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  • Sec. 817
  • Restricted Persons
  • Biological Agent, Toxin, or Delivery System


As part of its response to the events of September 11, 2001, Congress passed the USA Patriot Act. The Act became effective immediately upon being signed into law by the President on October 26, 2001. Part of the Act expands restrictions on the possession, use and access to biological agents, toxins and delivery systems.

Prior to the Act, federal law prohibited the development, production, transfer or possession of any biological agent, toxin, or delivery system for use as a weapon (18 USC Section 175). The Act greatly expands the law by now prohibiting possession of a 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. Thus, researchers at Penn must have a reasonable justification for the type and quantity of biological agents, toxins or delivery systems they possess. Penalties for non-compliance include imprisonment up to ten years and large fines. Anyone possessing these materials must provide a reasonable justification and immediately complete a Select Agent Registration Form, available by contacting Penn's Office of Environmental Health and Radiation Safety (215-898-4453) or at the office web site.

The Act also creates restrictions on access to certain materials. “Restricted persons” may not possess, ship, transport or receive any biological agent or toxin that is listed as a “select agent.” Penn’s Office of Environmental Health and Radiation Safety is in charge of ensuring that all “select agents” at Penn are accounted for and kept/used/disposed of in compliance with previously enacted federal law. (For more information on select agent registration, as well as a list of select agents, go to Select Agents Overview).

“Restricted persons”, who are now prohibited from having access to select agents, means any individual who:
(A) is under indictment for a crime punishable by imprisonment for a term exceeding 1 year;
(B) has been convicted in any court of a crime punishable by imprisonment for a term exceeding 1 year;
(C) is a fugitive from justice;
(D) is an unlawful user of any controlled substance (as defined in section 102 of the Controlled Substances Act (21 U.S.C. 802));
(E) is an alien illegally or unlawfully in the United States;
(F) has been adjudicated as a mental defective or has been committed to any mental institution;
(G) is an alien (other than an alien lawfully admitted for permanent residence ) who is a national of Cuba, Iran, Iraq, Libya, North Korea, Sudan or Syria, or any other country to which the Secretary of State, pursuant to applicable law, has made a determination (that remains in effect) that such country has repeatedly provided support for acts of international terrorism; or
(H) has been discharged from the Armed Services of the United States under dishonorable conditions.

If you meet any of the above criteria (A through H), you fit the definition of a restricted person. Individuals who are restricted persons and who have access to any laboratory or other facility that may contain a select agent must immediately notify the Office of Environmental Health and Radiation Safety and the individual in charge of the laboratory or other facility. Penn will attempt to cause the least inconvenience to any restricted person, while still taking steps to comply with the Act.

If you are unsure whether you are a restricted person under the Act, whether certain materials are select agents, or any other questions concerning the USA Patriot Act, please contact the Office of Environmental Health and Radiation Safety at (215) 898-4453.

As used here - (1) the term ''biological agent'' means any micro-organism, virus, infectious substance, or biological product that may be engineered as a result of biotechnology, or any naturally occurring or bioengineered component of any such microorganism, virus, infectious substance, or biological product, capable of causing -
(A) death, disease, or other biological malfunction in a human, an animal, a plant, or another living organism;
(B) deterioration of food, water, equipment, supplies, or material of any kind; or
(C) deleterious alteration of the environment;

(2) the term ''toxin'' means the toxic material of plants, animals, microorganisms, viruses, fungi, or infectious substances, or a recombinant molecule, whatever its origin or method of production, including -
(A) any poisonous substance or biological product that may be engineered as a result of biotechnology produced by a living organism; or
(B) any poisonous isomer or biological product, homolog, or derivative of such a substance;

(3) the term ''delivery system'' means -
(A) any apparatus, equipment, device, or means of delivery specifically designed to deliver or disseminate a biological agent, toxin, or vector; or
(B) any vector;

(4) the term ''vector'' means a living organism, or molecule, including a recombinant molecule, or biological product that may be engineered as a result of biotechnology, capable of carrying a biological agent or toxin to a host; and

(5) the term ''national of the United States'' has the meaning prescribed in section 101(a)(22) of the Immigration and Nationality Act (8 U.S.C. 1101(a)(22)).

The term ''alien'' means any person not a citizen or national of the United States.

The term ''lawfully admitted for permanent residence'' means the status of having been lawfully accorded the privilege of residing permanently in the United States as an immigrant in accordance with the immigration laws, such status not having changed.

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