ML20153E746

Requests Commission Approval by Negative Consent for Staff to Partially Fund Natl Academy of Science/Natl Research Council Grant to Fund Biological Effects of Ionization Radiation Study Number VII (Beir VII)

ML20153E746
Person / Time
Issue date:	09/01/1998
From:	Callan L NRC OFFICE OF THE EXECUTIVE DIRECTOR FOR OPERATIONS (EDO)
To:
References
SECY-98-206, SECY-98-206-01, SECY-98-206-1, SECY-98-206-R, NUDOCS 9809280230
Download: ML20153E746 (51)

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POLICY ISSUE Scotember 1.1998 SECY-98-206 EQB: The Commissioners FROM L. Joseph Callan Executive Director for Operations SUBJECT. NATIONAL ACADEMY OF SCIENCES / NATIONAL RESEARCH COUNCIL GRANT TO FUND THE BIOLOGICAL EFFECTS OF IONIZATION RADIATION STUDY NUMBER Vil (BEIR Vil)

PURPOSE:

To request Commission approval by negative consent for the staff to partially fund the subject grant proposal (Attachment 1).

BACKGROUND:

The staff forwarded SECY-95-249, dated October 3,1995, containing a joint Nuclear Regulatory Commission / Environmental Protection Agency (EPA) " White Paper on Risk Harmonization" and " Risk Harmonization Recommendations of the interagency Steering Committee on Radiation Standards" (ISCORS). General Risk Management Recommendation

1. 3 proposed the initiation of a comprehensive review of the risk associated with ionizing radiation by the National Academy of Sciences / National Research Council (NAS) as Committee Vil of the Biological Effects of lonizing Radiation (BEIR Vil). The staff estimated that NRC's portion of the BEIR Vil funding would be $100,000 per year for 3 years and 0.5 full-time equivalent per year for 3 years. -

y in a Staff Requirements Memorandum, dated November 29,1995, the Commission approved the joint NRC/ EPA Recommendatior;s on Risk Harmonization, and directed the staff to " provide 7

gg the Commission with an explanation of how the results of the BEIR Vil study will be factored into Wf 7 the risk harmonization effort, and in particular, into the schedule for the issuance or reconsideration of any Federal Guidance document." The staff response to the Commission, dated March 11,1996, indicated that the BEIR Vil report could have a variety of implications for Federal guidance on radiation protection. For example, it could affect the recommended annual dose limit for members of the general public (currently 100 mrem per year), or it could affect the

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. l The Commission 2 recommendation that doses from individual sources be limited to a fraction of the public dose limit.

In a Staff Requirements Memorandum, dated April 2,1996, the Commission approved the staff's recommendation to proceed with BEIR Vil as expeditiously as the availability of financial resources and new scientific information will permit, and directed the staff, on completion of BEIR Vll, to " provide recommendations to the Commission regarding the implications of BEIR Vil for NRC regulations, for Federal guidance, and for risk harmonization."

A task group from the ISCORS Risk Harmonization subcommittee (EPA, DOE, and NRC) jointly drafted the BEIR Vil work scope with two phases. This work scope became the basis on which the NAS prepared their project proposal to establish a committee to reassess the health risks '

related to exposure to low-level ionizing radiation. In the first phase, the committee would collect and evaluate data published since the 1990 BEIR V report to determine whether sufficient new information is available to warrant a comprehensive reassessment of health risks related to low-level radiation exposure and define the most productive scope, goals and objectives for the comprehensive reassessment (phase 2). The NAS proposal was reviewed and approved by the ISCORS task group members. EPA awarded a $230K grant to NAS to initiate a 12 month feasibility study (phase 1) beginning in September 1996.

The BEIR Vil phase-1 committee convened its first meeting, March 26,1997, to reassess the health risks related to exposure to low-level ionizing radiation. The committee evaluated the l scientific literature pertinent to the biologic and health effects of low-level ionizing radiation and convened a scientific workshop, July 21-22,1997, to assess the impact of biology on risk l

t assessment. Based on their review, the committee submitted to the EPA a letter report, dated January 21,1998, that stated that sufficient information has become available since the 1990 BEIR V report to warrant a comprehensive reassessment of health risks in a BEIR Vil phase-2 study. The committee recommended issues that could be addressed in a BEIR Vil study,

provided justification for those recommendations, listed primary sources of data that might be

used, assessed whether a detailed analysis of particular issues could have a significant effect l on radiation risk estimates, and indicated what scientific disciplines should be represented in order for a committee to address the key issues adequately in a phase-2 study. The committee's recommendations are discussed in greater detail in a report entitled Health Effects of Exposure to Low Levels ofIonizing Radiation

Time for Reassessment? (Attachment 2).

EPA forwarded to NRC, DOE, and DOD a draft proposal for the BEIR Vil phase-2 study on May l 27,1998. NRC comments were provided to NAS on June 9,1998. The final NAS proposal is to establish a committee of approximately 15 persons to: conduct a comprehensive review of relevant epidemiologic data related to risk from exposure to low-doses of low-LET radiation, define and establish principles on which quantitative epidemiological analyses can be based, assess the current status and relevance to risk inodels of biologic data and models of i

carcinogenesis, consider problems that might exist in determining doses to target cells, and l consider recent evidence regarding genetic effects not related to cancer. A major goal of the BEIR Vil phase-2 study will be to better quantify and characterize the uncertainties associated with risk estimates and to produce the most realistic estimates of uncertainties. The committee will produce a consensus report that contains conclusions and recommendations regarding the health risks related to exposure to ionizing radiation.

__ - _ _ - . _ . _ _ _ . _ _ _ . - ~ _ _ _ . _ . _ _ . _ . _ . - _ . _ _ - - . _ _ _

The Commission 3 DISCUSSION:

The BEIR Vil phase-1 committee concluded that sufficient information has become available since publication of the BEIR V in 1990 that makes this an " opportune time" to proceed with BEIR Vil phase-2. For example, information published since the BEIR V report has prompted renewed questioning of the postulated linear nonthreshold dose-response relationship at low levels of exposure such as natural background or very small incremental doses above natural background. This dose response relationship has provided the scientific basis on which federal agencies have developed regulatory standards and advisory recommendations for over thirty years. The BEIR Vil study, in part, will be aimed at updating the assessment of risks related to low-dose, low-LET radiation and exploring all that is known regarding the biologic processes -

determining those risks. Furthermore, the results of the BEIR Vil study may enat,le NRC and EPA to bridge several risk management differences that might not otherwise be resolved without the NAS' independent scientific review.

l One disadvantage of initiating phase-2 now is that several potentially important studies may not '

be completed in time to be fully considered by the BEIR Vil committee. For example, the NAS recently reactivated its Committee on Dosimetry to review and possibly revise DS80, the dosimetry system on which individual doses for the Japanece atomic-bomb survivors and current cancer mortality risk estimates are based. Although the results of the reevaluation will not be available for several years, revision of the dosimetry system could significantly change

- the current risk coefficients for fatal cancer. The NAS staff for BEIR Vil recognize the potential l implications of a revised DS86 dosimetry system and are willing to delay publication of the final l BEIR Vil report if such a delay is warranted.

l The NRC staff believe the NAS proposal is responsive to the NRC's desire to initiate a comprehensive review of the health effects associated with exposure to low-dose, low-dose rate ionizing radiation and to obtain realistic risk estimates for carcinogenic and noncarcinogenic health effects. NRC staff and other members of the BEIR Vil task group also  ;

l recognize that additional health effects data and a more complete understanding of the cellular I and molecular response to radiation exposure may be acquired in the next few years.

However, it may be beneficial to at least evaluate the information that is available since ,

publication of BEIR V eight years ago, and we may gain useful information from an NAS review l of these publications. Therefore, Mr. Dennis O'Connor announced at the June 1998 ISCORS meeting that EPA plans to award a grant to NAS during FY 98 to initiate the BEIR Vil phase-2 study. Since the BEIR Vil phabe-2 study could prompt EPA to move forward on finalizing Federal Guidance on exposure of the general public, the staff believes it is prudent for NRC to co-fund the BEIR Vil study to ensure that the Commission's concems are adequately addressed by the NAS committee.

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NATIONAL RESEARCH COUNCIL COMMISSION ON LIFE SCIENCES I-2101 Consutution Avenue Washington D.C. 20l18 Telephone: (202) 334-2500; Facsimile: (202) 334-1639 June 16,1998 RE: NAS Proposal No. 98-CLG-271-01 Mr. Lawrence Weinstock Acting Director, Radiation Protection Division Office of Radiation and Indoor Air Environmental Protection Agency Washington,DC 20460

Dear Mr. Weinstock:

la response to your letter of June 5,1998, we are pleased to submit a proposal entitled " Health Risks From Exposure to Low Levels ofIonizing Radiation (BEIR Vil - Phase-2)." This proposal was prepared by the Board on Radiation Effects Research, Commission on Life Sciences The total estimated cost of this project is $1,195,000 for the period from September 1,1998 to August 31,20v s.

A small multidisciplinary committee of 8 members formed in 1996 conducted a phase i scoping study and determined that it is appropriate and feasible to conduct a re.messment of the health risks based on a review of the j studies which have been published since BEIR V_in 1990. The committee's recommendations were summarized in l

a letter report sent to EPA in January,1998. Those recommendations are justified in greater detail in a report titled

l. Health Effects ofExposure to Low Levels oflonizing Radiatwrr Timefor Reassessme' nt? The phase-1 stuoy defined the most productive scope for an enlarged phase-2 commmee and identified realistic goals and objectives for a phase 2 study which would result in a published report HHR \ 11 Preliminary discussions conceming the phase-2 study have been held with Dr. Jerome Puskin of > our ollice.

The responsible staff officer for this study is Dr. R. F. (Rick) Jostes, Senior Program Officer, Board on '

l, Radiation Effects Research. He can be reached at (202) 334-2232. Negotiations are the responsibility of l

Mr. Charles E. Arbanas, Senior Contract Manager, Office cf Contracts and Grants. He can be reached at (202) 334-2888.

We shall appreciate your consideration of this matter.

Sincerely, s

I

/) aul Gilman, Ph.D.

Executive Director Enclosures cc: Dr. Jerome Puskin i

l j 1he National Research Councilis the principal operatsng agency of the National Academy of Sciences and the National Acadenn of Engineenng

l. - to serve government and other orgam:ations

NATIONAL ACADEMY OF SCIENCES / NATIONAL ACADEMY OF ENGINEERING / ,

INSTITUTE OF MEDICINE / NATIONAL RESEARCH COUNCIL COMMISSION ON LIFE SCIENCES BOARD ON RADIATION EFFECTS RESEARCH Proposal No. 98-CLS-271-01 HEALTH RISKS FROM EXPOSURE TO LOW LEVELS OF IONIZING RADIATION (BEIR VII- PHASE-2) ,_

JUNE 1998 u

David P. Westbrpk R. F. (RTd) Jostes Manager, Federal Contracts Senior Program Officer Office of Contracts and Grants Board on Radiation Effects Research National Academy of Sciences Conunission on Life Sciences Telephone:(202) 334-2254 Telephone:(202) 334-2232 E-mail: dwestbrk@nas.edu E-mail: RJostes@nas.edu 44nuaiiv

[ E. William Colglazier Executive Officer National Academy of Sciences he Academy complex consists of four organizations: the National Academy of Sciences, the National Academy of Engineering, the Institute of Medicine, and the National Research Council. The National Research Council is the principal operating agency of the National Academy of Sciences and the National Academy of Engineering. This proposal is submitted by the National Academy of Sciences (NAS), which assumes full technical and legal responsibility under its Act ofIncorporation for the work to be carried out under any resultant agreement. We are a nonprofit publicly supported organization exempt from federal income tax under Intemal Revenue Service Code section 501(C)(3). The Taxpayer Identification Number is 53-0196932. Awards should be made payable to:

National Academy of Sciences Accounting Office  ;

ATTN: Cash Management Section 1 2101 Constitution Avenue, N.W.

Washington, DC 20418  ;

Telephone: 202-334-3541

UNITED STATES ENVIRONMENVAL PROTECVION AGENCY

• WASHINGTON. DC 20460 Fo<m Approved

1. h oM8 Wo 2000.o453 fp PROCUREMENT SYSTEM CERTIFICATION Acorovei ...<.. io-ai 87 APPUCANT'S NAME ASSISTANCE APPUCATION NUMBER NAS Proposal No. 98-CLS-271-01 NATIONAL ACADEMY OF SCIENCES APPUCANT'S ADDRESS l 2kO1COnstitutionAve.,NW, Washington,DC20418 l

l l

l l S ECTION I - lNSTRUCTIONS The applicant must complete and submit a copy of this form with each application for EPA Assistance. If the applicant has certified its procurement system to EPA within the past 2 years and the system has not been substantially revised, complete Part A in Section ll, then sign and date the form. lf the system has not been certified within the past 2 years, complete Part B then sign and date the form.

SECTION 11- CERTIFICATION A. I af firm that the apphcant has within the past 2 years certified to EPA that its procurement MONMEAR i

system complies with 40 CFR Part 33 and that the system meets the requirements in 40 CFR Part 33 The date of the applicant's latest certification is:

B. Based upon my evalJation of the applicant's procurement system, l as authorized representative of the ,

applicant:(Check one of the following:)

E 1. CERTIFV that the applicant's procurement system will meet all of the requirements of 40 CFR Part 33 before undertaking any procuremeat action wit" ED

• ass: stance PlGase f urnish Citations to apDlicable prDCurement ordinancel and regulatecnt l

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L_) 2 DO IVOT CERTIFY THE APPLICANT'S PROCUREMENT SYSTEM. The appucant agrees to f obow the re.cairements of 40 CFR Part 33, including the procedures in Appendix A. and TYPE D N A?'. ., 'I L GNATURE ,

)M David P. h'estbroOk , ttinager ,

Federal Cont racts / t ,

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OMB ApprovalNo 0348 @ 43 2 Das submed Appi. cant w6er APPLICATION FOR '

, , , , n mnn NAS MOP. NO. 984LS-N141 FEDERAL ASSISTANCE

l. Type of Submason- 3 DateM byIted lCUU State Appicanonident:6er Awmeean neewcason Constnzbon Constructon 4 Date Recewed by Federal Agency Federalident6er a Non4cnstruccon Non4anstruccon 5 Apphoent ./ .. -

LepelName . National Academy of Sciences Organaationot une National Research Council COMMISSION ON LIFE SCIENCES ,

Address (ow ce, cow +. asele, ew eved.J: Name and telephone number of 94 person to De contacted on meGert NwoMng eus e(ow eres woo) 2101 Constitution A'. or.u1 NW Charles E. Arbanas -

Washington, D.C. 20413 Contract Manager, Office of Contracts and Grants 202 334-2888

s. Empseyeridenshooton Number (Em). 7. Type of Apphoent (enter appropnete leser in en box)

H. Independent School Dist

[

53 019 6932 A State B. County i Siete Controlled insaluton of Higher Leemme 4 Type of a&~L C. Munopel J PrweteUnrversey I New Congnumeon Rownsen D. Township K. Ind.an T ribe E. Interste. L in'vidual d mouissen. enser appropnmes immere(s) in bou(est F. Intennunapel M. Pront Orgensaton

o. special Dietnct N Orwr(Specnyt Non-profit research A Increase Amerd B. Decrosse /merd C. Inorense Ourobon

- D.DecreaseDuremon Olher (speelfy)- 9 Name of Feders: A0ency Environmental Protection Agency 11 Desenptwo Tee of Apphoenfs Prmect

10. Cassieg of Federal Domente l l ll l l Asesmeace Numbr Health Risks From Exposure to Low Levels of lonizing Radiation (BEIR Vil), Phase-2 Title

12. Areas Afected by Propect (citos, countses, states, etc.)

N/A 13 Proposed Protect 14 CongressionalDistncts of Stan Date Ending Date e Appleant b. Project DC-at-large DC-at-large 9/1/98 8/31/01 16 IS APPuCATION &JBJECT TO REVIEW Bf STAT E EXECUTIVE ORDER 12372 PROCEW l SS. SSTIMATED FUNotNG a YES THIS PREAPPLICATIONMPPLICATION WAS MADE AVAILABLE TO THE L

L Federal (A0ency e eisek e) $1,195,000 STATE EXECUTIVE ORDER 12372 PROCESS FOR REVIEW ON.

b. Apamaant Date c Shite b NO PROGRAM IS NOT COVERED BY E O 12372 d Leont OR PROGRAM HAS NOT BEEN SELECTED BY STATE FOR REVIEW 3 Other Federal To be determined

f. Program income 17. 8S THE APPLICANT DELINQUENT ON ANY FEDERAL DEBT 1 g Tetel yes !!'Yes? ettach en explanabon 1 No

$1.195,000

18. To eie best of my knowledge and belief, au data in this oppi cabon/preappleabon are true and correct, the document has been duty ruptortred by the governing body of the applicant and the applicahon will comply with the attached assurances if the assistance is awarded.

e Typed Name of Authorued Representatwo b Title c ".elephone Number

{

O!vid P. Westbrook \ Manager, Feaeral Contracts 202-334-2lt54 d oen o,-o.R

,es.rg s JUN N'*m '

e_ u_s _ > ,_ e ,or. . .. - ,

OMB Approval No. 0348-0044 . .

BUDGET INFORMATION - Nontonst uctifon Programs Section A- Budget Summ:ry Grant Program Catalog of Federal Estimated Unobligated Funds New or Revised Budget Function Domestic Assistance or Activity Number Federal Non-Federal Federal Other Federal Total (a) (b) (c) (d) (e) (f) (g) r riealtn Misks trom txposure to Low Levels cf lonizing Radiation (BEIR Vil), Phase-2 $376,395 $0 $376,395 i Totals $ 378.395 $0 $376,395 Section B - Budget Categories Grant l'rogram I uncti n of Activity Total

> Objtet Class Categories (1) (2) __11) _

(4) (5) a versonnei

$305,811 $305,811 o Pringe uenents

$85,322 $85,322

c. travei

$286,54F $286,545

c. t:quipment

e. dupplies

$3,600 $3,600 i contractual 9 construcaon n utner

$83,433 $83,433 e ietai virect Unarges

$764,711 $764,711 j inairect unarges vetans on reverse

$430,289 $430,289 '

k. iotais (sum or os ena bj)

$1,195,000 $1,195,000

.#:.,: . 2 ~wmm _ ymen S. . ,ggagg$mmew. , ggypqgi; gygggg g. .gg .

Program income

SECTION C - Non-Federal Resources

(;) Grant Program (b) Applicant (c)Stata (d) Other Sources (7) Tctils 8.

$0 $0 9.

10.

11.

12. Totals (sum of lines 8 and 11) $0 $0 SECTION D - Forecasted Cash Needs Total for 1st year 1st Quarter 2nd Quarter 3rd Quarter 4th Quarter

13. Federal

$376,395 $94,099 $94,099 $94,099 $94,099

14. Nonfederal

15. Total (sum of lines 13 and 14)

$376,395 $94,099 $94,099 $94,099 $94,099 SECTION E- Budget Estimates of Federal Funds Needed for Balance of Project (a) Grant Program Future Funding Periods (years)

(b)First (c)Second (d) Third (e) Fourth 16.

$385,561 $433,044 $0 $0 17.

13.

19.

20. Totals (sum of lines 16-19) '

$385,561 $433,044 $0 $0 SECTION F - Other Budget Informaton (attach additional sheets if necessaty)

21. Direct Charges: $764,711 22 Indirect Charges: $430,289 OH, On-site is 61.9%; OH, Off-site is 34.1% Subcontract / Flow-thru Admin. is 2%; Regular G&A is 18.7%.

23. Remarks: See budget explanation pages.

sR 424A (4-88) Page 2

- . - . - - . -.--._..-_-._._..m -m. --~~~.-m.___. _ _ _ _ - . ___-

9 OM8 Apptoval No.034s.co4o ASSURANCES - NON-CONSTRUCTION PROGRAMS

~kste:

Certain of these assurances may not be applicable to your project or program. If you have qu

please contact the awarding agency. Further,certain Federal awarding agencies may require a ,

2 to certify to additional assurances ifsuch is the case you will be notified.

As the duly autho'rized representative of the applicant I certify that the applicant: '

, 1. Has the legal authority to apply for Federal '

(e)the Drug Abuse Office and Treatment Act of  !

cssistance, and the institutional, managerial and financial capability (including funds sufficient to 1972 (P.L.92-255), as amended, relating to nondiscrimination on the basis of drug abuse;,(f) pay the non Federal share of project costs) to

' the Comprehensive Alcohol Abuse and Alcoholism

' casure proper planning,' management and com. i Prevention, Treatment and Rehabilitation Act of  !

pletion of the project described in this application.

1970 (P.L. 91616), ~as amended, relating to-  !

2.

Will give the awarding agency

• the Comptroller n ndiscrimination on the basis of alcohol abuse or General of the United States, and if appropriate a m@H nd 52Me N Health 1 the State, through any authorised representative, Sen e Actof1912 H2 U.SE. 2Md 3 and th Access to and the right to examine all records, , as amended, reladng to conndendality of j bookt, papers, or documents related to the award; alcohol and drug abuse patient records; (h) Title gnd will e' stablish a proper accounting system in VIII of the Civil Rights Act of 1968 (42,U.S.C. I a

cecordance with generally accepted accounting 3601 et seqJ, as amended, reladng to non.

, i ste.ndards or agencydirectives. . disuuninabn in y sak, rental w Anandnd housing; (1) any other nondiscrimination,

3. Wtil establish safeguards to prohibit employees provisions in the specific statute (s) under which fMm using their positions for a purpose that application for Federal assistance is being made; cinstitutes or presents the appearance of personal . and (j) the requirements of any other

- cr crgsnizr.tional conflict of interest, or personal nondiscrimination statute (s) which may apply to yr.in. the application. ,

1.Will initiate and complete the work within the 7. Will comply, or has already complied, with the applicable time frame after receipt of approval of require'ments of Titles !! and !!! of the Uniform i the cwarding ager.cy Relocation Assistance and Real Property u Will comply with the Intergovernmental Acquisition Policies Act of 1970 (P.L. 91646)

Personnel Act of 1970 (42 U.S.C. !! 4728 4763) which provide for fair and equitable treatment of relating to prescribed standa rds for merit systems persons displaced or whose property is acquired as

' for programs funded under one of the ntneteen a result of Federal or federally assisted programs.

statutes or regulations specified in Appendix A of These requirements apply to all interests in real - '

s

. OPM s Standards for a Merit System of Personnel property acquired for project purposes regardless Administration (5 C.F.R. 900, Subpart F). of Federal participation in purchases.

1. Will comply w.dh all' Federal statutes relating t . 8. Will comply with the provisions of the Hatch Act nondiscrimination. These include but are not (5 U.S.C. Il 1501 1508 and 7324 7328) which limit limited to: (a) Title. VI of the Civil Rights Act of the political activities of ' employees whose 1964 (P.L. 88 352) which prohibits discrimination principal employment activities are funded. In cn the basis of race, color or national origin; (b) whole orin part with Federal funds.

Title IX of the Education Amendments of 1972, as 9. Will comply, as applicable, with the provisions of amended (20 U.S.C. Il 1681 1683, and 16851686), the Davis-Bacon Act (40 U.S.C. Il 276a to 276a.

whleh prohibits discrimination on the basis of sex; 7), the Copeland Act (40 U.S.C. i 276c and 18 (c) Section 504 of the Rehabilitation Act of 1973, as U.S.C. 66 874), and the Contract Work Hours and cmended (29 U.S.C I 794), which prohibits dis. Safety Standards Act (40 U.S.C. Il 327 333),

criminatio.n on the basis of handicaps;(d) the Age regarding labor standards for federally assisted

Discrimination Act of 1975, as amended (42 construction subagreements U S C ll 61016107), which prohibits discrim.

ination on the basis of age; swo% me o em Peev eetmM by OS/H Ca.f utta A 10?

Authorized for Local Reproduction

l

10. Will comply, if cpplicable, with nood insurance 13. Will assist the awarding agency in assurin purch:se r4quirements of Section M2(a) of the compliance with Section 106 of the Nationa '

Flood Disaster Protection Act of 1973 (P.L. 93 234) liistoric Preservation Act of 1966, as amended (tg l which requires recipients in a.special flood hazard U.S.C. 470), EO 11593 (identification and 1 area to participate in the program andto purchase protection of historic properties), and the flood insurance if the total cost of insurable Archaeological and liistoric Preservation Act of construction and acquisition is $10,000 or.more. 1974 (16 U.S.C. 469a-1 et seq.).

11. Will comply with environmental standards which 14. Will comply with P.L.93-348 regarding the may be prescribed pursuant to the following: (a) protection of human subjects involved in research institution of environmerital quality control development, and related activities supported bp' measures under the National Environmental this award of assistance.

Policy Act of 1969 (P.L.91-190) and Executive , 15. Will comply with the Laboratory Animal Welfare Order (EO) 11514; (b) notificat,on i of v,olating i Act of 1966 (P.L.-89-544, as amended, 7 U.S'C' f:cilities pursyant to EO 11738;(c) protection of 2131 et seq.) pertaining to the care, handling, and wetlands pursuant to EO 11990; (d) evaluation of treatment of warm blooded animals held for flood hazards in floodplains in accordance with EO research, teaching, or other activities supported by

• 11988;(e) assurance of project consistency with this award of assistance.

the approved State. management progrr.m developed under the Coastal Zone Management 16. Will co'mply with the Lead. Based Paint Poisoning Act of 1972 (16 U.S.C. 55 1451 at seq.); (f) Prevention Act (42 U.S.C. Il 4801 et seq.) which conformity of Federat actions to . State (Clear Air) prohibits the use of lead based paint in Implementation Plans under'Section:176(c) of the construction or rehabilitation of residence

. Clear Air Act of 1955, as' amended (42 U.S.C. I structures.

7401 et seq.);(g) protection of underground sources 17. Will cause to be performed the required I'mancial cfdrinking water under the Safe Drinkmg Water and compliance audits in accordance with the Act of 1974, as amended, (P.L. 93 523); and (h) S ngle Audit Actof1984 protection of endangered species under the Endangered Species Act of 1973, as amended,(P.L. 18. Will comply with all ap;'i:ab:e requirements of all 93-205). other Federal laws, executive orders. regulations and policies governir.c i: n program

12. Will comply with the Wild and Scenic Rivers Act cf 1968 (16 U.S.C. $$ 1271 et seq.) related to protecting components or potential components of the national wild and scenic rivers system.

l StGNATURE OF AUTHORIZED CERTIFYi G OFFt IAL TITLE I

Davi.d P. Westb ook Manager, Federal Contracts APPLICANT ORG ANtZATION DATE SUBMITTED NATIONAL ACADEMY OF SCIENCES

.:.. , , ,

• m.

. _ . = _ _ _ .- - ---- - - -- - - - - - - - -- -q KEY CONTACTS  !

'Authorizcd R2prenantativo sent indicated. to this individual for review and acceptance, unless otherwiseO Name:_ Charles E. Arbanas

Title:

_ Contract Manneer Complete Address:

_ Office of Contracts and Grants. National Academy of Sciences.

2101 Constitution Avenue. N.W. . Washin,tton, DC 20418 Phone Number: 202-334 2888 Payee: ' Individual authorized to accep't payments.

Name:

Title:

Cash Manaaement Section complete Address:_ Accounting Office, National Academy of Sciences, 2101 Constitution Avenue, N.W., Washington, DC 20418 Phone Number: 20Z-334- M Administrative contact:

to contact.concerning administrative mattersIndividual from Sponsored Programs Offic (i.e., indirect cost ,

rate computation, rebudgeting requests etc.) '

Name: Charles E. Arbanas

Title:

- Contract Manager

-Complete Address:_ as above Phone Number: an above Project Manager:  !

Individual responsible for the  !

completion of the proposed work. '

technical Name: Dr. R. F. (Rick) Jostes

Title:

Senior Prograra Officer Complete Address:_ Board on Radiation Effects Research National Research Council, 2101 Constitution Avenue, N.W. , k'ashington, DC 20418 Phone Number: 202-334-2232 l

1 NATIONAL ACADEMY OF SCIENCES - NATIONAL RESEARCH COUNCIL COMMISSION ON LIFE SCIENCES BOARD ON RADIATION EFFECTS RESEARCH l i

HEALTH RISKS FROM EXPOSURE TO LOW LEVELS OF IONIZING RADIATION (BEIR VII - Phase-2)

SUMMARY

The Office of Radiation and Indoor Air of the U.S. Environmental Protection Agency i (EPA), in cooperation with other agencies such as the U.S. Nuclear Regulatory l Commission and the U.S. Department of Energy, has consulted with the National j Research Council about the establishment of an committee to consider the large amount i of published data derived from molecular, cellular, animal, and human epidemiologic studies, and soon-to-be-completed studies, concerning the risks to humans of exposure to l Imy levels of ionizing radiation. All data and information available since the 1990 l lhological liffects of lonizing Radiation (BEIR V) report (Health Effects ofExposure to Lou Leveh v/ /onang Radiation) will be used to do a comprehensive reassessment of health risks resulting from exposures to ionizing radiation.

The proposed study. under the National Academy of Sciences' Board on Radiation litfects Research in the Commission on Life Sciences, would begin in the summer of 1W8. A small multidisciplinary committee of 8 members formed in 1996 conducted a phaw l woping study and determined that it is appropriate and feasible to conduct a reassessment of the health risks based on a review of the studies which have been published since BEIR V. The committee's recommendations were summarized in a letter report sent to EPA in January,1998. Those recommendations are justified in greater detail in a report titled Health Effects ofExposure to Low Levels ofIonizing Radiation:

Timefor Reassessment? The phase-1 study defined the most productive scope for an enlarged phase-2 committee and identified realistic goals and objectives for a phase-2 study which would result in a published report, BEIR VII. The proposed phase-2 study is estimated to cost approximately $1.19 million over a 36-month performance period.

ORIGIN AND BACKGROUND:

Since publication of the National Research Council's 1990 BEIR V report, new information on the Japanese atomic-bomb survivors and other cohorts exposed to ionizing radiation has become available. Studies at the molecular and cellular levels have pointed the way toward a better understanding of radiation carcinogenesis and might lead to aa improved basis for estimating risks associated wit' low doses and dose rates. In addition, there is new information on noncancer effects of radiation and a growing body of information about the processes by which exposures to other agents cause damage at the molecular and cellular levels that may have more general application. New statistical methods provide improved tools for characterizing risk.

Proposal No. 98-CLS-27 l-01 Page1

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The National Research Council established a committee to gather information from molecular, cellular, and animal studies of radiation, other environmental exposures, and l epidemiologic studies to evaluate whether such data might enable a BEIR VII committee l to reassess the health risks related to exposure to ' a-level ionizing radiation. In the i

preliminary scoping (phase-1) study, conunittee members conducted a review and l evaluated the scientific literature pertinent to the biologic and health effects of low-level ionizing radiation. It also made a concerted effort to learn about the status of relevant research in progress. Based on this review, the committee determined that sufficient infonnation has become available since the 1990 BEIR V report to warrant a compr;hensive reassessment of health risks in a phase-2-study by an enlarged committee (BEIR VII). The committee also considered such issues as estimation of dose and dose-rate reduction factors, evidence of thresholds or the lack thereof in dose-response relationships, the effect of the presence of possible groups in the population that are genetically predisposed to radiation sensitivity, and the influence of adaptive response and radiation hormesis on assessing the relative risk associated with low-dose exposure.s.

In addition, the committee commented on the potential for modifying models for projecting radiation-induced cancer risks in the U.S. population and recommended what could be done to measure and minimize the uncertainties in radiation-risk estimates. The committee identified sources of epidemiologic data including the Japanese atomic-bomb survivors, populations exposed in the former Soviet Union, nuclear workers in the United States and other countries, residents of high-background areas, and medically irradiated cohorts. A representative of the committee and NRC staff attended appropriate conferences focusing on the subject of the health effects of low-level ionizing radiation including the 1996 Interdisciplinary Meeting on Radiation Quality, Molecular Mechanisms, Cellular Effects and Health Consequences of Low Level Ionizing Radiation in Oxford, England, and the 1996 Intemational Conference en Radiation and Health in Beer Sheva, Israel. Finally, in assessing what other issues can be profitably addressed, the commit + : considered reviews conducted by other organizations since the release of BEIR V, suh as the United Nations Scientific Committee on the Effects of Atomic Radiation, the National Council on Radiation Protection and Measurements, and the National Radiological Protection Board.

The committee recommended issues that could profitably be addressed in a BEIR VII study, provided justification and a basis for those recommendations, listed primary sources of data that might be used, assessed whether a detailed analysis of particular issues could have an important effect on the measurement or validity of radiation risk estimates, and indicated what scientific disciplines should be represented in order for a committee to address the key issues adequately in a phase-2 study.

The phase-1 committee 'sjudgment was based on thefollowing considerations:

Substantial new epidemiologic evidence has accumulated since the 1990 BEIR V report was published. The committee's nbase-1 report cited 39 new epidemiologic Proposal No. 98-CLS-271-01 Page 2

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studies that fall into this category. Additional studies that have a direct bearing on the subject should become available in the next 3 years, the estimmed period required to complete the phase-2 study.

• Some of the new epidemiologic data are on subjects on which information had been l sparse, such as cancer monality in those exposed to whole-body irradiation in j childhood.

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• Studies of carcinogenesis completed since publication of the last BEIR report have focused on mechanisms and the cellular and molecular events that are involved in the neoplastic process.The understanding of' molecular events involved in carcinogenesis j has increased. significantly. Mechanisms that might be involved in radiation L carcinogenesis have been identified. Further knowledge of these mechanisms that -

l should become available in the next 3 years might affect estimation of the radiation-i response curve at low doses.

l l e Over the next few years, investigators will be applying two closely linked approaches l using animal models of carcinogenesis. Those' approaches will likely contnbute to a l better understanding of mechanisms of radiation-induced cancer. In the first of these ,

two approaches, genetically engineered mice having alterations in specific genes will l be used to determine the influence of these genes on the susceptibility of the mice to radiation-induced cancer. In the second approach, studies will be conducted of the inherent differences in susceptibility to radiation-induced cancer among different mouse strains, the objective being to identify the genes involved in controlling susceptibility. Researchers responsible for this new generation of animal studies are taking advantage of the current rapid developments in molecular genetics. Progress on both approaches should be substantial over the next few years. Significant results of relevance to risk estimation are expected to be available for the proposed BEIR Vil phase-2 study.

• Evidence regarding specific biologic events that can affect the shape of the dose-response curve at low doses is also accumulating. Information on such phenomena as DNA repair, signal transduction, chromosomal instability, and hormesis, although preliminary, might eventually affect risk analyses of low-dose and low-dose-rate exposures.

State and federal governments have relied, in part, on the BEIR studies of the National

. Research Council to provide a scientific benchmark in promulgating regulatory standards and advisory recommendations. New information has prompted renewed questioning of the postulated linear nonthreshold dose-response relationship at low levels of exposure such as natural background or very small incremental doses above natural background.

l Such speculation has raised questions as to how, in view of current biologic and

epidemiologic information, regulatory bodies should characterize risks associated with the doses and dose rates experienced by radiation workers and members of the general Proposal No. 98-CLS-27101 Page 3

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public and at levels where 'most regulatory standards are set. The full-scale BEIR VII ,

review and analysis ~will be aimed at updating the assessment of risks related to low-dose, low-LET radiation and exploring all that is known regarding the biologic processes l- determining those risks. The dose response for other types of radiation (i.e. alpha

. particles and neutrons) should be considered to the extent necessary to optimize risk -

estimates for exposure to low-LET radiation.

PROPOSED ACTIVITY: .

The National Research Council will establish a committee of approximately 15 persons to perform phase-2 of the' BEIR VII study. In order to perform its work, the committee ,

would be expected to review the following:

. Low-dose (e.g., < 0.1 Sv) human cancer risk estimation for single or multiple acute r

' doses or for continuous lifetime exposure.

Estimation ofdose and dose-rate reduction factors (DDREF)in humans Evidence for or against thresholds Evidence for or against adaptive responses or radiation hormesis which modify nsk estimates in humans for exposures to low doses (indicating over what range of doses and dose rates the modifiers would be expected to operate

- and the magnitude of the effect on risk estimates)

• Numerical risk estimation Estimation of radiation-induced cancer risks from all sources including ,

background and variation 'in background in the U.S. population by modification of models Estimation of uncertainties in radiation risk estimates including dosimetric uncertainties in the epidemiologic studies upon which the risk models are based e Subpopulation sensitivity estimation Identification of subpopulations possibly more sensitive to the effects ofradiation To the extent possible, estimation of the number of people in sensitive subpopu-lations and the expected magnitude and uncertainty of the effect on risk assessment In order to do their task, the committee will consider all published results including (but not limited to) the following: .

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e Japanese atomic-bomb survivor data ,

Cancer incidence and mortality data available since the BEIR V analysis Dependence of risk of cancer on cancer site, age, and time since exposure New dosimetric information, particularly pertaining to neutmn doses at Hiroshima Evidence for noncancer effects, including genetic, reproductive and developmental, cardiovascular .

Other epidemiologic data which could be reviewed for all health effects including effects other than cancer (as described for the Japanese data above)

Medically-irradiated cohorts where results can be uaed to test or improve risk

- models i Populations chronically exposed to low, moderate, or high doses oflow- and/or high-LET radiation, including groups exposed in the former Soviet Union (e.g., Chemobyl, Mayak workers, and Techa River cohort), nuclear l workers and airline flight crews in the U. S. and other countries, and other i suitable population groups, such as residents of high background areas '

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. Laboratory studies pertaining to mechanisms of radiation-induced carcinogenesis ,

Occunence of various types of DNA damage secondary to cell metabolism and DNA replication, and damage induced by ionizing radiation j l Efficiency of DNA repair processes to include repair of spontaneous and radiation-induced DNA damage

!- Importance of specific genetic changes caused by radiation or other agents in carcinogenesis l Influence of the cell cycle on radiation-induced cellular changes and repair

-The Research Council Committee on Dosimetry for the Radiation Effects Research Foundation (RERF) is currently evaluating the status of the dosimetry for the Japanese atomic-bomb survivors (DS86) with particular attention being given to. recent p measurements which have suggested that there appears to be a discrepancy between these measurements and the DS86 estimate of neutron flux at certain distances. If there are modifications made to the RERF dosimetry during the course of the BEIR VII-phase-2 study, it will be important for the BEIR committee to consider the impact of any proposed revisions on risk assessment. If major changes are expected to be made in

DS86, it may be necessary to interrupt the BEIR study and delay its fir.al report until the l- changes in DS86 can be incorporated into the BEIR VII risk assessment.

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\ The group responsiblefor the proposedphase-2 study will l-

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. Conduct a comprehensive review of all relevant epidemiologic data related to the risk

? from exposure to low-doses, low-LET radiation.

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' Proposal No. 98-CLS.271-01 Page 5

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• Define and establish principles on which quantitative analyses can be based, including requirements for epidemiologic data and cohort characteristics. In this respect, the group should consider biologic factors (such as the dose and dose-rate effectiveness factor, relative biologic effectiveness, genomic instability, and adaptive responses) and appropriate models (favoring simple as opposed to complex models) to develop  !

etiologic models and estimate population detriment.

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• Assess the current status and relevance to risk models of biologic data and models of carcinogenesis. This should inclade a critical assessment of all data that might affect the shape of the response curve at low doses, in particular, evidence of thresholds or the lack thereofin dose-response relationships and the influence of adaptive responses and radiation hormesis.

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• Consider potential target cells and pmblems that might exist in determining dose to the target cell.

. Consider any recent evidence regarding genetic effects not related to cancer. Any such data, even if obtained from high radiation exposures or at high dose rates, should

. be considered.

With respect to modeling, the group responsiblefor the proposedphase-2 study will e Develop appropriate risk models for all cancer sites and other outcomes for which there is adequate data to support a quantitative estimate of risk, including bemgn disease and genetic effects. Specifically, the responsible group should consider the fitting of purely empirical models to original data from studies or combined studies, ,

the fitting of purely empirical models with meta-analytic techniques, and the fitting of semiempirical biology-based models to epidemiologic data including uncertainties.

• Provide examples of specific risk calculations based on the models and explain the .

appropriate use of the risk models.

• Describe and define the limitations and uncertainties of the risk models and their results. The group conducting the proposed phase-2 study should be directed to i

, develop best-risk estimates as opposed to developing conservative models for purposes of radiation protection.

• Discuss the role and effect of modifying factors, including host (such as individual susceptibility and variability, age, and sex), environment (such as altitude and air pollution), and lifestyle (such as smoking history and alcohol consumption).

• Identify critical gaps in knowledge that should be filled by future research.

Proposal No. 98-CLS.27101 Page 6

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. To accomplish the above charge, the membership of the group responsible for the proposed BEIR VII phase-2 study will require expertise in epidemiology, biostatistics, L radiation physics and dosimetry (an expert who can evaluate the quality of dose estimates for the various epidemiology studies), risk communication, molecular biology, risk assessment, cancer modeling, animal and cellular radiation biology, somatic ccii genetics, cell-cycle regulation and apoptosis, and ionizing radiation-induced DNA damage and its repair. Committee membership will be subject to National Research Council approval and conflict ofinterest and bias procedures. .

It is anticipated that the committee will hold at least 3 meetings a year during the 36 -

month study period. An attempt will be made to plan some committee meetings in association with meetings of radiation research professional societies such as the Health Physics Society and the Radiation Research Society. At least 3 workshops or symposia will be organized in order to receive input from a variety of public and scientific interest groups.

PRODUCT AND DISSEMINATION PLAN:

The committee will produce a consensus report that contains conclusions and recommendations regarding the health risks related to exposure to ionizing radiation. The BEIR VII report will be reviewed and wwei> dissemmated m accord with National Research Council procedures.

1 Reports resulting from this effort shall be prepared in sufficient quantity to ensure their distribution to the cosponsor, to committee members, and to other relevant parties, in accordance with Academy policy. Reports will be posted on the Intemet and made available to the public without restrictions.

FEDERAL A_DVISORY COMMITTEE ACT: i The Academy has developed interim policies and procedures to implement the Federal  ;

Advisory Committee Act, 5 U.S.C. Q l et seq. (FACA), as amended by the Federal Advisory Committee Act Amendments of 1997, H.R. 2977, signed into law on December 17,1997 (FACA Amendments). The FACA Amendments exempted the Academy from most of the requirements of FACA, but added a new Section 15 that includes certain requirements regarding public access and conflicts of interest that are applicable to l agreements under which the Academy, using a committee, provides advice or recommendations to a Federal agency. In accordance with Section 15 of FACA, the Academy shall deliver along with its final report to the cosponsors a certification by the Responsible Staff Officer that the policies and procedures of the National Academy of Sciences that implement Section 15 of FACA have been complied with in connection with the performance of the contract / grant / cooperative agreement.

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Proposal No. 98-CLS 271-01 Page 7 i

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= PUBLIC INFORMATION ABOUT Tile PROJECT: ,

The National Research Council will post on its web site (http://www.nas.edu) a brief .

-l description of the project, as well as committee appointments with short biographies of j

the members, meeting notices, and other pertinent information, to afford the public q

greater knowledge of our activities, and an opportunity to make comments.

l The web site will also include an ongoing record of compliance _to the requirements of. 'l Section' 15 of the Federal Advisory Committee Act. Amendments of 1997, and a certification of compliance will be provided when the study is completed.  ;

ESTIMATE QE COSTS:

The total estimated ~ cost of the 36-month study is approximately $1,195,000. Funds are requested from the Environmental Protection Agency, the Nuclear Regulatory. [

Commission, and other interested Federal agencies for the period from September 1,1998 i through August 31,2001.  !

Funds.are requested to provide the National Research Council staff labor costs to

' assemble the necessary committee; to arrange for and coordinate the meetings and functions f the committee; to prepare, assemble, edit, - review, duplicate and dissemina committee reports; to provide current and archived scientific information p through searches of the research literature, to enable staff attendance at appropriate scientific meetings, and to provide for specialists to appear at committee meetings as requested by the committee members and as needed to produce quality. reviews and reports.

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NATIONAL ACADEMY OF SCIENCcS-NATIONAL RESEARCH COUNCIL

-- 1 COMMISSION ON LIFE SCIENCES I

, BOARD ON RADIATION EF5ECTS RESEARCH Proposal No. 98 CLS 271-01 l

HEALTH RISKS FROM EXPOSURE TO LOW LEVELS

- OF IONIIING RADIATION (BEIR Vil Phase 2) l Environmental Protection Agency Summary Estimate of Costs 9/1/98 to 8/31/01 l AMOUNT l Direct Labor $391,133 Overhead - $237,535 Overhead Cost of Money $4,532 Travel $286,545 Reports $14M20 TQchnology/ Communication $34,104 Technology Cost of Money $580

' Meeting Expense $25,092 I

Other Direct Costs $12,837 Subtotal: iLOO6.778 Generaland Administrative Costs $187,060 G&A Cost of Money $1,162 Total: $1,195,000 Amount Requested From EPA bi,4Yd,000j Footnote: These mojor cost categories reflect the billing structure used by the National Academy of sciences.

Cost and rote dato are ottoched as background informotion and for use in the negotiotion process.

Please be advised, however, that oil costs are systernotically collected in our accounting sy',*em and are ovolloble for audit through crrangements with the Defense Contract Audit Agency and our ce,gnitont Administrative l

l Contracting Officer et :he ofrce of Novol Research.

Proposal No. 98-CLS 271-01 Page 9

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NATIONAL ACADEMY OF SCIENCES-NATIONAL RESEARCH COUNCit COMMISSION ON LIFE SCIENCES ,

BOARD ON RADIATION EFFECTS RESEARCH Proposal No. 98-CLS 271-01 HEALTH RISKS FROM EXPOSURE TO LOW LEVELS OF lON! ZING RADIATION (BEIR Vil Phase 2)

Environmental Protection Agency Summary Estimate of Costs 09/01/98 6o 08/31/99 Y

AMOUNT Direct Lobor $122.081

$74,140 Overhead Overhead Cost of Money $1,415 Travel $95.515 Reports $406 Tuchnology/ Communication $11,190 Technology Cost of Money $190 Meeting Expense $8,364 Other Direct Costs $3.809 Subtotc;: 5317.110 General and Administrative Costs $58,919 G&A Cost of Money $366 Total: $376,395 Amount Requested From EPA 53/o,3Y5 l l

Footnote: These molor cost categones reflect the billing structure used by the National ACodemy of sciences.

Cost and role doto are ottoched os bockground information ond for use in tne negotiotion process, Please be odvised. however, thof oil costs are systematico#y collected in our occounting system and ore ovoilable for oudit throught arrongements with the Defense Controct Audit ADency and our cognizont Adrrwnistrotwo Contractog Officer of the office of Novol Research.

Proposal No. 98-CLS-271-01 Page 10

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ESilMA? ION DETAILS PROVIDED FOR NEGOTIATION PURPOSES ONLY

'T NATIONAL ACADEMY OF SCIENCES-NATIONAL RESEARCH COUNCIL COMMISSION ON LIFE SCIENCES i

BOARD ON RADIATION EFFECTS RESEARCH Proposal No. 98-CLS-271-01 HEALTH R!SKS FROM EXPOSURE TO LOW LEVELS OF lONIZING RADIATION (BEIR Vis - Phase 2).

Estim' ote of Cos's 09/01/98 to 08/31/99 12 months DIRECT LABOR, ON-SITE Percent Annual Toto! Project Hrs ' of Time Solary Solory Totals Direc!cr U.5 5% $100,000 $5,000 Stoff Off ca- -1365 70% 79,500 55,650 Admin Anoc  ; 9.5 1% 55.700 557 Editor '19.5 1% 83,700 837 Total Exemp' ' $62.044

. Fall Non-Exemot -

. Project A: *

.975 50% $28,000 $14,000 Project Asst 487.5 25% 27,000 6,750 Admin Assist 390 20%' 46,400 9,280

. Total Non-Exempt ' $30,030

- Total Fall Solaries $92,074 Total Solary Adjustments [1] $3,376 L Total Direct Labor, On Site . (2) $95A50

' Fringe Benefits @ 27.90% of Solaries $26,631 T87AL DIRECT LABOR, ON SITE, PLUS FRINGE -

$122,081 SUBTOTAL (On-site Overhead Base) $122,081 OVERHEAD, On-site 60.73% of Base $74,140

COST OF MONEY (Lobor) 1,1587% of Bose $1,415

TOTAL OVERHEAD, On Site (3) ' $75,555 Proposat No. 98-CLS-27101 PageIi

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OTHER DIRECT COSTS iTravel Expenses (Domestic)

Days / #Per Mfg l X Mfg. Cost - $\ Mfg Subtoto!

' #Pers. #Mfgs ' Mtg .

3 13 $1,085 - $14,105 Experts - 13 1 13 51,085- 14,105 Experts 13 1 3 13 $1,085 14,105 Experts . 13 - 1 3 13 51,250 16,250 Experts .13 1 '4

$58,565 4 ,12' 51,250 $15,000  ;

inv. .12 - 1 l

- $15,000 4 3 $1,250 $3.750 Stoff 3= 1 4 3 $1,250 3,750 Staff 3 1 2 $1,415 2,830

- Stoff 2 1 5 4 2 $1,250 2,500 Stoff - 1 2

$12,830

$86,395 ,

Total Domestic Travel Travel Expenses (International)

Experts .

Fore From To #Pers # Mfg. R/T Subtotals 3 1. $1,500 $4,500 Europe. DC-

$4,500

' Stoff Fore

~ Frorn To #Pers # Mfg. R/T Europe 1 $1,200 $1,200

-DC~ 1

$1,200 ,

Experts .

Per Diem . # Days #Pers #Mtg. Rote 3 $168 $2,520

-DC' 5 1 ,

$2,520 Staff Per Diem # Days #Pers #Mtg. Rote

. Cambridge 5 1 1 $180 $900

$900

$9,120 TotalinternationalTravel

$95,515

- Total Travel Other Costs

Reports and Stationery (4)

Stationery and Envelopes $'406 Votal Reports and Stationery $406 Proposai No 98-C1.5-27101 Page 12

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.. i Phot:ceplas (5) $95 /mo $1,135 l

P:stig2 cnd D: livery I

, Project $85 /mo $1,020

' l Technology /Communicallons

- Long Distance Telephone $75.00 /mo $900 I

. Tel. Equip. Charge (6) . $161.55 /mo $1,939 Fox, Modem Analog Lines $5.91 /mo $71 l Technology Services (7) $689.96 /mo $8,280 Cost of Money $15.81 /mo $190

' Office supplies $100 /mo $1,200 Meeting Expenses ,

$8,364 ' l Rote #Pers. #Doys I Woods Hole Focility Use $24 17 2 $316 Woods Hole Meols $20 17 2 $680 1

- Beckman Ctr. Meals $23.75 17 2 $808 .

. Books and Periodicals (e.g., newsletters, interlibrary loon) ' $454 i

Total Other $23,959 TOTAL OTHER DIRECT COSTS $119,474 l l

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~5UBTOTAL - $317,110 I i

General & Administrative Costs - ' l' 8.58% of Net Direct Lobor. Overhead, and Direct Costs. $58.919 i

, Cost of Money 0.1154% of Net Direct Locor. Overheod. and Direct Costs, $366 {

TOTAL GENERAL AND ADMINISTRATIVE COSTS (8) $59,285 )

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TOTAL ESTIMATED COST $376,395 l

Amount Requested From EPA . $376,395

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l it is requested that the award will provide for payment via Pool Agreement, Letter of Credit, or electronic transfer, i

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FOOiNOTES

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' I, . An onnvol adjustment is opplied it, 'he sofory base to provide for merit increases that will be awarded during the performance period of any award resuffing from this  ;

I proposol/ The effective date for estimating such adjustments is May 1 for those programs conducted under the " Spring Schedule" units and October 1 for those programs conducted under the '7011 Schedule" units, l i

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3. ~

Direct Labor includes on occruol for personal leove, holidoys. and other leave. Such as -

' jury duty and military service, of a rate of 18.2%. ,

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3. The total on-site overhooo role includes o facilities copitol cost of money factor, s

The fotol off-site overhood rote includes o facilities capitol cost of money factor, r'

The NRC onnuolly drows upon more than 9.000 volunteer scientists. ,

engineers. ond other professionals. largely from universities and industry, Plocing the value of these donated services in the Overhead base would result i in significantly reduced Overhead and G&A rotes.

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Reports - e..e pm Reports Internet ,

4.,

Estimated report production (coo er 0 0 i;

Estimated report per copy cost 500.00 $0.00 - $0.00 ,

l.51330% 1.51330% i NAP cost of money factor I.51330% (% of cost)'

Estimoted total report charge per c?r. 50.00 $0.00

[

(- $0.00

' Estimated total report chorge ' $406.05 $0.00 t

The reports cost of money is calculo'ed c. *r.3 the fotol cost of producing reports by the cost of money factor. c

3. Copying .

- Estimated pages 25.000 Rote per Page ~ $00445 /pg Copying cost of money factor $0.0009 /pg j

Estimated copying charges $1.135 ,

Copying is estimated on a monthly basis. The total estimated copying charge is e IT . derived by determining the total estimated number of pages that might be reproduced based on similar projects undertaken by the NRC

(. - and multiplying by the negotioted per copy rate. The negotiated per copy

' rote inciv' des o negotiated per copy cost of money foctor, T6.. Communications Prorated Telephones - 1.72 (Total Full-time Eauivoient employees reflected in estimated soloried staff and on-site borrowed personnel percent of time in Direct Labor section of estimate.)

L j ProposalNo 98 CLS-27101 Page 14 I!

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e Iotal basic 6QuipmJnt Chorge. Digitot $43.35 l 1

, Basic equipment Chg., Digito! $40.98 /bi-wk  ;

1 Tel, cost of money foctor, per phone $2.3704 /bi-wk (not opplied to Long Distance)

Telephone equipment charge equals Prorated Telephones times the total bosic equipment charge, biweekly. times the number of pay per :ds covered by the estimate.

Estimated use of Fox / Modem .20 i

Total basic equipment charge. Anolog _ $13.65 Basic equipment chg. Anolog $12.90 /bi-wk Analog cost of money factor, per in $0.7481 /bi-wk Fox / Modem lines are shared on on ecuol bosis with other projects.

7. Technology Prorated PCs 1.72 (Total Full-time Eovivolent employees reflected in estimated saloned staff and orn 'a norrowed personnel percent of time in Direct Labor section of estimate.)

W. !ac.ntioiogy Services chorge $189.38

• e:- :'s;/ Services chg. per PC $185.14 /bi-wk

'e:m cost of money factor per PC $4.24 /bi-wk iechnology services charge equois Prorated PCs times the total basic equipment charge, biweekly times the number of pay periods covered by he estimate.

8. The use of oil rotes in this proposol hos been opproved by the Administrative Contracting Officer, Office of Novo! Research to assist sponsors in occurate forword pricing. The NRC

- indirect rotes are negoticled with the Office of Novol Research on a yearly basis.

The proposed rates are fixed rote corry forward which means that the rates may change for subsequent NRC fiscal years (July 1 through June 30). The NRC must propos3 using the roles in effect of the time of the proposol However, for contract billing purposes.

the rates proposed may change for subsequent NRC fiscal years and it is understood tnot any contractually stipulated indirect rate would be modified in accordance with any revised negotioted indirect rates. Indirect rotes include the Corrtrsponding negotiated rote ogreement cost of money factors.

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Rote Toble: Rot 3 Before Cost of Cost of Money NAS FY 98 RATES Money Additive TotalRote 33.99 % 0.1394 % 34.1294%

Offsite Overheod 60.73 % 1.1587% 61.8887%

Regular Overhead 1.95% 0.0087% 1.4587%

Flow-through Admin 18.58% 0.1154% 18.6954%

G&A Copy Center 50.0445 $0.0009 $0.0454

$40.98 $2.3704 $43.35 Telephone: Digital _

$12.90 $0.7481 $13.65 Telephone: Analog

$185.14 $4.2428 $189.38

'echnology

.18.2% - 18.2%

Leove -

27.9% - 27.9%

Fringe

. l.5133% 1.5133%

NAP Poy Periods 26 2.16667 per month Woods Hole Focility Use $24 per day Woods Hole Meals

$20 per person. per doy Beckmon Center Meois $23.75 per person. per doy Page 16 Proposal Ne '-3.CLS-27101

r H NATIONAL ACADEMY OF SCIENCES-NATIONAL RESEARCH COUNCll I

<. COMMISSION ON LIFE SCIENCES BOARD ON RADIATION EFFECTS RESEARCH Proposal No. 98 CLS 27101 HEALTH RISKS FROM EXPOSURE TO LOW LEVELS .-

OF lONIZING RADIATION (BEIR Vil - Phase 2) ,

Environmental Protection Agency Summary Estimate of Costs j 09/01/99 to 08/31/00 i

AMOUNT Direct Labor 5126 701 Overhead 577 000 Overheoc Cost ofIAoney $' 460 Trovel 505 5?S Rsports . 5406 1 Tcchnology/ Communication - 511. t 90 TIchnology Cost of Money -

5190 -

Meeting Expense. 58 364

' Other Direct Costs .

53.907 Subtotal:' $324,832

' General and Administrative Costs $60,354 G&A Cost of Money , $375 Total: $385,561

. Amount Requested From EPA 5,25,5o1 l l

.. Footnote: These major cost categories reflect the billing structure used by the National ACodemy of sciences.

Cost and rote dato are ottoched os bockground information and for use in the negotiotion process. Please be odvised, however, thot oil costs are systernoticol!y collected in our accounting system and are ovoilable for oudt throught ortongements with the oefense Contract Audi Agency and our Cognizont Admry ' ofwe Contractop offica of the office of Novol Reseorch.

Proposal No 98-CLS-2?l 0) . Page 17

ESilMATION DETAILS PROVIDED FOR NEGOTIAflON PURPOSES ONLY NATIONAL ACADEMY OF SCIENCES-NATIONAL RESEARCH COUNCll COMMISSION ON LIFE SCIENCES BOARD ON RADIATION EFFECTS RESEARCH Proposal N198-CLS-27l-01 HEALTH RISKS FROM EXPOSURE TO LOW LEVELS OF lONIZING RADIATION (BEIR Vil - Phase 2)

Estimate or Costs ,

09/01/99 to 08/31/00 12 months

DIRECT LABOR, ON SITE Percent Annual Total Project ,

of Time Solory Solory Totals Fa1 E nemot 5% $100,000 $5,000 Director i " " ^"ar 70% 79,500 55,650 l

A 0-" Assoc - 1% 55,700 557 Ecact 1% 83,700 837

$62,044

• *:r Enemot l~ so" Non Exempt l DrOject Asst 50% $28,000 $14,000 Droject Asst 25% 27,000 6,750 -

Admin Assist 20% 46,400 9,280 Total Non-Exempt $30,030 l-t.

Totol FallSolaries $92,074 I-Total Solory Adjustments [1] $7,059 l --

l Total Direct Labor, On Site $99,133 (2)

Fringe Benefits @ 27.90% of Solaries $27,658 l'

l l

' TOTAL DIRECT LABOR, ON SITE, PLUS FRINGE $126,791 l

$126,791 SUBTOTAL (On-site Overhead Bose)

OVERHEAD, On-site 60.73% of Bose $77,000 1.1587% of Base $1.469

( COST OF MONEY (Lobor)

. TOTAL OVERHEAn On Site (3) $78,469 l

l' 1-Proposal No 98-CLS 271-01 Page18 i

i.

_. .- -. . . . ~ - - - . . - . . . _ . - . - . . . - _ . . - - - . . . -.

l OTHER DIRECT COSTS Travel Expenses (Domestic) 4 Doys/ #Per Mig

1. Pers. # Migs Mtg X Mfg. Cost $\ Mig . Subtotal l

E>.perts <13 1 3 13 $1,085 $14,105 '

j Experts 13 1 3 13 $1,085 14,105 ,

l' ~ Experts 13 1 3 13 $1,085 14,105 +

Experts 13 1 4 13 $1,250 16,250

$58,565 inv. 12 - 1 ~4' 12 $1,250 $15,000

$15,000 Stoff 3 1 '4 3 $1,250 $3,750 Stoff 3 1 4 3 $1,250 3,750 Stoff 2 1 5- 2 $1,415 2,830 Stoff 1- 2 4 2 $1,250 2,500 i

$12,830

.]

Total Domestic Trovel $86,395 .

' Travel Expenses (International)

Experts Fore From To #Pers #Mtg. R/T Subtotols

. Europe 'DC. 3- 1- $1,500 $4,500

$4,500 Stoff Fore Fro m To #Pers #Mtg. R/T DC Europe 1 1 $1,200 $1,200

$1,200 Experts Par Diem #Doys #Pers #Mtg. Role

]

DC 5 3 1 $168 $2,520 ,

$2,520 Stoff Pcr Diem #Doys ' #Pers # Mig. - Rote

' Cambridge S 1 -1 $180 $900

$900 1Totalinternational Travel $9,120 Total Travel $95,515  :

Other Costs R; ports and Stationery (4)

Stationery and Envelopes $406 Total Reports ono stationery $406 Phtfocopies (5) $95 /mo $1,137

' Proposa! No 98-CLS 27101 Page 19

F Pist::ge end Delivery

$85 /mo $1.020 ,

ProJ:ct T:chnology/ Communications

$75.00 /mo $900 Long Distance Telephone

$1,939 Tel. Equip. Chorge (6) $161.55' /mo

$71 Fox, Modem Analog Lines $5.91 /mo

%8.280 Technology Services (7) $689.96 /mo Cost of Money $15.81 /mo 4'70

$1,200 Office supplies $100 /mo

$8,364

- Meeting Expenses Rote #Pers. # Days ,

Woods Hole Facility Us $24 17 2 $816 Woods Hole Meois $20 17 2 $680 2 l

- Beckman Ctr. Meals $23.75 17 $808 Sooks and Periodicals (e.g., newsletters, interlibrary loon) $550

$24,057 Total Other

$119,572 1 TOTAL OTHER DIRECT COSTS S324,832 SU8 TOTAL 18.58% of Net Direct Labor, Overneod. ond Direct Costs 500 35 t General & Administrative Costs 0.1154% of Net Direct Lobor. Overhead, and Direct Costs $375 Cost of Money 540.729 TOTAL GENERAL AND ADMINISTRATIVE COSTS (8) 5385.541 TOTAL ESTIMATED COS' Amount Requested From E*A $385,541 It is requested that the award,will provide for payment vio Pool Agreement, Leffer of Credit, or electronic transfer.

i l-l I

I I~ Page 20 Proposal Nt 98-CLS-271-01 l

l FOOTNOTES

1. An onnvol odjus? ment is coolied to the sofory base to provide for merit increases thot will be awarded during the performance period of ony oward resulting from inis proposol. The effective dote for estimoting such od;ustments is May I for those programs 1

conducted under the "Spnng Schedule" units and October I for those programs conducted under the "Foll Schedule" units.

2. Direct Lobor inClvdes on oCCrvol for personal leove. hokdays. ond other leove. such as jury duty and mihtory service, of a rote of 18.2%.

3. The total on-site overhead rote includes o facilities capitot cost of money factor.

The total off-site overhead rate includes o focilities capitol cost of money factor.

The NRC onnvolly drows upon more than 9,000 volunteer scientists.

engineert and other professionals. largely from universities and industry.

Plocing the volve of these donated services in the Overhead base would result in significantly reduced Overheod and G&A rotes.

Statiorierv ond

4. Reports E..m Pecorts internet Estimoted report production (copies) 0 0 Estimated report per copy cost 14c0 ? $0.00 50.00 NAP cost of money factor i ', . . . n 1.51330% 1.51330% **

Estimated fotot report chorge per copy 50.00 50.00 Estimated total repori charge SA~e T> $0.00 50.00 I

The reports rNt of money is calculoted by multiplying l the tW cost of producing reports by the cost of money fo:':-

l 5 Copying 1

Estimated pages 25.050 Rote per Poge 50.0445 /pg Copying cost of money factor 50.0009 /pg l Estimated copying charges $1.137 .

I Copying is estimated on c enonthly basis. The total estimated copying charge is derived by determining theiotal estimated number of pages that might be reproduced based on similor projects undertaken by the NRC ond multiplying by the negotioted per copy rote. The negotiated per Copy rote includes o negotioted per copy cost of money foetor.

4

6. Com nunications Protoled Telephones 1.72 (Totot Full-time Eavivoient employees reflected in estimated solaried stoff ond on-site borrowed personnel percent of time in Direct Lobor section of estimate.)

Proposal No 98 CLS-271-Un - Page 21

Total basic equipment chorg3. Digital $43.35 Basic equipment Chg., Digital $40.98 /bi-wk .

Tel. cost of money factor, per phone $2.3704 /bi wk (not opolied to Long Distance)

Telephone equipment Chorge equals Prorated Telephones times the total basic equipment charge, biweekly, times the number of poy periods covered by the estimate.

Est;moted use of Fox / Modem .20 Total basic equipment chorge, Analog , $13.65 Bosic equipment chg., Analog $12.90 /bi-wk Anolog cost of money factor, per in $0.7481 /bi-wk Fox / Modem lines are shared on on equal basis with other projects.

7. Technology Proroted PCs 1.72

{ Total Full-time Eovivolent employees reflected in estimated solaried stoff and on-site b'orrowed personnel percent of time in Direct Lobor section of estimate.)

Total Technology Services chorge $189.38 Technology Services chg. per PC $185.14 /bi-wk Tech. Cost of money factor per PC $4.24 /bi-wk Technology services charge equals Prorated PCs times the foto! basic equipment Chorge, biweekly, times the number of pay periods covered by the estimate.

8. The use of all rotes in this proposal hos been opproved by the Administrative ControCting Officer. Office of Novol Reseorch, to assist sponsors in occurote forward pricing. The NRC indirect rates are negotiated with the Office of Novol Reseorch on o yearly bosis.

The proposed rotes are fixed rote carry forward which means that the rotes may change for subseovent NRC fiscal years (July 1 through June 30). The NRC must propose using the rcles in effect of the time of the proposol. However, for contract billing purposes, l

the rates proposed may change for subsequent NRC fiscal years and it is understood that any Contractually stipuloted indirect rote would be modified in oCCordonCe with ony revised negotiated indirect rotes. Indirect rates include the corresponding negotioted rote ogreement cost of money factors.

1 i

l l

l l

ProposalNo 98 CLS-278-01 Page 22

i.

Rot:, Itbie: 1 i

• Rats 1 l Before Cost of NAs FY 98 RATES Cost of Money

]

Money Additive Total Rote t Offsite Overhead 33.99 % 0.1394% 34.1294%

l Regulor Overhead 60.73% 1.1587% 61.8887%

Flow-through Admin 1.95% 0.0087% 1.9587%

G&A- 18.58 % 0.1154% 18.6954%

l Copy Center 30.0445

$0.0009 $0.0454 Telephone: Digital $40.98 32.3704 $43.35 l Telephone: Anclog $12.90 $0.7481 $13.65 Technology $185.14 $4.2428 $189.38 l Leove 18.2 % 4 18.2%

Fringe .

l 27.9% -

27.9%

i NAP . l.s132% 1.5133%

Pay Periods 26 2.16667 per month Woods Hole Facility Use $24 per doy Woods Hole Meals $20 per person. per day Beckmon Center Meals $23.75 per person. per doy I

)

l l

i l'

l Proposal No 98-CLS.271-01_ Page 23

NATIONAL ACADEMY OF SCIENCES-NATIONAL RESEARCH COUNCll COMMISSION ON LIFE SCIENCES BOARD ON RADIATION EFFECTS RESEARCH Proposal No. 98 CLS 271-01 HEALTH RISKS FROM EXPOSURE TO LOW LEVELS OF IONIZING RADIATION (BEIR Vll - Phase 2)

Environmental Protection Agency Summary Estimate of Costs 09/01/00 to 08/31/01 AMOUNT

$142,261 Direct Labor

$86,395 Ovetheod Overhead Cost of Money $1,648 Travel $95,515 Raports - $1 ?,i,08 Tschnology/ Communication $11,724 Technology Cost of Money $200 Mseting Expense $8.364 Other Direct Costs $5.121 Subtotal: $364.836 Ganeral and Administrative Costs $67,787 G&A Cost of Money $421 Total: $433,044 Amount Requested From EPA 5433,044 l l

Footnote: These rnoior cost categories reflect the tang structure used by the Nationol ACodemy of sCsences s Cost and rate coto are ottoched os bockground informotion and for use in the negotiation process. Please be odvised, however, thot ou costs are systemoticolly collected in our occounting system ond are avoilable for oudit throught arrangements with the Deferfse Contract Audit Agency ond our cognizont Admirustrotive Contractog officer of the office of Novol Research.

Proposal No. 98-CLS-271-01 Page 24

, l ESilMATION DETAILS PROVIDED FOR NEGOTIATION PURPOSES ONLY l i NATIONAL ACADEMY OF SCIENCES-NATIONAL RESEARCH COUNCIL COMMISSION ON LIFE SCIENCES BOARD ON RADIATION EFFECTS RESEARCH l

1 Proposo'l No. 98-CLS-271-01 HEALTH RISKS FROM EXPOSURE TO LOW LEVELS

- OF lONIZING RADIATION (BEIR Vil Phase 2) -

)

I

. Estimate of Costs 1

-09/01/00 to 08/31/01 12 months ,

1 DIRECT LABOR, ON SITE - Percent Annual Total . Project

. of Time Solary Solary Totals Fall Exempt Director 5% $100,000 $5,000 Stoff Office- 70% 79,500 55.650 Admin Asse- 1% 55,700 557 Editor 10% 83,700 8,370 Total Exempt $69,577 Fall Non-Exempt Project Asst . 50% $28,000 $14,000 Project Asst - 25% -27,000 6.750 Admin Assist 20 % 46,400 9,280

$30,030 Total Non-Exempt :

Total FallSolaries $99,607 Total Solory Adjustments (1) $11,621

- Total Direct Labor, On Site (2) $111,228 Fringe Benefits @. 27.90% of Solaries $31.033 TOTAL DIRCCT LABOR, ON 51TE, PLUS FRINGE - $142,261

$142,261 j . SUBTOTAL (On-site Overheod Bose)

OVERHEAD, On-site 60.73% of Base $86.395 COST OF MONEY (Lobor) 1.1587% of Base $1.648

$88,043

> TOTAL OVERHEAD. On Site (3)

Page 25 Proposal Na 98-CLS-27101'-

OTHER DIRECT COSTS Travel Expen3es (Domsstic)

Days / #Per Mig

1. Pers. # Migs . Mig . X Mig; Cost $\ Mig Subtotal

. Experts 13 1 3 13 $1,085 $14.105 Experts 13 -1 -3 13 $1,085 14.105 3 13 $1,085 14,105 Experts 13 1 4 12 $1,250 ' 15,000

. Experts ' :12 1

$57,315 4 10 $1.250 $12,500

. Inv. 10 1 4 3 $1,250 3,750 -

Dissemin 3 1

$16,250 3 4 3 $1,250 $3,750 Stoff. 1 3 4 3 $1,250 3,750 Stoff 1 5 2 $1,415 2,830 Stoff 2 1 2 4 2 $1.250 2,500

' Stoff -1

$12,830

$86,395 Totof Domestic Travel Travel Expenses (Intemational)

Experts Fore From To #Pers #Mtg. R/T Subtotals .

Europe DC 3 1 $1,500 $4,500

$4,500 Stoff.

Fore From To #Pers # Mig. R/T

.DC Europe 1 1 $1,200 . $1,200

$1,200

- Experts PJr Diem #Doys #Pers #Mtg. Rote DC 5 3 1 $168 $2,520

$2,520 Stoff Ptr Diem - #Doys #Pers #Mtg. Rote

. Cambridge 5 1. 1 $180 $900

$900 TotalInternationalTrovel ,

$9,120 TotalTrovel $95,515 Proposal No 93 CLS-27101 Page 26 1

Other Cests R: ports and Stationery (4)

Moster Manuscript 1 copies $1,120.71 Report Prod. (5) 200 copies @ $60.91 $12,182 Stat; onery and Envelopes $304.54

. Total Reports and Stationery $13,608 ,

' Photocopies (6) $113 /mo $ 1,351 Pastoge and Delivery

)

Project . $115 /mo $1,380 Report disseminations 200 @ $3.95 - $790 Technology / Communications .

Long Distance Telephone $75.00 /mo $900 f Tel. Equip. Charge (7) $170.01 /mo $2,040 Fox, Modem Analog Lines

)

$5.91 /mo $71 l Technology Services (8) $726.06 /mo $8,713 Cost of Money $16.64 /mo $200 Office supplies $100 /mo $1,200 Meeting Expenses $8,364 Rote # Pers. #Doys Woods Hole Facility Us $24 17 2 $816

- Woods Hole Meols $20 17- 2 $680 Beckmon Ctr. Meols $23.75 1.7 2 $808 Books and Periodicols (e.g., newsletters, interlibrary loon) $400 Tctal Other $39,017 TOTAL OTHER DIRECT COSTS $134,532 SUBTOTAL $364,836 General & Administrative Costs 18.58% of Net Direct Labor. Overhead, and Direct Costs. $67,787 Cost of Money- 0.1154% of Net Direct Labor. Overheod, and Direct Costs. $421

' TOTAL GENERAL AND ADMINISTRATIVE COSTS (9) $68,208 TOTAL ESTIMATED COST $433,044 Amount Requested from EPA $433,044 11 is requested that the award will provide for payment vio Pool Agreement, Letter of Credit, or electronic tronsfer.

l l

Proposal No. 98 CLS.27101 - Page 27

. . . . - . _ - . - . . - . . . . . ~ , _ -. - _ .._ - ~ -.. .. - . . _ _ - - -. .

A FOOINOTES ,

l. An onnuol odjustment is applied to the solory base to provide for merit increosos that will be awarded during the performance period of ony oword resulting frnm this

. proposo!. The effective dote for estimating such odjustments is May I for those progroms conducted under the " Spring Schedule" units and October i for those programs conducted under the "Foll Schedule" units.

2.: Direct Labor includes on occruol for personal leave, holidoys. ond other leave, such as

. jury duty and military service, at a rate of 18.2%. . ,

3. . The total on-site overhead rate includes o focilities capitol cost of money factor.

The total off-site overhead rote includes a facilities capitol cost of money factor,

' The NRC onnvolly draws upon more than 9.000 volunteer scientists.

engineers, and other professionals, largely from universities and industry.

Plocing the volve of these donoted services in the Overhead base would result in significantly reduced Overhead and G&A rotes. ,

Moste< Stationery ond Monuscrct keports Envelopes

4. Reports and Stationery Estimated report production (copies) 200 Estimated report per copy cost 5LM .s. $60.00 $300.00

' NAP cost of money factor 1.51.W/; % y a .- 1.51330% 1.51330%

Estimoted total report charge per copy $1.12C" $.'O.9 )

Estimated totol report chorse $1.120 5: le2.00 - $304.54

- The reports cost of money is calculated by multiplying the total cost of producing reports by the cost of money factor. ,

5. Executive Order 12832 provides the authority for NA$ to reproduce +

ond disseminate Academy reports to the public os needed and therefore we have included in our estimate of costs on omount projected to cover the cost of producing and disseminctng reports for this activity, i

6.. Copying Estimated pages 29.750 R A per Page 50.0445 /pg ,

Copying cost of money factor 50.0009 /pg

" Estimated copying chorges $1.351 i

Proposal No 98 CLS-271-01 Page 28

r~ l p I Copying is $stimot5d on o monthly basis Ine total estimated copying Chorge is

.- ' derived by dstermining the total estimated number of poges tnot might be reproduced based on similar projects undertaken by the NRC and multiptving by the negotioted per Copy rate. The negotiated per Copy foie includes a negotioted per copy cost of money factor. )

i

)

l 7, Communications

[ . .

, Prorated Telephones 1,8i

~ (Totol Full-time Equivotent employees reflected in estimated saloned staff I? ond on-site borrowed personnet percent of time in Direct Labor section of estimate.)

Total basic equipment charge, Digital $43.35 Basic equipment Chg. Digital $40.98 /bi-wk Tel. cost of money factor, per phone $2.3704 /bi-wk

[ (not opplied to Long Distonce) t a Telephone equipment chorge eQuois Proroted Tele;> hones times the total basic equipment charge, biweekly, times the number of pay periods covered by the estimate.

' Estimoted use of Foxwse 20 Totof basic equipme-* ~ m 4-- - -

$13.65 Bosic equipment ch; - * * - - $12.90 /bi wk Analog cost of moner .:; , .: $0.7481 /bi-wk l

Fox / Modem lines are su . . ; OC: s *,in other projects.

L 8.. Tecnnology .

Proroted PCs . l.81 (Total Full-time Equivoient empiovees 'e' ected in estimated soloried stoff

- ond on site borrowed personnel percent of time in Direct Labor section of estimate.)

TotalTechnology Services charge $189.38 Technology Services chg. per PC $185.14 /bi-wk Tech, cost of money factor per PC $4.24 /bi-wk Technology services charge equals Prorated PCs times the total basic equipment chorge, biwe6kly, times the number of poy periods covered by

-- the estimate; 9; he use of olt rates in this proposal hos been opproved by the Administrative Contracting Uficer, Office of Novol Research, to ossist sponsors in occurate forword pricing. The NRC

' ir' direct rates are negotioted with the Office of Novo! Research on o yearly bosis.

I The proposed rotes are fixed rete carry forword which meons that the rotes may change

-. for subsequent NRC fiscol years (July I through June 30). The NRC must propose using ,

(l the rotes in effect of the time of the proposol. However, for contract billing purposes,

' the rotes proposed moy change for subsequent NRC fiscal years and it is understood R I fnot any Contre *% cily stipulated indtect rote would be modified in oCCordonCe, with ony revised negohoted indrect rates. Incirect rates include the corresponding negotioted rote ogreement cost of money factors.

' Proposal No 98 CLS 27101 Page 29

- , - , _ . ~ . . . - . .

Rote Table: Rate Before Cost of Cost of Money NAS FY 90 RATES Money Additive TotalRote 33.99 % 0.1394 % 34.1294%

Offsite Overhead

• 60.73% 1.1587% 61.8887%

Regular Ovemead :

1.95% - 0.0087% 1.9587%

Flow-through Admin 18.58% .0.1154 % 18.6954%

G&A

$0.0445 , 50.0009 $0.0454 Copy Center

$40,93 $2,3704 $43.35 Telephone: Digital .

$)2,90 $0.7481 $13.65 Telephone: Anolog

$185.14 $4.2428 $189.38 Technology 18.2% - 18.2%

Leovo 27.9% - 27.9%

Fringe NAP

- IS33%  !.5133%

Poy Periods 26 ' 2.16667 per month Woods Hole facility Use $24 per doy Woods Hole Meols $20 per person perdoy Beckmon Center Meals $23.75 per person. per day e

a i

!~

ProposalNo 98-CL.5-27101 Page 30

I R.F. (Rick) Jostes Board on Radiation Effects 11336 Links Drive

- Research

l. National Research Council Reston, VA 20190 l National Academy of Sciences (703) 471-0419 2101 Constitution Avenue, NW E-Mail: rfjostes@aol.com Washington, DC 20418 .

(202) 334-2840 EDUCATION i B.S. Biological Science (1972), Illinois State University M.S. Biological Science (1973), Illinois State University Ph.D. Cellular Radiation Biology (1978), Colorado State University i

Postdoctoral Fellowship (1981 - with R.B. Painter), University of i Califomia, San Francisco.

RESEARCH EXPERIENCE 1981 - 1982 Assistant Professor, General Biology and Radiation j Biology, Oregon State University.

4 1982 - 1985 Assistant Research Radiobiologist, Brain Tumor Research Center, University of California, San Francisco.

1985-1986 Assistant Research Radiobiologist, Laboratory of Radiobiology and Environmental Health, University of California, San Francisco.

1986 - 1989 Research Scientist, Cell Biology Section, Biology and Chemistry Department, Battelle, Pacific Northwest Laboratories.

1989 - Nov. 281995: Senior Research Scientist, Cell Biology Section, Northwest Laboratories. Position eliminated due to Department of Energy budget cuts.

1986-Aug 1997 Staff Research Associate, Laboratory of Radiobiology and Environmental Health / Dermatology, University of Califomia, San Francisco.

1

Aug 1997- Present Senior Program Officer, Board on Radiation Effects Research National Academy of Sciences RESEARCH EXPERIENCE Recent research interests centered on the molecular basis of gene mutation using shuttle vectors, transgenic mice and the hprt locus in mammalian cells of various types and origin. Other interests include various aspects of DNA damage and repair as determined by cell survival, DNA strand break analysis and cytogenetic techniques. Current projects involve various studies with human DNA-repair-deficient cell lines (Xeroderma pigmentosum).

TEACHING EXPERIENCE Assistant Professor at Oregon State University (1981-1982). Member of the staff teaching General Science 101,102, and 103 (Biology lecture and laboratory). Participated in and graduated from the " College and University Teachers" program. Taught courses in Radiation Biology, Advanced Radiation Biology, and developed a Cellular Radiation Biology laboratory course. Recent experience (1986 - 1995) includes two programs involving hands-on supervision in the laboratory of high school teachers (TRAC program) university students (SERS program) and one postdoctotal fellows SCIENTIFIC SOCIETY ME\1RERSHIPS Radiation Research Society Environmental Mutagen Society Genetic and Environmental Toucology Association of Northem Califomia.

American Association for the Adsancement of Science RECENT GRANT SUPPORT (Programs terminated by DOE due to funding cuts, Oct.1,1995)

P.I. -

Department of Energy: Office of Health and Environmental Research Project Grant # 12486 Mechanisms of Radon-Induced DNA Damage (Contract DE AC06-765RLO- 1850). '

PI: R. F. Jostes S197,400 / Year P.I.

Department of Energy: Office of Health and Environmental Research Project Grant # 21366 Correlation of DNA Strand Breaks and Altered Growth of Human Cells Exposed to

< Individual Alpha-particle Tracks.

(Contract DE AC06-765RLO- 1850).

Co-PI (with John Nelson, retired): R. F. Jostes $242,000 / Year Co-Investigator 2

V ,

( .

Department of Energy: Office of Health and Environmental Research Project Grant # 13816

' Biological Effectiveness of Radon Alpha Particles.

(Contract DE AC06-765RLO- 1850 PI: L. Braby).

PEER REVIEWED PUBLICATIONS l .

l - Jostes, R. F., Jr. (1975) A method for determining the chromosome numbers of parthenogenic psocids(insecta: Psocootera),Cytologia,40,553-555. .

Jostes, R. F.,'Jr.; W. C. Dewey; and L. E. Hopwood (1977) Mutagenesis by fluorescent light in mammalian cell cultures Mutat. Res.,42,139-144.

l Jostes, R. F., Jr.; L. E. Hopwood; and W. C. Dewey (1978) The dependence of mutation frequency on 8-azaguanine concentration in control and irradiated CHO cells, Mutat. Res., 50, 433-440.

Jostes, R. F., K. M. Buschnell; and W. C. Dewey (1980) X-ray induction of 8-azaguanine l resistant mutants in synchronous Chinese Han: ster ovary cells, Radiat. Res., 83,146-161.

l l ' Jostes, R. F., Jr. and R. B. Pamter. t WN u Evidence for repair of premutational damage from split X-ray doses, Radiat. Res., M. 5mi.5w.

! Jostes, R. F. (1981) Sister-chromatid exchanges but not mutations decrease with time in arrested l

Chinese hamster ovary cells after treatment with ethylnitrosourea., Mutat. Res.,91,371-375.

! Jostes, R. F., L. Samson, and J.1-. Schwanz (1981) Kinetics of mutation and sister-chromatid exchange induction by ethyl methanesulfonate in Chinese hamster ovary cells, Mutat. Res.,91, 255-258. 'I i

Jostes, R. F., M. E. Williams, M. H. Barcellos-Hoff, T. Hoshino, and D. F. Deen (1985) 9L rat brain tumor spheroid growth delay after single and split dose X-ray treatment, Radiat. Res.,102, ..

I82-189.

l- Jostes, R. F., M. E. Williams, and D. F. Deen (1985) The effect of single and split dose p spirohydantoin mustard treatment on the growth response of 9L rat brain tumor spheroids, Eur. J.

l- . Cancer Clin. Oncol.,21,975 979.

H i L Morgan, W. F., M. C. Djordjevic, R. F. Jostes, and G. E. Pantelias (1985), Delayed repair of

-DNA single. strand breaks does not increase cytogenetic damage, Int. J. Radiat. Biol.,48,711- 1 721.

!= Jostes, R. F., Jr. and D. F. Deer (1986) Double'elution analysis of cross-link formation and repair in cycling and noneycling spheroid cells, Cancer Res. 46,2352-2355.

3

._ _ . _ y l

'Reese, J. A., R. F. Jostes, and M. E. Frazier (1988) Exposure of mammalian cells to magnetic or l electric fields does not cause DNA single-strand breaks or cross-linking, Bioelectromagnetics 9, l l- 237-247.

Jostes, R. F., J. A. Reese, J. E. Cleaver, M. Molero and W. F. Morgan (1989) Quiescent human l . lymphocytes do not contain DNA strand breaks detectable by alkaline elution, Experimental

. Cell Res.,_182,513-520, l .

V .

. Frazier, M.E., J. A. Reese, J. E. Morris, R. F. Jostes and D. L. Miller (1990) Exposure of '

Mammalian Cells to 60-Hz Magnetic or Electric Fields: Analysis for DNA Repair ofInduced, l . Single-Strand Breaks, Bioelectromagnetics, 11,229-234. '

l L Jostes, R. F., T. E. Hui, A.C. James, F. T. Cross, J. Mencl, J. L. Schwartz, J. Rotmensch, R..

! Atcher, H. H. Evans, G. Bakale, and P.S. Rao (1991)1n vitro Radon Exposure of Mammalian Cells: Dosimetric Considerations, Radiat. Res.,~ 127,211-219.

L Wolff, S..' R. F. Jostes, Jr., F. T. Cross, T. E. Hui, V. Afzal, and J. K. 'Wiencke (1991) Adaptive Response of Human Lymphocytes for the Repair of Radon-induced Chromosomal Damage, Mutat.Re> . 250.299 300. .

Schw m. J. L.. J. Rotmeseh, R. W. Atcher, R. F. Jostes, T. E. Hui, F. T. Cross, D. Chen, S. l Carpenter. H. H. Evans. J. Mencl, G. Bakale and P. S. Rao (1992) Interlaboratory comparison of different alpha radon sources: cell survival and RBE, Health Phys.,62 (5),458-461.

Lutze.1. 11. Wmegar. R. A., Jostes, R. F., Cross, F. T., and J. E. Cleaver (1992) Non- 5 homologous recombination in human cells: its role in radon-induced deletions, Cancer Res.,53

.(18),5126-5129. .

L Jostes, R. F., E. W. Fleck, R. A. Gies, T. E. Hui, T. L. Morgan, J. L. Schwartz, J. K. Wiencke, ,

. and F. T. Cross. Cytotoxic, Clastogenic and Mutagenic Response of Mammalian Cells Exposed in vitro to Radon and it's Progeny, in Proceedings of the 29th Hanford Symposium on Health and ,

the Environment - Indoor Radon and Lung Cancer: Reality or Myth? Part 2, F. T. Cross (ed.), ,

. Battelle Press, Columbus, Ohio, pp.555-568,1992.

Jostes, R. F., T. E. Hui, and F. T. Cross (1993) Use of the single cell gel technique to support hit probability calculations in mammalian cells exposed to radon and radon progeny, Health Phys.,

64 (6),675-679.

Hui, T. E., A. C. James, R. F. Jostes,'J. L. Schwartz, K. L. Swinth, and F. T. Cross (1993)

Evaluation of an alpha probe detector for in vitro cellular dosimetry, Health Phys., 64 (6), 647-652.

Evans, H, H., J. Mencl, G. Bakale, P. S. Rao, R. F. Jostes, T. E. Hui, F. T. Cross and J. L.

Schwartz (1993) Interlaboratory comparison of the effects of radon on L5178Y cells

Dose contributiva of radon daughter association with cells, Radiat. Res., 136,48-56.

4

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Wolff, S., V. Afzal, R. Jostes, and J. K. Wiencke (1993) Indications of repair of radon-induced chromosome damage in human lymphocytes:an adaptive response induced by low doses of x l rays, Environ. Health Perspect., 101 (3),73-77.

Brooks, A. L. , M. A. Khan, R. F. Jostes and F. T. Cross (1993) Metaphase chromosome aberrations as markers of radiation exposure and dose, J. Toxicol. Environ. Health,40,277-288.

Jostes, R.F., E. W. Fleck. G. L. Steigler, T. L. Morgan, and F. T. Cros$ (1994), Southem and PCR Analysis ofHPRT Mutations Induced by Radon and it's Progeny, Radiation Research,137, 371-379.

Khan, M. A. , F. T. Cross, R. Jostes, E. Hui, J. E. Morris, and A. Brooks, (1994) Micronuclei Induced by Radon and its Progeny in Deep-Lung Fibroblasts of Rats In Vivo and In Vitro, Radiat. Res., 139,53-59.

l l

Brooks, A. L. , M. A. Khan, A. Duncan, R. F. Jostes, R.L. Buschbom, and F. T. Cross (1994)

The effectiveness of radon relative to 60Co gamma rays for induction of micronuclei in vitro and in vivo, Int. J. Radiat. Biol., 66 No. 8, 801 -808.

Jostes, R. F. Genetic, cytogenetic, and carcinogenic effects of radon-a review (1996) Mutation Research,340,125-139.

Miller, R.C, M. Richards, D. J. Brenner, E. J. Hall, R. Jostes, T. E. Hui and A. L. Brooks (1996)

- The Biological Effectiveness of Radon-Progeny Alpha Particles. V. Oncogenic Transformation from monoenergetic Accelerator-Produced Alpha Particles Compared with Polyenergetic Alpha Particles from Radon Progeny. Radiation Research, 146.75-80.

SUBMITTED Albertini, Richard J., L. Scott Clark, Janice A. Nicklas, J. Patrick O'Neill, T. Edmond Hui, and Rick'Jostes. Radiation quality affects efficiency ofinduction and' molecular spectrum of hprt mutations in human T-cells. Submitted to Radiation Research.

PUBLISHED ABSTRACTS Jostes, R. F., Y. Sano, L. Marton, and D. Dean. 1983. The effect of BCNU treatment on survival and SCE induction in sequential cell layers of 9L brain tumor spheroids. Environ.

Mutat.1: 380.

l Jostes, R. F., M. H. Barcellos-Hoff, M. E. Williams, and D. F. Deen. 1984. Growth delay and survival aller single and split dose X-ray treatments. Strahlentherapie 160: 63.

5 i

Jostes, R. F., M. E. Williams, and D. F. Deen.1984. Single and split dose effects of spirohydentoin mustard on the 9L brain tumor spheroid. Strahlentheranie 160: 63.

Jostes," F., R. Rausch, B. M. Miller, L. B. Sasser and J. C. Dacre. 1989. Genotoxicity of Lewisite in Chinese Hamster Ovary cells. Ihe Toxicolocist .12: No.1,232.

Jostes, R. F., R. A. Gies, T. L. Morgan, E. W. Fleck, K. P. Gasper, and F. T. Cross. 1989.

Molecular Analysis of Radon-Induced Mutants. Environmental and Molecular Mutacenesis 14:

Supp.15.

Jostes, R. F., T. L. Morgan, R. A. Gies, E. W. Fleck, K. P. Gasper, and F. T. Cross.1990.

Molecular Analysis of Radon-Induced Mutants. Joumal of Cell. Bio. Supp.14A,55.

Jostes, R. F., Layton, A. D., F. T. Cross, L. H. Lutze, G. L. Steigler, and L. C. Stillwell. (1995)

Sequence analysis ofLacImutations obtained from lung cells of control and radon-exposed Big Blue Transgenic Mice. Environmental and Molecular Mutacenesis.vol.25. suoni. 25: 25.

PACIFIC NORTHWEST LABORATORY PUBLICATIONS Jostes, Jr., R. F., R. J. Rausch and L. B. Sasser.1989. Toxicology studies oflewisite and sulfur mustard agents: Genetic toxicology of sulfur mustard (HD) in Chinese Hamster cells. Final Report for the U.S. Anny Medical Research and Development Command. PNL-6916 Jostes Jr., R. F., R.J. Rausch, and L. B. Sasser. 1989. Toxicology studies on lewisite and sulfur mustard agents: Genetic toxicology oflewisite (L)in Research and Development Command.

PNL-6922 i

l ARMY PUBLICATIONS i

Weller, R. E., J. E. Morris, B. J. McClanahan, D. Mahlum and R. F. Jostes. 1987. Evaluate the Dennal Toxicity of Nitrate Compounds and Liquid Gun Propellants. Army gram. Fort Detrick, Frederick, Maryland, September 15-17.

PRESENTATIONS SINCE 1990 Jostes, R. F., J. K. Wiencke, V. Afzal, S. Wolff, and F. T. Cross. In Vi o adon-Induced Chromosomal Damage in Human Peripheral Blood Lymphocytes. Presented at the 38th Annual Meeting of the Radiation Research Society, New Orleans, LA, April 7-12,1990.

Jostes, R. F., E. W. Fleck, R. A. Gies, T. E. Hui, T. L. Morgan. J. L. Schwartz, J. K. Wiencke and F. T. Cross. Cytotoxic, Clastogenic and Mutagenic Response of Mammalian Cells Expos ~ed in vitro to Radon and it's Progeny. Presented at the 29th Hanford Symposium on Health and the 1

6

t Environment - Indoor Radon and Lung Cancer: Reality or Myth? Richland, WA, October 15-19,

! 1990.

Jostes, R. F., T. E. Hui, R. A. Gies, and F. T. Cross. Use of the single cell gel technique to support hit probability calculations in mammalian cells exposed to radon and radon progeny.

Presented at the 40th Annual Meeting of the Radiation Research Society, Salt Lake City, Utah.

March 14-18,1992.

Jostes, R. F., T. E. Hui, A. L. Brooks, and F. T. Cross. Use of the singl'e cell gel technique to support hit probability calculations in mammalian cells exposed to radon and radon progeny.

Presented at the 6th International Conference on Environmental mutagens, Melbourne Australia February 21-26,1993.

Jostes, R. F., T. E. Hui, A. L. Brooks, and F. T. Cross. Southern blot and PCR Analysis of HPRT Mutations Induced by Radon and it's Progeny. Presented at the 6th International Conference on Environmental mutagens, Melboume Australia February 21-26,1993.

Jostes, R. F., T. L. Morgan. E. W. Fleck. G. L. Steigler. and F. T. Cross. Southern and PCR

- Analysis of HPRT Mutations induced by Radon and it's Progeny. Presented at the 41st Annual Meeting of the Radiation Researen society. Dallas. Texas March 20-25,1993.

Jostes, R. F., Layton, A. D., F. T. Cross. L. H. Lutze, G. L. Steigler, L. C. Stillwell,and R. F.

Jostes. Sequence Analysis ol'Laci Niutations Obtained From Lung Cells of Radon-exposed Big Blue Transgenic Mice. Presented at the 42nd Annual Meeting of the Radiation Research Society, Nashville, TN April 29 W .:.1994 Layton, A. D., F. T. Cross, L. H. Lut/c. G. L. Steigler, L. C. Stillwell.and R. F. Jostes. Sequence Analysis of Laci Mutations Obtained From Lung Cells of Radon-exposed Big Blue Transgenic Mice. Presented at the 25th Annual Meeting of the Environmental Mutagen Society, Portland, OR 1994.

Jostes, R. F., Layton, A. D., F. T. Cross, L. H. Lutze, G. L. Steigler, and L. C. Stillwell.

Sequence analysis of LacI mutations obtained from lung cells of control and radon-exposed Big Blue Transgenic Mice. Presented at the 26th Annual Meeting of the Environmental Mutagen Society, Saint Louis, MO 1995.

OTHER ACTIVITIES Chaired and organized workshop entitled " Genetic Toxicology ofIn Vitto Radon Exposure."

Finh International Conference on Environmental Mutagens, Cleveland, OH, July 10-15,1989.

Member: Membership committee, Radiation Research Society, 1989-1992.

7

a Member: Organizing committee, Twenty-ninth Hanford Symposium on Health and the Environment. " Indoor Radon and Lung Cancer: Reality or Myth? To be held in Richland, WA, October 16-19,1990.

Reviewer NCI-RFA entitled " Molecular Analyses of Radiation-Induced Genetic Damage."

Bethesda, MD November 24-26,1991.

Invited speaker, Sixth International Conference on Environmental Mutagens, Melboume, Australia, February,1993.

June,1996 l

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