Guide for Command and Procurement Activities
The purpose of this document is not to be the sole source of information, but a tool to help explain the procedures and responsibilities of the command activities and activities procuring laser products that have not already been approved for use in the Navy & Marine Corps.
On 29 July 1976, the Food and Drug Administration (FDA) granted exemption #75EL-01DOD from federal guidelines for laser system safety design to the Department of Defense (DoD) using lasers and laser systems that meet any of the following criteria:
- System is Classified in the interest of National Security
- System used only in Combat
- System used only for Combat Training
A laser system that meets any one of these criteria should be made "Military Exempt." DoD has agreed to maintain a permanent record of the status of all of these laser products, including their ultimate disposition. Also, by the terms of this agreement with the FDA, no exempt laser products may be disposed of through excess or surplus property channels without advance authorization by the Assistant Secretary of Defense (Force Management and Personnel) or his designee.
In a letter dated 18 Mar 1986, the FDA amended the military exemption to remove the requirement that the DoD submit an annual laser inventory report to them. However, the FDA continues to require that the government maintain an inventory of all military exempt, Class 3B, and Class 4 lasers and laser systems. An inventory of these lasers and laser systems must be maintained by the activity with cognizant control of the lasers and shall be submitted to the Administrative Lead Agent upon request.
SECNAVINST 5100.14 requires that all commands, contracting and supply activities, research and development activities and acquisition program managers:
1. Identify laser products that are covered by the exemption and establish procedures to ensure that exemptions are granted only to laser products designed expressly for actual combat or combat training operations or classified in the interest of national security.
2. Provide written notification from the contracting officer to the manufacturer of each laser product that is covered by the exemption, with copy to the ALA. Sample notification format and caution label statement is shown in enclosure (3) of DODINST 6055.15. The manufacturer must attach a caution label, as specified in the sample, any deviation from the specified caution label and the reason for the deviation shall be reported directly to the ALA in keeping with the format in enclosure (1) of SECNAVINST 5100.14.
3. Include system safety provisions in all military exempt laser procurement documentation. As a minimum, the following shall be specified:
a) A system safety program per MIL-STD-882 and DOD 5000.2-R. The program shall include a system safety program plan, in depth hazard analysis and risk assessment of the equipment during various phases of its life cycle, hazard analyses of training and testing sites, routine surveys of equipment located aboard ship, on aircraft and ashore, and operator training in the safe use of the laser system.
b) Safety controls and procedures of ANSI Z136.1 and analysis and reporting of those portions of 21 CFR 1040 that cannot be met. Hazard controls at least equal to those of 21 CFR 1040 shall be provided. Justification for noncompliance with 21 CFR 1040 shall be documented. Highlight those significant hazards that cannot be corrected or for which a solution has not been identified and implemented.
4. Establish a safety review procedure to determine whether adequate hazard analyses and corrective actions have been completed and that exempt laser systems under their cognizance have been designed and will be operated under the applicable requirements of OPNAV 5100.27/MCO 5104.1, ANSI Z136.1, and OPNAV 5100.23E. Additional guidance may be obtained from the ALA with respect to laser hazard prevention or medical surveillance.
5. During each phase of development, prior to AFP/ALP, and for major modifications, submit documentation concerning each military exempt laser product to the LSRB for safety review and approval per OPNAV 5100.27/MCO 5104.1.
6. Plan, budget and provide funding to the LNTL to perform an independent safety analysis of the laser system prior to LSRB review, as appropriate. Planning for development or acquisition of military exempt lasers should also include sufficient schedule time for completion of the independent safety analysis.
SECNAVINST 5100.14 requires that all commands shall:
1. Prohibit the use of all military exempt lasers that have not been reviewed and approved safe for use by the LSRB.
2. Ensure that all laser operating procedures are in accordance with OPNAV 5100.27/MCO 5104.1, ANSI Z136.1, and OPNAV 5100.23. Substantive amendments to these procedures shall be provided to the ALA for review.
3. Maintain inventory control and permanent record of the status of all exempted laser products, including their ultimate disposition.
4. Report excess lasers to the Defense Reutilization and Marketing Service for utilization screening within DOD and maintain accountability during the reporting period. Transfer of excess lasers shall be made directly between the gaining and losing organization but only after notification and approval by the ALA. See enclosure (3) of SECNAVINST 5100.14 for recommended format.
5. Develop, in conjunction with Systems Commands, an appropriate demilitarization disposal plan for all military exempt lasers.
6. Dispose of exempted lasers per DOD 5000.2-R. No disposal of potentially usable lasers or laser parts for use outside of DOD, donation, or sale shall be made without prior approval of the ALA. See enclosure (2) of SECNAVINST 5100.14 for recommended format.
7. Submit a copy of their implementing instruction and the name of their designated Military Exempt Coordinator to the ALA if they are users, holders or inventory managers of military exempt lasers.
Laser Safety Review Board (LSRB)
SECNAVINST 5100.14 designates BUMED as the Administrative Lead Agent (ALA) for the Navy and Marine Corps. One of the responsibilities that have been given to the ALA is the responsibility of ensuring that the LSRB reviews all military exempt, Class 3B, and Class 4 laser products during each phase of development and prior to approval for production. OPNAV 5100.27/MCO 5104.1 gives specific details as to the steps required to submit laser systems for approval to the LSRB. Typically, to bring a new laser product into the Navy & Marine Corps system, the command activity, contracting/supply activity, or R&D activity:
- Decides to acquire a laser
- Develops laser and system safety program
- Issues a military exemption to the manufacturer of the laser after identifying the laser as fitting into one of the three military exempt scenarios described above
- Notifies the ALA and Chairman of the LSRB of the laser or changes to an existing laser
- Schedules and funds the LNTL to perform an independent laser hazard evaluation
- Schedules an LSRB meeting with the chairman of the LSRB
- Submits LSRB data package (see enclosure 4 of OPNAV 5100.27/MCO 5104.1) to the LSRB members 30 days prior to scheduled LSRB meeting
- Attends and presents system description, background, use, etc. of laser system at LSRB meeting (Laser safety analysis is presented by the LNTL)
- Acts on any action items given to them from the LSRB
- Repeats steps 4-9 as necessary throughout the laser life cycle
For questions needing immediate attention or to schedule a laser hazard analysis please the LNTL.