[Federal Register Volume 60, Number 171 (Tuesday, September 5, 1995)]
[Rules and Regulations]
[Pages 46206-46212]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-21937]




[[Page 46205]]

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Part VI





Environmental Protection Agency





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40 CFR Part 61



National Emission Standards for Radionuclide Emissions From Facilities 
Licensed by the Nuclear Regulatory Commission and Federal Facilities 
not Covered by Subpart H; Final Rule

  Federal Register / Vol. 60, No. 171 / Tuesday, September 5, 1995 / 
Rules and Regulations   

[[Page 46206]]


ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 61

[FRL-5290-8]
RIN 2060-AE38


National Emission Standards for Radionuclide Emissions From 
Facilities Licensed by the Nuclear Regulatory Commission and Federal 
Facilities not Covered by Subpart H

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

SUMMARY: EPA is rescinding subpart I of 40 CFR part 61 as it applies to 
nuclear power reactors, pursuant to section 112(d)(9) of the Clean Air 
Act Amendments of 1990. This section allows EPA to decline to regulate 
Nuclear Regulatory Commission (NRC) licensees if the Administrator 
determines by rule, and in consultation with the NRC, that the 
regulatory program established by the NRC pursuant to the Atomic Energy 
Act provides an ample margin of safety to protect the public health.
    A proposed rule to rescind subpart I as it applies to nuclear power 
reactors was published on August 5, 1991. Based upon the record 
compiled in the subsequent rulemaking, EPA has concluded that the NRC 
regulatory program controlling air emissions of radionuclides from 
nuclear power reactors will assure that the resultant doses will 
consistently and predictably be below the levels which EPA has 
determined are necessary to provide an ample margin of safety to 
protect the public health.

EFFECTIVE DATE: This final rule is effective on September 5, 1995. 
Under section 307(b)(1) of the Clean Air Act (CAA), judicial review of 
this final rule is available only by filing a petition for review in 
the United States Court of Appeals for the District of Columbia Circuit 
within 60 days of the publication of this rule.

FOR FURTHER INFORMATION CONTACT: Fran Jonesi, Risk Assessment and Air 
Standards Branch, Criteria and Standards Division (6602J), Office of 
Radiation and Indoor Air, Environmental Protection Agency, Washington, 
DC 20460, (202) 233-9300.

SUPPLEMENTARY INFORMATION:

Docket

    The rulemaking record is contained in Docket No. A-94-61 (cross-
referenced with A-79-11) and contains all information considered by EPA 
in determining the doses associated with radionuclide emissions from 
NRC-licensed nuclear power reactors. It also contains all comments 
received from the public during the comment period, and a document 
describing the Agency's responses to the comments received. This docket 
is available for public inspection and copying between 8 a.m. and 5 
p.m. on weekdays. A fee may be charged for copying.
    A single copy of a Background Information Document (BID) (EPA/520/
1-89-006-1,2,5,7) containing information on airborne radionuclide 
emissions to the environment from nuclear power reactors has been 
included in the docket. Copies of the BID may also be obtained by 
writing to: Director, Criteria and Standards Division (6602J), Office 
of Radiation and Indoor Air, Environmental Protection Agency, 
Washington, DC 20460.

A. Background

1. Regulatory History

    On October 31, 1989, EPA promulgated National Emission Standards 
for Hazardous Air Pollutants (NESHAPS) under Section 112 of the Clean 
Air Act to control radionuclide emissions to the ambient air from a 
number of different source categories. 54 FR 51654 (December 15, 1989). 
Subpart I of 40 CFR part 61 covers two groups of facilities: (1) 
Facilities licensed and regulated by the Nuclear Regulatory Commission 
(NRC) and its individual Agreement States, and (2) federal facilities 
which are not licensed by the NRC and are not owned or operated by the 
Department of Energy. The first group is quite diverse, and includes 
facilities which have received a license to use or possess nuclear 
materials such as hospitals, medical research facilities, 
radiopharmaceutical manufacturers, laboratories and industrial 
facilities, as well as facilities involved in the uranium fuel cycle 
(the conversion of uranium ore to electric power) such as uranium mills 
(other than radon releases), fuel fabrication plants, and nuclear power 
reactors. It is a subset of the uranium fuel cycle facilities, nuclear 
power reactors, which is the subject of today's action. The second 
group consists of federal facilities such as naval nuclear facilities 
which are not licensed by the NRC and are not affected in any way by 
the proposals to rescind subpart I with respect to NRC licensees.
    Subpart I limits radionuclide emissions to the ambient air to 
amounts which would not cause any member of the public to receive in 
any year an effective dose equivalent (ede) greater than 10 millirem, 
of which no more than 3 millirem ede may be caused by radioiodines.
    When subpart I was originally promulgated in December 1989, EPA 
simultaneously granted reconsideration of subpart I based on 
information received late in the rulemaking on the subject of 
duplicative regulation by NRC and EPA of NRC-licensed facilities and on 
the potential negative effects of the standard on nuclear medicine. EPA 
established a comment period to receive further information on these 
subjects, and granted a 90-day stay of subpart I as permitted by Clean 
Air Act section 307(d)(7)(B), 42 U.S.C. 7607(d)(7)(B). That stay 
expired on March 15, 1990. EPA subsequently extended the stay of the 
effective date of subpart I on several occasions pursuant to the 
authority provided by section 10(d) of the Administrative Procedure 
Act, 5 U.S.C. 705, and section 301(a) of the Clean Air Act, 42 U.S.C. 
7601(a). (See 55 FR 10455, March 21, 1990; 55 FR 29205, July 18, 1990; 
and 55 FR 38057, September 17, 1990). On July 26, 1991, EPA issued a 
final rule staying the effectiveness of subpart I of 40 CFR part 61 for 
NRC-licensed commercial nuclear power reactors pending completion of 
today's rulemaking. See 56 FR 37158 (September 26, 1991), and 40 CFR 
61.109(b).
    EPA also stayed subpart I for NRC and Agreement State licensees 
other than nuclear power reactors while EPA was collecting additional 
information necessary to make a determination under section 112(d)(9) 
of the 1990 Clean Air Act Amendments. See 56 FR 18735 (April 24, 1991), 
and 40 CFR 61.109(a). However, on September 25, 1992, the D.C. Court of 
Appeals issued a decision that EPA had exceeded its authority by 
staying subpart I while EPA was collecting information needed to make a 
determination under section 112(d)(9). Natural Resources Defense 
Council v. Reilly, 976 F.2d 36 (D.C. Cir. 1992). The stay for licensees 
other than nuclear power reactors expired before the NRDC decision 
could be implemented on November 15, 1992, and subpart I took effect 
for these licensees on November 16, 1992.

2. New Authority in the Clean Air Act Amendments

    In November of 1990, Congress enacted amendments to the Clean Air 
Act. Section 112(d)(9) of the Clean Air Act Amendments allows EPA to 
decline to regulate NRC-licensed facilities if the Administrator 
determines, by rule, and after consultation with the Nuclear Regulatory 
Commission, that the 

[[Page 46207]]
regulatory program established by the Nuclear Regulatory Commission 
pursuant to the Atomic Energy Act for such category or subcategory 
provides an ample margin of safety to protect the public health.
    The legislative history of section 112(d)(9) indicates the manner 
in which Congress intended that EPA interpret the phrase ``an ample 
margin of safety to protect the public health'' when making the finding 
required by section 112(d)(9). The Conference Report indicates that the 
``ample margin of safety'' the Administrator must find under section 
112(d)(9) is the same ``ample margin of safety'' that governed the 
development of standards promulgated under section 112 prior to the 
1990 amendments. H.R. Rep. 952, 101st Cong., 2d Sess. 339 (1990). The 
two-step process by which EPA identified an ``ample margin of safety'' 
was described in detail in a U.S. Court of Appeals decision, NRDC v. 
EPA, 824 F.2d 1146 (D.C.Cir 1987) (the Vinyl Chloride decision). The 
1989 NESHAPs standard represents the Agency's application of the Vinyl 
Cloride decision and is consistent with the Agency's approach for 
regulating hazardous air pollutants under section 112 of the Clean Air 
Act.

3. Construction of Section 112(d)(9)

    From the language of section 112(d)(9), it is apparent that where 
EPA has already specifically determined what level of emissions must be 
achieved to provide an ``ample margin of safety,'' that level is the 
benchmark by which EPA must evaluate the adequacy of the NRC program. 
In the present case, EPA specifically found when it promulgated 40 CFR 
part 61, subpart I, that an emission level that would result in a dose 
no greater than 10 mrem/year was necessary to provide the requisite 
``ample margin of safety.'' 54 FR 51654 (December 15, 1989).
    Section 112(d)(9) does not, however, require exact equivalence 
between the EPA and NRC programs applicable to a particular category of 
licensees before EPA may decline to regulate radionuclide emissions 
from that category. Rather, it requires that EPA conclude that 
implementation of the NRC program as a whole will achieve substantive 
protection of the public health equivalent to or better than that which 
would be achieved by enforcement of an EPA standard. Thus, if the NRC 
program as a whole will assure that emissions from all affected 
licensees remain below the EPA standard, the NRC program may be deemed 
to provide an ample margin of safety, regardless of whether this 
results from enforcement by NRC of a single numerical standard.
    In deciding whether EPA may decline to regulate a particular 
category or subcategory of NRC or Agreement State licensees, EPA 
construes section 112(d)(9) as requiring that EPA determine: (1) That 
emissions from NRC licensees (or Agreement State licensees when 
authority to regulate the licensees has been relinquished by NRC) in 
that category or subcategory will be consistently and predictably at or 
below a level resulting in a dose of 10 mrem/year, and (2) that NRC (or 
the Agreement States) can and will require any individual licensee in 
that category or subcategory with emissions that cause a dose exceeding 
10 mrem/year to reduce the emissions sufficiently that the dose will 
not exceed 10 mrem/year.

4. Reconsideration of Subpart I

    After the adoption of section 112(d)(9), EPA reviewed the 
information available to the Agency, including the information provided 
during the Agency's reconsideration of subpart I, to decide whether it 
could determine, for particular categories of licensees, that the NRC 
regulatory program protects public health with an ample margin of 
safety. EPA's initial analysis focused on two general issues: (1) 
Whether the NRC regulatory program in practice results in sufficiently 
low doses to protect the public health with an ample margin of safety; 
and (2) whether the NRC program is sufficiently comprehensive and 
thorough and administered in a manner which will continue to protect 
public health in the future.
a. Nuclear Power Reactors

    During its initial assessment of the NRC program under section 
112(d)(9), EPA concluded that the Agency had sufficient information 
concerning NRC regulation of nuclear power reactors to enable EPA to 
make the requisite finding concerning the adequacy of the NRC program. 
For nuclear power reactors, EPA made a preliminary determination that 
the NRC regulatory program protects public health with an ample margin 
of safety. On March 13, 1991, EPA issued an Advanced Notice of Proposed 
Rulemaking announcing the Agency's intention to enter into a rulemaking 
to rescind subpart I as applied to nuclear power reactors. (56 FR 
10524). This was followed on August 5, 1991 by a Proposed Rule to 
rescind subpart I with respect to nuclear power reactors. (56 FR 
37196).

b. Licensees other than Nuclear Power Reactors

    After reviewing the available information for licensees other than 
nuclear power reactors, EPA concluded that it lacked sufficient 
information concerning actual emissions from these facilities to make 
the substantive determination contemplated by section 112(d)(9). 
Accordingly, EPA undertook an extensive study in order to determine the 
doses resulting from radionuclide emissions at these facilities. EPA 
surveyed a randomly selected subset of all licensed facilities, as well 
as a group of ``targeted'' facilities chosen because of an expectation 
that they would have higher emissions.
    EPA evaluated the results of its study of NRC and Agreement State 
licensees other than nuclear power reactors using the COMPLY computer 
program. None of the facilities evaluated appeared to cause a dose 
exceeding the 10 mrem/year level established by subpart I. When the 
results of the survey were statistically extrapolated to the entire 
population of NRC and Agreement State licensees, EPA concluded that 
virtually all of the facilities would cause doses to members of the 
public which are below 10 mrem/year.
    After reviewing the current NRC regulatory program, and considering 
the likely effect of additional measures which NRC had agreed to adopt 
pursuant to a Memorandum of Understanding, EPA proposed to rescind 
subpart I for NRC and Agreement State licensees other than nuclear 
power reactors on December 1, 1992. See 57 FR 56877 (December 1, 1992). 
However, EPA subsequently identified several concerns regarding the 
Agency's ability to make the substantive finding for these licensees 
required by section 112(d)(9). In particular, EPA was concerned that 
the present NRC program would not assure that radionuclide emissions 
from each such licensee would cause a dose no greater than 10 mrem/
year, and that NRC or the individual Agreement State might not be able 
to require a particular licensee exceeding 10 mrem/year to reduce its 
emissions.
    EPA initiated consultations with the NRC intended to resolve these 
concerns, and EPA and NRC have recently agreed on proposals which, when 
fully implemented, should provide a satisfactory basis for rescission 
of subpart I for NRC and Agreement State licensees other than nuclear 
power reactors. In a forthcoming notice, EPA will reaffirm its proposal 
to rescind subpart I for NRC and Agreement State licensees other than 
nuclear power 

[[Page 46208]]
reactors, describe the revisions to the NRC program which NRC has 
proposed, and provide an additional opportunity for comment concerning 
the sufficiency of the proposed revisions to support the finding 
required by section 112(d)(9).

B. Assessment of the NRC Program Controlling Air Emissions of 
Radionuclides From Nuclear Power Reactors

    In order to determine whether the NRC regulatory program 
controlling air emissions from NRC-licensed commercial nuclear power 
reactors provides an ample margin of safety as required under section 
112(d)(9), EPA has evaluated the doses which result from such emissions 
as well as the specific elements of the NRC program which operate to 
control or limit such emissions. In performing this analysis, EPA has 
focussed on the following questions:
    (1) Do current radionuclide emissions during routine operations of 
nuclear power reactors licensed by NRC result in doses no greater than 
10 mrem/year?
    (2) Will the NRC regulatory program assure that routine 
radionuclide emissions from licensed nuclear power reactors in the 
future result in doses which are consistently and predictably no 
greater than 10 mrem/year?
    (3) If at some point an individual nuclear power reactor has 
routine radionuclide emissions resulting in a dose greater than 10 
mrem/year, will NRC require that the facility in question take actions 
which will reduce emissions to a level resulting in a dose no greater 
than 10 mrem/year?

1. Doses Resulting From Radionuclide Emissions From Nuclear Power 
Reactors

    Of the 100 light-water-cooled commercial nuclear power reactors 
operating in the United States at the time that EPA's analysis was 
conducted, 63 are pressurized water reactors (PWRs) and 37 are boiling 
water reactors (BWRs). These facilities are licensed by the NRC and 
involve operations with the potential for large releases of 
radionuclides.
    During the rulemaking that resulted in the promulgation of the 
final rule in 1989, EPA performed exposure and risk assessments for 
radionuclide releases from Uranium Fuel Cycle (UFC) facilities, a 
category which includes nuclear power reactors. The results of these 
analyses showed that the most exposed individual receives a lifetime 
dose associated with a risk of fatal cancer of 1.5  x  10-4. 
Almost all individuals in the exposed population received a lifetime 
risk of less than 1  x  10-6. These estimated risks are for UFC 
facilities as a whole. For the models used for PWRs and BWRs, the 
values were much lower. The risk to the most exposed individuals were 3 
 x  10-6 and 5  x  10-6 for the model PWR and BWR, 
respectively. The predicted incidences of fatal cancers per year in the 
populations surrounding these model plants were 7  x  10-4 and 1 
x  10-3 for the PWR and BWR, respectively. EPA determined that 
baseline emissions from the UFC category were at a safe level, i.e., 
protected the maximally exposed individual to a lifetime risk level of 
approximately one in ten thousand.
    EPA independently calculated doses for every site with one or more 
operating nuclear power reactor using 1988 emissions data, the most 
recent year for which a complete set of data was available at that 
time. If a plant had below normal emissions in 1988, emissions data for 
a more typical year were used in the analysis. Site-specific data were 
obtained to the maximum extent practical and used as input to the CAP-
88 computer codes. In all cases, the calculated doses to the maximally 
exposed individual did not exceed 1.0 mrem/year ede. This is equivalent 
to a maximum lifetime individual risk of approximately 3 in 100,000. 
Thus, the NRC regulatory program, for the years examined, resulted in 
doses which are at least 10 times lower than the 10 mrem/year ede 
standard established by subpart I.
    EPA also compared the 1988 data with historical data, dating back 
to 1975, to determine if the 1988 data were representative of long term 
trends in population and individual doses. Although the populations 
around the reactor facilities and the facility capacity factors have 
increased over the last fifteen years, EPA determined that the average 
annual collective population doses had steadily declined.
    During the present rulemaking, EPA conducted a review of the 
nuclear power reactor segment of the uranium fuel cycle and determined 
that the individual doses associated with radionuclide emissions from 
nuclear power reactors are even lower than were previously estimated. 
This latest analysis estimates that the most exposed individuals 
receive doses from nuclear power plants of less than 1.0 mrem/year ede 
from all radionuclides and a dose of less than 0.01 mrem/year ede from 
radioiodines. The highest estimated dose in these more recent analyses 
remains at least an order of magnitude below the 10 mrem/year ede 
standard established by subpart I.
    Thus, the evidence clearly demonstrates that current radionuclide 
emissions from nuclear power reactors licensed by NRC result in doses 
no greater than 10 mrem/year. The remaining questions considered by EPA 
require assessment of the elements of the NRC program which control and 
limit air emissions from nuclear power reactors. An assessment of the 
NRC regulatory framework which applies to licensed nuclear power 
reactors follows.

2. The NRC Regulatory Program for Nuclear Power Reactors

    Section 2 of the Atomic Energy Act of 1954 (AEA), as amended, 42 
USC 2012, emphasizes that an important national goal in regulating 
utilization facilities, which would include all nuclear power reactors, 
is protecting the ``health and safety of the public.'' Pursuant to that 
mandate, NRC has an extensive regulatory program covering all facets of 
reactor design, construction, and operation, including regulations 
specifically addressing the release, airborne and otherwise, of 
radionuclides.

a. Regulations Governing Radionuclide Emissions

    There are three regulations which control routine Radionuclide 
emissions from commercial nuclear power plants: (1) 10 CFR part 50, 
Appendix I, ``Numerical Guides for Design Objectives and Limiting 
Conditions for Operation to Meet the Criterion `As Low As is Reasonably 
Achievable' for Radioactive Material in Light-Water-Cooled Nuclear 
Power Reactor Effluents''; (2) 40 CFR part 190, ``Environmental 
Radiation Protection Standards for Nuclear Power Operations''; and (3) 
10 CFR part 20, ``Standards for Protection Against Radiation.''
    10 CFR part 50, Appendix I, provides numerical guides for design 
objectives and limiting conditions for operation to assist licensees in 
meeting the requirements of Secs. 50.34a and 50.36a that radioactive 
material in effluents released to unrestricted areas be kept as low as 
is reasonably achievable (ALARA). The licensee satisfies the design 
objectives, in part, by demonstrating that the gaseous radionuclide 
releases to the atmosphere from each reactor on site will not result in 
an estimated average annual air dose in excess of 10 millirad (absorbed 
dose) for gamma exposure and 20 millirad (absorbed dose) for beta 
exposure. These limits are air doses, resulting from exposure to noble 
gases in unrestricted areas, which could be occupied by an individual. 
Lower radionuclide release rates may be required to satisfy the design 
objectives if it appears that the releases are likely to result in an 

[[Page 46209]]
estimated annual external dose from gaseous effluents, to any 
individual in an unrestricted area, in excess of 5 mrem/year. 
Alternatively, higher release rates may be acceptable if the applicant 
can provide reasonable assurance that the external dose to any 
individual in an unrestricted area, from noble gases, will not exceed 5 
mrem/year to the whole body. [For noble gases, the whole body dose is 
the same as the effective dose equivalent.] The applicant must also 
demonstrate that the calculated annual total quantity of all 
radioiodines and radioactive particulates released to the atmosphere 
from each reactor will not cause exposures to any individual in 
unrestricted areas from all pathways in excess of 15 mrem/year to any 
organ. A dose of 15 mrem/year to the thyroid from radioiodines will 
result in an effective dose equivalent of less than 0.5 mrem/year, as 
the organ weighting factor for calculating the ede for the thyroid is 
0.03. Thus, 10 CFR part 50, Appendix I, limits the total effective dose 
equivalent to approximately 6 mrem/year because essentially all of the 
internal emitters are radioiodines.
    The limiting conditions of operation (LCOs) set forth in Appendix I 
are used to develop technical specifications which are included in the 
facility's license. The technical specifications assure that 
radionuclide releases during operations are consistent with the design 
objectives to maintain off-site doses ALARA. The technical 
specifications are enforceable requirements under NRC's enforcement 
policy (10 CFR part 2, Appendix C).
    40 CFR part 190, ``Environmental Radiation Protection Standards for 
Nuclear Power Operations,'' requires uranium fuel cycle operations to 
be conducted in such a manner that there is reasonable assurance that 
the annual radiation dose equivalent to any member of the public from 
all uranium fuel cycle sources does not exceed 25 mrem to the whole 
body, 75 mrem to the thyroid, and 25 mrem to any other organ. The 
standard applies to gaseous and liquid effluent pathways and direct 
radiation from these facilities.
    In 1981, the NRC amended its regulations to incorporate these 
standards. Sections 20.105(c) and 20.106(g) specifically required 
licensees engaged in uranium fuel cycle operations to comply with the 
40 CFR part 190 dose limits.
    10 CFR part 20, ``Standards for Protection Against Radiation,'' 
consists of standards for protection against radiation hazards arising 
out of activities conducted under licenses issued pursuant to the AEA 
of 1954, as amended. The portions of part 20 that applied to 
radionuclide emissions from licensed facilities were contained in 
Sec. 20.105, which set permissible levels of radiation in unrestricted 
areas, and Sec. 20.106, which established limits on radioactivity in 
effluents to unrestricted areas. On May 21, 1991 (56 FR 23360), major 
revisions to part 20 were published by the NRC, and compliance with the 
revisions became mandatory for all licensees on January 1, 1994. The 
revised rule implements 1987 Presidential guidance on occupational 
radiation protection and the recommendations of scientific 
organizations to establish risk-based limits and a system of dose 
limitation in accordance with the guidance published by the 
International Commission on Radiation Protection. In adopting the risk-
based methodology, the NRC established an explicit dose limit for 
members of the public of 2 mrem/hr not to exceed 100 mrem/year ede, and 
extended an explicit ALARA requirement to all licensees. Doses 
resulting from direct radiation and radionuclides released in gaseous 
and liquid effluents must be evaluated in determining compliance with 
the numerical limits. The revised part 20 also requires licensees to 
comply with the standards set forth in 40 CFR part 190 for the uranium 
fuel cycle (10 CFR 20.1301(d)).
    In addition to these numerical standards, part 20 also requires 
that each licensee make every reasonable effort to maintain radiation 
exposures, and releases of radioactive material in effluents to 
unrestricted areas, to levels which are ALARA (10 CFR 20.1101(b)).
    The principal radionuclides routinely released in the gaseous 
effluents from commercial light-water reactors are noble gases and 
radioiodines. The whole body dose from noble gas emissions per reactor 
is limited by the 5 mrem/year limit of Appendix I. The organ doses from 
radioiodines and particulates are limited to 15 mrem/year. For 
radioiodines, where the thyroid gland is the critical organ, 15 mrem/yr 
effective dose equivalent equates to 0.45 mrem/year. Thus, the total 
ede allowed under Appendix I is even less than 6 mrem/year. The 
guidelines set forth in Appendix I and the standards set forth in 40 
CFR part 190 together establish a regulatory framework that provides a 
high level of assurance that the routine emissions from commercial 
light water reactors will not result in exposures in excess of the EPA 
10 mrem/year ede standard.
b. Monitoring

    Compliance with 10 CFR part 50, Appendix I, and with 40 CFR part 
190 is demonstrated through the establishment of Limiting Conditions of 
Operation (LCOs) and Radiological Effluent Technical Specifications 
(RETS) for each nuclear power reactor in accordance with 10 CFR 50.36a. 
The LCOs and associated RETS require that if the quantity of 
radioactive material actually released in effluents to unrestricted 
areas in any calendar quarter results in radiation exposure, calculated 
on the same basis as the design objectives, exceeding one half the 
annual design objectives, the licensee is required to investigate the 
cause of the release, define and initiate corrective actions to prevent 
a recurrence, and report these actions to the NRC within 30 days from 
the end of the quarter in which the release occurred.
    The LCOs and RETS also require licensees to initiate effluent and 
environmental monitoring programs to provide (1) data on the types and 
quantities of radionuclides released, (2) the levels of radiation and 
radioactive materials in the environment, and (3) changes in land use 
and demography in the vicinity of the site that pertain to compliance 
with the LCOs. If the monitoring data reveal that the relationship 
between the quantities of radioactive materials released and the doses 
to individuals in unrestricted areas is significantly different than 
that assumed in the calculations used to assess compliance with the 
design objectives, the NRC may require a modification of the RETS.
    In order to provide assistance to licensees in complying with the 
LCOS and preparing their RETS, the NRC has issued the following 
guidance: NUREG-0472 and -0473, ``Standard Radiological Effluent 
Technical Specifications for PWRs (and BWRs),'' U.S. NRC, January 1983; 
NUREG-0133, ``Preparation of Radiological Effluent Technical 
Specifications for Nuclear Power Plants,'' U.S. NRC, October 1978; 
NUREG-1301 and NUREG-1302, ``Offsite Dose Calculation Manual Guidance: 
Standard Radiological Effluent Controls for Pressurized Water Reactors 
(and Boiling Water Reactors),'' U.S. NRC, April 1991; and U.S. NRC 
Regulatory Guide 1.21, ``Measuring, Evaluating, and Reporting 
Radioactivity in Solid Waste and Releases of Radioactive Material in 
Liquid and Gaseous Effluents from Light-Water-Cooled Nuclear Power 
Plants''.
    These documents provide highly detailed standard RETS and 
procedures for implementing them. Detailed guidance is provided in the 
areas of effluent monitoring instrumentation; specific equations, 
assumptions and 

[[Page 46210]]
methodologies addressing short- and long-term radioactive releases; and 
the use of gaseous radwaste treatment systems.

c. Inspections

    To ensure that licensees are meeting all regulatory and license-
specific effluent and environmental protection requirements, each 
facility receives approximately 2 radiation protection inspections per 
year by regional NRC inspectors. Along with the plants' reporting 
requirements, the inspections determine the degree to which each plant 
is in compliance with its license and technical specifications, 
including its RETS. If problem areas are identified, follow-up 
inspections are scheduled in order to ensure that deficiencies are 
corrected. If a facility appears to have persistent problems in 
particular areas, the facility is subjected to inspections on a more 
frequent basis.
    The periodic inspections of the RETS include a review of records 
and procedures, interviews with plant personnel, and audits of the 
licensee's effluent and environmental measurements program. The results 
of these analyses not only indicate the level of radioactive material 
in the effluent, but also indicate the degree of accuracy and precision 
of the facility's own effluent monitoring equipment.
    Each operating commercial power plant has at least one full time 
NRC Senior Resident Inspector who provides continuous health and safety 
oversight of plant operations. Sites with multiple reactors have at 
least one Resident Inspector per reactor. If problem areas arise 
pertaining to compliance with the RETS, the Resident Inspector may 
request special inspections and/or audits of related plant operations 
on a more frequent basis.
    All inspections performed by either on-site Resident Inspectors or 
inspectors from the NRC Regional offices or NRC Headquarters are fully 
documented. These reports are made available to the public in the NRC 
Public Document Rooms located in the host community, the regional 
offices, and in Washington, DC. The reports are filed in the separate 
docket established for each reactor site. Reportable licensee events 
include exceeding effluent release rates, worker overexposures, 
procedure violations, and accidents. If detailed event information is 
desired, it can be obtained from the LER filed in the individual 
docket.

C. Summary of Major Comments and EPA Responses

    This section contains a brief description of the major comments 
received relating to the Agency's rescission of 40 CFR part 61, subpart 
I for nuclear power reactors. During the comment period for other 
rulemakings, such as the proposed stays for subpart I, the Agency 
received additional comments on the specific issue of whether to 
rescind subpart I for nuclear power reactors. EPA stated at the time 
that such substantive comments would be addressed at the appropriate 
time following a proposed rule to rescind subpart I. These comments are 
now extensively discussed in the Response to Comments Document which 
has been placed in the docket for public review. The Response to 
Comment document also addresses those comments received during the 60-
day comment period for the subject rulemaking as well as comments 
presented at the September 1991 public hearings held in Washington, DC 
and in Seattle, Washington.
    A major concern expressed by commenters relates to the regulatory 
authority of the states and how action such as this rescission, taken 
pursuant to section 112(d)(9), might affect the states' authority under 
the CAA to establish radionuclide air emission standards. This issue 
was recently addressed in a July 2, 1993 letter from Robert M. Bernero, 
Director of the Office of Nuclear Material Safety and Safeguards to 
Margo Oge, Director of EPA's Office of Radiation and Indoor Air. Mr. 
Bernero states that the NRC's Office of the General Counsel has 
examined the CAA, and relevant portions of the legislative history, 
``and has concluded that the passage of the 1990 CAA amendments had no 
effect on the preexisting power of the States under section 116 to 
establish radionuclide air emission standards, regardless of any action 
EPA might take pursuant to section 112(d)(9).'' EPA concurs with NRC's 
construction. In addition, this issue was extensively discussed by the 
Senate during floor debate for the Clean Air Act Amendments of 1990. 
Passage of the ``Simpson amendment'' failed on the first vote due to 
similar concern that the amendment somehow affected states' rights and 
required resolution before the amendment ultimately succeeded in 
passage. As explained by Senator Burdick, the bill does not affect 
existing states' rights. ``Section 112(d)(9) provides for State 
authority for radionuclide emissions in the same manner and to the same 
extent as does existing section 116'' of the Clean Air Act, which 
contains the provision that ``nothing in this Act shall preclude or 
deny the right of any state or political subdivision thereof to adopt 
or enforce any standard or limitation respecting emissions of air 
pollutants * * *'' April 3, 1990 Congressional Record-page S3798.
    Another significant issue which arose during the comment period 
concerned whether the performance and testing requirements imposed on 
licensees to assure that the regulatory requirements for stack 
emissions monitoring and off-site air monitoring are being met. After 
carefully reviewing NRC's regulatory requirements for airborne effluent 
and environmental monitoring, the Standard Review Plan and Regulatory 
Guides, and the inspection procedures that the NRC uses to assure that 
licensees have installed and are maintaining monitoring systems in 
conformance with the regulatory requirements, EPA concluded that NRC's 
program assured that these factors were being adequately addressed and 
does not preclude EPA's rescission of Subpart I.

D. Final Action

    This final rule rescinding subpart I for commercial nuclear power 
reactors licensed by the NRC is the culmination of the Agency's 
reconsideration of Subpart I for this category of licensees. EPA has 
determined that current radionuclide emissions from NRC-licensed 
nuclear power reactors during routine operations are consistently well 
below levels which would result in doses exceeding 10 mrem/year ede. 
Moreover, EPA has comprehensively evaluated the individual elements of 
the NRC regulatory program which control radionuclide emissions from 
these facilities. Based on this evaluation, EPA has determined that 
radionuclide emissions during routine operations of NRC-licensed 
nuclear power reactors are expected to remain well below levels which 
would result in a dose exceeding 10 mrem/year. EPA has further 
determined that NRC can and will require any licensed nuclear power 
reactor which has radionuclide emissions resulting in a dose exceeding 
10 mrem/year to take specific actions which will reduce emissions to a 
level which results in a dose below 10 mrem/year. Based on these 
determinations, EPA finds under section 112(d)(9) that the NRC 
regulatory program for licensed commercial nuclear power reactors 
provides an ample margin of safety to protect public health.
    This finding with respect to licensed commercial nuclear power 
reactors does not apply to other NRC or Agreement State licensees. 
Although EPA anticipates that the revisions to the NRC program for 
licensees other than nuclear power reactors proposed by NRC as part 

[[Page 46211]]
of recent consultations with EPA will be sufficient to support the 
finding required by section 112(d)(9) for these licensees as well, EPA 
does not intend to conclude the rulemaking concerning rescission of 
Subpart I for these other licensees until NRC has taken final action 
concerning its proposals.
    EPA is prepared to proceed with rescission for nuclear power 
reactors immediately due to several factors which are unique to this 
category of facilities. NRC has established an ALARA guideline for 
nuclear power reactors which equates to approximately 6 mrem/year ede, 
and the individual facilities have consistently committed to achieving 
this level. Measured emissions from nuclear power reactors have also 
been consistently well below this target level.
    In addition, NRC-licensed nuclear power reactors are a relatively 
small, homogeneous and well-characterized group of facilities. EPA 
knows enough about the magnitude of routine emissions from nuclear 
power reactors, the technology utilized to limit such emissions, and 
the administration of the NRC program to control such emissions to 
conclude that NRC will not accept or countenance ALARA emissions from 
these facilities which would result in a dose exceeding 10 mrem/year. 
NRC itself maintains direct oversight of licensed nuclear power 
reactors. In contrast, NRC licensees other than nuclear power reactors 
are a heterogeneous category and consists of a variety of different 
types of facilities. Based on the available database in EPA's 1992 BID, 
about 6,000 licensees are administered by NRC and about 12,000 
licensees are administered by the NRC Agreement States.
    In determining whether the NRC regulatory program for a given 
category of licensees provides an ample margin of safety to protect the 
public health, EPA need not establish exact equivalence between the EPA 
regulatory program under the Clean Air Act and the NRC regulatory 
program. Instead, EPA has examined the enforceable elements in the NRC 
program to determine whether they will assure an equivalent degree of 
protection for public health. EPA is confident that the NRC regulatory 
program for nuclear power reactors provides protection as stringent as 
subpart I, and thereby protects public health with an ample margin of 
safety. Based on this conclusion, EPA is today rescinding 40 CFR part 
61, subpart I, as it applies to NRC-licensed commercial nuclear power 
reactors.
    Today's action is based upon the Agency's determinations concerning 
present emissions from licensed nuclear power reactors, and on the 
Agency's evaluation of the elements of the current NRC regulatory 
program. If the NRC program were to change in the future in a manner 
which permitted radionuclide emissions from routine operations of 
nuclear power reactors to cause doses exceeding 10 mrem/year, EPA would 
consider repromulgating subpart I for such licensees at that time.

D. Judicial Review

    Any petition for judicial review of this final rule must be filed 
in the United States Court of Appeals for the District of Columbia 
within 60 days from the date this rule is published in the Federal 
Register. Only an objection to the rule which was raised with 
reasonable specificity during the period for public comment (including 
public hearings) may be raised as part of any petition for judicial 
review.
E. Miscellaneous

1. Paperwork Reduction Act

    The reporting and record keeping requirements rescinded in today's 
notice were approved by OMB as part of the Information Collection 
Request for the Radionuclide NESHAP, OMB control number 2060-0191. The 
EPA has submitted an Information Correction Worksheet to OMB to delete 
the burden associated with these requirements from that clearance.

2. Executive Order 12866

    Under Executive Order 12866, (58 FR 57735, October 4, 1993) the 
Agency must determine whether this regulation, if promulgated, is 
``significant'' and therefore subject to OMB review and the 
requirements of the Executive Order. The Order defines ``significant 
regulatory action'' as one that is likely to result in a rule that may:
    (1) Have an annual effect on the economy of $100 million or more or 
adversely affect in a material way the economy, a sector of the 
economy, productivity, competition, jobs, the environment, public 
health or safety, or State, local or tribal governments or communities;
    (2) Create a serious inconsistency or otherwise interfere with an 
action taken or planned by another agency;
    (3) Materially alter the budgetary impact of entitlements, grants, 
user fees, or loan programs or the rights and obligations of recipients 
thereof; or
    (4) Raise novel legal or policy issues arising out of legal 
mandates, the President's priorities, or the principles set forth in 
the Executive Order.
    This action will not result in an annual effect on the economy of 
$100 million or another adverse economic impact, does not create a 
serious inconsistency or interfere with another agency's action, and 
does not materially alter the budgetary impacts of entitlements, 
grants, user fees, etc. However, EPA has concluded that this action may 
be construed as raising novel legal or policy issues. Accordingly, EPA 
has submitted this action to OMB and has obtained the requisite 
approval under the terms of Executive Order 12866.

3. Regulatory Flexibility Analysis

    Section 603 of the Regulatory Flexibility Act, 5 U.S.C. 603, 
requires EPA to prepare and make available for comment an ``initial 
regulatory flexibility analysis'' in connection with any rulemaking for 
which there is a statutory requirement that a general notice of 
proposed rulemaking be published. The ``initial regulatory flexibility 
analysis'' describes the effect of the proposed rule on small business 
entities. However, section 605(b) of the Act provides that an analysis 
not be required when the head of an Agency certifies that the rule will 
not, if promulgated, have a significant impact on a substantial number 
of small entities.
    It was found in the 1989 rule for 40 CFR part 61, subpart I, that 
there was no significant impact on small business entities. There has 
been no change in this finding. Because the changes ease the regulatory 
burdens associated with provisions of the existing final rule, EPA 
believes that this rule will have no adverse effect on small 
businesses. For the preceding reason, I certify that this rule will not 
have significant economic impact on a substantial number of small 
entities.

List of Subjects in 40 CFR Part 61

    Air pollution control, Arsenic, Asbestos, Benzene, Beryllium, 
Hazardous materials, Mercury, Radionuclides, Vinyl Chloride.

    Dated: August 28, 1995.
Carol M. Browner,
Administrator.

    Part 61 of chapter I of title 40 of the Code of Federal Regulations 
is amended as follows:

PART 61--[AMENDED]

    1. The authority citation for part 61 continues to read as follows:

    Authority: 42 U.S.C. 7401, 7412, 7414, 7416, 7601.

    2. Section 61.100 is revised to read as follows: 

[[Page 46212]]



Sec. 61.100  Applicability.

    The provisions of this subpart apply to facilities other than 
nuclear power reactors which are licensed by the Nuclear Regulatory 
Commission. This subpart also applies to facilities owned or operated 
by any Federal agency other than the Department of Energy, except that 
this subpart does not apply to disposal at facilities regulated under 
40 CFR part 191, subpart B, or to any uranium mill tailings pile after 
it has been disposed of under 40 CFR part 192, or to low energy 
accelerators, or to any NRC-licensee that possesses and uses 
radionuclides only in the form of sealed sources.


Sec. 61.107  [Amended]

    3. Section 61.107 is amended by removing paragraph (c)(1) and by 
redesignating paragraphs (c)(2) and (3) as (c)(1) and (2).


Sec. 61.109  [Removed]

    4. Section 61.109 is removed.

[FR Doc. 95-21937 Filed 9-1-95; 8:45 am]
BILLING CODE 6560-50-P