the transmitted information. What do the sewage treatment plants intend to do with such notification? Would they expect a notification or phone call from every hospital, clinic and nuclear laundry on a daily basis? The Department agrees that licensees must dispose of their wastes in a responsible manner, and disposal records are reviewed during each facility inspection. Requiring licensees to perform an additional notification for a practice currently allowed under the regulations is unnecessary.

The third issue requests comments on the methods for limiting releases to sanitary sewers. Based on the information presented in the NUREG discussed above, the Department sees no need to modify the current approach to limiting releases.

Sanitary Sewer Comments Page 3 The last issue to be addressed concerns the exemption of patient excreta. The Department would like to see NRC continue t his exemption not only because medical procedures typically use radionuclides with short half-lives, but also because requiring hospitals to collect patient excreta would be an extremely costly administrative nightmare, especially for out-patient studies. The only option for hospitals and clinics would be to require patients to collect excreta and either hold it for decay or return it to the licensed facility for decay and disposal. This is obviously unenforceable, and would cause quite a problem for facilities using mobile nuclear medicine services. These facilities might need t o obta*in a license just to handle the waste from patients, which involves significant costs.

Thank you for the opportunity to comment on the Advanced Notice of Proposed Rulemaking. If you have any questions regarding these comments, please contact me or Kathy Allen at (217) 785-9947.

Sincerely,

~~ (!, , (1/4L';:,4.

• Steven C. Collins, Chief Division of Radioactive Materials cc: Jim Lynch, State Agreements Officer

MAY-27-1994 03 : 12 FROM NIRs-w G rp , D, ER To 3015041672 P . 02 pqo o AL E PR 2 o (5&/ FR c;1'-1{J DOCKETED us *~c NIRS.Sewage Sludge Comments to NRC p. l of 3

• 94 MAY 31 A11 :QO

.~* Disposal*of Radioactive Mat~r.ial by Release into*Sanitary Se~ers

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10 CFR Part 29 (RIN 3 IS0-AE90) 5~ t"'. r- c)O' /- J"T p Advance Notice ofProposedRulemaking ( R.1 t-~~~-)Cf l'.i lp May 26, 1994

• The Nuclear Information and Resourc.e Service commented repeatedly and in detail to the Nuclear Regulatory Commission during its rulemaking for 10 CFR 20. One of our major ~ncems remains that for many of the_radionucJides, the allowable concentrations in air and water INCREASE. The new 10 CFR 20 estir.1ates doses in rems EDE, effective dose equivalent. In converting from rems to rems EDE (Effective Dose Equivalent). the estimated or ~culated amount of radioactivity per rem for many of the radionuclides has increased. Despite the NRC's assurances that total risk remains the same or decreases, the reality is that more of many radionuclides may be released into air and water and sewe:rs-. We called upon~~ as we do now to reduce the allowable radioactivhy *released to the e!lvironmen;. *we.also call for limits in verifiable units of measure since rem~ a.nd remi. E~ff ar~ expressioD.3 of.b.iological damage to tissue, based on unverifiable computer models with q~estio.nable assumptions. *-

What justification is there for limiting the publit dose to 100 mllirems a year but then allowing another soe tnillirems pet year on top of.tha from sewage? The EP.A ( 40 CFR 190) limit for public do~si from uranium fuel chain facilities is 25 millirems per year. There is. no justification fQr allowing 500 millirems into sewage. There is no justification for allowing any radioactivity into sewage, for that matter. Radioactivity should be isolated from the environment. The assumption that people don't drink sewage is absurd. What prohibition .o r warning is there on-outfall pipes or on waters downstream of radioactive discharging facilities? Children play in creeks and streams.

People swim and recreate in rivers and waterfalls that easily could be just downstream of discharges. Communities downstream use the water discharged ftom upstream for their drinking water. Dilution does not apply for radioactivity. The total amount of radioactivity and total risk from the discharge rema,ins the same regardless of the dilution rate.

NIRS opposes the use of computer modeling and assumptions about pathways'. It is an art. not a science, in its infancy and fails to protect the public.

The radioactive contamination in sewer b)'St~ms shuulu be prevented. NIRS opposes exempting sewage treatment systems from NRC regulations and demands that the NRC do its job of

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MAY-27-1994 03: 13 FROM NIRS-WASHINGTOr~, DC TO 3015041672 P.03 N1RS,Sewage Sludge Comments to NRC p. 2 of3 preventing the sewage treatment plants from having to fuce the problem, by effectively regulatins its licensees through more vigilant enforcement and stricter standards.

I) Form of the material for disposal Regarding t~c NRC stnndard permitting "the disposal of materials into th.e sanitary sewer if they are soluble*o,r readily dispersibl~ biological materials/ I will simply caution the NRC that the public perception of NRC a.ilowing ground-up 'or pureed radioactive animal carcasses to be poured down the drain is not a positive one. We 'Will comment more substantively on this point if

• this ANPR gets to the PR stage,*
• There is no question that the :NR.C should be considering the pro~essing that both sewage treatmeJJt and water treatment plants use when considering rules permitting-radioactivity in water.

The synergistic effects of different radioactive matetjals and chemical wastes and the chlorine and fluoride .~ water treatment systems should be evaluated.

In addition, water treatment .and sewage treatment plants showd be fully informed about all upstream polluters including federal facilities, commercial (NRC and Agreement state licensees) and non-licensed pol!uters. Exemption information should be routinely provided and kept available for public review. .

At the cost of the polluters, die W{lter-treann:P.t and sewage treatment facilities should be provided v.tith effective monitoring equipment_appropriate for all the types of releases upstream.

2) Total Quantity of Material The commission should co~der total quantities of materials amvmg at the sewage and water treatment facilities from all sources upstream. This should play a role in the linuts placed on individual polluters. For example, if one university has 10,labs each of which is a licensee, each wuld rclcaK the total quantity. If other facilities also discharge into the same sewage system. the sum totals are further multiplied.

The same lack of faith in ~omputer models and c;oncerns about synergism expressed above apply to NRC's suggestion that biokinetics and behavior of each radionuclide are understood well enough to be used to set quantity, fonn and concentration limits.

Risk-- Be forewarned that the public distrusts the NRC assumptions of risk from radiation.

Criticisms of the assumptions in 10 CFR 20 that ignore exposures to children. fetuses, elderly, people with existing body burdens or with other increased risks were made d ~ that rulemalcing and.will ag~n be repeated in this. The risk of birth defects from ionizing radiation exposure was

MAY-27-1994 03:13 FROM NIRS-WASHINGTON,DC TO 3015041672 P.04 NIRS Sewage Sludge Comments to NRC p.3 of3 limit~d to unly 2 geuerntions d~:spite the fact that the grca.tc:st number of birth defects will be seen in generations beyond the next 2. The NRC needs to consider non*cancer and nonfatal cancer health effects which were not considered in the promulgation of 10 CFR 20.

10 CFR 30Js.BRC. The suggestion that "wme MULTIPLE of~ .. the 10 CFR 30" limits be cun5iderc"* fo,* :,ew age r:eleases u.emplifies the kind of abuse of the BRC concept that led

-Congress tq_revoke the.Nl_(.C BRC policies~ * *

3) Type of Limits I was told by the autborJn (thcnew) 10 CFR 20 that NRC assumed that no one would drink sewage which is whythe limit is so high (500 millirems EDE/ yr.).

be There should no release of radioactivity into sewage. But since the NRC already has such a

• high one, it should, at least. be reduced to less than the total allowable dose to a member of the public, since members uf Lht:: public will receive additional dol'!es elsewhere from other unavoidable sources.

In addition .we suggest that all facilities that release radioactivity into water (by exemptiont legal standard' or accidental/higher that legal level) ~e required to provide routine reporting to the public. 00

• Case Studi:.':s: . .=. .

NRC's analysis of case);tudies_should provide an accounting of the financial costs being incw-red to respond to the situation and who is bearing them. A basic tenet of the NRC's policy should be that the full cost of comp!il:lllcc be oome by th~ generator/polluter. -

• We .ask for clarification on how this rulemaking will intersect with the ERROR/ Decommissioning standards being developed by NRC for contaminated sites, with the EPA's rulemakings *on related issues and to federal Superfund (CERCLA) legislation. We suggest public hearings and possibly workshops on this issut: b~fun-i 1i11ali.dng the rule.

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• 94 MAY 31 P5 :07 OFFICE OF SECRETA_RY Mf\Y 2 6 \994 OOCKE TIHG & SE V!CE BRA Hf'tNFORCEMENT

~ FFICEOF DOCKET NUMBER Mr. John C. Hoyle Acting Secretary of the Commission PROPOSED RULE p 20 Nuclear Regulatory Commission (5'1FR 'j/Lf~

Attention: Docketing and Service Branch Washington, DC 20555

Dear Mr. Hoyle:

In accordance with its responsibilities under Section 309 of the Clean Air Act, the U.S. Environmental Protection Agency has reviewed the Nuclear Regulatory Commission's advance notice of proposed rulemaking for 10 CPR Part 20, disposal of radioactive material by release into sanitary sewer systems, published in the Federal Register February 25, 1994, and has no comments.

We appreciate the opportunity to review the proposed rulemaking. If you have any questions, please call me on (202) 260-5053 or have your staff contact Ms. Susan Offerdal (202) 260-5059.

Sincerely, Richard E. Sanderson Director Office of Federal Activities

.JUL 2 1 1994 Acknewledged b card * - - * -

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'94 MAY 31 Al1 :02 L/0 L-94-132 OFFICE Or SECRETARY.

OOCKETl,iG & SE f'IICf Mr. Samuel J. Chilk Secretary of the Commission BRA NC}' DOCKET NUMBER PR 2_ 0 _

U.S. Nuclear Regulatory Commission PROPOSED RULE..:...:.:_

Washington, DC 20555

{$°/ FR '1 14{)

ATTENTION: Docketing and Services Branch

SUBJECT:

Disposal of Radioactive Material by Release into Sanitary Sewer Systems .

59 Fed. Reg. 9146 - February 25, 1994 Request for Comments On February 25, 1994 (59 FR 9146), the Nuclear Regulatory Commission published for public comment an advance notice of propos e d rulemaking (ANPR) titl e d "Disposal of Radi oactive Material by Release into Sanitary Sewer Systems." Notice requests comments that will be utilized by the Commission to determine if there is a need to amend the regulations for release of radionuclides to sanitary sewers from licensed facilities.

Florida Power and Light Company (FPL), as the licensed operator of two nuclear power plant units in Dade County, Florida and two nuclear power plant units in St . Lucie County, Florida, submits the following comments regarding the subject Federal Register Notice.

No changes to the regulations in this area should be considered at this time. A revision to 10 CFR 20 that affects these releases went into effect on January 1, 1994. Also, on January 28, 1994, the NRC issued Information Notice 94-07 on "Solubility Criteria for Liquid Effluent Releases to Sanitary Sewage under the Revised 10 CFR Part 20". It is too early to determine if these changes will have any effect on the form and quantity of radioactive material released to sanitary sewers. FPL believes it is important to determine the effects of the above changes prior to amending the regulations.

The NRC has not demonstrated that further changes to the regulations are required at this time. The contamination incidents described in the ANPR appear to be somewhat isolated and in most cases can be attributed to a single licensee. By the NRC's admission, each case has had negligible effect on the health and safety of the general public. Quantities and concentrations of radionuclides appear to be within current regulatory limits. Radiation exposures to the general public J l 2 1 1994 an FPL Group company cknowl by caret ................ ~**** ~ ...*

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L-94-132 Page Two appear to be within NRC guidelines and limits. Also, the quantities and concentrations of radionuclides at affected facilities appear to be within 10 CFR 30 limits for general licensees. Finally, the NRC has not demonstrated that the revisions described above will not further reduce effluents from licensed facilities.

Prior to making any further revisions to these regulations, the NRC should evaluate the effect the revisions will have on occupational radiation exposures to workers at licensed facilities due to processing, treatment, packaging, and storage of sewage in preparation for disposal. Additionally, the NRC should evaluate the cost/benefit of alternatives to release into sanitary sewers and the impact of the potential burden on low level nuclear waste disposal facilities. Sewage sludge has proven to be very difficult and expensive to process into a form that is acceptable to nuclear disposal sites, while there is negligible added benefit to the general public. Furthermore, several areas of the country do not have access to nuclear disposal sites at this time and would be forced to store the material on site indefinitely.

The following are additional comments regarding the specific questions asked by the NRC in the discussion:

The revised regulations should not take into consideration new technologies for processing sewage. The NRC does not know at this time which, if any, of these technologies will ultimately be used. Neither does the NRC know when any of these technologies will be available or when they are likely to be implemented or installed. Considering the large capital investment in current sewage treatment plants, it is not likely that any of these technologies would see any wide-spread use within the next 10 to 15 years. Therefore, it is too early for serious consideration of new technologies.

It would not be practicable to give a 24-hour advance notification when releasing radioactive material to sanitary sewers. In most cases, releases to sewer systems are continuous and involve very small quantities of radioactive material. In all cases, since releases are small, advance notification would serve no practical purpose and would increase the regulatory burden on licensees. FPL agrees that material released to sanitary sewers should be exempt from requirements for NRC approval for incineration, since the impact on the health and safety of the general public is negligible.

L-94-132 Page Three Limitations on radionuclide releases to sanitary sewers should not be based upon an individual being exposed by the ingestion of water from the sewer outfall. It is unrealistic to consider that any individual would ingest up to 2 liters per day of raw sewage on a continuous basis. Even treated sewage effluent is limited by most local regulations to agricultural use only. Local regulations also prohibit human consumption of sewage effluent within certain distances downstream of an outfall. The NRC should determine a typical downstream distance for human consumption and use this for the basis for estimating individual ingestion exposures.

FPL appreciates the opportunity to comment on this issue.

Very truly yours,

(<\y_T B~ ~\,

-r"'vice President Nuclear Engineering and Licensing WHB/PJS/spt

DOCKETED.

us me RA 94-029 ATS Westinghouse Energy Systems *94 MAY 31 P5~~~gh Pennsylvania 15230-0355 Electric Corporation OFFI CE OF SECRE T RY DOCKE TING & SERVICE May 26, 1994 BRANCH DOCKET NUMBER The Secretary of the Commission U.S. Nuclear Regulatory Commission PAOPOSFD RULE PR 20 Washington, D. C. 20555 (SC/ FR 911-/t)

- Attention: Docketing and Service Branch

Subject:

Disposal Of Radioactive Material by Release Into Sanitary Sewer Systems Gentlemen:

The Westinghouse Electric Corporation appreciates the opportunity to provide comments on the Advanced Notice of Proposed Rulemaking involving disposal of radioactive material by release into sanitary sewer systems. Westinghouse supports the Commission's effort to permit licensees to dispose of radioactive materials by release into public sanitary sewer systems.

The attached comments are presented for consideration by the Commission in this rulemaking proceeding.

Sincerely, A. T. Sabo, Manager Regulatory Affairs db Attachment A TS94-029,{152694 edby d..*_,

JUL_

2 1_1__

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COMMENTS ON ADVANCED NOTICE OF PROPOSED RULEMAKING RELEASE OF RADIOACTIVE MATERIALS INTO SANITARY SEWER SYSTEMS General Comments:

Westinghouse supports the option that radioactive materials can be released into sanitary sewer systems in concentrations listed in Table 3 of Appendix B to 10CFR20 and in accordance with 10CFR20, 20.2003 "Disposal by Release into Sanitary Sewerage." Meeting the criteria in Part 20 should provide adequate protection to the health and safety of the public. Westinghouse is opposed to additional administrative requirements e.g., 24 hour2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> advanced notification to appropriate sewage treatment plants before releasing activity into the system. Until additional information is made available to licensees as indicated in NRC Information Notice 94-07 concerning the study to clarify the mechanisms underlying reconcentration in sanitary sewerage systems, specific changes to Part 20 should be delayed.

Specific Comments:

Westinghouse licensees are concerned with their ability to demonstrate compliance with 10CFR20.2003, "Disposal By Release Into Sanitary Sewerage" section (a) (1) determining solubility. NRC Information Notice 94-07 does address the subject of readily soluble. Both methods presented will be useful to licensees. However, the issue of colloidal forms present in the discharge may not be efficiently removed by the use of filters and/or resin columns.

The question is whether the remaining colloids in the discharge can be classified as soluble or are they to be classified as dispersible. If they are considered dispersible materials, they cannot be released into the sanitary sewer systems since they are not biological materials.

To determine whether contaminated waste water meets the regulatory criteria for discharge into the sewer system, the following methodology is proposed. The waste water after treatment (typically by filtration and ion exchange) would be analyzed in two fractions:

soluble and insoluble. The waste water sample would be separated into two fractions by passing it through a 0.45 J.lm pore size membrane filter. The filtrate would be analyzed using gamma-ray spectroscopy to determine the activity concentration of the soluble fraction. The membrane filter would then be dried and analyzed by gamma spectroscopy to determine the activity concentration of the insoluble fraction. The water would be determined to be acceptable for release into the sewer system provided no significant activity was detected on the filter medium (insoluble fraction), and the sum of the ratios for each radionuclide in the total water sample (soluble and insoluble fraction) to the corresponding sewer release limit does not exceed 1.

A 1594-029,052694

COMMENTS ON ADVANCED NOTICE OF PROPOSED RULEMAKING RELEASE OF RADIOACTIVE MATERIALS INTO SANITARY SEWER SYSTEMS Page Two The revised 10CFR20 does not provide a concentration of a radionuclide in Appendix B for which it can be considered as not present except for DAC's (10%/30% rule). Previously, a radionuclide could be considered as not present provided the concentration of that radionuclide to the applicable MPC was less than .10 and the sum of such ratios for all radionuclides considered as not present in the mixture did not exceed 0.25. For releases to the sanitary sewer, a practical approach would be to consider the radionuclide as not present if the concentration of the radionuclide in the waste water was equal to or less than the effluent concentration limit (10CFR20, Appendix B, Table II, Column 2). The effluent concentration limits are exactly 10% of the sewer release limit. Since this determination would be made without taking credit for dilution from other sources of water from the facility entering into the sanitary sewer, it would be a conservative de minimis level. It is therefore, proposed that the activity concentration on the filter medium (insoluble fraction) would be considered as insignificant if it is less than 10% of the sewer release concentration.

ATS94-029~S2694

OCUON DOCKETED May 25, 1994 USMRC Oculon Co,po,atloo 26 Landsdowne St

• 94 JUN -1 P1 :13 Cambridge, MA 02139 617.621 3141 617.6211434.FAX Secretary of the Commission OFFICE OF SECRETARY US Nuclear Regulatory Commission OOCKETIHG & SERVICE Washington DC 20555 BRAt'\CH Attention: Docketing and Service Branch Gentlemen:

This is in response to the request for comments on the current policy for disposal of radioactive material by release into sanitary sewerage systems. Following is our position on this issue:

( 1) Form of material released:

• The most recent regulations restrict sewerage disposal to materials that are soluble or readily dispersible biological materials. We believe that any prior concerns for concentration of non-biological readily dispersible materials are resolved by the new restriction to biological materials and are unaware of any significant problems with soluble material. We therefore recommend continuation of this allowed release form.

(2) Total quantity of material: Although these unchanged limits easily meet the needs of most licensees, it seems appropriate, given the new restriction on form of material released and the new more restrictive release concentrations, to consider relaxation of these limits for large users since reconcentration should be much less of a concern. It may even be practical to eliminate such an upper cap totally, depending only on concentration restriction with the reduced limits now in effect. We have never seen the logic in applying the same cap to a large program with thousands of users as is applied to a small one with only a few users.

(3) Types of limits: The present method of limitation based on an individual being exposed by ingestion of water from the sewer outfall seems to be sufficiently conservative to satisfy all needs, particularly in view of the new lower release concentrations. This is readily controllable in the workplace and is easily understood for radionuclide users. Proper adherence to concentration limits would appear to negate the need for an upper cap as mentioned in item 2 above.

( 4) Exemption of Patient Excreta: Continuation of this important exemption is encouraged as a significant ALARA consideration. Collection and control of patient excreta would result in the deliberate d..M..?..l J~f. .....

.,.,.,. , - * , *, i V DOCK T,. C 1x cR\11 E SECTION OFFICE OF THE SECRETARY OF THE COMMISSION Document StatistiCS Postmark D:.;te J~6 "/'1 Copies Recerv0d _ ____,=- / _ _ _ __

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OCULON Page 2 reconcentration of a significant waste stream with the potential for worker exposure, spills, and emergency issues that have been avoided through the judicial use of this exemption. The rapid dispersal of this soluble waste stream of short-lived material seems the most practical approach to this issue and we strongly recommend the continuation of the exemption in its current form.

We thank the commission for the opportunity to comment on this important issue and look forward to commenting on any proposed regulations that are forthcoming.

Sincerely, Daniel H. Fisher, Ph.D., C(ASCP)

Senior Bioanalytical Chemist DHF/ru

DOCKET NUMBER PROPOSED RULE PR .,20 (5 CZ F R Cf I'-/ 6 DOCKETED protein ENGINEERING Corporation US NRC

• 94 MAY 31 PS :05 OFF ICE OF SECRETARY DOCK ETING & SERVICE May 24, 1994 BRANCH Secretary of the Commission US Nuclear Regulatory Commission Washington DC 20555 Attention: Docketing and Service Branch Gentlemen:

This is in response to the request for comments on the current policy for disposal of radioactive material by release into sanitary sewerage systems. Protein Engineering Corporation is a small biotechnology company licensed to use radioactive materials for molecular biology research and therapeutic product development.

Following is our position on this issue.

{l) Form of material released: The most recent regulations restrict sewerage disposal to materials that are soluble or readily dispersible biological materials. We believe that any prior concerns for concentration of non-biological readily dispersible materials are resolved by the new restriction to biological materials and are unaware of any significant problems with soluble materials. We therefore recommend continuation of this allowed release form.

(2) Total quantity of material: Although these unchanged limits easily meet the needs of most licensees including Protein Engineering Corporation, it seems appropriate, given the new restriction on form of material released and the new more restrictive release concentrations, to Gonsider relaxation of these limits for large users since reconcentration should be much less of a concern. It may even be practical to eliminate such an upper cap totally, depending only on concentration restrictions with the reduced limits now in effect.

(3) Types of limits: The present method of limitation based on an individual being exposed by ingestion of water from the sewer outfall seems to be sufficiently conservative to satisfy all needs, particularly in view of the new lower release concentrations. This is readily controllable in the workplace and is easily understood for radionuclide users. Proper adherence to concentration limits would appear to negate the need for an upper cap as mentioned in item 2 above.

.JUL 2 1 1994 Acknowledged bf cent-*-**------

765 Concord Avenue Cambridge, MA 02138-1044 TEL 617 868 0 868 FAX 617 868 0 898

.., __ . -'- ~.,,,.. ,.,:::,1v1 L,OCl\t: 11,,u & SERVICE SECTION OFFICE OF THE SECRETARY OF THE COMMISSION Document Statistics Postmari< Date _ 5 /_:;J_,/_...a.-,.._ __

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(4) Exemption of patient excreta: Continuation of this important exemption is encouraged as a significant ALARA consideration.

Collection and control of patient excreta would result in the deliberate reconcentration of a significant waste stream with the potential for worker exposure, spills, and emergency issues that have been avoided through the judicial use of this exemption. The rapid dispersal of this soluble waste stream of short-lived material seems the most practical approach to this issue and we strongly recommend the continuation of the exemption in its current form.

We thank the commission for the opportunity to comment on this important issue and look forward to commenting on any proposed regulations that are forthcoming.

Yours truly, Rachel B. Kent, Ph.D.

Senior Research Scientist and Radiation Safety Officer Protein Engineering Corporation

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• 94 MAY 31 A11 :01 May 24, 1994 Dr. George E. Powers The Secretary of the Commission U.S. Nuclear Regulatory Commission Washington DC 20555 Re: Comments on the Advanced Notice of Proposed Rulemaking regarding Disposal of Radioactive Material by Release into Sanitary Sewer Systems, Federal Register, Vol. 59, No. 38, February 25, 1994, pg 9146-9149.

Dear Dr. Powers:

The NRC is considering changing the existing regulations governing the disposal of radioactive materials into the sanitary sewerage system, in particular 10 CFR Part

20. The following comments are presented to state Hybritech lncorporated's concerns regarding the proposed changes. In general, any proposed change in the regulations should 1) reflect proportionately the level of risk which the proposed regulations are attempting to address and 2) use sound science based upon actual measurements. We are concerned that regulations may be implemented before the true level of risk has been accurately ascertained.

( 1) Comments - Form of Material for Disposal a) Any changes to the current regulations should clarify and define "soluble" and "biologically dispersible" materials. The biotechnology industry uses and manufacturers many biological materials, yet can only respond with difficulty to customer questions about the solubility or biological dispersibility characteristics of our products. NRC Information Notice 94-07 is really not applicable or helpful in answering questions about the many different compounds biomedical companies manufacture, because all compounds are not listed in solubility tables. Also, the analytical methods described in the Information Notice are not applicable to all compounds. An Information Notice more appropriate to the uses of biological compounds in the biomedical business sector would be helpful.

Also, the proposed regulations should expressly provide that "medical diagnostic products in an aqueous mixture" containing less than 10 microcuries of isotope with a half-life of less than 61 days can be poured directly into the sewage system. Because of the sewage system dilution effect on the isotopes, the doses to individuals from this source are far below the NRC's dose limit for members of the public.

Creating a significant difference in human health worldwide Corporate Office 11095 Torreyana Road

• San Diego, CA 92121 * (619) 455-6700
• Fax (619) 453-4124 Mailing Address P.O. Box 269006
• San Diego, CA 92196-9006 ckn wl . -----~

l 1 1994 ,

ft),_,, .)I DOvl\t.1 1,, ~* vU\VlvC:. tCTION OFFICE OF THE SECRET ARY OF THE COMMISSION Ol""UfTl t Statis

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Dr. George E. Powers May 24, 1994 Page Two (2) Comments - Total Quantity of Material b) The current regulations set total annual activity limits for the disposal of these materials into the sewer. This is all that is needed. The nature and extent and the perceived problem, as illustrated in the examples in the Federal Register notice, do not demonstrate any need to place further restrictions of the disposal of radioactive materials.

c) The petition for rulemaking submitted by the Northeast Ohio Regional Sewer District addressing the disposal of radioactive materials into the sanitary sewerage system (PRM-2O-22i would have an adverse impact on the biotechnology industry and those customers using its manufactured products. Medical diagnostic kits used by clinics, hospitals, labs, and universities all over the nation, containing microcuries of activity, are most often flushed down the drain. Notification of the sewage treatment plant every time one of the kit components is released into the sanitary sewage system would require hundreds of phone calls each week. This requirement would be impossible to meet.

To summarize, adding unnecessary restrictions on the disposal of radioactive materials into the sewer, will compromise the industry's ability to work with radioactive materials. Thus, the ability of the biomedical industry to provide adequate diagnostic health care product would be impaired. Unless a significant benefit to public health from such restrictions can be demonstrated, no further burden should be imposed on the manufacturers and providers of medical diagnostic products and services.

We appreciate this opportunity to comment on the advance notice of proposed rulemaking. I am available for any further discussion on Hybritech's comments or other provisions of the notice.

Sincerely, Steve Bursik Assistant Radiation Safety Officer (619) 621-3629

.:,J\>, Hubritech

~, :Jl1NCORPORATEO TEAM EXCELLENCE

oocKETEO US RC BEVERLY HOSPITAL DOCKET NUMBER PR o2-.

PROPOSED RULE~----

( 5 °t FR q 1'-/6)

May 23, 1994 Secretary of the Commission US Nuclear Regulatory Commission Washington, DC 20555 Attention: Docketing and Service Branch Gentlemen:

This is in response to the request for comments on the current policy for disposal of radioactive material by release into sanitary sewerage systems.

Following is our position on this issue:

(1) Form of material released: The most recent regulations restrict sewerage disposal to materials that are soluble or readily dispersible biological materials,. We believe that any prior concerns for concentration of non-biological readily dispersible material are resolved by t he new restriction to biological materials and are unaware of any significant problems with soluble material. We therefore recommend continuation of this allowed release form.

(2) Total quantity of material: Although these unchanged limits easily meet the needs of most licensees, it seems appropriate, given the new restriction on form of material released and the new more restrictive release concentrations, to consider relaxation of these limits for large users since reconcentration should be much less of a concern. It may even be practical to eliminate such an upper cap totally, depending only on concentration restriction with the reduced limits now in effect. We have never seen the logic in applying the same cap to a large program with thousands of users as is applied to a small one with only a few users.

Vt+I\, Member of Voluntary Hospitals of America, Inc.* 'JUL 2 1 1994.

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(3) Types of limits: The present method of limitation based on an individual being exposed by ingestion of water from the sewer outfall seems to be sufficiently conservative to satisfy all needs, particularly in view of the new lower release concentrations. This is readily controllable in the workplace and is easily understood for radionuclide users. Proper adherence to concentration limits would appear to negate the need for an upper cap as mentioned in item 2 above.

(4) Exemption of Patient Excreta: Continuation of this important exemption is encouraged as a significant ALARA consideration. Collection and control of patient excreta would result in the deliberate reconcentration of a significant waste stream with the potential for worker exposure, spills, and emergency issues that have been avoided through the judicial use of this exemption. The rapid dispersal of this soluble waste stream of short-lived material seems the most practical approach to this issue and we strongly recommend the continuation of the exemption in its current form.

We thank the commission for the opportunity to comment on this important issue and look forward to commenting on any proposed regulations that are forthcoming.

Yours truly, James H. Chafey, MD Radiation Safety Officer

DOCKETED USNRC Texas Department. fJI~8'lth3 David R. Smith, M.D. 1100 West 49th Street Carol S. Daniels Commissioner Austin, Texas 78756-llBfcE OF S[CRE lfcpli~ Commissioner for Programs (512) 4ss-11110t t KETltiG & SE V\CE DOC NCH oy L. Hogan Radiation Control BRA Deputy Commissioner for Administration (512) 834-6688 DOCKET NUMBER PROPOSED RULE PR ;2.0 May 20, 1994 (SC/ FR e,ltf6)

The Secretary of the Commission U.S. Nuclear Regulatory Commission Washington, D.C. 20555 Attn: Docketing and Service Branch Re: RIN 3150-AE90

Dear Sir:

Staff members of the Texas Department of Health, Bureau of Radiation Control (Agency) have reviewed the advance notice of proposed rulemaking concerning disposal of radioactive material by release into sanitary sewer systems and offer the following comments for consideration:

It appears that the 1991 prohibition of the disposal of non-soluble, non-biological material via the sanitary sewer would solve each of the case studies provided. As such, no further rulemaking would seem necessary. Also, unless pathway modeling can demonstrate that exposures other than ingestion can exceed the 500 millirem per year standard, there seems little reason to create any additional restrictions.

The concept of creating a quantity limit for each radionuclide may create many problems for licensees.

A quantity limit for each radionuclide could create a "bookkeeping nightmare" for large research and development licensees (e.g., universities) because such licensees would have to keep track of releases of each radionuclide to ensure that no single quantity limit was exceeded, rather than the total quantity limit.

However, it may be reasonable to divide the one curie per year limit for all other isotopes into two limits based on the half-life of the isotopes. Long-lived isotopes that might concentrate in sludge could be held to a lower annual limit. A suggestion would be to keep the one curie per year limit for isotopes with half-lives of less than one year and 100 millicuries per year for isotopes with a half-life of greater than one year.

The concept of requiring a licensee to provide notice prior to any release via the sanitary sewer is unworkable. Many universities have laboratories that might be disposing of minimal quantities of radioactive material via the sanitary sewer. Since the disposal limits are based on meeting certain radiological safety criteria, any further notification requirements would serve no purpose in terms of additional radiation safety.

Thank you for the opportunity to provide input. If you have any questions concerning the comments, please contact Mrs. Ruth E. McBurney, C.H.P., Director, Division of Licensing, Registration and Standards at (512) 834-6688.

Sincerely, ~

. fl, '

"chard A. Ratliff, P.E.::i:.r Bureau of Radiation Control An Equal Employment Opportunity Employer L 2 1 1994 by

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-:. tation Support Department DOCKETED PECO ENERGY US NRC PECO Energy Company Nuclear Group Headqu arters 965 Chesterbrook Boulevard Nayne, PA 19087-5691

• 94 MAY 31 P5 :18 OFF ICE OF SELRETARY May 19, 1994 DOCKETING & SERVICE BRA1~CH DOCKET NUMBER PR 2 0 F-ROPOSED RULE___,;_._ __

Mr. Samuel J. Chilk (59FR qJ'-16)

Secretary of the Commission U.S. Nuclear Regulatory Commission Attn: Docketing and Service Branch

• Washington, DC 20555

Subject:

PECO Energy Company Comments Concerning NRC Advance Notice of Proposed Rulemaking 1o CFR 20, "Disposal of Radioactive Material by Release into Sanitary Sewer Systems" (59FR9146)

Dear Mr. Chilk:

This letter is being submitted in response to the NRC's request for comments concerning the Advance Notice of Proposed Rulemaking (ANPR) 1o CFR 20, "Disposal of Radioactive Material by Release into Sanitary Sewer Systems," published in the Federal Register (i.e., 59FR9146, dated February 25, 1994). PECO Energy Company appreciates the opportunity to comment on this ANPR to determine whether an amendment to the NRC's regulations is necessary governing the release of radionuclides from licensed nuclear power facilities to sanitary sewer systems.

This potential rulemaking effort would revise the approach to limiting the release of radioactive materials into sanitary sewer systems by licensed nuclear power facilities based on current sewer treatment technologies. PECO Energy offers the following comments regarding this ANPR and recommends that the NRC not proceed at this time with any rulemaking to amend the current regulations concerning the release of radioactive material into sanitary sewer systems.

Comments

1) In the "Discussion" section of this ANPR, the NRC indicates that a number of incidents have occurred whereby radioactive material contamination was Identified in sanitary sewer sludge and that these cases occurred prior to implementation of revised 1o CFR 20 limits for controlling the release of radioactive material to sewer systems. In response to these incidents the NRC revised its regulations in May 1991, to allow readily dispersible biological material to be released, but prohibited the release of any non-biological insoluble material since insoluble materials were generally implicated in the sewer sludge contamination cases. In addition, concentrations for some radionuclides permitted to be released to sewers were reduced by a factor of ten (10) as part of an overall reduction in effluent release limits. Since none of the cited cases occurred after the NRC amended its regulations in May 1991, it AcknoWI ed , JUL 2 1 19'4 card-.......................... ~

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• Page 2 is difficult to ascertain whether or not the current regulations have been effective in preventing recurrence. Unless the current regulations are proven ineffective, we do not consider it necessary or desirable at this time to Initiate a rulemaklng to amend the regulations governing the disposal of radioactive material Into sanitary sewer systems.

2) In response to Item (2), "Total Quantity of Material," in the "Request for Information and Comment* section of this ANPR, we recommend that the NRC consider risk-based release limitations on dose in determining the maximum allowable activities for specific radlonuclldes. Using this methodology would eliminate the need to require that a 24-hour advance notice be made to the applicable sewage treatment plant prior to releasing radioactive material to the sanitary sewage system. Requiring a 24-hour advance notice as Indicated In Item (2) will result In an undue administrative burden for licensees, which should not be Incurred without equal benefit (I.e., Increasing the level of protection to ensure the health and safety to the public). If the limits stipulated in the existing regulations maintain doses to the public at or below a pre-determined level (I.e.,

such as the existing dose limits for a member of the public from other release pathways) n As Low As Reasonably Achievable (ALARA), a 24-hour advance notification would not be necessary.

If you have any questions, please do not hesitate to contact us.

Very truly yours, y -t? ?I~,#U /(

G. A. Hunger, Jr.

Director Licensing Section

DOCKET NUMBER PR ~

PROPOSED RULE ;2.. O

( fq F f< qJ'{~ May 16, 1 KETED SHRC Samuel J. Chilk The Secretary of the Commission *94 HAY 31 PS :06 United States Nudear Regulatory Commission Washington, DC 20555 Attention: Docketing and Service Branch OFFICE Of SECRETARY OOCKETlNG & SERVICE RE: Comments on Proposed Change to 10CFR20 BRANCH Disposal of Radioactive Material into Sanitary Sewer Systems

References:

Advance Notice of Proposed Rule Making in Federal Register Vol. 59, No. 38, Page 9146 (BIN 3150-AE90}

NUREG/CR-5814, Evaluation of Exposure Pathways to Man from Disposal of Radioactive Materials into Sanitary Sewer Systems

Dear Secretary Chilk:

The February 25, 1994, Federal Register announced advance notice of proposed rulemaking related to the disposal of radioactive materials to sanitary sewers.

The FR asked for comment from interested parties; we offer these comments for consideration.

I am concerned that the Commission may significantly reduce the limits in Part 20.2003--Disposal by release into sanitary sewerage. I believe that, in many cases, sewer disposal of these materials results in the lowest reasonably achievable dose.

My concern with the notice of proposed rulemaking is that lower, perhaps much lower, numerical limits will be adopted into Part 20.2003. Agreement states will comply and some may further reduce these limits. Lowering the limits could place a significant burden on us; a burden that can not be justified if the ALARA concept is inducted.

If it is decided that the numerical limits (10CFR20.2003(a}(4)) are not providing adequate protection from radiation for workers or members of the general population, I suggest that the Commission consider extending the dose calculation concepts in Part 20.1203, Part 20.1204, and 10CFRS0-Appendix I to the sewer disposal of radioactive materials. A simplified version of Regulatory Guide 1.111 could be developed to aid licenses and regulators to project and to demonstrate that routine releases comply with the dose limits of 10CFR20.

If I can be of further assistance please contact me at (510} 643-7976. Thank you for your considering this request.

Sincerely, pl:d(:;/,

565-35 Lori Drive Benicia, CA 94510 J L 2 1 1994 d...................................

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.&===== Reply to:

Committee on Radiation and the Environment Secretary of the Commission United States Nuclear Regulatory Commission Washington, D.C. 20555 gOCKE.T NUMBER po 2()

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PROPOSED RULE..!..!!

To the Secretary: (5Cf-FR q1LJ~

The Committee on Radiation and the Environment o f the Pennsylvania Chapter of Sierra Club submits these comments on the Commission ' s Notice of Proposed Rulemaking, entitled Disposal of Radioactive Material by Release in Sanitarv Sewage Systems, published for comment in the Federal Register, February 25 1 1994. at 59 FR 9146-9.

We join with the thrust of comments from the Environmental Coalition on Nuclear Power on the need for more stringent control of radioactive materials that have in the past been permitted to be released to the environment through sewage and the landfilling or landspreading of sewage sludge.

We support strongly the Commission's Proposed intent to restrict and reduce the release and reconcentration of radioactive materials through sewage, sewage treatment and disposal. We e9ually strongly oppose any regulatory actions that would allow licensees

• economic considerations to override NRC ' s provision of maximum protection for public health and safetv.

Measurement of contaminants should be taken at the point where maximum concentration occurs, and permissible limits should be based upon the worst case exposure scenarios in order to provide some amount of conservatism. Point of release from a licensed facilitv to the water body ties the release to its source and records its highest concentration. By contrast, at the point of intake, dilution will have occurred and other radioactive discharges may confound the measurements, clouding the regulator ' s abilitv to trace a radio-active contamination ta its proper source.

Our Chapter, representing an area with many nuclear industry licensees, is concerned that releases of technologically-produced radionuclides int the environment be held to the lowest possible levels, and that licensees are held accountable for their activ1ties 1 as Pennsylvania state law endeavors to do with a rebuttable presumption of responsibility for contamination in the vic1~itv fa l o w-level radioactive waste disposal facilitv (a mechanism for regulatory control we would commend to the Commission). All NRC licensees ha ve a resp nsibilit v to i~corP rate fully into their costs of doing business all costs associated with the 9eneration or uses of radioactive materials and

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With respect to the questions posed for comment:

1. Forms of material for disposal -- The NRC should impose any and all restrictions necessary to minimize the amounts of radioactive materials that are released into the environment by way of sewage treatment and disposal.

2. Total 9uantity of material -- We recommend that the NRC eliminate the exemptions of radioactive materials now allowed. The combination of approaches to total 9uantity limit that will result in the least possible release to the biosystem should be adopted in order to minimize also exposure to individuals.

The Commission should not use comparative risk assessments or "acceptable risk" analyses in ways that would permit any increases in the potential levels of dose to the public in order to accommodate an alleged economic or regulatory burden of licensees. Advance licensee notification to the sewage treatment facility should be re9uired by the NRC.

3. Types of limits -- Protection of the public health would be increased through a system of layered monitoring. The permissible limit at the outfall should certainly be no greater than the permissible limit (now 100 mrem/yrl total effective dose e9uivalent, not 500 mrem/yr. A licensee should include this pathway in its overall TEDE dose calculations. A second layer of monitor-ing at a treatment facility is advisable, especially where there may be multiple sources of release. A third layer of public health protection should be provided at the potable water intake to assure that the ingestion dose finally received lies well below the maximum drinking water standard.

The best way of reducing sewage sludge contamination is to remove the exemptions for radioactive materials in sewage and sludge and re9uire isolation in licensed secure storage and disposal facilities. The dose limits should conform to standards that provide maximum levels of protection for the public.

4. Exemption of patient excreta -- For medical uses of radioisotopes for diagnosis and treatment, we urge the Commission to establish regulatory control of this source of radioactivity in sewage and resultant sludge. The uses of nuclear medicine have expanded over the years, adding to the overall contribu-tions of radioactive materials and wastes entering the biosphere, as the Commission here recognizes. Since we recommend that the NRC use its regulatory a.uthori ty to minimize "manmade" increases of radiation in the environment, i'-le urge that this exemption be withdrawn. Because, as the NRC notes, most medical sources are relatively short-lived, the added burden of storage to decay would not be undue for the licensee.

Spaulding Rehabilitation Hos~ital 125 Nashua Street, Boston, Massachusetts 02114 OOCKER{o Telephone: 617-720-6765 Fax Number: 617-720-6834 USN Harvard Medical School Department of Clinical Laboratories *94 MAY 31 1\10 :57 Teresita S. Valdez, B.Sc., M.T. (ASCP), Dip. Bae!.

Director Carl A. Hirsch, M.D.

Medical Director OFFICE OF SECRETARY Consultant Pathologist OOCKETlt~ ~ & SERVICE BR Atkrl May 24, 1994 DOCKET NUMBEA ,

PROPOSED RULE PR 2 0 Secretary Q/" the Commission (S°t FR 9/Lf{J U.S. Nuclear Regulatory Commission Washington, D. C. 20555 Attention: Docketing and Service Branch

Dear Sir/Madam,

Thank you for the opportunity to comment on this important issue. As a representative of the Immunoassay Laboratory at the Spaulding Rehabilitation Hospital, I strongly recommend the continuation of the exemption in its current form. Our judicious use of low level radioactive isotopes, in the form of test kits for invitro-testing, is very carefully monitored. However, realizing the vast number of users of radioactive material and consequential results, I hope the development ql new technologies for sewer treatment, currently under development, will be implemented in the not too distant future. It seems the most complete way to finalize radiation safety. The process that eliminates radioactive by-products more completely would seem preferable.

Thank you again for this opportunity to comment. We look forward to commenting on any proposed regulations that are forthcoming.

Sincerely, Anna Newberg, M. T. (ASCP)

Immunoassay Laboratory cc: Frank Masse, Consultant Radiation Safety Committee Teresita S. Valdez, Director Clinical Laboratories "JUl211 Spaulding is a major affiliate of The Massachusetts General Hospital. The hospital is a private not-for-profit rehabilitation center associated with Harvard Medical School and Tufts University School of Medicine. It offers rehabilitation care in the fields of neurological disease, orthopaedics, fracture, stroke, arthritis, pediatrics, pain, traumatic head injury, spinal cord disease, amputation, oncology, alcoholism, cardiology, pulmonary disease, dialysis, and other rehabilitation specialties.

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Medical Center OFFICE O. SE ETAR OOCKETl,'G* *1ruSEP.V!CF B ,I\, ..,7 May 23, 1994 Secretary of the Commission U.S. Nuclear Regulatory Commission Washington, D.C. 20555 Attn: Docketing and Service Branch Gentlemen:

This is in response to your request for comments on the current policy regarding the disposal of radioactive materials by release into sanitary sewerage systems. Our position is described below:

(1) Form of Materials Released:

We feel that the new regulation restricting sewerage disposal to materials that are soluble or readily dis-persible biological materials have resolved the issue of concentration of materials and therefore recommend the continuation of this policy.

(2) Total Quality of Material:

While the current limits appear easily attainable by most licenses the new restrictions on the forms of materials released and on the release concentrations should reduce the concern over reconcentration of materials, and so seems reasonable to consider easing release limits for large users.

(3) Types of Limits:

The present method of limiting releases into sanitary sewerage systems seems adequate, especially when the new reduced release concentration limits are considered.

Hope Avenue Waltham. MA 02254-9116

'Telephone (617)-647-6000 Tolecopier (FAX) {617)-64 7-6007 ..............

DOCKE SER~1CE SECTION OFFICE OF THE SECRETARY OF THE COMMISSION Statlstks Postm

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Secretary of the Commission May 23, 1994

( 4) Exemption of Patient Excreta:

The discontinuation of this exemption would negatively impact the ALARA programs of licensees. The collection of excreta would result in a reconcentration of a large volume of waste. This would result in a significant increase in worker exposure and an increased risk of spills due to incorrect handling. This water soluble waste has a rapid dispersal rate and consists primarily of short lived nuclides. The most practical approach to disposal would be the continuation of the current exemption.

Thank you for the opportunity to comment on these issues.

Sincerely, 2 :ft(~-fit~

Chief of Radiology &

Radiation Safety Officer WalthamWeston Hospital & Medical Center

~~t~

Steven Levitsky, Executive Vice President WalthamWeston Hospital & Medical Center N.R.C. License: 20-13486-01

/sck cc: F.X. Masse & Associates File

DOCKET NUMBER PR PROPOSED RULE 20 DOCKETED (SC, FR <:j/L/6)

BRIGHAM HaMrd )J~~~-chool Frank P. Castronovo, Jr., Ph.D.

~

Din>ctor, Department of Health f'hy 1cs AND and Radiopharmaco/ogy Radiation Safety Officer WOMEN'S HOSPITAL Radiopham1.ic1st I Radiopharmaw/ogi,t OFFI CE Of SECRETARY OOCKETIHG & SERVICE 75 Francis 5treet BRANCH Bo ton, Ma,sachusetts 02115 (617)732- 057 FAX. (617)566--9>74 May 20, 1994 The Secretary of the Commission U.S. Nuclear Regulatory Commission Docketing and Service Branch Washington, D.C. 20555 Re: Proposed rule making RE:

Disposal of Radioactive Material into Sanitary Sewage Systems To Whom It May Concern:

My position at the Brigham and Women's Hospital, a large NRC Broad Licensed medical/research facility, is that of Radiation Safety Officer. The thought of losing the option for disposing of allowed concentrations of radionuclides into the sanitary sewage disposal is most disturbing. I believe sewage disposal of water soluble radioactive material is Al.ARA, especially when it pertains to radiocontaminated patient excreta. The administration of 1-131 as sodium iodide to individuals with metastatic thyroid cancer is a common treatment. A typical patient receives 100 mCi's of this radionuclide and approximately 50% of this dose is excreted in the urine within 18 hours2.083333e-4 days <br />0.005 hours <br />2.97619e-5 weeks <br />6.849e-6 months <br />. Presently the patient is allowed to excrete into the toilet when needed. If collection of this excreta was required serious exposure potential would exist on the health care unit. The gamma-factor for 1-131 is 2.2R/hr/mCi at 1 cm. Fifty mCi's of 1-131 contained within a collection urinal would conservatively read 220 R/hr/50 mCi's at 1 cm, 236.8 mR/hr at 30.48 cm, and 22 mR/hr at 100 cm. This exposure is totally unnecessary when sewage disposal exists.

The total water usage for the Brigham and Women's Hospital is 390,924.3 gallons per day, or 1,479,648,475.5 mis during this time period. For a 100 mCi patient where 90%

of the 1-131 administered is excreted into the sewage system during a 24 hour2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> period with no decay correction, the average concentration of 1-131 leaving the complex is 0.00006 microCi per ml of sewage water. This translates to 0.049 microCi per ml of storage water per minute, assuming 50 mCi is excreted at one time, which is highly unlikely.

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The Secretary of the Commission U.S. Nuclear Regulatory Commission May 20, 1994 Page Two In diagnostic nuclear medicine at our institution an average of 9 bone scans are performed daily at 25 mCi per study. Assuming 50% of the administered dose is excreted with the urine, then 112.5 mCi per day finds its way into the sanitary sewage system. This translates into 0.000076 microCi per ml sewage/day when not correcting for decay. If collection of this urine was required, universal precautions, lack of adequate space and unnecessary radiation exposure would present an unhealthy atmospher-e for nuclear medicine personnel.

• Research disposal via approved sinks is based on 10CFR20, Appendix C values. This approach resulted in a total of 188,741 .38 microCi in 1993. On a per month basis, assuming a uniform disposal logistic, the radioactivity concentration disposed equals 0.000000354 microCi/ml sewage.

It is quite apparent from the above discussion that the present sanitary sewage disposal release of radioactive material is environmentally adequate. Without the present regulatory allowances unnecessary exposure to radioactivity as well as to viral/bacterial contamination would result. In addition, the necessity to construct "shielded store rooms" on the clinical care unit and within Nuclear Medicine would result in increased health care costs.

Sincerely, Frank P. Castronovo, Jr., PhD Director, Health Physics & Radiopharmacology FPC/rac cc: NRG File B. Leonard Holman, M.D.

J. Gaida nrc.3

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• 94 MAY 27 P3 :55

( fC/ Fr<. C, /L-/6)

May 25, 1994 OFF ICE OF SECRETAR OOCKETI G & SERVICE BRANCH Mr. Samuel J. Chilk Secretary of the Commission U.S. Nuclear Regulatory Commission Washington, DC 20555

- ATTN: Docketing and Service Branch

Dear Secretary Chilk:

This letter is submitted in response to the Federal Register notice of February 25, 1994 (59 FR 9146) regarding 10 CFR Part 20: Disposal of Radioactive Material by Release into Sanitary Sewer Systems.

New York State believes a rulemaking in this area is necessary and we support it. We have experience with sanitary sewer and treatment plant contamination and, therefore, feel the approach to regulating discharges should be re-evaluated in light of changes in the treatment technologies.

However, New York also feels there is a need for further examination of the various issues involved in this area. More information should be collected and offered for public review and comment. Furthermore, we feel that when a rulemaking is undertaken, an Environmental Impact Statement (EIS) should be done in support of it, pursuant to the National Environmental Policy Act of 1969 (NEPA).

More detailed comments on the NRC's advance notice of the proposed rulemaking are attached.

The comments represent the effort and views of the New York State Departments of Environmental Conservation and Labor.

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New York State Department of Environmental Conservation Division of Hazardous Substances Bureau of Radiation Comments on the U.S. Nuclear Regulatory Commission's February 25, 1994 Advance Notice of Proposed Rulemaking on Disposal of Radioactive Material by Release into Sanitary Sewer Systems May 5, 1994 General Comments

1. In the summary to the Advance Notice of Proposed Rulemaking (ANPR), the NRC asks for information to determine whether or not the regulations governing the release of radioactive material to sanitary sewers should be amended. The Department of Environmental Conservation recommends that the NRC revise the regulations. We also urge the NRC to prepare a full environmental impact statement (EIS), pursuant to the National Environmental Protection Act (NEPA), on the rulemaking. The current regulations on sewer releases, even the provisions adopted a s recently as 1991, have never had the benefit of a full environmental review. The NEPA environmental impact statement process provides the mechanism for a complete evaluation of reasonable alternatives, full public participation, and documentation of the rationale behind the final regulations adopted.

2. If the NRC decides to amend the sewer disposal regulations, the Notice of Proposed Rulemaking should announce, for public comment, the compatibility category the NRC intends to apply to each provision. Agreement States are still in the position of being required to have in place regulations compatible with the new 10 CFR Part 20 without the NRC having determined the compatibility requirements. This must not happen again. In addition, publishing the proposed compatibility category for comment will allow Agreement States and other interested parties to participate in the decision on compatibility.

3. NRC should address (either in the rulemaking or in a regulatory guide) the issue of monitoring for materials prohibited from discharge to sanitary sewers. In some situations, it may be impossible to prevent the introduction of traces of insoluble radioactive material into wastewater. In that case, a lower limit of detection for the monitoring system must be determined. Guidance on setting the LLD is needed. (DEC has requested technical assistance from NRC on this issue.)

Page 1 of 4

The following are our responses to the items under Request for Information and Comment in the ANPR:

1. Form of the Material for Disposal The regulations should definitely take into account the new sewage treatment technologies being developed. DEC agrees that the effect of these technologies on radionuclide solubilities should be investigated. Another question that should be investigated is how the solubility of radioactive material may change in the sewer itself. Wastewater that enters a sewer downstream from the point of discharge of radioactive material can change the pH or other characteristics of the sewage, which can then affect the solubility of the radioactive material in the sewage. Such changes within the sewer can lead to deposition of radioactive material in the sewer itself, before the radioactive material reaches the sewage treatment plant.

2. Total Quantity of Material The total quantity (or activity) limits should be re-examined. Limits specific to each radionuclide would be more complicated, but could be more effective in preventing contamination and exposures. Any new limits on total activity should be based, in part, on the biokinetics and health risk for each radionuclide. However, expressing the activity limit in terms of the ALI (or some other quantity based on dose assessments) would not necessarily account for the effects of the sewage treatment process. After sewage treatment, the chemical form and concentration of a radionuclide may be significantly different than what was originally discharged to the sewer. The ingestion pathway may no longer be the most significant source of radiation dose. Or, if ingestion is still the primary pathway, changes in radionuclide concentration or chemical changes could affect the fate of the radionuclides in the body.

The NRC invites comments on the option of setting a total activity limit based on the specific sewage treatment processes involved and the other discharges of radioactive material to the same STP. This could be a more effective approach; however, it would be a major change in the way discharges to sewers are regulated. Such a regulatory scheme may require that a regulatory agency determine the maximum annual quantity that a particular STP could receive. There may then need to be a system for allocating that total activity among all the licensees discharging to that sewer system. This is similar to allocating the waste assimilative capacity of a waterway, which raises many questions of fairness, priority, and grandfathering. Page 2 of 4

Setting system-specific activity limits would probably require that licensees obtain approval in advance for the discharges of radioactivity, increasing costs for both licensees and regulatory agencies. Agencies would have to keep track of the total discharges to the STP and any changes in the treatment process. An alternative to this approach is to set activity limits so low that no matter what the treatment process or the number of dischargers, the limits or ALARA goals for doses to the public are not exceeded. This would not require as much regulatory oversight. These and other reasonable alternatives should be evaluated in the EIS for this rulemaking. The petition for rulemaking by the Northeast Ohio Regional Sewer District (NORSD) requests that licensees provide notice 24 hours in advance of discharging radioactive material to the sewer. This request should be evaluated after new limits are set for sewer discharges, because only then can the usefulness of such a notice be assessed. For example, if sewer discharge limits are to be lowered to a point where the chance for reconcentration in any STP is remote, there would be little justification for advance notice. On the other hand, if the total quantity limit is to be set based on the specific treatment plant, its processes, and its capacity, then notice to the STP may be justified to keep track of the total quantities discharged. The NORSD requested that the incineration of radioactive material discharged to sanitary sewers be exempt from NRC regulations on incineration of radioactive material. This raises important questions about the regulatory status of radioactive material disposed of to the sewer. In the contamination of the STP in Tonawanda, New York, the State of New York did not pursue an enforcement action against the Town of Tonawanda for incinerating radioactive material without the approval of the Department of Environmental Conservation. If release to the sanitary sewer system is to be considered disposal, the limits should be set so that after the release to the sanitary sewer, no further regulation of the radioactive material is needed. Otherwise, STPs would be forced to handle regulated material when, it could be argued, they have no authority (under the Atomic Energy Act) to limit or restrict discharge of the material to their system.

3. Type of Limits NRC should reconsider the approach of limiting the discharge of radioactive material based on the dose to a person who ingests the STP effluent. Instead, all exposure pathways should be evaluated, and the pathway(s) most likely to deliver the highest dose should govern the dose considerations. If more realistic Page 3 of 4

scenarios were used for the pathway analyses and dose assessments, the reference dose should be reduced from 500 mrem to a more realistic number. The new reference dose should take into account the possibility of other exposures to the same individual. While all reasonable dose scenarios should be evaluated, the potential dose should not be the only factor considered in setting sewer discharge limits. The contamination of a sewer or sewage treatment plant may actually result in an insignificant dose to workers and the public, but it may have tremendous costs in time and expense spent for decontamination. The goal of the limits should be twofold: to keep doses ALARA and prevent the contamination of sewers, STPs, receiving waters, and sludge and ash disposal sites. These two goals and the alternatives for achieving them should be evaluated in an EIS. The NRC requests comments on the alternative of expressing the discharge limit in terms of a dose limit (instead of in activities and/or concentrations). This would be more complicated to implement. It would require more regulatory oversight and perhaps require licensees to obtain prior approval for sewer discharges. These alternatives should be evaluated in the EIS for the rulemaking.

4. Exemption of Patient Excreta At this time, we do not support rescinding the exemption for patient excreta. These wastes present not only biohazards, but also a real risk of contamination and exposure to workers and the public if the wastes must be collected and monitored before disposal. However, this exemption has been in effect for many years, without reevaluation. In this ANPR, the NRC has identified changing the exemption as a rulemaking alternative.

Therefore, the issue should be fully evaluated in an EIS. The EIS should not address only the question of whether or not the exemption should be retained. Rather, a range of reasonable alternatives for modifying the exemption should be assessed. If the final decision is to retain the exemption, the EIS will provide a long-needed record of the rationale for the decision and the expected environmental and public health impacts. C:\ TH I SMO\APNRSEWR Page 4 of 4

NYSDOL COMMENTS ON THE USNRC's ADVANCED NOTICE OF PROPOSED RULEMAKING REGARDING DISCHARGE OF RADIOACTIVE MATERIALS TO SANITARY SEWER SYSTEMS The longstanding practice of allowing discharge of radioactive materials to sanitary sewer systems, under regulations that established both concentration limits and annual activity caps, counted on dilution and dispersion to further reduce concentrations. However, these regulations pre-dated modern sewage treatment processes, and incidents involving re-concentration of nuclides began to occur regularly. The changes to 10 CFR Part 20, which took effect in 1991, reduced concentration limits and limited sewage discharge almost exclusively to soluble materials. The solubility requirement was a logical "quick fix" since insoluble materials were the cause of most incidents, but no basic changes were made in the analytical approach used. A NUREG which was issued after the Part 20 revision, modeled individual exposures based on reasonable scenarios but started with the Part 20 limits and used very conservative assumptions. It would have been more logical to reverse this process (derive concentration and total activity limits starting with individual dose goals) and to have used the results as the revised Part 20 limits. The NRC "notice" states that NRC has now contracted for a study to evaluate the effects of sewage treatment methods on the solubility of radioactive materials. It is further stated that the outcome of the study could result in rule changes regarding the forms of radioactive material suitable for sewage disposal. NRC raises a number of other issues in this notice, such as: whether it should continue to use an annual activity limit, or specify annual limits for each nuclide; whether it should continue the analytical approach of assuming individuals ingest water at the sewage outfall; whether it should evaluate exposure from sewage sludge; and whether excreta from patients undergoing diagnosis or treatment with radiopharmaceuticals should continue to be excluded from regulation. Except for the patient excreta exclusion, all of these issues require more technical data on which to base a decision. Collecting the excreta of patients undergoing diagnosis would involve an expense and worker biohazard out of all proportion to the radioactivity involved. It would also be impossible to accomplish for outpatients, who make up a large proportion of this patient population. Collecting excreta from therapy patients presents both a biohazard and radiation hazard to workers, that dwarfs any individual exposure scenario that could be applied to sewage discharge. NRC should await the results of the current study it has contracted for, and should consider what further data is needed to support decision-making on these issues. It should then publish

this information for review and comment. The types of regulatory changes being proposed would greatly complicate procedures and recordkeeping for licensees, and the review of these procedures and records by regulatory agencies. They should not be undertaken without a firm data base. It would have been preferable for NRC to undertake this review before it revised the sewage discharge limits in 1991. Apart from the additional burdens that are imposed in almost all rulemakings, making sequential changes in the same regulation is in itself a burden for regulated parties. NRC should ensure that any changes eventually judged to be necessary based on data obtained, are made in a consolidated fashion and not piecemeal.

DOCKET NUMBER PR ,..,0 PROPOSED RULE..:....=..:::._~- -- DOCKETED UStJRC Carl f " 5)111uhtro m II. Ch<1inna11 (_5't FR '11'16) Pl't(' I' A . Cha1nJ1w1. Pn*.\ ident

                                                                                                                 *94 HAY 27 P3 :19 May 23, 1994 OFFI CE OF SECRETARY DOCKE T! 4G & ~ERVICE BRA NCH Secretary of the Conmission US Nuclear Regulatory Conmission Washington, DC   20555 Gentlemen:

This is in response to the request for ccmnents on the current policy for disposal of radioactive material by release into sanitary sewerage systems. Following is our position on this issue: (1) Fenn of material released: The most recent regulations restrict sewerage disposal to materials that are soluble or readily dispersible biological materials. We believe that any prior concerns for concentration of non-biological readily dispersible materials are resolved by the new restriction to biological materials and are unaware of any significant problems with soluble material. We therefore reccmnend continuation of this allowed release fonn. (2) Total quantity of material: Although these unchanged limits easily meet the needs of most licensees, it seems appropriate, given the new restriction on fonn of material released and the more restrictive release concentrations, to consider relaxation of these limits for large users since reconcentration should be much less of a concern. It may even be practical to eliminate such an upper cap totally, depending only on concentration restriction with the reduced limits now in effect. We have never seen the logic in applying the same cap to a large program with thousands of users as applied to a small one with only a few users. (3) Types of limits: The present method of limitation based on an individual being exposed by ingestion of water from the sewer outfall seems to be sufficiently conservative to satisfy all needs, particularly in view of the new lower release concentrations. This is readily controllable in the workplace and is easily understood for radionuclide users. Proper adherence to concentration limits would appear to negate the need for an upper cap as mentioned in item 2 above. (4) Exemption of Patient Excreta: Continuation of this important exemption is encouraged as a significant AI.ARA consideration. Collection and control of patient excreta would result in the deliberate reconcentration of the significant waste stream with the potential for worker exposure, spills, and emergency issues that have been avoided through the judicial use of this exemption. The rapid dispersal of this soluble waste stream of short-lived material seems the most practical approach to this issue and we strongly c~~ S\',()\\ICII STREET . PLY~H)l'TH . \1.\ 11:'1<,IJ tSUXJ 7-16 :COOi

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May 23, 1994 Page 2 reccmnend the continuation of the exemption in its current form. We thank the comnission for the opportunity to comnent on this important issue and look forward to coornenting on any proposed regulations that are forthcoming. onna Pechalonis, CNMT DP:jw

DOCKET NUMBER SAINT BARNABAS 0 PROPOSED RULE PH 20 MEDICAL CENT~J{l (5Cf FR C,/LJtj RONALD J. DEL MAURO *94 MAY 27 p i>~TMENT OF RADIATION ONCOLOGY President and Chief Executive Officer LOUIS SANFILIPPO, M.D., Chairman (201) 533-5630 OF FICE OF SECRf-TA~Y May 20, 1994 DOCKET! '.(: 9,. SEk 'ICE BRJ~. CH (jj) Secretary of the Commission United States Nuclear Regulatory Commission Washington, D.C. 20555 Attn: Docketing and Service Branch Gentlemen: It is with great concern that I respond to the proposed rulemaking published on February 25, 1994 in 59 FR 9146. I am specifically referring to the possibility that the Commission may drop the exemption for patient excreta to sanitary sewage systems. This course of action may very well lead to the extinction of Clinical Nuclear Medicine in the United States. Hundreds of thousands of these procedures are done safely each year. Should the exemption be dropped, the resulting radioactive waste storage problem would be enormous, both in logistics and cost. Hospitals would be forced to either collect and store urine and fecal material, or to build elaborate holding tanks with monitoring systems. The handling of patient excreta presents a greater biomedical hazard than the radioactive portion, which is minimal if at all existent. Many facilities have reduced clinical procedures, especially RIA, due to the lack of low-level radioactive waste disposal sites. Dropping the current exemption would create a crisis orders of magnitude higher~ as every hosp:i.ta 1 wH:h a N;_1Gle~r Medicine Department would be affected. Many would be forced to stop providing this vital patient service. An additional concern is the thousands of procedures that are done on an out-patient basis. Would these patients have to store their own excreta at home? Would they be required to bring it back to the facility where they were scanned? Would the facility be responsible for picking up the waste and transporting it back? Again, the storage and transportation problems would be enormous. 2 1 1994 d ..JUL.............. ___ Acknow1idged by OLD SHORT HILLS ROAD LIVINGSTON, NEW JERSEY 07039 (201) 533-5000 A nonprofit, nonsectarian medical center, founded in 1865, and a major affiliate of the University of Medicine and Dentistry of New Jersey

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There is no conceivable rationale for dropping the exemption. The exposure to individuals from this source is far below any current regulatory limit. As instrumentation becomes more sophisticated and sensitivity increases, it is indeed true that materials used in clinical procedures can be detected. However, just because something is detectable does not necessarily make it hazardous and consequently subject to regulation. Again, I feel that adding storage areas, handling, and monitoring excreta would introduce a greater hazard than currently exists. I urge the Commission to carefully consider the consequences of this proposal, and to maintain the exemption for patient excreta. Sincerely yours, Ira M. Garelick, M.S. Health Physicist IMG/aj

Genetics Institute, Inc. 87 CambridgePark Drive One Burtt Road Cambridge, Massachusetts 02140 Andover, Massachusetts 01810 Telephone (ii17J 876-1170 .p 8)4 14 Telefax '6171 876- 0388 OOC KCT[tJJ8J*/7) OO//S GuCr\c: T NUMBER PR USNRC PR POSED RULE 20 ( 51 FR. Cj I Lf~ *94 MAY 26 PJ :54 GENETICS . INSTITUTE OFFI CE OF SECRETA RY May 25, 1994 DOCKET! G & SERVICE BRANCH The Secretary of the Commission U.S. Nuclear Regulatory Commission Washington, DC 20555 Attention: Docketing and Service Branch

Dear Sir/Madam:

Genetics Institute wishes to provide the following comments regarding the Advanced Notice of Proposed Rulemalcing for "Disposal of Radioactive Material by Release into Sanitary Sewer Systems*, published in the Federal Register on February 25, 1994. Genetics Institute is a leading biopharmaceutical firm engaged in the discovery and development of human pharmaceuticals through recombinant DNA and other technologies. The company has a diversified portfolio of licensed and proprietary pharmaceutical products at various stages of development, including treatments for anemia, hemophilia, cancer, bone damage, heart disease, inflammatory conditions and immune system disorders. Disposal of radioactive materials to the sewer is performed in accordance with existing regulations and conditions of our NRC license. Radioactive materials, utilii.ed in our laboratory research and development efforts, generate a large quantity of low-activity high-volume aqueous radioactive waste. A large portion of this waste is soluble and readily dispersible biological material which is disposed of directly to the sanitary sewer system. Any changes to the regulations that would place new restrictions or further limit disposal by way of the sanitary sewer system would have a significant negative impact on Genetics Institute's radioactive waste management program, and upon our research and development efforts. Reduction in the amount of radioactive material released to the sewer would present a significant financial burden to the biotechnology industry in that liquid waste may need to be solidified for land disposal. This would be tremendously expensive given the current cost of disposal of solid radioactive wastes. In addition, access to burial sites may no longer be available to facilities such as Genetics Institute. More importantly, increased handling of this liquid waste would result in a greater potential for spills and higher radiation doses to the waste technicians; directly in opposition to our ALARA program. We thank the Commission for the opportunity to comment on this important issue and look forward to commenting on any proposed regulations that are forthcoming. Dale Blank Radiation Safety Officer and Vice President, Facilities & Technical Services JUL 2 1 1994

                                                                              .Aciulowtedged by card ............-     ....._.. _

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Academic Component lnati1u1ion1: Health Component Institutions: The University of Texas at Arlington The University of Texas Southwestern Medical Center at Dallas The University of Texas at Austin The University of Texas Medical Branch at Galveston The University of Texas at Brownsv1lle The University of Texas Health Science Center at Houston The University of Texas at Dallas The University of Texas Health Science Center at San Antonio The um*versity of Texas at El Paso The University of Texas*Pan American The UniversityofTexasM.D Anderson Cancer Center The University of Texas Health Center at Tyler DOCK ET ED The University of Texas of the Permian Basin The University of Texas at San Antonio The University of Texas Institute of Texan Cultures at San Antonio The University of Texas at Tyler USNRC

                                                                                                                                                             *94 MAY 26 P3 :58 ,

THE UNIVERSITY OF TEXAS SYSTEM Office of General Counsel OFFICE or SECRETARY 201 WEST SEVENTH STREET AUSTIN, TEXAS 78701-2981 DOCKETlr~G i~ SERV ICE TELEPHONE (512) 499-4462 BRA NCH FAX (512) 499-4523 Carolyn Wright Office of Environmental Affairs

                                                                                                                                                                           ~
                                                                                                                                                                           'CY Director DOCKET NUMBER PROPOSED RULE PR 20 May 25, 1994                                                                                                  ------

( sq FR o/13/6} VIA OVERNIGHf COURIER Comments Due: May 26, 1994 Secretary of the Commission U.S. Nuclear Regulatory Commission Washington, D.C. 20555 Attention: Docketing and Service Branch Re: NRC, 10 CFR Part 20, RIN 3150-AE90 ANPR: Disposal of Radioactive Material by Release into Sanitary Sewer Systems

Dear Mr. Secretary:

As the Director of the Office of Environmental Affairs, I make these comments on behalf of the six health-related institutions of the University of Texas System:

1. The University of Texas Southwestern Medical Center at Dallas;

2. The University of Texas Medical Branch at Galveston;

3. The University of Texas Health Science Center at Houston;

4. The University of Texas Health Science Center at San Antonio;

5. The University of Texas M.D. Anderson Cancer Center at Houston;

6. The University of Texas Health Center at Tyler.

Acknowledged by card ..-!ill-. 21 1

• Docketing and Service Branch May 25, 1994 Page 2 Apparently, the proposed rule stems from the detection of certain long-lived isotopes, (i.e., Am-241) at various municipal water treatment facilities around the country. We understand that such radionuclides are not commonly used in liquid form at research and clinical institutions such as those operated by the University of Texas.

To the extent they are used, however, a primary concern of our medical research facilities is that excessive regulations not encumber or burden the flexibility needed for research protocols. This goal can be accomplished by exempting medical research institutions from the more stringent regulations needed for non-research medical facilities or industrial operations. As a result, the University requests that a specific exemption from the rule for all educational and medical research institutions be included in the final regulations. If a total exemption is not possible, the University requests a clear statement describing the processes that are permitted by educational and medical research institutions. As indicated in the attached correspondence from the University of Texas Southwestern Medical Center at Dallas and the University of Texas M.D. Anderson Cancer Center in Houston, limiting the total quantity of radionuclides used 'in basic and clinical investigation would directly impair the University's contribution to health care and research into human disease. The University of Texas System adopts and incorpo-rates these comments. Furthermore, solidification and disposal through a radioactive waste contractor would be costly and use valuable landfill space. In many cases the radioactive material will have decayed before disposal in radioactive waste facility. Radioactive material used in biomedical research which is disposed of in such low concentrations does not pose a significant risk to the general public and should be exempt from regulation. If we can provide any further information, please do not hesitate to contact this office. Thank you for the opportunity to comment on behalf of the University of Texas. Sincerely, Carolyn H. Wright xc: Mr. Ray Farabee Radiation Safety Officers of the Health-Related Institutions of The University of Texas cwright\work~nsewfr.524

Docketing and Service Branch May 25, 1994 Page 3 bxc: Ms. Pamela S. Bacon cwright\work~nsewfr.524

09:02 002 nu. UNIVl!RSlTY OF TWS SOUTHWESTERN MEDICAL CENTER AT DALLAS Frederick J, Bonle, M.D. Bme and Worrord caln Dlsungulstted Chair In PlagnosUc Jmaglng I>i,ector, Nuclear Medicine Center May 6, 1994 Secretary of the Commission Nuclear Regulatory Commission Attention: Docketing and Service Branch Washington, DC 20S55 . By way of int.roduction I am Frederick J. Bonte, M.D., Professor of Radiology at The University of Texas Southwestern Medical School at Danas, Texas. Presently I serve as a member or the Oovemor~appointed Texas Radiation Advisory Board, for which body I chair its Medical Committee; 1 am a member of the Commission on Radiological Units, Standards and Protection of the American College of Radiologyj I am a former member of the National Council on Radiation Protection and Measurements. I would like to address the recent requests for public comments on matters involving disposal of radioactive material. The Nuclear Regulatory Commission should not attempt to set limits on the total quantity of radioactive material that can be released annually by a licensee, when that licensee is a laJJe institution such as our own ...In our set.ting there are three major hospitals and a very large research complex, in which a high percentage of laboratories employ radionuclides in basic and clinical invcsUgation. To limit the total quantity handled by such an institution would directly impair its contribution to health care, and to advancement of knowledge about human disease. The same admonili.on applies to the suggestion that "dose limits* might be applied. When the doses are those usod in human diagnosis and treatment the judgement of the ph)'sician who is trained in the use of radioactive materials must remain paramount in each individual instance. To interfere with medical decisions is well beyond tbe province of the Nuclear Regulatory Commission. The final issue involves the 11 continuation of exemptions for patient excreta". The concept of limiting the amount of radioactive materiaJ that a patient cou1d Soulhwemrn Medk:al Sthool !1323 Hany HIIIC5 BouleY.llnl / Dallas, Tew 7S23S-~l / (214)648*20~

09:02 003 Secretary of the coirnnission Nudear Regulatory Commission May 6, 1994 Page 2 excrete is an unfortunate one, since it would involve setting maximum values on the amount of radioactive material that oould be administered to a patient with a lifc--threatcning entity such as differentiated thyroid carcinoma. Further, if the Commission were to set tome sort of limits on the amount of C1tcreta that could bo introduced into the sanitary sewer system, institutions such as our own, which deal with numerous cancer patients, would be placed in an un~bJe position. We do not now have, nor will we have, facilities in which to store human wastes while radioactive decay takes place. We have always been satisfied that the almost infinite dilution . that occurs . in the sewer system affords ample protection . to the public, and lo the environment.

• Therefore, on behalf or myself, and all my co11eagues jn the practjce of medical treatment and research, I ask the Commission not lo alt.empt 1o regulate total quantities of radioactive material released by a lictnsee, nor Ute individual doses that may be administ.crcd to a patient, since to do so might well endanger the public health. Further I ask the Commission to continue ex.emptions for patient excreta, which I believe are presently being handled in a manner consonant with public safety.

Thank you f'or your attmtion to these matters. Sincerely yours,

  -P'/l;_):3P-Frcdtk \. Bontet M.D.

Cain Distinguished Chair in Diagnostic Imaging Professor of Radiology cJt cc: Jose Lopez, Ph.D. J Jack s. Krohmer, Ph.D.

Ov/20/94 15:15 U-713 790 1251 ENVHEALTHSAFETY iaioo2 TI-£ lNIVER5ITYOF TEXAS Radiation sa.fety Office 1fil.AN)ER50N EII.VlloimlentaJ. :Eeal.th and Safety [TI.3) 7!J:Z-3:Z34 Pll (713) 750-1.251 CANCER CENTER May 1.8, 1994 Secretary of the Commission U.S. Nuclear Regulatory Commission Washington, DC 20555

SUBJECT:

Advanced Notice of Proposed Rulemaking / Request for Information: Disposal of Radioactive Materials by Release into Sanitary Sewer Systems: FR/Vol.59, No. 38/Friday, February 25, 1.994/ 9146-9149.

Dear Mr. Secretary:

Thank you for this opportunity to comment on the above notice. As a genera1 comment, from the discussion and cases given in the FR Notice, the major reason for considering revising sewer disposal limits appears to be the mere deteotahi1i ty of certain radioisotopes and not to any real or even probable adverse health effects on either STP workers or the general public. This seems to be more and more the standard response of many regu1atory agencies. One of the prob1ems of responding in this way is that .any realistic exposure or activity release standards automatically become suspect by the general public or special interest groups. From another angle, it becomes more and more difficult for biomedical Licensees to assure compliance cf medical research and clinical staff to even realistic and necessary radiation safety procedures when that staff observes the constant racheting down of radiation regulatory limits below levels that have any scientific meaning. concerning the specific subjects listed: (1) Form of the Materiai for Dispoaai --- I am not aware a£ what effect, if any, sludge bioprocessors would have on reconcentrating radio-labe1ed buffers/organics commonly used in biomedical research, but I think the NRC should be very skeptical of making regulatory changes because of any theoretical effects. The nature of the vast majority of biomedically used materials disposed of in the sewer system is that upon sewer disposal they almost immediately break down into relatively simple compounds and are readily soluble or dispersible- The activity levels are likely ta be very low in any event, even with multiple, localized biomedical institutional releases. it would be currently be impossible for the University of Texas M.D. Anderson Cancer Center {UTMDACC) to otherwise dispose of our TEXAS MEDICAL CEmEl 151; HOLCOMBE BOULEVARD* HOUSTON, TEXAS 7i030 * (713) 792,2121 A C ~ O m c e r ~ D ~ b y die NarionaL~ ~

___o_a_1_20_1_9_4__1_s_:_1_1_ _'8';;;;_7_1_3_7~9~0--=1~2~51~----=ENVBEALTHSAFETY il)003 water soluble/dispersible radioactive waste/tissue. There are currently no available commercial disposal options. We are not permitted to incinerate any radioactive material, nor is this likely to occur unless NRC allows current sewer release limits for incineration also. There is not sufficient space available at UTMDACC for storage for decay to background levels (not an option for H-3 or C-14 in any case). (2) Tota1 Quantity of Materia1 --- In terms of actual biokinetics and health risks for the low levels of radio-labeled materials commonly used in medical research (e.g. H-3, C-14, P-32/33, S-35, Cr-51, I-125, etc.), the three current NRC total quantity limits on releases per year are probably too low. However, as a practical matter, these limits should be retained as they are simple to state,. understand and document. In my opinion this is much preferable to individual quantity/concentration/form limits for each radionuclide. The petitioner's request that all licensees provide at least 24 hours advance notice to the appropriate sewer treatment plant (STP) before releasing radioactive material to the sewer system is unnecessary and impractical, certainly in terms of biomedical institutions. UTMDACC releases some small amounts of radioactive material to the sewer system on a daily basis. These activities could probably only be detected, if at all, at the STP by expensive continuing on-line sampling and scintillation counting. I cannot see how this would serve any radiation safety purpose. However, I would support the petitioner's request that the NRC exempt materials that enter the sewer system waste stream from the requirements regarding NRC approval for incineration under current NRC regulations, certainly with regard to those radioisotopes commonly used in biomedical research. Given the radioisotopes and activities involved, the pathways for human exposure from radioactive wastes seem no more or less significant whether the wastes are dispersed in water or air. (3) Type cf Limits --- I think that the most realistic model of exposure from radioactive material released to a sanitary sewer system would be to assume that an individual would always ingest water after the water had passed through the system's STP. Credit should be given to the licensee for any extra water volume this model would provide. From the cases cited there appears to be no significant concentrations of contamination in sewage sludge from radioactive material used in medical research or patients. This is consistent with what one would expect from such radioisotopes and would indicate no significant exposure to STP workers. I recommend that the NRC !!Qt. consider a dose limit approach to sewer disposal primarily because the current regulations are

, . 0S/20/94 15: 18 '0'713 790 1251 ENVHEALTHSAFETY la) 004 adequate, particularly concerning radioactive material used in medical research or patients. If a dose limit approach is considered, i t shou.l.d be based on a ca1cul.ated dose of S00 mrem/year with a1l. of the terms, methods of calcu1ation and re.port reguirementa ciearly and realistically defined, part~cularly for biomedical. institutions. (4) Exemption of Patient Bxcreta Patient excreta should continue to be exempt from sewer release limits. Again, detectibility by no means equates with either actual or even probable significant personal exposure in terms of patient excreta in the sewer system. Although there has been a significant increase in the number of nuclear medicine diagnostic procedures over the years, the use of radioisotopes with much shorter ha.l.f-lives have mostly replaced longer half-life radioisotopes previously used. Any attempt to regulate the release of excreta from patients receiving nuclear medicine diagnosis would be totally impractical. Holding for decay excreta from hospi ta.lized patients receilring nuclear medicine therapy will definitely increase radiation exposures and contamination incidents involving nurses, nuclear medicine technicians and radiation safety personnel. This was our past experience at UTMDACC. Sincerely, M. E. Norton Radiation Safety Officer k,\user\lm0ri::.on\ol.dbud\~t:¢easev.l118111

(202) 429-5120 American College of Nuclear '94 HAY 26 P3 :57 Physicians May 25, 1994 OFFICE OF SECRETARY DOCKETING SERVICE Samuel J. Chilk BRAHC ~DOCKET NUMBER - Secretary of the Commission U.S . Nuclear Regulatory Commission PROPO E RULE 2O Washington, D.C. 20555 {S'1FR1JLJ/J Attn:Docketing and Service Branch RE: 59 FR 9146; Advanced notice of proposed rulemaking "Disposal of Radioactive Material by Release into Sanitary Sewer Systems"

Dear Secretary Chilk:

The American College of Nuclear Physicians (ACNP) and The Society of Nuclear Medicine (SNM) applaud the use of an advanced notice of proposed rulemaking by the Commission for an issue such as this. However, we are concerned that this is another example of NRC moving forward on an issue with no justifiable scientific reasoning. ACNP and SNM represent over 15,000 nuclear medicine physicians, nuclear pharmacists, nuclear medicine scientists, and nuclear medicine technologists involved in the delivery of essential health care. We strongly urge the Commission to refrain from making any regulatory changes to the current exemption of the disposal of patient excreta into sanitary sewer systems. The ACNP and SNM are extremely concerned that NRC is ignoring any type of cost-benefit analysis or risk assessment in proposing to change the limits on radionuclides disposed in municipal sewer systems. We see no evidence that there is any risk to either the public or the sewer system employees from the disposal of patient excreta. NRC must recognize that with the analytical equipment available today it is possible to pick up small traces of radioactivity in the sewer systems. This contamination has existed since 1936 when Nuclear Medicine began. However, as NRC acknowledges, Nuclear Medicine employs only trace amounts of radioactivity that then are disposed of through patient excreta in the sewer systems. To prevent this disposal it would require medical licensees to keep patients in the hospital until there was no chance of interaction with the municipal sewer system. It would also require the separation of excreta from all patients who have received a Nuclear Medicine procedure. In Nuclear Medicine over 10,000,000 diagnostic and 50,000 therapeutic procedures are conducted annually. Of all those procedures only about 6,000 patients need to be hospitalized (thyroid carcinoma therapies), for an average of about two days or a total of 12,000 hospital days. If disposal of patient excreta into the sanitary sewer system were no longer exempt, then patients and their excreta would be required to remain under hospital control for the current requirement of ten effective half lives storage decay: 80 days for hyperthyroid and thyroid cancer patients receiving 1-131, 140 days for leukemic and polycythemic patients receiving P-32, and 500 days for patients with metastatic cancer to bone receiving Sr-89. The corresponding required days of hospitalization would be 41,000 (80d) + 1,000 (140d) + 8,000 (500d) = 7.42 million hospital days compared to the currently required 12 thousand hospital days. At a cost of about $800/day the annual cost would be more than $5.9 billion compared to the current $9.5 million. This is only for the 50,000 patients, and does not even cover the cost of new plumbing and disposal facilities for storage and decay of stool and urine. 2 1 19 d .. ................

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ACNP/SNM Comments to NRC May 25, 1994 Page 2 We hope that these cost estimates will convince NRC that this rule would be far too expensive to implement and could cause the end of Nuclear Medicine. No hospital in the United States would be willing or able to meet these regulatory requirements and in all likelihood would stop offering Nuclear Medicine services. We would also like to point out that this would be a perfect example for a backfit rule. Currently, only regulations affecting the power reactors are subject to this rule. We would strongly urge the Commission to consider this rule for materials licensees as well. We are hard pressed to believe that Commission could justify any rulemaking of this sort if they were forced to meet the requirements of the backfit rule. ACNP and SNM would also like to point out the lack of significant risk assessment by NRC in offering this advanced notice of proposed rulemaking. In the six case studies that NRC offers it clearly notes in most that there was no harm to the public or the employees in question and that there were no levels above the current requirements in 10 CFR 20. We feel that this is significant when considering changing the current regulations. NRC chooses to use extremely conservative estimates in determining TDE for the public by assuming that any member of the public would get their drinking water at the point of discharge. ACNP and SNM believe this to be an unrealistic assumption. In addition employees working with the municipal sewer system, although not specifically trained in the handling of radioactive material, are very conscious about the chemical and biological risks involved with sewer disposal. We believe that it is highly unlikely that a worker in a municipal sewer system would receive a harmful dose of radiation through the course of employment. There is also concern about NRC considering the notification of local municipalities before discharging radionuclides into the sewer. In the area of patient care, currently most patients are discharged from the hospital after receiving a Nuclear Medicine procedure. To properly notify the local authorities in advance, medical licensees would be forced to keep patients in the hospital, creating extensive costs as mentioned before. We can understand how NRC may want licensees to notify the local municipality when a spill occurred above and beyond the regulations of 10 CFR 20, but unless that occurs, this proposed regulation would be extremely costly with no additional level of safety being achieved. In conclusion, the ACNP and SNM strongly urge NRC to shelve any reconsiderations of disposal standards for municipal sewer systems until risk to the public or employees of municipal sewer systems can be determined. We believe that the current regulations of 10 CFR 20 are adequate to govern this area and that any additional changes would be too expensive for industry to bear. Thank you for the opportunity to comment on this important topic. If you have any additional questions please feel free to contact Mr. David Nichols in our Washington Office at (202) 429-5120. ~]~=~~.~~ Sincerely Richard C. Reba, M.D. President President American College of Nuclear Physicians Society ofNuclear Medicine WHM/RCR:dn

7 Eli Lilly and Company DOCKETED U NRC 9

                                                                                                        ~

ul1y Curpcyc1!1-' ( ,r*I1Jr-'r I, j ll 1,Jr)(dl' l11d1 HI'! .Jtj:l~n, ( J1 /1 1'!1-. lJl)IJ *94 MAY 26 P3 :54 OFFICE OF SECRETA RY DOCKET l~~G & SERVI CE BR ANCH May 25, 1994 DOCKET NUMBER PR 2 O PROPOSED RULE VIA FEDERAL EXPRESS ------ (s1 Fl< °I IL/ r,) The Honorable Samuel J. Chilk Secretary of the Commission U.S. Nuclear Regulatory Commission Washington, D.C. 20555 Attention: Docketing and Service Branch Re: Comments or the Advance Notice of Proposed Rulemaking (ANPR) as Published in 59FR 9146-9149 (February 25, 1994)

Dear Secretary Chilk:

Eli Lilly and Company ("Lilly") is a global, research based corporation that develops, manufactures, and markets pharmaceuticals, medical instruments, diagnostic products, and animal health products. Lilly is a Nuclear Regulatory Commission ("NRC") licensed research facility. Lilly is responding to the NRC's February 25, 1994, request for comments and information (the "Request") as it evaluates its options for providing additional or alternative means of regulatory control over radioactive material releases into sanitary sewers. See 59 FR 9147. Lilly respectfully requests that the Commission consider and incorporate herewith the comments Lilly submitted on December 23, 1993, in response to the Northeast Ohio Regional Sewer District ("NORSD") petition published in the October 20, 1993 Federal Register (Lilly's comments are attached as Exhibit A). As explained within the following specific comments, it remains Lilly's position that it is not necessary, feasible or appropriate for the NRC to exercise additional means of regulatory control over disposal of radioactive material into sanitary sewers. ~ 10 CFR Part 20; Clean Water Act, 33 U.S.C. §1317(b) and (d) and §1319; See also EPA Clean Water Act Standards, 40 CFR Part 403 (national pre treatment standards for the control of pollutants which may adversely affect treatment processes). However, Lilly does support the alternative, sole use of concentration limits for measuring a licensee's limits for disposal of radioactive material into sanitary sewers. JUt t 1 AcKn wledgtd by card ..."-* -

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The Honorable Samuel J. Chilk May 25, 1994 Page Two

1) Form of Material for Disposal The NRC invited comments on: (a) to what extent and how NRC regulations should take into account the technologies for processing sewage; and (b) the potential impacts on licensee's operations associated with any additional restrictions regarding the forms of materials suitable for dispersal [sic].

Based upon the arguments fully set forth in Exhibit A, it is Lilly's position that the NRC does not need to take into account the technologies for processing sewage. The Clean Water Act requires an NRC licensee to establish an appropriate pre treatment program if its pollutants may cause interference with the processing technology used by its waste water treatment plant. 40 CFR 403.S(a). Each local waste water treatment plant has the authority and mandate to ensure local industrial water permit limits are appropriately developed and enforced. 40 CFR 403.5(c)(l). As the NRC indicates in its Request, sewer treatment and sewer treatment technologies are very localized issues. These local issues have been and will continue to be fully regulated pursuant to the Clean Water Act. Further regulation by the NRC will be costly, confusing and unduly burdensome for the licensees that currently comply with existing NRC and EPA regulations. If additional restrictions are imposed by the NRC regarding the forms of materials suitable for disposal, Lilly will experience (1) severe economic impact (new collection, storage, handling and disposal costs, retraining of personnel, etc.); and (2) increased personnel exposure due to the elimination of direct sewering disposal. In addition, although the NRC mentions its newly enforceable (1/1/94) standards found in 10 CFR Part 20 which narrow the forms of radioactive materials that may be permitted for disposal into sanitary sewers, the NRC fails to acknowledge that enforcement of the new standards may have eliminated the incidents described in the Request. 2-3) Total Quantity of Material/Type of Limits The NRC invited comments on: (a) the acceptability of the total quantity approach and whether a total quantity to be released should be specified or otherwise limited; and (b) whether it should consider limitation using a dose limit approach, and provide total quantity and concentration values in a Regulatory Guide to facilitate compliance with the dose limit.

The Honorable Samuel J. Chilk May 25, 1994 Page Three It is Lilly's position that any efforts to further regulate sewer disposal of radioactive material must consider the dose to the public. Although the NRC has described a limited number of incidents where radioactive materials have concentrated, those situations (a) were not in compliance with the newly enforceable standards; (b) were not representative of the overwhelming majority of sewer disposal situations; and (c) did not recognize that the dose to the public from sewer disposal ofH-3 and C-14 is a very small fraction of the dose already received from the natural presence of the two nuclides in the environment. Lilly urges the NRC to compare the total quantity limit of 5 Ci per year sewer disposal for H-3 to its global (natural production) inventory per year of 70,000,000 Ci. ~ National Council for Radiation Protection and Measurement (NCRP) Report 62. Approximately 663,000,000 Ci ofH-3 is projected to be released from natural production, atmospheric weapons testing, and nuclear power plants. NCRP Report 62 estimates the absorbed dose in tissue to man from the natural production of H-3 to be 0.0012 mrad/year. Based upon the current limits, any dose rate to the public from the sewer disposal ofH-3 from NRC licensed facilities will be much less. In addition, compare the total quantity limit of 1 Ci per year sewer disposal for C-14 to the C-14 global inventory of 3,800,000 Ci. NCRP Report 81. The natural C-14 inventory corresponds to a annual dose of 1.25 mrad/year, or about one percent of the total annual background of 100 mrad/year. NCRP Report 81 also states that the dose from all C-14 waste sources other than naturally produced C-14 is insignificant. Therefore, any effort to lower the amount of permitted releases to sewers would have no measurable effect on the amount ofH-3 or C-14 in the environment and/or the dose rate to the public. The current method of total quantity limits ("TQL") is arbitrary and should be eliminated. The TQL method does not take into account the volume of sewer flow at a large facility. As the Request demonstrates, in unique situations, the TQL method has not prevented the concentration of radionuclides in certain sewage treatment facilities. In the alternative, the concentration limit method takes the volume flow of the sanitary sewer into consideration. Concentration limits for sewer disposal are specific to the radionuclide and could easily include modifying factors for radioactive materials that have been shown to be a problem for sewer treatment plants (i.e. heavy metals). Radioactive materials with no history of causing problems for the waste water treatment technology (e.g. H-3 and C-14) would be held to the concentration limit and would not need any modifying factors. Therefore, it is Lilly's position that the NRC should adopt the concentration limit method as the sole method used to limit the sewer disposal of radioactive material.

The Honorable Samuel J. Chilk May 25, 1994 Page Four Conclusion For the foregoing reasons, the NRC should not use national rulemaking to address isolated problems associated with industrial users' interference or pass through ofradionuclides at waste water treatment plants. However, in order to better assist the localities as they develop and enforce the required local pre treatment limits/conditions, the NRC should move from the use of total quantity limits to concentration limits and concentration limits with modifying factors as the sole type oflimits used for NRC permitted releases to the sanitary sewer. Lilly would be pleased to discuss these comments at your convenience. Please contact Stanley Hampton, Assistant Radiation Safety Officer at (317) 276-7862 with any questions. Sincerely, ELI LILLY AND COMPANY Martha Carter hatti, Ph.D. Radiation Safety Officer

Eli Lilly and Company December :23. 1993 CERTIFIED :JAIL RETURN RECEIPT REQUESTED Secretary of the Commission U.S. Nuclear Regulatory Commission \Vashington. D.C. 20555 Attention : Docketing and Service Branch Comments on the Petition for RulP.mak:ing Presented by Northeast Ohio Regional Sewer District as Published in the October 20, 1993, Federal Register

Dear Secretary of the Commission :

In 58 Fed. Reg. 54071 (October :20. 1993), the Northeast Ohio Regional Sewer District's Southerly wastewater treatment plant ("Southerly" ) petitioned the Nuclear Regulatory Commission ("NRC" ) for a rulemaking, which it is allowed to do under the Administrative Procedures Act ("APA") and 10 C.F .R. 2.802. Specifically, Southerly requested that existing NRC regulations be revised:

1. to require 24-hour advance notice to the local wastewater treatment plant from all NRC licensees prior to discharging radioactive waste or materials containing radioactive waste into a sanitary sewer system: and

2. to exempt incineration of sanitary waste streams from NRC's current ban against incinerating radioactive waste without first obtaining NRC approval (i.e. , a licenseJ.

Eli Lilly and Company 1*'Lilly") is responding to the NRC request for comments on the appropriateness of Southerly's petition. Lilly's comments pertain only to Southerly's request for 24-hour required notice prior to disposal of radioactive wastestreams. which we believe should be denied. Implicit in Southerly's argument for rulemaking is that advance notice to wastewater treatment plants is necessary to protect the public and to ensure proper f~ctioning of such plants . Southerly provides as support for this position its own experience of not knowing until recently that its wastewater treatment plant had been contaminated by years of exposure to accumulated industrial discharges containing Cobalt-60. As further support. Southerly cites a few plants elsewhere in the United States which may be experiencing similar problems. ~ 58 Fed. Reg. at 54071 .

-;ecretary of the l *(J mm1ssion Pagel December 23. 199:3 Lillv helieves that .:-,outherlv*s petition is nothing more than a veiled attempt to get the NRC to fix a problem that ::5outherly by law was supposed to previously investigate and guard against and which Southerlv could have corrected and still can correct on its own through existing regulatory- authority regardless of whether NRC denies Southerly's request for additional rulemaking. Lilly's position derives from the following arguments: the Clean Water Act requires \and has always required J Southerly to prohibit discharges of radioactive waste that cause environmental problems. meaning Southerly not only has the means currently to prevent or limit further discharges of Cobalt-60 but that Southerly's problem was caused by Southerly's failure to follow Clean Water Act requirements and not because the NRC's rules do not require advance notice of radioactive discharges: in any event. the Clean Water Act already requires industrial discharges to provide notice to wastewater treatment plants upon discovery of potential problems or excessive discharges: the discharges which Southerly wants nonce concerning are made only pursuant to NRC licenses containing limits that protect public health: and Southerly's petition. if granted.

would result in a national ruiemaking as a solution to a local problem that should be corrected instead through case-by-case licensing. Furthermore. Southerly's petition. if granted. would impose unnecessary yet significant burdens on those industrial dischargers and wastewater treatment plants which, through compliance with existing Clean Water Act and NRC regulations. are not experiencing the problems which Southerly and, at most, a few other plants have endured. A. Implications for Southerly's Petition Created by the Clean Water Act

1. Pretreatment Programs Under 40 C.F .R. Part 403. wastewater treatment plants must implement EPA's national pretreatment standards in a way to control pollutants that are discharged by industrial users of a sanitary sewer system from adversely affecting these plants' treatment processes . Pursuant to 40 C.F.R. 403 .5. under any circumstance. "a user may llQ1 introduce into a

[wastewater treatment plant] any pollutants which cause pass through or interference ., or which might contaminate the plant or the sewage sludge that is generated. Each plant. such as Southerly, which handles a total design flow of greater than 5 million gallons/dayl and which receives from industrial users pollutants that might cause interference is required by the Clean Water Act to establish a pretreatment program. 40 C.F.R. 403.8(a). In order to fulfill this obligation, the wastewater treatment plant "shall" develop local water permit limits for the appropriate industrial dischargers or users of the sanitary sewers. If the plant, in working wi.th the local permitting agency, does not impose such limits then it is required to demonstrate that such limits are unnecessary. 40 C.F.R. 403.8fl4). Each lToe Southerly treatment plant is designed to handle 175 million gallons1day of wastewater.

."':lecretary of the t '()mrmss10n P:..i!!e J December 23. 1993 wastewater treatment plant required to develop a pretreatment program

            ":-ohall . enforce specific limits to implement the prohibition against interference ... --t-0 C.F .R. 403 .S(cJ( l l. In fact. the wastewater treatment plant is required to continue developing local industrial water permit limits and to provide for more effective enforcement *'as necessary." Id. Thus. plants not creating and enforcing such pretreatment programs contravene Clean Water Act requirements and subject those plants to administrative or judicial action by EPA for penalties and/or an injunction. See 33 U.S.C.
             ~1317(b) and (di: ~1319.

The fact that Southerly has a Cobalt-60 problem is probably due to Southerly's failure to create a sufficient pretreatment program. If Southerly had an effective program and had done sufficient research into the wastestreams of its industrial users. or required those users to provide the necessary data. then the Cobalt-60 contamination should never have occurred. Thus. it appears Southerly is trying to get the NRC to adopt nationwide procedures that Southerly should have already instituted on a local level under the Clean Water Act. Regardless of why the Cobalt-60 problem exists. it is clear that Southerly under 40 C .F.R Part 403 possesses sufficient legal authority to require its users to provide advance notice. In fact, this authority is broader-- Southerly can (and probably should) impose appropriate limits on Cobalt-60 discharges and check to see whether those disposing it are licensed by the NRC. 2 Thus. there is no need for Southerly's petition for rulemaking.

2. Notice Sufficient requirements for notice to wastewater treatment plants are currently contained in EPA's Clean Water Act rules. which is yet another reason Southerly's request for an NRC rulemaking is unnecessary. EPA requires *'immediate notice to the local wastewater treatment plant when an industrial user suspects (not knows ofl an ongoing or immediate violation of its water permit. See 40 C.F.R. 403.12f(users *'shall notify the

[wastewater treatment plant] immediately of all questions that could cause problems to the [plant], including any slug loadings). Furthermore, EPA requires industrial users who learn of a previous violation to contact the wastewater treatment plant within 24 hours of becoming aware of such violation. 40 C.F.R. 403.12g(2). Thus. Southerly should be receiving sufficient notices to address its Cobalt-60 problem. As seen above, it can certainly require these notices if they have not been forthcoming.

   '.?.If these industrial users do not possess appropriate NRC licenses, then Southerly i and the NRC) under existing law can enforce against these users . No new rulemaking would be needed from the r--;RC to accomplish this.

~ecretarY of the t *11mm1ss10n P:.1ge 4 December L:~. l'.J~n The univ nonce~ th:1t Southerlv needs are those already required hy EPA: EPA reqwrec; rnciustriai users to alert their treatment plants to possible problems immediately and to report all *violations. There is no general need 3 to reqmre advance notice of discharges that otherwise comply with hoth the user*~ water permit effluent limits and the user*s NRC license. These permits are required to have limits that are safe. If the wastewater treatment plant is concerned about discharges complying with these limits. it ought to reopen the permit and establish new limits rather than impose a notice reqmrement on every industrial discharger in the United States. B. Implications for ~outherly's Petition Presented by NRC Rules The NRC is required by its enabling legislation to regulate generators and disposers of radioactive materials and wastes such that public health and the environment are adequately safeguarded. See. e.g,, 58 Fed. Re~. at 54071 ':,-.J'RC admits It is charged \Vith establishing standards for protection against ionizing radiation resulting from the activities conducted by [NRC1 licensees ." 1 Tn 10 C.F.R. 20 .303 and 10 C.F.R. 20.2003. the NRC imposes extremelv stnngent requirements on those who would discharge radioactive wastes into a sanitary sewer system (i.e., one year total may not exceed one curie per pollutant/. These limits even account for a source's daily, monthly. and yearly sewer flows. And before these discharges can be made. the source must obtain prior approval from the NRC in the form of a license. Clearly, Southerly*s petition requests advance notice of only licensed discharges: unlicensed discharges of radioactive waste are not allowed by the NRC ( or EPA) and no one would argue that the legal means to prevent such discharges does not already exist. Given that only licensed discharges are focused on hv Southerlv. there is no need for advance notice for discharges that *m eet the c-o~ditions of the NRC license. Through public notice and comment. that license with all of its conditions was legally issued for the source and it represents a safe allowable loading. In fact, there is no real benefit from requiring advance notice of discharges that comply with the source's license. The local wastewater treatment plant operators are not likely to possess the expertise to evaluate the risk of a source's radioactive discharge. Undoubtedly, they would defer to what the NRC said is safe in the source's license. Furthermore. the NRC overprotects public health and the environment when it issues licenses to sources disposing of radioactive materials. For 3The onlv time advance notice would be appropriate would be if the wastewater treatment plant. in order to adequately handle certain radioactive discharges, needs to take precautionary measures or alter its normal treatment processes. Southerly's request is not limited in this regard. Even if these facts did ex.ist for Southerly, it would be due to a local problem not justifying a national rulemaking.

Secretarv ot' the l *,Jmm1~:01on Pue:e 5

• December 23. l~\-n example. 111 NRC Rcgulatorv (~uide 8 _:37 " ..\LARA Leveis for Effluents from

-.1aterials Facilities* ,.July 1993). the NRC :-;ei:.s as a fsOal that sources discharge no more than 10-20 percent of their otherwise allowable limits.

These ALARA ; as low as reasonably achievable I goals are often included as enforceable co nditions in NRC licenses. Consequentlv. the onlv notice needed bv Southerlv is notice of a violation or imminent violation or" a NRC license o~ water pe~it. and this notice is already required under the Clean Water Act. C. Implications for Southerly's Petition Due to Application of General Administrauve Legal Principles In denying S outherl:v*s petition for rulemaking, nothing in the APA or NRC's own regulations v,:ould require the NRC to act further. Courts do not. except in unusual circumstances. such as an agency being arbitrary and capricious . ljUestion an agency's denial of rulemaking. ~ ~ Arkansas PO\ver & Light C'o. v. ICC. 725 F.2d 716 (D .C. Cir. 1984) (stated that courts \v1ll compel agencies to institute rulemakings only in an "extremely rare instance). As long as the NRC in denying Southerly's petition explains the facts and policy the denial relies upon and shows that the facts have some basis in the record, courts will defer to the NRC's decision. See also Heckler v . Chaney, 470 U.S. 821 (1985) (Supreme Court refused to reopen the FDA's decision not to enforce against a potential violator/ . More importantly, courts are clear that it is inappropriate to convert a local problem into the need for a national rulemaking and that an agency will always be justified in denying a petition to do so. In Arkansas Power & Light. the ICC denied such a petition and was upheld by the court. The court stated that the "case for deference to the agency's decision not to undertake rulemaking is made even stronger where the alternative is not maintenance of the status quo but the formulation of standards via case-by-case adjudication ... 725 F .2d at 723. Thus, rulemaking should be initiated. and. even in those rare cases where an agency ignored its responsibilities. will only be required when a national ~ is presented which necessitates uniform. widespread and binding enforcement. Southerly may argue that its petition does not involve case-by-case considerations and that notice should always be required. But. to the contrary, Southerly's petition is merely a mask for what is a localized problem affecting that plant. 4 Southerly does state that in seven other locales wastewater treatment plants have encountered problems similar to 4 In fact . Southerly s problem 1s with the discharge of a single pollutant not generally generated by most NRC licensees: Cobalt -60. This is further reason not to engage in a national rulemaking for all pollutants and all mdustnal users.

<ecretarv nt the <..'umm1ssion Pag-e ti 0e cemoer :.:'.3. E)93 its own. :1,-3 Fed. Reg. ::.it 54071. However. Southerly fails to pomt out that the hundreds of other wastewater treatment plants in the United States cio not expenence this problem of contamination. There are significant burdens associated with requiring advance notice as desirelby Southerly. The ovenvhelming maJority of wastewater treatment plants , and their industrial users 1 who have effective pretreatment programs should not be forced to incur additional time-consuming responsibilities in order to provide federal assistance to a minority of plants who have failed to establish effective pretreatment programs. The Arkansas Power & Light court. in part. upheld the ICC's denial of rulemaking because of this concern. 725 F .2d at 722 ("development of a nationwide database [here] is unnecessarilv cumbersome because it would require numerous railroads. operating both efficiently and inefficiently, to provide data that might never be used.) I emphasis added}

         .Just as in Arkansas Power & Light, Southerly's petition for rulemaking would result in sources reorganizing their business to provide notices to wastewater treatment plants that \vill not provide meaningful information:

the notices wi.11 only inform the plants that a discharge in compliance with the source*s \vater permit and NRC license is forthcoming. Some of the burdens and consequences associated with this unnecessary rule include the following:

1. the wastewater treatment plant will have to devote resources to process and review notices that are submitted:

2. the industrial user will no longer be able to sewer directly in compliance with its permit but will instead need to take steps to collect and store the radioactive material until 24 hours have passed:

3. storage and handling will be time-consuming and expensive (Lilly would need to hire one more full time employee and spend over

                  $30.000 for storage containers i:

4. requiring the industrial user to collect its effluent containing radioactive material prior to discharge will serve to concentrate the radiation involved and expose more people to the material than would otherwise be exposed if direct sewering had occurred: and 0 _ if in order to avoid dealing with a mandatory notice requirement. the wastewater treatment plant decides to prohibit all discharges of radioactive waste. Lilly estimates it would incur $425.000/year more in disposal fees and would have to hire and train two new employees in order to convert the liquid waste into absorbed solids placed in disposable drums.

.' ecretarv of the ( 'umm1ss1on Pa!!e , December L3. 1993 Finalh. EPA has heen clear that the details of any problems associated with industrial users* interference or pass through of pollutants at \vastewater treatment plants should not be dealt \\ith through a national rulemaking. Instead. EPA require s states and wastewater treatment plants to develop local pretreatment limits and conditions on an individualized basis. ~ee, e.g,. 55 Fed. Reg:. 30082. 30105 (,July 24. 1990) (EPA's experience in developing and overseeing the pretreatment program has led it to believe that individual control mechanisms are the best way to ensure compliance with applicable pretreatment standards. requirements [and prohibitions] .") Conclusion For the foregoing reasons. the NRC should deny the Southerly petition for a rnlemaking that would require all wastewater treatment plants to impose an obligation on industrial users to provide 24-hour advance notice of discharge of radioacuve materials to sanitarv sewer svstems . If the NRC nonetheless decides to initiate rulemaking, even tho~gh the Clean Water Act already provides the legal protection Southerly says it needs. then the rule finally adopted by the NRC should only allow I not require J wastewater treatment plants to obtain advance notice if. in their discretion. a local situation justifies it. Lilly would be pleased to discuss these comments at the Secretary of the Commission*s convenience . Please contact the undersigned at !317) 276-3753 with any questions. Sincerely, ELI LILLY AND COMPANY

                                              '~            t:') . \
                                                            /""'-, I1 I

c:t"tv :c:-\ C.:- /f--vc*/ David R. McAvoy Attorney kj

The Du Pont Merck Pharmaceutical Company Radiopharmaceutical Division 331 Treble Cove Road N. Billerica, MA 01862 DOCKETED

                                                                                                              @)

(508) 667 9531 us rnc May 24, 1994.

                                                                                        *94 t1AY 26 P3 :54 DOCKET NUMBER PROPOSED RULE PR 20

( S C/ F R._ C/_I_ L-/ 6

                                                                          -D-        OF ICE OF SECf t. ~ARY DOCKET \ G & -1ER

• IC E The Secretary of the Commission DU PONT U.S. Nuclear Regulatory Commission BRA CH MERCK Washington, DC 20555 Attention: Docketing and Service Branch Regarding the Advanced notice of proposed rulemaking, RIN 3150-AE90, "Disposal of Radioactive Material by Release into Sanitary Sewer Systems" distributed on 2/25/94, the DuPont Merck Pharmaceutical Company (DMPC) offers the following comments on current regulations, and the proposed changes in regulations.

1. Radionuclide half-life is a significant factor effecting radioactive material reconcentration in sanitary sewer systems, although the current regulations only identify the compound solubility as a factor. The radionuclides involved in the instances of reconcentration all have relatively long ( > 100 days) half-lives:

Am-241 432 yrs Po-210 138 yrs Cs-137 30 yrs Cs-134 13 yrs H-3 12 yrs Co-60 5 yrs Mn-54 0.86 yrs Radionucides used in radiopharmaceuticals have typical half-lives of 2 to 3 days, making it very unlikely that these would reconcentrate in sanitary sewer systems, since the rate of radioactive decay would exceed the reconcentration rate. Radionuclide half-Hfe must be considered along with solubility when determining limits on the release of radioactive material to sanitary sewerage.

2. Regulations should re-establish concentration and total activity limits for dispersible radionuclides, having half-lives of less than 100 days, or define activity release levels that are below concern based on 10 CFR Part 20 Appendix C quantities.

3. Instances of radionuclide reconcentration have resulted in estimated doses to individuals which are well below the current 10 CFR Part 20 annual limit to members of the general public of 100 mrem, and are approximately 100 times lower than the dose of 500 mrem via ingestion, which radionuclide concentration limits in 10 CFR Part 20 Appendix B are based on. A model which predicts actual dose to members of the general public should replace the current unrealistic model which assumes an individual is consuming effluent at the point of discharge.

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4. The need for additional restrictions on the release of radioactive material to sanitary sewerage does not appear to be warranted at this time since the impact the new 10 CFR Part 20 regulations will have on the instances of radionuclide reconcentration in sanitary sewerage have not been evaluated. Licensee effluent releases will be reduced by the implementation of the new 10 CFR Part 20 regulations, in which sewerage radionuclide concentrations limits were reduced by a factor of

10. The ALARA regulation in 10 CFR Part 20, and ALARA program requirements contained in NRC Regulatory Guide 8.37 "ALARA Levels for Effluents from Materials Facilities" should also result in the reduction of radionuclides released from facilities to sanitary sewerage.

5. Radionuclide reconcentration appears to be a very rare occurrence, 6 instances have been identified out of 15,000 (0.04%) sewer treatment plants, and 23,000 (0.02%) licensed users of radioactive materials.

Imposing additional restrictions on release to sanitary sewerage do not appear warranted based on the few occurrences of radionuclide reconcentration.

6. Health risks associated with the current limits for radionuclide release to sanitary sewerage should be comparable to health risks of other hazardous materials present in sewer sludge such as heavy metals.

7. The proposed requirement that all NRC licensees provide 24 hour notice prior to the release of radioactive material into sewerage is unnecessary. Radioactive material released to sanitary sewerage typically represents incidental radioactivity resulting from manufacturing processes.

Sincerely. L~ Dennis Dumas Manager, Safety and Environmental Engineering

CITY OF DOCKETED USNRC OAK RIDGE

                                                                     *94 MAY 26 P3 :57 POST OFFICE BOX 1

• OAK RIDGE TENN~$SEE 37831 - 0001 OFFI CE O~ SECRETAR Y OOCKET 1XG & SERVICE BRANCH May 24, 1994 DOCKET NUMBER PROPOSED RULE PR 2O

( St:/ FR q ILf£} The Secretary of the Commission U.S. Nuclear Regulatory Commission Washington, DC 20555 Attn: Docketing and Service Branch Re: 10 CFR PART 20 Disposal of Radioactive Material by Release into Sanitary Sewer Systems To Whom it May Concern: The City of Oak Ridge currently has several dischargers of radioactive materials connected to its Sanitary Sewer System. The health and safety of our workers continues to be of utmost importance and concern. The continued safe disposal of waste solids from our Treatment Plant remains a concern as well. The attached comments are intended to be in support of stricter control by the Commission of radioactive discharges. It continues to be .the City's position that current regulations are inadequate to thoroughly address all the issues a municipally operated wastewater collection and treatment system must face when these materials are introduced into its system. Should additional input be desired, please contact me at phone number (615) 482-8431. Very truly yours,

  ~~
 -Ga~ . ~ der, P. E.

Director of Public Works GMC/ks

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City o( Oak Ridge Comments oo the Advanced Notice of Proposed Rulemaklng on 10 CFR Part 20, Disposal or Radioactive Material by Release Into Sanitary Sewer Systems General Comments The City of Oak Ridge has long recognized that the current approach to limiting discharges of radioactive materials into sanitary sewers is not adequate. We first became aware of the problems associated with these discharges in 1984 when elevated levels of several radionuclides, including Co-60 and Cs-137 were discovered in the sludge from our municipal wastewater treatment plant Discharges from a stateDiiceused industrial facility involved in the decontamination of nuclt>.ar power plant components were identified as the primary source of the.ere radionuclides: Since 1984 our sludge ha~ also heen found to contain elevated concentrations ofl-131 and uranium. Patient excretions following nuclear medicine procedures at the local hospital were identified as the major source of 1-131. Discharges from a state-regulated facility that processes uranium metal and from the Department of Energy's Y-12 Nuclear Weapons Plant were found to be the major sources of the uranium in our sludge. With the *exception of 1-131, discharges of radioactive materials to the Oak Ridge sewer have been significantly rr,duc-.ed in recent yt>.ars. However, low levels of *co-60, Cs-137, and uranium, as well as rclativcly*high levels of 1-131, arc

• still ~outinely detected in our sludge: ** * * .: * * *
• In the absence of any federal standards on acceptable levels of radionuclides in sludge, the *
• radioactive materials present in the Oak Ridge sludge have been a source of continuing concern, and significant expense, relative to the disposal of the sludge through land application. ( )ver the lao;t few years, the related expense.~ have exceeded $1 ()(),(XX) per year.

As a result, we have recently developed and arc in the process of implementing our own criteria for controlling discharges of radioactive materials to the Oak Ridge sewer system. While we are pleased that the NRC is considering modifications to the current regulations, we are concerned that an adequate plan for limiting discharges cannot be developed without first determining the appropriate "endpoints." From our perspective, the primary concerns are:

1) ensuring that treatment plant workers and personnel involved in maintenance and repair of the collection system are protected (i.e., limiting the concentrations discharged), and

2) ensuring that the treatment plant sludge remains acceptable for disposal by traditional methods, such as land application or landfilling (i.e., limiting the quantities discharged).

The typical approach to limiting sewer discharges, for contaminants that concentrate in sludge (e.g., heavy metals), involves determining an allowable plant loading based on the

• sludge limit for the* contaminant and the removal efficiency for the contaminant during treatment.

of City Oak Ridge Conuuents on NRC 2 ANPR for 10 CFR 2~Sewer Disposal Witho11t first .e.._tahli1-h_ing what levels of radioactive materials in sewage sludge are ftaci::cptablc" relative. to the various sludge disposal options, there* is not *a basis for .... ~levelqping appropriate quantity limits for discharges of radioactive materials to public

   , sewer systems.

For your information we have included two publications that pertain to the behavior of radioactive materials within the Oak Ridge trt>.atment system: Ingvar L. Larsen, S.Y. Lee, H.L. Boston, and E.A. Stetar. 1992. Discovery of a 137Cs hot particle in municipal wastewater treatment plant sludge, Health Physics 62(3):2350238, Elisabeth A. Stetar, Harry L. Boston, Ingvar L. Larsen, Michael H. Mobley. 1993. The removal of radioactive cobalt, ct>sium and iodine in a conventional municipal wastewater treatment plant, Water Environment Research, 65, 630. We have also included a report. titled De,*elopment ofRadionuclide Discharge Criteria/or the Oak Ridge Sewer, that describes the approach we have developed for controlling discharges of radioactive materials to our sewer system. These discharge criteria will be implemented through our existing Industrial Pretreatment Program. Specific Comments

1) For._. or Material for Disposal Requiring that only soluble material be discharged is one means of reducing the fraction of a radioactive material that is removed from the wastewater during tre-.atment and subsequently concentrated in the treatment plant sludge. 1lowever, it i;hould he recognized that after discharge, some of the soluble material will partition to the* suspended solids within the wastewater prior to reaching the head of the ti:eatme1,1t plant" A high percentage

 . , 9f.,this.solids-asoociated fraction will be removed during primary settling of the w~tewater, and lh~ remainder will be removed during secondary treatment. Furthermore, some of the radioactive materialthat enters the plant in a soluble form will become associate.cl with the secondary treatment solids and be removed during final settling of the wastewater.

For example, an overall removal efficiency of 30% was observed for a soluble Co-58 tracer discharged to the Oak Ridge sewer (Stetar, et al., 1993). Seven-percent was removed during primary settling, and an additional 23% was removed during secondary treatment.

2) Total Quantity of Material As discussed in the enclosed report, Del'elopment of Radionuclide Discharge Criteria for the Oak Ridge Sewer, the established approach for controlling discharges of nonradioactive contaminants does consider the "capacity and treatment methods used hy the wa...tewater treatment plant" and the potential existence of multiple dischargers. We feel strongly that

City of Oak Ridge Comments on NRC 3 ANPR fur 10 CFR 20-Sewer Di!>posal this same approach should be taken when limiting discharges of radioactive contaminants as well. Furthermore, we believe the annual quantity limits specified by the current NRC regulations are too high to effectively limit radionuclide discharges to municipal wastewater treatment plants. For ex.ample, if a facility discharged one curie of Co-60 into lhe Oak Ridge sewer over a period of one year, and 30% of that Co was concentrated in the sludge as has been obsetved previously (Stetar et. al, 1993), the resulting average sludge concentrations would he 18,(MK> pCi/kg wet wt.-1 The maximum concentrations could actually be much higher depending upon the rate at which the Co-60 was discharged within the year. In addition, NRC's annual discharge limits are inappropriate for low specific

      . , ~tivity ,radionucl!des2 such as 2~RU. One curie .of 2,Ru corresponds to over 3000 kg of
   * **.*uranium Therefore, ir' one curie of deplele<I t1ranium;. ~bich i!! primarily 238\J, were

.*.-:. , ~charged*the result would be sludge that is sigmficantly greater thll)l 0.05% by weight uranium (i.e.; licensable source material). * * * *

3) Types of Limits As slated in our generctl comments, both concentration and quantity limits are needed lo ensure protection of workers and to ensure the treatment plant sludge remains acceptable for disposal through traditional methods.

Concentration limits: We strongly disagree with the current NRC provision that allows licensees to average their discharges over the entire monthly volume of sewage when demonstrating compliance with the concentration limits. This provision encourages the use of dilution as a means of meeting the regulations. This practice has been employed by at least one radioactive materials discharger in Oak Ridge. Quantity Limits: The residence time for sludge, as well as the degree of mixing the sludge undergoes, within the treatment plant should be considered when establishing the time period over which to limit the quantities discharged. The residence time varies from plant to plant, but rarely exceeds a month or two. Therefore, we believe a monthly discharge limit would be more appropriate than the current annual limit.

4) Exemption of Patient Excreta We believe this exemption should he reconsidered and that a thorough evaluation of the potential impacts of these releases is warranted. Furthermore, we arc concerned by the likelihood that many municipalities are not aware that patient excreta are a potentially

          *1. Based ~n ~~erage annual sludge. generation rate:9f approximately 17 million kg (wet wt.).                                       * * . *.. *. . .. . .. ...
         ' 2 Spedflc. activity is the activity of a radionuclide per unit mass. S'pecitlc acllvlly Is a function of the half.,.Ilfe of the rntllonudtde (Le., the rnte at which it decays). :Radionuclldes that decay slowly have a low specific activity.

of Cify Oak Ri.dge C:0111111ents on NRC 4 ANPR for 10 CFR 20-Sewer*Dlsposal .. significant source or radioactive materials or that these relea.c:;es are exempt rrom the regulations. As stated abQve, relatively high levels of 1-131 are present in our wastewater treatment system The source of this 1-131 is patient excreta, primarily urine, following nuclear medicine procedwes atthe local hospital. One such procedure, known as thyroid ablation, which is performed several times each year, involves the administration of as much as 100 to 150 mCi of 1-131. A significant fraction orthe iodine is excreted to the sewer within the first 48 hours. Based on data from the local hospital, roughly 500 mCi of 1-131 is released to the Oak Ridge sewer each year. For comparison, the total estimated Co-60 discharge to the treatment plant last year was less than 1 mCi. Peak 1-131 concentrations measured in the treatmenl plant following thyroid ablalioIDI include 30,000 pCi/1 in Lhe planl influent and 46,000 pCi/kg-wet wt. in the thickened, secondary treatment plant sludge. The peak levels observed in the digested sludge as it is removed for land applk.ation are typically 1000 to 2000 pCi/kg wet wt. The maximum observed to date in this sludge is 4000 pCi/kg. If it were not for the long sludge-retention time provided by our anaerobic digestion process, the 1-131 levels in our land applied sludge would be significantly higher. In treatment plants without long retention times, 1-131 may be a source of radiation exposure to individuals involved in the treatment and disposal of sludge. Although elevated concentrations ofl-131 are measured in treatment plant sludge, it should be recognized that only a small percentage (5-25%) of the 1-13 l that enters a treatment plant is removed with the sludge. Most of this radioactive material, remains hi the wastewater and is discharged with the treatment plant's liquid effluent (Stetar et al, 1993., Erlandsson and .Malls,;oo; 1978; Erlandsson el al., 1989, and Prichard el al., 1981). The retention lime

 . fo{ liq~ids ~ithin a wastewater, treatme~t plant is. sho~ *approxiI~tely 24 to 48 hours.

• Tb;d-efore, it is likely that 1-131 concentrations in excess of the* NRC criteria tor eftluents to unrestricted area.._ are discharged hy municipal wa..tewater treatment planl._,

In addition to 1-131, it is estimated that over 7 Ci (7200 mCi) of Tc-99m and 0.6 Ci of Tl-201 are released to the Oak Ridge sewer via patient excretions each year. Because these radioactive materials are short-lived they do nol accumulate in lbe lrealmenl plant sludge. However, we are concerned that near the point of discharge these releases, especially when combined with the high releases ofl-131, are potentially significant sources of radiation exposure to personnel involved in the maintenance of the collection system. References Elisabeth A. Stetar, Harry L. Boston, Ingvar L. Larsen, Michael H. Mobley. 1993. The Removal of Radioactive Cobalt, Cesium and Iodine in a Conventional Municipal wa..tewaterTreatment Plant. WaterF.nvimnmentRe:,earr.11, 65, 630. Erlandsson, B., and Mattsson, S. 1978. Medically Used Radionuclides in Sewage Sludge. Water, Air, and Soil Pollution, 9, 199.

City of Oak Ridge Comments on NRC 5 ANPR for 10 CFR 20-Sewer Dii,posal Erlandsson, B., Bjunnan, Mattsson, S. 1989. Calculation of Radionuclide Deposition by Means of Measurements on Sewage Sludge. Water, Air, and Soil Pollution, 45, 239. Prichard, H.M., Gesell, T.F., Davis, E.D. 1981. Iodine-131 Levels in Sludge and Treated Municipal Wastewater Near a Large Me.dical Complex. Am J. Public Health, 71, 1, 47.

TECHNICAL MEMORANDUM DEVELOPMENT OF RADIONUCLIDE DISCHARGE CRITERIA FOR THE OAK RIDGE SEWER Report on Tasks 5 and 8 of the Agreement Between the City of Oak Ridge and Lamar Dunn and Associates, Inc., Dated January 31, 1992 Prepared by: E.A. Stetar Certified Health Physicist Performance Technology Group, Inc. April 28, 1994

DEVELOPMENT OF RADIONUCLIDE DISCHARGE CRITERIA FOR THE OAK RIDGE SEWER SYSTEM

1.0 INTRODUCTION

The Oak Ridge Wastewater Treatment Plant receives radionuclides from state-licensed facilities, a local hospital, and the Department of Energy (DOE) Y-12 Plant. During treatment portions of the radionuclides are removed from the wastewater and incorporated in the treatment plant sludge. Radionuclide levels in the Oak Ridge sludge are relatively low. However, because there are no standards that establish "acceptable concentrations" in sludge, the presence of radioactive materials has been a continuing concern relative to the disposal of the Oak Ridge sludge through land application. To ensure the treatment plant sludge remains acceptable for land application, the City of Oak Ridge must limit discharges of radioactive materials to the sanitary sewer. As a first step, the City developed a methodology for determining acceptable radionuclide concentrations in sludge. The City worked closely with the Tennessee Department of Conservation development and obtained their written approval on the final report, Methodology for Establishing Radionuclide Limits for Land Application of the Oak Ridge Sludge. The City based its acceptable levels on limiting the radiation dose to a hypothetical, maximally exposed individual from land application to 4 mrem/year. This individual is assumed to establish residency and begin farming immediately following the last application of sludge. The resulting lifetime risk of fatal cancer from a 4 mrem/year dose rate over 70 years would be approximately 1 x 10-6 (one per million). This lifetime risk value was chosen because it is the target risk used by the U.S. Environmental Protection Agency (EPA) to develop limits for other carcinogens in sewage sludge. In this report, the "acceptable radionuclide concentrations in sludge" are used as a basis for limiting sewer discharges. Because the Oak Ridge Wastewater Treatment Plant is a Publicly Owned Treatment Works (POTW), as defined by the EPA, the City is required, under the Federal Clean Water Act, to limit any materials that are discharged to the sewer that may cause:

• Interference and/or inhibition of the operation of the treatment facility
• Pass through of toxic pollutants that adversely affect the quality of the receiving stream
• Contamination of the POTW sludge such that it is unfit for land application or landfill disposal .

In addition, the City must develop and administer an industrial pretreatment program to monitor and control waste discharges to the sewer system. Under the pretreatment program sewer discharges are limited by:

• Prohibited discharge limitations
• Categorical pretreatment limitations
• Local discharge limitations.

Prohibited discharge limitations are defined under 40 CFR 403, General Pretreatment Regulations, and address materials that are flammable, explosive, corrosive, or that, in some way, interfere with operation of the POTW. Categorical standards, which are established under 40 CFR 307(a) and (b), limit the quantities and concentrations of certain toxic pollutants that may be discharged by users that fall under specific industrial categories. When categorical standards do not exist or do not adequately protect the POTW, local discharge limits must be developed.

Task 8 Report: Development of Radionuclide 2 Discharge Criteria for the Oak Ridge Sewer As discussed in the Task 3 report, discharges of radioactive materials are regulated by the Nuclear Regulatory Commission and the Tennessee Division of Radiological Health. However, as pointed out in the Task 3 report, these regulations are not adequate because they do not address the potential for radionuclides to accumulate in sludge. 1.1 APPROACH TO LIMITING DISCHARGES There are two primary concerns that must be addressed when limiting discharges of radioactive materials to the Oak Ridge sewer. The quantities must be limited to ensure sludge levels remain acceptable for land application, and the concentrations must be limited to ensure treatment plant workers and personnel performing maintenance on the collection system are adequately protected. Discharges The methodology for establishing acceptable levels for land application is set forth in Methodology for Establishing Radionuclide Limits for Land Application of the Oak Ridge Sludge. This methodology which is based on limiting the radiation dose to a hypothetical, maximally exposed individual to 4 rnrern/year was used to calculate acceptable levels, or sludge limits, for those radionuclides that are currently discharged, and for others that may be discharged in the future (see Appendix A, Calculating Sludge Limits for Radionuclides). It should be noted that the Table A-2 sludge limit for each radionuclide was calculated on the basis of the 4 rnrern/year dose limit (i.e., as if it were the only radionuclide present in the sludge). If only one radionuclide were present in the Oak Ridge sewer system, the quantities discharged could be limited using the approach established for nonradioactive contaminants. First, the sludge limit would be used to calculate the allowable plant loading- the total quantity that can enter the plant over a given period of time- using the following formula: L = C; xMs! mi R.(l X 106 pC'. o µg) I µCz r g

        = allowable plant loading during time period t (µCi or g)

C; = radionuclide concentration limit in sludge (pCi/g or µg/g) Ms1 = mass of sludge removed from digesters during time period t (g) R; = fractional removal during treatment. Next, the allowable plant loading would be allocated among the existing dischargers, with a portion set aside for potential future dischargers. However, because several radionuclides are discharged to the Oak Ridge sewer this approach is not directly applicable. As discussed in the Methodology report, there are three primary radionuclides of concern from the standpoint of land application-Co-60, Cs-137, and uranium. To ensure the maximum annual dose from these radionuclides, and from others that may be discharged in the future, does not exceed 4 rnrern/year, the quantities of radionuclides discharged to the Oak Ridge sewer will be limited as described in section 1.2.3., below. In addition to meeting these criteria, sewer releases must also meet the pretreatment criteria in section 1.2.1, and the concentrations limits in section 1.2.2.

Task 8 Report: Development of Radionuclide 3 Discharge Criteria for the Oak Ridge Sewer 1.2 CRITERIA FOR SEWER DISCHARGES 1.2.1. Pretreatment Both State and Federal radiation protection standards are based on the hypothesis that the effects of radiation exposure are linearly related to dose with no threshold (i.e., there is some risk associated with any exposure and the risk increases with increasing dose). Therefore, it is prudent to minimize radiation exposures to the extent possible. The International Commission on Radiological Protection (ICRP) recommends that the risks be minimized by the following dose limitation system (ICRP 30 Report):

• no practice shall be adopted unless its introduction produces a positive net benefit
• all exposures shall be kept as low as reasonably achievable (ALARA), economic and social factors being taken into account
• the dose equivalent to individuals shall not exceed the applicable limits.

Implementation of the ALARA process has resulted in significant reductions in radiation exposures, and at this time is the primary means by which doses to workers and the public are limited in the U.S. (i.e., few individuals receive doses approaching the regulatory limits). In keeping with the ALARA principle, radionuclide levels in sewer discharges must not only meet the applicable criteria, but must also be kept as low as is reasonably achievable. Therefore, whenever possible, radioactive material dischargers will be required to pretreat their wastewater. The specific treatment process will be a condition of the wastewater discharge permit, but at a minimum should include filtration through a 0.45 µm filter to ensure that the material discharged is soluble. If a facility can, to the satisfaction of the City, demonstrate that pretreatment is not feasible, it will be permitted to discharge provided the concentration and quantity criteria in sections 1.2.2 and 1.2.3, below, are met. The facility must also demonstrate that their operating procedures are designed to minimize the introduction of radioactive materials into their sewer effluents to every extent reasonably achievable. 1.2.2. Concentration Limits To ensure treatment plant workers and personnel involved in maintenance and repair of the collection system are protected, the concentrations of radioactive materials discharged to the sewer will be limited to five times the derived concentrations guides (DCGs) for water listed in Appendix B. The table of DCGs in Appendix B was excerpted from DOE Order 5400.5, Radiation Protection of the Public and the Environment. 1.2.3. Maximum Annual Dose From Land Application Existing and proposed routine discharges will be evaluated on the basis of their contribution to the total annual dose from land application. A discharge, when combined with all other radioactive materials discharges, must not result in a total annual dose to the maximally exposed individual from land application greater than 4 rnrem/year. This evaluation will be accomplished using "discharge ratios" calculated as follows: DR= Maximum Monthly Discharge Quantity Allowable Monthly Plant Loading

Task 8 Report: Development of Radionuclide 4 Discharge Criteria for the Oak Ridge Sewer The sum of all the discharge ratios for each radionuclide from each discharger must be less than or equal to one. For example: Max. Monthly Qty. Max. Monthly Qty. Max. Monthly Qty. Max. Monthly Qty. of A from Facility X of B from Facility X of A from Facility Y of C from Facility Y

                        +                         +                         +--------~l Allowable Loading for A   Allowable Loading for B   Allowable Loading for A  Allowable Loading for C The methods for calculating the monthly, allowable plant loadings are discussed in Appendix C, Calculating Allowable Plant Loadings for Radioactive Materials. Values for Co-60, Cs-137, natural/depleted uranium and 2% enriched uranium are provided in Table C-1 of that Appendix.

The City will maintain a running total of the discharge ratios for routine releases to ensure the annual dose limit for land application is not exceeded. Nonroutine releases will also be evaluated using discharge ratios; however, they will be assessed on case-by-case basis and will not be included in the running total. For any given month the sum of the discharge ratios for routine releases and for nonroutine releases cannot exceed 1. 1.3 PERMITTING If a proposed discharge meets the above criteria, the facility will be issued a Wastewater Discharge Permit through the City's Industrial Pretreatment Program. The permit will specify the pretreatment criteria, monthly discharge quantity limits, and concentration limits for all radioactive materials discharged. If a facility is already permitted for discharges of nonradioactive materials, the existing permit will be modified to include the radioactive materials discharge criteria. Because the Pretreatment Program will now address radioactive materials, a new section, the "Radioactive Materials Questionnaire," was added to the City's Waste Water Survey for Nonresidential Establishments, Application for Waste Water Discharge Permit. The new section, which is provided in Appendix D, addresses the following information:

• types, forms, and quantities of radioactive materials used
• description of specific processes involving radioactive materials
• types, quantities, and concentrations of radioactive materials released to the sewer
• description of existing wastewater treatment processes
• description of safeguards for preventing inadvertent releases to the sewer The updated surveys were sent to all facilities on the Oak Ridge sewer system that hanclie unencapsulated radioactive materials to ensure the existing sources of radioactive materials discharges were identified and quantified.

Based on the responses to these surveys, there are currently three facilities that routinely discharge "measurable" quantities of radioactive materials to the Oak Ridge sewer-Quadrex Corporation (primarily Co-60 and Cs-137), Manufacturing Sciences Corporation (MSC) (depleted uranium), and the DOE Y-12 Plant (primarily slightly enricµed uranium). It should be noted that Y-12 does not intentionally discharge uranium to the Oak Ridge sewer system. The primary means by which uranium from the Y-12 Plant enters the sewer is believed to be infiltration of contaminated soils into the onsite sewer lines. For the purpose of quantifying releases and developing "discharge" criteria for Y-12, data from the City Station monitoring manhole, which includes both the Y-12 and MSC uranium contribution to the sewer, were used. It was necessary to use these data because, at present, there is not a sampling manhole that can be

Task 8 Report: Development of Radionuclide 5 Discharge Criteria for the Oak Ridge Sewer used to directly monitor Y-12 releases. Furthermore, discrepancies between Y-12's estimates of the MSC contribution at City Station (based on sampling of the Union Valley Industrial Park sewer line) and MSC's reported discharges (based on monitoring of batch discharges) make it difficult to determine the actual quantities of uranium entering the sewer from the Y-12 Plant. Y-12 is currently constructing a monitoring manhole which will allow a more accurate assessment of their releases in the future. The Quadrex, MSC and Y-12 sewer discharges are summarized in Table 2. Statistical analyses of these discharges are provided in Appendix E. The calculated mean monthly discharge plus one standard deviation was used as the facility specific discharge limits for these facilities (Table 3.) In the case of Y-12, for which sampling was performed one to four days each month, the average daily value plus one standard deviation was multiplied by 30 to calculate the monthly limit. Quadrex discharges were quantified over a two-year period from May 1991 to June 1993. Only three of the monthly Co-60 discharges and one of the monthly Cs-137 discharges exceeded the mean plus one standard deviation for this period. (i.e., the Table 3 limits). These elevated monthly discharges followed a period during which Quadrex was unable to discharge for several months due to construction on their wastewater treatment facility. Therefore, under normal operating conditions Quadrex should have no problem meeting the limits specified in Table 3. In the case of MSC, discharges were evaluated from August 1991 to August 1993. During this period, MSC's discharges decreased steadily and after February 1992 remained below the Table 3 limit. The facility specific discharge limits in Table 3 were used to calculate discharge ratios (also provided in Table 3) using the method described above. The resulting "sum of the discharge ratios" was 0.52 Table 2. Summary of Existing Radioactive Materials Discharges Minimum Maximum Average Radioactive Monthly Monthly Monthly Facility Material Discharge Discharge Discharge Quadrex Co-60* 0 µCi 216 µCi 68 µCi Cs-137* 0 µCi 62 µCi 12 µCi MSC Nat/Depleted U* 6g 31 g 16 g DOEY-12 2%-enriched U** *

• 470 g

 *Based on reported discharges from 1991 through 1993
 ** Based on measurements by the Y-12 Plant at City Station monitoring manhole in 1991 (i.e., includes Union Valley Ind. Park (MSC) contribution). Sampling consisted of 24-hour composites collected one to four days each month. Average monthly= average grams/day x 30 days/month.

SUMMARY

Under the Federal Clean Water Act and the Tennessee Water Pollution Control Act, the City of Oak Ridge is required to establish protection criteria for its POTW to "prevent contamination of its sludge such that it is unfit for land application or landfill disposal." In the absence of state or federal standards for radioactive materials in sludge, the City developed its own methodology for establishing acceptable levels of radionuclides in their treatment plant sludge. I

Task 8 Report: Development of Radionuclide 6 Discharge Criteria for the Oak Ridge Sewer Table 3. Calculated Facility Specific Discharge Limits and Discharge Ratios Facility Radioactive Material Discharge Limit Discharge Ratio Quadrex Co-60 130 µCi 0.271 Cs-137 30 µCi 0.007 MSC Nat/Depleted U 25 g 0.002 DOE Y-12 2%-enriched U 840 g 0.24 SUM= 0.52 The City developed its acceptable levels, or sludge limits, based on limiting the radiation dose to the maximally exposed individual from land application to 4 mrem/year. In this report, the sludge limits are used as a basis for evaluating and limiting the quantities of radioactive material discharged to the Oak Ridge sewer. In addition, pretreatment criteria and concentration limits for sewer discharges are established. The criteria established in this report will be implemented through the City of Oak Ridge's existing Industrial Pretreatment Program.

Task 8 Report: Development of Radionuclide 7 Discharge Criteria for the Oak Ridge Sewer REFERENCES Environmental Protection Agency (1986). "Radioactivity of Municipal Sludge." Office of Water Regulations and Standards, Wastewater Solids Criteria Branch. Stetar, E.A. (1992) Memo to Bob Dominak on Radioactive Contamination in Municipal Wastewater Treatment Plants. Northeast Ohio Regional Sewer District, 3826 Euclid Avenue, Cleveland, Ohio. Stetar, E.A., H. L. Boston, LL. Larsen, and M.H. Mobley (1993). The removal of radioactive cobalt, cesium, and iodine in a conventional municipal wastewater treatment plant; Water Environ. Res., 65, 630-639.

Appendix A, Task 8 Report: Development of Radionuclide A-1 Discharge Criteria for the Oak Ridge Sewer APPENDIX A

Appendix A, Task 8 Report: Development of Radionuclide A-2 Discharge Criteria for the Oak Ridge Sewer CALCULATING SLUDGE LIMITS FOR RADIONUCLIDES The methodology for establishing "acceptable" radionuclide concentrations in the Oak Ridge sludge was set forth in Methodology for Establishing Radionuclide Limits for Land Application of the Oak Ridge Sludge. First, the RESRAD code is used to calculate soil guidelines that correspond to a 4 mrem/year dose limit to the maximally exposed individual from land application. These soil guidelines are then converted to acceptable sludge concentrations, or sludge limits, using the appropriate dilution factor. RESRAD based soil guidelines for 11 radioactive materials are presented in Table A-1. Calculation of the guidelines for natural/depleted and 2%-enriched uranium, using the RESRAD dose-source ratios (mrem/year per pCi/g-soil), is discussed below. It should be noted that each of the soil guidelines corresponds to the 4 mrem/year dose limit. The soil guidelines in Table A-1 were converted to acceptable sludge concentrations, or sludge limits, using a dilution factor (DF) of 5.6 x 10-2: Soil Guideline Sludge Limit = DF The DF is based on the assumptions that 1) the sludge is applied at a rate of 4 tons/year for 15 years and 2) the sludge is uniformly mixed with soil to a depth of 0.15 m. Because no credit was taken for radioactive decay or loss due to leaching and weathering during the 15 year application period, the dilution factor is appropriate for any application rate provided the total cumulative loading per acre does not exceed 60 tons. The calculated sludge limits are provided in Table A-2. It should be noted that each of these sludge limits corresponds to a 4 mrem/year dose limit. If more than one of the radionuclides is present a "sum of the ratios" approach should be applied to ensure the maximum annual dose does not exceed 4 mrem. Table A-1. RESRAD Soil Guidelines for Individual Radionuclides Based on 4 mrem/year Dose* Radionuclide Concentration (pCi/g-dry wt)** Am-241 9.0 Cs-134 0.70 Cs-137 1.5 Co-60 0.35 Mn-54 1.3 Ra-226 0.46 Sr-90 8.9 Th-232 2.8 2%-Enriched Uranium 14ppm Natural and Depleted Uranium 36ppm

• Each soil guideline corresponds to a 4 mrem/year dose limit.

              ** Units are oCi/g-drv wt. unless otherwise specified.

Appendix A, Task 8 Report: Development of Radionuclide A-3 Discharge Criteria for the Oak Ridge Sewer Table A-2. Sludge Limits for Individual Radionuclides* Radionuclide Concentration (pCi/g-dry wt)** Am-241 160 Cs-134 13 Cs-137 27 Co-60 6.3 Mn-54 23 Ra-226 8.2 Sr-90 160 Th-232 50 2%-Enriched Uranium 250ppm Natural and Depleted Uranium 640ppm

              *Each value corresponds to a 4 mrem/year dose from controlled land application to a total cumulative loading of 60 tons/acre with a mixing depth of 0.15 m. If more than one radionuclide is present in the sludge, a "sum of the ratios" approach should be used to ensure the total dose limit is not exceeded.
              ** Units are oCi/g-drv wt. unless otherwise specified.

Uranium Soil Guidelines RESRAD calculates soil guidelines and dose-source ratios (mrem/year per pCi/g-soil) for the individual uranium isotopes U-238, U-235, and U-234. As discussed in the Methodology report, the dose-source ratios can be used in the following formula to calculate soil guidelines for mixtures of these nuclides. The formula can be used for natural, depleted or enriched uranium, provided the isotopic ratios are known so that the appropriate substitutions can be made. (U-234 Concentration x 0.11 mrem/yr) + (U-235 Concentration x 0.63 mrem/yr) pCi/g pCi/g

     + (U-238 Concentration x 0.17 mrem/yr) = 4 mrem/yr pCi/g The activity ratios for natural uranium are U-234/U-238 = 1 and U-235/U-238 = 0.046. Using these activity ratios and the corresponding substitutions:

U-234 concentration= U-238 concentration U-235 concentration= U-238 concentration x 0.046, a natural uranium soil guideline of 25 pCi/g (36 ppm) was calculated. For depleted uranium (< 0.7% U-235), the soil guideline will be slightly higher than the natural uranium value. However, for simplicity, and because the isotopic ratios are often not known for depleted uranium, the more conservative natural uranium value was also used as the depleted-uranium soil guideline.

Appendix A, Task 8 Report: Development of Radionuclide A-4 Discharge Criteria for the Oak Ridge Sewer For enriched uranium(> 0.7% U-235), the soil guideline should be lower than the natural uranium value. The actual guideline value depends on the level of enrichment, with the guideline decreasing as the level of enrichment increases. At this time, the only known discharges of enriched uranium to the Oak Ridge sewer are from the Department of Energy's Y-12 Plant. In 1991, their discharges ranged from 0.4% U-235 (depleted) to 2.7% U-235 (enriched) with an average of roughly 1%, and thus far in 1993, the Y-12 discharges have ranged from 0.85 to 3.4% with an average of 1.4%. Assuming an enrichment level of 2% and activity ratios of U-234/U-238 = 4 and U-235/U-238 = 0.13, an enriched uranium soil guideline of 24 pCi/g (14 ppm) was calculated.

Appendix B, Task 8 Report: Development of Radionuclide B-1 Discharge Criteria for the Oak Ridge Sewer APPENDIX 8 Cha.f'te,'L_j_LJ_ 1 Do~ OiP-c(Je,L S-~00. s-) Oe..,4.; ve/. L-o;.1ce.;v k~*ffo,J G~cfeI

                                  /I/OT         .LNCLu.O£D

Appendix C, Task 8 Report: Development of Radionuclide C-1 Discharge Criteria for the Oak Ridge Sewer APPENDIX C

Appendix C, Task 8 Report: Development of Radionuclide C-2 Discharge Criteria for the Oak Ridge Sewer CALCULATING ALLOWABLE PLANT LOADINGS FOR RADIOACTIVE MATERIALS The allowable plant loadings, for the Oak Ridge Wastewater Treatment Plant, for Co-60, Cs-137, natural/depleted uranium, and 2%-enriched uranium are provided in Table C-1. These are the values that will be used in the calculation of discharge ratios. With the exception the 2%-enriched uranium value, the Table C-1 allowable loadings were calculated on the basis of limiting the concentrations in the digested sludge to the Appendix A sludge limits. The methodology used for these calculations is described below, in section C.2, "Allowable Loadings Based on Appendix A Sludge Limits." The methodology used for calculating allowable loadings for 2-% enriched uranium and special nuclear materials is described in section C. l. A 25% safety factor was included in the calculation of the allowable plant loadings in Table C-1 (i.e., the values were reduced by 25%). This safety factor was necessary to compensate for uncertainties such as:

• potential unidentified sources of radioactive materials
• inherent uncertainties associated with measurements of radioactivity
• errors in flow or volume estimates for discharges
• potential changes in plant operating conditions that may affect radionuclide removals.

C.1. Allowable Loadings for Special Nuclear Materials For special nuclear materials, such as enriched uranium, it is not only the sludge concentration that must be considered. In addition, the total quantity of the fissionable material present in the treatment plant at any given time must be limited. Under the Atomic Energy Act, quantities of special nuclear material greater than those listed in Table C-2 must be licensed by the federal government (i.e., licensed by the Nuclear Regulatory Commission (NRC) under a Special Nuclear Materials License). To ensure the Oak Ridge treatment plant is not subject to NRC licensing, the allowable plant loading for special nuclear materials will be established such that the total quantities present in the treatment plant at any one time do not exceed the quantities in Table C-2. The two compartment model shown in Fig. 1 will be used to determine the plant loadings that correspond to these quantities. In addition, the allowable loadings will be calculated based on the Appendix A sludge limits. These plant loading values will be compared to those obtained with the model, and the more restrictive of the two will be used as the basis for limiting sewer discharges. Table C-1. Lm - Individual, Allowable Monthly Plant Loadings for Selected Radioactive Materials Radionuclide Lm Co-60 480 µCi Cs-137 4050 µCi Natural or Depleted Uranium 16,000 g 2%-enriched Uranium 3450 g

• If more than one radionuclide present, the "sum of the ratios" must not exceed one.

Appendix C, Task 8 Report: Development of Radionuclide C-3 Discharge Criteria for the Oak Ridge Sewer Table C-2. Maximum Quantities of Fissionable Materials That Can be Possessed Without a Federal SNM License Uranium enriched in U-235 350 g contained U-235 Uranium-233 200g Plutonium 200 g

• If more than one special nuclear material is present, the "sum of the ratios" must not exceed one.

Fig. 1. Two Compartment Model with Flow Through Where I is the input to the sludge, q1 is the quantity of the fissionable material in the primary and secondary treatment sludges, and q2 is the quantity in the primary and secondary digester sludges. The loss rate constants, k1 and k2, were derived from data obtained during a radiotracer study conducted at the Oak Ridge plant in 1990 (Stetar, et al., 1993). The allowable plant loading can then be calculated as follows: L=.!._(SFR)

    ~

I = Input to sludge (g/unit time) Ri = fractional removal during treatment SFR = safety factor reduction-(0.75) for 25% reduction Using the spreadsheet calculations in Table C-3, the maximum allowable input of U-235 to the treatment plant was estimated to be 2.3 g/day or 70 g/month. This monthly quantity of U-235 corresponds to a monthly allowable plant loading for 2%-enriched uranium of 3450 g. For comparison, the allowable plant loading for 2%-enriched uranium calculated on the basis of limiting the sludge concentration to 250 ppm is 6250 g. For calculation of the U-235 allowable plant loading a fractional removal of 0.9 was assumed. The basis for this assumption is provided below, in section C.2., subsection Ri-Fractional Removal During Treatment.

Appendix C, Task 8 Report: Development of Radionuclide C-4 Discharge Criteria for the Oak Ridge Sewer C.2 Calculating Allowable Loadings Based on Appendix A Sludge Limits The following formula was used to calculate the allowable loading values for Co-60, Cs-137, and natural/depleted uranium which are listed in Table C-1: L. = C; xMs! (SFR) m, R.(l X 106 pC'. µg)

                                             ,         µC1 or g L,. = allowable plant loading during time period t (µCi or g)

I C; = Concentration limit in sludge (pCi/g or µg/g) Ms 1 =mass of sludge removed from digesters during time period t (g) R; = fractional removal during treatment. SFR = safety factor reduction-(0.75) for 25% reduction Ci-Concentration Limit in Sludge The sludge limits in Table A-2, Appendix A, were used in the calculations of the allowable plant loadings. Ms[ - Mass of Sludge Removed from Digesters Monthly A period of one month was chosen for calculating the allowable plant loadings because the radionuclides are assumed to mix within at least a 30-day sludge volume prior to removal from the plant for land application. This assumption is based on the following:

• the retention time for solids in the plant is approximately 70 days
• the sludge undergoes significant mixing within the treatment plant
• peak concentrations have been observed in the digested sludge approximately 30 days following a pulse input (Stetar et al., 1993).

Approximately 400 dry tons (3.6 x 108 g) of sludge are removed from the Oak Ridge treatment plant digesters each year. For these calculations, it is assumed that the sludge was removed a constant rate of 3 x 107 g/month. Ri - Fractional Removal During Treatment Fractional removal values for cobalt and cesium in the treatment plant were determined to be approximately 0.30 and 0.15, respectively, during a radiotracer study performed in 1990 (Stetar, et al. 1993). In this study soluble radioactive cobalt and cesium were mixed in the treatment plant influent and allowed to equilibrate for 4 hours. The equilibration period was designed to allow representative partitioning of the tracers between the solid and liquid phases of the wastewater. A 4-hour period was chosen because it approximates the average transit time for radionuclides discharged into the Oak Ridge sewer. Soluble tracers were used because the Co-60 and Cs-137 discharged to the Oak Ridge sewer are primarily soluble. The largest contributor of Co-60 and Cs-137 to the Oak Ridge sewer is required by their Tennessee Radioactive Materials license to pass all sewer discharges through a 0.45 µm filter prior to release. Furthermore, the City's pretreatment criteria, specified in section 8.2.1 of this report, will require radioactive materials discharges to be filtered through 0.45 µm filters.

Appendix C, Task 8 Report: Development of Radionuclide C-5 Discharge Criteria for the Oak Ridge Sewer The mean fractional removal for uranium was estimated to be 0.6 based on measurements of plant influent and effluent concentrations made over 5 consecutive days in 1991 by DOE Y-12 plant personnel (DEUSS 1991). The daily removals over this time period ranged from 0.5 to 0.9. These values were calculated using the following formula: I-E R=-- I R = fractional removal

   /    =influentconcentration E    = effluent concentration The errors associated with the Y-12 measurements are not known. However, because the influent and effluent concentrations were very low, on the order of 0.004 mg/1, the errors are assumed to be significant. Considering this uncertainty, the maximum observed removal of 0.9 (i.e., the most conservative) was used in the plant loading calculations.

Background Radionuclide Concentrations in Sludge Uranium is a naturally occurring radioactive material that is present in all soils in varying quantities. Low levels of Cs-137 and Co-60 (both man-made radionuclides) are also present in soils, primarily as the result of previous nuclear weapons testing. Because these radionuclides are present in the environment, they are also found in wastewater treatment plant sludges, usually at very low concentrations. To determine the background concentrations of Co-60, Cs-137, and uranium for the Oak Ridge sludge, samples of sludge from five other East Tennessee communities with no known sources of radionuclides-Lenoir City, Knoxville, Maryville, Morristown, and Sevierville-were collected and analyzed for gamma emitting radionuclides (Oak Ridge National Laboratory) and for total uranium (TMA Eberline, Oak Ridge). No detectable levels of Co-60 were found in the sludges from these municipalities (minimum detectable activity""' 0.06 pCi/g-dry wt). Cs-137 was present in the sludges at concentrations ranging from 0.05 to 0.2 pCi/g-dry wt. with a mean of approximately 0.1. Low levels of uranium, presumably at natural ratios, were also present in the sludge samples. The mean value for uranium was approximately 3 ppm. Because the background levels were all well below 1% of the sludge limits in Table A-2, they were not considered in the land application dose assessment or the allowable plant loading calculations.

Table C-3. Model for limiting discharges of fissionable materials ql= quantity in primary and secondary sludges (grams) q2= quantity in digester sludges (grams) I= input rate to WWTP (grams/day) (assumed to be constant) Model differential equations: dql/dt = I - klql and dq2/dt = qlkl - k2q2 Solutions: ql = 1/kl(l-exp(-kl *t)) + ql(0)*exp(-kl *t) -*- - - - - - - - - - - - - -i- - - - - - -r- ----- --- ---- -- --- -- q2 = l/k2 (1-exp(-k2*t)) + ((ql(0)*kl-l)/k2-kl)(exp(-kl *t) - exp(-k2*t)) + q2(0)*exp(-k2*t)

                   ~

Calculations for U-235: ql + q2 :,; 350 g I (g/day) = 2.80 Allowable plant loading, L = 1/R(SFR) kl(l/day)= l.37E-01 I= constant input rate to WWTP (grams/day) k2 (1/day)= 8.50E-03 R = fractional removal during treatment, 0.9 assumed ql(0)= 0.00 SFR = safety factor reduction (0. 75) q2 (0) = 0.00 L (U-235)=2.3 $day, L(2%-enr.U)=115 g/day (3450 g/mo) Demonstration: time (days) ql q2 ql+q2 0 0 0 0 30 20 58 78 60 20 119 139 90 20 166 186 120 20 203 223 150 20 231 252 180 20 253 274 210 20 270 291 240 20 284 304 270 20 294 314 300 20 302 322 330 20 308 329 360 20 313 333 390 20 317 337 420 20 320 340 450 20 322 342 480 20 323 344 510 20 325 345 540 20 326 346 570 20 327 347 600 20 327 348 630 20 328 348 660 20 328 349 690 20 328 349 720 20 329 349 750 20 329 349 780 20 329 349 Equilibrium Quantity of U-235 With Constant Input of 2.8 Grams/Day 350 - *

                                                             -~~

300

   §      250
                                                                   - - - - - - q1
   .?;- 200

- - - q2 C

150

('II

I 0 100 ------ q1+q2 50 0

                 ~------       ************                      *********

000000000000000000000000000 M©mN~ro~v~0M©mN~ro~v~0M©mN~OO

                          ~~~NNNMMMMvvv~~~©©©©~~~

time (days)

Appendix C, Task 8 Report: Development of Radionuclide C-6 Discharge Criteria for the Oak Ridge Sewer

Appendix C, Task 8 Report: Development of Radionuclide C-7 Discharge Criteria for the Oak Ridge Sewer REFERENCES Stetar, E.A., H. L. Boston,J.L. Larsen, and M.H. Mobley (1993). The removal of radioactive cobalt, cesium, and iodine in a conventional municipal wastewater treatment plant; Water Environ. Res., 65, 630-639.

Appendix D, Task 8 Report: Development of Radionuclide D-1 Discharge Criteria for the Oak Ridge Sewer APPENDIX D

Appendix D, Task 8 Report: Development of Radionuclide D-2 Discharge Criteria for the Oak Ridge Sewer Radioactive Materials Questionnaire Attach additional sheets as needed.

1. Indicate which of the following radiation protection criteria your firm is subject to:

State of Tennessee Standards for Protection Against Radiation (SRPAR) _ _ _ _ _ _ _ _ _ _ _ _ __ Nuclear Regulatory Commission Department of Energy (DOE) Orders Other, specify

2. List all radioactive materials related licenses/permits:

Permit Name and No. Issuing Agency Do any of these permits contain limits (other than those specified in the above radiation protection criteria) for discharges of radioactive materials to the sewer? [ ] Yes [ ] No If yes, please list these limits in the space provided or attach a copy: Radioactive Material Limit (include units)

Appendix D, Task 8 Report: Development of Radionuclide D-3 Discharge Criteria for the Oak Ridge Sewer

3. Indicate the types, forms, and quantities of radioactive materials that are typically present at your facility/facilities:

Radioactive Form Quantity Material (Solid, Liquid, Gas) (Ci)

4. Briefly describe each process that involves radioactive material:

5. Does your firm discharge measurable amounts of radioactive material (including samples containing radioactive material) into the sewer?

[ ] Yes [ ] No If Yes, indicate the quantities discharged on a monthly basis for the last two years: Month/Year Radioactive Material Quantity Discharged (µCi)

Appendix D, Task 8 Report: Development of Radionuclide D-4 Discharge Criteria for the Oak Ridge Sewer

6. Is your wastewater treated to remove radioactive materials prior to discharge t9 the sewer?

[ ] Yes [ ] No If Yes, describe the treatment processes used and attach drawings of your existing treatment facilities.

7. Describe any safeguards that are in place at your facility to prevent inadvertent releases of radioactive materials to the sewer.

Appendix E, Task 8 Report: Development of Radionuclide E-1 Discharge Criteria for the Oak Ridge Sewer APPENDIX E

Appendix E, Task 8 Report: Development of Radionuclide E-2 Discharge Criteria for the Oak Ridge Sewer X1  : Quadrex Monthly Co-60 (µCi) Mean: Std. Dev.: Std. Error: Variance: Coef. Var.: Count: I60.046 165.214 I 14.582 14252.846 195.837 120 Minimum: Maximum: Ran e: Sum: Sum of S r.: # Missin 0 215.6 215.6 1360.93 173410.597 6 - Mean: 1.12.253 Minimum: I Std. Dev.: 16.306 Maximum: X2  : Quadrex Monthly Cs-137 (µCi) Std. Error: 13.646 Rane: Variance: I265 .. 881 Sum: Coef. Var.: I133.073 Sum of S r.: Count: 120

                                                                                        # Missin 0                   62.31            62.31             245.066       8054.625     6 X3     : MSC Monthly Uranium (g)

Mean: Std. Dev.: Std. Error: Variance: Coef. Var.: Count: 116.212 16.928 11.386 147.995 142.732' 125 Minimum: Maximum: Ran e: Sum: Sum of S r.: # Missin 6.329 31.176 24.847 405.302 7722.658 1 X4  : Y-12 Daily Uranium (g) Mean: Std. Dev.: Std. Error: Variance: Coef. Var.: Count: I15.808 I 12.047 12.363 1145.122 176.207 126 Minimum: Maximum: Rane: Sum: Sum of S r.: # Missin 3 56 53 411 10125 0

Appendix E, Task 8 Report: Development of Radionuclide E-3 Discharge Criteria for the Oak Ridge Sewer Quadrex Co-60 Monthly Discharges (µCi) 225--------------------- 200 175 150

                     ********************************************************************************************************************** +1sd 125                                                     
          ~ 100                     
                       ......__ _ _ _ _ _ _ _ _ _ _ _ _ _ _-iµ 75 ..............

50 25 o o 0 ***********************

                                                                                                                                 ********** -1 sd
               -25..__ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ ___._

Observations- May 1991 to June 1993 Quadrex Cs-137 Monthly Discharges (µCi) 70---------------------.- 60 50 40 Ii Ii

            ~    3 0 *,******************************************************************************************************************** + 1 sd 20 Ii                                                                   Ii
               -10.._     _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ ___ -1 sd Observations- May 1991 to June 1993

Appendix E, Task 8 Report: Development of Radionuclide E-4 Discharge Criteria for the Oak Ridge Sewer MSC Uranium Monthly Discharges (g) 35-.--------------------- 30 <> 25 <> (/)

                         ******-<>***************°-**************************************************************************************************** + 1sd E                                <>

e C) 20 <> <>

                                                                            .A.      <>                                                                 µ 15 V'

0 <> <> <> 10 °<> <>

                         ****************************************************************************************************o***************-<>******  -1 s d 5..1...--_ _ _ _ _ _ _ _ _ _ _ _ _ _ <>                                                           ___           <>o  _ __.

Observations-August 1991 to August 1993 Y-12 Uranium Daily Discharges (g) 60-.------------------- 0 50 40 0 0 (/) E 30 e C)

                           ******O*.*********************************************************************************************************** + 1 sd 20                             0        0                00               n                          f"'I V                                                                     U                               µ O           Oo                                                           0 1 O*                      0                                      00                    0                  0           O
                            *************************************Q .......... ********* ...... 20************ ... ***********o****** -1 sd 0..L.--------------------'-

Observations-1991

Appendix E, Task 8 Report: Development of Radionuclide E-5 Discharge Criteria for the Oak Ridge Sewer X1  : Quadrex Monthly Co-60 (µCi)

      # < 10th %:         10th %:        25th %:            50th %:       75th %: 90th %:

I 1.47 117.36 139.305 1111.55 I112.95

      # > 90th %:

- # < 10th %: lo

      # > 90th %:

10th %: lo X2 :Q uadrex Monthly Cs-137 (µCi) 25th %: 1 .67 7 50th %: 15.184 75th %: l1a.59 90th %: 134.93 12 I I I X3  : MSC Monthly Uranium (g)

      # < 10th %:         10th %:        25th %:            50th %:       75th %: 90th %:

12 16.916 I10. 797 120.534 125.722

      # > 90th %:

- 12 I I X4  : Y-12 Daily Uranium (g)

      # < 1oth %:         10th %:        25th %:            50th %:       75th %: 90th %:

Is 15.1 la ls5.3

      # > 90th %:

Is I I

Appendix E, Task 8 Report: Development of Radionuclide E-6 Discharge Criteria for the Oak Ridge Sewer Box Plot 225 0 200 0 I 175* 150 125 100 75 50 25 0

                 -25 Quadrex Co-60 Monthly Discharges (µCi)

May 1991 to June 1993 I Box Plot 70 0 60 50 40* 0 30 20 10 0

                  -1 0 Qua drex Cs-137 Monthly Discharges (µCi)

May 1991 to June 1993

Appendix E, Task 8 Report: Development of Radionuclide E-7 Discharge Criteria for the Oak Ridge Sewer Box Plot 35 0 30 0 25 20 15 10 5 MSC Uranium Monthly Discharges (g) August 1991 to August 1993 Box Plot 60 0 50 40 _Jl,._ 30* 20 1 O*

                                                        -                                                             0 0

Y-12 Uranium Daily Discharges Uranium (grams)

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Paper*---------------

DISCOVERY OF A 137Cs HOT PARTICLE IN MUNICIPAL WASTEWATER TREATMENT SLUDGE Ingvar L. Larsen,* S. Y. Lee,* H. L. Boston* and E. A. Stetart dried, resuspended, and translocated by wind erosion. Abstract-Analysis of primary treatment sludge from a mu- Depending on their size, smaller particles (~ <5 µm) nicipal wastewater treatment plant revealed elevated mes associated with dried sludge may enter the respiratory concentrations in one sample. This elevated activity was as- tract through inhalation, whereas larger ones may be sociated with a radioactive particle that, when isolated and ingested when associated with food products. quantified, was found to contain 1.82 kBq of mes. Additional analysis indicated an absence of alpha activity, and energetic Detecting a particle containing 1.82 kBq of 137 Cs beta radiation, if present, was less than the mes activity. The isolated from a sample of primary treatment sludge particle was approximately 50 µm in diameter, appeared not from a local wastewater treatment plant is considered to be an aggregate, and was nonmetallic. unusual because samples of this intermittently collected Health Phys. 62(3):235-238; 1992 fluid, prior to and followin~ this particular sample, did Key words: 137 es; radiation, gamma; bremsstrahlung; water not reveal salient levels of 1 7Cs (Table 2). The elevated 137 treatment Cs content of this sample triggered an investigation into its cause of high radioactivity and possible sources. INTRODUCTION MATERIALS AND METHODS SEVERAL industries served by the Oak Ridge, TN, san- As part of a tracer experiment to investigate the itary sewage plant dispose of treated radioactive waste- fate of certain radionuclides entering into the Oak water, under state regulation, directly into the system. Ridge wastewater treatment plant, 1-L samples of pri-The sewage system also receives radionuclides used in mary treatment sludge were collected from a sampling medical applications as waste from patients that had valve located on the transfer line between the primary been inoculated for medical treatment. In addition, settling tanks and the anaerobic digesters and placed naturally occurring and fallout radionuclides enter t_he directly into Marinelli beakers. Sampling was per-sanitary system through storm runoff. These rad10- formed intermittently over 25 d, and samples were nuclides usually enter the system in liquid (soluble) counted in the beakers by using an intrinsic germanium form but may become associated with particulate mat- (IG) detector (relative efficiency at 1332 ke V of 25% ter or may become insoluble and nonexchangeable and an FWHM of 2.0 ke V). Essentially the same tech-during treatment. Insoluble forms are removed from nique described by Larsen and Cutshall ( 1981) was the wastewater and become concentrated in the anaer- used to calibrate the detector. obic digested sludge. This sludge is then extracted from During the analysis of the primary treatment the plant and utilized in soil fertility investigations. sludge, one sample (D, Table 2) became suspect when Table 1 is a listing of the radionuclides that we the 137 Cs activity exceeded the other values by more observed through almost weekly monitoring of this than two orders of magnitude. Recounting the sample sludge from the local municipal wastewater trea_tment after shaking produced an additional anomalous high plant. Disposing of the accumulated contaminated value but of differing concentration, indicating non-sludge may become problematic. Boston et al. ( 1990) homogeneity. The presence of a "hot particle" was have summarized the fate of radioactivity associated suspected because such results could be obtained by a with sludge application for local soil fertility improve- particle in different locations with respect to the ~etec-ment. tor. Since the beakers had been washed and nnsed Radioactive particles present in land-surface-ap- before use, this eliminated the occurrence of prior plied sludge may present a potential health hazard when contamination.

• Environmental Sciences Division, Oak Ridge National Labo- To isolate the radioactive particle, the sample was ratory, Oak Ridge, TN 37831-6036; 1 Department of Radiological repeatedly divided, and each portion was analyzed for Health Sciences, Colorado State University, Fort Collins, CO 80523 . 137 Cs. Analyses suggested that only one such "hot par-(Manuscript received 15 July 1991 ; revised manuscript receii*ed I November 1991 , accepted 16 November 1991) ticle" was present. After much effort, near-final sepa-00 I 7-9078/92/ $3.00/0 ration was accomplished by pipetting approximately 5 Copyright © 1992 Health Physics Society mL of the remaining solution-containing particles into 235

236 Health Physics March 1992, Volume 62, Number 3 Table 1. Annual 1990 mean radionuclide concentrations in kBq ( 1er) was determined. A second analysis performed liquid anaerobic digested sludge* from the Oak Ridge waste- elsewhere at Oak Ridge National Laboratory provided water treatment plant.b a value of 1.79 +/- 0.063 kBq. A weighted (reciprocal of Probable the variance) mean value of 1.82 +/- 0.057 kBq was Radionuclide Half-life CBq kg-I origind obtained for the particle. rnr 8.04 d 6.2 (42) M Absence of an observable bremsstrahlung spec-201TI 3.04 d 2.0 (5) M trum (Fig. 1) during gamma analysis with the un-137 Cs 30.2 y 2.5 (48) W, I 6oco 5.27 y 3.1 (48) I shielded hot particle near the face of the IG detector 238ue 4.47 X 109 y 12.8 (10) I,N indicated a lack of any predominant energetic beta 7 Be 53.3 d 2.0 (27) W,N emitters (i.e., 90 Sr-90 Y). This technique, however, is not 40K 1.28 X 109 y 6.7 (48) N sensitive to low levels of beta activity. A considerable 226Ra i.60X 103 y 1.1 (48) N amount of energetic beta activity must be present to 22sRa 5.75 y I.I (42) N manifest itself above the Compton continuum pro-

• One kilogram ofliquid sludge provides 22 g of dry solids. duced by the hot particle.

b Radionuclide concentrations fluctuate considerably depending on disposal intensity and periodicity. An estimation of the beta activity needed to be c Numbers in parentheses refer to the number of samples in which detectable was made by using the lower limit of detec-the particular radionuclide was detected in 48 weekly samples. tion (LLD) concept described by Pasternack and Harley d M = medical applications; I = industrial; N = naturally occurring; (1971 ). By treating the mes Compton continuum re-and W = atmospheric washout/soil runoff. gion below the backscatter peak where the bremsstrah- ' Determined by activation analysis. lung radiation predominates (channels 0-372) as a "noise level," a lower limit of detection was estimated for the 90 Sr- 90 Y contributions. A 90 Sr-90 Y source was a 20-mL vial and counting for verification. Further counted in a similar geometry as the hot particle, and separation was accomplished by pipetting 1-mL ali- the net count rate was determined. From the known quots of this solution along with rinses into plastic, source activity, the efficiency of counting in this mode circular (47 mm diam.) containers (~15 cc capacity) was determined to be 0.46% (cps/dps). Given a 300-s and counting each container to determine which one counting period for the hot particle and integrating the contained the hot particle. acquired counts between channels 0-372 of the spec-The container with the hot particle was partially trum, some 14,080 counts were obtained. Using a 4.65 covered and allowed to air dry undisturbed for approx- confidence interval (Pasternack and Harley 1971 ), the imately 70 h. The location of the hot particle was LLD was calculated as follows: determined by placing a lead sheet with a small pencil- LLD = (4.65)(14,080 counts)11' = _ 400 Bq. I) point hole over a beta/gamma survey probe and search- (300 s)(0.0046 cps/dps) ing for the area of high activity within the container. This area was then marked on the outside bottom of In the presence of the Compton continuum (channels the container, and the particles in this region were removed by pressing cellophane tape over the area, transferring it to another similar container, and re-counting. At this point, the mes activity was quantified by counting the container 1 m centrally above the IG detector and comparing the observed count rate to that 1000 of a mes point source of known activity in a similar container at the same position. A value of 1.98 +/- 0.14

                                                                        ~
                                                                        ~ 100 0

u 137 Table 2. Cs concentration in a primary intake fluid from a local wastewater treatment plant, 24 and 25 May 1990. Sample Time 137 Cs (Bq kg- 1) 10 24May A 02:40 1.2 +/- 0.4 B 09:45 Not detected C 10:30 1.5 +/- 0.6 D 17:30 690 +/- 6.8 0 250 500 750 1000 1250 1500 1750 2000 2250 D After shaking 2650 +/- 6.8 CHANNEL E 18:10 0.9 +/- 0.3 Fig. 1. Gamma-ray spectrum of 137 Cs particle isolated from 25May primary treatment sludge (23-s counting interval). Insert is a F 01:20 0.8 +/- 0.3 90 Sr-90 Y bremsstrahlung spectrum using a 621-Bq source and G 10:45 0.8 +/- 0.5 counted for 6000 s.

137Cs in wastewater treatment sludge

• I. L. LARSEN ET AL. 237 0-372) resulting from the hot particle, some 400 Bq or more of 90Sr-<X>y would have to be present to attribute counts in this region to something other than mes interaction. Conversely, beta activity less than ~400 Bq could not be distinguished from the variability associ-ated with the Compton continuum.

We also examined the ratio of the integrated counts in this Compton region to* the mes photopeak counts of the hot particle for five replicate determinations, with an average ratio of 0.8983 +/- 0.0153 (lo). This value was virtually the same for five determinations made using a 137Cs source in a similar geometry, with a mean of 0.9033 +/- 0.0091. If appreciably energetic beta radiation was present, the ratio resulting from the hot-particle spectrum should be higher due to contri-butions from bremsstrahlung radiation. Based on the above analysis, if energetic beta radiation was present, its magnitude was less than that of mes activity. Fig. 2. A scanning electromicrograph (l l 80x) showing a The particle also was analyzed for alpha activity cylindrical-shaped radioactive particle of nonmetallic origin. using a portable alpha survey meter with a zinc sulfide window. By placing the probe directly over the particle, a gross count rate of less than 1 cpm was observed, indicating an alpha activity of less than 0.2 Bq per 100 cm2* activity of approximately 220 Bq L- 1* This activity level Subsequently, the particle sample was prepared for stimulated considerable concern because of the sludge's energy-dispersive x-ray spectrometry (EDX) and scan- use in soil fertility investigations. Subsequent investi-ning electron microscope (SEM) analysis (Lee et al. gations into the initially high 60Co value pointed to the 1991) to determine its composition and size. The cel- presence of a "hot particle," although it was never lophane tape containing the particles was mounted on completely isolated and identified.* a small SEM graphite rod. To date (November 1991), our monitoring pro-After preparing the sample for SEM analysis via gram has processed some 150 samples of anaerobic gold vapor sputtering, the sample was examined for digested sludge, along with some 200 samples of pri-shape, size, and elemental content via EDX and SEM. mary and secondary treatment wastewater samples. No The examination showed that several particles were additional radioactive particles of appreciable activity present. Individual particles were eliminated by cutting have been noted. Apparently, these particles are not the tape on the mount under an optical microscope ubiquitous in the local sanitary wastewater treatment and analyzing each portion for 137Cs. It was found that system, and their occurrences appear to be rate. 137 Cs activity was associated with a single particle, which Because state-licensed facilities are required to pre-was analyzed using SEM. filter radioactive wastewater through 0.45-µm filters before discharging, the isolated particle may have orig-inated after filtration or through a malfunction of a RESULTS AND DISCUSSION filtration system. Although the particle itself is likely The radioactive particle (Fig. 2) was not an aggre- anthropogenic in origin based on its shape, size, and gate but had a cylindrical shape and was approximately activity level, its explicit source remains an enigma. 50 µm in diameter. Its thickness was estimated at about 20 µm based on optical-microscope examination. The lack of any dominant EDX spectrum, other than that attributed to the gold spectra from the sputtering, sug-gested a carbon composition based on the absence of Acknowledgement(s)-This work was supported by the Oak Ridge characteristic metallic x-ray lines. National Laboratory Environmental and Health Protection Division. Al Callahan of the Health and Safety Division assisted with quanti-We were unable to determine the mass of the fication of the particle, and Craig Brandt assisted with the figures. E. particle directly. The mass was estimated at 0.04 µg A. Stetar was supported through the U.S. OOE Operational Health based on a 50-µm diameter, a 20-µm thickness, and an Physics Fellowship Program. Oak Ridge National Laboratory is man-organic density of 1.1 g cc- 1 (i.e., 10% greater than aged by Martin Marietta Energy Systems, Inc., under contract DE-AC05-84OR21400 with the U.S. Department of Energy. Publication water), which corresponds to a 137Cs concentration on No. 3781, Environmental Sciences Division, ORNL. the order of 5 x 10 10 Bq g- 1* During an earlier monitoring period ( 1989), a 3.5- *Personal communications (1991), D. Shults and E. Hanagan, L sludge sample collected from the anaerobic digester State of Tenn~, Bureau of Environment, Department of Health unit of this treatment facility indicated an elevated 60Co and Environment, Nashville, TN.

238 Health Physics March 1992, Volume 62, Number 3 REFERENCES Lee, S. Y.; Hyder, L. K. ; Alley, P. D. Microstructural and mineralogical characterization of selected shales in support Boston, H. L.; Van Miegroet, H .; Larsen, I. L.; Walzer, A. E.; of nuclear waste repository studies. In: Bennet, R. H.; Carlton, J. E. The fate of radionuclides in sewage sludge Bryant, W.R.; Hulbert, M. H ., eds. Microstructure offine-applied to land. In: Environmental contamination, Fourth grained sediments. New York: Springer-Verlag; 1991: 539-International Conference, Barcelona, Spain; October 566. 1990:211-213. Pasternack, B. S.; Harley, N . H . Detection limits for radio-Larsen, I. L.; Cutshall, N. H. Direct determination of Be-7 in nuclides in the analysis of multi-component gamma ray sediments. Earth and Planetary Science Letters 54:379- spectrometer data. Nucl. Instr. Meth. 9 I :533-540; 1971. 384; 1981.

           © Copyright as part of July/August 1993, Vol. 65 :No. 5, Water Environment Research Washington, D.C:. 20037 Printed in U.S.A.

The removal of radioactive cobalt, cesium, and iodine in a conventional municipal wastewater treatment plant Elisabeth A. Stetar, Harry L. Boston, lngvar L. Larsen, Michael H. Mobley

The removal of radioactive cobalt, cesium, and iodine in a conventional municipal wastewater treatment plant Elisabeth A. Stetar, Harry L. Boston, lngvar L. Larsen, Michael H. Mobley ABSTRACT: A radiotracer study was conducted to determine removal 6

                                                                                                    °Co and 150 Bq/kg of mes were measured in the Oak Ridge efficiencies for cobalt, cesium, and iodine in a conventional municipal            sludge in 1984 (Tennessee, 1984 ). These radionuclides were wastewater treatment plant. The study was conducted in a full-scale fa-            believed to have been discharged by a state-licensed facility in-cility that provides primary treatment through physical settling and sec-volved in the decontamination of nuclear power plant compo-ondary treatment using activated sludge. The radiotracers, 58Co and 134Cs nents (Halsey, 1984 ). The quantities of radioactive materials as chlorides, and 131 1 as Na!, were equilibrated in raw wastewater and introduced to the treatment system as a pulse in the incoming raw waste-           that are discharged by state-licensed facilities have been reduced water. Samples of wastewater and sludge were collected and analyzed to             since 1984. However, at present, 6°Co, mes, and 131 1, as well as quantify primary treatment, secondary treatment, and overall removal               depleted uranium are routinely detected in the Oak Ridge treat-efficiencies. Selected samples were filtered to determine the partitioning         ment plant sludge. In 1990, the digested sludge averaged ap-of the tracers between the solid and liquid phases of the wastewater and           proximately 3 Bq/kg of 6°Co, 3 Bq/kg of mes, and 6 Bq/kg of sludge throughout the treatment process. In the incoming wastewater,               131 1, with maximum concentrations of approximately 10, 15, approximately 10% of the 58 Co, 7% of the 134Cs, and 3% of the 1311 were           and 41 Bq/kg, respectively (Boston, 1988-1990).

associated with suspended solj,ds. The suspended tracer fractions decreased For radionuclides to become concentrated in the sludge, they across the treatrilent plant:',Prima:ry treatment* resulted in the partial must be present in forms that are readily removed from the removal of the incoming suspended fraction with observed-removal ef-ficiencies 0(8.l % and 3.0% for cssco artd 134 Cs, ~espe~tiv~ly, a~d an es-wastewater during treatment. Previous studies have shown that timated removal of 2% for 131 1. Approximately 80% of the radiotracers the removal of metals during conventional wastewater treatment in the primary treatment sludge were associated with the sludge solids. results almost exclusively from the physical settling of solids-The affinity of the radiotracer.s f6r the activated ,sludge s~Iids was:in the. *** associated metals (Kempton .et al., 1987, and Stephenson and following order: 58 Co > 134Cs > 131 1. Secondary treatment removal effi- Lester, 1987a). However, the 6°Co, mes, and 131 1 that are dis-ciencies of25% and 9.4% were observed for 58Co and 134Cs, respectively. charged to the Oak Ridge sewer are primarily soluble. Discharges The secondary treatment removal efficiency .forll31 I was estimated to be . of 6°Co and mes from state-licensed facilities are filtered thr~ugh 2-3%. Overall removal efficiencies were 31 %, 12%, and 3-5% for 58Co, 0.45-µm filters prior to release. Iodine-131 enters the Oak Ridge 134 Cs, and 131 1, respectively. The remaining fractions of the radiotracers sewer in the urine of patients who have undergone medical pro-remained within the soluble phase of the wastewater and were discharged

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cedures involving this radionuclide. Therefore, to be removed in the treatment plant effluent. Water Environ. Res., 65, 630 (1993).

from the wastewater during treatment, the 60 eo, 137Cs, and 131 1 KEYWORDS: cesium, cobalt, iodine, partitioning, radionuclides, ra- that are discharged to the sewer must be converted to settleable, diotracer, sludge, wastewater. insoluble forms either during transit through the sewers or within the treatment plant. Like many conventional treatment facilities, the Oak Ridge Municipal wastewaters may contain radionuclides from a va- plant provides primary and secondary treatment of wastewater. riety of sources including industry, hospitals, and atmospheric Primary treatment involves the physical settling of the raw fallout. During treatment some fraction of these radionuclides wastewater, and secondary treatment involves a biological pro-are removed from the wastewater and become concentrated in cess that is followed by physical settling. The removal of metals the treatment plant sludge ( Durham and Joshi, 1979; U.S. EPA, during primary treatment reportedly results from the removal 1986; Imhoff et al., 1988; and Erlandsson et al., 1989). The of those metals that exist within the raw wastewater in settleable, presence of radionuclides in municipal wastewater treatment insoluble forms. Furthermore, the solubility of metals in raw plant sludges is of concern relative to the handling and disposal wastewater is reported to depend primarily on the suspended of these wastes. Current methods of sludge disposal include solids ( SS) concentration-with increases in SS resulting in de-landfilling, incineration, and land application as fertilizer creased metal solubility (Kempton et al., 1987). The SS con-(Mumma et al., 1984, and Boston et al., 1988-1990). centrations in the Oak Ridge wastewater are generally low, rang-In 1984, sludge from the Oak Ridge, Tennessee municipal ing from 100 to 150 mg/L (Tchobanoglous and Burton, 1991 ). wastewater treatment plant was found to contain elevated con- Therefore, somewhat high solubilities and low primary treatment centrations of several radionuclides including 60eo, mes, and removal efficiencies were expected for 6°Co, mes, and 1311 within 131

1. Because the Oak Ridge sludge is used as fertilizer on forest the Oak Ridge treatment plant.

lands, the presence of the longer lived 6°Co and mes (half-lives Secondary treatment within the Oak Ridge plant consists of of 5.27 and 30.2 years, respectively) was of particular concern. a commonly used biological treatment known as activated sludge Concentrations of up to 330 Becquerel (Bq)/kg (wet wt) of (U.S. EPA, 1977). Stephenson and Lester (1987a) found that 630 Water Environment Research, Volume 65, Number 5

Stetar et al. the removal of metals by activated sludge is a twofold process. of primary and secondary treatment relative to the removal of They observed that metals removal included the removal of both these radionuclides, a radiotracer study utilizing 58Co, 134Cs, and 131 insoluble metals ( that is, those hot removed during primary 1 was conducted. During the tracer study, data were gathered treatment) and soluble metals that were converted into insoluble to ( 1) determine the partitioning of the radiotracers between forms by the activated sludge process. However, they concluded the solid and liquid phases throughout the treatment process, that the removal of the soluble fraction was not significant for and (2) determine the resulting sludge and liquid eflluent ra-a number of metals, including cobalt. diotracer concentrations. In contrast to the findings of Stephenson and Lester, the re-moval of soluble 6°Co by the activated sludge process was hy- Methods pothesized to be the major removal mechanism for this radio- The Oak Ridge Wastewater Treatment Plant. The Oak Ridge nuclide within the Oak Ridge wastewater treatment plant. Com- Municipal Wastewater Treatment Plant is a conventional treat-parisons of the quantities of 6°Co reportedly discharged to the ment facility designed to receive both domestic raw wastewater sewer with the quantities measured in the sludge suggested that and industrial wastewaters. The plant services greater than 12 000 the overall removal efficiency for this radionuclide in the Oak households and 40 industries. On average, 19-23 ML of raw Ridge plant was high, almost 100%. Because the primary treat- wastewater enter the Oak Ridge treatment plant each day. ment removal efficiencies were expected to be low, it appeared Sources of radionuclides in this system include discharges by that significant removal of soluble 6°Co must occur during the facilities involved in the processing of radioactive waste, the pro-secondary treatment process. duction and processing of depleted-uranium metal, and the nu-High secondary treatment removals were also expected for clear medicine department of a local hospital. mes. Because cesium has a high affinity for SS (Onishi et al., Wastewater from throughout the Oak Ridge area flows into 1981), much of the soluble mes was expected to become as- a wet well located within the main raw wastewater pumping -sociated with the secondary treatment solids ( av solids concen- station and is pumped from the wet well to the head *of the tration = 1 800 mg/L) and be removed from the wastewater treatment plant (Figure 1). Within the plant, the wastewater during final settling. In contrast to 6°Co and 137Cs, 1311 has a low flows through a screening and grit removal system into two pri-affinity for suspended particulates ( Onishi et al., 1981 ) and was, mary settling tanks where the settleable solids are removed. On therefore, expected to have a low secondary treatment removal average, the Oak Ridge plant removes approximately 60% of efficiency. the incoming SS. This removed fraction represents approxi-To quantify the overall removal efficiencies for 60Co, mes, mately 98% of the incoming settleable solids. The settled solids and 1311 in the Oak Ridge plant, and to determine the importance form the primary, or raw, sludge which is continuously raked Bar Screens t - - - - - - - - - - ; ~ Primary Settling Tanks Plant Influent and Grit Removal Primary Treatment Landfill Effluent Secondary Primary Anaerobic Anaerobic Digester Digester Aeration Tanks Thickened Return Activated Sludge Sludge Mixed Liquor Land Sludge Application Storage Waste Tank Activated Final Settling Tank Sludge Final Effluent to Creek Cascade Post Final Filters Secondary

     "'--------------~ Aeration                            ----'------1            and                                      Clarifier Chlorination                                   Effluent Figure 1-0ak Ridge Wastewater Treatment Plant flow diagram and sampling-locations.

July/August 631

Stetar et al. from the bottom of the settling tanks into two large hoppers. Meriden, Conn.) Model 6700 or Model 9900 microprocessor Approximately 42 kL of raw sludge at 3-4% solids are pumped systems programmed to record gamma spectra in 4 096 channels. from these hoppers into the sludge digesters each day ( 14 kL Efficiency calibrations for the systems were determined for the each 8-hour shift). various counting geometries using National Institute of Standards Following primary treatment, the settled wastewater flows into and Technology traceable standards ( Larsen and Cutshall, 1981 ) . a series of aeration chambers where it is mixed with return ( re- Radiotracer concentrations were reported for the time of sample cycled) activated sludge creating a ll"!ixed liquor ofapproximately collection. The total tracer activities observed in sludge and 1 800 mg/L SS. As the mixed liquor flows through the aeration wastewater were decay corrected to the time of tracer introduc-chambers it undergoes aerobic digestion. The digested wastewater tion for the purpose of determining removal efficiencies. flows into two secondary clarifiers (settling tanks) where the mixed liquor solids are allowed to settle. The clarified wastewater Sampling and Data Analysis is then filtered, chlorinated, and discharged into a small stream. Wastewater samples. Wastewater sampling was designed to The settled solids form the secondary sludge, which is contin- track the radiotracer pulse through the plant and to evaluate the uously recycled to the head of the aeration chambers as return partitioning of the radiotracers between the suspended and dis-activated sludge. Because biological solids are constantly pro- solved fractions of the wastewater at each stage of treatment. duced within the aeration chambers, sludge must be routinely One-litre grab samples of the treatment plant influent (Point 1, removed from this system. Approximately 10% of the activated Figure 1), the primary treatment effluent (Point 2), and the sludge ( 150 kL at 1.1 % solids )is removed, thickened, and trans- secondary treatment effluent (secondary clarifier effluent) (Point ferred to the sludge digesters each day. The thickening process 3) were collected following introduction of the radiotracers. involves the addition ofa polymer and dewatering of the sludge Sampling intervals were chosen based on the expected width of to 4-6% solids in a dissolved air floatation thickener. the pulse (that is, the degree of mixing) at each of the sampling The sludges produced during primary and secondary treat- locations. The initiation and duration of the sampling periods ment are pumped into two primary anaerobic digesters for sta- were chosen based on the estimated retention time for wastewater bilization and volume reduction. The primary digester sludge within each stage of treatment. then enters a secondary anaerobic digester for final treatment. Radiotracer partitioning between the suspended and dissolved The digesters are designed to provide an average retention time fractions was determined for two influent samples, one primary of approximately 60 days. Following anaerobic digestion the treatment effluent sample, and one secondary clarifier effluent sludge is hauled to the Department of Energy's Oak Ridge Res- sample. Samples containing sufficient total activity to make de-ervation for land application as a soil conditioner. Almost 17 tectable activities in both the suspended and dissolved fractions ML of digested sludge are generated by the Oak Ridge plant likely were selected for partitioning. annually. Flow proportional composite samples of the treatment plant influent and effluent were also collected during the radiotracer Radiotracer Introduction study. A flow proportional composite influent sample (Point 1) A solution containing three radiotracers, 58Co, 134Cs, and 131 1 was collected over a 3-hour period that began just before the (half-lives of71.3 days, 2.05 years, and 8.05 days, respectively), release of the tracers. The influent sampler was set to collect an was introduced to the Oak Ridge treatment plant as a pulse aliquot from every 4 kL of influent. Flow proportional composite added to the incoming wastewater via the pumping station wet samples of the treatment plant effluent (Point 4) were collected well. Prior to their introduction, the radiotracers ( 58Co and 134Cs for 4 days following introduction of the tracers. The effluent as chlorides, and 131 1 as Nal) were mixed with 19 L ofraw waste- sampler was set to collect an aliquot from every 40 kL of treat-water and allowed to equilibrate for 4 hours. The equilibration ment plant effluent. The effluent sample concentrations and the period was designed to allow representative partitioning of the effluent volumes were used to determine the tracer quantities cobalt, cesium, and iodine between the solid and liquid phases discharged in the treatment plant effluent. of the wastewater. The 4-hour period was chosen because it ap- Sludge samples. Samples of the raw (primary) and thickened proximated the average transit time for radionuclides discharged (secondary) sludges were collected and analyzed to provide data into the Oak Ridge sewer. A sample of the tracer solution was needed to determine the primary and secondary treatment re-collected and analyzed to quantify the tracer activities intro- moval efficiencies. The tracer quantities present in the sludges duced. ( that is, the fractions removed from the wastewater) were cal-The nominal elemental concentrations of the tracers were not culated based on the tracer concentrations and the total volumes expected to influence partitioning significantly (Kempton et al., of sludge produced. The overall removal efficiencies for the Oak 1987, and Wang et al., 1975). The 58Co and 131 1 tracers were Ridge plant were calculated based on the combined primary carrier free, and the 134Cs tracer contained less than 0.2 mg of and secondary treatment removals. For comparison, the overall stable cesium. Furthermore, no significant differences were ex- removals were also determined using the tracer quantities mea-pected between the physicochemical behaviors of 58Co and 6°Co sured in the final, digested sludge. or 134Cs and 137Cs either during equilibration or within the treat- Samples of the raw and thickened sludges were collected ment process (Wang et al., 1975). throughout the first week following tracer introduction. These sample data were used to calculate the tracer quantities present Analytical Techniques in the sludges during the first week. Models based on these sample All of the radiotracer study samples were analyzed by gamma data were used to predict the concentrations and quantities pres-spectrometry using low background, high resolution Ge(Li) or ent after the first week. Ge(IG) solid-state detectors (Tennelec/Nucleus, Oak Ridge, The raw sludge samples were collected from a transfer line Tenn.) equipped with either Nuclear Data ( Canberra Nuclear, between the collection hoppers and the primary digesters (Point 632 Water Environment Research, Volume 65, Number 5

Stetar et al. 5, Figure 1). Approximately 12 kL of raw sludge were pumped The tracer activities associated with the liquid phase of selected three times per day at an average rate of200 L/m. During each sludge samples were determined by centrifuging the sludge and pumping, grab samples were collected at 10-minute intervals filtering the supernatant as above. Prior to centrifuging, the total ( that is, approximately every 2 kL). The grab samples taken tracer activities were determined, and aliquots of the sludge were during the first two pumpings following tracer addition were dried and weighed to determine the solids content. The fractions collected directly into 1-L Marinelli beakers for analysis. These of the tracers associated with the sludge solids were calculated samples were analyzed separately to ensure the sampling fre- based on the difference in the total tracer activities and the ac-quencies were adequate based on the variabilities observed in tivities observed in the liquid phase. the tracer concentrations. One grab sample from each of these first two pumpings was duplicated to provide an estimate of the Sample Preservation sampling error. Two of the grab samples from the second pump- To preclude the loss of the radiotracers through plateout on ing were centrifuged and filtered to evaluate radiotracer parti- the walls of collection containers, most samples were collected tioning. As the study progressed, the 10-minute grab samples directly into 1-L Marinelli counting beakers. Large volume, flow-were collected into a large polyethylene container from which proportional influent and effluent samples were collected in 20-1-L composite samples were removed for analysis. L polyethylene containers and acidified with nitric acid to pH The thickened sludge samples were collected at the point where < 2 to minimize tracer plateout. One-litre aliquots of these sam-the sludge is removed from the dissolved air floatation thickener ples were transferred from the collection containers into Marinelli for transfer to the primary digesters (Point 6). Hourly samples beakers for counting. When tracer activities in these aliquots were collected during thickener operation, and for the first 2 were too low for adequate detection, the samples were evapo-days, these samples were composited over 3-hour periods. On rated, and the remaining concentrates were analyzed. The sam-the third day of thickener operation, daily compositing was ini- ples were slowly evaporated over low heatto minimize potential tiated. Two of the 3-hour composite samples were centrifuged losses of 1311 through volatilization. To minimize potential losses and filtered to evaluate radiotracer partitioning. One of the daily due to plateout, the evaporating dishes were rinsed with an acidic composite samples was duplicated to provide an estimate of the solution, and the rinse was added to the concentrated sample sampling error. for analysis. All tracer study samples were refrigerated during Activated sludge samples were also collected throughout the storage both prior to and following analysis. study (Point 7). Two of these samples were centrifuged and Samples used for partitioning determinations were filtered as filtered to evaluate radiotracer partitioning in the secondary soon after collection as possible, usually within 5 hours for treatment sludge prior to the addition of polymer during the wastewater samples and within 24 hours for sludge samples. The thickening process. samples were not acidified but were refrigerated immediately As part of an ongoing monitoring program, samples of th~ following collection to minimize potential changes in the sus-digested sludge are routinely collected each time the Sludge is pended and dissolved fractions prior to filtration. pumped from the secondary digester for transport to the land application sites ( Point 8). These samples are composited on a Results weekly basis for gamma spectroscopy analysis (Boston, 1988- Radiotracer quantities. Based on analysis of the tracer solution 1990). The radiotracer quantities observed in these routine sample, the total tracer quantities introduced were 45.9 +/- 0.370 sludge samples were calculated and compared to the quantities MBq of 58 Co, 33.2 +/- 0.185 MBq of 134Cs, and 65.9 +/- 0.740 estimated to have been removed by both primary and secondary MBq of 131 1. The reported errors are the one standard deviation treatment during the radiotracer study. A model was used to counting errors. predict the tracer quantities after their concentrations dropped The tracer quantities introduced were also calculated based below detectable levels in the digested sludge. on the concentrations measured in the flow proportional com-Prior to introduction of the radiotracers, grab samples of the posite sample of the treatment plant influent. These values were raw, activated, and thickened sludge were collected to identify within 5% of the quantities determined based on the tracer so-potential background levels of 58 Co, 134Cs, or 131 I. lution sample. The radiotracer quantities determined using the tracer solution sample data were used in the removal efficiency Activity Balances calculations that follow. Activity balances were calculated for each of the radiotracers Wastewater data. The grab samples of the treatment plant by summing the tracer quantities observed in the sludge and influent were analyzed and the radiotracer concentrations were treatment plant effluent and dividing these sums by the initial plotted as a function of the time after tracer introduction (Figure tracer quantities introduced to the system. 2). The total tracer quantities in the influent were also estimated using the concentrations observed in these samples and the in-Partitioning fluent volumes represented by each sample. The quantities ob-The tracer activities associated with the dissolved and sus- tained were 48 MBq of 58 Co, 33 MBq of 134Cs, and 67 MBq of 131 pended fractions of the wastewater were determined for selected 1. The tracer quantities estimated using the grab sample data samples with high total activities as follows: The samples were were within 5% of the tracer quantities calculated using the tracer thoroughly agitated to ensure homogeneity, and 500 mL aliquots solution sample data. were removed and vacuum filtered using Whatman GF /C glass The primary treatment effluent grab samples were analyzed fiber prefilters (particle retention approximately 1.2 µm) and and the tracer concentrations were plotted as a function of the 0.4-µm membrane filters. The filters and 200 mL aliquots of the time after tracer addition ( Figure 3). These curves were extrap-final filtrate were analyzed. The filters were then dried and olated to. predict concentrations in the primary effluent after weighed for determination of the SS concentration. sampling had been discontinued (at t approximately 300 min-July/August 633

Stetar et al. 1200*+-----......,;...;.._....._.;;................- .......__..___.__....._-,.;- 8

                                                                         .sseo                     7                                                           sseo 1000 0134Cs                                                                                 Q134Cs 6

b, 1311 ....

" A 1311 C"' 5 eC

                                                                                           .2       4 1a 3                                                                              /

iC: 2 8 1 0

      -200-1-........~-.-~...-.......,.----.-~...--,.----.--""T"""--+

7.5 10 12.5 15 17.5_ 20 22.5 25 27.5 30 32.S -1 0 2 4 6 8 10 12 14 16 18 Time after tracer introduction (min) Time after tracer introduction (h) Figure 2-Radiotracer concentrations in the treatment Figure 4-Radiotracer concentrations in the secondary plant influent as a function of the time after tracer intro- treatment ( secondary clarifier) effluent as a function of A duction. Error bars *represent the 1 standard deviation the time after tracer introduction. Error. bars represent W counting errors. In some cases, the error bars are smaller the 1 standard deviation counting errors. than the data points and, therefore, cannot be seen. However, based on the tracer concentrations ,observed and the utes} The total tracer quantities remaining in the wastewater clarifier effluent volumes represented by each 'sample, 28% of after'primary treatment were calculated using the concentrations the 58Co, 36% of 134Cs, and 55% of the 131 1 that were introduced measured in the grab samples and'the volumes of primary treat- to the treatment system were discharged from secondary treat-ment effluent represented by each sample. Based on these quan- ment within 17 hours. tities, at least 81 % of the initial 58Co tracer quantity, and 91 % The fractions of the tracer activities associated with SS were of the initial 134Cs and 131 1 tracer quantities were still present in determined for the 17-minute and 18-minute influent samples, the wastewater following primary treatment. the 178-minute primary effluent sample, and the 6.8-hour sec-The secondary freatment(~econdary clarifier) efflue_nt grab ondary clarifier.effluent sample (Table I). samples were analyzed and the tracer concentrations were plotted The flow-proportional effluent samples were analyzed to de-as a function of the time after tracer addition ( Figure 4). It termine the average tracer concentrations and the total tracer appears that a significant portion of the radiotracers were still quantities_ discharged in the treatment plant effluent (Table 2). present within secondary treatment at the time sample collettion Approximately 48% ofthe'initial 58Co tracer quantity, 85% of was discontinued. Because' the -radiotracer pulses were poorly the initial 134Cs tracer quantity, and 95% of the initial 131 1 tracer defined in secondary clarifier effluent, the curves* could not be q~antity were detected in the treatment plant effluent. Dupli- A extrapolated to permit estimation of the tofal'-fracer quantities cation of the flow proportional sampling was not possible;*there- W that remained in the wastewater following secondary treat~~nt. fore, the sampling error associated with these values is not known. 60 *1 ~ :-- ** Sludge Data-Removal* Efficiencies *'

• so

                                                                     , ,  ;58Co                Background '"sampling and the presence of 131 1. No 58Co or 0134Cs             134 Cs was detected in the background samples collected the day
.... 40                                                               .6.131 I           before the radiotracer study commenced. However, 131 1 was de-C""

e 30 C: Table 1-Partitioning of the radiotracers in the was~e-

 ~                                                                                          water.

ti* 20'

• C: .*
• 1 1f C:

Tracer activity 10 associated with 8 suspended solids", 0 .. Time after Total  % tracer suspended 08 134 1311

       .101+-.--.~-.--..................~....-~.----r-~~...--,.---,.-+                         Sample type              addition      solids, mg/L        co          Cs 0      so 100 150 200 250 "300 .*:.                       350_ 400 450 500 Influent                   17 minutes         105:0         10.2        6.6     4.3
                      * ,, . Time after tracer introduction *(min)                          Influent                   18 minutes          91.2         ho          7.0   . 2.4 Primary effluent          178 minutes          43.6           4.9       5.3     1.8 Figure"' a...:..::Radiotracer conceritrations,' in the' primary Secondary clarifier treatment effluent as a function of the"tirne 'after tracer                                   effluent                  6.8 hours         17.3,,         2.0       2.6     0.4 intrt>ductio_n. Error bars represent th~ 1 standard deviation counting errors.                                           .

• Based on filtration of grab samples using O.45-µm merilbrane filters.

634 Water Environment Research, Volume 65, Number 5

• Stetar et al.

Table 2-Radiotracers in the treatment plant effluent flow- used to predict concentrations for times beyond the range of proportional composite samples. measured data, no confidence intervals or other statistical in-ferences were applied to the predicted values. The data for sam-Radiotracer ples collected before the peak concentrations were reached .in concentrations in flow-proportional Treatment Total tracer the raw sludge were not used in the regressions. Based on the Time after composite samples*, plant activities measured and estimated radiotracer concentrations and the total tracer Bq/L effluent detected", MBq volumes of sludge produced, the primary treatment removal introduction, 134 131 volumes, 134 efficiencies were 8.1 % for 58Co and 3.0% for 134Cs. Approximately 58 hours Co0 Cs* 1° ML 58 Co Cs 131 1 70% of the 58Co and 90% of the 134Cs that were calculated to 0.63 2.3 16 10 37 have been removed during primary treatment were based on 0-16 0.48 7.8 16-40 0.56. 0.63 1.5 17 9.5 11 26 measured sample concentrations. The remainders were based 40-64 0.20 0.26 N.D.' 18 3.6 4.7 N.D. on model estimates. 64-88 0.067 0.12 N.D. 20 1.3 2.4 N.D. Two samples were centrifuged and filtered to evaluate the Total period 22.2 28.1 63 partitioning of the radiotracers within the raw sludge and to determine the raw sludge solids content. The sludge was ap-

• Concentration at time of collection. proximately 3% solids, and approximately 80% of the 58Co, 134Cs,

      °Calculated by multiplying the tracer concentrations by the effluent volumes and       and 131 1 activities were associated with the sludge solids.

decay correcting to the time of tracer introduction. c One standard deviation counting errors ranged from 8-20%, average = 12%. The 11-hour and 11.75-hour raw sludge samples were dupli-

• One standard deviation counting errors ranged from 3-10%, average = 8%. cated. The concentrations observed in the duplicate samples were
• One standard deviation counting errors were 7.8% and 8.0%, respectively. within 10% of the concentrations observed in the initial samples.

      ' Not detected.                                                                        The one standard deviation counting errors associated with the raw sludge data ranged from 4-20% with a mean of 10%.

Secondary treatment. The tracer quantities removed during tected in the raw, activated, and thickened sludge samples at secondary treatment were calculated using measured and pre-concentrations ranging from 2.3 to 4.2 Bq/kg (wet wt). dicted tracer concentrations and the volumes of sludge trans-Nuclear medicine procedures at the local hospital resulted in ferred from the thickener to the primary digesters. The predicted a significant quantity of 131 1 being. released to the Oak Ridge concentrations were based on exponential regressions of the sewer several days after tracer introduction. The presence of this measured tracer concentrations as a function of time (Figure 131 1 precluded the use of the sludge data in determining removal 6). No sludge was removed from secondary treatment for thick-efficiencies for the 131 I tracer. ening and transfer until approximately 19 hours after tracer in-Primary treatment. The tracer quantities present in the raw troduction. Because the tracers had become well mixed within sludge (that is, removed during primary treatment) were esti- the continuously recycling sludge at the time thickened sludge mated as a function of time using measured and predicted tracer sampling began, the peak concentrations were observed in sam-concentrations and the volumes of raw sludge pumped to the ples collected during the first day of thickener operation. Based primary digesters. The predicted concentrations were based on on the measured and predicted concentrations, secondary treat-exponential regressions of the measured sample concentrations ment removed 25% of the 58Co and 9.4% of the 134Cs that re-as a function of time ( Figure 5 ) . Because these regressions were mained in the wastewater following primary treatment. The 12 35

                                                                  -a-51!eo
                                                                                               .., 30                p                             --...:.a-- 511 co
   ~        10                                                                                  a:

I 8

                                                                  -e-134cs                    I        25
                                                                                                              ~
                                                                                                                                                   - e -134cs "i'bO
  ~

(I) 1P 20 I, C' e C' 6 ec::

 .g g

c:: 4 fT3/4~1t ---( D- ---

                                                                                              .9
                                                                                              'iii 1:l 8c::

15 10 cp ~---

                                                                                                                        .'-t ......
 ]            2                                      (lr-_

(D-- m 8 5 . cl)-- -

                                                                                                                                                - -e _. -(I) 0                                                                                         0 0                50                  100

• 150 200 0 50. 100 150 _ 200 Time after tracer introduction (h) Time after .tracer in,troduction (h)

Figure 5-Exponential regressions of the tracer concen- Figure 6-Exponential regressions of the tracer concen-trations in the raw sludge ( primary treatment sludge) as trations in the thickened sludge ('secondary treatment a function of the time after tracer iri'troduction. Error sludge) as a function oUhe1time after tracer introduction. bars represent the 1 standard deviation counting errors. Error bars*represent the 1 standard deviation counting For 58 Co, Y = 12.1 e<-o.ooso9 x>; r = 0.970, and foJ. 134Cs, errors. For 58Co; Y = 34.9 e 1- 0 *00511 x, 1; r = 0.876, and for Y = 6.02 e1-o.o,o,x1; r = 0.927.

• 13'1Cs, y = 22.3 e<-D:0132XI; r = 0.943.,
• July/August *535

Stetar et al. 2.5 concentrations after they dropped below detectable levels (Figure 7). Based on the measured and predicted concentrations and

,.....                                             ---B-~Co        the volumes of sludge removed from the secondary digester, the i        2                                                        overall removal efficiencies were estimated to be 31 % for 58eo j                                                - e -134cs      and 11 % for 134es.

~a' 1.5 Approximately 90% of the 58 eo and 80% of the 134es that were calculated to have been present in the digested sludge were e based on measured sample concentrations. c:l

 .53      1 p                                          No duplicate samples of the digested sludge were available
 ;                 f     qi                                        for use in estimating the potential sampling error associated with
  §                                                                these data. The counting errors ranged from 8-60% with a mean 0.5 8                  1ii\i)t                                       of22%. These large errors were the result of the low tracer con-centrations present in the digested sludge.

0 Activity Balances 0 so 100 150 200 250 The activity balances were calculated for each of the radio-Time after tracer introduction (d) tracers based on the quantities added, the quantities observed Figure 7-Exponential regressions of the tracer concen- in the sludge, and the quantities observed in the treatment plant trations in the digested sludge (final sludge) as a function eflluent ( Table 3). of the time after tracer introduction. Error bars repre-sent the 1 standard deviation counting errors. For 58 Co, Discussion 60 Y = 3.19 e 1- 0 *0195 X>; r = 0.956, and for 134Cs, Y = 0.692 Primary treatment. The eo and mes that enter the Oak e 1-0.0°915 x>; r = 0.817. Ridge plant are generally below detectable concentrations. Therefore, the extent to which they become partitioned to SS quantities removed during secondary treatment represent 23% during transit through the sewers is not known. Suspended frac-of the initial 58eo tracer quantity, and 9.0% of the initial 134es tions for stable cobalt in raw wastewater have been observed to tracer quantity. Approximately 70% of the 58eo and 90% of the range from 29% to 45% at SS concentrations from 475 to 760 134 es that were calculated to have been removed during second- mg ( Kempton et al., 1987). Before their introduction, the ra-ary treatment were based on measured concentrations in the diotracers were equilibrated to ensure that their partitioning thickened sludge. within the treatment plant influent would be representative of Two of the thickened sludge samples were centrifuged and the partitioning of the 60 eo, mes, and 131 1 normally present in filtered to evaluate the partitioning of the radiotracers in the the Oak Ridge system. Based on the influent grab samples, only thickened sludge and to determine the thickened sludge solids 10% of the 58eo tracer was associated with the influent SS. This content. To evaluate partitioning in the secondary treatment smaller suspended fraction was not unexpected considering the sludge prior to thickening, two activated sludge samples were relatively low SS concentration of 100 mg/L observed in the also centrifuged and filtered. The activated sludge was approx- influent samples. The average suspended fraction observed for . imately I% solids, and the thickened sludge was approximately the 131 1 tracer was 3%. Suspended 131 1 fractions of 2% and 9%

• 4% solids. Approximately 80% of the 58eo, 78% of the 134es, and 50% of the 131 1 were associated with the activated sludge Table 3-Activity balances based on the overall removal solids. In the thickened sludge, approximately 95% of the 58eo efficiencies and the fractions of the tracers detected in and 80% of the 134es and 131 1 were associated with the sludge the treatment plant effluent.

solids. Fraction of The 70-hour thickened sludge sample was duplicated. The Removal efficiencies initial tracer duplicate sample tracer concentrations were within 5% of the activity concentrations observed in the initial sample. The one standard Primary Secondary detected in Activity deviation counting errors associated with the thickened sludge treatment", treatment*, Overall 0 , the effluent, balance*, data ranged from 5-20% with a mean of 8%. Radiotracer  %  %  %  %  % Overall removal efficiencies. Based on the combined primary 8.1 25 31 48 79 and secondary treatment removals, the overall removal efficien- 3.0 9.4 12 85 97 cies were 31 % for 58eo and 12% for 134es. 95 95° For comparison, the overall removals were also estimated based on the tracer quantities measured in the final, digested

• Fractions of the initial tracer quantities that were removed during primary treatment sludge, which is sampled routinely as part of an ongoing mon- (that is. detected in the primary treatment, or raw sludge).
• Fractions of the tracers present in the wastewater following primary treatment itoring program. The tracers were detected in the digested sludge that were removed during secondary treatment (that is, detected in the secondary for almost 7 months following tracer introduction. This long treatment or thickened sludge).

retention time resulted in the tracers being mixed within greater 0 Based on the combined primary and secondary treatment -removals (not the than 9.8 ML of the digested sludge; therefore, the tracer con- sum of the primary and secondary treatment removal efficiencies).

• Fraction of initial tracer activities that were detected in the sludge and effluent centrations were low. The maximum concentrations observed (sum of the overall removal efficiency and the fraction of the initial tracer activity were approximately 1.9 Bq/kg (wet wt) of 58eo and 0.74 Bq/ detected in the plant effluent).

kg of 134es. An exponential regression of the measured concen-

• Sludge data could not be used to quantify the 131 1 removal efficiencies. Activity trations as a function of time was used to predict the tracer balance for 131 1based on effluent data only.

636 Water Environment Research, Volume 65, Number 5

Stetar et al. have been observed previously in Oak Ridge influent samples moval for 134Cs of 12%, the soluble fraction removed during collected during two releases from the local hospital (preliminary secondary treatment could account for more than half of the investigations conducted in conjunction with this radiotracer total 134Cs removed during primary and secondary treatment. study). The observed removals for soluble 58Co and 134Cs during sec~ During primary treatment approximately 60% of the incoming ondary treatment were much lower than anticipated. Based on SS were removed. Therefore, removal of approximately 60% of the particle reactive nature of cobalt and cesium and the high the r_adiotracers associated with the influent SS was expected at SS concentrations present in the mixed liquor, substantial frac-this stage of treatment. Based on the suspended tracer fractions tions of these tracers were expected to partition to the secondary (Table 1), the expected removals were 7% for 58Co, 4% for 134Cs, treatment solids and be removed from the wastewater during and 2% for 131 1. The observed primary treatment removal effi- final settling. The reasons for the low secondary treatment re-ciencies for 58Co and 134Cs were 8.1 % and 3.0%, respectively. movals are not known. However, previous studies suggest that The 131 1 removal efficiency could not be determined. The close soluble metals are not effectively partitioned to the secondary agreement between the expected and observed removals for 58Co treatment solids because they become complexed_by soluble or-and 134Cs indicates that only those radionuclides associated with ganic ligands present in the raw wastewater (Stoveland and Les-the incoming SS were removed to any significant degree during ter, 1980, and Nielsen et al., 1987). primary treatment. Interestingly, the rates at which 58Co, 134Cs, and 131 1 moved A primary treatment removal efficiency of 20% was reported through the secondary treatment process appeared to differ. Al-for stable cobalt by Kempton et al. ( 1987). This somewhat higher most 100% of the 131 1 that was discharged in the treatment plant removal efficiency can be attributed to the relatively large sus- effluent passed through the plant within the first 48 hours (Table pended fraction of 29-45% in that study. 2). However, only 54% and 72% of the total quantities of 58Co The tracer quantities observed in the primary treatment ef- and 134Cs that are believed to have been discharged in the effluent fluent were lower than expected based on the calculated primary passed out of the plant during this same period (Table 2). These treatment removal efficiencies (primary sludge sample data). data indicate that portions of the 58Co and 134Cs that were even-The primary treatment effluent sampling frequencies may have tually discharged with the wastewater initially became associated been inadequate to define the actual peak radiotracer concen- with the mixed liquor solids and were, therefore, recycled within trations ( that is, the pulse front may have been sharper than secondary treatment. indicated in Figure 3). Using the primary treatment effluent Overall removal efficiencies for 58 Co and 134Cs. Good agree-sample data, primary treatment removal efficiencies of 19%, ment was obtained between the overall removal efficiencies cal-9.6%, and 9.0% would be estimated for 58Co, 134Cs, and 131 !, culated for 58Co and 134Cs based on the combined primary and respectively. Although these values are believed to be inflated secondary removals and those calculated based on the tracer because of inadequate sampling frequencies, they do provide an quantities observed in the digested sludge. upper bound for the removal efficiency estimates calculated using Because the 58Co and 134Cs tracers were recycled within sec-the raw sludge data. ondary treatment, they became mixed within large volumes of Secondary treatment. As hypothesized, the major removal wastewater. Therefore, their concentrations in the treatment mechanism for cobalt in the Oak Ridge plant was the removal plant effluent were low and difficult to detect. Based on the es-of the soluble fraction during the activated sludge process. How- timated overall removal efficiencies, 69% of the 58Co and 88% ever, the actual removal efficiency for soluble 58Co was lower of the 134Cs tracer quantities should have been observed in the than anticipated. Five percent of the 58Co in the primary treat- treatment plant effluent. Forty-nine percent of the 58 Co and 85% ment effluent (secondary treatment influent) was associated with of the 134Cs were accounted for in the composite samples before SS. Stephenson and Lester ( 1987a) reported activated sludge the tracers dropped below detectable levels in the treatment plant removals for insoluble cobalt of 40-75%. Assuming a similar effluent. removal for the insoluble 58Co fraction, the removal efficiency The overall 58Co removal efficiency of 31 % was substantially for soluble 58Co was estimated to be approximately 23%. This lower than the removal efficiencies of 80-100% initially estimated value is within the range of soluble cobalt removal efficiencies for 60Co in the Oak Ridge treatment plant. These initial estimates reported by Stephenson and Lester ( 1987a). The removal of were based on comparisons of the quantities of 6°Co reportedly soluble 58 Co by the activated sludge process accounted for almost discharged to the sewer with the quantities measured in the di-70% of the overall 58Co removal observed in the Oak Ridge gested sludge. Published data suggest that cobalt is relatively treatment plant. soluble in raw wastewater and the removal of soluble cobalt A total secondary treatment removal efficiency of 25% was during both primary and secondary treatment is low (Kempton observed for the 58Co tracer. Substantially higher removals of et al., 1987; Stephenson and Lester, l 987a,b; and Sterritt and cobalt, ranging from 35% to 60%, were reported by Stephenson Lester, 1981 ) . These findings and the low removals observed an,d Lester ( 1987a). However, these higher removals resulted for 58 Co suggest that the data for 6°Co input to the Oak Ridge primarily from the removal of the insoluble fraction. Secondary treatment plant are underestimated. treatment removal efficiencies of less than 10% have been ob- The 12% removal efficiency observed for the 134Cs tracer in served for stable cobalt in laboratory simulations of activated the Oak Ridge plant is substantially lower than the removal sludge treatment ( Sterritt and Lester, 1981, and Kempton et al., efficiencies of 37% and 56% reported for 134Cs and 137Cs in a 1983). wastewater treatment plant in Lund, Sweden (Erlandsson et al., The total secondary treatment removal efficiency for 134Cs 1989). These radionuclides were deposited on the ground fol-was only 9.4%. Therefore, only a small fraction of the soluble lowing the Chernobyl nuclear power plant accident and were 134 Cs in the primary treatment effluent was removed by the ac- carried into the sewer system via surface runoff. Much of this tivated sludge process. However, based on the low overall re- fallout cesium may have entered the treatment plant in insoluble July/August 637

Stetar et al. forms ( for example, absorbed to clay soil particles) which would The full-scale study conducted here provides a more accurate account for the relatively high removal efficiencies observed. representation of radionuclide behavior in the Oak Ridge treat-The overall removal observed for the 134Cs tracer was similar to ment plant than could be obtained via laboratory simulations. the 7% removal previously estimated for mes in the Oak Ridge However, the potential exists that the suspended and dissolved treatment plant ( Halsey, 1986). This previous estimate was based fractions of the radiotracers differed somewhat from those of on reported discharges and the quantities observed in the digested the radionuclides that are routinely present in the Oak Ridge sludge. wastewater. Furthermore, it is recognized that removal efficien-131 1 removal efficiencies. Additional releases of 131 1 to the Oak cies can be influenced by several factors. In primary treatment Ridge sewer from other sources during the tracer study precluded the removal of metals generally increases with increasing solids the use of the sludge data in determining removal efficiencies and decreases with increasing hydraulic loadings ( Kempton et for this radionuclide. Using the quantities observed in the pri- al., 1987, and Rossin et al., 1983). In the activated sludge process, mary treatment eflluent, the primary treatment removal effi- factors influencing metals removals include sludge age, solids ciency for 131 1 would be estimated at approximately 9%. How- concentrations, and chemical oxygen demand (COD) (Ste-ever, as discussed above, this estimate is believed to be high. phenson and Lester, 1987a; Sterritt and Lester, 1981; Kempton Because only 3% of the 1311 tracer was associated with the influent et al., 1983; and Rossin et al., 1982). In addition, an increase SS, the actual primary treatment removal efficiency is expected in the incoming metals concentrations has been observed to to be closer to 2%. decrease the removal of some metals during the activated sludge Approximately 63 MBq of 131 I was observed in the treatment process (Petrasek and Kugleman, 1983). plant eflluent samples. The initial tracer quantity was approxi- Because the Oak Ridge plant is a conventional treatment fa-mately 66 MBq, therefore, the overall removal efficiency for 1311 cility serving a typical municipality, the results from this study in the Oak Ridge plant is believed to be on the order of 3-5%. are expected to be applicable to other municipal wastewater Based on the estimated 2% removal ( 1.3 MBq) during primary treatment systems that employ the activated sludge process. treatment, no more than 1.7 MBq or 2.5% of the 131 1 that entered However, potential differences in plant operating parameters as secondary treatment was removed during the activated sludge well as the nature of the incoming wastewater must be considered process. The low secondary treatment removal is attributed to if the Oak Ridge data are to be applied to other systems. the low affinity of 131 1 for the activated sludge solids. Only 50% of the 131 1 activity in the activated sludge was associated with Conclusions the sludge solids. Almost 80% of the 58Co and 134Cs activities in The suspended radiotracer fractions decreased across the this sludge were associated with the solid phase. treatment plant. In the treatment plant influent, approximately The presence of 131 I in-municipal wastewater treatment plants 11% of the 58Co, 7% of the 134Cs, and 3% of the 131 1 were asso-is widely reported (Sodd et al., 1975; Erlandsson and Mattsson, ciated with suspended solids. In the secondary clarifier eflluent, 1977; Durham and Joshi, 1979; Prichard et al., 1981; Ault, 1989; the suspended fractions were 2%, 3%, and 0.4%, respectively. and Erlandsson et al., 1989). Reported removal efficiencies range Approximately 80% of the radiotracers in the raw sludge were from 2% to 25% (Erlandsson and Mattsson, 1978; Erlandsson associated with the sludge solids. The affinity of the radiotracers et al., 1989; and Prichard et al., 1981). . for the activated sludge solids was in the following order: 58Co Confidence in results. Few published data are available for > 134Cs > 1311. direct comparison to the findings of this study. However, the The primary treatment, secondary treatment, and overall re-results cited here are in general agreement With the findings of moval efficiencies are summarized in Table 3. The removal of studies that have examined the removal of metals by* conven-the radiotracers during primary treatment resulted from the par-tional wastewater treatment processes. tial removal of the incoming insoluble fraction. The removal of The number of duplicate samples was not sufficient to reliably soluble 58Co during secondary treatment was the major removal estimate the sampling errors associated with the sludge and mechanism for this radionuclide within the treatment plant.

• wastewater data. Furthermore, the errors associated with the Based on the findings of the tracer study, it is estimated that volume measurements and the predicted tracer concentrations approximately 30% of the 6°Co, 10% of the mes, and 3-5% of used in the removal efficiency calculations are not known. The the 131 1 that enter* the Oak Ridge Wastewater Treatment Plant activity balances-79% for 58Co, 97% for 134Cs, and 95% for 131 1-indicate that the sampling and analytical methodologies are removed from the wastewater during treatment.

were adequate. For 58Co and 134Cs, the overall removal efficien-cies obtained by two different approaches agreed closely. These Acknowledgments estimates 'were calculated using the total tracer quantities ob- Credits. This research was performed under appointment to served in the primary and secondary- sludge and the tracer quan- the Operational Health Physics Fellowship Program adminis-tities observed in the digested sludge. Both approaches yielded tered by Oak Ridge Associated Universities for the U.S. De-estimates of 31 % for 58Co. However, only 48% of the initial 58Co partment of Energy, and in partial fulfillment of the requirements tracer quantity could be accounted for in the treatment plant for the M.S. degree for Elisabeth Stetar in the Department of eflluent before the concentrations dropped below detectable lev- Radiological Health Sciences at Colorado State University. The els. Therefore, a 58Co removal efficiency of up to 52% cannot use of the radiotracers was performed under the authority of, be ruled out: For 134Cs, estimates of 11 % and 12% were obtained and in accordance with Tennessee Radioactive Materials License using the sludge data. Approximately 85% of the initial 134Cs #R-1918 l-L90. Radiological analyses were conducted in thefa-tracer activity was observed in tlie treatment plant eflluent; cilities of the Environmental Sciences Division of the Oak Ridge therefore, the overall removal efficiency for 134Cs is believed to National Laboratory, managed by Martin Marietta Energy Sys-be in the range of 11-15%. tems, Inc., under contract DE-AC05-84OR21400 with the U.S. 638 Water En11ironment Research, Volume 65, ,Number 5

Stetar et al. Department of Energy. The authors acknowledge the coopera- in Primary Sedimentation I. The Influence of Metal Solubility. Sci. tion of the City of Oak Ridge and the many contributions of Total Environ., 63, 231. Jack Robinson and the Oak Ridge Wastewater Treatment Plant Larsen, I. L., and Cutshall, N. H. (1981) Direct Determination of 7Be in Sediments. Earth Planet Sci. Lett., 54, 379. personnel. The authors also appreciate the contributions of Alan Mumma, R. 0., Raupach, D. C., Waldman, J.P., Tong, S. C., Jacobs, G. Payne who served as the project Radiation Safety Officer and M. L., Babish, J. G., Hotchkiss, J. H., Wszolek, P. C., Gutenman, played a key role in sample collection. The authors thank Debra W. H., Bache, C. A., Lisk, D. J. ( 1984) National Survey ofElements G. Shults for her assistance in scheduling and in the collection, and other Constituents in Municipal Sewage Sludges. Arch. Environ. cataloguing, and preparation of samples. The efforts of Ann E. Contam. Toxicol., 13, 75. Walzer and Steve Nold in the collection and preparation of sam- Nielsen, J. S., Hrudey, S. E., Cantwell, F. F. ( 1987) Prediction of Soluble ples are also appreciated. Publication No. 4125, Environmental Nickel Removal by Activated Sludge using Free Metal Ion Con-Sciences Division, ORNL. centrations. Water Sci. Technol., 19, 439. Authors. Elisabeth A. Stetar is a Health Physics Consultant Onishi, Y., Serne, R. J., Arnold, E. M., Cowan, C. E., Thompson, F. L. with Performance Technology Group, Inc. Harry L. Boston is ( 1981 ) Critical Review: Radionuclide Transport, Sediment Trans-port, and Water Quality Mathematical Modeling; and Radionuclide research staff, and lngvar L. Larsen is a research associate, En-Adsorption/Desorption Mechanisms. NUREG/CR-1322, PNL-vironmental Sciences Division, Oak Ridge National Laboratory. 4109, Pacific Northwest Laboratory, Richland, Wash. Michael H. Mobley is Director, Tennessee Division of Radio- Petrasek, A. C., Jr., and Kugleman, I. J. ( I 983) Metals removal and logical Health. Correspondence should be addressed to Elisabeth partitioning in conventional wastewater treatment plants. J. Water A. Stetar, Performance Technology Group, Inc., 1210 Seventh Pollut. Control Fed., 55, 1183. Ave. North, Nashville, TN 37208. Prichard, H. M., Gesell, T. F., Davis, E. D. ( 1981) Iodine-131 Levels in Submitted for publication February 20, 1992; revised manu- Sludge and Treated Municipal Wastewater Near a Large*Medical script submitted November 9, 1992; accepted/or publication No- Complex. Am. J. Public Health, 71, 1, 47. vember JO, 1992. The deadline for discussions of this paper is Rossin, A. C., Sterritt, R. M., Lester, J. N. (1982) The Influence of Process Parameters on the Removal of Heavy Metals in Activated November 15, 1993. Discussions should be submitted to the Ex-Sludge. Water, Air, and Soil Pollut., 17, 185. ecutive Editor. The authors will be invited to prepare a single Rossin, A. C., Sterritt, R. M., Lester, J. N. ( 1983) The Influence of Flow Closure for all discussions received before that date. Conditions on the Removal of Heavy Metals in the Primary Sedi-mentation Process. Water, Air, and Soil Pollut., 19, 105. Sodd, V. J., Velten, R. J., Saenger, E. L. (1975) Concentrations of the References Medically Useful Radionuclides, Technetium-99m and Iodine-131 Ault, M. R. ( 1989) Gamma Emitting Isotopes of Medical Origin Detected at a Large Metropolitan Waste Water Treatment Plant. Health in Sanitary Waste Samples. Radiation Protection Manage., 6, 48. Physics, 28, 355. Boston, H. L. (1988-1990) Department of Energy/City of Oak Ridge Stephenson, T., and Lester, J. N. ( 1987a) Heavy Metal Behavior During 1990 Sludge Monitoring Data. Unpublished data, Oak Ridge Natl. the Activated Sludge Process. I. Extent of Soluble and Insoluble Lab., Environmental Sciences Div., Tennessee. Metal Removal. Sci. Total Environ., 63, 199. Boston, H. L., Van Miegroet, H., Larsen, I. L., Walzer, A. E. ( 1990) Stephenson, T., and Lester, J. N. ( 1987b) Heavy Metal Behavior During Fate of Radionuclides in Sewage Sludge Applied to Land. Proc. the Activated Sludge Process. II. Insoluble Metal Removal Mech-Fourth Inter. Conj Environ. Contam., Barcelona, Spain. anisms. Sci. Total Environ., 63, 215. Durham, R. W., and Joshi, S. R. ( 1979) Radionuclide Concentrations Sterritt, R. M., and Lester, J. N. ( 1981) The Influence of Sludge Age on in Two Sewage Treatment Plants on Western Lake Ontario, Canada. Heavy Metal Removal in the Activated Sludge Process. Water Res. J. Radioanal. Chem., 54, 367. (G.B.), 15, 59. Erlandsson, B., and Mattsson, S. ( 1978) Medically Used Radionuclides Stoveland, S., and Lester, J. N. ( 1980) A Study ofFactors which Influence in Sewage Sludge. Water, Air, and Soil Pollut., 9, 199. Metal Removal in the Activated Sludge Process. Sci. Total Environ., Erlandsson, B., Bjurman, B., Mattsson, S. ( 1989) Calculation of Radio- 16, 37. nuclide Ground Deposition by Means of Measurements on Sewage Tchobanoglous, G., and Burton, F. L. ( 1991) Wastewater Engineering: Sludge. Water, Air, and Soil Pollut., 45, 239. Treatment, Disposal and Reuse/Metcalf and Eddy, Inc. Third ed., Halsey, R. ( 1986) The Sewage Sludge Contamination Problem in Oak McGraw-Hill Series in Water Resources and Environmental En-Ridge: Is the Regulatory Control Adequate? M.S. project. Dep. of gineering.McGraw-Hill, N.Y., 56. Eng., Univ. of Tennessee. Tennessee Division of Radiological Health ( 1984) Environmental Mon-Halsey, R. ( 1984) Oak Ridge Contaminated Sewer Inspection. Letter to itoring Data. Unpublished data, Div. Radiological Health, Tenn. Div. Radiological Health, Tenn. Dep. Environ. and Conserv., Dep. Environ. and Conserv., Nashville. Nashville. U.S. EPA ( 1977) Wastewater Treatment Facilities for Sewered Small Imhoff, K. R., Koppe, P., Dietz, F. ( 1988) Investigations on the Con- Communities, Process Design Manual. EPA-625/1-77-009, 7-1, centration of Radionuclides in Sewage Sludge of Ruhrvervand Cincinatti, Ohio. Wastewater Treatment Plants 1960 through to 1986. Water Res. U.S. EPA ( 1986) Radioactivity of Municipal Sludge. Office of Water (G.B.), 22, 1059. Regulations and Standards, Wastewater Solids Criteria Branch, Kempton, S., Sterritt, R. M., Lester, J. N. ( 1983) Factors Affecting the Washington, D.C. Fate and Behavior ofToxic Elements in the Activated Sludge Process. Wang, C.H., Willis, D. L., Loveland, W. D. ( 1975) Radiotracer Meth-Environ. Pollut. (G.B.), 32, 5 I. odology in the Biological, Environmental, and Physical Sciences. Kempton, S., Sterritt, R. M., Lester, J. N. ( 1987) Heavy Metal Removal Prentice-Hall, Inc., Englewood Cliffs, N.J. July/August 639

[][P2HU,D SCIENCE*INDUSTRY*MEDICINE*ACADEMIA 1601 West Fifth Ave

• SU,ffl 23ti11y 111 26 p4 *QQ Columbus. Ohio43212~61
• OFFICE OF SECRETARY OOCKETIHG & SERVICE BRANCH Secretary of the Commission U.S. Nuclear Regulatory Commission DOCKET NUMBER PR Washington, D .C. 20555 PROPOSED RULE...;;....:;.::_ 2 0__

Attn: Docketing and Service Branch ( sq F P. q I'-/~ Re: ANPR, Federal Register Vol. 59, No. 38, p. 9146, Disposal of Radioactive Materials by Release into Sanitary Sewer Systems The Ohio Radioactive Materials Users Group (ORMUG) is a non-profit, voluntary association of medical, industrial, university, utility, research organizations, and specialized individuals. Its main purpose is to support and assist public and private activities utilizing radioactive materials and in particular, development of a low level radioactive waste system for the State of Ohio. These activities are intended that such materials will be handled and disposed of in a safe and environmentally acceptable manner and as economically as possible, i. e. ALARA. The comments of the Board of Directors of ORMUG regarding the above cited Advance Notice of Proposed Rulemaking follow. The disposal of certain radioactive materials via sanitary sewer has been a part of licensed activities for many years. However, even longstanding practices must be periodically scrutinized. The current state of sanitary sewer disposal, including the processing of sewage and the ultimate disposal of the products of processing, is rooted in the past and may be due further review , in light of technological advances in both areas. First, it appears that the events cited in the case studies may have been the result of abnormal events. No amount of regulation, planning, or notification can prevent inadvertent releases as the result of a system failure or other error. Secondly, the revised 10 CFR 20 has reduced doses to the general public (including sewer workers) to 100 mrem/yr and the result has been substantial decreases in both ALI and DAC for all radionuclides. The regulations have also been changed regarding solubility and dispersibility , resulting in the closing of potential loopholes for disposal via sanitary sewer. As stated in the ANPR, most of the contaminants in the case studies are insoluble materials and would not meet current criteria. Given these modifications , it seems unlikely that the types of contamination events cited would occur under the current regulations . Therefore, the "problem" may have been fixed by the recent regulatory changes and clarifications, but not enough time has passed to make that determination definitively . No information has been presented documenting radioactive contamination problems at publicly owned treatment works (POTW) later than the mid-1980s . What has occurred in the interim? Resources need not be expended on a "problem" that may already be fixed . Before proceeding with any actions, a study should be made of the extent of sanitary sewer disposal practices and determine the current status at POTWs with regard to radioactive contamination. Acknowledged by JUL 2 1 1994

                                       \ \o ti . .... .

DOCl\t 111 u Ill .:>t:hVICE: SECTION OFFICE Of THE SECRETARY OF THE COMMISSION Document Stattstics Postmar1< Dale J...:.../-1.. __._-=-

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ORMUG, Sanitary Sewer Disposal Comments Page 2 of 3 It should also be noted that not all licensees use the sanitary sewer for disposal. The cited 23,000 licensees may tend to overstate the problem potential and cause undue alarm. An initial step could be identification of those licensed activities which use sanitary sewer disposal. Licensing guidance provided by NRC could outline the information required for control of materials released by sanitary sewer, how this should be evaluated by a licensee, and how it would be best documented in any new license or renewal application. This would not result in an immediate, high-impact compliance burden, but a program of conversion phased-in over the period of license renewals. The petition for rulemaking proposed by the Northeast Ohio Regional Sewer District (NEORSD) is not an acceptable request. The twenty-four hour notification requirement would have no practical effect, since non-routine events know no schedule, and it must be presumed that normal operations under today's standards would not result in contamination of POTW facilities. A requirement for notification of the POTW would place undue burden on the licensee, both administratively and operationally . It would also serve to dilute the authority of the NRC, and place a measure of control for the use of radioactive materials, as well as the operation of licensee facilities, in the hands of individuals not empowered or qualified to have it. The additional requested exemption for all POTWs that incinerate sludge to do so without regulation, is also without merit. This would only serve to provide an open-ended system for radioactive materials to pass into the environment and to the public without limitation or characterization. Responsibility for public health and welfare is not solely in the hands of the NRC or the licensee. The POTW operators certainly must now account for non-radiological materials in sludge and take steps to limit their dispersion. Radioisotopes are readily identifiable compared to the chemistry that must be done for other contaminants and could be included as a routine analysis. Sludge should be sampled prior to incineration or other treatment in order to limit dose to the general public, in accordance with the same limits and regulations as those individuals utilizing radioactive materials . There has been an assertion by some that sanitary sewer disposals will be used as a means of relief from the current status of LLR W disposal. This suggestion is absurd and demonstrates little understanding of the nature of radioactive materials and LLRW. If the solution to waste disposal problems were indeed that simple, it would be a great revelation to thousands of radioactive material users throughout the region. In fact, such a means of disposal is specifically prohibited by the regulations. The exemption for patient excreta should be left intact for the present. No modeling has been done regarding these releases, and due to the sheer number of events and the randomness of the occurrence it may be very difficult. Lacking any definitive information, we should be wary of placing additional burden on the medical system. Certainly patients cannot be asked to monitor and record their "disposals" so the responsibility falls to the physician/hospital. This would only serve to drive up costs to individual patients, influence insurance costs, and perhaps affect the level of care given. In summary, the disposal of radioactive materials via sanitary sewer i§ in need of review. However, before changing current practices, an evaluation should be made of the status of radioactive contamination events at POTWs. Given a lack of information regarding current radioactive contamination events, and that the regulations have been significantly changed since the last identified contamination, this would seem a reasonable starting place. The proposal from NEORSD is not an

ORMUG, Sanitary Sewer Disposal Comments Page 3 of 3 acceptable approach to the control of radioactive materials and should not be given further consideration. The current exemption for patient excreta should remain unchanged until a control plan and guidance for other materials is established and impact on health care can be assessed . You may contact me at 614-424-7959 , or at the above address, if discussion of these comments is desired. Thank you. Sincerely, 14~ Timothy A. Walker, Vice-Chairman Ohio Radioactive Materials Users Group

Oncogene DOCKETED Scien\.~~ US NRC "94 M/\Y 25 P4 :01 0) OFFI CE OF SECRETARY OOCK ETlr-JG & SERV ICE BR ANCH May 24, 1994 DOCKET NUMBER Secretary of the Commission PROPOSED RULE PR ,2. 0 US Nuclear Regulatory Commission (S°/ FR 91'-/4) Washington, DC 20555 Attention: Docketing and Service Branch Commissioners: This letter is in response to your request for comments on the current policy for disposal of radioactive material by release into sanitary sewerage systems. The following points outline our position on this issue: ( 1) Form of material released: The most recent regulations restrict sewerage disposal to materials that are soluble or readily dispersible biological materials. We believe that any prior concerns for concentration of non-biological readily dispersible material are resolved by the new restriction to biological materials and are unaware of any significant problems with soluble material. We therefore recommend that you continue with this allowed release form. (2) Total quantity of material: Although these unchanged limits easily meet the needs of most licenses, it seems appropriate, given the new restriction on form of material released and the new more restrictive release concentrations, to consider relaxation of these limits for large users since reconcentration should be much less of a concern. It may even be practical to eliminate such an upper cap totally, depending only on concentration restriction with the reduced limits now in effect. As an organization with only a few users and with very low disposal, we have never seen the logic in applying the same cap to a large program with thousands of users as is applied to a small one with only a few users. (3) Types of limits: The present method of limitation based on an individual being exposed by ingestion of water from the sewer outfall seems to be sufficiently conservative to satisfy all needs, particularly in view of the new lower release concentrations. This is readily controllable in the workplace and is easily understood for radionuclide users. Proper adherence to concentration limits would appear to negate the need for an upper cap as mentioned in item 2 above.

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• I '-' *{' 'vtiM 155iON 00 *,<E. *" !, ~l::.11.JiCE SECTION OFf-11..t OF THE SECRET~RY OF THE COMMISSION

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Oncogene Scien~if'~ (page 2) (4) Exemption of Patient Excreta: Continuation of this important exemption is encouraged as a significant ALARA consideration. Collection and control of patient excreta would result in the deliberate reconcentration of a significant waste stream with the potential for worker exposure, spills, and emergency issues that have been avoided through the judicial use of this exemption. The rapid dispersal of this soluble waste stream of short-lived material seems the most practical approach to this issue and we strongly recommend the continuation of the exemption in its current form. We thank the commission for the opportunity to comment on this important issue and look forward to commenting on any proposed regulations that are forthcoming.

                                                                 ~              ;f~

David E. Hill, Ph.D. Radiation Safety Officer Oncogene Science, Inc. 80 Rogers Street, Cambridge, Massachusetts 02142 (617) 492-7289

• Fax (617) 492-8438

DEPARTMENT OF VETERANS AFFAIRS Medical and Regional Office Center White River Junction VT 05009 DOCKETED us~;:; ~ Q DOCKET NUMBER PROPOSED RULE PR 20 *94 MAY 25 P3 :42 May 24, 1994 (5"Cf FP. 9/'i~ In Reply Refer To: OFF ICE OF ,._i:CP.EfARY

• OOCK ETit G & ~,FRV ICE Secretary of the Commission U.S. Nuclear Regul atory Commission B AHCH Washington, D.C. 20555 Attention: Docketing and Service Branch

Dear Sir/Madam:

This is in response to the request for comments on the current policy for disposal of radioactive material by release into sanitary sewerage systems. Following is our position on this issue:

1. Form of material released: The most recent regulations restrict sewerage disposal to materials that are soluble or readily dispersible biological materials. We believe that any prior concerns for concentration of non-biological readily dispersible material are resolved by the new restriction to biological materials and are unaware of any significant problems with soluble material. We therefore recommend continuation of this allowed release form.

2. Total quantity of material: Although these unchanged limits easily meet the needs of most licensees, it seems appropriate, given the new restriction on form of material released and the new more restrictive release concentrations, to consider relaxation of these limits for large users since reconcentration should be much less of a concern. It may even be practical to eliminate such an upper cap totally, depending only on concentration restriction with the reduced limits now in effect. We have never seen the logic in applying the same cap to a large program with thousands of users as is applied to a small one with only a few users.

3. Types of limits: The present method of limitation based on an individual being exposed by ingestion of water from the sewer outfall seems to be sufficiently conservative to satisfy all needs, particularly in view of the new lower release concentrations. This is readily controllable in the workplace and is easily understood for radionuclide users. Proper adherence to concentration limits would appear to negate the need for an upper cap as mentioned in item 2 above.

4. Exemption of Patient Excreta: Continuation of this important exemption is encouraged as a significant ALARA consideration.

Collection and control of patient excreta would result in the deliberate reconcentration of a significant waste stream with the potential for worker exposure, spills, and emergency issues that Ackn wlldged by al'd ....:...:! 1994 '""""'

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• __ . , ..,nf C.OMMISS!ON DOCKETING & SERVICE SECTION OFFICE OF THE SECRETARY OF THE COMMISSION Document StatisticS

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have been avoided through the judicial use of this exemption. The rapid dispersal of soluble waste stream of short-lived material seems the most practical approach to this issue and we strongly recommend the continuation of the exemption in its current form. We thank the commission for the opportunity to comment on this important issue and look forward to commenting on any proposed regulations that are forthcoming. Sincerely.

                                   ~~{~

Radiation Safety Officer

From: Donald R. Saxton, RSO (802) 296-6396 Office of Radiation Safety Veterans Affairs Medical Center North Hartland Road White River Junction, VT 05009 To: Secretary of the Commission U.S. Nuclear Regulatory Commission Washington, D.C. 20555 Att: Docketing and Service Branch

SAINT BARNABAS MEDICAL CENTER RONALD J. DEL MAURO

                                                                                          *94 MAY 25 P3 :42                       DEPARTMENT OF RADIOLOGY President and Chief Executive Officer                                                                                                             Letty G. Lutzker, M.D.

Chier of Nuclear Medicine May 24, 1994 OFFI CE OF SEC.:q_ETARY (201) 533-5957 OOCKE fl HG & 'Jt / ICE BR AHCH Secretary of the Commission DOCKET Nur,;8ER PR "'1 O United States Nuclear Regulatory Commission PROPOSED RULE..;:...;:.;;._.,L_ . __ __ Washington, DC 20555 (51FR q,L/&) Attn: Docketing and Service Branch: Gentlemen: I am very concerned about the proposed rulemaking published in 59 FR 9146 on February 25, 1994, specifically the possibility that the Commission may eliminate the exemption for disposing of patient excreta into the sanitary sewage systems. It is no exaggeration to state that this action would lead to the elimination of clinical nuclear medicine practice in the United States. Should the exemption be dropped, hund r eds of gallons of urine and feces would have to be stored in the elaborate holding tanks with extensive monitoring systems in every clinical installation, hospital, clinic, or office. The biomedical hazards would be enormous, the radioactive hazard minimal, though greater than the nonexistent hazard currently posed by disposal into the sanitary sewage sys t em. Outpatient studies would pose additional problems. Would patients be required to store their excreta at home, or be require d to bring it back to the facility where they were scanned? Would the homes of patients have to be monitored by government officials for proper waste disposal? The logistics of the proposed policy would be ridiculous, the costs untenable if implemented, and likely result the curta i lment of valuable clinical evaluations and the obliteration of a well recognized and safe medical specialty. There is no public health threat created by the current exemption. Please consider the consequences of this proposal, and maintain the current common sense and scientifically defensible policy. Sincerely yours, 4 Letty G. Lutzker, M.D. Chief of Nuclear Medicine Department of Radiology LGL/cs 1077R JUL 2 1 1994 Acknowledged by card........................ ..... OLD SHORT HILLS ROAD LIVINGSTON.NEW JERSEY 07039 (20 1) 533-5000 A nonprnfit. rn1nscc*tarian medical crntcr, founded in 1865. and a major affil iate of the University of Medicine and Denti ,try of New Jcrse)

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                                                                                               *94 M~Y 24 p 3 :46
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617 631:1-7052 OF FICE OF SECRETARY Nuclear Regulatory Commission OOCKETWG & SERVICE Secretary of Commission OCKET NUMBER BRANCH Washington, D. C. 2 O5 5 5 PROPOSED RULE PR 2.. 0 Attn: Docketing and Service Branch ( !iCf FR CJ IL/G May 20, 1994 Disposal of Radioactive Material by Release into Sanitary Sewerage Gentlemen: We are a large medical research institution using radio-isotopes for medical research and in patients. We are opposed to further rulemaking revi s ing the curre nt r e gul a tion s relating to disposal of radioactive material by release into the sanitary sewerage system as proposed in the Feb. 25, 1994 Federal Register. In Massachusetts we have been denied access of our low-level radioactive waste at the Barnwell disposal facility. Further restrictions on radwaste disposal via limita tions on sanitary sewerage disposal will create further hardship in an already crisis situation. I have specific comments relating to this proposal. Exemption of Patient Excreta a) Attempts to control excreta from diagnostic patients administered radiopharmaceuticals seems ludicrous. Millions of patients are administered diagnostic radiopharmaceuticals. Having an institution trying to control for example urine from bone imaging patients either at the institution or having urine returned from their home to the institution is not a reasonable request.

1) Handling urine represents a potential biohazardous material.

2) The radionuclides administered are short-lived and thus the exposure potential to all is short lived including sewerage treatment facilities which appear to be remote operations.

b) Attempts to control excreta from therapy patients represent a greater exposure potential to the institution than remote sewerage operations. The radionuclide of concern here is I-131. Acm>wtedg by cm-d .....filtJl..1.....:.....

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1) We would have to store urine for decay up to 2 months. Would you want to handle 2 month old urine?

2) There is exposure potential to staff of having to handle and store large millicurie quantities of this potential biohazardous waste. Thus lead bricks will be needed to shield carboy quantities of radioactive urine.

3) There is potential of radioactive volatility from opening when continually adding to a patient urine container.

4) There is a possibility of spilling radioactive urine during processing.

5) Receiving urine from radioiodine outpatients (hyperthyroidism treatment) doesn't appear to be ALARA to our institution. How will the patients comply let alone try to shield this material?

6) Costs to patients will go up to provide further radiation safety precautions for stored urine. There is a net benefit from medical diagnosis and treatment with radiopharmaceuticals that exceeds any minuscule risk from controlling exposure potential from radioactive excreta to a small segment of sewer treatment personnel or sludge.

I have not addressed radioactivity in feces. Please! c) Disposal of Soluble Aqueous Medical Research Waste At our institution we dispose of trace levels of soluble radionuclide solutions down "hot sinks* The amounts disposed are trivial compared to radioactive excreta from patients. We have already stated the benefit for patient use of radiopharmaceuticals. There are benefits to using radionuclides in medical research since almost all grant recipients in this institution need to use radionuclides for their research. If radioactive disposal was limited or eliminated this will severely affect our medical research since we will have no way to get rid of certain classes of radwaste at our institution needed for medical research. We have millions of dollars in research grants. sv~ ' Victor Evdokimo ff Director Radiation Protection, BUMC

oOCKt r NUMBER PR 2 0 PROPOSED RULE,.!...!!..-=:-- - ( 5'1 f R q1'-!') OOCKfTEO USNR

                                              *g4 MOY 24 9 2 *Q5 11W~E,Bl~ ~m~!~!!

May ~ , 1' 94 Tel.(617)322-4885 Telex: 200049 Answerback: PENZUR Secretary of the Commission Tele Fax (617) 322-3141 US Nuclear Regulatory Commission y snington, DC 20555 Attn: Docketing and Service Branch Sir/Madam: This is in response to the request for comments on the current policy for disposal of radioactive material by release into sanitary sewerage systems. Following is our position on this issue: (1) Form of material released: The most recent regulations restrict sewera9e dis~osal to materials that are soluble or readily dispersible biological materials. we believe that any prior concerns for concentration of non-biological readily aispersible material are resolved by the new restriction to biological materials and are unaware of any significant ~roblems with soluble material. We therefore recommend continuation of this allowed release form. (3) T¥pes of limits: The present method of limitation based on an individual being exposed by ingestion of water from the sewer outfall seems to be sufficiently conservative to satisfy all needs, particularly in view of the new lower release concentrations. This is readily controllable in the wo rkplace and is easily understood for radionuclide users. (4) Exemption of Patient Excreta: Continu ation of this important exemption is encouraged as a significant ALARA consideration. Collection and control of patient excreta would result in the deliberate reconcentrati.on of a signific ant waste stream with the potential for worker exposure, spills, and emergency issues that have been avoided throo9h the judicial use of this exemption. The rapid dispersal of this soluble waste stream of short-lived material seems the most practical approach of this issue and we strongly recommend the continuation of the exemption in its current form. we thank the commission for the opportunity to comment on this important issue and look forward to commenting on any proposed regulations that are forthcoming. Sincerely, The Enzyme Center UaJR.fL,n, Ji,~

                                                               ~~~y David Radiation                Manager DRL/cw JUL 2 1 1994 Enzymes, Diagnostic Reagents and Kits mowtedg    d......         * ............

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0 C~AR CIE CE C. 36 FRANKLIN STREET, MALDEN, MA 02148-4120 U.S.A. *qJEL: ~ 17l~2:;f>]52~ 5 FAX: (617) 322-3141 May 20, 1"994 CE Of 5s=(RETARY Secretary of the Commission ib~KET I lG & SERVICE US Nuclear Regulatory Commission DOCKET NU ~~CH Washington, DC 20555 PROPOSED RULE P 5 /1 /qL/ (S-CfF~ CfJLf~ Attn: Docketing and Service Branch Sir/Madam: This is in response to the request for comments on the current policy for disposal of radioactive material by release into sanitary sewerage systems. Following is our position on this issue: (1) Form of material released: The most recent regulations restrict sewera~e dis~osal to materials that are soluble or readily dispersible biological materials. We believe that any prior concerns for concentration of non-biological readily aispersibl e material a re resolved by the new restriction to biological materials and are unaware of any significant ~roblems with soluble material. We therefore recommend continuation of this allowed release form. (3) T¥pes of limits: The present method of limitation based on an individual being exposed by ingestion of water from the sewer outfall seems to be sufficiently conservative to satisfy all needs, particularly in view of the new lower release concentrations. This is readily controllable in the workplace and is easily understood for raaionuclide users. (4) Exemption of Patient Excreta: Continuation of this important exemption is encouraged as a significant ALARA consideration. Collection and control of patient excreta would result in the deliberate reconcentration of a significant waste stream with the potential for worker exposure, spills, and emergency issues that have been avoided throu~h the judicial use of this exemption. The rapid dispersal of this soluble waste strecm of short-li~ed material seems the most practical approach of this issue and we strongly recommend the continuation of the exemption in its current form. we thank the commission for the opportunity to comment on this important issue and look forward lo commenting on any proposed regulations that are forthcoming. Sincerel¥, Charm Sciences Inc. i)JRRJh"':i(L David Quality Assii~~ce Manager DRL/cw

May 13, 1994 DOCKETED Secretary of the Commission US RC

                                                '94 MAY 23 P4 :27 G   +-

ROEDIGER rm, -

rm:, W: -:m:, SW :m, W: :rm:, SW:-

Equipment for Wastewater Treatment Nuclear Regulatory Commission Washington, o.c. 20555 DOCKET NUMBER Attention: Mr. Ivan Selin PRoPosEo RULE PR :i..o .__

Subject:

Disposal of Radioactive.., Hots pi tal Sewage ( S '=t f R CJ IL/ IJ

Dear Mr. Selin:

We have been advised of recent concerns regarding disposal of radioactive body waste generated by hospital patients. Typically, that radioactive waste is disposed of in municipal wastewater treatment plants. The concerns are for contamination of the treatment plants, the employees and the environment beyond the plant discharges. We are manufacturers of wastewater treatment equipment and are totally owned by Roediger Anlagenbau - GmbH of Hanau, Germany. Roediger is the market leader in wastewater treatment technology throughout the world. That technology includes design and installation of decontamination . units for treatment of body waste generated by nuclear medical departments of hospitals. Germany has had, for some time, governmental regulations (Strahlenschutzverordnung) demanding that such waste from hospitals be treated regarding radioactivity prior to release into the municipal sewage system. Roediger has nearly fifty such treatment facilities in successful operation in Germany and Austria. We attach that installation list. The purpose of this letter is to advise that the technology required is existing and readily available to you. The engineers and scientists of Roediger would be pleased to meet with you at any time and location to discuss the matter. Please use this office as a primary contact to arrange for a meeting. We would like to work with you toward our common goals. Very truly yours,

                                                "~'         GER PITTSBURGH, INC.
                                                  ~::::---~=;5;;::~::,l!I~~

Norman w. Teslik Executive Vice President NWT/jt cc: Roediger Anlagenbau GmbH/Gerhard Kohlenberger Nuclear Regulatory Commission/Docketing & Service Branch Roediger Pittsburgh, Inc. 3812 Route 8 Allison Park, PA 15101 Telephone: (412) 487-6010 Fax: (412) 487-6005 JUL 2 t 1

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                ~B :,i:;c~:Ji. UTILITY 01sTn1cT ( 5 '1 FR q/3/ 6)                                               MICHAEL J. WALLIS 00cHE f'EoOROF WASTEWATER USt1RC May 16, 1994 The Secretary of the Commission U.S. Nuclear Regulatory Commission Washington, DC 20555 Attention: Docketing and Service Branch Thank you for the opportunity to submit comment on the Nuclear Regulatory Commission (NRC) proposed rulemaking. East Bay Municipal Utility District (District) staff have reviewed the proposed rule and have the following comments.

The District has not performed any sampling on its various plant process streams to determine if any radioactive materials are detectable. It is known, however, that more than 20 small research-oriented NRC license holders are located within the service area boundaries. Legislation regulating types and quantities of discharges should be considered only after completing a thorough health risk assessment.

GENERAL COMMENT

S Shortage of data:

• The NRC should fund and initiate a phased study to determine the fate of radionuclide discharges to the sanitary sewer. The initial phase should establish a nationwide database, similar to the EPA Toxic Release Inventory. This data would allow the NRC to identify who is discharging what materials and which POTW's are impacted.

A second phase of the study would investigate those impacted POTW's and the fate of the various radionuclides on their influent, residuals and outfall. Requirements should be placed on the pollutant sources prior to entering the sewers to prevent the need for controls at POTWs. Future POTW Regulations:

• The NRC should coordinate any future regulations affecting the sanitary sewer discharges with EPA requirements for Clean Water Act discharges, including Categorical Standards, NPDES permits and Sludge regulations.

POTW Impacts:

• Any regulations promulgated by the NRC should ensure that POTW s are not impacted and clearly show compliance at the sources. The costs of data collection, data reporting and worker training should be borne by NRC license holders.

P.O. BOX 24055. OAKLAND

• CA 94623-1055 * (510) 287-1405 BOARD OF DIRECTORS KATHERINE McKENNEY, STUART FLA SHMAN
• ANDREW COHEN JOHN A. COLEMAN
• JOHN M. GIOIA , NANCY J. NADEL
• KENNETH H. SIMMONS Recycled Paper JUL 2 1 1994 Acknowledged by card ......."..*"-'"""'"..."

D<.,  :..:RVICE SECTION CH,, a:. .JF THE SECRETARY OF THE COMMISSION Docu-ncnt Statistics Postmark Oat 5 / t 1 qq Coples Aecc* c___,______ NJ I Coples Reprc Sp I I Dl * "':. ..,, J : ; : : : , ~ ~~ !,,c..;..;J-- __p__z;.µe.,."'-r...J-_

The Secretary of the Commission U.S. Nuclear Regulatory Commission Page 2 SPECIFIC COMMENTS Current Regulation Basis:

• Section 2.2 of Evaluation of Exposure Pathways to Man From Disposal of Radioactive Materials Into Sanitary Sewer Systems describes present regulations controlling discharges of radionuclides. The current limitations do not properly reflect the hazards of radioactive materials behavior in a POTW nor release to the environment.

An appropriate study would include: 1) POTW hazard identification; 2) A relevant exposure assessment; 3) toxicity assessment; and 4) a risk characterization. In addition, District experience has shown that the type and mass of pollutant is of greater importance to the POTW than that volume of discharge. Future limits should consider the type of radionuclide discharged and POTW specific parameters, including outfall restrictions, sludge handling processes and sludge disposal methods. Future Regulation:

• In regards to the Northeast Ohio Regional Sewer District petition recommending 24 hour advance notification to the affected POTW, EBMUD would support a reporting system for releases which could cause a threat to the POTW workers or environment.

If you have any questions or comments please contact me at 510/287-1630. Sincerely, ~GP~ THOMAS C. PAULSON Supervisor Industrial Discharger Section TCP:WEM:wem

                                                    ~~g~61t~~~:,a 2-0 UNIVERSITY OF CALIFORNIA, BERKELEY                                 (5 "f F {< °II~~- - DOCKETED

_./

                                                                                    / -.:,.<,;.
                                                                                                         "* c:.,*-.,\ US ,,JRC

- - - - - - - - - - - - - - - - - - - - - - - - fi 11\--------- BERKELEY

• DAVIS
• IRVINE
• LOS ANGELES *RIVERSIDE* SA N DI EGO
• SAN FRANCISCO \ 7 O l SANTA BARBARA* SANTA CRUZ

---

\~ //---------

                                                                                     . . .,.,:.... .___. . -~./MAY 20 A10          :so OFFICE OF THE PROVOST FOR RESEARCH                                            BERKELEY, CALIFORNIA 94720 TELEPHONE: (510) 642-7540 FACSIMILE: (510) 643-5620 OFFi CE                 or SECRETARY DOCKETING & SERVICE May 12, 1994                                BRANCH Samuel J. Chilk The Secretary of the Commission United States Nuclear Regulatory Commission Washington, DC 20555 Attention: Docketing and Service Branch RE:        Comments on Proposed Change to 10CFR20 Disposal of Radioactive Material into Sanitary Sewer Systems

References:

Advance Notice of Proposed Rule Making in Federal Register Vol. 59, No. 38, Page 9146 (BIN 3150-AE90) NUREG/CR-5814, Evaluation of Exposure Pathways to Man from Disposal of Radioactive Materials into Sanitary Sewer Systems

Dear Secretary Chilk:

The February 25, 1994, Federal Register announced advance notice of proposed rule-making related to the disposal of radioactive materials to sanitary sewers. The FR asked for comment from interested parties; we offer these comments for consideration. Although the sewer disposal limits of 10CFR20.2003(a)(4) were increased on January 1, 1994, our State of California sewer disposal limit remains at one Curie per year. We are concerned that the Commission may significantly reduce the limits in Part 20.2003--Disposal by release into sanitary sewerage. We believe that, in many cases, sewer disposal of these materials results in the lowest reasonably achievable dose. We believe that our releases of radioactive materials into the sanitary sewer are typical of a research university (with no hospital). Historically, we have seldom disposed of more than 20% of the one Curie limit per year. The majority of our discharges are short half-life P-32 and S-35, with H-3, and other miscellaneous isotopes. Our discharges are diluted in our sanitary sewerage (almost a million gallons per day) and then flow to a high volume public sewage treatment plant where they are further diluted with discharges from the city of Richmond and Oakland. We have not been able to identify pathways to human dose for either sewage treatment workers or members of the general public. There does not appear to be a process by which any significant re-concentration of our release in the sludge AcKnowlidged by

                                                                                                                         .. JUL 2 1 1994

lij.:::. hv ~-- ' *- I JO \~ vL*MMISSION 0OCK!::i 1* lG .r~ SF.RVICE SECTION OFFICE OF THE SECRETARY OF THE COMMISSION D"~ument Statistics Postmark Date l L ~L/ Copies Reech,, d_ __ ,_ _ _ __ Add'! Copies Reprodu:: d -=--- - - -- ~ JU, o~, etJn;

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page2 Samuel J. Chilk May 12, 1994 could occur. If re-concentration did occur, the doses would be only fractionally above background. In short, we believe that our sink disposal of these low level, primarily beta emitters reduces both cost and lab worker exposure; therefore, we believe that our process provides doses that are ALARA. Our concern with the notice of proposed rulemaking is that lower, perhaps much lower, numerical limits will be adopted into Part 20.2003. Agreement states will comply and some may further reduce these limits. Lowering th e limits could place a significant burden on us; a burden that can not bP. justified if the ALARA concept is included. If it is decided that the numerical limits (10CFR20.2003(a)(4)) are not providing adequate protection from radiation for workers or members of the general population, we suggest that the Commission consider extending the dose calculation concepts in Part 20.1203, Part 20.1204, and 10CFR50--Appendix I to the sewer disposal of radioactive materials. A simplified version of Regulatory Guide 1.111 could be developed to aid licenses and regulators to project and to demonstrate that routine releases comply with the dose limits of 10CFR20. If you have questions or want additional information please contact our campus Radiation Safety Officer, Paul Lavely at (510) 643-7976. Sincerely, joseph Cerny ~ Provost for Research cc Paul Lavely, Radiation Safety Officer

May 13, 1994 *94 f1 Y 18 P3 :4 4 The Secretary of the Commission U.S . Nuclear Regulatory Commission Washington, D.C. 20555 Attention: Docketing and Service Branch

Dear Sirs,

The following comments are provided on proposed rule making governing release of radioactive materials to the sanitary sewer system as described in the Federal Register, Vol. 59, No. 38, dated Friday, February 25, 1994. The issue of discharge to the sanitary sewer system is complex. I can empathize with the difficulty in dealing with the issue, and appreciate the efforts of the Commission to implement a consensual rule-making process. A thorny predicament exists between those in the industry who already feel over-regulated, and the municipalities and anti-nuclear activists who allege that the NRC has failed in its duty to control the release of radioactive material. Interstate Nuclear Services (INS) serves the nuclear industry from 14 locations situated throughout the United States. Our principle service is the decontamination (laundering) of protective clothing for approximately 80% of the domestic nuclear industry. INS decontamination processes use specialized water-based wash formulations. Water is a vital resource used in INS operations. Depending on the facility, water use ranges from 5,000 to 50,000 gallons per day. Thus, the ability to discharge treated wastewater to the sanitary sewer system is paramount to the Company's ability to continue in business. Further restrictions which limit discharge to the sewer could lead to dire consequences for INS, and in many ways, the entire nuclear industry. I As a preface, I would like to provide a bit of perspective. I hold the position ofManager, Health Physics and Engineering at INS and among other responsibilities, I am in charge of the overall health physics program for the entire company. While I have a fiscal obligation to serve the Company, my principal responsibility lies in the health and safety of our employees, the general public and the environment - a conviction the Company strongly supports. Because of my position, one might anticipate a self-serving resistance to change as would be expected of a licensee that is asked to alter the status quo, or expend significant resources to remedy a situation. However, INS is amenable to change for the good, if it is based on technical reasons. After reviewing government reports and various pathway analyses, and following the issue closely throughout the years, I am beginning to question the motivation behind further restrictions. While I admit that there is evidence of radioactive material accumulation in sewer lines and at treatment facilities (is anyone surprised?), I am hard-pressed to find a health physics-related reason for change. Everything I read seems to indicate that the levels found in sewerage and sludge is of little dose consequence, except when examined using wild and exaggerated assumptions. 295 Parker Street

• P.O. Box 51957
• Springfield, Massachusetts 01151 * (413) 543-6911
• FAX: 413) 543-6989 I\M 1 *L-....................

                                                                                          ........ 1194 ..

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Page 2 of 8 Without question, the discharge of metallic chunks and machining byproducts, or any attempt to circumvent solid radioactive waste disposal by using the sewer must be eliminated. Excepting those situations, where does prudent regulation lie? To what extent should discharge to municipal sewer systems be minimized? Is it based on dose to the theoretical maximally exposed individual? Is it based on an economic level vis-a-vis ALARA and dollars per man-rem saved? Or, is it based on political consensus whereby most parties will be appeased? This fundamental question must be answered before a logical solution can be derived. As a health physicist, I profess that the solution should reside in delivered dose/calculated risk basis. As a businessman, I believe that it should be founded in an economic cost-benefit system similar to the EPA's method of best available technology determination. As an experienced licensee however, (despite the Commission's earnest attempt to the contrary), I fear that the "solution" will emerge as a political resolution, and technical rationale will only surface as a secondary consideration. In reflecting on the recently enacted change eliminating the "readily dispersible" option, I do not believe that the regulating community "fixed" the problem with a pen-and-ink change to the statute. I strongly suspect that even a perfectly soluble discharge will precipitate upon encountering an increase in pH, or complex with an organic or inorganic compound, or be taken up as a trace element by a microorganism, or plate-out on an inviting surface, or otherwise accumulate by some type of physio-chemical process. Even if this were not to happen by chance, once at the treatment works, the wastewater would be treated with coagulants and tlocculants, specifically designed to encourage accumulation of material. Short of zero discharge, material accumulation in the sewer will continue. While zero discharge will satisfy the anti-nuclear factions and nervous municipalities, it will put the industry into an early grave. Therefore, the Commission must establish a decisive regulatory position that will not waver every time someone finds a bit of radioactive material in a sewer. Encouraging (or forcing as may be the case) licensees to further restrict the form, quantity and/or concentration of radioactive materials in etlluent will increase the need for capital and radioactive waste-intensive technologies. There is a point of diminishing returns. Balanced against the real risk from the low delivered dose, the expenditure needed for further abatement of etlluents quickly out-paces even conservative figures for dollars per person-rem saved. From the radioactive waste perspective, further etlluent restrictions will result in greater radioactive waste production. There is an exponential increase in the amount of waste produced with only an incremental increase in filtering efficiency. Creation of this "unnecessary" waste runs counter to the nation's radioactive waste reduction policy. It also adds to worker dose from additional waste handling resulting in an increase in collective dose. By imposing further restrictions, all that will happen is that the problem will be pushed elsewhere - from the NRC to the waste compacts, but in all cases it will land squarely on the licensee's back and pocketbook. There is a point where it does not make any sense to try to remove decreasingly small amounts of radioactive material - not from an economic view, and certainly not from a dose perspective. I believe that we are already at that point. In an attempt to specifically answer the Commission's request for comment regarding specific questions, I offer the following . I have repeated [paraphrased] the questions in italics.

Page 3 of 8

1) Form of the Material for Disposal To what extent and how [should} the regulations take into account the technologies for processing sewage including technologies such as bioprocessing or ion-exchange?

The Commission should consider modifying regulations to reflect the effects of advanced methods of water treatment based on the results of the recently commissioned Pacific Northwest Laboratory study - but only if it is found to be a real factor considering the statistical variation that will be expected in the systems examined. The Commission must also recognize that many of the newly-touted treatment schemes are still experimental, and have not yet proven to be economically-effective on a large scale, and thus may never be employed. Therefore, a "blanket" conservative factor should not be evoked to cover a worst-case treatment method. Instead, the Commission should evaluate the performance of various treatment technologies, and should try to derive a "technology-specific reconcentration factor" for different treatment schemes as compared to several forms and isotopes normally encountered. Using such an adjustment factor would allow a licensee to back-calculate the expected concentrating effects of discharges, and take appropriate pretreatment steps as may be necessary. [What areJ the potential impacts on [yourJ operations associated with any additional restrictions regarding the forms of materials suitable for dispersal? The potential impacts of further restrictions on form of materials would be devastating to INS, and likely to the entire industry. At INS, a wide variety of isotopes and forms are processed depending on the activity that the protective clothing was used for. Laboratory and large-scale studies conducted by INS revealed that although the mix of isotopes is fairly constant, there is a diverse array of forms. For example, many isotopes occur in both soluble form (salts) and insoluble form (oxides). Considering the large volumes of water processed, it would be impractical if not impossible to chemically analyze each tank of water prior to discharge. A further restriction in the forms of materials allowed to be discharged (or even the requirement to test for them) would paralyze INS operations and lead to rapid destruction of the Company. Protective clothing is a critical commodity. Most U.S. nuclear power plants and industries have lost or abandoned the ability to process protective clothing. Thus, the loss of INS and similar companies relying on sewer discharge would result in a significant blow to the entire U.S. nuclear industry.

2) Total Quantity of Material

[Is the approach acceptable?J The approach to limiting total quantity of material is sound but overly simplistic. One would expect that the lower the total quantity discharged, the lower the resultant build-up and dose

Page 4 of 8 delivered. Perhaps this is so. However, I suspect that due to the unique dynamics of each individual treatment system, it will be difficult to find a clear cause and effect. As a suggestion, the Commission should review how many licensees approach the limits, and determine if it results in reconcentration proportionate to the amount of activity being discharged. [Should] a total quantity to be released be ~pecified or otherwise limited? It is O.K. to stipulate a total quantity to be discharged as it provides a helpful benchmark to judge against. However, citing the outrageously conservative assumption that an individual receives all drinking water from the discharge pipe, it is relatively safe to say that the present limit is adequate from a dose perspective. [What about] an approach which might limit the total quantity of each radionuclide, based upon the biokinetics and health risk for each nuclide such as some multiple of the annual limit of intake values, or the related exempt quantities published in JO CFRpart 30? An approach that may limit the total quantity of each isotope is an approach to split the same hair in a different way. The system of ALI determination already considers biokinetics and health risks for each nuclide so what would change? The ALI approach is on the right track and in concert with the method in use in Europe. Their limits are all based on multiples of ALI. They are more concerned with the dose-related bottom-line. Form, concentration and total quantity are secondary, and are not given great emphasis. [What] are the potential impacts on [yourJ operations associated with further restrictions on the total quantity of [each radionuclide] radioactive material which could be released during the year? The impact on INS of limiting the quantity of radionuclides by isotope would also severely disrupt our ability to operate. While INS could live with slightly reduced isotopic quantity limits, we could not live with the requirement to isotopically analyze each tank prior to discharge. Presently, INS employs a method based on DOT shipping papers to identify a "most limiting nuclide". Gross discharge limits are established assuming that the entire tank contains the most limiting nuclide. This method satisfies a "go/no-go" release requirement. Concurrent with the gross analysis, a sample is collected and compiled into a composite which is sent-out for isotopic analysis for monthly compliance records. If a requirement to measure and limit discharges based on isotopic quantity were enacted, each INS facility would have to be equipped with an entire complement of sophisticated alpha, beta, and gamma isotopically-discerning analytical equipment. Notwithstanding the capital and operating expense of such systems, the time required to process samples between batch releases would be prohibitive, and would severely curtail INS's ability to operate. _J

Page 5 of 8 [Should] the total quantity of radionuclides that may be released to a sanitary sewer by a licensed nuclear facility take into consideration the capacity and treatment methods used by the water treatment plant that serves the licensee, and should consideration be given to the fact that many licensed facilities may discharge in the same sewer treatment plant? Consideration should be given to the capacity and treatment methods used by the water treatment plant that serves the licensee. The phenomenon of a large-fish-in-a-small-pond applies in this situation. This problem can be compounded if by coincidence there is an advanced treatment method in use. Review of municipal sewer system capacity and treatment methodology has become an important criterion in the INS site selection process for new facility development. This can and should be employed by the Commission in all future new facility licensing considerations. However, the problem for INS as well as the Commission is that there are a large number of existing facilities that are already in operation that never considered the receiving sewer system. It would not be fair to suddenly "target zone" these facilities out of business. There must be recognition of these cases and if it is a problem when compared to others, then a reasonable time to remedy the situation should be extended. Consideration should also be given to the fact that many licensed facilities may discharge into the same sewer treatment plant. As a suggestion, the Commission should set rules based on a reasonable number of anticipated users (eg. five) that may be on the same system, then allocate preestablished individual limits to allow each user 1/5 of the total quantity limit. This method is similar to the system of pollutant load allocation used by a municipal sewer system to comply with NPDES limits. I suspect that there are only a few municipalities where the preestablished allocation would be exceeded, (DOE related "campuses" and satellite businesses such as those at Oak Ridge). In these situations, the same methodology could be applied, but it should be done on a case-by-case basis so as not to overly-restrict other licensees. [What about the Northeast Ohio Regional Sewer District petition to require 24 hour advance notice prior to discharge]? Don't open Pandora's box! Although a subject of dispute, in my opinion, 10 CFR 8.4, "Jurisdiction over Nuclear Facilities and Materials Under the Atomic Energy Act", does not preempt a municipality from imposing additional sewer restrictions on a permittee. Disposal of waste into the sewer is akin to driving - it is a privilege, not a right. A municipality owns the sewer, and can exercise control over their domain. Carefully worded, a sewer permit can impose an imaginative array of restrictions, and it is not inconceivable that they could require a 24 hour notice prior to disposal of anything, including radioactive materials. Therefore, it would be best to leave this option to the locals. It would be dangerous to mandate that every sewer district require and receive advance notice. Some may not care, some may not be equipped either intellectually or administratively to handle the information, others may prefer to rely on the current system ofNRC or agreement state regulation. Moreover, what will happen when a local sewer employee who may not understand the issue decides to "play God"

Page 6 of 8 and hold a licensee hostage by prohibiting discharge? Will the NRC become the arbitrator? Who will bear the cost oflost business? Without clearly established law regarding criteria for limiting disposal, the policy would be ripe for abuse. The NRC does not need to become embroiled in this issue by entering the fray.

3) Type of Limits Should the Commission continue an approach of limitation based upon an individual being exposed by the ingestion of water from the sewer outfall?

No. Setting regulations based on such an extremely conservative case is one of the reasons that dose calculation models lack credibility. Efforts should be made to recognize a realistic ingestion pathway and use that assumption to set limits. (Realistic models provide at least a one million dilution factor between the discharge point and receptor.) If realism is incorporated however, I believe that the Commission will be reminded that the dose consequences from discharge to the sewer is minimal, and that further limiting concentration or quantity will be unfounded. Should the Commission consider other locations, such as a treatment facility in determining the level ofprotection to be provided? If so, what modeling assumptions would be appropriate? Owing to the uniqueness of every sewage treatment plant, and the differences of every contributor to the system, maybe a retrospective method of regulation should be employed. Perhaps, calculated limits based on point-of-discharge measurements should become secondary, and more emphasis should be placed on the empirical results of the particular situation. One method would be to require licensees to position TLDs at strategic high-potential dose areas at a treatment facility. Licensees might also be encouraged to offer dosimetry and elementary radiation safety training to sewer workers in a cooperative, non-alarming way just as is presently done with local fire and police departments under SARA Title III requirements. The retrospective method would certainly take a lot of the guesswork out the regulating business, and would determine whether or not form or quantity make any difference to the municipal treatment system in question. Further, how would these types of approaches deal with exposure scenarios such as contamination in sewage sludges, as has been the case in contamination incidents. Contamination incidents should be handled in a routine way without "panic attacks", fanfare, or regulatory gesticulation. First of all, the Commission should recognize that sewer lines and treatment systems are in fact contaminated to some degree. With the level of analytical sophistication available today, minuscule amounts of activity can be detected. So what? The sewer system is already a restricted area in the sense that free access is not provided to the general public. Entry into the biologically/chemically hazardous confined space is only allowed to specially-trained individuals, and then only on an increasingly-infrequent basis.

Page 7 of 8 While not trained in radiation safety per se, sewer workers know to employ good hygienic practices and normally do not come in direct contact with the liquid or solid medium. The greatest potential dose problem is from sludge handling, an area that due to other hazards is carefully controlled. The bigger issue in this scenario is what is an acceptable level of contamination that could be expected (permitted?) to exist in the sewerage system or sludge? This harkens back to the need for a "below regulatory concern" policy. Let's face it, this is another case of diminishing returns. It is ridiculous to dig up a rarely-accessed sewer line, or dispose of thousands of cubic feet of dried municipal sludge, so that it can be re-buried at exorbitant cost in a soon-to-be-extinct radioactive waste repository. Doesn't health physics or reason enter into the picture? What about the real health and safety risks that can result from handling sewer-related materials contaminated with an amalgam of human and chemical waste products? This is the kind of twisted rationale that reminds me to try to understand the Commission's dilemma, but also reinforces my fear that political rather than technical solutions will result to fix the "problem". Should the Commission consider limitation using a dose limit approach and provide total quantity and concentration values in a Regulatory Guide to facilitate compliance with the dose limit? I agree that use of a dose limit for compliance would present a realistic approach. It puts the determination on limits back where it should be - based on risk. However, as discussed earlier, the development of such limits would be predicated on a lot of assumptions which must be realistic or else the limits will be as exaggerated as the assumptions. It is presumed that development of quantity and concentration values in a regulatory guide instead of the CFRs indicates that the limits would be guidance but not law. Does this imply that a licensee would have latitude to decide with which method to comply? I am not against a regulatory guide approach. I recommend that the guide provide "tiered" protocol similar to the EP A's NESHAPS compliance method. If a licensee can comply at the lowest level (the most conservative assumptions taken), then the process stops. If not, compliance demonstration can be taken to increasingly higher tiers whereby there is greater emphasis on site-specific data. This method might well be applied to the sewer discharge scenario and could bridge the gap between absolute concentration/quantity/form limits versus case-by-case regulation.

4) Exemption of Patient Excreta The Commission invites comments regarding the appropriateness of continuing the exemption for patient excreta.

As a non-medical licensee, I envy the apparent "double-standard" that the medical community seems to enjoy regarding regulation. Somehow, their radioactive material is "good" and all others is "bad". Even the statement in the Federal Register, "Thus, the doses to individuals

Page 8 of 8 from this source are expected to be far below the NRC's dose limit for members of the public" smacks of favoritism. Is theirs the only eflluent that results in discharges, " ... far below the NRC's dose limit. .. "? I recognize that medical waste is of short half-life, but it is conceivable that concentrations at the treatment works and in sewer systems could result in a measurable equilibrium concentration. Again, the decision to exempt excreta should rest on the resulting downstream dose effect, and not because trace amounts of nuclear medicine radionuclides may be found in the sewer. Does the Commission propose to prohibit discharge of excreta or readily dispersible biological material? Not likely. Better to stay focused on promulgating an equitable dose-related regulatory position, then to take on the medical community. - The issue of disposal to the sewer is complex and without a concrete solution. It is immediately threatening to INS, and in many ways, the entire industry. There are alternative methods to measure and regulate discharge to the sewer. However, we must all take our heads out of the sand and admit that radioactivity does exist in the sewer system, and that it will continue to exist. It is a result of the benefits provided by the uses of products by a variety of industries, including the medical community. Perhaps we should work to raise the level of public acceptance up to the current level of practice, instead of lowering the practice down to the current level of paranoia. In summary, I believe that there can be a workable solution to the discharge issue that may reasonably satisfy the situation without bankrupting the industry. I propose that the Commission put greater emphasis on the actual measurement of resulting sewage treatment plant area exposure rates and sewage sludge concentrations, instead of speculating on the point-of-discharge form, concentration and/or quantity. The empirical measurements can be factored into a dose-based regulation using generally-accepted dose correction factors. If necessary, appropriate measures could then be employed by the licensee to satisfy the established general public dose criterion. I appreciate the opportunity to comment, and hope that my suggestions and observations are used in a mutually-beneficial way. I would like to extend an offer to assist the Commission in any way possible (task force, workshop, forum, etcetera). As part ofINS's proactive position, we have been conducting an array of studies related to the sewer disposal issue. I am willing to share that information where it may be used to supplement the efforts presently being conducted. I can be contacted at the address on the cover sheet. Respectfully submitted, Michael J. Bovino, CHP Manager, Health Physics and Engineering Interstate Nuclear Services Corporation

THE UNIVERSITY OF TEXAS DOCKETED USNRC (z) SOUTHWESTERN MEDICAL CENTER AT DALLAS

                                                                                                                               '94 HAY l 7 PS :oo Frederick J. Bonte, M.D.

Effie and Wofford Cain Distinguished Chair in Diagnostic Imaging Director, Nuclear Medicine Center 8FFIC£ OF SECRETARY DOCKET NUMBEfip ;Lo OCKETING & SERVICE BRANCH PROPOSED RULE..!..!!.....::..----- (Sq f R. q!'16) May 6, 1994 Secretary of the Commission Nuclear Regulatory Commission Attention: Docketing and Service Branch Washington, DC 20555 By way of introduction I am Frederick J. Bonte, M.D., Professor of Radiology at The University of Texas Southwestern Medical School at Dallas, Texas. Presently I serve as a member of the Governor-appointed Texas Radiation Advisory Board, for which body I chair its Medical Committee; I am a member of the Commission on Radiological Units, Standards and Protection of the American College of Radiology; I am a former member of the National Council on Radiation Protection and Measurements. I would like to address the recent requests for public comments on matters involving disposal of radioactive material. The Nuclear Regulatory Commission should not attempt to set limits on the total quantity of radioactive material that can be released annually by a licensee, when that licensee is a large institution such as our own. In our setting there are three major hospitals and a very large research complex, in which a high percentage of laboratories employ radionuclides in basic and clinical investigation. To limit the total quantity handled by such an institution would directly impair its contribution to health care, and to advancement of knowledge about human disease. The same admonition applies to the suggestion that "dose limits" might be applied. When the doses are those used in human diagnosis and treatment the judgement of the physician who is trained in the use of radioactive materials must remain paramount in each individual instance. To interfere with medical decisions is well beyond the province of the Nuclear Regulatory Commission. The final issue involves the "continuation of exemptions for patient excreta". The concept of limiting the amount of radioactive material that a patient could Acknowledged by card ....J_JL ..____-2 1 1 .. Southwestern Medical School 5323 Harry Hines Boulevard/ Dallas, Texas 75235-9061 / (214)648-2025

U.S. Nw 1.. * -.1* \ i t:OM'MISSlON DOCKf:.1,i~1., & SE:fWICE SECTION OFFICE OF THE SECRETARV OF THE COMMISSION Document Statistics Postmar1< Date I LP q --1 Copies Received _ _-;./,---_ _ __ Add'I Copies ReprodU(' ..>d 'b lal Distribution ff/)~ POfl.,

Secretary of the Commission Nuclear Regulatory Commission May 6, 1994 Page 2 excrete is an unfortunate one, since it would involve setting maximum values on the amount of radioactive material that could be administered to a patient with a life-threatening entity such as differentiated thyroid carcinoma. Further, if the Commission were to set some sort of limits on the amount of excreta that could be introduced into the sanitary sewer system, institutions such as our own, which deal with numerous cancer patients, would be placed in an untenable position. We do not now have, nor will we have, facilities in which to store human wastes while radioactive decay takes place. We have always been satisfied that the almost infinite dilution that occurs in the sewer system affords ample protection to the public, and to the environment. Therefore, on behalf of myself, and all my colleagues in the practice of medical treatment and research, I ask the Commission not to attempt to regulate total quantities of radioactive material released by a licensee, nor the individual doses that may be administered to a patient, since to do so might well endanger the public health. Further I ask the Commission to continue exemptions for patient excreta, which I believe are presently being handled in a manner consonant with public safety. Thank you for your attention to these matters. Sincerely yours, Fred *ck J. Bonte, M.D. Cain Distinguished Chair in Diagnostic Imaging Professor of Radiology cit cc: Jose Lopez, Ph.D. Jack S. Krohmer, Ph.D.

UNIVERSITY OF CALIFORNIA, LOS ANGELES UCLA ______________D~D "'"" * "'" * '"'"' * "" <,C<e~ * "~ID, *

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                                           "94 tW< n P-4 :50 UCLA SCHOOL OF MEDICINE May 13, 1994                                                                      HARBOR - UCLA MEDICAL CENTER DEPARTMENT OF RADIOLOGY OFFICE OF s~cRETAA,.Y.,-

ooct:Efl tJ& ~~R\/lv- 1000 CARSON STREET TORRANCE , CALIFORNIA 90509 r Samuel Chilk Secretary, USNRC DOCKET NUMBER Washington, DC 20555 PROPOSED RULE PR 2- 0 (Sq Ff< C/IL/1} Attn: Docketing and Service Branch Re: FR 59 (38), Feb. 25, 1994; pp 9146-9149: RIN 3150-AE90, 10 CFR Part 20: Disposal of Radioactive Material by Release in Sanitary Sewer Systems

Dear Mr. Chilk:

I am surprised and disappointed to see the Advance Notice of Proposed Rulemaking about possible changes in the new 10 CFR Part 20 regarding radionuclide concentrations in sewage. In the first place, the NRC demanded that all states accept the new Part 20 by 1 Jan. 94, quietly threatening to remove Agreement State status if a state was not in compliance by that date. Many states were hoping that NRC would fix the significant scientific problems with Part 20 before considering using it. However, that did not happen. Now, scarcely after the ink is dry, NRC is fiddling with an unimportant portion of Part 20 instead of directing its people to tackle the real problems they created by revising it. In the second place, NRC has failed to show any "problernsi: or "concerns" worthy of corrective efforts in the area of sewage limits for which we will be charged User Fees. The NRC has discovered radioactive atoms in sewage. This is no surprise; we have been using artificial radionuclides since the 1930's. That is why there are limits published in part 20. The significant observation is not that radioactivity is in sewage, but that it is well within the levels set by NRC and is of no safety concern. In the few cases where public concern was expressed (although no hazards existed), the handful of manufacturers and service industries involved made some extra efforts to decrease emissions and all parties were satisfied. The NRC should be delighted that absolutely no need for any further efforts on its part is required. This is a wonderful opportunity to decrease NRC staff and thereby decrease our User Fees. JUL 2 1 1 c1110wl ed Y . . . . . . . MON IIIIJIONCllt Nt .. rt

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May 13, 1994 Samuel Chilk, Secretary Page In the third place, we do not understand why NRC is reviewing the issue of patient excreta after diagnostic and therapeutic nuclear medicine procedures have taken place. There is absolutely no evidence of any hazardous or near-hazardous situation anywhere when such patients produce radioactive excreta which enters ordinary sewer lines, and none has occurred since nuclear medicine began in 1936. What is the point of NRC's "interest", and why should we be asked to waste our valuable professional time producing data that NRC should have had for decades? In fact, these data were finally given to NRC by us on Feb. 14, 1990 when the last American production reactor went down and Richard Cunningham needed to know the total quantity of each reactor-produced radionuclide used by nuclear medicine per year in the United States. From those data, NRC could certainly be expected to derive general sewage levels. NCRP Commentary no. 7, which NRC paid for with our User Fees, tabulated numbers of procedures of different types as of 1989. That certainly should have been good enough for the type of estimate that NRC appears to "require". Why is NRC not using this information? For the record, I am appending data from 1990 and 1992, and adding new data on Sr-89 therapy doses. In the fourth place, the question of saving and decaying out patient excreta is moot. We are not going to save patient excreta. It is preposterously expensive, and medical institutions would simply stop offering nuclear medicine procedures. Licenses will be dropped, User Fee revenue would decrease, a few diehard licensees would not be able to afford the resulting astronomical User Fees and they will end their programs also. NRC would have to end its nuclear medicine program, because it will have ended nuclear medicine for all intents and purposes. However, I somehow think the Congress would stop NRC before patients are jeopardized by lack of services. Just how expensive would it be? Well, let's get some ballpark" estimates for therapy only. This year we will perform about 56,100 nuclear medicine therapy procedures, which includes about 6,000 metastatic surveys for thyroid carcinoma. Of all those procedures only about 6,000 patients need to be hospitalized (thyroid carcinoma therapies), for an average of about two days or a total of 12,000 hospital days. If patients were hospitalized for ten effective halflives, reducing radioactivity to 1/1024 of the original administered activity, the thyroid survey and therapy patients would require 4 days, the hyperthyroid patients would require 43 days, the Sr-89 patients would require 500 days, (T 8 for bone= 2000d; T8 for exchangeable

May 13, 1994 Samuel Chilk, Secretary Page pool~ 28d; Teff for bony Sr=89 = TP) and the P-32 patients (sodium phosphate only) would require 143 days (TB= 257d, so Teff = Tp). That results in a total of 12,000 (4d) + 35,000 (43d) + 8000 (500d) + 550 (143d) = 48,000 + 1,505,000 + 4,000,000 + 78,650 = 5,631, 650 ~ 5.6 million patient days more than we have now. At a cost of about $800/day this comes to $4.5 billion/year. This is for only 56,100 patients, and does not even cover the cost of new plumbing facilities. Each new set of plumbing would cost at least $100,000. How many sets of plumbing would we need? In my 500 bed hospital this year, based on first quarter extrapolation, I will perform 32 thyroid cancer therapies, 12 metastatic thyroid cancer surveys, 72 hyperthyroid therapies, 8 Sr-89 therapies, and no P-32 therapies. That is 44 (4d) + 72 (43d) + 8 (500d) = 176 + 3096 + 4000 ~ 7300 patient days/year for 124 patients. With optimal bed efficiency, I would need a minimum of 1 + 9 + 11 = 21 dedicated sets of plumbing; 30 would be a bare practical minimum because optimization of bed efficiency is not possible with these patients. That comes to $3 million for new plumbing in my hospital alone. And where would we store all this radioactive urine and stool? Each year my hospital would collect about 4,000 gallons of radioactive urine and about 750 gallons of radioactive stool. We have insufficient storage facilities at present, and it would be very costly to build a new one. We have not even begun to discuss diagnostic studies, of which we had 10,700,000 in 1992. Figure that about 45% of these patients are inpatients and 55% are outpatients. Eighty percent of procedures use Tc-99m, and depending on TB, patients could leave at up to 2 1/2 days following administration, say at an average of 2 days. Gallium-67, indium-111, and thallium-201 patients would remain for about a month, and I-123 patients for 5 days, if states were foolish enough to adopt NRC's byproduct regulations for accelerator-produced radiopharmaceuticals. Very roughly, this comes to 78 million patient days at a cost of $62 billion/year. There are about 30 million inpatients a year in the U.S.A.; we would have to add another 4.8 million for excretion collection. Essentially all the hospitals sewage would have to be held for decay. We have not even begun to discuss other contaminated body fluids, such as lacrimal and nasal fluid, saliva, sweat, and blood. NRC had better clear this with President Clinton's healthcare reform people. I think they're going to have a problem with it.

May 13, 1994 Samuel Chilk, Secretary Page In the fifth place, if NRC still isn't satisfied, it could request data from sewage treatment plants in enlightened Agre ement States that have been monitoring for radioactive material for years. Probably many of those "inadequate and incompatible" states have had the foresight to collect the data that NRC lacks; certainly California and New York do so. Then, when the expected GAO "expose" is released, NRC could actually answer the GAO with valid scientific data instead of shrugs. In the sixth place, I don't think NRC should do anything with the sewer standards because EPA will probably do it when it gets around to it, and of course override NRC. Why should we pay any User Fees to NRC at all for this when we are already paying taxes to support EPA, and will have to live with EPA's standards anyway? In conclusion, I would suggest that before NRC litters the Federal Register with any more nuclear nonsense impacting its already severely dysfunctional "medical" program, that it review the material first with its Advisory Committee on Medical Uses of Isotopes. Thank you for the opportunity to comment on this Advance Notice of Proposed Rulemaking. Sincerely,

 ~

Carols. Marcus, Ph.D., M.D. Director, Nuclear Med. outpt. Clinic and Assoc. Prof. of Radiological Sciences UCLA and Member, USNRC Advisory Committee on Medical Uses of Isotopes and Chair, USFDA Advisory Panel on Radiologic Devices and Vice-President-Elect, Society of Nuclear Medicine cc: Interested parties CSM:sfd fr59chil.csm

NUCLEAR MEDICINE THERAPY PROCEDURE ESTIMATES, 1993 P-32: 1100/yr. For purposes of calculations in these comments I assumed that half were P-32-sodium phosphate and half were P chromic phosphate. I-131-sodium iodide: 6000 thyroid cancer ablations, 6000 metastatic surveys, and 35,000 hyperthyroid therapies. ( The total quantity of I-131 used in nuclear medicine in the United States each year is about 1 kilocurie.) - Sr-89-chloride: 8000/yr and rising to about 10,000-11,000/yr. frS9chil.csm

TOTAL PROCEDURE VOLUMES OSPITALS & NON-HOSPITALS, 1990 & 1992 10--,------------------_.:;---------- Lege,d

 ~  Hospifal fl Non*H* spital 1989              1990        1991             1992 Total 1989 Tota] 1990   Total 1991      Total 1992 8,800,000        9,90C,000   10,100,000      1*),700,000

         . ..:J * ~     ESTirvIATES OF ANNUAL U.S. NUCLEAR IMAGING PROCEDURE VOLUME l

• 1988
• 199'2 ( !OOO'S) l Procedure Category [ 1988* 1989* . 1990 1992

                  .j   HOSPITALS Bone           .......                  2,231              2,377       3,464    3.457
       .f              Brain                                      68                 94         120       100 Cardiovascular               --~ ---~,062                  2,288      2,539     3,232
   .I            1 Liver Renal/Hepatobiliarv RespiratO!}'.

Monoclonal 446 667 1,223 0 412 754 1,170 0 474 810 1,085 0 346 845 998 20 I Othf:T Total 1.059

                                                             . 7.756 1.147 8.242
                                                                                        -       607 9,099 741 9,739
   ~
                                                    ~

INDEPENDENTS Bone 332 387

              *.!      Brain                                                                      9         4 i        Cardiovascular Llver Renal/Hepatobiliary 338 41 40 488 35 37 Resoitatorv
                       ?vfonoclonal 19 0

17 1 Other 60 61 Total 423** 596u 839 1,030 GRAND TOTAL Bone 3,796 3,844 Brain 129 104 Cardiovascular 2,877 3,720 Liver 515 381

     ,  ... .                                        --                                        850       882

... **.'*~- Renal/Heoatobiliarv . 1,104 1,015 Respirat_2ry

                                              - ......                                            0       21 Monoclonal             -              -                                 661       802 Other
                                    ----- -                                                  9,938    10,769 Total                               ~._179*

• 8,838°
• Based on sampling of 350 + sites in studv conducted for NBMA/SNM

                     **     Independent data by procedure categori is not available for 1988 and 1989 IV-5

COMMITTEE TO BRIDGE THE GAP 1637 BUTLER AVENUE, SUITE 203 LOS ANGELES, CALIFORNIA 90025

                                                                                                      -OOCKETEO USNRC (f)-

l::1/ (310) 478-0829

                                                                                                   *94 HAY -5 P7 :13 DOCKET NUMBER PROPOSED RULE Pl. ~V _-
                                                                            /J .   .          OFFlci6~kbWrARY DOCKETING & SERVICE
                                                                                              ._       BRANCH (S~FRq111{y                .

Attention: Docketing and Seivice Branch, Secretary of the Commission U.S. Nuclear Regulatory Commission Washington, D.C. 20555

DearNRC:

                  . I am interested in submitting comments on potential modifications to the regulations g_overning disposal of radioactive materials into sanitary sewer systems (10 C.F.R. Part 20).

To do so, I would like to obtain a copy of the petition for rulemaking submitted by the Northeast Ohio Regional Sewer District in Cleveland, Ohio. I would also like to obtain a copy of the initial NRC contractor report evaluating past cases of sewer _system disposal of radioactive materials.

• Thank you for your assistance and cooperation.

                                                             ~smZ<,<~
                                                              ~e~h K. Lyou, Ph.D.

Executive Director (i) l00% P~,1-Co~sumer Waste Recycled /'aper AcknOMedged by card.~.~~~****

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bOCKET NUMBER PROPOSED RULE p A0 Image America Th, 011rpntient Company ( St!f FR ql'-16) DOCKETED USNRC

                                               '94 MAY -2 P4:11 May 2, 1994                                                                              ImageAmerica 109 Westpark Drive
                                      . . OFFICE OF SECREiARY                                    Suite 420 The Secretary of the Comm1ss10I{)QCKET ING & SERVICE                            Brentwood, TN 37027 U.S. Nuclear Regulatory Commission BRANCH                                               615 373 5400 I*  Washington, DC 20555                                                                FAX 615 373 3093 Attention:        Docketing and Service Branch

Dear Secretary:

I write to comment during the Commission's advance notice of proposed rule-making concerning the Disposal of Radioactive Material by Release into Sanitary Sewer Systems as published in the federal Register, volume 59, number 39, February 25, 1994; i0 CFR Part 20, RIN 3150,AE90. I would like to restrict my comments to Section 4 of the Request for Information and Comment, specifically regarding the Exemption of Patient Excreta for those individuals undergoing nuclear medicine diagnosis and treatment. ImageAmerica is a clinical provider of healthcare services to include nuclear medicine diagnostic and therapeutic procedures direct to referred patients in both inpatient and outpatient settings. lmageAmerica operates in compliance with applicable federal and state regulations regarding its nuclear medicine activities. Consequently, its activities would be subject to any modifications of the current Exemption of Patient Excreta from regulation regarding Disposal of Radioactive Material by Release into Sanitary Sewer Systems. lmageAmerica supports the continuation and reaffirmation of the Exemption for Patient Excreta in its current form for the following reasons:

1. By its own rationale, "The Commission currently believes the present regulation is adequate ... " and recognizes that the current Exemption does not create any public hazard. 1 lmageAmerica takes the posi(ion that any modification of die curreut Exemption would have no demonstrable benefit regarding public health.

   ' NRC - Disposal of Radioactive Material by Release into Sanitary Sewer Systems, 10 CFR Part ::'.O, Federal Register, vol. 59, no. 38, page 9148.

Acknowledged by card ....MAY__ 1 o_ 199C_

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2. The cost of compliance to additional standards would be significant in the event the Exemption is removed. Each licensee would incur the minimal compliance expense of retaining professional assistance to determine the operational requirements necessary to comply with any additional rule-making. Enforcement of the additional rule-making would be assessed against licensees as increased license fees, inspection fees, or against the public as increased governmental expense. ImageAmerica takes the position that its additional cost of compliance would result in an increase to fees charged patients for procedures performed. This is contrary to governmental efforts to control the rise of healthcare costs. Consequently, any modification of the current Exemption is contrary to current governmental policy initiatives.

3. Should the Exemption be removed, and rule-making requires control of human waste, the likely methodology used will require the collection and storage of human waste for decay prior to disposal. lmageAmerica believes this will result in a significantly increased radiation exposure burden to the healthcare workers responsible for the patient undergoing the nuclear medicine procedure, and significantly increase the number of healthcare workers exposed to such radiation.

Consequently, any modification of the current Exemption is contrary to efforts to minimize the radiation exposure to the general population at large.

4. Should the Exemption be removed, and rule-making requires control of human waste, the likely methodology used will require the collection and storage of human waste for decay prior to disposal. lmageAmerica believes this will result in a significantly increased radiation exposure burden to the patient undergoing the procedure given the storage and handling requirements for procedures normally perfom1ed in the outpatient setting. In addition, ImageAmerica believes this will result in a significantly increased radiation exposure burden to the patient's family, to include unnecessary exposure to small children and pregnant individuals in the home setting. Consequently, any modification of the current Exemption is contrary to efforts to minimize the radiation exposure to the general population at large.

5. Should the Exemption be removed, and rule-making requires control of human waste, the likely methodology used will require the collection and storage of human waste for decay prior to disposal. ImageAmerica believes that patient compliance will be difficult to achieve in the out-patient setting, and environmental contamination due to spillage will be much more likely. ImageAmerica believes this will result in a significantly increased radiation exposure burden to the patient's family, to include unnecessary exposure to small children and pregnant individuals in the home setting, and unnecessary risk to the general public. Consequently, any modification of the current Exemption is contrary to efforts to minimize the radiation exposure to the general population at large.

2

6. Should the Exemption be removed, and rule-making requires control of human waste, the likely methodology used will require the collection and storage of human waste for decay prior to disposal. Should rule-making restrict the collection and storage of human waste to an in-patient setting, this will require the patient receiving nuclear medicine procedures to undergo them with follow-up in an in-patient setting. The incremental cost to the patient for the procedure to be performed in this in-patient setting would be significantly higher than that currently seen for the same procedure as an outpatient. lmageAmerica believes that removal of this Exemption will result in increased healthcare costs, which is contrary to governmental efforts to control the rise of healthcare costs. Consequently, any modification of the current Exemption is contrary to current governmental policy initiatives.

7. Should the Exemption be removed, and additional controls placed on the provider, patient, or licensee performing the procedure, lmageAmerica believes that this will constitute an additional restriction to access to the clinical benefits inherent in performing the nuclear medicine procedure. Given that most nuclear medicine procedures are inherently sensitive to the pathology for which they are used to diagnose, given that there are no reasonable alternatives to most common nuclear medicine procedures, and given that other alternatives involve greater radiation exposure, patient morbidity, and mortality, lmageAmerica believes that modification of the current Exemption will result in a significant compromise to Quality of Care.

8. Should the Exemption be removed, and rule-making requires control of human waste, the likely methodology used will require the collection and storage of human waste for decay prior to disposal. ImageAmerica believes there is a significantly increased likelihood that the patient will decline a procedure required by the patient's clinical presentation given the aesthetic issues involved in the collection and storage procedure required. The result is a clear compromise to the patient's Quality of Care.

For these reasons, ImageAmerica requests that the Nuclear Regulatory Commission reaffirm the inherent public health benefit of the current Exemption of Patient Excreta, and defer permanently any initiative to modify or eliminate that Exemption. Thank you for the opportunity to comment on this issue. Sincerely, Ted Bennett Director of Operational Resources 3

DOCKET NUMBER PR 2:e!J.-,_ DOCKETfD US*4RC 0

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l. 'f: t W1J\ of o' The Na~ 1/4$rne of the lmmac!iate Conce-ption, Washington, D.C. The tribute of American Catholics to Our Blessed Mother as Patroness of the country, the shrine is the largest Catholic church In the United States . The Knights Tower Is 329 feet high; the Dome 239 feet high and 109 feet In diameter. The architecture Is con-temporary, but In the spirit or Romanesque and Byzantine.

104 Photo by Dino Sass! KINA, MIiin , Italy MAY 1 0 1994 Acknowledged by card w*:ccss:wee:e:w:o:mxwe

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o~g~6l~ou~~~: PR ;z rJ (S1FR Cf /L/0 DOCKETED 1705 David Court USNRC Ann Arbor, Michigan 48105 March 30, 1994 OFFICE OF SECRETARY DOCKETING & SERVICE The Secretary of the Commission BRANCH US. Nuclear Regulatory Commission Washington, DC 20555

Dear Sir or Madam:

I am sending comments regarding RIN 3150-AE90 which appeared in Federal Register Vol. 59 No. 38 Friday, February 25, 1994 pages 9146 to 9149. I do not believe that NRC used a reasonable basis for excluding insoluble sewer releases. For example, how is solubility defined? Any solution will precipitate when present in sufficiently high concentrations (such as at a waste water treatment plant). I believe that the regulatory limits which govern the release of radioactive material should be based entirely on the expected radiation dose equivalent to the public. "Insolubllradioactive materials will tend to 1 accumulate at waste water treatment plants along with other 11 ' insoluble non radioactive materials such as heavy metals. Sludges from a waste water treatment plant are currently handled with care since they present pathogenic and chemical toxicity risks. This process of trapping pollutants is precisely how a good waste water treatment plant should work. I sense that detection of radioactive materials at a waste water treatment plant is somewhat of a public relations problem for NRC since its rules allowed detectable releases. I do not believe that rules should be based on detectability, a perception of the public opinion, or on convenience to the Commission. A sufficiently sophisticated radiation detection system could detect even low level "soluble" releases. Furthermore, detection limits are likely to improve over time. This makes basing a limit on detection a moving target. Secondly, public opinion is difficult to measure and bound to change. Finally, convenience to itself is a self serving and unreasonable process. Ultimately, NRC is a servant of the public. I think that NRC should base these release concentrations on modeling which uses the Federal Radiation Council MAY 1 0 1994, Acknowledged by card ............................ ~..

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dose limits. This modeling should be reasonable without reliance on unnecessary conservatism for unusual scenarios. I support the exemption for patient excreta based on my belief that this reduces medical care costs and improve care. US Medical care costs are already the highest in the world. This exemption permits interaction with the patients family. This interaction has enormous benefits to the patients happiness which can speed recovery. Secondly, this allows the patient to return more quickly to employment which may be essential to their well being. Thirdly, patients are extremely difficult to control and this would create virtually insurmountable challenges to licensees. This could result in hospitals avoiding providing nuclear medicine care since it entails legal risks. Finally, extremely strict controls over patients could infringe upon a patient's constitutional rights. I think that NRC should grant exemptions to waste water treatment plants for material released into their systems. Otherwise, this would result in enormous costs with little possible benefit. Sincerely, Alan M. Jackson Health Physicist

March 17, 1994 DOCKETED USHRC (j)

                                                      "94 MAR 22 P3 :14 TO : Secretary of the Commission u.s. Nuclear Regulatory Commission Washington DG 20555                           OFFICE OF SECRETARY         E ATTN: Doceting and Service Branch            OOCKETI HG & SERVIC BRANCH FROM : Nat Hendricks, PO Box 738 , Main Street , Putne7 V~ 05346 Tel : 802-387-5232 RE : Comments on Nuclear Regulatory Commission 10 CFR Part 20 RIN 3150-AE90 I wish to make the following comments on the Nuelear Regulatory Commission 10 CFR Part 20 , Disposal of Ra~ioactive Material by Release into Sanitary Sewer Systems .

l . ) Sewage sludge is handled in many different ways:: some is landfilled , some is spread on farmers fields, some is stored for later disposal , and some is made into a compost for sale to the public*.

2. ) Generacially sewage sludge from areas where workers exposed to radio nuclei flakes in their occupations may take the radioactivity into their residences ,

dwelling units and finall.y into the sewage sludge should be tested on a regular basis .

3. ) Specifically the open air surface impoundment of sewage sludge of the Town of Putney , Vermont, the ~o-called reed bed:" should be tested: on a regular basis for radioactivity . Many of the workers at the Vermont Yankee Atomic Plant in Vernon , VT reside in the Putney Area . Radioactive particles from the Vermont Yankee have been detected in the sewage sludge from the plant spread on area farm fields , the local sew.age treatment pl.ant and in a pit .

4 . ) The pr&pased rulemaking should be stricter and more limiting on the release of radioactive materials into sanitary sewers . Thank you. I MAY 1 o 19941 Acknowledged by card ...--."............:-;

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                                                               *94 FEB 22 "' ** :~1 NUCLEAR REGULATORY COMMISSION 10 CFR Part 20 RIN 3150-AE90 Disposal of Radioactive Material by Release into Sanitary Sewer Systems AGENCY:    Nuclear Regulatory Co11111ission.

ACTION: Advance notice of proposed rulemaking.

SUMMARY

The Nuclear Regulatory Co11111ission (NRC} is seeking information to determine whether an amendment to its regulations governing the release of radionuclides from licensed nuclear facilities to sanitary sewer systems is needed. The potential rulemaking would revise the approach to limiting the release of radioactive materials into sanitary sewer systems by licensed nuclear facilities based on current sewer treatment technologies. This advance notice of proposed rulemaking is being issued to invite co11111ents, information, and reco11111endations from interested parties on the issues that have been identified as candidates for consideration as part of this rulemaking.

S /1._6 /1L/ DATES: The co11111ent period expires {90 days after publication in the Federal Register}. Co11111ents received after this date will be considered if it is practical to do so, but the Co11111ission is able to assure consideration only for co11111ents received on or before this date.

r ADDRESSES: Hail co11111ents to: 'The Secretary of the Co11111ission, U.S. Nuclear Regulatory Co11111ission, Washington,*DC 20555, Attention: Docketing and Service Branch. Deliver co11111ents to: 11555 Rockville Pike, Rockville, Maryland, between 7:45 a.m. and 4:15 p.m. Federal workdays. Examine copies of co11111ents received at: The NRC Public Document Room, 2120 L Street NW. (Lower Level), Washington, DC. Copies of NUREG/CR-5814, which supports this advance notice, may be purchased from the Superintendent of Documents, U.S. Government Printing Office, P.O. Box 37082, Washington, DC 20013-7082. Copies are also available from the National Technical Information Service, 5285 Port Royal Road, Springfield, VA 22161. A copy is also available for inspection and/or copying, for a fee, at the NRC Public Document Room, 2120 L Street, NW. (Lower Level), Washington, DC. FOR FURTHER INFORMATION CONTACT: Dr. George E. Powers, Office of Nuclear Regulatory Research, U.S. Nuclear Regulatory Co11111ission, Washington, DC 20555, telephone (301) 492-3747. SUPPLEMENTARY INFORMATION:

Background

The Nuclear Regulatory Co11111ission regulates the release of radioactive material by licensees into sanitary sewer systems under 10 CFR Part 20. The basis for the NRC's sewer release requirements was established over 35 years 2

ago. The NRC and Agreement States have become aware of instances where radioactive material has been detected in sewage treatment systems. Examination of several of these cases led the Commission to modify the requirements for disposal of radioactive materials into sanitary sewers as part of the revised standards for protection against radiation added to 10 CFR Part 20 (56 FR 23360; May 21, 1991). In particular, the Commission removed the provision (except for the case of biologically dispersible materials) which allowed the disposal of dispersible materials into sewers because it appeared that dispersible, but insoluble materials, were generally implicated in the sewer sludge contamination cases. In addition, the concentrations allowed for various radionuclides released to sewers were reduced by a factor of 10, as part of an overall reduction in effluent release limits. The concentrations listed in Table 3 of Appendix B to 10 CFR Part 20 were calculated on the basis of a 5 mSv {500 mrem) dose via ingestion of material at the discharge point from the licensee. The concentrations listed in Table 3 were considered reasonable since it is unlikely that any individual would actually consume water at the point of discharge and since dilution from additional contributions within the sanitary sewer would likely reduce levels to well below the 1 mSv {100 mrem) annual dose limit for members of the public. The provisions permitting the release of soluble material and the total quantities of material which could be released in any one year were retained in the revision to 10 CFR Part 20. These provisions have been effective since June 1991. However, licensees have until January I, 1994, to comply with the requirements. In promulgating the revised standards for protection against radiation, the NRC acknowledged that additional information was necessary regarding potential 3

pathways of exposure and radiation doses that could result from releases into sanitary sewers, particularly in light of new sewerage treatment systems that further concentrate solids and are used by large municipalities. The NRC is publishing this advance notice to obtain public c011111ent on a number of issues associated with the release of radioactive material to sewer systems. This information will be used in evaluating what additional changes to the requirements in 10 CFR Part 20 may be necessary. This information will also be used in assessing the impacts of the various options that may be available for imposing any necessary additional requirements. Discussion There are approximately 15,000 sewer treatment plants {STPs) in the United States and 23,000 specifically licensed users of radioactive materials. It is not uncommon for several licensed radioactive materials users to discharge radioactive waste materials into the same sewerage system. Sewage treatment plants {STP) vary in size {capacity) from less than 1 million gallons per day {gpd) to over 1 billion gpd. A capacity of I million gpd would serve about 5000 people and a few small connercial users. A I billion gpd facility would accommodate a population of about 5 million people and a substantial industrial base. The sewage treatment process, the size of the sewage treatment facility, and the amount, as well as the physical and chemical form, of the radioactive materials released to the sewer system can have a significant effect on the fate of the radioactive materials in the process and the final concentrations of materials in the sewer sludge or ash. 4

A number of incidents of radioactive material contamination and reconcentration have occurred. A description of some of these cases is included at the end of this notice. It should be noted that each of these cases occurred prior to implementation of the revised Part 20 limits for releases of radioactive material to sewer systems. In 1989, the NRC contracted with Battelle, Pacific Northwest Laboratories, (PNL) to study situations where radioactivity has been reported in sewer systems or sewer treatment sludge. The results of the PNL study were published in Hay 1992 as NUREG/CR-5814, "Evaluation of Exposure Pathways to Han from Disposal of Radioactive Materials Into Sanitary Sewer Systems." NUREG/CR-5814 includes information on sewage treatment and disposal practices,

• and exposure pathways and scenario analysis, based on case studies of situations where radioactive contamination has been reported in sewer systems or in s~wer treatment sludges.

The PNL study performed theoretical modeling of most types of licensee radioactive discharges, except for excreta from individuals undergoing medical diagnostic or therapeutic administrations of radioactive material, which are exempt from regulation under§ 20.2003. Modeling scenarios estimated the exposure to individuals at the sewer treatment facility and as a result of various uses of sewage sludges resulting from treatment. The results of the study predicted doses of 0.2 to 93 mrem/yr total effective dose equivalent (TEDE). The assumptions used in the study were that all material was released at the Part 20 limit and subsequently reconcentrated. Thus, the doses calculated represent an upper bound of possible doses to actual individuals. 5

Request for Information and C011111ent The Co11111ission requests co11111ents and infonnation on a number of issues related to requirements for disposal of radioactive material into sanitary sewers. This request for co11111ents and information is in the context of evaluating the options which may be available to the Co11111ission to provide additional or alternative means of regulatory control over releases into sanitary sewers. The convnents and information which will be particularly useful are those related to the impacts of various alternatives for each issue, including impacts on various types of licensees such as biomedical and university research licensees. (1) Form of the material for disposal. The standards for protection against radiation in 10 CFR Part 20 permit the disposal of materials into the sanitary sewer if they are soluble or readily dispersible biological materials. Formerly, the release of dispersible non-biological material was permitted. At the time of publication of the 1986 proposed rule (51 FR 1092; January 9, 1986) for the revised standards for protection against radiation, the Convnission had proposed that only soluble materials be permitted for disposal into sanitary sewers. The Commission received significant co11111ent at that time regarding the practice of research institutions to use sewer disposal as the preferred alternative for disposal of tissue samples over incineration. As a result, the May 21, 1991, final rule allows readily dispersible biological material to be released but prohibits the release of any non-biological insoluble material. 6

The Comission recognizes that new technologies for sewer treatment are currently under development, such as the emerging mesocosm-based treatments which use bioprocessors to neutralize sludge. These bioprocessors can be selected with unique abilities to selectively reconcentrate specific heavy metals and organics. In the consideration of new requirements, the Conmission invites coments on to what extent and how the regulations should take into account the technologies for processing sewage including technologies such as bioprocessing or ion-exchange. Coincident with publication of this advance notice, the Co11111ission has initiated contract support to analyze typical water treatment processes, which includes determining how the solubility of materials in influent to a treatment plant may be changed in a way that affects the potential dose to members of the public. One possible outcome of this analysis could result in modified restrictions regard~ng the forms of materials suitable for disposal. Comments on the potential impacts on licensee's operations associated with any additional restrictions regarding the forms of materials suitable for dispersal are solicited. (2) Total Quantity of Material. In the Hay 21, 1991, final rule, the Comission did not change the total quantity of radioactive materials which could be released into sanitary 14 sewers. In brief, the limits are 185 GBq (5 Ci) of 3 H, 37 GBq (1 Ci) of C, and 37 GBq {l Ci) of all other radioactive materials combined to be released into a sanitary sewer by a licensed nuclear facility in a year provided the licensee complies with the other requirements of 10 CFR 20.2003. The use of a total quantity limit has been a long-standing requirement and was originally 7

included to address concerns regarding the possibility for reconcentration. The Co11111ission solicits co11111ents regarding the acceptability of this approach, and whether a total quantity to be released should be specified or otherwise limited. As an alternative, the Co11111ission solicits conments on an approach which might limit the total quantity of each radionuclide, sue!; as some multiple of the annual limit of intake values or the related exempt quantities published in 10 CFR Part 30. This alternative approach could have the advantage of specifying a total quantity limit, concentration and form e requirement based upon the biokinetics and health risk for each radionuclide. In particular, the Commission solicits co11111ents on the potential impacts on licensee's operations associated with further restrictions on the total quantity of radioactive material which could be released during a year. The Co11111ission also invites comments on whether the total quantity of radionuclides that may be released to a sanitary sewer by a licensed nuclear facility should take into consideration the capacity and treatment methods used by the water treatment plant that serves the licensee, and whether consideration should be given to the fact that many licensed facilities may discharge into the same sewer treatment plant. In this regard, the Co11111ission is interested in comments on the practicality of these approaches. The NRC has also received a petition for rulemaking submitted by the Northeast Ohio Regional Sewer District concerning the disposal of radioactive material into sanitary sewerage (PRM-20-22). A notice of receipt and request for comment on the petition was published in the Federal Register on October 20, 1993 (58 FR 54071). The petitioner requests that the NRC amend its regulations to require that all licensees provide at least 24 hours advance notice to the appropriate sewage treatment plant before releasing radioactive 8

material to the sanitary sewage system. The petitioner also requests that the NRC exempt materials that enter the sanitary waste stream from the requirements regarding Conwnission approval for incineration under the NRC's current regulations. Conwnents on the issues raised in this petition will be considered in any possible revision to NRC regulations. (3) Type of Limits. The present method of limiting releases into sanitary sewers is to e specify annual total quantity and concentration values of radioactive materials. Table 3, Appendix B, of revised 10 CFR Part 20 lists the concentrations of radioactive materials which can be disposed of in sanitary sewers and is based upon a calculated dose of 5 mSv/yr (500 mrem/yr) via ingestion of the effluent as the total water intake of the individual (2 liters/day} at the point of release. These limit~ are based upon a model of exposure which assumes that an individual could be present at the sewer outfall of the licensee, and that the exposure pathway is the ingestion of water. The Convnission invites comments on two facets related to this regulatory approach. First, should the Co11111ission continue an approach of limitation based upon an individual being exposed by the ingestion of water from the sewer outfall? Alternatively, should the Co11111ission consider other locations, such as at a treatment facility, in determining the level of protection to be provided? If so, what modeling assumptions would be appropriate? Further, how would these types of approaches deal with exposure scenarios such as contamination in sewage sludges, as has been the case in contamination incidents? 9

Second, should the Comission consider limitation using a dose limit approach, and provide total quantity and concentration values in a Regulatory Guide to facilitate compliance with the dose limit? (4) Exemption of Patient Excreta. The present requirements exclude from sewer release limits the contribution of patient excreta which may contain radioactive materials as a result of nuclear medicine diagnosis or treatment. In general, the radioactive materials used in these types of procedures have short half-lives and decay rapidly after their production, use and subsequent release into the sanitary sewer. Thus, doses to individuals from this source are expected to be far below the NRC's dose limit for members of the public. The Comission currently believes that the present regulation is adequate but recognizes that radionuclides used in nuclear medicine have been detected in very low concentrations on occasion at treatment facilities. Therefore, the Comission invites comments regarding the appropriateness of continuing the exemption for patient excreta. The preliminary views expressed in this notice may change in light of cements received. In any case, there will be an opportunity later for additional public comment in connection with any proposed rule that may be developed by the Commission.

Case Studies Case 1 - Tonawanda, New York. A manufacturer of smoke detectors, which used Americium-241 (241Am) foils, operated in the 1970s and early 1980s in Tonawanda, New York. When the 2 1 facility was being decoD111issioned in 1983, ' Am contamination of the sewer lines leading from the facility was detected. Similar contamination was subsequently detected in the STP sewage sludge and incinerated sludge ash residue. It is believed that the contamination occurred over a period of several years. Tests performed by the State of New York in 1984 showed levels 241 up to 27.75 Bq/g (750 pCi/g) of Am in ash _taken from a sludge incinerator. Levels of 5.92 Bq/g {160 pCi/g) were detected in landfill samples. The levels in the sludge at the time of the investigation were up to 3.7 Bq/g {100 pCi/g). Following the termination of licensed activities in 1983, these levels decreased to less than .037 Bq/g (1 pCi/g) by 1986. Bioassays of STP workers and landfill workers detected no radioactivity over background levels in their lungs or bones. Case 2 - Grand Island, New York. 241 Because of the Am contamination at the Tonawanda STP, the New York Department of Health also collected sludge samples in 1984 at the Grand Island STP, which received effluent from another manufacturer that produced devices that used 3 H, 210 Po, and 241 Am. This manufacturing facility discharged about 2 1 0.925 MBq/yr (25mCi/yr) of ' Am into the sanitary sewer that fed into the Grand Island STP. The Grand Island STP uses tertiary treatment prior to discharging effluent, with a sludge production averaging 450 ton/yr. Tertiary treatment removes material from the effluent that has not been removed through 11

primary and secondary treatment. Tertiary treatment may include the use of microscreens, filtration through specific media such as activated charcoal, precipitation, and coagulation prior to discharging effluent. The sludge is digested and pressed to increase the solids content to about 20i, and it is 241 subsequently buried in a landfill. The average Am concentration in the dry sludge was about 3.7 Bq/g (100 pCi/g) dry weight when first studied. At the request of the New York State Department of Labor, the manufacturer reduced 2 1 the ' Am concentration in its liquid discharges after the contamination was identified. By adding filtration to the licensee's ~olding tank, 2 1 concentrations of ' Am in sludge were decreased to about 1.48 Bq/g (40 pCi/g). Using information provided by the State of New York, calculations of the 2 1 annual average concentration of ' Am in the wet sludge were based on the 2 1 assumption that all ' Am entering the plant was concentrated in the sludge. 241 Wipe samples taken within the STP did not detect Am above levels allowed for unrestricted use (20 dpm/lOOcm2 removable alpha contamination and 100 dpm/lOOcm2 total removable and fixed alpha contamination). Some of the workers used dried sludge as a soil supplement in their home gardens, and one 2 1 garden showed measurable amounts of ' Am. Based on the sampling data, it was concluded that there did not appear to be a radiation hazard to the STP employees or landfill employees and that no specific safety measures beyond those normally taken by employees would be required of these facilities. Case 3 - Royersford, Pennsylvania. A co11111ercial laundry for radioactively contaminated protective clothing discharged approximately 15,000 gallons of wastewater per day to the local sanitary sewer system. The wastewater from the laundry was temporarily stored, treated to adjust the pH, and analyzed for gross alpha and gross beta 12

activity before the contents were released to the sanitary sewer system. Inspections by the NRC in late 1985 revealed no violations by the licensee. Subsequently, an inspection of the Royersford STP revealed radiation levels up to 12 pSv/h (1.2 mR/h) above background at the secondary digester. Because of these elevated levels, the NRC evaluated the impacts of the radionuclides released to the sanitary sewer system by the laundry facility. The evaluation encompassed not only the STP, but the potential radiological impact of sludge applications to agricultural areas as well. The results indicated that the highest potential doses would be received by farmers working the fields where the sludge had been applied. However, potential doses were less than 50 pSv/yr (5 mrem/yr). Radiation levels on the outside of a tank truck, used to carry the sludge to application sites, ranged up to 3 pSv/h (0.3 mR/h), well within the range allowed for transport by the Department of Transportation. Case 4 - Oak Ridge, Tennessee. A company in Oak Ridge which specialized in decontaminating nuclear power plant materials disposed of a small amount of radioactive material by release to the city sanitary sewer system. When a new STP was put into operation by the city of Oak Ridge, contamination of the sewer lines leading from the company was discovered. In addition, radionuclides were detected in the sludge being processed at the sewage treatment facility. The contamination was found at the STP in both its primary and secondary digesters. This sludge had subsequently been applied to deforested land at a government facility, resulting in radiation levels of about 0.1 pSv/h (0.01 mR/h) (2 to 3 times background) in the area. Stricter radioactive material release guidelines were set by Tennessee's Division of Radiological Health, to limit the amount of radioactive material released to the sewer system. 13

Additionally, the licensee was allowed to release only soluble material, because it was suspected that some of the material previously released had been insoluble. A study was conducted by the State of Tennessee to evaluate the risk to the general public from the radionuclides released into the sanitary sewer systems at Oak Ridge and Erwin, Tennessee. The study estimated that there 137 were four radionuclides of concern in the sludge, of which Cs was the primary contaminant, with lesser quantities of 6 °Co, 134 Cs and ~n. It was determined that the primary risk would be through consumption of vegetables grown in a garden fertilized with sludge from the STP at an estimated dose rate of approximately 60 µSv/yr (6 mrem/yr). Case 5 - Washington, D.C. The Blue Plains Wastewater Treatment Plant processes waste from the metropolitan Washington area, including a number of Federal research facilities that use a relatively broad spectrum of radionuclides. Some liquid effluents are released directly to the sanitary sewer system, while others are e retained in temporary holding tanks to permit decay of short-lived isotopes before release. Inspections of two research facilities and the STP were conducted in early 1986, with no violations of Federal regulations or licenses noted. Samples were obtained at both facilities from holding tanks and effluent discharge points and at the STP for influent, liquid effluent, and sludge. Radionuclide concentrations in facility effluents were 2% or less of the limits specified for maximum daily release concentrations in Appendix B, Table I, Column 2 of the version of 10 CFR Part 20 in effect at that time. Analysis of the STP samples revealed that concentrations of soluble isotopes, 137 such as Cs and beta-emitters in general, were on the same order of magnitude 14

for liquid influent and effluent, and that concentrations in sludge were about 10% of those in the liquid samples. In contrast, for insoluble materials (primarily alpha-emitters), the influent concentrations were about 10 times higher than those of the liquid effluent samples. Since the publication of the NUREG/CR-5814, additional incidents concerning the reconcentration of radioactive isotopes in sewerage sludge have been identified, and one is presented below. Case 6 - Cleveland, Ohio. During an aerial monitoring survey of an NRC licensee in the Cleveland metropolitan area, 6°Co contamination was identified in a STP that is part of the Northeast Ohio Regional Sewer District(NEORSD) and services a large portion of Cuyahoga County. The source of the radioactivity may have originated from a sealed source manufacturer which had previously discharged to the STP. Analysis of treated sewerage sludges samples revealed 6°Co concentration averages from approximately 2.96 to 14.8 Bq/g (80 to 400 pCi/g). The STP is currently proceeding to remediate the site. In October 1993, the NRC has received two Requests for Modification of a License under 10 CFR 2.206 from NEORSD. The first 2.206 Petition, notice of receipt published in the Federal Register on April 13, 1993 (58 FR 19282), requested modification to a license to require the licensee 1) to assume all costs resulting from the off-site release of cobalt-60 that had been deposited at a District treatment plant, and 2) to decontaminate the sewer line connecting the licensee's facility and the District's treatment plant. The second 2.206 Petition, notice of receipt published in the Federal Register on December 6, 1993; 58 FR 64341, requested modification to a license to require that the 15

licensee provide adequate financial assurance to cover public liability pursuant to section 170 of the Atomic Energy Act of 1954, as amended, 42 U.S.C. § 2210. The NRC is taking appropriate action on the two 2.206 Petitions as separate matters. List of Subjects in 10 CFR Part 20 Byproduct material, Criminal penalties, Licensed material, Nuclear materials, Nuclear power plants and reactors, Occupational safety and health, Packaging and containers, Radiation protection, Reporting and recordkeeping requirements, Special nuclear material, Source material, Waste treatment and disposal. The authority citation for this document is: Sec. 161, 58 Stat. 948, as amended (42 U.S.C. 2201); Sec. 201, 88 Stat. 1242, as amended (42 U.S.C. 5841).

                                             ~

Dated at Rockville, Maryland, this /5. day of February, 1994. ission. 16}}