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16298
Federal Register
/Vol. 67, No. 66/Friday, April 5, 2002/Rules and Regulations
Spring Gem, Sugar Giant, Sugar Lady,Summer Dragon, Summer Lady,Summer Sweet, Summer Zee,Supechfour (Amber Crest), SweetDream, Sweet Gem, Sweet Kay, SweetSeptember, Tra Zee, Vista, White Lady,Zee Lady, or 24
–
SB variety peachesunless:* * * * *
Dated: March 28, 2002.
A.J. Yates,
Administrator, Agricultural Marketing Service.
[FR Doc. 02
–
8140 Filed 4
–
3
–
02; 9:51 am]
BILLING CODE 3410
 –
02
 –
P
NUCLEAR REGULATORYCOMMISSION10 CFR Part 20
RIN 3150
 –
AG25
Revision of the Skin Dose Limit
AGENCY
:
Nuclear RegulatoryCommission.
ACTION
:
Final rule.
SUMMARY
:
The Nuclear RegulatoryCommission (NRC) is amending itsregulations in 10 CFR part 20 to changethe definition and method of calculatingShallow-dose equivalents (SDEs) byspecifying that the assigned SDE must be the dose averaged over the 10 squarecentimeters of skin receiving the highestexposure, rather than 1 squarecentimeter as stated in the existingregulation. A result of this rulemaking isto make the skin dose limit lessrestrictive when small areas of skin areirradiated (i.e. more representative of actual health risks) and to address skinand extremity doses from all sourcegeometries under a single limit. Thischange requires measuring orcalculating SDEs from discreteradioactive particles (DRPs) on or off theskin, from very small areas (<1.0 squarecentimeter) of skin contamination, andfrom any other source of SDE byaveraging the measured or calculateddose over the most highly exposed,contiguous 10 square centimeters forcomparison to the skin dose limit of 50rem (0.5 Sv). The Commission believesthat although the less restrictive limit ondose to small areas of the skin mightpermit more frequent, transient,observable effects such as reddening of the skin, the change neverthelessrepresents a substantial increase inworker protection because reducedmonitoring for DRPs will result inreduced external dose and reduced useof protective clothing will result infewer industrial hazards in theworkplace.
EFFECTIVE DATE
:
 June 4, 2002.
FOR FURTHER INFORMATION CONTACT
:
Alan K. Roecklein, Office of NuclearReactor Regulation, U.S. NuclearRegulatory Commission, Washington,DC 20555
–
0001, telephone (301) 415
–
3883; e-mail
AKR@nrc.gov.
SUPPLEMENTARY INFORMATION
:
I. Background
With the installation of very sensitiveportal monitors in the mid- and late-1980s, many nuclear power plantsdetected contamination of individualsand their clothing by small, usuallymicroscopic, highly radioactive beta or beta-gamma emitting particles havingrelatively high specific activity. Theseparticles, known as
‘‘
discreteradioactive particles
’’
(DRPs) andsometimes
‘‘
hot particles,
’’
mostcommonly contain
60
Co or fissionproducts. DRPs apparently becomeelectrically charged as a result of radioactive decay and, therefore, tend to be fairly mobile. DRP movement in theworkplace is unpredictable and, thus,worker contamination is difficult tocontrol. A unique aspect of DRPs on orvery near the skin is that very smallamounts of tissue can be exposed tolarge, highly nonuniform doses. Theseintense, localized irradiations mayproduce deterministic effects, such asreddening of the skin, transient breaksin the skin or necrosis of small areas of the skin, but the stochastic risk of inducing skin cancer due to a DRPexposure is negligible.In the late-1990s, a materials licenseereported that workers received DRPexposures while manufacturingradiographic sources. In addition to theDRP concern, several events haveoccurred involving contamination of very small areas (<1.0 squarecentimeter) of skin, primarily in thehandling of solutions of highlyconcentrated radiopharmaceuticals.Although these contamination eventsproduce relatively large doses to verysmall areas of skin, they are known toresult in insignificant overall healthdetriments. Nevertheless, under existingprovisions in NRC regulations, severalof these contamination events weredefined as overexposures, and resultedin enforcement actions, with the resultthat workers could not be assigned workin radiation areas for the balance of theyear. These consequences were notcommensurate with the actual healthdetriment.The principal stochastic riskassociated with irradiation of the skin isnon-melanoma skin cancer (that is, basal cell and squamous cell skincancer). The risk of skin cancerfollowing irradiation of the skin byDRPs, or from very small areas of contamination, is not comparable toirradiation of extended areas of the skin because of the very small number of cells involved and the greater potentialfor high local beta particle dose to killcells rather than cause transformation toa precancerous stage. In Report No. 106,
‘‘
Limit for Exposure to
‘‘
Hot Particles
’’
on the Skin
’’
(1989), the Congressionallychartered National Council on RadiationProtection and Measurements (NCRP)conservatively estimated the risk of skincancer following a DRP dose of 50 rem(0.5 Sv) to an area of 2 mm
2
to be 7
×
10
¥
7
Gy
¥
1
(7
×
10
¥
9
rad
¥
1
), and therisk of skin cancer mortality to be about1 x 10
¥
9
Gy
¥
1
(1
×
10
¥
11
rad
¥
1
).Because the risk of stochastic effects(i.e., cancer) from gamma and betaradiation from DRPs has been shown to be negligible for DRP exposures to theskin, induction of skin cancer is of lessconcern than the potential fordeterministic effects.In 1991, the NRC revised Title 10, part20 of the Code of Federal Regulationsand its occupational dose limit for theskin of the whole body to 50 rem (0.5Sv) SDE per year to preventdeterministic effects that might resultfrom a lifetime exposure at the doselimit (56 FR 23360; May 21, 1991). Thisdose limit for the skin is specified in 10CFR 20.1201(a)(2)(ii), and is intended toprevent damage to areas of the skin thatare large relative to areas exposed byDRPs on the skin, and that couldcompromise skin function orappearance. The NRC noted in thatrulemaking that certain issues
‘‘
are being resolved in other rulemakingproceedings because of either theirscope, complexity, or timing.
’’
One of the issues that was listed concernedlimits and calculational procedures fordealing with the DRP issue. It wasrecognized that the current skin doselimit was overly conservative for DRPdoses and SDEs to very small areas of the skin. The final rule stated that therewould be a rulemaking to set limits forskin irradiation by DRPs. Thisamendment to 10 CFR part 20 responds,in part, to that commitment.The existing part 20 skin dose limit of 50 rem (0.5 Sv) averaged over 1 squarecentimeter was intended to apply to arelatively uniform dose to a larger areaof skin than that usually exposed byDRPs with the objective of preventingdeterministic damage to the skin.Because the NCRP considered this limitto be overly conservative for DRPs on orvery near the skin, the NRC announcedan interim enforcement discretion
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16299
Federal Register
/Vol. 67, No. 66/Friday, April 5, 2002/Rules and Regulations
policy in Information Notice (IN) 90
–
48,
‘‘
Enforcement Policy for Hot ParticleExposures
’’
(55 FR 31113; July 31,1990). That policy addressed reportingand mitigation if a DRP dose exceededthe existing limit of 50 rem (0.5 Sv) over1 square centimeter, and stated that theNRC would take enforcement action foroverexposures if the DRP beta emissionexceeded 75
µ
Ci-hrs (approximately300
–
500 rads). To avoid DRP dosesgreater than 50 rem (0.5 Sv) and theresulting reporting requirement,licensees monitor workers for DRPcontamination frequently during thework shift. This results in additionalexternal dose either to the workers, whoincur additional exposure time inexiting and reentering the restrictedarea, or to the radiation protection staff,who must enter the restricted area toperform the monitoring.In 1988, the NRC contracted withBrookhaven National Laboratory (BNL)to study the health effects of DRPs onthe skin and initiated a contract withthe NCRP to develop guidance oncontrolling DRP doses. In NUREG/CR
–
6531,
‘‘
Effects of Radioactive HotParticles on Pig Skin
’’
(June 1997), BNLprovided data on the probability thatirradiation of the skin by DRPs incontact with or near the skin wouldproduce breaks in the skin anddemonstrated that these effects would be very unlikely to pose any serioushealth problems to workers. The BNLwork examined the nonuniform, highlyconcentrated dose to 1 squarecentimeter from DRPs in contact with ornear the skin, and not the dose thatwould be delivered to the adjacent skintissue. This BNL data was supported byother reported studies and similarexperiments performed by the ElectricPower Research Institute (EPRI) asreported in EPRI TR
–
104781,
‘‘
SkinInjuries From Discrete RadioactiveParticles
’’
(1994). Consequently, inReport No. 130,
‘‘
Biological Effects andExposure Limits for
‘‘
Hot Particles
’’
 (1999), the NCRP recommended a dose-limiting guideline for DRPs of 50 rads(0.5 Gy) averaged over the most highlyexposed 10 square centimeters.In October 1998, the NRC staff submitted a rulemaking plan (SECY
–
98
–
245) entitled
‘‘
Protection AgainstDiscrete Radioactive Particle (DRP)Exposures (10 CFR Part 20).
’’
In thatplan the NRC staff proposedestablishing a constraint of 300 rads (3Gy) over 1 square centimeter as aprogram design guideline or actionlevel, and a limit of 1000 rads (10 Gy)over 1 square centimeter for DRPs on ornear the skin. The existing skin doselimit would have been retained for allother skin doses. The intent of thatproposed amendment was to reduce theadditional external dose incurred byworkers in monitoring for DRPcontamination during work shifts and toreduce unnecessary regulatory burden by adopting more realistic thresholds forDRP dose control and reportingrequirements. In a staff requirementsmemorandum (SRM) dated December23, 1998, the Commission directed theNRC staff to proceed with rulemaking asproposed, but to use 500 rads (5 Gy) per1 square centimeter as the dose limit to be consistent with the recommendationsin NCRP Report No. 106.In March 1999, several industryexperts who had reviewed the publiclyavailable rulemaking plan and SRMsuggested that the planned action wouldnot accomplish one of the intendedobjectives, that is, to reduce thefrequency of worker monitoring. Theindustry concern argued against use of a DRP dose constraint with a 500-rem(5.0-Sv) limit, and supported use of theNCRP-recommended skin dose limitthat is adopted in this rule. Specifically,the industry concern stated that, of allDRP events, fewer than 10 percent areon, or near enough to, the skin for theproposed constraint and limit to apply.Most DRP events (> 90 percent) are onclothing or hair, or are far enough awayfrom the skin (and most likely moving)so that the dose to the skin is moreuniform and spread over a larger area.In that case, the existing 50-rem (0.5-Sv)skin dose limit would be applicable.This information suggested that areduction in DRP monitoring frequency,and the associated external dose, couldnot be realized for most DRP exposures, because of the need to preventexceeding the existing skin dose limit.Because the licensee may not know inadvance whether the DRP is on the skinor moving, the licensee would need toassume that the existing skin dose limitwas applicable.The justification for proposing aconstraint, or action level, of 300 rads(3.0 Gy) over 1 square centimeter was inlarge part to reduce the additionalexternal dose incurred by plant staff from frequent monitoring to avoidhaving to report a DRP dose thatexceeded the existing 50-rem (0.5-Sv)skin dose limit. If more than 90 percentof DRPs are off the skin and irradiate arelatively large area, the existing skindose limit would be controlling and theconstraint would only rarely be used.The NRC staff concluded that little relief from monitoring dose would result fromimplementing the constraint and the500-rad (5-Gy) limit. In a memorandumto the Commission dated October 27,1999 (COMSECY
–
00
–
0009), the NRCstaff explained why the constraint witha limit of 500 rads (5 Gy) would notaccomplish this intended objective, andrecommended further work to identifyan effective regulatory approach. In anSRM dated March 16, 2000, theCommission directed the NRC staff tocontract with the NCRP to provideadditional technical support on thisissue.In December 1999, the NCRP hadpublished Report No. 130,
‘‘
BiologicalEffects and Exposure Limits for
‘
HotParticles
’
.
’’
In that report the NCRPrecommended that the dose to skin at adepth of 70
µ
m (7 mg/cm
2
) from hotparticles on skin (including the ear),hair, or clothing be limited to no morethan 50 rads (0.5 Gy) averaged over themost highly exposed 10 squarecentimeters of skin.The averaging area of 10 squarecentimeters, recommended by theNCRP, is applicable to both the casewhen a DRP is on the skin or a verysmall area of skin is contaminated, andthe case when a DRP is on clothing andmoving about exposing an area on theorder of 10 square centimeters or more.In the former case, averaging the verylocalized dose over 10 squarecentimeters results in a dose value thatmore appropriately reflects the riskassociated with exposure of a smallarea. In the latter case, averaging arelatively uniform dose to the entire 10square centimeters results in a doselimit that is equivalent to the current 50rem over 1 square centimeter. Thus, thelimit decreases as the exposed skin areaincreases to 10 square centimeters,consistent with the expectation that therisk of an effect increases withincreasing area of skin exposed to agiven dose level. This averaging area isalso consistent with the skin doselimiting system adopted by theDepartment of Energy in 10 CFR part835.In an effort to find the least burdensome regulatory requirement forcontrolling DRP doses, as well as otherskin doses, while maintaining anadequate level of worker protection, theNRC staff requested that the NCRPconsider the advisability of applying itsproposed limit for DRP exposures to allskin dose geometries. In March 2001,the NCRP published Statement No. 9,
‘‘
Extension of the Skin Exposure Limitfor Hot Particles to Other Sources of Skin Irradiation,
’’
which can be foundon the NCRP Website at
www.ncrp.com/ statemnt.html 
. In this statement, theNCRP recommended that the absorbedradiation dose to skin at a depth of 70
µ
m (7 mg/cm
2
) from any source of irradiation be limited to 50 rads (0.5 Gy)averaged over the most highly exposed10 square centimeters of skin.
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16300
Federal Register
/Vol. 67, No. 66/Friday, April 5, 2002/Rules and Regulations
Dr. John Baum, Ph.D., an NRCconsultant, reviewed the health effectsimplications of the NCRPrecommendation. Dr. Baum wrote atechnical paper entitled
‘‘
Analysis of Potential Radiobiological Effects Relatedto a Unified Skin Dose Limit,
’’
that waspublished in the June 2001 issue (pp.537
–
543) of the peer-reviewed journal
Health Physics
. In this paper, Dr. Baumestimated the probabilities and severityof both stochastic and deterministiceffects for a wide range of exposurescenarios based on the research done byBNL and other research facilities, aswell as information found in NCRPReport Nos. 106 and 130. Published datafrom experimental and epidemiologicalstudies, as well as calculations of radial-and depth-dose distributions, show thatskin exposures at the dose limit of 50rem (0.5 Sv) SDE averaged over 10 cm
2
could result in stochastic risks of <6.6
×
10
¥
10
rem
¥
1
and <3.2
×
10
¥
7
rem
¥
1
for fatal and nonfatal skin cancersrespectively, confirming that stochasticrisks at the proposed limit are small.Given exposures at the proposed skindose limit, that is, 50 rem (0.5 Sv)averaged over 10 square centimeters, Dr.Baum estimated that the worst-casedeterministic effects are a 5-percentprobability of erythema if all of the dose(500 rem) were delivered to an area of 2.5 square centimeters, and a 50-percentprobability that measurable dermalthinning would be observable if all of the dose were delivered to an area of <0.5 square centimeters. At this dose, noacute cell killing or skin ulceration waspredicted for DRPs 3 or moremillimeters off the skin because thedose is distributed over too large anarea. The worst case probability of producing a barely detectable scab as aresult of acute cell killing was estimatedto be 10 percent for
60
Co or activatedfuel DRPs located about 0.4 mm off theskin. Additional discussion of implications of the health effectsassociated with the proposed unifiedskin dose limit can be found in theregulatory analysis developed for thisrulemaking.The NRC published a proposed rulein the
Federal Register
on July 12, 2001(66 FR 36502). That rule proposedchanging the method of calculatingSDEs to the skin or the extremities byspecifying in 10 CFR 20.1201(c) that theassigned SDE must be the dose averagedover the contiguous 10 squarecentimeters of skin receiving the highestexposure. Shortly after publishing theproposed rule, the NRC monitored adiscussion of the rule that took place ona publicly accessible radiationprotection bulletin board (RADSAFE).Comments were favorable regarding theintent and justification of the rule.However, radiation protectionpractitioners in the field raised severaltechnical questions regardingimplementation guidance. Although thisexchange does not technically constitutepublic comment, the NRC staff hasdecided to note that parallel to thisrulemaking, an effort is underway tocontract for a major revision to theVARSKIN II computer code. Thisrevision is expected to addresscalculations that will accommodate thenew skin dose limit and address thetechnical questions raised in theRADSAFE discussion of the rule.
II. Analysis of Public Comments andStaff Response
The NRC received nine letters of public comment, all supporting theproposed rule. Mallinckrodt, asubsidiary of Tyco Healthcare,commented that it is in favor of theproposed revision of the skin dose limitand agrees with the NCRP
’
srecommendations because the new ruleencompasses SDE from all sources intoone limit. The Council onRadionuclides andRadiopharmaceuticals (CORAR), anassociation of NRC and Agreement Statelicensees that use unsealed sources of radioactive materials, fully supportedthe proposed rule. CORAR stated thatthe new limit would be more protectiveof workers, and more comparable tocurrent annual limits for deep dose andlens of the eye dose than the currentlimit, would establish a skin dose limiton a risk-informed basis, and wouldsimplify the regulations.CORAR requested clarificationregarding the limit on deep-doseequivalent (DDE) to the extremities. Nosuch limit exists. DDE, which
§
20.1201(a)(1) limits to 5 rem (50 mSv)in a year, is defined as applying toexternal whole-body exposure, and thewhole body is defined as excluding theextremities. The SDE limit of 50 rems(0.50 Sv) averaged over 10 squarecentimeters is considered to adequatelyprotect against any associated DDE tothe less-radiosensitive deep tissues of the extremities.CORAR noted that the NRC shouldallow licensees to estimate doses for theactual skin thickness involved, ratherthan a tissue depth of 0.007 cm asrequired. The NRC staff is notconsidering any changes to thisrequirement. For most areas of the bodythe specified depth defines the mostradiosensitive tissue or leads to aconservative dose calculation if thesensitive tissue is deeper. Calculation of SDE at a depth of 0.007 cm isconsidered an important component of an acceptable radiation protectionprogram, and will continue to berequired to demonstrate compliancewith the skin and extremity dose limits.CORAR proposed that the NRCprovide clarification of the limit in theevent that multiple SDEs were deliveredto the same skin area during the year.The NRC staff believes that the annuallimit of 50 rems (0.50 Sv), modified bythe requirement in
§
20.1201(c) that theassigned SDE must be for the
‘‘
***contiguous 10 square centimeters of skin receiving the highest exposure,
’’
makes it clear that multiple exposures tothe same area during the record yearwould be additive for comparison to thelimit. This interpretation is consistentwith the recommendations stated inNCRP Statement No. 9,
‘‘
Extension of the Skin Dose Limit for Hot Particles toOther External Sources of SkinIrradiation
’’
(March 30, 2001).An individual commenter, a certifiedhealth physicist, noted the need torevise the whole-body limits specifiedin 10 CFR part 20 to use effective-doseequivalent (EDE) rather than deep-doseequivalent (DDE). The commentersuggested that the risk associated withthe DDE from a DRP at 1 centimeter wasnot comparable to the risk associatedwith DDE to the whole body. The NRCstaff agrees that consideration should begiven to adopting the EDE concept in itssystem of dose limitation. However, thatissue is not relevant to the rule changesaddressed in this final rule. The skindose limit concerns only SDE, and theassertion that the associated DDE hasminimal stochastic risk would be evenmore accurate if an EDE were used. Therule, as promulgated, is believed toreduce unnecessary regulatory burden,while providing increased workerprotection. The NRC staff is separatelyaddressing questions regarding EDE andthe use of weighting factors fordetermining whole-body doses.The Nuclear Energy Institute (NEI)solicited comments from its industryradiation protection members andsubmitted a letter of strong support forthe rulemaking. NEI noted that the rulehas a strong scientific basis, reflectsNCRP recommendations that were basedon replicated research studies, andincorporates a risk-based approach thatwill permit licensees to select protectivemeasures that optimize worker safety.The commenter observed that the rulechange is an easily implementedsimplification that will permit reductionof external radiation exposure and resultin an overall improvement in workersafety.NEI noted that the rule would changethe way licensees estimate the dose tothe skin, but would not change existing
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of 00

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