Positions & Resolutions

Conference of Radiation Control Program Directors, Inc.

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CRCPD RESOLUTION

Relating to Reduced Protection from X-Ray Exposure Resulting from the Proposed Revisions to the Federal Performance Standard for Diagnostic Equipment and their Major Components (FPS).

WHEREAS: X-rays represent the largest source of man-made ionizing radiation exposure;

WHEREAS: The purpose of Public Law 90-602, The Radiation Control for Health and Safety Act of 1968, was to protect the public from unnecessary exposure to radiation from electronic products;

WHEREAS: The proposed revisions to 21 CFR 1020 are in some cases based on outdated studies which no longer reflect the current usage of radiation producing machines in the United States;

WHEREAS: State Radiation Control Programs cooperatively inspect and, through state standards, enforce the requirements of the FPS;

WHEREAS: States are prohibited from adopting machine-based standards which are more restrictive than the FPS;

WHEREAS: The installation of non-certified components has continued beyond the expectation stated in the cost-benefit analysis used to justify the requirements under 21 CFR 1020, resulting in the continuation of unnecessary x-ray exposures to the public;

WHEREAS: The current FPS is difficult to interpret the responsibilities of assemblers and the enforcement for the regulatory agencies;

WHEREAS: The current FPS only addresses part of the usage of x-rays in the healing arts, leaving a void in the manufacturing standards for therapeutic equipment;

NOW BE IT RESOLVED : Any change to the FPS shall ensure that radiation exposures to both the public and to machine operators are maintained as low as reasonably achievable;

NOW BE IT FURTHER RESOLVED: Any change to the FPS shall result in the further reduction of unnecessary radiation exposures;

NOW BE IT FURTHER RESOLVED: Elimination of any existing criteria shall be based on current, validated data;

NOW BE IT FURTHER RESOLVED: Revisions to the FPS shall be drafted in consultation with representatives of State Radiation Control Programs;

NOW BE IT FURTHER RESOLVED: There shall be a mandatory phase-out of the installation of non-certified components;

NOW BE IT FURTHER RESOLVED: FDA shall pursue the refinement and clarification of the FPS; and

NOW BE IT FURTHER RESOLVED: FDA shall pursue the incorporation of standards for therapy radiation producing machines.

Accepted by CRCPD Membership May 5, 1990
Signed by Charles M. Hardin, Executive Director