WASHINGTON -- Mandates included in new federal legislation could impair the ability of U.S. laboratories to conduct important biodefense research, according to a leading U.S. science organization (see GSN, Nov. 5).
(Nov. 19) -
A Centers for Disease Control and Prevention scientist looks out from inside an autoclave room within a high-containment laboratory. A top U.S. science organization has expressed concerns about the effects new legislation could have on disease research (Centers for Disease Control and Prevention photo).
The American Association for the Advancement of Science earlier this month submitted a letter to the bill's authors, Senate Homeland Security and Governmental Affairs Committee Chairman Joseph Lieberman (I-Conn.) and ranking member Susan Collins (R-Maine). It includes a series of comments and recommendations on the Weapons of Mass Destruction Prevention and Preparedness Act of 2009.
The association is primarily concerned that the bill calls for the establishment of a new system of oversight and security procedures under the Homeland Security Department for certain select agents, pathogens and biological toxins declared to pose a severe threat to human or animal health.
"We feel that having a whole separate system of oversight -- even if it is for 12 or 13 agents -- can very well complicate things about implementation," according to Kavita Berger, project director at the AAAS Center for Science, Technology and Security Policy. "And while you may have the best of intentions while writing the bill, it does not mean that upon implementation it will turn out the way that one intends."
Many in the biological research community have raised concerns that laboratories already must use time and resources that could be employed for research to deal with government security rules.
The Senate measure was approved Nov. 4 in an 8-1 vote of the homeland security panel. Senator Carl Levin (D-Mich.) was the sole vote of dissent. It could not be determined when a Senate floor vote on the bill is slated.
If approved, the legislation would require the Homeland Security Department to prepare security regulations for laboratories and divvies the government's list of select agents and toxins into three tiers. Facilities that handle the eight to 10 most dangerous materials would receive the highest security and be regulated by Homeland Security while the Health and Human Services Department would oversee sites in the remaining two tiers.
The bill could affect as many as 400 facilities and 15,000 individuals authorized to work with deadly pathogens, according to Collins.
The measure would also mandate the establishment of a national strategy for dispensing medical countermeasures to the public before and after a disease outbreak or act of bioterrorism.
Representatives from the scientific association met with staff members from the homeland security panel before the bill was introduced in September, Berger said Tuesday in a telephone interview.
After the committee's first attempted vote on the legislation Oct. 28 "we thought it was appropriate to make these comments a little more official," Berger told Global Security Newswire. She added that while the association offered its input to lawmakers, the group has no formal position on the measure.
A spokeswoman for the homeland security committee did not return repeated phone calls or an e-mail message request for comment.
The four-page letter begins by applauding lawmakers for consulting with academic and scientific experts to guide the development of new security standards and regulatory oversight of select agent research programs. It also compliments them for calling for common standards on which all institutions working with "tier one" pathogens can base their security measures.
However, the association believes oversight for the select agent program should remain within the Centers for Disease Control and Prevention and the Agriculture Department's Animal and Plant Health Inspection Service.
Berger said that rather than having Homeland Security establish and oversee laboratory security standards the department could simply provide input to CDC officials.
"Trying to keep it simple, trying to affect change within the existing system to improve some of the problems that currently exist, would be good," Berger said. "A lot of the problems are not with the select agent program per se but rather more with the other agencies wanting to have their own oversight over the research that they fund."
Laboratories already deal with inconsistent requirements and multiple, uncoordinated government inspections, according to the AAAS letter. Some facilities can spend about $50,000 per inspection and today might undergo more than eight per year, the group said.
The letter also notes that few federal funds are directly allocated for operations, security or training at high-containment laboratories -- those that handle the most lethal pathogens -- meaning they must use general finances that could otherwise go to research.
Increasing the security mandates could heighten the burden, further hampering scientific effort.
Berger noted that lawmakers "tried to consciously minimize" the number of inspections by suggesting in the bill that government agencies conduct joint assessments.
The letter also expresses concern about policy discussions in both the executive and legislative branches about the design and implementation of personnel reliability programs at research facilities to evaluate whether an individual is trustworthy enough to work with sensitive material.
"In the absence of evidence that such programs can identify individuals likely to misuse biology, the overall costs to science, health and other national goals from implementing such a system appear to outweigh the assumed security benefits," the letter states.
The programs -- already employed by the Defense and Energy departments, among other agencies -- can include psychological screening, polygraph testing and credit checks.
The association recommended that Congress look to the National Institutes of Health, which recently developed a "biological surety" program that relies on fostering a network and culture of responsible conduct of research.
The group also suggested lawmakers consult with administrators and laboratory managers from a variety of research facilities on how a personnel reliability program and appeals process should be developed.