BIOTERRORISM LEGISLATION PUTS NEW SCRUTINY ON RESEARCHERS 



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Last Updated

13 Dec 2002

Source: Chronicle of Higher Education, May 24, 2002.

Bioterrorism Legislation Puts New Scrutiny on Researchers, Allows Current Projects to Continue

By RON SOUTHWICK

Congress approved bioterrorism legislation this week that would give universities more responsibility for guarding biological agents they use in research, but would not greatly disrupt such studies, college lobbyists say.

The legislation, HR 3448, would provide $4.6-billion to state programs and improve federal laboratories. It represents a compromise of competing bills that had previously passed the House of Representatives and the Senate. The Senate approved the compromise measure on Thursday, a day after the House overwhelmingly passed it by a vote of 425 to 1. President Bush is expected to sign the bill.

Under the legislation, every university and laboratory that works with "select agents" -- defined as biological material that could be used to pose a public health threat -- would have to be registered with the U.S. Department of Health and Human Services or the U.S. Department of Agriculture. Current law requires only laboratories that ship such materials to be listed with the government. Lawmakers have complained that they do not have a clear idea of how many people are working with potentially dangerous biological materials.

The legislation would impose new steps designed to limit access to 42 biological agents, including anthrax, the Ebola virus, and smallpox. The bill would bar from working with those materials any scientists from countries that are listed as sponsoring terrorism, including Iraq and Iran, and any researchers with criminal records. However, all scientists handling such agents -- including U.S. citizens -- would have to be screened by the government.

College lobbyists say it is unlikely that a university researcher currently working with biological materials or toxins would be restricted from such work in the future. Lobbyists said they were especially pleased that the legislation spells out that scientists who are in the midst of a research project will be allowed to continue their work while the government performs its background checks.

"We were very concerned that there would be a period of time when research would come to a halt," said Janet Shoemaker, director of public affairs for the American Society for Microbiology.

Under the terms of the bill, colleges would have to submit the names of researchers studying biological agents to the Department of Health and Human Services. Universities would also have to get clearance for scientists doing research on plant and animal pathogens for the U.S. Department of Agriculture. The U.S. attorney general's office would conduct the background checks, a step sought by college lobbyists, who had feared that research institutions would have to perform screening themselves.

If a university wished to hire a new scientist to work on select agents, that person would not be allowed to begin work on those materials until the screening is complete. The legislation also includes provisions for an appeals process if the government denies approval.

While college lobbyists are glad that universities themselves will not be responsible for screening employees, some wonder how long the government reviews will take, Ms. Shoemaker said.

In the event of an emergency, the measure would allow scientists to work on biological agents without being screened. Researchers had feared that in a crisis involving bioterrorism, scientists would lose valuable time waiting to gain clearance.

The Health and Human Services Department and the Agriculture Department would each have to draw up regulations regarding the study of biological agents. College lobbyists said they would work with the agencies to see that those rules do not go beyond the protections spelled out in the bioterrorism legislation.

The Centers for Disease Control and Prevention would get $300-million to modernize its laboratories under the legislation. Lawmakers in Congress, chiefly Sen. Arlen Specter, a Pennsylvania Republican, have said that the center's facilities are in dire need of upgrades.