ML20236H877
| ML20236H877 | |
| Person / Time | |
|---|---|
| Issue date: | 06/08/1998 |
| From: | Callan L NRC OFFICE OF THE EXECUTIVE DIRECTOR FOR OPERATIONS (EDO) |
| To: | |
| References | |
| SECY-98-130, SECY-98-130-01, SECY-98-130-1, SECY-98-130-R, NUDOCS 9807070400 | |
| Download: ML20236H877 (8) | |
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POLICY ISSUE June 8.1998 (NEGATIVE CONSENT) SECY-98-130 ERB. The Commissioners FROM L. Joseph Callan Executive Director for Operations
SUBJECT:
ADDITIONAL FUNDING TO MAKE U.S. NUCLEAR REGUI.ATORY COMMISSION DOCUMENTS ON HUMAN RADIATION EXPERIMENTS AVAILABLE ON WORLD-WlDE WEB PURPOSE:
To obtain Commission approval of the staff's proposal to transfer an additional $55,000 to Argonne National Laboratory (Argonne or ANL), a contractor for the Human Radiation Interagency Working Group, to complete the task of making Nuclear Regulatory Commission (NRC) documents related to human radiation experiments available to the public on the World Wide Web (WWW) The attached letter from the Department of Energy (DOE)' Deputy Assistant Secretary for Health Studies encourages the Commission to join the other Federal agencies in completing the public database.
BACKGROUND:
As discussed in SECY 97-064, Executive Order 1289i established the Presidential Advisory Committee on Human Radiation Experiments (ACHRE) to review human radiation experiments and to provide advice and recommendations to a cabinet-level Human Radiation Interagency Working Group. NRC was not a member of the cabinet-level Group, but did provide relevant documents and information to the Group and to the ACHRE. The Group established a site, on the WWW, to make the full text of the documents retrieved by the Group, and used by ACHRE in its review, available. In 1997, the Group asked NRC to provide $50,000 to place NRC documents on the Website. ,
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l CONTACT: Paul F. Goldberg, NMSS/IMNS NOTE: TO BE MADE PUBLICLY AVAILABLE (301) 415-7842 WIEN THE FINAL SRM IS MADE AVAILABLE ~ \ ,'
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The Commissioners 2 in SECY 97-064, the staff requested Commission approval to transfer $50,000 to ANL, to put NRC documents on human radiation experiments into electronic format and make them available, to the public, on the WWW. In a Staff Requirements Memorandum dated April 15, i 1997, the Commission did not object to the staff proposal and added that the staff should not j exceed $50,000 without specific Commission approval. Tae staff transferred the $50,000 to
. ANL. ANL began work in September 1997 and by early January had expended the $50,000.
With NRC's $50,000, ANL scanned more than 12 boxes (approximately 39,000 pages) of NRC documents; processed about 10 boxes tnrough optical character recognition (OCR) software; j audited 4 boxes to enhance low-quality images; indexed documents for 12 boxes; and j constructed the source database for 12 boxes. Essentially, ANL provided NRC with $50,000 l worth of services between September 1997 and January 1998 by preparing 12 boxes of NRC humar. radiation experiments documents for the Website.
Although NRC did benefit from not having to pay startup and development costs for the Website and the document-processing operation, the staff transferred a larger volume of documents i than originally estimated (21 boxes rather than 15) and ANL's costs per box for processing the l documents were higher than originally estimated. In addition, ANL had hoped that the
- l. Department of Defense (DOD) would be able to absorb the excess cost for NRC documents.-
l DOD has allowed ANL to use $9000 of DOD funds to process NRC documents. However, l DOD has identified more of its own documents than originally expected and will be unable to l cover additional costs beyond the $59,000 already spent on the NRC documents.
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As a result, ANL advised NRC that it would be unable to complete processing of NRC -
documents without additional funds, totaling $55,000, from NRC. DOE has sent the attached letter urging NRC to provide the additional funds necescary to complete the effort for NRC documents.
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DISCUSSION-The availability of the documents in electronic form on a Website, with the system's extensive indexing and search capability, would make the documents widely and conveniently available,
- j. . and would spare NRC the necessity of providing documents in response to requests or making the documents available in the Public Document Room. Since the system has been developed,
- tested, and is already operational, NRC benefits from not having to pay a share of startup costs l for the system. ]
L . As part of a series of activities under the President's " Openness in Govemment initiative," the j availability of documents related to human radiation experiments has a high govemment-wide prionty. NRC has the third-largest collection of documents of the Federal agencies involved, and the Group wants to assemble a comprehensive database to provide a complete and clear j view of radiation experimentation.
. The additional $55,000 would allow' ANL to complete the scanning, OCR processing, auditing, indexing, and source database construction for the additional boxes. In addition, it would allow ANL to perform quality assurance for the entire collection of 21 boxes and to post the entire ,
collection on the Website.' Based on work performed to date, the contractor has clearly identified the scope of work and the level of effort needed to complete the project. The staff 1
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- y. The Commissioners 3 i
l has reviewed the contractor's proposal and considers it reasonable. The staff has sought and obtained verbal assurances from the contractor that ANL will be able to complete the work for
$55,000. If the Commission approves the additional funding, the staff will obtain contractual l
commitments from ANL to complete all remaining work without further requests for funding. If NRC does not provide the additional funds needed, ANL will not be able to place the NRC document collection on the Website, likely leading to more inquiries, including requests under the Freedom of Information Act (FOIA), to NRC.
The staff seeks Commission guidance conceming three options for dealing with the NRC documents related to human radiation experiments:
Option 1: Provide no additional money for document processing or posting the
- documents on the Website.
Option This option would allow NMSS to spend the funds on other needs. The $50,000 spent to date by NRC has been expended and cannot be recovered. Under this option, the goal of making documents available would not be accomplished. NRC would stand out as the only agency of those involved not to make its documents available on the Website and would have to expend agency resources to place documents in the Public Document Room and to respond to requests for information, including frequent FOIA requests, about human radiation experiments.
! Option 2 Provide the requested funding.
i Option This option would complete the interagency database and place NRC documents with l
those of the other Federal agencies. It would allow NRC to avoid expending additional agency resources on information requests related to human radiation experimentation. This altemative !
l could be accomplished by reprogramming from within the NMSS budget. This would be the l surest, quickest and most cost-effective way of accomplishing the goal of making the l documents available and ensuring that the funds spent to date are not wasted. I i
Option 3: Provide approximately $12,000-15,000 now to ANL to post the documents already processed on the Website.
Option For the NRC documents that have already been scanned into digitd format, this option would make those doct nents available on the Website. This approach would only partially
, achieve the project's original goal, by making slightly more than half of NRC's total volume of l human radiation experimentation records available on the Web. This option would require a smaller immedinte expenditure of funds than Option 2 and would not single out NRC as the sole agency without documents on the Website. The staff understands from ANL that they would require approximately $12,000-$15,000 to post the already-digitalized documents on the Website. If the Commission selects this option, the staff will obtain contractual commitments from ANL to post all of NRC's human radiation experimentation documents, that are already in electronic format, on the Web without further requests for funding.
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s k The Commissioners
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l RESOURCES-Regardless which option is selected, no additional resources will be required as funds will be reprogrammed from other, lower-priority activities. There will be no significant impact on
(. existing budgeted activities. '
1 REQUESTED COMMISSION ACTION The staff recommends Option 2: using existing NMSS funds to immediately transfer the additional $55,000 dollars requested by the contractor, in order to complete the work requested l by the Interagency Group.
COORDINATION The Office of the General Counsel has reviewed this paper and has no legal objection.
The Office of the Chief Information Officer has reviewed the Commission paper for information technology and information management implications and concurs in it. The Office of the Chief Financial Officer has reviewed this paper for resource implit.*tions and has no objection to the transfer of funds.
L J seph Callan b
E ive Direct for Operations Attachments:
- 1. Ltr. from P. Seligman, DOE to L. Joseph Callan, dtd 3/16/98
- 2. Executive Order dtd 1/18/94' SECY NOTE: In the absence of instructions to the contrary, SECY will notify j the staff on Tuesday, June 23, 1998 that the Commission, by negative consent, '
assents to the action proposed in this paper.
DISTRIBUTION:
Commissioners ASLBP OGC CIO OIG CFO OPA - EDO 0CA Regions
'ACNW SECY 1
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Department of Energy 5 i r ,
Germantown, MD 20874 1290
>*V * # MAR 161998 Mr. Joe Callan Executive Director for Operations U. S. Nuclear Regulatory Commission Mail Stop 5E6 ,
Washington, D.C. 20555 l
Dear Mr. Callan:
I am writing to encourage the Nuclear Regulatory Commission (NRC) to fund the scanning ofits i remaining human radiation experiments documents for inclusion in the Human Radiation Experiments Information Management System (HREX). The documents in this system served as a basis for the report of the Presidential Advisory Committee on Human Radiation Experiments and are now fully accessible to the public via the World Wide Web. The Department of Energy (DOE) was the lead agency for this Cabinet level effort, and we are eager to bring it to closure.
HREX allows the public to conduct full text searches of the database and to retrieve images of original documents. Currently it has over 500,000 documents. The remaining NRC documents will complete the database. HREX will then contain all the records collected by the Federal Government during the' Advisory Committee's investigation, including, in addition to the records of DOE and NRC, records from the Department of Defense, the Department of Health and Human Services, the Veterans Administration, the National Aeronautics and Space Administration, and the Central Intelligence Agency.
The President, in a forward to the Administration's response to the recommendations of the Advisory Committee, pointed to the significant achievements made in opening Govemment and to the importance of" making information more easily available to the citizens to whom it belongs." Completion of the HREX database will contribute to this effort.
If you have any questions regarding this request, please contact Elly Melamed on 301-903 8044.
Sincerely,
( N'^"
W Paul J. Seligman, M.D., M.P.H.
. Deputy Assistant Secretary for Health Studies Pnnted with soy enk on recycled paper Attachment 1 EDO -- G980177
EXECUTIVE ORDER s
THE WHITE HOUSE Y
Office of the Press Secretary For Immediate Release January 18, 1994 EXECUTIVE ORDER I l
ADVISORY COMMITTEE ON HUMAN RADIATION EXPERIMENTS By the authcrity vested in me as President by the Constitution and the laws of the United States of America, it is hereby ordered as follows:
Section 1. Establishment. '
(a) There shall be established an Advisory Committee en !
Human Radiation Experiments (the " Advisory Committee" or !
" Committee"). The Advisory Committee shall be composed of not more than 15 memt .rs to be appointed or desigi ated by the President. The Advisory Committee shall comply with the Federal Advisory Committee Act, as amended, 5 U.S.C. App. 2.
(b) The President shall designate a Chairperson from among the members of the Advisory Committee.
Sec. 2. Functions.
(a) There has been established a Human Radiation Interagency Working Group, the members of which include the Secretary of Energy, the Secretary of Defense, the Secretary of Health and Human Services, the Secretary of Veterans Affairs, the Attorney General, the Administrator of the National Aeronautics and Space Administration, the Director of Central Intelligence, and the Director of the Office of Management and Budget. As set forth in paragraph (b) of this section, the Advisory Conadttee shall provide to the Human Radiation Interagency Working Group advice cnd recommendations on the ethical and scientific standards cpplicable to human radiation experiments carried out or cponsored by the United States Government. As used herein, " human radiation experiments" means:
(1) experiments on individuals involving intentional cxposure to ionizing radiation. This category does not include common and routine clinical practices, such as established diagnosis and treatment methods, involving incidental exposures to ionizing radiation; (2) experiments involving intentional environmental releases of radiation that (A) were designed to test human health effects of ionizing radiation; or (B) were designed to test the extent of human exposure to ionizing radiation.
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Attachment 2 1
Consistent'with the provisions set forth in paragraph (b) of a
this section, the Advisory Committee:shall'also provide advice, information, and recommendations on'the following experiments:
.(1) the experiment into the atmospheric diffusion of ky . radioactive gases and test'of detectability, : mmenly referred to as "the Green Run test," by the,former Atomic Energy Commission (AEC) and'the Air, Force in December 1949 at the Hanford
' Reservation ~1n Richland, Washingtons (2) two radiation warfare. field experiments conducted at the AEC's Oak Ridge of fice in 1948 involving gamma radiation released from non-bomb point sources at or near ground level; (3) six tests conducted during 1949-1952 of radiation warfare ballistic ~ dispersal-devices containing radioactive agents at the U.S. Army's Dugway, Utah,. site; (4) four atmospheric radiation-tracking tests in 1950 at Los Alamos, New Mexico; and I (5) any other similar experiment that may later be identified by the Human Radiation Interagency Working Group.
[*2936)
The Advisory Committee shall review experiments conducted from 1944 to May 30, 1974. Human radiation experiments undertaken after May 30, 1974, the date of issuance of the Department of H2alth, EJucatien, and Welfare ("DHEW") Regulations for the Protection of Human Subjects (45 C.F.R. 46), may be sampled to dstermine whether further inquiry into experiments.is warranted.
Further inquiry into experiments conducted after May 30, 1974, may be pursued if the Advisory ~ Committee determines, with the ferncurrence of the Human Radiation Interagency Working Group, that such inquiry is warranted.
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i (b) (1) The Advisory Committee shall determine the ethical cnd scientific. standards and criteria by which it shall evaluate l human radiation experiments, as set forth 'in paragraph (a) of I this section. The Advisory Committee shall consider whether (A) there was a clear medical or scientific purpose for the experiments; (B) appropriate medical follow-up wat a-"aacted; and (C) the experiments' design and administration adequately' met the ,
sthical and scientific' standards, including standards of informed !
i c:nsent, that prevailed at the time of the experiments and that exist today.
(2). The Advisory Committee shall evaluate the extent .to j
- which human radiation experiments were consistent with applicable
' Gthical and scientific standards as determined by the committee pursuant to paragraph (b) (1) of this section. If deemed necessary for such an assessment, the Committee may carry out a detailed rsview of experiments and associated records to the extent
=p:rmitted by law.
'(3i If' required to protect the health of individuals who l . were subjects of a htman radiation experiment, or their
! descendants, the Advisory Committee may recommend to the' Human
!: Radiation Interagency Working Group that an agency notify psrticular subjects of an experiment, or their descendants, of cny potential' health risk or the need for medical follow-up.
- -+>w.w *er .
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F-_-_-__-_-(4 ) . The Advisory . Committee may recommend - f urthe
~
as neadsd, to ensure compliance with recommended ethical and scientific standards for human' radiation experiments, g
fD (SliThe. Advisory Ccmmittee may carry out such additional .
functions as the Human'Radiatien Interagency.W:rking Group may
- from time tot time request, oSec. 3. Administration. (a) The heads of executive departments-and~ agencies shall, to the extent permitted by law, provide the Advisory Committee with such information as it may -
require for purposes of carrying out'its functions .
l (b) Members of = the Advisory Committee shall be compensated in accordance with'Fe'deral law. Committee members may.be allowed-travel expenses, including per diem in_ lieu of subsistence, to the extent permitted by law for persons serving intermittently in the government' service _(5 U.S.C.
5701-5707).
f(c) To'the: extent permitted'by law, and subject to the
- availability of; appropriations, the Department of Energy shall.
provide the Advisory Committee with such funds as may.be~
necessary for the performance of its functions.
Sec.~4.-General' Provisions. (a) Notwithstanding the
- provisions of any.other Executive order, the functions of the President under~the Federal Advisory Committee Act that are epplicable to the Advisory Committee,-except that of reporting ennually to the Congress, shall be performed by. the Hunan
'Rtdiation Interagency Working Group, in. accordance with the
' guidelines and procedures established by the Administrator of Ganeral Services.
(b) The Advisory Committee shall terndnate 30 days af ter-submitting,its_
Working Group.-
final report to the Human Radiation Interagency.
[*2937);
(c)lThis order is; intended only'to improve the internal' management of the executive branch and.it is not intended.to create any right, benefit, trust, or responsibility, substantive or procedural, enforceable-at: law.or equity by a: party.against..
the Unitedistates, Lits' agencies,.its officers, or any person.
jr WILLIAM J.'CLINTON L THE WHITE n0USE,
' January 15, 1994.
Interim Report-of'the Advisory Committee on Human Radiation-L Experiments,' October 21, 1994 I
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