For the record: A toxic proposal

After the NTSB examined the prevalence of drugs found by toxicology testing of fatally injured pilots between 1990 and 2012, it issued several recommendations to the FAA, including recommendation A-14-95. It suggests the FAA “conduct a study to assess the prevalence of over-the-counter, prescription, and illicit drug use among flying pilots not involved in accidents, and compare those results with findings from pilots who have died from aviation accidents to assess the safety risks of using those drugs while flying.”

In response, the FAA’s Civil Aerospace Medical Institute (CAMI) devised a study to randomly collect and test urine specimens that pilots provide to aviation medical examiners (AMEs) during medical exams. Normally, a pilot’s urine specimen is collected by an AME during a medical exam, tested for indicators of kidney function and diabetes, and then discarded. The NTSB’s recommendation did not require or request testing of pilots’ urine.

The proposal calls for the FAA to choose five to six AMEs in each FAA region, whose practices are representative of the pilot population, to participate. The AMEs would fill out a label for each specimen selected, indicating class of medical applied for, pilot’s age range, and highest certificate obtained. Specimens would be refrigerated until being sent by overnight delivery to the FAA.

The FAA’s Toxicology Research Team would carry out a full toxicology drug screen using procedures for aviation accident investigations, including about 180 drugs of interest to the FAA. According to the FAA, no other testing would be allowed; specimens would be secured in a freezer, and destroyed within one year of analysis.

Neither AMEs nor the FAA would be required to obtain the pilot’s explicit consent for their urine specimen to be selected for the study or inform the pilot that his or her specimen was chosen. An FAA institutional review board decided the study met exemption criteria under federal rules that otherwise require informed consent. By reusing urine specimens already being collected for medical certification purposes, it is the FAA’s position that the study is “secondary research.” Federal rules do not require consent for secondary research if information is recorded in such a manner that the identity of the subjects cannot readily be ascertained and the investigator does not contact or re-identify the subjects.

Only recently has the FAA proposed adding a statement to the online MedXPress medical application that “provides information about the study, emphasizes the anonymity of the samples, and states that the results will not be used in any disciplinary or legal action against any airman.” However, if a pilot is linked to a result, no federal aviation regulation specifically prohibits the use of the study information for enforcement or certification purposes. The FAA has implemented such rules for other programs, such as FAR 91.25’s prohibition against use of NASA Aviation Safety Reporting System reports for enforcement purposes. Furthermore, should a pilot decide not to participate, the only option is to not apply for a medical. According to the FAA, allowing pilots to opt out of the study “would invalidate the study due to differential selection impacting all study variables.”

Should the study proceed, the FAA suggests its results would be used to “establish regulations regarding the approval of drugs for use by pilots and to warn pilots of the risks associated with these medications.” A pilot’s use of drugs is addressed by existing rules such as FAR 91.19, which prohibits acting or attempting to act as a crewmember while using any drug that affects the pilot’s faculties in any way contrary to safety. Likewise, FAR 61.53 prohibits pilots from flying if they are taking medication for a medical condition that results in the pilot being unable to meet the requirements of their medical certificate.

AOPA is strongly fighting the study. In a joint letter to the FAA, AOPA and other pilot groups urged abandonment of the study entirely, asserting they “believe the study does not comply with legal requirements, represents a waste of government funds and resources, and will further erode any trust left between the pilot community and the Office of Aerospace Medicine.” The groups also detailed their “strong belief that outreach, communication, and education are areas where the FAA should focus its resources” and expressed their willingness to partner with both the FAA and NTSB on those efforts.

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