This section of the FEDERAL REGISTER

contains notices to the public of the proposed

issuance of rules and regulations. The

purpose of these notices is to give interested

persons an opportunity to participate in the

rule making prior to the adoption of the final

rules.

Proposed Rules Federal Register

68350 

Vol. 70, No. 217 

Thursday, November 10, 2005 

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 

AGENCY: Nuclear Regulatory 

Commission. 

ACTION: Advance notice of proposed 

rulemaking: Withdrawal. 

SUMMARY: The Nuclear Regulatory 

Commission (NRC) is withdrawing an 

advance notice of proposed rulemaking 

(ANPR) that presented possible changes 

to the regulations governing the release 

of radionuclides from licensed nuclear 

facilities into sanitary sewer systems. 

Changes 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. 

SUPPLEMENTARY INFORMATION: On 

February 25, 1994 (59 FR 9146), NRC 

published an ANPR to seek information 

to determine whether an amendment to 

its regulations governing the release of 

radionuclides from 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 Interagency 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 10 CFR 

20.2003. This regulation was published 

in the Federal Register (56 FR 23360; 

May 21, 1991) as part of an overall 

revision of NRC standards for protection 

against radiation. Licensees were 

required to implement this regulation by 

January 1, 1993. As 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), and 

sewage sludge. The current NRC 

regulations require that any licensed 

material 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 10 

as part of an overall reduction in 

effluent release limits. In addition to the 

limits in 10 CFR 20.2003, NRC 

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 (10 to 20 

percent) of their allowable limits, as 

described in NRC Regulatory Guide 

8.37, ‘‘ALARA Levels for Effluents from 

Materials Facilities,’’ dated July 1993. 

NRC also conducts periodic inspections 

to ensure that licensees are in 

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, 

‘‘Evaluation 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 10 microsieverts per year (μSv/ 

yr) (1 millirem per year (mrem/yr)) to 

930 μSv/yr (93 mrem/yr) for members of 

the public, using a deterministic 

scenario analysis and the reported 

radionuclide concentrations and/or 

discharges. The second part of the study 

estimated the maximum 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 

hypothetical, maximum exposures to 

workers ranged from zero to a dose 

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, 

Federal Register / Vol. 70, No. 217 / Thursday, November 10, 2005 / Proposed Rules 68351 

‘‘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 result, 

in large part, of NRC’s regulation, which 

was incorrectly based on the 

assumption that radioactive materials 

would flow through treatment systems 

and not concentrate.’’ In June 1994, a 

joint U.S. House of Representatives and 

Senate hearing (June 21, 1994; S. Hrg. 

103–1034) was held to officially release 

and address questions raised in the 

GAO report. At the hearing, NRC and 

EPA agreed to cooperate to develop 

guidance for POTWs 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 

demonstrated that some radioactive 

materials discharged into sanitary sewer 

systems reconcentrate in sewage sludge. 

However, the report concluded that the 

available data were not sufficient to 

assess the adequacy of the requirements 

in 10 CFR 20.2003 in preventing 

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. 

In 1996, the Association of 

Metropolitan Sewerage Agencies 

(AMSA) conducted a 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 indication that radioactive 

material in sewage sludge in the State of 

Washington poses a health risk. 

The Interagency 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 NRC (through the ISCORS) 

jointly conducted a voluntary survey of 

POTW sewage sludge and ash to help 

assess the potential need for NRC 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 NRC 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 

Radioactivity in Sewage Sludge: 

Radiological Survey Results and 

Analysis.’’ No widespread or 

nationwide public health concern was 

identified by the survey and no 

excessive concentrations 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. 

In February, 2005, the Sewage Sludge 

Subcommittee published a report, 

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 for 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 Radioactivity in 

Sewage Sludge: Recommendations on 

Management of Radioactive Materials in 

Sewage Sludge and Ash at Publicly 

Owned Treatment Works;’’ (EPA 832–

R–03–002B; 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 that 

the most significant levels of radioactive 

materials in POTWs are attributable to 

NORM. The dose modeling work 

indicated that, in general, the doses 

from licensed materials in sewage 

sludge present a 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 (10 CFR 

20.2003) as discussed in the ANPR. In 

addition, public comments indicated 

that several of the options discussed in 

the ANPR would be costly to implement 

and may not be consistent with efforts 

to maintain doses ALARA. For these 

reasons, NRC is withdrawing the ANPR. 

Public Comments on the Potential 

Changes to 10 CFR Part 20 

In the ANPR, NRC 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 excreta. 

The following is a summary of those 

comments and NRC responses. 

(1) Form of Material for Disposal 

The May 21, 1991, final rule (10 CFR 

20.2003) allows soluble and readily 

dispersible biological material to be 

released but prohibits the release of any 

non-biological insoluble material. 

Because NRC recognized that new 

technologies for wastewater treatment, 

such as ion-exchange and some types of 

biological treatment, can reconcentrate 

radionuclides, NRC invited comments 

regarding whether and how regulations 

should account for the effects of 

different wastewater treatment 

68352 Federal Register / Vol. 70, No. 217 / Thursday, November 10, 2005 / Proposed Rules 

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 Office, New York 

State Department of Environmental 

Conservation, AMSA, and the 

Department of Energy (DOE), expressed 

the view that the regulations should be 

reevaluated because of new sewage 

treatment technologies or should 

account for the effects of new 

technologies used to treat sewage or 

sewage sludge. One commenter 

suggested that NRC limits should 

account for a variety of POTW-specific 

factors, including sludge handling 

processes, and sludge disposal methods, 

and restrictions on the POTW’s treated 

water discharge. Another commenter 

suggested NRC 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 

reconcentration of radionuclides in 

sewage sludge. Two commenters 

recommended NRC develop technologyspecific reconcentration factors to help 

POTW operators to design appropriate 

pretreatment plans. A representative of 

DOE suggested NRC should expect that 

advances in the sewage treatment 

process would result in increasing 

concentration of radionuclides in 

sewage sludge. Two commenters 

recommended NRC regulations account 

for synergistic health effects of radiation 

and pollutants in wastewater, and one 

suggested NRC evaluate the synergistic 

effects of radiation and the chlorine and 

fluoride used in drinking water 

treatment. 

Response: NRC 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 NRC 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 NRC should keep 

informed of technological 

developments, but should not 

implement additional restrictions 

without significant evidence that the 

current restrictions are not adequate. 

Two commenters suggested that, rather 

than revising § 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 

the technology used at the treatment 

plant may cause doses above 100 mrem/ 

yr. One 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 into sanitary sewers, NRC notes 

that, as described in Section 4.7 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 of DOE expressed the 

view that changes to the regulations to 

account for multiple dischargers should 

be considered but may not be necessary 

because sanitary systems 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 cases in which the 

limits are being exceeded by licensees 

that were already discharging sewage 

into the sewer system before the limits 

were developed should be handled on a 

case-by-case basis. 

Response: NRC 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 forms of material suitable for 

release into sanitary sewers. Twenty-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 regulations, 

and also that it would be inappropriate 

for NRC 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 

retraining of personnel as expenses that 

would be incurred if additional 

restrictions were imposed. In addition, 

three commenters expressed the 

concern that further restricting the 

forms 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 minimal dose to 

members of the public or POTW 

workers that might be avoided. 

Response: NRC acknowledges the 

commenters’ remarks, which support 

Federal Register / Vol. 70, No. 217 / Thursday, November 10, 2005 / Proposed Rules 68353 

the withdrawal of the ANPR. However, 

the NRC staff notes the need to analyze 

samples of waste to determine if the 

waste contains insoluble radionuclides 

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 problems caused by the 

disposal of soluble radioactive material 

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: NRC 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 nonbiological dispersible materials should 

be allowed for materials that have halflives of 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 

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 radioactive 

material into sanitary sewers for the 

reasons previously explained. 

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 close contact with 

sewers, or who incinerate or use 

wastewater treatment sludge. In 

addition, the commenter remarked that, 

while it appeared to be reasonable to 

limit sewer releases to soluble and 

dispersible biological materials, NRC 

should realize that licensees could 

release insoluble or nondispersible 

materials to sewer systems 

inadvertently. One commenter 

expressed the view that NRC regulations 

should account not only for the form of 

material when released, but the form it 

was likely to take 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 

because POTWs are designed to remove 

dissolved contaminants from 

wastewater. However, both commenters 

expressed the opinion that 

reconcentration is not necessarily a 

problem if the dose any individual is 

expected to receive from exposure to 

sewers, sewage, or sludge is low. 

Response: NRC 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 addressed in the ISCORS 

dose modeling report (NUREG–1783), as 

previously explained. 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. NRC 

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, NRC staff 

notes that, in addition to restrictions on 

form, NRC 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. 

Response: NRC acknowledges the 

commenters’ support for additional 

restrictions on the forms of material 

suitable for release into sanitary sewers 

but is not changing the regulations 

because it believes the current approach 

is sufficiently protective, as previously 

explained. 

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 concern that it would be difficult to 

demonstrate compliance with the 

restriction that only soluble and readilydispersible 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 licensees should 

demonstrate the solubility of radioactive 

material released to 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 submit these 

68354 Federal Register / Vol. 70, No. 217 / Thursday, November 10, 2005 / Proposed Rules 

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 

(1Ci) 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 (10 

CFR 20.2003(a)(4)) to address concerns 

regarding the possibility for 

reconcentration of radionuclides. In the 

ANPR, NRC invited comments about the 

alternative approach of limiting the 

annual release of each radionuclide 

individually. NRC also invited 

comments about the current total 

quantity limits and the potential 

impacts that additional restrictions on 

the annual releases into sanitary sewers 

would have on licensees. 

Prior to publishing the ANPR, NRC 

received a petition for rulemaking to 

amend 10 CFR 20.303 (superseded by 

§ 20.2003) and § 20.305 (superseded by 

§ 20.2004) from the Northeast Ohio 

Regional Sewer District (PRM–20–22). A 

notice of receipt of the petition was 

published in the Federal Register (58 

FR 54071; October 20, 1993). The 

petitioner requested that NRC amend its 

regulations to require that all licensees 

provide at least 24 hours advance notice 

to the appropriate POTW before 

releasing radioactive material to the 

sanitary sewer system. The petitioner 

also requested that NRC exempt 

materials that enter the sanitary waste 

stream from the requirements regarding 

Commission approval for incineration 

under NRC’s current regulations. NRC 

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). 

Comment: Six comments received in 

response to the ANPR supported annual 

total 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 supported the 

total quantity limits because they are 

easy for licensees and regulators to 

understand and implement. Two 

commenters, including the 

representative of DOE, suggested it may 

be worthwhile for NRC 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: NRC acknowledges support 

for the current approach of using annual 

limits on the total quantity of 

radioactive material that can be released 

into sanitary sewers by a licensee. In 

accord with the commenters’

suggestion, NRC performed a study to 

evaluate the reconcentration of various 

radiounuclides in POTWs, the results of 

which are discussed in NUREG/CR–

6289. 

Comment: A representative of the City 

of Oak Ridge made positive and 

negative statements about NRC 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 quantity limits 

are inappropriate for low specific 

activity radionuclides because 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: NRC 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, such as Co-60. 

NRC has decided not to change the 

regulations governing sewer release of 

radioactive material for the reasons 

previously explained. NRC 

acknowledges the commenter’s 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 POTWs have 

some authority to impose limits on the 

release of material into sanitary sewers 

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–03–002B). 

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 should not attempt to impose total 

quantity limits on large facilities. 

Seventeen commenters expressed the 

view that NRC should consider relaxing 

the total quantity limits because of the 

new restriction on the 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 total quantity 

limits. Three commenters suggested 

that, instead of limiting the total 

quantity of radioactivity 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 limits are sufficient and 

are superior to total quantity limits 

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 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 

Federal Register / Vol. 70, No. 217 / Thursday, November 10, 2005 / Proposed Rules 68355 

ANPR. The commenter suggested 

reconcentration could be avoided by 

reducing the allowable concentrations 

of those radionuclides that have shown 

a tendency to reconcentrate in sewage 

sludge. 

Response: NRC 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. 

NRC 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 

limits. As discussed in NUREG/CR–

6289, the form of radionuclides can 

change upon entering a sewer or POTW 

because of sorption and precipitation. 

NRC also acknowledges the concern that 

total quantity limits did not prevent the 

cases of contamination discussed in the 

ANPR. NRC 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. 

NRC 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. NRC 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 

the view that additional limitations on 

the release of H-3 and C-14 into sanitary 

sewers would not produce any public 

health benefit because any dose an 

individual received from sewerdisposed H-3 and C-14 would be 

negligible in comparison to the dose the 

individual would receive from 

naturally-produced H-3 and C-14. 

Response: NRC 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 ANPR 

and the current total quantity limits 

which allow the annual release of 185 

GBq (5 Ci) of 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 biotechnical 

research, development, or medical 

practice, especially if the limits were 

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 would 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 radiopharmaceuticals 

suggested additional restrictions on the 

total quantity of radioactive material 

that could be released into sanitary 

sewers annually could harm public 

health and safety by causing companies 

to limit biomedical research and 

development efforts. One of 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 associated with biomedical 

research should be allowed as long as 

the exemption for patient 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 that the 

numerical limits in 10 CFR 20.2003 

would be lowered, although the 

university typically releases only 11.1 

Gbq (0.2 Ci) of radioactivity into 

sanitary sewers each year. 

Response: NRC 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: NRC acknowledges the 

commenter’s statement, but has decided 

not to change the total quantity limits 

because it believes the current approach 

is sufficiently protective for the reasons 

previously explained. 

Comment: Twenty-one letters 

received in response to the ANPR 

included comments on the Northeast 

Ohio Regional Sewer District’s request 

for NRC to amend its regulations to 

require that all licensees provide at least 

24 hours 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 some type of 

reporting on the radioactive materials 

released into the sanitary sewer system. 

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 sludge disposal and reuse. 

Fifteen of the twenty-one commenters 

did not support such a requirement for 

licensees to provide at least 24-hour 

68356 Federal Register / Vol. 70, No. 217 / Thursday, November 10, 2005 / Proposed Rules 

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 

regulations 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 daily depending on the number 

of patients treated and types of 

treatment used. 

Several commenters also noted that 

there could be large cost implications 

and regulatory burdens associated with 

such notification. In addition, 

commenters were concerned 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 NRC 

requirement for licensees to provide a 

24-hour advance notification was 

unnecessary because local 

municipalities have authority 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: NRC 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 the denial of the petition are 

discussed in the Federal Register notice 

published on January 27, 2005 (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 NRC 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 further regulation of the radioactive 

material is needed after release. One 

commenter did not support such an 

amendment and expressed the view that 

it would only serve to provide an openended system for radioactive material to 

pass into the environment and to the 

public without limitation or 

characterization. 

Response: NRC approval to 

incinerating waste is required to ensure 

that NRC may 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. 

Additional reasons for the denial of the 

petition are discussed in the Federal 

Register notice 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 calculated dose of 5 mSv/ 

yr (500 mrem/yr) due to ingestion of 2 

liters per day of a licensee’s effluent into 

the sanitary sewer. 

In the ANPR, NRC invited comments 

on this regulatory approach. 

Specifically, NRC 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, NRC invited comments 

about how other exposure scenarios, 

such as exposure to radionuclides in 

contaminated sludge, should be 

accounted for. NRC 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 on releases of 

radioactive material into sanitary sewers 

that have been addressed with the 

General Comments. 

Comment: Twenty-three commenters 

supported the current modeling 

approach of assuming that an individual 

ingests 2 liters of water taken from the 

licensee’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 to 

understand. A representative of DOE 

noted that the approach appears to be 

bounding, and 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 of 500 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 exposed to 

water directly downstream of a sewer 

outfall. Another commenter that 

supported 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 NRC 

assessments, and that considering a 

downstream location would be 

inconsistent with modeling exposure to 

the maximally exposed individual. 

Response: NRC 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 consume POTW 

effluent because the concentration of 

radionuclides in POTW effluent will 

have been diluted with effluent from all 

of the other residential and industrial 

dischargers to the POTW. 

Federal Register / Vol. 70, No. 217 / Thursday, November 10, 2005 / Proposed Rules 68357 

Comment: Three commenters 

expressed concern that the 

concentration limits are 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 CFR 20.1301 limit on 

doses to members of the general public 

from licensed activities. One commenter 

expressed the view that the 1 mSv (100 

mrem) annual public dose limit should 

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 CFR 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: NRC acknowledges the 

commenters’ concern about the 

hypothetical dose used as the basis for 

the concentration limits. As discussed 

in the ANPR, the NRC 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. 

NRC also acknowledges 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 10 CFR 20.1301 are 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 day. 

Almost all of these commenters 

expressed the view that the assumption 

is unrealistic. 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 overemphasize the potential impact of shortlived radionuclides. 

Response: NRC 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 staff notes that the assumption that 

an individual would consume a 

licensee’s effluent is used as 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 NRC should 

consider when developing restrictions 

on the release radioactive materials into 

sanitary sewer systems. Of these, five 

suggested NRC 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 NRC 

consider locations downstream of a 

POTW 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 NRC 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, NRC 

should consider that sludge could be 

sent to a landfill, applied to agricultural 

land, or made into compost for sale to 

the public. 

Five commenters, including 

representatives of POTWs and DOE, 

recommended NRC consider doses to 

sanitation workers and two commenters 

suggested NRC consider doses to 

workers that come into contact with 

sewage collection systems as well as 

POTW workers. One commenter noted 

the importance of matching exposure 

locations to appropriate pathways and 

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 NRC 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 

NRC regulations also should prevent 

contamination of sewers, POTWs, 

receiving waters, and sludge and ash 

disposal sites. Another commenter 

suggested NRC consider potential 

exposures to all POTW residuals, 

including sludge, screenings, grit, and 

ash. The commenter also pointed out 

that sewer pipes may leak and suggested 

NRC 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 NRC staff notes 

that several of the modeling scenarios 

suggested by the commenters, including 

sludge handling 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, 

NRC 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 not resulted in 

significant worker exposure have 

prevented POTWs from using or 

disposing of sewage sludge. 

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 (EPA 832–R–03–002B) provides 

guidance to assist POTW operators in 

reducing sources of 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 models should 

reflect limitations on access that are 

imposed to protect individuals from 

other health risks associated with 

sewage and sewage sludge. One 

68358 Federal Register / Vol. 70, No. 217 / Thursday, November 10, 2005 / Proposed Rules 

commenter suggested no model could 

adequately represent complex exposure 

scenarios because dose modeling was 

not sufficiently well developed. 

Response: The approaches the 

commenters suggested 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. NRC 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 which 

simple bounding assumptions are first 

used to evaluate compliance, and more 

complex models and more site-specific 

data are used only if the simple 

bounding model does not demonstrate 

compliance. Another commenter 

suggested that, if the appropriate models 

were developed, 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 the 

release of radionuclides into sanitary 

sewers are more restrictive than other 

NRC dose limits 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 

based on measured radionuclide 

concentrations from samples taken 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: NRC acknowledges the 

commenters’ support for sewer release 

restrictions to be expressed as limits on 

dose rather than activity. NRC also 

acknowledges the commenters’

suggestion that compliance with dose 

limits be made based on sample 

measurements. However, these options 

will not be implemented because the 

ANPR is being 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 NRC 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 

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 

could make it necessary for licensees to 

require prior approval for releases of 

radioactive 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 should be made, 

and the modeling assumptions to be 

used in compliance 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 

procedure. 

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 in sewage or 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 NRC would 

consider setting any non-zero dose limit 

for POTW workers. Both commenters 

expressed the view that any dose 

received by a POTW worker because of 

exposure to radionuclides released into 

sanitary 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 

NRC licensees. 

Response: NRC acknowledges the 

commenters’ concern about sanitary 

system worker doses but disagrees with 

the view that only a dose of zero could 

be ALARA. The staff notes 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 of a 

municipality suggested monthly 

averages should not be used because the 

practice encourages the use of dilution 

as a means of meeting the regulations. 

A representative of AMSA suggested 

daily averages 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 monthly averages. 

Response: NRC acknowledges the 

commenters’ suggestions about 

appropriate time periods over which 

releases should be averaged. NRC 

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 

Federal Register / Vol. 70, No. 217 / Thursday, November 10, 2005 / Proposed Rules 68359 

suggested should be included in a dose 

model included a radionuclide’s 

specific 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 that reconcentrate in 

POTWs to a significant extent and those 

that do not. Another commenter 

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 exposure to radionuclides that 

volatilize from sewage at a 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 that 

only a very few radionuclides would 

require reduced quantity limits even if 

the limits were conservative to bound 

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 Department of Health 

predicted it may be difficult for 

licensees to keep track of the quantity of 

each radionuclide released 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 (ALI) values as a basis for annual 

release limits for individual 

radionuclides, as suggested in the 

ANPR, because the ingestion pathway 

may not be the most significant 

exposure pathway and because the 

chemical 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 

individual radionuclides should be 

based on fractions, rather 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: NRC 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 NRC 

were to change the annual quantity 

limits, it should focus on Co-60, Sr-90, 

Cs-137, Ir-192, and Am-241, because 

these radionuclides were identified in 

NUREG/CR–5814 as having the 

potential to result in a significant dose, 

based on the pre-1991 release limits. A 

representative of the State of Illinois 

Department of Nuclear Safety 

recommended NRC change the total 

quantity limits only if the releases of Co60, Sr-90, Cs-137, Ir-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 10 

CFR part 20. 

Another commenter noted that, 

although limiting the quantities of 

radionuclides released would not 

necessarily be difficult, the need to 

analyze batches of wastewater to 

determine the quantities of individual 

radionuclides being released would be a 

significant burden as compared 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 used in 

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 pose to POTW workers or 

members of the general public once 

released to the sewer system. Several 

commenters noted the possibility that 

excreta could be spilled or inadequately 

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 exemption were 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 

68360 Federal Register / Vol. 70, No. 217 / Thursday, November 10, 2005 / Proposed Rules 

in the form of Tc-99m, which has a half 

life of 6 hours, 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 

NRC believes the regulation is adequate, 

as stated in the ANPR, there should not 

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 

tested by sanitary system staff routinely. 

Another hospital representative 

expressed the opinion that hospitals 

should not 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. 

Response: NRC acknowledges the 

commenters’ support for the exemption 

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 

dollars for patients undergoing 

therapeutic procedures and 62 billion 

dollars for patients undergoing 

diagnostic procedures, as of 1994. The 

American College of Nuclear Physicians 

and the Society of Nuclear Medicine 

jointly estimated that elimination of the 

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 with 

restrictions on the release of excreta to 

sewer systems. Five commenters 

predicted that it would be difficult to 

compel patients being treated on an outpatient 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 eliminated 

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 

someone else collect their excreta. One 

commenter noted that patient wellbeing would be compromised if patients 

needed to remain in the hospital so that 

their excreta could be managed because 

it would prolong the time away 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: NRC acknowledges the 

commenters’ concerns about the 

potential costs, legal implications, and 

impacts on patient care that may be 

caused by removing 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 NRC 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 NRC 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 NRC judgement 

about the appropriateness of the 

exemption once NRC 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 

Federal Register / Vol. 70, No. 217 / Thursday, November 10, 2005 / Proposed Rules 68361 

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 

Statement (EIS). The commenter stated 

an EIS would provide a ‘‘long-needed’’

record of the rationale for the decision 

to exempt patient excreta from the 

sewer release restrictions and the 

expected impacts of the exemption on 

the environment and public health. 

Response: NRC acknowledges the 

suggested modifications to the 

exemption of patient excreta and the 

suggestion that an EIS should be 

performed. However, those suggestions 

will 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 I–131 in sewage and 

sludge in one municipality’s POTW and 

expressed the concern that I–131 could 

be a source of radiation exposure to 

sanitary system workers. The 

commenter also expressed the concern 

that, although it has a short half life, Tc99m 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 I–

131 is very soluble, most of the I–131 

that entered a POTW would be 

discharged in the treated effluent and 

that the POTW’s effluent may, therefore, 

exceed NRC 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 NRC restrictions and 

can be a significant source of 

radioactivity in wastewater. 

Response: NRC acknowledges the 

commenters’ suggestion that the release 

of 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 on the release of patient 

excreta into sanitary sewers are not 

being imposed for the 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–03–002B) 

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 shortlived, 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 

radioisotopes used in medical 

procedures typically are short, as NRC 

stated in the ANPR, the burden of 

storing the excreta until the 

radioactivity decays to background 

levels should not be large. 

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 notes that comments about the 

regulations 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 situations when patients vomit. 

Comment: A representative of a 

company that manufactures equipment 

that 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 

commenter. 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 they would 

be required to return it to the 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 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 

received. The commenter also asked 

how a licensee would calculate the 

radioactivity released by each patient 

and whether records of the releases 

would need to be maintained by the 

licensee. 

Response: NRC acknowledges the 

many questions on this issue, but is not 

responding to them because the ANPR 

is being withdrawn. 

Comment: One commenter suggested 

NRC should exempt the excreta of 

animals used in biomedical research 

from the restrictions governing the 

68362 Federal Register / Vol. 70, No. 217 / Thursday, November 10, 2005 / Proposed Rules 

release of radioactive material into 

sanitary sewers. 

Response: NRC 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, NRC 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 governing 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 contamination, especially if 

some of those cases involved violations 

of the applicable regulations. 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 doses below the ALARA 

guidelines in NRC 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 

5 mSv (500 mrem). Two commenters 

suggested the risk of adverse health 

effects 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 POTWs appear to be within 10 

CFR part 30 limits for general licensees. 

Response: NRC 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 CFR 

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 

CFR 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 NRC 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 CFR 

part 20. One commenter expressed the 

opposite view and stated that the NRC 

should not assume that the changes 

made to 10 CFR part 20 in 1991 would 

eliminate contamination of POTWs with 

licensed radioactive materials. 

Response: NRC acknowledges the 

commenters’ recommendation that it 

study the effect of the changes made to 

10 CFR part 20 in 1991 on the amount 

of radioactive material at POTWs. The 

NRC 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 the effects of the 1991 

revision of the regulation. 

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: NRC 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 

disposal 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 in 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 encumber facilities that perform 

medical research, and requested that 

educational and medical research 

institutions be exempted from the 

regulations 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 specific practices 

used in medical research facilities be 

provided by NRC. Another commenter 

proposed that the regulation should 

explicitly permit disposal of medical 

diagnostic products in aqueous mixtures 

that contain less than 370 kBq (10 

microcuries) of radioactivity and which 

are composed of isotopes with half-lives 

less than 61 days. 

Response: NRC 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. NRC 

acknowledges that guidance written 

specifically for medical research 

facilities would be helpful to some 

licensees, 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 NRC 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 of 

Federal Register / Vol. 70, No. 217 / Thursday, November 10, 2005 / Proposed Rules 68363 

radioactive material. The commenter 

also recommended NRC contact AMSA 

and industry trade groups to obtain 

additional information about variations 

and trends in wastewater treatment 

technologies, practices, and regulations. 

Response: NRC 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, NRC participated in the 

ISCORS sewage sludge survey (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 

NRC 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 NRC 

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: NRC 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 NRC 

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 problems with the revised 

rule. The commenter expressed concern 

that user fees were used to support a 

National Council on Radiation 

Protection study of the number of 

various types of nuclear medicine 

procedures performed annually as of 

1989. The commenter also expressed 

concern that any change in NRC 

regulations governing the release of 

radioactive materials 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 taxes to support EPA. 

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 use 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 because 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, 

NRC notes that the ANPR invited 

comment but did not require a response. 

In addition, NRC notes that the ANPR 

invited comment on a variety of issues 

and was not limited to a request for 

information to support the derivation of 

concentrations of radionuclides in 

sewage. 

NRC 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 uses 

of radionuclides. 

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 NRC 

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 contaminated 

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, Cs137, uranium isotopes, and I-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 control releases of radioactive 

materials into the sanitary sewers and 

provided a reference that describes the 

approach that has been taken to control 

radioactive materials through the 

municipality’s industrial pretreatment 

program. 

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 

concerns from the public and from 

workers that had cost the district, as of 

1994, $1.5 million to 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. 

68364 Federal Register / Vol. 70, No. 217 / Thursday, November 10, 2005 / Proposed Rules 

Response: NRC 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 and 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. 

NRC 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 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 ‘‘reconcentration’’ as the 

cause of contamination problems is 

misleading and noted that, at one POTW 

in the district, it appeared that particles 

of 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 prevent 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, because 

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 sewers. Three of the 

commenters expressed the concern that, 

although municipalities are held 

responsible for the disposal or beneficial 

use of POTW sludge, the municipalities 

have no control over the radioactivity of 

materials discharged to the sewer 

system that affect sludge quality. One 

commenter expressed the concern that 

the existing regulatory framework is 

inadequate because NRC maintains that 

the party in possession of the 

radioactive material is responsible for 

remediation, offers no assistance to 

POTWs that have been contaminated by 

a licensee’s effluent, and states that the 

AEA indicates that its regulations 

preempt more restrictive local 

regulations. The commenter expressed 

concern that NRC has indicated that this 

position would not change even if NRC 

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 NRC should 

either assume responsibility for 

disposing of radioactive sludge 

generated in POTWs as a result of 

‘‘errant discharge’’ from NRC 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, NRC 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 NRC to develop new regulations that 

would limit the disposal of radioactive 

material into sanitary sewers because 

POTWs already had the 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: NRC 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 held that, for certain activities 

covered by the AEA, Federal authority 

preempts other regulatory authorities 

whose purpose is radiation protection. It 

is difficult to predict whether unusual 

cost to the POTW caused by radioactive 

effluent discharges would be 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 and Section 7.2 of the ISCORS 

recommendations on management of 

radioactive 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 NRC 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 program. 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 

Federal Register / Vol. 70, No. 217 / Thursday, November 10, 2005 / Proposed Rules 68365 

biosolids, and then allocating that limit 

among industrial facilities that 

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, 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 NRC 

coordinate any future regulations 

affecting sanitary sewer discharges with 

EPA requirements for Clean Water Act 

discharges, 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, 

NRC 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 NRC 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 sludge 

and ash (EPA 832–R–03–002B), 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 difficult to 

determine. The commenter also 

expressed concern that licensees would 

need to obtain prior approval for sewer 

discharges, and that regulatory agencies 

would need to keep track of separate 

discharge allotments for each licensee 

and any changes to each POTW’s 

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 

POTW, or the number of dischargers 

discharging to the POTW. The 

commenter noted that this approach 

would not require as much regulatory 

oversight and suggested these 

approaches should be evaluated in an 

EIS. 

Response: NRC 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 NRC decommissioning 

standards and various EPA rules and 

suggested NRC hold public hearings on 

the issue. 

Response: NRC is not responding to 

the request for clarification on the 

relationship between the proposed rule 

and EPA or NRC standards because the 

ANPR is being withdrawn. 

Comment: Ten commenters expressed 

the view that any change to the 

regulations governing the release 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 expressed the concern that 

changes to the regulations would be 

made for reasons other than technical 

reasons, including regulatory 

convenience, a perception of public 

opinion, or political pressure. 

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 technical basis. 

The commenter expressed the view that, 

except for the exemption of patient 

excreta, all of the options discussed in 

the ANPR required more analysis before 

NRC 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 NRC 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 NRC 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 NRC 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 NRC 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 

NRC cooperate with EPA, POTWs, and 

affected industries to assess the 

exposure and contamination pathways 

of radionuclides, and the impact of 

radioactive materials on wastewater 

treatment processes. 

Response: NRC acknowledges the 

commenters’ view that the 1991 revision 

to the regulations governing the release 

of radioactive materials into sanitary 

sewers should have been based upon 

detailed risk analyses. As discussed 

previously, NRC cooperated with 

representatives of EPA and POTWs in 

developing the ISCORS survey and dose 

modeling project to assess the 

radioactive contamination in POTWs 

and pathways for exposure of POTW 

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, 

68366 Federal Register / Vol. 70, No. 217 / Thursday, November 10, 2005 / Proposed Rules 

recommended NRC study the extent of 

the use of sewer discharges and 

contamination of POTWs around the 

country. The representative of AMSA 

suggested that, because NRC 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, 

NRC should establish a task force 

composed of NRC 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 NRC determine which 

licensees release radioactive material 

into sanitary sewers and two of these 

commenters recommended NRC 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 been able to provide a list 

of the licensees discharging into the 

district’s sewer system and that the 

district had, therefore, been unable to 

initiate an appropriate monitoring 

program. 

Response: NRC 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 ISCORS 

recommendations on management of 

radioactive materials in sewage sludge 

and ash (EPA 832–R–03–002B), POTW 

operators are encouraged to contact the 

applicable NRC 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 NRC had the information 

necessary to help POTWs develop 

protective limits. 

Response: NRC 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 NRC 

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 

NRC 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 NRC’s development of standards 

for the protection against radiation are 

beyond the scope of this rulemaking. 

Comment: Three commenters 

recommended NRC perform a cost/ 

benefit analysis of 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 NRC to 

apply the backfit provisions that apply 

to power reactors to a broader scope of 

rulemaking decisions, and expressed the 

view that the alternatives suggested in 

the ANPR could not be justified in a 

backfit analysis. 

Response: NRC 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 NRC’s backfit provisions 

are beyond the scope of this rulemaking. 

Comment: One commenter expressed 

the concern that limits based on overlysimplified dose models could be overlyrestrictive and could cause unintended 

harm to the public by limiting beneficial 

uses of radioactive materials. The 

commenter suggested NRC consider the 

‘‘total societal impact’’ of its release 

limits, and expressed the view that NRC 

and other regulatory agencies typically 

perform inadequate assessments of the 

financial impacts of their rules. The 

commenter added that NRC 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 

evaluation of cost, benefit, and total 

societal impact is inherently included in 

the concept of maintaining doses 

ALARA. 

Response: NRC acknowledges the 

commenter’s concern about the 

adequacy of financial impact analyses 

performed by NRC and other regulatory 

agencies. NRC staff agree that, as 

defined in 10 CFR 20.1003, the term 

‘‘ALARA’’ indicates consideration of 

societal and socioeconomic impacts. 

Comment: Five commenters 

expressed the opinion that, in general, 

any changes to the regulations should 

allow less radioactive material to be 

released into sanitary sewers. Reasons 

for this position included new 

information about the adverse effects of 

chronic exposure to low 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 storage or 

disposal facilities. Another commenter 

stated that NRC should 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, NRC made several inquiries 

about the impacts of new restrictions on 

licensees 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 

Federal Register / Vol. 70, No. 217 / Thursday, November 10, 2005 / Proposed Rules 68367 

licensees, rather than the public, to bear 

the expense of the disposal of 

radioactive materials used by licensees. 

The other commenter suggested NRC 

should have solicited comments 

regarding the potential impact of the 

regulations on public health, healthcare 

costs, contamination of agricultural 

land, restriction of land uses, and 

environmental 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, licensees 

must recognize that safety of the 

community is more important than the 

desire for a 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 adverse 

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 handling and transportation of 

waste that would occur if releases of 

radioactive material to sanitary sewers 

were eliminated. 

One commenter also suggested that, 

because radioactivity can exist in sewer 

systems 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 discharge. Another 

commenter suggested incidents of 

contamination should be handled in 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 defeat ‘‘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 safely and in accordance 

with good practices and license 

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 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–

1775) and, therefore, reflect any 

accidental releases that may have been 

made 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 NRC 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 need 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 that many 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 relative inaccessibility of 

LLW disposal and noted that most types 

of LLW do not meet the requirements 

for release into sanitary sewers. 

Response: NRC acknowledges the 

commenters’ concerns regarding the 

impact that the proposed changes would 

have because of some licensees’ lack of 

access to LLW disposal facilities. These 

comments support the withdrawal of 

the ANPR. 

NRC also acknowledges the 

commenter’s concern that limitations on 

LLW disposal could lead to an increase 

in the release of radioactive material to 

sanitary sewers. The NRC staff notes 

that the results of the ISCORS sewage 

sludge survey (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 

68368 Federal Register / Vol. 70, No. 217 / Thursday, November 10, 2005 / Proposed Rules 

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 NRC licensees 

should bear the costs of data collection, 

data reporting, and worker training 

needed to implement any new NRC 

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: NRC acknowledges the 

commenter’s suggestion that NRC’s 

descriptions of case studies should 

include information about the economic 

aspects 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 NRC enforcement 

actions. A representative of DOE stated 

that it was unclear 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 POTWs. 

Three commenters suggested NRC or 

POTWs should verify licensee’s 

reported discharges into sanitary sewers 

and one commenter suggested 

compliance with NRC regulations 

should be demonstrated at the licensee’s 

outfall into the sanitary sewer system so 

that POTWs would not be impacted and 

would not need to implement 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 NRC should assist POTWs 

with monitoring of licensee’s effluents 

and enforcement of the discharge limits. 

Response: NRC 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 safety 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 locations for monitoring a 

licensee’s effluent are beyond the scope 

of the proposed rulemaking. 

Comment: A representative of the 

New York State Department of 

Environmental 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 NRC intends to 

apply to each provision so that 

Agreement States and other interested 

parties can participate in decisions 

about compatibility 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 NRC having determined 

compatibility requirements and stated 

that this type of situation must not 

recur. 

Response: NRC 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 environment 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 commenter 

asked specific questions about the 

assumptions 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.’’

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. NRC acknowledges the 

commenter’s concern regarding 

contamination at POTWs. The 

commenter’s specific questions about 

the modeling assumptions used to 

calculate doses for the case studies 

discussed in the ANPR are addressed in 

NUREG/CR–1548. NRC notes that its 

definition of ‘‘background radiation,’’

provided in 10 CFR 20.1003, excludes 

contributions of radioactivity from 

source, byproduct, or special nuclear 

materials regulated by NRC. 

For the reasons cited in this document, 

NRC withdraws this ANPR. 

Dated at Rockville, Maryland, this 11th day 

of October, 2005. 

For the Nuclear Regulatory Commission. 

Luis A. Reyes, 

Executive Director for Operations. 

[FR Doc. 05–22432 Filed 11–9–05; 8:45 am] 

BILLING CODE 7590–01–P 

SMALL BUSINESS ADMINISTRATION 

13 CFR Part 121 

RIN 3245–AF28 

Small Business Size Standards; 

Security Guards and Patrol Services 

AGENCY: U.S. Small Business 

Administration. 

ACTION: Proposed rule. 

SUMMARY: The U.S. Small Business 

Administration (SBA) proposes to 

increase the size standard for the 

Security Guards and Patrol Services 

Industry (North American Industry 

Classification System (NAICS) 561612)