GUIDELINES AIM TO TIGHTEN LAB SECURITY



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Last Updated

06 Dec 2002

Source: Associated Press, December 6, 2002.

Guidelines Aim to Tighten Lab Security

By LAURA MECKLER, Associated Press Writer

WASHINGTON -- Scientific labs now have detailed guidelines about how to protect dangerous pathogens as federal officials work to pump up regulation in a notoriously weak field.

Recommendations issued Thursday are the most detailed ever produced by the Centers for Disease Control and Prevention. Among them: Monitor areas where pathogens are stored, keep specimens locked up and confine access to those authorized to work with these agents.

Congress mandated the new rules following last year's spate of anthrax attacks. The case remains unsolved, but experts suspect the anthrax sent through the mail came from a U.S. laboratory.

Next week, the CDC will publish regulations requiring tighter security at labs that handle "select agents," 42 pathogens and toxins that pose the greatest dangers to the public's health. The list includes bacteria that cause anthrax, plague and viruses such as ebola, as well as lesser known agents.

The new rules will require every lab that possesses a select agent to register with the CDC or the Agriculture Department and undergo an inspection. Previous law only required labs that transferred or received specimens to register, leaving a giant loophole that meant federal officials investigating last year's anthrax attacks initially had no idea how many labs possessed anthrax.

The rules will also require background checks for people who work with select agents and require all labs to develop a biosecurity plan. The guidelines issued Thursday are aimed at helping labs develop these plans. Past guidance was a "fairly skimpy" two pages, said Steve Ostroff, deputy director of the CDC's National Center for Infectious Diseases.

In the past, lab security was typically focused on biosafety, or protecting the people who work in labs. Now, the focus is shifting to biosecurity.

Typical security controls -- such as keeping track of inventory -- don't work for biological agents, which can easily grow and multiply in the right lab conditions. So the guidelines offer other suggestions, including better control over access to the pathogens and security of the facility.

It is unclear how many labs possess select agents, and CDC won't say how many are already registered because they received or transferred an agent. The last time the number was made public, about two years ago, about 250 labs had registered, but that number has grown by about 5 to 10 labs per month since then, Ostroff said. That means there could be some 350 to 500 already on the list.

The final number, after all labs that possess agents register, is expected to be "substantially higher," Ostroff said.

The tighter standards and the increased number of labs that are subject to them will present a significant challenge to the CDC, which according to congressional auditors has done a poor job of enforcing its earlier mandate. Last month, the General Accounting Office said the CDC's enforcement of the select agent rules was fraught with problems, posing an "urgent and potentially serious public health threat."

The CDC says it has hired more staff and contractors to clear a backlog of labs awaiting inspection and otherwise improve the program.

After the formal regulation is published next week, the CDC will take public comments for 60 days before issuing final rules. A public forum is planned for December in Washington to get feedback from interested parties.