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Food and Drug Administration campus in Silver Spring, Md. / Alison Young, USA TODAY

Corrections & Clarifications: An earlier version of this story misstated the status of testing on some of the new vials of biological materials found at the National Institutes of Health.

Just hours after members of Congress grilled the director of the Centers for Disease Control and Prevention about his agency's mistakes with anthrax and bird flu, another federal health agency provided an update on its mistakes with vials of deadly smallpox virus.

The U.S. Food and Drug Administration revealed that more than 300 other sealed vials containing biological materials such as dengue, influzena, Q fever, ricksettsia and other possible unknown viruses were found alongside the six forgotten smallpox vials in the storage room on the National Institutes of Health campus.

The FDA commissioner has asked for a sweep of all cold storage facilities under FDA jurisdiction, said Karen Midthun, director of FDA Center for Biologics Evaluation and Research.

"The fact that these materials were not discovered until now is unacceptable," Midthun said. "We take this matter very seriously and we're working to make sure it won't happen again."

FDA officials note that the other pathogens listed on the additional vials do not pose the same level of danger as smallpox.

The discovered materials included 10 vials with unclear labeling. Those along with the six vials labeled as containing smallpox virus were transported to a CDC high-containment facility in Atlanta. Two of the six smallpox vials have been found to have live smallpox virus, CDC Director Tom Frieden said last Friday. Midthun said testing continues on the remaining four.

"At this point, it's not possible to say how many agents were deadly or contained dangerous materials," said Peter Marks, deputy director of FDA Center for Biologics Evaluation and Research.

About 32 samples were destroyed after the vials were discovered, and more than 200 other samples were transferred to the U.S. Department of Homeland Security's National Bioforensic Analysis Center for safeguarding. No smallpox vials were included in the transfer, Midthun confirmed.

The 327 vials of biological materials, including the six smallpox vials, were found in 12 boxes in one corner of a cold storage area at the National Institutes of Health that had been operated since 1972 by the U.S. Food and Drug Administration. That's when the FDA took over regulation of vaccines, including the smallpox vaccine.

By international agreement, after smallpox was globally eradicated in the late 1970s, only two labs in the world were authorized to retain samples: the CDC in Atlanta and a lab in Novosibirsk, Russia.

The smallpox vials and other biological specimens appear to date from 1946 to 1964, and tests by the CDC have found some of the virus is still alive. The FDA and NIH are investigating how samples of such a deadly and restricted virus went unnoticed for decades.

The FDA discovered the vials while it was doing an inventory of its lab space at the NIH in Bethesda, Md., in preparation for moving the labs to an FDA complex in Silver Spring, Md. It remains unclear why the FDA had apparently not inventoried the cold storage area in decades.

FDA spokeswoman Erica Jefferson on Tuesday said the incident is still under investigation. She noted that laboratory practices and regulatory requirements have "undergone huge changes" since 1972.

"FDA has already completed an inventory of all common storage areas in its NIH campus buildings and found no other materials of public health concern," she said. "We are carefully examining our policies and procedures regarding the security of our laboratories and storage of biologic specimens."

The NIH, in a statement Tuesday to USA TODAY, said it is conducting a comprehensive search of all of its facilities to look for other select agents, toxins or hazardous biological materials improperly stored in any of its facilities. The plan requires investigators to examine all freezers, refrigerators, cold rooms, storage shelves and cabinets, as well as other storage areas and offices.

Frieden spent much of Wednesday morning testifying before an oversight subcommittee of the House Energy and Commerce Committee, which is investigating safety lapses at that agency that potentially exposed dozens of employees to live anthrax. None has been infected.



Copyright 2014USAToday

Read the original story: Chilling new details on cold-storage smallpox

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