Information Notice No. 97-04: Implementation of a New Constraint on Radioactive Air Effluents
NUCLEAR REGULATORY COMMISSION
OFFICE OF NUCLEAR MATERIAL SAFETY AND SAFEGUARDS
WASHINGTON, D.C. 20555
February 24, 1997
NRC INFORMATION NOTICE 97-04: IMPLEMENTATION OF A NEW CONSTRAINT ON
RADIOACTIVE AIR EFFLUENTS
All materials, fuel cycle, and non-power reactor licensees.
The U.S. Nuclear Regulatory Commission (NRC) is issuing this information notice to
alert addressees to a recent change in the regulations contained in NRC's 10 CFR Part
20, "Standards for Protection Against Radiation." This change affects all NRC
licensees other than nuclear power reactor licensees. It is expected that recipients
will review the information for applicability to their facilities and consider actions, as
appropriate, to ensure compliance. However, suggestions contained in this
information notice are not NRC requirements; therefore, no specific action nor written
response is required.
Description of Circumstances
The Environmental Protection Agency (EPA) promulgated, in 1989, a regulation that
placed a limit on the amount of radioactive material that may be released to the air in
unrestricted areas by NRC licensees, including Agreement State licensees. This
regulation, which was contained in EPA's 40 CFR Part 61, Subpart I, required
licensees to limit their emissions of radioactive materials to the air so that no member
of the public would receive an effective dose equivalent over 0.1 mSv (10 mrem) in a
year. It also required licensees to submit an annual report to EPA if the dose
exceeded 0.01 mSv (1 mrem/yr). The Subpart I limit was in addition to the already
existing limit on effluents in NRC's 10 CFR Part 20, which restricted the dose to any
member of the public to 1 mSv (100 mrem) in a year. It should be noted that EPA's
limit applied only to air emissions, whereas NRC's limit applies to all exposure
pathways, both internal and external.
To avoid regulation of the same activity, namely air emissions of radioactive materials,
by both NRC and EPA, an agreement was reached between the two agencies whereby
NRC would incorporate EPA's limit as a constraint on air emissions in its regulations
and EPA would rescind Subpart I. NRC published its proposed constraint rule in the
Federal Register on December 13, 1995 (60FR 63984), and the final notice was
published on December 10, 1996 (61 FR 65120) (copy attached). The rule became
effective January 9, 1997. EPA rescinded 40 CFR Part 61, Subpart I, on December
30, 1996 (61 FR 68971). Summary information on Subpart I, as well as the Federal
Register rescission notice, may be accessed via the Internet at
9702130212. IN 97-04
February 24, 1997
Page 2 of 3
Effective January 9, 1997, the constraint rule was incorporated into 10 CFR 20.1101,
"Radiation Protection Programs," Section 20.1101(d):
To implement the ALARA requirements of . 20.1101(b), and notwithstanding the
requirements in . 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 . 50.34a, such that the
individual member of the public likely to receive the highest dose will not be
expected to receive a total 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 excess as provided in . 20.2203 and
promptly take appropriate action to ensure against recurrence.
NRC licensees must still limit doses to members of the public to 1 mSv (100 mrem) in
a year from all sources of exposure, such as external radiation exposures as well as
internal exposures resulting from water and air effluents (10 CFR 20.1301). With
implementation of the constraint rule, the exposures resulting from air effluents are
further constrained to a level not to exceed 0.1 mSv (10 mrem) in a year. The
difference between a constraint and a limit is that exceeding a constraint level does
not necessarily result in enforcement action, whereas exceeding a limit always results
in such action.
The constraint rule does not impose any reporting requirements on licensees, except
in cases where the constraint has been exceeded. In such cases, the licensee is
required to notify NRC that the constraint was exceeded, describe the corrective
actions to be taken, and the schedule for completion of such actions to ensure that
the constraint will not again be exceeded. Enforcement action may be taken if such
reports are not filed as required by 10 CFR 20.2203, or if appropriate corrective
action is not taken to prevent recurrence. Because Subpart I has been rescinded,
licensees are no longer required to file a report with EPA if the constraint is exceeded,
or if the dose from air emissions exceeds 0.01 mSv (1 mrem) in a year, as was
required before rescission.
Acceptable methods to estimate the dose from air emissions, and thereby show
compliance, are described in Regulatory Guide 4.20, "Constraint on Releases of
Airborne Radioactive Materials to the Environment for Licensees Other than Power
Reactors," which was issued in December 1996. These methods include those that
have been in use to show compliance with the effluent limits in 10 CFR 20.1301, as
well as several screening methods that. IN 97-04
February 24, 1997
Page 3 of 3
have been approved by EPA to show compliance with 40 CFR Part 61, Subpart I.
Licensees may also propose their own site-specific methods for showing compliance,
subject to NRC approval before use.
This information notice requires no specific action or written response. If you have
any questions about the information in this notice, please contact one of the technical
contacts listed below or the appropriate regional office.
Donald A. Cool, Director
Division of Industrial and
Medical Nuclear Safety
Office of Nuclear Material Safety
Technical contacts: Cynthia Jones, NMSS John Kinneman, RI
(301) 415-7853 (610)337-5252
E-mail: email@example.com E-mail: firstname.lastname@example.org
John Potter, RII Brenda Holt, RIII
(404) 331-5571 (630) 829-9836
E-mail: email@example.com E-mail: firstname.lastname@example.org
Linda Howell, RIV
1. Federal Register Notice on the Constraint Rule .NUCLEAR REGULATORY COMMISSION
10 CFR Part 20 IN 97-04
RIN 3150-AF31 February 24, 1997
Resolution of Dual Regulation of Airborne Effluents of Radioactive
Clean Air Act
AGENCY: Nuclear Regulatory Commission.
ACTION: Final rule.
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: (1) 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 (2) 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 30 days after publication
in the Federal Register.
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.
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
\1\ Subpart I expresses dose in effectve dose equivalent (EDE).
NRC expresses dose in total effective dose equivalent (TEDE).
These terms are essentially equivalent.
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
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).
The amendments proposed on December 13, 1995 (60 FR 63984), and 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 . 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
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
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 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
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 . 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 . 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
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 (D.C. Cir. 1975).
The Commission has presumed, without deciding, that the ALARA concept in .
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
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
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
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.
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
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
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
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
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
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 judgement, 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.
Issue 9 --Exemptions
Comments: Five commenters stated that the rule should only apply to
members of the public off site. 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
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
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 . 20.1301 with the
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 . 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.
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
(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
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@example.com; 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.
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.
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 . 20.1003, the definition of Constraint is added to read as
. 20.1003 Definitions.
* * * * *
Constraint (dose constraint) means a value above which specified licensee
actions are required.
* * * * *
3. In . 20.1101, paragraph (d) is added to read as follows:
. 20.1101 Radiation Protection Programs.
* * * * *
(d) To implement the ALARA requirements of . 20.1101 (b), and
notwithstanding the requirements in . 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 . 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 .
20.2203 and promptly take appropriate corrective action to ensure against
4. In . 20.2203 a new paragraph (a)(2)(vi) is added and paragraphs
(b)(1)(iv) and (b)(2) are revised to read as follows:
. 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
. 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 overexposed7 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
\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.
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