Research @ U I C

Frequently Asked Questions

1. What is a select agent?
Select agents is a term used by the government to indicate specifically regulated pathogens and toxins. Both the Department of Health and Human Services acting through the Centers for Disease Control (HHS-CDC) and the United States Department of Agriculture (USDA) acting through the Animal and Plant Health Inspection Service (APHIS) maintain lists of such pathogens and toxins. Some agents appear on both lists and are termed overlapping agents—current alphabetical list of all select agents and toxins. Agents are listed in the far left column. The agents on this list are thought to pose a threat as potential weapons of bioterrorism and/or could represent a severe threat to human health and safety and animal or plant health and/or products . The use, possession, and transfer of these agents is regulated by the federal government. Several laws and government regulations are applicable to these agents and these a listed below.

2. What is the difference between exclusion and exemption? How do I know if my research qualifies for an exclusion from select agent registration?
Exclusion refers to the specific list of agents or toxins indicated below which appear on the select agents lists, but under the conditions listed below are excluded form select agent registration.

Any select agent or toxin that is in its naturally occurring environment provided it has not been intentionally introduced, cultivated, collected, or otherwise extracted from its natural source. Should an investigator find that any select agent or toxin has been inadvertently isolated, they should immediately contact EHSO (312-996-7411) for instructions as to what to do with the agent.

Non-viable select agent organisms or nonfunctional toxins.

Fixed tissues that bear or contain select agents or toxins.

Genetic elements or sub-units of agents or toxins, if the genetic elements or sub-units are not capable of causing disease.

The vaccine strain of Junin virus (Candid #1).

The vaccine strain of Rift Valley fever virus (MP-12).

Venezuelan Equine Encephalitis virus vaccine strain TC-83.

Venezuelan Equine Encephalitis (VEE) virus vaccine candidate strain V3526.

Bacillus anthracis

strains devoid of both plasmids pX01 and pX02.
strains devoid of the plasmid pX02 (e.g., Bacillus anthracis Sterne, pX01+pX02-).

Brucella abortus strain RB51 (vaccine strain)

Francisella tularensis:

subspecies novicida (also referred to as Francisella novicida) strain, Utah 112 (ATCC 15482).
subspecies holartica LVS (live vaccine strain; includes NDBR 101 lots, TSI-GSD lots, and ATCC 29684).
ATCC 6223 (also known as strain B38).

Yersinia pestis:

strains which are Pgm- due to a deletion of a 102-kb region of the chromosome termed the pgm locus (i.e., ?pgm). Examples are Y. pestis strain E.V. or various substrains such as EV 76.
strains (e.g., Tjiwidej S and CDC A1122) devoid of the 75 kb low-calcium response (Lcr) virulence plasmid.

The following toxins (in the purified form or in combinations of pure and impure forms) if the aggregate amount under the control of a principal investigator does not, at any time, exceed the amount specified:

100 mg of Abrin
0.5 mg of Botulinum neurotoxins
100 mg of Clostridium perfringens epsilon toxin
100 mg of Conotoxins. Conotoxins specifically excluded are:
- the class of sodium channel antagonist µ-conotoxins, including GIIIA;
- the class of calcium channel antagonist ?-conotoxins, including GVIA, GVII, MVIIA, MVIIC, and their analogs or synthetic derivatives;
- the class of NMDA-antagonist conantokins, including con-G, con-R, con-T and their analogs or synthetic derivatives;
- the putative neurotensin agonist, contulakin-G and its synthetic derivatives.
1,000 mg of Diacetoxyscirpenol
100 mg of Ricin
100 mg of Saxitoxin
100 mg of Shigatoxin
100 mg of Shiga-like ribosome inactivating proteins
5 mg of Staphylococcal enterotoxins
100 mg of Tetrodotoxin
1,000 mg of T-2 toxin

Exemptions are found in 42 CFR 73.6 and were mandated by law and require that an entity file an exemption request with either the CDC or USDA. Only those entities that fall under these categories can apply for an exemption:

Entities that only conduct activities related to diagnosis, verification, or proficiency testing. If certain select agents are identified as the result of diagnosis or verification, the entity must immediately report it to the HHS/CDC or the USDA and either transfer the agent or destroy it.

Entities 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:

i. Federal Food, Drug, and Cosmetic Act
ii. Section 351 of the Public Health Service Act
iii. Virus-Serum-Toxin Act
iv. Federal Insecticide, Fungicide, and Rodenticide Act

Exemption involving Investigational Products

Exemption regarding Domestic or Foreign Public Health Emergency

Exemption based on Agriculture Emergency

3. What is the relationship between risk groups, biosafety levels, NIAID or CDC priority categories, restricted agents and select agents?
Depending on which documents are under review, the above mentioned terms may be used. Listed below is an explanation of the terminology and how these terms relate to one another.

Risk Groups - This is the classification assigned to microorganisms based on their relative pathogenicity to healthy adult humans by the NIH Guidelines for Research involving Recombinant DNA Molecules (NIH Guidelines). There are 4 groups. They are as follows:

Risk Group 1 - Agents not associated with disease in healthy adult humans
Risk Group 2 - Agents associated with human disease which is rarely serious and for which preventive or therapeutic interventions are often available.
Risk Group 3 - Agents associated with serious or lethal human disease for which preventive or therapeutic interventions may available (high individual risk low but low community risk).
Risk Group 4 - Agents likely to cause serious or lethal human disease for which preventative or therapeutic interventions are not usually available (high individual and high community risk).

A list of microorganisms classified by risk group can be found in Appendix B of the NIH Guidelines. There are numerous organisms in this appendix which are not select agents.

Biosafety Levels - Biosafety levels (BSL) refer to the combination of laboratory practices and techniques, safety equipment and laboratory facilities under which the project can be conducted safely. There are four biosafety levels (1-4). The risk group an agent is classified under, attenuation or inactivation of the agent, the type of work being conducted, and the amount of the agent being used are all factors used in determining the biosafety level assessment.

Priority Levels - Priority levels were assigned by CDC and NIAID to some select agents and other infectious agents based on the criteria listed below. Although, the agents assigned to category A, B, and C are the same for both the CDC and NIAID, the NIAID also took into account the potential for the agent to be weaponized, the lack of a safe and effective vaccine, and the lack of specific diagnostic tests and/or effective treatments in assigning a priority category to agents. Moreover, the NIAID Strategic Plan for Biodefense Research (February 2002) specifically stated that the plan should not be limited by preexisting CDC lists when assigning priority categories and should remain flexible and based on the characteristics that make an agent a feasible threat to civilian populations. Some agents listed under category B are not select agents (e.g., food and water-borne pathogens).

Category A - Highest Priority. These are based on the threat to public safety and the potential for use as weapons for bioterrorism. These agents can be easily disseminated or transmitted from person to person; result in high mortality rates and have the potential for major public health impact; might cause public panic and social disruption; and require special action for public health preparedness.
Category B - Second Highest Priority- These agents are moderately easy to disseminate; result in moderate morbidity rates and low mortality rates; and require specific enhancement of diagnostic capacity and enhanced disease surveillance.
Category C - Third Highest Priority- These agents include emerging pathogens that could be engineered for mass dissemination in the future because of availability; ease of production and dissemination; and potential for high morbidity and mortality rates and major health impact.

Restricted Agents - This terms refers to select agents and is used in the NIH Guidelines.

4. What actions must I take if I want to use a select agent in my research?
Any investigator contemplating the use of a select agent in their research within the next year should contact the UIC Environmental Health and Safety Office (EHSO) at 996-7411 to begin the process of select agent registration. The process can be lengthy, requires background checks of all personnel that will have access to the agent, and may require remodeling of laboratory space. DO NOT WAIT TO BEGIN THIS PROCESS!!! Listed below are a number of issues that must be considered prior to completion of the registration process and additional units on campus that must be contacted.

Registration of entity (Section 1 and 2 of registration form)
This applies to registration of the institution. Federal law requires that each institution that will use, possess, or transfer select agents be registered. UIC is a registered institution with both the CDC and USDA. The entity must also identify a Responsible Official (RO), and alternative RO. These individuals are responsible for ensuring management oversight of the implementation of the select agent regulations and they provide a point of contact for the entity.

Registration of agent (Section 3 and 4A of registration form)
Each agent that will be used, possessed by, or transfer to or from an entity must be registered and the principle investigator using, possessing, or transferring each specific agent must be identified.

Biosafety level evaluation (Section 4A of registration form)
For each agent/investigator/laboratory facility- the following information must be provided. The EHSO will assist investigators in completing this portion of the application

Agent/Toxin Name
Facility Agent ID (e.g., specific identification used to identify a specific agent, toxin or derivative at that facility)
Form of the agent being used and type of use (e.g., viable, rDNA, genomic, toxin, small animal use, large animal use, or large scale production)
Location of Use and Storage- the laboratory room and bldg and the storage room and bldg must be identified
Laboratory Safety Level- This is the biosafety assigned to the specific use and form of the agent for a specific investigator and specific laboratory.

Facility evaluation (Section 5 of registration form)
Each investigator for each laboratory must complete the laboratory information section. The EHSO along with additional units (underlined) will assist investigators with this process. The laboratory information is a detailed description of the following:

Agent Specific Information (these questions need to be answered for each principle investigator/laboratory supervisor) - Agent Name, Strain Designation, Date Acquired, Address of Facility from which Agent/Toxin was Acquired and Select Agent Registration number, if applicable, Facility Agent ID, Source of Isolate, Unique Diagnostic Characteristics, Reference to Published Sequence information, and Host Range.
Laboratory Specific Information (these questions need to be answered for each laboratory room where select agents are used or stored. If all laboratories with the same biosafety level under the control of one principle investigator/laboratory supervisor meet the same criteria, then all laboratory rooms may be listed on one form and only one form needs to be submitted). Many of these questions will require working with EHSO, UIC police, UIC facility management, BRL, the IBC, and the ACC. In addition,
1. Floor plans (identifying location of fume hoods, eyewash stations, sinks, biosafety cabinets, freezers, centrifuges, etc.)
2. HVAC system
3. Biosafety cabinets
4. BSL3 specific questions
5. ABSL2 or ABSL3 animal specific questions. In addition to completion of this information on select agent application, submission and approval of a protocol by UIC ACC is required. Contact the ACC office.
6. Safety - procedures, equipment, waste disposal, accidental spills and training (what, when, how, proficiency, documentation). An SOP should be developed for each laboratory handling select agents. Training will be conducted by UIC Biosafety officer.
7. Security/Access - In addition to the Background check conducted by the Department of Justice, each lab must have a site-specific security assessment conducted by the UIC police. Investigators should contact Demetruis Anderson at 355-3466 when they begin the select agent registration process. This will include assessing the security of the facility, security of the agent, and security of the data, as well as, key card assess to approved personnel. Training on security procedures must also be documented.
8. Recordkeeping practices - Inventory control and report of theft, loss, or release of select agents or toxins- Each laboratory must maintain a log of use/destruction of the agent. If a loss, theft or release of the select agent is detected, the investigator must immediately contact EHSO to report it. The theft, loss or release must be reported immediately by telephone to the appropriate agencies by the RO and within 7 calendar days a form (CDC 0.1316/APHIS 2043) must be completed by the RO and sent to the appropriate agency.
9. Infectious agent specific questions. In addition to completion of this information on select agent application, submission and approval of a protocol by UIC IBC is required. Contact the IBC office.
10. rDNA specific questions. In addition to completion of this information on select agent application, submission and approval of a protocol by UIC IBC is required. Contact the IBC office.
11. Toxin specific questions. In addition to completion of this information on select agent application, submission and approval of a protocol by UIC IBC is required. Contact the IBC office.

Background check of Personnel
A background check of all personnel who will work with or have access to any select agent is required. Department of Justice (DOJ) forms must be completed and each researcher must be fingerprinted. Only personnel approved by the DOJ will be allowed access to select agents.

Health Related Issues
medical surveillance, vaccination requirements, and knowledge of signs and symptoms of exposure. In addition to contacting the EHSO, investigators should discuss these issues with University Health Service Director, David Marder (996-7420).

5. How do I ship or receive a select agent?
Contact EHSO at 996-7411 to complete this process. All shipping and receiving of select agents must be done by the EHSO and may only be done between registered entities. The CDC FORM EA101 / APHIS FORM 2041 - Report of Transfer of Select Biological Agents and Toxins must be completed. Portions of this form need to be filled out by both the recipient RO and the sender RO. The sequence for completing this form (who, what and when) is shown below. In addition, if investigators are planning on obtaining select agents from outside the United States, an APHIS import permit must be obtained.

Requestor RO - complete block 1 - requestor (recipient) information

Entity name
Entity Registration number(s)
Recipient name and contact information (must be registered)
Principle investigator name and contact information (if different from recipient)
Requestor RO name and contact information

Requestor RO - Complete block 2- select agent description

Indicate if organism, toxin, and/or rDNA organism/molecules with appropriate strain/type information.
Indicate intended use: research, diagnostic, production, other (explain)

Requestor RO - Fax form and registration certificate to sender.

Sender RO - complete block 3- sender (transferor) information

Entity name
Entity Registration number(s)
Sender name and contact information (must be registered)
Principle investigator name and contact information (if different from sender)
Sender RO name and contact information

Sender RO - fax form to CDC or APHIS to obtain verification number.

Sender RO - once CDC or APHIS approval is obtained- complete block 4 (except for date of receipt)- shipping information

Select agent
Characterization of agent
Number of vials
Form of agent
Amount per vial
Total Amount
Concentration/vial
Number of primary receptacles/outer packages
Number of outer packages
Carrier and waybill tracking number
Shipping Date
A return receipt may also be required for some select agents.

Sender RO - oversees packaging and shipment of agent to recipient. Sends shipment.

Recipient RO - Receives agent

Recipient RO - Complete block 4

Enter date of receipt
Verify that what was shipped was received
Within 2 business days provide fax or paper copies of completed form to CDC or APHIS and sender RO.

Sender and Recipient RO - retain paper record for 3 years, or retain record 3 years after agent consumed or destroyed, which ever is longer. When the select agent from a transfer is depleted or destroyed, the RO of the facility must complete the appropriate information in block 4 of the form and fax a copy of the form to the CDC or APHIS.

6. How do I gain key card access to a select agent facility?
All researchers who will be working with select agents must complete the select agent registration process, complete the background security check with the FBI and complete a security risk assessment with the UIC Police by contacting Demetruis Anderson at 355-3466. Key card assess must be approved by the UIC Police.

7. Are there any additional approvals needed?
Any investigator using rDNA, infectious agent and/or a toxin, regardless of whether these items are select agents, must complete an Institutional Biosafety Committee protocol. Policies, instructions and protocol forms can be found on the IBC web site. Investigators should contact the IBC office with questions.

8. How long does registration last?
Registration lasts for three years. Registration will need to be renewed for any investigator who wishes to continue working with select agents. If at that time the investigator is no longer working with the select agent, but still possesses it, then registration must be renewed.

9. What if changes in my research occur related to select agent use?
Any change (e.g., how the agent is being used, how much, where, by whom, etc.) in the use of a select agent must be reported to the EHSO (996-7411) prior to initiation of the change. This is essential to determine if an amended registration is necessary. In addition, changes in select agent use should be reported to the IBC (996-7427) prior to initiation to determine if a modification of the IBC protocol must be approved.

Frequently Asked Questions

Select Agents | Select Agent Risk Group Comparison