Smallpox Law Needs Fix

Two years after Congress banned the synthesis of the smallpox virus, a federally appointed panel has recommended that the law be dropped from the books. The National Science Advisory Board for Biosecurity (NSABB), which is helping the U.S. government develop safeguards against the wrongful application of life sciences research, decided at a meeting today that the law--known as the variola amendment-–is too vague to be helpful in the fight against bioterrorism and is instead hurting research.

The amendment, which was enacted on 17 December 2004, imposes a penalty of up to 25 years in prison for attempts to engineer or synthesize the smallpox virus (Science, 11 March 2005, p. 1540). It defines the pathogen as "a virus that can cause human smallpox or any derivative of the variola major virus that contains more than 85% of the gene sequence." Researchers have complained about that definition, which they say covers several pox viruses including a strain used for making vaccines.

Stanford biologist David Relman, who heads NSABB's working group on synthetic genomics, told the board that "the language of the [amendment] allows for multiple interpretations of what is actually covered" and that the 85% sequence stipulation is "arbitrary." Therefore, he said, "we recommend repealing" the amendment.

Relman's group also recommended that the government revamp its select agents list in light of advances in synthetic genomics. These advances make it possible to engineer biological agents that are functionally lethal but genomically different from pathogens on the list. The group's recommendations, which were approved unanimously by the board, are among several that the board will pass on to the U.S. government to help develop policies for the conduct and oversight of biological research that could potentially be misused by terrorists.

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