[Federal Register Volume 59, Number 13 (Thursday, January 20, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Printing 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