Research Laboratories, Selected Agents, and Restricted Persons
Date: March 18, 2005
Source: The Centers for Disease Control and Prevention
About the Author: The Centers for Disease Control and Prevention (CDC) regulates "the possession, use, and transfer of select agents and toxins that have the potential to pose a severe threat to public health and safety. The CDC Select Agent Program oversees these activities and registers all laboratories and other entities in the United States of America that possess, use, or transfer a select agent or toxin." The U.S. Departments of Health and Human Services (HHS) and Agriculture (USDA) published final rules for the possession, use, and transfer of select agents and toxins (42 C.F.R. Part 73, 7 C.F.R. Part 331, and 9 C.F.R. Part 121) in the Federal Register on March 18, 2005.
The USA PATRIOT Act (commonly called the Patriot Act) is an acronym for the Uniting and Strengthening America by Providing Appropriate Tools Required to Intercept and Obstruct Terrorism Act of 2001. The bill was signed into law by President George W. Bush on October 26, 2001. According to the Act, research facilities that handle certain chemical and biological agents were required to institute new employee screening and security procedures.
The Patriot Act was introduced to improve counterterrorism efforts by providing law enforcement with new tools to detect and prevent terrorism. Section 817 of the USA Patriot Act is titled "Expansion of the Biological Weapons Statute" and expands on chapter 10 of title 18 in the United States Code, providing new laws designed to prevent terrorist acts involving biological weapons.
The specific changes made by the Patriot Act include making it unlawful to possess biological agents, toxins, or delivery systems unless there is a reasonably justified purpose and making it unlawful for a restricted person to possess biological agents, toxins, and delivery systems that are classified as select agents.
The Patriot Act defines a biological agent as any microorganism or infectious substance that: can cause death or disease to humans, plants, or animals; can cause deterioration of food, water, supplies, or other material; or can cause damage to the environment. A toxin is defined as any toxic material or infectious substance. A delivery system is defined as any apparatus, equipment, device, or means of delivery specifically designed to deliver or disseminate a biological agent, toxin or vector. By limiting possession of biological agents, toxins, and delivery agents, the Patriot Acts seeks to prevent terrorist acts involving biological weapons.
The Patriot Act defines a restricted person as anyone who: (A) is under indictment for a crime punishable by imprisonment for a term greater than one year; (B) has been convicted of a crime punishable by imprisonment for a term greater than one year; (C) is a fugitive from justice; (D) is an unlawful user of any controlled substance; (E) is an alien illegally or unlawfully in the United States; (F) is mentally defective or has been committed to any mental institution; (G) is an alien who is a national of a country that the U.S. Secretary of State has determined to be a repeated provider of support for acts of international terrorism; or (H) has been discharged from the Armed Services of the United States under dishonorable conditions.
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Section 175 of Chapter 10 of the United States Code describes the prohibitions related to biological weapons. Section 175 of the statute states that, "Whoever knowingly develops, produces, stockpiles, transfers, acquires, retains, or possesses any biological agent, toxin, or delivery system for use as a weapon, or knowingly assists a foreign state or any organization to do so, or attempts, threatens, or conspires to do the same, shall be fined under this title or imprisoned for life or any term of years, or both."
The Patriot Act did not change the above section of the statute. However, it did add an additional offense, which states that, "Whoever knowingly possesses any biological agent, toxin, or delivery system of a type or in a quantity that, under the circumstances, is not reasonably justified by a prophylactic, protective, bona fide research, or other peaceful purpose, shall be fined under this title, imprisoned not more than 10 years, or both."
The expansion that is made with the USA Patriot Act is that it becomes unlawful to possess biological agents, toxins, or delivery systems if that possession is not for a justified purpose. In contrast, the previous United States Code made it unlawful to possess biological agents, toxins, or delivery systems for use as a weapon. This change places a demand on organizations to ensure that the possession of any biological agents, toxins, or delivery systems is justified.
The USA Patriot Act also added Section 175b, which limits the possession of select agents by restricted persons. This states that, "No restricted person shall ship or transport in or affecting interstate or foreign commerce, or possess in or affecting inter-state or foreign commerce, any biological agent or toxin, or receive any biological agent or toxin that has been shipped or transported in interstate or foreign commerce, if the biological agent or toxin is listed as a select agent in Appendix A of part 72 of title 42, Code of Federal Regulations." This addition to the law places demands on organizations possessing select agents to ensure they are not accessed by restricted persons.
Laboratories that operate within the United States or that are funded by the United States must comply with the new regulations regarding prohibiting access to selected agents by restricted persons. Each organization is required to develop their own screening or application forms to obtain the required information on persons working (or seeking work) in their laboratories in order to certify their right to access selected agents.
Office of the Law Revision Counsel. 18 USC CHAPTER 10 "BIOLOGICAL WEAPONS." <http://uscode.house.gov/download/pls/18C10.txt> (accessed July 2, 2005).
Library of Congress. "H.R.3162: Uniting and Strengthening America by Providing Appropriate Tools Required to Intercept and Obstruct Terrorism (USA PATRIOT ACT) Act of 2001." <http://thomas.loc.gov/cgi-bin/query/D?c107:4:./temp/~c107rEAiyQ:> (accessed July 2, 2005).