DOT AND FAA PROPOSE NEW RULES FOR ON-BOARD ACCEPTANCE OF PORTABLE OXYGEN CONCENTRATORS
October 8, 2014
On September 19, 2014 DOT published a NPRM concerning revised criteria for evaluating Portable Oxygen Concentrators (POCs) for use on board aircraft. The proposed rule would affect the use of POCs on board aircraft in operations conducted under 14 C.F.R. parts 121, 125, and 135, and also have tangential impacts on foreign carriers by virtue of compliance with the requirements of Part 382.
In 2005, the FAA established standards for the use of POCs on board aircraft through Special Federal Aviation Regulation (SFAR) No. 106—Rules for use of portable oxygen concentrator systems on board aircraft. The FAA has historically limited the carriage and use of POCs on board aircraft to only those models that have been pre-approved by the Administration. Each time a new POC is approved by the FAA, SFAR No. 106 must be amended to include the name of the newly approved POC. This is a long and arduous process that can in some cases take more than two years.
Rather than amend existing SFAR No. 106 every time, the proposed rule seeks to replace the existing FAA case-by-case POC approval process in SFAR No. 106 with an “acceptance criteria” methodology for POCs.
Under the proposed rule, manufacturers of POC models not identified in SFAR No. 106 would have to ensure their POC satisfies the FAA’s acceptance criteria before it may be used on board an aircraft. If a manufacturer determines that a new POC model meets these criteria, it would not need to seek FAA approval. Rather, it would need only to affix a label to the POC, indicating that it meets FAA acceptance criteria. The FAA believes this proposed label would facilitate passenger and crew recognition by identifying the POC as safe for use in the cabin during all phases of flight.
The proposed acceptance criteria are:
- The POC manufacturer complies with all FDA requirements to legally market the device in the United States; and
- The POC may not contain any hazardous materials subject to the Hazardous Materials regulations (49 CFR parts 171 through 180) except as provided for in the exceptions for crewmembers and passengers (49 CFR 175.10); and
- The maximum oxygen pressure generated by the POC must fall below the threshold for the definition of a compressed gas per the HMR; and
- The POC electromagnetic emissions must fall below the threshold permitted in RTCA standard 160G, Section 21, Category M.
Devices previously approved for use on board aircraft would be grandfathered in.
Comments on the NPRM must be submitted before November 18, 2014. The FAA is considering an effective date of 90 days after the final rule’s publication in the Federal Register.
If you have any questions, please contact Evelyn Sahr (esahr@eckertseamans.com, 202-659-6622) or Drew Derco (dderco@eckertseamans.com, 202-659-6665).