Protecting U.S. Agriculture From Bioterrorism

The U.S. Department of Agriculture’s (USDA) Animal 

and Plant Health Inspection Service (APHIS) works 

to ensure the continued health, welfare, and value 

of our Nation’s agriculture and natural resources. As 

part of this safeguarding mission, we help protect 

U.S. animal and plant health by overseeing the 

possession, use, and transfer of potentially damaging 

biological agents and toxins, which we refer to as 

“select agents.” 

APHIS’ Agriculture Select Agent Services (AgSAS) 

carries out this work in our agency’s security and 

bioterrorism preparedness efforts. Along with the 

Division of Select Agents and Toxins (DSAT), a 

parallel program through the U.S. Department of 

Health and Human Services’ Centers for Disease 

Control and Prevention (CDC), we make up the 

Federal Select Agent Program (FSAP). AgSAS also 

regulates the import and interstate transport of other 

infectious organisms and agents (non-select agents) 

that can carry and pass on animal disease. 

Federal Select Agent Program

AgSAS oversees governmental, academic, and 

commercial sector organizations that possess, use, 

or transfer select agents that could pose a severe 

threat to animal and plant health or animal and plant 

products. DSAT covers select agents that could pose 

a severe threat to public health and safety. Select 

agents that threaten both public and animal health 

(such as anthrax) or can be passed from animals to 

people are regulated by both AgSAS and DSAT. 

The list of all regulated select agents is reviewed 

and updated at least every 2 years. To view the 

current list, go to www.selectagents.gov/Select%20

Agents%20and%20Toxins%20List.html.

Inspections

Any organizations that want to possess or use a select 

agent must be inspected by FSAP to make sure they 

comply with all select agent regulatory requirements. 

During these in-depth assessments, inspectors:

• confirm the facility has appropriate safety and 

security measures in place to deter the theft, 

loss, or release of select agents;

• verify that laboratory workers are adequately 

trained to work safely with the select agents; and

• ensure that the facility maintains accurate records.

After a review of the facility’s application and a 

successful inspection, the facility is registered with 

FSAP. It must then continue to pass all compliance 

inspections to maintain its registration. This includes 

an announced renewal inspection every 3 years, 

as well as an annual unannounced compliance 

inspection (conducted by AgSAS) in between the 

3-year renewal inspection cycle. Other inspections 

may be required if an amendment to the registration 

is submitted for adding new laboratories, buildings, 

and/or select agents of a higher risk. 

Guidance

FSAP provides guidance and support to help 

regulated groups and companies understand 

and meet the select agent requirements. Up-todate information and resources can be found at 

www.selectagents.gov. These include: guidance 

documents, checklists based on regulations and 

national standards, inspection videos, and an email 

link for questions or requests.

FSAP also hosts annual workshops to help program 

participants understand their legal responsibilities for 

complying with the select agent regulations.

ANIMAL AND PLANT HEALTH INSPECTION SERVICE SEPTEMBER 2014 

APHIS and 

CDC work 

together to 

protect against 

bioterrorism 

by overseeing 

the possession, 

use, and 

transfer of 

select agents.

VETERINARY SERVICES
Working With Federal Partners

FSAP works closely with the U.S. Department 

of Justice to identify people who cannot access 

regulated select agents, based on the restrictions 

under Title 42, section 262a and Title 7, section 

8401 of the United States Code (42 USC 262a and 

7 USC 8401). To ensure the safe handling and 

use of select agents, FSAP also joins forces with 

numerous other Federal partners:

• Infrastructure Protection Program, within the 

U.S. Department of Homeland Security (DHS), 

identifies potential vulnerabilities and threats 

to registered entities in the United States.

• U.S. Department of Transportation (DOT) 

determines whether entities transferring select 

agents are complying with DOT regulations.

• Federal Bureau of Investigation conducts 

criminal investigations on the potential misuse 

or illegal acquisition of select agents.

• DHS’ Science and Technology Directorate 

provides compliance support and oversight 

for registered DHS entities and select agent 

activities conducted or sponsored by DHS.

• U.S. Department of the Army Inspector 

General’s Technical Inspections Division 

conducts general, compliance-oriented 

inspections of chemical, biological, 

radiological, nuclear, and other technical 

operations.

• U.S. Department of Veterans Affairs’ (VA) 

Office of Research Oversight handles all 

matters of VA research compliance and 

assurance, including protection of human 

research subjects; laboratory animal 

welfare; research safety, laboratory security, 

information security, and misconduct; 

and governmentwide debarment for 

research impropriety. 

Organism and Vectors Import/

Transport Permit Program

AgSAS’ Organism and Vector (OV) Import/Transport 

Permit Program regulates the import and interstate 

transport of infectious biological agents, infectious 

substances, and organisms that can carry and pass 

on animal disease. To issue a permit, OV reviews 

the permit application and may inspect the group 

or company’s facilities to make sure they can safely 

handle these materials. Importation permits are 

issued only to the importer, who must be located 

in the United States. To be successfully inspected, 

cleared, and released at U.S. ports of entry by DHS’ 

Customs and Border Protection, these imported 

items must be accompanied by valid USDA import 

permits and have proper packaging and labeling.

OV also collaborates with CDC’s Import Permit 

Program, which is charged with preventing 

the introduction, transmission, or spread of 

communicable diseases from foreign countries 

into the United States.

To learn more, go to or contact:

www.selectagents.gov

Agriculture Select Agent Services

National Import Export Services

4700 River Road, Unit 2

Riverdale, MD 20737

Phone: (301) 851-3300 option 3

Fax: (301) 734-3652

Email: AgSAS@aphis.usda.gov or 

 OV@aphis.usda.gov

USDA is an equal 

opportunity provider 

APHIS 91-75-001 and employer.