Delving Deeper: Everything You Wanted to Know About PHSBPRA (Part Two)

This is Part Two of our series on PHSBPRA – read the first part here.

By Yong-Bee Lim

III. The Public Health Security and Bioterrorism Preparedness Response Act of 2002: Purpose and Implementation

Part of the Bioterrorism Act of 2002 was meant to build on the precedent of the Patriot Act: the tradition of further defining and narrowing the scope in which individuals and institutions could legitimately have access and possess select biological agents. In fact, the Act greatly expanded upon previous legislation related to the possession, transport, and use of select agents. However, the Act also sought to make many improvements to the public health and emergency preparedness infrastructures.

The Act itself has five core titles. Four of these titles outline a plan to prepare for, respond to, and protect against biological agents. The last title, Title 28, is an additional amendment to the Public Health Services Act. While all of the titles involved in this particular piece of legislation have to do with public health emergency preparedness and bioterrorism, the two titles of greatest importance for this paper are those of Title 1 and Title Two: National Preparedness for Bioterrorism and Other Public Health Emergencies, and Enhancing Controls on Dangerous Biological Agents and Toxins, respectively.[1]

Title 1 of the Act highlights five goals that need to be addressed to achieve better national and public health preparedness. These goals include

  • Goal 1: “Providing effective assistance to state and local governments in the event of bioterrorism or some other public health emergency”
  • Goal 2: “Ensuring that state and local governments have appropriate capacity to detect and respond effectively to emergencies through effective public health surveillance and reporting mechanisms at state and local levels, appropriate laboratory readiness, properly trained and equipped personnel, proper health and safety protection of workers responding to emergencies, efficient coordination of health and mental health services during and after emergencies, and participation in communication networks that can effectively disseminate relevant information in a timely and secure manner to appropriate public and private entities”
  • Goal 3: “Developing and maintaining medical countermeasures (such as drugs, vaccines, and other biological products, medical devices, and other supplies) against biological agents and toxins that may be involved in acts of bioterrorism or other public health emergencies”
  • Goal 4: “Ensuring coordination and minimizing duplication of federal, state, and local planning, preparedness and response activities during investigation of a suspicious disease outbreak or other potential public health emergency”
  • Goal 5: “Enhancing the readiness of hospitals and other health care facilities to respond effectively to various types of emergencies”[2]

Title 2 of the Act gets more into fundamentally defining, expanding, and enhancing legal and accountability structures for select agents. This Title mandates:

  • “The formation of lists of biological agents and toxins that have the potential to pose severe threats to the public’s health and safety by the U.S. Department of Health and Human Services (HHS) and the Department of Agriculture (USDA)”
  • “The promulgation of regulations by HHS and USDA in establishing safety measures for select agents including proper training and appropriate skills to handle select agents and proper laboratory facilities to contain and dispose of the agents; the security of select agents to prevent their use in domestic and international terrorism; procedures to protect the public safety in the event of the transfer of such materials in violation of the act; and ensure the availability of biological agents and toxins for research, education and other legitimate purposes”
  • “The promulgation of regulations by HHS and USDA for the possession, use, and transfer of select agents, registration of individuals including provisions to ensure that persons register have a lawful purpose to possess, use, and transport the agents; and procedures to identify and characterize the agents held at a facility”
  • “Prompt notification of the release of a select agent outside the biocontainment area”
  • “The promulgation of regulations by HHS and USDA to ensure that appropriate ssafeguards and security arrangements for persons possession, using, or transferring the agents exist at a facility. Registered persons shall have their names and other identifying information submitted to the Department of Justice (DOJ). Access shall be denied to those identified as restrict persons; access shall be granted to only those individuals identified by the Secretaries of HHS, USDA, and DOJ; the DOJ shall use criminal, immigration, national security and other electronic databases to determine if a person is a restricted person or otherwise suspected of committing a crime, being involved in an organization that engages in domestic or international terrorism, or being an agent of a foreign power”
  • “That DOJ establishes penalties for violation of the Act”[3]

As seen in the act, a number of agencies are required to work independently, as well as in concert, to effectively implement the PHSBPRA. One such agency, the Department of Homeland Security (DHS), was originally crafted in November 2002 following the reorganization of 22 disparate Federal agencies. DHS’s mission is primarily responsible for protecting the nation and managing national emergency preparedness. Current manifestations of DHS’s role within the structure of the PHSBPRA includes Management Direct (MD) 026-03, which entrusts “the Undersecretary for Science and Technology at DHS with the responsibility of ensuring the proper implementation of and compliance with the statues and related regulations for the safeguard of select agents and toxins in activities conducted or sponsored by DHS.”[4]

Another key agency in the PHSBPRA is the Department of Health and Human Services (HHS). This agency, which had already been in existence, was designated as the primary federal agency responsible for implementing activities relating to public health and hospital emergency preparedness. To this end, HHS led itself and its partners to gradually move from a threat-based to an all-hazards approach of emergency preparedness.[5] In addition, the Bioterrorism Act vested new authorities concerning food safety and security within the domain of HHS. Intiatives such as the Strategic Partnership Program Initiative promoted collaboration between federal, state, and industry partners through the use of a vulnerability assessment tool to identify sector-wide vulnerabilities involving food security.[6]


Yong-Bee Lim is a PhD student in Biodefense at George Mason University. He holds a B.S. in Psychology and an M.S. in Biodefense from George Mason University as well. Contact him at ylim3@masonlive.gmu.edu or on Twitter @yblim3.

[1] “Bill Text: 107th Congress (2001 – 2002): HR 3448.ENR,” The Library of Congress (Thomas), accessed 01/16/2014, http://thomas.loc.gov/cgi-bin/query/F?c107:1:./temp/~c107EKVknu:e947:

[2] Ibid.

[3] Ibid.

[4] “MD Number 026-03: Select Agent and Toxin Security,” Department of Homeland Security: Directives System, accessed on 01/16/2014, http://www.dhs.gov/xlibrary/assets/foia/mgmt-directive-026-03-select-agent-and-toxin-security.pdf

[5] Secretary of HHS, Michael O. Leavitt, “On HHS Bioterrorism and Public Health Emergency Preparedness before the Committee on Health, Education, Labor and Pensions,” Testimony for the United States Senate at Washington, DC, March 16, 2006.

[6] Ibid.

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