Factsheet

Veterinary Services December 2002

APHIS

Q’s and A’s About the

Agricultural

Bioterrorism

Protection Act of

2002

Q. What is the Agricultural Bioterrorism

Protection Act of 2002?

A. The Agricultural Bioterrorism Protection Act of

2002 is a subpart of the Public Health Security and

Bioterrorism Preparedness Response Act of 2002,

which was signed into law by the President on June

12, 2002. Both require that entities, such as private,

State, and Federal research laboratories, universities,

and vaccine companies, that possess, use, or transfer agents or toxins deemed a threat to public health

or animal or plant health or products register these

agents with the appropriate Federal Department.

Q. Under these Acts, what Departments are

responsible for regulating the possession of

these agents and toxins?

A. Under the Agricultural Bioterrorism Protection Act,

entities that possess, use, or transfer agents or toxins deemed a severe threat to animal or plant health

or products must notify and register with the

Secretary of the U.S. Department of Agriculture

(USDA). USDA’s Animal and Plant Health Inspection

Service (APHIS) has been designated by the

Secretary as the Agency for implementing the provisions of the law for USDA.

Under the Public Health Security and

Bioterrorism Preparedness Response Act, entities

that possess, use, or transfer toxins or agents

deemed a threat to public health must register with

the Secretary of the U.S. Department of Health and

Human Services (HHS). The Centers for Disease

Control and Prevention (CDC) has been designated

by the HHS Secretary as the Agency for implementing the provisions of the law for HHS. 

Q. Why was the law enacted?

A. The law is designed to improve the ability of the

United States to prevent, prepare for, and respond to

bioterrorism and other public health emergencies that

could threaten public safety or American agriculture. 

Q. What agents or toxins pose a severe threat to

animal or plant health and or products?

A. The list of agents and toxins deemed to pose a

severe threat to animal or plant health or products is

published in the December 13, 2002, Federal

Register. To see the text, go to

http://www/aphis.usda.gov/vs/ncie/bta.html. The

agents and toxins that pose a severe threat to animal health have been designated “high consequence

livestock pathogens and toxins.” 

Q. What were the criteria used to determine

whether an agent or toxin should be on the

USDA list?

A. In determining whether an agent or toxin should

be included on the USDA list, the following were

considered:

• The effect of an agent or toxin on animal or plant

health or products. 

• The virulence of an agent or degree of toxicity of

the toxin and the methods by which the agents or

toxins are transferred to animals or plants.

• The availability and effectiveness of medicines and

vaccines to treat and prevent any illness caused by

an agent or toxin. 

Q. What agents or toxins are deemed a severe

threat to public health?

A. The agents and toxins deemed a severe threat to

public health (select agents) are published in the

December 13, 2002, Federal Register. To see the

text, go to http://www/cdc.gov. These agents and

toxins fall under the responsibility of HHS.

Q. What are “overlap agents?”

A. Some of the agents and toxins that pose a

severe threat to animal health and animal products

also pose a severe threat to public health. As such,

these agents and toxins also appear on both the

HHS and the USDA’s lists of agents and toxins and

have been designated “overlap agents” since both

USDA and HHS have regulatory authority over them. 

Q. Who is affected by the new regulations?

A. Anyone possessing, using, or transferring any

“select agents,” “high consequence livestock

pathogens and toxins,” and/or agents or toxins

deemed a severe threat to plant health and plant

products are affected by the new regulations. Some

examples include private, State, and Federal

research laboratories; universities; and vaccine

companies. 
Q. What are these entities required to do and

when?

A. Entities in possession of any of the USDA “high

consequence livestock pathogens,” toxins, or listed

plant agents were required to provide a “notification of

possession” to the Secretary of Agriculture by

October 11, 2002. Entities in possession of any of

the HHS select agents were required to provide notification of possession to the HHS Secretary by

September 10, 2002.

Entities have until March 12, 2003, to apply to

register their facilities with either APHIS or CDC.

Controls to restrict access to the agents and toxins

must be in place by February 2003. Capital improvements and other physical security requirements

necessary to bring facilities into full compliance must

be completed by September 12, 2003.

Registration of an entity requires that the U.S.

Department of Justice (DOJ) complete a security risk

assessment for the facility, its owners, and the designated responsible official. Before registration is

granted, the facility must also meet biosafety requirements that are commensurate with the risk that the

agent or toxin poses and must establish security

measures that provide graded protection in accordance with the threat that the agent or toxin poses.

Q. How do these new registration requirements

differ from existing regulations?

A. APHIS’ Veterinary Services program has regulated overlap and animal-specific agents and toxins as

"organisms and vectors," just as APHIS’ Plant

Protection and Quarantine program has regulated

plant-specific agents and toxins as "plant pests." In

both cases, the existing regulations focus on addressing the risks associated with the importation and interstate movement of specific organisms. Generally

speaking, these regulations prohibit the importation

into the United States or interstate movement within

the United States of organisms, vectors, and plant

pests unless a permit has been issued by APHIS

authorizing their importation or interstate movement.

In addition, these existing regulations require that the

importation or interstate movement be carried out in

accordance with the safeguards and other requirements assigned as conditions of the permit, such as

requirements for packaging during transport and safeguards to ensure the adequate containment of the

organisms, vectors, or pests at their destination.

The requirements of the new Act build on these

existing regulations. For example, where the existing

regulations cover importation and interstate movement, the new rule also covers movement within a

State as well as possession (cases where no movement is involved). Similarly, where permit requirements under the existing regulations focus on the animal or plant health risks associated with organisms,

vectors, and plant pests, the new rule also contains

registration and security requirements that will

advance the goal of preventing access to listed

agents and toxins for use in domestic or international

terrorism or for any other criminal purpose.

Q. Are there any exemptions to the new registration requirements?

A. Entities such as pharmacies, clinics, and hospitals that exclusively possess products that contain

any of these agents or toxins and that are cleared,

approved, licensed, or registered under any of the

Acts listed below are exempt from the registration

requirement:

• Federal Food, Drug, and Cosmetic Act

• Section 351 of the Public Health Service Act

• Virus-Serum-Toxin Act 

• Federal Insecticide, Fungicide, and Rodenticide Act

Clinical and diagnostic facilities that do not maintain viable agents or active toxins are exempt from

the registration requirements provided that they notify APHIS of the identification of the agent and toxin

and then either destroy it or transfer the agent or

toxin within 7 days of identification. For overlap

agents, a clinical or diagnostic facility must notify

either APHIS or CDC.

APHIS will determine on a case-by-case basis

whether certain investigational products that contain

“high consequence livestock pathogens and toxins”

pose no threat to animal health or animal products

and may be exempted. 

Q. How can a facility register?

A. An “Application for Laboratory Registration for

Possession, Use, and Transfer of Select Agents or

High Consequence Livestock Pathogens and Toxins”

should be completed and submitted to CDC for

agents and toxins on the HHS list or to APHIS for

agents and toxins on USDA’s list. Applications must

be submitted to either CDC or APHIS for overlap

agents. The DOJ security risk assessment of the

entity, its owners, and the responsible official should

also be completed and submitted to DOJ.

Q. Do entities that possess overlap agents need

to be registered with both USDA and HHS?

A. An entity/facility that needs to register in order to

possess, use, or transfer an overlap agent must submit its registration information to either APHIS or

CDC, but is not required to submit the application to

both APHIS and CDC.

Q. What is the penalty for noncompliance under

the new regulations?

A. Entities found to possess select agents or “high

consequence livestock pathogens and toxins” that

are not registered with either CDC or APHIS are
Q. Where can applicants get additional information?

A. For animal agents and toxins on the USDA list,

the applicant should contact APHIS at 301-734-5960

(facsimile: 301-734-3652). For HHS agents and toxins, the applicant should contact CDC at 404-498-

2255 (facsimile: 404-498-2265). For HHS/USDA

overlap agents, the applicant should contact either

APHIS or CDC at the numbers above. 

For plant agents and toxins, the applicant should

contact APHIS at 301-734-5519 (facsimile: 301-734-

8700). 

A listing of USDA animal agents and toxins is

available at

http://www.aphis.usda.gov/vs/ncie/bta.html. The list

of plant agents and toxins is available at

http://www.aphis.usda.gov/ppq/permits. A listing of

HHS select biological agents and toxins is available

at http://www.cdc.gov. You may also contact

USDA/APHIS by e-mailing your question to

vs_content_management@aphis.usda.gov. 

The U.S. Department of Agriculture (USDA) prohibits discrimination in all its programs and activities on the basis of race, color,

national origin, sex, religion, age, disability, political beliefs, sexual

orientation, or marital or family status. (Not all prohibited bases

apply to all programs.) Persons with disabilities who require alternative means for communication of program information (Braille,

large print, audiotape, etc.) should contact USDA’s TARGET

Center at (202) 720–2600 (voice and TDD).

To file a complaint of discrimination, write USDA, Director, Office

of Civil Rights, Room 326–W, Whitten Building, 1400

Independence Avenue, SW, Washington, DC 20250–9410 or call

(202) 720–5964 (voice and TDD). USDA is an equal opportunity

provider and employer.

subject to a fine of $500,000 for the entity and

$250,000 and/or imprisonment for up to 5 years for

an individual. These penalties also apply to an entity

or individual transferring any of these agents or toxins

to a nonregistered entity.

Q. Where can applicants get the forms associated

with the Agricultural Bioterrorism Protection Act

of 2002?

A. Copies of the forms may be printed from the

APHIS Web site at

http://www.aphis.usda.gov/vs/ncie/bta.html or the

CDC Web site at http://www.cdc.gov. APHIS and

CDC have developed joint reporting systems so that

the same forms may used for either Agency.

Q. Where should registration applications be

sent?

A. For USDA animal agents, submit documents to:

National Center for Import and Export, VS, APHIS,

4700 River Road Unit 40, Riverdale, MD 20737-

1231. For HHS/USDA overlap agents submit the

forms to either CDC or APHIS. For USDA plant

agents and toxins, return completed forms to:

Biological and Technical Services, PPQ, APHIS, 4700

River Road Unit 133, Riverdale, MD 20737-1236.

For HHS agents, submit applications to: Centers for

Disease Control and Prevention, Select Agent

Program, 1600 Clifton Rd. NE, Mailstop E-79, Atlanta,

GA 30333. 

United States Department of Agriculture • Animal and Plant Health Inspection Service • Safeguarding American Agriculture