ML20202D322

Refers to 850405 EDO Memo Which Established Procedures for Ensuring That Complete Reg History Compiled for Each RM Action.Discusses Procedures for Compiling Reg History Package

ML20202D322
Person / Time
Issue date:	10/27/1998
From:	Mendiola D NRC OFFICE OF ADMINISTRATION (ADM)
To:	Tanious N NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS)
Shared Package
ML20202D294	List: ML20202D290 ML20202D322
References
FRN-63FR13372, FRN-63FR54559, RULE-PR-72 AF84-2-002, AF84-2-2, NUDOCS 9902010365
Download: ML20202D322 (13)

Text

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a t UNITED STATES g g NUCLEAR REGULATORY COMMISSION

& WASHINGTON, D.C. 206eH001 October 27,1998

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MEMORANDUM TO: Naiem S. Tanious Office of.N ai Wraterial Safety and Safeguards

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FROM: D5ris Men i .

R les and Di c es Br Div sion of A inistrative Services Office of Administration

SUBJECT:

REGULATORY HISTORY PROCEDURES - MINOR REVISION OF DESIGN BASIS ACCIDENT DOSE LIMITS FOR INDEPENDENT SPENT FUEL STORAGE AND MONITORED RETRIEVABLE STORAGE  !

INSTALLATIONS (10 CFR PART 72)

In a memorandum dated April 5,1985 (copy attached), the Executive Director for Operations established procedures for ensuring that a complete regulatory history is compiled for each rulemaking action undertaken by an office under his purview. These procedures are applicable to any proposed or final rule submitted for publication in the Federal Register after April 5,1985.

Briefly, these procedures require that-Documents of central relevance to a rulemaking be maintained, and identified for a source of access; and An index of documents comprising the regulatory history be developed and submitted to the Rules and Directives Branch (RDB) within 60 days after the rulemaking is completed. l The rulemaking that amends the regulations governing the dose limits and the dose calculational methodology used in design basis accident analyses for ISFSis and MRS, was published on October 13,1998 (63 FR 54559).

You should forward the completed index for this rule to the RDB (T6-D59) by December 31, 1998. In your transmittal memorandum to NUDOCS, please include the title of the rule, the complete Federal Register citation, and a listing of all parts affected by the document.

You should place the designator "AF84-2"in the upper right-hand corner of each document centrally relevant to the rulemaking, including the transmittal memorandum, that you send to the Nuclear Document System (NUDOCS), Mail Stop OWFN P1-17. Each document transmitted to NUDOCS that can be made available to the public should be marked "PDR" in the upper right-l hand corner of the front page. Documents that cannot be made available to the public should be marked "CF"(Central Files) in the upper right-hand corner of the first page. In addition, CF <

documents should be grouped after the PDR documents to streamline the microfiching process.

9902010365 990125 PDR PR l 72 63FR13372 PDR  !

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Naiem S. Tanicus l Check all attachments to each document marked "PDR" to ensure that no documents to be 1 withheld are inadvertently released. SECY Papers concerning rulemaking issues are generally l released to the public. The Staff Requirements Memorandum (SRM) generally contains instructions from SECY that indicate when and if a SECY Paper, the SRM, and Commission vote sheets may be made available to the public. Any questions concerning the release of any

SECY Paper, SRM, or Commissioner vote sheet must be coordinated with the Office of the Secretary. Commission vote sheets may be released to the public if so stated on the vote sheet.

Commission vote sheets and SECY Papers that are to be withheld. should be marked " Central Files oniv."

l Approximately two weeks after you submit the documents to the NUDOCS you should receive a l computer printout listing the documents you submitted to the NUDOCS. If you do not receive

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this printout within two or three weeks, call the Customer Support System, IRM (415-1234), you will then be transferred to NUDOCS. You should forward a copy of this printout, which comprises the regulatory history index, to the RDB.

I in addition, please proofread the codified text of the final rule as it was published in the Federal

Register and inform us of any errors that may have occurred in typesetting the document. RDB 1 will arrange for an appropriate correction before the codified text is included in the subsequent edition of the Code of Federal Regulations, if you cannot meet the December 31,1998, deadline, please let me know. If you have any questions call me at 415-6297.

Attachment:

As stated I

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Federal Register /Vol. 63. No.197/ Tuesday, October 13,1998/ Rules and Regulations 54559 advantage of this growing market, and to to express their views on this issue. meated tomatoes, and single layer and improve returns to producers, the Finally, interested persons are invited to two layer place packed tomatoes are committee recommended these changes. submit information on the regulatory exempt from the container net weight According to committee funded and informational impacts of this action requirements specified in paragraph research, retailers consider vine. ripe on small businesses. (a)(3)(i) of this section, and the tomatoes to be the tomato type of the After consideration of all relevant requirement that each container or lid future. This has been a market that has material presented, including the shall be marked to indicate the been expanding and it is a market where committee's recommendation, and other designated net weight as specified in the Florida tomato industry has room to information, it is found that this interim paragraph (a)(3)(ii) of this section, but grow and expand its market share. The final rule, as hereinafter set forth, will must meet the other requirements of this committee believes that producer field. tend to effectuate the declared policy of section. Producer field-packed tomatoes packed tomato will increase the volume the Act. are also exempt from the container net of vine-ripe tomatoes available from This rule invites comments on a weight requirements specified in Florida. The committee also believes change to the handling requirements paragraph (a)(3)(i) of this section, the that it will allow producers to harvest currently prescribed under the Florida requirement that each container or lid tomatoes that might otherwise have tomato marketing order. Any comments shall be marked to indicate the been left in the field. There is also an received will be considered prior to designated net weight as specified in indication that handlers will be willing finalization of this rule. paragraph (a)(3)(ii) of this section, and  !

to pay a higher price for producer field- Pursuant to 5 U.S.C. 553,it is also the requirement that all containers must packed tomatoes. The committee found and determined upon good cause be packed at the registered handler's believes that the higher prices combined that it is impracticable, unnecessary, facilities as specified in paragraph .

with additional tomato sales should and contrary to the public interest to (a)(3)(ii) of this section, but must meet increase returns to producers. give preliminary notice prior to putting the other requirements of this section.

There are some additional costs this rule into effect and that good cause . . . . .

associated with packing in the field. exists for not postponing the effective Picking, gradmg, and sizing by hand is date of this rule until 30 days after (g) Definitions. Hydroponic tomatoes more time consuming and costly than means tomatoes grown in solution publication in the Federal Register . without soil: greenhouse tomatoes by machine. Ilowever, there are because: (1) This change is a relaxation indications that producer field. packed of current requirements; (2) the Flonda means tomatoes grown indoors:

tomatoes will command a higher price. tomato season begins October to:(3) the specialtypacked red ripe tomatoes i Also, the regulated industry is not committee unanimously recommended means tomatoes which at the time of required to use this exemption. these changes at a pubhc meeting and inspection are as or *6 color (according Therefore, the additional costs are to color classification requirements in mterested parties had an opportunity t voluntary' provide input; and (4) this rule provides the U.S. tomato standards) with their These changes are intended to a 60-da) comment period and any calyx ends and stems attached and cell provide additional flexibility for all comments received will be considered packed in a single layer container; and those covered under the order. The producerfield. packed tomatoes means prior to finalization of this rule.

tomatoes which at the time of e ex; ec e to ua 1 a a b o List of Subjects in 7 CFR Part 966 inspection are '3 color or higher all tomato handlers and growers Marketing agreements, Reporting and (according to color classification regardless of their size of operation. recordkeeping requirements. Tomatoes. requirements in the U.S. tomato This action will hase a beneficial For the reasons set forth in the standards), that are picked and place impact on producers and handlers since preamble,7 CFR part 966 is amended as Packed in new containers in the field by it will allow tomato handlers to make follows: a producer as defined in 5 966.150 and additional supplies of tomatoes transferred to a registered handler,s available to meet consumer needs PART 966-TOMATOES GROWN IN facilities for final preparation for consistent with crop and market FLORIDA market. * *

• conditions. Dated: October 8,19tfl. j This rule will not impose any L The authonty citation for 7 CFR part 966 continues to read as follows: Robert C. Keeney, additional reporting or recordkeeping Deputy Admmistrator, fruir and vegetable i requirements on either small or large Authority: 7 U.S C 60t-674. Progmms.

tomato handlers. As with all Federal 2. Section 966.323 is amended by IFR Doc. 98-27518 Filed 10-9-98; 8 45 aml marketing order programs. reports and revising paragraph (d)(1) and the first sw o coor uSci e forms are periodically reviewed to .,entence in paragraph (g) to read as reduce information requirernents and follows:

duplication by industry and public sectors. In addition, the Department has $ 966.323 Handung regulations NUCLEAR REGULATORY not identified any relevant Federal rules * * - *

• COMMISSION that duplicate. merlap or conflict with (d) Exemption. (1) For types. The this rule. following types of tomatoes are exempt 10 CFR Part 72 Further. the committee's meeting was from these regulations: Elongated types widely publicized throughout the

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commonly referred to as pear shaped or FUN 3150-AFB 4 tomato industry and all interested paste tomatoes and including but not Minor Revision of Design Basis persons were invited to attend the hmited to San Marzano. Red Top, and Accident Dose Limits for independent meeting and participate m committee Roma varieties: cerasiform type Spent Fuel Storage and Monitored i deliberations. Like all committee tomatoes commonly referred to as Retrievable Storage installations I meetings, the September 11.1998, cherry tomatoes; hydroponic tomatoes; meeting was a pubhc meeting and all and greenhouse tomatoes. Specialty AGENCY: Nuclear Regulator) entities both large and smali. were able packed red ripe tomatoes. yellow Commission.

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n 54560 Federal Register /Vol. 63, No.197 / Tuesday, October 13,1998/ Rules and Regulations ACTION: Final rule. The committed dose equivalent rem). The amendment also includes a (CDE)(Ht33)is defined in 10 CFR separate dose limit for the lens of the

$UMMARY:The Nuclear Regulatory 20.1003 to mean the dose equivalent to eye of 0.15 Sv (15 rem); and for the skin Commission (NRC) is amending its organs or tissues of reference (T) that or any extremity, a shallow dose regulations governing the dose limits will be received from an intake of equivalent of 0.5 Sv (50 rem). The use and the dose calculational methodology radioactive material by an individual

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of separate dose limits for the lens of the used in design basis accident analyses during the 50-year period following the eye, skin, and extremities will conform '

for Independent Spent Fuel Storage intake. The comimrted effective dose with the dose calculational Installations (ISFSIs) and Monitored equivalent (CEDE) (H6.so) is defined in methodology used in part 20 and will Retrievable Storage Installations (MRSI. 10 CFR 20.1003 as the sum of the ensure that no observable effects (e g.,

This final rule amends ISFSI and MRS products of the weighting factors induction of cataracts in the lens of the design basis accident dose limits to applicable to each of the body organs or eye) will occur as a result of any conform to the dose calculational tissues that are irradiated and the accidental radiation exposure.

methodology currently used in the committed dose equivalent to these This final rule makes S 72.106 regulations that specify standards for organs or tissues (Ho.3o = IW T Hr.30). The consistent with part 20 dose protection against radiation and make a total e#ective dose equivalent (TEDE) is calculational methodology. This rule minor change to match the the sum of the deep-dose equivalent (for also provides pan 72 licensees l Environmental Protection Agency's external exposure) and the committed flexibility when performing design basis (EPA) regulations. This action will effective dose equivalent (for internal accident analyses because they would ensure that limits for design basis exposuresl. be able to use organ weighting factors to i accidents at ISFSI and MRS installations The ICRP-26 methodology wcs not calculate the dose to the maximally are consistent with the dose incorporated into part 72 at the time exposed organ. In addition, part 72 methodology specified in NRC radiation part 20 was revised. Part 72 contains licensees will no longer need to comply protection regulations, and will allow two regulations setting dose limits: with one calculational methodology for licensees the flexibility provided by that S 72.104, which sets dose limits during their radiation protection programs (i.e.,

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dose methodology when performing normal operations and anticipated the revised part 20 methodology) and design basis accident analyses. occurrences; and S 72.106, which sets another methodology for their design EFFECTIVE DATE: November 12,1998. dose limits for design basis accidents basis accident analyses.

. The main objective of this final rule This final rule does not revise FOR FURTHER INFORMATION CONTACT:

is to revise S 72.106(b) to incorporate the S 72.104(a) to incorporate ICRP-26 Naiem S. Tanious. Office of Nuclear methodology because doing so would part 20 methodology. A second i Material Safety and Safe 8uards, U.S render this regulation incompatible with objective of the rule is to make a minor j Nuclear Regulatory Commission, <

- Pb word change to S 72.104(a) to match the thewhich EPA's regulationtoatISFSI is applicable 40 CFRand 191.03(a)

MRS j language used by EPA in 40 CFR (30145 503 - a1 191.03(a) licensees. However,40 CFR 191.03(a)

INTERNET:NST@nrc gov On March 19, li 38 (63 FR 13372), the phrases the standard in terms of dose SUPPLEMENTARY INFORMATION: NRC published the notice of proposed limits to the whole body and any critical Background rulemaking that would amend ISFSI wi ormm; whereas, S 72.104(a) phrases the MRS design basis accident dose limits standard in terms of dose limits to the Paragraph (b) of 5 72.106 establishes to conform to the dose calculational whole body and any organ. This final the dose hmit for a design basis accident methodolog'y currently used in 10 CFR rule makes S 72.104(a) more consistent at an independent spent fuel storage part 20, and to make a minor change to with 40 CFR 191.03(a) by inserting the installation (ISFSI) or a momtored S 72.104(a) to match EPA's regulation in word critical before the word organ. The  ;

retrievable storage installation (MRS). 40 CFR 191.03(a). The public comment critical oq;an (listed in Table 1 of ICRP- )

The dose limit in S 72.106(b)is based on period expired May 4,1998. 2) associated with an intake of the dose calculational methodology radioactive materialis considered to be contained in laternational Commission Discussion that organ of the body whose damage by on Radiological Protection Publication At present, S 72.106 Controlled area the radiation results in the greatest Number 2 (ICRP-2,1959). The ICRP-2 of an ISFSI or MRS in part provides- damage to the body.

methodology was subsequently revised (b) Any individuallocated on or This final rule adopts the term " Lens l in ICRP Publication Number 26 (ICRP- beyond the nearest boundary of the dose equivalent" in S 72.106 which 26,1977), and was incorporated into 10 controlled area shall not receive a dose replaces the term " Eye dose CFR pan 20 w hen part 20 was revised greater than 5 rem to the whole body or equivalent". This new term was added in 1991. any organ from any desig,n basis to part 20 in an NRC final rule ,

The calculational methodology in the accident. The minimum distance from published on July 23,1998 (63 FR l revised part 20 no longer quantifies dose the spent fuel or high level radioactive 39477).  ;

in terms of whole body dose and waste handling and storage facilities t Public Comments on the Proposed Rule i

individual organ dow Instead, the dose the nearest boundary of the controlled is quantified as a nsk equivalent dose area shall be at least'190 meters The NRC received two public in this manner, the doses absorbed by This 0.05 Sv (5 rem) limit to the comments: one from the Nuclear Energy the whole body and the individual ' whole body or any organ is amended in Institute (NEI), an organization that organs can be summed to a single the final rule to conform with the part represents the nuclear energy industry, quantity relating to rak 20 dose calculational methodology. The . r.d the other from TSW Enterprises, a Under the part 20 calculational amended limit becomes the more private company Both commenters methodology, deep-dow equn olent hmitmg of the TEDE of 0.03 Sv (5 rem), supported the proposed rule. NEl, u hile (Ha), which ' applies to the esternal or the sum of the deep dose equivalent expressing disappointment that NRC whole body esposure,is defined in 10 and the committed dose equivalent to was not amendmg 4 72.104(a) because CFR 20.1003 as the dow equivalent at any inda idual organ or tissue luther this would create incompatibihtv with a tissue depth of I cm (1000 mg/cm:1 than the lens of the eye) of 0 5 Sv (50 EPA's regulation, urged the NRC to

O Federal Register /Vol. 63, No.197 / Tuesday, October 13,1998/ Rules and Regulations 54561

proceed with the revisions as proposed. Thus. licensees would not be able to The final rule will not impose any TSW Enterprises also supported the take advantage of the flexibility additional obligations on entities that proposed rule and suggested that in provided by the dose calculational may fall within the definition of"small

$ 72.104(a) the radiation exposure limits methodology used in part 20 when entities" as set forth in section 601(3) of be expressed in metric units as well as performing design basis accident the Regulatory Flexibility Act; or within !

English units in accord with the analyses. Therefore, this alternative was the definition of"small business" as Commission's policy on the use of not pursued. found in section 3 of the Small Business ' ,

metric units (61 FR 31169). The 2. Amendments of 20 CFR part 72. In Act.15 U.S.C. 632: or within the size Commission agrees with this suggestion this option, the staff considered standards adopted by the NRC on Apnl j and this change is made in the final preparing a proposed rule to amend the 11,1995 (60 FR 18344).  ;

rule. dose limiting design objective in. , Small Business Regulatory Enforcement '

Criminal Penalties S 72.106(b) to 5 rem TEDE. This is Fairness Act consistent with the intent of the existing l For purposes of section 223 of the S 72.106(b), and updates the dose in accordance with the Small l Atorme Energy Act ( AEA), the calculational methodology to that which Business Regulatory Enforcement  ;

Commission is issuing the final rule is used for demonstration of compliance Fairness Act of 1996, the NRC has l under one or more of sections 161b,161: with part 20. Updating the dose determined that this action is not a or 161o of the AEA. Willful violations calculational methodology also would " major rule" and has verified this of the rule will be subject to criminal increase the organ dose limit, CDE, from determination with the Office of enforcement. 5 rem to 50 rem: allow for the use of Information and Regulatory Affairs.

EnvironmentalImpact: Categorical risk based weighting factors for each Office of Management and Budget.

l Exclusion organ or tissue to determine the 50. year Backfit Analysis CEDE: and provide licensees with l The NRC has determined that this additional flexibility in conducting and The NRC has determined that the final rule is the type of action described submitting design basis accident backfit rule,5 72.62, does not apply to in categorical exclusion 10 CFR analyses t demonstrate compliance 51.22(c)(2). Therefore, neither an this final rule. and a backilt analysis is with the requirements in 5 72.106(b). not required, because these amendments environmental impact statement nor an In addition to the increased flexibility do not involve any provisions that environmental assessment have been r vided to hcensees, they would no would impose backfits as defined m, prepared for this regulation. fonger need to comply with one 6 72.62(a). This final rule does not Paperwork Reduction Act Statement calculational methodology for their constitute a backfit under S 72.62.

This final rule does not contain a new radiation protection programs (i.e., the because it does not require a change to or amended information collection revised part 20 methodology) and existing structures, systems, l

requirement subject to the Paperwork an ther methodology for their design components, procedures, or Reduction Act of 1995 (44 U.S.C,3501 basis accident analyses. organization. Further, the rule will not Moreom, design basis accident result in a more stringent outcome than et seq.). Existing requirements were analym for ISFSIs and MRS the existing rule, and therefore, current approved by the Office of Management f nstallations would use the same dose licensees who are in compliance with I and Budget, approval number 3150_

0132. calculational methodology as design the existing rule will not be required to ,

basis accident analyses for a geologic make any changes or take any action. 1 Public Protection Notification repository operatio'ns area (6 60.136(b)). New applicants and license renewal If an information collection does not This alternative was chosen by the NRC. applications will be able to take display a currently valid OMil control This constitutes the regulatory advantage of some additional flexibility number, the NRC may not conduct or analysis for this final rule. As discussed in the dose calculations that is afforded sponsor, and a person is not required to above, this rule does not impose any by this rule.

respond to, the information collection. new requirements. Therefore, there will Agreement State lmplementation Issues

. be no additional cost burden to part 72 Regulatory Analysis licensees or the Federal Government. Under the " Policy Statement on To determine whether the Adequacy and Compatibility of Regulatory Flexibility Certification Agreement State Programs, approved by amendments to 10 CFR part 72 are  ;

appropriate, the NRC staff considered As required by the Regulatory the Commission on June 30,1997,(62 the following two alternatives: Flexibility Act of 1980,5 U.S.C. 605(b). FR 46517), this rule is classified as a

1. The No. Action Alternotive This the Commission certifies that this rule compatibility Category "NRC." This rule alternatis e is not acceptable to the NRC will not have a significant economic is not required for compatibility and for the followmg reasons Section impact upon a substannal number of addresses areas of exclusive NRC 72106(b) would continue to be small entities. The fmal rule will authority.This area of regulations inconsistent with part 20 Part 72 provide licensees with additional cannot be relinquished to Agreement licensees wc.uld demonstrate flexibility in conducting and submitting States pursuant to the Atomic Energy comphance with the dose limits in part design basis accident analyses to Act and. as such. States should not 20 using the 1977 dose calculatmnal demonstrate compliance with the adopt this regulation.

methodology of ICRP-26 for their requirements in % 72.106fb) In addition

• List of subjects in 10 CFR Part 72 l radiation protection programs as the licensees would no longer nead to I required by 6% 72.24!el and 72 44(d). comply with one calculational Cnminal penalties. Manpower l

However, part 72 hcensnes would methodology for their radiation training programs Nuclear materials.

continue to use the 1959 dose protection procrams (i.e., the revised Occupational safety and health, culculational methodolop of ICRP-2 in part 20 methodology) and anotbr Reporting and recordkeeping addressmg radiation dose trom a desien methodology for their design basis requirements Secunty maasures. Spent basis accident as required in s 72106(b) accident anahdes fuel 1

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54562 Federal Register /Vol. 63, No.197/Tuesd8y, October 13,1998/ Rules and Regulations For the reasons set out in the 672.106 Controlled area of an ISFSI or result in the pilot having to manually preamble and under the authority of the M RS. overpower the elevator trim control a' nd Atomic Energy Act of 1954 as amended; * * * *

• possibly lose directional control of the the Energy Reorganization Act of 1974, (b) Any individuallocated on or as amended; and 5 U.S C. 553, the airplane during entical phases of flight.

l beyond the nearest boundary of the DATES: Effectise November 20,1998.

Commission is adoptmg the following controlled area may not receive from The incorporation by reference of amendments to 10 CFR part 72. any design basis accident the more certain publications listed in the limiting of a total effective dose wgulations is approved by the Director PART 72-LICENSING REOUIREMENTS FOR THE equivalent of 0.05 Sv ($ rern), or the sum of the Federal Register as of November of the deep-dose equivalent and the 20,1998.

INDEPENDENT STORAGE OF SPENT committed dose equivalent to any NUCLEAR FUEL AND HIGH LEVEL ADDRESSES: Service information that individual organ or tissue (other than applies to this AD may be obtained from RADIOACTIVE WASTE the lens of the eye) of 0.5 Sv (50 rem). British Aerospace Reg'ional Aircraft.

The lens dose equivalent shall not

1. The authority citation for part 72 Prestwick International Airport, continues to read as follows: exceed 0.15 Sv (15 rem) and the shallow Avrshire, KA9 2RW, Scotland; dose equivalent to skin or to any telephone: (012921479888; facsimile:

Authority: Secs. 51.53,57,62.63,65.69, extremity shall not exceed 0.5 Sv (50 81,161.182,183,184,186,187,189. 68 Stat. rem). The minimum distance from the (01292) 479703. This information may 929,930,932,933,934,935,948,953,954. spent fuel or high level radioactive also be examined at tLe Federal 955, as amended, sec. 234,83 Stat. 444, as Aviation Administration (FAA), Central amended (42 U.S.C 2071,2073,2077,2092-waste handling and storage facilities to Region, Office of the Regional Counsel.

l the nearest boundary of the controlled Attention: Rules Docket No. 98-CE 2 2 7, 3 2 2h: et 274 P'ub. area must be at kast 100 meters- AD, Room 1558,601 E.12th Street.

L 86-373,73 Stat. 688 as amended (42 Kansas City. Missouri 64106; or i * )

U.S C 2021); sec. 201, as amended.202,206 Dated at Rockville. Maryland, this 24th day Office of the Federal Register,80; Jorth 88 Stat.1242, as amended. 1244,1246(42 I1998' Capitol Street, NW, suite 700, U.S C. 5841. 5842,5846) Pub. L 95-601. sec. For the Nuclear Regulatory Commission Washington, DC.

10,92 Stat. 2951 as amended by Pub. L 102- L loneph Callan, 486, sec. 7902,106 Stat. 3123 (42 U.S C FOR FURTHER INFORMaTION CONTACT: Mr.

5851), sec.102, Pub. L.91-190,83 Stat. 853 frecutne threctorfor Opemisons S M. Nagarajan, Aerospace Engineer.

IFR Doc. 98-27349 Filed 10.-9-98,8.45 am] FAA, Small Airplane Directorate.1201 137,1 1 Pub . 7 25 t t 2229 2230, SpG cod Meo-M Walnut, suite 900 Kansas City, Missouri 2232,2241, sec.148, Pub. L 100-203, tot 64106; telephone: (816) 426-6932; Stat.1330-235 (42 U.S C 10151.10152, facsimile: (816) 426-2169.

10153,10155,10157.10161,10168).

! DEPARTMENT OF TRANSPORTATION SUPPLEMENTARY INFORMATION:

Section 72 44(g) also issued under secs. 142(b) and 148(c). (d), Pub. L 100-203.101 Federal Aviation Administration Events Leading to the Issuance of This Stat.1330-232,1330-236 (42 U.S C. AU 10162(b).10168(c),(d)). Section 72.46 also 14 CFR Part 39 issued under sec.189,68 Stat. 955 (42 U.S.C. A proposal to amend part 39 of the 2239); sec.134. Pub. L 97-425,96 Stat. 2230 [ Docket No. 96-CE-42-AD; Amendment 39- Federal Aviation Regulations (14 CFR (42 U.S.C 10154). Section 72.96(d) als 10822; AD 98-21-13] Part 39) to include an AD that would asued under sec.145(g), Pub. L 100-203, RIN 2120-A A64 apply to certain British Aerospace 101 Stat.1330-235 (42 U.S C 10165(g)). ktham Model 3101 airplanes was ,

Subpart I also issued under secs. 2(2),2(15). Airworthiness Directives; British published in the Federal Register as a 2(19),117(a),141(h) Pub. L 97-425. 96 Stat. n dce I Proposed rulemaking (NI RM)

Aerospace Jetstream Model 3101 2202. 2203,2204,2222,2224142 U.S C n June 17,1998 (63 FR 33018). The 10101,10137(a),10161[h)) Subparts K and L Airplanes are also issued under sec.133,98 Stat. 2230 NPRM proposed to require replacing the AGENCY: Federal Aviation elevator trim servo motor with one of 14; U.S.C 10153) and sec. 218tal. 96 Stat- Administration, DOT.

2252 (42 U.S C 101981 improved design; and inspecting the ACTION: Final rule. cable tension and electacal operation of

-' in 6 72.104, the introductory text of the elevator and trim tab for proper paragraph (a)is revised to read as SUMuARY:This amendment adopts a operation, and making any necessary I II *" new airworthiness directive ( AD) that adiustments. Accomplishment of the i

l applies to certain British Aerospace proposed actions as specified in the

$ 72.104 Crtteria for radioactive materials Jetstream Model 3101 airplanes. This NPRM would be in accordance with in emuents and direct radiation from an AD requires replacing the elevator trim letstream Service Bulletin 22-A-IA ISFSI or MRS. Servo motor with a new motor of 860413. ORIGINAL ISSUE: April 16.

impr ved design; and inspecting the 1986, and British Aerospace Alert (a) Durin8 normal oIwrations and

" " cable tension and electrical operation of Service Bulletin Jetstream 22-A-lA 3[3P" the elevator and trim tab for proper 9" [nt t -

d d operation, and making any necessary 851231, ORIGINAL ISSUE: April 9 who is located beyond the controlled 1986.

adjustments. This AD is the result of The NPRM was the result of area must not exceed 0 25 mSv (25 mrem) to the whole body. 0 75 mss. (75 mandatory continuing airworthiness mandatory continuing airworthiness mrem) to the thyroid and 0.25 mss (25 information (MCA1) issued by th. inforrnation (MCA1) issued by the mrem) to any other critical organ as a airworthiness authonty for the United airworthiness authority for tlie United result of exposure to: Kins; dom. The actions specified by this Kingdom.

AD'are intended to prevent the elevator Interested persons have been afforded trim servo motor dris e gear assernbly an opportunity to participate in the

3. !n S 72.106, paragraph (b) is revised from remaining engaged when the malmg of this amendment. No to read as follows: autopilot is disengaged, which could i omments were recen ed on the l

e =

/-esasegk UNITED STATES

- 8 g NUCLEAR REGULATORY COMMISSION WASHINGTON, D. C. 20066 O.

\, APR 0 51985 MEMORANDUM FOR: Robert B. Minogue, Director Office of Nuclear Regulatory Research Harold R. Denton, Director Office of Nuclear Reactor Regulation l

John G. Davis, Director l Office of Nuclear Material Safety & Safeguards i l

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James M. Taylor Director l Office of Inspection and Enforcement l Patricia G. Norry, Director Office of Administration Guy H. Cunningham, III l Executive Legal Director

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G. Wayne Kerr, Director Office of State Prograns Clemens J. Heltemes, Jr., Director Office for Analysis and Evaluation of Operational Data James R. Shea. Director Office of International Programs FROM: William J. Dircks Executive Director for Operations

SUBJECT:

REGULATORY HISTORY PROCEDURES In a February 15, 1985 memorandum to Chairman Palladino, issued jointly I with the Office of General Counsel, I informed the Chairman that procedures I would be developed for the creation of a regulatory history of each proposed and final rulemaking initiated by the offices reporting to the EDO.

This memorandum outlines the individual office responsibilities for the implementation of the regulatory history procedures. The objective of the (

regulatory history is to ensure that all documents of central relevance to a particular rulemaking are identified and accessible. This will facilitate the resolution of any issues that may arise concerning the interpretation of a particular regulation. The following procedures will be applicable to any i proposed or final rule submitted to the Federal Register for publication i af ter the date of this menorandum. The Rules and Procedures Branch, Office

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.of Administration, will provide further infomation on these procedures, as '

necessary, in the periodic revision of the NRC Regulations Handbook, ,

NUREG/BR-0053.

Program Office Responsibilities Each office that sponsors a proposed or final rulemaking shall ensure that: i

1. all documents of central relevance to the factual basis, i coverage, meaning, and historical development of the rulemaking  ;

are identified, and maintained during the course of the  ;

rulemaking. Although the Project Manager's judgment will be i necessary in some instances to determine whether specific l documents are of " central relevance" to a rulemaking, the i following documents should be included: '

l

. the Office of Nuclear Regulatory Research (RES) Independent Review Package (containing the RES recommendations on whether to proceed with the rulemaking, the sponsoring Office's recommendation to proceed with rulemaking, and the evaluation of the rulemaking proposal against the six criteria required for the RES Independent Review)

. prior drafts of the rulemaking transmitted for interoffice review

. fomal-Office comments on the drafts submitted for interoffice review ,

.- source documents relied upon in preparing the draft rule (e.g.

research studies, consensus standards endorsed in the draft rule)

. documents which synthesize or organize data in a form relied upon in the draft rule

. supporting documentation such as the regulatory analysis, the Cost Analysis Group Report, environmental assessment nr environmental impact statement, regulatory flexibility i analysis, and OMB Clearance Package  ;

I

. public comments submitted in response to a Petition for l

Rulemaking, an Advanced Notice of Proposed Rulemaking, or a Notice of Proposed Rulemaking

. Committee to Review Generic Requirements (CRGR) minutes and reconnendations concerning the draf t rule l

l

. the ACRS connents on'the draft rule

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. the Comission Paper transmitting the draft rule to the '

Comission or the memorandum transmitting the rule to the ,

EDO for approval l l

. the transcript or sumary of the Comission meeting or briefing on consideration of the draft rule

. the Staff Requirements memo containing the Comission recommendations on the draft rule

. the Federal Register Notice for the rule (Petition for Rulemaking, Advanced Notice of Proposed Rulemaking, Notice of Proposed Register Rulemaking, notice Final Rule, issued concerning or any)other Federal the rule

. any other documents of central relevance (e.g. interagency correspondence, agreement state correspondence)

Documents that fall within any of the above categories must be typewritten rather than handwritten to pennit conversion into microfiche by the Document Control System (DCS). If the only record of substantive office review comments on a draft rule are contained as handwritten annotations on the draft itself, the Project Manager should sumarize these coments in a typed note to the file.

2. At the completion of a particular rulemaking action, i.e.

publication of the proposed or final rule, the project manager' shall compile an index of all documents that comprise the regulatory history file. The Project Manager is responsible for identifying a source of access for each document listed.

For internal documents, this will require the Project Manager to ascertain whether each document listed is available in the DCS. The Project Manager must ensure that any internal document not already available in the DCS is placed in the DCS, and that the record's accession number is identified for each document on the index. In the case of published documents (e.g. NUREGS, NTIS publications, books, articles, etc.), it will be sufficient to include the bibliographic citation for that document. The Project Manager shall forward the completed index to the Rules and Procedures Branch, Office of Administration, within sixty days after the completion of the rulemaking. The title of the index, and the file, should be the name nf the rule and applicable NRC citation (e.g. 10 CFR Part 50) as it appears in the Federal Register notice, the Federal Register citation and date of publication, l

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The Rules and Procedures Branch, Office of Administration, will be )

responsible for ensuring that a completed index of the documents comprising j the regulatory history has been compiled for each proposed and final '

rulemaking. The Rules and Procedures Branch is also responsible for retaining the index and for disseminating copies of the index to interested NRC offices.

(SigneeWilliam1.Dittks William J. Dircks Executive Director for Operations cc: Herzel H.E. Plaine, GC DISTRIBUTION FXCameron WJ0lmstead OELD R/F 1 OELD S/F Regs R/F i Central File ED0 R/F EDO 223 14Dircks JRoe TRehm VStello Regional Administrators RM s

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Fed:rcl Regist:r/Vol. 63, No.197/ Tuesday, October 13,1998/ Rules and Regulations TN N O 54559 advantage of this growing market, and to to express their views on this issue. meated tomatoes, and single layer and improve returns to producers, the Finally, interested persons are invited to two layer place packed tomatoes are committee recommended these changes. submit information on the regulatory exempt from the container net weight According to committee funded and informationalimpacts of this action mquirements specified in paragraph research, retailers consider vine-ripe on small businesses. (a)(3)(1) of this section, and the tomatoes to be the tomato type of the After consideratiori af all relevant requirement that each container or lid future. This has been a market that has material presented, including the shall be marked to indicate the been expanding and it is a market where committee's recommendation, and other designated net weight as specified in the Florida tomato industry has room to inforroation, it is found that this interim paragraph (a)(3)(ii) of this section, but grow and expand its market share. The final rule, as hereinafter set forth, will must meet the other requirements of this committee believes that producer field. tend to effectuate the declared policy of section. Producer field-packed tomatoes packed tomato willincrease the volume the Act. are also exempt from the container net of vine-ripe tomatoes available from This rule invites comments on a weight requirements specified in Florida. The committee also believes change to the handling requirements paragraph (a)(3)(1) of this section, the that it will allow producers to harvest currently prescribed under the Florida requirement that each container or lid tomatoes that might otherwise have tomato marketing order. Any comments shall be marked to indicate the been left in the field. There is also an received will be considered prior to designated net weight as specified in i indication that handlers will be willing finalization of this rule- paragraph (a)(3)(11) of this section, and to pay a higher price for producer field. Pursuant to 5 U.S.C. 553, it is also the requirement that all containers must packed tomatoes. The committee found and determined upon good cause be packed at the registered handler's believes that the higher prices combined that it is impracticable, unnecessary, facilities as specified in paragraph with additional tomato sales should and contrary to the public interest to (a)(3)(ii) of this section. but must meet increase retums to producers. give preliminary notice prior to putting the other requirements of this section.

There am some additional costs this rule into effect and that good cause associated with packing in the field. exists for not postponing the effectve Picking, grading, and sizing by hand is date of this rule until 30 days after "Pon. tn more time consuming and costly than ' publication in the Federal Register I(*[. in , 9n by machine. However, there are because: (1) This change is a relaxation without soil: greenhouse tomatoes indications that producer field. packed of current requirements: (2) the Florida means tomatoes grown indoors:

tomatoes will command a higher price. tomato season begins October to; (3) the specialtypacked red ripe tomatoes Also, the regulated industry is not committee unanimously recommended means tomatoes which at the time of required to use this exemption. these changes at a public meeting and inspection are '5 or '6 color (according Therefore, the additional costs are interested parties had an opportunity t to color classification requirements in voluntary. provide input; and (4) this rule provides the U.S. tomato standards) with their These changes are intended to '

a 60-day comment period and any calY* ends and stems attached and cell provide additional flexibility for all comments received will be considered Packed in a single layer container; and those covered under the order. The prior to finalization of this rule. Pmducerfield-pocked tomatoes means opportunities and benefits of this rule tomatoes which at the time of are expected to be equally available to List of Subjects in 7 CFR Part 966 inspection are '3 color or higher all tomato handlers and growers Marketing agreements, Reporting and (according to color classincation

!' regardless of their size of operation. recordkeeping requirements, Tomatoes. requirements in the U.S. tomato This action will have a beneficial For the reasons set forth in the standards), that are picked and place impact on producers and handlers sinc

• preamble,7 CFR part 966 is amended as Packed in new containers in the field by it will allow tomato handlers to make follows, '

a producer as defined in $ 966.150 and additional supplies of tomatoes transferred to a registered handler's available to meet consumer needs PART 966-TOMATOES GROWN IN facilities for final preparation for consistent with crop and market FLORIDA market. * * *

-conMons. Dated: October 8,1998.

This rule will not impose any 1.The authority citation for 7 CFR part 966 continues to read as follows: Robert C. Keeney, additional reporting or recordkeeping Deputy Administrator, Fruit and Vegetable 1

requirements on either small or large Authority: 7 U.S.C. 601-674. p,,g,,,,,

tomato handlers. As with all Federal

2. Section 966.323 is amended by (FR Doc. 96-275t8 Filed 10-9-98; 8:45 am] l marketing order programs, reports and revising paragraph (d)(1) and the first I forms are periodically reviewed to a coacmuw sentence in paragraph (g) to read as i reduce information requirements and follows: I duplication by industry and public sectors. In addition, the Department has $ 966.323 Handling regulations NUCLEAR REGULATORY I not identified any relevant Federal rules * * * *

• COMMISSION I that duplicate, overlap or conflict with (d) Exemption. (1) For types. The l this rule. following types of tomatoes are exempt 10 CFR Part 72 Further, the committee's meeting was from these regulations: Elongated types , g widely publicized throughout the commonly referred to as pear shaped or tomato industry and allinterested paste tomatoes and including but not Minor Revision of Design Basis persons were invited to attend the lunited to San Marzano, Red Top, and Accident Dose Limits for independent l meeting and participate in committee Roma varieties: cerasiform type Spent Fuel Storage and Monitored delibera+1ons. Like all committee tomatoes commonly referred to as Retrievable Storage installations meetings, the September 11,1998, cherry tomatoes hydroponic tomatoes: .

meeting was a public meeting and all and greenhouse tomatoes. Specialty AGENCY: Nuclear Regulatory i entities, both large and small, were able packed red ripe tomatoes, yellow Commission.

I

54560 I )

Federal Regist:r/Vol. 63 No.197/Tu sday, October 13,1998/Ruhs and Regulations {

ACTION: Final rula. The committed dose equivalent l rem). The amendment also includes a

SUMMARY

The Nuclear Regulatory (CDE)(Hr.so)is defined in 10 CFR separate dose limit for the lens of the l

20.1003 to mean the dose equivalent to eye of 0.15 Sv (15 rem); and for the skin Commission (NRC)is amending its k l organs or tissues of reference (T) that or any extremity, a shallow dose regulations governing the dose limits will be received from an intake of equivalent of 0.5 Sv (50 rem). The use and the dose calculational methodology radioactive material by an individual of separate dose limits for the lens of the used in design basis accident analyses during the 50-year period following the eye, skin, and extremities will conform for Independent Spent Fuel Storage Installations (ISFSis) and Menitored intake. The committed effective dose with the dose calculational equivalent (CEDE) (Hs.so) is defined in methodology used in part 20 and will Retrievable Storage Installations (MRS)- 10 CFR 20.1003 as the sum of the This final rule amends ISFSI and MRS ensure that no observable effects (e.g.,

products of the weighting factors induction of cataracts in the lens of the design basis accident dose limits to conform to the dose calculational apolicable to each of thebody organs or eye) will occur as a result of any tissues that are irradiated and the accidental radiation exposure. '

methodology currently used in the committed dose equivalent to these regulations that specify standards for This final rule makes S 72.106 organs or tissues (Hg.so = IW T Hr.so). The consistent with part 20 dose protection against radiation and make a total effective dose equivalent (TEDE)is calculational methodology. This rule minor change to match the the sum of the deep-dose equivalent (for also provides part 72 licensees EnvironmentalProtection Agency's external exposure) and the comm8tted (EPA) regulations. This action will flexibility when performing design basis effective dose equivalent (for internal accident analyses because they would ensure that limits for design basis exposures). be able to use organ weighting factors to I accidents at ISFSI and MRS installations The ICRP-26 methodology was not calculate the dose to the maximally are consistent with the dose incorporated into part 72 at the time exposed organ. In addition, part 72  !

methodology spec 1 Sed in NRC radiation part 20 was revised. Part 72 contains licensees will no longer need to comply protection regulations, and will allow }

two regulations setting dose limits: with one calculational methodology for licensaes the flexibility provided by that S 72.104, which sets dose limits during their radiation protection programs (i.e.,

dose methodology when performing normal operations and anticipated the revised part 20 methodology) and design basis acciderit analyses. occurrences; and $ 72.106, which sets another methodology for their design EFFECTIVE DATE: November 12,1998. dose limits for design basis accidents. basis accident analyses.

FOR FURTHER INFORMATION CONTACT: .

e main oMe@e oms Enal Me Ms hal ruk h not Mse .

Naiem S. Tanlous. Office of Nuclear is to revise $ 72.106(b) to incorporate the $ 72.104(a) to incorporate ICRP-26 l Maten.al Safety and Safeguards U.S part 20 mithodology. A second methodology because doir3g no would Nuclear Regulatory Commission, objective of the rule is to make a minor render this regulation incompatible with .

Washington, DC 20555-0001, telephone word change to S 72.104(a) to match the the EPA's regulation at 40 CFR 191.03(a) '

(301) 415-6103. E-mail. language used by EPA in 40 CFR which is applicable to ISFSI and MRS 1 :NSThgov 191.03(a) licensees. However,40 CFR 191.03(a)

On March 19,1998 (63 FR 13372), the phrases the standard in terms of dose SUPPLEMENTAR7 lNFORMATION:

NRC published the notice of proposed limits to the whole body and any critical Background rulemaking that would amend ISFSI and organ; whereas, $ 72.104(a) phrases the l MRS design basis accident dose limits standard in terms of dose limits to the

! Paragraph (b) of $ 72.106 establishes the dose limit for a design basis accident to conform to the dose calculational whole body and any organ. This final at an independent spent fuel storage methodology currently used in to CFR rule makes $ 72.104(a) more consistent part 20, and to make a minor change to with 40 CFR 191.03(a) by inserting the installauon (ISFSI) or a monitored retrievable storage installation (MRS). S 72.104(a) to match EPA's regulation in word critical before the word organ. The The dose limit in S 72.106(b) is based on 40 CFR 191.03(a). The public comment critical organ (listed in Table 1 ofICRP-the dose calculational methodology period expired May 4,1998. 2) associated with an intake of contained in International Commission Discussion radioactive material is considered to be on Radiological Protection Publication that organ of the body whose damage by At present, S 72.106, Controlled area the radiation results in the greatest

• Number 2 (ICRP-2,1959). The ICRP-2 of an ISFSI or MRS in part provides: damage to the body.

methodology was subsequently revised (b) Any individuallocated on or This final rule adopts the term " Lens in ICRP Publication Number 26 (ICRP- beyond the nearest boundary of the dose equivalent" in S 72.100 which 26,1977), and was incorporated into 10 controlled area shall not receive a dose replaces the term " Eye dose CFR part 20 when part 20 was revised greater than 5 rem to the whole body or equivalent". This new term was added in 1991. any organ from any design basis to part 20 in an NRC final rule The calculational methodology in the accident. The minimum distance from published on July 23,1998 (63 FR revised part 20 no longer quantifies dose the spent fuel or high-level radioactive 39477).

in terms of whole body dose and waste handling and storage facilities t individual organ dose Instead, the dose the nearest boundary of the controlled Public Comments on the Proposed Rule '

is quantified as a risk equivalent dose. area shall be at least 100 meters. The NRC received two public i In this manner, the doses absorbed by This 0.05 Sv (5 rem) limit to the comments: one from the Nuclear Energy the whole body and the individual organs can be summed to a single whole body or any organ is amended in Institute (NEI), an organization that '.

the final rule to conform with the part represents the nuclear energy industry, quantity relating to risk. 20 dose calculational methodology. The and the other from TSW Enterprises, a Under the part '.0 calculational amended limit becomes the more private company. Both commenters (

methodology, deep-dose equivalent limiting of the TEDE of 0.05 Sv (5 rem), supported the proposed rule. NEl. while ,

(R). which applies to the external or the sum of the deep dose equivalent expressing disappointment that NRC whole-body exposure, is defined in 10 and the committed dose equivalent to was not amending $ 72.104(a) because CFR 20.1003 as the dose equivalent at any individual organ or tissue (other this would create incompatibility with a tissue depth of I cm (1000 mg/cm2). than the lens of the eye) of 0.5 Sv (50 EPA's regulation, urged the NRC to

Federd Regist:r/Vol. 63, No.197/Tuisd:y, October 13,1998/Rul:s and Regulations 54561 proceed with the revisions as proposed. Thus, licensees would not be able to The final rule will not impose any TSW Enterprises also supported the take advantage of the flexibility additional obligations on entities that j proposed rule and suggested that in provided by the dose calculational may fall within the definition of "small S 72.104(a) the radiation exposure limits methodology used in part 20 when entities" as set forth in section 601(3) of be expressed in metric units as well as performing design basis accident the Regulatory Flexibility Act; or within English units in accord with the analyses. Therefore, this alternative was the definition of"small business" as Commission's policy on the use of not pursued. found in section 3 of the Small Business metric units (61 FR 31169). The 2. Amendments of10 CFR part 72. In Act,15 U.S.C. 632: or within the size Commission agrees with this suggestion this option, the staff considered standards adopted by the NRC on April and this change is made in the final preparing a proposed rule to amend the 11,1995 (60 FR 18344).

rule. dose limiting design objective in Small Business Regulatory Enforcement l Criminal Penaldes S 72.106(b) to 5 rem TEDE. This is . Fairnus Act consistent with the intent of the ex2 sting l For purposes of section 223 of the S 72.106(b), and updates the dose in accordance with the Small l Atomic Energy Act (AEA), the calculational methodology to that which Business Regulatory Enforcement l Commission is issuing the final rule is used for demonstration of compliance Fairness Act of 1996, the NRC has under one or more of sections 161b,161: with part 20. Updating the dose determined that this action is not a or 1610 of the AEA. Willful violations calculational methodology also would " major rule" and has verified this l

of the rule will be subject to criminal increase the organ dose limit, CDE, from determination with the Office of I enforcement. 5 rem to 50 rem: allow for the use of Information and Regulatory Affairs, EnvironmentalImpact: Categorical risk-based weighting factors for each Office of Management and Budget.

Exclusion organ or tissue to determine the 50-year Backfit AnalIsis CEDE: and provide licensees with The NRC has determined that this additional nexibility in conducting and The NRC has determined that the

" ' ctio escribed submitting design basis accident backfit rule, S 72.62, does not apply to go ' xc

' b*d 1 analyses to demonstrate compliance this final rule, and a backfit analysis is 51.22(c)(2). Therefore, neither an with the requirements in S 72.106(b). not required, because these amendments i envirnnmentalimpact statement nor an in addition to the increased flexibility do not involve any provisions that I environmental assessment have been rovided to licensees, they would no would impose backfits as defined in Prepared for this regulation. fonger need to comply with one S 72.62(a). This final rule does not Paperwork Reduction Act Statement calculational methodology for their constitute a bacuit under S 72.62.

This final rule does not contain a new radiation protection programs (i.e., the because it does not require a change to ,

or amended information collection revised part 20 methodology) and existing structures, systems, l another methodology for their design components, procedures, or requirement subject to the Paperwork basis accident analyses. organization. Further, the rule will not Reduction Act of 1995 (44 U.S.C. 3501 Moreover, design basis accident result in a more stringent outcome than et seq.). Existing requirements were the existing rule, and therefore, current approved by the OHice of Management analyses for ISFSIs and MRS and Budget, approval number 3150- installations would use the same dose licensees who are in compliance with 0132. calculational methodology as design the existing rule will not be required to basis accident analyses for a geologic make any changes or take any action.

Public Protection Notification repository operations area ($ 60.136(b)). New applicants and license renewal If an information collection does not Tais alternative was chosen by the NRC. applications will be able to take display a currently valid OMB control This constitutes the regulatory advantage of some a'dditional flexibility number, the NRC may not conduct or analysis for this final rule. As discussed in the dose calculations that is afforded sponsor, and a person is not required to above, this rule does not impose any by this rule.

respond to, the informetion collection. new requirements. Therefore, there will Agreement State Implementation Issues be no additional cost burden to part 72 Regulatory Analysis licensees or the Federal Government. Under the " Policy Statement on To determine whether the Adequacy and Compatibility of amendments to 10 CFR part 72 are Regulatory MexW MHcation Agreement State Programs" approved by appropriate, the NRC staff considered As required by the Regulatory the Commission on June 30,1997, (62 the following two altematives: Flexibility Act of 1980,5 U.S.C. 605(b), FR 46517), this rule is classified as a

1. The No-Action Alternative.This the Commission certifies that this rule compatibility Category "NRC." This rule alternative is not acceptable to the NRC will not have a significant economic is net required for compatibility and for the following reasons. Section impact upon a substantial number of addresses areas of exclusive NRC 72.106(b) would continue to be small entities. The final rule will authority. This area of regulations inconsistent with part 20. Part 72 provide licensees with additional cannot be relinquished to Agreement licensees would demonstrate flexibility in conducting and submitting States pursuant to the Atomic Energy compliance with the dose limits in part design basis accident analyses to Act and, as such, States should not 20 using the 1977 dose calculational demonstrate compliance with the adopt this regulation.

methodology of ICRP-26 for their

, requirements in S 72.106(b). In addition. List of Subjects in 10 CFR Part 72 radiation protection pr< ; rams as the bcensees would no longer need to required by SS 72.24(e) and 72.44(d). comply with one calculational Criminal penalties, Manpower However, part 72 licensees would methodoiogy for their radiation training programs. Nuclear materials, l continue to use the 1959 dose protection programs (i.e., the revised Occupational safety and health, l calculational methodology cf ICRP-2 in part 20 methodology) and another Reporting and recordkeeping addressing radiation dose from a design methodology for their design basis requirements, Security measures. Spent basis accident as required in S 72.106(b). accident analyses. fuel.

"54562 Federal Register /Vol', 63, No.197/Tu:sday, October 13,1998/ Rules and Regulations  ;

For the reasons set out in th2 5 72.106 controlled aree cf an ISFSI or \

preamble and under the authority of the MRS. result in the pilot having to manually -

Atomic Energy Act of 1954, as amended: overpower the elevator trim control and  !

f '. * * * *

• possibly lose directional control of the l the Energy Reorganization Act of 1974, (b) Any individuallocated on or  !

as amended; and 5 U.S.C. 553, the beyond the nearest boundary of the airplane during critical phases of flight.

Commission is adopting the following DATES: Effective November 20,1998.

controlled area may not receive from amendments to 10 CFR part 72. The incorporation by reference of any design basis accident the more certain publications listed in the limiting of a total effective dose PART 72-4.lCENSING regulatiora is approved by the Director REOUIREMENTS FOR THE equivalent of 0.05 Sv (5 rem), or the sum of the Federal Register as of November of the deep-dose equivalent and the 20,19 A.

INDEPENDENT E .ORAGE OF SPENT committed dose equivalent to any NUCLEAR FUEL AND HIGH-LEVEL individual organ or tissue (other than ADDRESSES: Service information that RADIOACTIVE WASTE the lens of the eye) of 0.5 Sv (50 rem). applies to this AD may be obtained from The lens dose equivalent shall not British Aerospace Regional Aircraft,

1. The authority citation for part 72 exceed 0.15 Sv (15 rem) and the shallow PrestwickInternational Airport, continues to read as follows: A .rshire, KA9 2RW, Scotland; dose equivalent to skin or to any te ephone:(01292) 479888; fact:imile:

Authority: Secs. 51,53.57,62,63,65,69, extremity shall not exceed 0.5 Sv (50 81,181,182,183,184,186,187,189,68 Stat. rem). The minimum distance from the (01292) 479703, This information may

, 929,930,932,933,934,935,948,953,954, spent fuel or high. level radioactive also be examined at the Federal 955, as amended, sec. 234,83 Stat. 444, as Aviation Administration (FAA), Central amended (42 U.S.C 2071,2073,2077,2092, waste handling and storage facilities to the nearest boundary of the controlled Region, Office of the Regional Counsel, area must be at least 100 meters. Attention: Rules Docket No. 98-CE 2 4, 2 ,2 7,'223 2 2); sec 274 Pub. AD, Room 1558,601 E.12th Street, L 86-373,73 Stat. 688, as amended (42 Kansas City, Missouri 64106; or at the U.S.C 2021); sec. 201, as amended 202,206, Dated at Rockville, Maryland, this 24th day Office of the Federal Register,800 North 88 Stat.1242. as arnended.1244,1246 (42 of 1998.

U.S.C 5841,5842,5848); Pub. L 95-601, sec.

Capitol Street, NW, suite 700, For the Nuclear Regulatory Conunission. Washington, DC.

10,92 Stat. 2951 as amended by Pub. L 102- L Joseph Callan, 486, sec. 7902,106 Stat. 3123 (42 U.S.C FOR FURTHER INFORMATl0N CONTACT: Mr.

5851); sec.102, Pub. L 91-190,83 Stat. 853 Executive Dhectorfor Opemtions.

S.M. Nagarajan, Aemspace Engineer, 32 IFR Doc. 98-27349 Filed 10-9-98; 8.45 um) FAA, Small Airplane Directorate,1201 (42 3,, U 25,96 t 2229 2230, a u se code 7se6 4 .P Walnut, suite 900, Kansas City. Missouri 2232,2241, sec.148. Pub. L 100-203,101 64106; telephone: (816) 426-6932; Stat.1334-235 (42 U.S.C 10151.10152, facsimile: (816) 426-2169.

10153,10155,10157,10161,10168).

Section 72.44(g) also issued under secs. DEPARTMENT OF TRANSPORTATION SUPPLEMENTARY INFORMATION:

(

142(b) and 148(c). (d), Pub. L 100-203,101 Events Imading to the Issuance of This ,

Stat.1330-232,1330-236 (42 U.S.C.

Federal Aviation Administration AD 10162(b) 10168(c),(d)). Section 72.46 also 14 CFR Part 39 issued under sec.189,68 Stat. 955 (42 U.S.C A proposal to amend part 39 of the 2239); sec.134, Pub. L 97-425,96 Stat. 2230 [ Docket No. 98 CE-32-AD; Amendment 39- Federal Aviation Regulations (14 CFR (42 U.S.C 10154). Section 72.96(d) also 108223 AD 96-21-13) Part 39) to include an AD that would -

issued under sec.145(g), Pub. L 100-203, apply to certain British Aerospace RIN 21204A64 101 Stat.1330-235 (42 U.S.C 10165(g)). Jetstream Model 3101 airplanes was Subpart J also inued under secs. 2(2). 2(15). Airworthiness Directives; British Published in the Federal Register as a 2[19),117(a),141[h), Pub. L 97-425, M Stat. n tace of pmposed rulemaking (NPRM) 2202,2203,2204. 2212,2224 (42 U.S.C Aerospace Jetstream Model 3101 10101,10137(a),10161(h)). Subparts K and L Airplanes n June 17,1998 (63 R 33018h he NPRM proposed to require replacing the are also issued under sec.133. 98 Stat. 2230 AGENCY: Federal Aviation (42 U.S.C 10153) and sec. 218(a),96 Stat- elevator trim servo motor with one of Administration, DOT. Improved design; and inspecting the 2252 (42 U.S.C 10198).

ACTION: Final rule. cable tension and electrical operation of 2, in 5 72.104, the introductory text of the elevator and trim tab for proper paragraph (a)is revised to read as

SUMMARY

This amendment adopts a operation, and makin any necessary follows: new airworthiness directive (AD) that adjustments. Accomp ishment of the applies to certain British Aerospace proposed actions as specified in the i 572.104 Crtierta for redlooctNo materiets Jetstream Model 3101 airplanes. This NPRM would be in accordance with in effluente and direct radiation from an AD requires replacing the elevator trim ISFSI or MRS, Jetstream Service Bulletin 22-A-JA servo motor with a new motor of 860413 ORIGINALISSUE: April 16, (a) During normal operations and improved design; and inspecting the 1986,and British Aerospace Alert r.nticipated occurrences, the annual cable tension and electrical operation of Service Bulletin Jetstream 22-A-JA dose equivalent to any real individual the elevator and trim tab for proper 851231, ORIGINAL ISSUE: April 9, who is located beyond the controlled operation, and making any necessary 1986.

adjustments. This AD is the result of The NPRM was the result of area must not exceed 0.25 mSv (25 mrem) to the whole body,0.75 mSv (75 mandatory continuing airworthiness mandatory continuing airworthiness mrem) to the thyroid and 0.25 mSv (25 information (MCA1) issued by the information (MCA1) issued by the mrem) to any other critical organ as a a rworthiness authority for the United airworthiness authority for the United result of exposure to: Kingdom. The actions specified by this Kingdom.

AD are intended to prevent the elevator Interested persons have been afforded trim servo motor drive gear assembly an opportunity to participate in the

3. In S 72.106, paragraph (b) is revised from remaining engaged when the making of this amendment. No to read as follows: autopilot is disengaged, which could comments were received on the

l ., 5 2' W W8A $

l4 DOCl;E TED n NVMdtn s . iq ir -

RCPOSED RULE Efi 7A (wosm)  %* $'i"/4 ni :27 l NUCLEAR REGULATORY COMMISSION O l

10 CFR Part 72 RIN: 3150-AF84 Minor Revision of Design Basis Accident Dose Limits for independent Spent Fuel Storage and Monitored Retrievable Storage installations AGENCY: Nuclear Regulatory Commission.

)

l ACTION: Final rule.

SUMMARY

The Nuclear Regulatory Commission (NRC) is amending its regulations governing the dose limits and the dose calculational methodology used in design basis accident analyses for Independent Spent Fuel Storage Installations (ISFSis) and Monitored Retrievable Storage i

installations (MRS). This final rule amends ISFSI and MRS design basis accident dose limits to j conform to the dose calculational methodology currently used in the regulations that specify standards for protection against radiation and make a minor change to match the l Environmental Protection Agency's (EPA) regulations. This action will ensure that limits for design basis accidents at ISFSI and MRS installations are consistent with the dose methodology specified in NRC radiation protection regulations, and will allow licensees the l

flexibility provided by that dose methodology when performing design basis accident analyses.  ;

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W I2,I998 EFFECTIVE DATE: (30 d yr ah^r d" cf p2ket.en in ihu Fodmai Rog,;;a).

FOR FURTHER INFORMATION CONTACT: Naiem S. Tanious, Office of Nuclear Material Safety and Safeguards, U.S Nuclear Regulatory Commission, Washington, DC 20555-0001, telephone (301) 415-6103, E-mail: INTERNET:NST@nrc. gov ,

SUPPLEMENTARY INFORMATION:

Background

Paragraph (b) of @ 72.106 establishes the dose limit for a design basis accident at an independent spent fuel storage installation (ISFSI) or a monitored retrievable storage installation (MRS). The dose limit in 9 72.106(b) is based on the dose calculational methodology contained in International Commission on Radiological ,)rotection Publication Number 2 (ICRP-2,1959). The ICR'P-2 methodology was subsequently revised in ICRP Publication Number 26 (ICRP-26,1977), and was incorporated into 10 CFR Part 20 when Part 20 was revised in 1991.

The calculational methodology in the revised Part 20 no longer quantifies dose in terms ,

of whole body dose and individual organ dose. Instead, the dose is quantified as a risk equivalent dose. In this manner, the doses absorbed by the whole body and the individual organs can be summed to a single quantly relating to risk.

Under the Part 20 calculational methodology, deep-dose equivalent (H,), which applies to the external whole-body exposure, is defined in 10 CFR 20.1003 as the dose equivalent at a  ;

tissue depth of 1 cm (1000 mg/cm r). The committed dose equivalent (CDE)(H 7,w) is defined in 10 CFR 20.1003 to mean the dose equivalent to organs or tissues of reference (T) that will be received from an intake of radioactive material by an individual during the 50-year period 2 l l

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-e. l following the intake. The committed effective dose equivalent (CEDE) (He.3.) is defined in l 10 CFR 20.1003 as the sum of the products of the weighting factors applicable to each of the  !

body organs or tissues that are irradiated and the committed dose equivalent to these organs or ,

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tissues (He,so = Ewr Hr, o). The totaleffective dose equivalent (TEDE) is the sum of the deep-dose equivalent (for external exposure) and the committed effective dose equivalent (for ,

internal exposures). r The ICRP-26 methodology was not incorporated into Part 72 at the time Part 20 was

' revised.- Part 72 contains two regulations setting dose limits: 9 72.104, which sets dose limits during normal operations and anticipated occurrences; and 6 72.106, which sets dose limits for

, i design basis accidents.  ;

The main objective of this final rule is to revise $ 72.106(b) to incorporate the Part 20 t

methodology. A second objective of the rule is to make a minor word change to 9 72.104(a) to j match the language used by EPA in 40 CFR 191.03(a). i On March 19,1998 (63 FR 13372), the NRC published the notice of proposed rulemaking that would amend ISFSI and MRS design basis accident dose limits to conform to the dose calculational methodology currently used in 10 CFR Part 20, and to make a minor l change to 6 72.104(a) to match EPA's regulation in 40 CFR 191.03(a). The public comment period expired May 4,1998.

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8 Discussion At present,9 72.106, Controlled area of an ISFSI or MRS in part provides:

(b) Any individuallocated on or beyond the nearest boundary of the controlled ,

area shall not receive a dose greater than 5 rem to the whole body or any organ i

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from any design basis accident. The minimum distance from the spent fuel or high-level radioactive waste handling and storage facilities to the nearest boundary of the controlled area shall be at least 100 meters.

This 0.05 Sv (5 rem) limit to the whole body or any organ is amended in the final rule to conform with the Part 20 dose calculational methodology. The amended limit becomes the more limiting of the TEDE of 0.05 Sv (5 rem), or the sum of the deep dose equivalent and the committed dose equivalent to any individual organ or tissue (other than the lens of the eye) of 0.5 Sv (50 rem). The amendment also includes a separate dose limit for the lens of the eye of 0.15 SV (15 rem); and for the skin or any extremity, a shallow dose equivalent of 0.5 Sv (50 rem). The use of separate dose limits for the lens of the eye, skin, and extremities will conform with the dose calculational methodology used in Part 20 and will ensure that no observable effects (e.g., induction of cataracts in the lens of the eye) will occur as a result of any accidental radiation exposure.

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. This final rule makes 6 72.106 consistent with Part 20 dose calculational methodology.

This rule also provides Part 72 hcensees flexibility when performing design basis accident analyses because they would be able to use organ weighting factors to calculate the dose to the maximally exposed organ. In addition, Part 72 licensees will no longer need to comply with one calculational methodology for their radiation protection programs (i.e., the revised Part 20 methodology) and another methodology for their design basis accident analyses. ,

This final rule does not revise $ 72.104(a) to incorporate ICRP 26 methodology because doing so would render this regulation incompatible with the EPA's regulation at 40 CFR

.191.03(a) which is applicable to ISFSI and MRS licensees. However,40 CFR 191.03(a) phrases the standard in terms of dose limits to the whole body and any critical organ; whereas,

- 72.104(a) phrases the standard in terms of dose limits to the whole body and any organ. This 4

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final rule makes 72.104(a) more consistent with 40 CFR 191.03(a) by inserting the word critica/ before the word organ. The critical organ (listed in Table 1 of ICRP-2) associated with I an intake of radioactive material is considered to be that organ of the body whose damage by the radiation results in the greatest damage to the body.

This final rule adopts the term " Lens dose equivalent" in 72.106 which replaces the term " Eye dose equivalent". This new term was added to Part 20 in an NRC final rule published on July 23,1998 (63 FR 39477).

Public Comments on the Proposed Rule The NRC received two public comments: one from the Nuclear Energy Institute (NEI),

an organization that represents the nuclear energy industry, and the other from TSW Enterprises, a private company. Both commenters supported the proposed rule. NEl, wh%

l egressing disappointment that NRC was not amending 72.104(a) because this would create incompatibility with EPA's regulation, urged the NRC to proceed with the revisions as proposed.

TSW Enterprises also supported the proposed rule and suggested that in 72.104(a) the i

radiation exposure limits be expressed in metric units as well as English units in accord with the Commission's policy on the use of metric units (61 FR 31169). The Commission agrees with this suggestion and this change is made in the final rule.

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Criminal Penalties l l

l For purposes of Section 223 of the Atomic Energy Act (AEA), the Commission is issuing the final rule under one or more of sections 161b,161: or 161o of the AEA. Willful violations of the rule will be subject to criminal enforcement.

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1 EnvironmentalImpact: Categorical Exclusion The NRC has determined that this final rule is the type of action described in categorical exclusion 10 CFR 51.22(c)(2). Therefore, neither an environmental impact statement nor an environmental assessment have been prepared for this regulation. -

Paperwork Reduction Act Statement This final rule does not contain a new or amended information collection requirement subject to the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.). Existing '

requirements were approved by the Office of Management and Budget, approval number 3150-0132.

Public Protection Notification if an information collection does not display a currently valid OMB control number, the NRC may not conduct or sponsor, and a person is not required to respond to, the information collection.

Regulatory Analysis To determine whether the amendments to 10 CFR Part 72 are appropriate, the NRC staff considered the following two alternatives: l 6

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1. The No-Action Alternative. This alternative is not acceptable to the NRC for the l ' following reasons. Section 72.106(b) would continue to be inconsistent with Part 20. Part 72 l

licensees would demonstrate compliance with the dose limits in Part 20 using ue 1977 dose calculational methodology of ICRP 26 for their radiation protection programs as required by 99 72.24(e) and 72.44(d). However, Part 72 licensees would continue to use the 1959 dose calculational methodology of ICRP-2 in addressing radiation dose from a design basis accident as required in 9 72.106(b). Thus, licensees would not be able to take advantage of the flexibility provided by the dose calculational methodology used in Part 20 when performing design basis accident analyses. Therefore, this alternative was not pursued.

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2. Amendments of 10 CFR Part 72. In this option, the staff considered preparing a proposed rule to amend the dose limiting design objective in 9 72.106(b) to 5 rem TEDE. This is consistent with the intent of the existing 72.106(b), and updates the dose calculational methodology to that which is used for demonstration of compliance with Part 20. Updating the dose calculational methodology also would increase the organ dose limit, CDE, from 5 rem to 50 rem; allow for the use of risk-based weighting factors for each organ or tissue to determine

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the 50-year CEDE; and provide licensees with additional flexibility in conducting and submitting '

design basis accident analyses to demonstrate compliance with the requirements in 9 72.106(b).

In addition to the increased flexibility provided to licensees, they would no longer need to  !

I comply with one calculational methodology for their radiation protection programs (i.e., the I

revised Part 20 methodology) and another methodology for their design basis accident  !

analyses.

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Moreover, design basis accident analyses for ISFSis and MRS installations would use

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l the same dose calculational methodology as design basis accident analyses for a geologic repository operations area ($ 60.136(b)). This altemative was chosen by the NRC.

l This constitutes the regulatory analysis for this final rule. As discussed above, this rule does not impose any new requirements. Therefore, there will be no additional cost burden to Part 72 licensees or the Federal Government.

Regulatory Flexibility Certification 4

As required by the Regulatory Flexibility Act of 1980,5 U.S.C. 605(b), the Cornmission certifies that this rule will not have a significant economic impact upon a substantial number of small entities. The final rule will provide licensees with additional flexibility in conducting and l

submitting design basis accident analyses to demonstrate compliance with the requirements in  ;

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$ 72.106(b). In addition, the licensees would no longer need to comply with one calculational methodology for their radiation protection programs (i.e., the revised Pa,-t 20 methodology) and another rpethodology for their design basis accident analyses.

I The final rule will not impose any additional obligations on entities that may fall within the definition of 'small entities" as set forth in Section 601(3) of the Regulatory Flexibility Act; or l

within the definition of 'smal: business' as found in Section 3 of the Small Business Act, 15 U.S.C. 632; or within the size standards adopted by the NRC on April 11,1995 (60 FR 18344).

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Small Business Regulatory Enforcement Fairness Act i

I In accordance with the Small Business Regulatory Enforcement Fairness Act of 1996, the NRC has determined that this action is not a " major rule" and has verified this determination l with the Office of Information and Regulatory Affairs, Office of Management and Budget.

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I Backfit Anatysis l l

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The NRC has determined that the backfit rule,6 72.62, does not apply to this final rule, and a backfit analysis is not required, because these amendments do not involve an)f provisions that would impose backfits as defined in 9 72.62(a). This final rule does not constitute a backfit  !

under 72.62, because it does not require a change to existing structures, systems, components, procedures, or organization. Further, the rule will not result in a more stringent  !

outcome than the existing rule, and therefore, current licensees who are in compliance with the existing rule will not be required to make any changes or take any action. New applicants and license renewal applications will be able to take advantage of some additional flexibility in the dose calculations that is afforded by this rule.

Agreement State implementation issues j Under the " Policy Statement on Adequacy and Compatibility of Agreement State Programs" approved by the Commission on June 30,1997, (62 FR 46517), this rule is classified as a compatibility Category "NRC." This rule is not required for compatibility and addresses I areas of exclusive NRC authority. This area of regulations cannot be relinquished to I 9

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Agreement States pursuant to the Atomic Energy Act and, as such, States should not adopt this l regulation.

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List of Subjects in 10 CFR Part 72 j i

Criminal penalties, Manpower training programs, Nuclear materials, Occupational safety ,

i and health, Reporting and recordkeeping requirements, Security measures, Spent fuel. l t

l For the reasons set out in the preamble and under the authority of the Atomic Energy Act of 1954, as amended; the Energy Reorganization Act of 1974, as amended; and 5 U.S.C.

553, the Commission is adopting the following amendments to 10 CM Part 72. l l

l; PART 72 -- LICENSING REQUIREMENTS FOR THE INDEPENDENT STORAGE '!

OF SPENT NUCLEAR FUEL AND HIGH-LEVEL RADIOACTIVE WASTE  !

1.. The authority citation for Part 72 continues to read as follows:

l AUTHORITY: Secs. 51,53,57,62,63,65,69,81,161,182,183,184,186,187,189, 68 Stat. 929,930,932,933,934,935,948,953,954,955, as amended, sec. 234,83 Stat. 444, as amended (42 U.S.C. 2071,2073,2077,2092,2093,2095,2099,2111,2201,2232,2233, 2234,2236,2237,2238,2282); sec. 274, Pub. L. 86 373,73 Stat. 688, as amended (42 U.S.C.

2021); sec. 201, as amended,202,206,88 Stat.1242, as amended, 1244,1246 (42 U.S.C.

- 5841,5842,5846); Pub. L.95-601, sec.10, 92 Stat. 2951 as amended by Pub. L. 102-486, sec.-7902,106 Stat. 3123 (42 U.S.C. 5851); sec.102, Pub. L.91-190,83 Stat. 853 (42 U.S.C.

4332); secs.131,132,133,135,137,141, Pub. L.97-425, 96 Stat. 2229, 2230, 2232, 2241,

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I sec.148, Pub. L 100-203,101 Stat.1330-235 (42 U.S.C.10151,10152,10153,10155,10157, 10161,10168).

Section 72.44(g) also issued under secs.142(b) and 148(c), (d), Pub. L. 100-203,101 l l

Stat.1330-232,1330-236 (42 U.S.C.10162(b),10168(c), (d)). Section 72.46 also issued under sec.189, 68 Stat. 955 (42 U.S.C. 2239); sec.134, Pub'. L.97-425,96 Stat. 2230 (42 U.S.C. .

10154). Section 72.96(d) also issued under sec.145(g), Pub. L.100-203,101 Stat.1330-255 (42 U.S.C.10165(g)). Subpart J also issued under secs. 2(2),2(15),2(19),117(a),141(h),

Pub. L.97-425, 96 Stat. 2202, 2203, 2204, 2222, 2224 (42 U.S.C.10101,10137(a),10161(h)).

Subparts K and L are also issued under sec.133,98 Stat. 2230 (42 U.S.C.10153) and sec. 218(a),96 Stat. 2252 (42 U.S.C.10198). '

2. In 72.104, the introductory sentence of paragraph (a) is revised to read as follows:

6 72.104 Criteria for radioactive materials in effluents and direct radiation from an ISFSI or MRS.

(a) During normal operations and anticipated occurrences, the annual dose equivalent to any real individual who is located beyond the controlled area must not exceed 0.25 mSv (25 mrem) to the whole body,0.75 mSv (75 mrem) to the thyroid and 0.25 mSv (25 mrem) to any other critical organ as a result of exposure to:

3. In 72.106, paragraph (b) is revised to read as follows:

6 72.106 Controlled area of an ISFSI or MRS.

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_ (b) Any individuallocated on or beyond the nearest boundary of the controlled area may

(. 'not receive from any design basis accident the more limiting of a total effective dose equivalent i

of 0.05 Sv (5 rem), or the sum of the deep-dose equivalent and the committed dose equivalent l <

to any individual organ or tissue (other than the lens of the eye) of 0.5 Sv (50 rem).

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The lens dose equivalent shall not exceed 0.15 Sv (15 rem) and the shallow dose equivalent to t

skin or to any extremity shall not exceed 0.5 SV (50 rem). The minimum distance from the 3

- spent fuel or high-level radioactive waste handling and storage facilities to the nearest boundary of the controlled area must be at least 100 meters. ,

Dated at Rockville, Maryland, this 2 Y day of 1998.

y For the Nuclear Regulatory Comminsion.  ;

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L Joseph Ca lla '

Executive Dis r for Operations.

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., NEI g g' 4 00CKFTED UR!% c NU(l!AR ENfRGY I N 5111 U T E L ette Hendricks

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May 4,1998 DOCKET NUMBER Mr. John C. Hoyle, Secretary PROPOSED RULE $ 742 U.S. Nuclear Regulatory Commission Washington, DC 20555-001 (43pyg/337g Attn: Rulemakings and Adjudications Staff /

SUBJECT:

Proposed Rule - 10 CFR Part 72, " Minor Revision of Design Basis Accident Dose Limits for Independent Spent Fuel Storage and Monitored Retrievable Storage Installations l' (63 Federal Register 13372 - March 19,1998)

Dear Mr. Hoyle:

The Nuclear Energy Institute (NEI), on behalf of the nuclear energy industry, has reviewed the subject proposed rule. We offer the following comments for consideration.

We are in support of the NRC proposal to revise the radiation dose criteria for -

analyzing design basis accidents at independent spent fuel storage and monitored retrievable storage installations to be consistent with current dose methodology specified in 10 CFR Part 20. ,

Adoption in Part 72 of the Part 20 dose methodology will afford enhanced flexibility when performing design basis accident analyses because licensees will be able to sum organ doses for comparison with a single effective dose equivalent criterion. Also, achieving consistency between Part 72 and Part 20 will avoid licensees having to continue to employ two different dose methodologies in the analysis, as is currently the case.

Unfortunately, NRC is not revising the Part 72 criteria for radioactive material in effluents and direct radiation dose from independent spent fuel storage and monitored retrievable storage installations because such a change would be

" incompatible with the Environmental Protection Agency's (EPA] regulation at 40 CFR 191.03(a)." The EPA regulation continues to employ an out-of-date dose

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. Mr. John C. Hoyle

'r May 4,1998 Page 2 methodology that is no longer utilized by national and international scientific organizations in the area of radiation protection.

This constraint in the rulemaking on achieving full consistency between Parts 72 and 20 with regard to dose methodology will have the effect of marginalizing the benefits underlying the proposed rule -enhanced flexibility and reduced regulatory burden. Despite this, we encourage NRC to proceed with revising the Part 72 radiation criteria as proposed.

We are aware of the Commission's efforts to seek resolution to the situation of overlap in regulatory authority between the NRC and EPA that results in duplicative, unnecessary, and burdensome situations such as this one in the proposed rule. We will continue to pursue avenues of our own in support of the Commission's efforts.

t If you have any questions or regarding these comments, please contact Mr. Ralph Andersen of our staff at 202 739-8111.

Sincerely, Lynnette Hendricks LXH/RLA/ead l

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DOCKETED USNRC TSW Enterprises 17045 Catalpa Court i

W W 26 P135 RockviHe, MD 20855 May 21,1998 OFF.

• ATTN: Rulemakings and Adjudic htStaff Secretary, U.S. Nuclear Regulat  ;

brnission- 11AFF DOCKET NUMBER Washington, DC 20555-0001 PROPOSED RULE PR 12

Reference:

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Proposed Rule to Amend 10 CFR Part 72 (63 FR 13372)

Gentlemen:

I support the proposed rule to amend 10 CFR 72.104 and 72106 with on 72.104 the radiation exposure limits should be expressed e comment. Inin metric units as section This approach would be consistent with the Commission's well as English units. on the use f policy as the approach taken in the proposed revision to sectiono72.106.

metric units as well I understand that this comment will be received would urge your consideration ofit nevertheless. afterI the close of th ment period; however, Sincerely, g

Garry Brochman President, TSW Enterprises

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%,tp2 3 13372 l Proposed Rules- w- i x+i-

. Vol. 63. No. 53 Thursday, March 19,1998 This section of the FEDERAL REGISTER 20852, between 7:30 am and 4:15 pm on (Hr.3o) is defined at S 20.1003 to mean contains notices to the pubhc of the proposed Federal workdays. - the dose equivalent to organs or tissues issuance of rules and regulations. The You may also provide comments via of reference (T) that will be received purpose of these notices is to grve interested the NRC's interactive rulemaking web from an intake of radioactive material by site through the NRC home page (http:/ an individual,during the 50-year period beSaNg t ea terbi /www.ntc. gov). This site provides the following the mtake. The committed rules' availability to upload comments as files effective dose equivalent (CEDE) (Hr,so)

(any format)if your web browser is defined at S 20.1003 as the sum of the NUCLEAR REGULATORY supports that function. For information products of the weighting factors about the interactive miemaking site, applicable to each of the body organs or COMMISSION contact Ms. Carol Gallagher, (301) 415- tissues that are irradiated and the 10 CFR Part 72 6215; e-mail CAG@nrc. gov. committed dose equivalent to these Certain documents related to this organs or tissues (Hs.so = IwrHr.50). The rulemaking, including comments total effective dose equivalent (TEDE) is RIN 3150-AF84 received, may be examined at the NRC the sum of the deep-dose equivalent (for Minor Revision of Design Basis Public Document Room,2120 L Street external exposure) and the committed Accident Dose Limits for independent NW. (Lower Level), Washington, DC. effective dose equivalent (for internal Spent Fuel Storage and Monitored These same documents also may be exposures).

viewed and downloaded electronically The ICRP-26 methodology was not Retrievable Storage installations via the interactive rulemaking website incorporated into Part 72 at the time AGENCY: Nuclear Regulatory established by NRC for this rulemaking. Part 20 was revised. Part 72 contains Commission. two regulations that specify dose limits:

FOR FURTHER INFORMATION CONTACT:

ACTION: Proposed rule. S 72.104, which sets dose limits during Naiem S. Tanlous. Office of Nuclear Material Safety and Safeguards, U.S. n rmal operations and anticipated

SUMMARY

The Nuclear Regulatory ccurrences; and S 72.106, which sets Nuclear Regulatory Commission, Commission (NRC) proposes to amend Washington, DC 20555-0001, telephone dose limits for design basis accidents.

its regulations governmg the dose limits (301) 415-6103: e-mail: Th,e main objective of this proposed rnd the dose calculational methodology INTERNET:NST@NRC. GOV mle is to rense S 72.106%o used in design basis accident analyses incorporate the methodology m, 10 CFR for Independent Spent Fuel Storage SUPPLEMENTARY INFORMATION: Part 20. A second objective of the rule Installations (ISFSI) and Monitored Background is to make a minor word change to Retrievable Storage Installations (MRS). S 72.104(a) to match the language used Para aph )o by EPA in 40 CFR 191.03(a).

This proposed rule would amend ISFSI est,) , s ibo a design ldent dose basis accident at an independent spent Discussion It o confo to th do,g fuel storage installation (ISFSI) or a At present. S 72.106(b), Controlled cciculational methodology currently m nit red retrieval storage mstallation area of an ISFSI or MRS provides:

used in the regulations that specify (MRS). The dose limit in S,72.106(b) is fbl Any individuallocated on or beyond standards for protection against based n the dose calculational ridiatio:a and make a minor change to the nearest boundary of the covroiled area methodology conta:,ned in Internatm.nal shall not receive a dose greater than 5 rem match the Environmental Protection Commission on Radiological Protection to the whole body or any organ from any A. 8encY's (EPA) "8ulations. This action. Publication Number 2 (ICRP-2,1959). design basis accident. The minimum distance is needed to make limits for design basis The ICRP-2 methodology was from the spent fuel or high-level radioactive accidents at ISFSI and MRS installations subsequently revised in ICRP waste handling and storage facilities to the consistent with dose methodology Publication Number 26 (ICRP-26,1977), nearest boundary of the controlled area shall specified in the regulations, and t be at least 100 meters.

and was incorporated into 10 CFR Part afford licensees the flexibility provided 20 when Part 20 was revised in 1991. This 0.05 Sv (5 rem) limit to the by dose methodology when performmg The calculational methodology in the whole body or any organ would be design basis accident analyses. revised Part 20 no longer quantifies dose amended in the proposed rule to DATES: The comment period expires in terms of whole body dose and conform with the Part 20 dose May 4,1998. Comments received after individual organ dose. Instead, the dose calculational methodology. The this date will be considered if it is is quantified as a risk equivalent dose. amended limit would become the mure practical to do so, but the Commission In this manner, the doses absorbed by limiting of the TEDE of 0.05 Sv (5 rem),

is able, to assure consideration only for the whole body and the individual or the sum of the deep dose equivalent comments received on or before this organs can be summed to a single and the committed dose equivalent to date. quantity relating to risk. any individual organ or tissue (other ADDRESSES: Mail written comments to: Under the Part 20 calculational than the lens of the eye) of 0.5 Sv (50 Secretary, U.S. Nuclear Regulatory methodology, deep-dose equivalent rem). The amendment would also Commission, Washington, DC 20555- (Hal, which applies to the external include a separate dose limit for the lens 0001. Attention: Rulemakings and whole-body exposure, is defined at 10 of the eye of 0.15 Sv (15 rem); and for Ad!udications Staff. Comments may be CFR 20.1003 as the dose equivalent at the skin or any extremity, a shallow delis ered to One White Flint North. a tissue depth of I cm (1000 mg/cm2). dose equivalent of 0.5 Sv (50 rem).The M 555 Rockville Pike. Rockville, MD The committed dose equivalent (CDE) use of separate dose limits for the eye,

Fid r:1 Register /Vol. 63 No. 53 / Thursday, March 19,1998 / Proposed Rules 13373 7 skin, and extremities would conform Public Protection Notification repository operations area (10 CFR with the dose calculational methodology used in Part 20 and would If an information collection does not 60.136(b)). This alteinative was chosen display a currently valid OMB control by the NRC.

ensure that no observable effects (e g.. number, the NRC may not conduct or This constitutes the regulatory induction of cataracts in the lens of the eye) would occur as a result of any sponsor, and a person is not required to analysis for this proposed rule. As respond to, the information collection. discussed above, this rule does not accidental radiation exposure. impose any new requirements.

This action would make S 72.106 Regulatory Analysis Therefore, there will be no additional consistent with Part 20 dose To determine whether the cost burden to Part 72 licensees or the calculational methodology. This action amendments to 10 CFR Part 72 are . Federal Government.

would also provide Part 72 licensees appropriate, the NRC staff considered flexibility when performing design basis the following two alternatives: Regula' tory Flexibility Certification accident analyses because they would As required by the Regulatory be able to use organ weighting factors to e M n A tern five Flexibility Act of1980,5 U.S.C. 605(b),

calculate the dose to the maximally This alternative is not acceptable to the Commission certifies that this rule, exposed organ. In addition, Part 72 the NRC for the following reasons. if adopted, will not have a sigmficant licensees would no longer need to Section 72.106(b) would continue to be economic impact upon a substantial comply with one calculational inconsistent with Part 20. Part 72 number of small entities. The proposed methodology for Seir radiation licensees would demonstrate rule would provide licensees with protection programs (i.e., the revised c mpliance with the dose limits in Part additional flexibility m conductmg and Part 20 methodology) and another 20 using the 1977 dose calculational submitting design basis accident methodology for their design basis metho,dology of ICRP-26 for their analyses to demonstrate compliance accident analyses, radiation protection programs as with the requirements in S 72.106(b). In This proposed rule does not revise required by SS 72.24(e) and 72.44(d). addition, the hcensees would no longer S 72.104(a) to incorporate ICRP-26 However, Part 72 licensees would need to comply with one calculational methodology because doing so would c ntinue t use the 1959 dose ,

methodology for their radiation render this regulation incompatible with calculational methodology of ICRP-2 in protection programs (i.e., the revised the Environmental Protection Agency s addressing radiation dose from a design Part 20 methodology) and another regulation at 40 CFR 191.03(a) which is basis accident as required in S 72.106(b). methodology for their design basis applicable to ISFSI and MRS licensees. Thus, licensees would not be able to accident analyses.

flowever,40 CFR 191.03(a) phrases the e of the ficxibility The proposed rule,if adopted, would standard in terms of dose limits to the take provided advantafhe by cose calculational not impose any additional obligations whole body and any critical organ; methodology med in Part 20 when on entities that may fall within the whereas. S 72.104(a) phrases th" performing aesign basis accident definition of"small entities" as set forth standard in terms of dos.e hmits to the analyses Therefore, this alternative was in Section 601(3) of the Regulatory whole body and any organ. The NRC not pursued. Flexibility Act; or within the defm' ition staff proposes to make S 72.104(a) more 2. Amendments of 10 CFR Part 72 of"small business" as found in Section consistent with 40 CFR 191.03(a) by 3 of the Small Business Act,15 U.S.C.

in this option, the NRC staff 632; or within the size standards inserting the word critical before the considered preparing a proposed rule to adopted by the NRC on April 11,1995 word organ. The entical organ (listed in amend the dose limiting design (60 FR 18344).

Table 1 ofICRP-2) associated with an objective in S 72.106(b) to 5 rem TEDE.

intake of radioactive material is This is consistent with the intent of the Backfit Analys.is considered to be that organ of the body existing 5 72.106(b) and updates the whose damage by the radiation restits The NRC has determined that the dose calculational methodology to that backfit rule,10 CFR 72.62, does not in the greatest damage to the body. used for demonstration of compliance apply to this proposed rule, and a EnvironmentalImpact: Categorical with Part 20. Updating the dose backfit analysis is not required because Exclusion calculational methodology also would these amendments do not involve any increase the organ dose limit, CDE, from provisions that would impose backfits The NRC has determined that this 5 rem to 50 rem: allow for the use of as defined in 10 CFR 72.62(a). The rule proposed regulation is the type of action risk-based weighting factors for each does not constitute a backfit under 10 described in categorical exclusion 10 organ or tissue to determine the 50 year CFR 72.62, because it does not require CFR 51.22(c)(2). Therefore neither an CEDE; and provide licensees with environmentalimpa-t statement nor an a change to existing structures, systems, additional flexibility in conducting and components, procedures, or environmental assessment have been submitting design basis accident organization. Further, the rule would prepared for this proposed regulation. analyses to demonstrate compliance not result in a more stringent outcome Paperwork Reduction Act Statement ,

with the requirements in S 72.106(b). thca the existing rule, and therefore in addition to the increased flexibility current licensees who are m compliance This proposed rule does not contain provided, licensees would no longer a new 7r mWI 4, formation with the existing rule would not be need to comply with one calculational required to make any changes or take collect'un rPyuiremtHt, and therefore is methodology for radiation protection any action. New apphcants and license not subject to requin ments of the programs (i.e., the revised Part 20 renewal applications would be able to P pwwork ReducGon Act of 1995 (44 methodology) and another methodology take advantage of some additional U.S.C. 3501 et ,eq.). Existing for design basis accident analyses. flexibility in the dose calculations that information collection requirements Moreover, design basis accident is afforded by the rule.

were approved by the Office of analyses for ISFSis and MRS Management and Budget, approval mstallations would use the same dose numbers 3150-0002, 3150-0127, and calculational methodology as design Under the " Policy Statement on 3150-0132, basis accident analyses for a geologic Adequacy and Compatibility of i

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13374 Fedir:1 Registir/Vol. 63, No. 53 / Thursday, March 19,1998/ Proposed Rules Agreement State Programs" approved by $ 72.104 [ Amended)

SUMMARY

This document proposes to  !

the Commission on June 30,1997 (62 FR 2. In S 72.104, the introductory text of adopt a new airworthiness directive 46517), this rule is classified as paragraph (a)is revised to read as (AD) that would apply to all Cessna compatibility Category "NRC." This follows Aircraft Company (Cessna) 180,182, l regulation addresses areas of exclusive and 185 series airplanes equipped with NRC authority. liowever, a State may $ 72.104 Crueda tw radioactive materials w ng extension supplemental type tdopt these provisions for the purposes l"SF RS certificate (STC) SA00276NY. The ,

of clarity and communication, as long as proposed action would require I the Stato does not adopt regulations or (a) During normal operations and u n inspecting between wing station (W.S.) I program elements that would cause the {1cipa\e bi, 90 and W.S.110 for an angle stiffener State to regulate this area. , 9q y ny who is located beyond the controlled at the lower wing spar splice. If the angle stiffener is not installed, the i; List of Subjects in 10 CFRPart 72 area must not exceed 25 mrem to the Proposed action would require Criminal penalties Manpower whole body,75 mrem to the thyroid and installing a reinforcing stra . The  ;

25 mrem to any other critical organ as training programs, Nuclear materials, a result of exposure to. Proposed action is the resu t of failed Occupational safety and health, , , , , ', test results revealing that the wings of Reporting and recordkeeping . . these Cessna airplanes, without the requirements, Security measures, Spent to read 3. In Gas72.106, follows:paragraph (b) is revised stiffener, do not meet the applicable fuel. design requirements after being .

$ 72.106 Contmned area of an ISFSI w modified by the above STC. The actions l For the reasons set out in the MRS. sPecified by the proposed AD are preamble and under the authority of the . . . . . I tended to prevent wing failure during Atomic Energy Act of 1954, as amended- flight, which, if not corrected, could the Energy Reorganization Act of 1974* (b) Any individuallocated on or as amended; and 5 U.S.C. 553; the beyond the nearest boundary of the cause loss of control of the airplane.

c ntrolled area may not receive from DATES: Comments must be received on Commission is proposing to adopt the or before May 15,1998.

following amendments to 10 CFR Part any design basis accident the more

,2' limiting of a total effective dose ADDRESSES: Submit comments in  !

l equivalent of 0.05 Sv (5 rem), or the sum triplicate to the Federal Aviation PART 72-LICENSING of the deep-dose equivalent and the Administration (FAA), Central Region. I REQUIREMENTS FOR THE committed dose equivalent to any Office of the Regional Counsel, i INDEPENDENT STORAGE OF SPENT individual organ or tissue (other than Attention: Rules Docket No. 97-CE l NUCLEAR FUEL AND HIGH-LEVEL the lens of the eye) of 0.5 Sv (50 *em). AD, Room 1558,601 E,12th Street, RADIOACTWE WASTE The eye dose equivalent shell not Kansas City, Missouri 64106. Comments exceed 0.15 Sv (15 rem) and the shailow may be inspected at this location

1. The authority citation for Part 72 dose equivalent to skin or to any between 8 a.m. and 4 p.m., Monday continues to read as follows: extremity shall not exceed 0.5 Sv (50 through Friday, holidays excepted.

Authority: Secs. 51,53,57,62,63,65,69, rem). The minimum distance from the Service information that applies to the 81,161,182,183.184,186.187,189,68 Stat. spent fuel or high-level radioactive proposed AD may be obtained from Air 229,930,932,933,934,935,948.953,954, waste handling and storage facilities to Research Technology, Inc.,3440 955, as amended, sec. 234,83 Stat. 444, as the nearest boundary of the controlled McCarthy, Montreal, Quebec, Canada ,

cmended (42 U.S.C. 2071,2073,2077,2092, area must be at least 100 meters. H4K 2P5; telephone (514) 337-7588:

2093,2095,2099,2111,2201,2232,2233, . . . . . facsimile (514) 337-3293. This 2234, 2236, 2237,2238, 2282); sec. 274, Pub. Dated at Rockville, Maryland, this 3rd day information also may be examined at L 86-373,73 Stat. 688, as amended (42 of March 1998, the Rules Docket at the address above i r the Nuclear Regulatory Commission. FOR FURTHER INFORMAll0N CONTACT: 6 8 t 2, a ended 2 4,1246 4 U.S.C. 5841,5842. 5846) Pub. L 95-.601, sec. L Imph Callan, Maroof. Aerospace Engineer, New York 10,92 Stat. 2951 as amended by Pub. L 102- Executive Directorfor Opemtions. Aircraft Certificat on Office,10 Fifth 486, sec. 7902,106 Stat. 3123 (42 U.S C- (FR Doc. 98-7114 Filed 3-18-98,8.45 am) Street,3rd Floor, Valley Stream, New 5851); sec.102. Pub. L 91-190,83 Stat. 853 an.UNG CODE 7s90-4M York,11581-1200; telephone (516) 256-(42 U.S.C. 4332); secs.131,132,133,135. 7522; facsimile (516) 568-2716.

137,141, Pub. L 97-425,96 Stat. 2229,2230. SUPPLEMENTARY INFORMATION:

2232, 2241, sec.14 8, Pub. L.100-203,101 Stat.1330-235 (42 U.S C.10151,10152, DEPARTMENT OF TRANSPORTATION Comments invited ction 72 4 g) a so ssu d un e secs. Federal Aviation Administration nteres p ns in ited to 142(b) and 148(c). (d). Pub'. L. 100-203,101 P P 8 Stat.1330-232,1330-236 (42 U.S C. 14 CFR Part 39 Pmposed rule by submitting such 10162(b),10168(c). (d)). Section 72 46 also * "

[ Docket No. 97-CE-14-AD) they may desire. Communications issued under sec.189. 68 Stat. 955 (42 U.S C.

2239h sec.134. Pub. L 97-425. 96 Stat. 2230 RIN 2120-AA64 should identify the Rules Docket (42 U.S C.10154). Section 72 96(d) also number and be submitted in triplicate to issued under sec.145(g), Pub. L 100-203, Airworthiness Directives; Cessna the address specified above. All 101 Stat.1334-235 (42 U.S.C.10165(g)). Aircraft Company 180,182, and 185 communications received on or before Subpart ] also assued under secs. 212). 2(15). Series Airplanes the closing date for comments, specified AGENCY: Federal Aviation above, will be considered before taking 2 0 .'220 2204, 2 22 4 4 t S C.

10101,10137(a),10161[h)). Subparts K and L Administration DOT. action on the proposed rule. The are also issued under sec.133. 98 Stat 2230 pmp s is c ntamed in this notice may ACTION: Notice of proposed rulemaking

(.2 tLS C.10153) and sec. 218(a). 96 Stat. (spgyj, be changed in light of the comments 2252 (42 U.S.C.101981 received.

J .D E < t DCD 8 % W n ,3 00CKETED b l[d PROPOSECf w rn 7A "cFRC %g,

[7590-01 P]

(43 FR 133 74)

W MAR 19 P1 :47 NUCLEAR REGULATORY COMMISSION OF= - -

10 CFR Part 72 RUl~.

ADJL J' eF RIN: 3150-AF84 i Minor Revision of Design Basis Accident Dose Limits for Independent Spent Fuel Storage and Monitored Retrievable Storage Installations I

AGENCY: Nuclear Regulatory Commission.

ACTION: Proposed rule. l

SUMMARY

The Nuclear Regulatory Commission (NRC) proposes to amend its regulations goveming the dose limits and the dose calculational methodology used in design basis accident l

analyses for Independent Spent Fuel Storage installations (ISFSI) and Monitored Retrievable Storage Installations (MRS). This proposed rule would amend ISFSI and MRS design basis accident dose limits to conform to the dose calculational methodology currently used in the regulations that specify standards for protection against radiation and make a minor change to match the Environmental Protection Agency's (EPA) regulations. This action is needed to make limits for design basis accidents at IDFSI and MRS installations consistent with dose l

methodology specified in the regulations, and to afford licensees the flexibility provided by dose methodology when performing design basis accident analyses.

j My f 111[f l DATES: The comment period expires (45 dri; ier J.6 vi 47.c;;;; . b L T;27;l Zs'.Cr.)

Comments received after this date will be considered if it is practical to do so, but the Commission is able to assure consideration only for comments received on or before this date.

I fpb. On 3fI9!9Y 91os2 G +03 op

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ADDRESSES: Mailwritten comments to: Secretary, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001. Attention: Rulemakings and Adjudications Staff. Comments may

> be delivered to One White Flint North,11555 Rockville Pike, Rockville, MD 20852, between 7:30 j am and 4:15 pm on Federal workdays.

You may also provide comments via the NRC's interactive rulemaking web site through the NRC home page (http://www.nrc. gov). This site provides the availability to upload comments as files (any format) if your web browser supports that function. For information about the interactive rulemaking site, contact Ms. Carol Gallagher, (301) 415-6215; e-mail CAG@nrc. gov.

Certain documents related to this rulemaking, including comments received, may be examined at the NRC Public Document Room,2120 L Street NW., (Lower Level), Washington, DC. These same documents also may be viewed and downloaded electronically via the interactive rulemaking website established by NRC for this rulemaking.

FOR FURTHER INFORMATION CONTACT: Naiem S. Tanious, Office of Nuclear Material Safety and Safeguards, U.S Nuclear Regulatory Commission, Washington, DC 20555-0001, telephone (301) 415-6103, E-mail: INTERNET:NST@NRC. GOV SUPPLEMENTARY INFORMATION:

Background

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! Paragraph (b) of section 72.106 establishes the dose limit for a design basis accident at t

an independent spent fuel storage installation (ISFSI) or a monitored retrieval storage installation l

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y (MRS). The dose limit in S 72.106(b)is based on the dose calculational methodology contained in international Commission on Radiological Protection Publication Number 2 (ICRP-2,1959)

The ICRP-2 methodology was subsequen'.ly revised in ICRP Publication Number 26 (ICRP-26, 1977), and was incorporated into 10 CFR Part 20 when Part 20 was revised in 1991.

The calculational methodology in the revised Part 20 no longer quantifies dose in terms of whole body dose and individual organ dose. Instead, the dose is quantified as a risk equivalent dose. In this manner, the doses absorbed by the whole body and the individual organs can be summed to a single quantity relating to tisk.

Under the Part 20 calculational methodology, deep-dose equivalent (H3 ), which applies to I the extemal whole-body exposure, is defined at 10 CFR 20.1003 as the dose equivalent at a tissue depth of 1 cm (1000 mg/cm2). The committed dose equivalent (CDE) (Hr w) is defined at i

5 20.1003 to mean the dose equivalent to organs or tissues of reference (T) that will be received l 1

from an intake of radioactive material by an individual during the 50-year period following the intake. The committed effective dose equivalent (CEDE) (He w) is defined at S 20.1003 as the sum of the products of the weighting factors applicable to each of the body organs or tissues that are irradiated and the committed dose equivalent to these organs or tissues (Hg,w = Ew1 H 1,w).

The* total effective dose equivalent (TEDE) is the sum of the deep-dose equivalent (for extemal ,

exposure) and the committed effective dose equivalent (for internal exposures).

The ICRP-26 methodology was not incorporated into Part 72 at the time Part z0 was revised. Part 72 contains two regulations that specify dose limits: S 72.104, which sets dose limits during normal operations and anticipated occurrences; and S 72.106, which sets dose limits for design basis accidents.

The main objective of this proposed rule is to revise 72.106(b) to incorporate the methodology in 10 CFR Part 20. A second objective of the rule is to make a minor word change to S 72.104(a) to match the language used by EPA in 40 CFR 191.03(a).

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Discussion At present, S 72.106(b), Controlled area of an ISFSI or MRS provides:

l (b) Any individuallocated on or beyond the nearest bouridary of the controlled area shall not receive a dose greater than 5 rem to the whole body or any organ from any design basis accident. The minimum distance from the spent fuel or high-level radioactive waste handling and storage facilities to the nearest l

boundary of the controlled area shall be at least 100 meters.

l This 0.05 Sv (5 rem) limit to the whole body or any organ would be amended in the proposed rule to conform with the Part 20 dose calculational methodology. The amended limit would become the more limiting of the TEDE of 0.05 Sv (5 rem), or the sum of the deep dose l

equivalent and the committed dose equivalent to any individual organ or tissue (other than the lens of the eye) of 0.5 Sv (50 rem). The amendment would also include a separate dose limit for the lens of the eye of 0.15 Sv (15 rem); and for the skin or any extremity, a shallow dose equivalent of 0.5 Sv (50 rem). The use of separate dose limits for the eye, skin, and extremities would conform with the dose calculational methodology used in Part 20 and would ensure that no observable effects (e.g., is.Juction of cataracts in the lens of the eye) would occur as a result of any accidental radiation exposure.

This action would make S 72.106 consistent with Part 20 dose calculational methodology.

This action would also provide Part 72 licensees flexibility when performing design basis accident analyses because they would be able to use organ weighting factors to calculate the dose to the maximally exposed organ. In addition, Part 72 licensees would no longer need to comply with 4

I one calculationr' nethodology for their radiation protection programs (i.e., the revised Part 20 methodology) and another methodalogy for their design basis accident analyses.

This proposed rule does not revise $ 72.104(a) to incorporate ICRP-26 methodology because doing so would render this regulation incompatible with the Environmental Protection Agency's regulation at 40 CFR 191.03(a) which is applicable to ISFSI and MRS licensees.

However,40 CFR '.91.03(a) phrases the standard in terms of dose limits to the whole body and any cdtical osan; whereas, f 72.104(a) phrases the standard in terms of dose limits to the whole body and rty osan. The NRC staff proposes to make $ 72.104(a) more consistent with 40 CFR 191.03(a) by inserting the word cdtical before the word organ. The critical organ (listed in Table 1 cf ICRP-2) associated with an intake of radioactive material is considered to be that organ of the body whose damage by the radiation results in the greatest damage to the body.

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Environmentalimpact: Categorical Exclusion l 1

The NRC has determined that this proposed regulation is the type of action described in categorical exclusion 10 CFR 51.22(c)(2). Therefore neither an environmentalimpact statement nor an environmental assessment have been prepared for this proposed regulation.

Paperwork Reduction Act Statement This proposed rule does not contain a new or amended information collection requirement, and therefore is not subject to requirements of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.). Existing information collection requirements were approved by the Office of Management and Budget, approval numbers 3150-0002,3150-0127, and  !

3150-0132.

Public Protection Notification if an information collection does not display a currently valid OMB control number, the NRC may not conduct or sponsor, and a person is not required to respond to, the information collection.

Regulatory Analysis To determine whether the amendments to 10 CFR Part 72 are appropriate, the NRC staff considered the following two attematives:

1. The No-Action Alternative. This attemative is not acceptable to the NRC for the following reasons. Section 72.106(b) would continue to be inconsistent with Part 20. Part 72 6

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licensees would demonstrate compliance with the dose limits in Part 20 using the 1977 dose calculational methodology of ICRP-26 for their radiation protection programs as required by SS 72.24(e) and 72.44(d). However, Part 72 licensees would continue to use the 1959 dose calculational methodology of ICRP-2 in addressing radiation dose from a design basis accident as required in S 72.106(b). Thus, licensees would not be able to take advantage of the flexibility )

provided by the dose calculational methodology used in Part 20 when performing design basis accident analyses. Therefore, this altemative was not pursued.

2. Amendments of 10 CFR Part 72. In this option, the NRC staff considered preparing a proposed rule to amend the dose limiting design objective in 9 72.106(b) to 5 rem TEDE. This is consistent with the intent of the existing 9 72.106(b) and updates the dose calculational methodology to that used for demonstration of compliance with Part 20. Updating the dose 1

calculational methodology also would increase the organ dose limit, CDE, from 5 rem to 50 rem; allow for the use of risk-based weighting factors for each organ or tissue to determine the 50 year CEDE; and provide licensees with additional flexibility in conducting and submitting desigri basis accident analyses to demonstrate compliance with the requirements in S 72.106(b).

In addition to the increased flexibility provided, licensees would no longer need to comply with one calculational methodology for radiation protection programs (i.e., the revised Part 20 methodology) and another methodology for design basis accident analyses.

Moreover, design basis accident analyses for ISFSis and MRS installations would use the same dose calculational methodology as design basis accident analyses for a geologic repository operations area (10 CFR 60.136(b)). This altemative was chosen by the NRC.

This constitutes the regulatory analysis for this proposed rule. As discussed above, this rule does not impose any new requirements. Therefore, there will be no additional cost burden to Part 72 licensees or the Federal Govemment.

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b Regulatory Flexibility Certification As required by the Regulatory Flexibility Act of 1980,5 U.S.C. 605(b), the Commission certifies that this rule, if adopted, will not have a significant economic impact upon a substantial number of small entities. The proposed rule would provide licensees with additional flexibility in t conducting and submitting design basis accident analyses to demonstrate compliance with the requirements in 9 72.106(b). In addition, the licensees would no longer need to comply with one calculational methodology for their radiation protection programs (i.e., the revised Part 20 methodology) and another methodology for their design basis accident analyses.

The proposed rule, if adopted, would not impose any additional obligations on entities that may fall within the definition of "small entities" as set forth in Section 601(3) of the Regulatory Flexibi!ity Act; or within the definition of "small business" as found in Section 3 of the Small Business Act,15 U.S.C. 632; or within the size standards adopted by the NRC on April 11,1995 (60 FR 18344).

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Backfit Analysis l

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l The NRC has determined that the backfit rule,10 CFR 72.62, does not apply to this l

l proposed rule, and a backfit analysis is not required, because these amendments do not involve l

l any provisions that would impose backfits as defined in 10 CFR 72.62(a). The rule does not l

l constitute a backfit under 10 CFR 72.62, because it does not require a change to existing structures, systems, components, procedures, or organization. Further, the rule would not result in a more stringent outcome than the existing rule, and therefore current licensees who are in compliance with the existing rule would not be required to make any changes or take any action.

New applicants and license renewal applications would be able to take advantage of some additional flexibility in the dose calculations that is afforded by the rule.

Agreement State implementation issues Under the " Policy Statement on Adequacy and Compatibility of Agreement State Programs" approved by the Commission on June 30,1997 (62 FR 46517), this rule is classified as compatibility Category *NRC." This regulation addresses areas of exclusive NRC authority.

However, a State may adopt these provisions for the purposes of clarity and communication, as long as the State does not adopt regulations or program elements that would cause the State to regulate this area.

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List of Subjects in 10 CFR Part 72 '

Criminal penalties, Manpower training programs, Nuclear materials, Occupational safety and health, Reporting and recordkeeping requirements, Security measures, Spent fuel.

! For the reasons set out in the preamble and under the authonty of the Atomic Energy Act l

of 1954, as amended; the Energy Reorganization Act of 1974, as amended; and 5 U.S.C. 553; the Commission is proposing to adopt the following amendments to 10 CFR Part 72.

PART 72 - LICENSING REQUIREMENTS FOR THE INDEPENDENT STORAGE OF SPENT NUCLEAR FUEL AND HIGH-LEVEL RADIOACTIVE WASTE j

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1. The authority citation for Part 72 continues to read as follows:

1 AUTHORITY: Secs. 51,53,57,62,63,65,69,81,161,182,183,184,186,187,189,68 Stat. 929, 930, 932, 933, 934, 935, 948, 953, 954, 955, as amended, sec. 234,83 Stat. 444, as l amended (42 U.S.C. 2071, 2073, 2077, 2092, 2093, 2095, 2099, 2111, 2201, 2232, 2233, 2234, i

2236,2237,2238,2282); sec. 274, Pub. L.86-373,73 Stat. 688, as amended (42 U.S.C. 2021);

sec. 201, as amended, 202,206,88 Stat.1242, as amended, 1244,1246 (42 U.S.C. 5841, 5842, l

5846); Pub. L.95-601, sec.10,92 Stat. 2951 as amended by Pub. L. 102-486, sec. 7902,106 Stat. 3123 (42 U.S.C. 5851); sec.102, Pub. L. 91 190, 83 Stat. 853 (42 U.S.C. 4332); secs.131, 132,133,135,137,141, Pub. L.97-425,96 Stat. 2229,2230,2232,2241, sec.148, Pub. L.100-203,101 Stat.1330-235 (42 U.S.C.10151,10152,10153,10155,10157,10161,10168).  !

Section 72.44(g) also issued under secs.142(b) and 148(c), (d), Pub. L. 100-203,101 Stat.1330-232,1330-236 (42 U.S.C.10162(b),10168(c), (d)). Section 72.46 also issued under i

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sec.189,68 Stat. 955 (42 U.S.C. 2239); sec.134 Pub. L.97-425,96 Stat. 2230 (42 U.S.C.

10154). Section 72.96(d) also issued under sec.145(g), Pub. L.100-203,101 Stat.1330-235 (42 U.S.C.10165(g)). Subpart J also issued under secs. 2(2),2(15),2(19),117(a),141(h), Pub.

L.97-425,96 Stat. 2202,2203,2204,2222,2224 (42 U.S.C.10101,10137(a),10161(h)).

Subparts K and L are also issued under sec.133,98 Stat. 2230 (42 U.S.C.10153) and sec. 218(a),96 Stat. 2252 (42 U.S.C.10198).

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$ 72.104 [ Amended] , j

2. In 9 72.104, the introductory sentence of paragraph (a)is revised to read as follows:

6 72 104 Criteria for radioactive materials in effluents and direct radiation from an ISFSI or MRS.

(a) During normal operations and anticipated occurrences, the annual dose equivalent to l any realindividual who is located beyond the controlled area must not exceed 25 mrem to the whole body,75 mrem to the thyroid and 25 mrtm to any other critical organ as a result of l

exposure to:

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3. In S 72.106, paragraph (b)is revised to read as follows: 5P iqq 1,/

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6 72 106 Controlled area of an ISFSI or MRS.

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. (b) Any individuallocated on or beyond the nearest boundary of the controlled areah" I

not receive from any design basis accident the more limiting of a total effective dose equivalent of 0.05 Sv (5 rem), or the sum of the deep-dose equivalent and the committed dose equivalent to any individual organ or tissue (other than the lens of the eye) of 0.5 Sv (50 rem).

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lC i-S The eye dose equivalent shall not exceed 0.15 Sv (15 rem) and the shallow dose equivalent to skin or to any extremity shall not exceed 0.5 Sv (50 rem). The minimum distance from the spent fuel or high-level radioactive waste handling and storage facilities to the nearest bounda mv# g o1 of the controlled area at least 100 meters. g gjf't!-

p c. '"

Dated at Rockville, Maryland, this' 3 day of M g 1998.

For the Nuclear Regulatory Commission.

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i L. Joseph (allan, Executive Dwetor for Operations.

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