Answer to Question #2547 Submitted to "Ask the Experts"

Q

Historically, was there an agency under which x-ray producing devices were first subject to regulatory authority? I have been able to determine the timeline for promulgation of x-ray protection standards, but not if some central agency existed with regulatory powers (for example, the AEC [Atomic Energy Commission]).

A

In reviewing the historical literature on x-ray exposures and regulation, it appears that in 1978 Federal Guidance was issued to federal agencies for diagnostic x rays (see 43 Federal Register 4377, 1 February 1978). Authorizing statutes for these regulations were from Executive Order 10831 and Public Law 86-373 (effective 23 September 1959), which added section 274 to the Atomic Energy Act of 1954, and the President's Reorganization Plan No. 3 of 1970.

In addition, the Radiation Control Safety Act of 1968 (effective 18 October 1968), Public Law 90-602; the Public Health Service Act; and the Federal Food, Drug, and Cosmetic Act were also affected by the issuance of this Federal Guidance.

Under the Radiation Control for Health and Safety Act, the Public Service Act, and the Federal Food, Drug, and Cosmetic Act, the Assistant Secretary for Health in the Department of Health in the Department of Health and Human Services (HHS) (which has been delegated to the Food and Drug Administration), was given the responsibility to develop a program of radiation protection which, in part, included research and training concerning radiation hazards, recommendations for radiation users, advice to States, information for the public, performance standards for electronic products that emit radiation, and regulations for the sale, distribution, and use of medical devices. These programs are described in 21 CFR 1000 to 21 CFR 1050. Additional information may also be found on the Center for Devices and Radiological Control website.

Cynthia G. Jones, PhD