Information Notice 1997-04, Implementation of a New Constraint on Radioactive Air Effluents

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Implementation of a New Constraint on Radioactive Air Effluents
ML031050386
Person / Time
Site: Beaver Valley, Millstone, Hatch, Monticello, Calvert Cliffs, Dresden, Davis Besse, Peach Bottom, Browns Ferry, Salem, Oconee, Mcguire, Nine Mile Point, Palisades, Palo Verde, Perry, Indian Point, Fermi, Kewaunee, Catawba, Harris, Wolf Creek, Saint Lucie, Point Beach, Oyster Creek, Watts Bar, Hope Creek, Grand Gulf, Cooper, Sequoyah, Byron, Pilgrim, Arkansas Nuclear, Three Mile Island, Braidwood, Susquehanna, Summer, Prairie Island, Columbia, Seabrook, Brunswick, Surry, Limerick, North Anna, Turkey Point, River Bend, Vermont Yankee, Crystal River, Haddam Neck, Ginna, Diablo Canyon, Callaway, Vogtle, Waterford, Duane Arnold, Farley, Robinson, Clinton, South Texas, San Onofre, Cook, Comanche Peak, Yankee Rowe, Maine Yankee, Quad Cities, Humboldt Bay, La Crosse, Big Rock Point, Rancho Seco, Zion, Midland, Bellefonte, Fort Calhoun, FitzPatrick, McGuire, LaSalle, Fort Saint Vrain, Shoreham, Satsop, Trojan, Atlantic Nuclear Power Plant  Entergy icon.png
Issue date: 02/24/1997
From: Cool D
NRC/NMSS/IMNS
To:
References
-RFPFR IN-97-004, NUDOCS 9702130212
Download: ML031050386 (23)


i

UNITED STATES

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

Addressees

All materials, fuel cycle, and non-power reactor licensees.

purpose

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 mremlyr). 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 I 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 bptween 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

egaiter on December 13, 1995 (60 FR 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 Ragister rescission. notice, may be

accessed via the Internet at http:/Ivww.epa.gov/radiation/eshaps.

I q 'q?-oo(

foR 97o0z 9 u,)

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IN 97-04 February 24, 1997 Page 2 of

Discussion

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 Ks 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 I 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 Ucensees Other than Power Reactors," which was issued in

December 19961. 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

Single copies of regulatory guides may be obtained free of charge by writing the Office of

Administration, Attention: Distribution and Services Section, U.S. Nuclear Regulatory

Commission, Washington DC 20555-0001; or by fax at (301)415-2260.

K>

IN 97-04 February 24, 1997 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

and Safeguards

Technical contacts: Cynthia Jones, NMSS John Kinneman, RI

(301) 415-7853 (610)337-5252 E-mail: cgj@nrc.gov E-mail: jkd@nrc.gov

John Potter, RII Brenda Holt, RIII

(404) 331-5571 (630) 829-9836 E-mail: jpp@nrc.gov E-mail: bjh@nrc.gov

Linda Howell, RIV

(817) 860-8213 E-mail: llh~nrc.gov

Attachments:

1. Federal Register Notice on the Constraint Rule

2. List of Recently Issued NMSS Information Notices

3. List of Recently Issued NRC Information Notices

rP;L4 act,

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Attachment 1 IN 97-04 February 24, 1997 (Federal Register: December 10, 1996 (Volume 61, Number 238)]

(Rules and Regulations] [Page 65119-65127]

From the Federal Register Online via GPO Access [wais.access.gpo.gov]

Page 65119

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

[(Page 6512011

NUCLEAR REGCLATORY COWISB 0IN

10 CPR Part 20

RIN 3150-AP31 Resolution of Dual Regulation of Airborne Effluents of

Radioactive Materials; Clean Air Act

AGECWY: Nuclear Regulatory Co ission.

ACTION: Final rule.

SU4MMRY: The Nuclear Regulatory Commission 18 amending its regulations

to establish a constraint of 10 mrem (0.1 mSv) per year total effective

dose equivalent (TIDE) 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

CPR Part 61 for NRC licensed facilities (other than power reactors) and

Agreement State licensees, thereby relieving these licensees from

unnecessary dual regulations.

K> .K-j

Attachment 1 IN 97-04 EFFECTIVE DATE: This rule will become effective January 9, 1997. February 24. 1997 FOR FURTHER INFORMATION

CONTACT

Alan K. Roecklein, Office of Nuclear Regulatory Research, U.S. Nuclear Regulatory Commission, Washington, DC

20S55-0001, telephone (301) 415-6223.

SUPPLEMENTARY INFORMATION:

Background

The EPA promulgated National Emission Standards for Hazardous Air

Pollutants (NBSHAPs) 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.cSUP>l 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 N

(addressing operating mill tailings piles). EPA rescinded Subpart T for

NRC licensees after Appendix A to 10 CFR Part 40 was amended by the

Com-ission to conform to changes EPA issued to 40 CPR Part 192. Subpart

Wstill applies to NRC licensees. Because Radon-222 is adequately

addressed in 10 CFR Part 40, Appeadix A, and other provisions of 10 CFR

Part 20, it is not covered in this final rulemaking.

____-______________________________________________

\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.

___________________________________________________

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

Comission (or an Agreement State) is required to be promulgated

under this section if the Administratot determines, by rule, and

after consultation with the Nuclear Regulatory Comnission, that the

regulatory program established by the Nuclear Regulatory Comission

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 imediately 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 4S additional facilities

that were selected because of their potential for air emissions

resulting in significant public exposures. EPA found that 7S 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 prograw under the Atomic Energy Act

'. J KIJ

Attachment 1 IN 97-04 provides an ample margin of safety to protect public health (57 FR February 24. 1997

56880; December 1, 1992). adequacy of

However, EPA continued to express concern regarding the will

the measures to assure that future emissions from NRC licensees

will provide an ample margin of safety. The stay

not exceed levels that

on Subpart I expired on November 15, 1992, and Subpart I

became

the EPA

effective on November 16, 1992. Subsequently, in July of 1993, that time

determined that th-re was insufficient basis at

Administrator licensed

to rescind Subpart I. Consequently, NRC and Agreement State of

facilities were subject to dual regulation of airborne effluents

radionuclides under both the AMM and the CAA, including regulatory

State).

oversight by EPA (or authorized State) and NRC (or Agreement to NRC

NRC licensees subject to EPA's Subpart I are also subject

dose limits for members of the public contained in 10 CFR Part 20, of

Subpart D, entitled "Radiation Dose Limits for Individual Members that

the Public"' (Subpart D). Under Subpart D, licensees shall ensure per

doses to members of the public are less than 100 mrem (1.0 mSv)

sources

year from all pathways (including airborne effluents) and all Subpart B,

associated with the licensee's operation. In addition, under

ensure that

entitled "Radiation Protection Programs, licensees must

doses to members of the public be kept as low as is reasonably

licensee

achievable (ALARA). Based on the studies conducted by EPA and to

reporting of doses to members of the public from airborne effluents

0.1 mSv) per year to the

EPA, it is evident that less than 10 mrem(

maximally exposed member of the public from airborne radioactive

effluents to the environment is reasonably achievable. keep

NRC power reactor licensees subject to 10 CFR 50.34a must with

doses to members of the public from airborne effluents consistent

the numerical guidelines in Appendix I to 10 CFR Part 50. These

from

licensees have reported estimated doses to members of the public Based on

air emissions well below the Subpart I value for many years.

air

the combination of a continuing regulatory basis for reduced NRC program

emissions and documented proof of the effectiveness of the

for these licensees, EPA rescinded Subpart I for power reactors

licensed by NRC (60 FR 37196; September S, 1995).

Amendments

and

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

[(Page 651211]

mSv) per

finalized in this rule establish a constraint of 10 mrem (0.1 effluents

year TEDS to members of the public from airborne radioactive power

to the environment from NRC-licensed facilities, other than These

reactors, as a part of its program to maintain doses ALARA. ALAUM

amendments codify numerical values for NRC's application of other than

guidelines for radioactive air emissions from its licensees, already been

power reactors. For power reactors, ALARA guidelines have licensing

established within 10 CPR Part So and existing facility

are

conditions. These final amendments ensure that air emissions the

maintained at very low levels and, taking into consideration

licensees. This

elimination of dual regulation, at some reduced cost to and the NRC's

action brings consistency between the EPA's dose standard

and is expected to be the final step in providing

ALARA application, NRC-licensed

EPA with the basis to rescind Subpart I as it applies to

facilities other than power reactors. NRC has been working in 40

cooperatively with EPA to achieve rescission of EPA's standards CAA. EPA

CFR Part 61, Subpart I, under Section 112(d)(9) of the

I, on

published a proposed rescission of 40 CFR Part 61, Subpart published a

December 1, 1992 (57 FR 56877). On September 28, 1995. EPA

on

notice in the Federal Register reopening the comment period this effort is

rescission of Subpart I (60 FR 50161). The objective of

that provide no incremental

to eliminate duplicative regulations

benefit in terms of public and environmental protection. basis for

The regulatory framework that NRC is providing as a in 10 CFR

rescission of EPA's Subpart I consists of the requirement mrem (1.0 MSv)

Part 20 to limit doses to members of the public to 100

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Attachment 1 IN 97-04 I

to members of the February 24. 1997 per year, and the requirement to constrain doses materials to the public from airborne effluents of radioactive to 10 mrem '0.1 mSv) per

envir~.ment from a single licensed operation

year. to make or

Currently, under Sec. 20.1501 licensees are torequired comply with the

cause to be made surveys that may be necessary be made available to

regulations in 10 CFR Part 20. This data would

or measures a dose

inspectors upon request. If the licensee estimates than 10 mrem (0.1 to the nearest resident from air erissions greater to report the dose to NRC

mSv) per year, the licensee would be required the circumstances that

in writing within 30 days, which would include

per year dose, a description

led to the greater than 10 mrem (0.1 mSv) taken or proposed to take to

of the corrective steps the licensee had

ensure that the constraint is not again the exceeded, a timetable for

implementing the corrective steps, and expected results. Records of

the results of measurements and calculations needed to evaluate the

to the environment will still be

release of radioactive effluents

required pursuant to 10 CPR 20.2103(b)(4). result in a Notice of Violation

Exceeding this constraint will not needed for adequate protection of

(NOV) as would be the case if a limit

exceeded. In the case of the constraint

public health and safety were when (1) a licensee fails to

rule, an NOV will be issued only if and

dose from airborne effluent releases from

report an actual or estimated value; or (2) if a licensee

a facility that has exceeded the constraintmeasures intended to prevent

fails to institute agreed upon corrective

would result in

further airborne effluents in excess of those which

doses exceeding the constraint level.

The rule applies to airborne effluents daughters, of radioactive materials to

from all NRC

the environment, other than Radon-222 and reactors are exempt from this

licensees except power reactors. Power

are already required, under 10 CFR 50.34a, to

rule because they to be employed for keeping

identify design objectives and the means

doses to members of the public from airCPR effluents ALARA in their

license application. Appendix I to 10 Part So contains the

numerical guidelines to meet this requirement.

Response to Comments

Fifty-seven individuals and organizations provided written comments

and Draft Regulatory Guide DG-8016. Among the 57 on the proposed rule were professional organizations, coamienters, 24 were licensees, seven the public, and five were

five were States, 16 were members of

environmental organizations. Because included many letters commenting on the

Guide DG-0016 also comments on the rule, Draft Regulatory in developing the final rule.

these comments were also considered

Issue 1--Proposed Rule Approach

and organizations

CoAments: A total of thirty-one individuals

on the basis for the rule. Five commentere agreed with the

commented commented that the rule

approach and need for the constraint. Four I should remain in

should not be finalized and that EPA's Subpart

coamenters stated that existing NRC programs

effect. Twenty-two that the constraint was not

provided an ample margin of safety and

of these, seven agreed that the constraint was

needed. However, alone.

preferable to dual regulation or Subpart I are adequate to protect

Those coammenting that existing NRC program

on doses from air emissions. Two- the public cited the two EPA studies forward with the

to going

thirds of these commenters were opposed not needed and that licensee

constraint because they believed it was

not be justified given the expectation that

and regulator costs could commenters

would not be reduced. These

risk to public health and safety to provide sufficient basis

encouraged NRC to continue working with EPA of an equally

the imposition

for rescission of Subpart I without stated that the risk was

unnecessary regulation. A few commenters

because excessively conservative

considerably less than estimated commenters compared the

were used by EPA. A few

calculational methods variability in background or

10 mrem (0.1 mSv) per year constraint to

that the dose and the

doses from commercial air traffic as evidence

Attachment 1 IN 97-04 February 24. 1997 burden reduction and single- risk is trivial. Seven commenters cited that the constraint was reasons for agreeing

agency oversight as the Subpart I alone.

pre:zrable to dual regulation or EPA's as a less protective standard, Coamenters opposed to the constraint

upon a voluntary program (ALARA)

stated that the constraint was based the public. one commenter

and, as such, was not adequate to protect

measurements and

stated that NRC does not perform confirmatory adequate.

therefore, NRC jurisdiction was not

to develop a basis upon

Response: NRC and EPA have been working EPA has stated that there

which dual regulation could be eliminated.

finding that NRC's program is

are two necessary components to any safety of the public. The first is

sufficient to protect the health and

are below 10 mrem (0.1 mSv) per

evidence that doses from air emissions has been demonstrated through the

year to a member of the public. This

of actual air emissions.

two studies by EPA and by licensee reporting ensure that doses remain at this

The second component is a program to

requiring licensees to maintain

level. In the absence of rulemaking (0.1 msv) per year, EPA would

doses to levels of no more than 10 mrem

would continue.

not rescind Subpart I and dual regulationwas formed in 1959, to provide

The Federal Radiation Council (FRC)

Federal policy regarding radiation

recommendations to the President for1960, FRC set forth basic principles

matters that affect health. In May

for

((Page 6512211 The council was abolished in

protection of both workers and the public.to the EPA Administrator. In

1970 when its functions were transferred for new Federal guidance

1981, EPA published proposed recommendations Reagan approved

for occupational exposure. In 1987, President for new "Radiation Protection

recommendations by the EPA Administrator Exposure.'" EPA has not

Guidance to Federal agencies for Occupational for the public. A working group

yet issued recommendations on limits

Federal agencies and experts

comprised of representatives from affected been developing these

on radiological health matters has

expects to provide them during

reco1mendations for several years and

the next year. Radiological Protection

In 1977, the International Council on of the International

(ICRP) issued its Report No. 26 "Recommendations

in 1977. These recommendations

Council on Radiological Protection" members of the public should not

concluded that the average doses to

a limit of 500 mrem (5.0 mSv)

exceed 100 mrem (1.0 mSv) per year with

per year to any individual. Radiation Protection and Measurements

The National Council on limits for exposure to

(NCRP) is required by Congress to recommend issued its Report No. 91, ionizing radiation. In June 1987, NCRP

to Ionizing Radiation." This

"Recolmendations on Limits for Exposure limits for both

report contains recommendations on exposure individual members of the

and

occupationally exposed individuals doses to individual members of the

public. The report recommended that

per year averaged over a

public be limited to 100 mrem (1.0 mSv)mSv) in 1 year.

lifetime, not to exceed SOO mrem (5.0 20 Standards for Protection

In 1991, NRC revised 10 CPR Part new limits for individual

Against Radiation." This revision included the ICRP and the NCRP recommended

members of the public. Though both

year, the NRC established a

limits of 500 mrem (5.0 mSv) in any one "-cause it was impractical to

limit of 100 wrem (1.0 mSV) per year

without keeping track of

control dose in terms of lifetime average 10 CFR Part 20 requires that

individual exposures. In addition, controls to maintain doses

licensees use procedures and engineering

are designed to achieve

Both the NRC and EPA regulatory programs margin of safety. The approaches

protection of the public with an ample

TEDE, requires that doses are

of the two agencies differ. NRC limits inspection program. EPA

an active

maintained ALARA, and maintains of exposure and individual

limits dose from individual pathways

to onsure that the total dose does not exceed recommended

radionuclides levels of protection.

levels. Both programs achieve similar constraint in Sec. 20.1101(d) is

NRC agrees that adoption of I'm

Attachment 1 IN 97-04 reduction in burden on February 24. 1997 preferable to dual regulation due to theagencies. Under the provisions licensees as well as State and Federal

to members of the public

of 40 CFR Part St, licensees with doses year but less than 10 mrem (0.1 mSv)

greater than 1 mrem (0.1 mSv) per

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

doses can be evaluated during routine inspections. Under

level because calculating doses should be reduced for

the final rule, the burden of

for demnsllmtrating

most licensees because the proposed guidance significantly more flexibility

compliance with 10 CFR 20.1101(d) allows

doses than the model currently used

and simpler methods for calculating These new methods for

to demonstrate compliance result with 40 CFR Part 61. and corrective

calculating doses should in fewer reporting

actions, as under EPA's Subpart Ir of

Licensees are required undercompliance Sec. 20.2103 to maintain recordslimit.

with the public dose

surveys required to demonstrate with the

Review of licensee records used to demonstrate compliance Confirmatory

part of the NRC inspection program.

public dose limit isgenerally not be useful since most licensees in this

measurements would releases.

category do not have routine ongoing effluent that believe NRC's

Finally, concerning those commenters

safe than Subpart I, Congress enacted legislation

requirements are less

comprehensively amending the Clean Air Act (CAA), which included a and

section addressing the issue of regulatory duplication between EPA

permit the EPA Administrator to

NRC in 1990. The 1990 CAA amendments at sites

rescind the CAA standards as they apply to radionuclides, if he or she finds that the

licensed by NRC, and the Agreement States, an ample margin of safety to protect

NRC regulatory program provides

public health.

focused on two general

EPA's analysis of the NRC r gulutoryofprogram the NRC regulatory program

issues: (1) whether the implementation

to protect the health and safety of

results in sufficiently low dosesof safety; and (2) whether the NRC

the public with an ample margin and thorough, and administered EPA in

program is sufficiently comprehensive protect public health in the future.

a manner that will continue to

undertook studies to determine the level of protection provided by the

that doses were sufficiently low

existing regulatory program nd found with an ample margin of

to protect the health and safety of the public will ensure that doses to

safety. The implementation of this rule

of the public from air effluents will continue to remain below

members the current

10 mrem (0.1 mSv) per year and provide evidence to EPA that

level of protection will continue.

to reduce doses, because it

The purpose of this rulemaking is not are sufficiently low. The

has already been demonstrated that doses at the low level

purpose is to ensure that doses are maintained eliminate unnecessary dual

currently achieved by NRC licensees, with the current level doses of

regulation, and reduce costs associated upon which EPA can find that

protection, by providing a basis

Subpart I.

will not increase as a result of rescission of

Issue 2--Promulgation of the Constraint as MA

who objected to the

Comments: There were a number of commenters rule. Some coementers objected

ALARA basis for the proposed constraint of operating philosophy, good

on the ground that ALmRA is a matter licensee judgment, and cannot be

radiation protection practice and dose number. Other comenters objected

translated into an enforceable cannot be

on the basis that ALARA is inherently site specific and cannot be

defined generically or thatbecause the proposed dose constraint

the constraint contemplatesfoilowed some

ALRA but must be a limit if the licensee has

enforcement actions for exceadance even

Some commenters argued that

all good radiation protection practices. benefit.

the rule cannot be ALLRA because it adds costs with no safetywith a

stated that the constraint is inconsistent

Other commenters 20 (56 FR 23360) on the use of

prior NRC decision in 10 CFR Part

-'reference levels."

Response: The Colsaion has retained an ALt A basis for the rule

term in this rule may have led to

but recognizes that its use of the concept in

some confusion. The c a ission acknowledges that the ALMA

K> K) Attachment 1 IN 97-04 February 24. 1997 which requires good radiation 10 CFR 20.1003 is an operating philosophy licensee judgement. The

of expert

protection practice and the exercise some of the factors to be

ALARA con-ept is site specific in that the court so found in York

case, as

considered may vary from case to v. NRC, 527 F. 2d 812 Committee for a Safe Environment

((Page 6512311 without deciding, that

(D.C. Cir. 1975). The Cormidesin has presumed, enforced in a particular case

the ALARA concept in Sec. 20.1003 can be

practice, but it is

so as to require a specific radiation protectionnot translate readily into a

clear that the existing regulation does will lead to enforcement

generic dose number, which, if exceeded, action. be a somewhat broader

The NRC intended the constraint rule to Atomic Energy Act of 1954, the

concept found in the governing statute, by both the ComuSiadon (e.g.,

as amended (Act). The Act, as construed Concerned Scientists v. NRC,

10 CFR 50.109) and the courts (Union of two distinct approaches to

924 F.2d 108 (D.C. Cir. 1987)), contemplates of "adequate protection must

radiological regulation. First, a level

economic cost. Second, risk

be defined and enforced without regard to with "adequate

may be reduced to a level below that associated

or property" with economic

protection' to "minimize danger to life considerations. See

cost and other factors as permissible balancing

Reactors, (53 FR 20603;

"Revision of Backfitting Process for Power Section 161b of the Act

June 6, 1988). It is important to note that

generic requirements

authorizes the Comission to adopt and enforce regulations (e.g., 10 CFR 50.63)

using either approach. Many recent NRC

under the second

have been directed at incremental risk reduction

or backfit analysis which

approach based on a generic regulatory

costs and safety backfits.

considered and balanced economic and other "limits"' because they

These "minimize danger regulations provide

enforceable against licensees.

establish generic requirements directly ALARA regulations because cost, However, in a broad sense they are also identified in 10 CFR 20.1003 feasibility, and other relevant factors

are evaluated. the use of ALARA in 10 CFR

Viewed in its larger statutory context, approach to radiological

20.1003 is one means to implement the second can also be part of

regulation. However, other similar requirementsin 10 CFR 20.1003 may not

this second approach. While the ALARA concept dose requirement, other

be consistent with a generic enforceable are appropriate.

concepts of ALARA premised on generic considerations dose requirement based o..

This concept of ALKRA as a broadly applicable

of health and safety, feasibility, and

a generic weighing and balancing limits on nuclear power

other factors is the basis for the longstandingI, and is the basis for

reactor emissions in 10 CPR Part so, Appendixa limit in the sense that

the constraint rule. The ALARA rule imposes but it is not a limit in the

exceedance will lead to corrective action, a violation of any

sense that exceedance per se would constitute only when a licensee fails

regulatory requirement. A violation occurs

appropriate corrective

to report an exceedance or fails to take if compliance were needed to

actions. A limit would be appropriate

and safety. In this case, ensure adequate protection of public health that currently afforded levels

the constraint is needed only to ensure

provide the basis for

of protection are not reduced. This will EPA.

rescission of 40 CPR Part 61, Subpart I by cannot be based on ALARA

Thus, to say that the constraint rule

a narrow concept of

because it is in effect a limit.'" interchanges If a broad definition is

AULARM" with a broad concept of -limit.' as both ALARA and a

used, the constraint rule withstands scrutiny Energy Act and general

Atomic

limit. In the statutory context of the constraint rule is a limit based

principles of administrative law, the rule is not a limit

on generic ALMA considerations. The constraint rule is something

protection and the constraint

needed for adequate particular ALMA concept

more than a narrow translation of the

20.1003. The term 'constraint'" was used for the

contained in 10 CFR of ALARA and the limit

concepts

rule to avoid confusion with the narrow

employed in radiation protection discussion.

Three matters must be addressed:

Attachment 1 IN 97-04 t- February 24. 1997 on ALARA because it (1) The comment that the rule cannot be based benefit;

willresult in increased cost with no safety

the dose constraint

(2) The problem of the licensee who cannot meet and

despite using all good radiation protection practices;

inconsistent Comission discussion of reference

(3) The allegedly

levels in a recent revision to 10 CFR Part 20.

the first comment.

The Commismion disagrees with the premise of that all of

with the Commission's conclusion

There was no disagreement a level of control

the licensees affected by the rule are achieving year level and so

10 mrem (0.1 mSv) per

such that doses are below the of radiation

there is no factual dispute over whether this level

EPA'S rescission

protection is readily achievable. The final rule and requirements will

of its Clean Air Act emission limits and related

cost savings to licensees. The NRC

result in a significant net are likely to be

acknowledges that the positive direct health effects given the current

small and possibly nonexistent in the near future, of controls. However, the rule can be said to offer a small, but

level it will prevent a

positive, net health and safety benefit in that public if Subpart I

decrease in the level of protection afforded the constraint. Under the the

were rescinded in the absence of a rule like on a small

ALARA concept, it is appropriate to base a requirement are also likely.

positive health and safety benefit when cost savings

subject to the rule will

The NRC does not expect that any licensee of the public from

be unable to demonstrate that doses to members

environment are less

releases of airborne radioactive materials to the case that this dose is

than 10 mrem (0.1 mSv) per year. In the unlikely

some temporary

exceeded or is projected to be exceeded, due to the licensee to

circumstances or lapse in controls, the NRC expects

are necessary (if any) to protect

take whatever corrective actions further

public health and safety, to report the dose, to recommend

and take those corrective actions

corrective actions if necessary, approve corrective

agreed upon with NRC. NRC staff will review and to reduce airborne

actions to ensure that they are appropriate

sufficiently to comply with the constraint in the future. In

emissions adequate corrective

the unlikely case that a licensee is unable to take constraints, these

actions, because of limits in technology or cost

basis.

issues can be addressed in the future on a case-by-case this rule is not the

used in

The application of the ALARA principle was rejected by the

same as the concept of reference level which

recently revised. Commenters on the

Comission when 10 CFR Part 20 was reference levels

CYR Part 20 objected to the use of

1991 revision to 10 as adequate protection

because they were implemented exactly tle same

adopt reference levels

limits. For that reason, the Comisia on did not is different

in the 1991 revision. Implementation of the constraint

a limit because exceeding the constraint is not a violation, than such dose and take corrective

and only requires the licensee to report the

actions to reduce future doses.

Issue 3--Whether the Constraint Is Actually a Limit

the constraint is

Comments: Nine comments were received on whetherthe constraint was

or should be a limit. Two commenters believed that

with the term

no different than a limit. one commenter agreed

coaaenters expressed concern that the constraint was

constraint. Three

an inappropriate relaxation of requirements.

[(Page 6512411 de facto limit

Those commenting that the constraint was a

requirements to indicate that a second exceedance of

interpreted the and therefore the

the constraint would result in enforcement action

is a limit. Three commenters indicated that the rule should

constraint constraint was less

be a strict limit. They expressed concern that the

protective than EPA requirements.

is needed to protect

Response: If a licensee exceeds a limit that action. If a

the NRC may take immediate enforcement

health and safety, be required to notify

licensee exceeds a constraint, the licensee will

that may necessary to protect public health

NRC, take any actions NRC staff

fun.. er corrective actions that

and safety, and implement any

Attachment 1 IN 97-04 February 24. 1997 excess of the agrees are adequate to prevent further doses toinreport a measured or

constraint. However, if the licensee failed

to KRC or failed to

calculated dose in excess of the constraint agreed upon, enforcement

implement appropriate corrective actions as

an adequate

action would be expected. This is because, unlike to provide adequate

protection limit, the constraint is not needed

protection of public health and safety.

The NRC does not agree that the constraintI and is less protective than

the NRC constraint

current EPA requirements. Both EPA's Subpart doses to members of

require licensees to take actions to ensure that

not exceed 10 mrem (0.1 msv) per year from ambient air

the public do facilities to ensure that

emissions. NRC routinely inspects licensed

of the public that

air effluents do not result in doses to members The inspection and

exceed the requirements in 10 CFR Part 20.

enforcement program will be amended as a result of this final rule to

to demonstrate compliance with the

review licensee records used

constraint.

Issue 4--Citizen Suits

the constraint

Comments: Three commenters opposed finalization of licensee who

citizen rights to sue a

on the basis that it forfeits

exceeds the constraint. 2.206 provide the

Response: The Commissiones regulations in 10 CFR enforcement action

public with the right to petition the NRC to take

for a violation of the ComisiLon's regulations.

against a licensee

This would include the final constraint rule.

Issue 5--Agreement State Compatibility

Comments: Four commenters addressed the proposal that the

2, constraint be a Division 2 matter of compatibility. Under Division

States could adopt similar or more stringent be requirements. Three

commenters agreed that this rule should not codified as a Division 2 as a Division 1 matter of compatibility. Under

requirement, but rather regulations that were

Division 1, the States would be required to adopt

These commenters believed that if stricter

essentially identical. licensees would be

standards were permitted, reactor and non-reactor

requirements and certain practices, such as nuclear

under different

noted that because this

medicine, could be jeopardized. one commenter 20.1301 and would be a

is really a limit, it should be under 10 CPR

Division 1 matter of crmpatibility. Another for coamenter stated that NRC

should have provided a greater opportunity State involvement in

as a division 2 rule, Agreement States would

this rulemaking, and that rule.

have to spend scarce resources to develop a compatible

116 of the Clean Air Act specifies that nothing

Response: Section that are more

precludes States from imposing air emission requirements

developed by EPA. Section 116(d)(9), which

stringent than those of safety determination

contains the provisions related to EPA's marginthat: 'Nothing in this

for NRC or Agreement State licenses, specifies of any State or political

subsection shall preclude or deny the right

or limitation

subdivision thereof to adopt or enforce any standard is more stringent than the

respecting emissions of radionuclides which

7411 of this title or

standard or limitation in effect under Section that this provision clarifies

this section. - The Coamission believes

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.

comment concerning involvement of the Agreement

With regard to the routinely reported its

states in the development of this rule, NRC has

adequate basis upon which EPA could rescind

progress on providing an States (OAS) and the

Subpart I to both the Organization of Agreement

Conference of Radiation Control Program Directors (CRCPD) at each of

were consulted extensively

their annual meetings. The Agreement States There were extensive

on this issue over the last several years.

and with the

discussions of the concept with the individual States

Executive Board of the OAS.

Reports

Issue 6--Demographic Information Contained in Required

Attachment i

IN 97-04 February 24. 1997

.... wents: Seven commenters addressed the application of Lhe 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 aid 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.

H[Page 6512S]5 Issue 9--Exemptions

Comments: Five commenters stated that the rule should only apply to

members of the public ofosite. They cited the EPA's Subpart I

requirement to calculate dose to the nearest resident or offeite

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-B016 will be revised to

indicate that the dose limit is to be calculated or measured at the

nearest resident or individual offaite 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 wills 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.

K> Attachment 1 IN 97-04 IFebruary 24, 1997 Response: Subpart Idoes not apply to disposal at facilities regulated under 40 CFR Part 191, Subpart B, or to any uranium mill

46CFR Part 192. The

tailings pile after it has been disposed of under licensed materials to

constraint applies to airborne effluents of onlywill be changed to

the environment. Draft Regulatory Guide DG-S016 licensed facilities or

clarify that windblown particulates from other in the calculation of

unlicensed materials do not need to be considered the constraint.

doses used to demonstrate compliance with

from patients

Comments: Four commenters stated that air emissions

should be exempted from this rule.

for a recent

Response: The regulatory impact analysis (NUREG-1492) to patients who

potential doses from exposure

NRCrulemaking analyzed This

were released after administration of radiopharmaceuticals.

analysis concluded that internal doses frompatient inhalation of radioactive

are trivial. For

materials in the exhaled air of a released compliance with

licensees using an inventory approach to demonstrating

code, there is no need to account

the rule, such as the COMPLY computer released to the air

specifically for the materials that might be

by patients. The Regulatory Guide

through respiration or transpiration from patients do not

will make it clear that dose from air emissions

of dose used to

need to be specifically addressed in the calculation

demonstrate compliance with the constraint.

addition to Rn-222, all

Comments: Four commenters stated that in be excluded.

daughters produced after release should also and any daughters

Response: EPA's Subpart I exempts both Rn-222 types of releases are

produced after release of Rn-222 because these

to licensed activities. The proposed rule was

normally not attributable The rule language has

I.

not intended to be more stringent than Subpart

been changed to reflect this exemption.

addition to Rn-222, Comments: Two comaienters recommended that in One commenter stated

Rn-220 and its daughters should also be exempted.

to this erroneous omission from

that it was an EPA oversight that led

the final Subpart I.

to licensed activities.

Response: Rn-220 is normally attributablefrom consideration in the

EPA does not exempt Rn-220 or its daughters

with Subpart

dose calculations in support of demonstrating compliance led to the erroneous

I. The commenter's suggestion that an oversight

incorrect, and Rn-220

omission of this exemption from Subpart I is that are used to

should not be excluded from the calculations

demonstrate compliance with the constraint. addition to sealed

Comments: Six commenters requested that in from the rule.

sources, sealed containers should also be excluded

Paragraph 2(a) of Appendix D to 40 CFR Part 61 states:

Response: remain unopened, and have

Radioactive materials in sealed packages that not be included in the

not leaked during the assessment period should

because any package

calculations. " Subpart I exempts sealed packages, effluents. When

to airborne

that has remained sealed cannot contribute during the year is

a total inventory of licensed materials possessed

is unnecessary to include materials

used to model potential doses, it The Regulatory

that could not have contributed to airborne effluents.

issue.

Guide will provide further guidance on this

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

Comments: Three commenters stated that 10 urem (0.1 mSv) per year

that although 10 mrem (0.1 was not measurable. one commenter stated not easily measurable.

BSv)per year might be easily achievable, it is

to 1 microR (0.01 Another stated that the exposure rate corresponds accurately.

micro-Sv) per hour and cannot be measured

provides several methods

Response: Draft Regulatory Guide DG-8016 and only one of the

for demonstrating compliance with the constraint, measurement at the receptor

methods described would require direct to the emission

is not practical due

location. If this method there are other options

characteristics of the radionuclide releases, do not require a direct

cited in Draft Regulatory Guide DQ-8016 that the constraint.

measurement to demonstrate compliance with

Issue 11--Scope of the Rule

K-.) Attachment 1 IN 97-04 February 1997 Comments: One commenter stated that if there must be a constraint, Page 12 of24. 15 it should apply to all licensees, including power reactor licensees. 9 Rz:ponse: 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--ocation of Constraint in NRC Regulations

The Com iasion 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 comnenters 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 msx) per year.

((Page 6512611

Agreement State Compatibility

The Coriasson 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

IRC. 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 Cami-- don

reviews Agreement State programs to ensure that adequacy and

compatibility of the State Program is maintained. The Comission hasnot

also approved procedures to suspend or terminate programs that are

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 to

constraint applies only to release of airborne radioactive effluents

the environment and, thus, dose to the nearest resident, offaite

business or school, is to be constrained.

In addition, the following cl-nqes will be made to Draft Regulatory

i - tAttachment 1 IN 97-04 February 24. 1997 Guide DG-8016: a potential

(1) An inventory of radioactive materials used to model mcterials

radioactive

dost. to a member of the public need not include throughout the

in sealed containers that have remained sealed

compliance period. from patients does

(2) Airborne emissions of radioactive materials already been included

not need to be considered if the materials have

in the site inventory. comment

TLe Regulatory Guide was issued in draft for public guide will be

concurrent with the proposed rule. The final regulatory

available by the effective date of this rule.

Conforming Amendments To NRC's Enforcement Policy

By separate notice in the Federal Register, Procedures the Commission is

"General Statement of Policy and for NRC

modifying its the new

Enforcement Actions" (Enforcement Policy), to address

Iv violation of

regulation, and to provide an example Severity Level when the Enforcement

the constraint. This change will also be reflected

in the next revision of NUREG-1600.

Policy is reprinted in its entirety

Act

Small Business Regulatory Enforcement Fairness

Enforcement

In accordance with the Small Business Regulatory this action is not a

Fairness Act of 1996, the NRC has determined that

Office of

major rule' and has verified this determination with the Budget.

of Management and

Information and Regulatory Affairs, Office

Finding of No Significant Environmental Impact

Environmental

The Comission has determined under the National regulations in Subpart A

Policy Act of 1969, as amended, and the NRC's

if adopted, would not be a major

of 10 CPR Part 51, that this rule, of the human

Federal action significantly affecting the quality

statement is not

environment and therefore, an environmental impact any significant

required. This action is not expected to have provide equivalent

environmental impact because the programs will materials to the

protection. Also, airborne effluents of radioactive The changes to the final rule

environment are not expected to increase.

compliance as well as

are to the procedural methods for demonstrating assessment and

licensing and inspection procedures. The environmental

which this determination is based

finding of no significant impact on for a fee at the NRC

are available for inspection and photocopying (Lower Level), Washington, DC.

Public Document Room, 2120 L Street NW.

Paperwork Reduction Act Statement

requirements that are

This final rule amends information collection U.S.C. 3501 et.

subject to the Paperwork Reduction Act of 1995 (44 were approved by the Office of Management and

seq.). These requirements

Budget, approval number 3150-0014. of information is

Theipublic reporting burden for this collection the time for

including

estimated to average 80 hours9.259259e-4 days <br />0.0222 hours <br />1.322751e-4 weeks <br />3.044e-5 months <br /> per response, sources, gathering and

reviewing instructions, searching existing data

and reviewing the

maintaining the data needed, and completing aspect of this

collection of information. Send comments on any

suggestions for further reducing

collection of information, including Branch (T-6 Information and Records Management

this burden, to the DC 20555-0001, or

P33), U.S. Nuclear Regulatory Conission, Washington, to the Desk Officer, by Internet electronic mail to bsjllnrc.gov; and NEOB-10202, (3150-0014),

office of Information and Regulatory Affairs, DC 20503.

Office of Management and Budget, Washington, Public Protection Notification

is not required to

The NRC may not conduct or sponsor, and a person a currently

unless it displays

respond to, a collection of information

valid OMB control number.

KAttachwent

X- 1 IN 97-04 February 24. 1997 Regulatory Analysis final rule. The

The NRC ha- prepared a regulatory analysis for this considered

analysis examines the costs and benefits of the alternatives

the NRC concluded that only

by the NRC. In the response to comments, were necessary, some minor changes to the draft regulatory analysis

corresponding to some minor procedural changes inin the final rule. The

available for inspection the NRC Public

regulatory analysis is Washington, DC 20555- Document Room, 2120 L Street, NW. (Lower level),

of the analysis may be obtained from Alan K.

0001. Single copies U.S. Nuclear

Roecklein, Office of Nuclear Regulatory Research,

(301) 415- Regulatory Ciiassion, Washington, DC 20555-0001, telephone

6223.

Regulatory Flexibility Certification

In accordance with the Regulatory Flexibility Act of 1980, (5 U.S.C. 605(b)), the Cominision certifies that this rule will not have a

number of small entities.

significant economic impact on a substantialwith emissions of

This final rule only impacts NRC licensees

material who would be required to

significant quantities of radioactive licensees from the

report the exceedance to the NRC. It will relieve

The level of air emissions from

unnecessary burden of dual regulation. below the NRC dose

NRC-licensed facilities has historically been well

the EPA standard.

limit and except for a few unusual cases, readily met

([Page 6512711

Backfit Analysis

The NRC has determined that the backfit rule, 10 CFR SO.109, does

does not apply to power reactor

not apply to this final rule because it is not required for this

licensees, and therefore, a backfit analysis

not involve any provisions which

final rule because these amendments do

would impose backfits as defined in 10 CFR 50.109(a)(1).

List of Subjects In 10 CFR Part 20

Byproduct material, Criminal and penalties, Licensed material, Nuclear

materials, Nuclear power plants 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 Energy under the authority of

Act of 1954, as amended, the Reorganization

the Atomic Energy the

Act of 1974, as amended, and 5 U.S.C. 553, the NRC is adopting

following amendments to 10 CFR Part 20.

PART 20--STAIDARDS FOR PROTECTION AGAINST RADIATION

read as follows:

1. The authority citation for Part 20 continues to

Authority: Secs. 53, 63, 65, 81, 103, 104, as161, 182, 186, 68

949, 9S3, 955, amended, sec. 1701, stat. 930, 933, 935, 936, 937, 2073, 2093, 2095, 2111, 2133,

106 Stat. 2951, 2952, 2953 (42 U.S.C.

202, 206, 98

2134, 2201, 2232, 2236, 2297f) secs. 201, as amended, 5841, 5842, 5846).

stat. 1242, as amended, 1244, 1246 (42 U.S.C.

added to read

2. In Sec. 20.1003, the definition of Constraint is

as follows:

Sec. 20.1003 Definitions.

specified

Constraint (dose constraint) means a value above which

licensee actions are required.

Attachment 1 IN 97-04 February 24. 1991 to read as follows: 3. In Sec. 20.1101, paragraph (d) is added

Sec. 20.1101 Radiation Protection Programs.

  • * * * *

of Sec. 20.1101 (b), and

(d) To implement the ALARA requirements 20.1301 of this part, a

notwithstanding the requirements in Sec. material to the environment, constraint on air emissions of radioactive

shall be established by

excluding Radon-222 and its daughters, to Sec. 50.34a, such that the

licensees other than those subject to receive the highest dose will

individual member of the public likely dose equivalent in excess

not be expected to receive a total effective

emissions. If a licensee

of 10 mrem (0.1 mSv) per year from these dose constraint, the licensee

subject to this requirement exceeds this

in Sec. 20.2203 and promptly

shall report the exceedance as provided ensure against recurrence.

take appropriate corrective action to

20.2203 the section heading is revised, a new paragraph

4. In Sec. and (b)(2) are revised

(a)(2)(vi) is added, and paragraphs (b)(1)(iv)

to read as follows:

levels, and

Sec. 20.2203 Reports of exposures, radiation exceeding the constraints or

concentrations of radioactive material

limits.

(a) * * *

(2) * * * established under

(vi) The ALARA constraints for air emissions

Sec. 20.1101(d); or

(b) * * *

(1) * * * to ensure against a

{iv) Corrective steps taken or planned conformance with

for achieving

recurrence, including the schedule generally applicable

applicable limits, ALARA constraints, license conditions.

environmental standards, and associated paragraph (a) of this section

(2) Each report filed pursuant to

overexposed \7\ individual: the

must include for each occupationally and date of birth. The report

name, Social Security account number, is stated in a separate and

must be prepared so that this information

detachable part of the report. __________________________________________________________________________

embryo-fetus

\7\ With respect to the limit for the those of the declared

should be

(Sec. 20.1208), the identifiers

pregnant woman.

day of December, 1996.

Dated at Rockville, Maryland, this 3rd

For the Nuclear Regulatory Comission.

John C. Boyle, Secretary of the Oondisidon. am]

(FR Doc. 96-31221 Filed 12-9-965 8:45 BILLING CODE 7590-01-P

- y

i- Attachment 2 IN 97-04 February 24, 1997 LIST OF RECENTLY ISSUED

NMSS INFORMATION NOTICES

I

nformation Date of

Notice No. Subject Issuance Issued to

97-03 Defacing of Labels to Comply 02/20197 All material licensees

with 10 CFR 20.1904(b) involved with disposal of

medical waste

96-72 Undetected Failures that May 12/24/96 All teletherapy licensees

Occur During Patient Treat- ments with Teletherapy

Devices

96-70 Year 2000 Effect on Computer 12/24196 All U.S. Nuclear Regulatory

System Software Commission licensees, certi- ficate holders, and regis- trants

96-66 Recent Misadministrations 12/13/96 All U.S. Nuclear Regulatory

Caused by Incorrect Cali- Commission Medical Use

brations of Strontium-90 Licensees authorized to use

Eye Applicators strontium-90 eye applicators

96-63 Potential Safety Issue 12/05/96 All U.S. Nuclear Regulatory

Regarding the Shipment Commission licensees

of Fissile Material authorized to possess special

nuclear material in unsealed

quantities greater than a

critical mass

96-57 Incident-Reporting Require- 10/30/96 All U.S. Nuclear Regulatory

ments Involving Intakes, Commission licensees

During a 24-Hour Period

that May Cause a Total

Effective Dose Equivalent

in Excess of 0.05 Sv (5 rem)

96-54 Vulnerability of Stainless 10117/96 All material licensees

Steel to Corrosion When

Sensitized

K>-y

Attachment 3 IN 97-04 February 24, 1997 LIST OF RECENTLY ISSUED

NRC INFORMATION NOTICES

Information Date of

Notice No. Subject Issuance Issued to

97-03 Defacing of Labels to 02/20/97 All material licensees

Comply with 10 CFR involved with disposal

20.1904(b) of medical waste

97-02 Cracks Found in Jet Pump 02/06/97 All holders of OLs

Riser Assembly Elbows at or CPs for boiling

Boiling Water Reactors water nuclear power

reactors models 3,

4, 5 and 6, except

those licenses that

have been amended to

possession-only

status

97-01 Improper Electrical Ground- 01/08/97 All holders of OLs

ing Results in Simultaneous or CPs for nuclear

Fires in the Control Room power reactors

and the Safe-Shutdown Equip- ment Room

96-72 Undetected Failure that 12/24/96 All teletherapy

May Occur During Patient licensees

Treatments with Teletherapy

Devices

Licensee Response to Indi- 12/27/96 All holders of OLs

96-71 cations of Tampering, Van- or CPs for nuclear

dalism, or Malicious Mis- power reactors

chief

OL = Operating License

CP = Construction Permit

IN 97-04 February 24, 1997 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

and Safeguards

Technical contacts: Cynthia Jones, NMSS John Kinneman, RI

(301) 415-7853 (610)337-5252 E-mail: cgj@nrc.gov E-mail: jkd@nrc.gov

John Potter, Ril Brenda Holt, R1iI

(404) 331-5571 (630) 829-9836 E-mail: jpp@nrc.gov E-mail: bjh@nrc.gov

Linda Howell, RIV

(817) 860-8213 E-mail: llhenrc.gov

Attachments:

1. Federal Register Notice on the Constraint Rule

2. List of Recently Issued NMSS Information Notices

3. List of Recently Issued NRC Information Notices

Coordinated with: C. Jones

P. SobeVB. Nelson,DWM

Id

nnfel IM11AIT1 rK1MF- fZ.0-nAQ.0S

OFC I IMOB IMOB I IMOB NRR l OGC I IMNS I

NAME SSherbini/ll CHaney JPiccone SWeiss FCameron DCool

DATE 1/22/97 1122/97 1/23/97 7 2/6/97 2/11/97 l

OFFICIAL RECORD COPY

IN 97-XX

January XX, 1997 Coordinated with: C. Jones

P. Sobel/B. Nelson,DWM

I IMNS OFC

I /97 j

DOCUMENT NAME: G:IN.SS 6n

OFC IMOB I x- I lMO Io E -z lI I

NAME SSherbini/ll CHaney IPiccone SWeiss FCameron ,__

_ _ool

DATE \ /z -197 It /rL/97 / T3/97 / /97 WJ Zi97 tL/l1 /97

)FFICIAL RECORD COPY

IN 97-XX

January XX, 1997 have been approved by EPA to show pliance with 40 CFR Part 61, Subpart I. Licensees

may also propose their own site- ific methods for showing compliance, subject to NRC

approval before use.

Donald A. Cool, Director

Division of Industrial and

Medical Nuclear Safety

Office of Nuclear Material Safety

and Safeguards

Technical Contacts:

Headquarters: Cynthia Jones

(301) 415-7853, cgjeJnrc.gov

Region I: John Kinneman

(610) 337-5252, jkdinrc.gov

Region II: John Potter

(404) 331-5571, jpp~nrc.gov

Region III: Brenda Holt

(630) 829-9836, bjhenrc.gov

Region IV: Linda Howell

(817) 860-8213, llhenrc.gov

Attachment:

Federal Register Notice on the Constraint Rule

Coordinated with: C. Jones

P. Sobel/B. Nelson,DWM

lIMN /0FC

O

DOCUMENT NAME: G:IN.SS

l OFC IMOB IMOB IMi OGC IMNS

NAME Shierini/ll CHaney piccone 6 914W FCameron DCool

DATE l lZ/97 d~F~IRRCORD COPY{

l l 7 /97 / 23/97 -It6 /97 7 /97 I /97

____ ____