Response letter to George Marienthal, Deputy Assistant Secretary of Defense (Environment and Safety) from Mr. John Villforth, Director Bureau of Radiological Health
July 29, 1976
Mr. George Marienthal
Deputy Assistant Secretary of Defense
Environment and Safety
Department of Defense
Washington, D.C. 20301
This letter will respond to your letter of July 2,1976, to the Director of the Bureau of Radiological Health of the Food and Drug Administration requesting an exemption from the FDA radiation safety performance standard for laser products (21 CFR §§ 1040.10 and 1040.11) which becomes effective on August 2, 1976.
Under the authority delegated to me by the Assistant Secretary for
Health of the Department of Health, Education, and Welfare (21 CFR ~ 5.1), pursuant to sections 358 and 360B of the Public Health Service Act, as amended by the radiation Control for Health and Safety Act of 1968 (42 U.S.C. § 263f and 263j), I hereby exempt from the provisions of 21 CFR §§ 1040.10 and 1040.ll, and from the provisions of 21 CFR Part 1002 (except § l002.20), laser products that are used exclusively by Department of Defense components and that are designed for actual combat or combat training operations or are classified in the interest of national security.
It is my understanding that this exemption is necessary because laser products that are to be used by the military for the purposes stated above require capabilities which do not lend themselves to full compliance with all provisions of the laser standard promulgated under the Act. Your request for exemption acknowledges that in most instances the specified defense mission for which the products are intended could not be fulfilled if total compliance with the standard were required.
In recommending that your request for exemption be granted, the Bureau of Radiological Health considered the laser user safety and control proce¬dures utilized by the Department of Defense. These include: for the U.S. Army, AR 40-5, Health and Environment, 25 September 1974; AR 40-46, Control of Health Hazards from Lasers and Other High Intensity Optical Sources, 6 February 1974; TB MED 279, Control of Hazard to Health from Laser Radia¬tion, 30 May 1975; for the U.S. Air Force, AF Manual l6l-32, Laser Health Hazards Control, 20 April 1973; and for the U.S. Navy ANSI 136.1, 1973, American National Standard for Safe Use of Lasers. Additional control procedures utilized by the Department of Defense include: operator training in the safe use of tactical equipment, performing an in-depth hazard analysis of such equipment during various stages of its life cycle, a hazard analysis of training and testing sites, and routine surveys of such equipment located at military installations.
The granting of this exemption is also based upon the understanding that the Department of Defense will establish monitoring procedures to assure that (1) only laser products designed expressly for actual combat opera¬tions or combat training operations and laser products classified in the interest of national defense will be procured or manufactured by the Department of Defense pursuant to the requested exemption, and (2) the Department of Defense will maintain a permanent record of the status of all exempted laser products, including their ultimate disposition. The products will not be disposed of through excess or surplus property channels without advance authorization by the FDA.
As a further condition of this exemption, the Department of Defense has also agreed to provide an annual report to FDA summarizing the internal records maintained on the exempted products, identifying types of laser products and manufacturers. Furthermore, Department of Defense procurement specifications for such exempted products will include, to the extent practicable, the radiation safety provisions of the applicable Federal standard (21 CFR 1040.10; 1040.11) unless adequate alternative controls are to be provided by the Department of Defense. Any substantive amendments to the radiation safety procedures enclosed with your letter of July 2,1976 will be submitted to the FDA for review.
All exempted products are also to be clearly identified either by the label set forth below, or by other means;
This electronic product has been exempted from FDA radiation safety performance standards prescribed in the Code of Federal Regulations, Title 21, Chapter I, Subchapter J, pursuant to Exemption No. _________ issued on ________. This product should not be used without adequate protective devices or procedures.
We request, as a term of this exemption, that the Department of Defense list in the annual report to this Agency all exempted products which are identified by a means other than by the above label, and provide detailed information as to the alternative means of identification provided, and the bases for such alternative means of identification.
This exemption is granted upon the understanding that all of the above commitments, set forth in your letter of July 2. 1976, are fulfilled by the Department of Defense. The exemption may be withdrawn or amended if any of those terms are not adhered to, or if other information becomes available that indicates that the public health and safety are not adequately protected from electronic product radiation emitted by products exempted pursuant to this authorization.
This exemption shall be referred to as Exemption No. 76EL-OlDOD issued on July 26. 1976, and any correspondence concerning its implementation should be directed to the Director of the Bureau of Radiological Health. A copy of your July 2. 1976 letter requesting the exemption (with attachments) and this notice of approval will be filed in the FDA Public Records and Documents Center, Room 4-62, 5600 Fishers Lane, Rockville, MD.
We appreciate your cooperation in this matter.
Acting Commissioner of Food and Drugs