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

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