[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.

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

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