[Federal Register Volume 59, Number 13 (Thursday, January 20, 1994)]
[Presidential Documents]
[Pages 2935-2937]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-1531]
[[Page Unknown]]
[Federal Register: January 20, 1994]
Presidential Documents
Executive Order 12891 of January 15, 1994
Advisory Committee on Human Radiation Experiments
By the authority 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 on Human Radiation
Experiments (the ``Advisory Committee'' or
``Committee''). The Advisory Committee shall be
composed of not more than 15 members to be appointed or
designated 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 Committee shall provide to
the Human Radiation Interagency Working Group advice
and recommendations on the ethical and scientific
standards applicable to human radiation experiments
carried out or sponsored by the United States
Government. As used herein, ``human radiation
experiments'' means:
(1) experiments on individuals involving intentional
exposure 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.
Consistent with the provisions set forth in paragraph
(b) of this section, the Advisory Committee shall also
provide advice, information, and recommendations on the
following experiments:
(1) the experiment into the atmospheric diffusion of
radioactive gases and test of detectability, commonly
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 in Richland,
Washington;
(2) two radiation warfare field experiments conducted
at the AEC's Oak Ridge office 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
(5) any other similar experiment that may later be
identified by the Human Radiation Interagency Working
Group.
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 Health, Education, and
Welfare (``DHEW'') Regulations for the Protection of
Human Subjects (45 C.F.R. 46), may be sampled to
determine 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 concurrence of the Human
Radiation Interagency Working Group, that such inquiry
is warranted.
(b)(1) The Advisory Committee shall determine the
ethical and scientific standards and criteria by which
it shall evaluate human radiation experiments, as set
forth in paragraph (a) of 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 was conducted; and (C)
the experiments' design and administration adequately
met the ethical and scientific standards, including
standards of informed consent, that prevailed at the
time of the experiments and that exist today.
(2) The Advisory Committee shall evaluate the
extent to which human radiation experiments were
consistent with applicable ethical 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 review of experiments and associated records
to the extent permitted by law.
(3) If required to protect the health of
individuals who were subjects of a human radiation
experiment, or their descendants, the Advisory
Committee may recommend to the Human Radiation
Interagency Working Group that an agency notify
particular subjects of an experiment, or their
descendants, of any potential health risk or the need
for medical follow-up.
(4) The Advisory Committee may recommend further
policies, as needed, to ensure compliance with
recommended ethical and scientific standards for human
radiation experiments.
(5) The Advisory Committee may carry out such
additional functions as the Human Radiation Interagency
Working Group may from time to time request.
Sec. 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.
(b) Members of the Advisory Committee shall be
compensated in accordance with Federal 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).
(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 applicable to the Advisory Committee,
except that of reporting annually to the Congress,
shall be performed by the Human Radiation Interagency
Working Group, in accordance with the guidelines and
procedures established by the Administrator of General
Services.
(b) The Advisory Committee shall terminate 30 days
after submitting its final report to the Human
Radiation Interagency Working Group.
(c) This 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 United States,
its agencies, its officers, or any person.
(Presidential Sig.)>
THE WHITE HOUSE,
January 15, 1994.
[FR Doc. 94-1531
Filed 1-18-94; 4:37 pm]
Billing code 3195-01-P