The federal drug-testing program had its beginnings one cloudy January afternoon when two men shared a joint. At the time, they were operating three 130-ton locomotives.
When the drug tests proved positive, federal officials started a program to regularly test railroad workers. Less than four years later, in 1991, Congress decreed that in addition to railroad crews, airline workers who flew, people with commercial driver’s licenses, transit employees and the U.S. Coast Guard also should be tested for five critical drugs.
Twenty-five years later, the test remains the same, but illegal drug use has changed significantly. The 21st century has become the era of addiction to prescription painkillers — drugs with familiar brand names such as OxyContin, Percocet, Vicodin, Fentanyl and Valium.
The federal program doesn’t test for any of them, or for any of the other popular synthetic opioids. This is not a case, however, of federal officials missing the boat in updating their drug testing. Instead, it is a case study in the long and tedious process required to change a federal rule.
At the turn of the century, deaths from illegal use of prescription drugs mirrored the number from cocaine, about 4,000. By 2013 they had nearly quadrupled, and the Centers for Disease Control and Prevention was calling the abuse of prescription drugs an epidemic.
"From 2013 to 2014, the largest increase in the rate of drug overdose deaths involved synthetic opioids," the CDC said in a report. A record 28,647 people died from heroin and prescription opioid use in 2014.
“It was really around 2008, 2009 when we started to see a problem,” said Ron Flegel, who heads the Division of Workplace Testing at the Substance Abuse and Mental Health Services Administration (SAMHSA).
If all goes according to schedule, the rule to allow testing of transportation workers for illegal prescription drugs will emerge in 2017.
Changing rules, or creating new rules, in the federal government is a bit like herding cats and generates mountains of paperwork. The rule change being shepherded by SAMHSA will have gone through 14 steps, multiple agency reviews and a period for public comment before taking effect.
Five years of work has been devoted to making two basic changes: One would allow testing for illegal prescription drugs, and the other would allow test labs to use saliva, in addition to urine, for testing.
Federal lore abounds with examples of the ponderous and protracted rule-making process.
A classic illustration is the rule to install back-up cameras in cars. In 2008, President George W. Bush signed a law that specified that the cameras be installed in new cars by 2011.
But first, it fell to the National Highway Traffic Safety Administration (NHTSA) to draft a formal rule to enforce the law. NHTSA proposed a rule to phase in camera use in 2012, with the goal that all new cars would have them by 2014. The proposal was sent to the White House Office of Management and Budget (OMB), which recommended that NHTSA consider cheaper alternatives.
After bouncing around among federal agencies and the OMB, the rule was finalized in 2014, the same year that a NHTSA study said an average of 232 people a year, including 95 children, were killed in back-overs that the cameras might have prevented.
By next year, six years after Bush signed the law, 40 percent of new cars will be required to have back-up cameras. All new cars must have them by 2018, seven years later than Congress had intended.
NHTSA found an artful way around the rule-making process when it came to driverless cars. Aware that the speed at which the technology was being developed probably would render any rule outdated by the time it was finalized, NHTSA plans to announce “guidance” for automakers and state officials. It won’t be enforceable, but neither did it take so long to reach fruition, and it will allow the agency flexibility in dealing with emerging technology.
There was no workaround for SAMHSA when the need arose to test for illegal prescription drugs.
“You have to make it scientifically supportable and forensically sound,” Flegel said. “It is a lengthy process, but a very necessary process to go through because you’re proposing a rule.”
Since 1991, transportation workers have been tested for marijuana, cocaine, amphetamines, natural opiates and PCP.
Although awareness of the prescription-drug problem began a few years earlier, changing the official rule to allow testing for it began in 2012, when the SAMHSA administrator received a recommendation from her Drug Testing Advisory Board.
As Flegel recounts the timeline, the recommendation was passed on to the secretary for Health and Human Services, and the Behavioral Health Coordinating Committee for a two-month review. The surgeon general also was asked to have a look.
Then a proposed rule was drawn up by the Division of Workplace Programs and sent to the SAMHSA administrator for review.
“That was about a year later, in 2013,” Flegel said.
After incorporating revisions received so far, the proposal was sent to the OMB, which looked it over and then distributed it to federal agencies to gather their comments.
“There’s multiple agencies that have rule-making that look at it specifically,” Flegel said.
Based on agency comments, SAMHSA revised the proposed rule once more.
“Then that process starts over,” Flegel said. “It goes back to HHS, back to OMB and, once approved by OMB, goes out for public comment.”
The window for public comment is open for three months.
“We pull those comments from the public and then revise the proposed mandatory guidelines accordingly,” Flegel said.
Right now, those revisions are under another round of reviews.
“We are now still in the process where it has been revised, it has gone through an HHS clearance and it has now been logged in so the public can see the website,” Flegel said. “The next steps to the process would be, once approved by OMB, it will go out as a federal register notice, and that federal register notice will be the final guidelines and it will have an implementation date.”
Asked when he expects the testing to begin, Flegel said, “I can’t really give an estimated date. But what we had sort of looked at was try to implement around the first of the year, so we can assume it will be 2017.”
What those tests may reveal was foreshadowed by post-accident testing of railroad workers this year. After a crash, the Federal Railroad Administration (FRA) conducts more exhaustive testing than for just the five drugs covered by the 1991 rule.
“We know that the country is struggling with an opioid epidemic — and there is no reason why our industry would be immune from an epidemic affecting the entire country,” FRA Administrator Sarah E. Feinberg said last week in remarks to the Railroad Safety Advisory Committee.
In at least one of six post-accident tests that were positive for drug use, the worker was on OxyContin, internal federal records indicate.
After the fatal 1987 collision between the Conrail locomotives and the Amtrak train, the National Transportation Safety Board determined that a shared marijuana joint was the “probable cause.”
The Conrail brakeman, Butch Cromwell, agreed to testify against the engineer, Ricky Lynn Gates, in return for immunity from prosecution. Gates was charged with manslaughter by locomotive and served four years in prison.
