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Select Agent Program

The Biosafety Compliance Office provides oversight for the University of Hawaiʻi Select Agent Program. Select Agent Regulations (42 CFR Part 72, 6 CFR Part 331, 9 CFR Part 221) and the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 require all persons who have access to, possession or use select agents or toxins to be registered with the Select Agent Program (USDA/APHIS or CDC).

To determine if the agents or toxins you intend to conduct research activities with are regulated by the select agent program, review the list of select agents and toxins at this link:

http://www.selectagents.gov/Select%20Agents%20and%20Toxins%20List.html

Research activity involving any of the following will also require Intergovernmental Select Agents and Toxins Technical Advisory Committee (ISATAC) approval (42CFR 73.13);

  1. Experiments with rDNA involving the deliberate transfer of a drug resistance trait to select agents that are not known to acquire the trait naturally, if such acquisition could compromise the use of the drug to control disease agents in humans, veterinary medicine or agriculture.
  2. Experiments involving the deliberate formation of rDNA containing genes for the biosynthesis of select toxins lethal for vertebrates at an LD50 <100ng/kg body weight.
  Who should register with the program?
42 CFR 73.10.

  1. Any person who has access to the select agent/toxins (ability to carry, use or manipulate)

  2. Any person who is able to gain possession of a select agent or toxins

  3. Any person who would like to conduct research activities with the agents/toxins

  4. Any person who has access to Select Agent Sensitive Information – information too sensitive to be released to the public and includes information related to select agents, security related information, human resources specific information on individuals who are in the UH select agent program. Examples include

  1. List of individuals with access to select agents

  2. Training records for individuals with access to select agents

  3. Select agent inventory records

  4. Permits and transfer documents

  5. Visitor logs, databases and lab records associated with select agents.

  6. Documentation concerning select agents such as what may be found on the AHIS/CDC Form 1, 2, 3, 4
  What are the requirements to be to participate in the program?
42 CFR 73.10 (c) Individual with access to select agents or toxins must have appropriate education, training and/or experience to handle or use such agents or toxins.

  1. Complete all applicable Biosafety Compliance Program Training Courses
  1. General Biosafety

  2. Bloodborne Pathogens

  3. Transportation of Biological and Infectious Substances

  1. Complete the mandatory UH select Agent Training

  1. Online in Laulima (Annual) – Regulations, Biosafety, Biosecurity

  2. In classroom 1-3 courses per year

  1. Receive appropriate IBC, IACUC and or CHS Approval
  How do I register with the UH Select Agent Program?
  1. The Principal Investigator/ Lab Manager should notify the Alternate Responsible Official by providing the name of the person(s), the email and phone numbers and the reason for addition of the individual. (Note: For Kaka'ako; you must receive approval from Lab Director )

  2. Complete all applicable UH Biosafety Program Training

  3. Complete the Laulima Select Agent Training. (To gain access to the site; you must have approval from the Lab Director and or PI. You will be notified of access once the Lab Director or PI notifies the ARO)

  4. Contact the State of Hawaiʻi Criminal Justice Data Center and arrange for a Fingerprinting session 587-3279, 586-2820 (The cost is 10.00 Cash only)

  5. Complete the FD961 form

  6. Form-fd-961

    NOTE: SKIP QUESTION 11.

  7. Submit the fingerprint card(s) and completed FD 961 forms to the ARO.

  8. The ARO for the University of Hawaiʻi will submit all select agent registrations to the appropriate Select Agent Program (USDA/APHIS or CDC).
  UH Select Agent Training
Training on bio-containment, security, select agent regulations, general biosafety principles and practices is provided in classroom or online through laulima and must be completed annually.

Note: Access to the UH Select Agent Program site is restricted to researchers and staff preparing for enrollment and who are currently enrolled in the UH Select Agent Program. Contact Us for access and additional information.

Online

The following modules are provided as an online annual training and in classroom semiannual training. You must successfully pass the Online and classroom trainings to receive continued access to the Select agents and maintain status in the UH Select Agent Program.
  1. Biosafety Level 3 Principles and Practices (if applicable)
  2. Select Agent Regulations
  3. Select Agent Biosecurity
  4. Successful completion of the online training is determined by receiving a passing grade (75% or greater) on the quiz.

Classroom

Training is provided throughout the year on biosecurity, regulations and biosafety training. All members of the UH Select agent program will be notified of the additional training.

Successful completion of the classroom trainings will be determined from an interactive question and answer session and or written quiz.

 

Contact Us

Office of the Vice Chancellor for Research
University of Hawaiʻi at Mānoa
Biosafety Compliance Program
1960 East-West Road, Biomed T110
Honolulu, HI 96822
808-956-0347