Request letter to Mr. John Villforth, Director Bureau of Radiological Health from George Marienthal, Deputy Assistant Secretary of Defense (Environment and Safety)
ASSISTANT SECRETARY OF DEFENSE
2 Jul 1976
Mr. John Villforth
Bureau of Radiological Health
Rockville, Maryland 20852
Dear Mr. Villforth:
This is in response to 21 CFR Part 1010 rule changes that the Commissioner of the Food and Drug Administration proposed on September 4, 1974. The changes add a new section 1010.5 and provide for exemptions from standards for electronic products, primarily laser products.
Military laser products have special field-use considerations, such as weight, survivability, camouflage requirements, covert operations, which do not lend themselves to full compliance with all the standards promulgated under PL 90-602, Radiation Control for Health and Safety Act. In most instances, the specified defense mission requirements could not be satisfied if total compliance was accomplished.
I, therefore, propose that an exemption be granted for all military laser electronic products used exclusively by Department of Defense components and designed expressly for actual combat operations, combat training operations, and laser products classified in the interest of national defense. The exemption would not apply to laser products intended primarily for use in indoor classroom training and demonstration, industrial operations, scientific investigations, and medical laser products.
Because of the difficulties to achieve complete product safety with military hardware, the DoD components require proper laser user safety procedures in regulations and user guidance documents. Within the U.S. Army, they are: 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 Radiation, 30 May 1975. The user
guidance document for the U.S. Air Force is AF Manual 161-32, Laser Health Hazards Control, 20 April 1973. Those documents are enclosed. The ANSI 136. 1, 1973, American National Standard for Safe Use of Lasers, was adopted
by the U.S. Navy. Additional control procedures 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, as well as a hazard analysis of training and testing sites, and routine surveys of such equipment located at military installations.
The Department of Defense will establish monitoring procedures to assure that:
Only products which meet criteria in the third paragraph of this letter will be procured or manufactured by the DoD pursuant to the requested exemption.
The DoD will maintain a permanent record of the status of exempted laser products, including their ultimate disposition. The products will not be disposed through excess or surplus property channels without advance authorization by the FDA. All exempted products will be clearly identified, either by labeling as 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.
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 will be submitted to the FDA for review.
The Department of Defense will provide an annual report to FDA summarizing the internal records maintained on the exempted products, identifying types of laser products and manufacturers. Reporting and record keeping requirements prescribed in 21 CFR Part 1002, except for paragraph 1002.20, should be waived by the FDA.
I appreciate the time that you and your staff spent to assist the DOD to resolve a potential problem area. It is most gratifying to see this spirit of interagency cooperation.
Deputy Assistant Secretary of Defense
(Environment and Safety)