Northeast Ohio Regional Sewer District; Denial of Petition for Rulemaking, 3898-3902 [05-1485]
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Proposed Rules
Federal Register
Vol. 70, No. 17
Thursday, January 27, 2005
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.
NUCLEAR REGULATORY
COMMISSION
10 CFR Part 20
[Docket No. PRM–20–22]
Northeast Ohio Regional Sewer
District; Denial of Petition for
Rulemaking
Nuclear Regulatory
Commission.
ACTION: Denial of petition for
rulemaking.
AGENCY:
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
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Electronic Reading Room on the Internet
at https://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 email to pdr@nrc.gov.
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 lwc1@nrc.gov.
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 cobalt60 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
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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
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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
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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
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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
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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 sitespecific 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 (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
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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
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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.
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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,
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‘‘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
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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 NRClicensed 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
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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
VerDate jul<14>2003
08:39 Jan 26, 2005
Jkt 205001
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 sitespecific 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
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 271
[FRL–7864–5]
Georgia: Final Authorization of State
Hazardous Waste Management
Program Revision
Environmental Protection
Agency (EPA).
ACTION: Proposed rule.
AGENCY:
SUMMARY: Georgia has applied to EPA
for Final authorization of the changes to
its hazardous waste program under the
Resource Conservation and Recovery
Act (RCRA). EPA proposes to grant final
authorization to Georgia. In the ‘‘Rules
and Regulations’’ section of this Federal
Register, EPA is authorizing the changes
by an immediate final rule. EPA did not
make a proposal prior to the immediate
final rule because we believe this action
PO 00000
Frm 00005
Fmt 4702
Sfmt 4702
is not controversial and do not expect
comments that oppose it. We have
explained the reasons for this
authorization in the preamble to the
immediate final rule. Unless we get
written comments which oppose this
authorization during the comment
period, the immediate final rule will
become effective on the date it
establishes, and we will not take further
action on this proposal. If we get
comments that oppose this action, we
will withdraw the immediate final rule
and it will not take effect. We will then
respond to public comments in a later
final rule based on this proposal. You
may not have another opportunity for
comment. If you want to comment on
this action, you must do so at this time.
Send your written comments by
February 28, 2005.
DATES:
Send written comments to
Audrey E. Baker, Authorizations
Coordinator, RCRA Programs Branch,
Waste Management Division, U.S.
Environmental Protection Agency, The
Sam Nunn Atlanta Federal Center, 61
Forsyth Street, SW., Atlanta, Georgia
30303–8960; (404) 562–8483. You may
also e-mail comments to
baker.audrey@epa.gov. You can
examine copies of the materials
submitted by Georgia during normal
business hours at the following
locations: EPA Region 4 Library, The
Sam Nunn Atlanta Federal Center, 61
Forsyth Street, SW., Atlanta, Georgia
30303–8960, phone number: (404) 562–
8190, John Wright, Librarian; or The
Georgia Department of Natural
Resources Environmental Protection
Division, 2, Martin Luther King, Jr.,
Drive, Suite 1154 East Tower, Atlanta
Georgia 30334–4910, phone number:
(404) 656–7802.
ADDRESSES:
FOR FURTHER INFORMATION CONTACT:
Audrey E. Baker, Authorizations
Coordinator, RCRA Programs Branch,
Waste Management Division, U.S.
Environmental Protection Agency, The
Sam Nunn Atlanta Federal Center, 61
Forsyth Street, SW., Atlanta, Georgia
30303–8960; (404) 562–8483.
For
additional information, please see the
immediate final rule published in the
‘‘Rules and Regulations’’ section of this
Federal Register.
SUPPLEMENTARY INFORMATION:
Dated: January 6, 2005.
A. Stanley Meiburg,
Deputy Regional Administrator, Region 4.
[FR Doc. 05–1532 Filed 1–26–05; 8:45 am]
BILLING CODE 6560–50–P
E:\FR\FM\27JAP1.SGM
27JAP1
Agencies
[Federal Register Volume 70, Number 17 (Thursday, January 27, 2005)]
[Proposed Rules]
[Pages 3898-3902]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-1485]
========================================================================
Proposed Rules
Federal Register
________________________________________________________________________
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.
========================================================================
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 https://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 pdr@nrc.gov.
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
lwc1@nrc.gov.
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