DEFINITIONS.“In this chapter:
“(1)Biological weapons convention.—
The term ‘Biological Weapons Convention’ means the 1972 Convention on the Prohibition of the Development, Production and Stockpiling of Bacteriological (Biological) and Toxin Weapons and on their Destruction.
The term ‘compliance protocol’ means that segment of a bilateral or multilateral agreement that enables investigation of questions of compliance entailing written data or visits to facilities to monitor compliance.
The term ‘industry’ means any corporate or private sector entity engaged in the research, development, production, import, and export of peaceful pharmaceuticals and bio-technological and related products.
FINDINGS.“Congress makes the following findings:
The threat of biological weapons and their proliferation is one of the greatest national security threats facing the United States.
The threat of biological weapons and materials represents a serious and increasing danger to people around the world.
Biological weapons are relatively inexpensive to produce, can be made with readily available expertise and equipment, do not require much space to make and can therefore be readily concealed, do not require unusual raw materials or materials not readily available for legitimate purposes, do not require the maintenance of stockpiles, or can be delivered with low-technology mechanisms, and can effect widespread casualties even in small quantities.
Unlike other weapons of mass destruction, biological materials capable of use as weapons can occur naturally in the environment and are also used for medicinal or other beneficial purposes.
Biological weapons are morally reprehensible, prompting the United States Government to halt its offensive biological weapons program in 1969, subsequently destroy its entire biological weapons arsenal, and maintain henceforth only a robust defensive capacity.
The Senate gave its advice and consent to ratification of the Biological Weapons Convention in 1974.
The Director of the Arms Control and Disarmament Agency explained, at the time of the Senate’s consideration of the Biological Weapons Convention, that the treaty contained no verification provisions because verification would be ‘difficult’.
A compliance protocol has now been proposed to strengthen the 1972 Biological Weapons Convention.
The resources needed to produce, stockpile, and store biological weapons are the same as those used in peaceful industry facilities to discover, develop, and produce medicines.
The raw materials of biological agents are difficult to use as an indicator of an offensive military program because the same materials occur in nature or can be used to produce a wide variety of products.
Some biological products are genetically manipulated to develop new commercial products, optimizing production and ensuring the integrity of the product, making it difficult to distinguish between legitimate commercial activities and offensive military activities.
Only a small culture of a biological agent and some growth medium are needed to produce a large amount of biological agents with the potential for offensive purposes.
The United States pharmaceutical and biotechnology industries are a national asset and resource that contribute to the health and well-being of the American public as well as citizens around the world.
One bacterium strain can represent a large proportion of a company’s investment in a pharmaceutical product and thus its potential loss during an arms control monitoring activity could conceivably be worth billions of dollars.
Biological products contain proprietary genetic information.
The proposed compliance regime for the Biological Weapons Convention entails new data reporting and investigation requirements for industry.
A compliance regime which contributes to the control of biological weapons and materials must have a reasonable chance of success in reducing the risk of production, stockpiling, or use of biological weapons while protecting the reputations, intellectual property, and confidential business information of legitimate companies.
TRIAL INVESTIGATIONS AND TRIAL VISITS.
“(a)National Security Trial Investigations and Trial Visits.—
The President shall conduct a series of national security trial investigations and trial visits, both during and following negotiations to develop a compliance protocol to the Biological Weapons Convention, with the objective of ensuring that the compliance procedures of the protocol are effective and adequately protect the national security of the United States. These trial investigations and trial visits shall be conducted at such sites as United States Government facilities, installations, and national laboratories.
“(b)United States Industry Trial Investigations and Trial Visits.—
The President shall take all appropriate steps to conduct or sponsor a series of United States industry trial investigations and trial visits, both during and following negotiations to develop a compliance protocol to the Biological Weapons Convention, with the objective of ensuring that the compliance procedures of the protocol are effective and adequately protect the national security and the concerns of affected United States industries and research institutions. These trial investigations and trial visits shall be conducted at such sites as academic institutions, vaccine production facilities, and pharmaceutical and biotechnology firms in the United States.
“(c)Participation by Defense Department and Other Appropriate Personnel.—The Secretary of Defense and, as appropriate, the Director of the Federal Bureau of Investigation shall make available specialized personnel to participate—
in each trial investigation or trial visit conducted pursuant to subsection (a); and
in each trial investigation or trial visit conducted pursuant to subsection (b), except for any investigation or visit in which the host facility requests that such personnel not participate,
for the purpose of assessing the information security implications of such investigation or visit. The Secretary of Defense, in coordination with the Director of the Federal Bureau of Investigation, shall add to the report required by subsection (d)(2) a classified annex containing an assessment of the risk to proprietary and classified information posed by any investigation or visit procedures in the compliance protocol.
“(1)In general.—The President shall conduct a study on the need for investigations and visits under the compliance protocol to the Biological Weapons Convention, including—
an assessment of risks to national security and United States industry and research institutions of such on-site activities; and
an assessment of the monitoring results that can be expected from such investigations and visits.
“(2)Report.—Not later than the date on which a compliance protocol to the Biological Weapons Convention is submitted to the Senate for its advice and consent to ratification, the President shall submit to the Committee on Foreign Relations of the Senate a report, in both unclassified and classified form, setting forth—
the findings of the study conducted pursuant to paragraph (1); and
the results of trial investigations and trial visits conducted pursuant to subsections (a) and (b).”