[Federal Register Volume 61, Number 251 (Monday, December 30, 1996)]
[Rules and Regulations]
[Pages 68972-68981]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-32977]
[[Page 68971]]
_______________________________________________________________________
Part VI
Environmental Protection Agency
_______________________________________________________________________
40 CFR Part 61
National Emissions 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. 61, N0. 251 / Monday, December 30, 1996 /
Rules and Regulations
[[Page 68972]]
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 61
[FRL-5670-5]
RIN 2060-AE 39
National Emissions 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.
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SUMMARY: EPA is rescinding 40 CFR part 61, subpart I (subpart I) as it
applies to Nuclear Regulatory Commission (NRC) or NRC Agreement State
licensed facilities other than commercial nuclear power reactors.
Subpart I is a National Emission Standard for Hazardous Air Pollutants
(NESHAPs) which was published on December 15, 1989 and which limits
radionuclide emissions to the ambient air from NRC-licensed facilities.
As required by section 112(d)(9) of the Clean Air Act as amended in
1990, EPA has determined that the NRC regulatory program for licensed
facilities other than commercial nuclear power reactors protects public
health with an ample margin of safety, the same level of protection
that would be afforded by continued implementation of subpart I.
DATES: This rule is effective December 30, 1996. Under section
307(b)(1) of the Clean Air Act, judicial review of this final action is
available only by filing a petition for review in the United States
Court of Appeals for the District of Columbia Circuit no later than
February 28, 1997.
FOR FURTHER INFORMATION CONTACT: Gale Bonanno, Center for Federal
Guidance and Air Standards and Communications, Radiation Protection
Division, 6602J, Office of Radiation and Indoor Air, Environmental
Protection Agency, Washington, DC 20460 (202) 233-9219, or Eleanor
Thornton, at the same address (202) 233-9773.
SUPPLEMENTARY INFORMATION:
Regulated Entities
Entities affected by this action include facilities, other than
commercial nuclear power generators, licensed by the Nuclear Regulatory
Commission (NRC) or an NRC Agreement State. Subpart I continues to
apply to federal facilities not owned or operated by the Department of
Energy (DOE) (``non-DOE'' federal facilities) and not licensed by the
NRC. Facilities owned or operated by the Department of Energy are
regulated under 40 CFR part 61 subpart H. The Agency notes that
radionuclide NESHAPs subparts other than subpart I continue to apply as
stated in each regulation to the owners and operators of uranium mill
tailings piles, e.g., 40 CFR part 61 subpart W. This action does not
affect regulation of radionuclides under statutes other than the CAA,
e.g. Comprehensive Environmental Response, Compensation and Liability
Act of 1980 (42 U.S.C. 9601).
Affected categories and entities include:
------------------------------------------------------------------------
Category Examples of facilities
------------------------------------------------------------------------
NRC-Licensees............................ Uranium fuel cycle (those
engaged in the conversion
of uranium ore to produce
electric power, e.g.,
uranium mills, fuel
fabrication plants).
Facilities licensed to use
or possess nuclear
materials such as
hospitals, medical research
facilities,
radiopharmaceutical
manufacturers,
laboratories, etc.
------------------------------------------------------------------------
This table is not intended to be exhaustive, but rather provides a
guide for readers regarding entities likely to be affected by this
action. This table lists the types of entities that EPA is now aware
could potentially be affected by this action. Other types of facilities
not listed in the table could also be regulated. To determine whether
your facility is regulated by this action, you should carefully examine
the applicability criteria in Sec. 1.100 of today's rule which amends
part 61 of Title 40 of the Code of Federal Regulations. If you have
questions regarding the applicability of this action to a particular
facility, consult the persons listed in the preceding FOR FURTHER
INFORMATION CONTACT section.
Docket
Docket A-92-50 (cross-referenced with Dockets A-79-11 & A-92-31)
contains the rulemaking record. The docket is available for public
inspection between the hours of 8 A.M. and 5:30 P.M., Monday through
Friday, in room M1500 of Waterside Mall, 401 M Street, SW, Washington,
DC 20460. A reasonable fee may be charged for copying. The fax number
is 202-260-4400.
Table of Contents
I. Background
A. Regulatory History
B. Clean Air Act Amendments of 1990
C. Reconsideration of Subpart I
II. Rationale for Final Rule to Rescind 40 CFR Part 61, Subpart I
for NRC and Agreement State Licensees
A. 1992 Proposal to Rescind Subpart I for Licensees Other Than
Nuclear Power Reactors
1. EPA Study of Emissions From NRC-Licensed Facilities
2. Memorandum of Understanding (MOU) Between EPA and NRC
B. Events Subsequent to the 1992 Proposal
1. Changes to NRC Regulatory Program After the 1992 Proposal
2. EPA Concerns Regarding Basis for Required Statutory Finding
Under Section 112(d)(9)
3. NRC Actions Responsive to EPA Concerns
4. EPA's Notice Reopening Comment Period
5. NRC Constraint Level for Air Emissions of Radionuclides and
NRC Agreement State Policies and Procedures
III. Final Rule to Rescind 40 CFR Part 61, Subpart I for NRC and
Agreement State Licensees
A. EPA Determination Under CAA Section 112(d)(9)
IV. Summary of Major Comments and Responses to Comments from 1992
NPRM and Notice Reopening Comment Period
V. Judicial Review
VI. Miscellaneous
A. Paperwork Reduction Act
B. Executive Order 12866
C. Submission to Congress and the General Accounting Office
D. Regulatory Flexibility Analysis
E. Unfunded Mandates Reform Act
I. Background
A. 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 individual Agreement States (``NRC licensed facilities''),
and (2) federal facilities which are not licensed by the NRC and are
not owned or operated by the Department of Energy (``non-DOE federal
facilities''). The first group is 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
[[Page 68973]]
uranium mills and fuel fabrication plants. EPA estimates there are
approximately 22,000 such NRC and Agreement State licensed facilities
in the United States (this figure includes those facilities using only
sealed sources).
The present rulemaking concerns all NRC licensed facilities other
than commercial nuclear power reactors, which are the subject of a
separate rulemaking (60 FR 46206, Sept. 5, 1995). Non-DOE federal
facilities not licensed by the NRC are not affected in any way by the
present rulemaking. Subpart I limits radionuclide emissions from NRC
licensed facilities to the ambient air to that amount which would cause
any member of the public to receive in any year an effective dose
equivalent (ede) no greater than 10 millirem (mrem), of which no more
than 3 mrem ede may be from radioiodine. These limits were established
pursuant to an EPA policy for section 112 pollutants first announced in
the benzene NESHAP (54 FR 38044, September 14, 1989), utilizing the
two-step process outlined in the vinyl chloride decision. Natural
Resources Defense Council v. EPA, 824 F.2d 1146, (D.C. Cir. 1987)(Vinyl
Chloride).
When subpart I was originally promulgated in December 1989, EPA
simultaneously granted reconsideration of the subpart 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 (CAA) section 307(d)(7)(B), 42 U.S.C. 7607 (d) (7)(B). That
stay expired on March 15, 1990, and was subsequently extended on
several occasions. (See 55 FR 10455, March 21, 1990; 55 FR 29205, July
18, 1990; and 55 FR 38057, September 17, 1990).
EPA later stayed subpart I for NRC and Agreement State licensees
other than nuclear power reactors while EPA was collecting the
additional information necessary to make a determination under section
112(d)(9) of the 1990 CAA Amendments. See 56 FR 18735 (April 24, 1991),
and 40 CFR 61.109(a). However, on September 25, 1992, the U.S. Court of
Appeals for the DC Circuit issued a decision that EPA had exceeded its
authority by staying subpart I while the Agency 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)(NRDC). 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. EPA subsequently issued a notice confirming the effectiveness of
subpart I for licensees other than nuclear power reactors. See 59 FR
4228 (January 28, 1994).
B. Clean Air Act Amendments of 1990
In 1990, Congress enacted legislation comprehensively amending the
CAA, which included a section addressing the issue of regulatory
duplication between EPA and NRC. CAA section 112(d)(9) provides that,
``[N]o standard for radionuclide emissions from any category or
subcategory of facilities licensed by the Nuclear Regulatory Commission
(or an Agreement State) is required to be promulgated under [section
112] if the Administrator determines, by rule, and after consultation
with the Nuclear Regulatory Commission, that the 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.'' This provision enables EPA to
eliminate duplication of effort between EPA and NRC in instances where
EPA can determine that the NRC program provides protection of public
health equivalent to that required by the CAA.
C. 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 NRC 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.
After reviewing the available information for licensees other than
nuclear power reactors, EPA concluded that it lacked sufficient
information concerning actual air 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 facilities other than
nuclear power reactors. As discussed in detail in section II.A.1, 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 air emissions. See Draft Background
Information Document, ``NESHAPs Rulemaking on Nuclear Regulatory
Commission and Agreement State Licensees Other Than Nuclear Power
Reactors'' EPA-430-R-92-011 (November 1992), Docket Entry A-92-50, II-
B-1.
After evaluating the results of its study, reviewing the then
current NRC regulatory program, and considering the likely effect of
revisions of the NRC program which were pending at that time and of
additional measures which NRC had agreed to adopt pursuant to a
Memorandum of Understanding (MOU) with EPA (see section II.A.2), 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).
II. Rationale for Final Rule to Rescind 40 CFR Part 61, Subpart I
for NRC and Agreement State Licensees
A. 1992 Proposal to Rescind Subpart I for Licensees Other Than Nuclear
Power Reactors
The 1992 proposal to rescind subpart I for NRC licensees other
than nuclear power reactors was based on EPA's extensive study of those
licensees and on commitments made by NRC in an MOU with EPA. See 57 FR
56877 (December 1, 1992).
1. EPA Study of Air Emissions From NRC Licensed Facilities
In order to determine whether NRC licensees other than nuclear
power reactors were in compliance with those emission limits deemed
necessary by EPA to protect public health, EPA undertook a
comprehensive study to determine the doses that resulted from emissions
from these facilities. See Draft Background Information Document,
``NESHAPs Rulemaking on Nuclear Regulatory Commission and Agreement
State Licensees Other Than Nuclear Power Reactors'' EPA-430-R-92-011
(November 1992), Docket Entry A-92-50, II-B-1. A major component of
this study was a survey and analysis of a randomly selected subset of
the approximately 6,000 NRC and Agreement State licensees using
unsealed sources. These consist of hospitals, radiopharma-
[[Page 68974]]
ceutical manufacturers and distributors, and laboratories for which the
doses and other emissions data were not well characterized. In order to
gather the necessary information, EPA sent a letter under the authority
of section 114 of the CAA to the selected facilities requiring them to
submit specific information concerning their emissions and proximity to
the exposed population. Doses were then determined by EPA using the
COMPLY computer program which was specified in subpart I for
determining compliance with the standard. EPA also investigated a group
of ``targeted'' facilities selected for their potential to cause high
doses.
EPA obtained Office of Management and Budget approval to send
questionnaires to as many as 670 of the approximately 6,000 facilities,
requesting release rates and the other necessary parameters. Since
facilities handling only sealed sources do not present the potential
for airborne emissions, they had been exempted from the NESHAP and were
also excluded from analysis in the EPA study. Because EPA could not
accurately determine in advance whether a given NRC or Agreement State
licensee handled only sealed sources and would therefore be excluded
from the analysis, the Agency over sampled in order to obtain the
required number of responses.
A sample of at least 300 facilities was needed in order to be 95
percent confident that EPA could establish a dose level below which the
doses caused by air emissions from 99 percent of the facilities lie.
Over 600 letters were sent to a random subset of NRC or Agreement State
licensees. Responses were submitted by all but three facilities and 367
of the responses were determined to be from facilities using unsealed
sources.
The COMPLY computer program was used to estimate doses to the most
exposed individuals located near the facilities. The National Oceanic
and Atmospheric Administration's data base was used for meteorological
data for the sites. Many facilities were contacted to obtain
clarification or site-specific information. The dose to the nearest
resident to each facility was calculated from the facility-specific
information taken from the questionnaire and using meteorological data
from the closest weather station.
A second component of the study was the targeted facilities, which
fell into three sub-groups: (a) facilities determined to have potential
for large emissions and which were not fully characterized in previous
evaluations (examples included research reactors, rare earth producers,
waste incinerators, low level waste facilities, and large university
hospitals); (b) facilities with potential for large emissions which
were more adequately characterized in previous assessments (these
included fuel cycle facilities such as uranium mills, fuel fabrication
plants, UF6 conversion plants); (c) atypical activities for which no
formal evaluations had been made (these included activities such as
depleted uranium weapons testing).
For facilities in sub-group (a), the data needed to characterize
the emissions and doses were obtained from existing NRC docket
information, supplemented as necessary with requests for missing data
under authority of CAA section 114. The results of the previous
assessments for facilities in sub-group (b) were summarized and updated
to include more recent information. For the third sub-group, EPA
reviewed the activity in question to ascertain the potential for
significant airborne emissions, and evaluated the doses for these
activities found to involve potentially significant emissions.
After evaluating both the randomly surveyed 367 facilities and the
specifically targeted facilities using the COMPLY computer program, EPA
determined that the highest estimated dose received by any member of
the public from airborne emissions of radionuclides from any facility
was 8.0 mrem/yr ede. Thus, none of the facilities evaluated appeared to
cause a dose exceeding the levels established by the Administrator in
the radionuclides NESHAPs. The median dose for the population is
0.00069 mrem/yr. See Draft Background Information Document, ``NESHAPs
Rulemaking on Nuclear Regulatory Licensees Other Than Nuclear Power
Reactors'' EPA 430-R-92-011 (November 1992), Docket Entry A-92-50, II-
B-1 at 4-11. When the results of the survey were statistically
extrapolated to the entire population of NRC or Agreement State
licensees, EPA concluded that emissions from virtually all of the
facilities were expected to be below the limits established by EPA.
After evaluating the results of the study, EPA concluded that current
emissions by NRC and Agreement State licensees other than nuclear power
reactors result in doses less than the level found by EPA to provide an
ample margin of safety to protect the public health.
2. Memorandum of Understanding (MOU) Between EPA and NRC
In an MOU executed on September 4, 1992, NRC committed to take
several actions to implement ``As Low As Reasonably Achievable''
(ALARA) requirements for NRC licensees other than nuclear power
reactors. This MOU was published on December 22, 1992, at 57 FR 60778.
Although the NRC regulatory program included mandatory dose limits
that were higher than those established by subpart I, EPA's study
demonstrated that the actual operation of the existing NRC program had
resulted in lower doses to the public than those which would be allowed
under subpart I. The steps established by the MOU reflected an
expectation by EPA that new mandatory ALARA requirements would operate
to constrain future increases in radionuclide emissions by NRC
licensees which might otherwise be permissible under the NRC program.
Under the provisions of the MOU, NRC agreed to develop and issue a
regulatory guide on the design and implementation of a radiation
protection program to ensure that doses resulting from effluents from
licensed facilities would remain ALARA. See section II.B.2 below. NRC
agreed that the guide would describe the types of administrative
programs and objectives which would be considered acceptable in
satisfying the requirements of 10 CFR 20.1101(b), and establish a
specific design goal of 10 mrem/yr ede to the maximally exposed
individual for radionuclide air emissions from affected NRC and
Agreement State licensees. See NRC Regulatory Guide 8.37, ``ALARA
Levels for Effluents from Materials Facilities,'' July 1993, Docket
Entry A-92-50, II-F-4.
B. Events Subsequent to the 1992 Proposal
1. Changes to NRC Regulatory Program After the 1992 Proposal
After EPA published its 1992 proposal to rescind subpart I, major
revisions to NRC's regulations at 10 CFR Part 20 became effective.
NRC's revised rule (effective January 1994) 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
(ICRP). In adopting the risk-based methodology, the NRC reduced the
allowable dose limit for members of the public from 500 mrem/yr ede to
100 mrem/yr ede from all pathways, which is then subject to further
reduction under the ALARA provisions. Of the 100 mrem/yr ede, NRC
allows only 50 mrem/yr ede by the air pathway, according to their
Derived
[[Page 68975]]
Air Concentration tables, which is then subject to further reduction
under the ALARA provisions.
Another significant revision of Part 20 codified the ALARA
principle, which previously was only general guidance for NRC licensees
other than nuclear power reactors. All licensees must now conduct
operations in a manner that keeps doses to both workers and members of
the public ALARA. This is defined to mean:
making every reasonable effort to maintain exposures to radiation as
far below the dose limits in this part as is practical consistent
with the purpose for which the licensed activity is undertaken,
taking into account the state of technology, the economics of
improvements in relation to state of technology, the economics of
improvements in relation to benefits to the public health and
safety, and other societal and socioeconomic considerations, and in
relation to utilization of nuclear energy and licensed materials in
the public interest.
10 CFR 20.1003. 56 FR 23360, 23392 (May 21, 1991).
2. EPA Concerns Regarding Basis for Required Statutory Finding Under
Section 112(d)(9)
Based on the record compiled as part of its proposal to rescind
subpart I for NRC licensees other than nuclear power reactors, EPA was
able to conclude that the vast majority of NRC and Agreement State
licensees were in compliance with the 10 mrem/yr standard established
by subpart I. However, after reviewing the language of the final
Regulatory Guide issued by NRC pursuant to the September 4, 1992 MOU,
EPA concluded that there was no element in the NRC regulatory program
which expressly required or assured that licensees other than nuclear
power reactors would maintain air emissions of radionuclides below
EPA's 10 mrem/yr standard. See NRC Regulatory Guide 8.37, ``ALARA
Levels for Effluents from Materials Facilities,'' July 1993, Docket
Entry A-92-50, II-F-4. Thus, it was not possible for the Agency to
determine that radionuclide emissions to the ambient air would
consistently and predictably remain below the EPA standard in the
future if EPA were to proceed with rescission, or that NRC or the
individual Agreement States would be in a position to require a
particular licensee who did exceed 10 mrem/yr to reduce radionuclide
emissions.
Another concern regarding the adequacy of the NRC program to
support rescission of subpart I for licensees other than nuclear power
reactors arose as part of an investigation by the General Accounting
Office (GAO) of NRC's administration of its Agreement State program.
Licenses for facilities other than nuclear power reactors are often
administered by individual Agreement States rather than by NRC. In a
report entitled ``Nuclear Regulation: Better Criteria and Data Would
Help Ensure Safety of Nuclear Materials,'' the GAO found that ``NRC
lacks criteria and data to evaluate the effectiveness of its two
materials programs [agreement and non-agreement state],'' and that
``For agreement-state programs, NRC does not have specific criteria or
procedures to determine when to suspend or revoke an inadequate or
incompatible program.'' GAO/RCED-93-90 Nuclear Materials Regulation at
3 (April 1993). In subsequent Congressional testimony concerning the
GAO findings, the NRC Commissioners acknowledged that NRC criteria and
procedures should be improved, and stated that NRC was developing new
criteria to assess the adequacy and compatibility of individual
Agreement State programs, and new procedures which would govern
suspension and termination of Agreement State programs.
As contemplated by CAA section 112(d)(9), EPA and NRC entered into
consultations intended to resolve these concerns. The ALARA program,
which requires NRC licensees to reduce emissions to the extent feasible
below the mandatory ceiling in 10 CFR Part 20, was the principal focus
of subsequent discussions between EPA and NRC. In these discussions,
EPA and NRC discussed various NRC proposals for a rule which would
``constrain'' emissions from NRC licensees other than nuclear power
reactors, either by establishing a rebuttable presumption that
emissions causing a dose exceeding 10 mrem/yr are not ALARA, or by
expressly finding that ALARA requires licensees to maintain emissions
at or below the 10 mrem/yr level. During the course of these
discussions, a new concern also emerged as to whether the NRC policies
on Agreement States which were under development would enable NRC to
require that a ``constraint level'' be a mandatory element of
compatibility. See letter from Mary D. Nichols, EPA Assistant
Administrator for Air and Radiation, to NRC Chairman Ivan Selin, July
6, 1994, Docket Entry A-92-50, IV-C-4.
On July 22, 1994, NRC proposed a ``constraint level'' rule which
would have required each licensee to develop an ALARA program to
maintain or achieve emissions resulting in a dose at or below 10 mrem/
yr or, in the alternative, to ``justify'' a conclusion that emissions
resulting in a dose exceeding 10 mrem/yr are ALARA. See letter from NRC
Chairman Ivan Selin to EPA Administrator Carol M. Browner, July 22,
1994, Docket Entry A-92-50, IV-D-74. That correspondence also noted
that new procedures to assure the adequacy and compatibility of
Agreement States were under development, and indicated that NRC would
also propose to require Agreement States to adopt the proposed
``constraint level'' rule as a matter of compatibility.
After reviewing the ``constraint level'' rule proposed by NRC on
July 22, 1994, EPA concluded that the proposed provision permitting
licensees to ``justify'' emissions in excess of 10 mrem/yr left
uncertainty as to whether NRC or an individual Agreement State might
accept or countenance as ALARA emissions resulting in a dose exceeding
10 mrem/year. As a consequence, EPA was concerned that it would still
not be able to determine that future radionuclide emissions from
affected licensees would be consistently and predictably at levels
resulting in a dose below 10 mrem/yr, or that NRC or an individual
Agreement State would be able to compel a licensee to reduce emissions
if the 10 mrem/yr level were exceeded. EPA then advised NRC that EPA
did not consider it prudent to proceed with rescission of subpart I for
NRC licensees other than nuclear power reactors based on a record which
might not adequately support the legal determination required by
section 112(d)(9). Docket Entry A-92-50, IV-C-4.
3. NRC Actions Responsive to EPA Concerns
On December 21, 1994, after further considering the concerns
expressed by EPA, NRC proposed to EPA a ``constraint'' rule construing
ALARA as requiring each licensee to limit air emissions to a level
resulting in a dose no greater than 10 mrem/yr. See letter from NRC
Chairman Ivan Selin to EPA Administrator Carol M. Browner, December 21,
1994, Docket Entry A-92-50, IV-D-26. Under this proposal, exceeding the
NRC constraint level would not itself be a violation, but any licensee
exceeding the 10 mrem/yr constraint would be required to report the
exceedance and to take corrective measures to prevent a recurrence. On
March 14, 1995, NRC confirmed that it intended to make the proposed
constraint rule a matter of Division Level 2 compatibility, which
requires each Agreement State to incorporate in its program provisions
at least as stringent as those established by the NRC rule. See letter
from Robert M. Bernero, Director of the NRC Office Of
[[Page 68976]]
Nuclear Material Safety and Safeguards, to Mary D. Nichols, EPA
Assistant Administrator for Air and Radiation, March 14, 1995, Docket
Entry A-92-50, IV-D-27.
NRC has also taken steps which address concerns regarding the
adequacy of criteria and procedures for the Agreement State program.
NRC published a draft policy statement concerning adequacy and
compatibility criteria, 59 FR 37269 (July 21, 1994), and a draft policy
statement setting forth procedures which permit suspension or
termination of individual Agreement State programs. 59 FR 40059 (August
5, 1994). In the March 14, 1995 letter, NRC assured EPA that the final
policy statement on compatibility criteria would be consistent with the
NRC proposal to make the NRC ``constraint level'' rule a matter of
Division Level 2 compatibility.
After reviewing the proposed rule described in the December 21,
1994 letter and the additional assurances provided in the March 14,
1995 letter, EPA advised NRC that it had concluded that adoption by NRC
of the proposals and policies set forth in these letters should be
sufficient to resolve the Agency's stated concerns regarding its
ability to make the finding required to support rescission under CAA
Section 112(d)(9). See letter from EPA Administrator Carol M. Browner
to NRC Chairman Ivan Selin, March 31, 1995, Docket Entry A-92-50, IV-C-
5. In that correspondence, EPA also stated its intent to publish a
notice requesting supplementary comment concerning the proposed rule to
rescind subpart I for NRC licensees other than nuclear power reactors
in conjunction with the publication by NRC of its proposed constraint
rule.
4. EPA's Notice Reopening the Comment Period
EPA published a notice reopening the comment period for the
rulemaking to rescind subpart I. 60 FR 50161, (September 28, 1995). The
Notice reaffirmed EPA's proposal to rescind subpart I, described the
expected proposed revisions to the NRC program which would support
EPA's rescission, and invited additional comment on the sufficiency of
the revisions to the NRC program to support the finding required by
section 112(d)(9). The Agency extended the period for submitting
comments in response to the Notice until February 22, 1996, to allow
the public time to review NRC's proposed constraint rule prior to
submitting comments to EPA. NRC published the proposed constraint rule
on December 13, 1995. 60 FR 63984.
5. NRC Constraint Level for Air Emissions of Radionuclides and NRC
Agreement State Policies and Procedures
On December 10, 1996, Commissioners adopted a final ``constraint''
rule modifying the NRC radiation protection program codified at 10 CFR
part 20. 61 FR 65120. The final regulations adopted by NRC establish a
constraint of 10 mrem/yr total effective dose equivalent (TEDE) 1
for dose to members of the public from air emissions of radionuclides
from NRC licensed facilities other than commercial nuclear power
reactors. 10 CFR section 20.1101(d). A dose constraint is defined as
``a value above which specified licensee actions are required.'' 10 CFR
section 20.1003, as amended. Thus, the final rule codifies a numerical
value, 10 mrem/yr TEDE, for NRC's application of its ALARA principles
contained in 10 CFR part 20 for radioactive air emissions from NRC
licensees other than commercial nuclear power reactors. In the event
that the 10 mrem/yr constraint is exceeded, the exceedance must be
reported to NRC by the licensee within 30 days and the licensee must
also provide a description of the circumstances of the exceedance and
describe the corrective steps that have been or will be taken to ensure
that the exceedance will not reoccur. 10 CFR section 20.2203(b)(l)(iv);
61 FR at 65121. NRC regulations provide for licensees to propose
corrective steps and NRC will approve such actions (e.g., installation
of filters, installation of a new pump, etc.) if appropriate to
effectuate a decrease in dose. 10 CFR section 20.1101(d); 61 FR at
65123. See also Memorandum to Docket A-92-50 from Gale Bonanno,
Workgroup Chair, December 16, 1996, Docket Entry A-92-50, IV-B-1
(analyzing final ``constraint'' rule).
---------------------------------------------------------------------------
\1\ NRC expresses dose in total effective dose equivalent
(TEDE), while subpart I expresses dose in effective dose equivalent
(EDE). These two terms are equivalent.
---------------------------------------------------------------------------
The final constraint rule has been assigned a Division Level 2
compatibility. 61 FR at 65126. Thus, the Agreement States must address
the constraint rule in their regulations, but they may adopt more
restrictive requirements than the constraint rule. The Commission plans
to revise and finalize draft NRC Regulatory Guide 8.37 as Regulatory
Guide 4.20 at the time of implementation of their rule. This Regulatory
Guide will outline methods for demonstrating compliance with the
constraint level and the elements of the report required to be
submitted in the event the constraint level is exceeded. This Guide
will also express the Commission's belief that based on EPA's study and
NRC's ongoing licensing and inspection program, the constraint level
for doses to members of the public from air emissions of radionuclides
as codified at section 20.1101(d) is easily achievable by all materials
licensees.
In addition, the Commission recently approved, in principle, final
policy statements entitled ``Statement of Principles and Policy for the
Agreement State Program'' and ``Policy Statement on Adequacy and
Compatibility of Agreement State Programs''. 60 FR 39463 (August 2,
1995). These documents describe the principles of the Agreement State
program including the roles and responsibilities of NRC and the States
in administering the program, and outline a general framework for
determining which NRC program elements and requirements should be
implemented by the Agreement States.
NRC provided additional information to EPA regarding the
Commission's authority to suspend or terminate Agreement State
programs. See letter from Martin Malsch, NRC Deputy General Counsel to
Ramona Trovato, Director of EPA's Office of Radiation and Indoor Air,
November 19, 1996, Docket Entry A-92-50, IV-G-8. As discussed above,
the Commissioners approved the final ``constraint'' rule as a matter of
Division 2 compatibility, meaning that Agreement States ``will have to
include an essentially identical or more restrictive legally binding
generic requirement in their regulatory program.'' Id. The
correspondence notes that in the event an Agreement State adopts a
standard which is less stringent than the constraint rule, ``NRC would
be legally authorized to take a variety of actions with respect to the
State program, including probation, suspension or termination of the
program.'' Id.
Moreover, periodic reviews of the Agreement State programs are
conducted by NRC to ensure that those programs are compatible with
NRC's regulatory program and adequate to protect the public health. Id.
The review process and criteria for such reviews are contained in NRC's
Integrated Materials Performance Evaluation Program (IMPEP) issued on
September 12, 1995, a copy of which is contained in the docket for this
rulemaking. As noted in the correspondence, procedures were provided to
the Commissioners on April 25, 1996, which will be applied by NRC if
circumstances warrant the future suspension or termination of Agreement
State programs. Id. The correspondence
[[Page 68977]]
thus concludes that ``the IMPEP, together with designation of the
constraint rule as category 2 for compatibility purposes, provide
objective criteria to be used in assessing Agreement State regulation
of air emissions and would provide a satisfactory legal basis for any
NRC action required to address deficiencies in Agreement State programs
including, if necessary, suspension or revocation of the Agreement
State program.'' Id. at 2
III. Final Rule to Rescind 40 CFR Part 61, Subpart I for NRC and
Agreement State Licensees
A. EPA Determination Under CAA Section 112(d)(9)
Section 112(d)(9) authorizes EPA to decline to regulate
radionuclide emissions from NRC licensees under the CAA provided that
EPA determines, by rule, and after consultation with NRC, that the
regulatory scheme established by NRC protects the public health with an
ample margin of safety. The legislative history of section 112(d)(9)
provides clear guidance as to what is meant by ``an ample margin of
safety to protect the public health'' and what process the
Administrator should follow in making that determination in a
rulemaking proceeding under section 112(d)(9). The Conference Report
accompanying S.1630 points out that the ``ample margin of safety''
finding under section 112(d)(9) is the same ``ample margin of safety''
requirement that governed the development of standards promulgated
under section 112 of the CAA prior to its amendment in 1990. The
conferees also made clear that the process the Administrator is
expected to follow in making any such determination under section
112(d)(9) is the process ``required under the decision of the U.S.
Court of Appeals in NRDC v. EPA, 824 F.2d 1146 (D.C. Cir. 1987) (Vinyl
Chloride).'' H. Rep. No. 101-952, 101st Cong., 2d Sess. 339 (1990),
reprinted in 1 A Legislative History of the Clean Air Act Amendments of
1990, at 1789 (1993) (hereinafter ``Legislative History CAAA90'').
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.
EPA specifically found when it promulgated 40 CFR part 61, subpart I,
that 10 mrem/yr would provide the requisite ``ample margin of safety.''
EPA conducted a two-step ``ample margin of safety'' analysis when it
promulgated subpart I in 1989, and EPA hereby incorporates that
analysis by reference as part of its present finding.
As EPA interprets section 112(d)(9), the Agency may rescind the
subpart I NESHAP as it applies to NRC licensed facilities other than
commercial nuclear power reactors if the Agency (1) consults with NRC,
(2) engages in public notice and comment rulemaking, and (3) finds that
the separate NRC regulatory program provides an equivalent level of
public health protection (i.e., an ample margin of safety) as would be
provided by implementation of subpart I. While a rulemaking to rescind
a standard applicable to NRC licensees may commence prior to
incorporation of all necessary elements in the NRC regulatory program,
the elements of the NRC program must be deemed adequate by EPA to fully
satisfy the statutory standard at the time EPA takes final action.
Section 112(d)(9) does not require exact equivalence between the
EPA and NRC programs applicable to a particular category of licensees
before EPA may decline to regulate radionuclide air emissions from that
category. This construction of section 112(d)(9) was expressly affirmed
by the Court of Appeals in its unpublished Memorandum opinion denying
the petition for review of EPA's rescission of subpart I as applied to
nuclear power reactors. Unpublished Opinion, Sierra Club, et al., v.
Environmental Protection Agency, No.95-1562 (D.C. Cir. October 22,
1996) at 4. Section 112(d)(9) 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 the EPA standard. Thus, if the NRC
program as a whole will assure that air 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.
Based on its study of NRC and Agreement State licensees, EPA has
already determined that current air emissions from such licensees cause
doses which are in compliance with the 10 mrem/yr standard in subpart
I. However, as EPA construes section 112(d)(9), EPA must also evaluate
the ability of the NRC and Agreement State program to assure that
emissions remain below the level required to provide an ``ample margin
of safety.'' Thus, in deciding whether EPA may decline to regulate a
particular category or subcategory of NRC or Agreement State licensees
presently regulated under subpart I, 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 assumed by the State) in that category or subcategory will be
consistently and predictably at or below a level resulting in a dose of
10 mrem/yr, 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/yr to reduce the
emissions sufficiently that the dose will not exceed 10 mrem/yr.
EPA has previously concluded that radionuclide emissions to the
ambient air from NRC and Agreement State licensees other than nuclear
power reactors are generally well below the level that would result in
a dose exceeding 10 mrem/yr. EPA experience in administration of
subpart I since it became effective confirms this conclusion. Out of
the thousands of licensees subject to the standard, only 16 facilities
reported radionuclide air emissions exceeding the EPA standard for
calendar year 1993 and only one facility reported emissions exceeding
the EPA standard for calendar year 1994. No facilities reported
exceeding the subpart I 10 mrem/yr standard for calendar year 1995. See
Memorandum to Docket A-92-50 from Byron Bunger, December 18, 1996,
Docket Entry A-92-50, IV-B-2 (Appendix to final rulemaking describing
EPA's experience implementing Subpart I). Most of the reported
exceedances were resolved through EPA approval of appropriate site-
specific adjustments to the input parameters for COMPLY, the computer
code used for calculating doses. The one exceedance not resolved
through adjustments to the input parameters for COMPLY was
satisfactorily resolved by the facility.
EPA concludes that the final adoption by NRC of the NRC constraint
rule and the satisfactory resolution by NRC of prior deficiencies in
NRC Agreement State policies and procedures resolve all remaining
concerns regarding the adequacy of the NRC program to provide an
``ample margin of safety'' and support the requisite determination for
rescission under CAA section 112(d)(9). Promulgation of the NRC
constraint rule assures that radionuclide emissions by the affected
licensees will be consistently and predictably below a level which
would result in a dose exceeding 10 mrem/yr, and that NRC can require
an individual licensee who exceeds the 10 mrem/yr level to take
[[Page 68978]]
corrective actions to reduce emissions. By making the NRC constraint
rule a matter of Division Level 2 compatibility, NRC has assured EPA
that those licensees regulated by individual Agreement States also will
be subject to the 10 mrem/yr constraint level and will be required to
report and correct any exceedances of that level. Finally, the adoption
by NRC of policies establishing specific criteria for adequacy and
compatibility, and procedures for suspension or termination of
Agreement State programs resolves the Agency's concerns regarding the
ability of NRC to act if it determines that an Agreement State program
is inadequate or incompatible.
EPA is confident that NRC has the capability to enforce the
provisions of the constraint rule through its inspection and
enforcement programs. According to NRC, NRC's inspection program is
based on conducting on-site inspections of each licensee's facility at
frequencies determined partly by the size of the operation and the
amount of radioactive materials the licensee is authorized to possess.
Inspection frequencies appear to vary from a high of once per year for
large licensees to once every five years for very small licensees.
However, EPA understands that the majority of licensees authorized to
possess any significant amounts of radioactive materials are inspected
at frequencies ranging from one to three years. The Agency also notes
that inspection frequencies may be adjusted by NRC as needed, and
increased for licensees who have been subjected to certain NRC
enforcement actions.
NRC's enforcement program is addressed in the NRC's Enforcement
Policy, NUREG-1600, ``General Statement of Policy and Procedure for NRC
Enforcement Actions,'' (60 FR 34381, June 30, 1995). All violations
identified through inspections and investigations are subject to civil
enforcement action and may also be subject to criminal prosecution.
After an apparent violation is identified, the severity is evaluated in
order to determine the appropriate enforcement sanction. Severity
levels range from Level I for the most significant violations, to Level
IV for those of more than minor concern. Minor violations are not
subject to formal enforcement action. The NRC uses three primary
enforcement sanctions: Notices of Violation, civil penalties, and
orders. A Notice of Violation (NOV) sets forth one or more violations
of a legally binding requirement and normally requires a response from
the licensee describing the reasons for the violation, the corrective
steps taken or planned, and the date when actions will be complete. A
civil penalty is a monetary fine considered for Severity Level III
violations and are normally assessed for Severity Level I and II
violations and knowing and conscious violations of the reporting
requirements of Section 206 of the Energy Reorganization Act. In
addition to NOVs and civil penalties, orders may be used to modify,
suspend, or revoke licenses. Orders may require additional corrective
actions, such as removing specified individuals from licensed
activities or requiring additional controls or outside audits. Persons
adversely affected by orders that modify, suspend, or revoke a license,
or that take other action may request a hearing.
In addition to the inspection and enforcement programs, NRC
conducts periodic reviews of the Agreement State radiation control
programs. During those reviews, the NRC staff evaluates whether (1) the
Agreement State has a compatible regulatory program, (2) the Agreement
State is periodically conducting inspections of licensed activities
involving agreement material to provide reasonable assurance of safe
licensee operations and to determine compliance with its regulatory
requirements, and (3) the Agreement State is taking timely enforcement
action against licensees, when necessary, through legal sanctions
authorized by state statutes and regulations.
Based on the above analysis, EPA is today determining that the NRC
regulatory program for licensees other than commercial nuclear power
reactors provides an ample margin of safety to protect the public
health under CAA section 112(d)(9).
IV. Summary of Major Comments and Responses to Comments From 1992
NPRM and Notice Reopening Comment Period
This section briefly describes the major comments EPA received in
response to the Agency's rulemaking to rescind subpart I for NRC and
Agreement State licensed facilities other than commercial nuclear power
reactors. EPA received numerous written comments in response to the
December 1, 1992, proposal and the September 28, 1995, notice inviting
additional comments. The Agency also received comments during public
hearings conducted on January 14, 1993 and February 29, 1996.
Additionally, the Agency received comments on the specific issue of
whether to rescind subpart I for facilities other than commercial
nuclear power reactors during the comment period for other rulemakings,
e.g., the proposed stays discussed above. The Agency stated at the time
of those rulemakings that such comments would be addressed in the
context of this rulemaking on rescission. Comments received by the
Agency during the pendency of this rulemaking, together with relevant
comments received in other rulemakings, are addressed in the Response
to Comments Document which has been placed in the docket for this
rulemaking.
A major concern expressed by commenters relates to the lack of any
provision in the Atomic Energy Act (AEA) equivalent to the broad
authority to file citizen suits provided by Clean Air Act section 304.
Commenters asserted that the absence of a citizen suit provision
applicable to the NRC regulatory program would prevent a determination
by EPA that the EPA and NRC regulatory programs are equally stringent.
While EPA believes that this difference in the respective enabling
statutes of the two agencies could be properly considered by EPA as one
factor in deciding whether or not to exercise its discretion to
rescind, EPA does not believe that this difference precludes the
substantive finding required by section 112(d)(9). When Congress
adopted section 112(d)(9), Congress was aware that the CAA includes
citizen suit authority and that the AEA has no comparable provisions.
Despite this difference, Congress clearly envisioned that circumstances
might be such that EPA would make the finding required by section
112(d)(9) of the CAA. EPA notes that the same argument concerning the
absence of citizen suit authority was recently rejected by the District
of Columbia Court of Appeals in an unpublished opinion upholding the
Agency's rescission of subpart I for nuclear power reactors.
Unpublished Opinion, Sierra Club, et al., v. Environmental Protection
Agency, No.95-1562 (D.C. Cir. October 22, 1996).
In making today's ample margin of safety determination under
section 112(d)(9), the Agency considered whether future emissions from
licensees will be consistently and predictably at or below a level
resulting in a dose of 10 mrem/yr and whether, in the event a licensee
exceeds that level, NRC or an Agreement State can and will require the
licensee to reduce emissions. In the event that the NRC regulatory
program does not assure that licensee emissions result in doses at or
below 10 mrem/year, any interested person may petition EPA to initiate
a rulemaking to reinstate subpart I. Furthermore, EPA can act on its
own initiative to reconsider the rescission if new information
indicates
[[Page 68979]]
that the public health is not protected with an ample margin of safety.
Some commenters were also concerned about the regulatory authority
of the states and how actions 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
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. Docket Entry A-
92-50, IV-D-21. Mr. Bernero stated that the NRC Office of 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 [sic] 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. NRC has also stated
in the preamble to the final constraint rule that ``[T]he Commission
believes that [CAA section 112(d)(9] clarifies that EPA's determination
regarding NRC and Agreement State licensees has no effect on the
existing authority of States to impose air emission standards that are
more stringent than those of EPA.'' Furthermore, as noted earlier, the
Commission's designation of the constraint rule as a Division Level 2
matter of compatibility allows the Agreement States to set more
stringent standards than the NRC constraint rule. 61 FR 65120, 65126
(December 10, 1996). In addition, this issue was extensively discussed
by the Senate during floor debate for the 1990 CAA amendments. Passage
of the ``Simpson Amendment'' (section 112(d)(9)) failed on the first
vote due to concerns that the amendment somehow affected states' rights
and the question of state authority had to be addressed before the
amendment ultimately succeeded in passage. As explained by Senator
Burdick, ``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 CAA, 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 S3798.
Some commenters object to the EPA rescission based on the argument
that the NRC constraint rule is not an enforceable standard. As
discussed above, section 112(d)(9) does not require exact equivalence
between the EPA and NRC regulatory programs before EPA may decline to
regulate radionuclide emissions from a particular category or
subcategory of NRC licensees. Rather, section 112(d)(9) requires EPA to
determine that the NRC regulatory program as a whole will protect
public health to the same or greater level as would implementation of
subpart I. The study conducted by EPA as described above, the Agency's
experience in implementing subpart I since it became effective in 1992,
and NRC's recent adoption of the constraint rule and Agreement State
policies provide ample basis for EPA to conclude that public health
will be protected to the same level as would be achieved through
continued implementation of subpart I. Although the NRC constraint
level is not like the EPA standard in subpart I, in that exceeding the
constraint is not itself an actionable violation, the constraint level
is a value above which licensees must take actions to reduce emissions.
Thus, EPA may conclude that future doses to members of the public
caused by emissions of radionuclides from this category of facilities
will be predictably and consistently at or below 10 mrem/yr and that
NRC can and will take action in the event a facility exceeds the 10
mrem/yr level.
Commenters also expressed concern that the constraint rule does not
limit doses from radioiodine to the 3 mrem/yr level of subpart I. Doses
resulting from emissions of radioiodines were specifically considered
as part of the EPA study described in detail above. The study
demonstrated that no facility surveyed emitted a level of radioiodines
causing a dose above 1 mrem/yr, and extrapolation of the survey data
indicated that no licensed facility was expected to have emissions
exceeding the EPA standard. Based on all of the information now
available concerning the activities of NRC and Agreement State
licensees, EPA believes that it is very unlikely that any licensee who
is in compliance with the constraint level for all radionuclides of 10
mrem/yr will have radioiodine emissions exceeding the present EPA
standard. Accordingly, EPA does not consider the absence of a separate
limit for radioiodines in the NRC program to be a factor which will
prevent the NRC program from providing an ample margin of safety.
Some commenters expressed an additional concern regarding the
adequacy of the constraint rule based on the fact that Agreement States
have three years in which to adopt the constraint rule after it has
been finally adopted by NRC. The commenters are apparently concerned
that there will be up to a three year gap in regulatory coverage in
some individual Agreement States before a state version of the
constraint rule can be adopted. EPA understands this hypothetical
concern, but believes that it is misplaced for the following reason.
The general ALARA requirement is already legally enforceable in every
Agreement State. Whatever the opinion of any individual Agreement State
in the past as to what ALARA requires an individual licensee to do, the
constraint rule constitutes an authoritative conclusion by NRC that
ALARA consistently requires that each licensee at least achieve
emissions no greater than 10 mrem/yr. In light of the expert
determination by NRC that licensees can readily achieve levels less
than 10 mrem/yr, it would be difficult if not impossible for individual
Agreement States to properly construe existing ALARA requirements less
stringently. While EPA does not expect any individual Agreement State
to accept emissions exceeding 10 mrem/year as ALARA, even before
adoption of that State's own constraint level, were this to occur EPA
would initiate consultations with NRC concerning the adequacy of that
State's program and consider taking action to reimpose an EPA standard
if the problem were not promptly corrected. EPA also notes that
existing radionuclide standards adopted under State authority are not
affected by today's rescission.
The Agency also received several comments on the differences in
compliance calculation methodologies between NRC and EPA. The computer
code used to calculate compliance with Subpart I, COMPLY, considers
inhalation, immersion, ingestion, and exposure to contaminated ground.
Commenters question how the NRC constraint level, which only considers
inhalation and immersion, could provide an ample margin of safety to
protect the public health. As explained above, EPA does not believe
that section 112(d)(9) requires that every program element in the NRC
program be exactly equivalent to the corresponding element in the EPA
program. Such a construction would frustrate the evident Congressional
intent to relieve licensees of duplicative regulation. Rather, section
112(d)(9) requires only that EPA conclude that the regulatory programs
as a whole will provide the same level of protection of public health.
While there are differences in the calculation methodologies used by
EPA and NRC, EPA does not expect the differences in the manner in which
doses are
[[Page 68980]]
calculated to lead to significant differences in the resultant level of
protection of public health. While 16 facilities reported exceeding the
subpart I standard for calendar year 1993, that number decreased
significantly with no facilities reporting exceedances for calendar
year 1995. See Memorandum to Docket A-92-50 from Byron Bunger, December
18, 1996, Docket Entry A-92-50, IV-B-2 (Appendix for final rulemaking
describing EPA's experience implementing subpart I).
Another commenter was concerned that subpart I controls emissions
of NARM [Naturally Occurring and Accelerator Produced Radioactive
Materials] that are not subject to NRC licensing. EPA recognizes that
emissions of NARM by NRC licensees are not formally subject to NRC
licensure. However, although subpart I is nominally applicable to
emissions of both licensed materials and NARM, EPA did not adopt
subpart I in the first place based on any concern that emissions of
unlicensed radionuclide materials by NRC licensees would present any
hazard to public health. However, the definition of public dose in 10
CFR 20.1003 states: ``Public dose means the dose received by a member
of the public from exposure to radiation and/or radioactive material
released by a licensee, or to any other source of radiation under the
control of the licensee. Public dose does not include occupational dose
or doses received from background radiation, from any medical
administration the individual has received, or from voluntary
participation in medical research programs.'' The section on ``any
other source of radiation under the control of the licensee'' suggests
that NRC licensees are required to protect the public from most NARM
co-mingled with their licensed material, but not background
radiation.'' Moreover, in a letter to EPA, NRC stated that such
emissions already are controlled and will continue to be controlled to
levels which protect the public with an ample margin of safety. See
Docket Entry A-92-50, IV-D-21. NRC explained that ``At NRC-licensed
facilities, as a practical matter, licensees will control NARM
emissions as if they were byproduct material emissions.'' Id. at p. 2.
V. Judicial Review
Any petition for judicial review of the final rule must be filed in
the United States Court of Appeals for the District of Columbia on or
before February 28, 1997. Only an objection to this 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.
VI. Miscellaneous
A. Paperwork Reduction Act
There are no information collection requirements in this final
rule.
B. 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 is a significant regulatory action as that term is
defined in Executive Order 12866, since it raises novel legal or policy
issues. Thus, EPA has determined that rescinding subpart I as it
applies to facilities licensed by the NRC or NRC Agreement States which
are not engaged in the generation of commercial nuclear power is a
``significant regulatory action'' under the terms of Executive Order
12866 due to the presence of novel policy issues and is therefore
subject to OMB review.
C. Submission to Congress and the General Accounting Office
Under 5 U.S.C. 801(a)(1)(A) as added by the Small Business
Regulatory Enforcement Fairness Act of 1996 (SBREFA), EPA submitted a
report containing this rule and other required information to the U.S.
Senate, the U.S. House of Representatives and the Comptroller General
of the General Accounting Office prior to publication of the rule in
today's Federal Register. This rule is not ``major'' as defined by 5
U.S.C. 804(2) because it will not result in an annual effect on the
economy of $100 million or more; there is no major increase in costs or
prices to consumers, industries, governments or geographic regions; or
significant adverse effects on competition, employment, investment,
productivity, innovation and United States firms'' ability to compete
with foreign counterparts.
D. Regulatory Flexibility Analysis
EPA has determined that it is not necessary to prepare a regulatory
flexibility analysis in connection with this final rule. EPA has also
determined that this rule will not have a significant impact on a
substantial number of small entities. Today's final action is
deregulatory; effectively reducing the regulatory burden on NRC
licensees other than commercial nuclear power reactors by rescinding
the applicable regulatory requirements.
E. Unfunded Mandates Reform Act
Section 202 of the Unfunded Mandates Reform Act of 1995 (``Unfunded
Mandates Act'') requires that the Agency prepare a budgetary impact
statement before promulgating a rule that includes a Federal mandate
that may result in expenditure by State, local, and tribal governments,
in aggregate, or by the private sector, of $100 million or more in any
one year. Section 203 requires the Agency to establish a plan for
obtaining input from and informing, educating, and advising any small
governments that may be significantly or uniquely affected by the rule.
Under section 205 of the Unfunded Mandates Act, the Agency must
identify and consider a reasonable number of regulatory alternatives
before promulgating a rule for which a budgetary impact statement must
be prepared. The Agency must select from those alternatives the least
costly, most cost-effective, or least burdensome alternative that
achieves the objectives of the rule, unless the Agency explains why
this alternative is not selected or the selection of this alternative
is inconsistent with law.
The Agency has not prepared a budgetary impact statement or
specifically addressed the selection of the least costly, most cost-
effective, or least burdensome alternative because this final rule is
estimated to result in expenditures by State, local, and tribal
governments or the private sector of less than $100 million in any one
year. Because small governments will not be significantly or uniquely
affected by this rule, the Agency is not required to develop a plan
with regard to small governments. As discussed in the preamble, the
final rule has the effect of reducing overall regulatory burdens on
[[Page 68981]]
NRC licensed facilities other than commercial nuclear power reactors.
List of Subjects in 40 CFR Part 61
Environmental protection, Air pollution control, Benzene, Hazardous
substances, Radionuclides, Radon, Vinyl Chloride.
Dated: December 20, 1996.
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. Part 61 is amended by revising the heading for subpart I and by
revising Sec. 61.100 to read as follows:
Subpart I--National Emission Standards for Radionuclide Emissions
From Federal Facilities Other Than Nuclear Regulatory Commission
Licensees and Not Covered by Subpart H
Sec. 61.100 Applicability.
The provisions of this subpart apply to facilities owned or
operated by any Federal agency other than the Department of Energy and
not licensed by the Nuclear Regulatory Commission, 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.
Sec. 61.101 [Amended]
3. Section 61.101 is amended by removing paragraphs (a) and (e) and
redesignating paragraphs (b), (c), (d) and (f) as (a), (b), (c), and
(d) respectively.
Sec. 61.107 [Amended]
4. Section 61.107 is amended by removing and reserving paragraph
(c)(1).
[FR Doc. 96-32977 Filed 12-27-96; 8:45 am]
BILLING CODE 6560-50-P
