[Federal Register Volume 70, Number 17 (Thursday, January 27, 2005)]
[Proposed Rules]
[Pages 3898-3902]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-1485]


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 Proposed Rules
                                                 Federal Register
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 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.
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  Federal Register / Vol. 70, No. 17 / Thursday, January 27, 2005 / 
Proposed Rules  

[[Page 3898]]



NUCLEAR REGULATORY COMMISSION

10 CFR Part 20

[Docket No. PRM-20-22]


Northeast Ohio Regional Sewer District; Denial of Petition for 
Rulemaking

AGENCY: Nuclear Regulatory Commission.

ACTION: Denial of petition for rulemaking.

-----------------------------------------------------------------------

SUMMARY: The Nuclear Regulatory Commission (NRC) is denying a petition 
for rulemaking (dated August 2, 1993, Docket No. PRM-20-22) submitted 
by the Northeast Ohio Regional Sewer District (the District or the 
petitioner). The petitioner requested that NRC amend its regulations to 
require all licensees to provide no less than 24 hours advance notice 
to the appropriate sewage treatment plant before releasing radioactive 
material into a sanitary sewer system, and to exempt radioactive 
materials that enter the sanitary waste stream from the requirements 
regarding NRC approval for incineration. NRC is denying the petition 
because it has been determined that current NRC regulations for 
discharge of licensed material into sanitary sewer systems are adequate 
and that current regulations for NRC approval for treatment or disposal 
of licensed material by incineration are necessary to ensure the 
protection of public health and safety and the environment.

ADDRESSES: Copies of the petition for rulemaking, the public comments 
received, and the NRC's letter to the petitioner may be examined at the 
NRC Public Document Room, O1F21, One White Flint North, 11555 Rockville 
Pike, Rockville, Maryland.
    The NRC maintains an Agencywide Document Access and Management 
System (ADAMS), which provides text and image files of NRC's public 
documents. These documents may be accessed through the NRC's Public 
Electronic Reading Room on the Internet at http://www.nrc.gov/reading-rm/adams.html. If you do not have access to ADAMS or if there are 
problems in accessing the documents located in ADAMS, contact the NRC 
Public Document Room Reference staff at 1-800-397-4209, (301) 415-4737, 
or by e-mail to [email protected].

FOR FURTHER INFORMATION CONTACT: Lydia Chang, Office of Nuclear 
Material Safety and Safeguards, U.S. Nuclear Regulatory Commission, 
Washington, DC 20555-0001, telephone (301) 415-6319, e-mail 
[email protected].

SUPPLEMENTARY INFORMATION:

The Petition

    By letter dated August 2, 1993, the District submitted a petition 
for rulemaking to amend 10 CFR 20.303 (superceded by 20.2003) and 
20.305 (superceded by 20.2004). The petitioner requested that NRC 
modify its regulations to require that all licensees provide no less 
than 24 hours advance notice to the appropriate sewage treatment plant 
before releasing radioactive material into a sanitary sewer system, and 
to exempt radioactive materials that enter the sanitary waste stream 
from the requirements regarding NRC approval for incineration. The 
petitioner stated that their Southerly Wastewater Treatment Center had 
been contaminated from releases of radioactive material containing 
cobalt-60 into its sanitary sewer system, resulting in costly 
characterization and remediation. The petitioner stated that the 
District was not the first sewage treatment authority to experience 
radioactive contamination and noted that NRC had documented radioactive 
contamination problems at other sewage treatment sites. The petitioner 
also stated that contamination may exist undetected at other sewage 
treatment plants and requested that the regulations be amended.

Public Comments on the Petition

    A notice of receipt of the District's petition was published in the 
Federal Register (58 FR 54071; October 20, 1993). The public comment 
period closed on January 3, 1994. NRC received twelve comment letters 
in response to the petition prior to the closing date. Ten of the 
twelve comment letters addressed the District's request for NRC to 
amend its regulations to require that all licensees provide at least 24 
hours advance notice to the appropriate sewage treatment plant before 
releasing radioactive material into a sanitary sewer system. Three 
commenters supported the District's request for providing a 
notification to the sewage treatment plant, but one commenter said that 
licensees and sewage treatment plant staff could agree on the provision 
of a report without making it a requirement in the Federal regulations. 
Six commenters did not support the District's request for such an 
amendment. Several comments said that such a requirement would be an 
unnecessary burden that would neither increase radiation safety nor 
reduce radiation exposures. Another commenter noted that it would be 
difficult to schedule ``batch'' releases because radioactive materials 
are used in continuous drug research and development processes, and, as 
such, discharges into the sanitary sewer are continuous as well. One 
commenter believed that no radioactive waste should be deposited in any 
sewer system by any licensee for any reason.
    Eight of the twelve letters commented on the District's request to 
exempt radioactive materials that entered the sanitary waste stream 
from the requirements regarding NRC approval for incineration. Two 
commenters were supportive of this part of the petition. Four 
commenters were opposed to this request because they believed that it 
was another attempt to declare radioactive materials entering sanitary 
sewer systems as being ``Below Regulatory Concern,'' as the exemption 
would only increase contamination as in the already documented cases, 
and it would pose a serious threat to the health and safety of 
populations surrounding facilities that incinerate radioactive 
materials. Two commenters cited the need for additional NRC review/
guidance on this issue in order to clarify at what point radioactive 
material is no longer under regulatory control.
    NRC published an advance notice of proposed rulemaking (ANPR) in 
the Federal Register (59 FR 9146; February 25, 1994) to determine 
whether an amendment to its regulations governing the release of 
radioactive material from licensed facilities into sanitary sewer 
systems was needed, based on current sewage treatment technologies. The 
ANPR noted receipt of the petition for

[[Page 3899]]

rulemaking submitted by the District (PRM-20-22) and specifically 
requested comments on the two issues raised in the petition.
    Twenty-one letters received in response to the ANPR included 
comments on the District's request for the NRC to amend its regulations 
to require that all licensees provide at least 24 hours advance notice 
to the appropriate sewage treatment plant 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--from the petitioner's request for a 24-hour 
advance notification before licensees release radioactive material, to 
monthly or annual discharge reports, to reports of releases that could 
be a threat to the publicly-owned treatment works (POTW) workers or the 
environment, to notification of large accidental releases.
    Fifteen of the twenty-one commenters did not support such a 
requirement for licensees to provide at least 24-hour advance notice to 
the appropriate sewage treatment plant before releasing radioactive 
material into a sanitary sewer system. Several commenters said that a 
24-hour advance notification would result in an unnecessary regulatory 
burden, with no additional radiation safety protection nor dose 
reduction. These commenters indicated 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 ``as 
low as reasonably achievable'' (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 potentially there would be large 
cost implications and regulatory burdens associated with such 
notification. In addition, commenters were concerned about having these 
reports received and interpreted by sewage treatment plant personnel, 
rather than radiation safety specialists, resulting in potential 
misinterpretation of the data. Several commenters offered 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.
    Six comment letters received in response to the ANPR included 
comments on the District's request that the NRC exempt materials that 
enter the sanitary waste stream from requirements 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. If release into a sanitary sewer 
system is to be considered disposal, these commenters indicated, the 
limits should be set so that no further regulation of the radioactive 
material is needed after release into a sanitary sewer. One commenter 
did not support such an amendment because it would only serve to 
provide an open-ended system for radioactive material to pass into the 
environment and to the public without limitations or characterization. 
Another commenter supported sole use of concentration limits for 
measuring a licensee's limits for disposal of radioactive material into 
sanitary sewer systems.

Discussion

Regulatory Framework Relevant to the Petition

    NRC regulations governing the discharge of licensed material by 
release into sanitary sewer systems and the treatment or disposal of 
licensed material by incineration can be found in 10 CFR 20.2003 and 
20.2004, respectively. These regulations were published in the Federal 
Register (56 FR 23360; May 21, 1991) as part of an overall revision of 
NRC's standards for protection against radiation. The licensees were 
required to implement these regulations by January 1, 1993. Although 
the District filed its petition after the implementation date of the 
1991 revision of 10 CFR part 20 regulations, the sewage sludge and ash 
from the District's Southerly Wastewater Treatment Center were 
contaminated prior to the implementation date.
    As part of the 1991 revision of 10 CFR part 20 regulations, NRC 
examined several instances where radioactive material was detected in 
sewage treatment systems. The results of this examination led to 
modifications of the requirements for disposal of licensed material by 
release into sanitary sewer systems in 10 CFR 20.2003. Specifically, 
NRC removed the broad provision that allowed the disposal of 
dispersible materials into sanitary sewer system. The disposal of non-
biological insoluble materials is no longer permitted because of 
potential reconcentration of these materials in the sanitary sewer 
system, sewage treatment plants, and sewage sludge. The current NRC 
regulations require that any licensed material discharged into a 
sanitary sewer system must be readily soluble (or is readily 
dispersible biological material) in water. In addition, the 
concentration limits for radionuclides released into a sanitary sewer 
system were reduced by a factor of 10 as part of an overall reduction 
in effluent release limits. The concentration limits were reduced 
because of past contamination incidents involving cobalt-60 and 
americium-241. The revised concentration limits, listed in Table 3 of 
the Appendix B to part 20, were an effort to reduce the public's 
exposure to radionuclides released into the sanitary sewer system. In 
addition, NRC recommends that licensees should set ALARA goals for 
effluents at a modest fraction (10 to 20 percent) of their allowable 
limits as stated 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.
    A number of comments, received during the 1991 revision of 10 CFR 
Part 20, questioned the need for the requirements that incineration of 
radioactive material requires specific prior NRC approval. After these 
comments were analyzed and considered in developing the final rule, NRC 
did not revise the provision regarding Commission approval for 
treatment or disposal by incineration except for waste oil. In the 
``Statements of Consideration'' for the final rule, NRC stated:

    Relaxation of the prior approval requirement for incineration 
was considered in connection with the amendments to part 20 of this 
final rule. The requirements for prior NRC approval of incineration 
remains in the amendments to part 20 in this final rule because the 
acceptability of incineration as a disposal option, except for 
exempted quantities of radioactive materials, must be determined on 
a site-specific basis considering: (1) Incinerator design, (2) the 
variable isotopic composition and activity of the material to be 
burned, and (3) potential human exposure to effluents, which may

[[Page 3900]]

require special calculational methods because of complex 
meteorologic conditions and other factors.

    As part of the 1991 revision of 10 CFR part 20, it was authorized 
that a licensee may treat or dispose of licensed material contained in 
certain waste oil by incineration without prior NRC approval. In making 
this regulatory change, the NRC staff analyzed the type of 
radionuclides and their potential concentrations in waste oil, 
performed atmospheric dispersion modeling to characterize potential 
hazards from incineration, and evaluated the potential environmental 
impact. The regulatory basis for requirements in obtaining NRC approval 
prior to incineration is 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 highly depend on the specific characteristic of 
the sludge such as the presence of radioactive materials, which could 
potentially have a broad spectrum of radionuclides and a wide range of 
concentration levels. The petitioner's request to incinerate sewage 
sludge without prior NRC approval is not supported by any detailed 
data, and has the potential to be inconsistent with the petitioner's 
basis for requesting an amendment to 10 CFR 20.2003. If petitioner is 
concerned with potential contamination of radioactive material in the 
sewage sludge, incineration of such sewage sludge without prior NRC 
approval would potentially not be protective to the public health and 
safety and the environment.

Surveys, Studies, and Reports Relevant to the Petition

    In May 1992, the 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 known 
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 ([mu]Sv/yr) (1 millirem per year (mrem/yr)) 
to 930 [mu]Sv/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 natural background.
    In May 1994, the U.S. General Accounting Office (GAO, now U.S. 
Government Accountability Office) issued a report, GAO/RCED-94-133, 
``Nuclear Regulation: Action Needed to Control Radioactive 
Contamination at Sewage Treatment Plants,'' that described nine cases, 
including the District, where contamination was found in sewage sludge 
or ash or in wastewater collection systems. On the basis of the limited 
information available on radiation levels in sewage sludge and ash 
across the country, GAO concluded that the full extent of contamination 
nationwide is unknown. The 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.'' The GAO report did note that 
to address the problem of radioactive materials' concentrating in 
sludge and ash, the NRC has revised its regulation to reduce the 
concentration levels of the radioactive materials that licensees can 
discharge into sanitary sewer systems although the GAO report also 
pointed out that ``NRC does not know how effective this action will 
be.'' The GAO report stated that health implications of the exposure of 
treatment plant workers and the public to contaminated sludge, ash, and 
related by-products are unknown because neither the NRC nor the United 
States Environmental Protection Agency (EPA) knows (1) how much 
radioactive material may be in these products and (2) how these 
products might affect people.
    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. These hearings 
were prompted by concerns associated with elevated levels of 
radioactivity in incinerator ash at the Cleveland treatment plant 
referenced in the District's petition. The testimony presented by both 
NRC and EPA during the hearing noted that there was no indication of a 
widespread problem, and that the District's incident appeared to be an 
isolated event. However, at the hearing, NRC and EPA committed to 
jointly 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, the NRC 
published NUREG/CR-6289, ``Reconcentration of Radioactive Material 
Released to Sanitary Sewers in Accordance with 10 CFR Part 20.'' The 
objectives of this study were to: (1) Assess whether radioactive 
materials that are released into sanitary sewer systems undergo 
significant reconcentration within the wastewater treatment plant, and 
(2) determine the physical and/or chemical processes that may result in 
their reconcentration within the wastewater treatment plant. A review 
of the literature clearly demonstrated that some radioactive materials 
discharged into sanitary sewer systems are reconcentrated in sludge 
produced as a result of wastewater treatment. 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 concentrations in sewage sludge at levels 
which present undue risk to the public; nor is the available data 
sufficient to suggest strategies for changing that requirements.
    In 1996, the Association of Metropolitan Sewerage Agencies (AMSA) 
conducted a limited survey of concentrations 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 doses from 
radionuclides in sewage sludge are extremely low compared to background 
or to generally accepted regulatory dose limits, and that there is no 
indication that radioactive material in biosolids in the State of 
Washington poses a health risk.

[[Page 3901]]

    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. Although the survey and sampling were biased towards 
facilities with greater potential for the presence of licensed material 
and NORM, ISCORS did not make a conclusion about the bias of the 
results. 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 were attributable to NORM, such as radium, 
rather than man-made sources. With the exception of NORM, most of the 
other samples were at or near the limit of detection. The results of 
this survey are consistent with the AMSA survey noted above.
    The Sewage Sludge Subcommittee is in the process of finalizing a 
draft report, NUREG-1783, ``ISCORS Assessment of Radioactivity in 
Sewage Sludge: Modeling to Assess Radiation Doses.'' This report 
contains computer modeling information, seven different sewage sludge 
management scenarios, and doses calculated by using modeling process 
that converts known activity concentrations in sludge to potential 
doses to individuals. Using survey results with the dose modeling, the 
calculated doses showed that 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.
    The Sewage Sludge Subcommittee is also in the process of finalizing 
a draft final report, EPA 832-R-03-002B, ``ISCORS Assessment of 
Radioactivity in Sewage Sludge: Recommendations on Management of 
Radioactive Materials in Sewage Sludge and Ash at Publicly Owned 
Treatment Works,'' November 2003. This report provides guidance to: (1) 
Alert POTW operators, and State and Federal regulators to the 
possibility of radioactive materials concentrating in sewage sludge and 
incinerator ash; (2) inform them how to determine whether there are 
elevated levels of radioactive materials in their sludge or ash; and 
(3) assist them in identifying actions for reducing potential radiation 
exposure from sewage and ash.

Reasons for Denial

    NRC is denying the petition because it has been determined that 
current NRC regulations in 10 CFR 20.2003 and 20.2004 adequately ensure 
the protection of public health and safety and the environment.
    With regard to the petitioner's request to amend 10 CFR 20.2003, 
NRC has reviewed the petitioner's rationale, the public comments on the 
petition and on the ANPR, and a number of relevant activities, surveys, 
and reports to determine whether there was a health and safety issue 
due to the reconcentration of radioactive materials in sewage sludge 
and ash, and if so, was the requested amendment for 24 hours advance 
notifications necessary to help prevent excessive exposures to workers 
and the public.
    The current requirements in 10 CFR 20.2003 were not fully 
implemented at the time of contamination at the District's Southerly 
Wastewater Treatment Center. The NRC significantly decreased the 
concentration limits for radionuclides discharged into sanitary sewer 
systems as part of the 1991 revision of 10 CFR Part 20, and licensees 
were required to comply with the regulatory changes as of 1993. In 
addition to lowering the concentration limits, the disposal of non-
biological insoluble materials was prohibited because of potential 
reconcentration of these materials in sanitary sewer systems, treatment 
plants, and sludge. NRC also has issued guidance to further reduce the 
effluent limits through use of ALARA goals. In addition, NRC conducts 
periodic inspections to ensure that licensees are in compliance with 
NRC regulations. Under this current regulatory framework, NRC expects 
that doses from release of licensed material into a sanitary sewer 
system are within regulatory limits.
    The available data do not support the District's assertion that 
health and safety protection would be enhanced by advance notification 
from all licensees to the appropriate sewage treatment plant. The 
ISCORS final survey report shows that NORM constitutes the most 
significant levels of radioactive materials in POTWs, and therefore any 
notification requirement imposed on licensees will not effectively 
reduce the level of radioactive materials in POTW facilities. Effluent 
levels from NRC-licensed activities are established in order to 
maintain doses to the public at or below a pre-determined protective 
level. The ISCORS draft dose modeling report shows that calculated 
doses to POTW workers and the public are sufficiently low from 
discharge of the licensed material into sanitary sewer systems, based 
on radionuclide concentrations in the sewage sludge and the associated 
sewage sludge management practices.
    NRC has determined that a requirement for an advance notification 
would impose an unnecessary regulatory burden on licensees, without a 
commensurate health and safety protection of the public. Such a 
requirement for advance notification would also be considered as an 
information request burden under the Paperwork Reduction Act of 1995 
(44 U.S.C. 3501 et seq.). This burden is broadly defined, and any 
method of notification imposed by an Agreement State or the NRC, 
including telephonic or electronic, is applicable. The regulatory 
burden proposed by the District is large, due to the large number of 
licensees that discharge to sanitary sewer systems. In addition, there 
is no justification on how the notification would be used at the 
wastewater treatment plant to affect treatment operations in response 
to a discharge of licensed material to ensure protection of health and 
safety.
    Finally, several commenters stated that it would be impractical, if 
not impossible, for all licensees to provide advance notices to the 
appropriate sewage treatment plant because of the nature of the process 
involved. Very small quantities of radioactive materials are 
continuously used at certain licensed facilities, such as drug research 
and development companies, and these radioactive materials are 
continuously discharged into sanitary sewer systems. Discharges from 
clinics and hospitals would have many fluctuations depending on the 
number of patients treated and the types of treatment used. It would be 
unreasonable to expect licensees to notify the sewage treatment 
facility prior to each discharge. It would also be equally 
unreasonable, in some cases, to expect licensees to collect

[[Page 3902]]

discharges in order to schedule for a batched discharge.
    In summary, NRC has concluded that the public comments, data, 
analyses, reports, and petitioner's rationale do not justify the 
petitioner's request for a rulemaking to amend the regulations in 10 
CFR 20.2003 to require that all licensees provide no less than 24 hours 
advance notification to the appropriate sewage treatment plant before 
releasing radioactive material into a sanitary sewer system. Such a 
rulemaking would impose unnecessary regulatory burden on licensees and 
does not appear to be warranted for the adequate protection of public 
health and safety and the common defense and security. Therefore, NRC 
is denying the petitioner's request to amend 10 CFR 20.2003.
    With respect to the petitioner's request to amend 10 CFR 20.2004, 
NRC has reviewed the petitioner's rationale, the public comments on the 
petition, and the regulatory history on the requirements for NRC 
approval for incineration. NRC regulations in 10 CFR 20.2004 apply to 
either an NRC or an Agreement State licensee and generally do not apply 
to a POTW or its operations. POTWs are not required to obtain NRC 
approval for incineration of their sewage sludge, unless they possess 
an NRC or Agreement State license for possession of licensed 
radioactive material in the sewage sludge. Studies, surveys, and 
modeling efforts conducted to date indicate that releases of 
radioactive material from licensed facilities in accordance with 10 CFR 
20.2003 generally do not reconstitute in sewage sludge in sufficient 
concentrations to pose a risk to public health and safety and thus it 
is unlikely that a POTW will be required to possess an NRC license for 
its sludge. Therefore, a change to 10 CFR 20.2004 regulations is not 
needed.
    If a licensee incinerates licensed material, the staff continues to 
believe that the NRC approval requirements are necessary to have 
reasonable assurance that the public health and safety are adequately 
protected. Hazards associated with incinerating licensed material will 
highly depend on the specific characteristic of the matrix containing 
the licensed material. If a licensee incinerates the licensed material 
contained in the sewage sludge, many factors would have to be 
considered because the sewage sludge could potentially have a broad 
spectrum of radionuclides from various sources and a wide range of 
concentration levels. The potential hazards also highly depend on the 
case-specific incinerator design and site-specific exposure to the 
public and the environment. Even though the discharge requirements for 
10 CFR 20.2003 were set to adequately protect public health and safety 
and the environment, different human exposure scenarios apply to the 
disposal of licensed material by incineration, even if those materials 
are discharged in compliance with another section of the regulations. 
NRC found that the acceptability of incineration as a disposal option, 
except for exempted quantities of radioactive materials, must be 
determined on a facility- and site-specific basis. NRC continues to 
believe that prior NRC approval for incineration is necessary to have 
reasonable assurance that the public health and safety are adequately 
protected. Therefore, NRC is also denying the petitioner's request to 
amend 10 CFR 20.2004 to explicitly exempt radioactive materials that 
enter the sanitary waste stream under 10 CFR 20.2003 from the 
requirements regarding NRC approval for incineration.
    For the reasons cited in this document, NRC denies this petition.

    Dated in Rockville, Maryland, this 21st day of January, 2005.

    For the Nuclear Regulatory Commission.
Annette Vietti-Cook,
Secretary of the Commission.
[FR Doc. 05-1485 Filed 1-26-05; 8:45 am]
BILLING CODE 7590-01-U