[Federal Register Volume 61, Number 238 (Tuesday, December 10, 1996)]
[Rules and Regulations]
[Pages 65120-65127]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-31221]


      

[[Page 65119]]

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Part III





Nuclear Regulatory Commission





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10 CFR Part 20



Clean Air Act: Radioactive Materials Airborne Effluents Dual Regulation 
Resolution; Final Rule and Radiation Protection Programs Enforcement 
Actions Policy and Procedure; Notice

  Federal Register / Vol. 61, No. 238 / Tuesday, December, 10, 1996 / 
Rules and Regulations  

[[Page 65120]]



NUCLEAR REGULATORY COMMISSION

10 CFR Part 20

RIN 3150-AF31


Resolution of Dual Regulation of Airborne Effluents of 
Radioactive Materials; Clean Air Act

AGENCY: Nuclear Regulatory Commission.

ACTION: Final rule.

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SUMMARY: The Nuclear Regulatory Commission is amending its regulations 
to establish a constraint of 10 mrem (0.1 mSv) per year total effective 
dose equivalent (TEDE) for dose to members of the public from air 
emissions of radionuclides from NRC licensed facilities other than 
power reactors. This action is necessary to: Provide assurance to the 
Environmental Protection Agency (EPA) that future emissions from NRC 
licensees will not exceed dose levels that EPA has determined will 
provide an ample margin of safety; and to provide EPA a basis upon 
which to rescind its Clean Air Act (CAA) regulations as defined in 40 
CFR Part 61 for NRC licensed facilities (other than power reactors) and 
Agreement State licensees, thereby relieving these licensees from 
unnecessary dual regulations.

EFFECTIVE DATE: This rule will become effective January 9, 1997.

FOR FURTHER INFORMATION CONTACT: Alan K. Roecklein, Office of Nuclear 
Regulatory Research, U.S. Nuclear Regulatory Commission, Washington, DC 
20555-0001, telephone (301) 415-6223.

SUPPLEMENTARY INFORMATION:

Background

    The EPA promulgated National Emission Standards for Hazardous Air 
Pollutants (NESHAPs) for radionuclides on October 31, 1989. Under 40 
CFR Part 61, Subpart I, emissions of radionuclides must be limited so 
that no member of the public would receive an effective dose equivalent 
greater than 10 mrem (0.1 mSv) per year.1 Subpart I of 40 CFR Part 
61 was promulgated to implement the CAA and limit doses to members of 
the public from air emissions of radionuclides (other than Radon-222) 
from all NRC licensees other than licensees possessing only sealed 
sources, high-level waste repositories, and uranium mill tailings piles 
that have been disposed of in accordance with 40 CFR Part 192. Radon-
222 emissions from tailings were covered by 40 CFR Part 61, Subparts T 
(addressing non-operational uranium mill tailings piles) and W 
(addressing operating mill tailings piles). EPA rescinded Subpart T for 
NRC licensees after Appendix A to 10 CFR Part 40 was amended by the 
Commission to conform to changes EPA issued to 40 CFR Part 192. Subpart 
W still applies to NRC licensees. Because Radon-222 is adequately 
addressed in 10 CFR Part 40, Appendix A, and other provisions of 10 CFR 
Part 20, it is not covered in this final rulemaking.
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    \1\ 1 Subpart I expresses dose in effective dose equivalent 
(EDE). NRC expresses dose in total effective dose equivalent (TEDE). 
These terms are essentially equivalent.
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    In 1990, Congress enacted amendments to the CAA. Section 112(d)(9) 
of these amendments to the CAA (the Simpson amendment) states:

    No 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 this section 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 public health.

    Upon issuance, the effectiveness of Subpart I for all NRC licensees 
was immediately stayed by EPA pending further evaluation. During the 
stay period, EPA conducted two studies of the air emissions from NRC 
and Agreement State materials licensees. The first was a survey of 367 
randomly selected nuclear materials licensees. EPA determined that the 
highest estimated dose to a member of the public from air emissions 
from these facilities was 8 mrem (0.08 mSv) per year, based on very 
conservative modeling. In addition, 98 percent of the facilities 
surveyed were found to have doses to members of the public resulting 
from air emissions less than 1 mrem (0.01 mSv) per year. The second 
study evaluated doses from air emissions at 45 additional facilities 
that were selected because of their potential for air emissions 
resulting in significant public exposures. EPA found that 75 percent of 
these licensees had air emissions resulting in an estimated maximum 
public dose less than 1 mrem (0.01 mSv) per year. For the licensees 
evaluated, none exceeded 10 mrem (0.1 mSv) per year.
    In its initial proposal to rescind Subpart I for NRC licensees 
other than power reactors, EPA stated that:

    Based on the results of the survey undertaken by EPA and the 
commitments made by NRC in the MOU, EPA has made an initial 
determination that the NRC program under the Atomic Energy Act 
provides an ample margin of safety to protect public health (57 FR 
56880; December 1, 1992).

    However, EPA continued to express concern regarding the adequacy of 
the measures to assure that future emissions from NRC licensees will 
not exceed levels that will provide an ample margin of safety. The stay 
on Subpart I expired on November 15, 1992, and Subpart I became 
effective on November 16, 1992. Subsequently, in July of 1993, the EPA 
Administrator determined that there was insufficient basis at that time 
to rescind Subpart I. Consequently, NRC and Agreement State licensed 
facilities were subject to dual regulation of airborne effluents of 
radionuclides under both the AEA and the CAA, including regulatory 
oversight by EPA (or authorized State) and NRC (or Agreement State).
    NRC licensees subject to EPA's Subpart I are also subject to NRC 
dose limits for members of the public contained in 10 CFR Part 20, 
Subpart D, entitled ``Radiation Dose Limits for Individual Members of 
the Public'' (Subpart D). Under Subpart D, licensees shall ensure that 
doses to members of the public are less than 100 mrem (1.0 mSv) per 
year from all pathways (including airborne effluents) and all sources 
associated with the licensee's operation. In addition, under Subpart B, 
entitled ``Radiation Protection Programs,'' licensees must ensure that 
doses to members of the public be kept as low as is reasonably 
achievable (ALARA). Based on the studies conducted by EPA and licensee 
reporting of doses to members of the public from airborne effluents to 
EPA, it is evident that less than 10 mrem( 0.1 mSv) per year to the 
maximally exposed member of the public from airborne radioactive 
effluents to the environment is reasonably achievable.
    NRC power reactor licensees subject to 10 CFR 50.34a must keep 
doses to members of the public from airborne effluents consistent with 
the numerical guidelines in Appendix I to 10 CFR Part 50. These 
licensees have reported estimated doses to members of the public from 
air emissions well below the Subpart I value for many years. Based on 
the combination of a continuing regulatory basis for reduced air 
emissions and documented proof of the effectiveness of the NRC program 
for these licensees, EPA rescinded Subpart I for power reactors 
licensed by NRC (60 FR 37196; September 5, 1995).

Amendments

    The amendments proposed on December 13, 1995 (60 FR 63984), and

[[Page 65121]]

finalized in this rule establish a constraint of 10 mrem (0.1 mSv) per 
year TEDE to members of the public from airborne radioactive effluents 
to the environment from NRC-licensed facilities, other than power 
reactors, as a part of its program to maintain doses ALARA. These 
amendments codify numerical values for NRC's application of ALARA 
guidelines for radioactive air emissions from its licensees, other than 
power reactors. For power reactors, ALARA guidelines have already been 
established within 10 CFR Part 50 and existing facility licensing 
conditions. These final amendments ensure that air emissions are 
maintained at very low levels and, taking into consideration the 
elimination of dual regulation, at some reduced cost to licensees. This 
action brings consistency between the EPA's dose standard and the NRC's 
ALARA application, and is expected to be the final step in providing 
EPA with the basis to rescind Subpart I as it applies to NRC-licensed 
facilities other than power reactors. NRC has been working 
cooperatively with EPA to achieve rescission of EPA's standards in 40 
CFR Part 61, Subpart I, under Section 112(d)(9) of the CAA. EPA 
published a proposed rescission of 40 CFR Part 61, Subpart I, on 
December 1, 1992 (57 FR 56877). On September 28, 1995, EPA published a 
notice in the Federal Register reopening the comment period on 
rescission of Subpart I (60 FR 50161). The objective of this effort is 
to eliminate duplicative regulations that provide no incremental 
benefit in terms of public and environmental protection.
    The regulatory framework that NRC is providing as a basis for 
rescission of EPA's Subpart I consists of the requirement in 10 CFR 
Part 20 to limit doses to members of the public to 100 mrem (1.0 mSv) 
per year, and the requirement to constrain doses to members of the 
public from airborne effluents of radioactive materials to the 
environment from a single licensed operation to 10 mrem (0.1 mSv) per 
year.
    Currently, under Sec. 20.1501 licensees are required to make or 
cause to be made surveys that may be necessary to comply with the 
regulations in 10 CFR Part 20. This data would be made available to 
inspectors upon request. If the licensee estimates or measures a dose 
to the nearest resident from air emissions greater than 10 mrem (0.1 
mSv) per year, the licensee would be required to report the dose to NRC 
in writing within 30 days, which would include the circumstances that 
led to the greater than 10 mrem (0.1 mSv) per year dose, a description 
of the corrective steps the licensee had taken or proposed to take to 
ensure that the constraint is not again exceeded, a timetable for 
implementing the corrective steps, and the expected results. Records of 
the results of measurements and calculations needed to evaluate the 
release of radioactive effluents to the environment will still be 
required pursuant to 10 CFR 20.2103(b)(4).
    Exceeding this constraint will not result in a Notice of Violation 
(NOV) as would be the case if a limit needed for adequate protection of 
public health and safety were exceeded. In the case of the constraint 
rule, an NOV will be issued only if and when (1) a licensee fails to 
report an actual or estimated dose from airborne effluent releases from 
a facility that has exceeded the constraint value; or (2) if a licensee 
fails to institute agreed upon corrective measures intended to prevent 
further airborne effluents in excess of those which would result in 
doses exceeding the constraint level.
    The rule applies to airborne effluents of radioactive materials to 
the environment, other than Radon-222 and daughters, from all NRC 
licensees except power reactors. Power reactors are exempt from this 
rule because they are already required, under 10 CFR 50.34a, to 
identify design objectives and the means to be employed for keeping 
doses to members of the public from air effluents ALARA in their 
license application. Appendix I to 10 CFR Part 50 contains the 
numerical guidelines to meet this requirement.

Response to Comments

    Fifty-seven individuals and organizations provided written comments 
on the proposed rule and Draft Regulatory Guide DG-8016. Among the 57 
commenters, 24 were licensees, seven were professional organizations, 
five were States, 16 were members of the public, and five were 
environmental organizations. Because many letters commenting on the 
Draft Regulatory Guide DG-8016 also included comments on the rule, 
these comments were also considered in developing the final rule.

Issue 1--Proposed Rule Approach

    Comments: A total of thirty-one individuals and organizations 
commented on the basis for the rule. Five commenters agreed with the 
approach and need for the constraint. Four commented that the rule 
should not be finalized and that EPA's Subpart I should remain in 
effect. Twenty-two commenters stated that existing NRC programs 
provided an ample margin of safety and that the constraint was not 
needed. However, of these, seven agreed that the constraint was 
preferable to dual regulation or Subpart I alone.
    Those commenting that existing NRC programs are adequate to protect 
the public cited the two EPA studies on doses from air emissions. Two-
thirds of these commenters were opposed to going forward with the 
constraint because they believed it was not needed and that licensee 
and regulator costs could not be justified given the expectation that 
risk to public health and safety would not be reduced. These commenters 
encouraged NRC to continue working with EPA to provide sufficient basis 
for rescission of Subpart I without the imposition of an equally 
unnecessary regulation. A few commenters stated that the risk was 
considerably less than estimated because excessively conservative 
calculational methods were used by EPA. A few commenters compared the 
10 mrem (0.1 mSv) per year constraint to variability in background or 
doses from commercial air traffic as evidence that the dose and the 
risk is trivial. Seven commenters cited burden reduction and single-
agency oversight as the reasons for agreeing that the constraint was 
preferable to dual regulation or EPA's Subpart I alone.
    Commenters opposed to the constraint as a less protective standard, 
stated that the constraint was based upon a voluntary program (ALARA) 
and, as such, was not adequate to protect the public. One commenter 
stated that NRC does not perform confirmatory measurements and 
therefore, NRC jurisdiction was not adequate.
    Response: NRC and EPA have been working to develop a basis upon 
which dual regulation could be eliminated. EPA has stated that there 
are two necessary components to any finding that NRC's program is 
sufficient to protect the health and safety of the public. The first is 
evidence that doses from air emissions are below 10 mrem (0.1 mSv) per 
year to a member of the public. This has been demonstrated through the 
two studies by EPA and by licensee reporting of actual air emissions. 
The second component is a program to ensure that doses remain at this 
level. In the absence of rulemaking requiring licensees to maintain 
doses to levels of no more than 10 mrem (0.1 mSv) per year, EPA would 
not rescind Subpart I and dual regulation would continue.
    The Federal Radiation Council (FRC) was formed in 1959, to provide 
recommendations to the President for Federal policy regarding radiation 
matters that affect health. In May 1960, FRC set forth basic principles 
for

[[Page 65122]]

protection of both workers and the public. The council was abolished in 
1970 when its functions were transferred to the EPA Administrator. In 
1981, EPA published proposed recommendations for new Federal guidance 
for occupational exposure. In 1987, President Reagan approved 
recommendations by the EPA Administrator for new ``Radiation Protection 
Guidance to Federal agencies for Occupational Exposure.'' EPA has not 
yet issued recommendations on limits for the public. A working group 
comprised of representatives from affected Federal agencies and experts 
on radiological health matters has been developing these 
recommendations for several years and expects to provide them during 
the next year.
    In 1977, the International Council on Radiological Protection 
(ICRP) issued its Report No. 26 ``Recommendations of the International 
Council on Radiological Protection'' in 1977. These recommendations 
concluded that the average doses to members of the public should not 
exceed 100 mrem (1.0 mSv) per year with a limit of 500 mrem (5.0 mSv) 
per year to any individual.
    The National Council on Radiation Protection and Measurements 
(NCRP) is required by Congress to recommend limits for exposure to 
ionizing radiation. In June 1987, NCRP issued its Report No. 91, 
``Recommendations on Limits for Exposure to Ionizing Radiation.'' This 
report contains recommendations on exposure limits for both 
occupationally exposed individuals and individual members of the 
public. The report recommended that doses to individual members of the 
public be limited to 100 mrem (1.0 mSv) per year averaged over a 
lifetime, not to exceed 500 mrem (5.0 mSv) in 1 year.
    In 1991, NRC revised 10 CFR Part 20 ``Standards for Protection 
Against Radiation.'' This revision included new limits for individual 
members of the public. Though both the ICRP and the NCRP recommended 
limits of 500 mrem (5.0 mSv) in any one year, the NRC established a 
limit of 100 mrem (1.0 mSv) per year because it was impractical to 
control dose in terms of lifetime average without keeping track of 
individual exposures. In addition, 10 CFR Part 20 requires that 
licensees use procedures and engineering controls to maintain doses 
ALARA.
    Both the NRC and EPA regulatory programs are designed to achieve 
protection of the public with an ample margin of safety. The approaches 
of the two agencies differ. NRC limits TEDE, requires that doses are 
maintained ALARA, and maintains an active inspection program. EPA 
limits dose from individual pathways of exposure and individual 
radionuclides to ensure that the total dose does not exceed recommended 
levels. Both programs achieve similar levels of protection.
    NRC agrees that adoption of the constraint in Sec. 20.1101(d) is 
preferable to dual regulation due to the reduction in burden on 
licensees as well as State and Federal agencies. Under the provisions 
of 40 CFR Part 61, licensees with doses to members of the public 
greater than 1 mrem (0.1 mSv) per year but less than 10 mrem (0.1 mSv) 
per year must submit reports. However, under 10 CFR 20.1101(d), these 
licensees will not have to file reports for doses below the constraint 
level because doses can be evaluated during routine inspections. Under 
the final rule, the burden of calculating doses should be reduced for 
most licensees because the proposed guidance for demonstrating 
compliance with 10 CFR 20.1101(d) allows significantly more flexibility 
and simpler methods for calculating doses than the model currently used 
to demonstrate compliance with 40 CFR Part 61. These new methods for 
calculating doses should result in fewer reporting and corrective 
actions, as under EPA's Subpart I.
    Licensees are required under Sec. 20.2103 to maintain records of 
surveys required to demonstrate compliance with the public dose limit. 
Review of licensee records used to demonstrate compliance with the 
public dose limit is part of the NRC inspection program. Confirmatory 
measurements would generally not be useful since most licensees in this 
category do not have routine ongoing effluent releases.
    Finally, concerning those commenters that believe NRC's 
requirements are less safe than Subpart I, Congress enacted legislation 
comprehensively amending the Clean Air Act (CAA), which included a 
section addressing the issue of regulatory duplication between EPA and 
NRC in 1990. The 1990 CAA amendments permit the EPA Administrator to 
rescind the CAA standards as they apply to radionuclides, at sites 
licensed by NRC, and the Agreement States, if he or she finds that the 
NRC regulatory program provides an ample margin of safety to protect 
public health.
    EPA's analysis of the NRC regulatory program focused on two general 
issues: (1) whether the implementation of the NRC regulatory program 
results in sufficiently low doses to protect the health and safety of 
the public with an ample margin of safety; and (2) whether the NRC 
program is sufficiently comprehensive and thorough, and administered in 
a manner that will continue to protect public health in the future. EPA 
undertook studies to determine the level of protection provided by the 
existing regulatory program and found that doses were sufficiently low 
to protect the health and safety of the public with an ample margin of 
safety. The implementation of this rule will ensure that doses to 
members of the public from air effluents will continue to remain below 
10 mrem (0.1 mSv) per year and provide evidence to EPA that the current 
level of protection will continue.
    The purpose of this rulemaking is not to reduce doses, because it 
has already been demonstrated that doses are sufficiently low. The 
purpose is to ensure that doses are maintained at the low level 
currently achieved by NRC licensees, eliminate unnecessary dual 
regulation, and reduce costs associated with the current level of 
protection, by providing a basis upon which EPA can find that doses 
will not increase as a result of rescission of Subpart I.

Issue 2--Promulgation of the Constraint as ALARA

    Comments: There were a number of commenters who objected to the 
ALARA basis for the proposed constraint rule. Some commenters objected 
on the ground that ALARA is a matter of operating philosophy, good 
radiation protection practice and licensee judgment, and cannot be 
translated into an enforceable dose number. Other commenters objected 
on the basis that ALARA is inherently site specific and cannot be 
defined generically or that the proposed dose constraint cannot be 
ALARA but must be a limit because the constraint contemplates some 
enforcement actions for exceedance even if the licensee has followed 
all good radiation protection practices. Some commenters argued that 
the rule cannot be ALARA because it adds costs with no safety benefit. 
Other commenters stated that the constraint is inconsistent with a 
prior NRC decision in 10 CFR Part 20 (56 FR 23360) on the use of 
``reference levels.''
    Response: The Commission has retained an ALARA basis for the rule 
but recognizes that its use of the term in this rule may have led to 
some confusion. The Commission acknowledges that the ALARA concept in 
10 CFR 20.1003 is an operating philosophy which requires good radiation 
protection practice and the exercise of expert licensee judgement. The 
ALARA concept is site specific in that some of the factors to be 
considered may vary from case to case, as the court so found in York 
Committee for a Safe Environment v. NRC, 527 F. 2d 812

[[Page 65123]]

(D.C. Cir. 1975). The Commission has presumed, without deciding, that 
the ALARA concept in Sec. 20.1003 can be enforced in a particular case 
so as to require a specific radiation protection practice, but it is 
clear that the existing regulation does not translate readily into a 
generic dose number, which, if exceeded, will lead to enforcement 
action.
    The NRC intended the constraint rule to be a somewhat broader 
concept found in the governing statute, the Atomic Energy Act of 1954, 
as amended (Act). The Act, as construed by both the Commission (e.g., 
10 CFR 50.109) and the courts (Union of Concerned Scientists v. NRC, 
824 F.2d 108 (D.C. Cir. 1987)), contemplates two distinct approaches to 
radiological regulation. First, a level of ``adequate protection'' must 
be defined and enforced without regard to economic cost. Second, risk 
may be reduced to a level below that associated with ``adequate 
protection'' to ``minimize danger to life or property'' with economic 
cost and other factors as permissible balancing considerations. See 
``Revision of Backfitting Process for Power Reactors,'' (53 FR 20603; 
June 6, 1988). It is important to note that Section 161b of the Act 
authorizes the Commission to adopt and enforce generic requirements 
using either approach. Many recent NRC regulations (e.g., 10 CFR 50.63) 
have been directed at incremental risk reduction under the second 
approach based on a generic regulatory or backfit analysis which 
considered and balanced economic and other costs and safety backfits. 
These ``minimize danger'' regulations provide ``limits'' because they 
establish generic requirements directly enforceable against licensees. 
However, in a broad sense they are also ALARA regulations because cost, 
feasibility, and other relevant factors identified in 10 CFR 20.1003 
are evaluated.
    Viewed in its larger statutory context, the use of ALARA in 10 CFR 
20.1003 is one means to implement the second approach to radiological 
regulation. However, other similar requirements can also be part of 
this second approach. While the ALARA concept in 10 CFR 20.1003 may not 
be consistent with a generic enforceable dose requirement, other 
concepts of ALARA premised on generic considerations are appropriate. 
This concept of ALARA as a broadly applicable dose requirement based on 
a generic weighing and balancing of health and safety, feasibility, and 
other factors is the basis for the longstanding limits on nuclear power 
reactor emissions in 10 CFR Part 50, Appendix I, and is the basis for 
the constraint rule. The ALARA rule imposes a limit in the sense that 
exceedance will lead to corrective action, but it is not a limit in the 
sense that exceedance per se would constitute a violation of any 
regulatory requirement. A violation occurs only when a licensee fails 
to report an exceedance or fails to take appropriate corrective 
actions. A limit would be appropriate if compliance were needed to 
ensure adequate protection of public health and safety. In this case, 
the constraint is needed only to ensure that currently afforded levels 
of protection are not reduced. This will provide the basis for 
rescission of 40 CFR Part 61, Subpart I by EPA.
    Thus, to say that the constraint rule cannot be based on ALARA 
because it is in effect a ``limit,'' interchanges a narrow concept of 
``ALARA'' with a broad concept of ``limit.'' If a broad definition is 
used, the constraint rule withstands scrutiny as both ALARA and a 
limit. In the statutory context of the Atomic Energy Act and general 
principles of administrative law, the constraint rule is a limit based 
on generic ALARA considerations. The constraint rule is not a limit 
needed for adequate protection and the constraint rule is something 
more than a narrow translation of the particular ALARA concept 
contained in 10 CFR 20.1003. The term ``constraint'' was used for the 
rule to avoid confusion with the narrow concepts of ALARA and the limit 
employed in radiation protection discussion.
    Three matters must be addressed:
    (1) The comment that the rule cannot be based on ALARA because it 
will result in increased cost with no safety benefit;
    (2) The problem of the licensee who cannot meet the dose constraint 
despite using all good radiation protection practices; and
    (3) The allegedly inconsistent Commission discussion of reference 
levels in a recent revision to 10 CFR Part 20.
    The Commission disagrees with the premise of the first comment. 
There was no disagreement with the Commission's conclusion that all of 
the licensees affected by the rule are achieving a level of control 
such that doses are below the 10 mrem (0.1 mSv) per year level and so 
there is no factual dispute over whether this level of radiation 
protection is readily achievable. The final rule and EPA's rescission 
of its Clean Air Act emission limits and related requirements will 
result in a significant net cost savings to licensees. The NRC 
acknowledges that the positive direct health effects are likely to be 
small and possibly nonexistent in the near future, given the current 
level of controls. However, the rule can be said to offer a small, but 
positive, net health and safety benefit in that it will prevent a 
decrease in the level of protection afforded the public if Subpart I 
were rescinded in the absence of a rule like the constraint. Under the 
ALARA concept, it is appropriate to base a requirement on a small 
positive health and safety benefit when cost savings are also likely.
    The NRC does not expect that any licensee subject to the rule will 
be unable to demonstrate that doses to members of the public from 
releases of airborne radioactive materials to the environment are less 
than 10 mrem (0.1 mSv) per year. In the unlikely case that this dose is 
exceeded or is projected to be exceeded, due to some temporary 
circumstances or lapse in controls, the NRC expects the licensee to 
take whatever corrective actions are necessary (if any) to protect 
public health and safety, to report the dose, to recommend further 
corrective actions if necessary, and take those corrective actions 
agreed upon with NRC. NRC staff will review and approve corrective 
actions to ensure that they are appropriate to reduce airborne 
emissions sufficiently to comply with the constraint in the future. In 
the unlikely case that a licensee is unable to take adequate corrective 
actions, because of limits in technology or cost constraints, these 
issues can be addressed in the future on a case-by-case basis.
    The application of the ALARA principle used in this rule is not the 
same as the concept of reference level which was rejected by the 
Commission when 10 CFR Part 20 was recently revised. Commenters on the 
1991 revision to 10 CFR Part 20 objected to the use of reference levels 
because they were implemented exactly the same as adequate protection 
limits. For that reason, the Commission did not adopt reference levels 
in the 1991 revision. Implementation of the constraint is different 
than such a limit because exceeding the constraint is not a violation, 
and only requires the licensee to report the dose and take corrective 
actions to reduce future doses.

Issue 3--Whether the Constraint Is Actually a Limit

    Comments: Nine comments were received on whether the constraint is 
or should be a limit. Two commenters believed that the constraint was 
no different than a limit. One commenter agreed with the term 
constraint. Three commenters expressed concern that the constraint was 
an inappropriate relaxation of requirements.

[[Page 65124]]

    Those commenting that the constraint was a de facto limit 
interpreted the requirements to indicate that a second exceedance of 
the constraint would result in enforcement action and therefore the 
constraint is a limit. Three commenters indicated that the rule should 
be a strict limit. They expressed concern that the constraint was less 
protective than EPA requirements.
    Response: If a licensee exceeds a limit that is needed to protect 
health and safety, the NRC may take immediate enforcement action. If a 
licensee exceeds a constraint, the licensee will be required to notify 
NRC, take any actions that may be necessary to protect public health 
and safety, and implement any further corrective actions that NRC staff 
agrees are adequate to prevent further doses in excess of the 
constraint. However, if the licensee failed to report a measured or 
calculated dose in excess of the constraint to NRC or failed to 
implement appropriate corrective actions as agreed upon, enforcement 
action would be expected. This is because, unlike an adequate 
protection limit, the constraint is not needed to provide adequate 
protection of public health and safety.
    The NRC does not agree that the constraint is less protective than 
current EPA requirements. Both EPA's Subpart I and the NRC constraint 
require licensees to take actions to ensure that doses to members of 
the public do not exceed 10 mrem (0.1 mSv) per year from ambient air 
emissions. NRC routinely inspects licensed facilities to ensure that 
air effluents do not result in doses to members of the public that 
exceed the requirements in 10 CFR Part 20. The inspection and 
enforcement program will be amended as a result of this final rule to 
review licensee records used to demonstrate compliance with the 
constraint.

Issue 4--Citizen Suits

    Comments: Three commenters opposed finalization of the constraint 
on the basis that it forfeits citizen rights to sue a licensee who 
exceeds the constraint.
    Response: The Commission's regulations in 10 CFR 2.206 provide the 
public with the right to petition the NRC to take enforcement action 
against a licensee for a violation of the Commission's regulations. 
This would include the final constraint rule.

Issue 5--Agreement State Compatibility

    Comments: Four commenters addressed the proposal that the 
constraint be a Division 2 matter of compatibility. Under Division 2, 
States could adopt similar or more stringent requirements. Three 
commenters agreed that this rule should not be codified as a Division 2 
requirement, but rather as a Division 1 matter of compatibility. Under 
Division 1, the States would be required to adopt regulations that were 
essentially identical. These commenters believed that if stricter 
standards were permitted, reactor and non-reactor licensees would be 
under different requirements and certain practices, such as nuclear 
medicine, could be jeopardized. One commenter noted that because this 
is really a limit, it should be under 10 CFR 20.1301 and would be a 
Division 1 matter of compatibility. Another commenter stated that NRC 
should have provided a greater opportunity for State involvement in 
this rulemaking, and that as a division 2 rule, Agreement States would 
have to spend scarce resources to develop a compatible rule.
    Response: Section 116 of the Clean Air Act specifies that nothing 
precludes States from imposing air emission requirements that are more 
stringent than those developed by EPA. Section 116(d)(9), which 
contains the provisions related to EPA's margin of safety determination 
for NRC or Agreement State licenses, specifies that: ``Nothing in this 
subsection shall preclude or deny the right of any State or political 
subdivision thereof to adopt or enforce any standard or limitation 
respecting emissions of radionuclides which is more stringent than the 
standard or limitation in effect under Section 7411 of this title or 
this section.'' The Commission believes that this provision 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.
    With regard to the comment concerning involvement of the Agreement 
States in the development of this rule, NRC has routinely reported its 
progress on providing an adequate basis upon which EPA could rescind 
Subpart I to both the Organization of Agreement States (OAS) and the 
Conference of Radiation Control Program Directors (CRCPD) at each of 
their annual meetings. The Agreement States were consulted extensively 
on this issue over the last several years. There were extensive 
discussions of the concept with the individual States and with the 
Executive Board of the OAS.

Issue 6--Demographic Information Contained in Required Reports

    Comments: Seven commenters addressed the application of the 
requirement contained in 10 CFR 20.2203(b)(2) to the constraint. This 
section requires reports to contain demographic information on the 
exposed individual. These commenters expressed concern that a member of 
the public would be under no obligation to provide demographic 
information to licensees and that licensees would not always be able to 
comply with the requirement.
    Response: NRC agrees that members of the public may choose to 
withhold the demographic information from licensees. Such information 
is only needed for occupationally exposed individuals to ensure that 
lifetime exposure records are accurate. Section 20.2203 has been 
changed to only require such information on occupationally exposed 
individuals.

Issue 7--Effective Date

    Comment: One commenter requested that an effective date be added to 
the final rule to coincide with EPA's rescission of Subpart I. 
Response: The NRC and EPA will, to the extent possible, publish both 
final rules so that they become effective concurrently.

Issue 8--Enforcement

    Comments: Five commenters stated that NRC should establish a limit 
rather than a constraint. They believed that if the limit has been 
exceeded, a notice of violation and civil penalties should always 
result. One commenter expressed concern that ``self-reporting and 
confession'' is not adequate. Another stated that because ALARA is only 
guidance, it is not enforceable.
    Response: ALARA is not guidance. As stated previously, the 1991 
revision to 10 CFR Part 20 codified ALARA as a required part of the 
licensee's radiation protection program. A limit often implies that 
doses must be controlled below that level in order to provide adequate 
protection of health and safety of the public and workers. To meet 
ALARA requirements licensees are currently controlling effluents to 
levels below that which would be required under the constraint. If a 
licensee exceeds the constraint, the rule requires that this be 
reported and that corrective actions be promptly taken. If a licensee 
does not comply with the obligation to report and take corrective 
actions, enforcement action will result. In NRC's judgment, as a matter 
of enforcement policy, it is not necessary to issue a notice of 
violation or civil penalties upon exceedence of the constraint level; 
it is sufficient that this be reported and that prompt corrective 
action is taken.

[[Page 65125]]

Issue 9--Exemptions

    Comments: Five commenters stated that the rule should only apply to 
members of the public offsite. They cited the EPA's Subpart I 
requirement to calculate dose to the nearest resident or offsite 
individual likely to receive the highest dose. Under Subpart I, 
licensees would not calculate doses from air emissions to visitors in 
hospitals, workers that are not radiation workers within the facility, 
or other members of the public within the facility.
    Response: The language in the rule has been changed to reflect that 
it is intended to apply to radioactive airborne effluents to the 
environment. The Draft Regulatory Guide DG-8016 will be revised to 
indicate that the dose limit is to be calculated or measured at the 
nearest resident or individual offsite likely to receive the highest 
dose. The final regulatory guide will be available when the rule 
becomes effective.
    Comments: Two commenters stated that air emissions from adjacent 
nearby exempt uranium mills should not be included in the calculation 
of dose. One commenter stated that materials from unlicensed portions 
of the facility such as ore stockpiles should not be considered in the 
calculation of dose.
    Response: Subpart I 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. The 
constraint applies to airborne effluents of only licensed materials to 
the environment. Draft Regulatory Guide DG-8016 will be changed to 
clarify that windblown particulates from other licensed facilities or 
unlicensed materials do not need to be considered in the calculation of 
doses used to demonstrate compliance with the constraint.
    Comments: Four commenters stated that air emissions from patients 
should be exempted from this rule.
    Response: The regulatory impact analysis (NUREG-1492) for a recent 
NRC rulemaking analyzed potential doses from exposure to patients who 
were released after administration of radiopharmaceuticals. This 
analysis concluded that internal doses from inhalation of radioactive 
materials in the exhaled air of a released patient are trivial. For 
licensees using an inventory approach to demonstrating compliance with 
the rule, such as the COMPLY computer code, there is no need to account 
specifically for the materials that might be released to the air 
through respiration or transpiration by patients. The Regulatory Guide 
will make it clear that dose from air emissions from patients do not 
need to be specifically addressed in the calculation of dose used to 
demonstrate compliance with the constraint.
    Comments: Four commenters stated that in addition to Rn-222, all 
daughters produced after release should also be excluded.
    Response: EPA's Subpart I exempts both Rn-222 and any daughters 
produced after release of Rn-222 because these types of releases are 
normally not attributable to licensed activities. The proposed rule was 
not intended to be more stringent than Subpart I. The rule language has 
been changed to reflect this exemption.
    Comments: Two commenters recommended that in addition to Rn-222, 
Rn-220 and its daughters should also be exempted. One commenter stated 
that it was an EPA oversight that led to this erroneous omission from 
the final Subpart I.
    Response: Rn-220 is normally attributable to licensed activities. 
EPA does not exempt Rn-220 or its daughters from consideration in the 
dose calculations in support of demonstrating compliance with Subpart 
I. The commenter's suggestion that an oversight led to the erroneous 
omission of this exemption from Subpart I is incorrect, and Rn-220 
should not be excluded from the calculations that are used to 
demonstrate compliance with the constraint.
    Comments: Six commenters requested that in addition to sealed 
sources, sealed containers should also be excluded from the rule.
    Response: Paragraph 2(a) of Appendix D to 40 CFR Part 61 states: 
Radioactive materials in sealed packages that remain unopened, and have 
not leaked during the assessment period should not be included in the 
calculations.'' Subpart I exempts sealed packages, because any package 
that has remained sealed cannot contribute to airborne effluents. When 
a total inventory of licensed materials possessed during the year is 
used to model potential doses, it is unnecessary to include materials 
that could not have contributed to airborne effluents. The Regulatory 
Guide will provide further guidance on this issue.

Issue 10--Measurability of 10 mrem (0.1 mSv) Per Year

    Comments: Three commenters stated that 10 mrem (0.1 mSv) per year 
was not measurable. One commenter stated that although 10 mrem (0.1 
mSv) per year might be easily achievable, it is not easily measurable. 
Another stated that the exposure rate corresponds to 1 microR (0.01 
micro-Sv) per hour and cannot be measured accurately.
    Response: Draft Regulatory Guide DG-8016 provides several methods 
for demonstrating compliance with the constraint, and only one of the 
methods described would require direct measurement at the receptor 
location. If this method is not practical due to the emission 
characteristics of the radionuclide releases, there are other options 
cited in Draft Regulatory Guide DG-8016 that do not require a direct 
measurement to demonstrate compliance with the constraint.

Issue 11--Scope of the Rule

    Comments: One commenter stated that if there must be a constraint, 
it should apply to all licensees, including power reactor licensees.
    Response: Although this rule only applies to licensees other than 
power reactor licensees, the Commission's existing regulations in 10 
CFR Part 50, Appendix I, already establish a similar regulatory 
framework for power reactors. Appendix I includes separate requirements 
to develop design objectives and operational levels sufficient to 
demonstrate compliance with EPA's Subpart I. In addition, reactor 
licensees must annually report quantities of radioactive materials 
released into the environment, as well as the resulting doses.

Issue 12--Location of Constraint in NRC Regulations

    The Commission requested specific comment on the question of 
whether the 10 mrem (0.1 mSv) per year constraint should be established 
in 10 CFR Part 20 as proposed or whether it should be established 
separately in each appropriate part of Title 10 instead.
    Comments: Two comments were received in response to this issue. One 
commenter stated that the constraint should be in 10 CFR Part 20. The 
other commenter stated that the constraint should be in each 
appropriate part. Two other commenters stated that it should be in 
Sec. 20.1301 with the dose limits.
    Response: While the constraint could just as easily be included 
under other parts of the regulations, including it in 10 CFR Part 20 
provides uniformity. Because 10 CFR Part 20 is the designated area for 
radiation protection standards and related requirements, it is the 
appropriate location for the constraint. The rule will be codified 
under Sec. 20.1101 to make it clear that although the constraint is not 
the same as a limit, licensees are expected to develop radiation 
programs to ensure that doses from air emissions are below 10 mrem (0.1 
mSv) per year.

[[Page 65126]]

Agreement State Compatibility

    The Commission believes that the Division 2 compatibility 
designation for the rule is consistent with state authority in this 
area as described in the Clean Air Act. The Division 2 designation 
means that Agreement States must address these rules in their 
regulations but may adopt requirements more restrictive than those of 
NRC. Accordingly, the authority of the Agreement States to impose air 
emissions standards under their Atomic Energy Act authority after the 
effective date of this rule will be consistent with their existing 
authority. Under Section 274 of the Atomic Energy Act the Commission 
reviews Agreement State programs to ensure that adequacy and 
compatibility of the State Program is maintained. The Commission has 
also approved procedures to suspend or terminate programs that are not 
adequate or compatible.

Summary of Changes in the Final Rule

    Based on the responses to comments, a few changes were made in the 
final rule. Otherwise, the provisions of the final rule are the same as 
those presented in the proposed amendments. Specific changes to the 
final rule are summarized as follows:
    (1) Section 20.2203(b)(2) has been changed to require the name, 
social security number, and date of birth only for occupationally 
overexposed individuals and not for members of the public who have 
received doses in excess of the public limits, including the 
constraint.
    (2) The language of the rule has been changed to indicate that Rn-
222 and all daughters produced after the release of the radon are 
categorically excluded from this rule.
    (3) The language of the rule has been changed to indicate that the 
constraint applies only to release of airborne radioactive effluents to 
the environment and, thus, dose to the nearest resident, offsite 
business or school, is to be constrained.
    In addition, the following changes will be made to Draft Regulatory 
Guide DG-8016:
    (1) An inventory of radioactive materials used to model a potential 
dose to a member of the public need not include radioactive materials 
in sealed containers that have remained sealed throughout the 
compliance period.
    (2) Airborne emissions of radioactive materials from patients does 
not need to be considered if the materials have already been included 
in the site inventory.
    The Regulatory Guide was issued in draft for public comment 
concurrent with the proposed rule. The final regulatory guide will be 
available by the effective date of this rule.

Conforming Amendments To NRC's Enforcement Policy

    By separate notice in the Federal Register, the Commission is 
modifying its ``General Statement of Policy and Procedures for NRC 
Enforcement Actions'' (Enforcement Policy), to address the new 
regulation, and to provide an example Severity Level IV violation of 
the constraint. This change will also be reflected when the Enforcement 
Policy is reprinted in its entirety in the next revision of NUREG-1600.

Small Business Regulatory Enforcement Fairness Act

    In accordance with the Small Business Regulatory Enforcement 
Fairness Act of 1996, the NRC has determined that this action is not a 
``major rule'' and has verified this determination with the Office of 
Information and Regulatory Affairs, Office of Management and Budget.

Finding of No Significant Environmental Impact

    The Commission has determined under the National Environmental 
Policy Act of 1969, as amended, and the NRC's regulations in Subpart A 
of 10 CFR Part 51, that this rule, if adopted, would not be a major 
Federal action significantly affecting the quality of the human 
environment and therefore, an environmental impact statement is not 
required. This action is not expected to have any significant 
environmental impact because the programs will provide equivalent 
protection. Also, airborne effluents of radioactive materials to the 
environment are not expected to increase. The changes to the final rule 
are to the procedural methods for demonstrating compliance as well as 
licensing and inspection procedures. The environmental assessment and 
finding of no significant impact on which this determination is based 
are available for inspection and photocopying for a fee at the NRC 
Public Document Room, 2120 L Street NW. (Lower Level), Washington, DC.

Paperwork Reduction Act Statement

    This final rule amends information collection requirements that are 
subject to the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et. 
seq.). These requirements were approved by the Office of Management and 
Budget, approval number 3150-0014.
    The public reporting burden for this collection of information is 
estimated to average 80 hours per response, including the time for 
reviewing instructions, searching existing data sources, gathering and 
maintaining the data needed, and completing and reviewing the 
collection of information. Send comments on any aspect of this 
collection of information, including suggestions for further reducing 
this burden, to the Information and Records Management Branch (T-6 
F33), U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001, or 
by Internet electronic mail to [email protected]; and to the Desk Officer, 
Office of Information and Regulatory Affairs, NEOB-10202, (3150-0014), 
Office of Management and Budget, Washington, DC 20503.

Public Protection Notification

    The NRC may not conduct or sponsor, and a person is not required to 
respond to, a collection of information unless it displays a currently 
valid OMB control number.

Regulatory Analysis

    The NRC has prepared a regulatory analysis for this final rule. The 
analysis examines the costs and benefits of the alternatives considered 
by the NRC. In the response to comments, the NRC concluded that only 
some minor changes to the draft regulatory analysis were necessary, 
corresponding to some minor procedural changes in the final rule. The 
regulatory analysis is available for inspection in the NRC Public 
Document Room, 2120 L Street, NW. (Lower level), Washington, DC 20555-
0001. Single copies of the analysis may be obtained from Alan K. 
Roecklein, Office of Nuclear Regulatory Research, U.S. Nuclear 
Regulatory Commission, Washington, DC 20555-0001, telephone (301) 415-
6223.

Regulatory Flexibility Certification

    In accordance with the Regulatory Flexibility Act of 1980, (5 
U.S.C. 605(b)), the Commission certifies that this rule will not have a 
significant economic impact on a substantial number of small entities. 
This final rule only impacts NRC licensees with emissions of 
significant quantities of radioactive material who would be required to 
report the exceedance to the NRC. It will relieve licensees from the 
unnecessary burden of dual regulation. The level of air emissions from 
NRC-licensed facilities has historically been well below the NRC dose 
limit and except for a few unusual cases, readily met the EPA standard.

[[Page 65127]]

Backfit Analysis

    The NRC has determined that the backfit rule, 10 CFR 50.109, does 
not apply to this final rule because it does not apply to power reactor 
licensees, and therefore, a backfit analysis is not required for this 
final rule because these amendments do not involve any provisions which 
would impose backfits as defined in 10 CFR 50.109(a)(1).

List of Subjects In 10 CFR Part 20

    Byproduct material, Criminal penalties, Licensed material, Nuclear 
materials, Nuclear power plants and reactors, Occupational safety and 
health, Packaging and containers, Radiation protection, Reporting and 
recordkeeping requirements, Source material, Special nuclear material, 
Waste treatment and disposal.

    For the reasons set out in the preamble and under the authority of 
the Atomic Energy Act of 1954, as amended, the Energy Reorganization 
Act of 1974, as amended, and 5 U.S.C. 553, the NRC is adopting the 
following amendments to 10 CFR Part 20.

PART 20--STANDARDS FOR PROTECTION AGAINST RADIATION

    1. The authority citation for Part 20 continues to read as follows:

    Authority: Secs. 53, 63, 65, 81, 103, 104, 161, 182, 186, 68 
stat. 930, 933, 935, 936, 937, 948, 953, 955, as amended, sec. 1701, 
106 Stat. 2951, 2952, 2953 (42 U.S.C. 2073, 2093, 2095, 2111, 2133, 
2134, 2201, 2232, 2236, 2297f); secs. 201, as amended, 202, 206, 88 
stat. 1242, as amended, 1244, 1246 (42 U.S.C. 5841, 5842, 5846).

    2. In Sec. 20.1003, the definition of Constraint is added to read 
as follows:


Sec. 20.1003   Definitions.

* * * * *
    Constraint (dose constraint) means a value above which specified 
licensee actions are required.
* * * * *
    3. In Sec. 20.1101, paragraph (d) is added to read as follows:


Sec. 20.1101   Radiation Protection Programs.

* * * * *
    (d) To implement the ALARA requirements of Sec. 20.1101 (b), and 
notwithstanding the requirements in Sec. 20.1301 of this part, a 
constraint on air emissions of radioactive material to the environment, 
excluding Radon-222 and its daughters, shall be established by 
licensees other than those subject to Sec. 50.34a, such that the 
individual member of the public likely to receive the highest dose will 
not be expected to receive a total effective dose equivalent in excess 
of 10 mrem (0.1 mSv) per year from these emissions. If a licensee 
subject to this requirement exceeds this dose constraint, the licensee 
shall report the exceedance as provided in Sec. 20.2203 and promptly 
take appropriate corrective action to ensure against recurrence.
    4. In Sec. 20.2203 the section heading is revised, a new paragraph 
(a)(2)(vi) is added, and paragraphs (b)(1)(iv) and (b)(2) are revised 
to read as follows:


Sec. 20.2203  Reports of exposures, radiation levels, and 
concentrations of radioactive material exceeding the constraints or 
limits.

    (a) * * *
    (2) * * *
    (vi) The ALARA constraints for air emissions established under 
Sec. 20.1101(d); or
    (b) * * *
    (1) * * *
    (iv) Corrective steps taken or planned to ensure against a 
recurrence, including the schedule for achieving conformance with 
applicable limits, ALARA constraints, generally applicable 
environmental standards, and associated license conditions.
    (2) Each report filed pursuant to paragraph (a) of this section 
must include for each occupationally overexposed \7\ individual: the 
name, Social Security account number, and date of birth. The report 
must be prepared so that this information is stated in a separate and 
detachable part of the report.
---------------------------------------------------------------------------

    \7\ With respect to the limit for the embryo-fetus 
(Sec. 20.1208), the identifiers should be those of the declared 
pregnant woman.
---------------------------------------------------------------------------

* * * * *
    Dated at Rockville, Maryland, this 3rd day of December, 1996.

    For the Nuclear Regulatory Commission.
John C. Hoyle,
Secretary of the Commission.
[FR Doc. 96-31221 Filed 12-9-96; 8:45 am]
BILLING CODE 7590-01-P