[Congressional Record Volume 147, Number 158 (Thursday, November 15, 2001)]
[Senate]
[Page S11942]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]

      By Mr. HARKIN:
  S. 1706. A bill to provide for the enhanced control of biological 
agents and toxins; to the Committee on Health, Education, Labor, and 
Pensions.
  Mr. HARKIN. Mr. President, in May 1995, Larry Wayne Harris of Ohio 
ordered three vials of the bacterium that causes bubonic plague to be 
FedEx'ed from a company in Rockville, MD. At the time, all he needed 
was a credit card and letterhead. He invented both the letterhead and 
the lab he claimed to be from. In fact he was a member of a white 
supremacist group who would later tell of plans to kill hundreds of 
thousands of Americans with the plague. But when he was arrested with 
the vials, he was only charged with mail fraud for misrepresenting 
himself. No Federal license, registration, or even notification was 
required to obtain, own, or work with the plague.
  Partly as a result of this incident, Congress in 1996 passed 
provisions in the Antiterrorism and Effective Death Penalty Act to 
close the specific loophole. This bill required the Secretary of Health 
and Human Services to regulate transfer of a select list of biological 
agents. But it did not regulate possession or use of the agents. The 
subsequent regulations incorporated safety standards for labs receiving 
these agents, but set virtually no security standards to make sure 
these agents don't end in the wrong hands. They carved out broad 
exemptions, including all certified clinical laboratories. And they 
included little means of enforcement.
  I think most Americans would be shocked to learn that we still have 
no idea who has anthrax, plague, or other biological agents in their 
freezer. Labs have had to register only if they have sent or received 
one of the agents since 1996. We know the recent attacks with anthrax 
used the so-called ``Ames'' strain of anthrax, which was identified at 
Iowa State University some decades ago, but we don't know how many labs 
in the United States have samples of this strain today. If we had that 
information before the next attack, especially if a less common agent 
or strain were used, it could be the starting point for the next 
investigation.
  We can and we must do better. We have long had relatively tight 
controls on materials that can be used in nuclear weapons. You must 
have a license from the NRC or an agreement state to possess these 
nuclear materials. There are strict safety and security requirements on 
the licensees, and a small army of inspectors to make sure they comply. 
Licensees must report all shipments and receipts, and report any losses 
from their inventory of a gram or more of the most dangerous materials. 
Bioweapons have been called ``the poor man's nuclear bomb'' because 
they could cause similar devastation, but are easier and cheaper to 
obtain. It's time we place reasonable controls on biological agents 
too.
  That is why I am introducing the Bioweapons Control and Tracking Act 
of 2001. This bill would for the first time impose five important 
controls on dangerous biological agents and toxins to reduce the risk 
of an accident or terrorist attack. First, the bill would direct the 
Secretary of Health and Human Services to regulate the possession and 
use of select biological agents as well as their transfer.

  Second, the regulations would require registration with the 
Department for possession, use, and transfer of select agents and 
toxins. The registration would include known characterization of the 
agents, such as the strains, in order to facilitate their traceability. 
The Department would be required to maintain a database of locations 
and characterizations of the agents using the registration information.
  Third, the regulations would also have to include safeguards and 
security standards, as well as safety standards. Labs would be required 
to restrict access to the agents to people who need to handle them. And 
a process would be set up to screen people who do have access to the 
agents.
  Fourth, the bill requires that any exemptions from these regulations 
be consistent with public health and safety. Any exemptions from 
registration requirements would have to still allow a complete database 
of agents of concern, but exemptions could be allowed either for a lab 
that only temporarily possesses the agent or for samples that could not 
be useful for making a weapon. These exemptions are intended to avoid 
an unnecessary burden on thousands of clinical labs that receive 
diagnostic samples for testing and, if the test is positive for a 
select agent, quickly pass the sample on to a government lab or destroy 
it.
  Fifth, the bill includes strong enforcement measures. The bill 
specifically authorizes inspections to ensure compliance. To give teeth 
to the enforcement, it enacts a civil penalty for violating the 
regulations of up to $250,000 for an individual of $500,000 for a 
group. And it enacts a criminal penalty up to 5 years in prison for 
possession or transfer of select agents by someone who is not 
registered, and also for transfer to a person who is not registered.
  In addition, the bill exempts information about specific labs from 
disclosure under the Freedom of Information Act to prevent one-stop-
shopping for information by would-be bioterrorists. It requires 
biennial review of the list of biological agents and toxins of concern. 
And it codifies the law in Public Health Service Act, maintains current 
regulations until the Secretary issues new ones, and sets a deadline 
for the registration and associated penalties.
  I have been working with several of my colleagues on a $4 billion 
package to strengthen our response to a possible bioterrorism attack, 
so that we can stop a terrible attack from becoming a national or world 
calamity. We need these funds to strengthen the public health 
infrastructure, monitor food safety, and build our capacity for 
vaccinations. But for just a few millions dollars we may be able to 
prevent an attack, to stop bioterrorists before they even get hold of 
the necessary agents. We must no delay.
                                 ______