ML20033D929
| ML20033D929 | |
| Person / Time | |
|---|---|
| Issue date: | 06/10/1987 |
| From: | Spangler M Office of Nuclear Reactor Regulation |
| To: | Murley T Office of Nuclear Reactor Regulation |
| Shared Package | |
| ML20033D930 | List: |
| References | |
| NUDOCS 8707100247 | |
| Download: ML20033D929 (35) | |
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g UNITED STATES NUCLEAR REGULATORY COMMISSION 1
wAsMiwoToN, D. C. 30856 I
June 10,1987
^
l-Thomas Murle. Director MEMORANDUM FOR:
' Office of. Nuflear Reactor Regulation i
FROM:
Miller Spangler, Special Assistant i
for Policy Development Office of Nuclear Reactor Regulation q
SUBJECT:
PROPOSED ISSUE FOR POLICY DEVELOPMENT REGARDING AN i'
" INTEGRATED DE MINIMIS RISK POLICY"
- In the staff meeting on May 19 you invited staff suggestions of candidate issues for policy development.- You will note in Figure 8 (p'. 314)- of the -
enclosed paper I prepared for Harold-Denton on "The Maturing of the U.S.
Nuclear Industry" that an' integrated de minimis risk policy is suggested as one of the government initiatives for improved regulation of risk policy issues.
- I:have explored a comprehensive set of policy issues on the subject' of de
- minimis risk in three interrelated papers. The first of these has been J
reproduced.from galley sheets and will soon be published; the latter two have recently been published.
(1)
"A Sumary Perspective on NRC's Implicit and Explicit Use of
'De Minimis. Risk Concepts in Regulating for Radiological Pro-taction in the Nuclear-Fuel Cycle," Chapter 12 in De Minimis Risk.Ed.by'ChrisWhipple-(NewYork: Plenum Press, 1987).
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(2), " Policy Issues Related To Worst Case Risk Analyses and the Establishment of Acce) table Standards of De Minimis Risk,"
j in Uncertainty in Rist Assessment. Risk Management, and Decision Making, Ed. by V. T. Covello, L. B. Lave, A. Moghiss' and V. R. R. Uppuluri (New York: Plenum Press, 1987).
(3)
"The Need for De Minimis Risk Standards in Regulatory Decision Making: An Individual or a Societal Risk Concept?" in Environ-mental Health Risks: Assessment and Management Ed. by R. Stephen McColl (Waterloo, Ontario: University of Waterloo Press,1987).
S 5y-h 7/000 h 1
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, -Thomas Murley -
The first paper on_the. nuclear fuel.cy'cle was basically a factual review of relevant NRC documents and papers dealing with regulatory policies.and concepts related to de minimis risk issues'on the following subjects:
Al. ARA (including-the proposed-10 CFR Part 20 revision); regulatory exemption levels; facility decommissioning; uranium mines and mills; nuclear waste _ management;
- safetygoalsand'asafety-costtrade-offcriterion;andsevereaccident policy.
The second paper examined the policy issues related to the CEQ's procedural requirements fo' dealing with worst case analyses and also explored four-r proceduralapproachesinarrivingatanacceptable(i.e., justifiable) standard of de minimis risk: (1) the exclusion of very low probability
. accident scenarios falling within the " noise level" of the range of uncertain'ty surrouncing the estimates of the overall severe accident risk of the more dominant accioer.t scenarios (2) the risk perspective provided by a
, comparison of nuclear health risks with the health risks of alternative-energy
-sources in common use that society regards as acceptable, if not negligible, (3) the perspective provided should the expected cost of countermeasures (health care or changes in lifestyle) be sufficiently small in compensating for the incremental health risk of the technological.or =egulatory options in questions, and-(4) the perspective provided by comparing the risk of such options (especially a proposed de minimis standard) with the risk levels of-activities that indivicuels engage in or accept without much, if any notable, concern in their routine lives or decisions.
The third paper is divided into two basic themes. The first of these explores the several needs or societal purposes that would be served by the establ.ish '
ment of an-acceptable standard of ds minimis risk: (1) to achieve a more '
efficient allocation'of societal resources in analyzing.or reducing those risks that are deservedly significant, (2) to improve the-treatment of equity issues between different parties of interest in regulatory actions, (3) to-achieve greater unifomity of risk management practices and policies among various regulatory agencies.* and (4) to aid legislators and courts in reaching conclusions regarding certain-issues of-individual and societal risk. The second thene of the paper focuses on the pros and cons of developing a de minimis risk policy from the standpoint of insignificant individual risk or an insignificant aggregation of societal risks. As-the-nuclear fuel-cycle paper illustrated. this latter question (though not explicitly addressed) was basically at the seat of the different approaches in the opposing conclusions reached by the NRC appeal boards and the Commission (see p.:21).
It is not clear, however, that such views on approaches to the question of an individual vs societal standard of de minimis risk were based ontany reasonably thorougnlackground study of the treatment of de minimis risk issues by the courts, the CEQ regulatory guidance, the surrounding body of literature by thought leaders of the scientific comunity, or any structured analysis of the pros and cons of these regulatory choices and the consistency question cutting across different policy issues of various aspects of the The need for greateFuniformity also applies to an integrated policy in NRC that will serve the variety of regulatory issues being dealt with by the various Offices of NRC.
,['[ ' ' Thomas Murley. '
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. nuclear fuel cycle. While my papers are scarcely definitive in this regard, Ithey at least would' provide a-useful starting point for a reexamination by-the Agency as to what an integrated de minimis risk' policy ought to accomplish and what it ought to be. ' A mixed strategy is not, of course, ruled out,. but-
~ it ought to-be carefully reasoned and justified.
A fifth purpose of establishing an integrated policy on de minimis risk (largely neglected in my 3 papers) is to provide a more accurate public perception of the personal significance or insignificance of different levels 4
-of. radiation risks. LThis purpose was identified and briefly discussed in the enclosed paper by Harold Denton (see p. 309) on "The.Causes and Consequences of
.the Chernobyl Nuclear Accident and Implications for the Regulation of U.S.
Nuclear Power Plants"..The high degree of controversiality over the aggregate estimates of-de>1ayed cancer fatalities in European nations as well as-the USSR provides a ready-made audience and regulatory opportunity for a-background-study paper that addresses the question of what is known and not known about radiation health risks and would put into clear perspective that a:
major fraction of the total Chernobyl fatality estimates (be they large or at the lower end of the spectrum) would be regarded as individually de minimis for key geographical zones of radionuclide exposure or deposition. Companion
" anxiety" benchmarks of exposure at, for example, a "beyond demonstrable 1
effect" (to use Weinberg's tem) of, say, 50 rems (total whole body dose).plus-a natural: background l radiation exposure rate of 100 arems/yr would provide O
additionalusefulinsighttothepublic(includinglegislatorsandjudges)by L
which to gauge the significance to the affected individuals-of tha Chernobyl i;
~ health consequences, I do hope the above suggestion of the need for an integrated policy development l
for de minimis, risk will: be given careful attention.
Attlud.&
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4 Miller B. Spangler 1
Special Assistant for Policy Development 1
Office of Reactor Regulation l
Enclosures:
As stated cc:
J. Funches
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H c-NRR SEMINAR Pig g
-"TOWARD AN lhTEGRATED DE MINIMIS RISK POLICY FOR THE NRC" MILLER B. SPANGLEli OCTOBER.13,1987 i
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,a g-w POLICY ISSUES REl.ATED TO DE MINIMIS RISK CONCEPTS F
' 8 WHY-IS IT NEEDED?
3 MiAT PURPOSES WOULD IT SERVE AS A EGULATORY T00L7 WiAT SAFETY A2 E0dNOMIC BEEFITS WOULD IT PROVIDE?
8 MiAT ARE TE ADVANTAGES OF AN INTEGRATED DE MINih!S L
RISK POLICY FOR TE NRC?
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WHO IS INTERESTED IN DE'MINIMIS RISK 7
.1, NATIONAL AND INTERNATIONAL AGENCIES INVOLVED IN' RADIOLOGICAL PROTECTION ISSUES 1
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(U.S.).NAT10NAL COUNCIL ON RADIOLOGICAL PROTECTION a MEASUREMENT (U.K.) NATIONAL RADIOLOGICAL PROTECTION BOARD INTERNATIONAL-COMMISSION ON RADIOLOGICAL PROTECTION INTERNATIONAL ATOMIC ENERGY AGENCY II. U.S. FEDERAL REGULATORY AGENCIES
'O FDA
- NRC
- OTHERS
!!I. OTHER AGENCIES AND SCIENTIFIC ORGANIZATIONS NATIONAL SCIENCE-FOUNDATION 0FFICE OF SCIENCE AND TECHNOLOGY POLICY NATIONAL BUREAU OF STANDARDS t
ELECTRIC POWER RESEARCH INSTITUTE SOCIETY FOR RISK ANALYSIS i
H$ALTHPHYSICSSOCIETY BROOKHAVEN NATIONAL LABORATORY L
4 0AK RIDGE NATIONAL LABORATORY IV U.S. COURTS (DE MINIMIS NON CURAT LEX - THE LAW DOESN'T DEAL WITH TRIFLES)
.J.:
NATIONAL GOAL MPROVING THE U S. OUTLOOM FOR PROGRESS IN THE MATURANON OF NUCLE AR RE ACTOR SAFETY TECHNOLOGY AND THE RESUMPTION OF INDUSTRY GROWTM RAfl0NAL12 ATION OF INDUSTRY b GOV 7 ROLES I
( INDUSTRY INITIATIVES )
( JOINT EFFORTS )
( GOVE RNMENT IMTIATIVES )
LEGISLATIVE REFORM NUCLEAR POWER PLANT DESIGN IMPLEMENTING THE LEGAL
=
FOR IMPROVED SAFETY 6 COST REQUIRgMENTS OF THE LICENSING PROCESS ADMINISTRATIVE REFORM b CHANGES IN GUIDELINES b IMPROVED CONSTRUCTION PE RFORM ANCE SAFETY PESEARCH STANDARD REVIEW PLANS IMPROVED RISK MANAGEMENT COMPONENT b SYSTEM CHANGES IN RULES OF OPERATING REACTORS RELIABILITY DATA FROM b REGULATIONS OPERAtlNG REACTOR EXPERIENCE
= ACCIDENT PREVENTION i
l OTHER RULEMAKING.
'i INCLUDING STANDARD
- ACCIDENT MANAGEMENT SOURCE TERM REvill0N DESIGN CERTIFICATION
CONSEQUENCE MITIGATION l REQutREMENTS FOR PROBASILlSTIC RISK COST EFFECTIVE SAFETY IMPROVED COST ASSESSMENT METHODOLOGY IMPROVEMENTS THROUGH mama
PERFORMANCE OF GENERfC LETTERS AND OPERATING REACTORS SULLETINS b ORDERS RISK. COST SENEFIT ANALYSIS
- PLANT OPERATION OF TECHNOLOGICAL OPTIONS b MAINTENANCE INTEGRATED PLAN '
'l OF POLICY DEVELOPMENT 1
== RELIABILITY ENGINEERING b PLANT AVAILABILITY ESTABLISHING TECHNOLOGICAL PERFORMANCE STANoARDS
- SEVERE ACCIDENT POLICY FOR FUTURE
= FUEL EFFICIENCY l
k EXISTING PLANTS QUALITY ASSURANCE PROGRAMS n= SAFETY GOAL
= EXTENDED PLANT LIFE D OPERATOR TRAINING POUCY
=== OTHER COST FACTORS SAFETY b ENVIRONMENTAL
== SITING POLICY MONITORING
- PouCY ON EMERGENCY PREPAREDNESS Figure 3.
A preliminary framework of incustry and government
_ pot,cy,o, (NUREG 120ET) initiatives that would serve an implicit national ENylRONMENTAL goal of improving the U.S. outlook for maturation PROTECTION progress in nuclear reactor safety technology and the resumption of industry growth.
= Q C,Yj,NjP,ENT WASTE MANAGEMENT Source:
H. R. Denton "The Maturing of the U.S. Nuclear
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Industry". Nuclear Encineerinc and Desian, Vol. 92,
/
- iNTE GR ATED No. 3 (April 1986), 303 322.
1 DE MINIMiS RISK
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POLICY
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WHAT'S'IN A NA.Mi?
THE-CURRENT FAMIL'Y OF RISK' CHARACTERIZATIONS t
i UNACCEPTABLE vs. ACCEPTABLE
.ADEQUATELPROTECTION 0F PUBLIC HEALTH & SAFETY
'HOW SAFE IS SAFE ENOUGH7
. QUANTITATIVE' DESIGN OBJECTIVES (QD0s) vs. QUALITATIVE ST DS. (NRC)
-UPPERJBOUND:ESTIMATESL(EPA)
RESIDUAL. RISK /BEST AVAILABLE CONTROL TECHNOLOGY- (BACT)
COMPARATIVE:(RITTER BILL)
. ABSOLUTE vs. RELATIVE (BEIR III)
' DEMONSTRABLE vs.. INFERRED.
BEYOND DEMONSTRABLE EFFECT.(BDE) - A. WEINBERG THRESHOLD LEVEL STOCHASTICoys. NONSTOCHASTIC
-WORST CASE ACCIDENT;(CEQ)
LOW: PROB'Y/HIGH CONSEQUENCE vs. HIGH' PROB'Y/ LOW CONSEQUENCE PROMPT FATALITY vs. DELAYED FATALI1Y ELIFE SHORTENING MORTALITY vs. MORBIDITY
-CATASTROPHIC vs. DISPERSED / CHRONIC VOLUNTARY vs. INYOLUNTARY
' FAMILIAR vs.:NEW/ DREAD
' ACTUAL vs. PERCEIVED
. PSYCHOLOGICAL STRESS / PHOBIA ENATURAL (BACKGROUND) vs. MANMADE S0MATIC vs. GENETIC / TERAT 0 GENIC N0 UNDUE RISK (NRC)
AS-LOW AS REASONABLY ACHIEVABLE (ALARA)
BELOW REGULATORY CONCERN (BRC)-
SIGNIFICANT vs. INSIGNIFICANT q
DE MINIMIS RISK (DMR) vs. DE MINIMIS CONTAMINATION (DMC)
NEGLIGIBLE INDIVIDUAL RISK LEVEL (NIRL) - NCRP
- VANISHINGLY SMALL ZERO vs. APPROXIMATELY (REASONABI.Y) ZERO - FDA/DELANEY CLAUSE m
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I STANDARD ACTIVITY RISK OF DEATH OR ZONE
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... ACCEPTABLE...
BEING STRUCK BY LIGHTNING (De Minimil Rilk)
I in 1.000.000
+--NATURAL DISASTERS E
TRANS SCIENCE'
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1 in 100.000
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2 ALL INDUSTRIAL UORK
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(A)
DEMONSTRASI.E
.I PROOF
- TRAFFIC ACCIDENTS ALL ACCIDENTS L
(C)
- CLEARLY Z
-UNACCEPTABLE-I in 100
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L Fig. 1.
Probability of death for an individual per year of exposure (orders of magnitude) in tenns of acceptable / unacceptable risk.
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REALMS OF SCIENTIFIC KNOWLEDGE AND.. UNCERTAINTY
~'
i EPISTEMOLOGY: THE-l TRANSITORY LIMIT OF l'
STUDY OF THE LIMITS
~
USEFUL SPECULATION AND VAllDITY OF BASED ON THE APPLICATION KNOWLEDGE OF SCIENTIFIC METHOO o
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_ U o SC PtsNEo IMAG8 NATION j
IMAG4 NATION ~ "
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INFORMATION RESOURCES.
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PURE ART.-
j APPLICATIONS OF SCIENTIFIC METHOC L
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SCIENCE TRANS-SCIENCE j
NON-SCIENCE
.I IREALM OF KNOWLEDGE (REALM OF APPUED j
litEALM OF PRESENTLY AS DEMONSTRABLE JUDGMENT AND j
IMIKNOWASLE TRUTHS ft
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FUTURE OtSCOVERABLEEl j
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///////////////////////////// /
f CERTAINTY -
UNCERTAINTY b
(TRUTH) l DEGREE OF BELIEF DEGREE OF IGNOstANCE O-I i
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' AIBS (/o-/o-85)
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=
r lisTI AirTED ANNt'IAl.' WIH)t.E-lkDUY R ADIATION ' l.k)SE RATES TO Tile POPUl.ATION OF Tile - U.S.*
Average Dose Rates'
~
Source of Radiation
-(mrem / year)
Natural
~
l Enviromnental l
Cosmic Rudiation 40 (30-130)t Terrestrial Radiation 40 (30-115)$
i internal Radioactive isotopes 20 j
Subtotal 100 Man-Made a
Environmental i
Global Fallout 4
~
l Nuclear Power 0.023 l'
Medical Diagnostic 72 l
Radiopharmaceuticals 1
l Occupational 0.8 Miscellaneous 2
!j Sublotal 80 l
-l TOTAL 180
- U.N. Scientific Committee on the Effects of Atomic Radiation & KEENY et 0I.(1973 tValues in parentheses indicate range over which average levels for different states vary _
with elevation.
4 Range of variation (shown in parentheses) attributable largely to geographic differences in the content of potassium-40. radium, thorium, and uranium in the earth's crust.
gValue for 1975.
_ COURT RULINGS NEGATING A ZER0 RISK REQUIREMENT g
FOR SAFETY REGULATIONS BY THE AEC/NRC
- 1. -
U.Si DISTRICT COURT (1973) - NADER v. RAY (AEC)
~
1 ABSOLUTE CERTAINTY OR "COMPLF,TE", " ENTIRE" OR " PERFECT" SAFETY IS NOT REQUIRED BY THE ATOMIC ENERGY ACT, NOR DOES NUCLEAR SAFETY TECHNOLOGY ADMIT OF SUCH A STANDARD.
POWER REACTOR DEVELOPME$T CO. V. INTERNATIONAL UNION, ELECTRICAL WORKERS.
SUPRA:.CF., CROWTHER V. SEABORG, 312 F. SUPP. 1205, 1235 (D.
COLO. 1970).
i 2.
SUPREME COURT (1980) - AFL/CIO v. AMER. PETROLEUM INST.
"[$]AFE" IS NOT THE EQUIVALENT OF " RISK-FREE".
THERE ARE MANY ACTIVITIES THAT WE ENGAGE IN'EVERY DAY-- SUCH AS DRIVING A CAR,OR EVEN BREATHING CITY AIR-- THAT ENTAIL SOME RISK OF ACCIDENT OR MATERIAL HEALTH IMPAIRMENT; NEVERTHELESS FEW PEOPLE WOULD CONSIDER THESE ACTIVITIES " UNSAFE".- [AN ACTIVITY) CAN H.4RDLY BE CONSID.ERED " UNSAFE" UNLESS IT THREATENS... A SIGNI.
FICANT RISK OF HARM.
l 3.
- U.S. DISTRICT COURT (1987) - UCS v. NRC THE LEVEL OF ADEQUATE PROTECTION NEED NOT, AND ALMOST CERTAINLY WILL NOT, BE THE LEVEL OF'"ZERO RISK",
THIS COURT LONG HAS HELD THAT THE ADEQUATE-PROTECTION STANDARD PERMITS THE ACCEPTANCE 0,F 50ME LEVEL OF RISK.
- SEE, E.G., CARSTENS V. NRC, 742 F.2d 1546, 1557 (D.C. CIR. 1984); NORTH ANNA ENVIRONMENTAL C0ALITION V.-NRC, 533 F.2d 655, 665 (D.C. CIR. 1976).
)
3, o WHAT THE COURTS SAY ABOUT.DE'MINIMIS RISK-I.
U.S. DISTRICT COURT (1979) - MONSANTO v. KENNEDY (FDA)
INITIALLY _THE DELANEY CLAUSE AMENDMENT TO THE FDA ACT OF 1958 WAS INTERPRETED AS REQUIRING ZERO RISK FROM ANY F000 ADDITIVE FOUND TO INDUCE CANCER WHEN INGESTED BY ANIMALS OR ilUMANS.
IN 1977 THE FDA BANNED A PLASTIC SOFT-DRINK BOTTLE BECAUSE TRACES OF ACRYLONITRILE (A CARCINOGEN FOR ANIMALS) COULD LEACH INTO.
THE ACID SOFT DRINK. -IN REVIEWING THE CASE, THE COURT OF APPEALS STATED THAT THE ADMINISTRATOR OF FDA CAN IGNORE DE MINIMIS RISKS, NOT WITHSTANDING THE SUPERFICIAL RIGIDITY OF THE DELANEY CLAUSE.
However, a recent circuit court decision of 10-23-87
" reluctantly" concludes otherwise (Public Citizen et al v. Frank Young).
2.
U.S. DISTRICT COURT (1979) - CLEAN AIR ACT/ EPA i
THE STATUTORY 100-TON THRESHOLD FOR DEFINING A MAJOR EMITTING FACILITY DOES NOT NECESSARILY EXCEED.A PERMIS$1BLE DE,MINIMIS LEVEL FOR APPLICATION OF BACT [BEST AVAILABLE CONTROL TECHNOLOGY] REQUIREMENTS UNDER PSD (PREVENT SIGNIFICANT DETERIORATION] PART OF CLEAN AIR ACT AMENDMENTS OF 1977, HOW-EVER THE EPA MUST-FOLLOW A RATIONAL APPROACH TO DETERMINE WHAT LEVEL OF EMISSION IS A RE MINIMIS AM0 BHT AND MAY NOT E
MERELY ADOPT THE STATUTORY THRESHOLD.-
3.
SUPREME COURT (1980) - BENZENE / OSHA (STATEMENT OF JUSTICES STEVENS, BURGER, AND STEWART)
IN THIS CASE THE AGENCY [0SHA] DID NOT HAVE THE BENEFIT OF ANIMAL STUDIES..BECAUSE SCIENTISTS HAVE BEEN UNABLE AS YET TO INDUCE LEUKEMIA IN EXPERIMENTAL ANIMALS AS A RESULT OF BENZENE EXPOSURE.
IT DID, HOWEVER, HAVE A FAIR AMOUNT OF EPIDFMIOLO-GICAL EVIDENCE, INCLUDING BOTH POSITIVE AND NEGATIVE STUDIES.
l ALTHOUGH THE AGENCY STATED THAT THIS EVIDENCE WAS INSUFFICIENT TO CONSTRUCT A PRECISE CORRELATION BETWEEN EXPOSURE LEVELS AND CANCER RISKS, IT WOULD AT LEAST BE HELPFUL IN DETERMINING WHETHER IT,IS MORE LIKELY THAN NOT THAT THERE IS A SIGNIFICANT j
RISK AT 10 PPM.
i
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<<NRC'S !MPLICIT AND EXPLICIT ~USE OFLDE1MINIMIS RISK CONCEPT $i!N:
l
. REGULATING FOR RADIOLOGICAL PROTECTION IN THE NUCLEAR F0EL CYCLE
^
t 9
.ALARA (NON-EQUIVALENCY)
- INTERIM'USE OFL$1000 PER PERSON-REM ID 10-CFR PART 20 REVISION - STANDARDS-FOR PROTECTION AGAINST: RADIATION
- G-REGULATORY-EXEMPTION: LEVELS (NON-EQUIVALENCY)
- S FACILITY DECOMMISSIONING *(NUREG-0436: 1978) j
- DE:MINIMIS-CONTAMINATION LEVEL 19
-URAN'IUM M.INES AND MILLS *
. SOCIETAL vs. INDIVIDUAL RISK PERSPECTIVE
- CUT 0FF CONCEPT R
GF LOW LEVEL. WASTE DISPOSAL
- DMR AT LEVELS-BELOW WHICH THERE IS NO REGULATORY. CONCERN >
- WILL COSTS AND BENEFITS BE T[ KEN INTO ACCOUNT?
G -
SAFETY: GOALS
- NO SIGNIFICANT ADDITIONAL RISK TO LIFE & HEALTH j
- 0.15' ADD'L RISK OF PROMPT & DELAYED FATALITIES FROM ALL L
-CAUSES L
- WITHDRAWAL 0F $1000/ PERSON REM FOR SEVERE ACCIDENT REGULATION-l
- PROPOSED PERFORMANCE GUIDELINE OF A LARGE OFFSITE I
RELEASE OF RADIONUCLIDES AT FREQUENCY LESS THAN 10-6 PER YR. OF REACTOR OPERATION
- EXPLICIT ATTENTION TO DE MINIMIS RISK CONCEPTS 4
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-.-~-..-- - -..-~
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PURPOSE SERVED BY ALARA (10 CFR 20.lc)
.(c) - IN ACCORDANCE WITH RECOMMENDATIONS OF THE FEDERAL RADIATION COUNCIL APPROVED BY THE-PRESIDENT, PERSONS ENGAGED IN ACTIVI-TIES-UNDER LICENSES ISSUED BY THE NUCLEAR REGULATORY COMMISSION PURSUANT TO THE ATOMIC ENERGY ACT OF 1954, AS AMENDED, AN'D T,HE ENERGY REORGANIZATIOP ACT OF 1974 S'HOULD IN ADDITION T0= COMPLYING WITH THE REQUIREMENTS SET FORTH IN THIS PART, MAKE EVERY REASONABLE EFFORT TO MAINTAIN' RADIATION EXPOSURES AND RELEASES OF RADIDACTIVE MATERIALS IN EEFLUENTS T0-UNRESTRICTED AREAS Jus LOW AS IS REASONABLY ACHIEVABLE.- THE TERM'AS LOW AS IS REASONABLY ACHIEVAB1E MEANS AS LOW AS.IS REASONABLY ACHIEVABLE TAKING INTO ACCOUNT THE-STATE OF TECHNOLOGY, AND THE ECONOMICS OF IMPROVEMENTS IN RELATION TO BENEFITS T0'THE PUBLIC-HEALTH AND SAFETY, AND OTHER SOCIETAL AND SOCI0 ECONOMIC CONSIDERATIONS AND IN RELATION TO THE UTILIZATION OF ATOMIC ENERGY IN THE PUBLIC INTEREST.
4
is, u
ALARA QUANTITATIVE DESIGN OBJECTIVES' (10 CFR 50, APPENDIX I)
(1)
LIMIT THE AMOUNT OF RADI0 ACTIVITY RELEASED IN LIQUID EFFLUENTS FROM ANY LIGHT-WATER-COOLED POWER REACTOR TO LEVELS THAT WOULD-KEEP THE ANNUAL EXPOSURE TO AN INDIVIDUAL IN AN UNRESTRICTEC AREA TO NOT MORE THAN 3 MILLIREMS FOR THE WHOLE BODY AND NOT MORE THAN 10 MILLIREMS TO ANY ORGAN.
"(2)
LIMIT RELEASES OF RADIOACTIVITY IN GASEOUS EFFLUENTS FROM ANY LIGHT-WATER-COOLED POWER REACTOR TO KEEP ANNUAL EXPOSURES 70 AN INDIVIDUAL IN AN UNRESTRICTED AREA TO A MAXIMUM OF 5 MILLI-REMS TO THE WHOLE BODY, AND NOT MORE THAN-15 MILLIREMS TO THE SKIN.
(3)
LIMIT RELEASES OF RADI0 ACTIVE IODINE AND OTHER RADI0 ACTIVITY FROM ANY LIGHT-WATER-COOLED POWER REACTOR TO KEEP ANNUAL EXPOSURES TO THE THYROID OF AN' INDIVIDUAL IN AN UNRESTRICTED AREA TO NOT MORE THAN 15 MILLIREMS.
UNACCEPTABLE PUBLIC RISK (ALARA)
THROUGH THE USE OF ALARA, NRC HAS SET-THE STANDARD FOR LIMITING THE AGGREGATE RADIOLOGICAL RISK TO AN INDIVIDUAL IN THE PUBLIC FROM ALL SOURCES OF RADIATION EXCEPT NATURAL BACKGROUND AND MEDICAL ~3URCES TO AN UPPER BOUND OF 500 MREMS OF ANNUAL EXPOSURE.
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~ EXPLICIT PROPOSAL FOR DE' MINIMIS RISK USAGE IN 10 CFR-PART 20' m
REVISION 0N STANDARDS FOR PROTECTION AGAINST RADIATION ( APRIL 1985)
"THE NEED HAS LONG BEEN RECOGNIZED FOR A DE MINIMIS FEATURE IN THE
-STANDARDS FOR PROTECTION AGAINST RADIATION IN ORDER TO AVOID EXTEND-ING PEGULATORY ACTIONS BEYOND WHAT IS NEEDED TO ADEQUATELY PROTECT PUBLIC HEALTH.
HOWEVER, IHE PRESENT PART 20 PROVIDES-NEITHER A DE 1
MINIMIS LEVEL FOR THE MOST EXPOSED INDIVIDUAL MEMBER OF THE PUBLIC, NOR. A LEVEL-FOR THE CUTCFF OF COLLECTIVE DOSE CALCULATIONS. THE LACK 0F THESE LEVELS-IN RADIATION PROTECTION STANDARDS HAS RESULTED IN UNWARRANTED EXPENDITURES OF RESOURCES FOR INCREMENTAL RISKS WHICH ARE CONSIDERED TRIFLES IN COMPARISON TO THE RISKS WHICH INDIVIDUALS ARE SUBJECTED T0 DAILY AS PART OF NORMAL LIVING HABITS AND ACTIVITIES."
U "THE SUPPLEMENTARY INFORMATION OF THE PROPOSED. REVISION OF PART 20 DISCUSSES THE POSSIBILITY OF A PROVISION WHICH WOULD DEFINE A DE MINIMIS SOURCE OF RADIATION AS ONE WHICH WOULD BE UNLIKELY TO CAUSE
.)
L; ANY INDIVIDUAL TO RECE'IVE A DOSE.IN EXCESS OF 0.001 REM IN A VEAR....
THIS CONCEPT OF DE MINIMIS HAS RECEIVED FAVORABLE ENDORSEMENT FROM BOTH THE TECHNICAL AND LEGAL STANDPOINTS."
l.
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MODIFIED VERSION PUBLISHED JAN. 9. 1986 FOR PUBLIC COMMENT (51 FR 1092)
"A MORE LIMITED APPLICATION OF THE DE MINIMIS CONCEPT HAS BEEN i
PROPOSED.
FOLLOWING CONSIDERATION OF LOWER AND HIGHER NUMBERS, A VALUE OF 0.001 REM (0.10 mSv) PER YEAR WAS SELECTED FCP LIMITING THE EXTENT OF EVALUATING COLLECTIVE DOSES TO POPULATIONS.
APPLICATION 0F THE DE MINIMIS LEVEL TO COLLECTIVE DOSE ESTIMATES WOULD, AMONG l
OTHER THINGS, LIMIT BOTH THE SIZE OF THE POPULATION AND THE TIME F
OVER WHICH. COLLECTIVE DOSE WOULD NEED T0 BE CONSIDERED IN EVALUATING ACTIVITIES ASSOCIATED WITH THE RELEASE OF RADIDACTIVE MATERIALS TO L
THE ENVIRONMENT."
(NOTE THE PROPOSED APPLICATION OF THE DE MINIMIS CONCEPT COUI.D L
HAVE A SUBSTANTIAL INFLUENCE ON THE EVALUATIONS OF CONDITIONS WHERE I
YERY LARGE NUMBERS OF PEOPLE ARE SUBJECTED TO VERY LOW D0sd RATES.
IN ESSENCE THE PROPOSED RULE WOULD SUGGEST DISREGARDING EXTREMELY LOW DOSE RATES (0.001 REM PER YEAR) WITHOUT REGARD TO THE NUMBER OF PEOPLE EXPOSED AT THAT LEVEL OR LESS.)
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DE MIN! MIS CONTAMINATION STANDARDS AND RESIDUE LEVELS FOR FACILITY MA DECOMMISSIONING i
g FROM NUREG.0436 (1978):
5.3 PRINCIPAL !$ SUES IN DECOMMIS$iONING_Ppl!CY THE PRINCIPAL ISSUES TO BE ADDRESSED IN DEVELOPING QR REEVALUATING DECOMMISSIONING POLICY ARE THE ACCEPTABILITY 0F RADI0 ACTIVE kLSIDUE LEVELS (!.E., DE MINIMIS CRITERIA) AND THE FINANCIAL ASSURANCE.
MUCH OF THE IN' FORMATION NEEDED FOR CUR POLICY DEVELOPMENT CAN COME FROM THE WORK OF CONTRACTORS, BUT IN THESE PRINCIPAL AREAS DIRECT AND PARTICULAR ATTENTION SY THE NRC STAFF IS VERY'IMPORTANT.
j FROM REG. GUIDE I.86:
FOR UNRESTRICTED RELEASE AND USE OF PLANT DECOMMISSION MATERIALS A
' DOSE EXPOSURE R' ATE OF 10 MREM /YR OR LESS IS REQUIRED OR SURFACE
)
ACTIVITY RATES OF 5X10-6 gjgg, DEFIN! TION'0F 'DE MINIM!$ CONTAMINATION" CE MINIMIS LEVELS ARE THOSE LEVELS OF RADI0 ACTIVE CONTAMINATION THAT ARE S0 LOW THAT THE $1TE OR OBJECT S0 CONTAMINATED MAY BE RELEASED WITHOUT FURTHER CONCERN OR RESTRICTION TAKEN FROM THE LATIN:
DE MIN'! MIS NON CURAT LEX (THE LAW'00ES NOT DEAL WITH TRIFLES).
l MEASUREMENT PROBLEM AS STATED IN NUREG-0436 (REV, 1):
IN REGARD TO RESIDUAL RADICACTIVITY LEVELS (I.E., DE H!A! MIS VALUES)
IT WAS COMMENTED THAT THE DOSE VALUES OF 1 TO 25 MREM A5 USED AS AN ILLUSTRATIVE EXAMPLE IN THE NUREG REPORTS PRESENTED, WERE TOO LOW.
AND IMPRACTICAL BECAUSE OF DIFFICULTY IN MEASUREMENTS AT THESE TWO LEVELS.
OTHER CONCERNS (FROM PUBLIC WORKSHOPL1 e THE PROBLEM OF DEFIN!NG BACKGROUND INCLUDING ANY CHANGES OVER THE LIFE OF THE FACILITY, e THE ENFORCEABILITY BECAUSE S0 CLOSE TO BACKGROUND.
- THE SIZE AND TYPE OF THE POPULATION THAT WOULD BE AFFECTED.
e THE STANDARD SHOOLD REFLECT THE DURATION OF EXPOSURE.
O.THE RELATION OF THE MAXIMUM DOSE RATE TO A HEALTH EFFECT..
[
huMERICAL SAFETY G0ALS AND SEVERE ACCIDENT RISK GUIDELINI (51 FR 28044)
~
QUANTITATIVE DESIGN OBJECTIVES (000s1.
I O
THE R!$K TO AN AVERAGE INDIVIDUAL IN THE Y!CINITY OF A NUCLEAR POWEt PLANT OF PROMPT FATALITIES THAT MIGHT RESULT FROM REACTOR i
ACCIDENTS SHOULD NOT EXCEED ONE-TENTH OF 15 (0.15) 0F THE SUM OF PROMPT FATALITY RISKS RESULTING FROM OTHER ACCIDENTS TO WHICH MEMBERS OF THE U.S. POPULATION ARE GENERALLY EXPOSED.
9 THE RISK TO THE POPULATION IN THE AREA NEAR A NUCLEAR POWER l
PLANT OPERAT!0H SHOULD NOT EXCEED ONE-TENTH OF 15 (0.15) 0F
+
THE SUM 0F CANCER FATALITY RISKS RESULTING FROM ALL OTHER CAUSES.
l PROPOSED PERFORNANCE GUIDELINE:
CONSISTENT WITH THE TRADITIONAL DEFENSE-!N-DEPTH APPROACH AND THE ACCIDENT MIT!GATION PHILOSOPHY REQUIRING RELIABLE PERFORMANCE 0F CONTAINMENT SYSTEMS, THE OVERALL MEAN FREQUENCY 0F A LARGE R.ELEASE OF RADICACTIVE MATERIALS TO THE ENVIRONMENT FROM.A REACTOR ACCIDENT SHOULD BE LESS THAN 1 IN 1,000,000 PER YEAR OF REACTOR OPERATION.
COMPARISON TO COMMod USAGE OF DE MINIMIS RISK LEVELS:
i G
PROMPT FATALITY 000 A1 0.15 0F BA.CKGROUND LEVEL IS'AN INDIVIDUAL RISK OF FATALITY OF 4 X 10~7 /YR VS.10-6 DMR STANDARD.
O CANCER FATALITY 000 AT 0.15 0F BACKGROUND LEVEL IS AN INDIY! DUAL RISK OF FATALITY OF 2 X 10-6 /YR, OR TWICE DMR STANDARD.
O PROPOSED PERFORMANCE GUIDELINE AT 10~0 EVENTS /YR EQUALS THE DMR STANDARD AT THE EXTREME (AND UNREALISTIC) ASSUMPTION THAT ALL INDIVIDUALS RECEIVING ANY DOSE WOULD SUFFER PROMPT OR
~
DELAYiD FATALITY.
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RISK CONCLUSIONS FROM THE FINAL ENVIRONMENTAL IMPACT STATEMEt:T ON URANIUM NINING (NU_ REG-0706. 1980)
- 9 THE MOST SIGN!FICANT IMPAC1 FROM MILL OPERATIONS UNDER THE BASE CA$E WOULD OCCUR FROM PER$1 STENT RADON RELEASES FROM l
THE UNCOVERED TAILINGS.
ABOUT 6000 PREMATURE DEATHS ARE CALCULATED OVER THE PERIOD 1979 TO 3000 IN THE UNITED STATES, CANADA, AND MEXICO FROM TAILINGS WHICH WOULD BE GENERATED BY
'THE FULL OPERATION 0F MILLS 'IN THE U.S. THROUGH THE YEAR 2000.
THE CUMULATIVE POTENTIAL IMPACTS CONSTITUTE A 1.2 X 10-5 FRACTION OF THE OVERALL U.S. INCIDENCE OF CANCER.
(THIS LEVEL OF AVERAGE INDIVIDUAL PISr IS ALMOST TWO ORDERS OF MAGNITUDE, I.E., 80 TIMES LESS THAN THE AVERAGE LEVEL OF LATENT CANCER FATALITY RISK TO THE POPULATION IN THE VICINITY OF A NUCLEAR F0WER PLANT FROM A SEVERE ACCIDENT, AS STATED IN NRC'S PROPOSED SAFETY GOAL-- NAMELY, A 10~3' FRACTION OF BACKGROUND LATENT CANCER FATALITIES.)
l O
THE CONTINUING ANNUAL RATE OF PREMATURE DEATHS FROM THIS VOLUME OF TAILINGS IS ESTIMATED TO BE ABOUT SIX PER YEAR.
THIS ANNUAL RATE COULD BE USED TO DEVELOP ESTIMATES OF HEALTH EFFECTS BEYOND 1000 YEARS IF THIS WE'RE DESIRED: THIS WOULD REQUIRE MAKING VERY UNCERTAIN ASSUMPTIONS ON LONG-TERM FACTORS SUCH AS CLIMATE, POPULATION GROWTH, AND THE LIKE.
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LICENSING A'ND APPEAL BOARD 2.ND COMMIS$f0N CONCLUS!0iS ON MILL TAILINGS RIS'K FOLLOWING ENVIRONMENTAL HEARINGS IN THE LICENSING f
0F NUCLEAR POWER PLANTS _
f ASLS CONCLUSION (4 NRC 87 1978):
IN A PROCEEDING TO DETERMINE WHETHER PERMISSION TO CONSTRUCT A l
NUCLEAR FACILITY SHOULD BE GRANTED, THE LICENSING BOARD CONSIDERED THE $1GNIFICANCE 0F RADON GAS RELEASES IN THE CONTEXT OF AN l
ENVIRONMENTAL COST-BENEFIT ANALYS!$.
THE LICENSING BOARD FOUND l
,THAT THE CALCULATED HEALTH EFFECT THAT MIGHT RESULT-- HALF A DEATH
{
PER YEAR IN A POPULATION OF 300 MILLION-- WAS A MINIMAL IMPACT.
PROPERLY STABILIZED MILL TAILINGS P!LES AND RECLAIMED URAN!UM l
MINES WOULD MAKE THE IMPACT 100 TIMES LOWER.
THE BOARD CONCLUDED THAT THE BEST MEANS OF CHARACTERIZING THE $1GNIFICANCE OF RADON RELEASES ATTRIBUTABLE TO OPERATION OF THE FACILITY WAS TO COMPARE THEM WITH THOSE ASSOCIATED WITH NATURAL BACKGROUND RADIATION AND 175 FLUCTUATIONS.
THE INCREMENTAL RELEASES ATTRIBUTABLE TO THE FACILITY WERE SC SMALL AS TO BE COMPLETELY UNDETECTABLE.
- THUS, THE BOARD CONCLUDED THAT THE!R IMPACT COULD NOT BE $1GNIFICANT.
APPEAL 80ARD CONCLUSIONS:
IN SEVERAL OTHER LICENSING CASES INVOLVING THE SAME ISSUE, THE
]
APPEAL BOARDS REFERRED TO THE LICENSING BOARD'S DECISION AS EMPLOYING A g MINIMIS, APPROACH, 13 NRC 487 (1981).
IN A MORE RECENT DECISION CONCERNING THE HEALTH EFFECTS OF RADON GAS RELEASES, THE APPEAL BOARDS MADE NO REFERENCE TO THE DE MINIMIS i
RATIONALE.
THEY RETAINED THE COMPARISON TO NATURAL 8ACXGROUND RADIATION, HOWEVER, AND CONCLUDED THAT THE INCREMENTAL HEALTH RISK TO THE POPULATION STEMMING FROM THE FUEL CYCLE EMISSIONS (!F l
INDEED THERE IS ANY) IS VANISHINGLY SliALL,16 NRC 1528 (NOVEMBER 19, 1982).
THE APPEAL BOARDS FOUND THAT THE RADON RELEASES
(
ATTRIBUTABLE TO A SINGLE 1000-MCGAWATT (ELECTRIC) NUCLEAR REACTOR WOULD CAUSE AN INCREASE IN DOSE TO THE BRONCHIAL EPITHELIUM OF FROM.0.0005 TO 0.005 MILLIRCM PER YEAR.
THIS IS FAR BELOW THE 480 MILLIREM PER YEAR DELIVERED TO THE BRONCHIAL EPITHELIUM BY TYP! CAL OUTD0OR RADON LEVELS FROM BACKGROUND SOURCES.
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LICENSING AND APPEAL BOARD AND COMMISSION CONCLUSIONS ON MILL
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TAILINGS RISK F0LLOWING ENVIRONMENTAL HEARINGS,1N THE LICENSING
{
OF NUCLEAR POWER PLANTS - (CONTINUED) i I
COMMIS$10N CONCLUSION THE COMMIS$10N HAS SQUARELY REJECTED THE ARGUMENT THAT THE RISKS POSED BY URAN!UM MILLING ARE DE MINIMIS.
IN DENYING A STAY OF ITS LICEMSING REQUIREMENTS FOR URANIUM MILLING SOUGHT BY SEVERAL l
MILL OPERATORS AND THE STATE OF NEW MEXICO. THE COMMIS$10N EXPLAINED
- RADON IS THE PRIMARY SOURCE OF LONG-TERM PUBLIC EXPOSURE TO RADIATION RESULTING FROM URANIUM MILLING.
IF ADEQUATE MEASURES ARE NOT TAKEN TO CONTROL RADON EMISSIONS FROM MILL TAILINGS PILES. THE PUBLIC EXPOSURE T0-THE SOURCE WOULD EXCEED ITS EXPOSURES TO ALL THE OTHER RADIATION SOURCES ASSOCIATED WITH THE URANIUM FUEL CYCLE, 13 NRC 460 (1981).
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FOUR PERSPECTIVES RELEVANT TO AN APPROACH TO ESTABLISMING f
AN ACCEPTABLE STANDARD OR DE MINIMIS RISK l
(1)
REJECTION OF CERTAIN WORST CASE NUCLEAR ACCIDENT SCENARIOS BECAUSE THEIR PROBASILITY IS SO LOW AS TO PLACE THEM IN THE I
- NOISE" LEVEL OF THE RANGE OF UNCERTAINTY OF THE MORE DOMINANT ACCIDENT SEQUENCE CONTRIBUTORS TO THE OVERALL COMPUTATION OF SEVERE ACCIDENT RISK (PRA PRACTICE) l (2)
COMPARATIVE RISK ANALYSIS OF NUCLEAR AND ALTERNATIVE VIABLE ENERGY SOURCES FOR GENERATING ELECTRICITY (QUALITATIVE SAFETY l,
G0AL)
(3)
COMPARISON OF THE NUCLEAR FUEL CYCLE RISK'0F REGULATORY OPTIONS WITH THE EXPECTED COST OF POTENTIAL COUNTERMEASURES THAT WOULD RESTORE THE MARGIN OF LONGEVITY REDUCTION (4)
COMPARISON OF THE NUCLEAR FUEL CYCLE RISK OF REGULATORY OPTIONS WITH THE RISK LEVELS INDIVIDUALS REGARD AS NEGLIGISLE OR DE MINIMIS IN THEIR DAY-TO-DAY ACTIVITIES OR DECISIONS e
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TOWARD AN INTEGRATED POLICY FOR DE MINIMIS RISK APPLICATIONS A,5 PART OF AN OVERALL TEMPLATE OF NRC REGULATORY PHILOSOPHY OF RAD 10 LOGICAL PROTECTION
\\
1.
CSTABLISH THE RELATIONSHIP BETWEEN A DE MINIMIS RISK (DMR) l STANDARD AND OTHER RISK ACCEPTANCE APPROACHES OR NUMERICAL RISK SENCHMARKS OR LIMITS e
SAFETY GOALS (QUALITATIVE & QUANTITATIVE)
THE ALARA PROCEDURE AND RADIOLOGICAL PROTECTION LIMITS e
A TIER-1 AND TIER-2 STRUCTURE OF GUIDELINES OR STANDARDS
)
FOR $EVERE ACCIDENT SAFETY REGULATION (YET TO BE DEVELOPED) 2.
ESTABLISH AN APPROACH AND RATIONALE FOR DETERMINING
~
FIGURE ($) 0F MERIT FOR A DMR STANDARD 3.
CONSIDER HOW STEPS 1 & 2 WOU!.D SERVE SIMILAR OR DISPARATE NEEDS OF ALL NRC 0FFICES ENCOMPASSING'THE NUCLEAR FUEL CYCLE 4.
CONSIDER H0k STEPS 1 & 2 RELATE TO PAST COURT RULINGS AFFECTING REGULATORY STANDARDS OR PROCEDURES AS WELL AS NRC CASE-RELATED OR GENERIC DECISIONS THAT FOCUSED ON DMR l
OR OTHER LOW-LEVEL RISKS 5.
SEEK TO RECONCILE AN INDIVIDUAL DMR PERSPECTIVE WITH AN AGGREGATE SOCIETAL RISK PERSPECTIVE 6.
SEEK TO RECONCILE THE NRC TEMPLATE OF SAFETY PHILOSOPHY WITH APPROACHES OF OThER FEDERAL AGENCIES (NOTABLY EPA AND OSTP)
C00RDINATIVE MEETINGS e
UNIQUENESS OF STATUTORY REQUIREMENTS AND HISTORY OF COURT RULINGS m.
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November 24, 1987 Murley, NRR g '" * * /
Jordan, AEOD or tact o' f at Murray, OGC/B 88 C "" Y Ebneter, OSP MN'AN MEMORANDUM FOR:
Victor tello, Jr., Executive Director for Operations FROM:
8And'rewL. Bates,ActingSecretary
SUBJECT:
SECY-87-186A DISTRIBUTION OF RADIDACTIVE GEMS 1RRADIATED IN REACTORS TO UNLICENSED PERSONS (FDLLOW-UP TO SECY-87 186)
This is to advise you that the Comission (with Comissioners Roberts.ld Bernthal, Carr and Rogers agreeing) has approved Option 3(b) which wou l
allow issuance of interim licenses for distribution of irradiated gemstones pursuant to 10 CFR 32.11, with an exemption from that portion of Section 32.11(c) which prohibits application of products to a human being.
Meanwhile, staff is directed to develop a proposed Comission policy statement that will identify a level of radiation risk below which government regulation becomes unwarranted. Implementation of this policy would be accomplished by specific regulations for the various classes of l
materials, including gemstones. Appropriate resources should be devoted to accomplish this task with consideration given to the framework which RES currently has under development.
In coordinating this ' fresh look' at the se minimis or below regulatory concern question, staff should ensure participation of all affected offices.
l A status report / options paper on this issue should be provided for Comission review by January 29, 1988. In order to facilitate the consistency of this policy and implementation for consumer products with other related activities, the paper should address the status of the ANPR on 'below regulatory concern' LLW, i
l residual contamination limits, and the many 'de facto de minimis* levels already in effect. A Comission briefing on this papeTw111 De scheduled for February (SECY SUSPENSE: 1/29/88) $ 7(( /9 45004 (RES)
Also, to ensure that there is no confusion among licensees about the l
l Comission's position on this matter, the staff should comunicate the need for license authoritation to licensees.
(4004 (SECY SUSPENSE: 12/21/87) p?( / / )
(NMSS)
Chairman Zech approved Option 2(b) unless the staff is highly confident that L
the radiation associated with consumers' use of irradiated gemstones will not exceed any de minimis level which the staff expects to establish.
If the staff ha T this confidence, then he would support Option 3(b) and J
agree with the coments noted above.
Date i
Time M %i40a M M P'
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2 The staff is also directed to expedite consideration of NRC policy options with respect to repulation of naturally occurring and accelerator produced radioactive material (NARM).
{ 70 j y y. pr f>
Consnissioteers Roberts and Carr also note that the key issue in this case is the staff's conclusion that the product poses an acceptably small radiological hazard and that there is minimal or no risk to the public health and safetyi not because this " approach would be to allow an established, multi-million'Tollar industry to continue operations..." as suggested in SECY-87-186A.
Additional coments of Chaiman Zech and Comissioners Roberts, Bernthal, Carr and Rogers were provided to you with their vote sheets.
Copies:
Chatman Zech Comissioner Roberts Comissioner Bernthal Comissioner Carr Comissioner Rogers OGC GPA l
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UNITED STATES NUCLE AR REGULATORY COMMISSION
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Novembe r 24. 1987
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$sCAETARY MEMORANDUM FORT Victor tello, Jr. Executive Director for Operations
[hdrewL. Bates.ActingSecretary FPOM:
i
SUBJECT:
SECY-87 186A - DISTRIBUTION OF RADI0 ACTIVE GEMS IRRADIATED IN REACTORS TO UNLICENSED PERSONS i
(FOLLOW-UP TO SECY-87-186)
This is to advise you that the Commission (with Comissioners Roberts.
Bernthal. Carr and Rogers agreeing) has approved Optior< 3(b) which would l
allow issuance of interim licenses for distribution of irradiated gemstones pursuant to 10 CFR 32.11, with an exemption from that portion of Section 32.11(c) which prohibits application of products to a human being.
Meanwhile, staff is directed to develop a proposed Comission policy statement that will identify a level of radiation risk below which government regulation becomes unwarranted.
Implementation of this policy would be accomplished by specific regulations for the various classes of materials, including gemstones. Appropriate resources should be devoted to accomplish this task with consideration given to the framework which RES currently has under development.
In coordinating this " fresh look" at the de minimis or below regulatory concern question, staff should ensure parIicipation of all affected offices.
A status report / options paper on this issue should be provided for Cemmission review by January 29, 1988.
In order to facilitate the consistency of this policy and implementation for consumer products with other related activities, the paper should address the status of the ANPR on "below regulatory concern" LLW.
residual contamination limits, and the many "de facto de minimis" levels already in effect. A Comission briefing on this papei will be scheduled for February (SECY SUSPENSE: 1/29/88)
(E00)
Also, to ensure that there is no confusion among licensees about the Comission's position on this matter, the staff should comunicate the need for license authorization to licensees.
(EDO)
(SECY SUSPENSE: 12/21/87)
Chairman Zech approved Option 2(b) unless the sta#f is highly confident thet I
the radiation associated with consumers' use of irrediated gemstores will not exceed any de minimis level which the staff expects to establish.
If the staff hat this confidence, then h'e would support Optien 3(b) and agree with the coments noted above.
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The staff is also directed to expedite consideration of NRC Dolicy options i
with respect to regulation of naturally occurring and accelerator-produced radioactive material (NARM).
Comissioners Roberts and Carr also note that the key issue in this case is the staff's conclusion that the product poses en acceptably small radiclogical hazard and that there is minimal or no risx to the
(
i public health and safety; ~not because this " approach would be to allow an established, multi-million 7611er industry to continue operations..." as suggested in SECY-87-186A.
Additional coments of Chairman Zech and Comissioners Roberts. Bernthal. Carr 3
and Rogers were provided to you with their vote sheets.
1 4
Copies:
Chaiman Zech Comissioner Roberts 1
Comissioner Bernthal Comissioner Carr Comissioner Rogers OGC GPA 1
I I-t 1
NOTAT10N V0TE i
s RESPONSE SHEET g
)
N T0:
SAMUEL J. CHILK, SECRETARY OF THE COMMISSION 1
FROM:
CHAIRMAN ZECH
SUBJECT:
SECY-87-186A - D.lSTRIBUTION OF RADI0 ACTIVE GEMS IRRADIATED IN REACTORS TO UNLICENSED PERSONS (FOLLOW-UP TO SECY-87-186)
APPROVED DISAPPROVED ABSTAIN NOT PARTICIPATING REQUEST DISCUSSION i
l COMMENTS:
- I aoprove Optior 2(B) which suspends distribution of irradiated gemstones while developing a policy statement and inplementing rules unless the staff is highly confident that the radiation associated with consurers' l
use of irradiated gemstones will not exceed any de rinimis level which the staff expects to establish.
If the staff has this confidence that there is no significant health risk associated with the gemstones, then I would support Option 3(b).
In any case. I believe staff should move expeditiously towards rulemaking, k W.
SIGNATURE ()
O t 0 A 54t ~
DATE YES N_Q ENTERED ON "AS"
/
/
/
/
l NRC-SECY FORM-MAY, 987 l
NOTATION VOTE c
i RESPONSE SHEET i
T0:
SAMUEL J. CHILK, SECRETARY OF THE COMMISSION 7
FROM:
COMMISSIONER BERNTHAL i
SUBJECT:
SECY-87-186A - DISTRIBUTION OF RADI0 ACTIV IRRADIATED IN REACTORS TO UNLICENSED PER (FOLLOW-UP TO SECY-87-186) j I
APPROVED DISAPPROVED ABSTAIN NOT PARTICIPATING REQUEST DISCUSSION
$d tg a_-fro t 1.%d Cw:wYT.
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e x-Jls SIGNATURE l e [ac e [s? r
/DATE /
Xfd
!!Q ENTERED ON "AS"
/
//
/
NRC-SECY FORM MAY, 1987
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Coments of Comissioner Bernthal on SECY 87186:
I approve option 3 (b). Staff should move expeditiously and devote the necessary resources to the development of a Below Regulatory Concern policy i
and appropriate implementing regulations.
In doing so staff should take a hard look at NRC regulatory philosophy with respect to all consumer products.
I believe the Comission should move away from judgments as to what is or is not a " frivolous" application and focus solely on the whether the risk to l
the public health and safety. is acceptable (below regulatory concern) or not.
l My position remains unchanged from that expressed in my last vote on this subject:
"The Comission needs to take a comprehensive look at the best means of establishing a quantitative lower limit or " floor" to ALARA. Equitable and effective regulation demands a rational basis for determining what requires regulation and what does not. This is a significant policy initiative, not unlike Safety Goals, and one that no other regulatory agency has thus far been willing to address. The Comission should not continue to postpone this long overdue, albeit difficult policy judgment.
" Staff should therefore be directed to take a fresh look at the 'de minimis' or 'below regulatory concern' question. The ED0 should be directed to coordinate among all affected offices a status report / options paper on this issue for Comission review by December 31, 1987. This paper should address, among other things, the status of the ANPR on below regulatory concern LLW, residual contamination limits, and the many "de facto de minimis" levels already in effect. A briefing on this paper, conducted by representatives of all affected offices, should then be scheduled in January."
Beyond that, I note that accelerator-enhanced topaz also contains measurable amounts of induced radioactivity, and would not, under current law, be covered by any NRC regulations developed pursuant to Comission action on this SECY. States will therefore apparently need to grapple individually with the sam policy inconsistency and regulatory gap that confronts the Comiscion. Given this situation, and absent any urgent public health and safety finding that would justify imediate action. I again urge Staff (as I did earlier this yeer) to expedite consideration of NRC policy options with respect to regulatioh of Naturally-occurring and Accelerator-produced radioactive material. Or NARM. Whatever risks these stones do or do not l
present to the public, similar hazards should be addressed with similar and consistent regulation.
4 i
if NOTATION V O T E'
)
RESPONSE SHEET J
i TO:
SAMUEL J. CHILK, SECRETARY OF THE COMMISSION FROM:
COMMISSIONER ROGERS i
SUBJECT:
SECY-87-186A - DISTRIBUTION OF RADIOACTIVE GEMS IRRADIATED IN REACTORS TO UNLICENSED PERSONS (FOLLOW-UP TO SECY-87-186)
I i
APPROVED (S B ) kut.-
DISAPPROVED ABSTAIN 5
NOT PARTICIPATING REQUEST DISCUSSION COMMENTS: g 4g Q l
E i
b-SIGNATURE 4 to,(???
DATE YES NQ i
t ENTERED ON "AS"
/
/
/
/
NRC-SECY FORM MAY, 1987
l 4
Comments:
l I approve Option 38. In this ! agree with Comissioner Bernthal's coments.
In particular I support: (a) the development of a policy l
statement for a generally applicable de minimus dose together with a specific implementing rule for gemstonest (b) I do not believe the Comission should attempt to judge the appropriateness of particular j
applications of nuclear materials. The staff should review the current NRC policy which identifies as unacceptable certain types of consumer productscontainingradioisotopeswidelyavailabletothepublictand(c)I support his call for NRC review of its options with respect to regulation of naturally occurring and accelerator produced radioactive materials of any kind, i
M.i A
wan T
v
r L
NOTATION VOTE RESPONSE SHEET TO:
SAMUEL J. CHILK, SECRETARY OF THE COMMISSION l
l FROM:
COMMISSIONER CARR s
SUBJECT:
SECY-87-186A - DISTRIBUTION OF RADI0 ACTIVE GEMS IRRADIATED IN REACTORS TO UNLICENSED PERSONS (FOLLOW-UP TO SECY-87-186)
(
$U DISAPPROVED ABSTAIN APPROVED -
NOT PARTICIPATING REQUEST DISCUSSION COMMENTS:
See attached comunents.
, nz* h b SIGNATURE ll. t o 17 DATE YES M
ENTERED ON "AS"
/N /
/
/
NRC-SECY FORM MAY, 1987 w.
i 4'
4 COMMIS$10NER CARR'S COMMENTS ON SECY-87-186A Approve Option 3b.
i
! do not agree with staff's analysis in SECY 87-186A that a key consideration in the adoption of Option 3b is to circumvent economic t
hardship related to the product in question. Rather they key issue centers on the staff's conclusion that the product poses an acceptably small radiological hazard.
l Also, in this regard, I favor innedf ate staff attention to the development of a policy statement which recognizes the existence of radiation risks that are too low to justify governmental regulation and attention. This policy statement should be developed giving consideration to the framework which RES currently has under development that was briefly described to the Commission during the September 3, 1987 meeting on the Status of Decommissioning Activities. Appropriate resources should be devoted to i
accomplish this task. Staff should then reexamine the regulatory policy t
regarding consumer products to focus on whether regulatory controls are justified on the basis of risk posed by such products to the public health l
I agree with Commissioner Bernthal that staff should provide and safety.
the Commission with a report of the progress on this effort by the end of December.
To ensure that there is no confusion among licensees sbout our current policy, the staff should connunicate the Commission's position on this matter, particularly with respect to the need for license authorization.
6
+
I 4
1 l
e
-__.--.._.,_.s.
y.
[
NOTATION VOTE RESPONSE SHEET i
TO:
SAMUEL J. CHILK, SECRETARY OF THE COMMISSION FROM:
COMMISSIONER ROBERTS
SUBJECT:
SECY-87-186A - DISTRIBUTION OF RADI0 ACTIVE GEMS IRRADIATED IN REACTORS TO UNLICENSED PERSONS (FOLLOW-UP TO SECY-87-186)
APPROVED Xl DISAPPROVED ABSTAIN NOT PARTICIPATING,
REQUEST DISCUSSION COMMENTS:
I approve option 3b based on the low radioactivity of-the gems and thus minimal or no risk to the public's health and safety and not because this " approach would be to allow an established, multi-mTTlion dollar industry to continue operations..." (See SECY-87-186A page5)
I agree with Commissioner Bernthal that we need a policy statement on "de minimus";see my previous vote (enclosed). p j
_j s
W IGNATURE
/) &f)
L
'DATE YES
!LO, l
ENTERED ON "AS"
/
/
/
/
NRC-SECY FORM MAY, 1987
j NOTAT10N VOTE l
l RESPONSE SHEET i
T0:
SAMUEL J. CHILK, SECRETARY OF THE COMMISSION l
FROM:
. COMMISSIONER ROBERTS l
SUBJECT:
SECY-87-186 - DISTRIBUTION OF RADI0 ACTIVE GEMS l
IRRADIATED IN REACTORS TO UNLICENSED PERSONS l
APPROVED DISAPPROVED ABSTAIN
\\
NOT PARTICIPATING REQUEST DISCUSSION i
COMMENTS Although I might be sygathetic with the staff's roccmmandations, I find the technical analysis waak. Before the issue is brought back to the Comission I would like to know: 1) the details of the enforcement action halting imort of radioactive topas gems from Brazil, 2) the t
current position of the Nuclear Energy Agency in this matter and 3) the i
tmC resources allocated to cooperate with the U.S. Custczns Service.
)
I would also like to note that once again the Ca mission is faced with an issue that could be easily resolved had we had in place the "de minims" levels critaria.
It is my understanding that the staff has
{
been working on this for same time. Should it not be time for the 1
Camission to receive an integrated and ccmsistant "de mininus" levels j
1 Policy? %
l
~
SIGNATURE i
0 l
DATE YES/
/
ENTERED ON "AS"
// /
/
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NRC-SECY FORM MAY, 1987
L,. M.. '
c
/7 A b.
e#p* ** Coq'c, POLICY ISSUE octeeer s. :ge7 (Notation Vote) secy-n-un M:
The Comissioners From:
Victor Stello, Jr.
Executive Director for Operations
Subject:
DISTRIBUTION OF RADIDACTIVE GEMS IRRADIATED IN REACTORS TO UNLICENSED PERSONS (FOLLOW UP TO SECY-87-186)
Durpose:
To answer the Comission's cuestions raised in response to SECY-87-186, ano to recuest Comission approval of staff recommendations regarcing the racioactive gemstone issue.
Category:
This paper covers a minor policy issue regarding application and enforcement of NRC regulations.
However, it relates to two mehr policy issues: d regulation of ra,g minimis quantities of radioactive material and cioactive consumer products.
Issue:
What regulatory position should NRC take with retpect to radioactive gemstones?
Background:
In SECY-87-186, dated July 28, 1987, the staff informed the Comission of its plans to stop distribution of r.evtron-irradiated gems in the U.S. from both U.S. and fore!gn reactors.
The Commission did not approve the staff's plans, ano the Staff Requirements Memorandum dated August 25, 1987 requested a more comprehensive paper.
This paper provides a more comprehensive analysis of the gemstone issue. Additional discuss 1cn of specific ouestions and concerns raised by the Comissioners is provided in Enclosure 1.
Additional infomation recently received from the American Gem Trade Association on the gemstone industry is provided in Enclosure 2.
The radioactive gemstone issue was not raised internally by the staff.
It was raised by reactor licensees and others. Scme were interested in entering the business; others questioned whether NRC had authorized distribution of radioactive gemstones. On the surface, the issue appears to be trivial, but it has escalated into a significant regulatory dilema. The issue relates to CONTACT:
John Hickey, NMSS 42-74248 l
s GOh )11 dA A R A -
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The Connissioners 2
several difficult regulatory areas, including,dj, minimis quantities, " frivolous" consumer products, imports from forti-i countries, and economics. Because a multi-million dollar industry is involved, several interested reactor licensees an~
l other parties have complained to the staff of unfair and ince-
$1 stent regulation, and insist on an expeditious resolution.
i The staff has verified that two reactor licensees are irradiating l
topaz. The University of Missouri is distributing the gems in.
the U.S., and the University of Virginia is exporting the gems.
l The Uriiversity of Missouri recently submitted a paper directly to the Commission explaining its position in favor of continued distribution; the University also recently applied for a-distribution license. The staff has also-received numerous reports of extensive imports of radioactive topaz from foreign suppliers, and reports of limited topaz irradiation in the past by other U.S. research reactors. We also have two applicants for distribution licenses, GA Technologies and Nuclear Theory and Technologies. Officials from these two companies complain that they are being economically penalized for complying with NRC requirements by requestihg proper authorization prior to i
, beginning distribution.
In attempting to resolve this situation, the staff has weiched the uncertainties in health risk and our strict policy agalnst the use of even small quantities of radioactive material in jewelry, against economic considerations, apparent inconsistencies in policies among different countries, and the lackofjgminimisregulations. The staff also recognizes that i
development of a comprehensive jg minimis policy, revised i
consumer product policy, and appropriate rule changes cannot be accomplished in a short time. In the meantime, the staff seeks an expeditious solution to the complaint that licensees are being economically penalized for complying with.NRC i
l regulations.
The staff has identified three options for addressing)the l
' Discussion:
gemstone issue.' They are:
(1) stop distribution; (2 suspend L
distribution while developing appropriate rules governing distributions and (3) allow interim distribution by issuing I
licenses pursuant to 10 CFR 532.11, with an exemption from that portion of $32.11(c) which prohibits application to a human being, while developing more appropriate rules governing distribution. The " pros and " cons" for each option are L
identified below. The second and third options each contain two identical subset options for how to proceed with rulemaking.
l
_ y a
The Comissioners 3
l f
The subset options for rulemaking are to develop (a) a specific l
rule governing exempt distribution of irradiated gemstones as l
4 consumer product, or (b) a Comission policy which establishes a generally applicable 3,minimis dose which would provide a basis for developing a spectrum of rules governing its application, 1
including irradiated gemstones.
l t
Developing a specific " consumer product" type of rule for i
irradiated gemstones would be the more straightforward and less time-consuming way to proceed. However, it would not provide a i
basis for handling other similar proposals which the Commission is likely to receive.
The suboption for a policy statement concerning a generally applicable dg minimis dose followed by implementing rules was derived from several restrictive considerations. cirst, a rule on gg minimis dose alone rather than a policy statement followed by specific implementing rules would be difficult to administer-and could lead to compliance problems for reasons which are described in Enclosure 1. Second, a policy statement alone.
l without being followed by implementing rules, would not accomplish the goal since there are overriding prohibitions in current rules which would prevent its application, including the prohibition contained in 10 CFR 532.11(c). Thus, the staff suggests a policy statement followed by specific implementin option for pursuing the gg, minimis issue. g rules as the best It is similar to the procedure followed for developing exemptions of certain low-level C
waste streams (See SECY-86-204 and 86-304). This suboption for rulemaking has the advantage of addressing a broad spectrum o'f potential applications for a generally applicable gg minimis dose.
It has the disadvantages of being more time-consuming and resource-intensive than resolving the gemstone issue alone, l
Also, a policy which establishes g generally applicable gg minimis dose is likely to be controversial if the dose is to De sufficiently high to have much utility.
l Alternatives:
1.
Stop distribution of neutron-irradiated gemstones (deny l
pending license applications and take enforcement action to stop unauthorized distribution as proposed in SECY 87-186).
Pro:*
o Maintains current Conunission policy and international guidelines on unjustified use of j
radioisotopes in consumer products.
o Provides a clear, unambiguous basis for dealing with similar proposals by making the decision turn on the issue of justification of dose no matter how small, rather than on the level of dose.
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o Enforcement is relatively straightforward because identification of unauthorized distribution is based on color of topaz rather than radioisotope concentration.
Q,n,:
o Imposes economic hardship on an established n
industry by prohibiting a practice which appears to have acceptably sma.1 radiological consequences.
o Denies the public a product it appears 'to want.
2.
Suspend action on present license applications and stop unauthorized distribution while:
(a) developing a rule specifically related to exempt distribution of irradiated gemstones, or (b) developing a policy statement for a generally applicable gorgemstones. minis dose followed by a specific implemen
,P,r2.:
o Provides for orderly development of appropriate rules by holding the line -
on distribution until radio'oq1 cal and public policy issues are reso'ved thorough the administrative process.
gn,:
o imposes an economic hardship and denies public access to a desirable product in a manner similar to Alternative 1 above.
o' Puts the NRC in an ambiguous position with
- respect to the future licensability of irradiated gemstones.
o Opens the door for similar proposals of questionable justification where decisions would turn on level of dose rather than justification for dose no matter how small.
3.
Issue' interim licenses for exempt distribution of irradiated gemstones pursuant to 10 CFR 132.11, with an exemption from that portion of $32.11(c) which prohibits application of products to a human being, while:
(a) developing a more appropriate rule specifically related to exempt distribution of irradiated gemstones, or f
I L
The Commissioners 5
(b) developing a policy statement for a generally applicable di minimis dose followed by a specific l
implementing rule for gemstones.
Pro:
o Circumvents the economic hardship issue for a product which is believet' to have an acceptably small radiological hazard.
Qn:
o Pemits the continuation of a practice l
n where the radiological risk and environmental impact is not fully assessed.
o implies that the Connission is prejudging l.
the acceptability of the practice ahead of
.I the analytical and deliberative process of rulemaking.
o Opens the door for similar proposals of 1
questionable justification where decisions turn on level of dose rather than justification of dose no matter how small.
o Difficult to enforce. requirements for distribution because deteminations would be based on radioisotope.
i concentration of topar rather than j
color.
In coordinating this paper with the appropriate NRC offices, no strong consensus emerged favoring Alternative 2 over Alternative 3. Alternative 1 did not receive significant support.
The argument in favor of Alternative 2 relates to the significant policy issues involved and the precedents the NRC's action will set regarding public exposure through radioactivity introdu' ed c
into consumer products. Alternative 2 would pemit orderly development of rulemaking through appropriate analysis and puolic l
participation in the administrative process, while enforcing i
existing rules which were established through the same process.
l As noted in this paper, the staff is also concerned about -
establishing adequate methods of regulatory control in the interim until appropriate procedures are fully explored and developed, i
Arguments in favor of Alternative 3 relate to concern that the long-standing policy against radioactive adornments does not address situations where radioactivity levels are so low as to be difficult to measure and that the potential health risk would appear to be very low. Therefore, the less disruptive approach would be to allow an established, multi-million dollar industry to continue operations while we review our policy and l-regulations in view of what appears to be a low risk.
j 1
l
The Comissioners 6
The staff believes that the fundamental policy decision to be made in choosing Alternative 2 or Alternative 3 is whether or not the Commission is prepared at this stage to signal a departure from its present policy which clearly identifies as unacceptable certain types of consumer products containing radioisotopes widely available to the public.
Recomendation:
That the Comission:
I 1.
Aporove Alternative 2 to stop current distribution of f
radfoactive gems, while developing a generic g minimis policy statement and implementing regulations. The staff further recommends that if Alternative 2 is selected, option 2(b) should be followedt i.e., a policy statement on a generally applicable g minimis level of dose, followed by specific implementing rules. Although more time.
consuming and resource intensive, this would provide a firm basis for dealing with additional proposals of a similar na ture.
2.
Not that, if Alternative 2 is selected the staff would in orm current applicants, interested licensees, and the jewelry industry of the decision to proceed with rulemaking and take action to stop unauthorized distribution in the interim.
3.
Note that, if the Comission selects Alternative 3, there remain technical issues to be resolved before licenses could be issued which the staff has not yet pursued; e.g.,
proposals to distribute gemstones with radioisotope concentrations above those pemitted by 10 CFR i 30.14, qualitycontrol,etc.(SeeEnclosure3.)
Mtt that, if the Comission selects' Alternative 3, the 4.
i staff anticipates that, in addition to the three current applicants, other reactor licensees and importers will seek authorization to distribute irradiated gems.
hc < 4f a
V Victor Stello, Jr.
Executive Director for Operations
Enclosures:
1.
Staff Response to Comissioners' Questions 2.
Data on Irradiated Gem Industry 3.
Technical Issues Associated with Distribution of Radioactive Gems
[,
}
1 l
7 Commissioners' comments or consent should be provided directly to the Office of the Secretary by c.o.b. Thursday, October 22, 1987.
j Commission Staff office comments, if any, should he submitted to the Commissioners NLT Thursday, October 15, 1987, with an j
information copy to the Office of the Secretary.
If the paper.
i i
is of such a nature that it requires additional time for analytical review and comment, the Commissioners and the Secretariat should be apprised of when comments may be expected.
DISTRIBUTION:
Commissioners l
GPA t
REGIONAL OFFICES 1
I 4
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ENCLOSURE 1.
{
i 7
STAFF RESPONSE TO COMMISSIONER'S QUESTIONS ON SECY-87-186 i
s<
- A.
Chairman Zech's Questions i
OVESTION 1.-
What are the public health and safety risks that these 7
gemstones present?
- ANSWER, V
l The risk to the individual user is believed to be very smil, assuming that the irradiated gems are held for decay and carefully monitored by:the reactor operators prior to release to the public. Although data are sparse and subject' to considerable uncertainty, measurements by the staff indicate surface dose rates of not more than 100 mrem per year based on a few samples. Assuming that:the actual time an individual would wear an irradiated gemstone is.
y substantially'less than full time throughout the year, the. dose to a small area L
ci the s' kin would be considerably less than 100 mrom per year. The dose would
)
be reduced-during each subsequent year due to radioactive decay. Also, the 1
effective whole body dose equivalent for such exposure would be much less than the dose to a small portion of the skin or organ ' irradiated. (See also SECY-87-186, 1.)
i(
l Although the risk to the individual users is believed to be small in most cases, there are other considerations which bear on risks which' require much additional l.
information before a comprehensive conclusion can be reached as to health and safety risks.. Radiation levels or radioisotopic content of irradiated gemstones are a function of trace elements in the mineral content which are subject to f -:
1:
l
- e..
y n
OVESTION h (Continued)
- -3 wide variation. The staff has received data from one licensee'on the analyses-of-a total of 53 neutron-irradiated topaz. According to the' licensee some I
of these stones were irradiated at a U.S. facility and others at European facilities.
The principal radionuclides and their respective maximum concentrations are shown in the table below. Each group of stones counted contained at least two i
of the radionuclides-in the table.'
Redionuclide M,axiyJm Concentration (DC1/a)
Sc-46 550 Mn 350 Zr-95 93 Mb-95 200 Ru-103
, 14 Sn-113 90 Sb-124 41 Sb-125 23 t
Cs-134 100 Co-144 160 Ta-182 4000 This raises issues of control because of difficulties associated with counting techniques at low radiation levels. Because of the length of time involved, in many cases batches of gemstones, rather than individual stones, are counted
e L
OVEST10N 10 -
(Continued) '
4
,for control; purposes.
It.is not clear that ' individual stones, with relatively F
high dose rates (e.g.,10-100 times a given limit ), would be identified and l
withheld from release to the public using batch counting techniques.
'In some instances, unfinished gemstones may be irradiated rather than finished products.
In-these cases, there is an additional unevaluated risk to workers who, while cutting, grinding, or polishing irradiated gemstones, may inhale'
'i t
or ingest particulates. The staff presently has no information which would enable it to reach a definitive conclusion that there is no significant health risk associated with these activities.
However, the staff might address-this issue in the near term by allowing irradiation and distribution of finished gems only.-
In addition to the risk to the individual who wears gemstones, evaluation of population risk, as might be established through collective dose assessment, would.be useful. While neutron irradiation of gemstones is apparently wide -
spread, the staff has no definitive information which would enable it to make a collective dose assessment.
It would be necessary to know distribution patterns of use and typical dose ranges to undertake a collective dose assessment.
In sunmary, while the staff believes that the risk to the individual owners of properly controlled gemstones is very small, the total risk is uncertain because of lack of infonnation. Additional infonnation collection would require a significant investment in resources and time.
L OVESTION 2.
What is involved in establishing d, minimis levels of gemstones?
3 ANSWER.
The first issue in establishing a de minimis level for gemstones would involve a review of our application of the fundamental radiation protection principle.
that no prac'tice involving radiation exposure should be authorized unless there is a positive net benefit. The review would encompass numerous policies and regulations both inside and cutside NRC, including the international comunity. The 1965 Conunission Policy Statement on the use of rat'ioisotopes in consumer products, takes the position that use of radioactive material in adornments, such as jewelry, is of marginal benefit and unjustified..This position is also reflected in international guidelines on consumer products-containing radioisotopes adopted by the International Atomic Energy Agency (IAEA), the Nuclear Energy Agency (NEA), and the World Health Organization.
(WHO).
(Ref. Section 4.2.3. of "A Guide for Controlling Consumer Products Containing. Radioactive Substances," revised in-1985 by the NEA of the-Organisation for Economic Co-operation and Development.) The rule (10 CFR Section 32.11) under which persons have applied for exempt distribution of irradiated gemstones encompasses this policy position by specifically prohibiting the transfer of byproduct material to exempt persons for purposes of "... application to a human being." Note that the Conunission took action in 1983 by amending 10 CFR Part 40 to prohibit the use of uranium frit in eloisonne jewelry (48 FR 33697, July 25,1983). Also, in 1986 the Commission
~
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LOVESTf0N 2.
. (Continued)'.
denied (without prejudice) a Department of Energy petition, which requested an i
exemption from NRC regulations to allow recycle of smelted alloys containing.
.technicium-99 and enriched uranium (51 FR 8842, March 14, 1986). The Comissir a noted the need to work with the Environmental Protection Agency on an integre:'d federal policy on contaminated materials, and that 3700 public coments were received on the proposal, most of which opposed the introduction of radioactive material into consumer products.
If a fundamental policy decision were made to allow the use'of jewelry containing1 byproduct material, the remairder of the problem of establishing regulations for distribution of gemstones at some de minimis level is largely technical. The i
models-used to establish the exempt concentrations in 10 CFR 30.14 and 30.70 are not definitive, because the concentrations were conservatively based on dose resulting from inhala' tion or ingestion and were intended to keep doses at a small fraction of 500 mrem per year. A maximum. external radiation level is more appropriate for a de minimis gemstone rule. To establish an.
appropriate radiation level, the staff would need to collect'infomation which would enable it to assess risk to the individual user, gemstone workers, collective population risk, and practical methods of quality control This last element would include a substantial effort to identify reliable counting techn'iques and standa'rds, to measure radiation levels in irradiated stones.
Once' the range of risks and their interrelationships are understood, then it should be possible to develop an appropriate maximum radioactivity limit for gemstones.
c w..
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. 1
)
QUESTION 3.
What is the impact on NRC of proceeding to establish'a de_
minimis regulation?
Development of such a rule will be a complex, time-consuming process. Many attempts have been made over the past three decades.to develop generic-ge,minimisdoselimits. These have failed mainly because of practical.
problems with implementation. An attempt to' develop a policy or rule on a generally applicable dg, minimis dose limit would likely be as resource-intensive as it was for the Safety Goals Policy and success would not
-be assured. Earlier attempts at establishing a dose limit did not have
-]
broad Agency support and were abandoned because of the level of difficulty in
-1 treating many of the policy issues and practical problems associated with the endeavor. With a broad agency comitment it might be feasible to establish '
such a policy or rule.
H
'1 The acceptable level of risk represented by a dg, minimis dose limit, while 1
controversial, would not be too difficult in itself to establish since there are precedents. The preponderance of thought on an appropriate level of risk l
is in the range of 10-8 to 10-6 annual risk.of radiation-induced cancer
-leading to death or a dose of 0.1 mrem /yr to 10 mrem /yr. The National Council on Radiation Protection and Measurements (NCRP) recently issued Report No. 91,
" Recommendations on Limits for Exposure to Ionizing Radiation," which recomends 4
a negligible individual risk limit (NIRL) of 10 per year or 1 millirem per year. The rationale for this NIRL value appears to be a synthesis of many papers-on this subject. More difficult to address are the issues relating to the practical application of a de minimis policy or rule. For example:
QUESTSON 3.
(Continued) 7'-
1.
How is the source or practice which is permitted to deliver a d_e minimis e
dose' defined?'In the case of gemstones, for example, should the dose limit apply to a single gemstone or multiple gemstones worn on a person?
If it is the former and there is a desire to limit total risk to the individual, then it can drive the de minimis limit sufficiently low to be of little practical value.
If it is the latter, then control.must be f
exercised at the jeweler level where the dose from combinations 'of gemstones can be evaluated rather than at the reactor doing the irradiation where control is placed on individual gemstones. This is a rather simple.
t example. The problem of defining a source or practice for other activities-such as waste disposal becomes much more difficult.
2.
Wh'o determines-that a source or practice is within the g minimis dose limit? The dose to an individual will be a function of dose rate, occupancy times, and pathwayi of exposure. Depending on' the assumptions, made, dose estimates can often vary by a facter of 100. Complex calculations and many assumptions are often needed to establish the relationship of dose to dose rate or to radioisotope concentration of the source.
If such a detennination is the responsibility of the persons
. causing the dose, how does a regulatory agency detemine that its policy or rule is being met? In light of this uncertainty, it would necessarily be the responsibility of the regulatory agency to assess and control dose. This would most likely be accomplished through a series of rules dealing with specific practices. This is the course anticipated in the-Commission's Policy Statement on radioactive waste (51 FR 30839, August 29,1986). It is also similar to what has been done in the past for consumer product exemptions.
c.c 0
OVEST10N 30 (Continued),
3..
Should caps be placed on one or more of the following: individual risk from multiple sources and practices, collective population dose resulting from multiple sources and practices, or-the number and type of.
sources and practices approved? If so.- how would the caps be assessed and regulated?
l Unless these and similar matters are addressed in a policy or rule which establishesagenerallyapplicablejeminimisdose,wearelikelytoexperience many radiation control problems through lack of knowledge in its proper application or through abuses. Although NCRP Report No. 91 suggests that any single person could be. subject to as many as 10 " negligible individual risk limit" sources per year, and still be within an acceptable risk level of 10-6, it does not address, nor should it necessarily address, the difficult regulatoryproblemsassociatedwithimplementinga.'jgminimisdosevalue. An attempt is underway'at the IAEA and NEA to come to grips with some of these-problems such as definition of a source or practice for application of a jg minimis dose. These are not insunnountable problems, but they would require a dedicated and resource-intensive effort to analyze and resolve.
r:
l-p
f 9
QUESTION'4.1 Who is in violation of NRC regulations?'
ANSWER.
I Anyonewho distributes irradiated gemstones containing byproduct material to members of the public (or irradiates gems with inter.t to distribute) and w
does not have'an NRC license authorizing this distribution is in violation of NRC regulations (10 CFR 30.14(d)]..(Nolicenseshavebeengrantedauthorizing i
i.
such distribution.)
'l Under strict interpretation of the regulations, the University of Missouri is in violation of 10 CFR,30.14(d), even though after a 1986 inspection by Region III, distribution was restricted to those gems which the licensee says
=
contain radioactivity statistically indistinguishable from background.
The staff has received reports that a few other U.S. research reactors have.
irradiated gems in-the past. The University of Virginia is currently 1rradiating gems for export only. There are also numerous reports'of imports
-1 of irradiated gems. The staff has delayed coomitting additional inspection resources to follow up on these reports pending additional guittance from Headquarters.
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- 0 VEST 10N 5.
Should we take enforcement action?
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J ANSWER.
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.j SECY-87-186 recomended that we should take enforcement action (i.e.,
appropriate action to stop the unauthorized distribution of irradiated gemstones).
In developing this recomendation, the staff considered the i
following:
l 1.
A clear violation of an NRC regulation (10 CFR Sections 30.14(b) and(d)]isinvolved, j
2.
The issue was not raised internally by the staff, but rather by i
1 allegations and inquiries from other reactor licensees and. members of the public.
l l
3.
Two organizations who have applied for distribution licenses have complained that they are being economically penalized for complying with NRC requirements. On the other hand, the University of Missouri and foreign suppliers have entered into an unauthorized activity, without obtaining the required license, and derived significant profits from the activity.
4 Various jewelry retailers and others have expressed concern that a radioactive consumer product is on the market which is unlabeled and unauthorized by NRC.
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- 00ESTION 5.-
(Continued)!.!
1 51 Even'if-the staff were to allow restricted distribution of gems, there are practical problems for both the suppliers and NRC in assuring p
compliance. The industry might continue to press NRC for less restrictive procedures, through petitions for rulemaking or requests.
j for exemptions from the regulations.
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6.
Even in cases where the health hazard associated with a violation appears to be small, the agency should require compliance in order to maintain integrity and consistency-in its regulatory program.
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particularly where significant economic benefit is gained from the L
l-violation.
7.
Although the staff believes that foreign reactors are in most cases holding gems for decay to low radiation levels, there is currently no _ assurance that gems are not and will not be shipped to the U.S.
containing much higher radiation levels.
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- 12 o OVEST10N 6.-
Do the regulations make sense and are they enforceable?-
L ANSWER:
L As-recognized by the Comission and the staff, the regulations do not "make o
sense"-in that they do not reflect a comprehensive policy on the de minimis
~
issue. However, with respect to the gemstone issue, the current Policy Statement and rules governing byproduct material in consumer products make sense and are enforceable. They are based on the sound regulatory principle that members of the public should not be deliberately exposed to even small doses of radiation without a compensating benefit. The.1965 Policy Statement which identifies the use of byproduct material in toys, novelties, and l
adornments (such as jewelry) as a frivolous and unjustified use is unambiguous..
Rules authorizing exempt distribution of consumer products reflect this policy; they are also enforceable. Domestic irradiation of gemstones can be stopped i-at the source. Comercial import of irradiated topaz can likely be controlled because it can be identified by color. Therefore, it would not be necessary, l
as a routine matter. to naasure for radioactivity to control import. Very little, if any, NRC resources would be needed to assist Customs. Gemstones brought.into the country by private individuals for personal use would not be controlled, but this is a minor part of the problem.
L Note that changing the Policy Statement and regulations which prohibit use of byproduct material in toys, novelties, and adornments would raise policy questions about justification of doses associated with such products, and l~
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OVESTION 6.;
(Continued) '
would not necessarily make 'the regulations more enforceable.. Based on past.
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-experience, we could expect a number of proposals for use of byproduct material in toys, novelties, and jewelry, in addition to gemstones. Control of gemstones and other products.would require extensive quality assurance controls and-
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' monitoring of domestic suppliers.
In the case of imported topaz,-Customs would need to exercise control through measurement of radiation levels rather.
.i simply identifying the product by color. Radiation measurements at:yery low dose rates-require sophisticated and time-consuming techniques which are not 1
practical to' undertake on a large scale. Customs would undoubtedly need s
substantial NRC assistance to' implement an effective control program.
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QUESTION 7.
How is this matter treated in other countries?
- ANSWER, The staff is aware that gemstones are being irradiated in several countries in l
- Europe and elsewhere.
In West Germany, one reactor has been specifically l
licensed to release ~ irradiated gems below 2 nanocuries~per gram. Through informal connunication with Richard E. Cunningham, we understand tha,t.a reactor in Switzerland is irradiating about 10 kilograms of topaz per month with release limits set at less that 5 nanocuries per gram. However,'we do
- not know the full extent to which such practices have been authorized nor the
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types of controls applied in all countries. Because of the international character of the problem of effective control, Mr.' Cunningham raised the issue in the March 1987 meeting of the NEA's Connittee on Radiation Protection and Public Health. The meeting was also attended by representatives from the,
International Atomic' Energy Agency (IAEA), the International Connission on Radiological Protection (ICRP), the World Health Organization (WHO), and the Connission of the European Connunities (CEC).
Mr. Cunningham posed three questions for the Connittee:
1.
Should irradiated gems containing low-level radioactivity be excluded from the consumer products prohibition under Section 4.2.3 of the 1985 NEA guide on consumer products, which cites articles of personal adornment as an example of an unjustified use?
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OVESTION 7..
(Continued) !
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2.
If irradiated gems are acceptable as a consumer product, should appropriate.
international guidance be developed for assurirt that gems are held for decay and properly monitored prior to distrEution?
e 3.
Since countries outside NEA membership are involved, is NEA the appropriate organization to address this problem? Should the matter be referred to IAEA7 t
From the discussions which followed, it appeared to Mr. Cunningham that-few, if any, Conunittee members knew in detail the extent of gemstone distribution or controls exercised in their respective countries,.
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There was divided opinion as to whether an exception should be made to the.
international guidelines which cite articles for personal adornment as an example of an unjustified use of radioactive material. However, opinions on this point were very prel'iminary because Committee members expressed the need for further information before reaching a final conclusion. Certain Conunittee members said that they would look into practices being conducted in their countries.
There seemed to be a consensus that, as a minimum, international guidelines j
are needed which assure that the radioactivity content of (or the dose from) irradiated gemstones released for public use is maintained below an established standard. Follow-up is planned through NEA and IAEA.
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OVESTION'8.
How is this viewed by NRC and Agreement States licensees?
ANSWER..
There is a clear comercial interest and market for irradiated gemstones, assuming the activity is approved by NRC. While the number of licensees engaged in this activity would likely be small, it is of high interest to those involved as well as to segments of the jewelry industry. Two pending applications for exempt distribution of irradiated gemstones are from-organizations located in California, an Agreement State.
(TheUniversity 1
of Missouri-also submitted an application on August 20,1987.) Under the provisions of 10 CFR 150.15(a)(6), the NRC retains jurisdiction o<or reactors and all licensing of exempt distribution of byproduct material-in consumer products within Agreement States. Therefore 'there is no distinction between requirements for licensees located in Agreement States and those in non-Agreement States.
- l Industrial sources have reported to NRC that gems are also irradiated.in accelerators, which are regulated by the States,- not NRC'.
Infonnation
- available to the staff indicates that the potential for inducing radioactivity in gems by accelerators is much less than for reactors.
In any event, the
- l staff anticipates that most States will look to NRC for policy guidance regarding radioactive gems.
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. Comissioner Bernthal's-Coments i'
COMMENTS.
Staff should also strengthen its " Radiological-Assessment," should' 5
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evaluate the feasibility and/or_ impact of storage for decay and I
should provide, for purposes of comparison, a discussion of the 1
l range of natural radioactivity in precious and semi-precious gemstones routinely.used as " adornments."
ANSWER.
Additional-information on the health risks associated with the radioactive
, gems is provided in respon.se to Chainnan Zech's. Question No.1.
. The staff has considered the feasibility ~of storage and decay, and in fact the gems currently being distributed are held for decay prior to release.
However, because = the principal radionuclides _ range in half-life from 84 to.
3'03 days, the radioactivity does not decay away completely, and is still measur'able after several-years. Therefore, storage for decay -is only feasible -
if a limit is established below which gems may be released. Note that the release limits proposed by industrial sources,, ranging from 0.6 to 10-nanocuries per gram, are above the exempt concentrations specified in 10 CFR Section 30.70.
In other words, the industry is proposing to release licensable, measurable quantities of radioactive material to unlicensed Consumers.
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1 It is difficult:to summarize-the quantities of natural radioactivity in minerals; because of the'large variation. The range.is from a few picocuries to several thousand picoeuries _per gram, or even higher if a substantial percentage of uranium is present. Certainly the natural' radioactivity in topaz is much~ less <
- than:the reactor-induced radioactivity (thousands of picoeuries per gram), On-the other-hand. blue topaz. is less radioactive than some uranium cloisonne jewelry.,
Therefore, it can be stated that the hazard from blue topaz is in some cases '
less than the hazards from certain other naturally occurring radiation sources.-
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Connissioner Roberts' Coments r
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COMMENTS.
I would like to know:
- 1) the details of the enforcement action
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halting the import of radioactive topaz gems from Brazil, 2). the -
current position of the Nuclear Energy Agency in this matter and
- 3) the NRC resources allocated to cooperate with the U.S. Customs Service.
ANSWER.
In October 1981, Region I was informed that radiation had been detected from blue, topaz gems believed to have been imported from Brazil.
Region I obtained samples of the gems and surveyed them, finding about 0.2 mrom per hour per gem and 12 mrem per hour on a bag of 100 soms. Gems received from two jewelers were analyzed and found to contain scandium-46 and tantalum-182 (Ta-182), with-p a maximum concentration of about 3 nanocuries of Ta-182 per gram.
NRC sought more.information on this matter from the Braz'ilian government.
In several cables beginning,in December 1981, the United States (NRC/IP through I
L the U.S. State Department) infonned Brazil of its findings and asked for further information including whether gems were being irradiated with neutrons 1
in Brazil..Later, CNEN (Brazil's equivalent to NRC) confinned that gems were being irradiated at the IPEN Research Facility in.Sao Paulo. CNEN suspended
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-i IPEN's neutron irradiation of gems and ordered IPEN to provide additional infonnation on the project to CNEN.
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This matter was handled through diplomatic channels and the United States relied on the Brazilian government's assurance that it had put a stop to the p
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. practice. NRC did not take-any formal enforcement action against any person.
or organization that had imported radioactive blue topaz from Brazil. The use of.the phrase " enforcement action" in connection with Brazilian blue topaz was somewhat misleading since halting the import of the gemstones in this case was not similar to the type of action which would be followed in a domestic case, r
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' The position of'the Nuclear Energy Agency is discussed'in the response to Chairman Zech's Question No. 7.
The staff has not allocated special resources to cooperate with the.U.S.
Customs Service.
It is anticipated that the gemstone problem can be addressed with existing staff resources assigned to international programs.
-inspection, and enforcement.
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, l Commissioner Carr's Connents 0.
COM9ENTS.
.The staff.should consider guidance recently issued by NCRP on this matter. Also... advise the Commission-as to how NRC activities on.
limits for unrestricted use, de minimis, and below regulatory concern are related.
' ANSWER.
The recent.NCRP guidance is discussed in the answer to Chairman Zech's Question No. 3.
d The terms dg minimis and below regulatory concern (BRC) are often used synonymously.. "De minimis non curat lex," or "the law does not concern itself:
with trivialities," is a definition which expresses the issue for regulatory purposes. NRC subscribes to the linear, non-threshold theory of dose and effect for planning radiation protection and assessing radiation dose consequences. The theory implies that any radiation dose, no matter how small, has some corresponding effect.. However, there is some point at which the, effort to regulate very _ low doses exceeds the benefit derived from such regulation. The term below regulatory concern is employed to recognize that there is, at least in theory, some health-effect associated with a trivial
' dose., but it is so small that it is not worth the effort to regulate.
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3 l Limits for unrestricted use, on the other hand, are quite different in concept-from BRC dose, levels.
Such limits are based on consideration of the overall i
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_reconnended limit for public exposure and the application of ALARA below that i
limit.. Derived dose limits for unrestricted use should be a fraction of the overt.ll public dose limit, so that when combined with other sources of public exposure, the latter will not be exceeded. Derivation of the limits-is also coupled with the ALARA principle which takes into account the technology for dose reduction and the cost of further reduction. Limits for unrestricted use will vary depending on the situation under consideration and will often be l.
greater than.would be the case for a generally applicable BRC limit. Limits for unrestricted use are nomally expressed in tems of radioisotopes concentrations or radiation levels which depend on the type of equipn.ent, ll facility, site, waste stream, etc., under consideration as well as the radio-l nuclides involved, pathways of exposure, occupancy times, and other parameters
.affecting projected dose. Derived limits for unrestricted use are contained
-l in license conditions, guides, and staff technical positions.
In the latter two instances, ~a licensing action is nomally involved before a licensee can take advantage'of the derived limit. A derived limit for unrestricted use as applied to specific cases generally reflects a p.ractical level of dose where l
further regulatory control does not result in significant dose reduction, 1
j Once released for unrestricted use, no further regulatory control is exercised.
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