ML19350A535

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Informs That Proposed Final Rule to Amend 10CFR20 May Be Subj to Legal Challenge.Inadequacies Exist in Analysis Supporting Conclusion That Environ Effects of Rule Would Be Insignificant.Attachment 2 of Value/Impact Statement Encl
ML19350A535
Person / Time
Issue date: 02/09/1981
From: Malsch M
NRC OFFICE OF THE GENERAL COUNSEL (OGC)
To: Ahearne J, Gilinsky V, Hendrie J
NRC COMMISSION (OCM)
Shared Package
ML19219A599 List:
References
REF-10CFR9.7 NUDOCS 8103160446
Download: ML19350A535 (13)


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UNITED STATES y $ s,((( gg NUCLEAR REGULATORY COMMISSION 2OW^A E

WASHINGTON, D. C. 20555 r

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%..%,r... f February C,

1981 MEMORANDUM FOR:

Chairman Ahearne Conmissioner Gilinsky Cc=missioner Hendrie Commissioner Bradford

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FROM:

Martin G. Malsch Deputy General Counsei SU3 JECT:.

PROPOSED FINAL EULE TO AMEND 10 CFR PART 20 REGARDING DISPCSAL OF TRITIUM AND CARBON 14 SECY-81-77 Staff has requested your approval te issue a final rule which wculd anend Part 20 limits on the disposal of hydrogen-3 (tritiu=) and carbon-14.

In our view, the rule may be subject to legal challenge because of inadequacies in the analysis supporting the conclusion that the environmental effects of this rule would be insignificant.

The amendments would have the following effects:

1.

NRC licensees would be permitted to dispose of as non-radio-active waste unlimited cuantities of liquid scintillation media and animal carcasses containing tritium and carbon-14 in concentrations of 0.05 microcu-ies or less; and i

2.

The quantities of these radioactive materials releasable into the sanitary sewer system every year would be 5 curies per year for tritium and 1 curie per year for carbon-14.

l l

These changes are in response to requests from bionedical licensees l

who use these isotopes.

Currently, contar*nated liquid scintilla-tion media and animal carcasses are buried in low-level-radioactive waste disporal sites even though the current re5ulations permit l

some unregulated disposal of these =ateria_s.

Regardin5 disposal l

into the sanitary sewer system, the cur: nt NRC limit is one curie per year per licensee for all radioactive materials disposed of in that manner.

l CONTACT:

Sheldon L. Trubatch, GC X-43224 E m 0SM E 1 8103160

The Commission 2

February 9, 1981 l

1 l

l l

Staff estimates that the proposed arendments would result in an increased annual release of 28 curies of tritiun and 6 curies of carbon-14.

The concommitant dose wculd be less than one millirem per year to an individual, and uould result in approximatelv one health effect (cancer death) frem the radioactive a erial released each vear.2e We did not have an opportunity to creviously review this conclusion because a collective dose estimate was not provided with the proposed rule.

The conclusion that the environmental impact is insignificant should be compared with the Commission's decision on the occupa-tional dose associated with replace ent of the Surrev steam c.enera-tor.

11 NRC 405 (1980).

There the Commission found that it could not determine whether an occupational exposure of 2070 person-rem is significant for the purposes of the national Environmental Policy Act, where the analysis simply compared the dose with background radiation dose, and ordered the preparation of an environmental impact statement.

By contrast, in this case, staff estimates that the public will receive a collective dose of 3,720 person-rem from just one year's release of Carbon-14, but has not even crecared an environ = ental imcact a=:raisal or necative declara-

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"creover, staff states that even if its calculations are in error by a couple of orders magnitude (up to 100 cancer deaths for each year's material), the collective doses and health effects resulting from the rule would be insignificant.

Under these circumstances, we believe that the lack of any accompanying environmental analysis leaves the rule open to legal challenge.

This potential for litigation should be con-si'dered in any final decision on i.. suing a final rule at this time.

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SECY (2)

OPE (2)

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l This total dose commitment may be underestimated because the calculation does not appear to consider the environ-mental build-up of Carbon-14 which has a half-life of over 5,000 years.

Meteover, there is no consideration of pos-sible increases in the use and disposal of radioactive I

medical waste.

1 2/

The relation of this collective dose to the total collec-l tive dose from naturally occurring Carbon-14 is irrelevant l

to the issue of whether significant consequences to humans l

will result from the dose allowed by the rule.

i Value/ Impact Statement i

1 i

l Disposal of Liquid Scintillation Media and Animal Carcasses Containing Tracer Levels of H-3 or C-14 Without Regard to Their Radioactivity:

Estimates of Maximum Potential Radiation Dose to an Individual and Total Collective Dose 3

ENCLOSURE 2

The radia', ion dose comitment to an individual due to disposal of liquid scintillation counting wastes and animal carcasses containing H-3 and C-14 is calculated in this report.

Both inhalation and ingestion pathways are considered in the calculations.

Since H-3 and C-14 are low energy beta etaitters, the external exposure from these two sources will not be considered.

The dose commitment is calculated according to the following basic equation.

D = C x U x DCF Where D is the dose ccmmitment to a given organ of an individual, in crea/yr; C is the concentration of a nuclide in the media, in pCi/ liter; U is the usage factor unit in liter /yr; and DCF is the dose conversion factor in units of mrem or crem per C_ i, '

3 pCi yr m

(I)

Inhalation Mode Dose commitment to an individual is calculated based on the assumption that the in/,1vidual inhaled contaminated effluents produced by com-bustion of animal carcasses and liquid scintillation counting wastes containing H-3 md C-14.

The calculation is also based on the following assumptions:

(1) H-3 and C-14 enter the human body by inhalation in the form of HTO and CO respectively.

2 (2) Source terms:

total activity

  • to be burned over a year for H-3 and C-14 is 0.275 Ci and 0.075 Ci respectively.
  • Represents the annual activities in the liquid scintillation wastes and animal carcasses generated in large research and medical institutions in this country as determined in an NRC in-nouse survey.

i 2

(3) The nearest resident is located about 10-40 meters frca the incinerator. The air concentration once exiting the incinerator will be reduced by an atmospheric dilution factor of 10-3 sec/m when it reaches the nearest resident.

3 (4) The incinerator is operated 2000 hours0.0231 days <br />0.556 hours <br />0.00331 weeks <br />7.61e-4 months <br /> per year.

Dose From Inhalation D = C x U x DCF Where 0 = Dose commitment due to inhalation by an individual remaining at a distance of 40 neters downwind from the incinerator for the entire year; C = Concentration of radioactive effluents at 10 40 meters frca the incinerator, and is calculated as follows:

C = Activity (Ci) x X/Q sec x hrs incinerator operation time (nrs) 3600 sec 3

m For H-3:

10-3

= 0.275 Ci x

sec x

hrs 2000 hrs 3600 sec 3

I

= 3.8 x 10~II g

3.8 x 10 oCi

=

3 3

m m

3 For C-14:

10-3 sec x

hrs 0.075 Ci x

=

2000 nrs 3600 sec m

3 I

3 1.0 x 10-II Ci/m 1.04 x 10 pCi/m

=

=

1 Breathing rate, II:

3 3 3 U = 8000 m /yr x yr x

2000 hr

= 1.83 x 10 m /yr 8760 hr yr DCF: Dose conversion factors for inhalation dose were cbtained from Regulatcry Guide 1.10g.

CCF for H-3 (total body as critical organ) is 1.58 x 10-7 mrem pC1 DCF for C-14 (bone as critical organ) is 2.3 x 10-6 mrem pct.

Dose due to inhalation of H-3 l

1 3

3 1.5a x 10-7 3.a x 10 oCi x 1.s3 x 10 m

x O _3 mrem

=

g yr pC1 l

3 m

0.01 mrem /yr (total body)

=

Ocse due to inhalation of C-14:

3 3 x 2.3 x 10-6 DC-14 = 1.04 x 10 oCi x 1.83 x 10 g

mrem 7"

PCl 3

l m

0.04 =ren/yr (bone)

=

i (II)

Incestien Mode l

rne estimated dose due to dietary and drinking water intake of H-3 and C-14 from incineration of biomedical wastes is also calculated

[

under assumptions 2 and 3 listed for the inhalation mode.

In addition, it is assumec the food and drinking water are in equilibrium with the

4 specific activity of H-3 in the atmosphere, and the specific activity of C-14 in human tissue is equal to the average steady-state value in the atmosphere.

The methodology of the calculation is presented fully in ORML-4992, "A Methodology for Calculating Radiation Dose frem Radioactivity Release to the Environment."

A.

Dose from ingestion:

0 = C x DCF Where 0 = Dose in mrem /yr due to dietary and drinking water intake; C = Annual average concentration of radioactivity at 10-40 meters from the incinerator resulting frem the incineration of 0.275 Ci H-3 and 0.075 Ci of C-14 annually.

For H-3:

10-3 C=

0.275 Ci x

sec x

hrs 3600 sec yr 3

m 10~3 0.275 Ci x

sac x

hrs

=

8760 nr/yr 600 sec 3

m 8.7 x 10-12 C1/m 3

=

For C-14:

C=

0.075 Ci x 10-3 sec x

hrs 8760 hr/yr 3600 sec 3

m 3

' 2.4 x 10~I2 Ci/m

=

m-

I 5

3 DCF = Dose conversion factor in mrem /yr/Ci/m, annual dose rate per unit air concentration of H-3 or C-14 radioactivity at the point of interest (data taken from ORNL-4992):

For H-3, with total bcdy as critical organ:

9 3

DCF = 3.68 x 10 mrem /yr/Ci/m For C-14, with bone marrow as critical organ:

12 3

DCF = 2.22 x 10 mrem /yr/C1/m Dose due to ingestion of H-3:

9 3

3 0 = 3.68 x 10 mrem /yr/C1/m x 3.7 x 10-12 C1/m

= 0.03 mrem /yr to total body Dose due to ingestion of C-14:

12 3

3 D = 2.22 x 10 mrem /yr/Ci/m x 2.4 x 10-12 Cf/m

= 5.33 arem/yr to bone marrow 9

6 B.

Dose due to drinking water contaminated from sewer releases of H-3 and C-14.

The dose is calculated to an individual who subsists on the potable water supply from the sewage treatment plant.

It is further assumed that a very large user of tritium and carbon-14, located in a metropolitan area and upstream from the treatment plant, discharged 5 curies of H-3 and 1 curie of C-14 into the sewer in a single day.

The doses to the critical organ of an individual were calculated by using dose conversion factors given in NRC Regulatory Guide 1.109.

Dose from Incestion D = C x U x DCF 0 = Dose in mrem /yr due to ingestion of contaminated water C = Potable water concentration of H-3 and C-14.

It is assumed that the discharged 5 Ci of H-3 and 1 Ci of C-14 was diluted by a 6

volume of 5 x 10 gallons water at releasing point of the 6

water treatment plant. 5 x 10 gallons of water repre:aias the total water that is being handled each day by a large city's water treatment facility.

7 For H-3:

12 2

C=

5 Cf/yr x 10 oci/Cf

= 7.2 x 10 cCi 5 x 106 gal / day x 3.7851/ gal x 365 days /yr liter For C-14:

I 2

C=

1 Ci/yr x 10 ' pCf/Ci 1.4 x 10 oCi

=

5 x 106 gal / day x 3.7851/ gal x 365 days /yr liter U = Water consumption rate per year = 730 liter /yr max.

3 DCF = Dose conversion factors for ingestion For H-3:

1.05 x 10-7 mrem (Total body as critical organ) pCi For C-14:

2.8 x 10-6 mrem (Bone as critical organ) pCi Dose due to ingestion of H-3:

2 D = 7.2 x 10 pCi x 730 liter /yr x 1.05 x 10-7 mrem liter pCi l

l

= 5.52 x 10-2 mrem /yr l

= 0.06 mrem /yr (Total body) t l

l l

(

8 Dose due to ingestion of C-14:

D = 1.4 x 10 pCi x

730 liter x 2.8 x 10-6 2

mrem liter yr PCT ~

l

= 0.3 mrem /yr (Bone)

CoIYective Dose Assessment For the scintillation media and animal carcass snendment:

The collective doses resulting from the rule change may be readily calculated by assuming that all the hydrogen-3 and carbon-14 used in scintillation media and animal carcasses in a year is released to the environment through incineration.

The population of the United States is employed in calculating the collective l

~

dose. Employing the calculational approach used in the Final Generic Environmental Statement on the Use of Recycle Plutonium in Mixed Oxide Fuel in Light Water Cooled Reactors (GESMO), it is estimated that 100 curies of hydrogen-3 delivers 1 person-rem to the U.S. population. Since 28 curies of hydrogen-3 could be i

released per year as a result of the rule, this would yield 0.28 person-rem in total. The National Acadesy of Sciences BEIR-III report estimates 1 health effect per 10,000 person-rem. Hence we estimate 0.00003 health effects per year from the release of hydrogen-3.

l l

l l

l 9

For carbon-14, the model described in the report entitled "A Diffusion-Type Model of the Global Carbon Cycle for the Estimation of Dose to the World population from Releases of Carbon-14 to the Atmosphere," ORNL-5267, was used.

This report indicates a collective dose commitment of 620 person-rem per curie of carbon-14, or 3,720 person-rem in total for the 6 curies released each year via the rule. Again, using the 1 health effect per 10,000 person-rem frcm the BEIR-III report, we estimate a total of 0.37 health effects to the world popul ation. Hence, employing assumptions which oterestimate the likely exposures, we conclude the rule change would result in less than one health effect per year.

For the sewer release amendment:

To calculate the collective dose from this change, we assume drinking water is the primary pathway and that all the radioactivity released will be consumed by the U.S. population.

Assuming water contains about 300 pCi/I of hydrogen-3 from natural sources, and that the maximum personal consumption of water is 7301/yr, we have:

6 300 pCi/I x 730 t/ person /yr x 1 x 10~7 mrem /pCi x 225 x 10 persons in U.S.

5000 person-rem /yr to US population from naturally occurring hydrogen-3

=

in drinking water.

Multiplying the collective dose from naturally occurring hydrogen-3 in drinking water by the ratio of the quantity released by the rule and the quantity naturally in the environment yields an approximation of the collective dose due to the rule change. If we assume 25 facilities t11 release 5 curies, we have 125 Ci total or mwee

10 125 C1 (released) x 5000 person-rem = 0.02 person-rem 6

28x 10 C1 (environmental inventory)

At 10,000 person-rem / health effect, this results in very much less than 1 health effect per year.

Carbon-14 is known to contribute about 1". of the natural background dose to the U.S. population.

If the average background dose per person is 0.1 rem, 6

5 the natural background dose is about 22.5 x 10 person-rem with 2.25 x 10 person-rem due to carbon-14.

We again determine the fraction of this collective dose, received primarily through ingestion of naturally occurring carbon-14, that would result from the rul e.

Thus, if 25 facilities all released 1 curie of carbon-14, a total of 25 5

curies would be released. Since we estimate that 2.25 x 10 person-rem is received by the U.S. population from the 280 million curies in the environment, we can approximate that an additional 25 curies would yield an additional 5

25 C1 (released) x 2.25 x 10 person-rem = 0.02 person-rem 6

280 x 10 C1 (environmental inventory)

Again, at 10,000 person-rem / health effect, this would yield very much less than

_ 1 health effect per year.

(

Even if our results were in error by a couple orders of magnitude, the conclusion i

would remain the same:

the collect *ve doses and health effects resulting l

from the rule are estimated to be so small that they are negligible.

4 i

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February 9,1981 j

SECY-81-100 j

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RULEMAKING ISSUE (Affirmation)

For:

The Commissioners From:

William J. Dirck:

Executive Director for Operations

Subject:

WITHDRAWAL 0F PROPOSED RULEPAKING ON THE BURDEN OF PROOF IN ENF0P. CEMENT PROCEEDINGS Purcose:

To obtain Commission approval of a Federal Register notice announcing the withdrawal of a proposed rule-making on the burden of proof in enforcement proceedings.

Ca teaory:

This paper covers a routine matter.

Discussion:

The Comission published in the Federal Register on July 21,1977 a proposed rule change to 10 CFR s 2.732 that would generally provide that the proponent of an order in an enforcecent proceeding would have the burden of proof.

In SECY-80-212, dated April 25, 1980, the Staff discussed the public comments received on the pro-posed rule and recomrended that the Comission approve publication of the final rule.

(Enclosure A). The Commission disapproved the Staff's recommendation.

(Enclosure B)

The attached Federal Register notice fomally withdraws the notice of propcsed rulemaking.

Contact:

Bruce A. Berson, OELD 492-7678 w

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,\\}3lyf 5,#gkokg s,

ce DU C&"I

The Commissioners ;

Recommendation:

That the Commission approve the withdrcwal of proposed rulemaking.

/

William. Dircks l

Executive Director for Operations I

Enclosures:

A.

SECY-80-212, April 25, 1980 B.

Memorandum, S. Chilk to W. J. Dircks, June 20, 1980 C.

Proposed Federal Register notice Comissioners' coments or consent should be provided directly to the Office of the Secretary by c.o.b. Wednesday, February'25, 1981.

Comission Staff Office coments, if any, should be submitted to the Commissioners NLT February 18, 1981, with an information copy to the Office of the Secretary.

If the paper is of such a nature tht it *equires additional time for analytical review and coment, the Comissioners and the Secretariat should be apprised of when coments l

j may be expected.

This paper is tentatively scheduled for affirmation at an Open Meeting during the i

Week of March 9, 1981.

Please refer to the appropriate Weekly ramission Schedule, when published, for a specific date and time.

I DISTRIT.. TION Comissioners Comission Staff Offices Exec Dir for Operations ACRS ASLBP ASLAP Secretariat L

' ' ^

~

[L.L) Ms. /se en u%st3tts f,()py NUCLEAR REGULATORY COMMISSION April 25,1980

.i WASHINGTON, D. c. 2o655 SECY-80-212 CONSENT CALENDAR ITEM For:

The C musioners Frem:

Howard K. Shapar 8

Eracutive Legal Director k

Thru:

William J. Dircks v

Acting Executive Director for Operations

Subject:

PUBLICATION OF FINAL RULE, A'1E!!Dt4ENT TO 10 CFR 2.732 ON BURDEN OF PROOF

Purpose:

To obtain Comission consent to publish an amended 10 CFR 2.732 as a final rule.

Category:

This paper covers a routine matter.

Discussion:

On July 21, 1977 the Commission published in the Federal Register a proposed rule change to 10 CFR 2.732 that would generally provide that the proponent of an order in an enforcement proceeding would have the burden of proof (Enclosure B). The burden of proof was defined as including both the initial burden of going forward with evidence (producing enough evidence to make a case) and the ultimate burden of persuasion (the need to establish the validity of a contention, or overcome opposing evidence). The presiding officer in a pro-ceeding would be authorized to assign the burden of proof to a party other than the proponent.

.A primary purpose of the proposed rule change, as explained in the Statement of Considerations accom-l panying the proposal (Enclosure B), was to give I

expression to a basic concept of fairness that after a licensing and review process had been completed and a construction permit issued, it was generally unnecessary for effective enforcement and unreasonable to require the pemittee continually to prove the absence of pemit violations.

Contact:

Robert L. Fonner 492-8632 7'

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%d a alf%

I C

ENCLOSURE A g

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V The Commissioners.

In SECY 76-528, and 3ECY-77-226 (Enclosures C and D),

the st ff also noted additional policy reasons for the propotsd change.

First, as a practical matter the staff must go "all out" to prove its case in an enforcement action regardless of who formally bears the burden of persuasion.

Second, a reviewing court can uphold the agency on evenly d)i*de' evidence so long as the agency's finding is based upon substantial evidence, but is likely to reverse if the agency erred in procedurally assigning the burden of proof to the wrong party.

Thus, assigning the rurden to the proponent of an order (in this case the agency) is a conservative approach.

Thirteen letters of comment ware received on the pro-posed rule. Ten of the commenters were in favor of the l

proposed rule change without reservation.

One commenter favored the proposal but generally without the grant of discretionary authority to the presiding officer to shift the burden of proof that the proposed rule would allow. This commenter, hosever, also agreed that under current law the Commission could set the presiding officer assign the burden of persuasion in his discretion, but was firmly convinced that allowing a discretionary shifting of the burden of going forward with the evidence would be contrary to Section 7(c) of the Administrative Procedure Act (APA) (5 U.S.C. 556(d))

in absence of a statute authorizing such a shift.

(It should be noted that in the Statement of Considerations accompanying the proposed rule, the Commission stated that it believed that the Atomic Energy Act did not provide any statutory) exception to the generil ru i

stated in Section 7(c of the APA.) The bas's of this Fund v.

commenter's position is Eniironmental Defer tr'eTTil EPA, 548 F.2d '98 (D.C. D r.1977), cert deni U!3I. 925 (191/ i which held that under Section 7(c) the proponent of an order has the burden of going forward with the evidence.

One commenter recommended " strict" adherence to the inteipretation of Section 7(c) of the APA set forth in Environmental Defense Fund v. EPA.

He supported allo-cation of the burden of going forward to the proponent The " general rule" in Section 7(c) of the APA (5 U.S. 556(d)) is, J/

"Except as otherwise provided by statute, the proponent of a rule or order has the burden of proof. * * * "

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The Commissioners of an order, but not the ultimate burden of persuasion, which he believed should remain with the licensee.

He also opposed any grant of discretion to the presiding officer.

These last two comenters both made the point strongly that under Section 7(c) of the APA, as uterpreted by the court in Envirornnental Defense Fund v. EPA, the burden of going forward with the evidence is always on the proponent of an order, and therefore no discretion should be allowed to the presiding officer to shift that burden.

In our analysis that is a correct statement of the present law, and the revised rule for final approval has been changed to accord with it.

(SeeEnclosureA).

An option remains of not changing 10 CFR 2.732. This option would, however, leave in place a rule that on its face appears contrary to present law; that is, it appears to permit a presiding officer to shift the burden of going forward with evidence to someone other than the proponent of an order.

Further, it leaves open the possibility of procedural error occurring in an enforce-ment proceeding if the burden of going forward with evidence is placed upon the licensee, as noted earlier in this paper.

Such a course of inaction would also leave as agency law the holding on burden of proof of Consumers Power Company (Midland Plant, Units 1 and 2)

ALAB-283, 2 NRC 11 (1975), ALAB-315, 3 NRC 101 (1976),

which appears to be at odds with Environmental Defense Fund v. EPA.

It was the Midland case that raised Commis-sioner concern about the question of burden of proof (See SECY-76-528), and abandonment of the rulemaking proceed-ing would indicate Caission acquiescence in the Midland l

holding.

It should be noted that the changes of substance in 10 CFR 2.732 relate only to proceedings taken under Subpart B of Part 2, dealing with enforcement-type actions.

Special allocations of burden of proof devel-oped by the licensing and appeal boards in CP and OL licensing proceedings under Subparts D, E, F, and G, of Part 2 are not affected by this amerdment of 10 CFR 2.732.

(See _e.S., Cleveland Electric Illuminatine Co.

(Perry Nuclear Power Plant, Units 1 and 2), ALAB 443, 6 NRC741,752-754(1977), allocating)the burden of proof on motions for summary dispositiont.

i

t The Comissioners Recommendation:

That the Comission approve publication of the final effective rule.

Coordination:

The Office of Inspection and Enforcement concurs.

Sunshine Act:

Recommended for an open meeting, if discussed.

$Y lN Howard K. Shapar '

Executive Legal Director

Enclosures:

A - Notice of Final Rule B - Notice of Proposed Rule C - SECY-76-528 (without its enclosures)

D - SECY-77-226 (without its eaclosures)

Comissioners' comments or consent should be provided directly to the Office of the Secretary by c.o.b. Monday, May 12, 1980.

Comission Staff Office coments, if any, should be submitted to the Comissioners NLT May 5,1980, with an information copy to the Office of the Secretary.

If the paper is of such a nature that it requires additional time for analytical review and coment, the Commissioners and the Secretariat should be apprised of when coments may be expected.

This paper is tentatively scheduled for affirmation at an Open Meeting during the Week of May 19, 1980.

Please refer to the appropriate Weekly Comission Schedule, when published, for a specific date and time.

DISTRIBUTION:

Comissioners Comission Staff Offices Executive Director for Operations ACRS Secretariat

[

s:. Dirck.1

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UMTED STATES bCt. EAR REGULATORY COMMISSI r -

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MEMORANDUM 70R:' '

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Samuel J..Chilk, Se' reta gp FROM:.

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. FSJECT:~.-

.SECY-80-212 - PUBLICATIO 6 01 FINAL RULE, AMENDMENT TO i

10 CFR 2.732 ON BURDEN,0F PROOF. (CONSENT.CALENDARITEM)

This is to advise you that the Comission (with four C'ommissioners concurring) has disapproved the staff's recomendation in the subject paper.

Comissioner Kennedy approved the staff's recomendation, and noted:

"The action taken by the majority in disapproving the proposed rule l

change set forth in the subject paper reflects a continuing and unfortunate insensitivity on the part of this Conmission to the rights of.tho.se who have been granted construction pennits or operating ' licenses.' The applicant in either case most certainly bears -the responsibility for establishing that all applicable requirements have been satisfied prior to issuance of a construction permit or operating license.

But once this Comission decides that the applicant has carried its burden in this respect, it is simply unconscionabler if not illegal, to subject the licensee to the intenninable tr,k of' responding to staff-initiated enforcement actions by establishing the absence of permit violations. ~This is a burden which properly belongs to the staff, with its extensive data-gathering capability, not the licensee.

Indeed, it is precisely this sort of approach to enforcement which diverts the time and resources of licensees from those tasks most central to maintenance of a high level of safety and instead leads to a result precisely the opposite of that intended."

cc:

Chairman Ahearne Comissioner Gilinsky Conrnissioner Kennedy Comissioner Hendrie Comissioner Bradford Comission Staff Offices Chairman, ASLAP Executive Legal Director gn n g gC?

h@LMN L

CONTACT I

SJSParry (SECf)

O 4-1410 f

hh ENCLOSURE B 1

(.E

NUCLEAR REGU'.ATORY COMMISSION

[10CFRPart2]

Burden of Proof in Enforcement Proceedings AGCNCY:

U.S. Nuclear Regulatory Commission.

ACTION:

Withdrawal of Proposed Rulemaking.

SUMMARY

The Nuclear Regulatory Commission is withdrawing a notice of proposed rulemaking that would have provided that the proponent of an order in Comission enforcement proceedings has the burden of proof, including the burden of going forward with the evidence and the ultimate burden of per-suasion.

i EFFECTIVE DATE:

(The date of publication in the Federal Register.)

FOR FURTHER INFORMATION CONTACT:

Bruce A. Brrson, Office of the Executive Legal Director, U.S. Nucloar Regulatory Comission, Washington, D.C. 20555, Telephone: (301)492-7678.

i SUPPLEMENTARY INFORMATION: On July 21, 1977, the Nuclear Regulatory Commis-l sion (Comission) published in the ideral Register (42 FR 37406) a proposed amendment to its regulations,10 CFR Part 2

" Rules of Practice for Domestic Licensing Proceedings," regarding the burden of proof in Commission adjudica-tions.

Under the proposed amendment to 10 CFR 5 2.732 the proponent of an l

ENCLOSURE C

.,' order to amend, suspend, or revoke a license or to impose a civil penalty in an enforcement proceeding against a licensee would have both the burden of going fomard with evidence (producing enough evidence to make a case) and the ultimate burden of persuasion (the need to establish the validity of a contention, or overcome opposing evidence), unless otherwise ordered by the presiding officer in a given case.M Thirteen letters of comment were receivea on the preposed rule.

Ten commenters favored the proposed rule change without reservation, one commenter generally favored the proposed rule, one commenter ob.iected to shifting the ultimate burden of persuasion from tne licensee to the proponent of an order and one commenter addressed a matter beyond the scope of the proposed rule.

After careful co.. sideration of the proposed rule change and the letters of comment, the Commission has decided that the holding of the Appeal Board in the Consumers Power Company case should not be modified by Commission rule.

Section 7(c) of the Administrative Procedure Act (APA), 5 U.S.C. 6 556(d),

and relevant judicial interpretations of the APA require that, except as othemise provided by statute, the proponent of an order has the borden of going fomard with evidence.

See Environmental Defense Fund v. EPA, 548 F.2d 998 (D.C. Cir.1977). However, the proposed rule would have gone beyond if The proposed rule would have had the effect of reversing the decision of the Commission's Atomic Safety and Licensing Appeal Board in Consumers Power Company (Midland Plant, Unit Nos.1 and 2), ALAB-283, 2 NRC 11 (1975), ALAB-315, 3 NRC 101 (1976). That decision held that the holder of a construction pennit has the ultimate burden of per-suasion in a Commission enforcement proceeding seeking revocation, suspension or modification of the pennit.

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. the requirements of the APA and generally required the proponent of an order in enforcement proceedings (usually the NRC staff) to also carry the ultimate burden of persuasion.

Having detemined that the proposed rule change to 10 CFR 9 2.732 is unwarranted, the Commission hereby withdraws the July 21, 1977 notice of proposed rulemaking on the burden of proof in enforcement proceedings and terminates this proceeding.

FOR THE NUCLEAR REGULATORY COMMISSION Samuel J. Ct. ilk Secretary of the Commission Dated at Washington, D.C.

this day of

, 1981.

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