Safety, Security Demanded for Bioagent Transfers

By Chris Schneidmiller
Global Security Newswire

WASHINGTON — Infectious agents are regularly shipped around the United States in automobiles and airplanes, but that doesn’t make the courier truck parked at the curb a cause for alarm, according to U.S. officials and commercial carrier representatives.

Strict federal rules are meant to prevent mishaps involving samples of “select agents,” whether they are being studied at a laboratory or transferred between research facilities.

Apart from the occasional accident — notably a courier truck that crashed in March in Canada while carrying samples of anthrax and several other pathogens (see GSN, March 3) — shipments of biological material rarely come to the public’s attention. 

Those involved in these exchanges promote this low profile by saying little publicly about the toxins they are storing and moving.

“I can’t get into any detail for what we do move and who we move it for,” said FedEx spokesman Jim McCluskey.

“Those are all things that the organization considers confidential and won’t disclose,” said an official at American Type Culture Collection in Manassas, Va., which distributes biological material to research organizations around the world.

“It’s kind of a sticky question,” said Caree Vander Linden, spokeswoman for the U.S. Army Medical Research Institute of Infectious Diseases at Fort Detrick, Md.

Sharing materials is “invaluable” as facilities study pathogenic agents and prepare defenses against a possible biological attack, said Von Roebuck, spokesman for the Centers for Disease Control and Prevention. Laboratories that may be conducting complementary research benefit from being able to exchange specimens, he said. That, in turn, could lead to a new vaccine.

“There are a lot of scientists out there who need to have the base materials to do their work,” said Gigi Kwik Gronvall, an associate at the University of Pittsburgh Center for Biosecurity.

In the 1950s, researchers could simply pack up a sample and drive it to its destination, said James Tracy, associate dean of research at the University of Wisconsin School of Veterinary Medicine. Such easy transfers are forbidden by present federal regulations on infectious materials, which were updated following the Sept. 11 attacks and subsequent anthrax mailings.

Select agents and toxins are infectious pathogens designated by federal agencies as having the potential to cause serious harm to humans, animals and plants. Anthrax is a select agent, while the common cold virus is not.

Facilities that work with agents that could harm humans must register with the Centers for Disease Control and Prevention. There are 333 entities registered with the federal health agency; most are research laboratories, Roebuck said.

The U.S. Agriculture Department’s Animal and Plant Health Inspection Service is the oversight body for laboratories researching agents that pose a risk to plant or animal life. Seventy-two entities have registered with the agency, said spokeswoman Melissa O’Dell.

Both agencies have extensive rules for the control, use and transfer of select agents, which range from ricin to Rinderpest. Breaking the rules can lead to a $500,000 fine for the violating entity, and a $250,000 penalty and up to five years in prison for an individual.

The U.S. Justice Department conducts background investigations of any organization that registers to work with select agents, along with its owners and the employees who work with the materials.

Entities must notify and receive approval from their oversight agency before shipping select agents. Roebuck said his agency receives roughly 40 requests each month, primarily from federal agencies. Even CDC researchers must receive permission to send toxin samples to their counterparts at Fort Detrick.

The Agriculture Department has received 60 transfer requests to date in 2005, O’Dell said, listing academic, commercial and government entities among the senders and recipients.

U.S. regulations require that materials be enclosed within two watertight containers and then an outer shipping vessel. No more than four liters of agent can be contained in a single outer shipping container. Packaging must be able to withstand leaks, shocks, changes and pressure and other pitfalls of the shipping process, according to rules on interstate transfers.

Shipments can only be made to other entities that are registered with the Centers for Disease Control and Prevention or Agriculture Department.

The U.S. Transportation Department requires that transporters of select agents develop security plans and train their drivers. “At a minimum, a security plan must address personnel security, unauthorized access and en route security,” according to the agency. Employees must be able to recognize and respond to a threat.

The details of the plans are left to the transporters, said Joe Delcambre, spokesman for the DOT Pipeline and Hazardous Materials Safety Administration.

“We left some flexibility in the requirements so that each individual company … can mold it to their size and type of operation that they have,” Delcambre said.

There are more than 40,000 hazardous materials shippers registered with the Transportation Department. Delcambre could not say how many carry infectious agents.

Generally, only the major firms handle this kind of work, according to the University of Wisconsin’s Tracy. That means the U.S. Postal Service and shippers such as FedEx and United Parcel Service.

Spokesmen for all three entities said their employers’ have significant policies to ensure the safety and security of any dangerous goods they carry. They declined to discuss details of those policies.

Also left deliberately unsaid by the companies and their research clients are specifically what sort of agents they handle and in what amounts. “Obviously you’re not going to have a van full of anthrax that’s going to go down the road,” Roebuck said.

Shippers reported 292 incidents that occurred during transfers of infectious substances last year to the Transportation Department. An incident is generally “an unintentional spill of hazardous material,” Delcambre said, noting that does not mean the substance escaped all three container layers. More than 200 of the spills were of “diagnostic specimens” — blood, tissue and other human or animal material — followed in number by medical waste. 

The Transportation Department released to Global Security Newswire electronic copies of reports on incidents from 2000 to 2004 involving materials designated “Infectious Substance,” “Infectious Substance Human” and “Infectious Substance Animal.” Only three of the documents identified the substance involved — salmonella, Hepatitis B and blood. No one was killed or injured in the incidents, the reports state.

An accident might ruin the sample if it cannot be kept cool, but it is unlikely to endanger the public, Gronvall said.

The likelihood of a theft during transit is also small, according to Roebuck.

“I’ve never heard of any situation where someone stopped one of these vehicles and said, ‘I want the specimen,’” he said. “I think the risk level there is quite limited. We’ve had a lot of transfers over the years.”

The federal health agency itself is “shipping all the time,” Tracy said.  Roebuck said security issues prevented him from discussing the frequency of sample transfers. Representatives from several U.S. university research sites declined to comment or did not respond to requests for information on their programs.

Gronvall said the high fees charged for shipping select agents and the time needed for laboratory personnel to obtain their security clearance are barriers to studying potential bioterror agents and natural infections such as avian flu and SARS.   A U.S. Justice Department report issued in March found that security-clearance applications for researchers seeking to work with biological agents were being processed within 45 days. “From the scientific perspective, that’s ages,” Gronvall said.

The University of Wisconsin has probably conducted less than five such shipments since 2003, Tracy said. It prefers to work with the specimens already in its possession rather than taking on the rigorous exchange process, he said.

“To be honest, it’s such a pain you don’t do it unless you have to,” Tracy said.

Back to top
About Newswire  |  Contact National Journal  |  Re-Use Guidelines © Copyright 2008 by National Journal Group, Inc. The material in this section is produced independently for NTI by National Journal Group, Inc. Any reproduction or retransmission, in whole or in part, is a violation of federal law and is strictly prohibited without the consent of the National Journal Group, Inc. All rights reserved.