New regulations on biological materials get mixed reviews

New federal regulations announced Tuesday to tighten controls on biological agents and toxins have received mixed reviews from microbiologists.

Experts said the regulations, intended to keep dangerous biological materials out of terrorists' hands and mandated by a law passed this year, go too far in some areas and not far enough elsewhere. The regulations affect the possession and transfer of "select agents" and toxins such as the anthrax bacteria and the smallpox and Ebola viruses, as well as lesser-known pathogens.

The new regulations, consisting of two sets of rules issued in tandem by Health and Human Services and Agriculture departments, are to take effect Feb. 7, pending public comments.

Richard Ebright, laboratory director at Rutgers University's Waksman Institute of Microbiology, faults the regulations, for instance, for not requiring specific access-control and monitoring measures at facilities.

Ronald Atlas, president of the American Society for Microbiology, however, believes the new security requirements could dampen enthusiasm for work with select agents.

"If I had select agents in my lab, I think I'd have to give serious consideration in the morning as to whether I really want to do this or not," he said in an interview yesterday.

"Which is not to say they [the new regulations] are wrong. They might represent the right, essential steps," Atlas added. "But, they represent a significant culture change to at least how some of us in academia run laboratories," he said.

Some of the paperwork requirements are "nothing short of draconian," said Steven Block, a Stanford University biophysicist. According to one key requirement, nongovernmental facilities are required to obtain a risk assessment from the Justice Department before they can receive, possess, use, or transfer any select agent.

"All these regulations in the end will be an enormous burden for those people trying to implement them," said Block, who argued such restrictions on select agents ultimately "won't stop the bad guys."

With the exception of the smallpox virus, most agents and toxins are widely available around the world, as is the information to weaponize them, he said.

Promoting the new rules in an announcement this week, HHS Secretary Tommy Thompson said, "Protecting the health of Americans is paramount, and this new rule strengthens our ability to ensure that essential research on these agents continues while making certain they don't fall into the wrong hands."

The regulations require laboratories handling select agents to be registered with the Centers for Disease Control and Prevention or the Agriculture Department, depending on the agent.

Previously, facilities had only to report transfers of such materials to federal authorities. So far, 817 of an estimated 1,167 academic, commercial and government facilities have registered, according to the CDC.

The regulations also restrict access to such agents by certain groups of people. To accomplish that requirement, laboratories must first submit names of people chosen to handle select agents to the Justice Department for screening using numerous databases.

The CDC anticipates an estimated 20,000 staff will be subjected to such "risk assessment" screening.

As required by the law, select agents, toxins or delivery systems can be possessed only if possession can be "reasonably justified" for specific "bona fide" research or other peaceful purposes, which has raised concerns biologists can no longer preserve specimens unspecific future use.

Security Risk Assessment

The classes of restricted people include aliens from a country on the State Department's list of terrorism sponsors, admitted or convicted users of a controlled substance, persons indicted or convicted of a crime punishable by imprisonment for more than one year, dishonorably discharged veterans, fugitives from justice, illegal aliens, and persons adjudicated as mentally defective or committed to a mental institution.

HHS also may bar people suspected of involvement or association with organizations suspected of involvement in terrorism.

Violations can be punished with up to a $10,000 fine, 10 years imprisonment or both. The regulations were published independently by the Health and Human Services and Agriculture departments, to implement requirements of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 signed into law last June and the USA Patriot Act signed October 2001 in the wake of the Sept. 11 attacks and anthrax mail attacks.

"The [bioterrorism preparedness] act bolstered the authority to protect against misuse of select agents and toxins whether inadvertent or the result of terrorist acts against the United States homeland (such as the recent terrorist acts involving anthrax) or other criminal acts," HHS said in a statement on the regulations.

Areas for Tightening Suggested

Ebright said the regulations represent an "important first step" in securing research laboratories with pathogens relevant to bioterrorism.

In a letter sent to the CDC yesterday, however, he called for strengthening the new rules in a number of areas. He said the regulations should be more specific in describing how to control access to biological facilities and how to monitor security. The new regulations leave those decisions to individual facilities, but Ebright said video surveillance and, in some cases, security personnel should be required.

Atlas said there was some merit to that idea, that the lack of specified measures "creates a certain angst for me and the community to know, 'how do we know we did the right thing?'"

Ebright also recommended restricting additional types of research, such as efforts to make select agents resistant to vaccines, to make them more environmentally stable or to powderize or aerosolize them.

Atlas said such restrictions would need to be carefully scrutinized to prevent unnecessary limits on research into new vaccine delivery methods, or even something as common as deodorants.

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