[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
_______________________________________________________________________
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